The vast majority of the 300 000 pregnancy-related deaths every year occur in South Asia and sub-Saharan Africa. Increased access to quality antepartum and intrapartum care can reduce pregnancy-related morbidity and mortality worldwide. We used a population-based cross-sectional cohort design to: (1) examine the sociodemographic risk factors and structural barriers associated with pregnancy care-seeking and institutional delivery, and (2) investigate the influence of residential distance to the nearest primary health facility in a rural population in Mali.

A baseline household survey of Malian women aged 15–49 years was conducted between December 2016 and January 2017, and those who delivereda baby in the 5 years preceding the survey were included. This study leverages the baseline survey data from a cluster-randomised controlled trial to conduct a secondary analysis. The outcomes were percentage of women who received any antenatal care (ANC) and institutional delivery; total number of ANC visits; four or more ANC visits; first ANC visit in the first trimester.

Of the 8575 women in the study, two-thirds received any ANC in their last pregnancy, one in 10 had four or more ANC visits and among those that received any ANC, about one-quarter received it in the first trimester. For every kilometre increase in distance to the nearest facility, the likelihood of the outcomes reduced by 5 percentage points (0.95; 95% CI 0.91 to 0.98) for any ANC; 4 percentage points (0.96; 95% CI 0.94 to 0.98) for an additional ANC visit; 10 percentage points (0.90; 95% CI 0.86 to 0.95) for four or more ANC visits; 6 percentage points (0.94; 95% CI 0.94 to 0.98) for first ANC in the first trimester. In addition, there was a 35 percentage points (0.65; 95% CI 0.56 to 0.76) decrease in likelihood of institutional delivery if the residence was within 6.5 km to the nearest facility, beyond which there was no association with the place of delivery. We also found evidence of increase in likelihood of receiving any ANC care and its intensity increased with having some education or owning a business.

The findings suggest that education, occupation and distance are important determinants of pregnancy and delivery care in a rural Malian context.

NCT02694055.

Little study has reported the association of maternal weight gain in early pregnancy with fetal congenital heart disease (CHD). We aimed to explore the potential relationship based on a China birth cohort while adjusting by multiple factors.

Cohort study.

China birth cohort study conducted from 2017 to 2021.

The study finally included 114 672 singleton pregnancies in the 6–14 weeks of gestation, without missing data or outliers, loss to follow-up or abnormal conditions other than CHD. The proportion of CHD was 0.65% (749 cases).

Association between maternal pre-pregnancy weight gain and CHD in the offspring were analysed by multivariate logistic regression, with the unadjusted, minimally adjusted and maximally adjusted methods, respectively.

The first-trimester weight gain showed similar discrimination of fetal CHD to that period of maternal body mass index (BMI) change (DeLong tests: p=0.091). Compared with weight gain in the lowest quartile (the weight gain less than 0.0 kg), the highest quartile (over 2.0 kg) was associated with a higher risk of fetal CHD in unadjusted (OR 1.36, 95% CI: 1.08 to 1.72), minimally adjusted (adjusted OR (aOR) 1.29, 95% CI: 1.02 to 1.62) and maximally adjusted (aOR 1.29, 95% CI: 1.02 to 1.63) models. The association remains robust in pregnant women with morning sickness, normal pre-pregnancy BMI, moderate physical activity, college/university level, natural conception or with folic acid (FA) and/or multivitamin supplementation.

Although the association of maternal pre-pregnancy weight gain on fetal CHD is weak, the excessive weight gain may be a potential predictor of CHD in the offspring, especially in those with morning sickness and other conditions that are routine in the cohort, such as normal pre-pregnancy BMI, moderate physical activity, college/university level, natural conception or with FA and/or multivitamin supplementation.

Non-adherence to antihypertensive medication significantly contributes to inadequate blood pressure control. Regarding non-pharmacological interventions to improve medication adherence, the question remains of which interventions yield the highest efficacy.

Understanding the complementary perspectives of patients and healthcare professionals can be valuable for designing strategies to enhance medication adherence. Few studies explored the perspectives of patients and healthcare professionals regarding medication adherence. None of them focused specifically on adherence to pharmacological therapy for hypertension in Portugal.

Considering the high prevalence of non-adherence and its location-specific aspects, the priority should be identifying its barriers and developing tactics to address them.

This study aims to gather the perspectives of patients with hypertension and healthcare professionals such as family doctors, nurses and community pharmacists from Portugal, regarding the most effective strategies to enhance antihypertensive medication adherence and to understand the factors contributing to non-adherence.

We will conduct qualitative research through synchronous online focus groups of 6–10 participants. Some groups will involve patients with hypertension, while others will include family doctors, nurses and community pharmacists. The number of focus groups will depend on the achievement of theoretical saturation. A purposive sample will be used. Healthcare participants will be recruited via email, while patients will be recruited through their family doctors.

The moderator will maintain neutrality while ensuring interactive contributions from every participant. Participants will be encouraged to express their opinions on the meeting summary. Meetings will be recorded and transcribed.

Two researchers will perform content analyses using MAXQDA V.12 through comparative analyses and subsequent consensus. A third researcher will review the analyses. The results will be presented narratively.

The Ethics Committee of the University of Coimbra has approved this study with the number: CE-026/2021. The results will be disseminated via peer-reviewed publications and national and international conferences.

Government guidance to manage COVID-19 was challenged by low levels of health and digital literacy and lack of information in different languages. ‘Covid Confidence’ sessions (CC-sessions) were evaluated to assess their effectiveness in counteracting misinformation and provide an alternative source of information about the pandemic.

We worked with community anchor organisations to co-ordinate online CC-sessions serving three economically deprived, ethnically mixed, neighbourhoods. We conducted a qualitative, participatory process evaluation, in tandem with the CC-sessions to explore whether a popular opinion leader/local champion model of health promotion could mobilise pandemic responses. Group discussions were supplemented by final interviews to assess changes in community capacity to mobilise.

Sheffield, England, September 2020 to November 2021.

Community leaders, workers and volunteers representing a variety of local organisations resulted in 314 attendances at CC-sessions. A group of local health experts helped organisations make sense of government information.

CC-sessions fostered cross-organisational relationships, which enabled rapid community responses. Community champions successfully adapted information to different groups. Listening, identifying individual concerns and providing practical support enabled people to make informed decisions on managing exposure and getting vaccinated. Some people were unable to comply with self-isolation due to overcrowded housing and the need to work. Communities drew on existing resources and networks.

CC-sessions promoted stronger links between community organisations which reduced mistrust of government information. In future, government efforts to manage pandemics should partner with communities to codesign and implement prevention and control measures.

The elimination of mother-to-child transmission (MTCT) of syphilis has been set as a public health priority. However, an instrument to predict the MTCT of syphilis is not available. We aimed to develop and validate an intuitive nomogram to predict the individualised risk of MTCT in pregnant women with syphilis in China.

Retrospective cohort study.

Data was acquired from the National Information System of Prevention of MTCT of Syphilis in Guangdong province between 2011 and 2020.

A total of 13 860 pregnant women with syphilis and their infants were included and randomised 7:3 into the derivation cohort (n=9702) and validation cohort (n=4158).

Congenital syphilis.

Among 13 860 pregnant women with syphilis and their infants included, 1370 infants were diagnosed with congenital syphilis. Least absolute shrinkage and selection operator regression and multivariable logistic regression showed that age, ethnicity, registered residence, marital status, number of pregnancies, transmission route, the timing of syphilis diagnosis, stage of syphilis, time from first antenatal care to syphilis diagnosis and toluidine red unheated serum test titre were predictors of MTCT of syphilis. A nomogram was developed based on the predictors, which demonstrated good calibration and discrimination with an area under the curve of the receiver operating characteristic of 0.741 (95% CI: 0.728 to 0.755) and 0.731 (95% CI: 0.710 to 0.752) for the derivation and validation cohorts, respectively. The net benefit of the predictive models was positive, demonstrating a significant potential for clinical decision-making. We have also developed a web calculator based on this prediction model.

Our nomogram exhibited good performance in predicting individualised risk for MTCT of syphilis, which may help guide early and personalised prevention for MTCT of syphilis.

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.

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.

This study aims to understand the caregiving experiences of family caregivers of people with schizophrenia in a community.

A qualitative study based on phenomenological analysis was conducted through in-depth interviews.

This study was carried out from May to June 2023 in two community health service centres in urban Beijing, China.

We selected 16 family caregivers for interviews using purposive sampling method.

Four themes and 10 subthemes were identified: (1) psychosocial distress of family caregivers (feeling unprepared and helpless at the beginning, confronting negative emotions in long-term care and straying away from social life); (2) adverse impacts on the whole family (poor cooperation within the family, insufficient family involvement in professional care); (3) coping with family caregiving (accepting the reality of the patients’ illness, struggling with family life balance and having realistic expectations); (4) concerns about future care (daily living support, physical health management).

Family caregivers experienced psychosocial distress and family stress in the process of caregiving. They had to cope with caregiving stress and were concerned about the long-term care of people with schizophrenia. These findings provide implications for intervention programmes to strengthen social support, family involvement, and active coping for caregivers and develop long-term care mechanisms for people with schizophrenia.

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.

Acute heart failure (AHF) is a critical, costly condition with high mortality rates, affecting millions annually. Despite advances in cardiovascular care, AHF treatment lacks robust evidence. AHF commonly manifests with sudden heart failure symptoms such as pulmonary congestion, and the pathophysiology involves fluid overload. Initial treatment is based on intravenous diuretics typically, but the optimal combination of drugs remains uncertain.

We will systematically review randomised controlled trials enrolling patients with AHF and volume overload undergoing in-hospital diuretic treatment. We aim to investigate any diuretic intervention. Our search strategy includes the following databases: Embase, Medline, Latin American and Caribbean Health Sciences Literature, Web of Science and the Cochrane Central Register of Controlled Trials. The primary outcome is all-cause mortality. Secondary outcomes are serious adverse events, hospital readmission and kidney failure. Study results reported at the most extended follow-up will be used for all outcomes. If appropriate, we will conduct meta-analysis, trial sequential analysis and network meta-analysis.

No ethics approval is required for this study. The results will be published in a peer-reviewed journal in this field.

CRD42023463979.

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.

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).

To assess and compare the diagnostic value of contrast-enhanced MRI (CEMRI) and contrast-enhanced CT (CECT) for evaluating the response of hepatocellular carcinoma (HCC) after transarterial chemoembolisation (TACE).

Systematic review and meta-analysis.

PubMed, Embase, the Cochrane Library, CNKI and Wanfang databases were systematically searched from inception to 1 August 2023.

Studies with any outcome that demonstrates the diagnostic performance of CEMRI and CECT for HCC after TACE were included.

Two authors independently extracted the data and assessed the quality of included studies. Study quality was assessed using Quality Assessment of Diagnostic Accuracy Studies-2. The diagnostic performance of CEMRI and CECT for the response of HCC was investigated by collecting true and false positives, true and false negatives, or transformed-derived data from each study to calculate specificity and sensitivity. Other outcomes are the positive likelihood ratio/negative likelihood ratio (NLR), the area under the receiver operating characteristic curve (AUC) for diagnostic tests and the diagnostic OR (DOR). Findings were summarised and synthesised qualitatively according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

This study included 5843 HCC patients diagnosed with CEMRI or CECT and treated with TACE from 36 studies. The mean proportion of men in the total sample was 76.3%. The pool sensitivity, specificity and AUC of CEMRI in diagnosing HCC after TACE were 0.92 (95% CI: 0.86 to 0.96), 0.94 (95% CI: 0.86 to 0.98) and 0.98 (95% CI: 0.96 to 0.99). The pool sensitivity, specificity and AUC of CECT in diagnosing HCC after TACE were 0.74 (95% CI: 0.68 to 0.80), 0.98 (95% CI: 0.93 to 1.00) and 0.90 (95% CI: 0.88 to 0.93).

In conclusion, this study found that both CEMRI and CECT had relatively high predictive power for assessing the response of HCC after TACE. Furthermore, the diagnostic value of CEMRI may be superior to CECT in terms of sensitivity, AUC, DOR and NLR.

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.

To assess the quality of childbirth care and its determinants along the continuum of care in Gondar town public health facility in Ethiopia.

An institution-based, cross-sectional study was employed. Completed data were imported to Stata V.16 for cleaning and analysis. A generalised structural equation model was employed to examine the relationships along the continuum of childbirth care and to determine the factors affecting the quality of childbirth care.

This study was conducted among a total of 865 women who delivered in the public health facility of Gondar, Ethiopia, from 19 May to 30 June 2022.

The study revealed the proportion of good-quality childbirth care during admission, intrapartum and immediate postpartum period was 59% (95% CI 55.7, 62.4), 76.8% (95% CI 73.8, 79.5) and 45% (95% CI 41.7, 48.5), respectively. Postsecondary educational status of mothers (β=0.60, 95% CI 0.16, 1.04) and maternal age of 25–35 (β=0.68, 95% CI 0.33, 1.02) were predictors of quality of care at admission. Referral hospital (β=0.43, 95% CI 0.10, 0.76), presence of guidelines (β=1.36, 95% CI 0.72, 1.99) and provider age of 25–35 (β=0.61, 95% CI 0.12, 1.10) affected the quality of care during the intrapartum period. Urban residence (β=0.52, 95% CI 0.12, 0.93), skilled birth attendant experience (β=0.19, 95% CI 0.11, 0.28) and number of delivery couches (β=–0.29, 95% CI –0.44, –0.13) had significant associations with the quality of childbirth care during the immediate postpartum period.

Although our study found improvements in the quality of childbirth care along the continuum compared with previous studies, more workers are needed to alleviate the problem of poor-quality service. Different maternal, provider and facility factors were found to be predictors of the quality of childbirth care.

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.

Trauma contributes to the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide. In the context of global abdominal trauma, the trauma laparotomy is the most commonly performed operation. Variation likely exists in how these patients are managed and their subsequent outcomes, yet very little global data on the topic currently exists. The objective of the GOAL-Trauma study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management and postoperative outcomes.

We describe a planned prospective multicentre observational cohort study of patients undergoing trauma laparotomy. We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre. The study will collect system, patient, process and outcome data, following patients up until 30 days postoperatively (or until discharge or death, whichever is first). Our sample size calculation suggests we will need to recruit 552 patients from approximately 150 recruiting centres.

The GOAL-Trauma study will provide a global snapshot of the current management and outcomes for patients undergoing a trauma laparotomy. It will also provide insight into the variation seen in the time delays for receiving care, the disease and patient factors present, and patient outcomes. For current standards of trauma care to be improved worldwide, a greater understanding of the current state of trauma laparotomy care is paramount if appropriate interventions and targets are to be identified and implemented.