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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.

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.

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.

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.

Factors associated with mobile phone usage to access maternal and child healthcare among women of urban slums in Dhaka, Bangladesh: a cross-sectional study

Por: Mistry · S. K. · Akter · F. · Yadav · U. N. · Hossain · M. B. · Sichel · A. · Labrique · A. B. · Storisteanu · D. M. L.
Introduction

With the acute shortage of human resources and infrastructure, mobile phones can be a critical tool for accessing health services and strengthening health systems in Bangladesh. Yet, there is a scarcity of evidence on the use of mobile phones in this context for accessing health services. In this study, we sought to explore the current use of mobile phones for accessing maternal and child healthcare and its determinants among recently delivered women in urban slums of Bangladesh.

Methods

The data were collected through interviewing 800 recently delivered women from eight slums of Dhaka city of Bangladesh during May and June 2018. The study followed a cross-sectional design and a two-stage cluster random sampling procedure was followed. A pretested structured questionnaire was employed to collect information. Chi square tests were performed for descriptive analyses and a multilevel binary logistic regression model was executed to explore the determinants of mobile phone usage for accessing maternal and childcare among the participants.

Results

Overall, 73.8% of study participants used mobile phones for accessing maternal and child healthcare. After adjusting for potential confounders, participants’ age, husband’s occupation, sex of household head, women’s ownership of mobile phones and household wealth status were found to be significantly associated with higher odds of using mobile phones to access maternal and child healthcare.

Conclusion

The study highlighted the possibility of implementing large-scale mobile health (mHealth) interventions in slum settlements for accessing maternal and child healthcare and is a sustainable mitigation strategy for the acute health worker crisis in Bangladesh. The findings of this study are particularly crucial for policymakers and practitioners while they revise the health policy to incorporate mHealth interventions as highlighted in the recently initiated Digital Health Strategy of Bangladesh.

Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

Por: Elliott · C. · Alexander · C. · Salt · A. · Spittle · A. J. · Boyd · R. N. · Badawi · N. · Morgan · C. · Silva · D. · Geelhoed · E. · Ware · R. S. · Ali · A. · McKenzie · A. · Bloom · D. · Sharp · M. · Ward · R. · Bora · S. · Prescott · S. · Woolfenden · S. · Le · V. · Davidson · S.-A. · Thorn
Introduction

The current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.

Method and analysis

Early Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.

Ethics and dissemination

Ethics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).

Trial registration number

ACTRN12619001422112.

Investigation of hypertensive arteriopathy-related and cerebral amyloid angiopathy-related small vessel disease scores in patients from a memory clinic: a prospective single-centre study

Por: Matsuda · K. · Shindo · A. · Ii · Y. · Tabei · K.-i. · Ueda · Y. · Ishikawa · H. · Matsuura · K. · Yoshimaru · K. · Taniguchi · A. · Kato · N. · Satoh · M. · Maeda · M. · Tomimoto · H.
Objective

The severity of cerebral small vessel disease (SVD) is assessed through neuroimaging findings, including hypertensive arteriopathy (HA)-SVD and cerebral amyloid angiopathy (CAA)-SVD. HA-SVD and CAA-SVD have been collectively estimated as total scores: the HA-SVD and CAA-SVD scores, respectively. Previous reports suggest that HA-SVD scores are associated with cognitive function; however, the relationship between CAA-SVD scores and cognitive function remains unclear. Therefore, we examined the association between CAA-SVD scores and cognitive function. Furthermore, we developed a modified CAA-SVD score considering cortical microinfarcts and posterior dominant white matter hyperintensities, which are imaging findings of CAA, and examined the association between these scores and cognitive function in the same patient group.

Design

Prospective study.

Setting

Single centre study from a memory clinic.

Participants

Subjects were diagnosed with mild cognitive impairment (MCI) or mild dementia in our memory clinic between February 2017 and July 2019 and underwent clinical dementia rating scale and brain MRI assessment. A total of 42 patients (aged 75.3±9.12 years) were registered prospectively.

Primary and secondary outcome measures

We evaluated intellectual function, memory, frontal lobe function and constructional ability. Furthermore, the relationship between each score and cognitive function was examined.

Results

The CAA-SVD score showed significant associations with cognitive function (R2=0.63, p=0.016), but the HA-SVD score did not (R2=0.41, p=0.35). The modified CAA-SVD score was also significantly associated with cognitive function (R2=0.65, p=0.008).

Conclusion

Cognitive function is associated with the CAA-SVD score, and more efficiently with the modified CAA-SVD score, in memory clinic patients. Although we have not validated the weighting of the modified CAA-SVD score, these scores can be a predictor of cognitive deterioration in patients with MCI and mild dementia.

Published patterns of spin in biomedical literature: a protocol for a meta-research study

Por: Su · N. · van der Linden · M. · van der Heijden · G. J. · Listl · S. · Schandelmaier · S. · Faggion Jr · C. M.
Introduction

Spin is defined as reporting practices that distort the interpretation of results and create misleading conclusions by suggesting more favourable results. Such unjustifiable and misleading misrepresentation may negatively influence the development of further studies, clinical practice and healthcare policies. Spin manifests in various patterns in different sections of publications (titles, abstracts and main texts). The primary aim of this study is to identify reported spin patterns and assess the prevalence of spin in general, and the prevalence of spin patterns reported in biomedical literature based on previously published systematic reviews and literature reviews on spin.

Methods and analysis

PubMed, EMBASE and SCOPUS will be searched to identify systematic or literature reviews on spin in biomedicine. To improve the comprehensiveness of the search, the snowballing method will be used to broaden the search. The data on spin-related outcomes and characteristics of the included studies will be extracted. The methodological quality of the included studies will be assessed with selective items of the A MeaSurement Tool to Assess systematic Reviews-2 checklist. A new classification scheme for spin patterns will be developed if the classifications of spin patterns identified in the included studies vary. The prevalence of spin and spin patterns will be pooled based on meta-analyses if the classification schemes for spin are comparable across included studies. Otherwise, the prevalence will be described qualitatively. The seriousness of spin patterns will be assessed based on a Delphi consensus study.

Ethics and dissemination

This study has been approved by the Academic Centre for Dentistry Amsterdam Ethics Review Committee (2020250). The study will be submitted to a peer-reviewed scientific journal.

Registration

Open Science Framework: osf.io/hzv6e

Study protocol of a systematic review and qualitative evidence synthesis using two different approaches: Healthcare related needs and desires of older people with post-stroke aphasia

Introduction

Stroke is a frequent disease in the older population of Western Europe with aphasia as a common consequence. Aphasia is known to impede targeting treatment to individual patients’ needs and therefore may reduce treatment success. In Germany, the postacute care of patients who had stroke is provided by different healthcare institutions of different sectors (rehabilitation, nursing and primary care) with substantial difficulties to coordinate services. We will conduct two qualitative evidence syntheses (QESs) aiming at exploring distinct healthcare needs and desires of older people living with poststroke aphasia. We thereby hope to support the development of integrated care models based on needs of patients who are very restricted to communicate them. Since various methods of QESs exist, the aim of the study embedding the two QESs was to determine if findings differ according to the approach used.

Methods and analysis

We will conduct two QESs by using metaethnography (ME) and thematic synthesis (ThS) independently to synthesise the findings of primary qualitative studies. The main differences between these two methods are the underlying epistemologies (idealism (ME) vs realism (ThS)) and the type of research question (emerging (ME) vs fixed (ThS)).

We will search seven bibliographical databases. Inclusion criteria comprise: patients with poststroke aphasia, aged 65 years and older, studies in German/English, all types of qualitative studies concerning needs and desires related to healthcare or the healthcare system. The protocol was registered in the International Prospective Register of Systematic Reviews, follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and includes three items from the Enhancing Transparency in Reporting the synthesis of Qualitative Research checklist.

Ethics and dissemination

Ethical approval is not required. Findings will be published in a peer-reviewed journal and presented on national conferences.

Discrepancies in self-reported financial conflicts of interest disclosures by physicians: a systematic review

Por: Taheri · C. · Kirubarajan · A. · Li · X. · Lam · A. C. L. · Taheri · S. · Olivieri · N. F.
Background

There is a high prevalence of financial conflicts of interest (COI) between physicians and industry.

Objectives

To conduct a systematic review with meta-analysis examining the completeness of self-reported financial COI disclosures by physicians, and identify factors associated with non-disclosure.

Data sources

MEDLINE, Embase and PsycINFO were searched for eligible studies up to April 2020 and supplemented with material identified in the references and citing articles.

Data extraction and synthesis

Data were independently abstracted by two authors. Data synthesis was performed via systematic review of eligible studies and random-effects meta-analysis.

Main outcomes and measures

The proportion of discrepancies between physician self-reported disclosures and objective payment data was the main outcome. The proportion of discrepant funds and factors associated with non-disclosure were also examined.

Results

40 studies were included. The pooled proportion of COI discrepancies at the article level was 81% (range: 54%–98%; 95% CI 72% to 89%), 79% at the payment level (range: 71%–89%; 95% CI 67% to 89%), 93% at the authorship level (range: 71%–100%; 95% CI 79% to 100%) and 66% at the author level (range: 8%–99%; 95% CI 48% to 78%). The proportion of funds discrepant was 33% (range: 2%–77%; 95% CI 12% to 58%). There was high heterogeneity between studies across all five analyses (I2=94%–99%). Most undisclosed COI were related to food and beverage, or travel and lodging. While the most common explanation for failure to disclose was perceived irrelevance, a median of 45% of non-disclosed payments were directly or indirectly related to the work. A smaller monetary amount was the most common factor associated with nondisclosure.

Conclusions

Physician self-reports of financial COI are highly discrepant with objective data sources reporting payments from industry. Stronger policies are required to reduce reliance on physician self-reporting of financial COI and address non-compliance.

Algorithmic surveillance of ICU patients with acute respiratory distress syndrome (ASIC): protocol for a multicentre stepped-wedge cluster randomised quality improvement strategy

Por: Marx · G. · Bickenbach · J. · Fritsch · S. J. · Kunze · J. B. · Maassen · O. · Deffge · S. · Kistermann · J. · Haferkamp · S. · Lutz · I. · Voellm · N. K. · Lowitsch · V. · Polzin · R. · Sharafutdinov · K. · Mayer · H. · Kuepfer · L. · Burghaus · R. · Schmitt · W. · Lippert · J. · Riedel
Introduction

The acute respiratory distress syndrome (ARDS) is a highly relevant entity in critical care with mortality rates of 40%. Despite extensive scientific efforts, outcome-relevant therapeutic measures are still insufficiently practised at the bedside. Thus, there is a clear need to adhere to early diagnosis and sufficient therapy in ARDS, assuring lower mortality and multiple organ failure.

Methods and analysis

In this quality improvement strategy (QIS), a decision support system as a mobile application (ASIC app), which uses available clinical real-time data, is implemented to support physicians in timely diagnosis and improvement of adherence to established guidelines in the treatment of ARDS. ASIC is conducted on 31 intensive care units (ICUs) at 8 German university hospitals. It is designed as a multicentre stepped-wedge cluster randomised QIS. ICUs are combined into 12 clusters which are randomised in 12 steps. After preparation (18 months) and a control phase of 8 months for all clusters, the first cluster enters a roll-in phase (3 months) that is followed by the actual QIS phase. The remaining clusters follow in month wise steps. The coprimary key performance indicators (KPIs) consist of the ARDS diagnostic rate and guideline adherence regarding lung-protective ventilation. Secondary KPIs include the prevalence of organ dysfunction within 28 days after diagnosis or ICU discharge, the treatment duration on ICU and the hospital mortality. Furthermore, the user acceptance and usability of new technologies in medicine are examined. To show improvements in healthcare of patients with ARDS, differences in primary and secondary KPIs between control phase and QIS will be tested.

Ethics and dissemination

Ethical approval was obtained from the independent Ethics Committee (EC) at the RWTH Aachen Faculty of Medicine (local EC reference number: EK 102/19) and the respective data protection officer in March 2019. The results of the ASIC QIS will be presented at conferences and published in peer-reviewed journals.

Trial registration number

DRKS00014330.

Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol

Por: Jurek · L. · Occelli · P. · Denis · A. · Amestoy · A. · Maffre · T. · Dauchez · T. · Oreve · M.-J. · Baghdadli · A. · Schroder · C. · Jay · A. · Zelmar · A. · Revah-Levy · A. · Gallifet · N. · aldred · C. · Garg · S. · Green · J. · Touzet · S. · Geoffray · M.-M. · On behalf of IFPAD study
Introduction

Intervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained impact on autism symptom reduction. However, access to such evidence-based therapies for families is limited due to autism centres located in large urban areas. Using videoconferencing to deliver PACT training to parents may improve accessibility for families living in underserved areas.

Methods and analysis

This single-blind randomised controlled trial, involving six sites in France, will investigate the efficacy of a telehealth, videoconferencing-based, parent-mediated PACT therapy on autism symptoms, over a 12-month period. It will compare PACT plus treatment as usual (TAU) against TAU only in a cohort of 238 toddlers (119 per group) aged 18–36 months at inclusion and living with their families more than 40 min away from the specialist centres for autism. Primary outcome will include change of overall autism score on the Autism Diagnostic Observation Scale (ADOS) at 12 months. Secondary outcomes will measure change in child skills, child functioning, impact on parents (stress, health, priorities) and implementation characteristics. Repeated measures analyses will be used to test the effect of PACT intervention on the overall ADOS module 1 score over the 12-month study period. Linear mixed models will be used with time, treatment allocation and the interaction between treatment and time as fixed effects and individual variation as random effect.

Ethics and dissemination

This protocol (V.5, date: 25 October 2019) is approved by the French National Review Board (reference no 2018-A02516-49). The results will be disseminated via peer-reviewed journals

Trial registration number

NCT04244721.

Qualitative evaluation of a mandatory provincial programme auditing emergency department return visits

Por: Chartier · L. B. · Jalali · H. · Seaton · M. B. · Ovens · H. · Borgundvaag · B. · McLeod · S. L. · Dainty · K. N. · Ostrow · O.
Objective

The objective of this qualitative study was to evaluate the perceived impact and value of the Return Visit Quality Programme (RVQP), a mandatory province-wide emergency department audit programme.

Design

We employed an interpretive descriptive qualitative approach with maximum variation sampling to ensure diverse representation across several geographical and institutional factors. RVQP programme leads were invited to participate in semistructured interviews and snowball sampling was used to reach non-lead physicians to capture the perspectives of those working within the programme.

Setting

In Ontario’s RVQP, participating emergency departments must audit their return visits resulting in admission to identify issues that can be addressed through quality improvement initiatives.

Participants

Between June and August 2018, we interviewed 32 participants (local programme leads and non-lead physicians) from 23 out of the 86 participating centres.

Results

Participants’ perceived impact and value of the programme was associated with the existence (or absence) and nature of the local quality improvement culture, the implementation approach of the programme within their emergency departments, and key aspects of the programme pertaining to medicolegal concerns and resource availability.

Conclusions

This study of an innovative, large-scale programme aimed at promoting continuous quality improvement in emergency departments showed that while its perceived impact has been meaningful, there are key structural and operational elements that support and hinder this aim. Healthcare leaders should consider these findings when looking to implement large-scale audit or quality improvement programmes.

Emerging responses implemented to prevent and respond to violence against women and children in WHO European member states during the COVID-19 pandemic: a scoping review of online media reports

Por: Pearson · I. · Butler · N. · Yelgezekova · Z. · Nihlen · A. · Yordi Aguirre · I. · Quigg · Z. · Stöckl · H.
Objectives

This study aims to explore the strategies that governments and civil society organisations implemented to prevent and respond to the anticipated rise in violence against women and/or children (VAWC) during the 2019 novel coronavirus (COVID-19) pandemic.

Design

A scoping review and content analysis of online media reports.

Setting

WHO European region.

Methods

A scoping review of media reports and publications and a search of other grey literature (published from 1 January to 17 September 2020). Primary and secondary outcome measures included measures implemented by governments, public services and non-governmental and civil organisations to prevent or respond to VAWC during the early months of the COVID-19 pandemic.

Results

Our study found that in 52 of the 53 member states there was at least one measure undertaken to prevent or respond to VAWC during the pandemic. Government-led or government-sponsored measures were the most common, reported in 50 member states. Non-governmental and other civil society-led prevention and response measures were reported in 40 member states. The most common measure was the use of media and social media to raise awareness of VAWC and to provide VAWC services through online platforms, followed by measures taken to expand and/or maintain helpline services for those exposed to violence.

Conclusion

The potential increase in VAWC during COVID-19-imposed restrictions and lockdowns resulted in adaptations and/or increases in prevention and response strategies in nearly all member states. The strength of existing public health systems influenced the requirement and choice of strategies and highlights the need for sustaining and improving violence prevention and response services. Innovative strategies employed in several member states may offer opportunities for countries to strengthen prevention and responses in the near future and during similar emergencies.

Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR)

Por: Watson · J. · Coleman · E. · Jackson · C. · Bell · K. · Maynard · C. · Hickson · L. · Forster · A. · Fairhurst · C. · Hewitt · C. · Gardner · R. · Iley · K. · Gailey · L. · Thyer · N. J.
Objective

To establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service.

Design

Randomised controlled, open feasibility trial with embedded economic and process evaluations.

Setting

Audiology departments in two hospitals in two UK cities.

Participants

Twelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid.

Interventions

Consenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to ACE plus treatment-as-usual (intervention group) or treatment-as-usual only (control group).

Primary outcome measures

The primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery.

Secondary outcome measures

International Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible.

Results

Twelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size.

Conclusions

While ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month posthearing aid fitting point.

Trial registration number

ISRCTN28090877.

Economic evaluation of a novel community-based diabetes care model in rural Mexico: a cost and cost-effectiveness study

Por: Duan · K. I. · Rodriguez Garza · F. · Flores · H. · Palazuelos · D. · Maza · J. · Martinez-Juarez · L. A. · Elliott · P. F. · Moreno Lazaro · E. · Enriquez Rios · N. · Nigenda · G. · Palazuelos · L. · McBain · R. K.
Objectives

Diabetes is the leading cause of disability-adjusted life years in Mexico, and cost-effective care models are needed to address the epidemic. We sought to evaluate the cost and cost-effectiveness of a novel community-based model of diabetes care in rural Mexico, compared with usual care.

Design

We performed time-driven activity-based costing to estimate annualised costs associated with typical diabetes care in Chiapas, Mexico, as well as a novel diabetes care model known as Compañeros En Salud Programa de Enfermedades Crónicas (CESPEC). We conducted Markov chain analysis to estimate the cost-effectiveness of CESPEC compared with usual care from a societal perspective. We used patient outcomes from CESPEC in 2016, as well as secondary data from existing literature.

Setting

Rural primary care clinics in Chiapas, Mexico.

Participants

Adults with diabetes.

Interventions

CESPEC is a novel, comprehensive, diabetes care model that integrates community health workers, provider education, supply chain management and active case finding.

Outcome measure

The primary outcome was the incremental cost-effectiveness of CESPEC compared with care as usual, per quality-adjusted life year (QALY) gained, expressed in 2016 US dollars.

Results

The economic cost of the CESPEC diabetes model was US$144 per patient per year, compared with US$125 for diabetes care as usual. However, CESPEC care was associated with 0.13 additional years of health-adjusted life expectancy compared with usual care and 0.02 additional years in the first 5 years of treatment. This translated to an incremental cost-effectiveness ratio (ICER) of US$2981 per QALY gained over a patient’s lifetime and an ICER of US$10 444 over the first 5 years. Findings were robust to multiple sensitivity analyses.

Conclusions

CESPEC is a cost-effective, community-based model of diabetes care for patients in rural Mexico. Given the high prevalence and significant morbidity associated with diabetes in Mexico and other countries in Central America, this model should be considered for broader scale up and evaluation.

Study protocol for randomised clinical trial comparing the effectiveness of side-lying sleep positioning to back-lying at reducing oxygen desaturation resulting from obstructive sleep apnoea in infants with cleft palate (SLUMBRS2)

Por: Metryka · A. · Cuniffe · C. · Evans · H. J. · Gavlak · J. G. · Hudson · N. · Kirby · N. · Lakhanpaul · M. · Lin · Y.-L. · Murray · C. · Rajai · A. · Robson · H. · Schilder · A. · Walsh · T. · Bruce · I.
Introduction

The craniofacial abnormalities found in infants with cleft palate (CP) decrease their airway patency and increase their risk of obstructive sleep apnoea (OSA). We hypothesise that optimising sleep position in infants with CP may improve airway patency and offer a ‘low-cost, high-impact’ intervention to prevent the negative impacts of OSA. Because cleft centres give inconsistent advice about sleep position: some recommend back-lying and others side-lying, we will compare these in a randomised controlled trial.

Methods and analysis

The aim is to determine the clinical effectiveness of side-lying as compared with back-lying sleep positioning in terms of reducing oxygen desaturation resulting from OSA in 244 infants aged 3–5 weeks of age, diagnosed with an isolated CP in/by UK cleft centres. Primary outcome is the 4% Oxygen Desaturation Index measured using pulse oximetry during sleep.

Research plan

1. Multicentre randomised controlled trial of side-lying compared with back-lying sleep positioning in reducing oxygen desaturation resulting from OSA in infants with CP at one month of age. 2. Internal pilot questionnaire-based study to support parents and clinicians regarding study participation, seeking to identify and address any barriers to recruitment. Monitoring data from the internal pilot will be used in the final analysis. 3. Co-development of new UK recommendations with Cleft Lip and Palate Association (CLAPA) regarding sleep position for infants with CP.

Ethics and dissemination

The study protocol has received the favourable opinion of the West Midlands-South Birmingham Research Ethics Committee. Study results will be published on affiliated webpages and in peer-reviewed publications and conference contributions.

Trial registration number

NCT04478201.

Trends in long-term opioid prescriptions for musculoskeletal conditions in Australian general practice: a national longitudinal study using MedicineInsight, 2012-2018

Por: Black-Tiong · S. · Gonzalez-Chica · D. · Stocks · N.
Objective

Describe trends and patterns in long-term opioid prescriptions among adults with musculoskeletal conditions (MSK).

Design

Interrupted time-series analysis based on an open cohort study.

Setting

A representative sample of 402 Australian general practices contributing data to the MedicineInsight database.

Participants

811 174 patients aged 18+ years with an MSK diagnosis and three or more consultations in any two consecutive years between 2012 and 2018. Males represented 44.5% of the sample, 28.4% were 65+ years and 1.9% were Aboriginal or Torres Strait Islanders.

Primary and secondary outcome measures

Annual prevalence and cumulative incidence (%) of long-term opioid prescribing (3+ prescriptions in 90 days) among patients with an MSK. Average duration of these episodes in each year between 2012 and 2018.

Results

The prevalence of long-term opioid prescribing increased from 5.5% (95% CI 5.2 to 5.8) in 2012 to 9.1% (95% CI 8.8 to 9.7) in 2018 (annual change OR 1.09, 95% CI 1.08 to 1.09), but a slightly lower incidence was observed in 2018 (3.0% vs 3.6%–3.8% in other years; annual change OR 0.99, 95% CI 0.98 to 0.99). The incidence was between 37% and 52% higher among practices located in rural Australia or lower socioeconomic areas. Individual risk factors included increasing age (3.4 times higher among those aged 80+ years than the 18–34 years group in 2012, increasing to 4.8 times higher in 2018), identifying as Aboriginal or Torres Strait Islander (1.7–1.9 higher incidence than their peers), or living in disadvantaged areas (36%–57% more likely than among those living in wealthiest areas). Long-term opioid prescriptions lasted in average 287–301 days between 2012 and 2016, reducing to 229 days in 2017 and 140 days in 2018. A longer duration was observed in practices from more disadvantaged areas and females in all years, except in 2018.

Conclusions

The continued rise in the prevalence of long-term opioid prescribing is of concern, despite a recent reduction in the incidence and duration of opioid management.

Fetal Alcohol Spectrum Disorder resources for educators working within primary school settings: a scoping review protocol

Por: Lees · B. · Elliott · E. J. · Allsop · S. · Thomas · S. · Riches · J. · Nepal · S. · Rice · L. J. · Newton · N. · Mewton · L. · Teesson · M. · Stapinski · L. A.
Introduction

Many children affected by Fetal Alcohol Spectrum Disorder (FASD) exhibit neurocognitive delays that contribute to secondary consequences, including a disrupted school experience. Educators often have limited knowledge or experience in the identification, referral, management and accommodation of students with FASD. Effective resources and tools for educators are crucial to ensure these students are supported in their ongoing learning, development and school participation. This scoping review aims to identify and evaluate resources for educators that aid in the identification, management, or accommodation of students with FASD.

Methods and analysis

A search will be conducted in 9 peer-reviewed and 11 grey literature databases, Google search engine, two app stores and two podcast streaming services (planned search dates: November 2020 to February 2021). Relevant experts, including researchers, health professionals and individuals with lived experience of FASD, will be contacted in February and March 2021 to identify additional (including unpublished) resources. Resources will be selected based on registered, prespecified inclusion–exclusion criteria, and the quality of included resources will be critically appraised using a composite tool based on adaptions of the National Health and Medical Research Council FORM Framework and the iCAHE Guideline Quality Checklist. Relevant experts will also be requested to provide feedback on included resources.

Ethics and dissemination

Ethical approval for this scoping review was obtained from the University of Sydney Human Research Ethics Committee (2020/825). Results of the review will be disseminated through a peer-reviewed publication, conference presentations, and seminars targeting audiences involved in the education sector.

Trial registration

Open Science Framework: osf.io/73pjh.

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