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https://www.readbyqxmd.com/read/28918414/a-protocol-of-a-cross-sectional-study-evaluating-an-online-tool-for-early-career-peer-reviewers-assessing-reports-of-randomised-controlled-trials
#1
Anthony Chauvin, David Moher, Doug Altman, David L Schriger, Sabina Alam, Sally Hopewell, Daniel R Shanahan, Alessandro Recchioni, Philippe Ravaud, Isabelle Boutron
INTRODUCTION: Systematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to compare the accuracy of early career peer reviewers who use an innovative online tool to the usual peer reviewer process in evaluating the completeness of reporting and switched primary outcomes in completed reports. METHODS AND ANALYSIS: This is a cross-sectional study of individual two-arm parallel-group randomised controlled trials (RCTs) published in the BioMed Central series medical journals, BMJ, BMJ Open and Annals of Emergency Medicine and indexed with the publication type 'Randomised Controlled Trial'...
September 15, 2017: BMJ Open
https://www.readbyqxmd.com/read/28918408/effectiveness-cost-utility-and-implementation-of-a-decision-aid-for-patients-with-localised-prostate-cancer-and-their-partners-study-protocol-of-a-stepped-wedge-cluster-randomised-controlled-trial
#2
Hoda H M Al-Itejawi, Cornelia F van Uden-Kraan, Peter M van de Ven, Veerle M H Coupé, André N Vis, Jakko A Nieuwenhuijzen, Jeroen A van Moorselaar, Irma M Verdonck-de Leeuw
INTRODUCTION: Patient decision aids (PDAs) have been developed to help patients make an informed choice for a treatment option. Despite proven benefits, structural implementation falls short of expectations. The present study aims to assess the effectiveness and cost-utility of the PDA among newly diagnosed patients with localised prostate cancer and their partners, alongside implementation of the PDA in routine care. METHODS/ANALYSIS: A stepped-wedge cluster randomised trial will be conducted...
September 15, 2017: BMJ Open
https://www.readbyqxmd.com/read/28914335/regulatory-experience-of-tops-an-internet-based-system-to-prevent-healthy-subjects-from-over-volunteering-for-uk-clinical-trials
#3
C Allen, G Francis, J Martin, M Boyce
PURPOSE: The aim was to review the use of The Over-volunteering Prevention System (TOPS) since the HRA began hosting it in 2013, and the Medicines and Healthcare products Regulatory Agency (MHRA) experience of monitoring its use by UK clinical research units. METHODS: The HRA searched the TOPS database for the number, type and location of units and the number of entries. The MHRA inspectors reviewed their findings from routine inspections. RESULTS: Twenty-two additional UK units registered to use TOPS during 2013-2016, making a total of 84 units since TOPS was established in 2002...
September 15, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28914115/knowledge-attitudes-and-perspective-on-adverse-drug-reaction-reporting-in-a-public-sector-hospital-in-south-africa-baseline-analysis
#4
Antionette Terblanche, Johanna Catharina Meyer, Brian Godman, Robert Stanley Summers
BACKGROUND AND AIMS: Adverse drug reactions (ADRs) can cause significant harm in patients; however, ADRs are under-reported in many countries, including South Africa, where evidence of a pharmacovigilance (PV) system to monitor and manage ADRs is a requirement for compliance with norms and standards for quality healthcare delivery. We conducted an analysis amongst health care professionals (HCPs) at Sebokeng Hospital to assess the situation there. METHODS: Data were collected using a structured self-administered questionnaire, targeting all medical practitioners, nurses, pharmacists and pharmacist assistants in the hospital...
September 15, 2017: Hospital Practice (Minneapolis)
https://www.readbyqxmd.com/read/28913483/the-prevalence-of-perioperative-complications-in-patients-with-and-without-obstructive-sleep-apnoea-a-prospective-cohort-study
#5
Tatiana Ambrosii, Serghei Şandru, Adrian Belîi
BACKGROUND AND AIMS: Patients with obstructive sleep apnoea (OSA) have a high risk of postoperative complications. The purpose of the study was to record the spectrum and frequency of postoperative complications in patients with OSA versus (vs.) without OSA depending on the type of surgery and type of anaesthesia in a large cohort of patients. METHODS: We conducted a prospective, descriptive study (n = 400). Ethics Committee approval was obtained and written informed consent was signed...
October 2016: Rom J Anaesth Intensive Care
https://www.readbyqxmd.com/read/28913174/research-ethics-committees-in-the-pacific-islands-gaps-and-opportunities-for-health-sector-strengthening
#6
J T Denholm, K Bissell, K Viney, A M Durand, H L Cash, C Roseveare, O E Merilles, A D Harries, S Biribo
There has been a range of developments in recent years to stimulate increasing public health research activity throughout the Pacific. Development of local capacity for ethics committee review and oversight is, however, frequently underdeveloped. This is reflected in the number of Pacific Island nations where ethics committees have not been established or where only informal processes exist for ethics review and oversight. This is problematic for the optimal development of relevant and culturally appropriate research, and building up local ethics committees should be part of continued research development in the Pacific...
March 21, 2017: Public Health Action
https://www.readbyqxmd.com/read/28912193/effectiveness-of-a-multifactorial-intervention-based-on-an-application-for-smartphones-heart-healthy-walks-and-a-nutritional-workshop-in-patients-with-type-2-diabetes-mellitus-in-primary-care-emid-study-protocol-for-a-randomised-controlled-trial
#7
Rosario Alonso-Domínguez, Manuel A Gómez-Marcos, Maria C Patino-Alonso, Natalia Sánchez-Aguadero, Cristina Agudo-Conde, Carmen Castaño-Sánchez, Luis García-Ortiz, José I Recio-Rodríguez
INTRODUCTION: New information and communication technologies (ICTs) may promote lifestyle changes, but no adequate evidence is available on their combined effect of ICTs with multifactorial interventions aimed at improving diet and increasing physical activity in patients with type 2 diabetes mellitus (DM2). The primary objective of this study is to assess the effect of a multifactorial intervention to increase physical activity and adherence to Mediterranean diet in DM2. METHODS AND ANALYSIS: Study scope and population: The study will be conducted at 'La Alamedilla' primary care research unit in Salamanca (Spain)...
September 14, 2017: BMJ Open
https://www.readbyqxmd.com/read/28912192/mechanical-cervical-ripening-for-women-with-prolongedpregnancies-magpop-protocol-for-a-randomised-controlled-trial-of-a-silicone-double-balloon-catheter-versus-the-propess-system-for-the-slow-release-of-dinoprostone-for-cervical-ripening-of-prolonged-pregnancies
#8
Caroline Diguisto, Amélie Le Gouge, Bruno Giraudeau, Franck Perrotin
INTRODUCTION: Induction of labour for prolonged pregnancies (PP) when the cervix is unfavourable is a challenging situation. Cervical ripening by pharmacological or mechanical techniques before oxytocin administration is used to increase the likelihood of vaginal delivery. Both techniques are equally effective in achieving vaginal delivery but excessive uterine activity, which induces fetal heart rate (FHR) anomalies, is more frequent after the pharmacological intervention. We hypothesised that mechanical cervical ripening could reduce the caesarean rate for non-reassuring FHR especially in PP where fetuses are already susceptible to this...
September 14, 2017: BMJ Open
https://www.readbyqxmd.com/read/28912191/high-versus-low-energy-administration-in-the-early-phase-of-acute-pancreatitis-goulash-trial-protocol-of-a-multicentre-randomised-double-blind-clinical-trial
#9
Katalin Márta, Anikó N Szabó, Dániel Pécsi, Péter Varjú, Judit Bajor, Szilárd Gódi, Patrícia Sarlós, Alexandra Mikó, Kata Szemes, Mária Papp, Tamás Tornai, Áron Vincze, Zsolt Márton, Patrícia A Vincze, Erzsébet Lankó, Andrea Szentesi, Tímea Molnár, Roland Hágendorn, Nándor Faluhelyi, István Battyáni, Dezső Kelemen, Róbert Papp, Attila Miseta, Zsófia Verzár, Markus M Lerch, John P Neoptolemos, Miklós Sahin-Tóth, Ole H Petersen, Péter Hegyi
INTRODUCTION: Acute pancreatitis (AP) is an inflammatory disease with no specific treatment. Mitochondrial injury followed by ATP depletion in both acinar and ductal cells is a recently discovered early event in its pathogenesis. Importantly, preclinical research has shown that intracellular ATP delivery restores the physiological function of the cells and protects from cell injury, suggesting that restoration of energy levels in the pancreas is therapeutically beneficial. Despite several high quality experimental observations in this area, no randomised trials have been conducted to date to address the requirements for energy intake in the early phase of AP...
September 14, 2017: BMJ Open
https://www.readbyqxmd.com/read/28910353/reference-equations-for-the-six-minute-walk-distance-in-the-healthy-chinese-population-aged-18-59-years
#10
He Zou, Xiuruo Zhu, Jia Zhang, Yi Wang, Xiaozhen Wu, Fang Liu, Xiaofeng Xie, Xiaoshu Chen
BACKGROUND: The six-minute walk test (6MWT) is a safe, simple, inexpensive tool for evaluating the functional exercise capacity of patients with chronic respiratory disease. However, there is a lack of standard reference equations for the six-minute walk distance (6MWD) in the healthy Chinese population aged 18-59 years. AIMS: The purposes of the present study were as follows: 1) to measure the anthropometric data and walking distance of a sample of healthy Chinese Han people aged 18-59 years; 2) to construct reference equations for the 6MWD; 3) to compare the measured 6MWD with previously published equations...
2017: PloS One
https://www.readbyqxmd.com/read/28904010/vitamin-d-supplementation-to-palliative-cancer-patients-protocol-of-a-double-blind-randomised-controlled-trial-palliative-d
#11
Maria Helde-Frankling, Jenny Bergqvist, Caritha Klasson, Marie Nordström, Jonas Höijer, Peter Bergman, Linda Björkhem-Bergman
BACKGROUND: According to a small pilot study on palliative cancer patients at our ward, vitamin D supplementation had beneficial effects on pain (measured as opioid consumption), infections and quality of life (QoL) without having any significant side effects. OBJECTIVE: The primary objective of the 'Palliative-D' study is to test the hypothesis that vitamin D supplementation for 12 weeks reduces opioid consumption. The secondary objectives are to study if reduction of antibiotic consumption and fatigue as well as improvement in QoL assessments can be observed...
September 13, 2017: BMJ Supportive & Palliative Care
https://www.readbyqxmd.com/read/28901239/ethical-issues-in-action-oriented-research-in-indonesia
#12
Rini Rachmawaty
BACKGROUND: Action-oriented research is one of the most frequent research types implemented to transform community health in Indonesia. Three researchers and 11 graduate students from a developed country in East Asia conducted a fieldwork program in a remote area in South Sulawesi Province. Although the project was completed, whether or not the international standards for human subject research were applied into that study remains unclear. OBJECTIVES: This study aimed to examine ethical issues raised from that case, analyze constraints to the problems, and recommend alternatives to protect vulnerable populations from being exploited by local/international researchers...
September 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28901204/experiences-behaviors-and-perceptions-of-registered-nurses-regarding-research-ethics-and-misconduct
#13
Oren Asman, Semyon Melnikov, Sivia Barnoy, Nili Tabak
BACKGROUND: Nurses engaging in research are held to research ethics standards. Research aim: Examine experiences, behaviors, and perceptions of nurses in Israel regarding research ethics and explore possible related factors. RESEARCH DESIGN: An original investigator-designed self-administered questionnaire measured five variables: (a) ethics in research, (b) encountered research misconduct during the course of one's studies, (c) the inclination to fabricate data, (d) the inclination to select or omit data, and (e) knowledge of research misconduct in the workplace...
January 1, 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28900674/who-is-willing-to-participate-in-low-risk-pragmatic-clinical-trials-without-consent
#14
Rafael Dal-Ré, Antonio J Carcas, Xavier Carné
PURPOSE: General notification offers a possible alternative to written informed consent for pragmatic randomized controlled trials (pRCTs). It involves patients being informed through brochures, posters, and letters that research is being conducted simultaneously to providing clinical care and that patients will be enrolled in pRCTs without study-specific consent. A previous survey found that a substantial minority of respondents endorsed general notification. We aimed to know who is willing to enroll in this type of trials using general notification rather than written consent...
September 12, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28900543/switching-to-aflibercept-in-diabetic-macular-edema-not-responding-to-ranibizumab-and-or-intravitreal-dexamethasone-implant
#15
Antoine Herbaut, Franck Fajnkuchen, Lise Qu-Knafo, Sylvia Nghiem-Buffet, Bahram Bodaghi, Audrey Giocanti-Auregan
PURPOSE: To assess short-term functional and anatomical outcomes of refractory diabetic macular edema (DME) following a switch from ranibizumab or dexamethasone to aflibercept. METHODS: We included retrospectively eyes with persistent DME after at least 3 ranibizumab and/or one dexamethasone implant intravitreal injections (IVI). The primary endpoint was the mean change in visual acuity (VA) at month 6 (M6) after switching. RESULTS: Twenty-five eyes were included...
2017: Journal of Ophthalmology
https://www.readbyqxmd.com/read/28899891/effect-of-anesthesia-depth-on-postoperative-clinical-outcome-in-patients-with-supratentorial-tumor-depth-study-protocol-for-a-randomized-controlled-trial
#16
Qianyu Cui, Yuming Peng, Xiaoyuan Liu, Bo Jia, Jia Dong, Ruquan Han
INTRODUCTION: Recent studies have shown that deep anaesthesia is associated with poor outcomes. However, no randomised controlled trials have been conducted to test the causality in patients undergoing brain tumour resection. METHODS AND ANALYSIS: DEPTH is a multicenter, randomised, parallel-group, blind trial. The depth of general anaesthesia will be monitored using the bispectral index (BIS). Patients elected for supratentorial tumour resection will be randomly allocated to the deep or the light anaesthesia group in which the target BIS value is 35 or 50, respectively...
September 11, 2017: BMJ Open
https://www.readbyqxmd.com/read/28899390/-if-it-s-a-medical-issue-i-would-have-covered-it-by-now-learning-about-fibromyalgia-through-the-hidden-curriculum-a-qualitative-study
#17
V Silverwood, C A Chew-Graham, I Raybould, B Thomas, S Peters
BACKGROUND: Fibromyalgia syndrome (FMS) is a long-term condition that affects between 1 and 5% of the general population and lies within the spectrum of medically unexplained symptoms (MUS). FMS can be difficult to diagnose and is usually done so as a diagnosis of exclusion. There is continuing debate regarding its legitimacy excluding other causes of symptoms. It is known that the diagnosis and management of MUS, including FMS, receives little attention in medical curricula and attitudes towards patients with FMS amongst medical professionals and trainees can be negative...
September 12, 2017: BMC Medical Education
https://www.readbyqxmd.com/read/28898315/-morbimortality-associated-to-nutritional-status-and-feeding-path-in-children-with-cerebral-palsy
#18
M J Figueroa, C Rojas, S Barja
INTRODUCTION: Children and adolescents with cerebral palsy (CP) have a high prevalence of malnutrition associated to poor prognosis. For an adequate nutritional assessment, new growth curves (Brooks, 2011) are available, in which precise cut-off points in Weight/Age index correlate to increased morbidity and mortality rate. OBJECTIVE: To evaluate risk of hospitalization and death in patients with CP, according to nutritional risk (NR). PATIENTS AND METHOD: Observational and prospective cohort study of patients with CP in an outpatient referral center...
2017: Revista Chilena de Pediatría
https://www.readbyqxmd.com/read/28895981/radiofrequency-thermocoagulation-for-the-treatment-of-lower-extremity-ischemic-pain-comparison-of-monopolar-and-bipolar-modes
#19
Dilek Destegül, Geylan Işık, Hayri Özbek, Hakkı Ünlügenç, Murat Ilgınel
OBJECTIVES: Radiofrequency thermocoagulation (RFT) has been reported to be used safely to treat ischemic lower extremity pain. The objective of the present study was to evaluate efficiency of RFT for treatment of lower extremity ischemic pain and to compare effectiveness of monopolar RFT and bipolar RFT modes. METHODS: Following ethics committee approval, 30 American Society of Anesthesiologists classification I-III patients with ischemic lower extremity pain aged between 18 and 65 years were recruited...
April 2017: Aǧrı: Ağrı (Algoloji) Derneği'nin Yayın Organıdır, the Journal of the Turkish Society of Algology
https://www.readbyqxmd.com/read/28893757/effectiveness-and-cost-effectiveness-of-duloxetine-added-to-usual-care-for-patients-with-chronic-pain-due-to-hip-or-knee-osteoarthritis-protocol-of-a-pragmatic-open-label-cluster-randomised-trial-the-duo-trial
#20
Jacoline J van den Driest, Dieuwke Schiphof, Pim A J Luijsterburg, Aafke R Koffeman, Marc A Koopmanschap, Patrick J E Bindels, Sita M A Bierma-Zeinstra
INTRODUCTION: Osteoarthritis (OA) is a highly prevalent painful condition of the musculoskeletal system. The effectiveness of current analgesic options has proven to be limited and improved analgesic treatment is needed. Several randomised placebo-controlled trials have now demonstrated the efficacy of duloxetine, an antidepressant with a centrally acting effect, in the treatment of OA pain. The aim of the current study is to investigate if duloxetine is effective and cost-effective as a third-choice analgesic added to usual care for treating chronic pain compared with usual care alone in general practice...
September 11, 2017: BMJ Open
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