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Global prevalence and determinants of hospital-acquired COVID-19: protocol for a systematic review and meta-analysis

Por: Ribaric · N. L. · ONeill-Byrne · Z. · Hellinger · A. · Pan · D. · Wilson · N. M. · Viola · I. M. · Walsh · T. S. · Lawton · T. · Afanasjevs · S. · Calabria · C. · De Angelis · F. · Brehm · T. T. · Zapf · A.
Introduction

A proportion of patients hospitalised for COVID-19 acquire the disease during their hospital stay, underscoring the risk of hospital-acquired COVID-19 (HA-COVID-19). This risk is presumed to be high, given how commonly and intensely air and surfaces within hospitals are reportedly contaminated with SARS-CoV-2. However, the true extent of HA-COVID-19 worldwide remains unknown, with limited understanding of factors that influence its occurrence and how these have evolved over time. This review will therefore aim to estimate the pooled prevalence of HA-COVID-19 among hospitalised COVID-19 patients globally and investigate differences by country, type of hospitals, medical specialty, length and timing of studied periods.

Methods and analysis

A systematic review and meta-analysis will be conducted adhering to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. MEDLINE and PubMed Central (via PubMed), Scopus, Embase (via Ovid), the Web of Science Core Collection as well as websites of public health agencies (PHA) will be searched until 1 July 2026. All journal articles and sources from PHAs reporting any primary data on the prevalence of HA-COVID-19 will be included. Methodological quality will be assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Studies Reporting Prevalence Data. The primary outcome will be the global prevalence of HA-COVID-19. Data synthesis will include random-effects proportional meta-analysis. Estimates will be presented with two-sided 95% CIs and heterogeneity assessed using the I² statistic.

Ethics and dissemination

Ethical approval is not needed as no original data will be generated. This review will be published in an international, peer-reviewed journal.

PROSPERO registration number

CRD420251136884.

Oral probiotics and topical secretome to enhance clinical outcomes and microbiome restoration in acne vulgaris: a double-blind, randomised controlled trial protocol

Por: Lestari · K. · Sutema · I. A. M. P. · Latarissa · I. R. · Oon · S. F. · Tamsir · N. M. · Noor · A. · Widowati · I. G. A. R. · Sartika · C. R. · Ciptasari · N. W. E.
Background

Acne vulgaris is a chronic inflammatory condition primarily caused by Cutibacterium acnes, which disrupts skin homeostasis, thereby triggering immune responses and sebum metabolism. Dysbiosis is an imbalance in the skin and gut microbiota identified as a significant factor contributing to acne progression. Standard therapy often relies on antibiotics, but the long-term use has increased antibiotic resistance, including in Indonesia. Consequently, alternative methods, such as probiotics and mesenchymal stromal cell secretomes, are gaining attention for immunomodulatory and regenerative properties. These novel therapies have shown promising results in modulating the skin and gut microbiota while reducing inflammation.

Methods and analysis

A phase 2 double-blind randomised controlled trial will be conducted using a parallel group design with four arms, namely: (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Sixty-four patients with mild to moderate acne vulgaris will be randomly allocated to these groups. Interventions will be administered over a period of 8 weeks, with outcomes to be measured at baseline and post-therapy. This study will be conducted at the Dermatology and Venereology Department of Bali Mandara General Hospital (RSBM). The primary outcome will be the reduction of comedones and inflammatory lesions, assessed using the Yolov8 method. Secondary outcomes will include gut and skin health parameters, such as tryptophan metabolites, collagen, pH, moisture, sebum levels and IL-6, to explore the relationship between microbiome balance, skin condition and inflammation in acne.

Ethics and dissemination

This study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and the International Conference on Harmonisation–Good Clinical Practice guidelines. Ethical approval has been granted by the Health Research Ethics Committee of Bali Mandara Regional Hospital (Approval Reference Number: 060/EA/KEPK.RSBM.DINKES/2024). All participants will provide written informed consent prior to enrolment. Data confidentiality and participant safety will be upheld throughout the trial. The results of this study will be disseminated through journals, scientific conferences and relevant academic platforms to ensure wide accessibility and to support further research and clinical application in the field of dermatology, particularly in addressing antibiotic resistance and microbiome-based acne therapies.

Trial registration number

NCT06925386.

Three delays of malaria care-seeking in Malawi: a cross-sectional study

Por: Olapeju · B. · Bride · M. · Volkmann · T. · Cash · S. · Dembo · E. · Kayange · M. · Gumbo · A. · Mafuleka · T. · Boyle · J. · Mangando · A. · Mbeye · N. M. · Mukwakwa · C.
Objective

To identify psychosocial and structural barriers to prompt malaria care-seeking in Malawi by applying the Three Delays Model (delay 1: deciding to seek care; delay 2: reaching a facility; delay 3: receiving quality care).

Design

cross-sectional study.

Setting

Nationally representative data collected from Malawi communities between 25 May 2021 and 1 July 2021.

Participants

913 female caregivers who reported a child with fever in the past 2 weeks.

Primary outcome measures

Prompt care-seeking for fever (same or next day) from a qualified health provider.

Results

Prompt care-seeking was primarily associated with delay 1 (adjusted OR (aOR) 0.58, 95% CI 0.43 to 0.78) and psychosocial (aOR 0.59; 95% CI 0.44 to 0.79) factors. Significant factors included incorrect knowledge of malaria symptoms, cause and diagnosis (aOR 0.71: 95% CI 0.53 to 0.97), negative attitudes towards care-seeking (aOR 0.58; 95% CI 0.41 to 0.82), incorrect knowledge of when and where to seek care (aOR 0.19: 95% CI 0.07 to 0.50) and far distance from a health facility (aOR 0.67, 95% CI 0.49 to 0.93).

Conclusion

Despite the availability of free malaria services, significant bottlenecks remain in the initial decision-making phase. To reduce malaria mortality, national programmes should prioritise social and behaviour change interventions that move beyond general awareness to target specific care-seeking attitudes and intra-household decision-making dynamics.

Effectiveness of an anti-inflammatory diet intervention and cognitive behavioural therapy in endometriosis: protocol for a randomised controlled clinical trial

Por: Huijs · E. · van der Sman · L. · Wirken · L. · Delcliseur · H. S. · Winter · E. G. · de Roos · N. M. · van der Molen · R. G. · Oosterman · J. M. · Vigano · P. · Horne · A. W. · Dolmans · M.-M. · Hoogstad-van Evert · J. S. · Nap · A. W. · EUmetriosis Working Group
Introduction

Treatment for women with endometriosis is only partially or temporarily effective. Moreover, medical hormonal treatment is associated with debilitating side effects and interferes with fertility, while surgery has a relatively high risk of complications. Meanwhile, women with endometriosis show increasing interest in implementing lifestyle interventions to alleviate symptoms and improve health-related quality of life (HRQoL). Integrating these lifestyle interventions can provide a holistic approach to the treatment of this debilitating disease. However, scientific evidence supporting the effectiveness of these interventions is limited. This study is designed to investigate the effectiveness of two lifestyle interventions and the combination of both: an anti-inflammatory diet intervention (AIDI) could improve immune cell function and reduce inflammation, resulting in improved HRQoL and alleviating pain. In addition, the integration of cognitive behavioural therapy (CBT) aims to provide insight into pain mechanisms and coping with pain, and to assist in sustaining dietary adjustments.

Methods and analysis

The Pain in Endometriosis And the Relation to Lifestyle (PEARL) study is a five-arm randomised controlled trial with a pre-post factorial design with two factors: an AIDI and CBT. The study population will consist of 250 premenopausal women, of whom 200 are diagnosed with endometriosis and experience pain symptoms and 50 are healthy controls (HC). Women with endometriosis will be recruited from one academic tertiary and five secondary hospitals in the Netherlands. They will be randomised (1:1:1:1) among four intervention groups: standard care (SC) (SC group), SC and an AIDI (SC + AIDI group), SC and CBT (SC + CBT group), and SC, AIDI and CBT (SC + AIDI + CBT group). Women with endometriosis will visit the hospital twice during the intervention period, at the start (T0) and end (T2) of the 13-week intervention period. HC will not undergo any of the interventions and will have one hospital visit (T0). Participants will complete questionnaires regarding pain symptoms, HRQoL, physical activity level, sleep, diet quality, pain cognitions, and stress at T0 and T2. Furthermore, they are instructed to collect menstrual effluent, a vaginal swab and a faecal sample. During the study visits, peripheral blood will be drawn and scalp hair samples will be taken. The primary outcome is average pain, measured using a numerical rating scale. Secondary outcomes focus on HRQoL, inflammation, immune system characteristics, vaginal- and gut microbiome, and hair cortisol levels. These are considered to reflect potentially underlying mechanisms of the effect of both interventions on the primary outcome. Biological samples and questionnaires of women with endometriosis and HC will be compared to establish the differences in secondary outcomes.

Ethics and dissemination

This study protocol has been approved (approval number: NL86247.091.24) by the METC Oost-Nederland from Radboud University Medical Centre on July 11, 2024. Prior to participation, participants are required to provide informed consent. The results will be widely disseminated through scientific peer-reviewed journals, and presentation to a broad audience in scientific meetings, congresses, patient meetings, as well as in policy-relevant forums.

Trial registration number

NCT06332560.

Strategies to increase HPV vaccination among unvaccinated college students in the USA: a concept mapping study

Por: Mantina · N. M. · Palmer · K. N. B. · Yusoof · K. A. · Rajkumar · T. · Magrath · P. A. · Barraza · L. · Madhivanan · P.
Objective

The goal of this study was to identify strategies and assess priorities to increase human papillomavirus (HPV) vaccination among unvaccinated young adults using a concept mapping approach.

Design

The concept mapping process was conducted in two phases. In phase 1, eligible participants generated qualitative statements in response to a topic prompt. In phase 2, participants organised and grouped the statements by perceived similarity, and then rated each statement on a scale of perceived effectiveness. Multidimensional scaling and hierarchical cluster analysis were conducted to develop a conceptual map of the data.

Setting

This study was conducted at a university in the southwestern USA.

Participants

Eligibility criteria for participation included individuals (1) aged 18–26, (2) who had not received any dose of the HPV vaccine or were unsure if they had received the vaccine and (3) who were enrolled students at the study site institution. 24 participants engaged in the concept mapping process; five participated in phase 1 only, five participated in phase 2 only and 14 participated in both phases.

Results

The 41 statements generated were organised into five cluster concepts: media and messaging, information and education, promotion, legal and accessibility. Accessibility was the highest-rated cluster for effectiveness followed by information and education. Exploratory trends across participant demographics were also identified. Differences in perceived effectiveness of the cluster concepts were observed by gender, race, political affiliation and vaccination status.

Conclusion

This study provides valuable preliminary insights into strategies and factors perceived influential in enhancing HPV vaccination from the perspective of unvaccinated young adults. Using concept mapping, multiple factors were identified that varied in their degree of perceived effectiveness across different groups. Future HPV vaccination interventions should consider multi-component elements to ensure their success and reduce the burden of HPV-related disease.

Systemic inflammation and malaria co-infection in irritable bowel syndrome: a cross-sectional study of 142 Yemeni patients

Por: Ali · N. T. · Mehdi · M. A. H. · Abdullah · R. S. · Gubran · A. N. M. · Al-Abd · N. M. · Ali · G. S. · Mohsen Ali · H.
Objective

To determine the prevalence of malaria co-infection among patients with irritable bowel syndrome (IBS) in Yemen and to evaluate the association of systemic inflammatory biomarkers (neutrophil-to-lymphocyte ratio (NLR), mean platelet volume (MPV) and platelet-to-lymphocyte ratio (PLR)) with this co-infection.

Design

Multicentre, cross-sectional observational study conducted between April and December 2024.

Setting

Primary and secondary healthcare facilities across 21 governorates in Yemen.

Participants

142 consecutive adult patients (aged 18–70 years) diagnosed with IBS according to the Rome IV criteria.

Outcome measures

The primary outcome was the prevalence of malaria infection, confirmed by a rapid diagnostic test . Secondary outcomes included differences in NLR, MPV and PLR between groups, assessed using independent t-tests, and the diagnostic performance of these biomarkers evaluated by receiver operating characteristic curve analysis with AUC calculation. Multivariate binary logistic regression was used to identify independent predictors of malaria co-infection, adjusting for potential confounders.

Results

The mean age was 42.3 years (SD 11.7) with an equal gender distribution. The prevalence of malaria co-infection was 45.1% (64/142). Patients with malaria positivity had significantly higher NLR (mean difference 0.56, 95% CI 0.40 to 0.72; p

Conclusions

Nearly half of the Yemeni patients with IBS in this study had malaria co-infection, with the highest burden in diarrhoea-predominant and mixed subtypes. Elevated NLR and PLR were strongly associated with co-infection, suggesting these readily available biomarkers could aid targeted screening in resource-limited, endemic settings.

Retention in trials: a qualitative evidence synthesis of studies reporting participant reasons for trial non-completion

Por: Murphy · E. · Gillies · K. · Skea · Z. · Biesty · L. · Hunter · A. · Noor · N. M. · McCann · S.
Objectives

Poor participant retention in randomised clinical trials, resulting in missing outcome data, can impact the validity, reliability and generalisability of results. While participants’ views on general non-retention issues have been reported elsewhere, a qualitative evidence synthesis specifically focusing on trial processes (ie, outcome data collection) impacting retention has not been undertaken to date. This is an important research question to inform targeted interventions to support retention. This review aims to address this by systematically searching and synthesising the evidence on participant reasons for trial non-completion, linked to outcome data collection.

Design

We conducted a qualitative evidence synthesis of qualitative studies and mixed methods studies with a qualitative component, in Embase, Ovid MEDLINE, PsycINFO, Cochrane Central Register of Controlled Trials (CENTRAL), Social Science Citation Index, Cumulative Index of Nursing & Allied Health Literature and Applied Social Sciences Index and Abstracts, up to February 2025. We used Thomas and Harden’s thematic synthesis approach. The Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative framework was used to assess confidence in the review findings.

Participants

We identified 11 studies reporting qualitative data from 14 separate trials, with findings from 105 trial non-retainers. The studies were undertaken between 2007 and 2025.

Results

There were three types of participant non-retention behaviours reported across the studies, where participants either: (1) missed at least one clinic visit; (2) did not complete a postal questionnaire or (3) did not complete online data collection. We developed four analytical themes outlining participant-reported influences on trial non-retention, specifically related to trial processes (ie, data collection for outcome measures): fluctuating health, balancing trial burdens, navigating life as a trial participant and managing expectations of participation.

Conclusions

This review generates important insights into participants’ reasons for trial non-completion linked to outcome data collection. The review highlights the need for further research into supporting trial recruitment discussions that provide clear, realistic expectations for potential trial participants, as well as strategies that recognise, and where possible, address some of the influences on participants to improve outcome data completeness and ultimately improve trial retention.

Determinants of male global health and quality of life in Switzerland: a cross-sectional study using a gender-diverse approach

Por: Lieb · M. · Laskowski · N. M. · Müller · R. · Paslakis · G.
Background

Men, particularly those belonging to gender minority groups, often experience poorer physical health outcomes. This study examined global health and quality of life (QoL) across diverse male gender subgroups in Switzerland. While emphasising male gender diversity, we aimed to identify key sociodemographic risk factors associated with reduced global health and QoL.

Methods

We analysed a subset of the Swiss Health Survey 2022, a cross-sectional nationally representative health-related dataset from the general Swiss population. Our sample included individuals falling into one of the three groups: cisgender men, transgender men (assigned female at birth with male gender identity) and men with ‘other’ gender identities (assigned male at birth but identifying as non-binary or non-specified gender identity). Global health and QoL were assessed using the Minimum European Health Module (MEHM) and the global QoL item of the WHOQOL-Bref. Four binary logistic regression models examined the association between male gender identities, sociodemographic data and MEHM and QoL outcomes.

Results

Our study comprised 3 505 801 male cases after weighting. Of these, 12.9% reported fair to very poor health. Key risk factors included being unemployed, migration background and being a transgender man. The strongest protective factor was higher education. Chronic conditions were reported by 33.3% men, with unemployment again being the most relevant risk factor. Identifying as a man with ‘other’ gender identities emerged as a protective factor. Regarding QoL, 8% stated impaired QoL, while the male gender identity ‘other’ was the strongest risk factor and tertiary school education the most relevant protective factor.

Discussion

Risk and protective factors vary across different global health outcomes and QoL in men. These findings highlight the importance of disaggregating male gender categories beyond the binary to better understand the complexity of health disparities. A differentiated, gender-inclusive approach is essential for accurately identifying vulnerable groups and tailoring public health interventions accordingly.

Risk factors for COVID-19 symptom severity across clinical categories among hospitalised patients in Kuala Lumpur, Malaysia: a prospective cohort study

Por: Johdi · N. A. · Abdullah · N. · Goh · Y.-X. · Min · J. O. S. · Muhammad Azami · N. A. · Abdul Jalal · M. I. · Mohammed Nawi · A. · Ahmad · N. · Hassan · M. R. · Sulong · A. · Kori · N. · Periyasamy · P. · Hamid · F. · Sapuan · N. M. · Selvam · S. B. P. · Hajib · N. · Mustafa · N. · Rashi
Objectives

This study aimed to quantify how patient risk factors relate to COVID-19 severity across categories 1–5 in a prospective, hospital-based cohort. We hypothesised that greater severity would be associated with higher odds of intensive care unit (ICU) admission and in-hospital mortality. Secondary aims were to assess associations with age, viral variants, symptom clusters, lymphocyte count, fasting blood glucose and cytokine profiles.

Design

Prospective cohort study.

Setting

A secondary-care/tertiary-care hospital and linked community settings in Cheras, Kuala Lumpur, Malaysia.

Participants

This study was nested within the COVGEN project, a prospective COVID-19 cohort conducted at Hospital Canselor Tuanku Muhriz UKM (HCTM), Cheras Health Clinic and the Bandar Tun Razak COVID-19 Assessment Centre in Cheras, Kuala Lumpur, Malaysia, from 1 August 2021 to 31 October 2022. 2532 participants were enrolled at baseline. Eligible participants were Malaysian citizens aged 12–18 years (paediatric/adolescent) or ≥18 years who had reverse transcription-polymerase chain reaction–confirmed COVID-19 at recruitment and resided in Kuala Lumpur or Selangor. Patients who had a clinically unstable condition and those who declined participation (personally or via a next-of-kin or legal representative) were excluded. This analysis included 559 patients hospitalised at HCTM; after excluding five with incomplete questionnaires, 554 remained for analysis (413 admitted to general wards and 141 to ICUs). Categories 3–5 comprised hospitalised patients, whereas categories 1–2 included hospitalised individuals and a subset recruited from community settings.

Primary and secondary outcome measures

Primary outcomes included disease severity (categories 4–5 vs 1–3), ICU admission and in-hospital mortality. Secondary outcomes included associations with age strata, viral variant (delta vs omicron), symptom clusters, lymphocyte count, fasting blood glucose and cytokines: interferon gamma-inducible protein 10, interferon gamma, interleukins 8, 10, 2, 6 and 7 and tumour necrosis factor alpha.

Results

141 of 554 (25.5%) patients required ICU care. Compared with milder categories, category 5 was associated with markedly higher odds of ICU admission (OR 204.50; 95% CI 37.54 to 1114.18; p55 versus

Conclusions

An increasing clinical severity category was strongly associated with ICU admission and mortality. Age, delta infection, specific symptom clusters, lymphopenia, hyperglycaemia and pro-inflammatory cytokines identified higher-risk patients, supporting risk-stratified management and prioritisation for enhanced monitoring.

Dietary practices among antenatal women in Sri Lanka: prevalence and associated factors

Objective

To assess the prevalence and associated factors of dietary practices among antenatal women in Colombo district, Sri Lanka.

Design

This descriptive cross-sectional study examined dietary practices among antenatal mothers in four Medical Officer of Health areas in Colombo, Sri Lanka. A total of 422 participants were selected using stratified random sampling. Data were collected via a validated Food Frequency Questionnaire and analysed using SPSS V.26. Dietary diversity, food variety and animal-source food consumption were assessed. Poisson regression identified predictors of dietary practices, adjusting for socio-economic and pregnancy-related factors. The statistical significance was set at p

Results

Of the 380 antenatal mothers (mean age: 30.72±3.96 years), most were married (98.2%) with 73.7% living in urban areas. Regarding dietary practices, 64.7% had high dietary diversity, while 35.3% had low diversity. Of the sample, 52.1% had a high food variety score and 64.7% had a high animal-source food score. More than half (64.7%) had appropriate dietary practices. Fruits, vitamin A-rich vegetables and rice were the most consumed foods. Key factors influencing dietary practices included age, religion, education, employment and geographical location.

Conclusions

This study highlights the prevalence and factors influencing dietary practices among antenatal mothers. Although the predominant mothers had fair dietary diversities, a considerable number were found to have poor dietary practices. Better dietary practices were associated with major educational attainment, formal employment status and selected residential areas, while younger age, low educational qualification and housewife status were associated with poorer nutrition. The findings indicate that there is an urgent need for interventions related to nutrition for specific vulnerable groups so that they can improve their maternal nutrition and produce better pregnancy outcomes through education and support programmes.

Building a functional resonance analysis method (FRAM) in healthcare: a systematic review on how steps are reported, defined and supported by data

Por: Luijcks · N. M. · Bazuin · T. · Adriaensen · A. · Visser · A. · Dongelmans · D. · Groeneweg · J. · van der Laan · M. J. · Marang-van de Mheen · P.
Objectives

The functional resonance analysis method (FRAM) is increasingly used to analyse healthcare processes. FRAM uses four steps to analyse a process and its potential variability. We systematically reviewed studies using FRAM in healthcare on how the four steps in FRAM are reported, defined and supported by data.

Design

Systematic review following the preferred reporting items for systematic reviews and meta-analyses 2020 guidelines.

Data sources

Web of Science, PubMed, Embase, Scopus, PsycINFO, Dimensions and Lens were searched up to December 2025.

Eligibility criteria for selecting studies

All peer-reviewed studies using FRAM in a healthcare context that presented a FRAM visualisation were included. The papers had to be written in English.

Data extraction and synthesis

Two independent reviewers screened titles and abstracts, and subsequently the full text of selected papers. Data was extracted reporting on the steps of FRAM, how functions were supported by data, and the functions and couplings of the visualisations.

Results

Sixty-eight papers were included, of which 20 (29%) reported at least one aspect of all four steps in FRAM. While most studies (85%) described how functions were supported by data, the methods used varied widely. Terminology was interpreted differently concerning variability, the output of variability and the effect of combined variability.

Conclusion

Most FRAM studies in healthcare do not report all steps of FRAM, and interpretations of key terms differ. FRAM studies should more clearly describe which steps of the method are conducted, and how data is collected and analysed. Refinement of FRAM guidelines, particularly on data use and terminology, would enhance consistency and comparability across studies.

PROSPERO registration number

CRD42024592858.

Decisional needs among patients and physicians in the treatment of chronic myeloid leukaemia: a qualitative analysis in the Netherlands

Por: Mingels · S. · Cloots · M. J. J. · Smit · Y. · Blijlevens · N. M. A. · Posthuma · E. F. M. · Dekker · A. L. A. J. · Fijten · R. R. R. · Wener · E. · Kromkamp · C. C. G.
Objective

Treatment advancements in chronic myeloid leukaemia (CML) have made the disease manageable but carry significant risk of side effects. Bridging information gaps between patients and physicians through shared decision-making (SDM) is increasingly favoured, yet understanding treatment complexities remains a challenge. This study sought to identify decisional and informational needs of both patients and physicians in CML care.

Design

A qualitative study using semi-structured interviews was conducted to investigate the opinions, attitudes and preferences of both patients with chronic myeloid leukaemia and physicians.

Setting

Patients and physicians were recruited through the Dutch CMyLife platform, an initiative of haematologists, patients and patient organisations. They were provided with the participant information and invited to participate if interested.

Participants

A total of 15 interviews (n=10 patients, n=5 physicians) were conducted between April and October 2023.

Primary and secondary outcome measures

A pre-defined interview guide was developed based on the Decisional Needs Assessment questionnaire. Interview transcripts were thematically analysed.

Results

Eight themes and 28 sub-themes were observed, highlighting patient needs, treatment choices and informational preferences. Patients emphasised the importance of understanding medication options and side effects, while physicians stressed the necessity of delivering up-to-date and comprehensible information. Almost all participants had experienced professionals making the treatment decision, without patient involvement, especially when initiating treatment. Some patients expressed too little information and missed partnership with professionals at treatment onset. Peer support, decision-making dynamics and the role of caregivers were also significant considerations.

Conclusions

Both shared and distinct perspectives on CML treatment decision-making between patients and physicians were revealed, underscoring the complexity of decisional needs in CML management. The findings emphasise the importance of patient-centred care, SDM and tailored communication strategies to optimise patient outcomes and satisfaction. Improved communication and evidence-based decision-making tools can significantly impact patient well-being. Further research and interventions are necessary to address the challenges in decision-making processes in CML care.

Weight-loss effects of macronutrient-based diets modified by genetic variants: a protocol for systematic review of randomised controlled trials

Por: Subardjo · Y. P. · Khairunnissa · N. M. · Kusuma · R. J. · Huriyati · E. · Susetyowati · S.
Introduction

Personalised nutrition that incorporates genetic results into dietary interventions holds significant potential to optimise weight management and metabolic outcomes. While traditional calorie-restricted diets remain effective, emerging evidence suggests that variations in macronutrient distribution may offer additional benefits. Genetic variants help explain interindividual differences in dietary responses, with certain alleles showing enhanced weight loss and metabolic improvements with specific macronutrient distributions. However, comprehensive reviews of randomised controlled trials (RCTs) examining genotype-based dietary effects, particularly those focusing on macronutrient distribution metabolic pathway interactions, are lacking, limiting the development of robust evidence-based guidelines for nutrigenetic counselling. This systematic review aims to assess the influence of genetic variants on weight loss outcome in adults in response to varying macronutrient distribution diets (eg, low-fat, low-carbohydrate, high-protein diets) using evidence from RCTs.

Methods and analysis

We will systematically review RCTs examining weight loss outcomes of macronutrient-varied diets in adults with genotype stratifications to risk and protective allele. Multiple databases, PubMed, Cochrane Library, Scopus, Science Direct and Google Scholar, will be used. Reviewers will screen studies, extract data on study characteristics, weight loss, metabolic marker outcomes and genetic data, and assess the risk of bias using the Cochrane Risk of Bias Tool 2.0 tool.

All eligible RCTs will first be summarised in structured tables describing study characteristics, macronutrient distribution and genetic variants and will be analysed with narrative synthesis. For quantitative analysis, interventions will be grouped into three predefined diet types (high-protein, low to moderate carbohydrate and low-fat diet). Because heterogeneity across diet categories is expected, pooled effects will be estimated separately within each diet subgroup using random-effects meta-analysis, expressed as mean differences in weight change (kg). Within each subgroup, and when at least 10 studies or data are available, random-effects meta-regression will be used to examine potential moderators, including intervention duration, physical activity and ancestry. Heterogeneity will be evaluated using I2 and 2, and publication bias assessed when feasible. Evidence certainty will be graded using Grading of Recommendations Assessment, Development and Evaluation.

Ethics and dissemination

Ethical approval is not required for this protocol as it involves the analysis of data from primary studies. The findings will be disseminated through publication in peer-reviewed journals. Any enquiries regarding research integrity of this protocol may be directed to the Head of the Doctoral Program in Medical Health and Sciences, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada via the institutional email address s3fk@ugm.ac.id, as the responsible academic authority for research integrity.

PROSPERO registration number

CRD420251050587.

Functional Assessment for Surgery by a Timed Walk (FAST Walk) study: protocol for a multicentre prospective cohort study of the 6 min walk test for preoperative risk stratification in major non-cardiac surgery

Por: Wijeysundera · D. N. · Salbach · N. M. · Chan · M. T. V. · Alibhai · S. M. H. · Puts · M. T. E. · Jerath · A. · Khadaroo · R. · Ehtesham · S. · Pazmino-Canizares · J. · Ladha · K. S. · Granton · J. T. · Amado · L. · Duceppe · E. · Hladkowicz · E. · Lee · S. M. · Macdonell · S.-Y. · Par
Introduction

Poor cardiopulmonary fitness is an important risk factor for postoperative complications, yet a feasible, objective and prognostically accurate method to assess preoperative fitness has not been established. The 6 min walk test (6MWT) is a simple, inexpensive and widely applicable measure that shows promise for predicting postoperative risk. However, robust data are lacking on whether the 6MWT accurately predicts complications, provides incremental prognostic value beyond routinely collected clinical factors or outperforms simpler alternatives such as questionnaires, cardiac biomarkers or grip strength testing. The Functional Assessment for Surgery by a Timed Walk (FAST Walk) study is designed to address these knowledge gaps by evaluating whether the 6MWT improves prediction of key postoperative outcomes compared with clinical factors and simpler measures of fitness.

Methods and analysis

The FAST Walk study is an international multicentre prospective cohort study of 1672 adults (≥40 years) undergoing major elective non-cardiac surgery at centres in Canada, Hong Kong, Australia, Spain and the Netherlands. Participants complete a preoperative 6MWT and baseline assessments of comorbidities, self-reported cardiopulmonary fitness (MET: Re-evaluation for Perioperative Cardiac Risk questionnaire), biomarkers (N-terminal pro-B-type natriuretic peptide) and grip strength. The primary outcome is 30-day death or major postoperative complication, defined as Clavien-Dindo grade II or higher. Secondary outcomes are (1) death or new significant disability at 90 days after surgery and (2) days alive and out of hospital at 30 days after surgery. Disability is measured using the short-form WHO Disability Assessment Schedule 2.0 instrument. Multivariable regression models and complementary metrics of prediction performance will be used to determine whether 6MWT distance adds prognostic value beyond routinely collected clinical factors and simpler measures of fitness.

Ethics and dissemination

The FAST Walk study has received research ethics board approval at all participating sites. Recruitment commenced in June 2024, with completion of participant follow-up expected in 2026. Findings will be disseminated through peer-reviewed publications and conference presentations, with the primary results anticipated in 2027.

Trial registration number

NCT06412367.

Weaning patients off long-term prednisolone: a survey of physicians practice in the UK and Southeast Asia

Por: Lazarus · K. · Eng · P. C. · Narula · K. · Sharma · A. · Choudhury · S. · Papadopoulou · D. · Martin · N. M. · Wernig · F. · Tan · T. · Meeran · K.
Study objective

Prolonged glucocorticoid (GC) use is associated with significant morbidity and mortality, including the development of GC induced adrenal insufficiency. Recent guidance from the European Society of Endocrinology and Endocrine Society provides a framework for tapering GCs. However, there is limited understanding of current practice across endocrine and other medical specialties, including barriers and challenges to GC weaning. This study aimed to establish how GCs are weaned in patients across endocrine and non-endocrine specialists.

Design and setting

Anonymous online surveys were disseminated to all members of the Society for Endocrinology and all members of the Association of Southeast Asian Nations Federation of Endocrine Societies and the Endocrine and Metabolic Society of Singapore. Non-endocrine specialists were surveyed in the UK and in Singapore.

Results

A total of 306 (258 endocrine specialists and 48 non-endocrine specialists) responded to the survey. Approaches to discontinuing prednisolone were heterogeneous. Among endocrine respondents, only 78% would fully wean the prednisolone, with 50.4% switching to hydrocortisone to wean and 12.6% favouring long-term GC replacement without further investigations. Among the non-endocrine respondents, 16.7% would stop prednisolone abruptly and 10.4% would refer to endocrinology to supervise weaning. The most common barrier to weaning GCs reported by both endocrine and non-endocrine specialists was relapse of the underlying condition (55.9% and 70.8%, respectively).

Conclusions

Relapse of the underlying condition is common, and endocrinology input may not be appropriate when this occurs. There remains a need to develop an evidence-based approach for safe and effective GC weaning and hypothalamic–pituitary–adrenal axis assessment.

How do musculoskeletal disorders impact on quality of life in Tanzania? Results from a community-based survey

Por: Grieve · E. · Deidda · M. · Krauth · S. J. · Biswaro · S. M. · Halliday · J. E. B. · Hsieh · P.-H. · Kelly · C. · Kilonzo · K. · Kiula · K. P. · Kolimba · R. · Msoka · E. F. · Siebert · S. · Walker · R. · Yongolo · N. M. · Mmbaga · B. · McIntosh · E. · NIHR Global Health Group · Biswaro
Objectives

There are little available data on the prevalence, economic and quality of life impacts of musculoskeletal disorders in sub-Saharan Africa. This lack of evidence is wholly disproportionate to the significant disability burden of musculoskeletal disorders as reported in high-income countries. Our research aimed to undertake an adequately powered study to identify, measure and value the health impact of musculoskeletal conditions in the Kilimanjaro region, Tanzania.

Design

A community-based cross-sectional survey was undertaken between January 2021 and September 2021. A two-stage cluster sampling with replacement and probability proportional to size was used to select a representative sample of the population.

Setting

The survey was conducted in 15 villages in the Hai District, Kilimanjaro region, Tanzania.

Participants

Economic and health-related quality of life (HRQOL) questionnaires were administered to a sample of residents (aged over 5 years old) in selected households (N=1050). There were a total of 594 respondents, of whom 153 had a confirmed musculoskeletal disorder and 441 matched controls. Almost three-quarters of those identified as having a musculoskeletal disorder were female and had an average age of 66 years.

Primary and secondary outcome measures

Questions on healthcare resource use, expenditure and quality of life were administered to all participants, with additional more detailed economic and quality of life questions administered to those who screened positive, indicating probable arthritis.

Results

There is a statistically significant reduction in HRQOL, on average 25% from a utility score of 0.862 (0.837, 0.886) to 0.636 (0.580, 0.692) for those identified as having a musculoskeletal disorder compared with those without. The attributes ‘pain’ and ‘discomfort’ were the major contributors to this reduction in HRQOL.

Conclusions

This research has revealed a significant impact of musculoskeletal conditions on HRQOL in the Hai district in Tanzania. The evidence will be used to guide clinical health practices, interventions design, service provisions and health promotion and awareness activities at institutional, regional and national levels.

Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study

Por: Murea · M. · Foley · K. L. · Gautam · S. C. · Flythe · J. E. · Raimann · J. G. · Abdel-Rahman · E. · Awad · A. S. · Niyyar · V. D. · Kovach · C. · Roberts · G. V. · Jefferson · N. M. · Conway · P. T. · Rosales · L. M. · Woldemichael · J. · Sheikh · H. I. · Raman · G. · Huml · A. M. · Kni
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT05828823.

Preventing kidney injury using carbon dioxide (KID trial): trial protocol for a multicentre randomised controlled trial

Por: Saratzis · A. · Rasheed · N. · Aguirre · D. · Coughlin · P. · Diamantopoulos · A. · Bearne · L. · Selby · N. M. · Brookes · C. · Barber · S. · Richardson · C. · Gilbert · H. · Schueller · R. · Apergi · D. · Harris · K. J.
Introduction

Peripheral arterial disease (PAD) commonly coexists with chronic kidney disease (CKD). Patients with symptomatic PAD often require endovascular revascularisation to relieve pain or salvage limbs. However, the iodinated intra-arterial contrast routinely used in these procedures is nephrotoxic, placing patients with CKD at increased risk of acute kidney injury (AKI) and long-term renal decline. Carbon dioxide (CO2) delivered via automated injection is a potential alternative imaging contrast medium. This trial will evaluate whether using CO2 instead of iodinated contrast reduces the risk of AKI and short-term renal function decline in this high-risk group.

Methods and analysis

This is a multicentre, open-label, prospective randomised controlled trial across six secondary-care National Health Service (NHS) vascular surgery centres. A total of 174 patients with PAD and CKD undergoing endovascular intervention will be randomised 1:1 to receive iodinated contrast (standard of care) or CO2 via automated injector (Angiodroid). All perioperative care will follow local NHS protocols.

The primary outcome is log serum creatinine at 2, 30 and 90 days postprocedure. Key secondary outcomes include: incidence and severity of AKI within 48 hours postprocedure, major adverse kidney events (death, dialysis or >25% estimated glomerular filtration rate decline) by 90 days, inpatient length of stay, procedural pain, quality of life, procedural success, reinterventions, acceptability and feasibility (patient/practitioner questionnaires) of using CO2, and cost-effectiveness (healthcare resource use analysis). A mixed-methods process evaluation will be undertaken with patients and clinicians.

Ethics and dissemination

The trial has been approved by an NHS ethical review committee (24/WA/0332) and patients have been involved in trial design. Findings will be disseminated to participants, clinicians and the wider public through patient groups, lay summaries, social media, conferences, peer-reviewed journals and NHS policy channels.

Trial registration number

ISRCTN23564393.

Effectiveness of steroid injection on functional outcomes in adults with trigger finger: a systematic review and meta-analysis protocol

Por: Navaneeth · P. · Geevarughese · N. M. · Bhat · A. K.
Introduction

Corticosteroid injections are widely used as first-line treatment for trigger finger, but their comparative efficacy against other non-surgical and surgical interventions remains unclear. While previous meta-analyses have explored this topic, many were limited by a narrow scope or methodological constraints. This systematic review and meta-analysis aims to comprehensively evaluate the effectiveness and safety of corticosteroid injections in adult trigger finger management compared with alternative treatment modalities, using robust methodology and updated evidence to guide clinical decision-making.

Methods and analysis

A systematic search will be conducted to identify the articles published on PubMed, Embase, Scopus and the Cochrane Library. All randomised controlled trials that compared (1) corticosteroid injection with alternative non-surgical modalities and (2) corticosteroid injection with surgical intervention in adults diagnosed with trigger finger will be included for the review. Two reviewers will independently perform the processes of study inclusion, data extraction and quality assessment. The primary outcome will be assessed by improvement in triggering and pain symptoms. Secondary outcomes will be assessed through safety assessment. The risk of bias and meta-analysis will be conducted using by RevMan V.5.4.

Ethics and dissemination

Ethical approval is not required for this study as it is a review based on published studies. The results will be disseminated through peer-reviewed publications and conference presentations. The findings of this systematic review and meta-analysis results are expected to provide valuable information for clinicians to choose an optimal strategy for the management of trigger finger.

PROSPERO registration number

CRD42024547312.

Validation of the Clinical Frailty Scale for predicting 90-day mortality in hospitalised older adults screened as at risk of nearing the end of life in Queensland, Australia: a multisite observational study

Por: Blythe · R. · White · N. M. · Brown · C. · Hillman · K. · Barnett · A. G.
Background

The Clinical Frailty Scale is an ordinal scale from 1 (very fit) to 9 (terminally ill) commonly used to assess frailty in older patients. It is simple for clinicians to apply and can help identify patients who may benefit from discussions around end-of-life care. We externally validated the Scale to assess its performance for predicting 90-day mortality in a cohort of admitted older patients who had screened positive for being at risk of nearing the end of life.

Methods

We used data from a randomised controlled trial assessing a tailored feedback loop for reducing non-beneficial care. Our study included patients aged 75 and above admitted between May 2020 and June 2021 from 3 Australian hospitals. We assessed whether the Scale could be used in a frail population to identify patients who were at risk of short-term mortality. Predictive performance was assessed using the c-statistic, smoothed calibration curves and decision curves. Models were tested for coefficient stability.

Results

Our dataset contained 4639 patients and 956 deaths within 90 days. The Clinical Frailty Scale had a c-statistic of 0.62 (95% CI 0.60 to 0.64) or 0.63 (95% CI 0.61 to 0.65) by adding age and transforming the Scale using a cubic spline. Risks were underestimated without a non-linear transformation as scores of 8 and 9 had a higher risk that diverged from a linear association. The net benefit of using the tool was greatest between 5 and 8 on the Scale.

Conclusions

The utility of the Clinical Frailty Scale may be as a flag to encourage clinicians to become more comfortable with discussing ageing and death, rather than as a highly discriminating model to classify patients as high risk or low risk. Statistical uncertainty over mortality should not be a barrier to initiating end-of-life care discussions with frail older patients.

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