Brian Williams

To develop a theory-informed behaviour change intervention to promote appropriate hospital antibiotic use, guided by the Medical Research Council’s complex interventions framework.A phased approach...

Objective To assess and clarify the relations between selective serotonin reuptake inhibitor (SSRI) dose efficacy, acceptability (early treatment discontinuation (dropouts)), and tolerability (reported adverse drug effects), and critically evaluate methods previously used to examine SSRI dose-response effects for the treatment of depression in adults. Design Systematic review of reviews and meta-narrative synthesis. Data sources Embase, Medline, PsycINFO, Scopus, and the Cochrane Collaboration library, from 1975 to December 2021. Reference lists of national depression treatment guidelines were systemically searched by hand. Eligibility criteria for selecting studies Reviews assessing SSRI monotherapy dose-response effects for the treatment of depression in adults (age ≥18 years) reporting efficacy, acceptability, or tolerability. Reviews meeting inclusion criteria had a high degree of heterogeneity, due to methodological diversity; therefore, a meta-narrative synthesis approach was applied. Standard daily doses were defined as 20 mg citalopram, fluoxetine, paroxetine; 50 mg sertraline; and 10 mg escitalopram. Risk of bias was assessed using the Risk of Bias in Systematic Reviews tool, in line with Cochrane recommendations. Results The search identified 9138 records; 387 full text reports were assessed for eligibility, 42 of which matched the inclusion criteria. The majority, 83% (n=35), of reviews included data for studies with a duration of ≤12 weeks (ie, the acute phase of depression treatment). Of 39 reviews assessing efficacy, the majority (n=26) indicated that individual SSRIs and SSRI class demonstrated flat dose-response effects; standard doses were optimal for efficacy. Acceptability or tolerability were assessed in 28 reviews. Higher than standard daily doses were associated with higher dropout rates and a greater incidence of adverse drug effects (eg, nausea, sexual dysfunction, fatigue, anxiety). Despite a range of methods being reported, there was an overall consensus regarding SSRI dose related efficacy, dropouts, and adverse drug effects. Conclusion Standard daily doses of SSRIs for the treatment of depression in adults provide a favourable balance between efficacy, acceptability, and tolerability. Patients are encouraged to talk to their prescriber or community pharmacist if they experience adverse effects or have any concerns about their drug treatments.

Background: Implementation depends on healthcare professionals being able to make sense of a new intervention in relation to their routine practice. Normalisation Process Theory refers to this as coherence work. However, specifying what it takes to achieve coherence is challenging because of variations in new interventions, routine practices and the relationship between them. Frameworks for intervention description may offer a way forward, as they provide broad descriptive categories for comparing complex interventions. To date such frameworks have not been informed by implementation theory, so do not account for the coherence work involved in holding aspects of routine practice constant while doing other aspects differently. Using speech and language therapy as an empirical exemplar, we explored therapists’ experiences of practice change and developed a framework to show how coherence of child speech interventions is achieved. Methods: We conducted a retrospective case-based qualitative study of how interventions for child speech problems had changed across three NHS speech and language therapy services and private practice in Scotland. A coherence framework was derived through interplay between empirical work with 42 therapists (using in-depth interviews, or self-organised pairs or small focus groups) and Normalisation Process Theory’s construct of coherence. Findings: Therapists reported a range of practice changes, which had demanded different types of coherence work. Non-traditional interventions had featured for many years in the profession’s research literature but not in clinical practice. Achieving coherence with these interventions was intellectually demanding because they challenged the traditional linguistic assumptions underpinning routine practice. Implementation was also logistically demanding, and therapists felt they had little agency to vary what was locally conventional for their service. In addition, achieving coherence took considerable relational work. Non-traditional interventions were often difficult to explain to children and parents, involved culturally uncomfortable repetitive drills and required therapists to do more tailoring of intervention for individual children. Conclusions: The intervention coherence framework has practical and theoretical applications. It is designed to help therapists, services and researchers anticipate and address barriers to achieving coherence when implementing non-routine interventions. It also represents a worked example of using theory to make intervention description both user-focused and implementation-friendly.

Socially disadvantaged men are at high risk of suffering from alcohol-related harm. Disadvantaged groups are less likely to engage with health promotion. There is a need for interventions that reach large numbers at low cost and which promote high levels of engagement with the behaviour change process. The aim of this study was to design a theoretically and empirically based text message intervention to reduce binge drinking by socially disadvantaged men. Following MRC guidance, the intervention was developed in four stages. Stage 1 developed a detailed behaviour change strategy based on existing literature and theory from several areas. These included the psychological theory that would underpin the intervention, alcohol brief interventions, text message interventions, effective behaviour change techniques, narratives in behaviour change interventions and communication theory. In addition, formative research was carried out. A logic model was developed to depict the pathways between intervention inputs, processes and outcomes for behaviour change. Stage 2 created a narrative which illustrated and modelled key steps in the strategy. Stage 3 rendered the intervention into a series of text messages and ensured that appropriate behavioural change techniques were incorporated. Stage 4 revised the messages to ensure comprehensive coverage of the behaviour change strategy and coherence of the narrative. It also piloted the intervention and made final revisions to it. The structured, systematic approach to design created a narrative intervention which had a strong theoretical and empirical basis. The use of a narrative helped make the intervention realistic and allowed key behaviour change techniques to be modelled by characters. The narrative was intended to promote engagement with the intervention. The intervention was rendered into a series of short text messages, and subsequent piloting showed they were acceptable in the target group. Delivery of an intervention by text message offers a low-cost, low-demand method that can reach large numbers of people. This approach provides a framework for the design of behaviour change interventions which could be used for interventions to tackle other health behaviours.

Background: Socially disadvantaged men are more likely to binge drink frequently and to experience high levels of alcohol-related harm.Objectives: To test the effectiveness and cost-effectiveness of a text message intervention in reducing the frequency of binge drinking among disadvantaged men.Study design: A four-centre, parallel-group, pragmatic, individually randomised controlled trial was conducted. Randomisation was carried out using a secure remote web-based system. It was stratified by participating centre and recruitment method and restricted using block sizes of randomly varying lengths.Setting: The study was conducted in the community. Members of the public helped to develop the study methods.Participants: Participants were men aged 25–44 years who had ≥ 2 episodes of binge drinking (> 8 units of alcohol in a single session) in the preceding 28 days. Men were recruited from areas of high deprivation.Interventions: An empirically and theoretically based text message intervention was delivered by 112 interactive text messages over a 12-week period. The control group received an attentional control comprising 89 text messages on general health.Primary outcome measure: The primary outcome measure was the proportion of men consuming > 8 units of alcohol on ≥ 3 occasions (in the previous 28 days) at 12 months post intervention.Results: The recruitment target of 798 was exceeded and 825 men were randomised. Retention was high and similar in the intervention (84.9%) and control (86.5%) groups. Most men in the intervention group engaged enthusiastically with the text messages: almost all (92%) replied to text messages and over two-thirds (67%) replied more than 10 times. The intervention was estimated to have had a modest, statistically non-significant effect on the primary outcome at the 12-month follow-up [odds ratio 0.79, 95% confidence interval (CI) 0.57 to 1.08]. This corresponds to a net reduction of 5.7% in regular binge drinking. Five secondary outcomes showed small non-significant and inconsistent effects on alcohol consumption, with one suggesting a positive effect and four suggesting an adverse effect. Both the short- and the long-term cost per quality-adjusted life-year (QALY) analysis suggested that the brief intervention was dominated by a ‘do-nothing’ option. The intervention’s impacts on patterns of alcohol consumption, QALYs and downstream costs were inconsistent and uncertain.Limitations: The study used an active control that, combined with the recruitment procedures and baseline assessments, could have biased the treatment effect towards the null. The measurement of alcohol consumption relied on self-reported drinking.Conclusions: The trial has demonstrated that it is possible to recruit and retain large numbers of socially disadvantaged men in a research study. The text messages delivered a complex theoretically and empirically based intervention that fostered enthusiastic engagement with the key components of the behaviour change sequence. The intervention produced a modest, statistically non-significant effect on the primary outcome, with wide CIs. Further research is needed to reduce uncertainty about the treatment effect. The methods developed for this study provide a platform for the design and testing of interventions to reduce inequalities in health.Future work: A future trial could reduce the uncertainty around the treatment effect of the intervention.Trial registration: Current Controlled Trials ISRCTN07695192.Funding: This study was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 6, No. 6. See NIHR Journals Library website for further information.

Purpose: To examine the feasibility of undertaking a pragmatic single-blind randomised controlled trial (RCT) of a visual arts participation programme to evaluate effects on survivor wellbeing within stroke rehabilitation. Methods: Stroke survivors receiving in-patient rehabilitation were randomised to receive eight art participation sessions (n = 41) or usual care (n = 40). Recruitment, retention, preference for art participation and change in selected outcomes were evaluated at end of intervention outcome assessment and three-month follow-up. Results: Of 315 potentially eligible participants 81 (29%) were recruited. 88% (n = 71) completed outcome and 77% (n = 62) follow-up assessments. Of eight intervention group non-completers, six had no preference for art participation. Outcome completion varied between 97% and 77%. Running groups was difficult because of randomisation timing. Effectiveness cannot be determined from this feasibility study but effects sizes suggested art participation may benefit emotional wellbeing, measured on the positive and negative affect schedule, and self-efficacy for Art (d = 0.24–0.42). Conclusions: Undertaking a RCT of art participation within stroke rehabilitation was feasible. Art participation may enhance self-efficacy and positively influence emotional wellbeing. These should be outcomes in a future definitive trial. A cluster RCT would ensure art groups could be reliably convened. Fewer measures, and better retention strategies are required.

The benefits of physical activity are well established, yet large numbers of people are not sufficiently active to gain health benefits. Certain population groups are less physically active than others, including older women from areas of high economic deprivation. The Well!Bingo project was established with the aim of engaging such women in the development of a health promotion intervention in a bingo club. This paper reports on the assessment of health status, physical activity and sedentary behaviour of women attending a bingo club in central Scotland, UK as part of the Well!Bingo project. Women attending the bingo club were invited to provide information on demographic characteristics, and self-reported physical activity and sedentary behaviour via a self-complete questionnaire as part of a cross-sectional study (n = 151). A sub-sample (n = 29) wore an accelerometer for an average of 5.7 ± 1.4 days. Differences between younger (under 60 years) and older adults (60 years and over) were assessed using a chi-square test for categorical data and the independent samples t-test was used to assess continuous data (p < 0.05). The mean age was 56.5 ± 17.7 years, with 57% living in areas of high deprivation (Scottish Index of Multiple Deprivation quintile one and two). Sixty-three percent of women (n = 87) reported they were meeting physical activity guidelines. However, objective accelerometer data showed that, on average, only 18.1 ± 17.3 min a day were spent in moderate to vigorous physical activity. Most accelerometer wear time was spent sedentary (9.6 ± 1.7 h). For both self-report and accelerometer data, older women were significantly less active and more sedentary than younger women. On average, older women spent 1.8 h more than younger women in sedentary activities per day, and took part in 21 min less moderate to vigorous physical activity (9.4 mins per day). The findings of this study suggest that bingo clubs are settings that attract women from areas of high deprivation and older women in bingo clubs in particular would benefit from interventions to target their physical activity and sedentary behaviour. Bingo clubs may therefore be potential intervention settings in which to influence these behaviours.