Submitted in partial fulfilment of the requirements for the degree of Master of Public Health, in the field of Social and Behaviour Change Communications, in the University of the Witwatersrand, Johannesburg, 2012 / The Good Participatory Practice Guidelines recommend that research results are made available to a broad range of stakeholders, including policy makers and trial participants, yet there is little guidance on how this may be achieved. The Microbicides Development Programme (MDP301 trial) was a large scale clinical trial that took place at thirteen clinics in South Africa, Tanzania, Uganda and Zambia between 2004 and 2009. The results of this trial were released in late 2009 and a comprehensive, multi-method results dissemination plan was implemented to communicate the research findings to policy makers, key stakeholders, research staff, Community Advisory Boards and trial participants between December 2009 and November 2010. This study was a retrospective analysis which included a process evaluation (and costing) of the implementation of the results dissemination plan for the MDP301 trial and an analysis of how the incorporation of telephonic unblinding potentially benefited the research community.

Symptoms in patients receiving dialysis are common and associated with impaired quality of life. Symptoms are a top research priority because effective therapies are lacking and even with appropriate diagnosis and treatment, residual symptoms often persist. Clinical trials in the setting of kidney disease are challenging to conduct and as a result, nephrology lags behind other specialties regarding the degree to which clinical trials inform the care of patients with kidney disease, including those receiving dialysis. The studies in this thesis inform the design of randomized controlled trials with regards to run-in periods and the treatment of symptoms in patients with kidney disease. Chapter 2 describes a meta-epidemiologic study of the frequency, setting and purposes of run-in periods in parallel randomized controlled trials of self-administered medications for chronic diseases in adults. Chapter 3 is a study within a trial of an international randomized controlled trial that compares spironolactone to placebo for the prevention of cardiovascular morbidity and mortality in dialysis. It compares the ability of a 3-week study visit in addition to a 7-week study visit during an active-run-in period to identify and exclude participants with non-adherence. Chapter 4 is a protocol for a randomized placebo controlled crossover trial of low fixed dose pharmacologic therapy for restless legs syndrome in hemodialysis that includes a placebo run-in period for adherence and tolerability. Chapter 5 is a survey of Canadian nephrologists regarding the use of cannabinoids for symptom management in patients with kidney disease and support for their use in clinical trials. / Thesis / Doctor of Philosophy (PhD)

Students commonly engage in problem behaviors, yet teachers report handling difficult behavior as their biggest challenge. Some research over the last few decades has used functional analyses (FAs) to determine the function of student’s problem behavior and then developed functional-based interventions based on the FA findings. Despite the success of the studies, research has indicated traditional FA methodologies are not always feasible for teachers and/or schools. Therefore, a need still exists to develop better and more efficient ways to train teachers how to conduct FAs in the classroom. Thus, the purpose of the current study was to evaluate the effectiveness of using virtual video models to train future teachers how to conduct trial based functional analyses (TBFAs). Additionally, the current study sought to assess if the participants could generalize their skills learned virtually to an in person setting. Three future teachers enrolled in education courses at a southeastern university participated in the study and watched video models of each of the TBFA conditions (attention, demand, tangible, and ignore). After watching the videos, participants were then asked to conduct each trial virtually, and then complete each trial the following day in person. A multiple baseline design across participants was used, and results indicated the videos were effective at teaching the participants to conduct a TBFA. Specifically, all three future teachers successfully conducted every trial of a TBFA with high procedural integrity virtually. The virtual training then generalized well into an in person setting, with only one participant needing additional feedback. Additionally, results indicate the virtual intervention was socially valid for all participants. Limitations and directions for future research are also discussed.

The United States has established breastfeeding as an important health indicator within the Healthy People agenda. Healthy People target goals for breastfeeding initiation, duration, and exclusivity remain unmet. The US Surgeon General's Office reports that lack of knowledge and widespread misinformation about breastfeeding are barriers to meeting Healthy People goals. Breastfeeding mothers are vulnerable to messages that cast doubt on their ability to breastfeed. Very little research has examined specific approaches to help people resist negative messages about health beliefs and behaviors. The objective of this quasi-experimental study was to test an intervention designed to help mothers defend their breastfeeding decisions and resist influences that attempted to persuade them to give formula to their babies. Women attending prenatal breastfeeding classes were recruited and assigned to comparison and intervention groups. The intervention was a board game based on McGuire's inoculation theory of resistance to influence. Controlling for intention to breastfed, intervention and comparison groups were examined for differences in maternal self-efficacy to resist persuasion to give formula and breastfeeding rates for initiation, duration, and exclusivity. Data analyses consisted of analysis of covariance and logistic regression. There was no significant difference between comparison and intervention groups, both groups had high self-efficacy to resist giving formula to their babies; nor were there significant differences regarding breastfeeding initiation, duration and exclusivity. The lack of significant differences may have been influenced by ceiling effects in all of the breastfeeding variables, possibly due to the high socioeconomic level of the sample. The intervention may have worked better in women who were more prone to dissuasive influence, such as those with lower education.

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No / We co-designed and piloted ‘Festival in a Box’, an outreach programme to enable socially isolated people with dementia to engage with and enjoy cultural activities in their homes. It comprised 3–4 weekly home visits, each led by a professional artist to create art works using materials brought in ‘the box’. Activities included music, poetry, pottery, crafts and photography. We qualitatively interviewed 13 participants (6 people with dementia, 4 artists, 3 befrienders). Six participants with dementia completed, enjoyed and engaged with the planned visits. Main themes were: engagement, reflection on value of previous cultural activities, precariousness and isolation in current neighbourhood and the importance of a voice and being heard. Befrienders reported their preconceptions of what participants could do were challenged. Artists reported shifts in their preconceptions about dementia and the influence of the project on their professional practice. We propose that the ‘Festival in a Box’ pilot study suggests a means through which community arts festivals could work with socially isolated people with dementia to contribute to the creation of ‘Dementia Friendly Communities’. A larger-scale pilot study is now needed to develop this hypothesis.

Yes / Objectives To test whether an occupation based lifestyle intervention can sustain and improve the mental wellbeing of adults aged 65 years or over compared to usual care, using an individually randomised controlled trial. Participants 288 independently living adults aged 65 years or over, with normal cognition were recruited from two UK sites between December 2011 and November 2015. Interventions Lifestyle Matters is a NICE recommended multi-component preventive intervention designed to improve the mental wellbeing of community living older people at risk of decline. It involves weekly group sessions over four months and one to one sessions. Main outcome measures The primary outcome was mental wellbeing at 6 months (mental health dimension of the SF-36).Secondary outcomes included physical health dimensions of the SF-36, extent of depression (PHQ-9), quality of life (EQ-5D) and loneliness(de Jong Gierveld Loneliness Scale),assessed at 6 and 24 months. Results Data on 262 (intervention =136; usual care =126) participants were analysed using intention to treat analysis. Mean SF-36 mental health scores at six months differed by 2·3 points (95 CI -1·3 to 5·9; P=0·209) after adjustments. Conclusions Analysis shows little evidence of clinical or cost effectiveness in the recruited population with analysis of the primary outcome revealing that the study participants were mentally well at baseline. The results pose questions regarding how preventive interventions to promote wellbeing in older adults can be effectively targeted in the absence of proactive mechanisms to identify those who at risk of decline. / Primary Care Research Network (PCRN) funding was accessed to support recruitment activity in GP surgeries in Sheffield and NISCHR provided support in North Wales.

Yes / This article recounts our experience of eliciting, cataloguing and prioritizing conjectured Context-Mechanism-Outcome configurations at the outset of a realist evaluation, to provide new insight into how Context-Mechanism-Outcome configurations can be generated and theorized. Our construction of Context-Mechanism-Outcome configurations centred on how, why and in what circumstances teamwork was impacted by robotic surgery, rather than how and why this technology improved surgical outcomes as intended. We found that, as well as offering resources, robotic surgery took away resources from the theatre team, by physically reconfiguring the operating theatre and redistributing the surgical task load, essentially changing the context in which teamwork was performed. We constructed Context-Mechanism-Outcome configurations that explain how teamwork mechanisms were both constrained by the contextual changes, and triggered in the new context through the use of informal strategies. We conclude by reflecting on our application of realist evaluation to understand the potential impacts of robotic surgery on teamwork.