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AnteayerBMJ Open

Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)

Por: Thapar · A. · Lawton · R. · Burgess · L. · Shalhoub · J. · Bradbury · A. · Cullum · N. · Epstein · D. · Gohel · M. · Horne · R. · Hunt · B. J. · Norrie · J. · Davies · A. H.
Introduction

Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT.

Methods and analysis

Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23–32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective.

Ethics and dissemination

UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences.

Trial registration number

ISRCTN registration number 73041168.

UK Chiari 1 Study: protocol for a prospective, observational, multicentre study

Introduction

Chiari 1 malformation (CM1) is a structural abnormality of the hindbrain characterised by the descent of the cerebellar tonsils through the foramen magnum. The management of patients with CM1 remains contentious since there are currently no UK or international guidelines for clinicians. We therefore propose a collaborative, prospective, multicentre study on the investigation, management and outcome of CM1 in the UK: the UK Chiari 1 Study (UKC1S). Our primary objective is to determine the health-related quality of life (HRQoL) in patients with a new diagnosis of CM1 managed either conservatively or surgically at 12 months of follow-up. We also aim to: (A) determine HRQoL 12 months following surgery; (B) measure complications 12 months following surgery; (C) determine the natural history of patients with CM1 treated conservatively without surgery; (D) determine the radiological correlates of presenting symptoms, signs and outcomes; and (E) determine the scope and variation within UK practice in referral patterns, patient pathways, investigations and surgical decisions.

Methods and analysis

The UKC1S will be a prospective, multicentre and observational study that will follow the British Neurosurgical Trainee Research Collaborative model of collaborative research. Patients will be recruited after attending their first neurosurgical outpatient clinic appointment. Follow-up data will be collected from all patients at 12 months from baseline regardless of whether they are treated surgically or not. A further 12-month postoperative follow-up timepoint will be added for patients treated with decompressive surgery. The study is expected to last three years.

Ethics and dissemination

The UKC1S received a favourable ethical opinion from the East Midlands Leicester South Research Ethics Committee (REC reference: 20/EM/0053; IRAS 269739) and the Health Research Authority. The results of the study will be published in peer-reviewed medical journals, presented at scientific conferences, shared with collaborating sites and shared with participant patients if they so wish.

Policy changes and the screening, diagnosis and treatment of drug-resistant tuberculosis patients from 2015 to 2018 in Zhejiang Province, China: a retrospective cohort study

Por: Jiang · W. · Peng · Y. · Wang · X. · Elbers · C. · Tang · S. · Huang · F. · Chen · B. · Cobelens · F.
Objectives

To examine changes in the screening, diagnosis, treatment and management of drug-resistant tuberculosis (DRTB) patients, and investigate the impacts of DRTB-related policies on patients of different demographic and socioeconomic characteristics.

Design

A retrospective cohort study using registry data, plus a survey on DRTB-related policies.

Setting

All prefecture-level Centres for Disease Control in Zhejiang Province, China.

Main outcome measures

Alongside the care cascade, we examined: (1) reported number of presumptive DRTB patients; (2) percentage of presumptive patients with drug susceptibility testing (DST) records; (3) percentage of DRTB/rifampicin-resistant (RR) patients registered; (4) percentage of RR/multidrug-resistant TB (MDRTB) patients that received anti-DRTB treatment; and (5) percentage of RR/MDRTB patients cured/completed treatment among those treated. Multivariate logistic regressions were conducted to explore the impacts of DRTB policies after adjusting for other factors.

Results

The number of reported presumptive DRTB patients and the percentage with DST records largely increased during 2015–2018, and the percentage of registered patients who received anti-DRTB treatment also increased from 59.0% to 86.5%. Patients under the policies of equipping GeneXpert plus expanded criteria for DST had a higher likelihood of being registered compared with no GeneXpert (adjusted OR (aOR)=2.57, 95% CI: 1.20 to 5.51), while for treatment initiation the association was only significant when further expanding the registration criteria (aOR=2.38, 95% CI: 1.19 to 4.79). Patients with registered residence inside Zhejiang were more likely to be registered (aOR=1.96, 95% CI: 1.52 to 2.52), treated (aOR=3.83, 95% CI: 2.78 to 5.28) and complete treatment (aOR=1.92, 95% CI: 1.03 to 3.59) compared with those outside.

Conclusion

The policy changes on DST and registration have effectively improved DRTB case finding and care. Nevertheless, challenges remain in servicing vulnerable groups such as migrants and improving equity in the access to TB care. Future policies should provide comprehensive support for migrants to complete treatment at their current place of residence.

Multivariate analysis of the impact of weather and air pollution on emergency department visits for night-time headaches among children: retrospective, clinical observational study

Por: Yamaguchi · H. · Nozu · K. · Ishiko · S. · Nagase · H. · Ninchoji · T. · Nagano · C. · Takeda · H. · Unzaki · A. · Ishibashi · K. · Morioka · I. · Iijima · K. · Ishida · A.
Objectives

To examine the association between the number of visits to the emergency department (ED) by children for night-time headaches and exposure to multifaceted factors, such as meteorological conditions and air pollution.

Design

We conducted a clinical observational time-series analysis study.

Setting

We reviewed consecutive patients younger than 16 years of age at the primary ED centre in Kobe city, Japan, during the night shift (19:30–7:00 hours) between 1 January 2011 and 31 December 2019.

Participants

In total, 265 191 children visited the ED; 822 presented with headache during the study period.

Primary outcome measures

We investigated the effects of meteorological factors and air pollutants by multivariate analysis of Poisson regression estimates. A subanalysis included the relationship between the number of patients with night-time headaches and the above factors by sex. Furthermore, the effect of typhoon landing on patient visits for headache was also analysed. Headache was not classified because examinations were performed by general paediatricians (non-specialists).

Results

The number of patients with night-time headaches displayed distinct seasonal changes, with peaks during the summer. Multivariate analysis of Poisson regression estimates revealed a significant positive relationship between the number of patients for headache and mean temperature. Subanalysis by sex indicated a positive relationship between the number of patients with headache and mean temperature in both sexes; however, it was significant only for females. No relationship was found between the number of patients with headache and air pollution. There was no change in the number of patients for night-time headaches 3 days before and after typhoon landing.

Conclusions

High temperature is the main factor for visiting ED for night-time headaches among children in Kobe city. Our results suggest that preventive measures against night-time headaches may be possible by reducing time spent outside during summer.

Knowledge, attitude and experience of episiotomy practice among obstetricians and midwives: a cross-sectional study from China

Por: Yang · J. · Bai · H.
Objective

Episiotomy is still performed widely by obstetricians and midwives in some Chinese maternity units, but the reasons are unknown. This study aims to determine the knowledge, attitude and experience towards the practice of episiotomy among obstetricians and midwives in China’s public hospitals and consider strategies to reduce its practice.

Methods

A cross-sectional web survey using a self-administered questionnaire was conducted among obstetricians and midwives in 90 public hospitals in Henan Province, China.

Results

900 (82.21%) participants completed the questionnaire. Average knowledge level (4.15, SD=1.10) on complications and overuse was identified among participants. Episiotomy was performed more frequently in secondary hospitals than in tertiary hospitals (p

Conclusion

In sum, episiotomy was driven by previous training, practitioners’ experience and local norms rather than the latest medical evidence. Clinicians in secondary hospitals and senior clinicians are key training targets. It is urgent to improve current clinical policies and surgical procedure guidelines for obstetricians and midwives regarding episiotomy.

Validation of breast cancer risk assessment tools on a French-Canadian population-based cohort

Por: Jantzen · R. · Payette · Y. · de Malliard · T. · Labbe · C. · Noisel · N. · Broët · P.
Objectives

Evaluate the accuracy of the Breast Cancer Risk Assessment Tool (BCRAT), International Breast Cancer Intervention Study risk evaluation tool (IBIS), Polygenic Risk Scores (PRS) and combined scores (BCRAT+PRS and IBIS +PRS) to predict the occurrence of invasive breast cancers at 5 years in a French-Canadian population.

Design

Population-based cohort study.

Setting

We used the population-based cohort CARTaGENE, composed of 43 037 Quebec residents aged between 40 and 69 years and broadly representative of the population recorded on the Quebec administrative health insurance registries.

Participants

10 200 women recruited in 2009–2010 were included for validating BCRAT and IBIS and 4555 with genetic information for validating the PRS and combined scores.

Outcome measures

We computed the absolute risks of breast cancer at 5 years using BCRAT, IBIS, four published PRS and combined models. We reported the overall calibration performance, goodness-of-fit test and discriminatory accuracy.

Results

131 (1.28%) women developed a breast cancer at 5 years for validating BCRAT and IBIS and 58 (1.27%) for validating PRS and combined scores. Median follow-up was 5 years. BCRAT and IBIS had an overall expected-to-observed ratio of 1.01 (0.85–1.19) and 1.02 (0.86–1.21) but with significant differences when partitioning by risk groups (p

Conclusions

In this French-Canadian population-based cohort, BCRAT and IBIS have good mean calibration that could be improved for risk subgroups, and modest discriminatory accuracy. Despite this modest discriminatory power, these tools can be of interest for primary care physicians for delivering a personalised message to their high-risk patients, regarding screening and lifestyle counselling.

Development of the Prevent for Work questionnaire (P4Wq) for assessment of musculoskeletal risk in the workplace: part 1--literature review and domains selection

Por: Langella · F. · Christensen · S. W. M. · Palsson · T. S. · Hogh · M. · Gagni · N. · Bellosta-Lopez · P. · Christiansen · D. H. · Delle Chiaie · M. · Domenech-Garcia · V. · Johnston · V. · Szeto · G. P. Y. · Villafane · J. H. · Herrero · P. · Berjano · P.
Objective

This study aims to define appropriate domains and items for the development of a self-administered questionnaire to assess the risk of developing work-related musculoskeletal disorder (WMSD) and the risk of its progression to chronicity.

Design

Literature review and survey study.

Setting and participants

A literature review and a two-round interview with 15 experts in musculoskeletal pain were performed to identify the available domains for WMSD assessment.

Interventions and outcome

To ensure quality, only validated questionnaires were included for the Delphi process. A three-round Delphi method, with three round steps, was used to select the most pertinent and relevant domains and items.

Results

Nine questionnaires were identified through the expert discussion and literature review, comprising 38 candidate domains and 504 items. In the first round of the Delphi group, 17 domains reached more than 70% agreement and were selected. In the second round, 10 domains were rejected, while 11 were selected to complete the pool of domains. In the third and final round, 89 items belonging to 28 domains were defined as significant to develop a WMSDs risk assessment questionnaire.

Conclusions

No specific risk assessment questionnaires for WMSDs were identified from the literature. WMSD risk of presence and chronicity can be defined by an assessment tool based on the biopsychosocial model and the fear-avoidance components of chronic pain. The present study provides the formulation and operationalisation of the constructs in domains and items needed for developing and validating the questionnaire.

Practitioners perceptions of acceptability of a question prompt list about palliative care for advance care planning with people living with dementia and their family caregivers: a mixed-methods evaluation study

Por: van der Steen · J. T. · Heck · S. · Juffermans · C. C. · Garvelink · M. M. · Achterberg · W. P. · Clayton · J. · Thompson · G. · Koopmans · R. T. · van der Linden · Y. M.
Objectives

In oncology and palliative care, patient question prompt lists (QPLs) with sample questions for patient and family increased patients’ involvement in decision-making and improved outcomes if physicians actively endorsed asking questions. Therefore, we aim to evaluate practitioners’ perceptions of acceptability and possible use of a QPL about palliative and end-of-life care in dementia.

Design

Mixed-methods evaluation study of a QPL developed with family caregivers and experts comprising a survey and interviews with practitioners.

Setting

Two academic medical training centres for primary and long-term care in the Netherlands.

Participants

Practitioners (n=66; 73% woman; mean of 21 (SD 11) years of experience) who were mostly general practitioners and elderly care physicians.

Outcomes

The main survey outcome was acceptability measured with a 15–75 acceptability scale with ≥45 meaning ‘acceptable’.

Results

The survey response rate was 21% (66 of 320 participated). The QPL was regarded as acceptable (mean 51, SD 10) but 64% felt it was too long. Thirty-five per cent would want training to be able to answer the questions. Those who felt unable to answer (31%) found the QPL less acceptable (mean 46 vs 54 for others; p=0.015). We identified three themes from nine interviews: (1) enhancing conversations through discussing difficult topics, (2) proactively engaging in end-of-life conversations and (3) possible implementation.

Conclusion

Acceptability of the QPL was adequate, but physicians feeling confident to be able to address questions about end-of-life care is crucial when implementing it in practice, and may require training. To facilitate discussions of advance care planning and palliative care, families and persons with dementia should also be empowered to access the QPL themselves.

Development of a core outcome set for congenital pulmonary airway malformations: study protocol of an international Delphi survey

Por: Hermelijn · S. · Kersten · C. · Mullassery · D. · Muthialu · N. · Cobanoglu · N. · Gartner · S. · Bagolan · P. · Mesas Burgos · C. · Sgro · A. · Heyman · S. · Till · H. · Suominen · J. · Schurink · M. · Desender · L. · Losty · P. · Ertresvag · K. · Tiddens · H. A. W. M. · Wijnen · R. M. H
Introduction

A worldwide lack of consensus exists on the optimal management of asymptomatic congenital pulmonary airway malformation (CPAM) even though the incidence is increasing. Either a surgical resection is performed or a wait-and-see policy is employed, depending on the treating physician. Management is largely based on expert opinion and scientific evidence is scarce. Wide variations in outcome measures are seen between studies making comparison difficult thus highlighting the lack of universal consensus in outcome measures as well. We aim to define a core outcome set which will include the most important core outcome parameters for paediatric patients with an asymptomatic CPAM.

Methods and analysis

This study will include a critical appraisal of the current literature followed by a three-stage Delphi process with two stakeholder groups. One surgical group including paediatric as well as thoracic surgeons, and a non-surgeon group including paediatric pulmonologists, intensive care and neonatal specialists. All participants will score outcome parameters according to their level of importance and the most important parameters will be determined by consensus.

Ethics and dissemination

Electronic informed consent will be obtained from all participants. Ethical approval is not required. After the core outcome set has been defined, we intend to design an international randomised controlled trial: the COllaborative Neonatal NEtwork for the first CPAM Trial, which will be aimed at determining the optimal management of patients with asymptomatic CPAM.

Expert consensus on moving towards a value-based healthcare system in the Netherlands: a Delphi study

Por: Steinmann · G. · Delnoij · D. · van de Bovenkamp · H. · Groote · R. · Ahaus · K.
Objectives

While the uptake of value-based health care (VBHC) is remarkable, uncertainty prevails regarding the most important actions and practices in establishing a value-based healthcare system. In this paper, we generate expert consensus on the most important aspects of VBHC.

Design

The Delphi technique was used to reach consensus on the most important practices in moving towards a value-based healthcare system.

Setting and participants

A Dutch expert panel consisting of nine members participated in a two-round survey.

Primary and secondary outcome measures

We developed 39 initial items based on the pioneering literature on VBHC and recent health policies in the Netherlands. Experts rated the importance of each item on a 4-point Likert scale. Experts could change items or add new ones as they saw fit. We retained items that were rated (very) important by ≥80% of the panel.

Results

After two survey rounds, 32 items (72%) were included through expert consensus. Experts unanimously agree on the importance of shared decision-making, with this item uniquely obtaining the maximum score. Experts also reached consensus on the importance of outcome measurements, a focus on medical conditions, and full cycles of care. No consensus was reached on the importance of benchmarking.

Conclusion

This paper provides new insight into the most important actions and practices for establishing a value-based healthcare system in the Netherlands. Interestingly, several of our findings contrast with the pioneering literature on VBHC. This raises the question whether VBHC’s widespread international uptake indicates its actual implementation, or rather that the original concept primarily serves as an inspiring idea.

Study protocol: content and perceived educational utility of different modalities of clinical teaching visit (CTV) workplace-based assessments within Australian general practice vocational training: a cross-sectional study

Por: Fielding · A. · Mundy · B. E. · Tapley · A. · Klein · L. · Gani · S. · Bentley · M. · Boland · R. · Zbaidi · L. · van Driel · M. L. · Holliday · E. · Magin · P.
Introduction

Clinical teaching visits (CTVs) are formative workplace-based assessments that involve a senior general practitioner (GP) observing a clinical practice session of a general practice registrar (specialist vocational GP trainee). These visits constitute a key part of Australian GP training. Despite being mandatory and resource-intensive, there is a paucity of evidence regarding the content and educational utility of CTVs. This study aims to establish the content and educational utility of CTVs across varying practice settings within Australia, as perceived by registrars and their assessors (‘CT visitors’). In addition, this study aims to establish registrar, CT visitor and practice factors associated with CTV content and perceived CTV utility ratings.

Methods and analysis

This study will collect data prospectively using online questionnaires completed soon after incident CTVs. Participants will be registrars and CT visitors of CTVs conducted from March 2020 to January 2021. The setting is three Regional Training Organisations across four Australian states and territories (encompassing 37% of Australian GP registrars).

Outcome factors will be a number of specified CTV content elements occurring during the CTV as well as participants’ perceptions of CTV utility, which will be analysed using univariate and multivariable regression.

Ethics and dissemination

Ethics approval has been granted by the University of Newcastle Human Research Ethics Committee, approval number H-2020-0037. Study findings are planned to be disseminated via conference presentation, peer-reviewed journals, educational practice translational workshops and the GP Synergy research subwebsite.

Educational needs in the COVID-19 pandemic: a Delphi study among doctors and nurses in Wuhan, China

Por: Hou · X. · Hu · W. · Russell · L. · Kuang · M. · Konge · L. · Nayahangan · L. J.
Objective

To identify theoretical and technical aspects regarding treatment, prevention of spread and protection of staff to inform the development of a comprehensive training curriculum on COVID-19 management.

Design

Cross-sectional study.

Setting

Nine hospitals caring for patients with COVID-19 in Wuhan, China.

Participants

134 Chinese healthcare professionals (74 doctors and 60 nurses) who were deployed to Wuhan, China during the COVID-19 epidemic were included. A two-round Delphi process was initiated between March and May 2020. In the first round, the participants identified knowledge, technical and behavioural (ie, non-technical) skills that are needed to treat patients, prevent spread of the virus and protect healthcare workers. In round 2, the participants rated each item according to its importance to be included in a training curriculum on COVID-19. Consensus for inclusion in the final list was set at 80%.

Primary outcome measures

Knowledge, technical and behavioural (ie, non-technical) skills that could form the basis of a training curriculum for COVID-19 management.

Results

In the first round 1398 items were suggested by the doctors and reduced to 67 items after content analysis (treatment of patients: n=47; infection prevention and control: n=20). The nurses suggested 1193 items that were reduced to 70 items (treatment of patients: n=49; infection prevention and control: n=21). In round 2, the response rates were 82% in doctors and 93% in nurses. Fifty-eight items of knowledge, technical and behavioural skills were agreed on by the doctors to include in the final list. For the nurses, 58 items were agreed on.

Conclusions

This needs assessment process resulted in a comprehensive list of knowledge, technical and behavioural skills for COVID-19 management. Educators can use these to guide decisions regarding content of training curricula not only for COVID-19 management but also in preparation for future viral pandemic outbreaks.

Improving the patient-centred care of children with life-altering skin conditions using feedback from electronic patient-reported outcome measures: protocol for a hybrid effectiveness-implementation study (PEDS-ePROM)

Por: Tyack · Z. · Simons · M. · McPhail · S. M. · Harvey · G. · Zappala · T. · Ware · R. S. · Kimble · R. M.
Introduction

Using patient-reported outcome measures (PROMs) with children have been described as ‘giving a voice to the child’. Few studies have examined the routine use of these measures as potentially therapeutic interventions. This study aims to investigate: (1) the effectiveness of feedback using graphical displays of information from electronic PROMs (ePROMs) that target health-related quality of life, to improve health outcomes, referrals and treatment satisfaction and (2) the implementation of ePROMs and graphical displays by assessing acceptability, sustainability, cost, fidelity and context of the intervention and study processes.

Methods and analysis

A hybrid II effectiveness-implementation study will be conducted from February 2020 with children with life-altering skin conditions attending two outpatient clinics at a specialist paediatric children’s hospital. A pragmatic randomised controlled trial and mixed methods process evaluation will be completed. Randomisation will occur at the child participant level. Children or parent proxies completing baseline ePROMs will be randomised to: (1) completion of ePROMs plus graphical displays of ePROM results to treating clinicians in consultations, versus (2) completion of ePROMs without graphical display of ePROM results. The primary outcome of the effectiveness trial will be overall health-related quality of life of children. Secondary outcomes will include other health-related quality of life outcomes (eg, child psychosocial and physical health, parent psychosocial health), referrals and treatment satisfaction. Trial data will be primarily analysed using linear mixed-effects models; and implementation data using inductive thematic analysis of interviews, meeting minutes, observational field notes and study communication mapped to the Consolidated Framework for Implementation Research.

Ethics and dissemination

Ethical approval was obtained from Children’s Health Queensland Human Research Ethics Committee (HREC/2019/QCHQ/56290), The University of Queensland (2019002233) and Queensland University of Technology (1900000847). Dissemination will occur through stakeholder groups, scientific meetings and peer-reviewed publications.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12620000174987).

Effects of an optimised approach to home-based respiratory care in individuals with amyotrophic lateral sclerosis: a study protocol for a randomised controlled trial

Por: Pondofe · K. · Fregonezi · G. A. F. · Brito · O. · Dourado Junior · M. E. · Torres-Castro · R. · Resqueti · V. R.
Introduction

This study aims to investigate the effects of an optimal home-based respiratory care protocol in individuals with amyotrophic lateral sclerosis (ALS).

Methods and analysis

This is a randomised, blinded controlled trial involving patients diagnosed with ALS, both sexes, age between 18 and 80 years. Patients will be randomly allocated into the conventional respiratory care (CRC) group and the optimised respiratory care home-based (ORC) group. Primary outcomes will be peak cough flow, the number of exacerbations and ALS Functional Rating Scale Revised. Secondary outcomes will include chest wall volumes, maximal respiratory pressures, sniff nasal inspiratory pressure, nasal expiratory pressure and forced vital capacity (FVC), forced expiratory volume in the 1st second (FEV1) and FEV1/FVC. The CRC group will receive educational information about respiratory care at the clinic. The ORC group will receive conventional care and home-based care. The clinical status of all individuals will be monitored weekly through telephone calls. A 6-month intervention is planned, the outcomes will be assessed every 3 months and 3 and 6 months follow-up after final evaluation. The primary and secondary results will be described as average or median for continuous variables and absolute and relative frequencies for qualitative variables. Treatment effects or differences between the outcomes (baseline, 3 months and 6 months) of the study groups will be analysed using an analysis of variance. The level of significance will be set as p≤0.05.

Ethics and dissemination

The research ethics committee approved the study. It is expected to evaluate respiratory function in patients with ALS in the short, medium and long terms with home-based care protocol applied. The disease’s rapid progression is a limitation for performing a long-term clinical study.

Trial registration number

RBR-3z23ts; Pre-results.

Travel-related control measures to contain the COVID-19 pandemic: an evidence map

Por: Movsisyan · A. · Burns · J. · Biallas · R. · Coenen · M. · Geffert · K. · Horstick · O. · Klerings · I. · Pfadenhauer · L. M. · von Philipsborn · P. · Sell · K. · Strahwald · B. · Stratil · J. M. · Voss · S. · Rehfuess · E.
Objectives

To comprehensively map the existing evidence assessing the impact of travel-related control measures for containment of the SARS-CoV-2/COVID-19 pandemic.

Design

Rapid evidence map.

Data sources

MEDLINE, Embase and Web of Science, and COVID-19 specific databases offered by the US Centers for Disease Control and Prevention and the WHO.

Eligibility criteria

We included studies in human populations susceptible to SARS-CoV-2/COVID-19, SARS-CoV-1/severe acute respiratory syndrome, Middle East respiratory syndrome coronavirus/Middle East respiratory syndrome or influenza. Interventions of interest were travel-related control measures affecting travel across national or subnational borders. Outcomes of interest included infectious disease, screening, other health, economic and social outcomes. We considered all empirical studies that quantitatively evaluate impact available in Armenian, English, French, German, Italian and Russian based on the team’s language capacities.

Data extraction and synthesis

We extracted data from included studies in a standardised manner and mapped them to a priori and (one) post hoc defined categories.

Results

We included 122 studies assessing travel-related control measures. These studies were undertaken across the globe, most in the Western Pacific region (n=71). A large proportion of studies focused on COVID-19 (n=59), but a number of studies also examined SARS, MERS and influenza. We identified studies on border closures (n=3), entry/exit screening (n=31), travel-related quarantine (n=6), travel bans (n=8) and travel restrictions (n=25). Many addressed a bundle of travel-related control measures (n=49). Most studies assessed infectious disease (n=98) and/or screening-related (n=25) outcomes; we found only limited evidence on economic and social outcomes. Studies applied numerous methods, both inferential and descriptive in nature, ranging from simple observational methods to complex modelling techniques.

Conclusions

We identified a heterogeneous and complex evidence base on travel-related control measures. While this map is not sufficient to assess the effectiveness of different measures, it outlines aspects regarding interventions and outcomes, as well as study methodology and reporting that could inform future research and evidence synthesis.

Investigating correlates of athletic identity and sport-related injury outcomes: a scoping review

Por: Renton · T. · Petersen · B. · Kennedy · S.
Objectives

To conduct a scoping review that (1) describes what is known about the relationship between athletic identity and sport-related injury outcomes and (2) describes the relationship that an injury (as an exposure) has on athletic identity (as an outcome) in athletes.

Design

Scoping review.

Participants

A total of n=1852 athletes from various sport backgrounds and levels of competition.

Primary and secondary outcome measures

The primary measure used within the studies identified was the Athletic Identity Measurement Scale. Secondary outcome measures assessed demographic, psychosocial, behavioural, physical function and pain-related constructs.

Results

Twenty-two studies were identified for inclusion. Samples were dominated by male, Caucasian athletes. The majority of studies captured musculoskeletal injuries, while only three studies included sport-related concussion. Athletic identity was significantly and positively associated with depressive symptom severity, sport performance traits (eg, ego-orientation and mastery-orientation), social network size, physical self-worth, motivation, rehabilitation overadherence, mental toughness and playing through pain, as well as injury severity and functional recovery outcomes. Findings pertaining to the association that an injury (as an exposure) had on athletic identity (as an outcome) were inconsistent and limited.

Conclusions

Athletic identity was most frequently associated with psychosocial, behavioural and injury-specific outcomes. Future research should seek to include diverse athlete samples (eg, women, athletes of different races, para-athletes) and should continue to reference theoretical injury models to inform study methodologies and to specify variables of interest for further exploration.

CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial

Por: Norgaard · S. K. · Mathiesen · E. R. · Norgaard · K. · Clausen · T. D. · Damm · P. · Ringholm · L.
Introduction

Faster-acting insulin aspart (Fiasp) is approved for use in pregnancy and lactation, but no clinical study has evaluated its effects during this life stage in women with pre-existing diabetes. The aim of the CopenFast trial is to evaluate the effect of Fiasp compared with insulin aspart (NovoRapid) on maternal glycaemic control during pregnancy, delivery and lactation and on fetal growth and infant health.

Methods and analysis

An open-label randomised controlled trial of pregnant women with type 1 or type 2 diabetes including women on multiple daily injection (MDI) therapy or insulin pump therapy. During a 2-year inclusion period, approximately 220 women will be randomised 1:1 to Fiasp or NovoRapid in early pregnancy and followed until 3 months after delivery. At 9, 21 and 33 gestational weeks and during planned induction of labour or caesarean section, women are offered blinded continuous glucose monitoring (CGM) for 7 days. Randomisation will stratify for type of diabetes and insulin treatment modality (MDI or insulin pump therapy, respectively). Health status of the infants will be followed until 3 months of age. The primary outcome is birth weight SD score adjusted for gestational age and gender. Secondary outcomes include maternal glycaemic control including glycated haemoglobin, preprandial and postprandial self-monitored plasma glucose levels, episodes of mild and severe hypoglycaemia, maternal gestational weight gain and weight retention, CGM time spent in, above and below target ranges as well as pregnancy outcomes including pre-eclampsia, preterm delivery, perinatal mortality and neonatal morbidity. Data analysis will be performed according to the intention-to-treat principle.

Ethics and dissemination

The trial has been approved by the Regional Ethics Committee (H-19029966) on 7 August 2019. Results will be sought disseminated in peer-reviewed journals and at scientific meetings.

Trial registration number

NCT03770767

Magnitude and associated factors of unmet need for family planning among rural women in Ethiopia: a multilevel cross-sectional analysis

Por: Alem · A. Z. · Agegnehu · C. D.
Objective

This study was aimed to assess the magnitude and associated factors of unmet need for family planning among rural women in Ethiopia.

Design

Cross-sectional study.

Setting

Ethiopia.

Participants

Reproductive age group women.

Primary outcome

Unmet need for family planning.

Methods

This study drew data from Ethiopian Demographic and Health Survey, which was conducted from 18 January to 27 June 2016. A total of 8327 rural reproductive-aged (15–49 years) women were included. A two-level multivariable logistic regression model was carried out to identify individual and community-level factors associated with unmet need for family planning. Adjusted OR (AOR) with a 95% CI was used to assess the strength of association between independent and dependent variables.

Results

The overall unmet need for family planning among rural women was 24.08% (95% CI 23.17 to 25.01), of which 14.79% was for spacing and 9.29% for limiting. Number of children (AOR=1.15; 95% CI 1.07 to 1.24) and working status of women (AOR=1.18; 95% CI 1.02 to 1.37) were significantly associated with a higher odds of unmet need for family planning. However, women with primary education (AOR=0.87; 95% CI 0.74 to 0.94), women married at age 18 or later (AOR=0.82; 95% CI 0.70 to 0.96), women from households with high wealth index (AOR=0.77; 95% CI 0.64 to 0.94), women who deem distance to a health facility as not a big problem (AOR=0.85; 95% CI 0.73 to 0.99), women from communities with a high percentage of educated women (AOR=0.73; 95% CI 0.59 to 0.89) and women who live in communities with high media exposure (AOR=0.81, 95% CI 0.68 to 0.98) were significantly associated with a lower odds of unmet needs for family planning.

Conclusion

Unmet need for family planning among reproductive-aged women in rural Ethiopia was high. Number of children, working status of women, women’s education, age at first marriage, household wealth, distance to a health facility, community women’s education and community media exposure were significantly associated with unmet needs for family planning. Therefore, to reduce unmet need for family planning, public health policymakers should consider both individual and community-level factors when designing FP programmes and emphasis should be given to high-risk populations.

Chinesisation, adaptation and validation of the Chelsea Critical Care Physical Assessment Tool in critically ill patients: a cross-sectional observational study

Por: Zhang · Z. · Wang · G. · Wu · Y. · Guo · J. · Ding · N. · Jiang · B. · Wei · H. · Li · B. · Yue · W. · Tian · J.
Purpose

To translate and adapt the Chelsea Critical Care Physical Assessment Tool (CPAx) into Chinese version (‘CPAx-Chi’), test the reliability and validity of CPAx-Chi, and verify the cut-off point for the diagnosis of intensive care unit-acquired weakness (ICU-AW).

Study design

Cross-sectional observational study.

Methods

Forward and back translation, cross-cultural adaptation and pretesting of CPAx into CPAx-Chi were based on the Brislin model. Participants were recruited from the general ICU of five third-grade class-A hospitals in western China. Two hundred critically ill adult patients (median age: 53 years; 64% men) with duration of ICU stay ≥48 hours and Glasgow Coma Scale ≥11 were included in this study. Two researchers simultaneously and independently assessed eligible patients using the Medical Research Council Muscle Score (MRC-Score) and CPAx-Chi.

Results

The content validity index of items was 0.889. The content validity index of scale was 0.955. Taking the MRC-Score scale as standard, the criterion validity of CPAx-Chi was r=0.758 (p

Conclusions

CPAx-Chi demonstrated content validity, criterion-related validity and reliability. CPAx-Chi showed the best accuracy in assessment of patients at risk of ICU-AW with good sensitivity and specificity at a recommended cut-off of 31.

Could social prescribing contribute to type 2 diabetes prevention in people at high risk? Protocol for a realist, multilevel, mixed methods review and evaluation

Por: Calderon Larranaga · S. · Clinch · M. · Greenhalgh · T. · Finer · S.
Introduction

Social prescribing is an innovation being widely adopted within the UK National Health Service policy as a way of improving the management of people with long-term conditions, such as type 2 diabetes (T2D). It generally involves linking patients in primary care with non-medical community-based interventions. Despite widespread national support, evidence for the effectiveness of social prescribing is both insufficient and contested. In this study, we will investigate whether social prescribing can contribute to T2D prevention and, if so, when, how and in what circumstances it might best be introduced.

Methods and analysis

We will draw on realist evaluation to investigate the complex interpersonal, organisational, social and policy contexts in which social prescribing relevant to T2D prevention is implemented. We will set up a stakeholder group to advise us throughout the study, which will be conducted over three interconnected stages. In stage 1, we will undertake a realist review to synthesise the current evidence base for social prescribing. In stage 2, we will investigate how social prescribing relevant to people at high risk of T2D ‘works’ in a multiethnic, socioeconomically diverse community and any interactions with existing T2D prevention services using qualitative, quantitative and realist methods. In stage 3 and building on previous stages, we will synthesise a ‘transferable framework’ that will guide implementation and evaluation of social prescribing relevant to T2D prevention at scale.

Ethics and dissemination

National Health Service ethics approval has been granted (reference 20/LO/0713). This project will potentially inform the adaptation of social prescribing services to better meet the needs of people at high risk of T2D in socioeconomically deprived areas. Findings may also be transferable to other long-term conditions. Dissemination will be undertaken as a continuous process, supported by the stakeholder group. Tailored outputs will target the following audiences: (1) service providers and commissioners; (2) people at high risk of T2D and community stakeholders; and (3) policy and strategic decision makers.

PROSPERO registration number

CRD42020196259.

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