Process evaluation in randomised controlled trials of complex interventions

Most randomised controlled trials focus on outcomes, not on the processes involved in implementing an intervention. Using an example from school based health promotion, this paper argues that including a process evaluation would improve the science of many randomised controlled trials

[1]  Judith M. Gueron,et al.  The politics of random assignment: implementing studies and impacting policy , 2008 .

[2]  Anne M Johnson,et al.  Integrating Process with Outcome Data in a Randomized Controlled Trial of Sex Education , 2006 .

[3]  L. Hirsch.  Competing interests: none declared. , 2006 .

[4]  M. Mugford,et al.  The impact of day care on socially disadvantaged families: an example of the use of process evaluation within a randomized controlled trial. , 2004, Child: Care, Health and Development.

[5]  R Power,et al.  Developing complex interventions for rigorous evaluation--a case study from rural Zimbabwe. , 2004, Health education research.

[6]  A. Oakley,et al.  Evaluating Processes , 2004 .

[7]  Alan Shiell,et al.  Methods for exploring implementation variation and local context within a cluster randomised community intervention trial , 2004, Journal of Epidemiology and Community Health.

[8]  M. Mugford,et al.  The Social Support and Family Health Study: a randomised controlled trial and economic evaluation of two alternative forms of postnatal support for mothers living in disadvantaged inner-city areas. , 2004, Health technology assessment.

[9]  Anne M Johnson,et al.  Pupil-led sex education in England (RIPPLE study): cluster-randomised intervention trial , 2004, The Lancet.

[10]  Alan Shiell,et al.  Complex interventions: how “out of control” can a randomised controlled trial be? , 2004, BMJ : British Medical Journal.

[11]  A. Oakley,et al.  A school-based randomized controlled trial of peer-led sex education in England. , 2003, Controlled clinical trials.

[12]  D. Wight,et al.  The role of randomized controlled trials in assessing sexual health interventions , 2003 .

[13]  J. Stephenson,et al.  Effective Sexual Health Interventions: Issues in Experimental Evaluation , 2003 .

[14]  D. Wight,et al.  Unpacking the black box: the importance of process data to explain outcomes , 2003 .

[15]  M. Hotopf.  The pragmatic randomised controlled trial , 2002 .

[16]  J Elford,et al.  Peer-led HIV prevention among gay men in London: Process evaluation , 2002, AIDS care.

[17]  M. Frommer,et al.  Criteria for evaluating evidence on public health interventions , 2002, Journal of epidemiology and community health.

[18]  F. Mosteller,et al.  Evidence matters : randomized trials in education research , 2002 .

[19]  Sandy Oliver,et al.  Peer-delivered health promotion for young people: A systematic review of different study designs , 2001 .

[20]  N. Wolff,et al.  Randomised trials of socially complex interventions: promise or peril? , 2001, Journal of health services research & policy.

[21]  P. Sandercock,et al.  Framework for design and evaluation of complex interventions to improve health , 2000, BMJ : British Medical Journal.

[22]  S. Going,et al.  Process evaluation in a multisite, primary obesity-prevention trial in American Indian schoolchildren. , 1999, The American journal of clinical nutrition.

[23]  D. Mant,et al.  Development and evaluation of complex interventions in health services research: case study of the Southampton heart integrated care project (SHIP) , 1999 .

[24]  A. Oakley,et al.  Behavioural intervention trials for HIV/STD prevention in schools: are they feasible? , 1998, Sexually transmitted infections.

[25]  S. Huttly,et al.  The role of conceptual frameworks in epidemiological analysis: a hierarchical approach. , 1997, International journal of epidemiology.

[26]  G H Guyatt,et al.  A Consumer's Guide to Subgroup Analyses , 1992, Annals of Internal Medicine.

[27]  R. Coughlin,et al.  Does It Work , 1978 .