bluuebunny/crossref_metadata_2025_split huggingface dataset:
The impact of patient-held health records on continuity of care among asylum seekers in reception centres: a cluster-randomised stepped wedge trial in Germany
Authors: Straßner Cornelia , Noest Stefan , Preussler Stella , Jahn Rosa , Ziegler Sandra , Wahedi Katharina , Bozorgmehr Kayvan 
Published: August 2019

IntroductionThe aim of this study was to assess the effectiveness of a patient-held health record (PHR) for asylum seekers on the availability of health-related information.MethodsAn explorative, cluster-randomised stepped-wedge trial with reception centres as unit of randomisation was conducted. All reception centres (n=6) in two large administrative areas in South Germany with on-site health services were included. All physicians working at these centres were invited to participate in the study. The intervention was the implementation of a PHR. The primary outcome was the prevalence of written health-related information. Secondary outcomes were the physicians’ dissatisfaction with the available written information and the prevalence of missing health-related information. All outcomes were measured at the level of patient–physician contacts by means of a standardised questionnaire, and analysed in logistic multi-level regression models.ResultsWe obtained data on 2308 patient–physician contacts. The presence of the PHR increased the availability of health-related information (adjusted OR (aOR), 20.3, 95% CI: 12.74 to 32.33), and tended to reduce missing essential information (aOR 0.71, 95% CI: 0.39 to 1.26) and physicians’ dissatisfaction with available information (aOR 0.5, 95% CI: 0.24 to 1.04). The availability of health-related information in the post-intervention period was higher (aOR 4.22, 95% CI: 2.64 to 6.73), missing information (aOR 0.89, 95% CI: 0.42 to 1.88) and dissatisfaction (aOR 0.43, 95% CI: 0.16 to 1.14) tended to be lower compared with the pre-intervention period.ConclusionsHealthcare planners should consider introducing PHRs in reception centres or comparable facilities. Future research should focus on the impact of PHRs on clinical outcomes and on intersectoral care.Trial registrationISRCTN13212716. Registered 24 November 2016. Retrospectively registered.http://www.isrctn.com/ISRCTN13212716
Home-based rehabilitation for heart failure with reduced ejection fraction: mixed methods process evaluation of the REACH-HF multicentre randomised controlled trial
Authors: Frost Julia , Wingham Jennifer , Britten Nicky , Greaves Colin , Abraham Charles , Warren Fiona C , Jolly Kate , Doherty Patrick Joseph , Miles Jackie , Singh Sally J , Paul Kevin , Taylor Rod , Dalal Hasnain 
Published: August 2019

ObjectiveTo identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives.DesignMixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care).SettingFour centres in the UK (Birmingham, Cornwall, Gwent and York).ParticipantsPeople with heart failure with reduced ejection fraction (HFrEF) and their caregivers.MethodsThe REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers.Outcome measuresQuantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers.ResultsIntervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents’ comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.ConclusionsBy combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention.Trial registration numberISRCTN25032672; Pre-results.
GETUG-AFU 31: a phase I/II multicentre study evaluating the safety and efficacy of salvage stereotactic radiation in patients with intraprostatic tumour recurrence after external radiation therapy—study protocol
Authors: Pasquier David , Le Deley Marie-Cécile , Tresch Emmanuelle , Cormier Luc , Duterque Martine , Nenan Soazig , Lartigau Eric 
Published: August 2019

IntroductionProstate cancer is the third most important cancer in terms of mortality in men. No standard local treatment exists for patients with an intraprostatic recurrence after radiotherapy. Stereotatic body radiotherapy (SBRT) could be a curative treatment for local recurrence. The phase I/II primary objective is the selection of the recommended dose for salvage-SBRT and to estimate the efficacy.Methods and analysisWe plan to perform a multicentre prospective phase I/II study including at least 47 patients. Eligible patients are patients with biochemical recurrence occurring at least 2 years after external radiotherapy for prostatic adenocarcinoma by the Phoenix definition (prostate-specific antigen (PSA) nadir +2 ng/mL) and histologically proven intraprostatic recurrence only (stage T1-T2 on relapse, PSA level ≤10 ng/mL, PSA doubling time >10 months, absence of pelvic or metastatic recurrence proven by choline or PSMA positron emission tomography scan, and pelvic and prostatic assessment by multiparametric MRI). The phase I primary objective is the selection of the recommended dose for salvage-SBRT (5×6, 6×6 or 5×5 Gy) based on dose-limiting toxicity (DLT). The dose of salvage-SBRT will be selected using a time-to-event continual reassessment method based on DLT defined as grade ≥3 gastrointestinal or urinary toxicity or any other grade 4 adverse event. The phase II primary outcome is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate (Phoenix definition: increase in serum total PSA ≥2 ng/mL above the nadir). Phase II secondary outcomes are acute and late toxicities, quality of life, clinical progression-free survival defined as the time interval between the date of registration and the date of clinical progression or death irrespective of the cause.Ethics and disseminationThe study has received ethical approval from the Ethics committee ‘Ile-de-France III’. Academic dissemination will occur through publication and conference presentations.Trial registration numberNCT03438552
A protocol for a discrete choice experiment: understanding patient medicine preferences for managing chronic non-cancer pain
Authors: Shanahan Marian , Larance Briony , Nielsen Suzanne , Cohen Milton , Schaffer Maria , Campbell Gabrielle 
Published: August 2019

IntroductionHigh rates of chronic non-cancer pain (CNCP), concerns about adverse effects including dependence among those prescribed potent pain medicines, the recent evidence supporting active rather than passive management strategies and a lack of funding for holistic programme have resulted in challenges around decision making for treatment among clinicians and their patients. Discrete choice experiments (DCEs) are one way of assessing and valuing treatment preferences. Here, we outline a protocol for a study that assesses patient preferences for CNCP treatment.Methods and analysisA final list of attributes (and their levels) for the DCE was generated using a detailed iterative process. This included a literature review, a focus group and individual interviews with those with CNCP and clinicians who treat people with CNCP. From this process a list of attributes was obtained. Following a review by study investigators including pain and addiction specialists, pharmacists and epidemiologists, the final list of attributes was selected (number of medications, risk of addiction, side effects, pain interference, activity goals, source of information on pain, provider of pain care and out-of-pocket costs). Specialised software was used to construct an experimental design for the survey. The survey will be administered to two groups of participants, those from a longitudinal cohort of patients receiving opioids for CNCP and a convenience sample of patients recruited through Australia’s leading pain advocacy body (Painaustralia) and their social media and website. The data from the two participant groups will be initially analysed separately, as their demographic and clinical characteristics may differ substantially (in terms of age, duration of pain and current treatment modality). Mixed logit and latent class analysis will be used to explore heterogeneity of responses.Ethics and disseminationEthics approval was obtained from the University of New South Wales Sydney Human Ethics committee HC16511 (for the focus group discussions, the one-on-one interviews and online survey) and HC16916 (for the cohort). A lay summary will be made available on the National Drug and Alcohol Research Centre website and Painaustralia’s website. Peer review papers will be submitted, and it is expected the results will be presented at relevant pain management conferences nationally and internationally. These results will also be used to improve understanding of treatment goals between clinicians and those with CNCP.
Effect of high-flow nasal cannula oxygen therapy compared with conventional oxygen therapy in postoperative patients: a systematic review and meta-analysis
Authors: Lu Zhonghua , Chang Wei , Meng Shan-Shan , Zhang Xiwen , Xie Jianfeng , Xu Jing-Yuan , Qiu Haibo , Yang Yi , Guo Fengmei 
Published: August 2019

ObjectiveTo evaluate the effect of high-flow nasal cannula oxygen therapy (HFNC) versus conventional oxygen therapy (COT) on the reintubation rate, rate of escalation of respiratory support and clinical outcomes in postextubation adult surgical patients.DesignSystematic review and meta-analysis of published literature.Data sourcesPubMed, Embase, the Cochrane Library, Web of Science, China National Knowledge Index and Wan fang databases were searched up to August 2018.Eligibility criteriaStudies in postoperative adult surgical patients (≥18 years), receiving HFNC or COT applied immediately after extubation that reported reintubation, escalation of respiratory support, postoperative pulmonary complications (PPCs) and mortality were eligible for inclusion.Data extraction and synthesisThe following data were extracted from the included studies: first author’s name, year of publication, study population, country of origin, study design, number of patients, patients’ baseline characteristics and outcomes. Associations were evaluated using risk ratio (RR) and 95% CIs.ResultsThis meta-analysis included 10 studies (1327 patients). HFNC significantly reduced the reintubation rate (RR 0.38, 95% CI 0.23 to 0.61, p<0.0001) and rate of escalation of respiratory support (RR 0.43, 95% CI 0.26 to 0.73, p=0.002) in postextubation surgical patients compared with COT. There were no differences in the incidence of PPCs (RR 0.87, 95% CI 0.70 to 1.08, p=0.21) or mortality (RR 0.45, 95% CI 0.16 to 1.29, p=0.14).ConclusionHFNC is associated with a significantly lower reintubation rate and rate of escalation of respiratory support compared with COT in postextubation adult surgical patients, but there is no difference in the incidence of PPCs or mortality. More well-designed, large randomised controlled trials are needed to determine the subpopulation of patients who are most likely to benefit from HFNC therapy.
Comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group
Authors: Athanasiou Antonios , Veroniki Areti Angeliki , Efthimiou Orestis , Kalliala Ilkka , Naci Huseyin , Bowden Sarah , Paraskevaidi Maria , Martin-Hirsch Pierre , Bennett Philip , Paraskevaidis Evangelos , Salanti Georgia , Kyrgiou Maria 
Published: August 2019

IntroductionLocal treatments for cervical intraepithelial neoplasia (CIN) and microinvasive disease remove or ablate a cone-shaped part of the uterine cervix containing the abnormal cells. A trend toward less radical techniques has raised concerns that this may adversely impact the rates of precancerous and cancerous recurrence. However, there has been no strong evidence to support such claims. We hereby describe a protocol of a systematic review and network meta-analysis that will update the evidence and compare all relevant treatments in terms of efficacy and complications.Methods and analysisLiterature searches in electronic databases (CENTRAL, MEDLINE, EMBASE) or trial registries will identify published and unpublished randomised controlled trials (RCTs) and cohort studies comparing the efficacy and complications among different excisional and ablative techniques. The excisional techniques include cold knife, laser or Fischer cone, large loop or needle excision of the transformation zone and the ablative radical point diathermy, cryotherapy, cold coagulation or laser ablation. The primary outcome will be residual/recurrent disease defined as abnormal histology or cytology of any grade, while secondary outcomes will include treatment failure rates defined as high-grade histology or cytology, histologically confirmed CIN1+ or histologically confirmed CIN2+, human papillomavirus positivity rates, involved margins rates, bleeding and cervical stenosis rates. We will assess the risk of bias in RCTs and observational studies using tools developed by the Cochrane Collaboration. Two authors will independently assess study eligibility, abstract the data and assess the risk of bias. Random-effects meta-analyses and network meta-analyses will be conducted using the OR for dichotomous outcomes and the mean difference for continuous outcomes. The quality of the evidence for the primary outcome will be assessed using the CINeMA (Confidence In Network Meta-Analysis) tool.Ethics and disseminationEthical approval is not required. We will disseminate findings to clinicians, policy-makers, patients and the public.PROSPERO registration numberCRD42018115508.
Symptom screening in paediatrics tool for screening multiple symptoms in Brazilian patients with cancer: a cross-sectional validation study
Authors: Cadamuro Sandra de Andrade , Franco Julia Onishi , Paiva Carlos Eduardo , de Oliveira Cleyton Zanardo , Paiva Bianca Sakamoto Ribeiro 
Published: August 2019

ObjectiveThe objective of this study was to translate, culturally adapt and validate the Symptom Screening in Paediatrics Tool (SSPedi) into the Brazilian Portuguese language to be used by paediatric oncology patients in Brazil.DesignA descriptive, cross-sectional study that follows an established methodology for translation and cultural adaptation, developed in two phases: phase I, linguistic translation and cultural adaptation of the SSPedi scale and phase II, psychometric properties evaluation.SettingChildren’s Hospital for Cancer Treatment in Latin America.ParticipantsPaediatric patients between 7 and 18 years of age and proxies of patients between 2 and 6 years of age, diagnosed with cancer and undergoing chemotherapy treatment. Patients and proxies with significant neuropsychiatric disorders and/or visual impairment that prevented the ability to read were excluded.Primary outcome measuresConstruct validation of SSPedi using convergent validity and contrasted groups. Reliability was evaluated using Cronbach’s alpha test and assessing the retest using the intraclass correlation coefficient (ICC).ResultsThe psychometric properties of the symptom screening tool were evaluated using 157 participants, of which 116 were patients and 41 were proxies. Convergent validity and hypothesised correlations (Spearman’s r>0.4) were confirmed for both self- and proxy-reported versions of the assessment tool. No significant differences found between the two contrasting groups. Assessment of SSPedi resulted in an internal consistency of reliability of α=0.77 (95% CI 0.70 to 0.82) for the self and α=0.81 (95% CI 0.71 to 0.88) for the proxy and overall reproducibility ICC values of (95% CI), 0.54 (0.15 to 0.77) and 0.77 (0.64 to 0.86).ConclusionSSPedi was found to be culturally and linguistically adaptable and considered valid and reliable for use by paediatric oncology patients in Brazil. The new translated and adapted version was named SSPedi-BR.
Transition program for adolescents with congenital heart disease in transition to adulthood: protocol for a mixed-method process evaluation study (the STEPSTONES project)
Authors: Saarijärvi Markus , Wallin Lars , Moons Philip , Gyllensten Hanna , Bratt Ewa-Lena 
Published: August 2019

IntroductionToday, the majority of young persons living with chronic conditions in high-income countries survive into adulthood and will need life-long medical follow-up. Therefore, transition programmes have been developed to facilitate transfer to adult care, and to support self-management and independence during adulthood. The Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES) project aims to evaluate the effectiveness of a person-centred transition programme for empowering adolescents with congenital heart disease in transition to adulthood. To understand how the transition programme causes change and how outcomes are created, process evaluation is imperative to assess implementation, context and mechanisms of impact. This protocol aims to describe the process evaluation of the STEPSTONES transition programme.Methods and designMedical Research Council guidance for process evaluation of complex interventions will be the guiding framework for this mixed-method study. The combination of qualitative and quantitative data will capture different aspects of programme delivery. The sample will consist of participants in the STEPSTONES randomised controlled trial (RCT), persons implementing the programme and healthcare professionals. Quantitative data will consist of protocols and routine monitoring documents from the RCT, data collected from patient registries and sociodemographic data to assess the implementation of the intervention. This data will be analysed with quantitative content analysis, along with descriptive and inferential statistics. Qualitative data will consist of participatory observations, logbooks and interviews with persons implementing the programme, participants and healthcare professionals. Analyses will be performed using qualitative content analysis to investigate mechanism of impact, context and delivery. Quantitative and qualitative data will be integrated in the final stage by using a triangulation protocol according to mixed-method guidelines.Ethics and disseminationThe study is approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be presented in open access, peer-reviewed journals and at international scientific conferences.
Outcome and comparator choice in molar incisor hypomineralisation (MIH) intervention studies: a systematic review and social network analysis
Authors: Elhennawy Karim , Krois Joachim , Jost-Brinkmann Paul-Georg , Schwendicke Falk 
Published: August 2019

ObjectivesOutcome and comparator choice strongly determine the validity and implementation of clinical trial results. We aimed to assess outcome and comparator choice in intervention studies on molar incisor hypomineralisation (MIH) using systematic review and social network analysis (SNA).Design and data sourcesMedline, Embase, Cochrane Central, Google Scholar, opengrey.eu as well as DRKS.de and Clinicaltrials.gov were searched for MIH intervention studies. The search covered the period from 1980 to 2019.Eligibility criteriaClinical single-arm/multiarm, controlled/uncontrolled studies reporting on the management of MIH were included. Reported outcomes and comparators were extracted and categorised. SNA was used to evaluate comparator choice and the resulting trial networks.Data extractionOf the 7979 identified records, 100 were evaluated in full text and 35 studies (17 randomised controlled trials, 14 prospective and 4 retrospective cohort studies) were included.ResultsIn total, 2124 patients with a mean age of 11 years (min/max 6/70 years) were included. Outcomes fell in one of 11 different outcome categories: restoration success, aesthetic improvement, pain/hypersensitivity/discomfort, mineral gain, space management, anaesthesia effectiveness, preventive success, efficiency, quality of life, gingival and periodontal health and patient satisfaction. Comparators were mainly restorative interventions (17 studies), remineralisation (3), treatment of hypersensitivity (10), aesthetic interventions (5) and orthodontic interventions (3). Two highly clustered comparator networks emerged; many interventions were not robustly linked to these networks.ConclusionsMIH intervention studies recorded both clinically centred and patient-centred outcomes. Core outcome set development should consider these and supplement them with outcomes on, for example, applicability. The high number of compared interventions tested in only few studies and our SNA results implicate that the current evidence may not be robust.