We assessed associations between intravaginal practices (IVPs) and the incidence of sexually transmitted infections (STIs) and bacterial vaginosis (BV) among women using the dapivirine vaginal ring (DVR) or placebo vaginal ring in southwestern Uganda.

This was a retrospective secondary analysis of data collected from women at risk of HIV infection recruited into the Ring Study. The latter evaluated the safety and efficacy of the DVR between 2013 and 2016. At baseline, a behavioural questionnaire was administered to obtain information on sexual activity and IVP (exposure) defined as; insertion inside the vagina of any items aimed at cleaning the vagina for any reason before, during or after sex other than practices to manage menses. Each participant self-inserted the DVR/placebo and replaced it every 4 weeks for 2 years. Outcomes were diagnosis of STIs, that is, Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas vaginalis (TV), HIV and BV. The incidence rate of STI/BV was estimated, overall, by IVP and trial arm in single-event-per-participant and multiple-event-per-participant analyses.

Of the 197 women enrolled, 66 (33.5%) were

IVP was not associated with risk of STIs/BV in the Ring Study.

NCT01539226.

Dementia is a complex medical condition that poses significant challenges to healthcare systems and support services. People living with dementia (PLWD) and their carers experience complex needs often exacerbated by social isolation and challenges in accessing support. Social prescribing (SP) seeks to enable PLWD and their carers to access community and voluntary sector resources to support them address such needs. Existing research, however, does not describe what SP interventions are currently in place in dementia care. Little is known about the needs these interventions are designed to address, the reasons that lead PLWD and their carers to participate in them, their effectiveness and the extent to which they could increase positive health outcomes if adopted and how.

A complex intervention systematic review of SP for PLWD and/or their carers will be conducted using an iterative logic model approach. Six electronic (MEDLINE, EMBASE, PsycINFO, CINAHL, Scopus and Cochrane/CENTRAL) and two grey literature databases (EThOS and CORE) were searched for publications between 1 January 2003 and June 2023, supplemented by handsearching of reference lists of included studies. Study selection, data extraction and risk of bias assessment, using Gough’s Weight of Evidence Framework, will be independently performed by two reviewers. A narrative approach will be employed to synthesise and report quantitative and qualitative data. Reporting will be informed by the Preferred Reporting Items for Systematic Review and Meta-Analysis Complex Interventions extension statement and checklist.

No ethical approval is required due to this systematic review operating only with secondary sources. Findings will be disseminated through peer-reviewed publications, conference presentations and meetings with key stakeholders including healthcare professionals, patient and carer groups, community organisations (eg, the Social Prescribing Network and the Evidence Collaborative at the National Academy for Social Prescribing), policymakers and funding bodies.

CRD42023428625.

Describe new opioid prescription claims, their clinical indications and annual trends among opioid naïve adults covered by the Quebec’s public drug insurance plan (QPDIP) for the fiscal years 2006/2007–2019/2020.

A retrospective observational study was conducted using data collected between 2006/2007 and 2019/2020 within the Quebec Integrated Chronic Disease Surveillance System, a linkage administrative data.

A cohort of opioid naïve adults and new opioid users was created for each study year (median number=2 263 380 and 168 183, respectively, over study period).

No.

A new opioid prescription was defined as the first opioid prescription claimed by an opioid naïve adult during a given fiscal year. The annual incidence proportion for each year was then calculated and standardised for age. A hierarchical algorithm was built to identify the most likely clinical indication for this prescription. Descriptive and trend analyses were performed.

There was a 1.7% decrease of age-standardised annual incidence proportion during the study period, from 7.5% in 2006/2007 to 5.8% in 2019/2020. The decrease was highest after 2016/2017, reaching 5.5% annual percentage change. Median daily dose and days’ supply decreased from 27 to 25 morphine milligram equivalent/day and from 5 to 4 days between 2006/2007 and 2019/2020, respectively. Between 2006/2007 and 2019/2020, these prescriptions’ most likely clinical indications increased for cancer pain from 34% to 48%, for surgical pain from 31% to 36% and for dental pain from 9% to 11%. Inversely, the musculoskeletal pain decreased from 13% to 2%. There was good consistency between the clinical indications identified by the algorithm and prescriber’s specialty or user’s characteristics.

New opioid prescription claims (incidence, dose and days’ supply) decreased slightly over the last 14 years among QPDIP enrollees, especially after 2016/2017. Non-surgical and non-cancer pain became less common as their clinical indication.

Non-communicable diseases cause 74% of global deaths, with cardiovascular diseases as the major contributor. Hypertension, a primary risk factor for cardiovascular disease, is highly prevalent in Africa. Diagnosis, treatment and control rates are notably limited in rural areas. This limitation results in increased risks of premature mortality and complications such as stroke due to socioeconomic, cultural and geographical challenges. Progress in African countries enhancing hypertension services through primary health care interventions exists. However, a comprehensive review of all primary health care interventions addressing undiagnosed and uncontrolled hypertension in rural African settings is lacking. This scoping review aims to categorise primary health care interventions targeting undiagnosed and uncontrolled hypertension in rural African adults. Intervention components will be mapped to the four stages outlined in the hypertension care cascade to develop a pilot intervention logic model for rural African adults with hypertension.

The scoping review protocol will adhere to the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Studies considered for inclusion will include any intervention delivered by any healthcare provider in a rural African primary care setting targeting any stage of hypertension care. Eight databases will be searched without date restrictions, supplemented by grey literature and reference list searches. A two-stage screening process (title/abstract and full text) will determine evidence source eligibility. All eligible sources of evidence will be extracted, charted and evaluated using the Template for Intervention Description and Replication checklist. A pilot logic model categorising and mapping interventions to the four stages of the hypertension care cascade will be visually presented and analysed using narrative synthesis.

No primary data will be collected; therefore, ethics approval is not required. Findings will be disseminated to local health authorities in Ghana and other African Regions and through national and international conferences and publications in peer-reviewed journals.

Social status, which encompasses various psychosocial dimensions, such as income, education and social relationships, can have a significant impact on physical and mental health outcomes. The study aims to explore the association among subjective social status, health and well-being among individuals aged 55 years and older in China and South Korea.

Sample population included individuals aged 55 years and older: China (n=1779) and South Korea (n=421).

Outcome measures included self-reported health status and well-being which were assessed by life satisfaction and general happiness.

The percentage of participants who reported a ‘very good’ health condition was higher in South Korea (14.5%) than in China (11.0%). The percentage of participants who reported feeling very satisfied (14.7%) with their life was lower in South Korea (11.8%). In China, 6.7% of the respondents reported their health as ‘very bad’ (rating 5), while in South Korea, this percentage was higher at 18.1%. Regression analysis revealed an inverse association among higher social status and poorer health, lower life satisfaction and lower happiness levels. For example, individuals who placed themselves in the highest social status category had 0.26 times lower odds (95% CI=0.13 to 0.55) of reporting poorer self-rated health status than those in the lowest category. Similarly, compared with individuals who place themselves in the lowest social status category, those who place themselves in the highest social status category have 0.03 times lower odds of reporting lower life satisfaction (95% CI=0.02 to 0.07).

Overall, the results highlight a significant association among social status, subjective health, life satisfaction and general happiness in both the countries. Health policymakers should identify effective strategies to promote healthy ageing and reduce disparities in health and well-being outcomes among older adults from different social backgrounds.

Up to 78% of patients who had a stroke develop post-stroke dysphagia (PSD), a significant consequence. Life-threatening aspiration pneumonia, starvation, and water and electrolyte abnormalities can result. Several meta-analyses have shown that repeated transcranial magnetic stimulation (rTMS) improves swallowing in patients who had a stroke; however, the optimum model is unknown. This study will be the first Bayesian network meta-analysis (NMA) to determine the best rTMS modalities for swallowing of patients who had a stroke.

PubMed, Web of Science, Embase, Google Scholar, Cochrane, the Chinese National Knowledge Infrastructure, the Chongqing VIP Database and WanFang Data will be searched from their creation to 2 September 2023. All randomised controlled trials associated with rTMS for PSD will be included. Only Chinese or English results will be studied. Two researchers will independently review the literature and extract data, then use the Cochrane Collaboration’s Risk of Bias 2.0 tool to assess the included studies’ methodological quality. The primary outcome is swallowing function improvement, whereas secondary outcomes include side effects (eg, paraesthesia, vertigo, seizures) and quality of life. A pairwise meta-analysis and NMA based on a Bayesian framework will be conducted using Stata and R statistical software. The Grading of Recommendations Assessment, Development, and Evaluation system will assess outcome indicator evidence quality.

As all data in this study will be taken from the literature, ethical approval is not needed. We will publish our work in peer-reviewed publications and present it at academic conferences.

CRD42023456386.

Audit and Feedback (A&F) is a widely used quality improvement (QI) intervention in healthcare. However, not all feedback is accepted by professionals. While claims-based feedback has been previously used for A&F interventions, its acceptance by medical specialists is largely unknown. This study examined medical specialists’ acceptance of claims-based A&F for QI.

Qualitative design, with focus group discussions. Transcripts were analysed using discourse analysis.

A total of five online focus group discussions were conducted between April 2021 and September 2022 with 21 medical specialists from varying specialties (urology; paediatric surgery; gynaecology; vascular surgery; orthopaedics and trauma surgery) working in academic or regional hospitals in the Netherlands.

Participants described mixed views on using claims-based A&F for QI. Arguments mentioned in favour were (1) A&F stimulates reflective learning and improvement and (2) claims-based A&F is more reliable than other A&F. Arguments in opposition were that (1) A&F is insufficient to create behavioural change; (2) A&F lacks clinically meaningful interpretation; (3) claims data are invalid for feedback on QI; (4) claims-based A&F is unreliable and (5) A&F may be misused by health insurers. Furthermore, participants described several conditions for the implementation of A&F which shape their acceptance.

Using claims-based A&F for QI is, for some clinical topics and under certain conditions, accepted by medical specialists. Acceptance of claims-based A&F can be shaped by how A&F is implemented into clinical practice. When designing A&F for QI, it should be considered whether claims data, as the most resource-efficient data source, can be used or whether it is necessary to collect more specific data.

To analyse monthly changes in public access defibrillation (PAD) incidence and outcomes of out-of-hospital cardiac arrest (OHCA) during the 2020–2021 COVID-19 pandemic compared with those during the 2016–2019 prepandemic period with consideration of pandemic-related movement restriction.

Retrospective cohort study.

An extended database was created by combining and reconciling the nationwide Utstein-style OHCA and the emergency medical service (EMS) transportation databases in Japan.

We analysed 226 182 EMS-witnessed, non-newborn and out-of-home OHCA cases in Japan.

The primary outcomes were the PAD incidence and neurologically favourable 1-month survival rate. The secondary outcomes were bystander cardiopulmonary resuscitation (CPR) provision and dispatcher-assisted CPR attempts.

The proportion of out-of-home OHCA cases slightly decreased during the pandemic (from 33.7% to 31.9%). Although the pandemic was associated with a decreased PAD incidence, 2-year trend analyses by an interaction test showed that the PAD incidence was lower during the first nationwide declaration of a state of emergency (p

Prolonged and repeated movement restrictions during the COVID-19 pandemic worsened the OHCA outcomes concurrently with disturbed BLS actions, including the reduced PAD incidence in out-of-home settings. Maintaining BLS training, re-arranging automated external defibrillator placement and establishing a local alert system for recruiting well-trained citizens to the scene are essential.

This modelling study aimed to estimate the burden for allergic diseases in children during a period of 30 years.

Population-based observational study.

The data on the incidence, mortality and disability-adjusted life years (DALYs) for childhood allergic diseases, such as atopic dermatitis (AD) and asthma, were retrieved from the Global Burden of Disease study 2019 online database. This data set spans various groups, including different regions, ages, genders and Socio-Demographic Indices (SDI), covering the period from 1990 to 2019.

In 2019, there were approximately 81 million children with asthma and 5.6 million children with AD worldwide. The global incidence of asthma in children was 20 million. Age-standardised incidence rates showed a decrease of 4.17% for asthma, from 1075.14 (95% uncertainty intervals (UI), 724.63 to 1504.93) per 100 000 population in 1990 to 1030.33 (95% UI, 683.66 to 1449.53) in 2019. Similarly, the rates for AD decreased by 5.46%, from 594.05 (95% UI, 547.98 to 642.88) per 100 000 population in 1990 to 561.61 (95% UI, 519.03 to 608.29) in 2019. The incidence of both asthma and AD was highest in children under 5 years of age, gradually decreasing with age. Interestingly, an increase in SDI was associated with a rise in the incidence of both conditions. However, the mortality rate and DALYs for asthma showed a contrasting trend.

Over the past three decades, there has been a worldwide increase in new asthma and AD cases, even though mortality rates have significantly declined. However, the prevalence of these allergic diseases among children varies considerably across regions, countries and age groups. This variation highlights the need for precise prevalence assessments. These assessments are vital in formulating effective strategies for prevention and treatment.

Inadequate counselling of pregnant women regarding pregnancy danger signs contributes to a delay in deciding to seek care, which causes up to 77% of all maternal deaths in developing countries. However, its spatial variation and region-specific predictors have not been studied in Ethiopia. Hence, the current study aimed to model its predictors using geographically weighted regression analysis.

The 2019 Ethiopian Mini Demographic and Health Survey data were used. A total weighted sample of 2922 women from 283 clusters was included in the final analysis. The analysis was performed using ArcGIS Pro, STATA V.14.2 and SaTScan V.10.1 software. The spatial variation of inadequate counselling was examined using hotspot analysis. Ordinary least squares regression was used to identify factors for geographical variations. Geographically weighted regression was used to explore the spatial heterogeneity of selected variables to predict inadequate counselling.

Significant hotspots of inadequate counselling regarding pregnancy danger signs were found in Gambella region, the border between Amhara and Afar regions, Somali region and parts of Oromia region. Antenatal care provided by health extension workers, late first antenatal care initiation and antenatal care follow-up at health centres were spatially varying predictors. The geographically weighted regression model explained about 66% of the variation in the model.

Inadequate counselling service regarding pregnancy danger signs in Ethiopia varies across regions and there exists within country inequality in the service provision and utilisation. Prioritisation and extra efforts should be made by concerned actors for those underprivileged areas and communities (as shown in the maps), and health extension workers, as they are found in the study.

Epilepsy is a common neurological disorder characterised by recurrent seizures. Almost half of patients who have an unprovoked first seizure (UFS) have additional seizures and develop epilepsy. No current predictive models exist to determine who has a higher risk of recurrence to guide treatment. Emerging evidence suggests alterations in cognition, mood and brain connectivity exist in the population with UFS. Baseline evaluations of these factors following a UFS will enable the development of the first multimodal biomarker-based predictive model of seizure recurrence in adults with UFS.

200 patients and 75 matched healthy controls (aged 18–65) from the Kingston and Halifax First Seizure Clinics will undergo neuropsychological assessments, structural and functional MRI, and electroencephalography. Seizure recurrence will be assessed prospectively. Regular follow-ups will occur at 3, 6, 9 and 12 months to monitor recurrence. Comparisons will be made between patients with UFS and healthy control groups, as well as between patients with and without seizure recurrence at follow-up. A multimodal machine-learning model will be trained to predict seizure recurrence at 12 months.

This study was approved by the Health Sciences and Affiliated Teaching Hospitals Research Ethics Board at Queen’s University (DMED-2681-22) and the Nova Scotia Research Ethics Board (1028519). It is supported by the Canadian Institutes of Health Research (PJT-183906). Findings will be presented at national and international conferences, published in peer-reviewed journals and presented to the public via patient support organisation newsletters and talks.

NCT05724719.

Between 2009/2010 and 2019/2020, England witnessed an increase in suspected head and neck cancer (sHNC) referrals from 140 to 404 patients per 100 000 population. 1 in 10 patients are not seen within the 2-week target, contributing to patient anxiety. We will develop a pathway for sHNC referrals, based on the Head and Neck Cancer Risk Calculator. The evolution of a patient-reported symptom-based risk stratification system to redesign the sHNC referral pathway (EVEREST-HN) Programme comprises six work packages (WPs). This protocol describes WP1 and WP2. WP1 will obtain an understanding of language to optimise the SYmptom iNput Clinical (SYNC) system patient-reported symptom questionnaire for sHNC referrals and outline requirements for the SYNC system. WP2 will codesign key elements of the SYNC system, including the SYNC Questionnaire, and accompanying behaviour change materials.

WP1 will be conducted at three acute National Health Service (NHS) trusts with variation in service delivery models and ensuring a broad mixture of social, economic and cultural backgrounds of participants. Up to 150 patients with sHNC (n=50 per site) and 15 clinicians (n=5 per site) will be recruited. WP1 will use qualitative methods including interviews, observation and recordings of consultations. Rapid qualitative analysis and inductive thematic analysis will be used to analyse the data. WP2 will recruit lay patient representatives to participate in online focus groups (n=8 per focus group), think-aloud technique and experience-based codesign and will be analysed using qualitative and quantitative approaches.

The committee for clinical research at The Royal Marsden, a research ethics committee and the Health Research Authority approved this protocol. All participants will give informed consent. Ethical issues of working with patients on an urgent cancer diagnostic pathway have been considered. Findings will be disseminated via journal publications, conference presentations and public engagement activities.

To analyse the differences between nurses with and without substance use disorders (SUDs) admitted to a specialised mental health programme.

Retrospective, observational study.

Specialised mental health treatment programme for nurses in Catalonia, Spain.

1091 nurses admitted to the programme from 2000 to 2021.

None.

Sociodemographic, occupational and clinical variables were analysed. Diagnoses followed Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision criteria.

Most nurses admitted to the programme were women (88%, n=960) and came voluntarily (92.1%, n=1005). The mean age at admission was 45 (SD=10.4) years. The most common diagnoses were adjustment disorders (36.6%, n=399), unipolar mood disorders (25.8%, n=282), anxiety disorders (16.4%, n=179) and SUDs (13.8%, n=151). Only 19.2% (n=209) of the sample were hospitalised during their first treatment episode. After multivariate analysis, suffering from a SUD was significantly associated with being a man (OR=4.12; 95% CI 2.49 to 6.82), coming after a directed referral (OR=4.55; 95% CI 2.5 to 7.69), being on sick leave at admission (OR=2.21; 95% CI 1.42 to 3.45) and needing hospitalisation at the beginning of their treatment (OR=12.5; 95% CI 8.3 to 20).

Nurses with SUDs have greater resistance to voluntarily asking for help from specialised mental health treatment programmes and have greater clinical severity compared with those without addictions. SUDs are also more frequent among men. More actions are needed to help prevent and promote earlier help-seeking behaviours among nurses with this type of mental disorder.

The CAPSTONE-1 trial demonstrated that adebrelimab-based immunotherapy yielded a favourable survival benefit compared with chemotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC). This study aims to evaluate the cost-effectiveness of this immunotherapy in the treatment of ES-SCLC from a healthcare system perspective in China.

The TreeAge Pro software was used to establish a three-state partitioned survival model. Survival data came from the CAPSTONE-1 trial (NCT03711305), and only direct medical costs were included. Utility values were obtained from the published literature. Sensitivity analysis was performed to explore the robustness of the model. The cost-effectiveness of immunotherapy was investigated through scenario and exploratory analyses in various settings.

Total costs, incremental costs, life years, quality-adjusted life-years (QALYs), incremental QALYs and incremental cost-effectiveness ratio (ICER).

The basic analysis revealed that the adebrelimab group achieved a total of 1.1 QALYs at a cost of US$65 385, while the placebo group attained 0.78 QALYs at a cost of US$12 741. ICER was US$163 893/QALY. Sensitivity analysis confirmed that the model was robust. Results from scenario and exploratory analyses indicated that the combination of adebrelimab and chemotherapy did not demonstrate cost-effectiveness in any scenario.

From the perspective of the Chinese healthcare system, adebrelimab in combination with chemotherapy for the treatment of ES-SCLC was not economical compared with chemotherapy.

Armed conflicts and intimate partner violence (IPV) impose a burden on individual and societal well-being. Given the history of armed conflict in Afghanistan and the high prevalence of IPV, this study aims to examine the influence of armed conflicts on IPV among Afghan women.

Multilevel logistic regression models were applied to the 2015 Afghanistan Demographic and Health Survey (N=10 414 women aged 15–49). Armed conflict severity was measured using the conflict index issued by the Office for the Coordination of Humanitarian Affairs, IPV was measured by three types of violence, including emotional, physical and sexual violence. All analyses were conducted by using STATA V.15.1.

Over 52% of women experienced at least one type of IPV, with 33.01%, 49.07%, and 8.99% experiencing emotional, physical, and sexual violence, respectively. The regression results show that armed conflicts were significantly and positively associated with the experience of all types of IPV. In addition, the association between armed conflicts and the experience of emotional IPV was positively moderated by women’s attitudes towards IPV.

Our findings suggest that women living in high-conflict regions were more prone to experience IPV, particularly women with positive attitudes towards IPV. Promoting progressive gender roles, women’s empowerment, awareness of IPV and inclusion of women in conflict resolution will help deal with the issue of IPV.

Cardiometabolic disease (CMD) is the leading cause of mortality in China. A healthy diet plays an essential role in the occurrence and development of CMD. Although the Chinese heart-healthy diet is the first diet with cardiovascular benefits, a healthy dietary pattern that fits Chinese food culture that can effectively reduce the risk of CMD has not been found.

The study is a single-centre, open-label, randomised controlled trial aimed at evaluating the effect of the Reducing Cardiometabolic Diseases Risk (RCMDR) dietary pattern in reducing the risk of CMDs in people with dyslipidaemia and providing a reference basis for constructing a dietary pattern suitable for the prevention of CMDs in the Chinese population. Participants are men and women aged 35–45 years with dyslipidaemia in Tianjin. The target sample size is 100. After the run-in period, the participants will be randomised to the RCMDR dietary pattern intervention group or the general health education control group with a 1:1 ratio. The intervention phases will last 12 weeks, with a dietary intervention of 5 working days per week for participants in the intervention group. The primary outcome variable is the cardiometabolic risk score. The secondary outcome variables are blood lipid, blood pressure, blood glucose, body composition indices, insulin resistance and 10-year risk of cardiovascular diseases.

The study complies with the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings and the Declaration of Helsinki. Signed informed consent will be obtained from all participants. The study has been approved by the Medical Ethics Committee of the Second Hospital of Tianjin Medical University (approval number: KY2023020). The results from the study will be disseminated through publications in a peer-reviewed journal.

Chinese Clinical Trial Registry (ChiCTR2300072472).

The high prevalence of cannabis use and the potential for negative effects indicate the need for effective prevention strategies and treatment of people who use cannabis. Studies show that harm reduction (HR) in cannabis use is effective in minimising the harmful consequences of the substance. However, health professionals often misunderstand it and resist its adoption due to various obstacles. To our knowledge, there has been no review of the scientific literature on the factors that facilitate or hinder practitioners’ adoption of HR in cannabis use. To fill this gap, we aim to identify, through a scoping review, facilitators and barriers to healthcare providers’ adoption of HR in cannabis use in Organisation for Economic Cooperation and Development (OECD) countries.

Our methodology will be guided by the six-step model initially proposed by Arksey and O’Malley (2005). The search strategy will be executed on different databases (Medline, PsycINFO, CINAHL, Web of Science, Embase, Sociological Abstracts, Érudit, BASE, Google Web and Google Scholar) and will cover articles published between 1990 and October 2022. Empirical studies published in French or English in an OECD country and identifying factors that facilitate or hinder healthcare providers’ adoption of HR in cannabis use, will be included. Reference lists of the selected articles as well as relevant systematic reviews will be scanned to identify any missed publications by the electronic searches.

Ethics approval is not required. The results will be disseminated through various activities (eg, publication in peer-reviewed journals, conferences, webinars and knowledge translation activities). The results will also allow us to conduct a future study aiming to develop and implement a knowledge translation process among healthcare practitioners working with youth in Quebec in order to enhance their adoption of HR in cannabis use.

Nationwide lifestyle intervention—specific health guidance (SHG) in Japan—employs counselling and education to change unhealthy behaviours that contribute to metabolic syndrome, especially obesity or abdominal obesity. We aimed to perform a model-based economic evaluation of SHG in a low participation rate setting.

A hypothetical population, comprised 50 000 Japanese aged 40 years who met the criteria of the SHG, used a microsimulation using the Markov model to evaluate SHG’s cost-effectiveness compared with non-SHG. This hypothetical population was simulated over a 35-year time horizon.

SHG is conducted annually by all Japanese insurers.

Model parameters, such as costs and health outcomes (including quality-adjusted life-years, QALYs), were based on existing literature. Incremental cost-effectiveness ratios were estimated from the healthcare payer’s perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted to evaluate the uncertainty around the model input parameters.

The simulation revealed that the total costs per person in the SHG group decreased by JPY53 014 (US$480) compared with that in the non-SHG group, and the QALYs increased by 0.044, wherein SHG was considered the dominant strategy despite the low participation rates. PSA indicated that the credibility intervals (2.5th–97.5th percentile) of the incremental costs and the incremental QALYs with the SHG group compared with the non-SHG group were –JPY687 376 to JPY85 197 (–US$6226 to US$772) and –0.009 to 0.350 QALYs, respectively. Each scenario analysis indicated that programmes for improving both blood pressure and blood glucose levels among other risk factors for metabolic syndrome are essential for improving cost-effectiveness.

This study suggests that even small effects of counselling and education on behavioural modification may lead to the prevention of acute life-threatening events and chronic diseases, in addition to the reduction of medication resulting from metabolic syndrome, which results in cost savings.

Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation.

The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022.

ISRCTN11499185.

An association between deep sedation and adverse short-term outcomes has been demonstrated although this evidence has been inconsistent. The A2B (alpha-2 agonists for sedation in critical care) sedation trial is designed to determine whether the alpha-2 agonists clonidine and dexmedetomidine, compared with usual care, are clinically and cost-effective. The A2B intervention is a complex intervention conducted in 39 intensive care units (ICUs) in the UK. Multicentre organisational factors, variable cultures, perceptions and practices and the involvement of multiple members of the healthcare team add to the complexity of the A2B trial. From our pretrial contextual exploration it was apparent that routine practices such as type and frequency of pain, agitation and delirium assessment, as well as the common sedative agents used, varied widely across the UK. Anticipated challenges in implementing A2B focused on the impact of usual practice, perceptions of risk, ICU culture, structure and the presence of equipoise. Given this complexity, a process evaluation has been embedded in the A2B trial to uncover factors that could impact successful delivery and explore their impact on intervention delivery and interpretation of outcomes.

This is a mixed-methods process evaluation guided by the A2B intervention logic model. It includes two phases of data collection conducted during and at the end of trial. Data will be collected using a combination of questionnaires, stakeholder interviews and routinely collected trial data. A framework approach will be used to analyse qualitative data with synthesis of data within and across the phases. The nature of the relationship between delivery of the A2B intervention and the trial primary and secondary outcomes will be explored.

All elements of the A2B trial, including the process evaluation, are approved by Scotland A Research Ethics Committee (Ref. 18/SS/0085). Dissemination will be via publications, presentations and media engagement.

NCT03653832.