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Supervisors approaches to the early entrustment of clinical tasks: an observational study in general practice

Objectives

At the very start of medical residency training, entrustment of clinical tasks may be a major challenge, on which current scientific knowledge is scarce. This study therefore aimed to gain insight into the process of supervisors’ decision making underlying the entrustment of clinical tasks at the start of one-on-one supervisor–trainee working relationships.

Setting

This study was performed in a general practice (GP) training department in the Netherlands.

Participants

For this study, we recruited supervisor–trainee pairs who were just about to start the first year of GP residency training. Of 10 eligible supervisor–trainee pairs, 4 participated.

Design

We used a qualitative, social-constructivist research approach. Data from naturalistic non-participant observations and semistructured interviews with supervisors in four GP practices were triangulated and analysed using a thematic analysis approach.

Results

Supervisors’ early entrustment decisions were based on generic trainee qualities such as self-reflexivity, knowing one’s limitations and asking for help in time, rather than on task-specific performance. At the start of residency training, supervisors’ primary concern was to create a safe working and learning environment in which trainees could and would ask for timely supervision while being entrusted with challenging tasks. Supervisors used idiosyncratic entrustment strategies that were influenced by their propensity to trust, previous experiences with trainees, and their perspective on learning and teaching.

Conclusion

Entrustment decisions require high levels of safety for all stakeholders involved. Especially at the beginning of supervisor–trainee relationships, establishing an educational alliance in which entrustment is the subject of ongoing trainee–supervisor conversations is essential to achieve and maintain and optimal balance between trainee learning and patient safety. Additional research may further our understanding of early entrustment decision making and the role of generic trainee qualities in different settings.

Global impact of COVID-19 on surgeons and team members (GlobalCOST): a cross-sectional study

Por: Jaffry · Z. · Raj · S. · Sallam · A. · Lyman · S. · Negida · A. · Yiu · C. F. A. · Sobti · A. · Bua · N. · Field · R. E. · Abdalla · H. · Hammad · R. · Qazi · N. · Singh · B. · Brennan · P. A. · Hussein · A. · Narvani · A. · Jones · A. · Imam · M. A. · The OrthoGlobe Collaborative · Abbas
Objectives

To investigate the impact of COVID-19 on the well-being of surgeons and allied health professionals as well as the support provided by their institutions.

Design

This cross-sectional study involved distributing an online survey through medical organisations, social media platforms and collaborators.

Setting

It included all staff based in an operating theatre environment around the world.

Participants

1590 complete responses were received from 54 countries between 15 July and 15 December 2020. The average age of participants was 30–40 years old, 64.9% were men and 32.5% of a white ethnic background. 79.5% were surgeons with the remainder being nurses, assistants, anaesthetists, operating department practitioners or classified other.

Main outcome measures

Participants that had experienced any physical illness, changes in mental health, salary or time with family since the start of the pandemic as well as support available based on published recommendations.

Results

32.0% reported becoming physically ill. This was more likely in those with reduced access to personal protective equipment (OR 4.62; CI 2.82 to 7.56; p

Conclusions

This work has highlighted a need and strategies to improve conditions for the healthcare workforce, ultimately benefiting patient care.

Prevalence and factors associated with self-reported injuries in Nepal: a secondary analysis of the nationally representative cross-sectional STEPS Survey, 2019

Por: Dhimal · M. · Poudyal · A. · Bista · B. · Dahal · S. · Raj Pant · P. · Gyanwali · P.
Objective

This study aims to determine the prevalence and factors associated with injuries in the adult population of Nepal.

Design and participants

Secondary analysis of the data from the cross-sectional WHO STEPwise Approach to NCD Risk Factor Surveillance (STEPS) Survey Nepal, 2019. A multistage cluster sample of 5593 adults aged 15–69 years who have been the usual residents of the household for at least 6 months. A binary logistic regression model was employed to identify the determinants of injuries.

Setting

Data were derived from the STEPS Survey Nepal, 2019.

Primary and secondary outcome measures

The primary outcome was injured person defined as one who had road traffic injuries (RTIs), had other serious unintentional/accidental injury, or had been seriously injured in a violent incident within the past 12 months. The secondary outcome measure was factors associated with injuries.

Results

Over 11% of the 4996 study participants reported any injuries during the past 12 months. About 3.75% of the participants experienced a RTI, 4.71% had experienced unintentional injuries other than RTI, while 5.33% had been injured in violent incidents. Individuals belonging to the middle wealth quintile (crude OR (COR)=2.95, 95% CI 1.27 to 6.84) were associated with increased odds of RTIs. By occupation, homemaker (COR=0.45, 95% CI 0.24 to 0.84) was protective against these injuries. Likewise, currently married individuals (COR=3.74, 95% CI 1.37 to 10.17), ever married individuals (COR=3.49, 95% CI 1.08 to 11.25) and individuals not in employment (COR=2.13, 95% CI 1.16 to 3.91) were associated with an increased likelihood of sustaining an intentional injury. Injuries were higher among rural participants.

Conclusions

This study provides the baseline population-based estimates of the prevalence of injuries in Nepal. It describes the mechanisms and risk factors of these injuries. It is hoped that this evidence will serve as a stimulus for future studies to elucidate comprehensive national information about injuries.

Association between transoesophageal echocardiography monitoring indicators and the incidence of postoperative acute kidney injury in coronary artery bypass grafting: a study protocol for a prospective multicenter cohort study

Por: Liu · B. · Lv · M. · Wang · H. · Sun · Y. · Song · X. · Dong · L. · Feng · H. · Wang · Y.
Introduction

Previous studies on transoesophageal echocardiography in coronary artery bypass grafting mainly focused on whether to change the surgical plan rather than improve the clinical prognosis. Currently, there are sparse studies on the relationship between transoesophageal echocardiography indicators and the prognosis of patients undergoing coronary artery bypass grafting. The primary aim of this study is to explore the association between transoesophageal echocardiography monitoring indicators the respiratory variability of inferior vena cava diameter, tricuspid annular plane systolic excursion and the incidence of acute kidney injury in coronary artery bypass grafting patients.

Methods and analysis

We designed this prospective multicenter cohort study, which included approximately 150 adult patients (≥18 years) undergoing elective coronary artery bypass surgery. Different hospitals will be assessed to obtain information on the prevalence, risk factors, management strategies and outcomes in coronary artery bypass surgery. The cohort will be followed after the coronary artery bypass surgery period, up to 30 days after enrolment. The incidence of postoperative acute kidney injury and baseline data will be presented by descriptive statistics. We will use Freidman inspection and multivariable logistic regression to assess the association between transoesophageal echocardiography monitoring indicators and the incidence of acute kidney injury in coronary artery bypass grafting patients.

Ethics and dissemination

The study has been approved by the ethics committee of Shandong Provincial Qianfoshan Hospital, China (approval number: YXLL-KY-2021(067)). This is an observational study that poses no risk to the patients. All participants will obtain informed consent according to the ethics committee before patient enrolment. Funding sources will have no influence on data handling, analyses or writing of the manuscript. The article is planned for submission in an international peer-reviewed journal.

Trial registration number

NCT05139108.

Time intervals from first symptom recognition to pathological diagnosis among patients with oesophageal cancer in Ethiopia: a cross-sectional study

Por: Dessalegn · B. · Getachew · S. · Yirgu · R. · Enqueselassie · F. · Assefa · M. · Addissie · A.
Objective

The aim of this study was to estimate the time intervals from first symptom recognition to pathological diagnosis among patients with oesophageal cancer in Ethiopia.

Methods

Design

A cross-sectional study design was employed.

Settings and participants

Patients with oesophageal cancer aged ≥18 years were included from Addis Ababa, Ethiopia (n=338) from February 2019 to August 2020. The participants were selected consecutively from six health facilities that provided cancer care nearly for 90% of patients.

Main outcomes and measurements

The Aarhus statement criteria were applied to classify patient intervals (time from first symptom recognition to presentation) and diagnostic intervals (time from first presentation to diagnosis). Patient and diagnostic intervals >60 and >30 days were considered as delays, respectively. For tumour classification, the American Joint Committee on Cancer was used. Data were analysed using SPSS V.24. Descriptive statistics were applied to describe patients’ characteristics. Poisson regression with robust variance was used to compute prevalence ratios. In all statistical tests, significance was declared at a p value of

Results

The mean (SD) age of the participants was 54.30±12.49 years.

Approximately 78% of study participants had never heard of oesophageal cancer and thought they had gastritis. Dysphagia was the commonly mentioned symptom. About 76% of the cases were diagnosed at advanced stages (III and IV). Median patient interval was 108.5 (60.5–215) days and median diagnostic interval was 77.5 (39–133) days. After adjusting confounders, being single and unawareness of oesophageal cancer had association with consultation delay; cost of transportation and medical consultation had association with diagnostic delay; and patient delay of >2 months had association with late-stage diagnosis.

Conclusion

Patients with oesophageal cancer in Ethiopia had prolonged patient and diagnostic intervals. Increasing awareness of symptoms of oesophageal cancer and shortening time to diagnosis will help to improve the outcome of oesophageal cancer care in Ethiopia.

How can equitable video visit access be delivered in primary care? A qualitative study among rural primary care teams and patients

Por: Goldstein · K. M. · Perry · K. R. · Lewinski · A. · Walsh · C. · Shepherd-Banigan · M. E. · Bosworth · H. B. · Weidenbacher · H. · Blalock · D. V. · Zullig · L. L.
Objective

The COVID-19 pandemic sparked exponential growth in video visit use in primary care. The rapid shift to virtual from in-person care exacerbated digital access disparities across racial groups and rural populations. Moving forward, it is critical to understand when and how to incorporate video visits equitably into primary care. We sought to develop a novel clinical algorithm to guide primary care clinics on how and when to employ video visits as part of care delivery.

Design

Qualitative data collection: one team member conducted all patient semistructured interviews and led all focus groups with four other team members taking notes during groups.

Setting

3 rural primary care clinics in the USA.

Participants

24 black veterans living in rural areas and three primary care teams caring for black veterans living in rural areas.

Primary and secondary outcome measures

Findings from semistructured interviews with patients and focus groups with primary care teams.

Results

Key issues around appropriate use of video visits for clinical teams included having adequate technical support, encouraging engagement during video visits and using video visits for appropriate clinical situations. Patients reported challenges with broadband access, inadequate equipment, concerns about the quality of video care, the importance of visit modality choice, and preferences for in-person care experience over virtual care. We developed an algorithm that requires input from both patients and their care team to assess fit for each clinical encounter.

Conclusions

Informed matching of patients and clinical situations to the right visit modality, along with individual patient technology support could reduce virtual access disparities.

Diabetes among adults in Bangladesh: changes in prevalence and risk factors between two cross-sectional surveys

Por: Chowdhury · M. A. B. · Islam · M. · Rahman · J. · Uddin · M. J. · Haque · M. R.
Objective/research question

To investigate the change in the prevalence and risk factors of diabetes among adults in Bangladesh between 2011 and 2018.

Design

The study used two waves of nationally representative cross-sectional data extracted from the Bangladesh Demographic and Health Surveys in 2011 and 2017–2018.

Setting

Bangladesh.

Participants

14 376 adults aged ≥35 years.

Primary outcome

Diabetes mellitus (type 2 diabetes).

Results

From 2011 to 2018, the diabetes prevalence among adults aged ≥35 years increased from 10.95% (880) to 13.75% (922) (p

Conclusion

A high prevalence of diabetes was observed and it has been steadily increasing over time. To enhance diabetes detection and prevention among adults in Bangladesh, population-level interventions focusing on health education, including a healthy diet and lifestyle, are required.

Live well, die well - an international cohort study on experiences, concerns and preferences of patients in the last phase of life: the research protocol of the iLIVE study

Por: Yildiz · B. · Allan · S. · Bakan · M. · Barnestein-Fonseca · P. · Berger · M. · Boughey · M. · Christen · A. · De Simone · G. G. · Egloff · M. · Ellershaw · J. · Elsten · E. E. C. M. · Eychmüller · S. · Fischer · C. · Fürst · C. J. · Geijteman · E. C. T. · Goldraij · G. · Goossense
Introduction

Adequately addressing the needs of patients at the end of life and their relatives is pivotal in preventing unnecessary suffering and optimising their quality of life. The purpose of the iLIVE study is to contribute to high-quality personalised care at the end of life in different countries and cultures, by investigating the experiences, concerns, preferences and use of care of terminally ill patients and their families.

Methods and analysis

The iLIVE study is an international cohort study in which patients with an estimated life expectancy of 6 months or less are followed up until they die. In total, 2200 patients will be included in 11 countries, that is, 200 per country. In addition, one relative per patient is invited to participate. All participants will be asked to fill in a questionnaire, at baseline and after 4 weeks. If a patient dies within 6 months of follow-up, the relative will be asked to fill in a post-bereavement questionnaire. Healthcare use in the last week of life will be evaluated as well; healthcare staff who attended the patient will be asked to fill in a brief questionnaire to evaluate the care that was provided. Qualitative interviews will be conducted with patients, relatives and healthcare professionals in all countries to gain more in-depth insights.

Ethics and dissemination

The cohort study has been approved by ethics committees and the institutional review boards (IRBs) of participating institutes in all countries. Results will be disseminated through the project website, publications in scientific journals and at conferences. Within the project, there will be a working group focusing on enhancing the engagement of the community at large with the reality of death and dying.

Trial registration number

NCT04271085.

Healthcare workers compliance with COVID-19 preventive measures, and associated factors, in Ethiopia: A systematic review and meta-analysis

Por: Zenbaba · D. · Sahiledengle · B. · Beressa · G. · Desta · F. · Atlaw · D. · Bogale · D. · Chattu · V. K.
Objective

Compliance with COVID-19 prevention measures limits infection occurrence and spread in healthcare settings. According to research conducted in Ethiopia, compliance with COVID-19 preventative strategies is inconsistent among healthcare providers. This systematic review and meta-analysis aimed to estimate the national pooled proportion of healthcare workers (HCWs) who adhere to COVID-19 preventive measures and associated factors with good compliance.

Design

A systematic review and meta-analysis of all identified studies with cross-sectional study design.

Data sources

A comprehensive search was conducted in PubMed/MEDLINE, POPLINE, HINARI, Science Direct, Cochrane Library databases and Google Scholar search engines from January 2020 to September 2021.

Data extraction and synthesis

This review included all observational studies conducted in Ethiopia that reported the proportion of compliance with COVID-19 preventive measures and associated factors among HCWs. Two independent authors assessed the methodological quality of studies using Joanna Briggs Institute’s meta-analysis of statistical assessment and review instrument. The effect estimates for pooled proportion and pooled OR (POR) were determined.

Results

From retrieved 611 original studies, 21 studies were included in the meta-analysis with a total of n=7933 HCWs. The pooled proportion of good compliance with COVID-19 preventive measures among HCWs was 49.7% (95% CI: 42.3% to 57.1%). Being male (POR=2.21, 95% CI: 1.52 to 3.21), service years (>3 years) (POR=2.65, 95% CI: 1.94 to 3.64), training (POR=2.30, 95% CI: 1.78 to 2.98), positive attitude (POR=3.14, 95% CI: 1.66 to 5.94) and good knowledge (POR=2.36, 95% CI: 1.92 to 2.89) were factors significantly associated with good compliance towards COVID-19 preventive measures.

Conclusion

Our study indicated that approximately one in every two HCWs had good compliance with COVID-19 preventive measures. There must be more emphasis on providing further training sessions for the HCWs to improve their compliance with COVID-19 preventative measures.

Evaluating the Management of chronic Pelvic girdle Pain following pregnancy (EMaPP): study protocol for a randomised controlled feasibility trial to compare a customised pelvic orthosis with standard care

Por: Halliday · B. J. · Chatfield · S. · Cameron · L. · Hosking · J. · Shawe · J. · Hawton · A. · Hayward · C. · Carter · K. · Freeman · J. A.
Introduction

An estimated 10% of women experience severe, chronic pelvic girdle pain post partum. This has significant physical, psychological and socioeconomic consequences. Typically, such pain is recalcitrant to conservative management; hence the need to identify effective management strategies. Customised Dynamic Elastomeric Fabric Orthoses may be an option to address this gap; designed to improve pain by providing support while optimising movement and function. Currently, no studies have evaluated the clinical and cost-effectiveness, or acceptability of these customised orthoses in postpartum women.

Methods and analysis

EMaPP is a pragmatic, multicentre randomised controlled feasibility trial with an embedded qualitative study and economic evaluation. Sixty participants with pregnancy-related severe pelvic girdle pain >3 months post partum will be recruited. Participants will be randomly allocated in a 1:1 ratio (stratified by centre and presence/absence of lumbo-pelvic pain pre pregnancy) to receive either standard care (standardised information and exercise) or intervention (orthosis plus standard care). All participants will be asked to complete a battery of self-report questionnaires (including pain, function, health-related quality of life and health and social care resource use), via a web-based application at baseline, 12 weeks and 24 weeks. Pain levels and medication usage will be reported fortnightly. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates and intervention adherence. Five clinicians and 10 participants will be interviewed to explore their experiences of the trial procedures and receiving the intervention.

Ethics and dissemination

This study was approved by: National Research Ethics Scheme (NRES Committee Health and Care Research Wales Research Ethics Committee (21/WM/0155) and University of Plymouth Faculty of Health Research Ethics and Integrity Committee (ref:2966). Results will be made available to participants, the funders, staff, general public and other researchers through a range of mechanisms.

Trial status

Currently recruiting.

Trial registration number

ISRCTN67232113.

Hesitancy and reactogenicity to mRNA-based COVID-19 vaccines–Early experience with vaccine rollout in a multi-site healthcare system

by Sarah Al-Obaydi, Eileen Hennrikus, Nazar Mohammad, Erik B. Lehman, Abhishek Thakur, Taha Al-Shaikhly

Background

Hesitancy and incomplete vaccination against coronavirus disease 2019 (COVID-19) remains an obstacle to achieving herd immunity. Because of fear of vaccine reactions, patients with medical and allergic co-morbidities express heightened hesitancy. Limited information is available to guide these patients. We sought to identify factors associated with mRNA-based COVID-19 vaccines hesitancy and reactogenicity.

Methods

We surveyed employees of a multi-site health system in central Pennsylvania who were offered the COVID-19 vaccine (N = 18,740) inquiring about their experience with the Moderna and Pfizer-BioNTech mRNA-based vaccines. The survey was administered online using the REDCap platform. We used multivariable regression analysis to determine whether a particular factor(s) (e.g., demographics, selected co-morbid allergic and medical conditions, vaccine brand, and prior COVID-19) were associated with vaccine reactogenicity including the occurrence and severity of local and systemic reactions. We also explored factors and reasons associated with vaccine hesitancy.

Results

Of the 5709 who completed the survey (response rate, 30.4%), 369 (6.5%) did not receive the vaccine. Black race and allergy to other vaccines were associated with vaccine hesitancy. Reaction intensity following the first vaccine dose and allergic co-morbidities were associated with incomplete vaccination. Older individuals (>60 years) experienced less reactogenicity. Females had higher odds of local and systemic reactions and reported more severe reactions. Asians reported more severe reactions. As compared to Pfizer-BioNTech, the Moderna vaccine was associated with higher odds of vaccine reactions of higher severity. Prior COVID-19 resulted in more severe reactions following the first dose, but less severe reactions following the second dose.

Conclusions

Targeted campaigns to enhance vaccination acceptance should focus on Black individuals, females, and those with allergic co-morbidities. Prior COVID-19 caused more severe reactions after the first but not the second vaccine dose. Moderna vaccine caused more vaccine reactions. Lessons learned from the early rollout of COVID-19 vaccine may serve to inform future novel vaccine experiences.

Health insurance and financial hardship in cancer survivors during the COVID-19 pandemic

by Courtney P. Williams, Gabrielle B. Rocque, Nicole E. Caston, Kathleen D. Gallagher, Rebekah S. M. Angove, Eric Anderson, Janet S. de Moor, Michael T. Halpern, Anaeze C. Offodile II, Risha Gidwani

Uninsured or underinsured individuals with cancer are likely to experience financial hardship, including forgoing healthcare or non-healthcare needs such as food, housing, or utilities. This study evaluates the association between health insurance coverage and financial hardship among cancer survivors during the COVID-19 pandemic. This cross-sectional analysis used Patient Advocate Foundation (PAF) survey data from May to July 2020. Cancer survivors who previously received case management or financial aid from PAF self-reported challenges paying for healthcare and non-healthcare needs during the COVID-19 pandemic. Associations between insurance coverage and payment challenges were estimated using Poisson regression with robust standard errors, which allowed for estimation of adjusted relative risks (aRR). Of 1,437 respondents, 74% had annual household incomes

Patient-reported factors associated with avoidance of in-person care during the COVID-19 pandemic: Results from a national survey

by Bengt B. Arnetz, Courtney Goetz, John vanSchagen, William Baer, Stacy Smith, Judith E. Arnetz

Background

There has been a substantial decline in in-person care in inpatient and outpatient settings during the ongoing COVID-19 pandemic. Avoidance of needed in-person care may contribute to an avoidable decline in patient health and an increase in mortality. While several systems and behavioral theories have been put forward to explain the decline, there is a lack of studies informed by patients’ own experiences. The current study applied a socio-ecological model encompassing patient, environmental, and institutional-related variables to examine patient-reported factors associated with avoidance of in-person care.

Methods

Between October and December 2020, a total of 3840 persons responded to a nationwide online questionnaire that was administered using ResearchMatch and Facebook. Self-reported avoidance of in-person care among those who needed it was the main outcome. Multivariable logistic regression analysis was used to identify factors associated with avoidance of needed care.

Findings

Out of a total of 3372 respondents who reported that they needed in-person care during the early phase of the pandemic, 257 (7.6%) avoided it. Patient-related variables associated with avoiding needed care included younger age (odds ratio (OR), 1.46, 95% CI 1.11 to 1.94, p Conclusions

These results suggest that care avoidance of in-person care during the initial phase of the pandemic was influenced by a patient’s demographics as well as environmental and healthcare institutional factors. Patients’ previous experiences and their awareness of healthcare systems’ safety protocols are important factors in care avoidance.

Clinical practice guidelines and expert consensus statements on rehabilitation for patients with COVID-19: protocol for a systematic review

Por: Zhang · Y. · Li · Y.-X. · Zhong · D.-L. · Liu · X.-B. · Zhu · Y.-Y. · Jin · R.-J. · Li · J.
Introduction

COVID-19 is a highly infectious disease, characterised by respiratory, physical and psychological dysfunctions. Rehabilitation could effectively alleviate the symptoms and promote recovery of the physical and mental health of patients with COVID-19. Recently, rehabilitation medical institutions have issued clinical practice guidelines (CPGs) and expert consensus statements involving recommendations for rehabilitation assessments and rehabilitation therapies for COVID-19. This systematic review aims to assess the methodological quality and reporting quality of the guidance documents, evaluate the heterogeneity of the recommendations and summarise the recommendations with respect to rehabilitation assessments and rehabilitation therapies for COVID-19 to provide a quick reference for front-line clinicians, therapists and patients as well as reasonable suggestions for future guidelines.

Methods and analysis

The electronic databases including PubMed, Embase, Chinese Biomedical Literature Database (CBM), Chinese Science and Technology Periodical Database (VIP), Wanfang Database and China National Knowledge Infrastructure (CNKI) and websites of governments or organisations (eg, National Guideline Clearinghouse, Guidelines International Network, National Institute for Health and Clinical Excellence, Scottish Intercollegiate Guidelines Network and WHO) will be searched for eligible CPGs and expert consensus statements from inception to August 2022. CPGs and expert consensus statements published in Chinese or English and presenting recommendations for modern functional rehabilitation techniques and/or traditional Chinese medicine rehabilitation techniques for COVID-19 will be included. Reviews, interpretations, old versions of CPGs and expert consensus statements and those for the management of other diseases during the pandemic will be excluded. Two reviewers will independently review each article, extract data, appraise the methodological quality following the Appraisal of Guidelines for Research & Evaluation II tool and assess the reporting quality with the Reporting Items for Practice Guidelines in Healthcare statement. The Measurement Scale of Rate of Agreement will be used to evaluate the heterogeneity of the recommendations in different CPGs and expert consensus statements. Agreement between reviewers will be calculated using the intraclass correlation coefficient. We will also summarise the recommendations for rehabilitation in patients with COVID-19. The results will be narratively described and presented as tables or figures.

Ethics and dissemination

Ethics approval is not needed for this systematic review because information from published documents will be used. The findings will be submitted for publication in a peer-reviewed journal and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

PROSPERO registration number

CRD42020190761.

Efficacy and safety of different modes of exercise-based cardiac rehabilitation delivery for patients with heart failure: a protocol for a systematic review and network meta-analysis

Por: Jiang · L. · Wan · R. · Li · B. · Huang · X. · Xu · Y. · Wu · K. · Xu · J. · Lu · Y.
Introduction

The prevalence of heart failure (HF) is increasing. Exercise-based cardiac rehabilitation (CR) reduces mortality and further improves the prognosis of patients with HF. However, the effect of different modes of CR delivery on HF remains unclear. Thus, the purpose of this study is to find out the relative efficacy and safety of different modes of CR delivery for individuals with HF using a network meta-analysis.

Methods and analysis

We will perform a systematic review and network meta-analysis of randomised controlled trials which compare different modes of exercise-based CR delivery for patients with HF. Databases including Embase, Medline, the Cochrane Central Register of Controlled Trials and Web of Science will be searched up to May 2022. The primary outcomes will focus on the functional capacity and the health-related quality of life (hr-QOL). Functional capacity will be evaluated by peak oxygen consumption (mL/kg/min) and 6 min walking test (metres). The Minnesota Living with Heart Failure questionnaire, Short Form-36, Psychometric properties of the Kansas City cardiomyopathy questionnaire and EuroQol five dimensions questionnaire will serve as measures of hr-QOL. As secondary outcomes, we will assess hospital admissions (all-cause and cardiac) and all-cause mortality, which required a minimum follow-up of 6 months, as well as adverse events during exercise training. The risk of bias for individual studies will be evaluated according to the Cochrane Handbook. The quality of evidence will be assessed by the Grading of Recommendations, Assessment, Development and Evaluation approach.

Ethics and dissemination

This study does not require ethics approval as it is based on published trials. Results of this systematic review and network meta-analysis will be submitted to a peer-reviewed journal for future publication.

Trial registration number

CRD42021278351.

Long-term and serious harms of medical cannabis and cannabinoids for chronic pain: a systematic review of non-randomised studies

Por: Zeraatkar · D. · Cooper · M. A. · Agarwal · A. · Vernooij · R. W. M. · Leung · G. · Loniewski · K. · Dookie · J. E. · Ahmed · M. M. · Hong · B. Y. · Hong · C. · Hong · P. · Couban · R. · Agoritsas · T. · Busse · J. W.
Objective

To establish the prevalence of long-term and serious harms of medical cannabis for chronic pain.

Design

Systematic review and meta-analysis.

Data sources

MEDLINE, EMBASE, PsycINFO and CENTRAL from inception to 1 April 2020.

Study selection

Non-randomised studies reporting on harms of medical cannabis or cannabinoids in adults or children living with chronic pain with ≥4 weeks of follow-up.

Data extraction and synthesis

A parallel guideline panel provided input on the design and interpretation of the systematic review, including selection of adverse events for consideration. Two reviewers, working independently and in duplicate, screened the search results, extracted data and assessed risk of bias. We used random-effects models for all meta-analyses and the Grades of Recommendations, Assessment, Development and Evaluation approach to evaluate the certainty of evidence.

Results

We identified 39 eligible studies that enrolled 12 143 adult patients with chronic pain. Very low certainty evidence suggests that adverse events are common (prevalence: 26.0%; 95% CI 13.2% to 41.2%) among users of medical cannabis for chronic pain, particularly any psychiatric adverse events (prevalence: 13.5%; 95% CI 2.6% to 30.6%). Very low certainty evidence, however, indicates serious adverse events, adverse events leading to discontinuation, cognitive adverse events, accidents and injuries, and dependence and withdrawal syndrome are less common and each typically occur in fewer than 1 in 20 patients. We compared studies with

Conclusions

There is very low certainty evidence that adverse events are common among people living with chronic pain who use medical cannabis or cannabinoids, but that few patients experience serious adverse events.

Retrospective evaluation of ophthalmological and neurological outcomes for infants born before 24 weeks gestational age in a Swedish cohort

Por: Hellström · A. · Jacobson · L. · Al-Hawasi · A. · Hellström-Westas · L. · Rakow · A. · Johnson · M. · Sävman · K. · Holmstrom · G. · Larsson · E. · Gränse · L. · Saric · M. · Sunnqvist · B. · Smith · L. · Hard · A.-L. · Morsing · E. · Lundgren · P.
Objectives

To retrospectively evaluate ophthalmological and neurological outcomes in a Swedish cohort of infants born before 24 weeks gestational age (GA) and explore risk factors for visual impairment.

Setting

Eye and paediatric clinics in Sweden.

Participants

Infants screened for retinopathy of prematurity (ROP) (n=399), born before 24 weeks GA, 2007–2018. Cases were excluded if ophthalmological follow-up records could not be traced.

Primary and secondary outcome measures

Primary outcomes were ophthalmological, including visual acuity (VA), refractive error, strabismus, nystagmus and cerebral visual impairment (CVI). Secondary outcomes comprised neonatal and neurological morbidities. Data were retrospectively retrieved from medical records.

Results

The 355 assessed children had a median GA of 23 weeks and 2 days and a median birth weight of 565 g. At the last available ophthalmological examination, the median age was 4.8 years (range 0.5–13.2 years). Nystagmus was recorded in 21.1%, strabismus in 34.8%, and 51.0% wore spectacles. Seventy-three of 333 (21.9%) were visually impaired, defined as being referred to a low vision clinic and/or having a VA less than 20/60 at 3.5 years of age or older. ROP treatment was a significant risk factor for visual impairment (OR 2.244, p=0.003). Visually impaired children, compared with children without visual impairment, more often had neurological deficits such as intellectual disability 63.8% versus 33.3% (p

Conclusions

Children born before 24 weeks GA frequently had visual impairment in association with neurological deficits. CVI was rarely diagnosed. A multidisciplinary approach for the evaluation and habilitation of these vulnerable infants is warranted. National follow-up guidelines need to be developed and implemented.

Existing barriers and recommendations of real-world data standardisation for clinical research in China: a qualitative study

Por: Lai · J. · Liao · X. · Yao · C. · Jin · F. · Wang · B. · Li · C. · Zhang · J. · Liu · L.
Objective

To investigate the existing barriers and recommendations of real-world data (RWD) standardisation for clinical research through a qualitative study on different stakeholders.

Design

This qualitative study involved five types of stakeholders based on five interview outlines. The data analysis was performed using the constructivist grounded theory analysis process.

Setting

Eight hospitals, four hospital system vendors, three big data companies, six medical products companies and four regulatory institutions were included.

Participants

In total, 62 participants from 25 institutions were interviewed through purposive sampling.

Results

The findings showed that the lack of clinical applicability in existing terminology standards, lack of generalisability in existing research databases, and lack of transparency in existing data standardisation process were the barriers of data standardisation of RWD for clinical research. Enhancing terminology standards by incorporating locally used clinical terminology, reducing burden in the usage of terminology standards, improving generalisability of RWD for research by using clinical data models, and improving traceability to source data for transparency might be feasible suggestions for solving the current problems.

Conclusions

Efficient and reliable data standardisation of RWD for clinical research can help generate better evidence used to support regulatory evaluation of medical products. This research suggested enhancing terminology standards by incorporating locally used clinical terminology, reducing burden in the usage of terminology standards, improving generalisability of RWD for research by using clinical data models, and improving traceability to source data for transparency to guide efforts in data standardisation in the future.

Factors associated with discontinuation among long-acting reversible contraceptive users: a multisite prospective cohort study in urban public health facilities in Ethiopia

Por: Mihretie · G. S. · Abebe · S. M. · Abebaw · Y. · Gedefa · L. · Gure · T. · Alemayehu · B. A. · Amenu · D. · Tadesse · D. · Fanta · G. A. · Abubeker · F. A. · Yemane · A. · G/Michael · A. D. · Teklu · A. M. · Damtew · M. H. · Girma · B.
Objective

The study aims to determine discontinuation among long-acting reversible contraceptive users at 3, 6, 9 and 12 months after initiation and its associated factors among new long-acting reversible contraceptive (LARC) users.

Design

A facility-based multicentre prospective cohort study was conducted with a sample size of 1766 women.

Setting

The study was conducted in five large cities of Ethiopia (Addis Ababa, Gondar, Mekelle, Jimma and Harar) between March 2017 and December 2018. Various referral hospitals and health centres that are found in those cities are included in the study.

Participants

The study population was all women who were new users of LARCs and initiated LARCs in our selected public health facilities during the enrolment period.

Interventions

A pretested structured questionnaire was administered at enrolment and at 6 and 12 months to determine discontinuation proportion and factors associated with discontinuation.

Result

From the total of 1766 women sampled for the study only 1596 (90.4%) participants completed all the questionnaires including the 12-month follow-up study. The overall proportion of discontinuation of LARCs at 12 months was 21.8% (95% CI 19.8 to 23.9). The overall discontinuation proportions at 3, 6, 9 and 12 months were 2.94%, 8.53%, 3.94% and 6.36%, respectively. Location of method initiation (adjusted HR (aHR)=5.77; (95% CI 1.16 to 28.69)) and dissatisfaction with the method (aHR=0.09; (95% CI 0.03 to 0.21)) were found to be the predictors of discontinuation among intrauterine contraceptive device users. Being satisfied with the method (aHR=0.21; (95% CI 0.15 to 0.27)), initiation after post abortion (aHR=0.48; (95% CI: 0.26, 0.89)) and joint decision with partner for method initiation (aHR=0.67; (95% CI: 0.50, 0.90)) were inversely associated with implant discontinuation.

Conclusion

The majority of LARC users discontinue the method in the first 6 months after insertion and dissatisfaction with the method increased the likelihood of removal during the first year of LARC use.

Cross-sectional associations between physical activity pattern, sports participation, screen time and mental health in Swedish adolescents

Por: Kjellenberg · K. · Ekblom · O. · Ahlen · J. · Helgadottir · B. · Nyberg · G.
Objectives

To investigate the associations between physical activity pattern, sports participation, screen time and mental health in Swedish adolescents.

Design, setting and participants

A total of 1139 Swedish adolescents (mean age 13.4) from 34 schools participated in the cross-sectional study ‘Physical Activity for Healthy Brain Functions in School Youth’ in 2019.

Methods

Time spent sedentary and in moderate-to-vigorous physical activity (MVPA) was measured using accelerometers for seven consecutive days. Screen time and sports participation were self-reported. Anxiety and health-related quality of life (HRQoL) were assessed using a Short version of the Spence Children’s Anxiety Scale and Kidscreen-10.

Results

MVPA was positively associated (95% CI 0.01 to 0.05 in girls and 0.02 to 0.07 in boys) whereas screen time on weekdays was inversely associated with HRQoL (–4.79 to –2.22 in girls and –2.66 to –0.41 in boys). The largest effect sizes were observed between the high/low MVPA group in boys (Cohen’s d=0.51) and screen time groups in girls (Cohen’s d=0.59 on weekdays). With regards to anxiety, high compared with lower time spent in MVPA during leisure time on weekdays was associated with lower anxiety scores (95% CI –0.13 to –0.05 in girls and –0.07 to –0.01 in boys). Gender differences were observed, boys who participated in organised sports had low anxiety scores (95% CI –3.49 to –0.13) whereas girls who reported 5 hours or more of screen time had high scores (95% CI 1.94 to 6.18 on weekdays and 1.39 to 5.29 on weekend days).

Conclusions

This study showed that MVPA was associated with better mental health, whereas the opposite was seen for screen time. These associations were not consistently significant throughout all time domains, between the genders and mental health outcomes. Our results could create a paradigm for future studies to decide which types of PA patterns and time domains to target in intervention studies with the aim improve mental health among adolescents.

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