bluuebunny/crossref_metadata_2025_split huggingface dataset:
Using mixed methods to assess fidelity of delivery and its influencing factors in a complex self-management intervention for people with osteoarthritis and low back pain
Authors: Toomey Elaine , Matthews James , Hurley Deirdre A 
Published: December 2018

Objectives and designDespite an increasing awareness of the importance of fidelity of delivery within complex behaviour change interventions, it is often poorly assessed. This mixed methods study aimed to establish the fidelity of delivery of a complex self-management intervention and explore the reasons for these findings using a convergent/triangulation design.SettingFeasibility trial of the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention (ISRCTN49875385), delivered in primary care physiotherapy.Methods and outcomes60 SOLAS sessions were delivered across seven sites by nine physiotherapists. Fidelity of delivery of prespecified intervention components was evaluated using (1) audio-recordings (n=60), direct observations (n=24) and self-report checklists (n=60) and (2) individual interviews with physiotherapists (n=9). Quantitatively, fidelity scores were calculated using percentage means and SD of components delivered. Associations between fidelity scores and physiotherapist variables were analysed using Spearman's correlations. Interviews were analysed using thematic analysis to explore potential reasons for fidelity scores. Integration of quantitative and qualitative data occurred at an interpretation level using triangulation.ResultsQuantitatively, fidelity scores were high for all assessment methods; with self-report (92.7%) consistently higher than direct observations (82.7%) or audio-recordings (81.7%). There was significant variation between physiotherapists’ individual scores (69.8% - 100%). Both qualitative and quantitative data (from physiotherapist variables) found that physiotherapists’ knowledge (Spearman's association at p=0.003) and previous experience (p=0.008) were factors that influenced their fidelity. The qualitative data also postulated participant-level (eg, individual needs) and programme-level factors (eg, resources) as additional elements that influenced fidelity.ConclusionThe intervention was delivered with high fidelity. This study contributes to the limited evidence regarding fidelity assessment methods within complex behaviour change interventions. The findings suggest a combination of quantitative methods is suitable for the assessment of fidelity of delivery. A mixed methods approach provided a more insightful understanding of fidelity and its influencing factors.Trial registration numberISRCTN49875385; Pre-results.
Protocol for validation of the 4AT, a rapid screening tool for delirium: a multicentre prospective diagnostic test accuracy study
Authors: Shenkin Susan D , Fox Christopher , Godfrey Mary , Siddiqi Najma , Goodacre Steve , Young John , Anand Atul , Gray Alasdair , Smith Joel , Ryan Tracy , Hanley Janet , MacRaild Allan , Steven Jill , Black Polly L , Boyd Julia , Weir Christopher J , MacLullich Alasdair MJ 
Published: December 2018

IntroductionDelirium is a severe neuropsychiatric syndrome of rapid onset, commonly precipitated by acute illness. It is common in older people in the emergency department (ED) and acute hospital, but greatly under-recognised in these and other settings. Delirium and other forms of cognitive impairment, particularly dementia, commonly coexist. There is a need for a rapid delirium screening tool that can be administered by a range of professional-level healthcare staff to patients with sensory or functional impairments in a busy clinical environment, which also incorporates general cognitive assessment. We developed the 4 ’A’s Test (4AT) for this purpose. This study’s primary objective is to validate the 4AT against a reference standard. Secondary objectives include (1) comparing the 4AT with another widely used test (the Confusion Assessment Method (CAM)); (2) determining if the 4AT is sensitive to general cognitive impairment; (3) assessing if 4AT scores predict outcomes, including (4) a health economic analysis.Methods and analysis900 patients aged 70 or over in EDs or acute general medical wards will be recruited in three sites (Edinburgh, Bradford and Sheffield) over 18 months. Each patient will undergo a reference standard delirium assessment and will be randomised to assessment with either the 4AT or the CAM. At 12 weeks, outcomes (length of stay, institutionalisation and mortality) and resource utilisation will be collected by a questionnaire and via the electronic patient record.Ethics and disseminationEthical approval was granted in Scotland and England. The study involves administering tests commonly used in clinical practice. The main ethical issues are the essential recruitment of people without capacity. Dissemination is planned via publication in high impact journals, presentation at conferences, social media and the websitewww.the4AT.com.Trial registration numberISRCTN53388093; Pre-results.
Paediatric asthma control under a community management model in China: a protocol for a prospective multicentre cohort study
Authors: Xu Juan , Yin Yong , Zhang Hao , Zhong Wen Wei , Zhang Lei , Zhang Jing , Yuan Shu Hua , Zhang Fen , Zhao Li Xia 
Published: December 2018

IntroductionChildhood asthma is globally one of the most common respiratory disorders and accounts for more school absences and more hospitalizations than any other chronic illness. The worldwide economic burden of this disease exceeds those of HIV/AIDS and tuberculosis combined. Proper intervention and effective management is of paramount importance for the control and prognosis of paediatric asthma. Unfortunately, the rate of uncontrolled and partially controlled paediatric asthma in China is >90%. This study will use a new management model to investigate the status of asthma control and the adherence of patients to a medication protocol.MethodsThis prospective, multicentre, observational study will be conducted at 15 hospitals on children (n=800) diagnosed with asthma. Each patient will be assigned to either the nearest community hospital or Shanghai Children's Medical Center, whichever is closer to the patient's home, according to the decision of parents. Participants were divided into two groups: tertiary care hospital (Shanghai Children's Medical Center) follow-up group and community hospital follow-up group. The primary outcome will be the difference in the proportion of controlled, partially controlled and uncontrolled asthma among the two groups. Secondary outcomes will be the differences in adherence rate, lung function, exacerbations, growth development, total asthma-related unscheduled visits, days absent from school and loss of working days for the patient's caregiver. Data will be analysed on an intention-to-treat and a per-protocol basis.Ethics and disseminationEthics approval was obtained from the Institutional Review Board of Shanghai Children's Medical Center affiliated with Shanghai Jiao Tong University of Medicine. We plan to publish the results of this study in a peer-reviewed journal article.
Challenges and facilitators for health professionals providing primary healthcare for refugees and asylum seekers in high-income countries: a systematic review and thematic synthesis of qualitative research
Authors: Robertshaw Luke , Dhesi Surindar , Jones Laura L 
Published: December 2018

ObjectivesTo thematically synthesise primary qualitative studies that explore challenges and facilitators for health professionals providing primary healthcare for refugees and asylum seekers in high-income countries.DesignSystematic review and qualitative thematic synthesis.MethodsSearches of MEDLINE, EMBASE, PsycINFO, CINAHL and Web of Science. Search terms were combined for qualitative research, primary healthcare professionals, refugees and asylum seekers, and were supplemented by searches of reference lists and citations. Study selection was conducted by two researchers using prespecified selection criteria. Data extraction and quality assessment using the Critical Appraisal Skills Programme tool was conducted by the first author. A thematic synthesis was undertaken to develop descriptive themes and analytical constructs.ResultsTwenty-six articles reporting on 21 studies and involving 357 participants were included. Eleven descriptive themes were interpreted, embedded within three analytical constructs: healthcare encounter (trusting relationship, communication, cultural understanding, health and social conditions, time); healthcare system (training and guidance, professional support, connecting with other services, organisation, resources and capacity); asylum and resettlement. Challenges and facilitators were described within these themes.ConclusionsA range of challenges and facilitators have been identified for health professionals providing primary healthcare for refugees and asylum seekers that are experienced in the dimensions of the healthcare encounter, the healthcare system and wider asylum and resettlement situation. Comprehensive understanding of these challenges and facilitators is important to shape policy, improve the quality of services and provide more equitable health services for this vulnerable group.
A national surveillance project on chronic kidney disease management in Canadian primary care: a study protocol
Authors: Bello Aminu K , Ronksley Paul E , Tangri Navdeep , Singer Alexander , Grill Allan , Nitsch Dorothea , Queenan John A , Lindeman Cliff , Soos Boglarka , Freiheit Elizabeth , Tuot Delphine , Mangin Dee , Drummond Neil 
Published: December 2018

IntroductionEffective chronic disease care is dependent on well-organised quality improvement (QI) strategies that monitor processes of care and outcomes for optimal care delivery. Although healthcare is provincially/territorially structured in Canada, there are national networks such as the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) as important facilitators for national QI-based studies to improve chronic disease care. The goal of our study is to improve the understanding of how patients with chronic kidney disease (CKD) are managed in primary care and the variation across practices and provinces and territories to drive improvements in care delivery.Methods and analysisThe CPCSSN database contains anonymised health information from the electronic medical records for patients of participating primary care practices (PCPs) across Canada (n=1200). The dataset includes information on patient sociodemographics, medications, laboratory results and comorbidities. Leveraging validated algorithms, case definitions and guidelines will help define CKD and the related processes of care, and these enable us to: (1) determine prevalent CKD burden; (2) ascertain the current practice pattern on risk identification and management of CKD and (3) study variation in care indicators (eg, achievement of blood pressure and proteinuria targets) and referral pattern for specialist kidney care. The process of care outcomes will be stratified across patients’ demographics as well as provider and regional (provincial/territorial) characteristics. The prevalence of CKD stages 3–5 will be presented as age–sex standardised prevalence estimates stratified by province and as weighted averages for population rates with 95% CIs using census data. For each PCP, age–sex standardised prevalence will be calculated and compared with expected standardised prevalence estimates. The process-based outcomes will be defined using established methods.Ethics and disseminationThe CPCSSN is committed to high ethical standards when dealing with individual data collected, and this work is reviewed and approved by the Network Scientific Committee. The results will be published in peer-reviewed journals and presented at relevant national and international scientific meetings.
Observational study of vascular dementia in the Spanish elderly population according to type 2 diabetes status: trends in incidence, characteristics and outcomes (2004-2013)
Authors: Muñoz-Rivas Nuria , Méndez-Bailón Manuel , Miguel-Yanes José M de , Hernández-Barrera Valentín , Miguel-Díez Javier de , Jimenez-Garcia Rodrigo , López-de-Andrés Ana 
Published: December 2018

ObjectivesTo examine trends overtime in the incidence and in-hospital outcomes of vascular dementia (VaD) hospitalisations in patients aged 70 years or over suffering and not suffering from type 2 diabetes mellitus (T2DM) between 2004 and 2013 in Spain.DesignRetrospective study.SettingSpain.ParticipantsNational hospital discharge data were used; patients aged ≥70, discharged from a hospital with VaD as a primary diagnosis, were selected.Main outcome measuresOverall incidence, therapeutic and diagnostic procedures, comorbidities, infectious complications, duration of hospital stays and in-hospital mortality (IHM).ResultsIn total, 170 607 admissions for VaD (34.3% with T2DM) were identified. We found a significant upward linear trend in the incidence of VaD for men and women with and without diabetes between 2004 and 2013. The adjusted incidence was higher among people with T2DM over the study period. We found a higher incidence in men than women in all years under study. A positive association between T2DM and VaD hospitalisation was found among both men (IRR 2.14, 95% CI 2.11 to 2.16) and women (incidence rate ratio (IRR) 2.22; 95% CI 2.19 to 2.25). Pneumonia was significantly associated with a higher mortality (OR 2.59, 95% CI 2.52 to 2.67). We found that percutaneous endoscopic gastrostomy was associated with lower IHM (OR 0.37, 95% CI 0.31 to 0.45), while parenteral nutrition had the opposite effect (OR 1.29, 95% CI 1.18 to 1.41). There was no association between diabetes and higher IHM (OR 0.99, 95% CI 0.93 to 1.06). The time-trend analyses of the entire sample showed a significant reduction in mortality in patients with VaD (OR 0.98, 95% CI 0.97 to 0.99).ConclusionsIncidence rates for VaD hospitalisations were twice as high in patients with diabetes compared with those without. Men had significantly higher incidence rates than women, regardless of diabetes status. In both groups studied, pneumonia and parenteral nutrition were associated with mortality while percutaneous endoscopic gastrostomy was associated with survival. Having diabetes was not associated with higher IHM after hospitalisation with VaD.
Rethinking exercise identity: a qualitative study of physically inactive cancer patients’ transforming process while undergoing chemotherapy
Authors: Adamsen Lis , Andersen Christina , Lillelund Christian , Bloomquist Kira , Møller Tom 
Published: December 2018

ObjectiveTo explore physically inactive breast and colon cancer patients’ prediagnosis exercise history and attitudes to physical activity (PA) and experiences in initiating PA while undergoing adjuvant chemotherapy.DesignAn explorative qualitative study guided the interpretive analysis of semistructured, open-ended interviews conducted at initiation of chemotherapy and after 12 weeks. The study was embedded in a pilot randomised controlled trial.SettingParticipants were recruited from the Oncological Department at a hospital in Copenhagen, Denmark.Participants33 patients with cancer, median age 49 years: 25 patients with breast cancer and 8 with colon cancer, 72% with a low cardiac respiratory fitness level and the majority with a high level of education. Patients received adjuvant chemotherapy, oncologist’s PA recommendation and exercise, cancer nurse specialist’s counselling prior to allocation to PA interventions or waitlist control group.ResultsPrediagnosis exercise had been excluded from patients’ daily lives due to perceptions of exercise as boring, lack of discipline and stressful work conditions for both genders. Recommendations from oncologists and nurses inspired the patients to reconsider their attitudes and behaviour by accepting recruitment and participation in PA interventions during chemotherapy. Despite extensive side effects, most patients adhered to their PA commitment due to their perception of the bodily, emotional and social benefits and support of healthcare professionals, peers and family.ConclusionThe patients’ attitude towards exercise transformed from having no priority in patients’ daily lives prediagnosis to being highly prioritised. This study identified four important phases in the exercise transformation process during the patients’ treatment trajectory of relevance to clinicians in identifying, motivating and supporting physically inactive patients with cancer at long-term risk. Clinicians should address young, highly educated patients with cancer at onset of adjuvant chemotherapy due to their specific risk of a sedentary lifestyle resulting from being in stressful, ambitious careers.Trial registration numberCurrent Controlled Trials (ISRCTN24901641), Stage: Qualitative results.
Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) in primary care using total diet replacement products: a protocol for a randomised controlled trial
Authors: Jebb Susan A , Astbury Nerys M , Tearne Sarah , Nickless Alecia , Aveyard Paul 
Published: December 2018

IntroductionThe global prevalence of obesity has risen significantly in recent decades. There is a pressing need to identify effective interventions to treat established obesity that can be delivered at scale. The aim of the Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) study is to determine the clinical effectiveness, feasibility and acceptability of referral to a low-energy total diet replacement programme compared with usual weight management interventions in primary care.Methods and analysisThe DROPLET trial is a randomised controlled trial comparing a low-energy total diet replacement programme with usual weight management interventions delivered in primary care. Eligible patients will be recruited through primary care registers and randomised to receive a behavioural support programme delivered by their practice nurse or a referral to a commercial provider offering an initial 810 kcal/d low-energy total diet replacement programme for 8 weeks, followed by gradual food reintroduction, along with weekly behavioural support for 24 weeks. The primary outcome is weight change at 12 months. The secondary outcomes are weight change at 3 and 6 months, the proportion of participants achieving 5% and 10% weight loss at 12 months, and change in fat mass, haemoglobin A1c, low-density lipoprotein cholesterol and systolic and diastolic blood pressure at 12 months. Data will be analysed on the basis of intention to treat. Qualitative interviews on a subsample of patients and healthcare providers will assess their experiences of the weight loss programmes and identify factors affecting acceptability and adherence.Ethics and disseminationThis study has been reviewed and approved by the National Health ServiceHealth Research Authority (HRA)Research Ethics Committee (Ref: SC/15/0337). The trial findings will be disseminated to academic and health professionals through presentations at meetings and peer-reviewed journals and to the public through the media. If the intervention is effective, the results will be communicated to policymakers and commissioners of weight management services.Trial registration numberISRCTN75092026.
Behaviour change interventions for the management of Raynaud's phenomenon: a systematic review protocol
Authors: Daniels Jo , Pauling John D , Eccelston Christopher 
Published: December 2018

IntroductionRaynaud's phenomenon (RP) describes excessive peripheral vasospasm to cold exposure and/or emotional stress. RP episodes are associated with digital colour changes, pain and reduced quality of life. Pharmacological interventions are of low to moderate efficacy and often result in adverse effects such as facial flushing and headaches. Recommended lifestyle and behavioural interventions have not been evaluated. The objectives of the proposed systematic review are to assess the comparative safety and efficacy of behaviour change interventions for RP and identify what we can learn to inform future interventions.Methods and analysisStudies eligible for inclusion include randomised controlled trials testing behaviour change interventions with a control comparator. A comprehensive search strategy will include peer review and grey literature up until 30 April 2017. Search databases will include Medline, Embase, PsychINFO and Cochrane. Initial sifting, eligibility, data extraction, risk of bias and quality assessment will be subject to review by two independent reviewers with a third reviewer resolving discrepancies. Risk of bias assessment will be performed using Cochrane risk of a bias assessment tool with quality of evidence assessed using Grading of Recommendations Assessment, Development and Evaluation(GRADE). A meta-analysis will be performed if there are sufficient data. Two subgroup analyses are planned: primary versus secondary RP outcomes; comparison of theoretically informed interventions with pragmatic interventions.Ethics and disseminationThis review does not require ethical approval as it will summarise published studies with non-identifiable data. This protocol complies with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Findings will be disseminated in peer-reviewed articles and reported according to PRISMA. This review will make a significant contribution to the management of RP where no review of behaviour-change interventions currently exist. The synopsis and protocol for the proposed systematic review is registered in the International Prospective Register of Systematic Reviews (registration number CRD42017049643).
Population-based analysis of patients with COPD in Catalonia: a cohort study with implications for clinical management
Authors: Vela Emili , Tényi Ákos , Cano Isaac , Monterde David , Cleries Montserrat , Garcia-Altes Anna , Hernandez Carme , Escarrabill Joan , Roca Josep 
Published: December 2018

BackgroundClinical management of patients with chronic obstructive pulmonary disease (COPD) shows potential for improvement provided that patients’ heterogeneities are better understood. The study addresses the impact of comorbidities and its role in health risk assessment.ObjectiveTo explore the potential of health registry information to enhance clinical risk assessment and stratification.DesignFixed cohort study including all registered patients with COPD in Catalonia (Spain) (7.5 million citizens) at 31 December 2014 with 1-year (2015) follow-up.MethodsA total of 264 830 patients with COPD diagnosis, based on the International Classification of Diseases (Ninth Revision) coding, were assessed. Performance of multiple logistic regression models for the six main dependent variables of the study: mortality, hospitalisations (patients with one or more admissions; all cases and COPD-related), multiple hospitalisations (patients with at least two admissions; all causes and COPD-related) and users with high healthcare costs. Neither clinical nor forced spirometry data were available.ResultsMultimorbidity, assessed with the adjusted morbidity grouper, was the covariate with the highest impact in the predictive models, which in turn showed high performance measured by the C-statistics: (1) mortality (0.83), (2 and 3) hospitalisations (all causes: 0.77; COPD-related: 0.81), (4 and 5) multiple hospitalisations (all causes: 0.80; COPD-related: 0.87) and (6) users with high healthcare costs (0.76). Fifteen per cent of individuals with highest healthcare costs to year ratio represented 59% of the overall costs of patients with COPD.ConclusionsThe results stress the impact of assessing multimorbidity with the adjusted morbidity grouper on considered health indicators, which has implications for enhanced COPD staging and clinical management.Trial registration numberNCT02956395.