bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cancer and suicidal ideation and behaviours: protocol for a systematic review and meta-analysis
Authors: Calati Raffaella , Fang Fang , Mostofsky Elizabeth , Shen Qing , Di Mattei Valentina Elisabetta , Garcia-Foncillas Jesus , Baca-Garcia Enrique , Cipriani Andrea , Courtet Philippe 
Published: August 2018

IntroductionPrevalence of suicidal ideation (SI) and behaviours are higher among patients with cancer than general population. No systematic review/meta-analysis investigated this topic; therefore, our aim will be to assess the relationship between cancer and SI and behaviours.MethodsWe will search PubMed/MEDLINE, EMBASE, SCOPUS, Web of Science, PsycINFO and Cochrane Library databases from their inception until 30 June 2018. Case–control and cohort studies focused on the association between cancer (any type) and suicidal outcomes (suicide, suicide attempt and SI) will be included. Two team members will independently: (A) perform the selection of the included studies and data extraction, with the supervision of a third member in case of discrepancies and (B) assess each study with: (1) Newcastle-Ottawa Scale (NOS); (2) Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement; (3) Grading of Recommendations Assessment, Development and Evaluation (GRADE). We will conduct a random-effects meta-analysis. Individual and pooled ORs and associated 95% CIs will be calculated as well as between-study heterogeneity. We will examine the potential for publication bias. If possible, we will explore reasons for potential between-study heterogeneity.Ethics and disseminationThis study does not require ethical approval. The study will be submitted to a peer-reviewed journal, will be publicly disseminated and will be the topic of research presentations.PROSPERO registration numberCRD42017072482.
Combining online Community Reinforcement and Family Training (CRAFT) with a parent-training programme for parents with partners suffering from alcohol use disorder: study protocol for a randomised controlled trial
Authors: Lindner Philip , Siljeholm Ola , Johansson Magnus , Forster Martin , Andreasson Sven , Hammarberg Anders 
Published: August 2018

IntroductionPartners and children of individuals with alcohol use disorder (AUD) present with impaired quality of life and mental health, yet seldom seek or participate in traditional supportive interventions. Engaging the parent/partner without AUD in treatment is a promising way of supporting behavioural change in both the child and the parent with AUD. Universal parent-training (PT) programmes are effective in increasing children’s well-being and decreasing problem behaviours, but have yet to be tailored for children with a parent with AUD. Community Reinforcement Approach And Family Training (CRAFT) programmes are conceptually similar, and aim to promote behavioural change in individuals with AUD by having a concerned significant other change environmental contingencies. There has been no study on whether these two interventions can be combined and tailored for partners of individuals with AUD with common children, and delivered as accessible, online self-help.Methods and analysisn=300 participants with a child showing mental health problems and partner (co-parent) with AUD, but who do not themselves present with AUD, will be recruited from the general public and randomised 1:1 to either a four-module, online combined PT and CRAFT programme or a psychoeducation-only comparison intervention. Primary outcome will be the child’s mental health. Additional outcomes will cover the partner’s drinking, the participants own mental health and drinking, the child’s social adjustment, treatment seeking in all three parties and parental self-efficacy. Measures will be collected preintervention, mid-intervention and postintervention, and three times during a 2-year follow-up period. Data will be analysed using mixed-effects modelling.Ethics and disseminationThis study has been approved by the Stockholm Regional Ethical Review Board (2016/2179-31). The results will be presented at conferences and published as peer-reviewed publications.Trial registration numberISRCTN38702517; Pre-results.
Electronic patient-generated health data to facilitate prevention and health promotion: a scoping review protocol
Authors: Nittas Vasileios , Mütsch Margot , Ehrler Frederic , Puhan Milo Alan 
Published: August 2018

IntroductionRapidly expanding digital innovations transform the perception, reception and provision of health services. Simultaneously, health system challenges underline the need for patient-centred, empowering and citizen-engaging care, which facilitates a focus on prevention and health promotion. Through enhanced patient-engagement, patient-provider interactions and reduced information gaps, electronic patient-generated health data (PGHD) may facilitate both patient-centeredness and preventive scare. Despite that, comprehensive knowledge syntheses on their utilisation for prevention and health promotion purposes are lacking. The review described in this protocol aims to fill that gap.Methods and analysisOur methodology is guided by Arksey and O’ Malley’s methodological framework for scoping reviews, as well as its advanced version by Levac, Colquhoun and O’Brien. Seven electronic databases will be systematically searched using predefined keywords. Key electronic journals will be hand searched, while reference lists of included documents and grey literature sources will be screened thoroughly. Two independent reviewers will complete study selection and data extraction. One of the team’s senior research members will act as a third reviewer and make the final decision on disputed documents. We will include literature with a focus on electronic PGHD and linked to prevention and health promotion. Literature on prevention that is driven by existing discomfort or disability goes beyond the review’s scope and will be excluded. Analysis will be narrative and guided by Shapiroet al’s adapted framework on PGHD flow.Ethics and disseminationThe scoping review described in this protocol aims to establish a baseline understanding of electronic PGHD generation, collection, communication, sharing, interpretation, utilisation, context and impact for preventive purposes. The chosen methodology is based on the use of publicly available information and does not require ethical approval. Review findings will be disseminated in digital health conferences and symposia. Results will be published and additionally shared with relevant local and national authorities.
Evaluation of capillary pathologies by nailfold capillaroscopy in patients with psoriasis vulgaris: study protocol for a prospective, controlled exploratory study
Authors: Fink Christine , Kilian Samuel , Bertlich Ines , Hoxha Elti , Bardehle Felicitas , Enk Alexander , Haenssle Holger A 
Published: August 2018

IntroductionPsoriasis vulgaris was shown to be an independent factor increasing the risk of several comorbidities such as obesity, diabetes and dyslipidaemia with an increased risk of stroke and myocardial infarction. We hypothesise that early endothelial dysfunction, which plays a crucial role in the pathogenesis of atherosclerosis, may be detected by digital video nailfold capillaroscopy (DVNC) at the level of the dermal capillary microvasculature as a surrogate parameter. Nailfolds represent the only body site allowing for a non-invasive assessment of the capillary microvasculature at a horizontal plane. DVNC is a well-established diagnostic tool for in vivo assessment of the peripheral microcirculation by evaluating the morphology of dermal papillary capillaries. To date, reports on morphological changes of the non-lesional nailfold capillaries in patients with psoriasis vulgaris are scarce and the existing data are not conclusive.Methods and analysisThis is a prospective, single-centre, non-randomised, controlled, exploratory study assessing the capillary patterns in 100 subjects affected by psoriasis vulgaris. Non-lesional nailfold capillaries will be imaged by means of DVNC (Optilia Digital Capillaroscopy System, Optilia Instruments AB, Sollentuna, Sweden) in 50 patients affected by psoriasis vulgaris and 50 healthy controls. Assessments will include a qualitative, descriptive analysis of the nailfold capillaries’ morphology, as well as a quantitative investigation (frequency, extent) of changes in capillary patterns. Moreover, patients’ characteristics associated with the manifestation of nailfold capillaries’ pathologies including well-known cardiovascular risk markers will be studied.Ethics and disseminationEthical approval was provided by the ethic committee of the medical faculty of the University of Heidelberg (Ethics approval number S-447/2017). The design and the final results of the study will be published and made available to the public.Trial registration numberDRKS00012856.
Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy for advanced gastric cancer: study protocol for a randomised phase II trial
Authors: Li Ziyu , Shan Fei , Ying Xiangji , Zhang Lianhai , Ren Hui , Li Shuangxi , Jia Yongning , Miao Rulin , Xue Kan , Li Zhemin , Wang Yinkui , Yan Chao , Zhang Yan , Pang Fei , Ji Jiafu 
Published: August 2018

IntroductionCurrent guidelines recommend open gastrectomy with D2 lymph node dissection and adjuvant chemotherapy as the standard treatment for advanced gastric cancer. However, the prognosis is not satisfactory. Perioperative chemotherapy has been proposed to improve survival. Although still in debate, the efficacy of laparoscopic distal gastrectomy (LDG) in patients with advanced gastric cancer has been demonstrated in a few trials. Therefore, LDG after neoadjuvant chemotherapy can be a candidate for future standard treatment on advanced distal gastric cancer. We propose a randomised phase II trial to compare LDG and open distal gastrectomy (ODG) after neoadjuvant chemotherapy for advanced gastric cancer.Methods and analysisTo test the efficacy and safety, a randomised, open-label, single-centre, phase II trial was designed to evaluate the non-inferiority of LDG compared with ODG after neoadjuvant chemotherapy, with 3-year recurrence-free survival as the primary endpoint. The chosen critical value of a non-inferiority margin was an increase of <8%. The study started in 2015 and enrolled 96 patients according to a prior sample size calculation. Intention-to-treat and per-protocol approach will be used for efficacy analysis, and as-treated analysis will be applied for safety analysis. The survival curves will be constructed as time-to-event plots using the Kaplan-Meier method and compared using log-rank tests and Cox proportional hazards model. All statistical analyses will be conducted in standard statistical software with a significance level of 0.05.Ethics and disseminationThis study was approved by the Peking University Cancer Hospital Ethics Committee. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT02404753; Pre-results.
Cost-effectiveness of interventions for perinatal anxiety and/or depression: a systematic review
Authors: Camacho Elizabeth M , Shields Gemma E 
Published: August 2018

ObjectivesAnxiety and/or depression during pregnancy or year after childbirth is the most common complication of childbearing. Economic evaluations of interventions for the prevention or treatment of perinatal anxiety and/or depression (PAD) were systematically reviewed with the aim of guiding researchers and commissioners of perinatal mental health services towards potentially cost-effective strategies.MethodsElectronic searches were conducted on the MEDLINE, PsycINFO and NHS Economic Evaluation and Health Technology Assessment databases in September 2017 to identify relevant economic evaluations published since January 2000. Two stages of screening were used with prespecified inclusion/exclusion criteria. A data extraction form was designed prior to the literature search to capture key data. A published checklist was used to assess the quality of publications identified.ResultsOf the 168 non-duplicate citations identified, 8 studies met the inclusion criteria for the review; all but one focussing solely on postnatal depression in mothers. Interventions included prevention (3/8), treatment (3/8) or identification plus treatment (2/8). Two interventions were likely to be cost-effective, both incorporated identification plus treatment. Where the cost per quality-adjusted life year (QALY) gained was reported, interventions ranged from being dominant (cheaper and more effective than usual care) to costing £39 875/QALY.ConclusionsUncertainty and heterogeneity across studies in terms of setting and design make it difficult to make direct comparisons or draw strong conclusions. However, the two interventions incorporating identification plus treatment of perinatal depression were both likely to be cost-effective. Many gaps were identified in the economic evidence, such as the cost-effectiveness of interventions for perinatal anxiety, antenatal depression or interventions for fathers.PROSPERO registration numberCRD42016051133.
Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial
Authors: Casey Jonathan D , Janz David R , Russell Derek W , Vonderhaar Derek J , Joffe Aaron M , Dischert Kevin M , Brown Ryan M , Lester Michael G , Zouk Aline N , Gulati Swati , Stigler William S , Rice Todd W , Semler Matthew W 
Published: August 2018

IntroductionHypoxaemia is the most common complication during endotracheal intubation of critically ill adults, and it increases the risk of cardiac arrest and death. Manual ventilation between induction and intubation has been hypothesised to decrease the incidence of hypoxaemia, but efficacy and safety data are lacking.Methods and analysisThe Preventing Hypoxemia with Manual Ventilation during Endotracheal Intubation trial is a prospective, multicentre, non-blinded randomised clinical trial being conducted in seven intensive care units in the USA. A total of 400 critically ill adults undergoing endotracheal intubation will be randomised 1:1 to receive prophylactic manual ventilation between induction and endotracheal intubation using a bag-valve-mask device or no prophylactic ventilation. The primary outcome is the lowest arterial oxygen saturation between induction and 2 min after successful endotracheal intubation, which will be analysed as an unadjusted, intention-to-treat comparison of patients randomised to prophylactic ventilation versus patients randomised to no prophylactic ventilation. The secondary outcome is the incidence of severe hypoxaemia, defined as any arterial oxygen saturation of less than 80% between induction and 2 min after endotracheal intubation. Enrolment began on 2 February 2017 and is expected to be complete in May 2018.Ethics and disseminationThe trial was approved by the institutional review boards or designees of all participating centres. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.Trial registration numberNCT03026322; Pre-results.
Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial)
Authors: Sharma Saurab , Jensen Mark P , Moseley G Lorimer , Abbott J Haxby 
Published: August 2018

IntroductionLow back pain (LBP) is the leading cause of years lived with disability in Nepal and elsewhere. Management of LBP that is evidence-based, easily accessible, cost-effective and culturally appropriate is desirable. The primary aim of this feasibility study is to determine if it is feasible to conduct a full randomised clinical trial evaluating the effectiveness of pain education as an intervention for individuals with LBP in Nepal, relative to guideline-based physiotherapy treatment. The findings of the study will inform the planning of a full clinical trial and if any modifications are required to the protocol before undertaking a full trial.Methods/analysisThis protocol describes an assessor-blinded feasibility clinical trial investigating feasibility of the pain education intervention in patients with non-specific LBP in a physiotherapy hospital in Kathmandu, Nepal. Forty patients with LBP will be randomly allocated to either pain education or guideline-based physiotherapy treatment (control). Outcomes will be assessed at baseline and at a 1 week post-treatment. The primary outcomes are related to feasibility, including: (1) participant willingness to participate in a randomised clinical trial, (2) feasibility of assessor blinding, (3) eligibility and recruitment rates, (4) acceptability of screening procedures and random allocation, (5) possible contamination between the groups, (6) intervention credibility, (7) intervention adherence, (8) treatment satisfaction and (9) difficulty in understanding the interventions being provided.Ethics/disseminationThe protocol was approved by Nepal Health Research Council (NHRC; registration number: 422/2017) and University of Otago Human Ethics Committee for Health (registration number: H17/157). The results of the study will be presented at national and international conferences and published in a peer-reviewed journal.Trial registration numberNCT03387228; Pre-results.
Meanings of ‘centredness’ in long-term care facilities: a scoping review protocol
Authors: Thompson Genevieve , Shindruk Chloe Lyn , Adekoya Adebusola Abiodun , Demczuk Lisa , McClement Susan 
Published: August 2018

IntroductionThere is a growing demand for long-term care services for older adults that embrace a model of care centred on individual recipients of care. In long-term care, models of person, resident and relationship-centred care have been developed and implemented to promote independence, decision making and choices of residents. Although the concepts of centredness have been readily adopted in these environments, what constitutes centredness is often vague and lacks conceptual clarity and definition. The research questions guiding this scoping review are: (1) What are the defining attributes, conceptual boundaries and theoretical underpinnings of each centredness term in long-term care? (2) For what purposes have centredness directed models of care been used in this context? (3) What types of study designs have been used to examine centredness in this context? (4) What outcomes related to centredness have been reported or evaluated and how were they measured in long-term care?Methods and analysisThis review uses the methodological framework for conducting a scoping review by Arksey and O’Malley. The search strategy will be applied to nine bibliographic and citation databases, Google Scholar and the grey literature. Study selection will occur in a two-step process. First, the titles and abstracts of all search results will be screened by individual reviewers. Second, a full-text review will be conducted by a pair of reviewers. To be included articles must (1) define centredness in the context of long-term care; (2) describe the defining features of centredness; (3) explore the theoretical underpinnings of centredness; (4) outline outcomes of centredness or (5) use outcome measures related to centredness. Data will be extracted from included studies and analysed using thematic analysis as described by Braun and Clark.Ethics and disseminationResearch ethics approval is not required for this scoping review. Dissemination strategies will follow a targeted and tailored approach based on study findings.
Protocol paper for the ‘Harnessing resources from the internet to maximise outcomes from GP consultations (HaRI)’ study: a mixed qualitative methods study
Authors: Seguin Maureen , Hall Laura , Atherton Helen , Barnes Rebecca , Leydon Geraldine , Murray Elizabeth , Pope Catherine , Ziebland Sue , Stevenson Fiona A 
Published: August 2018

IntroductionMany patients now turn to the internet as a resource for healthcare information and advice. However, patients’ use of the internet to manage their health has been positioned as a potential source of strain on the doctor–patient relationship in primary care. The current evidence about what happens when internet-derived health information is introduced during consultations has relied on qualitative data derived from interview or questionnaire studies. The ‘Harnessing resources from the internet to maximise outcomes from GP consultations (HaRI)’ study combines questionnaire, interview and video-recorded consultation data to address this issue more fully.Methods and analysisThree data collection methods are employed: preconsultation patient questionnaires, video-recorded consultations between general practitioners (GP) and patients, and semistructured interviews with GPs and patients. We seek to recruit 10 GPs practising in Southeast England. We aim to collect up to 30 patient questionnaires and video-recorded consultations per GP, yielding up to 300. Up to 30 patients (approximately three per participating GP) will be selected for interviews sampled for a wide range of sociodemographic characteristics, and a variety of ways the use of, or information from, the internet was present or absent during their consultation. We will interview all 10 participating GPs about their views of online health information, reflecting on their own usage of online information during consultations and their patients’ references to online health information. Descriptive, conversation and thematic analysis will be used respectively for the patient questionnaires, video-recorded consultations and interviews.Ethics and disseminationEthical approval has been granted by the London–Camden & Kings Cross Research Ethics Committee. Alongside journal publications, dissemination activities include the creation of a toolkit to be shared with patients and doctors, to guide discussions of material from the internet in consultations.