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AnteayerBMJ Open

Meeting high-risk patient pain care needs through intensive primary care: a secondary analysis

Por: Giannitrapani · K. F. · Holliday · J. R. · McCaa · M. D. · Stockdale · S. · Bergman · A. A. · Katz · M. L. · Zulman · D. M. · Rubenstein · L. V. · Chang · E. T.
Objective

Chronic pain disproportionately affects medically and psychosocially complex patients, many of whom are at high risk of hospitalisation. Pain prevalence among high-risk patients, however, is unknown, and pain is seldom a focus for improving high-risk patient outcomes. Our objective is to (1) evaluate pain frequency in a high-risk patient population and (2) identify intensive management (IM) programme features that patients and providers perceive as important for promoting patient-centred pain care within primary care (PC)-based IM.

Design

Secondary observational analysis of quantitative and qualitative evaluation data from a multisite randomised PC-based IM programme for high-risk patients.

Setting

Five integrated local Veterans Affairs (VA) healthcare systems within distinct VA administrative regions.

Participants

Staff and high-risk PC patients in the VA.

Intervention

A multisite randomised PC-based IM programme for high-risk patients.

Outcome measures

(a) Pain prevalence based on VA electronic administrative data and (b) transcripts of interviews with IM staff and patients that mentioned pain.

Results

Most (70%, 2593/3723) high-risk patients had at least moderate pain. Over one-third (38%, 40/104) of the interviewees mentioned pain or pain care. There were 89 pain-related comments addressing IM impacts on pain care within the 40 interview transcripts. Patient-identified themes were that IM improved communication and responsiveness to pain. PC provider-identified themes were that IM improved workload and access to expertise. IM team member-identified themes were that IM improved pain care coordination, facilitated non-opioid pain management options and mitigated provider compassion fatigue. No negative IM impacts on pain care were mentioned.

Conclusions

Pain is common among high-risk patients. Future IM evaluations should consider including a focus on pain and pain care, with attention to impacts on patients, PC providers and IM teams.

Longitudinal symptom profile of palliative care patients receiving a nurse-led end-of-life (PEACH) programme to support preference to die at home

Por: Agar · M. · Xuan · W. · Lee · J. · Barclay · G. · Oloffs · A. · Jobburn · K. · Harlum · J. · Maurya · N. · Chow · J. S. F.
Objectives

Tailored models of home-based palliative care aimed to support death at home, should also ensure optimal symptom control. This study aimed to explore symptom occurrence and distress over time in Palliative Extended And Care at Home (PEACH) model of care recipients.

Design

This was a prospective cohort study.

Setting and participants

Participants were consecutive recipients of the PEACH rapid response nurse-led model of care in metropolitan Sydney (December 2013–January 2017) who were in the last weeks of life with a terminal or deteriorating phase of illness and had a preference to be cared or die at home.

Outcome measures

Deidentified data including sociodemographic and clinical characteristics, and symptom distress scores (Symptom Assessment Score) were collected at each clinical visit. Descriptive statistics and forward selection logistic regression analysis were used to explore influence of symptom distress levels on mode of separation ((1) died at home while still receiving a PEACH package, (2) admitted to a hospital or an inpatient palliative care unit or (3) discharged from the package (alive and no longer requiring PEACH)) across four symptom distress level categories.

Results

1754 consecutive clients received a PEACH package (mean age 70 years, 55% male). 75.7% (n=1327) had a home death, 13.5% (n=237) were admitted and 10.8% (n=190) were still alive and residing at home when the package ceased. Mean symptom distress scores improved from baseline to final scores in the three groups (p

Conclusion

Tailored home-based palliative care models to meet preference to die at home, achieve this while maintaining symptom control. A focus on particular symptoms may further optimise these models of care.

Validation of oxygen saturations measured in the community by emergency medical services as a marker of clinical deterioration in patients with confirmed COVID-19: a retrospective cohort study

Por: Inada-Kim · M. · Chmiel · F. P. · Boniface · M. · Burns · D. · Pocock · H. · Black · J. · Deakin · C.
Objectives

To evaluate oxygen saturation and vital signs measured in the community by emergency medical services (EMS) as clinical markers of COVID-19-positive patient deterioration.

Design

A retrospective data analysis.

Setting

Patients were conveyed by EMS to two hospitals in Hampshire, UK, between 1 March 2020 and 31 July 2020.

Participants

A total of 1080 patients aged ≥18 years with a COVID-19 diagnosis were conveyed by EMS to the hospital.

Primary and secondary outcome measures

The primary study outcome was admission to the intensive care unit (ICU) within 30 days of conveyance, with a secondary outcome representing mortality within 30 days of conveyance. Receiver operating characteristic (ROC) analysis was performed to evaluate, in a retrospective fashion, the efficacy of different variables in predicting patient outcomes.

Results

Vital signs measured by EMS staff at the first point of contact in the community correlated with patient 30-day ICU admission and mortality. Oxygen saturation was comparably predictive of 30-day ICU admission (area under ROC (AUROC) 0.753; 95% CI 0.668 to 0.826) to the National Early Warning Score 2 (AUROC 0.731; 95% CI 0.655 to 0.800), followed by temperature (AUROC 0.720; 95% CI 0.640 to 0.793) and respiration rate (AUROC 0.672; 95% CI 0.586 to 0.756).

Conclusions

Initial oxygen saturation measurements (on air) for confirmed COVID-19 patients conveyed by EMS correlated with short-term patient outcomes, demonstrating an AUROC of 0.753 (95% CI 0.668 to 0.826) in predicting 30-day ICU admission. We found that the threshold of 93% oxygen saturation is prognostic of adverse events and of value for clinician decision-making with sensitivity (74.2% CI 0.642 to 0.840) and specificity (70.6% CI 0.678 to 0.734).

Study of postoperative laryngopharyngeal discomfort: protocol for a single-centre cohort study

Por: Wang · L. F. · Zheng · M.-T. · Liang · N. · Ma · H. N. · Li · W. X.
Introduction

Postoperative laryngopharyngeal discomfort after extubation can lead to severe throat pain, dysphagia, or postoperative tongue oedema. Possible mechanisms include increased oral pressure, obstruction of venous and lymphatic return in the neck, and increased capillary hydrostatic pressure, which leads to oedema of the tongue and upper airway. However, real-time monitoring indicators of anaesthesia are lacking. Therefore, we designed this study to accurately measure the contact force of the tracheal tube on the tongue in different surgical positions during general anaesthesia.

Methods and analysis

This prospective single-centre observational study will enrol 54 patients undergoing elective surgery under general anaesthesia for>2 hours with endotracheal tube application from 1 July 2023 to 30 June 2024. Patients will be divided into the supine (Supine group) and high-risk (Flexion group) groups. Dynamic changes in the contact force between the tracheal tube and tongue will be measured using T-Scan technology. All patients will be followed up for 7 days postoperatively. The primary endpoint is postoperative laryngopharyngeal discomfort. Secondary outcomes include the time to the first successful recovery of oral intake of fluids and solid food, and airway-related events.

Ethics and dissemination

Ethical approval was obtained from the Ethics Committee of Clinical Research of China-Japan Friendship Hospital (2023-KY-219, approved on 14 September 2023). Informed consent will be obtained during anaesthesia evaluation. This study aims to explore the characteristics of the contact force on the tongue caused by endotracheal intubation in different surgical positions and to provide a better understanding of the risk factors and prevention of postoperative laryngopharyngeal discomfort. The findings of this study will be presented at our hospital, reported on ClinicalTrials.gov, and published in peer-reviewed journals.

Trial registration number

NCT05987293.

Impact of COVID-19 on diabetes care: mixed methods study in an Indigenous area of Guatemala

Por: Guarchaj · M. · Tschida · S. · Milian Chew · J. P. · Aguilar · A. · Flood · D. · Fort · M. P. · Morales · L. C. · Mendoza Montano · C. · Rodriguez Serrano · S. N. · Rohloff · P.
Introduction

SARS-CoV-2 has impacted globally the care of chronic diseases. However, direct evidence from certain vulnerable communities, such as Indigenous communities in Latin America, is missing. We use observational data from a health district that primarily serves people of Maya K’iche’ ethnicity to examine the care of type 2 diabetes in Guatemala during the pandemic.

Methods

We used a parallel convergent mixed methods design. Quantitative data (n=142 individuals with diabetes) included glycated haemoglobin (HbA1c), blood pressure, body mass index and questionnaires on diabetes knowledge, self-care and diabetes distress. Quantitative data was collected at two points, at baseline and after COVID restrictions were lifted. For quantitative outcomes, we constructed multilevel mixed effects models with multiple imputation for missing data. Qualitative data included interviews with providers, supervisors and individuals living with diabetes (n=20). We conducted thematic framework analysis using an inductive approach.

Results

Quantitative data was collected between June 2019 and February 2021, with a median of 487 days between data collection points. HbA1c worsened +0.54% (95% CI, 0.14 to 0.94) and knowledge about diabetes decreased –3.54 points (95% CI, –4.56 to –2.51). Qualitatively, the most important impact of the pandemic was interruption of the regular timing of home visits and peer group meetings which were the standard of care.

Conclusions

The deterioration of diabetes care was primarily attributed to the loss of regular contact with healthcare workers. The results emphasize the vulnerability of rural and Indigenous populations in Latin America to the suspension of chronic disease care.

Differences in health literacy related to gestational weight gain and childrens birth weight according to maternal nativity status in the Japan Environment and Childrens Study (JECS): a longitudinal cohort study

Por: Kigawa · M. · Tsuchida · A. · Matsumura · K. · Ito · M. · Tanaka · T. · Hamazaki · K. · Adachi · Y. · Inadera · H. · The Japan Environment and Childrens Study (JECS) Group · Kamijima · Yamazaki · Ohya · Kishi · Yaegashi · Hashimoto · Mori · Ito · Yamagata · Nakayama · Sobue · Shima
Objectives

We examined literacy related to healthy gestational weight gain (GWG) in immigrant and native Japanese mothers and determined whether it is associated with children’s birth weight.

Design

Longitudinal cohort study.

Setting

As the baseline survey in the Japan Environment and Children’s Study (JECS), mothers completed self-administered questionnaires distributed by hand during pregnancy. The self-administered questionnaires used in this study were distributed by mail 6 months after delivery. Children’s birth weight, actual GWG and any complications during delivery were recorded by obstetricians collaborating with JECS.

Participants

Of 97 452 mothers who consented to participate in the JECS during pregnancy between January 2011 and March 2014, 67 953 were included in this study after exclusions for multiple births, multiple instances of consent by the same pregnant woman, miscarriages/stillbirths or withdrawal from the study within 3 years after participating. In total, 324 immigrant mothers and 963 native Japanese mothers were selected by propensity score matching for analysis.

Primary and secondary outcome measures

Data were collected on maternal literacy related to healthy GWG at the baseline survey, and data on actual GWG and children’s birth weight were collected by obstetricians. The associations of knowledge about healthy GWG and mothers’ actual GWG with maternal nativity status were examined using a 2 or Student’s t-test.

Results

More native Japanese mothers than immigrant mothers knew the appropriate GWG and reason the for needing to know this. Actual GWG was significantly higher among the immigrant mothers, but was within the recommended range. The low birthweight (LBW) incidence was significantly higher among the native mothers.

Conclusions

Immigrant mothers to Japan had less knowledge about appropriate GWG, but their actual GWG was appropriate and they delivered fewer LBW infants than native Japanese mothers. These findings may indicate the presence of other protective factors for pregnancy or delivery among immigrant mothers.

How can community pharmacists be supported to manage skin conditions? A multistage stakeholder research prioritisation exercise

Por: Harvey · J. · Shariff · Z. · Anderson · C. · Boyd · M. J. · Ridd · M. J. · Santer · M. · Thomas · K. S. · Maidment · I. · Leighton · P.
Objective

To establish research priorities which will support the development and delivery of community pharmacy initiatives for the management of skin conditions.

Design

An iterative, multistage stakeholder consultation consisting of online survey, participant workshops and prioritisation meeting.

Setting

All data collection took place online with participants completing a survey (delivered via the JISC Online Survey platform, between July 2021 and January 2022) and participating in online workshops and meetings (hosted on Microsoft Teams between April and July 2022).

Participants

174 community pharmacists and pharmacy staff completed the online survey.

53 participants participated in the exploratory workshops (19 community pharmacists, 4 non-pharmacist members of pharmacy staff and 30 members of the public). 4 healthcare professionals who were unable to attend a workshop participated in a one-to-one interview.

29 participants from the workshops took part in the prioritisation meeting (5 pharmacists/pharmacy staff, 1 other healthcare professional and 23 members of the public).

Results

Five broad areas of potential research need were identified in the online survey: (1) identifying and diagnosing skin conditions; (2) skin conditions in skin of colour; (3) when to refer skin conditions; (4) disease-specific concerns and (5) product-specific concerns.

These were explored and refined in the workshops to establish 10 potential areas for research, which will support pharmacists in managing skin conditions. These were ranked in the prioritisation meeting. Among those prioritised were topics which consider how pharmacists work with other healthcare professionals to identify and manage skin conditions.

Conclusions

Survey responses and stakeholder workshops all recognised the potential for community pharmacists to play an active role in the management of common skin conditions. Future research may support this in the generation of resources for pharmacists, in encouraging public take-up of pharmacy services, and in evaluating the most effective provision for dealing with skin conditions.

Stakeholders perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study

Por: Deja · E. · Donohue · C. · Semple · M. G. · Woolfall · K. · for the BESS Investigators · Semple · McNamara · Allen · Fowler · Barker · Peak · Miert · Best · Donohue · Jones · Moitt · Price · Williamson · Clark · Madsen · Dawson · Summers · Deja · Woolfall · Osaghae · Turner · Panchal
Objectives

The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.

Design

A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.

Setting

Fourteen UK paediatric intensive care units.

Participants

Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.

Results

Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.

Conclusion

Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.

Trial registration number

ISRCTN11746266.

Risk factors for cognitive impairment in middle-aged type 2 diabetic patients: a cross-sectional study

Por: Li · Y.-S. · Li · J.-B. · Wang · J.-J. · Wang · X.-H. · Jiang · W.-R. · Qiu · H.-N. · Xia · L.-F. · Wu · F. · Lin · C.-Y. · Liu · Y.-L. · Lin · J.-N.
Objective

The aim of this study was to investigate risk factors for cognitive impairment (CI) and explore the relationship between obesity and cognition in hospitalised middle-aged patients with type 2 diabetes (T2DM).

Methods

Subjects were divided into normal cognitive function (NCF) (n=320) and CI (n=204) groups based on the results of the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE). The risk factors for CI were determined by logistic regression analysis and generalised linear modelling. The associations between obesity parameters (body mass index (BMI) and waist circumference (WC)) and cognitive ability were studied with the use of linear regression analysis, piecewise regression modelling and interaction analysis. The receiver operating characteristic curve analysis was used to examine the diagnostic value of influencing factors for cc

Results

The prevalence of CI was 38.9% in hospitalised middle-aged T2DM patients (median age, 58 years). Age, WC, hypoglycaemic episode within past 3 months and cerebrovascular disease (CVD) were identified as independent risk factors for CI, while the independent protective factors were education, diabetic dietary pattern, overweight and obesity. BMI was a protective factor for the MoCA score within a certain range, whereas WC was a risk factor for the MMSE and MoCA scores. The area under the curve for the combination of BMI and WC was 0.754 (p

Conclusion

Age, education, diabetic dietary pattern, WC, overweight, obesity, hypoglycaemic episode in 3 months and CVD may be potential influencing factors for the occurrence of CI in hospitalised middle-aged population with T2DM. The combination of BMI and WC may represent a good predictor for early screening of CI in this population. Nevertheless, more relevant prospective studies are still needed.

Excess mortality during the COVID-19 pandemic in low-income and lower middle-income countries: protocol for a systematic review and meta-analysis

Por: Gmanyami · J. M. · Jarynowski · A. · Belik · V. · Lambert · O. · Amuasi · J. · Quentin · W.
Introduction

The COVID-19 pandemic has been marked by a massive death toll. However, the overall effect of the pandemic, including potential unintended negative impacts of some control measures, on mortality remains poorly understood in low-income and lower middle-income countries (LLMICs). This review aims to summarise the available literature on excess mortality in LLMICs, focusing on the methods and data sources used in estimating excess mortality and the drivers of excess mortality.

Methods and analysis

We will review the available literature and report results in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis. Searches will be conducted in PubMed, Embase, Web of Science, Cochrane Library, Google Scholar and Scopus. All published studies that report on the estimates of excess mortality in populations of LLMICs will be included. This will include those with a publication date from 2019 onwards and those with at least a 1-year non-COVID-19 period as the comparator in the estimation of excess mortality during the pandemic. There will be no language restrictions on the search. The meta-analysis will include studies with extractable data on excess mortality, methods, population size, and observed and expected deaths. We will use the Mantel-Haenszel method to estimate the pooled risk ratio with 95% CIs.

Ethics and dissemination

As there is no primary data collection, there is no requirement for ethical review. The results will be disseminated through peer-reviewed journal publication and conference presentations.

PROSPERO registration number

CRD42022378267.

Examining age, period and cohort effects in attitude change to childhood vaccinations in a representative New Zealand survey: a multiyear cohort-sequential growth modelling study

Por: Hayes · E. · Yogeeswaran · K. · Zubielevitch · E. · Lee · C. H. J. · Cording · J. · Sibley · C. G.
Objectives

Vaccinations are an important preventative measure in reducing the spread of infectious diseases worldwide. However, concerns of undervaccination during childhood have become increasingly common. The current study aims to investigate changes in attitudes towards childhood vaccinations prior to the COVID-19 pandemic using a national sample from New Zealand.

Design

Age-based, period-based, and cohort-based changes were assessed using cohort-sequential latent growth modelling in 11 overlapping birth cohorts, which spanned the ages of 23–79 years.

Setting and participants

Data were taken from the New Zealand Attitudes and Values Study where 58 654 adults completed at least one wave across a 7-year period (2013 and 2015–2019).

Results

The period-based and cohort-based models fit the data equally well (2(282)=8547.93, p2(273)=8514.87, p

Conclusion

Overall, both the cohort-based and period-based models reveal changes in vaccination attitudes suggesting that even prior to the COVID-19 pandemic, societal influences had an impact on attitudes towards childhood vaccination.

Comparative efficacy of acupuncture-related therapy for postmenopausal osteoporosis: protocol for Bayesian network meta-analysis

Por: Xu · T. · Deng · B. · Lin · S. · Wang · H. · Xu · Y. · Chen · G.
Introduction

The review aims to conduct the first network meta-analysis to comprehensively evaluate the application of multiple acupuncture techniques in patients with postmenopausal osteoporosis, ranking the best acupuncture treatment and providing a reference for clinical treatment extensively.

Methods and analysis

Randomised controlled trials of different acupuncture-related therapies for postmenopausal osteoporosis will be searched in the following databases from 1 January 2002 to 31 December 2022, including PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, VIP Database, Wanfang Database and China Biomedical Literature Database. Overall, clinical efficacy rate, bone mineral density and a Visual Analogue Scale score are used as the primary outcome indicators. In addition, the secondary outcome indicator is adverse reactions. The entire screening process will be conducted by two independent investigators; meanwhile, Stata (V.14.0) and RevMan (V.5.4) will be used to conduct the network meta-analysis. If the data are permissible and feasible, we will also perform meta-regression and subgroup analyses to address the underlying causes of data inconsistency and heterogeneity in the statistical analyses. Besides, to improve the credibility of this network meta-analysis, we will evaluate the quality of evidence in this research according to the GRADE assessment.

Ethics and dissemination

Ethics approval is not required for network meta-analyses, which do not involve animals’ or people’s welfare. The results of this network meta-analysis will be submitted to a recognised journal for publication.

PROSPERO registration number

CRD42023401003.

Effectiveness of CO-OP group intervention for children with developmental coordination disorder: single-case experimental design study protocol

Por: Madieu · E. · Therriault · P.-Y. · Cantin · N. · Baghdadli · A.
Introduction

With the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, children with developmental coordination disorder learn to use a problem-solving strategy to deal with their motor difficulties and perform daily activities of their choice. Therapists use guided discovery to enable children to find their own solutions. Although CO-OP is recommended in a group setting, studies are needed to support its effectiveness.

Methods and analysis

A single-case study design with multiple baselines across participants and four systematic replications will be used. In each of the five groups, four children (aged 8–12 years) will be randomly included at the baseline. The baseline includes 5–8 measurements, and the CO-OP intervention stage is comprised of 10 sessions. The follow-up stage includes five measurements. Prior to baseline, each child in each of the five groups will choose five activities of which three will be carried out during the intervention sessions. Children’s performance in each of these activities will be scored using the Performance Quality Rating Scale (PQRS) as the main measure. Three secondary measures will be collected: perceived activity performance using the Canadian Occupational Performance Measure, quality of life using the Kidscreen-27 and spontaneous motor rhythm using a computerised typing task. Graphed data will be analysed visually at the individual level with the Visual Aid Implying an Objective Rule (VAIOR) protocol which provides a colour code based on the level and trend of two consecutive phases, facilitating an objective visual analysis. Statistics will be performed for PQRS scores at the individual level and at the group level.

Ethics and dissemination

The protocol has been approved by the Comité de protection des personnes Sud-Est I (CPP 2021070) and the Comité d’éthique de la recherche avec les êtres humains de l’Université du Québec à Trois-Rivières (CER-22-294-07.03). Results will be published in a peer-reviewed scientific journal.

Trial registration number

NCT05231486.

Have interventions aimed at assisting general practitioners in facilitating earlier diagnosis of type 1 diabetes in children been successful? A systematic review protocol

Por: Beccia · C. · Hunter · B. · Birkic · V. · White · M. · Manski-Nankervis · J.-A.
Background

Early diagnosis of type 1 diabetes in children is critical to prevent deterioration to diabetic ketoacidosis (DKA), a state where the body’s insulin levels are critically low resulting in the use of fat for fuel and the accumulation of ketones. DKA is a life-threatening emergency where dehydration and cerebral oedema can quickly develop and lead to death. Despite treatment, DKA also has harmful impacts on cognition and brain development. Most children admitted to a hospital with DKA see their general practitioner in the week leading up to their admission. A delay in referral from general practice can result in delays in commencing lifesaving insulin therapy. Prior systematic reviews have explored publicity campaign interventions aimed at recognising type 1 diabetes earlier; however, no reviews have explored these interventions targeted at reducing the delay after presentation to the general practitioner. This systematic review aims to summarise interventions that target the diagnostic delay emerging from general practice and to evaluate their effectiveness in reducing DKA admissions.

Methods

Six databases (Ovid (MEDLINE), Web of Science, EMBASE, CINAHL, Evidence-Based Medicine Reviews (EBMR) and Google Scholar) will be searched to identify studies exploring interventions to reduce diagnostic delay in children with type 1 diabetes, and hence DKA, in general practice. The primary outcome will be the number of DKA admissions to a hospital following a delay in general practice. The secondary outcome will be the behaviour of general practitioners with respect to urgent referral of children with type 1 diabetes. Title, abstract and full-text screening for exclusion and inclusion of publications will be completed by two independent reviewers. Any risks of bias within individual studies will be assessed by two independent reviewers, using the Risk Of Bias In Non-Randomized Studies of Interventions tool. Our confidence in the overall body of evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation.

Ethics and dissemination

The systematic review will be disseminated via publication and potentially in conference presentations. Ethics is not required for a systematic review of secondary data.

PROSPERO registration number

CRD42023412504

Infection prevention and control compliance of healthcare workers towards COVID-19 in conflict-affected public hospitals of Ethiopia

Por: Daba · C. · Atamo · A. · Gebretsadik Weldehanna · D. · Oli · A. · Debela · S. A. · Luke · A. O. · Gebrehiwot · M.
Objective

Non-compliance with COVID-19 infection prevention and control (IPC) is one of the global public health problems particularly among those frontline healthcare workers. However, there are no detailed investigations on COVID-19 IPC compliance among healthcare workers in conflict-affected settings. The objective of this research was to assess compliance with COVID-19 IPC measures and determine the factors associated with it among healthcare providers in Ethiopian governmental hospitals affected by conflict.

Design

A cross-sectional study was carried out within institutional settings.

Study setting and period

The study was conducted in three public hospitals located in northeastern Ethiopia during the period of March to April 2022.

Participants

Simple random sampling technique was used to select 325 healthcare workers after proportional allocation was made to each public hospital.

Primary outcome measures

The primary outcome was non-compliance with COVID-19 IPC. A multivariable logistic regression analysis was employed to identify factors associated with the lack of adherence to the COVID-19 IPC protocol.

Results

Nearly half (150, 46.2%) of the healthcare workers had non-compliance with COVID-19 IPC protocol. Absence of hand washing soap (adjusted OR (AOR)=2.99; 95% CI 2.46 to 5.76), workload (AOR=2.25; 95% CI 1.33 to 3.84), disruption in the supply of piped water (AOR=1.82; 95% CI 1.11 to 2.99), did not undergo training in COVID-19 IPC (AOR=2.85; 95% CI 1.85 to 4.84), absence of COVID-19 IPC guidelines (AOR=2.14; 95% CI 1.11 to 4.13) and chewing khat (AOR=2.3; 95% CI 1.32 to 3.72) were determinant factors for non-compliance.

Conclusions

The magnitude of non-compliance with COVID-19 IPC was high. Hospital managers and federal ministry of health should provide regular training on COVID-19 IPC, continuous piped water and personal protective facilities for healthcare workers. Ultimately, improving the security situation in the area would help improve COVID-19 IPC compliance among healthcare workers in these and other similar conflict-affected settings.

Human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis (MSC-DLC-1): a dose-escalation, phase I trial protocol

Por: Wang · Z. · Li · T. · Zhang · Z. · Yuan · M. · Shi · M. · Wang · F.-S. · Linghu · E.-Q. · Shi · L.
Introduction

There are limited therapeutic options to efficiently treat patients with decompensated liver cirrhosis. This trial aims to explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) for the treatment of patients with decompensated liver cirrhosis.

Methods and analysis

This study is an open-label, dose-escalation, one-armed phase I trial. A single injection of UC-MSCs will be administered in a predetermined dose in each cohort (5.0x107, 1.0x108, 1.5x108 or 2.0x108 cells) according to the ‘3+3’ rule. The primary evaluation measures will include the incidence of adverse events and the change in the Model for End-stage Liver Disease (MELD) score from baseline to the 28th day. Secondary evaluation measures will be evaluated at baseline and at each follow-up point. These measures will include the change in the MELD score from baseline to each follow-up point, the incidence of each complication associated with decompensated cirrhosis, liver transplant-free survival and the incidence of liver failure, among other relevant measures. All patients will be followed up for 24 months. This study will evaluate whether the use of UC-MSCs to treat patients with decompensated liver cirrhosis is safe and tolerable.

Ethics and dissemination

The study has been approved by the Chinese People’s Liberation Army General Hospital (Approval#: 2018-107-D-4). Once conducted, the results from the study will be published in a peer-reviewed journal.

Trial registration number

NCT05227846.

Effects of armed conflict on maternal and infant health: a mixed-methods study of Armenia and the 2020 Nagorno-Karabakh war

Por: Rostomian · L. · Chiloyan · A. · Hentschel · E. · Messerlian · C.
Introduction

Armed conflict worldwide and across history has harmed the health of populations directly and indirectly, including generations beyond those immediately exposed to violence. The 2020 war between Armenia and Azerbaijan over Nagorno-Karabakh, inhabited by an ethnically Armenian population, provides an example of how conflict harmed health during COVID-19. We hypothesised that crises exposure would correspond to decreased healthcare utilisation rates and worse health outcomes for the maternal and infant population in Armenia, compounded during the pandemic.

Methods

Following a mixed-methods approach, we used ecological data from 1980 to 2020 to evaluate health trends in conflict, measured as battle-related deaths (BRDs), COVID-19 cases, and maternal and infant health indicators during periods of conflict and peace in Armenia. We also interviewed 10 key informants about unmet needs, maternal health-seeking behaviours and priorities during the war, collecting recommendations to mitigate the effects of future crisis on maternal and infant health. We followed a deductive coding approach to analyse transcripts and harvest themes.

Results

BRDs totalled more in the 2020 war compared with the previous Nagorno-Karabakh conflicts. Periods of active conflict between 1988–2020 were associated with increased rates of sick newborn mortality, neonatal mortality and pre-eclampsia or eclampsia. Weekly average COVID-19 cases increased sevenfold during the 2020 Nagorno-Karabakh war. Key informants expressed concerns about the effects of stress and grief on maternal health and pregnancy outcomes and recommended investing in healthcare system reform. Participants also stressed the synergistic effects of the war and COVID-19, noting healthcare capacity concerns and the importance of a strong primary care system.

Conclusions

Maternal and infant health measures showed adverse trends during the 2020 Nagorno-Karabakh war, potentially amplified by the concurrent COVID-19 pandemic. To mitigate effects of future crises on population health in Armenia, informants recommended investments in healthcare system reform focused on primary care and health promotion.

Optimisation of Organ Preservation treatment strategies in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy: Additional contact X-ray brachytherapy versus eXtending the observation period and local excision (

Por: Geubels · B. M. · van Triest · B. · Peters · F. P. · Maas · M. · Beets · G. L. · Marijnen · C. A. M. · Custers · P. A. · Rutten · H. J. T. · Theuws · J. C. M. · Verrijssen · A.-S. E. · Cnossen · J. S. · Burger · J. W. A. · Grotenhuis · B. A.
Introduction

Standard treatment for patients with intermediate or locally advanced rectal cancer is (chemo)radiotherapy followed by total mesorectal excision (TME) surgery. In recent years, organ preservation aiming at improving quality of life has been explored. Patients with a complete clinical response to (chemo)radiotherapy can be managed safely with a watch-and-wait approach. However, the optimal organ-preserving treatment strategy for patients with a good, but not complete clinical response remains unclear. The aim of the OPAXX study is to determine the rate of organ preservation that can be achieved in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy by additional local treatment options.

Methods and analysis

The OPAXX study is a Dutch multicentre study that investigates the efficacy of two additional local treatments aiming at organ preservation in patients with a good, but not complete response to neoadjuvant treatment (ie near-complete response or a small residual tumour mass

Ethics and dissemination

The trial protocol has been approved by the medical ethics committee of the Netherlands Cancer Institute (METC20.1276/M20PAX). Informed consent will be obtained from all participants. The trial results will be published in an international peer-reviewed journal.

Trial registration number

NCT05772923.

Northern Shanghai Study II: systematic assessment and management of early organ damage and its role in preventing and reducing cardiovascular risk--protocol of a prospective study

Por: Hou · J. · Li · M. · Han · J. · Yu · S. · Jia · X. · Sun · F. · Zhang · Y.
Introduction

Cardiovascular diseases are the leading cause of death and disease burden in China. However, there is a lack of prospective cohort studies suitable for evaluating early organ damage and its role in preventing and reducing cardiovascular risk among Chinese residents. This study intends to establish the first database based on the phenotypes of all early structural and functional damage of cardiovascular organs in Chinese population. Moreover, a digital follow-up mechanism will be formed, a prospective population cohort will be established, a biological sample bank for early cardiovascular organ damage will be established, and an intervention and management system for early damage of cardiovascular organs will be explored.

Methods and analysis

This study is a prospective cohort study built on the foundation of the Northern Shanghai Study I. People aged 18–75 years are enrolled. After the recruitment, first, corresponding physical measurements and clinical examinations are conducted to collect cardiovascular risk factors and establish the demographic baseline of the study population. Next, the latest equipment is used to evaluate early structural and functional cardiovascular organ damage including heart, macrovessels, microcirculation, renal function and fundus. Meanwhile, the blood, urine, faeces and other biological samples of participants are collected to establish the cardiometabolic and gut microbiota analysis databases. The population is followed up every 2 years. Comprehensive assessment of early organ damage will be used to predict cardiovascular risk, guide people to change lifestyles to achieve early prevention and provide corresponding treatment recommendations.

Ethics and dissemination

This study was approved by the Shanghai Tenth People’s Hospital Institutional Review Board. All participants signed a written consent form. The results of this study will be disseminated in peer-reviewed journals. Ethics approval: SHYS-IEC-5.0/22k148/P01.

Trial registration number

NCT05435898.

Attitude of cardiac surgery nurses on kinesiophobia management: a qualitative study

Por: Wang · Y. · Chen · Y. · Zhang · X. · Liu · S.
Objectives

This study aimed to investigate the knowledge, attitudes and practical experiences of cardiac surgery nurses regarding kinesiophobia management during early mobilisation.

Design

Using a descriptive qualitative research method, 21 cardiac surgery nurses participated in this study from October 2022 to January 2023, and the interview data were analysed using the Colaizzi 7-step analysis method.

Setting

Data were collected through in-depth face-to-face or online interviews in a tertiary hospital located in Nanjing, China.

Participants

21 cardiac surgery nurses were interviewed from October 2022 to January 2023.

Results

Two themes were summarised: knowledge, attitude and practice of nurses (high recognition and low participation; low knowledge reserve; low willingness); the promotion and essential elements of kinesiophobia management (efficient health education model; stable medical staff–family caregiver collaboration; simplified clinical protocol; specialist nursing team; clarify the multidisciplinary division of labour).

Conclusion

The management of kinesiophobia in patients undergoing cardiac surgery is currently in the developmental phase. It is advisable to give due consideration to emotional support and cognitive training for medical staff. In addition, a workable management plan, consistent with clinical practice, should be formulated through multidisciplinary and medical staff–family caregiver collaboration to optimise patient outcomes.

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