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https://www.readbyqxmd.com/read/28090729/notes-on-the-use-of-randomised-controlled-trials-to-evaluate-complex-interventions-community-treatment-orders-as-an-illustrative-case
#1
Feras Ali Mustafa
Over the past seven decades, randomised controlled trials (RCTs) have revolutionised clinical research and achieved a gold standard status. However, extending their use to evaluate complex interventions is problematic. In this paper we will demonstrate that complex intervention RCTs violate the necessary premises that govern the RCTs logic and underpin their rigour. The lack of blinding, heterogeneity of participants, as well as poor treatment standardisation and difficulty of controlling for confounders, which characterise complex intervention RCTs, can potentially be profoundly detrimental to their integrity...
January 16, 2017: Journal of Evaluation in Clinical Practice
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
#2
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/28089169/the-role-of-n-3-polyunsaturated-fatty-acids-n-3pufas-in-affective-disorders
#3
REVIEW
Valentina Ciappolino, Giuseppe Delvecchio, Carlo Agostoni, Alessandra Mazzocchi, Alfredo Carlo Altamura, Paolo Brambilla
BACKGROUND: Among emerging treatments for depressive disorders several studies suggested that n-3 polyunsaturated fatty acids (n-3PUFAs) supplementation can be used. However, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) differ in terms of biochemistry, metabolism and therapeutic effects. Therefore, a clear picture of their specific and different role on affective disorders has not yet emerged. OBJECTIVES: To investigate the effects of n-3PUFAs on affective disorders including major depression, bipolar disorder and perinatal depression...
December 30, 2016: Journal of Affective Disorders
https://www.readbyqxmd.com/read/28088681/maintenance-effects-of-working-memory-intervention-cogmed-in-children-with-symptomatic-epilepsy
#4
Amanda Fuentes, Elizabeth N Kerr
PURPOSE: To extend previous research documenting the benefits of working memory (WM) intervention (Cogmed) immediately post-intervention in children with epilepsy by assessing the 3-month maintenance effects. METHODS: Participants involved in a previous randomized clinical trial (RCT) were invited to participate if they completed Cogmed within the last 3months (n=15) and additional participants (n=13) were prospectively recruited. Standardized assessments of near-transfer effects (i...
January 12, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28088380/aquatic-exercise-therapy-for-people-with-parkinson-s-disease-a-randomized-controlled-trial
#5
Louise M Carroll, Daniele Volpe, Meg E Morris, Jean Saunders, Amanda M Clifford
OBJECTIVE: To evaluate the effects of aquatic exercise therapy on gait variability and disability compared to usual care for people with Parkinson's disease (PD). DESIGN: Single-blind randomized control trial (RCT). SETTING: A community based hydrotherapy pool in Ireland. PARTICIPANTS: Twenty one individuals with PD (Hoehn-Yahr Stages I-III). INTERVENTIONS: Participants were randomly assigned to either an aquatic exercise therapy group (45 minutes, twice a week for 6 weeks) or a control group that received usual care...
January 11, 2017: Archives of Physical Medicine and Rehabilitation
https://www.readbyqxmd.com/read/28088243/reducing-sedentary-time-in-adults-at-risk-of-type-2-diabetes-process-evaluation-of-the-stand-sedentary-time-and-diabetes-rct
#6
Stuart J H Biddle, Charlotte L Edwardson, Trish Gorely, Emma G Wilmot, Thomas Yates, Myra A Nimmo, Kamlesh Khunti, Melanie J Davies
BACKGROUND: Reducing sedentary behaviour may have important health implications. This study evaluated the potential enablers and barriers for outcomes of a randomised controlled trial (RCT) designed to evaluate a pragmatic education based intervention designed to reduce sedentary (sitting) behaviour in young adults at high risk of type 2 diabetes. METHODS: Data were collected from participants in the intervention group immediately after an educational workshop addressing sedentary time and diabetes risk (n = 71), through phone interviews 6 weeks (n = 45) after the workshop, and at the conclusion of the 12-month trial (n = 10)...
January 14, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28088205/quercetin-improves-macrophage-reverse-cholesterol-transport-in-apolipoprotein-e-deficient-mice-fed-a-high-fat-diet
#7
Yingjie Cui, Pengbo Hou, Fahui Li, Qinghua Liu, Shucun Qin, Guanghai Zhou, Xuelian Xu, Yanhong Si, Shoudong Guo
BACKGROUND: Quercetin, one of the most widely distributed flavonoids in plants, has been demonstrated to reduce hyperlipidaemia and atherosclerotic lesion formation. Reverse cholesterol transport (RCT) plays a crucial role in exporting cholesterol from peripheral cells, which is one mechanism utilized in the prevention and treatment of atherosclerosis. The aim of this study is to investigate whether quercetin reduces lipid accumulation by improving RCT in vivo. METHODS: Apolipoprotein E-deficient mice fed a high-fat diet were used to investigate the effect of quercetin on RCT by an isotope tracing method, and the underlying mechanisms were clarified by molecular techniques...
January 14, 2017: Lipids in Health and Disease
https://www.readbyqxmd.com/read/28088203/a-3-arm-randomised-controlled-trial-of-communicating-healthy-beginnings-advice-by-telephone-chat-to-mothers-with-infants-to-prevent-childhood-obesity
#8
Li Ming Wen, Chris Rissel, Louise A Baur, Alison J Hayes, Huilan Xu, Anna Whelan, Myna Hua, Miranda Shaw, Philayrath Phongsavan
BACKGROUND: With an increasing prevalence of obesity in young children globally, there is an urgent need for the development of effective early interventions. A previous Healthy Beginnings Trial using a nurse-led home visiting program has demonstrated that providing mothers with evidence-based advice can improve maternal practice regarding obesity prevention, and can reduce Body Mass Index (BMI) in the first few years of life. However, the costs for scale-up of home visiting limit its population reach...
January 14, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28087885/absence-of-intestinal-microbiota-increases-%C3%A3-cyclodextrin-stimulated-reverse-cholesterol-transport
#9
Rima H Mistry, Henkjan J Verkade, Uwe J F Tietge
SCOPE: Non-digestible oligosaccharides are used as prebiotics for perceived health benefits, among these modulating lipid metabolism. However, the mechanisms of action are incompletely understood. The present study characterized the impact of dietary ß-cyclodextrin (ßCD, 10%, w/w), a cyclic oligosaccharide, on sterol metabolism and reverse cholesterol transport (RCT) in conventional and also germ-free mice to establish dependency on metabolism by intestinal bacteria. METHODS AND RESULTS: In conventional ßCD-fed C57BL/6J wild-type mice plasma cholesterol decreased significantly (-40%, p<0...
January 14, 2017: Molecular Nutrition & Food Research
https://www.readbyqxmd.com/read/28087371/use-of-the-heart-pathway-with-high-sensitivity-cardiac-troponins-a-secondary-analysis
#10
Simon A Mahler, Jason P Stopyra, Fred S Apple, Robert F Riley, Gregory B Russell, Brian C Hiestand, James W Hoekstra, Cedric W Lefebvre, Bret A Nicks, David M Cline, Kim L Askew, David M Herrington, Gregory L Burke, Chadwick D Miller
OBJECTIVES: The HEART Pathway combines a decision aid and serial contemporary cardiac troponin I (cTnI) measures to achieve >99% sensitivity for major adverse cardiac events (MACE) at 30days and early discharge rates >20%. However, the impact of integrating high-sensitivity troponin (hs-cTn) measures into the HEART Pathway has yet to be determined. In this analysis we compare test characteristics of the HEART Pathway using hs-cTnI, hs-cTnT, or cTnI. DESIGN &METHODS: A secondary analysis of participants enrolled in the HEART Pathway RCT was conducted...
January 10, 2017: Clinical Biochemistry
https://www.readbyqxmd.com/read/28087126/cardiac-lymphatics-a-new-avenue-for-therapeutics
#11
REVIEW
Taina Vuorio, Annakaisa Tirronen, Seppo Ylä-Herttuala
Recent progress in lymphatic vessel biology and in novel imaging techniques has established the importance of the lymphatic vasculature as part of the cardiovascular system. The lymphatic vessel network regulates many physiological processes important for heart function such as fluid balance, transport of extravasated proteins, and trafficking of immune cells. Therefore, lymphangiogenic therapy could be beneficial in the treatment of cardiovascular diseases, for example by improving reverse cholesterol transport (RCT) from atherosclerotic lesions or by resolving edema and fibrosis after myocardial infarction...
January 10, 2017: Trends in Endocrinology and Metabolism: TEM
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
#12
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/28086890/feasibility-and-preliminary-efficacy-of-the-heyman-healthy-lifestyle-program-for-young-men-a-pilot-randomised-controlled-trial
#13
Lee M Ashton, Philip J Morgan, Melinda J Hutchesson, Megan E Rollo, Clare E Collins
BACKGROUND: In young men, unhealthy lifestyle behaviours can be detrimental to their physical and/or mental health and set them on a negative health trajectory into adulthood. Despite this, there is a lack of evidence to guide development of effective health behaviour change interventions for young men. This study assessed the feasibility and preliminary efficacy of the 'HEYMAN' (Harnessing Ehealth to enhance Young men's Mental health, Activity and Nutrition) healthy lifestyle program for young men...
January 13, 2017: Nutrition Journal
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
#14
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/28081585/drug-eluting-stent-placement-versus-coronary-artery-bypass-surgery-for-unprotected-left-main-coronary-artery-disease-a-meta-analysis-of-randomized-controlled-trials
#15
Sunil Upadhaya, Ramkaji Baniya, Seetharamprasad Madala, Suresh Kumar Subedi, Jahangir Khan, Ravi Kanth Velagapudi, Ghassan Bachuwa
BACKGROUND: Coronary artery bypass grafting (CABG) is the standard of care for treating left main coronary lesions. However, recently published randomized controlled trials (RCT) have shown conflicting results. We sought to compare clinical outcomes of percutaneous coronary intervention (PCI) with drug-eluting stent placement to CABG using a meta-analysis of randomized controlled trials. METHODS: A systemic search of Pubmed, Scopus, Cochrane library, and Clinicaltrials...
January 12, 2017: Journal of Cardiac Surgery
https://www.readbyqxmd.com/read/28081369/randomized-controlled-ethanol-cookstove-intervention-and-blood-pressure-in-pregnant-nigerian-women
#16
Donee Alexander, Amanda Northcross, Nathaniel Wilson, Anindita Dutta, Rishi Pandya, Tope Ibigbami, Damilola Adu, John Olamijulo, Oludare Morhason-Bello, Theodore Karrison, Oladosu Ojengbede, Christopher O Olopade
RATIONALE: Hypertension during pregnancy is a leading cause of maternal mortality. Exposure to household air pollution (HAP) elevates blood pressure (BP). OBJECTIVES: Investigate ability of clean cookstove intervention to lower BP during pregnancy. METHODS: A randomized, controlled trial (RCT) was conducted in Nigeria. Pregnant women cooking with kerosene or firewood were randomly assigned to ethanol (n = 162) or control arms (n = 162). BP measurements were taken during 6 antenatal visits...
January 12, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28080169/family-oriented-support-famos-development-and-feasibility-of-a-psychosocial-intervention-for-families-of-childhood-cancer-survivors
#17
Hanin Salem, Christoffer Johansen, Kjeld Schmiegelow, Jeanette Falck Winther, Peder Skov Wehner, Henrik Hasle, Steen Rosthøj, Anne E Kazak, Pernille E Bidstrup
BACKGROUND: We developed and tested the feasibility of a manualized psychosocial intervention, FAMily-Oriented Support (FAMOS), a home-based psychosocial intervention for families of childhood cancer survivors. The aim of the intervention is to support families in adopting healthy strategies to cope with the psychological consequences of childhood cancer. The intervention is now being evaluated in a nationwide randomized controlled trial (RCT). METHODS AND DESIGN: FAMOS is based on principles of family systems therapy and cognitive behavioral therapy, and is delivered in six sessions at home...
January 12, 2017: Acta Oncologica
https://www.readbyqxmd.com/read/28079708/parenteral-nutrition-in-the-critically-ill
#18
Jan Gunst, Greet Van den Berghe
PURPOSE OF REVIEW: Feeding guidelines have recommended early, full nutritional support in critically ill patients to prevent hypercatabolism and muscle weakness. Early enteral nutrition was suggested to be superior to early parenteral nutrition. When enteral nutrition fails to meet nutritional target, it was recommended to administer supplemental parenteral nutrition, albeit with a varying starting point. Sufficient amounts of amino acids were recommended, with addition of glutamine in subgroups...
January 11, 2017: Current Opinion in Critical Care
https://www.readbyqxmd.com/read/28079154/local-anesthesia-for-transrectal-ultrasound-guided-biopsy-of-the-prostate-a-meta-analysis
#19
Mingchao Li, Zhengyun Wang, Hao Li, Jun Yang, Ke Rao, Tao Wang, Shaogang Wang, Jihong Liu
A meta-analysis was performed to evaluate the efficacy of local anesthesia in alleviating pain during prostate biopsy. We searched relevant articles in PubMed and Embase. The included studies should be randomized controlled trials (RCT) using local anesthesia to alleviate pain during biopsy, which was recorded by a pain scale. Analgesic efficacy of different local anesthesia techniques were analyzed, including intrarectal local anesthesia (IRLA), periprostatic nerve block (PNB), pelvic plexus block (PPB) and intraprostatic local anesthesia (IPLA)...
January 12, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28078669/maintenance-phase-in-puva-phototherapy-of-early-stage-mycosis-fungoides-a-critically-appraised-topic
#20
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
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