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Impact of a nutritional supplement (Impryl) on male fertility: study protocol of a multicentre, randomised, double-blind, placebo-controlled clinical trial (SUppleMent Male fERtility, SUMMER trial).

Roos Smits, Kathleen D'Hauwers, Joanna IntHout, Didi Braat, Kathrin Fleischer,

INTRODUCTION:Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples, a male factor is involved. Most of the male infertile cases are characterised as 'idiopathic', except for a small percentage of cases which are ... Read more >>

BMJ Open (BMJ open)
[2020, 10(7):e035069]

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Flare-IBD: development and validation of a questionnaire based on patients' messages on an internet forum for early detection of flare in inflammatory bowel disease: study protocol.

Laetitia Ricci, Jonathan Epstein, Anne Buisson, Corinne Devos, Yannick Toussaint, Laurent Peyrin-Biroulet, Francis Guillemin,

INTRODUCTION:Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease (IBD), are chronic disabling conditions characterised by flares followed by periods of remission. However, patients with IBD are seen every 3-6 months in the outpatient clinic, and the occurrence of a flare between two outpatient visits is ... Read more >>

BMJ Open (BMJ open)
[2020, 10(7):e037211]

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Challenges and facilitators of hospice decision-making: a retrospective review of family caregivers of home hospice patients in a rural US-Mexico border region-a qualitative study.

Eunjeong Ko, Dahlia Fuentes, Savitri Singh-Carlson, Frances Nedjat-Haiem,

OBJECTIVES:Hospice care (HC) is seen as a comprehensive approach, that enhances quality of end-of-life (EOL) care, for terminally ill patients. Despite its positive aspects, HC enrolment is disproportionate for rural patients, who are less likely to use HC in comparison to their urban counterparts. The purpose of this study was ... Read more >>

BMJ Open (BMJ open)
[2020, 10(7):e035634]

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Who gets referred for knee or hip replacement? A theoretical model of the potential impact of evidence-based referral thresholds using data from a retrospective review of clinic records from an English musculoskeletal referral hub.

Helen A Dakin, Peter Eibich, Alastair Gray, James Smith, Karen L Barker, David Beard, Andrew J Price, ,

OBJECTIVES:To estimate the relationship between patient characteristics and referral decisions made by musculoskeletal hubs, and to assess the possible impact of an evidence-based referral tool. DESIGN:Retrospective analysis of medical records and decision tree model evaluating policy changes using local and national data. SETTING:One musculoskeletal interface clinic (hub) in England. PARTICIPANTS:922 ... Read more >>

BMJ Open (BMJ open)
[2020, 10(7):e028915]

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Prevalence and predictors of road crash involvement among medical doctors in Malaysia: a cross-sectional study protocol.

Aneesa Abdul Rashid, Navin Kumar Devaraj, Halidah Mohd Yusof, Fauzan Mustapha, Shaw Voon Wong, Ahmad Filza Ismail, Khairil Idham Ismail, Ahmad Munir Qureshi, Rusli Bin Nordin,

INTRODUCTION:Medical doctors are often subjected to long working hours with minimal rest in between the shifts. This has led to many fatal and non-fatal road crash involvement (RCI). This study aims to determine the prevalence and predictors of RCI among medical doctors in Malaysia. METHODS AND ANALYSIS:This is a cross-sectional ... Read more >>

BMJ Open (BMJ open)
[2020, 10(7):e037653]

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Chronic diseases and multimorbidity among unemployed and employed persons in the Netherlands: a register-based cross-sectional study.

Berivan Yildiz, Merel Schuring, Marike G Knoef, Alex Burdorf,

OBJECTIVES:The first objective of this study was to describe the age-specific prevalence of chronic diseases and multimorbidity among unemployed and employed persons. The second objective was to examine associations of employment status and sociodemographic characteristics with chronic diseases and multimorbidity. DESIGN:Data linkage of cross-sectional nationwide registries on employment status, medication ... Read more >>

BMJ Open (BMJ open)
[2020, 10(7):e035037]

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Social capital and peer influence of tobacco consumption: a cross-sectional study among household heads in rural Uttar Pradesh, India.

Md Zabir Hasan, Joanna E Cohen, David Bishai, Caitlin E Kennedy, Krishna D Rao, Akshay Ahuja, Shivam Gupta,

OBJECTIVE:Having the world's second-largest tobacco-consuming population, tobacco control is a priority agenda of the Indian Government. Yet, there is no evidence of how peer influence and nature of social relationships-defined as social capital-affect tobacco use. This study aimed to explore the role of social capital and peer influence on tobacco ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e037202]

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Interpretation of China's 2017 health expenditure: a latent profile analysis of panel data.

Shuang Zang, Meizhen Zhao, Jing OuYang, Xin Wang,

OBJECTIVE:To explore the latent structure of health financing and the institutional distribution of health expenditure (focused on hospital expenditure) in provinces, autonomous regions and municipalities of mainland China, and to examine how these profiles may be related to their externalising and internalising characteristics. STUDY DESIGN:The study used panel data harvested ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e035512]

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Competencies for collaboration between general practitioners and medical specialists: a qualitative study of the patient perspective.

Marijn Janssen, Cornelia R M G Fluit, Margaretha H Sagasser, Loes H J Kusters, Nynke D Scherpbier-de Haan, Jacqueline de Graaf,

OBJECTIVES:To explore the patient view of competencies essential for doctors to provide good collaboration at the primary-secondary care interface. DESIGN:We used a qualitative research approach. Focus groups with patients were conducted to explore their opinions of doctors' competencies to provide good collaboration between primary and secondary care doctors. Transcripts were ... Read more >>

BMJ Open (BMJ open)
[2020, 10(7):e037043]

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International prospective observational study investigating the disease course and heterogeneity of paediatric-onset inflammatory bowel disease: the protocol of the PIBD-SETQuality inception cohort study.

Martine A Aardoom, Polychronis Kemos, Irma Tindemans, Marina Aloi, Sibylle Koletzko, Arie Levine, Dan Turner, Gigi Veereman, Mattias Neyt, Richard K Russell, Thomas D Walters, Frank M Ruemmele, Janneke N Samsom, Nicholas M Croft, Lissy de Ridder, ,

INTRODUCTION:Patients with paediatric-onset inflammatory bowel disease (PIBD) may develop a complicated disease course, including growth failure, bowel resection at young age and treatment-related adverse events, all of which can have significant and lasting effects on the patient's development and quality of life. Unfortunately, we are still not able to fully ... Read more >>

BMJ Open (BMJ open)
[2020, 10(7):e035538]

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Comparison of prevalence and associated factors of depressive disorder between patients with head and neck cancer and those with lung cancer at a tertiary hospital in Taiwan: a cross-sectional study.

Yu Lee, Chi-Fa Hung, Chih-Yen Chien, Pao-Yen Lin, Meng-Chih Lin, Chin-Chou Wang, Hung-I Lu, Yung-Che Chen, Mian-Yoon Chong, Liang-Jen Wang,

OBJECTIVE:Depression is a common comorbidity in cancer patients. This study aimed to compare the prevalence and associated factors of depressive disorder between patients with head and neck cancer (HNC) and those with lung cancer (LC). DESIGN:This study used a cross-sectional design with consecutive sampling. SETTING:A medical centre (Kaohsiung Chang Gung ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e037918]

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Realist evaluation of a theory-based life skills programme aiming to prevent addictive behaviours in adolescents: the ERIEAS study protocol.

Judith Martin-Fernandez, Aurelie Affret, Emma Martel, Romain Gallard, Laurence Merchadou, Laetitia Moinot, Monique Termote, Vincent Dejarnac, François Alla, Linda Cambon,

INTRODUCTION:Adolescence is a sensitive life stage during which tobacco, alcohol and cannabis are used as ways to learn and adopt roles. There is a great deal of interest in substance use (SU) prevention programmes for young people that work to change representations of these products and help with mobilisation of ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e034530]

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Associations between multimorbidity and adverse clinical outcomes in patients with chronic kidney disease: a systematic review and meta-analysis.

Michael K Sullivan, Alastair J Rankin, Bhautesh D Jani, Frances S Mair, Patrick B Mark,

OBJECTIVE:To systematically review the literature exploring the associations between multimorbidity (the presence of two or more long-term conditions (LTCs)) and adverse clinical outcomes in patients with chronic kidney disease (CKD). DESIGN:Systematic review and meta-analysis. DATA SOURCES:MEDLINE, EMBASE, CINAHL, Cochrane Library and SCOPUS (1946-2019). The main search terms were 'Chronic Kidney ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e038401]

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Study protocol for the ACT response pilot intervention: development, implementation and evaluation of a systems-based Agitation Code Team (ACT) in the emergency department.

Ambrose H Wong, Jessica M Ray, Marc A Auerbach, Arjun K Venkatesh, Caitlin McVaney, Danielle Burness, Christopher Chmura, Thomas Saxa, Mark Sevilla, Colin T Flood, Amitkumar Patel, Travis Whitfill, James D Dziura, Kimberly A Yonkers, Andrew Ulrich, Steven L Bernstein,

INTRODUCTION:Emergency department (ED) visits for behavioural conditions are rising, with 1.7 million associated episodes of patient agitation occurring annually in acute care settings. When de-escalation techniques fail during agitation management, patients are subject to use of physical restraints and sedatives, which are associated with up to 37% risk of hypotension, apnoea ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e036982]

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Elastic-band resistance exercise or vibration treatment in combination with hydroxymethylbutyrate (HMB) supplement for management of sarcopenia in older people: a study protocol for a single-blinded randomised controlled trial in Hong Kong.

Simon Kwoon-Ho Chow, Yu-Ning Chim, Keith Yu-Kin Cheng, Chung-Yan Ho, Wing-Tung Ho, Kenneth Chik-Chee Cheng, Ronald Man-Yeung Wong, Wing-Hoi Cheung,

INTRODUCTION:Sarcopenia is a geriatric syndrome characterised by progressive loss of skeletal muscle mass and function with risks of adverse outcomes and becomes more prevalent due to ageing population. Elastic-band exercise, vibration treatment and hydroxymethylbutyrate (HMB) supplementation were previously proven to have positive effects on the control of sarcopenia. The purpose ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e034921]

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Economic evaluation alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (E-PROSPECT): study protocol.

Vincent Issac Lau, Deborah J Cook, Robert Fowler, Bram Rochwerg, Jennie Johnstone, François Lauzier, John C Marshall, John Basmaji, Diane Heels-Ansdell, Lehana Thabane, Feng Xie, ,

INTRODUCTION:Ventilator-associated pneumonia (VAP) is a common healthcare-associated infection in the intensive care unit (ICU). Probiotics are defined as live microorganisms that may confer health benefits when ingested. Prior randomised trials suggest that probiotics may prevent infections such as VAP and Clostridioides difficile-associated diarrhoea (CDAD). PROSPECT (Probiotics to Prevent Severe Pneumonia ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e036047]

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Development of a core outcome set to use in the research and assessment of malignant bowel obstruction: protocol for the RAMBO study.

Elin Baddeley, Alison Bravington, Miriam Johnson, David C Currow, Fliss Em Murtagh, Elaine Boland, George Obita, Annmarie Nelson, Kathy Seddon, Alfred Oliver, Simon Noble, Jason Boland,

INTRODUCTION:Studies regarding the management of malignant bowel obstruction (MBO) report conflicting findings. This is partly due to different outcome measures being used to evaluate severity of MBO and the response to treatments. Furthermore, current outcome measures focus mainly on measurable physiological parameters which may not correlate strongly with patient-defined quality ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e039154]

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Digital epidemiological and citizen science methodology to capture prospective physical activity in free-living conditions: a SMART Platform study.

Tarun Reddy Katapally, Luan Manh Chu,

OBJECTIVES:The purpose of this study was to develop a replicable methodology of mobile ecological momentary assessments (EMAs) to capture prospective physical activity (PA) within free-living social and physical contexts by leveraging citizen-owned smartphones running on both Android and iOS systems. DESIGN:Data were obtained from the cross-sectional pilots of the SMART ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e036787]

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Barriers in care for children with life-threatening conditions: a qualitative interview study in the Netherlands.

Marije Brouwer, Els L M Maeckelberghe, Agnes van der Heide, Irma Hein, Eduard Verhagen,

OBJECTIVE:To identify barriers, as perceived by parents, to good care for children with life-threatening conditions. DESIGN:In a nationwide qualitative study, we held in-depth interviews regarding end-of-life care with parents of children (aged 1 to 12 years) who were living with a life-threatening illness or who had died after a medical ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e035863]

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Patient, physiotherapist and surgeon endorsement of the core domain set for total hip and total knee replacement in Germany: a study protocol for an OMERACT initiative.

Robert Prill, Jasvinder A Singh, Gesine H Seeber, Sabrina Mai Nielsen, Susan Goodman, Sven Michel, Christian Kopkow, Robert Schulz, Peter Choong, Hagen Hommel,

INTRODUCTION:There is a lack of harmonising measures for clinical trials on total joint replacement (TJR) that would allow for results from TJR studies to be compared or pooled. The Outcome Measures in Rheumatology (OMERACT) TJR core domain set is already endorsed among patients and physicians in the USA and Australia. ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e035207]

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The Problem-Solving Decision-Making scale-translation and validation for the Portuguese language: a cross-sectional study.

Micaela Gregório, Andreia Teixeira, Rosália Páscoa, Sofia Baptista, Rosa Carvalho, Carlos Martins,

OBJECTIVES:To translate and validate the Problem-Solving Decision-Making scale instrument into the Portuguese language. DESIGN:Cross-sectional study. SETTING PARTICIPANTS:The Problem-Solving Decision-Making scale was translated from English to Portuguese and then back-translated to obtain a final version. The questionnaire was then applied face-to-face from January to March 2019 in a representative sample of ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e033625]

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Randomised, double-blinded, placebo-controlled trial to investigate the role of laparoscopic transversus abdominis plane block in gastric bypass surgery: a study protocol.

Amer Jarrar, Adele Budiansky, Naveen Eipe, Caolan Walsh, Nicole Kolozsvari, Amy Neville, Joseph Mamazza,

INTRODUCTION:Evaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery. METHODS:150 patients Living with obesity undergoing elective laparoscopic Roux-En-Y gastric bypass for obesity will be recruited to this double-blinded, ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e025818]

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Evaluation of the General Practice Pharmacist (GPP) intervention to optimise prescribing in Irish primary care: a non-randomised pilot study.

Karen Cardwell, Susan M Smith, Barbara Clyne, Laura McCullagh, Emma Wallace, Ciara Kirke, Tom Fahey, Frank Moriarty, ,

OBJECTIVE:Limited evidence suggests integration of pharmacists into the general practice team could improve medicines management for patients, particularly those with multimorbidity and polypharmacy. This study aimed to develop and assess the feasibility of an intervention involving pharmacists, working within general practices, to optimise prescribing in Ireland. DESIGN:Non-randomised pilot study. SETTING:Primary ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e035087]

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Study protocol: building an evidence base for epidemiology emergency response, a mixed-methods study.

Amy Elizabeth Parry, Martyn D Kirk, David N Durrheim, Babatunde Olowokure, Tambri Housen,

INTRODUCTION:Determinants and drivers for emergencies, such as political instability, weak health systems, climate change and forcibly displaced populations, are increasing the severity, complexity and frequency of public health emergencies. As emergencies become more complex, it is increasingly important that the required skillset of the emergency response workforce is clearly defined. ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e037326]

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Effects of adding adjunctive hyperbaric oxygen therapy to standard wound care for diabetic foot ulcers: a protocol for a systematic review with meta-analysis and trial sequential analysis.

Julie Vinkel, Niels Frederich Rose Holm, Janus C Jakobsen, Ole Hyldegaard,

INTRODUCTION:Diabetic foot ulcer represents a major health problem globally. Preliminary studies have indicated that systemic treatment of diabetic foot ulcer patients with hyperbaric oxygen therapy have beneficial effects on wound healing, risk of amputation, glycaemic control, atherosclerosis, inflammatory markers and other clinical and laboratory parameters. This protocol for a systematic ... Read more >>

BMJ Open (BMJ open)
[2020, 10(6):e031708]

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