Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2014

Open Access 01-12-2014 | Research

Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

Authors: Shelley Potter, Nicola Mills, Simon J Cawthorn, Jenny Donovan, Jane M Blazeby

Published in: Trials | Issue 1/2014

Login to get access

Abstract

Background

Well-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons’ preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons’ views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons’ preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study.

Methods

Semistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved.

Results

Surgeons often struggle with the concept of equipoise. We found that if surgeons did not feel ‘in equipoise’, they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held.

Conclusion

There is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required.
Appendix
Available only for authorised users
Literature
1.
Coulter A, Entwistle V, Gilbert D: Sharing decisions with patients: is the information good enough?. BMJ. 1999, 318: 318-322. 10.1136/bmj.318.7179.318.CrossRefPubMedPubMedCentral
2.
McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J, Balliol C, Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K: No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009, 374: 1105-1112. 10.1016/S0140-6736(09)61116-8.CrossRefPubMed
3.
Buchwald H: Surgical procedures and devices should be evaluated in the same way as medical therapy. Control Clin Trials. 1997, 18: 478-487. 10.1016/S0197-2456(96)00114-6.CrossRefPubMed
4.
Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA, Reeves BC, Seiler CM, Altman DG, Aronson JK, Barkun JS, Campbell WB, Cook JA, Feldman LS, Flum DR, Glasziou P, Maddern GJ, Marshall JC, McCulloch P, Nicholl J, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Balliol Collaboration: Challenges in evaluating surgical innovation. Lancet. 2009, 374: 1097-1104. 10.1016/S0140-6736(09)61086-2.CrossRefPubMedPubMedCentral
5.
McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D: Randomised trials in surgery: problems and possible solutions. BMJ. 2002, 324: 1448-1451. 10.1136/bmj.324.7351.1448.CrossRefPubMedPubMedCentral
6.
Solomon MJ, McLeod RS: Surgery and the randomised clinical trial: past, present and future. Med J Aust. 1998, 169: 380-383.PubMed
7.
Cook JA: The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009, 10: 9-10.1186/1745-6215-10-9.CrossRefPubMedPubMedCentral
8.
Stirrat GM, Farrow SC, Farndon J, Dwyer N: The challenge of evaluating surgical procedures. Ann R Coll Surg Engl. 1992, 74: 80-84.PubMedPubMedCentral
9.
Ziebland S, Featherstone K, Snowdon C, Barker K, Frost H, Fairbank J: Does it matter if clinicians recruiting for a trial don’t understand what the trial is really about? Qualitative study of surgeons’ experiences of participation in a pragmatic multi-centre RCT. Trials. 2007, 8: 4-10.1186/1745-6215-8-4.CrossRefPubMedPubMedCentral
10.
Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S: Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012, 2: e000496-CrossRefPubMedPubMedCentral
11.
Cordeiro PG: Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008, 359: 1590-1601. 10.1056/NEJMct0802899.CrossRefPubMed
12.
Thiruchelvam PTR, McNeill F, Jallali N, Harris P, Hogben K: Post-mastectomy breast reconstruction. BMJ. 2013, 347: f5903-10.1136/bmj.f5903. A published erratum appears in BMJ 2013, 347:f6810CrossRefPubMed
13.
Gerber B, Krause A, Reimer T, Müller H, Friese K: Breast reconstruction with latissimus dorsi flap: improved aesthetic results after transection of its humeral insertion. Plast Reconstr Surg. 1876–1881, 1999: 103-
14.
Bassiouny MM, Maamoun SI, El-Shazly S, Youssef OZ: TRAM flap for immediate post mastectomy reconstruction: comparison between pedicled and free transfer. J Egypt Natl Canc Inst. 2005, 17: 231-238.PubMed
15.
Benediktsson K, Perbeck LG: Fluid retention in Bioplasty Misti Gold II breast prostheses with development of capsular contracture. Scand J Plast Reconstr Surg Hand Surg. 2000, 34: 65-70. 10.1080/02844310050160196.CrossRefPubMed
16.
Di Benedetto G, Aquinati A, Santoli M, Bertani A: Which is the best position for the remote injection dome using the adjustable expander/prosthesis in breast reconstruction? A comparative study. Plast Reconstr Surg. 2004, 113: 1629-1633. 10.1097/01.PRS.0000117193.97440.CC.CrossRefPubMed
17.
Daltrey I, Thomson H, Hussien M, Krishna K, Rayter Z, Winters ZE: Randomized clinical trial of the effect of quilting latissimus dorsi flap donor site on seroma formation. Br J Surg. 2006, 93: 825-830. 10.1002/bjs.5434.CrossRefPubMed
18.
Forouhi P, Dixon JM, Leonard RC, Chetty U: Prospective randomized study of surgical morbidity following primary systemic therapy for breast cancer. Br J Surg. 1995, 82: 79-82. 10.1002/bjs.1800820127.CrossRefPubMed
19.
Meretoja TJ, von Smitten KA, Kuokkanen HO, Suominen SH, Jahkola TA: Complications of skin-sparing mastectomy followed by immediate breast reconstruction: a prospective randomized study comparing high-frequency radiosurgery with conventional diathermy. Ann Plast Surg. 2008, 60: 24-28. 10.1097/SAP.0b013e31804a8627.CrossRefPubMed
20.
Moran SL, Nava G, Behnam AB, Serletti JM: An outcome analysis comparing the thoracodorsal and internal mammary vessels as recipient sites for microvascular breast reconstruction: a prospective study of 100 patients. Plast Reconstr Surg. 1876–1882, 2003: 111-
21.
McCarthy CM, Lee CN, Halvorson EG, Riedel E, Pusic AL, Mehrara BJ, Disa JJ: The use of acellular dermal matrices in two-stage expander/implant reconstruction: a multicenter, blinded, randomized controlled trial. Plast Reconstr Surg. 2012, 130 (5 Suppl 2): 57S-66S.CrossRefPubMedPubMedCentral
22.
Taghizadeh R, Shoaib T, Hart AM, Weiler-Mithoff EM: Triamcinolone reduces seroma re-accumulation in the extended latissimus dorsi donor site. J Plast Reconstr Aesthet Surg. 2008, 61: 636-642. 10.1016/j.bjps.2007.03.019.CrossRefPubMed
23.
Thuesen B, Siim E, Christensen L, Schrøder M: Capsular contracture after breast reconstruction with the tissue expansion technique: a comparison of smooth and textured silicone breast prostheses. Scand J Plast Reconstr Surg Hand Surg. 1995, 29: 9-13. 10.3109/02844319509048417.CrossRefPubMed
24.
Brandberg Y, Malm M, Blomqvist L: A prospective and randomized study, “SVEA”, comparing effects of three methods for delayed breast reconstruction on quality of life, patient-defined problem areas of life, and cosmetic result. Plast Reconstr Surg. 2000, 105: 66-76. 10.1097/00006534-200001000-00011.CrossRefPubMed
25.
Dean C, Chetty U, Forrest APM: Effects of immediate breast reconstruction on psychosocial morbidity after mastectomy. Lancet. 1983, 321: 459-462. 10.1016/S0140-6736(83)91452-6.CrossRef
26.
Potter S, Harcourt D, Cawthorn S, Warr R, Mills N, Havercroft D, Blazeby J: Assessment of cosmesis after breast reconstruction surgery: a systematic review. Ann Surg Oncol. 2011, 18: 813-823. 10.1245/s10434-010-1368-6.CrossRefPubMed
27.
Potter S, Brigic A, Whiting PF, Cawthorn SJ, Avery KN, Donovan JL, Blazeby JM: Reporting clinical outcomes of breast reconstruction: a systematic review. J Natl Cancer Inst. 2011, 103: 31-46. 10.1093/jnci/djq438.CrossRefPubMed
28.
Girotto JA, Schreiber J, Nahabedian MY: Breast reconstruction in the elderly: preserving excellent quality of life. Ann Plast Surg. 2003, 50: 572-578. 10.1097/01.SAP.0000069064.68579.19.CrossRefPubMed
29.
Cocquyt VF, Blondeel PN, Depypere HT, Van De Sijpe KA, Daems KK, Monstrey SJ, Van Belle SJ: Better cosmetic results and comparable quality of life after skin-sparing mastectomy and immediate autologous breast reconstruction compared to breast conservative treatment. Br J Plast Surg. 2003, 56: 462-470. 10.1016/S0007-1226(03)00198-X.CrossRefPubMed
30.
Tønseth KA, Hokland BM, Tindholdt TT, Åbyholm FE, Stavem K: Quality of life, patient satisfaction and cosmetic outcome after breast reconstruction using DIEP flap or expandable breast implant. J Plast Reconstr Aesthet Surg. 2008, 61: 1188-1194. 10.1016/j.bjps.2007.05.006.CrossRefPubMed
31.
Mullan MH, Wilkins EG, Goldfarb S, Lowery JC, Smith DM, Wickman M, Sandelin K: Prospective analysis of psychosocial outcomes after breast reconstruction: cross-cultural comparisons of 1-year postoperative results. J Plast Reconstr Aesthet Surg. 2007, 60: 503-508. 10.1016/j.bjps.2005.10.033.CrossRefPubMed
32.
Atisha A, Alderman AK, Lowery JC, Kuhn LE, Davis J, Wilkins EG: Prospective analysis of long-term psychosocial outcomes in breast reconstruction: two-year postoperative results from the Michigan Breast Reconstruction Outcome Study. Ann Surg. 2008, 247: 1019-1028. 10.1097/SLA.0b013e3181728a5c.CrossRefPubMed
33.
Alderman AK, Wilkins EG, Kim HM, Lowery JC: Complications in postmastectomy breast reconstruction: two-year results of the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg. 2002, 109: 2265-2274. 10.1097/00006534-200206000-00015.CrossRefPubMed
34.
Fogarty BJ, Brown AP, Miller R, Khan K: TRAM flap versus nonautologous breast reconstruction: what do patients really think?. Plast Reconstr Surg. 2004, 113: 1146-1152. 10.1097/01.PRS.0000110327.77037.74.CrossRefPubMed
35.
Harcourt DM, Rumsey NJ, Ambler NR, Cawthorn SJ, Reid CD, Maddox PR, Kenealy JM, Rainsbury RM, Umpleby HC: The psychological effect of mastectomy with or without breast reconstruction: a prospective, multicenter study. Plast Reconstr Surg. 2003, 111: 1060-1068. 10.1097/01.PRS.0000046249.33122.76.CrossRefPubMed
36.
Atisha DM, Alderman AK, Kuhn LE, Wilkins EG: The impact of obesity on patient satisfaction with breast reconstruction. Plast Reconstr Surg. 1893–1899, 2008: 121-
37.
Pope C, Mays N: Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. BMJ. 1995, 311: 42-45. 10.1136/bmj.311.6996.42.CrossRefPubMedPubMedCentral
38.
Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, Frankel S, Neal D, Hamdy F: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002, 325: 766-770. 10.1136/bmj.325.7367.766.CrossRefPubMedPubMedCentral
39.
Teddlie C, Yu F: Mixed methods sampling: a typology with examples. J Mixed Methods Res. 2007, 1: 77-100. 10.1177/2345678906292430.CrossRef
40.
41.
Kuper A, Reeves S, Levinson W: An introduction to reading and appraising qualitative research. BMJ. 2008, 337: a288-10.1136/bmj.a288.CrossRefPubMed
42.
43.
Kennedy TJ, Lingard LA: Making sense of grounded theory in medical education. Med Educ. 2006, 40: 101-108. 10.1111/j.1365-2929.2005.02378.x.CrossRefPubMed
44.
Kuper A, Lingard L, Levinson W: Critically appraising qualitative research. BMJ. 2008, 337: a1035-10.1136/bmj.a1035.CrossRefPubMed
45.
Glaser B, Strauss AL: The Discovery of Grounded Theory: Strategies for Qualitative Research. 1967, Chicago: Adeline
46.
Lingard L, Albert M, Levinson W: Grounded theory, mixed methods, and action research. BMJ. 2008, 337: a567-10.1136/bmj.39602.690162.47.CrossRefPubMed
47.
McGhee G, Marland GR, Atkinson J: Grounded theory research: literature reviewing and reflexivity. J Adv Nurs. 2007, 60: 334-342. 10.1111/j.1365-2648.2007.04436.x.CrossRefPubMed
48.
49.
Barbour RS: Checklists for improving rigour in qualitative research: a case of the tail wagging the dog?. BMJ. 2001, 322: 1115-1117. 10.1136/bmj.322.7294.1115.CrossRefPubMedPubMedCentral
50.
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: 349-357. 10.1093/intqhc/mzm042.CrossRefPubMed
51.
Long AF, Godfrey M: An evaluation tool to assess the quality of qualitative research studies. Int J Soc Res Methodol. 2004, 7: 181-196. 10.1080/1364557032000045302.CrossRef
52.
Meyrick J: What is good qualitative research? A first step towards a comprehensive approach to judging rigour/quality. J Health Psychol. 2006, 11: 799-808. 10.1177/1359105306066643.CrossRefPubMed
53.
Potter S, Mills N, Cawthorn S, Wilson S, Blazeby J: Exploring inequalities in access to care and the provision of choice to women seeking breast reconstruction surgery: a qualitative study. Br J Cancer. 2013, 109: 1181-1191. 10.1038/bjc.2013.461.CrossRefPubMedPubMedCentral
54.
55.
Horton R: Surgical research or comic opera: questions, but few answers. Lancet. 1996, 347: 984-985. 10.1016/S0140-6736(96)90137-3.CrossRefPubMed
56.
Bakali E, Pitchforth E, Tincello DG, Kenyon S, Slack M, Toozs-Hobson P, Mayne C, Jones DR, Taylor D: Clinicians’ views on the feasibility of surgical randomized trials in urogynecology: results of a questionnaire survey. Neurourol Urodyn. 2011, 30: 69-74. 10.1002/nau.20943.CrossRefPubMed
57.
Abraham NS, Hewett P, Young JM, Solomon MJ: Non-entry of eligible patients into the Australasian Laparoscopic Colon Cancer Study. ANZ J Surg. 2006, 76: 825-829. 10.1111/j.1445-2197.2006.03878.x.CrossRefPubMed
58.
King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M, Sibbald B, Lai R: Conceptual framework and systematic review of the effects of participants’ and professionals’ preferences in randomised controlled trials. Health Technol Assess. 2005, 9: 1-186. iii–ivCrossRefPubMed
59.
Bower P, King M, Nazareth I, Lampe F, Sibbald B: Patient preferences in randomised controlled trials: conceptual framework and implications for research. Soc Sci Med. 2005, 61: 685-695. 10.1016/j.socscimed.2004.12.010.CrossRefPubMed
60.
Bowling A, Rowe G: “You decide doctor”. What do patient preference arms in clinical trials really mean?. J Epidemiol Community Health. 2005, 59: 914-915. 10.1136/jech.2005.035261.CrossRefPubMedPubMedCentral
61.
Mills N, Donovan JL, Wade J, Hamdy FC, Neal DE, Lane JA: Exploring treatment preferences facilitated recruitment to randomized controlled trials. J Clin Epidemiol. 2011, 64: 1127-1136. 10.1016/j.jclinepi.2010.12.017.CrossRefPubMedPubMedCentral
62.
Rowe G, Lambert N, Bowling A, Ebrahim S, Wakeling I, Thomson R: Assessing patients’ preferences for treatments for angina using a modified repertory grid method. Soc Sci Med. 2005, 60: 2585-2595. 10.1016/j.socscimed.2004.10.019.CrossRefPubMed
63.
Richards H, Emslie C: The ‘doctor’ or the ‘girl from the University’? Considering the influence of professional roles on qualitative interviewing. Fam Pract. 2000, 17: 71-75. 10.1093/fampra/17.1.71.CrossRefPubMed
64.
Heneghan C: The saga of Poly Implant Prosthèse breast implants. BMJ. 2012, 344: e306-10.1136/bmj.e306.CrossRefPubMed
65.
Meakins JL: Innovation in surgery: the rules of evidence. Am J Surg. 2002, 183: 399-405. 10.1016/S0002-9610(02)00825-5.CrossRefPubMed
66.
Angelos P: The ethical challenges of surgical innovation for patient care. Lancet. 2010, 376: 1046-1047. 10.1016/S0140-6736(10)61474-2.CrossRefPubMed
67.
Biffl WL, Spain DA, Reitsma AM, Minter RM, Upperman J, Wilson M, Adams R, Goldman EB, Angelos P, Krummel T, Greenfield LJ, Society of University Surgeons Surgical Innovations Project Team: Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. J Am Coll Surg. 2008, 206: 1204-1209. 10.1016/j.jamcollsurg.2008.02.011.CrossRefPubMed
68.
Reitsma AM, Moreno JD: Ethical regulations for innovative surgery: the last frontier?. J Am Coll Surg. 2002, 194: 792-801. 10.1016/S1072-7515(02)01153-5.CrossRefPubMed
69.
Marron JM, Siegler M: Ethical issues in innovative colorectal surgery. Dis Colon Rectum. 2005, 48: 1109-1113. 10.1007/s10350-004-0892-5.CrossRefPubMed
70.
Barkun JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg SM, Altman DG, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Flum DR, Glasziou P, Marshall JC, McCulloch P, Nicholl J, Reeves BC, Seiler CM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Grant A: Evaluation and stages of surgical innovations. Lancet. 2009, 374: 1089-1096. 10.1016/S0140-6736(09)61083-7.CrossRefPubMed
71.
72.
73.
Young JM, Solomon MJ: Improving the evidence-base in surgery: evaluating surgical effectiveness. ANZ J Surg. 2003, 73: 507-510. 10.1046/j.1445-1433.2003.02662.x.CrossRefPubMed
74.
Solomon MJ, McLeod RS: Should we be performing more randomized controlled trials evaluating surgical operations?. Surgery. 1995, 118: 459-467. 10.1016/S0039-6060(05)80359-9.CrossRefPubMed
75.
Farrokhyar F, Karanicolas PJ, Thoma A, Simunovic M, Bhandari M, Devereaux PJ, Anvari M, Adili A, Guyatt G: Randomized controlled trials of surgical interventions. Ann Surg. 2010, 251: 409-416. 10.1097/SLA.0b013e3181cf863d.CrossRefPubMed
76.
Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL: Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials. 2011, 12: 78-10.1186/1745-6215-12-78.CrossRefPubMedPubMedCentral
77.
78.
79.
Kolias AG, Jones TL, Cowie CJ, Coulter IC, Afshari FT, Tarnaris A, Nelson RJ, Gray WP, Hutchinson PJ, Brennan PM, UK Neurosurgical Research Network; British Neurosurgical Trainee Research Collaborative: A report from the inaugural meeting of the British Neurosurgical Trainee Research Collaborative held in the Royal College of Surgeons of England, 19 October 2012. Br J Neurosurg. 2013, 27: 307-310.CrossRefPubMed
80.
Kolias AG, Cowie CJ, Tarnaris A, Hutchinson PJ, Brennan PM, British Neurosurgical Trainee Research Collaborative: Ensuring a bright future for clinical research in surgery with trainee led research networks. BMJ. 2013, 347: f5225-10.1136/bmj.f5225.CrossRefPubMed
81.
Bhangu A, Richardson C, Torrance A, Pinkney T, Battersby C, Beral D, Cornish J, Dent H, Hall N, Palser T, Panagiotopoulou I, Strong S, Velineni R, Panagiotopoulou I, Chatzizacharias N, Rana M, Rollins K, Ejtehadi F, Jha B, Tan Y, Fanous N, Markides G, Tan A, Marshal C, Akhtar S, Mullassery D, Ismail A, Hitchins C, Sharif S, National Surgical Research Collaborative: Multicentre observational study of performance variation in provision and outcome of emergency appendicectomy. Br J Surg. 2013, 100: 1240-1252.CrossRef
82.
Pinkney TD, Calvert M, Bartlett DC, Gheorghe A, Redman V, Dowswell G, Hawkins W, Mak T, Youssef H, Richardson C, Hornby S, Magill L, Haslop R, Wilson S, Morton D, Harrison G, Ryan R, Bradbury J, Gill M, Berkman L, Leaper D, Dunn J, Hill J, Obichere A, Ghods-Ghorbani M, Roberts T, Bhangu A, Futaba K, Harrison G, Hepburn E: Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). BMJ. 2013, 347: f4305-10.1136/bmj.f4305.CrossRefPubMedPubMedCentral
Metadata
Title
Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study
Authors
Shelley Potter
Nicola Mills
Simon J Cawthorn
Jenny Donovan
Jane M Blazeby
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-80

Other articles of this Issue 1/2014

Trials 1/2014 Go to the issue

Study protocol

Effect of percutaneous assisted approach on functional rehabilitation for total hip replacement compared to anterolateral approach: study protocol for a randomized controlled trial

Study protocol

Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial

Study protocol

Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial

Research

Comparison of anticipated and actual control group outcomes in randomised trials in paediatric oncology provides evidence that historically controlled studies are biased in favour of the novel treatment

Review

Ethical and scientific considerations for patient enrollment into concurrent clinical trials

Study protocol

Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial