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Long-term effectiveness of rehabilitation services delivery for Wenchuan earthquake survivors with impairments over a 4-year period: a prospective cohort study

Por: Reinhardt · J. · Zhang · X. · Chen · S. · Li · J. · Zhou · M. · Khan · F.
Objective

To examine long-term effectiveness of rehabilitation services on physical function, pain severity and post-traumatic stress disorder (PTSD) in earthquake survivors over a 4-year period.

Design

Prospective cohort study with early and late intervention and geographical control group.

Setting

Three counties of Sichuan Province, China.

Participants

591 survivors of the 2008 Wenchuan earthquake were followed-up over a 4-year period ranging from 2008 to 2012.

Interventions

In Mianzhu county, a comprehensive hospital-based and community-based rehabilitation programme was implemented in September 2008; in Anxian county, the same programme was implemented 1 year later; in Shifang county, the programme was not implemented and survivors from this county served as a control group.

Outcomes

Physical function was measured using Modified Barthel Index (MBI), pain severity with Visual Analogue Scale and PTSD with the PTSD Checklist-Civilian Version. All outcomes were assessed at three time points (baseline from 2008 to 2009, 2010 and 2012) and analysed with mixed effects regression.

Results

400 patients completed all assessments. In all groups, physical function and pain severity improved over time. MBI improvement per month as compared with control was greater in the late rehabilitation (b=1.69, 95% CI 1.20 to 2.19) than the early rehabilitation group (b=0.96, 95% CI 0.68 to 1.24). This rehabilitation effect was however marginally decreasing over time. Superior improvement as compared with control with regard to pain was only found in the early rehabilitation group (b=–0.05, 95% CI –0.09 to –0.02). PTSD symptoms decreased over time, but the observed differences could not be specifically linked to the rehabilitation intervention.

Conclusion

Physical rehabilitation of earthquake survivors appears to be effective in improving physical function and, if delivered early, pain. Effects on mental health are less clear and need further examination using more consistent and frequent assessments of relevant outcomes and determinants.

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.

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.

Prognostic associations of ECG tracings in hospitalised patients with COVID-19: a systematic review and meta-analysis protocol

Por: Interior · J. S. · Garcia · J. G. · Yu · G. S. G. · Regencia · Z. J. G. · Baja · E. S. · Ligsay · A. D. · Gerodias · F. R.
Introduction

COVID-19 is a global pandemic caused by the SARS-CoV-2 virus. Although most COVID-19 cases are asymptomatic or mild, a significant number of patients experienced adverse outcomes. In addition, studies have shown that cardiac abnormalities are associated with increased mortality in hospitalised patients with COVID-19. This finding sets a precedent for the potential use of ECG tracing as an indicator of patient mortality and morbidity. This study aims to determine associations between the 12-lead ECG findings and various clinical outcomes of hospitalised patients with COVID-19, measured as incidence of endotracheal intubation, intensive care unit (ICU) admission and mortality rate.

Methods and analysis

An electronic literature search will identify all potentially relevant articles using specific databases and websites. The search will be limited to studies published from December 2019 to May 2021. In addition, studies will include hospitalised patients with COVID-19 with normal and abnormal 12-lead ECG findings assessed for clinical outcomes, including the incidence of endotracheal intubation, ICU admission and mortality rate. The risk of bias in individual studies will be evaluated using the Quality in Prognostic Studies tool or the Cochrane risk of bias tool. A meta-analysis will be conducted if at least two studies indicate a prognostic factor’s effect. Moreover, subgroup and sensitivity analyses will be performed accordingly to address heterogeneity. Reporting the review results will comply with the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. The quality of evidence generated will be assessed using the Grades of Recommendation, Assessment, Development and Evaluation system.

Ethics and dissemination

This study has been exempted from ethics review. There will be no patient or public involvement in this study. Furthermore, the findings will be disseminated via conferences, seminars, symposia and congresses on top of peer-reviewed journals.

PROSPERO registration number

CRD42021257155.

Decision aids for home and community care: a systematic review

Por: Lognon · T. · Plourde · K. V. · Aubin · E. · Giguere · A. M. C. · Archambault · P. M. · Stacey · D. · Legare · F.
Objectives

Decision aids (DAs) for clients in home and community care can support shared decision-making (SDM) with patients, healthcare teams and informal caregivers. We aimed to identify DAs developed for home and community care, verify their adherence to international DA criteria and explore the involvement of interprofessional teams in their development and use.

Design

Systematic review reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

Six electronic bibliographic databases (MEDLINE, Embase, CINAHL Plus, Web of Science, PsycINFO and the Cochrane Library) from inception to November 2019, social media and grey literature websites up to January 2021.

Eligibility criteria

DAs designed for home and community care settings or including home care or community services as options.

Data extraction and synthesis

Two reviewers independently reviewed citations. Analysis consisted of a narrative synthesis of outcomes and a thematic analysis. DAs were appraised using the International Patient Decision Aid Standards (IPDAS). We collected information on the involvement of interprofessional teams, including nurses, in their development and use.

Results

After reviewing 10 337 database citations and 924 grey literature citations, we extracted characteristics of 33 included DAs. DAs addressed a variety of decision points. Nearly half (42%) were relevant to older adults. Several DAs did not meet IPDAS criteria. Involvement of nurses and interprofessional teams in the development and use of DAs was minimal (33.3% of DAs).

Conclusion

DAs concerned a variety of decisions, especially those related to older people. This reflects the complexity of decisions and need for better support in this sector. There is little evidence about the involvement of interprofessional teams in the development and use of DAs in home and community care settings. An interprofessional approach to designing DAs for home care could facilitate SDM with people being cared for by teams.

PROSPERO registration number

CRD42020169450.

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.

Clinical performance of the Roche Cobas 4800 HPV test for primary cervical cancer screening in a Chinese population

by Stephanie S. Liu, Karen K. L. Chan, Tina N. Wei, Ka Yu Tse, Siew F. Ngu, Mandy M. Y. Chu, Lesley S. K. Lau, Annie N. Y. Cheung, Hextan Y. S. Ngan

High-risk human papillomavirus (HR-HPV) testing has become an increasing important strategy in primary cervical cancer screening in recent years. It warrants the evaluation of molecular-based HPV tests for accuracy and efficacy of screening. The performance of Roche Cobas 4800 HPV test was validated and compared with Digene Hybrid Capture 2 (HC2) high-risk HPV DNA test for primary screening in a large Chinese screening cohort. Of 6345 women screened, overall agreement between Cobas and HC2 was 92.23% (95% CI: 91.57–92.89). The inter-assay agreement was correlated with the severity of underlying biology, with an increasing concordance found in samples with more severe abnormalities. Most of the discordant samples had the test signal strength closer to the test limits of the detection than concordant samples, reflecting a low viral load and infection of a cluster of low-risk HPV in these samples. The Cobas test demonstrated significantly higher specificity in identifying CIN2+/CIN3+ cases than HC2 test (66.46% vs 43.67% and 65.42% vs 42.86%, p

Novel device for assisted vaginal birth: using integrated qualitative case study methodology to optimise Odon Device use within a feasibility study in a maternity unit in the Southwest of England

Por: Hotton · E. J. · Blencowe · N. S. · Bale · N. · Lenguerrand · E. · Draycott · T. J. · Crofts · J. F. · Wade · J.
Objective

When novel devices are used ‘in human’ for the first time, their optimal use is uncertain because clinicians only have experience from preclinical studies. This study aimed to investigate factors that might optimise use of the Odon Device for assisted vaginal birth.

Design

We undertook qualitative case studies within the ASSIST Study, a feasibility study of the Odon Device. Each ‘case’ was defined as one use of the device and included at least one of the following: observation of the attempted assisted birth, and an interview with the obstetrician, midwife or woman. Data collection and thematic analysis ran iteratively and in parallel.

Setting

Tertiary referral National Health Service maternity unit in the Southwest of England.

Participants

Women requiring a clinically indicated assisted vaginal birth.

Intervention

The Odon Device, an innovative device for assisted vaginal birth.

Primary and secondary outcome measures

Determining the optimal device technique, device design and defining clinical parameters for use.

Results

Thirty-nine cases involving an attempted Odon-assisted birth were included in this study, of which 19 resulted in a successful birth with the device. Factors that improved use included optimisation of device technique, device design and clinical parameters for use. Technique adaptations included: applying the device during, rather than between, contractions; having a flexible approach to the application angle; and deflating the air cuff sooner than originally proposed. Three design modifications were proposed involving the deflation button and sleeve. Although use of the device was found to be appropriate in all fetal positions, it was considered contraindicated when the fetal station was at the ischial spines.

Conclusions

Case study methodology facilitated the acquisition of rapid insights into device function in clinical practice, providing key insights regarding use, design and key clinical parameters for success. This methodology should be considered whenever innovative devices are introduced into clinical practice.

Trial registration number

ISRCTN10203171.

Are psychosocial variables, sleep characteristics or central pain processing prognostic factors for outcome following rotator cuff repair? A protocol for a prospective longitudinal cohort study

Por: Schwank · A. · Struyf · T. · Struyf · F. · Blazey · P. · Mertens · M. · Gisi · D. · Pisan · M. · Meeus · M.
Introduction

Prognosis following surgical rotator cuff repair (RCR) is often established through the assessment of non-modifiable biomedical factors such as tear size. This understates the complex nature of recovery following RCR. There is a need to identify modifiable psychosocial and sleep-related variables, and to find out whether changes in central pain processing influence prognosis after RCR. This will improve our knowledge on how to optimise recovery, using a holistic rehabilitation approach.

Methods and analysis

This longitudinal study will analyse 141 participants undergoing usual care for first time RCR. Data will be collected 1–21 days preoperatively (T1), then 11–14 weeks (T2) and 12–14 months (T3) postoperatively. We will use mixed-effects linear regression to assess relationships between potential prognostic factors and our primary and secondary outcome measures—the Western Ontario Rotator Cuff Index; the Constant-Murley Score; the Subjective Shoulder Value; Maximal Pain (Numeric Rating Scale); and Quality of Life (European Quality of Life, 5 dimensions, 5 levels). Potential prognostic factors include: four psychosocial variables; pain catastrophising, perceived stress, injury perceptions and patients’ expectations for RCR; sleep; and four factors related to central pain processing (central sensitisation inventory, temporal summation, cold hyperalgesia and pressure pain threshold). Intercorrelations will be assessed to determine the strength of relationships between all potential prognostic indicators.

Our aim is to explore whether modifiable psychosocial factors, sleep-related variables and altered central pain processing are associated with outcomes pre-RCR and post-RCR and to identify them as potential prognostic factors.

Ethics and dissemination

The results of the study will be disseminated at conferences such as the European Pain Congress. One or more manuscripts will be published in a peer-reviewed SCI-ranked journal. Findings will be reported in accordance with the STROBE statement and PROGRESS framework. Ethical approval is granted by the Ethical commission of Canton of Zurich, Switzerland, No: ID_2018-02089

Trial registration number

NCT04946149.

Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment: study protocol for a pragmatic cluster randomised controlled trial (GET Sleep)

Por: Spiegelhalder · K. · Baumeister · H. · Al-Kamaly · A. · Bader · M. · Bauereiss · N. · Benz · F. · Braun · L. · Buntrock · C. · Burkhardt · M. · Cuijpers · P. · Domschke · K. · Dülsen · P. · Franke · M. · Frase · L. · Heber · E. · Helm · K. · Jentsch · T. · Johann · A. · Küchler · A.-M.
Introduction

It is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I.

Methods and analysis

In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the Medical Centre—University of Freiburg. The results of the study will be published irrespective of the outcome.

Trial registration number

DRKS00021503.

DNA Methylation Analysis to predict Regression of high-grade anal Intraepithelial Neoplasia in HIV+ men (MARINE): a cohort study protocol

Introduction

Anal cancer precursors, or high-grade anal intraepithelial neoplasia (HGAIN), are highly prevalent in HIV-seropositive (HIV+) men who have sex with men (MSM). Around 30% of lesions regress within 1 year, but current histopathological assessment is unable to distinguish between HGAIN likely to regress and HGAIN likely to persist or progress to cancer. We aim to assess if host cell DNA methylation markers can predict regression of HGAIN, thus determining the need for immediate treatment or active surveillance. This could reduce overtreatment and the associated anal and psycho-sexual morbidity.

Methods and analysis

This is an active surveillance cohort study in three centres located in Amsterdam, the Netherlands, in 200 HIV+ MSM diagnosed with HGAIN. Participants will not be treated, but closely monitored during 24 months of follow-up with 6 monthly visits including cytology, and high-resolution anoscopy with biopsies. The primary study endpoint is histopathological regression of each baseline HGAIN lesion at the end of the study. Regression is defined as ≤low grade anal intraepithelial neoplasia in the exit biopsy at 24 months. Regression proportions in lesions with low versus high methylation levels (ASCL1, ZNF582), other biomarkers (HPV genotype, HPV-E4, p16INK4A, Ki-67) and immunological markers at baseline will be compared. Main secondary endpoints are the histological and clinical outcome (ie, the number of octants affected by HGAIN) of each baseline HGAIN lesion and overall HGAIN disease (i.e., all lesions combined) after each visit. The health-related quality of life of the study group will be compared with that of a control group of 50 HIV+ MSM receiving regular HGAIN treatment.

Ethics and dissemination

Ethics approval was obtained from the Institutional Review Board of the Academic Medical Center (Amsterdam, The Netherlands; reference no. 2021_099). Participants are required to provide written informed consent. Findings will be disseminated through publication in peer-reviewed scientific journals and presentations at international scientific conferences; dissemination to policy makers and the target patient group will be achieved through our (inter-)national network, professional associations and collaboration with a patient representative organisation.

Trial registration number

NL9664.

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.

Enhanced womens decision-making power after the Suchana intervention in north-eastern Bangladesh: a cluster randomised pre-post study

Por: Haque · M. A. · Choudhury · N. · Ahmed · S. M. T. · Farzana · F. D. · Ali · M. · Naz · F. · Siddiqua · T. J. · Raihan · M. J. · Rahman · S. S. · Faruque · A. S. G. · Ahmed · T.
Objectives

Women’s decision-making power is a dimension of empowerment and is crucial for better physical and psychosocial outcomes of mothers. Suchana, a large-scale development programme in Bangladesh, actively provided social interventions on behaviour change communication to empower women belonging to the poorest social segment. This paper aims to assess the impact of the Suchana intervention on various indicators related to women’s decision-making power.

Design, setting and participants

The evaluation design was a cluster randomised pre-post design with two cross-sectional surveys conducted among beneficiary women with at least one child aged

Outcome measure

Decision-making indicators included food purchases, major household purchases, food preparation, children’s healthcare as well as women’s own healthcare and visiting family and relatives.

Results

Our findings suggest that 45% of women were able to make decisions on food purchases, 25% on major household purchases, 78% on food preparation, 59% on children’s healthcare, 51% on their own healthcare and 43% on visiting family and relatives at baseline in the intervention group, whereas the results were almost the same in the control group. In contrast, at the endline survey, the respective proportions were 75%, 56%, 87%, 80%, 77% and 67% in the intervention group, which were significantly improved when compared with the control group. The prevalence of those outcome indicators were 64%, 41%, 80%, 71%, 68% and 56%, respectively, in the control group. As per multiple logistic regression analysis and structural equation modelling, the Suchana intervention had a substantial influence on the latent variable of women’s decision-making power.

Conclusion

In terms of food purchases, major household purchases, children’s healthcare, their own healthcare and visiting family and relatives, the Suchana intervention favourably influenced the decision-making power of rural women living in a vulnerable region of Bangladesh.

Trial registration number

RIDIE-STUDY-ID-5d5678361809b.

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.

Prevalence and heart rate variability characteristics of premature ventricular contractions detected by 24-hour Holter among outpatients with palpitations in China: a cross-sectional study

Por: Dong · Y. · Li · X. · Zheng · W. · Man · Y. · Liu · J. · Yu · P. · Zhang · F. · Yang · B. · Cao · K.
Objective

To analyse the prevalence and heart rate variability (HRV) characteristics of premature ventricular contraction (PVC) detected by 24-hour Holter among Chinese outpatients with palpitations.

Design

A cross-sectional study.

Setting

This study was conducted in a tertiary hospital.

Participants

A total of 4754 outpatients who received 24-hour Holter for palpitations.

Main outcome measures

Prevalence, HRV time-domain and frequency-domain analyses of 24-hour Holter, and echocardiographic parameters were assessed. Propensity score matching (PSM) was applied to balance baseline variables (age, gender) to decrease the bias between comparison groups.

Results

The prevalence of PVC was 67.7% (3220/4754), and was higher in men than women (69.9% vs 66.0%, p=0.004); the prevalence of frequent PVCs (PVC burden≥5%) was 7.7% (368/4754). Older patients had the highest frequency of PVC among all patients. However, among 3220 patients with PVC, younger patients’ PVC burden was much higher. Matched 1:1 by age and gender, the HRV time-domain parameters in patients with PVC were all lower than those in patients without PVC (all p

Conclusions

The prevalence of PVC and frequent PVCs were 67.7% and 7.7%, respectively, detected by 24-hour Holter among Chinese outpatients with palpitations. Decreased HRV time-domain parameters suggested the occurrence of PVC, and increased LF/HF ratio represented the imbalance of autonomic nervous system in patients with frequent PVCs. Further studies are needed to understand the HRV indexes in PVC patients.

What promotes or prevents greater use of appropriate compression in people with venous leg ulcers? A qualitative interview study with nurses in the north of England using the Theoretical Domains Framework

Por: Perry · C. · Atkinson · R. A. · Griffiths · J. · Wilson · P. M. · Lavallee · J. F. · Mullings · J. · Cullum · N. · Dumville · J. C.
Objectives

To investigate factors that promote and prevent the use of compression therapy in people with venous leg ulcers.

Design

Qualitative interview study with nurses using the Theoretical Domains Framework (TDF).

Setting

Three National Health Service Trusts in England.

Participants

Purposive sample of 15 nurses delivering wound care.

Results

Nurses described factors which made provision of compression therapy challenging. Organisational barriers (TDF domains environmental context and resources/knowledge, skills/behavioural regulation) included heavy/increasing caseloads; lack of knowledge/skills and the provision of training; and prescribing issues (variations in bandaging systems/whether nurses could prescribe). Absence of specialist leg ulcer services to refer patients into was perceived as a barrier to providing optimal care by some community-based nurses. Compression use was perceived to be facilitated by clinics for timely initial assessment; continuity of staff and good liaison between vascular/leg ulcer clinics and community teams; clear local policies and care pathways; and opportunities for training such as ‘shadowing’ in vascular/leg ulcer clinics. Patient engagement barriers (TDF domains goals/beliefs about consequences) focused on getting patients ‘on board’ with compression, and supporting them in using it. Clear explanations were seen as key in promoting compression use.

Conclusions

Rising workload pressures present significant challenges to enhancing leg ulcer services. There may be opportunities to develop facilitated approaches to enable community nursing teams to make changes to practice, enhancing quality of patient care. The majority of venous leg ulcers could be managed in the community without referral to specialist community services if issues relating to workloads/skills/training are addressed. Barriers to promoting compression use could also be targeted, for example, through the development of clear patient information leaflets. While the patient engagement barriers may be easier/quicker to address than organisational barriers, unless organisational barriers are addressed it seems unlikely that all people who would benefit from compression therapy will receive it.

Lived experience of Jordanian front-line healthcare workers amid the COVID-19 pandemic: a qualitative study

Por: Nazzal · M. S. · Oteir · A. O. · Jaber · A. F. · Alwidyan · M. T. · Raffee · L.
Objectives

This study aimed to explore the lived experience of Jordanian front-line healthcare workers (FHCWs), including their experienced challenges and adaptations amid the COVID-19 pandemic.

Design

A phenomenological qualitative design was used to highlight the experiences of a sample Jordanian FHCWs during the COVID-19 pandemic. Qualitative interviews were conducted using a semistructured guide with open-ended questions, audiotaped and then transcribed verbatim. Thematic analysis of the transcribed narratives was conducted using an open coding line by line to develop themes and related subthemes.

Setting

Mobile COVID-19 testing and contact tracing units during an active surge of cases in Jordan between May and September 2020.

Participants

Participants were recruited using purposive sampling method and consisted of 15 FHCWs (2 physicians, 10 nurses, 2 paramedics and 1 laboratory technician) who have worked in testing and contact tracing teams in the community and have dealt with suspected or confirmed cases of COVID-19 infection.

Results

Participant narratives were classified into two main overarching themes; challenges and adaptation themes. The challenges theme was exhibited as follows: (1) an excruciating encounter with an invisible enemy, (2) distorted knowledge about COVID-19 and (3) organisational and administrative challenges. The adaptation theme was exhibited as follows: (1) seeking relevant knowledge about the disease and (2) seeking more connectedness.

Conclusions

The COVID-19 pandemic exerted many challenges for FHCWs at multiple levels; intrapersonal and interpersonal, organisational and societal levels. Nevertheless, a number of adaptation strategies within these levels have been reported. This study helps to provide the base on which healthcare officials and public health personnel can formulate preparedness plans that tackle challenges faced by front-line workers, which ultimately enhance the resilience of healthcare systems to withstand future pandemics.

Strongyloides stercoralis prevalence in solid-organ and haematopoietic stem cell transplant candidates and recipients: a systematic review and meta-analysis protocol

Por: Barkati · S. · Naeem · F. · Hales · L. · Quan · C. · Libman · M.
Introduction

Strongyloides stercoralis is an intestinal helminth ubiquitous in tropical and subtropical regions worldwide. It persists in the human host for a lifetime as a result of autoinfection and if undetected and untreated, can lead to increased morbidity and high mortality in immunocompromised individuals such as the transplant population. Transplant patients, including solid-organ and haematopoietic stem cell transplants (SOT and HSCT, respectively), are at a high risk of hyperinfection and disseminated strongyloidiasis. Unfortunately screening is often not systematically performed. Prevalence estimates of Strongyloides in this high-risk population is not well studied. Through this systematic review, we aim to summarise the descriptive evidence on Strongyloides prevalence in SOT and HSCT patients, including diagnostic and screening practices alongside the cases of hyperinfection, disseminated strongyloidiasis and the mortality rate in this population.

Methods and analyses

Through the use of various online library databases, we will conduct a systematic review including relevant literature on the prevalence of Strongyloides in SOT and HSCT patients as well as studies assessing hyperinfection and disseminated strongyloidiasis in this patient population. The Population, Intervention, Comparison, Outcome and Study Design strategy and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be used to determine a final subset of studies for analysis. Quality assessment for case series and case reports will be determined by a modified quality assessment tool developed by the National Heart, Lung, and Blood Institute (NIH), and the CARE guidelines, respectively. We will provide a narrative synthesis of the findings pertaining to the primary and secondary outcomes of interest (prevalence of Strongyloides and mortality rate in transplant population, respectively) alongside the associated 95% CI. Estimates from individual studies will be pooled using a random effects model.

Ethics and dissemination

This systematic review does not require formal ethical approval since no primary data will be collected. Findings will be disseminated through a peer-reviewed publication and relevant conferences.

PROSPERO registration number

CRD42021269305.

Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery in colorectal carcinoma at high risk of peritoneal carcinomatosis: short-term and long-term outcomes from the CHECK study - protocol for a randomised,

Por: Pacelli · F. · Gerardi · C. · Rulli · E. · Abatini · C. · Rotolo · S. · Garattini · S. · Melotti · G. · Torri · V. · Galli · F. · Rulli · E. · Di Giorgio · A. · On behalf of CHECK Investigators
Introduction

Up to one-fifth of patients with colorectal cancer will develop peritoneal metastases, frequently without other districts’ involvement. Despite the recent unsuccesses of hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer peritoneal metastases treatment, the rationale in the prophylactic setting remains strong. Several clinical and pharmacokinetic data suggest that the efficacy of intraperitoneal chemotherapy is highest when the disease is microscopic. However, robust evidence demonstrating whether the addition of HIPEC for high-risk colorectal cancers offers better control of local recurrence is lacking.

Methods and analysis

This is a multicentre randomised phase 3 trial comparing prophylactic surgery plus HIPEC CO2 with mitomycin, over standard surgical excision in patients with colorectal cancer at high risk of peritoneal carcinomatosis; 388 patients will be included in this study. The primary objective is to compare the efficacy of prophylactic surgery (radical colorectal resection, omentectomy, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 with mitomycin and standard surgery in terms of local recurrence-free survival. The main secondary endpoints are disease-free survival (DFS), overall survival (OS) and safety. The primary endpoint will be described with a cumulative incidence function and will be analysed with Grey test to take account of the competing risks. DFS and OS will be described with the Kaplan-Meier method.

Ethics and dissemination

This trial has been evaluated by the Italian Medicines Agency, local ethics committees and will be submitted to the Ministry of Health to notify the start of the trial according to the regulation of trials on devices with CE mark/certification.

The results will be submitted for presentation at academic meetings and for publication in a peer-reviewed journal, whatever the findings.

Trial registration number

NCT03914820.

Resilience and intention of healthcare workers in China to receive a COVID‐19 vaccination: The mediating role of life satisfaction and stigma

Abstract

Aims

The present study investigated the association between resilience, stigma, life satisfaction and the intention to receive a COVID-19 vaccination among Chinese HCWs. It also explored the mediating role of stigma and life satisfaction on the association between resilience and intention to receive a COVID-19 vaccination.

Design

An anonymous cross-sectional survey.

Methods

1733 HCWs from five hospitals in four provinces of mainland China completed a cross-sectional online survey in October and November 2020.

Results

Among the HCWs, the rate of intention to receive a COVID-19 vaccination was 73.1%. Results from structural equation modelling showed that resilience was associated both directly, and indirectly with greater intent to receive a COVID-19 vaccination through two pathways: first by increasing life satisfaction, and second by reducing stigma and increasing life satisfaction.

Conclusion

Promoting the resilience of HCWs has the potential to increase the COVID-19 vaccination uptake rate among HCWs in China.

Impact

This study tested the relationship between several psychological factors and the COVID-19 vaccination intention of HCWs in China, finding that resilience played a significant role in improving COVID-19 vaccination intention rates by reducing stigma and increasing life satisfaction.

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