Tannaze Tinati

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

Vitamin D supplementation in pregnancy: a systematic review.

BACKGROUND It is unclear whether or not the current evidence base allows definite conclusions to be made regarding the optimal maternal circulating concentration of 25-hydroxyvitamin D [25(OH)D] during pregnancy, and how this might best be achieved. OBJECTIVES To answer the following questions: (1) What are the clinical criteria for vitamin D deficiency in pregnant women? (2) What adverse maternal and neonatal health outcomes are associated with low maternal circulating 25(OH)D? (3) Does maternal supplementation with vitamin D in pregnancy lead to an improvement in these outcomes (including assessment of compliance and effectiveness)? (4) What is the optimal type (D2 or D3), dose, regimen and route for vitamin D supplementation in pregnancy? (5) Is supplementation with vitamin D in pregnancy likely to be cost-effective? METHODS We performed a systematic review and where possible combined study results using meta-analysis to estimate the combined effect size. Major electronic databases [including Database of Abstracts of Reviews of Effects (DARE), Centre for Reviews and Dissemination (CRD), Cochrane Database of Systematic Reviews (CDSR) and the Health Technology Assessment (HTA) database] were searched from inception up to June 2012 covering both published and grey literature. Bibliographies of selected papers were hand-searched for additional references. Relevant authors were contacted for any unpublished findings and additional data if necessary. Abstracts were reviewed by two reviewers. INCLUSION AND EXCLUSION CRITERIA SUBJECTS pregnant women or pregnant women and their offspring. EXPOSURE either assessment of vitamin D status [dietary intake, sunlight exposure, circulating 25(OH)D concentration] or supplementation of participants with vitamin D or food containing vitamin D (e.g. oily fish). OUTCOMES offspring - birthweight, birth length, head circumference, bone mass, anthropometry and body composition, risk of asthma and atopy, small for gestational dates, preterm birth, type 1 diabetes mellitus, low birthweight, serum calcium concentration, blood pressure and rickets; mother - pre-eclampsia, gestational diabetes mellitus, risk of caesarean section and bacterial vaginosis. RESULTS Seventy-six studies were included. There was considerable heterogeneity between the studies and for most outcomes there was conflicting evidence. The evidence base was insufficient to reliably answer question 1 in relation to biochemical or disease outcomes. For questions 2 and 3, modest positive relationships were identified between maternal 25(OH)D and (1) offspring birthweight in meta-analysis of three observational studies using log-transformed 25(OH)D concentrations after adjustment for potential confounding factors [pooled regression coefficient 5.63 g/10% change maternal 25(OH)D, 95% confidence interval (CI) 1.11 to 10.16 g], but not in those four studies using natural units, or across intervention studies; (2) offspring cord blood or postnatal calcium concentrations in a meta-analysis of six intervention studies (all found to be at high risk of bias; mean difference 0.05 mmol/l, 95% CI 0.02 to 0.05 mmol/l); and (3) offspring bone mass in observational studies judged to be of good quality, but which did not permit meta-analysis. The evidence base was insufficient to reliably answer questions 4 and 5. LIMITATIONS Study methodology varied widely in terms of study design, population used, vitamin D status assessment, exposure measured and outcome definition. CONCLUSIONS The evidence base is currently insufficient to support definite clinical recommendations regarding vitamin D supplementation in pregnancy. Although there is modest evidence to support a relationship between maternal 25(OH)D status and offspring birthweight, bone mass and serum calcium concentrations, these findings were limited by their observational nature (birthweight, bone mass) or risk of bias and low quality (calcium concentrations). High-quality randomised trials are now required. STUDY REGISTRATION This study is registered as PROSPERO CRD42011001426. FUNDING The National Institute for Health Research Health Technology Assessment programme.

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 …

Closing the loop overnight at home setting: psychosocial impact for adolescents with type 1 diabetes and their parents

Objective To explore the experiences of adolescents with type 1 diabetes mellitus (T1DM) and their parents taking part in an overnight closed loop study at home, using qualitative and quantitative research methods. Research design and methods Adolescents aged 12–18 years on insulin pump therapy were recruited to a pilot closed loop study in the home setting. Following training on the use of a study insulin pump and continuous glucose monitoring (CGM), participants were randomized to receive either real-time CGM combined with overnight closed loop or real-time CGM alone followed by the alternative treatment for an additional 21 days with a 2–3-week washout period in between study arms. Semistructured interviews were performed to explore participants’ perceptions of the impact of the closed loop technology. At study entry and again at the end of each 21-day crossover arm of the trial, participants completed the Diabetes Technology Questionnaire (DTQ) and Hypoglycemia Fear Survey (HFS; also completed by parents). Results 15 adolescents and 13 parents were interviewed. Key positive themes included reassurance/peace of mind, confidence, ‘time off’ from diabetes demands, safety, and improved diabetes control. Key negative themes included difficulties with calibration, alarms, and size of the devices. DTQ results reflected these findings. HFS scores were mixed. Conclusions Closed loop insulin delivery represents cutting-edge technology in the treatment of T1DM. Results indicate that the psychological and physical benefits of the closed loop system outweighed the practical challenges reported. Further research from longitudinal studies is required to determine the long-term psychosocial benefit of the closed loop technology.

'Making every contact count': Evaluation of the impact of an intervention to train health and social care practitioners in skills to support health behaviour change.

A total of 148 health and social care practitioners were trained in skills to support behaviour change: creating opportunities to discuss health behaviours, using open discovery questions, listening, reflecting and goal-setting. At three time points post-training, use of the skills was evaluated and compared with use of skills by untrained practitioners. Trained practitioners demonstrated significantly greater use of these client-centred skills to support behaviour change compared to their untrained peers up to 1 year post-training. Because it uses existing services to deliver support for behaviour change, this training intervention has the potential to improve public health at relatively low cost.

The effect of a behaviour change intervention on the diets and physical activity levels of women attending Sure Start Children's Centres: results from a complex public health intervention.

Objectives The UK governments response to the obesity epidemic calls for action in communities to improve peoples health behaviour. This study evaluated the effects of a community intervention on dietary quality and levels of physical activity of women from disadvantaged backgrounds. Design Non-randomised controlled evaluation of a complex public health intervention. Participants 527 women attending Sure Start Childrens Centres (SSCC) in Southampton (intervention) and 495 women attending SSCCs in Gosport and Havant (control). Intervention Training SSCC staff in behaviour change skills that would empower women to change their health behaviours. Outcomes Main outcomes dietary quality and physical activity. Intermediate outcomes self-efficacy and sense of control. Results 1-year post-training, intervention staff used skills to support behaviour change significantly more than control staff. There were statistically significant reductions of 0.1 SD in the dietary quality of all women between baseline and follow-up and reductions in self-efficacy and sense of control. The decline in self-efficacy and control was significantly smaller in women in the intervention group than in women in the control group (adjusted differences in self-efficacy and control, respectively, 0.26 (95% CI 0.001 to 0.50) and 0.35 (0.05 to 0.65)). A lower decline in control was associated with higher levels of exposure in women in the intervention group. There was a statistically significant improvement in physical activity in the intervention group, with 22.9% of women reporting the highest level of physical activity compared with 12.4% at baseline, and a smaller improvement in the control group. The difference in change in physical activity level between the groups was not statistically significant (adjusted difference 1.02 (0.74 to 1.41)). Conclusions While the intervention did not improve womens diets and physical activity levels, it had a protective effect on intermediate factors—control and self-efficacy—suggesting that a more prolonged exposure to the intervention might improve health behaviour. Further evaluation in a more controlled setting is justified.

Low levels of food involvement and negative affect reduce the quality of diet in women of lower educational attainment

BACKGROUND Women of lower educational attainment tend to have poorer quality diets and lower food involvement (an indicator of the priority given to food) than women of higher educational attainment. The present study reports a study of the role of food involvement in the relationship between educational attainment and quality of diet in young women. METHODS The first phase uses six focus group discussions (n = 28) to explore the function of food involvement in shaping the food choices of women of lower and higher educational attainment with young children. The second phase is a survey that examines the relationship between educational attainment and quality of diet in women, and explores the role of mediating factors identified by the focus group discussions. RESULTS The focus groups suggested that lower food involvement in women of lower educational attainment might be associated with negative affect (i.e. an observable expression of negative emotion), and that this might mean that they did not place a high priority on eating a good quality diet. In support of this hypothesis, the survey of 1010 UK women found that 14% of the effect of educational attainment on food involvement was mediated through the womans affect (P ≤ 0.001), and that 9% of the effect of educational attainment on quality of diet was mediated through food involvement (P ≤ 0.001). CONCLUSIONS Women who leave school with fewer qualifications may have poorer quality diets than women with more qualifications because they tend to have a lower level of food involvement, partly attributed to a more negative affect. Interventions to improve womens mood may benefit their quality of diet.

Variety and quality of healthy foods differ according to neighbourhood deprivation

This study addresses a gap in the food environment literature by investigating spatial differences in the inter relationship of price, variety and quality of food in southern England. We conducted a survey of all grocery stores (n=195) in the city of Southampton, UK, and ranked neighbourhoods according to national quintiles of deprivation. We found no difference in availability or cheapest price across neighbourhoods. However, the poorest neighbourhoods had less variety of healthy products and poorer quality fruit and vegetables than more affluent neighbourhoods. Dietary inequalities may be exacerbated by differences in the variety and quality of healthy foods sold locally; these factors may influence whether or not consumers purchase healthy foods.

A mixed-methods investigation to explore how women living in disadvantaged areas might be supported to improve their diets

Mixed-methods explored the potential for using Sure Start Children’s Centres (SSCCs) to deliver an intervention to improve the diets of disadvantaged women and their children. In an ‘expert’ discussion, SSCC staff described gaining women’s trust, meeting needs and bringing about change as key to engaging women successfully. Structured observations in SSCCs showed they host activities in an environment conducive to building relationships and meeting women’s needs. However, staff often missed opportunities to support women to make dietary changes. These data suggest that an intervention to help staff make the most of these opportunities would have the best chance of success.

Measuring young women’s self-efficacy for healthy eating: initial development and validation of a new questionnaire

Healthy eating in women of childbearing age is critical to the health of future generations. Interventions that increase women’s dietary self-efficacy may be particularly effective at improving healthy eating. However, no validated tool exists to measure self-efficacy for healthy eating in this specific population. We therefore designed a new questionnaire (the 8-Item Self-Efficacy for Healthy Diet Scale) using a think-aloud study and expert panel consultation. We then pilot-tested the 8-Item Self-Efficacy for Healthy Diet Scale in an interviewer-administered survey of 94 women recruited primarily from community settings. The 8-Item Self-Efficacy for Healthy Diet Scale is an 8-item measure of self-efficacy for healthy eating with promising psychometric properties including internal consistency, convergent, criterion and divergent validity.