bluuebunny/crossref_metadata_2025 huggingface dataset:
Newly identified SpoVAF/FigP complex: the role in
Bacillus subtilis
spore germination at moderate high pressure and influencing factors
Authors: Lyu Fengzhi , Gong Ziqi , Zhang Tianyu , Yang Dong , Rao Lei , Liao Xiaojun
Published: January 2025

The SpoVAF/FigP complex, a newly identified dormant spore ion channel, has been shown to amplify the response of germinant receptors (GRs) to nutrient germinants. However, its contribution to high-pressure-induced germination remains unexplored. In this study, we discovered that the 5AF/FigP complex played an important role in the GR-dependent germination of
Bacillus subtilis
spores under moderate high pressure (MHP) by facilitating the release of ions, such as potassium (K
+
), a mechanism in parallel with its role in nutrient-induced germination. Despite its predicted function as an ion channel, the 5AF/FigP complex failed to be activated by MHP in the absence of GerA-type GRs. We quantitatively examined the factors that influence the 5AF/FigP complex’s function in MHP-induced germination using modeling and fitting techniques. Our results indicated that the complex’s amplification effect was both enhanced and accelerated as pressure levels increase from 50 to 200 MPa. However, raising the MHP treatment temperature from 22°C to 30°C only speeded up the complex’s function without enhancing its effectiveness. Moreover, extreme conditions of higher pressure (300 MPa) and temperature (34°C–37°C) could diminish the complex’s functionality. Additionally, the amplification effect was weakened in spores produced at both elevated and reduced sporulation temperatures. Taken together, our findings highlight the essential role of the 5AF/FigP complex in boosting the efficiency of MHP-induced germination. This revelation has enriched our understanding of the intricate mechanisms underlying GR-dependent germination in
Bacillus
spores, offering valuable insights that can be utilized to refine the germination–inactivation strategies within the food industry.

IMPORTANCE

High-pressure-induced spore germination has been discovered for more than half a century, but the signal transduction pathway of the process still needs to be refined. In this study, for the first time, we revealed the role of the newly identified SpoVAF/FigP complex in high-pressure-induced spore germination, as well as the factors influencing its function in this process. The new findings in this work not only enhance the theoretical understanding of spore germination mechanisms under high pressure but also pave the way for developing novel strategies to inactivate spores during high-pressure food processing, a technology that is gaining popularity in the food industry as a promising non-thermal preservation method.
Practice and factors affecting informed consent among healthcare workers for major surgical procedures at Gurage zone hospitals, South Ethiopia, 2022: a facility-based cross-sectional study
Authors: Zewudie Bitew Tefera , Tenaw Shegaw Geze , Mesfin Yibeltal , Abebe Haimanot , Mekonnen Zebene , Mengist Shegaw Tesfa , Chekole Bogale , Aynalem Agere , Lankrew Tadele , Sewale Yihenew , Argaw Muche , Sahle Tadesse , Tsega Daniel
Published: January 2025

Objective

This study aimed to assess the informed consent practice process and associated factors among healthcare workers for major surgical procedures at Gurage zone hospitals, in 2022.

Methods and materials

Institution-based cross-sectional study was employed.

Settings

This study was conducted in Gurage zone hospitals.

Participants

All healthcare workers who have been working in Gurage zone hospitals of surgical, operation rooms and obstetrics/gynaecology wards had exposure to patients who had undergone surgery during the study period

Outcome

The primary outcome of the study was the practice of informed consent practice among healthcare workers in Gurage zone hospitals.

Result

A total of 448 study participants were involved in this study giving a response rate of 98%. The mean (±SD) age of the study participants was 29.16 (±4.06) years. The mean score of study participants towards the surgical informed consent was 19.5, and 260 (58%, 95% CI: 53.7, 62.5) of them had good practice in the surgical informed consent. In multivariable logistic analysis model, factors like favourable attitude towards informed consent 2.4 (1.556, 3.596), work experience participants 4.9 (2.8, 8.7), adequate knowledge of informed consent 2.5 (1.6, 3.9) and communication challenge 1.6 (1.07, 2.50) were independently associated with the practice of informed consent at a p value of <0.05.

Conclusion

More than half of healthcare providers had good practice towards the surgical informed consent process. The practice of informed consent is low, and it is better to work on healthcare providers’ in-service training, knowledge and attitude towards informed consent.
Controlled ovarian hyperstimulation with or without letrozole for fertility preservation in breast cancer patients: study protocol for a randomised controlled trial
Authors: Xie Yanqiu , Li Ping , Deng Weifen , Fan Qi , Sun Peng , Kang Jiajing , Wang Kun , Shi Yuhua
Published: January 2025

Introduction

Multimodal anticancer therapies greatly damage the fertility of breast cancer patients, which raises urgent demand for fertility preservation. The standard options for fertility preservation are oocyte and embryo cryopreservation; both require controlled ovarian hyperstimulation (COH). However, there are safety concerns regarding breast cancer relapse due to the elevated serum estradiol levels during COH. Serum estradiol levels can be effectively decreased with the highly specific aromatase inhibitor letrozole. Letrozole is still uncommonly used during COH for fertility preservation, which has only been reported in a few studies, and the evidence of oocyte retrieval during ovarian stimulation and short-term safety from the perspective study is insufficient. As a result, this study will compare the efficacy of ovarian stimulation and the short-term safety of letrozole COH and non-letrozole COH protocols for preserving fertility in patients with breast cancer.

Methods and analysis

This is an open-label, multicentre RCT being conducted in five Chinese reproductive medical centres. 64 eligible patients diagnosed with breast cancer will be randomly assigned (1:1) to the letrozole or non-letrozole group during their COH cycles. The primary outcome is the number of mature oocytes. The secondary outcomes are the number of high-quality embryos, incidence of ovarian hyperstimulation syndrome(OHSS) and recurrence rate of breast cancer.

Ethics and dissemination

Ethical approval was obtained from the Ethics Review Committee of Guangdong Provincial People’s Hospital (KY-Q-2023-840-02). Written informed consent will be obtained from each participant. Findings will be disseminated to patients, clinicians and commissioning groups through peer-reviewed publications.

Trial registration number

ChiCTR2300078625
Systematic review of reviews on interventions to engage men and boys as clients, partners and agents of change for improved sexual and reproductive health and rights
Authors: Gottert Ann , Pulerwitz Julie , Weiner Renay , Okondo Chantalle , Werner Jesse , Magni Sarah , Mathur Sanyukta
Published: January 2025

Objectives

Evidence regarding interventions to engage men and boys to improve sexual and reproductive health and rights (SRHR) has grown rapidly across subtopics such as HIV, family planning and gender-based violence (GBV). We conducted a review of the effectiveness of interventions to engage men and boys across SRHR domains, lessons learnt about successful programming, and about harms/unintended consequences, in low- and middle-income countries (LMIC).

Design

Systematic review of reviews following Cochrane guidelines.

Data sources

PubMed, Cumulative Index to Nursing and Allied Health Literature, Web of Science and Cochrane were searched (18 October–9 November 2022; 9 September 2024).

Eligibility criteria

Eligible reviews were published since 2015, covered WHO-defined SRHR domain(s) and focused mostly on LMIC.

Data extraction and synthesis

Data extraction by multiple reviewers focused on intervention effectiveness, implementation best practices, unintended consequences, and quality/risk of bias.

Results

Thirty-five systematic reviews were included, comprising ~960 primary studies. Reviews focused on HIV prevention/care, reproductive health, maternal and newborn health, and GBV. Reviews consistently concluded that men were successfully engaged, yielding benefits to both women and men’s SRHR outcomes; no adverse intervention impacts on prevalence of SRHR outcomes were reported. We summarised the interventions most consistently found to be effective across reviews, in a programmer-friendly visual mapped onto a framework of men as clients, partners and agents of change. Person-centred, gender-transformative, multilevel approaches were most effective. Remaining evidence gaps include engaging men as contraceptiveusers, sexually transmitted infections other than HIV, preventing unsafe abortion and SGBV as experienced by men and boys.

Conclusions

There is substantial evidence supporting a range of successful interventions to engage men and boys to improve SRHR, with markedly similar principles and approaches emerging across SRHR domains. It is time to scale up and integrate these strategies, monitoring for any potential harms and tailoring as needed to socio-cultural contexts and for specific vulnerable subpopulations.
Specialty choice among final-year medical students and house officers in Nigeria: implications for anaesthesia practice – a cross-sectional study
Authors: Okonkwo Thankgod Chukwunnonso , Olatunji Gbolahan Deji , Adeleye Victor Mayowa , Akinwale Mukaila Oyegbade
Published: January 2025

Objectives

Nigeria’s doctor shortage is worsening with mass exodus and imbalanced specialty distribution. Anaesthesia faces particularly critical shortages. Medical graduate specialty choices have a vital impact on the workforce and are essential for healthcare planning. This study aimed to identify the current specialty preferences of final-year medical students and house officers in Nigeria, factors that affect such choices, and their implications for anaesthesia practice.

Design

We conducted a cross-sectional study among final-year medical students and house officers in Nigeria using a self-administered, semistructured electronic questionnaire. The survey question was divided into four sections: sociodemographic data, specialty preferences, factors considered in choosing a specialty, perception of anaesthesia posting and anaesthesia as a specialty.

Setting

The survey was delivered via a Google Form that had been active for 4.5 months.

Participants

A total of 760 valid responses were received from final-year medical students and house officers in Nigeria. The majority (63.82%) of the participants were final-year medical students.

Results

Surgery (26.58%), internal medicine (14.47%) and obstetrics and gynaecology (14.34%) were the top-ranking specialty choices. Only 3.55% (eighth in ranking) intended to specialise in anaesthesia. There was a positive correlation between respondents’ specialty choice and the specialty of their doctor role model. Passion/interest, flexibility, potential future income and job prospects were essential in choosing a specialty. Most decisions were made during clinical rotations (63.95%), and only 35.26% had career guidance. Many enjoyed their anaesthesia posting, but over half felt the exposure was inadequate.

Conclusions

Too few medical graduates in Nigeria prefer anaesthesia as a specialty, and there is an urgent need to increase interest. A lack of career counselling, anaesthetist mentors and satisfactory clinical rotations are factors that can be improved for better recruitment into anaesthesia.
Magnitude of opportunistic infections and associated factors among HIV-infected individuals attending care and treatment clinics in Dar es Salaam, Tanzania: a hospital-based cross-sectional study
Authors: Njelekela Doris Andrew , Kishimba Rogath , Noah Mololo , Kamori Doreen , Majigo Mtebe , Joachim Agricola
Published: January 2025

Objectives

This study aims to assess the magnitude of opportunistic infection (OI) and to identify factors associated with OIs among people living with HIV (PLHIV) on antiretroviral treatment (ART), attending HIV care and treatment clinics.

Design

A hospital-based cross-sectional study.

Setting

The study was conducted at Muhimbili National Hospital, Mwananyamala and Temeke Regional Referral Hospitals, in Dar es Salaam, Tanzania.

Participants

We enrolled 382 PLHIV on ART who were attending HIV care and treatment clinics in Dar es Salaam. Structured questionnaires were used to collect socio-demographic information, and a checklist was used to extract clinical characteristics from the client’s HIV care and treatment clinic cards. Information was subjected to descriptive and regression analysis using Stata V.13. All factors were considered significant at p<0.05.

Primary outcome

Magnitude, spectrum of OI and associated factors among PLHIV using ART.

Results

A total of 382 PLHIV on ART were randomly selected and recruited in the study. The overall prevalence of OIs was 25.13%; the leading OI was tuberculosis affecting 58 patients (15.2%). CD4+ T cell counts≤200 cells/µL (aOR=13.61; 95% CI: 6.09 to 30.38) p<0.001, isoniazid preventive treatment (IPT) (aOR=4.10; 95% CI: 1.97 to 8.53) p<0.001, WHO clinical stage 4 (aOR=6.37; 95% CI: 1.47 to 27.61) p=0.013, divorced individuals (aOR=3.57; 95% CI: 1.43 to 8.90) p=0.006, male (aOR=3.04; 95% CI: 1.50 to 6.17) p=0.007, haemoglobin level<11.0 g/dL (aOR=2.25; 95% CI: 1.14 to 4.47) p=0.020 and level of education of primary and below (aOR=4.31; 95% CI: 1.8 to 10.32) p=0.001 showed significant association with OIs.

Conclusion

There was still a high prevalence of OI observed in this study which needs to be addressed. CD4+ T cell counts of ≤200 cells/µL, advanced WHO clinical stages, no use of IPT prophylaxis, anaemia and low education level were predictors of OIs. Promptly implementing the test-and-treat protocol while an individual’s immunity is still strong and timely screening for OI are critical.
Association of quality of life in older patients with breast cancer: a cross-sectional study from China
Authors: Xiao Min , Ji Lei , Qian Xiaoyan , Chen Xi , Xiu Meng , Li Zhuoran , Cao Heng , Chen Shanshan , Li Qing , Li Qiao , Wang Xiang , Wang Jiani , Li Yiqun , Zheng Xiaojuan , Zhang Jintao , Zhang Pin
Published: January 2025

Objectives

The purpose of this study was to investigate the quality of life (QoL) of older Chinese patients with breast cancer and to explore further the associations of functions, symptoms, financial burdens and comorbidities with global health/quality of life (gQoL).

Design

This was a cross-sectional study carried out following the Strengthening the Reporting of Observational Studies in Epidemiology checklist.

Setting

This study was conducted in two hospitals in Beijing from October 2021 to November 2022.

Participants

Patients with breast cancer aged over 65 years were included in the final analysis, which comprised a total of 481 patients.

Primary and secondary outcome measures

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the Charlson Comorbidity Index (CCI) were used to assess patients’ QoL and comorbidities. The data were analysed using network analysis and path analysis.

Results

Out of the 136 possible edges in the final networks, 84 (61.8%) were non-zero. ‘Fatigue’ was the central symptom and indirectly decreased the gQoL, which was mediated by increasing ‘financial difficulties’, ‘CCI’ and ‘role function’ (β = −0.35, p<0.001). ‘Physical function’ was also an important and direct intervention node that was indirectly related to gQoL, and this was mediated by ‘role function’ (β = −0.15, p=0.006). Path analysis accounted for 32.0% of the total effect.

Conclusions

The various dimensions of QoL are highly interrelated and mutually reinforcing. These results highlight the importance of improving the fatigue and physical function of older patients with breast cancer. Interventions targeting these symptoms may lead to an overall improvement in gQoL.

Trial registration number

ChiCTR2200056070; Public title: Frailty and Comorbidity in the Elderly Study (FACE Study).
Factors protecting against progression of myopia in school students exposed to societal change in Vietnam: a 3-year cohort study
Authors: Tran Xuan Minh Tri , Nguyen Hoang Thuy Linh , Tran Thao Vi , Seino Kaoruko , Ohno-Matsui Kyoko , Igarashi-Yokoi Tae , Vo Thang Van , Nakamura Keiko
Published: January 2025

Objectives

To elucidate the incidence of myopia, progression of refractive error, axial length (AL) elongation and factors associated with myopia in secondary school students in Vietnam.

Design

Prospective cohort study.

Settings

Hue Healthy Adolescent Cohort Study, Hue City, Vietnam.

Participants

3-year longitudinal data were available for 355 secondary school students (mean age 11.60±0.36, 46.8% girls). Noncycloplegic refraction and AL measurements were performed at baseline and the 3-year follow-up examinations.

Primary and secondary outcome measures

The primary outcomes were myopia incidence and progression. Myopia, emmetropia and hyperopia were defined as spherical equivalent (SE)≤−1.0 diopters (D), −0.5 D<SE < +0.5 D and SE ≥ +0.5 D in the right eye, respectively. The cumulative incidence of myopia was defined as the proportion of students who were not myopic at baseline but who subsequently developed myopia during the follow-up period. Factors associated with myopia incidence and progression were analysed using logistic and linear regression models, respectively.

Results

Baseline mean SE and AL were −0.94±1.66 D and 23.36±0.93 mm, respectively. The cumulative and annual incidences of myopia were 40.6% and 12.5%, respectively. Spending more time outdoors was associated with a significantly decreased incidence of myopia (adjusted OR 0.499; 95% CI: 0.329–0.757), less myopic SE progression (β=0.337; 95% CI: 0.254, 0.640) and slower AL elongation (β=−0.289; 95% CI: −0.202 to –0.071). In contrast, a study using computers was significantly associated with greater myopic progression in SE (β=−0.184; 95% CI: −0.699 to –0.112) and AL elongation (β=0.208; 95% CI: 0.062, 0.263).

Conclusion

This longitudinal assessment revealed both myopia incidence and progression and identified myopia-risk and myopia-protective behavioural factors in a Vietnamese cohort of secondary school students. The results highlight the high prevalence and considerable incidence of myopia, and the need for further effective strategies to reduce the risk of myopia by managing computer time and increasing outdoor time.
What should be publicly funded in the Colombian health system? A mixed methods study of citizens’ perceptions
Authors: Vélez Claudia Marcela , Díaz-Hernández Diana Patricia , Velázquez-Salazar Pamela , Hernández-Herrera Gilma , Patiño-Lugo Daniel Felipe , Salazar-Blanco Olga Francisca , Rodríguez-Corredor Leydi Camila , Vélez-Marín Viviana María , Velásquez Juan Carlos , Jaramillo-García Anny Julieth
Published: January 2025

Background

In recent years, citizens have become more interested and willing to influence health policy decision-making, and governments worldwide are more prone to citizen engagement in such processes. Prioritising which health technologies should be publicly funded is one decision that requires prudence and consideration of the values and expectations of the people who will be affected by it.

Objective

To identify and understand the citizens’ perceptions about which health technologies should be publicly funded in Colombia.

Design

Sequential exploratory mixed methods study; the first was a qualitative embedded case study, and the second was a Q methodology study.

Participants

46 citizens were interviewed, and 30 citizens ordered a Q-sample of 45 statements.

Analysis

Interviews were content analysed. We performed a content analysis of the interviews, and, for the quantitative strand, we performed a principal component analysis and varimax rotation to identify view patterns. We also estimated the z-scores of each statement and the load to each factor. We jointly interpreted both sets of findings.

Results

We identified two general approaches citizens used to consider public funding of healthcare technologies. One approach endorsed full coverage of all health technologies required by every Colombian. In the second approach, public funding is conditional on the characteristics of the person who needs the technology, their disease/condition, the kind of technology required and the expectation of efficient health system performance. When integrating the results of the Q methodology, we found five patterns of points of view about the public funding of health technologies.

Conclusion

Colombian citizens consider and balance a range of different factors when making decisions about which health technologies are publicly funded. Citizens not only use technical criteria to decide but also provide the perspective and values of those affected by the decision.
Seeking abortion medications online: experiences from a mystery client study in Colombia
Authors: Arango Daniel Arango , Cartwright Alice F , Braccia Ava , Moore Ann , Vivas Maria M
Published: January 2025

Objectives

While Colombians gained broad legal access to abortion in 2022, people still lack knowledge about its availability and face variable quality of care at health facilities. This study sought to understand whether online sellers provide the instructions and medication dosages necessary for effective medication abortions.

Design

The study design involved mystery clients contacting sellers identified across websites and social media platforms (Facebook, Instagram, and TikTok) to purchase abortion pills. Unique sellers were contacted with two profiles (first and second trimester pregnancy gestational ages). Mystery clients documented information received on physical effects, complications and how to take the pills from the sellers in a predesigned survey in SurveyCTO.

Setting

The study was conducted in Colombia from July to September 2023. We documented and described sellers’ conversations with mystery clients and pills received. We identified 161 sellers across platforms, which resulted in 65 unique sellers after deduplication. We attempted to contact each unique seller twice.

Results

Almost all sellers screened for gestational age using last menstrual period. Bleeding (84.6%) and cramping (66.7%) were the physical effects most commonly mentioned to mystery clients, although pain was mentioned to second trimester clients more often than first (40.5% vs 22.0%). Less than 17% of sellers highlighted possible complications that could require medical attention. Almost 90% of purchases were received (88.9%). All contained manufacturer-branded misoprostol and 77.5% were undamaged aluminium blister packages. While 82.6% of first trimester clients were instructed to take an initial misoprostol dosage in line with Colombia’s Ministry of Health guidelines, all second trimester clients were told to take a dosage exceeding the recommended amount. Although most sellers provided appropriate information on administration routes for the pills, sellers also provided contradictory and unnecessary instructions.

Conclusion

Online sellers of abortion pills may persist even as legal abortion becomes more widely available in Colombia. While misoprostol was received from many of these sellers, they did not provide sufficient information about potential complications or accurate dosing instructions to second trimester clients. Accurate medication abortion information specific to Colombia should be made more accessible so that people can more easily navigate the new care landscape.
Preoperative carcinoembryonic antigen to lymphocyte ratio serves as a prognostic predictor in elderly patients with colorectal cancer: a multicentre retrospective study
Authors: Liang Tao , Jiang Jiayi , Li Xinyi , Ma Haohan , Zhang Xiaonan , Deng Gang , Deng Weiping , Guan Lichang , Zhang Kaijun , Jiang Lei , Tan Ning , Cai Xujie , Xu Lishu
Published: January 2025

Objectives

The aim of this study is to derive and validate a reliable indicator for predicting an increased risk of postoperative mortality in elderly patients undergoing curative resection for colorectal cancer (CRC).

Design

This study is of multicentre retrospective design.

Setting and participants

A total of 1227 CRC patients undergoing curative resection (age ≥65 years) from three distinct cohorts were retrospective enrolled. Participant cohorts consisted of the derivation (n=845), external validation (n=95) and localised validation (n=287) groups. The carcinoembryonic antigen (CEA) to lymphocyte ratio (CLR) was derived from the derivation cohort and subsequently validated in two additional cohorts. The observed end point was all-cause death during the follow-up period postoperation.

Results

In the derivation cohort, CLR demonstrated an independent association with all-cause mortality. In the two validation cohorts, CLR also presented a strong discriminatory ability in predicting postoperative all-cause death, with the area under the curve (AUC) of 0.68 in the external cohort and 0.78 in the localised cohort. Survival analyses revealed that CRC patients with CLR ≤2.53 tended to have better overall survival than those with CLR >2.53 (p<0.05 for all cohorts). Multivariate Cox proportional hazard models indicated that CLR ≤2.53 was significantly associated with reduced mortality risk in the derivation (HR: 0.405, p<0.001), external validation (HR: 0.519, p=0.039) and localised validation cohorts (HR: 0.167, p<0.001).

Conclusions

Preoperative CLR serves as a reliable predictor of all-cause death following curative resection in elderly patients with CRC. Individuals with CLR exceeding 2.53 are inclined to a lower overall survival probability.
Chronic kidney disease progression in patients with previous type 2 diabetes and/or hypertension: a population-based cohort study from primary care in Spain
Authors: Cunillera-Puértolas Oriol , Vizcaya David , Cobo-Guerrero Sílvia , Romano-Sánchez José , Bundó-Luque Daniel , Arbiol-Roca Ariadna , Salvador-González Betlem
Published: January 2025

Objectives

To evaluate whether between hypertension and type 2 diabetes (T2D)—established drivers of chronic kidney disease (CKD) progression—one might be more strongly associated with CKD progression than the other.

Design

Cohort study using a primary care database (electronic health records).

Setting

Primary care in Catalonia, Spain.

Participants

438 273 patients with CKD identified from the Information System for Research in Primary Care database in Catalonia (2007–2017) and stratified into four mutually exclusive groups based on the presence/absence of hypertension and/or T2D. Distribution of the CKD study cohort was as follows: CKD with hypertension (51.1%), CKD with T2D (3.9%), CKD with hypertension and T2D (32.8%), CKD without hypertension and T2D (12.2%).

Primary and secondary outcome measures

Patients were followed up to identify the occurrence of severe kidney impairment (SKI) and kidney failure (kidney replacement therapy/estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2). Subdistributional hazard ratios (sHRs) were estimated using Cox regression adjusted for confounders.

Results

Compared with the CKD without hypertension and T2D group, adjusted sHRs (95% CIs) for SKI/kidney failure were 1.77 (1.65 to 1.89) for CKD with hypertension and T2D, 1.50 (1.41 to 1.59) for CKD with hypertension and 1.21 (1.09 to 1.34) for CKD with T2D, and for kidney failure were 1.24 (1.10 to 1.39) for CKD with hypertension, 0.74 (0.61 to 0.90) for CKD with T2D and 1.09 (0.96 to 1.24) for CKD with hypertension and T2D. The strongest risk factors for CKD progression were low eGFR and albuminuria, even at mild-moderate levels.

Conclusions

Hypertension could be associated with an equal/greater risk of CKD progression as T2D. Efforts to slow CKD progression should target both patients with hypertension and T2D, focusing on the identification, close monitoring and effective management of albuminuria and reduced eGFR.
Protocol for a multicentre, prospective, open-label, randomised controlled trial to compare PROs and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction via a deep inferior epigastric perforator flap (CAPPELLA) in China
Authors: Hao Shuang , Hou Jianjing , Zhang Li , Zhou Changming , Hou Yifeng , Yu Keda , Hu Zhen , Liu Guangyu , Di Genhong , Shao Zhi Min , Yu Xiaoli , Wu Jiong
Published: January 2025

Introduction

Despite its therapeutic advantages, postmastectomy radiotherapy (PMRT) increases the risk of complications and often leads to poor cosmesis in women undergoing breast reconstruction. Preoperative radiotherapy followed by skin-sparing mastectomy and deep inferior epigastric perforator (DIEP) flap reconstruction is technically feasible, with low rates of surgical complications and good short-term oncological outcomes. Further evaluation in a randomised trial comparing preoperative radiotherapy versus conventional PMRT in breast reconstruction is required to assess both oncological and patient-reported outcomes (PROs).

Methods and analysis

The CAPPELLA trial is a prospective, multicentre, open-label, randomised controlled trial across nine centres comparing PROs and safety outcomes between preoperative and postoperative radiotherapy in patients with locally advanced breast cancer requiring immediate DIEP flap reconstruction. Female patients aged >18 years with breast cancer who are treated with neoadjuvant systemic treatment, require both mastectomy and radiotherapy and are suitable for DIEP flap reconstruction will be included. Patients will be randomly assigned (1:1) to a preoperative radiotherapy group or a postoperative radiotherapy group. Stratification will be performed by cancer centre at initial diagnosis. The radiation volumes will include the ipsilateral breast/chest wall, supraclavicular lymph nodes, undissected axilla and internal mammary nodes. The dose regimen will be 42.56 Gy in 16 fractions. The primary endpoint will be satisfaction with the breast domain of the BREAST-Q at 2 years postoperatively. The secondary endpoints will include PROs at 3, 12 and 24 months postoperatively in both groups, aesthetic assessment, complication rates, rates of total pathological complete response (tpCR) and tumour safety. All patients will be followed up for 36 months postoperatively. The app software will be used to collect all data prospectively. Data will be analysed using SPSS and Stata software. The target sample size will be 80 participants.

Ethics and dissemination

This study will be performed according to the Helsinki Declaration. All patients will be asked to provide informed consent before enrolment. Approval for this study was provided by the independent ethics committee and institutional review board of Fudan University Shanghai Cancer Centre. We will present the study results at national and international meetings and publish them in a scientific peer-reviewed journal.

Trial registration number

NCT05512286.
Medical complexity in emergency and urgent care settings: a scoping review protocol
Authors: Bele Sumedh , Chisolm Cassandra , Lategan Conne , Yakubets Kate , Lorenzetti Diane , Uwamahoro Marie-Claire , Popeski Naomi , Turin Tanvir C , Lang Eddy , Rabi Doreen
Published: January 2025

Introduction

Considering the impact of non-medical factors (personal and social) on patients with multiple chronic conditions, the term ‘medical complexity’ is gaining traction as it encompasses both medical and non-medical aspects of patients’ medical needs. When primary care is not able to provide timely care for chronic challenges or acute concerns, complex patients require care in emergency or urgent care settings. The concept of medical complexity is continually evolving, although without a universally accepted or standardised definition that determines if an adult patient is considered complex. Therefore, this scoping review aims to understand how medical complexity is defined, identify its defining attributes and examine its use in clinical care research. We also aim to consolidate and evaluate the evidence to suggest a more comprehensive and standardised definition of medical complexity and/or highlight key components required to define medical complexity in urgent care and emergency department settings.

Methods and analysis

This protocol is developed according to the approach described by Arksey and O’Malley (2005) and expanded by Levac and colleagues. We will use Walker and Avant’s method of concept analysis (2005) to gain a comprehensive understanding of the concept of medical complexity. We will systematically search MEDLINE, CINAHL Plus, EMBASE, APA PsycINFO and Cochrane Library. A grey literature search will be conducted in Google and Google Scholar to identify additional information. Two reviewers will independently screen titles and abstracts for inclusion, followed by a screening of the full text of potentially relevant articles. Relevant data will be extracted from these studies. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist will be used to report the selection of studies at different stages.

Ethics and dissemination

Scoping review methodology uses and reviews publicly available studies and data, so ethics approval is not required. We will disseminate the results of this scoping review through peer-reviewed publications and presentations at academic conferences and scientific meetings. We will also share these results with key stakeholders, including healthcare providers, community organisations and healthcare system leaders.
Women’s experiences of living with adenomyosis and perceptions of the diagnostic journey: a scoping review
Authors: Taylor Margaret A , Croudace Tim J , Muir Fiona E , McBride Margot
Published: January 2025

Objectives

Uterine adenomyosis is a common gynaecological disease that can be debilitating. It is poorly understood and may be overlooked in clinical settings. A research gap exists as there are currently no published scoping reviews on perceptions and experiences early in the illness course. As part of a professional doctorate thesis, the aim of this review is to systematically retrieve and describe available literature, exploring the impact of living with adenomyosis and perceptions of the diagnostic journey.

Design

A scoping review is conducted using JBI methodology.

Data sources

Medline, CINAHL Plus, Web of Science, Google Scholar, Cochrane library, JBI and PROSPERO databases, EThOS online and Google. Searches were made from database inception to July 2023.

Eligibility criteria

The characteristics of the evidence sourced were deliberately broad. Studies exploring the experiences and perceptions of women diagnosed with adenomyosis were considered.

Data extraction and synthesis

Titles and abstracts were initially screened. Subsequently, eligibility was clarified through methods section inspection, and the remaining studies were read in depth. A manual hand-search of references of selected studies was conducted. Prespecified data were extracted, charted and categorised into themes.

Results

Six eligible studies were found, with themes describing impact and burdens, as well as several categories of unsupported needs. No studies specifically focused on perceptions of the diagnostic journey, but some eligible studies made minor reference to this and are included.

Conclusions

This review highlights the profound impact of adenomyosis and is the first to explore the lived experiences and the diagnostic journey. Understanding the burdens of disease in terms of perceptions and lived experience in combination with the experiences of diagnostic interactions is vital to improving diagnostic pathways. Education with improved multidisciplinary collaboration and further qualitative and case study research will be crucial to achieve this goal.

Registration

A priori protocol was registered (https://doi.org/10.17605/OSF.IO/2UDYN) and published (https://doi.org/10.1136/bmjopen-2023-075316).
A nested case-control study evaluating the relationship between adverse childhood experiences and immune-mediated inflammatory disease in the Canadian Longitudinal Study on Aging
Authors: O'Mahony Julia , Bernstein Charles N , Marrie Ruth Ann
Published: January 2025

Objective

Adverse childhood experiences (ACE) have inconsistently been implicated as risk factors for immune-mediated inflammatory diseases (IMID). We evaluated whether the association of ACE with disease differs between IMID and other chronic diseases.

Design

Nested retrospective case-control study.

Setting

We used data from the Canadian Longitudinal Study on Aging (CLSA), which recruited participants aged 45–85 years between 2010 and 2015.

Participants

We included 12 627 CLSA participants: 2 102 who reported diagnoses of IMID (258 multiple sclerosis (MS), 1 692 rheumatoid arthritis (RA) and 160 inflammatory bowel disease (IBD)), 5 519 with diabetes, 170 with epilepsy, 3 889 with asthma and 1 125 with no chronic diseases. ACE, including childhood maltreatment (physical, emotional and sexual abuse, neglect) and household dysfunction, were queried using questions from the Childhood Experiences of Violence Questionnaire-Short Form and the National Longitudinal Study of Adolescent to Adult Health Wave III questionnaire.

Primary and secondary outcome measures

We first evaluated whether the association of maltreatment differed across diagnoses (IMID, diabetes, asthma, epilepsy, no chronic diseases). Second, we evaluated whether the association between maltreatment differed across IMID. We repeated our analyses for different types of ACE.

Results

Maltreatment or household dysfunction was experienced by 64% of participants and 30% experienced both. On multivariable analysis, history of any maltreatment, sexual abuse, any household dysfunction and having ≥3 types of ACE were all associated with increased risk of IMID compared with no chronic disease. The association between ACE and IMID did not differ across MS, RA and IBD.

Conclusion

ACE are common among Canadians with and without chronic diseases. History of any maltreatment or household dysfunction is associated with increased risk of chronic disease.
Effectiveness of the ARTHE-e app for exercise adherence in people with knee osteoarthritis: protocol for a randomised controlled trial
Authors: Pelletier-Visa Mathilde , Dobija Lech , Bonhomme Alexis , Lanhers Charlotte , Pereira Bruno , Coudeyre Emmanuel
Published: January 2025

Introduction

Osteoarthritis, the most prevalent joint disease, poses a significant challenge due to its progressive nature and impact on the whole joint and periarticular structures. Although exercise is crucial for symptom improvement and progression slowdown, adherence to exercise programmes remains a concern. In response, we have developed a novel smartphone-based m-health application, ARTH-e, specifically designed to enhance adherence to adapted physical activity in individuals with knee osteoarthritis. We aim to perform a prospective,multicenter, randomized (1:1) controlled trial to compare the effectiveness of m-health application ARTH-e (intervention group) with standard care (control group) on exercise adherence in people with knee osteoarthritis. We hypothesise that adherence will be stronger among users of the ARTH-e application.

Methods and analysis

We will recruit 120 participants from 5 hospitals in France. The participants will undergo a comprehensive assessment, including the Exercise Adherence Rating Scale (EARS) at 2, 4 and 6 months, Knee Injury and Osteoarthritis Outcome Score, Evaluation of the Perception of Physical Activity, Tampa Scale of Kinesiophobia, European Quality of Life 5 Dimensions and 3 Lines and a Visual Analogue Scale rating of pain at baseline and 6 months. Adherence will be monitored using a connected bracelet. The intervention group will use the ARTH-e application for 6 months, while the control group will follow stay-active advice from their physician. The primary outcome will be the difference between groups in the evolution of the EARS score at 6 months.

Ethics and dissemination

The study has been approved by the medical ethics committee (Comité de Protection des Personnes) XI of Saint Germain en Laye (27 March 2024) (ID for ethics approval: 24.00330.000201). Eligible individuals will sign the informed consent form before enrolment. Study results will be reported in peer-reviewed publications and at scientific meetings.

Trial registration number

NCT06359171.
Improving health outcomes by strengthening public sector capacity in social and behaviour change programming in Nigeria: a qualitative study
Authors: Adetunji Adetayo , Addo Bright , Abegunde Dele , Kalamar Amanda , Tulsiani Nrupa Jani , Sripad Pooja , Oyedokun-Adegbabo Foyeke , Ankomah Augustine
Published: January 2025

Objective

This paper examines the outcomes of the public sector capacity strengthening (PSCS) approach and how they contribute to the promotion of maternal, newborn, and child health, and nutrition (MNCH+N), family planning (FP) and malaria prevention-related outcomes.

Design

The qualitative study implemented from July to August of 2022 used the outcome harvesting methodology and key informant interviews to elicit information including most significant change (MSC) stories to evaluate project outcomes over 5 years (2017–2022).

Setting

The study was conducted in Sokoto, Kebbi, Nasarawa, Bauchi and Ebonyi states of Nigeria.

Participants

The study focused on public sector stakeholders who were exposed to the PSCS intervention and were selected from government agencies. Nine study participants were engaged per state, bringing the total number of participants to 45. Data were analysed thematically and elicited MSC stories were analysed for content.

Results

The PSCS approach empowered stakeholders at the individual level to disseminate MNCH+N, FP and malaria prevention messages, monitor health and social and behaviour (SBC) activities and increase the demand for health services. At the organisational level, the approach facilitated coordination of SBC activities, enabled training cascades and promoted adherence to health service guidelines. At the system level, it strengthened ward development committees to address health challenges. Challenges hindering stakeholders’ application of PSCS-acquired skills include inadequate workforce, negative attitudes of health workers, funding constraints, cultural barriers, lack of government ownership and limited accessibility.

Conclusions

This study shows that the PSCS approach is an effective model to scale up capacity for SBC in MNCH+N, FP and malaria prevention programmes. In response to documented supply-side challenges impeding the application of gained knowledge and skill, we recommend inclusive health worker recruitment, sensitisation programmes for health workers, government ownership, improved security, healthcare infrastructure and transportation systems.
Clinicopathological characteristics and survival outcomes of women aged ≤45 and >45 years with endometrial adenocarcinoma in tertiary referral hospital: a 21-year cohort study
Authors: Panyavaranant Pinyada , Rattanachaipipat Juthamas , Manchana Tarinee
Published: January 2025

Objective

This study aimed to compare clinicopathological characteristics and oncological outcomes in patients with endometrial cancer aged ≤45 and >45 years, with a focus on identifying distinct traits and prognostic factors in younger patients.

Design

A retrospective cohort study.

Setting

The study was conducted at King Chulalongkorn Memorial Hospital, Bangkok, Thailand, with a restricted study population from 1996 to 2016.

Participants

A total of 1114 patients diagnosed with endometrial cancer and underwent surgery were strictly selected, excluding those who had received primary radiotherapy or had uterine sarcoma. Among the population, 188 patients (16.9%) were ≤45 years old and 926 patients (83.1%) were >45 years old.

Outcome measures

The primary outcome measures were disease-free survival (DFS) and overall survival (OS) at 5, 10 and 15 years, with an analysis of survival rates based on patient age groups and prognostic factors.

Results

Younger patients (≤45 years) displayed significantly higher rates of obesity, nulliparity and polycystic ovary syndrome (PCOS), as well as favourable pathological characteristics such as well-differentiated tumours and lower rates of myometrial invasion. They also exhibited better long-term survival outcomes, the DFS rates at 5, 10 and 15 years were 89.6% (95% CI: 84.0 to 98.3), 85.9% (95% CI: 79.0 to 90.6) and 76.8% (95% CI: 63.3 to 85.9), respectively, compared with 77.6% (95% CI: 74.6 to 80.2), 69.2% (95% CI: 65.6 to 72.5) and 53.5% (95% CI: 48.0 to 58.6) in the older group. Similarly, the OS rates at 5, 10 and 15 years were 94.7% (95% CI: 90.1 to 97.2), 91.7% (95% CI: 85.4 to 95.3) and 74.0% (95% CI: 51.7 to 87.2), respectively, compared with 86.9% (95% CI: 84.4 to 89.0), 76.6% (95% CI: 73.0 to 79.7) and 60.7% (95% CI: 55.0 to 65.8) in the older group. Independent prognostic factors consist of non-endometrioid histology, involvement of the lower uterine segment and cervix, omental metastasis, lymphovascular invasion and advanced stage.

Conclusions

Young patients with endometrial cancer exhibit distinct favourable clinicopathological characteristics associated with better oncological outcomes compared with older patients. However, certain aggressive disease features should be taken into consideration as they have a negative influence on prognosis significantly. These insights emphasise the need for targeted management strategies and further research.
Postpartum haemorrhage following vaginal delivery: a comprehensive analysis and development of predictive models for aetiological subgroups in Chinese women
Authors: Li Jinke , Zhang Dandan , Lin Hong , Shao Mengyuan , Wang Xiaoxue , Chen Xueting , Zhou Yangzi , Song Zixuan
Published: January 2025

Objectives

This study aimed to dissect the aetiological subgroups of postpartum haemorrhage (PPH) that occur after vaginal delivery in women with full-term singleton pregnancies. Our goal was to craft and validate predictive models to guide clinical decision-making and optimise resource allocation.

Design

A retrospective cohort study.

Setting

Shengjing Hospital of China Medical University, Liaoning Maternal and Child Health Hospital, and Shenyang Women’s and Children’s Hospital.

Participants

29 842 women who underwent vaginal delivery were enrolled in the study across three hospitals from 2016 to 2022.

Primary outcome measures

PPH, categorised into uterine atony (UA), placental factors (PF), cervical trauma (CT), and coagulation abnormalities (CA) by aetiology.

Results

The logistic regression for overall PPH and UA-PPH showcased high discrimination (AUCs of 0.807 and 0.794, respectively), coupled with commendable calibration and DCA-assessed clinical utility, culminating in the development of a nomogram for risk prediction. The PF-PPH model exhibited a modest AUC of 0.739, while the CT-PPH and CA-PPH models demonstrated suboptimal clinical utility and calibration.

Conclusion

The study identified factors associated with PPH and developed models with good performance for overall PPH and UA-PPH. The nomogram offers a valuable tool for risk prediction. However, models for PF-PPH, CT-PPH, and CA-PPH require further refinement. Future research should focus on larger samples and multicentre validation for enhanced model generalisability.