Commentary on: MacGregor KA, Ho FK, Celis-Morales CA, et al. Association between menstrual cycle phase and metabolites in healthy, regularly menstruating women in UK Biobank, and effect modification by inflammatory markers and risk factors for metabolic disease. BMC Med. 2023;21:488.
Implications for practice and research Fat mass, physical activity level and cardiorespiratory fitness were identified as factors that influence the relationship between the menstrual cycle and levels of glucose, triglycerides, the triglyceride-to-glucose index, high-density lipoproteins (HDL) and low-density lipoproteins (LDL) cholesterol and the total-to-HDL cholesterol ratio. Future studies should investigate whether these relationships indicate a causal mechanism responsible for the variations in metabolic control throughout the menstrual cycle.
The rate of impaired metabolic regulation is rising among premenopausal women, characterised by decreased insulin sensitivity, increased fasting blood sugar levels and abnormal lipid profiles.
To explore cardiac rehabilitation (CR) professionals’ perspectives on kinesiophobia in patients with cardiovascular diseases. This study aims to understand the perspectives of healthcare professionals (HCPs) regarding their perceptions, assessments and management of kinesiophobia.
A qualitative descriptive study using in-depth interviews and thematic analysis.
The study was carried out through online interviews at a university teaching hospital in South India.
HCPs involved in CR, from around the world, were invited to participate through advertisements on social media and through professional forums. 12 HCPs, including CR nurses (n=1), CR physicians (n=1), cardiac surgeons (n=1), cardiac electrophysiologists (n=1), rehabilitation physicians (n=1), cardiologists (n=2), exercise physiologists (n=2) and physiotherapists (n=3), agreed to participate.
Not applicable (qualitative study without interventions).
Qualitative data collected through in-depth interviews focused on HCP perceptions regarding kinesiophobia and its assessment, management and awareness within CR.
Thematic analysis generated 337 codes, which formed seven subthemes: the perceived burden of kinesiophobia, reasons for kinesiophobia, HCP experiences with kinesiophobia, methods of assessing kinesiophobia, management strategies, reasons why kinesiophobia is overlooked and the importance of promoting awareness of kinesiophobia.
CR professionals recognise kinesiophobia as a significant issue among patients with heart disease but do not recognise the term or perceive it as a separate condition; instead, they view it as part of the overall clinical presentation. There is a strong need to advocate for early recognition and assessment of kinesiophobia and for the development of structured management strategies and its inclusion into CR programmes to improve patient outcomes during recovery.
The study was prospectively registered in the Clinical Trial Registry of India (CTRI/2022/05/042502). This study received approval from the Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) with reference number IEC2:13/2022.
Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.
We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.
The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.
In the last 60 years, newborn bloodspot screening (NBS) has expanded as a public health intervention from a single severe childhood genetic disease (SCGD) to up to as many as 80 SCGD and testing of ~40 million newborns/year worldwide. However, the gap between current NBS and its potential to increase the efficiency, effectiveness and global equity of healthcare delivery for SCGD is large and rapidly growing. There are now effective therapeutic interventions—drugs, diets, devices and surgeries—for up to 2000 SCGD. Since almost all SCGD can be identified by bloodspot genome sequencing, it has been a longstanding goal to supplement current NBS with genome sequencing-based NBS (gNBS) for all eligible SCGD. We recently described a novel gNBS platform (named Begin Newborn Genome Sequencing (BeginNGS)) with the potential to overcome several major challenges to gNBS (cost, scalability, false positives and an unprepared healthcare workforce). A pilot clinical trial of BeginNGS for 412 SCGD in a level IV neonatal intensive care unit (NICU) had a true positive rate of 4.2%, sensitivity of 83%, positive predictive value of 100% and clinical utility rate of 4.2%, indicating readiness of the platform for use in a powered, multicentre study.
The BeginNGS study is a single group, international, multicentre, adaptive clinical trial to compare utility, acceptability, feasibility and cost-effectiveness of BeginNGS gNBS (experimental intervention) with standard NBS (control). A minimum of 10 000 neonates (aged 50 000 US children per year.
This study was approved by the WCG Clinical institutional review board on 14 February 2024, and the most recent amendment approved on 7 October 2025 (approval number 20235517). Study findings will be shared through research consortium workshops, national and international conferences, community presentations and peer-reviewed journals.
Dysregulated immunity may account for an increased risk of infection and other adverse outcomes among frail hospitalised persons. The primary objective of this study is to examine whether baseline frailty is associated with the risk of developing ventilator-associated pneumonia (VAP) or other intensive care unit (ICU)-acquired infections among invasively ventilated adults. Additional objectives are to examine the relationship between frailty and hospital length of stay, discharge to a long-term care facility and vital status. We hypothesise that persons with frailty compared with others would have an increased risk of VAP and other infections, a longer hospital stay, higher probability of discharge to a long-term care facility and higher mortality.
This is a preplanned secondary analysis of the PROSPECT trial (
Participating hospital research ethics board approved the PROSPECT trial and data collection. The protocol for this study was approved by the Hamilton Integrated Research Ethics Board on 20 August 2015 (Project ID:19128). This study will identify whether frailty is associated with risk of VAP and other healthcare-associated infections in invasively ventilated patients, adjusted for other baseline factors. Results may be useful to patients, their caregivers, clinicians and the design of future research. Findings will be disseminated to investigators at a meeting of the Canadian Critical Care Trials Group. We will present study results at an international conference in the fields of critical care and infectious diseases, to coincide with or precede open-access peer-review publication. To aid knowledge dissemination, we will use a variety of formats. For example, for traditional and social media, we will create two different visual abstracts and infographics of our results suitable to share on clinician-facing and public-facing platforms.
Adolescent pregnancy is a global issue. Early childbearing is strongly linked to poverty and negative health outcomes, including increased neonatal death risk. This study explores spatial patterns of adolescent pregnancies and neonatal deaths and their association with socioeconomic characteristics.
This population-based study used spatial analysis techniques to investigate the geographical distribution of adolescent pregnancies, socioeconomic characteristics and neonatal mortality rate (NMR).
The 645 municipalities of State of Sao Paulo, Brazil.
All live births to mothers residing in the State of Sao Paulo, Brazil, between 2004 and 2020.
The socioeconomic indicators used were: municipal human development index and per capita income (PCI). Spatial patterns were assessed for spatial autocorrelation (Moran’s I, LISA), and smoothed using local Bayesian estimation. Spearman’s correlation was used to ascertain the relationship between the percentage of live births to adolescent mothers and socioeconomic indexes. This calculation was also undertaken between different maternal age groups of NMR.
The study analysed over 10 million live births, with 14.3% attributed to adolescent mothers. Spatial analysis revealed significant clustering of adolescent pregnancies, strongly associated with lower socioeconomic indicators. NMR also exhibited spatial clustering, particularly after smoothing. Statistically significant differences were observed in PCI medians between high–high and low–low clusters for adolescent births. High and low incidence areas of NMR, both in all maternal ages and stratified by adolescent and non-adolescent mothers, demonstrated considerable overlap.
The results indicated the existence of clustering areas of adolescent pregnancy and neonatal deaths and suggested that the prevalence of births to adolescent mothers is not distributed equally and is higher in lower socioeconomic developed areas.
In response to the high maternal mortality in Afghanistan, the government emphasised enhancing antenatal care (ANC) coverage to improve skilled birth attendance and reduce maternal mortality. This study aimed to explain how and why ANC interventions worked, for whom, and under what circumstances in Afghanistan between 2000 and 2024.
A rapid realist review was conducted to identify underlying programme theories and examine contextual factors and key mechanisms influencing ANC outcomes, with input from a panel of national experts. Data were extracted using context–mechanism–outcome (CMO) configurations to develop and refine theories for policy recommendations.
From 3502 papers, 1860 duplicates were removed, 63 were screened for full text and 25 were included in the final review. In total, 29 CMOs were inferred across nine interventions, classified at individual, interpersonal, community and institutional levels. We found that ANC interventions could work best by empowering women and healthcare workers (HCWs), involving husbands, hiring female community health workers (CHWs), ensuring regular contact with the same HCWs, endorsing health messages by the government, incentivising CHWs and designing and implementing interventions using participatory approaches. Interventions are less successful when there is a lack of community trust in service quality or HCW qualifications, low decision-making ability among women, discomfort during travel to health facilities, adherence to traditional practices and beliefs, hiring CHWs from outside the community, chronic stress and lack of support among HCWs and unrecognised incentives.
Our evidence synthesis can inform donors, policymakers and implementers on how to design more effective ANC interventions to achieve better health outcomes in Afghanistan. By emphasising intervention evaluation and ANC quality improvement, it highlights the importance of key social elements, such as cultural norms, power dynamics, relationships, beliefs and trust, which are likely to maximise impact. Community involvement is essential for designing and implementing effective and sustainable ANC interventions.
Oral health research provides evidence for policy and practice, yet no study has comprehensively mapped the scope of oral health research in Malaysia. The COVID-19 pandemic has also created a great impact on oral healthcare in Malaysia, including the dental care delivery. Additionally, there is a notable lack of research focusing on oral health during and after the COVID-19 pandemic. Therefore, this scoping review will aim to map the landscape of oral health research conducted in Malaysia and identify key topics, study designs, populations studied and gaps in the literature, in order to inform future research priorities and policy, particularly in the post-COVID-19 era.
The methodology draws on Arksey and O’Malleys’ seminal framework for the scoping review and will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Review (PRISMA-ScR) guidelines. We will search five major electronic databases—PubMed, Scopus, ProQuest, Cochrane and Web of Science—as well as selected grey literature sources (eg, theses, dissertations and conference proceedings) for studies published in English from January 2014 to December 2024. Studies of any design related to oral health in Malaysia will be included. Two reviewers will be performing title and abstract screening, in which they will be working independently. The included publication will undergo a full-text review, and references cited in these studies will be examined following the inclusion criteria. The PRISMA-ScR flow diagram will be used as a guide throughout the process. Data will be extracted, analysed and charted according to key categories identified in the included publications. A narrative synthesis and descriptive statistics will be presented.
The results of this scoping review will illustrate an overview and provide a better understanding regarding the oral health research in the Malaysian context; whether research has already been conducted, is currently ongoing and is still needed; and which areas should be prioritised for future investigation. As this review will use publicly available literature, formal ethics approval will not be required. The findings will be submitted for publication in an open-access peer-reviewed journal, presented at national and regional conferences and shared with Malaysian dental professional bodies and relevant stakeholders.
The protocol of this scoping review is registered with the Open Science Framework and is available at osf.io/hjq6m.
To adapt the Serious Illness Conversation Guide (SICG), Ariadne Labs, Massachusetts USA, to a local Singapore version and evaluate its acceptability.
Qualitative study using semistructured interviews.
49 participants (30 patients with serious illnesses, five family caregivers and 14 healthcare providers (HCP)) recruited from three public hospitals in Singapore.
Face-to-face or virtual indepth interviews.
Guided by the Heuristic Framework and Cultural Sensitivity model, we employed a multi-stage iterative design. Starting with the original SICG, we iterated the guide following three rounds of cognitive interviews among patients followed by expert consultation (n=4) to derive a local version, subsequently reviewed by caregivers and HCP. We assessed acceptability of the SICG using traffic light colour codes—red (unacceptable), orange (needs change) and green (no change) and gathered suggestions to rephrase them. Using content analysis, we compared acceptability of questions as proportion of red, orange and green responses at each interview round and inductively derived themes reflecting views towards the guide.
The original SICG showed low acceptability, and most questions received high proportions of red responses. Negative words and phrases dampening hope, lack of comprehension due to complex framing and cultural insensitivity to prognostic discussions were key themes reflecting low acceptability. Surface and deep structural revisions that centred around positive framing with hopeful language, focusing on current values and individualising conversations (‘use if appropriate’ prompts) significantly improved the guide’s acceptability.
We derived a local Singapore SICG that aligns with the core elements of the original guide and fosters cultural sensitivity. The adapted version could be further tested in other Asian countries.
Progress at the intersection of artificial intelligence and paediatric neuroimaging necessitates large, heterogeneous datasets to generate robust and generalisable models. Retrospective analysis of clinical brain MRI scans offers a promising avenue to augment prospective research datasets, leveraging the extensive repositories of scans routinely acquired by hospital systems in the course of clinical care. Here, we present a systematic protocol for identifying ‘scans with limited imaging pathology’ through machine-assisted manual review of radiology reports.
The protocol employs a standardised grading scheme developed with expert neuroradiologists and implemented by non-clinician graders. Categorising scans based on the presence or absence of significant pathology and image quality concerns facilitates the repurposing of clinical brain MRI data for brain research. Such an approach has the potential to harness vast clinical imaging archives—exemplified by over 250 000 brain MRIs at the Children’s Hospital of Philadelphia—to address demographic biases in research participation, to increase sample size and to improve replicability in neurodevelopmental imaging research. Ultimately, this protocol aims to enable scalable, reliable identification of clinical control brain MRIs, supporting large-scale, generalisable neuroimaging studies of typical brain development and neurogenetic conditions.
Studies using datasets generated from this protocol will be disseminated in peer-reviewed journals and at academic conferences.
Engaging patients in surgical safety is challenging and has not been thoroughly investigated. Although surgical checklists and other safety protocols have been introduced across various surgical fields, preventable adverse events still occur, highlighting the need for additional research. A Patient’s Safety Checklist (PASC) has been developed and validated for use by surgical patients. Its effect on patient safety and patient outcomes is currently being investigated in a Stepped Wedge Cluster Randomised Controlled Trial (NCT03105713). In connection with this trial, we have examined elective patients’ experiences with using the PASC.
An exploratory qualitative study was conducted based on individual in-depth telephone interviews with 31 elective surgical patients. The interviews were carried out across three Norwegian hospitals including seven surgical specialties. The patients interviewed were part of the trial’s intervention arm and had used PASC. The interviews were transcribed verbatim, and reflective thematic analysis was applied.
Three themes were identified in the data: patient awareness, patient actions and utility value. Patients perceived PASC to increase awareness around surgical information, preparations, what to speak up about and which information to seek and repeat. This awareness led to a series of actions, such as ensuring medication control, optimising their own health, contacting healthcare professionals, asking questions, and for some no actions were needed. Patients perceived PASC to have high utility value for their surgical preparation.
The PASC enhanced patients’ involvement in surgical care and safety by ensuring they received systematic, accurate, clear, and understandable information and instructions throughout the surgical pathway. It is one of the few existing interventions that specifically focuses on assisting patients in preparing for surgery and managing their recovery. Further research is needed on the implementation of PASC and its adaptation to other clinical settings.
Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities.
The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement.
As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.
Early and balanced replacement of blood products appears to be the key factor in improving outcomes of major bleeding patients including acute trauma, cardiac, obstetric and transplant surgery patients. Definitive clinical guidance regarding the optimal ratio of blood products, including those containing fibrinogen, is still lacking. Therefore, we tested the hypothesis that increasing the fibrinogen content to erythrocyte suspension ratio improves the mortality and functional outcomes of patients undergoing surgeries with expected major bleeding.
The Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) ratio is a multicentre, prospective, observational, cohort study of patients undergoing major surgical procedures with expected major perioperative bleeding (ie, requiring packed red blood cells (PRBC)>4U/24 hours). For 5U of cryoprecipitate and 1.5 U of fresh frozen plasma (FFP), the approximate dose-equivalent for fibrinogen is considered as 1 gram of fibrinogen. Association of the ADEFES ratio at 24 hours will be assessed on the primary objective, which will consist of the composite of 30-day all-cause mortality, 30-day bleeding-specific mortality and the ‘highly-dependent scores’ of Katz index of independence in activities of daily living.
The study protocol was approved by the Ethics Committee of Ankara Bilkent City Hospital (approval no. E2-23-4265, dated 07 June 2023; Chair: Prof. Dr. F.E. Canpolat) and by the institutional review boards of all participating centres. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Strengthening the Reporting of Observational Studies in Epidemiology guidelines, as well as in compliance with national regulations on data protection and Good Clinical Practice standards. Written informed consent will be obtained from all participants prior to inclusion in the study.
The results of this study will be disseminated through peer-reviewed scientific journals, presentations at national and international conferences, and communication with relevant stakeholders including clinical practitioners and healthcare institutions. If applicable, study outcomes will also be shared via institutional newsletters and digital platforms to reach a broader audience in the medical community.
The Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART) study is a prospective cohort study aiming to explore health outcomes in mothers and children following assisted reproductive technology (ART), with a particular focus on frozen embryo transfer (FET) versus fresh embryo transfer (fresh-ET). The increasing prevalence of ART and FET emphasises the need to assess potential health risks associated with the procedures, both in pregnancy, such as pre-eclampsia and large for gestational age offspring, and in the children, such as obesity and cardiometabolic dysfunction.
The cohort will include 600 pregnant women, their potential partner and their offspring in a 1:1:1 ratio of pregnancies achieved after ART with FET, ART with fresh-ET and women who conceived naturally. The study will involve extensive data collection from electronic medical records; parental questionnaires; biochemical, genetic and epigenetic analyses in blood, urine and placental tissue; and medical imaging (fetal ultrasound and PEA POD scan) and clinical examinations. Outcomes are grouped into six work packages (WPs) related to fetal growth (WP1), pregnancy (WP2), placenta (WP3), offspring (WP4), genetics (WP5) and epigenetics (WP6).
The COMPART study aims to provide valuable insights into the impact of ART and FET on maternal and offspring health and the underlying mechanisms responsible. The study seeks to advance reproductive medicine, shape clinical practice and guidelines and ultimately ensure maternal-fetal health following ART. The study has been approved by the Danish Ethics Committee (H-23071266; February 2024).
Patient engagement (PE), or a patient’s participation in their healthcare, is an important component of comprehensive healthcare delivery, yet there is not an existing, publicly available, measurement tool to assess PE capacity and behaviours. We sought to develop a survey to measure PE capacity and behaviours for use in ambulatory healthcare clinics.
Measure development and psychometric evaluation.
A total of 1180 adults in the USA from 2022 to 2024, including 1050 individuals who had indicated they had seen a healthcare provider in the prior 12 months who were recruited nationally via social media across three separate samples; 8 patient advisors and healthcare providers recruited from a large, midwestern US Academic Medical Center; and 122 patients recruited from five participating ambulatory clinics in the Midwestern USA.
An initial survey was developed based on a concept mapping approach with a Project Advisory Board composed of patients, researchers and clinicians. Social media was then used to recruit 540 participants nationally (Sample 1) to complete the initial, 101-item version of the survey to generate data for factor analysis. We conducted exploratory and confirmatory factor analyses to assess model and item fit to inform item reduction, and subsequently conducted cognitive interviews with eight additional participants (patient advisors and providers; Sample 2), who read survey items aloud, shared their thoughts and selected a response. The survey was revised and shortened based on these results. Next, a test–retest survey, also administered nationally via another round of social media recruitment, was administered two times to a separate sample (n=155; Sample 3), 2 weeks apart. We further revised the survey to remove items with low temporal stability based on these results. For clinic administration, research staff approached patients (n=122; Sample 4) in waiting rooms in one of five ambulatory clinics to complete the survey electronically or on paper to determine feasibility of in-clinic survey completion. We engaged in further item reduction based on provider feedback about survey length and fielded a final revised and shortened survey nationally via a final round of social media recruitment (n=355; Sample 5) to obtain psychometric data on this final version.
Cronbach’s alphas, intraclass correlations (ICCs), Comparative Fit Index (CFI), root mean square error of approximation (RMSEA), standardised root mean squared residual (SRMR).
The final PE Capacity Survey (PECS) includes six domains across two scales: ‘engagement behaviours’ (ie, preparing for appointments, ensuring understanding, adhering to care) and ‘engagement capacity’ (ie, healthcare navigation resources, resilience, relationship with provider). The PECS is 18 questions, can be completed during a clinic visit in less than 10 minutes, and produces scores which demonstrate acceptable internal consistency reliability (α=0.72 engagement behaviours, 0.76 engagement capacity), indicating items are measuring the same overarching construct. The scales also had high test–retest reliability (ICC=0.82 behaviours, 0.86 capacity), indicating stability of response over time, and expected dimensionality with high fit indices for the final scales (behaviours: CFI=0.97; RMSEA=0.07; SRMR=0.05; capacity: CFI=0.99; RMSEA=0.06; SRMR=0.06), indicating initial evidence of construct validity.
The PECS is the first known measure to assess patients’ capacity for engagement and represents a step toward informing interventions and care plans that acknowledge a patient’s engagement capacity and supporting engagement behaviours. Future work should be done to validate the measure in other languages and patient populations, and to assess criterion-related validity of the measure against patient outcomes.
Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.
A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.
Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by 2 tests or the Kruskal-Wallis test.
The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.
NCT06916598 (clinicaltrials.gov).
Many adolescent girls experience body dissatisfaction and have low levels of physical activity. Secondary school physical education (PE) offers opportunities for girls to build self-confidence and stay active; however, PE uniforms can be a barrier to participation.
To explore how secondary school PE uniform policies influence body image attitudes and PE engagement (participation and enjoyment) among adolescent girls, and how these policies could be co-developed in future.
A qualitative study involving focus groups and interviews.
Forty-four 12–13 year-old girls and six PE staff members from six mixed-sex secondary schools in England.
Using topic guides and participatory activities to aid discussions, we explored PE uniform preferences and the influence on body image attitudes and PE engagement with adolescent girls, as well as the PE uniform policy development process with PE staff. Data were analysed using reflexive thematic analysis, supported by NVivo V.14.
Three themes were generated. Theme 1, ‘Striking the right balance between choice, comfort and uniformity’, describes the challenges of developing PE uniform policies that offer pupils choice to maximise comfort, while maintaining uniformity to ensure smartness, and to reduce social comparison. Theme 2, ‘PE uniforms are "made for boys"’ reflects that current policies can often provide unisex uniforms that do not fit the female body, or gendered options that limit girls’ choices over style and fit. Theme 3, ‘Self-confidence influences comfort in wearing PE uniform, and in turn PE engagement’ suggests girls with high self-confidence may be less concerned about others’ opinions and how they look, leading to greater PE enjoyment, whereas girls with lower self-confidence described feeling self-conscious, especially in communal changing rooms, which could impact their comfort and PE engagement.
Our findings suggest that developing PE uniform policies, which allow pupils to choose their own bottoms, wear additional layers and wear PE uniform all day may improve comfort and inclusivity among girls, facilitating better PE engagement.
Various psychological, cognitive, behavioural, medication and neurostimulation treatments can improve the outcomes of people with depressive and anxiety disorders. However, in usual practice, there is large variability in treatment delivery and treatments are poorly characterised. The effectiveness and quality of mental health services in the community are not accurately monitored and are poorly understood. At present, healthcare organisations, payers and policy makers know little about the quality of care they support. Similarly, patients and families have limited information on quality to guide choice of provider or organisation. It will be necessary to implement monitoring of treatment quality so that treatment and outcomes can be improved. This study develops, tests and validates a new, transdiagnostic outcome-focused mental health quality measure. This measure is based on routine, regular patient reports of their symptoms. It is designed to be aggregated at the provider, clinic, organisation or plan level; inform choice of provider; and be used to improve routine delivery of services and quality of care among patients with common psychiatric disorders.
The project analyses existing data with responses to a wide variety of items that are known to assess depression or anxiety and empirically selects symptom items for a transdiagnostic outcome-focused quality measure. The project informs risk adjustment and benchmarking of the quality measure by studying how patient, provider and practice factors, including health-related social needs, baseline symptom severity and diagnoses, affect outcomes. Drawing on these, the project specifies an outcome-focused quality measure that includes risk adjustment and benchmarks for improvement; and studies, at practices nationally, its feasibility and psychometric properties, the effect of treatment characteristics on the quality of care, and the effect of quality on health-related quality of life.
Results will be published. The quality measure is designed to be broadly relevant across community settings and populations and to be submitted for endorsement by regulatory and governing bodies.
Patient-centred care (PCC) is one of the six key attributes of healthcare quality. However, despite its significant contribution to improving healthcare quality, PCC is often poorly implemented. This study aimed to explore the determinants of effective PCC implementation among healthcare providers at Kahama Municipal Hospital in Tanzania.
To explore the determinants influencing the effective implementation of PCC among healthcare providers at Kahama Municipal Hospital in Tanzania.
A qualitative approach was used, with 21 healthcare providers recruited through purposive and convenience sampling methods. Data were collected through focus group discussions and key informant interviews, and content analysis was employed to analyse the data.
The study was conducted at Kahama Municipal Hospital, in the Kahama Municipal Council of the Shinyanga region, Tanzania, from February to June 2019. As a referral hospital, Kahama Municipal Hospital serves a vast catchment area, including rural and semiurban communities across more than eight regions in Tanzania’s Lake and Western zones.
The study identified several factors related to healthcare professionals, including awareness of PCC, staff motivation, heavy workload, professional competencies and effective communication. Organisational-related determinants, such as the absence of ethical guidelines, a lack of a clear organisational culture and the absence of specific policies and guidelines on PCC, were also found to affect its effective implementation.
PCC is recognised at Kahama Municipal Hospital, but key barriers hinder its implementation, including unclear policies, lack of a PCC-focused vision, staff shortages, excessive workloads, low motivation, limited practical exposure and communication issues. To improve PCC implementation, healthcare policymakers and hospital administrators should: (1) establish clear PCC policies, (2) integrate a patient-centred vision into leadership, (3) address workforce shortages, (4) provide targeted training on PCC and (5) boost staff motivation through recognition and career development. Implementing these measures will improve care quality and health outcomes. Further large-scale research is needed to assess PCC implementation across Tanzania and guide national policy.
Patient-centred care (PCC) is associated with better experiences for chronic care encounters and better outcomes. However, its assessment and resultant management outcomes have not been well documented in Malawi. As Malawi strives to institutionalise PCC in its quality-of-care initiatives, documenting its correlates and outcomes is a good starting point in the implementation and advocacy of PCC among chronic care patients, particularly those living with diabetes mellitus (DM).
We sought to assess the level of diabetic patients’ perception of PCC and its relationship to self-efficacy, adherence and glycaemic control among patients with DM.
This study was done in DM clinics of two district and two central hospitals in southern Malawi.
This was a cross-sectional analytical study. We studied 607 subsequent consenting adult patients with DM. We assessed the level of perception of using a locally generated and validated tool and its correlation with self-efficacy, adherence and long-term glycaemic control after a medical encounter. We used K-means clustering, linear and logistic regression, and path analysis in the analysis.
The study’s outcome measures included adherence, self-efficacy, long-term glycaemic control. Adherence included aspects related to medication, diet, lifestyle and appointment keeping and was assessed using the Hill-Bone tool. Self-efficacy was assessed using a Stanford self-efficacy tool while long-term glycaemic control was determined through haemoglobin A1c (HbA1c) point-of-care testing.
Overall, the mean score for PCC was 62.86 (SD 14.78). The study highlighted two groups of patients with statistically distinct mean scores of 51.6 (7.8) vs 77.1 (7.2) out of a possible 92 (p
Although this study did not find a direct correlation between PCC and glycaemic control, it has demonstrated that PCC medical encounters could potentially improve glycaemic control by enhancing patients’ adherence to their diabetes management plans. Even though PCC is not an end in itself, medical encounters that prioritise good relational ambience, patient involvement and capacitation are promising interventions in DM care, especially for patients with or at risk of DM complications. The general lack of patient individualisation and involvement elements found in the medical encounters in our study could explain why PCC hardly has an impact on self-efficacy. The study highlights the importance of PCC in DM patient management and outlines important innovative adaptations towards transforming medical education to equip and appraise interpersonal skills that have an impact on patient-reported experiences and outcomes.