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Aims: Alcohol Minimum Unit Pricing (MUP) was introduced in Scotland in May 2018. Existing evidence suggests MUP can reduce drinking in the general population, but there is little evidence regarding its impact on vulnerable groups. This qualitative study aimed to capture the experiences of MUP among homeless drinkers, street drinkers, and the support services that work with them.

BackgroundGrowing evidence suggests that experiences in the early years play a major role in children’s development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives for the very early years (THRIVE) aims to evaluate two antenatal group interventions, Enhanced Triple P for Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy. As both interventions aim to improve maternal mental health and parenting skills, we hypothesise that in the longer term, participation may lead to an improvement in children’s life trajectories.MethodsTHRIVE is a three-arm, longitudinal, randomised controlled trial aiming to recruit 500 pregnant women with additional health or social care needs. Participants will be referred by health and social care professionals, predominately midwives. Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual. Groups will commence when participants are between 20 and 34 weeks pregnant.DiscussionThe population we aim to recruit are traditionally referred to as “hard to reach”, therefore we will monitor referrals received from maternity and social care pathways and will be open to innovation to boost referral rates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for group participation and retention. We anticipate the results of the trial will help inform policy and practice in supporting women with additional health and social care needs during antenatal and early postnatal periods. This is currently a high priority for the Scottish and UK Governments.Trial registrationInternational Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568. Registered on 28 February 2014 (registered retrospectively (by 3 months)).

Background: Growing evidence suggests that experiences in the early years play a major role in children's development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives for the very early years (THRIVE) aims to evaluate two antenatal group interventions, Enhanced Triple P for Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy. As both interventions aim to improve maternal mental health and parenting skills, we hypothesise that in the longer term, participation may lead to an improvement in children's life trajectories. Methods: THRIVE is a three-arm, longitudinal, randomised controlled trial aiming to recruit 500 pregnant women with additional health or social care needs. Participants will be referred by health and social care professionals, predominately midwives. Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual. Groups will commence when participants are between 20 and 34 weeks pregnant. Discussion: The population we aim to recruit are traditionally referred to as "hard to reach", therefore we will monitor referrals received from maternity and social care pathways and will be open to innovation to boost referral rates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for group participation and retention. We anticipate the results of the trial will help inform policy and practice in supporting women with additional health and social care needs during antenatal and early postnatal periods. This is currently a high priority for the Scottish and UK Governments. Trial registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568. Registered on 28 February 2014 (registered retrospectively (by 3 months)).

Background:\ud THRIVE is a three-arm randomised controlled trial (RCT) that aims to evaluate whether antenatal and early postnatal interventions, Enhanced Triple B for Baby (ETPB) plus care as usual (CAU) or Mellow Bumps (MB) plus CAU (versus CAU alone), can: 1) improve the mental health and well-being of pregnant women with complex health and social care needs; 2) improve mother-infant bonding and interaction; 3) reduce child maltreatment; and 4) improve child language acquisition. This paper focuses on THRIVE’s realist process evaluation, which is carefully monitoring what is happening in the RCT.\ud \ud Methods:\ud Realistic evaluation provides the theoretical rationale for the process evaluation. We question: 1) how faithfully are MB and ETPB implemented? 2) What are the mechanisms by which they work, if they do, and who do they work for and how? 3) What contextual factors are necessary for the programmes to function, or might prevent them functioning?\ud \ud The mixed-methods design includes quantitative measures, which are pre- and post-training/intervention questionnaires for facilitators and mothers-to-be, and post-session evaluation forms. Qualitative data collection methods include participant observation of facilitator training and the delivery of a series of antenatal sessions in selected intervention groups (n = 3 for ETPB and n = 3 for MB), semi-structured interviews with facilitators, pregnant women, partners, and referring facilitators, and telephone interviews examining the content of the postnatal components of ETPB and MB.\ud \ud Discussion:\ud The findings of this process evaluation will help researchers and decision makers interpret the outcomes of THRIVE. It will provide a greater understanding of: how the interventions work (if they do); the extent and quality of their implementation; contextual factors facilitating and constraining intervention functioning; variations in response within and between subgroups of vulnerable parents; and benefits or unintended consequences of either intervention. Few studies to date have published detailed research protocols illustrating how realist process evaluation is designed and conducted as an integral part of a randomised controlled trial.

Background: Multimorbidity is common in deprived communities and reduces quality of life quality. Our aim was to evaluate a whole system primary care-based complex intervention to improve quality of life in multimorbid patients living in areas of very high deprivation.Methods: Phase 2 exploratory cluster randomised controlled trial with 8 general practices in Glasgow in very deprived areas involving multimorbid patients aged 30-65 years. The intervention comprised structured longer consultations, relationship continuity, practitioner support, and self-management support. Control practices continued treatment as usual. Primary outcomes were quality of life (EQ-5D-5L utility scores) and wellbeing (W-BQ12; 3 domains). Cost-effectiveness from a health service perspective, engagement and retention were assessed. Recruitment and baseline measurements occurred prior to randomisation. Blinding post-randomisation was not possible; outcome measurement and analysis were masked. Analyses were by intention to treat.Results: Of 76 eligible practices contacted, 12 accepted, and 8 were selected, randomised and participated for the duration of the trial. Of 225 eligible patients, 152 (68%) participated and 67/76 (88%) in each arm completed 12-month assessment. Two patients died in the control group. CARE Plus significantly improved one domain of well-being (negative wellbeing); effect size 0·33 (95% CI 0·11 to 0·55) at 12 months (p=0·0036). Positive wellbeing, energy, and general wellbeing (the combined score of the three components) were not significantly influenced by the intervention at 12 months. EQ-5D-5L area under the curve (AUC) over the 12 months was higher in the CARE Plus group (p=0.002). The incremental cost in the CARE Plus group was £929 (95% CIs: £86, £1788) per participant with a gain in quality adjusted life years of 0·076 (95% CI: 0·028, 0·124) over the 12 months of the trial, resulting in a cost-effectiveness ratio of £12,224 per QALY gained. Modelling suggested that cost-effectiveness would continue.Conclusions: It is feasible to conduct a high quality cluster RCT of a complex intervention with multimorbid patients in primary care in areas of very high deprivation. Enhancing primary care through a whole-system approach may be a cost-effective way to protect quality of life multimorbid patients in deprived areas.Trial Registration: Trial registration: ISRCTN 34092919, assigned 14/1/2013.

METHODS\ud We used a phase 2 exploratory cluster randomised controlled trial with eight general practices in Glasgow in very deprived areas that involved multimorbid patients aged 30–65 years. The intervention comprised structured longer consultations, relationship continuity, practitioner support, and self-management support. Control practices continued treatment as usual. Primary outcomes were quality of life (EQ-5D-5L utility scores) and well-being (W-BQ12; 3 domains). Cost-effectiveness from a health service perspective, engagement, and retention were assessed. Recruitment and baseline measurements occurred prior to randomisation. Blinding post-randomisation was not possible but outcome measurement and analysis were masked. Analyses were by intention to treat.\ud \ud RESULTS\ud Of 76 eligible practices contacted, 12 accepted, and eight were selected, randomised and participated for the duration of the trial. Of 225 eligible patients, 152 (68 %) participated and 67/76 (88 %) in each arm completed the 12-month assessment. Two patients died in the control group. CARE Plus significantly improved one domain of well-being (negative well-being), with an effect size of 0.33 (95 % confidence interval [CI] 0.11–0.55) at 12 months (p = 0.0036). Positive well-being, energy, and general well-being (the combined score of the three components) were not significantly influenced by the intervention at 12 months. EQ-5D-5L area under the curve over the 12 months was higher in the CARE Plus group (p = 0.002). The incremental cost in the CARE Plus group was £929 (95 % CI: £86–£1788) per participant with a gain in quality-adjusted life years of 0.076 (95 % CI: 0.028–0.124) over the 12 months of the trial, resulting in a cost-effectiveness ratio of £12,224 per quality-adjusted life year gained. Modelling suggested that cost-effectiveness would continue.\ud \ud CONCLUSIONS\ud It is feasible to conduct a high-quality cluster randomised control trial of a complex intervention with multimorbid patients in primary care in areas of very high deprivation. Enhancing primary care through a whole-system approach may be a cost-effective way to protect quality of life for multimorbid patients in deprived areas.

Background:Multimorbidity is common in patients living in areas of high socioeconomic deprivation and is associated with poor quality of life, but the reasons behind this are not clear. Exploring the ‘everyday life work’ of patients may reveal important barriers to self-management and wellbeing.Objective:To investigate the relationship between the management of multimorbidity and ‘everyday life work’ in patients living in areas of high socioeconomic deprivation in Scotland, as part of a programme of work on multimorbidity and deprivation.Design:Qualitative study: individual semi-structured interviews of 14 patients (8 women and 6 men) living in deprived areas with multimorbidity, exploring how they manage. Analysis was continuous and iterative. We report the findings in relation to everyday life work.Results:The in-depth analysis revealed four key themes: (i) the symbolic significance of everyday life work to evidence the work of being ‘normal’; (ii) the usefulness of everyday life work in managing symptoms; (iii) the impact that mental health problems had on everyday life work; and (iv) issues around accepting help for everyday life tasks. Overall, most struggled with the amount of work required to establish a sense of normalcy in their everyday lives, especially in those with mental–physical multimorbidity.Conclusions:Everyday life work is an important component of self-management in patients with multimorbidity in deprived areas, and is commonly impaired, especially in those with mental health problems. Interventions to improve self-management support for patients living with multimorbidity may benefit from an understanding of the role of everyday life work.&nbsp