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Hoy — Octubre 14th 2025BMJ Open

Integrative exploration of bio-psycho-social determinants of DSM-5 severity levels of opioid use disorder: the BEBOP cohort study protocol

Por: Lalanne · L. · Lutz · P.-E. · Caparros-Roissard · A. · Ruppert · E. · Waeckerle · G. · Scherer · C. · Oster · F. · Brand · C. · Henck · S. · Soavelo · H. · Ramousset · C. · Lebreton · M. · Audran · M. · Lazic · J. · Detrez · V. · Avril · E. · Merah · I. · Chappuy · M. · Meyer · N. · Jauffret
Introduction

Opioid use disorder (OUD) is a chronic and severe psychiatric condition defined by a level of opioid use which significantly impairs interpersonal and social functioning. In the biopsychosocial model of addiction, research has shown that psychiatric, sociological and neurobiological factors individually affect OUD severity. However, how these factors interact in the determination of OUD severity remains poorly understood.

Method and analysis

The Epigenetic Bonds of Opioid Use Profiles are a multidisciplinary project whose primary objective is to characterise psychiatric and social factors of OUD in a large cohort of patients. The secondary objectives are, first, to correlate psychosocial severity with blood-derived epigenetic biomarkers to provide a deeper understanding of determinants of OUD and, second, to examine over a 2 year follow-up the correlation between the evolution of OUD and psychosocial severity with epigenetic biomarkers at inclusion. An additional objective is to analyse the impact of drug consumption rooms on access to care for most severely affected patients with OUD. In total, 300 opioid users will be recruited at supervised injection sites in Strasbourg and Paris and at addiction care centres in Strasbourg and Lyon to explore four psychiatric (substance use disorders beyond opioids, depression, anxiety, post-traumatic stress disorder) and five social (social support and status, traumatic experiences, housing, imprisonment, access to care) factors. Opioid users will be followed for 24 months and reassessed for psychosocial factors at 3, 6, 12, 18 and 24 months. Opioid consumption will be measured in all subjects using questionnaires, complemented by toxicological screenings (mass spectrometry). Finally, DNA methylation and gene expression will be characterised in capillary blood using next-generation sequencing. Mixed models will be used to model the primary and secondary outcomes.

Ethics and dissemination

This ongoing study was approved by the French Ethics Committee ‘Sud Méditerranée III’ of University Hospital of Nîmes (approval 2023–2024, protocol IDRCB number 2022-A02477-36) and authorised by the French Data Protection Authority (authorisation decision DR-2023–277 in December 2023). Results will be presented in international and national conferences and published in peer-reviewed international journals.

Trial registration number

NCT06021548.

AnteayerBMJ Open

Getting recovery right after neck dissection for head and neck cancer (GRRAND): trial protocol for a multicentre, pragmatic randomised controlled trial with health economic evaluation and process evaluation

Por: Evans · C. · Greene · L. · Hossain · A. · Klear · P. · Ratna · M. · Bradley · H. · Lall · R. · Mistry · H. · Naghdi · S. · Reategui · M. · Stevens · T. · Bruce · J. · Price · R. · Schache · A. · Dean · S. G. · Lamb · S. E. · Smith · T. · Winter · S. C.
Introduction

Head and neck cancer (HNC) affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year, over 12 000 people in the UK are diagnosed with HNC. Neck dissection is a key, surgical component of patient care. However, many people experience postoperative restriction in shoulder and neck movements, pain, fatigue and low mood, with only half ever returning to work.

Methods and analysis

Getting Recovery Right After Neck Dissection (GRRAND) is a two-arm, multicentre, pragmatic randomised controlled trial. The trial aims to compare clinical and cost-effectiveness of a personalised physiotherapy programme (GRRAND programme) versus usual practice, National Health Service (NHS), postdischarge care.

The planned sample size is 390 participants. Participants will be recruited from across UK sites and followed up for 12 months. The primary outcome is the shoulder pain and disability index at 12 months. Economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data, including pain, function, health-related quality of life, mental well-being, health resource use and adverse events, will be collected at 6 weeks, 3, 6 and 12 months, with exercise adherence at 6 weeks. A process evaluation will determine how GRRAND is implemented, delivered and received across clinical settings, exploring what works, for whom and under what conditions. Analysis will be on an intention-to-treat basis and reported inline with the Consolidated Standards of Reporting Trials statement.

Ethics and dissemination

The trial was approved by the London-Brent Research Ethics Committee (ref: 24/LO/0722) on 15 October 2024. Trial results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries and social media. This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials checklist.

Trial registration number

ISRCTN13855775.

Quadrivalent HPV Vaccine Evaluation Study with Addition of the Nonavalent Vaccine (QUEST-ADVANCE): protocol of an observational cohort study

Por: Middeldorp · M. · Donken · R. · Nirmal · A. · Smith · B. · Citlali Marquez · A. · Bettinger · J. A. · Brisson · M. · Burchell · A. N. · Dobson · S. R. · Dawar · M. · Franco · E. L. · Grennan · T. · Krajden · M. · Mayrand · M.-H. · McNeil · S. · Naus · M. · Sauvageau · C. · Singer · J. · Sm
Introduction

The Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE.

Methods and analysis

QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1–3 doses of the quadrivalent or nonavalent HPV vaccine at 9–14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9–14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4–5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20–27-year-old females vaccinated at 9–14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16–26 years of age up to 12 years postvaccination.

Ethics and dissemination

QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children’s and Women’s Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.

Translation and measurement properties of Persian version of Child-to-Parent Violence Questionnaire

Por: Abdolalipour · S. · Hosseinzadeh · M. · Khalili · M. · Asghari Jafarabadi · M. · Mirghafourvand · M.
Objective

Child-to-parent violence (CPV) has received limited attention in scientific literature, but due to a recent increase in reported cases, it has become a subject of investigation. The reliability and validity of the Child-to-Parent Violence Questionnaire (CPV-Q), in separate mother and father versions, have not yet been studied in Iran. This study aimed to assess the psychometric properties of the Persian CPV-Q.

Design

This research employed a cross-sectional design to evaluate the Persian CPV-Q’s psychometric properties. The process included translation (using backward-forward method), face validity (via impact score calculation), content validity (using content validity ratio (CVR) and content validity index (CVI)), construct validity (through exploratory and confirmatory factor analyses (CFA)) and reliability assessment (via test–retest, coefficient α, coefficient and intraclass correlation coefficient (ICC)).

Setting

The study was conducted at the Faculties of Tabriz University of Medical Sciences.

Participants

A total of 500 qualified students from Tabriz University of Medical Sciences were recruited using cluster random sampling. These participants completed the Persian CPV-Q.

Results

Face validity was confirmed, with impact scores exceeding 1.5 for all items. Content validity was strong, with CVR=0.92 and CVI=0.89. Exploratory factor analysis revealed four factors related to violence frequency and two factors regarding reasons for violence, consistent with the original questionnaire, covering 19 and 8 items, respectively. Total variance explained was 0.30 and 0.39 for the mother’s version and 0.33 and 0.43 for the father’s version in frequency and reason sections. The Kaiser-Meyer-Olkin test confirmed sample adequacy (

Conclusions

The Persian CPV-Q demonstrates adequate validity and reliability for assessing the prevalence and causes of CPV in Iranian society.

Prevalence of postpartum family planning uptake and its association with spousal discussion, joint decision-making and partner approval: a systematic review and meta-analysis

Por: Khurram · J. · Lal · A. · Rahim · A. · Tikmani · S. S.
Objective

This systematic review examined the prevalence of postpartum family planning (PPFP) uptake and its association with spousal discussion and husband’s support.

Design

Systematic review and meta-analysis.

Data sources

A comprehensive literature search was conducted across PubMed (NLM), Scopus (Elsevier), Web of Science (Clarivate) and Cochrane Library (Wiley).

Eligibility criteria

The review included primary observational studies published in English between January 2014 and March 2024. Eligible studies reported prevalence and association between spousal discussion, support, approval or contraceptive use by the husband in PPFP within 12 months of childbirth.

Data extraction and synthesis

Two reviewers independently screened the articles, performed data extraction and assessed the risk of bias using the Newcastle-Ottawa Scale and Appraisal Tool for Cross-Sectional Studies. Discrepancies were resolved through consensus. Random-effects meta-analysis estimated pooled prevalence, and pooled ORs of log odds were reported for the association between spousal discussion and partner approval and PPFP uptake.

Results

Six cross-sectional studies involving 2856 postpartum women were included. The pooled prevalence of PPFP uptake was 35% (95% CI 19% to 52%). Meta-analysis showed that spousal discussion was associated with PPFP uptake (log OR=1.39 (95% CI 0.65 to 2.13), however, partner’s approval was not associated with PPFP uptake (log OR=1.49, 95% CI –0.08 to 3.06). Two studies assessed partner support, with one reporting a significant association (log OR: 1.45); joint decision-making was assessed in two studies but showed no significant association with PPFP.

Conclusions

In conclusion, the overall prevalence of PPFP uptake is low. Spousal discussion plays a critical role in enhancing PPFP uptake. These findings highlight the need for policy initiatives and programmatic interventions that promote couple communication for PPFP decision-making to improve reproductive health outcomes in low–middle-income countries.

PROSPERO registration number

CRD42024505801.

Comparison of treatment efficacy between topical insulin and autologous serum in persistent epithelial defects: a randomised controlled trial protocol in Spain

Por: Arriola-Villalobos · P. · Burgos-Blasco · B. · Ascaso-del-Rio · A. · Medina-Ramirez · L. · Rivas · A. B. · Perez-Macias · N. · Diaz-Valle · D. · Portoles-Perez · A.
Background

Persistent epithelial defect (PED) management can be challenging. First line of treatment includes lubrication, bandage contact lenses and punctal plugs. The second line of treatment includes autologous serum (AS). Topical insulin has been shown to be safe for topical use and improve corneal epithelial healing. Therefore, a controlled clinical trial (control group with current standard treatment, ie, AS) multicentre, randomised and with a blind third observer will be conducted to evaluate the efficacy and safety of the use of insulin eye-drops in the treatment of PED.

Methods and analysis

A preselection of patients with epithelial defect after 1 week of treatment will be made and blood tests will be obtained in order to dispense AS if necessary. After 2 weeks of standard treatment, if the PED persists and the patient meets criteria, patients will be enrolled after signing an informed consent form. Patients will be randomly allocated to receive either insulin (1 UI/mL, 4 times a day) or AS (20%, 5–6 times a day) eye-drops for 3 months. 234 patients will be included, 117 in each treatment group. The main variable (PED size) will be obtained from slit-lamp photographs, an objective and easily quantifiable variable which will be evaluated by a blinded investigator (third observer). Patients will be examined every 3–5 days until week 4 of study treatment and once a week until 6 weeks, to continue with a visit every 2 weeks until reaching 3 months of follow-up. Primary endpoints are: complete epithelialisation, epithelialisation rate (initial defect area/days until epithelialisation) and time until complete closure.

Ethics and dissemination

Ethical approval has been obtained from Hospital Clinico San Carlos in Madrid and Agencia Española del Medicamento y Productos Sanitarios (AEMPS). The findings will be disseminated in peer-reviewed publications and presentations at meetings.

Trial registration number

EudraCT 2022-003589-19.

Mindfulness-based mHealth intervention for pregnant black and Latina women at high risk of postpartum depression--the Healthy Mama and Baby study: protocol and data overview for a randomised controlled trial in an integrated healthcare delivery system

Por: Kubo · A. · Kurtovich · E. · Aghaee · S. · Rubin · M. V. · Gomez Chavez · L. · Brown · S. D. · Ridout · K. · Bhalala · M. · Williams · A. · Elmer · M. · Ramsey · M. · Suazo · S. · Chess · A. · Quesenberry · C. P. · Avalos · L. A.
Introduction

Postpartum depression (PPD) is a debilitating condition affecting over 20% of postpartum women, with disproportionately higher rates among black and Latina women compared with their white counterparts. Current recommendations for PPD prevention demand significant healthcare system resources, highlighting the need for alternative, evidence-based interventions that minimise strain on these systems. Mindfulness has been shown to effectively reduce depressive symptoms and prevent relapse across various populations. However, no studies to date have evaluated the efficacy of a digitally delivered mindfulness intervention specifically for black and Latina women at increased risk of PPD.

This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based (mHealth) mindfulness intervention tailored for pregnant women reduces depressive symptoms among pregnant black and Latina women at high risk for PPD.

Methods and analysis

We are conducting a fully remote RCT, recruiting 600 pregnant black and/or Latina women at risk of PPD from Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system. Participants are enrolled before 30 weeks’ gestation. They are randomised into either an mHealth mindfulness intervention arm, which receives access to a mindfulness app tailored specifically for pregnant and postpartum women, or a time-matched and attention-matched active control arm, which receives access to an online program of calming nature sounds. Both arms are instructed to engage in their assigned program for 5–20 min per day for 6 weeks. Outcome assessments are conducted online at baseline, post intervention and post partum (~7 weeks post partum) using validated questionnaires. Outcomes include depressive symptoms (primary) and anxiety, sleep and perceived stress (secondary).

Ethics and dissemination

All study procedures have been approved by the KPNC Institutional Review Board. The findings will be disseminated widely through peer-reviewed publications and conference presentations.

Trial registration number

NCT05186272.

How ready are we for monkeypox (Mpox)? Monkeypox knowledge and preparedness among healthcare professionals in Rawalpindi district, Pakistan: a cross-sectional study

Por: Noor · M. · Ghazal · S. · Bilal · S. · Ali · B. · Anwar · A. · Jabeen · M.
Background

Monkeypox (Mpox) is an emerging public health concern globally as well as in Pakistan, with over 100 000 confirmed cases reported across 120 countries as of July 2024.

Objectives

To assess healthcare professionals’ knowledge and preparedness regarding Mpox and examine its association with demographic factors.

Study design

Quantitative, descriptive, cross-sectional study.

Study setting and duration

Conducted in tertiary care public sector hospitals of Rawalpindi district, Pakistan, from October 2024 to February 2025.

Participants’ selection

A total of 230 healthcare professionals of either gender, aged over 18 years, currently working in the public sector tertiary care hospitals of Rawalpindi district for at least 6 months were included.

Results

The mean age of the respondents was 29.13±6.55 years. The majority were women (147, 63.9%), post-graduate trainees (106, 46.1%), with 1–5 years of experience (184, 80%) and from medicine and allied disciplines (131, 57%). Most participants had an average level of knowledge regarding Mpox (137, 59.6%), with only a few demonstrating good knowledge (40, 17.4%). Half of the participants reported that their healthcare facilities lacked proper protocols for managing Mpox cases (97, 42.2%). Significant associations were observed between Mpox knowledge scores and participants’ field of specialty (p=0.007); notably, respondents from basic sciences had a higher proportion of good knowledge scores.

Conclusion

Overall, the level of knowledge and preparedness regarding Mpox among healthcare professionals was average. There is an urgent need for standardised Mpox preparedness protocols, outbreak response planning and comprehensive training programmes to enhance readiness for future outbreaks.

From unconditionality to disenchantment among primary healthcare professionals during the COVID-19 pandemic: a qualitative study from Madrid, Spain

Objectives

To explore the experience of primary healthcare (PHC) professionals in their professional role during the pandemic and to describe collective coping strategies.

Design

We conducted a qualitative study using interviews, focus groups and photovoice techniques from February to September 2021. The qualitative data were transcribed, aggregated and analysed, from a hermeneutic perspective, using applied thematic analysis and ethnographic approaches.

Setting

Primary Care Health Madrid region (Spain).

Participants

Convenience sampling was used to select 71 multidisciplinary primary care professionals who were working in 12 PHCs representing diverse socioeconomic, social vulnerability and COVID impact levels in the Madrid region (Spain).

Results

Findings from this study show how lack of protection in the early days, uncertainty about how the disease would evolve and the daily challenges they faced have had an impact on the participants’ perceptions of their professional role. Nuanced differences in impact were found between men and women, age groups, professional roles and territories. The questioning of the basic foundations of primary care and the lack of prospects led to a feeling of demotivation. They perceive a wide gap between their levels of involvement and commitment, the recognition they receive and the attention to resources they need to do their work to a high standard. The support of their colleagues was seen as the most valuable resource for coping with the crisis.

Conclusions

The practitioners’ discourses offer knowledge that could help to face new global health threats; they also identify an urgent need to restore the role and motivation of PHC professionals as part of a wider regeneration of health systems.

Online mindfulness interventions in the care of people with physical and mental health conditions: a scoping review

Por: Senthilnathan · V. · Zahir · S. · Simpson · R. · Jaglal · S. · Craven · C. · Fetterly · M.-J. · Perrier · L. · Munce · S.
Objective

With growing access to the internet, online mindfulness programmes have become more commonly used to manage physical and mental health conditions. This scoping review aims to determine the nature and extent of the literature, and key characteristics, of online mindfulness-based interventions (MBIs) for adults with physical or mental health conditions.

Design

A scoping review guided by the Joanna Briggs Institute framework.

Data sources

MEDLINE, CINAHL, Embase, PsycINFO, Allied and Complementary Medicine and the Cochrane Central Register of Controlled Trials.

Eligibility criteria

Studies focusing on online MBIs, online mindfulness-based stress reduction and online mindfulness-based cognitive therapy (MBCT) in adults with a physical or mental health condition were included.

Data extraction and synthesis

Study and participant characteristics, key intervention characteristics, outcome measures and results were abstracted.

Results

84 studies were included. Online MBIs have been studied in many different physical and mental health conditions; however, 63 of the included studies were for physical health conditions. MBCT was the most common intervention type assessed, with 33 of the included studies assessing it. Regarding intervention characteristics, intervention duration was similar across intervention type at 8 weeks, with sessions led by therapists, clinicians or mindfulness instructors. Web-based and videoconferencing were the most common delivery formats. Intervention content generally remained similar to standardised MBIs, with the addition of psychoeducation and disease management. Many studies did not report on tailoring the intervention to the participant population. There was a lack of consistency in reporting intervention characteristics.

Conclusions

This review highlights some evidence for online mindfulness programmes for both physical and mental health conditions. However, intervention componentry remains somewhat obscure, and reporting on tailoring appears relatively sparse. Greater consistency in reporting intervention componentry will improve knowledge and study in this area and enhance the translation of these interventions to clinical settings.

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