1
|
Thimm A, Maskarinec G, Guillermo C, Nimptsch K, Pischon T. A systematic review of observational studies on the association between diet quality patterns and visceral adipose tissue. Br J Nutr 2024; 132:1530-1541. [PMID: 39529299 DOI: 10.1017/s000711452400179x] [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] [Indexed: 11/16/2024]
Abstract
Beyond obesity, visceral adipose tissue (VAT) has emerged as an important predictor of chronic disease, but the role of diet quality patterns (DQP) in VAT development is not well defined. Therefore, we conducted a systematic review of how various DQP are associated with VAT via literature searches in PubMed and EMBASE. We included observational investigations in disease-free adults/adolescents that related DQP to VAT assessed by imaging methods. The studies were evaluated separately for a priori and a posteriori DQP and according to design differences. Study quality was assessed using the Risk of Bias in Non-randomised Studies of Interventions tool. Of the 1807 screened articles, thirty-five studies met the inclusion criteria. The majority of a priori indices, for example, the Healthy Eating Index, showed significant inverse associations with VAT, while only a small proportion of a posteriori patterns were related to VAT. Results did not differ substantially by the method of exposure and outcome assessment or between studies with (n 20) or without (n 15) body-size adjustment, but significant findings were more common in younger v. older individuals, USA v. other populations and investigations with moderate v. serious risk of bias. The heterogeneity of the existing literature limited the ability to quantify the magnitude of the associations across studies. These findings suggest that a high-quality diet, as assessed by a priori DQP, is generally inversely associated with VAT, but results for a posteriori DQP are less consistent. As associations persisted after adjusting for body size, diet quality may beneficially influence VAT beyond its association with obesity.
Collapse
Affiliation(s)
- Annalena Thimm
- Max Delbrück Centrum für Molekulare Medizin, Berlin, Germany
| | - Gertraud Maskarinec
- Max Delbrück Centrum für Molekulare Medizin, Berlin, Germany
- University of Hawaii Cancer Center, Honolulu, HI, USA
| | | | | | - Tobias Pischon
- Max Delbrück Centrum für Molekulare Medizin, Berlin, Germany
| |
Collapse
|
2
|
Telles R, Whitney BM, Froelich S, Lutgendorf SK. Mindfulness-based psychosocial interventions and psychological wellbeing in cancer survivorship: a meta-analysis. Health Psychol Rev 2024; 18:723-749. [PMID: 38561221 PMCID: PMC11556419 DOI: 10.1080/17437199.2024.2336014] [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: 07/10/2023] [Accepted: 03/22/2024] [Indexed: 04/04/2024]
Abstract
PURPOSE Among cancer survivors, mindfulness-based interventions appear promising in decreasing distress for cancer patients, but little attention has been paid to the ultimate mindfulness goal of increasing psychological wellbeing. This meta-analysis aims to summarise and synthesise available evidence concerning the effectiveness of MBIs on positive psychological outcomes reflecting key aspects of psychological wellbeing in heterogeneous cancer patients. METHODS A literature search of mindfulness-based randomised clinical trials in cancer survivors was conducted across six electronic databases. Two reviewers independently screened studies and extracted data. Meta-analyses were conducted using R; standardised mean difference (SMD) was used to determine intervention effect. Moderators examined included therapeutic orientation, control group type, treatment modality, treatment target, heterogeneous vs. homogeneous cancer type, and facet of wellbeing. RESULTS Thirty-one studies were included (N = 2651). Those who received mindfulness-based interventions reported significantly higher eudaimonic, hedonic, and social wellbeing than respondents in control groups (SMD = 0.599). Interventions were equally effective across therapeutic orientation, control group type, treatment modality and treatment target. There were trend level differences favouring homogeneous cancer diagnosis groups over heterogeneous diagnosis groups. CONCLUSION MBIs provide an effective treatment for increasing psychological wellbeing in cancer survivors. This finding has important implications for clinical practice.
Collapse
Affiliation(s)
- Rachel Telles
- Department of Psychological & Brain Sciences, University of Iowa, Iowa City, IA
| | - Brendan M. Whitney
- Department of Psychological & Brain Sciences, University of Iowa, Iowa City, IA
| | - Sarah Froelich
- Department of Psychological & Brain Sciences, University of Iowa, Iowa City, IA
| | - Susan K. Lutgendorf
- Department of Psychological & Brain Sciences, University of Iowa, Iowa City, IA
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Iowa, Iowa City, IA
- Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA
| |
Collapse
|
3
|
Zhang Q, Liu Z, Wang T, Yu M, Li X. Efficacy and acceptability of adjunctive n-acetylcysteine for psychotic disorders: Systematic review and meta-analysis. Hum Psychopharmacol 2024; 39:e2880. [PMID: 37712506 DOI: 10.1002/hup.2880] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/05/2023] [Revised: 08/06/2023] [Accepted: 08/30/2023] [Indexed: 09/16/2023]
Abstract
INTRODUCTION N-acetylcysteine (NAC) augmentation of antipsychotic medication has been studied in psychotic disorders but the results are inconsistent. This meta-analysis aimed to evaluate the efficacy and acceptability of NAC as an augmentation strategy for psychotic disorders. METHODS PubMed, Web of Science, EMBASE, PsycINFO, Cochrane Library, and ClinicalTrials.gov were searched until the date of November 28, 2022. The inclusion criteria were randomized controlled trials (RCTs) comparing NAC and placebo in patients with psychotic disorders. The outcomes were the psychotic symptoms measured by the Positive and Negative Syndrome Scale (PANSS) and drop-out rates. RESULTS A total of 594 patients from eight trials were included. The results showed that no difference was found in score changes of PANSS total, positive, negative, or general psychopathology scale scores between the NAC group and placebo group in both time points (≤24 weeks and >24 weeks). There was also no statistical difference in drop-out rates between the two groups. CONCLUSION For the moment, it is not appropriate to recommend NAC as an augmentation of antipsychotic medication to treat psychotic disorders in routine clinical practice.
Collapse
Affiliation(s)
- Qun Zhang
- Department of Psychiatry, The Air Force Hospital of Northern Theater PLA, Shenyang, Liaoning, China
| | - Ziping Liu
- Department of Psychiatry, The Air Force Hospital of Northern Theater PLA, Shenyang, Liaoning, China
| | - Ting Wang
- Department of Psychiatry, The Air Force Hospital of Northern Theater PLA, Shenyang, Liaoning, China
| | - Min Yu
- Department of Critical Care Medicine, 920th Hospital of Joint Logistics Support Force, PLA, Kunming, Yunnan, China
| | - Xiaoqian Li
- Department of Psychiatry, The Air Force Hospital of Northern Theater PLA, Shenyang, Liaoning, China
| |
Collapse
|
4
|
Jeffery A, Walters K, Wong ICK, Osborn D, Hayes JF. The association between antidepressant treatment and rates of insulin initiation in comorbid depression and type 2 diabetes: A UK electronic health record nested case-control study. Diabetes Res Clin Pract 2024; 209:111083. [PMID: 38159576 DOI: 10.1016/j.diabres.2023.111083] [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: 08/30/2023] [Revised: 12/05/2023] [Accepted: 12/25/2023] [Indexed: 01/03/2024]
Abstract
AIMS To investigate the association between antidepressant prescribing and the rate of insulin initiation in type 2 diabetes. METHODS Using UK primary care records we completed a nested-case control study in a individuals with comorbid depression and type 2 diabetes. Cases were defined as individuals initiating insulin, controls were individuals remaining on oral antidiabetic medication. We used conditional logistic regression to estimate incident rate ratios (IRR) and the 95% confidence intervals (CI) for the association between antidepressant prescribing and initiating insulin. We adjusted for demographic characteristics, comorbidities, health service and previous medication use. RESULTS We included 11,862 cases who initiated insulin, and 43,452 controls. Increased rates of insulin initiation were associated with any antidepressant prescription (IRR 3.78, 95% CI 3.53-4.04), longer (24+ months) durations of antidepressant treatment (IRR 5.61, 95% CI 5.23-6.03), and higher numbers (3+) of different antidepressant agents prescribed (IRR 5.72, 95% CI 5.25-6.24). There was no difference between recent and non-recent antidepressant prescriptions, or between different antidepressant agents. CONCLUSIONS Antidepressant prescribing was highly associated with the initiation of insulin therapy. However, this may not indicate a direct causal effect of the antidepressant medication itself, and may be a marker of more severe depression influencing diabetic control.
Collapse
Affiliation(s)
- Annie Jeffery
- Epidemiology and Applied Clinical Research Department, Division of Psychiatry, University College London (UCL), London, United Kingdom.
| | - Kate Walters
- Department of Primary Care & Population Health, Institute of Epidemiology & Health, University College London (UCL), London, United Kingdom.
| | - Ian C K Wong
- Research Department of Practice and Policy, School of Pharmacy, University College London (UCL), London, United Kingdom; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
| | - David Osborn
- Epidemiology and Applied Clinical Research Department, Division of Psychiatry, University College London (UCL), London, United Kingdom.
| | - Joseph F Hayes
- Epidemiology and Applied Clinical Research Department, Division of Psychiatry, University College London (UCL), London, United Kingdom.
| |
Collapse
|
5
|
Grech V, Eldawlatly AA. STROBE, CONSORT, PRISMA, MOOSE, STARD, SPIRIT, and other guidelines - Overview and application. Saudi J Anaesth 2024; 18:137-141. [PMID: 38313708 PMCID: PMC10833025 DOI: 10.4103/sja.sja_545_23] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2023] [Accepted: 06/24/2023] [Indexed: 02/06/2024] Open
Abstract
The purpose of research is to seek answers and new knowledge. When conducted properly and systematically, research adds to humanity's corpus of knowledge and hence to our general advancement. However, this is only possible if reported research is accurate and transparent. Guidelines for all the major types of studies (STROBE, CONSORT, PRISMA, MOOSE, STARD, and SPIRIT) have been developed and refined over the years, and their inception, development, and application are briefly discussed in this paper. Indeed, there are currently over 250 of these guidelines for various types of medical research, and these are published by the EQUATOR network. This paper will also briefly review progress in acceptance and adoption of these guidelines.
Collapse
Affiliation(s)
- Victor Grech
- Consultant Paediatrician (Cardiology), Mater Dei Hospital, Malta
| | | |
Collapse
|
6
|
Vicente-Oliveros N, Gramage-Caro T, Corral de la Fuente E, Delgado-Silveira E, Álvarez-Díaz AM. Analysis of adverse drug events as a way to improve cancer patient care. Eur J Hosp Pharm 2023; 31:27-30. [PMID: 35332064 PMCID: PMC10800239 DOI: 10.1136/ejhpharm-2021-003199] [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: 12/28/2021] [Accepted: 03/08/2022] [Indexed: 11/04/2022] Open
Abstract
PURPOSE To define the signals that a new artificial intelligence (AI) system must emit to improve adverse drug events (ADEs) management in oral antineoplastic agents (OAA). METHODS A multidisciplinary group of experts in patient safety was set up to define what signals the new AI system must emit to improve ADEs management in OAAs. The baseline data for the new AI system were generated through an observational and ambispective study carried out in a university hospital. All patients who met the inclusion criteria were selected consecutively every working day for 6 months. The ADEs were collected by interview and by the review of health records. The ADEs were categorised according to how they could be detected: patient, analysis, examination. RESULTS The group defined what signals the AI system must emit to improve ADEs management in OAAs: a signal to educate the patient when the possible ADEs were categorised as patient, a signal as a reminder to request a blood test or a microbiological culture when the possible ADEs were categorised as analysis, and a signal as a reminder for the necessity of a clinical examination when the possible ADEs were categorised as examination. A total of 1652 ADEs were reported in the interviews (ADE-interview) with the pharmacist, and doctors noted 1989 ADEs in the health record (ADE-HR). The most frequent ADEs were identified in the patient category. CONCLUSION This study opens a new way for better management of ADEs and is the first step in the development of a future technology, which will improve the quality of life of patients.
Collapse
Affiliation(s)
| | | | - Elena Corral de la Fuente
- Early Phase Clinical Drug Development in Oncology, South Texas Accelerated Research Therapeutics (START). Centro Integral Oncológico Clara Campal (CIOCC), Madrid, Spain
| | | | | |
Collapse
|
7
|
Engström I, Hansson L, Ali L, Berg J, Ekstedt M, Engström S, Fredriksson MK, Liliemark J, Lytsy P. Relational continuity may give better clinical outcomes in patients with serious mental illness - a systematic review. BMC Psychiatry 2023; 23:952. [PMID: 38110889 PMCID: PMC10729558 DOI: 10.1186/s12888-023-05440-1] [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: 07/20/2023] [Accepted: 12/05/2023] [Indexed: 12/20/2023] Open
Abstract
BACKGROUND Continuity of care is considered important for results of treatment of serious mental illness (SMI). Yet, evidence of associations between relational continuity and different medical and social outcomes is sparse. Research approaches differ considerably regarding how to best assess continuity as well as which outcome to study. It has hitherto been difficult to evaluate the importance of relational continuity of care. The aim of this systematic review was to investigate treatment outcomes, including effects on resource use and costs associated with receiving higher relational continuity of care for patients with SMI. METHODS Eleven databases were searched between January 2000 and February 2021 for studies investigating associations between some measure of relational continuity and health outcomes and costs. All eligible studies were assessed for study relevance and risk of bias by at least two independent reviewers. Only studies with acceptable risk of bias were included. Due to study heterogeneity the synthesis was made narratively, without meta-analysis. The certainty of the summarized result was assessed using GRADE. Study registration number in PROSPERO: CRD42020196518. RESULTS We identified 8 916 unique references and included 17 studies comprising around 300 000 patients in the review. The results were described with regard to seven outcomes. The results indicated that higher relational continuity of care for patients with serious mental illness may prevent premature deaths and suicide, may lower the number of emergency department (ED) visits and may contribute to a better quality of life compared to patients receiving lower levels of relational continuity of care. The certainty of the evidence was assessed as low or very low for all outcomes. The certainty of results for the outcomes hospitalization, costs, symptoms and functioning, and adherence to drug treatment was very low with the result that no reliable conclusions could be drawn in these areas. CONCLUSIONS The results of this systematic review indicate that having higher relational continuity of care may have beneficial effects for patients with severe mental illness, and no results have indicated the opposite relationship. There is a need for better studies using clear and distinctive measures of exposure for relational continuity of care.
Collapse
Affiliation(s)
- Ingemar Engström
- University Health Care Center, Faculty of Medicine and Health, Örebro University, Örebro, SE-701 82, Sweden.
| | - Lars Hansson
- Department of Health Sciences, Lund University, Lund, Sweden
| | - Lilas Ali
- Institute of Health and Care Sciences, University of Gothenburg, Gothenburg, Sweden
| | - Jenny Berg
- SBU - Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm, Sweden
| | - Mirjam Ekstedt
- Department of Health and Caring Sciences, Linnaeus University, Kalmar, Sweden
| | | | - Maja Kärrman Fredriksson
- SBU - Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm, Sweden
| | - Jan Liliemark
- SBU - Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm, Sweden
| | - Per Lytsy
- SBU - Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm, Sweden
| |
Collapse
|
8
|
Sabaté M, Montané E. Pharmacoepidemiology: An Overview. J Clin Med 2023; 12:7033. [PMID: 38002647 PMCID: PMC10672708 DOI: 10.3390/jcm12227033] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/28/2023] [Revised: 11/04/2023] [Accepted: 11/08/2023] [Indexed: 11/26/2023] Open
Abstract
The aims of this review are to provide a comprehensive overview of the definition and scope of pharmacoepidemiology, to summarize the study designs and methodologies used in the field, to discuss the future trends in the field and new methodologies to address bias and confounding, and finally to give some recommendations to clinicians interested in pharmacoepidemiologic research. Because drug efficacy and safety from randomized clinical trials do not reflect the real-world situation, pharmacoepidemiological studies on drug safety monitoring and drug effectiveness in large numbers of people are needed by healthcare professionals and regulatory institutions. We aim to highlight the importance of pharmacoepidemiologic research in informing evidence-based medicine and public health policy. The development of new designs and methodologies for the generation of valid evidence, as well as new initiatives to provide guidance and recommendations on how to incorporate real-world evidence into the drug development process, are reported on. In addition, we have touched on the implication of artificial intelligence in the management of real-world data. This overview aims to summarize all important aspects to consider when conducting or interpreting a pharmacoepidemiologic study.
Collapse
Affiliation(s)
- Mònica Sabaté
- Department of Clinical Pharmacology, Hospital Universitari Vall d’Hebron, Clinical Pharmacology Research Group, Vall d’Hebron Research Institute, 08035 Barcelona, Spain;
- Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain
| | - Eva Montané
- Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain
- Department of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol, 08916 Badalona, Spain
| |
Collapse
|
9
|
Davies L, Hankey BF, Wang Z, Zou Z, Scott S, Lee M, Cho H, Feuer EJ. Key Points for Clinicians About the SEER Oral Cancer Survival Calculator. JAMA Otolaryngol Head Neck Surg 2023; 149:1042-1046. [PMID: 37429019 DOI: 10.1001/jamaoto.2023.1977] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 07/12/2023]
Abstract
Importance In the setting of a new cancer diagnosis, the focus is usually on the cancer as the main threat to survival, but people may have other conditions that pose an equal or greater threat to their life than their cancer: a competing risk of death. This is especially true for patients who have cancer of the oral cavity, because prolonged exposure to alcohol and tobacco are risk factors for cancer in this location but also can result in medical conditions with the potential to shorten life expectancy, competing as a cause of death that may intervene in conjunction with or before the cancer. Observations A calculator designed for public use has been released that allows patients age 20 to 86 years who have a newly diagnosed oral cancer to obtain estimates of their health status-adjusted age, life expectancy in the absence of the cancer, and probability of surviving, dying of the cancer, or dying of other causes within 1 to 10 years after diagnosis. The models in the calculator showed that patients with oral cavity cancer had a higher than average risk of death from other causes than the matched US population, and this risk increases by stage. Conclusions and Relevance The Surveillance, Epidemiology and End Results Program Oral Cancer Survival Calculator supports a holistic approach to the life of the patient, and the risk of death of other causes is treated equally to consideration of the probability of death of the cancer. This tool may be usefully paired with the other available prognostic calculators for oral cancer and is an example of the possibilities now available with registry linkages to partially overlapping or independent data sets and statistical techniques that allow the use of 2 time scales in 1 analysis.
Collapse
Affiliation(s)
- Louise Davies
- VA Outcomes Group, US Department of Veterans Affairs Medical Center, White River Junction, Vermont
- Section of Otolaryngology at the Geisel School of Medicine at Dartmouth, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire
| | - Benjamin F Hankey
- Statistical Research and Application Branch, Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, Maryland
| | - Zhuoqiao Wang
- Information Management Services, Inc, Calverton, Maryland
| | - Zhaohui Zou
- Information Management Services, Inc, Calverton, Maryland
| | - Susan Scott
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, Maryland
| | - Minjung Lee
- Department of Statistics, Kangwon National University, Chuncheon, Gangwon, Korea
| | - Hyunsoon Cho
- Department of Cancer AI and Digital Health, National Cancer Center Graduate School of Cancer Science and Policy and the Integrated Biostatistics Branch, Division of Cancer Data Science, National Cancer Center, Goyang, Gyeonggi-do, Korea
| | - Eric J Feuer
- Statistical Research and Application Branch, Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, Maryland
| |
Collapse
|
10
|
Plöderl M, Amendola S, Hengartner MP. Observational studies of antidepressant use and suicide risk are selectively published in psychiatric journals. J Clin Epidemiol 2023; 162:10-18. [PMID: 37544615 DOI: 10.1016/j.jclinepi.2023.07.015] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/03/2023] [Revised: 07/15/2023] [Accepted: 07/24/2023] [Indexed: 08/08/2023]
Abstract
OBJECTIVES To investigate if observational studies showing favorable results for antidepressants on suicidal behavior (reduced risk) are preferably and more easily published in psychiatric journals and cited more often compared to studies with unfavorable results (increased risk). STUDY DESIGN AND SETTING Prespecified secondary analysis, including 27 original studies selected through a systematic review of observational studies reporting associations between the use of newer antidepressant drugs and suicide risk. RESULTS Independent of study quality, studies reporting favorable results were more frequently published in psychiatric than nonpsychiatric journals and were more often conducted by lead authors with financial conflicts of interest (fCOI). Within psychiatric journals, lead authors with fCOI published in journals with a higher impact factor (IF) and ranking. Within psychiatric journals, favorability of results also correlated with citation frequency, IF, and journal ranking, but these associations became weaker and inconclusive after adjusting for study quality. Results for ease of publishing were inconclusive. CONCLUSION Studies reporting unfavorable results (increased suicide risk with antidepressant exposure) are less likely to be published in psychiatric journals. Lead authors with fCOI report more favorable results, and their studies are published in the most prestigious psychiatric journals. This may create a biased evidence base and an unbalanced dissemination and appraisal of findings within psychiatry.
Collapse
Affiliation(s)
- Martin Plöderl
- Department of Inpatient Psychotherapy and Crisis Intervention, University Clinic for Psychiatry, Psychotherapy, and Psychosomatics, Christian Doppler Clinic, Paracelsus Medical University, Salzburg, Austria
| | - Simone Amendola
- Department of Applied Psychology, Zurich University of Applied Sciences, Zurich, Switzerland
| | | |
Collapse
|
11
|
Scheefhals ZTM, de Vries EF, Molenaar JM, Numans ME, Struijs JN. Observational Data for Integrated Maternity Care: Experiences with a Data-Infrastructure for Parents and Children in the Netherlands. Int J Integr Care 2023; 23:20. [PMID: 38145057 PMCID: PMC10742107 DOI: 10.5334/ijic.7012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2022] [Accepted: 11/30/2023] [Indexed: 12/26/2023] Open
Abstract
Introduction Observational data are increasingly seen as a valuable source for integrated care research. Especially since the growing availability of routinely collected data and quasi-experimental methods. The aim of this paper is to describe the potentials and challenges when using observational data for integrated maternity care research, based on our experience from developing and working with the Data-InfrAstructure for ParEnts and childRen (DIAPER). Methods and Results We provide a description of DIAPER, which is a linked data-infrastructure on the individual level based on maternity care claims data, quality and utilization of maternity care and data from municipal registries, covering the life course from preconception to adulthood. We then discuss potentials and practical applications of DIAPER such as to evaluate alternative payment models for integrated maternity care, to set the policy agenda regarding postpartum care, to provide insights into value of care and into provider variation, and to evaluate (policy) interventions designed to promote and support integrated maternity care. This is relevant for several stakeholders: policy makers, payers, providers and clients/patients. Based on experiences with DIAPER, we identify remaining challenges: missing data sources (especially self-reported outcomes), suboptimal quality of data, privacy concerns and potential biases introduced during data linkage, and describe how these challenges were tackled within the applications of DIAPER. Conclusions With DIAPER we demonstrated that using observational data can be of added value for integrated care research, but also that challenges remain. It is essential to keep exploring and developing the possibilities of observational data and continue the discussions in the scientific community. Learning from each other's successes and failures will be critical.
Collapse
Affiliation(s)
- Zoë T. M. Scheefhals
- Department of National Health and Healthcare, National Institute for Public Health and the Environment (RIVM), The Netherlands
- Department of Public Health and Primary Care, LUMC Health Campus The Hague, The Netherlands
| | - Eline F. de Vries
- Department of Health Economics and Healthcare, National Institute for Public Health and the Environment (RIVM), The Netherlands
| | - Joyce M. Molenaar
- Department of National Health and Healthcare, National Institute for Public Health and the Environment (RIVM), The Netherlands
- Department of Public Health and Primary Care, LUMC Health Campus The Hague, The Netherlands
| | - Mattijs E. Numans
- Department of Public Health and Primary Care, LUMC Health Campus The Hague, The Netherlands
| | - Jeroen N. Struijs
- Department of National Health and Healthcare, National Institute for Public Health and the Environment (RIVM), The Netherlands
- Department of Public Health and Primary Care, LUMC Health Campus The Hague, The Netherlands
| |
Collapse
|
12
|
Catarci M, Guadagni S, Masedu F, Ruffo G, Viola MG, Borghi F, Baldazzi G, Scatizzi M. Three-row versus two-row circular staplers for left-sided colorectal anastomosis: a propensity score-matched analysis of the iCral 2 and 3 prospective cohorts. Int J Surg 2023; 109:2312-2323. [PMID: 37195782 PMCID: PMC10442086 DOI: 10.1097/js9.0000000000000480] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/08/2023] [Accepted: 05/08/2023] [Indexed: 05/18/2023]
Abstract
BACKGROUND Since most anastomoses after left-sided colorectal resections are performed with a circular stapler, any technological change in stapling devices may influence the incidence of anastomotic adverse events. The aim of the present study was to analyze the effect of a three-row circular stapler on anastomotic leakage and related morbidity after left-sided colorectal resections. MATERIALS AND METHODS A circular stapled anastomosis was performed in 4255 (50.9%) out of 8359 patients enrolled in two prospective multicenter studies in Italy, and, after exclusion criteria to reduce heterogeneity, 2799 (65.8%) cases were retrospectively analyzed through a 1:1 propensity score-matching model including 20 covariates relative to patient characteristics, to surgery and to perioperative management. Two well-balanced groups of 425 patients each were obtained: group (A) - true population of interest, anastomosis performed with a three-row circular stapler; group (B) - control population, anastomosis performed with a two-row circular stapler. The target of inferences was the average treatment effect in the treated (ATT). The primary endpoints were overall and major anastomotic leakage and overall anastomotic bleeding; the secondary endpoints were overall and major morbidity and mortality rates. The results of multiple logistic regression analyses for the outcomes, including the 20 covariates selected for matching, were presented as odds ratios (OR) and 95% confidence intervals (95% CI). RESULTS Group A versus group B showed a significantly lower risk of overall anastomotic leakage (2.1 vs. 6.1%; OR 0.33; 95% CI 0.15-0.73; P =0.006), major anastomotic leakage (2.1 vs. 5.2%; OR 0.39; 95% CI 0.17-0.87; P =0.022), and major morbidity (3.5 vs. 6.6% events; OR 0.47; 95% CI 0.24-0.91; P =0.026). CONCLUSION The use of three-row circular staplers independently reduced the risk of anastomotic leakage and related morbidity after left-sided colorectal resection. Twenty-five patients were required to avoid one leakage.
Collapse
Affiliation(s)
- Marco Catarci
- General Surgery Unit, Sandro Pertini Hospital, ASL Roma 2, Rome
- General Surgery Unit, “C.&G. Mazzoni” Hospital, Ascoli Piceno
| | | | - Francesco Masedu
- Department of Applied Clinical Sciences and Biotechnology, University of L’Aquila, L’Aquila
| | - Giacomo Ruffo
- General Surgery Unit, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella (VR)
| | - Massimo G. Viola
- General Surgery Unit, Cardinale G. Panico Hospital, Tricase (LE)
| | - Felice Borghi
- Oncologic Surgery Unit, Candiolo Cancer Institute, FPO-IRCCS, Candiolo (TO)
- General & Oncologic Surgery Unit, Department of Surgery, Santa Croce e Carle Hospital, Cuneo
| | - Gianandrea Baldazzi
- General Surgery Unit, ASST Ovest Milanese, Legnano (MI)
- General Surgery Unit, ASST Nord Milano, Sesto San Giovanni (MI)
| | - Marco Scatizzi
- General Surgery Unit, Santa Maria Annunziata & Serristori Hospital, Firenze, Italy
| |
Collapse
|
13
|
El-Dahiyat F, Abu Hammour K, Abu Farha R, Manaseer Q, Al Momanee A, Allan A, Alkhawaldeh R. Jordanians' knowledge, attitude and practice regarding adverse drug reactions reporting. Saudi Pharm J 2023; 31:1197-1201. [PMID: 37273263 PMCID: PMC10236368 DOI: 10.1016/j.jsps.2023.05.016] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/05/2023] [Accepted: 05/13/2023] [Indexed: 06/06/2023] Open
Abstract
Objectives The purpose of the current study was to evaluate the general public knowledge, attitudes, and practice regarding Adverse Drug Reactions (ADRs) reporting and pharmacovigilance in Jordan. Methods A cross-sectional study was conducted between July 16, 2022, and July 30, 2022, in Jordan. During the study period, an electronic survey consisting of 4 sections was administered to a convenience sample of Jordanians (aged 18 or above) using 2 social media platforms (Facebook and WhatsApp). Logistic regression analysis was used to screen the predictors of ADRs reporting by the participants. Results A total of 441 participants completed the survey. The majority of the participants (67.6%) were females, 53.1% between 26 and 45 years old. Almost all participants (96.3%) were always aware of the indication of the medications they take, the time and frequency (87.8%), and the duration of medications (84.4%). Nearly one-third of the participants (37.4%) asked about their medications' ADRs. However, the drug information leaflet was the most frequently used source of ADR information (33.3%). The majority of responders believed that both healthcare providers and consumers should report ADRs (93.4% and 80.3%, respectively). Only one-quarter of respondents (27.2%) believed that consumers could directly report ADRs through the Jordan pharmacovigilance program. The majority of patients who had experienced ADRs (70.3%) were aware that ADRs should be reported, and among them, 91.9% had reported the ADRs to healthcare providers. Furthermore, few participants (8.1%) reported it to the Jordan National Pharmacovigilance Centre (JNCP). Linear regression revealed that none of the demographic characteristics (age, gender, education, job, and social status) were affecting public reporting practice of the ADRs (P > 0.05 for all). Conclusion Respondents showed fair knowledge about adverse drug reactions and their reporting. However, there is a need to initiate educational activities and intervention programs to raise awareness about the JNPC, which will have a positive impact on public health and ensure safe medication use in Jordan.
Collapse
Affiliation(s)
- Faris El-Dahiyat
- Clinical Pharmacy Program, College of Pharmacy, Al Ain University, Al Ain, United Arab Emirates
- AAU Health and Biomedical Research Center, Al Ain University, Abu Dhabi, United Arab Emirates
| | - Khawla Abu Hammour
- Department of Biopharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, the University of Jordan, Amman, Jordan
| | - Rana Abu Farha
- Department of Clinical Pharmacy and Therapeutics, Faculty of Pharmacy, Applied Science Private University, Amman, Jordan
| | - Qusai Manaseer
- Orthopedic Department, Jordan University Teaching hospital, Amman, Jordan
| | - Ala'a Al Momanee
- Pharmacy Department, Jordan University Teaching Hospital, Amman, Jordan
| | - Aya Allan
- Pharmacy Department, Jordan University Teaching Hospital, Amman, Jordan
| | - Rama Alkhawaldeh
- Department of Clinical Pharmacy and Therapeutics, Faculty of Pharmacy, Applied Science Private University, Amman, Jordan
| |
Collapse
|
14
|
Shang Z, Wanyan P, Zhang B, Wang M, Wang X. A systematic review, umbrella review, and quality assessment on clinical translation of stem cell therapy for knee osteoarthritis: Are we there yet? Stem Cell Res Ther 2023; 14:91. [PMID: 37061744 PMCID: PMC10105961 DOI: 10.1186/s13287-023-03332-5] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2022] [Accepted: 04/06/2023] [Indexed: 04/17/2023] Open
Abstract
BACKGROUND The success of stem cell therapy for knee osteoarthritis (KOA) in preclinical animal models has accelerated the pace of clinical translation. However, it remains uncertain whether the current scientific evidence supports the clinical application of stem cells in treating KOA. A comprehensive evaluation of the safety and efficacy of stem cell therapies and scientific evidence quality is necessary. METHODS Using "stem cells" and "knee osteoarthritis" as the search terms, several databases, including PubMed, Web of Science, Cochrane, Embase, and Clinicaltrials.gov, were searched on August 25, 2022, and updated on February 27, 2023. Clinical studies that reported adverse reactions (ARs) of stem cell therapy in KOA patients were included without limiting the type of studies. Quantitative systematic reviews of stem cell therapy for KOA that conducted meta-analysis were included. Two researchers conducted literature screening and data extraction independently, and the evidence quality was evaluated according to the Institute of Health Economics and AMSTAR 2 criteria. RESULTS Fifty clinical studies and 13 systematic reviews/meta-analyses (SRs/MAs) were included. Nineteen ARs were reported in 50 studies, including five knee-related ARs, seven common ARs, and seven other ARs. Some studies reported over 10% prevalence of knee pain (24.5%; 95% CI [14.7%, 35.7%]), knee effusion (12.5%; 95% CI [4.8%, 22.5%]), and knee swelling (11.9%; 95% CI [3.5%, 23.5%]). Additionally, two studies have reported cases of prostate cancer and breast tumors, respectively. However, these two studies suggest that stem cell therapy does not bring significant ARs to patients. SRs/MAs results revealed that stem cell therapy relieved pain in patients over time but did not improve knee function. However, current clinical studies have limited evidence regarding study objectives, test designs, and patient populations. Similarly, SRs/MAs have inadequate evidence regarding study design, risk of bias assessment, outcome description, comprehensive discussion, and potential conflicts of interest. CONCLUSIONS The inefficacy of stem cells, the risk of potential complications, and the limited quality of evidence from current studies precluded any recommendation for using stem cell products in patients with KOA. Clinical translation of stem cell therapies remains baseless and should be cautiously approached until more robust evidence is available. PROSPERO registration number: CRD42022355875.
Collapse
Affiliation(s)
- Zhizhong Shang
- The First Clinical Medical College of Lanzhou University, Lanzhou, 730000, China
| | - Pingping Wanyan
- Gansu University of Chinese Medicine, Lanzhou, 730000, China
- The Second Hospital of Lanzhou University, Lanzhou, 730000, China
| | - Baolin Zhang
- The First Clinical Medical College of Lanzhou University, Lanzhou, 730000, China
| | - Mingchuan Wang
- The First Clinical Medical College of Lanzhou University, Lanzhou, 730000, China
| | - Xin Wang
- The First Clinical Medical College of Lanzhou University, Lanzhou, 730000, China.
- Chengren Institute of Traditional Chinese Medicine, Lanzhou, 730000, Gansu Province, China.
- Department of Spine, Changzheng Hospital, Naval Medical University, Shanghai, 200003, China.
| |
Collapse
|
15
|
Catarci M, Guadagni S, Masedu F, Montemurro LA, Ciano P, Benedetti M, Delrio P, Garulli G, Pirozzi F, Scatizzi M. Blood Transfusions and Adverse Events after Colorectal Surgery: A Propensity-Score-Matched Analysis of a Hen-Egg Issue. Diagnostics (Basel) 2023; 13:diagnostics13050952. [PMID: 36900095 PMCID: PMC10000587 DOI: 10.3390/diagnostics13050952] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/10/2023] [Revised: 02/27/2023] [Accepted: 03/01/2023] [Indexed: 03/06/2023] Open
Abstract
Blood transfusions are considered a risk factor for adverse outcomes after colorectal surgery. However, it is still unclear if they are the cause (the hen) or the consequence (the egg) of adverse events. A prospective database of 4529 colorectal resections gathered over a 12-month period in 76 Italian surgical units (the iCral3 study), reporting patient-, disease-, and procedure-related variables, together with 60-day adverse events, was retrospectively analyzed identifying a subgroup of 304 cases (6.7%) that received intra- and/or postoperative blood transfusions (IPBTs). The endpoints considered were overall and major morbidity (OM and MM, respectively), anastomotic leakage (AL), and mortality (M) rates. After the exclusion of 336 patients who underwent neo-adjuvant treatments, 4193 (92.6%) cases were analyzed through a 1:1 propensity score matching model including 22 covariates. Two well-balanced groups of 275 patients each were obtained: group A, presence of IPBT, and group B, absence of IPBT. Group A vs. group B showed a significantly higher risk of overall morbidity (154 (56%) vs. 84 (31%) events; OR 3.07; 95%CI 2.13-4.43; p = 0.001), major morbidity (59 (21%) vs. 13 (4.7%) events; OR 6.06; 95%CI 3.17-11.6; p = 0.001), and anastomotic leakage (31 (11.3%) vs. 8 (2.9%) events; OR 4.72; 95%CI 2.09-10.66; p = 0.0002). No significant difference was recorded between the two groups concerning the risk of mortality. The original subpopulation of 304 patients that received IPBT was further analyzed considering three variables: appropriateness of BT according to liberal transfusion thresholds, BT following any hemorrhagic and/or major adverse event, and major adverse event following BT without any previous hemorrhagic adverse event. Inappropriate BT was administered in more than a quarter of cases, without any significant influence on any endpoint. The majority of BT was administered after a hemorrhagic or a major adverse event, with significantly higher rates of MM and AL. Finally, a major adverse event followed BT in a minority (4.3%) of cases, with significantly higher MM, AL, and M rates. In conclusion, although the majority of IPBT was administered with the consequence of hemorrhage and/or major adverse events (the egg), after adjustment accounting for 22 covariates, IPBT still resulted in a definite source of a higher risk of major morbidity and anastomotic leakage rates after colorectal surgery (the hen), calling urgent attention to the implementation of patient blood management programs.
Collapse
Affiliation(s)
- Marco Catarci
- General Surgery Unit, Sandro Pertini Hospital, ASL Roma 2, 00157 Rome, Italy
- Correspondence:
| | - Stefano Guadagni
- General Surgery Unit, University of L’Aquila, 67100 L’Aquila, Italy
| | - Francesco Masedu
- Department of Applied Clinical Sciences and Biotechnology, University of L’Aquila, 67100 L’Aquila, Italy
| | | | - Paolo Ciano
- General Surgery Unit, Sandro Pertini Hospital, ASL Roma 2, 00157 Rome, Italy
| | - Michele Benedetti
- General Surgery Unit, Sandro Pertini Hospital, ASL Roma 2, 00157 Rome, Italy
| | - Paolo Delrio
- Colorectal Surgical Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori, “Fondazione Giovanni Pascale IRCCS-Italia”, 80131 Napoli, Italy
| | | | - Felice Pirozzi
- General Surgery Unit, ASL Napoli 2 Nord, 80078 Pozzuoli (NA), Italy
| | - Marco Scatizzi
- General Surgery Unit, Santa Maria Annunziata & Serristori Hospital, 50012 Firenze, Italy
| |
Collapse
|
16
|
Shintani AO, Rabelo-da-Ponte FD, Marchionatti LE, Watts D, Ferreira de Souza F, Machado CDS, Pulice RF, Signori GM, Luzini RR, Kauer-Sant'Anna M, Passos IC. Prenatal and perinatal risk factors for bipolar disorder: A systematic review and meta-analysis. Neurosci Biobehav Rev 2023; 144:104960. [PMID: 36375585 DOI: 10.1016/j.neubiorev.2022.104960] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2022] [Revised: 11/08/2022] [Accepted: 11/09/2022] [Indexed: 11/13/2022]
Abstract
BACKGROUND Perinatal and prenatal risk factors may be implicated in the development of bipolar disorder, but literature lacks a comprehensive account of possible associations. METHODS We performed a systematic review and meta-analyses of observational studies detailing the association between prenatal and perinatal risk factors and bipolar disorder in adulthood by searching PubMed, Embase, Web of Science and Psycinfo for articles published in any language between January 1st, 1960 and September 20th, 2021. Meta-analyses were performed when risk factors were available in at least two studies. FINDINGS Twenty seven studies were included with 18 prenatal or perinatal factors reported across the literature. Peripartum asphyxia (k = 5, OR = 1.46 [1.02; 2.11]), maternal stress during pregnancy (k = 2, OR = 12.00 [3.30; 43.59]), obstetric complications (k = 6, OR = 1.41 [1.18; 1.69]), and birth weight less than 2500 g (k = 5, OR = 1.28 [1.04; 1.56]) were associated with an increased risk for bipolar disorder. INTERPRETATION Perinatal and prenatal risk factors are implicated in the pathogenesis of bipolar disorder, supporting a role of prenatal care in preventing the condition.
Collapse
Affiliation(s)
- Augusto Ossamu Shintani
- Laboratory of Molecular Psychiatry, Centro de Pesquisa Experimental (CPE) and Centro de Pesquisa Clínica (CPC), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil; Universidade Federal do Rio Grande do Sul, School of Medicine, Graduate Program in Psychiatry and Behavioral Sciences, Department of Psychiatry, Porto Alegre, RS, Brazil.
| | - Francisco Diego Rabelo-da-Ponte
- Laboratory of Molecular Psychiatry, Centro de Pesquisa Experimental (CPE) and Centro de Pesquisa Clínica (CPC), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil; Universidade Federal do Rio Grande do Sul, School of Medicine, Graduate Program in Psychiatry and Behavioral Sciences, Department of Psychiatry, Porto Alegre, RS, Brazil; University of Central Lancashire, School of Pharmacy and Biomedical Sciences, Preston, United Kingdom.
| | - Lauro Estivalete Marchionatti
- Laboratory of Molecular Psychiatry, Centro de Pesquisa Experimental (CPE) and Centro de Pesquisa Clínica (CPC), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.
| | - Devon Watts
- Neuroscience Graduate Program, McMaster University, 1280 Main Street West, Hamilton, ON, Canada.
| | - Fernando Ferreira de Souza
- Laboratory of Molecular Psychiatry, Centro de Pesquisa Experimental (CPE) and Centro de Pesquisa Clínica (CPC), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil; Universidade Federal do Rio Grande do Sul, School of Medicine, Graduate Program in Psychiatry and Behavioral Sciences, Department of Psychiatry, Porto Alegre, RS, Brazil.
| | - Cristiane Dos Santos Machado
- Laboratory of Molecular Psychiatry, Centro de Pesquisa Experimental (CPE) and Centro de Pesquisa Clínica (CPC), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil; Universidade Federal do Rio Grande do Sul, School of Medicine, Graduate Program in Psychiatry and Behavioral Sciences, Department of Psychiatry, Porto Alegre, RS, Brazil.
| | - Rafaela Fernandes Pulice
- Laboratory of Molecular Psychiatry, Centro de Pesquisa Experimental (CPE) and Centro de Pesquisa Clínica (CPC), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.
| | - Giovanna Maiolli Signori
- Laboratory of Molecular Psychiatry, Centro de Pesquisa Experimental (CPE) and Centro de Pesquisa Clínica (CPC), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.
| | - Rafael Rocha Luzini
- Laboratory of Molecular Psychiatry, Centro de Pesquisa Experimental (CPE) and Centro de Pesquisa Clínica (CPC), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.
| | - Márcia Kauer-Sant'Anna
- Laboratory of Molecular Psychiatry, Centro de Pesquisa Experimental (CPE) and Centro de Pesquisa Clínica (CPC), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil; Universidade Federal do Rio Grande do Sul, School of Medicine, Graduate Program in Psychiatry and Behavioral Sciences, Department of Psychiatry, Porto Alegre, RS, Brazil; Instituto Nacional de Ciência e Tecnologia Translacional em Medicina (INCT-TM), Porto Alegre, RS, Brazil.
| | - Ives Cavalcante Passos
- Laboratory of Molecular Psychiatry, Centro de Pesquisa Experimental (CPE) and Centro de Pesquisa Clínica (CPC), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil; Universidade Federal do Rio Grande do Sul, School of Medicine, Graduate Program in Psychiatry and Behavioral Sciences, Department of Psychiatry, Porto Alegre, RS, Brazil; Instituto Nacional de Ciência e Tecnologia Translacional em Medicina (INCT-TM), Porto Alegre, RS, Brazil.
| |
Collapse
|
17
|
Zhai H, Wei H, Xia J, Wang W. Dose-response relationship of resistance training for muscle morphology and strength in elderly cancer patients: A meta-analysis. Front Med (Lausanne) 2023; 10:1049248. [PMID: 37089606 PMCID: PMC10115997 DOI: 10.3389/fmed.2023.1049248] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2022] [Accepted: 01/17/2023] [Indexed: 04/25/2023] Open
Abstract
Objective To systematically evaluate the effects of resistance training (RT) on muscle strength and muscle hypertrophy in elderly cancer patients, and to provide dose-response relationships of RT variables that could improve muscle strength and morphology in elderly cancer patients. Method The Review Manager 5.3 was applied to analyze the 12 literatures (616 participants) through random or fixed effects model and global effect size to examine upper limb strength, lower extremity strength, and muscle hypertrophy. Sub-group analysis was made on five variables: the total number of repeated training times/week, load intensity, exercise frequency/week, exercise duration and gender. This study also examines the heterogeneity and publication bias. Results Twelve literatures (616 participants, 60-80 years) were included in meta-analysis. RT significantly increased the upper limb muscular strength (SMD = 0.51, 95% CI: 0.10-0.93; Z = 2.41; p = 0.02) and lower extremity strength (SMD = 0.48, 95% CI: 0.28-0.67; Z = 4.82; p < 0.00001), but had no significant effect on muscle morphology(SMD = 0.21, 95% CI: 0.01-0.42; Z = 1.88; p = 0.06). In subgroup analysis for lower extremity muscle strength in elderly male cancer patients, it was found that male intensity of 70-90%1RM, volume of 400-500 times per week, frequencies of 3 times per week, and session of 12-24 weeks, revealed the greatest effect. Funnel plot of the three studies shows that the results were reliable, and no publication bias was found. Conclusion RT had medium effects on improving muscle strength in elderly cancer patients, but it is not effective in improving muscle hypertrophy. In addition, when RT is performed, different training protocols can have an effect on the growth of muscle strength. Therefore, a lower extremity training protocol with a training intensity of 70-90% 1RM, a total of 400-500 repetitions per week, 3 times per week, and an exercise session of 12-24 weeks is most effective in improving lower extremity strength in elderly male cancer patients.
Collapse
Affiliation(s)
- Haiting Zhai
- School of Basic Sciences for Aviation, Naval Aviation University, Yantai, China
- School of Strength and Conditioning Training, Beijing Sport University, Beijing, China
| | - Hongwen Wei
- School of Strength and Conditioning Training, Beijing Sport University, Beijing, China
- *Correspondence: Hongwen Wei,
| | - Jixiang Xia
- School of Basic Sciences for Aviation, Naval Aviation University, Yantai, China
- Jixiang Xia,
| | - Wei Wang
- School of Basic Sciences for Aviation, Naval Aviation University, Yantai, China
| |
Collapse
|
18
|
Betz VM, Holzgruber M, Simon J, Uhlemann F, Niemeyer P, Müller PE, Niethammer TR. The Effect of Smoking on the Outcome of Matrix-Based Autologous Chondrocyte Implantation: Data from the German Cartilage Registry. J Knee Surg 2023; 36:181-187. [PMID: 34237778 DOI: 10.1055/s-0041-1731456] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
Smoking is known to have various deleterious effects on health. However, it is not clear whether smoking negatively affects the postoperative outcome following matrix-based autologous cartilage implantation (MACI) in the knee. The purpose of this study was to evaluate the effect of smoking on the outcome of MACI in the knee. A total of 281 patients receiving MACI in the knee between 2015 and 2018 were registered in the German Cartilage Database. The cohort was divided into ex-smokers, smokers, and nonsmokers. Data regarding the Knee Injury and Osteoarthritis Outcome Score (KOOS), the numeric rating scale (NRS) for pain, and satisfaction with the outcome were analyzed and compared. Follow-ups were performed at 6, 12, and 24 months after surgery. Of the 281 patients, 225 (80.1%) were nonsmokers, 43 (15.3%) were smokers, and 13 (4.6%) were ex-smokers. The three groups were comparable with respect to age, sex, body mass index (BMI), height, defect size, the need for additional reconstruction of the subchondral bone defect, number of previous knee surgeries, and defect location. However, nonsmokers had a significantly lower weight as compared with smokers. Besides a significantly lower preoperative NRS of nonsmokers as compared with smokers, there were no significant differences between the three groups with respect to KOOS, NRS, and satisfaction at 6, 12, and 24 months of follow-ups. The present study of data retrieved from the German Cartilage Registry suggests that the smoking status does not influence the outcome of MACI in the knee.
Collapse
Affiliation(s)
- Volker M Betz
- Department of Orthopaedics, Physical Medicine and Rehabilitation, University Hospital, Ludwig-Maximilians-University Munich, Munich, Germany
| | - Martin Holzgruber
- Department of Orthopaedics, Physical Medicine and Rehabilitation, University Hospital, Ludwig-Maximilians-University Munich, Munich, Germany
| | - Johanna Simon
- Department of Orthopaedics, Physical Medicine and Rehabilitation, University Hospital, Ludwig-Maximilians-University Munich, Munich, Germany
| | - Felix Uhlemann
- Department of Orthopaedics, Physical Medicine and Rehabilitation, University Hospital, Ludwig-Maximilians-University Munich, Munich, Germany
| | - Philipp Niemeyer
- Department of Orthopaedic Surgery and Traumatology, Freiburg University Hospital, Freiburg, Germany.,Department of Orthopaedic Surgery, Orthopädische Chirurgie München Clinic, Munich, Germany
| | - Peter E Müller
- Department of Orthopaedics, Physical Medicine and Rehabilitation, University Hospital, Ludwig-Maximilians-University Munich, Munich, Germany
| | - Thomas R Niethammer
- Department of Orthopaedics, Physical Medicine and Rehabilitation, University Hospital, Ludwig-Maximilians-University Munich, Munich, Germany
| |
Collapse
|
19
|
Guelman R, Sánchez A, Varsavsky M, Brun LR, García ML, Sarli M, Paula R, Farias V, Zanchetta MB, Giacoia E, Salerni H, Maffei L, Premrou V, Oliveri B, Brance ML, Pavlove M, Karlsbrum S, Larroudé MS, Costanzo PR. Effect of Teriparatide on Bone Mineral Density and Bone Markers in Real-Life: Argentine Experience. Int J Endocrinol 2023; 2023:9355672. [PMID: 36686321 PMCID: PMC9859697 DOI: 10.1155/2023/9355672] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/20/2021] [Revised: 10/23/2022] [Accepted: 12/12/2022] [Indexed: 01/15/2023] Open
Abstract
PURPOSE To evaluate the effect of teriparatide (TPTD) on bone mineral density (BMD) and bone markers under clinical practice conditions. To assess whether the results in real-life match those published in clinical trials. METHODS Cross-sectional study of postmenopausal women treated with TPTD for at least 12 months. RESULTS 264 patients were included in the study. Main characteristics are as follows: age: 68.7 ± 10.2 years, previous fractures: 57.6%, and previously treated with antiresorptive (AR-prior): 79%. All bone turnover markers studied significantly increased after 6 months. CTX and BGP remained high up to 24 months, but total and bone alkaline phosphatase returned to basal values at month 18. There was a significant increase in lumbar spine (LS) BMD after 6 months (+6.2%), with a maximum peak at 24 months (+13%). Femoral neck (FN) and total hip (TH) BMD showed a significant increase later than LS (just at month 12), reaching a maximum peak at month 24 (FN + 7.9% and TH + 5.5%). A significant increase in LS BMD was found from month 6 to month 24 compared to basal in both AR-naïve, and AR-prior patients (+16.7% and +10.5%, respectively), without significant differences between the two groups. Comparable results were found in FN and TH BMD. Main conclusions. As reported in real-life clinical studies, treatment of osteoporotic postmenopausal women with TPTD induced a significant increase in bone turnover markers from month 6 onward and an increase in BMD from months 6-12 with continuous gain up to month 24. The real-life results of our study matched the results of randomized clinical trials. In addition, TPTD induced an increase in BMD, regardless of the previous use of AR.
Collapse
Affiliation(s)
- Rodolfo Guelman
- Servicio de Endocrinología y Medicina Nuclear, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
| | | | - Mariela Varsavsky
- Servicio de Endocrinología y Medicina Nuclear, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
| | - Lucas R. Brun
- CONICET, Rosario, Argentina
- Laboratorio de Biología Ósea, Fac Cs Médicas, Universidad Nacional de Rosario, Rosario, Argentina
| | | | - Marcelo Sarli
- Instituto de Investigaciones Metabólicas, Universidad del Salvador, Buenos Aires, Argentina
| | - Rey Paula
- Instituto de Investigaciones Metabólicas, Universidad del Salvador, Buenos Aires, Argentina
| | - Vanina Farias
- Instituto de Investigaciones Metabólicas, Universidad del Salvador, Buenos Aires, Argentina
| | - María Belén Zanchetta
- Instituto de Investigaciones Metabólicas, Universidad del Salvador, Buenos Aires, Argentina
| | - Evangelina Giacoia
- Servicio de Endocrinología y Metabolismo, Hospital Posadas, Buenos Aires, Argentina
| | - Helena Salerni
- Consultorios de Investigación Clínica Endocrinológica y del Metabolismo Óseo (CICEMO), Buenos Aires, Argentina
| | - Laura Maffei
- Consultorios Asociados de Endocrinología Dra. Laura Maffei, Buenos Aires, Argentina
| | - Valeria Premrou
- Consultorios Asociados de Endocrinología Dra. Laura Maffei, Buenos Aires, Argentina
| | | | - María Lorena Brance
- CONICET, Rosario, Argentina
- Reumatología y Enfermedades Óseas, Rosario, Argentina
| | | | | | | | - Pablo René Costanzo
- Servicio de Endocrinología y Medicina Nuclear, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
| |
Collapse
|
20
|
Chen C, Li X, Su Y, You Z, Wan R, Hong K. Adherence with cardiovascular medications and the outcomes in patients with coronary arterial disease: "Real-world" evidence. Clin Cardiol 2022; 45:1220-1228. [PMID: 36116032 DOI: 10.1002/clc.23898] [Citation(s) in RCA: 15] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/14/2022] [Revised: 07/20/2022] [Accepted: 07/26/2022] [Indexed: 12/15/2022] Open
Abstract
BACKGROUND Cardiovascular medications are vital for the secondary prevention of coronary arterial disease (CAD). However, the effect of cardiovascular medication may depend on the optimal adherence of the patients. This meta-analysis aims to determine the magnitude of adherence to vascular medications that influences the absolute and relative risks (RRs) of mortality in patients with CAD in real-world settings. METHODS The Cochrane Library, PubMed, and EMBASE databases were searched through March 1, 2022. Prospective studies reporting association as RR and 95% confidence interval between cardiovascular medication adherence and any cardiovascular events and/or all-cause mortality in patients with CAD were included. A one-stage robust error meta-regression method was used to summarize the dose-specific relationships. RESULTS A total of 18 studies were included. There is a significant inverse linear association between cardiovascular medication adherence and cardiovascular events (pnonlinearity = .68) or mortality (pnonlinearity = .82). The exposure-effect analysis showed that an improvement of 20% cardiovascular medication adherence was associated with 8% or 12% lower risk of any cardiovascular events or mortality, respectively. In subgroup analysis, the benefit was observed in adherence of stain (RR: 0.90, for cardiovascular events, RR: 0.85, for mortality), angiotensin-converting enzyme inhibitors (ACEI)/angiotensin II receptor blockers (ARB)(RR: 0.90, for mortality), and antiplatelet agent (RR: 0.89 for mortality) but not in beta-blocker (RR: 0.90, p = .14, for cardiovascular events, RR: 0.97, p = .32 for mortality). Estimated absolute differences per 1 million individuals per year for mortality associated with 20% improvement were 175 cases for statin, 129 cases for antiplatelet, and 117 cases for ACEI/ARB. CONCLUSION Evidence from the real word showed poor adherence to vascular medications contributes to a considerable proportion of all cardiovascular disease events and mortality in patients with CAD.
Collapse
Affiliation(s)
- Chen Chen
- Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
| | - Xiaoqing Li
- Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
| | - Yuhao Su
- Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
| | - Zhigang You
- Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
| | - Rong Wan
- Jiangxi Key Laboratory of Molecular Medicine, Nanchang, Jiangxi, China
| | - Kui Hong
- Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.,Jiangxi Key Laboratory of Molecular Medicine, Nanchang, Jiangxi, China.,Department of Genetic Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
| |
Collapse
|
21
|
Xue CY, Zhou MQ, Zheng QY, Zhang JH, Cheng WT, Bai XH, Zhou F, Wu AM, Nie B, Liu WJ, Lou LX. Thiazolidinediones play a positive role in the vascular endothelium and inhibit plaque progression in diabetic patients with coronary atherosclerosis: A systematic review and meta-analysis. Front Cardiovasc Med 2022; 9:1043406. [PMID: 36523368 PMCID: PMC9744793 DOI: 10.3389/fcvm.2022.1043406] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2022] [Accepted: 11/07/2022] [Indexed: 03/26/2024] Open
Abstract
UNLABELLED Rosiglitazone (Avandia) and pioglitazone (Actos) belong to the class of thiazolidinediones (TZDs) drugs that act by increasing insulin sensitivity and are widely used for treating diabetic patients with insulin resistance. TZDs exhibit anti-inflammatory and antioxidant properties, then may play an active role in inhibiting plaque formation and coronary atherosclerosis. But the results of evidence-based medicine suggest that TZDs may increase the risk of cardiovascular adverse events. To explore the dispute in depth, our meta-analysis aimed to evaluate the changes in vascular endothelial and plaque-related indicators following treatment with TZDs in diabetic patients with coronary atherosclerosis. According to our meta-analysis, TZDs showed an inhibiting effect on plaque progression and a protective effect on the vascular endothelium in patients with diabetes and coronary atherosclerosis. Interestingly, these effects may not depend on the regulation of inflammation and lipid metabolism. By this token, TZDs may develop a potential protective effect on myocardial infarction. SYSTEMATIC REVIEW REGISTRATION [https://www.crd.york.ac.uk/prospero/], identifier [CRD42021231663].
Collapse
Affiliation(s)
- Cheng Yuan Xue
- Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
- Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing, China
| | - Meng Qi Zhou
- Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
- Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing, China
| | - Qi Yan Zheng
- Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China
| | - Jin Hui Zhang
- Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
| | - Wei Ting Cheng
- Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
- Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing, China
| | - Xue Hui Bai
- Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
- Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing, China
| | - Fen Zhou
- Nursing School, Beijing University of Chinese Medicine, Beijing, China
| | - Ai Ming Wu
- Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
- Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing, China
| | - Bo Nie
- Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
- Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing, China
| | - Wei Jing Liu
- Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
- Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing, China
| | - Li Xia Lou
- Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
- Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing, China
| |
Collapse
|
22
|
Brain Oxygen-Directed Management of Aneurysmal Subarachnoid Hemorrhage. Temporal Patterns of Cerebral Ischemia During Acute Brain Attack, Early Brain Injury, and Territorial Sonographic Vasospasm. World Neurosurg 2022; 166:e215-e236. [PMID: 35803565 DOI: 10.1016/j.wneu.2022.06.149] [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: 03/03/2022] [Revised: 06/28/2022] [Accepted: 06/29/2022] [Indexed: 12/15/2022]
Abstract
BACKGROUND Neurocritical management of aneurysmal subarachnoid hemorrhage focuses on delayed cerebral ischemia (DCI) after aneurysm repair. METHODS This study conceptualizes the pathophysiology of cerebral ischemia and its management using a brain oxygen-directed protocol (intracranial pressure [ICP] control, eubaric hyperoxia, hemodynamic therapy, arterial vasodilation, and neuroprotection) in patients with subarachnoid hemorrhage, undergoing aneurysm clipping (n = 40). RESULTS The brain oxygen-directed protocol reduced Lbo2 (Pbto2 [partial pressure of brain tissue oxygen] <20 mm Hg) from 67% to 15% during acute brain attack (<24 hours of ictus), by increasing Pbto2 from 11.31 ± 9.34 to 27.85 ± 6.76 (P < 0.0001) and then to 29.09 ± 17.88 within 72 hours. Day-after-bleed, Fio2 change, ICP, hemoglobin, and oxygen saturation were predictors for Pbto2 during early brain injury. Transcranial Doppler ultrasonography velocities (>20 cm/second) increased at day 2. During DCI caused by territorial sonographic vasospasm (TSV), middle cerebral artery mean velocity (Vm) increased from 45.00 ± 15.12 to 80.37 ± 38.33/second by day 4 with concomitant Pbto2 reduction from 29.09 ± 17.88 to 22.66 ± 8.19. Peak TSV (days 7-12) coincided with decline in Pbto2. Nicardipine mitigated Lbo2 during peak TSV, in contrast to nimodipine, with survival benefit (P < 0.01). Intravenous and cisternal nicardipine combination had survival benefit (Cramer Φ = 0.43 and 0.327; G2 = 28.32; P < 0.001). This study identifies 4 zones of Lbo2 during survival benefit (Cramer Φ = 0.43 and 0.3) TSV, uncompensated; global cerebral ischemia, compensated, and normal Pbto2. Admission Glasgow Coma Scale score (not increased ICP) was predictive of low Pbto2 (β = 0.812, R2 = 0.661, F1,30 = 58.41; P < 0.0001) during early brain injury. Coma was the only credible predictor for mortality (odds ratio, 7.33/>4.8∗; χ2 = 7.556; confidence interval, 1.70-31.54; P < 0.01) followed by basilar aneurysm, poor grade, high ICP and Lbo2 during TSV. Global cerebral ischemia occurs immediately after the ictus, persisting in 30% of patients despite the high therapeutic intensity level, superimposed by DCI during TSV. CONCLUSIONS We propose implications for clinical practice and patient management to minimize cerebral ischemia.
Collapse
|
23
|
Chen P, Teo DWH, Foo DXY, Derry HA, Hayward BT, Schulz KW, Hayward C, McKay TA, Ong DC. Real-world effectiveness of a social-psychological intervention translated from controlled trials to classrooms. NPJ SCIENCE OF LEARNING 2022; 7:20. [PMID: 36038565 PMCID: PMC9424297 DOI: 10.1038/s41539-022-00135-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 08/31/2021] [Accepted: 05/30/2022] [Indexed: 06/15/2023]
Abstract
Social-psychological interventions have raised the learning and performance of students in rigorous efficacy trials. Yet, after they are distributed "in the wild" for students to self-administer, there has been little research following up on their translational effectiveness. We used cutting-edge educational technology to tailor, scale up, and track a previously-validated Strategic Resource Use intervention among 12,065 college students in 14 STEM and Economics classes. Students who self-administered this "Exam Playbook" benefitted by an average of 2.17 percentage points (i.e., a standardized effect size of 0.18), compared to non-users. This effect size was 1.65 percentage points when controlling for college entrance exam scores and 1.75 [-1.88] for adding [dropping] the Exam Playbook in stratified matching analyses. Average benefits differed in magnitude by the conduciveness of the class climate (including peer norms and incentives), gender, first-generation status, as well as how often and how early they used the intervention. These findings on how, when, and who naturally adopts these resources address a need to improve prediction, translation, and scalability of social-psychological intervention benefits.
Collapse
Affiliation(s)
- Patricia Chen
- Department of Psychology, National University of Singapore, Singapore, Singapore.
- Institute for Applied Learning Sciences and Educational Technology, National University of, Singapore, Singapore.
| | - Dennis W H Teo
- Department of Information Systems and Analytics, National University of Singapore, Singapore, Singapore
| | - Daniel X Y Foo
- Department of Psychology, National University of Singapore, Singapore, Singapore
| | - Holly A Derry
- The Center for Academic Innovation, University of Michigan, Ann Arbor, MI, USA
| | - Benjamin T Hayward
- The Center for Academic Innovation, University of Michigan, Ann Arbor, MI, USA
| | - Kyle W Schulz
- The Center for Academic Innovation, University of Michigan, Ann Arbor, MI, USA
| | - Caitlin Hayward
- The Center for Academic Innovation, University of Michigan, Ann Arbor, MI, USA
| | - Timothy A McKay
- Departments of Physics and Astronomy, College of Literature, Science, and the Arts, and School of Education, University of Michigan, Ann Arbor, MI, USA
| | - Desmond C Ong
- Department of Psychology, University of Texas at Austin, Texas, USA.
| |
Collapse
|
24
|
Ulmeanu R, Bloju S, Vittos O. Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study). J Asthma Allergy 2022; 15:919-933. [PMID: 35836969 PMCID: PMC9275489 DOI: 10.2147/jaa.s358798] [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: 01/17/2022] [Accepted: 05/27/2022] [Indexed: 12/01/2022] Open
Abstract
Introduction Asthma treatment guidelines advocate the use of long-acting beta2-agonists (LABA) in addition to inhaled corticosteroids (ICS) in patients whose asthma is uncontrolled by ICS alone. This is the first study done in Romania, which collected the real-world data on the effects of Foster® (extrafine beclomethasone dipropionate/formoterol fumarate BDP/FF in a pressurized metered-dose inhaler pMDI 100/6 μg formulation) in adult asthmatic population. Objective We aimed to assess the asthma symptoms control, pulmonary function and quality of life parameters in a heterogeneous Romanian asthmatic adult outpatient population, treated with extrafine BDP/FF 100/6 μg pMDI. Methods This was a prospective, multicenter, observational study involving 30 pulmonologists randomly selected from the Romanian healthcare system, which did not declare any competing interests. Recruitment period was Oct 2018 - Feb 2019, while the patients' observational period was 24 weeks. The study included poorly controlled and uncontrolled adult asthma outpatients treated with non-extrafine formulations medication, for which the treatment indication, according to Global Initiative for Asthma (GINA) 2018, was the use of an ICS-LABA combination. The study collected demographic data, smoking habits, comorbidities, data regarding asthma diagnosis, the evolution of asthma symptoms, spirometry, Asthma Control Questionnaire (ACQ-7) scoring test, current and concomitant treatment. Results Of 302 included patients, 290 completed the study. Pulmonary function parameters assessed during the trial (forced expiratory volume in one second - FEV1 and forced vital capacity - FVC) showed a significant improvement versus baseline (p<0.001). ACQ-7 score decreased significantly from 3.09±0.83 (visit 1) to 1.56±0.89 (visit 2) and to 1.09±0.81 (visit 3) (p<0.001). At the end of the study, 127 (43.79%) patients were well controlled (ACQ-7 score < 0.75). Conclusion This observational study demonstrates the effectiveness and safety of extrafine fixed combination of BDP/FF (100/6 μg) pMDI in Romanian adult asthma patients uncontrolled with non-extrafine medication in a real-world setting, leading to clinically and statistically improvements in asthma control and pulmonary function.
Collapse
Affiliation(s)
- Ruxandra Ulmeanu
- Postgraduate Training School of the Romanian Society of Pulmonology; Bronchoscopy Department - Institute of Pulmonology "Marius Nasta", Bucharest, Romania
| | | | - Oana Vittos
- Clinical Research Department, Medone Research, Bucharest, Romania
| |
Collapse
|
25
|
Monti M, Sullo FG, Iamurri AP, Gianni C, Silimbani P, Bartolini G, Valgiusti M, Esposito L, Montanari D, Antonini S, Frassineti GL. Recurrent pneumothorax in a patient with liposarcoma as either a complication of lung micrometastasis or a potential adverse event from antibiotic therapy: A case report. Oncol Lett 2022; 24:202. [PMID: 35720484 PMCID: PMC9178694 DOI: 10.3892/ol.2022.13324] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2022] [Accepted: 03/31/2022] [Indexed: 11/30/2022] Open
Abstract
Spontaneous pneumothorax (PNX) is an infrequent manifestation of primary lung cancer, soft tissue sarcoma and metastasis. There are no easily accessible data in the literature regarding the correlation between PNX and antibiotics, whereas cases of PNX following chemotherapy have been observed. Only 1-10% of treatment-related adverse events are estimated to be reported to the Food and Drug Administration. The present study described a case of PNX of the left lung in a 70-year-old treatment-naive patient with retroperitoneal liposarcoma. The PNX developed after 8 days of treatment with levofloxacin and after 6 days of piperacillin/tazobactam treatment for a suspicious inflammatory area in the right lung detected by an FDG-PET scan before the patient started chemotherapy. A chest CT scan confirmed the presence of metastasis in the right lung, but neither FDG-PET/CT nor CT showed metastatic disease in the left lung. A total of 14 days after the end of the third cycle of doxorubicin (2 months after the initial diagnosis of PNX), the patient manifested a massive PNX of the right lung. In conclusion, these findings indicated that spontaneous PNX could be linked to the use of some antibiotics.
Collapse
Affiliation(s)
- Manlio Monti
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| | - Francesco Giulio Sullo
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| | - Andrea Prochowski Iamurri
- Radiology Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| | - Caterina Gianni
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| | - Paolo Silimbani
- Oncology Pharmacy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| | - Giulia Bartolini
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| | - Martina Valgiusti
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| | - Luca Esposito
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| | - Daniela Montanari
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| | - Stefano Antonini
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| | - Giovanni Luca Frassineti
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) ‘Dino Amadori’, I-47014 Meldola, Italy
| |
Collapse
|
26
|
Pocock H, Deakin CD, Lall R, Smith CM, Perkins GD. Effectiveness of alternative shock strategies for out-of-hospital cardiac arrest: A systematic review. Resusc Plus 2022; 10:100232. [PMID: 35602465 PMCID: PMC9114679 DOI: 10.1016/j.resplu.2022.100232] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/21/2022] [Revised: 03/18/2022] [Accepted: 04/02/2022] [Indexed: 11/24/2022] Open
Abstract
Aim To determine the optimal first-shock energy level for biphasic defibrillation and whether fixed or escalating protocols for subsequent shocks are most effective. Methods We searched Medline, Embase, Cochrane CENTRAL, CINAHL, the Web of Science and national and international trial registry databases for papers published from database inception to January 2022. We reviewed reference lists of key papers to identify additional references. The population included adults sustaining non traumatic out-of-hospital cardiac arrest subject to attempted defibrillation. Studies of internal or monophasic defibrillation and studies other than randomised controlled trials or prospective cohorts were excluded. Two reviewers assessed study relevance. Data extraction and risk of bias assessment, using the ROBINS-I tool, were conducted by one reviewer and checked by a second reviewer. Data underwent intention-to-treat analysis. Results We identified no studies evaluating first shock energy. Only one study (n = 738) comparing fixed versus escalating energy met eligibility criteria: a prospective cohort analysis of a randomised controlled trial of manual versus mechanical CPR. High fixed (360 J) energy was compared with an escalating (200-200/300-360 J) strategy. Researchers found 27.5% (70/255) of patients in the escalating energy group and 27.61% (132/478) in the fixed high energy group survived to hospital discharge (unadjusted risk ratio 0.99, 95% CI 0.73, 1.23). Results were of very low certainty as the study was at serious risk of bias. Conclusion This systematic review did not identify an optimal first-shock energy for biphasic defibrillation. We identified no survival advantage at 30 days when comparing 360 J fixed with 200 J escalating strategy.
Collapse
Affiliation(s)
- Helen Pocock
- Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, United Kingdom
- South Central Ambulance Service NHS Foundation Trust, Southern House, Sparrowgrove, Otterbourne, Winchester SO21 2RU, United Kingdom
| | - Charles D Deakin
- South Central Ambulance Service NHS Foundation Trust, Southern House, Sparrowgrove, Otterbourne, Winchester SO21 2RU, United Kingdom
- University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, United Kingdom
| | - Ranjit Lall
- Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, United Kingdom
| | - Christopher M Smith
- Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, United Kingdom
| | - Gavin D Perkins
- Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, United Kingdom
- University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital, Bordesley Green East, Birmingham B9 5SS, United Kingdom
| |
Collapse
|
27
|
Molano AP, Hutchison CA, Sanchez R, Rivera AS, Buitrago G, Dazzarola MP, Munevar M, Guerrero M, Vesga JI, Sanabria M. Medium Cut-Off Versus High-Flux Hemodialysis Membranes and Clinical Outcomes: A Cohort Study Using Inverse Probability Treatment Weighting. Kidney Med 2022; 4:100431. [PMID: 35492142 PMCID: PMC9044098 DOI: 10.1016/j.xkme.2022.100431] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022] Open
Abstract
Rationale & Objective This study investigated the effects on patients’ outcomes of using medium cutoff (MCO) versus high-flux (HF) dialysis membranes. Study Design A retrospective, observational, multicenter, cohort study. Setting & Participants Patients aged greater than 18 years receiving hemodialysis at the Baxter Renal Care Services dialysis network in Colombia. The inception of the cohort occurred from September 1, 2017, to November 30, 2017, with follow-up to November 30, 2019. Exposure The patients were divided into 2 cohorts according to the dialyzer used at the inception: (1) MCO membrane or (2) HF membrane. Outcomes Primary outcomes were the hospitalization rate from any cause and hospitalization days per patient-year. Secondary outcomes were acute cardiovascular events and mortality rates from any cause and secondary to cardiovascular causes. Laboratory parameters were assessed throughout the 2-year follow-up period. Analytical Approach Descriptive statistics were used to report population characteristics. Inverse probability of treatment weighting was applied to each group before analysis. All categorical variables were compared using Pearson’s χ2 test, and continuous variables were analyzed with the t test. Baseline differences between groups with a value of >10% were considered clinically meaningful. Laboratory variables were measured at 5 consecutive time points. A between-patient effect was analyzed using a split-plot factorial analysis of variance. Results The analysis included 1,098 patients, of whom 564 (51.3%) were dialyzed with MCO membranes and 534 (48.7%) with HF membranes. Patients receiving hemodialysis with MCO membranes had a lower all-cause hospitalization incidence rate (IR) per patient-year (IR = 0.93; 95% CI, 0.82-1.03) than those receiving hemodialysis with HF membranes (IR = 1.13; 95% CI, 0.96-1.30), corresponding to a significant incident rate ratio (MCO/HF) of 0.82 (95% CI, 0.68-0.99; P = 0.04). The frequency of nonfatal cardiovascular events showed statistical significance, with a lower incidence in the MCO group (incident rate ratio = 0.66; 95% CI, 0.46-0.96; P = 0.03). No statistically significant differences in all-cause time until death were observed (P = 0.48). Albumin levels were similar between the 2 dialyzer cohorts. Limitations Despite the robust statistical analysis, there remains the possibility that unmeasured variables may still generate residual imbalance and, therefore, skew the results. Conclusions The incidences of hospitalization and cardiovascular events in patients receiving hemodialysis were lower when dialyzed with MCO membranes than HF membranes. A randomized controlled trial would be desirable to confirm these results. Trial Registration Clinical Trials.gov, ISRCTN12403265.
Collapse
Affiliation(s)
| | - Colin A. Hutchison
- Department of Medicine, Hawke’s Bay District Health Board, Hastings, New Zealand
| | - Ricardo Sanchez
- Clinical Research Institute, School of Medicine, National University of Colombia, Bogotá, DC, Colombia
| | | | - Giancarlo Buitrago
- Clinical Research Institute, School of Medicine, National University of Colombia, Bogotá, DC, Colombia
| | - María P. Dazzarola
- Baxter Renal Care Services–Servicios de Terapia Renal del Valle, Cali, Colombia
| | - Mario Munevar
- Baxter Renal Care Services–Sucursal Barranquilla, Barranquilla, Colombia
| | - Mauricio Guerrero
- Baxter Renal Care Services–Sucursal Barranquilla, Barranquilla, Colombia
| | | | - Mauricio Sanabria
- Baxter Renal Care Services–Latin America, Bogotá, DC, Colombia
- Address for Correspondence: Mauricio Sanabria, MSc, Baxter Renal Care Services–Latin America, Transversal 23 # 97-73, 6th Floor, Bogotá 110221002, Colombia.
| |
Collapse
|
28
|
Jinhuan Y, Yi W, Yuanwen Z, Delin M, Xiaotian C, Yan W, Liming D, Haitao Y, Lijun W, Tuo D, Kaiyu C, Jiawei H, Chongming Z, Daojie W, Bin J, Gang C. Laparoscopic Versus Open Surgery for Early-Stage Intrahepatic Cholangiocarcinoma After Mastering the Learning Curve: A Multicenter Data-Based Matched Study. Front Oncol 2022; 11:742544. [PMID: 35070961 PMCID: PMC8777042 DOI: 10.3389/fonc.2021.742544] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/16/2021] [Accepted: 12/08/2021] [Indexed: 12/20/2022] Open
Abstract
BACKGROUND Surgical resection is the only widely accepted curative method for intrahepatic cholangiocarcinoma (ICC). However, little is known about the efficacy of laparoscopic liver resection for ICC, especially in patients with early-stage disease. The aim of this study was to compare the short-term and long-term effects of laparoscopy and open surgery for the treatment of ICC. METHODS Data from 1,084 patients treated at three hospitals from January 2011 to December 2018 were selected and analyzed. Propensity score matching was performed to compare the long-term outcomes (overall survival and recurrence-free survival) and short-term outcomes (perioperative outcomes) of all-stage and early-stage patients. RESULTS After matching, 244 patients (122 vs. 122) in the all-stage group and 65 patients (27 vs. 38) in the early-stage group were included. The baseline of the two groups was balanced, and no significant differences were found in sex or age. The short-term results of the laparoscopic group were better than those of the open group, including less blood loss [blood loss ≥400 ml 27 (22.1%) vs. 6 (4.92%), p<0.001 for all-stage, 12 (31.6%) vs. 2 (7.41%), p=0.042 for early stage), shorter surgery [200 (141; 249) min vs. 125 (115; 222) min, p=0.025 for early stage] and shorter hospital stay [11.0 (9.00; 16.0) days vs. 9.00 (7.00; 12.0) days, p=0.001 for all stage, 11.0 (8.50; 17.8) days vs. 9.00 (6.50; 11.0) days, p=0.011 for early stage]. Regarding long-term outcomes, no significant differences were found for all-stage patients, while there were significant differences observed for the early-stage group (p=0.013 for OS, p=0.014 for RFS). For the early-stage patients, the 1-, 3-, and 5-year OS rates of the OLR group were 84.2, 65.8, and 41.1%, respectively, and those of the LLR group were 100, 90.9, and 90.9%, respectively. The RFS rates of the OLR group were 84.2, 66.7, and 41.7%, respectively, and those of the LLR group were and 92.3, 92.3, and 92.3%, respectively. CONCLUSION Patients treated with laparoscopy seemed to have better short-term outcomes, such as less blood loss, shorter operation duration, and shorter hospital stay, than patients undergoing open surgery. Based on the long-term results, laparoscopic treatment for early ICC may have certain advantages.
Collapse
Affiliation(s)
- Yang Jinhuan
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
| | - Wang Yi
- Department of Epidemiology and Biostatistics, School of Public Health and Management, Wenzhou Medical University, Wenzhou, China
| | - Zheng Yuanwen
- Department of Hepatobiliary Surgery, Shandong Provincial Hospital, Jinan, China
| | - Ma Delin
- Department of Hepatobiliary Surgery, Qilu Hospital of Shandong University, Jinan, China
| | - Chen Xiaotian
- Department of Clinical Medicine, The Second School of Medicine, Wenzhou Medical University, Wenzhou, China
| | - Wang Yan
- Department of Clinical Medicine, The Second School of Medicine, Wenzhou Medical University, Wenzhou, China
| | - Deng Liming
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
| | - Yu Haitao
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
| | - Wu Lijun
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
| | - Deng Tuo
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
| | - Chen Kaiyu
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
| | - Hu Jiawei
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
| | - Zheng Chongming
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
| | - Wang Daojie
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
| | - Jin Bin
- Department of Hepatobiliary Surgery, Qilu Hospital of Shandong University, Jinan, China
| | - Chen Gang
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
| |
Collapse
|
29
|
Kolonics-Farkas AM, Šterclová M, Mogulkoc N, Lewandowska K, Müller V, Hájková M, Kramer M, Jovanovic D, Tekavec-Trkanjec J, Studnicka M, Stoeva N, Littnerová S, Vašáková M. Differences in Baseline Characteristics and Access to Treatment of Newly Diagnosed Patients With IPF in the EMPIRE Countries. Front Med (Lausanne) 2022; 8:729203. [PMID: 35004713 PMCID: PMC8733326 DOI: 10.3389/fmed.2021.729203] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/22/2021] [Accepted: 11/22/2021] [Indexed: 12/12/2022] Open
Abstract
Idiopathic pulmonary fibrosis (IPF) is a rare lung disease with poor prognosis. The diagnosis and treatment possibilities are dependent on the health systems of countries. Hence, comparison among countries is difficult due to data heterogeneity. Our aim was to analyse patients with IPF in Central and Eastern Europe using the uniform data from the European Multipartner IPF registry (EMPIRE), which at the time of analysis involved 10 countries. Newly diagnosed IPF patients (N = 2,492, between March 6, 2012 and May 12, 2020) from Czech Republic (N = 971, 39.0%), Turkey (N = 505, 20.3%), Poland (N = 285, 11.4%), Hungary (N = 216, 8.7%), Slovakia (N = 149, 6.0%), Israel (N = 120, 4.8%), Serbia (N = 95, 3.8%), Croatia (N = 87, 3.5%), Austria (N = 55, 2.2%), and Bulgaria (N = 9, 0.4%) were included, and Macedonia, while a member of the registry, was excluded from this analysis due to low number of cases (N = 5) at this timepoint. Baseline characteristics, smoking habit, comorbidities, lung function values, CO diffusion capacity, high-resolution CT (HRCT) pattern, and treatment data were analysed. Patients were significantly older in Austria than in the Czech Republic, Turkey, Hungary, Slovakia, Israel, and Serbia. Ever smokers were most common in Croatia (84.1%) and least frequent in Serbia (39.2%) and Slovakia (42.6%). The baseline forced vital capacity (FVC) was >80% in 44.6% of the patients, between 50 and 80% in 49.3%, and <50% in 6.1%. Most IPF patients with FVC >80% were registered in Poland (63%), while the least in Israel (25%). A typical usual interstitial pneumonia (UIP) pattern was present in 67.6% of all patients, ranging from 43.5% (Austria) to 77.2% (Poland). The majority of patients received antifibrotic therapy (64.5%); 37.4% used pirfenidone (range 7.4–39.8% between countries); and 34.9% nintedanib (range 12.6–56.0% between countries) treatment. In 6.8% of the cases, a therapy switch was initiated between the 2 antifibrotic agents. Significant differences in IPF patient characteristics and access to antifibrotic therapies exist in EMPIRE countries, which needs further investigation and strategies to improve and harmonize patient care and therapy availability in this region.
Collapse
Affiliation(s)
| | - Martina Šterclová
- Department of Respiratory Diseases of the First Faculty of Medicine Charles University, University Thomayer Hospital, Prague, Czechia
| | - Nesrin Mogulkoc
- Department of Pulmonary Medicine, Ege University Medical School, Izmir, Turkey
| | - Katarzyna Lewandowska
- First Department of Pulmonary Diseases, Institute of Tuberculosis and Lung Diseases, Warsaw, Poland
| | - Veronika Müller
- Department of Pulmonology, Semmelweis University, Budapest, Hungary
| | - Marta Hájková
- Clinic of Pneumology and Phthisiology, University Hospital Bratislava, Bratislava, Slovakia
| | - Mordechai Kramer
- Rabin Medical Center, Institute of Pulmonary Medicine, Petah Tikva, Israel
| | | | | | | | | | - Simona Littnerová
- Faculty of Medicine, Institute of Biostatistics and Analyses, Masaryk University, Brno, Czechia
| | - Martina Vašáková
- Department of Respiratory Diseases of the First Faculty of Medicine Charles University, University Thomayer Hospital, Prague, Czechia
| |
Collapse
|
30
|
Lu ZK, Xiong X, Lee T, Wu J, Yuan J, Jiang B. Big Data and Real-World Data based Cost-Effectiveness Studies and Decision-making Models: A Systematic Review and Analysis. Front Pharmacol 2021; 12:700012. [PMID: 34737696 PMCID: PMC8562301 DOI: 10.3389/fphar.2021.700012] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/25/2021] [Accepted: 08/27/2021] [Indexed: 12/28/2022] Open
Abstract
Background: Big data and real-world data (RWD) have been increasingly used to measure the effectiveness and costs in cost-effectiveness analysis (CEA). However, the characteristics and methodologies of CEA based on big data and RWD remain unknown. The objectives of this study were to review the characteristics and methodologies of the CEA studies based on big data and RWD and to compare the characteristics and methodologies between the CEA studies with or without decision-analytic models. Methods: The literature search was conducted in Medline (Pubmed), Embase, Web of Science, and Cochrane Library (as of June 2020). Full CEA studies with an incremental analysis that used big data and RWD for both effectiveness and costs written in English were included. There were no restrictions regarding publication date. Results: 70 studies on CEA using RWD (37 with decision-analytic models and 33 without) were included. The majority of the studies were published between 2011 and 2020, and the number of CEA based on RWD has been increasing over the years. Few CEA studies used big data. Pharmacological interventions were the most frequently studied intervention, and they were more frequently evaluated by the studies without decision-analytic models, while those with the model focused on treatment regimen. Compared to CEA studies using decision-analytic models, both effectiveness and costs of those using the model were more likely to be obtained from literature review. All the studies using decision-analytic models included sensitivity analyses, while four studies no using the model neither used sensitivity analysis nor controlled for confounders. Conclusion: The review shows that RWD has been increasingly applied in conducting the cost-effectiveness analysis. However, few CEA studies are based on big data. In future CEA studies using big data and RWD, it is encouraged to control confounders and to discount in long-term research when decision-analytic models are not used.
Collapse
Affiliation(s)
- Z Kevin Lu
- Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, SC, United States
| | - Xiaomo Xiong
- Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, SC, United States
| | - Taiying Lee
- Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, SC, United States
| | - Jun Wu
- Department of Pharmaceutical and Administrative Sciences, Presbyterian College School of Pharmacy, Clinton, SC, United States
| | - Jing Yuan
- Department of Clinical Pharmacy, School of Pharmacy, Fudan University, Shanghai, China
| | - Bin Jiang
- Department of Administrative and Clinical Pharmacy, School of Pharmaceutical Sciences, Health Science Center, Peking University, Beijing, China
| |
Collapse
|
31
|
Chen D, Fulmer C, Gordon IO, Syed S, Stidham RW, Vande Casteele N, Qin Y, Falloon K, Cohen BL, Wyllie R, Rieder F. Application of Artificial Intelligence to Clinical Practice in Inflammatory Bowel Disease - What the Clinician Needs to Know. J Crohns Colitis 2021; 16:460-471. [PMID: 34558619 PMCID: PMC8919817 DOI: 10.1093/ecco-jcc/jjab169] [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] [Indexed: 12/12/2022]
Abstract
Artificial intelligence [AI] techniques are quickly spreading across medicine as an analytical method to tackle challenging clinical questions. What were previously thought of as highly complex data sources, such as images or free text, are now becoming manageable. Novel analytical methods merge the latest developments in information technology infrastructure with advances in computer science. Once primarily associated with Silicon Valley, AI techniques are now making their way into medicine, including in the field of inflammatory bowel diseases [IBD]. Understanding potential applications and limitations of these techniques can be difficult, in particular for busy clinicians. In this article, we explain the basic terminologies and provide a particular focus on the foundations behind state-of-the-art AI methodologies in both imaging and text. We explore the growing applications of AI in medicine, with a specific focus on IBD to inform the practising gastroenterologist and IBD specialist. Finally, we outline possible future uses of these technologies in daily clinical practice.
Collapse
Affiliation(s)
- David Chen
- Medical Operations, Cleveland Clinic Foundation, Cleveland, OH, USA,Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
| | - Clifton Fulmer
- Department of Pathology, Robert J. Tomsich Pathology and Laboratory Medicine Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
| | - Ilyssa O Gordon
- Department of Pathology, Robert J. Tomsich Pathology and Laboratory Medicine Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
| | - Sana Syed
- Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, School of Medicine, University of Virginia, Charlottesville, VA, USA,School of Data Science, University of Virginia, Charlottesville, VA, USA
| | - Ryan W Stidham
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Michigan Medicine, Ann Arbor, MI, USA,Department of Computational Medicine and Bioinformatics, University of Michigan, Ann Arbor, MI, USA
| | | | - Yi Qin
- Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
| | - Katherine Falloon
- Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
| | - Benjamin L Cohen
- Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
| | - Robert Wyllie
- Medical Operations, Cleveland Clinic Foundation, Cleveland, OH, USA,Department of Pediatric Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic Foundation, Cleveland, OH, USA
| | - Florian Rieder
- Corresponding author: Florian Rieder, MD, Department of Inflammation and Immunity, and Department of Gastroenterology, Hepatology, & Nutrition, Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44195, USA. Tel: (216) 445-5631; Fax: (216) 636-0104; E-mail:
| |
Collapse
|
32
|
De Souza E, Anderson TA. Pediatric Perioperative Methadone Dosing Trial: An Illustration of the Challenges in Conducting High-Quality Pediatric Anesthesia Research. Anesth Analg 2021; 133:324-326. [PMID: 34257193 DOI: 10.1213/ane.0000000000005453] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Affiliation(s)
- Elizabeth De Souza
- From the Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California
| | | |
Collapse
|
33
|
Huang Y, Yuan W, Kohane IS, Beaulieu-Jones BK. Illustrating potential effects of alternate control populations on real-world evidence-based statistical analyses. JAMIA Open 2021; 4:ooab045. [PMID: 34142018 PMCID: PMC8206406 DOI: 10.1093/jamiaopen/ooab045] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2021] [Revised: 05/06/2021] [Indexed: 11/14/2022] Open
Abstract
Objective Case-control study designs are commonly used in retrospective analyses of real-world evidence (RWE). Due to the increasingly wide availability of RWE, it can be difficult to determine whether findings are robust or the result of testing multiple hypotheses. Materials and Methods We investigate the potential effects of modifying cohort definitions in a case-control association study between depression and type 2 diabetes mellitus. We used a large (>75 million individuals) de-identified administrative claims database to observe the effects of minor changes to the requirements of glucose and hemoglobin A1c tests in the control group. Results We found that small permutations to the criteria used to define the control population result in significant shifts in both the demographic structure of the identified cohort as well as the odds ratio of association. These differences remain present when testing against age- and sex-matched controls. Discussion Analyses of RWE need to be carefully designed to avoid issues of multiple testing. Minor changes to control cohorts can lead to significantly different results and have the potential to alter even prospective studies through selection bias. Conclusion We believe this work offers strong support for the need for robust guidelines, best practices, and regulations around the use of observational RWE for clinical or regulatory decision-making.
Collapse
Affiliation(s)
- Yidi Huang
- Department of Biomedical Informatics, Harvard Medical School, Countway Library, Boston, Massachusetts, USA
| | - William Yuan
- Department of Biomedical Informatics, Harvard Medical School, Countway Library, Boston, Massachusetts, USA
| | - Isaac S Kohane
- Department of Biomedical Informatics, Harvard Medical School, Countway Library, Boston, Massachusetts, USA
| | - Brett K Beaulieu-Jones
- Department of Biomedical Informatics, Harvard Medical School, Countway Library, Boston, Massachusetts, USA
| |
Collapse
|
34
|
Mospan AR, Morris HL, Fried MW. Real-world evidence in hepatocellular carcinoma. Liver Int 2021; 41 Suppl 1:61-67. [PMID: 34155788 DOI: 10.1111/liv.14864] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/28/2021] [Accepted: 02/28/2021] [Indexed: 12/19/2022]
Abstract
Real-world evidence includes all health-related information, such as electronic health records, insurance claims, pharmacy records and wearables that are obtained outside of clinical trials. These data can provide critical insights into the natural history of disease and evaluate the safety and effectiveness of treatment regimens used in clinical practice. Real-world data have been applied to varying degrees by global regulatory agencies to inform and expedite many phases of drug development and help refine the use of therapeutic regimens after marketing, especially in populations that are under-represented in registration trials. For the management of hepatocellular carcinoma, early detection provides the best chance for curative therapies, whose success has been evaluated in numerous cohorts. The availability of novel systemic therapies, including kinase inhibitors and immunotherapies, has provided new treatment options and improved survival in patients with advanced stage hepatocellular carcinoma. Real-world longitudinal observational studies can help understand the long-term safety and effectiveness of these agents.
Collapse
Affiliation(s)
| | | | - Michael W Fried
- Target RWE, Durham, NC, USA.,Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, NC, USA
| |
Collapse
|
35
|
Mehyar L, Sandler J, Thiruvenkatachari B. Does observational study on the effectiveness of the Twin Blocks overestimate or underestimate the results? A comparative analysis of retrospective samples versus randomized controlled trial. J World Fed Orthod 2021; 10:43-48. [PMID: 33893064 DOI: 10.1016/j.ejwf.2021.03.002] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2020] [Revised: 03/17/2021] [Accepted: 03/17/2021] [Indexed: 11/25/2022]
Abstract
BACKGROUND AND OBJECTIVES Class II malocclusion is one of the most common orthodontic problems. The Twin Block appliance has proven to be the most popular appliance for the correction of these malocclusions. Although randomized controlled trials (RCTs) on the Twin Block appliance have reported the changes to be mainly dentoalveolar, several nonrandomized studies have reported a significant skeletal improvement in these patients. Hence, the aim of this study was to compare the effectiveness of Twin Block appliance evaluated using an RCT or retrospectively selected cases (RSC) for the treatment of Class II Division 1 malocclusion in an adolescent population. METHODS This was a retrospective study. The results for an RCT were selected from a UK Class II multicenter study. Sixty-three patients from the trial were included. This group was matched with retrospectively selected Class II cases treated with a Twin Block functional appliance and their results submitted for Membership in Orthodontics examination in the United Kingdom, from four centers. The primary outcome was skeletal measurement ANB (A point, nasion, B point). Secondary outcomes included final peer assessment rating (PAR) scores and final overjet. Intrarater reliability of measurements was assessed. Independent samples t-test was carried out to look at the difference between the groups. RESULTS The reliability assessment showed excellent agreement for all measurements. The data were normally distributed. There was a statistically significant difference favoring the RSC group for final overjet (mean difference [MD] = 1.068, 95% confidence interval [CI] -0.67 to 1.47, P = 0.000) and final PAR (MD = 4.0, 95% CI -0.79 to 5.5, P = 0.000). There was no significant difference in the scores for final ANB (MD = 0.34, 95% CI -0.39 to 1.07, P = 0.33). CONCLUSION The RSCs show significantly improved overjet and PAR scores at the end of treatment and no statistically significant difference for skeletal change. The study raises the question of a potential role of observational studies in evaluating the effect of an intervention in orthodontics.
Collapse
Affiliation(s)
- Layan Mehyar
- Former Specialist Trainee in Orthodontics, School of Dentistry, The University of Manchester, Manchester, United Kingdom
| | - Jonathan Sandler
- Professor in Orthodontics, Consultant Orthodontist, Chesterfield Royal Hospital NHS Trust, Calow, Chesterfield, United Kingdom
| | - Badri Thiruvenkatachari
- Hon. Senior Lecturer/Consultant in Orthodontics, School of Dentistry, University of Manchester, Manchester, United Kingdom.
| |
Collapse
|
36
|
Review of Current Real-World Experience with Teriparatide as Treatment of Osteoporosis in Different Patient Groups. J Clin Med 2021; 10:jcm10071403. [PMID: 33915736 PMCID: PMC8037129 DOI: 10.3390/jcm10071403] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2021] [Revised: 03/14/2021] [Accepted: 03/19/2021] [Indexed: 12/17/2022] Open
Abstract
Teriparatide has proven effective in reducing both vertebral and non-vertebral fractures in clinical trials of post-menopausal and glucocorticoid-induced osteoporosis. Widespread adoption of Teriparatide over the last two decades means that there is now substantial experience of its use in routine clinical practice, which is summarized in this paper. Extensive real-world experience of Teriparatide in post-menopausal osteoporosis confirms the fracture and bone density benefits seen in clinical trials, with similar outcomes identified also in male and glucocorticoid-induced osteoporosis. Conversely, very limited experience has been reported in pre-menopausal osteoporosis or in the use of Teriparatide in combination with other therapies. Surveillance studies have identified no safety signals relating to the possible association of Teriparatide with osteosarcoma. We also review the evidence for predicting response to Teriparatide in order to inform the debate on where best to use Teriparatide in an increasingly crowded therapeutic landscape.
Collapse
|
37
|
Ottaiano A, Scala S, Santorsola M, Trotta AM, D'Alterio C, Portella L, Clemente O, Nappi A, Zanaletti N, De Stefano A, Avallone A, Granata V, Notariello C, Luce A, Lombardi A, Picone C, Petrillo A, Perri F, Tatangelo F, Di Mauro A, Albino V, Izzo F, Rega D, Pace U, Di Marzo M, Chiodini P, De Feo G, Del Prete P, Botti G, Delrio P, Caraglia M, Nasti G. Aflibercept or bevacizumab in combination with FOLFIRI as second-line treatment of mRAS metastatic colorectal cancer patients: the ARBITRATION study protocol. Ther Adv Med Oncol 2021; 13:1758835921989223. [PMID: 33854566 PMCID: PMC8010802 DOI: 10.1177/1758835921989223] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2020] [Accepted: 12/31/2020] [Indexed: 11/16/2022] Open
Abstract
Background: The intensive study of predictive factors has strongly ameliorated the therapeutic flow-chart of metastatic colorectal cancer (mCRC) by allowing the selection of patients who benefit from specific therapies. For instance, in mRAS (mutated RAS) mCRC patients, anti-EGFR drugs (cetuximab and panitumumab) are not recommended; in this group of patients, the use of anti-angiogenic drugs (bevacizumab and aflibercept) is predominant. However, at progression to standard bevacizumab-based first-line chemotherapy, still to date, there are no studies to guide oncologists in the choice of the best second-line anti-angiogenic drug (bevacizumab beyond progression versus aflibercept). Methods: ARBITRATION is a prospective, observational study assessing efficacy differences between second-line fluorouracil/irinotecan (FOLFIRI)/bevacizumab versus FOLFIRI/aflibercept at progression to fluoropyrimidines, oxaliplatin and bevacizumab in mRAS mCRC patients. A test power of 80%, a median survival of 9 months from second-line treatment start and a hazard ratio of 0.67 between the two schedules were the basis for statistical design. The final sample will be 220 patients (110 per treatment). The significance will be verified with a two-tailed log-rank test with an alpha value of the I-type error of 5%. Time-to-outcome will be described by Kaplan–Meier curves and prognostic factors studied through multivariable analyses based on the Cox model. Secondary objectives include safety, responses’ duration and progression-free survival. A translational research will be conducted to measure several angiogenic proteins in patients’ serum before starting the therapy in order to evidence any angiogenic factor patterns related to outcome. Discussion: We present a large, prospective, observational study aiming to answer two scientific questions: (1) outcome differences between second-line treatments with FOLFIRI/bevacizumab beyond progression versus FOLFIRI/aflibercept in mRAS mCRC patients, (2) angiogenic factors’ patterns that could associate with efficacy and help oncologists to apply best the therapeutic anti-angiogenic strategies. Trial registration: The ARBITRATION trial (version 0.0, 13 April 2020) has been registered into the clinicaltrials.gov registry on 20 May 2020 with identifier NCT04397601.
Collapse
Affiliation(s)
- Alessandro Ottaiano
- Innovative Therapies for Abdominal Metastases Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", via M. Semmola, Naples, Campania 80131, Italy
| | - Stefania Scala
- Functional Genomics, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Mariachiara Santorsola
- Innovative Therapies for Abdominal Metastases Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Anna Maria Trotta
- Functional Genomics, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Crescenzo D'Alterio
- Functional Genomics, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Luigi Portella
- Functional Genomics, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Ottavia Clemente
- Department of Abdominal Oncology, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Anna Nappi
- Department of Abdominal Oncology, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Nicoletta Zanaletti
- Department of Abdominal Oncology, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Alfonso De Stefano
- Department of Abdominal Oncology, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Antonio Avallone
- Department of Abdominal Oncology, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Vincenza Granata
- Department of Radiology, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Carmen Notariello
- Department of Abdominal Oncology, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Amalia Luce
- Department of Precision Medicine, University of Campania "L. Vanvitelli", Naples, Italy Biogem Scarl, Institute of Genetic Research, Laboratory of Precision and Molecular Oncology, Ariano Irpino, Italy
| | - Angela Lombardi
- Department of Precision Medicine, University of Campania "L. Vanvitelli", Naples, Italy Biogem Scarl, Institute of Genetic Research, Laboratory of Precision and Molecular Oncology, Ariano Irpino, Italy
| | - Carmine Picone
- Department of Radiology, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Antonella Petrillo
- Department of Radiology, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Francesco Perri
- Head and Neck Cancer Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Fabiana Tatangelo
- Pathology Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Annabella Di Mauro
- Pathology Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Vittorio Albino
- Hepatobiliary Surgical Oncology Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Francesco Izzo
- Hepatobiliary Surgical Oncology Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Daniela Rega
- Colorectal Cancer Surgery Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Ugo Pace
- Colorectal Cancer Surgery Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Massimiliano Di Marzo
- Colorectal Cancer Surgery Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Paolo Chiodini
- Medical Statistics Unit, University of Campania, Luigi Vanvitelli, Naples, Italy
| | - Gianfranco De Feo
- Scientific Directorate, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Paola Del Prete
- Scientific Directorate, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Gerardo Botti
- Scientific Directorate, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Paolo Delrio
- Colorectal Cancer Surgery Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| | - Michele Caraglia
- Department of Precision Medicine, University of Campania "L. Vanvitelli", Naples, Italy Biogem Scarl, Institute of Genetic Research, Laboratory of Precision and Molecular Oncology, Ariano Irpino, Italy
| | - Guglielmo Nasti
- Innovative Therapies for Abdominal Metastases Unit, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy
| |
Collapse
|
38
|
Alemi F, Aljuaid M, Durbha N, Yousefi M, Min H, Sylvia LG, Nierenberg AA. A surrogate measure for patient reported symptom remission in administrative data. BMC Psychiatry 2021; 21:121. [PMID: 33663440 PMCID: PMC7931356 DOI: 10.1186/s12888-021-03133-1] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/01/2020] [Accepted: 02/16/2021] [Indexed: 01/12/2023] Open
Abstract
BACKGROUND In real-world pragmatic administrative databases, patient reported remission is often missing. OBJECTIVE We evaluate if, in administrative data, five features of antidepressant use patterns can replace patient-reported symptom remission. METHOD We re-examined data from Sequence Treatment Alternatives to Relieve Depression (STAR*D) study. Remission was measured using 50% reduction in Hamilton index. Pattern of antidepressant use was examined through five variables: (a) number of prior ineffective antidepressants, (b) duration of taking current antidepressant, (c) receiving therapeutic dose of the medication, and (d) switching to another medication, or (e) augmenting with another antidepressant. The likelihood ratio (LR) associated with each of these predictors was assessed in 90% of data (3329 cases) and evaluated in 10% of data (350 cases) set-aside for evaluation. The accuracy of predictions was calculated using Area under the Receiver Operating Curve (AROC). RESULTS Patients who took antidepressants for 14 weeks (LR = 2.007) were more likely to have symptom remission. Prior use of 3 antidepressants reduced the odds of remission (LR = 0.771). Patients who received antidepressants below therapeutic dose were 5 times less likely to experience remission (LR = 0.204). Antidepressant that were augment or switched, almost never led to remission (LR = 0.008, LR = 0.002 respectively). Patterns of antidepressant use accurately (AROC = 0.93) predicted symptom remission. CONCLUSION Within the first 100 days, antidepressants use patterns could serve as a surrogate measure for patient-reported remission of symptoms.
Collapse
Affiliation(s)
- Farrokh Alemi
- Dept. of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, USA.
| | - Mai Aljuaid
- grid.22448.380000 0004 1936 8032Dept. of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, USA
| | - Naren Durbha
- grid.22448.380000 0004 1936 8032Dept. of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, USA
| | - Melanie Yousefi
- grid.22448.380000 0004 1936 8032School of Nursing, College of Health and Human Services, George Mason University, Fairfax, USA
| | - Hua Min
- grid.22448.380000 0004 1936 8032Dept. of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, USA
| | - Louisa G. Sylvia
- grid.32224.350000 0004 0386 9924Dauten Family Center for Bipolar Treatment Innovation, Department of Psychiatry, Massachusetts General Hospital, Boston, MA USA ,grid.38142.3c000000041936754XHarvard Medical School, Boston, MA USA
| | - Andrew A. Nierenberg
- grid.32224.350000 0004 0386 9924Dauten Family Center for Bipolar Treatment Innovation, Department of Psychiatry, Massachusetts General Hospital, Boston, MA USA ,grid.38142.3c000000041936754XHarvard Medical School, Boston, MA USA
| |
Collapse
|
39
|
Long-term maxillary anteroposterior changes following maxillary protraction with or without expansion: A meta-analysis and meta-regression. PLoS One 2021; 16:e0247027. [PMID: 33617540 PMCID: PMC7899359 DOI: 10.1371/journal.pone.0247027] [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: 04/24/2020] [Accepted: 01/29/2021] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Maxillary protraction with or without expansion is a widely known orthopedic treatment modality in growing skeletal Class III patients. However, limited data are available regarding the outcomes of long-term changes in the maxilla. Aim of this meta-analysis was to assess the effectiveness of the long-term maxillary anteroposterior changes following a facemask therapy with or without rapid maxillary expansion in growing skeletal Class III patients. METHODS A comprehensive literature search was conducted using the databases of PubMed, Science Direct, Web of Science, and Embase. Randomized controlled trials and cohort studies, published up to Sep. 2020, with maxillary protraction and/or expansion as keywords were included in this meta-analysis. Risk of bias within and across studies were assessed using the Cochrane tools (RoB2.0 and ROBINS-I) and GRADE approach. Overall and subgroup comparisons with the random-effect model were performed in this meta-analysis. Meta-regression models were designed to determine potential heterogeneity. RESULTS There was a statistically significant increase (Mean difference, 2.29°; 95% confidence interval, 1.86-2.73; and p < 0.001 after facemask (FM) protraction. Mean difference, 1.73°; 95% confidence interval, 1.36-2.11; and p < 0.001 after rapid maxillary expansion(RME) and facemask protraction) in the Sella-Nasion-A point (SNA) angle in the treatment groups as compared with the control groups, when measured during the less than 3-year follow-up period. However, no statistically significant changes (Mean difference, 0.28°; 95% confidence interval, -0.57-1.13; and p = 0.52 after facemask protraction. Mean difference, 0.34°; 95% confidence interval, -0.64-1.33; and p = 0.50 after rapid maxillary expansion and facemask protraction) were observed in the SNA angle in the groups, when measured after 3 years of follow-up. Meta-regression analysis also showed that with increased follow-up duration, the effectiveness of maxillary protraction decreased. CONCLUSION This meta-analysis revealed that maxillary protraction therapy could be effective for a short-term in correcting maxillary hypoplasia and the treatment result was not affected by mean age and sex. However, with increased follow-up duration, the sagittal maxillary changes gradually decreased. Limitations on this review were only the SNA angle was used and clinical heterogeneity was not discussed. The quality of evidence was moderate. Further long-term observational studies are necessary for a comprehensive evaluation of the effects on maxillary skeletal changes.
Collapse
|
40
|
Weymann D, Laskin J, Jones SJ, Lim H, Renouf DJ, Roscoe R, Schrader KA, Sun S, Yip S, Marra MA, Regier DA. Matching methods in precision oncology: An introduction and illustrative example. Mol Genet Genomic Med 2021; 9:e1554. [PMID: 33237632 PMCID: PMC7963415 DOI: 10.1002/mgg3.1554] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/08/2020] [Revised: 08/25/2020] [Accepted: 10/29/2020] [Indexed: 12/29/2022] Open
Abstract
BACKGROUND Randomized controlled trials (RCTs) are uncommon in precision oncology. We provide an introduction and illustrative example of matching methods for evaluating precision oncology in the absence of RCTs. We focus on British Columbia's Personalized OncoGenomics (POG) program, which applies whole-genome and transcriptome analysis (WGTA) to inform advanced cancer care. METHODS Our cohort comprises 230 POG patients enrolled between 2014 and 2015 and matched POG-naive controls. We generated our matched cohort using 1:1 propensity score matching (PSM) and genetic matching prior to exploring survival differences. RESULTS We find that genetic matching outperformed PSM when balancing covariates. In all cohorts, overall survival did not significantly differ across POG and POG-naive patients (p > 0.05). Stratification by WGTA-informed treatment indicated unmatched survival differences. Patients whose WGTA information led to treatment change were at a reduced hazard of death compared to POG-naive controls in all cohorts, with estimated hazard ratios ranging from 0.33 (95% CI: 0.13, 0.81) to 0.41 (95% CI: 0.17, 0.98). CONCLUSION These results signal that clinical effectiveness of precision oncology approaches will depend on rates of genomics-informed treatment change. Our study will guide future evaluations of precision oncology and support reliable effect estimation when RCT data are unavailable.
Collapse
Affiliation(s)
- Deirdre Weymann
- Canadian Centre for Applied Research in Cancer Control, Cancer Control ResearchBC CancerVancouverBCCanada
| | - Janessa Laskin
- Division of Medical OncologyBC CancerVancouverBCCanada
- Department of MedicineFaculty of MedicineUniversity of British ColumbiaVancouverBCCanada
| | - Steven J.M. Jones
- Canada's Michael Smith Genome Sciences CentreBC CancerVancouverBCCanada
- Department of Medical GeneticsFaculty of MedicineUniversity of British ColumbiaVancouverBCCanada
| | - Howard Lim
- Division of Medical OncologyBC CancerVancouverBCCanada
- Department of MedicineFaculty of MedicineUniversity of British ColumbiaVancouverBCCanada
| | - Daniel J. Renouf
- Division of Medical OncologyBC CancerVancouverBCCanada
- Department of MedicineFaculty of MedicineUniversity of British ColumbiaVancouverBCCanada
| | - Robyn Roscoe
- Canada's Michael Smith Genome Sciences CentreBC CancerVancouverBCCanada
| | - Kasmintan A. Schrader
- Department of Medical GeneticsFaculty of MedicineUniversity of British ColumbiaVancouverBCCanada
- Department of Molecular OncologyBC CancerVancouverBCCanada
| | - Sophie Sun
- Division of Medical OncologyBC CancerVancouverBCCanada
- Department of MedicineFaculty of MedicineUniversity of British ColumbiaVancouverBCCanada
| | - Stephen Yip
- Department of Pathology & Laboratory MedicineFaculty of MedicineUniversity of British ColumbiaVancouverBCCanada
- Department of PathologyBC CancerVancouverBCCanada
| | - Marco A. Marra
- Canada's Michael Smith Genome Sciences CentreBC CancerVancouverBCCanada
- Department of Medical GeneticsFaculty of MedicineUniversity of British ColumbiaVancouverBCCanada
| | - Dean A. Regier
- Canadian Centre for Applied Research in Cancer Control, Cancer Control ResearchBC CancerVancouverBCCanada
- School of Population and Public HealthUniversity of British ColumbiaVancouverBCCanada
| |
Collapse
|
41
|
Chan MMY, Han YMY. The Effect of Transcranial Direct Current Stimulation in Changing Resting-State Functional Connectivity in Patients With Neurological Disorders: A Systematic Review. J Cent Nerv Syst Dis 2020; 12:1179573520976832. [PMID: 33402860 PMCID: PMC7745554 DOI: 10.1177/1179573520976832] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/14/2020] [Accepted: 11/03/2020] [Indexed: 01/08/2023] Open
Abstract
BACKGROUND People with neurological disorders are found to have abnormal resting-state functional connectivity (rsFC), which is associated with the persistent functional impairment found in these patients. Recently, transcranial direct current stimulation (tDCS) has been shown to improve rsFC, although the results are inconsistent. OBJECTIVE We hope to explore whether tDCS induces rsFC changes among patients with neurological disorders, whether rsFC is clinically relevant and how different tDCS parameters affect rsFC outcome among these individuals. METHODS A systematic review was conducted according to PRISMA guidelines (systematic review registration number: CRD42020168654). Randomized controlled trials that studied the tDCS effects on rsFC between the experimental and sham-controlled groups using either electrophysiological or neuroimaging methods were included. RESULTS Active tDCS can induce changes in both localized (ie, brain regions under the transcranial electrodes) and diffused (ie, brain regions not directly influenced by the transcranial electrodes) rsFC. Interestingly, fMRI studies showed that the default mode network was enhanced regardless of patients' diagnoses, the stimulation paradigms used or the rsFC analytical methods employed. Second, stimulation intensity, but not total stimulation time, appeared to positively influence the effect of tDCS on rsFC. LIMITATIONS AND CONCLUSION Due to the inherent heterogeneity in rsFC analytical methods and tDCS protocols, meta-analysis was not conducted. We recommend that future studies may investigate the effect of tDCS on rsFC for repeated cathodal stimulation. For clinicians, we suggest anodal stimulation at a higher stimulation intensity within the safety limit may maximize tDCS effects in modulating aberrant functional connectivity of patients with neurological disorders.
Collapse
Affiliation(s)
- Melody MY Chan
- Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China
| | - Yvonne MY Han
- Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China
| |
Collapse
|
42
|
Cost-Effectiveness of Tiotropium in Elderly Patients with Severe Asthma Using Real-World Data. THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE 2020; 9:1939-1947.e7. [PMID: 33307277 DOI: 10.1016/j.jaip.2020.11.052] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Subscribe] [Scholar Register] [Received: 06/03/2020] [Revised: 10/29/2020] [Accepted: 11/22/2020] [Indexed: 01/01/2023]
Abstract
BACKGROUND Tiotropium has the potential to alleviate asthmatic symptoms caused by the aging of lungs. However, few studies have focused on specific treatments for elderly patients with asthma. OBJECTIVES To estimate the cost-effectiveness of adding tiotropium to inhaled corticosteroids and long-acting beta-agonists in elderly patients with severe asthma using real-world data. METHODS Phase I was a retrospective cohort study using the National Health Insurance claims data to measure clinical and economic outcomes. In phase II, a Markov model was constructed to evaluate cost-effectiveness from Korean health care system perspective, based on phase I, including 2 health states, and an asthma exacerbation event. We estimated cost given in 2018 US dollars, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Subgroup analyses for patients with poorly controlled symptoms (frequent short-acting beta-agonist users; frequent exacerbators) were performed. RESULTS In elderly patients with severe asthma, the incremental cost and effectiveness in the tiotropium group compared with the inhaled corticosteroid and long-acting beta-agonist group were $2281 and 0.038 QALYs, respectively. The incremental cost-effectiveness ratio was $60,074/QALY, indicating that the addition of tiotropium is not a cost-effective alternative. Meanwhile, 2 subgroups with poorly controlled symptoms showed that adding tiotropium is a cost-effective alternative (frequent short-acting beta-agonist users $4078/QALY; frequent exacerbators $8332/QALY). CONCLUSIONS Tiotropium shows a higher cost-effectiveness profile when applied to elderly patients with uncontrolled symptoms. These results using real-world evidence provide information beyond the clinical outcomes reported by randomized controlled trials, providing a complementary ground in establishing the reimbursement criteria of tiotropium for elderly patients with severe asthma.
Collapse
|
43
|
Pham T, Bugeja L, Holmes A, Ibrahim JE. Systematic Review of Randomized Controlled Trials in Australian Nursing Homes from 2000 to 2018. J Am Geriatr Soc 2020; 69:1086-1093. [PMID: 33216941 DOI: 10.1111/jgs.16944] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/30/2020] [Revised: 10/12/2020] [Accepted: 10/24/2020] [Indexed: 11/30/2022]
Abstract
BACKGROUND/OBJECTIVES High-quality research provides an evidence base for optimal practice care in clinical settings, yet, little is known about the nature and extent of randomized control trials (RCTs) conducted in Australian nursing homes (NHs). Research from other settings and other countries is not necessarily transferable to the Australian NH sector. We sought to identify and describe RCTs conducted in Australia which investigated interventions targeted at improving care for NH residents. DESIGN The design of this study comprised a systematic literature search with a narrative review. Studies were included if they were RCTs published after 2000, conducted in an Australian NH, and evaluated a health intervention which may have directly or indirectly benefitted the NH resident. SETTING Australian NHs. PARTICIPANTS Nursing home residents. MEASUREMENTS Jurisdiction (state or territory where the study was conducted), number of NHs recruited in each trial, number of residents included in each trial, intervention characteristics, comparator characteristics, and characteristics of outcome. RESULTS Only 43 articles reporting on 39 RCTs were identified. In contrast, 30 Australian musculoskeletal RCTs were published in just 2 years (2011-2012). Most of the RCTs identified were conducted in New South Wales (n = 14), Queensland (n = 10), and Victoria (n = 9). The mean number of NHs included in each trial was 22.4 (standard deviation (SD) = 27.0), with a median of 14.5 (interquartile range (IQR) = 27.8), while the mean number of residents included was 412.4 (SD = 921) with a median of 187 (IQR = 341.0). The most common interventions targeted: managing dementia (n = 20), prevention of falls (n = 7), and addressing mental health issues (n = 6). CONCLUSION This review provides evidence of the paucity of high-quality research in the form of RCTs, in the Australian NH setting and demonstrates the need for Australia to improve its research capability in the NH sector.
Collapse
Affiliation(s)
- Tony Pham
- Health Law and Ageing Research Unit, Department of Forensic Medicine, Monash University, Melbourne, Victoria, Australia
| | - Lyndal Bugeja
- Health Law and Ageing Research Unit, Department of Forensic Medicine, Monash University, Melbourne, Victoria, Australia
| | - Alice Holmes
- Health Law and Ageing Research Unit, Department of Forensic Medicine, Monash University, Melbourne, Victoria, Australia
| | - Joseph E Ibrahim
- Health Law and Ageing Research Unit, Department of Forensic Medicine, Monash University, Melbourne, Victoria, Australia
| |
Collapse
|
44
|
Public Awareness about Medicine Information, Safety, and Adverse Drug Reaction (ADR) Reporting in Dammam, Saudi Arabia. PHARMACY 2020; 8:pharmacy8040222. [PMID: 33218152 PMCID: PMC7712078 DOI: 10.3390/pharmacy8040222] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2020] [Revised: 10/29/2020] [Accepted: 11/05/2020] [Indexed: 11/23/2022] Open
Abstract
This study aimed to assess public knowledge about medicine information, safety, and adverse drug reaction reporting (ADR) in Dammam, Saudi Arabia. A cross sectional study was conducted using purposive stratified sampling in different settings of Dammam city for three months (January–March 2020). The target population was identified as consumers who had used the medicines in the last 3 months. The questionnaire was adopted from the literature and was validated. Content and face validities were established, and reliability was assessed. The study was approved by the concerned ethics committee. A total of 915 participants returned completed questionnaires. A total of 54.4% participants aged between 18 and 30 years, 65.8% were females and 53.1% had obtained bachelor level education. The mean score for knowledge of medicines (K1) was 5.46 ± 1.07. The mean score for knowledge regarding medication safety (K2) was 5.94 ± 1.73. The mean score for tendency to report a suspected ADR (T1) was 3.43 ± 1.57. Gender was a determinant of knowledge regarding medication safety (K2) (p < 0.01) and ADR reporting tendency (T1) (p < 0.01). The marital status of patients was a determinant for both knowledge of medicines (K1) (p < 0.01) and, knowledge regarding medication safety (K2) (p < 0.01). The results of this study highlighted that although the scores for knowledge of medicines, and tendency to report ADR were better, the score for knowledge regarding medication safety was unsatisfactory.
Collapse
|
45
|
Margaglione M, Antonucci E, D’Andrea G, Migliaccio L, Ageno W, Bucherini E, Cosmi B, Falanga A, Martini G, Mastroiacovo D, Paparo C, Poli D, Testa S, Palareti G. Anticoagulation in Italian patients with venous thromboembolism and thrombophilic alterations: findings from START2 register study. BLOOD TRANSFUSION = TRASFUSIONE DEL SANGUE 2020; 18:486-495. [PMID: 32955425 PMCID: PMC7605886 DOI: 10.2450/2020.0091-20] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Subscribe] [Scholar Register] [Received: 04/13/2020] [Accepted: 05/30/2020] [Indexed: 11/21/2022]
Abstract
BACKGROUND Randomised control trials have assessed the efficacy and safety of direct oral anticoagulants in the prophylaxis and treatment of venous thromboembolism (VTE). Positive but limited results have been reported in patients with inherited thrombophilia. Using an Italian, multicentre, prospective registry of consecutive patients presenting with symptomatic, acute VTE, we aimed to assess which factors are involved in making the choice of the drug that best fits the patient's risk profile in a large real-world setting of VTE patients. MATERIALS AND METHODS We investigated 4,866 VTE patients who took oral anticoagulants in the period between 2012 and April 2018 to prevent a new thromboembolic episode. RESULTS The large majority of patients who underwent thrombophilic screening, regardless of the results obtained, were prescribed direct oral anticoagulants rather than conventional anticoagulant therapy (p<0.001). During anticoagulation, bleeding events occurred more frequently in patients on conventional anticoagulant therapy (4.2%) than in those receiving direct oral anticoagulants (1.8%) and an increase in bleeding events was observed in patients who tested positive at the thrombophilic screening. Overall, a higher number of recurrent VTE was observed in patients not screened for thrombophilia (n=36; 1.7%) than in those screened (n=20; 0.7%; adjusted odds ratio: 2.2; 95% confidence interval: 1.2-4.1). DISCUSSION The present data confirm previous findings from other post-marketing registries and suggest that the choice of oral anticoagulation is strongly driven by patients' characteristics and VTE manifestations. Factors leading to the prescription of thrombophilic screening may identify a patient with a lower risk of VTE recurrence during anticoagulation.
Collapse
Affiliation(s)
- Maurizio Margaglione
- Medical Genetics, Department of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy
| | | | - Giovanna D’Andrea
- Medical Genetics, Department of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy
| | | | - Walter Ageno
- Department of Medicine and Surgery, University of Insubria, Varese, Italy
| | | | - Benilde Cosmi
- Angiology Unit, “Sant’Orsola Malpighi” University Hospital, Bologna, Italy
| | - Anna Falanga
- Thrombosis and Haemostasis Centre, Department of Immunohaematology and Transfusion Medicine, Bergamo, Italy
| | | | | | | | - Daniela Poli
- Centre for Atherothrombotic Diseases, “Careggi” University Hospital, Florence, Italy
| | - Sophie Testa
- Haemostasis and Thrombosis Centre, Hospital of Cremona, Cremona, Italy
| | | |
Collapse
|
46
|
van den Heuvel L, Evers LJW, Meinders MJ, Post B, Stiggelbout AM, Heskes TM, Bloem BR, Krijthe JH. Estimating the Effect of Early Treatment Initiation in Parkinson's Disease Using Observational Data. Mov Disord 2020; 36:407-414. [PMID: 33107639 PMCID: PMC7984449 DOI: 10.1002/mds.28339] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/29/2020] [Revised: 09/19/2020] [Accepted: 09/29/2020] [Indexed: 12/30/2022] Open
Abstract
Background Both patients and physicians may choose to delay initiation of dopamine replacement therapy in Parkinson's disease (PD) for various reasons. We used observational data to estimate the effect of earlier treatment in PD. Observational data offer a valuable source of evidence, complementary to controlled trials. Method We studied the Parkinson's Progression Markers Initiative cohort of patients with de novo PD to estimate the effects of duration of PD treatment during the first 2 years of follow‐up, exploiting natural interindividual variation in the time to start first treatment. We estimated the Movement Disorder Society–Unified Parkinson's Disease Rating Scale (MDS‐UPDRS) Part III (primary outcome) and several functionally relevant outcomes at 2, 3, and 4 years after baseline. To adjust for time‐varying confounding, we used marginal structural models with inverse probability of treatment weighting and the parametric g‐formula. Results We included 302 patients from the Parkinson's Progression Markers Initiative cohort. There was a small improvement in MDS‐UPDRS Part III scores after 2 years of follow‐up for patients who started treatment earlier, and similar, but nonstatistically significant, differences in subsequent years. We found no statistically significant differences in most secondary outcomes, including the presence of motor fluctuations, nonmotor symptoms, MDS‐UPDRS Part II scores, and the Schwab and England Activities of Daily Living Scale. Conclusion Earlier treatment initiation does not lead to worse MDS‐UPDRS motor scores and may offer small improvements. These findings, based on observational data, are in line with earlier findings from clinical trials. Observational data, when combined with appropriate causal methods, are a valuable source of additional evidence to support real‐world clinical decisions. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society
Collapse
Affiliation(s)
- Lieneke van den Heuvel
- Center of Expertise for Parkinson & Movement Disorders, department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands
| | - Luc J W Evers
- Center of Expertise for Parkinson & Movement Disorders, department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands.,Institute for Computing and Information Sciences, Radboud University, Nijmegen, the Netherlands
| | - Marjan J Meinders
- Scientific Center for Quality of Healthcare (IQ Healthcare), Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands
| | - Bart Post
- Center of Expertise for Parkinson & Movement Disorders, department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands
| | - Anne M Stiggelbout
- Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Centre, Leiden, the Netherlands
| | - Tom M Heskes
- Institute for Computing and Information Sciences, Radboud University, Nijmegen, the Netherlands
| | - Bastiaan R Bloem
- Center of Expertise for Parkinson & Movement Disorders, department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands
| | - Jesse H Krijthe
- Institute for Computing and Information Sciences, Radboud University, Nijmegen, the Netherlands.,Department of Intelligent Systems, Delft University of Technology, Delft, the Netherlands
| |
Collapse
|
47
|
Maxwell AM, McMahon C, Huber A, Hawkins E, Reay RE. Addressing the Evidence Gap: Protocol for an Effectiveness Study of Circle of Security Parenting, an Attachment-Based Intervention. Front Glob Womens Health 2020; 1:575752. [PMID: 34816157 PMCID: PMC8594052 DOI: 10.3389/fgwh.2020.575752] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/24/2020] [Accepted: 09/09/2020] [Indexed: 11/13/2022] Open
Abstract
Background: Parenting interventions informed by attachment theory are an increasingly popular choice for clinical services that work with parents of babies and young children. Circle of Security Parenting (COS-P) is one such intervention, which has had extraordinary uptake internationally. Evidence for COS-P is very limited, however; there are few published studies, most with very small samples, and findings are mixed. This paper describes a multi-site evaluation of COS-P, designed to help address this evidence gap. Methods/Design: This is a non-randomized controlled effectiveness study of COS-P in four community child and family health settings. Participants are caregivers of children aged 6 years and under, who present to study sites with parenting challenges in the early parenting period. Participants are recruited through these sites, and allocated to either treatment or waitlist control condition based on their capacity to attend the next available COS-P group. Outcomes (changes in caregiving attitudes and capacities linked to child social and emotional development, and caregiver depression symptoms) are assessed at baseline and post-treatment/waitlist using self-report questionnaires (all participants), and a narrative interview and 5-min parent-child interaction (a sub-sample of participants). Additionally, potential moderators of the intervention (demographic, symptom severity) will be tested. Discussion: This is one of the first controlled evaluations of COS-P, and the first in Australia where COS-P dissemination has been particularly widespread. Results from this study will provide valuable information about the effectiveness of COS-P for caregivers with early parenting challenges, and will increase understanding of what works for whom.
Collapse
Affiliation(s)
- Anne-Marie Maxwell
- Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, NSW, Australia
| | - Catherine McMahon
- Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, NSW, Australia
| | - Anna Huber
- Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, NSW, Australia
| | - Erinn Hawkins
- School of Applied Psychology, Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia
| | - Rebecca Elizabeth Reay
- ANU Medical School, Academic Unit of Psychiatry and Addiction Medicine, Australian National University, Canberra, ACT, Australia
- *Correspondence: Rebecca Elizabeth Reay
| |
Collapse
|
48
|
Bowrin K, Briere JB, Levy P, Toumi M, Millier A. Use of real-world evidence in meta-analyses and cost-effectiveness models. J Med Econ 2020; 23:1053-1060. [PMID: 32657189 DOI: 10.1080/13696998.2020.1792917] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/07/2023]
Abstract
Real-world evidence (RWE) provides external validity, supplementing and enhancing the randomized controlled trial data with valuable information on patient behaviors and outcomes, turning efficacy and safety results into real-world effectiveness and risks, but the use of RWE is associated with challenges. The objectives of this communication were to (1) summarize all guidance on how to conduct an RWE meta-analysis (MA) and how to develop an RWE cost-effectiveness model, (2) to describe our experience, challenges faced and solutions identified, (3) to provide recommendations on how to conduct such analyses. No formal guidelines on how to conduct an RWE MA or to develop an RWE cost-effectiveness model were identified. Using the context of non-vitamin K antagonist oral anticoagulants in stroke prevention in atrial fibrillation, we conducted an RWE MA, after having identified sources of uncertainty. We then implemented the results in an RWE cost-effectiveness model, defined as a model where all inputs come from RWE, including all parameters related to treatment effect. Based on challenges faced, our first recommendation relates to the necessity of conducting sensitivity analyses, either based on clinical or methodological considerations. Our second recommendation is the need for extensive collaboration with a wide range of experts, during the development of the analyses protocols, the implementation of the analyses and the interpretation of the results. RWE may address a number of gaps related to the treatment effect, and RWE economic evaluations for the treatment effect can provide extremely valuable insights into real-world economic value of interventions. As the increased recognition of the value of RWE could influence health technology assessment decision, and current practices, this communication supports the urgent need of more formal guidelines.
Collapse
Affiliation(s)
| | | | - Pierre Levy
- LEDa-LEGOS, Place du Maréchal de Lattre de Tassigny, Université Paris-Dauphine, PSL Research University, Paris, France
| | - Mondher Toumi
- Centre d'étude et de recherche sur les services de santé et la qualité de vie, Aix-Marseille University, Jardin du Pharo, Marseille, France
| | | |
Collapse
|
49
|
Louie CE, D'Agostino E, Woods A, Ryken T. Study Design in Neurosurgical Research: Considerations for Observational and Experimental Cohort Studies. Neurosurgery 2020; 86:14-18. [PMID: 31552423 DOI: 10.1093/neuros/nyz386] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2018] [Accepted: 07/17/2019] [Indexed: 02/01/2023] Open
Abstract
There is inadequate neurosurgical literature discussing appropriate clinical study design. Here, we explore considerations for 2 fundamental study designs of epidemiology: experimental and observational cohort studies, through examples of theoretical yet realistic neurosurgical research questions. By examining 2 common neurosurgical procedures-namely, subdural drains for evacuation of chronic subdural hematoma, and the utility of navigation for placing external ventricular drains-we characterize the framework of cohort study models for clinical research applications.
Collapse
Affiliation(s)
| | - Erin D'Agostino
- Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire
| | - Alexander Woods
- Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire
| | - Timothy Ryken
- Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire.,Section of Neurosurgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
| |
Collapse
|
50
|
Bowrin K, Briere JB, Levy P, Millier A, Tardu J, Toumi M. Real-world cost-effectiveness of rivaroxaban and apixaban vs VKA in stroke prevention in non-valvular atrial fibrillation in the UK. JOURNAL OF MARKET ACCESS & HEALTH POLICY 2020; 8:1782164. [PMID: 32944199 PMCID: PMC7482848 DOI: 10.1080/20016689.2020.1782164] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 02/11/2020] [Revised: 06/08/2020] [Accepted: 06/09/2020] [Indexed: 06/11/2023]
Abstract
BACKGROUND Morbidity and mortality associated with non-valvular atrial fibrillation (NVAF) imposes a substantial economic burden on the UK healthcare system. OBJECTIVES An existing Markov model was adapted to assess the real-world cost-effectiveness of rivaroxaban and apixaban, each compared with a vitamin K antagonist (VKA), for stroke prevention in patients with NVAF from the National Health Service (NHS) and personal and social services (PSS) perspective. METHODS The model considered a cycle length of 3 months over a lifetime horizon. All inputs were drawn from real-world evidence (RWE): baseline patient characteristics, clinical event and persistence rates, treatment effect (meta-analysis of RWE studies), utility values and resource use. Deterministic and probabilistic sensitivity analyses were performed. RESULTS The incremental cost per quality-adjusted life year was £14,437 for rivaroxaban, and £20,101 for apixaban, compared with VKA. The probabilities to be cost-effective compared with VKA were 90% and 81%, respectively for rivaroxaban and apixaban, considering a £20,000 threshold. In both comparisons, the results were most sensitive to clinical event rates. CONCLUSIONS These results suggest that rivaroxaban and apixaban are cost-effective vs VKA, based on RWE, considering a £20,000 threshold, from the NHS and PSS perspective in the UK for stroke prevention in patients with NVAF. This economic evaluation may provide valuable information for decision-makers, in a context where RWE is more accessible and its value more acknowledged.
Collapse
Affiliation(s)
| | | | - Pierre Levy
- Université Paris-Dauphine, PSL Research University, LEDa-LEGOS, Paris, France
| | | | | | | |
Collapse
|