Process evaluation in randomised controlled trials of complex interventions.
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Biomedical subjects
Publications and source records attributed to Ann Oakley.
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Public health decision makers, funders, practitioners, and the public are increasingly interested in the evidence that underpins public health decision making. Decisions in public health cover a vast range of activities. With the ever increasing global volume of primary research, knowledge and changes in thinking and approaches, quality systematic reviews of all the available research that is relevant to a particular practice or policy decision are an efficient way to synthesise and utilise research efforts. The Cochrane Collaboration includes an organised entity that aims to increase the quality and quantity of public health systematic reviews, through a range of activities. This paper aims to provide a glossary of the terms and activities related to public health and the Cochrane Collaboration.
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Methods for systematic reviews are well developed for trials, but not for non-experimental or qualitative research. This paper describes the methods developed for reviewing research on people's perspectives and experiences ("views" studies) alongside trials within a series of reviews on young people's mental health, physical activity, and healthy eating. Reports of views studies were difficult to locate; could not easily be classified as "qualitative" or "quantitative"; and often failed to meet seven basic methodological reporting standards used in a newly developed quality assessment tool. Synthesising views studies required the adaptation of qualitative analysis techniques. The benefits of bringing together views studies in a systematic way included gaining a greater breadth of perspectives and a deeper understanding of public health issues from the point of view of those targeted by interventions. A systematic approach also aided reflection on study methods that may distort, misrepresent, or fail to pick up people's views. This methodology is likely to create greater opportunities for people's own perspectives and experiences to inform policies to promote their health.
OBJECTIVE: To assess the effects of providing daycare facilities for young children on the health and welfare of disadvantaged families. DESIGN: Randomised controlled trial. Eligible children from the application list to a daycare facility were randomly allocated to receive a daycare place or not. SETTING: Early Years daycare centre in Borough of Hackney, London. PARTICIPANTS: 120 mothers and 143 eligible children (aged between 6 months and 3.5 years). INTERVENTION: A place at the centre, which provided high quality day care. Control families used other child care that they secured for themselves. MAIN OUTCOME MEASURES: Maternal paid employment, household income, child health and development. RESULTS: At 18 months' follow up, 67% of intervention group mothers and 60% of control group mothers were in paid employment (adjusted risk ratio 1.23 (95% confidence interval 0.99 to 1.52)), but were no more likely to have a weekly household income of above pound 200 (risk ratio 0.88 (0.70 to 1.09)). Intervention group children had more otitis media with effusion (risk ratio 1.74 (1.02 to 2.96)) and used more health services (1.58 (1.05 to 2.38)), but both estimates were imprecise. CONCLUSION: The provision of child day care may have increased maternal employment, but it did not seem to increase household income. The results suggest that providing day care may be insufficient as a strategy to reduce poverty. The study shows how random allocation can be used to ration and evaluate interventions where demand exceeds supply.
OBJECTIVES: To describe the recruitment procedures used in a study of Social Support and Family Health carried out in a disadvantaged urban area of the UK in 1999-2001; to consider the impact of using inclusive recruitment procedures on the final research sample and implications for the conduct of the research and data obtained. DESIGN: Face-to-face recruitment of eligible women, using interpreters where necessary, to a randomized controlled trial of two alternative strategies for providing support to women with infants. RESULTS: Of the 1,263 women eligible to enter the trial, 731 were successfully recruited. Forty-five languages other than English were spoken by eligible women; 14% needed an interpreter for the recruitment visit, and a further 30% spoke English as a second language. Inclusive recruitment practices added significant costs, resulted in a study sample with a different social profile from the sample that would have been achieved without these, and challenged some of the assumptions underlying the model of informed consent commonly used in much health services research. CONCLUSION: Procedures can be developed for recruiting people with diverse cultural backgrounds to take part in research. This helps to address the issue of possible bias in generalizing research findings by increasing external validity, and respects the ethic that everyone should have the right to be eligible for inclusion in research.
The RIPPLE study is a randomized controlled trial of peer-led sex education in English secondary schools. In 1997, 27 schools were recruited and randomly allocated to a programme of peer-led sex education or to act as control schools. In experimental schools peer educators in Year 12 (aged 16/17 years) were recruited in two successive cohorts and, having received a standardized training programme, delivered classroom-based sex education sessions to Year 9 students (aged 13/14 years). This paper is the first of two focusing on data gathered from these peer educators. Through analysis of pre-(n = 505) and post- (n = 331) programme questionnaire data, the paper describes the profile of peer educators and examines the impact on them of their involvement. Compared to the students receiving the peer-led sex education, more peer educators were female, white, high academic achievers and less socially disadvantaged. Peer educators reported positive changes in sexual knowledge and changes towards more liberal attitudes, and believed the programme would have a positive impact on their confidence in relationships and on their sexual behaviour. There was an increase in confidence about communication and interaction in groups. The paper discusses the methodological difficulties of assessing how involvement in such a programme impacts on peer educators.
This paper is the second of two presenting data gathered from peer educators in the RIPPLE study-a randomized controlled trial of peer-led sex education in English secondary schools. Peer educators were recruited from Year 12 students (aged 16/17 years) in 13 schools in two successive cohorts in 1997 and 1998. Following a standardized training programme they delivered sex education sessions to Year 9 students (aged 13/14 years). Through analysis of 18 focus group discussions and of post-programme questionnaire data (n = 301), this paper aims to identify the issues and processes considered by peer educators to be important in implementing a peer education programme, and to examine peer educators' views on the relationship between themselves and the Year 9 students. Methodological issues arising when collecting, analysing and presenting such data are discussed, and some recommendations are outlined for carrying out school-based peer education.
This study describes the characteristics of clients referred to two UK parent support initiatives - Newpin and Home-Start - and documents key aspects of the referral process and clients' responses to the help provided. Data were collected from referral records on 214 families referred during 1992 to four Newpin centres and 349 families referred between April 1994 and March 1995 to four Home-Start schemes. Families were sent questionnaires. Qualitative interview data were collected from a sub-sample of families and from staff and referrers in the Newpin study; volunteers and referrers completed questionnaires in the Home-Start study. Socially disadvantaged families were less likely to return the study questionnaires. The kinds of families and problems referred to the two organizations were very similar. Mothers' loneliness and low emotional well-being were the main reasons for referral; children at risk represented a small part of the caseload. Both Newpin and Home-Start respondents had low levels of support from family and friends. Most referrals were made by health visitors, and there was a significant problem of non use among referred families. Most users of Newpin and Home-Start were enthusiastic about the help provided. Common difficulties in family life, such as poverty, stress and low social support, make up an increasing part of the workload of health professionals and social workers, and of voluntary sector initiatives for supporting parents. This study raises questions about the claims such initiatives may make about their effectiveness in reaching and providing help to 'at risk' families. Further evaluation of such schemes is needed to provide a sound evidence-base for policy and purchasing decisions.
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