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SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema

Por: Devoogdt · N. · De Vrieze · T. · Heroes · A.-K. · Bechter-Hugl · B. · Fieuws · S. · Godderis · L. · Segers · K. · Maleux · G. · Deltombe · T. · Frippiat · J. · Servaes · M. · Berners · A. · Fosseprez · P. · Krug · B. · Kayser · F. · Falticeanu · A. · Randon · C. · Monten · C. · Van Landuyt
Introduction

Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema.

Methods and analysis

A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient’s own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased.

Ethics and dissemination

The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations.

Trial registration number

NCT05064176

Standard cardiopulmonary resuscitation versus chest compressions only after out-of-hospital cardiac arrest: a protocol for a systematic review and meta-analysis

Por: An · S. · Liu · Y. · Xi · Q. · Zhang · Y. · Gao · Y. · Zhang · W.
Introduction

The 2020 American Heart Association guidelines encourage lay rescuers to provide chest compression-only cardiopulmonary resuscitation to simplify the process and encourage cardiopulmonary resuscitation initiation. However, recent clinical trials had contradictory results about chest compression-only cardiopulmonary resuscitation. This study will aim to compare standard and chest compressions-only cardiopulmonary resuscitation after out-of-hospital cardiac arrest.

Methods and analysis

This study will retrieve only randomised and quasi-randomised controlled trials from the Cochrane Library, PubMed, Web of Science and Embase databases. Data on study design, participant characteristics, intervention details and outcomes will be extracted by a unified standard form. Primary outcomes to be assessed are hospital admission, discharge, and 30-day survival, and return of spontaneous circulation. The Grading of Recommendations, Assessment, Development and Evaluation framework will evaluate the quality of evidence. Cochrane’s tool for assessing the risk of bias will evaluate risk deviation. If the I2 statistic is lower than 40%, the fixed-effects model will be used for meta-analysis. Otherwise, the random-effects model will be used. The search will be performed following the publication of this protocol (estimated to occur on 30 December 2024).

Discussion

This study will evaluate the effect of chest compression-only cardiopulmonary resuscitation after out-of-hospital cardiac arrest and provide evidence for cardiopulmonary resuscitation guidelines.

Ethics and dissemination

No patient or public entity will be involved in this study. Therefore, the study does not need to be ethically reviewed. The results of the study will be disseminated through peer-reviewed journal publications and committee conferences.

PROSPERO registration number

CRD42021295507.

What recovery domains are important following a total knee replacement? A qualitative, interview-based study

Por: Khatri · C. · Dhaif · F. · Ellard · D. · Rodrigues · J. N. · Underwood · M. · Mitchell · P. · Metcalfe · A.
Objectives

To explore people’s views of recovery from total knee replacement (TKR) and which recovery domains they felt were important.

Design

Semi-structured interviews exploring the views of individuals about to undergo or who have undergone TKR. A constant-comparative approach with thematic analysis was used to identify themes. The process of sampling, collecting data and analysis were continuous and iterative throughout the study, with interviews ceasing once thematic saturation was achieved.

Setting

Tertiary care centre.

Participants

A purposive sample was used to account for variables including pre, early or late postoperative status.

Results

12 participants were interviewed, 4 who were preoperative, 4 early postoperative and 4 late postoperative. Themes of pain, function, fear of complications, awareness of the artificial knee joint and return to work were identified. Subthemes of balancing acute and chronic pain were identified.

Conclusions

The results of this interview-based study identify pain and function, in particular mobility, that were universally important to those undergoing TKR. Surgeons should consider exploring these domains when taking informed consent to enhance shared decision-making. Researchers should consider these recovery domains when designing interventional studies.

Effectiveness and cost-effectiveness of community-based directly observed treatment (DOT) versus health facility-based DOT of tuberculosis in Africa: protocol for a systematic review and meta-analysis

Por: Baye · T. · Kassaw · A. T. · Gebrie · D. · Girmaw · F. · Ashagrie · G.
Background

Tuberculosis (TB) remains a significant global health challenge, especially prevalent in the WHO African region. The WHO’s End TB Strategy emphasises effective treatment approaches such as directly observed therapy (DOT), yet the optimal implementation of DOT, whether through health facility-based (HF DOT) or community-based (CB DOT) approaches, remains uncertain.

Objective

To conduct a systematic comparison of the effectiveness and cost-effectiveness of Community-Based Directly Observed Treatment (CB DOT) versus Health Facility-Based Directly Observed Treatment (HF DOT) for tuberculosis (TB) treatment in African settings.

Methods

We will conduct a systematic review and meta-analysis following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search PubMed, Embase, Web of Science, Scopus and the Cochrane Library for articles published up to 30 March 2023, without date restrictions. Eligible studies must be full economic evaluations conducted in African countries, comparing CB DOT to HF DOT regarding treatment outcomes and costs. Exclusion criteria include non-English, non-peer-reviewed or studies lacking caregiver involvement in CB DOT, health facility-based DOT comparison, direct comparability between CB DOT and HF DOT, significant selection bias or non-economic evaluations. Data extraction will be performed independently by reviewers, and meta-analyses will use STATA software. To pool the data, a random-effect model will be applied, and quality assessment of the studies will be conducted.

Ethics and dissemination

Ethical approval is not required as the study will use previously published articles available publicly. Findings will be presented at international and national conferences and published in open-access, peer-reviewed journals.

PROSPERO registration number

CRD42023443260.

Understanding associations between the COVID-19 pandemic and menstrual hygiene management among adolescent girls in Ethiopia: findings from a mixed-methods longitudinal study

Por: Murphy · M. · Dutton · R. · Gezahegne · K. · Jones · N. · Seager · J. · Baird · S.
Objective

To understand the relationship between the COVID-19 pandemic and menstrual hygiene management (MHM) among adolescent girls in Ethiopia and to explore which girls were most affected by pandemic disruptions.

Design

Two rounds of data from surveys and interviews were collected with adolescent girls immediately prior to and during the COVID-19 pandemic. The primary analysis is cross-sectional, controlling for pre-COVID-19 covariates.

Setting

The setting was three zones in two regions of Ethiopia: East Hararghe and East Shewa Zones in Oromia and South Gondar Zone in Amhara. Data were collected in December 2019–March 2020 and September 2020–February 2021.

Participants

742 adolescent girls, ages 11–25 years.

Outcome measures

Four primary outcomes were explored (1) the number of challenges girls experienced; (2) adolescent-identified challenges managing menstrual hygiene; (3) adolescent-identified difficulties accessing MHM products and (4) adolescent-identified difficulties accessing soap or water.

Results

Girls who were more vulnerable to COVID-19 were more likely to have worse MHM outcomes. An SD increase in household vulnerability to COVID-19 was associated with an 8.7 percentage point increase in the likelihood that the respondent had difficulty getting MHM products (p

Conclusions

The results of this study suggest that MHM was left behind in the COVID-19 response. New programming and policy interventions need to address financial hardship and disruptions to supplies to manage menstruation as well as tackle the inequitable gender norms that stigmatise menstruation during emergencies.

Interventions to promote medical student well-being: an overview of systematic reviews

Por: Bennett-Weston · A. · Keshtkar · L. · Jones · M. · Sanders · C. · Lewis · C. · Nockels · K. · Solomon · J. · Howick · J.
Objective

To conduct an overview of systematic reviews that explore the effectiveness of interventions to enhance medical student well-being.

Design

Overview of systematic reviews.

Data sources

The Cochrane Library of Systematic Reviews, MEDLINE, APA PsychInfo, CINAHL and Scopus were searched from database inception until 31 May 2023 to identify systematic reviews of interventions to enhance medical student well-being. Ancestry searching and citation chasing were also conducted.

Data extraction and synthesis

The Assessing the Methodological Quality of Systematic Reviews V.2 tool was used to appraise the quality of the included reviews. A narrative synthesis was conducted, and the evidence of effectiveness for each intervention was rated.

Results

13 reviews (with 94 independent studies and 17 616 students) were included. The reviews covered individual-level and curriculum-level interventions. Individual interventions included mindfulness (n=12), hypnosis (n=6), mental health programmes (n=7), yoga (n=4), cognitive and behavioural interventions (n=1), mind-sound technology (n=1), music-based interventions (n=1), omega-3 supplementation (n=1), electroacupuncture (n=1) and osteopathic manipulative treatment (n=1). The curriculum-level interventions included pass/fail grading (n=4), problem-based curriculum (n=2) and multicomponent curriculum reform (n=2). Most interventions were not supported by sufficient evidence to establish effectiveness. Eleven reviews were rated as having ‘critically low’ quality, and two reviews were rated as having ‘low’ quality.

Conclusions

Individual-level interventions (mindfulness and mental health programmes) and curriculum-level interventions (pass/fail grading) can improve medical student well-being. These conclusions should be tempered by the low quality of the evidence. Further high-quality research is required to explore additional effective interventions to enhance medical student well-being and the most efficient ways to implement and combine these for maximum benefit.

Helping patients prepare their dependent children for parental death: mixed-methods evaluation of a codeveloped training programme for palliative and allied healthcare professionals in the UK

Por: Cockle-Hearne · J. · Groothuizen · J. E. · Ream · E.
Objectives

To evaluate how the codesigned training programme, ‘No conversation too tough’, can help cancer, palliative and wider healthcare professionals support patients to communicate with their dependent children when a parent is dying. We examined perceptions of learning provided by the training, its contribution to confidence in communicating with families when a parent is dying, and subjective experience of, and reactions to, the training. We also explored potential changes in practice behaviours.

Design

Pre–post, convergent, parallel, mixed-methods study. Motivations for practice change were measured quantitatively, and qualitatively through semi-structured interviews. Non-parametric analysis was conducted for self-efficacy and outcome expectancy measures; descriptive statistics examined perceptions of usefulness; intentions to use learning in practice and reactions to the training. Semi-structured interviews examined motivations and perceptions of learning in depth. A 6-week, practice log recorded immediate practice effects and reflections.

Setting

1-day training delivered 3 times, total delegates 36: online December 2021, February 2022, face-to-face March 2022. Questionnaires delivered correspondingly in online or paper formats, semi-structured interviews online.

Participants

Pre–post: palliative care professionals (n=14/12), acute cancer clinical nurse specialists (n=16/11), other healthcare professionals (n=5/5).

Results

Positive changes were observed in self-efficacy (17 of 19 dimensions p

Conclusions

The training programme has the potential to effect change in practice behaviours. A large-scale study will evaluate the roll-out of the training delivered to individual professionals and whole teams across the UK. It will provide longer-term feedback to understand practice behaviour and mediators of change across professional roles.

'Its just my knee: a qualitative study investigating the process of reframing and young athletes perceived quality of life between anterior cruciate ligament injury and surgery

Por: Marmura · H. · Bryant · D. · Getgood · A. · Webster · F.
Objectives

To understand the factors influencing young athletes’ perceptions of quality of life (QOL) following an anterior cruciate ligament (ACL) rupture, prior to reconstructive surgery.

Design

Qualitative descriptive study using semi-structured interviews and thematic analysis of data.

Setting

Tertiary sports medicine clinic with patients recruited from the practices of three specialist orthopaedic surgeons.

Participants

Twenty athletes aged 14–25 provided consent to participate in the study and completed interviews prior to their ACL reconstruction surgery. Participants were eligible to participate if they were scheduled to undergo ACL reconstruction, were 25 years of age or younger, identified as athletes (participated in any level of organised sport), could communicate in English and agreed to be audio recorded. Participants were not eligible if they had experienced a multiligament injury or fracture.

Results

Young athletes shared common factors that made up their QOL; social connections and support, sport, health, and independence. However, participants’ perceptions of their current QOL were quite variable (13–95/100 on a Visual Analogue Scale). Participants who were able to reframe their injury experience by shifting focus to the positive or unaffected aspects of their lives tended to have more favourable perceptions of their QOL than participants who shifted focus to the losses associated with injury.

Conclusions

Young athletes who have experienced an ACL injury define their QOL based on social support, sport, health and independence. Individual processes of adaptation and cognitive reframing in response to an ACL injury may exert a greater influence on postinjury QOL than the physical ramifications of the injury itself. Understanding individual perceptions may help target potential interventions or supports to enhance athletes’ adaptation to injury.

Assessing the mediating role of family resilience between caregiver burden and caregiver capacity: a cross-sectional study among Chinese stroke survivors and family caregivers in a real-world setting

Por: Xu · Q. · Ge · Q. · Shi · L. · Zhang · Y. · Ma · J.
Objectives

To investigate the relationships among caregiver burden, family resilience, and caregiver capacity in the care of stroke survivors. We hypothesised that family resilience would mediate the relationship between caregiver burden and caregiver capacity.

Design

A cross-sectional study design was used.

Setting

The study was conducted in a tertiary care setting in Ningbo City, Zhejiang Province, China.

Participants

The study involved 413 stroke survivors and their primary caregivers.

Outcome measures

The primary caregivers completed the Shortened Chinese Version of the Family Resilience Assessment Scale, Zarit Caregiver Burden Interview and Family Caregiver Task Inventor and provided their sociodemographic information. Stroke survivors were assessed for activities of daily living, and their sociodemographic information was provided. Data were analysed, controlling for sociodemographic variables and focusing on the mediating effect of family resilience.

Results

Caregiver burden was influenced by the activities of daily living of stroke survivors, caregiver age and caregiver health status (p

Conclusions

Enhancing family resilience can reduce caregiver burden and improve caregiver capacity in stroke care. These findings underscore the importance of developing interventions focused on nursing skills and family resilience.

Pulsed field ablation with the pentaspline catheter compared with cryoablation for the treatment of paroxysmal atrial fibrillation in the UK NHS: a cost-comparison analysis

Por: Duxbury · C. · Begley · D. · Heck · P. M.
Objectives

Pulsed field ablation (PFA) is a promising new ablation modality for the treatment of atrial fibrillation (AF) that has recently become available in the UK National Health Service (NHS). We provide the first known economic evaluation of the technology.

Methods

A cost-comparison model was developed to compare the expected 12-month costs of treating AF using the pentaspline PFA catheter compared with cryoablation for a single hypothetical patient. Model parameters were based on a recent cost-effectiveness analysis by the National Institute for Health and Care Excellence where possible or published literature otherwise. Deterministic sensitivity, scenario and threshold analyses were conducted.

Results

Costs for a single patient treated with PFA were –3% (–£343) less over 12 months than those who received treatment with cryoablation. PFA was associated with 16% higher catheter costs but repeat ablation costs were over 50% less, driven by a reduction in repeat ablations required. Costs of managing complications were –£211 less in total for PFA compared with cryoablation.

Conclusions

Routine adoption of PFA with the pentaspline PFA catheter looks to be as affordable for the NHS as current treatment alternative cryoablation.

Perfusion outcomes with near-infrared indocyanine green imaging system in laparoscopic total mesorectal excision for mid-rectal or low-rectal cancer (POSTER): a study protocol

Por: Sun · L. · Gao · J. · Wu · G. · Meng · C. · Yang · Z. · Wei · P. · Yao · H. · Zhang · Z.
Introduction

Anastomotic leakage (AL) is defined as the failure of complete healing or disruption of the anastomosis subsequent to rectal cancer surgery, resulting in the extravasation of intestinal contents into the intra-abdominal or pelvic cavity. It is a serious complication of rectal cancer surgery, accounting for a considerable increase in morbidity and mortality. The use of fluorescence imaging technology in surgery allows surgeons to better evaluate blood perfusion. However, the conclusions of some existing studies are not consistent, so a consensus on whether the near-infrared indocyanine green (NIR–ICG) imaging system can reduce the incidence of AL is needed.

Methods

This POSTER trial is designed as a multicentre, prospective, randomised controlled clinical study adhering to the "population, interventions, comparisons, outcomes (PICO)" principles. It is scheduled to take place from August 2019 to December 2024 across eight esteemed hospitals in China. The target population consists of patients diagnosed with rectal cancer through pathological confirmation, with tumours located≤10 cm from the anal verge, eligible for laparoscopic surgery. Enrolled patients will be randomly assigned to either the intervention group or the control group. The intervention group will receive intravenous injections of ICG twice, with intraoperative assessment of anastomotic blood flow using the near-infrared NIR–ICG system during total mesorectal excision (TME) surgery. Conversely, the control group will undergo conventional TME surgery without the use of the NIR-ICG system. A 30-day follow-up period postoperation will be conducted to monitor and evaluate occurrences of AL. The primary endpoint of this study is the incidence of AL within 30 days postsurgery in both groups. The primary outcome investigators will be blinded to the application of ICG angiography. Based on prior literature, we hypothesise an AL rate of 10.3% in the control group and 3% in the experimental group for this study. With a planned ratio of 2:1 between the number of cases in the experimental and control groups, and an expected 20% lost-to-follow-up rate, the initial estimated sample size for this study is 712, comprising 474 in the experimental group and 238 in the control group.

Ethics and dissemination

This study has been approved by Ethics committee of Beijing Friendship Hospital, Capital Medical University (approval number: 2019-P2-055-02). The results will be disseminated in major international conferences and peer-reviewed journals.

Trial registration number

NCT04012645.

Six aspects of female genital mutilation education (SAFE) model: findings from a qualitative study

Por: Waigwa · S. · Bradbury-Jones · C. · Doos · L. · Taylor · J.
Objectives

Recent figures show that over 200 million women and girls, globally, live with the consequences of female genital mutilation (FGM). Complex debilitating physical, psychological and social problems result from the practice. Health education interventions have proven to be essential in both preventing the practice and informing support of survivors. In this study, we aimed to explore factors that affect the effectiveness of health education interventions.

Design

A generic qualitative approach was applied using semistructured individual and focus group interviews with women and men from communities with a history of FGM in Birmingham, UK. Framework analysis was used to group recurring themes from the data. Intersectionality was used as a theoretical lens to synthesise findings.

Participants

Twenty-one individuals (18 women and 3 men) participated in semistructured individual and focus group interviews about their views and experiences of health and well-being intervention programmes related to FGM.

Results

Six themes emerged from the data and were developed into a model of issues relating to FGM education. These six themes are (1) active communication, (2) attitudes and beliefs, (3) knowledge about FGM, (4) social structures, (5) programme approach and (6) the better future. A combined discussion of all these issues was compressed into three groupings: social structures, culture and media.

Conclusion

The results of this study depict aspects associated with FGM education that should be considered by future interventions aiming to prevent the practice and inform support services for survivors in a holistic way.

Did COVID-19 ICU patient mortality risk increase as Colorado hospitals filled? A retrospective cohort study

Por: Johnson · D. R. · Ghosh · D. · Wagner · B. D. · Carlton · E. J.
Objectives

To assess whether increasing levels of hospital stress—measured by intensive care unit (ICU) bed occupancy (primary), ventilators in use and emergency department (ED) overflow—were associated with decreasing COVID-19 ICU patient survival in Colorado ICUs during the pre-Delta, Delta and Omicron variant eras.

Design

A retrospective cohort study using discrete-time survival models, fit with generalised estimating equations.

Setting

34 hospital systems in Colorado, USA, with the highest patient volume ICUs during the COVID-19 pandemic.

Participants

9196 non-paediatric SARS-CoV-2 patients in Colorado hospitals admitted once to an ICU between 1 August 2020 and 1 March 2022 and followed for 28 days.

Outcome measures

Death or discharge to hospice.

Results

For Delta-era COVID-19 ICU patients in Colorado, the odds of death were estimated to be 26% greater for patients exposed every day of their ICU admission to a facility experiencing its all-era 75th percentile ICU fullness or above, versus patients exposed for none of their days (OR: 1.26; 95% CI: 1.04 to 1.54; p=0.0102), adjusting for age, sex, length of ICU stay, vaccination status and hospital quality rating. For both Delta-era and Omicron-era patients, we also detected significantly increased mortality hazard associated with high ventilator utilisation rates and (in a subset of facilities) states of ED overflow. For pre-Delta-era patients, we estimated relatively null or even protective effects for the same fullness exposures, something which provides a meaningful contrast to previous studies that found increased hazards but were limited to pre-Delta study windows.

Conclusions

Overall, and especially during the Delta era (when most Colorado facilities were at their fullest), increasing exposure to a fuller hospital was associated with an increasing mortality hazard for COVID-19 ICU patients.

Cognitive stimulation for people with dementia in nursing homes: a protocol for a feasibility study examining a new 24/7 approach (CogStim24)

Por: Folkerts · A.-K. · Seven · U. S. · Guicheteau · J. · N Dichter · M. · Hellmich · M. · Köpke · S. · Kalbe · E.
Introduction

Based on the available evidence, cognitive stimulation is recommended as an intervention for people with dementia (PwD). Currently, cognitive stimulation is regularly offered as a group programme in care facilities. However, some residents, such as those who are bedridden, cannot participate. Furthermore, group programmes were not feasible during the pandemic. A concept that accompanies everyday life and enables cognitive stimulation in everyday communication (ie, ‘24/7’) has been missing. Therefore, this feasibility study aims to (1) assess the feasibility of a new continuous 24/7 cognitive stimulation programme (CogStim24) based on a process evaluation and (2) examine the possible effects of CogStim24 on the primary outcome of global cognition in PwD and further PwD-related and staff-related outcomes.

Methods and analysis

The complex CogStim24 programme is developed to be conducted as an everyday intervention during routine care including cognitively stimulating techniques, such as reminiscence therapy, multisensory stimulation and physical activity. In this unblinded single-arm study with pre-assessments and post-assessments, four nursing homes with a total of N=20 nursing and care staff will participate in an 11-week CogStim24 training programme. The intervention will be conducted to N=60 PwD. Neuropsychological assessments will be conducted pre-staff and post-staff training, as well as after a 6-week implementation phase. A process evaluation will be performed.

Ethics and dissemination

Ethics approval was obtained from the ethics committee of the Faculty of Medicine of the University of Cologne, Cologne, Germany. Although cognitive stimulation is known to be effective for enhancing global cognition and quality of life in PwD, it is currently undersupplied to PwD. Therefore, CogStim24 has the potential to reach many more PwD. This study has the potential to serve as a basis for a large multicentre cluster randomised controlled trial. An interdisciplinarity team and mixed-methods approach will help generate information on the practicality and mechanisms of impact of CogStim24. This is important for the further development of the intervention and for facilitating its implementation. The study results will be disseminated via presentations at scientific conferences and meetings for healthcare professionals and PwD and their relatives. Several manuscripts presenting results of the different study parts will be published in peer-reviewed journals.

Trial registration number

DRKS00024381.

Evaluation of adherence to pharmacological treatments by undocumented migrants with chronic diseases: a 10-year retrospective cohort study

Por: Fiorini · G. · Pellegrini · G. · Franchi · M. · Rigamonti · A. E. · Marazzi · N. · Sartorio · A. · Corrao · G. · Cella · S. G.
Objectives

To investigate the time course of medication adherence and some of the factors involved in this process in undocumented migrants with chronic diseases.

Design

Retrospective cohort study.

Setting

A big non-governmental organisation in Milano, Italy, giving medical assistance to undocumented migrants.

Participants

1918 patients, 998 females and 920 males, with at least one chronic condition (diabetes, cardiovascular diseases (CVDs), mental health disorders) seen over a period of 10 years (2011–2020). Their mean age was 49.2±13 years.

Results

Adherence to medications decreased over 1 year in all patients. This was more evident during the first 2 months of treatment. Patients on only one medication were less adherent than those on more than one medication; at 6 months the percentage of patients with high adherence was 33% vs 57% (p

Conclusions

Interventions to increase medication adherence of undocumented migrants with chronic diseases are necessary, particularly in the first 2 months after beginning treatment. These should be aimed at people-centred care and include more outpatient consultations. Educational interventions should especially be taken into consideration for patients on monotherapy.

Medical researchers perceptions regarding research evaluation: a web-based survey in Japan

Por: Minoura · A. · Shimada · Y. · Kuwahara · K. · Kondo · M. · Fukushima · H. · Sugiyama · T.
Objectives

Japanese medical academia continues to depend on quantitative indicators, contrary to the general trend in research evaluation. To understand this situation better and facilitate discussion, this study aimed to examine how Japanese medical researchers perceive quantitative indicators and qualitative factors of research evaluation and their differences by the researchers’ characteristics.

Design

We employed a web-based cross-sectional survey and distributed the self-administered questionnaire to academic society members via the Japanese Association of Medical Sciences.

Participants

We received 3139 valid responses representing Japanese medical researchers in any medical research field (basic, clinical and social medicine).

Outcomes

The subjective importance of quantitative indicators and qualitative factors in evaluating researchers (eg, the journal impact factor (IF) or the originality of the research topic) was assessed on a four-point scale, with 1 indicating ‘especially important’ and 4 indicating ‘not important’. The attitude towards various opinions in quantitative and qualitative research evaluation (eg, the possibility of research misconduct or susceptibility to unconscious bias) was also evaluated on a four-point scale, ranging from 1, ‘strongly agree’, to 4, ‘completely disagree’.

Results

Notably, 67.4% of the medical researchers, particularly men, younger and basic medicine researchers, responded that the journal IF was important in researcher evaluation. Most researchers (88.8%) agreed that some important studies do not get properly evaluated in research evaluation using quantitative indicators. The respondents perceived quantitative indicators as possibly leading to misconduct, especially in basic medicine (strongly agree—basic, 22.7%; clinical, 11.7%; and social, 16.1%). According to the research fields, researchers consider different qualitative factors, such as the originality of the research topic (especially important—basic, 46.2%; social, 39.1%; and clinical, 32.0%) and the contribution to solving clinical and social problems (especially important—basic, 30.4%; clinical, 41.0%; and social, 52.0%), as important. Older researchers tended to believe that qualitative research evaluation was unaffected by unconscious bias.

Conclusion

Despite recommendations from the Declaration on Research Assessment and the Leiden Manifesto to de-emphasise quantitative indicators, this study found that Japanese medical researchers have actually tended to prioritise the journal IF and other quantitative indicators based on English-language publications in their research evaluation. Therefore, constantly reviewing the research evaluation methods while respecting the viewpoints of researchers from different research fields, generations and genders is crucial.

Association between indoor air pollution and depression: a systematic review and meta-analysis of cohort studies

Por: Zhang · X. · Ding · L. · Yang · F. · Qiao · G. · Gao · X. · Xiong · Z. · Zhu · X.
Objectives

Incomplete combustion of solid fuel and exposure to secondhand smoke (SHS) are the primary causes of indoor air pollution (IAP), potentially leading to detrimental effects on individual mental health. However, current evidence regarding the association between IAP and depression remains inconclusive. This study aims to systematically investigate the evidence regarding the association between IAP and the risk of depression.

Design

Systematic review and meta-analysis of cohort studies.

Data sources

Two independent reviewers searched PubMed, the Cochrane Library, Web of Science and EMBASE for available studies published up to 13 January 2024.

Eligibility criteria

We included all cohort studies published in English that aimed to explore the relationship between IAP from solid fuel use and SHS exposure and the risk of depression.

Data extraction and synthesis

Two independent reviewers extracted data and assessed the risk of bias. The association between IAP and depression was calculated using pooled relative risk (RR) with 95% CIs. Heterogeneity was assessed using the I2 value, and the effect estimates were pooled using fixed-effects or random-effects models depending on the results of homogeneity analysis.

Results

We included 12 articles with data from 61 217 participants. The overall findings demonstrated a significant association between IAP exposure and depression (RR=1.22, 95% CI: 1.13 to 1.31), although with substantial heterogeneity (I2=75%). Subgroup analyses based on pollutant type revealed that IAP from solid fuel use was associated with a higher risk of depression (RR=1.20, 95% CI: 1.13 to 1.26; I2=62%; 5 studies, 36 768 participants) than that from SHS exposure (RR=1.11, 95% CI: 0.87 to 1.41; I2=80%; 7 studies, 24 449 participants). In terms of fuel use, the use of solid fuel for cooking (RR: 1.23, 95% CI: 1.16 to 1.31; I2=58%; 4 studies, 34 044 participants) and heating (RR 1.15, 95% CI: 1.04 to 1.27; I2=65%; 3 studies, 24 874 participants) was associated with increased depression risk.

Conclusions

The findings from this systematic review and meta-analysis of cohort studies indicated an association between exposure to IAP and depression.

PROSPERO registration number

CRD42022383285.

Relationship between self-psychological adjustment and post-traumatic growth in patients with lung cancer undergoing chemotherapy: a cross-sectional study

Por: Liu · N. · Zhang · L. · Liu · Y. · Ding · X. · Li · Q. · Lixia · G. · Zhang · X.
Objectives

This study aimed to determine the potential profiles of self-psychological adjustment in patients with lung cancer undergoing chemotherapy, including sense of coherence (SOC) and positive cognitive emotion regulation (PCER). The relationship between these profiles with post-traumatic growth (PTG) and the relevant factors of self-psychological adjustment in different profiles was analysed.

Design

Cross-sectional study.

Setting

Patients with lung cancer undergoing chemotherapy in China.

Participants

A total of 330 patients with lung cancer undergoing chemotherapy were recruited out of which 321 completed the questionnaires effectively.

Methods

Latent profile analysis was used to identify self-psychological adjustment classes based on the two subscales of the Sense of Coherence Scale and Cognitive Emotion Regulation Questionnaire. One-way analysis of variance and multinomial logistic regression were performed to examine the subgroup association with characteristics and PTG.

Results

Three latent profiles of self-psychological adjustment were identified: low level (54.5%), high SOC-low PCER (15.6%) and high PCER (29.9%). The results of univariate analysis showed a significant difference in PTG scores among different self-psychological adjustment subgroups (F=11.55, p

Conclusion

This study revealed that most patients with lung cancer undergoing chemotherapy belonged to the low-level group. Three profiles are associated with PTG. There were differences in characteristics between patients treated with chemotherapy for lung cancer in the high-PCER and low-PCER groups. Thus, these profiles provide useful information for developing targeted individualised interventions based on demographic characteristics that would assist PTG in patients with lung cancer undergoing chemotherapy.

Use of artificial intelligence in obstetric and gynaecological diagnostics: a protocol for a systematic review and meta-analysis

Por: Chaurasia · A. · Curry · G. · Zhao · Y. · Dawoodbhoy · F. · Green · J. · Vaninetti · M. · Shah · N. · Greer · O.
Introduction

Emerging developments in applications of artificial intelligence (AI) in healthcare offer the opportunity to improve diagnostic capabilities in obstetrics and gynaecology (O&G), ensuring early detection of pathology, optimal management and improving survival. Consensus on a robust AI healthcare framework is crucial for standardising protocols that promote data privacy and transparency, minimise bias, and ensure patient safety. Here, we describe the study protocol for a systematic review and meta-analysis to evaluate current applications of AI in O&G diagnostics with consideration of reporting standards used and their ethical implications. This protocol is written following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 checklist.

Methods and analysis

The study objective is to explore the current application of AI in O&G diagnostics and assess the reporting standards used in these studies. Electronic bibliographic databases MEDLINE, EMBASE and Cochrane will be searched. Study selection, data extraction and subsequent narrative synthesis and meta-analyses will be carried out following the PRISMA-P guidelines. Included papers will be English-language full-text articles from May 2015 to March 2024, which provide original data, as AI has been redefined in recent literature. Papers must use AI as the predictive method, focusing on improving O&G diagnostic outcomes.

We will evaluate the reporting standards including the risk of bias, lack of transparency and consider the ethical implications and potential harm to patients. Outcome measures will involve assessing the included studies against gold-standard criteria for robustness of model development (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis, model predictive performance, model risk of bias and applicability (Prediction model Risk Of Bias Assessment Tool and study reporting (Consolidated Standards of Reporting Trials-AI) guidance.

Ethics and dissemination

Ethical approval is not required for this systematic review. Findings will be shared through peer-reviewed publications.There will be no patient or public involvement in this study.

PROSPERO registration number

CRD42022357024.

Cohort profile: the Environmental Reproductive and Glucose Outcomes (ERGO) Study (Boston, Massachusetts, USA) -- a prospective pregnancy cohort study of the impacts of environmental exposures on parental cardiometabolic health

Por: Preston · E. V. · Quinn · M. R. · Williams · P. L. · McElrath · T. F. · Cantonwine · D. E. · Seely · E. W. · Wylie · B. J. · Hacker · M. R. · O'Brien · K. · Brown · F. M. · Powe · C. E. · Bellavia · A. · Wang · Z. · Tomsho · K. S. · Hauser · R. · James-Todd · T. · the Environmental Rep
Purpose

Pregnancy and the postpartum period are increasingly recognised as sensitive windows for cardiometabolic disease risk. Growing evidence suggests environmental exposures, including endocrine-disrupting chemicals (EDCs), are associated with an increased risk of pregnancy complications that are associated with long-term cardiometabolic risk. However, the impact of perinatal EDC exposure on subsequent cardiometabolic risk post-pregnancy is less understood. The Environmental Reproductive and Glucose Outcomes (ERGO) Study was established to investigate the associations of environmental exposures during the perinatal period with post-pregnancy parental cardiometabolic health.

Participants

Pregnant individuals aged ≥18 years without pre-existing diabetes were recruited at

Findings to date

We enrolled 653 unique pregnancies and retained 633 through delivery. Participants had a mean age of 33 years, 10% (n=61) developed gestational diabetes and 8% (n=50) developed pre-eclampsia. Participant pregnancy and postpartum urinary phthalate metabolite concentrations and postpartum glycaemic biomarkers were quantified. To date, studies within ERGO found higher exposure to phthalates and phthalate mixtures, and separately, higher exposure to radioactive ambient particulate matter, were associated with adverse gestational glycaemic outcomes. Additionally, certain personal care products used in pregnancy, notably hair oils, were associated with higher urinary phthalate metabolite concentrations, earlier gestational age at delivery and lower birth weight.

Future plans

Future work will leverage the longitudinal data collected on pregnancy and cardiometabolic outcomes, environmental exposures, questionnaires, banked biospecimens and paediatric data within the ERGO Study.

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