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Vocal biomarkers for geriatric health assessment: a scoping review protocol

Por: Amir-Behghadami · M. · Gholipour · K. · Mohammadzadeh · Z.
Introduction

Global ageing populations require accessible, non-invasive tools for early detection and monitoring of neurological chronic and neurodegenerative diseases. Current diagnostic methods face limitations including invasiveness, high costs and infrequent clinical assessments. The human voice has emerged as a promising digital biomarker, with vocal characteristics reflecting physiological and cognitive changes associated with conditions like dementia and Parkinson’s disease. While artificial intelligence (AI) and machine learning have enabled sophisticated vocal analysis, the literature remains fragmented without comprehensive synthesis. This scoping review protocol delineates a systematic approach to collate and synthesise existing research on the application of AI-driven audio biomarkers for the detection and management of neurological diseases (eg, cognitive decline, Parkinson’s disease, Alzheimer’s, dementia and depression) in older adults aged 65 years and above.

Methods and analysis

This scoping review will be conducted in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines and the methodological framework proposed by Arksey and O’Malley, incorporating recent methodological advancements. The eligibility criteria for study selection will be formulated using the PCC (Population, Concept, Context) framework. A comprehensive literature search will be performed across several electronic databases, including PubMed/MEDLINE, Scopus, Web of Science, IEEE Xplore, Embase, Compendex, CINAHL, Scientific Information Database (SID), Magiran, IranMedex and Barakat Knowledge Network System (BKNS). The search will encompass peer-reviewed articles published in Persian and English from 1 January 2012 to 31 March 2026. Two independent reviewers will screen titles, abstracts and full texts and extract data according to the predefined PCC-based eligibility criteria. Discrepancies will be resolved through discussion or, if necessary, by consultation with a third reviewer. The results will be synthesised and presented narratively, accompanied by summary tables, charts and figures to address each research question.

Ethics and dissemination

The Research Ethics Committee of Tabriz University of Medical Sciences approved the protocol for this scoping review (approval number: IR.TBZMED.VCR.REC.1404.223). They concluded that since the review involves only analysis of existing literature without direct patient involvement or clinical procedures, it meets the relevant ethical standards. Results from the review will be shared through peer-reviewed journals and conference presentations to provide valuable insights for researchers, clinicians and policymakers on the use of audio-based biomarkers in older adults.

PROSPERO registration number

Not registered.

Longitudinal study of childbirth readiness and its related factors and consequences among low-risk pregnant women attending health centres in Tabriz, Iran

Objective

Childbirth readiness can reflect women’s childbirth readiness in terms of knowledge, psychological aspects and planning. The purpose of this study was to evaluate childbirth readiness, its related factors and consequences in Iranian pregnant women.

Design

This longitudinal study was the first stage (quantitative stage) of a sequential explanatory mixed-method study. It followed women during late pregnancy (from 37 weeks of gestation) and the postpartum period (4–6 weeks after childbirth) from March to September 2023.

Setting

Health centres of Tabriz, Iran.

Participants

This study involved 360 pregnant women with a gestational age of 37 weeks and above, selected via cluster sampling. Participants were excluded for high-risk pregnancies, unfavourable incidents in the last 3 months, mental-psychological diseases or a prior caesarean section.

Outcome measures

Childbirth readiness and its related factors were assessed using several instruments completed from the 37th week of pregnancy onward, including the Childbirth Readiness Scale, a sociodemographic questionnaire, the Pregnancy Experience Scale and the Wijma Delivery Expectancy/Experience Questionnaire Version A. The consequences of childbirth readiness were then evaluated 4–6 weeks post partum using the Childbirth Experience Questionnaire, the Edinburgh Postnatal Depression Scale and the Postpartum-Specific Anxiety Scale.

Results

The mean (SD) childbirth readiness score was 67.83 (9.41) out of 90. In the adjusted general linear model (GLM), several factors were significantly associated with lower readiness. These included a higher fear of childbirth score (β –0.12, 95% CI –0.16 to –0.08, p

Conclusions

Key factors associated with readiness included fear of childbirth, obstetric history (gravidity, parity, history of abortion and participation in childbirth readiness classes), maternal education, home ownership, husband’s occupation—though several associations showed small effect sizes. After adjustment, readiness did not independently predict childbirth experience or postpartum mental health. The low participation rate in readiness courses highlights a major service gap. Integrating readiness assessment into prenatal care and expanding access to targeted education are recommended to improve outcomes such as birth satisfaction and caesarean rates.

Associations between food-related behaviours, nutrient intake and nutritional status through Structural Equation Model (SEM) among clients undergoing Community-Based Treatment and Rehabilitation (CBTaR): A cross-sectional study in Kelantan, Malaysia

Por: Aji · A. S. · Rohana · A. J. · Geik · O. P. · Rafdinal · W. · Wan Mohammad · W. M. Z. · Mohd Yasin · M. A. · Tengku Ismail · T. A. · Vanoh · D. · Mohamed · N. N.
Objective

To examine the associations between food-related behaviours and nutrient intake on nutritional status among clients undergoing Community-Based Treatment and Rehabilitation (CBTaR) in Kelantan, Malaysia.

Design

Cross-sectional analytical study.

Setting

Seven CBTaR centres (n=7) across the state of Kelantan, Malaysia.

Participants

A total of 393 adult clients (aged 18 years and above) enrolled in CBTaR programmes between June and December 2022 were selected through stratified random sampling.

Primary and secondary outcome measures

The primary outcome was nutritional status, assessed using body mass index. Secondary outcomes included nutrient intake (macronutrients and micronutrients) and food-related behaviours (emotional eating, external eating, restrained eating and food addiction), measured through Bahasa Malaysia validated questionnaires and 24-hour dietary recalls. All variables were introduced into the structural equation modelling to examine the associations among these variables and their association with nutritional status.

Results

The results revealed that food-related behaviour was significantly associated with the nutrient intake (β=–0.524, p≤0.001). Additionally, the drug use profile significantly determined the food-related behaviour (β=–0.129, p=0.006) and nutritional status (β=–0.134, p=0.007). Nutrient intake was found to be a significant predictor of nutritional status (β=–0.213, p≤0.001). Sociodemographic and drug use profiles were significantly correlated with nutritional outcomes through behavioural and dietary associations. Importance-performance map analysis identified nutrient intake as the most impactful variable, highlighting the need for urgent intervention (R2=0.272).

Conclusions

This study highlights that nutrient intake is a significant predictor associated with food-related behaviours on nutritional status among individuals with substance use disorder. Integrating nutrition counselling and behavioural interventions into CBTaR services may improve recovery and long-term health outcomes.

Effects of multimodal nutritional intervention on nutritional status and clinical outcomes in patients with systemic sclerosis: study protocol for a randomised controlled trial

Por: Shahmohammadi · F. · Kavosi · H. · Naeini · F. · Imani · H. · Mohammadi · H.
Introduction

Systemic sclerosis (SSc) is an autoimmune disorder causing progressive fibrosis of internal organs and skin, leading to increased thickness and rigidity. It frequently results in malnutrition, which can decrease survival rates and physical performance, while also imposing financial burdens on healthcare systems and society. Multimodal nutritional interventions may encompass various approaches, including nutritional counselling, consumption of oral nutritional supplements and disease-specific dietary regimens based on nutritional needs. The present clinical trial is designed to examine the effectiveness of multimodal nutritional intervention on nutritional status, quality of life, food intake, body composition and fatigue in patients with SSc.

Methods and analysis

This is a parallel, randomised, placebo-controlled clinical trial that will investigate the impacts of multimodal nutritional interventions in SSc patients. 46 qualified SSc participants will be chosen at random and given multimodal nutritional intervention or dietary recommendations for a period of 8 weeks. The primary outcomes of this study are changes in nutritional status and quality of life. The secondary outcomes include changes in body composition, fatigue, body weight, body mass index and calf circumference. Statistical analysis will be conducted using the SPSS software (Version 24).

Ethics and dissemination

The current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICINE.REC.1403.345). The findings will be submitted to international, peer-reviewed publications and presented at national and international conferences.

Trial registration number

IRCT20220208053971N4.

Patterns and characteristics of cranial nerve neuropathy in West Nile virus infection: a systematic review of cases reported globally

Por: Abu-Hammad · A. · Alshamasneh · L. · Abu-Hammad · O. · Albdour · B. · Maraqa · I. · Alkhader · M. · Al-Fatafta · D. · Dar-Odeh · N.
Objective

This study aims to review case reports/series on West Nile virus (WNV) infection-associated cranial nerve (CN) neuropathy to explore the associated patterns and characteristics.

Design

A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria.

Data sources

We reviewed the literature in PubMed/Medline, Google Scholar and ScienceDirect databases to retrieve relevant case reports.

Eligibility criteria

Case reports published in the past 25 years on CN neuropathy in WNV-infected patients, with no language or geographic restrictions.

Data extraction and synthesis

Retrieved data included patient demographics, disease presentation and treatment outcomes. Descriptive statistical analyses were performed to describe frequency and characteristics of CN neuropathies. Cross tabulation was performed to calculate statistical significance of association between patient characteristics, disease factors and treatment outcomes. Risk of bias was assessed using the JBI Critical Appraisal Tool for case reports.

Results

A total of 30 case reports satisfied inclusion criteria. These studies described 42 cases that developed CN neuropathies as an outcome of WNV infection. Patients were in the main males (54.8%) and had a mean age of 52.5±15.5 years. The most frequently affected CNs were, in descending order, optic (n=21, 50.0%), facial (n=14, 33.3%) and abducent nerves (n=8, 19.0%). Age was significantly associated with optic nerve neuropathy (≥51 years) and facial palsy (

Conclusions

CN neuropathy represents an important subset of neuroinvasive disease caused by WNV. There is a slight male preponderance among the patient population who are mostly middle aged. Optic and facial nerves are mostly affected. Most patients show complete recovery, particularly in the absence of chronic diseases. The role of systemic antivirals in improving disease outcomes should be further investigated. Early detection of CN neuropathies is recommended by routine CN screening and use of specific tools such as MRI and neurophysiological tests.

Adherence to Choosing Wisely Africa recommendations in breast cancer care: a cross-sectional study across three Sub-Saharan African centres

Por: Rubagumya · F. · Rugengamanzi · E. · Nyagabona · S. K. · Ndumbalo · J. · Kwizera · V. · Uwimbabazi · A. · Celyna · K. · Ayettey · H. · Vanderpuye · V. · Hopman · W. M. · Hammad · N. · Booth · C. M.
Objective

The expenses associated with cancer treatment are increasing at a rapid pace. The financial strain of providing care is experienced worldwide, but is particularly pronounced in low and middle-income countries (LMICs). This has resulted in a growing acknowledgement of the importance of value-based cancer care. Choosing Wisely Africa (CWA) is an initiative aimed at reducing the excessive use and expenses associated with cancer treatment. In this study, we assessed adherence to CWA recommendations for the treatment of breast cancer in three high-volume cancer centres in Sub-Saharan Africa (SSA).

Design

A cross-sectional study across Rwanda, Ghana and Tanzania was conducted, involving a review of medical records to assess adherence to five measurable CWA practices in breast cancer care. The study used inferential statistics, such as 2 tests, to compare adherence among these countries.

Settings

This study was conducted in three cancer centres (Ocean Road Cancer Institute, Rwanda Military Hospital and Korle Bu Teaching Hospital) in three countries (Tanzania, Rwanda and Ghana, respectively).

Participants

A total of 542 patients were recruited. Eligible patients were those with a breast cancer diagnosis and complete data as pertaining to five CWA recommendations.

Results

A total of 542 participants with a mean age of 51 years were included. Participants were well distributed across Ghana (37%), Rwanda (34%) and Tanzania (29%). Female patients represented 97% of the study cohort. Half (51%) of the participants had some form of insurance. The study observed high adherence to cancer staging (94%) before treatment and histological confirmation (91%) before breast lump removal across all sites. Hypofractionation was used in 0% of cases in Rwanda, 42% in Ghana and 70% in Tanzania.

Conclusion

This study provides critical insights into the implementation of CWA recommendations in breast cancer care in SSA. It highlights the disparities in adherence to CWA recommendations across different centres, showing the need for policy-driven changes and healthcare infrastructure improvement to standardise cancer care practices in LMICs.

Prognostic machine learning models for predicting postoperative complications following general surgery in Bandar Abbas, Iran: a study protocol

Por: Vatankhah Tarbebar · M. · Mohammadi · M. · Mehrnoush · V. · Darsareh · F.
Introduction

To enhance the quality of surgical care, complications need to be minimised. Consequently, comprehending the occurrence and risk elements for postoperative complications is essential. Subsequently, we will apply machine learning (ML) algorithms to build risk factor prediction models that will assist surgeons in identifying the risk factors associated with the development of postoperative complications after general surgery.

Methods and analysis

This research will take place at a tertiary referral medical centre located in Bandar Abbas, Hormozgan, Iran. The inclusion criteria are (1) individuals aged 18 years or older who have any type of general surgery and (2) hospitalised from September 2025 to September 2026. Individuals with insufficient data will be excluded. The main outcomes of the study are complications within 30 days of surgery. Patients will be divided into two groups based on whether they develop complications or not. The predictors are classified as (1) patient-related factors, (2) surgery-related factors and (3) postoperative factors. We intend to detect postoperative complications following general surgery using four distinct supervised ML techniques: (1) logistic regression, (2) decision trees, (3) random forests and (4) extreme gradient boosting. Accuracy, precision, recall and F1 score will be used to evaluate the performance of ML models.

Ethics and dissemination

With approval from the Hormozgan University of Medical School Research Ethics Board (IR.HUMS.REC.1404.137), we will carry out a forward-looking analysis of the medical records of patients undergoing general surgery. We will obtain informed consent, and all information will be collected and examined anonymously. The findings of this research will be released in appropriate scientific publications.

Prospective cohort study on the characteristics of acute poisoning patients at a tertiary care hospital in Pakistan

Por: Muhammad · S. · Almani · K. F. · Mughal · U.-u.-R. · Khaskheli · M. S. · Sultana · R. · Tabassum · R. · Ahmed · S. · Ahmad · R. · Kumar · N.
Objective

This study aimed to determine the characteristics of acute poisoning patients.

Design

This was a prospective cohort study.

Setting

The study was conducted for 1 year (1 July 2023 to 30 June 2024) at a tertiary care hospital in Sindh, Pakistan.

Participants

From the patients who arrived at the emergency department due to poisoning, 1404 were registered and included in the study.

Outcome measures

The data were collected on demographics (gender, age, residential area, education, employment) and poisoning characteristics, prehospital care, treatment, and services at the hospital, and treatment outcomes (survived and died). A 2 test was used to find the association between independent variables and treatment outcomes. A multivariate logistic regression model was used to determine the predictors of death at a 95% CI.

Results

The majority of patients were male (57.1%) and aged ≤30 years (77.6%). The poisoning was primarily intentional (67.5%), and pesticides (56.1%) were commonly involved in the poisoning. The patients were managed mainly by symptomatic treatment (98.1%) and gastric lavage (65.1%). Multivariate logistic regression indicated that delayed reporting (adjusted OR (AOR)=2.00; 95% CI 1.20 to 3.36; p=0.008) and non-existence of antidote (AOR=1.81; 95% CI 1.08 to 3.03; p=0.025) increased the odds of death while unintentional poisoning (AOR=0.27; 95% CI 0.14 to 0.51; p

Conclusion

The study found that the intentional pesticide poisoning within uneducated, young populations in rural areas was significantly prevalent, and early identification and management of severe cases and extended hospital stays influenced survival.

From bedside to bug side: clinical, haematological and genetic markers of antibiotic-resistant bacterial isolates from children admitted with sepsis in Kaduna State, Nigeria - a protocol for a cross-sectional study

Por: Musa · S. · Aliyu · S. · Abdullahi · N. B. · Khalid · H. L. · Salihu · S. K. · Dahiru · A. U. · Muhammad · A. A. · Abdullahi · K. · Salisu · S. · Gumbi · S. A. · Tanko · Z. L. · Umaru · H. M. · Bello-Manga · H. · Dogara · L. G. · Musa · A. · Usman · I. K. · Lawal · U. W. · Cleary · D. W.
Introduction

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

Methods and analysis

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethics and dissemination

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Impact of diabetes mellitus and body mass index on long-term survival in chronic total occlusion patients: a nationwide cohort study from the SCAAR registry

Por: Mohammed · M. · Sundström · J. · Louca · A. · Hellsen · G. · Rawshani · A. · Olivecrona · G. K. · Mohammad · M. A. · Ioanes · D. · Jensen · U. · Erlinge · D. · Angeras · O. · Petursson · P. · Myredal · A. · Völz · S. · Dworeck · C. · Odenstedt · J. · Rawshani · A. · Ramunddal · T.
Objectives

To evaluate the effects of diabetes mellitus (DM) and body mass index (BMI) on long-term all-cause mortality in chronic total occlusion (CTO) patients.

Design

Retrospective, nationwide cohort study.

Setting

Swedish Coronary Angiography and Angioplasty Registry, between June 2015 and December 2021.

Participants

24 284 patients with angiographically confirmed CTO. Prior coronary artery bypass graft surgery excluded. Subgroups were defined by DM status and BMI categories (underweight, healthy weight, overweight, obesity).

Primary outcome measures

Long-term all-cause mortality, assessed by Kaplan-Meier analysis and multivariable Cox proportional hazards regression.

Results

DM was present in 30.3% of patients and conferred a 31% higher risk of mortality (HR: 1.31, 95% CI: 1.20 to 1.42; p2, lowest risk (nadir) at 32 kg/m2 and modest rise above 35 kg/m2.

Conclusions

In this nationwide CTO cohort, DM independently predicted higher long-term mortality, accompanied by more severe comorbidities and greater CTO complexity, and insulin therapy further elevated hazard. Overweight and obese patients had better survival, while underweight individuals had the poorest prognosis. These findings underscore the importance of individualised risk assessment and management strategies in CTO patients, particularly those with DM or low BMI.

Is anaemia associated with QTc prolongation? A retrospective cross-sectional analysis from a rural population-based cohort

Por: Bazmi · S. · Mohammadi · Z. · Motazedian · M. · Tabrizi · R.
Background

Prolonged QTc is a major risk factor for ventricular arrhythmias and sudden cardiac death (SCD). Anaemia’s impact on the QT interval is unclear and conflicting despite its association with increased mortality.

Objective

We investigated the association between anaemia and the prevalence of QTc prolongation, as well as potential gender differences in this relationship. Additionally, we examined whether haemoglobin levels were associated with QTc prolongation.

Design

Observational cross-sectional study.

Setting

Sheshdeh, Fasa, Iran.

Participants

We analysed data from 5741 participants from the general population (aged 35–70 years) with no history of ischaemic heart disease; myocardial infarction; amiodarone use; multiple blood transfusions; or supplementation with iron, folic acid or cobalamin.

Primary and secondary outcomes

Anaemia was defined according to WHO guidelines (haemoglobin 450 ms in men or >470 ms in women.

Results

Among 5741 participants, mean QTc was 427.91±24.75 ms, with QTc prolongation in 7.14%. Anaemia raised the odds of QTc prolongation by 60% (OR=1.60, 95%CI 1.12 to 2.28, p=0.010), particularly in females (OR=1.73, 95%CI 1.12 to 2.66, p=0.013), but not in males. Higher haemoglobin levels were associated with lower QTc prolongation risk (OR=0.91 per unit increase, 95% CI 0.85 to 0.97, p=0.005). No significant associations were observed between anaemia type/severity and QTc prolongation among anaemic individuals.

Conclusion

Anaemia was significantly associated with QTc prolongation, particularly in females. Anaemia type/severity did not affect QTc prolongation. Anaemia is associated with increased odds of QTc prolongation, particularly in women. While causality cannot be inferred from this cross-sectional analysis, the findings suggest that clinicians may consider QTc monitoring in anaemic patients, especially women and exercise caution when prescribing QT-prolonging medications. Prospective studies are needed to confirm whether anaemia directly contributes to QTc prolongation or arrhythmic risk.

STRONG II trial: stereotactic body radiation therapy following chemotherapy for unresectable perihilar cholangiocarcinoma - a single-arm multicentre phase II study

Por: van Loosbroek · S. Y. · Milder · M. T. W. · de Ruysscher · D. · Vaes · R. D. W. · den Toom · W. · Willemssen · F. · Eskens · F. · Homs · M. Y. V. · Groot Koerkamp · B. · van Driel · L. M. J. W. · Seppenwoolde · Y. · van Werkhoven · E. · Intven · M. · Haj Mohammad · N. · de Bruijne
Introduction

For patients with perihilar cholangiocarcinoma (pCCA), surgical resection remains the sole treatment modality that can potentially result in cure. Unfortunately, the majority of patients present with unresectable tumours or are excluded from surgical treatment due to complications like cholangitis affecting their performance status. In the Netherlands, recommended first-line treatment for patients with unresectable pCCA is palliative chemotherapy with gemcitabine and cisplatin. This regimen yields an estimated median overall survival (OS) of 11.7–15.2 months, highlighting the urgent need for novel treatment options. The STRONG I trial, a phase I study in patients with unresectable pCCA, was completed in 2020. Its aim was to assess the feasibility and toxicity profile of adding stereotactic body radiation therapy (SBRT) to chemotherapy. SBRT, delivered in 15 fractions of 4.0 Gray (Gy), was considered to be feasible and safe, with no dose-limiting toxicity being observed. The 1-year local tumour control rate was 80% and the 1-year OS rate 100%, with maintenance of quality of life (QoL). These results encouraged us to initiate the STRONG II trial, aiming to investigate the efficacy of adding SBRT to chemotherapy in a larger patient cohort.

Methods and analysis

STRONG II is a single-arm, multicentre phase II study. Patients with non-metastatic unresectable pCCA (T1-4, N0-2) are eligible. A total of 30 patients will be enrolled in six academic centres in the Netherlands and two in Belgium. SBRT will be delivered in 15 fractions of 4.0–4.5 Gy. The primary endpoint is local tumour control, defined by Response Evaluation Criteria in Solid Tumours (RECIST) V.1.1. Secondary endpoints include toxicity, biliary stent-related events, progression-free survival, OS and QoL using the EuroQoL five-dimensional, five-level (EQ-5D-5L) questionnaire, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) and the EORTC Biliary Module (QLQ-BIL21). In addition, we will explore the predictive value of the peripheral immunological status (immune-related proteins and serum functional immunological status assay) and its dynamics in determining survival outcomes. For this explorative translational study, two blood samples will be collected, one before the start of chemotherapy and another after completing chemotherapy.

Ethics and dissemination

Approval of the study was obtained on 5 June 2024 by the Medical Ethics Review Committee of Erasmus Medical Center Rotterdam, the Netherlands (ID: NL86210.078.24). The anticipated time frame for patient enrolment is July 2024 to December 2027. The main study findings will be published in peer-reviewed medical journals, and presented at national and international conferences.

Trial registration number

NCT06493734 (ClinicalTrials.gov).

Prevalence of osteoporosis in prostate cancer survivor patients: a systematic review and meta-analysis protocol

Por: Ebrahimi · M. · Mohammadi · A. · Sarmadi · S. · Rahimnia · R. · Zare-Kaseb · A. · Reis · L. O. · Namazi Shabestari · A. · Aghamir · S. M. K.
Introduction

Osteoporosis is a skeletal condition with decreased bone mass and structural deterioration, increasing fracture vulnerability. Several studies have found a correlation between prostate cancer in men and an increased risk of osteoporosis. This study aims to determine the prevalence of osteoporosis in patients with prostate cancer.

Methods and analysis

The primary objective of this study will be to estimate the prevalence of osteoporosis in prostate cancer survivor patients. An extensive search will be conducted on PubMed, Scopus, Embase, Web of Science, CINAHL and ProQuest databases to ensure comprehensive coverage. The search will encompass the timeframe from 1 January 1994 to 24 September 2024. Furthermore, we will not impose any limitations on the language or geographical location of the published studies. In order to assess the potential bias in the included studies, the Joanna Briggs Institute critical appraisal checklist for prevalence studies will be employed. The analysis of data will be performed using STATA V.17. The prevalence of osteoporosis or osteopenia will be calculated for each study by dividing the number of participants with these conditions by the total number of patients diagnosed with prostate cancer. A subgroup analysis will examine prevalence regarding geographical location, age groups, ethnicity, definitions and measurements of osteoporosis or osteopenia, risk of bias in the included studies, type and duration of androgen deprivation therapy, and site of osteoporosis diagnosis. We will employ multiple methods to detect publication bias, including funnel plot analysis, Begg’s and Egger’s tests, and the Trim and Fill method. If we have enough data, we will conduct a sensitivity analysis using the leave-one-out-remove method.

Ethics and dissemination

No ethical approval or patient consent is required as this study synthesises only published aggregate data. Results will be disseminated via a peer-reviewed publication.

PROSPERO registration number

CRD42024600884.

Psychological birth trauma and its related factors, and providing strategies for prevention of psychological birth trauma: protocol for an explanatory sequential mixed-method study

Background

Childbirth can have psychological, social and emotional effects on women and their families. Psychological birth trauma (PBT) is defined as the emotional distress and mental health challenges resulting from negative or distressing experiences during the childbirth process. Labour management plays an important role in the health of women and children. Consequently, the study aims to assess the status of PBT among Iranian women, identify factors influencing it and suggest effective preventive strategies.

Methods and analysis

This study is a mixed-method research with an explanatory sequential approach. The first phase is quantitative and cross-sectional, involving 300 postpartum women visiting health centres in Tabriz-Iran. In this phase, cluster sampling will be used, and data will be collected using the following questionnaires: Sociodemographic and Obstetric Characteristics, Birth Trauma Scale, PTSD Symptom Scale 1, Perceived Quality of Care Scale, Childbirth Experience Questionnaire version 2.0, Edinburgh Postpartum Depression Scale, Postpartum Specific Anxiety Scale Research Short-Form and the questionnaire on the desire for subsequent pregnancy. The second phase is qualitative, and participants will be selected based on the results of the quantitative phase and extreme cases, using purposive sampling. Data analysis will be performed using qualitative content analysis with a conventional approach. Qualitative data will be collected through in-depth and semi-structured individual interviews with open-ended questions. In the third phase, strategies to prevent childbirth psychological trauma will be designed by integrating the results of the quantitative and qualitative studies, reviewing the literature and gathering expert opinions using a modified Delphi study. Examining PBT and its influencing factors can provide culturally relevant, evidence-based strategies. These strategies can be effective in improving the quality of care for women during childbirth.

Ethics and dissemination

This study has received approval from the Ethics Committee of Tabriz University of Medical Sciences in Tabriz, Iran (code number: IR.TBZMED.REC.1402.945). All participants will provide written informed consent before taking part in the study. The outcomes will be shared through articles published in journals, presentations at medical conferences, the validation of a reliable scale for assessing the level of PBT in postpartum women, and the provision of strategies to prevent childbirth psychological trauma. These resources will be valuable for policymakers and healthcare providers.

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