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https://www.readbyqxmd.com/read/28110382/economic-evaluations-alongside-efficient-study-designs-using-large-observational-datasets-the-pleasant-trial-case-study
#1
Matthew Franklin, Sarah Davis, Michelle Horspool, Wei Sun Kua, Steven Julious
BACKGROUND: Large observational datasets such as Clinical Practice Research Datalink (CPRD) provide opportunities to conduct clinical studies and economic evaluations with efficient designs. OBJECTIVES: Our objectives were to report the economic evaluation methodology for a cluster randomised controlled trial (RCT) of a UK NHS-delivered public health intervention for children with asthma that was evaluated using CPRD and describe the impact of this methodology on results...
January 21, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28109247/effectiveness-and-cost-effectiveness-of-a-guided-internet-and-mobile-based-intervention-for-the-indicated-prevention-of-major-depression-in-patients-with-chronic-back-pain-study-protocol-of-the-prod-bp-multicenter-pragmatic-rct
#2
L Sander, S Paganini, J Lin, S Schlicker, D D Ebert, C Buntrock, H Baumeister
BACKGROUND: Reducing the disease burden of major depressive disorder (MDD) is of major public health relevance. The prevention of depression is regarded as one possible approach to reach this goal. People with multiple risk factors for MDD such as chronic back pain and subthreshold depressive symptoms may benefit most from preventive measures. The Internet as intervention setting allows for scaling up preventive interventions on a public mental health level. METHODS: This study is a multicenter pragmatic randomized controlled trial (RCT) of parallel design aiming to investigate the (cost-) effectiveness of an Internet- and mobile-based intervention (IMI) for the prevention of depression in chronic back pain patients (PROD-BP) with subthreshold depressive symptoms...
January 21, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28107729/recombinant-lh-supplementation-in-patients-with-a-relative-reduction-in-lh-levels-during-ivf-icsi-cycles-a-prospective-randomized-controlled-trial
#3
Robert Lahoud, John Ryan, Peter Illingworth, Frank Quinn, Michael Costello
PURPOSE: The aim of this study was to assess the use of recombinant luteinizing hormone (rLH) supplementation in patients who experience a reduction in LH concentration during controlled ovarian hyperstimulation (COH) for IVF/ICSI. METHODS: A multi-center prospective randomized controlled trial (RCT) was performed over three years. Two hundred and forty patients aged between 24 and 42 years undergoing IVF/ICSI treatment with a long down regulation (LDR) protocol were recruited...
January 9, 2017: European Journal of Obstetrics, Gynecology, and Reproductive Biology
https://www.readbyqxmd.com/read/28104998/clinical-assessments-and-care-interventions-to-promote-oral-hydration-amongst-older-patients-a-narrative-systematic-review
#4
Lloyd L Oates, Christopher I Price
BACKGROUND: Older patients in hospital may be unable to maintain hydration by drinking, leading to intravenous fluid replacement, complications and a longer length of stay. We undertook a systematic review to describe clinical assessment tools which identify patients at risk of insufficient oral fluid intake and the impact of simple interventions to promote drinking, in hospital and care home settings. METHOD: MEDLINE, CINAHL, and EMBASE databases and two internet search engines (Google and Google Scholar) were examined...
2017: BMC Nursing
https://www.readbyqxmd.com/read/28103841/a-two-site-two-arm-34-week-double-blind-parallel-group-randomized-controlled-trial-of-reduced-nicotine-cigarettes-in-smokers-with-mood-and-or-anxiety-disorders-trial-design-and-protocol
#5
Sophia I Allen, Jonathan Foulds, Gladys N Pachas, Susan Veldheer, Corinne Cather, Nour Azzouz, Shari Hrabovsky, Ahmad Hameed, Jessica Yingst, Erin Hammett, Jennifer Modesto, Nicolle M Krebs, Junjia Zhu, Jason Liao, Joshua E Muscat, John Richie, A Eden Evins
BACKGROUND: The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks...
January 19, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28103811/study-protocol-effect-of-playful-training-on-functional-abilities-of-older-adults-a-randomized-controlled-trial
#6
Jari Due Jessen, Henrik Hautop Lund
BACKGROUND: Loss of functional capabilities due to inactivity is one of the most common reasons for fall accidents, and it has been well established that loss of capabilities can be effectively reduced by physical activity. Pilot studies indicate a possible improvement in functional abilities of community dwelling elderly as a result of short-term playing with an exergame system in the form of interactive modular tiles. Such playful training may be motivational to perform and viewed by the subjects to offer life-fulfilling quality, while providing improvement in physical abilities, e...
January 19, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28095850/building-system-capacity-for-the-integration-of-mental-health-at-the-level-of-primary-care-in-tunisia-a-study-protocol-in-global-mental-health
#7
Jessica Spagnolo, François Champagne, Nicole Leduc, Myra Piat, Wahid Melki, Fatma Charfi, Marc Laporta
BACKGROUND: In low- and middle-income countries (LMICs), addressing the high prevalence of mental disorders is a challenge given the limited number and unequal distribution of specialists, as well as scarce resources allocated to mental health. The Mental Health Gap Action Programme (mhGAP) and its accompanying Intervention Guide (IG), developed by the World Health Organization (WHO), aim to address this challenge by training non-specialists such as general practitioners (GPs) in mental health care...
January 17, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28089311/sustaining-program-effectiveness-after-implementation-the-case-of-the-self-management-of-well-being-group-intervention-for-older-adults
#8
Martine M Goedendorp, Daphne Kuiper, Sijmen A Reijneveld, Robbert Sanderman, Nardi Steverink
OBJECTIVE: The Self-Management of Well-being (SMW) group intervention for older women was implemented in health and social care. Our aim was to assess whether effects of the SMW intervention were comparable with the original randomized controlled trial (RCT). Furthermore, we investigated threats to effectiveness, such as participant adherence, group reached, and program fidelity. METHODS: In the implementation study (IMP) 287 and RCT 142 women participated. We compared scores on self-management ability and well-being of the IMP and RCT...
January 10, 2017: Patient Education and Counseling
https://www.readbyqxmd.com/read/28086921/a-randomized-controlled-trial-focusing-on-socio-economic-status-for-promoting-vegetable-intake-among-adults-using-a-web-based-nutrition-intervention-programme-study-protocol
#9
Saki Nakamura, Takayo Inayama, Takashi Arao
BACKGROUND: Web-based nutritional education programmes appear to be comparable to those delivered face-to-face. However, no existing web-based nutrition education or similar programme has yet been evaluated with consideration of socio-economic status. The objective of a nutritional education programme of promoting vegetable intake designed a randomized controlled trial (RCT) is to evaluate the results of intervention and to determine how socio-economic status influences the programme effects...
January 13, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28086857/evaluating-a-multicomponent-social-behaviour-change-communication-strategy-to-reduce-intimate-partner-violence-among-married-couples-study-protocol-for-a-cluster-randomized-trial-in-nepal
#10
Cari Jo Clark, Rachael A Spencer, Binita Shrestha, Gemma Ferguson, J Michael Oakes, Jhumka Gupta
BACKGROUND: Intimate partner violence (IPV) is a significant public health issue that affects 1 in 3 women globally and a similarly large number of women in Nepal. Over the past decade, important policy and programmatic steps have been taken to address violence against women in Nepal. There remains a dearth of evidence on the effectiveness of primary violence prevention strategies. The Change Starts at Home study begins to fill this gap by utilizing a multi-component social behaviour change communication (SBCC) strategy involving a radio drama and community mobilization to shift attitudes, norms and behaviours that underpin IPV perpetration in Nepal...
January 13, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28078669/maintenance-phase-in-puva-phototherapy-of-early-stage-mycosis-fungoides-a-critically-appraised-topic
#11
REVIEW
V Grandi, C Delfino, A Pileri, N Pimpinelli
A 65-years-old patient affected by mycosis fungoides stage IB achieved complete remission after a cycle of PUVA phototherapy. As suggested by USCLC guidelines(1) , the patient should be kept in maintenance phase, defined as "period of gradual decrease of frequency of UVL while in clinical remission before discontinuation of phototherapy" by slowly tapering the number of PUVA applications over time up to clinical relapse. USCLC also suggest a standardized schedule for maintenance phase (table 1). Alternatively, the patient could end PUVA therapy and go straight to follow up...
January 12, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28062389/internet-based-hiv-prevention-with-at-home-sexually-transmitted-infection-testing-for-young-men-having-sex-with-men-study-protocol-of-a-randomized-controlled-trial-of-keep-it-up-2-0
#12
Brian Mustanski, Krystal Madkins, George J Greene, Jeffrey T Parsons, Brent A Johnson, Patrick Sullivan, Michael Bass, Rebekah Abel
BACKGROUND: Human immunodeficiency virus (HIV) infections are increasing among young men who have sex with men (YMSM), yet few HIV prevention programs have studied this population. Keep It Up! (KIU!), an online HIV prevention program tailored to diverse YMSM, was developed to fill this gap. The KIU! 2.0 randomized controlled trial (RCT) was launched to establish intervention efficacy. OBJECTIVE: The objective of the KIU! study is to advance scientific knowledge of technology-based behavioral HIV prevention, as well as improve public health by establishing the efficacy of an innovative electronic health (eHealth) prevention program for ethnically and racially diverse YMSM...
January 7, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28061753/treatment-efficacy-of-azithromycin-1%C3%A2-g-single-dose-versus-doxycycline-100%C3%A2-mg-twice-daily-for-7%C3%A2-days-for-the-treatment-of-rectal-chlamydia-among-men-who-have-sex-with-men-a-double-blind-randomised-controlled-trial-protocol
#13
Andrew Lau, Fabian Kong, Christopher K Fairley, Basil Donovan, Marcus Chen, Catriona Bradshaw, Mark Boyd, Janaki Amin, Peter Timms, Sepehr Tabrizi, David G Regan, David A Lewis, Anna McNulty, Jane S Hocking
BACKGROUND: Rectal infection with Chlamydia trachomatis is one of the most common bacterial sexually transmissible infections among men who have sex with men (MSM) with diagnosis rates continuing to rise. Current treatment guidelines recommend either azithromycin 1 g single dose or doxycycline 100 mg twice daily for 7 days. However, there are increasing concerns about treatment failure with azithromycin. We are conducting the first randomised controlled trial (RCT) to compare treatment efficacy of azithromycin versus doxycycline for the treatment of rectal chlamydia in MSM...
January 6, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28056906/the-norwegian-healthy-life-study-protocol-for-a-pragmatic-rct-with-longitudinal-follow-up-on-physical-activity-and-diet-for-adults
#14
Eirik Abildsnes, Eivind Meland, Thomas Mildestvedt, Tonje H Stea, Sveinung Berntsen, Gro Beate Samdal
BACKGROUND: The Norwegian Directorate of Health recommends that Healthy Life Centres (HLCs) be established in primary health care to support behaviour change and reduce the risk of non-communicable diseases. The aim of the present study protocol is to present the rationale, design and methods of a combined pragmatic randomized controlled trial (RCT) and longitudinal cohort study of the effects of attending HLCs concerning physical activity, sedentary behaviour and diet and to explore how psychological well-being and motivational factors may mediate short- and long-term effects...
January 5, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28048897/su-f-j-156-the-feasibility-of-mr-only-imrt-planning-for-prostate-anatomy
#15
R Vaitheeswaran, K R Sivaramakrishnan, Prashant Kumar, Raja Gattamaneni, Girish Kumar
PURPOSE: For prostate anatomy, previous investigations have shown that simulated CT (sCT) generated from MR images can be used for accurate dose computation. In this study, we demonstrate the feasibility of MR-only IMRT planning for prostate case. METHODS: Regular CT (rCT) and MR images of the same patient were acquired for prostate anatomy. Regions-of-interest (ROIs) i.e. target and risk structures are delineated on the rCT. A simulated CT (sCT) is generated from the MR image using the method described by Schadewaldt N et al...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28028674/the-effect-of-verbal-and-video-feedback-on-learning-direct-laryngoscopy-among-novice-laryngoscopists-a-randomized-pilot-study
#16
Jennifer E Sainsbury, Branislav Telgarsky, Matteo Parotto, Ahtsham Niazi, David T Wong, Richard M Cooper
PURPOSE: Skill acquisition in direct laryngoscopy (DL) and tracheal intubation is complex. This pilot study aims to assess feasibility and determine sample size for a subsequent trial comparing DL instruction using a Macintosh-style video laryngoscope (MacVL), with and without video recordings, with conventional DL instruction. METHODS: Medical students with no prior laryngoscopy experience were recruited during their two-week anesthesia rotation. During the first (TRAINING) week, students were randomized into three groups: Control (Macintosh direct laryngoscope), VL-1 (MacVL with real-time feedback), and VL-2 (MacVL with real-time feedback plus video recordings of laryngoscopies)...
December 27, 2016: Canadian Journal of Anaesthesia, Journal Canadien D'anesthésie
https://www.readbyqxmd.com/read/28028319/an-educational-intervention-to-promote-healthy-lifestyles-in-preschool-children-a-cluster-rct
#17
M Iaia, M Pasini, A Burnazzi, P Vitali, E Allara, M Farneti
OBJECTIVE: Promoting 4 healthy behaviours among preschool children: ⩾4 servings of fruit and vegetables/day, ⩾2 h/day of active play, ⩽1 hour/day of TV-watching and 0 sugar sweetened beverages/day. METHODS: We conducted a c-RCT on 425 three-year-old children at 16 childcare centres based in Cesena, Italy. We randomly allocated 8 childcare centres (199 children) to the intervention group and 8 childcare centres (226 children) to the control group. All the randomized childcare centres completed our study protocol...
December 28, 2016: International Journal of Obesity: Journal of the International Association for the Study of Obesity
https://www.readbyqxmd.com/read/28025928/effectiveness-of-the-dader-method-for-pharmaceutical-care-on-patients-with-bipolar-i-disorder-results-from-the-emdader-tab-study
#18
Andrea Salazar-Ospina, Pedro Amariles, Jaime A Hincapié-García, Sebastián González-Avendaño, Dora M Benjumea, Maria José Faus, Luis F Rodriguez
BACKGROUND: Bipolar I disorder (BD-I) is a chronic illness characterized by relapses alternating with periods of remission. Pharmacists can contribute to improved health outcomes in these patients through pharmaceutical care in association with a multidisciplinary health team; however, more evidence derived from randomized controlled trials (RCTs) is needed to demonstrate the effect of pharmaceutical care on patients with BD-I. OBJECTIVE: To assess the effectiveness of a pharmaceutical intervention using the Dader Method on patients with BD-I, measured by the decrease in the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits from baseline through 1 year of follow-up...
January 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28024477/-a-retrospective-study-of-ph-negative-adolescent-and-young-adults-with-acute-b-lymphoblastic-leukemia-in-two-centers
#19
Hong-Hao Gao, Yu Jing, Ming-Juan Liu, Hong-Hua Li, Wen-Rong Huang, Chun-Ji Gao, Dai-Hong Liu, Yong-Hui Li, Sai Huang, Yan Li, Jing Liu, Yong-Qing Zhang, Li Yu
OBJECTIVE: To analyze the therapeutic efficacy of different consolidation therapies after induction remission on Ph negative adolescent and young adults with acute B lymphoblastic leukemia, and to explore the effect of different risk factors on prognosis. METHODS: The treatment and efficacy of 80 Ph negative B-ALL in patients of 16-39 years old in the Hematology Department of 301(65 cases) and 309(15 cases) hospital from 1999 to 2016 are retrospectively analyzed...
December 2016: Zhongguo Shi Yan Xue Ye Xue za Zhi
https://www.readbyqxmd.com/read/28003302/cost-effectiveness-of-early-surgery-versus-conservative-treatment-with-optional-delayed-meniscectomy-for-patients-over-45%C3%A2-years-with-non-obstructive-meniscal-tears-escape-study-protocol-of-a-randomised-controlled-trial
#20
Victor A van de Graaf, Vanessa A B Scholtes, Nienke Wolterbeek, Julia C A Noorduyn, Camille Neeter, Maurits W van Tulder, Daniël B F Saris, Arthur de Gast, Rudolf W Poolman
INTRODUCTION: Recent studies show similar outcome between surgery and conservative treatment in patients with non-obstructive meniscal tears. However, surgery is still often preferred over conservative treatment. When conservative treatment is non-inferior to surgery, shifting the current standard treatment choice to conservative treatment alone could save over €30 millions of direct medical costs on an annual basis. Economic evaluation studies comparing surgery to conservative treatment are lacking...
December 21, 2016: BMJ Open
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