bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prognostic variables and scores identifying the last year of life in COPD: a systematic review protocol
Authors: Smith Laura-Jane E , Ali Ifrah , Stone Patrick , Smeeth Liam , Quint Jennifer K 
Published: September 2016

IntroductionPeople living with advanced chronic obstructive pulmonary disease (COPD) suffer from significant morbidity, reduced quality of life and high mortality, and are likely to benefit from many aspects of a palliative care approach. Prognostic estimates are a meaningful part of decision-making and better evidence for such estimates would facilitate advance care planning. We aim to provide quality evidence on known prognostic variables and scores which predict a prognosis in COPD of <12 months for use in the community.Methods and analysisWe will conduct a systematic review of randomised or quasi-randomised controlled trials, prospective and retrospective longitudinal cohort and case–control studies on prognostic variables, multivariate scores or models for COPD. The search will cover the period up to April 2016. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, with data extraction using fields from the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS) checklist for multivariate models, and study quality will be assessed using a modified version of the Quality In Prognosis Studies (QUIPS) tool.Ethics and disseminationThe results will be disseminated through peer-reviewed publications and national and international conference presentations.Systematic review registration numberCRD42016033866.
Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India
Authors: Liu Hueiming , Lindley Richard , Alim Mohammed , Felix Cynthia , Gandhi Dorcas B C , Verma Shweta J , Tugnawat Deepak Kumar , Syrigapu Anuradha , Ramamurthy Ramaprabhu Krishnappa , Pandian Jeyaraj D , Walker Marion , Forster Anne , Anderson Craig S , Langhorne Peter , Murthy Gudlavalleti Venkata Satyanarayana , Shamanna Bindiganavale Ramaswamy , Hackett Maree L , Maulik Pallab K , Harvey Lisa A , Jan Stephen 
Published: September 2016

IntroductionWe are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India. A process evaluation is needed to understand how and why this complex intervention may be effective, and to capture important barriers and facilitators to its implementation. We describe the protocol for our process evaluation to encourage the development of in-process evaluation methodology and transparency in reporting.Methods and analysisThe realist and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) frameworks informed the design. Mixed methods include semistructured interviews with health providers, patients and their carers, analysis of quantitative process data describing fidelity and dose of intervention, observations of trial set up and implementation, and the analysis of the cost data from the patients and their families perspective and programme budgets. These qualitative and quantitative data will be analysed iteratively prior to knowing the quantitative outcomes of the trial, and then triangulated with the results from the primary outcome evaluation.Ethics and disseminationThe process evaluation has received ethical approval for all sites in India. In low-income and middle-income countries, the available human capital can form an approach to reducing the evidence practice gap, compared with the high cost alternatives available in established market economies. This process evaluation will provide insights into how such a programme can be implemented in practice and brought to scale. Through local stakeholder engagement and dissemination of findings globally we hope to build on patient-centred, cost-effective and sustainable models of stroke rehabilitation.Trial registration numberCTRI/2013/04/003557.
Establishing cross-discipline consensus on contraception, pregnancy and breast feeding-related educational messages and clinical practices to support women with rheumatoid arthritis: an Australian Delphi study
Authors: Briggs Andrew M , Jordan Joanne E , Ackerman Ilana N , Van Doornum Sharon 
Published: September 2016

ObjectiveRecognising the need for a best-practice and consistent approach in providing care to women with rheumatoid arthritis (RA) in relation to (1) general health, (2) contraception, (3) conception and pregnancy, (4) breast feeding and (5) early parenting, we sought to achieve cross-discipline, clinical consensus on key messages and clinical practice behaviours in these 5 areas.Design3-round eDelphi study. In round 1, panellists provided free-text responses to open-ended questions about care for women with RA across the 5 areas. Subsequently, panellists refined and scored the synthesised responses, presented as metathemes, themes and detailed elements. Where ≥5% of panellists did not support a theme in a given round, it was removed.SettingPanel of practicing Australian rheumatologists (n=22), obstetricians/obstetric medicine physicians (n=9) and pharmacists (n=5).Results34 (94.4%) panellists participated in all 3 rounds. The panel supported 18 themes across the 5 areas (support/strongly support: 88.2–100%) underpinned by 5 metathemes. Metathemes focused on coordination in information delivery, the mode and timing of information delivery, evidence underpinning information, engagement of the right health professionals at the right time and a non-judgemental approach to infant feeding. Themes included practices for primary prevention of chronic disease and their sequelae, the importance of contraception and planning pregnancy and breast feeding, close monitoring of medications, supporting mental well-being, managing disease activity and providing practical support for early parenting.ConclusionsA cross-disciplinary clinical panel highly supported key information and clinical practices in the care for women with RA across the continuum of contraception to early parenting within a whole-person, chronic disease management approach.
Epidemiology of lower respiratory infection and pneumonia in South Africa (1997–2015): a systematic review protocol
Authors: Roomaney Rifqah A , Pillay-van Wyk Victoria , Awotiwon Oluwatoyin F , Dhansay Ali , Groenewald Pam , Joubert Jané D , Nglazi Mweete D , Nicol Edward , Bradshaw Debbie 
Published: September 2016

IntroductionLower respiratory infections (LRIs) and pneumonia are among the leading causes of death worldwide, especially in children aged under 5 years, and these patterns are reflected in the South African population. Local epidemiological data for LRIs and pneumonia are required to inform the Second National Burden of Disease Study underway in South Africa. The aim of this systematic review is to identify published studies reporting the prevalence, incidence, case fatality, duration or severity of LRI and pneumonia in adults and children in South Africa.Methods and analysisElectronic database searches will be conducted to obtain studies reporting on the prevalence, incidence, case fatality, duration and severity of LRI and pneumonia in South Africa between January 1997 and December 2015. Studies that are assessed to have moderate or low risk of bias will be included in a meta-analysis, if appropriate. Where meta-analysis is not possible, the articles will be described narratively. Subgroup analysis (eg, age groups) will also be conducted where enough information is available.Ethics and disseminationThis systematic review will only include published data with no linked patient-level information; thus, no ethics approval is required. The findings will be used to calculate the burden of disease attributed to LRI and pneumonia in South Africa and will highlight the type of epidemiological data available in the country. The article will be disseminated in a peer-reviewed publication.PROSPERO registration numberCRD42016036520.
Exploring effects of presurgical weight loss among women with stage 0–II breast cancer: protocol for a randomised controlled feasibility trial
Authors: Tsuruta Yuko , Rogers Laura Q , Krontiras Helen , Grizzle William E , Frugé Andrew D , Oster Robert A , Umphrey Heidi R , Jones Lee W , Azrad Maria , Demark-Wahnefried Wendy 
Published: September 2016

IntroductionObesity is a known risk factor for postmenopausal breast cancer and is associated with poorer prognosis for premenopausal and postmenopausal patients; however, the aetiological mechanisms are unknown. Preclinical studies support weight loss via caloric restriction and increased physical activity as a possible cancer control strategy, though few clinical studies have been conducted. We undertook a feasibility trial among women recently diagnosed with stage 0–II breast cancer hypothesising that presurgical weight loss would be feasible, safe and result in favourable changes in tumour markers and circulating biomarkers.Methods and analysisA two-arm randomised controlled trial among 40 overweight or obese women, newly diagnosed with stage 0–II breast cancer and scheduled for surgery was planned. The attention control arm received upper body progressive resistance training and diet counselling to correct deficiencies in nutrient intake; the experimental arm received the same plus counselling on caloric restriction and aerobic exercise to achieve a weight loss of 0.68–0.919 kg/week. In addition to achieving feasibility benchmarks (accruing and retaining at least 80% of participants, and observing no serious adverse effects attributable to the intervention), we will explore the potential impact of an acute state of negative energy balance on tumour proliferation rates (Ki-67), as well as other tumour markers, serum biomarkers, gene expression, microbiome profiles and other clinical outcomes (eg, quality of life). Outcomes for the 2 study arms are compared using mixed models repeated-measures analyses.Ethics and disseminationEthics approval was received from the University of Alabama at Birmingham Institutional Review Board (Protocol number F130325009). Study findings will be disseminated through peer-reviewed publications. Given that this is one of the first studies to investigate the impact of negative energy balance directly on tumour biology in humans, larger trials will be pursued if results are favourable.Trial registration numberNCT02224807; Pre-results.
Subarachnoid haemorrhage guidelines and clinical practice: a cross-sectional study of emergency department consultants' and neurospecialists' views and risk tolerances
Authors: Lansley J , Selai C , Krishnan A S , Lobotesis K , Jäger H R 
Published: September 2016

ObjectivesTo establish if emergency medicine and neuroscience specialist consultants have different risk tolerances for investigation of suspected spontaneous subarachnoid haemorrhage (SAH), and to establish if their risk–benefit appraisals concur with current guidelines.Setting4 major neuroscience centres in London.Participants58 consultants in emergency medicine and neuroscience specialities (neurology, neurosurgery and neuroradiology) participated in an anonymous survey.Primary and secondary outcome measuresThe primary outcome measure was the highest stated acceptable risk of missing SAH in the neurologically intact patient presenting with sudden onset headache. Secondary outcome measures included agreement with guideline recommendations, risk/benefit appraisal and required performance of diagnostic tests, including lumbar puncture.ResultsEmergency department clinicians accepted almost 3 times the risk of a missed SAH diagnosis compared with the neuroscience specialists (2.8% vs 1.1%; p=0.02), were more likely to accept a higher risk of missed diagnosis for the benefit of a non-invasive test (p=0.04) and were more likely to disagree with current published guidelines stipulating the need for LP in all CT-negative cases (p=0.001).ConclusionsDivergence from recognised procedures for SAH investigation is often criticised and attributed to a lack of knowledge of guidelines. This study indicates that divergence from guidelines may be explained by alternative risk–benefit appraisals made by doctors with their patients. Guideline recommendations may gain wider acceptance if they accommodate the requirements of the doctors and patients using them. Further study of clinical risk tolerance may help explain patterns of diagnostic test use and other variations in healthcare delivery.
Determinants and trends in health facility-based deliveries and caesarean sections among married adolescent girls in Bangladesh
Authors: Shahabuddin A S M , Delvaux Thérèse , Utz Bettina , Bardají Azucena , De Brouwere Vincent 
Published: September 2016

ObjectiveTo identify the determinants and measure the trends in health facility-based deliveries and caesarean sections among married adolescent girls in Bangladesh.MethodsIn order to measure the trends in health facility-based deliveries and caesarean sections, Bangladesh Demographic Health Survey (BDHS) data sets were analysed (BDHS; 1993–1994, 1996–1997, 1999–2000, 2004, 2007, 2011). The BDHS 2011 data sets were analysed to identify the determinants of health facility-based deliveries and caesarean sections. A total of 2813 adolescent girls (aged 10–19 years) were included for analysis. Bivariate and multivariate analyses were performed.ResultsHealth facility-based deliveries have continuously increased among adolescents in Bangladesh over the past two decades from 3% in 1993–1994 to 24.5% in 2011. Rates of population-based and facility-based caesarean sections have increased linearly among all age groups of women including adolescents. Although the country's overall (population-based) caesarean section rate among adolescents was within acceptable range (11.6%), a rate of nearly 50% health facility level caesarean sections among adolescent girls is alarming. Among adolescent girls, use of antenatal care (ANC) appeared to be the most important predictor of health facility-based delivery (OR: 4.04; 95% CI 2.73 to 5.99), whereas the wealth index appeared as the most important predictor of caesarean sections (OR: 5.7; 95% CI 2.74 to 12.1).ConclusionsMaternal health-related interventions should be more targeted towards adolescent girls in order to encourage them to access ANC and promote health facility-based delivery. Rising trends of caesarean sections require further investigation on indication and provider–client-related determinants of these interventions among adolescent girls in Bangladesh.
Do GPs know their patients with cancer? Assessing the quality of cancer registration in Dutch primary care: a cross-sectional validation study
Authors: Sollie Annet , Roskam Jessika , Sijmons Rolf H , Numans Mattijs E , Helsper Charles W 
Published: September 2016

ObjectivesTo assess the quality of cancer registry in primary care.Design and settingA cross-sectional validation study using linked data from primary care electronic health records (EHRs) and the Netherlands Cancer Registry (NCR).Population290 000 patients, registered with 120 general practitioners (GPs), from 50 practice centres in the Utrecht area, the Netherlands, in January 2013.InterventionLinking the EHRs of all patients in the Julius General Practitioners’ Network database at an individual patient level to the full NCR (∼1.7 million tumours between 1989 and 2011), to determine the proportion of matching cancer diagnoses. Full-text EHR extraction and manual analysis for non-matching diagnoses.Main outcome measuresProportions of matching and non-matching breast, lung, colorectal and prostate cancer diagnoses between 2007 and 2011, stratified by age category, cancer type and EHR system. Differences in year of diagnosis between the EHR and the NCR. Reasons for non-matching diagnoses.ResultsIn the Primary Care EHR, 60.6% of cancer cases were registered and coded in accordance with the NCR. Of the EHR diagnoses, 48.9% were potentially false positive (not registered in the NCR). Results differed between EHR systems but not between age categories or cancer types. The year of diagnosis corresponded in 80.6% of matching coded diagnoses. Adding full-text EHR analysis improved results substantially. A national disease registry (the NCR) proved incomplete.ConclusionsEven though GPs do know their patients with cancer, only 60.6% are coded in concordance with the NCR. Reusers of coded EHR data should be aware that 40% of cases can be missed, and almost half can be false positive. The type of EHR system influences registration quality. If full-text manual EHR analysis is used, only 10% of cases will be missed and 20% of cases found will be wrong. EHR data should only be reused with care.
Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial
Authors: Kallesøe Karen Hansen , Schröder Andreas , Wicksell Rikard K , Fink Per , Ørnbøl Eva , Rask Charlotte Ulrikka 
Published: September 2016

IntroductionFunctional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS).Methods and analysisA total of 120 adolescents aged 15–19 and diagnosed with multiorgan BDS, of at least 12 months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27 hours) and 1 follow-up meeting (3 hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12 months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility.Ethics and disseminationThe study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals.DiscussionThis is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a range of severe FSS.Trial registration numberNCT02346071; Pre-results.
Bioethics training programmes for Africa: evaluating professional and bioethics-related achievements of African trainees after a decade of Fogarty NIH investment
Authors: Kass Nancy E , Ali Joseph , Hallez Kristina , Hyder Adnan A 
Published: September 2016

ObjectivesOur primary aim was to evaluate the impact of US National Institutes of Health (NIH)-funded bioethics training programmes (Fogarty bioethics training programmes, FBTPs) that trained individuals from Africa over the programme's first 10 years to examine changes between pretraining and post-training in individual achievement and to document any associations between individual, training programme and post-training accomplishments.DesignWe surveyed trainees from the 10 bioethics programmes funded by NIH Fogarty International Center from 2000 to 2011 that included African trainees. McNemar's and Wilcoxon signed rank-sum tests were used to analyse pre–post levels of general and bioethics-related professional achievement. Likelihood of specific post-training achievement outcomes was measured using logistic regression including demographic, pretraining and intratraining variables.Setting10 different FBTPs that trained individuals from Africa from 2000 to 2011.ParticipantsOf 253 eligible respondents, 171 completed the survey (response rate 67.6%).Primary outcome measuresPre–post comparisons of professional achievement indicators (eg, serving in leadership roles, teaching, publishing manuscripts); likelihood of specific post-training achievement outcomes.ResultsPost-training, respondents were significantly more likely to report serving in a leadership role, being an investigator on a research grant, serving on international committees, serving as a mentor, and publishing manuscripts than at pretraining. Post-training, significantly greater numbers of respondents reported bioethics-related achievements including being a bioethics instructor, serving on an Institutional Review Board (IRB), being an investigator on a bioethics grant and publishing bioethics-related manuscripts than pretraining. Controlling for other factors, there were no significant differences by gender in the post-training success of these participants in terms of leadership roles, being instructors, investigators on grants and holding IRB roles.ConclusionsAfrican trainees who participated in FBTPs reported significantly higher levels of professional achievement after training. There was no single factor—either demographic, related to a trainee's professional background, or in programme design—that consistently predicted greater levels of post-training achievement.
Rates and drivers of progression to pre-diabetes and diabetes mellitus among HIV-infected adults on antiretroviral therapy: a global systematic review and meta-analysis protocol
Authors: Nansseu Jobert Richie N , Bigna Jean Joel R , Kaze Arnaud D , Noubiap Jean Jacques N 
Published: September 2016

IntroductionWith the new ‘test and treat’ policy of the WHO, it is obvious that the number of HIV-infected patients taking antiretroviral therapy (ART) will grow exponentially, with consequential increase in the burden of diabetes mellitus (DM). Our aim is to summarise existing data on the incidence of pre-diabetes and DM, and associated risk factors among HIV-infected adults.Methods and analysisThis systematic review will include cohort studies reporting the incidence of pre-diabetes and/or DM, and associated risk factors among HIV-infected adults on ART, with these patients being free of any impaired glucose metabolism at study baseline. We will perform electronic searches in PubMed, Excerpta Medica Database (EMBASE), Web of Science and WHO Global Health Library, supplemented with manual searches. Articles published from 1 January 2000 to 31 July 2016, in English or French languages, and without any geographical restriction will be eligible for inclusion. 3 authors will independently screen, select studies, extract data and assess the risk of bias with discrepancies resolved by consensus. We will assess clinical heterogeneity by examining the study design and setting, criteria and cut-offs used to define pre-diabetes or DM, process of calculation of incidence and outcomes in each study. We will also assess statistical heterogeneity using the χ2test of homogeneity and quantify it using the I2statistic. A random effects meta-analysis will be used to estimate the overall cumulative incidence of pre-diabetes/DM and risk factors.Ethics and disseminationThis systematic review will use data from published studies and does not require ethics approval. Its results are expected to help putting in place action plans and preventive measures to curb the growing burden of DM in the HIV population on ART. Findings will be published in a peer-reviewed journal and presented at scientific conferences.PROSPERO registration numberCRD42016039651.