Wolfenden L, Foy R, Presseau J, Grimshaw JM, Ivers NM, Powell BJ, Taljaard M, Wiggers J, Sutherland R, Nathan N, et al. Designing and undertaking randomised implementation trials: guide for researchers. BMJ. 2021;372:m3721.

Article  PubMed  PubMed Central  Google Scholar 

Herrett E, Williamson E, van Staa T, Ranopa M, Free C, Chadborn T, Goldacre B, Smeeth L. Text messaging reminders for influenza vaccine in primary care: a cluster randomised controlled trial (TXT4FLUJAB). BMJ Open. 2016;6:e010069.

Article  PubMed  PubMed Central  Google Scholar 

Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015;10:21.

Article  PubMed  PubMed Central  Google Scholar 

Waltz TJ, Powell BJ, Matthieu MM, Damschroder LJ, Chinman MJ, Smith JL, Proctor EK, Kirchner JE. Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study. Implement Sci. 2015;10:109.

Article  PubMed  PubMed Central  Google Scholar 

Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38:65–76.

Article  PubMed  Google Scholar 

Peremans L, Rethans JJ, Verhoeven V, Coenen S, Debaene L, Meulemans H, Denekens J, Van Royen P. Empowering patients or general practitioners? A randomised clinical trial to improve quality in reproductive health care in Belgium. Eur J Contracept Reprod Health Care. 2010;15:280–9.

Article  PubMed  Google Scholar 

Drake C, Meade C, Hull SK, Price A, Snyderman R. Integration of personalized health planning and shared medical appointments for patients with type 2 diabetes mellitus. South Med J. 2018;111:674–82.

Article  PubMed  Google Scholar 

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50:217–26.

Article  PubMed  PubMed Central  Google Scholar 

Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, Sorensen HT, von Elm E, Langan SM, Committee RW. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med. 2015;12:e1001885.

Article  PubMed  PubMed Central  Google Scholar 

Kwakkenbos L, Imran M, McCall SJ, McCord KA, Frobert O, Hemkens LG, Zwarenstein M, Relton C, Rice DB, Langan SM, et al. CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ. 2021;373:n857.

Article  PubMed  PubMed Central  Google Scholar 

Mc Cord KA, Al-Shahi Salman R, Treweek S, Gardner H, Strech D, Whiteley W, Ioannidis JPA, Hemkens LG. Routinely collected data for randomized trials: promises, barriers, and implications. Trials. 2018;19:29.

Article  PubMed  PubMed Central  Google Scholar 

Fitzpatrick T, Perrier L, Shakik S, Cairncross Z, Tricco AC, Lix L, Zwarenstein M, Rosella L, Henry D. Assessment of long-term follow-up of randomized trial participants by linkage to routinely collected data: a scoping review and analysis. JAMA Netw Open. 2018;1:e186019.

Article  PubMed  PubMed Central  Google Scholar 

Reeves M, Winkler E, McCarthy N, Lawler S, Terranova C, Hayes S, Janda M, Demark-Wahnefried W, Eakin E. The Living Well after Breast Cancer Pilot Trial: a weight loss intervention for women following treatment for breast cancer. Asia Pac J Clin Oncol. 2017;13:125–36.

Article  PubMed  Google Scholar 

Sandner M, Cornelissen T, Jungmann T, Herrmann P. Evaluating the effects of a targeted home visiting program on maternal and child health outcomes. J Health Econ. 2018;58:269–83.

Article  PubMed  Google Scholar 

Downing NL, Rolnick J, Poole SF, Hall E, Wessels AJ, Heidenreich P, Shieh L. Electronic health record-based clinical decision support alert for severe sepsis: a randomised evaluation. BMJ Qual Saf. 2019;28:762–8.

Article  PubMed  PubMed Central  Google Scholar 

McCall SJ, Imran M, Hemkens LG, Mc Cord K, Kwakkenbos L, Sampson M, Jawad S, Zwarenstein M, Relton C, Langan SM, et al. Reporting transparency and completeness in trials: paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records - room for improvement. J Clin Epidemiol. 2022;141:198–209.

Article  PubMed  PubMed Central  Google Scholar 

Imran M, Mc Cord K, McCall SJ, Kwakkenbos L, Sampson M, Frobert O, Gale C, Hemkens LG, Langan SM, Moher D, et al. Reporting transparency and completeness in trials: paper 3 - trials conducted using administrative databases do not adequately report elements related to use of databases. J Clin Epidemiol. 2022;141:187–97.

Article  PubMed  Google Scholar 

Mc Cord KA, Imran M, Rice DB, McCall SJ, Kwakkenbos L, Sampson M, Frobert O, Gale C, Langan SM, Moher D, et al. Reporting transparency and completeness in trials: paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results. J Clin Epidemiol. 2022;141:175–86.

Article  PubMed  Google Scholar 

Hemkens LG, Juszczak E, Thombs BD. Reporting transparency and completeness in trials: paper 1: introduction - better reporting for disruptive clinical trials using routinely collected data. J Clin Epidemiol. 2022;141:172–4.

Article  PubMed  Google Scholar 

Cochrane methodology reviews [https://methodology.cochrane.org/].

Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.

Article  PubMed  PubMed Central  Google Scholar 

Gillum RF. From papyrus to the electronic tablet: a brief history of the clinical medical record with lessons for the digital age. Am J Med. 2013;126:853–7.

Liu FF, Lew A, Andes E, McNamara S, Cassidy J, Whitmore S, Plunkett R, Ong T. Implementation strategies for depression and anxiety screening in a pediatric cystic fibrosis center: a quality improvement project. Pediatr Pulmonol. 2020;55:3328–36.

Article  PubMed  Google Scholar 

Sales A, Smith J, Curran G, Kochevar L, Models, strategies, and tools. Theory in implementing evidence-based findings into health care practice. J Gen Intern Med. 2006;21(Suppl 2):43–9.

Google Scholar 

Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015;10:53.

Article  PubMed  PubMed Central  Google Scholar 

Barr JK, Franks AL, Lee NC, Antonucci DM, Rifkind S, Schachter M. A randomized intervention to improve ongoing participation in mammography. Am J Manag Care. 2001;7:887–94.

CAS  PubMed  Google Scholar 

Cully JA, Armento ME, Mott J, Nadorff MR, Naik AD, Stanley MA, Sorocco KH, Kunik ME, Petersen NJ, Kauth MR. Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design. Implement Sci. 2012;7:64.

Article  PubMed  PubMed Central  Google Scholar 

Spoelstra SL, Schueller M, Sikorskii A. Testing an implementation strategy bundle on adoption and sustainability of evidence to optimize physical function in community-dwelling disabled and older adults in a Medicaid waiver: a multi-site pragmatic hybrid type III protocol. Implement Sci. 2019;14:60.

Article  PubMed  PubMed Central  Google Scholar 

Rosa C, Marsch LA, Winstanley EL, Brunner M, Campbell ANC. Using digital technologies in clinical trials: Current and future applications. Contemp Clin Trials. 2021;100:106219.

Article  PubMed  Google Scholar 

Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, Rycroft-Malone J, Meissner P, Murray E, Patel A, et al. Standards for Reporting Implementation Studies (StaRI) statement. BMJ. 2017;356:i6795.

Article  PubMed  PubMed Central  Google Scholar 

Hsu A, Luo J, Rowe J, Dennis J, Smyth S. Towards data-driven clinical trial planning and strategy. Appl Clin Trials. 2022;31(1/2):21–5.

Sydes MR, Barbachano Y, Bowman L, Denwood T, Farmer A, Garfield-Birkbeck S, Gibson M, Gulliford MC, Harrison DA, Hewitt C, et al. Realising the full potential of data-enabled trials in the UK: a call for action. BMJ Open. 2021;11:e043906.

Article  PubMed  PubMed Central  Google Scholar 

Quint JK, Moore E, Lewis A, Hashmi M, Sultana K, Wright M, Smeeth L, Chatzidiakou L, Jones R, Beevers S, et al. Recruitment of patients with chronic obstructive pulmonary disease (COPD) from the Clinical Practice Research Datalink (CPRD) for research. NPJ Prim Care Respir Med. 2018;28:21.

Article  PubMed  PubMed Central  Google Scholar 

Cake C, Ogburn E, Pinches H, Coleman G, Seymour D, Woodard F, Manohar S, Monsur M, Landray M, Dalton G, et al. Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments. Trials. 2022;23:62.

Article  CAS  PubMed  PubMed Central  Google Scholar 

McKay AJ, Jones AP, Gamble CL, Farmer AJ, Williamson PR. Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials. F1000Res. 2020;9:323.

Article  PubMed  Google Scholar 

Rosa C, Campbell AN, Miele GM, Brunner M, Winstanley EL. Using e-technologies in clinical trials. Contemp Clin Trials. 2015;45:41–54.

Article  PubMed  PubMed Central  Google Scholar 

Two years on from RECOVERY: paving the way to a data-enabled future for clinical trials [hdruk.ac.uk/news/two-years-on-from-recovery-paving-the-way-to-a-data-enabled-future-for-clinical-trials/].

Staa TP, Goldacre B, Gulliford M, Cassell J, Pirmohamed M, Taweel A, Delaney B, Smeeth L. Pragmatic randomised trials using routine electronic health records: putting them to the test. BMJ. 2012;344:e55.

Article  PubMed  PubMed Central  Google Scholar 

McGregor J, Brooks C, Chalasani P,