TY - JOUR
T1 - Population characteristics as important contextual factors in rheumatological trials
T2 - an exploratory meta-epidemiological study from an OMERACT Working Group
AU - Nielsen, Sabrina Mai
AU - Storgaard, Helene
AU - Ellingsen, Torkell
AU - Shea, Beverley J.
AU - Wells, George A.
AU - Welch, Vivian Andrea
AU - Furst, Daniel E.
AU - de Wit, Maarten
AU - Voshaar, Marieke
AU - Juhl, Carsten Bogh
AU - Boers, Maarten
AU - Escorpizo, Reuben
AU - Woodworth, Thasia G.
AU - Boonen, Annelies
AU - Bliddal, Henning
AU - March, Lyn M.
AU - Tugwell, Peter
AU - Christensen, Robin
N1 - Funding Information:
Funding The parker institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The parker institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the oak Foundation (ocaY-18-774-oFil). The oak Foundation is a group of philanthropic organisations that, since its establishment in 1983, has given grants to not-for-profit organisations around the world. smn has received phd scholarships from the Faculty of Health sciences, University of southern denmark and odense University Hospital, and an introductory scholarship from the BFH Research Foundation. The funders had no role in the study design, data collection, data analysis, data interpretation or writing of the report. The corresponding author had full access to all data of the study and had final responsibility for the decision to submit for publication.
Publisher Copyright:
©
PY - 2020/10
Y1 - 2020/10
N2 - Objectives To explore whether trial population characteristics modify treatment responses across various interventions, comparators and rheumatic conditions. Methods In this meta-epidemiological study, we included trials from systematic reviews available from the Cochrane Musculoskeletal Group published up to 23 April 2019 in Cochrane Library with meta-analyses of five or more randomised controlled trials (RCTs) published from year 2000. From trial reports, we extracted data on 20 population characteristics. For characteristics with sufficient data (ie, available for >= 2/3 of the trials), we performed multilevel meta-epidemiological analyses. Results We identified 19 eligible systematic reviews contributing 187 RCTs (212 comparisons). Only age and sex were explicitly reported in >= 2/3 of the trials. Using information about the country of the trials led to sufficient data for five further characteristics, that is, 7 out of 20 (35%) protocolised characteristics were analysed. The meta-regressions showed effect modification by economic status, place of residence, and, nearly, from healthcare system (explaining 4.8%, 0.9% and 1.5% of the between-trial variation, respectively). No effect modification was demonstrated from age, sex, patient education/health literacy or predominant religion. Conclusions This study demonstrates the scarce reporting of most population characteristics, hampering investigation of their impact with meta-research. Our sparse results suggest that place of residence (ie, continent of the trial), economic status (based on World Bank classifications) and healthcare system (based on WHO index for health system performance) may be important in explaining the variation in treatment response across trials. There is an urgent need for consistent reporting of important population characteristics in trials. PROSPERO registration number CRD42019127642
AB - Objectives To explore whether trial population characteristics modify treatment responses across various interventions, comparators and rheumatic conditions. Methods In this meta-epidemiological study, we included trials from systematic reviews available from the Cochrane Musculoskeletal Group published up to 23 April 2019 in Cochrane Library with meta-analyses of five or more randomised controlled trials (RCTs) published from year 2000. From trial reports, we extracted data on 20 population characteristics. For characteristics with sufficient data (ie, available for >= 2/3 of the trials), we performed multilevel meta-epidemiological analyses. Results We identified 19 eligible systematic reviews contributing 187 RCTs (212 comparisons). Only age and sex were explicitly reported in >= 2/3 of the trials. Using information about the country of the trials led to sufficient data for five further characteristics, that is, 7 out of 20 (35%) protocolised characteristics were analysed. The meta-regressions showed effect modification by economic status, place of residence, and, nearly, from healthcare system (explaining 4.8%, 0.9% and 1.5% of the between-trial variation, respectively). No effect modification was demonstrated from age, sex, patient education/health literacy or predominant religion. Conclusions This study demonstrates the scarce reporting of most population characteristics, hampering investigation of their impact with meta-research. Our sparse results suggest that place of residence (ie, continent of the trial), economic status (based on World Bank classifications) and healthcare system (based on WHO index for health system performance) may be important in explaining the variation in treatment response across trials. There is an urgent need for consistent reporting of important population characteristics in trials. PROSPERO registration number CRD42019127642
KW - arthritis
KW - epidemiology
KW - outcomes research
KW - CLINICAL-TRIALS
KW - OSTEOARTHRITIS TRIALS
KW - SYSTEMATIC REVIEWS
KW - QUALITY
KW - EQUITY
KW - RISK
KW - BIAS
KW - INTERVENTIONS
U2 - 10.1136/annrheumdis-2020-217237
DO - 10.1136/annrheumdis-2020-217237
M3 - Article
C2 - 32606042
SN - 0003-4967
VL - 79
SP - 1269
EP - 1276
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 10
ER -