bluuebunny/crossref_metadata_2025_split huggingface dataset:
Organisational context of hospitals that participated in a multi-site mentored medication reconciliation quality improvement project (MARQUIS2): a cross-sectional observational study
Authors: Stolldorf Deonni P , Schnipper Jeffrey L , Mixon Amanda S , Dietrich Mary , Kripalani Sunil 
Published: November 2019

ObjectivesMedication reconciliation (MedRec) is an important patient safety strategy and is widespread in US hospitals and globally. Nevertheless, high quality MedRec has been difficult to implement. As part of a larger study investigating MedRec interventions, we evaluated and compared organisational contextual factors and team cohesion by hospital characteristics and implementation team members’ profession to better understand the environmental context and its correlates during a multi-site quality improvement (QI) initiative.DesignWe conducted a cross-sectional observational study using a web survey (contextual factors) and a national hospital database (hospital characteristics).SettingHospitals participating in the second Multi-Centre Medication Reconciliation Quality Improvement Study (MARQUIS2).ParticipantsImplementation team members of 18 participating MARQUIS2 hospitals.OutcomesPrimary outcome: contextual factor ratings (ie, organisational capacity, leadership support, goal alignment, staff involvement, patient safety climate and team cohesion). Secondary outcome: differences in contextual factors by hospital characteristics.ResultsFifty-five team members from the 18 participating hospitals completed the survey. Ratings of contextual factors differed significantly by domain (p<0.001), with organisational capacity scoring the lowest (mean=4.0 out of 7.0) and perceived team cohesion and goal alignment scoring the highest (mean~6.0 out of 7.0). No statistically significant differences were observed in contextual factors by hospital characteristics (p>0.05). Respondents in the pharmacy profession gave lower ratings of leadership support than did those in the nursing or other professions group (p=0.01).ConclusionsHospital size, type and location did not drive differences in contextual factors, suggesting that tailoring MedRec QI implementation to hospital characteristics may not be necessary. Strong team cohesion suggests the use of interdisciplinary teams does not detract from cohesion when conducting mentored QI projects. Organisational leaders should particularly focus on supporting pharmacy services and addressing their concerns during MedRec QI initiatives. Future research should correlate contextual factors with implementation success to inform how best to prepare sites to implement complex QI interventions such as MedRec.
Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study
Authors: Keene David J , Costa Matthew L , Tutton Elizabeth , Hopewell Sally , Barber Vicki S , Dutton Susan J , Redmond Anthony C , Willett Keith , Lamb Sarah E 
Published: November 2019

IntroductionAnkle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6 month follow-up.Methods and analysisA multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.Ethics and disseminationHampshire B Research Ethics Committee (18/SC/0281) gave approval on 2ndJuly 2018.Trial registration numberISRCTN16612336
Prospective, observational study to evaluate the relation between patient-reported outcomes and component rotation in total knee replacement: protocol for the CRACK study
Authors: van Jonbergen Hans-Peter , Landman Ellie , Horst Maarten , Westerbeek Robin , Kleinlugtenbelt Ydo 
Published: November 2019

IntroductionTotal knee replacement (TKR) for osteoarthritis results in a satisfactory outcome in the majority of patients, although up to one in five patients may be dissatisfied with the outcome. Persistent pain is a main contributor to patient dissatisfaction, and femoral and tibial component malrotation have been identified as a potential cause for both persistent pain and patellofemoral problems. Based on the assumption that component malrotation is the causative factor for persistent pain, early revision for patients with symptomatic malrotated components has been advocated in the literature. However, convincing evidence that component malrotation indeed results in less than optimal outcomes is lacking. This study aims to assess the relation between knee prosthesis component rotation and patient-reported outcomes in a large group of patients and to determine the range of femoral, tibial and combined rotation that results in the best clinical outcomes.Methods and analysisIn this single-centre, prospective observational cohort study, a total of 500 patients will undergo TKR. All patients will have a 3D-CT assessment of femoral and tibial component rotation within 8 weeks after surgery. Outcome measures will include the Oxford Knee Score, the Knee Injury and Osteoarthritis Outcome Score, EQ-5D, visual analogue scale for pain, the American Knee Society Score and the knee joint range of motion. We will assess the relation between femoral, tibial and combined component rotation and patient-reported outcome measures at 8 weeks and 1 year of follow-up, and we will determine the range of femoral, tibial and combined rotation that results in the best clinical outcomes.Ethics and disseminationEthical approval for this study has been granted by the Isala Hospital ethics committee. The results will be published in a peer-reviewed journal and presented at relevant meetings.Trial registration numberNL7635.
Protocol for a randomised controlled trial of the combined effects of the GLP-1 receptor agonist liraglutide and exercise on maintenance of weight loss and health after a very low-calorie diet
Authors: Jensen Simon Birk Kjær , Lundgren Julie Rehné , Janus Charlotte , Juhl Christian Rimer , Olsen Lisa Møller , Rosenkilde Mads , Holst Jens Juul , Stallknecht Bente Merete , Madsbad Sten , Torekov Signe Sørensen 
Published: November 2019

IntroductionThe success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by 1-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise or the combination of both treatments as compared with placebo in individuals with obesity.Methods and analysisThis is an investigator-initiated, randomised, placebo-controlled, parallel group trial. We will enrol expectedly 200 women and men (age 18–65 years) with obesity (body mass index 32–43 kg/m2) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight. Subsequently, participants will be randomised in a 1:1:1:1 ratio to one of four study groups for 52 weeks: (1) placebo, (2) exercise 150 min/week+placebo, (3) liraglutide 3.0 mg/day and (4) exercise 150 min/week+liraglutide 3.0 mg/day. The primary endpoint is change in body weight from randomisation to end-of-treatment.Ethics and disseminationThe trial has been approved by the ethical committee of the Capital Region of Denmark and the Danish Medicines Agency. The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.Trial registration number2015-005585-32
Impact of repeat flooding on mental health and health-related quality of life: a cross-sectional analysis of the English National Study of Flooding and Health
Authors: French Clare E , Waite Thomas D , Armstrong Ben , Rubin G. James ,   English National Study of Flooding and Health Study Group, Beck Charles R , Oliver Isabel 
Published: November 2019

ObjectiveTo assess the association between flooding/repeat flooding and: (1) psychological morbidity (anxiety, depression, post-traumatic stress disorder (PTSD)) and (2) health-related quality of life (HRQoL) at 6 months post-flooding.DesignCross-sectional analysis of data from the English National Study of Flooding and Health.SettingCumbria, England.ParticipantsQuestionnaires were sent to 2500 residential addresses at 6 months post-flooding; 590 people responded.OutcomesProbable depression was assessed using the Patient Health Questionnaire, probable anxiety using the Generalised Anxiety Disorder scale and probable PTSD using the short-form PTSD checklist (PCL-6). HRQoL was assessed using the EQ-5D-5L. Mental health outcomes were analysed using logistic regression; HRQoL dimensions using ordinal regression; and summary index/Visual Analogue Scale scores using linear regression.ResultsOne hundred and nineteen participants had been flooded, over half of whom were experiencing a repeat flooding event (54%; n=64). Mental health outcomes were elevated among flooded compared with unaffected participants (adjusted OR for probable depression: 7.77, 95% CI: 1.51 to 40.13; anxiety: 4.16, 95% CI: 1.18 to 14.70; PTSD: 14.41, 95% CI: 3.91 to 53.13). The prevalence of depression was higher among repeat compared with single flooded participants, but this was not significant after adjustment. There was no difference in levels of anxiety or PTSD. Compared with unaffected participants, those flooded had lower EQ-5D-5L index scores (adjusted coefficient: −0.06, 95% CI: −0.12 to −0.01) and lower self-rated health scores (adjusted coefficient: −6.99, 95% CI: −11.96 to −2.02). There was, however, little difference in HRQoL overall between repeat and single flooded participants.ConclusionsInterventions are needed to help minimise the impact of flooding on people’s mental health and HRQoL.
Developing patient-centred, feasible alternative care for adult emergency department users with epilepsy: protocol for the mixed-methods observational ‘Collaborate’ project
Authors: Noble Adam J , Mathieson Amy , Ridsdale Leone , Holmes EA , Morgan Myfanwy , McKinlay Alison , Dickson Jon Mark , Jackson Mike , Hughes Dyfrig A , Goodacre Steve , Marson Anthony G 
Published: November 2019

IntroductionEmergency department (ED) visits for epilepsy are common, costly, often clinically unnecessary and typically lead to little benefit for epilepsy management. An ‘Alternative Care Pathway’ (ACP) for epilepsy, which diverts people with epilepsy (PWE) away from ED when ‘999’ is called and leads to care elsewhere, might generate savings and facilitate improved ambulatory care. It is unknown though what features it should incorporate to make it acceptable to persons from this particularly vulnerable target population. It also needs to be National Health Service (NHS) feasible. This project seeks to identify the optimal ACP configuration.Methods and analysisMixed-methods project comprising three-linked stages. In Stage 1, NHS bodies will be surveyed on ACPs they are considering and semi-structured interviews with PWE and their carers will explore attributes of care important to them and their concerns and expectations regarding ACPs. In Stage 2, Discrete Choice Experiments (DCE) will be completed with PWE and carers to identify the relative importance placed on different care attributes under common seizure scenarios and the trade-offs people are willing to make. The uptake of different ACP configurations will be estimated. In Stage 3, two Knowledge Exchange workshops using a nominal group technique will be run. NHS managers, health professionals, commissioners and patient and carer representatives will discuss DCE results and form a consensus on which ACP configuration best meets users’ needs and is NHS feasible.Ethics and disseminationEthical approval: NRES Committee (19/WM/0012) and King’s College London ethics Committee (LRS-18/19-10353). Primary output will be identification of optimal ACP configuration which should be prioritised for implementation and evaluation. A pro-active dissemination strategy will make those considering developing or supporting an epilepsy ACP aware of the project and opportunities to take part in it. It will also ensure they are informed of its findings.Project registration numberResearchregistry4723.
Primary prevention of stroke: randomised controlled pilot trial protocol on engaging everyday activities promoting health
Authors: Patomella Ann-Helen , Guidetti Susanne , Mälstam Emelie , Eriksson Christina , Bergström Aileen , Åkesson Elisabet , Kottorp Anders , Asaba Eric 
Published: November 2019

IntroductionStroke is a globally common disease that has detrimental effects on the individual and, more broadly, on society. Lifestyle change can contribute to reducing risk factors for stroke. Although a healthy lifestyle has direct benefits, sustaining and incorporating healthy activities into everyday life is a challenge. Engaging everyday activities have the potential to support lifestyle change and to promote sustainable activity patterns. Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies. The aim of the pilot study was to increase knowledge about the effects of a prevention programme and its feasibility to promote sustainable and healthy activity patterns among persons at risk of stroke.Methods and analysisThe proposed pilot study will be a two-armed randomised, assessor-blinded, parallel pilot trial. The study will include feasibility data, investigating acceptability and delivery of the intervention. Persons at risk of stroke (n=60) will be included in a mobile phone-supported prevention programme. The 10-week programme will be conducted at primary healthcare clinics, combining group meetings and online resources to support self-management of lifestyle change. Main outcomes are stroke risk, lifestyle habits and healthy activity patterns. Assessments will be performed at baseline and at follow-up (immediately following the end of the programme and at 6 and 12 months). Effects of the programme will be analysed using inferential statistics. Feasibility will be analysed using both qualitative and quantitative methods.Ethics and disseminationThe study has been approved by the Regional Ethical Review Board in Stockholm, Sweden, being granted reference numbers 2015/834-31, 2016/2203-32 and 2019/01444. Study results will be disseminated through peer-review journals and presentations to mixed audiences at regional and international conferences.Trial registration numberNCT03730701.
Determinants of vaccine hesitancy in Switzerland: study protocol of a mixed-methods national research programme
Authors: Deml Michael J. , Jafflin Kristen , Merten Sonja , Huber Benedikt , Buhl Andrea , Frau Eleonora , Mettraux Valérie , Sonderegger Joanna , Kliem Paulina , Cattalani Rachele , Krüerke Daniel , Pfeiffer Constanze , Burton-Jeangros Claudine , Tarr Philip E. 
Published: November 2019

IntroductionVaccine hesitancy is a complex public health issue referring to concerns about the safety, efficacy or need for vaccination. Relatively little is known about vaccine hesitancy in Switzerland. This ongoing study (2017–2021) focuses on biomedical and complementary and alternative medicine (CAM) providers and their patients since healthcare professionals play important roles in vaccination decision-making. This national research programme seeks to assess the sociocultural determinants of vaccine hesitancy regarding childhood and human papillomavirus vaccines in Switzerland. We aim to provide a detailed characterisation of vaccine hesitancy, including CAM and biomedical perspectives, patient–provider interactions, and sociocultural factors, to establish the mediating effects of vaccine hesitancy on underimmunisation, and to design an intervention to improve vaccination communication and counselling among physicians, parents and adolescents.Methods and analysisOur transdisciplinary team employs a sequential exploratory mixed-methods study design. We have established a network of more than 150 medical providers across Switzerland, including more than 40 CAM practitioners. For the qualitative component, we conduct interviews with parents, youth, and biomedical and CAM providers and observations of vaccination consultations and school vaccination information sessions. For the quantitative component, a sample of 1350 parents of young children and 722 young adults (15–26 years) and their medical providers respond to questionnaires. We measure vaccine hesitancy with the Parent Attitudes about Childhood Vaccines 15-item survey and review vaccination certificates to assess vaccination status. We administer additional questions based on findings from qualitative research, addressing communication with medical providers, vaccine information sources and perceptions of risk control vis-à-vis vaccine-preventable diseases. The questionnaires capture sociodemographics, political views, religion and spirituality, and moral foundations.Ethics and disseminationThe study was approved by the local ethics committee. The results will be published in peer-reviewed journals and disseminated to healthcare professionals, researchers and the public via conferences and public presentations.
Systematic review of behavioural smoking cessation interventions for older smokers from deprived backgrounds
Authors: Smith Pamela , Poole Ria , Mann Mala , Nelson Annmarie , Moore Graham , Brain Kate 
Published: November 2019

IntroductionThe associations between smoking prevalence, socioeconomic group and lung cancer outcomes are well established. There is currently limited evidence for how inequalities could be addressed through specific smoking cessation interventions (SCIs) for a lung cancer screening eligible population. This systematic review aims to identify the behavioural elements of SCIs used in older adults from low socioeconomic groups, and to examine their impact on smoking abstinence and psychosocial variables.MethodSystematic searches of Medline, EMBASE, PsychInfo and CINAHL up to November 2018 were conducted. Included studies examined the characteristics of SCIs and their impact on relevant outcomes including smoking abstinence, quit motivation, nicotine dependence, perceived social influence and quit determination. Included studies were restricted to socioeconomically deprived older adults who are at (or approaching) eligibility for lung cancer screening. Narrative data synthesis was conducted.ResultsEleven studies met the inclusion criteria. Methodological quality was variable, with most studies using self-reported smoking cessation and varying length of follow-up. There were limited data to identify the optimal form of behavioural SCI for the target population. Intense multimodal behavioural counselling that uses incentives and peer facilitators, delivered in a community setting and tailored to individual needs indicated a positive impact on smoking outcomes.ConclusionTailored, multimodal behavioural interventions embedded in local communities could potentially support cessation among older, deprived smokers. Further high-quality research is needed to understand the effectiveness of SCIs in the context of lung screening for the target population.PROSPERO registration numberCRD42018088956.
A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics: study protocol for the J-SUPPORT 1901 (ACCESS) study
Authors: Fujiwara Masaki , Inagaki Masatoshi , Shimazu Taichi , Kodama Masafumi , So Ryuhei , Matsushita Takanori , Yoshimura Yusaku , Horii Shigeo , Fujimori Maiko , Takahashi Hirokazu , Nakaya Naoki , Kakeda Kyoko , Miyaji Tempei , Hinotsu Shiro , Harada Keita , Okada Hiroyuki , Uchitomi Yosuke , Yamada Norihito 
Published: November 2019

IntroductionOne of the reasons for the high mortality rate from cancer in people with schizophrenia is delay in diagnosis. Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening. Therefore, we developed a case management (CM) intervention to encourage participation in cancer screening. The purpose of this study was to examine the efficacy of CM to encourage participation in cancer screening for people with schizophrenia, with particular focus on colorectal cancer screening by faecal occult blood testing, compared with usual intervention (UI), namely, municipal public education.Methods and analysisThis is an individually randomised, parallel group trial with blinded outcome assessments. The participants will be randomly allocated to either the CM plus UI group or UI alone group in a 1:1 ratio using a web-based program at a data management centre. The primary end point of the study is participation in colorectal cancer screening in the year of intervention, which will be assessed based on municipal records.Ethics and disseminationThis study is performed in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan’s Ministry of Education, Science, and Technology and the Ministry of Health, Labour, and Welfare and the modified Act on the Protection of Personal Information as well as the Declaration of Helsinki. This study was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital on 23 April 2019 (approval number: RIN1904-003). The findings of this trial will be submitted to an international peer-reviewed journal.Trial registration numberUMIN000036017.