Meta-analysis evaluating music interventions for anxiety and pain in surgery.

Science.gov (United States)

Kühlmann, A Y R; de Rooij, A; Kroese, L F; van Dijk, M; Hunink, M G M; Jeekel, J

2018-06-01

This study aimed to evaluate anxiety and pain following perioperative music interventions compared with control conditions in adult patients. Eleven electronic databases were searched for full-text publications of RCTs investigating the effect of music interventions on anxiety and pain during invasive surgery published between 1 January 1980 and 20 October 2016. Results and data were double-screened and extracted independently. Random-effects meta-analysis was used to calculate effect sizes as standardized mean differences (MDs). Heterogeneity was investigated in subgroup analyses and metaregression analyses. The review was registered in the PROSPERO database as CRD42016024921. Ninety-two RCTs (7385 patients) were included in the systematic review, of which 81 were included in the meta-analysis. Music interventions significantly decreased anxiety (MD -0·69, 95 per cent c.i. -0·88 to -0·50; P < 0·001) and pain (MD -0·50, -0·66 to -0·34; P < 0·001) compared with controls, equivalent to a decrease of 21 mm for anxiety and 10 mm for pain on a 100-mm visual analogue scale. Changes in outcome corrected for baseline were even larger: MD -1·41 (-1·89 to -0·94; P < 0·001) for anxiety and -0·54 (-0·93 to -0·15; P = 0·006) for pain. Music interventions provided during general anaesthesia significantly decreased pain compared with that in controls (MD -0·41, -0·64 to -0·18; P < 0·001). Metaregression analysis found no significant association between the effect of music interventions and age, sex, choice and timing of music, and type of anaesthesia. Risk of bias in the studies was moderate to high. Music interventions significantly reduce anxiety and pain in adult surgical patients. © 2018 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

Family Intervention in First-Episode Psychosis

Directory of Open Access Journals (Sweden)

Anvar Sadath

2015-11-01

Full Text Available Family interventions have produced benefits on clinical and family outcomes in long standing psychosis. However, little is known about the efficacy of such interventions in the early stages of psychosis. This article reviews published research over the last two decades on family intervention in first-episode psychosis. Electronic databases, such as PubMed, PsycINFO, and ScienceDirect, have been systematically searched. In addition, an exhaustive Internet search was also carried out using Google and Google Scholar to identify the potential studies that evaluated family interventions in first-episode psychosis. We have identified seven reports of five randomized controlled trials (RCTs and five non-randomized and uncontrolled studies of family intervention. Our review on 12 reports of family intervention studies has shown mixed effects on outcomes in first-episode psychosis. Most of the reports showed no added benefits or very short-term benefits on primary clinical or family outcome variables. There is a dearth of family intervention studies in first-episode psychosis. More RCTs are needed to reach reliable conclusions.

Long-term child follow-up after large obstetric randomised controlled trials for the evaluation of perinatal interventions: a systematic review of the literature

NARCIS (Netherlands)

Teune, M. J.; van Wassenaer, A. G.; Malin, G. L.; Asztalos, E.; Alfirevic, Z.; Mol, B. W. J.; Opmeer, B. C.

2013-01-01

Although the hope is that many perinatal interventions are performed with an ultimate aim to improve the long-term health and development of the child, long-term outcome is rarely used as a primary end-point in perinatal randomised controlled trials (RCTs). To evaluate how often and with which tools

Heterogeneity of wound outcome measures in RCTs of treatments for VLUs: a systematic review.

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Gethin, G; Killeen, F; Devane, D

2015-05-01

Venous leg ulcers (VLUs) affect up to 4% of the population aged over 65 years. Outcomes of randomised controlled trials (RCTs) in VLUs are important to guide clinical and resource decision making. Our objective was to identify what endpoints and wound bed outcomes were assessed in RCTs in VLUs; how these were assessed and what reference was made to validity and reliability of methods used. A systematic review of all full text RCTs, published in English, from 1998-2013. Our criteria were met by 102 studies. There were 78 different endpoints recorded, the majority (n=34) related to healing and were evaluated at 12 different times points. Size was the most frequently reported outcome measure (n=99), with photographs, tissue type, exudate, odour and pain also recorded. There was poor reporting of methods used to assess outcomes. Visual analogue scales predominated as a method of assessment, but 95% of studies made no reference to the validity or reliability of assessment methods. Future research in VLUs requires standards for measuring outcomes with acceptable inter-rater reliability and validated measures of patient-reported outcomes.

Interventions for heartburn in pregnancy.

Science.gov (United States)

Phupong, Vorapong; Hanprasertpong, Tharangrut

2015-09-19

compared with placebo or no treatmentTwo trials evaluated any pharmaceutical treatment compared with placebo or no treatment. One trial examined a treatment rarely used nowadays (intramuscular prostigmine 0.5 mg versus placebo). One trial evaluated the effect of magnesium and aluminium hydroxide plus simethicone liquid and tablet compared with placebo. For the primary outcome of this review (relief of heartburn), women who received pharmaceutical treatment reported complete heartburn relief more often than women receiving no treatment or placebo (risk ratio (RR) 1.85, 95% confidence interval (CI) 1.36 to 2.50 in two RCTs of 256 women, I(2) = 0%, moderate-quality evidence). Data on partial relief of heartburn were heterogenous and showed no clear difference (average RR 1.35, 95% CI 0.38 to 4.76 in two RCTs of 256 women, very low-quality evidence). In terms of secondary outcomes, there was no clear difference in the rate of side effects between the pharmaceutical treatment group and the placebo/no treatment group (RR 0.63, 95% CI 0.21 to 1.89 in two RCTs of 256 women, very low-quality evidence). Pharmacological intervention versus advice on dietary and lifestyle choicesOne study compared 1 g of sucralfate with advice on dietary and lifestyle choices in treating heartburn. More women in the sucralfate group experienced complete relief of heartburn compared to women who received advice on diet and lifestyle choices (RR 2.41, 95% CI 1.42 to 4.07; participants = 65; studies = one). The only secondary outcome of interest addressed by this trial was side effects. The evidence was not clear on intervention side effects rate between the two groups (RR 1.74, 95% CI 0.07 to 41.21; participants = 66; studies = one). There was only one instance of side effects in the pharmacological group. Acupuncture compared with no treatmentOne trial evaluated acupuncture compared with no treatment but did not report data relating to this review's primary outcome (relief of heartburn). In terms of

Clinical pharmacist interventions to support adherence to thrombopreventive therapy

DEFF Research Database (Denmark)

Hedegaard, Ulla

The three papers in the thesis were based on two randomised controlled trials (RCTs) on in-hospital clinical pharmacist interventions for improvement of adherence to thrombopreventive therapy in two different populations: outpatients with hypertension and patients with acute stroke/transient isch......The three papers in the thesis were based on two randomised controlled trials (RCTs) on in-hospital clinical pharmacist interventions for improvement of adherence to thrombopreventive therapy in two different populations: outpatients with hypertension and patients with acute stroke...... individualised interventions and team-based care, e.g. integrating a clinical pharmacist with particular focus on patients’ drug-related problems. One approach with growing evidence of improving medication adherence is motivational interviewing (MI). So far, no clinical pharmacist intervention using MI has...... targeted patients with hypertension or stroke in a hospital care setting. Thus, the aim of this thesis was to develop and evaluate in-hospital pharmacist interventions including MI to improve adherence to primary and secondary thrombopreventive therapy. The first study was a RCT, which investigated...

Internet Interventions for Hearing Loss.

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Thorén, Elisabet Sundewall; Öberg, Marie; Andersson, Gerhard; Lunner, Thomas

2015-09-01

The purpose of the two studies presented in this research forum article was to develop audiological rehabilitation programs for experienced hearing aid users and evaluate them in online versions. In this research forum article, the differences between the two studies are discussed. Two randomized controlled trials (RCTs) were performed evaluating the efficacy of online rehabilitation, including professional guidance by an audiologist. In each RCT, the effects of the online programs were compared with the effects measured in a control group. The results from the first RCT showed a significant increase in activity and participation for both groups with participants in the intervention group improving more than those in the control group. At the 6-month follow-up, after the study, the significant increase was maintained; however, amounts of increase in the two groups were no longer significantly different. The results from the second RCT showed significant increase in activity and participation for the intervention group, although the control group did not improve. The results from the RCTs provide evidence that the Internet can be used to deliver rehabilitation to hearing-aid users and that their problems are reduced by the intervention; however, the content of the online rehabilitation program requires further investigation.

CONSORT to community: translation of an RCT to a large-scale community intervention and learnings from evaluation of the upscaled program.

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Moores, Carly Jane; Miller, Jacqueline; Perry, Rebecca Anne; Chan, Lily Lai Hang; Daniels, Lynne Allison; Vidgen, Helen Anna; Magarey, Anthea Margaret

2017-11-29

Translation encompasses the continuum from clinical efficacy to widespread adoption within the healthcare service and ultimately routine clinical practice. The Parenting, Eating and Activity for Child Health (PEACH™) program has previously demonstrated clinical effectiveness in the management of child obesity, and has been recently implemented as a large-scale community intervention in Queensland, Australia. This paper aims to describe the translation of the evaluation framework from a randomised controlled trial (RCT) to large-scale community intervention (PEACH™ QLD). Tensions between RCT paradigm and implementation research will be discussed along with lived evaluation challenges, responses to overcome these, and key learnings for future evaluation conducted at scale. The translation of evaluation from PEACH™ RCT to the large-scale community intervention PEACH™ QLD is described. While the CONSORT Statement was used to report findings from two previous RCTs, the REAIM framework was more suitable for the evaluation of upscaled delivery of the PEACH™ program. Evaluation of PEACH™ QLD was undertaken during the project delivery period from 2013 to 2016. Experiential learnings from conducting the evaluation of PEACH™ QLD to the described evaluation framework are presented for the purposes of informing the future evaluation of upscaled programs. Evaluation changes in response to real-time changes in the delivery of the PEACH™ QLD Project were necessary at stages during the project term. Key evaluation challenges encountered included the collection of complete evaluation data from a diverse and geographically dispersed workforce and the systematic collection of process evaluation data in real time to support program changes during the project. Evaluation of large-scale community interventions in the real world is challenging and divergent from RCTs which are rigourously evaluated within a more tightly-controlled clinical research setting. Constructs

Combined diet and exercise interventions for preventing gestational diabetes mellitus.

Science.gov (United States)

Shepherd, Emily; Gomersall, Judith C; Tieu, Joanna; Han, Shanshan; Crowther, Caroline A; Middleton, Philippa

2017-11-13

Gestational diabetes mellitus (GDM) is associated with a wide range of adverse health consequences for women and their infants in the short and long term. With an increasing prevalence of GDM worldwide, there is an urgent need to assess strategies for GDM prevention, such as combined diet and exercise interventions. This is an update of a Cochrane review that was first published in 2015. To assess the effects of diet interventions in combination with exercise interventions for pregnant women for preventing GDM, and associated adverse health consequences for the mother and her infant/child. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (27 November 2016) and reference lists of retrieved studies. We included randomised controlled trials (RCTs) and cluster-RCTs, comparing combined diet and exercise interventions with no intervention (i.e. standard care), that reported on GDM diagnosis as an outcome. Quasi-RCTs were excluded. Cross-over trials were not eligible for inclusion. We planned to include RCTs comparing two or more different diet/exercise interventions, however none were identified. Two review authors independently assessed study eligibility, extracted data, assessed the risk of bias of the included trials and assessed quality of evidence for selected maternal and infant/child outcomes using the GRADE approach. We checked data for accuracy. In this update, we included 23 RCTs (involving 8918 women and 8709 infants) that compared combined diet and exercise interventions with no intervention (standard care). The studies varied in the diet and exercise programs evaluated and health outcomes reported. None reported receiving funding from a drug manufacturer or agency with interests in the results. Overall risk of bias was judged to be unclear due to the lack of methodological detail reported. Most studies were undertaken in high-income countries.For our primary review outcomes, there was a possible reduced risk of GDM in the diet and

Event-rate and delta inflation when evaluating mortality as a primary outcome from randomized controlled trials of nutritional interventions during critical illness: a systematic review.

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Summers, Matthew J; Chapple, Lee-anne S; McClave, Stephen A; Deane, Adam M

2016-04-01

There is a lack of high-quality evidence that proves that nutritional interventions during critical illness reduce mortality. We evaluated whether power calculations for randomized controlled trials (RCTs) of nutritional interventions that used mortality as the primary outcome were realistic, and whether overestimation was systematic in the studies identified to determine whether this was due to overestimates of event rate or delta. A systematic review of the literature between 2005 and 2015 was performed to identify RCTs of nutritional interventions administered to critically ill adults that had mortality as the primary outcome. Predicted event rate (predicted mortality during the control), predicted mortality during intervention, predicted delta (predicted difference between mortality during the control and intervention), actual event rate (observed mortality during control), observed mortality during intervention, and actual delta (difference between observed mortality during the control and intervention) were recorded. The event-rate gap (predicted event rate minus observed event rate), the delta gap (predicted delta minus observed delta), and the predicted number needed to treat were calculated. Data are shown as median (range). Fourteen articles were extracted, with power calculations provided for 10 studies. The predicted event rate was 29.9% (20.0–52.4%), and the predicted delta was 7.9% (3.0–20.0%). If the study hypothesis was proven correct then, on the basis of the power calculations, the number needed to treat would have been 12.7 (5.0–33.3) patients. The actual event rate was 25.3% (6.1–50.0%), the observed mortality during the intervention was 24.4% (6.3–39.7%), and the actual delta was 0.5% (−10.2–10.3%), such that the event-rate gap was 2.6% (−3.9–23.7%) and delta gap was 7.5% (3.2–25.2%). Overestimates of delta occur frequently in RCTs of nutritional interventions in the critically ill that are powered to determine a mortality

Systematic review and network meta-analysis of interventions for fibromyalgia: a protocol

NARCIS (Netherlands)

Busse, Jason W.; Ebrahim, Shanil; Connell, Gaelan; Coomes, Eric A.; Bruno, Paul; Malik, Keshena; Torrance, David; Ngo, Trung; Kirmayr, Karin; Avrahami, Daniel; Riva, John J.; Struijs, Peter; Brunarski, David; Burnie, Stephen J.; LeBlanc, Frances; Steenstra, Ivan A.; Mahood, Quenby; Thorlund, Kristian; Montori, Victor M.; Sivarajah, Vishalini; Alexander, Paul; Jankowski, Milosz; Lesniak, Wiktoria; Faulhaber, Markus; Bała, Małgorzata M.; Schandelmaier, Stefan; Guyatt, Gordon H.

2013-01-01

Fibromyalgia is associated with substantial socioeconomic loss and, despite considerable research including numerous randomized controlled trials (RCTs) and systematic reviews, there exists uncertainty regarding what treatments are effective. No review has evaluated all interventional studies for

Evaluation of Wet Cupping Therapy: Systematic Review of Randomized Clinical Trials.

Science.gov (United States)

Al Bedah, Abdullah M N; Khalil, Mohamed K M; Posadzki, Paul; Sohaibani, Imen; Aboushanab, Tamer Shaaban; AlQaed, Meshari; Ali, Gazzaffi I M

2016-10-01

Wet cupping is a widely used traditional therapy in many countries, which justifies a continuous scientific evaluation of its efficacy and safety. To perform a systematic review to critically evaluate and update the available evidence of wet cupping in traditional and complementary medicine. Ten electronic databases were searched from their inceptions to February 2016. Included studies were randomized clinical trials (RCTs) that evaluated wet cupping against any type of control interventions in patients with any clinical condition, as well as healthy individuals. Cochrane risk of bias tool was used to appraise the included RCTs. Fourteen RCTs met the eligibility criteria. The included studies evaluated the following clinical conditions: nonspecific low back pain (NSLBP), hypertension, brachialgia, carpal tunnel syndrome (CTS), chronic neck pain, metabolic syndrome, migraine headaches, oxygen saturation in smokers with chronic obstructive pulmonary disease (COPD), and oral and genital ulcers due to Behçet disease. Two RCTs evaluated physiologic and biochemical parameters of healthy individuals. Overall, 9 RCTs favored wet cupping over various control interventions in NSLBP (n = 2), hypertension (n = 1), brachialgia (n = 1), CTS (n = 1), chronic neck pain (n = 2), oxygen saturation in smokers with COPD (n = 1), and oral and genital ulcers due to Behçet disease (n = 1). Five RCTs showed no statistically significant between-group differences: NSLBP (n = 1), metabolic syndrome (n = 1), migraine headaches (n = 1), and physiologic and biochemical parameters of healthy individuals (n = 2). Included RCTs had a variable risk of bias across all domains and suffered methodologic limitations. There is a promising evidence in favor of the use of wet cupping for musculoskeletal pain, specifically NSLBP, neck pain, CTS, and brachialgia. Better-quality trials are needed to generate solid evidence and firmly inform policy makers.

Quality of reporting of randomised controlled trials of herbal interventions in ASEAN Plus Six Countries: a systematic review.

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Pratoomsoot, Chayanin; Sruamsiri, Rosarin; Dilokthornsakul, Piyameth; Chaiyakunapruk, Nathorn

2015-01-01

Many randomised controlled trials (RCTs) of herbal interventions have been conducted in the ASEAN Communities. Good quality reporting of RCTs is essential for assessing clinical significance. Given the importance ASEAN placed on herbal medicines, the reporting quality of RCTs of herbal interventions among the ASEAN Communities deserved a special attention. To systematically review the quality of reporting of RCTs of herbal interventions conducted in the ASEAN Plus Six Countries. Searches were performed using PubMed, EMBASE, The Cochrane Library, and Allied and Complementary Medicine (AMED), from inception through October 2013. These were limited to studies specific to humans and RCTs. Herbal species search terms were based on those listed in the National List of Essential Medicines [NLEM (Thailand, 2011)]. Studies conducted in the ASEAN Plus Six Countries, published in English were included. Seventy-one articles were identified. Thirty (42.25%) RCTs were from ASEAN Countries, whereas 41 RCTs (57.75%) were from Plus Six Group. Adherence to the recommended CONSORT checklist items for reporting of RCTs of herbal interventions among ASEAN Plus Six Countries ranged from 0% to 97.18%. Less than a quarter of the RCTs (18.31%) reported information on standardisation of the herbal products. However, the scope of our interventions of interest was limited to those developed from 20 herbal species listed in the NLEM of Thailand. The present study highlights the need to improve reporting quality of RCTs of herbal interventions across ASEAN Plus Six Communities.

The role of intervention mapping in designing disease prevention interventions: A systematic review of the literature.

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Garba, Rayyan M; Gadanya, Muktar A

2017-01-01

To assess the role of Intervention Mapping (IM) in designing disease prevention interventions worldwide. Systematic search and review of the relevant literature-peer-reviewed and grey-was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. Only five of the twenty two included studies reviewed were RCTs that compared intervention using IM protocol with placebo intervention, and provided the outcomes in terms of percentage increase in the uptake of disease-prevention programmes, and only one of the five studies provided an effect measure in the form of relative risk (RR = 1.59, 95% CI = 1.08-2.34, p = 0.02). Of the five RCTs, three were rated as strong evidences, one as a medium evidence and one as a weak evidence, and they all reported statistically significant difference between the two study groups, with disease prevention interventions that have used the intervention mapping approach generally reported significant increases in the uptake of disease-prevention interventions, ranging from 9% to 28.5% (0.0001 ≤ p ≤ 0.02), On the other hand, all the 22 studies have successfully identified the determinants of the uptake of disease prevention interventions that is essential to the success of disease prevention programmes. Intervention Mapping has been successfully used to plan, implement and evaluate interventions that showed significant increase in uptake of disease prevention programmes. This study has provided a good understanding of the role of intervention mapping in designing disease prevention interventions, and a good foundation upon which subsequent reviews can be guided.

Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

Science.gov (United States)

2014-01-01

Background Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann–Whitney test. Results The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck’s disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0–1) and for the shoulder RCTs 3.0 (range 0–5) (p = 0.012). Conclusion Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically

Identifying reports of randomized controlled trials (RCTs) via a hybrid machine learning and crowdsourcing approach.

Science.gov (United States)

Wallace, Byron C; Noel-Storr, Anna; Marshall, Iain J; Cohen, Aaron M; Smalheiser, Neil R; Thomas, James

2017-11-01

Identifying all published reports of randomized controlled trials (RCTs) is an important aim, but it requires extensive manual effort to separate RCTs from non-RCTs, even using current machine learning (ML) approaches. We aimed to make this process more efficient via a hybrid approach using both crowdsourcing and ML. We trained a classifier to discriminate between citations that describe RCTs and those that do not. We then adopted a simple strategy of automatically excluding citations deemed very unlikely to be RCTs by the classifier and deferring to crowdworkers otherwise. Combining ML and crowdsourcing provides a highly sensitive RCT identification strategy (our estimates suggest 95%-99% recall) with substantially less effort (we observed a reduction of around 60%-80%) than relying on manual screening alone. Hybrid crowd-ML strategies warrant further exploration for biomedical curation/annotation tasks. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Behavioral interventions for adolescents with type 1 diabetes

DEFF Research Database (Denmark)

Hampson, S. E.; Skinner, T. C.; Hart, J.

2000-01-01

OBJECTIVE - To evaluate the effectiveness of behavioral interventions for adolescents with type 1 diabetes based on a systematic review of the literature. RESEARCH DESIGN AND METHODS - The literature was identified by searching 11 electronic databases, hand-searching 3 journals from their start...... dates, and contacting individual researchers. Only articles that reported evaluations of behavioral (including educational and psychosocial) interventions for adolescents (age range 9-21 years) with type 1 diabetes that included a control group were included in the present review. Data summarizing...... were RCTs. Effect sizes could be calculated for 18 interventions. The overall mean effect size calculated across all outcomes was 0.33 (median 0.21), indicating that these interventions have a small- to medium-sized beneficial effect on diabetes management. Interventions that were theoretically based...

Evaluation of a Mobile Phone-Based Intervention to Increase Parents' Knowledge About the Measles-Mumps-Rubella Vaccination and Their Psychological Empowerment: Mixed-Method Approach.

Science.gov (United States)

Fadda, Marta; Galimberti, Elisa; Fiordelli, Maddalena; Schulz, Peter Johannes

2018-03-07

There is mixed evidence on the effectiveness of vaccination-related interventions. A major limitation of most intervention studies is that they do not apply randomized controlled trials (RCTs), the method that, over the last 2 decades, has increasingly been considered as the only method to provide proof of the effectiveness of an intervention and, consequently, as the most important instrument in deciding whether to adopt an intervention or not. This study, however, holds that methods other than RCTs also can produce meaningful results. The aim of this study was to evaluate 2 mobile phone-based interventions aimed at increasing parents' knowledge of the measles-mumps-rubella (MMR) vaccination (through elements of gamification) and their psychological empowerment (through the use of narratives), respectively. The 2 interventions were part of an RCT. We conducted 2 studies with the RCT participants: a Web-based survey aimed at assessing their rating of the tool regarding a number of qualities such as usability and usefulness (N=140), and qualitative telephonic interviews to explore participants' experiences with the app (N=60). The results of the survey showed that participants receiving the knowledge intervention (alone or together with the empowerment intervention) liked the app significantly better compared with the group that only received the empowerment intervention (F 2,137 =15.335; Pbenefits of the vaccination at the same time. International Standard Randomized Controlled Trial Number 30768813; http://www.isrctn.com/ ISRCTN30768813 (Archived by WebCite at http://www.webcitation.org/6xOQSJ3w8). ©Marta Fadda, Elisa Galimberti, Maddalena Fiordelli, Peter Johannes Schulz. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 07.03.2018.

Inadequate description of educational interventions in ongoing randomized controlled trials

Directory of Open Access Journals (Sweden)

Pino Cécile

2012-05-01

Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

Self-management interventions for adults with chronic kidney disease: a scoping review.

Science.gov (United States)

Donald, Maoliosa; Kahlon, Bhavneet Kaur; Beanlands, Heather; Straus, Sharon; Ronksley, Paul; Herrington, Gwen; Tong, Allison; Grill, Allan; Waldvogel, Blair; Large, Chantel A; Large, Claire L; Harwood, Lori; Novak, Marta; James, Matthew T; Elliott, Meghan; Fernandez, Nicolas; Brimble, Scott; Samuel, Susan; Hemmelgarn, Brenda R

2018-03-22

To systematically identify and describe self-management interventions for adult patients with chronic kidney disease (CKD). Community-based. Adults with CKD stages 1-5 (not requiring kidney replacement therapy). Self-management strategies for adults with CKD. Using a scoping review, electronic databases and grey literature were searched in October 2016 to identify self-management interventions for adults with CKD stages 1-5 (not requiring kidney replacement therapy). Randomised controlled trials (RCTs), non-RCTs, qualitative and mixed method studies were included and study selection and data extraction were independently performed by two reviewers. Outcomes included behaviours, cognitions, physiological measures, symptoms, health status and healthcare. Fifty studies (19 RCTs, 7 quasi-experimental, 5 observational, 13 pre-post intervention, 1 mixed method and 5 qualitative) reporting 45 interventions were included. The most common intervention topic was diet/nutrition and interventions were regularly delivered face to face. Interventions were administered by a variety of providers, with nursing professionals the most common health professional group. Cognitions (ie, changes in general CKD knowledge, perceived self-management and motivation) were the most frequently reported outcome domain that showed improvement. Less than 1% of the interventions were co-developed with patients and 20% were based on a theory or framework. There was a wide range of self-management interventions with considerable variability in outcomes for adults with CKD. Major gaps in the literature include lack of patient engagement in the design of the interventions, with the majority of interventions not applying a behavioural change theory to inform their development. This work highlights the need to involve patients to co-developed and evaluate a self-management intervention based on sound theories and clinical evidence. © Article author(s) (or their employer(s) unless otherwise stated in the

Effects of non-pharmacological interventions on inflammatory biomarker expression in patients with fibromyalgia: a systematic review.

Science.gov (United States)

Sanada, Kenji; Díez, Marta Alda; Valero, Montserrat Salas; Pérez-Yus, María Cruz; Demarzo, Marcelo M P; García-Toro, Mauro; García-Campayo, Javier

2015-09-26

Fibromyalgia (FM) is a prevalent disorder. However, few studies have evaluated the effect of treatment interventions on biomarker expression. The aim of this review was to explore the efficacy of non-pharmacological interventions on inflammatory biomarker expression, specifically cytokines, neuropeptides and C-reactive protein (CRP), in FM patients. A literature search using PubMed, EMBASE, PsycINFO and the Cochrane library was performed from January 1990 to March 2015. Randomized controlled trials (RCTs) and non-RCTs published in English, French or Spanish were eligible. Twelve articles with a total of 536 participants were included. After exercise, multidisciplinary, or dietary interventions in FM patients, interleukin (IL) expression appeared reduced, specifically serum IL-8 and IL-6 (spontaneous, lipopolysaccharide (LPS)-induced, or serum). Furthermore, the changes to insulin-like growth factor 1 (IGF-1) levels might indicate a beneficial role for fatigue in obese FM patients. In contrast, evidence of changes in neuropeptide and CRP levels seemed inconsistent. Despite minimal evidence, our findings indicate that exercise interventions might act as an anti-inflammatory treatment in FM patients and ameliorate inflammatory status, especially for pro-inflammatory cytokines. Additional RCTs focused on the changes to inflammatory biomarker expression after non-pharmacological interventions in FM patients are needed.

Effectiveness and Appropriateness of mHealth Interventions for Maternal and Child Health: Systematic Review.

Science.gov (United States)

Chen, Huan; Chai, Yanling; Dong, Le; Niu, Wenyi; Zhang, Puhong

2018-01-09

The application of mobile health (mHealth) technology in reproductive, maternal, newborn, and child health (RMNCH) is increasing worldwide. However, best practice and the most effective mHealth interventions have not been reviewed systematically. A systematic review and meta-analysis of studies of mHealth interventions for RMNCH around the world were conducted to investigate their characteristics as well as the features and effectiveness of mHealth interventions. Studies of mHealth interventions for RMNCH between January 2011 and December 2016 were retrieved from 6 databases (PubMed, EMBASE, Global Health, China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, and Wanfang Data Knowledge Service Medium). Comparable studies were included in a random-effects meta-analysis for both exclusive breastfeeding (EBF) and antenatal checks (ANC). Descriptive analyses were conducted for mHealth studies with a range of study designs. Analyses of 245 studies were included, including 51 randomized controlled trials (RCTs). Results showed that there are increasing numbers of studies on mHealth interventions for RMNCH. Although 2 meta-analysis, one with 2 RCTs on EBF (odds ratio [OR] 2.03, 95% CI 1.34-3.08, I 2 =25%) and the other with 3 RCTs on ANC (OR 1.43, 95% CI 1.13-1.79, I 2 =78%), showed that mHealth interventions are more effective than usual care, almost half (43%) of RCTs showed negative or unclear results on mHealth interventions. Functions described in mHealth interventions were diverse, and the health stages covered were broad. However, single function or single stage appeared to be dominant among mHealth interventions compared with multiple functions or stages. More rigorous evaluations are needed to draw consistent conclusions and to analyze mHealth products with multiple functions, especially those popular in the app markets. ©Huan Chen, Yanling Chai, Le Dong, Wenyi Niu, Puhong Zhang. Originally published in JMIR Mhealth and Uhealth

Preconceptional motivational interviewing interventions to reduce alcohol-exposed pregnancy risk.

Science.gov (United States)

Ingersoll, Karen S; Ceperich, Sherry D; Hettema, Jennifer E; Farrell-Carnahan, Leah; Penberthy, J Kim

2013-04-01

Alcohol exposed pregnancy (AEP) is a leading cause of preventable birth defects. While randomized controlled trials (RCTs) have shown that multi-session motivational interviewing-based interventions reduce AEP risk, a one-session intervention could facilitate broader implementation. The purposes of this study were to: (1) test a one-session motivational AEP prevention intervention for community women and (2) compare outcomes to previous RCTs. Participants at risk for AEP (N=217) were randomized to motivational interviewing+assessment feedback (EARLY), informational video, or informational brochure conditions. Outcomes were drinks per drinking day (DDD), ineffective contraception rate, and AEP risk at 3 and 6 months. All interventions were associated with decreased DDD, ineffective contraception rate, and AEP risk. Participants who received EARLY had larger absolute risk reductions in ineffective contraception and AEP risk, but not DDD. Effect sizes were compared to previous RCTs. The one-session EARLY intervention had less powerful effects than multi-session AEP prevention interventions among community women, but may provide a new option in a continuum of preventive care. Copyright © 2013 Elsevier Inc. All rights reserved.

Rehabilitation Interventions for Improving Social Participation After Stroke: A Systematic Review and Meta-analysis.

Science.gov (United States)

Obembe, Adebimpe O; Eng, Janice J

2016-05-01

Despite the fact that social participation is considered a pivotal outcome of a successful recovery after stroke, there has been little attention on the impact of activities and services on this important domain. To present a systematic review and meta-analysis from randomized controlled trials (RCTs) on the effects of rehabilitation interventions on social participation after stroke. A total of 8 electronic databases were searched for relevant RCTs that evaluated the effects of an intervention on the outcome of social participation after stroke. Reference lists of selected articles were hand searched to identify further relevant studies. The methodological quality of the studies was assessed using the Physiotherapy Evidence Database Scale. Standardized mean differences (SMDs) and confidence intervals (CIs) were estimated using fixed- and random-effect models. In all, 24 RCTs involving 2042 stroke survivors were identified and reviewed, and 21 were included in the meta-analysis. There was a small beneficial effect of interventions that utilized exercise on social participation (10 studies; SMD = 0.43; 95% CI = 0.09, 0.78;P= .01) immediately after the program ended. Exercise in combination with other interventions (13 studies; SMD = 0.34; 95% CI = 0.10, 0.58;P= .006) also resulted in beneficial effects. No significant effect was observed for interventions that involved support services over 9 studies (SMD = 0.09 [95% CI = -0.04, 0.21];I(2)= 0%;P= .16). The included studies provide evidence that rehabilitation interventions may be effective in improving social participation after stroke, especially if exercise is one of the components. © The Author(s) 2015.

Non-absorbable disaccharides versus placebo/no intervention and lactulose versus lactitol for the prevention and treatment of hepatic encephalopathy in people with cirrhosis

DEFF Research Database (Denmark)

Gluud, Lise Lotte; Vilstrup, Hendrik; Morgan, Marsha Y

2016-01-01

BACKGROUND: Non-absorbable disaccharides (lactulose and lactitol) are recommended as first-line treatment for hepatic encephalopathy. The previous (second) version of this review included 10 randomised clinical trials (RCTs) evaluating non-absorbable disaccharides versus placebo/no intervention...... and eight RCTs evaluating lactulose versus lactitol for people with cirrhosis and hepatic encephalopathy. The review found no evidence to either support or refute the use of the non-absorbable disaccharides and no differences between lactulose versus lactitol. OBJECTIVES: To assess the beneficial...... and harmful effects of i) non-absorbable disaccharides versus placebo/no intervention and ii) lactulose versus lactitol in people with cirrhosis and hepatic encephalopathy. SEARCH METHODS: We carried out electronic searches of the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central...

Interventions to reduce weight gain in schizophrenia.

Science.gov (United States)

Faulkner, G; Cohn, T; Remington, G

2007-01-24

Weight gain is common for people with schizophrenia and this has serious implications for health and well being. To determine the effects of both pharmacological (excluding medication switching) and non pharmacological strategies for reducing or preventing weight gain in people with schizophrenia. We searched key databases and the Cochrane Schizophrenia Group's trials register (April 2006), reference sections within relevant papers, hand searched key journals, and contacted the first author of each relevant study and other experts to collect further information. We included all clinical randomised controlled trials comparing any pharmacological or non pharmacological intervention for weight gain (diet and exercise counselling) with standard care or other treatments for people with schizophrenia or schizophrenia-like illnesses. We reliably selected, quality assessed and extracted data from studies. As weight is a continuous outcome measurement, weighted mean differences (WMD) of the change from baseline were calculated. The primary outcome measure was weight loss. Twenty-three randomised controlled trials met the inclusion criteria for this review. Five trials assessed a cognitive/behavioural intervention and eighteen assessed a pharmacological adjunct. In terms of prevention, two cognitive/behavioural trials showed significant treatment effect (mean weight change) at end of treatment (n=104, 2 RCTs, WMD -3.38 kg CI -4.2 to -2.0). Pharmacological adjunct treatments were significant with a modest prevention of weight gain (n=274, 6 RCTs, WMD - 1.16 kg CI -1.9 to -0.4). In terms of treatments for weight loss, we found significantly greater weight reduction in the cognitive behavioural intervention group (n=129, 3 RCTs, WMD -1.69 kg CI -2.8 to -0.6) compared with standard care. Modest weight loss can be achieved with selective pharmacological and non pharmacological interventions. However, interpretation is limited by the small number of studies, small sample size

Evidence-based interventions for reading and language difficulties: creating a virtuous circle.

Science.gov (United States)

Snowling, Margaret J; Hulme, Charles

2011-03-01

BACKGROUND. Children may experience two very different forms of reading problem: decoding difficulties (dyslexia) and reading comprehension difficulties. Decoding difficulties appear to be caused by problems with phonological (speech sound) processing. Reading comprehension difficulties in contrast appear to be caused by problems with 'higher level' language difficulties including problems with semantics (including deficient knowledge of word meanings) and grammar (knowledge of morphology and syntax). AIMS. We review evidence concerning the nature, causes of, and treatments for children's reading difficulties. We argue that any well-founded educational intervention must be based on a sound theory of the causes of a particular form of learning difficulty, which in turn must be based on an understanding of how a given skill is learned by typically developing children. Such theoretically motivated interventions should in turn be evaluated in randomized controlled trials (RCTs) to establish whether they are effective, and for whom. RESULTS. There is now considerable evidence showing that phonologically based interventions are effective in ameliorating children's word level decoding difficulties, and a smaller evidence base showing that reading and oral language (OL) comprehension difficulties can be ameliorated by suitable interventions to boost vocabulary and broader OL skills. CONCLUSIONS. The process of developing theories about the origins of children's educational difficulties and evaluating theoretically motivated treatments in RCTs, produces a 'virtuous circle' whereby theory informs practice, and the evaluation of effective interventions in turn feeds back to inform and refine theories about the nature and causes of children's reading and language difficulties. ©2010 The British Psychological Society.

Family-Based Interventions in Preventing Children and Adolescents from Using Tobacco: A Systematic Review and Meta-Analysis.

Science.gov (United States)

Thomas, Roger E; Baker, Philip R A; Thomas, Bennett C

2016-07-01

Tobacco is the main preventable cause of death and disease worldwide. Adolescent smoking is increasing in many countries with poorer countries following the earlier experiences of affluent countries. Preventing adolescents from starting smoking is crucial to decreasing tobacco-related illness. To assess effectiveness of family-based interventions alone and combined with school-based interventions to prevent children and adolescents from initiating tobacco use. Fourteen bibliographic databases and the Internet, journals hand-searched, and experts consulted. Randomized controlled trials (RCTs) with children or adolescents and families, interventions to prevent starting tobacco use, and follow-up ≥6 months. Abstracts/titles independently assessed and data independently entered by 2 authors. Risk of bias was assessed with the Cochrane Risk-of-Bias tool. Twenty-seven RCTs were included. Nine trials of never-smokers compared with a control provided data for meta-analysis. Family intervention trials had significantly fewer students who started smoking. Meta-analysis of 2 RCTs of combined family and school interventions compared with school only, showed additional significant benefit. The common feature of effective high-intensity interventions was encouraging authoritative parenting. Only 14 RCTs provided data for meta-analysis (approximately a third of participants). Of the 13 RCTs that did not provide data for meta-analysis 8 compared a family intervention with no intervention and 1 reported significant effects, and 5 compared a family combined with school intervention with a school intervention only and none reported additional significant effects. There is moderate-quality evidence that family-based interventions prevent children and adolescents from starting to smoke. Copyright © 2016 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Intervention Now to Eliminate Repeat Unintended Pregnancy in Teenagers (INTERUPT): a systematic review of intervention effectiveness and cost-effectiveness, and qualitative and realist synthesis of implementation factors and user engagement.

Science.gov (United States)

Aslam, Rabeea'h W; Hendry, Maggie; Booth, Andrew; Carter, Ben; Charles, Joanna M; Craine, Noel; Edwards, Rhiannon Tudor; Noyes, Jane; Ntambwe, Lupetu Ives; Pasterfield, Diana; Rycroft-Malone, Jo; Williams, Nefyn; Whitaker, Rhiannon

2017-08-15

Unintended repeat conceptions can result in emotional, psychological and educational harm to young women, often with enduring implications for their life chances. This study aimed to identify which young women are at the greatest risk of repeat unintended pregnancies; which interventions are effective and cost-effective; and what are the barriers to and facilitators for the uptake of these interventions. We conducted a mixed-methods systematic review which included meta-analysis, framework synthesis and application of realist principles, with stakeholder input and service user feedback to address this. We searched 20 electronic databases, including MEDLINE, Excerpta Medica database, Applied Social Sciences Index and Abstracts and Research Papers in Economics, to cover a broad range of health, social science, health economics and grey literature sources. Searches were conducted between May 2013 and June 2014 and updated in August 2015. Twelve randomised controlled trials (RCTs), two quasi-RCTs, 10 qualitative studies and 53 other quantitative studies were identified. The RCTs evaluated psychosocial interventions and an emergency contraception programme. The primary outcome was repeat conception rate: the event rate was 132 of 308 (43%) in the intervention group versus 140 of 289 (48%) for the control group, with a non-significant risk ratio (RR) of 0.92 [95% confidence interval (CI) 0.78-1.08]. Four studies reported subsequent birth rates: 29 of 237 (12%) events for the intervention arm versus 46 out of 224 (21%) for the control arm, with an RR of 0.60 (95% CI 0.39-0.93). Many repeat conceptions occurred in the context of poverty, low expectations and aspirations and negligible opportunities. Qualitative and realist evidence highlighted the importance of context, motivation, future planning and giving young women a central and active role in the development of new interventions. Little or no evidence for the effectiveness or cost-effectiveness of any of the

Aromatherapy for the Treatment of Patients with Behavioral and Psychological Symptoms of Dementia: A Descriptive Analysis of RCTs.

Science.gov (United States)

Press-Sandler, Olga; Freud, Tamar; Volkov, Ilya; Peleg, Roni; Press, Yan

2016-06-01

Behavioral and psychological symptoms of dementia (BPSD) are a common problem among patients with dementia. This problem is usually treated by drugs, but they have limited efficacy and often cause adverse effects. Aromatherapy is a nonpharmacologic treatment that is simple to use and devoid of significant adverse effects. To review the literature on the effectiveness of aromatherapy treatment in patients with BPSD. A descriptive analysis of randomized clinical trials (RCTs) published in the English-language literature and cited in PubMed. Eleven articles on RCTs were found, of which 1 had fewer than 10 participants, 2 were mistakenly presented as RCTs, and another did not report treatment for BPSD. In all, 7 articles with 417 participants total (range, 15-114) were reviewed. The mean age in all studies was greater than 69 years (range, 69-85 years), and the percentage of women was 55% (range, 50%-57%). The intervention period ranged from 10 days to 12 weeks. Two studies used Melissa oil and 5 others used lavender oil. The studies described different methods of administration for the oils, including spraying and rubbing over various body organs. The duration of treatment differed among the studies. In 3 studies the investigators concluded that the treatment was not effective and in 3 that it was effective; in 1 study no clear conclusion could be drawn. The difference between positive and negative studies was not explained by differences in the study population, the type of oil, or the duration of treatment. The significant difference apparently stems from the method of administration. When the oil was applied close to the olfactory system the outcome was positive. A study should be designed to assess the effect of the site of application of aromatherapy.

Non-pharmacological interventions for preventing job loss in workers with inflammatory arthritis.

Science.gov (United States)

Hoving, Jan L; Lacaille, Diane; Urquhart, Donna M; Hannu, Timo J; Sluiter, Judith K; Frings-Dresen, Monique H W

2014-11-06

Work participation of patients with inflammatory arthritis (IA) is important not only economically but also for physical and psychological health. There is no Cochrane Review to date on studies of non-pharmacological interventions specifically aimed at preventing job loss in people with IA. To assess the effects of non-pharmacological interventions that aim to prevent job loss, work absenteeism or improve work functioning for employees with IA (rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), other spondylarthritis (SpA) or IA associated with connective tissue diseases, such as Systemic Lupus Erythematosus (SLE)). We searched the following databases from inception up to 30 April 2014; The Cochrane Library (including Cochrane Central Register of Controlled Trials, i.e. CENTRAL and DARE), MEDLINE (PubMed), EMBASE (Embase.com), CINAHL (EbSCOhost), ClinicalTrials.gov and PsycINFO (ProQuest). We did not impose language restrictions in the search. We included randomised controlled trials (RCTs) that evaluated interventions aimed at preventing job loss in adults of working age (18 to 65 years) diagnosed with IA, including RA, AS, PsA, SpA or other types of IA. Primary outcomes were job loss and sickness absenteeism and the secondary outcome was work functioning. Two review authors independently selected trials for inclusion, extracted data and assessed risk of bias in the included RCTs. We included three RCTs with a total of 414 participants at risk of job loss. The majority of participants had IA, most with RA and to a lesser degree AS. The interventions aimed to prevent job loss and improve work functioning in several ways: firstly by evaluating work changes or adaptations and secondly by providing any person-directed interventions including vocational counselling, advice or education. Interventions directly targeted at the work environment were minimal and included workplace visits (one trial) or any actions by an occupational

The effectiveness of physical and organisational ergonomic interventions on low back pain and neck pain: A systematic review

NARCIS (Netherlands)

Driessen, M.T.; Proper, K.I.; Tulder, M.W. van; Anema, J.R.; Bongers, P.M.; Beek, A.J. van der

2010-01-01

Ergonomic interventions (physical and organisational) areused to prevent or reduce low back pain (LBP) and neck pain among workers. We conducted a systematic review of randomised controlled trials (RCTs) on the effectiveness of ergonomic interventions. A total of 10 RCTs met the inclusion criteria.

Is sustained virological response a marker of treatment efficacy in patients with chronic hepatitis C viral infection with no response or relapse to previous antiviral intervention?

DEFF Research Database (Denmark)

Gurusamy, Kurinchi S; Wilson, Edward; Koretz, Ronald L

2013-01-01

Randomised clinical trials (RCTs) of antiviral interventions in patients with chronic hepatitis C virus (HCV) infection use sustained virological response (SVR) as the main outcome. There is sparse information on long-term mortality from RCTs.......Randomised clinical trials (RCTs) of antiviral interventions in patients with chronic hepatitis C virus (HCV) infection use sustained virological response (SVR) as the main outcome. There is sparse information on long-term mortality from RCTs....

Pharmacological interventions for unilateral spatial neglect after stroke.

Science.gov (United States)

Luvizutto, Gustavo José; Bazan, Rodrigo; Braga, Gabriel Pereira; Resende, Luiz Antônio de Lima; Bazan, Silméia Garcia Z; El Dib, Regina

2015-11-06

Unilateral spatial neglect (USN) is characterized by the inability to report or respond to people or objects presented on the side contralateral to the lesioned side of the brain and has been associated with poor functional outcomes and long stays in hospitals and rehabilitation centers. Pharmacological interventions (medical interventions only, use of drugs to improve the health condition), such as dopamine and noradrenergic agonists or pro-cholinergic treatment, have been used in people affected by USN after stroke, and effects of these treatments could provide new insights for health professionals and policy makers. To evaluate the effectiveness and safety of pharmacological interventions for USN after stroke. We searched the Cochrane Stroke Group Trials Register (April 2015), the Cochrane Central Register of Controlled Trials (April 2015), MEDLINE (1946 to April 2015), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to April 2015), EMBASE (1980 to April 2015), PsycINFO (1806 to April 2015) and Latin American Caribbean Health Sciences Literature (LILACS) (1982 to April 2015). We also searched trials and research registers, screened reference lists, and contacted study authors and pharmaceutical companies (April 2015). We included randomized controlled trials (RCTs) and quasi-randomized controlled trials (quasi-RCTs) of pharmacological interventions for USN after stroke. Two review authors independently assessed risk of bias in the included studies and extracted data. We included in the review two studies with a total of 30 randomly assigned participants. We rated the quality of the evidence as very low as the result of study limitations, small numbers of events, and small sample sizes, with imprecision in the confidence interval (CI). We were not able to perform meta-analysis because of heterogeneity related to the different interventions evaluated between included studies. Very low-quality evidence from one trial (20 participants

Non-pharmacological interventions for caregivers of stroke survivors.

Science.gov (United States)

Legg, Lynn A; Quinn, Terry J; Mahmood, Fahd; Weir, Christopher J; Tierney, Jayne; Stott, David J; Smith, Lorraine N; Langhorne, Peter

2011-10-05

A substantial component of care is provided to stroke survivors by informal caregivers. However, providing such care is often a new and challenging experience and has been linked to a number of adverse outcomes. A range of interventions targeted towards stroke survivors and their family or other informal caregivers have been tested in randomised controlled trials (RCTs).  To evaluate the effect of interventions targeted towards informal caregivers of stroke survivors or targeted towards informal caregivers and the care recipient (the stroke survivor). We searched the Cochrane Stroke Group Trials Register (March 2011), CENTRAL (The Cochrane Library Issue 2010, Issue 4), MEDLINE (1950 to August 2010), EMBASE (1980 to December 2010), CINAHL (1982 to August 2010), AMED (1985 to August 2010), PsycINFO (1967 to August 2010) and 11 additional databases. In an effort to identify further published, unpublished and ongoing studies, we searched conference proceedings and trials registers, scanned reference lists of relevant articles and contacted authors and researchers. There were no language restrictions. We included RCTs if they evaluated the effect of non-pharmacological interventions (compared with no care or routine care) on informal caregivers of stroke survivors. We included trials of interventions delivered to stroke survivors and informal caregivers only if the stroke survivor and informal caregiver were randomised as a dyad. We excluded studies which included stroke survivors and caregivers if the stroke survivors were the primary target of the intervention. Two review authors selected studies for inclusion, independently extracted data and assessed methodological quality. We sought original data from trialists. We categorised interventions into three groups: support and information, teaching procedural knowledge/vocational training type interventions, and psycho-educational type interventions. The primary outcome was caregivers' stress or strain. We resolved

Game-based digital interventions for depression therapy: a systematic review and meta-analysis.

Science.gov (United States)

Li, Jinhui; Theng, Yin-Leng; Foo, Schubert

2014-08-01

The aim of this study was to review the existing literature on game-based digital interventions for depression systematically and examine their effectiveness through a meta-analysis of randomized controlled trials (RCTs). Database searching was conducted using specific search terms and inclusion criteria. A standard meta-analysis was also conducted of available RCT studies with a random effects model. The standard mean difference (Cohen's d) was used to calculate the effect size of each study. Nineteen studies were included in the review, and 10 RCTs (eight studies) were included in the meta-analysis. Four types of game interventions-psycho-education and training, virtual reality exposure therapy, exercising, and entertainment-were identified, with various types of support delivered and populations targeted. The meta-analysis revealed a moderate effect size of the game interventions for depression therapy at posttreatment (d=-0.47 [95% CI -0.69 to -0.24]). A subgroup analysis showed that interventions based on psycho-education and training had a smaller effect than those based on the other forms, and that self-help interventions yielded better outcomes than supported interventions. A higher effect was achieved when a waiting list was used as the control. The review and meta-analysis support the effectiveness of game-based digital interventions for depression. More large-scale, high-quality RCT studies with sufficient long-term data for treatment evaluation are needed.

Mechanism evaluation of a lifestyle intervention for patients with musculoskeletal pain who are overweight or obese: protocol for a causal mediation analysis.

Science.gov (United States)

Lee, Hopin; Wiggers, John; Kamper, Steven J; Williams, Amanda; O'Brien, Kate M; Hodder, Rebecca K; Wolfenden, Luke; Yoong, Sze Lin; Campbell, Elizabeth; Haskins, Robin; Robson, Emma K; McAuley, James H; Williams, Christopher M

2017-07-03

Low back pain (LBP) and knee osteoarthritis (OA) are highly prevalent and disabling conditions that cause societal and economic impact worldwide. Two randomised controlled trials (RCTs) will evaluate the effectiveness of a multicomponent lifestyle intervention for patients with LBP and knee OA who are overweight or obese. The key targets of this intervention are to improve physical activity, modify diet and correct pain beliefs. These factors may explain how a lifestyle intervention exerts its effects on key patient-relevant outcomes: pain, disability and quality of life. The aim of this protocol is to describe a planned analysis of a mechanism evaluation for a lifestyle intervention for overweight or obese patients with LBP and knee OA. Causal mediation analyses of 2 two-armed RCTs. Both trials are part of a cohort-multiple RCT, embedded in routine health service delivery. In each respective trial, 160 patients with LBP and 120 patients with knee OA waiting for orthopaedic consultation will be randomised to a lifestyle intervention, or to remain part of the original cohort. The intervention consists of education and advice about the benefits of weight loss and physical activity, and the Australian New South Wales Get Healthy Service. All outcome measures including patient characteristics, primary and alternative mediators, outcomes, and potential confounders will be measured at baseline (T0). The primary mediator, weight, will be measured at 6 months post randomisation; alternative mediators including diet, physical activity and pain beliefs will be measured at 6 weeks post randomisation. All outcomes (pain, disability and quality of life) will be measured at 6 months post randomisation. Data will be analysed using causal mediation analysis with sensitivity analyses for sequential ignorability. All mediation models were specified a priori before completing data collection and without prior knowledge about the effectiveness of the intervention. The study is

Interventions to reduce weight gain in schizophrenia

Science.gov (United States)

Faulkner, Guy; Cohn, Tony; Remington, Gary

2014-01-01

Background Weight gain is common for people with schizophrenia and this has serious implications for health and well being. Objectives To determine the effects of both pharmacological (excluding medication switching) and non pharmacological strategies for reducing or preventing weight gain in people with schizophrenia. Search methods We searched key databases and the Cochrane Schizophrenia Group’s trials register (April 2006), reference sections within relevant papers, hand searched key journals, and contacted the first author of each relevant study and other experts to collect further information. Selection criteria We included all clinical randomised controlled trials comparing any pharmacological or non pharmacological intervention for weight gain (diet and exercise counselling) with standard care or other treatments for people with schizophrenia or schizophrenia-like illnesses. Data collection and analysis We reliably selected, quality assessed and extracted data from studies. As weight is a continuous outcome measurement, weighted mean differences (WMD) of the change from baseline were calculated. The primary outcome measure was weight loss. Main results Twenty-three randomised controlled trials met the inclusion criteria for this review. Five trials assessed a cognitive/behavioural intervention and eighteen assessed a pharmacological adjunct. In terms of prevention, two cognitive/behavioural trials showed significant treatment effect (mean weight change) at end of treatment (n=104, 2 RCTs, WMD −3.38 kg CI −4.2 to −2.0). Pharmacological adjunct treatments were significant with a modest prevention of weight gain (n=274, 6 RCTs, WMD − 1.16 kg CI −1.9 to −0.4). In terms of treatments for weight loss, we found significantly greater weight reduction in the cognitive behavioural intervention group (n=129, 3 RCTs, WMD −1.69 kg CI −2.8 to −0.6) compared with standard care. Authors’ conclusions Modest weight loss can be achieved with selective

The quality of reporting of RCTs used within a postoperative pain management meta-analysis, using the CONSORT statement

Directory of Open Access Journals (Sweden)

Borg Debono Victoria

2012-07-01

Full Text Available Abstract Background Randomized controlled trials (RCTs are routinely used in systematic reviews and meta-analyses that help inform healthcare and policy decision making. The proper reporting of RCTs is important because it acts as a proxy for health care providers and researchers to appraise the quality of the methodology, conduct and analysis of an RCT. The aims of this study are to analyse the overall quality of reporting in 23 RCTs that were used in a meta-analysis by assessing 3 key methodological items, and to determine factors associated with high quality of reporting. It is hypothesized that studies with larger sample sizes, that have funding reported, that are published in journals with a higher impact factor and that are in journals that have adopted or endorsed the CONSORT statement will be associated with better overall quality of reporting and reporting of key methodological items. Methods We systematically reviewed RCTs used within an anesthesiology related post-operative pain management meta-analysis. We included all of the 23 RCTs used, all of which were parallel design that addressed the use of femoral nerve block in improving outcomes after total knee arthroplasty. Data abstraction was done independently by two reviewers. The two main outcomes were: 1 15 point overall quality of reporting score (OQRS based on the Consolidated Standards for Reporting Trials (CONSORT and 2 3 point key methodological item score (KMIS based on allocation concealment, blinding and intention-to-treat analysis. Results Twenty-three RCTs were included. The median OQRS was 9.0 (Interquartile Range = 3. A multivariable regression analysis did not show any significant association between OQRS or KMIS and our four predictor variables hypothesized to improve reporting. The direction and magnitude of our results when compared to similar studies suggest that the sample size and impact factor are associated with improved key methodological item reporting

Fat type in phytosterol products influence their cholesterol-lowering potential: A systematic review and meta-analysis of RCTs.

Science.gov (United States)

Ferguson, Jessica J A; Stojanovski, Elizabeth; MacDonald-Wicks, Lesley; Garg, Manohar L

2016-10-01

The most common form of phytosterol (PS) fortified foods are fat spreads and dairy products. The predominant fats used are soybean/sunflower (SS) or rapeseed/canola (RC) oils and animal fat (D) in dairy products. This review aimed to investigate whether the carrier fat is a determinant of the hypocholesterolaemic effects of PS fortified foods. Databases were searched using relevant keywords and published RCTs from 1990 investigating the effects of dietary PS intervention (≥1.5g per day) on total cholesterol and LDL-C were included. After methodological quality assessment and data extraction, a total of 32 RCTs (RC, n=15; SS, n=9; D, n=8) were included. As expected, all fat groups significantly reduced TC and LDL-C (p<0.01). When compared across different carrier fats, RC as the main carrier fat, reduced LDL-C significantly more than the SS spreads (p=0.01). Therefore, a combination of monounsaturated fatty acid rich spread with adequate amounts of omega-3 fatty acids (as evident in RC spreads) may be the superior carrier fat for the delivery of PS for optimal blood cholesterol-lowering. The findings of this research provide useful evidence for optimising the hypocholesterolaemic effects of PS and support further investigation into the possible mechanisms behind these findings. Copyright © 2016 Elsevier B.V. All rights reserved.

Systematic review of universal and targeted workplace interventions for depression.

Science.gov (United States)

Wan Mohd Yunus, Wan Mohd Azam; Musiat, Peter; Brown, June S L

2018-01-01

Depression is increasingly being recognised as a significant mental health problem in the workplace contributing to productivity loss and economic burden to organisations. This paper reviews recently published randomised controlled trials (RCTs) of universal and targeted interventions to reduce depression in the workplace. Studies were identified through searches of EMBASE, MEDLINE/PubMed, PsycINFO, PsycARTICLES Full Text, and Global Health and Social Policy and Practice databases. Studies were included if they included an RCT of a workplace intervention for employees targeting depression as the primary outcome. Twenty-two published RCTs investigating interventions utilising various therapeutic approaches were identified. The cognitive behavioural therapy (CBT) approach is the most frequently used in the workplace, while interventions that combine different therapeutic approaches showed the most promising results. A universal intervention in the workplace that combines CBT and coping flexibility recorded the highest effect size (d=1.45 at 4 months' follow-up). Most interventions were delivered in group format and showed low attrition rates compared with other delivery formats. Although all studies reviewed were RCTs, the quality of reporting is low. Interventions using different therapeutic approaches with different modes of delivery have been used. Most of these interventions were shown to reduce depression levels among employees in the workplace, particularly those that combine more than one therapeutic approaches. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

Science.gov (United States)

Poston, Lucilla; Briley, Annette L; Barr, Suzanne; Bell, Ruth; Croker, Helen; Coxon, Kirstie; Essex, Holly N; Hunt, Claire; Hayes, Louise; Howard, Louise M; Khazaezadeh, Nina; Kinnunen, Tarja; Nelson, Scott M; Oteng-Ntim, Eugene; Robson, Stephen C; Sattar, Naveed; Seed, Paul T; Wardle, Jane; Sanders, Thomas A B; Sandall, Jane

2013-07-15

Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity. We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2). Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery. This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT. ISRCTN89971375.

[Individual, community, regulatory, and systemic approaches to tobacco control interventions].

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Gorini, Giuseppe

2011-01-01

During the 60s and the 70s strategies for decreasing initiation or quitting have been developed, in order to find those with high success rates. Unfortunately, interventions with an individual approach involved few smokers, so their impact in decreasing smoking prevalence was limited. The socio-ecological model offers a theoretical framework to community interventions for smoking cessation developed during the 80s, in which smoking was considered not only an individual, but also a social problem. In the 80s and the 90s smoking cessation community trials were developed, such as the Community Intervention Trial for Smoking Cessation (COMMIT). Afterwards, policy interventions (price policy; smoking bans in public places; advertising bans; bans of sales to minors) were developed, such as the American Stop Smoking Intervention Study for Cancer Prevention (ASSIST). California has been the first State all over the world to develop a comprehensive Tobacco Control Program in 1988, becoming the place for an ever-conducted natural experiment. All policy interventions in tobacco control have been finally grouped together in the World Health Organization - Framework Convention on Tobacco Control (WHO-FCTC), the first Public Health Treaty. Study designs have changed, according to the individual, community, or regulatory approaches: the classical randomized controlled trials (RCTs), in which the sampling unit is the individual, have been carried out for the evaluation of smoking cessation treatments, whereas cluster RCTs, in which the sampling unit is the community, have been conducted for evaluating community interventions, such as COMMIT. Finally, quasi-experimental studies (before/after study; prospective cohorts, both with a control group), in which the observational unit is a State, have been used for evaluating tobacco control policies, such as ASSIST and the International Tobacco Control Policy Evaluation Project. Although the successes of the last 20 years, tobacco

Balancing Opposing Forces—A Nested Process Evaluation Study Protocol for a Stepped Wedge Designed Cluster Randomized Controlled Trial of an Experience Based Codesign Intervention

Directory of Open Access Journals (Sweden)

Victoria Jane Palmer

2016-10-01

Full Text Available Background: Process evaluations are essential to understand the contextual, relational, and organizational and system factors of complex interventions. The guidance for developing process evaluations for randomized controlled trials (RCTs has until recently however, been fairly limited. Method/Design: A nested process evaluation (NPE was designed and embedded across all stages of a stepped wedge cluster RCT called the CORE study. The aim of the CORE study is to test the effectiveness of an experience-based codesign methodology for improving psychosocial recovery outcomes for people living with severe mental illness (service users. Process evaluation data collection combines qualitative and quantitative methods with four aims: (1 to describe organizational characteristics, service models, policy contexts, and government reforms and examine the interaction of these with the intervention; (2 to understand how the codesign intervention works, the cluster variability in implementation, and if the intervention is or is not sustained in different settings; (3 to assist in the interpretation of the primary and secondary outcomes and determine if the causal assumptions underpinning the codesign interventions are accurate; and (4 to determine the impact of a purposefully designed engagement model on the broader study retention and knowledge transfer in the trial. Discussion: Process evaluations require prespecified study protocols but finding a balance between their iterative nature and the structure offered by protocol development is an important step forward. Taking this step will advance the role of qualitative research within trials research and enable more focused data collection to occur at strategic points within studies.

Effect of Low-Fat vs. Other Diet Interventions on Long-Term Weight Change in Adults: A Systematic Review and Meta-Analysis

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Tobias, Deirdre K.; Chen, Mu; Manson, JoAnn E.; Ludwig, David S.; Willett, Walter; Hu, Frank B.

2015-01-01

Background: The effectiveness of low-fat diets for long-term weight loss has been debated for decades, with dozens of randomized trials (RCTs) and recent reviews giving mixed results. Methods: We conducted a random effects meta-analysis of RCTs to estimate the long-term effect of low-fat vs. higher fat dietary interventions on weight loss. Our search included RCTs conducted in adult populations reporting weight change outcomes at ≥1 year, comparing low-fat with higher fat interventions, publi...

Psychological and support interventions to reduce levels of stress, anxiety or depression on women's subsequent pregnancy with a history of miscarriage: an empty systematic review.

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San Lazaro Campillo, Indra; Meaney, Sarah; McNamara, Karen; O'Donoghue, Keelin

2017-09-07

The aim of this systematic review was to assess the effect of interventions to reduce stress in pregnant women with a history of miscarriage. A systematic review of randomised controlled trials (RCTs). A total of 13 medical, psychological and social electronic databases were searched from January 1995 to April 2016 including PUBMED, CENTRAL, Web of Science and EMBASE. This review focused on women in their subsequent pregnancy following miscarriage. All published RCTs which assessed the effect of non-medical interventions such as counselling or support interventions on psychological and mental health outcomes such as stress, anxiety or depression when compared with a control group were included. Stress, anxiety or depression had to be measured at least preintervention and postintervention. This systematic review found no RCT which met our initial inclusion criteria. Of the 4140 titles screened, 17 RCTs were identified. All of them were excluded. One RCT, which implemented a caring-based intervention, included pregnant women in their subsequent pregnancy; however, miscarriage was analysed as a composite variable among other pregnancy losses such as stillbirth and neonatal death. Levels of perceived stress were measured by four RCTs. Different types of non-medical interventions, time of follow-up and small sample sizes were found. Cohort studies and RCTs in non-pregnant women suggest that support and psychological interventions may improve pregnant women's psychological well-being after miscarriage. This improvement may reduce adverse pregnancy-related outcomes in subsequent pregnancies. However, this review found no RCTs which met our criteria. There is a need for targeted RCTs that can provide reliable and conclusive results to determine effective interventions for this vulnerable group. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly

Adapting, piloting and evaluating complex public health interventions: lessons learned from the Nurse-Family Partnership in Canadian public health settings

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S. M. Jack

2015-01-01

Full Text Available Introduction: The Nurse-Family Partnership (NFP is a home-visit program for young and first-time, socially and economically disadvantaged mothers. Evidence from three United States randomized controlled trials (RCTs on the effectiveness of this intervention at improving pregnancy outcomes, improving child health and development, and increasing maternal economic self-sufficiency is robust. However, the effectiveness of the NFP in Canada, with its different health and social care context, needs to be determined. The purpose of this article is to describe the complex process for moving the NFP from the research arena to full implementation in Canada. Methods: This process of evaluation in Canada includes (1 adapting the intervention; (2 piloting the intervention in small-scale feasibility and acceptability studies; and (3 conducting an RCT and process evaluation through a study called the British Columbia Healthy Connections Project (BCHCP. This large-scale evaluation also creates an opportunity to expand the NFP evidence base by conducting an additional study to examine potential biological mechanisms linking intervention and behavioural outcomes in children. Results: Adaptation of the NFP home-visit materials is a continuous process. A pilot project determined that it was feasible to enrol eligible women into the NFP. This pilot also determined that, in Canada, it was most appropriate for public health agencies to implement the NFP and for public health nurses to deliver the intervention. Finally, the pilot showed that this intensive home-visit program was acceptable to clients, their family members and health care providers. Through the BCHCP, the next steps—the RCT and process evaluation—are currently underway. The BCHCP will also set the foundation for long-term evaluation of key public health outcomes in a highly vulnerable population of families.

A clinical nurse specialist-led intervention to enhance medication adherence using the plan-do-check-act cycle for continuous self-improvement.

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Russell, Cynthia L

2010-01-01

A clinical nurse specialist-led intervention to improve medication adherence in chronically ill adults using renal transplant recipients as an exemplar population is proposed. Meta-analyses and systematic reviews of chronically ill and transplant patients indicate that patient-specific characteristics not only are poor and inconsistent predictors for medication nonadherence but also are not amenable to intervention. Adherence has not meaningfully improved, despite meta-analyses and systematic narrative reviews of randomized controlled trials (RCTs) dealing with medication nonadherence in acutely and chronically ill persons and RCTs dealing with transplant patients. Interventions with a superior potential to enhance medication adherence must be developed. Use of a clinical nurse specialist-led continuous self-improvement intervention with adult renal transplant recipients is proposed. Continuous self-improvement focuses on improving personal systems thinking and behavior using the plan-do-check-act process. Electronic medication monitoring reports, one of several objective measures of medication adherence, are used by the clinician to provide patient feedback during the check process on medication-taking patterns. Continuous self-improvement as an intervention holds promise in supporting patient self-management and diminishing the blame that clinicians place on patients for medication nonadherence. Using an objective measure of medication adherence such as an electronic monitoring report fosters collaborative patient-clinician discussions of daily medication-taking patterns. Through collaboration, ideas for improving medication taking can be explored. Changes can be followed and evaluated for effectiveness through the continuous self-improvement process. Future studies should include RCTs comparing educational and/or behavioral interventions to improve medication adherence.

Effect of preoperative smoking cessation interventions on postoperative complications and smoking cessation

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Thomsen, T; Tønnesen, H; Møller, A M

2009-01-01

BACKGROUND: The aim of this study was to examine the effect of preoperative smoking cessation interventions on postoperative complications and smoking cessation itself. METHODS: Relevant databases were searched for randomized controlled trials (RCTs) of preoperative smoking cessation interventions....... Trial inclusion, risk of bias assessment and data extraction were performed by two authors. Risk ratios for the above outcomes were calculated and pooled effects estimated using the fixed-effect method. RESULTS: Eleven RCTs were included containing 1194 patients. Smoking interventions were intensive......, medium intensity and less intensive. Follow-up for postoperative complications was 30 days. For smoking cessation it was from the day of surgery to 12 months thereafter. Overall, the interventions significantly reduced the occurrence of complications (pooled risk ratio 0.56 (95 per cent confidence...

Systematic review of stigma reducing interventions for African/Black diasporic women.

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Loutfy, Mona; Tharao, Wangari; Logie, Carmen; Aden, Muna A; Chambers, Lori A; Wu, Wei; Abdelmaseh, Marym; Calzavara, Liviana

2015-01-01

Literature indicates that racism, sexism, homophobia and HIV-related stigma have adverse impacts on health, well-being, and quality of life among HIV-positive women of African descent (African/Black diaspora). However, limited evidence exists on the effectiveness of interventions aimed at reducing stigma tailored for these women. This study systematically reviewed randomized controlled trials (RCTs), non-randomized observational and quasi-experimental studies evaluating the effectiveness of interventions aimed at reducing stigma experienced by this population. The Cochrane methodology was used to develop a search strategy in consultation with a librarian scientist. Databases searched included the Cochrane Library, Ovid EMBASE, PsycInfo, and 10 others. Two reviewers independently assessed the studies for potential relevance and conducted the Cochrane grading of RCTs to assess risk of bias and the Newcastle-Ottawa scale to assess the quality of non-randomized studies. Eligible papers were selected if they employed an intervention design with African/Black diasporic women living with HIV as the target population and had a primary outcome of stigma reduction. Of the five studies that met all of the eligibility criteria, four demonstrated the effectiveness of interventions in reducing HIV-related stigma. Only two of the five studies were designed specifically for HIV-positive African/Black diasporic women. Limitations included the absence of interventions addressing other forms of stigma and discrimination (e.g. gender discrimination, racism, heterosexism). Our findings suggest that there are limited interventions designed to address multiple forms of stigma, including gender and racial discrimination, experienced by HIV-positive African/Black diasporic women.

Deficiencies of effectiveness of intervention studies in veterinary medicine: a cross-sectional survey of ten leading veterinary and medical journals

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Meursinge Reynders, Reint

2016-01-01

The validity of studies that assess the effectiveness of an intervention (EoI) depends on variables such as the type of study design, the quality of their methodology, and the participants enrolled. Five leading veterinary journals and 5 leading human medical journals were hand-searched for EoI studies for the year 2013. We assessed (1) the prevalence of randomized controlled trials (RCTs) among EoI studies, (2) the type of participants enrolled, and (3) the methodological quality of the selected studies. Of 1707 eligible articles, 590 were EoI articles and 435 RCTs. Random allocation to the intervention was performed in 52% (114/219; 95%CI:45.2–58.8%) of veterinary EoI articles, against 87% (321/371; 82.5–89.7%) of human EoI articles (adjusted OR:9.2; 3.4–24.8). Veterinary RCTs were smaller (median: 26 animals versus 465 humans) and less likely to enroll real patients, compared with human RCTs (OR:331; 45–2441). Only 2% of the veterinary RCTs, versus 77% of the human RCTs, reported power calculations, primary outcomes, random sequence generation, allocation concealment and estimation methods. Currently, internal and external validity of veterinary EoI studies is limited compared to human medical ones. To address these issues, veterinary interventional research needs to improve its methodology, increase the number of published RCTs and enroll real clinical patients. PMID:26835187

Parent-only interventions for childhood overweight or obesity in children aged 5 to 11 years.

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Loveman, Emma; Al-Khudairy, Lena; Johnson, Rebecca E; Robertson, Wendy; Colquitt, Jill L; Mead, Emma L; Ells, Louisa J; Metzendorf, Maria-Inti; Rees, Karen

2015-12-21

Child and adolescent overweight and obesity have increased globally, and are associated with short- and long-term health consequences. To assess the efficacy of diet, physical activity and behavioural interventions delivered to parents only for the treatment of overweight and obesity in children aged 5 to 11 years. We performed a systematic literature search of databases including the Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL and LILACS as well trial registers. We checked references of identified trials and systematic reviews. We applied no language restrictions. The date of the last search was March 2015 for all databases. We selected randomised controlled trials (RCTs) of diet, physical activity and behavioural interventions delivered to parents only for treating overweight or obesity in children aged 5 to 11 years. Two review authors independently assessed trials for risk of bias and evaluated overall study quality using the GRADE instrument. Where necessary, we contacted authors for additional information. We included 20 RCTs, including 3057 participants. The number of participants ranged per trial between 15 and 645. Follow-up ranged between 24 weeks and two years. Eighteen trials were parallel RCTs and two were cluster RCTs. Twelve RCTs had two comparisons and eight RCTs had three comparisons. The interventions varied widely; the duration, content, delivery and follow-up of the interventions were heterogeneous. The comparators also differed. This review categorised the comparisons into four groups: parent-only versus parent-child, parent-only versus waiting list controls, parent-only versus minimal contact interventions and parent-only versus other parent-only interventions.Trial quality was generally low with a large proportion of trials rated as high risk of bias on individual risk of bias criteria.In trials comparing a parent-only intervention with a parent-child intervention, the body mass index (BMI) z score change showed a mean difference (MD

Economic evidence for the clinical management of major depressive disorder: a systematic review and quality appraisal of economic evaluations alongside randomised controlled trials.

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Karyotaki, E; Tordrup, D; Buntrock, C; Bertollini, R; Cuijpers, P

2017-10-01

The aim of this systematic review of economic evaluations alongside randomised controlled trials (RCTs) was to provide a comprehensive overview of the evidence concerning cost-effectiveness analyses of common treatment options for major depression. An existing database was used to identify studies reporting cost-effectiveness results from RCTs. This database has been developed by a systematic literature search in the bibliographic databases of PubMed, PsychINFO, Embase and Cochrane library from database inception to December 2014. We evaluated the quality of economic evaluations using a 10-item short version of the Drummond checklist. Results were synthesised narratively. The risk of bias of the included RCTs was assessed, based on the Cochrane risk of bias assessment tool. Fourteen RCTs were included from the 5580 articles screened on titles and abstracts. The methodological quality of the health economic evaluations was relatively high and the majority of the included RCTs had low risk of bias in most of Cochrane items except blinding of participants and personnel. Cognitive behavioural therapy was examined in seven trials as part of a variety of treatment protocols and seems cost-effective compared with pharmacotherapy in the long-term. However cost-effectiveness results for the combination of psychotherapy with pharmacotherapy are conflicting and should be interpreted with caution due to limited comparability between the examined trials. For several treatments, only a single economic evaluation was reported as part of a clinical trial. This was the case for comparisons between different classes of antidepressants, for several types of psychotherapy (behavioural activation, occupational therapy, interpersonal psychotherapy, short-term psychotherapy, psychodynamic psychotherapy, rational emotive behavioural therapy, solution focused therapy), and for transcranial magnetic stimulation v. electroconvulsive therapy. The limited evidence base for these interventions

Improving medication adherence among community-dwelling seniors with cognitive impairment: a systematic review of interventions.

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Kröger, Edeltraut; Tatar, Ovidiu; Vedel, Isabelle; Giguère, Anik M C; Voyer, Philippe; Guillaumie, Laurence; Grégoire, Jean-Pierre; Guénette, Line

2017-08-01

Background Medication non-adherence may lead to poor therapeutic outcomes. Cognitive functions deteriorate with age, contributing to decreased adherence. Interventions have been tested to improve adherence in seniors with cognitive impairment or Alzheimer disease (AD), but high-quality systematic reviews are lacking. It remains unclear which interventions are promising. Objectives We conducted a systematic review to identify, describe, and evaluate interventions aimed at improving medication adherence among seniors with any type of cognitive impairment. Methods Following NICE guidance, databases and websites were searched using combinations of controlled and free vocabulary. All adherence-enhancing interventions and study designs were considered. Studies had to include community dwelling seniors, aged 65 years or older, with cognitive impairment, receiving at least one medication for a chronic condition, and an adherence measure. Study characteristics and methodological quality were assessed. Results We identified 13 interventions, including six RCTs. Two studies were of poor, nine of low/medium and two of high quality. Seven studies had sample sizes below 50 and six interventions focused on adherence to AD medication. Six interventions tested a behavioral, four a medication oriented, two an educational and one a multi-faceted approach. Studies rarely assessed therapeutic outcomes. All but one intervention showed improved adherence. Conclusion Three medium quality studies showed better adherence with patches than with pills for AD treatment. Promising interventions used educational or reminding strategies, including one high quality RCT. Nine studies were of low/moderate quality. High quality RCTs using a theoretical framework for intervention selection are needed to identify strategies for improved adherence in these seniors.

Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework.

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Wilson, Caroline; Rooshenas, Leila; Paramasivan, Sangeetha; Elliott, Daisy; Jepson, Marcus; Strong, Sean; Birtle, Alison; Beard, David J; Halliday, Alison; Hamdy, Freddie C; Lewis, Rebecca; Metcalfe, Chris; Rogers, Chris A; Stein, Robert C; Blazeby, Jane M; Donovan, Jenny L

2018-01-19

Research has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexity of this pathway means that many patients do not have the opportunity to consider participation. This article presents the development of a simple framework to document, understand and improve the process of trial recruitment. Eight RCTs integrated a QuinteT Recruitment Intervention (QRI) into the main trial, feasibility or pilot study. Part of the QRI required mapping the patient recruitment pathway using trial-specific screening and recruitment logs. A content analysis compared the logs to identify aspects of the recruitment pathway and process that were useful in monitoring and improving recruitment. Findings were synthesised to develop an optimised simple framework that can be used in a wide range of RCTs. The eight trials recorded basic information about patients screened for trial participation and randomisation outcome. Three trials systematically recorded reasons why an individual was not enrolled in the trial, and further details why they were not eligible or approached, or declined randomisation. A framework to facilitate clearer recording of the recruitment process and reasons for non-participation was developed: SEAR - Screening, to identify potentially eligible trial participants; Eligibility, assessed against the trial protocol inclusion/exclusion criteria; Approach, the provision of oral and written information and invitation to participate in the trial, and Randomised or not, with the outcome of randomisation or treatment received. The SEAR framework encourages the collection of information to identify recruitment obstacles and facilitate improvements to the recruitment process. SEAR can be adapted to monitor recruitment to most RCTs, but is likely to add most value in trials where recruitment problems are anticipated or evident. Further work

[Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

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Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

2018-02-01

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials

Improving transparency and reproducibility through registration: The status of intervention trials published in clinical psychology journals.

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Cybulski, Lukasz; Mayo-Wilson, Evan; Grant, Sean

2016-09-01

Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Interventions for preventing unintended pregnancies among adolescents.

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Oringanje, Chioma; Meremikwu, Martin M; Eko, Hokehe; Esu, Ekpereonne; Meremikwu, Anne; Ehiri, John E

2016-02-03

Unintended pregnancy among adolescents represents an important public health challenge in high-income countries, as well as middle- and low-income countries. Numerous prevention strategies such as health education, skills-building and improving accessibility to contraceptives have been employed by countries across the world, in an effort to address this problem. However, there is uncertainty regarding the effects of these interventions, hence the need to review the evidence-base. To assess the effects of primary prevention interventions (school-based, community/home-based, clinic-based, and faith-based) on unintended pregnancies among adolescents. We searched all relevant studies regardless of language or publication status up to November 2015. We searched the Cochrane Fertility Regulation Group Specialised trial register, The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015 Issue 11), MEDLINE, EMBASE, LILACS, Social Science Citation Index and Science Citation Index, Dissertations Abstracts Online, The Gray Literature Network, HealthStar, PsycINFO, CINAHL and POPLINE and the reference lists of articles. We included both individual and cluster randomised controlled trials (RCTs) evaluating any interventions that aimed to increase knowledge and attitudes relating to risk of unintended pregnancies, promote delay in the initiation of sexual intercourse and encourage consistent use of birth control methods to reduce unintended pregnancies in adolescents aged 10 years to 19 years. Two authors independently assessed trial eligibility and risk of bias, and extracted data. Where appropriate, binary outcomes were pooled using a random-effects model with a 95% confidence interval (Cl). Where appropriate, we combined data in meta-analyses and assessed the quality of the evidence using the GRADE approach. We included 53 RCTs that enrolled 105,368 adolescents. Participants were ethnically diverse. Eighteen studies randomised individuals, 32

Broadening Participation in the Life Sciences with Social-Psychological Interventions

Science.gov (United States)

Tibbetts, Yoi; Harackiewicz, Judith M.; Priniski, Stacy J.; Canning, Elizabeth A.

2016-01-01

Randomized controlled trials (RCTs) have recently documented the positive effects of social-psychological interventions on the performance and retention of underrepresented students in the life sciences. We review two types of social-psychological interventions that address either students' well-being in college science courses or students'…

A Systematic Review of Psychosocial Interventions to Cancer Caregivers

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Fang Fu

2017-05-01

Full Text Available Objective: To systematically review the effect of psychosocial interventions on improving QoL, depression and anxiety of cancer caregivers.Methods: We conducted a systematic review of psychosocial interventions among adult cancer caregivers published from 2011 to 2016. PsycINFO, PubMed, Proquest, Cochrane Library, Embase, Applied Social Sciences Index and Abstracts (ASSIA, Cumulative Index to Nursing and Allied Health Literature, Social Sciences Citation Index (SSCI and EBSCO, China National Knowledge Infrastructure (CNKI and WANFANG were searched. Inclusion criteria were: randomized controlled trails (RCTs; psychosocial intervention to cancer caregivers; psychosocial health indicators including quality of life, depression or anxiety.Results: 21 studies out of 4,666 identified abstracts met inclusion criteria, including 19 RCTs. The intervention modes fell into the following nine categories: family connect intervention, self-determination theory-based intervention (SDT, cognitive behavioral therapy (CBT, emotion-focused therapy (EFT, comprehensive health enhancement support system (CHESS, FOCUS programme, existential behavioral therapy (EBT, telephone interpersonal counseling (TIP-C, problem-solving intervention (COPE.Conclusion: paired-intervention targeting self-care and interpersonal connections of caregivers and symptom management of patients is effective in improving quality of life and alleviating depression of cancer caregivers while music therapy is helpful for reducing anxiety of cancer caregivers.

Suicide intervention training evaluation: a preliminary report.

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Tierney, R J

1994-01-01

To date, very little work has been done on evaluating training in suicide intervention. This study developed and piloted a comprehensive method for evaluating suicide intervention training by applying three studies of immediate training effects on (a) suicide intervention abilities, (b) attitudes to suicide and suicide intervention, and (c) knowledge about suicide. The focus of the evaluation was a broadly used 2-day suicide intervention training program. Changes in suicide intervention abilities were measured by the Suicide Intervention Response Inventory (SIRI) and by performance in simulated suicide intervention situations, scored with the Suicide Intervention Protocol (SIP). Subjects consisted of 19 workshop participants in a pre-post condition and 17 participants in a post-test only condition. Results indicated significant increases in skills in suicide intervention situations. No significant effects were noted on the SIRI. Results from the attitudes and knowledge studies were very preliminary. They are reported here so that others may become aware of the methodology being used and the status of evaluation of the target program. Implications for further research are discussed.

No common denominator: a review of outcome measures in IVF RCTs.

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Wilkinson, Jack; Roberts, Stephen A; Showell, Marian; Brison, Daniel R; Vail, Andy

2016-12-01

Which outcome measures are reported in RCTs for IVF? Many combinations of numerator and denominator are in use, and are often employed in a manner that compromises the validity of the study. The choice of numerator and denominator governs the meaning, relevance and statistical integrity of a study's results. RCTs only provide reliable evidence when outcomes are assessed in the cohort of randomised participants, rather than in the subgroup of patients who completed treatment. Review of outcome measures reported in 142 IVF RCTs published in 2013 or 2014. Trials were identified by searching the Cochrane Gynaecology and Fertility Specialised Register. English-language publications of RCTs reporting clinical or preclinical outcomes in peer-reviewed journals in the period 1 January 2013 to 31 December 2014 were eligible. Reported numerators and denominators were extracted. Where they were reported, we checked to see if live birth rates were calculated correctly using the entire randomised cohort or a later denominator. Over 800 combinations of numerator and denominator were identified (613 in no more than one study). No single outcome measure appeared in the majority of trials. Only 22 (43%) studies reporting live birth presented a calculation including all randomised participants or only excluding protocol violators. A variety of definitions were used for key clinical numerators: for example, a consensus regarding what should constitute an ongoing pregnancy does not appear to exist at present. Several of the included articles may have been secondary publications. Our categorisation scheme was essentially arbitrary, so the frequencies we present should be interpreted with this in mind. The analysis of live birth denominators was post hoc. There is massive diversity in numerator and denominator selection in IVF trials due to its multistage nature, and this causes methodological frailty in the evidence base. The twin spectres of outcome reporting bias and analysis of non

A Systematic Review and Meta-Analysis Estimating the Expected Dropout Rates in Randomized Controlled Trials on Yoga Interventions.

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Cramer, Holger; Haller, Heidemarie; Dobos, Gustav; Lauche, Romy

2016-01-01

A reasonable estimation of expected dropout rates is vital for adequate sample size calculations in randomized controlled trials (RCTs). Underestimating expected dropouts rates increases the risk of false negative results while overestimating rates results in overly large sample sizes, raising both ethical and economic issues. To estimate expected dropout rates in RCTs on yoga interventions, MEDLINE/PubMed, Scopus, IndMED, and the Cochrane Library were searched through February 2014; a total of 168 RCTs were meta-analyzed. Overall dropout rate was 11.42% (95% confidence interval [CI] = 10.11%, 12.73%) in the yoga groups; rates were comparable in usual care and psychological control groups and were slightly higher in exercise control groups (rate = 14.53%; 95% CI = 11.56%, 17.50%; odds ratio = 0.82; 95% CI = 0.68, 0.98; p = 0.03). For RCTs with durations above 12 weeks, dropout rates in yoga groups increased to 15.23% (95% CI = 11.79%, 18.68%). The upper border of 95% CIs for dropout rates commonly was below 20% regardless of study origin, health condition, gender, age groups, and intervention characteristics; however, it exceeded 40% for studies on HIV patients or heterogeneous age groups. In conclusion, dropout rates can be expected to be less than 15 to 20% for most RCTs on yoga interventions. Yet dropout rates beyond 40% are possible depending on the participants' sociodemographic and health condition.

Effectiveness of holistic interventions for people with severe chronic obstructive pulmonary disease: systematic review of controlled clinical trials.

Directory of Open Access Journals (Sweden)

Ulugbek Nurmatov

Full Text Available Despite a well-recognised burden of disabling physical symptoms compounded by co-morbidities, psychological distress and social isolation, the needs of people with severe chronic obstructive pulmonary disease (COPD are typically poorly addressed.To assess the effectiveness of interventions designed to deliver holistic care for people with severe COPD.We searched 11 biomedical databases, three trial repositories (January 1990-March 2012; no language restrictions and contacted international experts to locate published, unpublished and in-progress randomised controlled trials (RCTs, quasi-RCTs and controlled clinical trials (CCTs that investigated holistic interventions to support patients with severe COPD in any healthcare context. The primary outcome was health-related quality of life (HRQoL. Quality assessment and data extraction followed Cochrane Collaboration methodology. We used a piloted data extraction sheet and undertook narrative synthesis.From 2,866 potentially relevant papers, we identified three trials: two RCTs (from United States and Australia, and one CCT (from Thailand: total 216 patients. Risk of bias was assessed as moderate in two studies and high in the third. All the interventions were led by nurses acting in a co-ordinating role (e.g. facilitating community support in Thailand, providing case-management in the USA, or co-ordinating inpatient care in Australia. HRQoL improved significantly in the Thai CCT compared to the (very limited usual care (p<0.001, in two sub-domains in the American trial, but showed no significant changes in the Australian trial. Exercise tolerance, dyspnoea, and satisfaction with care also improved in the Thai trial.Some 15 years after reports first highlighted the unmet needs of people with severe COPD, we have been unable to find robust trial evidence about interventions that can address those needs. There is an urgent need to develop and evaluate holistic care interventions designed improve HRQo

Born in Bradford’s Better Start: an experimental birth cohort study to evaluate the impact of early life interventions

Directory of Open Access Journals (Sweden)

Josie Dickerson

2016-08-01

Full Text Available Abstract Background Early interventions are recognised as key to improving life chances for children and reducing inequalities in health and well-being, however there is a paucity of high quality research into the effectiveness of interventions to address childhood health and development outcomes. Planning and implementing standalone RCTs for multiple, individual interventions would be slow, cumbersome and expensive. This paper describes the protocol for an innovative experimental birth cohort: Born in Bradford’s Better Start (BiBBS that will simultaneously evaluate the impact of multiple early life interventions using efficient study designs. Better Start Bradford (BSB has been allocated £49 million from the Big Lottery Fund to implement 22 interventions to improve outcomes for children aged 0–3 in three key areas: social and emotional development; communication and language development; and nutrition and obesity. The interventions will be implemented in three deprived and ethnically diverse inner city areas of Bradford. Method The BiBBS study aims to recruit 5000 babies, their mothers and their mothers’ partners over 5 years from January 2016-December 2020. Demographic and socioeconomic information, physical and mental health, lifestyle factors and biological samples will be collected during pregnancy. Parents and children will be linked to their routine health and local authority (including education data throughout the children’s lives. Their participation in BSB interventions will also be tracked. BiBBS will test interventions using the Trials within Cohorts (TwiCs approach and other quasi-experimental designs where TwiCs are neither feasible nor ethical, to evaluate these early life interventions. The effects of single interventions, and the cumulative effects of stacked (multiple interventions on health and social outcomes during the critical early years will be measured. Discussion The focus of the BiBBS cohort is on

The research gap in chronic paediatric pain: A systematic review of randomised controlled trials.

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Boulkedid, R; Abdou, A Y; Desselas, E; Monégat, M; de Leeuw, T G; Avez-Couturier, J; Dugue, S; Mareau, C; Charron, B; Alberti, C; Kaguelidou, F

2018-02-01

Chronic pain is associated with significant functional and social impairment. The objective of this review was to assess the characteristics and quality of randomized controlled trials (RCTs) evaluating pain management interventions in children and adolescents with chronic pain. We performed a systematic search of PubMed, Embase and the Cochrane Library up to July 2017. We included RCTs that involved children and adolescents (3 months-18 years) and evaluated the use of pharmacological or non-pharmacological intervention(s) in the context of pain persisting or re-occurring for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias (ROB) Tool. A total of 58 RCTs were identified and numbers steadily increased over time. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 47.5 participants (Q1,Q3: 32, 70). Forty-five percent of RCTs included both adults and children and the median of the mean ages at inclusion was 12.9 years (Q1,Q3: 11, 15). Testing of non-pharmacological interventions was predominant and only 5 RCTs evaluated analgesics or co-analgesics. Abdominal pain, headache/migraine and musculoskeletal pain were the most common types of chronic pain among participants. Methodological quality was poor with 90% of RCTs presenting a high or unclear ROB. Evaluation of analgesics targeting chronic pain relief in children and adolescents through RCTs is marginal. Infants and children with long-lasting painful conditions are insufficiently represented in RCTs. We discuss possible research constraints and challenges as well as methodologies to circumvent them. There is a substantial research gap regarding analgesic interventions for children and adolescents with chronic pain. Most clinical trials in the field focus on the evaluation of non-pharmacological interventions and are of low methodological quality. There is also a specific lack of trials involving infants

Fundamental movement skill interventions in youth: a systematic review and meta-analysis.

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Morgan, Philip J; Barnett, Lisa M; Cliff, Dylan P; Okely, Anthony D; Scott, Hayley A; Cohen, Kristen E; Lubans, David R

2013-11-01

Fundamental movement skill (FMS) proficiency is positively associated with physical activity and fitness levels. The objective of this study was to systematically review evidence for the benefits of FMS interventions targeting youth. A search with no date restrictions was conducted across 7 databases. Studies included any school-, home-, or community-based intervention for typically developing youth with clear intent to improve FMS proficiency and that reported statistical analysis of FMS competence at both preintervention and at least 1 other postintervention time point. Study designs included randomized controlled trials (RCTs) using experimental and quasi-experimental designs and single group pre-post trials. Risk of bias was independently assessed by 2 reviewers. Twenty-two articles (6 RCTs, 13 quasi-experimental trials, 3 pre-post trials) describing 19 interventions were included. All but 1 intervention were evaluated in primary/elementary schools. All studies reported significant intervention effects for ≥ 1 FMS. Meta-analyses revealed large effect sizes for overall gross motor proficiency (standardized mean difference [SMD] = 1.42, 95% confidence interval [CI] 0.68-2.16, Z = 3.77, P skill competency (SMD = 1.42, 95% CI 0.56-2.27, Z = 3.25, P = .001). A medium effect size for object control skill competency was observed (SMD = 0.63, 95% CI 0.28-0.98, Z = 3.53, P = .0004). Many studies scored poorly for risk of bias items. School- and community-based programs that include developmentally appropriate FMS learning experiences delivered by physical education specialists or highly trained classroom teachers significantly improve FMS proficiency in youth.

Do problem-solving interventions improve psychosocial outcomes in vision impaired adults: a systematic review and meta-analysis.

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Holloway, Edith E; Xie, Jing; Sturrock, Bonnie A; Lamoureux, Ecosse L; Rees, Gwyneth

2015-05-01

To evaluate the effectiveness of problem-solving interventions on psychosocial outcomes in vision impaired adults. A systematic search of randomised controlled trials (RCTs), published between 1990 and 2013, that investigated the impact of problem-solving interventions on depressive symptoms, emotional distress, quality of life (QoL) and functioning was conducted. Two reviewers independently selected and appraised study quality. Data permitting, intervention effects were statistically pooled and meta-analyses were performed, otherwise summarised descriptively. Eleven studies (reporting on eight trials) met inclusion criteria. Pooled analysis showed problem-solving interventions improved vision-related functioning (standardised mean change [SMC]: 0.15; 95% CI: 0.04-0.27) and emotional distress (SMC: -0.36; 95% CI: -0.54 to -0.19). There was no evidence to support improvements in depressive symptoms (SMC: -0.27, 95% CI: -0.66 to 0.12) and insufficient evidence to determine the effectiveness of problem-solving interventions on QoL. The small number of well-designed studies and narrow inclusion criteria limit the conclusions drawn from this review. However, problem-solving skills may be important for nurturing daily functioning and reducing emotional distress for adults with vision impairment. Given the empirical support for the importance of effective problem-solving skills in managing chronic illness, more well-designed RCTs are needed with diverse vision impaired samples. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Impact of rehabilitation on self-concept following traumatic brain injury: An exploratory systematic review of intervention methodology and efficacy.

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Ownsworth, Tamara; Haslam, Catherine

2016-01-01

To date, reviews of rehabilitation efficacy after traumatic brain injury (TBI) have overlooked the impact on sense of self, focusing instead on functional impairment and psychological distress. The present review sought to address this gap by critically appraising the methodology and efficacy of intervention studies that assess changes in self-concept. A systematic search of PsycINFO, Medline, CINAHL and PubMed was conducted from inception to September 2013 to identify studies reporting pre- and post-intervention changes on validated measures of self-esteem or self-concept in adults with TBI. Methodological quality of randomised controlled trials (RCTs) was examined using the Physiotherapy Evidence Database (PEDro) scale. A total of 17 studies (10 RCTs, 4 non-RCT group studies, 3 case studies) was identified, which examined the impact of psychotherapy, family-based support, cognitive rehabilitation or activity-based interventions on self-concept. The findings on the efficacy of these interventions were mixed, with only 10 studies showing some evidence of improvement in self-concept based on within-group or pre-post comparisons. Such findings highlight the need for greater focus on the impact of rehabilitation on self-understanding with improved assessment and intervention methodology. We draw upon theories of identity reconstruction and highlight implications for the design and evaluation of identity-oriented interventions that can supplement existing rehabilitation programmes for people with TBI.

Interventions for the treatment of Frey's syndrome.

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Li, Chunjie; Wu, Fanglong; Zhang, Qi; Gao, Qinghong; Shi, Zongdao; Li, Longjiang

2015-03-17

Frey's syndrome is a rare disorder, the symptoms of which include sweating, flushing and warming over the preauricular and temporal areas following a gustatory stimulus. It often occurs in patients who have undergone parotidectomy, submandibular gland surgery, radical neck dissection, infection and traumatic injury in the parotid region, and is caused by the aberrant regrowth of facial autonomic nerve fibres. Currently there are several options used to treat patients with Frey's syndrome; for example, the topical application of anticholinergics and antiperspirants, and the intradermal injection of botulinum toxin. It is uncertain which treatment is most effective and safe. To assess the efficacy and safety of different interventions for the treatment of Frey's syndrome. We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; ICTRP and additional sources for published and unpublished trials. The date of the search was 28 April 2014. We included randomised or quasi-randomised controlled trials (RCTs) in participants diagnosed with Frey's syndrome using a clinical standard such as Minor's starch-iodine test. We planned to include trials in which participants received any intervention versus no treatment (observation) or an alternative intervention, with or without a second active treatment. Our primary outcome measures were success rate (as assessed clinically by Minor's starch-iodine test, the iodine-sublimated paper histogram method, blotting paper technique or another method) and adverse events. Our secondary outcome measure was success rate as assessed by patients (disappearance or improvement of symptoms). We used the standard methodological procedures expected by The Cochrane Collaboration. We identified no RCTs or quasi-RCTs that fulfilled the inclusion criteria. Our searches retrieved eight potentially relevant studies, but after

Cognitive motor intervention for gait and balance in Parkinson's disease: systematic review and meta-analysis.

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Wang, Xue-Qiang; Pi, Yan-Ling; Chen, Bing-Lin; Wang, Ru; Li, Xin; Chen, Pei-Jie

2016-02-01

We performed a systematic review and meta-analysis to assess the effect of cognitive motor intervention (CMI) on gait and balance in Parkinson's disease. PubMed, Embase, Cochrane Library, CINAHL, Web of Science, PEDro, and China Biology Medicine disc. We included randomized controlled trials (RCTs) and non RCTs. Two reviewers independently evaluated articles for eligibility and quality and serially abstracted data. A standardized mean difference ± standard error and 95% confidence interval (CI) was calculated for each study using Hedge's g to quantify the treatment effect. Nine trials with 181 subjects, four randomized controlled trials, and five single group intervention studies were included. The pooling revealed that cognitive motor intervention can improve gait speed (Hedge's g = 0.643 ± 0.191; 95% CI: 0.269 to 1.017, P = 0.001), stride time (Hedge's g = -0.536 ± 0.167; 95% CI: -0.862 to -0.209, P = 0.001), Berg Balance Scale (Hedge's g = 0.783 ± 0.289; 95% CI: 0.218 to 1.349, P = 0.007), Unipedal Stance Test (Hedge's g = 0.440 ± 0.189; 95% CI: 0.07 to 0.81, P =0.02). The systematic review demonstrates that cognitive motor intervention is effective for gait and balance in Parkinson's disease. However, the paper is limited by the quality of the included trials. © The Author(s) 2015.

Effects of Nurse-Led Telephone-Based Supportive Interventions for Patients With Cancer: A Meta-Analysis.

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Suh, Soon-Rim; Lee, Myung Kyung

2017-07-01

To evaluate the effects of nurse-led telephone-based supportive interventions (NTSIs) for patients with cancer.
. Electronic databases, including EMBASE®, MEDLINE, Google Scholar, 
Cochrane Library CENTRAL, ProQuest Medical Library, and CINAHL®, were searched through February 2016.
. 239 studies were identified; 16 were suitable for meta-analysis. Cochrane's risk of bias tool and the Comprehensive Meta-Analysis software were used.
. The authors performed a meta-analysis of 16 trials that met eligibility criteria. Thirteen randomized, controlled trials (RCTs) and three non-RCTs examined a total of 2,912 patients with cancer. Patients who received NTSIs were compared with those who received attentional control or usual care (no intervention).
. Telephone interventions delivered by a nurse in an oncology care setting reduced cancer symptoms with a moderate effect size (ES) (-0.33) and emotional distress with a small ES (-0.12), and improved self-care with a large ES (0.64) and health-related quality of life (HRQOL) with a small ES (0.3). Subgroup analyses indicated that the significant effects of NTSIs on cancer symptoms, emotional distress, and HRQOL were larger for studies that combined an application of a theoretical framework, had a control group given usual care, and used an RTC design.
. The findings suggest that an additional tiered evaluation that has a theoretical underpinning and high-quality methodology is required to confirm the efficacy of NTSI for adoption of specific care models.

Specialty substance use disorder services following brief alcohol intervention: a meta-analysis of randomized controlled trials.

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Glass, Joseph E; Hamilton, Ashley M; Powell, Byron J; Perron, Brian E; Brown, Randall T; Ilgen, Mark A

2015-09-01

Brief alcohol interventions in medical settings are efficacious in improving self-reported alcohol consumption among those with low-severity alcohol problems. Screening, Brief Intervention and Referral to Treatment initiatives presume that brief interventions are efficacious in linking patients to higher levels of care, but pertinent evidence has not been evaluated. We estimated main and subgroup effects of brief alcohol interventions, regardless of their inclusion of a referral-specific component, in increasing the utilization of alcohol-related care. A systematic review of English language papers published in electronic databases to 2013. We included randomized controlled trials (RCTs) of brief alcohol interventions in general health-care settings with adult and adolescent samples. We excluded studies that lacked alcohol services utilization data. Extractions of study characteristics and outcomes were standardized and conducted independently. The primary outcome was post-treatment alcohol services utilization assessed by self-report or administrative data, which we compared across intervention and control groups. Thirteen RCTs met inclusion criteria and nine were meta-analyzed (n = 993 and n = 937 intervention and control group participants, respectively). In our main analyses the pooled risk ratio (RR) was = 1.08, 95% confidence interval (CI) = 0.92-1.28. Five studies compared referral-specific interventions with a control condition without such interventions (pooled RR = 1.08, 95% CI = 0.81-1.43). Other subgroup analyses of studies with common characteristics (e.g. age, setting, severity, risk of bias) yielded non-statistically significant results. There is a lack of evidence that brief alcohol interventions have any efficacy for increasing the receipt of alcohol-related services. © 2015 Society for the Study of Addiction.

Interventions for weight reduction in obesity to improve survival in women with endometrial cancer.

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Kitson, Sarah; Ryan, Neil; MacKintosh, Michelle L; Edmondson, Richard; Duffy, James Mn; Crosbie, Emma J

2018-02-01

Diagnoses of endometrial cancer are increasing secondary to the rising prevalence of obesity. Obesity plays an important role in promoting the development of endometrial cancer, by inducing a state of unopposed oestrogen excess, insulin resistance and inflammation. It also affects treatment, increasing the risk of surgical complications and the complexity of radiotherapy planning, and may additionally impact on subsequent survival. Weight-loss interventions have been associated with improvements in breast and colorectal cancer-specific survival as well as a reduction in the risk of cardiovascular disease, a frequent cause of death in endometrial cancer survivors. To determine the impact of weight-loss interventions, in addition to standard management of endometrial cancer, on overall survival and the frequency of adverse events.Secondary objectives include an assessment of weight-loss interventions on endometrial cancer-specific survival, weight loss achieved, cardiovascular event frequency and quality of life both overall and stratified according to patient body mass index (BMI), where possible. This review searched Cochrane Central Register of Controlled Trials, MEDLINE, Embase and reference lists of articles, trial registries, and international gynaecological oncology conference abstracts from inception to January 2018. Randomised controlled trials (RCTs) of interventions to facilitate weight loss in overweight or obese women undergoing treatment for, or previously treated for, endometrial cancer were selected. Two review authors independently selected studies, assessed trial quality, and extracted data with disagreements resolved by a third review author. Study authors were contacted to obtain missing data, including details of any adverse events. We included three RCTs in the review, randomising a total of 161 overweight and obese women with endometrial cancer. All studies compared combined behavioural and lifestyle interventions to facilitate weight loss

A Systematic Review and Meta-Analysis Estimating the Expected Dropout Rates in Randomized Controlled Trials on Yoga Interventions

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Holger Cramer

2016-01-01

Full Text Available A reasonable estimation of expected dropout rates is vital for adequate sample size calculations in randomized controlled trials (RCTs. Underestimating expected dropouts rates increases the risk of false negative results while overestimating rates results in overly large sample sizes, raising both ethical and economic issues. To estimate expected dropout rates in RCTs on yoga interventions, MEDLINE/PubMed, Scopus, IndMED, and the Cochrane Library were searched through February 2014; a total of 168 RCTs were meta-analyzed. Overall dropout rate was 11.42% (95% confidence interval [CI] = 10.11%, 12.73% in the yoga groups; rates were comparable in usual care and psychological control groups and were slightly higher in exercise control groups (rate = 14.53%; 95% CI = 11.56%, 17.50%; odds ratio = 0.82; 95% CI = 0.68, 0.98; p=0.03. For RCTs with durations above 12 weeks, dropout rates in yoga groups increased to 15.23% (95% CI = 11.79%, 18.68%. The upper border of 95% CIs for dropout rates commonly was below 20% regardless of study origin, health condition, gender, age groups, and intervention characteristics; however, it exceeded 40% for studies on HIV patients or heterogeneous age groups. In conclusion, dropout rates can be expected to be less than 15 to 20% for most RCTs on yoga interventions. Yet dropout rates beyond 40% are possible depending on the participants’ sociodemographic and health condition.

Effective behavioral intervention strategies using mobile health applications for chronic disease management: a systematic review.

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Lee, Jung-Ah; Choi, Mona; Lee, Sang A; Jiang, Natalie

2018-02-20

Mobile health (mHealth) has continuously been used as a method in behavioral research to improve self-management in patients with chronic diseases. However, the evidence of its effectiveness in chronic disease management in the adult population is still lacking. We conducted a systematic review to examine the effectiveness of mHealth interventions on process measures as well as health outcomes in randomized controlled trials (RCTs) to improve chronic disease management. Relevant randomized controlled studies that were published between January 2005 and March 2016 were searched in six databases: PubMed, CINAHL, EMBASE, the Cochrane Library, PsycINFO, and Web of Science. The inclusion criteria were RCTs that conducted an intervention using mobile devices such as smartphones or tablets for adult patients with chronic diseases to examine disease management or health promotion. Of the 12 RCTs reviewed, 10 of the mHealth interventions demonstrated statistically significant improvement in some health outcomes. The most common features of mHealth systems used in the reviewed RCTs were real-time or regular basis symptom assessments, pre-programed reminders, or feedbacks tailored specifically to the data provided by participants via mHealth devices. Most studies developed their own mHealth systems including mobile apps. Training of mHealth systems was provided to participants in person or through paper-based instructions. None of the studies reported the relationship between health outcomes and patient engagement levels on the mHealth system. Findings from mHealth intervention studies for chronic disease management have shown promising aspects, particularly in improving self-management and some health outcomes.

Internet-based interventions for smoking cessation.

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Taylor, Gemma M J; Dalili, Michael N; Semwal, Monika; Civljak, Marta; Sheikh, Aziz; Car, Josip

2017-09-04

Tobacco use is estimated to kill 7 million people a year. Nicotine is highly addictive, but surveys indicate that almost 70% of US and UK smokers would like to stop smoking. Although many smokers attempt to give up on their own, advice from a health professional increases the chances of quitting. As of 2016 there were 3.5 billion Internet users worldwide, making the Internet a potential platform to help people quit smoking. To determine the effectiveness of Internet-based interventions for smoking cessation, whether intervention effectiveness is altered by tailoring or interactive features, and if there is a difference in effectiveness between adolescents, young adults, and adults. We searched the Cochrane Tobacco Addiction Group Specialised Register, which included searches of MEDLINE, Embase and PsycINFO (through OVID). There were no restrictions placed on language, publication status or publication date. The most recent search was conducted in August 2016. We included randomised controlled trials (RCTs). Participants were people who smoked, with no exclusions based on age, gender, ethnicity, language or health status. Any type of Internet intervention was eligible. The comparison condition could be a no-intervention control, a different Internet intervention, or a non-Internet intervention. To be included, studies must have measured smoking cessation at four weeks or longer. Two review authors independently assessed and extracted data. We extracted and, where appropriate, pooled smoking cessation outcomes of six-month follow-up or more, reporting short-term outcomes narratively where longer-term outcomes were not available. We reported study effects as a risk ratio (RR) with a 95% confidence interval (CI).We grouped studies according to whether they (1) compared an Internet intervention with a non-active control arm (e.g. printed self-help guides), (2) compared an Internet intervention with an active control arm (e.g. face-to-face counselling), (3) evaluated the

Public health interventions: evaluating the economic evaluations

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Martin Forster

2013-10-01

Full Text Available Recent years have witnessed much progress in the incorporation of economic considerations into the evaluation of public health interventions. In England, the Centre for Public Health Excellence within the National Institute for Health and Care Excellence works to develop guidance for preventing illness and assessing which public health interventions are most effective and provide best value for money...

Systematic review of effect of community-level interventions to reduce maternal mortality

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Deeks Jonathan J

2009-01-01

Full Text Available Abstract Background The objective was to provide a systematic review of the effectiveness of community-level interventions to reduce maternal mortality. Methods We searched published papers using Medline, Embase, Cochrane library, CINAHL, BNI, CAB ABSTRACTS, IBSS, Web of Science, LILACS and African Index Medicus from inception or at least 1982 to June 2006; searched unpublished works using National Research Register website, metaRegister and the WHO International Trial Registry portal. We hand searched major references. Selection criteria were maternity or childbearing age women, comparative study designs with concurrent controls, community-level interventions and maternal death as an outcome. We carried out study selection, data abstraction and quality assessment independently in duplicate. Results We found five cluster randomised controlled trials (RCT and eight cohort studies of community-level interventions. We summarised results as odds ratios (OR and confidence intervals (CI, combined using the Peto method for meta-analysis. Two high quality cluster RCTs, aimed at improving perinatal care practices, showed a reduction in maternal mortality reaching statistical significance (OR 0.62, 95% CI 0.39 to 0.98. Three equivalence RCTs of minimal goal-oriented versus usual antenatal care showed no difference in maternal mortality (1.09, 95% CI 0.53 to 2.25. The cohort studies were of low quality and did not contribute further evidence. Conclusion Community-level interventions of improved perinatal care practices can bring about a reduction in maternal mortality. This challenges the view that investment in such interventions is not worthwhile. Programmes to improve maternal mortality should be evaluated using randomised controlled techniques to generate further evidence.

Interventions to support people with dementia and their caregivers during the transition from home care to nursing home care: A systematic review.

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Müller, Christian; Lautenschläger, Sindy; Meyer, Gabriele; Stephan, Astrid

2017-06-01

During the transition of people with dementia from home to nursing home family caregivers often feel burdened. We aimed to 1) identify interventions which support people with dementia and their caregivers in the transition from home care to nursing home care, 2) synthesize the evidence for efficacy of these interventions, and 3) examine whether the identified interventions have been systematically developed, evaluated and implemented according to the Medical Research Council guidance on complex interventions. A systematic review of randomised controlled trials was conducted according to the recommendations specified in the Cochrane Handbook for Intervention Reviews. The review protocol was registered in PROSPERO (2015: CRD42015019839). Reporting follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement. MEDLINE, CENTRAL, PsycINFO, CINAHL, OTseeker, and PEDro, were searched. Other sources included Google Scholar, and ALOIS. Two reviewers independently assessed the eligibility of the articles. Data extraction was performed by one reviewer and verified independently by another. The Cochrane Risk of Bias tool was used for critical appraisal. Development and evaluation of the identified interventions were assessed, taking the Medical Research Council guidance into account. Review findings were synthesized narratively. The search yielded 1278 records. Five studies were included, all conducted in the United States (4 RCTs and 1 cRCT with a total of 695 participants). The psychosocial interventions were individual and family counseling via telephone or ad hoc all of which addressed only informal caregivers. The intervention components, content and mode of delivery differed widely with inconsistent results. Significant intervention effects were found for the reduction of caregivers' depressive symptoms, burden, feeling of guilt, emotional distress, overload, and interactions with staff. Other outcomes, i.e. stress, placement

A systematic review and meta-analysis of the effectiveness of food safety education interventions for consumers in developed countries.

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Young, Ian; Waddell, Lisa; Harding, Shannon; Greig, Judy; Mascarenhas, Mariola; Sivaramalingam, Bhairavi; Pham, Mai T; Papadopoulos, Andrew

2015-08-26

Foodborne illness has a large public health and economic burden worldwide, and many cases are associated with food handled and prepared at home. Educational interventions are necessary to improve consumer food safety practices and reduce the associated burden of foodborne illness. We conducted a systematic review and targeted meta-analyses to investigate the effectiveness of food safety education interventions for consumers. Relevant articles were identified through a preliminary scoping review that included: a comprehensive search in 10 bibliographic databases with verification; relevance screening of abstracts; and extraction of article characteristics. Experimental studies conducted in developed countries were prioritized for risk-of-bias assessment and data extraction. Meta-analysis was conducted on data subgroups stratified by key study design-intervention-population-outcome categories and subgroups were assessed for their quality of evidence. Meta-regression was conducted where appropriate to identify possible sources of between-trial heterogeneity. We identified 79 relevant studies: 17 randomized controlled trials (RCTs); 12 non-randomized controlled trials (NRTs); and 50 uncontrolled before-and-after studies. Several studies did not provide sufficient details on key design features (e.g. blinding), with some high risk-of-bias ratings due to incomplete outcome data and selective reporting. We identified a moderate to high confidence in results from two large RCTs investigating community- and school-based educational training interventions on behaviour outcomes in children and youth (median standardized mean difference [SMD] = 0.20, range: 0.05, 0.35); in two small RCTs evaluating video and written instructional messaging on behavioural intentions in adults (SMD = 0.36, 95% confidence interval [CI]: 0.02, 0.69); and in two NRT studies for university-based education on attitudes of students and staff (SMD = 0.26, 95% CI: 0.10, 0.43). Uncontrolled before

The impact of interventions to improve the quality of prescribing and use of antibiotics in primary care patients with respiratory tract infections: a systematic review protocol.

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Martínez-González, Nahara Anani; Coenen, Samuel; Plate, Andreas; Colliers, Annelies; Rosemann, Thomas; Senn, Oliver; Neuner-Jehle, Stefan

2017-06-13

Respiratory tract infections (RTIs) are the most common reason for primary care (PC) consultations and for antibiotic prescribing and use. The majority of RTIs have a viral aetiology however, and antibiotic consumption is ineffective and unnecessary. Inappropriate antibiotic use contributes greatly to antibiotic resistance (ABR) leading to complications, increased adverse events, reconsultations and costs. Improving antibiotic consumption is thus crucial to containing ABR, which has become an urgent priority worldwide. We will systematically review the evidence about interventions aimed at improving the quality of antibiotic prescribing and use for acute RTI. We will include primary peer-reviewed and grey literature of studies conducted on in-hours and out-of-hours PC patients (adults and children): (1) randomised controlled trials (RCTs), quasi-RCTs and/or cluster-RCTs evaluating the effectiveness, feasibility and acceptability of patient-targeted and clinician-targeted interventions and (2) RCTs and other study designs evaluating the effectiveness of public campaigns and regulatory interventions. We will search MEDLINE (EBSCOHost), EMBASE (Elsevier), the Cochrane Library (Wiley), CINHAL (EBSCOHost), PsychINFO (EBSCOHost), Web of Science, LILACS (Latin American and Caribbean Literature on Health Sciences), TRIP (Turning Research Into Practice) and opensgrey.eu without language restriction. We will also search the reference lists of included studies and relevant reviews. Primary outcomes include the rates of (guideline-recommended) antibiotics prescribed and/or used. Secondary outcomes include immediate or delayed use of antibiotics, and feasibility and acceptability outcomes. We will assess study eligibility and risk of bias, and will extract data. Data permitting, we will perform meta-analyses. This is a systematic review protocol and so formal ethical approval is not required. We will not collect confidential, personal or primary data. The findings of this

Online alcohol interventions: a systematic review.

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White, Angela; Kavanagh, David; Stallman, Helen; Klein, Britt; Kay-Lambkin, Frances; Proudfoot, Judy; Drennan, Judy; Connor, Jason; Baker, Amanda; Hines, Emily; Young, Ross

2010-12-19

There has been a significant increase in the availability of online programs for alcohol problems. A systematic review of the research evidence underpinning these programs is timely. Our objective was to review the efficacy of online interventions for alcohol misuse. Systematic searches of Medline, PsycINFO, Web of Science, and Scopus were conducted for English abstracts (excluding dissertations) published from 1998 onward. Search terms were: (1) Internet, Web*; (2) online, computer*; (3) alcohol*; and (4) E\\effect*, trial*, random* (where * denotes a wildcard). Forward and backward searches from identified papers were also conducted. Articles were included if (1) the primary intervention was delivered and accessed via the Internet, (2) the intervention focused on moderating or stopping alcohol consumption, and (3) the study was a randomized controlled trial of an alcohol-related screen, assessment, or intervention. The literature search initially yielded 31 randomized controlled trials (RCTs), 17 of which met inclusion criteria. Of these 17 studies, 12 (70.6%) were conducted with university students, and 11 (64.7%) specifically focused on at-risk, heavy, or binge drinkers. Sample sizes ranged from 40 to 3216 (median 261), with 12 (70.6%) studies predominantly involving brief personalized feedback interventions. Using published data, effect sizes could be extracted from 8 of the 17 studies. In relation to alcohol units per week or month and based on 5 RCTs where a measure of alcohol units per week or month could be extracted, differential effect sizes to posttreatment ranged from 0.02 to 0.81 (mean 0.42, median 0.54). Pre-post effect sizes for brief personalized feedback interventions ranged from 0.02 to 0.81, and in 2 multi-session modularized interventions, a pre-post effect size of 0.56 was obtained in both. Pre-post differential effect sizes for peak blood alcohol concentrations (BAC) ranged from 0.22 to 0.88, with a mean effect size of 0.66. The available

Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery

Science.gov (United States)

Van Lieshout, Ryan J.; Schmidt, Louis A.; Dobson, Kathleen G.; Buckley, Norman

2016-01-01

Objective To examine the effectiveness of Audiovisual (AV) interventions at reducing preoperative anxiety and its associated outcomes in children undergoing elective surgery. Methods A systematic review of randomized controlled trials (RCTs) and nonrandomized studies where the primary outcome was children’s preoperative anxiety was conducted. Secondary outcomes included postoperative pain, behavioral changes, recovery, induction compliance, satisfaction, and cost-effectiveness. The risk of bias of each study was assessed. Results In all, 18 studies were identified. A meta-analytic approach and narrative synthesis of findings were used to summarize the results of the studies. Conclusions This systematic review suggests that AV interventions can be effective in reducing children’s preoperative anxiety. Videos, multi-faceted programs, and interactive games appear to be most effective, whereas music therapy and Internet programs are less effective. While AV interventions appear potentially useful, adequately powered RCTs are required to conclusively pinpoint the components and mechanisms of the most effective AV interventions and guide practice. PMID:26476281

Oral health educational interventions for nursing home staff and residents.

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Albrecht, Martina; Kupfer, Ramona; Reissmann, Daniel R; Mühlhauser, Ingrid; Köpke, Sascha

2016-09-30

Associations between nursing home residents' oral health status and quality of life, respiratory tract infections, and nutritional status have been reported. Educational interventions for nurses or residents, or both, focusing on knowledge and skills related to oral health management may have the potential to improve residents' oral health. To assess the effects of oral health educational interventions for nursing home staff or residents, or both, to maintain or improve the oral health of nursing home residents. We searched the Cochrane Oral Health Trials Register (to 18 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2015, Issue 12), MEDLINE Ovid (1946 to 18 January 2016), Embase Ovid (1980 to 18 January 2016), CINAHL EBSCO (1937 to 18 January 2016), and Web of Science Conference Proceedings (1990 to 18 January 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials to 18 January 2016. In addition, we searched reference lists of identified articles and contacted experts in the field. We placed no restrictions on language or date of publication when searching the electronic databases. Randomised controlled trials (RCTs) and cluster-RCTs comparing oral health educational programmes for nursing staff or residents, or both with usual care or any other oral healthcare intervention. Two review authors independently screened articles retrieved from the searches for relevance, extracted data from included studies, assessed risk of bias for each included study, and evaluated the overall quality of the evidence. We retrieved data about the development and evaluation processes of complex interventions on the basis of the Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2). We contacted authors of relevant studies for additional information. We included nine RCTs involving

Interventions to treat premature ejaculation: a systematic review short report.

Science.gov (United States)

Cooper, Katy; Martyn-St James, Marrissa; Kaltenthaler, Eva; Dickinson, Kath; Cantrell, Anna

2015-03-01

Premature ejaculation (PE) is commonly defined as ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the person wishes it. PE can be either lifelong and present since first sexual experiences (primary), or acquired (secondary), beginning later (Godpodinoff ML. Premature ejaculation: clinical subgroups and etiology. J Sex Marital Ther 1989;15:130-4). Treatments include behavioural and pharmacological interventions. To systematically review evidence for clinical effectiveness of behavioural, topical and systemic treatments for PE. The following databases were searched from inception to 6 August 2013 for published and unpublished research evidence: MEDLINE; EMBASE; Cumulative Index to Nursing and Allied Health Literature; The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects and the Health Technology Assessment database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science. The US Food and Drug Administration website and the European Medicines Agency (EMA) website were also searched. Randomised controlled trials (RCTs) in adult men with PE were eligible (or non-RCTs in the absence of RCTs). RCT data were extrapolated from review articles when available. The primary outcome was intravaginal ejaculatory latency time (IELT). Data were meta-analysed when possible. Other outcomes included sexual satisfaction, control over ejaculation, relationship satisfaction, self-esteem, quality of life, treatment acceptability and adverse events (AEs). A total of 103 studies (102 RCTs, 65 from reviews) were included. RCTs were available for all interventions except yoga. The following interventions demonstrated significant improvements (p < 0.05) in arithmetic mean difference in IELT compared with placebo: topical anaesthetics - eutectic mixture of local anaesthetics (EMLA(®), Astra

Change in interpersonal functioning during psychological interventions for borderline personality disorder—a systematic review of measures and efficacy.

Science.gov (United States)

Sinnaeve, Roland; van den Bosch, Louisa M C; van Steenbergen-Weijenburg, Kirsten M

2015-08-01

To provide a systematic review of measures of interpersonal functioning used in treatments for people diagnosed with borderline personality disorder (BPD) and to report the effectiveness of treatments on these measures of interpersonal functioning. Literature was reviewed using the online databases and reference lists of previous systematic reviews. Selected studies were randomized controlled trials (RCTs) that examined psychotherapeutic interventions for people with BPD and contained quantitative outcomes on various aspects of interpersonal functioning and reported their results in peer-reviewed journals. Reliability and validity of the results were evaluated. Nineteen RCTs met our inclusion criteria. We found 16 different (sub)scales that measured some aspect of interpersonal functioning. Only four instruments were used by more than one research team. There is some evidence that psychotherapeutic interventions have beneficial effects on some aspects of interpersonal functioning in people diagnosed with BPD, both after individual and group therapy. Generalizability of these findings is limited. There is preliminary evidence that psychotherapeutic interventions have beneficial effects on various aspects of interpersonal reactivity that characterize people diagnosed with BPD. However, none of these effects have a robust evidence base. There are serious concerns about the lack of agreed-upon concepts and instruments. Copyright © 2015 John Wiley & Sons, Ltd.

Clinical evaluation of marketed orthodontic products: are researchers behind the times? A meta-epidemiological study

Directory of Open Access Journals (Sweden)

Jadbinder Seehra

2017-05-01

Full Text Available Abstract Background The role of marketing and industry in the treatment decisions of orthodontists has received increasing attention in recent years with clinical research typically undertaken subsequent to established use of these devices and often failing to confirm the promise of manufacturers’ claims. This meta-epidemiological study was undertaken to assess the proportion of clinical trials in orthodontics evaluating commercially marketed products and to evaluate the direction of the results of these studies. Methods Electronic searching was undertaken to identify randomized controlled trials (RCTs published over a 5-year period (1 January 2012 to 31 December 2016. Data obtained included the type of marketed intervention, direction of effect and declaration of both industry sponsorship and conflict of interest. Results Eighty-four RCTs published in 23 scientific journals were included with the highest percentage in the American Journal of Dentofacial Orthopedics (AJO-DO (23.8%, followed by the European Journal of Orthodontics (EJO (14.3%, Journal of Orthodontics (JO (10.7% and Angle Orthodontist (AO (10.7%. Overall, 45% (38/84 of clinical trials assessed involved analysis of marketed products after their introduction. Interventions to improve oral health or circumvent the risk of iatrogenic damage, such as white spot lesions, were most commonly assessed (15.8%, with the relative merits of non-surgical adjuncts (14.1% and other orthodontic auxiliaries (13.1% also frequently evaluated. In 44% of RCTs, a positive effect of the marketed intervention was not reported. Industry sponsorship of the research was declared in 9.5% RCTs. No significant associations between the direction of the effect and both declaration of industry sponsorship (p = 0.56 and conflict of interest (p = 0.96 were detected. Moreover, for marketed and non-marketed products, no significant associations for both declaration of industry sponsorship (p = 0.44 and

Enhancing reporting of behavior change intervention evaluations

NARCIS (Netherlands)

Abraham, C.; Johnson, B.T.; de Bruin, M.; Luszczynska, A.

2014-01-01

Many behavior change interventions for the prevention and treatment of HIV have been evaluated, but suboptimal reporting of evaluations hinders the accumulation of evidence and the replication of interventions. In this article, we address 4 practices contributing to this problem. First, detailed

Use of the hCONSORT criteria as a reporting standard for herbal interventions for common dermatoses: a systematic review.

Science.gov (United States)

Ornelas, J; Routt, E; Kallis, P; Lev-Tov, H

2018-04-01

The use of complementary and alternative medicine (CAM) is increasing in Western countries, including in the area of dermatology. However, Western healthcare providers have not integrated CAM into regular practice owing to a lack of reliable data supporting its use. To encourage high-quality research related to the use of CAM and specifically herbal interventions, the CONsolidated Standards Of Reporting Trials (CONSORT) extension criteria on reporting herbal interventions (hCONSORT) were published in 2006. To evaluate the adherence of randomized controlled trials (RCTs) investigating herbal interventions for acne, atopic dermatitis (AD) and psoriasis to the hCONSORT criteria. A comprehensive search of the PubMed, Embase and Cochrane Library databases was conducted. RCTs published between 2009 and 2014 assessing therapeutic outcomes of plant-based interventions for acne, AD or psoriasis were included. Investigators determined the number of unique hCONSORT criteria satisfied per report. anova was used to examine differences in scores by disease entity. The vast majority of reviewed studies reported reports based on language and lack of assessment of overall adherence to CONSORT criteria. Our data indicate lack of adherence to hCONSORT extension criteria. Adherence to hCONSORT guidelines should be encouraged in order to provide high-quality reporting of research on herbal interventions in dermatology. Doing so may ease the integration of CAM into conventional medical practice and provide actionable data to providers. © 2017 British Association of Dermatologists.

The effectiveness of self-management support interventions for men with long-term conditions: a systematic review and meta-analysis.

Science.gov (United States)

Galdas, Paul; Fell, Jennifer; Bower, Peter; Kidd, Lisa; Blickem, Christian; McPherson, Kerri; Hunt, Kate; Gilbody, Simon; Richardson, Gerry

2015-03-20

To assess the effectiveness of self-management support interventions in men with long-term conditions. A quantitative systematic review with meta-analysis. The Cochrane Database of Systematic Reviews was searched to identify published reviews of self-management support interventions. Relevant reviews were screened to identify randomised controlled trials (RCTs) of self-management support interventions conducted in men alone, or which analysed the effects of interventions by sex. Data on relevant outcomes, patient populations, intervention type and study quality were extracted. Quality appraisal was conducted using the Cochrane Risk of Bias Tool. Meta-analysis was conducted to compare the effects of interventions in men, women, and mixed-sex sub-groups. 40 RCTs of self-management support interventions in men, and 20 eligible RCTs where an analysis by sex was reported, were included in the review. Meta-analysis suggested that physical activity, education, and peer support-based interventions have a positive impact on quality of life in men. However, there is currently insufficient evidence to make strong statements about whether self-management support interventions show larger, similar or smaller effects in men compared with women and mixed-sex groups. Clinicians may wish to consider whether certain types of self-management support (eg, physical activity, education, peer support) are particularly effective in men, although more research is needed to fully determine and explore this. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services.

Science.gov (United States)

Bonell, Chris; Moore, Graham; Warren, Emily; Moore, Laurence

2018-04-19

We have previously proposed that trials of social interventions can be done within a "realist" research paradigm. Critics have countered that such trials are irredeemably positivist and asked us to explain our philosophical position. We set out to explore what is meant by positivism and whether trials adhere to its tenets (of necessity or in practice) via a narrative literature review of social science and philosophical discussions of positivism, and of the trials literature and three case studies of trials. The philosophical literature described positivism as asserting: (1) the epistemic primacy of sensory information; (2) the requirement that theoretical terms equate with empirical terms; (3) the aim of developing universal laws; and (4) the unity of method between natural and social sciences. Regarding (1), it seems that rather than embodying the epistemic primacy of sensory data, randomised controlled trials (RCTs) of social interventions in health embrace an anti-positivist approach aiming to test hypotheses derived deductively from prior theory. Considering (2), while some RCTs of social interventions appear to limit theorisation to concepts with empirical analogues, others examine interventions underpinned by theories engaging with mechanisms and contextual contingencies not all of which can be measured. Regarding (3), while some trialists and reviewers in the health field do limit their role to estimating statistical trends as a mechanistic form of generalisation, this is not an inevitable feature of RCT-based research. Trials of social interventions can instead aim to generalise at the level of theory which specifies how mechanisms are contingent on context. In terms of (4), while RCTs are used to examine biomedical as well as social interventions in health, RCTs of social interventions are often distinctive in using qualitative analyses of data on participant accounts to examine questions of meaning and agency not pursued in the natural sciences. We

Efficacy and safety of pharmacological interventions in second- or later-line treatment of patients with advanced soft tissue sarcoma: a systematic review

International Nuclear Information System (INIS)

Sharma, Sheetal; Takyar, Shweta; Manson, Stephanie C; Powell, Sarah; Penel, Nicolas

2013-01-01

Current guidelines recommend anthracycline-based chemotherapy primarily with doxorubicin either as monotherapy or in combination with ifosfamide as the first-line treatment for most advanced STS subtypes. Therapeutic options after failure of doxorubicin and/or ifosfamide are limited. This study aimed to comprehensively review available data on the activity and safety of interventions in second- or later-line treatment of advanced STS. Electronic literature databases (Embase ® , MEDLINE ® , MEDLINE ® In-Process, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews) were searched from 1980 to 01 March 2012 to identify randomised controlled trials (RCTs) and non-randomised studies (both prospective and retrospective) evaluating pharmacological interventions in patients with advanced STS pre-treated with anthracycline- and/or ifosfamide-based therapy. The review identified six RCTs (one phase III and five phase II trials) and 94 non-randomised studies. Based on the primary trial endpoints, RCTs demonstrated favourable efficacy for pazopanib over placebo (PFS: 4.6 months vs. 1.6 months), gemcitabine plus dacarbazine over dacarbazine monotherapy (3-month PFS rate: 54.2% vs. 35.2%), and trabectedin 3-weekly schedule over weekly schedule (TTP: 3.7 months vs. 2.3 months. The non-randomised studies demonstrated heterogeneity in efficacy and safety results. Across the RCTs, pazopanib over placebo, gemcitabine-dacarbazine over dacarbazine, and trabectedin 3-weekly over weekly regimen clearly demonstrated a PFS advantage in the second- and later-line treatment of advanced STS. With only one phase III trial in this setting, there is a clear need for additional comparative trials to better understand the risk: benefit ratios of available agents and combinations

Mind-body interventions for vasomotor symptoms in healthy menopausal women and breast cancer survivors. A systematic review.

Science.gov (United States)

Stefanopoulou, Evgenia; Grunfeld, Elizabeth Alice

2017-09-01

Mind-body therapies are commonly recommended to treat vasomotor symptoms, such as hot flushes and night sweats (HFNS). The purpose of this systematic review was to evaluate the available evidence to date for the efficacy of different mind-body therapies to alleviate HFNS in healthy menopausal women and breast cancer survivors. Randomized controlled trials (RCTs) were identified using seven electronic search engines, direct searches of specific journals and backwards searches through reference lists of related publications. Outcome measures included HFNS frequency and/or severity or self-reported problem rating at post-treatment. The methodological quality of all studies was systematically assessed using predefined criteria. Twenty-six RCTs met the inclusion criteria. Interventions included yoga (n = 5), hypnosis (n = 3), mindfulness (n = 2), relaxation (n = 7), paced breathing (n = 4), reflexology (n = 1) and cognitive behavioural therapy (CBT) (n = 4). Findings were consistent for the effectiveness of CBT and relaxation therapies for alleviating troublesome vasomotor symptoms. For the remaining interventions, although some trials indicated beneficial effects (within groups) at post-treatment and/or follow up, between group findings were mixed and overall, methodological differences across studies failed to provide convincing supporting evidence. Collectively, findings suggest that interventions that include breathing and relaxation techniques, as well as CBT, can be beneficial for alleviating vasomotor symptoms. Additional large, methodologically rigorous trials are needed to establish the efficacy of interventions on vasomotor symptoms, examine long-term outcomes and understand how they work.

Hypnosis for induction of labour.

Science.gov (United States)

Nishi, Daisuke; Shirakawa, Miyako N; Ota, Erika; Hanada, Nobutsugu; Mori, Rintaro

2014-08-14

Induction of labour using pharmacological and mechanical methods can increase complications. Complementary and alternative medicine methods including hypnosis may have the potential to provide a safe alternative option for the induction of labour. However, the effectiveness of hypnosis for inducing labour has not yet been fully evaluated. To assess the effect of hypnosis for induction of labour compared with no intervention or any other interventions. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2014), handsearched relevant conference proceedings, contacted key personnel and organisations in the field for published and unpublished references. All published and unpublished randomised controlled trials (RCTs) and cluster-RCTs of acceptable quality comparing hypnosis with no intervention or any other interventions, in which the primary outcome is to assess whether labour was induced. Two review authors assessed the one trial report that was identified (but was subsequently excluded). No RCTs or cluster-RCTs were identified from the search strategy. There was no evidence available from RCTs to assess the effect of hypnosis for induction of labour. Evidence from RCTs is required to evaluate the effectiveness and safety of this intervention for labour induction. As hypnosis may delay standard care (in case standard care is withheld during hypnosis), its use in induction of labour should be considered on a case-by-case basis.Future RCTs are required to examine the effectiveness and safety of hypnotic relaxation for induction of labour among pregnant women who have anxiety above a certain level. The length and timing of the intervention, as well as the staff training required, should be taken into consideration. Moreover, the views and experiences of women and staff should also be included in future RCTs.

Intervention Now to Eliminate Repeat Unintended Pregnancy in Teenagers (INTERUPT): a systematic review of intervention effectiveness and cost-effectiveness, and qualitative and realist synthesis of implementation factors and user engagement.

Science.gov (United States)

Whitaker, Rhiannon; Hendry, Maggie; Aslam, Rabeea'h; Booth, Andrew; Carter, Ben; Charles, Joanna M; Craine, Noel; Tudor Edwards, Rhiannon; Noyes, Jane; Ives Ntambwe, Lupetu; Pasterfield, Diana; Rycroft-Malone, Jo; Williams, Nefyn

2016-02-01

Portfolio and Index to THESES. Searches were conducted in May 2013 and updated in June 2014. In addition, we conducted a systematic search of Google (Google Inc., Mountain View, CA, USA) in January 2014. Database searches were guided by an advisory group of stakeholders. To address the topic's complexities, we used a structured, innovative and iterative approach combining methods tailored to each evidence stream. Quantitative data (effectiveness, cost-effectiveness, risk factors and effect modifiers) were synthesised with reference to Cochrane guidelines for evaluating evidence on public health interventions. Qualitative evidence addressing facilitators of and barriers to the uptake of interventions, experience and acceptability of interventions was synthesised thematically. We applied the principles of realist synthesis to uncover theories and mechanisms underpinning interventions (what works, for whom and in what context). Finally, we conducted an overarching narrative of synthesis of evidence and gathered service user feedback. We identified 8664 documents initially, and 816 in repeat searches. We filtered these to 12 randomised controlled trials (RCTs), four quasi-RCTs, 10 qualitative studies and 53 other quantitative studies published between 1996 and 2012. None of the RCTs was based in the UK. The RCTs evaluated an emergency contraception programme and psychosocial interventions. We found no evidence for effectiveness with regard to condom use, contraceptive use or rates of unprotected sex or use of birth control. Our primary outcome was repeat conception rate: the event rate was 132 of 308 (43%) in the intervention group versus 140 of 289 (48%) for the control goup, with a non-significant risk ratio (RR) of 0.92 [95% confidence interval (CI) 0.78 to 1.08]. Four studies reported subsequent birth rates: 29 of 237 (12%) events for the intervention arm versus 46 out of 224 (21%) for the control arm, with a RR of 0.60 (95% CI 0.39 to 0.93). Many repeat conceptions

Comparison of multiple interventions for older adults with Alzheimer disease or mild cognitive impairment: A PRISMA-compliant network meta-analysis.

Science.gov (United States)

Liang, Jing-Hong; Xu, Yong; Lin, Lu; Jia, Rui-Xia; Zhang, Hong-Bo; Hang, Lei

2018-05-01

The increasing prevalence of Alzheimer disease (AD) emphasizes the need for effective treatments. Both pharmacological therapies such as nutrition therapy (NT) and nonpharmacologic therapies including traditional treatment or personalized treatment (e.g., physical exercise, music therapy, computerized cognitive training) have been approved for the treatment of AD or mild cognitive impairment (MCI) in numerous areas. The aim of this study was to compare 4 types of interventions, physical exercise (PE), music therapy (MT), computerized cognitive training (CCT), and NT, in older adults with mild to moderate AD or MCI and identify the most effective intervention for their cognitive function. We used a system of search strategies to identify relevant studies and include randomized controlled trials (RCTs), placebo-controlled trials evaluating the efficacy and safety of 4 interventions in patients with AD or MCI. We updated the relevant studies which were published before March 2017 as a full-text article. Using Bayesian network meta-analysis (NMA), we ranked cognitive ability based objectively on Mini-Mental State Examination (MMSE), and assessed neuropsychiatric symptoms based on Neuropsychiatric Inventory (NPI). Pairwise and network meta-analyses were sequentially performed for efficacy and safety of intervention compared to control group through RCTs included. We included 17 RCTs. Fifteen trials (n = 1747) were pooled for cognition and no obvious heterogeneity was found (I = 21.7%, P = .212) in NMA, the mean difference (MD) of PE (MD = 2.1, confidence interval [CI]: 0.44-3.8) revealed that PE was significantly efficacious in the treatment group in terms of MMSE. Five trials (n = 660) assessed neuropsychiatric symptoms with an obvious heterogeneity (I = 61.6%, P = .034), the MD of CCT (MD = -7.7, CI: -14 to -2.4), revealing that CCT was significantly efficacious in NPI. As the first NMA comparing different interventions for AD and MCI

Educational interventions to improve quality of life in people with chronic inflammatory skin diseases: systematic reviews of clinical effectiveness and cost-effectiveness.

Science.gov (United States)

Pickett, Karen; Loveman, Emma; Kalita, Neelam; Frampton, Geoff K; Jones, Jeremy

2015-10-01

Inflammatory skin diseases include a broad range of disorders. For some people, these conditions lead to psychological comorbidities and reduced quality of life (QoL). Patient education is recommended in the management of these conditions and may improve QoL. To assess the clinical effectiveness and cost-effectiveness of educational interventions to improve health-related quality of life (HRQoL) in people with chronic inflammatory skin diseases. Twelve electronic bibliographic databases, including The Cochrane Library, MEDLINE and EMBASE, were searched to July 2014. Bibliographies of retrieved papers were searched and an Advisory Group contacted. Systematic reviews were conducted following standard methodologies. Clinical effectiveness studies were included if they were undertaken in people with a chronic inflammatory skin condition. Educational interventions that aimed to, or could, improve HRQoL were eligible. Studies were required to measure HRQoL, and other outcomes such as disease severity were also included. Randomised controlled trials (RCTs) or controlled clinical trials were eligible. For the review of cost-effectiveness, studies were eligible if they were full economic evaluations, cost-consequence or cost analyses. Seven RCTs were included in the review of clinical effectiveness. Two RCTs focused on children with eczema and their carers. Five RCTs were in adults. Of these, two were of people with psoriasis, one was of people with acne and two were of people with a range of conditions. There were few similarities in the interventions (e.g. the delivery mode, the topics covered, the duration of the education), which precluded any quantitative synthesis. Follow-up ranged from 4 weeks to 12 months, samples sizes were generally small and, overall, the study quality was poor. There appeared to be positive effects on HRQoL in participants with psoriasis in one trial, but no difference between groups in another trial in which participants had less severe

Interventions for replacing missing teeth: treatment of peri-implantitis.

Science.gov (United States)

Esposito, Marco; Grusovin, Maria Gabriella; Worthington, Helen V

2012-01-18

One of the key factors for the long-term success of oral implants is the maintenance of healthy tissues around them. Bacterial plaque accumulation induces inflammatory changes in the soft tissues surrounding oral implants and it may lead to their progressive destruction (peri-implantitis) and ultimately to implant failure. Different treatment strategies for peri-implantitis have been suggested, however it is unclear which are the most effective. To identify the most effective interventions for treating peri-implantitis around osseointegrated dental implants. We searched the Cochrane Oral Health Group's Trials Register, CENTRAL, MEDLINE and EMBASE. Handsearching included several dental journals. We checked the bibliographies of the identified randomised controlled trials (RCTs) and relevant review articles for studies outside the handsearched journals. We wrote to authors of all identified RCTs, to more than 55 dental implant manufacturers and an Internet discussion group to find unpublished or ongoing RCTs. No language restrictions were applied. The last electronic search was conducted on 9 June 2011. All RCTs comparing agents or interventions for treating peri-implantitis around dental implants. Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted in duplicate and independently by two review authors. We contacted the authors for missing information. Results were expressed as random-effects models using mean differences for continuous outcomes and risk ratios for dichotomous outcomes with 95% confidence intervals (CI). Heterogeneity was to be investigated including both clinical and methodological factors. Fifteen eligible trials were identified, but six were excluded. The following interventions were compared in the nine included studies: different non-surgical interventions (five trials); adjunctive treatments to non-surgical interventions (one trial); different surgical interventions (two trials

The Effects of Feedback on Adherence to Treatment: A Systematic Review and Meta-analysis of RCTs.

Science.gov (United States)

Seewoodharry, Mansha D; Maconachie, Gail D E; Gillies, Clare L; Gottlob, Irene; McLean, Rebecca J

2017-08-01

The aim of this systematic review is to determine whether providing feedback, guided by subjective or objective measures of adherence, improves adherence to treatment. Data sources included MEDLINE, Embase, CINAHL, and PsycINFO, and reference lists of retrieved articles. Only RCTs comparing the effect of feedback on adherence outcome were included. Three independent reviewers extracted data for all potentially eligible studies using an adaptation of the Cochrane Library data extraction sheet. The primary outcome, change in adherence, was obtained by measuring the difference between adherence at baseline visit (prior to feedback) and at the last visit (post-feedback). Twenty-four studies were included in the systematic review, and 16 found a significant improvement in adherence in the intervention group (change in adherence range, -13% to +22%), whereas adherence worsened in the control group (change in adherence range, -32% to 10.2%). Meta-analysis included six studies, and the pooled effect showed that mean percentage adherence increased by 10.02% (95% CI=3.15%, 16.89%, p=0.004) more between baseline and follow-up in the intervention groups compared with control groups. Meta-regression confirmed that study quality, form of monitoring adherence, delivery of feedback, or study duration did not influence effect size. Feedback guided by objective or subjective measures of adherence improves adherence and, perhaps more importantly, prevents worsening of adherence over time even when only small absolute improvements in adherence were noted. Increased use of feedback to improve treatment adherence has the potential to reduce avoidable healthcare costs caused by non-adherence. Copyright © 2017 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

The effect of blinding on estimates of mortality in randomised clinical trials of intensive care interventions

DEFF Research Database (Denmark)

Anthon, Carl Thomas; Granholm, Anders; Perner, Anders

2017-01-01

INTRODUCTION: Evidence exists that unblinded randomised clinical trials (RCTs) overestimate intervention effects compared with blinded RCTs. It has been suggested that this is less pronounced for objective (ie, not subject to interpretation) outcome measures, including mortality. This may not apply......(s). For each intervention, we will compare summary mortality effect estimates in blinded versus unblinded trials. ETHICS AND DISSEMINATION: This research does not require ethical approval as we will use summary data from trials already approved by relevant ethical institutions. We will report the results...... in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement and submit the final paper to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: PROSPERO, registration number: CRD42017056212....

Terlipressin versus placebo or no intervention for people with cirrhosis and hepatorenal syndrome

DEFF Research Database (Denmark)

Allegretti, Andrew S.; Israelsen, Mads; Krag, Aleksander

2017-01-01

) and abdominal pain (RR 1.54, 95% CI 0.97 to 2.43; 294 participants; low-quality evidence). We identified one ongoing trial on terlipressin versus placebo in participants with cirrhosis, ascites, and hepatorenal syndrome type 1. Three RCTs reported funding from a pharmaceutical company. The remaining trials did...... version of this systematic review found a potential beneficial effect of terlipressin on mortality and renal function in people with cirrhosis and hepatorenal syndrome. Objectives To assess the beneficial and harmful effects of terlipressin versus placebo/no intervention for people with cirrhosis...... until 21 November 2016. Selection criteria Randomised clinical trials (RCTs) involving participantswith cirrhosis and type 1 or type 2 hepatorenal syndrome allocated to terlipressin versus placebo or no intervention. We allowed co-administration with albumin administered to both comparison groups. Data...

The Effectiveness of Cognitive Bias Modification Interventions for Substance Addictions: A Meta-Analysis

DEFF Research Database (Denmark)

Cristea, Ioana; Kok, Robin; Cuijpers, Pim

2016-01-01

Background and Aims Cognitive bias modification (CBM) interventions, presumably targeting automatic processes, are considered particularly promising for addictions. We conducted a meta-analysis examining randomized controlled trials (RCTs) of CBM for substance addiction outcomes. Methods Studies...... were identified through systematic searches in bibliographical databases. We included RCTs of CBM interventions, alone or in combination with other treatments, for any type of addiction. We examined trial risk of bias, publication bias and possible moderators. Effects sizes were computed for post......-test and follow-up, using a random-effects model. We grouped outcome measures and reported results for addiction (all related measures), craving and cognitive bias. Results We identified 25 trials, 18 for alcohol problems, and 7 for smoking. At post-test, there was no significant effect of CBM for addiction, g...

Effect of comprehensive oncogenetics training interventions for general practitioners, evaluated at multiple performance levels.

Directory of Open Access Journals (Sweden)

Elisa J F Houwink

Full Text Available General practitioners (GPs are increasingly called upon to identify patients at risk for hereditary cancers, and their genetic competencies need to be enhanced. This article gives an overview of a research project on how to build effective educational modules on genetics, assessed by randomized controlled trials (RCTs, reflecting the prioritized educational needs of primary care physicians. It also reports on an ongoing study to investigate long-term increase in genetic consultation skills (1-year follow-up and interest in and satisfaction with a supportive website on genetics among GPs. Three oncogenetics modules were developed: an online Continuing Professional Development (G-eCPD module, a live genetic CPD module, and a "GP and genetics" website (huisartsengenetica.nl providing further genetics information applicable in daily practice. Three assessments to evaluate the effectiveness (1-year follow-up of the oncogenetic modules were designed: 1.An online questionnaire on self-reported genetic competencies and changes in referral behaviour, 2.Referral rates from GPs to clinical genetics centres and 3.Satisfaction questionnaire and visitor count analytics of supportive genetics website. The setting was Primary care in the Netherlands and three groups of study participants were included in the reported studies:. Assessment 1. 168 GPs responded to an email invitation and were randomly assigned to an intervention or control group, evaluating the G-eCPD module (n = 80 or the live module (n = 88. Assessment 2. Referral rates by GPs were requested from the clinical genetics centres, in the northern and southern parts of the Netherlands (Amsterdam and Maastricht, for the two years before (2010 [n = 2510] and 2011 [n = 2940] and the year after (2012 [n = 2875] launch of the oncogenetics CPD modules and the website. Assessment 3. Participants of the website evaluation were all recruited online. When they visited the website during the month of February

Interventions to improve medication adherence among Chinese patients with hypertension: a systematic review and meta-analysis of randomized controlled trails.

Science.gov (United States)

Xu, Rixiang; Xie, Xuefeng; Li, Shuting; Chen, Xiaoyu; Wang, Sheng; Hu, Chengyang; Lv, Xiongwen

2018-04-25

A systematic review and meta-analysis of randomized controlled trials (RCTs) were performed to understand the effectiveness of medication adherence (MA) interventions among Chinese patients with hypertension. A literature search was conducted with three English databases (PubMed, Web of Science and Embase) and three Chinese databases (China National Knowledge Infrastructure, Wanfang and VIP Database for Chinese Technical Periodicals) for the period from 1970 to October 2017. Only both RCTs with a minimum of 10 participants in each intervention group and Chinese patients with hypertension as participants were included. A random-effects model was applied to calculate pooled effect sizes with 95% CI. Subgroup analysis was conducted to identify potential sources of heterogeneity from duration of intervention, type of intervener, methods of intervention and sites of intervention. Funnel plots and Egger's test were used to evaluate for publication bias. A total of 48 studies met criteria for the meta-analysis, including 14 568 participants, testing 57 independent comparisons. Overall, the effect size revealed that interventions significantly improved MA (pooled relative risk = 1.59, 95% CI: 1.43 to 1.78; pooled Cohen's d = 1.42, 95% CI: 0.976 to 1.876). Interventions were found to significantly reduce blood pressure (BP) (systolic BP: Cohen's d = -0.85, 95% CI: -1.11 to -0.60 and diastolic BP: Cohen's d = -0.73, 95% CI: -1.00 to -0.46). Longer duration of intervention gave better effectiveness. Physician as interventionist, regular follow-up visits and interventions conducted at a hospital were associated with better effectiveness. Adherence interventions improve MA and reduce uncontrolled BP among Chinese patients with hypertension. In the future, investigators should adopt a skill set to address the problem of poor MA. © 2018 Royal Pharmaceutical Society.

Effect of Low-Fat vs. Other Diet Interventions on Long-Term Weight Change in Adults: A Systematic Review and Meta-Analysis

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Tobias, Deirdre K.; Chen, Mu; Manson, JoAnn E.; Ludwig, David S.; Willett, Walter; Hu, Frank B.

2015-01-01

Background The effectiveness of low-fat diets for long-term weight loss has been debated for decades, with dozens of randomized trials (RCTs) and recent reviews giving mixed results. Methods We conducted a random effects meta-analysis of RCTs to estimate the long-term effect of low-fat vs. higher fat dietary interventions on weight loss. Our search included RCTs conducted in adult populations reporting weight change outcomes at ≥1 year, comparing low-fat with higher fat interventions, published through July 2014. The primary outcome measure was mean difference in weight change between interventions. Findings Fifty-three studies met inclusion criteria representing 68,128 participants. In the setting of weight loss trials, low-carbohydrate interventions led to significantly greater weight loss than low-fat interventions (n comparisons=18; weighted mean difference [WMD]=1.15 kg, 95% CI=0.52 to 1.79; I2=10%). Low-fat did not lead to differences in weight change compared with other moderate fat weight loss interventions (n=19; WMD=0.36, 95% CI=-0.66 to 1.37; I2=82%), and were superior only when compared with “usual diet” (n=8; WMD=-5.41, 95% CI=-7.29 to −3.54; I2=68%). Similarly, non-weight loss trials and weight maintenance trials, for which there were no low-carbohydrate comparisons, had similar effects for low-fat vs moderate fat interventions, and were superior compared with “usual diet”. Weight loss trials achieving a greater difference in fat intake at follow-up significantly favored the higher fat dietary interventions, as indicated by difference of ≥5% of calories from fat (n=18; WMD=1.04, 95% CI=0.06 to 2.03; I2=78%) or by difference in change serum triglycerides of ≥5 mg/dL (n=17; WMD=1.38, 95% CI=0.50 to 2.25; I2=62%). Interpretation These findings suggest that the long-term effect of low-fat diets on body weight depends on the intensity of intervention in the comparison group. When compared to dietary interventions of similar intensity

Behaviour change techniques used in digital interventions to reduce excessive alcohol consumption

Directory of Open Access Journals (Sweden)

David Crane

2015-10-01

Full Text Available Background: Excessive alcohol consumption is a leading contributor to the global burden of disease. A large number of digital interventions have been developed to help people reduce their consumption. Coding interventions to assess the behaviour change techniques (BCTs they contain may advance understanding of the active ingredients that contribute to intervention effectiveness. Aim: To assess the extent to which BCTs are included in digital interventions to reduce alcohol consumption. Methods: A search of databases including MEDLINE, PsycINFO and the Cochrane Library identified 53 interventions to reduce alcohol consumption evaluated in RCTs. Intervention content was coded for BCTs according to the BCT Taxonomy (v1 using an established method. Results: There were 72 experimental arms in the 53 included studies. The most frequently used BCTs were: ‘Feedback on behaviour’ (70.8%, n=51, ‘Social comparison’ (68.1%, n=49, ‘Feedback on outcomes of behaviour (52.8%, n=38, ‘Social support’ (52.8%, n=38, and ‘Information about social and environmental consequences’ (50.0%, n=36. Of the ninety-three possible BCTs that could have been used, 15 were used in more than 20% of arms, 53 were used at least once and 40 were never used. The mean number of BCTs used was 7.8 (SD=5.6. Conclusions: Digital alcohol interventions have used a broad range of BCTs. However, many BCTs were used infrequently and the evaluations have not been set up to evaluate the effectiveness of individual BCTs or clusters of BCTs.

Effects of Exercise Interventions and Physical Activity Behavior on Cancer Related Cognitive Impairments: A Systematic Review

Directory of Open Access Journals (Sweden)

Philipp Zimmer

2016-01-01

Full Text Available This systematic review analyzes current data on effects of exercise interventions and physical activity behavior on objective and subjective cancer related cognitive impairments (CRCI. Out of the 19 studies which met all inclusion criteria, five RCTs investigated rodents, whereas the other 14 trials explored humans and these included six RCTs, one controlled trial, two prospective noncontrolled trials, one case series, one observational study, and three cross-sectional studies. The results from animal models revealed positive effects of exercise during and after chemotherapy or radiation on structural alterations of the central nervous system, physiological as well as neuropsychological outcomes. The overall study quality in patient studies was poor. The current data on intervention studies showed preliminary positive effects of Asian-influenced movement programs (e.g., Yoga with benefits on self-perceived cognitive functions as well as a reduction of chronic inflammation for breast cancer patients in the aftercare. Exercise potentially contributes to the prevention and rehabilitation of CRCI. Additional RCTs with standardized neuropsychological assessments and controlling for potential confounders are needed to confirm and expand preliminary findings.

The Breast Health Intervention Evaluation Study

National Research Council Canada - National Science Library

Blumenthal, Daniel

1997-01-01

The Breast Health Intervention Evaluation (BRIE) Study will evaluate the relative effectiveness of three different approaches to breast health messages--a fear appeal, a positive affect appeal, and an affectively neutral, cognitive appeal...

Interventions for encouraging sexual behaviours intended to prevent cervical cancer

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Shepherd, Jonathan P; Frampton, Geoff K; Harris, Petra

2014-01-01

Background Human papillomavirus (HPV) is the key risk factor for cervical cancer. Continuing high rates of HPV and other sexually transmitted infections (STIs) in young people demonstrate the need for effective behavioural interventions. Objectives To assess the effectiveness of behavioural interventions for young women to encourage safer sexual behaviours to prevent transmission of STIs (including HPV) and cervical cancer. Search methods Systematic literature searches were performed on the following databases: Cochrane Central Register of Controlled Trials (CENTRAL Issue 4, 2009) Cochrane Gynaecological Cancer Review Group (CGCRG) Specialised Register, MEDLINE, EMBASE, CINAHL, PsychINFO, Social Science Citation Index and Trials Register of Promoting Health Interventions (TRoPHI) up to the end of 2009. All references were screened for inclusion against selection criteria. Selection criteria Randomised controlled trials (RCTs) of behavioural interventions for young women up to the age of 25 years that included, amongst other things, information provision about the transmission and prevention of STIs. Trials had to measure behavioural outcomes (e.g. condom use) and/or biological outcomes (e.g. incidence of STIs, cervical cancer). Data collection and analysis A narrative synthesis was conducted. Meta-analysis was not considered appropriate due to heterogeneity between the interventions and trial populations. Main results A total of 5271 references were screened and of these 23 RCTs met the inclusion criteria. Most were conducted in the USA and in health-care clinics (e.g. family planning). The majority of interventions provided information about STIs and taught safer sex skills (e.g. communication), occasionally supplemented with provision of resources (e.g. free sexual health services). They were heterogeneous in duration, contact time, provider, behavioural aims and outcomes. A variety of STIs were addressed including HIV and chlamydia. None of the trials explicitly

Health behaviour change interventions for couples: A systematic review.

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Arden-Close, Emily; McGrath, Nuala

2017-05-01

Partners are a significant influence on individuals' health, and concordance in health behaviours increases over time in couples. Several theories suggest that couple-focused interventions for health behaviour change may therefore be more effective than individual interventions. A systematic review of health behaviour change interventions for couples was conducted. Systematic search methods identified randomized controlled trials (RCTs) and non-randomized interventions of health behaviour change for couples with at least one member at risk of a chronic physical illness, published from 1990-2014. We identified 14 studies, targeting the following health behaviours: cancer prevention (6), obesity (1), diet (2), smoking in pregnancy (2), physical activity (1) and multiple health behaviours (2). In four out of seven trials couple-focused interventions were more effective than usual care. Of four RCTs comparing a couple-focused intervention to an individual intervention, two found that the couple-focused intervention was more effective. The studies were heterogeneous, and included participants at risk of a variety of illnesses. In many cases the intervention was compared to usual care for an individual or an individual-focused intervention, which meant the impact of the couplebased content could not be isolated. Three arm studies could determine whether any added benefits of couple-focused interventions are due to adding the partner or specific content of couple-focused interventions. Statement of contribution What is already known on this subject? Health behaviours and health behaviour change are more often concordant across couples than between individuals in the general population. Couple-focused interventions for chronic conditions are more effective than individual interventions or usual care (Martire, Schulz, Helgeson, Small, & Saghafi, ). What does this study add? Identified studies targeted a variety of health behaviours, with few studies in any one area. Further

Theories underlying health promotion interventions among cancer survivors.

Science.gov (United States)

Pinto, Bernardine M; Floyd, Andrea

2008-08-01

To review the theories that have been the basis for randomized controlled trials (RCTs) promoting health behavior change among adults diagnosed and treated for cancer. Electronic databases and recent review papers. Several theories have been used in intervention development: Transtheoretical Model, Motivational Interviewing, Social Learning and Social Cognitive Theory, Theory of Planned Behavior, and Cognitive Behavioral Theory. There is support for the efficacy of some of these interventions. However, there has been limited assessment of theory-based constructs and examination of the mediational role of theoretical constructs in intervention efficacy. There is a need to apply theory in the development of interventions to assess the effects of the intervention on the constructs and to conduct mediational tests of these constructs.

Methods for Process Evaluation of Work Environment Interventions

DEFF Research Database (Denmark)

Fredslund, Hanne; Strandgaard Pedersen, Jesper

2004-01-01

or management perceptions and actions in implementing any intervention and their influence on the overall result of the intervention' (Nytrø, Saksvik, Mikkelsen, Bohle, and Quinlan, 2000). Process evaluation can be used to a) provide feedback for improving interventions, b) interpret the outcomes of effect......In recent years, intervention studies have become increasingly popular within occupational health psychology. The vast majority of such studies have focused on interventions themselves and their effects on the working environment and employee health and well-being. Few studies have focused on how...... the context and processes surrounding the intervention may have influenced the outcomes (Hurrell and Murphy, 1996). Thus, there is still relatively little published research that provides us with information on how to evaluate such strategies and processes (Saksvik, Nytrø, Dahl-Jørgensen, and Mikkelsen, 2002...

Interventions for replacing missing teeth: Antibiotics in dental implant placement to prevent complications: Evidence summary of Cochrane review

OpenAIRE

Jayaraman, Srinivasan

2015-01-01

The failure of dental implant can occurs at the preoperative planning stage, at the surgical stage, and at the postoperative stage. The success of this treatment can be increased if the clinical implant practice guidelines are prepared based on the recommendations from the highest level of research evidence (i.e.,) from systematic review of randomized controlled trials (RCTs) with meta-analysis. The Cochrane reviews of interventions are basically systematic reviews of RCTs with meta-analysis ...

Interventions to prevent occupational noise-induced hearing loss: A Cochrane systematic review

Science.gov (United States)

Verbeek, Jos H.; Kateman, Erik; Morata, Thais C.; Dreschler, Wouter A.; Mischke, Christina

2015-01-01

Objective To assess the effectiveness of interventions for preventing occupational noise exposure or hearing loss compared to no intervention or alternative interventions. Design We searched biomedical databases up to 25 January 2012 for randomized controlled trials (RCT), controlled before-after studies and interrupted time-series of hearing loss prevention among workers exposed to noise. Study sample We included 19 studies with 82 794 participants evaluating effects of hearing loss prevention programs (HLPP). The overall quality of studies was low to very low, as rated using the GRADE approach. Results One study of stricter legislation showed a favorable effect on noise levels. Three studies, of which two RCTs, did not find an effect of a HLPP. Four studies showed that better use of hearing protection devices in HLPPs decreased the risk of hearing loss. In four other studies, workers in a HLPP still had a 0.5 dB greater hearing loss at 4 kHz (95% CI – 0.5 to 1.7) than non-exposed workers. In two similar studies there was a substantial risk of hearing loss in spite of a HLPP. Conclusions Stricter enforcement of legislation and better implementation of HLPPs can reduce noise levels in workplaces. Better evaluations of technical interventions and long-term effects are needed. PMID:24564697

Interventions to prevent occupational noise-induced hearing loss: a Cochrane systematic review.

Science.gov (United States)

Verbeek, Jos H; Kateman, Erik; Morata, Thais C; Dreschler, Wouter A; Mischke, Christina

2014-03-01

To assess the effectiveness of interventions for preventing occupational noise exposure or hearing loss compared to no intervention or alternative interventions. We searched biomedical databases up to 25 January 2012 for randomized controlled trials (RCT), controlled before-after studies and interrupted time-series of hearing loss prevention among workers exposed to noise. We included 19 studies with 82 794 participants evaluating effects of hearing loss prevention programs (HLPP). The overall quality of studies was low to very low, as rated using the GRADE approach. One study of stricter legislation showed a favorable effect on noise levels. Three studies, of which two RCTs, did not find an effect of a HLPP. Four studies showed that better use of hearing protection devices in HLPPs decreased the risk of hearing loss. In four other studies, workers in a HLPP still had a 0.5 dB greater hearing loss at 4 kHz (95% CI - 0.5 to 1.7) than non-exposed workers. In two similar studies there was a substantial risk of hearing loss in spite of a HLPP. Stricter enforcement of legislation and better implementation of HLPPs can reduce noise levels in workplaces. Better evaluations of technical interventions and long-term effects are needed.

Interventions for investigating and identifying the causes of stillbirth.

Science.gov (United States)

Wojcieszek, Aleena M; Shepherd, Emily; Middleton, Philippa; Gardener, Glenn; Ellwood, David A; McClure, Elizabeth M; Gold, Katherine J; Khong, Teck Yee; Silver, Robert M; Erwich, Jan Jaap Hm; Flenady, Vicki

2018-04-30

Identification of the causes of stillbirth is critical to the primary prevention of stillbirth and to the provision of optimal care in subsequent pregnancies. A wide variety of investigations are available, but there is currently no consensus on the optimal approach. Given their cost and potential to add further emotional burden to parents, there is a need to systematically assess the effect of these interventions on outcomes for parents, including psychosocial outcomes, economic costs, and on rates of diagnosis of the causes of stillbirth. To assess the effect of different tests, protocols or guidelines for investigating and identifying the causes of stillbirth on outcomes for parents, including psychosocial outcomes, economic costs, and rates of diagnosis of the causes of stillbirth. We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 May 2017). We planned to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs. We planned to include studies published as abstract only, provided there was sufficient information to allow us to assess study eligibility. We planned to exclude cross-over trials.Participants included parents (including mothers, fathers, and partners) who had experienced a stillbirth of 20 weeks' gestation or greater.This review focused on interventions for investigating and identifying the causes of stillbirth. Such interventions are likely to be diverse, but could include:* review of maternal and family history, and current pregnancy and birth history;* clinical history of present illness;* maternal investigations (such as ultrasound, amniocentesis, antibody screening, etc.);* examination of the stillborn baby (including full autopsy, partial autopsy or noninvasive components, such as magnetic resonance imaging (MRI), computerised tomography (CT) scanning, and radiography);* umbilical cord examination

Effects of preventive online mindfulness interventions on stress and mindfulness: A meta-analysis of randomized controlled trials

Directory of Open Access Journals (Sweden)

Wasantha P. Jayawardene, MD, PhD

2017-03-01

Full Text Available Empirical evidence suggested that mind-body interventions can be effectively delivered online. This study aimed to examine whether preventive online mindfulness interventions (POMI for non-clinical populations improve short- and long-term outcomes for perceived-stress (primary and mindfulness (secondary. Systematic search of four electronic databases, manuscript reference lists, and journal content lists was conducted in 2016, using 21 search-terms. Eight randomized controlled trials (RCTs evaluating effects of POMI in non-clinical populations with adequately reported perceived-stress and mindfulness measures pre- and post-intervention were included. Random-effects models utilized for all effect-size estimations with meta-regression performed for mean age and %females. Participants were volunteers (adults; predominantly female from academic, workplace, or community settings. Most interventions utilized simplified Mindfulness-Based Stress Reduction protocols over 2–12 week periods. Post-intervention, significant medium effect found for perceived-stress (g = 0.432, with moderate heterogeneity and significant, but small, effect size for mindfulness (g = 0.275 with low heterogeneity; highest effects were for middle-aged individuals. At follow-up, significant large effect found for perceived-stress (g = 0.699 with low heterogeneity and significant medium effect (g = 0.466 for mindfulness with high heterogeneity. No publication bias was found for perceived-stress; publication bias found for mindfulness outcomes led to underestimation of effects, not overestimation. Number of eligible RCTs was low with inadequate data reporting in some studies. POMI had substantial stress reduction effects and some mindfulness improvement effects. POMI can be a more convenient and cost-effective strategy, compared to traditional face-to-face interventions, especially in the context of busy, hard-to-reach, but digitally-accessible populations.

Workplace interventions for reducing sitting at work.

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Shrestha, Nipun; Kukkonen-Harjula, Katriina T; Verbeek, Jos H; Ijaz, Sharea; Hermans, Veerle; Bhaumik, Soumyadeep

2016-03-17

Office work has changed considerably over the previous couple of decades and has become sedentary in nature. Physical inactivity at workplaces and particularly increased sitting has been linked to increase in cardiovascular disease, obesity and overall mortality. To evaluate the effects of workplace interventions to reduce sitting at work compared to no intervention or alternative interventions. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, OSH UPDATE, PsycINFO, Clinical trials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal up to 2 June, 2015. We also screened reference lists of articles and contacted authors to find more studies to include. We included randomised controlled trials (RCTs), cluster-randomised controlled trials (cRCTs), and quasi-randomised controlled trials of interventions to reduce sitting at work. For changes of workplace arrangements, we also included controlled before-and-after studies (CBAs) with a concurrent control group. The primary outcome was time spent sitting at work per day, either self-reported or objectively measured by means of an accelerometer-inclinometer. We considered energy expenditure, duration and number of sitting episodes lasting 30 minutes or more, work productivity and adverse events as secondary outcomes. Two review authors independently screened titles, abstracts and full-text articles for study eligibility. Two review authors independently extracted data and assessed risk of bias. We contacted authors for additional data where required. We included 20 studies, two cross-over RCTs, 11 RCTs, three cRCTs and four CBAs, with a total of 2180 participants from high income nations. The studies evaluated physical workplace changes (nine studies), policy changes (two studies), information and counselling (seven studies) and interventions from multiple categories (two studies). One study had both physical

Current evidence for effectiveness of interventions for cubital tunnel syndrome, radial tunnel syndrome, instability, or bursitis of the elbow: a systematic review.

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Rinkel, Willem D; Schreuders, Ton A R; Koes, Bart W; Huisstede, Bionka M A

2013-12-01

To provide an evidence-based overview of the effectiveness of interventions for 4 nontraumatic painful disorders sharing the anatomic region of the elbow: cubital tunnel syndrome, radial tunnel syndrome, elbow instability, and olecranon bursitis. The Cochrane Library, PubMed, Embase, PEDro, and CINAHL were searched to identify relevant reviews and randomized clinical trials (RCTs). Two reviewers independently extracted data and assessed the quality of the methodology. A best-evidence synthesis was used to summarize the results. One systematic review and 6 RCTs were included. For the surgical treatment of cubital tunnel syndrome (1 review, 3 RCTs), comparing simple decompression with anterior ulnar nerve transposition, no evidence was found in favor of either one of these. Limited evidence was found in favor of medial epicondylectomy versus anterior transposition and for early postoperative therapy versus immobilization. No evidence was found for the effect of local steroid injection in addition to splinting. No RCTs were found for radial tunnel syndrome. For olecranon bursitis (1 RCT), limited evidence for effectiveness was found for methylprednisolone acetate injection plus naproxen. Concerning elbow instability, including 2 RCTs, one showed that nonsurgical treatment resulted in similar results compared with surgery, whereas the other found limited evidence for the effectiveness in favor of early mobilization versus 3 weeks of immobilization after surgery. In this review no, or at best, limited evidence was found for the effectiveness of nonsurgical and surgical interventions to treat painful cubital tunnel syndrome, radial tunnel syndrome, elbow instability, or olecranon bursitis. Well-designed and well-conducted RCTs are clearly needed in this field.

A systematic review and meta-analysis of comprehensive interventions for pre-school children with autism spectrum disorder (ASD).

Science.gov (United States)

Tachibana, Yoshiyuki; Miyazaki, Celine; Ota, Erika; Mori, Rintaro; Hwang, Yeonhee; Kobayashi, Eriko; Terasaka, Akiko; Tang, Julian; Kamio, Yoko

2017-01-01

There has an increasing number of published trials on psychosocial intervention programmes for pre-school children with autism spectrum disorder (ASD). To achieve better quality of unbiased evidence for the effectiveness of ASD interventions, it is necessary to conduct a comprehensive review that covers studies with adequate quality standards, such as randomised controlled trials (RCTs), and different types of intervention In this study, we categorize interventions for ASD as behavioural, social-communication focused, and multimodal developmental based on Howlin's classification of early interventions for children with ASD. The aim of this study was to compare these three models and investigate the strengths and weaknesses of each type of intervention and to identify the approaches that contribute to a successful outcome for children with autism. We performed a systematic review and meta-analysis. We included RCTs targeting children with ASD 6 years old or younger. A random effects model was used to present the effect estimate for the outcomes. This study also performed combined meta-analyses of all the three models to investigate the overall effectiveness of the intervention programmes. 32 randomized controlled studies were found to be eligible for inclusion. The synthesized data included 594 children from 14 RCTs. There was no statistically significant difference in the effects on autism general symptoms between the social-communication-focused model and the multimodal developmental model (p = 0.83). The results suggest that there is evidence of an effect on 'reciprocity of social interaction towards others' (standard mean difference [95% confidential interval] = 0.53[0.29,0.78], pASD have significant effects on a generalized skill to engage in reciprocal interactions with others. However, the outcomes of 'reciprocity of social interaction towards others' and 'parental synchrony' may be promising targets for interventions involving pre-school children with ASD

Can complex health interventions be evaluated using routine clinical and administrative data? - a realist evaluation approach.

Science.gov (United States)

Riippa, Iiris; Kahilakoski, Olli-Pekka; Linna, Miika; Hietala, Minni

2014-12-01

Interventions aimed at improving chronic care typically consist of multiple interconnected parts, all of which are essential to the effect of the intervention. Limited attention has been paid to the use of routine clinical and administrative data in the evolution of these complex interventions. The purpose of this study is to examine the feasibility of routinely collected data when evaluating complex interventions and to demonstrate how a theory-based, realist approach to evaluation may increase the feasibility of routine data. We present a case study of evaluating a complex intervention, namely, the chronic care model (CCM), in Finnish primary health care. Issues typically faced when evaluating the effects of a complex intervention on health outcomes and resource use are identified by using routine data in a natural setting, and we apply context-mechanism-outcome (CMO) approach from the realist evaluation paradigm to improve the feasibility of using routine data in evaluating complex interventions. From an experimentalist approach that dominates the medical literature, routine data collected from a single centre offered a poor starting point for evaluating complex interventions. However, the CMO approach offered tools for identifying indicators needed to evaluate complex interventions. Applying the CMO approach can aid in a typical evaluation setting encountered by primary care managers: one in which the intervention is complex, the primary data source is routinely collected clinical and administrative data from a single centre, and in which randomization of patients into two research arms is too resource consuming to arrange. © 2014 John Wiley & Sons, Ltd.

Interventions for replacing missing teeth: treatment of perimplantitis.

Science.gov (United States)

Esposito, Marco; Grusovin, Maria Gabriella; Tzanetea, Eleni; Piattelli, Adriano; Worthington, Helen V

2010-06-16

One of the key factors for the long-term success of oral implants is the maintenance of healthy tissues around them. Bacterial plaque accumulation induces inflammatory changes in the soft tissues surrounding oral implants and it may lead to their progressive destruction (perimplantitis) and ultimately to implant failure. Different treatment strategies for perimplantitis have been suggested, however it is unclear which are the most effective. To identify the most effective interventions for treating perimplantitis around osseointegrated dental implants. We searched the Cochrane Oral Health Group's Trials Register, CENTRAL, MEDLINE and EMBASE. Handsearching included several dental journals. We checked the bibliographies of the identified randomised controlled trials (RCTs) and relevant review articles for studies outside the handsearched journals. We wrote to authors of all identified RCTs, to more than 55 dental implant manufacturers and an Internet discussion group to find unpublished or ongoing RCTs. No language restrictions were applied. The last electronic search was conducted on 7th January 2010. All RCTs comparing agents or interventions for treating perimplantitis around dental implants. Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted in duplicate and independently by two review authors. We contacted the authors for missing information. Results were expressed as random-effects models using mean differences for continuous outcomes and risk ratios for dichotomous outcomes with 95% confidence intervals (CI). Heterogeneity was to be investigated including both clinical and methodological factors. Twelve eligible trials were identified, but five were excluded. The following procedures were tested: (1) use of local antibiotics versus ultrasonic debridement; (2) benefits of adjunctive local antibiotics to debridement; (3) different techniques of subgingival debridement; (4) laser versus manual

Impact evaluation of infrastructure interventions

DEFF Research Database (Denmark)

Hansen, Henrik; Andersen, Ole Winckler; White, Howard

2011-01-01

in this volume. Understanding impact means understanding the context in which an intervention takes place and the channels through which the impact on outcomes is expected to occur. Such analysis typically requires mixing both quantitative and qualitative approaches. The analysis will also anticipate......The focus on results in development agencies has led to increased focus on impact evaluation to demonstrate the effectiveness of development programmes. A range of methods are available for counterfactual analysis of infrastructure interventions, as illustrated by the variety of papers...

Digital Support Interventions for the Self-Management of Low Back Pain: A Systematic Review.

Science.gov (United States)

Nicholl, Barbara I; Sandal, Louise F; Stochkendahl, Mette J; McCallum, Marianne; Suresh, Nithya; Vasseljen, Ottar; Hartvigsen, Jan; Mork, Paul J; Kjaer, Per; Søgaard, Karen; Mair, Frances S

2017-05-21

Low back pain (LBP) is a common cause of disability and is ranked as the most burdensome health condition globally. Self-management, including components on increased knowledge, monitoring of symptoms, and physical activity, are consistently recommended in clinical guidelines as cost-effective strategies for LBP management and there is increasing interest in the potential role of digital health. The study aimed to synthesize and critically appraise published evidence concerning the use of interactive digital interventions to support self-management of LBP. The following specific questions were examined: (1) What are the key components of digital self-management interventions for LBP, including theoretical underpinnings? (2) What outcome measures have been used in randomized trials of digital self-management interventions in LBP and what effect, if any, did the intervention have on these? and (3) What specific characteristics or components, if any, of interventions appear to be associated with beneficial outcomes? Bibliographic databases searched from 2000 to March 2016 included Medline, Embase, CINAHL, PsycINFO, Cochrane Library, DoPHER and TRoPHI, Social Science Citation Index, and Science Citation Index. Reference and citation searching was also undertaken. Search strategy combined the following concepts: (1) back pain, (2) digital intervention, and (3) self-management. Only randomized controlled trial (RCT) protocols or completed RCTs involving adults with LBP published in peer-reviewed journals were included. Two reviewers independently screened titles and abstracts, full-text articles, extracted data, and assessed risk of bias using Cochrane risk of bias tool. An independent third reviewer adjudicated on disagreements. Data were synthesized narratively. Of the total 7014 references identified, 11 were included, describing 9 studies: 6 completed RCTs and 3 protocols for future RCTs. The completed RCTs included a total of 2706 participants (range of 114

Patient-mediated knowledge translation (PKT) interventions for clinical encounters: a systematic review.

Science.gov (United States)

Gagliardi, Anna R; Légaré, France; Brouwers, Melissa C; Webster, Fiona; Badley, Elizabeth; Straus, Sharon

2016-02-29

Patient-mediated knowledge translation (PKT) interventions engage patients in their own health care. Insight on which PKT interventions are effective is lacking. We sought to describe the type and impact of PKT interventions. We performed a systematic review of PKT interventions, defined as strategies that inform, educate and engage patients in their own health care. We searched MEDLINE, EMBASE and the Cochrane Library from 2005 to 2014 for English language studies that evaluated PKT interventions delivered immediately before, during or upon conclusion of clinical encounters to individual patients with arthritis or cancer. Data were extracted on study characteristics, PKT intervention (theory, content, delivery, duration, personnel, timing) and outcomes. Interventions were characterized by type of patient engagement (inform, activate, collaborate). We performed content analysis and reported summary statistics. Of 694 retrieved studies, 16 were deemed eligible (5 arthritis, 11 cancer; 12 RCTs, 4 cohort studies; 7 low, 3 uncertain, 6 high risk of bias). PKT interventions included print material in 10 studies (brochures, booklets, variety of print material, list of websites), electronic material in 10 studies (video, computer program, website) and counselling in 2 studies. They were offered before, during and after consultation in 4, 1 and 4 studies, respectively; as single or multifaceted interventions in 10 and 6 studies, respectively; and by clinicians, health educators, researchers or volunteers in 4, 3, 5 and 1 study, respectively. Most interventions informed or activated patients. All studies achieved positive impact in one or more measures of patient knowledge, decision-making, communication and behaviour. This was true regardless of condition, PKT intervention, timing, personnel, type of engagement or delivery (single or multifaceted). No studies assessed patient harms, or interventions for providers to support PKT intervention delivery. Two studies evaluated

Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years.

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Colquitt, Jill L; Loveman, Emma; O'Malley, Claire; Azevedo, Liane B; Mead, Emma; Al-Khudairy, Lena; Ells, Louisa J; Metzendorf, Maria-Inti; Rees, Karen

2016-03-10

Child overweight and obesity has increased globally, and can be associated with short- and long-term health consequences. To assess the effects of diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years. We performed a systematic literature search in the databases Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, and LILACS, as well as in the trial registers ClinicalTrials.gov and ICTRP Search Portal. We also checked references of identified trials and systematic reviews. We applied no language restrictions. The date of the last search was March 2015 for all databases. We selected randomised controlled trials (RCTs) of diet, physical activity, and behavioural interventions for treating overweight or obesity in preschool children aged 0 to 6 years. Two review authors independently assessed risk of bias, evaluated the overall quality of the evidence using the GRADE instrument, and extracted data following the Cochrane Handbook for Systematic Reviews of Interventions. We contacted trial authors for additional information. We included 7 RCTs with a total of 923 participants: 529 randomised to an intervention and 394 to a comparator. The number of participants per trial ranged from 18 to 475. Six trials were parallel RCTs, and one was a cluster RCT. Two trials were three-arm trials, each comparing two interventions with a control group. The interventions and comparators in the trials varied. We categorised the comparisons into two groups: multicomponent interventions and dietary interventions. The overall quality of the evidence was low or very low, and six trials had a high risk of bias on individual 'Risk of bias' criteria. The children in the included trials were followed up for between six months and three years.In trials comparing a multicomponent intervention with usual care, enhanced usual care, or information control, we found a greater reduction in body mass index (BMI

A framework for the evaluation of new interventional procedures.

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Lourenco, Tania; Grant, Adrian M; Burr, Jennifer M; Vale, Luke

2012-03-01

The introduction of new interventional procedures is less regulated than for other health technologies such as pharmaceuticals. Decisions are often taken on evidence of efficacy and short-term safety from small-scale usually observational studies. This reflects the particular challenges of evaluating interventional procedures - the extra facets of skill and training and the difficulty defining a 'new' technology. Currently, there is no framework to evaluate new interventional procedures before they become available in clinical practice as opposed to new pharmaceuticals. This paper proposes a framework to guide the evaluation of a new interventional procedure. A framework was developed consisting of a four-stage progressive evaluation for a new interventional procedure: Stage 1: Development; Stage 2: Efficacy and short-term safety; Stage 3: Effectiveness and cost-effectiveness; and Stage 4: Implementation. The framework also suggests the types of studies or data collection methods that can be used to satisfy each stage. This paper makes a first step on a framework for generating evidence on new interventional procedures. The difficulties and limitations of applying such a framework are discussed. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

DEFF Research Database (Denmark)

Savović, J; Jones, He; Altman, Dg

2012-01-01

The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

Interventions to address unequal gender and power relations and improve self-efficacy and empowerment for sexual and reproductive health decision-making for women living with HIV: A systematic review.

Directory of Open Access Journals (Sweden)

Jennifer L Robinson

Full Text Available Many women living with HIV experience gendered power inequalities, particularly in their intimate relationships, that prevent them from achieving optimal sexual and reproductive health (SRH and exercising their rights. We assessed the effectiveness of interventions to improve self-efficacy and empowerment of women living with HIV to make SRH decisions through a systematic review.We included peer-reviewed articles indexed in PubMed, PsycINFO, CINAHL, Embase, and Scopus published through January 3, 2017, presenting multi-arm or pre-post intervention evaluations measuring one of the following outcomes: (1 self-efficacy, empowerment, or measures of SRH decision-making ability, (2 SRH behaviors (e.g., condom use, contraceptive use, or (3 SRH outcomes (e.g., sexually transmitted infections [STIs]. Twenty-one studies evaluating 11 intervention approaches met the inclusion criteria. All were conducted in the United States or sub-Saharan Africa. Two high-quality randomized controlled trials (RCTs showed significant decreases in incident gonorrhea and chlamydia. Sixteen studies measuring condom use generally found moderate increases associated with the intervention, including in higher-quality RCTs. Findings on contraceptive use, condom self-efficacy, and other empowerment measures (e.g., sexual communication, equitable relationship power were mixed. Studies were limited by small sample sizes, high loss to follow-up, and high reported baseline condom use.While more research is needed, the limited existing evidence suggests that these interventions may help support the SRH and rights of women living with HIV. This review particularly highlights the importance of these interventions for preventing STIs, which present a significant health burden for women living with HIV that is rarely addressed holistically. Empowerment-based interventions should be considered as part of a comprehensive package of STI and other SRH services for women living with HIV.

Evaluation of complex community-based childhood obesity prevention interventions.

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Karacabeyli, D; Allender, S; Pinkney, S; Amed, S

2018-05-16

Multi-setting, multi-component community-based interventions have shown promise in preventing childhood obesity; however, evaluation of these complex interventions remains a challenge. The objective of the study is to systematically review published methodological approaches to outcome evaluation for multi-setting community-based childhood obesity prevention interventions and synthesize a set of pragmatic recommendations. MEDLINE, CINAHL and PsycINFO were searched from inception to 6 July 2017. Papers were included if the intervention targeted children ≤18 years, engaged at least two community sectors and described their outcome evaluation methodology. A single reviewer conducted title and abstract scans, full article review and data abstraction. Directed content analysis was performed by three reviewers to identify prevailing themes. Thirty-three studies were included, and of these, 26 employed a quasi-experimental design; the remaining were randomized control trials. Body mass index was the most commonly measured outcome, followed by health behaviour change and psychosocial outcomes. Six themes emerged, highlighting advantages and disadvantages of active vs. passive consent, quasi-experimental vs. randomized control trials, longitudinal vs. repeat cross-sectional designs and the roles of process evaluation and methodological flexibility in evaluating complex interventions. Selection of study designs and outcome measures compatible with community infrastructure, accompanied by process evaluation, may facilitate successful outcome evaluation. © 2018 World Obesity Federation.

Telephone delivered interventions for reducing morbidity and mortality in people with HIV infection.

Science.gov (United States)

Gentry, Sarah; van-Velthoven, Michelle H M M T; Tudor Car, Lorainne; Car, Josip

2013-05-31

This is one of three Cochrane reviews examining the role of the telephone in HIV/AIDS services. Telephone interventions, delivered either by landline or mobile phone, may be useful in the management of people living with HIV (PLHIV) in many situations. Telephone delivered interventions have the potential to reduce costs, save time and facilitate more support for PLHIV. To assess the effectiveness of voice landline and mobile telephone delivered interventions for reducing morbidity and mortality in people with HIV infection. We searched The Cochrane Central Register of Controlled Trials, MEDLINE, PubMed Central, EMBASE, PsycINFO, ISI Web of Science, Cumulative Index to Nursing & Allied Health, World Health Organisation's The Global Health Library and Current Controlled Trials from 1980 to June 2011. We searched the following grey literature sources: Dissertation Abstracts International, Centre for Agriculture Bioscience International Direct Global Health database, The System for Information on Grey Literature Europe, The Healthcare Management Information Consortium database, Google Scholar, Conference on Retroviruses and Opportunistic Infections, International AIDS Society, AIDS Educational Global Information System and reference lists of articles. Randomised controlled trials (RCTs), quasi-randomised controlled trials, controlled before and after studies, and interrupted time series studies comparing the effectiveness of telephone delivered interventions for reducing morbidity and mortality in persons with HIV infection versus in-person interventions or usual care, regardless of demographic characteristics and in all settings. Both mobile and landline telephone interventions were included, but mobile phone messaging interventions were excluded. Two reviewers independently searched, screened, assessed study quality and extracted data. Primary outcomes were change in behaviour, healthcare uptake or clinical outcomes. Secondary outcomes were appropriateness of the

Pharmacological interventions for the prevention of insufficiency fractures and avascular necrosis associated with pelvic radiotherapy in adults.

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van den Blink, Qurrat U; Garcez, Kate; Henson, Caroline C; Davidson, Susan E; Higham, Claire E

2018-04-23

obtain missing data. Data were to be pooled using the random-effects model if study comparisons were similar, otherwise results were to be reported narratively. We included two RCTs (1167 participants). The first RCT compared zoledronic acid with placebo in 96 men undergoing pelvic radiotherapy for non-metastatic prostate cancer.The second RCT had four treatment arms, two of which evaluated zoledronic acid plus adjuvant androgen suppression compared with androgen suppression only in 1071 men undergoing pelvic radiotherapy for non-metastatic prostate cancer.Both studies were at a moderate to high risk of bias and all evidence was judged to be of very low certainty.The studies provided no evidence on the primary outcomes of the review and provided limited data in relation to secondary outcomes, such that meta-analyses were not possible. Both studies focused on interventions to improve bone health in relation to androgen deprivation rather than radiation-related insufficiency fractures and avascular necrosis. Few fractures were described in each study and those described were not specific to insufficiency fractures secondary to radiotherapy. Both studies reported that zoledronic acid in addition to androgen deprivation and pelvic radiotherapy led to improvements in BMD; however, the changes in BMD were measured and reported differently. There was no available evidence regarding adverse effects. The evidence relating to interventions to prevent insufficiency fractures and avascular necrosis associated with pelvic radiotherapy in adults is of very low certainty. This review highlights the need for prospective clinical trials using interventions prior to and during radiotherapy to prevent radiation-related bone morbidity, insufficiency fractures and avascular necrosis. Future trials could involve prospective assessment of bone health including BMD and bone turnover markers prior to pelvic radiotherapy. The interventions for investigation could begin as radiotherapy commences

Is reflexology an effective intervention? A systematic review of randomised controlled trials.

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Ernst, Edzard

2009-09-07

To evaluate the evidence for and against the effectiveness of reflexology for treating any medical condition. Six electronic databases were searched from their inception to February 2009 to identify all relevant randomised controlled trials (RCTs). No language restrictions were applied. RCTs of reflexology delivered by trained reflexologists to patients with specific medical conditions. Condition studied, study design and controls, primary outcome measures, follow-up, and main results were extracted. 18 RCTs met all the inclusion criteria. The studies examined a range of conditions: anovulation, asthma, back pain, dementia, diabetes, cancer, foot oedema in pregnancy, headache, irritable bowel syndrome, menopause, multiple sclerosis, the postoperative state and premenstrual syndrome. There were > 1 studies for asthma, the postoperative state, cancer palliation and multiple sclerosis. Five RCTs yielded positive results. Methodological quality was evaluated using the Jadad scale. The methodological quality was often poor, and sample sizes were generally low. Most higher-quality trials did not generate positive findings. The best evidence available to date does not demonstrate convincingly that reflexology is an effective treatment for any medical condition.

A Systematic Review on the Effectiveness of Interventions to Improve Hand Hygiene Compliance of Nurses in the Hospital Setting.

Science.gov (United States)

Rn, Olena Doronina; Jones, Denise; Martello, Marianna; Biron, Alain; Lavoie-Tremblay, Mélanie

2017-03-01

The purpose of the present systematic review is to identify the interventions that improve hand hygiene compliance (HHC) specifically among nurses. A systematic review was performed guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses to evaluate the short and long-term effects of interventions to promote hand hygiene practices among nurses in the hospital setting. A search of the Cumulative Index to Nursing and Allied Health Literature, Medline Global Health, and Embase was conducted in addition to studies identified by the most recent systematic review. Six studies met inclusion criteria: three randomized controlled trials (RCTs), one controlled before and after studies (CBAs), and two interrupted times series (ITS). One RCT reported effectiveness and 6-month sustainability of the effect related to multimodal-directed and multimodal with team leadership-directed strategies. The other two RCTs found positive effect of education and feedback on compliance; however, compliance rates declined after 1 month. Education was also found to improve HHC up to 3 months postintervention. An electronic reminder and feedback system evaluated by an ITS improved HHC and detected variation in HHC through the day. This review showed that single and combined interventions do improve hand hygiene practices among nurses; however, there is a need for more methodologically robust studies to define the most effective and sustainable interventions. Although hand hygiene is the most effective measure to prevent healthcare-associated infections, compliance with hand hygiene remains low. Nurses are among the healthcare providers who spend the most time in direct patient contact. Therefore, there is a need for research to identify the interventions that improve HHC in this group. © 2017 Sigma Theta Tau International.

[Evaluation of patient doses in interventional radiology].

Science.gov (United States)

Ropolo, R; Rampado, O; Isoardi, P; Gandini, G; Rabbia, C; Righi, D

2001-01-01

To verify the suitability of indicative quantities to evaluate the risk related to patient exposure, in abdominal and vascular interventional radiology, by the study of correlations between dosimetric quantities and other indicators. We performed in vivo measurements of entrance skin dose (ESD) and dose area product (DAP) during 48 procedures to evaluate the correlation among dosimetric quantities, and an estimation of spatial distribution of exposure and effective dose (E). To measure DAP we used a transmission ionization chamber and to evaluate ESD and its spatial distribution we used radiographic film packed in a single envelope and placed near the patient's skin. E was estimated by a calculation software using data from film digitalisation. From the data derived for measurements in 27 interventional procedures on 48 patients we obtained a DAP to E conversion factor of 0.15 mSv / Gy cm2, with an excellent correlation (r=.99). We also found a good correlation between DAP and exposure parameters such as fluoroscopy time and number of images. The greatest effective dose was evaluated for a multiple procedure in the hepatic region, with a DAP value of 425 Gy cm2. The greatest ESD was about 550 mGy. For groups of patients undergoing similar interventional procedures the correlation between ESD and DAP had conversion factors from 6 to 12 mGy Gy-1 cm-2. The evaluation of ESD and E by slow films represents a valid method for patient dosimetry in interventional radiology. The good correlation between DAP and fluoroscopy time and number of images confirm the suitability of these indicators as basic dosimetric information. All the ESD values found are lower than threshold doses for deterministic effects.

Effects of web-based interventions on cancer patients' symptoms: review of randomized trials.

Science.gov (United States)

Fridriksdottir, N; Gunnarsdottir, S; Zoëga, S; Ingadottir, B; Hafsteinsdottir, E J G

2018-02-01

Symptom management is of high priority in cancer care. Information and communication technology allows interventions to be provided through the internet to enhance the delivery of care. This study aimed to review the effects of web-based interventions on cancer patients' symptoms. MEDLINE, PSychINFO, PubMed, CINAHL, and Cochrane databases were systematically searched. Included were randomized controlled trials (RCTs), pilot RCTs, or quasi-experimental (QE) studies focusing on web-based interventions in adult cancer patients with at least one outcome primary or secondary, in terms of symptoms, treatment side effects, or distress. Data were analyzed study by study. Twenty studies were identified. All web interventions included information, 16 included self-management support, 14 included self-monitoring, 13 included feedback/tailored information, 12 used communication with health-care professionals, and eight used communication with other patients. Overall, 13 studies reported positive symptom outcomes. Psychological distress was reported in eight studies with positive intervention effects in three. Symptoms of anxiety/depression were reported in ten studies with positive intervention effects in five. Somatic symptom severity was reported in ten studies with intervention effects found in six, and symptom distress was reported in six studies with intervention effects found in all. This review shows the promising potential of web-based interventions for cancer symptom management, although it was limited by considerable heterogeneity in the interventions tested and targeted outcomes. The multidimensional nature of symptoms was partly addressed; only one study was guided by a comprehensive theoretical model of cancer symptom management. It can only be speculated which web elements are important for effective symptom outcomes. Further testing is needed for web-based cancer symptom management.

Clinical Impact Research - how to choose experimental or observational intervention study?

Science.gov (United States)

Malmivaara, Antti

2016-11-01

Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental

Interventions for emergency contraception.

Science.gov (United States)

Shen, Jie; Che, Yan; Showell, Emily; Chen, Ke; Cheng, Linan

2017-08-02

Emergency contraception (EC) is using a drug or copper intrauterine device (Cu-IUD) to prevent pregnancy shortly after unprotected intercourse. Several interventions are available for EC. Information on the comparative effectiveness, safety and convenience of these methods is crucial for reproductive healthcare providers and the women they serve. This is an update of a review previously published in 2009 and 2012. To determine which EC method following unprotected intercourse is the most effective, safe and convenient to prevent pregnancy. In February 2017 we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Popline and PubMed, The Chinese biomedical databases and UNDP/UNFPA/WHO/World Bank Special Programme on Human Reproduction (HRP) emergency contraception database. We also searched ICTRP and ClinicalTrials.gov as well as contacting content experts and pharmaceutical companies, and searching reference lists of appropriate papers. Randomised controlled trials including women attending services for EC following a single act of unprotected intercourse were eligible. We used standard methodological procedures recommended by Cochrane. The primary review outcome was observed number of pregnancies. Side effects and changes of menses were secondary outcomes. We included 115 trials with 60,479 women in this review. The quality of the evidence for the primary outcome ranged from moderate to high, and for other outcomes ranged from very low to high. The main limitations were risk of bias (associated with poor reporting of methods), imprecision and inconsistency. Comparative effectiveness of different emergency contraceptive pills (ECP)Levonorgestrel was associated with fewer pregnancies than Yuzpe (estradiol-levonorgestrel combination) (RR 0.57, 95% CI 0.39 to 0.84, 6 RCTs, n = 4750, I 2 = 23%, high-quality evidence). This suggests that if the chance of pregnancy using Yuzpe is assumed to be 29 women per 1000, the chance of pregnancy using levonorgestrel would be between

Interventions to improve water quality for preventing diarrhoea.

Science.gov (United States)

Clasen, Thomas F; Alexander, Kelly T; Sinclair, David; Boisson, Sophie; Peletz, Rachel; Chang, Howard H; Majorin, Fiona; Cairncross, Sandy

2015-10-20

Diarrhoea is a major cause of death and disease, especially among young children in low-income countries. In these settings, many infectious agents associated with diarrhoea are spread through water contaminated with faeces.In remote and low-income settings, source-based water quality improvement includes providing protected groundwater (springs, wells, and bore holes), or harvested rainwater as an alternative to surface sources (rivers and lakes). Point-of-use water quality improvement interventions include boiling, chlorination, flocculation, filtration, or solar disinfection, mainly conducted at home. To assess the effectiveness of interventions to improve water quality for preventing diarrhoea. We searched the Cochrane Infectious Diseases Group Specialized Register (11 November 2014), CENTRAL (the Cochrane Library, 7 November 2014), MEDLINE (1966 to 10 November 2014), EMBASE (1974 to 10 November 2014), and LILACS (1982 to 7 November 2014). We also handsearched relevant conference proceedings, contacted researchers and organizations working in the field, and checked references from identified studies through 11 November 2014. Randomized controlled trials (RCTs), quasi-RCTs, and controlled before-and-after studies (CBA) comparing interventions aimed at improving the microbiological quality of drinking water with no intervention in children and adults. Two review authors independently assessed trial quality and extracted data. We used meta-analyses to estimate pooled measures of effect, where appropriate, and investigated potential sources of heterogeneity using subgroup analyses. We assessed the quality of evidence using the GRADE approach. Forty-five cluster-RCTs, two quasi-RCTs, and eight CBA studies, including over 84,000 participants, met the inclusion criteria. Most included studies were conducted in low- or middle-income countries (LMICs) (50 studies) with unimproved water sources (30 studies) and unimproved or unclear sanitation (34 studies). The primary

Survey Email Scheduling and Monitoring in eRCTs (SESAMe): A Digital Tool to Improve Data Collection in Randomized Controlled Clinical Trials.

Science.gov (United States)

Skonnord, Trygve; Steen, Finn; Skjeie, Holgeir; Fetveit, Arne; Brekke, Mette; Klovning, Atle

2016-11-22

Electronic questionnaires can ease data collection in randomized controlled trials (RCTs) in clinical practice. We found no existing software that could automate the sending of emails to participants enrolled into an RCT at different study participant inclusion time points. Our aim was to develop suitable software to facilitate data collection in an ongoing multicenter RCT of low back pain (the Acuback study). For the Acuback study, we determined that we would need to send a total of 5130 emails to 270 patients recruited at different centers and at 19 different time points. The first version of the software was tested in a pilot study in November 2013 but was unable to deliver multiuser or Web-based access. We resolved these shortcomings in the next version, which we tested on the Web in February 2014. Our new version was able to schedule and send the required emails in the full-scale Acuback trial that started in March 2014. The system architecture evolved through an iterative, inductive process between the project study leader and the software programmer. The program was tested and updated when errors occurred. To evaluate the development of the software, we used a logbook, a research assistant dialogue, and Acuback trial participant queries. We have developed a Web-based app, Survey Email Scheduling and Monitoring in eRCTs (SESAMe), that monitors responses in electronic surveys and sends reminders by emails or text messages (short message service, SMS) to participants. The overall response rate for the 19 surveys in the Acuback study increased from 76.4% (655/857) before we introduced reminders to 93.11% (1149/1234) after the new function (P<.001). Further development will aim at securing encryption and data storage. The SESAMe software facilitates consecutive patient data collection in RCTs and can be used to increase response rates and quality of research, both in general practice and in other clinical trial settings. ©Trygve Skonnord, Finn Steen, Holgeir

Do brief alcohol motivational interventions work like we think they do?

Science.gov (United States)

Bertholet, Nicolas; Palfai, Tibor; Gaume, Jacques; Daeppen, Jean-Bernard; Saitz, Richard

2014-03-01

Questions remain about how brief motivational interventions (BMIs) for unhealthy alcohol use work, and addressing these questions may be important for improving their efficacy. Therefore, we assessed the effects of various characteristics of BMIs on drinking outcomes across 3 randomized controlled trials (RCTs). Audio recordings of 314 BMIs were coded. We used the global rating scales of the Motivational Interviewing Skills Code (MISC) 2.1: counselor's acceptance, empathy, and motivational interviewing (MI) spirit, and patient's self-exploration were rated. MI proficiency was defined as counselor's rating scale scores ≥5. We also used the structure, confrontation, and advice subscale scores of the Therapy Process Rating Scale and the Working Alliance Inventory. We examined these process characteristics in interventions across 1 U.S. RCT of middle-aged medical inpatients with unhealthy alcohol use (n = 124) and 2 Swiss RCTs of young men with binge drinking in a nonclinical setting: Swiss-one (n = 62) and Swiss-two (n = 128). We assessed the associations between these characteristics and drinks/d reported by participants 3 to 6 months after study entry. In all 3 RCTs, mean MISC counselor's rating scales scores were consistent with MI proficiency. In overdispersed Poisson regression models, most BMI characteristics were not significantly associated with drinks/d in follow-up. In the U.S. RCT, confrontation and self-exploration were associated with more drinking. Giving advice was significantly associated with less drinking in the Swiss-one RCT. Contrary to expectations, MI spirit was not consistently associated with drinking across studies. Across different populations and settings, intervention characteristics viewed as central to efficacious BMIs were neither robust nor consistent predictors of drinking outcome. Although there may be alternative reasons why the level of MI processes was not predictive of outcomes in these studies (limited variability in

eHealth Technologies as an Intervention to Improve Adherence to Topical Antipsoriatics

DEFF Research Database (Denmark)

Svendsen, Mathias Tiedemann; Andersen, Flemming; Andersen, Klaus Ejner

2018-01-01

BACKGROUND: Topical antipsoriatics are recommended first-line treatment of psoriasis, but rates of adherence are low. Patient support by use of electronic health (eHealth) services is suggested to improve medical adherence. OBJECTIVE: To review randomised controlled trials (RCTs) testing eHealth...... interventions designed to improve adherence to topical antipsoriatics and to review applications for smartphones (apps) incorporating the word psoriasis. MATERIAL AND METHODS: Literature review: Medline, Embase, Cochrane, PsycINFO, and Web of Science were searched using search terms for eHealth, psoriasis....... CONCLUSION: There is a critical need for high-quality RCTs testing if the ubiquitous eHealth technologies, e.g. some of the numerous apps, can improve psoriasis patients' rates of adherence to topical antipsoriatics....

Antenatal interventions to reduce preterm birth: an overview of Cochrane Systematic Reviews.

Science.gov (United States)

Piso, Brigitte; Zechmeister-Koss, Ingrid; Winkler, Roman

2014-04-23

Several factors are associated with an increased risk of preterm birth (PTB); therefore, various interventions might have the potential to influence it. Due to the large number of interventions that address PTB, the objective of this overview is to summarise evidence from Cochrane reviews regarding the effects and safety of these different interventions. We conducted a systematic literature search in the Cochrane Database of Systematic Reviews. Included reviews should be based on randomised controlled trials comparing antenatal non-pharmacological and pharmacological interventions that directly or indirectly address PTB with placebo/no treatment or routine care in pregnant women at less than 37 completed weeks of gestation without signs of threatened preterm labour. We considered PTB at less than 37 completed weeks of gestation as the primary outcome. We included 56 Cochrane systematic reviews. Three interventions increased PTB risk significantly. Twelve interventions led to a statistically significant lower incidence of PTBs. However, this reduction was mostly observed in defined at-risk subgroups of pregnant women. The remaining antenatal interventions failed to prove a significant effect on PTB PTBs). As an unintended result of this review, we identified 28 additional Cochrane reviews which intended to report on PTB < 37 weeks, but were not able to find any RCTs reporting appropriate data. The possible effects of a diverse range of interventions on PTB have been evaluated in Cochrane systematic reviews. Few interventions have been demonstrated to be effective and a small number have been found to be harmful. For around half of the interventions evaluated, the Cochrane review concluded that there was insufficient evidence to provide sound recommendations for clinical practice. No RCT evidence is available for a number of potentially relevant interventions.

Mind-body interventions for fear of cancer recurrence: A systematic review and meta-analysis.

Science.gov (United States)

Hall, Daniel L; Luberto, Christina M; Philpotts, Lisa L; Song, Rhayun; Park, Elyse R; Yeh, Gloria Y

2018-05-10

Fear of cancer recurrence (FCR) is a common existential concern and source of distress among adults with a cancer history. Multiple randomized controlled trials (RCTs) have examined mind-body approaches to mitigating FCR. We summarized characteristics of these trials and calculated their pooled effects on decreasing FCR. Six electronic databases were systematically searched from inception to May 2017, using a strategy that included multiple terms for RCTs, cancer, mind-body medicine, and FCR. Data extraction and reporting followed Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Pooled effect sizes on self-report measures of FCR were computed by using random-effects models. Nineteen RCTs (pooled N = 2806) were included. Most studies (53%) were published since 2015 and targeted a single cancer type (84%; mostly breast). Intervention sessions (median = 6, mode = 4) tended to last 120 minutes and occur across 1.5 months. Delivery was predominantly in-person (63%) to either groups (42%) or individuals (42%). Most interventions incorporated multiple mind-body components (53%), commonly cognitive-behavioral skills (58%), or meditative practices (53%). Small-to-medium pooled effect sizes were observed postintervention (Hedges' g = -0.36, 95% CI = -0.49, -0.23, P control group design, group/individual delivery, use of cognitive-behavioral or mindfulness skills, number of mind-body components, cancer treatment status, and number of sessions) did not reach statistical significance. Mind-body interventions are efficacious for reducing FCR, with small-to-medium effect sizes that persist after intervention delivery ends. Recommendations include testing effects among survivors of various cancers and exploring the optimal integration of mind-body practices for managing fundamental uncertainties and fears during cancer survivorship. Copyright © 2018 John Wiley & Sons, Ltd.

Improving subjective perception of personal cancer risk: systematic review and meta-analysis of educational interventions for people with cancer or at high risk of cancer.

Science.gov (United States)

Dieng, Mbathio; Watts, Caroline G; Kasparian, Nadine A; Morton, Rachael L; Mann, Graham J; Cust, Anne E

2014-06-01

Newly diagnosed patients with cancer require education about the disease, the available treatments and potential consequences of treatment. Greater understanding of cancer risk has been found to be associated with greater health-related quality of life, improved psychological adjustment and greater health-related behaviours. The aim of this sytematic review was to assess the effectiveness of educational interventions in improving subjective cancer risk perception and to appraise the quality of the studies. We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) and prospective observational studies. Eligible studies were identified via Medline, PsycINFO, AMED, CINAHL and Embase databases. After screening titles and abstracts, two reviewers independently assessed the eligibility of 206 full-text articles. Forty papers were included in the review; the majority of studies were conducted among breast cancer patients (n = 29) and evaluated the effect of genetic counselling on personal perceived risk (n = 25). Pooled results from RCTs (n = 12) showed that, both in the short and long term, educational interventions did not significantly influence risk perception level (standardised mean difference 0.05, 95% CI -0.24-0.34; p = 0.74) or accuracy (odds ratio = 1.96, 95% CI: 0.61-6.25; p = 0.26). Only one RCT reported a short-term difference in risk ratings (p = 0.01). Of prospective observational studies (n = 28), many did demonstrate changes in the level of perceived risk and improved risk accuracy and risk ratings in both the short and long term. However, only one (of three) observational studies reported a short-term difference in risk ratings (p < = 0.003). Further development and investigation of educational interventions using good quality, RCTs are warranted. Copyright © 2014 John Wiley & Sons, Ltd.

How Does Physical Activity Intervention Improve Self-Esteem and Self-Concept in Children and Adolescents? Evidence from a Meta-Analysis

Science.gov (United States)

Liu, Mingli; Wu, Lang; Ming, Qingsen

2015-01-01

Objective To perform a systematic review and meta-analysis for the effects of physical activity intervention on self-esteem and self-concept in children and adolescents, and to identify moderator variables by meta-regression. Design A meta-analysis and meta-regression. Method Relevant studies were identified through a comprehensive search of electronic databases. Study inclusion criteria were: (1) intervention should be supervised physical activity, (2) reported sufficient data to estimate pooled effect sizes of physical activity intervention on self-esteem or self-concept, (3) participants’ ages ranged from 3 to 20 years, and (4) a control or comparison group was included. For each study, study design, intervention design and participant characteristics were extracted. R software (version 3.1.3) and Stata (version 12.0) were used to synthesize effect sizes and perform moderation analyses for determining moderators. Results Twenty-five randomized controlled trial (RCT) studies and 13 non-randomized controlled trial (non-RCT) studies including a total of 2991 cases were identified. Significant positive effects were found in RCTs for intervention of physical activity alone on general self outcomes (Hedges’ g = 0.29, 95% confidence interval [CI]: 0.14 to 0.45; p = 0.001), self-concept (Hedges’ g = 0.49, 95%CI: 0.10 to 0.88, p = 0.014) and self-worth (Hedges’ g = 0.31, 95%CI: 0.13 to 0.49, p = 0.005). There was no significant effect of intervention of physical activity alone on any outcomes in non-RCTs, as well as in studies with intervention of physical activity combined with other strategies. Meta-regression analysis revealed that higher treatment effects were associated with setting of intervention in RCTs (β = 0.31, 95%CI: 0.07 to 0.55, p = 0.013). Conclusion Intervention of physical activity alone is associated with increased self-concept and self-worth in children and adolescents. And there is a stronger association with school-based and gymnasium

How Does Physical Activity Intervention Improve Self-Esteem and Self-Concept in Children and Adolescents? Evidence from a Meta-Analysis.

Science.gov (United States)

Liu, Mingli; Wu, Lang; Ming, Qingsen

2015-01-01

To perform a systematic review and meta-analysis for the effects of physical activity intervention on self-esteem and self-concept in children and adolescents, and to identify moderator variables by meta-regression. A meta-analysis and meta-regression. Relevant studies were identified through a comprehensive search of electronic databases. Study inclusion criteria were: (1) intervention should be supervised physical activity, (2) reported sufficient data to estimate pooled effect sizes of physical activity intervention on self-esteem or self-concept, (3) participants' ages ranged from 3 to 20 years, and (4) a control or comparison group was included. For each study, study design, intervention design and participant characteristics were extracted. R software (version 3.1.3) and Stata (version 12.0) were used to synthesize effect sizes and perform moderation analyses for determining moderators. Twenty-five randomized controlled trial (RCT) studies and 13 non-randomized controlled trial (non-RCT) studies including a total of 2991 cases were identified. Significant positive effects were found in RCTs for intervention of physical activity alone on general self outcomes (Hedges' g = 0.29, 95% confidence interval [CI]: 0.14 to 0.45; p = 0.001), self-concept (Hedges' g = 0.49, 95%CI: 0.10 to 0.88, p = 0.014) and self-worth (Hedges' g = 0.31, 95%CI: 0.13 to 0.49, p = 0.005). There was no significant effect of intervention of physical activity alone on any outcomes in non-RCTs, as well as in studies with intervention of physical activity combined with other strategies. Meta-regression analysis revealed that higher treatment effects were associated with setting of intervention in RCTs (β = 0.31, 95%CI: 0.07 to 0.55, p = 0.013). Intervention of physical activity alone is associated with increased self-concept and self-worth in children and adolescents. And there is a stronger association with school-based and gymnasium-based intervention compared with other settings.

Mapping the evidence of prevention and intervention studies for suicidal and self-harming behaviors in young people.

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De Silva, Stefanie; Parker, Alexandra; Purcell, Rosemary; Callahan, Patrick; Liu, Ping; Hetrick, Sarah

2013-01-01

Suicide and self-harm (SSH) in young people is a major cause of disability-adjusted life years. Effective interventions are of critical importance to reducing the mortality and morbidity associated with SSH. To investigate the extent and nature of research on interventions to prevent and treat SSH in young people using evidence mapping. A systematic search for SSH intervention studies was conducted (participant mean age between 6-25 years). The studies were restricted to high-quality evidence in the form of systematic reviews, meta-analyses, and controlled trials. Thirty-eight controlled studies and six systematic reviews met the study inclusion criteria. The majority (n = 32) involved psychological interventions. Few studies (n = 9) involved treating young people with recognized mental disorders or substance abuse (n = 1) which also addressed SSH. The map was restricted to RCTs, CCTs, systematic reviews, and meta-analyses, and thus might have neglected important information from other study designs. The effectiveness of interventions within the trials was not evaluated. The evidence base for SSH interventions in young people is not well established, which hampers best-practice efforts in this area. Promising interventions that need further research include school-based prevention programs with a skills training component, individual CBT interventions, interpersonal psychotherapy, and attachment-based family therapy. Gaps in the research exist in evaluations of interventions for SSH in young people with identifiable psychopathology, particularly substance use disorder, and research that classifies participants on the basis of their suicidal intent.

Ethnographic methods for process evaluations of complex health behaviour interventions.

Science.gov (United States)

Morgan-Trimmer, Sarah; Wood, Fiona

2016-05-04

This article outlines the contribution that ethnography could make to process evaluations for trials of complex health-behaviour interventions. Process evaluations are increasingly used to examine how health-behaviour interventions operate to produce outcomes and often employ qualitative methods to do this. Ethnography shares commonalities with the qualitative methods currently used in health-behaviour evaluations but has a distinctive approach over and above these methods. It is an overlooked methodology in trials of complex health-behaviour interventions that has much to contribute to the understanding of how interventions work. These benefits are discussed here with respect to three strengths of ethnographic methodology: (1) producing valid data, (2) understanding data within social contexts, and (3) building theory productively. The limitations of ethnography within the context of process evaluations are also discussed.

Surgical interventions for gastric cancer: a review of systematic reviews.

Science.gov (United States)

He, Weiling; Tu, Jian; Huo, Zijun; Li, Yuhuang; Peng, Jintao; Qiu, Zhenwen; Luo, Dandong; Ke, Zunfu; Chen, Xinlin

2015-01-01

To evaluate methodological quality and the extent of concordance among meta-analysis and/or systematic reviews on surgical interventions for gastric cancer (GC). A comprehensive search of PubMed, Medline, EMBASE, the Cochrane library and the DARE database was conducted to identify the reviews comparing different surgical interventions for GC prior to April 2014. After applying included criteria, available data were summarized and appraised by the Oxman and Guyatt scale. Fifty six reviews were included. Forty five reviews (80.4%) were well conducted, with scores of adapted Oxman and Guyatt scale ≥ 14. The reviews differed in criteria for avoiding bias and assessing the validity of the primary studies. Many primary studies displayed major methodological flaws, such as randomization, allocation concealment, and dropouts and withdrawals. According to the concordance assessment, laparoscopy-assisted gastrectomy (LAG) was superior to open gastrectomy, and laparoscopy-assisted distal gastrectomy was superior to open distal gastrectomy in short-term outcomes. However, the concordance regarding other surgical interventions, such as D1 vs. D2 lymphadenectomy, and robotic gastrectomy vs. LAG were absent. Systematic reviews on surgical interventions for GC displayed relatively high methodological quality. The improvement of methodological quality and reporting was necessary for primary studies. The superiority of laparoscopic over open surgery was demonstrated. But concordance on other surgical interventions was rare, which needed more well-designed RCTs and systematic reviews.

Evaluating Intervention Effects in a Diagnostic Classification Model Framework

Science.gov (United States)

Madison, Matthew J.; Bradshaw, Laine

2018-01-01

The evaluation of intervention effects is an important objective of educational research. One way to evaluate the effectiveness of an intervention is to conduct an experiment that assigns individuals to control and treatment groups. In the context of pretest/posttest designed studies, this is referred to as a control-group pretest/posttest design.…

Antenatal interventions for preventing the transmission of cytomegalovirus (CMV) from the mother to fetus during pregnancy and adverse outcomes in the congenitally infected infant.

LENUS (Irish Health Repository)

McCarthy, Fergus P

2012-01-31

BACKGROUND: Cytomegalovirus (CMV) is a herpesvirus and the most common cause of congenital infection in developed countries. Congenital CMV infection can have devastating consequences to the fetus. The high incidence and the serious morbidity associated with congenital CMV infection emphasise the need for effective interventions to prevent the antenatal transmission of CMV infection. OBJECTIVES: The aim of this review was to assess the benefits and harms of interventions used during pregnancy to prevent mother to fetus transmission of CMV infection. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group\\'s Trials Register (31 December 2010). SELECTION CRITERIA: All randomised controlled trials (RCTs) and quasi RCTs investigating antenatal interventions for preventing the transmission of CMV from the mother to fetus during pregnancy and adverse outcomes in the congenitally infected infant. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion. MAIN RESULTS: We identified six studies from the search. None of these studies met the pre-defined criteria for inclusion in this review. AUTHORS\\' CONCLUSIONS: To date, no RCTs are available that examine antenatal interventions for preventing the transmission of CMV from the infected mother to fetus during pregnancy and adverse outcomes in the congenitally infected infant. Further research is needed to assess the efficacy of interventions aimed at preventing the transmission of CMV from the mother to fetus during pregnancy including a long-term follow-up of exposed infants and a cost effective analysis.

Interventions to Educate Family Physicians to Change Test Ordering

Directory of Open Access Journals (Sweden)

Roger Edmund Thomas MD, PhD, CCFP, MRCGP

2016-03-01

Full Text Available The purpose is to systematically review randomised controlled trials (RCTs to change family physicians’ laboratory test-ordering. We searched 15 electronic databases (no language/date limitations. We identified 29 RCTs (4,111 physicians, 175,563 patients. Six studies specifically focused on reducing unnecessary tests, 23 on increasing screening tests. Using Cochrane methodology 48.5% of studies were low risk-of-bias for randomisation, 7% concealment of randomisation, 17% blinding of participants/personnel, 21% blinding outcome assessors, 27.5% attrition, 93% selective reporting. Only six studies were low risk for both randomisation and attrition. Twelve studies performed a power computation, three an intention-to-treat analysis and 13 statistically controlled clustering. Unweighted averages were computed to compare intervention/control groups for tests assessed by >5 studies. The results were that fourteen studies assessed lipids (average 10% more tests than control, 14 diabetes (average 8% > control, 5 cervical smears, 2 INR, one each thyroid, fecal occult-blood, cotinine, throat-swabs, testing after prescribing, and urine-cultures. Six studies aimed to decrease test groups (average decrease 18%, and two to increase test groups. Intervention strategies: one study used education (no change: two feedback (one 5% increase, one 27% desired decrease; eight education + feedback (average increase in desired direction >control 4.9%, ten system change (average increase 14.9%, one system change + feedback (increases 5-44%, three education + system change (average increase 6%, three education + system change + feedback (average 7.7% increase, one delayed testing. The conclusions are that only six RCTs were assessed at low risk of bias from both randomisation and attrition. Nevertheless, despite methodological shortcomings studies that found large changes (e.g. >20% probably obtained real change.

Predictors of treatment dropout in self-guided web-based interventions for depression: an 'individual patient data' meta-analysis.

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Karyotaki, E; Kleiboer, A; Smit, F; Turner, D T; Pastor, A M; Andersson, G; Berger, T; Botella, C; Breton, J M; Carlbring, P; Christensen, H; de Graaf, E; Griffiths, K; Donker, T; Farrer, L; Huibers, M J H; Lenndin, J; Mackinnon, A; Meyer, B; Moritz, S; Riper, H; Spek, V; Vernmark, K; Cuijpers, P

2015-10-01

It is well known that web-based interventions can be effective treatments for depression. However, dropout rates in web-based interventions are typically high, especially in self-guided web-based interventions. Rigorous empirical evidence regarding factors influencing dropout in self-guided web-based interventions is lacking due to small study sample sizes. In this paper we examined predictors of dropout in an individual patient data meta-analysis to gain a better understanding of who may benefit from these interventions. A comprehensive literature search for all randomized controlled trials (RCTs) of psychotherapy for adults with depression from 2006 to January 2013 was conducted. Next, we approached authors to collect the primary data of the selected studies. Predictors of dropout, such as socio-demographic, clinical, and intervention characteristics were examined. Data from 2705 participants across ten RCTs of self-guided web-based interventions for depression were analysed. The multivariate analysis indicated that male gender [relative risk (RR) 1.08], lower educational level (primary education, RR 1.26) and co-morbid anxiety symptoms (RR 1.18) significantly increased the risk of dropping out, while for every additional 4 years of age, the risk of dropping out significantly decreased (RR 0.94). Dropout can be predicted by several variables and is not randomly distributed. This knowledge may inform tailoring of online self-help interventions to prevent dropout in identified groups at risk.

Clinical Impact Research – how to choose experimental or observational intervention study?

Science.gov (United States)

Malmivaara, Antti

2016-01-01

Abstract Background: Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. Aims: This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. Methods: The new concept is based on a narrative review of the literature and on author’s idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author’s previous work on the concepts benchmarking controlled trial and system impact research (SIR). Results: The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. Conclusions: CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messagesThe new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals.The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study

Antenatal and intrapartum interventions for preventing cerebral palsy: an overview of Cochrane systematic reviews.

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Shepherd, Emily; Salam, Rehana A; Middleton, Philippa; Makrides, Maria; McIntyre, Sarah; Badawi, Nadia; Crowther, Caroline A

2017-08-08

Cerebral palsy is an umbrella term encompassing disorders of movement and posture, attributed to non-progressive disturbances occurring in the developing fetal or infant brain. As there are diverse risk factors and causes, no one strategy will prevent all cerebral palsy. Therefore, there is a need to systematically consider all potentially relevant interventions for their contribution to prevention. To summarise the evidence from Cochrane reviews regarding the effects of antenatal and intrapartum interventions for preventing cerebral palsy. We searched the Cochrane Database of Systematic Reviews on 7 August 2016, for reviews of antenatal or intrapartum interventions reporting on cerebral palsy. Two authors assessed reviews for inclusion, extracted data, assessed review quality, using AMSTAR and ROBIS, and quality of the evidence, using the GRADE approach. We organised reviews by topic, and summarised findings in text and tables. We categorised interventions as effective (high-quality evidence of effectiveness); possibly effective (moderate-quality evidence of effectiveness); ineffective (high-quality evidence of harm or of lack of effectiveness); probably ineffective (moderate-quality evidence of harm or of lack of effectiveness); and no conclusions possible (low- to very low-quality evidence). We included 15 Cochrane reviews. A further 62 reviews pre-specified the outcome cerebral palsy in their methods, but none of the included randomised controlled trials (RCTs) reported this outcome. The included reviews were high quality and at low risk of bias. They included 279 RCTs; data for cerebral palsy were available from 27 (10%) RCTs, involving 32,490 children. They considered interventions for: treating mild to moderate hypertension (two) and pre-eclampsia (two); diagnosing and preventing fetal compromise in labour (one); preventing preterm birth (four); preterm fetal maturation or neuroprotection (five); and managing preterm fetal compromise (one). Quality of

Couples-based interventions following prostate cancer treatment: a narrative review

Science.gov (United States)

Emanu, Jessica C.; Avildsen, Isabelle

2015-01-01

Background Sexual dysfunction following prostate cancer (PC) treatment often results in sexual avoidance and a loss of sexual intimacy, which can lead to relationship distress. This review aims to evaluate six studies intended to address relational and sexual intimacy following PC treatment and discuss methodological concerns which may help produce more effective interventions. Methods Electronic databases used to conduct literature searches included Medline, PsychINFO, and Web of Science. Studies were included if they were: randomized controlled trials (RCTs) using samples of men diagnosed with PC of any stage, had a psychosocial intervention, and addressed at least one sexual and relational outcome. Results As a whole, the literature has produced mixed results. While significant findings were reported, many of the primary hypotheses were not achieved. The six studies show that men with PC may benefit from education and support related to treatment options for erectile dysfunction (ED), whereas their partners may benefit more from interventions focused on relational issues. Important methodological limitations included: selection of general outcome measures as opposed to measures specific to sexuality or intimacy outcomes, lack of assessing distress or bother of the patient/couples as study entry criteria, heterogeneity of study populations, and lack of innovative intervention content as the current studies tested standard educational interventions, sex therapies techniques, and couples therapy strategies with only marginal success. Conclusions Interventions based on innovative theoretical approaches as well as study designs that address the outlined methodological limitations are needed in this area. PMID:26813683

Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

Science.gov (United States)

Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

2015-12-01

Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Event Rates in Randomized Clinical Trials Evaluating Cardiovascular Interventions and Devices

NARCIS (Netherlands)

Mahmoud, Karim D.; Lennon, Ryan J.; Holmes, David R.

2015-01-01

Randomized clinical trials (RCTs) are considered the gold standard for evidence-based medicine. However, an accurate estimation of the event rate is crucial for their ability to test clinical hypotheses. Overestimation of event rates reduces the required sample size but can compromise the

Systematic overview of economic evaluations of health-related rehabilitation.

Science.gov (United States)

Howard-Wilsher, Stephanie; Irvine, Lisa; Fan, Hong; Shakespeare, Tom; Suhrcke, Marc; Horton, Simon; Poland, Fiona; Hooper, Lee; Song, Fujian

2016-01-01

Health related rehabilitation is instrumental in improving functioning and promoting participation by people with disabilities. To make clinical and policy decisions about health-related rehabilitation, resource allocation and cost issues need to be considered. To provide an overview of systematic reviews (SRs) on economic evaluations of health-related rehabilitation. We searched multiple databases to identify relevant SRs of economic evaluations of health-related rehabilitation. Review quality was assessed by AMSTAR checklist. We included 64 SRs, most of which included economic evaluations alongside randomized controlled trials (RCTs). The review quality was low to moderate (AMSTAR score 5-8) in 35, and high (score 9-11) in 29 of the included SRs. The included SRs addressed various health conditions, including spinal or other pain conditions (n = 14), age-related problems (11), stroke (7), musculoskeletal disorders (6), heart diseases (4), pulmonary (3), mental health problems (3), and injury (3). Physiotherapy was the most commonly evaluated rehabilitation intervention in the included SRs (n = 24). Other commonly evaluated interventions included multidisciplinary programmes (14); behavioral, educational or psychological interventions (11); home-based interventions (11); complementary therapy (6); self-management (6); and occupational therapy (4). Although the available evidence is often described as limited, inconsistent or inconclusive, some rehabilitation interventions were cost-effective or showed cost-saving in a variety of disability conditions. Available evidence comes predominantly from high income countries, therefore economic evaluations of health-related rehabilitation are urgently required in less resourced settings. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Organisational interventions for improving wellbeing and reducing work-related stress in teachers.

Science.gov (United States)

Naghieh, Ali; Montgomery, Paul; Bonell, Christopher P; Thompson, Marc; Aber, J Lawrence

2015-04-08

The teaching profession is an occupation with a high prevalence of work-related stress. This may lead to sustained physical and mental health problems in teachers. It can also negatively affect the health, wellbeing and educational attainment of children, and impose a financial burden on the public budget in terms of teacher turnover and sickness absence. Most evaluated interventions for the wellbeing of teachers are directed at the individual level, and so do not tackle the causes of stress in the workplace. Organisational-level interventions are a potential avenue in this regard. To evaluate the effectiveness of organisational interventions for improving wellbeing and reducing work-related stress in teachers. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, ASSIA, AEI, BEI, BiblioMap, DARE, DER, ERIC, IBSS, SSCI, Sociological Abstracts, a number of specialist occupational health databases, and a number of trial registers and grey literature sources from the inception of each database until January 2015. Randomised controlled trials (RCTs), cluster-RCTs, and controlled before-and-after studies of organisational-level interventions for the wellbeing of teachers. We used standard methodological procedures expected by Cochrane. Four studies met the inclusion criteria. They were three cluster-randomised controlled trials and one with a stepped-wedge design.Changing task characteristicsOne study with 961 teachers in eight schools compared a task-based organisational change intervention along with stress management training to no intervention. It found a small reduction at 12 months in 10 out of 14 of the subscales in the Occupational Stress Inventory, with a mean difference (MD) varying from -3.84 to 0.13, and a small increase in the Work Ability Index (MD 2.27; 95% confidence interval (CI) 1.64 to 2.90; 708 participants, low-quality evidence).Changing organisational characteristicsTwo studies compared teacher

A systematic review of online interventions for mental health in low and middle income countries: a neglected field.

Science.gov (United States)

Arjadi, R; Nauta, M H; Chowdhary, N; Bockting, C L H

2015-01-01

Low and middle income countries (LMICs) are facing an increase of the impact of mental health problems while confronted with limited resources and limited access to mental health care, known as the 'mental health gap'. One strategy to reduce the mental health gap would be to utilize the internet to provide more widely-distributed and low cost mental health care. We undertook this systematic review to investigate the effectiveness and efficacy of online interventions in LMICs. We systematically searched the data-bases PubMed, PsycINFO, JMIR, and additional sources. MeSH terms, Thesaurus, and free text keywords were used. We included all randomized controlled trials (RCTs) of online interventions in LMICs. We found only three articles reported results of RCTs on online interventions for mental health conditions in LMICs, but none of these interventions was compared with an active control condition. Also, the mental health conditions were diverse across the three studies. There is a dearth of studies examining the effect of online interventions in LMICs, so we cannot draw a firm conclusion on its effectiveness. However, given the effectiveness of online interventions in high income countries and sharp increase of internet access in LMICs, online interventions may offer a potential to help reduce the 'mental health gap'. More studies are urgently needed in LMICs.

Shifting effects in randomised controlled trials of complex interventions: a new kind of performance bias?

Science.gov (United States)

Gold, C; Erkkilä, J; Crawford, M J

2012-11-01

Randomised controlled trials (RCTs) aim to provide unbiased estimates of treatment effects. However, the process of implementing trial procedures may have an impact on the performance of complex interventions that rely strongly on the intuition and confidence of therapists. We aimed to examine whether shifting effects over the recruitment period can be observed that might indicate such impact. Three RCTs investigating music therapy vs. standard care were included. The intervention was performed by experienced therapists and based on established methods. We examined outcomes of participants graphically, analysed cumulative effects and tested for differences between first vs. later participants. We tested for potential confounding population shifts through multiple regression models. Cumulative differences suggested trends over the recruitment period. Effect sizes tended to be less favourable among the first participants than later participants. In one study, effects even changed direction. Age, gender and baseline severity did not account for these shifting effects. Some trials of complex interventions have shifting effects over the recruitment period that cannot be explained by therapist experience or shifting demographics. Replication and further research should aim to find out which interventions and trial designs are most vulnerable to this new kind of performance bias. © 2012 John Wiley & Sons A/S.

Can smartphone mental health interventions reduce symptoms of anxiety? A meta-analysis of randomized controlled trials.

Science.gov (United States)

Firth, Joseph; Torous, John; Nicholas, Jennifer; Carney, Rebekah; Rosenbaum, Simon; Sarris, Jerome

2017-08-15

Various psychological interventions are effective for reducing symptoms of anxiety when used alone, or as an adjunct to anti-anxiety medications. Recent studies have further indicated that smartphone-supported psychological interventions may also reduce anxiety, although the role of mobile devices in the treatment and management of anxiety disorders has yet to be established. We conducted a systematic review and meta-analysis of all randomized clinical trials (RCTs) reporting the effects of psychological interventions delivered via smartphone on symptoms of anxiety (sub-clinical or diagnosed anxiety disorders). A systematic search of major electronic databases conducted in November 2016 identified 9 eligible RCTs, with 1837 participants. Random-effects meta-analyses were used to calculate the standardized mean difference (as Hedges' g) between smartphone interventions and control conditions. Significantly greater reductions in total anxiety scores were observed from smartphone interventions than control conditions (g=0.325, 95% C.I.=0.17-0.48, psmartphone interventions were significantly greater when compared to waitlist/inactive controls (g=0.45, 95% C.I.=0.30-0.61, psmartphone interventions can match (or exceed) the efficacy of recognised treatments for anxiety has yet to established. This meta-analysis shows that psychological interventions delivered via smartphone devices can reduce anxiety. Future research should aim to develop pragmatic methods for implementing smartphone-based support for people with anxiety, while also comparing the efficacy of these interventions to standard face-to-face psychological care. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Evaluation of medical radiation exposure in pediatric interventional radiology procedures

Energy Technology Data Exchange (ETDEWEB)

Navarro, Valeria Coelho Costa; Navarro, Marcus Vinicius Teixeira; Oliveira, Aline da Silva Pacheco, E-mail: vccnavarro@gmail.com [Instituto Federal de Educacao, Ciencia e Tecnologia da Bahia (IFBA), Salvador, BA (Brazil); Maia, Ana Figueiredo [Universidade Federal de Sergipe (UFS), Aracaju, SE (Brazil); Oliveira, Adriano Dias Dourado [Sociedade Brasileira de Hemodinamica e Cardiologia Intervencionista, Salvador, BA (Brazil)

2012-07-15

Objective: To evaluate pediatric radiation exposure in procedures of interventional radiology in two hospitals in the Bahia state, aiming at contributing to delineate the scenario at the state and national levels. The knowledge of exposure levels will allow an evaluation of the necessity of doses optimization, considering that peculiarities of radiology and pediatrics become even more significant in interventional radiology procedures which involve exposure to higher radiation doses. Materials and Methods: A total of 32 procedures were evaluated in four rooms of the two main hospitals performing pediatric interventional radiology procedures in the Bahia state. Air kerma rate and kerma-area product were evaluated in 27 interventional cardiac and 5 interventional brain procedures. Results: Maximum values for air kerma rate and kerma-area product and air kerma obtained in cardiac procedures were, respectively, 129.9 Gy.cm{sup 2} and 947.0 mGy; and, for brain procedures were 83.3 Gy.cm{sup 2} and 961.0 mGy. Conclusion: The present study results showed exposure values up to 14 times higher than those found in other foreign studies, and approximating those found for procedures in adults. Such results demonstrate excessive exposure to radiation, indicating the need for constant procedures optimization and evaluation of exposure rates. (author)

Protocol for a systematic review of psychological interventions for cancer-related fatigue in post-treatment cancer survivors.

Science.gov (United States)

Corbett, Teresa; Devane, Declan; Walsh, Jane C; Groarke, AnnMarie; McGuire, Brian E

2015-12-04

Fatigue is a common symptom in cancer patients that can persist beyond the curative treatment phase. Some evidence has been reported for interventions for fatigue during active treatment. However, to date, there is no systematic review on psychological interventions for fatigue after the completion of curative treatment for cancer. This is a protocol for a systematic review that aims to evaluate the effectiveness of psychological interventions for cancer-related fatigue in post-treatment cancer survivors. This systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) database. We will search the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and relevant sources of grey literature. Randomised controlled trials (RCTs) which have evaluated psychological interventions in adult cancer patients after the completion of treatment, with fatigue as an outcome measure, will be included. Two review authors will independently extract data from the selected studies and assess the methodological quality using the Cochrane Collaboration Risk of Bias Tool. Most existing evidence on cancer-related fatigue is from those in active cancer treatment. This systematic review and meta-analysis will build upon previous evaluations of psychological interventions in people during and after cancer treatment. With the growing need for stage-specific research in cancer, this review seeks to highlight a gap in current practice and to strengthen the evidence base of randomised controlled trials in the area. PROSPERO CRD42014015219.

Efficacy of group social skills interventions for youth with autism spectrum disorder: A systematic review and meta-analysis.

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Gates, Jacquelyn A; Kang, Erin; Lerner, Matthew D

2017-03-01

Group-based social skills interventions (GSSIs) are widely used for treating social competence among youth with autism spectrum disorder (ASD), but their efficacy is unclear. Previous meta-analysis of the literature on well-designed trials of GSSIs is limited in size and scope, collapsing across highly heterogeneous sources (parents; youths; teachers; observers; behavioral tasks). The current meta-analysis of randomized control trials (RCTs) was conducted to ascertain overall effectiveness of GSSIs and differences by reporting sources. Nineteen RCTs met inclusion criteria. Results show that overall positive aggregate effects were medium (g=0.51, pskilled social behaviors (social knowledge; g=1.15, psocial performance; g=0.28, p=0.31). Social skills interventions presently appear modestly effective for youth with ASD, but may not generalize to school settings or self-reported social behavior. Copyright © 2017 Elsevier Ltd. All rights reserved.

Nutritional interventions for preventing and treating pressure ulcers.

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Langer, Gero; Fink, Astrid

2014-06-12

Pressure ulcers affect approximately 10% of people in hospitals and older people are at highest risk. A correlation between inadequate nutritional intake and the development of pressure ulcers has been suggested by several studies, but the results have been inconsistent. To evaluate the effects of enteral and parenteral nutrition on the prevention and treatment of pressure ulcers. In March 2014, for this first update, we searched The Cochrane Wounds Group Specialised Trials Register, the Cochrane Central register of Controlled Trials (The Cochrane Library), the Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library), the Health Technology Assessment Database (HTA) (The Cochrane Library), the Cochrane Methodology Register (The Cochrane Library), NHS Economic Evaluation Database (The Cochrane Library), Ovid Medline, Ovid Embase and EBSCO CINAHL. No date, language or publication status limits were applied. Randomised controlled trials (RCTs) evaluating the effects of enteral or parenteral nutrition on the prevention and treatment of pressure ulcers, which measured the incidence of new ulcers, ulcer healing or changes in pressure ulcer severity. There were no restrictions on types of patient, setting, date, publication status or language. Two review authors independently screened for inclusion, and disagreement was resolved by discussion. Two review authors independently extracted data and assessed quality using the Cochrane Collaboration tool for assessing risk of bias. We included 23 RCTs, many were small (between 9 and 4023 participants, median 88) and at high risk of bias.Eleven trials compared a combination of nutritional supplements, consisting of a minimum of energy and protein in different dosages, for the prevention of pressure ulcers. A meta-analysis of eight trials (6062 participants) that compared the effects of mixed nutritional supplements with standard hospital diet found no clear evidence of an effect of supplementation on pressure

Interventions for preventing voice disorders in adults.

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Ruotsalainen, J H; Sellman, J; Lehto, L; Jauhiainen, M; Verbeek, J H

2007-10-17

Poor voice quality due to a voice disorder can lead to a reduced quality of life. In occupations where voice use is substantial it can lead to periods of absence from work. To evaluate the effectiveness of interventions to prevent voice disorders in adults. We searched MEDLINE (PubMed, 1950 to 2006), EMBASE (1974 to 2006), CENTRAL (The Cochrane Library, Issue 2 2006), CINAHL (1983 to 2006), PsychINFO (1967 to 2006), Science Citation Index (1986 to 2006) and the Occupational Health databases OSH-ROM (to 2006). The date of the last search was 05/04/06. Randomised controlled clinical trials (RCTs) of interventions evaluating the effectiveness of treatments to prevent voice disorders in adults. For work-directed interventions interrupted time series and prospective cohort studies were also eligible. Two authors independently extracted data and assessed trial quality. Meta-analysis was performed where appropriate. We identified two randomised controlled trials including a total of 53 participants in intervention groups and 43 controls. One study was conducted with teachers and the other with student teachers. Both trials were poor quality. Interventions were grouped into 1) direct voice training, 2) indirect voice training and 3) direct and indirect voice training combined.1) Direct voice training: One study did not find a significant decrease of the Voice Handicap Index for direct voice training compared to no intervention.2) Indirect voice training: One study did not find a significant decrease of the Voice Handicap Index for indirect voice training when compared to no intervention.3) Direct and indirect voice training combined: One study did not find a decrease of the Voice Handicap Index for direct and indirect voice training combined when compared to no intervention. The same study did however find an improvement in maximum phonation time (Mean Difference -3.18 sec; 95 % CI -4.43 to -1.93) for direct and indirect voice training combined when compared to no

Pharmacological interventions for sleepiness and sleep disturbances caused by shift work

Directory of Open Access Journals (Sweden)

Juha Liira

Full Text Available BACKGROUND: Shift work results in sleep-wake disturbances, which cause sleepiness during night shifts and reduce sleep length and quality in daytime sleep after the night shift. In its serious form it is also called shift work sleep disorder. Various pharmacological products are used to ameliorate symptoms of sleepiness or poor sleep length and quality. OBJECTIVES: To evaluate the effects of pharmacological interventions to reduce sleepiness or to improve alertness at work and decrease sleep disturbances whilst of work, or both, in workers undertaking shift work. METHODS: Search methods: We searched CENTRAL, MEDLINE, EMBASE, PubMed and PsycINFO up to 20 September 2013 and ClinicalTrials.gov up to July 2013. We also screened reference lists of included trials and relevant reviews. Selection criteria: We included all eligible randomised controlled trials (RCTs, including cross-over RCTs, of pharmacological products among workers who were engaged in shift work (including night shifts in their present jobs and who may or may not have had sleep problems. Primary outcomes were sleep length and sleep quality while of work, alertness and sleepiness, or fatigue at work. Data collection and analysis: Two authors independently selected studies, extracted data and assessed risk of bias in included trials. We performed meta-analyses where appropriate. MAIN RESULTS: We included 15 randomised placebo-controlled trials with 718 participants. Nine trials evaluated the effect of melatonin and two the effect of hypnotics for improving sleep problems. One trial assessed the effect of modafinil, two of armodafinil and one examined cafeine plus naps to decrease sleepiness or to increase alertness.

Evaluations of Structural Interventions for HIV Prevention: A Review of Approaches and Methods.

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Iskarpatyoti, Brittany S; Lebov, Jill; Hart, Lauren; Thomas, Jim; Mandal, Mahua

2018-04-01

Structural interventions alter the social, economic, legal, political, and built environments that underlie processes affecting population health. We conducted a systematic review of evaluations of structural interventions for HIV prevention in low- and middle-income countries (LMICs) to better understand methodological and other challenges and identify effective evaluation strategies. We included 27 peer-reviewed articles on interventions related to economic empowerment, education, and substance abuse in LMICs. Twenty-one evaluations included clearly articulated theories of change (TOCs); 14 of these assessed the TOC by measuring intermediary variables in the causal pathway between the intervention and HIV outcomes. Although structural interventions address complex interactions, no evaluation included methods designed to evaluate complex systems. To strengthen evaluations of structural interventions, we recommend clearly articulating a TOC and measuring intermediate variables between the predictor and outcome. We additionally recommend adapting study designs and analytic methods outside traditional epidemiology to better capture complex results, influences external to the intervention, and unintended consequences.

Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital

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Rooshenas, Leila; Fairhurst, Katherine; Rees, Jonathan; Gamble, Carrol; Blazeby, Jane M

2018-01-01

Objectives To examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature. Design Studies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls; www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study. Results Of 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more ‘real’ RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent. Conclusion There is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment. PMID:29420230

Behaviour modification interventions to optimise red blood cell transfusion practices: a systematic review and meta-analysis.

Science.gov (United States)

Soril, Lesley J J; Noseworthy, Thomas W; Dowsett, Laura E; Memedovich, Katherine; Holitzki, Hannah M; Lorenzetti, Diane L; Stelfox, Henry Thomas; Zygun, David A; Clement, Fiona M

2018-05-18

To assess the impact of behaviour modification interventions to promote restrictive red blood cell (RBC) transfusion practices. Systematic review and meta-analysis. Seven electronic databases were searched to January 2018. Published randomised controlled trials (RCTs) or non-randomised studies examining an intervention to modify healthcare providers' RBC transfusion practice in any healthcare setting were included. The primary outcome was the proportion of patients transfused. Secondary outcomes included the proportion of inappropriate transfusions, RBC units transfused per patient, in-hospital mortality, length of stay (LOS), pretransfusion haemoglobin and healthcare costs. Meta-analysis was conducted using a random-effects model and meta-regression was performed in cases of heterogeneity. Publication bias was assessed by Begg's funnel plot. Eighty-four low to moderate quality studies were included: 3 were RCTs and 81 were non-randomised studies. Thirty-one studies evaluated a single intervention, 44 examined a multimodal intervention. The comparator in all studies was standard of care or historical control. In 33 non-randomised studies, use of an intervention was associated with reduced odds of transfusion (OR 0.63 (95% CI 0.56 to 0.71)), odds of inappropriate transfusion (OR 0.46 (95% CI 0.36 to 0.59)), RBC units/patient weighted mean difference (WMD: -0.50 units (95% CI -0.85 to -0.16)), LOS (WMD: -1.14 days (95% CI -2.12 to -0.16)) and pretransfusion haemoglobin (-0.28 g/dL (95% CI -0.48 to -0.08)). There was no difference in odds of mortality (OR 0.90 (95% CI 0.80 to 1.02)). Protocol/algorithm and multimodal interventions were associated with the greatest decreases in the primary outcome. There was high heterogeneity among estimates and evidence for publication bias. The literature examining the impact of interventions on RBC transfusions is extensive, although most studies are non-randomised. Despite this, pooled analysis of 33 studies revealed

The Evidence for Dietary Interventions and Nutritional Supplements as Treatment Options in Multiple Sclerosis: a Review.

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Mische, Leah J; Mowry, Ellen M

2018-03-17

This review aims to critically evaluate published studies examining diets and nutritional supplements (excepting vitamin D) for the impact on prevention and prognosis of multiple sclerosis (MS). There is a negative relationship between the Mediterranean diet and vascular disease, and vascular co-morbidities are associated with a worse MS prognosis. Low-fat, fish-based diets, sodium-restricted diets, calorie restriction, the paleo diet, and gluten-free diets have been examined, mostly in observational studies; results are inconclusive. With regard to nutritional supplements, pilot data show a possible benefit of biotin with respect to disability worsening in people with progressive MS (PMS). The best designed randomized controlled trials (RCTs) for PUFA supplementation have not shown significant impact, but several weaker RCTs have. Many other nutritional supplements have been tested, including several anti-oxidants. While some early studies show positive results, no result has been definitive. Unfortunately, there is no strong evidence for a direct benefit of any given dietary intervention on MS risk or prognosis. However, due to its relationship with vascular co-morbidities, the Mediterranean diet has the strongest rationale for employment in PwMS. Higher-quality clinical trials are needed to ascertain the possible benefits of nutritional supplements.

Behavioural physical activity interventions in participants with lower-limb osteoarthritis: a systematic review with meta-analysis.

Science.gov (United States)

Williamson, Wilby; Kluzek, Stefan; Roberts, Nia; Richards, Justin; Arden, Nigel; Leeson, Paul; Newton, Julia; Foster, Charlie

2015-08-10

To assess effectiveness of osteoarthritis interventions to promote long-term physical activity behaviour change. A systematic review and meta-analysis. Protocol registration PROSPERO CRD4201300444 5 (http://www.crd.york.ac.uk/prospero/). Randomised controlled trials (RCTs) comparing physical activity interventions with placebo, no/or minimal intervention in community-dwelling adults with symptomatic knee or hip osteoarthritis. Primary outcomes were change in physical activity or cardiopulmonary fitness after a minimum follow-up of 6 months. Outcomes were measures of physical activity (self-reported and objectively measured) and cardiovascular fitness. Standard mean differences between postintervention values were used to describe the effect sizes. 27,984 titles were screened and 180 papers reviewed in full. Eleven RCTs satisfied inclusion criteria, total study population of 2741 participants, mean age 62.2. The commonest reasons for study exclusion were follow-up less than 6 months and no physical activity measures. The majority of included interventions implement an arthritis self-management programme targeting coping skills and self-efficacy. Seven studies used self-report measures, the pooled effect of these studies was small with significant heterogeneity between studies (SMD 0.22 with 95% CI -0.11 to 0.56, z=1.30 (p=0.19) I(2) statistic of 85%). Subgroup analysis of 6-12 month outcome reduced heterogeneity and increased intervention effect compared to control (SMD 0.53, 95% CI 0.41 to 0.65, z=8.84 (p<0.00001) I(2) of 66%). Arthritis self-management programmes achieve a small but significant improvement in physical activity in the short term. Effectiveness of intervention declines with extended follow-up beyond 12 months with no significant benefit compared to control. The small number of studies (11 RCTs) limited ability to define effective delivery methods. Investigation of behavioural lifestyle interventions for lower limb osteoarthritis populations would

A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials.

Science.gov (United States)

Chauvin, Anthony; Moher, David; Altman, Doug; Schriger, David L; Alam, Sabina; Hopewell, Sally; Shanahan, Daniel R; Recchioni, Alessandro; Ravaud, Philippe; Boutron, Isabelle

2017-09-15

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. 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'. First, we will develop an online tool and training module based (a) on the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the Explanation and Elaboration document that would be dedicated to junior peer reviewers for assessing the completeness of reporting of key items and (b) the Centre for Evidence-Based Medicine Outcome Monitoring Project process used to identify switched outcomes in completed reports of the primary results of RCTs when initially submitted. Then, we will compare the performance of early career peer reviewers who use the online tool to the usual peer review process in identifying inadequate reporting and switched outcomes in completed reports of RCTs at initial journal submission. The primary outcome will be the mean number of items accurately classified per manuscript. The secondary outcomes will be the mean number of items accurately classified per manuscript for the CONSORT items and the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify a switch in outcomes. We aim to include 120 RCTs and 120 early career peer reviewers. The research protocol was approved by the ethics committee of the INSERM Institutional Review Board (21 January 2016). The study is based on voluntary

A systematic review of immunosuppressant adherence interventions in transplant recipients: Decoding the streetlight effect.

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Duncan, S; Annunziato, R A; Dunphy, C; LaPointe Rudow, D; Shneider, B L; Shemesh, E

2018-02-01

Non-adherence to immunosuppressant medications is an important risk factor for graft dysfunction. To evaluate the effectiveness of adherence-enhancing interventions, we reviewed adherence intervention studies in solid organ transplant recipients (all ages). Using the following databases: PsycINFO, PubMed, Scopus, and ScienceDirect, we identified 41 eligible studies. Only three non-randomized trials showed a possible positive effect on objective indicators of transplant outcomes (such as rejection, liver enzyme levels, kidney function). None of the 21 RCTs showed an improvement in transplant outcomes. Three studies showed a higher rate of adverse events in the intervention group as compared with controls, although this may be related to ascertainment bias. Improvement in adherence as measured indirectly (eg, with electronic monitoring devices) was not aligned with effects on transplant outcomes. We conclude that adherence interventions, to date, have largely been ineffective in improving transplant outcomes. To improve this track record, intervention efforts may wish to concentrate on non-adherent patients (rather than use convenience sampling, which excludes many of the patients who need the intervention), use direct measures of adherence to guide the interventions, and employ strategies that are intensive and yet engaging enough to ensure that non-adherent patients are able to participate. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Systematic review and meta-analyses of psychosocial interventions for veterans of the military

Directory of Open Access Journals (Sweden)

Neil J. Kitchiner

2012-12-01

Full Text Available Background: The efficacy of psychosocial therapies for common mental health disorders in veterans is unclear and requires further examination. Method: Systematic review and meta-analyses of randomised controlled trials (RCTs. Twenty databases were searched. Studies were included if they reported a psychosocial intervention designed to treat or reduce common mental health symptoms in veterans identified as being symptomatic at the time they entered the study. Studies of substance dependency disorders and psychosis were excluded. Eligible studies were assessed against methodological quality criteria and data were extracted and analysed. Results: Twenty-nine RCTs were identified. There was evidence for the use of trauma-focused therapies for post-traumatic stress disorder (PTSD and some evidence for psychological interventions in the treatment of borderline personality disorder, depression, insomnia, and panic disorder co-morbid to PTSD. However, methodological quality of many of the studies was less than optimal. Conclusions: Trauma-focused psychological therapies are likely to be effective for combat-related PTSD but there is a need for more research to determine the efficacy of psychological treatments for other mental health disorders in veterans.

Psychosocial interventions for internalised stigma in people with a schizophrenia-spectrum diagnosis: A systematic narrative synthesis and meta-analysis.

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Wood, Lisa; Byrne, Rory; Varese, Filippo; Morrison, Anthony P

2016-10-01

It is acknowledged that people with a schizophrenia-spectrum diagnosis experience higher levels of stigma compared to any other mental health diagnosis. As a consequence, their experience of internalised stigma is likely to be the most detrimental and pervasive. Internalised stigma interventions have shown some benefits in those who experience serious mental illness including those with a schizophrenia-spectrum diagnosis. A systematic narrative review and meta-analysis were conducted examining the efficacy of internalised stigma interventions for people with a schizophrenia-spectrum diagnosis. Randomised Controlled Trials, controlled trials, and cohort studies were included and assessed against quality criteria. The search identified 12 studies; 7 randomised controlled trials, 3 cohort studies and 2 controlled trials. A variety of psychosocial interventions were utilised with the majority employing Cognitive Behaviour Therapy (CBT), psychoeducation and social skills training. The core outcomes used to examine the efficacy of the intervention were internalised stigma, self-esteem, empowerment, and functioning. The meta-analysis revealed an improvement in internalised stigma favouring the internalised stigma intervention but was not significant (5 RCTs, n=200). Self-efficacy and insight were significantly improved favouring the internalised stigma intervention. Internalised stigma interventions show promise in those with schizophrenia-spectrum diagnoses. Existing interventions have demonstrated small effects and employed small samples. Large scale RCTs are required to further develop the evidence base of more targeted interventions. Copyright © 2016 Elsevier B.V. All rights reserved.

Legislative, educational, policy and other interventions targeting physicians' interaction with pharmaceutical companies: a systematic review.

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Alkhaled, Lina; Kahale, Lara; Nass, Hala; Brax, Hneine; Fadlallah, Racha; Badr, Kamal; Akl, Elie A

2014-07-01

Pharmaceutical company representatives likely influence the prescribing habits and professional behaviour of physicians. The objective of this study was to systematically review the effects of interventions targeting practising physicians' interactions with pharmaceutical companies. We included observational studies, non-randomised controlled trials (non-RCTs) and RCTs evaluating legislative, educational, policy or other interventions targeting the interactions between physicians and pharmaceutical companies. The search strategy included an electronic search of MEDLINE and EMBASE. Two reviewers performed duplicate and independent study selection, data abstraction and assessment of risk of bias. We assessed the risk of bias in each included study. We summarised the findings narratively because the nature of the data did not allow a meta-analysis to be conducted. We assessed the quality of evidence by outcome using the GRADE methodology. Of 11 189 identified citations, one RCT and three observational studies met the eligibility criteria. All four studies specifically targeted one type of interaction with pharmaceutical companies, that is, interactions with drug representatives. The RCT provided moderate quality evidence of no effect of a 'collaborative approach' between the pharmaceutical industry and a health authority. The three observational studies provided low quality evidence suggesting a positive effect of policies aiming to reduce interaction between physicians and pharmaceutical companies (by restricting free samples, promotional material, and meetings with pharmaceutical company representatives) on prescription behaviour. We identified too few studies to allow strong conclusions. Available evidence suggests a potential impact of policies aiming to reduce interaction between physicians and drug representatives on physicians' prescription behaviour. We found no evidence concerning interventions affecting other types of interaction with pharmaceutical

Designing and Evaluating Interventions to Halt the Transmission of Tuberculosis.

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Dowdy, David W; Grant, Alison D; Dheda, Keertan; Nardell, Edward; Fielding, Katherine; Moore, David A J

2017-11-03

To reduce the incidence of tuberculosis, it is insufficient to simply understand the dynamics of tuberculosis transmission. Rather, we must design and rigorously evaluate interventions to halt transmission, prioritizing those interventions most likely to achieve population-level impact. Synergy in reducing tuberculosis transmission may be attainable by combining interventions that shrink the reservoir of latent Mycobacterium tuberculosis infection (preventive therapy), shorten the time between disease onset and treatment initiation (case finding and diagnosis), and prevent transmission in key settings, such as the built environment (infection control). In evaluating efficacy and estimating population-level impact, cluster-randomized trials and mechanistic models play particularly prominent roles. Historical and contemporary evidence suggests that effective public health interventions can halt tuberculosis transmission, but an evidence-based approach based on knowledge of local epidemiology is necessary for success. We provide a roadmap for designing, evaluating, and modeling interventions to interrupt the process of transmission that fuels a diverse array of tuberculosis epidemics worldwide. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults.

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Gardner, Benjamin; Smith, Lee; Lorencatto, Fabiana; Hamer, Mark; Biddle, Stuart J H

2016-01-01

Sedentary behaviour - i.e., low energy-expending waking behaviour while seated or lying down - is a health risk factor, even when controlling for physical activity. This review sought to describe the behaviour change strategies used within interventions that have sought to reduce sedentary behaviour in adults. Studies were identified through existing literature reviews, a systematic database search, and hand-searches of eligible papers. Interventions were categorised as 'very promising', 'quite promising', or 'non-promising' according to observed behaviour changes. Intervention functions and behaviour change techniques were compared across promising and non-promising interventions. Twenty-six eligible studies reported thirty-eight interventions, of which twenty (53%) were worksite-based. Fifteen interventions (39%) were very promising, eight quite promising (21%), and fifteen non-promising (39%). Very or quite promising interventions tended to have targeted sedentary behaviour instead of physical activity. Interventions based on environmental restructuring, persuasion, or education were most promising. Self-monitoring, problem solving, and restructuring the social or physical environment were particularly promising behaviour change techniques. Future sedentary reduction interventions might most fruitfully incorporate environmental modification and self-regulatory skills training. The evidence base is, however, weakened by low-quality evaluation methods; more RCTs, employing no-treatment control groups, and collecting objective data are needed.

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults

Science.gov (United States)

Gardner, Benjamin; Smith, Lee; Lorencatto, Fabiana; Hamer, Mark; Biddle, Stuart JH

2016-01-01

Sedentary behaviour – i.e., low energy-expending waking behaviour while seated or lying down – is a health risk factor, even when controlling for physical activity. This review sought to describe the behaviour change strategies used within interventions that have sought to reduce sedentary behaviour in adults. Studies were identified through existing literature reviews, a systematic database search, and hand-searches of eligible papers. Interventions were categorised as ‘very promising’, ‘quite promising’, or ‘non-promising’ according to observed behaviour changes. Intervention functions and behaviour change techniques were compared across promising and non-promising interventions. Twenty-six eligible studies reported thirty-eight interventions, of which twenty (53%) were worksite-based. Fifteen interventions (39%) were very promising, eight quite promising (21%), and fifteen non-promising (39%). Very or quite promising interventions tended to have targeted sedentary behaviour instead of physical activity. Interventions based on environmental restructuring, persuasion, or education were most promising. Self-monitoring, problem solving, and restructuring the social or physical environment were particularly promising behaviour change techniques. Future sedentary reduction interventions might most fruitfully incorporate environmental modification and self-regulatory skills training. The evidence base is, however, weakened by low-quality evaluation methods; more RCTs, employing no-treatment control groups, and collecting objective data are needed. PMID:26315814

Exercise interventions for the improvement of falls-related outcomes among older adults with diabetes mellitus: A systematic review and meta-analyses.

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Chapman, Anna; Meyer, Claudia; Renehan, Emma; Hill, Keith D; Browning, Colette J

2017-03-01

Falls as a complication of diabetes mellitus (DM) can have a major impact on the health of older adults. Previous reviews have demonstrated that certain exercise interventions are effective at reducing falls in older people; however, no studies have quantified the effectiveness of exercise interventions on falls-related outcomes among older adults with DM. A systematic search for all years to September 2015 identified available literature. Eligibility criteria included: appropriate exercise intervention/s; assessed falls-related outcomes; older adults with DM. Effect sizes were pooled using a random effects model. Positive effect sizes favoured the intervention. Ten RCTs were eligible for the meta-analyses. Exercise interventions were more effective than the control condition for static balance (0.53, 95% CI: 0.13 to 0.93), lower-limb strength (0.63, 95% CI: 0.09 to 1.18), and gait (0.59, 95% CI: 0.22 to 0.96). No RCTs assessed falls-risk; one RCT reported 12month falls-rate, with no differential treatment effect observed. Exercise interventions can improve certain falls-related outcomes among older adults with DM. Substantial heterogeneity and limited numbers of studies should be considered when interpreting results. Among older adults, where DM burden is increasing, exercise interventions may provide promising approaches to assist the improvement of falls-related outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

Effectiveness of physical therapy interventions for children with cerebral palsy: a systematic review

DEFF Research Database (Denmark)

Anttila, Heidi; Autti-Rämö, Ilona; Suoranta, Jutta

2008-01-01

BACKGROUND: To assess the effectiveness of physical therapy (PT) interventions on functioning in children with cerebral palsy (CP). METHODS: A search was made in Medline, Cinahl, PEDro and the Cochrane library for the period 1990 to February 2007. Only randomized controlled trials (RCTs) on PT...... interventions in children with diagnosed CP were included. Two reviewers independently assessed the methodological quality and extracted the data. The outcomes measured in the trials were classified using the International Classification of Functioning, Disability and Health (ICF). RESULTS: Twenty-two trials...

Effects and moderators of psychosocial interventions on quality of life, and emotional and social function in patients with cancer: An individual patient data meta‐analysis of 22 RCTs

Science.gov (United States)

Kalter, J.; Verdonck‐de Leeuw, I.M.; Sweegers, M.G.; Aaronson, N.K.; Jacobsen, P.B.; Newton, R.U.; Courneya, K.S.; Aitken, J.F.; Armes, J.; Arving, C.; Boersma, L.J.; Braamse, A.M.J.; Brandberg, Y.; Chambers, S.K.; Dekker, J.; Ell, K.; Ferguson, R.J.; Gielissen, M.F.M.; Glimelius, B.; Goedendorp, M.M.; Graves, K.D.; Heiney, S.P.; Horne, R.; Hunter, M.S.; Johansson, B.; Kimman, M.L.; Knoop, H.; Meneses, K.; Northouse, L.L.; Oldenburg, H.S.; Prins, J.B.; Savard, J.; van Beurden, M.; van den Berg, S.W.; Brug, J.

2018-01-01

Abstract Objective This individual patient data (IPD) meta‐analysis aimed to evaluate the effects of psychosocial interventions (PSI) on quality of life (QoL), emotional function (EF), and social function (SF) in patients with cancer, and to study moderator effects of demographic, clinical, personal, and intervention‐related characteristics. Methods Relevant studies were identified via literature searches in 4 databases. We pooled IPD from 22 (n = 4217) of 61 eligible randomized controlled trials. Linear mixed‐effect model analyses were used to study intervention effects on the post‐intervention values of QoL, EF, and SF (z‐scores), adjusting for baseline values, age, and cancer type. We studied moderator effects by testing interactions with the intervention for demographic, clinical, personal, and intervention‐related characteristics, and conducted subsequent stratified analyses for significant moderator variables.Results: PSI significantly improved QoL (β = 0.14,95%CI = 0.06;0.21), EF (β = 0.13,95%CI = 0.05;0.20), and SF (β = 0.10,95%CI = 0.03;0.18). Significant differences in effects of different types of PSI were found, with largest effects of psychotherapy. The effects of coping skills training were moderated by age, treatment type, and targeted interventions. Effects of psychotherapy on EF may be moderated by cancer type, but these analyses were based on 2 randomized controlled trials with small sample sizes of some cancer types. Conclusions PSI significantly improved QoL, EF, and SF, with small overall effects. However, the effects differed by several demographic, clinical, personal, and intervention‐related characteristics. Our study highlights the beneficial effects of coping skills training in patients treated with chemotherapy, the importance of targeted interventions, and the need of developing interventions tailored to the specific needs of elderly patients. PMID:29361206

Interventions for preventing recurrent urinary tract infection during pregnancy.

Science.gov (United States)

Schneeberger, Caroline; Geerlings, Suzanne E; Middleton, Philippa; Crowther, Caroline A

2012-11-14

Recurrent urinary tract infections (RUTI) are common in women who are pregnant and may cause serious adverse pregnancy outcomes for both mother and child including preterm birth and small-for-gestational-age babies. Interventions used to prevent RUTI in women who are pregnant can be pharmacological (antibiotics) or non-pharmacological (cranberry products, acupuncture, probiotics and behavioural modifications). So far little is known about the best way to prevent RUTI in pregnant women. To assess the effects of interventions for preventing recurrent urinary tract infections in pregnant women.The primary maternal outcomes were RUTI before birth (variously defined) and preterm birth (before 37 weeks). The primary infant outcomes were small-for-gestational age and total mortality. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (8 June 2012) and reference lists of retrieved articles. Published, unpublished and ongoing randomised controlled trials (RCTs), quasi-RCTs, clustered-randomised trials and abstracts of any intervention (pharmacological and non-pharmacological) for preventing RUTI during pregnancy (compared with another intervention, placebo or with usual care). Two review authors independently evaluated the one identified trial for inclusion and assessed trial quality. Two review authors extracted data. Data were checked for accuracy. The review included one trial involving 200 women. The trial compared a daily dose of nitrofurantoin and close surveillance (regular clinic visit, urine cultures and antibiotics when a positive culture was found) with close surveillance only. No significant differences were found for the primary outcomes: recurrent pyelonephritis (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.31 to 2.53, one study, 167 women), recurrent urinary tract infection before birth (RR 0.30, 95% CI 0.06 to 1.38; one study 167 women) and preterm birth (before 37 weeks) (RR 1.18, 95% CI 0.42 to 3.35; one study 147 women). The

Diet and exercise interventions for preventing gestational diabetes mellitus.

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Bain, Emily; Crane, Morven; Tieu, Joanna; Han, Shanshan; Crowther, Caroline A; Middleton, Philippa

2015-04-12

Gestational diabetes mellitus (GDM) is associated with a wide range of adverse health consequences for women and their babies in the short and long term. With an increasing prevalence of GDM worldwide, there is an urgent need to assess strategies for GDM prevention, such as combined diet and exercise interventions. To assess the effects of combined diet and exercise interventions for preventing GDM and associated adverse health consequences for women and their babies. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (11 February 2014) and reference lists of retrieved studies. We updated the search in February 2015 but these results have not yet been incorporated and are awaiting classification. Randomised controlled trials (RCTs) and cluster-RCTs assessing the effects of interventions that included diet and exercise components. We included studies where combined diet and exercise interventions were compared with no intervention (i.e. standard care).We planned to also compare diet and exercise interventions with alternative diet and/or exercise interventions but no trials were identified for this comparison. Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included studies. Data were checked for accuracy. We included 13 randomised controlled trials (involving 4983 women and their babies). We assessed the included trials as being of moderate risk of bias overall.When comparing women receiving a diet and exercise intervention with those receiving no intervention, there was no clear difference in the risk of developing GDM (average risk ratio (RR) 0.92, 95% confidence interval (CI) 0.68 to 1.23; 11 trials, 3744 women), caesarean section (RR 0.92, 95% CI 0.83 to 1.01; seven trials, 3246 women), or large-for-gestational age (RR 0.90, 95% CI 0.77 to 1.05; 2950 infants). Only one trial reported on perinatal mortality, and found no clear difference in the risk of stillbirth (RR 0.99, 95

Thirty years after Alma-Ata: a systematic review of the impact of community health workers delivering curative interventions against malaria, pneumonia and diarrhoea on child mortality and morbidity in sub-Saharan Africa

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Lewin Simon

2011-10-01

Full Text Available Abstract Background Over thirty years have passed since the Alma-Ata Declaration on primary health care in 1978. Many governments in the first decade following the declaration responded by developing national programmes of community health workers (CHWs, but evaluations of these often demonstrated poor outcomes. As many CHW programmes have responded to the HIV/AIDS pandemic, international interest in them has returned and their role in the response to other diseases should be examined carefully so that lessons can be applied to their new roles. Over half of the deaths in African children under five years of age are due to malaria, diarrhoea and pneumonia - a situation which could be addressed through the use of cheap and effective interventions delivered by CHWs. However, to date there is very little evidence from randomised controlled trials of the impacts of CHW programmes on child mortality in Africa. Evidence from non-randomised controlled studies has not previously been reviewed systematically. Methods We searched databases of published and unpublished studies for RCTs and non-randomised studies evaluating CHW programmes delivering curative treatments, with or without preventive components, for malaria, diarrhoea or pneumonia, in children in sub-Saharan Africa from 1987 to 2007. The impact of these programmes on morbidity or mortality in children under six years of age was reviewed. A descriptive analysis of interventional and contextual factors associated with these impacts was attempted. Results The review identified seven studies evaluating CHWs, delivering a range of interventions. Limited descriptive data on programmes, contexts or process outcomes for these CHW programmes were available. CHWs in national programmes achieved large mortality reductions of 63% and 36% respectively, when insecticide-treated nets and anti-malarial chemoprophylaxis were delivered, in addition to curative interventions. Conclusions CHW programmes could

A systematic review and meta-analysis of comprehensive interventions for pre-school children with autism spectrum disorder (ASD.

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Yoshiyuki Tachibana

Full Text Available There has an increasing number of published trials on psychosocial intervention programmes for pre-school children with autism spectrum disorder (ASD. To achieve better quality of unbiased evidence for the effectiveness of ASD interventions, it is necessary to conduct a comprehensive review that covers studies with adequate quality standards, such as randomised controlled trials (RCTs, and different types of intervention In this study, we categorize interventions for ASD as behavioural, social-communication focused, and multimodal developmental based on Howlin's classification of early interventions for children with ASD. The aim of this study was to compare these three models and investigate the strengths and weaknesses of each type of intervention and to identify the approaches that contribute to a successful outcome for children with autism.We performed a systematic review and meta-analysis. We included RCTs targeting children with ASD 6 years old or younger. A random effects model was used to present the effect estimate for the outcomes. This study also performed combined meta-analyses of all the three models to investigate the overall effectiveness of the intervention programmes.32 randomized controlled studies were found to be eligible for inclusion. The synthesized data included 594 children from 14 RCTs. There was no statistically significant difference in the effects on autism general symptoms between the social-communication-focused model and the multimodal developmental model (p = 0.83. The results suggest that there is evidence of an effect on 'reciprocity of social interaction towards others' (standard mean difference [95% confidential interval] = 0.53[0.29,0.78], p<0.01 and 'parental synchrony' (SMD = 0.99[0.70,1.29], p<0.01.The small number of studies included in the present study limited the ability to make inferences when comparing the three models and investigating the strengths and weaknesses of each type of intervention with

Identifying Important Gaps in Randomized Controlled Trials of Adult Cardiac Arrest Treatments: A Systematic Review of the Published Literature

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Sinha, Shashank S.; Sukul, Devraj; Lazarus, John J.; Polavarapu, Vivek; Chan, Paul S.; Neumar, Robert W.; Nallamothu, Brahmajee K.

2016-01-01

Background Cardiac arrests are a major public health concern worldwide. The extent and types of randomized controlled trials (RCTs) – our most reliable source of clinical evidence – conducted in these high-risk patients over recent years are largely unknown. Methods and Results We performed a systematic review, identifying all RCTs published in PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library from 1995 to 2014 that focused on acute treatment of non-traumatic cardiac arrest in adults. We then extracted data on the setting of study populations, types and timing of interventions studied, risk of bias, outcomes reported and how these factors have changed over time. Over this twenty-year period, 92 RCTs were published containing 64,309 patients (median, 225.5 per trial). Of these, 81 RCTs (88.0%) involved out-of-hospital cardiac arrest whereas 4 (4.3%) involved in-hospital cardiac arrest and 7 (7.6%) included both. Eighteen RCTs (19.6%) were performed in the U.S., 68 (73.9%) were performed outside the U.S., and 6 (6.5%) were performed in both settings. Thirty-eight RCTs (41.3%) evaluated drug therapy, 39 (42.4%) evaluated device therapy, and 15 (16.3%) evaluated protocol improvements. Seventy-four RCTs (80.4%) examined interventions during the cardiac arrest, 15 (16.3%) examined post-cardiac arrest treatment, and 3 (3.3%) studied both. Overall, reporting of risk of bias was limited. The most common outcome reported was ROSC: 86 (93.5%) with only 22 (23.9%) reporting survival beyond 6 months. Fifty-three RCTs (57.6%) reported global ordinal outcomes whereas 15 (16.3%) reported quality-of-life. RCTs in the last 5 years were more likely to be focused on protocol improvement and post-cardiac arrest care. Conclusions Important gaps in RCTs of cardiac arrest treatments exist, especially those examining in-hospital cardiac arrest, protocol improvement, post-cardiac arrest care, and long-term or quality-of-life outcomes. PMID:27756794

Evaluation of interventions on road traffic injuries in Peru: a qualitative approach

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2012-01-01

Background Evaluation of interventions on road traffic injuries (RTI) going beyond the assessment of impact to include factors underlying success or failure is an important complement to standard impact evaluations. We report here how we used a qualitative approach to assess current interventions implemented to reduce RTIs in Peru. Methods We performed in-depth interviews with policymakers and technical officers involved in the implementation of RTI interventions to get their insight on design, implementation and evaluation aspects. We then conducted a workshop with key stakeholders to analyze the results of in-depth interviews, and to further discuss and identify key programmatic considerations when designing and implementing RTI interventions. We finally performed brainstorming sessions to assess potential system-wide effects of a selected intervention (Zero Tolerance), and to identify adaptation and redesign needs for this intervention. Results Key programmatic components were consistently identified that should be considered when designing and implementing RTI interventions. They include effective and sustained political commitment and planning; sufficient and sustained budget allocation; training, supervision, monitoring and evaluation of implemented policies; multisectoral participation; and strong governance and accountability. Brainstorming sessions revealed major negative effects of the selected intervention on various system building blocks. Conclusions Our approach revealed substantial caveats in current RTI interventions in Peru, and fundamental negative effects on several components of the sectors and systems involved. It also highlighted programmatic issues that should be applied to guarantee an effective implementation and evaluation of these policies. The findings from this study were discussed with key stakeholders for consideration in further designing and planning RTI control interventions in Peru. PMID:22269578

Gamification and Adherence to Web-Based Mental Health Interventions: A Systematic Review.

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Brown, Menna; O'Neill, Noelle; van Woerden, Hugo; Eslambolchilar, Parisa; Jones, Matt; John, Ann

2016-08-24

Adherence to effective Web-based interventions for common mental disorders (CMDs) and well-being remains a critical issue, with clear potential to increase effectiveness. Continued identification and examination of "active" technological components within Web-based interventions has been called for. Gamification is the use of game design elements and features in nongame contexts. Health and lifestyle interventions have implemented a variety of game features in their design in an effort to encourage engagement and increase program adherence. The potential influence of gamification on program adherence has not been examined in the context of Web-based interventions designed to manage CMDs and well-being. This study seeks to review the literature to examine whether gaming features predict or influence reported rates of program adherence in Web-based interventions designed to manage CMDs and well-being. A systematic review was conducted of peer-reviewed randomized controlled trials (RCTs) designed to manage CMDs or well-being and incorporated gamification features. Seven electronic databases were searched. A total of 61 RCTs met the inclusion criteria and 47 different intervention programs were identified. The majority were designed to manage depression using cognitive behavioral therapy. Eight of 10 popular gamification features reviewed were in use. The majority of studies utilized only one gamification feature (n=58) with a maximum of three features. The most commonly used feature was story/theme. Levels and game leaders were not used in this context. No studies explicitly examined the role of gamification features on program adherence. Usage data were not commonly reported. Interventions intended to be 10 weeks in duration had higher mean adherence than those intended to be 6 or 8 weeks in duration. Gamification features have been incorporated into the design of interventions designed to treat CMD and well-being. Further research is needed to improve understanding

Efficacy of preventative parenting interventions for parents of preterm infants on later child behavior: a systematic review and meta-analysis.

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Herd, Michael; Whittingham, Koa; Sanders, Matthew; Colditz, Paul; Boyd, Roslyn N

2014-01-01

The aim of this systematic review was to determine the efficacy of parenting interventions for parents of preterm infants to improve child behavior. Randomized controlled trials (RCTs) of parenting interventions for parents of preterm infants were included. Searchers were conducted of PubMed from 1951 to April 2013, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) from 1982 to April 2013, Scopus from 1966 to April 2013, PsycINFO from 1840 to April 2013, the Web of Science, and the Cochrane Library. Twelve RCTs were identified that assessed child behavior. Of these studies, only data from three were able to be pooled for meta-analysis: the Infant Health and Development Program (IHDP) at 3 years, the Mother-Infant Transaction Program (modified; MITP-M) at 5 years, and the Victorian Infant Brain Studies (VIBeS Plus) at 4 years. Outcome from this analysis revealed a small, but significant, effect on child behavior favoring the intervention (95% CI: 0.08-0.32; p = .001). There is evidence that preterm parenting interventions can improve child behavior. Streamlined interventions such as MITP-M and VIBeS Plus that have a strong focus on the mother-infant relationship may have greatest potential. © 2014 Michigan Association for Infant Mental Health.

Clinical exercise interventions in alcohol use disorders: a systematic review.

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Giesen, Esther S; Deimel, Hubertus; Bloch, Wilhelm

2015-05-01

The therapeutic impact of exercise interventions in psychiatric diseases such as depression, anxiety and schizophrenia has already been proven through several reviews whereas substance use disorders such as alcohol use disorders (AUD) have so far less frequently been a matter of investigation. Although several publications have summarized studies focusing on physical activities in substance use disorders, no systematic review exists summarizing the evidence of exercise interventions in AUD. A total of 14 studies using the Medline Database, CCMed, Cochrane Library and PsychINFO were identified and met the inclusion criteria. In order to evaluate the evidence, we used the evaluation system of the Oxford Centre for Evidence-Based Medicine (2011). Due to methodological flaws the overall evidence of the studies is rated level "3" but primarily findings confirm that exercise interventions as a complementary treatment component in AUD are feasible and safe. No adverse events were reported. This systematic review indicates that exercise may have beneficial effects on certain domains of physical functioning including VO2max, basal heart rate, physical activity level and strength. Inconsistent effects with a slight trend towards a positive effect on anxiety, mood management, craving, and drinking behavior have been shown and need to be verified. Results must be interpreted cautiously due to the numerous methodological flaws and the heterogeneity of the interventions and measures. However, according to preclinical studies several mechanisms of action are conceivable, especially as to alcohol-related outcomes and additionally seem to be promising. RCTs with high methodological quality are urgently needed in future research to establish evidence-based exercise recommendations for the treatment of AUD. Copyright © 2015 Elsevier Inc. All rights reserved.

Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital.

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Rowlands, Ceri; Rooshenas, Leila; Fairhurst, Katherine; Rees, Jonathan; Gamble, Carrol; Blazeby, Jane M

2018-02-02

To examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature. Studies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls; www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study. Of 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more 'real' RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent. There is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Annual Research Review: Digital health interventions for children and young people with mental health problems - a systematic and meta-review.

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Hollis, Chris; Falconer, Caroline J; Martin, Jennifer L; Whittington, Craig; Stockton, Sarah; Glazebrook, Cris; Davies, E Bethan

2017-04-01

Digital health interventions (DHIs), including computer-assisted therapy, smartphone apps and wearable technologies, are heralded as having enormous potential to improve uptake and accessibility, efficiency, clinical effectiveness and personalisation of mental health interventions. It is generally assumed that DHIs will be preferred by children and young people (CYP) given their ubiquitous digital activity. However, it remains uncertain whether: DHIs for CYP are clinically and cost-effective, CYP prefer DHIs to traditional services, DHIs widen access and how they should be evaluated and adopted by mental health services. This review evaluates the evidence-base for DHIs and considers the key research questions and approaches to evaluation and implementation. We conducted a meta-review of scoping, narrative, systematic or meta-analytical reviews investigating the effectiveness of DHIs for mental health problems in CYP. We also updated a systematic review of randomised controlled trials (RCTs) of DHIs for CYP published in the last 3 years. Twenty-one reviews were included in the meta-review. The findings provide some support for the clinical benefit of DHIs, particularly computerised cognitive behavioural therapy (cCBT), for depression and anxiety in adolescents and young adults. The systematic review identified 30 new RCTs evaluating DHIs for attention deficit/hyperactivity disorder (ADHD), autism, anxiety, depression, psychosis, eating disorders and PTSD. The benefits of DHIs in managing ADHD, autism, psychosis and eating disorders are uncertain, and evidence is lacking regarding the cost-effectiveness of DHIs. Key methodological limitations make it difficult to draw definitive conclusions from existing clinical trials of DHIs. Issues include variable uptake and engagement with DHIs, lack of an agreed typology/taxonomy for DHIs, small sample sizes, lack of blinded outcome assessment, combining different comparators, short-term follow-up and poor specification of

The Effectiveness of Mindfulness-Based Interventions on Maternal Perinatal Mental Health Outcomes: a Systematic Review.

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Shi, Zhenrong; MacBeth, Angus

2017-01-01

Presenting with common mental health difficulties, particularly depression and anxiety, there is also preliminary evidence that mindfulness-based interventions (MBIs) including mindfulness-based cognitive therapy (MBCT), mindfulness-based stress reduction (MBSR) and integrated mindfulness yoga practices may also be effective in reducing common mental health difficulties during pregnancy. We systematically reviewed and synthesized the current literature on the effectiveness of MBIs in reducing severity of perinatal anxiety and depression. Databases including PubMed, Cochrane Library, IndMED and PsychoInfo were searched for relevant studies. Manual searches were conducted in relevant articles and Google Scholar. Seventeen cohorts representing 18 studies were included. Pre-post effect sizes were reported for both treatment and control groups. Seven randomized controlled trials (RCTs), two non-randomized controlled trials and nine treatment evaluations were included. Maternal participation in an MBI was associated with reductions in perinatal anxiety of moderate to large magnitude. Results for the effect of MBIs on depression were less consistent, with pre-post treatment reductions of moderate magnitude, but no significant differences in depression scores when MBI was compared with a control group. There was some evidence that MBIs were associated with increased mindfulness. Risk of bias in studies was variable. Our review offers preliminary evidence for the effectiveness of MBIs in reducing perinatal anxiety, with more equivocal findings with regard to perinatal depressive symptoms. Further methodologically rigorous evaluation using RCTs and longer follow-up periods are recommended.

How to Measure the Intervention Process? An Assessment of Qualitative and Quantitative Approaches to Data Collection in the Process Evaluation of Organizational Interventions

OpenAIRE

Johan Simonsen Abildgaard; Per Øystein Saksvik; Karina Nielsen

2016-01-01

The evaluation of organizational interventions targeting employee health and wellbeing has been found to be a challenging task (Murta et al., 2007). The use of process evaluation, defined as the evaluation of “individual, collective or management perceptions and actions in implementing any intervention and their influence on the overall result of the intervention.” Nytrø et al. (2000) has served to increase focus on the evaluation of the specific intervention processes and not only the outcom...

Economic evaluation of targeted cancer interventions: critical review and recommendations.

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Elkin, Elena B; Marshall, Deborah A; Kulin, Nathalie A; Ferrusi, Ilia L; Hassett, Michael J; Ladabaum, Uri; Phillips, Kathryn A

2011-10-01

Scientific advances have improved our ability to target cancer interventions to individuals who will benefit most and spare the risks and costs to those who will derive little benefit or even be harmed. Several approaches are currently used for targeting interventions for cancer risk reduction, screening, and treatment, including risk prediction algorithms for identifying high-risk subgroups and diagnostic tests for tumor markers and germline genetic mutations. Economic evaluation can inform decisions about the use of targeted interventions, which may be more costly than traditional strategies. However, assessing the impact of a targeted intervention on costs and health outcomes requires explicit consideration of the method of targeting. In this study, we describe the importance of this principle by reviewing published cost-effectiveness analyses of targeted interventions in breast cancer. Few studies we identified explicitly evaluated the relationships among the method of targeting, the accuracy of the targeting test, and outcomes of the targeted intervention. Those that did found that characteristics of targeting tests had a substantial impact on outcomes. We posit that the method of targeting and the outcomes of a targeted intervention are inextricably linked and recommend that cost-effectiveness analyses of targeted interventions explicitly consider costs and outcomes of the method of targeting.

Collaboratively Evaluating Cooperative Extension Educational Interventions.

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Webb, Debb; Murphy, Dennis J.; Kiernan, Nancy Ellen

2001-01-01

Three intervention models to reduce hazards and risks of farm work were tested: self-audit (n=73), youth safety and health program (n=64), and a community coalition for safety and health (n=17). Despite some difficulties, university researchers and agents did accomplish the primary goal: scientific evaluation of models of safety education. (SK)

Clinical effectiveness and cost-effectiveness of interventions for the treatment of anogenital warts: systematic review and economic evaluation.

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Thurgar, Elizabeth; Barton, Samantha; Karner, Charlotta; Edwards, Steven J

2016-03-01

Typically occurring on the external genitalia, anogenital warts (AGWs) are benign epithelial skin lesions caused by human papillomavirus infection. AGWs are usually painless but can be unsightly and physically uncomfortable, and affected people might experience psychological distress. The evidence base on the clinical effectiveness and cost-effectiveness of treatments for AGWs is limited. To systematically review the evidence on the clinical effectiveness of medical and surgical treatments for AGWs and to develop an economic model to estimate the cost-effectiveness of the treatments. Electronic databases (MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library databases and Web of Science) were searched from inception (or January 2000 for Web of Science) to September 2014. Bibliographies of relevant systematic reviews were hand-searched to identify potentially relevant studies. The World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov were searched for ongoing and planned studies. A systematic review of the clinical effectiveness literature was carried out according to standard methods and a mixed-treatment comparison (MTC) undertaken. The model implemented for each outcome was that with the lowest deviance information criterion. A de novo economic model was developed to assess cost-effectiveness from the perspective of the UK NHS. The model structure was informed through a systematic review of the economic literature and in consultation with clinical experts. Effectiveness data were obtained from the MTC. Costs were obtained from the literature and standard UK sources. Of 4232 titles and abstracts screened for inclusion in the review of clinical effectiveness, 60 randomised controlled trials (RCTs) evaluating 19 interventions were included. Analysis by MTC indicated that ablative techniques were typically more effective than topical interventions at completely clearing AGWs at the end of

Are interventions for low-income groups effective in changing healthy eating, physical activity and smoking behaviours? A systematic review and meta-analysis.

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Bull, Eleanor R; Dombrowski, Stephan U; McCleary, Nicola; Johnston, Marie

2014-11-28

To conduct a systematic review and meta-analysis examining the effectiveness of behavioural interventions targeting diet, physical activity or smoking in low-income adults. Systematic review with random effects meta-analyses. Studies before 2006 were identified from a previously published systematic review (searching 1995-2006) with similar but broader inclusion criteria (including non-randomised controlled trials (RCTs)). Studies from 2006 to 2014 were identified from eight electronic databases using a similar search strategy. MEDLINE, EMBASE, PsycINFO, ASSIA, CINAHL, Cochrane Controlled Trials, Cochrane Systematic Review and DARE. RCTs and cluster RCTs published from 1995 to 2014; interventions targeting dietary, physical activity and smoking; low-income adults; reporting of behavioural outcomes. Dietary, physical activity and smoking cessation behaviours. 35 studies containing 45 interventions with 17,000 participants met inclusion criteria. At postintervention, effects were positive but small for diet (standardised mean difference (SMD) 0.22, 95% CI 0.14 to 0.29), physical activity (SMD 0.21, 95% CI 0.06 to 0.36) and smoking (relative risk (RR) of 1.59, 95% CI 1.34 to 1.89). Studies reporting follow-up results suggested that effects were maintained over time for diet (SMD 0.16, 95% CI 0.08 to 0.25) but not physical activity (SMD 0.17, 95% CI -0.02 to 0.37) or smoking (RR 1.11, 95% CI 0.93 to 1.34). Behaviour change interventions for low-income groups had small positive effects on healthy eating, physical activity and smoking. Further work is needed to improve the effectiveness of behaviour change interventions for deprived populations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Health-promoting vending machines: evaluation of a pediatric hospital intervention.

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Van Hulst, Andraea; Barnett, Tracie A; Déry, Véronique; Côté, Geneviève; Colin, Christine

2013-01-01

Taking advantage of a natural experiment made possible by the placement of health-promoting vending machines (HPVMs), we evaluated the impact of the intervention on consumers' attitudes toward and practices with vending machines in a pediatric hospital. Vending machines offering healthy snacks, meals, and beverages were developed to replace four vending machines offering the usual high-energy, low-nutrition fare. A pre- and post-intervention evaluation design was used; data were collected through exit surveys and six-week follow-up telephone surveys among potential vending machine users before (n=293) and after (n=226) placement of HPVMs. Chi-2 statistics were used to compare pre- and post-intervention participants' responses. More than 90% of pre- and post-intervention participants were satisfied with their purchase. Post-intervention participants were more likely to state that nutritional content and appropriateness of portion size were elements that influenced their purchase. Overall, post-intervention participants were more likely than pre-intervention participants to perceive as healthy the options offered by the hospital vending machines. Thirty-three percent of post-intervention participants recalled two or more sources of information integrated in the HPVM concept. No differences were found between pre- and post-intervention participants' readiness to adopt healthy diets. While the HPVM project had challenges as well as strengths, vending machines offering healthy snacks are feasible in hospital settings.

The Effectiveness of Pharmacological and Non-Pharmacological Interventions for Improving Glycaemic Control in Adults with Severe Mental Illness: A Systematic Review and Meta-Analysis

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Taylor, Johanna; Stubbs, Brendon; Hewitt, Catherine; Ajjan, Ramzi A.; Gilbody, Simon; Holt, Richard I. G.; Hughes, Tom; Kellar, Ian; Mahmoodi, Neda; Smith, Robert D.; Wright, Judy M.; Siddiqi, Najma

2017-01-01

People with severe mental illness (SMI) have reduced life expectancy compared with the general population, which can be explained partly by their increased risk of diabetes. We conducted a meta-analysis to determine the clinical effectiveness of pharmacological and non-pharmacological interventions for improving glycaemic control in people with SMI (PROSPERO registration: CRD42015015558). A systematic literature search was performed on 30/10/2015 to identify randomised controlled trials (RCTs) in adults with SMI, with or without a diagnosis of diabetes that measured fasting blood glucose or glycated haemoglobin (HbA1c). Screening and data extraction were carried out independently by two reviewers. We used random effects meta-analysis to estimate effectiveness, and subgroup analysis and univariate meta-regression to explore heterogeneity. The Cochrane Collaboration’s tool was used to assess risk of bias. We found 54 eligible RCTs in 4,392 adults (40 pharmacological, 13 behavioural, one mixed intervention). Data for meta-analysis were available from 48 RCTs (n = 4052). Both pharmacological (mean difference (MD), -0.11mmol/L; 95% confidence interval (CI), [-0.19, -0.02], p = 0.02, n = 2536) and behavioural interventions (MD, -0.28mmol//L; 95% CI, [-0.43, -0.12], pfasting glucose, but not HbA1c (pharmacological MD, -0.03%; 95% CI, [-0.12, 0.06], p = 0.52, n = 1515; behavioural MD, 0.18%; 95% CI, [-0.07, 0.42], p = 0.16, n = 140) compared with usual care or placebo. In subgroup analysis of pharmacological interventions, metformin and antipsychotic switching strategies improved HbA1c. Behavioural interventions of longer duration and those including repeated physical activity had greater effects on fasting glucose than those without these characteristics. Baseline levels of fasting glucose explained some of the heterogeneity in behavioural interventions but not in pharmacological interventions. Although the strength of the evidence is limited by inadequate trial design

Parent-Mediated Intervention Training Delivered Remotely for Children With Autism Spectrum Disorder Living Outside of Urban Areas: Systematic Review.

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Parsons, Dave; Cordier, Reinie; Vaz, Sharmila; Lee, Hoe C

2017-08-14

Parent training programs for families living outside of urban areas can be used to improve the social behavior and communication skills in children with autism spectrum disorder (ASD). However, no review has been conducted to investigate these programs. The aim of this study was to (1) systematically review the existing evidence presented by studies on parent-mediated intervention training, delivered remotely for parents having children with ASD and living outside of urban areas; (2) provide an overview of current parent training interventions used with this population; (3) and provide an overview of the method of delivery of the parent training interventions used with this population. Guided by the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement, we conducted a comprehensive review across 5 electronic databases (CINAHL, Embase, ERIC, PsycINFO, and Pubmed) on July 4, 2016, searching for studies investigating parent-mediated intervention training for families living outside of urban centers who have a child diagnosed with ASD. Two independent researchers reviewed the articles for inclusion, and assessment of methodological quality was based on the Kmet appraisal checklist. Seven studies met the eligibility criteria, including 2 prepost cohort studies, 3 multiple baseline studies, and 2 randomized controlled trials (RCTs). Interventions included mostly self-guided websites: with and without therapist assistance (n=6), with training videos, written training manuals, and videoconferencing. Post intervention, studies reported significant improvements (P<.05) in parent knowledge (n=4), parent intervention fidelity (n=6), and improvements in children's social behavior and communication skills (n=3). A high risk of bias existed within all of the studies because of a range of factors including small sample sizes, limited use of standardized outcome measures, and a lack of control groups to negate confounding factors. There is

Effectiveness of IT-based diabetes management interventions: a review of the literature.

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Costa, Beth M; Fitzgerald, Kristine J; Jones, Kay M; Dunning Am, Trisha

2009-11-17

Information technology (IT) is increasingly being used in general practice to manage health care including type 2 diabetes. However, there is conflicting evidence about whether IT improves diabetes outcomes. This review of the literature about IT-based diabetes management interventions explores whether methodological issues such as sample characteristics, outcome measures, and mechanisms causing change in the outcome measures could explain some of the inconsistent findings evident in IT-based diabetes management studies. Databases were searched using terms related to IT and diabetes management. Articles eligible for review evaluated an IT-based diabetes management intervention in general practice and were published between 1999 and 2009 inclusive in English. Studies that did not include outcome measures were excluded. Four hundred and twenty-five articles were identified, sixteen met the inclusion criteria: eleven GP focussed and five patient focused interventions were evaluated. Nine were RCTs, five non-randomised control trials, and two single-sample before and after designs. Important sample characteristics such as diabetes type, familiarity with IT, and baseline diabetes knowledge were not addressed in any of the studies reviewed. All studies used HbA1c as a primary outcome measure, and nine reported a significant improvement in mean HbA1c over the study period; only two studies reported the HbA1c assay method. Five studies measured diabetes medications and two measured psychological outcomes. Patient lifestyle variables were not included in any of the studies reviewed. IT was the intervention method considered to effect changes in the outcome measures. Only two studies mentioned alternative possible causal mechanisms. Several limitations could affect the outcomes of IT-based diabetes management interventions to an unknown degree. These limitations make it difficult to attribute changes solely to such interventions.

Evaluating Public Health Interventions: 1. Examples, Definitions, and a Personal Note.

Science.gov (United States)

Spiegelman, Donna

2016-01-01

In the first contribution to a new section in AJPH that will address critical methodological issues in evaluations of public health interventions, I will discuss topics in study design and analysis, covering the most innovative emerging methodologies and providing an overview of best practices. The methods considered are motivated by public health evaluations, both domestic and global. In this first contribution, I also define implementation science, program evaluation, impact evaluation, and cost-effectiveness research, disciplines that have tremendous methodological and substantive overlap with evaluation of public health interventions--the focus of this section.

Process evaluation of a worksite social and physical environmental intervention

NARCIS (Netherlands)

Coffeng, J.K.; Hendriksen, I.J.M.; Mechelen, W. van; Boot, C.R.L.

2013-01-01

OBJECTIVE:: To evaluate the process of implementation of a social and physical environmental intervention and to explore differences regarding this process between both interventions. METHODS:: Context, recruitment, dose delivered, fidelity, reach, dose received, satisfaction, and implementation

Influence of exercise intervention on gestational diabetes mellitus: a systematic review and meta-analysis.

Science.gov (United States)

Zheng, J; Wang, H; Ren, M

2017-10-01

Exercise intervention might be a promising approach to prevent gestational diabetes mellitus. However, the results remained controversial. We conducted a systematic review and meta-analysis to explore the effect of exercise intervention on gestational diabetes mellitus. PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases were systematically searched. Randomized controlled trials (RCTs) assessing the effect of exercise intervention on gestational diabetes mellitus were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcome was the incidence of gestational diabetes mellitus, preterm birth, and gestational age at birth. Meta-analysis was performed using random-effect model. Five RCTs involving 1872 patients were included in the meta-analysis. Overall, compared with control intervention, exercise intervention was found to significantly reduce the risk of gestational diabetes mellitus (std. mean difference 0.62; 95% CI 0.43-0.89; P = 0.01), but demonstrated no influence on preterm birth (OR 0.93; 95% CI 0.44-1.99; P = 0.86), gestational age at birth (std. mean difference -0.03; 95% CI -0.12 to 0.07; P = 0.60), glucose 2-h post-OGTT (std. mean difference -1.02; 95% CI -2.75 to 0.71; P = 0.25), birth weight (std. mean difference -0.10; 95% CI -0.25 to 0.04; P = 0.16), Apgar score less than 7 (OR 0.78; 95% CI 0.21-2.91; P = 0.71), and preeclampsia (OR 1.05; 95% CI 0.53-2.07; P = 0.88). Compared to control intervention, exercise intervention was found to significantly reduce the incidence of gestational diabetes mellitus, but had no significant influence on preterm birth, gestational age at birth, glucose 2-h post-OGTT, birth weight, Apgar score less than 7, and preeclampsia.

Evaluation of radiation risk and work practices during cerebral interventions

Energy Technology Data Exchange (ETDEWEB)

Livingstone, Roshan S; Raghuram, L; Korah, Ipeson P; Raj, D Victor [Department of Radiodiagnosis, Christian Medical College, Vellore 632004 (India)

2003-09-01

This study was intended to evaluate radiation risk to patients during cerebral interventions and the contribution to this risk from work practices. Thirty nine patients undergoing cerebral interventions in a digital subtraction angiography suite were included in this study. Patients who underwent cerebral interventions were categorised into two groups according to the number of cerebral interventions performed on them, and their effective doses were calculated. The effective dose for patients undergoing a single cerebral intervention (group A) varied from 1.55 to 15.9 mSv and for multiple cerebral interventions (group B) varied from 16.52 to 43.52 mSv. Two patients who underwent multiple cerebral interventions (group B) had alopecia of the irradiated scalp.

Selection and Evaluation of Media for Behavioral Health Interventions Employing Critical Media Analysis.

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Wilson, Patrick A; Cherenack, Emily M; Jadwin-Cakmak, Laura; Harper, Gary W

2018-01-01

Although a growing number of psychosocial health promotion interventions use the critical analysis of media to facilitate behavior change, no specific guidelines exist to assist researchers and practitioners in the selection and evaluation of culturally relevant media stimuli for intervention development. Mobilizing Our Voices for Empowerment is a critical consciousness-based health enhancement intervention for HIV-positive Black young gay/bisexual men that employs the critical analysis of popular media. In the process of developing and testing this intervention, feedback on media stimuli was collected from youth advisory board members (n = 8), focus group participants (n = 19), intervention participants (n = 40), and intervention facilitators (n = 6). A thematic analysis of qualitative data resulted in the identification of four key attributes of media stimuli and participants' responses to media stimuli that are important to consider when selecting and evaluating media stimuli for use in behavioral health interventions employing the critical analysis of media: comprehension, relevance, emotionality, and action. These four attributes are defined and presented as a framework for evaluating media, and adaptable tools are provided based on this framework to guide researchers and practitioners in the selection and evaluation of media for similar interventions.

The use of the Chronicle Workshop as a method for evaluating participatory interventions

DEFF Research Database (Denmark)

Poulsen, Signe; Ipsen, Christine; Gish, Liv

2014-01-01

In the organizational intervention literature it has been stated that interventions needs to be evaluated both with respect to outcome and process. In an organizational intervention program we used the Chronicle Workshop in order to see if it was applicable as a process evaluation method. Surveys...

Improving utility conservation programs: outcomes, interventions, and evaluations

Energy Technology Data Exchange (ETDEWEB)

Condelli, L; Archer, D; Aronson, E; Curbow, B; McLeod, B; Pettigrew, T F; White, L T; Yates, S

1984-06-01

Four major California utility companies have active energy conservation programs mandated by the State's Public Utilities Commission (CPUC). These companies evaluate their programs and send reports of the evaluations to the CPUC. A review of 213 of these reports revealed a marketing research approach toward promoting conservation. Advertising and informational campaigns characterize most programs, and attitudes and self-reported behavior were the major outcome measures. This approach is shown to be ineffective. Suggestions for improvement include: (1) the use of actual energy consumption as the primary outcome measure in evaluating conservation programs; (2) the abandonment of conventional advertising, and the use of it only for the promotion of ''hard'' interventions; (3) increased use of social diffusion methods to disseminate information; (4) the design of more effective educational material by incorporating cognitive social psychological principles; and (5) the utilization of ''hard'' interventions that have a direct, verifiable link to conservation.

Workplace-Based Interventions for Neck Pain in Office Workers

DEFF Research Database (Denmark)

Chen, Xiaoqi; Coombes, Brooke K; Sjøgaard, Gisela

2018-01-01

-quality evidence. Limitations: Data could not be obtained from some studies for meta-analysis and assessment of risk of bias. Reporting bias might have been present because only studies in the English language were included. Conclusions: Workplace-based strengthening exercises were effective in reducing neck pain....... Data Sources: MEDLINE, PEDro, CINAHL, and CENTRAL were searched for trials published since inception and before May 31, 2016. Study Selection: Randomized controlled trials (RCTs) were considered when they met the following criteria: population consisted of office workers, intervention(s) was performed...... at the workplace, outcome measures included neck and/or neck/shoulder pain intensity and incidence/prevalence, and comparator groups included no/other intervention. Data Extraction: Data were extracted by 1 reviewer using predefined data fields and checked by a second reviewer. Risk of bias was assessed by 2...

Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

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Leamy, Mary; Clarke, Eleanor; Le Boutillier, Clair; Bird, Victoria; Janosik, Monika; Sabas, Kai; Riley, Genevieve; Williams, Julie; Slade, Mike

2014-01-01

To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. Process evaluation nested within a cluster randomised controlled trial (RCT). 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. 14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention. The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research

Brain Reorganization following Intervention in Children with Congenital Hemiplegia: A Systematic Review

Directory of Open Access Journals (Sweden)

E. Inguaggiato

2013-01-01

Full Text Available Noninvasive rehabilitation strategies for children with unilateral cerebral palsy are routinely used to improve hand motor function, activity, and participation. Nevertheless, the studies exploring their effects on brain structure and function are very scarce. Recently, structural neuroplasticity was demonstrated in adult poststroke patients, in response to neurorehabilitation. Our purpose is to review current evidence on the effects of noninvasive intervention strategies on brain structure or function, in children with unilateral cerebral palsy. The main literature databases were searched up to October 2013. We included studies where the effects of upper limb training were evaluated at neurofunctional and/or neurostructural levels. Only seven studies met our selection criteria; selected studies were case series, six using the intervention of the constraint-induced movement therapy (CIMT and one used virtual reality therapy (VR. CIMT and VR seem to produce measurable neuroplastic changes in sensorimotor cortex associated with enhancement of motor skills in the affected limb. However, the level of evidence is limited, due to methodological weaknesses and small sample sizes of available studies. Well-designed and larger experimental studies, in particular RCTs, are needed to strengthen the generalizability of the findings and to better understand the mechanism of intervention-related brain plasticity in children with brain injury.

A realist synthesis of randomised control trials involving use of community health workers for delivering child health interventions in low and middle income countries

Directory of Open Access Journals (Sweden)

Dal Poz Mario

2010-10-01

Full Text Available Abstract Background A key constraint to saturating coverage of interventions for reducing the burden of childhood illnesses in Low and Middle Income Countries (LMIC is the lack of human resources. Community health workers (CHW are potentially important actors in bridging this gap. Evidence exists on effectiveness of CHW in management of some childhood illnesses (IMCI. However, we need to know how and when this comes to be. We examine evidence from randomized control trials (RCT on CHW interventions in IMCI in LMIC from a realist perspective with the aim to see if they can yield insight into the working of the interventions, when examined from a different perspective. Methods The realist approach involves educing the mechanisms through which an intervention produced an outcome in a particular context. 'Mechanisms' are reactions, triggered by the interaction of the intervention and a certain context, which lead to change. These are often only implicit and are actually hypothesized by the reviewer. This review is limited to unravelling these from the RCTs; it is thus a hypothesis generating exercise. Results Interventions to improve CHW performance included 'Skills based training of CHW', 'Supervision and referral support from public health services', 'Positioning of CHW in the community'. When interventions were applied in context of CHW programs embedded in local health services, with beneficiaries who valued services and had unmet needs, the interventions worked if following mechanisms were triggered: anticipation of being valued by the community; perception of improvement in social status; sense of relatedness with beneficiaries and public services; increase in self esteem; sense of self efficacy and enactive mastery of tasks; sense of credibility, legitimacy and assurance that there was a system for back-up support. Studies also showed that if context differed, even with similar interventions, negative mechanisms could be triggered

Process variables in organizational stress management intervention evaluation research: a systematic review.

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Havermans, Bo M; Schlevis, Roosmarijn Mc; Boot, Cécile Rl; Brouwers, Evelien Pm; Anema, Johannes; van der Beek, Allard J

2016-09-01

This systematic review aimed to explore which process variables are used in stress management intervention (SMI) evaluation research. A systematic review was conducted using seven electronic databases. Studies were included if they reported on an SMI aimed at primary or secondary stress prevention, were directed at paid employees, and reported process data. Two independent researchers checked all records and selected the articles for inclusion. Nielsen and Randall's model for process evaluation was used to cluster the process variables. The three main clusters were context, intervention, and mental models. In the 44 articles included, 47 process variables were found, clustered into three main categories: context (two variables), intervention (31 variables), and mental models (14 variables). Half of the articles contained no reference to process evaluation literature. The collection of process evaluation data mostly took place after the intervention and at the level of the employee. The findings suggest that there is great heterogeneity in methods and process variables used in process evaluations of SMI. This, together with the lack of use of a standardized framework for evaluation, hinders the advancement of process evaluation theory development.

Sustainability of knowledge translation interventions in healthcare decision-making: a scoping review.

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Tricco, Andrea C; Ashoor, Huda M; Cardoso, Roberta; MacDonald, Heather; Cogo, Elise; Kastner, Monika; Perrier, Laure; McKibbon, Ann; Grimshaw, Jeremy M; Straus, Sharon E

2016-04-21

Knowledge translation (KT, also known as research utilization, and sometimes referring to implementation science) is a dynamic and iterative process that includes the synthesis, dissemination, exchange, and ethically sound application of knowledge to improve health. A KT intervention is one which facilitates the uptake of research. The long-term sustainability of KT interventions is unclear. We aimed to characterize KT interventions to manage chronic diseases that have been used for healthcare outcomes beyond 1 year or beyond the termination of initial grant funding. We conducted a scoping review by searching MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Campbell from inception until February 2013. We included experimental, quasi-experimental, and observational studies providing information on the sustainability of KT interventions for managing chronic diseases in adults and focusing on end-users including patients, clinicians, public health officials, health service managers, and policy-makers. Articles were screened and abstracted by two reviewers, independently. The data were charted and results described narratively. We included 62 studies reported in 103 publications (total 260,688 patients) plus 41 companion reports after screening 12,328 titles and abstracts and 464 full-text articles. More than half of the studies were randomized controlled trials (RCTs). The duration of the KT intervention ranged from 61 to 522 weeks. Nine chronic conditions were examined across the studies, such as diabetes (34 %), cardiovascular disease (28 %), and hypertension (16 %). Thirteen KT interventions were reported across the studies. Patient education was the most commonly examined (20 %), followed by self-management (17 %). Most studies (61 %) focused on patient-level outcomes (e.g. disease severity), while 31 % included system-level outcomes (e.g. number of eye examinations

An Evaluation Framework for Obesity Prevention Policy Interventions

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Sommers, Janice; Vu, Maihan; Jernigan, Jan; Payne, Gayle; Thompson, Diane; Heiser, Claire; Farris, Rosanne; Ammerman, Alice

2012-01-01

As the emphasis on preventing obesity has grown, so have calls for interventions that extend beyond individual behaviors and address changes in environments and policies. Despite the need for policy action, little is known about policy approaches that are most effective at preventing obesity. The Centers for Disease Control and Prevention (CDC) and others are funding the implementation and evaluation of new obesity prevention policies, presenting a distinct opportunity to learn from these practice-based initiatives and build the body of evidence-based approaches. However, contributions from this policy activity are limited by the incomplete and inconsistent evaluation data collected on policy processes and outcomes. We present a framework developed by the CDC-funded Center of Excellence for Training and Research Translation that public health practitioners can use to evaluate policy interventions and identify the practice-based evidence needed to fill the gaps in effective policy approaches to obesity prevention. PMID:22742594

Commentary: Randomized controlled trials in autism spectrum disorder: state of the field and challenges for the future.

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Simonoff, Emily

2018-04-01

This issue of the Journal includes two articles summarizing the evidence from clinical trials aimed at improving symptoms of autism. French and Kennedy (Journal of Child Psychology and Psychiatry, 2018, xx, xxxx) systematically review randomized controlled trials (RCTs) aimed at an "early intervention" and focus on trials including children with or at risk of autism under age 6 years. Although no type of intervention were excluded from their review, none of the included 48 RCTs employed pharmacological modalities and the overwhelming majority tested psychological/behavioural interventions aimed at modifying aspects of observed behaviours that are abnormal in children with autism. Using the standard Cochrane tool for evaluating risk of bias, French and Kennedy conclude that many RCTs are of low quality, which throws into question the reliance that should be placed on the findings. © 2018 Association for Child and Adolescent Mental Health.

Economic evaluation of interventions designed to reduce Clostridium difficile infection.

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Brain, David; Yakob, Laith; Barnett, Adrian; Riley, Thomas; Clements, Archie; Halton, Kate; Graves, Nicholas

2018-01-01

Healthcare decision-makers are increasingly expected to balance increasing demand for health services with a finite budget. The role of economic evaluation in healthcare is increasing and this research provides decision-makers with new information about the management of Clostridium difficile infection, from an economic perspective. A model-based economic evaluation was undertaken to identify the most cost-effective healthcare intervention relating to the reduction of Clostridium difficile transmission. Efficacy evidence was synthesised from the literature and was used to inform the effectiveness of both bundled approaches and stand-alone interventions, where appropriate intervention combinations were coupled together. Changes in health outcomes were estimated by combining information about intervention effectiveness and its subsequent impact on quality of life. A bundled approach of improving hand hygiene and environmental cleaning produces the best combination of increased health benefits and cost-savings. It has the highest mean net monetary benefit when compared to all other interventions. This intervention remains the optimal decision under different clinical circumstances, such as when mortality rate and patient length of stay are increased. Bundled interventions offered the best opportunity for health improvements. These findings provide healthcare decision-makers with novel information about the allocation of scarce resources relating to Clostridium difficile. If investments are not made in interventions that clearly yield gains in health outcomes, the allocation and use of scarce healthcare resources is inappropriate and improvements in health outcomes will be forgone.

Economic evaluation of interventions designed to reduce Clostridium difficile infection.

Directory of Open Access Journals (Sweden)

David Brain

Full Text Available Healthcare decision-makers are increasingly expected to balance increasing demand for health services with a finite budget. The role of economic evaluation in healthcare is increasing and this research provides decision-makers with new information about the management of Clostridium difficile infection, from an economic perspective.A model-based economic evaluation was undertaken to identify the most cost-effective healthcare intervention relating to the reduction of Clostridium difficile transmission. Efficacy evidence was synthesised from the literature and was used to inform the effectiveness of both bundled approaches and stand-alone interventions, where appropriate intervention combinations were coupled together. Changes in health outcomes were estimated by combining information about intervention effectiveness and its subsequent impact on quality of life.A bundled approach of improving hand hygiene and environmental cleaning produces the best combination of increased health benefits and cost-savings. It has the highest mean net monetary benefit when compared to all other interventions. This intervention remains the optimal decision under different clinical circumstances, such as when mortality rate and patient length of stay are increased. Bundled interventions offered the best opportunity for health improvements.These findings provide healthcare decision-makers with novel information about the allocation of scarce resources relating to Clostridium difficile. If investments are not made in interventions that clearly yield gains in health outcomes, the allocation and use of scarce healthcare resources is inappropriate and improvements in health outcomes will be forgone.

Workplace physical activity interventions: a systematic review.

Science.gov (United States)

To, Quyen G; Chen, Ted T L; Magnussen, Costan G; To, Kien G

2013-01-01

To assess the effectiveness of workplace interventions in improving physical activity. EBSCO research database (and all subdatabases). Articles were published from 2000 to 2010 in English, had appropriate designs, and measured employees' physical activity, energy consumption, and/or body mass index (BMI) as primary outcomes. Articles that did not meet the inclusion criteria were excluded. Data extracted included study design, study population, duration, intervention activities, outcomes, and results. Data were synthesized into one table. Results of each relevant outcome including p values were combined. Twelve (60%) of 20 selected interventions reported an improvement in physical activity level, steps, or BMI, and there was one slowed step reduction in the intervention group. Among these, 10 were less than 6 months in duration; 9 used pedometers; 6 applied Internet-based approaches; and 5 included activities targeting social and environmental levels. Seven of 8 interventions with pre-posttest and quasi-experimental controlled design showed improvement on at least one outcome. However, 7 of 12 randomized controlled trials (RCTs) did not prove effective in any outcome. Interventions that had less rigorous research designs, used pedometers, applied Internet-based approaches, and included activities at social and environmental levels were more likely to report being effective than those without these characteristics.

Enhancing adherence in trials promoting change in diet and physical activity in individuals with a diagnosis of colorectal adenoma; a systematic review of behavioural intervention approaches.

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McCahon, Deborah; Daley, Amanda J; Jones, Janet; Haslop, Richard; Shajpal, Arjun; Taylor, Aliki; Wilson, Sue; Dowswell, George

2015-07-07

Little is known about colorectal adenoma patients' ability to adhere to behavioural interventions promoting a change in diet and physical activity. This review aimed to examine health behaviour intervention programmes promoting change in diet and/or physical activity in adenoma patients and characterise interventions to which this patient group are most likely to adhere. Searches of eight databases were restricted to English language publications 2000-2014. Reference lists of relevant articles were also reviewed. All randomised controlled trials (RCTs) of diet and physical activity interventions in colorectal adenoma patients were included. Eligibility and quality were assessed and data were extracted by two reviewers. Data extraction comprised type, intensity, provider, mode and location of delivery of the intervention and data to enable calculation of four adherence outcomes. Data were subject to narrative analysis. Five RCTs with a total of 1932 participants met the inclusion criteria. Adherence to the goals of the intervention ranged from 18 to 86 % for diet and 13 to 47 % for physical activity. Diet interventions achieving ≥ 50 % adherence to the goals of the intervention were clinic based, grounded in cognitive theory, delivered one to one and encouraged social support. The findings of this review indicate that behavioural interventions can encourage colorectal adenoma patients to improve their diet. This review was not however able to clearly characterise effective interventions promoting increased physical activity in this patient group. Further research is required to establish effective interventions to promote adherence to physical activity in this population.

Using computer, mobile and wearable technology enhanced interventions to reduce sedentary behaviour: a systematic review and meta-analysis.

Science.gov (United States)

Stephenson, Aoife; McDonough, Suzanne M; Murphy, Marie H; Nugent, Chris D; Mair, Jacqueline L

2017-08-11

High levels of sedentary behaviour (SB) are associated with negative health consequences. Technology enhanced solutions such as mobile applications, activity monitors, prompting software, texts, emails and websites are being harnessed to reduce SB. The aim of this paper is to evaluate the effectiveness of such technology enhanced interventions aimed at reducing SB in healthy adults and to examine the behaviour change techniques (BCTs) used. Five electronic databases were searched to identify randomised-controlled trials (RCTs), published up to June 2016. Interventions using computer, mobile or wearable technologies to facilitate a reduction in SB, using a measure of sedentary time as an outcome, were eligible for inclusion. Risk of bias was assessed using the Cochrane Collaboration's tool and interventions were coded using the BCT Taxonomy (v1). Meta-analysis of 15/17 RCTs suggested that computer, mobile and wearable technology tools resulted in a mean reduction of -41.28 min per day (min/day) of sitting time (95% CI -60.99, -21.58, I2 = 77%, n = 1402), in favour of the intervention group at end point follow-up. The pooled effects showed mean reductions at short (≤ 3 months), medium (>3 to 6 months), and long-term follow-up (>6 months) of -42.42 min/day, -37.23 min/day and -1.65 min/day, respectively. Overall, 16/17 studies were deemed as having a high or unclear risk of bias, and 1/17 was judged to be at a low risk of bias. A total of 46 BCTs (14 unique) were coded for the computer, mobile and wearable components of the interventions. The most frequently coded were "prompts and cues", "self-monitoring of behaviour", "social support (unspecified)" and "goal setting (behaviour)". Interventions using computer, mobile and wearable technologies can be effective in reducing SB. Effectiveness appeared most prominent in the short-term and lessened over time. A range of BCTs have been implemented in these interventions. Future studies need to improve reporting

A systematic review and meta-analysis of interventions for weight management using text messaging.

Science.gov (United States)

Siopis, G; Chey, T; Allman-Farinelli, M

2015-02-01

Obesity prevalence continues to increase worldwide, with significant associated chronic disease and health cost implications. Among more recent innovations in health service provision is the use of text messaging for health behaviour change interventions including weight management. This review investigates the efficacy of weight management programmes incorporating text messaging. Medical and scientific databases were searched from January 1993 to October 2013. Eligibility criteria included randomised controlled trials (RCTs), pseudoRCTs and before and after studies of weight management, among healthy children and adults, that used text messaging and included a nutrition component. Data extraction and quality assessment followed guidelines from PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) and the Evidence Analysis Manual of the American Academy of Nutrition and Dietetics. From 512 manuscripts retrieved, 14 met the inclusion criteria (five manuscripts in children and nine in adults). Duration of interventions ranged from 1 to 24 months. Frequency of text messaging was from daily to fortnightly. Six studies in adults were included in a meta-analysis with mean body weight change as the primary outcome. The weighted mean change in body weight in intervention participants was -2.56 kg (95% confidence interval = -3.46 to -1.65) and in controls -0.37 kg (95% confidence interval = -1.22 to 0.48). The small body of evidence indicates that text messaging interventions can promote weight loss. However, lack of long-term results indicate that further efficacy studies are required. Future investigations should elucidate the determinants, such as intervention duration, text message frequency and level of interactivity that maximise the success and cost effectiveness of the delivery medium. © 2014 The British Dietetic Association Ltd.

Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs.

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Steuri, Ruedi; Sattelmayer, Martin; Elsig, Simone; Kolly, Chloé; Tal, Amir; Taeymans, Jan; Hilfiker, Roger

2017-09-01

To investigate the effectiveness of conservative interventions for pain, function and range of motion in adults with shoulder impingement. Systematic review and meta-analysis of randomised trials. Medline, CENTRAL, CINAHL, Embase and PEDro were searched from inception to January 2017. Randomised controlled trials including participants with shoulder impingement and evaluating at least one conservative intervention against sham or other treatments. For pain, exercise was superior to non-exercise control interventions (standardised mean difference (SMD) -0.94, 95% CI -1.69 to -0.19). Specific exercises were superior to generic exercises (SMD -0.65, 95% CI -0.99 to -0.32). Corticosteroid injections were superior to no treatment (SMD -0.65, 95% CI -1.04 to -0.26), and ultrasound guided injections were superior to non-guided injections (SMD -0.51, 95% CI -0.89 to -0.13). Nonsteroidal anti-inflammatory drugs (NSAIDS) had a small to moderate SMD of -0.29 (95% CI -0.53 to -0.05) compared with placebo. Manual therapy was superior to placebo (SMD -0.35, 95% CI -0.69 to -0.01). When combined with exercise, manual therapy was superior to exercise alone, but only at the shortest follow-up (SMD -0.32, 95% CI -0.62 to -0.01). Laser was superior to sham laser (SMD -0.88, 95% CI -1.48 to -0.27). Extracorporeal shockwave therapy (ECSWT) was superior to sham (-0.39, 95% CI -0.78 to -0.01) and tape was superior to sham (-0.64, 95% CI -1.16 to -0.12), with small to moderate SMDs. Although there was only very low quality evidence, exercise should be considered for patients with shoulder impingement symptoms and tape, ECSWT, laser or manual therapy might be added. NSAIDS and corticosteroids are superior to placebo, but it is unclear how these treatments compare to exercise. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Evaluating the Impact of Educational Interventions on Patients and Communities: A Conceptual Framework.

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Bzowyckyj, Andrew S; Dow, Alan; Knab, Mary S

2017-11-01

Health professions education programs can have direct effects on patients and communities as well as on learners. However, few studies have examined the patient and community outcomes of educational interventions. To better integrate education and health care delivery, educators and researchers would benefit from a unifying framework to guide the planning of educational interventions and evaluation of their impact on patients.The authors of this Perspective mirrored approaches from Miller's pyramid of educational assessment and Moore and colleagues' framework for evaluating continuing professional development to propose a conceptual framework for evaluating the impact of educational interventions on patients and communities. This proposed framework, which complements these existing frameworks for evaluating the impact of educational interventions on learners, includes four levels: (1) interaction; (2) acceptability; (3) individual outcomes (i.e., knowledge, skills, activation, behaviors, and individual health indicators); and (4) population outcomes (i.e., community health indicators, capacity, and disparities). The authors describe measures and outcomes at each level and provide an example of the application of their new conceptual framework.The authors encourage educators and researchers to use this conceptual framework to evaluate the impact of educational interventions on patients and to more clearly identify and define which educational interventions strengthen communities and enhance overall health outcomes.

Applying the chronicle workshop as a method for evaluating participatory interventions

DEFF Research Database (Denmark)

Poulsen, Signe; Ipsen, Christine; Gish, Liv

2015-01-01

Despite the growing interest for process evaluation in participatory interventions, studies examining specific methods for process evaluation are lacking. In this paper, we propose a new method for process evaluation – the chronicle workshop. The chronicle workshop has not previously been used...... productivity and well-being. In all cases, we saw that the chronicle workshop gave valuable information about the intervention process and that it initiated a joint reflection among participants from different departments. The chronicle workshop makes it possible to better understand the results...

A RE-AIM evaluation of theory-based physical activity interventions.

Science.gov (United States)

Antikainen, Iina; Ellis, Rebecca

2011-04-01

Although physical activity interventions have been shown to effectively modify behavior, little research has examined the potential of these interventions for adoption in real-world settings. The purpose of this literature review was to evaluate the external validity of 57 theory-based physical activity interventions using the RE-AIM framework. The physical activity interventions included were more likely to report on issues of internal, rather than external validity and on individual, rather than organizational components of the RE-AIM framework, making the translation of many interventions into practice difficult. Furthermore, most studies included motivated, healthy participants, thus reducing the generalizability of the interventions to real-world settings that provide services to more diverse populations. To determine if a given intervention is feasible and effective in translational research, more information should be reported about the factors that affect external validity.

Additional Interventions to Enhance the Effectiveness of Individual Placement and Support: A Rapid Evidence Assessment

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Naomi Boycott

2012-01-01

Full Text Available Topic. Additional interventions used to enhance the effectiveness of individual placement and support (IPS. Aim. To establish whether additional interventions improve the vocational outcomes of IPS alone for people with severe mental illness. Method. A rapid evidence assessment of the literature was conducted for studies where behavioural or psychological interventions have been used to supplement standard IPS. Published and unpublished empirical studies of IPS with additional interventions were considered for inclusion. Conclusions. Six published studies were found which compared IPS alone to IPS plus a supplementary intervention. Of these, three used skills training and three used cognitive remediation. The contribution of each discrete intervention is difficult to establish. Some evidence suggests that work-related social skills and cognitive training are effective adjuncts, but this is an area where large RCTs are required to yield conclusive evidence.

Evaluation of Adherence to Nutritional Intervention Through Trajectory Analysis.

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Sevilla-Villanueva, B; Gibert, K; Sanchez-Marre, M; Fito, M; Covas, M I

2017-05-01

Classical pre-post intervention studies are often analyzed using traditional statistics. Nevertheless, the nutritional interventions have small effects on the metabolism and traditional statistics are not enough to detect these subtle nutrient effects. Generally, this kind of studies assumes that the participants are adhered to the assigned dietary intervention and directly analyzes its effects over the target parameters. Thus, the evaluation of adherence is generally omitted. Although, sometimes, participants do not effectively adhere to the assigned dietary guidelines. For this reason, the trajectory map is proposed as a visual tool where dietary patterns of individuals can be followed during the intervention and can also be related with nutritional prescriptions. The trajectory analysis is also proposed allowing both analysis: 1) adherence to the intervention and 2) intervention effects. The analysis is made by projecting the differences of the target parameters over the resulting trajectories between states of different time-stamps which might be considered either individually or by groups. The proposal has been applied over a real nutritional study showing that some individuals adhere better than others and some individuals of the control group modify their habits during the intervention. In addition, the intervention effects are different depending on the type of individuals, even some subgroups have opposite response to the same intervention.

Parents Questioning Immunization: Evaluation of an Intervention

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Gust, Deborah A.; Kennedy, Allison; Weber, Deanne; Evans, Geoff; Kong, Yuan; Salmon, Daniel

2009-01-01

Objectives: To compare attitudes of parents who filed or considered filing an exemption to school immunization requirements and/or would not have their child immunized if it were not required by law (cases) to controls. To develop and evaluate a brochure intervention for parents considering an exemption. Methods: Interviews, focus groups, mailed…

OARSI Clinical Trials Recommendations

DEFF Research Database (Denmark)

Emery, C. A.; Roos, Ewa M.; Verhagen, E.

2015-01-01

The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers...... internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations...

Quantitative assessment of the effects of chitosan intervention on blood pressure control

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Huang H

2017-12-01

Full Text Available Haohai Huang,1,* Ying Zou,2,3,* Honggang Chi2 1Department of Clinical Pharmacy, Dongguan Third People’s Hospital, Affiliated Dongguan Shilong People’s Hospital of Southern Medical University, Dongguan, 2Department of Traditional Chinese Medicine, Scientific Research Platform, The Second Clinical Medical College, Guangdong Medical University, Dongguan, 3Key Laboratory for Medical Molecular Diagnostics of Guangdong Province, Guangdong Medical University, Dongguan, China *These authors contributed equally to this work Background: Chitosan is a popular dietary fiber often used to reduce dietary fat absorption to control weight and blood lipids. However, its effects on blood pressure (BP have not been fully elucidated. We evaluated the effects of chitosan administration on systolic blood pressure (SBP and diastolic blood pressure (DBP through a pooled analysis of available randomized controlled trials (RCTs. Materials and methods: Electronic searches were conducted in Medline, Cochrane Library, Scopus, and EMBASE to identify relevant human placebo-control RCTs. Trials that reported BP changes from baseline to study endpoint in patients receiving treatment of chitosan were included for analysis. Weighted mean difference (WMD and 95% CIs were pooled using fixed-effects or random-effects models. Statistical heterogeneity, prespecified subgroup, publication bias, sensitivity analysis, and meta-regression assessments were also tested. Results: Six hundred and seventeen participants from eight trials with 10 arms were included. Overall, chitosan administration did not significantly lower SBP (WMD: -1.41 mmHg, 95% CI: -3.29 to 0.47; P=0.14 and DBP (WMD: -0.61 mmHg, 95% CI: -1.75 to 0.52; P=0.29. However, our subgroup analyses indicated that chitosan consumption significantly reduced DBP in shorter-term (<12 weeks and higher-dose (>2.4 g/day arms. Funnel plots or Egger’s tests analysis (P=0.36 and 0.43 for SBP and DBP, respectively demonstrated that

Pilot Evaluation of a Web-Based Intervention Targeting Sexual Health Service Access

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Brown, K. E.; Newby, K.; Caley, M.; Danahay, A.; Kehal, I.

2016-01-01

Sexual health service access is fundamental to good sexual health, yet interventions designed to address this have rarely been implemented or evaluated. In this article, pilot evaluation findings for a targeted public health behavior change intervention, delivered via a website and web-app, aiming to increase uptake of sexual health services among…

Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study.

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Wareham, K J; Hyde, R M; Grindlay, D; Brennan, M L; Dean, R S

2017-10-04

Randomised controlled trials (RCTs) are a key component of the veterinary evidence base. Sample sizes and defined outcome measures are crucial components of RCTs. To describe the sample size and number of outcome measures of veterinary RCTs either funded by the pharmaceutical industry or not, published in 2011. A structured search of PubMed identified RCTs examining the efficacy of pharmaceutical interventions. Number of outcome measures, number of animals enrolled per trial, whether a primary outcome was identified, and the presence of a sample size calculation were extracted from the RCTs. The source of funding was identified for each trial and groups compared on the above parameters. Literature searches returned 972 papers; 86 papers comprising 126 individual trials were analysed. The median number of outcomes per trial was 5.0; there were no significant differences across funding groups (p = 0.133). The median number of animals enrolled per trial was 30.0; this was similar across funding groups (p = 0.302). A primary outcome was identified in 40.5% of trials and was significantly more likely to be stated in trials funded by a pharmaceutical company. A very low percentage of trials reported a sample size calculation (14.3%). Failure to report primary outcomes, justify sample sizes and the reporting of multiple outcome measures was a common feature in all of the clinical trials examined in this study. It is possible some of these factors may be affected by the source of funding of the studies, but the influence of funding needs to be explored with a larger number of trials. Some veterinary RCTs provide a weak evidence base and targeted strategies are required to improve the quality of veterinary RCTs to ensure there is reliable evidence on which to base clinical decisions.

Comparative efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion

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Regnier, Stephane A; Larsen, Michael; Bezlyak, Vladimir

2015-01-01

OBJECTIVE: To compare the efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion (BRVO). DESIGN: Randomised controlled trials (RCTs) evaluating the efficacy and safety of approved treatments for macular oedema secondary to BRVO were identified from...... an updated systematic review. SETTING: A Bayesian network meta-analysis of RCTs of treatments for macular oedema secondary to BRVO. INTERVENTIONS: Ranibizumab 0.5 mg pro re nata, aflibercept 2 mg monthly (2q4), dexamethasone 0.7 mg implant, laser photocoagulation, ranibizumab+laser, or sham intervention...... pressure (IOP)/ocular hypertension (OH). RESULTS: 8 RCTs were identified for inclusion with 1743 adult patients. The probability of being the most efficacious treatment at month 6 or 12 based on letters gained was 54% for ranibizumab monotherapy, 30% for aflibercept, 16% for ranibizumab plus laser...

Randomized controlled trials of HIV/AIDS prevention and treatment in Africa: results from the Cochrane HIV/AIDS Specialized Register.

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Babalwa Zani

Full Text Available INTRODUCTION: To effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs. Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008. OBJECTIVES: To describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008. METHODS: We searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders. RESULTS: Our search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20, Zambia (12 and Zimbabwe (9. The median sample size was 628 (range 33-9645. Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials. CONCLUSION: Prevention trials dominate the trial

Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

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Mary Leamy

Full Text Available OBJECTIVE: To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. DESIGN: Process evaluation nested within a cluster randomised controlled trial (RCT. PARTICIPANTS: 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. SETTING: 14 community-based mental health teams in two UK sites (one urban, one semi-rural who received the intervention. RESULTS: The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. CONCLUSIONS: Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would

[Application of Chinese Medical Syndrome Scores in Effectiveness Evaluation: a Critical Appraisal of 240 Randomized Controlled Trials].

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Luo, Hui; Liao, Xing; Wang, Qian

2015-10-01

To explore the role of traditional Chinese medicine (TCM) syndrome scores in effectiveness evaluation of clinical studies. Randomized controlled trials (RCTs) of TCM published in five journals in 2013 were retrieved, including Journal of Traditional Chinese Medicine (JTCM), Chinese Journal of Integrated Traditional and Western Medicine (CJITWM), Chinese Journal of Integrative Medicine (CJIM), Evidence-Based Complementary and Alternative Medicine (ECAM), and American Journal of Chinese Medicine (AJCM). The details of TCM syndrome scores and other relevant factors reported in articles were extracted and analyzed. Descriptive statistics and Chi-square test were used to describe general features of inclusive studies, ratios of reports on CM syndrome scores in each journal, formulated evidence, adopted evaluation rules, important degrees. The difference in the application rate of CM syndrome scores were compared in various diseases, diseases with or without CM syndrome typing, places where clinical studies were implemented, and different journals. A total of 240 RCTs were included, involving 178 published in Chinese version and 62 in English version. CM syndrome scores were used for effectiveness evaluation in 27.1% (65/240) of RCTs, of which, the highest application percentage was 35.3% (18/51) in RCTs published in CJITWM, and the lowest was 0 (0/7) in RCTs published in AJCM. There were 17 methods for grading TCM syndrome scores, of which Guideline for Clinical Research of New Chinese Herbal Medicine was most commonly used. Detailed grading standards for CM syndrome scores were reported in 46 RCTs, and CM syndrome scores were taken as primary or secondary outcomes in 6 RCTs. When describing the percentages of RCTs adopting TCM syndrome score by diseases classification, the lowest was 9.5% (2/21) in mental and behavioral disorders, and the highest was 39.1% (9/23) in endocrine, nutritional, and metabolic diseases. RCTs with TCM syndrome differentiation had a higher

Face to face interventions for informing or educating parents about early childhood vaccination.

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Kaufman, Jessica; Synnot, Anneliese; Ryan, Rebecca; Hill, Sophie; Horey, Dell; Willis, Natalie; Lin, Vivian; Robinson, Priscilla

2013-05-31

Childhood vaccination (also described as immunisation) is an important and effective way to reduce childhood illness and death. However, there are many children who do not receive the recommended vaccines because their parents do not know why vaccination is important, do not understand how, where or when to get their children vaccinated, disagree with vaccination as a public health measure, or have concerns about vaccine safety.Face to face interventions to inform or educate parents about routine childhood vaccination may improve vaccination rates and parental knowledge or understanding of vaccination. Such interventions may describe or explain the practical and logistical factors associated with vaccination, and enable parents to understand the meaning and relevance of vaccination for their family or community. To assess the effects of face to face interventions for informing or educating parents about early childhood vaccination on immunisation uptake and parental knowledge. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7); MEDLINE (OvidSP) (1946 to July 2012); EMBASE + Embase Classic (OvidSP) (1947 to July 2012); CINAHL (EbscoHOST) (1981 to July 2012); PsycINFO (OvidSP) (1806 to July 2012); Global Health (CAB) (1910 to July 2012); Global Health Library (WHO) (searched July 2012); Google Scholar (searched September 2012), ISI Web of Science (searched September 2012) and reference lists of relevant articles. We searched for ongoing trials in The International Clinical Trials Registry Platform (ICTRP) (searched August 2012) and for grey literature in The Grey Literature Report and OpenGrey (searched August 2012). We also contacted authors of included studies and experts in the field. There were no language or date restrictions. Randomised controlled trials (RCTs) and cluster RCTs evaluating the effects of face to face interventions delivered to individual parents or groups of parents to inform or educate

Social media interventions for diet and exercise behaviours: a systematic review and meta-analysis of randomised controlled trials.

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Williams, Gillian; Hamm, Michele P; Shulhan, Jocelyn; Vandermeer, Ben; Hartling, Lisa

2014-02-12

To conduct a systematic review of randomised controlled trials (RCTs) examining the use of social media to promote healthy diet and exercise in the general population. MEDLINE, CENTRAL, ERIC, PubMed, CINAHL, Academic Search Complete, Alt Health Watch, Health Source, Communication and Mass Media Complete, Web of Knowledge and ProQuest Dissertation and Thesis (2000-2013). RCTs of social media interventions promoting healthy diet and exercise behaviours in the general population were eligible. Interventions using social media, alone or as part of a complex intervention, were included. Study quality was assessed using the Cochrane Risk of Bias Tool. We describe the studies according to the target populations, objectives and nature of interventions, outcomes examined, and results and conclusions. We extracted data on the primary and secondary outcomes examined in each study. Where the same outcome was assessed in at least three studies, we combined data in a meta-analysis. 22 studies were included. Participants were typically middle-aged Caucasian women of mid-to-high socioeconomic status. There were a variety of interventions, comparison groups and outcomes. All studies showed a decrease in programme usage throughout the intervention period. Overall, no significant differences were found for primary outcomes which varied across studies. Meta-analysis showed no significant differences in changes in physical activity (standardised mean difference (SMD) 0.13 (95% CI -0.04 to 0.30), 12 studies) and weight (SMD -0.00 (95% CI -0.19 to 0.19), 10 studies); however, pooled results from five studies showed a significant decrease in dietary fat consumption with social media (SMD -0.35 (95% CI -0.68 to -0.02)). Social media may provide certain advantages for public health interventions; however, studies of social media interventions to date relating to healthy lifestyles tend to show low levels of participation and do not show significant differences between groups in key outcomes.

Using mixed methods to develop and evaluate complex interventions in palliative care research.

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Farquhar, Morag C; Ewing, Gail; Booth, Sara

2011-12-01

there is increasing interest in combining qualitative and quantitative research methods to provide comprehensiveness and greater knowledge yield. Mixed methods are valuable in the development and evaluation of complex interventions. They are therefore particularly valuable in palliative care research where the majority of interventions are complex, and the identification of outcomes particularly challenging. this paper aims to introduce the role of mixed methods in the development and evaluation of complex interventions in palliative care, and how they may be used in palliative care research. the paper defines mixed methods and outlines why and how mixed methods are used to develop and evaluate complex interventions, with a pragmatic focus on design and data collection issues and data analysis. Useful texts are signposted and illustrative examples provided of mixed method studies in palliative care, including a detailed worked example of the development and evaluation of a complex intervention in palliative care for breathlessness. Key challenges to conducting mixed methods in palliative care research are identified in relation to data collection, data integration in analysis, costs and dissemination and how these might be addressed. the development and evaluation of complex interventions in palliative care benefit from the application of mixed methods. Mixed methods enable better understanding of whether and how an intervention works (or does not work) and inform the design of subsequent studies. However, they can be challenging: mixed method studies in palliative care will benefit from working with agreed protocols, multidisciplinary teams and engaging staff with appropriate skill sets.

Considerations on Intervention Goal and Efficacy Evaluation of Traditional Chinese Medicine in the Treatment of Neurological Diseases

Institute of Scientific and Technical Information of China (English)

XIE Ren-ming; DU Bao-xin; HUANG Yan; ZHOU Dao-you; WANG yong-yan; HUANG pei-xin

2007-01-01

In the last several years, traditional Chinese medicine (TCM) has made much progress in the treatment of neurological diseases. The living space of TCM in neurological diseases lies in refractory diseases, aging and chronic diseases caused by multiple factors as well as sub-health state and chronic fatigue state. The effect model of TCM mainly consists of whole effect, self-organization,self-stable model, holographic effect and butterfly effect. The effective point of TCM in neurological diseases lies mainly in end-points and health-related events. Moreover, TCM has advantages in the evaluation of symptoms, syndrome and quality of life (QOL). Some key indexes should be included when evaluating the efficacy of TCM in neurological diseases. Meanwhile, the advantages of TCM such as end-points, health-related events and QOL should be highlighted. Multi-subject researching methods could be adopted to make a comprehensive evaluation of subjective and objective indexes.The clinical evidence on the TCM efficacy evaluation may come from RCTs, and other types of designs can also be considered.

Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms

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Guthrie, Katherine A.; LaCroix, Andrea Z.; Ensrud, Kristine E.; Joffe, Hadine; Newton, Katherine M.; Reed, Susan D.; Caan, Bette; Carpenter, Janet S.; Cohen, Lee S.; Freeman, Ellen W.; Larson, Joseph C.; Manson, JoAnn E.; Rexrode, Kathy; Skaar, Todd C.; Sternfeld, Barbara; Anderson, Garnet L.

2015-01-01

Objective To describe the effects of six interventions for menopausal vasomotor symptoms relative to control in a pooled analysis, facilitating translation of the results for clinicians and symptomatic women. The MsFLASH (Menopause Strategies: Finding Lasting Answers for Symptoms and Health) network tested these interventions in three randomized clinical trials (RCTs). Methods An analysis of pooled individual-level data from three RCTs is presented. Participants were 899 peri- and postmenopausal women with at least 14 bothersome vasomotor symptoms/week. Interventions included escitalopram 10–20 mg/day, non-aerobic yoga, aerobic exercise, 1.8 g/day omega-3 fatty acid supplementation, low-dose oral 17-beta-estradiol 0.5-mg/day, and low-dose venlafaxine XR 75-mg/day. The main outcome measures were changes from baseline in mean daily vasomotor symptoms frequency and bother during 8–12 weeks of treatment. Linear regression models estimated differences in outcomes between each intervention and corresponding control group, adjusted for baseline characteristics. Models included trial-specific intercepts, effects of the baseline outcome measure, and time. Results The 8-week reduction in vasomotor symptoms frequency from baseline relative to placebo was similar for escitalopram at −1.4/day (95% CI: −2.7 to −0.2), low-dose estradiol at −2.4 (95% CI: −3.4 to −1.3), and venlafaxine at −1.8 (95% CI: −2.8 to −0.8); vasomotor symptoms bother reduction was minimal and did not vary across these three pharmacologic interventions (means −0.2 to −0.3 relative to placebo). No effects on vasomotor symptoms frequency or bother were seen with aerobic exercise, yoga or omega-3 supplements. Conclusions These analyses suggest that escitalopram, low-dose estradiol, and venlafaxine provide comparable, modest reductions in vasomotor symptoms frequency and bother among women with moderate hot flushes. Clinical Trial Registration ClinicalTrials.gov, www

Testing self-regulation interventions to increase walking using factorial randomized N-of-1 trials.

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Sniehotta, Falko F; Presseau, Justin; Hobbs, Nicola; Araújo-Soares, Vera

2012-11-01

To investigate the suitability of N-of-1 randomized controlled trials (RCTs) as a means of testing the effectiveness of behavior change techniques based on self-regulation theory (goal setting and self-monitoring) for promoting walking in healthy adult volunteers. A series of N-of-1 RCTs in 10 normal and overweight adults ages 19-67 (M = 36.9 years). We randomly allocated 60 days within each individual to text message-prompted daily goal-setting and/or self-monitoring interventions in accordance with a 2 (step-count goal prompt vs. alternative goal prompt) × 2 (self-monitoring: open vs. blinded Omron-HJ-113-E pedometer) factorial design. Aggregated data were analyzed using random intercept multilevel models. Single cases were analyzed individually. The primary outcome was daily pedometer step counts over 60 days. Single-case analyses showed that 4 participants significantly increased walking: 2 on self-monitoring days and 2 on goal-setting days, compared with control days. Six participants did not benefit from the interventions. In aggregated analyses, mean step counts were higher on goal-setting days (8,499.9 vs. 7,956.3) and on self-monitoring days (8,630.3 vs. 7,825.9). Multilevel analyses showed a significant effect of the self-monitoring condition (p = .01), the goal-setting condition approached significance (p = .08), and there was a small linear increase in walking over time (p = .03). N-of-1 randomized trials are a suitable means to test behavioral interventions in individual participants.

Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus.

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Chew, Boon How; Vos, Rimke C; Metzendorf, Maria-Inti; Scholten, Rob Jpm; Rutten, Guy Ehm

2017-09-27

Many adults with type 2 diabetes mellitus (T2DM) experience a psychosocial burden and mental health problems associated with the disease. Diabetes-related distress (DRD) has distinct effects on self-care behaviours and disease control. Improving DRD in adults with T2DM could enhance psychological well-being, health-related quality of life, self-care abilities and disease control, also reducing depressive symptoms. To assess the effects of psychological interventions for diabetes-related distress in adults with T2DM. We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, BASE, WHO ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was December 2014 for BASE and 21 September 2016 for all other databases. We included randomised controlled trials (RCTs) on the effects of psychological interventions for DRD in adults (18 years and older) with T2DM. We included trials if they compared different psychological interventions or compared a psychological intervention with usual care. Primary outcomes were DRD, health-related quality of life (HRQoL) and adverse events. Secondary outcomes were self-efficacy, glycosylated haemoglobin A1c (HbA1c), blood pressure, diabetes-related complications, all-cause mortality and socioeconomic effects. Two review authors independently identified publications for inclusion and extracted data. We classified interventions according to their focus on emotion, cognition or emotion-cognition. We performed random-effects meta-analyses to compute overall estimates. We identified 30 RCTs with 9177 participants. Sixteen trials were parallel two-arm RCTs, and seven were three-arm parallel trials. There were also seven cluster-randomised trials: two had four arms, and the remaining five had two arms. The median duration of the intervention was six months (range 1 week to 24 months), and the median follow-up period was 12 months (range 0 to 12 months). The trials included a wide spectrum of interventions and were both

A systematic review of eHealth behavioral interventions targeting smoking, nutrition, alcohol, physical activity and/or obesity for young adults.

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Oosterveen, Emilie; Tzelepis, Flora; Ashton, Lee; Hutchesson, Melinda J

2017-06-01

A systematic review of randomized control trials (RCT) was undertaken to evaluate the effectiveness of eHealth behavioral interventions aiming to improve smoking rates, nutrition behaviors, alcohol intake, physical activity levels and/or obesity (SNAPO) in young adults. Seven electronic databases were searched for RCTs published in English from 2000 to April 2015 and evaluating eHealth interventions aiming to change one or multiple SNAPO outcomes, and including young adult (18-35years) participants. Of 2,159 articles identified, 45 studies met the inclusion criteria. Most interventions targeted alcohol (n=26), followed by smoking (n=7), physical activity (n=4), obesity (n=4) and nutrition (n=1). Three interventions targeted multiple behaviors. The eHealth interventions were most often delivered via websites (79.5%). Most studies (n=32) compared eHealth interventions to a control group (e.g. waiting list control, minimal intervention), with the majority (n=23) showing a positive effect on a SNAPO outcome at follow-up. Meta-analysis demonstrated a significantly lower mean number of drinks consumed/week in brief web or computer-based interventions compared to controls (Mean Difference -2.43 [-3.54, -1.32], PeHealth delivery modes, with inconsistent results across target behaviors and technology types. Nine studies compared eHealth to other modes of delivery (e.g. in person) with all finding no difference in SNAPO outcomes between groups at follow-up. This review provides some evidence for the efficacy of eHealth SNAPO interventions for young adults, particularly in the short-term and for alcohol interventions. But there is insufficient evidence for their efficacy in the longer-term, as well as which mode of delivery is most effective. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Interventions to change the behaviour of health professionals and the organisation of care to promote weight reduction in overweight and obese people.

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Flodgren, Gerd; Deane, Katherine; Dickinson, Heather O; Kirk, Sara; Alberti, Hugh; Beyer, Fiona R; Brown, James G; Penney, Tarra L; Summerbell, Carolyn D; Eccles, Martin P

2010-03-17

The prevalence of obesity is increasing globally and will, if left unchecked, have major implications for both population health and costs to health services. To assess the effectiveness of strategies to change the behaviour of health professionals and the organisation of care to promote weight reduction in overweight and obese people. We updated the search for primary studies in the following databases, which were all interrogated from the previous (version 2) search date to May 2009: The Cochrane Central Register of Controlled Trials (which at this time incorporated all EPOC Specialised Register material) (The Cochrane Library 2009, Issue 1), MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO), and PsycINFO (Ovid). We identified further potentially relevant studies from the reference lists of included studies. Randomised controlled trials (RCTs) that compared routine provision of care with interventions aimed either at changing the behaviour of healthcare professionals or the organisation of care to promote weight reduction in overweight or obese adults. Two reviewers independently extracted data and assessed study quality. We included six RCTs, involving more than 246 health professionals and 1324 overweight or obese patients. Four of the trials targeted professionals and two targeted the organisation of care. Most of the studies had methodological or reporting weaknesses indicating a risk of bias.Meta-analysis of three trials that evaluated educational interventions aimed at GPs suggested that, compared to standard care, such interventions could reduce the average weight of patients after a year (by 1.2 kg, 95% CI -0.4 to 2.8 kg); however, there was moderate unexplained heterogeneity between their results (I(2) = 41%). One trial found that reminders could change doctors' practice, resulting in a significant reduction in weight among men (by 11.2 kg, 95% CI 1.7 to 20.7 kg) but not among women (who reduced weight by 1.3 kg, 95% CI -4.1 to 6.7 kg). One trial found that

Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity: the baby milk intervention and trial.

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Lakshman, Rajalakshmi; Griffin, Simon; Hardeman, Wendy; Schiff, Annie; Kinmonth, Ann Louise; Ong, Ken K

2014-01-01

We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial

Directory of Open Access Journals (Sweden)

Rajalakshmi Lakshman

2014-01-01

Full Text Available Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients and healthcare professionals (intervention deliverers to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

Mindfulness-Based Interventions for People Diagnosed with a Current Episode of an Anxiety or Depressive Disorder: A Meta-Analysis of Randomised Controlled Trials

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Strauss, Clara; Cavanagh, Kate; Oliver, Annie; Pettman, Danelle

2014-01-01

Objective Mindfulness-based interventions (MBIs) can reduce risk of depressive relapse for people with a history of recurrent depression who are currently well. However, the cognitive, affective and motivational features of depression and anxiety might render MBIs ineffective for people experiencing current symptoms. This paper presents a meta-analysis of randomised controlled trials (RCTs) of MBIs where participants met diagnostic criteria for a current episode of an anxiety or depressive disorder. Method Post-intervention between-group Hedges g effect sizes were calculated using a random effects model. Moderator analyses of primary diagnosis, intervention type and control condition were conducted and publication bias was assessed. Results Twelve studies met inclusion criteria (n = 578). There were significant post-intervention between-group benefits of MBIs relative to control conditions on primary symptom severity (Hedges g = −0.59, 95% CI = −0.12 to −1.06). Effects were demonstrated for depressive symptom severity (Hedges g = −0.73, 95% CI = −0.09 to −1.36), but not for anxiety symptom severity (Hedges g = −0.55, 95% CI = 0.09 to −1.18), for RCTs with an inactive control (Hedges g = −1.03, 95% CI = −0.40 to −1.66), but not where there was an active control (Hedges g = 0.03, 95% CI = 0.54 to −0.48) and effects were found for MBCT (Hedges g = −0.39, 95% CI = −0.15 to −0.63) but not for MBSR (Hedges g = −0.75, 95% CI = 0.31 to −1.81). Conclusions This is the first meta-analysis of RCTs of MBIs where all studies included only participants who were diagnosed with a current episode of a depressive or anxiety disorder. Effects of MBIs on primary symptom severity were found for people with a current depressive disorder and it is recommended that MBIs might be considered as an intervention for this population. PMID:24763812

Mindfulness-based interventions for people diagnosed with a current episode of an anxiety or depressive disorder: a meta-analysis of randomised controlled trials.

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Clara Strauss

Full Text Available OBJECTIVE: Mindfulness-based interventions (MBIs can reduce risk of depressive relapse for people with a history of recurrent depression who are currently well. However, the cognitive, affective and motivational features of depression and anxiety might render MBIs ineffective for people experiencing current symptoms. This paper presents a meta-analysis of randomised controlled trials (RCTs of MBIs where participants met diagnostic criteria for a current episode of an anxiety or depressive disorder. METHOD: Post-intervention between-group Hedges g effect sizes were calculated using a random effects model. Moderator analyses of primary diagnosis, intervention type and control condition were conducted and publication bias was assessed. RESULTS: Twelve studies met inclusion criteria (n = 578. There were significant post-intervention between-group benefits of MBIs relative to control conditions on primary symptom severity (Hedges g = -0.59, 95% CI = -0.12 to -1.06. Effects were demonstrated for depressive symptom severity (Hedges g = -0.73, 95% CI = -0.09 to -1.36, but not for anxiety symptom severity (Hedges g = -0.55, 95% CI = 0.09 to -1.18, for RCTs with an inactive control (Hedges g = -1.03, 95% CI = -0.40 to -1.66, but not where there was an active control (Hedges g = 0.03, 95% CI = 0.54 to -0.48 and effects were found for MBCT (Hedges g = -0.39, 95% CI = -0.15 to -0.63 but not for MBSR (Hedges g = -0.75, 95% CI = 0.31 to -1.81. CONCLUSIONS: This is the first meta-analysis of RCTs of MBIs where all studies included only participants who were diagnosed with a current episode of a depressive or anxiety disorder. Effects of MBIs on primary symptom severity were found for people with a current depressive disorder and it is recommended that MBIs might be considered as an intervention for this population.

Evaluability Assessment of an immunization improvement strategy in rural Burkina Faso: intervention theory versus reality, information need and evaluations.

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Sanou, Aboubakary; Kouyaté, Bocar; Bibeau, Gilles; Nguyen, Vinh-Kim

2011-08-01

An innovative immunization improvement strategy was proposed by the CRSN (Centre de Recherche en Santé de Nouna) to improve the low coverage rate for children aged 0-11 months in the health district of Nouna in Burkina Faso. This article reports on the Evaluability Assessment (EA) study that aimed to orient decisions for its evaluation in close relationship with the information needs of the stakeholders. Various methods were used, including document reviews, individual interviews, focus group discussions, meetings, literature reviews and site visits. A description of the intervention theory and philosophy is provided with its logic models and its reality documented. Lessons on the procedure include the importance of the position of the evaluability assessor, the value of replicating some steps of the assessment and the relationships between EA and process evaluation. The evaluability study concludes that the intervention had some evaluable components. To satisfy the stakeholders' needs, the initially planned community randomized controlled trial can be maintained and complemented with a process evaluation. There is a need to provide sufficient information on the cost of the intervention. This will inform decision makers on the possibility of replicating the intervention in other contexts. Copyright © 2010 Elsevier Ltd. All rights reserved.

Effectiveness of Trigger Point Manual Treatment on the Frequency, Intensity, and Duration of Attacks in Primary Headaches: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

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Luca Falsiroli Maistrello

2018-04-01

Full Text Available BackgroundA variety of interventions has been proposed for symptomatology relief in primary headaches. Among these, manual trigger points (TrPs treatment gains popularity, but its effects have not been investigated yet.ObjectiveThe aim was to establish the effectiveness of manual TrP compared to minimal active or no active interventions in terms of frequency, intensity, and duration of attacks in adult people with primary headaches.MethodsWe searched MEDLINE, COCHRANE, Web Of Science, and PEDro databases up to November 2017 for randomized controlled trials (RCTs. Two independent reviewers appraised the risk-of-bias (RoB and the grading of recommendations, assessment, development, and evaluation (GRADE to evaluate the overall quality of evidence.ResultsSeven RCTs that compared manual treatment vs minimal active intervention were included: 5 focused on tension-type headache (TTH and 2 on Migraine (MH; 3 out of 7 RCTs had high RoB. Combined TTH and MH results show statistically significant reduction for all outcomes after treatment compared to controls, but the level of evidence was very low. Subgroup analysis showed a statistically significant reduction in attack frequency (no. of attacks per month after treatment in TTH (MD −3.50; 95% CI from −4.91 to −2.09; 4 RCTs and in MH (MD −1.92; 95% CI from −3.03 to −0.80; 2 RCTs. Pain intensity (0–100 scale was reduced in TTH (MD −12.83; 95% CI from −19.49 to −6.17; 4 RCTs and in MH (MD −13.60; 95% CI from −19.54 to −7.66; 2RCTs. Duration of attacks (hours was reduced in TTH (MD −0.51; 95% CI from −0.97 to −0.04; 2 RCTs and in MH (MD −10.68; 95% CI from −14.41 to −6.95; 1 RCT.ConclusionManual TrPs treatment of head and neck muscles may reduce frequency, intensity, and duration of attacks in TTH and MH, but the quality of evidence according to GRADE approach was very low for the presence of few studies, high RoB, and imprecision of results.

Methodological limitations of psychosocial interventions in patients with an implantable cardioverter-defibrillator (ICD A systematic review

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Ockene Ira S

2009-12-01

on anxiety and physical functioning in ICD patients. However, these initial findings must be interpreted cautiously because of important methodological limitations. Future studies should be designed as large RCTs, whose design takes into account the specific challenges associated with the evaluation of behavioural interventions.

Too much ‘Dreaming’: Evaluations of the Northern Territory National Emergency Response Intervention 2007–2012

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Jon Altman

2012-12-01

Full Text Available The Northern Territory National Emergency Response Intervention (the Intervention of 2007 was a bold experiment by the Howard Government. The Intervention was developed quickly without comprehensive policy development based on evidence or consultation. During its five-year statutory life (ending August 2012, the absence of coherent policy logic has seen the Intervention fundamentally reframed by the Rudd and Gillard Governments. The unprecedented and controversial nature of the Intervention has seen extraordinary levels of monitoring, review and evaluation, but the absence of an overarching evaluation strategy has resulted in a fragmented and confused approach. In this article, we do not seek to critique the Intervention itself or to assess whether these multiple monitoring and evaluation exercises have been successes or failures. Indeed, our review illustrates that in highly contested policy areas, notions of success, failure and the evaluations themselves become politically charged. Instead we make a series of critical observations regarding this contradictory messiness of evaluations, using political science and anthropological frameworks to draw wider conclusions about the nature and logic of evaluation fetishism. We conclude that evaluations of the Intervention have not led to greater transparency, accountability and monitoring of outcomes and outputs. The Intervention evaluations instead are consistent with the view that they are both obfuscating mechanisms and techniques of governance designed to allay public concern and normalise the governance of marginalised Indigenous Australian spaces.

Rehabilitation Interventions for Upper Limb Function in the First Four Weeks Following Stroke: A Systematic Review and Meta-Analysis of the Evidence.

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Wattchow, Kimberley A; McDonnell, Michelle N; Hillier, Susan L

2018-02-01

To investigate the therapeutic interventions reported in the research literature and synthesize their effectiveness in improving upper limb (UL) function in the first 4 weeks poststroke. Electronic databases and trial registries were searched from inception until June 2016, in addition to searching systematic reviews by hand. Randomized controlled trials (RCTs), controlled trials, and interventional studies with pre/posttest design were included for adults within 4 weeks of any type of stroke with UL impairment. Participants all received an intervention of any physiotherapeutic or occupational therapeutic technique designed to address impairment or activity of the affected UL, which could be compared with usual care, sham, or another technique. Two reviewers independently assessed eligibility of full texts, and methodological quality of included studies was assessed using the Cochrane Risk of Bias Tool. A total of 104 trials (83 RCTs, 21 nonrandomized studies) were included (N=5225 participants). Meta-analyses of RCTs only (20 comparisons) and narrative syntheses were completed. Key findings included significant positive effects for modified constraint-induced movement therapy (mCIMT) (standardized mean difference [SMD]=1.09; 95% confidence interval [CI], .21-1.97) and task-specific training (SMD=.37; 95% CI, .05-.68). Evidence was found to support supplementary use of biofeedback and electrical stimulation. Use of Bobath therapy was not supported. Use of mCIMT and task-specific training was supported, as was supplementary use of biofeedback and electrical simulation, within the acute phase poststroke. Further high-quality studies into the initial 4 weeks poststroke are needed to determine therapies for targeted functional UL outcomes. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Multi-College Bystander Intervention Evaluation for Violence Prevention.

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Coker, Ann L; Bush, Heather M; Fisher, Bonnie S; Swan, Suzanne C; Williams, Corrine M; Clear, Emily R; DeGue, Sarah

2016-03-01

The 2013 Campus Sexual Violence Elimination Act requires U.S. colleges to provide bystander-based training to reduce sexual violence, but little is known about the efficacy of such programs for preventing violent behavior. This study provides the first multiyear evaluation of a bystander intervention's campus-level impact on reducing interpersonal violence victimization and perpetration behavior on college campuses. First-year students attending three similarly sized public university campuses were randomly selected and invited to complete online surveys in the spring terms of 2010-2013. On one campus, the Green Dot bystander intervention was implemented in 2008 (Intervention, n=2,979) and two comparison campuses had no bystander programming at baseline (Comparison, n=4,132). Data analyses conducted in 2014-2015 compared violence rates by condition over the four survey periods. Multivariable logistic regression was used to estimate violence risk on Intervention relative to Comparison campuses, adjusting for demographic factors and time (2010-2013). Interpersonal violence victimization rates (measured in the past academic year) were 17% lower among students attending the Intervention (46.4%) relative to Comparison (55.7%) campuses (adjusted rate ratio=0.83; 95% CI=0.79, 0.88); a similar pattern held for interpersonal violence perpetration (25.5% in Intervention; 32.2% in Comparison; adjusted rate ratio=0.79; 95% CI=0.71, 0.86). Violence rates were lower on Intervention versus Comparison campuses for unwanted sexual victimization, sexual harassment, stalking, and psychological dating violence victimization and perpetration (pSexual Violence Elimination Act bystander training requirements. Copyright © 2016 American Journal of Preventive Medicine. All rights reserved.

Effects of Group Counseling Programs, Cognitive Behavioral Therapy, and Sports Intervention on Internet Addiction in East Asia: A Systematic Review and Meta-Analysis.

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Liu, Jun; Nie, Jing; Wang, Yafeng

2017-11-28

To evaluate the effects of group counseling programs, cognitive behavioral therapy (CBT), and sports intervention on Internet addiction (IA), a systematic search in ten databases was performed to identify eligible studies without language restrictions up to January 2017. A meta-analysis and trial sequential analysis (TSA) was performed, respectively. A total of 58 randomized controlled trials (RCTs), which included 2871 participants, were incorporated into our meta-analysis. The results showed that group counseling programs, CBT, and sports intervention could significantly reduce IA levels (group counseling program: standardized mean difference (SMD), -1.37; 95% confidence interval (CI), -1.89 to -0.85; CBT: SMD, -1.88; 95% CI, -2.53 to -1.23; sports intervention: SMD, -1.70; 95% CI, -2.14 to -1.26). For group counseling programs, this treatment was more effective in four dimensions of IA, including time management, interpersonal and health issues, tolerance, and compulsive Internet use. For CBT, this treatment yielded a positive change in depression, anxiousness, aggressiveness, somatization, social insecurity, phobic anxiety, paranoid ideation, and psychoticism. For sports intervention, the significant effects were also observed in all dimensions of the IA scale. Each of group counseling programs, cognitive behavioral therapy, and sports intervention had a significant effect on IA and psychopathological symptoms. Sports intervention could improve withdrawal symptoms especially.

Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy

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Magnano Lucia

2007-09-01

Full Text Available Abstract Background Suboptimal translation of valid and relevant information in clinical practice is a problem for all health systems. Lack of information independent from commercial influences, limited efforts to actively implement evidence-based information and its limited comprehensibility are important determinants of this gap and may influence an excessive variability in physicians' prescriptions. This is quite noticeable in Italy, where the philosophy and methods of Evidence-Based Medicine still enjoy limited diffusion among practitioners. Academic detailing and pharmacist outreach visits are interventions of proven efficacy to make independent and evidence-based information available to physicians; this approach and its feasibility have not yet been tested on a large scale and, moreover, they have never been formally tested in Italy. Methods/Design Two RCTs are planned: 1 a two-arm cluster RCT, carried out in Emilia-Romagna and Friuli Venezia Giulia, will evaluate the effectiveness of small group meetings, randomising about 150 Primary Care Groups (corresponding to about 2000 GPs to pharmacist outreach visits on two different topics. Physicians' prescriptions (expressed as DDD per 1000 inhabitants/day, knowledge and attitudes (evaluated through the answers to a specific questionnaire will be compared for target drugs in the two groups (receiving/not receiving each topic. 2 A three-arm RCT, carried out in Sardinia, will evaluate both the effectiveness of one-to-one meetings (one pharmacist visiting one physician per time and of a 'new' information format (compared to information already available on changing physicians' prescription of specific drugs. About 900 single GPs will be randomised into three groups: physicians receiving a visit supported by "traditional" information material, those receiving a visit with "new" information material on the same topic and those not receiving any visit/material. Discussion The two proposed RCTs aim

An evaluation of an educational intervention in psychology of injury for athletic training students.

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Stiller-Ostrowski, Jennifer L; Gould, Daniel R; Covassin, Tracey

2009-01-01

"Psychosocial Intervention and Referral" is 1 of the 12 content areas in athletic training education programs, but knowledge gained and skill usage after an educational intervention in this area have never been evaluated. To evaluate the effectiveness of an educational intervention in increasing psychology-of-injury knowledge and skill usage in athletic training students (ATSs). Observational study. An accredited athletic training education program at a large Midwestern university. Participants included 26 ATSs divided into 2 groups: intervention group (4 men, 7 women; age = 21.4 +/- 0.67 years, grade point average = 3.37) and control group (7 men, 8 women; age = 21.5 +/- 3.8 years, grade point average = 3.27). All participants completed the Applied Sport Psychology for Athletic Trainers educational intervention. Psychology-of-injury knowledge tests and skill usage surveys were administered to all participants at the following intervals: baseline, intervention week 3, and intervention week 6. Retention tests were administered to intervention-group participants at 7 and 14 weeks after intervention. Analysis techniques included mixed-model analysis of variance (ANOVA) and repeated-measures ANOVA. The Applied Sport Psychology for Athletic Trainers educational intervention effectively increased psychology-of-injury knowledge (29-point increase from baseline to intervention week 6; F(2,23) = 29.358, P evaluating an educational intervention designed to improve ATSs' knowledge and skill usage revealed that the intervention was effective. Although both knowledge and skill usage scores decreased by the end of the retention period, the scores were still higher than baseline scores, indicating that the intervention was effective.

Interventions for Increasing Alcohol Treatment Utilization Among Patients with Alcohol Use Disorders from Emergency Departments: A Systematic Review.

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Simioni, Nicolas; Rolland, Benjamin; Cottencin, Olivier

2015-11-01

Alcohol use disorders (AUDs) are characterized by low treatment coverage. Emergency departments (EDs) have great potential to increase alcohol treatment coverage. While ED-based brief interventions (BIs) are rarely effective for reducing alcohol use and related consequences in people with AUDs, utilization of formal alcohol treatment has been demonstrated to be useful. Thus we conducted a systematic review to determine efficacious interventions for increasing subsequent alcohol treatment from EDs. A systematic search of the literature up to 31 December 2013 was undertaken in three electronic databases: PubMed, PsycINFO and The Cochrane Library. Only randomized controlled trials (RCTs), controlled clinical trials (CCTs) and non-randomized controlled trials (NRCTs) were included. A meta-analysis was judged inappropriate because of substantial discrepancies in term of interventions' characteristics across studies. From the 2182 identified records, 7 studies (4RCTs, 2 CCTs, 1NRCT) met inclusion criteria. Onsite brief advice (BA) was found efficacious in comparison to no active control condition, but no evidence of efficacy was found when compared to active control conditions. Referral to post-discharge BIs was not found efficacious either used alone or in addition to onsite BA. There is evidence, albeit limited, suggesting that more intensive interventions, such as referral to extended post-discharge interventions and onsite extended BI, might be useful. Based on the available evidence, onsite BA with leaflets appears to be the minimum level of intervention since it enables to actively intervene while fitting in the time concerns experienced in EDs. Further research is needed to confirm these findings given the limited quantity and quality of existing data and to determine whether more intensive interventions could actually be useful. Copyright © 2015 Elsevier Inc. All rights reserved.

Interventions for treating functional dysphonia in adults.

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Ruotsalainen, J H; Sellman, J; Lehto, L; Jauhiainen, M; Verbeek, J H

2007-07-18

Poor voice quality due to functional dysphonia can lead to a reduced quality of life. In occupations where voice use is substantial it can lead to a loss of employment. To evaluate the effectiveness of interventions to treat functional dysphonia in adults. We searched MEDLINE (PubMed, 1950 to 2006), EMBASE (1974 to 2006), CENTRAL (The Cochrane Library, Issue 2 2006), CINAHL (1983 to 2006), PsychINFO (1967 to 2006), Science Citation Index (1986 to 2006) and the Occupational Health databases OSH-ROM (to 2006). The date of the last search was 5(th) April 2006. Randomised controlled trials (RCTs) of interventions evaluating the effectiveness of treatments targeted at adults with functional dysphonia. For work-directed interventions interrupted time series and prospective cohort studies were also eligible. Two authors independently extracted data and assessed trial quality. Meta-analysis was performed where appropriate. We identified six randomised controlled trials including a total of 163 participants in intervention groups and 141 controls. One trial was high quality. Interventions were grouped into 1) Direct voice therapy 2) Indirect voice therapy 3) Combination of direct and indirect voice therapy and 4) Other treatments: pharmacological treatment and vocal hygiene instructions given by phoniatrist. No studies were found evaluating direct voice therapy on its own. One study did not show indirect voice therapy on its own to be effective when compared to no intervention. There is evidence from three studies for the effectiveness of a combination of direct and indirect voice therapy on self-reported vocal functioning (SMD -1.07; 95% CI -1.94 to -0.19), on observer-rated vocal functioning (WMD -13.00; 95% CI -17.92 to -8.08) and on instrumental assessment of vocal functioning (WMD -1.20; 95% CI -2.37 to -0.03) when compared to no intervention. The results of one study also show that the remedial effect remains significant for at least 14 weeks on self-reported vocal

How to Measure the Intervention Process? An Assessment of Qualitative and Quantitative Approaches to Data Collection in the Process Evaluation of Organizational Interventions.

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Abildgaard, Johan S; Saksvik, Per Ø; Nielsen, Karina

2016-01-01

Organizational interventions aiming at improving employee health and wellbeing have proven to be challenging to evaluate. To analyze intervention processes two methodological approaches have widely been used: quantitative (often questionnaire data), or qualitative (often interviews). Both methods are established tools, but their distinct epistemological properties enable them to illuminate different aspects of organizational interventions. In this paper, we use the quantitative and qualitative process data from an organizational intervention conducted in a national postal service, where the Intervention Process Measure questionnaire ( N = 285) as well as an extensive interview study ( N = 50) were used. We analyze what type of knowledge about intervention processes these two methodologies provide and discuss strengths and weaknesses as well as potentials for mixed methods evaluation methodologies.

How to Measure the Intervention Process? An Assessment of Qualitative and Quantitative Approaches to Data Collection in the Process Evaluation of Organizational Interventions

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Johan Simonsen Abildgaard

2016-09-01

Full Text Available Organizational interventions aiming at improving employee health and wellbeing have proven to be challenging to evaluate. To analyze intervention processes two methodological approaches have widely been used: quantitative (often questionnaire data, or qualitative (often interviews. Both methods are established tools, but their distinct epistemological properties enable them to illuminate different aspects of organizational interventions. In this paper, we use the quantitative and qualitative process data from an organizational intervention conducted in a national postal service, where the Intervention Process Measure questionnaire (N=285 as well as an extensive interview study (N= 50 were used. We analyze what type of knowledge about intervention processes these two methodologies provide and discuss strengths and weaknesses as well as potentials for mixed methods evaluation methodologies.

Cognitive-Based Interventions to Improve Mobility: A Systematic Review and Meta-analysis.

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Marusic, Uros; Verghese, Joe; Mahoney, Jeannette R

2018-06-01

A strong relation between cognition and mobility has been identified in aging, supporting a role for enhancement mobility through cognitive-based interventions. However, a critical evaluation of the consistency of treatment effects of cognitive-based interventions is currently lacking. The objective of this study was 2-fold: (1) to review the existing literature on cognitive-based interventions aimed at improving mobility in older adults and (2) to assess the clinical effectiveness of cognitive interventions on gait performance. A systematic review of randomized controlled trials (RCT) of cognitive training interventions for improving simple (normal walking) and complex (dual task walking) gait was conducted in February 2018. Older adults without major cognitive, psychiatric, neurologic, and/or sensory impairments were included. Random effect meta-analyses and a subsequent meta-regression were performed to generate overall cognitive intervention effects on single- and dual-task walking conditions. Ten RCTs met inclusion criteria, with a total of 351 participants included in this meta-analysis. Cognitive training interventions revealed a small effect of intervention on complex gait [effect size (ES) = 0.47, 95% confidence interval (CI) 0.13 to 0.81, P = .007, I 2  = 15.85%], but not simple gait (ES = 0.35, 95% CI -0.01 to 0.71, P = .057, I 2  = 57.32%). Moreover, a meta-regression analysis revealed that intervention duration, training frequency, total number of sessions, and total minutes spent in intervention were not significant predictors of improvement in dual-task walking speed, though there was a suggestive trend toward a negative association between dual-task walking speed improvements and individual training session duration (P = .067). This meta-analysis provides support for the fact that cognitive training interventions can improve mobility-related outcomes, especially during challenging walking conditions requiring higher-order executive

Adherence to internet-based mobile-supported stress management

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Zarski, A C; Lehr, D.; Berking, M.

2016-01-01

of this study was to investigate the influence of different guidance formats (content-focused guidance, adherence-focused guidance, and administrative guidance) on adherence and to identify predictors of nonadherence in an Internet-based mobile-supported stress management intervention (ie, GET.ON Stress......) for employees. Methods: The data from the groups who received the intervention were pooled from three randomized controlled trials (RCTs) that evaluated the efficacy of the same Internet-based mobile-supported stress management intervention (N=395). The RCTs only differed in terms of the guidance format...... of the predictors significantly predicted nonadherence. Conclusions: Guidance has been shown to be an influential factor in promoting adherence to an Internet-based mobile-supported stress management intervention. Adherence-focused guidance, which included email reminders and feedback on demand, was equivalent...

Evaluating process in child and family interventions: aggression prevention as an example.

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Tolan, Patrick H; Hanish, Laura D; McKay, Mary M; Dickey, Mitchell H

2002-06-01

This article reports on 2 studies designed to develop and validate a set of measures for use in evaluating processes of child and family interventions. In Study 1 responses from 187 families attending an outpatient clinic for child behavior problems were factor analyzed to identify scales, consistent across sources: Alliance (Satisfactory Relationship with Interventionist and Program Satisfaction), Parenting Skill Attainment, Child Cooperation During Session, Child Prosocial Behavior, and Child Aggressive Behavior. Study 2 focused on patterns of scale scores among 78 families taking part in a 22-week preventive intervention designed to affect family relationships, parenting, and child antisocial and prosocial behaviors. The factor structure identified in Study 1 was replicated. Scale construct validity was demonstrated through across-source convergence, sensitivity to intervention change, and ability to discriminate individual differences. Path analysis validated the scales' utility in explaining key aspects of the intervention process. Implications for evaluating processes in family interventions are discussed.

Evaluation and Socio-occupational Intervention in Bipolar and Schizophrenic Patients within a Multimodal Intervention Program- PRISMA.

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Díaz Zuluaga, Ana M; Duica, Kelly; Ruiz Galeano, Carlos; Vargas, Cristian; Agudelo Berruecos, Yuli; Ospina, Sigifredo; López-Jaramillo, Carlos

Functional improvement in bipolar and schizophrenic patients is one of the main aims of treatment. Nevertheless, there is no evidence about the effect of socio-occupational intervention within a multimodal intervention (MI) programme. To describe the socio-occupational profile and to evaluate the functional effect of a MI in bipolar I and schizophrenic patients. A prospective, longitudinal, therapeutic-comparative study was performed including 302 subjects (104 schizophrenic and 198 Bipolar Disorder I [BDI] patients), who were randomised into two groups, multimodal (psychiatry, psychology, medicine, occupational therapy, neuropsychology, and family therapy), or traditional intervention (psychiatry and medicine only). Several scales were applied to assess assertiveness, free time management, social abilities, general anxiety, self-care and performance in home, work and community tasks. After performing the longitudinal analysis, it was shown that the multimodal intervention was more effective than traditional intervention in general anxiety scores (P=.026) and development in home tasks (P=.03) in schizophrenic patients. No statistical differences were found in bipolar patients. The other variables showed improvement, however, their effect was similar in both intervention groups. Our study identified functional improvement in home tasks in schizophrenic patients after receiving multimodal intervention. Other variables also showed improvement for both interventions groups. Future studies, applying longer rehabilitation programs and other ecological strategies should be performed to identify the most effective interventions. Copyright © 2017 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Exploring Study Designs for Evaluation of Interventions Aimed to Reduce Occupational Diseases and Injuries

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Henk F. van der Molen

2016-03-01

Full Text Available Effective interventions to reduce work-related exposures are available for many types of work-related diseases or injuries. However, knowledge of the impact of these interventions on injury or disease outcomes is scarce due to practical and methodological reasons. Study designs are considered for the evaluation of occupational health interventions on occupational disease or injury. Latency and frequency of occurrence of the health outcomes are two important features when designing an evaluation study with occupational disease or occupational injury as an outcome measure. Controlled evaluation studies—giving strong indications for an intervention effect—seem more suitable for more frequently occurring injuries or diseases. Uncontrolled evaluation time or case series studies are an option for evaluating less frequently occurring injuries or diseases. Interrupted time series offer alternatives to experimental randomized controlled trials to give an insight into the effectiveness of preventive actions in the work setting to decision and policy makers.

Spin in RCTs of anxiety medication with a positive primary outcome : A comparison of concerns expressed by the US FDA and in the published literature

NARCIS (Netherlands)

Beijers, Lian; Jeronimus, Bertus F; Turner, Erick H; de Jonge, Peter; Roest, Annelieke M

2017-01-01

Objectives: This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper.

Poor quality of external validity reporting limits generalizability of overweight and/or obesity lifestyle prevention interventions in young adults: a systematic review.

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Partridge, S R; Juan, S J-H; McGeechan, K; Bauman, A; Allman-Farinelli, M

2015-01-01

Young adulthood is a high-risk life stage for weight gain. Evidence is needed to translate behavioural approaches into community practice to prevent weight gain in young adults. This systematic review assessed the effectiveness and reporting of external validity components in prevention interventions. The search was limited to randomized controlled trial (RCT) lifestyle interventions for the prevention of weight gain in young adults (18-35 years). Mean body weight and/or body mass index (BMI) change were the primary outcomes. External validity, quality assessment and risk of bias tools were applied to all studies. Twenty-one RCTs were identified through 14 major electronic databases. Over half of the studies were effective in the short term for significantly reducing body weight and/or BMI; however, few showed long-term maintenance. All studies lacked full reporting on external validity components. Description of the intervention components and participant attrition rates were reported by most studies. However, few studies reported the representativeness of participants, effectiveness of recruitment methods, process evaluation detail or costs. It is unclear from the information reported how to implement the interventions into community practice. Integrated reporting of intervention effectiveness and enhanced reporting of external validity components are needed for the translation and potential upscale of prevention strategies. © 2014 World Obesity.

A systematic review of studies evaluating diffusion and dissemination of selected cancer control interventions.

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Ellis, Peter; Robinson, Paula; Ciliska, Donna; Armour, Tanya; Brouwers, Melissa; O'Brien, Mary Ann; Sussman, Jonathan; Raina, Parminder

2005-09-01

With this review, the authors sought to determine what strategies have been evaluated (including the outcomes assessed) to disseminate cancer control interventions that promote the uptake of behavior change. Five topic areas along the cancer care continuum (smoking cessation, healthy diet, mammography, cervical cancer screening, and control of cancer pain) were selected to be representative. A systematic review was conducted of primary studies evaluating dissemination of a cancer control intervention. Thirty-one studies were identified that evaluated dissemination strategies in the 5 topic areas. No strong evidence currently exists to recommend any one dissemination strategy as effective in promoting the uptake of cancer control interventions. The authors conclude that there is a strong need for more research into dissemination of cancer control interventions. Future research should consider methodological issues such as the most appropriate study design and outcomes to be evaluated. (c) 2005 APA, all rights reserved

Interventions for replacing missing teeth: Antibiotics in dental implant placement to prevent complications: Evidence summary of Cochrane review.

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Jayaraman, Srinivasan

2015-01-01

The failure of dental implant can occurs at the preoperative planning stage, at the surgical stage, and at the postoperative stage. The success of this treatment can be increased if the clinical implant practice guidelines are prepared based on the recommendations from the highest level of research evidence (i.e.,) from systematic review of randomized controlled trials (RCTs) with meta-analysis. The Cochrane reviews of interventions are basically systematic reviews of RCTs with meta-analysis but follow a systematic methodological approach following the guidelines from Cochrane handbook for Systematic Reviews of Intervention. They give the current best evidence as they are updated every 2 years which is being the minimum period for an update. This evidence summary recommends the use of antibiotics, single dose of 2 g of amoxicillin 1 h prior to implant surgery to prevent implant failure, based on the body of evidence from the Cochrane review that was first published in 2003, 2008, and then updated twice in 2010 and 2013. The included studies are not from our population for the research question asked in this updated Cochrane review; hence, the need to do primary research in our population to support the available evidence is mandatory.

Psychological interventions for parents of children and adolescents with chronic illness.

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Eccleston, Christopher; Palermo, Tonya M; Fisher, Emma; Law, Emily

2012-08-15

Psychological therapies have been developed for parents of children and adolescents with a chronic illness. Such therapies include parent only or parent and child/adolescent, and are designed to treat parent behaviour, parent mental health, child behaviour/disability, child mental health, child symptoms and/or family functioning. No comprehensive, meta-analytic reviews have been published in this area. To evaluate the effectiveness of psychological therapies that include coping strategies for parents of children/adolescents with chronic illnesses (painful conditions, cancer, diabetes mellitus, asthma, traumatic brain injury, inflammatory bowel diseases, skin diseases or gynaecological disorders). The therapy will aim to improve parent behaviour, parent mental health, child behaviour/disability, child mental health, child symptoms and family functioning. We searched CENTRAL, MEDLINE, EMBASE and PsycINFO for randomised controlled trials (RCTs) of psychological interventions that included parents of children and adolescents with a chronic illness. The initial search was from inception of these databases to June 2011 and we conducted a follow-up search from June 2011 to March 2012. We identified additional studies from the reference list of retrieved papers and from discussion with investigators. Included studies were RCTs of psychological interventions that delivered treatment to parents of children and adolescents (under 19 years of age) with a chronic illness compared to active control, wait list control or treatment as usual. We excluded studies if the parent component was a coaching intervention, the aim of the intervention was health prevention/promotion, the comparator was a pharmacological treatment, the child/adolescent had an illness not listed above or the study included children with more than one type of chronic illness. Further to this, we excluded studies when the sample size of either comparator group was fewer than 10 at post-treatment. We included 35

Do palliative care interventions reduce emergency department visits among patients with cancer at the end of life? A systematic review.

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DiMartino, Lisa D; Weiner, Bryan J; Mayer, Deborah K; Jackson, George L; Biddle, Andrea K

2014-12-01

Frequent emergency department (ED) visits are an indicator of poor quality of cancer care. Coordination of care through the use of palliative care teams may limit aggressive care and improve outcomes for patients with cancer at the end of life. To systematically review the literature to determine whether palliative care interventions implemented in the hospital, home, or outpatient clinic are more effective than usual care in reducing ED visits among patients with cancer at the end of life. PubMed, EMBASE, and CINAHL databases were searched from database inception to May 7, 2014. Only randomized/non-randomized controlled trials (RCTs) and observational studies examining the effect of palliative care interventions on ED visits among adult patients with cancer with advanced disease were considered. Data were abstracted from the articles that met all the inclusion criteria. A second reviewer independently abstracted data from 2 articles and discrepancies were resolved. From 464 abstracts, 2 RCTs, 10 observational studies, and 1 non-RCT/quasi-experimental study were included. Overall there is limited evidence to support the use of palliative care interventions to reduce ED visits, although studies examining effect of hospice care and those conducted outside of the United States reported a statistically significant reduction in ED visits. Evidence regarding whether palliative care interventions implemented in the hospital, home or outpatient clinic are more effective than usual care at reducing ED visits is not strongly substantiated based on the literature reviewed. Improvements in the quality of reporting for studies examining the effect of palliative care interventions on ED use are needed.

Non-pharmacological interventions for reducing aggression and violence in serious mental illness: A systematic review and narrative synthesis.

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Rampling, J; Furtado, V; Winsper, C; Marwaha, S; Lucca, G; Livanou, M; Singh, S P

2016-04-01

For people with mental illness that are violent, a range of interventions have been adopted with the aim of reducing violence outcomes. Many of these interventions have been borrowed from other (offender) populations and their evidence base in a Serious Mental Illness (SMI) population is uncertain. To aggregate the evidence base for non-pharmacological interventions in reducing violence amongst adults with SMI and PD (Personality Disorder), and to assess the efficacy of these interventions. We chose to focus on distinct interventions rather than on holistic service models where any element responsible for therapeutic change would be difficult to isolate. We performed a systematic review and narrative synthesis of non-pharmacological interventions intended to reduce violence in a SMI population and in patients with a primary diagnosis of PD. Five online databases were searched alongside a manual search of seven relevant journals, and expert opinion was sourced. Eligibility of all returned articles was independently assessed by two authors, and quality of studies was appraised via the Cochrane Collaboration Tool for Assessing Risk of Bias. We included 23 studies of diverse psychological and practical interventions, with a range of experimental and quasi-experimental study designs that included 7 Randomised Controlled Trials (RCTs). The majority were studies of Mentally Disordered Offenders. The stronger evidence existed for patients with a SMI diagnosis receiving Cognitive Behavioural Therapy or modified Reasoning & Rehabilitation (R&R). For patients with a primary diagnosis of PD, a modified version of R&R appeared tolerable and Enhanced Thinking Skills showed some promise in improving attitudes over the short-term, but studies of Dialectical Behaviour Therapy in this population were compromised by high risk of experimental bias. Little evidence could be found for non-pharmacological, non-psychological interventions. The evidence for non

A multistage controlled intervention to increase stair climbing at work: effectiveness and process evaluation.

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Bellicha, Alice; Kieusseian, Aurélie; Fontvieille, Anne-Marie; Tataranni, Antonio; Copin, Nane; Charreire, Hélène; Oppert, Jean-Michel

2016-04-11

Stair climbing helps to accumulate short bouts of physical activity throughout the day as a strategy for attaining recommended physical activity levels. There exists a need for effective long-term stair-climbing interventions that can be transferred to various worksite settings. The aims of this study were: 1) to evaluate short- and long-term effectiveness of a worksite stair-climbing intervention using an objective measurement of stair climbing and a controlled design; and 2) to perform a process evaluation of the intervention. We performed a controlled before-and-after study. The study was conducted in two corporate buildings of the same company located in Paris (France), between September, 2013 and September, 2014. The status of either "intervention site" or "control site" was assigned by the investigators. Participants were on-site employees (intervention site: n = 783; control site: n = 545 at baseline). Two one-month intervention phases using signs (intervention phase 1) and enhancement of stairwell aesthetics (intervention phase 2) were performed. The main outcome was the change in stair climbing, measured with automatic counters and expressed in absolute counts/day/100 employees and percent change compared to baseline. Qualitative outcomes were used to describe the intervention process. Stair climbing significantly increased at the intervention site (+18.7%) but decreased at the control site (-13.3%) during the second intervention phase (difference between sites: +4.6 counts/day/100 employees, p levels at the intervention site, but a significant difference between sites was found (intervention site vs. control site: +2.9 counts/day/100 employees, p level after the end of the study. This study shows a successful stair-climbing intervention at the worksite. The main barriers to adoption and implementation were related to location and visibility of posters. Process evaluation was useful in identifying these barriers throughout the study, and in

Heuristic Evaluation of Ehealth Interventions: Establishing Standards That Relate to the Therapeutic Process Perspective.

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Baumel, Amit; Muench, Fred

2016-01-13

In recent years, the number of available eHealth interventions aimed at treating behavioral and mental health challenges has been growing. From the perspective of health care providers, there is a need for eHealth interventions to be evaluated prior to clinical trials and for the limited resources allocated to empirical research to be invested in the most promising products. Following a literature review, a gap was found in the availability of eHealth interventions evaluation principles related to the patient experience of the therapeutic process. This paper introduces principles and concepts for the evaluation of eHealth interventions developed as a first step in a process to outline general evaluation guidelines that relate to the clinical context from health care providers' perspective. Our approach was to conduct a review of literature that relates to the examination of eHealth interventions. We identified the literature that was most relevant to our study and used it to define guidelines that relate to the clinical context. We then compiled a list of heuristics we found to be useful for the evaluation of eHealth intervention products' suitability for empirical examination. Four heuristics were identified with respect to the therapeutic process: (1) the product's ease of use (ie, usability), (2) the eHealth intervention's compatibility with the clinical setting, (3) the presence of tools that make it easier for the user to engage in therapeutic activities, and (4) the provision of a feasible therapeutic pathway to growth. We then used this set of heuristics to conduct a detailed examination of MyFitnessPal. This line of work could help to set the bar higher for product developers and to inform health care providers about preferred eHealth intervention designs.

Interventions for improving coverage of childhood immunisation in low- and middle-income countries.

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Oyo-Ita, Angela; Wiysonge, Charles S; Oringanje, Chioma; Nwachukwu, Chukwuemeka E; Oduwole, Olabisi; Meremikwu, Martin M

2016-07-10

Immunisation is a powerful public health strategy for improving child survival, not only by directly combating key diseases that kill children but also by providing a platform for other health services. However, each year millions of children worldwide, mostly from low- and middle-income countries (LMICs), do not receive the full series of vaccines on their national routine immunisation schedule. This is an update of the Cochrane review published in 2011 and focuses on interventions for improving childhood immunisation coverage in LMICs. To evaluate the effectiveness of intervention strategies to boost and sustain high childhood immunisation coverage in LMICs. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2016, Issue 4, part of The Cochrane Library. www.cochranelibrary.com, including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (searched 12 May 2016); MEDLINE In-Process and Other Non-Indexed Citations, MEDLINE Daily and MEDLINE 1946 to Present, OvidSP (searched 12 May 2016); CINAHL 1981 to present, EbscoHost (searched 12 May 2016); Embase 1980 to 2014 Week 34, OvidSP (searched 2 September 2014); LILACS, VHL (searched 2 September 2014); Sociological Abstracts 1952 - current, ProQuest (searched 2 September 2014). We did a citation search for all included studies in Science Citation Index and Social Sciences Citation Index, 1975 to present; Emerging Sources Citation Index 2015 to present, ISI Web of Science (searched 2 July 2016). We also searched the two Trials Registries: ICTRP and ClinicalTrials.gov (searched 5 July 2016) SELECTION CRITERIA: Eligible studies were randomised controlled trials (RCT), non-RCTs, controlled before-after studies, and interrupted time series conducted in LMICs involving children aged from birth to four years, caregivers, and healthcare providers. We independently screened the search output, reviewed full texts of potentially eligible articles, assessed risk of bias

Failure To Thrive: Strategies for Evaluation and Intervention.

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Black, Maureen M.

1995-01-01

Reviews the definition of failure to thrive (FTT) and its relationship to theories of child development as FTT is an early physical marker of risk with long-term consequences. These children are often eligible for services through PL99-457, and psychologists can play an integral role in multidisciplinary evaluation and on intervention team.…

Effect of Expressive Writing Intervention on Health Outcomes in Breast Cancer Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

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Chunlan Zhou

Full Text Available Numerous randomized controlled trials (RCTs have arrived at conflicting conclusions on expressive writing (EW as an intervention for breast cancer (BC patients, but there has been no meta-analysis of these studies to assess the effectiveness of EW in BC population.PubMed, Web of Science, The Cochrane Library, EMBASE, and CINAHL and the www.clinicaltrial.gov database on ongoing clinical trials were searched to identify all the RCTs investigating efficacy of EW on the physical and psychological health in BC patients. The risk of bias of the original studies was assessed using the Cochrane Collaboration's tool. Our primary outcomes for physical and psychological health were respectively negative somatic symptoms and negative mood which were stratified by emotional, benefit-finding and multiple prompts in sub-group analyses. The data were analyzed using Review Manager 5.2 and Stata version 12.0 statistical software.Of the 5,232 titles screened, we identified 11 RCTs with a total of 1,178 participants. The pooled results showed a significant effect of EW using either an emotional prompt or a benefit-finding prompt on reducing negative somatic symptoms in BC patients in the ≤3-month follow-up group [Mean Difference (MD, -13.03, 95% CI, -19.23 to -6.83, P3-month follow-up group. There were no significant differences regarding psychological health indexes between EW intervention and control groups at any of the follow-up time-points (P>0.05.This systematic review and meta-analysis reveals that EW intervention may have a significantly positive impact on the physical health but not the psychological health in BC patients, but this benefit may not last long. However, further high-quality studies with more homogeneity are needed to confirm the current findings.

Explaining feast or famine in randomized field trials. Medical science and criminology compared.

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Shepherd, Jonathan P

2003-06-01

A feast of randomized controlled trials (RCTs) in medical science and comparative famine in criminology can be explained in terms of cultural and structural factors. Of central importance is the context in which the evaluation of interventions is done and the difference in status of situational research in the two disciplines. Evaluation of medical interventions has traditionally been led by practitioner (clinical) academics. This is not the case in criminal justice, where theory has had higher status than intervention research. Medical science has advanced in, or closely associated with, university teaching hospitals, but links between criminology and criminal justice services are far more tenuous. The late development of situational crime prevention seems extraordinary from a medical perspective, as does the absence of university police schools in the United Kingdom and elsewhere. These structural and cultural factors explain concentration of expectation, resource, and RCT productivity in medical science. The Campbell Collaboration and the Academy of Experimental Criminology are forces which are reducing this polarization of feast and famine in RCTs. But unless scientific criminology is embedded in university schools which are responsible for the education and training of law, probation, and police practitioners, convergence in terms of RCTs and implementation of findings in practice seems unlikely.

Adding Qualitative and Mixed Methods Research to Health Intervention Studies: Interacting With Differences.

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Johnson, R Burke; Schoonenboom, Judith

2016-04-01

The purpose of this article is to explain how to improve intervention designs, such as randomized controlled trials (RCTs), in health science research using a process philosophy and theory known as dialectical pluralism (DP). DP views reality as plural and uses dialectical, dialogical, and hermeneutical approaches to knowledge construction. Using DP and its "both/and" logic, and its attempt to produce new creative syntheses, researchers on heterogeneous teams can better dialogue with qualitative and mixed methods approaches, concepts, paradigms, methodologies, and methods to improve their intervention research studies. The concept of reflexivity is utilized but is expanded when it is a component of DP. Examples of strategies for identifying, inviting, and creating divergence and integrative strategies for producing strong mixed methods intervention studies are provided and illustrated using real-life examples. © The Author(s) 2015.

Community-led trials: Intervention co-design in a cluster randomised controlled trial.

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Andersson, Neil

2017-05-30

In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

Community-led trials: Intervention co-design in a cluster randomised controlled trial

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Neil Andersson

2017-05-01

Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

Nutritional interventions for survivors of childhood cancer.

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Cohen, Jennifer E; Wakefield, Claire E; Cohn, Richard J

2016-08-22

2012). We included all randomised controlled trials (RCTs) that compared the effects of a nutritional intervention with a control group which did not receive the intervention in this review. Participants were childhood cancer survivors of any age, diagnosed with any type of cancer when less than 18 years of age. Participating childhood cancer survivors had completed their treatment with curative intent prior to the intervention. Two review authors independently selected and extracted data from each identified study, using a standardised form. We assessed the validity of each identified study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We used the GRADE criteria to assess the quality of each trial. Three RCTs were eligible for review. A total of 616 participants were included in the analysis. One study included participants who had been treated for acute lymphoblastic leukaemia (ALL) (275 participants). Two studies included participants who had all forms of paediatric malignancies (266 and 75 participants). All participants were less than 21 years of age at study entry. The follow-up ranged from one month to 36 months from the initial assessment. All intended outcomes were not evaluated by each included study. All studies looked at different interventions, and so we were unable to pool results. We could not rule out the presence of bias in any of the studies.There was no clear evidence of a difference in calcium intake at one month between those who received the single, half-day, group-based education that focused on bone health, and those who received standard care (mean difference (MD) 111.60, 95% confidence interval (CI) -258.97 to 482.17; P = 0.56, low quality evidence). A regression analysis, adjusting for baseline calcium intake and changes in knowledge and self-efficacy, showed a significantly greater calcium intake for the intervention as compared with the control group at the one-month follow-up (beta

Reproductive health services in Malawi: an evaluation of a quality improvement intervention.

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Rawlins, Barbara J; Kim, Young-Mi; Rozario, Aleisha M; Bazant, Eva; Rashidi, Tambudzai; Bandazi, Sheila N; Kachale, Fannie; Sanghvi, Harshad; Noh, Jin Won

2013-01-01

this study was to evaluate the impact of a quality improvement initiative in Malawi on reproductive health service quality and related outcomes. (1) post-only quasi-experimental design comparing observed service quality at intervention and comparison health facilities, and (2) a time-series analysis of service statistics. sixteen of Malawi's 23 district hospitals, half of which had implemented the Performance and Quality Improvement (PQI) intervention for reproductive health at the time of the study. a total of 98 reproductive health-care providers (mostly nurse-midwives) and 139 patients seeking family planning (FP), antenatal care (ANC), labour and delivery (L&D), or postnatal care (PNC) services. health facility teams implemented a performance and quality improvement (PQI) intervention over a 3-year period. Following an external observational assessment of service quality at baseline, facility teams analysed performance gaps, designed and implemented interventions to address weaknesses, and conducted quarterly internal assessments to assess progress. Facilities qualified for national recognition by complying with at least 80% of reproductive health clinical standards during an external verification assessment. key measures include facility readiness to provide quality care, observed health-care provider adherence to clinical performance standards during service delivery, and trends in service utilisation. intervention facilities were more likely than comparison facilities to have the needed infrastructure, equipment, supplies, and systems in place to offer reproductive health services. Observed quality of care was significantly higher at intervention than comparison facilities for PNC and FP. Compared with other providers, those at intervention facilities scored significantly higher on client assessment and diagnosis in three service areas, on clinical management and procedures in two service areas, and on counselling in one service area. Service statistics

Characteristics of randomized trials published in Latin America and the Caribbean according to funding source.

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Ludovic Reveiz

Full Text Available INTRODUCTION: Few studies have assessed the nature and quality of randomized controlled trials (RCTs in Latin America and the Caribbean (LAC. METHODS AND FINDINGS: The aims of this systematic review are to evaluate the characteristics (including the risk of bias assessment of RCT conducted in LAC according to funding source. A review of RCTs published in 2010 in which the author's affiliation was from LAC was performed in PubMed and LILACS. Two reviewers independently extracted data and assessed the risk of bias. The primary outcomes were risk of bias assessment and funding source. A total of 1,695 references were found in PubMed and LILACS databases, of which 526 were RCTs (N = 73.513 participants. English was the dominant publication language (93% and most of the RCTs were published in non-LAC journals (84.2%. Only five of the 19 identified countries accounted for nearly 95% of all RCTs conducted in the region (Brazil 70.9%, Mexico 10.1%, Argentina 5.9%, Colombia 3.8%, and Chile 3.4%. Few RCTs covered priority areas related with Millennium Development Goals like maternal health (6.7% or high priority infectious diseases (3.8%. Regarding children, 3.6% and 0.4% RCT evaluated nutrition and diarrhea interventions respectively but none pneumonia. As a comparison, aesthetic and sport related interventions account for 4.6% of all trials. A random sample of RCTs (n = 358 was assessed for funding source: exclusively public (33.8%; private (e.g. pharmaceutical company (15.3%; other (e.g. mixed, NGO (15.1%; no funding (35.8%. Overall assessments for risk of bias showed no statistically significant differences between RCTs and type of funding source. Statistically significant differences favoring private and others type of funding was found when assessing trial registration and conflict of interest reporting. CONCLUSION: Findings of this study could be used to provide more direction for future research to facilitate innovation, improve health

Characteristics of randomized trials published in Latin America and the Caribbean according to funding source.

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Reveiz, Ludovic; Sangalang, Stephanie; Glujovsky, Demian; Pinzon, Carlos E; Asenjo Lobos, Claudia; Cortes, Marcela; Cañón, Martin; Bardach, Ariel; Bonfill, Xavier

2013-01-01

Few studies have assessed the nature and quality of randomized controlled trials (RCTs) in Latin America and the Caribbean (LAC). The aims of this systematic review are to evaluate the characteristics (including the risk of bias assessment) of RCT conducted in LAC according to funding source. A review of RCTs published in 2010 in which the author's affiliation was from LAC was performed in PubMed and LILACS. Two reviewers independently extracted data and assessed the risk of bias. The primary outcomes were risk of bias assessment and funding source. A total of 1,695 references were found in PubMed and LILACS databases, of which 526 were RCTs (N = 73.513 participants). English was the dominant publication language (93%) and most of the RCTs were published in non-LAC journals (84.2%). Only five of the 19 identified countries accounted for nearly 95% of all RCTs conducted in the region (Brazil 70.9%, Mexico 10.1%, Argentina 5.9%, Colombia 3.8%, and Chile 3.4%). Few RCTs covered priority areas related with Millennium Development Goals like maternal health (6.7%) or high priority infectious diseases (3.8%). Regarding children, 3.6% and 0.4% RCT evaluated nutrition and diarrhea interventions respectively but none pneumonia. As a comparison, aesthetic and sport related interventions account for 4.6% of all trials. A random sample of RCTs (n = 358) was assessed for funding source: exclusively public (33.8%); private (e.g. pharmaceutical company) (15.3%); other (e.g. mixed, NGO) (15.1%); no funding (35.8%). Overall assessments for risk of bias showed no statistically significant differences between RCTs and type of funding source. Statistically significant differences favoring private and others type of funding was found when assessing trial registration and conflict of interest reporting. Findings of this study could be used to provide more direction for future research to facilitate innovation, improve health outcomes or address priority health problems.

A pragmatic cluster randomised trial evaluating three implementation interventions

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Rycroft-Malone Jo

2012-08-01

Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

Interventions to Improve the Response of Professionals to Children Exposed to Domestic Violence and Abuse: A Systematic Review.

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Turner, William; Hester, Marianne; Broad, Jonathan; Szilassy, Eszter; Feder, Gene; Drinkwater, Jessica; Firth, Adam; Stanley, Nicky

2017-01-01

Exposure of children to domestic violence and abuse (DVA) is a form of child maltreatment with short- and long-term behavioural and mental health impact. Health care professionals are generally uncertain about how to respond to domestic violence and are particularly unclear about best practice with regards to children's exposure and their role in a multiagency response. In this systematic review, we report educational and structural or whole-system interventions that aim to improve professionals' understanding of, and response to, DVA survivors and their children. We searched 22 bibliographic databases and contacted topic experts for studies reporting quantitative outcomes for any type of intervention aiming to improve professional responses to disclosure of DVA with child involvement. We included interventions for physicians, nurses, social workers and teachers. Twenty-one studies met the inclusion criteria: three randomised controlled trials (RCTs), 18 pre-post intervention surveys. There were 18 training and three system-level interventions. Training interventions generally had positive effects on participants' knowledge, attitudes towards DVA and clinical competence. The results from the RCTs were consistent with the before-after surveys. Results from system-level interventions aimed to change organisational practice and inter-organisational collaboration demonstrates the benefit of coordinating system change in child welfare agencies with primary health care and other organisations. Implications for policy and research are discussed. © 2015 The Authors. Child Abuse Review published by John Wiley & Sons Ltd. 'We searched 22 bibliographic databases and contacted topic experts'. We reviewed published evidence on interventions aimed at improving professionals' practice with domestic violence survivors and their children.Training programmes were found to improve participants' knowledge, attitudes and clinical competence up to a year after delivery.Key elements of

Normalisation process theory: a framework for developing, evaluating and implementing complex interventions

LENUS (Irish Health Repository)

Murray, Elizabeth

2010-10-20

Abstract Background The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation). Discussion In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential. Summary The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.

Normalisation process theory: a framework for developing, evaluating and implementing complex interventions

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Ong Bie

2010-10-01

Full Text Available Abstract Background The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation. Discussion In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential. Summary The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.

Evaluation of a Sibling-Mediated Imitation Intervention for Young Children with Autism

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Walton, Katherine M.; Ingersoll, Brooke R.

2012-01-01

Parents and peers have been successful at implementing interventions targeting social interactions in children with autism; however, few interventions have trained siblings as treatment providers. This study used a multiple-baseline design across six sibling dyads (four children with autism) to evaluate the efficacy of sibling-implemented…

Methods for evaluating a mature substance abuse prevention/early intervention program.

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Becker, L R; Hall, M; Fisher, D A; Miller, T R

2000-05-01

The authors describe methods for work in progress to evaluate four workplace prevention and/or early intervention programs designed to change occupational norms and reduce substance abuse at a major U.S. transportation company. The four programs are an employee assistance program, random drug testing, managed behavioral health care, and a peer-led intervention program. An elaborate mixed-methods evaluation combines data collection and analysis techniques from several traditions. A process-improvement evaluation focuses on the peer-led component to describe its evolution, document the implementation process for those interested in replicating it, and provide information for program improvement. An outcome-assessment evaluation examines impacts of the four programs on job performance measures (e.g., absenteeism, turnover, injury, and disability rates) and includes a cost-offset and employer cost-savings analysis. Issues related to using archival data, combining qualitative and quantitative designs, and working in a corporate environment are discussed.

Problem-based learning interventions in a traditional curriculum are an effective learning tool.

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Townsend, Grant

2011-12-01

PubMed, ERIC and PsycLIT. The database search was supplemented with manual search of the electronic archives of the following journals: Academic Medicine, Medical Education, Teaching and Learning in Medicine, Journal of Dental Education and European Journal of Dental Education. Further articles were retrieved from the reference lists of selected papers. The review covered the period 1976-2008. Studies were eligible if they presented original research using PBL in research settings compared with another educational method (at a whole curriculum level or as a single intervention). This review included both randomised controlled trials (RCTs) and comparative studies. Qualitative and quantitative designs were eligible. Three dental educators selected studies. It is not clear that there were predefined criteria. The studies showed considerable heterogeneity in their study designs, characteristics, outcome variables and results. A descriptive review of the data was presented. Sixty-nine studies were initially identified. The authors excluded 17 of these because they could not obtain full texts. Thirteen studies were excluded because they used purely qualitative data. Of the remaining 39 studies six were RCTs and 33 comparative studies. The RCTs gave little information about the curriculum design and used markedly different outcome measurements including test scores, personal characteristics and subjective approaches to learning and experiences. There was no overall difference in student performances between the integrated and the PBL curriculum but a significant difference in favour of these two when compared with a conventional curriculum. A modest advantage of PBL was noted in relational skills, humanistic attitudes and diagnostic accuracy. Test scores did not appear to be influenced by the use of PBL. Though PBL seems to have a good effect on several competencies after graduation no significant effects were observed in lifelong learning attitudes. Comparative studies

Intervention for replacing missing teeth: Different types of implants - evidence summary of updated Cochrane review

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Balendra Pratap Singh

2015-01-01

Full Text Available Around 1300 different types of dental implants are available worldwide and the implant manufacturers are resorting to aggressive marketing strategies; claiming their implants to provide a superior outcome. The clinician is left with a constant dilemma on which implant to choose for better clinical outcome and welfare of the patient. Moreover, in India, economical consideration is a concern too. The dentist has to select an implant that provides a good result and is economical. Cochrane systematic reviews provide the gold standard evidence for intervention, diagnosis, etc., and follow a strict quality control. A Cochrane systematic review was done to shed light on whether the different implant surface modifications, shapes or materials significantly influence clinical outcomes. All randomized controlled trials (RCTs till January 17, 2014 were searched and out of the 81 trials, only 27 met the inclusion criteria. This evidence summary from the review concludes that based on the available literature; there is no evidence of any one type of implant being superior to another. There is weak evidence showing roughened dental implants are more prone to bone loss due to periimplantitis. This review indicated that there is a need for well-designed RCTs, with long-term follow-up and low bias. Moreover, none of the included studies was from India, which also points out the need for improving the quality of RCTs conducted in India.

Difficulties in conducting a randomized controlled trial of health service interventions in intellectual disability: implications for evidence-based practice.

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Oliver, P C; Piachaud, J; Done, J; Regan, A; Cooray, S; Tyrer, P

2002-05-01

In an era of evidence-based medicine, practice is constantly monitored for quality in accordance with the needs of clinical governance (Oyebode et al. 1999). This is likely to lead to a dramatic change in the treatment of those with intellectual disability (ID), in which evidence for effective intervention is limited for much that happens in ordinary practice. As Fraser (2000, p. 10) has commented, the word that best explains "the transformation of learning disability practice in the past 30 years is 'enlightenment'." This is not enough to satisfy the demands of evidence, and Fraser exhorted us to embrace more research-based practice in a subject that has previously escaped randomized controlled trials (RCTs) of treatment because of ethical concerns over capacity and consent, which constitute a denial of opportunity which "is now at last regarded as disenfranchising". The present paper describes the difficulties encountered in setting up a RCT of a common intervention, i.e. assertive community treatment, and concludes that a fundamental change in attitudes to health service research in ID is needed if proper evaluation is to prosper.

Randomized Controlled Trials of Technology-Based HIV/STI and Drug Abuse Preventive Interventions for African American and Hispanic Youth: Systematic Review.

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Córdova, David; Mendoza Lua, Frania; Ovadje, Lauretta; Hong, Ethan; Castillo, Berenice; Salas-Wright, Christopher P

2017-12-13

HIV/sexually transmitted infections (STIs) and drug abuse remain significant public health concerns in the United States, and African American and Hispanic youth are disproportionately affected. Although technology-based interventions are efficacious in preventing and reducing HIV/STI and licit/illicit drug use behaviors, relatively little is known regarding the state of the science of these interventions among African American and Hispanic youth. The aim of this review is to identify and examine randomized controlled trials (RCTs) of technology-based HIV/STI and/or drug abuse preventive interventions for African American and Hispanic youth. We searched electronic databases (ie, PubMed, Proquest, PsycINFO, Ebscohost, Google Scholar) to identify studies between January 2006 and October 2016. RCTs of technology-based interventions targeting African American and Hispanic youth HIV/STI risk behaviors, including sexual risk, licit and illicit drug use, and HIV/STI testing were included. Our search revealed a total of three studies that used an RCT design and included samples comprised of >50% African American and/or Hispanic youth. The follow-up assessments ranged from two weeks to six months and the number of participants in each trial ranged from 72 to 141. The three interventions were theory-driven, interactive, and tailored. The long-term effects of the interventions were mixed, and outcomes included reductions in sex partners, licit drug use, and condomless anal sex acts. Although technology-based interventions seem promising in the prevention of HIV/STI and drug abuse among African American and Hispanic youth, more research is needed. ©David Córdova, Frania Mendoza Lua, Lauretta Ovadje, Ethan Hong, Berenice Castillo, Christopher P Salas-Wright. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 13.12.2017.

Interventions for infantile haemangiomas of the skin.

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Novoa, Monica; Baselga, Eulalia; Beltran, Sandra; Giraldo, Lucia; Shahbaz, Ali; Pardo-Hernandez, Hector; Arevalo-Rodriguez, Ingrid

2018-04-18

topical timolol maleateWhen topical timolol maleate (0.5% eye drops applied twice daily) was compared with oral propranolol (via a tablet taken once per day, at a 1.0 mg/kg dose), there was no evidence of a difference in haemangioma size (as a measure of resolution) when measured by the proportion of patients with a clinician-assessed reduction of 50% or greater (RR 1.13, 95% CI 0.64 to 1.97; 1 study; 26 participants; low-quality evidence). Although there were more short- or long-term general adverse effects (such as severe diarrhoea, lethargy, and loss of appetite) in the oral propranolol group, there was no evidence of a difference between groups (RR 7.00, 95% CI 0.40 to 123.35; 1 study; 26 participants; very low-quality evidence). This comparison did not measure clearance.None of our key comparisons evaluated, at any follow-up, a subjective measure of improvement assessed by the parent or child; proportion of parents or children who consider there is still a problem; or physician-, child-, or parent-assessed aesthetic appearance. We found there to be a limited evidence base for the treatment of infantile haemangiomas: a large number of interventions and outcomes have not been assessed in RCTs.Our key results indicate that in the management of IH in children, oral propranolol and topical timolol maleate are more beneficial than placebo in terms of clearance or other measures of resolution, or both, without an increase in harms. We found no evidence of a difference between oral propranolol and topical timolol maleate with regard to reducing haemangioma size, but we are uncertain if there is a difference in safety. Oral propranolol is currently the standard treatment for this condition, and our review has not found evidence to challenge this. However, these results are based on moderate- to very low-quality evidence.The included studies were limited by small sample sizes and risk of bias in some domains. Future trials should blind personnel and participants; describe

Effects of Group Counseling Programs, Cognitive Behavioral Therapy, and Sports Intervention on Internet Addiction in East Asia: A Systematic Review and Meta-Analysis

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Jun Liu

2017-11-01

Full Text Available To evaluate the effects of group counseling programs, cognitive behavioral therapy (CBT, and sports intervention on Internet addiction (IA, a systematic search in ten databases was performed to identify eligible studies without language restrictions up to January 2017. A meta-analysis and trial sequential analysis (TSA was performed, respectively. A total of 58 randomized controlled trials (RCTs, which included 2871 participants, were incorporated into our meta-analysis. The results showed that group counseling programs, CBT, and sports intervention could significantly reduce IA levels (group counseling program: standardized mean difference (SMD, −1.37; 95% confidence interval (CI, −1.89 to −0.85; CBT: SMD, −1.88; 95% CI, −2.53 to −1.23; sports intervention: SMD, −1.70; 95% CI, −2.14 to −1.26. For group counseling programs, this treatment was more effective in four dimensions of IA, including time management, interpersonal and health issues, tolerance, and compulsive Internet use. For CBT, this treatment yielded a positive change in depression, anxiousness, aggressiveness, somatization, social insecurity, phobic anxiety, paranoid ideation, and psychoticism. For sports intervention, the significant effects were also observed in all dimensions of the IA scale. Each of group counseling programs, cognitive behavioral therapy, and sports intervention had a significant effect on IA and psychopathological symptoms. Sports intervention could improve withdrawal symptoms especially.

Brief Report: An Evaluation of an Australian Autism-Specific, Early Intervention Programme

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Paynter, Jessica M.; Riley, Emma P.; Beamish, Wendi; Scott, James G.; Heussler, Helen S.

2015-01-01

There is a relative paucity of evidence examining the effectiveness of early intervention for young children with Autism Spectrum Disorder, in particular those delivered through educationally-based programmes. This study aimed to evaluate the real world effectiveness of a community-based autism-specific early learning and intervention programme in…

Interventions to change the behaviour of health professionals and the organisation of care to promote weight reduction in overweight and obese adults

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Flodgren, Gerd; Deane, Katherine; Dickinson, Heather O; Kirk, Sara; Alberti, Hugh; Beyer, Fiona R; Brown, James G; Penney, Tarra L; Summerbell, Carolyn D; Eccles, Martin P

2014-01-01

Background The prevalence of obesity is increasing globally and will, if left unchecked, have major implications for both population health and costs to health services. Objectives To assess the effectiveness of strategies to change the behaviour of health professionals and the organisation of care to promote weight reduction in overweight and obese people. Search methods We updated the search for primary studies in the following databases, which were all interrogated from the previous (version 2) search date to May 2009: The Cochrane Central Register of Controlled Trials (which at this time incorporated all EPOC Specialised Register material) (The Cochrane Library 2009, Issue 1), MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO), and PsycINFO (Ovid). We identified further potentially relevant studies from the reference lists of included studies. Selection criteria Randomised controlled trials (RCTs) that compared routine provision of care with interventions aimed either at changing the behaviour of healthcare professionals or the organisation of care to promote weight reduction in overweight or obese adults. Data collection and analysis Two reviewers independently extracted data and assessed study quality. Main results We included six RCTs, involving more than 246 health professionals and 1324 overweight or obese patients. Four of the trials targeted professionals and two targeted the organisation of care. Most of the studies had methodological or reporting weaknesses indicating a risk of bias. Meta-analysis of three trials that evaluated educational interventions aimed at GPs suggested that, compared to standard care, such interventions could reduce the average weight of patients after a year (by 1.2 kg, 95% CI −0.4 to 2.8 kg); however, there was moderate unexplained heterogeneity between their results (I2 = 41%). One trial found that reminders could change doctors’ practice, resulting in a significant reduction in weight among men (by 11.2 kg, 95% CI 1.7 to 20

Interventions for actinic keratoses.

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Gupta, Aditya K; Paquet, Maryse; Villanueva, Elmer; Brintnell, William

2012-12-12

Actinic keratoses are a skin disease caused by long-term sun exposure, and their lesions have the potential to develop into squamous cell carcinoma. Treatments for actinic keratoses are sought for cosmetic reasons, for the relief of associated symptoms, or for the prevention of skin cancer development. Detectable lesions are often associated with alteration of the surrounding skin (field) where subclinical lesions might be present. The interventions available for the treatment of actinic keratoses include individual lesion-based (e.g. cryotherapy) or field-directed (e.g. topical) treatments. These might vary in terms of efficacy, safety, and cosmetic outcomes. To assess the effects of topical, oral, mechanical, and chemical interventions for actinic keratosis. We searched the following databases up to March 2011: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 2005), EMBASE (from 2010), and LILACS (from 1982). We also searched trials registers, conference proceedings, and grey literature sources. Randomised controlled trials (RCTs) comparing the treatment of actinic keratoses with either placebo, vehicle, or another active therapy. At least two authors independently abstracted data, which included adverse events, and assessed the quality of evidence. We performed meta-analysis to calculate a weighted treatment effect across trials, and we expressed the results as risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes (e.g. participant complete clearance rates), and mean difference (MD) and 95% CI for continuous outcomes (e.g. mean reduction in lesion counts). We included 83 RCTs in this review, with a total of 10,036 participants. The RCTs covered 18 topical treatments, 1 oral treatment, 2 mechanical interventions, and 3 chemical interventions, including photodynamic therapy (PDT). Most of the studies lacked descriptions of some methodological details, such as the generation of the randomisation

A Youth Suicide Prevention Plan for Canada: A Systematic Review of Reviews.

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Bennett, Kathryn; Rhodes, Anne E; Duda, Stephanie; Cheung, Amy H; Manassis, Katharina; Links, Paul; Mushquash, Christopher; Braunberger, Peter; Newton, Amanda S; Kutcher, Stanley; Bridge, Jeffrey A; Santos, Robert G; Manion, Ian G; Mclennan, John D; Bagnell, Alexa; Lipman, Ellen; Rice, Maureen; Szatmari, Peter

2015-06-01

We conducted an expedited knowledge synthesis (EKS) to facilitate evidence-informed decision making concerning youth suicide prevention, specifically school-based strategies and nonschool-based interventions designed to prevent repeat attempts. Systematic review of review methods were applied. Inclusion criteria were as follows: systematic review or meta-analysis; prevention in youth 0 to 24 years; peer-reviewed English literature. Review quality was determined with AMSTAR (a measurement tool to assess systematic reviews). Nominal group methods quantified consensus on recommendations derived from the findings. No included review addressing school-based prevention (n = 7) reported decreased suicide death rates based on randomized controlled trials (RCTs) or controlled cohort studies (CCSs), but reduced suicide attempts, suicidal ideation, and proxy measures of suicide risk were reported (based on RCTs and CCSs). Included reviews addressing prevention of repeat suicide attempts (n = 14) found the following: emergency department transition programs may reduce suicide deaths, hospitalizations, and treatment nonadherence (based on RCTs and CCSs); training primary care providers in depression treatment may reduce repeated attempts (based on one RCT); antidepressants may increase short-term suicide risk in some patients (based on RCTs and meta-analyses); this increase is offset by overall population-based reductions in suicide associated with antidepressant treatment of youth depression (based on observational studies); and prevention with psychosocial interventions requires further evaluation. No review addressed sex or gender differences systematically, Aboriginal youth as a special population, harm, or cost-effectiveness. Consensus on 6 recommendations ranged from 73% to 100%. Our EKS facilitates decision maker access to what is known about effective youth suicide prevention interventions. A national research-to-practice network that links researchers and decision

Evaluation of a school-based intervention programme for South ...

African Journals Online (AJOL)

Objective: Parental divorce affects approximately 30 000 South African children annually. This pilot study aimed to evaluate the effectiveness of the Children of Divorce Intervention Programme (CODIP) at two South African schools. CODIP is a preventively oriented group programme which was developed to foster resilience ...

Evaluating Complex Healthcare Systems: A Critique of Four Approaches

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Heather Boon

2007-01-01

Full Text Available The purpose of this paper is to bring clarity to the emerging conceptual and methodological literature that focuses on understanding and evaluating complex or ‘whole’ systems of healthcare. An international working group reviewed literature from interdisciplinary or interprofessional groups describing approaches to the evaluation of complex systems of healthcare. The following four key approaches were identified: a framework from the MRC (UK, whole systems research, whole medical systems research described by NCCAM (USA and a model from NAFKAM (Norway. Main areas of congruence include acknowledgment of the inherent complexity of many healthcare interventions and the need to find new ways to evaluate these; the need to describe and understand the components of complex interventions in context (as they are actually practiced; the necessity of using mixed methods including randomized clinical trials (RCTs (explanatory and pragmatic and qualitative approaches; the perceived benefits of a multidisciplinary team approach to research; and the understanding that methodological developments in this field can be applied to both complementary and alternative medicine (CAM as well as conventional therapies. In contrast, the approaches differ in the following ways: terminology used, the extent to which the approach attempts to be applicable to both CAM and conventional medical interventions; the prioritization of research questions (in order of what should be done first especially with respect to how the ‘definitive’ RCT fits into the process of assessing complex healthcare systems; and the need for a staged approach. There appears to be a growing international understanding of the need for a new perspective on assessing complex healthcare systems.

Commercial off-the-shelf consumer health informatics interventions: recommendations for their design, evaluation and redesign.

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Marquard, Jenna L; Zayas-Cabán, Teresa

2012-01-01

The goal of this paper is to describe the successful application of a use case-based evaluation approach to guide the effective design, evaluation and redesign of inexpensive, commercial, off-the-shelf consumer health informatics (CHI) interventions. Researchers developed four CHI intervention use cases representing two distinct patient populations (patients with diabetes with high blood pressure, post-bariatric surgery patients), two commercial off-the-shelf CHI applications (Microsoft HealthVault, Google Health), and related devices (blood pressure monitor, pedometer, weight scale). Three patient proxies tested each intervention for 10 days. The patient proxies recorded their challenges while completing use case tasks, rating the severity of each challenge based on how much it hindered their use of the intervention. Two independent evaluators categorized the challenges by human factors domain (physical, cognitive, macroergonomic). The use case-based approach resulted in the identification of 122 challenges, with 12% physical, 50% cognitive and 38% macroergonomic. Thirty-nine challenges (32%) were at least moderately severe. Nine of 22 use case tasks (41%) accounted for 72% of the challenges. The study used two patient proxies and addressed two specific patient populations and low-cost, off-the-shelf CHI interventions, which may not perfectly generalize to a larger number of proxies, actual patient populations, or other CHI interventions. CHI designers can employ the use case-based evaluation approach to assess the fit of a CHI intervention with patients' health work, in the context of their daily activities and environment, which would be difficult or impossible to evaluate by laboratory-based studies.

Health promotion interventions for community-dwelling older people with mild or pre-frailty: a systematic review and meta-analysis.

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Frost, Rachael; Belk, Celia; Jovicic, Ana; Ricciardi, Federico; Kharicha, Kalpa; Gardner, Benjamin; Iliffe, Steve; Goodman, Claire; Manthorpe, Jill; Drennan, Vari M; Walters, Kate

2017-07-20

Mild or pre-frailty is common and associated with increased risks of hospitalisation, functional decline, moves to long-term care, and death. Little is known about the effectiveness of health promotion in reducing these risks. This systematic review aimed to synthesise randomised controlled trials (RCTs) evaluating home and community-based health promotion interventions for older people with mild/pre-frailty. We searched 20 bibliographic databases and 3 trials registers (January 1990 - May 2016) using mild/pre-frailty and associated terms. We included randomised controlled and crossover trials of health promotion interventions for community-dwelling older people (65+ years) with mild/pre-frailty and excluded studies focussing on populations in hospital, long term care facilities or with a specific condition. Risk of bias was assessed by two reviewers using the Cochrane Risk of Bias tool. We pooled study results using standardised mean differences (SMD) where possible and used narrative synthesis where insufficient outcome data were available. We included 10 articles reporting on seven trials (total n = 506 participants) and included five trials in a meta-analysis. Studies were predominantly small, of limited quality and six studies tested group exercise alone. One study additionally investigated a nutrition and exercise intervention and one evaluated telemonitoring. Interventions of exercise in groups showed mixed effects on functioning (no effects on self-reported functioning SMD 0.19 (95% CI -0.57 to 0.95) n = 3 studies; positive effects on performance-based functioning SMD 0.37 (95% CI 0.07 to 0.68) n = 3 studies). No studies assessed moves to long-term care or hospitalisations. Currently the evidence base is of insufficient size, quality and breadth to recommend specific health promotion interventions for older people with mild or pre- frailty. High quality studies of rigorously developed interventions are needed. CRD42014010370 (Review 2).

Yogurt for treating antibiotic-associated diarrhea: Systematic review and meta-analysis.

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Patro-Golab, Bernadeta; Shamir, Raanan; Szajewska, Hania

2015-06-01

Antibiotic-associated diarrhea (AAD) is a common complication in individuals treated with antibiotics. The aim of this review was to systematically evaluate the efficacy of yogurt consumption for the prevention of AAD. In this systematic review, a number of databases including MEDLINE, EMBASE, and the Cochrane Library, with no language restrictions, were searched up to September 2014 for randomized controlled trials (RCTs) evaluating the effect of yogurt consumption in adults and children who were receiving antibiotics. The risk for bias was assessed using the Cochrane risk of bias tool. Two RCTs, both low in methodological quality, were included. Compared with no intervention, yogurt consumption reduced the risk for diarrhea in the fixed effect model (two RCTs, n = 314, relative risk [RR], 0.56; 95% confidence interval [CI], 0.31-1.00). Significant heterogeneity between the trials was detected (I(2) = 67%). The significant reduction in the risk for diarrhea was lost in the random effects model (RR, 0.45; 95% CI, 0.11-1.75). Given the simple nature of the intervention, the scarcity of data is noteworthy. No consistent effect of yogurt consumption for preventing AAD was shown. However, the data are limited and the included trials had methodological limitations. Results from large, rigorously designed RCTs are needed to assess the effect of yogurt consumption on AAD prevention. Copyright © 2015 Elsevier Inc. All rights reserved.

Evaluating health effects of transport interventions methodologic case study.

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Ogilvie, David; Mitchell, Richard; Mutrie, Nanette; Petticrew, Mark; Platt, Stephen

2006-08-01

There is little evidence about the effects of environmental interventions on population levels of physical activity. Major transport projects may promote or discourage physical activity in the form of walking and cycling, but researching the health effects of such "natural experiments" in transport policy or infrastructure is challenging. Case study of attempts in 2004-2005 to evaluate the effects of two major transport projects in Scotland: an urban congestion charging scheme in Edinburgh, and a new urban motorway (freeway) in Glasgow. These interventions are typical of many major transport projects. They are unique to their context. They cannot easily be separated from the other components of the wider policies within which they occur. When, where, and how they are implemented are political decisions over which researchers have no control. Baseline data collection required for longitudinal studies may need to be planned before the intervention is certain to take place. There is no simple way of defining a population or area exposed to the intervention or of defining control groups. Changes in quantitative measures of health-related behavior may be difficult to detect. Major transport projects have clear potential to influence population health, but it is difficult to define the interventions, categorize exposure, or measure outcomes in ways that are likely to be seen as credible in the field of public health intervention research. A final study design is proposed in which multiple methods and spatial levels of analysis are combined in a longitudinal quasi-experimental study.

Evaluating the implementation process of a participatory organizational level occupational health intervention in schools.

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Schelvis, Roosmarijn M C; Wiezer, Noortje M; Blatter, Birgitte M; van Genabeek, Joost A G M; Oude Hengel, Karen M; Bohlmeijer, Ernst T; van der Beek, Allard J

2016-12-01

The importance of process evaluations in examining how and why interventions are (un) successful is increasingly recognized. Process evaluations mainly studied the implementation process and the quality of the implementation (fidelity). However, in adopting this approach for participatory organizational level occupational health interventions, important aspects such as context and participants perceptions are missing. Our objective was to systematically describe the implementation process of a participatory organizational level occupational health intervention aimed at reducing work stress and increasing vitality in two schools by applying a framework that covers aspects of the intervention and its implementation as well as the context and participants perceptions. A program theory was developed, describing the requirements for successful implementation. Each requirement was operationalized by making use of the framework, covering: initiation, communication, participation, fidelity, reach, communication, satisfaction, management support, targeting, delivery, exposure, culture, conditions, readiness for change and perceptions. The requirements were assessed by quantitative and qualitative data, collected at 12 and 24 months after baseline in both schools (questionnaire and interviews) or continuously (logbooks). The intervention consisted of a needs assessment phase and a phase of implementing intervention activities. The needs assessment phase was implemented successfully in school A, but not in school B where participation and readiness for change were insufficient. In the second phase, several intervention activities were implemented at school A, whereas this was only partly the case in school B (delivery). In both schools, however, participants felt not involved in the choice of intervention activities (targeting, participation, support), resulting in a negative perception of and only partial exposure to the intervention activities. Conditions, culture and

Evaluating the implementation process of a participatory organizational level occupational health intervention in schools

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Roosmarijn M. C. Schelvis

2016-12-01

Full Text Available Abstract Background The importance of process evaluations in examining how and why interventions are (un successful is increasingly recognized. Process evaluations mainly studied the implementation process and the quality of the implementation (fidelity. However, in adopting this approach for participatory organizational level occupational health interventions, important aspects such as context and participants perceptions are missing. Our objective was to systematically describe the implementation process of a participatory organizational level occupational health intervention aimed at reducing work stress and increasing vitality in two schools by applying a framework that covers aspects of the intervention and its implementation as well as the context and participants perceptions. Methods A program theory was developed, describing the requirements for successful implementation. Each requirement was operationalized by making use of the framework, covering: initiation, communication, participation, fidelity, reach, communication, satisfaction, management support, targeting, delivery, exposure, culture, conditions, readiness for change and perceptions. The requirements were assessed by quantitative and qualitative data, collected at 12 and 24 months after baseline in both schools (questionnaire and interviews or continuously (logbooks. Results The intervention consisted of a needs assessment phase and a phase of implementing intervention activities. The needs assessment phase was implemented successfully in school A, but not in school B where participation and readiness for change were insufficient. In the second phase, several intervention activities were implemented at school A, whereas this was only partly the case in school B (delivery. In both schools, however, participants felt not involved in the choice of intervention activities (targeting, participation, support, resulting in a negative perception of and only partial exposure to the

The effectiveness of community-based coordinating interventions in dementia care: a meta-analysis and subgroup analysis of intervention components.

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Backhouse, Amy; Ukoumunne, Obioha C; Richards, David A; McCabe, Rose; Watkins, Ross; Dickens, Chris

2017-11-13

Interventions aiming to coordinate services for the community-based dementia population vary in components, organisation and implementation. In this review we aimed to evaluate the effectiveness of community-based care coordinating interventions on health outcomes and investigate whether specific components of interventions influence their effects. We searched four databases from inception to April 2017: Medline, The Cochrane Library, EMBASE and PsycINFO. This was aided by a search of four grey literature databases, and backward and forward citation tracking of included papers. Title and abstract screening was followed by a full text screen by two independent reviewers, and quality was assessed using the CASP appraisal tool. We then conducted meta-analyses and subgroup analyses. A total of 14 randomised controlled trials (RCTs) involving 10,372 participants were included in the review. Altogether we carried out 12 meta-analyses and 19 subgroup analyses. Meta-analyses found coordinating interventions showed a statistically significant improvement in both patient behaviour measured using the Neuropsychiatric Inventory (NPI) (mean difference (MD) = -9.5; 95% confidence interval (CI): -18.1 to -1.0; p = 0.03; number of studies (n) = 4; I 2  = 88%) and caregiver burden (standardised mean difference (SMD) = -0.54; 95% CI: -1.01 to -0.07; p = 0.02; n = 5, I 2  = 92%) compared to the control group. Subgroup analyses found interventions using a case manager with a nursing background showed a greater positive effect on caregiver quality of life than those that used case managers from other professional backgrounds (SMD = 0.94 versus 0.03, respectively; p < 0.001). Interventions that did not provide supervision for the case managers showed greater effectiveness for reducing the percentage of patients that are institutionalised compared to those that provided supervision (odds ratio (OR) = 0.27 versus 0.96 respectively; p = 0.02). There was little

The effectiveness of community-based coordinating interventions in dementia care: a meta-analysis and subgroup analysis of intervention components

Directory of Open Access Journals (Sweden)

Amy Backhouse

2017-11-01

Full Text Available Abstract Background Interventions aiming to coordinate services for the community-based dementia population vary in components, organisation and implementation. In this review we aimed to evaluate the effectiveness of community-based care coordinating interventions on health outcomes and investigate whether specific components of interventions influence their effects. Methods We searched four databases from inception to April 2017: Medline, The Cochrane Library, EMBASE and PsycINFO. This was aided by a search of four grey literature databases, and backward and forward citation tracking of included papers. Title and abstract screening was followed by a full text screen by two independent reviewers, and quality was assessed using the CASP appraisal tool. We then conducted meta-analyses and subgroup analyses. Results A total of 14 randomised controlled trials (RCTs involving 10,372 participants were included in the review. Altogether we carried out 12 meta-analyses and 19 subgroup analyses. Meta-analyses found coordinating interventions showed a statistically significant improvement in both patient behaviour measured using the Neuropsychiatric Inventory (NPI (mean difference (MD = −9.5; 95% confidence interval (CI: −18.1 to −1.0; p = 0.03; number of studies (n = 4; I2 = 88% and caregiver burden (standardised mean difference (SMD = −0.54; 95% CI: -1.01 to −0.07; p = 0.02; n = 5, I2 = 92% compared to the control group. Subgroup analyses found interventions using a case manager with a nursing background showed a greater positive effect on caregiver quality of life than those that used case managers from other professional backgrounds (SMD = 0.94 versus 0.03, respectively; p < 0.001. Interventions that did not provide supervision for the case managers showed greater effectiveness for reducing the percentage of patients that are institutionalised compared to those that provided supervision (odds ratio (OR = 0.27 versus 0

A systematic review of interventions by healthcare professionals to improve management of non-communicable diseases and communicable diseases requiring long-term care in adults who are homeless.

Science.gov (United States)

Hanlon, Peter; Yeoman, Lynsey; Gibson, Lauren; Esiovwa, Regina; Williamson, Andrea E; Mair, Frances S; Lowrie, Richard

2018-04-07

Identify, describe and appraise trials of interventions delivered by healthcare professionals to manage non-communicable diseases (NCDs) and communicable diseases that require long-term care or treatment (LT-CDs), excluding mental health and substance use disorders, in homeless adults. Systematic review of randomised controlled trials (RCTs), non-RCTs and controlled before-after studies. Interventions characterised using Effective Practice and Organisation of Care (EPOC) taxonomy. Quality assessed using EPOC risk of bias criteria. Database searches (MEDLINE, Embase, PsycINFO, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Applied Social Sciences Index and Abstracts (ASSIA) and Cochrane Central Register of Controlled Trials), hand searching reference lists, citation searches, grey literature and contact with study authors. Community. Adults (≥18 years) fulfilling European Typology of Homelessness criteria. Delivered by healthcare professionals managing NCD and LT-CDs. Primary outcome: unscheduled healthcare utilisation. mortality, biological markers of disease control, adherence to treatment, engagement in care, patient satisfaction, knowledge, self-efficacy, quality of life and cost-effectiveness. 11 studies were included (8 RCTs, 2 quasi-experimental and 1 feasibility) involving 9-520 participants (67%-94% male, median age 37-49 years). Ten from USA and one from UK. Studies included various NCDs (n=3); or focused on latent tuberculosis (n=4); HIV (n=2); hepatitis C (n=1) or type 2 diabetes (n=1). All interventions were complex with multiple components. Four described theories underpinning intervention. Three assessed unscheduled healthcare utilisation: none showed consistent reduction in hospitalisation or emergency department attendance. Six assessed adherence to specific treatments, of which four showed improved adherence to latent tuberculosis therapy. Three concerned education case management, all of which improved disease

Interventions for improving modifiable risk factor control in the secondary prevention of stroke.

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Lager, Kate E; Mistri, Amit K; Khunti, Kamlesh; Haunton, Victoria J; Sett, Aung K; Wilson, Andrew D

2014-05-02

People with stroke or transient ischaemic attack (TIA) are at increased risk of future stroke and other cardiovascular events. Evidence-based strategies for secondary stroke prevention have been established. However, the implementation of prevention strategies could be improved. To assess the effects of stroke service interventions for implementing secondary stroke prevention strategies on modifiable risk factor control, including patient adherence to prescribed medications, and the occurrence of secondary cardiovascular events. We searched the Cochrane Stroke Group Trials Register (April 2013), the Cochrane Effective Practice and Organisation of Care Group Trials Register (April 2013), CENTRAL (The Cochrane Library 2013, issue 3), MEDLINE (1950 to April 2013), EMBASE (1981 to April 2013) and 10 additional databases. We located further studies by searching reference lists of articles and contacting authors of included studies. We included randomised controlled trials (RCTs) that evaluated the effects of organisational or educational and behavioural interventions (compared with usual care) on modifiable risk factor control for secondary stroke prevention. Two review authors selected studies for inclusion and independently extracted data. One review author assessed the risk of bias for the included studies. We sought missing data from trialists. This review included 26 studies involving 8021 participants. Overall the studies were of reasonable quality, but one study was considered at high risk of bias. Fifteen studies evaluated predominantly organisational interventions and 11 studies evaluated educational and behavioural interventions for patients. Results were pooled where appropriate, although some clinical and methodological heterogeneity was present. The estimated effects of organisational interventions were compatible with improvements and no differences in the modifiable risk factors mean systolic blood pressure (mean difference (MD) -2.57 mmHg; 95% confidence

Interventions for supporting informal caregivers of patients in the terminal phase of a disease.

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Candy, Bridget; Jones, Louise; Drake, Robyn; Leurent, Baptiste; King, Michael

2011-06-15

Patients in the terminal phase of a disease may have complex needs. It is often family and friends who play a central role in providing support, despite health professional input and regardless of whether the patient is at home or elsewhere. Such informal caring may involve considerable physical, psychological, and economic stresses. A range of supportive programmes for caregivers is being developed including psychological support and practical assistance. To assess the effects of supportive interventions that aim to improve the psychological and physical health of informal caregivers of patients in the terminal phase of their illness. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2 2010); MEDLINE (1950 to May 2010); EMBASE (1980 to May 2010); PsycINFO (1872 to May 2010); CINAHL (1937 to May 2010); National Health Service Research Register (2000 to November 2008) and Dissertation Abstracts (1716 to May 2010). We searched the reference lists of relevant studies; contacted experts; and handsearched journals. Randomised controlled trials (RCTs) of interventions to support adults who were caring for a friend or relative with a disease in the terminal phase. Interventions could include practical and emotional support and/or the facilitation of coping skills. Interventions could support caregivers indirectly via patient care. Two authors independently screened citations against the selection criteria. Data were extracted by one author and checked by another. This included extraction of any adverse effects. Risk of bias assessment was undertaken by two authors. We contacted trial authors to obtain missing information. Trial data were combined, where appropriate, on the review's primary outcomes. We included eleven RCTs involving 1836 caregiver participants. Nine interventions were delivered directly to the caregiver. Seven of these provided support in the caring role, another involved a family life review, and one

The design and application of comprehensive interventional surgery record:evaluation of its usefulness

International Nuclear Information System (INIS)

Li Xue; Chen Jinhua; Li Jun

2010-01-01

Objective: To design a comprehensive interventional surgery record form in order to standardize and simplify interventional work process and to increase the operative safety. Methods: A comprehensive interventional surgery record form was designed by the authors, which was suitable for making necessary record of different kinds of interventional procedures, for counting operation time, X-ray exposure time and for recording the dose, velocity and injection pressure of the contrast agent used in interventional procedure. The record form made a close combination of the nursing notes with the technological information and focused on compiling the clinical key points. The record form included independent parts for taking the preoperative, in-operative and postoperative facts and evaluations. The corresponding items after employing this record form were compared with that before using this form. The usefulness of the form was evaluated. Results: The use of comprehensive interventional surgery record form overcame the limitations of previously used interventional record chart. The previous record chart paid attention only to the vital signs and operative process, while the newly designed form emphasized the scientific management, which would make the therapeutic procedure to be more standard and the control of X-ray dose and contrast media dosage to be more strict, providing powerful data for scientific administration. After using the comprehensive interventional surgery record form both the nurses' and technicians' comprehensive abilities were improved markedly. Conclusion: The specific and comprehensive interventional record form designed by the authors fully meets the requirements of various interventional procedures, reflecting the particular needs for medical record. The use of this record form can standardize the administration of clinical interventional work. (authors)

Evaluation of a Workplace Disability Prevention Intervention in Canada: Examining Differing Perceptions of Stakeholders

OpenAIRE

Maiwald, Karin; de Rijk, Angelique; Guzman, Jaime; Schonstein, Eva; Yassi, Annalee

2010-01-01

Introduction Workplace disability prevention is important, but stakeholders can differ in their appreciation of such interventions. We present a responsive evaluation of a workplace disability prevention intervention in a Canadian healthcare organization. Three groups of stakeholders were included: designers of the intervention, deliverers, and workers. The aim was to examine the appreciation of this intervention by analyzing the discrepancies with respect to what these various stakeholders s...

Randomised controlled trials of psychological & pharmacological treatments for body dysmorphic disorder: A systematic review.

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Phillipou, Andrea; Rossell, Susan L; Wilding, Helen E; Castle, David J

2016-11-30

Treatment for body dysmorphic disorder (BDD) often involves a combination of psychological and pharmacological interventions. However, only a small number of randomised controlled trials (RCTs) have been undertaken examining the efficacy of different therapeutic interventions. The aim of this study was to systematically review the RCTs involving psychological and pharmacological interventions for the treatment of BDD. The literature was searched to June 2015, and studies were included if they were written in English, empirical research papers published in peer-review journals, specifically assessed BDD patients, and involved a RCT assessing BDD symptoms pre- and post-intervention. Nine studies were identified: six involving psychological and three involving pharmacological interventions. Cognitive behaviour therapy, metacognitive therapy and selective serotonin reuptake inhibitors were identified as treatments with potential benefit. The small number of RCTs and the heterogeneity of findings emphasises the need for more high quality RCTs assessing both psychological and pharmacological interventions for BDD. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Psychological, social and welfare interventions for psychological health and well-being of torture survivors.

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Patel, Nimisha; Kellezi, Blerina; Williams, Amanda C de C

2014-11-11

torture against any active or inactive comparison condition. We included all major sources of grey literature in our search and used standard methodological procedures as expected by The Cochrane Collaboration for collecting data, evaluating risk of bias and using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods to assess the quality of evidence. Nine RCTs were included in this review. All were of psychological interventions; none provided social or welfare interventions. The nine trials provided data for 507 adults; none involved children or adolescents. Eight of the nine studies described individual treatment, and one discussed group treatment. Six trials were conducted in Europe, and three in different African countries. Most people were refugees in their thirties and forties; most met the criteria for post-traumatic stress disorder (PTSD) at the outset. Four trials used narrative exposure therapy (NET), one cognitive-behavioural therapy (CBT) and the other four used mixed methods for trauma symptoms, one of which included reconciliation methods. Five interventions were compared with active controls, such as psychoeducation; four used treatment as usual or waiting list/no treatment; we analysed all control conditions together. Duration of therapy varied from one hour to longer than 20 hours with a median of around 12 to 15 hours. All trials reported effects on distress and on PTSD, and two reported on quality of life. Five studies followed up participants for at least six months.No immediate benefits of psychological therapy were noted in comparison with controls in terms of our primary outcome of distress (usually depression), nor for PTSD symptoms, PTSD caseness, or quality of life. At six-month follow-up, three NET and one CBT study (86 participants) showed moderate effect sizes for intervention over control in reduction of distress (standardised mean difference (SMD) -0.63, 95% confidence interval (CI) -1.07 to -0.19) and of PTSD

Evaluation of a Social Network Intervention for People with Mild to Borderline Intellectual Disabilities

Science.gov (United States)

van Asselt-Goverts, A. E.; Embregts, P. J. C. M.; Hendriks, A. H. C.

2018-01-01

Background: Little is known about the effectiveness of interventions aimed at enhancing the social networks of people with intellectual disabilities. This study explores the results of such an intervention. How did the clients with mild to borderline intellectual disabilities and their support workers evaluate the intervention? What did they learn…

Effectiveness of social marketing strategies to reduce youth obesity in European school-based interventions: a systematic review and meta-analysis.

Science.gov (United States)

Aceves-Martins, Magaly; Llauradó, Elisabet; Tarro, Lucia; Moreno-García, Carlos Francisco; Trujillo Escobar, Tamy Goretty; Solà, Rosa; Giralt, Montse

2016-05-01

The use of social marketing to modify lifestyle choices could be helpful in reducing youth obesity. Some or all of the 8 domains of the National Social Marketing Centre's social marketing benchmark criteria (SMBC) are often used but not always defined in intervention studies. The aim of this review is to assess the effectiveness of European school-based interventions to prevent obesity relative to the inclusion of SMBC domains in the intervention. The PubMed, Cochrane, and ERIC databases were used. Nonrandomized and randomized controlled trials conducted from 1990 to April 2014 in participants aged 5 to 17 years were included. After the study selection, the 8 domains of the SMBC were assessed in each included study. Thirty-eight publications were included in the systematic review. For the meta-analysis, randomized controlled trials (RCTs) reporting body mass index or prevalence of overweight and obesity were considered. Eighteen RCTs with a total of 8681 participants included at least 5 SMBC. The meta-analysis showed a small standardized mean difference in body mass index of -0.25 (95%CI, -0.45 to -0.04) and a prevalence of overweight and obesity odds ratio of 0.72 (95%CI, 0.5-0.97). Current evidence indicates that the inclusion of at least 5 SMBC domains in school-based interventions could benefit efforts to prevent obesity in young people. PROSPERO registration number: CRD42014007297. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute.

Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation.

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Östbring, Malin Johansson; Eriksson, Tommy; Petersson, Göran; Hellström, Lina

2018-01-30

Trials of complex interventions are often criticized for being difficult to interpret because the effects of apparently similar interventions vary across studies dependent on context, targeted groups, and the delivery of the intervention. The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a randomized controlled trial (RCT) of an intervention aimed at improving pharmacological secondary prevention. Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development of interventions, including descriptions of how the intervention is assumed to work, how this theory informed the process evaluation, and how the process evaluation relates to the outcome evaluation. This paper aims to describe how the intervention was designed and developed. The aim of the process evaluation is to better understand how and why the intervention in the MIMeRiC trial was effective or not effective. The research questions for evaluating the process are based on the conceptual model of change processes assumed in the intervention and will be analyzed by qualitative and quantitative methods. Quantitative data are used to evaluate the medication review in terms of drug-related problems, to describe how patients' beliefs about medicines are affected by the intervention, and to evaluate the quality of motivational interviewing. Qualitative data will be used to analyze whether patients experienced the intervention as intended, how cardiologists experienced the collaboration and intervention, and how the intervention affected patients' overall experience of care after coronary heart disease. The development and piloting of the intervention are described in relation to the theoretical framework. Data for the process evaluation will be collected until March 2018. Some process evaluation questions will be analyzed before, and others will be analyzed after the outcomes of the

Theory-Informed Interventions to Improve the Quality of Tuberculosis Evaluation at Ugandan Health Centers: A Quasi-Experimental Study.

Science.gov (United States)

Chaisson, Lelia H; Katamba, Achilles; Haguma, Priscilla; Ochom, Emmanuel; Ayakaka, Irene; Mugabe, Frank; Miller, Cecily; Vittinghoff, Eric; Davis, J Lucian; Handley, Margaret A; Cattamanchi, Adithya

2015-01-01

Tuberculosis (TB) remains under-diagnosed in many countries, in part due to poor evaluation practices at health facilities. Theory-informed strategies are needed to improve implementation of TB evaluation guidelines. We aimed to evaluate the impact of performance feedback and same-day smear microscopy on the quality of TB evaluation at 6 health centers in rural Uganda. We tested components of a multi-faceted intervention to improve adherence to the International Standards for Tuberculosis Care (ISTC): performance feedback and same-day smear microscopy. The strategies were selected based on a qualitative assessment guided by the Theory of Planned Behavior and the PRECEDE model. We collected patient data 6 months before and after the introduction of each intervention component, and compared ISTC adherence in the pre- and post-intervention periods for adults with cough ≥ 2 weeks' duration. The performance feedback evaluation included 1,446 adults; 838 (58%) were evaluated during the pre-intervention period and 608 (42%) during the post-intervention period. Performance feedback resulted in a 15% (95%CI +10% to +20%, pISTC-adherent care. The same-day microscopy evaluation included 1,950 adults; 907 (47%) were evaluated during the pre-intervention period and 1,043 (53%) during the post-intervention period. Same-day microscopy was associated with a 14% (95%CI +10% to +18%, pISTC-adherent care. Performance feedback and same-day microscopy should be considered along with ISTC training as part of a multi-faceted intervention to improve the quality of TB evaluation in other high TB burden countries.

It's Your Place: Development and Evaluation of an Evidence-Based Bystander Intervention Campaign.

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Sundstrom, Beth; Ferrara, Merissa; DeMaria, Andrea L; Gabel, Colby; Booth, Kathleen; Cabot, Jeri

2017-06-28

Preventing sexual assault on college campuses is a national priority. Bystander intervention offers a promising approach to change social norms and prevent sexual misconduct. This study presents the implementation and evaluation of a theory-based campaign to promote active bystander intervention. The theory of planned behavior (TPB) served as a conceptual framework throughout campaign development and evaluation. Formative research published elsewhere was used to develop campaign strategies, communication channels, and messages, including "It is your place to prevent sexual assault: You're not ruining a good time." The It's Your Place multi-media campaign fosters a culture of bystander intervention through peer-to-peer facilitation and training, as well as traditional and new media platforms. A cross-sectional post-test only web-based survey was designed to evaluate the campaign and test the TPB's ability to accurately predict intention to intervene. Survey data were collected from 1,505 currently enrolled students. The TPB model predicted intention to intervene. There was a significant effect of campaign exposure on attitude, subjective norms, and perceived behavioral intention. This theory-based communication campaign offers implications for promoting active bystander intervention and reducing sexual assault.

The three stages of building and testing mid-level theories in a realist RCT: a theoretical and methodological case-example.

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Jamal, Farah; Fletcher, Adam; Shackleton, Nichola; Elbourne, Diana; Viner, Russell; Bonell, Chris

2015-10-15

Randomised controlled trials (RCTs) of social interventions are often criticised as failing to open the 'black box' whereby they only address questions about 'what works' without explaining the underlying processes of implementation and mechanisms of action, and how these vary by contextual characteristics of person and place. Realist RCTs are proposed as an approach to evaluation science that addresses these gaps while preserving the strengths of RCTs in providing evidence with strong internal validity in estimating effects. In the context of growing interest in designing and conducting realist trials, there is an urgent need to offer a worked example to provide guidance on how such an approach might be practically taken forward. The aim of this paper is to outline a three-staged theoretical and methodological process of undertaking a realist RCT using the example of the evaluation of a whole-school restorative intervention aiming to reduce aggression and bullying in English secondary schools. First, informed by the findings of our initial pilot trial and sociological theory, we elaborate our theory of change and specific a priori hypotheses about how intervention mechanisms interact with context to produce outcomes. Second, we describe how we will use emerging findings from the integral process evaluation within the RCT to refine, and add to, these a priori hypotheses before the collection of quantitative, follow-up data. Third, we will test our hypotheses using a combination of process and outcome data via quantitative analyses of effect mediation (examining mechanisms) and moderation (examining contextual contingencies). The results are then used to refine and further develop the theory of change. The aim of the realist RCT approach is thus not merely to assess whether the intervention is effective or not, but to develop empirically informed mid-range theory through a three-stage process. There are important implications for those involved with reporting and

The Context, Process, and Outcome Evaluation Model for Organisational Health Interventions

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Fridrich, Annemarie; Jenny, Gregor J.; Bauer, Georg F.

2015-01-01

To facilitate evaluation of complex, organisational health interventions (OHIs), this paper aims at developing a context, process, and outcome (CPO) evaluation model. It builds on previous model developments in the field and advances them by clearly defining and relating generic evaluation categories for OHIs. Context is defined as the underlying frame that influences and is influenced by an OHI. It is further differentiated into the omnibus and discrete contexts. Process is differentiated into the implementation process, as the time-limited enactment of the original intervention plan, and the change process of individual and collective dynamics triggered by the implementation process. These processes lead to proximate, intermediate, and distal outcomes, as all results of the change process that are meaningful for various stakeholders. Research questions that might guide the evaluation of an OHI according to the CPO categories and a list of concrete themes/indicators and methods/sources applied within the evaluation of an OHI project at a hospital in Switzerland illustrate the model's applicability in structuring evaluations of complex OHIs. In conclusion, the model supplies a common language and a shared mental model for improving communication between researchers and company members and will improve the comparability and aggregation of evaluation study results. PMID:26557665

The Context, Process, and Outcome Evaluation Model for Organisational Health Interventions.

Science.gov (United States)

Fridrich, Annemarie; Jenny, Gregor J; Bauer, Georg F

2015-01-01

To facilitate evaluation of complex, organisational health interventions (OHIs), this paper aims at developing a context, process, and outcome (CPO) evaluation model. It builds on previous model developments in the field and advances them by clearly defining and relating generic evaluation categories for OHIs. Context is defined as the underlying frame that influences and is influenced by an OHI. It is further differentiated into the omnibus and discrete contexts. Process is differentiated into the implementation process, as the time-limited enactment of the original intervention plan, and the change process of individual and collective dynamics triggered by the implementation process. These processes lead to proximate, intermediate, and distal outcomes, as all results of the change process that are meaningful for various stakeholders. Research questions that might guide the evaluation of an OHI according to the CPO categories and a list of concrete themes/indicators and methods/sources applied within the evaluation of an OHI project at a hospital in Switzerland illustrate the model's applicability in structuring evaluations of complex OHIs. In conclusion, the model supplies a common language and a shared mental model for improving communication between researchers and company members and will improve the comparability and aggregation of evaluation study results.

Using theory of change to design and evaluate public health interventions: a systematic review.

Science.gov (United States)

Breuer, Erica; Lee, Lucy; De Silva, Mary; Lund, Crick

2016-05-06

Despite the increasing popularity of the theory of change (ToC) approach, little is known about the extent to which ToC has been used in the design and evaluation of public health interventions. This review aims to determine how ToCs have been developed and used in the development and evaluation of public health interventions globally. We searched for papers reporting the use of "theory of change" in the development or evaluation of public health interventions in databases of peer-reviewed journal articles such as Scopus, Pubmed, PsychInfo, grey literature databases, Google and websites of development funders. We included papers of any date, language or study design. Both abstracts and full text papers were double screened. Data were extracted and narratively and quantitatively summarised. A total of 62 papers were included in the review. Forty-nine (79 %) described the development of ToC, 18 (29 %) described the use of ToC in the development of the intervention and 49 (79 %) described the use of ToC in the evaluation of the intervention. Although a large number of papers were included in the review, their descriptions of the ToC development and use in intervention design and evaluation lacked detail. The use of the ToC approach is widespread in the public health literature. Clear reporting of the ToC process and outputs is important to strengthen the body of literature on practical application of ToC in order to develop our understanding of the benefits and advantages of using ToC. We also propose a checklist for reporting on the use of ToC to ensure transparent reporting and recommend that our checklist is used and refined by authors reporting the ToC approach.

Using mixed methods to develop and evaluate an online weight management intervention.

Science.gov (United States)

Bradbury, Katherine; Dennison, Laura; Little, Paul; Yardley, Lucy

2015-02-01

This article illustrates the use of mixed methods in the development and evaluation of the Positive Online Weight Reduction (POWeR) programme, an e-health intervention designed to support sustainable weight loss. The studies outlined also explore how human support might enhance intervention usage and weight loss. Mixed methods were used to develop and evaluate POWeR. In the development phase, we drew on both quantitative and qualitative findings to plan and gain feedback on the intervention. Next, a feasibility trial, with nested qualitative study, explored what level of human support might lead to the most sustainable weight loss. Finally, a large community-based trial of POWeR, with nested qualitative study, explored whether the addition of brief telephone coaching enhances usage. Findings suggest that POWeR is acceptable and potentially effective. Providing human support enhanced usage in our trials, but was not unproblematic. Interestingly, there were some indications that more basic (brief) human support may produce more sustainable weight loss outcomes than more regular support. Qualitative interviews suggested that more regular support might foster reliance, meaning patients cannot sustain their weight losses when support ends. Qualitative findings in the community trial also suggested explanations for why many people may not take up the opportunity for human support. Integrating findings from both our qualitative and quantitative studies provided far richer insights than would have been gained using only a single method of inquiry. Further research should investigate the optimum delivery of human support needed to maximize sustainable weight loss in online interventions. Statement of contribution What is already known on this subject? There is evidence that human support may increase the effectiveness of e-health interventions. It is unclear what level of human support might be optimal or how human support improves effectiveness. Triangulation of

Dancing for Healthy Aging: Functional and Metabolic Perspectives.

Science.gov (United States)

Rodrigues-Krause, Josianne; Krause, Mauricio; Reischak-Oliveira, Alvaro

2018-02-10

Context • Dancing has been used as a form of exercise to improve functional and metabolic outcomes during aging. The field lacks randomized, clinical trials (RCTs) evaluating metabolic outcomes related to dance interventions, but dancing may be a form of exercise that could induce positive effects on the metabolic health of older adults. However, primary studies seem very heterogonous regarding the trial designs, characteristics of the interventions, the methods for outcomes assessments, statistical powers, and methodological quality. Objective • The current research team intended to review the literature on the use of dance as a form of intervention to promote functional and metabolic health in older adults. Specifically, the research team aimed to identify and describe the characteristics of a large range of studies using dance as an intervention, summarizing them and putting them into perspective for further analysis. Design • The research team searched the following data sources-MEDLINE, Cochrane Wiley, Clinical Trials.gov, the Physiotherapy Evidence Database (PEDRO), and the Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS)-for RCTs, quasi-experimental studies, and observational trials that compared the benefits of any style of dancing, combined with other exercises or alone, to nonexercising controls and/or controls practicing other types of exercise. Setting • The study took place at the Federal University of Rio Grande do Sul (Porto Alegre, Brazil). Participants were aging individuals, >55 y, both with or without health conditions. Interventions • Interventions should be supervised, taking form as group classes, in a dance setting environment. Dance styles were divided into 5 categories for the review: (1) cultural dances developed by groups of people to reflect the roots of a certain region, such as Greek dance; (2) ballroom dance (ie, dances with partners performed socially or competitively in a ballroom, such as foxtrot

An evaluation of a stress management intervention for parents of ...

African Journals Online (AJOL)

An evaluation of a stress management intervention for parents of children with Attention-Deficit/Hyperactivity Disorder. ... Current Issue · Archives · Journal Home > Vol 3, No 1 (2011) >. Log in or Register to get access to full text downloads.

Interventions for promoting participation in shared decision-making for children with cancer.

Science.gov (United States)

Coyne, Imelda; O'Mathúna, Dónal P; Gibson, Faith; Shields, Linda; Leclercq, Edith; Sheaf, Greg

2016-11-29

Conference of the International Society for Paediatric Oncology (SIOP) and Annual Scientific Meeting of the Society for Medical Decision Making (SMDM). We scanned the ISRCTN (International Standard Randomised Controlled Trial Number) register and the National Institutes of Health (NIH) Register for ongoing trials on 29 February 2016. For this update, we included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of SDM interventions for children with cancer aged four to 18 years. The types of decisions included were: treatment, health care and research participation decisions. The primary outcome was SDM as measured with any validated scale. Two review authors undertook the searches, and three review authors independently assessed the studies obtained. We contacted study authors for additional information. No studies met the inclusion criteria, and hence no analysis could be undertaken. No conclusions can be made on the effects of interventions to promote SDM for children with cancer aged four to 18 years. This review has highlighted the dearth of high-quality quantitative research on interventions to promote participation in SDM for children with cancer. There are many potential reasons for the lack of SDM intervention studies with children. Attitudes towards children's participation are slowly changing in society and such changes may take time to be translated or adopted in healthcare settings. The priority may be on developing interventions that promote children's participation in communication interactions since information-sharing is a prerequisite for SDM. Restricting this review to RCTs was a limitation and extending the review to non-randomised studies (NRS) may have produced more evidence. For this update, we included only RCTs and CCTs. Clearly more research is needed.

Evaluating social outcomes of HIV/AIDS interventions: a critical assessment of contemporary indicator frameworks.

Science.gov (United States)

Mannell, Jenevieve; Cornish, Flora; Russell, Jill

2014-01-01

Contemporary HIV-related theory and policy emphasize the importance of addressing the social drivers of HIV risk and vulnerability for a long-term response. Consequently, increasing attention is being given to social and structural interventions, and to social outcomes of HIV interventions. Appropriate indicators for social outcomes are needed in order to institutionalize the commitment to addressing social outcomes. This paper critically assesses the current state of social indicators within international HIV/AIDS monitoring and evaluation frameworks. We analyzed the indicator frameworks of six international organizations involved in efforts to improve and synchronize the monitoring and evaluation of the HIV/AIDS response. Our analysis classifies the 328 unique indicators according to what they measure and assesses the degree to which they offer comprehensive measurement across three dimensions: domains of the social context, levels of change and organizational capacity. The majority of indicators focus on individual-level (clinical and behavioural) interventions and outcomes, neglecting structural interventions, community interventions and social outcomes (e.g. stigma reduction; community capacity building; policy-maker sensitization). The main tool used to address social aspects of HIV/AIDS is the disaggregation of data by social group. This raises three main limitations. Indicator frameworks do not provide comprehensive coverage of the diverse social drivers of the epidemic, particularly neglecting criminalization, stigma, discrimination and gender norms. There is a dearth of indicators for evaluating the social impacts of HIV interventions. Indicators of organizational capacity focus on capacity to effectively deliver and manage clinical services, neglecting capacity to respond appropriately and sustainably to complex social contexts. Current indicator frameworks cannot adequately assess the social outcomes of HIV interventions. This limits knowledge about

Economic evaluation of a participatory ergonomics intervention in a textile plant.

Science.gov (United States)

Tompa, Emile; Dolinschi, Roman; Natale, Julianne

2013-05-01

In this study we report on the economic evaluation of a participatory ergonomics process undertaken at a clothing manufacturer in Southwestern Ontario, Canada that employs approximately 300 workers. We undertake a cost-benefit analysis from the company perspective. Intervention costs amounted to $65,787 and intervention benefits $360,614 (2011 Canadian dollars). The net present value was $294,827, suggesting that the intervention was worth undertaking based on the costs and consequences over the measurement period spanning more than four years. Based on these costs and benefits, the benefit-to-cost ratio is 5.5. Overall, the findings from this study suggest that participatory ergonomics interventions can be cost beneficial from the company perspective. Even though the changes were typically low-cost and low-tech interventions implemented by the plant mechanics and maintenance personnel, benefits were realized on both the health and financial fronts. Copyright © 2012 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Clinical evaluation of interventional treatment for Budd-Chiari syndrome

International Nuclear Information System (INIS)

Zhong Hongshan; Xu Ke; Xiao Liang

2009-01-01

Objective: To evaluate the interventional treatment of Budd-Chiari syndrome (BCS) with regard to different types of the disease. Methods: One hundred and fifty-nine consecutive cases with BCS underwent interventional treatments with regard to different types of the diseases, including percutaneous angioplasty (PTA), transcatheter thrombolysis, endovascular stent implantation and modified transjugular intrahepatic portosystemic shunt (MTIPS). Among them, 147 cases that underwent complete follow-up were enrolled in this study. Simple obstruction of HV, membranous obstruction of IVC, membranous obstruction of IVC combined with thrombosis in the distal lumen and segmental obstruction of IVC constituted 13.6% (20), 66.0% (97), 6.1% (9)and 14.3% (21/147), respectively. The technical success rate of each type was determined. They were followed up for (67.3±9.0) months (16 h-104 months). Overall primary patency rate was evaluated. The late effect on liver function was analyzed according to the Child-Pugh score. Results: The primary patency rate of PTA was 65.6% (86/131) and the secondary, patency rate was 96.9% (124/128). The primary patency rate of stent implantation was 78.9% (15/19) and the secondary patency rate was 92.3% (24/26). One patient of type IIIa that received recanalization, catheter-directed thrombolysis and PTA in IVC died of hemoptysis 72 h after the procedure. One patients of type I b who received MTIPS died of DIC 16 hrs after the procedure. And one patient of type Ib who received MTIPS died of liver failure 13 months after the procedure. Twelve patients died in 7-79 months after the interventional procedure due to unrelated causes. At the end of follow-up, the liver function of the patients was improved. Conclusions: Optimal application of various vascular interventional techniques has a satisfactory primary and secondary patency rate and improves the long-term liver function. (authors)

Recent controversies on comparative effectiveness research investigations: Challenges, opportunities, and pitfalls.

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Kirpalani, Haresh; Truog, William E; D'Angio, Carl T; Cotten, Michael

2016-10-01

The purpose of comparative effectiveness research (CER) is to improve health outcomes by developing and disseminating evidence-based information about which currently available interventions and practices are most effective for patients. Randomized Controlled Trials (RCT) are the hallmark of scientific proof, and have been used to compare interventions used in variable ways by different clinicians (comparative effectiveness RCTs, CER-RCTs). But such CER-RCTs have at times generated controversy. Usually the background for the CER-RCT is a range of "standard therapy" or "standard of care." This may have been adopted on observational data alone, or pilot data. At times, such prior data may derive from populations that differ from the population in which the widely variable standard approach is being applied. We believe that controversies related to these CER-RCTs result from confusing "accepted" therapies and "rigorously evaluated therapies." We first define evidence-based medicine and consider how well neonatology conforms to that definition. We then contrast the approach of testing new therapies and those already existing and widely adopted, as in CER-RCTs. We next examine a central challenge in incorporating the control arm within CER-RCTs and aspects of the "titrated" trial. We finally briefly consider some ethical issues that have arisen, and discuss the wide range of neonatology practices that could be tested by CER-RCTs or alternative CER-based strategies that might inform practice. Throughout, we emphasize the lack of awareness of the lay community, and indeed many researchers or commentators, in appreciating the wide variation of standard of care. There is a corresponding need to identify the best uses of available resources that will lead to the best outcomes for our patients. We conclude that CER-RCTs are an essential methodology in modern neonatology to address many unanswered questions and test unproven therapies in newborn care. Copyright © 2016

Theory-Informed Interventions to Improve the Quality of Tuberculosis Evaluation at Ugandan Health Centers: A Quasi-Experimental Study.

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Lelia H Chaisson

Full Text Available Tuberculosis (TB remains under-diagnosed in many countries, in part due to poor evaluation practices at health facilities. Theory-informed strategies are needed to improve implementation of TB evaluation guidelines. We aimed to evaluate the impact of performance feedback and same-day smear microscopy on the quality of TB evaluation at 6 health centers in rural Uganda.We tested components of a multi-faceted intervention to improve adherence to the International Standards for Tuberculosis Care (ISTC: performance feedback and same-day smear microscopy. The strategies were selected based on a qualitative assessment guided by the Theory of Planned Behavior and the PRECEDE model. We collected patient data 6 months before and after the introduction of each intervention component, and compared ISTC adherence in the pre- and post-intervention periods for adults with cough ≥ 2 weeks' duration.The performance feedback evaluation included 1,446 adults; 838 (58% were evaluated during the pre-intervention period and 608 (42% during the post-intervention period. Performance feedback resulted in a 15% (95%CI +10% to +20%, p<0.001 increase in the proportion of patients receiving ISTC-adherent care. The same-day microscopy evaluation included 1,950 adults; 907 (47% were evaluated during the pre-intervention period and 1,043 (53% during the post-intervention period. Same-day microscopy was associated with a 14% (95%CI +10% to +18%, p<0.001 increase in the proportion of patients receiving ISTC-adherent care.Performance feedback and same-day microscopy should be considered along with ISTC training as part of a multi-faceted intervention to improve the quality of TB evaluation in other high TB burden countries.

Comparison Groups in Yoga Research: A Systematic Review and Critical Evaluation of the Literature

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Groessl, Erik; Maiya, Meghan; Sarkin, Andrew; Eisen, Susan V.; Riley, Kristen; Elwy, A. Rani

2014-01-01

Objectives Comparison groups are essential for accurate testing and interpretation of yoga intervention trials. However, selecting proper comparison groups is difficult because yoga comprises a very heterogeneous set of practices and its mechanisms of effect have not been conclusively established. Methods We conducted a systematic review of the control and comparison groups used in published randomized controlled trials (RCTs) of yoga. Results We located 128 RCTs that met our inclusion criteria; of these, 65 included only a passive control and 63 included at least one active comparison group. Primary comparison groups were physical exercise (43%), relaxation/meditation (20%), and education (16%). Studies rarely provided a strong rationale for choice of comparison. Considering year of publication, the use of active controls in yoga research appears to be slowly increasing over time. Conclusions Given that yoga has been established as a potentially powerful intervention, future research should use active control groups. Further, care is needed to select comparison conditions that help to isolate the specific mechanisms of yoga’s effects. PMID:25440384

Recent randomized controlled trials in otolaryngology.

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Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

2015-03-01

To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

Intervention of drudgery reducing technologies in agriculture and impact evaluation.

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Mehta, Manju; Gandhi, Sudesh; Dilbaghi, Mamta

2012-01-01

Agriculture is main source of livelihood for majority of the population in India. Agriculture has been established as one of the drudgery prone occupation of unorganized sector due to lack of access to improved agricultural technologies. The present study was planned to assess intervention of drudgery reducing technologies in agriculture and its impact evaluation. The drudgery areas/activities in agriculture were identified. Participatory field level skill training for proper use of the ergonomically improved farm technologies were given to men and women in separate groups. An intervention package consisting of improved sickle, wheel hand hoe, capron, cot bag and protective gloves was introduced in village Shahpur. Data were collected to quantify the impact of intervention on the level of drudgery of worker before and after the technology intervention from sample of 30 respondents (15 male and 15 female) selected randomly from village Shahpur. Gain in knowledge and change in awareness level were calculated after the training.Evaluation of field validation of technology on drudgery of men & women was done after its use in the field conditions. A significant gain in awareness was observed among both men(2.6) & women (3.0) whereas the gain in knowledge was more among men (6.6) than women (4.5). In evaluation of field validation of technology on drudgery it was found that all the five technologies reduced the drudgery of men as well as women. However wheel hand hoe was used successfully by men in comparison to women who preferred to use their conventional technology i.e improved long-handled hoe. Evaluation of validation trials of the technologies reported that improved sickle was used successfully by both men & women farmers. More than half of the men farmers (53.3%) & only 13.3 percent women farmers preferred the wheel hand hoe over the traditional one as they found it four times more efficient in terms of time, energy & money saving. Cot bag was preferred by the

Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis

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Jairath, Vipul; Zou, Guangyong; Parker, Claire E.; Macdonald, John K.; Mosli, Mahmoud H.; Khanna, Reena; Shackelton, Lisa M.; Vandervoort, Margaret K.; AlAmeel, Turki; Al Beshir, Mohammad; AlMadi, Majid; Al-Taweel, Talal; Atkinson, Nathan S. S.; Biswas, Sujata; Chapman, Thomas P.; Dulai, Parambir S.; Glaire, Mark A.; Hoekman, Daniel; Koutsoumpas, Andreas; Minas, Elizabeth; Samaan, Mark A.; Travis, Simon; D'Haens, Geert; Levesque, Barrett G.; Sandborn, William J.; Feagan, Brian G.

2016-01-01

Minimisation of the placebo responses in randomised controlled trials [RCTs] is essential for efficient evaluation of new interventions. Placebo rates have been high in ulcerative colitis [UC] clinical trials, and factors influencing this are poorly understood. We quantify placebo response and

Evaluation of an ergonomics intervention among Nicaraguan coffee harvesting workers.

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Bao, Stephen; Silverstein, Barbara; Stewart, Kate

2013-01-01

This study evaluated an ergonomics intervention among Nicaraguan coffee harvesting workers, using electromyography and questionnaire survey techniques. Nicaraguan researchers were involved in the study so that they could gain hands-on experience with ergonomics research and applications, and eventually be the specialists conducting ergonomics interventions in Nicaraguan workplaces. Coffee harvesting activities were studied individually and physical hazards were identified accordingly. The results showed decreased muscle loading on the erector spinae muscle and improved comfort reporting in the back region compared to the commonly used baskets. This fulfils the design objective of a newly developed bag that was used in the intervention to reduce physical workload on the coffee harvesting workers. Workers' opinion survey results showed some issues related to the size of the new bag and the lumbar-shoulder belt mechanism. This information can be used in the modification of the bag in the next design. Key players in the process have been identified. Stimulating ergonomics activities in developing countries is suggested by many experts. This study provided an example from coffee workers in Nicaragua. Commonly used job evaluation procedures and physical load quantification methods were used. Ergonomics researchers and practitioners in developing countries may do similar projects on their own in the future.

Health promotion and psychological interventions for adolescent and young adult cancer survivors: A systematic literature review.

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Bradford, Natalie Katrina; Chan, Raymond Javan

2017-04-01

The effects of cancer and treatment have severe and long lasting negative impacts on quality of life. Adolescents and Young Adults (AYA) have high survival rates but may not reach their full life potential because of these consequences. This review aims to identify, appraise and synthesise the effects of health promotion and psychological interventions for AYA after cancer treatment. The review was undertaken using the preferred reporting items for systematic reviews and meta-analyses guidelines. Included studies were identified though a range of electronic databases through to May 2016. Studies were critically appraised using the Cochrane Risk of Bias tool. Seventeen studies, comprising a total of 2314 participants aged 13-39years were included in this review. Participants in 15 studies were survivors of childhood cancer, with only two studies specifically recruiting survivors of cancer diagnosed during young adulthood. Ten studies were randomised controlled trials (RCTs); the remaining seven were before and after studies. The quality of studies was variable across all appraised domains; risk of bias was evident in regards to recruitment, measures of exposure and outcomes, confounding factors, attrition and lost-to follow-up. Studies evaluated a range of health promotion and psychological interventions to improve health related and process outcomes. Eleven studies reported modest positive outcomes, with psychological and physical activity interventions achieving greater success compared to general health promotion interventions. This review highlights the lack of high-quality studies for optimising the health and well-being of AYA cancer survivors. No conclusive evidence favouring specific interventions were identified, although recommendations for future studies are made. Interventions delivered face-to-face and those that facilitate peer-to-peer support hold promise. Harnessing social media and technology to deliver interventions is likely to increase and these

Evaluating different dimensions of programme effectiveness for private medicine retailer malaria control interventions in Kenya.

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Timothy O Abuya

2010-01-01

Full Text Available Private medicine retailers (PMRs are key partners in the home management of fevers in many settings. Current evidence on effectiveness for PMR interventions at scale is limited. This study presents evaluation findings of two different programs implemented at moderate scale targeting PMRs for malaria control in the Kisii and Kwale districts of Kenya. Key components of this evaluation were measurement of program performance, including coverage, PMR knowledge, practices, and utilization based on spatial analysis.The study utilized mixed quantitative methods including retail audits and surrogate client surveys based on post-intervention cross-sectional surveys in intervention and control areas and mapping of intervention outlets. There was a large and significant impact on PMR knowledge and practices of the program in Kisii, with 60.5% of trained PMRs selling amodiaquine medicines in adequate doses compared to 2.8% of untrained ones (OR; 53.5: 95% CI 6.7, 428.3, a program coverage of 69.7% targeted outlets, and a potential utilization of about 30,000 children under five. The evaluation in Kwale also indicates a significant impact with 18.8% and 2.3% intervention and control PMRs selling amodiaquine with correct advice, respectively (OR; 9.4: 95% CI 1.1, 83.7, a program coverage of 25.3% targeted outlets, and a potential utilization of about 48,000 children under five. A provisional benchmark of 7.5 km was a reasonable threshold distance for households to access PMR services.This evaluation show that PMR interventions operationalized in the district level settings are likely to impact PMR knowledge and practices and lead to increased coverage of appropriate treatment to target populations. There is value of evaluating different dimensions of public health programs, including quality, spatial access, and implementation practice. This approach strengthens the potential contribution of pragmatic study designs to evaluating public health programs in the

A systematic review of exercise and psychosocial rehabilitation interventions to improve health-related outcomes in patients with bladder cancer undergoing radical cystectomy.

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Rammant, Elke; Decaestecker, Karel; Bultijnck, Renée; Sundahl, Nora; Ost, Piet; Pauwels, Nele S; Deforche, Benedicte; Pieters, Ronny; Fonteyne, Valérie

2018-05-01

Summarizing the evidence on the effects of pre- and postoperative exercise and psychosocial rehabilitation interventions on patient-reported outcomes (PROs) and physical fitness in bladder cancer patients undergoing radical cystectomy. The Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Web of Science and the Physiotherapy Evidence Database were searched independently by two authors from inception until 10 November 2017. Cited references of the studies and citing references retrieved via Web of Science were also checked. Randomized controlled trials (RCTs) and non-randomized studies assessing effects of exercise and psychosocial interventions in bladder cancer patients undergoing radical cystectomy were eligible. Primary outcome measures were PROs and physical fitness. Risk of bias was assessed using the Cochrane Collaboration tool and the Newcastle-Ottawa Scale. Five RCTs (three exercise and two psychosocial studies) and one non-randomized psychosocial study comprising 317 bladder cancer patients were included. Timing of the intervention was preoperative ( n = 2), postoperative ( n = 2) or both pre- and postoperative ( n = 2). Positive effects of exercise were found for physical fitness ( n = 3), some health-related quality-of-life (HRQoL) domains ( n = 2), personal activities in daily living ( n = 1) and muscle strength ( n = 1). Psychosocial interventions showed positive effects on anxiety ( n = 1), fatigue ( n = 1), depression ( n = 1), HRQoL ( n = 1) and posttraumatic growth ( n = 1). Quality assessment showed most shortcomings with sample sizes and strong heterogeneity was observed between studies. The evidence relating to the effects of exercise in bladder cancer is very limited and is even less for psychosocial interventions.

Effect evaluation of a multifactor community intervention to reduce falls among older persons

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Wijlhuizen, G.J.; Bois, P. du; Dommelen, P. van; Hopman-Rock, M.

2007-01-01

The objective of the study was to evaluate the effectiveness of a multifactor and multimethod community intervention programme to reduce falls among older persons by at least 20%. In a pre-test-post test design, self-reported falls were registered for 10 months in the intervention community and two

Psychological Care, Patient Education, Orthotics, Ergonomics and Prevention Strategies for Neck Pain: An Systematic Overview Update as Part of the ICON§ Project

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Gross, Anita R.; Kaplan, Faith; Huang, Stacey; Khan, Mahweesh; Santaguida, P. Lina; Carlesso, Lisa C.; MacDermid, Joy C.; Walton, David M.; Kenardy, Justin; Söderlund, Anne; Verhagen, Arianne; Hartvigsen, Jan

2013-01-01

Objectives: To conduct an overview on psychological interventions, orthoses, patient education, ergonomics, and 1⁰/2⁰ neck pain prevention for adults with acute-chronic neck pain. Search Strategy: Computerized databases and grey literature were searched (2006-2012). Selection Criteria: Systematic reviews of randomized controlled trials (RCTs) on pain, function/disability, global perceived effect, quality-of-life and patient satisfaction were retrieved. Data Collection & Analysis: Two independent authors selected articles, assessed risk of bias using AMSTAR tool and extracted data. The GRADE tool was used to evaluate the body of evidence and an external panel to provide critical review. Main Results: We retrieved 30 reviews (5-9 AMSTAR score) reporting on 75 RCTs with the following moderate GRADE evidence. For acute whiplash associated disorder (WAD), an education video in emergency rooms (1RCT, 405participants] favoured pain reduction at long-term follow-up thus helping 1 in 23 people [Standard Mean Difference: -0.44(95%CI: -0.66 to -0.23)). Use of a soft collar (2RCTs, 1278participants) was not beneficial in the long-term. For chronic neck pain, a mind-body intervention (2RCTs, 1 meta-analysis, 191participants) improved short-term pain/function in 1 of 4 or 6 participants. In workers, 2-minutes of daily scapula-thoracic endurance training (1RCT, 127participants) over 10 weeks was beneficial in 1 of 4 participants. A number of psychosocial interventions, workplace interventions, collar use and self-management educational strategies were not beneficial. Reviewers' Conclusions: Moderate evidence exists for quantifying beneficial and non-beneficial effects of a limited number of interventions for acute WAD and chronic neck pain. Larger trials with more rigorous controls need to target promising interventions PMID:24133554

Building an Evidence Base to Inform Interventions for Pregnant and Parenting Adolescents: A Call for Rigorous Evaluation

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Burrus, Barri B.; Scott, Alicia Richmond

2012-01-01

Adolescent parents and their children are at increased risk for adverse short- and long-term health and social outcomes. Effective interventions are needed to support these young families. We studied the evidence base and found a dearth of rigorously evaluated programs. Strategies from successful interventions are needed to inform both intervention design and policies affecting these adolescents. The lack of rigorous evaluations may be attributable to inadequate emphasis on and sufficient funding for evaluation, as well as to challenges encountered by program evaluators working with this population. More rigorous program evaluations are urgently needed to provide scientifically sound guidance for programming and policy decisions. Evaluation lessons learned have implications for other vulnerable populations. PMID:22897541

Evaluating Cost-Effectiveness of Interventions that Affect Fertility and Childbearing: How Health Effects are Measured Matters

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Goldhaber-Fiebert, Jeremy D.; Brandeau, Margaret L.

2015-01-01

Background Current guidelines for economic evaluations of health interventions define relevant outcomes as those accruing to individuals receiving interventions. Little consensus exists on counting health impacts on current and future fertility and childbearing. Objective To characterize current practices for counting such health outcomes. Design We developed a framework characterizing health interventions with direct and/or indirect effects on fertility and childbearing and how such outcomes are reported. We identified interventions spanning the framework and performed a targeted literature review for economic evaluations of these interventions. For each article, we characterized how the potential health outcomes from each intervention were considered, focusing on QALYs associated with fertility and childbearing. Results We reviewed 108 studies, identifying seven themes: 1) Studies were heterogeneous in reporting outcomes. 2) Studies often selected outcomes for inclusion that tend to bias toward finding the intervention to be cost-effective. 3) Studies often avoided the challenges of assigning QALYs for pregnancy and fertility by instead considering cost per intermediate outcome. 4) Even for the same intervention, studies took heterogeneous approaches to outcome evaluation. 5) Studies employed multiple, competing rationales for whether and how to include fertility-related QALYs and whose QALYs to include. 6) Studies examining interventions with indirect effects on fertility typically ignored such QALYs. 7) Even recent studies had these shortcomings. Limitations The review was targeted rather than systematic. Conclusions Economic evaluations inconsistently consider QALYs from current and future fertility and childbearing in ways that frequently appear biased towards the interventions considered. As the Panel on Cost-Effectiveness in Health and Medicine updates its guidelines, making the practice of cost-effectiveness analysis more consistent is a priority. Our

What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

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Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

2015-11-01

Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

Educational interventions to train healthcare professionals in end-of-life communication: a systematic review and meta-analysis.

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Chung, Han-Oh; Oczkowski, Simon J W; Hanvey, Louise; Mbuagbaw, Lawrence; You, John J

2016-04-29

Practicing healthcare professionals and graduates exiting training programs are often ill-equipped to facilitate important discussions about end-of-life care with patients and their families. We conducted a systematic review to evaluate the effectiveness of educational interventions aimed at providing healthcare professionals with training in end-of-life communication skills, compared to usual curriculum. We searched MEDLINE, Embase, CINAHL, ERIC and the Cochrane Central Register of Controlled Trials from the date of inception to July 2014 for randomized control trials (RCT) and prospective observational studies of educational training interventions to train healthcare professionals in end-of-life communication skills. To be eligible, interventions had to provide communication skills training related to end-of-life decision making; other interventions (e.g. breaking bad news, providing palliation) were excluded. Our primary outcomes were self-efficacy, knowledge and end-of-life communication scores with standardized patient encounters. Sufficiently similar studies were pooled in a meta-analysis. The quality of evidence was assessed using GRADE. Of 5727 candidate articles, 20 studies (6 RCTs, 14 Observational) were included in this review. Compared to usual teaching, educational interventions to train healthcare professionals in end-of-life communication skills were associated with greater self-efficacy (8 studies, standardized mean difference [SMD] 0.57;95% confidence interval [CI] 0.40-0.75; P communication scores (8 studies, SMD 0.69; 95% CI 0.41-0.96; p communication training may improve healthcare professionals' self-efficacy, knowledge, and EoL communication scores compared to usual teaching. Further studies comparing two active educational interventions are recommended with a continued focus on contextually relevant high-level outcomes. PROSPERO CRD42014012913.

Pharmacological interventions for preventing post-traumatic stress disorder (PTSD).

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Amos, Taryn; Stein, Dan J; Ipser, Jonathan C

2014-07-08

Post-traumatic stress disorder (PTSD) is a debilitating disorder which, after a sufficient delay, may be diagnosed amongst individuals who respond with intense fear, helplessness or horror to traumatic events. There is some evidence that the use of pharmacological interventions immediately after exposure to trauma may reduce the risk of developing of PTSD. To assess the effects of pharmacological interventions for the prevention of PTSD in adults following exposure to a traumatic event. We searched the Cochrane Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR-Studies and CCDANCTR-References) (to 14 February 2014). This register contains relevant reports of randomised controlled trials from the following bibliographic databases: CENTRAL (all years); EMBASE (1974 to date); MEDLINE (1950 to date) and PsycINFO (1967 to date). We identified unpublished trials by searching the National Institute of Health (NIH) Reporter, the metaRegister of Controlled Trials database (mRCT) and the WHO International Clinical Trials Registry Platform (to December 2013). We scanned the reference lists of articles for additional studies. We placed no constraints on language and setting. We restricted studies to randomised controlled trials (RCTs) of pharmacological interventions compared with placebo for the prevention of PTSD in adults. Two authors (TA and JI) independently assessed trials for eligibility and inclusion based on the review selection criteria. We independently extracted sample, methodological, outcome and 'Risk of bias' data, as well as the number of side effects, from each trial and entered these into a customised data extraction form. We contacted investigators for missing information. We calculated summary statistics for continuous and dichotomous variables (if provided). We did not undertake subgroup analyses due to the small number of included studies. We included nine short-term RCTs (duration 12 weeks or less) in the analysis (345 participants

Physical therapy interventions for gross motor skills in people with an intellectual disability aged 6 years and over: a systematic review.

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Hocking, Judith; McNeil, Julian; Campbell, Jared

2016-12-01

The systematic review was undertaken to investigate the effectiveness of physical therapy interventions for improving gross motor skills (GMSs) in people with an intellectual disability aged 6 years and older. There is a lack of physical therapy research for GMSs in this population, and no prior systematic review. People with an intellectual disability may require specific teaching approaches within therapy interventions to accommodate their cognitive and learning needs. People with an intellectual disability who suffer from GMS deficits can benefit from physical therapy to help improve their GMSs. Data sources were PubMed, CINAHL, Embase, and ProQuest. Reference lists of relevant identified articles were also hand searched. Papers published in English from 1 January 2008 to 22 October 2014 were considered for inclusion. This start date was chosen to reflect the tenets of the United Nations Convention on the Rights of Persons with Disabilities which was ratified in 2008.Eligible study designs for inclusion were randomized controlled trial (RCT), pseudo-RCT, repeated measures, and case report. Overall, 887 potential articles were identified, of which 42 were retrieved for full-text review, and seven were finally included. Critical appraisal was independently conducted by two reviewers using the Joanna Briggs Institute appraisal checklists; no articles were excluded following critical appraisal. Data extraction was performed using Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument data extraction instruments. High heterogeneity between the studies precluded meta-analysis of the results; a narrative synthesis was completed instead. Two RCTs, two pseudo-RCTs, two repeated measures studies, and one case report were included. Studies varied in regard to participants' intellectual disability, and the clinical interventions used. Interventions were well tolerated with negligible adverse effects. Significant improvements were reported for

Strategies for prevention of postoperative delirium: a systematic review and meta-analysis of randomized trials

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2013-01-01

Introduction The ideal measures to prevent postoperative delirium remain unestablished. We conducted this systematic review and meta-analysis to clarify the significance of potential interventions. Methods The PRISMA statement guidelines were followed. Two researchers searched MEDLINE, EMBASE, CINAHL and the Cochrane Library for articles published in English before August 2012. Additional sources included reference lists from reviews and related articles from 'Google Scholar'. Randomized clinical trials (RCTs) on interventions seeking to prevent postoperative delirium in adult patients were included. Data extraction and methodological quality assessment were performed using predefined data fields and scoring system. Meta-analysis was accomplished for studies that used similar strategies. The primary outcome measure was the incidence of postoperative delirium. We further tested whether interventions effective in preventing postoperative delirium shortened the length of hospital stay. Results We identified 38 RCTs with interventions ranging from perioperative managements to pharmacological, psychological or multicomponent interventions. Meta-analysis showed dexmedetomidine sedation was associated with less delirium compared to sedation produced by other drugs (two RCTs with 415 patients, pooled risk ratio (RR) = 0.39; 95% confidence interval (CI) = 0.16 to 0.95). Both typical (three RCTs with 965 patients, RR = 0.71; 95% CI = 0.54 to 0.93) and atypical antipsychotics (three RCTs with 627 patients, RR = 0.36; 95% CI = 0.26 to 0.50) decreased delirium occurrence when compared to placebos. Multicomponent interventions (two RCTs with 325 patients, RR = 0.71; 95% CI = 0.58 to 0.86) were effective in preventing delirium. No difference in the incidences of delirium was found between: neuraxial and general anesthesia (four RCTs with 511 patients, RR = 0.99; 95% CI = 0.65 to 1.50); epidural and intravenous analgesia (three RCTs with 167 patients, RR = 0.93; 95% CI = 0.61 to 1

A review of the use of mobile phone text messaging in clinical and healthy behaviour interventions.

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Wei, Jin; Hollin, Ilene; Kachnowski, Stan

2011-01-01

We reviewed the literature on the use of text messaging for clinical and healthy behaviour interventions. Electronic databases were searched in December 2009 using keywords related to text messaging and health interventions. The final review included 24 articles. Of those, seven covered medication adherence, eight discussed clinical management and nine reported on health-related behaviour modification. Sixteen were randomized controlled trials (RCT), five were non-controlled pre-post comparison studies and three were feasibility pilots not reporting a behavioural outcome. The frequency of messaging ranged from multiple messages daily to one message per month. Among the 16 RCTs, 10 reported significant improvement with interventions and six reported differences suggesting positive trends. Text messaging received good acceptance and showed early efficacy in most studies. However, the evidence base is compromised by methodological limitations and is not yet conclusive.

Interventions for primary (intrinsic tracheomalacia in children

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Vikas Goyal

Full Text Available BACKGROUNDTracheomalacia, a disorder of the large airways where the trachea is deformed or malformed during respiration, is commonly seen in tertiary paediatric practice. It is associated with a wide spectrum of respiratory symptoms from life-threatening recurrent apnoea to common respiratory symptoms such as chronic cough and wheeze. Current practice following diagnosis of tracheomalacia includes medical approaches aimed at reducing associated symptoms of tracheomalacia, ventilation modalities of continuous positive airway pressure (CPAP and bi-level positive airway pressure (BiPAP, and surgical approaches aimed at improving the calibre of the airway (airway stenting, aortopexy, tracheopexy.OBJECTIVESTo evaluate the efficacy of medical and surgical therapies for children with intrinsic (primary tracheomalacia.METHODSSearchThe Cochrane Airways Group searched the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Airways Group's Specialized Register, Medline and Embase databases. The Cochrane Airways Group performed the latest searches in March 2012.Selection criteriaAll randomized controlled trials (RCTs of therapies related to symptoms associated with primary or intrinsic tracheomalacia.Data collection and analysisTwo reviewers extracted data from the included study independently and resolved disagreements by consensus.MAIN RESULTSWe included one RCT that compared nebulized recombinant human deoxyribonuclease (rhDNase with placebo in 40 children with airway malacia and a respiratory tract infection. We assessed it to be a RCT with overall low risk of bias. Data analyzed in this review showed that there was no significant difference between groups for the primary outcome of proportion cough-free at two weeks (odds ratio (OR 1.38; 95% confidence interval (CI 0.37 to 5.14. However, the mean change in night time cough diary scores significantly favoured the placebo group (mean difference (MD 1.00; 95% CI 0.17 to 1.83, P = 0

Evaluating brief motivational and self-regulatory hand hygiene interventions: a cross-over longitudinal design.

Science.gov (United States)

Lhakhang, Pempa; Lippke, Sonia; Knoll, Nina; Schwarzer, Ralf

2015-02-04

Frequent handwashing can prevent infections, but non-compliance to hand hygiene is pervasive. Few theory- and evidence-based interventions to improve regular handwashing are available. Therefore, two intervention modules, a motivational and a self-regulatory one, were designed and evaluated. In a longitudinal study, 205 young adults, aged 18 to 26 years, were randomized into two intervention groups. The Mot-SelfR group received first a motivational intervention (Mot; risk perception and outcome expectancies) followed by a self-regulatory intervention (SelfR; perceived self-efficacy and planning) 17 days later. The SelfR-Mot group received the same two intervention modules in the opposite order. Follow-up data were assessed 17 and 34 days after the baseline. Both intervention sequences led to an increase in handwashing frequency, intention, self-efficacy, and planning. Also, overall gains were found for the self-regulatory module (increased planning and self-efficacy levels) and the motivational module (intention). Within groups, the self-regulatory module appeared to be more effective than the motivational module, independent of sequence. Self-regulatory interventions can help individuals to exhibit more handwashing. Sequencing may be important as a motivation module (Mot) first helps to set the goal and a self-regulatory module (SelfR) then helps to translate this goal into actual behavior, but further research is needed to evaluate mechanisms.