Josephine Kavanagh

Integrating qualitative research with trials in systematic reviews

An example review from public health shows how integration is possible and some potential benefits The value of including data from different types of studies in systematic reviews of health interventions is increasingly recognised. A recent editorial accepted that qualitative research should be included in systematic reviews, but pointed to a “daunting array of theoretical and practical problems.”1 This article presents an approach to combining qualitative and quantitative research in a systematic review. We describe how we used this approach in a systematic review of interventions to promote healthy eating among children, full details of which are available.2 The review question was: “What is known about the barriers to, and facilitators of, healthy eating among children aged 4-10 years?” The specific focus of the review was fruit and vegetable intake. We searched for two types of research: controlled trials (randomised or non-randomised) that examined interventions to promote healthy eating and studies that examined childrens perspectives and understandings (views studies), often by using qualitative research methods—for example, in-depth interviews and focus groups. ![][1] But will she eat her greens? Credit: PAUL DARRAH/REX We used conventional systematic review methods: sensitive searching, systematic screening, and independent quality assessment. These methods found 33 trials and eight qualitative studies that met our prespecified inclusion criteria. We assessed studies for quality and reliability according to standards for their specific study types; they were then synthesised individually by using methods appropriate to the study. We conducted a meta-analysis with the data extracted from trials, used qualitative methods to synthesise the textual data extracted from the qualitative studies, and then integrated the findings from the qualitative synthesis with those from the meta-analysis. This gave us one review with three syntheses (fig 1). Fig 1 Stages of the review We maintained the key principles of avoiding bias and maximising … [1]: /embed/graphic-1.gif

The effectiveness and cost-effectiveness of behavioural interventions for the prevention of sexually transmitted infections in young people aged 13-19: a systematic review and economic evaluation

OBJECTIVES To assess the effectiveness and cost-effectiveness of schools-based skills-building behavioural interventions to encourage young people to adopt and maintain safer sexual behaviour and to prevent them from acquiring sexually transmitted infections (STIs). DATA SOURCES Electronic bibliographic databases (e.g. MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, CINAHL, PsycINFO, CCRCT, NHS EED and DARE) were searched for the period 1985 to March 2008. Bibliographies of systematic reviews and related papers were screened and experts contacted to identify additional published and unpublished references. REVIEW METHODS A systematic review of effectiveness and economic evaluation of cost-effectiveness were carried out. A descriptive map of studies that met inclusion criteria was produced, and keywords were developed and systematically applied to these studies to identify a policy-relevant subset of studies for the systematic review. Outcome data for variables including sexual behaviour were extracted. An economic model was developed to compare the costs and consequences of the behavioural interventions. A Bernoulli statistical model was constructed to describe the probability of STI infection. RESULTS There were few significant differences between the interventions and comparators in terms of changes in sexual behaviour outcomes, although there were some significant differences for knowledge and some measures of self-efficacy. The studies included in this review conducted relatively short follow-up assessments at a time when many young people were becoming sexually active. It is therefore possible that favourable behaviour change may have occurred, and become more cost-effective, with time, as sexual activity becomes more routine in young peoples lives. The quality of the intervention provider influenced whether or not young people found the interventions to be acceptable and engaging; enthusiasm and considerable expertise were important for effective class management and delivery of skills-building activities, and a supportive school culture was also helpful. Recognition of young peoples individual needs in relation to sexual health was another important factor. No conclusions could be drawn on the impact of the interventions on sexual health inequalities due to a lack of relevant data on socioeconomic status, gender and ethnicity. The results of the economic evaluation were considered to be illustrative, mainly due to the uncertainty of the effect of intervention on behavioural outcomes. The results were most sensitive to changes in parameter values for the intervention effect, the transmission probability of STIs and the number of sexual partners. The costs of teacher-led and peer-led behavioural interventions, based on the resources estimated from the relevant randomised controlled trials in our systematic review, were 4.30 pounds and 15 pounds per pupil, respectively. Teacher-led interventions were more cost-effective than peer-led interventions due to the less frequent need for training. The incremental cost-effectiveness of the teacher-led and peer-led interventions was 20,223 pounds and 80,782 pounds per quality-adjusted life-year gained, respectively. An analysis of individual parameters revealed that future research funding should focus on assessing the intervention effect for condom use from a school-based intervention. CONCLUSIONS School-based behavioural interventions for the prevention of STIs in young people can bring about improvements in knowledge and increased self-efficacy, but the interventions did not significantly influence sexual risk-taking behaviour or infection rates. Future investigation should include long-term follow-up to assess the extent to which safer sexual behaviour is adopted and maintained into adulthood, and prospective cohort studies are needed to look at the parameters that describe the transmission of STIs between partners. Funding should focus on the effectiveness of the interventions on influencing behaviour.

School-based cognitive-behavioural interventions: A systematic review of effects and inequalities

Abstract Little is known about the impact of preventive interventions on inequalities in young people’s mental health. We conducted a systematic review of mental health promotion interventions based on cognitive behavioural therapy (CBT) delivered in schools to young people aged 11–19. Meta-analysis of 17 high quality randomised controlled trials (RCTs) showed a reduction in symptoms of depression, which was generally short term. Interventions for people with clinical risk factors or existing symptoms were more effective, with benefits lasting up to six months. We also found that CBT may be more effective for young people from families with middle to high socioeconomic status (SES) than for those from low SES backgrounds. However, this finding was based on a metaregression with only six studies. A lack of long-term follow-up data and a failure to report subgroup analyses prevented further conclusions being drawn about the effect of these types of interventions on mental health inequalities.

The effectiveness of community engagement in public health interventions for disadvantaged groups: a meta-analysis

BackgroundInequalities in health are acknowledged in many developed countries, whereby disadvantaged groups systematically suffer from worse health outcomes such as lower life expectancy than non-disadvantaged groups. Engaging members of disadvantaged communities in public health initiatives has been suggested as a way to reduce health inequities. This systematic review was conducted to evaluate the effectiveness of public health interventions that engage the community on a range of health outcomes across diverse health issues.MethodsWe searched the following sources for systematic reviews of public health interventions: Cochrane CDSR and CENTRAL, Campbell Library, DARE, NIHR HTA programme website, HTA database, and DoPHER. Through the identified reviews, we collated a database of primary studies that appeared to be relevant, and screened the full-text documents of those primary studies against our inclusion criteria. In parallel, we searched the NHS EED and TRoPHI databases for additional primary studies. For the purposes of these analyses, study design was limited to randomised and non-randomised controlled trials. Only interventions conducted in OECD countries and published since 1990 were included. We conducted a random effects meta-analysis of health behaviour, health consequences, self-efficacy, and social support outcomes, and a narrative summary of community outcomes. We tested a range of moderator variables, with a particular emphasis on the model of community engagement used as a potential moderator of intervention effectiveness.ResultsOf the 9,467 primary studies scanned, we identified 131 for inclusion in the meta-analysis. The overall effect size for health behaviour outcomes is d = .33 (95% CI .26, .40). The interventions were also effective in increasing health consequences (d = .16, 95% CI .06, .27); health behaviour self-efficacy (d = .41, 95% CI .16, .65) and perceived social support (d = .41, 95% CI .23, .65). Although the type of community engagement was not a significant moderator of effect, we identified some trends across studies.ConclusionsThere is solid evidence that community engagement interventions have a positive impact on a range of health outcomes across various conditions. There is insufficient evidence to determine whether one particular model of community engagement is more effective than any other.

Dinoprostone vaginal insert for cervical ripening and labor induction: a meta-analysis.

Objective To compare dinoprostone 10 mg controlled-release vaginal insert with other forms of vaginal or cervical prostaglandin for cervical ripening. Data Sources Literature search strategy included review of the Cochrane database of randomized trials, on-line searching of MEDLINE, hand searching of bibliographies, and contact with authors of relevant reports. Methods of Study Selection Randomized trials were included if they compared a dinoprostone slow-release vaginal insert with an alternative vaginal or cervical prostaglandin for cervical ripening and labor induction in women at term with singleton gestations. Primary end points were delivery by 24 hours postinsertion, uterine hypertonus with fetal heart change, and cesarean delivery rate. Study inclusion, validity assessment, and data extraction were carried out independently by two reviewers, and cross-checked for consistency. Data were combined when appropriate, using the Mantel–Haenszel fixed-effects method. Statistical heterogeneity was assessed using chi-square statistics. Tabulation, Integration, and Results Nine relevant trials were identified, seven comparing the dinoprostone 10 mg vaginal insert with dinoprostone gel and two with misoprostol. Five trials reported adequate methods for randomization concealment. None were double blind. The likelihood of delivery by 24 hours was similar with the vaginal insert and alternatives: common odds ratio (OR) 0.80 (95% confidence interval [CI] 0.56, 1.15). Uterine hypertonus with change in fetal heart and cesarean delivery rate were also similar: common OR 1.19 (95% CI 0.56, 2.54) and 0.78 (95% CI 0.56, 1.08), respectively. The secondary end points of mean time to delivery and delivery by 12 hours appeared to favor misoprostol-dinoprostone gel. However, data for these end points were heterogeneous and their combination is therefore of limited value and potentially misleading. Conclusion No clinically significant differences were identified between the vaginal insert and alternatives used for cervical ripening at term.

The selection of search sources influences the findings of a systematic review of people’s views: a case study in public health

BackgroundFor systematic reviews providing evidence for policy decisions in specific geographical regions, there is a need to minimise regional bias when seeking out relevant research studies. Studies on people’s views tend to be dispersed across a range of bibliographic databases and other search sources. It is recognised that a comprehensive literature search can provide unique evidence not found from a focused search; however, the geographical focus of databases as a potential source of bias on the findings of a research review is less clear. This case study describes search source selection for research about people’s views and how supplementary searches designed to redress geographical bias influenced the findings of a systematic review. Our research questions are: a) what was the impact of search methods employed to redress potential database selection bias on the overall findings of the review? and b) how did each search source contribute to the identification of all the research studies included in the review?MethodsThe contribution of 25 search sources in locating 28 studies included within a systematic review on UK children’s views of body size, shape and weight was analysed retrospectively. The impact of utilising seven search sources chosen to identify UK-based literature on the review’s findings was assessed.ResultsOver a sixth (5 out of 28) of the studies were located only through supplementary searches of three sources. These five studies were of a disproportionally high quality compared with the other studies in the review. The retrieval of these studies added direction, detail and strength to the overall findings of the review. All studies in the review were located within 21 search sources. Precision for 21 sources ranged from 0.21% to 1.64%.ConclusionsFor reducing geographical bias and increasing the coverage and context-specificity of systematic reviews of people’s perspectives and experiences, searching that is sensitive and aimed at reducing geographical bias in database sources is recommended.

Psychosocial Predictors, Assessment, and Outcomes of Cosmetic Procedures: A Systematic Rapid Evidence Assessment

BackgroundRecent breast implant complications led to a UK government policy review of the evidence concerning cosmetic interventions. We synthesised cosmetic intervention research evidence covering psychosocial factors associated with requesting procedures and psychological outcomes, effects of procedures on psychological outcomes, preintervention assessments for identifying those at risk, alternative therapy effectiveness, and issues in achieving informed consent.MethodsUndertaking a systematic rapid evidence assessment, six databases and three journals were searched. Included studies were systematic reviews or primary studies of participants requesting cosmetic procedures; published 2002–2012; containing either psychological or psychosocial measures, a psychological outcome, or evaluation of informed consent. Reviewers independently assessed study eligibility, extracted data, and assessed quality, undertaking narrative synthesis.ResultsMethodological quality of the included 13 systematic reviews and 179 primary studies was low, with wide variation in psychosocial measures. Findings suggest several psychosocial factors (e.g., intimate partner violence) may be associated with requesting cosmetic surgery. Multiple factors (e.g., unrealistic expectations) may predict poor psychological outcomes. Current psychological screening tools focus predominantly on body dysmorphic disorder (BDD) symptoms. Psychological and pharmacological interventions are effective alternative BDD treatments. Patients and doctors bring different needs to informed consent discussions, inconsistently matched to those required by professional ethics, litigation risk, and facilitating profit.ConclusionsSystematically reviewing this literature for UK policy has highlighted that some groups may be at risk of poor post-cosmetic procedure outcomes. Practitioners and patients must explore reasons for seeking cosmetic procedures and discuss all potential results and alternative solutions. Future research should employ more robust methodologies to identify effects in those at risk, led by consensus on a core set of psychological outcomes.Level of Evidence IIIThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Are incentive schemes effective in changing young people's behaviour? A systematic review

Objective: To examine the impact of single or dual component incentive schemes on health and social behaviours, in young people. Design: A systematic review. Method: Systematic and comprehensive cross-disciplinary searches were conducted to identify research. Following screening for relevance, included studies were quality assessed and data extracted. Both outcome and process evaluation studies were included in either a statistical meta-analysis or narrative synthesis. Results: Sixteen trials and seven process evaluations were included in the review. There is some evidence to show that incentives are effective in improving single health behaviours, but not complex health behaviours. Incentives had no impact on levels of reported effort, or attendance in education studies. Whilst viewed favourably by young people, incentives did not necessarily translate into improvements in targeted behaviours. Conclusion: Evidence suggests that incentives schemes do not provide policy makers or practitioners with a simple route to improving young people’s health or other behaviours. However, there is evidence that incentives can be useful in encouraging positive health behaviour change where a simple or single action is required.

Broadening public participation in systematic reviews: a case example involving young people in two configurative reviews

Background Arguments supporting the involvement of users in research have even more weight when involving the public in systematic reviews of research. We aimed to explore the potential for public involvement in systematic reviews of observational and qualitative studies. Methods Two consultative workshops were carried out with a group of young people (YP) aged 12–17 years to examine two ongoing reviews about obesity: one about childrens views and one on the link between obesity and educational attainment. YP were invited to comment on the credibility of themes, to propose elements of interventions, to suggest links between educational attainment and obesity and to comment on their plausibility. Results Researchers had more confidence in review findings, after checking that themes identified as important by YP were emphasised appropriately. Researchers were able to use factors linking obesity and attainment identified as important by YP to identify limitations in the scope of extant research. Conclusion Consultative workshops helped researchers draw on the perspectives of YP when interpreting and reflecting upon two systematic reviews. Involving users in judging synthesis credibility and identifying concepts was easier than involving them in interpreting findings. Involvement activities for reviews should be designed with review stage, purpose and group in mind.

‘Clustering’ documents automatically to support scoping reviews of research: a case study

BACKGROUND Scoping reviews of research help determine the feasibility and the resource requirements of conducting a systematic review, and the potential to generate a description of the literature quickly is attractive. AIMS To test the utility and applicability of an automated clustering tool to describe and group research studies to improve the efficiency of scoping reviews. METHODS A retrospective study of two completed scoping reviews was conducted. This compared the groups and descriptive categories obtained by automatically clustering titles and abstracts with those that had originally been derived using traditional researcher-driven techniques. RESULTS The clustering tool rapidly categorised research into themes, which were useful in some instances, but not in others. This provided a dynamic means to view each dataset. Interpretation was challenging where there were potentially multiple meanings of terms. Where relevant clusters were unambiguous, there was a high precision of relevant studies, although recall varied widely. CONCLUSIONS Policy-relevant scoping reviews are often undertaken rapidly, and this could potentially be enhanced by automation depending on the nature of the dataset and information sought. However, it is not a replacement for researcher-developed classification. The possibilities of further applications and potential for use in other types of review are discussed.