CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Sandra M Eldridge, Claire L Chan, Michael J Campbell, Christine M Bond, Sally Hopewell, Lehana Thabane, Gillian A Lancaster, PAFS consensus group, Sandra M Eldridge, Claire L Chan, Michael J Campbell, Christine M Bond, Sally Hopewell, Lehana Thabane, Gillian A Lancaster, PAFS consensus group

Abstract

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply.

The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist.

The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number.

This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials.

Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.

Conflict of interest statement

All authors have completed the ICMJE disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare support from the following organisations for the submitted work—Queen Mary University of London, University of Sheffield (ScHARR Research Committee Pump priming grant), NIHR Research Design Services London and South East, NIHR Statisticians Group, Chief Scientist Office Scotland. GAL is editor in chief of the new BioMed central journal Pilot and Feasibility Studies proposed by Daniel R Shanahan, which was created out of this work. Daniel R Shanahan is employed by BioMed Central, and Trish Groves is an editor of the BMJ. SME, CMB, MJC, and LT are on the editorial board of Pilot and Feasibility Studies and CLC is an associate editor. Frank Bretz works for Novartis. The authors declare no other competing interests. None of the listed people involved in either journal played any part in the peer review process or editorial decision making.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/5076380/bin/elds033598.f1_default.jpg
Fig 1 Example of abstract for report of pilot trial, shown alongside CONSORT for abstracts extension for pilot randomised trials
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/5076380/bin/elds033598.f2_default.jpg
Fig 2 Revised version of example abstract for report of pilot trial, shown alongside CONSORT for abstracts extension for pilot randomised trials
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/5076380/bin/elds033598.f3_default.jpg
Fig 3 Track changes version of example abstract for report of pilot trial, showing changes between figures 1 and 2
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/5076380/bin/elds033598.f4_default.jpg
Fig 4 Flow diagram of a randomised pilot trial of pharmacist led management of chronic pain in primary care (reproduced from Bruhn et al69)
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/5076380/bin/elds033598.f5_default.jpg
Fig 5 Recommended flow diagram of progress through phases of a parallel randomised pilot trial of two groups—that is, screening, enrolment, intervention allocation, follow-up, and assessment for each pilot trial objective. Adapted from Moher et al

References

    1. Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010;152:726-32. 10.7326/0003-4819-152-11-201006010-00232 .
    1. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869 10.1136/bmj.c869 .
    1. Turner L, Moher D, Shamseer L, et al. The influence of CONSORT on the quality of reporting of randomised controlled trials: an updated review. Trials 2011;12(Suppl 1):A47.10.1186/1745-6215-12-S1-A47.
    1. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006;295:1152-60. 10.1001/jama.295.10.1152 .
    1. Campbell MK, Piaggio G, Elbourne DR, Altman DG. CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661 10.1136/bmj.e5661 .
    1. Zwarenstein M, Treweek S, Gagnier JJ, et al. CONSORT group Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390 10.1136/bmj.a2390 .
    1. Ioannidis JP, Evans SJ, Gøtzsche PC, et al. CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8. 10.7326/0003-4819-141-10-200411160-00009 .
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148:295-309. 10.7326/0003-4819-148-4-200802190-00008 .
    1. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. CONSORT Group. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006;144:364-7. 10.7326/0003-4819-144-5-200603070-00013 .
    1. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD. CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 2013;309:814-22. 10.1001/jama.2013.879 .
    1. Eldridge SM, Lancaster GA, Campbell MJ, et al. Defining feasibility and pilot studies in preparation for randomised controlled trials: development of a conceptual framework. PLoS One 2016;11:e0150205 10.1371/journal.pone.0150205 .
    1. Shanyinde M, Pickering RM, Weatherall M. Questions asked and answered in pilot and feasibility randomized controlled trials. BMC Med Res Methodol 2011;11:117 10.1186/1471-2288-11-117 .
    1. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract 2004;10:307-12. 10.1111/j..2002.384.doc.x .
    1. Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol 2010;10:1 10.1186/1471-2288-10-1 .
    1. Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol 2010;10:67 10.1186/1471-2288-10-67 .
    1. Cartwright ME, Cohen S, Fleishaker JC, et al. Proof of concept: a PhRMA position paper with recommendations for best practice. Clin Pharmacol Ther 2010;87:278-85. 10.1038/clpt.2009.286 .
    1. Fisch R, Jones I, Jones J, Kerman J, Rosenkranz GK, Schmidli H. Bayesian design of proof-of-concept trials. Ther Innov Regul Sci 2015;49:155-6210.1177/2168479014533970.
    1. Stallard N. Optimal sample sizes for phase II clinical trials and pilot studies. Stat Med 2012;31:1031-42. 10.1002/sim.4357 .
    1. Burke DL, Billingham LJ, Girling AJ, Riley RD. Meta-analysis of randomized phase II trials to inform subsequent phase III decisions. Trials 2014;15:346 10.1186/1745-6215-15-346 .
    1. Talmor D, Sarge T, Malhotra A, et al. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med 2008;359:2095-104. 10.1056/NEJMoa0708638 .
    1. Ashe MC, Winters M, Hoppmann CA, et al. “Not just another walking program”: Everyday Activity Supports You (EASY) model-a randomized pilot study for a parallel randomized controlled trial. Pilot Feasibility Stud 2015;1:1-12. 10.1186/2055-5784-1-4 .
    1. Hoddinott P, Craig L, Maclennan G, Boyers D, Vale L. NHS Grampian and the University of Aberdeen FEST project team. Process evaluation for the FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas. BMJ Open 2012;2:e001039 10.1136/bmjopen-2012-001039 .
    1. Schoultz M, Macaden L, Hubbard G. Participants’ perspectives on mindfulness-based cognitive therapy for inflammatory bowel disease: a qualitative study nested within a pilot randomised controlled trial. Pilot Feasibility Stud 2016;2:3.10.1186/s40814-015-0041-z.
    1. O’Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med 2014;89:1245-51. 10.1097/ACM.0000000000000388 .
    1. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007;19:349-57. 10.1093/intqhc/mzm042 .
    1. O’Cathain A, Hoddinott P, Lewin S, et al. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasibility Stud 2015;1:32.10.1186/s40814-015-0026-y.
    1. Stansfeld SA, Kerry S, Chandola T, et al. Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study. BMJ Open 2015;5:e007981 10.1136/bmjopen-2015-007981 .
    1. O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. BMJ Open 2013;3:e002889 10.1136/bmjopen-2013-002889 .
    1. Hoddinott P, Craig L, Maclennan G, Boyers D, Vale L. NHS Grampian and the University of Aberdeen FEST Project Team. The FEeding Support Team (FEST) randomised, controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas. BMJ Open 2012;2:e000652 10.1136/bmjopen-2011-000652 .
    1. Thabane L, Hopewell S, Lancaster GA, et al. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud 2016;2:25.10.1186/s40814-016-0065-z
    1. Gilbody S, Peckham E, Man M-S, et al. Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial. Lancet Psychiatry 2015;2:395-402. 10.1016/S2215-0366(15)00091-7 .
    1. Stow R, Ives N, Smith C, Rick C, Rushton A. A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents. Trials 2015;16:433 10.1186/s13063-015-0952-2 .
    1. Dickersin K, Manheimer E, Wieland S, Robinson KA, Lefebvre C, McDonald S. Development of the Cochrane Collaboration’s CENTRAL Register of controlled clinical trials. Eval Health Prof 2002;25:38-64. 10.1177/0163278702025001004 .
    1. Leblanc A, Légaré F, Labrecque M, et al. Feasibility of a randomised trial of a continuing medical education program in shared decision-making on the use of antibiotics for acute respiratory infections in primary care: the DECISION+ pilot trial. Implement Sci 2011;6:5 10.1186/1748-5908-6-5 .
    1. Hopewell S, Clarke M, Moher D, et al. CONSORT Group. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet 2008;371:281-3. 10.1016/S0140-6736(07)61835-2 .
    1. Hopewell S, Clarke M, Moher D, et al. CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med 2008;5:e20 10.1371/journal.pmed.0050020 .
    1. Heazell AE, Bernatavicius G, Roberts SA, et al. A randomised controlled trial comparing standard or intensive management of reduced fetal movements after 36 weeks gestation--a feasibility study. BMC Pregnancy Childbirth 2013;13:95 10.1186/1471-2393-13-95 .
    1. World Medical Association declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997;277:925-6. 10.1001/jama.1997.03540350075038 .
    1. Hill KM, Walwyn RE, Camidge DC, et al. Lifestyle referral assessment in an acute cardiology setting: study protocol for a randomized controlled feasibility trial. Trials 2013;14:212 10.1186/1745-6215-14-212 .
    1. Hill K, Walwyn R, Camidge D, et al. A randomized feasibility trial of a new lifestyle referral assessment versus usual assessment in an acute cardiology setting. J Cardiovasc Nurs 2015. 10.1097/JCN.0000000000000294 .
    1. Eldridge SM, Costelloe CE, Kahan BC, Lancaster GA, Kerry SM. How big should the pilot study for my cluster randomised trial be?Stat Methods Med Res 2016;25:1039-56. 10.1177/0962280215588242 .
    1. Clark WF, Sontrop JM, Huang S-H, et al. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial. BMJ Open 2013;3:e003666 10.1136/bmjopen-2013-003666 .
    1. Buse GL, Bhandari M, Sancheti P, et al. Hip Fracture Accelerated Surgical Treatment and Care Track (HIP ATTACK) Investigators. Accelerated care versus standard care among patients with hip fracture: the HIP ATTACK pilot trial. CMAJ 2014;186:E52-60. 10.1503/cmaj.130901 .
    1. Busse M, Quinn L, Debono K, et al. Members of the COMMET-HD Management Group. A randomized feasibility study of a 12-week community-based exercise program for people with Huntington’s disease. J Neurol Phys Ther 2013;37:149-58. 10.1097/NPT.0000000000000016 .
    1. Goldstein TR, Fersch-Podrat R, Axelson DA, et al. Early intervention for adolescents at high risk for the development of bipolar disorder: pilot study of Interpersonal and Social Rhythm Therapy (IPSRT). Psychotherapy (Chic) 2014;51:180-9. 10.1037/a0034396 .
    1. Schoultz M, Atherton I, Watson A. Mindfulness-based cognitive therapy for inflammatory bowel disease patients: findings from an exploratory pilot randomised controlled trial. Trials 2015;16:379 10.1186/s13063-015-0909-5 .
    1. Hughes CW, Barnes S, Barnes C, Defina LF, Nakonezny P, Emslie GJ. Depressed Adolescents Treated with Exercise (DATE): A pilot randomized controlled trial to test feasibility and establish preliminary effect sizes. Ment Health Phys Act 2013;6:119-31. 10.1016/j.mhpa.2013.06.006 .
    1. Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687 10.1136/bmj.g1687 .
    1. Boogerd EA, Noordam C, Kremer JA, Prins JB, Verhaak CM. Teaming up: feasibility of an online treatment environment for adolescents with type 1 diabetes. Pediatr Diabetes 2014;15:394-402. 10.1111/pedi.12103 .
    1. Begh RA, Aveyard P, Upton P, et al. Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers. Trials 2011;12:197 10.1186/1745-6215-12-197 .
    1. National Institute for Health Research. Glossary | Pilot studies 2015 [cited 2015 30 June]. .
    1. Bugge C, Williams B, Hagen S, et al. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials 2013;14:353 10.1186/1745-6215-14-353 .
    1. Taylor SJ, Sohanpal R, Bremner SA, et al. Self-management support for moderate-to-severe chronic obstructive pulmonary disease: a pilot randomised controlled trial. Br J Gen Pract 2012;62:e687-95. 10.3399/bjgp12X656829 .
    1. Hamilton FL, Hornby J, Sheringham J, et al. DIgital Alcohol Management ON Demand (DIAMOND) feasibility randomised controlled trial of a web-based intervention to reduce alcohol consumption in people with hazardous and harmful use versus a face-to-face intervention: protocol. Pilot Feasibility Stud 2015;1:28.10.1186/s40814-015-0023-1.
    1. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 2005;4:287-9110.1002/pst.185.
    1. Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials 2014;15:264 10.1186/1745-6215-15-264 .
    1. Browne RH. On the use of a pilot sample for sample size determination. Stat Med 1995;14:1933-40. 10.1002/sim.4780141709 .
    1. Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res 2016;25:1057-73. 10.1177/0962280215588241 .
    1. Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol 2013;66:197-201. 10.1016/j.jclinepi.2012.09.002 .
    1. Warren FC, Stych K, Thorogood M, et al. Evaluation of different recruitment and randomisation methods in a trial of general practitioner-led interventions to increase physical activity: a randomised controlled feasibility study with factorial design. Trials 2014;15:134 10.1186/1745-6215-15-134 .
    1. Moher D, Hopewell S, Schulz KF, et al. Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:e1-37. 10.1016/j.jclinepi.2010.03.004 .
    1. Crawley E, Mills N, Beasant L, et al. The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study). Trials 2013;14:415 10.1186/1745-6215-14-415 .
    1. Cook DJ, Rocker G, Meade M, et al. PROTECT Investigators Canadian Critical Care Trials Group. Prophylaxis of Thromboembolism in Critical Care (PROTECT) Trial: a pilot study. J Crit Care 2005;20:364-72. 10.1016/j.jcrc.2005.09.010 .
    1. Schunter M, Chu H, Hayes TL, et al. Randomized pilot trial of a synbiotic dietary supplement in chronic HIV-1 infection. BMC Complement Altern Med 2012;12:84 10.1186/1472-6882-12-84 .
    1. Arnold DM, Heddle NM, Carruthers J, et al. A pilot randomized trial of adjuvant rituximab or placebo for nonsplenectomized patients with immune thrombocytopenia. Blood 2012;119:1356-62. 10.1182/blood-2011-08-374777 .
    1. Sackett DL. Commentary: Measuring the success of blinding in RCTs: don’t, must, can’t or needn’t?Int J Epidemiol 2007;36:664-5. 10.1093/ije/dym088 .
    1. Forero M, Heikkila A, Paul JE, Cheng J, Thabane L. Lumbar transversus abdominis plane block: the role of local anesthetic volume and concentration—a pilot, prospective, randomized, controlled trial. Pilot Feasibility Stud. 2015;1:10.10.1186/s40814-015-0002-6.
    1. Seebacher B, Kuisma R, Glynn A, Berger T. Rhythmic cued motor imagery and walking in people with multiple sclerosis: a randomised controlled feasibility study. Pilot Feasibility Stud. 2015;1:25.10.1186/s40814-015-0021-3.
    1. Bruhn H, Bond CM, Elliott AM, et al. Pharmacist-led management of chronic pain in primary care: results from a randomised controlled exploratory trial. BMJ Open 2013;3:e002361 10.1136/bmjopen-2012-002361 .
    1. Hopewell S, Hirst A, Collins GS, Mallett S, Yu LM, Altman DG. Reporting of participant flow diagrams in published reports of randomized trials. Trials 2011;12:253 10.1186/1745-6215-12-253 .
    1. Van Spall HG, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA 2007;297:1233-40. 10.1001/jama.297.11.1233 .
    1. Burton C, Weller D, Marsden W, Worth A, Sharpe M. A primary care Symptoms Clinic for patients with medically unexplained symptoms: pilot randomised trial. BMJ Open 2012;2:e000513 10.1136/bmjopen-2011-000513 .
    1. Egger M, Jüni P, Bartlett C. CONSORT Group (Consolidated Standards of Reporting of Trials). Value of flow diagrams in reports of randomized controlled trials. JAMA 2001;285:1996-9. 10.1001/jama.285.15.1996 .
    1. Vist GE, Hagen KB, Devereaux PJ, Bryant D, Kristoffersen DT, Oxman AD. Systematic review to determine whether participation in a trial influences outcome. BMJ 2005;330:1175 10.1136/bmj.330.7501.1175 .
    1. Boysen G, Krarup L-H, Zeng X, et al. ExStroke Pilot Trial Group. ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trial. BMJ 2009;339:b2810 10.1136/bmj.b2810 .
    1. Frech SA, Dupont HL, Bourgeois AL, et al. Use of a patch containing heat-labile toxin from Escherichia coli against travellers’ diarrhoea: a phase II, randomised, double-blind, placebo-controlled field trial. Lancet 2008;371:2019-25. 10.1016/S0140-6736(08)60839-9 .
    1. Olsen K, Howel D, Barber R, et al. Lessons from a pilot and feasibility randomised trial in depression (Blood pressure Rapid Intensive Lowering And Normal Treatment for Mood and cognition in persistent depression (BRILiANT mood study)). Pilot Feasibility Stud. 2015;1:44.10.1186/s40814-015-0042-y.
    1. Ormiston JA, Serruys PW, Regar E, et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet 2008;371:899-907. 10.1016/S0140-6736(08)60415-8 .
    1. Thomas LH, Watkins CL, Sutton CJ, et al. ICONS Project Team and the ICONS Patient, Public and Carer Involvement Groups. Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial. Trials 2014;15:509 10.1186/1745-6215-15-509 .
    1. Kapur N, Gunnell D, Hawton K, et al. Messages from Manchester: pilot randomised controlled trial following self-harm. Br J Psychiatry 2013;203:73-4. 10.1192/bjp.bp.113.126425 .
    1. Farrin A, Russell I, Torgerson D, Underwood M. UK BEAM Trial Team. Differential recruitment in a cluster randomized trial in primary care: the experience of the UK back pain, exercise, active management and manipulation (UK BEAM) feasibility study. Clin Trials 2005;2:119-24. 10.1191/1740774505cn073oa .
    1. Zisk JL, Mackley A, Clearly G, Chang E, Christensen RD, Paul DA. Transfusing neonates based on platelet count vs. platelet mass: a randomized feasibility-pilot study. Platelets 2014;25:513-6. 10.3109/09537104.2013.843072 .
    1. Pai M, Lloyd NS, Cheng J, et al. Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial. Implement Sci 2013;8:1 10.1186/1748-5908-8-1 .
    1. Jackson L, Cohen J, Sully B, Julious S. NOURISH, Nutritional OUtcomes from a Randomised Investigation of Intradialytic oral nutritional Supplements in patients receiving Haemodialysis: a pilot randomised controlled trial. Pilot Feasibility Stud. 2015;1:11.10.1186/s40814-015-0007-1.
    1. Kennedy CC, Thabane L, Ioannidis G, Adachi JD, Papaioannou A. ViDOS Investigators. Implementing a knowledge translation intervention in long-term care: feasibility results from the Vitamin D and Osteoporosis Study (ViDOS). J Am Med Dir Assoc 2014;15:943-5. 10.1016/j.jamda.2014.05.007 .
    1. Alers NO, Jenkin G, Miller SL, Wallace EM. Antenatal melatonin as an antioxidant in human pregnancies complicated by fetal growth restriction--a phase I pilot clinical trial: study protocol. BMJ Open 2013;3:e004141 10.1136/bmjopen-2013-004141 .
    1. Dyer C. UK clinical trials must be registered to win ethics committee approval. BMJ 2013;347:f5614 10.1136/bmj.f5614 .
    1. Kmietowicz Z. NHS research authority links approval of trials to registration and publication of results. BMJ 2013;346:f3119 10.1136/bmj.f3119 .
    1. World Health Organization. WHO | Welcome to the WHO ICTRP 2015 [cited 2015 30 June]. .
    1. International Committee of Medical Journal Editors. ICMJE | Clinical Trials Registration 2015 [cited 2015 30 June]. .
    1. Hecksteden A, Grütters T, Meyer T. Associations between acute and chronic effects of exercise on indicators of metabolic health: a pilot training trial. PLoS One 2013;8:e81181 10.1371/journal.pone.0081181 .
    1. Yu X, Stewart SM, Chui JP, Ho JL, Li AC, Lam TH. A pilot randomized controlled trial to decrease adaptation difficulties in chinese new immigrants to Hong Kong. Behav Ther 2014;45:137-52. 10.1016/j.beth.2013.10.003 .
    1. Items SP. Recommendation for Interventional Trials. SPIRIT | Welcome to the SPIRIT Statement website 2013 [cited 2015 30 June]. .
    1. Hip Fracture Accelerated Surgical Treatment and Care Track (HIP ATTACK) Investigators. Accelerated care versus standard care among patients with hip fracture: the HIP ATTACK pilot trial. CMAJ 2014;186:E52-60. 10.1503/cmaj.130901 .
    1. Porserud A, Sherif A, Tollbäck A. The effects of a physical exercise programme after radical cystectomy for urinary bladder cancer. A pilot randomized controlled trial. Clin Rehabil 2014;28:451-9. 10.1177/0269215513506230 .
    1. Wilson DT, Walwyn RE, Brown J, Farrin AJ, Brown SR. Statistical challenges in assessing potential efficacy of complex interventions in pilot or feasibility studies. Stat Methods Med Res 2016;25:997-1009. 10.1177/0962280215589507 .
    1. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev 2012;1:60 10.1186/2046-4053-1-60 .
    1. Penelope 2016 [18 March 2016]. .

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere