bluuebunny/crossref_metadata_2025 huggingface dataset:
Outcomes of lensectomy and risk factors for failure in spherophakic eyes with secondary glaucoma
Authors: Rao Divya P , John Praveen J , Ali Mohammed Hasnat , Kekunnaya Ramesh , Jalali Subhadra , Garudadri Chandra Sekhar , Senthil Sirisha
Published: September 2017

Purpose

To report the outcomes of lensectomy in spherophakic eyes with subluxated or dislocated crystalline lenses and secondary glaucoma.

Methods

Lensectomy was performed in 52 eyes, 36 eyes with lens subluxation and 16 eyes with lens dislocation with secondary glaucoma from 1991 to 2016. Glaucoma was diagnosed based on intraocular pressure (IOP) ≥22 mm Hg and/or glaucomatous optic disc damage. Complete success was defined as IOP ≥5 and ≤21 mm Hg without antiglaucoma medications (AGMs) or surgery, and eyes needing oral AGM or surgical intervention for IOP control or those with complication causing loss of light perception were considered failure.

Results

Median (IQR) age at lensectomy was 12 (6–18) years, and median spherical equivalent was −14.5D (−23.7to −13). Median follow-up was 30.6 (5.4–103.4) months. Median logMAR (logarithm of minimal angle of resolution) visual acuity improved from 0.95 (0.6–1.8) to 0.4 (0.2–1.3) after lensectomy (p=0.01). Median IOP decreased from 22 mm Hg (17–31) to 14 mm Hg (11–19) at final follow-up (p=0.01). Median number of AGM decreased from 2 (2–3) to 1 (0–2) at final follow-up (p<0.0001), and glaucoma surgery was needed in four eyes (7.7% eyes). Complete success probability was 69% at 1 year and 51% at 5 years. Younger age (<6 years), higher presenting IOP (>32 mm Hg) and larger cup to disc ratio at presentation were found to be significant risk factors for failure.

Conclusion

Lensectomy was effective in controlling IOP in close to half of all eyes with spherophakia and secondary glaucoma, 40% eyes needed AGM and only 7.7% eyes needed glaucoma surgery for IOP control. In this cohort, younger age, higher IOP and larger cup to disc ratio at presentation were risk factors for poor glaucoma control after lensectomy.
Replacement of warfarin with a novel oral anticoagulant in endoscopic mucosal resection: a multicentre, open-label, randomised controlled trial
Authors: Yamada Takuya , Kada Akiko , Uraoka Toshio , Kuwai Toshio , Watanabe Noriko , Sasaki Yoshihiro , Mabe Katsuhiro , Takahashi Yasuo , Kagaya Takashi , Kimura Toshihisa , Hamada Hiroshige , Saito Akiko M , Harada Naohiko
Published: September 2017

Introduction

This randomised controlled trial aims to compare the efficacy of warfarin replacement with apixaban without postoperative resumption of heparin with that of conventional heparin bridging in patients taking warfarin and scheduled to undergo endoscopic mucosal resection (EMR): specifically, by checking for reduction in proportion of postoperative bleeding following EMR.

Methods and analysis

The multicentre, open-label randomised parallel-group, controlled intervention study regards patients taking warfarin who are scheduled to undergo colon EMR. Enrolled patients have been taking oral warfarin for non-valvular atrial fibrillation or venous thrombosis on an outpatient basis, and have been found to have a colorectal polyp (including adenoma or early-stage cancer) for which EMR was indicated. They are assigned to one of two groups.

The primary endpoint is proportion of postoperative bleeding. The secondary endpoints are hospital stay length, therapeutic endoscopy outcomes such as proportion of en bloc resection, proportion of perforation, proportion of intraoperative bleeding, incidence of cerebral infarction/systemic embolism events, incidence of adverse events and serious adverse events, and proportion of postoperative therapeutic endoscopy.

Ethics and dissemination

This trial was approved by the National Hospital Organization Central Review Board for Clinical Trials (19 April 2016).

Discussion

The paucity of reports with high evidence levels was considered problematic when the Japan Gastroenterological Endoscopy Society’s gastroenterological endoscopy guidelines were revised in 2012. The results of this trial will have high medical significance, as its data could serve as the basis for revisions in the next edition of the guidelines.

Trial registration number

This trial was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) accepted from the International Committee of Medical Journal Editors (ICMJE). UMIN000021947; Pre-results.
How income and food prices influence global dietary intakes by age and sex: evidence from 164 countries
Authors: Muhammad Andrew , D’Souza Anna , Meade Birgit , Micha Renata , Mozaffarian Dariush
Published: September 2017

Background

While income and prices are key drivers of dietary choices, how their influence varies by food category, nation, and demographics is not well established. Based on intake data for 164 countries and 11 food categories, we examined how income and food prices relate to food intake globally, including by world region, age, and sex.

Methods

We used 2010 intake data from the Global Dietary Database, the first database of consumption estimates for major food categories by country, age, and sex. We combined these data with national per capita GDP and food price data. We estimated intake responsiveness to income and prices for each food category, accounting for differences by national income, world region, age, and sex.

Results

We identified several differences in intake responsiveness. For example, rising income was estimated to increase milk intake most strongly in Sub-Saharan Africa and fruit intake most strongly among older women globally. Comparing our intake results to previous findings based on expenditure data, we found more goods that exhibited declining intake in response to rising incomes, fewer significant relationships for a number of food categories, particularly for higher income regions, and whereas in prior studies, elasticities mostly decrease with national income, we identified food categories where this was not the case.

Conclusion

The results of this study show heterogeneous associations among income, prices, and food intakes. Policymakers should consider the price and income elasticities of certain foods, as well as the role of demographics within and across countries, as they address global nutrition and health challenges.
Does this treatment work for me? The patient’s role in assessing medical care
Authors: Neuhauser Duncan V , Chu Jennifer
Published: September 2017

Randomised clinical trials are designed to determine whether a particular treatment is appropriate to make a significant difference to the health of a defined population and to aid its approval for use. For an accurate, cheap and simple assessment to see if a treatment benefits an individual person, all that is needed is a pen, paper, simple pocket calculator and daily recording of a few variables. It requires the ability to read and write and to understand addition and division. Factorial design of experiments is used to show the impact of several variables and their interaction on the person’s health status. An example of a 75-year-old man with an enlarged prostate is used here to illustrate this approach. This person was able to understand and reduce side effects, lower the costs of medication by 83% and improve measured health status by 28%. A multivariate model for this person was then created with about 450 person-days of data.
Cohort profile of a study on outcomes related to tuberculosis and antiretroviral drug concentrations in Uganda: design, methods and patient characteristics of the SOUTH study
Authors: Sekaggya-Wiltshire Christine , Castelnuovo Barbara , von Braun Amrei , Musaazi Joseph , Muller Daniel , Buzibye Allan , Gutteck Ursula , Henning Lars , Ledergerber Bruno , Corti Natascia , Lamorde Mohammed , Fehr Jan , Kambugu Andrew
Published: September 2017

Purpose

Tuberculosis (TB) is a leading cause of death among people living with HIV in sub-Saharan Africa. Several factors influence the efficacy of TB treatment by leading to suboptimal drug concentrations and subsequently affecting treatment outcome. The aim of this cohort is to determine the association between anti-TB drug concentrations and TB treatment outcomes.

Participants

Patients diagnosed with new pulmonary TB at the integrated TB-HIV outpatient clinic in Kampala, Uganda, were enrolled into the study and started on first-line anti-TB treatment.

Findings to date

Between April 2013 and April 2015, the cohort enrolled 268 patients coinfected with TB/HIV ; 57.8% are male with a median age of 34 years (IQR 29–40). The median time between the diagnosis of HIV and the diagnosis of TB is 2 months (IQR 0–22.5). The majority of the patients are antiretroviral therapy naive (75.4%). Our population is severely immunosuppressed with a median CD4 cell count at enrolment of 163 cells/µL (IQR 46–298). Ninety-nine per cent of the patients had a diagnosis of pulmonary TB confirmed by sputum microscopy, Xpert/RIF or culture and 203 (75.7%) have completed TB treatment with 5099 aliquots of blood collected for pharmacokinetic analysis.

Future plans

This cohort provides a large database of well-characterised patients coinfected with TB/HIV which will facilitate the description of the association between serum drug concentrations and TB treatment outcomes as well as provide a research platform for future substudies including evaluation of virological outcomes.

Trial registration number

NCT01782950; Pre-results.
Burden of non-adherence to latent tuberculosis infection drug therapy and the potential cost-effectiveness of adherence interventions in Canada: a simulation study
Authors: Patel Anik R , Campbell Jonathon R , Sadatsafavi Mohsen , Marra Fawziah , Johnston James C , Smillie Kirsten , Lester Richard T
Published: September 2017

Objective

Pharmaceutical treatment of latent tuberculosis infection (LTBI) reduces the risk of progression to active tuberculosis (TB); however, poor adherence tempers the protective effect. We aimed to estimate the health burden of non-adherence, the maximum allowable cost of hypothetical new adherence interventions to be cost-effective and the potential value of existing adherence interventions for patients with low-risk LTBI in Canada.

Design

A microsimulation model of LTBI progression over 25 years.

Setting

General practice in Canada.

Participants

Individuals with LTBI who are initiating drug therapy.

Interventions

A hypothetical intervention with a range of effectiveness was evaluated. Existing drug adherence interventions including peer support, two-way text messaging support, enhanced adherence counselling and adherence incentives were also evaluated.

Primary and secondary outcome measures

Simulation outcomes included healthcare costs, TB incidence, TB deaths and quality-adjusted life years (QALYs). Base case results were interpreted against a willingness-to-pay threshold of $C50 000/QALY.

Results

Compared with current adherence levels, full adherence to LTBI drug therapy could reduce new TB cases from 90.3 cases per 100 000 person-years to 35.9 cases per 100 000 person-years and reduce TB-related deaths from 7.9 deaths per 100 000 person-years to 3.1 deaths per 100 000 person-years. An intervention that increases relative adherence by 40% would bring the population near full adherence to drug therapy and could have a maximum allowable annual cost of approximately $C450 per person to be cost-effective. Based on estimates of effect sizes and costs of existing adherence interventions, we found that they yielded between 900 and 2400 additional QALYs per million people, reduced TB deaths by 5%–25% and were likely to be cost-effective over 25 years.

Conclusion

Full adherence could reduce the number of future TB cases by nearly 60%, offsetting TB-related costs and health burden. Several existing interventions are could be cost-effective to help achieve this goal.
Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial
Authors: Al-Itejawi Hoda H M , van Uden-Kraan Cornelia F , van de Ven Peter M , Coupé Veerle M H , Vis André N , Nieuwenhuijzen Jakko A , van Moorselaar Jeroen A , Verdonck-de Leeuw Irma M
Published: September 2017

Introduction

Patient decision aids (PDAs) have been developed to help patients make an informed choice for a treatment option. Despite proven benefits, structural implementation falls short of expectations. The present study aims to assess the effectiveness and cost-utility of the PDA among newly diagnosed patients with localised prostate cancer and their partners, alongside implementation of the PDA in routine care.

Methods/analysis

A stepped-wedge cluster randomised trial will be conducted. The PDA will be sequentially implemented in 18 hospitals in the Netherlands, over a period of 24 months. Every 3 or 6 months, a new cluster of hospitals will switch from usual care to care including a PDA.

The primary outcome measure is decisional conflict experienced by the patient. Secondary outcomes comprise the patient’s quality of life, treatment preferences, role in the decision making, expectations of treatment, knowledge, need for supportive care and decision regret. Furthermore, societal cost-utility will be valued. Other outcome measures considered are the partner’s treatment preferences, experienced participation to decision making, quality of life, communication between patient, partner and health care professional, and the effect of prostate cancer on the relationship, social contacts and their role as caregiver. Patients and partners receiving the PDA will also be asked about their satisfaction with the PDA.

Baseline assessment takes place after the treatment choice and before the start of a treatment, with follow-up assessments at 3, 6 and 12 months following the end of treatment or the day after deciding on active surveillance. Outcome measures on implementation include the implementation rate (defined as the proportion of all eligible patients who will receive a PDA) and a questionnaire for health care professionals on determinants of implementing an innovation.

Ethics and dissemination

This study will be conducted in accordance with local laws and regulations of the Medical Ethics Committee of VU University Medical Center, Amsterdam, The Netherlands. The results from this stepped-wedge trial will be presented at scientific meetings and published in peer-reviewed journals.

Trial registration

Nederlands Trial Register NTR TC5177, registration date: May 28th2015.Pre-results.
Qualitative interview study of parents’ perspectives, concerns and experiences of the management of lower respiratory tract infections in children in primary care
Authors: Halls Amy , van’t Hoff Catherine , Little Paul , Verheij Theo , Leydon Geraldine M
Published: September 2017

Objective

To explore parents’ perspectives, concerns and experiences of the management of lower respiratory tract infections (LRTIs) in children in primary care.

Design

Qualitative semistructured interview study.

Setting

UK primary care.

Participants

23 parents of children aged 6 months to 10 years presenting with LRTI in primary care.

Method

Thematic analysis of semistructured interviews (either in person or by telephone) conducted with parents to explore their experiences and views on their children being prescribed antibiotics for LRTI.

Results

Four major themes were identified and these are perspectives on: (1) infection, (2) antibiotic use, (3) the general practitioner (GP) appointment and (4) decision making around prescribing. Symptomatic relief was a key concern: the most troublesome symptoms were cough, breathing difficulty, fever and malaise. Many parents were reluctant to use self-care medication, tended to support antibiotic use and believed they are effective for symptoms, illness duration and for preventing complications. However, parental expectations varied from a desire for reassurance and advice to an explicit preference for an antibiotic prescription. These preferences were shaped by: (1) the age of the child, with younger children perceived as more vulnerable because of their greater difficulty in communicating, and concerns about rapid deterioration; (2) the perceived severity of the illness; and (3) disruption to daily routine. When there was disagreement with the GP, parents described feeling dismissed, and they were critical of inconsistent prescribing when they reconsult. When agreement between the parent and the doctor featured, parents described a feeling of relief and legitimation for consulting, feeling reassured that the illness did indeed warrant a doctor’s attention.

Conclusion

Symptomatic relief is a major concern for parents. Careful exploration of expectations, and eliciting worries about key symptoms and impact on daily life will be needed to help parents understand when a no antibiotic recommendation or delayed antibiotic recommendation is made.
‘Just like a normal pain’, what do people with diabetes mellitus experience when having a myocardial infarction: a qualitative study recruited from UK hospitals
Authors: Berman Nikita , Jones Melvyn Mark , De Coster Daan A
Published: September 2017

Objective

The objective of the study was to investigate the symptoms people with diabetes experience when having a myocardial infarction (MI), their illness narrative and how they present their symptoms to the health service.

Setting

Three London (UK) hospitals (coronary care units and medical wards).

Participants

Patients were recruited with diabetes mellitus (DM) (types 1 and 2) with a clinical presentation of MI (ST elevated MI (STEMI), non-ST elevated MI (NSTEMI), acute MI unspecified and cardiac arrest). A total of 43 participants were recruited, and 39 interviews met the study criteria and were analysed. They were predominantly male (n=30), aged 40–90 years and white British (18/39), and just over a half were from other ethnic groups. The majority had type 2 DM (n=35), 24 had an NSTEMI, 10 had an STEMI and five had other cardiac events.

Definitions of selection/exclusion criteria

A diagnosis of MI and DM and the ability to communicate enough English to complete the interview. Ward staff made a clinical judgement that the participant was post-treatment, clinically stable and well enough to participate.

Methods

A qualitative study using taped and transcribed interviews analysed using a thematic analysis.

Results

While most participants did experience chest pain, it was often not their most striking symptom. As their chest pain did not match their expectations of what a ‘heart attack’ should be, participants developed narratives to explain these symptoms, including the symptoms being effects of their DM (‘hypos’), side effects of medication (oral hypoglycaemics) or symptoms (such as breathlessness and indigestion) related to other comorbidities, often leading to delays in seeking care.

Conclusions

While truly absent chest pain during MI among people with DM was rare in this study, patients’ attenuated symptoms often led to delay in seeking attention, and this may result in delays in receiving treatment.
Gender differences in longevity in free-living older adults who eat-with-others: a prospective study in Taiwan
Authors: Huang Yi-Chen , Cheng Hsing-Ling , Wahlqvist Mark L , Lo Yuan-Ting C , Lee Meei-Shyuan
Published: September 2017

Objectives

Social activities such as ‘eating-with-others’ can positively affect the ageing process. We investigated the gender-specific association between eating arrangements and risk of all-cause mortality among free-living older adults.

Setting

A representative sample from the Elderly Nutrition and Health Survey in Taiwan during 1999–2000.

Participants

Some 1894 participants (955 men and 939 women) who aged ≥65 and completed eating arrangement question as well as confirmed survivorship information.

Primary and secondary outcome measures

Eating arrangements, health condition and 24-hour dietary recall information were collected at baseline. We classified eating arrangements as the daily frequency of eating-with-others (0–3). Survivorship was determined by the National Death Registry until the end of 2008. Cox proportional-hazards regression was used to assess the association between eating-with-others and mortality risk.

Results

Overall, 63.1% of men and 56.4% of women ate with others three times a day. Both men and women who ate with others were more likely to have higher meat and vegetable intakes and greater dietary quality than those who ate alone. The HRs (95% CI) for all-cause mortality when eating-with-others two and three times per day were 0.42 (0.28 to 0.61), 0.67 (0.52 to 0.88) in men and 0.68 (0.42 to 1.11), 0.86 (0.64 to 1.16) in women, compared with those who ate alone. Multivariable HRs (95% CI) adjusted for sociodemographic, nutritional and ‘activities of daily living’ covariates were 0.43 (0.25 to 0.73), 0.63 (0.41 to 0.98) in men and 0.68 (0.35 to 1.30), 0.69 (0.39 to 1.21) in women. With further adjustment for financial status, HR was reduced by 54% in men who ate with others two times a day. Pathway analysis shows this to be dependent on improved dietary quality by eating-with-others.

Conclusions

Eating-with-others is an independent survival factor in older men. Providing a social environment which encourages eating-with-others may benefit survival of older people, especially for men.
Combining CD4 recovery and CD4: CD8 ratio restoration as an indicator for evaluating the outcome of continued antiretroviral therapy: an observational cohort study
Authors: Lee Shui Shan , Wong Ngai Sze , Wong Bonnie Chun Kwan , Wong Ka Hing , Chan Kenny Chi Wai
Published: September 2017

Objectives

Immune recovery following highly active antiretroviral therapy (HAART) is commonly assessed by the degree of CD4 reconstitution alone. In this study, we aimed to assess immune recovery by incorporating both CD4 count and CD4:CD8 ratio.

Design

Observational cohort study

Setting and participants

Clinical data from Chinese HIV-positive patients attending the largest HIV service in Hong Kong and who had been on HAART for ≥4 years were accessed.

Main outcome measures

Optimal immune outcome was defined as a combination of a CD4 count ≥500/μL and a CD4:CD8 ratio ≥0.8.

Results

A total of 718 patients were included for analysis (6353 person-years). At the end of year 4, 318 out of 715 patients achieved CD4 ≥500/μL, of which only 33% (105 out of 318) concurrently achieved CD4:CD8 ratio ≥0.8. Patients with a pre-HAART CD8 ≤800/μL (428 out of 704) were more likely to be optimal immune outcome achievers with CD4 ≥500/μL and CD4:CD8 ratio ≥0.8, the association of which was stronger after adjusting for pre-HAART CD4 counts. In a multivariable logistic model, optimal immune outcome was positively associated with male gender, younger pre-HAART age and higher pre-HAART CD4 count, longer duration of HAART and pre-HAART CD8 ≤800/μL. Treatment regimen and cumulative viral loads played no significant role in the pattern of immune recovery.

Conclusions

A combination of CD4 count and CD4:CD8 ratio could be a useful approach for the characterisation of treatment outcome over time, on top of monitoring CD4 count alone.
The course and prognostic factors of cognitive status after central nervous system trauma: a systematic review protocol
Authors: Mollayeva Tatyana , Pacheco Nicole , D’Souza Andrea , Colantonio Angela
Published: September 2017

Introduction

Traumatic brain injury (TBI) is among the most disabling injuries, resulting in a range of cognitive impairments. Traumatic spinal cord injury (SCI) often occurs in conjunction with TBI; the two are best considered together in the context of trauma to the central nervous system (CNS). Despite strong indications of cognitive dysfunction in CNS trauma, little is known about its natural history or relationship with other factors. The current protocol outlines a strategy for a systematic review of the current evidence examining CNS trauma as a prognostic factor of cognitive decline in the adult population.

Methods and analysis

The review will be conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All peer-reviewed English language publications with a longitudinal design that focus on cognition in adults (ages 18 and older) with either TBI or SCI, or both from inception to December 2016 found through Medline, Central, Embase, Scopus, PsycINFO, supplemental PubMed and bibliographies of identified articles will be considered eligible. Quality will be evaluated using published guidelines. Results will be grouped by: (1) prognostic factors of cognitive deficits; and (2) development of, or time until development of, cognitive deficit in patients with CNS trauma. Close attention will be paid to the evaluative properties of the measurements used to assess cognition.

Ethics and dissemination

The authors will publish findings from this review in a peer-reviewed scientific journal(s) and present the results at national and international conferences. This work will advance scientific certainty regarding natural history and prognostic factors of cognitive status in males and females with CNS trauma, informing clinicians, policymakers and future researchers on the topic.

PROSPERO registration number

CRD42017055309.
Prediction of early unplanned intensive care unit readmission in a UK tertiary care hospital: a cross-sectional machine learning approach
Authors: Desautels Thomas , Das Ritankar , Calvert Jacob , Trivedi Monica , Summers Charlotte , Wales David J , Ercole Ari
Published: September 2017

Objectives

Unplanned readmissions to the intensive care unit (ICU) are highly undesirable, increasing variance in care, making resource planning difficult and potentially increasing length of stay and mortality in some settings. Identifying patients who are likely to suffer unplanned ICU readmission could reduce the frequency of this adverse event.

Setting

A single academic, tertiary care hospital in the UK.

Participants

A set of 3326 ICU episodes collected between October 2014 and August 2016. All records were of patients who visited an ICU at some point during their stay. We excluded patients who were ≤16 years of age; visited ICUs other than the general and neurosciences ICU; were missing crucial electronic patient record measurements; or had indeterminate ICU discharge outcomes or very early or extremely late discharge times. After exclusion, 2018 outcome-labelled episodes remained.

Primary and secondary outcome measures

Area under the receiver operating characteristic curve (AUROC) for prediction of unplanned ICU readmission or in-hospital death within 48 hours of first ICU discharge.

Results

In 10-fold cross-validation, an ensemble predictor was trained on data from both the target hospital and the Medical Information Mart for Intensive Care (MIMIC-III) database and tested on the target hospital’s data. This predictor discriminated between patients with the unplanned ICU readmission or death outcome and those without this outcome, attaining mean AUROC of 0.7095 (SE 0.0260), superior to the purpose-built Stability and Workload Index for Transfer (SWIFT) score (AUROC=0.6082, SE 0.0249; p=0.014, pairwise t-test).

Conclusions

Despite the inherent difficulties, we demonstrate that a novel machine learning algorithm based on transfer learning could achieve good discrimination, over and above that of the treating clinicians or the value added by the SWIFT score. Accurate prediction of unplanned readmission could be used to target resources more efficiently.
A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials
Authors: Chauvin Anthony , Moher David , Altman Doug , Schriger David L , Alam Sabina , Hopewell Sally , Shanahan Daniel R , Recchioni Alessandro , Ravaud Philippe , Boutron Isabelle
Published: September 2017

Introduction

Systematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to compare the accuracy of early career peer reviewers who use an innovative online tool to the usual peer reviewer process in evaluating the completeness of reporting and switched primary outcomes in completed reports.

Methods and analysis

This is a cross-sectional study of individual two-arm parallel-group randomised controlled trials (RCTs) published in the BioMed Central series medical journals,BMJ,BMJ OpenandAnnals of Emergency Medicineand indexed with the publication type ‘Randomised Controlled Trial’. First, we will develop an online tool and training module based (a) on the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the Explanation and Elaboration document that would be dedicated to junior peer reviewers for assessing the completeness of reporting of key items and (b) the Centre for Evidence-Based Medicine Outcome Monitoring Project process used to identify switched outcomes in completed reports of the primary results of RCTs when initially submitted. Then, we will compare the performance of early career peer reviewers who use the online tool to the usual peer review process in identifying inadequate reporting and switched outcomes in completed reports of RCTs at initial journal submission. The primary outcome will be the mean number of items accurately classified per manuscript. The secondary outcomes will be the mean number of items accurately classified per manuscript for the CONSORT items and the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify a switch in outcomes. We aim to include 120 RCTs and 120 early career peer reviewers.

Ethics and dissemination

The research protocol was approved by the ethics committee of the INSERM Institutional Review Board (21 January 2016). The study is based on voluntary participation and informed written consent.

Trial registration number

NCT03119376.
Treatment options and barriers to case management of neonatal pneumonia in India: a protocol for a scoping review
Authors: Nair N Sreekumaran , Lewis Leslie Edward , Murthy Shruti , Godinho Myron Anthony , Lakiang Theophilus , Venkatesh Bhumika T
Published: September 2017

Introduction

India contributes to the highest neonatal deaths globally. Case management is said to be the cornerstone of pneumonia control. Much of the published evidence focuses on children aged 1 to 59 months. This scoping review, thus, aims to identify the treatment options for and barriers to case management of neonatal pneumonia in India.

Methods and analysis

This protocol is part of a series of three reviews on neonatal pneumonia in India. Studies addressing treatment of or barriers to case management of neonatal pneumonia in Indian context, published in English in peer-reviewed and indexed journals will be eligible for inclusion. Electronic search will be conducted on nine databases. Hand searching and snowballing will be done for published and grey literature. Selection of studies will be done in title, abstract and full-text stages. A narrative summary will be performed to summarise the details of evidence.

Ethics and dissemination

As this is a review involving analysis of secondary data which is available in the public domain and does not involve human participants, ethical approval was not required. The findings of the study will be shared with all stakeholders of this research. Knowledge dissemination workshops will be conducted with relevant stakeholders to ultimately transfer the evidence tailored to the stakeholder (eg, policy briefs, publications, information booklets and so on).

PROSPERO 2016

CRD42016045449
Protocol for a scoping review of skin self-care of people with spinal cord injury
Authors: Lima Daniella Karine Souza , Schoeller Soraia Dornelles , Knihs Neide da Silva , Vargas Caroline Porcelis , Tholl Adriana Dutra , Lopes Soraia Geraldo Rozza , Martins Maria Manuela , Hammerschmidt Karina Silveira de Almeida
Published: September 2017

Introduction

In recent years, increasing methodological references have been used in scientific research; these are points of support in the search for evidence, formulation and elaboration of instruments, scales, guideline and protocols. However, significant variability currently exists in scoping review conduct and reporting, thus limiting the potential of the methodology to advance research and practice about skin self-care of people with spinal cord injury (SCI). Our objective was to perform a scoping review protocol within the health rehabilitation context of people with SCI, focusing on skin self-care.

Methods and analysis

The protocol was developed by using the scoping review methodological framework proposed by Arksey and O’Malley and further refined by the Joanna Briggs Institute, incorporating insights from more recent innovations in scoping review methodology. Sensitive searches of 13 electronic databases from 2007 to 2017 will be supplemented by grey literature searches. Two reviewers using a tool developed for this scoping review will screen eligible studies.

Ethics and dissemination

The scoping review will undertake a secondary analysis of previously collected data and does not require ethical approval; however, the ethical precepts of copyright will be respected. The results will facilitate a better understanding of the practical health rehabilitation context of people with SCI, the impacts of these rehabilitations and how to build an evidence base for this work in the future.
Prospective comparative effectiveness cohort study comparing two models of advance care planning provision for Australian community aged care clients
Authors: Detering Karen Margaret , Carter Rachel Zoe , Sellars Marcus William , Lewis Virginia , Sutton Elizabeth Anne
Published: September 2017

Objectives

Conduct a prospective comparative effectiveness cohort study comparing two models of advance care planning (ACP) provision in community aged care: ACP conducted by the client’s case manager (CM) (‘Facilitator’) and ACP conducted by an external ACP service (‘Referral’) over a 6-month period.

Methods

This Australian study involved CMs and their clients. Eligible CM were English speaking, ≥18 years, had expected availability for the trial and worked ≥3 days per week. CMs were recruited via their organisations, sequentially allocated to a group and received education based on the group allocation. They were expected to initiate ACP with all clients and to facilitate ACP or refer for ACP. Outcomes were quantity of new ACP conversations and quantity and quality of new advance care directives (ACDs).

Results

30 CMs (16 Facilitator, 14 Referral) completed the study; all 784 client’s files (427 Facilitator, 357 Referral) were audited. ACP was initiated with 508 (65%) clients (293 Facilitator, 215 Referral; p<0.05); 89 (18%) of these (53 Facilitator, 36 Referral) and 41 (46%) (13 Facilitator, 28 Referral; p<0.005) completed ACDs. Most ACDs (71%) were of poor quality/not valid. A further 167 clients (facilitator 124; referral 43; p<0.005) reported ACP was in progress at study completion.

Conclusions

While there were some differences, overall, models achieved similar outcomes. ACP was initiated with 65% of clients. However, fewer clients completed ACP, there was low numbers of ACDs and document quality was generally poor. The findings raise questions for future implementation and research into community ACP provision.
CNVs affecting cancer predisposing genes (CPGs) detected as incidental findings in routine germline diagnostic chromosomal microarray (CMA) testing
Authors: Innes Josie , Reali Lisa , Clayton-Smith Jill , Hall Georgina , Lim Derek HK , Burghel George J , French Kim , Khan Unzela , Walker Daniel , Lalloo Fiona , Evans D Gareth R , McMullan Dominic , Maher Eamonn R , Woodward Emma R
Published: September 2017

Background

Identification of CNVs through chromosomal microarray (CMA) testing is the first-line investigation in individuals with learning difficulties/congenital abnormalities. Although recognised that CMA testing may identify CNVs encompassing a cancer predisposition gene (CPG), limited information is available on the frequency and nature of such results.

Methods

We investigated CNV gains and losses affecting 39 CPGs in 3366 pilot index case individuals undergoing CMA testing, and then studied an extended cohort (n=10 454) for CNV losses at 105 CPGs and CNV gains at 9 proto-oncogenes implicated in inherited cancer susceptibility.

Results

In the pilot cohort, 31/3366 (0.92%) individuals had a CNV involving one or more of 16/39 CPGs. 30/31 CNVs involved a tumour suppressor gene (TSG), and 1/30 a proto-oncogene (gain of MET). BMPR1A, TSC2 and TMEM127 were affected in multiple cases. In the second stage analysis, 49/10 454 (0.47%) individuals in the extended cohort had 50 CNVs involving 24/105 CPGs. 43/50 CNVs involved a TSG and 7/50 a proto-oncogene (4 gains, 3 deletions). The most frequently involved genes, FLCN (n=10) and SDHA (n=7), map to the Smith-Magenis and cri-du-chat regions, respectively.

Conclusion

Incidental identification of a CNV involving a CPG is not rare and poses challenges for future cancer risk estimation. Prospective data collection from CPG-CNV cohorts ascertained incidentally and through syndromic presentations is required to determine the risks posed by specific CNVs. In particular, ascertainment and investigation of adults with CPG-CNVs and adults with learning disability and cancer, could provide important information to guide clinical management and surveillance.
Evaluation of previously embolized intracranial aneurysms: inter-and intra-rater reliability among neurosurgeons and interventional neuroradiologists
Authors: Zuckerman Scott L , Lakomkin Nikita , Magarik Jordan A , Vargas Jan , Stephens Marcus , Akinpelu Babatunde , Spiotta Alejandro M , Ahmed Azam , Arthur Adam S , Fiorella David , Hanel Ricardo , Hirsch Joshua A , Hui Ferdinand K , James Robert F , Kallmes David F , Meyers Philip M , Niemann David B , Rasmussen Peter , Turner Raymond D , Welch Babu G , Mocco J
Published: September 2017

Background

The angiographic evaluation of previously coiled aneurysms can be difficult yet remains critical for determining re-treatment.

Objective

The main objective of this study was to determine the inter-rater reliability for both the Raymond Scale and per cent embolization among a group of neurointerventionalists evaluating previously embolized aneurysms.

Methods

A panel of 15 neurointerventionalists examined 92 distinct cases of immediate post-coil embolization and 1 year post-embolization angiographs. Each case was presented four times throughout the study, along with alterations in demographics in order to evaluate intra-rater reliability. All respondents were asked to provide the per cent embolization (0–100%) and Raymond Scale grade (1-3) for each aneurysm. Inter-rater reliability was evaluated by computing weighted kappa values (for the Raymond Scale) and intraclass correlation coefficients (ICC) for per cent embolization.

Results

10 neurosurgeons and 5 interventional neuroradiologists evaluated 368 simulated cases. The agreement among all readers employing the Raymond Scale was fair (κ=0.35) while concordance in per cent embolization was good (ICC=0.64). Clinicians with fewer than 10 years of experience demonstrated a significantly greater level of agreement than the group with greater than 10 years (κ=0.39 and ICC=0.70 vs κ=0.28 and ICC=0.58). When the same aneurysm was presented multiple times, clinicians demonstrated excellent consistency when assessing per cent embolization (ICC=0.82), but moderate agreement when employing the Raymond classification (κ=0.58).

Conclusions

Identifying the per cent embolization in previously coiled aneurysms resulted in good inter- and intra-rater agreement, regardless of years of experience. The strong agreement among providers employing per cent embolization may make it a valuable tool for embolization assessment in this patient population.
Wall enhancement ratio and partial wall enhancement on MRI associated with the rupture of intracranial aneurysms
Authors: Wang Guang-xian , Wen Li , Lei Sheng , Ran Qian , Yin Jin-bo , Gong Zi-li , Zhang Dong
Published: September 2017

Objectives

To evaluate the risk factors for rupture of intracranial aneurysms (IAs) using high resolution MRI (HRMRI).

Methods

91 consecutive patients with 106 IAs were reviewed from February 2016 to April 2017. Patients and IAs were divided into ruptured and unruptured groups. In addition to the clinical characteristics of the patients, the features of IAs (eg, shape) were evaluated by CT angiography, whereas wall thickness, enhanced patterns, and enhancement ratio (ER) were evaluated by MRI. Multiple logistic regression analysis was used to identify independent risk factors associated with the rupture of IAs. Receiver operating characteristic curve analysis was performed on the final model, and the optimal thresholds were obtained.

Results

ER (OR 6.638) and partial wall enhancement (PWE) (OR 6.710) were not markers of aneurysms more prone to rupture, but simply were more commonly found in the ruptured aneurysm cohort. The threshold value for ER was 61.5%.

Conclusions

ER (≥61.5%) and IAs with PWE are better predictors of rupture. Increased attentions should be paid to these factors during assessment of IA rupture.
Return to work and lost earnings after acute respiratory distress syndrome: a 5-year prospective, longitudinal study of long-term survivors
Authors: Kamdar Biren B , Sepulveda Kristin A , Chong Alexandra , Lord Robert K , Dinglas Victor D , Mendez-Tellez Pedro A , Shanholtz Carl , Colantuoni Elizabeth , von Wachter Till M , Pronovost Peter J , Needham Dale M
Published: September 2017

Background

Delayed return to work is common after acute respiratory distress syndrome (ARDS), but has undergone little detailed evaluation. We examined factors associated with the timing of return to work after ARDS, along with lost earnings and shifts in healthcare coverage.

Methods

Five-year, multisite prospective, longitudinal cohort study of 138 2-year ARDS survivors hospitalised between 2004 and 2007. Employment and healthcare coverage were collected via structured interview. Predictors of time to return to work were evaluated using Fine and Grey regression analysis. Lost earnings were estimated using Bureau of Labor Statistics data.

Results

Sixty-seven (49%) of the 138 2-year survivors were employed prior to ARDS. Among 64 5-year survivors, 20 (31%)neverreturned to work across 5-year follow-up. Predictors of delayed return to work (HR (95% CI)) included baseline Charlson Comorbidity Index (0.77 (0.59 to 0.99) per point; p=0.04), mechanical ventilation duration (0.67 (0.55 to 0.82) per day up to 5 days; p<0.001) and discharge to a healthcare facility (0.49 (0.26 to 0.93); p=0.03). Forty-nine of 64 (77%) 5-year survivors incurred lost earnings, with average (SD) losses ranging from US$38 354 (21,533) to US$43 510 (25,753) per person per year. Jobless, non-retired survivors experienced a 33% decrease in private health insurance and concomitant 37% rise in government-funded coverage.

Conclusions

Across 5-year follow-up, nearly one-third of previously employed ARDS survivors never returned to work. Delayed return to work was associated with patient-related and intensive care unit/hospital-related factors, substantial lost earnings and a marked rise in government-funded healthcare coverage. These important consequences emphasise the need to design and evaluate vocation-based interventions to assist ARDS survivors return to work.
Healthcare resource use and costs of severe, uncontrolled eosinophilic asthma in the UK general population
Authors: Kerkhof Marjan , Tran Trung N , Soriano Joan B , Golam Sarowar , Gibson Danny , Hillyer Elizabeth V , Price David B
Published: September 2017

Background

Little is known about the prevalence of severe, uncontrolled eosinophilic asthma (SUEA) and associated costs.

Aims

We sought to determine the prevalence of SUEA and compare asthma-related healthcare resource use (HCRU) and associated costs with overall means for a general asthma population.

Methods

This cohort study evaluated anonymised medical record data (December 1989 through June 2015) from the Clinical Practice Research Datalink and the Optimum Patient Care Research Database to study UK patients with active asthma (diagnostic code and one or more drug prescriptions in the baseline year), aged 5 years and older, without concomitant COPD, and with recorded eosinophil count. SUEA was defined as two or more asthma attacks during 1 baseline year preceding a high blood eosinophil count (≥0.3×109/L) for patients prescribed long-acting β2-agonist (LABA) and high-dosage inhaled corticosteroids (ICS) during baseline plus 1 follow-up year. We compared asthma-related HCRU and associated direct costs (2015 pounds sterling, £) during the follow-up year for SUEA versus the general asthma population.

Results

Of 363 558 patients with active asthma and recorded eosinophil count, 64% were women, mean (SD) age was 49 (21) years; 43% had high eosinophil counts, 7% had two or more attacks in the baseline year and 10% were prescribed high-dosage ICS/LABA for 2 study years. Overall, 2940 (0.81%; 95% CI 0.78% to 0.84%) patients had SUEA. Total mean per-patient HCRU and associated costs were four times greater for SUEA versus all patients (HCRU and cost ratios 3.9; 95% CI 3.7 to 4.1).

Conclusions

Less than 1% of patients in a general asthma population had SUEA. These patients accounted for substantially greater asthma-related HCRU and costs than average patients with asthma.
Prevalence of and risk factors for FIV and FeLV infection in two shelters in the United Kingdom (2011–2012)
Authors: Stavisky Jenny , Dean Rachel Sarah , Molloy Michael Henry
Published: September 2017

The aims of this study were to determine the prevalence of feline leukaemia virus (FeLV) and feline immunodeficiency virus (FIV) infections in cats presented to two RSPCA (Royal Society for the Prevention of Cruelty to Animals) animal rehoming centres and to identify risk factors for infection. All cats presented at each centre between August 2011 and August 2012 were subjected to a patient‐side test for FeLV/FIV on entry. Kittens under three months and cats euthanased within a short time of presentation were excluded from the study. Univariable and multivariable logistic regression were used to separately determine risk factors for FeLV and FIV infections. At shelter A, the prevalence of FIV infection was 11.4 per cent (54/474) and FeLV infection was 3 per cent (14/473), with two FIV/FeLV coinfections identified. At shelter B, the prevalence of FIV infection was 3 per cent (4/135) and FeLV infection was 0 per cent (0/135). Cats at shelter A were significantly more likely than those at shelter B to test positive for FIV (p=0.0024) and FeLV (p=0.048). Male cats were more likely to be infected with FIV (odds ratio 27.1, p=0.001), and thin body condition and musculoskeletal disease were associated with risk of FeLV. Overall, FIV‐positive and FeLV‐positive cats were significantly older (median ages 5.1 and 4.75 years, respectively) than the uninfected populations (median ages 3.4 and 3.5 years, respectively). This study shows that the prevalence of these diseases varies between shelter populations. Local knowledge combined with the risk factors identified may be useful in focusing resources for population testing strategies.
Age-related decline in endurance running performance – an example of a multiple World records holder
Authors: Lepers Romuald , Cattagni Thomas
Published: September 2017

This study examined the age-related decline in endurance running performance of one of the greatest master runners ever, Ed Whitlock, who died recently. His running performances from 1500 m to marathon were analyzed for 5 periods of 5 years from 65–69 years to 85–89 years. Despite exceptional running performances for his advanced age, the rate of decline in his performances increased after 80 years and was drastically amplified after 85 years.