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Registry randomised trials: a methodological perspective.
Doherty, Dorota A; Tong, Steven Y C; Reilly, Jennifer; Shrapnel, Jane; McDonald, Stephen; Ahern, Susannah; Harris, Ian; Tam, Charmaine S; Brennan, Angela L; Hodgson, Carol; Wilcox, Leonie; Balagurunathan, Anitha; Butcher, Belinda E; Reid, Christopher M.
Affiliation
  • Doherty DA; UWA Medical School, The University of Western Australia, Perth, Western Australia, Australia.
  • Tong SYC; Biostatistics and Research Design Unit, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia.
  • Reilly J; The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
  • Shrapnel J; Menzies School of Health Research, Casuarina, Nothern Territory, Australia.
  • McDonald S; Anaesthesiology & Perioperative Medicine, Alfred Hospital, Melbourne, Victoria, Australia.
  • Ahern S; Department of Anaesthesia and Perioperative Medicine, Monash University, Melbourne, Victoria, Australia.
  • Harris I; The Sydney Children's Hospitals Network, Westmead, New South Wales, Australia.
  • Tam CS; Central Northern Adelaide Dialysis, The University of Adelaide, Adelaide, South Australia, Australia.
  • Brennan AL; Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute Limited, Adelaide, South Australia, Australia.
  • Hodgson C; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
  • Wilcox L; Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW, Sydney, New South Wales, Australia.
  • Balagurunathan A; Northern Clinical School, Centre for Translational Data Science, The University of Sydney, Sydney, New South Wales, Australia.
  • Butcher BE; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
  • Reid CM; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
BMJ Open ; 13(3): e068057, 2023 03 01.
Article in En | MEDLINE | ID: mdl-36858472
ABSTRACT
Registry randomised clinical trials (RRCTs) have the potential to provide pragmatic answers to important clinical questions. RRCTs can be embedded into large population-based registries or smaller single site registries to provide timely answers at a reduced cost compared with traditional randomised controlled trials. RRCTs can take a number of forms in addition to the traditional individual-level randomised trial, including parallel group trials, platform or adaptive trials, cluster randomised trials and cluster randomised stepped-wedge trials. From an implementation perspective, initially it is advantageous to embed RRCT into well-established registries as these have typically already overcome any issues with end point validation and adjudication. With advances in data linkage and data quality, RRCTs can play an important role in answering clinical questions in a pragmatic, cost-effective way.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Randomized Controlled Trials as Topic / Registries / Data Accuracy Type of study: Clinical_trials Limits: Humans Language: En Journal: BMJ Open Year: 2023 Document type: Article Affiliation country: Australia
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Randomized Controlled Trials as Topic / Registries / Data Accuracy Type of study: Clinical_trials Limits: Humans Language: En Journal: BMJ Open Year: 2023 Document type: Article Affiliation country: Australia