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Daryoush JR, Rogers MJ, Zhang C, Quesada MJ, Cizik AM, Presson AP, Kazmers NH. Developing Linkages Between PROMIS Physical Function CAT and QuickDASH Scores in Hand Surgery: A Crosswalk Study. J Bone Joint Surg Am 2025; 107:614-620. [PMID: 39729527 DOI: 10.2106/jbjs.23.01400] [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: 12/29/2024]
Abstract
BACKGROUND There is no standardization within hand and upper-extremity surgery regarding which patient-reported outcome measures (PROMs) are collected and reported. This limits the ability to compare or combine cohorts that utilize different PROMs. The aim of this study was to develop a linkage model for the QuickDASH (shortened version of the Disabilities of the Arm, Shoulder and Hand) and PROMIS PF CAT (Patient-Reported Outcomes Measurement Information System Physical Function computerized adaptive testing) instruments to allow interconversion between these PROMs in a hand surgery population. METHODS A retrospective review was conducted to identify adults (≥18 years old) who had completed the QuickDASH and PROMIS PF CAT instruments at the same clinical encounter. Patients with shoulder pathology were excluded. The linear relationship between scores was evaluated with use of the Pearson correlation coefficient. Linking was performed with use of several common methods, and an optimal linkage model was recommended on the basis of a higher R 2 , strong intraclass correlation coefficient (ICC), and lower standard error (SE). The recommended model was further evaluated in subgroups based on age (<60 or ≥60 years), sex, etiology for presentation (traumatic versus atraumatic), and treatment type (operative versus nonoperative). RESULTS A total of 15,019 patients (mean age, 49 years; 54% female; 86% White) were included. The mean QuickDASH score (and standard deviation) was 37 ± 22, and the mean PROMIS PF CAT score was 45 ± 10. There was a strong negative linear relationship between the QuickDASH and PROMIS PF CAT (r = -0.73). The circle-arc linkage model demonstrated good accuracy and reliability (R 2 = 0.55; ICC = 0.71), and crosswalk tables were developed from this model. The subgroup analysis demonstrated age-related bias in the linkage model (root expected mean squared difference, 0.12). To address this, a separate crosswalk table was developed, which was dichotomized by age category. CONCLUSIONS The QuickDASH and PROMIS PF CAT scores were successfully linked. Utilization of the developed crosswalks-one specific to patients <60 years old and another specific to patients ≥60 years old-will allow for score interconversion in future meta-analyses and multicenter hand surgery studies. LEVEL OF EVIDENCE Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.
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Affiliation(s)
- Joshua R Daryoush
- Department of Orthopaedic Surgery, University of Utah, Salt Lake City, Utah
| | - Miranda J Rogers
- Department of Orthopaedic Surgery, University of Utah, Salt Lake City, Utah
- Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, Michigan
| | - Chong Zhang
- Division of Public Health, University of Utah, Salt Lake City, Utah
| | - Mario J Quesada
- Department of Orthopaedic Surgery, University of Utah, Salt Lake City, Utah
| | - Amy M Cizik
- Department of Orthopaedic Surgery, University of Utah, Salt Lake City, Utah
| | - Angela P Presson
- Division of Public Health, University of Utah, Salt Lake City, Utah
| | - Nikolas H Kazmers
- Department of Orthopaedic Surgery, University of Utah, Salt Lake City, Utah
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Holeman TA, Hales J, Cizik AM, Zickmund S, Kean J, Brooke BS. Factors that impact the implementation of patient reported outcomes in routine clinical care for peripheral artery disease from the patient perspective. Qual Life Res 2025; 34:711-723. [PMID: 39579272 DOI: 10.1007/s11136-024-03842-6] [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] [Accepted: 11/08/2024] [Indexed: 11/25/2024]
Abstract
PURPOSE Patient reported outcome measures (PROMs) are well-suited for the longitudinal assessment of quality of life, including depression and physical limitations associated with peripheral artery disease (PAD) that are not routinely assessed in clinical care. This study was designed to gain the patient perspective to facilitate implementation of PROMs into clinical practice for PAD management. METHODS Twenty-three patients with PAD at a single vascular surgery clinic were enrolled for a qualitative interview, July-December 2022. Patients completed PROMIS Physical Function and Depression assessments before undergoing semi-structured interviews. Two researchers used an inductive thematic analysis to analyze emergent themes from transcribed interviews. RESULTS The average age of participants was 69.5 ± 8.2 years; 91% were Caucasian, and 39% were female. Qualitative interviews revealed three implementation-related themes: (1) patient preferences on the timing and type of PROMs collected, (2) PROMs applications in outpatient PAD care, including discussions with their physician, and (3) the clinical value of PROMs. Overall, patients with PAD prefer PROMs related to quality of life and physical function over other domains. Patients appreciate the convenience to complete PROMs before their appointment. Patients would like to verbally discuss meaningful score changes with their providers without the use of graphical aids. Most patients believe PROMs are valuable in their clinical care if their physician reviews the results and the PROM questions apply to their disease symptoms. CONCLUSIONS Patient preferences inform future successful implementations and will improve patient completion rates for the collection and clinical use of PROMs in PAD clinical care.
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Affiliation(s)
- Teryn A Holeman
- Division of Vascular Surgery, Department of Population Health Science, University of Utah School of Medicine, 30 N Mario Capecchi Dr., Salt Lake City, UT, 84112, USA.
- Department of Population Health Science, School of Medicine, University of Utah, Salt Lake City, UT, USA.
| | - Julie Hales
- Division of Vascular Surgery, Department of Population Health Science, University of Utah School of Medicine, 30 N Mario Capecchi Dr., Salt Lake City, UT, 84112, USA
| | - Amy M Cizik
- Department of Population Health Science, School of Medicine, University of Utah, Salt Lake City, UT, USA
- Department of Orthopaedic Surgery, School of Medicine, University of Utah, Salt Lake City, UT, USA
| | - Susan Zickmund
- Department of Population Health Science, School of Medicine, University of Utah, Salt Lake City, UT, USA
- Department of Internal Medicine, School of Medicine, University of Utah, Salt Lake City, UT, USA
| | - Jacob Kean
- Department of Population Health Science, School of Medicine, University of Utah, Salt Lake City, UT, USA
- Department of Internal Medicine, School of Medicine, University of Utah, Salt Lake City, UT, USA
| | - Benjamin S Brooke
- Division of Vascular Surgery, Department of Population Health Science, University of Utah School of Medicine, 30 N Mario Capecchi Dr., Salt Lake City, UT, 84112, USA.
- Department of Population Health Science, School of Medicine, University of Utah, Salt Lake City, UT, USA.
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Richards JC, Bachman SL, Leonard-Corzo K, Aryal S, Blankenship JM, Clay I, Lyden K. A Holistic Approach to the Measurement of Physical Function in Clinical Research. Digit Biomark 2025; 9:1-9. [PMID: 39758435 PMCID: PMC11698515 DOI: 10.1159/000542364] [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: 08/19/2024] [Accepted: 10/28/2024] [Indexed: 01/07/2025] Open
Abstract
Background This commentary highlights the evolution of our understanding of physical function (PF) and key models/frameworks that have contributed to the current holistic understanding of PF, which encompasses not only a person's performance but also the environment and any adaptations an individual utilizes. This commentary also addresses how digital health tools can facilitate and complement the assessment of holistic PF and enable both objective and subjective input from the participant in their real-world environment. Lastly, we discuss how successful implementation of digital tools within clinical research requires patient input. Summary This commentary highlights how our understanding of PF has evolved to be more holistic. Key Messages Inclusion of digital tools within clinical research can provide a path forward to holistically assess PF in a patient-focused manner.
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Jaworski EM, Sanderson DJ, Gevelinger M, Doyle PJ. Changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) scores following sacral neuromodulation for lower urinary tract symptoms. Curr Urol 2024; 18:318-322. [PMID: 40256288 PMCID: PMC12004958 DOI: 10.1097/cu9.0000000000000101] [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: 03/31/2020] [Accepted: 05/05/2020] [Indexed: 11/26/2022] Open
Abstract
Background Sacral neuromodulation (SNM) treatment of refractory urinary symptoms is associated with quality of life improvements using disease-specific instruments. There is a paucity of information relating universal health outcomes to effective treatment of urinary symptoms. The objective was to analyze changes in Patient-Reported Outcomes Measurement Information System (PROMIS) item-bank scores following SNM for treating refractory lower urinary tract symptoms (LUTS). Materials and methods This is a sub-analysis collected from an institutional review board approved, retrospective chart review evaluating changes between pre- and post-procedure PROMIS scores in subjects undergoing successful SNM implantation for refractory LUTS at a multidisciplinary adult continence clinic. The difference between pre- and post-procedure PROMIS scores was compared via two-sided Wilcoxon signed-rank test, with p <0.05 considered statistically significant. Results Of the 29 subjects, most were female (89.66%), Caucasian (68.97%), nonsmokers (89.66%) with public insurance (62.07%). The median age was 63years and body mass index was 33.2kg/m2. Procedure indications included urinary urge incontinence (83%), mixed urinary incontinence (10%), retention (17.24%), and overactive bladder (3%). Pain Interference and Depression scores had a nonsignificant improvement from 64.2 (ranging 58.9-67.5) to 60.75 (ranging 55.2-67.2), p = 0.21, and 55.2 (ranging 51.5-59.9) to 53.4 (ranging 49.5-61.1), p = 0.33, respectively. Median Physical Function scores demonstrated nonsignificant worsening following implantation from 38.0 (ranging 34.7-40.9) to 36.1 (ranging 33.1-40.8) (p = 0.25). Twenty-one subjects (72%) reported an improvement in at least 1 PROMIS item-bank with 6 subjects (21%) reporting no improvement in any of the item-banks. Conclusions Treatment of refractory LUTS with SNM resulted in no statistically significant changes in the PROMIS item-banks of Physical Function, Pain Interference, or Depression. Further prospective investigation is necessary to delineate the relationship of the self-reported universal-health outcomes in the treatment of LUTS.
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Affiliation(s)
| | - Derrick J. Sanderson
- Department of Obstetrics and Gynecology, School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA
| | - Matthew Gevelinger
- Department of Obstetrics and Gynecology, School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA
| | - Paula J. Doyle
- Department of Obstetrics and Gynecology, Department of Urology, School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA
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Balachandran AT, Orange ST, Wang Y, Lustin R, Vega A, Quiles N. Comparison of two popular transducers to measure sit-to-stand power in older adults. PLoS One 2024; 19:e0308808. [PMID: 39133754 PMCID: PMC11318872 DOI: 10.1371/journal.pone.0308808] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/08/2024] [Accepted: 07/31/2024] [Indexed: 08/15/2024] Open
Abstract
The Tendo Unit (TU) and GymAware (GA) are the two most frequently used linear transducers for assessing muscle power in older adults via the sit-to-stand (STS) test. Unlike TU, GA incorporates a sensor mechanism to correct for non-vertical movements, which may lead to systematic differences between devices. The aim of this study therefore was to compare GA to TU for measuring STS power in community-dwelling older adults. Community-dwelling adults (n = 51, aged ≥65 years, 61% female) completed a single chair stand, with peak power measured simultaneously using GA and TU. Participants also completed the pneumatic leg press, 8-Foot Up and Go (TUG) test, Short Physical Performance Battery (SPPB), and self-reported measures of physical function. Intraclass correlations (ICC) were used to assess agreement, and Pearson's correlations were used to assess correlations. The study protocol was prospectively registered on the Open Science Framework. In alignment with our pre-registered hypothesis, peak power demonstrated an ICC of 0.93 (95% CI: 0.88, 0.96). For secondary aims, both transducers showed a correlation greater than 0.8 compared to pneumatic leg press power. For physical performance outcomes, both TU and GA showed similar correlations, as hypothesized: SPPB (r = 0.29 for TU vs. 0.33 for GA), Chair Stands (r = -0.41 vs. -0.38), TUG Fast (r = -0.53 vs. -0.52), mobility questionnaire (r = 0.52 vs. 0.52) and physical function questionnaire (r = 0.44 vs. 0.43). GA and TU peak power showed a high degree of agreement and similar correlations with physical and self-reported performance measures, suggesting that both methods can be used for assessing STS power in older adults.
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Affiliation(s)
- Anoop T. Balachandran
- Department of Family, Nutrition and Exercise Sciences, Queens College, New York, NY, United States of America
| | - Samuel T. Orange
- Department of Sport, Exercise and Rehabilitation, Faculty of Health and Life Sciences, Northumbria University, Newcastle Upon Tyne, United Kingdom
| | - Yipeng Wang
- Department of Biostatistics, University of Florida, Gainesville, FL, United States of America
| | - Renee Lustin
- Department of Family, Nutrition and Exercise Sciences, Queens College, New York, NY, United States of America
| | - Andy Vega
- Department of Family, Nutrition and Exercise Sciences, Queens College, New York, NY, United States of America
| | - Norberto Quiles
- Department of Family, Nutrition and Exercise Sciences, Queens College, New York, NY, United States of America
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Holeman TA, Chester C, Hales JB, Zhang Y, Johnson CE, Brooke BS. Long-term patient-reported outcomes among patients undergoing revascularization vs medical therapy for intermittent claudication. J Vasc Surg 2024; 80:466-477.e4. [PMID: 38608965 PMCID: PMC11260535 DOI: 10.1016/j.jvs.2024.03.455] [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: 11/09/2023] [Revised: 02/29/2024] [Accepted: 03/16/2024] [Indexed: 04/14/2024]
Abstract
OBJECTIVE Society for Vascular Surgery guidelines recommend revascularization for patients with intermittent claudication (IC) if it can improve patient function and quality of life. However, it is still unclear if patients with IC achieve a significant functional benefit from surgery compared with medical management alone. This study examines the relationship between IC treatment modality (operative vs nonoperative optimal medical management) and patient-reported outcomes for physical function (PROMIS-PF) and satisfaction in social roles and activities (PROMIS-SA). METHODS We identified patients with IC who presented for index evaluation in a vascular surgery clinic at an academic medical center between 2016 and 2021. Patients were stratified based on whether they underwent a revascularization procedure during follow-up vs continued nonoperative management with medication and recommended exercise therapy. We used linear mixed-effect models to assess the relationship between treatment modality and PROMIS-PF, PROMIS-SA, and ankle-brachial index (ABI) over time, clustering among repeat patient observations. Models were adjusted for age, sex, diabetes, Charlson Comorbidity Index, Clinical Frailty Score, tobacco use, and index ABI. RESULTS A total of 225 patients with IC were identified, of which 40% (n = 89) underwent revascularization procedures (42% bypass; 58% peripheral vascular intervention) and 60% (n = 136) continued nonoperative management. Patients were followed up to 6.9 years, with an average follow-up of 5.2 ± 1.6 years. Patients who underwent revascularization were more likely to be clinically frail (P = .03), have a lower index ABI (0.55 ± 0.24 vs 0.72 ± 0.28; P < .001), and lower baseline PROMIS-PF score (36.72 ± 8.2 vs 40.40 ± 6.73; P = .01). There were no differences in patient demographics or medications between treatment groups. Examining patient-reported outcome trends over time; there were no significant differences in PROMIS-PF between groups, trends over time, or group differences over time after adjusting for covariates (P = .07, P = .13, and P =.08, respectively). However, all patients with IC significantly increased their PROMIS-SA over time (adjusted P = .019), with patients managed nonoperatively more likely to have an improvement in PROMIS-SA over time than those who underwent revascularization (adjusted P = .045). CONCLUSIONS Patient-reported outcomes associated with functional status and satisfaction in activities are similar for patients with IC for up to 7 years, irrespective of whether they undergo treatment with revascularization or continue nonoperative management. These findings support conservative long-term management for patients with IC.
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Affiliation(s)
- Teryn A Holeman
- Division of Vascular Surgery, University of Utah, School of Medicine, Salt Lake City, UT; Department of Population Health Science, University of Utah, School of Medicine, Salt Lake City, UT.
| | - Cassidy Chester
- Division of Vascular Surgery, University of Utah, School of Medicine, Salt Lake City, UT
| | - Julie B Hales
- Division of Vascular Surgery, University of Utah, School of Medicine, Salt Lake City, UT
| | - Yue Zhang
- Department of Population Health Science, University of Utah, School of Medicine, Salt Lake City, UT
| | - Cali E Johnson
- Division of Vascular Surgery, University of Utah, School of Medicine, Salt Lake City, UT
| | - Benjamin S Brooke
- Division of Vascular Surgery, University of Utah, School of Medicine, Salt Lake City, UT; Department of Population Health Science, University of Utah, School of Medicine, Salt Lake City, UT
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Meng CF, Lee YC, Schieir O, Valois MF, Butler MA, Boire G, Hazlewood G, Hitchon C, Keystone E, Tin D, Thorne C, Bessette L, Pope J, Bartlett SJ, Bykerk VP. Having More Tender Than Swollen Joints Is Associated With Worse Patient-Reported Outcomes in Patients With Early RA. J Clin Rheumatol 2024; 30:193-199. [PMID: 38689390 PMCID: PMC11388901 DOI: 10.1097/rhu.0000000000002091] [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] [Indexed: 05/02/2024]
Abstract
BACKGROUND/OBJECTIVE In patients with rheumatoid arthritis (RA), high tender-swollen joint differences (TSJDs) have been associated with worse outcomes. A better understanding of the phenotype and impact of high TSJD on patient-reported outcomes (PROs) in early RA may lead to earlier personalized treatment targeting domains that are important to patients today. Our objectives were to evaluate the impact of TSJD on updated PROs in patients with early RA over 1 year and to determine differences in associations by joint size. METHODS This longitudinal cohort study followed patients with active, early RA enrolled in the Canadian Early Arthritis Cohort between 2016 and 2022, who completed clinical assessments and PROMIS-29 measures over 1 year. Twenty-eight joint counts were performed and TSJDs calculated. Adjusted associations between TSJD and PROMIS-29 scores were estimated using separate linear-mixed models. Separate analyses of large versus small-joint TJSDs were performed. RESULTS Patients with early RA (n = 547; 70% female; mean [SD] age, 56 [15] years; mean [SD] symptom duration, 5.3 [2.9] months) were evaluated. A 1-point increase in TSJD was significantly associated with worse PROMIS T-scores in all domains: physical function (adjusted regression coefficient, -0.27; 95% confidence interval [CI], -0.39, -0.15), social participation (adjusted regression coefficient, -0.34; 95% CI, -0.50, -0.19), pain interference (adjusted regression coefficient, 0.49; 95% CI, 0.35, 0.64), sleep problems (adjusted regression coefficient, 0.29; 95% CI, 0.16, 0.43), fatigue (adjusted regression coefficient, 0.34; 95% CI, 0.18, 0.50), anxiety (adjusted regression coefficient, 0.23; 95% CI, 0.08, 0.38), and depression (adjusted regression coefficient, 0.20; 95% CI, 0.06, 0.35). Large-joint TSJD was associated with markedly worse PROs compared with small-joint TSJD. CONCLUSIONS Elevated TSJD is associated with worse PROs particularly pain interference, social participation, and fatigue. Patients with more tender than swollen joints, especially large joints, may benefit from earlier, targeted therapeutic interventions.
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Affiliation(s)
- Charis F Meng
- From the Hospital for Special Surgery, Division of Rheumatology, Weill Cornell Medical College, New York, NY
| | - Yvonne C Lee
- Northwestern University Feinberg School of Medicine, Medicine/Rheumatology, Chicago, Illinois
| | - Orit Schieir
- University of Toronto, Dalla Lana School of Public Health
| | | | - Margaret A Butler
- Hospital for Special Surgery, Division of Rheumatology, New York, NY
| | - Gilles Boire
- Université de Sherbrooke, Medicine, Quebec, Canada
| | - Glen Hazlewood
- University of Calgary, Department of Medicine, Alberta, Canada
| | - Carol Hitchon
- University of Manitoba, Department of Internal Medicine, Winnipeg, Canada
| | | | - Diane Tin
- University of Toronto, Ontario, Canada
| | - Carter Thorne
- Southlake Regional Health Centre, Centre of Arthritis Excellence, TAP Research Group, Ontario, Canada
| | | | - Janet Pope
- University of Western Ontario, London, Ontario, Canada
| | | | - Vivian P Bykerk
- Hospital for Special Surgery and Mount Sinai Hospital, Weill Cornell Medical College, New York, NY
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Azad CL, Beres LK, Wu AW, Fong A, Giladi AM. Developing a multimedia patient-reported outcomes measure for low literacy patients with a human-centered design approach. PLoS One 2024; 19:e0304351. [PMID: 38838037 DOI: 10.1371/journal.pone.0304351] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2023] [Accepted: 05/10/2024] [Indexed: 06/07/2024] Open
Abstract
INTRODUCTION Almost all patient-reported outcomes measures (PROMs) are text-based, which impedes accurate completion by low and limited literacy patients. Few PROMs are designed or validated to be self-administered, either in clinical or research settings, by patients of all literacy levels. We aimed to adapt the Patient Reported Outcomes Measurement Information System Upper Extremity Short Form (PROMIS-UE) to a multimedia version (mPROMIS-UE) that can be self-administered by hand and upper extremity patients of all literacy levels. METHODS Our study in which we applied the Multimedia Adaptation Protocol included seven phases completed in a serial, iterative fashion: planning with our community advisory board; direct observation; discovery interviews with patients, caregivers, and clinic staff; ideation; prototyping; member-checking interviews; and feedback. Direct observations were documented in memos that underwent rapid thematic analysis. Interviews were audio-recorded and documented using analytic memos; a rapid, framework-guided thematic analysis with both inductive and deductive themes was performed. Themes were distilled into design challenges to guide ideation and prototyping that involved our multidisciplinary research team. To assess completeness, credibility, and acceptability we completed additional interviews with member-checking of initial findings and consulted our community advisory board. RESULTS We conducted 12 hours of observations. We interviewed 17 adult English-speaking participants (12 patients, 3 caregivers, 2 staff) of mixed literacy. Our interviews revealed two distinct user personas and three distinct literacy personas; we developed the mPROMIS-UE with these personas in mind. Themes from interviews were distilled into four broad design challenges surrounding literacy, customizability, convenience, and shame. We identified features (audio, animations, icons, avatars, progress indicator, illustrated response scale) that addressed the design challenges. The last 6 interviews included member-checking; participants felt that the themes, design challenges, and corresponding features resonated with them. These features were synthesized into an mPROMIS-UE prototype that underwent rounds of iterative refinement, the last of which was guided by recommendations from our community advisory board. DISCUSSION We successfully adapted the PROMIS-UE to an mPROMIS-UE that addresses the challenges identified by a mixed literacy hand and upper extremity patient cohort. This demonstrates the feasibility of adapting PROMs to multimedia versions. Future research will include back adaptation, usability testing via qualitative evaluation, and psychometric validation of the mPROMIS-UE. A validated mPROMIS-UE will expand clinicians' and investigators' ability to capture patient-reported outcomes in mixed literacy populations.
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Affiliation(s)
- Chao Long Azad
- The Curtis National Hand Center, MedStar Union Memorial Hospital, Baltimore, Maryland, United States of America
- Department of Plastic and Reconstructive Surgery, Johns Hopkins Medicine, Baltimore, Maryland, United States of America
| | - Laura K Beres
- Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
| | - Albert W Wu
- Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
| | - Allan Fong
- MedStar Health Research Institute, Hyattsville, Maryland, United States of America
| | - Aviram M Giladi
- The Curtis National Hand Center, MedStar Union Memorial Hospital, Baltimore, Maryland, United States of America
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Rogers MJ, Daryoush JR, Zhang C, Cizik A, Presson AP, Kazmers NH. Crosswalk between the PROMIS physical function CAT and PROMIS upper extremity CAT v1.2 in a hand surgery population. J Patient Rep Outcomes 2024; 8:53. [PMID: 38816587 PMCID: PMC11139816 DOI: 10.1186/s41687-024-00736-6] [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: 12/11/2023] [Accepted: 05/20/2024] [Indexed: 06/01/2024] Open
Abstract
BACKGROUND There is no gold standard patient-reported outcome measure (PROM) in hand surgery. As a result, a diverse array of PROM instruments have been utilized across centers over time. Lack of score interchangeability limits the ability to compare or conglomerate scores when new instruments are introduced. Our aim was to develop a linkage for the PROMIS UE CAT v1.2 and PROMIS PF CAT scores and develop crosswalk tables for interconversion between these PROMs. METHODS Retrospective review was conducted to identify adult (≥ 18y) patients seen by orthopaedic hand surgeons at a single academic tertiary care hospital who had completed PROMIS UE CAT v1.2 and PROMIS PF CAT score at the same visit. For those with multiple visits, only one randomly selected visit was included in the analyses. Pearson's correlation was calculated to determine the linear relationship between the scores. Linkage from PF to UE was performed utilizing several commonly utilized equating models (identity, mean, linear, equipercentile and circle-arc methods). The performance of the models was assessed using intraclass correlation (ICC) between observed PROMIS UE CAT v1.2 and estimated PROMIS UE CAT v1.2 scores generated using the model as well as Root Mean Square Error (RMSE). The model chosen as the 'best' was further assessed for population invariance using root expected mean squared difference (REMSD) where < 0.08 were considered good. RESULTS Of 10,081 included patients, mean age was 48.3 (SD = 17.0), and 54% were female (5,477/10,081). Mean UE CAT v1.2 and PF CAT scores were 37 (SD = 9.8) and 46 (SD = 10.0), respectively. There was a strong correlation between the scores (Pearson correlation r = 0.70). All methods performed acceptably (ICC ≥ 0.66 and RMSE < = 7.52 for all). The equipercentile method had the highest ICC (ICC = 0.70 (95% CI 0.69-0.71)) while the mean and circle arc methods had the lowest RMSE. The circle arc method is the most reliable with the smallest standard error and has satisfactory population invariance across age group (REMSD 0.065) and sex (REMSD 0.036). CONCLUSIONS Crosswalk tables to be used for bidirectional conversion between scores were created. LEVEL OF EVIDENCE III.
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Affiliation(s)
- Miranda J Rogers
- Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI, 48109, USA
- Department of Orthopaedic Surgery, University of Utah, 590 Wakara Way, Salt Lake City, UT, 84108, USA
| | - Joshua R Daryoush
- Department of Orthopaedic Surgery, University of Utah, 590 Wakara Way, Salt Lake City, UT, 84108, USA
| | - Chong Zhang
- Division of Public Health, University of Utah, Salt Lake City, UT, 84108, USA
| | - Amy Cizik
- Department of Orthopaedic Surgery, University of Utah, 590 Wakara Way, Salt Lake City, UT, 84108, USA
| | - Angela P Presson
- Division of Public Health, University of Utah, Salt Lake City, UT, 84108, USA
| | - Nikolas H Kazmers
- Department of Orthopaedic Surgery, University of Utah, 590 Wakara Way, Salt Lake City, UT, 84108, USA.
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Nelson AE. Multiple joint osteoarthritis (MJOA): What's in a name? Osteoarthritis Cartilage 2024; 32:234-240. [PMID: 37984559 PMCID: PMC10922529 DOI: 10.1016/j.joca.2023.10.008] [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] [Received: 07/31/2023] [Revised: 09/13/2023] [Accepted: 10/26/2023] [Indexed: 11/22/2023]
Abstract
OBJECTIVE To summarize the current state of the literature regarding multi-joint osteoarthritis (MJOA) and discuss important future directions. DESIGN A narrative review of the author's work and other key references on this topic with a focus on the Johnston County studies, definitions of MJOA and their impact, multi-site pain in osteoarthritis (OA), genetics and biomarkers in MJOA, and perspectives on future work. RESULTS MJOA is variably defined and lacks a clear consensus definition, making comprehensive study challenging. Involvement of both symptoms and structural changes of OA in multiple joints in an individual is common, but patterns vary by sex, race/ethnicity, and other factors. Outcomes (e.g., general health, function, falls, mortality) are negatively impacted by a greater whole-body OA burden. Recent genetic and biomarker studies including whole-body OA assessments have begun to shed some light on potentially unique factors in the MJOA population. CONCLUSIONS Consideration of MJOA is essential for ongoing study of OA phenotypes, epidemiology, risk factors, genetics, biomarkers, and outcomes, to fully understand and eventually limit the negative impact of OA burden on health.
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Affiliation(s)
- Amanda E Nelson
- Department of Medicine, Division of Rheumatology, Allergy, and Immunology, Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
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11
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Staggs H, Mills-Finnerty C. Protocol optimization and reducing dropout in online research. Front Hum Neurosci 2023; 17:1251174. [PMID: 38116233 PMCID: PMC10729001 DOI: 10.3389/fnhum.2023.1251174] [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: 07/01/2023] [Accepted: 10/12/2023] [Indexed: 12/21/2023] Open
Abstract
Online research has advantages over in-person research; it's cost-efficient, scalable, and may increase diversity. Researchers collecting data online can assess protocol performance with classification models like a decision tree. However, challenges include attrition, lack of testing environment controls, technical limitations, and lack of face-to-face rapport and real time feedback. It is necessary to consider human factors of the teleresearch process from recruitment to data collection. Here we document the impact of protocol optimizations on social media engagement and retention between a pilot sample of Veterans (n = 26) and a post-optimization sample of both Veterans and civilians (n = 220) recruited from Facebook advertisements. Two-sided tests for equality of proportions were statistically significant: advertisement views leading to clicks increased by 23.8% [X2(1) = 130.3, p < 0.001] and completion of behavioral tasks increased by 31.2% [X2(1) = 20.74, p < 0.001]. However, a proportion of participants dropped out of the study before completion for both samples. To explore why, a C5.0 decision tree was used to find features that classify participant dropout. The features chosen by the algorithm were nicotine use (100%) and cannabis use (25.6%). However, for those completing the study, data quality of cognitive performance was similar for users and nonusers. Rather than determining eligibility, participants who endorse using nicotine, or both nicotine and cannabis, may have individual differences that require support in online protocols to reduce drop out, such as extra breaks. An introduction page that humanizes participants' lifestyle habits as a naturalistic benefit of remote research may also be helpful. Strategies are discussed to increase engagement and improve data quality. The findings have implications for the feasibility of conducting remote research, an increasingly popular approach that has distinct challenges compared to in-person studies.
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Affiliation(s)
- Halee Staggs
- Mental Illness Research Education and Clinical Center, VA Palo Alto Health Care System, Palo Alto, CA, United States
- Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, United States
- Shiley-Marcos School of Engineering, University of San Diego, San Diego, CA, United States
| | - Colleen Mills-Finnerty
- Mental Illness Research Education and Clinical Center, VA Palo Alto Health Care System, Palo Alto, CA, United States
- Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, United States
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12
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Terwee CB, Roorda LD. Country-specific reference values for PROMIS ® pain, physical function and participation measures compared to US reference values. Ann Med 2023; 55:1-11. [PMID: 36426680 PMCID: PMC9704075 DOI: 10.1080/07853890.2022.2149849] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/27/2022] Open
Abstract
INTRODUCTION Patient-Reported Outcomes Measurement Information System (PROMIS®) is commonly used across medical conditions. To facilitate interpretation of scores across countries, we calculated Dutch reference values for PROMIS Physical Function (PROMIS-PF), Pain Interference (PROMIS-PI), Pain Behavior (PROMIS-PB), Ability to Participate in Social Roles and Activities (PROMIS-APSRA), and Satisfaction with Social Roles and Activities (PROMIS-SSRA), as compared to US reference values. PATIENTS AND METHODS A panel completed full PROMIS-PF (n=1310), PROMIS-PI and PROMIS-PB (n=1052), and PROMIS-APSRA and PROMIS-SSRA (n=1002) item banks and reported their level of health per domain (no, mild, moderate, severe limitations). T-scores were calculated by sample and subgroups (age, gender, self-reported level of domain). Distribution-based and anchor-based thresholds for mild, moderate, and severe scores were determined. RESULTS Mean T-scores were close to the US mean of 50 for PROMIS-PF (49.8) and PROMIS-APSRA (50.6), lower for PROMIS-SSRA (47.5) and higher for PROMIS-PI (54.9) and PROMIS-PB (52.0). Distribution-based thresholds for mild, moderate, and severe scores were comparable to US recommended cut-off values (except for PROMIS-PI) but participants reported limitations 'earlier' than suggested thresholds. CONCLUSION Dutch reference values were close to US reference values for some PROMIS domains but not all. We recommend country-specific reference values to facilitate worldwide PROMIS use.KEY MESSAGESPROMIS offers universally applicable IRT-based efficient and patient-friendly measures to assess commonly relevant patient-reported outcomes across medical conditions.To support the use of PROMIS in daily clinical practice and research across the world, country-specific general population reference values should be obtained.More research is necessary to obtain reliable and valid cut-off values for what constitutes mild, moderate and severe scores from the patients' perspective.
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Affiliation(s)
- Caroline B Terwee
- Department of Epidemiology and Data Science, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.,Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
| | - Leo D Roorda
- Amsterdam Rehabilitation Research Center
- Reade, Amsterdam, The Netherlands
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Teuwen MMH, Knaapen IRE, Vliet Vlieland TPM, Schoones JW, van den Ende CHM, van Weely SFE, Gademan MGJ. The use of PROMIS measures in clinical studies in patients with inflammatory arthritis: a systematic review. Qual Life Res 2023; 32:2731-2749. [PMID: 37103773 PMCID: PMC10474175 DOI: 10.1007/s11136-023-03422-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/11/2023] [Indexed: 04/28/2023]
Abstract
PURPOSE Although the use of Patient-Reported Outcomes Measurement Information System (PROMIS) measures is widely advocated, little is known on their use in patients with inflammatory arthritis. We systematically describe the use and outcomes of PROMIS measures in clinical studies involving people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). METHODS A systematic review was conducted according to the PRISMA guidelines. Through a systematic search of nine electronic databases, clinical studies including patients with RA or axSpA and reporting the use of PROMIS measure were selected. Study characteristics, details of PROMIS measures and their outcomes, if available, were extracted. RESULTS In total, 29 studies described in 40 articles met the inclusion criteria, of which 25 studies included RA patients, three studies included axSpA patients and one study included both RA and axSpA patients. The use of two general PROMIS measures (PROMIS Global Health, PROMIS-29) and 13 different domain-specific PROMIS measures was reported, of which the PROMIS Pain Interference (n = 17), Physical Function (n = 14), Fatigue (n = 13), and Depression (n = 12) measures were most frequently used. Twenty-one studies reported their results in terms of T-scores. Most T-scores were worse than the general population mean, indicating impairments of health status. Eight studies did not report actual data but rather measurement properties of the PROMIS measures. CONCLUSION There was considerable variety regarding the different PROMIS measures used, with the PROMIS Pain interference, Physical function, Fatigue, and Depression measures being the most frequently used. In order to facilitate the comparisons across studies, more standardization of the selection of PROMIS measures is needed.
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Affiliation(s)
- M M H Teuwen
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center (LUMC), Albinusdreef 2, P.O.Box 9600, 2300 RC, Leiden, The Netherlands.
| | - I R E Knaapen
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center (LUMC), Albinusdreef 2, P.O.Box 9600, 2300 RC, Leiden, The Netherlands
| | - T P M Vliet Vlieland
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center (LUMC), Albinusdreef 2, P.O.Box 9600, 2300 RC, Leiden, The Netherlands
| | - J W Schoones
- Directorate of Research Policy, Leiden University Medical Center, Leiden, The Netherlands
| | - C H M van den Ende
- Department of Research, Sint Maartenskliniek, Nijmegen, The Netherlands
- Department of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands
| | - S F E van Weely
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center (LUMC), Albinusdreef 2, P.O.Box 9600, 2300 RC, Leiden, The Netherlands
| | - M G J Gademan
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center (LUMC), Albinusdreef 2, P.O.Box 9600, 2300 RC, Leiden, The Netherlands
- Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands
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Klapproth CP, Fischer F, Rose M. Scale agreement, ceiling and floor effects, construct validity, and relative efficiency of the PROPr and EQ-5D-3L in low back pain patients. Health Qual Life Outcomes 2023; 21:107. [PMID: 37759272 PMCID: PMC10523622 DOI: 10.1186/s12955-023-02188-w] [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: 02/10/2023] [Accepted: 09/08/2023] [Indexed: 09/29/2023] Open
Abstract
BACKGROUND The PROMIS Preference score (PROPr) is a new health state utility (HSU) score that aims to comprehensively incorporate the biopsychosocial model of health and apply favorable psychometric properties from the descriptive PROMIS system to HSU measurements. However, minimal evidence concerning comparisons to the EQ-5D-3L and the PROPr's capability to differentiate clinical severity are available. Therefore, the aim of this study was to compare the PROPr to the EQ-5D-3L in terms of scale agreement, ceiling/floor effects, distribution, construct validity, discriminatory power, and relative efficiency (RE) in terms of the Oswestry Disability Index (ODI) for patients with low back pain (LBP). METHODS We used intra-class correlation coefficients (ICC) and Bland-Altman plots to compare the PROPr and EQ-5D-3L with regared to scale agreement in a cross-sectional routine sample of LBP patients. For distribution, we used the Pearson's coefficient for skewness and for ceiling/floor effects, a 15%-top/bottom threshold. For convergent validity, we used Pearson's correlation coefficients. For known-groups validity, we applied a linear regression with interaction terms (predictors sex, age, and ODI level) and an analysis of variance (ANOVA). For discriminatory power, we calculated the effect size (ES) using Cohen's d and the ratio of the area under the receiver-operating characteristics curves (AUROC-ratio = AUROCPROPr/AUROCEQ-5D-3L). RE was measured using the ratio of F-values (RE = FPROPr/FEQ-5D-3L). RESULTS Of 218 LBP patients, 50.0% were female and the mean age was 61.8 years. The mean PROPr (0.20, 95%CI: 0.18; 0.22) and EQ-5D-3L scores (0.55, 95%CI: 0.51; 0.58) showed low agreement (d = 0.35, p < 0.001; ICC 0.27, 95%CI: -0.09; 0.59). The PROPr's distribution was positively skewed, whereas the EQ-5D-3L's was negative. Neither tool showed ceiling/floor effects, but all EQ-5D-3L dimensions did. Pearson correlation was r = 0.66 (95%CI: 0.58; 0.73). Differences were invariant to sex and age but not to ODI severity: ESEQ-5D-3L > ESPROPr and RE < 1 in higher ODI severity; ESEQ-5D-3L < ESPROPr and RE > 1 in lower ODI severity. AUROC-ratios did not show significant differences in terms of ODI severity. CONCLUSIONS All PROPr and EQ-5D-3L biopsychosocial dimensions of health showed impairment in LPB patients. The capability of EQ-5D-3L and PROPr to differentiate ODI levels depends on ODI severity. Joint application of both tools may provide additional information.
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Affiliation(s)
- Christoph Paul Klapproth
- Center for Patient-Centered Outcomes Research (CPCOR), Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
| | - Felix Fischer
- Center for Patient-Centered Outcomes Research (CPCOR), Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, Berlin, Germany
| | - Matthias Rose
- Center for Patient-Centered Outcomes Research (CPCOR), Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, Berlin, Germany
- Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA
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Bigford GE, Betancourt LF, Charlifue S, Nash MS. Therapeutic Lifestyle Intervention Targeting Enhanced Cardiometabolic Health and Function for Persons with Chronic Spinal Cord Injury in Caregiver/Care-Receiver Co-Treatment: A Study Protocol of a Multisite Randomized Controlled Trial. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2023; 20:6819. [PMID: 37835090 PMCID: PMC10572441 DOI: 10.3390/ijerph20196819] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/25/2023] [Revised: 09/13/2023] [Accepted: 09/19/2023] [Indexed: 10/15/2023]
Abstract
BACKGROUND Chronic spinal cord injury (SCI) significantly accelerates morbidity and mortality, partly due to the increased risk of cardiometabolic diseases (CMD), including neurogenic obesity, dyslipidemia, and impaired glucose metabolism. While exercise and dietary interventions have shown some transient benefits in reducing CMD risk, they often fail to improve clinically relevant disease markers and cardiovascular events. Moreover, SCI also places caregiving demands on their caregivers, who themselves experience health and functional decline. This underscores the need for more substantial interventions that incorporate appropriate physical activity, heart-healthy nutrition, and behavioral support tailored to the SCI population. OBJECTIVES This randomized clinical trial (RCT) protocol will (1) assess the health and functional effects, user acceptance, and satisfaction of a 6-month comprehensive therapeutic lifestyle intervention (TLI) adapted from the National Diabetes Prevention Program (DPP) for individuals with chronic SCI and (2) examine the impact of a complementary caregiver program on the health and function of SCI caregivers and evaluate user acceptance and satisfaction. Caregivers (linked with their partners) will be randomized to 'behavioral support' or 'control condition'. METHODS Dyadic couples comprise individuals with SCI (18-65 years, >1-year post-injury, ASIA Impairment Scale A-C, injury levels C5-L1) and non-disabled SCI caregivers (18-65 years). Both groups undergo lock-step circuit resistance training, a calorie-restricted Mediterranean-style diet, and 16 educational sessions focused on diet/exercise goals, self-monitoring, psychological and social challenges, cognitive behavioral therapy, and motivational interviewing. The outcome measures encompass the cardiometabolic risks, cardiorespiratory fitness, inflammatory stress, multidimensional function, pain, life quality, independence, self-efficacy, program acceptance, and life satisfaction for SCI participants. The caregiver outcomes include multidimensional function, pain, quality of life, independence, and perceived caregiver burden. DISCUSSION/CONCLUSIONS This study evaluates the effects and durability of a structured, multi-modal intervention on health and function. The results and intervention material will be disseminated to professionals and consumers for broader implementation. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT02853149 Registered 2 August 2016.
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Affiliation(s)
- Gregory E. Bigford
- Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, FL 33136, USA; (L.F.B.); (M.S.N.)
| | - Luisa F. Betancourt
- Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, FL 33136, USA; (L.F.B.); (M.S.N.)
| | | | - Mark S. Nash
- Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, FL 33136, USA; (L.F.B.); (M.S.N.)
- Department of Physical Medicine & Rehabilitation, University of Miami Miller School of Medicine, Miami, FL 33101, USA
- Department of Physical Therapy, University of Miami Miller School of Medicine, Miami, FL 33136, USA
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16
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T Balachandran A, Wang Y, Szabo F, Watts-Battey C, Schoenfeld BJ, Zenko Z, Quiles N. Comparison of traditional vs. lighter load strength training on fat-free mass, strength, power and affective responses in middle and older-aged adults: A pilot randomized trial. Exp Gerontol 2023; 178:112219. [PMID: 37236327 DOI: 10.1016/j.exger.2023.112219] [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: 04/10/2023] [Revised: 05/15/2023] [Accepted: 05/22/2023] [Indexed: 05/28/2023]
Abstract
OBJECTIVES Strength training is widely recommended to improve strength, muscle mass and power. However, the feasibility and potential efficacy of strength training using lighter loads near failure on these outcomes in middle and older-aged adults remains unclear. METHODS 23 community-living adults were randomized into two groups: Traditional strength training (ST) (8-12 repetitions) or a lighter load, higher repetitions (LLHR) (20-24 repetitions) group. Participants performed a full-body workout (twice a week) with 8 exercises at a perceived exertion of 7-8 (0-10 scale) for 10 weeks. Post-testing was performed by an assessor blinded to group assignments. An analysis of covariance (ANCOVA) was used to examine between group differences using baseline values as a covariate. RESULTS The study involved individuals with a mean age of 59 years, of which 61 % were women. The LLHR group demonstrated a high attendance rate of 92 % (9.5 %) and reported leg press exercise RPE of 7.1 (0.53), along with a session feeling scale of 2.0 (1.7). There was a trivial difference in fat free mass (FFM) favoring LLHR vs ST [0.27 kg 95 % CI (-0.87, 1.42)]. The ST group exhibited superior increases in leg press 1 repetition maximum (1RM) strength [-14 kg (-23, -5)], while the LLHR group showed greater strength endurance increases (65 % 1RM) [8 repetitions (2, 14)]. Leg press power [41 W (-42, 124)] and exercise efficacy [-3.8 (-21.2, 13.5)] demonstrated trivial between-group differences. CONCLUSION A pragmatic, full-body strength training program with lighter loads taken close to failure appears to be a viable option for promoting muscular adaptations in middle- and older-aged adults. These results are exploratory and require a larger trial for confirmation.
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Affiliation(s)
- Anoop T Balachandran
- Department of Family, Nutrition, and Exercise Sciences, Queens College, The City University of New York, Flushing, NY, USA.
| | - Yipeng Wang
- Department of Biostatistics, University of Florida, Gainesville, USA
| | - Frank Szabo
- Department of Family, Nutrition, and Exercise Sciences, Queens College, The City University of New York, Flushing, NY, USA
| | - Catharyn Watts-Battey
- Department of Family, Nutrition, and Exercise Sciences, Queens College, The City University of New York, Flushing, NY, USA
| | - Brad J Schoenfeld
- Department of Exercise Science and Recreation, CUNY Lehman College, Bronx, NY, USA
| | - Zachary Zenko
- California State University Bakersfield, Department of Kinesiology, Bakersfield, CA, USA
| | - Norberto Quiles
- Department of Family, Nutrition, and Exercise Sciences, Queens College, The City University of New York, Flushing, NY, USA
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Ho EH, Verkuilen J, Fischer F. Measuring individual true change with PROMIS using IRT-based plausible values. Qual Life Res 2023; 32:1369-1379. [PMID: 36282446 PMCID: PMC10849110 DOI: 10.1007/s11136-022-03264-2] [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] [Accepted: 09/29/2022] [Indexed: 10/31/2022]
Abstract
AIMS A primary advantage of IRT-based patient-reported outcome measures such as PROMIS short forms and computer-adaptive tests is that each estimate of the latent trait comes with a standard error. Such measurement error needs to be acknowledged, in particular when monitoring individual patients over time. In this study, we use plausible values to account for measurement error and analyze the probability of true within-individual change. METHODS We use a longitudinal, observational study of stable and exacerbated COPD patients (N = 185), providing PROMIS Physical Function and Fatigue T-scores over 3 months. At each measurement, we imputed 1000 plausible values from the scores' posterior distribution. These were then used to calculate probability of true change using a pre-specified threshold such as minimally important difference supported by the literature, or [Formula: see text] > 0. We demonstrate assessment of change in individuals and in groups, across different measures (Short Forms and CATs), and at various levels of confidence. RESULTS Using plausible value imputation and with 95% certainty, 47.5% of participants in the exacerbated group reported less fatigue, compared with 26.5% of participants in the stable group. Comparison of Short Forms and CATs suggests that CATs have better ability to detect change compared to short forms. We also illustrate this method using an individual's probability of change at different time points. CONCLUSION Plausible values offer a flexible way to include measurement error in analysis of individuals and on sample level. Assessment of probability of true change can complement existing distribution-based approaches and facilitates interpretation of improvement or decline.
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Affiliation(s)
- Emily H Ho
- Feinberg School of Medicine, Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA.
| | - Jay Verkuilen
- Graduate Center, Ph.D. Program in Educational Psychology, City University of New York, New York, NY, USA
| | - Felix Fischer
- Charité-Universitätsmedizin Berlin, Department for Psychosomatic, Corporate member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Berlin, Germany
- Berlin Institute of Health at Charité-Universitätsmedizin Berlin, Clinical Study Center, German PROMIS® National Center, Berlin, Germany
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18
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Bade BC, Faiz SA, Ha DM, Tan M, Barton-Burke M, Cheville AL, Escalante CP, Gozal D, Granger CL, Presley CJ, Smith SM, Chamberlaine DM, Long JM, Malone DJ, Pirl WF, Robinson HL, Yasufuku K, Rivera MP. Cancer-related Fatigue in Lung Cancer: A Research Agenda: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med 2023; 207:e6-e28. [PMID: 36856560 PMCID: PMC10870898 DOI: 10.1164/rccm.202210-1963st] [Citation(s) in RCA: 12] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/02/2023] Open
Abstract
Background: Fatigue is the most common symptom among cancer survivors. Cancer-related fatigue (CRF) may occur at any point in the cancer care continuum. Multiple factors contribute to CRF development and severity, including cancer type, treatments, presence of other symptoms, comorbidities, and medication side effects. Clinically, increasing physical activity, enhancing sleep quality, and recognizing sleep disorders are integral to managing CRF. Unfortunately, CRF is infrequently recognized, evaluated, or treated in lung cancer survivors despite more frequent and severe symptoms than in other cancers. Therefore, increased awareness and understanding of CRF are needed to improve health-related quality of life in lung cancer survivors. Objectives: 1) To identify and prioritize knowledge and research gaps and 2) to develop and prioritize research questions to evaluate mechanistic, diagnostic, and therapeutic approaches to CRF among lung cancer survivors. Methods: We convened a multidisciplinary panel to review the available literature on CRF, focusing on the impacts of physical activity, rehabilitation, and sleep disturbances in lung cancer. We used a three-round modified Delphi process to prioritize research questions. Results: This statement identifies knowledge gaps in the 1) detection and diagnostic evaluation of CRF in lung cancer survivors; 2) timing, goals, and implementation of physical activity and rehabilitation; and 3) evaluation and treatment of sleep disturbances and disorders to reduce CRF. Finally, we present the panel's initial 32 research questions and seven final prioritized questions. Conclusions: This statement offers a prioritized research agenda to 1) advance clinical and research efforts and 2) increase awareness of CRF in lung cancer survivors.
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Petersen MA, Vachon H, Groenvold M. Development of a diverse set of standard short forms based on the EORTC CAT Core item banks. Qual Life Res 2023:10.1007/s11136-023-03373-6. [PMID: 36853573 DOI: 10.1007/s11136-023-03373-6] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/08/2023] [Indexed: 03/01/2023]
Abstract
PURPOSE The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed item banks covering the 14 domains of the EORTC QLQ-C30 quality of life questionnaire. These allow for dynamic assessment and for forming population/study specific static short forms. To simplify selection of relevant short forms, we here present a portfolio of standard short forms with measurement properties optimized for different populations. METHODS For each domain, a brief and a long version were constructed for each of three populations having mild, moderate, and severe symptoms, respectively. The most informative items were prioritised while also taking content into consideration. All short forms included at least one QLQ-C30 item. The measurement precision/power of the short forms was compared to the corresponding QLQ-C30 scales using simulations. RESULTS In total, 84 short forms were constructed. The brief versions included 3-5 items each, the long versions 5-9 items. Estimated sample size savings using the suggested short forms while maintaining the same power as with the QLQ-C30 ranged 3-50% across domains with median savings of 19% (brief versions) and 28% (long versions), respectively. CONCLUSION The suggested short forms allow for simple selection of items particularly relevant for patients with mild, moderate, or severe symptoms, respectively. They facilitate the use of smaller samples without loss of power compared to the QLQ-C30 scales. The suggested short forms may be used as they are or adapted to the specific aims of individual studies/settings.
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Affiliation(s)
- Morten Aa Petersen
- Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg & Frederiksberg Hospital, University of Copenhagen, Bispebjerg Bakke 23B, 2400, Copenhagen, NV, Denmark.
| | - Hugo Vachon
- Quality of Life Department, European Organization for Research and Treatment of Cancer, Brussels, Belgium
| | - Mogens Groenvold
- Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg & Frederiksberg Hospital, University of Copenhagen, Bispebjerg Bakke 23B, 2400, Copenhagen, NV, Denmark.,Department of Public Health, University of Copenhagen, Copenhagen, Denmark
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Aghdaee M, Gu Y, Sinha K, Parkinson B, Sharma R, Cutler H. Mapping the Patient-Reported Outcomes Measurement Information System (PROMIS-29) to EQ-5D-5L. PHARMACOECONOMICS 2023; 41:187-198. [PMID: 36336773 PMCID: PMC9883346 DOI: 10.1007/s40273-022-01157-3] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Accepted: 05/10/2022] [Indexed: 06/16/2023]
Abstract
BACKGROUND AND OBJECTIVE The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is gaining popularity as healthcare system funders increasingly seek value-based care. However, it is limited in its ability to estimate utilities and thus inform economic evaluations. This study develops the first mapping algorithm for estimating EuroQol 5-Dimension 5-Level (EQ-5D-5L) utilities from PROMIS-29 responses using a large dataset and through extensive comparisons between econometric models. METHODS An online survey was conducted to collect responses to PROMIS-29 and EQ-5D-5L from the general Australian population (N = 3013). Direct and indirect mapping methods were explored, including linear regression, Tobit, generalised linear model, censored regression model, beta regression (Betamix), the adjusted limited dependent variable mixture model (ALDVMM) and generalised ordered logit. The most robust model was selected by assessing the performance based on average ten-fold cross-validation geometric mean absolute error and geometric mean squared error, the predicted mean, maximum and minimum utilities, as well as the fitting across the entire distribution. RESULTS The direct approach using ALDVMM was considered the preferred model based on lowest geometric mean absolute error and geometric mean squared error in cross-validation (0.0882, 0.0299) and its superiority in predicting the actual observed mean, full health states and lower utility extremes. The robustness and precision in prediction across the entire distribution of utilities with ALDVMM suggest it is an accurate and valid mapping algorithm. Moreover, the suggested mapping algorithm outperformed previously published algorithms using Australian data, indicating the validity of this model for economic evaluations. CONCLUSIONS This study developed a robust algorithm to estimate EQ-5D-5L utilities from PROMIS-29. Consistent with the recent literature, the ALDVMM outperformed all other econometric models considered in this study, suggesting that the mixture models have relatively better performance and are an ideal candidate model for mapping.
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Affiliation(s)
- Mona Aghdaee
- Macquarie University Centre for the Health Economy, Macquarie University, Level 5, 75 Talavera Road, Sydney, NSW, 2109, Australia.
- Australian Institute of Health Innovation (AIHI), Macquarie University, Sydney, NSW, Australia.
| | - Yuanyuan Gu
- Macquarie University Centre for the Health Economy, Macquarie University, Level 5, 75 Talavera Road, Sydney, NSW, 2109, Australia
- Australian Institute of Health Innovation (AIHI), Macquarie University, Sydney, NSW, Australia
| | - Kompal Sinha
- Department of Economics, Macquarie Business School, Macquarie University, Sydney, NSW, Australia
| | - Bonny Parkinson
- Macquarie University Centre for the Health Economy, Macquarie University, Level 5, 75 Talavera Road, Sydney, NSW, 2109, Australia
- Australian Institute of Health Innovation (AIHI), Macquarie University, Sydney, NSW, Australia
| | - Rajan Sharma
- Macquarie University Centre for the Health Economy, Macquarie University, Level 5, 75 Talavera Road, Sydney, NSW, 2109, Australia
- Australian Institute of Health Innovation (AIHI), Macquarie University, Sydney, NSW, Australia
| | - Henry Cutler
- Macquarie University Centre for the Health Economy, Macquarie University, Level 5, 75 Talavera Road, Sydney, NSW, 2109, Australia
- Australian Institute of Health Innovation (AIHI), Macquarie University, Sydney, NSW, Australia
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21
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Bhaumik S, Beri D, Tyagi J, Clarke M, Sharma SK, Williamson PR, Jagnoor J. Outcomes in intervention research on snakebite envenomation: a systematic review. F1000Res 2022; 11:628. [PMID: 36300033 PMCID: PMC9579743 DOI: 10.12688/f1000research.122116.1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 05/20/2022] [Indexed: 01/13/2023] Open
Abstract
INTRODUCTION A core outcome set (COS) is a minimal list of consensus outcomes that should be used in all intervention research in a specific domain. COS enhance the ability to undertake meaningful comparisons and to understand the benefits or harms of different treatments. A first step in developing a COS is to identify outcomes that have been used previously. We did this global systematic review to provide the foundation for development of a region-specific COS for snakebite envenomation. Methods: We searched 15 electronic databases, eight trial registries, and reference lists of included studies to identify reports of relevant trials, protocols, registry records and systematic reviews. We extracted verbatim data on outcomes, their definitions, measures, and time-points. Outcomes were classified as per an existing outcome taxonomy, and we identified unique outcomes based on similarities in the definition and measurement of the verbatim outcomes. RESULTS We included 107 records for 97 studies which met our inclusion criteria. These reported 538 outcomes, with a wide variety of outcome measures, definitions, and time points for measurement. We consolidated these into 88 unique outcomes, which we classified into core areas of mortality (1, 1.14 %), life impact (6, 6.82%), resource use (15, 17.05%), adverse events (7, 7.95%), physiological/clinical (51, 57.95%), and composite (8, 9.09%) outcomes. The types of outcomes varied by the type of intervention, and by geographic region. Only 15 of the 97 trials (17.04%) listed Patient Related Outcome Measures (PROMS). CONCLUSION Trials evaluating interventions for snakebite demonstrate heterogeneity on outcomes and often omit important information related to outcome measurement (definitions, instruments, and time points). Developing high quality, region-specific COS for snakebite could inform the design of future trials and improve outcome reporting. Measurement of PROMS, resource use and life impact outcomes in trials on snakebite remains a gap.
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Affiliation(s)
- Soumyadeep Bhaumik
- Injury Division, The George Institute for Global Health, Faculty of Medicine, University of New South Wales,, Sydney, New South Wales, 2042, Australia
- Injury Division, The George Institute for Global Health, New Delhi, Delhi, 110025, India
- Meta-research and Evidence Synthesis Unit, George Institute for Global Health, New Delhi, Delhi, 110025, India
| | - Deepti Beri
- Injury Division, The George Institute for Global Health, New Delhi, Delhi, 110025, India
| | - Jyoti Tyagi
- Meta-research and Evidence Synthesis Unit, George Institute for Global Health, New Delhi, Delhi, 110025, India
| | - Mike Clarke
- Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK
| | - Sanjib Kumar Sharma
- Department of Internal Medicine, B.P. Koirala Institute of Health Sciences, Dharan, Nepal
| | - Paula R Williamson
- Department of Health Data Science, Institute of Population Health, University of Liverpool, Liverpool, UK
| | - Jagnoor Jagnoor
- Injury Division, The George Institute for Global Health, Faculty of Medicine, University of New South Wales,, Sydney, New South Wales, 2042, Australia
- Injury Division, The George Institute for Global Health, New Delhi, Delhi, 110025, India
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22
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Garcia L, Birckhead B, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Castro C, Maddox R, Maddox T, Darnall BD. Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: Follow-up Study of a Randomized Clinical Trial. J Med Internet Res 2022; 24:e37480. [PMID: 35612905 PMCID: PMC9177046 DOI: 10.2196/37480] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2022] [Revised: 03/22/2022] [Accepted: 04/26/2022] [Indexed: 12/19/2022] Open
Abstract
Background We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding). Objective This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR. Methods E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function. Results Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (ds=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness. Conclusions Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples. Trial Registration ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 International Registered Report Identifier (IRRID) RR2-10.2196/25291
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Affiliation(s)
| | | | | | | | | | - Vafi Salmasi
- Stanford University School of Medicine, Palo Alto, CA, United States
| | - Robert Louis
- Hoag Memorial Hospital, Newport Beach, CA, United States
| | | | | | | | - Beth D Darnall
- Stanford School of Medicine, Palo Alto, CA, United States
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23
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Lane E, Magel JS, Thackeray A, Greene T, Fino NF, Puentedura EJ, Louw A, Maddox D, Fritz JM. Effectiveness of training physical therapists in pain neuroscience education for patients with chronic spine pain: a cluster-randomized trial. Pain 2022; 163:852-860. [PMID: 34354017 PMCID: PMC8816964 DOI: 10.1097/j.pain.0000000000002436] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2021] [Accepted: 07/30/2021] [Indexed: 11/26/2022]
Abstract
ABSTRACT Chronic spinal pain poses complex challenges for health care around the world and is in need of effective interventions. Pain neuroscience education (PNE) is a promising intervention hypothesized to improve pain and disability by changing individuals' beliefs, perceptions, and expectations about pain. Pain neuroscience education has shown promise in small, controlled trials when implemented in tightly controlled situations. Exploration of promising interventions through more pragmatic methodologies is a crucial but understudied step towards improving outcomes in routine clinical care. The purpose was to examine the impact of pragmatic PNE training on clinical outcomes in patients with chronic spine pain. The cluster-randomized clinical trial took place in 45 outpatient physical therapist (PT) clinics. Participants included 108 physical therapists (45 clinics and 16 clusters) and 319 patients. Clusters of PT clinics were randomly assigned to either receive training in PNE or no intervention and continue with usual care (UC). We found no significant differences between groups for our primary outcome at 12 weeks, Patient-Reported Outcomes Measurement Information System Physical Function computer adaptive test {mean difference = 1.05 (95% confidence interval [CI]: -0.73 to 2.83), P = 0.25}. The PNE group demonstrated significant greater improvements in pain self-efficacy at 12 and 2 weeks compared with no intervention (mean difference = 3.65 [95% CI: 0.00-7.29], P = 0.049 and = 3.08 [95% CI: 0.07 to -6.09], P = 0.045, respectively). However, a similar percentage of participants in both control (41.1%) and treatment (44.4%) groups reported having received the treatment per fidelity question (yes or no to pain discussed as a perceived threat) at 2 weeks. Pragmatic PT PNE training and delivery failed to produce significant functional changes in patients with chronic spinal pain but did produce significant improvement in pain self-efficacy over UC PT.
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Affiliation(s)
- Elizabeth Lane
- Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, United States
| | - John S. Magel
- Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, United States
| | - Anne Thackeray
- Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, United States
| | - Tom Greene
- Department of Internal Medicine, School of Medicine, University of Utah, Salt Lake City, UT, United States
- Population Health, Research Study Design and Biostatistics Center, School of Medicine, University of Utah, Salt Lake City, UT, United States
| | - Nora F. Fino
- Division of Epidemiology, School of Medicine, University of Utah, Salt Lake City, UT, United States
| | | | - Adriaan Louw
- Department of Physical Therapy, Evidence in Motion, San Antonio, TX, United States
| | - Daniel Maddox
- Department of Physical Therapy, Brenau University, Gainesville, GA, United States
| | - Julie M. Fritz
- Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, United States
- College of Health, University of Utah, Salt Lake City, UT, United States
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Linking the KOOS-PS to PROMIS Physical Function in Knee Patients Evaluated for Surgery. J Am Acad Orthop Surg 2022; 30:281-289. [PMID: 35171872 DOI: 10.5435/jaaos-d-21-00461] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/15/2021] [Accepted: 12/23/2021] [Indexed: 02/01/2023] Open
Abstract
INTRODUCTION The Knee Injury and Osteoarthritis Outcome Score-Physical Function Short-form and the Patient-Reported Outcomes Measurement Information System Physical Function are widely used patient-reported outcome measures in orthopaedic practice and research. It would be helpful for clinicians and researchers to compare scores obtained on one instrument with those collected on another. To achieve this goal, this study conducted a linking analysis and computed a crosswalk table between these two scales. DATA The data of this study were collected as part of the clinical care of total knee arthroplasty patients in a large urban and suburban health system. The sample was a mix of responses from nonsurgical (no surgery performed), preoperative (before surgical intervention), and postoperative (after surgical intervention) groups. METHODS This study applied five linking methods: the item response theory (IRT)-based linking methods including fixed-parameter calibration, separate-parameter calibration with Stocking-Lord constants, and calibrated projection; and the equipercentile methods with log-linear smoothing and nonsmoothing approaches. Before conducting the linking analysis, we checked the linking assumptions including the similar content of the two scales, the unidimensionality of the combined scales, and the population invariance. The results of the five linking methods were evaluated by mean difference, SD, root-mean-squared deviation, intraclass correlation coefficient of the observed T scores and the crosswalk-derived T scores. RESULTS The linking assumptions were all met. T scores generated from the Stocking-Lord crosswalk had the smallest mean difference (= -0.03) and relatively small SD (= 4.91) and root-mean-squared deviation (= 4.91) among the five linking methods. We validated this crosswalk in a larger sample with the nonsurgical, preoperative, and postoperative groups and in an external sample. DISCUSSION This study provides clinicians and researchers a practical tool (ie, a crosswalk table) to link scores from two popular physical function measures. Given the diversity of patient-reported outcome measures in use for knee conditions, these crosswalk tables would accelerate clinical and research interpretation of aggregating functional outcomes among the patients evaluated for knee surgery each year.
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25
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Holeman TA, Groberg J, Beckstrom JL, Brooke BS. Patient Reported Physical Function as a Preoperative Predictor of Recovery After Vascular Surgery. J Vasc Surg 2022; 76:564-571.e1. [DOI: 10.1016/j.jvs.2022.02.051] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2021] [Accepted: 02/06/2022] [Indexed: 11/27/2022]
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26
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Chew E, Perin J, Grader-Beck T, Orbai AM. Measurement of Minimal Disease Activity in Psoriatic Arthritis Using the Patient-Reported Outcomes Measurement Information System-Physical Function or the Health Assessment Questionnaire Disability Index. Arthritis Care Res (Hoboken) 2022; 74:151-160. [PMID: 32860727 PMCID: PMC7914287 DOI: 10.1002/acr.24433] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2020] [Accepted: 08/18/2020] [Indexed: 01/03/2023]
Abstract
OBJECTIVE To assess the interchangeability of the Health Assessment Questionnaire disability index (HAQ DI) with the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) in the calculation of minimal disease activity (MDA) in psoriatic arthritis (PsA). METHODS Comprehensive PsA disease activity was collected concomitantly with the HAQ DI and the PROMIS-PF measures in a PsA cohort. The PROMIS-PF-based MDA definitions were built using the existing cross-walk between the scores: HAQ DI ≤0.5 equivalent to a PROMIS-PF T score of ≥41.3. We assessed agreement between MDA (MDA HAQ DI) and the PROMIS-PF MDA definitions (MDA PROMIS-PF short form 4a and MDA PROMIS-PF bank) at each visit and longitudinally (MDA state changes between consecutive visits) through the kappa statistic. The predictive value of the MDA PROMIS-PF for the MDA HAQ DI was assessed using receiver operator characteristic (ROC) curve analysis. RESULTS A total of 100 participants contributed 352 observations with up to 5 visits. The mean ± SD age was 52 ± 12 years, 60% were female, and 43% were in MDA at baseline. The kappa statistic for the PROMIS-PF-based MDA reflected excellent agreement with the HAQ DI MDA: κ = 0.94 (95% confidence interval [95% CI] 0.90-0.97) for MDA PROMIS-PF bank, and κ = 0.90 (95% CI 0.80-0.95) for MDA PROMIS-PF4a. Higher longitudinal agreement was seen between the MDA HAQ DI and the MDA PROMIS-PF bank versus the MDA PROMIS-PF4a between consecutive visits: κ values ranged between 0.81 and 0.94 versus a range between 0.72 and 0.84, respectively. The area under the ROC curve for predicting the MDA HAQ DI was 0.97 for the MDA PROMIS-PF bank and 0.95 for the MDA PROMIS-PF4a. CONCLUSION Excellent agreement was seen between the HAQ DI and the PROMIS-based MDA definitions both cross-sectionally and longitudinally. The PROMIS-PF bank and PROMIS-PF4a are accurate replacements for the HAQ DI in calculating MDA state in PsA.
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Affiliation(s)
- Erin Chew
- Johns Hopkins University School of Medicine Division of Rheumatology, Baltimore, MD,Johns Hopkins Hospital. Baltimore, MD
| | - Jamie Perin
- Johns Hopkins University School of Public Health, Department of International Health, Baltimore
| | - Thomas Grader-Beck
- Johns Hopkins University School of Medicine Division of Rheumatology, Baltimore, MD
| | - Ana-Maria Orbai
- Johns Hopkins University School of Medicine Division of Rheumatology, Baltimore, MD
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27
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Garcia LM, Birckhead BJ, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Maddox T, Darnall BD. Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain. THE JOURNAL OF PAIN 2021; 23:822-840. [PMID: 34902548 DOI: 10.1016/j.jpain.2021.12.002] [Citation(s) in RCA: 24] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/05/2021] [Revised: 11/21/2021] [Accepted: 12/07/2021] [Indexed: 10/19/2022]
Abstract
Prior work established post-treatment efficacy for an 8-week home-based therapeutic virtual reality (VR) program in a double-blind, parallel arm, randomized placebo-controlled study. Participants were randomized 1:1 to 1 of 2 56-day VR programs: 1) a therapeutic immersive pain relief skills VR program; or 2) a Sham VR program within an identical commercial VR headset. Immediate post-treatment results demonstrated clinically meaningful and superior reduction for therapeutic VR compared to Sham VR for average pain intensity, indices of pain-related interference (activity, mood, stress but not sleep), physical function, and sleep disturbance. The objective of the current report was to quantify treatment effects to post-treatment month 3 and describe durability of effects. Intention-to-treat analyses revealed sustained benefits for both groups and superiority for therapeutic VR for pain intensity and multiple indices of pain-related interference (activity, stress, and newly for sleep; effect sizes ranged from drm = .56-.88) and physical function from pre-treatment to post-treatment month 3. The between-group difference for sleep disturbance was non-significant and pain-interference with mood did not survive multiplicity correction at 3 months. For most primary and secondary outcomes, treatment effects for therapeutic VR showed durability, and maintained superiority to Sham VR in the 3-month post-treatment period. PERSPECTIVE: We present 3-month follow-up results for 8-week self-administered therapeutic virtual reality (VR) compared to Sham VR in adults with chronic low back pain. Across multiple pain indices, therapeutic VR had clinically meaningful benefits, and superiority over Sham VR. Home-based, behavioral skills VR yielded enduring analgesic benefits; longer follow-up is needed.
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Affiliation(s)
- Laura M Garcia
- AppliedVR, Inc, University of Southern California, Creative Media and Behavioral Health Center, Los Angeles, California
| | - Brandon J Birckhead
- Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland
| | | | | | | | - Vafi Salmasi
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California
| | - Robert Louis
- Division of Neurosurgery, Pickup Family Neurosciences Institute, Hoag Memorial Hospital Newport Beach, CA, United States, Newport Beach, California
| | | | - Beth D Darnall
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.
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28
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Obey MR, Goldfarb CA, Broughton JS, Gebhart SS, Smith MV. Early Improvement in Patient-Reported Outcome Scores After Operative Treatment of Osteochondritis Dissecans of the Humeral Capitellum. J Hand Surg Am 2021; 46:1120.e1-1120.e7. [PMID: 33931273 DOI: 10.1016/j.jhsa.2021.03.003] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/09/2020] [Revised: 12/14/2020] [Accepted: 03/02/2021] [Indexed: 02/02/2023]
Abstract
PURPOSE Outcome measures that lack sensitivity for the detection of clinical changes early after surgery for capitellar osteochondritis dissecans (OCD) make it difficult to determine the optimal treatment for these defects. We sought to evaluate the early responsiveness of patient-reported outcomes measurement information system (PROMIS) scores in a cohort of patients operatively treated for capitellar OCD. METHODS Four PROMIS questionnaires (mobility, upper extremity [UE], pain interference, and peer relations) were electronically administered to patients treated for capitellar OCD at a single tertiary academic medical center between January 1, 2015, and July 1, 2018. The questionnaires were administered at the initial preoperative outpatient clinic visit as well as at the 2-week, 6-week, and final return-to-play (RTP) visits. RESULTS Twenty-nine patients (31 elbows, mean age 12.9 years) with available preoperative and postoperative PROMIS data were included. The mean final follow-up period was 26 weeks. Compared with that before surgery, there was a significant improvement in the mobility, pain interference, and UE scores at 6 weeks following surgery. The scores improved most significantly by 6 weeks, reached a relative plateau, and remained significantly improved through the RTP visit thereafter. Patients with preoperative, intra-articular loose bodies scored significantly better than those without them during the 6-week and RTP visits. Patients with lesions >1 cm2, compared with those with lesions ≤1 cm2, demonstrated greater improvement in the UE scores during the RTP visit. CONCLUSIONS In patients undergoing operative treatment for capitellar OCD, a significant improvement in the PROMIS domains of mobility, pain interference, and UE can be expected early in the postoperative period, with majority of patients reaching their greatest improvement in scores by 6 weeks following surgery. CLINICAL RELEVANCE This is important information for preoperative counseling. In addition, this information is helpful in confirming that PROMIS scores are responsive in the detection of changes in outcomes during the early postoperative period in this population.
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Affiliation(s)
- Mitchel R Obey
- Department of Orthopedic Surgery, Washington University, St. Louis, MO
| | | | - J Sam Broughton
- Department of Orthopedic Surgery, Washington University, St. Louis, MO
| | - Sandra S Gebhart
- Department of Orthopedic Surgery, Washington University, St. Louis, MO
| | - Matthew V Smith
- Department of Orthopedic Surgery, Washington University, St. Louis, MO.
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29
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van Wissen MAT, Teuwen MMH, van den Ende CHM, Vliet Vlieland TPM, den Broeder AA, van den Hout WB, Peter WF, van Schaardenburg D, van Tubergen AM, Gademan MGJ, van Weely SFE. Effectiveness and cost-effectiveness of longstanding exercise therapy versus usual care in patients with axial spondyloarthritis or rheumatoid arthritis and severe limitations: The protocols of two parallel randomized controlled trials. PHYSIOTHERAPY RESEARCH INTERNATIONAL 2021; 27:e1933. [PMID: 34780107 PMCID: PMC9285698 DOI: 10.1002/pri.1933] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2021] [Accepted: 10/09/2021] [Indexed: 12/05/2022]
Abstract
Objectives Research on effectiveness and cost‐effectiveness of longstanding exercise therapy in patients with axial SpondyloArthritis (axSpA) or Rheumatoid Arthritis (RA) is scarce, and mainly concerned patients with a relatively favorable health status. We aim to evaluate the effectiveness and cost‐effectiveness of longstanding exercise therapy compared to usual care in the subgroup of patients with axSpA or RA and severe limitations in functioning. Methods In two separate, parallel randomized controlled trials the effectiveness and cost‐effectiveness of longstanding, active exercise therapy (52 weeks) compared with usual care (1:1) will be evaluated. The longstanding, active exercise therapy will focus on improving individual limitations in daily activities and participation and will be given by a trained physical therapist in the vicinity of the participant. For each diagnosis, 215 patients with severe limitations in activities and participation will be included. Assessments are performed at baseline, 12, 26, and 52 weeks. The primary outcome measure of effectiveness is the individual level of functioning (activities and participation), as measured with the Patient‐Specific Complaints instrument at 52 weeks. For cost‐effectiveness analyses, the EuroQol (EQ‐5D‐5L) and questionnaires on healthcare use and productivity will be administered. The economic evaluation will be a cost‐utility analysis from a societal perspective. After 52 weeks, the patients in the usual care group are offered longstanding, active exercise therapy as well. Follow‐up assessments are done at 104, 156, and 208 weeks. Conclusion The results of these studies will provide insights in the effectiveness and cost‐effectiveness of longstanding exercise therapy in the subgroup of axSpA and RA patients with severe functional limitations.
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Affiliation(s)
- Maria A T van Wissen
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands
| | - Max M H Teuwen
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands
| | - Cornelia H M van den Ende
- Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.,Department of Rheumatology, Radboud UMC, Nijmegen, The Netherlands
| | - Thea P M Vliet Vlieland
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands
| | - Alfons A den Broeder
- Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.,Department of Rheumatology, Radboud UMC, Nijmegen, The Netherlands
| | - Wilbert B van den Hout
- Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands
| | - Wilfred F Peter
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands
| | | | - Astrid M van Tubergen
- Department of Rheumatology, Maastricht University Medical Center, Maastricht, The Netherlands.,The Netherlands and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
| | - Maaike G J Gademan
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.,Department of Clinical epidemiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Salima F E van Weely
- Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands
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Abu-Amer W, Lawrie CM, Thapa S, Nepple JJ, Clohisy JC. Does the Patient-Reported Outcomes Measurement Information System Correlate to Legacy Scores in Measuring Physical Health in Young Total Hip Arthroplasty Patients? J Arthroplasty 2021; 36:3478-3484. [PMID: 34332792 DOI: 10.1016/j.arth.2021.06.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/28/2021] [Revised: 06/04/2021] [Accepted: 06/05/2021] [Indexed: 02/02/2023] Open
Abstract
BACKGROUND The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed by the National Institutes of Health to collect outcome data in rapid dynamic fashion on electronic platforms. The potential role of PROMIS in monitoring pain and function in young total hip arthroplasty (THA) patients has been under-investigated. The purpose of this study is to investigate correlation between PROMIS Physical Function (PF) and PROMIS Pain Interference (PI) and legacy scores with similar considerations. METHODS We identified 298 hips who underwent primary THA over 40 months. Patients without preoperative PROMIS or legacy scores, or >50 years were excluded. Demographic data included age, gender, and body mass index. Outcome data included PF, PI, modified Harris Hip Score (mHHS), Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) domains, and Short Form 12 components. Floor/ceiling effects were considered to be significant if ≥15% of patients responded with the lowest or highest possible score. Spearman correlation (R) was performed to investigate correlation between legacy scores and PROMIS domains. RESULTS Mean age was 40 years, mean body mass index was 30.1 kg/m2, and 55% were female. None of the patient-reported outcome measures showed any floor/ceiling effects. PI showed moderate correlation to mHHS (R = -0.60), WOMAC Pain (R = -0.62), and WOMAC PF (R = -0.60). PF showed moderate correlation to mHHS (R = 0.66) and WOMAC PF (R = 0.55). Mean PF and PI scores differed significantly from the general population mean of 50 (36.7, 65.4, respectively; both P < .001). CONCLUSION PROMIS is an attractive alternative to legacy scoring measures, showing moderate correlations between PROMIS physical domains and legacy PROMs of WOMAC and mHHS in young patients undergoing THA.
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Affiliation(s)
- Wahid Abu-Amer
- Department of Orthopaedic Surgery, Washington University School of Medicine, St Louis, MO
| | - Charles M Lawrie
- Department of Orthopaedic Surgery, Washington University School of Medicine, St Louis, MO
| | - Susan Thapa
- Department of Orthopaedic Surgery, Washington University School of Medicine, St Louis, MO
| | - Jeffrey J Nepple
- Department of Orthopaedic Surgery, Washington University School of Medicine, St Louis, MO
| | - John C Clohisy
- Department of Orthopaedic Surgery, Washington University School of Medicine, St Louis, MO
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Blomqvist I, Chaplin JE, Nilsson E, Henje E, Dennhag I. Swedish translation and cross-cultural adaptation of eight pediatric item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS) ®. J Patient Rep Outcomes 2021; 5:80. [PMID: 34487250 PMCID: PMC8421493 DOI: 10.1186/s41687-021-00353-7] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/01/2021] [Accepted: 08/24/2021] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND This study is part of the Swedish initiative for the establishment of standardized, modern patient-reported measures for national use in Swedish healthcare. The goal was to translate and culturally adapt eight pediatric Patient-Reported Outcomes Measurement Information System (PROMIS®) item banks (anger, anxiety, depressive symptoms, family relationships, fatigue, pain interference, peer relationships and physical activity) into Swedish. METHODS Authorization to translate all currently available pediatric PROMIS item banks (autumn, 2016) into Swedish was obtained from the PROMIS Health Organization. The translation followed the Functional Assessment of Chronic Illness Therapy translation recommendations with one major modification, which was the use of a bilingual multi-professional review workshop. The following steps were applied: translation, reconciliation, a two-day multi professional reviewer workshop, back translation, and cognitive debriefing with eleven children (8-17 years) before final review. The bilingual multi-professional review workshop provided a simultaneous, in-depth assessment from different professionals. The group consisted of questionnaire design experts, researchers experienced in using patient-reported measures in healthcare, linguists, and pediatric healthcare professionals. RESULTS All item banks had translation issues that needed to be resolved. Twenty-four items (20.7%) needed resolution at the final review stage after cognitive debriefing. The issues with translations included 1. Lack of matching definitions with items across languages (6 items); 2. Problems related to language, vocabulary, and cultural differences (6 items); and 3. Difficulties in adaptation to age-appropriate language (12 items). CONCLUSIONS The translated and adapted versions of the eight Swedish pediatric PROMIS item banks are linguistically acceptable. The next stage will be cross-cultural validation studies in Sweden. Despite the fact that there are cultural differences between Sweden and the United States, our translation processes have successfully managed to address all issues. Expert review groups from already-established networks and processes regarding pediatric healthcare throughout the country will facilitate the future implementation of pediatric PROMIS item banks in Sweden.
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Affiliation(s)
- Ida Blomqvist
- Department of Clinical Science, Child- and Adolescent Psychiatry, Umeå University, 90185, Umeå, Sweden.
| | - John Eric Chaplin
- Department of Pediatrics, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden
| | - Evalill Nilsson
- Department of Medicine and Optometry, Linnaeus University, Kalmar, Sweden
| | - Eva Henje
- Department of Clinical Science, Child- and Adolescent Psychiatry, Umeå University, 90185, Umeå, Sweden
| | - Inga Dennhag
- Department of Clinical Science, Child- and Adolescent Psychiatry, Umeå University, 90185, Umeå, Sweden
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Mosor E, Studenic P, Alunno A, Padjen I, Olsder W, Ramiro S, Bini I, Caeyers N, Gossec L, Kouloumas M, Nikiphorou E, Stones S, Wilhelmer TC, Stamm TA. Young people's perspectives on patient-reported outcome measures in inflammatory arthritis: results of a multicentre European qualitative study from a EULAR task force. RMD Open 2021; 7:rmdopen-2020-001517. [PMID: 33514672 PMCID: PMC7849893 DOI: 10.1136/rmdopen-2020-001517] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2020] [Revised: 12/24/2020] [Accepted: 01/14/2021] [Indexed: 01/04/2023] Open
Abstract
INTRODUCTION Although patient-reported outcome measures (PROMs) are increasingly used in clinical practice and research, it is unclear whether these instruments cover the perspective of young people with inflammatory arthritis (IA). The aims of this study were to explore whether PROMs commonly used in IA adequately cover the perspective of young people from different European countries. METHODS A multinational qualitative study was conducted in Austria, Croatia, Italy and the Netherlands. Young people with either rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Still's disease, psoriatic arthritis (PsA) or spondyloarthritis (SpA), aged 18-35 years, participated in semistructured focus group interviews. Thematic analysis was used and data saturation was defined as no new emergent concepts in at least three subsequent focus groups. RESULTS Fifty-three patients (21 with RA/JIA/Still's, 17 with PsA, 15 with SpA; 72% women) participated in 12 focus groups. Participants expressed a general positive attitude towards PROMs and emphasised their importance in clinical practice. In addition, 48 lower level concepts were extracted and summarised into 6 higher level concepts describing potential issues for improvement. These included: need for lay-term information regarding the purpose of using PROMs; updates of certain outdated items and using digital technology for data acquisition. Some participants admitted their tendency to rate pain, fatigue or disease activity differently from what they actually felt for various reasons. CONCLUSIONS Despite their general positive attitude, young people with IA suggested areas for PROM development to ensure that important concepts are included, making PROMs relevant over the entire course of a chronic disease.
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Affiliation(s)
- Erika Mosor
- Section for Outcomes Research, Centre for Medical Statistics, Informatics and Intelligent Systems, Medical University Vienna, Wien, Austria
| | - Paul Studenic
- Internal Medicine 3, Division of Rheumatology, Medical University Vienna, Wien, Austria.,Department of Medicine (Solna), Division of Rheumatology, Karolinska Institute, Stockholm, Sweden
| | - Alessia Alunno
- Department of Medicine, Rheumatology Unit, University of Perugia, Perugia, Umbria, Italy
| | - Ivan Padjen
- Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, University Hospital Centre Zagreb, Zagreb, Croatia.,University of Zagreb, School of Medicine, Zagreb, Croatia
| | - Wendy Olsder
- EULAR Young PARE, Zürich, Switzerland.,Youth-R-Well, Nieuwegein, The Netherlands
| | - Sofia Ramiro
- Rheumatology, Leiden University Medical Center, Leiden, South Holland, The Netherlands.,Rheumatology, Zuyderland Medical Centre Heerlen, Heerlen, Limburg, The Netherlands
| | - Ilaria Bini
- EULAR Young PARE, Zürich, Switzerland.,Anmar Young, Rome, Italy
| | - Nele Caeyers
- EULAR PARE, Zurich, Switzerland.,ReumaNET, Leuven, Belgium
| | - Laure Gossec
- Pierre Louis Institute of Epidemiology and Public Health, Sorbonne University, Paris, France.,APHP, Rheumatology Department, Pitie Salpetriere University Hospital, Paris, France
| | | | - Elena Nikiphorou
- Centre for Rheumatic Diseases, King's College London, London, UK.,Rheumatology Department, King's College Hospital NHS Trust, London, UK
| | - Simon Stones
- EULAR Patient Research Partner, Manchester, UK.,University of Leeds, Leeds, West Yorkshire, UK
| | | | - Tanja A Stamm
- Section for Outcomes Research, Centre for Medical Statistics, Informatics and Intelligent Systems, Medical University Vienna, Wien, Austria
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Establishing Age-calibrated Normative PROMIS Scores for Hand and Upper Extremity Clinic. PLASTIC AND RECONSTRUCTIVE SURGERY-GLOBAL OPEN 2021; 9:e3768. [PMID: 34422532 PMCID: PMC8373557 DOI: 10.1097/gox.0000000000003768] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/17/2021] [Accepted: 06/22/2021] [Indexed: 01/12/2023]
Abstract
The purpose of our study is to investigate differences in normative PROMIS upper extremity function (PROMIS-UE), physical function (PROMIS-PF), and pain interference (PROMIS-PI) scores across age cohorts in individuals without upper extremity disability.
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Kancharla H, Jain S, Mishra S, Acharya N, Grover S, Dogra S, Sharma A. Fibromyalgia influences health-related quality of life and disease activity in psoriatic arthritis. Rheumatol Int 2021; 42:511-517. [PMID: 34251497 DOI: 10.1007/s00296-021-04925-0] [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: 05/11/2021] [Accepted: 06/14/2021] [Indexed: 10/20/2022]
Abstract
Fibromyalgia syndrome (FMS) is common in patients of psoriatic arthritis (PsA), but the magnitude of its impact is uncertain. This cross-sectional study evaluated the impact of FMS on health-related quality of life (HRQoL) and disease activity in PsA. Adults classified with PsA (CASPAR criteria) at the rheumatology and dermatology outpatient clinics of PGIMER, Chandigarh, India between January 2014 and June 2015 were recruited. All patients were assessed for FMS using the 2010 ACR criteria. Health-related quality of life was assessed using PROMIS-HAQ, HAQ-pain, HAQ-health and revised fibromyalgia impact questionnaire (FIQR). Disease activity measures (SJC, TJC, BASDAI, enthesitis, dactylitis, PASI) and PROMIS-HAQ were correlated with measures of FMS [FIQR, symptom severity scale (SSS) score and widespread pain index (WPI)]. Multivariate regression analyses were used to identify predictors of PROMIS-HAQ and FMS. Out of 106 PsA patients screened, 102 [50 (49%) females; mean age 43.8 (12.4) years] were included. 19 (18.3%) had FMS. Patients of PsA with FMS had significantly (p < 0.05) higher TJC (14 vs 7), SJC (10 vs 5), BASDAI (6.1 vs 4.1) and enthesitis (53 vs 33%), but no difference in dactylitis, severity of skin disease and disease duration. A significant positive correlation of measures of FMS (FIQR, SSS and WPI) with SJC, TJC and BASDAI was noted. PROMIS-HAQ, HAQ-pain and HAQ-health were significantly worse (p < 0.001) in patients of PsA with coexisting FMS. Presence of FMS was found to be an independent predictor of worse PROMIS-HAQ. Female gender and higher TJC independently predicted presence of FMS. To conclude, FMS is an important contributor towards poor HRQoL in patients of PsA and is associated with higher values of joint disease activity measures.
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Affiliation(s)
- Harish Kancharla
- Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Siddharth Jain
- Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Sushant Mishra
- Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Nupoor Acharya
- Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Sandeep Grover
- Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Sunil Dogra
- Department of Dermatology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Aman Sharma
- Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
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Broughton JS, Goldfarb CA, Obey MR, Smith MV. Performance of Patient-Reported Outcomes Measurement Information System (PROMIS) scores compared with legacy metrics in evaluating outcomes after surgical treatment for osteochondritis dissecans of the humeral capitellum. J Shoulder Elbow Surg 2021; 30:1511-1518. [PMID: 33486062 DOI: 10.1016/j.jse.2020.11.032] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/06/2020] [Revised: 11/23/2020] [Accepted: 11/25/2020] [Indexed: 02/01/2023]
Abstract
BACKGROUND Patient-Reported Outcomes Measurement Information System (PROMIS) scores have not previously been used to measure long-term outcomes in operatively treated capitellar osteochondritis dissecans (OCD) patients. The aims of our study were to (1) assess patients' long-term outcomes using PROMIS scores, (2) compare the performance of PROMIS with other validated elbow legacy metrics, and (3) evaluate ceiling and floor effects in these outcome measures in patients undergoing surgical treatment for capitellar OCD. METHODS We evaluated demographic characteristics, procedure details, preoperative PROMIS scores, and associated sports information in surgically treated pediatric capitellar OCD patients. An online survey was sent to the study participants, including the Kerlan-Jobe Orthopaedic Clinic (KJOC) shoulder and elbow score, the quick Disabilities of the Arm, Shoulder and Hand questionnaire, and the Liverpool Elbow Score patient-answered questionnaire, as well as the Mobility, Pain Interference, and Upper Extremity questionnaires from the PROMIS pediatrics bank. Correlations were evaluated between outcome measures. Ceiling and floor effects were evaluated for each outcome measure. RESULTS Completed surveys were obtained for 57 patients (59 elbows). The mean patient age at surgery was 14 years (range, 10-18 years). The mean follow-up time was 6 years (standard deviation, 5 years; range, 1-18 years). The mean PROMIS Mobility score improved from 41.2 preoperatively to 55.2 postoperatively (P < .001). The mean Pain Interference score decreased from 46.9 preoperatively to 38 postoperatively (P < .001). The mean Upper Extremity score improved from 42.7 preoperatively to 53.2 postoperatively (P < .001). Significant correlations were observed between all legacy metrics and postoperative PROMIS scores (|r| > 0.54, P < .001). Ceiling or floor effects were seen in all legacy metrics and PROMIS scores. The KJOC score was least affected by ceiling or floor effects. CONCLUSION There is a strong correlation between PROMIS scores and legacy measures evaluating outcomes after surgical management of capitellar OCD. However, large ceiling and floor effects were present in all measures, likely owing to the favorable clinical results. The KJOC score was limited the least by ceiling and floor effects.
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Affiliation(s)
- James Sam Broughton
- Department of Orthopedics, Washington University in St. Louis, St. Louis, MO, USA
| | - Charles A Goldfarb
- Department of Orthopedics, Washington University in St. Louis, St. Louis, MO, USA
| | - Mitchel R Obey
- Department of Orthopedics, Washington University in St. Louis, St. Louis, MO, USA
| | - Matthew V Smith
- Department of Orthopedics, Washington University in St. Louis, St. Louis, MO, USA.
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Physical Performance Tests Correlate With Patient-reported Outcomes After Periacetabular Osteotomy: A Prospective Study. JOURNAL OF THE AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS GLOBAL RESEARCH AND REVIEWS 2021; 5:01979360-202106000-00008. [PMID: 34106906 PMCID: PMC8189615 DOI: 10.5435/jaaosglobal-d-21-00100] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 04/23/2021] [Accepted: 05/03/2021] [Indexed: 12/05/2022]
Abstract
Introduction: Individuals with hip dysplasia report significant functional disability that improves with periacetabular osteotomy (PAO). Four physical performance measures (PPMs) have been recently validated for use with nonarthritic hip conditions; however, their ability to detect functional improvement and correlate with improvements in popular hip-specific patient-reported outcome (PRO) instruments after PAO is unknown. The purpose of this study was to evaluate the responsiveness of four PPMs up to 1 year after PAO, compare PPMs with established PRO measures at these time points, and report the acceptability and utility of PPMs for assessing outcomes after PAO. Methods: Twenty-two participants aged 15 to 39 years completed the timed stair ascent (TSA), sit-to-stand five times (STS5), self-selected walking speed, four-square-step test, and seven hip-specific PRO measures before surgery and at approximately 6 months and 1 year after PAO. They completed questions regarding acceptability and utility of both types of testing. Wilcoxon rank sum test and unpaired Student t-tests were used to assess differences between time points; Spearman correlation and generalized linear modeling were used to determine the relationship between PPMs and PRO measures. Results: Six months after PAO, participants showed significant improvements on all seven PRO instruments (P < 0.001) and on the STS5 (P = 0.01). At one year, these improvements were maintained and TSA also improved (P = 0.03). Improvement in other PPMs did not reach significance (P = 0.07 and 0.08). The STS5 test demonstrated moderate to strong correlation (|r| = 0.43 to 0.76, P < 0.05) with all PRO measures, and the TSA test demonstrated moderate to strong correlation with almost all measures (|r| = 0.43 to 0.58, P < 0.05). Correlations strengthened on subanalysis of participants with unilateral disease (n = 11) (|r| = 0.56 to 0.94, P < 0.05). All participants (100%) found PPM testing acceptable despite disability; 25% preferred PPMs to PRO measures, whereas 75% of participants found them equal in usefulness. Discussion: The STS5 and TSA tests demonstrated moderate to very strong correlation with PRO measures at six and 12 months after PAO for dysplasia. These tests could be used as a functional outcome to supplement PRO instruments after PAO.
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Long C, Beres LK, Wu AW, Giladi AM. Developing a protocol for adapting multimedia patient-reported outcomes measures for low literacy patients. PLoS One 2021; 16:e0252684. [PMID: 34086774 PMCID: PMC8177453 DOI: 10.1371/journal.pone.0252684] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/26/2021] [Accepted: 05/19/2021] [Indexed: 11/19/2022] Open
Abstract
BACKGROUND Self-administration of patient-reported outcomes measures (PROMs) by patients with low literacy is a methodologic and implementation challenge. There is an increasing emphasis on patient-centered care and wider adoption of PROMs to understand outcomes and measure healthcare quality. However, there is a risk that the use of PROMs could perpetuate health disparities unless they are implemented in an inclusive fashion. We present a protocol to adapt validated, text-based PROMs to a multimedia format (mPROMs) to optimize self-administration in populations with limited literacy. We describe the processes used to develop the protocol and the planned protocol implementation. METHODS/DESIGN Our study protocol development was guided by the International Quality of Life Assessment (IQOLA) protocol for translating and culturally adapting PROMs to different languages. We used the main components of IQOLA's protocol to generate a conceptual framework to guide development of a Multimedia Adaptation Protocol (MAP). The MAP, which incorporates human-centered design (HCD) and takes a community-engaged research approach, includes four stages: forward adaptation, backward adaptation, qualitative evaluation, and validation. The MAP employs qualitative and quantitative methods including observation, cognitive and discovery interviews, ideation workshops, prototyping, user testing, co-creation interviews, and psychometric testing. An iterative design is central to the MAP and consistent with both the IQOLA protocol and HCD processes. We will pilot test and execute the MAP to adapt the Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Short Form for use in a mixed literacy hand and upper extremity patient population in Baltimore, Maryland. DISCUSSION The MAP provides an approach for adapting PROMs to a multimedia format. We encourage others to evaluate and test this approach with other questionnaires and patient populations. The development and use of mPROMs has the potential to expand our ability to accurately capture PROs in limited literacy populations and promote equity in PRO measurement.
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Affiliation(s)
- Chao Long
- Curtis National Hand Center, MedStar Union Memorial Hospital, Baltimore, Maryland, United States of America
- Department of Plastic and Reconstructive Surgery, Johns Hopkins Medicine, Baltimore, Maryland, United States of America
| | - Laura K. Beres
- Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
| | - Albert W. Wu
- Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
| | - Aviram M. Giladi
- Curtis National Hand Center, MedStar Union Memorial Hospital, Baltimore, Maryland, United States of America
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Hanley AW, Gililland J, Erickson J, Pelt C, Peters C, Rojas J, Garland EL. Brief preoperative mind-body therapies for total joint arthroplasty patients: a randomized controlled trial. Pain 2021; 162:1749-1757. [PMID: 33449510 PMCID: PMC8119303 DOI: 10.1097/j.pain.0000000000002195] [Citation(s) in RCA: 37] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/17/2020] [Accepted: 12/08/2020] [Indexed: 12/16/2022]
Abstract
ABSTRACT Although knee and hip replacements are intended to relieve pain and improve function, up to 44% of knee replacement patients and 27% of hip replacement patients report persistent postoperative joint pain. Improving surgical pain management is essential. We conducted a single-site, 3-arm, parallel-group randomized clinical trial conducted at an orthopedic clinic, among patients undergoing total joint arthroplasty (TJA) of the hip or knee. Mindfulness meditation (MM), hypnotic suggestion (HS), and cognitive-behavioral pain psychoeducation (cognitive-behavioral pain psychoeducation) were each delivered in a single, 15-minute group session as part of a 2-hour, preoperative education program. Preoperative outcomes-pain intensity, pain unpleasantness, pain medication desire, and anxiety-were measured with numeric rating scales. Postoperative physical functioning at 6-week follow-up was assessed with the Patient-Reported Outcomes Measurement Information System Physical Function computer adaptive test. Total joint arthroplasty patients were randomized to preoperative MM, HS, or cognitive-behavioral pain psychoeducation (n = 285). Mindfulness meditation and HS led to significantly less preoperative pain intensity, pain unpleasantness, and anxiety. Mindfulness meditation also decreased preoperative pain medication desire relative to cognitive-behavioral pain psychoeducation and increased postoperative physical functioning at 6-week follow-up relative to HS and cognitive-behavioral pain psychoeducation. Moderation analysis revealed the surgery type did not differentially impact the 3 interventions. Thus, a single session of a simple, scripted MM intervention may be able to immediately decrease TJA patients' preoperative clinical symptomology and improve postoperative physical function. As such, embedding brief MM interventions in surgical care pathways has the potential to improve surgical outcomes for the millions of patients receiving TJA each year.
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Affiliation(s)
- Adam W. Hanley
- Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah
- College of Social Work, University of Utah
| | - Jeremy Gililland
- University of Utah Department of Orthopaedic Surgery
- Salt Lake City Veterans Affairs Medical Center
| | - Jill Erickson
- University of Utah Department of Orthopaedic Surgery
| | | | | | - Jamie Rojas
- Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah
- College of Social Work, University of Utah
| | - Eric L. Garland
- Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah
- College of Social Work, University of Utah
- Salt Lake City Veterans Affairs Medical Center
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Lokhorst MM, Horbach SER, Young-Afat DA, Stor MLE, Haverman L, Spuls PI, van der Horst CMAM. Development of a condition-specific patient-reported outcome measure for measuring symptoms and appearance in vascular malformations: the OVAMA questionnaire. Br J Dermatol 2021; 185:797-803. [PMID: 33937977 PMCID: PMC8518089 DOI: 10.1111/bjd.20429] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/28/2021] [Indexed: 12/16/2022]
Abstract
Background The symptoms and appearance of vascular malformations can severely harm a patient’s quality of life. The aim of treatment of vascular malformations generally is to improve condition‐specific symptoms and/or appearance. Therefore, it is highly important to start testing treatment effects in clinical studies from the patient’s perspective. Objectives To develop a patient‐reported outcome measure for measuring symptoms and appearance in patients with vascular malformations. Methods A first draft of the patient‐reported outcome measure was based on the previously internationally developed core outcome set. The qualitative part of this study involved interviews with 14 patients, which led to a second draft. The second draft was field tested cross‐sectionally, after which groups of items were evaluated for adequate internal consistency (Cronbach’s alpha > 0·7) to form composite scores. Construct validity was evaluated by testing 13 predefined hypotheses on known‐group differences. Results The patient interviews ensured adequate content validity and resulted in a general symptom scale with six items, a head and neck symptom scale with eight items, and an appearance scale with nine items. Cronbach’s alpha was adequate for two composite scores: a general symptom score (0·88) and an appearance score (0·85). Ten out of 13 hypotheses on known‐group differences were confirmed, confirming adequate construct validity. Conclusions With the development of the OVAMA questionnaire, outcomes of patients with vascular malformations can now be evaluated from the patient’s perspective. This may help improve the development of evidence‐based treatments and the overall care for patients with vascular malformations. What is already known about this topic?
The symptoms and appearance of vascular malformations may severely impact the patient’s physical, mental and social functioning. Condition‐specific symptoms and appearance are the main drivers for treatment of vascular malformations. Symptoms and appearance were determined to be core outcome domains and should be measured in all clinical research on vascular malformations. No instrument exists for measuring patient‐reported symptoms and appearance problems in vascular malformations. Vascular malformation research is hampered by heterogeneity in outcome measures. What does this study add?
With this study, a condition‐specific patient‐reported outcome measure was developed for measuring symptoms and appearance in patients with vascular malformations: the OVAMA questionnaire. This study confirms adequate content and construct validity. What are the clinical implications of this work?
The problems that matter most to patients with vascular malformations can now be evaluated from the patient’s perspective. Treatments can be evaluated and compared for effects on these core outcome domains. This study is a big step in tackling current heterogeneity in outcome measures. Clinically distinct groups can be determined based on disease severity. The many applications of the OVAMA questionnaire may significantly improve research and, ultimately, the care for patients with vascular malformations. Linked Comment: J. Tan. Br J Dermatol 2021; 185:695–696.
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Affiliation(s)
- M M Lokhorst
- Department of Plastic, Reconstructive and Hand Surgery, Amsterdam University Medical Centers, Amsterdam, the Netherlands
| | - S E R Horbach
- Department of Plastic, Reconstructive and Hand Surgery, Amsterdam University Medical Centers, Amsterdam, the Netherlands
| | - D A Young-Afat
- Department of Plastic, Reconstructive and Hand Surgery, Amsterdam University Medical Centers, Amsterdam, the Netherlands
| | - M L E Stor
- Department of Plastic, Reconstructive and Hand Surgery, Amsterdam University Medical Centers, Amsterdam, the Netherlands
| | - L Haverman
- Psychosocial Department, Emma Children's Hospital, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands
| | - P I Spuls
- Department of Dermatology, Amsterdam University Medical Centers, University of Amsterdam and Amsterdam Public Health, Infection and Immunity, Amsterdam, the Netherlands
| | - C M A M van der Horst
- Department of Plastic, Reconstructive and Hand Surgery, Amsterdam University Medical Centers, Amsterdam, the Netherlands
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Saygin D, Oddis CV, Dzanko S, Koontz D, Moghadam-Kia S, Ardalan K, Coles TM, Aggarwal R. Utility of patient-reported outcomes measurement information system (PROMIS) physical function form in inflammatory myopathy. Semin Arthritis Rheum 2021; 51:539-546. [PMID: 33894634 DOI: 10.1016/j.semarthrit.2021.03.018] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/04/2021] [Revised: 03/15/2021] [Accepted: 03/31/2021] [Indexed: 11/27/2022]
Abstract
OBJECTIVE Idiopathic inflammatory myopathies (IIM) are a group of diseases characterized by muscle weakness, which limit activities of daily living. Patient Reported Outcomes Measurement Information System (PROMIS) is a set of outcome measures developed using NIH funding, but has not yet been studied in adult IIM. Currently, the most commonly used PROs in IIM are Health Assessment Questionnaire (HAQ-DI) and SF-36 physical function-10 (PF10), both of which have several limitations. In this study, we investigated psychometric properties of PROMIS physical function-20 (PF-20) and compared to HAQ-DI and SF-36 PF10. METHODS Patients with IIM completed PROMIS PF-20 and six myositis core set measures [manual muscle testing (MMT), physician (MD-GDA), patient (PT-GDA) and extra-muscular global disease activity, HAQ-DI and creatine kinase], SF-36 PF10 and functional tests [six-minute walk, timed up-and-go and sit-to-stand tests] at monthly visits over 6-months. Total improvement score (TIS) using 2016 ACR/EULAR myositis response criteria was obtained as measures of change. RESULTS Fifty patients [mean age, 51.6; 60% females] were enrolled; 6 PM, 24 DM, 9 NM and 11 with AS. PROMIS PF-20 showed strong test-retest reliability when repeated in 1-month. PROMIS PF-20 had moderate-strong correlations with MD-GDA, PT-GDA, MMT, HAQ-DI, SF-36 PF10, and functional tests indicating good convergent validity. Change in PROMIS PF-20 strongly correlated with TIS demonstrating good responsiveness. HAQ-DI and SF-36 PF10 exhibited similar validity and responsiveness; HAQ-DI was found to have a ceiling effect. CONCLUSION PROMIS PF-20 demonstrates favorable psychometric properties in a large cohort of myositis patients and offers distinct advantages.
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Affiliation(s)
- Didem Saygin
- Division of Rheumatology, University of Chicago, Chicago, IL, United States
| | - Chester V Oddis
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh Medical Center, BST S 727, 3500 Terrace Street Pittsburgh, PA 15261, United States
| | - Sedin Dzanko
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh Medical Center, BST S 727, 3500 Terrace Street Pittsburgh, PA 15261, United States
| | - Diane Koontz
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh Medical Center, BST S 727, 3500 Terrace Street Pittsburgh, PA 15261, United States
| | - Siamak Moghadam-Kia
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh Medical Center, BST S 727, 3500 Terrace Street Pittsburgh, PA 15261, United States
| | - Kaveh Ardalan
- Department of Pediatrics, Division of Pediatric Rheumatology, Duke University School of Medicine, Durham, NC, United States; Departments of Pediatrics & Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Division of Rheumatology, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, United States
| | - Theresa M Coles
- Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States
| | - Rohit Aggarwal
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh Medical Center, BST S 727, 3500 Terrace Street Pittsburgh, PA 15261, United States.
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Wagner SC, Nassr A, Freedman BA, Elder BD, Bydon M, Sebastian AS. The Single Assessment Numeric Evaluation (SANE) after anterior cervical discectomy and fusion: A pilot study. J Clin Neurosci 2021; 88:95-101. [PMID: 33992211 DOI: 10.1016/j.jocn.2021.03.037] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2021] [Accepted: 03/19/2021] [Indexed: 11/29/2022]
Abstract
STUDY DESIGN Retrospective cohort. OBJECTIVES To evaluate the single assessment numerical evaluation (SANE) as a patient reported outcomes measure (PROM) after anterior cervical discectomy and fusion (ACDF), by comparing to legacy measures. METHODS We included all patients undergoing ACDF with at least one year of follow up with complete PROM data. Patients completed the Neck Disability Index (NDI), the RAND-36 and the EuroQual Five Dimension (EQ-5D) scale, as well as the one-question SANE, pre- and post-operatively. Validity of SANE compared with other PROMs was determined utilizing Pearson's correlation (ρ), proportional bias (B), responsiveness, minimal clinically important difference (MCID) and agreement. RESULTS Sixty-nine patients were included. There were moderate-to-strong correlations at a minimum of one-year follow-up between the SANE and NDI (ρ = -0.73, P < 0.0001), RAND (ρ = 0.80, P < 0.0001), and EQ-5D (ρ = -0.66, P < 0.0001). No significant proportional bias was found for the SANE when compared to the RAND (B = 0.03, p = 0.99), NDI (B = -0.003, p = 0.99), or EQ-5D (B = -0.0007, p = 0.99). Responsiveness for SANE was statistically similar to all other PROMs. The MCID for SANE was determined to be 10.5, with 42% of patients achieving the MCID. Bland-Altman plots demonstrated high agreement between all PROMs. CONCLUSION We found the SANE score provides clinically important patient outcomes data after ACDF, despite only requiring answering one question. The SANE performs comparably to more burdensome health questionnaires. The SANE score may offer spine surgeons the option to easily and quickly collect clinically relevant data on their surgical patients.
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Affiliation(s)
- Scott C Wagner
- Department of Orthopaedic Surgery, Walter Reed National Military Medical Center, Bethesda, MD, United States; Department of Surgery, The Uniformed Services University of the Health Sciences, Bethesda, MD, United States
| | - Ahmad Nassr
- Department of Orthopaedic Surgery, The Mayo Clinic, Rochester, MN, United States
| | - Brett A Freedman
- Department of Orthopaedic Surgery, The Mayo Clinic, Rochester, MN, United States
| | - Benjamin D Elder
- Department of Orthopaedic Surgery, The Mayo Clinic, Rochester, MN, United States
| | - Mohamad Bydon
- Department of Neurosurgery, The Mayo Clinic, Rochester, MN, United States
| | - Arjun S Sebastian
- Department of Orthopaedic Surgery, The Mayo Clinic, Rochester, MN, United States
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Parrish JM, Jenkins NW, Cha EDK, Lynch CP, Geoghegan CE, Mohan S, Jadczak CN, Matichak DP, Singh K. Patient-Reported Outcomes Measurement Information System Physical Function Validation for Use in Anterior Cervical Discectomy and Fusion: A 2-Year Follow-up Study. Neurospine 2021; 18:155-162. [PMID: 33819942 PMCID: PMC8021822 DOI: 10.14245/ns.2040458.229] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2020] [Accepted: 08/31/2020] [Indexed: 11/19/2022] Open
Abstract
Objective Our study aims to evaluate the correlation of Patient-Reported Outcomes Measurement Information System physical function (PROMIS PF) with legacy patient-reported outcome measures (PROMs) among patients undergoing anterior cervical discectomy and fusion (ACDF).
Methods A prospectively maintained database was retrospectively reviewed for ACDF surgeries performed between May 2015 and September 2017. Inclusion criteria were primary elective, single- or multilevel ACDFs for degenerative spinal pathology. Patients lacking preoperative or 2-year PROMIS PF surveys were excluded. Mean scores were calculated for visual analogue scale (VAS) neck, VAS arm, Neck Disability Index (NDI), 12-Item Short Form Physical Component Score (SF-12 PCS), and PROMIS PF at preoperative and 6-week, 12-week, 6-month, 1-year, and 2-year postoperative timepoints. A t-test and Pearson correlation coefficient were utilized to evaluate score improvement and PROM relationships respectively.
Results The 50 subject cohort was 60.0% male, 50% obese (body mass index ≥ 30 kg/m2) and had an average age of 50.9 years. Significant improvements were demonstrated for VAS neck and NDI at all postoperative timepoints (p < 0.001) and for SF-12 and PROMIS PF at all timepoints except 6 weeks (p ≤ 0.025). VAS arm improvement was seen up to 1 year (p ≤ 0.016). PROMIS PF demonstrated strong correlations with NDI and SF-12 PCS at all evaluated timepoints and with VAS neck at all postoperative timepoints except 6 weeks (all p < 0.01).
Conclusion PROMIS PF was strongly correlated with pain, disability, and physical function up to 2 years for patients undergoing ACDF. Our results support the long-term validity of PROMIS PF for measurement of patient-reported physical function among ACDF cohorts.
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Affiliation(s)
- James M Parrish
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA
| | - Nathaniel W Jenkins
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA
| | - Elliot D K Cha
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA
| | - Conor P Lynch
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA
| | - Cara E Geoghegan
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA
| | - Shruthi Mohan
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA
| | - Caroline N Jadczak
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA
| | | | - Kern Singh
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA
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Beaumont JL, Davis ES, Curtis JR, Cella D, Yun H. Meaningful Change Thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Pain Interference Scores in Patients With Rheumatoid Arthritis. J Rheumatol 2021; 48:1239-1242. [PMID: 33722955 DOI: 10.3899/jrheum.200990] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/24/2021] [Indexed: 01/12/2023]
Abstract
OBJECTIVE We estimated meaningful change thresholds (MCTs) for Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Pain Interference in rheumatoid arthritis (RA). METHODS The responsiveness of several patient-reported outcomes (PROs) was assessed among 521 patients with RA in the Arthritis, Rheumatism, and Aging Medical Information Systems (ARAMIS) cohort. PROMIS Fatigue (7-item) and Pain Interference (6-item) short form instruments were administered at baseline, 6 months, and 12 months. Self-reported retrospective changes over the previous 6 months (a lot better/worse, a little better/worse, stayed the same) were obtained at 6 and 12 months' follow-up. We estimated MCTs using the mean change in PROMIS scores for patients who rated their change "a little better" or "a little worse." RESULTS Baseline fatigue and pain interference scores were near normal (median 54 and 56, respectively). At 6 months, 7.9% of patients reported their fatigue was a little better compared to baseline (mean change [SD]: -2.6 [4.8]) and 22.8% a little worse (1.7 [5.6]). Pain was a little better for 11.5% of patients (-1.9 [6.1]) and a little worse for 24.2% of patients (0.6 [5.7]). At 12 months, results were similar. Thus, the MCT range was 1-2 points for both fatigue and pain interference. Correlations between change scores and retrospective ratings were low (0.13-0.29), indicating possible underestimation of MCT. CONCLUSION The group-level MCT for PROMIS Fatigue and Pain Interference is roughly 2-3 points and corresponds to a small effect size, which is consistent with earlier work demonstrating an MCT of 2 points for PROMIS Physical Functioning.
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Affiliation(s)
| | - Elizabeth S Davis
- E.S. Davis, MS, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama
| | - Jeffrey R Curtis
- J.R. Curtis, MD, MS, MPH, Division of Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama
| | - David Cella
- D. Cella, PhD, Northwestern University Feinberg School of Medicine, Chicago, Illinois
| | - Huifeng Yun
- H. Yun, PhD, Department of Epidemiology, and Division of Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
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Smit EB, Bouwstra H, Roorda LD, van der Wouden JHC, Wattel ELM, Hertogh CMPM, Terwee CB. A Patient-Reported Outcomes Measurement Information System Short Form for Measuring Physical Function During Geriatric Rehabilitation: Test-Retest Reliability, Construct Validity, Responsiveness, and Interpretability. J Am Med Dir Assoc 2021; 22:1627-1632.e1. [PMID: 33640312 DOI: 10.1016/j.jamda.2021.01.079] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/06/2020] [Revised: 01/20/2021] [Accepted: 01/24/2021] [Indexed: 01/06/2023]
Abstract
OBJECTIVES To study the test-retest reliability and measurement error, construct validity, responsiveness, interpretability, and floor/ceiling effects of a Patient-Reported Outcomes Measurement Information System (PROMIS) short form designed to measure physical function in geriatric rehabilitation patients (PROMIS-PF-GR). DESIGN Prospective cohort. SETTING AND PARTICIPANTS Inpatient geriatric rehabilitation patients. METHODS We evaluated the test-retest reliability by re-administering PROMIS-PF-GR 3 to 5 days after the admission measurement. The intraclass correlation coefficient (ICC) was calculated to determine test-retest reliability; an ICC of ≥0.70 was considered sufficient. Measurement error was established by calculating the standard error of measurement and smallest detectable change. Construct validity and responsiveness were determined by testing a priori formulated hypotheses (criterion: ≥75% hypothesis not rejected). Interpretability was evaluated by calculating the minimal important change using predictive modeling and a global rating as criterion for change. Floor/ceiling effects were established by calculating the percentage patients with the minimum/maximum raw score (criterion: ≤15%) at admission and discharge. RESULTS A total of 207 patients participated in the study [mean ± standard deviation age (80 ± 8.3 years), 58% female]. More than one-half of patients (56%) reported to be improved during rehabilitation. The ICC was 0.79 (95% confidence interval 0.70-0.84), the standardized error of measurement was 3.8, and the smallest detectable change 10.6. None of the 4 hypotheses for construct validity were rejected; 2 out of 5 hypotheses for responsiveness were rejected. The minimal important change was 8.0 (95% confidence interval 4.1-12.5). No floor/ceiling effects were found. CONCLUSIONS AND IMPLICATIONS The PROMIS-PG-GR showed sufficient test-retest reliability, measurement error, and construct validity. We did not find sufficient evidence for responsiveness, which may be due to the unexplained weak correlation between the PROMIS change score and the Global Rating Scale. We still recommend the use the PROMIS-PG-GR for measuring self-reported physical function in geriatric rehabilitation.
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Affiliation(s)
- Ewout B Smit
- Department of Medicine for Older People, Amsterdam Public Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
| | - Hylco Bouwstra
- Department of Medicine for Older People, Amsterdam Public Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
| | - Leo D Roorda
- Amsterdam Rehabilitation Research Center, Reade, Amsterdam, the Netherlands
| | - Johannes Hans C van der Wouden
- Department of Medicine for Older People, Amsterdam Public Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
| | - Elizabeth Lizette M Wattel
- Department of Medicine for Older People, Amsterdam Public Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
| | - Cees M P M Hertogh
- Department of Medicine for Older People, Amsterdam Public Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
| | - Caroline B Terwee
- Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
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Abma IL, Butje BJD, Ten Klooster PM, van der Wees PJ. Measurement properties of the Dutch-Flemish patient-reported outcomes measurement information system (PROMIS) physical function item bank and instruments: a systematic review. Health Qual Life Outcomes 2021; 19:62. [PMID: 33627157 PMCID: PMC7905571 DOI: 10.1186/s12955-020-01647-y] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/06/2020] [Accepted: 12/09/2020] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Limitations in physical functioning are a big concern especially for patients with chronic or musculoskeletal diseases. Therefore, physical functioning is often used as a core outcome of treatments. The generic patient-reported outcomes information system (PROMIS) physical function (PF) item bank has shown potential to measure PF with better precision, interpretability and lower respondent burden compared with traditional patient-reported outcome measures. This study provides an overview of the current evidence on the quality of the measurement properties of the translated Dutch-Flemish PROMIS-PF item bank and its subdomains, and their derived short forms and computer adaptive tests (CATs). METHODS PubMed was searched up to June 17th 2020 for validation studies of Dutch-Flemish PROMIS-PF in Dutch and Flemish adults. Quality assessment of the included studies was conducted using the COSMIN Risk of bias checklist. The COSMIN criteria for good measurement properties were used to judge the results of the studies, which were adjusted and added to where needed for this review, in the context of IRT instruments and item banks. The quality of evidence was summarized for each measurement property based on the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach. RESULTS Eleven studies were included, evaluating the PROMIS-PF item bank, the Upper Extremity (UE) subdomain, and/or their derived short forms and CATs in different clinical populations. There is evidence for sufficient structural validity, measurement precision, construct validity, and cross-cultural validity of the Dutch-Flemish PROMIS-PF item bank. The upper extremity subdomain item bank shows high quality evidence for structural validity and measurement precision. Content validity of these item banks has not been thoroughly demonstrated in a Dutch-Flemish population. Furthermore, the derived instruments have far less robust evidence: there are fewer validation studies available and none examined their performance as stand-alone administered instruments. CONCLUSIONS The first studies into the Dutch-Flemish PROMIS-PF item bank and the UE subdomain show promising results, with especially high quality evidence for sufficient structural validity and measurement precision. However, more studies, and with higher methodological quality, are needed to study the instruments derived from these item banks. These studies should also evaluate content validity, reliability and responsiveness.
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Affiliation(s)
- Inger L Abma
- Radboud University Medical Center, Radboud Institute of Health Sciences, IQ healthcare, Geert Grooteplein 21 (route 114), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
| | - Bas J D Butje
- Radboud University Medical Center, Radboud Institute of Health Sciences, IQ healthcare, Geert Grooteplein 21 (route 114), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands
| | - Peter M Ten Klooster
- Department of Psychology, Health, and Technology, Centre for eHealth and Well-Being Research, University of Twente, Enschede, The Netherlands
| | - Philip J van der Wees
- Radboud University Medical Center, Radboud Institute of Health Sciences, IQ healthcare, Geert Grooteplein 21 (route 114), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands
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Garcia LM, Birckhead BJ, Krishnamurthy P, Sackman J, Mackey IG, Louis RG, Salmasi V, Maddox T, Darnall BD. An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19. J Med Internet Res 2021; 23:e26292. [PMID: 33484240 PMCID: PMC7939946 DOI: 10.2196/26292] [Citation(s) in RCA: 112] [Impact Index Per Article: 28.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/23/2020] [Revised: 01/11/2021] [Accepted: 01/13/2021] [Indexed: 01/22/2023] Open
Abstract
BACKGROUND Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. OBJECTIVE We aimed to conduct a double-blind, parallel-arm, single-cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. METHODS A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between-within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. RESULTS The study sample was 179 adults (female: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ≥5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen d effect sizes ranged from 0.40 to 0.49, indicating superiority was moderately clinically meaningful. For EaseVRx, large pre-post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR. CONCLUSIONS EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand nonpharmacologic treatment for chronic low back pain. TRIAL REGISTRATION ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.2196/25291.
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Affiliation(s)
| | | | | | | | | | - Robert G Louis
- Division of Neurosurgery, Pickup Family Neurosciences Institute, Hoag Memorial Hospital, Newport Beach, CA, United States
| | - Vafi Salmasi
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, CA, United States
| | - Todd Maddox
- AppliedVR, Inc, Los Angeles, CA, United States
| | - Beth D Darnall
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, CA, United States
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Michalik AJ, Patel RK. Evaluation of transforaminal epidural steroid injections for discogenic axial lumbosacral back pain utilizing PROMIS as an outcome measure. Spine J 2021; 21:202-211. [PMID: 33091610 DOI: 10.1016/j.spinee.2020.10.018] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/24/2020] [Revised: 09/17/2020] [Accepted: 10/14/2020] [Indexed: 02/03/2023]
Abstract
BACKGROUND CONTEXT Discogenic lumbosacral back pain continues to present a challenging clinical entity with limited, controversial therapeutic options. No study to date has evaluated the efficacy of fluoroscopically guided transforaminal epidural steroid injections (TFESI) in a homogenous patient population with axial lumbosacral back pain from discogenic pathology utilizing strict, explicitly clinical and radiographic criteria. Additionally, there is a paucity of published data utilizing Patient Reported Outcome Measurement Information System (PROMIS) scores as an outcome measure for interventional spine procedures. PURPOSE Evaluate the therapeutic effect of TFESIs in a specific subset of patients with discogenic axial lumbosacral back pain. Investigate PROMIS as an outcome measure for interventional spine procedures targeting focal degenerative spinal pathology. STUDY DESIGN/SETTING Retrospective review of patients presenting to a multidisciplinary, tertiary academic spine center. PATIENT SAMPLE Three thousand eight hundred eighty-one patients were screened for inclusion. A total of 26 patients with discogenic axial low back, based on strict clinical and radiographic criteria, underwent TFESIs. All patients had axial low back pain without radicular pain, ≥3 clinical features of discogenic pain, corroborative radiographic features of active discogenic pathology on lumbar spine magnetic resonance imaging without confounding spinal pathology. OUTCOME MEASURES PROMIS Pain Interference (PI) v1.1, PROMIS Physical Function (PF) v1.2/v2.0, and PROMIS Depression (D) v1.0 outcome scores were collected at baseline and postprocedure follow-up. METHODS Query of an institutional, patient reported outcome database and subsequent retrospective review of electronic medical records was performed. Statistical analysis comparing baseline and postprocedural PROMIS outcome scores and correlation between these instruments was performed. Additionally, an exploratory investigation of minimal clinically important difference achievement rates was performed. RESULTS Analysis determined a statistically significant improvement in PROMIS PI (p=.017, 95% CI=-8.02 to -1.82) and PROMIS PF (p=.003, 95% CI=0.91-8.72) scores after treatment with TFESIs. At post treatment time points, TFESI had medium effect size on pain (d=0.55) and function (d=0.59). Change in PROMIS D scores (p=.488, 95% CI -1.74-3.54; d=.08) did not demonstrate statistical significance. Pearson correlation demonstrated a moderate negative correlation (r=-0.544, p=.004) between PROMIS PF with PROMIS PI. Correlation between PROMIS PF (r=-0.239, p=.24) and PROMIS PI (r=0.198, p=.33) with PROMIS D was not significant. Fourteen (53.8%) and 9 (34.6%) subjects achieved minimum clinically important difference (MCID) for PROMIS PI and PROMIS PF, respectively. Nine subjects (34.6%) achieved MCID for PROMIS D despite not otherwise reaching statistical significance otherwise. CONCLUSIONS Utilizing PROMIS as an outcome measure, discogenic axial lumbosacral back pain patients appear to benefit from TFESI in terms of pain and physical function. This study contributes to the growing body of literature utilizing PROMIS scores in patients with clinical sequelae of degenerative spinal pathology; however, prospective studies are needed.
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Affiliation(s)
- Adam J Michalik
- University of Utah School of Medicine, Division of Physical Medicine and Rehabilitation, Salt Lake City, UT, USA.
| | - Rajeev K Patel
- University of Rochester Medical Center, Department of Physical Medicine and Rehabilitation, Rochester, NY, USA
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Garcia LM, Darnall BD, Krishnamurthy P, Mackey IG, Sackman J, Louis RG, Maddox T, Birckhead BJ. Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc 2021; 10:e25291. [PMID: 33464215 PMCID: PMC7854039 DOI: 10.2196/25291] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/27/2020] [Revised: 11/28/2020] [Accepted: 12/08/2020] [Indexed: 01/23/2023] Open
Abstract
BACKGROUND Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. OBJECTIVE In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP). METHODS We will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology's novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data. RESULTS The study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. CONCLUSIONS Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain's societal burden. Our study could help shape future research and development of these innovative approaches. TRIAL REGISTRATION ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR1-10.2196/25291.
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Affiliation(s)
- Laura M Garcia
- Research and Development, AppliedVR Inc, Los Angeles, CA, United States.,USC Creative Media and Behavioral Health Center, Los Angeles, CA, United States
| | - Beth D Darnall
- Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, United States
| | | | - Ian G Mackey
- Research and Development, AppliedVR Inc, Los Angeles, CA, United States
| | - Josh Sackman
- Research and Development, AppliedVR Inc, Los Angeles, CA, United States
| | - Robert G Louis
- Division of Neurosurgery, Pickup Family Neurosciences Institute, Hoag Memorial Hospital, Newport Beach, CA, United States
| | - Todd Maddox
- Research and Development, AppliedVR Inc, Los Angeles, CA, United States
| | - Brandon J Birckhead
- Division of Health Services Research, Department of Medicine, Cedars-Sinai Health System, Los Angeles, CA, United States
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Is the Patient-Reported Outcome Measurement Information System Feasible in Bundled Payment for Care Improvement Total Knee Arthroplasty Patients? J Arthroplasty 2021; 36:6-12. [PMID: 32933798 DOI: 10.1016/j.arth.2020.07.041] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/06/2020] [Revised: 07/13/2020] [Accepted: 07/16/2020] [Indexed: 02/02/2023] Open
Abstract
BACKGROUND Several bundled payment plans, like the Bundled Payment for Care Improvement (BPCI) initiative for total joint arthroplasty, have been introduced to decrease costs and improve clinical care. Measuring clinical outcomes with efficient, standardized methodologies is essential to determine the relative value of total joint arthroplasty care. We investigated feasibility and responsiveness of the recently developed Patient-Reported Outcomes Measurement Information System (PROMIS) in total knee arthroplasty (TKA) patients. METHODS We included patients with preoperative and 1-year PROMIS Physical Function (PF), Pain Interference (PI), and Depression (DEP) scores who received unilateral primary TKA. Burden was assessed using the number of questions and time required for PROMIS completion. The minimum clinically important difference was defined as 5. Floor/ceiling effects were noted if more than 15% of patients responded with the lowest/highest possible score, respectively. Wilcoxon rank-sum test was used to compare categorical data. Analysis of variance was used for PROMIS comparisons. RESULTS In total, 172 knees (54 BPCI) were included. Floor effects were identified for DEP at baseline (non-BPCI) and follow-up (both groups), and for PI at follow-up only (BPCI). Patients required 140 seconds and 16 questions to answer all 3 PROMIS domains. Sixty-seven percent, 60%, and 44% of knees achieved minimum clinically important difference in PI, PF, and DEP scores respectively, with no significant difference between groups. The BPCI cohort was older (P < .001) with a higher American Society of Anesthesiologists score (P = .028). There were no significant differences in scores between BPCI and non-BPCI patients. CONCLUSION PROMIS is feasible and time-efficient in BPCI patients undergoing primary TKA. There were no significant differences in outcomes between BPCI and non-BPCI knees. LEVEL OF EVIDENCE Level III.
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Balachandran AT, Vigotsky AD, Quiles N, Mokkink LB, Belio MA, Glenn JM. Validity, reliability, and measurement error of a sit-to-stand power test in older adults: A pre-registered study. Exp Gerontol 2020; 145:111202. [PMID: 33347922 DOI: 10.1016/j.exger.2020.111202] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2020] [Revised: 11/23/2020] [Accepted: 12/08/2020] [Indexed: 10/22/2022]
Abstract
OBJECTIVES Lower body power declines with age and is associated with decreased physical function in older adults. However, the majority of the tools available to measure power are expensive and require considerable space and expertise to operate. The purpose of this study was to assess the validity, reliability, and measurement error of a sit-to-stand power test (STSp) to assess lower body power. METHODS 51 community-dwelling adults, 65 years or older, completed a power test using a pneumatic leg press (LP), the Short Physical Performance Battery (SPPB) that includes a test of balance, usual walking speed, and chair stand tests; Timed Up and Go (TUG) test at both usual and fast paces, and Patient-Reported Outcome Measures (PROMs). A two-week test-retest assessed the reliability in 36 participants. The study hypotheses and analysis were pre-registered prior to data collection and statistical analyses were blinded. RESULTS The mean age was 71.3 years, with 63% females, and an average SPPB score of 10.6 (median = 12). STSp peak power was strongly correlated with LP (r = 0.90, 95% CI (0.82, 0.94). As hypothesized, the STSp peak power showed similar or higher correlations with physical function tests relative to LP peak power: SPPB (0.41 vs. 0.29), chair stand test (-0.44 vs. -0.35), TUG test at usual pace (-0.37 vs. -0.29) and fast pace (-0.41 vs. -0.34) and balance (0.33 vs. 0.22), but not for mobility (0.34 vs. 0.38) and function (0.41 vs. 0.48) questionnaire. For discriminant validity, as hypothesized, males showed higher STSp peak power compared to females (Δ = 492 W, p < .001, Cohen's d = 2.0). Test-retest assessment yielded an intraclass correlation coefficient of 0.96 and a standard error of measurement of 70.4 W. No adverse events were reported or observed for both tests. CONCLUSION The STSp showed adequate validity and reliability in measuring lower body power in community-dwelling older adults. The test is quick, relatively inexpensive, safe, and portable and thus should be considered for use in aging research.
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Affiliation(s)
- Anoop T Balachandran
- Department of Family, Nutrition, and Exercise Sciences, Queens College, The City University of New York, Flushing, NY, United States of America.
| | - Andrew D Vigotsky
- Departments of Biomedical Engineering and Statistics, Northwestern University, Evanston, IL, United States of America
| | - Norberto Quiles
- Department of Family, Nutrition, and Exercise Sciences, Queens College, The City University of New York, Flushing, NY, United States of America
| | - Lidwine B Mokkink
- Amsterdam University Medical Centers, location VUmc, Department of Epidemiology and Data Science, Amsterdam Public Health research institute, Amsterdam, the Netherlands
| | - Mark A Belio
- Department of Family, Nutrition, and Exercise Sciences, Queens College, The City University of New York, Flushing, NY, United States of America
| | - Jordan McKenzie Glenn
- Exercise Science Research Center, Department of Health, Human Performance and Recreation, University of Arkansas, Fayetteville, AR, United States of America; Neurotrack Technologies, 399 Bradford St., Redwood City, CA, United States of America
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