There are no globally agreed on strategies on early detection and first response management of postpartum haemorrhage (PPH) during and after caesarean birth. Our study aimed to develop an international expert’s consensus on evidence-based approaches for early detection and obstetric first response management of PPH intraoperatively and postoperatively in caesarean birth.

Systematic review and three-stage modified Delphi expert consensus.

International.

Panel of 22 global experts in PPH with diverse backgrounds, and gender, professional and geographic balance.

Agreement or disagreement on strategies for early detection and first response management of PPH at caesarean birth.

Experts agreed that the same PPH definition should apply to both vaginal and caesarean birth. For the intraoperative phase, the experts agreed that early detection should be accomplished via quantitative blood loss measurement, complemented by monitoring the woman’s haemodynamic status; and that first response should be triggered once the woman loses at least 500 mL of blood with continued bleeding or when she exhibits clinical signs of haemodynamic instability, whichever occurs first. For the first response, experts agreed on immediate administration of uterotonics and tranexamic acid, examination to determine aetiology and rapid initiation of cause-specific responses. In the postoperative phase, the experts agreed that caesarean birth-related PPH should be detected primarily via frequently monitoring the woman’s haemodynamic status and clinical signs and symptoms of internal bleeding, supplemented by cumulative blood loss assessment performed quantitatively or by visual estimation. Postoperative first response was determined to require an individualised approach.

These agreed on proposed approaches could help improve the detection of PPH in the intraoperative and postoperative phases of caesarean birth and the first response management of intraoperative PPH. Determining how best to implement these strategies is a critical next step.

To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.

Systematic review.

We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.

Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.

4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.

We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).

Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.

CRD42022282565.

Even when total knee arthroplasty (TKA) is an extended treatment, most patients experience a suboptimal evolution after TKA. The objectives of this study are the following: (1) to determine the effectiveness of two different prosthesis stabilisation systems on the functionality in activities of daily life, and (2) to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers and biomechanical functional evaluation to predict successful evolution.

The PROKnee trial was designed as a randomised controlled patient-blinded trial with two parallel groups that are currently ongoing. The initial recruitment will be 99 patients scheduled for their first TKA, without previous prosthesis interventions in lower limbs, who will be randomly divided into two groups that differed in the stabilisation methodology incorporated in the knee prosthesis: the MEDIAL-pivot group and the CENTRAL-pivot group. The maximum walking speed will be reported as the primary outcome, and the secondary results will be patient-reported questionnaires related to physical status, cognitive and mental state, radiological test, laboratory analysis and biomechanical instrumented functional performance, such as the 6-minute walking test, timed up-and-go test, gait, sit-to-stand, step-over, and ability to step up and down stairs. All the results will be measured 1 week before TKA and at 1.5, 3, 6 and 12 months after surgery.

All procedures were approved by the Ethical Committee for Research with Medicines of the University Clinical Hospital of Valencia on 8 October 2020 (order no. 2020/181). Participants are required to provide informed consent for the study and for the surgical procedure. All the data collected will be treated confidentially since they will be blinded and encrypted. The results from the trial will be published in international peer-reviewed scientific journals, regardless of whether these results are negative or inconclusive.

ClinicalTrials.gov Registry (NCT04850300).

Person-centred care (PCC) is provision of care that is respectful of and responsive to individual patient preferences, needs and values, and ensures that patient values guide all clinical decisions. While there is a large body of evidence on the benefits of PCC in high-income countries, little research exists on PCC in Ghana and Sub-Saharan Africa at large. Most studies on PCC have focused on maternity care as part of the global movement of respectful maternity care. The few studies on patient experiences and health system responsiveness beyond maternal health also highlight gaps in patient experience and satisfaction as well as discrimination in health facilities, which leads to the most vulnerable having the poorest experiences. The protocol for this scoping review aims to systematically map the extent of literature focused on PCC in Ghana by identifying patient expectations and preferences, barriers and facilitators, and interventions.

The protocol will be guided by the Arksey and O’Malley methodological framework and recommendations by Levac et al. A comprehensive search strategy will be used to search for published articles in PubMed, EMBASE, Web of Science and the African Journals Online from their inception to August 2022. Grey literature and reference lists of included studies will also be searched. Two independent reviewers will perform the literature search, eligibility assessments and study selection. Any disagreements will be resolved through discussion with a third reviewer. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram for the scoping reviews will be used to outline the study selection process. Extracted data from the included articles will be synthesised and reported under key concepts derived from the outcomes of the scoping review.

This scoping review does not require ethical approval. The findings will be disseminated through publications and conference presentations.

OSF Registration DOI 10.17605/OSF.IO/ZMDH9.

The WHO Safe Childbirth Checklist (WHO SCC) was developed to accelerate adoption of essential practices that prevent maternal and neonatal morbidity and mortality during childbirth. This study aims to summarise the current landscape of organisations and facilities that have implemented the WHO SCC and compare the published strategies used to implement the WHO SCC implementation in both successful and unsuccessful efforts.

This scoping review protocol follows the guidelines of the Joanna Briggs Institute. Data will be collected and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews report. The search strategy will include publications from the databases Scopus, PubMed, Embase, CINAHL and Web of Science, in addition to a search in grey literature in The National Library of Australia’s Trobe, DART-Europe E-Theses Portal, Electronic Theses Online Service, Theses Canada, Google Scholar and Theses and dissertations from Latin America. Data extraction will include data on general information, study characteristics, organisations involved, sociodemographic context, implementation strategies, indicators of implementation process, frameworks used to design or evaluate the strategy, implementation outcomes and final considerations. Critical analysis of implementation strategies and outcomes will be performed with researchers with experience implementing the WHO SCC.

The study does not require an ethical review due to its design as a scoping review of the literature. The results will be submitted for publication to a scientific journal and all relevant data from this study will be made available in Dataverse.

https://doi.org/10.17605/OSF.IO/RWY27.

During the preschool years, children depend on adult caregivers to provide opportunities for physical activity (PA). Research has focused on measuring PA in preschool, as well as barriers and facilitators to children’s PA but caregiver perceptions remain largely unknown especially in light of the COVID-19 pandemic. This study aims to understand the value of PA in preschool following the pandemic from three types of adult caregivers, parents of a young child (n=7), preschool teachers (n=7) and preschool administrators (n=7).

In-depth qualitative interviews were conducted to explore the following research questions: (a) how do caregivers describe the importance of PA in preschool postpandemic? (b) how do caregivers support and prioritise PA in preschool postpandemic and what challenges do they face in doing so? and (c) how do caregivers interact with one another to promote PA? Qualitative answers were coded using a codebook developed to answer the research questions of interest.

Parents, teachers and administrators all described valuing PA for preschoolers, but each caregiver type described a different way of promoting it. All the caregivers listed barriers that inhibit their ability to prioritise and promote PA, some heightened postpandemic. Lastly, there were limited caregiver interactions when it came to promoting PA, with the burden largely falling on teachers.

Our findings indicate that one particularly important area for intervention is supporting parents, teachers and preschool administrators in creating a shared understanding of the importance of PA for young children and ways to collaborate to promote it.

The reproductive years can increase women’s weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development.

Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m² and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m²), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost–utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants’ experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation.

Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences.

ISRCTN16299220.

Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs.

This multicentre, case–control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.

The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.

NCT03406624.

Fatigue is an important and distressing symptom for many people living with chronic musculoskeletal (MSK) conditions. Many non-pharmacological interventions have been investigated in recent years and some have been demonstrated to be effective in reducing fatigue and fatigue impact, however, there is limited guidance for clinicians to follow regarding the most appropriate management options. The objective of this scoping review is to understand and map the extent of evidence in relation to the factors that relate to the outcome of non-pharmacological interventions on MSK condition-related fatigue across the lifespan.

This scoping review will include evidence relating to people of all ages living with chronic MSK conditions who have been offered a non-pharmacological intervention with either the intention or effect of reducing fatigue and its impact. Databases including AMED, PsycINFO, CINAHLPlus, MEDLINE, EMBASE and Scopus will be searched for peer-reviewed primary research studies published after 1 January 2007 in English language. These findings will be used to identify factors associated with successful interventions and to map gaps in knowledge.

Ethical approval was not required for this review. Findings will be disseminated by journal publications, conference presentations and by communicating with relevant healthcare and charity organisations.

We aimed to provide a comprehensive assessment of health-related quality of life (HRQoL) in patients with rheumatoid arthritis (RA) of different activities and to evaluate the correlation between clinical activity measures and HRQoL instruments. This research also analysed the extent to which different aspects of HRQoL (physical, psychological and social) were affected.

Cross-sectional, observational, non-interventional study.

The study was conducted at the Department of Rheumatology and Immunology, Qilu Hospital, Shandong University.

From December 2019 to October 2020, a total of 340 RA patients participated in the survey using convenient sampling. Three generic instruments, EQ-5D-5L,SF-12 and the AQoL-4D, as well as an RA-specific instrument,the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), were administered to assess patients’ HRQoL. The Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) was used by doctors to measure patients’ clinical activity. Multivariable linear regression was used to compare patients’ HRQoL across different levels of activity. Spearman’s correlation was used to assess the correlation between doctor-reported clinical activity and HRQoL.

A total of 314 patients with RA participated in this study. The mean score of HAQ-DI was 0.87 (SD: 0.91). Using patients in the clinical remission group as a reference, patients in the moderate and high disease activity groups showed significantly reduced health state utility values and HRQoL scores (all ps|=0.50 to 0.65). Among them, the disease-specific instrument had the highest correlation.

RA can have considerable impairment on patients’ HRQoL, both in terms of physical and psychosocial functioning. Given the strong correlation between clinical activity and HRQoL scores, and the fact that HRQoL can be an important clinical supplement. The EQ-5D-5L is probably the most appropriate generic measurement instrument for measuring HRQoL in RA patients.

Gait and mobility impairment are pivotal signs of parkinsonism, and they are particularly severe in atypical parkinsonian disorders including multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). A pilot study demonstrated a significant improvement of gait in patients with MSA of parkinsonian type (MSA-P) after physiotherapy and matching home-based exercise, as reflected by sensor-based gait parameters. In this study, we aim to investigate whether a gait-focused physiotherapy (GPT) and matching home-based exercise lead to a greater improvement of gait performance compared with a standard physiotherapy/home-based exercise programme (standard physiotherapy, SPT).

This protocol was deployed to evaluate the effects of a GPT versus an active control undergoing SPT and matching home-based exercise with regard to laboratory gait parameters, physical activity measures and clinical scales in patients with Parkinson’s disease (PD), MSA-P and PSP. The primary outcomes of the trial are sensor-based laboratory gait parameters, while the secondary outcome measures comprise real-world derived parameters, clinical rating scales and patient questionnaires. We aim to enrol 48 patients per disease group into this double-blind, randomised-controlled trial. The study starts with a 1 week wearable sensor-based monitoring of physical activity. After randomisation, patients undergo a 2 week daily inpatient physiotherapy, followed by 5 week matching unsupervised home-based training. A 1 week physical activity monitoring is repeated during the last week of intervention.

This study, registered as ‘Mobility in Atypical Parkinsonism: a Trial of Physiotherapy (Mobility_APP)’ at clinicaltrials.gov (NCT04608604), received ethics approval by local committees of the involved centres. The patient’s recruitment takes place at the Movement Disorders Units of Innsbruck (Austria), Erlangen (Germany), Lausanne (Switzerland), Luxembourg (Luxembourg) and Bolzano (Italy). The data resulting from this project will be submitted to peer-reviewed journals, presented at international congresses and made publicly available at the end of the trial.

NCT04608604.

There are no data regarding the prevalence of comorbidity (ie, additional conditions in reference to an index disease) and multimorbidity (ie, co-occurrence of multiple diseases in which no one holds priority) in patients with liver cirrhosis. We sought to determine the rate and differences between comorbidity and multimorbidity depending on the aetiology of cirrhosis.

This is a subanalysis of the San MAtteo Complexity (SMAC) study. We have analysed demographic, clinical characteristics and rate of comorbidity/multimorbidity of patients with liver cirrhosis depending on the aetiology—alcoholic, infectious and non-alcoholic fatty liver disease (NAFLD). A multivariable analysis for factors associated with multimorbidity was fitted.

Single-centre, cross-sectional study conducted in a tertiary referral, academic, internal medicine ward in northern Italy (November 2017–November 2019).

Data from 1433 patients previously enrolled in the SMAC study were assessed; only those with liver cirrhosis were eventually included.

Of the 1433 patients, 172 (median age 79 years, IQR 67–84; 83 females) had liver cirrhosis. Patients with cirrhosis displayed higher median Cumulative Illness Rating Scale (CIRS) comorbidity (4, IQR 3–5; p=0.01) and severity (1.85, IQR 16.–2.0; p3 (OR 2.81, 95% CI 1.14 to 6.93, p=0.024) and admission related to cirrhosis (OR 0.19, 95% CI 0.07 to 0.54, p=0.002) were the only significant associations.

Comorbidity is more common in alcohol cirrhosis compared with other aetiologies in a hospital, internal medicine setting.

To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home.

Randomised, parallel design.

Medical wards at six hospital sites in southern Ontario, Canada.

Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks.

Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care.

Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation.

Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62)).

This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial.

NCT02777047.

Although short-term benefits follow parenteral ketamine for treatment-resistant major depressive disorder (TR-MDD), there are challenges that prevent routine use of ketamine by clinicians. These include acute dissociative effects of parenteral ketamine, high relapse rates following ketamine dosing and the uncertain role of psychotherapy. This randomised controlled trial (RCT) seeks to establish the feasibility of evaluating repeated oral doses of ketamine and behavioural activation therapy (BAT), compared with ketamine treatment alone, for TR-MDD. We also aim to compare relapse rates between treatment arms to determine the effect size of adding BAT to oral ketamine.

This is a prospectively registered, two-centre, single-blind RCT. We aim to recruit 60 participants with TR-MDD aged between 18 and 65 years. Participants will be randomised to 8 weeks of oral ketamine and BAT, or 8 weeks of oral ketamine alone. Feasibility will be assessed by tracking attendance for ketamine and BAT, acceptability of treatment measures and retention to the study follow-up protocol. The primary efficacy outcome measure is the Montgomery-Asberg Depression Rating Scale (MADRS) measured weekly during treatment and fortnightly during 12 weeks of follow-up. Other outcome measures will assess the tolerability of ketamine and BAT, cognition and activity (using actigraphy). Participants will be categorised as non-responders, responders, remitters and relapsed during follow-up. MADRS scores will be analysed using a linear mixed model. For a definitive follow-up RCT study to be recommended, the recruitment expectations will be met and efficacy outcomes consistent with a >20% reduction in relapse rates favouring the BAT and ketamine arm will be achieved.

Ethics approval was granted by the New Zealand Central Health and Disability Ethics Committee (reference: 2023 FULL18176). Study findings will be reported to participants, stakeholder groups, conferences and peer-reviewed publications.

UTN: U1111-1294-9310, ACTRN12623000817640p.