title: How the psychosocial context of clinical trials differs from usual care: a qualitative study of acupuncture patients.
abstract: BACKGROUND
  Qualitative studies of participants' experiences in randomised clinical trials (RCTs) suggest that the psychosocial context of treatment in RCTs may be quite different to the psychosocial context of treatment in usual practice. This is important, as the psychosocial context of treatment is known to influence patient outcomes in chronic illness. Few studies have directly compared the psychosocial context of treatment across RCTs and usual practice. In this study, we explored differences in psychosocial context between RCT and usual practice settings, using acupuncture as our model.
  
  
  METHODS
  We undertook a secondary analysis of existing qualitative interviews with 54 patients. 27 were drawn from a study of western and traditional acupuncture in usual practice (for a range of painful conditions). 27 were drawn from a qualitative study nested in an RCT of western acupuncture for osteoarthritis of the hip or knee. We used qualitative analysis software to facilitate an inductive thematic analysis in which we identified three main themes.
  
  
  RESULTS
  In usual practice, starting acupuncture was more likely to be embedded in an active and ongoing search for pain relief, whereas in the RCT starting acupuncture was opportunistic. Usual practice patients reported few uncertainties and these had minimal consequences for them. In the RCT, patients experienced considerable uncertainties about their treatment and its effectiveness, and were particularly concerned about whether they were receiving real (or fake) acupuncture. Patients stopped acupuncture only at the end of the fixed course of treatment in the RCT, which was similar to those receiving acupuncture in the public sector National Health Service (NHS). In comparison, private sector patients re-evaluated and re-negotiated treatments particularly when starting to use acupuncture.
  
  
  CONCLUSIONS
  Differences in psychosocial context between RCTs and usual practice could reduce the impact of acupuncture in RCT settings and/or lead to under-reporting of benefit by patients in trials. New trial designs that ensure participants' experiences are similar to usual practice should minimise differences in psychosocial context and help attenuate these potentially confounding effects.
authors: Health Experiences Research Group, Department of Primary Health Care, University of Oxford, Old Road Campus, Headington, Oxford, UK.
authors: Fiona
authors: F
authors: Barlow
authors: Clare
authors: C
authors: Scott
authors: Beverly
authors: B
authors: Coghlan
authors: Philippa
authors: P
authors: Lee
authors: Peter
authors: P
authors: White
authors: George T
authors: GT
authors: Lewith
authors: Felicity L
authors: FL
authors: Bishop
references: Cult Med Psychiatry. 2009 Sep;33(3):382-411
references: 19597976
references: BMJ. 1998 Nov 7;317(7168):1301
references: 9804722
references: Complement Ther Med. 2008 Apr;16(2):101-6
references: 18514912
references: J Altern Complement Med. 2010 Feb;16(2):175-82
references: 20180690
references: J Health Psychol. 2001 May;6(3):269-82
references: 22049373
references: J Altern Complement Med. 2011 Jan;17(1):19-25
references: 21235412
references: Complement Ther Med. 2001 Mar;9(1):2-11
references: 11264963
references: Lancet. 2001 Mar 10;357(9258):757-62
references: 11253970
references: BMJ. 1998 Jan 17;316(7126):201
references: 9468688
references: N Engl J Med. 2000 Jun 22;342(25):1887-92
references: 10861325
references: BMJ. 1998 Oct 31;317(7167):1177-80
references: 9794849
references: Health Technol Assess. 1999;3(3):1-96
references: 10448203
references: Chronic Illn. 2008 Dec;4(4):264-77
references: 19091935
references: J Acupunct Meridian Stud. 2008 Sep;1(1):1-12
references: 20633449
references: J Eval Clin Pract. 2005 Feb;11(1):77-84
references: 15660541
references: Health Technol Assess. 2005 Mar;9(8):1-192, iii-iv
references: 15763039
references: Int J Nurs Stud. 2002 Sep;39(7):671-83
references: 12231024
references: J Altern Complement Med. 2006 Nov;12(9):873-80
references: 17109578
references: BMJ. 1998 Jan 24;316(7127):285
references: 9472515
references: BMJ. 2005 May 21;330(7501):1202-5
references: 15905259
references: BMC Med Res Methodol. 2009 Jun 11;9:34
references: 19519887
references: Soc Sci Med. 1997 Nov;45(9):1337-55
references: 9351153
references: BMC Health Serv Res. 2011 May 27;11:129
references: 21619572
references: BMJ. 1998 Oct 31;317(7167):1185-90
references: 9794851
references: Qual Health Res. 1999 Sep;9(5):639-53
references: 10558372
references: J Altern Complement Med. 2004 Oct;10(5):791-801
references: 15650468
references: J Altern Complement Med. 2008 Mar;14(2):199-208
references: 18315508
references: JAMA. 2000 Sep 13;284(10):1290-6
references: 10979117
references: BMJ. 2010 Mar 19;340:c1066
references: 20304934
references: BMJ. 2008 May 3;336(7651):995-8
references: 18456631
references: Patient Educ Couns. 1999 Oct;38(2):131-42
references: 14528705