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Hoy — Septiembre 16th 2019Tus fuentes RSS

Evaluating the impact of cycle helmet use on severe traumatic brain injury and death in a national cohort of over 11000 pedal cyclists: a retrospective study from the NHS England Trauma Audit and Research Network dataset

Por: Dodds · N. · Johnson · R. · Walton · B. · Bouamra · O. · Yates · D. · Lecky · F. E. · Thompson · J.
Objectives

In the last 10 years there has been a significant increase in cycle traffic in the UK, with an associated increase in the overall number of cycling injuries. Despite this, and the significant media, political and public health debate into this issue, there remains an absence of studies from the UK assessing the impact of helmet use on rates of serious injury presenting to the National Health Service (NHS) in cyclists.

Setting

The NHS England Trauma Audit and Research Network (TARN) Database was interrogated to identify all adult (≥16 years) patients presenting to hospital with cycling-related major injuries, during a period from 14 March 2012 to 30 September 2017 (the last date for which a validated dataset was available).

Participants

11 patients met inclusion criteria. Data on the use of cycling helmets were available in 6621 patients.

Outcome measures

TARN injury descriptors were used to compare patterns of injury, care and mortality in helmeted versus non-helmeted cohorts.

Results

Data on cycle helmet use were available for 6621 of the 11 192 cycle-related injuries entered onto the TARN Database in the 66 months of this study (93 excluded as not pedal cyclists). There was a significantly higher crude 30-day mortality in un-helmeted cyclists 5.6% (4.8%–6.6%) versus helmeted cyclists 1.8% (1.4%–2.2%) (p

Conclusions

This study suggests that there is a significant correlation between use of cycle helmets and reduction in adjusted mortality and morbidity associated with TBI and facial injury.

Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial

Por: Collins · K. A. · Ouedraogo · A. · Guelbeogo · W. M. · Awandu · S. S. · Stone · W. · Soulama · I. · Ouattara · M. S. · Nombre · A. · Diarra · A. · Bradley · J. · Selvaraj · P. · Gerardin · J. · Drakeley · C. · Bousema · T. · Tiono · A.
Introduction

A large proportion of malaria-infected individuals in endemic areas do not experience symptoms that prompt treatment-seeking. These asymptomatically infected individuals may retain their infections for many months during which sexual-stage parasites (gametocytes) are produced that may be transmissible to mosquitoes. Reductions in malaria transmission could be achieved by detecting and treating these infections early. This study assesses the impact of enhanced community case management (CCM) and monthly screening and treatment (MSAT) on the prevalence and transmissibility of malaria infections.

Methods and analysis

This cluster-randomised trial will take place in Sapone, an area of intense, highly seasonal malaria in Burkina Faso. In total, 180 compounds will be randomised to one of three interventions: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced CCM, comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus MSAT using RDTs. The study will be conducted over approximately 18 months covering two high-transmission seasons and the intervening dry season. The recruitment strategy aims to ensure that overall transmission and force of infection is not affected so we are able to continuously evaluate the impact of interventions in the context of ongoing intense malaria transmission. The main objectives of the study are to determine the impact of enhanced CCM and MSAT on the prevalence and density of parasitaemia and gametocytaemia and the transmissibility of infections. This will be achieved by molecular detection of infections in all study participants during start and end season cross-sectional surveys and routine sampling of malaria-positive individuals to assess their infectiousness to mosquitoes.

Ethics and dissemination

The study has been reviewed and approved by the London School of Hygiene and Tropical Medicine (LSHTM) (Review number: 14724) and The Centre National de Recherche et de Formation sur le Paludisme institutional review board (IRB) (Deliberation N° 2018/000002/MS/SG/CNRFP/CIB) and Burkina Faso national medical ethics committees (Deliberation N° 2018-01-010).

Findings of the study will be shared with the community via local opinion leaders and community meetings. Results may also be shared through conferences, seminars, reports, theses and peer-reviewed publications; disease occurrence data and study outcomes will be shared with the Ministry of Health. Data will be published in an online digital repository.

Trial registration number

NCT03705624.

Barriers and enablers for the implementation of clinical practice guidelines in China: a mixed-method study

Por: Jin · Y. · Li · Z. · Han · F. · Huang · D. · Huang · Q. · Cao · Y. · Weng · H. · Zeng · X.-T. · Wang · X. · Shang · H.-C.
Objectives

The aim of this study was to explore perspectives and reasoning of medical staff from Class A tertiary hospitals about the factors hindering and facilitating the uptake and use of clinical practice guidelines (CPGs) during medical procedures.

Design

Mixed-method research study to collect and analyse both quantitative and qualitative data.

Setting

Class A tertiary hospitals in China.

Participants

The inclusion criteria for the questionnaire survey and qualitative research were (1) medical practitioners and (2) years of practice: above 5 years in a tertiary hospital.

Methods

Questionnaires were distributed to medical staff in 11 cities to collect quantitative data. Frequency and ranking of barriers and enablers were analysed. Spearman correlations were computed to explore the correlation between years of practice, professional title ranking and educational background with self-reported guideline adherence. Using a constructivist grounded theory method, qualitative data were generated via in-depth face-to-face interviews with Chinese medical practitioners.

Results

A total of 359 medical practitioners were surveyed and 32 medical practitioners interviewed in 11 cities. Higher frequency and higher ranking of barriers all converged on ‘lack of access’, ‘less convenient’, ‘lack of applicability’ and ‘lack of evidence from Chinese sample’. Higher frequency and higher ranking of enablers converged on ‘Short formats presentation’, ‘Utilisation of various media’, ‘Information visualisation’ and ‘Linking to patient electronic medical records’. There were no relationships between characteristics of respondents with self-reported adherence. This research produced a theoretical understanding of the experience of medical practitioners when using guidelines. Themes identified were as follows: existing intrinsic flaws in guidelines, deficient or incomplete system mechanism and being ambiguous.

Conclusion

Our findings provide a comprehensive and culturally sensitive perspective in understanding guideline implementation in China. Strategies addressing those barriers should be further discussed and researched in the future.

Completeness of obstetric referral letters/notes from subdistrict to district level in three rural districts in Greater Accra region of Ghana: an implementation research using mixed methods

Por: Amoakoh-Coleman · M. · Ansah · E. · Klipstein-Grobusch · K. · Arhinful · D.
Objective

To assess the completeness of obstetric referral letters/notes at the district level of healthcare.

Design

An implementation research within three districts in Greater Accra region using mixed methods. During baseline and intervention phases, referral processes for all obstetric referrals from lower level facilities seen at the district hospitals were documented including indications for referrals, availability and completeness of referral notes/forms. An assessment of before and after intervention availability and completeness of referral forms was carried out. Focus group discussions, non-participant observations and in-depth interviews with health workers and pregnant women were conducted for qualitative data.

Setting

Three (3) districts in the Greater Accra region of Ghana.

Participants

Pregnant women referred from lower levels of care to and seen at the district hospital, health workers within the three districts and pregnant women attending antenatal clinic in the district and their family members or spouses.

Intervention

An enhanced interfacility referral communication system consisting of training, provision of communication tools for facilities, formation of hospital referral teams and strengthening feedback mechanisms.

Outcome

Completeness of obstetric referral letters/notes.

Results

Proportion of obstetric referrals with referral notes improved from 27.2% to 44.3% from the baseline to intervention period. Mean completeness (95% CI) of all forms was 71.3% (64.1% to 78.5%) for the study period, improving from 70.7% (60.4% to 80.9%) to 71.9% (61.1% to 82.7%) from baseline to intervention periods. Health workers reported they do not always provide referral notes and that most referral notes are not completely filled due to various reasons.

Conclusions

Most obstetric referrals did not have referral notes. The few notes provided were not completely filled. Interventions such as training of health workers, regular review of referral processes and use of electronic records can help improve both the provision of and completeness of the referral notes.

General practitioners predictions of their own patients health literacy: a cross-sectional study in Belgium

Por: Storms · H. · Aertgeerts · B. · Vandenabeele · F. · Claes · N.
Objectives

To support patients in their disease management, providing information that is adjusted to patients’ knowledge and ability to process health information (ie, health literacy) is crucial. To ensure effective health communication, general practitioners (GPs) should be able to identify people with limited health literacy. To this end, (dis)agreement between patients’ health literacy and GPs’ estimations thereof was examined. Also, characteristics impacting health literacy (dis)agreement were studied.

Design

Cross-sectional survey of general practice patients and GPs undertaken in 2016–17.

Setting

Forty-one general practices in two Dutch-speaking provinces in Belgium.

Participants

Patients (18 years of age and older) visiting general practices. Patients were excluded when having severe impairments (physical, mental, sensory).

Main outcome measures

Patients’ health literacy was assessed with 16-item European Health Literacy Survey Questionnaire. GPs indicated estimations on patients’ health literacy using a simple scale (inadequate; problematic; adequate). (Dis)agreement between patients’ health literacy and GPs’ estimations thereof (GPs’ estimations being equal to/higher/lower than patients’ health literacy) was measured using Kappa statistics. The impact of patient and GP characteristics, including duration of GP–patient relationships, on this (dis)agreement was examined using generalised linear logit model.

Results

Health literacy of patients (n=1375) was inadequate (n=201; 14.6%), problematic (n=299; 21.7%), adequate (n=875; 63.6%). GPs overestimated the proportion patients with adequate health literacy: adequate (n=1241; 90.3%), problematic (n=130; 9.5%) and inadequate (n=4; 0.3%). Overall, GPs’ correct; over-/underestimations of health literacy occurred for, respectively, 60.9%; 34.2%; 4.9% patients, resulting in a slight agreement (=0.033). The likelihood for GPs to over-/underestimate patients’ health literacy increases with decreasing educational level of patients; and decreasing number of years patients have been consulting with their GP.

Conclusions

Intuitively assessing health literacy is difficult. Patients’ education, the duration of GP–patient relationships and GPs’ gender impact GPs’ perceptions of patients’ health literacy.

Psychometric properties of the Arabic version of EPDS and BDI-II as a screening tool for antenatal depression: evidence from Qatar

Por: Naja · S. · Al-Kubaisi · N. · Chehab · M. · Al-Dahshan · A. · Abuhashem · N. · Bougmiza · I.
Objectives

The current study aimed to validate and determine the psychometric properties of the Arabic versions of the Beck Depression Inventory-II (BDI-II) and the Edinburgh Postnatal Depression Scale (EPDS) in Qatar.

Design

A cross-sectional study design was employed.

Setting

Antenatal care (ANC) clinics at nine primary healthcare centres.

Participants

Pregnant women (n=128) aged 15–46 years in different trimesters of pregnancy, attending the ANC clinics as well as capable of reading and writing in the Arabic language.

Results

A total of 128 participants were enrolled. On conducting the receiver operating characteristic (ROC) analysis, the EPDS showed a larger area under the curve at 0.951 than the BDI-II tool (0.912). Using Youden’s index, a score >13 on the EPDS (87% sensitivity, 90% specificity) and >19 on the BDI-II (96% sensitivity, 73% specificity) allowed for the greatest division between depressed and non-depressed participants.

Conclusion

To address the under-recognition of antenatal depression, physicians at primary healthcare centres in Qatar should be encouraged to utilise the EPDS to screen pregnant women seeking ANC services.

Patient and provider factors associated with enrolment in the pre-end-stage renal disease pay-for-performance programme in Taiwan: a cross-sectional study

Por: Hu · H.-Y. · Jian · F.-X. · Lai · Y.-j. · Yen · Y.-F. · Huang · N. · Hwang · S. J.
Objective

The incidence and prevalence of end-stage renal disease (ESRD) in Taiwan have been ranked the highest worldwide. Therefore, the National Health Insurance Administration has implemented the pre-ESRD pay-for-performance (P4P) programme since November 2006, which had significantly reduced the incidence of dialysis and all-cause mortality. This study aimed to identify the factors associated with the enrolment in the pre-ESRD P4P programme.

Design

Cross-sectional study.

Setting

The National Health Insurance research database 2007–2012 in Taiwan.

Participants

Patients with prevalent pre-ESRD aged more than 18 years between January 2007 and December 2012 were enrolled. Patient demographics and hospital characteristics between P4P and non-P4P groups were compared. A logistic regression model was used to analyse the factors associated with P4P enrolment, and a generalised estimating equation was used to verify the results.

Primary outcome measure

Enrolment in the pre-ESRD P4P programme.

Results

In total, 82 991 patients were enrolled in the programme, with a 45.6% participation rate. Patients who were males (adjusted OR (AOR)=0.89, 95% CI=0.86 to 0.91) and employed (AOR=0.95, 95% CI=0.92 to 0.97) had a significantly lower probability to be enrolled in the programme. Older patients (66–75 years old, AOR=1.23, 95% CI=1.14 to 1.33) and those with higher Charlson Comorbidities Index (CCI 5+, AOR=4.01, 95% CI=3.55 to 4.53) tended to be enrolled in the programme, while those in the 76+ years age group were not (AOR=1.03, 95% CI=0.95 to 1.13). Hospitals located in the central (AOR=1.48, 95% CI=1.05 to 2.08) and Kao-Ping regions (AOR=1.62, 95% CI=1.18 to 2.22) also tended to enrol patients in the pre-ESRD P4P programme. Enrolment rates increased over time.

Conclusion

Pre-ESRD patients of the female gender, greater age and more comorbidities were more likely to be enrolled in the pre-ESRD P4P programme. Healthcare providers and health authorities should focus attention on patients who are male, younger and with less comorbidities to improve the healthcare quality and equality for all pre-ESRD patients.

Reconceptualising precision public health

Por: Olstad · D. L. · McIntyre · L.

As currently conceived, precision public health is at risk of becoming precision medicine at a population level. This paper outlines a framework for precision public health that, in contrast to its current operationalisation, is consistent with public health principles because it integrates factors at all levels, while illuminating social position as a fundamental determinant of health and health inequities. We review conceptual foundations of public health, outline a proposed framework for precision public health and describe its operationalisation within research and practice. Social position shapes individuals’ unequal experiences of the social determinants of health. Thus, in our formulation, precision public health investigates how multiple dimensions of social position interact to confer health risk differently for precisely defined population subgroups according to the social contexts in which they are embedded, while considering relevant biological and behavioural factors. It leverages this information to uncover the precise and intersecting social structures that pattern health outcomes, and to identify actionable interventions within the social contexts of affected groups. We contend that studies informed by this framework offer greater potential to improve health than current conceptualisations of precision public health that do not address root causes. Moreover, expanding beyond master categories of social position and operationalising these categories in more precise ways across time and place can enrich public health research through greater attention to the heterogeneity of social positions, their causes and health effects, leading to the identification of points of intervention that are specific enough to be useful in reducing health inequities. Failure to attend to this level of particularity may mask the true nature of health risk, the causal mechanisms at play and appropriate interventions. Conceptualised thus, precision public health is a research endeavour with much to offer by way of understanding and intervening on the causes of poor health and health inequities.

As currently conceived, precision public health is at risk of becoming precision medicine at a population level. This paper outlines a framework for precision public health that, in contrast to its current operationalization, is consistent with public health principles because it integrates factors at all levels, while illuminating social position as a fundamental determinant of health and health inequities. We review conceptual foundations of public health, outline a proposed framework for precision public health and describe its operationalization within research and practice. Social position shapes individuals’ unequal experiences of the social determinants of health. Thus, in our formulation, precision public health investigates how multiple dimensions of social position interact to confer health risk differently for precisely defined population subgroups according to the social contexts in which they are embedded, while considering relevant biological and behavioural factors. It leverages this information to uncover the precise and intersecting social structures that pattern health outcomes, and to identify actionable interventions within the social contexts of affected groups. We contend that studies informed by this framework offer greater potential to improve health than current conceptualizations of precision public health that do not address root causes. Moreover, expanding beyond master categories of social position and operationalizing these categories in more precise ways across time and place can enrich public health research through greater attention to the heterogeneity of social positions, their causes and health effects, leading to identification of points of intervention that are specific enough to be useful in reducing health inequities. Failure to attend to this level of particularity may mask the true nature of health risk, the causal mechanisms at play and appropriate interventions. Conceptualized thus, precision public health is a research endeavour with much to offer by way of understanding and intervening on the causes of poor health and health inequities.

Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol

Por: Chabanne · R. · Fernandez-Canal · C. · Degos · V. · Lukaszewicz · A.-C. · Velly · L. · Mrozek · S. · Perrigault · P.-F. · Molliex · S. · Tavernier · B. · Dahyot-Fizelier · C. · Verdonk · F. · Caumon · E. · Masgrau · A. · Begard · M. · Chabert · E. · Ferrier · A. · Jaber · S. · Bazin · J.-
Introduction

Endovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observational studies with better outcomes associated with CS and small monocentric randomised controlled trials favouring GA. Therefore, we aim to evaluate the effect of CS versus GA on functional outcome and periprocedural complications in endovascular mechanical thrombectomy for anterior circulation AIS.

Methods and analysis

Anesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS) trial is an investigator initiated, multicentre, prospective, randomised controlled, two-arm trial. AMETIS trial will randomise 270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (≤15 or >15) and association of intravenous thrombolysis or not to receive either CS or GA. The primary outcome is a composite of functional independence at 3 months and absence of perioperative complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a modified Rankin Scale score of 0–2 by day 90. Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7.

Ethics and dissemination

The AMETIS trial was approved by an independent ethics committee. Study began in august 2017. Results will be published in an international peer-reviewed medical journal.

Trial registration number

NCT03229148.

A qualitative exploratory study of UK first-time fathers experiences, mental health and wellbeing needs during their transition to fatherhood

Por: Baldwin · S. · Malone · M. · Sandall · J. · Bick · D.
Objectives

To develop an understanding of men’s experiences of first-time fatherhood, their mental health and wellbeing needs.

Design

A qualitative study using semi-structured interviews. Data were analysed using framework analysis.

Setting

Two large National Health Service integrated care trusts covering four London (UK) local authority boroughs.

Participants

First-time fathers with children under 12 months of age were included. Maximum variation sampling was used, with 21 fathers recruited. Ten of these men described their ethnic background as Indian, seven as White British, one as Spanish, one as Black African, one as Black Caribbean and one as Pakistani. Participants’ ages ranged from 20 to over 60 years; completion of full-time education ranged from high school certificate to doctorate level; and annual income ranged from £15 000 to over £61 000. Non-English speaking fathers, those experiencing bereavement following neonatal death, stillbirth, pregnancy loss, sudden infant death, and fathers with existing severe mental illnesses were excluded.

Results

Nine major categories were identified: ‘preparation for fatherhood’, ‘rollercoaster of feelings’, ‘new identity’, ‘challenges and impact’, ‘changed relationship: we’re in a different place’, ‘coping and support’, ‘health professionals and services: experience, provision and support’, ‘barriers to accessing support’, and ‘men’s perceived needs: what fathers want’. Resident (residing with their partner and baby) and non-resident fathers in this study highlighted broadly similar needs, as did fathers for whom English was their first language and those for whom it was not. A key finding of this study relates to men’s own perceived needs and how they would like to be supported during the perinatal period, contributing to the current evidence.

Conclusions

This study provides insight into first-time fathers’ experiences during their transition to fatherhood, with important implications for healthcare policy makers, service providers and professionals for how perinatal and early years services are planned and provided for both new parents.

Winter cancellations of elective surgical procedures in the UK: a questionnaire survey of patients on the economic and psychological impact

Por: Herrod · P. J. J. · Adiamah · A. · Boyd-Carson · H. · Daliya · P. · El-Sharkawy · A. M. · Sarmah · P. B. · Hossain · T. · Couch · J. · Sian · T. S. · Wragg · A. · Andrew · D. R. · Parsons · S. L. · Lobo · D. N. · WES-Pi Study Group on behalf of the East Midlands Surgical Academic
Objectives

To quantify the economic and psychological impact of the cancellation of operations due to winter pressures on patients, their families and the economy.

Design

This questionnaire study was designed with the help of patient groups. Data were collected on the economic and financial burden of cancellations. Emotions were also quantified on a 5-point Likert scale.

Setting

Five NHS Hospital Trusts in the East Midlands region of England.

Participants

We identified 796 participants who had their elective operations cancelled between 1 November 2017 and 31 March 2018 and received responses from 339 (43%) participants.

Interventions

Participants were posted a modified version of a validated quality of life questionnaire with a prepaid return envelope.

Main outcome measures

The primary outcome measures were the financial and psychological impact of the cancellation of elective surgery on patients and their families.

Results

Of the 339 respondents, 163 (48%) were aged

Conclusions

The cancellation of elective surgery during the winter had an adverse impact on patients and the economy, including days of work lost and health-related anxiety. We recommend better planning, and provision of more notice and better support to patients.

Association between diabetes, metabolic syndrome and heart attack in US adults: a cross-sectional analysis using the Behavioral Risk Factor Surveillance System 2015

Por: Yang · G.-R. · Dye · T. D. · Li · D.
Objectives

Diabetes mellitus (DM) and metabolic syndrome (MS) are both associated with heart attack. Evidence regarding which condition—MS or DM—is better associated with heart attack, however, is limited. The purpose of this study is to examine DM and MS, and their comparative associations with heart attack, using the 2015 Behavioral Risk Factor Surveillance System (BRFSS).

Design

Cross-sectional study.

Methods

A total of 332 008 subjects aged over 18 years were included in the analysis. All subjects were classified into four groups based on their DM and MS status: neither DM nor MS, DM without MS, MS without DM, and both DM and MS. A weighted hierarchical logistic regression was used to examine the difference between the four groups in their association with the risk of a heart attack.

Results

Differences in weighted frequency distributions of gender, age category (over 45 years or not), smoking status, education, race, physical activity and daily vegetable and fruit consumption were significantly different across the four groups (p

Conclusion

The BRFSS 2015 data indicated that MS without DM and DM without MS had comparable effects on heart attack, and the odds of risk are doubled than US adults with neither DM nor MS.

Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care

Por: Wright · J. · Foster · A. · Cooper · C. · Sprange · K. · Walters · S. · Berry · K. · Moniz-Cook · E. · Loban · A. · Young · T. A. · Craig · C. · Dening · T. · Lee · E. · Beresford-Dent · J. · Thompson · B. J. · Young · E. · Thomas · B. D. · Mountain · G.
Introduction

Services are being encouraged to provide postdiagnostic treatment to those with dementia but the availability of evidence-based interventions following diagnosis has not kept pace with increase in demand. To address this need, the Journeying through Dementia (JtD) intervention was created. A randomised controlled trial (RCT), based on a pilot study, is in progress.

Methods and analysis

The RCT is a pragmatic, two-arm, parallel group trial designed to test the clinical and cost-effectiveness of JtD compared with usual care. Recruitment will be through NHS services, third sector organisations and Join Dementia Research. The sample size is 486 randomised (243 to usual care and 243 to the intervention usual care). Participants can choose to ask a friend or relative (supporter) to become involved in the study. The primary outcome measure for participants is Dementia-Related Quality of Life (DEMQOL), collected at baseline and at 8 months’ postrandomisation. Secondary outcome measures will be collected from participants and supporters at those visits. Participants will also be followed up at 12 months’ postrandomisation with a reduced set of measures. A process evaluation will be conducted through qualitative and fidelity substudies. Analyses will compare the two arms of the trial on an intention to treat as allocated basis. The primary analyses will compare the mean DEMQOL scores of the participants at 8 months between the two study arms. A cost-effectiveness analysis will consider the incremental cost per Quality Adjusted Life Years of the intervention compared with usual care. Qualitative and fidelity substudies will be analysed through framework analysis and fidelity assessment tools respectively.

Ethics and dissemination

REC and HRA approval were obtained. A Data Monitoring and Ethics Committee has been constituted. Dissemination will be via publications, conferences and social media. Intervention materials will be made open access.

Trial registration number

ISRCTN17993825.

The effect of primary care availability on antibiotic consumption in Hungary: a population based panel study using unfilled general practices

Por: Biro · A. · Elek · P.
Objective

We analyse the effect of primary care availability on antibiotic consumption and on the quality of antibiotic prescribing behaviour.

Design

Retrospective panel design, secondary analysis of settlement-level administrative panel data (n=2320 settlements, T=72 months).

Participants and setting

We analyse antibiotic consumption of the population of villages in Hungary, over years 2010 to 2015. We exploit the geographical and time variation in unfilled (mainly single-handed) general practices as a source of exogenous variation in the availability of primary care. We control for socioeconomic characteristics and settlement fixed effects in a panel regression framework.

Outcome measures

Antibiotic expenditures and days of therapy (DOT); consumption of narrow-spectrum and broad-spectrum antibiotics; consumption of Access, Watch and Reserve antibiotics according to the AWaRe categorisation; number of visits to the general practitioner (GP).

Results

If the general practice of a village becomes unfilled, the number of GP visits decreases on average by 9.3% (95% CI 5.6% to 12.9%), antibiotics DOT decrease on average by 3.2% (95% CI 1.0% to 5.4%) and expenditures on antibiotics decrease on average by 2.5% (95% CI 0.3% to 4.7%). The negative effect on antibiotic consumption is stronger in settlements where secondary care is less available, and where antibiotics were previously overprescribed. The quality of prescribing behaviour measured by the relative changes in the narrow-spectrum vs broad-spectrum as well as the Access versus Watch and Reserve antibiotics deteriorates significantly as a consequence of worse primary care availability.

Conclusions

Limited availability of primary care reduces the consumption of antibiotics and at the same time impairs the quality of prescriptions through a decrease of the number of doctor-patient encounters.

Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study

Por: McNeely · M. L. · Sellar · C. · Williamson · T. · Shea-Budgell · M. · Joy · A. A. · Lau · H. Y. · Easaw · J. C. · Murtha · A. D. · Vallance · J. · Courneya · K. · Mackey · J. R. · Parliament · M. · Culos-Reed · N.
Introduction

Cancer care has expanded from a disease-focused, survival-oriented model to an approach that now considers how survivors can live well in the aftermath of intensive therapy, where they may deal with significant changes to their bodies, mental health or emotional well-being. Research evidence supports the benefit of exercise during and following cancer treatments for cancer-related symptoms, physical functioning and fitness, and health-related quality of life. To move this efficacy evidence into practice, we designed and launched a 5-year study to evaluate the relative benefit from implementing a clinic-to-community-based cancer and exercise model of care.

Methods and analysis

A hybrid effectiveness and implementation trial design is being used to evaluate the effectiveness of delivery of community-based exercise and to collect data on implementation of the programme. The study opened in January 2017, with estimated completion by January 2022. The programme will be delivered in seven cities across the province of Alberta, Canada, with sites including three academic institutions, six YMCA locations, Wellspring Edmonton and Calgary, and six municipal fitness centres. Participants are adult cancer survivors (n=2500) from all tumour groups and stages and at any time point along their cancer treatment trajectory, up to 3 years post treatment completion. Survivors take part in a minimum of 60 min of mild-to-moderate intensity full body exercise twice weekly for a 12-week period. The primary effectiveness outcome is the proportion of participants meeting or exceeding 150 min of moderate intensity exercise per week at 1-year follow-up. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework will be utilised to capture individual-level and organizational-level impact of the exercise programme at 12 and 24 weeks and 1-year follow-up. The cohort of survivors participating in the study will allow for long-term (>5-year) evaluation of rates of cancer recurrence and secondary cancers beyond the funding period.

Ethics and dissemination

The study was approved by the Health Research Ethics Board of Alberta. The study is funded by Alberta Innovates and the Alberta Cancer Foundation. The study will help to answer critical questions on the effectiveness of cancer-specific community-based exercise programming in both the short-term and the long-term. Collectively, the findings will help to inform the acceptability, adoption, feasibility, reach and sustainability of community-based exercise.

Trial registration number

NCT02984163; Pre-results.

Effects of physical exercise during pregnancy on mothers and neonates health: a protocol for an umbrella review of systematic reviews and meta-analysis of randomised controlled trials

Introduction

A growing interest has emerged on the effects of exercise during gestation. Several systematic reviews and meta-analyses have shown that prenatal exercise could reduce the mothers’ risk for some disorders. Despite this, evidence regarding the risk of caesarean section, birth weight or Apgar score at delivery is still controversial. Furthermore, practitioners are reluctant to recommend exercise to pregnant women suffering from some disorders, such as hypertension, pre-eclampsia or pregnant women with obesity. Moreover, the scarcity of studies addressing the risks and benefits of exercise at higher intensity prevent practitioners from recommending it at higher dosages. Umbrella reviews represent an appropriate design to elucidate the reasons behind the contradictory findings of previous systematic reviews.

Methods

This protocol was developed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and the Cochrane Collaboration Handbook. Medline, EMBASE, Web of Science, Cochrane database of systematic reviews, Epistemonikos, Prospero register and SPORTDiscuss databases will be searched to identify systematic reviews, meta-analyses and randomised controlled trials that examine the effect of exercise on pregnancy outcomes from inception to August 2019. Searches will be conducted from September to November 2019.

Statistical analysis

Methodological quality will be evaluated using the AMSTAR 2 tool. The certainty of evidence and strength of recommendations for meta-analyses will be assessed by the Grading of Recommendations Assessment, Development and Evaluation framework. The summary effect sizes will be calculated through the use of random-effects and fixed-effects models. Heterogeneity among studies will be assessed using the I2 statistic, and evidence of excess significance bias and evidence of small study effects will also be evaluated.

Ethics and dissemination

Ethical approval will not be needed for this review protocol. The results will be disseminated to academic audiences by peer-reviewed publications. Furthermore, results will be disseminated to clinical audiences through professionals’ associations and social networks, and may influence guidelines developers in order to improve outcomes in mothers and offspring.

PROSPERO registration number

CRD42019123410.

The proximal hamstring avulsion clinical trial (PHACT)--a randomised controlled non-inferiority trial of operative versus non-operative treatment of proximal hamstrings avulsions: study protocol

Por: Pihl · E. · Kristoffersen · M. H. · Rosenlund · A.-M. · Laszlo · S. · Berglöf · M. · Ribom · E. · Eriksson · K. · Frihagen · F. · Mattila · V. M. · Schilcher · J. · Eklund · M. · Snellman · G. · Skorpil · M. · Sköldenberg · O. · Hedbeck · C. J. · Jonsson · K.
Introduction

The treatment of proximal hamstring avulsions is controversial. While several trials have investigated the outcome for patients treated surgically, there is today no prospective trial comparing operative treatment with non-operative treatment. This protocol describes the design for the proximal hamstring avulsion clinical trial (PHACT)—the first randomised controlled trial of operative versus non-operative treatment for proximal hamstring avulsions.

Methods and analysis

PHACT is a multicentre randomised controlled trial conducted across Sweden, Norway and Finland. Eligible patients (60 participants/treatment arm) with a proximal hamstring avulsion of at least two of three tendons will be randomised to either operative or non-operative treatment. Participants allocated to surgery will undergo reinsertion of the tendons with suture anchors. The rehabilitation programme will be the same for both treatment groups. When patient or surgeon equipoise for treatment alternatives cannot be reached and randomisation therefore is not possible, patients will be invited to participate in a parallel observational non-randomised cohort. The primary outcome will be the patient-reported outcome measure Perth hamstring assessment tool at 24 months. Secondary outcomes include the Lower Extremity Functional Score, physical performance and muscle strength tests, patient satisfaction and MR imaging. Data analysis will be blinded and intention-to-treat analysis will be preformed.

Ethics and dissemination

Ethical approval has been granted by the Ethical Committee of Uppsala University (DNR: 2017–170) and by the Norwegian ethical board (REC: 2017/1911). The study will be conducted in agreement with the Helsinki declaration. The findings will be disseminated in peer-reviewed publications.

Trial registration number

NCT03311997

Analgesic efficacy and safety of ketamine after total knee or hip arthroplasty: a meta-analysis of randomised placebo-controlled studies

Por: Xu · B. · Wang · Y. · Zeng · C. · Wei · J. · Li · J. · Wu · Z. · He · H. · Lei · G. · Xie · D. · Ding · X.
Objective

To examine the analgesic efficacy and safety of ketamine after total knee or hip arthroplasty.

Design

Systematic review and meta-analysis.

Data sources

PubMed, EMBASE and Cochrane Library from inception to 22 May 2019.

Eligibility criteria for selecting studies

Randomised controlled trials comparing the efficacy and safety of ketamine with placebo for postoperative pain relief in patients undergoing total knee or hip arthroplasty.

Data extraction and synthesis

Data (ie, pain intensity, morphine consumption, gastrointestinal and psychotic adverse effects) were extracted by two reviewers independently. The Cochrane Collaboration’s recommended tool was used to determine the methodological quality of included studies.

Results

A total of 10 studies were included. One of them was rated as low quality. Compared with placebo, intravenous ketamine was effective for pain relief during 0–8-hour (weighted mean difference (WMD) –1.21, 95% CI –1.45 to –0.98, p

Conclusions

Intravenous administration of ketamine is effective and safe for postoperative pain relief in patients undergoing total knee or hip arthroplasty. Nevertheless, the analgesic efficacy and safety of ketamine in such patients seem to vary by different administration routes and still warrant further studies to explore.

A randomised, controlled, observer-masked trial of corneal cross-linking for progressive keratoconus in children: the KERALINK protocol

Por: Chowdhury · K. · Dore · C. · Burr · J. M. · Bunce · C. · Raynor · M. · Edwards · M. · Larkin · D. F. P.
Introduction

The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients under 17 years old. KERALINK is a randomised controlled, observer-masked, multicentre trial in progressive keratoconus comparing epithelium-off CXL with standard care, including spectacles or contact lenses as necessary for best-corrected acuity.

Methods and analysis

A total of 30 participants will be randomised per group. Eligible participants aged 10–16 years with progressive keratoconus in one or both eyes will be recruited. Following randomisation, participants will be followed up 3-monthly for 18 months. The effect on progression will be determined by K2 on corneal topography. The primary outcome measure is between-group difference in K2 at 18 months adjusted for K2 at baseline examination. Secondary outcomes are the effect of CXL on (1) keratoconus progression, (2) time to keratoconus progression, (3) visual acuity, (4) refraction, (5) apical corneal thickness and (6) adverse events. Patient-reported effects will be explored by questionnaires.

Ethics and dissemination

Research Ethics Committee Approval was obtained on 30 June 2016 (ref: 14/LO/1937). Current protocol: V.5.0 (08/11/2017). Study findings will be published in peer-reviewed journals.

Trial registration number

European Union clinial trials register (EudraCT) 2016-001460-11

Perspective of asylum-seeking caregivers on the quality of care provided by a Swiss paediatric hospital: a qualitative study

Por: Brandenberger · J. · Sontag · K. · Duchene-Lacroix · C. · Jaeger · F. N. · Peterhans · B. · Ritz · N.
Objectives

This study investigated the perspective of asylum-seeking caregivers on the quality of healthcare delivered to their children in a qualitative in-depth interview study. The health of asylum-seeking children is of key interest for healthcare providers, yet knowledge of the perspective of asylum-seeking caregivers when accessing healthcare is limited.

Setting

The study took place in a paediatric tertiary care hospital in Basel, Switzerland.

Participants

Interviews were done with 13 asylum-seeking caregivers who had presented with their children at the paediatric tertiary care hospital. Nine female and four male caregivers from Tibet, Eritrea, Afghanistan, Syria, Iraq, Albania and Macedonia were included. A diverse sample was chosen regarding cultural and social background, years of residence in Switzerland and reasons for seeking care. A previously developed and pilot-tested interview guide was used for semistructured in-depth interviews between 36 and 92 min in duration. Data analysis and reporting was done according to Consolidated Criteria for Reporting Qualitative Research. The number of interviews was determined by saturation of data.

Results

The interviewees described a mismatch of personal competencies and external challenges. Communication barriers and unfamiliarity with new health concepts were reported as challenges. These were aggravated by isolation and concerns about their child’s health. The following factors were reported to strongly contribute to satisfaction of healthcare delivery: a respectful and trusting caregiver–provider relationship, the presence of interpreters and immediate availability of treatment.

Conclusions

A mismatch of personal competencies and external challenges importantly influences the caregiver–provider relationship. To overcome this mismatch establishment of confidence was identified as a key factor. This can be achieved by availability of interpreter services, sufficient consultation time and transcultural trainings for healthcare workers. Coordination between the family, the government’s asylum system and the medical system is required to facilitate this process.

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