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Jeyaraman N, Jeyaraman M, Ramasubramanian S, Balaji S, Muthu S. Voices that matter: The impact of patient-reported outcome measures on clinical decision-making. World J Methodol 2025; 15:98066. [DOI: 10.5662/wjm.v15.i2.98066] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/17/2024] [Revised: 09/09/2024] [Accepted: 09/25/2024] [Indexed: 11/27/2024] Open
Abstract
The critical role of patient-reported outcome measures (PROMs) in enhancing clinical decision-making and promoting patient-centered care has gained a profound significance in scientific research. PROMs encapsulate a patient's health status directly from their perspective, encompassing various domains such as symptom severity, functional status, and overall quality of life. By integrating PROMs into routine clinical practice and research, healthcare providers can achieve a more nuanced understanding of patient experiences and tailor treatments accordingly. The deployment of PROMs supports dynamic patient-provider interactions, fostering better patient engagement and adherence to treatment plans. Moreover, PROMs are pivotal in clinical settings for monitoring disease progression and treatment efficacy, particularly in chronic and mental health conditions. However, challenges in implementing PROMs include data collection and management, integration into existing health systems, and acceptance by patients and providers. Overcoming these barriers necessitates technological advancements, policy development, and continuous education to enhance the acceptability and effectiveness of PROMs. The paper concludes with recommendations for future research and policy-making aimed at optimizing the use and impact of PROMs across healthcare settings.
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Affiliation(s)
- Naveen Jeyaraman
- Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, TN 600077, India
- Department of Research Methods, Orthopaedic Research Group, Coimbatore, TN 641045, India
| | - Madhan Jeyaraman
- Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, TN 600077, India
- Department of Research Methods, Orthopaedic Research Group, Coimbatore, TN 641045, India
| | - Swaminathan Ramasubramanian
- Department of Orthopaedics, Government Medical College, Omandurar Government Estate, Chennai, TN 600002, India
| | - Sangeetha Balaji
- Department of Orthopaedics, Government Medical College, Omandurar Government Estate, Chennai, TN 600002, India
| | - Sathish Muthu
- Department of Research Methods, Orthopaedic Research Group, Coimbatore, TN 641045, India
- Department of Biotechnology, Faculty of Engineering, Karpagam Academy of Higher Education, Coimbatore, TN 641021, India
- Department of Orthopaedics, Government Medical College, Karur, TN 639004, India
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Mallow J, Bailey A, Tasker L, Hazard H, Hassett M, Cronin C, Paudel R, Bian J, Dizon DS, Osarogiagbon RU, Schrag D, Wong SL. Perceptions of an Electronic Patient Symptom Reporting Tool by Clinicians. Comput Inform Nurs 2025:00024665-990000000-00339. [PMID: 40257368 DOI: 10.1097/cin.0000000000001313] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/22/2025]
Abstract
Prior to implementing an electronic health record-integrated patient-reported outcomes system, eSyM, the perceived facilitators and barriers to implementation from multiple stakeholder perspectives were sought. The purpose is to report the findings of the perceived facilitators and barriers to implementation of eSyM from multiple clinician stakeholder perspectives. Stakeholders included administrators, clerical staff, information technology professionals, support staff, physicians, providers, and nurses from six Symptom Management Implementation of Patient-Reported Outcomes in Oncology health systems, a diverse mix of academic/community, rural/metropolitan, and Northeastern and Southern community-based cancer centers. Site information, participant information, perceived effectiveness, and perceived patient barriers to use were collected from 173 stakeholders. RNs were the most represented participants, followed by physicians, physician assistants, and nurse practitioners. Stakeholders felt that eSyM would be effective in improving patient symptom management, keeping patients out of the hospital and emergency department, and improving clinic efficiency. Clinician stakeholders perceived eSyM as necessary and effective for improving symptom management. Most stakeholders felt that their colleagues would be supportive of using eSyM. Stakeholders perceived minor patient barriers were access to technology, distrust of technology, and English language proficiency. Computer literacy was perceived as a major barrier. Future longitudinal mixed-methods design that combines quantitative findings with qualitative observations is needed. Understanding the contextual factors that influence the facilitation or barriers of implementing eSyM is needed to scale and spread the intervention to other institutions. As a nursing intervention, the assessment of the perceptions of improvement of eSyM workflow would be especially useful.
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Affiliation(s)
- Jennifer Mallow
- Author Affiliations: 9620 Health Sciences South (Dr Mallow); and School of Nursing (Ms Bailey) and Cancer Institute (Ms Tasker, Dr Hazard), West Virginia University, Morgantown; Dana-Farber Cancer Institute, Boston, MA (Dr Hassett, Ms Cronin, Dr Paudel); Maine Medical Center, Portland, ME (Dr Bian); Lifespan Cancer Institute and Legorreta Cancer Center at Brown University, Providence, RI (Dr Dizon); Baptist Cancer Center, Memphis, TN (Dr Osarogiagbon); Memorial Sloan Kettering Cancer Center, New York (Dr Schrag); and Dartmouth Hitchcock Medical Center, Lebanon, NH (Dr Wong)
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Bennett P, Warren M, Aydin Z, Beige J, Bowes E, Cheung M, Finderup J, Gallego D, Hecking M, Hurst H, King JM, Kleophas W, Liossatou A, Martins P, Masià-Plana A, Meuleman Y, Neri L, Noruišienė E, Ortiz J, Rix M, Stuard S, Tsukamoto Y. Kidney Disease: Improving Global Outcomes (KDIGO) Workshop on the Nurse's Role in Managing the Symptoms of People Receiving Dialysis. Kidney Int Rep 2025; 10:313-320. [PMID: 39990881 PMCID: PMC11843113 DOI: 10.1016/j.ekir.2024.11.029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2024] [Revised: 11/15/2024] [Accepted: 11/19/2024] [Indexed: 02/25/2025] Open
Abstract
Adults with kidney failure receiving dialysis frequently report high symptom burden that can limit life participation and decrease the quality of life. Fatigue, itch, pain, anxiety, depressive symptoms, sleep problems, nausea, vomiting, muscle cramps, breathlessness, and decreased cognition can negatively impact important daily activities. Nurses are the majority health professional group that provides care for people receiving dialysis and have a major role in managing these symptoms. However, routine symptom management by nurses is not universal or standardized in dialysis care. In December of 2023, Kidney Disease: Improving Global Outcomes (KDIGO) held a workshop on the Nurse's Role in Managing the Symptoms of People Receiving Dialysis. The discussions focused on the current barriers nurses face when identifying and assessing symptoms, strategies for identifying symptoms, and the ongoing monitoring and management of symptoms. Nephrology nurses are pivotal in supporting the person with kidney failure receiving dialysis to minimize symptoms, optimize symptom management, decrease dialysis treatment burden, and improve life participation and quality of life.
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Affiliation(s)
- Paul Bennett
- Griffith University, Brisbane, Queensland, Australia
| | | | | | | | | | - Michael Cheung
- Kidney Disease: Improving Global Outcomes, Brussels, Belgium
| | | | | | - Manfred Hecking
- KfH, Neu-Isenburg, Germany
- Medical University of Vienna, Vienna, Austria
| | | | | | | | - Anastasia Liossatou
- Haemodialysis Unit, Kefalonia General Hospital, Argostoli, Greece
- European Dialysis and Transplant Nurses Association/European Renal Care Association, Hergiswil, Switzerland
| | - Pedro Martins
- Clinica de Hemodialise do Porto, Fresenius Medical Care, Portugal
- University of Maia, Maia, Portugal
| | - Afra Masià-Plana
- Department of Nursing, Universitat de Girona, Girona, Catalonia, Spain
| | - Yvette Meuleman
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | | | - Edita Noruišienė
- European Dialysis and Transplant Nurses Association/European Renal Care Association, Hergiswil, Switzerland
| | | | - Marianne Rix
- Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
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Rydell H, Caldinelli A, Wrackefeldt J, Kåveryd-Hult A, Lindholm B, Qureshi AR, Chesnaye NC, Evans M. Quality of life trajectories for different dialysis modalities-a nationwide study. Clin Kidney J 2025; 18:sfae420. [PMID: 39968507 PMCID: PMC11833710 DOI: 10.1093/ckj/sfae420] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2024] [Indexed: 02/20/2025] Open
Abstract
Background Few contemporary studies have investigated the changes in quality of life across dialysis modalities. Our aim was to compare longitudinal changes in health-related physical and mental quality of life between patients on institutional hemodialysis (IHD), peritoneal dialysis (PD) and home hemodialysis (HHD). Methods Patients on dialysis with registered Research and Development 36 (RAND-36) questionnaires between 2017-2021 in the Swedish Renal Registry (SRR) were eligible for inclusion. Information on dialysis, patient characteristics and medication were collected from SRR and other registries. Patients were followed up to 39 months. Changes in physical (PCS) and mental (MCS) component summary scores were analyzed in adjusted linear mixed models and joint models. Results We included 930 patients (IHD 714, PD 128, HHD 88) with a median follow-up of 1.8 years (interquartile range 1.0-2.1). At baseline, the mean unadjusted PCS was lower in IHD (30.7; 95% CI 29.9, 31.4) compared with HHD (35.3; 95% CI 33.0, 37.5) and PD (33.2; 95% CI 31.3, 35.1). PCS declined over time in all modalities, but faster for PD compared with IHD (-1.2; 95% CI -2.1, -0.3 per year) and HHD (-1.5, 95% CI -2.9, -0.04). MCS was similar at baseline. HHD had improving MCS trajectory compared to IHD (-1.5, 95% CI -2.8, 0.2) and PD (-2.3, 95% CI -3.9, 0.7), largely resulting from improvement in role limitations caused by mental health (6.2, 95% CI 0.9, 11.5). Conclusion Insights about the variation in quality-of-life trajectories for different dialysis modalities are important for patients to make informed choices.
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Affiliation(s)
- Helena Rydell
- Renal Medicine, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden
- Renal unit, Karolinska University Hospital, Stockholm, Sweden
- Swedish Renal Registry, Jönköping, Sweden
| | - Aurora Caldinelli
- Department of Medical Epidemiology and Biostatistics (MEB), Karolinska Institutet, Solna, Sweden
| | - Jenny Wrackefeldt
- Renal Medicine, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden
- Renal unit, Karolinska University Hospital, Stockholm, Sweden
| | - Aline Kåveryd-Hult
- Swedish Renal Registry, Jönköping, Sweden
- Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Bengt Lindholm
- Renal Medicine, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden
| | - Abdul Rashid Qureshi
- Renal Medicine, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden
| | - Nicholas C Chesnaye
- ERA Registry, Amsterdam UMC location University of Amsterdam, Medical Informatics, Meibergdreef 9, Amsterdam, The Netherlands
- Amsterdam Public Health Research Institute, Quality of Care, Amsterdam, The Netherlands
| | - Marie Evans
- Renal Medicine, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden
- Renal unit, Karolinska University Hospital, Stockholm, Sweden
- Swedish Renal Registry, Jönköping, Sweden
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Migliorini F, Maffulli N, Jeyaraman M, Schäfer L, Rath B, Huber T. Minimal clinically important difference (MCID), patient-acceptable symptom state (PASS), and substantial clinical benefit (SCB) following surgical knee ligament reconstruction: a systematic review. Eur J Trauma Emerg Surg 2025; 51:32. [PMID: 39843864 DOI: 10.1007/s00068-024-02708-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/16/2024] [Accepted: 10/21/2024] [Indexed: 01/24/2025]
Abstract
INTRODUCTION The minimal clinically important difference (MCID), patient-acceptable symptom state (PASS), and substantial clinical benefit (SCB) are designed to prioritise clinically significant outcomes that demonstrate true clinical benefit rather than relying solely on statistical significance. These instruments aid clinicians in understanding the patient's perspective, allowing healthcare professionals to set treatment goals that align with patients' desires and expectations. This systematic review analysed tools to estimate the clinical relevance of the most commonly used PROMs to assess patients following surgical knee ligament reconstruction. METHODS This study was conducted according to the 2020 PRISMA statement. In January 2024, the following databases were accessed: PubMed, Web of Science, and Embase. No time constraint was set for the search. All the clinical studies investigating tools to assess the clinical relevance of PROMs in knee ligament surgery were accessed. Only studies which evaluated the MCID, PASS, and SCB were eligible. The PROMs of interest were: International Knee Document Committee (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS) and its related subscales activity of day living (ADL), pain, quality of life (QoL), sport and recreational, and symptoms (Roos et al. in J Orthop Sports Phys Ther 28:88-96, 1998), Lysholm knee scoring scale, Short Form 12 (SF-12) and its related mental and physical component subscales, Tegner Activity Scale. RESULTS Seven non-RCT investigations, three with a prospective and four with a retrospective study design, were selected for inclusion in the present review, including 1,414 patients. The overall risk of bias was low to moderate in 71.4% (5 of 7) and serious in 28.6% (2 of 7) of the studies assessed in the present investigation, indicating a broadly acceptable methodological quality. The IKDC reported an MCID of 13.8/100, the KOOS 8.0/100, the Lysholm 9.9/100, and the Tegner Activity Scale 0.5/10. CONCLUSION This systematic review demonstrated that more dependable scientific data, appropriate study methodology, and adequate reporting of MCID, SCB, and PASS in surgical knee ligament reconstruction is necessary. The IKDC score, the Lysholm score, and the Tegner activity scale were the only instruments with multiple studies reporting values. Level of evidence Level IV, systematic review and meta-analysis.
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Affiliation(s)
- Filippo Migliorini
- Department of Life Sciences, Health, and Health Professions, Link Campus University of Rome, Rome, Italy
- Department of Orthopedics and Trauma Surgery, Academic Hospital of Bolzano (SABES-ASDAA), 39100, Bolzano, Italy
| | - Nicola Maffulli
- Department of Medicine and Psychology, University of Rome La Sapienza, Rome, Italy.
- School of Pharmacy and Bioengineering, Faculty of Medicine, Keele University, Stoke on Trent, ST4 7QB, UK.
- Centre for Sports and Exercise Medicine, Barts and the London School of Medicine and Dentistry, Mile End Hospital, Queen Mary University of London, 275 Bancroft Road, London, E1 4DG, England, UK.
| | - Madhan Jeyaraman
- Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, India
| | - Luise Schäfer
- Department of Life Sciences, Health, and Health Professions, Link Campus University of Rome, Rome, Italy
| | - Björn Rath
- Department of Orthopaedic, Clinic of Wels-Grieskirchen, 4600, Wels, Austria
| | - Thorsten Huber
- Department of Orthopaedic, Clinic of Wels-Grieskirchen, 4600, Wels, Austria
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Anwar FN, Wolf JC, Roca AM, Loya AC, Medakkar SS, Kaul A, Federico VP, Sayari AJ, Lopez GD, Singh K. Validation of PROMIS-PI in a Lumbar Decompression Cohort Through Correlation to Established Pain and Disability Metrics. Clin Spine Surg 2024:01933606-990000000-00423. [PMID: 39718212 DOI: 10.1097/bsd.0000000000001717] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2024] [Accepted: 09/23/2024] [Indexed: 12/25/2024]
Abstract
STUDY DESIGN Retrospective review. OBJECTIVE To validate using patient-reported outcome measurement information system-pain interference (PROMIS-PI) to assess outcomes in patients undergoing lumbar decompression surgery compared with well-established pain and disability measures. SUMMARY OF BACKGROUND DATA PROMIS outcomes provide valuable information, but the PROMIS-PI measure has not been validated in lumbar decompression. METHODS Patient data from a single-surgeon registry were queried to identify patients undergoing elective, primary lumbar decompression for disc herniation. Exclusion criteria included records missing patient-reported outcome measures (PROMs). PROMs included: PROMIS-PI, visual analog scale (VAS)-back, VAS-leg, and Oswestry disability index (ODI). The association between PROMIS-PI and the other PROMs was determined at preoperative, 6-week, 12-week, 6-month, 1-year, and 2-year time points using the Pearson paired correlation tests. MCID achievement rates were determined for all PROMs and correlations were calculated between PROMIS-PI MCID achievement rates and achievement rates for VAS-B, VAS-L, and ODI. RESULTS A total of 102 patients were included. PROMIS-PI demonstrated a significant correlation to VAS-B at all periods (P<0.0048, all) with a magnitude of correlation (|r|) ranging from 0.535 to 0.907. PROMIS-PI demonstrated a significant correlation to VAS-L at all periods (P<0.0048, all) with a magnitude of correlation (|r|) ranging from 0.393 to 0.907. PROMIS-PI demonstrated a significant correlation to ODI (P<0.0010, all) with a magnitude of correlation (|r|) ranging from 0.664 to 0.925. There were moderate correlations between MCID achievement rates between PROMIS-PI and all other PROMs studied (P<0.0019, all) with correlation coefficients ranging from 0.367 to 0.406. CONCLUSION PROMIS-PI demonstrated a significant correlation to VAS-back, VAS-L, and ODI metrics at preoperative and all postoperative follow-up periods. PROMIS-PI as a valid tool for the evaluation of patient-reported pain provides an additional metric that can guide pain management in patients undergoing spine surgery.
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Affiliation(s)
- Fatima N Anwar
- Department of Orthopaedic Surgery, Rush University Medical Center
| | - Jacob C Wolf
- Chicago Medical School at Rosalind Franklin University of Medicine and Science, North Chicago, IL
| | - Andrea M Roca
- Department of Orthopaedic Surgery, Rush University Medical Center
| | - Alexandra C Loya
- Department of Orthopaedic Surgery, Rush University Medical Center
| | | | - Aayush Kaul
- Chicago Medical School at Rosalind Franklin University of Medicine and Science, North Chicago, IL
| | | | - Arash J Sayari
- Department of Orthopaedic Surgery, Rush University Medical Center
| | - Gregory D Lopez
- Department of Orthopaedic Surgery, Rush University Medical Center
| | - Kern Singh
- Department of Orthopaedic Surgery, Rush University Medical Center
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Bjørgen Winther S, Sjøstrøm A, Liabakk-Selli S, Foss OA, Wik TS, Klaksvik J. Can KOOS-PS be replaced with a simple anchor question in patients after total knee arthroplasty?: an agreement study of 2,478 primary surgeries. Acta Orthop 2024; 95:639-644. [PMID: 39531519 PMCID: PMC11558857 DOI: 10.2340/17453674.2024.42098] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/05/2024] [Accepted: 09/20/2024] [Indexed: 11/16/2024] Open
Abstract
BACKGROUND AND PURPOSE Physical function and pain are the most important outcomes following total knee arthroplasty (TKA). These can be evaluated by patient-reported outcome measures (PROMs), or by an anchor question. The primary aim of the study was to evaluate whether a simple anchor question can replace KOOS-PS in assessing postoperative knee function until 1-year follow-up, evaluated by analyzing the agreement between the 2 methods using the diagnostic odds ratio (DOR). Secondary aims were pain (NRS) at rest and during mobilization. METHODS This is a diagnostic accuracy study with primary TKAs performed between 2010 and 2022. The surgeries were categorized as improved (I) or worsened (W) based on a dichotomized anchor question related to self-perceived change in physical function, and the dichotomized change in KOOS-PS until 1-year follow-up. This led to 4 groups: (II, IW, WI, and WW). RESULTS Agreement was found with a DOR of 11.3 (CI 7.9-16.2). 2,335 (94%) reported improved function on the anchor question and 143 (6%) worsened function. Among those with improved anchor 2,132 (91%) had improved KOOS-PS, but among those with worsened anchor only 74 (52%) had worsened KOOS-PS. Pain at 1-year follow-up was lower in the groups reporting improved anchor. CONCLUSION The KOOS-PS can be replaced with an anchor question to assess change in function until 1 year. However, the KOOS-PS might be a valuable supplement in patients reporting worsened anchor as only half of those had worsened KOOS-PS.
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Affiliation(s)
- Siri Bjørgen Winther
- Department of Orthopedic Surgery, St. Olav's Hospital HF, Trondheim; Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, Norwegian University of Science and Technology NTNU, Trondheim, Norway.
| | - Anders Sjøstrøm
- Department of Orthopedic Surgery, St. Olav's Hospital HF, Trondheim, Norway
| | | | - Olav A Foss
- Department of Orthopedic Surgery, St. Olav's Hospital HF, Trondheim, Norway
| | - Tina S Wik
- Department of Orthopedic Surgery, St. Olav's Hospital HF, Trondheim; Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, Norwegian University of Science and Technology NTNU, Trondheim, Norway
| | - Jomar Klaksvik
- Department of Orthopedic Surgery, St. Olav's Hospital HF, Trondheim, Norway
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Legemate CM, Middelkoop E, Carrière ME, van Zuijlen PPM, van Baar ME, van der Vlies CH. The minimal important change (MIC) and minimal clinically important difference (MCID) of the patient and observer scar assessment scale (POSAS) 2.0. Burns 2024; 50:2070-2076. [PMID: 38902132 DOI: 10.1016/j.burns.2024.05.022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/25/2023] [Revised: 05/11/2024] [Accepted: 05/28/2024] [Indexed: 06/22/2024]
Abstract
BACKGROUND The Patient and Observer Scar Assessment Scale (POSAS) is frequently used to assess scar quality after burns. It is important to be aware of the minimal important change (MIC) and the minimal clinically important difference (MCID) to establish if a POSAS score represents a clinically relevant change or difference. The aim of this study is to explore the MIC and MCID of POSAS version 2.0. METHODS This prospective study included 127 patients with deep dermal burns that underwent split thickness skin grafting with a mean age of 44 years (range 0 - 87) and total body surface area burned of 10 % (range 0.5 - 55). POSAS data was obtained for one burn scar area at three, six, and 12 months after split skin grafting. At the second and third visits, patients rated the degree of clinical change in scar quality in comparison to the previous visit. At 12 months, they completed the POSAS for a second burn scar area and rated the degree of clinical difference between the two scar areas. Two anchor-based methods were used to determine the MIC and MCID. RESULTS MIC values of the patient POSAS ranged from - 0.59 to - 0.29 between three and six months and from - 0.75 to - 0.38 between six and 12 months follow-up. Both had a poor discriminatory value. MCID values ranged from - 0.39 and - 0.08, with a better discriminatory value. CONCLUSION Results suggest that patients consider minor differences (less than 0.75 on the 1-10 scale) in POSAS scores as clinically important scar quality changes. MCID values can be used to evaluate the effects of burn treatment and perform sample-size calculations.
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Affiliation(s)
- Catherine M Legemate
- Burn Centre, Maasstad Hospital, Rotterdam, the Netherlands; Department of Plastic, Reconstructive and Hand Surgery, Amsterdam UMC, Amsterdam Movement Sciences, Vrije Univeristeit Amsterdam, Amsterdam, the Netherlands.
| | - Esther Middelkoop
- Department of Plastic, Reconstructive and Hand Surgery, Amsterdam UMC, Amsterdam Movement Sciences, Vrije Univeristeit Amsterdam, Amsterdam, the Netherlands; Association of Dutch Burn Centres, Red Cross Hospital, Beverwijk, the Netherlands
| | - Michelle E Carrière
- Department of Plastic, Reconstructive and Hand Surgery, Amsterdam UMC, Amsterdam Movement Sciences, Vrije Univeristeit Amsterdam, Amsterdam, the Netherlands; Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Noord-Holland, the Netherlands; Burn Center and Department of Plastic, Reconstructive and Hand Surgery, Red Cross Hospital, Beverwijk, Noord-Holland, the Netherlands
| | - Paul P M van Zuijlen
- Department of Plastic, Reconstructive and Hand Surgery, Amsterdam UMC, Amsterdam Movement Sciences, Vrije Univeristeit Amsterdam, Amsterdam, the Netherlands; Burn Center and Department of Plastic, Reconstructive and Hand Surgery, Red Cross Hospital, Beverwijk, Noord-Holland, the Netherlands; Pediatric Surgical Centre, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Vrije Universiteit, Amsterdam, the Netherlands
| | - Margriet E van Baar
- Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands; Association of Dutch Burn Centres, Maasstad Hospital, Rotterdam, the Netherlands
| | - Cornelis H van der Vlies
- Burn Centre, Maasstad Hospital, Rotterdam, the Netherlands; Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands
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Sørensen RR, Timm S, Rasmussen LE, Brasen CL, Varnum C. Metabolic syndrome and patient-reported outcome two years after hip and knee arthroplasty. Bone Joint J 2024; 106-B:1074-1083. [PMID: 39348914 DOI: 10.1302/0301-620x.106b10.bjj-2024-0087.r1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/02/2024]
Abstract
Aims The influence of metabolic syndrome (MetS) on the outcome after hip and knee arthroplasty is debated. We aimed to investigate the change in patient-reported outcome measure (PROM) scores after hip and knee arthroplasty, comparing patients with and without MetS. Methods From 1 May 2017 to 30 November 2019, a prospective cohort of 2,586 patients undergoing elective unilateral hip and knee arthroplasty was established in Denmark. Data from national registries and a local database were used to determine the presence of MetS. Patients' scores on Oxford Hip Score (OHS) or Oxford Knee Score (OKS), EuroQol five-dimension five-level questionnaire (EQ-5D-5L), University of California, Los Angeles (UCLA) Activity Scale, and Forgotten Joint Score (FJS) at baseline, three, 12, and 24 months after surgery were collected. Primary outcome was the difference between groups from baseline to 12 months in OHS and OKS. Secondary outcomes were scores of OHS and OKS at three and 24 months and EQ-5D-5L, UCLA Activity Scale, and FJS at three, 12, and 24 months after surgery. Generalized linear mixed model was applied, adjusting for age, sex, Charlson Comorbidity Index, and smoking to present marginal mean and associated 95% CIs. Results A total of 62.3% (1,611/2,586) of the cohort met the criteria for MetS. Both groups showed similar increase in mean OHS (MetS group 22.5 (95% CI 21.8 to 23.1), non-MetS group 22.1 (21.3 to 22.8); p = 0.477) and mean OKS (MetS group 18.0 (17.4 to 18.6), non-MetS group 17.8 (17.0 to 18.7); p = 0.722) at 12 months' follow-up. Between groups, similar improvements were seen for OHS and OKS at three and 24 months postoperatively and for the mean EQ-5D-5L, EuroQol-visual analogue scale (EQ-VAS), UCLA Activity Scale, and FJS at every timepoint. Conclusion Patients meeting the criteria for MetS obtain the same improvement in PROM scores as individuals without MetS up to 24 months after hip and knee arthroplasty. This is important for the clinician to take into account when assessing and advising patients with MetS.
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Affiliation(s)
- Rasmus R Sørensen
- Department of Orthopaedic Surgery, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark
| | - Signe Timm
- Department of Orthopaedic Surgery, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark
- Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
| | - Lasse E Rasmussen
- Department of Orthopaedic Surgery, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark
| | - Claus L Brasen
- Department of Immunology and Biochemistry, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark
| | - Claus Varnum
- Department of Orthopaedic Surgery, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark
- Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
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Rusconi D, Basile I, Rampichini F, Colombo S, Arba L, Pancheri ML, Consolo L, Lusignani M. Electronic Patient Reported Outcomes Measures (e-PROMs) in Pediatric Palliative Oncology Care: A Scoping Review. J Palliat Care 2024; 39:298-315. [PMID: 39295504 PMCID: PMC11504155 DOI: 10.1177/08258597241274027] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/21/2024]
Abstract
Objective: Research findings regarding child-centered care and electronic patient reported outcome measures (e-PROMs) within pediatric palliative oncology care reveal an intricate field of study. This study aimed to map innovations in e-PROMs for the pediatric cancer population in palliative care and their impact on symptom management, and communication with healthcare professionals. Methods: A scoping review was designed following the Arksey and O'Malley framework. Literature searches were conducted in CINAHL, Embase, MEDLINE, PsycINFO, SCOPUS, and Web of Science. Inclusion criteria targeted children aged 0-18 years with cancer, receiving palliative and/or end-of-life care, and using e-PROMs. Results: Twelve articles were included: 10 quantitative studies, one qualitative study, and one mixed-method study. A narrative synthesis approach was used to summarize the findings, categorized into three sections: (a) technological innovation of e-PROMs in pediatric palliative oncology care; (b) the impact of e-PROMs on symptom monitoring, management, and children's care; (c) the effects of e-PROMs on communication between children and healthcare professionals in pediatric palliative oncology care. Conclusion: e-PROMs have proven effective in empowering children to express their perspectives and actively engage in their end-of-life care. Due to flexible software and devices designed for various age groups, these tools fit seamlessly into children's daily routines and preferences, including the use of play-oriented applications. They facilitate a deeper understanding, and management of physical and emotional symptoms while ensuring care remains child-centered. This emphasizes the importance of preserving the essence of childhood and addressing the unique needs and experiences of young patients in pediatric palliative oncology care.
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Affiliation(s)
- Daniele Rusconi
- Urologic Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
| | - Ilaria Basile
- High-Complexity Unit of Palliative Care, Pain Therapy and Rehabilitation, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
| | - Flavia Rampichini
- Library of the Central School of Medicine, University of Milan, Milan, Italy
| | - Stella Colombo
- Intensive Care Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
| | - Laura Arba
- Head and Neck Cancer and Rare Tumor Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
| | - Maria Luisa Pancheri
- Bachelor School of Nursing, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan Italy
| | - Letteria Consolo
- Bachelor School of Nursing, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan Italy
| | - Maura Lusignani
- Department of Biomedical Sciences for Health, University of Milan, Milan, Italy
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11
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Boomstra E, Hommes S, Vromans RD, van der Burg S, Schrijver AM, Wouters MWJM, van der Ploeg IMC, van de Kamp MW, Krahmer EJ, van de Poll-Franse LV, de Ligt KM. "Numbers call for action, personalized narratives provide support and recognition": a qualitative assessment of cancer patients' perspectives on patient-reported outcome measures (PROMs) feedback with narratives. J Cancer Surviv 2024:10.1007/s11764-024-01663-7. [PMID: 39320669 DOI: 10.1007/s11764-024-01663-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2024] [Accepted: 08/13/2024] [Indexed: 09/26/2024]
Abstract
PURPOSE Patient-reported outcome measures (PROMs) are questionnaires completed by patients to gain insight in their health-related quality of life. However, patients often find the interpretation of PROMS challenging. A personalized narrative, i.e., a story with patients' experiences tailored to the reader, could help explain PROMs and might be appreciated alongside numerical outcomes. We studied how cancer patients perceive PROMs feedback presented in a regular numerical and a novel narrative format. METHODS Cancer patients who completed PROMs in routine clinical practice were recruited. All participants received numerical feedback and a personalized narrative. Semi-structured interviews were conducted to uncover perceptions of both formats. Interviews were analyzed with an inductive reflexive approach to thematic analysis. RESULTS Twenty-nine patients with breast cancer, melanoma, and bladder cancer participated. Thematic analysis identified six themes: "Understanding: I get the gist of it!"; "Usefulness: Tell me why I should complete PROMs"; "Format preferences: Numbers are cold, narratives are warm"; "Taking action: Can I do something about my score?"; "Personal relevance: Personalized narratives show me what life has in store for me"; and "Personal relevance: That's (not) me!" Numbers seemed to help participants act, whereas narratives may provide emotional support and recognition. Participants identified with the content of the narrative yet differed in how they related to the main character. CONCLUSION Personalized narratives could be a useful addition to PROMs feedback. The studied formats seem to serve different purposes; numbers help to facilitate action, personalized narratives provide recognition. IMPLICATIONS FOR CANCER SURVIVORS Personalized narratives may be a useful new way to communicate about quality of life to cancer survivors and help them to envision what the impact of cancer can be.
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Affiliation(s)
- E Boomstra
- Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands
| | - S Hommes
- Department of Communication and Cognition, Tilburg School of Humanities and Digital Sciences (TSHD), Tilburg University, Tilburg, The Netherlands
- Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands
| | - R D Vromans
- Department of Communication and Cognition, Tilburg School of Humanities and Digital Sciences (TSHD), Tilburg University, Tilburg, The Netherlands
| | - S van der Burg
- Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands
| | - A M Schrijver
- Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands
| | - M W J M Wouters
- Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands
- Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands
| | - I M C van der Ploeg
- Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands
| | - M W van de Kamp
- Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands
| | - E J Krahmer
- Department of Communication and Cognition, Tilburg School of Humanities and Digital Sciences (TSHD), Tilburg University, Tilburg, The Netherlands
| | - L V van de Poll-Franse
- Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands
- Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands
- Department of Medical and Clinical Psychology, Center of Research On Psychological and Somatic Disorders (CoRPS), Tilburg University, Tilburg, The Netherlands
| | - K M de Ligt
- Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
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12
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Patel V, Deshpande SV, Jadawala VH, Bhalsod D, Sawant S. Evaluating Short-Term Patient-Reported Outcome Measures Following Total Hip and Knee Replacement: A Comprehensive Review. Cureus 2024; 16:e70468. [PMID: 39479148 PMCID: PMC11522172 DOI: 10.7759/cureus.70468] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2024] [Accepted: 09/29/2024] [Indexed: 11/02/2024] Open
Abstract
Total hip replacement (THR) and total knee replacement (TKR) are widely performed surgical procedures to alleviate pain and improve function in patients with joint-related diseases. Short-term patient-reported outcome measures (PROMs) have become a key metric in assessing the success of these surgeries from the patient's perspective, focusing on early recovery, pain management, mobility, and quality of life. This comprehensive review evaluates the significance of short-term PROMs following THR and TKR, highlighting commonly used tools such as the Oxford Hip Score (OHS), Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and short-form health survey (SF-36). The analysis explores the impact of various factors, such as age, preoperative health status, and surgical technique, on short-term outcomes. Findings from recent studies indicate that while patients generally report improvements in physical function and pain relief within the first six months post-surgery, individual outcomes can vary significantly. Factors like early rehabilitation, mental health, and the presence of postoperative complications can influence the trajectory of recovery and satisfaction levels. Moreover, the review addresses the limitations of current PROMs, including variability in reporting and sensitivity to different patient populations. This review emphasizes the need for more personalized and standardized approaches to PROM assessment to better capture patient experiences and optimize postoperative care. Future research should focus on integrating PROMs with long-term follow-up data and digital health tools to track real-time patient progress, thus enhancing the overall quality of care for THR and TKR patients. Short-term PROMs play a vital role in understanding patient outcomes and guiding clinical practice for joint replacement surgeries.
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Affiliation(s)
- Vatsal Patel
- Orthopedics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Wardha, IND
| | - Sanjay V Deshpande
- Orthopedics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Wardha, IND
| | - Vivek H Jadawala
- Orthopedics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Wardha, IND
| | - Disheeta Bhalsod
- Anesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Wardha, IND
| | - Sharad Sawant
- Orthopedics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Wardha, IND
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13
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Cogliandro A, Mirra C, Gratteri M, Mannella V, Salzillo R, Bressi F, Miccinilli S, De Bernardis R, Savani L, Marangi GF, Persichetti P. LYMPH-Q translation, cultural adaptation and validation in Italian language: A prospective PROMs-based study on breast cancer-related arm lymphedema for patients' education. J Plast Reconstr Aesthet Surg 2024; 96:199-206. [PMID: 39096736 DOI: 10.1016/j.bjps.2024.07.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2024] [Revised: 06/18/2024] [Accepted: 07/08/2024] [Indexed: 08/05/2024]
Abstract
BACKGROUND Upper Extremity Lymphedema following oncological breast surgery affects not only the patient's physique, but also the patient's psychological sphere. One of the best known PROMs-based questionnaires for investigating the condition is the LYMPH-Q. The study aimed to perform the Italian translation and cultural adaptation of the LYMPH-Q and to assess if, independently from disease evolution, arm sleeve improves QoL in these patients. MATERIALS AND METHODS Translation included 4 steps: Forward translation, Back translation, Back translation review and Patient interviews. The questionnaire was administered to 50 female patients older than 18 years of age with UEL who received a prescription for daily use of a compression sheath. A second administration took place 30 days after. Forty-four patients completed the study (Group 1: 26 patients with indication to use compression sleeve who wore it; Group 2:18 patients who despite the prescription did not want to wear it. A descriptive statistical analysis was performed with Prism 9 software. RESULTS T-tests showed statistical significance for changes in "Symptoms," "Function," "Appearance" and "Psychological" scales. There were no statistically significant changes for "Information scale" in Group 1 and for all scales in Group 2. CONCLUSION Data from this observational study show that HR-QOL analyzed from the patients' perspective also tends to improve in terms of symptoms, function, appearance, and psychological sphere in patients with BCRL when using a compression sheath. The Lymph-Q has proven to be a valuable ally of the physician attempting to improve treatment approaches for BCRL based not only on scientific evidence but also on PROMs.
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Affiliation(s)
- Annalisa Cogliandro
- Department of Plastic, Reconstructive and Cosmetic Surgery, Rome Biomedical Campus Foundation, Via Alvaro del Portillo 200, Rome, Italy
| | - Carlo Mirra
- Department of Plastic, Reconstructive and Cosmetic Surgery, Rome Biomedical Campus Foundation, Via Alvaro del Portillo 200, Rome, Italy
| | - Marco Gratteri
- Department of Plastic, Reconstructive and Cosmetic Surgery, Rome Biomedical Campus Foundation, Via Alvaro del Portillo 200, Rome, Italy.
| | | | - Rosa Salzillo
- Department of Plastic, Reconstructive and Cosmetic Surgery, Rome Biomedical Campus Foundation, Via Alvaro del Portillo 200, Rome, Italy
| | - Federica Bressi
- Physical and Rehabilitative Medicine Department, Rome Biomedical Campus Foundation, Via Alvaro del Portillo 200, Rome, Italy
| | - Sandra Miccinilli
- Physical and Rehabilitative Medicine Department, Rome Biomedical Campus Foundation, Via Alvaro del Portillo 200, Rome, Italy
| | - Riccardo De Bernardis
- Department of Plastic, Reconstructive and Cosmetic Surgery, Rome Biomedical Campus Foundation, Via Alvaro del Portillo 200, Rome, Italy
| | - Luca Savani
- Department of Plastic, Reconstructive and Cosmetic Surgery, Rome Biomedical Campus Foundation, Via Alvaro del Portillo 200, Rome, Italy
| | - Giovanni Francesco Marangi
- Department of Plastic, Reconstructive and Cosmetic Surgery, Rome Biomedical Campus Foundation, Via Alvaro del Portillo 200, Rome, Italy
| | - Paolo Persichetti
- Department of Plastic, Reconstructive and Cosmetic Surgery, Rome Biomedical Campus Foundation, Via Alvaro del Portillo 200, Rome, Italy
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Nikkhah J, Steinbeck V, Grobe TG, Breitkreuz T, Pross C, Busse R. Evaluating the Population-Based Usage and Benefit of Digitally Collected Patient-Reported Outcomes and Experiences in Patients With Chronic Diseases: The PROMchronic Study Protocol. JMIR Res Protoc 2024; 13:e56487. [PMID: 39102279 PMCID: PMC11333866 DOI: 10.2196/56487] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2024] [Revised: 03/28/2024] [Accepted: 04/24/2024] [Indexed: 08/06/2024] Open
Abstract
BACKGROUND Chronic diseases are associated with a high disease burden. Under- and overprovision of care as well as quality variation between health care providers persists, while current quality indicators rarely capture the patients' perspective. Capturing patient-reported outcome measures (PROMs) as well as patient-reported experience measures (PREMs) is becoming more and more important to identify gaps in care provision, prioritize services most valuable to patients, and aid patients' self-management. OBJECTIVE This study aims to measure the potential benefits and effectiveness of using electronic patient-reported outcome measures (ePROMs) and electronic patient-reported experience measures in a structured and population-based manner to enhance health care for chronic disease patients in Germany. METHODS This prospective cohort study aims to evaluate the potential benefits of PROM usage in patients with chronic diseases. We evaluate whether (1) digitally collected PROMs and PREMs can be used for health system performance assessment by generating a representative response of chronically diseased individuals with asthma, chronic obstructive pulmonary disease, diabetes, and coronary artery disease across Germany, and (2) based on the PROMs and PREMs, low-value care can be identified. As patient-reported outcomes (PROs) are rarely presented back to patients, (3) this study also examines patients' reactions to their PROM scores in the form of digital PRO feedback. For these purposes, randomly selected patients from a nationwide German insurer are digitally surveyed with generic and disease-specific PROMs and PREMs, as well as additional questions on their health-related behavior, 4 times over 1 year. Individual PRO feedback is presented back to patients longitudinally and compared to a peer group after each survey period. Patient-reported data is linked with health insurance data. Response rates, changes in health and experience outcomes over time, self-reported changes in health behavior, and health care system usage will be analyzed. RESULTS The PROMchronic study explores the usage of PROMs in patients with chronic diseases. Data collection began in October 2023, after the initial invitation letter. All the 200,000 potential patients have been invited to participate in the study. Data have not yet been analyzed. Publication of the interim results is planned for the autumn of 2024, and the results are planned to be published in 2025. CONCLUSIONS We aim to fill the research gap on the population-based usage of PROMs and PREMs in patients with chronic diseases and add to the current understanding of PROM data-sharing with patients. The study's results can thereby inform whether a health care system-wide approach to collecting PROMs and PREMs can be used to identify low-value care, assess quality variation within and across chronic conditions, and determine whether PRO feedback is helpful and associated with any changes in patients' health behaviors. TRIAL REGISTRATION German Clinical Trials Register DRKS00031656; https://drks.de/search/en/trial/DRKS00031656. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/56487.
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Affiliation(s)
- Janis Nikkhah
- Department of Healthcare Management, School of Economics and Management, Technical University Berlin, Berlin, Germany
| | - Viktoria Steinbeck
- Department of Healthcare Management, School of Economics and Management, Technical University Berlin, Berlin, Germany
| | | | | | - Christoph Pross
- Department of Healthcare Management, School of Economics and Management, Technical University Berlin, Berlin, Germany
| | - Reinhard Busse
- Department of Healthcare Management, School of Economics and Management, Technical University Berlin, Berlin, Germany
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15
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Lormans T, de Graaf E, de Vries S, Leget C, Teunissen S. 'It is important to feel invited': what patients require when using the Utrecht Symptom Diary - 4 Dimensional, a qualitative exploration. Palliat Care Soc Pract 2024; 18:26323524241260426. [PMID: 38911602 PMCID: PMC11191620 DOI: 10.1177/26323524241260426] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2023] [Accepted: 05/22/2024] [Indexed: 06/25/2024] Open
Abstract
Background In palliative care, the Utrecht Symptom Diary - 4 Dimensional (USD-4D), a Dutch-adapted and validated patient-reported outcome measure, supports multidimensional symptom management through identification and monitoring of, as well as dialogue on symptoms and needs. For the USD-4D to optimally support patients' autonomy, it is essential to know what patients need to use it. Objective This study aims to identify what patients need when using the USD-4D in clinical palliative care. Design A generic qualitative design with primary and secondary analyses of semistructured interviews. Methods Patients ⩾18 years with a life-limiting illness were purposefully recruited within hospice and home care settings if they were in their last year of life as identified by the surprise question. Patients had to be aware of their life-threatening condition. Patients were selected in two tranches. In the first tranche, patients had to have completed the USD-4D at least once. The second tranche consisted of patients who were not familiar with the USD-4D in clinical practice and were interviewed in a previous study on the content validity of the USD-4D. The interviews were transcribed verbatim and were subjected to thematic analysis. Results Twenty-five patients were included (14 men, ages 44-87). Patients' needs when using the USD-4D were summarized in three themes: (1) feeling invited, (2) being aware of the purpose and function of the USD-4D, and (3) experiencing a personal and nonjudgmental approach. Conclusion For patients to optimally benefit from the USD-4D as a supportive measure of their autonomy in clinical palliative care, it is essential that they feel invited to use it. Healthcare providers are tasked with setting the right preconditions for patients to want and to be able to use the USD-4D. For patients, this means healthcare providers should always be attuned to their personal preferences when communicating the purpose and function of the USD-4D and when they enter into dialogue with them.
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Affiliation(s)
- Tom Lormans
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, Utrecht 3584CG, The Netherlands
| | - Everlien de Graaf
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
| | - Sita de Vries
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
| | - Carlo Leget
- Care Ethics, University of Humanistic Studies, Utrecht, The Netherlands
| | - Saskia Teunissen
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
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16
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van Hoorn ES, Willems SP, Al Arashi W, de Moor AS, van Kwawegen CB, Teela L, Oude Voshaar MA, Kremer Hovinga IC, Schutgens RE, Schols SE, Leebeek FW, Haverman L, Cnossen MH, Gouw SC, Lingsma HF. Psychometrics of patient-reported outcomes measurement information system in von Willebrand disease, inherited platelet function disorders, and rare bleeding disorders. Res Pract Thromb Haemost 2024; 8:102474. [PMID: 39076727 PMCID: PMC11284954 DOI: 10.1016/j.rpth.2024.102474] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/01/2024] [Revised: 06/05/2024] [Accepted: 06/07/2024] [Indexed: 07/31/2024] Open
Abstract
Background Patient-reported outcomes measurement information system (PROMIS) measures can be used to measure patient-reported outcomes. PROMIS measures, including computer adaptive tests (CATs) and short forms, have demonstrated the ability to adequately assess outcomes in patients with hemophilia. It is, however, unclear if PROMIS measures are suitable for patients with von Willebrand disease (VWD), inherited platelet function disorders (IPFDs), and rare bleeding disorders (RBDs). Objectives To evaluate the feasibility, measurement properties, and relevance of PROMIS measures in adults with VWD, IPFDs, and RBDs. Methods In this cross-sectional multicenter study, adults with VWD, IPFDs, and RBDs completed 9 PROMIS measures and the Short Form-36 version 2 (SF-36v2) electronically. Feasibility was determined by the number of completed items and floor/ceiling effects. Measurement properties included construct validity based on a multitrait-multimethod analysis and reliability using the reliability coefficient and greatest lower bound. Relevance was evaluated based on comparison with the Dutch general population. Results In total, 111 patients (median age, 57 years [IQR, 44-67]; 60% VWD, 16% IPFD, 24% RBD) participated. Mean number of items answered varied from 5.3 to 8.7 (range, 4-12) per PROMIS CAT in patients with VWD. Construct validity was supported for all CATs and all instruments had a good reliability (≥0.70). The PROMIS measures had less ceiling effects than the SF-36v2. Conclusion The PROMIS measures are a feasible, valid, and reliable alternative for the SF-36v2 in patients with primarily nonsevere forms of VWD. The relevance of the selected measures was limited. Additional research is necessary to evaluate the PROMIS measures in adults with IPFDs and RBDs.
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Affiliation(s)
- Evelien S. van Hoorn
- Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
| | - Sterre P.E. Willems
- Department of Hematology, Radboud university medical center Nijmegen, Hemophilia Treatment Center Nijmegen-Eindhoven-Maastricht, Nijmegen, The Netherlands
| | - Wala Al Arashi
- Department of Pediatric Hematology, Erasmus MC Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands
| | - Annick S. de Moor
- Center for Benign Hematology, Thrombosis and Hemostasis, Van Creveldkliniek University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
| | - Calvin B. van Kwawegen
- Department of Hematology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
| | - Lorynn Teela
- Child and Adolescent Psychiatry & Psychosocial Care, Emma Children’s Hospital, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
- Public Health, Mental Health and Digital Health, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
- Reproduction and Development, Child Development, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
| | - Martijn A.H. Oude Voshaar
- Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
| | - Idske C.L. Kremer Hovinga
- Center for Benign Hematology, Thrombosis and Hemostasis, Van Creveldkliniek University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
| | - Roger E.G. Schutgens
- Center for Benign Hematology, Thrombosis and Hemostasis, Van Creveldkliniek University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
| | - Saskia E.M. Schols
- Department of Hematology, Radboud university medical center Nijmegen, Hemophilia Treatment Center Nijmegen-Eindhoven-Maastricht, Nijmegen, The Netherlands
| | - Frank W.G. Leebeek
- Department of Hematology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
| | - Lotte Haverman
- Child and Adolescent Psychiatry & Psychosocial Care, Emma Children’s Hospital, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
- Public Health, Mental Health and Digital Health, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
- Reproduction and Development, Child Development, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
| | - Marjon H. Cnossen
- Department of Pediatric Hematology, Erasmus MC Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands
| | - Samantha C. Gouw
- Pediatric Hematology, Emma Children’s Hospital, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
| | - Hester F. Lingsma
- Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
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Silva LA, Silva KR, Saucedo SCM, Costa R. Predictors of Quality of Life, Anxiety and Acceptance in Patients with Implantable Cardioverter-Defibrillator. Arq Bras Cardiol 2024; 121:e20230590. [PMID: 38695410 PMCID: PMC11098579 DOI: 10.36660/abc.20230590] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/18/2023] [Revised: 11/16/2023] [Accepted: 01/18/2024] [Indexed: 05/18/2024] Open
Abstract
BACKGROUND An implantable cardioverter-defibrillator (ICD) can cause high levels of anxiety and depression, resulting in negative effects on quality of life. OBJECTIVES To evaluate the quality of life, anxiety, and acceptance of the ICD using standardized measurement instruments and identify predictors of better responses for each of the outcomes studied. METHOD This is a prospective cohort study with patients undergoing initial ICD implantation or reoperation to maintain the device. The study outcomes included quality of life, anxiety, and acceptance of the ICD. The change in scores (30 and 180 days) was assessed using the minimal important difference (MID). Univariate analysis and the multivariate logistic regression model were used to identify predictors of better responses, adopting a significance level of 5%. RESULTS A total of 147 patients were included between January/2020 to June/2021, with a mean age of 55.3 ± 13.4 years and a predominance of males (72.1%). The MID for quality of life, anxiety, and ICD acceptance were observed in 33 (22.4%), 36 (24.5%) and 43 (29.3%) patients, respectively. Age equal to or greater than 60 years (OR=2.5; 95%CI=1.14-5.53; p=0.022), absence of atrial fibrillation (OR=3.8; 95%CI=1.26-11.63; p=0.017) and female gender (OR=2.2; 95%CI=1.02-4.97; p=0.045) were independent predictors of better responses to quality of life, anxiety and acceptance of the ICD, respectively. CONCLUSION The identification of predictors for better quality of life scores, anxiety, and acceptance of the device can support the implementation of specific care for patients with a greater chance of presenting unfavorable results.
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Affiliation(s)
- Laisa Arruda Silva
- Hospital das ClínicasFaculdade de MedicinaUniversidade de São PauloSão PauloSPBrasilInstituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP – Brasil
| | - Katia Regina Silva
- Hospital das ClínicasFaculdade de MedicinaUniversidade de São PauloSão PauloSPBrasilInstituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP – Brasil
| | - Sarah Caroline Martins Saucedo
- Hospital das ClínicasFaculdade de MedicinaUniversidade de São PauloSão PauloSPBrasilInstituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP – Brasil
| | - Roberto Costa
- Hospital das ClínicasFaculdade de MedicinaUniversidade de São PauloSão PauloSPBrasilInstituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP – Brasil
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Gratteri M, Marangi GF, Mirra C, Arcari L, Romano FD, Cimmino A, Cogliandro A, Cagli B, Segreto F, Persichetti P. Impact of Incisional Access Site in Primary Breast Augmentation: Evaluation of Patient Satisfaction with SCAR-Q. Aesthetic Plast Surg 2024; 48:1565-1570. [PMID: 37495729 DOI: 10.1007/s00266-023-03502-z] [Citation(s) in RCA: 3] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/17/2023] [Accepted: 06/30/2023] [Indexed: 07/28/2023]
Abstract
BACKGROUND Scarring at the incision site represents one of the most impactful outcomes in breast augmentation surgery for both the patient and the surgeon. Few studies exist with the aim of assessing patient perception of scarring outcomes in primary breast augmentation. The aim of this study was to evaluate the impact on quality of life of scars by submitting the SCAR-Q in patients who underwent primary augmentation mammoplasty. METHODS The SCAR-Q was administered at one and at 6 months after surgery to 54 consecutive patients underwent primary breast augmentation with inferior hemi-periareolar or inframammary incision. A total of 50 patients were divided into two groups of 21 patients with inferior hemi-periareolar incision and 29 patients with inframammary fold incision, respectively. Statistical analysis was performed with Prism 9. RESULTS All mean values of the three SCAR-Q scales tend to decrease at the second administration meaning that the perception of the scar is better at time 6 from the patient perspective. In the "Psychosocial scale," lower values at both 1 month and 6 months for group 2 compared to group 1 were shown. Unpaired T tests with Welch's correction showed significance for delta values variations between the two groups with P values <0.0001. CONCLUSION Data show that patients undergoing primary breast augmentation have a scar that has no significant impact. Patients with inframammary fold scar have less psychosocial impact than those with inferior hemi-periareolar scar. There were no statistically significant differences in scar-related symptoms and scar appearance between scar along the inframammary groove and inferior hemi-periareolar scar. LEVEL OF EVIDENCE IV Case series study. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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Affiliation(s)
- Marco Gratteri
- Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Bio-Medico University Hospital, Via Alvaro del Portillo 200, Rome, Italy
| | - Giovanni Francesco Marangi
- Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Bio-Medico University Hospital, Via Alvaro del Portillo 200, Rome, Italy
| | - Carlo Mirra
- Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Bio-Medico University Hospital, Via Alvaro del Portillo 200, Rome, Italy.
| | - Lucrezia Arcari
- Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Bio-Medico University Hospital, Via Alvaro del Portillo 200, Rome, Italy
| | - Fara Desiree Romano
- Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Bio-Medico University Hospital, Via Alvaro del Portillo 200, Rome, Italy
| | - Andrea Cimmino
- Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Bio-Medico University Hospital, Via Alvaro del Portillo 200, Rome, Italy
| | - Annalisa Cogliandro
- Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Bio-Medico University Hospital, Via Alvaro del Portillo 200, Rome, Italy
| | - Barbara Cagli
- Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Bio-Medico University Hospital, Via Alvaro del Portillo 200, Rome, Italy
| | - Francesco Segreto
- Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Bio-Medico University Hospital, Via Alvaro del Portillo 200, Rome, Italy
| | - Paolo Persichetti
- Department of Plastic, Reconstructive and Cosmetic Surgery, Campus Bio-Medico University Hospital, Via Alvaro del Portillo 200, Rome, Italy
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19
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Corbett RW, Beckwith H, Lucisano G, Brown EA. Delivering Person-Centered Peritoneal Dialysis. Clin J Am Soc Nephrol 2024; 19:377-384. [PMID: 37611155 PMCID: PMC10937028 DOI: 10.2215/cjn.0000000000000281] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2023] [Accepted: 08/03/2023] [Indexed: 08/25/2023]
Abstract
Peritoneal dialysis (PD) enables people to have a home-based therapy, permitting greater autonomy for individuals along with enhanced treatment satisfaction compared with in-center dialysis care. The burden of treatment on PD, however, remains considerable and underpins the need for person-centered care. This reflects the need to address the patient as a person with needs and preferences beyond just the medical perspective. Shared decision making is central to the recent International Society for Peritoneal Dialysis recommendations for prescribing PD, balancing the potential benefits of PD on patient well-being with the burden associated with treatment. This review considers the role of high-quality goal-directed prescribing, incremental dialysis, and remote patient monitoring in reducing the burden of dialysis, including an approach to implementing incremental PD. Although patient-related outcomes are important in assessing the response to treatment and, particularly life participation, the corollary of dialysis burden, there are no clear routes to the clinical implementation of patient-related outcome measures. Delivering person-centered care is dependent on treating people both as individuals and as equal partners in their care.
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Affiliation(s)
- Richard W. Corbett
- Renal and Transplant Centre, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom
| | - Hannah Beckwith
- MRC London Institute of Medical Sciences (LMS), Imperial College London, London, United Kingdom
| | - Gaetano Lucisano
- Renal and Transplant Centre, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom
| | - Edwina A. Brown
- Renal and Transplant Centre, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom
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20
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Costantino RC, Gressler LE, Highland KB, Oehrlein EM, Villalonga-Olives E, Perfetto EM. Patient-centeredness and psychometric properties of the Defense and Veterans Pain Rating Scale 2.0 (DVPRS). PAIN MEDICINE (MALDEN, MASS.) 2024; 25:57-62. [PMID: 37699011 DOI: 10.1093/pm/pnad125] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/30/2023] [Revised: 07/24/2023] [Accepted: 08/31/2023] [Indexed: 09/14/2023]
Abstract
OBJECTIVE This study aims to assess the patient-centeredness and psychometric properties of the Defense and Veterans Pain Rating Scale 2.0 (DVPRS) as a patient-reported outcome measure (PROM) for pain assessment in a military population. DESIGN A critical evaluation of the DVPRS was conducted, considering its fit-for-purpose as a PROM and its patient-centeredness using the National Health Council's Rubric to Capture the Patient Voice. SETTING The study focused on the use of the DVPRS within the Department of Defense (DoD) and Veterans Health Administration (VA) healthcare settings. SUBJECTS The DVPRS was evaluated based on published studies and information provided by measure developers. The assessment included content validity, reliability, construct validity, and ability to detect change. Patient-centeredness and patient engagement were assessed across multiple domains. METHODS Two independent reviewers assessed the DVPRS using a tool/checklist/questionnaire, and any rating discrepancies were resolved through consensus. The assessment included an evaluation of psychometric properties and patient-centeredness based on established criteria. RESULTS The DVPRS lacked sufficient evidence of content validity, with no patient involvement in its development. Construct validity was not assessed adequately, and confirmatory factor analysis was not performed. Patient-centeredness and patient engagement were also limited, with only a few domains showing meaningful evidence of patient partnership. CONCLUSIONS The DVPRS as a PROM for pain assessment in the military population falls short in terms of content validity, construct validity, and patient-centeredness. It requires further development and validation, including meaningful patient engagement, to meet current standards and best practices for PROMs.
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Affiliation(s)
- Ryan C Costantino
- Enterprise Intelligence and Data Solutions Program Management Office, Program Executive Office, Defense Healthcare Management Systems, Rosslyn, VA 22209, United States
- Department of Practice, Sciences, and Health Outcomes Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, United States
| | - Laura E Gressler
- Division of Pharmaceutical Evaluation and Policy, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, AR 72205, United States
| | - Krista B Highland
- Department of Military and Emergency Medicine, Uniformed Services University, Bethesda, MD 20814, United States
- Department of Anesthesiology, Uniformed Services University, Bethesda, MD 20814, United States
- Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD 20817, United States
| | | | - Ester Villalonga-Olives
- Department of Practice, Sciences, and Health Outcomes Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, United States
| | - Eleanor M Perfetto
- Department of Practice, Sciences, and Health Outcomes Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, United States
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21
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Liang M, Ye Z. Patient-reported outcome measures in cancer care: Integration with computerized adaptive testing. Asia Pac J Oncol Nurs 2023; 10:100323. [PMID: 38033390 PMCID: PMC10686812 DOI: 10.1016/j.apjon.2023.100323] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/21/2023] [Accepted: 10/19/2023] [Indexed: 12/02/2023] Open
Affiliation(s)
- Minyu Liang
- School of Nursing, Guangzhou University of Chinese Medicine, Guangzhou, China
| | - Zengjie Ye
- School of Nursing, Guangzhou Medical University, Guangzhou, China
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22
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Soares Ferreira Junior A, Pinheiro Maux Lessa M, Kaplan S, Coles TM, Terrell DR, Onwuemene OA. Patient-Reported Outcome Measures in Patients with Thrombotic Thrombocytopenic Purpura: A Systematic Review of the Literature. J Clin Med 2023; 12:5155. [PMID: 37568558 PMCID: PMC10420299 DOI: 10.3390/jcm12155155] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/14/2023] [Revised: 07/31/2023] [Accepted: 08/01/2023] [Indexed: 08/13/2023] Open
Abstract
Health-related quality of life (HRQoL) impacts of thrombotic thrombocytopenic purpura (TTP) have been captured in clinical studies using patient-reported outcome (PRO) measures (PROMs) that are validated for other diseases. However, the validity evidence to support the use of existing PROMs in patients with TTP is unknown. In a systematic review of the literature, including studies of adults and children with TTP, we assessed the validity evidence for use of PROMs in clinical research and clinical practice, characterized HRQoL, described the integration of PROMs in clinical practice and evaluated PRO scores for patients with TTP compared with reference populations. From an initial 4518 studies, we identified 14 studies using 16 PROMs to assess general HRQoL domains in patients in remission. No identified studies assessed the validity of PROMs for the context of use of TTP and no studies described PROM integration into TTP clinical practice or evaluated PROMs that were specific for patients with TTP. Moreover, PRO scores were worse in patients with TTP compared with reference populations and other chronic conditions. We conclude that, in patients with TTP, PROMs pick up on important patient experiences not captured by clinical outcomes at present. There is, therefore, a need for studies that assess the validity of existing PROMs in patients with TTP to determine if TTP-specific PROMs specific to patients with TTP should be developed.
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Affiliation(s)
| | - Morgana Pinheiro Maux Lessa
- Department of Medicine, Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto 15090-000, São Paulo, Brazil
| | - Samantha Kaplan
- Medical Center Library & Archives, Duke University Medical Center, Durham, NC 27710, USA;
| | - Theresa M. Coles
- Department of Population Health Sciences, Duke University School of Medicine, Durham, NC 27710, USA;
| | - Deirdra R. Terrell
- Department of Biostatistics and Epidemiology, Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA;
| | - Oluwatoyosi A. Onwuemene
- Division of Hematology, Department of Medicine, Duke University School of Medicine, Durham, NC 27710, USA
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23
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Consolo L, Colombo S, Basile I, Rusconi D, Campa T, Caraceni A, Lusignani M. Barriers and facilitators of electronic patient-reported outcome measures (e-PROMs) for patients in home palliative cancer care: a qualitative study of healthcare professionals' perceptions. BMC Palliat Care 2023; 22:111. [PMID: 37542264 PMCID: PMC10401773 DOI: 10.1186/s12904-023-01234-0] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/27/2023] [Accepted: 07/26/2023] [Indexed: 08/06/2023] Open
Abstract
BACKGROUND Patient-reported outcomes in palliative care enable early monitoring and management of symptoms that most impact patients' daily lives; however, there are several barriers to adopting electronic Patient-reported Outcome Measures (e-PROMs) in daily practice. This study explored the experiences of health care professionals (HCPs) regarding potential barriers and facilitators in implementing e-PROMs in palliative cancer care at home. METHODS This was a qualitative descriptive study. The data were collected from two focus groups structured according to the conceptual framework of Grol. HCPs involved in home palliative cancer care of Fondazione IRCCS Istituto Nazionale dei Tumori of Milan were enrolled. Data were analyzed using a reflexive thematic analysis. RESULTS A total of 245 codes were generated, 171 for the first focus group and 74 for the second focus group. The results were subdivided into subthemes according to Grol's themes: Innovation, Individual professional, Patient, Social context, Organizational context, except Economic Political context. Nine HCPs attended the first focus group, and ten attended the second. According to these participants, e-PROMs could be integrated into clinical practice after adequate training and support of HCPs at all stages of implementation. They identified barriers, especially in the social and organizational contexts, due to the uniqueness of the oncological end-of-life setting and the intangible care interventions, as well as many facilitators for the innovation that these tools bring and for improved communication with the patient and the healthcare team. CONCLUSIONS e-PROMs are perceived by HCPs as adding value to patient care and their work; however, barriers remain especially related to the fragility of these patients, the adequacy of technological systems, lack of education, and the risk of low humanization of care.
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Affiliation(s)
- Letteria Consolo
- Department of Biomedicine and Prevention, University of Rome "Tor Vergata", Rome, Italy.
- Bachelor School of Nursing, IRCCS, National Cancer Institute, Milan, Italy.
| | - Stella Colombo
- Intensive Care Unit, IRCCS, National Cancer Institute, Milan, Italy
| | - Ilaria Basile
- High-Complexity Unit of Palliative Care, Pain Therapy and Rehabilitation, IRCCS, National Cancer Institute, Milan, Italy
| | - Daniele Rusconi
- Urology Unit, IRCCS, National Cancer Institute, Milan, Italy
| | - Tiziana Campa
- High-Complexity Unit of Palliative Care, Pain Therapy and Rehabilitation, IRCCS, National Cancer Institute, Milan, Italy
| | - Augusto Caraceni
- High-Complexity Unit of Palliative Care, Pain Therapy and Rehabilitation, IRCCS, National Cancer Institute, Milan, Italy
- University of Milan, Milan, Italy
| | - Maura Lusignani
- Department of Biomedical Sciences for Health, University of Milan, Milan, Italy
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24
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Vargo MM. Outcome Measures and Patient-Reported Metrics in Cancer Rehabilitation. Curr Oncol Rep 2023; 25:869-882. [PMID: 37148415 DOI: 10.1007/s11912-023-01412-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/20/2023] [Indexed: 05/08/2023]
Abstract
PURPOSE OF REVIEW The current panorama of measurement tools for use in cancer rehabilitation is reviewed. For rehabilitation purposes, evaluating function is of the highest priority. RECENT FINDINGS From a patient-reported outcome (PRO) standpoint, SF-36 and EORTC-QLQ-C30 are in most common use in cancer rehabilitation research; these are quality of life measures that contain functional subdomains. Newer tools which are based on item response theory and have options for both computer assisted or short form (SF) administration, including the Patient-Reported Outcomes Measurement Information System (PROMIS) and Activity Measure for Post-acute Care (AMPAC) instruments, show increasing use, especially PROMIS Physical Function SF, and, recently, PROMIS Cancer Function Brief 3D, which has been validated in the cancer population, with domains of physical function, fatigue, and social participation, to track clinical rehabilitation outcomes. Evaluating objective measures of function in cancer patients is also crucial. Utilization of clinically feasible tools for cancer rehabilitation, to employ for both screening purposes and for monitoring of rehabilitation treatment efficacy, is an evolving area, much needed to promote further research and improved, consistent clinical care for cancer patients and survivors.
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Affiliation(s)
- Mary M Vargo
- Physical Medicine and Rehabilitation, MetroHealth Medical Center, Case Western Reserve University, 4229 Pearl Road, Cleveland, OH, 44109, USA.
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25
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Mendoza-Quispe D, Perez-Leon S, Alarcon-Ruiz CA, Gaspar A, Cuba-Fuentes MS, Zunt JR, Montori VM, Bazo-Alvarez JC, Miranda JJ. Scoping review of measures of treatment burden in patients with multimorbidity: advancements and current gaps. J Clin Epidemiol 2023; 159:92-105. [PMID: 37217106 PMCID: PMC10529536 DOI: 10.1016/j.jclinepi.2023.05.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/26/2022] [Revised: 05/03/2023] [Accepted: 05/16/2023] [Indexed: 05/24/2023]
Abstract
OBJECTIVES To identify, assess, and summarize the measures to assess burden of treatment in patients with multimorbidity (BoT-MMs) and their measurement properties. STUDY DESIGN AND SETTING MEDLINE via PubMed was searched from inception until May 2021. Independent reviewers extracted data from studies in which BoT-MMs were developed, validated, or reported as used, including an assessment of their measurement properties (e.g., validity and reliability) using the COnsensus-based Standards for the selection of health Measurement INstruments. RESULTS Eight BoT-MMs were identified across 72 studies. Most studies were performed in English (68%), in high-income countries (90%), without noting urban-rural settings (90%). No BoT-MMs had both sufficient content validity and internal consistency; some measurement properties were either insufficient or uncertain (e.g., responsiveness). Other frequent limitations of BoT-MMs included absent recall time, presence of floor effects, and unclear rationale for categorizing and interpreting raw scores. CONCLUSION The evidence needed for use of extant BoT-MMs in patients with multimorbidity remains insufficiently developed, including that of suitability for their development, measurement properties, interpretability of scores, and use in low-resource settings. This review summarizes this evidence and identifies issues needing attention for using BoT-MMs in research and clinical practice.
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Affiliation(s)
- Daniel Mendoza-Quispe
- CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.
| | - Silvana Perez-Leon
- CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru
| | - Christoper A Alarcon-Ruiz
- Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud, Universidad San Ignacio de Loyola, Lima, Peru
| | - Andrea Gaspar
- School of Medicine, University of Washington, Washington, DC, USA
| | | | - Joseph R Zunt
- Departments of Neurology, Global Health, Medicine (Infectious Diseases), and Epidemiology, University of Washington, Seattle, WA, USA
| | - Victor M Montori
- Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN 55905, USA
| | - Juan Carlos Bazo-Alvarez
- Research Department of Primary Care and Population Health, University College London, London, UK
| | - J Jaime Miranda
- CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru; School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; The George Institute for Global Health, UNSW, Sydney, Australia
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26
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Kim M, Fong J, Pusic AL, Fischer JP, Mehrara BJ, Nelson JA. Editorial: Maintaining the Integrity of PROMs in Research and Practice. Ann Surg Oncol 2023; 30:3879-3881. [PMID: 37038036 DOI: 10.1245/s10434-023-13394-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/31/2023] [Accepted: 03/13/2023] [Indexed: 04/12/2023]
Affiliation(s)
- Minji Kim
- Plastic and Reconstructive Surgery Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Joline Fong
- Plastic and Reconstructive Surgery Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Andrea L Pusic
- Division of Plastic and Reconstructive Surgery, Department of Surgery, Brigham Health, Boston, MA, USA
| | - John P Fischer
- Division of Plastic Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA
| | - Babak J Mehrara
- Plastic and Reconstructive Surgery Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Jonas A Nelson
- Plastic and Reconstructive Surgery Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
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Hyland CJ, Pusic AL, Liu JB. Patient-Reported Outcomes and Surgical Quality. Clin Colon Rectal Surg 2023; 36:259-264. [PMID: 37223232 PMCID: PMC10202543 DOI: 10.1055/s-0043-1761594] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/25/2023]
Abstract
Delivering high-quality surgical care requires knowing how best to define and measure quality in surgery. Patient-reported outcomes (PROs) enable surgeons, health care systems, and payers to understand meaningful health outcomes from the patient's perspective and can be measured using patient-reported outcome measures (PROMs). As a result, there is much interest in using PROMs in routine surgical care, to guide quality improvement and to inform reimbursement pay structures. This chapter defines PROs and PROMs, differentiates PROMs from other quality measures such as patient-reported experience measures, describes PROMs in the context of routine clinical care, and provides an overview of interpreting PROM data. This chapter also describes how PROMs may be applied to quality improvement and value-based reimbursement in surgery.
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Affiliation(s)
- Colby J. Hyland
- Division of Plastic and Reconstructive Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
- Patient-Reported Outcomes, Value, and Experience (PROVE) Center, Brigham and Women's Hospital, Boston, Massachusetts
| | - Andrea L. Pusic
- Division of Plastic and Reconstructive Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
- Patient-Reported Outcomes, Value, and Experience (PROVE) Center, Brigham and Women's Hospital, Boston, Massachusetts
| | - Jason B. Liu
- Patient-Reported Outcomes, Value, and Experience (PROVE) Center, Brigham and Women's Hospital, Boston, Massachusetts
- Section of Endocrine Surgery, Division of Surgical Oncology, Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts
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Papachristou N, Kartsidis P, Anagnostopoulou A, Marshall-McKenna R, Kotronoulas G, Collantes G, Valdivieso B, Santaballa A, Conde-Moreno AJ, Domenech JR, Kokoroskos E, Papachristou P, Sountoulides P, Levva S, Avgitidou K, Tychala C, Bakogiannis C, Stafylas P, Ramon ZV, Serrano A, Tavares V, Fernandez-Luque L, Hors-Fraile S, Billis A, Bamidis PD. A Smart Digital Health Platform to Enable Monitoring of Quality of Life and Frailty in Older Patients with Cancer: A Mixed-Methods, Feasibility Study Protocol. Semin Oncol Nurs 2023; 39:151437. [PMID: 37149438 DOI: 10.1016/j.soncn.2023.151437] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2023] [Accepted: 03/29/2023] [Indexed: 05/08/2023]
Abstract
OBJECTIVES LifeChamps is an EU Horizon 2020 project that aims to create a digital platform to enable monitoring of health-related quality of life and frailty in patients with cancer over the age of 65. Our primary objective is to assess feasibility, usability, acceptability, fidelity, adherence, and safety parameters when implementing LifeChamps in routine cancer care. Secondary objectives involve evaluating preliminary signals of efficacy and cost-effectiveness indicators. DATA SOURCES This will be a mixed-methods exploratory project, involving four study sites in Greece, Spain, Sweden, and the United Kingdom. The quantitative component of LifeChamps (single-group, pre-post feasibility study) will integrate digital technologies, home-based motion sensors, self-administered questionnaires, and the electronic health record to (1) enable multimodal, real-world data collection, (2) provide patients with a coaching mobile app interface, and (3) equip healthcare professionals with an interactive, patient-monitoring dashboard. The qualitative component will determine end-user usability and acceptability via end-of-study surveys and interviews. CONCLUSION The first patient was enrolled in the study in January 2023. Recruitment will be ongoing until the project finishes before the end of 2023. IMPLICATIONS FOR NURSING PRACTICE LifeChamps provides a comprehensive digital health platform to enable continuous monitoring of frailty indicators and health-related quality of life determinants in geriatric cancer care. Real-world data collection will generate "big data" sets to enable development of predictive algorithms to enable patient risk classification, identification of patients in need for a comprehensive geriatric assessment, and subsequently personalized care.
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Affiliation(s)
- Nikolaos Papachristou
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
| | - Panagiotis Kartsidis
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
| | - Alexandra Anagnostopoulou
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
| | | | - Grigorios Kotronoulas
- School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, United Kingdom
| | | | | | - Ana Santaballa
- University and Polytechnic La Fe Hospital of Valencia, Valencia, Spain
| | | | | | | | - Panagiotis Papachristou
- Academic Primary Health Care Centre, Region Stockholm, Stockholm, Sweden; Department of Neurobiology, Care Science and Society, Division of Family Medicine and Primary Care, Karolinska Institutet, Stockholm, Sweden
| | - Petros Sountoulides
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
| | - Sophia Levva
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
| | - Kelly Avgitidou
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece; Healthink (Medical Research & Innovation, PC), Thessaloniki, Greece
| | - Christiana Tychala
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece; Healthink (Medical Research & Innovation, PC), Thessaloniki, Greece
| | - Costas Bakogiannis
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
| | - Panos Stafylas
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece; Healthink (Medical Research & Innovation, PC), Thessaloniki, Greece
| | | | | | | | | | | | - Antonios Billis
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
| | - Panagiotis D Bamidis
- Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
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Longo UG, Papalia R, De Salvatore S, Casciaro C, Piergentili I, Bandini B, Lalli A, Franceschetti E, Denaro V. Minimal Clinically Important Difference (MCID), Substantial Clinical Benefit (SCB), and Patient Acceptable Symptom State (PASS) of the Shoulder Disability Questionnaire (SDQ) in Patients Undergoing Rotator Cuff Repair. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2023; 20:5950. [PMID: 37297554 PMCID: PMC10252243 DOI: 10.3390/ijerph20115950] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/02/2023] [Revised: 03/13/2023] [Accepted: 05/19/2023] [Indexed: 06/12/2023]
Abstract
The Shoulder Disability Questionnaire (SDQ) is a Patient-Reported Outcome Measure (PROM) applied to evaluate shoulder surgery outcomes. The purpose of this study is to identify the accurate Minimal Clinically Important Difference (MCID), Substantial Clinical Benefit (SCB) and Patient Acceptable Symptom State (PASS) values for the SDQ score. A total of 35 patients (21 women and 16 men, mean age 76.6 ± 3.2 years) were followed up at 6 months postoperatively. To assess the patient's health satisfaction and symptoms, anchor questions were used. The MCID and SCB values of the SDQ score for patients who underwent arthroscopic rotator cuff repair from inception to final follow-up were 40.8 and 55.6, respectively. A change of 40.8 in the SDQ score at 6 months after surgery shows that patients achieved a minimum clinically important improvement in their state of health, and a 55.6 change in the SDQ score reflects a substantial clinically important improvement. The PASS cut-off of the SDQ score at 6 months postoperatively ranged from 22.5 to 25.8. If an SDQ score of 22.5 or more is attained after surgery, the health condition can be recognized as acceptable by the majority of patients. These cut-offs will help with understanding specific patient results and allow clinicians to personally assess patient improvement after rotator cuff repair.
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Affiliation(s)
- Umile Giuseppe Longo
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy
| | - Rocco Papalia
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy
| | - Sergio De Salvatore
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy
| | - Carlo Casciaro
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy
| | - Ilaria Piergentili
- Laboratory of Measurement and Biomedical Instrumentation, Campus Bio-Medico University, Via Alvaro del Portillo, 200, Trigoria, 00128 Rome, Italy
| | - Benedetta Bandini
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy
| | - Alberto Lalli
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy
| | - Edoardo Franceschetti
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy
| | - Vincenzo Denaro
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy
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Sipma WS, de Jong MFC, Meuleman Y, Hemmelder MH, Ahaus K(CTB. Facing the challenges of PROM implementation in Dutch dialysis care: Patients' and professionals' perspectives. PLoS One 2023; 18:e0285822. [PMID: 37186606 PMCID: PMC10184911 DOI: 10.1371/journal.pone.0285822] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/27/2021] [Accepted: 05/02/2023] [Indexed: 05/17/2023] Open
Abstract
BACKGROUND Patient Reported Outcome Measures (PROMs) are increasingly used in routine clinical practice to facilitate patients in sharing and discussing health-related topics with their clinician. This study focuses on the implementation experiences of healthcare professionals and patients during the early implementation phase of the newly developed Dutch set of dialysis PROMs and aims to understand the process of early implementation of PROMs from the users' perspectives. METHODS This is a qualitative study among healthcare professionals (physicians and nursing staff: n = 13) and patients (n = 14) of which 12 were receiving haemodialysis and 2 peritoneal dialysis. Semi-structured interviews were used to understand the barriers and facilitators that both professionals and patients encounter when starting to implement PROMs. RESULTS The early PROM implementation process is influenced by a variety of factors that we divided into barriers and facilitators. We identified four barriers: patient´s indifference to PROMs, scepticism on the benefits of aggregated PROM data, the limited treatment options open to doctors and organizational issues such as mergers, organizational problems and renovations. We also describe four facilitators: professional involvement and patient support, a growing understanding of the use of PROMs during the implementation, quick gains from using PROMs such as receiving instant feedback and a clear ambition on patient care such as a shared view on patient involvement and management support. CONCLUSIONS In this qualitative study carried out during the early implementation phase of the Dutch dialysis PROM set, we found that patients did not yet consider the PROM set to be a useful additional tool to share information with their doctor. This was despite the professionals' primary reason for using PROMs being to improve patient-doctor communication. Furthermore, the perceived lack of intervention options was frustrating for some of the professionals. We found that nurses could be important enablers of further implementation because of their intensive relationship with dialysis patients.
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Affiliation(s)
- Wim S. Sipma
- Department of Health Services Management & Organisation, Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands
| | - Margriet F. C. de Jong
- Department of Nephrology, University Medical Centre Groningen, Groningen, The Netherlands
| | - Yvette Meuleman
- Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, The Netherlands
| | - Marc H. Hemmelder
- Department of Internal Medicine, Division of Nephrology, Maastricht University Medical Centre, Maastricht, The Netherlands
- CARIM school for cardiovascular research, University of Maastricht, Maastricht, The Netherlands
| | - Kees (C.) T. B. Ahaus
- Department of Health Services Management & Organisation, Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands
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Ng CHM, Michelmore AG, Mishra GD, Montgomery GW, Rogers PA, Abbott JA. Establishing the Australian National Endometriosis Clinical and Scientific Trials (NECST) Registry: A protocol paper. REPRODUCTION AND FERTILITY 2023; 4:RAF-23-0014. [PMID: 37224076 PMCID: PMC10305626 DOI: 10.1530/raf-23-0014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2023] [Accepted: 05/23/2023] [Indexed: 05/26/2023] Open
Abstract
Endometriosis is a common yet under-recognised chronic inflammatory disease, affecting 176 million women, trans and gender diverse people globally. The National Endometriosis Clinical and Scientific Trials (NECST) Registry is a new clinical registry, collecting and tracking diagnostic and treatment data, and patient-reported outcomes on people with endometriosis. The registry is a research priority action item from the 2018 National Action Plan for Endometriosis and aims to provide, large-scale, national and longitudinal population-based data on endometriosis. Working groups (consisting of patients with endometriosis, clinicians and researchers) developing the NECST Registry data dictionary and data collection platform started in 2019. Our data dictionary was developed based on existing and validated questionnaires, tools, meta-data and data cubes - World Endometriosis Research Foundation (WERF) Endometriosis Phenome and Biobanking Harmonisation Project (EPHect), endometriosis CORE outcomes set, patient-reported outcome measures, the International Statistical Classification of Diseases-10th Revision Australian Modification diagnosis codes, and Australian Government datasets: Australian Institute for Health and Welfare (for sociodemographic data), Medicare Benefits Schedule (MBS; for medical procedures) and the Pharmaceutical Benefits Scheme (PBS; for medical therapies). The resulting NECST Registry is an online, secure cloud-based database; prospectively collecting minimum core clinical and health data across eight patient and clinician modules and longitudinal data tracking disease life course. The NECST Registry has ethics approval (HREC/62508/MonH-2020) and is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12622000987763).
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Affiliation(s)
- Cecilia H M Ng
- School of Clinical Medicine, Division of Obstetrics and Gynaecology, Health and Medicine, UNSW, Sydney, New South Wales, Australia
- Jean Hailes for Women’s Health, Melbourne, Victoria, Australia
| | | | - Gita D Mishra
- School of Public Health, University of Queensland, Herston, Queensland, Australia
| | - Grant W Montgomery
- Institute of Molecular Bioscience, University of Queensland, St Lucia, Queensland, Australia
| | - Peter A Rogers
- Jean Hailes for Women’s Health, Melbourne, Victoria, Australia
- Department of Obstetrics and Gynaecology, Royal Women’s Hospital, University of Melbourne, Parkville, Victoria, Australia
| | - Jason A Abbott
- School of Clinical Medicine, Division of Obstetrics and Gynaecology, Health and Medicine, UNSW, Sydney, New South Wales, Australia
- Gynaecological Research and Clinical Evaluation (GRACE) Unit, Royal Hospital for Women, Randwick New South Wales, Australia
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Baum L, Johns M, Poikela M, Möller R, Ananthasubramaniam B, Prasser F. Data integration and analysis for circadian medicine. Acta Physiol (Oxf) 2023; 237:e13951. [PMID: 36790321 DOI: 10.1111/apha.13951] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/22/2022] [Revised: 02/04/2023] [Accepted: 02/12/2023] [Indexed: 02/16/2023]
Abstract
Data integration, data sharing, and standardized analyses are important enablers for data-driven medical research. Circadian medicine is an emerging field with a particularly high need for coordinated and systematic collaboration between researchers from different disciplines. Datasets in circadian medicine are multimodal, ranging from molecular circadian profiles and clinical parameters to physiological measurements and data obtained from (wearable) sensors or reported by patients. Uniquely, data spanning both the time dimension and the spatial dimension (across tissues) are needed to obtain a holistic view of the circadian system. The study of human rhythms in the context of circadian medicine has to confront the heterogeneity of clock properties within and across subjects and our inability to repeatedly obtain relevant biosamples from one subject. This requires informatics solutions for integrating and visualizing relevant data types at various temporal resolutions ranging from milliseconds and seconds to minutes and several hours. Associated challenges range from a lack of standards that can be used to represent all required data in a common interoperable form, to challenges related to data storage, to the need to perform transformations for integrated visualizations, and to privacy issues. The downstream analysis of circadian rhythms requires specialized approaches for the identification, characterization, and discrimination of rhythms. We conclude that circadian medicine research provides an ideal environment for developing innovative methods to address challenges related to the collection, integration, visualization, and analysis of multimodal multidimensional biomedical data.
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Affiliation(s)
- Lena Baum
- Berlin Institute of Health at Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Marco Johns
- Berlin Institute of Health at Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Maija Poikela
- Berlin Institute of Health at Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Ralf Möller
- Institute of Information Systems, University of Lübeck, Lübeck, Germany
| | | | - Fabian Prasser
- Berlin Institute of Health at Charité-Universitätsmedizin Berlin, Berlin, Germany
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Kornowski R. Patient-reported outcome measures in cardiovascular disease. EUROPEAN HEART JOURNAL. QUALITY OF CARE & CLINICAL OUTCOMES 2023; 9:119-127. [PMID: 34370009 DOI: 10.1093/ehjqcco/qcab051] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/28/2021] [Accepted: 08/03/2021] [Indexed: 12/13/2022]
Abstract
In today's medical ecosystem, it is vital to measure the outcomes that are most important to the patients. As such, patient-reported outcome measures (PROMS) can be an essential metric to deliver high-quality cardiovascular care, particularly in the subset of patients who remain disappointed with their outcomes. PROMS should be a reproducible and reflective report of what is fundamental to a patient over time and across treatments with proper standards in the analysis, interpretation, and reporting of the collected data. These reports can also be sensitive to changes, whether improvements or deteriorations in the quality of care and medical attitude, but a lack of standardization makes it difficult to draw robust conclusions and compare findings across treatments. As a research tool, PROMS can have a significant prognostic prominence, offering a powerful instrument of comparison between different treatment modalities. With the information technology (IT) abilities of today, we can leverage mobile tools and powerful computer systems to perform sophisticated data analysis using patient-derived data and randomization. This may eliminate guesswork and generate impactful metrics to better inform the decision-making process. PROMS analysed by proper standardized algorithms can avoid physician bias and be integrated into the hospital teamwork. Therefore, there is a strong need for integration of PROMS into the evaluation of cardiovascular interventions and procedures, and establishment of international standards in the analyses of patient-reported outcomes and quality of life data to address this need and develop therapeutic recommendations.
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Affiliation(s)
- Ran Kornowski
- Rabin Medical Center, Belinson & Hasharon Hospitals, Petach Tikva & The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
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de Rooij ENM, Meuleman Y, de Fijter JW, Jager KJ, Chesnaye NC, Evans M, Caskey FJ, Torino C, Porto G, Szymczak M, Drechsler C, Wanner C, Dekker FW, Hoogeveen EK. Symptom Burden before and after Dialysis Initiation in Older Patients. Clin J Am Soc Nephrol 2022; 17:1719-1729. [PMID: 36357126 PMCID: PMC9718015 DOI: 10.2215/cjn.09190822] [Citation(s) in RCA: 28] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/05/2022] [Accepted: 10/14/2022] [Indexed: 11/12/2022]
Abstract
BACKGROUND AND OBJECTIVES For older patients with kidney failure, lowering symptom burden may be more important than prolonging life. Dialysis initiation may affect individual kidney failure-related symptoms differently, but the change in symptoms before and after start of dialysis has not been studied. Therefore, we investigated the course of total and individual symptom number and burden before and after starting dialysis in older patients. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS The European Quality (EQUAL) study is an ongoing, prospective, multicenter study in patients ≥65 years with an incident eGFR ≤20 ml/min per 1.73 m2. Using the dialysis symptom index (DSI), 30 symptoms were assessed every 3-6 months between 2012 and 2021. Scores for symptom number range from zero to 30 and, for burden, from zero to 150, with higher scores indicating more severity. Using mixed effects models, we studied symptoms during the year preceding and the year after dialysis initiation. RESULTS We included 456 incident patients on dialysis who filled out at least one DSI during the year before or after dialysis. At dialysis initiation, mean (SD) participant age was 76 (6) years, 75% were men, mean (SD) eGFR was 8 (3) ml/min per 1.73 m2, 44% had diabetes, and 46% had cardiovascular disease. In the year before dialysis initiation, symptom number increased +3.6 (95% confidence interval [95% CI], +2.5 to +4.6) and symptom burden increased +13.3 (95% CI, +9.5 to +17.0). In the year after, symptom number changed -0.9 (95% CI, -3.4 to +1.5) and burden decreased -5.9 (95% CI, -14.9 to -3.0). At dialysis initiation, "fatigue," "decreased interest in sex," and "difficulty becoming sexually aroused" had the highest prevalence of 81%, 69%, and 68%, respectively, with a burden of 2.7, 2.4, and 2.3, respectively. "Fatigue" somewhat improved after dialysis initiation, whereas the prevalence and burden of sexual symptoms further increased. CONCLUSIONS Symptom burden worsened considerably before and stabilized after dialysis initiation. "Fatigue," "decreased interest in sex," and "difficulty becoming sexually aroused" were considered most burdensome, of which only "fatigue" somewhat improved after dialysis initiation.
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Affiliation(s)
- Esther N M de Rooij
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
- Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands
| | - Yvette Meuleman
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Johan W de Fijter
- Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands
| | - Kitty J Jager
- European Renal Association Registry, Department of Medical Informatics, Academic Medical Center, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, The Netherlands
| | - Nicholas C Chesnaye
- European Renal Association Registry, Department of Medical Informatics, Academic Medical Center, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, The Netherlands
| | - Marie Evans
- Renal Unit, Department of Clinical Intervention and Technology, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden
| | - Fergus J Caskey
- Population Health Sciences, University of Bristol, Bristol, United Kingdom
| | - Claudia Torino
- National Research Council - Institute of Clinical Physiology, Reggio Calabria, Italy
| | - Gaetana Porto
- Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy
| | - Maciej Szymczak
- Department of Nephrology and Transplantation Medicine, Wroclaw Medical University, Wroclaw, Poland
| | | | - Christoph Wanner
- Division of Nephrology, University Hospital of Würzburg, Würzburg, Germany
| | - Friedo W Dekker
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
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van der Willik EM, Milders J, Bart JAJ, Bos WJW, van Ittersum FJ, Ten Dam MAGJ, Hemmelder MH, Dekker FW, Meuleman Y. Discussing results of patient-reported outcome measures (PROMs) between patients and healthcare professionals in routine dialysis care: a qualitative study. BMJ Open 2022; 12:e067044. [PMID: 36396312 PMCID: PMC9677037 DOI: 10.1136/bmjopen-2022-067044] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/19/2022] Open
Abstract
OBJECTIVES Patient-reported outcome measures (PROMs) provide insight into patients' experienced health and needs, and can improve patient-professional communication. However, little is known about how to discuss PROM results. This study aimed to provide in-depth knowledge of patients' and healthcare professionals' experiences with and perspectives on discussing PROM results as part of routine dialysis care. DESIGN A qualitative study was performed using an interpretive description approach. Individual semistructured interviews were conducted with 22 patients and healthcare professionals. Interviews focused on general and specific situations (eg, addressing sensitive topics or when no medical treatment is available). Interviews were transcribed verbatim and analysed inductively using thematic analysis. SETTING Participants were purposively sampled from eight dialysis centres across the Netherlands. PARTICIPANTS Interviews were conducted with 10 patients receiving dialysis treatment and 12 healthcare professionals (nephrologists and nurses). RESULTS Patients and healthcare professionals provided practical guidance for optimal discussion about PROM results. First, patients and healthcare professionals emphasised that PROM results should always be discussed and indicated how to create a suitable setting, adequately prepare, deal with time constraints and use PROMs as a tool for personalised holistic consultations. Second, patients should actively participate and healthcare professionals should take a guiding role. A trusting patient-professional relationship was considered a prerequisite and patient-professional interaction was described as a collaboration in which both contribute their knowledge, experiences and ideas. Third, follow-up after discussing PROM results was considered important, including evaluations and actions (eg, symptom management) structurally embedded into the multidisciplinary treatment process. These general themes also applied to the specific situations, for example: results should also be discussed when no medical treatment is available. Though, healthcare professionals were expected to take more initiative and a leading role when discussing sensitive topics. CONCLUSIONS This study provides insight into how to organise and conduct conversations about PROM results and lays the foundation for training healthcare professionals to optimally discuss PROM results in routine nephrology care. Further research is needed to provide guidance on follow-up actions in response to specific PROM results.
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Affiliation(s)
- Esmee M van der Willik
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Jet Milders
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | | | - Willem Jan W Bos
- Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands
- Department of Internal Medicine, St Antonius Hospital, Nieuwegein, The Netherlands
| | - Frans J van Ittersum
- Department of Nephrology, Amsterdam University Medical Center, Amsterdam, The Netherlands
| | - Marc A G J Ten Dam
- Nefrovisie Foundation, Utrecht, The Netherlands
- Department of Internal Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
| | - Marc H Hemmelder
- Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands
| | - Friedo W Dekker
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Yvette Meuleman
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
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Snyder Valier AR, Huxel Bliven KC, Lam KC, Valovich McLeod TC. Patient-reported outcome measures as an outcome variable in sports medicine research. Front Sports Act Living 2022; 4:1006905. [PMID: 36406772 PMCID: PMC9666499 DOI: 10.3389/fspor.2022.1006905] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/29/2022] [Accepted: 09/26/2022] [Indexed: 11/23/2022] Open
Abstract
Injury prevention and rehabilitation research often address variables that would be considered clinician-oriented outcomes, such as strength, range of motion, laxity, and return-to-sport. While clinician-oriented variables are helpful in describing the physiological recovery from injury, they neglect the patient perspective and aspects of patient-centered care. Variables that capture patient perspective are essential when considering the impact of injury and recovery on the lives of patients. The inclusion of patient-reported outcome measures (PROMs) as dependent variables in sports medicine research, including injury prevention and rehabilitation research, provides a unique perspective regarding the patient's perception of their health status, the effectiveness of treatments, and other information that the patient deems important to their care. Over the last 20 years, there has been a significant increase in the use of PROMs in sports medicine research. The growing body of work gives opportunity to reflect on what has been done and to provide some ideas of how to strengthen the evidence moving forward. This mini-review will discuss ideas for the inclusion of PROMs in sports medicine research, with a focus on critical factors, gaps, and future directions in this area of research. Important elements of research with PROMs, including instrument selection, administration, and interpretation, will be discussed and areas for improvement, consideration, and standardization will be provided.
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Affiliation(s)
- Alison R. Snyder Valier
- Department of Athletic Training, Arizona School of Health Sciences, A.T. Still University, Mesa, AZ, United States,School of Osteopathic Medicine in Arizona, A.T. Still University, Mesa, AZ, United States
| | - Kellie C. Huxel Bliven
- Department of Interdisciplinary Health Sciences, Arizona School of Health Sciences, A.T. Still University, Mesa, AZ, United States
| | - Kenneth C. Lam
- Department of Interdisciplinary Health Sciences, Arizona School of Health Sciences, A.T. Still University, Mesa, AZ, United States
| | - Tamara C. Valovich McLeod
- Department of Athletic Training, Arizona School of Health Sciences, A.T. Still University, Mesa, AZ, United States,School of Osteopathic Medicine in Arizona, A.T. Still University, Mesa, AZ, United States,*Correspondence: Tamara C. Valovich McLeod
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Milella F, Famiglini L, Banfi G, Cabitza F. Application of Machine Learning to Improve Appropriateness of Treatment in an Orthopaedic Setting of Personalized Medicine. J Pers Med 2022; 12:jpm12101706. [PMID: 36294845 PMCID: PMC9604727 DOI: 10.3390/jpm12101706] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/31/2022] [Revised: 09/26/2022] [Accepted: 10/08/2022] [Indexed: 11/07/2022] Open
Abstract
The rise of personalized medicine and its remarkable advancements have revealed new requirements for the availability of appropriate medical decision-making models. Computer science is an area that plays an essential role in the field of personalized medicine, where one of the goals is to provide algorithms and tools to extrapolate knowledge and improve the decision-support process. The minimum clinically important difference (MCID) is the smallest change in PROM scores that patients perceive as meaningful. Treatment that does not achieve the minimum level of improvement is considered inappropriate as well as a potential waste of resources. Using the MCID threshold to identify patients who fail to achieve the minimum change in PROM that results in a meaningful outcome may aid in pre-surgical shared decision-making. The decision tree algorithm is a method for extracting valuable information and providing further meaningful information to the domain expert that supports the decision-making. In the present study, different tools based on machine learning were developed. On the one hand, we compared three XGBoost models to predict the non-achievement of the MCID at six months post-operation in the SF-12 physical score. The prediction score threshold was set to 0.75 to provide three decision-making areas on the basis of the high confidence (HC) intervals; the minority class was re-balanced by weighting the positive class to penalize the loss function (XGBoost cost-sensitive), oversampling the minority class (XGBoost with SMOTE), and re-sampling the negative class (XGBoost with undersampling). On the other hand, we modeled the data through a decision tree (assessment tree), based on different complexity levels, to identify the hidden pattern and to provide a new way to understand possible relationships between the gathered features and the several outcomes. The results showed that all the proposed models were effective as binary classifiers, as they showed moderate predictive performance both regarding the minority or positive class (i.e., our targeted patients, those who will not benefit from surgery) and the negative class. The decision tree visualization can be exploited during the patient assessment status to better understand if those patients will benefit or not from the medical intervention. Both of these tools can come in handy for increasing knowledge about the patient’s psychophysical state and for creating an increasingly specialized assessment of the individual patient.
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Affiliation(s)
- Frida Milella
- IRCCS Istituto Ortopedico Galeazzi, Via Cristina Belgioioso 173, 20157 Milano, Italy
- Correspondence:
| | - Lorenzo Famiglini
- DISCo, Dipartimento di Informatica, Sistemistica e Comunicazione, University of Milano–Bicocca, Viale Sarca 336, 20126 Milano, Italy
| | - Giuseppe Banfi
- IRCCS Istituto Ortopedico Galeazzi, Via Cristina Belgioioso 173, 20157 Milano, Italy
- Faculty of Medicine and Surgery, Università Vita-Salute San Raffaele, 20132 Milano, Italy
| | - Federico Cabitza
- IRCCS Istituto Ortopedico Galeazzi, Via Cristina Belgioioso 173, 20157 Milano, Italy
- DISCo, Dipartimento di Informatica, Sistemistica e Comunicazione, University of Milano–Bicocca, Viale Sarca 336, 20126 Milano, Italy
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Murea M, Highland BR, Yang W, Dressler E, Russell GB. Patient-reported outcomes in a pilot clinical trial of twice-weekly hemodialysis start with adjuvant pharmacotherapy and transition to thrice-weekly hemodialysis vs conventional hemodialysis. BMC Nephrol 2022; 23:322. [PMID: 36167537 PMCID: PMC9513956 DOI: 10.1186/s12882-022-02946-w] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2022] [Accepted: 09/13/2022] [Indexed: 11/24/2022] Open
Abstract
Background Physical and emotional symptoms are prevalent in patients with kidney-dysfunction requiring dialysis (KDRD) and the rigors of thrice-weekly hemodialysis (HD) may contribute to deteriorated health-related quality of life. Less intensive HD schedules might be associated with lower symptom and/or emotional burden. Methods The TWOPLUS Pilot study was an individually-randomized trial conducted at 14 dialysis units, with the primary goal to assess feasibility and safety. Patients with incident KDRD and residual kidney function were assigned to incremental HD start (twice-weekly HD for 6 weeks followed by thrice-weekly HD) vs conventional HD (thrice-weekly HD). In exploratory analyses, we compared the two treatment groups with respect to three patient-reported outcomes measures. We analyzed the change from baseline in the score on Dialysis Symptom Index (DSI, range 0–150), Generalized Anxiety Disorder-7 (GAD-7, range 0–21), and Patient Health Questionnaire-9 (PHQ-9, range 0–27) at 6 (n = 20 in each treatment group) and 12 weeks (n = 21); with lower scores denoting lower symptom burden. Analyses were adjusted for age, race, gender, baseline urine volume, diabetes mellitus, and malignancy. Participants’ views on the intervention were sought using a Patient Feedback Questionnaire (n = 14 in incremental and n = 15 in conventional group). Results The change from baseline to week 6 in estimated mean score (standard error; P value) in the incremental and conventional group was − 9.7 (4.8; P = 0.05) and − 13.8 (5.0; P = 0.009) for DSI; − 1.9 (1.0; P = 0.07) and − 1.5 (1.4; P = 0.31) for GAD-7; and − 2.5 (1.1; P = 0.03) and − 3.5 (1.5; P = 0.02) for PHQ-9, respectively. Corresponding changes from week 6 to week 12 were − 3.1 (3.2; P = 0.34) and − 2.4 (5.5; P = 0.67) in DSI score; 0.5 (0.6; P = 0.46) and 0.1 (0.6; P = 0.87) in GAD-7 score; and − 0.3 (0.6; P = 0.70) and − 0.5 (0.6; P = 0.47) in PHQ-9 score, respectively. Majority of respondents felt their healthcare was not jeopardized and expressed their motivation for study participation was to help advance the care of patients with KDRD. Conclusions This study suggests a possible mitigating effect of twice-weekly HD start on symptoms of anxiety and depression at transition from pre-dialysis to KDRD. Larger clinical trials are required to rigorously test clinically-matched incrementally-prescribed HD across diverse organizations and patient populations. Trial registration Registered at ClinicalTrials.gov with study identifier NCT03740048, registration date 14/11/2018. Supplementary Information The online version contains supplementary material available at 10.1186/s12882-022-02946-w.
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Affiliation(s)
- Mariana Murea
- Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157-1053, USA.
| | - Benjamin R Highland
- Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA
| | - Wesley Yang
- Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA
| | - Emily Dressler
- Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA
| | - Gregory B Russell
- Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA
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Consolo L, Castellini G, Cilluffo S, Basile I, Lusignani M. Electronic patient-reported outcomes (e-PROMs) in palliative cancer care: a scoping review. J Patient Rep Outcomes 2022; 6:102. [PMID: 36138279 PMCID: PMC9500127 DOI: 10.1186/s41687-022-00509-z] [Citation(s) in RCA: 26] [Impact Index Per Article: 8.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2022] [Accepted: 09/12/2022] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND In palliative oncology settings, electronic patient-reported outcome (PRO) assessment can play an important role in supporting clinical activities for clinicians and patients. This scoping review aims to map the technological innovation of electronic patient-reported outcome measures (e-PROMs) in cancer palliative care and how PRO data collected through e-PROMs can influence the monitoring and management of symptoms and enable better communication between health professionals and patients. METHODS A scoping review study was designed according to the Arksey and O'Malley framework. Medline, Embase, Web of Science, SCOPUS, PsycINFO and CINAHL and gray literature sources were consulted. The inclusion criteria were people over 18 years old receiving palliative and/or end-of-life care using e-PROMs. RESULTS Thirteen primary studies were included: nine quantitative studies, two qualitative studies, and two mixed-method studies. The recently developed software that supports e-PROMs allows patients to receive feedback on their symptoms, helps clinicians prioritize care needs and monitors patients' conditions as their symptoms change. Electronic PRO data prompt difficult, end-of-life communication between clinicians and patients to better organize care in the last phase of life. CONCLUSION This work shows that electronic PRO data assessment provides valuable tools for patients' well-being and the management of symptoms; only one study reported conflicting results. However, with studies lacking on how clinicians can use these tools to improve communication with patients, more research is needed.
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Affiliation(s)
- Letteria Consolo
- Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, Rome, Italy
- Bachelor School of Nursing, IRCCS, National Cancer Institute, Milan, Italy
| | - Greta Castellini
- Unit of Clinical Epidemiology, IRCCS Galeazzi Orthopaedic Institute, Milan, Italy
| | - Silvia Cilluffo
- Bachelor School of Nursing, ASST Grande Ospedale Metropolitano Niguarda, University, Milan, Italy
| | - Ilaria Basile
- Palliative Care, Pain Therapy and Rehabilitation Unit, IRCCS, National Cancer Institute, Milan, Italy
| | - Maura Lusignani
- Associate Professor, Department of Biomedical Sciences for Health, University of Milan, Milan, Italy
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Ernst SCK, Steinbeck V, Busse R, Pross C. Toward System-Wide Implementation of Patient-Reported Outcome Measures: A Framework for Countries, States, and Regions. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2022; 25:1539-1547. [PMID: 35610145 DOI: 10.1016/j.jval.2022.04.1724] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/16/2021] [Revised: 03/29/2022] [Accepted: 04/10/2022] [Indexed: 06/15/2023]
Abstract
OBJECTIVES This study aimed to develop a framework facilitating (1) the maturity assessment of healthcare systems regarding patient-reported outcome measure (PROM) implementation and (2) the comparison of different healthcare systems' PROM implementation levels to guide discussions and derive lessons for regional, state-level, and national PROM initiatives. METHODS Guided by the grounded theory methodology, a PROM healthcare system implementation framework was developed following multiple steps. Based on interviews with 28 experts from 12 countries and a literature review, a framework was drafted and refined through 29 additional validation interviews. RESULTS The resulting framework comprises 5 implementation stages along 7 dimensions. Implementation stages range from "first experimentation" to "system-wide adoption and a vibrant ecosystem." The dimensions are grouped into patient-reported outcome (PRO) measurement and PRO utilization, the former with the dimensions "scope and condition coverage," "metric and process standardization," and "tools and information technology-based solutions" and the latter with "patient empowerment and clinical decision support," "reporting and quality improvement," and "rewarding and contracting." The "culture and stakeholder involvement" dimension connects both groups. Although a concerted implementation approach across dimensions can be observed in advanced countries, others show a more uneven adoption. CONCLUSIONS The framework and its preliminary application to different healthcare systems demonstrate (1) the importance of coherent progress across complementing dimensions and (2) the relevance of PROM integration across clinical specialties and care sectors to strengthen patient-centered care. Overall, the framework can facilitate dialogues between stakeholders to analyze the current PROM implementation status and strategies to advance it.
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Affiliation(s)
- Sophie-Christin Kornelia Ernst
- Faculty of Economics and Management, Department of Health Care Management, Technical University of Berlin, Berlin, Germany.
| | - Viktoria Steinbeck
- Faculty of Economics and Management, Department of Health Care Management, Technical University of Berlin, Berlin, Germany
| | - Reinhard Busse
- Faculty of Economics and Management, Department of Health Care Management, Technical University of Berlin, Berlin, Germany
| | - Christoph Pross
- Faculty of Economics and Management, Department of Health Care Management, Technical University of Berlin, Berlin, Germany
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van der Willik EM, van Breda F, van Jaarsveld BC, van de Putte M, Jetten IW, Dekker FW, Meuleman Y, van Ittersum FJ, Terwee CB. Validity and reliability of Patient-Reported Outcomes Measurement Information System (PROMIS®) using Computerized Adaptive Testing (CAT) in patients with advanced chronic kidney disease. Nephrol Dial Transplant 2022; 38:1158-1169. [PMID: 35913734 PMCID: PMC10157750 DOI: 10.1093/ndt/gfac231] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/07/2022] [Indexed: 11/14/2022] Open
Abstract
BACKGROUND The Patient-Reported Outcomes Measurement Information System (PROMIS®) has been recommended for computerized adaptive testing (CAT) of health-related quality of life (HRQOL). This study compared the content, validity and reliability of seven PROMIS CATs to the 12-item Short-Form Health Survey (SF-12) in patients with advanced chronic kidney disease (CKD). METHODS Adult CKD patients with an eGFR < 30 ml/min.1.73m2 not receiving dialysis treatment completed seven PROMIS CATs (assessing physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and ability to participate in social roles and activities), the SF-12 and, additionally, the PROMIS Pain Intensity single item and Dialysis Symptom Index (DSI) at inclusion and 2-weeks. A content comparison was performed between PROMIS CATs and SF-12. Construct validity of PROMIS CATs was assessed using Pearson's correlations. Test-retest reliability of all patient-reported outcome measures (PROMs) was assessed by calculating the intra-class correlation coefficient (ICC) and minimal detectable change (MDC). RESULTS In total, 207 patients participated in the study. A median of 45 items (10 minutes) was completed for PROMIS CATs. All PROMIS CATs showed evidence for sufficient construct validity. PROMIS CATs, most SF-12 domains and summary scores, and DSI showed sufficient test-retest reliability (ICC ≥ 0.70). PROMIS CATs had a lower MDC compared to the SF-12 (5.7-7.4 compared to 11.2-21.7 across domains, respectively). CONCLUSION PROMIS CATs showed sufficient construct validity and test-retest reliability in patients with advanced CKD. PROMIS CATs required more items but showed better reliability than the SF-12. Future research is needed to investigate the feasibility of PROMIS CATs for routine nephrology care.
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Affiliation(s)
- Esmee M van der Willik
- Department of Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Amsterdam, The Netherlands.,Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Fenna van Breda
- Department of Nephrology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
| | - Brigit C van Jaarsveld
- Department of Nephrology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
| | - Marlon van de Putte
- Department of Nephrology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
| | - Isabelle W Jetten
- Department of Nephrology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
| | - Friedo W Dekker
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Yvette Meuleman
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Frans J van Ittersum
- Department of Nephrology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
| | - Caroline B Terwee
- Department of Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Amsterdam, The Netherlands
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Viecelli AK, Duncanson E, Bennett PN, D'Antoine M, Dansie K, Handke W, Tong A, Palmer S, Jesudason S, McDonald S, Morton RL. Perspectives of Patients, Nurses, and Nephrologists About Electronic Symptom Monitoring With Feedback in Hemodialysis Care. Am J Kidney Dis 2022; 80:215-226.e1. [PMID: 35085687 DOI: 10.1053/j.ajkd.2021.12.007] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/02/2021] [Accepted: 12/03/2021] [Indexed: 01/27/2023]
Abstract
RATIONALE & OBJECTIVE Patients receiving hemodialysis experience high symptom burden and low quality of life (QOL). Electronic patient-reported outcome measures (e-PROMs) monitoring with feedback to clinicians may be an acceptable intervention to improve health-related QOL for patients receiving hemodialysis. This study explored patient and clinician perspectives on e-PROMs monitoring with feedback to clinicians. STUDY DESIGN Qualitative study. SETTING & PARTICIPANTS 41 participants (12 patients, 13 nephrologists, 16 dialysis nurses) who participated in a 6-month feasibility pilot study of adults receiving facility-based hemodialysis across 4 Australian units. The intervention consisted of electronic symptom monitoring with feedback to clinicians, who also received evidence-based symptom management recommendations to improve health-related QOL. ANALYTICAL APPROACH Semistructured interviews and focus group discussions explored the feasibility and acceptability of e-PROMs monitoring with feedback to clinicians. We conducted a thematic analysis of transcripts. RESULTS We identified 4 themes: enabling efficient, systematic, and multidisciplinary patient-centered care; experiencing limited data and options for symptom management; requiring familiarity with technology and processes; and identifying barriers and competing priorities. While insufficient patient engagement, logistic/technical challenges, and delayed symptom feedback emerged as barriers to implementation, active engagement by nurses in encouraging and supporting patients during survey completion and clinicians' prompt action after symptom feedback were considered to be facilitators to implementation. LIMITATIONS Limited generalizability due to inclusion of English-speaking participants only. CONCLUSIONS Patients, nurses, and nephrologists considered e-PROMs monitoring with feedback to clinicians feasible for symptom management in hemodialysis. Clinician engagement, patient support, reliable technology, timely symptom feedback, and interventions to address symptom burden are likely to improve its implementation within research and clinical settings.
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Affiliation(s)
- Andrea K Viecelli
- Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia
| | - Emily Duncanson
- Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute, Adelaide, Australia; Central Northern Adelaide Renal and Transplantation Service, Adelaide, Australia
| | - Paul N Bennett
- Clinical & Health Sciences, University of South Australia, Adelaide, Australia; Medical and Clinical Affairs, Satellite Healthcare, San Jose, California
| | - Matilda D'Antoine
- Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute, Adelaide, Australia
| | - Kathryn Dansie
- Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute, Adelaide, Australia
| | | | - Allison Tong
- Centre for Kidney Research, Children's Hospital at Westmead, Westmead, Australia; Sydney School of Public Health, University of Sydney, Sydney, Australia
| | - Suetonia Palmer
- Department of Medicine, University of Otago, Christchurch, New Zealand
| | - Shilpanjali Jesudason
- Central Northern Adelaide Renal and Transplantation Service, Adelaide, Australia; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia
| | - Stephen McDonald
- Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute, Adelaide, Australia; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia
| | - Rachael L Morton
- NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.
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de Rooij EN, Meuleman Y, de Fijter JW, Le Cessie S, Jager KJ, Chesnaye NC, Evans M, Pagels AA, Caskey FJ, Torino C, Porto G, Szymczak M, Drechsler C, Wanner C, Dekker FW, Hoogeveen EK. Quality of Life before and after the Start of Dialysis in Older Patients. Clin J Am Soc Nephrol 2022; 17:1159-1167. [PMID: 35902127 PMCID: PMC9435986 DOI: 10.2215/cjn.16371221] [Citation(s) in RCA: 18] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2021] [Accepted: 06/01/2022] [Indexed: 01/27/2023]
Abstract
BACKGROUND AND OBJECTIVES In older people with kidney failure, improving health-related quality of life is often more important than solely prolonging life. However, little is known about the effect of dialysis initiation on health-related quality of life in older patients. Therefore, we investigated the evolution of health-related quality of life before and after starting dialysis in older patients with kidney failure. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS The European Quality study is an ongoing prospective, multicenter study in patients aged ≥65 years with an incident eGFR ≤20 ml/min per 1.73 m2. Between April 2012 and December 2021, health-related quality of life was assessed every 3-6 months using the 36-item Short-Form Health Survey (SF-36), providing a mental component summary (MCS) and a physical component summary (PCS). Scores range from zero to 100, with higher scores indicating better health-related quality of life. With linear mixed models, we explored the course of health-related quality of life during the year preceding and following dialysis initiation. RESULTS In total, 457 patients starting dialysis were included who filled out at least one SF-36 during follow-up. At dialysis initiation, mean ± SD age was 76±6 years, eGFR was 8±3 ml/min per 1.73 m2, 75% were men, 9% smoked, 45% had diabetes, and 46% had cardiovascular disease. Median (interquartile range) MCS was 53 (38-73), and median PCS was 39 (27-58). During the year preceding dialysis, estimated mean change in MCS was -13 (95% confidence interval, -17 to -9), and in PCS, it was -11 (95% confidence interval, -15 to -7). In the year following dialysis, estimated mean change in MCS was +2 (95% confidence interval, -7 to +11), and in PCS, it was -2 (95% confidence interval, -11 to +7). Health-related quality-of-life patterns were similar for most mental (mental health, role emotional, social functioning, vitality) and physical domains (physical functioning, bodily pain, role physical). CONCLUSIONS Patients experienced a clinically relevant decline of both mental and physical health-related quality of life before dialysis initiation, which stabilized thereafter. These results may help inform older patients with kidney failure who decided to start dialysis.
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Affiliation(s)
- Esther N.M. de Rooij
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands,Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands
| | - Yvette Meuleman
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Johan W. de Fijter
- Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands
| | - Saskia Le Cessie
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands,Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands
| | - Kitty J. Jager
- European Renal Association Registry, Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
| | - Nicholas C. Chesnaye
- European Renal Association Registry, Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
| | - Marie Evans
- Renal Unit, Department of Clinical Intervention and Technology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
| | - Agneta A. Pagels
- Department of Medicine, Karolinska Institute, Stockholm, Sweden,Department of Nephrology, Karolinska University Hospital, Stockholm, Sweden
| | - Fergus J. Caskey
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom
| | - Claudia Torino
- Institute of Clinical Physiology-National Research Council, Clinical Epidemiology and Pathophysiology of Renal Diseases and Hypertension, Reggio Calabria, Italy
| | - Gaetana Porto
- Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy
| | - Maciej Szymczak
- Department of Nephrology and Transplantation Medicine, Wroclaw Medical University, Wroclaw, Poland
| | | | - Christoph Wanner
- Division of Nephrology, University Hospital of Wurzburg, Wurzburg, Germany
| | - Friedo W. Dekker
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Ellen K. Hoogeveen
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands,Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands,Department of Nephrology, Jeroen Bosch Hospital, Den Bosch, The Netherlands
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Nadort E, Rijkers N, Schouten RW, Hoogeveen EK, Bos WJ, Vleming LJ, Westerman M, Schouten M, Dekker MJ, Smets YF, Shaw PC, Farhat K, Dekker FW, van Oppen P, Siegert CE, Broekman BF. Depression, anxiety and quality of life of hemodialysis patients before and during the COVID-19 pandemic. J Psychosom Res 2022; 158:110917. [PMID: 35462121 PMCID: PMC9008976 DOI: 10.1016/j.jpsychores.2022.110917] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/18/2021] [Revised: 04/08/2022] [Accepted: 04/10/2022] [Indexed: 12/16/2022]
Abstract
OBJECTIVE To investigate the impact of the coronavirus pandemic on mental health in hemodialysis patients, we assessed depression, anxiety and quality of life with valid mental health measures before and after the start of the pandemic. METHODS Data were used from 121 hemodialysis patients from the ongoing prospective multicenter DIVERS-II study. COVID-19 related stress was measured with the Perceived Stress Scale - 10, depression with the Beck Depression Inventory - second edition (BDI-II)), anxiety with the Beck Anxiety Inventory (BAI) and quality of life with the Short Form - 12 (SF-12). Scores during the first and second COVID-19 wave in the Netherlands were compared to data prior to the pandemic with linear mixed models. RESULTS No significant differences were found in BDI-II, BAI and SF-12 scores between before and during the pandemic. During the first wave, 33% of participants reported COVID-19 related stress and in the second wave 37%. These patients had higher stress levels (mean difference (MD) 4.7 (95%CI 1.5; 8.0), p = 0.005) and BDI-II scores (MD 4.9 (95%CI 0.7; 9.0), p = 0.021) and lower SF-12 mental component summary scores (MD -5.3 (95%CI -9.0, -1.6), p = 0.006) than patients who did not experienced COVID-19 stress. These differences were already present before the pandemic. CONCLUSION The COVID-19 pandemic does not seem to influence mental health in hemodialysis patients. However, a substantial subgroup of patients with pre-existent mental health problems may be more susceptible to experience COVID-19 related stress.
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Affiliation(s)
- Els Nadort
- Department of Psychiatry, OLVG, Amsterdam, the Netherlands; Department of Psychiatry, Amsterdam University Medical Centre and GGZ inGeest, Amsterdam, the Netherlands.
| | - Nadine Rijkers
- Department of Psychiatry, OLVG, Amsterdam, the Netherlands.
| | | | - Ellen K. Hoogeveen
- Department of Nephrology, Jeroen Bosch Ziekenhuis, Den Bosch, the Netherlands,Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands
| | - Willem J.W. Bos
- Department of Internal Medicine, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands,Department of Internal Medicine, Leiden University Medical Centre, Leiden, the Netherlands
| | | | - Michiel Westerman
- Department of Nephrology, Franciscus Gasthuis & Vlietland Ziekenhuis, Rotterdam, the Netherlands.
| | - Marcel Schouten
- Department of Nephrology, Tergooi Ziekenhuis, Hilversum, the Netherlands.
| | | | | | - Prataap Chandie Shaw
- Department of Nephrology, Haaglanden Medisch Centrum, The Hague, the Netherlands.
| | - Karima Farhat
- Department of Nephrology, Spaarne Gasthuis, Haarlem, the Netherlands.
| | - Friedo W. Dekker
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands
| | - Patricia van Oppen
- Department of Psychiatry, Amsterdam University Medical Centre and GGZ inGeest, Amsterdam, the Netherlands.
| | | | - Birit F.P. Broekman
- Department of Psychiatry, OLVG, Amsterdam, the Netherlands,Department of Psychiatry, Amsterdam University Medical Centre and GGZ inGeest, Amsterdam, the Netherlands
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Patient Judgement of Change with Elective Surgery Correlates with Patient Reported Outcomes and Quality of Life. Healthcare (Basel) 2022; 10:healthcare10060999. [PMID: 35742049 PMCID: PMC9222512 DOI: 10.3390/healthcare10060999] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/04/2022] [Revised: 05/23/2022] [Accepted: 05/25/2022] [Indexed: 01/27/2023] Open
Abstract
Obtaining pre-surgery PROM measures is not always feasible. The aim of this study was to examine if self-reports of change following elective surgery correlate with change scores from a validated PROM (15-item Quality of Recovery (QoR-15)). This cross-sectional study across 29 hospitals enrolled elective surgery patients. PROMs were collected one-week pre-surgery, as well as one- and four-weeks post-surgery via an electronic survey. We examined associations between patient “judgement of change” at one and four-weeks after surgery and the actual pre-to post-surgery PROM change scores. A total of 4177 surveys were received. The correlation between patient judgement of change, and the actual change score was moderately strong at one-week (n = 247, rs = 0.512, p < 0.001), yet low at four-weeks (n = 241, rs = 0.340, p < 0.001). Patient judgement was aligned to the direction of the PROM change score from pre- to post-surgery. We also examined the correlation between the QoR-15 (quality of recovery) and the EQ-5D-5L (QOL). There was a moderately strong positive correlation between the two PROMs (n = 356, rs = 0.666, p < 0.001), indicating that change in quality of recovery was related to change in QOL. These findings support the use of a single “judgement of change” recall question post-surgery.
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van der Willik EM, Lengton R, Hemmelder MH, Hoogeveen EK, Bart HAJ, van Ittersum FJ, ten Dam MAGJ, Bos WJW, Dekker FW, Meuleman Y. Itching in dialysis patients: impact on health-related quality of life and interactions with sleep problems and psychological symptoms – results from the RENINE/PROMs registry. Nephrol Dial Transplant 2022; 37:1731-1741. [PMID: 35098998 PMCID: PMC9395377 DOI: 10.1093/ndt/gfac022] [Citation(s) in RCA: 19] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2021] [Indexed: 11/15/2022] Open
Abstract
Background Itching (pruritus) is common in dialysis patients, but little is known about its impact on health-related quality of life (HRQOL), sleep problems and psychological symptoms. This study investigates the impact of itching in dialysis patients by looking into the persistence of itching, the effect of itching on the course of HRQOL and the combined effect of itching with sleep problems and with psychological symptoms on HRQOL. Methods Data were obtained from the RENINE/PROMs registry and included 2978 dialysis patients who completed patient-reported outcome measures between 2018 and 2020. Itching, sleep problems and psychological symptoms were assessed with the Dialysis Symptom Index (DSI) and HRQOL with the 12-item Short Form Health Survey. Effects of itching on HRQOL and interactions with sleep problems and psychological symptoms were investigated cross-sectionally and longitudinally using linear regression and linear mixed models. Results Half of the patients experienced itching and in 70% of them, itching was persistent. Itching was associated with a lower physical and mental HRQOL {−3.35 [95% confidence interval (CI) −4.12 to −2.59) and −3.79 [95% CI −4.56 to −3.03]}. HRQOL remained stable during 2 years and trajectories did not differ between patients with or without itching. Sleep problems (70% versus 52%) and psychological symptoms (36% versus 19%) were more common in patients with itching. These symptoms had an additional negative effect on HRQOL but did not interact with itching. Conclusions The persistence of itching, its impact on HRQOL over time and the additional effect on HRQOL of sleep problems and psychological symptoms emphasize the need for recognition and effective treatment of itching to reduce symptom burden and improve HRQOL.
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Affiliation(s)
- Esmee M van der Willik
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Robin Lengton
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Marc H Hemmelder
- Department of Internal Medicine, Maastricht University Medical Center and CARIM school for cardiovascular diseases, Maastricht University, Maastricht, The Netherlands
| | - Ellen K Hoogeveen
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
- Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands
- Department of Nephrology, Jeroen Bosch Hospital, Den Bosch, The Netherlands
| | - Hans A J Bart
- Dutch Kidney Patients Association (NVN), Bussum, The Netherlands
| | - Frans J van Ittersum
- Department of Nephrology, Amsterdam University Medical Center, Amsterdam, The Netherlands
| | - Marc A G J ten Dam
- Nefrovisie Foundation, Utrecht, The Netherlands
- Department of Internal Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
| | - Willem Jan W Bos
- Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands
- Department of Internal Medicine, St Antonius Hospital, Nieuwegein, The Netherlands
| | - Friedo W Dekker
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Yvette Meuleman
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
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47
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Jacklin C, Rodrigues JN, Collins J, Cook J, Harrison CJ. Sample size calculations in high-profile surgical trials that use patient-reported outcome measures: systematic review. Br J Surg 2021; 109:178-181. [PMID: 34915565 DOI: 10.1093/bjs/znab421] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/26/2021] [Accepted: 11/10/2021] [Indexed: 11/14/2022]
Abstract
Sample size calculations from high-profile surgical RCTs that used a patient-reported outcome measure as primary outcome were reviewed systematically against Difference ELicitation in TriAls (DELTA2) standards, with a focus on target differences. In this sample of trials, there was frequent use of suboptimal methods to determine the target difference, and sample size calculations were generally not reported to DELTA2 standards. This risks over-recruitment and/or erroneous trial conclusions, which clinicians should be aware of when interpreting published trials.
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Affiliation(s)
- Chloe Jacklin
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
| | - Jeremy N Rodrigues
- Department of Plastic Surgery, Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, UK.,Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
| | - Joanna Collins
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
| | - Jonathan Cook
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
| | - Conrad J Harrison
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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Voorend CGN, van Oevelen M, Nieberg M, Meuleman Y, Franssen CFM, Joosten H, Berkhout-Byrne NC, Abrahams AC, Mooijaart SP, Bos WJW, van Buren M. Impact of the COVID-19 pandemic on symptoms of anxiety and depression and health-related quality of life in older patients with chronic kidney disease. BMC Geriatr 2021; 21:650. [PMID: 34798817 PMCID: PMC8602979 DOI: 10.1186/s12877-021-02593-0] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/15/2021] [Accepted: 10/18/2021] [Indexed: 12/19/2022] Open
Abstract
BACKGROUND Older patients with advanced chronic kidney disease are at increased risk for a severe course of the coronavirus disease-2019 (COVID-19) and vulnerable to mental health problems. We aimed to investigate prevalence and associated patient (demographic and clinical) characteristics of mental wellbeing (health-related quality of life [HRQoL] and symptoms of depression and anxiety) before and during the COVID-19 pandemic in older patients with advanced chronic kidney disease. METHODS An ongoing Dutch multicentre prospective cohort study enrols patients of ≥70 years with an eGFR < 20 mL/min/1.73m2 from October 2018 onward. With additional questionnaires during the pandemic (May-June 2020), disease-related concerns about COVID-19 and general anxiety symptoms were assessed cross-sectionally, and depressive symptoms, HRQoL, and emotional symptoms longitudinally. RESULTS The 82 included patients had a median age of 77.5 years (interquartile range 73.9-82.1), 77% were male and none had tested positive for COVID-19. Cross-sectionally, 67% of the patients reported to be more anxious about COVID-19 because of their kidney disease, and 43% of the patients stated that their quality of life was reduced due to the COVID-19 pandemic. Compared to pre-COVID-19, the presence of depressive symptoms had increased (11 to 22%; p = .022) and physical HRQoL declined (M = 40.4, SD = 10.1 to M = 36.1, SD = 10.4; p < .001), particularly in males. Mental HRQoL (M = 50.3, SD = 9.6 to M = 50.4, SD = 9.9; p = .913) and emotional symptoms remained similar. CONCLUSIONS Older patients with advanced chronic kidney disease suffered from disease-related anxiety about COVID-19, increased depressive symptoms and reduced physical HRQoL during the COVID-19 pandemic. The impact of the pandemic on this vulnerable patient group extends beyond increased mortality risk, and awareness of mental wellbeing is important. TRIAL REGISTRATION The study is registered at the Netherlands Trial Register (NTR), trial number NL7104. Date of registration: 06-06-2018.
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Affiliation(s)
- C G N Voorend
- Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.
| | - M van Oevelen
- Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
| | - M Nieberg
- Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
| | - Y Meuleman
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - C F M Franssen
- Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
| | - H Joosten
- Department of Internal Medicine, Division of General Internal Medicine, Section Geriatric Medicine, Maastricht University Medical Center+, Maastricht, The Netherlands
| | - N C Berkhout-Byrne
- Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
| | - A C Abrahams
- Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands
| | - S P Mooijaart
- Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, The Netherlands
| | - W J W Bos
- Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.,Department of Internal Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands
| | - M van Buren
- Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.,Department of Internal Medicine, Haga Teaching Hospital, The Hague, The Netherlands
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White D, Englezou C, Rajabally YA. Patient perceptions of outcome measures in chronic inflammatory demyelinating polyneuropathy: A study of the Inflammatory Rasch-built Overall Disability Scale. Eur J Neurol 2021; 28:2596-2602. [PMID: 33969583 DOI: 10.1111/ene.14907] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2021] [Revised: 04/12/2021] [Accepted: 04/28/2021] [Indexed: 12/24/2022]
Abstract
BACKGROUND Patients' perceptions of outcome measures used in chronic inflammatory demyelinating polyneuropathy (CIDP) are unknown. METHODS We performed a cross-sectional evaluation of patient perceptions of the Inflammatory Rasch-built Overall Disability Scale (I-RODS) from 41 subjects with CIDP through a structured questionnaire. We assessed perceived hesitation to provide a response, item importance and relevance, understanding of specific items and factors affecting responses. RESULTS Hesitation to provide a categorical answer was reported by 20% of subjects or more, for 5/24 (20.8%) items. Uncertainty was most frequent for "travel by public transport" (22.4%) and "catch an object (e.g., ball)" (24%). Six of 24 (25%) items were perceived as unimportant to their disease by at least a third of participants. Items most commonly perceived as unimportant were "travel by public transport" in 53.7%, "catch an object (e.g., ball)" in 61% and "dance" in 65.9%. Several items were frequently perceived as irrelevant. These included "move a chair" (39%), "do the dishes" (46.3%), "catch an object (e.g., ball)" (61%), "travel by public transport" (68.3%) and "stand for hours" (82.9%). The understanding of multiple items such as "read a book", "sit on a toilet" and "take a shower" was found to be highly variable. Fatigue was perceived more commonly than mood (53.7% vs. 17.1%, p = 0.001), and more commonly in younger subjects (p = 0.037), as influencing responses to the I-RODS. CONCLUSIONS Patient-perceived uncertainty, unimportance, irrelevance and poor understanding of items, as well as fatigue and mood, impact on the value of the I-RODS. Greater emphasis on individualized disability assessments requires consideration in future.
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Affiliation(s)
- Daniel White
- Inflammatory Neuropathy Clinic, Department of Neurology, University Hospitals Birmingham, Birmingham, UK
| | - Christina Englezou
- Inflammatory Neuropathy Clinic, Department of Neurology, University Hospitals Birmingham, Birmingham, UK
| | - Yusuf A Rajabally
- Inflammatory Neuropathy Clinic, Department of Neurology, University Hospitals Birmingham, Birmingham, UK.,Aston Medical School, Aston University, Birmingham, UK
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50
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van der Willik EM, Terwee CB, Bos WJW, Hemmelder MH, Jager KJ, Zoccali C, Dekker FW, Meuleman Y. Patient-reported outcome measures ( PROMs): making sense of individual PROM scores and changes in PROM scores over time. Nephrology (Carlton) 2021; 26:391-399. [PMID: 33325638 PMCID: PMC8048666 DOI: 10.1111/nep.13843] [Citation(s) in RCA: 34] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2020] [Accepted: 12/12/2020] [Indexed: 01/30/2023]
Abstract
Patient-reported outcome measures (PROMs) are increasingly being used in nephrology care. However, in contrast to well-known clinical measures such as blood pressure, health-care professionals are less familiar with PROMs and the interpretation of PROM scores is therefore perceived as challenging. In this paper, we provide insight into the interpretation of PROM scores by introducing the different types and characteristics of PROMs, and the most relevant concepts for the interpretation of PROM scores. Concepts such as minimal detectable change, minimal important change and response shift are explained and illustrated with examples from nephrology care.
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Affiliation(s)
- Esmee M. van der Willik
- Department of Clinical EpidemiologyLeiden University Medical CenterLeidenThe Netherlands
- Department of Epidemiology and Data ScienceAmsterdam UMC, Vrije Universiteit AmsterdamAmsterdamThe Netherlands
| | - Caroline B. Terwee
- Department of Epidemiology and Data ScienceAmsterdam UMC, Vrije Universiteit AmsterdamAmsterdamThe Netherlands
| | - Willem Jan W. Bos
- Department of Internal MedicineLeiden University Medical CenterLeidenThe Netherlands
- Department of Internal MedicineSt. Antonius HospitalNieuwegeinThe Netherlands
| | - Marc H. Hemmelder
- Department of Internal MedicineMaastricht University Medical CenterMaastrichtThe Netherlands
| | - Kitty J. Jager
- ERA‐EDTA Registry, Department of Medical InformaticsAmsterdam UMC, Amsterdam Public Health Research InstituteAmsterdamThe Netherlands
| | - Carmine Zoccali
- CNR‐IFC, Clinical Epidemiology and Physiopathology of Renal Diseases and HypertensionReggio CalabriaItaly
| | - Friedo W. Dekker
- Department of Clinical EpidemiologyLeiden University Medical CenterLeidenThe Netherlands
| | - Yvette Meuleman
- Department of Clinical EpidemiologyLeiden University Medical CenterLeidenThe Netherlands
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