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Impact evaluation of a cash-plus programme for children with disabilities in the Xiengkhouang Province in Lao PDR: study protocol for a non-randomised controlled trial

Por: Banks · L. M. · Soukkhaphone · B. · Scherer · N. · Siengsounthone · L. · Carew · M. T. · Shakespeare · T. · Chen · S. · Davey · C. · Goyal · D. · Zinke-Allmang · A. · Kuper · H. · Chanthakoumane · K.
Introduction

More than 170 countries have implemented disability-targeted social protection programmes, although few have been rigorously evaluated. Consequently, a non-randomised controlled trial is being conducted of a pilot ‘cash-plus’ programme implemented by UNICEF Laos and the Laos government for children with disabilities in the Xiengkhouang Province in Laos. The intervention combines a regular cash transfer with provision of assistive devices and access for caregivers to a family support programme.

Methods and analysis

The non-randomised controlled trial will involve 350 children with disabilities across 3 districts identified by programme implementers as eligible for the programme (intervention arm). Implementers have also identified approximately 180 children with disabilities in neighbouring districts, who would otherwise meet eligibility criteria but do not live in the project areas (control arm). The trial will assess the impact of the programme on child well-being (primary outcome), as well as household poverty, caregiver quality of life and time use (secondary outcomes). Baseline data are being collected May–October 2023, with endline 24 months later. Analysis will be intention to treat. A complementary process evaluation will explore the implementation, acceptability of the programme, challenges and enablers to its delivery and mechanisms of impact.

Ethics and dissemination

The study has received ethical approval from the London School of Hygiene and Tropical Medicine and the National Ethics Committee for Health Research in Laos. Informed consent and assent will be taken by trained data collectors. Data will be collected and stored on a secure, encrypted server and its use will follow a detailed data management plan. Findings will be disseminated in academic journals and in short briefs for policy and programmatic actors, and in online and in-person events.

Trial registration number

ISRCTN80603476.

Association between septic shock and tracheal injury score in intensive care unit patients with invasive ventilation: a prospective single-centre cohort study in China

Por: Zhang · P. · Yang · Q. · Yin · C. · Cai · Z. · Lu · H. · Li · H. · Li · L. · Tian · Y. · Bai · L. · Huang · L.
Objectives

There was no evidence regarding the relationship between septic shock and tracheal injury scores. Investigate whether septic shock was independently associated with tracheal injury scores in intensive care unit (ICU) patients with invasive ventilation.

Design

Prospective observational cohort study.

Setting

Our study was conducted in a Class III hospital in Hebei province, China.

Participants

Patients over 18 years of age admitted to the ICU between 31 May 2020 and 3 May 2022 with a tracheal tube and expected to be on the tube for more than 24 hours.

Primary and secondary outcome measures

Tracheal injuries were evaluated by examining hyperaemia, ischaemia, ulcers and tracheal perforation by fiberoptic bronchoscope. Depending on the number of lesions, the lesions were further classified as moderate, severe or confluent.

Results

Among the 97 selected participants, the average age was 56.6±16.5 years, with approximately 64.9% being men. The results of adjusted linear regression showed that septic shock was associated with tracheal injury scores (β: 2.99; 95% CI 0.70 to 5.29). Subgroup analysis revealed a stronger association with a duration of intubation ≥8 days (p=0.013).

Conclusion

Patients with septic shock exhibit significantly higher tracheal injury scores compared with those without septic shock, suggesting that septic shock may serve as an independent risk factor for tracheal injury.

Trial registration number

ChiCTR2000037842, registered 03 September 2020. Retrospectively registered, https://www.chictr.org.cn/edit.aspx?pid=57011&htm=4.

Paediatric off-label use of drugs in Gansu, China: a multicentre cross-sectional study

Por: Meng · M. · Ge · B. · Lei · W. · Wu · Y. · Tian · M. · Lu · Y. · Shao · T. · Yang · Y. · Luo · X. · Luo · J. · Gao · Y. · Li · Q. · Chen · Y.
Objective

To examine the current prevalence and cost of paediatric off-label drug prescriptions in Gansu, China, and the potential influencing factors.

Design

The prevalence of off-label prescriptions in paediatrics was evaluated according to the National Medical Products Administration drug instructions in the China Pharmaceutical Reference (China Pharmaceutical Reference, MCDEX) database. The evidence of the prescription was determined by existing clinical practice guidelines and the Thomson Grade in the Micromedex 2021 compendium. We used logistic regression to investigate the characteristics that influence paediatric off-label drug use after single-factor regression analysis.

Setting

A multicentre cross-sectional study of outpatient paediatric prescriptions in 196 secondary and tertiary hospitals in Gansu Province, China, in March and September 2020.

Results

We retrieved 104 029 paediatric prescriptions, of which 39 480 (38.0%) contained off-label use. The most common diseases treated by off-label drugs were respiratory system diseases (n=15 831, 40.1%). A quarter of off-label prescriptions had adequate evidence basis (n=10 130, 25.6%). Unapproved indications were the most common type of off-label drug use (n=25 891, 65.6%). A total of 1177 different drugs were prescribed off-label, with multienzyme tablets being the most common drug (n=1790, 3.5%). The total cost of the prescribed off-label drugs was ¥106 116/day. Off-label prescriptions were less frequent in tertiary than in secondary hospitals. Topical preparations were more commonly prescribed off-label than other types of drugs. Senior-level clinicians prescribed drugs off-label more often than intermediate and junior clinicians.

Conclusion

Off-label drug use is widespread in paediatric practice in China. Three-quarters of the prescriptions may potentially include inappropriate medication use, resulting in a daily economic burden of about ¥81 000 in 2020 in Gansu Province with 25 million inhabitants. The management of off-label drug use in paediatrics in China needs improvement.

Exploring opportunities to strengthen rural tuberculosis health service delivery: a qualitative study with health workers in Tibet autonomous region, China

Por: Haldane · V. · Zhang · Z. · Yin · T. · Zhang · B. · Li · Y. · Pan · Q. · Dainty · K. N. · Rea · E. · Pasang · P. · Hu · J. · Wei · X.
Objectives

This qualitative study aimed to explore opportunities to strengthen tuberculosis (TB) health service delivery from the perspectives of health workers providing TB care in Shigatse prefecture of Tibet Autonomous Region, China.

Design

Qualitative research, semi-structured in-depth interviews.

Setting

The TB care ecosystem in Shigatse, including primary and community care.

Participants

Participants: 37 semi-structured interviews were conducted with village doctors (14), township doctors and nurses (14), county hospital doctors (7) and Shigatse Centre for Disease Control staff (2).

Results

The three main themes reported include (1) the importance of training primary and community health workers to identify people with symptoms of TB, ensure TB is diagnosed and link people with TB to further care; (2) the need to engage community health workers to ensure retention in care and adherence to TB medications; and (3) the opportunity for innovative technologies to support coordinated care, retention in care and adherence to medication in Shigatse.

Conclusions

The quality of TB care could be improved across the care cascade in Tibet and other high-burden, remote settings by strengthening primary care through ongoing training, greater support and inclusion of community health workers and by leveraging technology to create a circle of care. Future formative and implementation research should include the perspectives of health workers at all levels to improve care organisation and delivery.

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.

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.

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.

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.

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.

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Por: Marshall · H. · Ward · J. · Wang · B. · Andraweera · P. · McMillan · M. · Flood · L. · Bell · C. · Sisnowski · J. · Krause · V. · Webby · R. · Childs · E. · Gunathilake · M. · Egoroff · N. · Leong · L. · Lawrence · A. · Baird · R. · Freeman · K. · Menouhos · D. · Whiley · D. M. · Karnon · J.
Introduction

The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

Methods and analyses

This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4–7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

Ethics and dissemination

The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

Strategies for optimising early detection and obstetric first response management of postpartum haemorrhage at caesarean birth: a modified Delphi-based international expert consensus

Por: Pingray · V. · Williams · C. R. · Al-beity · F. M. A. · Abalos · E. · Arulkumaran · S. · Blumenfeld · A. · Carvalho · B. · Deneux-Tharaux · C. · Downe · S. · Dumont · A. · Escobar · M. F. · Evans · C. · Fawcus · S. · Galadanci · H. S. · Hoang · D.-T. T. · Hofmeyr · G. J. · Homer · C. · L
Objective

There are no globally agreed on strategies on early detection and first response management of postpartum haemorrhage (PPH) during and after caesarean birth. Our study aimed to develop an international expert’s consensus on evidence-based approaches for early detection and obstetric first response management of PPH intraoperatively and postoperatively in caesarean birth.

Design

Systematic review and three-stage modified Delphi expert consensus.

Setting

International.

Population

Panel of 22 global experts in PPH with diverse backgrounds, and gender, professional and geographic balance.

Outcome measures

Agreement or disagreement on strategies for early detection and first response management of PPH at caesarean birth.

Results

Experts agreed that the same PPH definition should apply to both vaginal and caesarean birth. For the intraoperative phase, the experts agreed that early detection should be accomplished via quantitative blood loss measurement, complemented by monitoring the woman’s haemodynamic status; and that first response should be triggered once the woman loses at least 500 mL of blood with continued bleeding or when she exhibits clinical signs of haemodynamic instability, whichever occurs first. For the first response, experts agreed on immediate administration of uterotonics and tranexamic acid, examination to determine aetiology and rapid initiation of cause-specific responses. In the postoperative phase, the experts agreed that caesarean birth-related PPH should be detected primarily via frequently monitoring the woman’s haemodynamic status and clinical signs and symptoms of internal bleeding, supplemented by cumulative blood loss assessment performed quantitatively or by visual estimation. Postoperative first response was determined to require an individualised approach.

Conclusion

These agreed on proposed approaches could help improve the detection of PPH in the intraoperative and postoperative phases of caesarean birth and the first response management of intraoperative PPH. Determining how best to implement these strategies is a critical next step.

Immediate versus delayed single blastocyst transfer following the first stimulated IVF cycle in the freeze-all strategy: a study protocol for a randomised controlled trial

Por: Li · H. · Zhang · W. · Chen · J. · Lu · X. · Li · L. · Sun · X. · Ng · E. H.
Introduction

In recent years, the use of frozen embryo transfers (FET) has rapidly increased following the freeze-all strategy due to the advantages of increased maternal safety, improved pregnancy rates, lower ectopic pregnancy rates and better obstetric and neonatal outcomes. Currently, there is still no good scientific evidence to support when to perform FET following a stimulated in vitro fertilisation (IVF) cycle in the freeze-all strategy.

Methods/analysis

This will be a randomised controlled trial. A total of 828 women undergoing their first FET following their first stimulated IVF cycle in the freeze-all strategy will be enrolled and randomised into one of the following groups according to a computer-generated randomisation list: (1) the immediate group, in which FET will be performed in the first menstrual cycle following the stimulated IVF cycle; or (2) the delayed group, in which FET will be performed at least in the second menstrual cycle following the stimulated IVF cycle. The primary outcome will be live birth, which is defined as the delivery of any infants at ≥22 gestational weeks with heartbeat and breath.

Ethics/dissemination

Ethical approval was granted by the Ethics Committee of Assisted Reproductive Medicine at the Shanghai JiAi Genetics & IVF Institute (JIAI E2019-15). Written informed consent will be obtained from each woman before any study procedure is performed, according to good clinical practice. The results of this trial will be disseminated in a peer-reviewed journal.

Trial registration number

NCT04371783

Insomnia symptom prevalence in England: a comparison of cross-sectional self-reported data and primary care records in the UK Biobank

Por: de Lange · M. A. · Richmond · R. C. · Eastwood · S. V. · Davies · N. M.
Objectives

We aimed to use a large dataset to compare self-reported and primary care measures of insomnia symptom prevalence in England and establish whether they identify participants with similar characteristics.

Design

Cross-sectional study with linked electronic health records (EHRs).

Setting

Primary care in England.

Participants

163 748 UK Biobank participants in England (aged 38–71 at baseline) with linked primary care EHRs.

Outcome measures

We compared the percentage of those self-reporting ‘usually’ having insomnia symptoms at UK Biobank baseline assessment (2006–2010) to those with a Read code for insomnia symptoms in their primary care records prior to baseline. We stratified prevalence in both groups by sociodemographic, lifestyle, sleep and health characteristics.

Results

We found that 29% of the sample self-reported having insomnia symptoms, while only 6% had a Read code for insomnia symptoms in their primary care records. Only 10% of self-reported cases had an insomnia symptom Read code, while 49% of primary care cases self-reported having insomnia symptoms. In both primary care and self-reported data, prevalence of insomnia symptom cases was highest in females, older participants and those with the lowest household incomes. However, while snorers and risk takers were more likely to be a primary care case, they were less likely to self-report insomnia symptoms than non-snorers and non-risk takers.

Conclusions

Only a small proportion of individuals experiencing insomnia symptoms have an insomnia symptom Read code in their primary care record. However, primary care data do provide a clinically meaningful measure of insomnia prevalence. In addition, the sociodemographic characteristics of people attending primary care with insomnia were consistent with those with self-reported insomnia, thus primary care records are a valuable data source for studying risk factors for insomnia. Further studies should replicate our findings in other populations and examine ways to increase discussions about sleep health in primary care.

Comparative efficacy and acceptability of different exercise patterns for reducing cardiovascular events in pre-diabetes: protocol for a systematic review and network meta-analysis of randomised controlled trials

Por: Zhong · Y. · Lan · M. · Chen · H. · Chen · Y. · Zhang · Y.
Introduction

Exercise has been used to reverse dysglycaemic states in patients with pre-diabetes. Systematic reviews show that exercise is an effective way to reduce the incidence of diabetes, but there is conflicting evidence for reducing the occurrence of cardiovascular events. Therefore, we present a systematic review and network meta-analysis protocol designed to compare the effectiveness of different forms of exercise in reducing cardiovascular events and their tolerability in different populations.

Methods and analysis

We will include all randomised controlled trials and compare one exercise intervention to another. We will compare the following exercise patterns: standard endurance training, strength training, high-intensity interval training, mind-body exercise, and mixed strength and aerobic training. The primary outcomes are the occurrence of major cardiovascular events and the rate of patient attrition during the intervention. We will search major English and Chinese databases as well as trial registry websites for published and unpublished studies. All reference selection and data extraction will be conducted by at least two independent reviewers. We will conduct a random effects model to combine effect sizes and use the surface under the cumulative ranking curve and the mean ranks to rank the effectiveness of interventions. All data will be fitted at WinBUGS in a Bayesian framework and correlation graphs will be plotted using StataSE 14. We will also use the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework to evaluate the quality of evidence for the study results.

Ethics and dissemination

This study does not involve a population-based intervention, and therefore, does not require ethical approval. We will publish the findings of this systematic review in a peer-reviewed scientific journal, and the dataset will be made available free of charge. The completed review will be disseminated electronically in print and on social media, where appropriate.

PROSPERO registration number

CRD42023422737.

Development of family resource indicators for people with schizophrenic disorder in community by modified Delphi method in Beijing, China

Por: Wang · M. · Jin · G. · Li · T. · Pan · Z. · Lu · X. · Wang · X.
Introduction

Most people with schizophrenia in China are supported by their family members in community. The patient’s family is confronted with severe care burden and pressure, which directly affects the caregiver’s own health and social life, and indirectly affects the patient’s rehabilitation. Adequate family resources can reduce the burden and pressure on families. But there is an absence of systematic family resource indicators for people with schizophrenic disorder in China.

Objectives

This study aimed to develop a set of family resource indicators for people with schizophrenic disorder in China.

Design

Preliminary family resource indicators were generated and refined by literature review and an expert consultation meeting. Two rounds of email-based Delphi survey were carried out to identify family resource indicators.

Setting

Two rounds of email-based Delphi survey were performed from July to September 2021 in Beijing, China.

Participants

There were 15 mental health doctors from community health service centres and four psychiatrists from tertiary hospitals, and two primary care researchers from universities in the first and second rounds Delphi survey.

Results

All the 21 experts participated in both rounds of Delphi survey. A total of 46 indicators achieved consensus for inclusion in the final set of indicators after two rounds of Delphi survey. The final set of indicators was grouped into 10 domains: financial support (three indicators), psychological and spiritual support (eight indicators), medical treatment (three indicators), information and education (three indicators), structural support (two indicators), external family resources included social resources (five indicators), cultural resources (two indicators), economic resources (seven indicators), environmental resources (four indicators) and medical resources (nine indicators).

Conclusions

A set of 46 family resource indicators for people with schizophrenic disorder in community was identified by an iterative Delphi process in Beijing, China. However, the indicators still need to be validated by testing in further studies.

Real experience of caregivers of patients with HIV/AIDS from the perspective of iceberg theory: a qualitative research

Por: Tang · J. · Ren · J. · Wang · H. · Shi · M. · Jia · X. · Zhang · L.
Objective

This study aimed to investigate the caregiving behaviours and supportive needs of caregivers of patients with HIV/AIDS and provide a basis for healthcare institutions to carry out caregiver interventions.

Design

A purposive sampling method was used to select 11 caregivers of patients with HIV/AIDS in the Infectious Disease Department of a tertiary hospital in Nanjing, China, to conduct semistructured interviews. Colaizzi analysis was used to collate and analyse the interview data.

Setting

All interviews were conducted at a tertiary hospital specialising in infectious diseases in Nanjing, Jiangsu Province.

Participants

We purposively sampled 11 caregivers of people with HIV/AIDS, including nine women and two men.

Results

Analysing the results from the perspective of iceberg theory, three thematic layers were identified: behavioural, value and belief. The behavioural layer includes a lack of awareness of the disease, physical and mental coping disorders, and an increased sense of stigma; the values layer includes a heightened sense of responsibility, the constraints of traditional gender norms, the influence of strong family values and the oppression of public opinion and morality and the belief layer includes the faith of standing together through storms and stress.

Conclusion

Healthcare professionals should value the experiences of caregivers of patients with HIV/AIDS and provide professional support to improve their quality of life.

Experiences of living with overweight/obesity and early type 2 diabetes in Singapore--a qualitative interview study

Por: Lee · M. · Khoo · H. S. · Krishnasamy · C. · Loo · M. E. · Wong · S. K. W. · Cheng · S. C. · Bei · E. · Tan · S. Y. · Xie · P. · Lee · E. S. · Tang · W. E.
Objectives

To understand the lived experience of adults with overweight/obesity and early type 2 diabetes in a modern urban environment, and the interrelations among the various aspects of these experiences and participants’ attitudes to weight management.

Design

Qualitative inductive approach to analysing data thematically from semistructured interviews and interpreted from a socioecological perspective.

Setting

Primary care clinics located in northern and central Singapore.

Participants

21 patients between 29 and 59 years old who are living with overweight/obese (Body Mass Index of 25.3–44.0kg/m2) and type 2 diabetes for 6 years or less.

Results

The main themes everyday life, people around me and within me pointed to a combination of barriers to weight and health management for participants. These included environmental factors such as easy physical and digital access to unhealthy food, and high-stress work environments; social factors such as ambiguous family support and dietary practices of peers; and individual factors such as challenges with self-regulation, prioritising work, dealing with co-existing medical conditions and the emotional significance of food. While lack of motivation and cultural dietary practices are hard to change, a problem-solving attitude, and presence of role models, may enable behaviour change.

Conclusion

An exploration of the lifeworld of patients with overweight/obese and early type 2 diabetes revealed that work demands, dietary practices in the workplace and at home, and the easy availability of calorie-dense foods afforded by a technology-infused environment hindered the individual’s efforts at maintaining a healthy weight and lifestyle. Policy and initiatives promoting work-life balance as well as individualised interventions can support participants’ stress management, and problem-solving capability for behaviour change. These barriers stemmed from the various domains of the environmental, interpersonal and intrapersonal but were interrelated. They underscored the need for an integrated approach to weight and diabetes management.

Where does physical activity fit into preschool postpandemic? A qualitative exploration with parents, teachers and administrators

Por: Zulauf-McCurdy · C. · Tessema · B. · Tang · R. · Almeida · S. · Tandon · P. S.
Objectives

During the preschool years, children depend on adult caregivers to provide opportunities for physical activity (PA). Research has focused on measuring PA in preschool, as well as barriers and facilitators to children’s PA but caregiver perceptions remain largely unknown especially in light of the COVID-19 pandemic. This study aims to understand the value of PA in preschool following the pandemic from three types of adult caregivers, parents of a young child (n=7), preschool teachers (n=7) and preschool administrators (n=7).

Methods

In-depth qualitative interviews were conducted to explore the following research questions: (a) how do caregivers describe the importance of PA in preschool postpandemic? (b) how do caregivers support and prioritise PA in preschool postpandemic and what challenges do they face in doing so? and (c) how do caregivers interact with one another to promote PA? Qualitative answers were coded using a codebook developed to answer the research questions of interest.

Results

Parents, teachers and administrators all described valuing PA for preschoolers, but each caregiver type described a different way of promoting it. All the caregivers listed barriers that inhibit their ability to prioritise and promote PA, some heightened postpandemic. Lastly, there were limited caregiver interactions when it came to promoting PA, with the burden largely falling on teachers.

Conclusion

Our findings indicate that one particularly important area for intervention is supporting parents, teachers and preschool administrators in creating a shared understanding of the importance of PA for young children and ways to collaborate to promote it.

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

Por: 't Hart · J. W. H. · Noordman · B. J. · Palsgraaf-Huisbrink · J. · Dunkelgrun · M. · Zengerink · H. F. · Birnie · E. · van Det · M. J. · Boerma · E.-J. G. · de Castro · S. M. M. · Hazebroek · E. J. · Langenhoff · B. S. · Verhoef · C. · Apers · J. A.
Introduction

By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery.

Method and analysis

This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs.

Ethics and dissemination

Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences.

Trial registration number

NCT05464394

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