NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Beard DJ, Campbell MK, Blazeby JM, et al. Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop. Southampton (UK): NIHR Journals Library; 2021 Sep. (Health Technology Assessment, No. 25.53.)
Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.
Show details- 1.
- BlencoweNS, CookJA, PinkneyT, RogersC, ReevesBC, BlazebyJM. Delivering successful randomized controlled trials in surgery: methods to optimize collaboration and study design. Clin Trials2017;14:211–18. 10.1177/1740774516687272 [PubMed: 28135839] [CrossRef]
- 2.
- WartolowskaKA, GerryS, FeakinsBG, CollinsGS, CookJ, JudgeA, CarrAJ. A meta-analysis of temporal changes of response in the placebo arm of surgical randomized controlled trials: an update. Trials2017;18:323. 10.1186/s13063-017-2070-9 [PMC free article: PMC5508709] [PubMed: 28701195] [CrossRef]
- 3.
- GuAP, GuCN, AhmedAT, MuradMH, WangZ, KallmesDF, BrinjikjiW. Sham surgical procedures for pain intervention result in significant improvements in pain: systematic-review and meta-analysis: metaepidemiologic research requires reporting requirements. J Clin Epidemiol2017;87:108. 10.1016/j.jclinepi.2017.03.006 [PubMed: 28341365] [CrossRef]
- 4.
- JonasWB, CrawfordC, CollocaL, KaptchukTJ, MoseleyB, MillerFG, et al.To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomised, sham controlled trials. BMJ Open2015;5:e009655. 10.1136/bmjopen-2015-009655 [PMC free article: PMC4679929] [PubMed: 26656986] [CrossRef]
- 5.
- WartolowskaK, JudgeA, HopewellS, CollinsGS, DeanBJ, RombachI, et al.Use of placebo controls in the evaluation of surgery: systematic review. BMJ2014;348:g3253. 10.1136/bmj.g3253 [PMC free article: PMC4029190] [PubMed: 24850821] [CrossRef]
- 6.
- ProbstP, GrummichK, HarnossJC, HüttnerFJ, JensenK, BraunS, et al.Placebo-controlled trials in surgery: a systematic review and meta-analysis. Medicine2016;95:e3516. 10.1097/MD.0000000000003516 [PMC free article: PMC4998723] [PubMed: 27124060] [CrossRef]
- 7.
- WartolowskaK, CollinsGS, HopewellS, JudgeA, DeanBJ, RombachI, et al.Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review. BMJ Open2016;6:e010194. 10.1136/bmjopen-2015-010194 [PMC free article: PMC4800115] [PubMed: 27008687] [CrossRef]
- 8.
- CampbellMK, EntwistleVA, CuthbertsonBH, SkeaZC, SutherlandAG, McDonaldAM, et al.Developing a placebo-controlled trial in surgery: issues of design, acceptability and feasibility. Trials2011;12:50. 10.1186/1745-6215-12-50 [PMC free article: PMC3052178] [PubMed: 21338481] [CrossRef]
- 9.
- BlencoweNS, MillsN, CookJA, DonovanJL, RogersCA, WhitingP, BlazebyJM. Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials. Br J Surg2016;103:1377–84. 10.1002/bjs.10254 [PMC free article: PMC5132147] [PubMed: 27462835] [CrossRef]
- 10.
- EdwardsM. Placebo. Lancet2005;365:1023. 10.1016/S0140-6736(05)71124-7 [PubMed: 15781087] [CrossRef]
- 11.
- SavulescuJ, WartolowskaK, CarrA. Randomised placebo-controlled trials of surgery: ethical analysis and guidelines. J Med Ethics2016;42:776–83. 10.1136/medethics-2015-103333 [PMC free article: PMC5256399] [PubMed: 27777269] [CrossRef]
- 12.
- BeardDJ, CampbellMK, BlazebyJM, CarrAJ, WeijerC, CuthbertsonBH, et al.Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines). Lancet2020;395:828–38. 10.1016/S0140-6736(19)33137-X [PubMed: 32145797] [CrossRef]
- 13.
- BeardDJ, ReesJL, CookJA, RombachI, CooperC, MerrittN, et al.Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet2018;391:329–38. 10.1016/S0140-6736(17)32457-1 [PMC free article: PMC5803129] [PubMed: 29169668] [CrossRef]
- 14.
- MowbrayCT, HolterMC, TeagueGB, BybeeD. Fidelity criteria: development, measurement, and validation. Am J Eval2003;24:315–40. 10.1177/109821400302400303 [CrossRef]
- 15.
- CousinsS, BlencoweNS, TsangC, ChalmersK, MardanpourA, CarrAJ, et al.Optimizing the design of invasive placebo interventions in randomized controlled trials. Br J Surg2020;107:1114–22. 10.1002/bjs.11509 [PMC free article: PMC7496319] [PubMed: 32187680] [CrossRef]
- 16.
- HardmanDI, GeraghtyAW, LewithG, LownM, ViecelliC, BishopFL. From substance to process: a meta-ethnographic review of how healthcare professionals and patients understand placebos and their effects in primary care. Health2020;24:315–40. 10.1177/1363459318800169 [PubMed: 30238795] [CrossRef]
- 17.
- BrodyBA. Placebos in clinical trials: new forms of an old issue. Health Law News2000;13:4, 14. [PubMed: 12542041]
- 18.
- MoermanDE, JonasWB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med2002;136:471–6. 10.7326/0003-4819-136-6-200203190-00011 [PubMed: 11900500] [CrossRef]
- 19.
- CollocaL. The placebo effect in pain therapies. Annu Rev Pharmacol Toxicol2019;59:191–211. 10.1146/annurev-pharmtox-010818-021542 [PMC free article: PMC6402571] [PubMed: 30216744] [CrossRef]
- 20.
- Stewart-WilliamsS, PoddJ. The placebo effect: dissolving the expectancy versus conditioning debate. Psychol Bull2004;130:324–40. 10.1037/0033-2909.130.2.324 [PubMed: 14979775] [CrossRef]
- 21.
- BenedettiF. Mechanisms of placebo and placebo-related effects across diseases and treatments. Annu Rev Pharmacol Toxicol2008;48:33–60. 10.1146/annurev.pharmtox.48.113006.094711 [PubMed: 17666008] [CrossRef]
- 22.
- CollocaL, MillerFG. How placebo responses are formed: a learning perspective. Philos Trans R Soc Lond B Biol Sci2011;366:1859–69. 10.1098/rstb.2010.0398 [PMC free article: PMC3130403] [PubMed: 21576143] [CrossRef]
- 23.
- WickramasekeraI. A conditioned response model of the placebo effect predictions from the model. Biofeedback Self Regul1980;5:5–18. 10.1007/BF00999060 [PubMed: 7370359] [CrossRef]
- 24.
- KaptchukTJ. Placebo studies and ritual theory: a comparative analysis of Navajo, acupuncture and biomedical healing. Philos Trans R Soc Lond B Biol Sci2011;366:1849–58. 10.1098/rstb.2010.0385 [PMC free article: PMC3130398] [PubMed: 21576142] [CrossRef]
- 25.
- CollocaL, BenedettiF. Placebo analgesia induced by social observational learning. Pain2009;144:28–34. 10.1016/j.pain.2009.01.033 [PubMed: 19278785] [CrossRef]
- 26.
- Di BlasiZ, HarknessE, ErnstE, GeorgiouA, KleijnenJ. Influence of context effects on health outcomes: a systematic review. Lancet2001;357:757–62. [PubMed: 11253970]
- 27.
- BishopFL, CoghlanB, GeraghtyAW, EverittH, LittleP, HolmesMM, et al.What techniques might be used to harness placebo effects in non-malignant pain? A literature review and survey to develop a taxonomy. BMJ Open2017;7:e015516. 10.1136/bmjopen-2016-015516 [PMC free article: PMC5734496] [PubMed: 28667217] [CrossRef]
- 28.
- WhiteP, BishopFL, PrescottP, ScottC, LittleP, LewithG. Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture. Pain2012;153:455–62. 10.1016/j.pain.2011.11.007 [PubMed: 22169359] [CrossRef]
- 29.
- BleaseCR, BishopFL, KaptchukTJ. Informed consent and clinical trials: where is the placebo effect?BMJ2017;356:j463. 10.1136/bmj.j463 [PMC free article: PMC6888513] [PubMed: 28159769] [CrossRef]
- 30.
- BishopFL, AdamsAE, KaptchukTJ, LewithGT. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos. PLOS ONE2012;7:e39661. 10.1371/journal.pone.0039661 [PMC free article: PMC3384614] [PubMed: 22761859] [CrossRef]
- 31.
- Di BlasiZ, CrawfordF, BradleyC, KleijnenJ. Reactions to treatment debriefing among the participants of a placebo controlled trial. BMC Health Serv Res2005;5:30. 10.1186/1472-6963-5-30 [PMC free article: PMC1112594] [PubMed: 15847683] [CrossRef]
- 32.
- EippertF, FinsterbuschJ, BingelU, BüchelC. Direct evidence for spinal cord involvement in placebo analgesia. Science2009;326:404. 10.1126/science.1180142 [PubMed: 19833962] [CrossRef]
- 33.
- ScottDJ, StohlerCS, EgnatukCM, WangH, KoeppeRA, ZubietaJK. Individual differences in reward responding explain placebo-induced expectations and effects. Neuron2007;55:325–36. 10.1016/j.neuron.2007.06.028 [PubMed: 17640532] [CrossRef]
- 34.
- SchweinhardtP, SeminowiczDA, JaegerE, DuncanGH, BushnellMC. The anatomy of the mesolimbic reward system: a link between personality and the placebo analgesic response. J Neurosci2009;29:4882–7. 10.1523/JNEUROSCI.5634-08.2009 [PMC free article: PMC6665321] [PubMed: 19369556] [CrossRef]
- 35.
- TraceyI. Getting the pain you expect: mechanisms of placebo, nocebo and reappraisal effects in humans. Nat Med2010;16:1277–83. 10.1038/nm.2229 [PubMed: 20948533] [CrossRef]
- 36.
- PloghausA, NarainC, BeckmannCF, ClareS, BantickS, WiseR, et al.Exacerbation of pain by anxiety is associated with activity in a hippocampal network. J Neurosci2001;21:9896–903. 10.1523/JNEUROSCI.21-24-09896.2001 [PMC free article: PMC6763058] [PubMed: 11739597] [CrossRef]
- 37.
- American Medical Association. Ethical Use of Placebo Controls in Research. Chicago, IL: American Medical Association; 2017.
- 38.
- CampbellMK, SkeaZC, SutherlandAG, CuthbertsonBH, EntwistleVA, McDonaldAM, et al.Effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee: a mixed methods study of the feasibility of conducting a surgical placebo-controlled trial (the KORAL study). Health Technol Assess2010;14(5). 10.3310/hta14040 [PubMed: 20113674] [CrossRef]
- 39.
- Royal College of Surgeons of England. Position statement: use of placebo surgery in surgical research. Bull R Coll Surg Engl2016:80–1. 10.1308/rcsbull.2016.80 [CrossRef]
- 40.
- Canadian Medical Association. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 2010. URL: https://policybase
.cma .ca/en/viewer?file= %2fdocuments%2fPolicyPDF%2fPD19-03 .pdf#phrase=false (accessed May 2018). - 41.
- German Medical Association. Placebo in der Medizin. Berlin: German Medical Association; 2010.
- 42.
- New Zealand Medical Association. Code of Ethics for the New Zealand Medical Association. Wellington: New Zealand Medical Association; 2014.
- 43.
- CousinsS, BlencoweNS, TsangC, LorencA, ChalmersK, CarrAJ, et al.Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review. J Clin Epidemiol2020;119:109–16. 10.1016/j.jclinepi.2019.11.016 [PMC free article: PMC7066579] [PubMed: 31786153] [CrossRef]
- 44.
- ThomsenJ, BretlauP, TosM, JohnsenNJ. Ménière’s disease: endolymphatic sac decompression compared with sham (placebo) decompression. Ann N Y Acad Sci1981;374:820–30. 10.1111/j.1749-6632.1981.tb30922.x [PubMed: 7041752] [CrossRef]
- 45.
- Al-LameeR, ThompsonD, DehbiHM, SenS, TangK, DaviesJ, et al.Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet2018;391:31–40. 10.1016/S0140-6736(17)32714-9 [PubMed: 29103656] [CrossRef]
- 46.
- PaavolaM, MalmivaaraA, TaimelaS, KantoK, JärvinenTL, FIMPACT Investigators. Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT): a protocol for a randomised trial comparing arthroscopic subacromial decompression and diagnostic arthroscopy (placebo control), with an exercise therapy control, in the treatment of shoulder impingement syndrome. BMJ Open2017;7:e014087. 10.1136/bmjopen-2016-014087 [PMC free article: PMC5734212] [PubMed: 28588109] [CrossRef]
- 47.
- SwankDJ, Swank-BordewijkSC, HopWC, van ErpWF, JanssenIM, BonjerHJ, JeekelJ. Laparoscopic adhesiolysis in patients with chronic abdominal pain: a blinded randomised controlled multi-centre trial. Lancet2003;361:1247–51. 10.1016/S0140-6736(03)12979-0 [PubMed: 12699951] [CrossRef]
- 48.
- HåkanssonB, MontgomeryM, CadiereGB, RajanA, Bruley des VarannesS, LerhunM, et al.Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther2015;42:1261–70. 10.1111/apt.13427 [PubMed: 26463242] [CrossRef]
- 49.
- JarrellJ, MohindraR, RossS, TaenzerP, BrantR. Laparoscopy and reported pain among patients with endometriosis. J Obstet Gynaecol Can2005;27:477–85. 10.1016/S1701-2163(16)30531-X [PubMed: 16100643] [CrossRef]
- 50.
- BuchbinderR, OsborneRH, EbelingPR, WarkJD, MitchellP, WriedtC, et al.A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med2009;361:557–68. 10.1056/NEJMoa0900429 [PubMed: 19657121] [CrossRef]
- 51.
- BajboujM, BeckerV, EckelF, MiehlkeS, PechO, PrinzC, et al.Argon plasma coagulation of cervical heterotopic gastric mucosa as an alternative treatment for globus sensations. Gastroenterology2009;137:440–4. 10.1053/j.gastro.2009.04.053 [PubMed: 19410576] [CrossRef]
- 52.
- CastroM, RubinAS, LavioletteM, FitermanJ, De Andrade LimaM, ShahPL, et al.Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med2010;181:116–24. 10.1164/rccm.200903-0354OC [PMC free article: PMC3269231] [PubMed: 19815809] [CrossRef]
- 53.
- CobbLA, ThomasGI, DillardDH, MerendinoKA, BruceRA. An evaluation of internal-mammary-artery ligation by a double-blind technic. N Engl J Med1959;260:1115–18. 10.1056/NEJM195905282602204 [PubMed: 13657350] [CrossRef]
- 54.
- CorleyDA, KatzP, WoJM, StefanA, PattiM, RothsteinR, et al.Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology2003;125:668–76. 10.1016/S0016-5085(03)01052-7 [PubMed: 12949712] [CrossRef]
- 55.
- CottonPB, DurkalskiV, RomagnuoloJ, PaulsQ, FogelE, TarnaskyP, et al.Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial. JAMA2014;311:2101–9. 10.1001/jama.2014.5220 [PMC free article: PMC4428324] [PubMed: 24867013] [CrossRef]
- 56.
- DevièreJ, CostamagnaG, NeuhausH, VoderholzerW, LouisH, TringaliA, et al.Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multicenter trial. Gastroenterology2005;128:532–40. 10.1053/j.gastro.2004.12.005 [PubMed: 15765387] [CrossRef]
- 57.
- DowsonA, MullenMJ, PeatfieldR, MuirK, KhanAA, WellsC, et al.Migraine Intervention With STARFlex Technology (MIST) trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation2008;117:1397–404. 10.1161/CIRCULATIONAHA.107.727271 [PubMed: 18316488] [CrossRef]
- 58.
- FriedmanM, SchalchP, LinHC, KakodkarKA, JosephNJ, MazloomN. Palatal implants for the treatment of snoring and obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg2008;138:209–16. 10.1016/j.otohns.2007.10.026 [PubMed: 18241718] [CrossRef]
- 59.
- GencoA, CiprianoM, BacciV, CuzzolaroM, MateriaA, RaparelliL, et al.BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes2006;30:129–33. 10.1038/sj.ijo.0803094 [PubMed: 16189503] [CrossRef]
- 60.
- LeonMB, KornowskiR, DowneyWE, WeiszG, BaimDS, BonowRO, et al.A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. J Am Coll Cardiol2005;46:1812–19. 10.1016/j.jacc.2005.06.079 [PubMed: 16286164] [CrossRef]
- 61.
- OlanowCW, GoetzCG, KordowerJH, et al.A double-blind controlled trial of bilateral fetal nigral transplantation in Parkinson’s disease. Ann Neurol2003;54:403–14. 10.1002/ana.10720 [PubMed: 12953276] [CrossRef]
- 62.
- PauzaKJ, HowellS, DreyfussP, PelozaJH, DawsonK, BogdukN. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J2004;4:27–35. 10.1016/j.spinee.2003.07.001 [PubMed: 14749191] [CrossRef]
- 63.
- RamhamadanyEM, FowlerJ, BairdIM. Effect of the gastric balloon versus sham procedure on weight loss in obese subjects. Gut1989;30:1054–7. 10.1136/gut.30.8.1054 [PMC free article: PMC1434178] [PubMed: 2767500] [CrossRef]
- 64.
- RothsteinR, FilipiC, CacaK, PruittR, MergenerK, TorquatiA, et al.Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: a randomized, sham-controlled trial. Gastroenterology2006;131:704–12. 10.1053/j.gastro.2006.07.004 [PubMed: 16952539] [CrossRef]
- 65.
- SalemM, RotevatnS, StavnesS, BrekkeM, VollsetSE, NordrehaugJE. Usefulness and safety of percutaneous myocardial laser revascularization for refractory angina pectoris. Am J Cardiol2004;93:1086–91. 10.1016/j.amjcard.2004.01.032 [PubMed: 15110197] [CrossRef]
- 66.
- SchwartzMP, WellinkH, GooszenHG, ConchilloJM, SamsomM, SmoutAJ. Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial. Gut2007;56:20–8. 10.1136/gut.2006.096842 [PMC free article: PMC1856666] [PubMed: 16763053] [CrossRef]
- 67.
- StoneGW, TeirsteinPS, RubensteinR, SchmidtD, WhitlowPL, KosinskiEJ, et al.A prospective, multicenter, randomized trial of percutaneous transmyocardial laser revascularization in patients with nonrecanalizable chronic total occlusions. J Am Coll Cardiol2002;39:1581–7. 10.1016/S0735-1097(02)01829-6 [PubMed: 12020483] [CrossRef]
- 68.
- SuttonCJ, EwenSP, WhitelawN, HainesP. Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis. Fertil Steril1994;62:696–700. 10.1016/S0015-0282(16)56990-8 [PubMed: 7926075] [CrossRef]
- 69.
- KallmesDF, ComstockBA, HeagertyPJ, TurnerJA, WilsonDJ, DiamondTH, et al.A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med2009;361:569–79. 10.1056/NEJMoa0900563 [PMC free article: PMC2930487] [PubMed: 19657122] [CrossRef]
- 70.
- SchrøderCP, SkareØ, ReikeråsO, MowinckelP, BroxJI. Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial. Br J Sports Med2017;51:1759–66. 10.1136/bjsports-2016-097098 [PMC free article: PMC5754846] [PubMed: 28495804] [CrossRef]
- 71.
- FreedCR, GreenePE, BreezeRE, et al.Transplantation of embryonic dopamine neurons for severe Parkinson’s disease. N Engl J Med2001;344:710–19. 10.1056/NEJM200103083441002 [PubMed: 11236774] [CrossRef]
- 72.
- MoseleyJB, O’MalleyK, PetersenNJ, MenkeTJ, BrodyBA, KuykendallDH, et al.A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med2002;347:81–8. 10.1056/NEJMoa013259 [PubMed: 12110735] [CrossRef]
- 73.
- ArtsJ, BisschopsR, BlondeauK, FarréR, VosR, HolvoetL, et al.A double-blind sham-controlled study of the effect of radiofrequency energy on symptoms and distensibility of the gastro-esophageal junction in GERD. Am J Gastroenterol2012;107:222–30. 10.1038/ajg.2011.395 [PubMed: 22108449] [CrossRef]
- 74.
- BenjaminSB, MaherKA, CattauELJr., et al.Double-blind controlled trial of the Garren-Edwards gastric bubble: an adjunctive treatment for exogenous obesity. Gastroenterology1988;95:581–8. 10.1016/S0016-5085(88)80001-5 [PubMed: 3294079] [CrossRef]
- 75.
- DavysHJ, TurnerDE, HelliwellPS, ConaghanPG, EmeryP, WoodburnJ. Debridement of plantar callosities in rheumatoid arthritis: a randomized controlled trial. Rheumatology2005;44:207–10. 10.1093/rheumatology/keh435 [PubMed: 15479752] [CrossRef]
- 76.
- StewardDL, HuntleyTC, WoodsonBT, SurdulescuV. Palate implants for obstructive sleep apnea: multi-institution, randomized, placebo-controlled study. Otolaryngol Head Neck Surg2008;139:506–10. 10.1016/j.otohns.2008.07.021 [PubMed: 18922335] [CrossRef]
- 77.
- KoutsourelakisI, GeorgoulopoulosG, PerrakiE, VagiakisE, RoussosC, ZakynthinosSG. Randomised trial of nasal surgery for fixed nasal obstruction in obstructive sleep apnoea. Eur Respir J2008;31:110–17. 10.1183/09031936.00087607 [PubMed: 17898015] [CrossRef]
- 78.
- SihvonenR, PaavolaM, MalmivaaraA, ItäläA, JoukainenA, NurmiH, et al.Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med2013;369:2515–24. 10.1056/NEJMoa1305189 [PubMed: 24369076] [CrossRef]
- 79.
- LarrosaF, HernandezL, MorelloA, BallesterE, QuintoL, MontserratJM. Laser-assisted uvulopalatoplasty for snoring: does it meet the expectations?Eur Respir J2004;24:66–70. 10.1183/09031936.04.00082903 [PubMed: 15293606] [CrossRef]
- 80.
- BuchbinderR, OsborneRH, KallmesD. Vertebroplasty appears no better than placebo for painful osteoporotic spinal fractures, and has potential to cause harm. Med J Aust2009;191:476–7. 10.5694/j.1326-5377.2009.tb02906.x [PubMed: 19883338] [CrossRef]
- 81.
- StuckBA, SauterA, HörmannK, VerseT, MaurerJT. Radiofrequency surgery of the soft palate in the treatment of snoring. A placebo-controlled trial. Sleep2005;28:847–50. 10.1093/sleep/28.7.847 [PubMed: 16124664] [CrossRef]
- 82.
- Sclerotherapy for male alcoholic cirrhotic patients who have bled from esophageal varices: results of a randomized, multicenter clinical trial. The Veterans Affairs Cooperative Variceal Sclerotherapy Group. Hepatology1994;20:618–25. 10.1016/0270-9139(94)90096-5 [PubMed: 8076919] [CrossRef]
- 83.
- MacLeodIA, MillsPR, MacKenzieJF, JoffeSN, RussellRI, CarterDC. Neodymium yttrium aluminium garnet laser photocoagulation for major haemorrhage from peptic ulcers and single vessels: a single blind controlled study. Br Med J1983;286:345–8. 10.1136/bmj.286.6362.345 [PMC free article: PMC1546915] [PubMed: 6402091] [CrossRef]
- 84.
- IkramuddinS, BlackstoneRP, BrancatisanoA, ToouliJ, ShahSN, WolfeBM, et al.Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial. JAMA2014;312:915–22. 10.1001/jama.2014.10540 [PubMed: 25182100] [CrossRef]
- 85.
- AbbottJ, HaweJ, HunterD, HolmesM, FinnP, GarryR. Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial. Fertil Steril2004;82:878–84. 10.1016/j.fertnstert.2004.03.046 [PubMed: 15482763] [CrossRef]
- 86.
- EidGM, McCloskeyCA, EagletonJK, LeeLB, CourcoulasAP. StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients: a randomized clinical trial. JAMA Surg2014;149:372–9. 10.1001/jamasurg.2013.4051 [PubMed: 24554030] [CrossRef]
- 87.
- FleischerD. Endoscopic Nd:YAG laser therapy for active esophageal variceal bleeding. A randomized controlled study. Gastrointest Endosc1985;31:4–9. 10.1016/s0016-5107(85)71954-2 [PubMed: 3872241] [CrossRef]
- 88.
- FreemanBJ, FraserRD, CainCM, HallDJ, ChappleDC. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine2005;30:2369–77. 10.1097/01.brs.0000186587.43373.f2 [PubMed: 16261111] [CrossRef]
- 89.
- GeenenJE, HoganWJ, DoddsWJ, ToouliJ, VenuRP. The efficacy of endoscopic sphincterotomy after cholecystectomy in patients with sphincter-of-Oddi dysfunction. N Engl J Med1989;320:82–7. 10.1056/NEJM198901123200203 [PubMed: 2643038] [CrossRef]
- 90.
- GuyuronB, ReedD, KrieglerJS, DavisJ, PashminiN, AminiS. A placebo-controlled surgical trial of the treatment of migraine headaches. Plast Reconstr Surg2009;124:461–8. 10.1097/PRS.0b013e3181adcf6a [PubMed: 19644260] [CrossRef]
- 91.
- HeidariM, PaknejadM, JamaliR, NokhbatolfoghahaeiH, FekrazadR, MoslemiN. Effect of laser photobiomodulation on wound healing and postoperative pain following free gingival graft: a split-mouth triple-blind randomized controlled clinical trial. J Photochem Photobiol B2017;172:109–14. 10.1016/j.jphotobiol.2017.05.022 [PubMed: 28549319] [CrossRef]
- 92.
- HoganRB, JohnstonJH, LongBW, SonesJQ, HintonLA, BungeJ, CorriganSA. A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity. Gastrointest Endosc1989;35:381–5. 10.1016/S0016-5107(89)72839-X [PubMed: 2792672] [CrossRef]
- 93.
- LeePE, KungRC, DrutzHP. Periurethral autologous fat injection as treatment for female stress urinary incontinence: a randomized double-blind controlled trial. J Urol2001;165:153–8. 10.1097/00005392-200101000-00037 [PubMed: 11125386] [CrossRef]
- 94.
- MontgomeryM, HåkansonB, LjungqvistO, AhlmanB, ThorellA. Twelve months’ follow-up after treatment with the EndoCinch endoscopic technique for gastro-oesophageal reflux disease: a randomized, placebo-controlled study. Scand J Gastroenterol2006;41:1382–9. 10.1080/00365520600735738 [PubMed: 17101568] [CrossRef]
- 95.
- NeaseCJ, KremplGA. Radiofrequency treatment of turbinate hypertrophy: a randomized, blinded, placebo-controlled clinical trial. Otolaryngol Head Neck Surg2004;130:291–9. 10.1016/j.otohns.2003.11.003 [PubMed: 15054369] [CrossRef]
- 96.
- PowellNB, ZonatoAI, WeaverEM, LiK, TroellR, RileyRW, GuilleminaultC. Radiofrequency treatment of turbinate hypertrophy in subjects using continuous positive airway pressure: a randomized, double-blind, placebo-controlled clinical pilot trial. Laryngoscope2001;111:1783–90. 10.1097/00005537-200110000-00023 [PubMed: 11801946] [CrossRef]
- 97.
- RoehrbornCG, GangeSN, ShoreND, GiddensJL, BoltonDM, CowanBE, et al.The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. J Urol2013;190:2161–7. 10.1016/j.juro.2013.05.116 [PubMed: 23764081] [CrossRef]
- 98.
- SarrMG, BillingtonCJ, BrancatisanoR, BrancatisanoA, ToouliJ, KowL, et al.The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity. Obes Surg2012;22:1771–82. 10.1007/s11695-012-0751-8 [PubMed: 22956251] [CrossRef]
- 99.
- ShaheenNJ, SharmaP, OverholtBF, WolfsenHC, SamplinerRE, WangKK, et al.Radiofrequency ablation in Barrett’s esophagus with dysplasia. N Engl J Med2009;360:2277–88. 10.1056/NEJMoa0808145 [PubMed: 19474425] [CrossRef]
- 100.
- ThompsonCC, ChandB, ChenYK, DeMarcoDC, MillerL, SchweitzerM, et al.Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology2013;145:129–37.e3. 10.1053/j.gastro.2013.04.002 [PubMed: 23567348] [CrossRef]
- 101.
- ToouliJ, Roberts-ThomsonIC, KellowJ, DowsettJ, SacconeGT, EvansP, et al.Manometry based randomised trial of endoscopic sphincterotomy for sphincter of Oddi dysfunction. Gut2000;46:98–102. 10.1136/gut.46.1.98 [PMC free article: PMC1727795] [PubMed: 10601063] [CrossRef]
- 102.
- van SchieCH, WhalleyA, VileikyteL, WignallT, HollisS, BoultonAJ. Efficacy of injected liquid silicone in the diabetic foot to reduce risk factors for ulceration: a randomized double-blind placebo-controlled trial. Diabetes Care2000;23:634–8. 10.2337/diacare.23.5.634 [PubMed: 10834422] [CrossRef]
- 103.
- VerheyeS, JolicœurEM, BehanMW, PetterssonT, SainsburyP, HillJ, et al.Efficacy of a device to narrow the coronary sinus in refractory angina. N Engl J Med2015;372:519–27. 10.1056/NEJMoa1402556 [PMC free article: PMC6647842] [PubMed: 25651246] [CrossRef]
- 104.
- WoodDE, NaderDA, SpringmeyerSC, ElstadMR, CoxsonHO, ChanA, et al.The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol2014;21:288–97. 10.1097/LBR.0000000000000110 [PubMed: 25321447] [CrossRef]
- 105.
- SwainCP, BownSG, StoreyDW, KirkhamJS, NorthfieldTC, SalmonPR. Controlled trial of argon laser photocoagulation in bleeding peptic ulcers. Lancet1981;2:1313–16. 10.1016/S0140-6736(81)91340-4 [PubMed: 6118717] [CrossRef]
- 106.
- BradleyJD, HeilmanDK, KatzBP, GsellP, WallickJE, BrandtKD. Tidal irrigation as treatment for knee osteoarthritis: a sham-controlled, randomized, double-blinded evaluation. Arthritis Rheum2002;46:100–8. 10.1002/1529-0131(200201)46:1<100::aid-art10037>3.0.co;2-v [PubMed: 11817581] [CrossRef]
- 107.
- FockensP, CohenL, EdmundowiczSA, BinmoellerK, RothsteinRI, SmithD, et al.Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease. Surg Endosc2010;24:1387–97. 10.1007/s00464-009-0784-9 [PMC free article: PMC2869435] [PubMed: 20198491] [CrossRef]
- 108.
- FullartonGM, BirnieGG, MacdonaldA, MurrayWR. Controlled trial of heater probe treatment in bleeding peptic ulcers. Br J Surg1989;76:541–4. 10.1002/bjs.1800760606 [PubMed: 2667687] [CrossRef]
- 109.
- GeliebterA, MeltonPM, GageD, McCrayRS, HashimSA. Gastric balloon to treat obesity: a double-blind study in nondieting subjects. Am J Clin Nutr1990;51:584–8. 10.1093/ajcn/51.4.584 [PubMed: 2181857] [CrossRef]
- 110.
- KrejsGJ, LittleKH, WestergaardH, HamiltonJK, SpadyDK, PolterDE. Laser photocoagulation for the treatment of acute peptic-ulcer bleeding. A randomized controlled clinical trial. N Engl J Med1987;316:1618–21. 10.1056/NEJM198706253162602 [PubMed: 3295548] [CrossRef]
- 111.
- LindorKD, HughesRW, IlstrupDM, JensenMD. Intragastric balloons in comparison with standard therapy for obesity – a randomized, double-blind trial. Mayo Clin Proc1987;62:992–6. 10.1016/S0025-6196(12)65069-1 [PubMed: 3312857] [CrossRef]
- 112.
- Mathus-VliegenEM, TytgatGN, Veldhuyzen-OffermansEA. Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon. Gastroenterology1990;99:362–9. 10.1016/0016-5085(90)91017-Z [PubMed: 2194894] [CrossRef]
- 113.
- O’BrienJD, DaySJ, BurnhamWR. Controlled trial of small bipolar probe in bleeding peptic ulcers. Lancet1986;1:464–7. 10.1016/S0140-6736(86)92928-4 [PubMed: 2869208] [CrossRef]
- 114.
- SilverbergGD, MayoM, SaulT, FellmannJ, CarvalhoJ, McGuireD. Continuous CSF drainage in AD: results of a double-blind, randomized, placebo-controlled study. Neurology2008;71:202–9. 10.1212/01.wnl.0000316197.04157.6f [PubMed: 18525029] [CrossRef]
- 115.
- VallonAG, CottonPB, LaurenceBH, Armengol MiroJR, Salord OsesJC. Randomised trial of endoscopic argon laser photocoagulation in bleeding peptic ulcers. Gut1981;22:228–33. 10.1136/gut.22.3.228 [PMC free article: PMC1419500] [PubMed: 7014392] [CrossRef]
- 116.
- FreitasD, DonatoA, MonteiroJG. Controlled trial of liquid monopolar electrocoagulation in bleeding peptic ulcers. Am J Gastroenterol1985;80:853–7. [PubMed: 3901730]
- 117.
- HolmlundT, Levring-JäghagenE, FranklinKA, LindkvistM, BerggrenD. Effects of Radiofrequency versus sham surgery of the soft palate on daytime sleepiness. Laryngoscope2014;124:2422–6. 10.1002/lary.24580 [PubMed: 24390800] [CrossRef]
- 118.
- LaineL. Multipolar electrocoagulation in the treatment of active upper gastrointestinal tract hemorrhage. A prospective controlled trial. N Engl J Med1987;316:1613–17. 10.1056/NEJM198706253162601 [PubMed: 3295547] [CrossRef]
- 119.
- MeshkinpourH, HsuD, FarivarS. Effect of gastric bubble as a weight reduction device: a controlled, crossover study. Gastroenterology1988;95:589–92. 10.1016/S0016-5085(88)80002-7 [PubMed: 3294080] [CrossRef]
- 120.
- SwainCP, KirkhamJS, SalmonPR, BownSG, NorthfieldTC. Controlled trial of Nd-YAG laser photocoagulation in bleeding peptic ulcers. Lancet1986;1:1113–17. 10.1016/S0140-6736(86)91835-0 [PubMed: 2871378] [CrossRef]
- 121.
- DaveyC, ZoumotZ, JordanS, McNultyWH, CarrDH, HindMD, et al.Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet2015;386:1066–73. 10.1016/S0140-6736(15)60001-0 [PubMed: 26116485] [CrossRef]
- 122.
- HunterJG, KahrilasPJ, BellRC, WilsonEB, TradKS, DolanJP, et al.Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology2015;148:324–33.e5. 10.1053/j.gastro.2014.10.009 [PubMed: 25448925] [CrossRef]
- 123.
- MatacheBA, BerduscoR, MomoliF, LapnerPL, PollockJW. A randomized, double-blind sham-controlled trial on the efficacy of arthroscopic tennis elbow release for the management of chronic lateral epicondylitis. BMC Musculoskelet Disord2016;17:239. 10.1186/s12891-016-1093-9 [PMC free article: PMC4888299] [PubMed: 27245219] [CrossRef]
- 124.
- NinaneV, GeltnerC, BezziM, FoccoliP, GottliebJ, WelteT, et al.Multicentre European study for the treatment of advanced emphysema with bronchial valves. Eur Respir J2012;39:1319–25. 10.1183/09031936.00019711 [PubMed: 22654006] [CrossRef]
- 125.
- PonceJ, WoodmanG, SwainJ, WilsonE, EnglishW, IkramuddinS, et al.The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis2015;11:874–81. 10.1016/j.soard.2014.12.006 [PubMed: 25868829] [CrossRef]
- 126.
- Soylu ÖzlerG. Silver nitrate cauterization: a treatment option for aphthous stomatitis. J Craniomaxillofac Surg2014;42:e281–3. 10.1016/j.jcms.2013.10.006 [PubMed: 24275482] [CrossRef]
- 127.
- WangS, LuJ, LiYA, ZhouH, NiWF, ZhangXL, et al.Autologous olfactory lamina propria transplantation for chronic spinal cord injury: three-year follow-up outcomes from a prospective double-blinded clinical trial. Cell Transplant2016;25:141–57. 10.3727/096368915X688065 [PubMed: 25924918] [CrossRef]
- 128.
- WeiJT, NygaardI, RichterHE, NagerCW, BarberMD, KentonK, et al.A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med2012;366:2358–67. 10.1056/NEJMoa1111967 [PMC free article: PMC3433843] [PubMed: 22716974] [CrossRef]
- 129.
- BackLJ, LiukkoT, RantanenI, et al.Radiofrequency surgery of the soft palate in the treatment of mild obstructive sleep apnea is not effective as a single-stage procedure: a randomized single-blinded placebo-controlled trial. Laryngoscope2009;119:1621–7. 10.1002/lary.20562 [PubMed: 19504550] [CrossRef]
- 130.
- DawesPT, KirlewC, HaslockI. Saline washout for knee osteoarthritis: results of a controlled study. Clin Rheumatol1987;6:61–3. 10.1007/BF02201002 [PubMed: 3581699] [CrossRef]
- 131.
- DimondEG, KittleCF, CrockettJE. Comparison of internal mammary artery ligation and sham operation for angina pectoris. Am J Cardiol1960;5:483–6. 10.1016/0002-9149(60)90105-3 [PubMed: 13816818] [CrossRef]
- 132.
- GillespieMB, WyliePE, Lee-ChiongT, RapoportDM. Effect of palatal implants on continuous positive airway pressure and compliance. Otolaryngol Head Neck Surg2011;144:230–6. 10.1177/0194599810392173 [PubMed: 21493422] [CrossRef]
- 133.
- HarjuT, KivekäsI, NumminenJ, RautiainenM. The effect of inferior turbinate surgery on ear symptoms. Laryngoscope2018;128:568–72. 10.1002/lary.26823 [PubMed: 28833181] [CrossRef]
- 134.
- KalunianKC, MorelandLW, KlashmanDJ, BrionPH, ConcoffAL, MyersS, et al.Visually-guided irrigation in patients with early knee osteoarthritis: a multicenter randomized, controlled trial. Osteoarthritis Cartilage2000;8:412–18. 10.1053/joca.1999.0316 [PubMed: 11069725] [CrossRef]
- 135.
- ScolapioJS, GostoutCJ, SchroederKW, et al.Dysphagia without endoscopically evident disease: to dilate or not?Am J Gastroenterol2001;96:327–30. 10.1111/j.1572-0241.2001.03514.x [PubMed: 11232671] [CrossRef]
- 136.
- GrossRE, WattsRL, HauserRA, BakayRA, ReichmannH, von KummerR, et al.Intrastriatal transplantation of microcarrier-bound human retinal pigment epithelial cells versus sham surgery in patients with advanced Parkinson’s disease: a double-blind, randomised, controlled trial. Lancet Neurol2011;10:509–19. 10.1016/S1474-4422(11)70097-7 [PubMed: 21565557] [CrossRef]
- 137.
- KernohanRM, AndersonJR, McKelveyST, KennedyTL. A controlled trial of bipolar electrocoagulation in patients with upper gastrointestinal bleeding. Br J Surg1984;71:889–91. 10.1002/bjs.1800711128 [PubMed: 6388722] [CrossRef]
- 138.
- MaurerJT, SommerJU, HeinG, HörmannK, HeiserC, StuckBA. Palatal implants in the treatment of obstructive sleep apnea: a randomised, placebo-controlled single-centre trial. Eur Arch Otorhinolaryngol2012;269:1851–6. 10.1007/s00405-011-1920-4 [PubMed: 22228439] [CrossRef]
- 139.
- HeySP, WeijerC. What questions can a placebo answer?Monash Bioeth Rev2016;34:23–36. 10.1007/s40592-016-0057-z [PubMed: 27188301] [CrossRef]
- 140.
- RothmanDJ. Strangers At The Bedside: A History Of How Law And Bioethics Transformed Medical Decision Making. New York, NY: Basic Books; 1992.
- 141.
- HorngS, MillerFG. Is placebo surgery unethical?N Engl J Med2002;347:137–9. 10.1056/NEJMsb021025 [PubMed: 12110744] [CrossRef]
- 142.
- KimSY, FrankS, HollowayR, ZimmermanC, WilsonR, KieburtzK. Science and ethics of sham surgery: a survey of Parkinson disease clinical researchers. Arch Neurol2005;62:1357–60. 10.1001/archneur.62.9.1357 [PubMed: 16157742] [CrossRef]
- 143.
- KimSY, De VriesR, HollowayRG, WilsonR, ParnamiS, KimHM, et al.Sham surgery controls in Parkinson’s disease clinical trials: views of participants. Mov Disord2012;27:1461–5. 10.1002/mds.25155 [PMC free article: PMC3703438] [PubMed: 22927064] [CrossRef]
- 144.
- FrankSA, WilsonR, HollowayRG, ZimmermanC, PetersonDR, KieburtzK, KimSY. Ethics of sham surgery: perspective of patients. Mov Disord2008;23:63–8. 10.1002/mds.21775 [PubMed: 17960809] [CrossRef]
- 145.
- SwiftTL. Sham surgery trial controls: perspectives of patients and their relatives. J Empir Res Hum Res Ethics2012;7:15–28. 10.1525/jer.2012.7.3.15 [PMC free article: PMC3526366] [PubMed: 22850140] [CrossRef]
- 146.
- National Commission for the Protection of Human Subject of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Bethesda, MD: National Commission for the Protection of Human Subject of Biomedical and Behavioral Research; 1978. [PubMed: 25951677]
- 147.
- WeijerC, MillerPB. When are research risks reasonable in relation to anticipated benefits?Nat Med2004;10:570–3. 10.1038/nm0604-570 [PubMed: 15170195] [CrossRef]
- 148.
- FreedmanB. Equipoise and the ethics of clinical research. N Engl J Med1987;317:141–5. 10.1056/NEJM198707163170304 [PubMed: 3600702] [CrossRef]
- 149.
- WeijerC. I need a placebo like I need a hole in the head. J Law Med Ethics2002;30:69–72. 10.1111/j.1748-720x.2002.tb00721.x [PubMed: 11905271] [CrossRef]
- 150.
- HurstSA. Vulnerability in research and health care; describing the elephant in the room?Bioethics2008;22:191–202. 10.1111/j.1467-8519.2008.00631.x [PubMed: 18405317] [CrossRef]
- 151.
- AppelbaumPS, GrissoT. Assessing patients’ capacities to consent to treatment. N Engl J Med1988;319:1635–8. 10.1056/NEJM198812223192504 [PubMed: 3200278] [CrossRef]
- 152.
- NishimuraA, CareyJ, ErwinPJ, TilburtJC, MuradMH, McCormickJB. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics2013;14:28. 10.1186/1472-6939-14-28 [PMC free article: PMC3733934] [PubMed: 23879694] [CrossRef]
- 153.
- PaavolaM, MalmivaaraA, TaimelaS, KantoK, InkinenJ, KalskeJ, et al.Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial. BMJ2018;362:k2860. 10.1136/bmj.k2860 [PMC free article: PMC6052435] [PubMed: 30026230] [CrossRef]
- 154.
- AndersonDB, FerreiraML, HarrisIA, DavisGA, StanfordR, BeardD, et al.SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomised, placebo-controlled trial. BMJ Open2019;9:e024944. 10.1136/bmjopen-2018-024944 [PMC free article: PMC6398750] [PubMed: 30765407] [CrossRef]
- 155.
- SchulzKF, GrimesDA. Multiplicity in randomised trials II: subgroup and interim analyses. Lancet2005;365:1657–61. 10.1016/S0140-6736(05)66516-6 [PubMed: 15885299] [CrossRef]
- 156.
- World Medical Association. WMA Declaration of Helsinki – Ethical Principles For Medical Research Involving Human Subjects. Ferney-Voltaire: World Medical Association; 2018.
- 157.
- GilliesK, DuthieA, CottonS, CampbellMK. Patient reported measures of informed consent for clinical trials: a systematic review. PLOS ONE2018;13:e0199775. 10.1371/journal.pone.0199775 [PMC free article: PMC6021104] [PubMed: 29949627] [CrossRef]
- 158.
- European Medicines Agency. ICH Topic E 6 (R1) Guideline for Good Clinical Practice. URL: www
.ema.europa.eu/en /documents/scientific-guideline /ich-e6-r1-guideline-good-clinical-practice_en .pdf (accessed 7 July 2021). - 159.
- Food and Drug Administration. A Guide to Informed Consent. URL: www
.fda.gov/regulatory-information /search-fda-guidance-documents /guide-informed-consent (accessed 7 July 2021). - 160.
- InnesK, CottonS, CampbellMK, ElliottJ, GilliesK. Relative importance of informational items in participant information leaflets for trials: a Q-methodology approach. BMJ Open2018;8:e023303. 10.1136/bmjopen-2018-023303 [PMC free article: PMC6129101] [PubMed: 30185580] [CrossRef]
- 161.
- RogersW, HutchisonK, SkeaZC, CampbellMK. Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals. BMC Med Ethics2014;15:78. 10.1186/1472-6939-15-78 [PMC free article: PMC4223753] [PubMed: 25341496] [CrossRef]
- 162.
- HareKB, LohmanderLS, RoosEM. The challenge of recruiting patients into a placebo-controlled surgical trial. Trials2014;15:167. 10.1186/1745-6215-15-167 [PMC free article: PMC4030043] [PubMed: 24884948] [CrossRef]
- 163.
- HuangGD, BullJ, Johnston McKeeK, MahonE, HarperB, RobertsJN, CTTI Recruitment Project Team. Clinical trials recruitment planning: a proposed framework from the Clinical Trials Transformation Initiative. Contemp Clin Trials2018;66:74–9. 10.1016/j.cct.2018.01.003 [PubMed: 29330082] [CrossRef]
- 164.
- DonovanJL, RooshenasL, JepsonM, ElliottD, WadeJ, AveryK, et al.Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials2016;17:283. 10.1186/s13063-016-1391-4 [PMC free article: PMC4898358] [PubMed: 27278130] [CrossRef]
- 165.
- ColwellB, MathersN, NgCJ, BradleyA. Improving recruitment to primary care trials: some lessons from the use of modern marketing techniques. Br J Gen Pract2012;62:496–8. 10.3399/bjgp12X654759 [PMC free article: PMC3426594] [PubMed: 22947576] [CrossRef]
- 166.
- McDonaldAM, TreweekS, ShakurH, FreeC, KnightR, SpeedC, CampbellMK. Using a business model approach and marketing techniques for recruitment to clinical trials. Trials2011;12:74. 10.1186/1745-6215-12-74 [PMC free article: PMC3063210] [PubMed: 21396088] [CrossRef]
- 167.
- GalliL, KnightR, RobertsonS, HoileE, OladapoO, FrancisD, FreeC. Using marketing theory to inform strategies for recruitment: a recruitment optimisation model and the txt2stop experience. Trials2014;15:182. 10.1186/1745-6215-15-182 [PMC free article: PMC4057570] [PubMed: 24886627] [CrossRef]
- 168.
- TreweekS, PitkethlyM, CookJ, FraserC, MitchellE, SullivanF, et al.Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev2018;2:MR000013. 10.1002/14651858.MR000013.pub6 [PMC free article: PMC7078793] [PubMed: 29468635] [CrossRef]
- 169.
- TownsendD, MillsN, SavovićJ, DonovanJL. A systematic review of training programmes for recruiters to randomised controlled trials. Trials2015;16:432. 10.1186/s13063-015-0908-6 [PMC free article: PMC4587840] [PubMed: 26416143] [CrossRef]
- 170.
- CookJA, McCullochP, BlazebyJM, BeardDJ, Marinac-DabicD, SedrakyanA, IDEAL Group. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ2013;346:f2820. 10.1136/bmj.f2820 [PMC free article: PMC3685513] [PubMed: 23778425] [CrossRef]
- 171.
- HamdyFC. The Prostate Testing for Cancer and Treatment (ProtecT) study: what have we learnt?BJU Int2016;118:843. 10.1111/bju.13699 [PubMed: 27870364] [CrossRef]
- 172.
- DonovanJL, PetersTJ, NobleS, PowellP, GillattD, OliverSE, et al.Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study). J Clin Epidemiol2003;56:605–9. 10.1016/S0895-4356(03)00083-0 [PubMed: 12921927] [CrossRef]
- 173.
- NHS England. Evidence-Based Interventions Programme.2020. URL: www
.england.nhs.uk/evidence-based-interventions /interventions/ (accessed 7 July 2021). - 174.
- Editorial. Gaining control: placebos in surgery trials. Lancet2020;395:756. 10.1016/S0140-6736(20)30524-9 [PubMed: 32145773] [CrossRef]
- References - Placebo comparator group selection and use in surgical trials: the ...References - Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop
- Theme 1: meeting the needs of the NHS - Clinical trial metadata: defining and ex...Theme 1: meeting the needs of the NHS - Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme
- Results - Behavioural interventions to promote physical activity in a multiethni...Results - Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT
- Economic evaluation - Patient-reported outcome measures for monitoring primary c...Economic evaluation - Patient-reported outcome measures for monitoring primary care patients with depression: the PROMDEP cluster RCT and economic evaluation
- The FEVER observational study - Different temperature thresholds for antipyretic...The FEVER observational study - Different temperature thresholds for antipyretic intervention in critically ill children with fever due to infection: the FEVER feasibility RCT
Your browsing activity is empty.
Activity recording is turned off.
See more...