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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.

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.

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.

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.

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

The impact of decision aids in patients with colorectal cancer: a systematic review

Por: Goldwag · J. · Marsicovetere · P. · Scalia · P. · Johnson · H. A. · Durand · M.-A. · Elwyn · G. · Ivatury · S. J.
Objectives

Our aim was to conduct a systematic review of the literature to determine the impact of patient decision aids (PDA) on patients facing treatment decisions for colorectal cancer.

Design

Systematic review.

Data sources

Sources included Embase, Medline, Web of Science, CINAHL and the Cochrane Library from inception to June, 20, 2019.

Eligibility criteria

We included randomised controlled trials (RCTs), cohort studies, mixed methods and case series in which a PDA for colorectal cancer treatment was used. Qualitative studies were excluded from our review.

Data extraction and synthesis

Following execution of the search strategy by a medical librarian, two blinded independent reviewers identified articles for inclusion. Two blinded reviewers were also responsible for data extraction, risk of bias and study quality assessments. Any conflict in article inclusion or extraction was resolved by discussion.

Results

Out of 3773 articles identified, three met our inclusion criteria: one RCT, one before-and-after study and one mixed-method study. In these studies, the use of a PDA for colorectal cancer treatment was associated with increased patient knowledge, satisfaction and preparation for making a decision. On quality assessment, two of three studies were judged to be of low quality.

Conclusion

A paucity of evidence exists on the effect of PDA for colorectal cancer treatment with existing evidence being largely of low quality. Further investigation is required to determine the effect of decision aids for colorectal cancer treatment as well as reasons for the lack of PDA development and implementation in this area.

Prospero registration number

CRD42018095153.

Development of reporting guidance and core outcome sets for seamless, standardised evaluation of innovative surgical procedures and devices: a study protocol for content generation and a Delphi consensus process (COHESIVE study)

Por: Avery · K. · Blazeby · J. · Wilson · N. · Macefield · R. · Cousins · S. · Main · B. · Blencowe · N. S. · Zahra · J. · Elliott · D. · Hinchliffe · R. · Potter · S.
Introduction

Rigorous evaluation of innovative invasive procedures and medical devices is uncommon and lacks reporting standardisation. Devices may therefore enter routine practice without thorough evaluation, resulting in patient harm. Detailed guidance on how to select and report outcomes at each stage of evaluation is lacking. Development of reporting guidance and core outcome sets (COS) is one strategy to promote safe and transparent evaluation.

Methods and analysis

A COS, comprising outcome domains applicable to all phases of evaluation of procedure/device introduction and modification and, if necessary, supplementary domains relevant to specific phases or types of innovation (procedure or device), will be developed according to principles outlined by Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development (COS-STAD) guidelines. Reporting guidance will be developed concurrently. The study will have the following three phases:

1. Generation of a list of relevant outcome domains and reporting items identified from (a) published studies, (b) hospital policy documentation, (c) regulatory body documentation and (d) stakeholder qualitative interviews. Identified items/domains will be categorised using a conceptual framework and formatted into Delphi consensus survey questionnaire items.

2. Key stakeholders, including 50 patients and 150 professionals (surgeons, researchers, device manufacturers, regulatory representatives, journal editors) sampled from multinational sources, will complete a Delphi survey to score the importance of each reporting item and outcome.

3. A consensus meeting with key stakeholders will discuss and agree the final content of the reporting guidance and COS(s).

Ethics and dissemination

Ethical approval has been granted by North East-Newcastle and North Tyneside 1 Health Research Authority Research Ethics Committee (18/NE/0378). Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, development of plain English summaries/materials, patient engagement events, development of a social media identity, workshops and other events.

Oral health of high-cost patients and evaluation of oral health measures as predictors for high-cost patients in South Korea: a population-based cohort study

Por: Kim · Y. J.
Objective

To examine the oral health conditions and oral health behaviour of high-cost patients and evaluate oral health measures as predictors of future high-cost patients.

Design

A retrospective, population-based cohort study using administrative healthcare records.

Setting

The National Health Insurance Service (NHIS) medical check-up database (a.k.a. NHIS—national health screening cohort database) in South Korea.

Participants

131 549 individuals who received biennial health check-ups including dental check-ups in 2011 or 2012, aged 49–88.

Primary outcome measures

Current and subsequent year high-cost patient status.

Results

High-cost patients, on average, incur higher dental costs, suffer more from periodontal disease, brush their teeth less and use secondary oral hygiene products less. Some of the self-reported oral health behaviours and oral symptom variables show statistically significant associations with subsequent year high-cost patient indicators, even after adjusting for demographic, socioeconomic, medical conditions, and prior healthcare cost and utilisation.

Conclusions

We demonstrate that oral health measures are associated with an increased risk of becoming a high-cost patient.

Study protocol for a single-blind randomised controlled trial to evaluate the clinical effects of an Integrated Qigong exercise intervention on freezing of gait in Parkinsons disease

Por: Li · Z. · Zhuang · J. · Jiang · Y. · Xiao · G. · Jie · K. · Wang · T. · Yin · W. · Zhang · Y. · Wang · Z.
Introduction

Qigong exercise offers a potentially safe, low-cost and effective mind–body rehabilitative intervention for mitigating the problem of gait interruption among patients with Parkinson’s disease (PD) who have frequent freezing of gait (FOG) episodes. However, its clinical effects have not been established. This paper describes the trial protocol of evaluating the clinical efficacy of a newly developed Integrated Qigong in improving gait among patients with PD who have FOG.

Methods and analysis

A single-blind randomised controlled trial is designed to compare Integrated Qigong and balance training with an attention control. Participants will be patients with mild to moderate PD who experience FOG and are recruited from local communities in Shanghai, China. Participants will be randomly allocated to one of the three groups: Integrated Qigong group, a balance exercise intervention group, or control group. The total number of participants will be 126, and masked assessments will be made at baseline, 12 weeks (end of intervention) and 12-week follow-up. Both Integrated Qigong group and balance training group will receive a group-based exercise intervention that meets three times per week, 60 min in duration, for 12 weeks. The control group will receive a 60 min weekly group session and monthly health education. The primary outcomes are gait parameters (stride length, gait velocity, stride time variability) and occurrence of FOG. The secondary outcomes are postural instability, walking disability, falling, fear of falling and quality of life.

Ethics and dissemination

This study has been approved by the Ethics Committee of Shanghai University of Sport and registered at China Clinical Trial Registry. Participants will sign informed consent prior to the participation of the trial. The findings of the study will be published in peer-reviewed academic journals and disseminated to PD support groups, medical community and media.

Trial registration number

ChiCTR1800016570.

How do GPs and patients share the responsibility for cancer safety netting follow-up actions? A qualitative interview study of GPs and patients in Oxfordshire, UK

Por: Evans · J. · Macartney · J. I. · Bankhead · C. · Albury · C. · Jones · D. · Ziebland · S. · Nicholson · B. D.
Objective

To explore patients’ and General Practitioners' (GPs) accounts of how responsibility for follow-up was perceived and shared in their experiences of cancer safety netting occurring within the past 6 months.

Design

In-depth interviews were recorded and transcribed verbatim. Data were analysed through an abductive process, exploring anticipated and emergent themes. Conceptualisations of ‘responsibility’ were explored by drawing on a transactional to interdependent continuum drawing from the shared decision-making literature.

Settings and participants

A purposive sample of 25 qualified GPs and 23 adult patients in Oxfordshire, UK.

Results

The transactional sharing approach involves responsibility being passed from GP to patient. Patients expected and were willing to accept responsibility in this way as long as they received clear guidance from their GP and had capacity. In interdependent sharing, GPs principally aimed to reach consensus and share responsibility with the patient by explaining their rationale, uncertainty or by stressing the potential seriousness of the situation. Patients sharing this responsibility could be put at risk if no follow-up or timeframe was suggested, they had inadequate information, were falsely reassured or their concerns were not addressed at re-consultation.

Conclusion

GPs and patients exchange and share responsibility using a combination of transactional and interdependent styles, tailoring information based on patient characteristics and each party’s level of concern. Clear action plans (written where necessary) at the end of every consultation would help patients decide when to re-consult. Further research should investigate how responsibility is shared within and outside the consultation, within primary care teams and with specialist services.

Methotrimeprazine versus haloperidol in palliative care patients with cancer-related nausea: a randomised, double-blind controlled trial

Por: Hardy · J. R. · Skerman · H. · Philip · J. · Good · P. · Currow · D. C. · Mitchell · G. · Yates · P.
Objectives

Methotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.

Design

Double-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.

Setting

11 palliative care sites in Australia.

Participants

Participants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.

Interventions

Based on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.

Main outcome measures

A ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.

Results

Response to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In the per protocol analysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Complete per protocol response rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.

Conclusion

This study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.

Trial registration number

ACTRN 12615000177550.

Developing a cerebral palsy-specific preference-based measure for a six-dimensional classification system (CP-6D): protocol for a valuation study

Por: Bahrampour · M. · Norman · R. · Byrnes · J. · Downes · M. · Scuffham · P. A.
Introduction

Cerebral palsy (CP) is a lifelong condition. The CP quality of life (CPQOL) instrument is a frequently used disease-specific instrument to assess health-related quality of life (HRQoL) in people with CP, but it cannot be used to generate quality-adjusted life years (QALY) which are the basis of cost utility analysis (CUA). Generic utility instruments (such as the EQ-5D or SF-6D) that are used to value HRQOL may be insensitive to small but important health changes in children with CP. This study aims to generate a preference-based scoring algorithm for the CP six dimensions (CP-6D), a classification system developed from the CPQOL.

Methods and analysis

A discrete choice experiment with duration (DCEtto) will be administrated to value health states described by the CP-6D classification system. These health states will be presented to members of Australian general population and parents of children with CP via an online survey. Conditional logit regression will be used to produce the utility algorithm for CP-6D.

Ethics and dissemination

The Griffith University Human Research Ethics Committee approved for the study (reference HREC/number 2018/913). The developed algorithm can be applied to previous and future economic evaluation of interventions and treatments targeting people with CP which have used either the CPQOL or CP-6D.

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