Defining feasibility and pilot studies in preparation for randomised controlled trials: development of a conceptual framework.

PLoS One. 11e0150205

CONSORT 2010 statement: extension to randomised pilot and feasibility trials.

BMJ. : 355

A pragmatic view on pragmatic trials.

Dialogues Clin Neurosci. 13: 217-224

Explanatory and pragmatic attitudes in therapeutical trials.

J Chronic Dis. 20: 637-648

Understanding controlled trials: What are pragmatic trials?.

BMJ. 316: 285Treweek S. Zwarenstein M.

Making trials matter: pragmatic and explanatory trials and the problem of applicability.

Trials. 10: 37

A tutorial on pilot studies: the what, why and how.

BMC Medical Research Methodology. 10: 1

The design and interpretation of pilot trials in clinical research in critical care.

Critical care medicine. 37: S69-S74

What is a pilot or feasibility study? A review of current practice and editorial policy.

BMC Medical Research Methodology. 10: 67Lancaster GA Dodd S Williamson PR.

Design and analysis of pilot studies: recommendations for good practice.

J Eval Clin Pract. 10 (): 307-312https://doi.org/10.1111/j..2002.384.doc.x

The PRECIS-2 tool: designing trials that are fit for purpose.

BMJ : British Medical Journal. : 350Nicholls S.G. Carroll K. Zwarenstein M. et al.

The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders.

Trials. 20: 765https://doi.org/10.1186/s13063-019-3899-xHung A. B.C. Bekelman J. Fitz-Randolph M. Daniel Mullins C.

Patient and Stakeholder Engagement in Designing Pragmatic Clinical Trials.

in: Birnbaum H. Greenberg P. Decision Making in a World of Comparative Effectiveness Research. Adis, SingaporeKeith R.E. Crosson J.C. O'Malley A.S et al.

Using the Consolidated Framework for Implementation Research (CFIR) to produce actionable findings: a rapid-cycle evaluation approach to improving implementation.

Implementation Sci. 12: 15Atkins L. Francis J. Islam R. et al.

A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems.

Implementation Sci. 12: 77https://doi.org/10.1186/s13012-017-0605-9

A mixed methods study to evaluate the feasibility of using the Adolescent Diabetes Needs Assessment Tool App in paediatric diabetes care in preparation for a longitudinal cohort study.

Pilot and Feasibility Studies. 4: 13

Design and baseline data from a PCORI-funded randomized controlled trial of family-centered tailoring of diabetes self-management resources.

Contemp Clin Trials. 58: 58-65

Use of altered informed consent in pragmatic clinical research.

Clinical Trials. 12: 494-502Hemming K Haines T.P. Chilton P.J. Girling A.J. Lilford R.J.

The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting.

BMJ. 350: h391https://doi.org/10.1136/bmj.h391Hemming K Taljaard M Weijer C Forbes AB.

Use of multiple period, cluster randomised, crossover trial designs for comparative effectiveness research.

BMJ. 371: m3800

FLUID trial: a protocol for a hospital-wide open-label cluster crossover pragmatic comparative effectiveness randomised pilot trial.

BMJ Open. 8e022780

Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes.

BMC Cancer. 14: 55Treweek S. Banister K. Bower P. et al.

Developing the INCLUDE Ethnicity Framework—a tool to help trialists design trials that better reflect the communities they serve.

Trials. 22: 337https://doi.org/10.1186/s13063-021-05276-8Brehaut JC Carroll K Presseau J Richards DP Gordon J Bénard A Hudek N Graham ID Fergusson DA Marlin S

A patient-focused, theory-guided approach to survey design identified barriers to and drivers of clinical trial participation.

J Clin Epidemiol. 132 (): 106-115https://doi.org/10.1016/j.jclinepi.2020.12.013

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

Medicine & Science in Sports & Exercise. 49: 2506-2516

DIAMOND (DIgital Alcohol Management ON Demand): a mixed methods feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use.

Pilot and Feasibility Studies. 3: 34

A randomised controlled feasibility trial and qualitative evaluation of an early years language development intervention: study protocol of the ‘outcomes of Talking Together evaluation and results’ (oTTer) project.

Pilot and Feasibility Studies. 5: 119Hemming Karla Taljaard Monica

Reflection on modern methods: when is a stepped-wedge cluster randomized trial a good study design choice?.

International Journal of Epidemiology. 49 (): 1043-1052

Maximising recruitment and retention of general practices in clinical trials: a case study.

Br J Gen Pract. 58: 759-766

Feasibility Randomised trial comparing two forms of mental health supported accommodation (supported housing and floating outreach); a component of the QuEST (Quality and Effectiveness of Supported Tenancies) study.

Frontiers in psychiatry. : 10

Learnings from a pragmatic pilot trial of text messaging for high risk adolescents with asthma.

Ann Allergy Asthma Immunol.

Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes.

BMC Cancer. 14: 55Dember LM Lacson E Brunelli SM Hsu JY Cheung AK Daugirdas JT Greene T Kovesdy CP Miskulin DC Thadhani RI Winkelmayer WC Ellenberg SS Cifelli D Madigan R Young A Angeletti M Wingard RL Kahn C Nissenson AR Maddux FW Abbott KC Landis JR. JASN. 30 (): 890-903https://doi.org/10.1681/ASN.2018090945

Routinely collected data for randomized trials: promises, barriers, and implications.

Trials. 19: 29

Hip fracture in the elderly multidisciplinary rehabilitation (FEMuR) feasibility study: testing the use of routinely collected data for future health economic evaluations.

Pilot and Feasibility Studies. 4: 76

Feder, G., et al. Prevention of domestic violence (PreDoVe). 2005 [cited 2019 22 Jan]; Available from: http://webspace.qmul.ac.uk/spriebe/publications/pub%20by%20year/2005/2005%20-%20Preventon%20of%20domestic%20violence%20(PreDoVe)%20-%20Report%20to%20the%20Nuffield%20Foundation.pdf

The Patient Reported Outcomes, Burdens and Experiences (PROBE) Project: development and evaluation of a questionnaire assessing patient reported outcomes in people with haemophilia.

Pilot and Feasibility Studies. 4: 58Taljaard M. Weijer C. Grimshaw J.M. et al.

Developing a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol.

Trials. 19: 525https://doi.org/10.1186/s13063-018-2895-xDal-Ré R Avendaño-Solà C Bloechl-Daum B de Boer A Eriksson S Fuhr U et al.

Low risk pragmatic trials do not always require participants’ informed consent.

BMJ. 364: l1092

Informed consent for pragmatic trials–the integrated consent model.

N Engl J Med. 370 (): 769-772https://doi.org/10.1056/NEJMhle1312508

Refusal rates and waivers of informed consent in pragmatic and comparative effectiveness RCTs: A systematic review.

Contemp Clin Trials. 104 ()106361https://doi.org/10.1016/j.cct.2021.106361

Zhang JZ, Nicholls SG, Carroll K, Nix HP, Goldstein CE, Hey SP, Brehaut JC, McLean PC, Weijer C, Fergusson DA, Taljaard M. Informed consent in pragmatic trials: Results from a survey of trials published 2014-2019”. Under review.

Eldridge S Kerry S Torgerson DJ.

Bias in identifying and recruiting participants in cluster randomised trials: what can be done?.

BMJ. 339 (): b4006https://doi.org/10.1136/bmj.b4006Baier R.R. Jutkowitz E. Mitchell S.L. et al.

Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial.

BMC Med Res Methodol. 19: 156

A mixed methods study to evaluate the feasibility of using the Adolescent Diabetes Needs Assessment Tool App in paediatric diabetes care in preparation for a longitudinal cohort study.

Pilot and Feasibility Studies. 4: 13

Design and baseline data from a PCORI-funded randomized controlled trial of family-centered tailoring of diabetes self-management resources.

Contemp Clin Trials. 58: 58-65

FLUID trial: a protocol for a hospital-wide open-label cluster crossover pragmatic comparative effectiveness randomised pilot trial.

BMJ Open. 8e022780

Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes.

BMC Cancer. 14: 55

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

Medicine & Science in Sports & Exercise. 49: 2506-2516

DIAMOND (DIgital Alcohol Management ON Demand): a mixed methods feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use.

Pilot and Feasibility Studies. 3: 34

A randomised controlled feasibility trial and qualitative evaluation of an early years language development intervention: study protocol of the ‘outcomes of Talking Together evaluation and results’ (oTTer) project.

Pilot and Feasibility Studies. 5: 119

Maximising recruitment and retention of general practices in clinical trials: a case study.

Br J Gen Pract. 58: 759-766

Feasibility Randomised trial comparing two forms of mental health supported accommodation (supported housing and floating outreach); a component of the QuEST (Quality and Effectiveness of Supported Tenancies) study.

Frontiers in psychiatry. : 10

Learnings from a pragmatic pilot trial of text messaging for high risk adolescents with asthma.

Ann Allergy Asthma Immunol. Dember LM Lacson E Brunelli SM Hsu JY Cheung AK Daugirdas JT Greene T Kovesdy CP Miskulin DC Thadhani RI Winkelmayer WC Ellenberg SS Cifelli D Madigan R Young A Angeletti M Wingard RL Kahn C Nissenson AR Maddux FW Abbott KC Landis JR. JASN. 30 (): 890-903https://doi.org/10.1681/ASN.2018090945

Hip fracture in the elderly multidisciplinary rehabilitation (FEMuR) feasibility study: testing the use of routinely collected data for future health economic evaluations.

Pilot and Feasibility Studies. 4: 76

Feder, G., et al. Prevention of domestic violence (PreDoVe). 2005 [cited 2019 22 Jan]; Available from: http://webspace.qmul.ac.uk/spriebe/publications/pub%20by%20year/2005/2005%20-%20Preventon%20of%20domestic%20violence%20(PreDoVe)%20-%20Report%20to%20the%20Nuffield%20Foundation.pdf.

The Patient Reported Outcomes, Burdens and Experiences (PROBE) Project: development and evaluation of a questionnaire assessing patient reported outcomes in people with haemophilia.

Pilot and Feasibility Studies. 4: 58