TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls
Autoři:
Jeremy Howick aff001; Rebecca K. Webster aff001; Jonathan L. Rees aff001; Richard Turner aff004; Helen Macdonald aff005; Amy Price aff001; Andrea W. M. Evers aff006; Felicity Bishop aff007; Gary S. Collins aff001; Klara Bokelmann aff006; Sally Hopewell aff001; André Knottnerus aff008; Sarah Lamb aff001; Claire Madigan aff001; Vitaly Napadow aff010; Andrew N. Papanikitas aff001; Tammy Hoffmann aff011
Působiště autorů:
University of Oxford, Oxford, United Kingdom
aff001; King’s College London, London, United Kingdom
aff002; University of Oxford, Oxford, United Kingdom
aff003; Public Library of Science, San Francisco, California, United States of America and Cambridge, United Kingdom
aff004; The BMJ, London, United Kingdom
aff005; Leiden University, Leiden, The Netherlands
aff006; University of Southampton, Southampton, United Kingdom
aff007; Maastricht University, Maastricht, the Netherlands
aff008; Sydney University, Sydney, Australia
aff009; Harvard Medical School, Cambridge, Massachusetts, United States of America
aff010; Bond University, Gold Coast, Australia
aff011
Vyšlo v časopise:
TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. PLoS Med 17(9): e32767. doi:10.1371/journal.pmed.1003294
Kategorie:
Guidelines and Guidance
doi:
https://doi.org/10.1371/journal.pmed.1003294
Souhrn
Background
Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions.
Methods and findings
We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator.
Conclusions
We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.
Klíčová slova:
Acupuncture – Clinical psychology – Comparators – Physiotherapy – Psychologists – Research reporting guidelines – Surgical and invasive medical procedures – Surveys
Zdroje
1. Ellenberg SS, Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases. Ann Intern Med. 2000;133(6):464–70. 10975965.
2. Golomb BA, Erickson LC, Koperski S, Sack D, Enkin M, Howick J. What’s in placebos: who knows? Analysis of randomized, controlled trials. Annals of internal medicine. 2010;153(8):532–5.
3. Webster RK, Howick J, Hoffmann T, Macdonald H, Collins GS, Rees JL, et al. Inadequate description of placebo and sham controls in a systematic review of recent trials. Eur J Clin Invest. 2019;49(11):e13169. doi: 10.1111/eci.13169 31519047.
4. Beard DJ, Campbell MK, Blazeby JM, Carr AJ, Weijer C, Cuthbertson BH, et al. Considerations and methods for placebo controls in surgical trials. The Lancet. 2020;395(10226):828–38. doi: 10.1016/S0140-6736(19)33137-X
5. Howick J. The relativity of placebos: defending a modified version of Grünbaum’s scheme. Synthese. 2017;194(4):1363–96. doi: 10.1007/s11229-015-1001-0
6. de Craen AJ, Tijssen JG, de Gans J, Kleijnen J. Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos. J Neurol. 2000;247(3):183–8. 10787112.
7. Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008;67(12):1716–23. doi: 10.1136/ard.2008.092015 18541604.
8. Moerman DE. Meaning, medicine, and the "placebo effect". Cambridge: Cambridge University Press; 2002.
9. de Craen AJ, Roos PJ, Leonard de Vries A, Kleijnen J. Effect of colour of drugs: systematic review of perceived effect of drugs and of their effectiveness. BMJ. 1996;313(7072):1624–6. 8991013.
10. Waber RL, Shiv B, Carmon Z, Ariely D. Commercial features of placebo and therapeutic efficacy. JAMA. 2008;299(9):1016–7. doi: 10.1001/jama.299.9.1016 18319411.
11. de Craen AJ, Moerman DE, Heisterkamp SH, Tytgat GN, Tijssen JG, Kleijnen J. Placebo effect in the treatment of duodenal ulcer. Br J Clin Pharmacol. 1999;48(6):853–60. 10594490.
12. Branthwaite A, Cooper P. Analgesic effects of branding in treatment of headaches. Br Med J (Clin Res Ed). 1981;282(6276):1576–8. 6786566.
13. Faasse K, Cundy T, Gamble G, Petrie KJ. The effect of an apparent change to a branded or generic medication on drug effectiveness and side effects. Psychosom Med. 2013;75(1):90–6. doi: 10.1097/PSY.0b013e3182738826 23115341.
14. Gyotoku T, Aurelian L, Neurath AR. Cellulose acetate phthalate (CAP): an ‘inactive’ pharmaceutical excipient with antiviral activity in the mouse model of genital herpesvirus infection. Antivir Chem Chemother. 1999;10(6):327–32. 10628808.
15. Moncrieff J, Wessely S, Hardy R. Active placebos versus antidepressants for depression. Cochrane Database Syst Rev. 2004;(1):CD003012. 14974002.
16. Jefferson T, Jones M, Doshi P, Spencer EA, Onakpoya I, Heneghan CJ. Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ. 2014;348:g2545. doi: 10.1136/bmj.g2545 24811411.
17. Bello S, Wei M, Hilden J, Hrobjartsson A. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials: a methodological systematic review. BMC Med Res Methodol. 2016;16:18. doi: 10.1186/s12874-016-0111-9 26873063.
18. Hoffmann TC, Erueti C, Glasziou PP. Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials. BMJ. 2013;347:f3755. doi: 10.1136/bmj.f3755 24021722.
19. Howick J, Hoffmann T. How placebo characteristics can influence estimates of intervention effects in trials. CMAJ. 2018;190(30):E908–E11. doi: 10.1503/cmaj.171400 30061325.
20. Howick J, Bishop F, Collins G, Evers A, Hoffmann T, Lamb S, et al. TIDieR—Placebo checklist explanation and elaboration: protocol 2019. 2019 [cited 2020 Jan 1]. https://www.equator-network.org/wp-content/uploads/2019/05/TIDieR-Placebo-Protocol-v11.pdf.
21. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi: 10.1136/bmj.g1687 24609605.
22. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276(8):637–9. 8773637.
23. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010;7(3):e1000251. doi: 10.1371/journal.pmed.1000251 20352064.
24. Howick J. The Philosophy of Evidence-Based Medicine. Oxford: Wiley-Blackwell; 2011.
25. Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004;25(2):143–56. doi: 10.1016/j.cct.2003.10.016 15020033.
26. James KE, Bloch DA, Lee KK, Kraemer HC, Fuller RK. An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation—a VA cooperative study. Stat Med. 1996;15(13):1421–34.
27. Corbett MS, Watson J, Eastwood A. Randomised trials comparing different healthcare settings: an exploratory review of the impact of pre-trial preferences on participation, and discussion of other methodological challenges. BMC Health Serv Res. 2016;16(1):589. doi: 10.1186/s12913-016-1823-6 27756285.
28. Jolly K, Taylor R, Lip GY, Greenfield S, Raftery J, Mant J, et al. The Birmingham Rehabilitation Uptake Maximisation Study (BRUM). Home-based compared with hospital-based cardiac rehabilitation in a multi-ethnic population: cost-effectiveness and patient adherence. Health Technol Assess. 2007;11(35):1–118. 17767899.
29. Dalal HM, Evans PH, Campbell JL, Taylor RS, Watt A, Read KL, et al. Home-based versus hospital-based rehabilitation after myocardial infarction: A randomized trial with preference arms—Cornwall Heart Attack Rehabilitation Management Study (CHARMS). Int J Cardiol. 2007;119(2):202–11. doi: 10.1016/j.ijcard.2006.11.018
30. Walch JM, Rabin BS, Day R, Williams JN, Choi K, Kang JD. The effect of sunlight on postoperative analgesic medication use: a prospective study of patients undergoing spinal surgery. Psychosom Med. 2005;67(1):156–63. doi: 10.1097/01.psy.0000149258.42508.70 15673638.
31. Malenbaum S, Keefe FJ, Williams AC, Ulrich R, Somers TJ. Pain in its environmental context: implications for designing environments to enhance pain control. Pain. 2008;134(3):241–4. doi: 10.1016/j.pain.2007.12.002 18178010.
32. Ulrich N, Baum N. Going green in the medical office is more than wearing green. J Med Pract Manage. 2010;26(2):109–12. 21090207.
33. Singleton N, Poutawera V. Does preoperative mental health affect length of hospital stay and functional outcomes following arthroplasty surgery? A registry-based cohort study. J Orthop Surg (Hong Kong). 2017;25(2):2309499017718902. doi: 10.1177/2309499017718902 28673198.
34. Grundlingh H, Knight L, Naker D, Devries K. Secondary distress in violence researchers: a randomised trial of the effectiveness of group debriefings. BMC Psychiatry. 2017;17(1):204. doi: 10.1186/s12888-017-1327-x 28578682.
35. McClelland LE, Vogus TJ. Compassion practices and HCAHPS: does rewarding and supporting workplace compassion influence patient perceptions? Health Serv Res. 2014;49(5):1670–83. doi: 10.1111/1475-6773.12186 24837713.
36. Erlen JA, Tamres LK, Reynolds N, Golin CE, Rosen MI, Remien RH, et al. Assessing usual care in clinical trials. West J Nurs Res. 2015;37(3):288–98. Epub 2014 Mar 12. doi: 10.1177/0193945914526001 24622154.
37. Gallagher TQ, Hill C, Ojha S, Ference E, Keamy DG, Williams M, et al. Perioperative dexamethasone administration and risk of bleeding following tonsillectomy in children: a randomized controlled trial. JAMA. 2012;308(12):1221–6. doi: 10.1001/2012.jama.11575 23011712.
38. Wise RA, Bartlett SJ, Brown ED, Castro M, Cohen R, Holbrook JT, et al. Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers. The Journal of allergy and clinical immunology. 2009;124(3):436–44, 44e1–8. doi: 10.1016/j.jaci.2009.05.041 19632710.
39. van Kessel K, Moss-Morris R, Willoughby E, Chalder T, Johnson MH, Robinson E. A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue. Psychosom Med. 2008;70(2):205–13. doi: 10.1097/PSY.0b013e3181643065 18256342.
40. Suarez-Almazor ME, Looney C, Liu Y, Cox V, Pietz K, Marcus DM, et al. A randomized controlled trial of acupuncture for osteoarthritis of the knee: effects of patient-provider communication. Arthritis Care Res (Hoboken). 2010;62(9):1229–36. doi: 10.1002/acr.20225 20506122.
41. Thomas KS, Crook AM, Nunn AJ, Foster KA, Mason JM, Chalmers JR, et al. Penicillin to prevent recurrent leg cellulitis. N Engl J Med. 2013;368(18):1695–703. doi: 10.1056/NEJMoa1206300 23635049.
42. Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995;152(9):1423–33. 7728691.
43. Ruben MA, Blanch-Hartigan D, Hall JA. Nonverbal Communication as a Pain Reliever: The Impact of Physician Supportive Nonverbal Behavior on Experimentally Induced Pain. Health Commun. 2017;32(8):970–6. Epub 2016 Jul 27. doi: 10.1080/10410236.2016.1196418 27463408.
44. Ulrich RS, Cordoza M, Gardiner SK, Manulik BJ, Fitzpatrick PS, Hazen TM, et al. ICU Patient Family Stress Recovery During Breaks in a Hospital Garden and Indoor Environments. HERD. 2020;13(2): 83–102. Epub 2019 Aug 7. doi: 10.1177/1937586719867157 31390887.
45. Hedman E, Andersson G, Andersson E, Ljotsson B, Ruck C, Asmundson GJ, et al. Internet-based cognitive-behavioural therapy for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2011;198(3):230–6. doi: 10.1192/bjp.bp.110.086843 21357882.
46. Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. J Physiother. 2012;58(2):89–95. doi: 10.1016/S1836-9553(12)70088-7 22613238.
47. Howe LC, Goyer JP, Crum AJ. Harnessing the placebo effect: Exploring the influence of physician characteristics on placebo response. Health Psychology. 2017;36:1074–82.
48. Gonzalez-Iglesias J, Fernandez-de-Las-Penas C, Cleland JA, Huijbregts P, Del Rosario Gutierrez-Vega M. Short-term effects of cervical kinesio taping on pain and cervical range of motion in patients with acute whiplash injury: a randomized clinical trial. J Orthop Sports Phys Ther. 2009;39(7):515–21. doi: 10.2519/jospt.2009.3072 19574662.
49. Madigan CD, Jolly K, Roalfe A, Lewis AL, Webber L, Aveyard P, et al. Study protocol: the effectiveness and cost effectiveness of a brief behavioural intervention to promote regular self-weighing to prevent weight regain after weight loss: randomised controlled trial (The LIMIT Study). BMC Public Health. 2015;15:530. doi: 10.1186/s12889-015-1869-0 26041653.
50. Beard DJ, Rees JL, Cook JA, Rombach I, Cooper C, Merritt N, et al. Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet. 2018;391(10118):329–38. Epub 2017 Nov 20. doi: 10.1016/S0140-6736(17)32457-1 29169668.
51. Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008;336(7651):999–1003. 18390493.
52. collaborators C-t, Shakur H, Roberts I, Bautista R, Caballero J, Coats T, et al. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010;376(9734):23–32. doi: 10.1016/S0140-6736(10)60835-5 20554319.
53. Parreira PdCS, Costa LdCM, Takahashi R, Junior LCH, Junior MAdL, Silva TMd, et al. Kinesio Taping to generate skin convolutions is not better than sham taping for people with chronic non-specific low back pain: a randomised trial. Journal of Physiotherapy. 2014;60:90–6. http://dx.doi.org/10.1016/j.jphys.2014.05.003.
54. Abou-Alfa GK, Meyer T, Cheng AL, El-Khoueiry AB, Rimassa L, Ryoo BY, et al. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma. N Engl J Med. 2018;379(1):54–63. doi: 10.1056/NEJMoa1717002 29972759.
55. Heine M, Verschuren O, Hoogervorst EL, van Munster E, Hacking HG, Visser-Meily A, et al. Does aerobic training alleviate fatigue and improve societal participation in patients with multiple sclerosis? A randomized controlled trial. Mult Scler. 2017;23(11):1517–26. doi: 10.1177/1352458517696596 28528566.
56. LeWitt PA, Rezai AR, Leehey MA, Ojemann SG, Flaherty AW, Eskandar EN, et al. AAV2-GAD gene therapy for advanced Parkinson’s disease: a double-blind, sham-surgery controlled, randomised trial. Lancet Neurol. 2011;10(4):309–19. doi: 10.1016/S1474-4422(11)70039-4 21419704.
57. Adams R, Brown E, Brown L, Butler R, Falk S, Fisher D, et al. Inhibition of EGFR, HER2, and HER3 signalling in patients with colorectal cancer wild-type for BRAF, PIK3CA, KRAS, and NRAS (FOCUS4-D): a phase 2–3 randomised trial. Lancet Gastroenterol Hepatol. 2018;3(3):162–71. Epub 2017 Dec 16. doi: 10.1016/S2468-1253(17)30394-1
58. Keating SE, Hackett DA, Parker HM, O’Connor HT, Gerofi JA, Sainsbury A, et al. Effect of aerobic exercise training dose on liver fat and visceral adiposity. J Hepatol. 2015;63(1):174–82. doi: 10.1016/j.jhep.2015.02.022 25863524.
59. Coombes BK, Bisset L, Brooks P, Khan A, Vicenzino B. Effect of corticosteroid injection, physiotherapy, or both on clinical outcomes in patients with unilateral lateral epicondylalgia: a randomized controlled trial. JAMA. 2013;309(5):461–9. doi: 10.1001/jama.2013.129 23385272.
60. Choy O, Raine A, Hamilton RH. Stimulation of the Prefrontal Cortex Reduces Intentions to Commit Aggression: A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group Trial. J Neurosci. 2018;38(29):6505–12. doi: 10.1523/JNEUROSCI.3317-17.2018 29967006.
Článek vyšel v časopise
PLOS Medicine
2020 Číslo 9
- S diagnostikou Parkinsonovy nemoci může nově pomoci AI nástroj pro hodnocení mrkacího reflexu
- Proč při poslechu některé muziky prostě musíme tančit?
- Chůze do schodů pomáhá prodloužit život a vyhnout se srdečním chorobám
- „Jednohubky“ z klinického výzkumu – 2024/44
- Je libo čepici místo mozkového implantátu?
Nejčtenější v tomto čísle
- Interventions for treatment of COVID-19: A living systematic review with meta-analyses and trial sequential analyses (The LIVING Project)
- COVID-19 prevention and treatment: A critical analysis of chloroquine and hydroxychloroquine clinical pharmacology
- Comorbidities associated with mortality in 31,461 adults with COVID-19 in the United States: A federated electronic medical record analysis
- Long-term survival of children born with congenital anomalies: A systematic review and meta-analysis of population-based studies
