Rumana Newlands

Intervention vignettes as a qualitative tool to refine complex intervention design

Background In trial design, decisions are made about which intervention components/processes to standardise and which remain flexible to maximise utility and/or effectiveness. The intervention-context-system fit for complex interventions impacts on trial recruitment, delivery and outcomes. Survey vignettes and discrete choice experiments are quantitative researcher led approaches which focus on a few measurable attributes. Our aim was to explore the utility of qualitative vignettes as a methodological tool allowing service users/providers to contribute to intervention design.

Quality improvement of community pharmacy services:a prioritisation exercise

Effective strategies are needed to translate knowledge (evidence) into practice to improve the quality of community pharmacy services. We report the first step of a novel knowledge translation process which involved the systematic identification and prioritisation of community pharmacy services in Scotland which were perceived to require improvement and/or guideline development.

Systematic Techniques to Enhance rEtention in Randomised controlled trials: the STEER study protocol

BackgroundNon-retention of participants seriously affects the credibility of clinical trial results and significantly reduces the potential of a trial to influence clinical practice. Non-retention can be defined as instances where participants leave the study prematurely. Examples include withdrawal of consent and loss to follow-up and thus outcome data cannot be obtained. The majority of existing interventions targeting retention fail to describe any theoretical basis for the observed improvement, or lack of improvement. Moreover, most of these interventions lack involvement of participants in their conception and/or design, raising questions about their relevance and acceptability. Many of the causes of non-retention involve people performing a behaviour (e.g. not returning a questionnaire). Behaviour change is difficult, and the importance of a strong theoretical basis for interventions that aim to change behaviour is increasingly recognised. This research aims to develop and pilot theoretically informed, participant-centred, evidence-based behaviour change interventions to improve retention in trials.MethodsThis research will generate data through semi-structured interviews on stakeholders’ perspectives of the reasons for trial non-retention. It will identify perceived barriers and enablers to trial retention using the Theoretical Domains Framework. The intervention development work will involve identification of behaviour change techniques, using recognised methodology, and co-production of retention interventions through discussion groups with end-users. An evaluation of intervention acceptability and feasibility will be conducted in focus groups. Finally, a ready-to-use evaluation framework to deploy in Studies Within A Trial as well as an explanatory retention framework will be developed for identifying and tackling modifiable issues to improve trial retention.DiscussionWe believe this to be one of the first studies to apply a theoretical lens to the development of interventions to improve trial retention that have been informed by, and are embedded within, participants’ experiential accounts. By developing and identifying priority interventions this study will support efforts to reduce research waste.

Interventions to promote weight loss in women treated for breast cancer: a systematic review

Introduction: It is generally accepted that weight loss has significant physiological benefits, such as reduced risk of diabetes, lowered blood pressure and blood lipid levels. However, few behavioural and dietary interventions have investigated psychological benefit as the primary outcome. Method: Systematic review methodology was adopted to evaluate the psychological outcomes of weight loss following participation in a behavioural and/or dietary weight loss intervention in overweight/obese populations. 35 studies were selected for inclusion and were reviewed. Results: Changes in self-esteem, depressive symptoms, body image and health related quality of life (HRQoL) were evaluated and discussed.The results demonstrated consistent improvements in psychological outcomes concurrent with and sometimes without weight loss. Improvements in body image and HRQoL (especially vitality) were closely related to changes in weight. Conclusion: Although the quality of the studies reviewed was generally acceptable, only 8 out of 35 studies included a suitable control/comparison group and the content, duration of intervention and measures used to assess psychological outcomes varied considerably. Further research is required to improve the quality of studies assessing the benefits of weight loss to fully elucidate the relationship between weight loss and psychological outcomes.Introduction: The role of the workplace as an opportunity for improving health has been highlighted in recent reports. The East Midlands Platform for Health and Wellbeing is a network of private, public and voluntary sector organisations working to improve health and reduce obesity. Member organisations commit to undertake actions to improve health and wellbeing of employees, individuals and/or communities. As part of Slimming World’s commitment, this pilot assessed the merits of providing weight management support via the workplace at two large regional employers. Methods: 278 British Gas and Nottingham University Hospitals NHS Trust employees were offered 12 weeks’ support at either a bespoke workplace group or established community-based Slimming World group. Weight change was recorded weekly. Dietary and physical activity behaviours, along with aspects of psychological health were assessed by questionnaire pre and post-programme. Results: 121 employees (meeting inclusion criteria) joined a workplace-based group and 114 a community-based group. Weight and attendance: Mean joining BMI was 32.4kg/m2. 138 (59%) participants completed the programme (attended within final 4 weeks).Behaviour changes: Participants who completed both questionnaires (n=87), reported positive changes in dietary and physical activity behaviours (all p<.001) (figure 1), and psychological health (mental wellbeing, self-worth and self-esteem, all p<0.05). There were no significant differences between worksite and community intervention groups for any outcomes. Conclusion: Providing weight management support via the workplace significantly reduced weight of participants (-3.9%). Completer analysis also revealed positive changes in healthy eating habits and activity levels, and also importantly psychological health, which may impact on working life. The Slimming World programme works effectively within both the work setting and via community-based provision when employees are recruited via the workplace.

Focus group discussions to inform the design of a weight loss programme suitable for overweight and obese women treated for breast cancer

Women who are overweight or obese at the time of breast cancer diagnosis and/or who gain weight after diagnosis are at higher risk for adverse clinical outcomes. Therefore, improving the quality of life and reducing the risk of recurrence for this population group has become very important. Only a few interventions have been conducted targeting weight loss for women already treated for breast cancer. The present study used qualitative research to inform the design of a weight loss intervention for women treated for breast cancer. As part of the development of the intervention, 15 women were recruited from a local female cancer support charity, who had previously undergone treatment for breast cancer. Three focus group discussions were held, led by a dietitian (JC) in a local cancer support centre. Topics addressed in the focus groups included post diagnosis weight issues, eating and exercise patterns, barriers to maintaining a healthy weight, and their past experience of and future preferences for a weight loss programme. All meetings were recorded and transcribed verbatim by a trained typist. The data was analysed using Framework analysis. The protocol was approved by the North of Scotland Research Ethics Committee. Analysis of the data revealed that majority of the women had put on weight during their treatment and/or post treatment. The most commonly reported causes for their weight gain were lifestyle changes, side-effects of treatments and the menopause, though some women thought it was difficult to isolate the cause of their weight gain. Although a number of women had tried different diets and joined various health clubs and slimming clubs, they discussed a number of barriers towards weight loss including lack of energy and selfesteem, lack of knowledge and self-motivation, lack of guidance from health professionals and disability due to arm, hip and muscle pain. But many would have liked to join a weight loss programme to improve their self-confidence. Their preference was for a programme delivered three to six months after completion of hospital treatment either in a group of women treated for breast cancer or one-to-one sessions followed by a small group. They would have liked this programme to be delivered in a non-clinical setting e.g. a cancer support centre or a community centre. Their preference was for gentle exercises such as slow dance with music, yoga, walking, swimming and also any healthy dietary advice which would stop the cancer recurring. The findings from these focus group discussions, along with results from a questionnaire survey in a larger more representative sample informed from these discussions, will aid in the design of a weight loss intervention suitable for women treated for breast cancer.

A survey to inform the design of a weight loss programme for overweight and obese women treated for breast cancer

Overweight or obesity is an established negative prognostic factor for a poorer outcome in patients treated for breast cancer. The average weight gains during treatment usually range from 2.5–6.2 kg. As part of a programme of work to design a weight loss intervention for women treated for breast cancer, a survey was conducted targeting this population of interest, to determine their attitudes, beliefs and future preferences for a programme for its successful design and implementation. The questionnaire was developed following on from focus group discussions and re-drafted following pre-testing with seven women using the ‘think-aloud’ technique. The survey was conducted (April–June 2011) with women attending follow-up appointments in the outpatient breast clinic at the Aberdeen Royal Infirmary (ARI). An invitation letter was posted out two weeks prior to their clinic appointments, along with a consent form and a study information sheet. The women were then approached in the clinic by the researchers who discussed the study, measured height and weight and gave out the questionnaire with a stamped addressed envelope for return. A reminder was sent to all non-responders after 2 weeks. A subsample of the women who returned the questionnaires were also interviewed (telephone or face-to-face) to explore their views in further depth. The interview sample was selected depending on their responses to the questionnaire and their socio-demographic characteristics to provide a broad range of views and sample size was determined by reaching saturation in the responses. The survey achieved a good response rate (128/138, 93%). Most of the respondents were either overweight (n = 50, 38.8%) or obese (n = 34, 26.4%). The majority (n = 110, 85%) had never received any information from any health professionals on ‘how to maintain a healthy weight’ since diagnosis but they would have liked to receive it (n = 58, 45%) either straight away (48%) or within 3 months (26%) of their initial treatment (surgery, chemotherapy and radiotherapy). The preference for receiving any information varied by BMI category (69% obese vs 47% overweight, p = 0.006). Those who wanted information would have preferred to receive it in a hospital setting (41%), at a cancer support centre (38%) or GP surgery (38%) either one-to-one (63.8%) and/or in a group setting (48.3%). Among women who would have liked to do more physical activity (n = 52, 40.3%) following their initial treatment, 48% would have preferred to do this in a group of other women with breast cancer, 42% in a group of any women and 58% preferred on their own. Moreover, 50% and 37% would have liked to attend a group session once a week or twice a week respectively. The most popular physical activities were walking (85%), swimming (39%), yoga (37%) and pilates (37%). The interview data revealed a preference for a supervised weight loss programme (incorporating both diet and physical activities) for at least three months in a group setting, preferably delivered by a dietitian, with different learning and interactive sessions, and some encouragement and guidance for physical activity specific to their needs. There were mixed feelings about being regularly weighed and whether this should be done in the group or in private. Some women would have liked to involve their partners in the programme. These findings will be used in the design of a weight loss programme suitable for women treated for breast cancer.