Dietary weight-management for type 2 diabetes remissions in South Asians: the South Asian diabetes remission randomised trial for proof-of-concept and feasibility (STANDby).

Background: We aimed to assess whether a structured weight management programme incorporating a total diet replacement (TDR) (3-5 months ∼850 kcal/day formula diet) weight loss phase is acceptable to people of South Asian ethnicity and can achieve type 2 diabetes (T2D) remissions similarly to other populations. Methods: Adults of South Asian ethnicity, aged 18-65 years, with T2D for ≤4 years, and BMI 25-45 kg/m2 were recruited from primary care and social media, and randomised to commence TDR either immediately (iTDR), or delayed (dTDR) for 3-5 months as a usual care control arm during this period. Intervention effects were tested in randomised comparisons powered to detect significant weight loss, and in an expanded observational analysis to determine remission effect size, including both iTDR and dTDR groups. Acceptability in those recruited was explored by questionnaire and weight change. Trial registration: Current Controlled Trials, ISRCTN10720065. Date of Registration 27/09/2017. Findings: Twenty-five eligible individuals were recruited. Mean baseline (SD) age was 45.8 (11.1) years, weight 88.2 (13.7) kg, BMI 32.1 (3.8) kg/m2, HbA1c 60.4 (11.3) mmol/mol, liver fat by MRI 15.6 (9.4)%. In the RCT, mean(SD) weight change after TDR was -7.7 (7.2)% in the intervention group (n = 13), and -1.2 (1.4)% in the usual-care control group (n = 12) (p = 0.005), with T2D remission achieved by 5/13, compared to 0/12 respectively (p = 0.039). In the observational study, 23/25 started TDR and 19/23 participants completed the TDR phase. Median time spent in TDR was 105 days (IQR 77-134 days). T2D remission was achieved in 10/23 (43%), and weight changes were concordant with the RCT. Overall, 8/23 (35%) lost over 10% bodyweight. Absolute liver fat proportion near halved from 15.3% at the start of TDR to 8.6% (p < 0.001). Interpretation: In UK-based South Asians, TDR-led weight loss and T2D remission rates are comparable to those observed in white cohorts, and the intervention was acceptable in most of those recruited. There is potential to further improve outcomes, but one-third lost >10% body weight, and the mechanism underpinning T2D remission appears similar, driven by weight change with loss of excess ectopic body-fat. Funding: We gratefully acknowledge funding for the MRI scans from the, Miss MJM Smith Trust (registered charity: SC040586). No other external funds were provided for this trial. NS is supported by the British Heart Foundation Research Excellence Award (RE/18/6/34217).

The remote diet intervention to reduce Long COVID symptoms trial (ReDIRECT): protocol for a randomised controlled trial to determine the effectiveness and cost-effectiveness of a remotely delivered supported weight management programme for people with Long COVID and excess weight, with personalised improvement goals.

Objectves: The Remote Diet Intervention to Reduce Long COVID Symptoms Trial (ReDIRECT) evaluates whether the digitally delivered, evidence-based, cost-effective Counterweight-Plus weight management programme improves symptoms of Long COVID in people with overweight/obesity. Methods: Baseline randomised, non-blinded design with 240 participants allocated in a 1:1 ratio either to continue usual care or to add the remotely delivered Counterweight-Plus weight management programme, which includes a Counterweight dietitian supported delivery of 12 weeks total diet replacement, food reintroduction, and long-term weight loss maintenance. Randomisation is achieved by accessing a web-based randomisation system incorporated into the study web portal developed by a registered Clinical Trials Unit. We are using an innovative approach to outcome personalisation, with each participant selecting their most dominant Long COVID symptom as their primary outcome assessed at six months. Participants in the control arm enter the weight management programme after six months. We are recruiting participants from social media and existing networks (e.g., Long COVID Scotland groups), through newspaper advertisements and from primary care. Main inclusion criteria: people with Long COVID symptoms persisting > three months, aged 18 years or above, body mass index (BMI) above 27kg/m 2 (>25kg/m 2 for South Asians). The trial includes a process evaluation (involving qualitative interviews with participants and analysis of data on dose, fidelity and reach of the intervention) and economic evaluation (within-trial and long-term cost-utility analyses). Anticipated results: The recruitment for this study started in December 2021 and ended in July 2022. Project results are not yet available and will be shared via peer-reviewed publication once the six-months outcomes have been analysed. Trial registration: Current Controlled Trials ISRCTN12595520.

While most people infected with COVID-19 recover within a short amount of time, some people continue to have symptoms for 12 weeks or longer. This condition is known as Long COVID. Roughly two-thirds of people with Long COVID are overweight, a proportion similar to that found in the general population. Being overweight may worsen symptoms such as fatigue, breathlessness and pains. Weight management programmes in adults with overweight/obesity can reduce such symptoms, however we do not know how effective intentional weight loss is to reduce symptoms for people with Long COVID. The aim of this project is to test a well-established weight management programme, delivered and supported remotely, in people with Long COVID. The trial is conducted with 240 people with Long COVID, identified through their GP, patient groups, social media, or newspaper advertisements. A total of 120 individuals will receive the personalised, professionally supported weight management programme (treatment group), and 120 participants are allocated to usual care (control group). The one-year long weight management programme involves 12 weeks of total diet replacement (TDR) using soups and shakes, followed by food reintroduction and weight maintenance. Food based alternatives are available to those who are unable, or prefer not to, follow the TDR approach. The two groups will be compared for Long COVID symptoms, weight loss, quality of life and value for money after six months. After six months, the weight management programme will also be provided for the control group. Experiences while on the programme will be documented for 12 months for all participants. People with Long COVID have been involved extensively in developing this project. Their priorities are to reduce symptoms like fatigue, breathlessness and pain. They are keen to explore if effective weight management would help their symptoms and overall functioning, especially a programme that can be followed remotely from home. A group of patients and other stakeholders has been set up to provide advice throughout the project.

Patient-reported barriers to medication adherence in heart failure in Scotland.

OBJECTIVES: Medication adherence is the end result of a complex set of interwoven factors. Non-adherence with medication in heart failure patients is associated with excess mortality and morbidity. Studies describing interventions to improve adherence in heart failure are limited by a lack of robust methods and inconsistent outcomes. The aim of this evaluation was to explore the barriers to medication adherence in Scottish heart failure patients in order to inform the development of complex interventions. METHODS: Qualitative patient interviews. Participants were aged ≥18 years with current or previous signs or symptoms of clinical heart failure, reduced left ventricular ejection fraction ≤45% and confirmed adherence of <80% in tablet counts of heart failure therapy. Thematic analysis was employed. KEY FINDINGS: Eleven patients were recruited. The median age was 79 years old, and participants were typically from socially deprived communities. Participants were prescribed a mean 9.9 different medications per day. Seven distinct themes emerged around barriers to medication adherence: co-morbidity; treatment burden; health literacy; trust in NHS; socioeconomic factors; autonomy and health expectations. CONCLUSIONS: The factors affecting medication adherence in heart failure are multi-factorial and are unlikely to be improved by one single-faceted intervention. Future interventions need to treat patients holistically, build their trust as partners, simplify complex treatment regimens where possible and involve educational and social elements. The skill set and opportunities afforded to pharmacists may be well placed to deliver many of these aspects but this would need tested in the context of the development of complex interventions.

Multimorbidity, disadvantage, and patient engagement within a specialist homeless health service in the UK: an in-depth study of general practice data.

BACKGROUND: There is a paucity of current health data regarding users of a specialist homeless health service in the UK. AIM: To describe the health of users of a specialist homeless health service by assessing levels of multimorbidity, social exclusion - by measuring severe and multiple disadvantage (SMD) - and patient engagement with health care. DESIGN & SETTING: Analysis of patient-level data from computerised records of patients registered with a specialist homeless health service in Glasgow, Scotland. METHOD: Data for 133 patients were extracted using a data extraction form. Multimorbidity and SMD were described using categorisation adapted from previous literature in this field. Stepwise regression analysis was carried out to assess the relationship between domains of SMD experienced and the number of long-term conditions (LTCs) a patient had. RESULTS: The average age of patients in the cohort was 42.8 years, however levels of multimorbidity were comparable to those aged ≥85 years in the general population. The average number of LTCs was 2.8 per patient, with 60.9% of patients having both mental and physical comorbidity. SMD was categorised into three domains: homelessness; substance misuse; and previous imprisonment. More than 90.0% of patients experienced ≥2 domains of SMD, and SMD experiences were associated with multimorbidity: as domains of SMD experiences increased, so did the number of LTCs a patient was recorded as having. CONCLUSION: This cohort of patients has a complex burden of health and social care needs, which may act as barriers in the provision of effective health care.

The association of elevated trough serum vancomycin concentrations with obesity.

BACKGROUND: Obese patients display differences in vancomycin drug disposition, which may complicate attainment of appropriate serum vancomycin concentrations (SVCs). This study was conducted to determine if obesity leads to trough SVCs above the therapeutic range. METHODS: This retrospective cohort study sought to determine the rate and predictors of high (i.e. >20 mg/L) serum trough levels according to level of obesity. RESULTS: Increasing BMI predicted SVCs > 20 mg/L after controlling for dose, age, and serum creatinine. Obese patients had significantly higher mean trough SVCs compared to non-obese patients (16.5 mg/L vs 12.1 mg/L, p = 0.004) and a significantly higher proportion of obese patients had trough SVCs > 20 mg/L (18.9% vs 4.2%, p = 0.03). CONCLUSION: Increasing obesity predicted higher probabilities of SVCs > 20 mg/L. Development of alternative dosing and management strategies for vancomycin may be necessary to account for pharmacokinetic changes associated with obesity.

The Heart failure and Optimal Outcomes from Pharmacy Study (HOOPS): rationale, design, and baseline characteristics.

AIMS: The effect on mortality and morbidity of pharmacist-led intervention to optimize pharmacological therapy in patients with systolic heart failure (HF) has not been tested in a large-scale, long-term, clinical trial. METHODS: We describe the rationale and design of a UK, primary care-based, prospective cluster-randomized controlled trial of a pharmacist-led intervention in HF and report baseline characteristics of the patients randomized. Eighty-seven practices (1092 patients) were assigned to the intervention arm and 87 practices (1077 patients) to usual care. The average age of patients at baseline was 71 years, 70% were male, 86% were treated with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and 62% with a beta-blocker. Data for the primary outcome of death from any cause or hospitalization for HF will be available up to 31 December 2010, giving a mean follow-up of 5 years. More than 750 patients would have experienced the primary outcome during this period. The first secondary outcome is death from any cause or hospitalization for a cardiovascular reason. Deaths and hospitalizations are being identified using the Scottish National Health Service electronic patient record-linkage system (hence the delay between the end of follow-up and database lock). CONCLUSION: This trial is powered to provide a robust evaluation of the effect of pharmacist-led treatment optimization in patients with systolic HF in primary care.