Suzanne Audrey

Process evaluation of complex interventions: Medical Research Council guidance

Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies

An informal school-based peer-led intervention for smoking prevention in adolescence (ASSIST): a cluster randomised trial

Summary Background Schools in many countries undertake programmes for smoking prevention, but systematic reviews have shown mixed evidence of their effectiveness. Most peer-led approaches have been classroom-based, and rigorous assessments are scarce. We assessed the effectiveness of a peer-led intervention that aimed to prevent smoking uptake in secondary schools. Methods We undertook a cluster randomised controlled trial of 10 730 students aged 12–13 years in 59 schools in England and Wales. 29 schools (5372 students) were randomly assigned by stratified block randomisation to the control group to continue their usual smoking education and 30 (5358 students) to the intervention group. The intervention (ASSIST [A Stop Smoking In Schools Trial] programme) consisted of training influential students to act as peer supporters during informal interactions outside the classroom to encourage their peers not to smoke. Follow-up was immediately after the intervention and at 1 and 2 years. Primary outcomes were smoking in the past week in both the school year group and in a group at high risk of regular smoking uptake, which was identified at baseline as occasional, experimental, or ex-smokers. Analysis was by intention to treat. This study is registered, number ISRCTN55572965. Findings The odds ratio of being a smoker in intervention compared with control schools was 0·75 (95% CI 0·55–1·01) immediately after the intervention (n=9349 students), 0·77 (0·59–0·99) at 1-year follow-up (n=9147), and 0·85 (0·72–1·01) at 2-year follow-up (n=8756). The corresponding odds ratios for the high-risk group were 0·79 (0·55–1·13 [n=3561]), 0·75 (0·56–0·99 [n=3483]), and 0·85 (0·70–1·02 [n=3294]), respectively. In a three-tier multilevel model with data from all three follow-ups, the odds of being a smoker in intervention compared with control schools was 0·78 (0·64–0·96). Interpretation The results suggest that, if implemented on a population basis, the ASSIST intervention could lead to a reduction in adolescent smoking prevalence of public-health importance. Funding MRC (UK).

Process evaluation in complex public health intervention studies: the need for guidance

Public health interventions aim to improve the health of populations or at-risk subgroups. Problems targeted by such interventions, such as diet and smoking, involve complex multifactorial aetiology. Interventions will often aim to address more than one cause simultaneously, targeting factors at multiple levels (eg, individual, interpersonal, organisational), and comprising several components which interact to affect more than one outcome.1 They will often be delivered in systems which respond in unpredictable ways to the new intervention.2 Recognition is growing that evaluations need to understand this complexity if they are to inform future intervention development, or efforts to apply the same intervention in another setting or population.1 Achieving this will require evaluators to move beyond a ‘does it work?’ focus, towards combining outcomes and process evaluation. There is no such thing as a typical process evaluation, with the term applied to studies which range from a few simple quantitative items on satisfaction, to complex mixed-method studies exploring issues such as the process of implementation, or contextual influences on implementation and outcomes. As recognised within MRC guidance for evaluating complex interventions, process evaluation may be used to ‘assess fidelity and quality of implementation , clarify causal mechanisms and identify contextual factors associated with variation in outcomes’.1 This paper briefly discusses each of these core aims for process evaluation, before describing current Medical Research Council (MRC) Population Health Sciences Research Network (PHSRN) funded work to develop guidance for process evaluations of complex public health interventions. ### Intervention implementation An important role for process evaluations is to examine the quantity and quality of what was actually implemented in practice, and why. This may inform implementation of similar interventions elsewhere, and facilitate interpretation of intervention outcomes. While notions of standardisation are central to implementation assessment, the nature of …

What oncologists tell patients about survival benefits of palliative chemotherapy and implications for informed consent: qualitative study

Objective To examine how much oncologists tell patients about the survival benefit of palliative chemotherapy during consultations at which decisions about treatment are made. Design Qualitative study in which consultations were observed and digitally recorded. Setting Teaching hospital and district general hospital in south west England. Participants 37 patients with advanced non-small cell lung cancer (n=12), pancreatic cancer (n=13), and colorectal cancer (n=12); and nine oncologists, including four consultants and five registrars. Main outcome measures All recordings were transcribed completely, anonymised, and electronically coded with ATLAS.ti. Constant comparison was used to identify themes and patterns. The framework method of data management, in which data were charted, was used to aid transparency of interpretation. Results During the consultations, information given to patients about survival benefit included numerical data (“about four weeks”), an idea of timescales (“a few months extra”), vague references (“buy you some time”), or no mention at all. In most consultations (26/37) discussion of survival benefit was vague or non-existent. Conclusions Most patients were not given clear information about the survival gain of palliative chemotherapy. To aid decision making and informed consent, we recommend that oncologists sensitively describe the benefits and limitations of this treatment, including survival gain.

Inequalities in the uptake of Human Papillomavirus Vaccination: a systematic review and meta-analysis

Background The human papillomavirus (HPV) vaccine offers an opportunity to reduce health inequalities associated with cervical cancer provided the vaccine is delivered equitably at population level. Method We reviewed evidence of inequalities in HPV vaccine uptake in young women after undertaking a comprehensive search of databases from inception to March 2012. Studies that compared HPV vaccination initiation and/or completion by at least one ethnicity or socioeconomic-related variable in adolescent young women were included. There were no language restrictions. Data were extracted by two reviewers and pooled in a meta-analysis using a random-effects model; sub-analyses and meta-regression were undertaken to investigate sources of heterogeneity. Results In all, 29 publications related to 27 studies were included in the review. Black young women were less likely to initiate HPV vaccination compared with White young women (combined OR: 0.89, 95% CI: 0.82–0.97). In the USA, young women without healthcare insurance were less likely to initiate (combined OR: 0.56, 95% CI: 0.40–0.78). There was no strong evidence that lower family income (combined OR: 1.16, 95% CI: 1.00–1.34) or lower parental education (combined OR 1.06, 95% CI: 0.92–1.22) influenced HPV vaccination initiation. Conclusions We found strong evidence for differences in HPV vaccination initiation by ethnicity and healthcare coverage, but did not find a strong association with parental education or family income variables. The majority of studies originated from the USA. Population-based studies reporting both initiation and completion of the HPV vaccination programme are required to establish patterns of uptake in different healthcare contexts.

Barriers and facilitators to HPV vaccination of young women in high-income countries: a qualitative systematic review and evidence synthesis

BackgroundVaccination against Human Papillomavirus (HPV) is recommended for adolescent young women prior to sexual debut to reduce cervical cancer related mortality and morbidity. Understanding factors affecting decision-making of HPV vaccination of young women is important so that effective interventions can be developed which address barriers to uptake in population groups less likely to receive the HPV vaccine.MethodsWe undertook a qualitative systematic review and evidence synthesis to examine decision-making relating to the HPV vaccination of young women in high-income countries. A comprehensive search of databases from inception to March 2012 was undertaken to identify eligible studies reporting the perspectives of key stakeholders including policy makers, professionals involved in programme, parents, and young women. Factors affecting uptake of the vaccine were examined at different levels of the socio-ecological model (policy, community, organisational, interpersonal and intrapersonal).ResultsForty-one studies were included. Whether young women receive the HPV vaccine is strongly governed by the decisions of policy makers, healthcare professionals, and parents. These decisions are shaped by: financial considerations; social norms and values relating to sexual activity, and; trust in vaccination programmes and healthcare providers. Financial constraints may be overcome through universal healthcare systems offering the HPV vaccine free at the point of delivery. In the healthcare setting, judgements by healthcare professionals about whether to recommend the vaccine may restrict a young woman’s access to the vaccine irrespective of her own beliefs and preferences. Parents may decide not to allow their daughters to be vaccinated, based on cultural or religious perceptions about sexual activity.ConclusionsBarriers to the uptake of the HPV vaccine have implications for young women’s future sexual, physical and reproductive health. Interventions to address barriers to uptake of the vaccine should target appropriate, and multiple, levels of the socio-ecological model. Issues of trust require clear, accessible, and sometimes culturally appropriate, information about the HPV vaccination programme. Although young women are central to the HPV vaccination programme, their views are underrepresented in the qualitative literature. Future research should consider young women’s perceptions of, and involvement in, consent and decision-making.

Examining inequalities in the uptake of the school-based HPV vaccination programme in England: a retrospective cohort study

BACKGROUND Although uptake of Human Papillomavirus (HPV) vaccine is high in the United Kingdom, it is unknown whether the programme has been delivered equitably by ethnicity or deprivation. This study aimed to investigate factors associated with HPV vaccine initiation and completion within the routine HPV vaccination programme in the South West of England. METHODS Data were retrieved for young women eligible for routine vaccination from 2008/09 to 2010/11 from three Primary Care Trusts (PCTs)/local authorities. Multivariable logistic regression models were developed to examine factors associated with uptake of HPV vaccination. RESULTS Of 14 282 eligible young women, 12 658 (88.6%) initiated, of whom 11 725 (92.6%) completed the course. Initiation varied by programme year (86.5-89.6%) and PCTs/local authorities (84.8-91.6%). There was strong evidence for an overall difference of initiation by ethnicity (P < 0.001), but not deprivation quintile (P = 0.48). Young women educated in non-mainstream educational settings were less likely to initiate and, if initiated, less likely to complete (both P < 0.001). CONCLUSIONS HPV vaccination uptake did not vary markedly by social deprivation. However, associations with ethnicity and substantially lower uptake in non-mainstream educational settings were observed. Research to identify reasons for low vaccine uptake in these population groups is required.

Reducing Smoking in Adolescents: Cost-Effectiveness Results From the Cluster Randomized ASSIST (A Stop Smoking In Schools Trial)

Introduction: School-based smoking prevention programmes can be effective, but evidence on cost-effectiveness is lacking. We conducted a cost-effectiveness analysis of a school-based “peer-led” intervention. Methods: We evaluated the ASSIST (A Stop Smoking In Schools Trial) programme in a cluster randomized controlled trial. The ASSIST programme trained students to act as peer supporters during informal interactions to encourage their peers not to smoke. Fifty-nine secondary schools in England and Wales were randomized to receive the ASSIST programme or usual smoking education. Ten thousand seven hundred and thirty students aged 12–13 years attended participating schools. Previous work has demonstrated that the ASSIST programme achieved a 2.1% (95% CI = 0%–4.2%) reduction in smoking prevalence. We evaluated the public sector cost, prevalence of weekly smoking, and cost per additional student not smoking at 24 months. Results: The ASSIST programme cost of £32 (95% CI = £29.70–£33.80) per student. The incremental cost per student not smoking at 2 years was £1,500 (95% CI = £669–£9,947). Students in intervention schools were less likely to believe that they would be a smoker at age 16 years (odds ratio [OR] = 0.80; 95% CI = 0.66–0.96). Conclusions: A peer-led intervention reduced smoking among adolescents at a modest cost. The intervention is cost-effective under realistic assumptions regarding the extent to which reductions in adolescent smoking lead to lower smoking prevalence and/or earlier smoking cessation in adulthood. The annual cost of extending the intervention to Year 8 students in all U.K. schools would be in the region of £38 million and could result in 20,400 fewer adolescent smokers.

Process evaluation of health promotion interventions

This article uses two extended illustrations of current process evaluations to address areas of difficulty in health promotion design. There are no clear solutions to methodological problems that are rooted in competition between paradigms. Further,any design adopted must adapt to constraints of resources and time. Nevertheless, a multi-method approach can provide a pragmatic and realistic way forward, with the precise mix of methods selected being adapted to the particular requirements and constraints of the intervention project being evaluated.

High fidelity? How should we consider variations in the delivery of school-based health promotion interventions?

Objective The complexity and scale of health promotion interventions present challenges for the standardization of delivery. Furthermore, health promotion practice favours adapting interventions according to perceived client need. This paper examines the fidelity of intervention delivery within A Stop Smoking in Schools Trial (ASSIST), identifying if and why variations occurred, the consequences of these variations for the integrity of the intervention, and the broader implications for the delivery of evidence-based health promotion in schools. Design The ASSIST intervention involved influential Year 8 students being trained to encourage their peers, through informal conversations, to be smoke-free. Its effectiveness was evaluated by a pragmatic randomized controlled trial with an integral process evaluation to examine the context, implementation and receipt of the intervention. Setting Thirty secondary schools in South Wales and the west of England. Method A variety of methods, including interviews, questionnaires and observation, were used to obtain data from key participants. Qualitative data were analysed using the constant comparative method. Results Whilst overall fidelity was high, some variations were observed. Despite this variation, the intervention was largely delivered successfully and appropriately across a range of schools. Lessons learned from ASSIST enabled us to develop a model to categorize variations in intervention delivery. Conclusion The model developed can inform the design of health promotion interventions and identify the level of fidelity which should be expected outside of a trial. We believe that this model can contribute to good practice in the implementation of evidence-based health promotion in schools.