Protocol for the saMS trial (supportive adjustment for multiple sclerosis: a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis

Directory of Open Access Journals (Sweden)

McCrone Paul

2009-08-01

Full Text Available Abstract Background Multiple Sclerosis (MS is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a Cognitive Behavioural intervention compared to Supportive Listening to assist adjustment in the early stages of MS. Methods/Design This is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks, mid-therapy (week 5 of therapy, post-therapy (15 weeks and at six months (26 weeks and twelve months (52 weeks follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants' experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place. Discussion This trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the

PRE-TRIAL SUPPORT OF YOUNG OFFENDERS (EFFECTIVENESS OF IMPLEMENTATION IN ARKHANGELSK REGION

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Yana Korneeva

2015-09-01

Full Text Available Sophisticated criminal situation with juvenile delinquency in Arkhangelsk region has prompted practitioners to find new ways to counteract. The basis for the acquisition of new knowledge in the field of prevention of juvenile delinquency was the phased introduction of social support for the pre-trial juvenile in conflict with the law. Based on the survey of investigators, investigators, judges and social workers involved in the experiment, the analysis of materials of criminal cases involving young offender’s conclusions about the positive results of the experiment revealed the difficulties and challenges faced by law enforcers. The article provides suggestions for optimizing the procedure of pre-trial support.

Initial Field Trial of a Coach-Supported Web-Based Depression Treatment.

Science.gov (United States)

Schueller, Stephen M; Mohr, David C

2015-08-01

Early web-based depression treatments were often self-guided and included few interactive elements, instead focusing mostly on delivering informational content online. Newer programs include many more types of features. As such, trials should analyze the ways in which people use these sites in order to inform the design of subsequent sites and models of support. The current study describes of a field trial consisting of 9 patients with major depressive disorder who completed a 12-week program including weekly coach calls. Patients usage varied widely, however, patients who formed regular patterns tended to persist with the program for the longest. Future sites might be able to facilitate user engagement by designing features to support regular use and to use coaches to help establish patterns to increase long-term use and benefit.

Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

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Sawyer, Michael G; Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

2017-07-24

Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List-Short Form, Maternal Support Scale, Ages and Stages Questionnaire-Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of

Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.

Science.gov (United States)

Pencina, Michael J; Louzao, Darcy M; McCourt, Brian J; Adams, Monique R; Tayyabkhan, Rehbar H; Ronco, Peter; Peterson, Eric D

2016-02-01

There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity. Copyright © 2015 Elsevier Inc. All rights reserved.

SU-F-P-13: NRG Oncology Medical Physics Manpower Survey Quantifying Support Demands for Multi Institutional Clinical Trials

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Monroe, J [St. Anthony’s Cancer Center, St. Louis, MO (United States); Case Western Reserve University (United States); Boparai, K [ACR, Reston, VA (United States); Xiao, Y [University of Pennsylvania, Philadelphia, PA (United States); Followill, D [UT MD Anderson Cancer Center, Houston, TX (United States); Galvin, J [Thomas Jefferson University Hospital, Newtown, PA (United States); Sohn, J [Case Western University, Cleveland, OH (United States)

2016-06-15

Purpose: A survey was taken by NRG Oncology to assess Full Time Equivalent (FTE) contributions to multi institutional clinical trials by medical physicists.No current quantification of physicists’ efforts in FTE units associated with clinical trials is available. The complexity of multi-institutional trials increases with new technologies and techniques. Proper staffing may directly impact the quality of trial data and outcomes. The demands on physics time supporting clinical trials needs to be assessed. Methods: The NRG Oncology Medical Physicist Subcommittee created a sixteen question survey to obtain this FTE data. IROC Houston distributed the survey to their list of 1802 contact physicists. Results: After three weeks, 363 responded (20.1% response). 187 (51.5%) institutions reporting external beam participation were processed. There was a wide range in number of protocols active and supported at each institution. Of the 187 clinics, 134 (71.7%) participate in 0 to 10 trials, 28 (15%) in 11 to 20 trials, 10 (5.3%) in 21 to 30 trials, 9 (4.8%) had 40 to 75 trials. On average, physicist spent 2.7 hours (SD: 6.0) per week supervising or interacting with clinical trial staff. 1.25 hours (SD: 3.37), 1.83 hours (SD: 4.13), and 0.64 hours(SD: 1.13) per week were spent on patient simulation, reviewing treatment plans, and maintaining a DICOM server, respectively. For all protocol credentialing activities, physicist spent an average of 37.05 hours (SD: 96.94) yearly. To support dosimetrists, clinicians, and therapists, physicist spend on average 2.07 hours (SD: 3.52) per week just reading protocols. Physicist attended clinical trial meetings for on average 1.13 hours (SD: 1.85) per month. Conclusion: Responding physicists spend a nontrivial amount of time: 8.8 hours per week (0.22 FTE) supporting, on average, 9 active multi-institutional clinical trials.

New trends in processing and disposal of municipal and industrial sewage sludges. 8. Joint seminar `waste water technology` with exhibitor`s forum; Neue Trends bei der Behandlung und Entsorgung kommunaler und industrieller Klaerschlaemme. Achtes gemeinsames Seminar `Abwassertechnik` mit Ausstellerforum

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NONE

1997-12-31

The present conference proceedings handle all aspects of sewage sludge disposal: agricultural use of sewage sludge, processing in anaerobic reactors, composting, drain, drying, gasification, combustion, economical aspects, ecological aspects, building, design and operation of modern sludge treatment plants. (SR) [Deutsch] Der vorliegende Tagungsband behandelt alle Aspekte der Klaerschlammentsorgung: landwirtschaftliche Nutzung von Klaerschlamm, Behandlung in Anaerobreaktoren, Kompostierung, Entwaesserung, Trocknung, Vergasung, Verbrennung, wirtschaftliche Aspekte, oekologische Aspekte, Bau, Ausruestung und Betrieb von modernen Schlammbehandlungsanlagen. (SR)

Postpartum depression peer support: maternal perceptions from a randomized controlled trial.

Science.gov (United States)

Dennis, Cindy-Lee

2010-05-01

Peer support in the early postpartum period is effective in the prevention of postpartum depression among women identified as high-risk. To describe maternal perceptions of peer support received while participating in a trial. Cross-sectional survey of women participating in a randomized controlled trial to evaluate the effect of peer support in the prevention of postpartum depression. Seven health regions across Ontario Canada. 701 women were recruited between November 2004 and September 2006. Women eligible for the study were all mothers with an Edinburgh Postnatal Depression Scale score >9 who were within 2 weeks postpartum, at least 18 years of age, able to speak English, had a live birth, and had been discharged home from the hospital. Exclusion criteria included an infant not discharged home with the mother and current use of antidepressant or antipsychotic medication. Two hundred and twenty-one mothers completed the mailed questionnaire. Women were randomly allocated to receive usual postpartum care (control group) or usual postpartum care plus telephone-based peer support (intervention group). Maternal perceptions of peer support were evaluated at 12 weeks postpartum using the validated Peer Support Evaluation Inventory. Interactions provided by the peer volunteer included the provision of emotional (92.7%), informational (72.4%), and appraisal (72.0%) support. Mothers reported high levels of positive relationship qualities such as trust (83.6%) and perceived acceptance (79.1%). Most (80.5%) mothers indicated they were very satisfied with their peer support experience. Maternal satisfaction was associated with the number and duration of peer volunteer contacts. The majority of mothers perceived their peer volunteer experience positively lending further support to telephone-based peer support as a preventative strategy for postpartum depression. The following program modifications were suggested: (a) adapt training to enhance the provision of appraisal

Lactation support and breastfeeding duration in jaundiced infants: a randomized controlled trial.

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Catherine M Pound

Full Text Available Neonatal jaundice is the most common problem in full-term infants during the immediate post-natal period. We examined the effect of a lactation support intervention on breastfeeding duration in hospitalized jaundiced infants.We conducted a randomized controlled trial with a qualitative component involving mothers of hospitalized jaundiced breastfed infants <4 weeks of age. Mothers receiving the intervention met with an International Board-Certified Lactation Consultant in hospital and 1-3 times post discharge. Both groups received the standard care for jaundice. The primary outcome was exclusive breastfeeding at 3 months. To the exception of research assistants enrolling participants and completing qualitative interviews, all research staff, investigators and statisticians were blinded to group assignment. Qualitative interviews elicited feedback on breastfeeding experiences for both groups.99 participants were recruited, and 86 analyzed for primary outcome. There was no difference in exclusive breastfeeding at 3 months between groups (RR 0.84, 95% CI 0.56-1.24, p = 0.40 or in the secondary outcomes. 31 participants were included in the qualitative analysis. Participants in the intervention group described an increase in comfort and confidence levels with breastfeeding. Participants in the control group reported limited lactation support.Our hospital-based lactation support program did not result in a higher proportion of mothers exclusively breastfeeding at 3 months compared to current hospital standard care. Qualitative feedback from the intervention group suggests that mothers' confidence was increased, which is linked to breastfeeding duration. The decision to breastfeed is multifactorial and hospital-based lactation support may be only a small piece of the puzzle in hospitalized jaundiced infants. Further studies may be needed to fully elucidate the impact of an in-hospital lactation support program on successful breastfeeding for these

Incorporating a Static Versus Supportive Mobile Phone App Into a Partial Meal Replacement Program With Face-to-Face Support: Randomized Controlled Trial.

Science.gov (United States)

Brindal, Emily; Hendrie, Gilly A; Freyne, Jill; Noakes, Manny

2018-04-18

Mobile phone apps may be acceptable to users and could improve retention and adherence over more traditional methods, but there is mixed literature supporting their efficacy. In the weight management space, very little is known about how a mobile phone app integrating features beyond text messaging (short message service) can affect behavior, particularly when combined with face-to-face support. The objective of this study was to examine the effectiveness of a mobile phone app when combined with a partial meal replacement program including face-to-face support. This paper compares a static versus supportive app over a 6-month randomized trial for effects on weight loss, weight-related biomarkers, and psychological outcomes. Overweight and obese adults (71.2% female, 104/146; mean 48.11, SD 11.75 years) were recruited to participate in the weight loss study, and they were randomized on a 1:1 basis using a computer algorithm. The supportive app (n=75) provided information, food intake recording, rewards, prompts for regular interaction through reminders, and the opportunity to review personal compliance with the dietary program. The static app (n=71) included only recipes and weight loss information. Both groups recieved equal amounts of face-to-face support in addition to app. The overall reduction in app usage over 24 weeks was lower for the supportive app in comparison with the static app; approximately 39.0% (57/146) of the users were still using the app at week 24. Despite the promising results for app usage, there were no differences in weight loss between groups (F1,128.12=0.83, P=.36). However, it should be noted that almost 60% (49/84) of all participants lost 5% or more of body weight during the trial. No weight-related biomarkers were significantly different between groups. Both groups experienced an increase in positive mood, but this was significantly higher for those who received the static app (F1,118.12=4.93, P=.03). Although the supportive app was

Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial

Directory of Open Access Journals (Sweden)

Golant Mitch

2011-08-01

Full Text Available Abstract Background The Internet can increase access to psychosocial care for breast cancer survivors through online support groups. This study will test a novel prosocial online group that emphasizes both opportunities for getting and giving help. Based on the helper therapy principle, it is hypothesized that the addition of structured helping opportunities and coaching on how to help others online will increase the psychological benefits of a standard online group. Methods/Design A two-armed randomized controlled trial with pretest and posttest. Non-metastatic breast cancer survivors with elevated psychological distress will be randomized to either a standard facilitated online group or to a prosocial facilitated online group, which combines online exchanges of support with structured helping opportunities (blogging, breast cancer outreach and coaching on how best to give support to others. Validated and reliable measures will be administered to women approximately one month before and after the interventions. Self-esteem, positive affect, and sense of belonging will be tested as potential mediators of the primary outcomes of depressive/anxious symptoms and sense of purpose in life. Discussion This study will test an innovative approach to maximizing the psychological benefits of cancer online support groups. The theory-based prosocial online support group intervention model is sustainable, because it can be implemented by private non-profit or other organizations, such as cancer centers, which mostly offer face-to-face support groups with limited patient reach. Trial Registration ClinicalTrials.gov: NCT01396174

Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study.

Science.gov (United States)

Lundh, Andreas; Barbateskovic, Marija; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

2010-10-26

transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue. we sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, we identified randomised trials published in 1996-1997 and 2005-2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005-2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005-2006. publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.

Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study.

Directory of Open Access Journals (Sweden)

Andreas Lundh

2010-10-01

Full Text Available BACKGROUND: transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue. METHODS AND FINDINGS: we sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]. For each journal, we identified randomised trials published in 1996-1997 and 2005-2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005-2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005-2006. CONCLUSIONS: publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.

High response rates following paclitaxel/5-FU and simultaneous radiotherapy in advanced head and neck carcinoma; Hohe Remissionsraten unter simultaner Radio- und Chemotherapie mit Paclitaxel/5-FU in der Behandlung fortgeschrittener Kopf-Hals-Tumoren

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Schroeder, M.; Westerhausen, M. [St.-Johannes-Hospital, Duisburg (Germany). Medizinische Klinik II; Makoski, H.B. [Staedtische Kliniken, Duisburg (Germany). Radioonkologie; Sesterhenn, K. [St. Anna-Krankenhaus, Duisburg (Germany). HNO-Klinik; Schroeder, R. [Bristol Myers Squibb, Muenchen (Germany). Dept. of Oncology

1997-11-01

The main stay of treatment for head and neck cancer patients with advanced disease has been chemotherapy with Cisplatin/5-FU and simultaneous applied radiotherapy. With this multimodality treatment including radical surgery after two cycles of neoadjuvant chemotherapy and 40 Gy radiotherapy we reported 60% complete remission after 5 years for patients with stage III/IV of head and neck cancer. Paclitaxel, a new plant product, has demonstrated significant antineoplastic activity in head and neck tumors (ECOG-Study: 40% RR). Therefore we performed a trial with Taxol/5-FU and simultaneous radiation in a neoadjuvant and postoperative adjuvant setting of stage III/IV squamous cell carcinoma of the head and neck with pre-existent contraindication against Cisplatin. Patients and Methods: 30 patients with a primarily inoperable stage III/IV of SCC of the head and neck were enrolled to receive day 1 and 29 Taxol 175 mg/m{sup 2} as a 3-hour-infusion, followed by 120-hour-cvi of 1000 mg/m{sup 2}/d 5-FU. Locally irradiation was given ad 40 Gy (2 Gy/d/day 1-26). Radical surgery followed about day 56. Postoperatively patients received again 2 cycles of Taxol/5-FU and simultaneous irradiation with 30 Gy. Results: So far 30 patients were treated and all patients reached a CR after complete treatment, ongoing for 23/30 patients for 6 till 34 months: 4 patients developed a second neoplasia, and 3 patients gloved a local relapse. The principal toxicity was moderate (neutropenia, peripheral neuropathy, arthralgia/myalgia) and sensible with supportive care (e.g. PEG). Conclusions: The results suggest that the treatment of SCC of the head and neck with Taxol/5-FU and simultaneous radiation and radical surgery is a highly effective schedule and comparable with the treatment with Cisplatin/5-FU. (orig.) [Deutsch] Der Standard in der Behandlung weit forgeschrittener, primaer inoperabler Kopf-Hals-Tumoren stellte die Cisplatinhaltige Chemotherapiekombination mit 5-FU dar mit simultan

Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study.

Science.gov (United States)

Gattrell, William T; Hopewell, Sally; Young, Kate; Farrow, Paul; White, Richard; Wager, Elizabeth; Winchester, Christopher C

2016-02-21

Authors may choose to work with professional medical writers when writing up their research for publication. We examined the relationship between medical writing support and the quality and timeliness of reporting of the results of randomised controlled trials (RCTs). Cross-sectional study. Primary reports of RCTs published in BioMed Central journals from 2000 to 16 July 2014, subdivided into those with medical writing support (n=110) and those without medical writing support (n=123). Proportion of items that were completely reported from a predefined subset of the Consolidated Standards of Reporting Trials (CONSORT) checklist (12 items known to be commonly poorly reported), overall acceptance time (from manuscript submission to editorial acceptance) and quality of written English as assessed by peer reviewers. The effect of funding source and publication year was examined. The number of articles that completely reported at least 50% of the CONSORT items assessed was higher for those with declared medical writing support (39.1% (43/110 articles); 95% CI 29.9% to 48.9%) than for those without (21.1% (26/123 articles); 95% CI 14.3% to 29.4%). Articles with declared medical writing support were more likely than articles without such support to have acceptable written English (81.1% (43/53 articles); 95% CI 67.6% to 90.1% vs 47.9% (23/48 articles); 95% CI 33.5% to 62.7%). The median time of overall acceptance was longer for articles with declared medical writing support than for those without (167 days (IQR 114.5-231 days) vs 136 days (IQR 77-193 days)). In this sample of open-access journals, declared professional medical writing support was associated with more complete reporting of clinical trial results and higher quality of written English. Medical writing support may play an important role in raising the quality of clinical trial reporting. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go

Siloxides as supporting ligands in uranium(III)-mediated small-molecule activation

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Mougel, Victor; Camp, Clement; Pecaut, Jacques; Mazzanti, Marinella [CEA-Grenoble (France). Lab. de Reconnaissance Ionique et Chimie de Coordination; Coperet, Christophe [ETH Zuerich (Switzerland). Lab. of Inorganic Chemistry; Maron, Laurent; Kefalidis, Christos E. [Toulouse Univ. (France). LPCNO, CNRS et INSA, UPS

2012-12-03

Siloxides support the reduction of small molecules with uranium complexes. The treatment of [U{N(SiMe_3)_2}{sub 3}] with HOSi(OtBu){sub 3} (3 equiv.) yielded a novel homoleptic uranium(III) siloxide complex 1, which acted as a two-electron reducing agent toward CS{sub 2} and CO{sub 2}. Uranium(III) siloxide complex 1 also reduced toluene to afford a diuranium inverted-sandwich complex. [German] Siloxide unterstuetzen die Reduktion kleiner Molekuele durch Uran-Komplexe. Die Behandlung von [U{N(SiMe_3)_2}{sub 3}] mit HOSi(OtBu){sub 3} (3 Aequiv.) liefert den neuartigen homoleptischen Uran(III)-Siloxid-Komplex 1, der als Zwei-Elektronen-Reduktionsmittel fuer CS{sub 2} und CO{sub 2} (siehe Schema) wirkt. Komplex 1 reduziert ausserdem Toluol und bildet einen invertierten Diuran-Sandwichkomplex.

The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial

Directory of Open Access Journals (Sweden)

Nakkash Rima

2011-08-01

Full Text Available Abstract Background Studies suggests a possible link between vaginal discharge and common mental distress, as well as highlight the implications of the subjective burden of disease and its link with mental health. Methods/Design This is a community-based intervention trial that aims to evaluate the impact of a psycho-social intervention on medically unexplained vaginal discharge (MUVD in a group of married, low-income Lebanese women, aged 18-49, and suffering from low to moderate levels of anxiety and/or depression. The intervention consisted of 12 sessions of structured social support, problem solving techniques, group discussions and trainer-supervised relaxation exercises (twice per week over six weeks. Women were recruited from Hey el Selloum, a southern disadvantaged suburb of Beirut, Lebanon, during an open recruitment campaign. The primary outcome was self-reported MUVD, upon ruling out reproductive tract infections (RTIs, through lab analysis. Anxiety and/or depression symptoms were the secondary outcomes for this trial. These were assessed using an Arabic validated version of the Hopkins Symptoms Checklist-25 (HSCL-25. Assessments were done at baseline and six months using face-to face interviews, pelvic examinations and laboratory tests. Women were randomized into either intervention or control group. Intent to treat analysis will be used. Discussion The results will indicate whether the proposed psychosocial intervention was effective in reducing MUVD (possibly mediated by common mental distress. Trial Registration The trial is registered at the Wellcome Trust Registry, ISRCTN assigned: ISRCTN: ISRCTN98441241

Protocol for the SEED-trial: Supported Employment and preventing Early Disability

Directory of Open Access Journals (Sweden)

Vigdis Sveinsdottir

2016-07-01

Full Text Available Abstract Background Early withdrawal or exclusion from the labor market leads to significant personal and societal costs. In Norway, the increasing numbers of young adults receiving disability pension is a growing problem. While a large body of research demonstrates positive effects of Supported Employment (SE in patients with severe mental illness, no studies have yet investigated the effectiveness of SE in young adults with a range of social and health conditions who are receiving benefits. Methods/design The SEED-trial is a randomized controlled trial (RCT comparing traditional vocational rehabilitation (TVR to SE in 124 unemployed individuals between the ages of 18-29 who are receiving benefits due to various social- or health-related problems. The primary outcome is labor market participation during the first year after enrollment. Secondary outcomes include physical and mental health, health behaviors, and well-being, collected at baseline, 6, and 12 months. A cost-benefit analysis will also be conducted. Discussion The SEED-trial is the first RCT to compare SE to TVR in this important and vulnerable group, at risk of being excluded from working life at an early age. Trial registration Clinicaltrials.gov, registration number NCT02375074 . Registered on December 3rd 2014

Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder

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Roberts Christopher

2011-07-01

Full Text Available Abstract Background Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years, and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. Methods/design Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. Discussion The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement. Trial Registration ISRCTN62761948 Funding National Institute for Health Research, England.

SU-F-T-237: The Imaging and Radiation Oncology Core (IROC) Cooperatives Activities Supporting the NCI’s National Clinical Trial Network

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Followill, D [UT MD Anderson Cancer Center, Houston, TX (United States); Galvin, J [Thomas Jefferson University Hospital, Newtown, PA (United States); Michalski, J [Washington University in St. Louis, St. Louis, MO (United States); Rosen, M [University of Pennsylvania Medical Center, Philadelphia, PA (United States); FitzGerald, T [University of Massachusetts Medical School, Lincoln, RI (United States); Knopp, M [The Ohio State University, Columbus, OH (United States)

2016-06-15

Purpose: The Imaging and Radiation Oncology Core (IROC) Cooperative has been active for the past two years supporting the National Clinical Trial Network and the details of that support are reported. Methods: There are six QA centers (Houston, Ohio, Philadelphia-RT, Philadelphia-DI, Rhode Island, St. Louis) providing an integrated RT and DI quality control program in support of the NCI’s clinical trials. The QA Center’s efforts are focused on assuring high quality data for clinical trials designed to improve the clinical outcomes for cancer patients worldwide. This program is administered through five core services: site qualification, trial design support, credentialing, data management, and case review. Results: IROC currently provides core support for 172 NCTN trials with RT, DI and RT/DI components. Many of these trials were legacy trial from the previous cooperative group program. IROC monitors nearly 1800 RT photon and 20 proton institutions. Over 28,000 beams outputs were monitored with 8% of the sites requiring repeat audits due to beam out of criteria. As part of credentialing, 950 QA phantoms have been irradiated, 515 imaging modalities evaluated and almost 4000 credentialing letters have been issued. In just year 2, 5290 RT and 4934 DI patient datasets were received (many using TRIAD) by IROC QA Centers to be prepared for review. During the past 2 years, a total of 6300 RT cases and 19,000 DI image sets were reviewed by IROC technical staff. To date, IROC has published 36 manuscripts. Conclusion: The QA services provided by IROC are numerous and are continually being evaluated for effectiveness, harmonized across all NCTN Groups and administered in an efficient and timely manner to enhance accurate and per protocol trial data submission. These efforts increase each NCTN Group’s ability to derive meaningful outcomes from their clinical trials. This work was supported by DHHS NIH grant 5U24CA180803.

Data-Driven Decision Support for Radiologists: Re-using the National Lung Screening Trial Dataset for Pulmonary Nodule Management

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Morrison, James J.; Hostetter, Jason; Wang, Kenneth; Siegel, Eliot L.

2014-01-01

Real-time mining of large research trial datasets enables development of case-based clinical decision support tools. Several applicable research datasets exist including the National Lung Screening Trial (NLST), a dataset unparalleled in size and scope for studying population-based lung cancer screening. Using these data, a clinical decision support tool was developed which matches patient demographics and lung nodule characteristics to a cohort of similar patients. The NLST dataset was conve...

Protocol for the SEED-trial: Supported Employment and preventing Early Disability.

Science.gov (United States)

Sveinsdottir, Vigdis; Tveito, Torill Helene; Bond, Gary R; Grasdal, Astrid Louise; Lie, Stein Atle; Reme, Silje Endresen

2016-07-15

Early withdrawal or exclusion from the labor market leads to significant personal and societal costs. In Norway, the increasing numbers of young adults receiving disability pension is a growing problem. While a large body of research demonstrates positive effects of Supported Employment (SE) in patients with severe mental illness, no studies have yet investigated the effectiveness of SE in young adults with a range of social and health conditions who are receiving benefits. The SEED-trial is a randomized controlled trial (RCT) comparing traditional vocational rehabilitation (TVR) to SE in 124 unemployed individuals between the ages of 18-29 who are receiving benefits due to various social- or health-related problems. The primary outcome is labor market participation during the first year after enrollment. Secondary outcomes include physical and mental health, health behaviors, and well-being, collected at baseline, 6, and 12 months. A cost-benefit analysis will also be conducted. The SEED-trial is the first RCT to compare SE to TVR in this important and vulnerable group, at risk of being excluded from working life at an early age. Clinicaltrials.gov, registration number NCT02375074 . Registered on December 3rd 2014.

A multi-site randomised controlled trial of evidence-based supported employment for adults with severe and persistent mental illness.

Science.gov (United States)

Waghorn, Geoffrey; Dias, Shannon; Gladman, Beverley; Harris, Meredith; Saha, Sukanta

2014-12-01

The Individual Placement and Support (IPS) approach is an evidence-based form of supported employment for people with severe and persistent mental illness. This approach is not yet widely available in Australia even though there is mounting evidence of its generalisability outside the USA. One previous Australian randomised controlled trial found that IPS is effective for young people with first episode psychosis. The aim of the current trial was to assess the effectiveness of evidence-based supported employment when implemented for Australian adult consumers of public mental health services by utilising existing service systems. A four-site randomised control trial design (n = 208) was conducted in Brisbane (two sites), Townsville and Cairns. The intervention consisted of an IPS supported employment service hosted by a community mental health team. The control condition was delivered at each site by mental health teams referring consumers to other disability employment services in the local area. At 12 months, those in the IPS condition had 2.4 times greater odds of commencing employment than those in the control condition (42.5% vs. 23.5%). The conditions did not differ on secondary employment outcomes including job duration, hours worked, or job diversity. Attrition was higher than expected in both conditions with 28.4% completing the baseline interview but taking no further part in the study. The results support previous international findings that IPS-supported employment is more effective than non-integrated supported employment. IPS can be successfully implemented this way in Australia, but with a loss of effect strength compared to previous USA trials. © 2014 Occupational Therapy Australia.

Evidence-Based Literacy Support: The "Literacy Octopus" Trial. Evaluation Report and Executive Summary

Science.gov (United States)

Lord, Pippa; Rabiasz, Adam; Roy, Palak; Harland, Jennie; Styles, Ben; Fowler, Katherine

2017-01-01

The Evidence-based Literacy Support-"Literacy Octopus" Trial tested a range of dissemination interventions and resources, all of which aimed to engage schools in using evidence-based materials to improve teaching and learning in Key Stage 2 literacy. Four delivery partners provided interventions. These included light-touch,…

The ANKLE TRIAL (ANKLE treatment after injuries of the ankle ligaments: what is the benefit of external support devices in the functional treatment of acute ankle sprain? : a randomised controlled trial

Directory of Open Access Journals (Sweden)

Witjes Suzanne

2012-02-01

Full Text Available Abstract Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180 with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales, number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR: NTR2151

The ANKLE TRIAL (ANKLE treatment after injuries of the ankle ligaments): what is the benefit of external support devices in the functional treatment of acute ankle sprain? : a randomised controlled trial

Science.gov (United States)

2012-01-01

Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180) with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales), number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR): NTR2151 PMID:22340371

Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

Science.gov (United States)

Cabassa, Leopoldo J; Stefancic, Ana; O'Hara, Kathleen; El-Bassel, Nabila; Lewis-Fernández, Roberto; Luchsinger, José A; Gates, Lauren; Younge, Richard; Wall, Melanie; Weinstein, Lara; Palinkas, Lawrence A

2015-09-02

The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese. The Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial. This paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI. www

Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR.

Science.gov (United States)

McCowan, Colin; Thomson, Elizabeth; Szmigielski, Cezary A; Kalra, Dipak; Sullivan, Frank M; Prokosch, Hans-Ulrich; Dugas, Martin; Ford, Ian

2015-01-01

The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.

Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR

Directory of Open Access Journals (Sweden)

Colin McCowan

2015-01-01

Full Text Available Background. The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. Methods. Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. Results. 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. Conclusions. There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.

A Trial of Telephone Support Services to Prevent Further Intimate Partner Violence.

Science.gov (United States)

Stevens, Jack; Scribano, Philip V; Marshall, Jessica; Nadkarni, Radha; Hayes, John; Kelleher, Kelly J

2015-12-01

We conducted a randomized-controlled trial of telephone support services (TSS) versus enhanced usual care (EUC) for women who had reported intimate partner violence (IPV) within the past year during a visit to a pediatric emergency department. TSS nurse interventionists identified appropriate referrals to community programs, helped participants by problem-solving barriers to obtaining these local services, and provided social support. Three hundred women, ages 18 years and above were recruited. The TSS and EUC groups did not differ on any outcome variable, including IPV victimization, feelings of chronic vulnerability to a perpetrator, depressive symptoms, and posttraumatic stress disorder symptoms. © The Author(s) 2015.

Effects of Natural Sounds on Pain: A Randomized Controlled Trial with Patients Receiving Mechanical Ventilation Support.

Science.gov (United States)

Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Vaismoradi, Mojtaba; Jordan, Sue

2015-08-01

Nonpharmacologic pain management in patients receiving mechanical ventilation support in critical care units is under investigated. Natural sounds may help reduce the potentially harmful effects of anxiety and pain in hospitalized patients. The aim of this study was to examine the effect of pleasant, natural sounds on self-reported pain in patients receiving mechanical ventilation support, using a pragmatic parallel-arm, randomized controlled trial. The study was conducted in a general adult intensive care unit of a high-turnover teaching hospital, in Tehran, Iran. Between October 2011 and June 2012, we recruited 60 patients receiving mechanical ventilation support to the intervention (n = 30) and control arms (n = 30) of a pragmatic parallel-group, randomized controlled trial. Participants in both arms wore headphones for 90 minutes. Those in the intervention arm heard pleasant, natural sounds, whereas those in the control arm heard nothing. Outcome measures included the self-reported visual analog scale for pain at baseline; 30, 60, and 90 minutes into the intervention; and 30 minutes post-intervention. All patients approached agreed to participate. The trial arms were similar at baseline. Pain scores in the intervention arm fell and were significantly lower than in the control arm at each time point (p natural sounds via headphones is a simple, safe, nonpharmacologic nursing intervention that may be used to allay pain for up to 120 minutes in patients receiving mechanical ventilation support. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Pressure relieving support surfaces (PRESSURE) trial: cost effectiveness analysis.

Science.gov (United States)

Iglesias, Cynthia; Nixon, Jane; Cranny, Gillian; Nelson, E Andrea; Hawkins, Kim; Phillips, Angela; Torgerson, David; Mason, Su; Cullum, Nicky

2006-06-17

To assess the cost effectiveness of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers in patients admitted to hospital. Cost effectiveness analysis carried out alongside the pressure relieving support surfaces (PRESSURE) trial; a multicentre UK based pragmatic randomised controlled trial. 11 hospitals in six UK NHS trusts. Intention to treat population comprising 1971 participants. Kaplan Meier estimates of restricted mean time to development of pressure ulcers and total costs for treatment in hospital. Alternating pressure mattresses were associated with lower overall costs (283.6 pounds sterling per patient on average, 95% confidence interval--377.59 pounds sterling to 976.79 pounds sterling) mainly due to reduced length of stay in hospital, and greater benefits (a delay in time to ulceration of 10.64 days on average,--24.40 to 3.09). The differences in health benefits and total costs for hospital stay between alternating pressure mattresses and alternating pressure overlays were not statistically significant; however, a cost effectiveness acceptability curve indicated that on average alternating pressure mattresses compared with alternating pressure overlays were associated with an 80% probability of being cost saving. Alternating pressure mattresses for the prevention of pressure ulcers are more likely to be cost effective and are more acceptable to patients than alternating pressure overlays.

Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial.

Science.gov (United States)

Lepore, Stephen J; Buzaglo, Joanne S; Lieberman, Morton A; Golant, Mitch; Davey, Adam

2011-08-25

The Internet can increase access to psychosocial care for breast cancer survivors through online support groups. This study will test a novel prosocial online group that emphasizes both opportunities for getting and giving help. Based on the helper therapy principle, it is hypothesized that the addition of structured helping opportunities and coaching on how to help others online will increase the psychological benefits of a standard online group. A two-armed randomized controlled trial with pretest and posttest. Non-metastatic breast cancer survivors with elevated psychological distress will be randomized to either a standard facilitated online group or to a prosocial facilitated online group, which combines online exchanges of support with structured helping opportunities (blogging, breast cancer outreach) and coaching on how best to give support to others. Validated and reliable measures will be administered to women approximately one month before and after the interventions. Self-esteem, positive affect, and sense of belonging will be tested as potential mediators of the primary outcomes of depressive/anxious symptoms and sense of purpose in life. This study will test an innovative approach to maximizing the psychological benefits of cancer online support groups. The theory-based prosocial online support group intervention model is sustainable, because it can be implemented by private non-profit or other organizations, such as cancer centers, which mostly offer face-to-face support groups with limited patient reach. ClinicalTrials.gov: NCT01396174.

Chemistry, manufacturing and control (CMC) and clinical trial technical support for influenza vaccine manufacturers.

Science.gov (United States)

Wahid, Rahnuma; Holt, Renee; Hjorth, Richard; Berlanda Scorza, Francesco

2016-10-26

With the support of the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, PATH has contributed to the World Health Organization's (WHO's) Global Action Plan for Influenza Vaccines (GAP) by providing technical and clinical assistance to several developing country vaccine manufacturers (DCVMs). GAP builds regionally based independent and sustainable influenza vaccine production capacity to mitigate the overall global shortage of influenza vaccines. The program also ensures adequate influenza vaccine manufacturing capacity in the event of an influenza pandemic. Since 2009, PATH has worked closely with two DCVMs in Vietnam: the Institute of Vaccines and Medical Biologicals (IVAC) and VABIOTECH. Beginning in 2013, PATH also began working with Torlak Institute in Serbia; Instituto Butantan in Brazil; Serum Institute of India Private Ltd. in India; and Changchun BCHT Biotechnology Co. (BCHT) in China. The DCVMs supported under the GAP program all had existing influenza vaccine manufacturing capability and required technical support from PATH to improve vaccine yield, process efficiency, and product formulation. PATH has provided customized technical support for the manufacturing process to each DCVM based on their respective requirements. Additionally, PATH, working with BARDA and WHO, supported several DCVMs in the clinical development of influenza vaccine candidates progressing toward national licensure or WHO prequalification. As a result of the activities outlined in this review, several companies were able to make excellent progress in developing state-of-the-art manufacturing processes and completing early phase clinical trials. Licensure trials are currently ongoing or planned for several DCVMs. Copyright © 2016 Elsevier Ltd. All rights reserved.

PhysioDirect: Supporting physiotherapists to deliver telephone assessment and advice services within the context of a randomised trial

Science.gov (United States)

Bishop, Annette; Gamlin, Jill; Hall, Jeanette; Hopper, Cherida; Foster, Nadine E.

2013-01-01

Physiotherapy-led telephone assessment and advice services for patients with musculoskeletal problems have been developed in many services in the UK, but high quality trial data on clinical and cost effectiveness has been lacking. In order to address this ‘The PhysioDirect trial’ (ISRCTN55666618), was a pragmatic randomised trial of a PhysioDirect telephone assessment and advice service. This paper describes the PhysioDirect system used in the trial and how physiotherapists were trained and supported to use the system and deliver the PhysioDirect service. The PhysioDirect system used in the trial was developed in Huntingdon and now serves a population of 350,000 people. When initiating or providing physiotherapy-led telephone assessment and advice services training and support for physiotherapists delivering care in this way is essential. An enhanced skill set is required for telephone assessment and advice particularly in listening and communication skills. In addition to an initial training programme, even experienced physiotherapists benefit from a period of skill consolidation to become proficient and confident in assessing patients and delivering care using the telephone. A computer-based system assists the delivery of a physiotherapy-led musculoskeletal assessment and advice service. Clinical Trials Registration Number (ISRCTN55666618). PMID:23219629

Clinical Trials

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Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

Randomized Trial of a Smartphone Mobile Application Compared to Text Messaging to Support Smoking Cessation

OpenAIRE

Buller, David B.; Borland, Ron; Bettinghaus, Erwin P.; Shane, James H.; Zimmerman, Donald E.

2014-01-01

Background: Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Materials and Methods: Young adult smokers 18–30 years old (n=102) participated in a randomized pretest–posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and qu...

Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial.

Science.gov (United States)

Dobson, Rosie; Whittaker, Robyn; Jiang, Yannan; Shepherd, Matthew; Maddison, Ralph; Carter, Karen; Cutfield, Richard; McNamara, Catherine; Khanolkar, Manish; Murphy, Rinki

2016-04-02

Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlines the rationale and methods of the trial. A two-arm, parallel, randomised controlled trial will be conducted across New Zealand health districts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based and individually tailored automated text message-based diabetes self-management support programme (intervention) in addition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at 9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours, diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction. This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes. If found to be effective it has the potential to provide individualised support to people with diabetes across New Zealand (and

Protocol for SAMS (Support and Advice for Medication Study: A randomised controlled trial of an intervention to support patients with type 2 diabetes with adherence to medication

Directory of Open Access Journals (Sweden)

Sutton Stephen

2008-04-01

Full Text Available Abstract Background Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design. Methods and Design The SAMS (Supported Adherence to Medication Study trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation

Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial.

Science.gov (United States)

Bucknall, C E; Miller, G; Lloyd, S M; Cleland, J; McCluskey, S; Cotton, M; Stevenson, R D; Cotton, P; McConnachie, A

2012-03-06

To determine whether supported self management in chronic obstructive pulmonary disease (COPD) can reduce hospital readmissions in the United Kingdom. Randomised controlled trial. Community based intervention in the west of Scotland. Patients admitted to hospital with acute exacerbation of COPD. Participants in the intervention group were trained to detect and treat exacerbations promptly, with ongoing support for 12 months. The primary outcome was hospital readmissions and deaths due to COPD assessed by record linkage of Scottish Morbidity Records; health related quality of life measures were secondary outcomes. 464 patients were randomised, stratified by age, sex, per cent predicted forced expiratory volume in 1 second, recent pulmonary rehabilitation attendance, smoking status, deprivation category of area of residence, and previous COPD admissions. No difference was found in COPD admissions or death (111/232 (48%) v 108/232 (47%); hazard ratio 1.05, 95% confidence interval 0.80 to 1.38). Return of health related quality of life questionnaires was poor (n=265; 57%), so that no useful conclusions could be made from these data. Pre-planned subgroup analysis showed no differential benefit in the primary outcome relating to disease severity or demographic variables. In an exploratory analysis, 42% (75/150) of patients in the intervention group were classified as successful self managers at study exit, from review of appropriateness of use of self management therapy. Predictors of successful self management on stepwise regression were younger age (P=0.012) and living with others (P=0.010). COPD readmissions/deaths were reduced in successful self managers compared with unsuccessful self managers (20/75 (27%) v 51/105 (49%); hazard ratio 0.44, 0.25 to 0.76; P=0.003). Supported self management had no effect on time to first readmission or death with COPD. Exploratory subgroup analysis identified a minority of participants who learnt to self manage; this group had a

Ethnography, fidelity, and the evidence that anthropology adds: supplementing the fidelity process in a clinical trial of supported employment.

Science.gov (United States)

Smith-Morris, Carolyn; Lopez, Gilberto; Ottomanelli, Lisa; Goetz, Lance; Dixon-Lawson, Kimberly

2014-06-01

This discussion considers the role and findings of ethnographic research within a clinical trial of supported employment for veterans with spinal cord injury. Contributing to qualitative evaluation research and to debates over anthropological evidence vis-à-vis clinical trials, we demonstrate how enactors of a randomized controlled trial can simultaneously attend to both the trial's evidentiary and procedural requirements and to the lived experiences and needs of patients and clinicians. Three major findings are described: (1) contextual information essential to fidelity efforts within the trial; (2) the role of human interrelationships and idiosyncratic networks in the trial's success; and (3) a mapping of the power and authority structures relevant to the staff's ability to perform the protocol. We emphasize strengths of anthropological ethnography in clinical trials that include the provision of complementary, qualitative data, the capture of otherwise unmeasured parts of the trial, and the realization of important information for the translation of the clinical findings into new settings. © 2014 by the American Anthropological Association.

Clinical Trials

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Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

A randomized controlled trial of community health workers using patient stories to support hypertension management: Study protocol.

Science.gov (United States)

Hargraves, J Lee; Bonollo, Debra; Person, Sharina D; Ferguson, Warren J

2018-04-12

Uncontrolled hypertension is a significant public health problem in the U.S. with about one half of people able to keep blood pressure (BP) under control. Uncontrolled hypertension leads to increased risk of stroke, heart attack, and death. Furthermore, the social and economic costs of poor hypertension control are staggering. People living with hypertension can benefit from additional educational outreach and support. This randomized trial conducted at two Community Health Centers (CHCs) in Massachusetts assessed the effect of community health workers (CHWs) assisting patients with hypertension. In addition to the support provided by CHWs, the study uses video narratives from patients who have worked to control their BP through diet, exercise, and better medication adherence. Participants enrolled in the study were randomly assigned to immediate intervention (I) by CHWs or a delayed intervention (DI) (4 to 6 months later). Each participant was asked to meet with the CHW 5 times (twice in person and three times telephonically). Study outcomes include systolic and diastolic BP, diet, exercise, and body mass index. CHWs working directly with patients, using multiple approaches to support patient self-management, can be effective agents to support change in chronic illness management. Moreover, having culturally appropriate tools, such as narratives available through videos, can be an important, cost effective aid to CHWs. Recruitment and intervention delivery within a busy CHC environment required adaptation of the study design and protocols for staff supervision, data collection and intervention delivery and lessons learned are presented. Clinical Trials.gov registration submitted 8/17/16: Protocol ID# 5P60MD006912-02 and Clinical trials.gov ID# NCT02874547 Community Health Workers Using Patient Stories to Support Hypertension Management. Copyright © 2018. Published by Elsevier Inc.

Remedial after-school support classes offered in rural Gambia (The SCORE trial): study protocol for a cluster randomized controlled trial.

Science.gov (United States)

Boone, Peter; Camara, Alpha; Eble, Alex; Elbourne, Diana; Fernandes, Samory; Frost, Chris; Jayanty, Chitra; Lenin, Maitri; Silva, Ana Filipa

2015-12-16

Low education levels are endemic in much of the developing world, particularly in rural areas where traditional government-provided public services often have difficulty reaching beneficiaries. Providing trained para-teachers to teach regular after-school remedial education classes has been shown to improve literacy and numeracy in children of primary school age residing in such areas in India. This trial investigates whether such an intervention can also be effective in a West African setting with similarly low learning levels and difficult geographic access. cluster-randomized controlled trial. Clusters: villages or groups of villages with 15-300 households and at least 15 eligible children in the Lower River and North Bank Regions of The Gambia. children born between 1 September 2007 and 31 August 2009 planning to enter the first grade, for the first time, in the 2015-2016 school year in eligible villages. We anticipate enrolling approximately 150 clusters of villages with approximately 6000 children as participants. a program providing remedial after-school lessons, focusing on literacy and numeracy, 5 to 6 days a week for 3 years to eligible children, based on the intervention evaluated in the Support To Rural India's Public Education System (STRIPES) trial (PLoS ONE 8(7):e65775). both the intervention and control groups will receive small bundles of useful materials during annual data collection as recompense for their time. If the education intervention is shown to be cost-effective at raising learning levels, it is expected that the control group villages will receive the intervention for several years after the trial results are available. the primary outcome of the trial is a composite mathematics and language test score. Secondary outcomes include school attendance, enrollment, performance on nationally administered exams, parents' spending on education, spillover learning to siblings and family members, and school-related time use of parents and

Discontinuation and non-publication of randomised clinical trials supported by the main public funding body in Switzerland: a retrospective cohort study.

Science.gov (United States)

Amstutz, Alain; Schandelmaier, Stefan; Frei, Roy; Surina, Jakub; Agarwal, Arnav; Olu, Kelechi Kalu; Alturki, Reem; Von Niederhäusern, Belinda; Von Elm, Erik; Briel, Matthias

2017-08-01

The Swiss National Science Foundation (SNSF) promotes academic excellence through competitive selection of study proposals and rigorous evaluation of feasibility, but completion status and publication history of SNSF-supported randomised clinical trials (RCTs) remain unclear. The main objectives were to review all healthcare RCTs supported by the SNSF for trial discontinuation and non-publication, to investigate potential risk factors for trial discontinuation due to poor recruitment and non-publication, and to compare findings to other Swiss RCTs not supported by the SNSF. We established a retrospective cohort of all SNSF-supported RCTs for which recruitment and funding had ended in 2015 or earlier. For each RCT, two investigators independently searched corresponding publications in electronic databases. In addition, we approached all principal investigators to ask for additional publications and information about trial discontinuation. Teams of two investigators independently extracted details about study design, recruitment of participants, outcomes, analysis and sample size from the original proposal and, if available, from trial registries and publications. We used multivariable regression analysis to explore potential risk factors associated with discontinuation due to poor recruitment and with non-publication, and to compare our results with data from a previous cohort of Swiss RCTs not supported by the SNSF. We included 101 RCTs supported by the SNSF between 1986 and 2015. Eighty-seven (86%) principal investigators responded to our survey. Overall, 69 (68%) RCTs were completed, 26 (26%) RCTs were prematurely discontinued (all due to slow recruitment) and the completion status remained unclear for 6 (6%) RCTs. For analysing publication status, we excluded 4 RCTs for which follow-up was still ongoing and 9 for which manuscripts were still in preparation. Of the remaining 88 RCTs, 53 (60%) were published as full articles in peer-reviewed journals

Data-driven decision support for radiologists: re-using the National Lung Screening Trial dataset for pulmonary nodule management.

Science.gov (United States)

Morrison, James J; Hostetter, Jason; Wang, Kenneth; Siegel, Eliot L

2015-02-01

Real-time mining of large research trial datasets enables development of case-based clinical decision support tools. Several applicable research datasets exist including the National Lung Screening Trial (NLST), a dataset unparalleled in size and scope for studying population-based lung cancer screening. Using these data, a clinical decision support tool was developed which matches patient demographics and lung nodule characteristics to a cohort of similar patients. The NLST dataset was converted into Structured Query Language (SQL) tables hosted on a web server, and a web-based JavaScript application was developed which performs real-time queries. JavaScript is used for both the server-side and client-side language, allowing for rapid development of a robust client interface and server-side data layer. Real-time data mining of user-specified patient cohorts achieved a rapid return of cohort cancer statistics and lung nodule distribution information. This system demonstrates the potential of individualized real-time data mining using large high-quality clinical trial datasets to drive evidence-based clinical decision-making.

Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial

DEFF Research Database (Denmark)

Beck, Anne Marie; Gøgsig Christensen, Annette; Stenbæk Hansen, Birthe

2014-01-01

BACKGROUND: Older adults in nursing home and home-care are a particularly high-risk population for weight loss or poor nutrition. One negative consequence of undernutrition is increased health care costs. Several potentially modifiable nutritional risk factors increase the likelihood of weight loss......-effectiveness of nutritional support among undernourished older adults and none of these have used such a multidisciplinary approach. METHODS: An 11 week cluster randomized trial to assess the cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home...... older adults in home-care and nursing home and contribute to important research. TRIAL REGISTRATION: ClinicalTrials.gov 2013 NCT01873456....

Cluster randomized controlled trial of a peer support program for people with diabetes: study protocol for the Australasian peers for progress study

Directory of Open Access Journals (Sweden)

Riddell Michaela A

2012-10-01

measures are collected on all participants at baseline, 6 and 12 months. The primary outcome is change in cardiovascular disease risk using the UKPDS risk equation. Secondary outcomes include biomedical, quality of life, psychosocial functioning, and other lifestyle measures. An economic evaluation will determine whether the program is cost effective. Discussion This manuscript presents the protocol for a cluster randomized controlled trial of group-based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes. Trial registration number Australian New Zealand Clinical Trials Registry (ANZCTR; ACTRN12609000469213

Supporting Policy In health with Research: an Intervention Trial (SPIRIT)—protocol for a stepped wedge trial

Science.gov (United States)

2014-01-01

Introduction Governments in different countries have committed to better use of evidence from research in policy. Although many programmes are directed at assisting agencies to better use research, there have been few tests of the effectiveness of such programmes. This paper describes the protocol for SPIRIT (Supporting Policy In health with Research: an Intervention Trial), a trial designed to test the effectiveness of a multifaceted programme to build organisational capacity for the use of research evidence in policy and programme development. The primary aim is to determine whether SPIRIT results in an increase in the extent to which research and research expertise is sought, appraised, generated and used in the development of specific policy products produced by health policy agencies. Methods and analysis A stepped wedge cluster randomised trial involving six health policy agencies located in Sydney, Australia. Policy agencies are the unit of randomisation and intervention. Agencies were randomly allocated to one of three start dates (steps) to receive the 1-year intervention programme, underpinned by an action framework. The SPIRIT intervention is tailored to suit the interests and needs of each agency and includes audit, feedback and goal setting; a leadership programme; staff training; the opportunity to test systems to assist in the use of research in policies; and exchange with researchers. Outcome measures will be collected at each agency every 6 months for 30 months (starting at the beginning of step 1). Ethics and dissemination Ethics approval was granted by the University of Western Sydney Human Research and Ethics Committee HREC Approval H8855. The findings of this study will be disseminated broadly through peer-reviewed publications and presentations at conferences and used to inform future strategies. PMID:24989620

Qualitative insights into implementation, processes, and outcomes of a randomized trial on peer support and HIV care engagement in Rakai, Uganda.

Science.gov (United States)

Monroe, April; Nakigozi, Gertrude; Ddaaki, William; Bazaale, Jeremiah Mulamba; Gray, Ronald H; Wawer, Maria J; Reynolds, Steven J; Kennedy, Caitlin E; Chang, Larry W

2017-01-10

People living with human immunodeficiency virus (HIV) who have not yet initiated antiretroviral therapy (ART) can benefit from being engaged in care and utilizing preventive interventions. Community-based peer support may be an effective approach to promote these important HIV services. After conducting a randomized trial of the impact of peer support on pre-ART outcomes, we conducted a qualitative evaluation to better understand trial implementation, processes, and results. Overall, 75 participants, including trial participants (clients), peer supporters, and clinic staff, participated in 41 in-depth interviews and 6 focus group discussions. A situated Information Motivation, and Behavioral skills model of behavior change was used to develop semi-structured interview and focus group guides. Transcripts were coded and thematically synthesized. We found that participant narratives were generally consistent with the theoretical model, indicating that peer support improved information, motivation, and behavioral skills, leading to increased engagement in pre-ART care. Clients described how peer supporters reinforced health messages and helped them better understand complicated health information. Peer supporters also helped clients navigate the health system, develop support networks, and identify strategies for remembering medication and clinic appointments. Some peer supporters adopted roles beyond visiting patients, serving as a bridge between the client and his or her family, community, and health system. Qualitative results demonstrated plausible processes by which peer support improved client engagement in care, cotrimoxazole use, and safe water vessel use. Challenges identified included insufficient messaging surrounding ART initiation, lack of care continuity after ART initiation, rare breaches in confidentiality, and structural challenges. The evaluation found largely positive perceptions of the peer intervention across stakeholders and provided valuable

Types of Cancer Clinical Trials

Science.gov (United States)

Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.

Lay support for pregnant women with social risk: a randomised controlled trial

Science.gov (United States)

Kenyon, Sara; Jolly, Kate; Hemming, Karla; Hope, Lucy; Blissett, Jackie; Dann, Sophie-Anna; Lilford, Richard; MacArthur, Christine

2016-01-01

Objectives We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families. Design Prospective, pragmatic, individually randomised controlled trial. Setting 3 Maternity Trusts in West Midlands, UK. Participants Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded. Interventions POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms. Main outcome measures Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8–12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8–12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems. Results Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) −0.00, 95% CI (95% CI −0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD −0.79 (95% CI −1.56 to −0.02) was significantly better, although for all women recruited, no significant differences were seen (MD −0.59 (95% CI −1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group

Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial.

Science.gov (United States)

Bobrow, Kirsten; Farmer, Andrew J; Springer, David; Shanyinde, Milensu; Yu, Ly-Mee; Brennan, Thomas; Rayner, Brian; Namane, Mosedi; Steyn, Krisela; Tarassenko, Lionel; Levitt, Naomi

2016-02-09

We assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure. In this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, interactive SMS text messaging, or usual care. The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012, and November 23, 2012, 1372 participants were randomized to receive information-only SMS text messages (n=457), interactive SMS text messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141. © 2016 American Heart Association, Inc.

Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial.

Science.gov (United States)

Bobrow, Kirsty; Brennan, Thomas; Springer, David; Levitt, Naomi S; Rayner, Brian; Namane, Mosedi; Yu, Ly-Mee; Tarassenko, Lionel; Farmer, Andrew

2014-01-11

Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care. The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data

Internet peer support for individuals with psychiatric disabilities: A randomized controlled trial.

Science.gov (United States)

Kaplan, Katy; Salzer, Mark S; Solomon, Phyllis; Brusilovskiy, Eugene; Cousounis, Pamela

2011-01-01

Despite the prevalence of Internet support groups for individuals with mental illnesses little is known about the potential benefits, or harm, of participating in such groups. Therefore, this randomized controlled trial sought to determine the impact of unmoderated, unstructured Internet peer support, similar to what is naturally occurring on the Internet, on the well-being of individuals with psychiatric disabilities. Three hundred individuals resident in the USA diagnosed with a Schizophrenia Spectrum or an Affective Disorder were randomized into one of three conditions: experimental Internet peer support via a listserv, experimental Internet peer support via a bulletin board, or a control condition. Three measurement time points, baseline, 4- and 12 months post-baseline, assessed well-being by examining measures of recovery, quality of life, empowerment, social support, and distress. Time × group interactions in the repeated measures ANOVA showed no differences between conditions on the main outcomes. Post-hoc repeated measures ANOVAs found that those individuals who participated more in Internet peer support reported higher levels of distress than those with less or no participation (p = 0.03). Those who reported more positive experiences with the Internet peer support group also reported higher levels of psychological distress than those reporting less positive experiences (p = 0.01). Study results therefore do not support the hypothesis that participation in an unmoderated, unstructured Internet listserv or bulletin board peer support group for individuals with psychiatric disabilities enhances well-being. Counterintuitive findings demonstrating those who report more positive experiences also experienced higher levels of distress are discussed but we also point to the need for additional research. Future research should explore the various structures, formats, and interventions of Internet support, as well as the content and quality of interactions

The Relaxation Exercise and Social Support Trial (RESST: a community-based randomized controlled trial to alleviate medically unexplained vaginal discharge symptoms

Directory of Open Access Journals (Sweden)

Kobeissi Loulou

2012-11-01

no evidence of mediation of the effect on MUVD through measures of common mental disorders. Conclusion This study confirms that MUVD is an important public health problem. While the benefits of this intervention may appear modest, the intervention offers an opportunity for women to enhance their problem-solving skills as well as use physical relaxation techniques that can help them deal with stressful in their lives. Further research is needed in a variety of contexts, for different populations and preferably involving larger randomized trials of such an intervention. Trial registration * Title of trial: The Relaxation Exercise and Social Support Trial ISRCTN assigned: ISRCTN98441241 Date of assignation: 10/09/2010 Link: http://www.controlled-trials.com/ISRCTN98441241 * Also registered at the Wellcome Trust register: http://www.controlled-trials.com/mrct/trial/469943/98441241

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial.

Science.gov (United States)

Brown, Sarah; Smith, Isabelle L; Brown, Julia M; Hulme, Claire; McGinnis, Elizabeth; Stubbs, Nikki; Nelson, E Andrea; Muir, Delia; Rutherford, Claudia; Walker, Kay; Henderson, Valerie; Wilson, Lyn; Gilberts, Rachael; Collier, Howard; Fernandez, Catherine; Hartley, Suzanne; Bhogal, Moninder; Coleman, Susanne; Nixon, Jane E

2016-12-20

Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual's functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and patient repositioning. The aim of the PRESSURE 2 study is to compare the two main mattress types utilised within the NHS: high-specification foam and alternating pressure mattresses, in the prevention of pressure ulcers. PRESSURE 2 is a multicentre, open-label, randomised, double triangular, group sequential, parallel group trial. A maximum of 2954 'high-risk' patients with evidence of acute illness will be randomised on a 1:1 basis to receive either a high-specification foam mattress or alternating-pressure mattress in conjunction with an electric profiling bed frame. The primary objective of the trial is to compare mattresses in terms of the time to developing a new Category 2 or above pressure ulcer by 30 days post end of treatment phase. Secondary endpoints include time to developing new Category 1 and 3 or above pressure ulcers, time to healing of pre-existing Category 2 pressure ulcers, health-related quality of life, cost-effectiveness, incidence of mattress change and safety. Validation objectives are to determine the responsiveness of the Pressure Ulcer Quality of Life-Prevention instrument and the feasibility of having a blinded endpoint assessment using photography. The trial will have a maximum of three planned analyses with unequally spaced reviews at event-driven coherent cut-points. The futility boundaries are constructed as non-binding to allow a decision for stopping early to be overruled by the Data Monitoring and Ethics Committee. The double triangular, group sequential design of the PRESSURE 2 trial will provide an efficient design through the possibility of early stopping for

Clinical Trials

Medline Plus

Full Text Available ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

Clinical Efficacy of Jump Training Augmented With Body Weight Support After ACL Reconstruction: A Randomized Controlled Trial.

Science.gov (United States)

Elias, Audrey R C; Harris, Kari J; LaStayo, Paul C; Mizner, Ryan L

2018-06-01

Limited knee flexion and increased muscle co-contraction during jump landing are believed to diminish outcomes after anterior cruciate ligament (ACL) reconstruction. The efficacy of jump training to improve patients' mechanical and neuromuscular deficits is understudied. Jump training will improve functional, mechanical, and neuromuscular outcomes and higher repetition training augmented by body weight support will result in better retention of gains. Randomized controlled trial; Level of evidence, 1. Thirty athletes (18 months after surgery) were screened, and 19 with mechanical deficits and limited clinical outcomes were enrolled in the trial. Testing included the International Knee Documentation Committee (IKDC) questionnaire, leg landing mechanics via motion analysis, knee joint effusion using a stroke test, and a surface electromyography-generated co-contraction index during a single-legged landing. Participants were randomly assigned to 1 of 2 groups: jump training with normal body weight (JTBW) and high-repetition jump training with body weight support (JTBWS). Knee effusion grading throughout training was used to assess joint tolerance. Changes in outcomes over time were analyzed with mixed-effects modeling. Immediate outcomes were compared with retention testing at 8 weeks after training by use of 2-way analyses of variance with effects of time and group. Significant effects of time were found during the training phase for all outcome measures, but no effects of group or sex were found. IKDC score (pooled; mean ± SD) increased from 76 ± 12 to 87 ± 8 ( P Jump training mitigated some risk factors for second injury and osteoarthritis in patients after ACL reconstruction. Training made lasting improvements in physical function measures as well as mechanical and neuromuscular coordination deficits. Higher repetitions used with body weight support did not improve retention but substantially reduced risk for effusion. Jump training is an efficacious

Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS: a randomised controlled trial

Directory of Open Access Journals (Sweden)

Kenyon Sara

2012-02-01

Full Text Available Abstract Background Maternal, neonatal and child health outcomes are worse in families from black and ethnic minority groups and disadvantaged backgrounds. There is little evidence on whether lay support improves maternal and infant outcomes among women with complex social needs within a disadvantaged multi-ethnic population in the United Kingdom (UK. Method/Design The aim of this study is to evaluate a lay Pregnancy Outreach Worker (POW service for nulliparous women identified as having social risk within a maternity service that is systematically assessing social risks alongside the usual obstetric and medical risks. The study design is a randomised controlled trial (RCT in nulliparous women assessed as having social risk comparing standard maternity care with the addition of referral to the POW support service. The POWs work alongside community midwifery teams and offer individualised support to women to encourage engagement with services (health and social care from randomisation (before 28 weeks gestation until 6 weeks after birth. The primary outcomes have been chosen on the basis that they are linked to maternal and infant health. The two primary outcomes are engagement with antenatal care, assessed by the number of antenatal visits; and maternal depression, assessed using the Edinburgh Postnatal Depression Scale at 8-12 weeks after birth. Secondary outcomes include maternal and neonatal morbidity and mortality, routine child health assessments, including immunisation uptake and breastfeeding at 6 weeks. Other psychological outcomes (self efficacy and mother-to-infant bonding will also be collected using validated tools. A sample size of 1316 will provide 90% power (at the 5% significance level to detect increased engagement with antenatal services of 1.5 visits and a reduction of 1.5 in the average EPDS score for women with two or more social risk factors, with power in excess of this for women with any social risk factor. Analysis will

Pregnancy Exercise and Nutrition With Smartphone Application Support: A Randomized Controlled Trial.

Science.gov (United States)

Kennelly, Maria A; Ainscough, Kate; Lindsay, Karen L; OʼSullivan, Elizabeth; Gibney, Eileen R; McCarthy, Mary; Segurado, Ricardo; DeVito, Giuseppe; Maguire, Orla; Smith, Thomas; Hatunic, Mensud; McAuliffe, Fionnuala M

2018-05-01

To evaluate the effect of a healthy lifestyle package (an antenatal behavior change intervention supported by smartphone application technology) on the incidence of gestational diabetes mellitus (GDM) in overweight and obese women. Women with body mass indexes (BMIs) 25-39.9 were enrolled into this randomized controlled trial. The intervention consisted of specific dietary and exercise advice that addressed behavior change supported by a tailor-designed smartphone application. Women in the control group received usual care. The primary outcome was the incidence of GDM at 28-30 weeks of gestation. To reduce GDM from 15% to 7.2%, we estimated that 506 women would be required to have 80% power to detect this effect size at a significance of .05, that is, 253 in each group. Between March 2013 and February 2016, 565 women were recruited with a mean BMI of 29.3 and mean gestational age of 15.5 weeks. The incidence of GDM did not differ between the two groups, 37 of 241 (15.4%) in the intervention group compared with 36 of 257 (14.1%) in the control group (relative risk 1.1, 95% CI 0.71-1.66, P=.71). A mobile health-supported behavioral intervention did not decrease the incidence of GDM. ISRCTN registry, https://www.isrctn.com/, ISRCTN29316280.

Teaching school children basic life support improves teaching and basic life support skills of medical students: A randomised, controlled trial.

Science.gov (United States)

Beck, Stefanie; Meier-Klages, Vivian; Michaelis, Maria; Sehner, Susanne; Harendza, Sigrid; Zöllner, Christian; Kubitz, Jens Christian

2016-11-01

The "kids save lives" joint-statement highlights the effectiveness of training all school children worldwide in cardiopulmonary resuscitation (CPR) to improve survival after cardiac arrest. The personnel requirement to implement this statement is high. Until now, no randomised controlled trial investigated if medical students benefit from their engagement in the BLS-education of school children regarding their later roles as physicians. The objective of the present study is to evaluate if medical students improve their teaching behaviour and CPR-skills by teaching school children in basic life support. The study is a randomised, single blind, controlled trial carried out with medical students during their final year. In total, 80 participants were allocated alternately to either the intervention or the control group. The intervention group participated in a CPR-instructor-course consisting of a 4h-preparatory seminar and a teaching-session in BLS for school children. The primary endpoints were effectiveness of teaching in an objective teaching examination and pass-rates in a simulated BLS-scenario. The 28 students who completed the CPR-instructor-course had significantly higher scores for effective teaching in five of eight dimensions and passed the BLS-assessment significantly more often than the 25 students of the control group (Odds Ratio (OR): 10.0; 95%-CI: 1.9-54.0; p=0.007). Active teaching of BLS improves teaching behaviour and resuscitation skills of students. Teaching school children in BLS may prepare medical students for their future role as a clinical teacher and support the implementation of the "kids save lives" statement on training all school children worldwide in BLS at the same time. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Comparison of body weight-supported treadmill training versus body weight-supported overground training in people with incomplete tetraplegia: a pilot randomized trial.

Science.gov (United States)

Senthilvelkumar, Thangavelu; Magimairaj, Henry; Fletcher, Jebaraj; Tharion, George; George, Jacob

2015-01-01

To compare the effectiveness of body weight-supported treadmill training and body weight-supported overground training for improving gait and strength in people with traumatic incomplete tetraplegia. Assessor blinded randomized trial. Rehabilitation institute of a tertiary care teaching hospital in India. Sixteen participants with traumatic motor incomplete tetraplegia and within two years of injury. Participants were randomised to one of two groups: body weight-supported overground training on level ground and body weight-supported treadmill training. Both groups received 30 minutes of gait training per day, five days a week for eight weeks. In addition, both groups received regular rehabilitation which included flexibility, strength, balance, self care and functional training. The primary outcome measure was the Walking Index for Spinal Cord Injury (/20 points) and the secondary outcome was the Lower Extremity Muscle Score (/50 points). There was no statistically significant between group differences in the Walking Index for Spinal Cord Injury [mean difference=0.3points; 95% CI (-4.8 to 5.4); p=0.748] or the Lower Extremity Muscle Score [mean difference=0.2 points; 95% CI (-3.8 to 5.1); p=0.749]. Gait training with body weight-supported overground training is comparable to treadmill training for improving locomotion in people with traumatic incomplete tetraplegia. © The Author(s) 2014.

Recruitment to publicly funded trials--are surgical trials really different?

Science.gov (United States)

Cook, Jonathan A; Ramsay, Craig R; Norrie, John

2008-09-01

Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n=114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n=18, median=38.0 IQR (10.7, 77.4)) versus (n=81, median=34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (-19.2, 25.1); p=0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n=6, 68.3 (23.5, 294.8)) versus (n=93, 34.6 (11.7, 90.0); median difference 25.9 (-35.5, 221.8); p=0.291) for the other trials. There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.

Clinical Trials

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... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... by participating in a clinical trial is to science first and to the patient second. More About ...

A multisite randomized controlled trial on time to self-support among sickness absence beneficiaries

DEFF Research Database (Denmark)

Nielsen, Maj Britt D.; Vinsløv Hansen, Jørgen; Aust, Birgit

2015-01-01

BACKGROUND: In 2010, the Danish Government launched the Danish national return-to-work (RTW) programme to reduce sickness absence and promote labour market attainment. Multidisciplinary teams delivered the RTW programme, which comprised a coordinated, tailored and multidisciplinary effort (CTM......) for sickness absence beneficiaries at high risk for exclusion from the labour market. The aim of this article was to evaluate the effectiveness of the RTW programme on self-support. METHODS: Beneficiaries from three municipalities (denoted M1, M2 and M3) participated in a randomized controlled trial. We.......54-0.95). In M1, we found no difference between the two groups (HR = 0.99, 95% CI: 0.84-1.17). CONCLUSION: The effect of the CTM programme on return to self-support differed substantially across the three participating municipalities. Thus, generalizing the study results to other Danish municipalities...

Framing the role of Decision Support in the case of Stockholm Congestion Charging Trial

DEFF Research Database (Denmark)

Gudmundsson, Henrik; Ericsson, Eva; Hugosson, Muriel Besser

2009-01-01

the way for investigating the use and role of ‘Decision Support’ in the Stockholm Congestion Charging experiment. We adopt a definition of Decision Support as the systematic application of externally produced knowledge in transport planning and policy making processes. We then derive an analytical...... framework from the research literature on ‘knowledge utilization’ in policy making. This research has generally found that both ‘technical’, ‘communicative’, and ‘institutional’ aspects of the Decision Support matter for its influence on actual policy making processes and results. In our analysis we find...... in a Swedish context, and the introduction of the Stockholm system has been highly controversial. Considerable efforts have therefore been undertaken to provide information that could serve as ‘Decision Support’ along the way. This has included e.g. modelling and forecasts before the Trial, a comprehensive...

The Effect of Social Support Features and Gamification on a Web-Based Intervention for Rheumatoid Arthritis Patients: Randomized Controlled Trial

Science.gov (United States)

Kostova, Zlatina; Nakamoto, Kent; Schulz, Peter Johannes

2015-01-01

Background Rheumatoid arthritis (RA) is chronic systematic disease that affects people during the most productive period of their lives. Web-based health interventions have been effective in many studies; however, there is little evidence and few studies showing the effectiveness of online social support and especially gamification on patients’ behavioral and health outcomes. Objective The aim of this study was to look into the effects of a Web-based intervention that included online social support features and gamification on physical activity, health care utilization, medication overuse, empowerment, and RA knowledge of RA patients. The effect of gamification on website use was also investigated. Methods We conducted a 5-arm parallel randomized controlled trial for RA patients in Ticino (Italian-speaking part of Switzerland). A total of 157 patients were recruited through brochures left with physicians and were randomly allocated to 1 of 4 experimental conditions with different types of access to online social support and gamification features and a control group that had no access to the website. Data were collected at 3 time points through questionnaires at baseline, posttest 2 months later, and at follow-up after another 2 months. Primary outcomes were physical activity, health care utilization, and medication overuse; secondary outcomes included empowerment and RA knowledge. All outcomes were self-reported. Intention-to-treat analysis was followed and multilevel linear mixed models were used to study the change of outcomes over time. Results The best-fit multilevel models (growth curve models) that described the change in the primary outcomes over the course of the intervention included time and empowerment as time-variant predictors. The growth curve analyses of experimental conditions were compared to the control group. Physical activity increased over time for patients having access to social support sections plus gaming (unstandardized beta coefficient

Visualization of pulmonary vein stenosis after radio frequency ablation for treatment of atrial fibrillation using multidetector computed tomography with retrospective gating; Darstellung von Pulmonalvenenstenosen nach Radiofrequenzablation zur Behandlung von Vorhofflimmern unter Verwendung der Multidetektor Computertomographie mit retrospektivem Gating

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Trabold, T.; Kuettner, A.; Heuschmid, M.; Kopp, A.F.; Claussen, C.D. [Radiologische Klinik, Abt. fuer Radiologische Diagnostik, Univ. Tuebingen (Germany); Burgstahler, C.; Mewis, C.; Schroeder, S.; Kuehlkamp, V. [Medizinische Klinik III, Abt. fuer Kardiologie, Univ. Tuebingen (Germany)

2003-01-01

Purpose: With the number of radio frequency ablations (RFA) for treatment of chronic atrial fibrillation increasing, the diagnostic evaluation for RFA associated pulmonary vein stenosis is getting more important. This study investigates the feasibility of the visualization of pulmonary vein stenosis using non-invasive multidetector computed tomography. Materials and Methods: Twenty-eight patients were examined following RFA-treatment. A 4-slice (20 patients) and a 16-slice (8 patients) multidetector CT scanner (SOMATOM Volume Zoom and Sensation 16, Siemens, Forchheim, Germany) with retrospective gating was used to assess the pulmonary veins. Lesion severity was determined on a semi-quantitative scale (< 30%, 30 - 50%, > 50%). Results: CT was performed without any complications in all patients. Diagnostic image quality could be obtained in all examinations. The pulmonary veins showed lesions < 30% in four patients, lesions of 30 - 50% in five patients and a stenosis > 50% in one patient. Eighteen patients showed no lesions. Conclusion: Multidetector CT of the pulmonary veins seems to be able to visualize high-grade and low-grade lesions, but larger catheter-controlled studies are needed for further assessment of the diagnostic accuracy and clinical reliability of this noninvasive method. (orig.) [German] Ziel: Mit steigender Anzahl von Radiofrequenzablationen (RFA) zur Behandlung des chronischen Vorhofflimmerns wird die Diagnostik von RFA assoziierten Pulmonalvenenstenosen zunehmend wichtiger. Ziel dieser Studie war es, die Moeglichkeit der Darstellung von Pulmonalvenenstenosen mittels der nichtinvasiven Multidetektor-Computertomographie zu untersuchen. Material und Methoden: 28 Patienten wurden im Anschluss an eine RFA-Behandlung untersucht. Die Untersuchung wurde an einem 4-Zeilen- (20 Patienten) bzw. 16-Zeilen- (8 Patienten) Multidetektor-CT (SOMATOM Volume Zoom bzw. Sensation 16, Siemens, Forchheim, Germany) mit retrospektivem Gating durchgefuehrt. Der

Continuous support for women during childbirth.

Science.gov (United States)

Bohren, Meghan A; Hofmeyr, G Justus; Sakala, Carol; Fukuzawa, Rieko K; Cuthbert, Anna

2017-07-06

Historically, women have generally been attended and supported by other women during labour. However, in hospitals worldwide, continuous support during labour has often become the exception rather than the routine. The primary objective was to assess the effects, on women and their babies, of continuous, one-to-one intrapartum support compared with usual care, in any setting. Secondary objectives were to determine whether the effects of continuous support are influenced by:1. Routine practices and policies in the birth environment that may affect a woman's autonomy, freedom of movement and ability to cope with labour, including: policies about the presence of support people of the woman's own choosing; epidural analgesia; and continuous electronic fetal monitoring.2. The provider's relationship to the woman and to the facility: staff member of the facility (and thus has additional loyalties or responsibilities); not a staff member and not part of the woman's social network (present solely for the purpose of providing continuous support, e.g. a doula); or a person chosen by the woman from family members and friends;3. Timing of onset (early or later in labour);4. Model of support (support provided only around the time of childbirth or extended to include support during the antenatal and postpartum periods);5. Country income level (high-income compared to low- and middle-income). We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2016), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 June 2017) and reference lists of retrieved studies. All published and unpublished randomised controlled trials, cluster-randomised trials comparing continuous support during labour with usual care. Quasi-randomised and cross-over designs were not eligible for inclusion. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We sought

Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial

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Wenborn Jennifer

2011-09-01

Full Text Available Abstract Background Peer support interventions can improve carer wellbeing and interventions that engage both the carer and person with dementia can have significant mutual benefits. Existing research has been criticised for inadequate rigour of design or reporting. This paper describes the protocol for a complex trial that evaluates one-to-one peer support and a group reminiscence programme, both separately and together, in a factorial design. Design A 2 × 2 factorial multi-site randomised controlled trial of individual peer support and group reminiscence interventions for family carers and people with dementia in community settings in England, addressing both effectiveness and cost-effectiveness. Discussion The methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches. Trial Registration ISRCTN37956201

Comparison of electronic health record system functionalities to support the patient recruitment process in clinical trials.

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Schreiweis, Björn; Trinczek, Benjamin; Köpcke, Felix; Leusch, Thomas; Majeed, Raphael W; Wenk, Joachim; Bergh, Björn; Ohmann, Christian; Röhrig, Rainer; Dugas, Martin; Prokosch, Hans-Ulrich

2014-11-01

Reusing data from electronic health records for clinical and translational research and especially for patient recruitment has been tackled in a broader manner since about a decade. Most projects found in the literature however focus on standalone systems and proprietary implementations at one particular institution often for only one singular trial and no generic evaluation of EHR systems for their applicability to support the patient recruitment process does yet exist. Thus we sought to assess whether the current generation of EHR systems in Germany provides modules/tools, which can readily be applied for IT-supported patient recruitment scenarios. We first analysed the EHR portfolio implemented at German University Hospitals and then selected 5 sites with five different EHR implementations covering all major commercial systems applied in German University Hospitals. Further, major functionalities required for patient recruitment support have been defined and the five sample EHRs and their standard tools have been compared to the major functionalities. In our analysis of the site's hospital information system environments (with four commercial EHR systems and one self-developed system) we found that - even though no dedicated module for patient recruitment has been provided - most EHR products comprise generic tools such as workflow engines, querying capabilities, report generators and direct SQL-based database access which can be applied as query modules, screening lists and notification components for patient recruitment support. A major limitation of all current EHR products however is that they provide no dedicated data structures and functionalities for implementing and maintaining a local trial registry. At the five sites with standard EHR tools the typical functionalities of the patient recruitment process could be mostly implemented. However, no EHR component is yet directly dedicated to support research requirements such as patient recruitment. We

Preventative tele-health supported services for early stage chronic obstructive pulmonary disease: a protocol for a pragmatic randomized controlled trial pilot

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Mountain Gail A

2011-01-01

Full Text Available Abstract Background Chronic Obstructive Pulmonary Disease (COPD is a prevalent debilitating long term condition. It is the second most common cause of emergency admission to hospital in the UK and remains one of the most costly conditions to treat through acute care. Tele-health monitoring offers potential to reduce the rates of re-hospitalisation and emergency department visits and improve quality of life for people with COPD. However, the current evidence base to support technology adoption and implementation is limited and the resource implications for implementing tele-health in practice can be very high. This trial will employ tele-health monitoring in a preventative capacity for patients diagnosed with early stage COPD following discharge from hospital to determine whether it reduces their need for additional health service support or hospital admission and improves their quality of life. Methods/Design We describe a pilot study for a two arm, one site randomized controlled trial (RCT to determine the effect of tele-health monitoring on self-management, quality of life and patient satisfaction. Sixty patients who have been discharged from one acute trust with a primary diagnosis of COPD and who have agreed to receive community clinical support following discharge from acute care will be randomly assigned to one of two groups: (a Tele-health supported Community COPD Service; or (b Usual Care. The tele-health supported service involves the patient receiving two home visits with a specialist COPD clinician (nurse or physiotherapist then participating in daily tele-monitoring over an eight week period. Usual care consists of six home visits to the patient by specialist COPD clinicians again over eight successive weeks. Health status and quality of life data for all participants will be measured at baseline, on discharge from the service and at six months post discharge from the service. Discussion The tele-health service under study is a

A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial.

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Nabulsi, Mona; Hamadeh, Haya; Tamim, Hani; Kabakian, Tamar; Charafeddine, Lama; Yehya, Nadine; Sinno, Durriyah; Sidani, Saadieh

2014-01-15

Breastfeeding has countless benefits to mothers, children and community at large, especially in developing countries. Studies from Lebanon report disappointingly low breastfeeding exclusivity and continuation rates. Evidence reveals that antenatal breastfeeding education, professional lactation support, and peer lay support are individually effective at increasing breastfeeding duration and exclusivity, particularly in low-income settings. Given the complex nature of the breastfeeding ecosystem and its barriers in Lebanon, we hypothesize that a complex breastfeeding support intervention, which is centered on the three components mentioned above, would significantly increase breastfeeding rates. A multi-center randomized controlled trial. 443 healthy pregnant women in their first trimester will be randomized to control or intervention group. A "prenatal/postnatal" professional and peer breastfeeding support package continuing till 6 months postpartum, guided by the Social Network and Social Support Theory. Control group will receive standard prenatal and postnatal care. Mothers will be followed up from early pregnancy till five years after delivery. Total and exclusive breastfeeding rates, quality of life at 1, 3 and 6 months postpartum, maternal breastfeeding knowledge and attitudes at 6 months postpartum, maternal exclusive breastfeeding rates of future infants up to five years from baseline, cost-benefit and cost-effectiveness analyses of the intervention. Descriptive and regression analysis will be conducted under the intention to treat basis using the most recent version of SPSS. Exclusive breastfeeding is a cost-effective public health measure that has a significant impact on infant morbidity and mortality. In a country with limited healthcare resources like Lebanon, developing an effective breastfeeding promotion and support intervention that is easily replicated across various settings becomes a priority. If positive, the results of this study would provide

School-based intervention for childhood disruptive behavior in disadvantaged settings: A randomized controlled trial with and without active teacher support

NARCIS (Netherlands)

Liber, J.M.; de Boo, G.M.; Huizenga, H.; Prins, P.J.M.

2013-01-01

Objective: In this randomized controlled trial, we investigated the effectiveness of a school-based targeted intervention program for disruptive behavior. A child-focused cognitive behavioral therapy (CBT) program was introduced at schools in disadvantaged settings and with active teacher support

Research Areas - Clinical Trials

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Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

Developing a Framework of Innovative Trials to Support Water Companies Strategic Response to WFD

Science.gov (United States)

Whitehead, Jodie; Cherry, Katherine; Revens, Neasa; O'Hanlon, Thomas

2014-05-01

Slug control in high risk fields and catchments can have serious implications for water companies, threatening compliance with drinking water standards and challenging the Water Framework Directive's requirement that additional water treatment is avoided. Severn Trent Water has established a framework of innovative trails at a range of scales and locations to help shape the company's strategic, sustainable response to elevated metaldehyde concentrations at drinking water abstractions. Currently four contrasting trials are underway, two at the catchment scale, one at the field scale and one at the 'operational site' scale at locations across the English Midlands. This presentation provides an overview of the different approaches, their effectiveness to date and lessons learnt to aid strategy development. The first trial entitled Farmer's as Producers of Clean Water adopts a 'results orientated' approach, rewarding farmers for improvements in water quality at the catchment scale and allowing farmers to decide how best to manage the issue on their land with no prescribed measures. It acknowledges that co-ordinated action is needed across the catchment to see improvements in water quality, and that by incentivising outcomes rather than actions, land owners and farmers may take greater ownership of water quality issues. The second project explores the potential for a 'zero metaldehyde' catchment with all farmers throughout the catchment being financial supported to use a water friendly alternative to metaldehyde. This project is being compared to more voluntary approaches adopted elsewhere. The third project is a field scale trial to test the efficacy of alternative products to metaldehyde and different pellet formulations. Field drains are being sampled following heavy rain and crop damaged assessed to review the benefits to water quality and crops. The final project considers what Severn Trent Water can do from an operational perspective, investigating the size and

A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial

Directory of Open Access Journals (Sweden)

Pellegrini Christine A

2012-11-01

Full Text Available Abstract Background Obesity remains a major public health challenge, demanding cost-effective and scalable weight management programs. Delivering key treatment components via mobile technology offers a potential way to reduce expensive in-person contact, thereby lowering the cost and burden of intensive weight loss programs. The ENGAGED study is a theory-guided, randomized controlled trial designed to examine the feasibility and efficacy of an abbreviated smartphone-supported weight loss program. Methods/design Ninety-six obese adults (BMI 30–39.9 kg/m2 will be randomized to one of three treatment conditions: (1 standard behavioral weight loss (STND, (2 technology-supported behavioral weight loss (TECH; or (3 self-guided behavioral weight loss (SELF. All groups will aim to achieve a 7% weight loss goal by reducing calorie and fat intake and progressively increasing moderate intensity physical activity to 175 minutes/week. STND and TECH will attend 8 group sessions and receive regular coaching calls during the first 6 months of the intervention; SELF will receive the Group Lifestyle Balance Program DVD’s and will not receive coaching calls. During months 1–6, TECH will use a specially designed smartphone application to monitor dietary intake, body weight, and objectively measured physical activity (obtained from a Blue-tooth enabled accelerometer. STND and SELF will self-monitor on paper diaries. Linear mixed modeling will be used to examine group differences on weight loss at months 3, 6, and 12. Self-monitoring adherence and diet and activity goal attainment will be tested as mediators. Discussion ENGAGED is an innovative weight loss intervention that integrates theory with emerging mobile technologies. We hypothesize that TECH, as compared to STND and SELF, will result in greater weight loss by virtue of improved behavioral adherence and goal achievement. Trial registration NCT01051713

Testing a self-determination theory intervention for motivating tobacco cessation: supporting autonomy and competence in a clinical trial.

Science.gov (United States)

Williams, Geoffrey C; McGregor, Holly A; Sharp, Daryl; Levesque, Chantal; Kouides, Ruth W; Ryan, Richard M; Deci, Edward L

2006-01-01

A longitudinal randomized trial tested the self-determination theory (SDT) intervention and process model of health behavior change for tobacco cessation (N = 1006). Adult smokers were recruited for a study of smokers' health and were assigned to intensive treatment or community care. Participants were relatively poor and undereducated. Intervention patients perceived greater autonomy support and reported greater autonomous and competence motivations than did control patients. They also reported greater medication use and significantly greater abstinence. Structural equation modeling analyses confirmed the SDT process model in which perceived autonomy support led to increases in autonomous and competence motivations, which in turn led to greater cessation. The causal role of autonomy support in the internalization of autonomous motivation, perceived competence, and smoking cessation was supported. Copyright 2006 APA, all rights reserved.

Radiological findings, evaluation and treatment of patellofemoral pain after total knee arthroplasty; Radiologische Diagnostik, Beurteilung und Behandlung des patellofemoralen Schmerzes nach primaerer Knieendoprothetik

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Springorum, H.R.; Keshmiri, A.; Heers, G.; Renkawitz, T.; Grifka, J.; Baier, C. [Asklepios Klinikum Bad Abbach, Orthopaedische Klinik fuer die Universitaet Regensburg, Bad Abbach (Germany)

2012-11-15

Total knee arthroplasty (TKA) is one of the most successful operative procedures over the last decades in orthopedic surgery; however, some patients suffer from pain, limited range of motion, instability, infections or other complications postoperatively. Patellofemoral pain (PFP) in particular is a common problem after TKA and often necessitates revision surgery. Mainly increasing and localized contact pressure and patella maltracking are held responsible for PFP but the reasons vary. Diagnostics and therapy of PFP is not easy to manage and should be treated following a clinical pathway. The authors suggest that patients with PFP should be categorized after basic diagnostic measures according to the suspected diagnosis: (1) tendinosis, (2) mechanical reasons, (3) intra-articular non-mechanical reasons and (4) neurogenic/psychiatric reasons. Efficient application of special diagnostic measures and further therapy is facilitated by this classification. (orig.) [German] Die endoprothetische Versorgung des Kniegelenks ist eine Operation mit hohem Zugewinn an Lebensqualitaet. Dennoch sind je nach Literaturstelle bis zu 50% der Patienten von Schmerzen, Bewegungseinschraenkung, Instabilitaet, Infektion oder anderen Komplikationen betroffen. Insbesondere der patellofemorale Schmerz (PFS) ist eine haeufige Komplikation nach primaerer Knieendoprothetik und wird je nach Literatur mit 1-50% der Faelle angegeben. Insbesondere der erhoehte retropatellare Anpressdruck und eine schlechte Fuehrung der Patella werden fuer den PFS verantwortlich gemacht, doch die Ursachen sind vielfaeltig. Diagnostik und Behandlung sind komplex und sollten strukturiert durchgefuehrt werden. Nach der Basisdiagnostik schlagen die Autoren daher eine Einteilung in eine der 4 Gruppen vor: (1) Tendinosen, (2) mechanische Probleme, (3) intraartikulaere nichtmechanische Probleme, (4) neurogene/psychische Probleme. Durch die Einteilung in diese verschiedenen Gruppen werden eine effiziente spezielle

Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial.

Science.gov (United States)

Harvey, Allison G; Dong, Lu; Lee, Jason Y; Gumport, Nicole B; Hollon, Steven D; Rabe-Hesketh, Sophia; Hein, Kerrie; Haman, Kirsten; McNamara, Mary E; Weaver, Claire; Martinez, Armando; Notsu, Haruka; Zieve, Garret; Armstrong, Courtney C

2017-11-14

The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT). Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings. ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.

Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial

Directory of Open Access Journals (Sweden)

van Gaalen Johanna L

2012-11-01

Full Text Available Abstract Background Internet-based self-management (IBSM support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. Methods/design This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS: dissemination of the IBSM program; intermediate strategy (IS: MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals; and extended strategy (ES: IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions are primarily targeted at general practices, randomisation will occur at practice level. In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations; self-management related outcomes (health education impact, medication adherence, and illness perceptions; and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption

Radioiodine therapy in veterinary medicine: treatment of hyperthyroidism in a cat; Die Radioiodtherapie in der Veterinaermedizin: Behandlung der Schilddruesenueberfunktion bei einer Katze

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Reinartz, P.; Sabri, O.; Zimny, M.; Buell, U. [Technische Hochschule Aachen (Germany). Klinik fuer Nuklearmedizin; Kinzel, S.; Kuepper, W. [Technische Hochschule Aachen (Germany). Inst. fuer Versuchstierkunde; Bachmann, T. [Tierarztpraxis Dr. med. vet. Thomas Bachmann, Glashhuetten (Germany)

1999-06-01

die Katze ohne schilddruesenspezifische Medikation eine euthyreote Stoffwechsellage auf. Der vorliegenden Fall zeigt, dass die Radioiodtherapie als komplikationsarme und effiziente Methode zur Behandlung von Schilddruesenueberfunktionen bei Kleintieren in der Veterinaermedizin geeignet ist. (orig.)

Single-Trial Classification of Bistable Perception by Integrating Empirical Mode Decomposition, Clustering, and Support Vector Machine

Directory of Open Access Journals (Sweden)

Hualou Liang

2008-04-01

Full Text Available We propose an empirical mode decomposition (EMD- based method to extract features from the multichannel recordings of local field potential (LFP, collected from the middle temporal (MT visual cortex in a macaque monkey, for decoding its bistable structure-from-motion (SFM perception. The feature extraction approach consists of three stages. First, we employ EMD to decompose nonstationary single-trial time series into narrowband components called intrinsic mode functions (IMFs with time scales dependent on the data. Second, we adopt unsupervised K-means clustering to group the IMFs and residues into several clusters across all trials and channels. Third, we use the supervised common spatial patterns (CSP approach to design spatial filters for the clustered spatiotemporal signals. We exploit the support vector machine (SVM classifier on the extracted features to decode the reported perception on a single-trial basis. We demonstrate that the CSP feature of the cluster in the gamma frequency band outperforms the features in other frequency bands and leads to the best decoding performance. We also show that the EMD-based feature extraction can be useful for evoked potential estimation. Our proposed feature extraction approach may have potential for many applications involving nonstationary multivariable time series such as brain-computer interfaces (BCI.

A multicentre, randomised controlled, non-inferiority trial, comparing nasal high flow with nasal continuous positive airway pressure as primary support for newborn infants with early respiratory distress born in Australian non-tertiary special care nurseries (the HUNTER trial): study protocol.

Science.gov (United States)

Manley, Brett J; Roberts, Calum T; Arnolda, Gaston R B; Wright, Ian M R; Owen, Louise S; Dalziel, Kim M; Foster, Jann P; Davis, Peter G; Buckmaster, Adam G

2017-06-23

Nasal high-flow (nHF) therapy is a popular mode of respiratory support for newborn infants. Evidence for nHF use is predominantly from neonatal intensive care units (NICUs). There are no randomised trials of nHF use in non-tertiary special care nurseries (SCNs). We hypothesise that nHF is non-inferior to nasal continuous positive airway pressure (CPAP) as primary support for newborn infants with respiratory distress, in the population cared for in non-tertiary SCNs. The HUNTER trial is an unblinded Australian multicentre, randomised, non-inferiority trial. Infants are eligible if born at a gestational age ≥31 weeks with birth weight ≥1200 g and admitted to a participating non-tertiary SCN, are 1 hour. Infants are randomised to treatment with either nHF or CPAP. The primary outcome is treatment failure within 72 hours of randomisation, as determined by objective oxygenation, apnoea or blood gas criteria or by a clinical decision that urgent intubation and mechanical ventilation, or transfer to a tertiary NICU, is required. Secondary outcomes include incidence of pneumothorax requiring drainage, duration of respiratory support, supplemental oxygen and hospitalisation, costs associated with hospital care, cost-effectiveness, parental stress and satisfaction and nursing workload. Multisite ethical approval for the study has been granted by The Royal Children's Hospital, Melbourne, Australia (Trial Reference No. 34222), and by each participating site. The trial is currently recruiting in eight centres in Victoria and New South Wales, Australia, with one previous site no longer recruiting. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences. Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001203640; pre-results. © 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

Sustainable development of a GCP-compliant clinical trials platform in Africa: the malaria clinical trials alliance perspective.

Science.gov (United States)

Ogutu, Bernhards R; Baiden, Rita; Diallo, Diadier; Smith, Peter G; Binka, Fred N

2010-04-20

The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres. Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials. In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The MCTA experience also indicates that

Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial.

Science.gov (United States)

Christensen, Thomas Nordahl; Nielsen, Iben Gammelgaard; Stenager, Elsebeth; Morthorst, Britt Reuter; Lindschou, Jane; Nordentoft, Merete; Eplov, Lene Falgaard

2015-06-21

Individual Placement and Support (IPS) appears to be an effective vocational intervention for obtaining competitive employment for people with severe mental illness. However, no IPS studies or trials have been conducted in Denmark, a country characterized by a specialized labor market with a higher minimum wage and fewer entry-level jobs in comparison with other countries such as the US. Furthermore, long-term job retention and economic self-sufficiency have not been clearly demonstrated. Integrating methods such as cognitive remediation and work-related social skills training may be ways to address these issues. The trial design is an investigator-initiated, randomized, assessor-blinded, multi-center trial. A total of 750 patients with severe mental illness will be randomly assigned into three groups: (1) IPS, (2) IPS enhanced with cognitive remediation and work-related social skills training, and (3) service as usual. The primary outcome is number of hours in competitive employment or education at 18-month follow-up. Secondary and exploratory outcomes are money earned, days to first employment, symptoms, functional level, self-esteem, and self-efficacy at 18-month follow-up. Thirty- and 60-month follow-ups will be register-based. This will be one of the largest randomized trials investigating IPS to date. The trial will be conducted with high methodological quality in order to reduce the risk of bias. If the results of this trial show that IPS, or IPS enhanced with cognitive remediation and work-related social skills training, is superior to service as usual, this will support preliminary evidence. Furthermore, it will show that the method is generalizable to a variety of labor markets and welfare systems and provide important knowledge about the effect of adding cognitive remediation and social skills training to the IPS intervention. ClinicalTrials registration number: NCT01722344 (registered 2 Nov. 2012).

Supportive supervision for volunteers to deliver reproductive health education: a cluster randomized trial.

Science.gov (United States)

Singh, Debra; Negin, Joel; Orach, Christopher Garimoi; Cumming, Robert

2016-10-03

Community Health Volunteers (CHVs) can be effective in improving pregnancy and newborn outcomes through community education. Inadequate supervision of CHVs, whether due to poor planning, irregular visits, or ineffective supervisory methods, is, however, recognized as a weakness in many programs. There has been little research on best practice supervisory or accompaniment models. From March 2014 to February 2015 a proof of concept study was conducted to compare training alone versus training and supportive supervision by paid CHWs (n = 4) on the effectiveness of CHVs (n = 82) to deliver education about pregnancy, newborn care, family planning and hygiene. The pair-matched cluster randomized trial was conducted in eight villages (four intervention and four control) in Budondo sub-county in Jinja, Uganda. Increases in desired behaviors were seen in both the intervention and control arms over the study period. Both arms showed high retention rates of CHVs (95 %). At 1 year follow-up there was a significantly higher prevalence of installed and functioning tippy taps for hand washing (p services. Supportive supervision involves creating a non-threatening, empowering environment in which both the CHV and the supervising CHW learn together and overcome obstacles that might otherwise demotivate the CHV. While the results seem promising for added value with supportive supervision for CHVs undertaking reproductive health activities, further research on a larger scale will be needed to substantiate the effect.

Nutrition support in hospitalised adults at nutritional risk.

Science.gov (United States)

Feinberg, Joshua; Nielsen, Emil Eik; Korang, Steven Kwasi; Halberg Engell, Kirstine; Nielsen, Marie Skøtt; Zhang, Kang; Didriksen, Maria; Lund, Lisbeth; Lindahl, Niklas; Hallum, Sara; Liang, Ning; Xiong, Wenjing; Yang, Xuemei; Brunsgaard, Pernille; Garioud, Alexandre; Safi, Sanam; Lindschou, Jane; Kondrup, Jens; Gluud, Christian; Jakobsen, Janus C

2017-05-19

The prevalence of disease-related malnutrition in Western European hospitals is estimated to be about 30%. There is no consensus whether poor nutritional status causes poorer clinical outcome or if it is merely associated with it. The intention with all forms of nutrition support is to increase uptake of essential nutrients and improve clinical outcome. Previous reviews have shown conflicting results with regard to the effects of nutrition support. To assess the benefits and harms of nutrition support versus no intervention, treatment as usual, or placebo in hospitalised adults at nutritional risk. We searched Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE (Ovid SP), Embase (Ovid SP), LILACS (BIREME), and Science Citation Index Expanded (Web of Science). We also searched the World Health Organization International Clinical Trials Registry Platform (www.who.int/ictrp); ClinicalTrials.gov; Turning Research Into Practice (TRIP); Google Scholar; and BIOSIS, as well as relevant bibliographies of review articles and personal files. All searches are current to February 2016. We include randomised clinical trials, irrespective of publication type, publication date, and language, comparing nutrition support versus control in hospitalised adults at nutritional risk. We exclude trials assessing non-standard nutrition support. We used standard methodological procedures expected by Cochrane and the Cochrane Hepato-Biliary Group. We used trial domains to assess the risks of systematic error (bias). We conducted Trial Sequential Analyses to control for the risks of random errors. We considered a P value of 0.025 or less as statistically significant. We used GRADE methodology. Our primary outcomes were all-cause mortality, serious adverse events, and health-related quality of life. We included 244 randomised clinical trials with 28,619 participants that met our inclusion criteria. We considered all trials to be at high risk of bias. Two

Duration of luteal support (DOLS with progesterone pessaries to improve the success rates in assisted conception: study protocol for a randomized controlled trial

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Gazvani Rafet

2012-07-01

Full Text Available Abstract Background Luteal support with progesterone is necessary for successful implantation of the embryo following egg collection and embryo transfer in an in-vitro fertilization (IVF cycle. Progesterone has been used for as little as 2 weeks and for as long as 12 weeks of gestation. The optimal length of treatment is unresolved at present and it remains unclear how long to treat women receiving luteal supplementation. Design The trial is a prospective, randomized, double-blind, placebo-controlled trial to investigate the effect of the duration of luteal support with progesterone in IVF cycles. Following 2 weeks standard treatment and a positive biochemical pregnancy test, this randomized control trial will allocate women to a supplementary 8 weeks treatment with vaginal progesterone or 8 weeks placebo. Further studies would be required to investigate whether additional supplementation with progesterone is beneficial in early pregnancy. Discussion Currently at the Hewitt Centre, approximately 32.5% of women have a positive biochemical pregnancy test 2 weeks after embryo transfer. It is this population that is eligible for trial entry and randomization. Once the patient has confirmed a positive urinary pregnancy test they will be invited to join the trial. Once the consent form has been completed by the patient a trial prescription sheet will be sent to pharmacy with a stated collection time. The patient can then be randomized and the drugs dispensed according to pharmacy protocol. A blood sample will then be drawn for measurement of baseline hormone levels (progesterone, estradiol, free beta-human chorionic gonadotrophin, pregnancy-associated plasma protein-A, Activin A, Inhibin A and Inhibin B. The primary outcome measure is the proportion of all randomized women that continue successfully to a viable pregnancy (at least one fetus with fetal heart rate >100 beats/minute on transabdominal/transvaginal ultrasound at 10 weeks post embryo

Supported Discharge Teams for older people in hospital acute care: a randomised controlled trial.

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Parsons, Matthew; Parsons, John; Rouse, Paul; Pillai, Avinesh; Mathieson, Sean; Parsons, Rochelle; Smith, Christine; Kenealy, Tim

2018-03-01

Supported Discharge Teams aim to help with the transition from hospital to home, whilst reducing hospital length-of-stay. Despite their obvious attraction, the evidence remains mixed, ranging from strong support for disease-specific interventions to less favourable results for generic services. To determine whether older people referred to a Supported Discharge Team have: (i) reduced length-of-stay in hospital; (ii) reduced risk of hospital readmission; and (iii) reduced healthcare costs. Randomised controlled trial with follow-up to 6 months; 103 older women and 80 men (n = 183) (mean age 79), in hospital, were randomised to receive either Supported Discharge Team or usual care. Home-based rehabilitation was delivered by trained Health Care Assistants up to four times a day, 7 days a week, under the guidance of registered nurses, allied health and geriatricians for up to 6 weeks. Participants randomised to the Supported Discharge Team spent less time in hospital during the index admission (mean 15.7 days) in comparison to usual care (mean 21.6 days) (mean difference 5.9: 95% CI 0.6, 11.3 days: P = 0.03) and spent less time in hospital in the 6 months following discharge home. Supported discharge group costs were calculated at mean NZ$10,836 (SD NZ$12,087) compared to NZ$16,943 (SD NZ$22,303) in usual care. A Supported Discharge Team can provide an effective means of discharging older people home early from hospital and can make a cost-effective contribution to managing increasing demand for hospital beds. © The Author 2017. Published by Oxford University Press on behalf of the British Geriatrics Society.All rights reserved. For permissions, please email: journals.permissions@oup.com

The effect of the support program on the resilience of female family caregivers of stroke patients: Randomized controlled trial.

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İnci, Fadime Hatice; Temel, Ayla Bayik

2016-11-01

The purpose of the study was to determine the effect of a support program on the resilience of female family caregivers of stroke patients. This is a randomized controlled trial. The sample consisted 70 female family caregivers (34 experimental, 36 control group). Data were collected three times (pretest-posttest, follow-up test). Data were collected using the demographical data form, the Family Index of Regenerativity and Adaptation-General. A significant difference was determined between the experimental and control group's follow-up test scores for relative and friend support, social support and family-coping coherence. A significant difference was determined between the experimental group's mean pretest, posttest and follow-up test scores in terms of family strain, relative and friend support, social support, family coping-coherence, family hardiness and family distress. These results suggest that the Support Program contributes to the improvement of the components of resilience of family caregivers of stroke patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Generalisierte Angststörung

NARCIS (Netherlands)

Becker, E.S.; Hoyer, J.

2005-01-01

Diagnostik und Behandlung der Generalisierten Angststörung gelten nach wie vor als schwierig, zudem ist die Wirksamkeit der Behandlung derzeit geringer als bei anderen Angststörungen. Umso wichtiger ist es, die neuen Modelle und die neuen Behandlungsmöglichkeiten bei dieser Störung kennen zu lernen.

Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study

DEFF Research Database (Denmark)

Lundh, Andreas; Barbateskovic, Marija; Hróbjartsson, Asbjørn

2010-01-01

transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals...

Effectiveness of a Technology-Based Supportive Educational Parenting Program on Parental Outcomes in Singapore: Protocol for a Randomized Controlled Trial.

Science.gov (United States)

Shorey, Shefaly; Ng, Yvonne Peng Mei; Siew, An Ling; Yoong, Joanne; Mörelius, Evalotte

2018-01-10

Supportive educational programs during the perinatal period are scarce in Singapore. There is no continuity of care available in terms of support from community care nurses in Singapore. Parents are left on their own most of the time, which results in a stressful transition to parenthood. There is a need for easily accessible technology-based educational programs that can support parents during this crucial perinatal period. The aim of this study was to describe the study protocol of a randomized controlled trial on a technology-based supportive educational parenting program. A randomized controlled two-group pretest and repeated posttest experimental design will be used. The study will recruit 118 parents (59 couples) from the antenatal clinics of a tertiary public hospital in Singapore. Eligible parents will be randomly allocated to receive either the supportive educational parenting program or routine perinatal care from the hospital. Outcome measures include parenting self-efficacy, parental bonding, postnatal depression, social support, parenting satisfaction, and cost evaluation. Data will be collected at the antenatal period, immediate postnatal period, and at 1 month and 3 months post childbirth. Recruitment of the study participants commenced in December 2016 and is still ongoing. Data collection is projected to finish within 12 months, by December 2017. This study will identify a potentially clinically useful, effective, and cost-effective supportive educational parenting program to improve parental self-efficacy and bonding in newborn care, which will then improve parents' social support-seeking behaviors, emotional well-being, and satisfaction with parenting. It is hoped that better supported and satisfied parents will consider having more children, which may in turn influence Singapore's ailing birth rate. International Standard Randomized Controlled Trial Number (ISRCTN): 48536064; https://www.isrctn.com/ISRCTN48536064 (Archived by WebCite at http

Gym-based exercise and home-based exercise with telephone support have similar outcomes when used as maintenance programs in adults with chronic health conditions: a randomised trial

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Paul Jansons

2017-07-01

Trial registration: ACTRN12610001035011. [Jansons P, Robins L, O’Brien L, Haines T (2017 Gym-based exercise and home-based exercise with telephone support have similar outcomes when used as maintenance programs in adults with chronic health conditions: a randomised trial. Journal of Physiotherapy 63: 154–160

Music-supported therapy in the rehabilitation of subacute stroke patients: a randomized controlled trial.

Science.gov (United States)

Grau-Sánchez, Jennifer; Duarte, Esther; Ramos-Escobar, Neus; Sierpowska, Joanna; Rueda, Nohora; Redón, Susana; Veciana de Las Heras, Misericordia; Pedro, Jordi; Särkämö, Teppo; Rodríguez-Fornells, Antoni

2018-04-01

The effect of music-supported therapy (MST) as a tool to restore hemiparesis of the upper extremity after a stroke has not been appropriately contrasted with conventional therapy. The aim of this trial was to test the effectiveness of adding MST to a standard rehabilitation program in subacute stroke patients. A randomized controlled trial was conducted in which patients were randomized to MST or conventional therapy in addition to the rehabilitation program. The intensity and duration of the interventions were equated in both groups. Before and after 4 weeks of treatment, motor and cognitive functions, mood, and quality of life (QoL) of participants were evaluated. A follow-up at 3 months was conducted to examine the retention of motor gains. Both groups significantly improved their motor function, and no differences between groups were found. The only difference between groups was observed in the language domain for QoL. Importantly, an association was encountered between the capacity to experience pleasure from music activities and the motor improvement in the MST group. MST as an add-on treatment showed no superiority to conventional therapies for motor recovery. Importantly, patient's intrinsic motivation to engage in musical activities was associated with better motor improvement. © 2018 New York Academy of Sciences.

An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial

Science.gov (United States)

2014-01-01

Background All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks. Subsequent support is available on request from staff in community clinics and from a telephone helpline. The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0–6 months versus a single home-visit together with subsequent standard services (the latter support was available to mothers in both study groups). Methods/Design The evaluation utilised a pragmatic preference randomised trial comparing the equivalence of outcomes for mothers and infants across the two study groups. Eligible mothers were those whose services were provided by nurses working in one of six community clinics in the metropolitan region of Adelaide. Mothers were excluded if they did not have internet access, required an interpreter, or their nurse clinician recommended that they not participate due to issues such as domestic violence or substance abuse. Randomisation was based on the service identification number sequentially assigned to infants when referred to the Child and Family Health Services from birthing units (this was done by administrative staff who had no involvement in recruiting mothers, delivering the intervention, or analyzing results for the study). Consistent with design and power calculations, 819 mothers were recruited to the trial. The primary outcomes for the trial are parents’ sense of competence and self-efficacy measured using standard self-report questionnaires. Secondary outcomes include the quality of mother-infant relationships, maternal social support, role satisfaction and maternal mental health, infant social-emotional and language development, and patterns of service utilisation. Maternal and infant outcomes will be evaluated using age-appropriate questionnaires when infants are aged <2 months

Support or competition? How online social networks increase physical activity: A randomized controlled trial

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Jingwen Zhang, PhD

2016-12-01

Full Text Available To identify what features of online social networks can increase physical activity, we conducted a 4-arm randomized controlled trial in 2014 in Philadelphia, PA. Students (n = 790, mean age = 25.2 at an university were randomly assigned to one of four conditions composed of either supportive or competitive relationships and either with individual or team incentives for attending exercise classes. The social comparison condition placed participants into 6-person competitive networks with individual incentives. The social support condition placed participants into 6-person teams with team incentives. The combined condition with both supportive and competitive relationships placed participants into 6-person teams, where participants could compare their team's performance to 5 other teams' performances. The control condition only allowed participants to attend classes with individual incentives. Rewards were based on the total number of classes attended by an individual, or the average number of classes attended by the members of a team. The outcome was the number of classes that participants attended. Data were analyzed using multilevel models in 2014. The mean attendance numbers per week were 35.7, 38.5, 20.3, and 16.8 in the social comparison, the combined, the control, and the social support conditions. Attendance numbers were 90% higher in the social comparison and the combined conditions (mean = 1.9, SE = 0.2 in contrast to the two conditions without comparison (mean = 1.0, SE = 0.2 (p = 0.003. Social comparison was more effective for increasing physical activity than social support and its effects did not depend on individual or team incentives.

The effectiveness of an online support group for members of the community with depression: a randomised controlled trial.

Directory of Open Access Journals (Sweden)

Kathleen M Griffiths

Full Text Available BACKGROUND: Internet support groups (ISGs are popular, particularly among people with depression, but there is little high quality evidence concerning their effectiveness. AIM: The study aimed to evaluate the efficacy of an ISG for reducing depressive symptoms among community members when used alone and in combination with an automated Internet-based psychotherapy training program. METHOD: Volunteers with elevated psychological distress were identified using a community-based screening postal survey. Participants were randomised to one of four 12-week conditions: depression Internet Support Group (ISG, automated depression Internet Training Program (ITP, combination of the two (ITP+ISG, or a control website with delayed access to e-couch at 6 months. Assessments were conducted at baseline, post-intervention, 6 and 12 months. RESULTS: There was no change in depressive symptoms relative to control after 3 months of exposure to the ISG. However, both the ISG alone and the combined ISG+ITP group showed significantly greater reduction in depressive symptoms at 6 and 12 months follow-up than the control group. The ITP program was effective relative to control at post-intervention but not at 6 months. CONCLUSIONS: ISGs for depression are promising and warrant further empirical investigation. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN65657330.

[Telephone support for breastfeeding by primary care: a randomised multicentre trial].

Science.gov (United States)

Balaguer Martínez, Josep Vicent; Valcarce Pérez, Inmaculada; Esquivel Ojeda, Jessica Noelia; Hernández Gil, Alicia; Martín Jiménez, María Del Pilar; Bernad Albareda, Mercè

2018-03-22

To evaluate a telephone support programme for mothers who breastfeed for the first 6 months. A randomised unmasked clinical trial was conducted in 5 urban Primary Care centres that included mothers with healthy newborns who were breastfeeding exclusively (EBF) or partially (PBF). The control group received the usual care. The intervention group also received telephone support for breastfeeding on a weekly basis for the first 2months and then every 2weeks until the sixth month. The type of breastfeeding was recorded in the usual check-up visit (1, 2, 4 and 6 months). The study included 193 patients in the intervention group, and 187 in a control group. The greatest increase in the percentage of EBF was observed at 6 months: 21.4% in the control group compared to 30.1% in the intervention group. However, in the adjusted odds ratios analysis, confidence intervals did not show statistical significance. The odds ratio at 1 month, 2 months, 4 months, and 6 months for EBF were 1.45 (0.91-2.31), 1.35 (0.87-2.08), 1.21 (0.80-1.81), and 1.58 (0.99-2.53), respectively. The odds ratio in the same age groups for any type of breastfeeding (EBF + PBF) were 1.65 (0.39-7.00), 2.08 (0.94-4.61), 1.37 (0.79-2.38), and 1.60 (0.98-2.61), respectively. Telephone intervention was not effective enough to generalise it. Copyright © 2018. Publicado por Elsevier España, S.L.U.

Successful closure of persistent oro-cutaneous fistulas by injection of autologous adipose-derived stem cells: a case report [Erfolgreiche Behandlung persistierender oro-kutaner Fisteln durch Injektion mit autologen Fettstammzellen: ein Fallbericht

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Föll, D. A.

2013-07-01

Full Text Available [english] Introduction: Oro-cutaneous fistulas are a possible complication of oro-facial surgery. If recurrent they are difficult to treat and greatly affect the patient's functional and aesthetic integrity besides carrying the risk of infection. Usage of concentrated adipose-derived stem cells for chronic wounds is a new and experimental treatment strategy, so far only applied in a few selected studies. We report the case of two oro-cutaneous fistulas in one patient treated with adipose-derived stem cells leading to closure of the fistulas.Case description: The patient was a 57-year old female immunosuppressed liver and kidney recipient who presented with a large mandibular and soft tissue defect after resection and irradiation of a squamous-cell carcinoma of the tongue base. After radical debridement, hardware removal and soft tissue reconstruction using a second free flap two oro-cutaneous fistulas reoccurred. Conventional surgical methods failed to consolidate the fistulas due to the severe radiation of the oral mucosa. Therefore autologous adipose-derived stem cells were extracted from lipoaspirate and applied in the surrounding fistula tissue in one session using the Cytori Celution system. The fistulas closed spontaneously during the postoperative course within 4 weeks and remain closed after 6 months.Conclusion: To our knowledge this is the first report of successful application of adipose-derived stem cells to two oro-cutaneous fistulas. Innovative stem cell therapy in combination with well established surgical methods can be a useful treatment strategy in certain cases.[german] Einleitung: Oro-kutane Fisteln sind eine mögliche Komplikation eines oro-fazialen Eingriffs. Bei Therapieresistenz können solche Fisteln zu hohem Leidensdruck führen und stellen eine ständige Infektionsgefahr dar. Die Applikation von konzentrierten Stammzellen aus Fettgewebe zur Behandlung chronischer Wunden ist eine neue und experimentelle Therapiestrategie

Cost-effectiveness of lumbar supports for home care workers with recurrent low back pain: an economic evaluation alongside a randomized controlled trial

NARCIS (Netherlands)

Roelofs, P.D.D.M.; Bierma-Zeinstra, S.M.A.; van Poppel, M.N.M.; van Mechelen, W.; Koes, B.W.; van Tulder, M.W.

2010-01-01

Study Design.: Economic evaluation from a societal perspective alongside a 12-months randomized-controlled trial. Objective.: To determine the cost-effectiveness of wearing a lumbar support for home care workers with recurrent low back pain (LBP) (secondary prevention). Summary of Background Data.:

The effect of social support features and gamification on a Web-based intervention for rheumatoid arthritis patients: randomized controlled trial.

Science.gov (United States)

Allam, Ahmed; Kostova, Zlatina; Nakamoto, Kent; Schulz, Peter Johannes

2015-01-09

Rheumatoid arthritis (RA) is chronic systematic disease that affects people during the most productive period of their lives. Web-based health interventions have been effective in many studies; however, there is little evidence and few studies showing the effectiveness of online social support and especially gamification on patients' behavioral and health outcomes. The aim of this study was to look into the effects of a Web-based intervention that included online social support features and gamification on physical activity, health care utilization, medication overuse, empowerment, and RA knowledge of RA patients. The effect of gamification on website use was also investigated. We conducted a 5-arm parallel randomized controlled trial for RA patients in Ticino (Italian-speaking part of Switzerland). A total of 157 patients were recruited through brochures left with physicians and were randomly allocated to 1 of 4 experimental conditions with different types of access to online social support and gamification features and a control group that had no access to the website. Data were collected at 3 time points through questionnaires at baseline, posttest 2 months later, and at follow-up after another 2 months. Primary outcomes were physical activity, health care utilization, and medication overuse; secondary outcomes included empowerment and RA knowledge. All outcomes were self-reported. Intention-to-treat analysis was followed and multilevel linear mixed models were used to study the change of outcomes over time. The best-fit multilevel models (growth curve models) that described the change in the primary outcomes over the course of the intervention included time and empowerment as time-variant predictors. The growth curve analyses of experimental conditions were compared to the control group. Physical activity increased over time for patients having access to social support sections plus gaming (unstandardized beta coefficient [B]=3.39, P=.02). Health care

Percutaneous CT-guided treatment of osteoidosteomas: combination of drill biopsy and subsequent ethanol injection; Perkutane CT-gesteuerte Behandlung von Osteoidosteomen: kombiniertes Vorgehen mit einem Hohlbohrer und nachfolgender Aethanolinjektion

Energy Technology Data Exchange (ETDEWEB)

Adam, G. [Klinik fuer Radiologische Diagnostik, RWTH Aachen (Germany); Keulers, P. [Klinik fuer Radiologische Diagnostik, RWTH Aachen (Germany); Vorwerk, D. [Klinik fuer Radiologische Diagnostik, RWTH Aachen (Germany); Heller, K.D. [Orthopaedische Klinik, RWTH Aachen (Germany); Fuezesi, L. [Inst. fuer Pathologie, RWTH Aachen (Germany); Guenther, R.W. [Klinik fuer Radiologische Diagnostik, RWTH Aachen (Germany)

1995-03-01

The purpose of this study was the clinical evaluation of a percutaneous treatment modality in patients with an osteoidosteoma. 6 patients with an osteoidosteoma of the upper (n=1) and lower (n=5) extremity which were confirmed on plain film radiographs and computed tomography underwent CT controlled drill biopsy of the nidus with subsequent injection of 96% ethanol into the biopsy channel to sclerose probably remaining remnants of the nidus. The procedure was started under local anaesthesia, but drilling of the nidus was carried out under a short general anaesthesia using ketamine. The intervention was successful in all patients. No postinterventional infection occurred and no recurrence was observed in any of the patients in a follow-up time between 0.5 and 2 years. (orig./MG) [Deutsch] Zielsetzung der Untersuchungen war die klinische Erprobung eines perkutanen Verfahrens zur Behandlung von Osteoidosteomen. Bei 6 Patienten mit einem nativradiologisch und computertomographisch nachgewiesenen Osteoidosteom im Bereich der oberen (n=1) und der unteren Extremitaet (n=5) wurde perkutan unter CT-Kontrolle der Nidus ausgebohrt und ueber den Bohrkanal 96%iger Alkohol nachinjiziert, um etwaige Nidusreste zu sklerosieren. Der Eingriff wurde in Lokalanaesthesie begonnen, die Ausbohrung des Nidus unter einer Ketanestkurznarkose durchgefuehrt. Das Vorgehen war bei allen Patienten erfolgreich. In keinem Fall wurde eine postinterventionelle Infektion beobachtet. Ueber den Nachbeobachtungszeitraum von 0,5 bis zu 2,5 Jahren trat bei keinem der Patienten ein Rezidiv auf. (orig./MG)

Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial.

Science.gov (United States)

Dam, Alieske E H; de Vugt, Marjolein E; van Boxtel, Martin P J; Verhey, Frans R J

2017-08-29

Caregivers of people with dementia (PwD) face burden, feelings of loneliness, and social isolation. Previous studies have shown promising effects of online e-health interventions. Using social media may facilitate support for dementia caregiver networks. In an iterative step-wise approach, a social support tool entitled "Inlife" was developed. This paper describes the design of a study evaluating the effects of Inlife and its process characteristics. A mixed-method, randomised controlled trial with 122 caregivers of PwD will be conducted. Participants will be assigned to either the Inlife social support intervention or a waiting-list control group. After 16 weeks, the control group will obtain access to the Inlife environment. Data will be collected at baseline (T 0 ) and at 8-week (T 1 ), 16-week (T 2 ) and 42-week follow up (T 3 ). The 16-week follow-up assessment (T 2 ) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. The primary outcomes include feelings of caregiver competence and perceived social support. The secondary outcomes include received support, feelings of loneliness, psychological complaints (e.g., anxiety, stress), and quality of life. A process evaluation, including semi-structured interviews, will be conducted to examine the internal and external validity of the intervention. Using a mixed-method design, our study will provide valuable insights into the usability, effectiveness, and factors related to implementation of the Inlife intervention. Our study results will indicate whether Inlife could be a valuable social support resource in future routine dementia care. Dutch trial register, NTR6131 . Registered on 20 October 2016.

Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial.

Science.gov (United States)

Hudson, Joanna L; Moss-Morris, Rona; Norton, Sam; Picariello, Federica; Game, David; Carroll, Amy; Spencer, Jonathan; McCrone, Paul; Hotopf, Matthew; Yardley, Lucy; Chilcot, Joseph

2017-11-01

Psychological distress is prevalent in haemodialysis (HD) patients yet access to psychotherapy remains limited. This study assessed the feasibility and acceptability of online cognitive-behavioural therapy (CBT) tailored for HD patients, with or without therapist support, for managing psychological distress. This feasibility randomised controlled trial recruited patients from a UK HD centre. Following psychological distress screens, patients with mild-moderate psychological distress (Patient Health Questionnaire PHQ-9; score: 5-19 and/or Generalised Anxiety Disorder; GAD-7 score: 5-14) who met remaining inclusion criteria were approached for consent. Consenters were individually randomised (1:1) to online-CBT or online-CBT plus three therapist support calls. Outcomes included recruitment, retention, and adherence rates. Exploratory change analyses were performed for: psychological distress, quality of life (QoL), illness perceptions, and costs. The statistician was blinded to allocation. 182 (44%) out of 410 patients approached completed psychological distress screens. 26% found screening unacceptable; a further 30% found it unfeasible. Psychological distress was detected in 101 (55%) patients, 60 of these met remaining inclusion criteria. The primary reason for ineligibility was poor computer literacy (N=17, 53%). Twenty-five patients were randomised to the supported (N=18) or unsupported arm (N=7); 92% were retained at follow-up. No differences in psychological distress or cost-effectiveness were observed. No trial adverse events occurred. Online CBT appears feasible but only for computer literate patients who identify with the label psychological distress. A definitive trial using the current methods for psychological distress screening and online care delivery is unfeasible. ClinicalTrials.gov Identifier: NCT02352870. Copyright © 2017 Elsevier Inc. All rights reserved.

Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 2): Multicenter Randomized Controlled Trial.

Science.gov (United States)

Zhu, Jiemin; Ebert, Lyn; Liu, Xiangyu; Wei, Di; Chan, Sally Wai-Chi

2018-04-30

Women undergoing chemotherapy for the treatment of breast cancer have frequently reported unmet supportive care needs. Moreover, easily accessible and innovative support is lacking. The purpose of this trial was to determine the effectiveness of an app-based breast cancer e-support program to address women's self-efficacy (primary outcome), social support, symptom distress, quality of life, anxiety, and depression. Secondary objectives included exploring the association between women's health outcomes and the breast cancer e-support usage data. A multicenter, single-blinded, randomized controlled trial was conducted. A total of 114 women with breast cancer, who were commencing chemotherapy and were able to access internet through a mobile phone, were recruited in the clinics from 2 university-affiliated hospitals in China. Women were randomized either to the intervention group (n=57) receiving breast cancer e-support plus care as usual or the control group (n=57) receiving care as usual alone. The health care team and research assistants collecting data were blinded to the women's group allocation. Bandura's self-efficacy theory and the social exchange theory guided the development of the breast cancer e-support program, which has 4 components: (1) a Learning forum, (2) a Discussion forum, (3) an Ask-the-Expert forum, and (4) a Personal Stories forum. Moderated by an experienced health care professional, the breast cancer e-support program supported women for 12 weeks covering 4 cycles of chemotherapy. Health outcomes were self-assessed through paper questionnaires in clinics at baseline before randomization (T0), after 3 (T1), and 6 months (T2) of follow-ups. Fifty-five participants in the intervention group and 49 in the control group completed the follow-up assessments (response rate: 91.2%). During the 12-week intervention, the log-in frequency ranged from 0 to 774 times (mean 54.7; SD 131.4; median 11; interquartile range, IQR 5-27), and the total usage

Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial.

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Kien Hoa Ly

Full Text Available There is need for more cost and time effective treatments for depression. This is the first randomised controlled trial in which a blended treatment--including four face-to-face sessions and a smartphone application--was compared against a full behavioural treatment. Hence, the aim of the current paper was to examine whether a blended smartphone treatment was non-inferior to a full behavioural activation treatment for depression.This was a randomised controlled non-inferiority trial (NCT01819025 comparing a blended treatment (n=46 against a full ten-session treatment (n=47 for people suffering from major depression. Primary outcome measure was the BDI-II, that was administered at pre- and post-treatment, as well as six months after the treatment.Results showed significant improvements in both groups across time on the primary outcome measure (within-group Cohen's d=1.35; CI [-0.82, 3.52] to d=1.47; CI [-0.41, 3.35]; between group d=-0.13 CI [-2.37, 2.09] and d=-0.10 CI [-2.53, 2.33]. At the same time, the blended treatment reduced the therapist time with an average of 47%.We could not establish whether the blended treatment was non-inferior to a full BA treatment. Nevertheless, this study points to that the blended treatment approach could possibly treat nearly twice as many patients suffering from depression by using a smartphone application as add-on. More studies are needed before we can suggest that the blended treatment method is a promising cost-effective alternative to regular face-to-face treatment for depression.Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support NCT01819025.

Peers versus professional training of basic life support in Syria: a randomized controlled trial.

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Abbas, Fatima; Sawaf, Bisher; Hanafi, Ibrahem; Hajeer, Mohammad Younis; Zakaria, Mhd Ismael; Abbas, Wafaa; Alabdeh, Fadi; Ibrahim, Nazir

2018-06-18

Peer training has been identified as a useful tool for delivering undergraduate training in basic life support (BLS) which is fundamental as an initial response in cases of emergency. This study aimed to (1) Evaluate the efficacy of peer-led model in basic life support training among medical students in their first three years of study, compared to professional-led training and (2) To assess the efficacy of the course program and students' satisfaction of peer-led training. A randomized controlled trial with blinded assessors was conducted on 72 medical students from the pre-clinical years (1st to 3rd years in Syria) at Syrian Private University. Students were randomly assigned to peer-led or to professional-led training group for one-day-course of basic life support skills. Sixty-four students who underwent checklist based assessment using objective structured clinical examination design (OSCE) (practical assessment of BLS skills) and answered BLS knowledge checkpoint-questionnaire were included in the analysis. There was no statistically significant difference between the two groups in delivering BLS skills to medical students in practical (P = 0.850) and BLS knowledge questionnaire outcomes (P = 0.900). Both groups showed statistically significant improvement from pre- to post-course assessment with significant statistical difference in both practical skills and theoretical knowledge (P-Value life support for medical students was beneficial and it provided a quality of education which was as effective as training conducted by professionals. This method is applicable and desirable especially in poor-resource countries and in crisis situation.

Treatment of lumbar facet joint syndrome by CT-guided intraarticular infiltration of fact joints; Behandlung des lumbalen Facettensyndroms durch CT-gesteuerte Infiltration der Zwischenwirbelgelenke

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Schleifer, J. [Knappschaftsklinik Puettlingen/Saar (Germany). Orthopaedische Abteilung; Fenzl, G. [Knappschaftsklinik Puettlingen/Saar (Germany). Orthopaedische Abteilung; Wolf, A. [Knappschaftsklinik Puettlingen/Saar (Germany). Radiologische Abteilung; Diehl, K. [Knappschaftsklinik Puettlingen/Saar (Germany). Radiologische Abteilung

1994-11-01

In 62 patients with facet syndrome a total of 205 joints were infiltrated, CT monitoring being used in all cases. Each facet joint was infiltrated with 0.3 ml bupivacaine and 0.8 ml methylprednisolone. The patients were divided into three groups. Group 1 consisted of 24 persons who had undergone lumbar disc surgery, group 2 of 23 patients with spondylarthrosis of the facet joints, and group 3 of 15 patients who had undergone lumbar disc surgery but hat additional spondylarthrosis. Very good results were defined as pain relief for longer than 4 weeks, good results as pain relief for up to 4 weeks and poor results as brief pain relief or none at all. In 27 patients facet infiltration was performed for the purpose of diagnosis. Results were significantly in group 2 than in group 1. In group 3 results were better than in group 1, but worse than in group 2. These differences were not statistical by significant. Seven patients in the diagnostic group had no pain relief, and facet syndrome was excluded. (orig.) [Deutsch] Bei 62 Patienten mit lumbalem Facettensyndrom wurden insgesamt 205 Zwischenwirbelgelenke (Facettengelenke) perkutan CT-gesteuert infiltriert. Je Gelenk wurden 0,3 ml Bupivacain und 0,8 ml Methylprednisolon intraartikulaer infiziert. Die Patienten wurden in 3 Gruppen unterteilt. Die 1. Gruppe umfasste 24 Patienten mit Postnukleotomiesyndrom, die 2. Gruppe 23 Patienten mit spondylarthrotischen Veraenderungen, die 3. Gruppe 15 bandscheibenoperierte Patienten mit zusaetzlicher Spondylarthrose. In Gruppe 2 fanden sich signifikant bessere Ergebnisse als in Gruppe 1. Gute Resultate ergab auch die dritte Gruppe, sie waren jedoch nicht signifikant besser als die der Gruppe 1. Die sorgfaeltige Auswahl der Patienten ist fuer den Erfolg der Behandlung entscheidend. Die Infiltrationsbehandlung der Zwischenwirbelgelenke hat nahezu keine Nebenwirkungen. Ausser zur Therapie wird das Verfahren diagnostisch zum Ausschluss eines Facettensyndromes im Rahmen der Abklaerung

Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II.

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Annie LeBlanc

Full Text Available Osteoporosis Choice, an encounter decision aid, can engage patients and clinicians in shared decision making about osteoporosis treatment. Its effectiveness compared to the routine provision to clinicians of the patient's estimated risk of fracture using the FRAX calculator is unknown.Patient-level, randomized, three-arm trial enrolling women over 50 with osteopenia or osteoporosis eligible for treatment with bisphosphonates, where the use of Osteoporosis Choice was compared to FRAX only and to usual care to determine impact on patient knowledge, decisional conflict, involvement in the decision-making process, decision to start and adherence to bisphosphonates.We enrolled 79 women in the three arms. Because FRAX estimation alone and usual care produced similar results, we grouped them for analysis. Compared to these, use of Osteoporosis Choice increased patient knowledge (median score 6 vs. 4, p = .01, improved understanding of fracture risk and risk reduction with bisphosphonates (p = .01 and p<.0001, respectively, had no effect on decision conflict, and increased patient engagement in the decision making process (OPTION scores 57% vs. 43%, p = .001. Encounters with the decision aid were 0.8 minutes longer (range: 33 minutes shorter to 3.0 minutes longer. There were twice as many patients receiving and filling prescriptions in the decision aid arm (83% vs. 40%, p = .07; medication adherence at 6 months was no different across arms.Supporting both patients and clinicians during the clinical encounter with the Osteoporosis Choice decision aid efficiently improves treatment decision making when compared to usual care with or without clinical decision support with FRAX results.clinical trials.gov NCT00949611.

Management of postoperative radiation injury of the urinary bladder by hyperbaric oxygen (HBO)

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Peusch-Dreyer, D.; Dreyer, K.H. [Zentrum fuer Tauch- und Ueberdruckmedizin (ZETUeM), Bremen (Germany); Mueller, C.D. [Druckkammerzentrum Magdeburg (Germany); Carl, U. [Klinik fuer Strahlentherapie und Radioonkologie, Universitaet Duesseldorf (Germany)

1998-11-01

Aim: In many case reports the success of treatment of late complications of radiotherapy with hyperbaric oxygenation (HBO) has been shown. This synopsis attempts to review HBO in the treatment of chronic radiation injury of the bladder. Patients and methods: Three female patients who had developed urge-incontinence after a Wertheim operation and combined brachy-teletherapy with cobalt-60 and afterloading and did not respond to various drug therapies, were treated with HBO to a maximum of 40 applications. Results: In all patients HBO haltered and inverted the dynamic process underlying chronic bladder changes after irradiation. Rationales for the HBO are the reduction of tissue hypoxia and the induction of neoangiogenesis. Conclusions: There are no prospective trials up to date showing the benefit of HBO to urinary disorders caused by radiation cystitis. The positive results of our retrospective study should encourage clinicians to initiate prospective studies with the use of HBO in the treatment of radiation cystitis. (orig.) [Deutsch] Ziel: Ueber die erfolgreiche Anwendung der hyperbaren Sauerstofftherapie (HBO) zur Behandlung von Strahlenspaetkomplikationen ist in zahlreichen Publikationen berichtet worden. Ziel dieser Arbeit ist es, den Einsatz der HBO bei der Behandlung von Miktionsbeschwerden bei chronisch radiogenen Harnblasenschaeden zu bewerten. Patienten und Methode: Drei Patientinnen, die nach einer kombinierten Brachyteletherapie mit Kobalt 60 und Afterloading nach Wertheim-Operation unter einer medikamentoes nicht zu beeinflussenden Urge-Inkontinenz litten, wurden der HBO mit maximal 40 Behandlungen zugefuehrt. Ergebnisse: Die HBO war bei allen Patientinnen in der Lage, den dynamischen Krankheitsprozess der Strahlenzystitis aufzuhalten und teilweise umzukehren. Grundlage hierfuer ist die Beseitigung der Gewebshypoxie. Dieses wiederum stellt die Voraussetzung fuer eine Neovaskularisation im bestrahlten Gewebe dar. Schlussfolgerung: Prospektive Studien

Project TEAMS (Talking about Eating, Activity, and Mutual Support: a randomized controlled trial of a theory-based weight loss program for couples

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Amy A. Gorin

2017-09-01

Full Text Available Abstract Background Obesity risk is shared between spouses, yet existing weight loss programs focus on individuals and not the marital dyad. Given the interdependence of weight in couples, weight management outcomes might be improved by targeting joint weight loss and the creation of an interpersonal milieu that supports long-term behavior change. According to Self-Determination Theory (SDT, greater autonomous self-regulation of behaviors, and subsequently better treatment outcomes, are observed in needs supportive environments in which personally meaningful choice is supported and criticism and control are minimized. Correlational analyses confirm these pathways in weight management, with needs support from one’s spouse or partner emerging as a distinct predictor of weight loss success. Research is now needed to establish causal links and to develop and test weight loss interventions designed to facilitate the needs supportive behavior of spouses. Methods Project TEAMS (Talking about Eating, Activity, and Mutual Support is a randomized controlled trial testing a couples-based intervention, grounded in SDT, designed to change the social context of weight loss by training spouses to provide needs support for each other’s eating and physical activity behavior. Sixty-four couples will be randomized to either 6 months of behavioral weight loss treatment informed by SDT (SDT-WL or to 6 months of standard behavioral weight loss treatment (BWL. Couples will attend weekly sessions for 6 months and will be assessed at 0, 3, 6, and 12 months. By bolstering needs support, SDT-WL is predicted to increase autonomous self-regulation and perceived competence and produce greater weight loss and maintenance than standard behavioral treatment. Exploratory analyses will examine the SDT process model prediction that the influence of needs support on treatment outcomes will be mediated by autonomous self-regulation and perceived competence. Discussion This

Effects of a standard provision versus an autonomy supportive exercise referral programme on physical activity, quality of life and well-being indicators: a cluster randomised controlled trial

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2014-01-01

Background The National Institute for Health and Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the feasibility and impact of a Self Determination Theory-based (SDT) exercise referral consultation. Methods An exploratory cluster randomised controlled trial comparing standard provision exercise referral with an exercise referral intervention grounded in Self Determination Theory. Individuals (N = 347) referred to an exercise referral scheme were recruited into the trial from 13 centres. Outcomes and processes of change measured at baseline, 3 and 6-months: Minutes of self-reported moderate or vigorous physical activity (PA) per week (primary outcome), health status, positive and negative indicators of emotional well-being, anxiety, depression, quality of life (QOL), vitality, and perceptions of autonomy support from the advisor, need satisfaction (3 and 6 months only), intentions to be active, and motivational regulations for exercise. Blood pressure and weight were assessed at baseline and 6 months. Results Perceptions of the autonomy support provided by the health and fitness advisor (HFA) did not differ by arm. Between group changes over the 6-months revealed significant differences for reported anxiety only. Within arm contrasts revealed significant improvements in anxiety and most of the Dartmouth CO-OP domains in the SDT arm at 6 months, which were not seen in the standard exercise referral group. A process model depicting hypothesized relationships between advisor autonomy support, need satisfaction and more autonomous motivation, enhanced well being and PA engagement at follow up was supported. Conclusions Significant gains in physical activity and improvements in quality of life and well-being outcomes emerged

Effectiveness of a Peer Support Programme versus Usual Care in Disease Management of Diabetes Mellitus Type 2 regarding Improvement of Metabolic Control: A Cluster-Randomised Controlled Trial.

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Johansson, Tim; Keller, Sophie; Winkler, Henrike; Ostermann, Thomas; Weitgasser, Raimund; Sönnichsen, Andreas C

2016-01-01

Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n = 337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI -0.08 to 0.36%, p = 0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p = 0.046) compared to the intervention group. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077).

Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial.

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Lamb, S E; Marsh, J L; Hutton, J L; Nakash, R; Cooke, M W

2009-02-14

Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (Aircast brace, Bledsoe boot, or 10-day below-knee cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. Patients who received the below-knee cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the cast compared with tubular compression bandage (mean difference 9%; 95% CI 2.4-15.0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between Aircast brace and tubular compression bandage was 8%; 95% CI 1.8-14.2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and

FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): protocol for a multicentre randomised feasibility trial of non-invasive respiratory support in critically ill children.

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Ramnarayan, Padmanabhan; Lister, Paula; Dominguez, Troy; Habibi, Parviz; Edmonds, Naomi; Canter, Ruth; Mouncey, Paul; Peters, Mark J

2017-06-12

Over 18 000 children are admitted annually to UK paediatric intensive care units (PICUs), of whom nearly 75% receive respiratory support (invasive and/or non-invasive). Continuous positive airway pressure (CPAP) has traditionally been used to provide first-line non-invasive respiratory support (NRS) in PICUs; however, high-flow nasal cannula therapy (HFNC), a novel mode of NRS, has recently gained popularity despite the lack of high-quality trial evidence to support its effectiveness. This feasibility study aims to inform the design and conduct of a future definitive randomised clinical trial (RCT) comparing the two modes of respiratory support. We will conduct a three-centre randomised feasibility study over 12 months. Patients admitted to participating PICUs who satisfy eligibility criteria will be recruited to either group A (primary respiratory failure) or group B (postextubation). Consent will be obtained from parents/guardians prior to randomisation in 'planned' group B, and deferred in emergency situations (group A and 'rescue' group B). Participants will be randomised (1:1) to either CPAP or HFNC using sealed, opaque envelopes, from a computer-generated randomisation sequence with variable block sizes. The study protocol specifies algorithms for the initiation, maintenance and weaning of HFNC and CPAP. The primary outcomes are related to feasibility, including the number of eligible patients in each group, feasibility of randomising >50% of eligible patients and measures of adherence to the treatment protocols. Data will also be collected on patient outcomes (eg, mortality and length of PICU stay) to inform the selection of an appropriate outcome measure in a future RCT. We aim to recruit 120 patients to the study. Ethical approval was granted by the National Research Ethics Service Committee North East-Tyne&Wear South (15/NE/0296). Study findings will be disseminated through peer-reviewed journals, national and international conferences. NCT02612415; pre

Effectiveness of personalised feedback alone or combined with peer support to improve physical activity in sedentary older Malays with type 2 diabetes: A randomised controlled trial

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Shariff-Ghazali eSazlina

2015-07-01

Full Text Available Introduction: Regular physical activity is an important aspect of self management among older people with type 2 diabetes but many remain inactive. Interventions to improve physical activity levels have been studied but few studies have evaluated the effects of personalised feedback or peer support; and there was no study on older people of Asian heritage. Hence, this trial evaluated whether personalised feedback (PF only or combined with peer support (PS improves physical activity among older Malays with type 2 diabetes (T2DM compared to usual care only. Materials and methods: A three arm randomised controlled trial was conducted in a primary healthcare clinic in Malaysia. 69 sedentary Malays aged 60 years and older with T2DM who received usual diabetes care were randomised to PF or PS interventions or as controls for 12 weeks with follow-ups at weeks 24 and 36. Intervention groups performed unsupervised walking activity and received written feedback on physical activity. The PS group also received group and telephone contacts from trained peer mentors. The primary outcome was pedometer steps. Secondary outcomes were self-reported physical activity, cardiovascular risk factors, cardiorespiratory fitness, balance, quality of life and psychosocial wellbeing. Results: 52 (75.4% completed the 36-week study. The PS group showed greater daily pedometer readings than the PF and controls (p=0.001. The PS group also had greater improvement in weekly duration (p<0.001 and frequency (p<0.001 of moderate intensity physical activity, scores on the Physical Activity Scale for Elderly (p=0.003, six minute walk test (p<0.001 and social support from friends (p=0.032 than PF and control groups. Conclusions: The findings suggest personalised feedback combined with peer support in older Malays with T2DM improved their physical activity levels, cardiorespiratory fitness and support from friends. Trial registration: Current Controlled Trials ISRCTN71447000.

Impact of food support on food security and body weight among HIV antiretroviral therapy recipients in Honduras: a pilot intervention trial.

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Palar, Kartika; Derose, Kathryn Pitkin; Linnemayr, Sebastian; Smith, Alexandria; Farías, Hugo; Wagner, Glenn; Martinez, Homero

2015-01-01

Optimal strategies to improve food security and nutrition for people living with HIV (PLHIV) may differ in settings where overweight and obesity are prevalent and cardiovascular disease risk is a concern. However, no studies among PLHIV have investigated the impact of food support on nutritional outcomes in these settings. We therefore assessed the effect of food support on food insecurity and body weight in a population of PLHIV with high prevalence of overweight and obesity. We implemented a pilot intervention trial in four government-run HIV clinics in Honduras. The trial tested the effect of a monthly household food ration plus nutrition education (n = 203), compared to nutrition education alone (n = 197), over 12 months. Participants were clinic patients receiving antiretroviral therapy (ART). Assessments were obtained at baseline, 6 and 12 months. Primary outcomes for this analysis were food security, using the validated Latin American and Caribbean Food Security Scale and body weight (kg). Thirty-one percent of participants were overweight (22%) or obese (8%) at baseline. At 6 months, the probability of severe food insecurity decreased by 48.3% (p < 0.01) in the food support group, compared to 11.6% in the education-only group (p < 0.01). Among overweight or obese participants, food support led to average weight gain of 1.13 kg (p < 0.01), while nutrition education alone was associated with average weight loss of 0.72 kg (p < 0.10). Nutrition education alone was associated with weight gain among underweight and normal weight participants. Household food support may improve food security but not necessarily nutritional status of ART recipients above and beyond nutrition education. Improving nutritional tailoring of food support and testing the impact of nutrition education should be prioritized for PLHIV in Latin America and similar settings.

The protocol of a randomized controlled trial for playgroup mothers: Reminder on Food, Relaxation, Exercise, and Support for Health (REFRESH Program

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Monteiro Sarojini MDR

2011-08-01

Full Text Available Abstract Background Mother's physical activity levels are relatively low, while their energy consumption is generally high resulting in 58% of Australian women over the age of 18 years being overweight or obese. This study aims to confirm if a low-cost, accessible playgroup based intervention program can improve the dietary and physical activity behaviours of mothers with young children. Methods/Design The current study is a randomized controlled trial lifestyle (nutrition and physical activity intervention for mothers with children aged between 0 to 5 years attending playgroups in Perth, Western Australia. Nine-hundred participants will be recruited and randomly assigned to the intervention (n = 450 and control (n = 450 groups. The study is based on the Social Cognitive Theory (SCT and the Transtheoretical Model (TTM, and the Precede-Proceed Framework incorporating goal setting, motivational interviewing, social support and self-efficacy. The six month intervention will include multiple strategies and resources to ensure the engagement and retention of participants. The main strategy is home based and will include a specially designed booklet with dietary and physical activity information, a muscle strength and flexibility exercise chart, a nutrition label reading shopping list and menu planner. The home based strategy will be supported by face-to-face dietary and physical activity workshops in the playgroup setting, posted and emailed bi-monthly newsletters, and monthly Short Message Service (SMS reminders via mobile phones. Participants in the control group receive no intervention materials. Outcome measures will be assessed using data that will be collected at baseline, six months and 12 months from participants in the control and intervention groups. Discussion This trial will add to the evidence base on the recruitment, retention and the impact of community based dietary and physical activity interventions for mothers with young children

Randomised cluster trial to support informed parental decision-making for the MMR vaccine

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Bekker Hilary

2011-06-01

Full Text Available Abstract Background In the UK public concern about the safety of the combined measles, mumps and rubella [MMR] vaccine continues to impact on MMR coverage. Whilst the sharp decline in uptake has begun to level out, first and second dose uptake rates remain short of that required for population immunity. Furthermore, international research consistently shows that some parents lack confidence in making a decision about MMR vaccination for their children. Together, this work suggests that effective interventions are required to support parents to make informed decisions about MMR. This trial assessed the impact of a parent-centred, multi-component intervention (balanced information, group discussion, coaching exercise on informed parental decision-making for MMR. Methods This was a two arm, cluster randomised trial. One hundred and forty two UK parents of children eligible for MMR vaccination were recruited from six primary healthcare centres and six childcare organisations. The intervention arm received an MMR information leaflet and participated in the intervention (parent meeting. The control arm received the leaflet only. The primary outcome was decisional conflict. Secondary outcomes were actual and intended MMR choice, knowledge, attitude, concern and necessity beliefs about MMR and anxiety. Results Decisional conflict decreased for both arms to a level where an 'effective' MMR decision could be made one-week (effect estimate = -0.54, p Conclusions Whilst both the leaflet and the parent meeting reduced parents' decisional conflict, the parent meeting appeared to enable parents to act upon their decision leading to vaccination uptake.

Support surfaces for pressure ulcer prevention.

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McInnes, Elizabeth; Jammali-Blasi, Asmara; Bell-Syer, Sally E M; Dumville, Jo C; Middleton, Victoria; Cullum, Nicky

2015-09-03

Pressure ulcers (i.e. bedsores, pressure sores, pressure injuries, decubitus ulcers) are areas of localised damage to the skin and underlying tissue. They are common in the elderly and immobile, and costly in financial and human terms. Pressure-relieving support surfaces (i.e. beds, mattresses, seat cushions etc) are used to help prevent ulcer development. This systematic review seeks to establish:(1) the extent to which pressure-relieving support surfaces reduce the incidence of pressure ulcers compared with standard support surfaces, and,(2) their comparative effectiveness in ulcer prevention. In April 2015, for this fourth update we searched The Cochrane Wounds Group Specialised Register (searched 15 April 2015) which includes the results of regular searches of MEDLINE, EMBASE and CINAHL and The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 3). Randomised controlled trials (RCTs) and quasi-randomised trials, published or unpublished, that assessed the effects of any support surface for prevention of pressure ulcers, in any patient group or setting which measured pressure ulcer incidence. Trials reporting only proxy outcomes (e.g. interface pressure) were excluded. Two review authors independently selected trials. Data were extracted by one review author and checked by another. Where appropriate, estimates from similar trials were pooled for meta-analysis. For this fourth update six new trials were included, bringing the total of included trials to 59.Foam alternatives to standard hospital foam mattresses reduce the incidence of pressure ulcers in people at risk (RR 0.40 95% CI 0.21 to 0.74). The relative merits of alternating- and constant low-pressure devices are unclear. One high-quality trial suggested that alternating-pressure mattresses may be more cost effective than alternating-pressure overlays in a UK context.Pressure-relieving overlays on the operating table reduce postoperative pressure ulcer incidence

Pregnancy, exercise and nutrition research study with smart phone app support (Pears): Study protocol of a randomized controlled trial.

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Kennelly, Maria A; Ainscough, Kate; Lindsay, Karen; Gibney, Eileen; Mc Carthy, Mary; McAuliffe, Fionnuala M

2016-01-01

Maternal adiposity confers an increased risk of GDM in pregnancy. A low glycemic index (GI) dietary intervention has been found to improve glucose homeostasis and reduce gestational weight gain. Mobile Health (mHealth) Technology-assisted interventions are becoming commonplace as an aid to treating many chronic diseases. The aim of this study is to assess the impact of a 'healthy lifestyle package' with mHealth smart phone technology as support compared with usual care on the incidence of GDM in an overweight and obese pregnant population. We propose a randomized controlled trial of an mHealth assisted healthy lifestyle intervention package versus standard obstetric care in pregnant women with a BMI ≥25kg/m(2)-39.9kg/m(2). Patients are randomized to control or intervention group in a 1:1 ratio. The intervention arm healthy lifestyle package includes a motivational counseling session to encourage behavior change, involving targeted, low GI nutritional advice and daily physical activity prescription delivered before 18weeks gestation, as well as a smart phone app to provide ongoing healthy lifestyle advice and support throughout pregnancy. The primary outcome is the incidence of GDM at 29weeks' gestation and power analysis indicates that 253 women are required in each group to detect a difference. This will be the first clinical trial to evaluate the effectiveness of a smart phone technology-assisted targeted healthy lifestyle intervention, which is grounded in behavior change theories and techniques, to support antenatal management of an overweight and obese pregnant population in preventing GDM. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical Trials

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Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ... the new approach. You also will have the support of a team of health care providers, who ...

NCI National Clinical Trials Network Structure

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Learn about how the National Clinical Trials Network (NCTN) is structured. The NCTN is a program of the National Cancer Institute that gives funds and other support to cancer research organizations to conduct cancer clinical trials.

[Clinical trials in nursing journals].

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Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

2014-01-01

Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

Two controlled trials to increase participant retention in a randomized controlled trial of mobile phone-based smoking cessation support in the United Kingdom.

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Severi, Ettore; Free, Caroline; Knight, Rosemary; Robertson, Steven; Edwards, Philip; Hoile, Elizabeth

2011-10-01

Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants' awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly. Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher. Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures. Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88-1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98. In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.

Randomised controlled trials cited in pharmaceutical advertisements targeting New Zealand health professionals: do they support the advertising claims and what is the risk of bias?

Science.gov (United States)

Ma, Alison; Parkin, Lianne

2015-09-04

To determine whether pharmaceutical advertisement claims targeting health professionals were supported by the randomised controlled trials (RCTs) cited in the advertisements, and to assess the risk of bias in those trials. Pharmaceutical advertisements were obtained from New Zealand Doctor and Pharmacy Today for the period July 2013 to June 2014. All claims made regarding efficacy, safety, and indications were identified and RCTs cited to substantiate these claims were examined. A claim was defined as supported by an RCT if the conclusions drawn in the paper were consistent with the claim. The quality of the RCT was assessed separately, using the Cochrane Risk of Bias Assessment Tool. In 25 (19%) of the 133 instances in which an RCT was cited, the published paper did not support the promotional claim. Moreover, there were only 10 (8%) instances in which the claim was supported by an RCT with a low risk of bias. Of the 78 cited RCTs, only 14% had a low risk of bias, while 49% had an unclear risk and 37% had a high risk. A high proportion of advertisements failed to meet New Zealand regulatory requirements that claims "are valid and have been substantiated".

Randomized Trial of Supported Employment Integrated With Assertive Community Treatment for Rural Adults With Severe Mental Illness

Science.gov (United States)

Gold, Paul B; Meisler, Neil; Santos, Alberto B; Carnemolla, Mark A; Williams, Olivia H; Keleher, Jennie

2006-01-01

Urban-based randomized clinical trials of integrated supported employment (SE) and mental health services in the United States on average have doubled the employment rates of adults with severe mental illness (SMI) compared to traditional vocational rehabilitation. However, studies have not yet explored if the service integrative functions of SE will be effective in coordinating rural-based services that are limited, loosely linked, and geographically dispersed. In addition, SE's ability to replicate the work outcomes of urban programs in rural economies with scarce and less diverse job opportunities remains unknown. In a rural South Carolina county, we designed and implemented a program blending Assertive Community Treatment (ACT) with an SE model, Individual Placement and Support (IPS). The ACT-IPS program operated with ACT and IPS subteams that tightly integrated vocational with mental health services within each self-contained team. In a 24-month randomized clinical trial, we compared ACT-IPS to a traditional program providing parallel vocational and mental health services on competitive work outcomes for adults with SMI (N = 143; 69% schizophrenia, 77% African American). More ACT-IPS participants held competitive jobs (64 versus 26%; p < .001, effect size [ES] = 0.38) and earned more income (median [Mdn] = $549, interquartile range [IQR] = $0–$5,145, versus Mdn = $0, IQR = $0–$40; p < .001, ES = 0.70) than comparison participants. The competitive work outcomes of this rural ACT-IPS program closely resemble those of urban SE programs. However, achieving economic self-sufficiently and developing careers probably require increasing access to higher education and jobs imparting marketable technical skills. PMID:16177278

Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial

Directory of Open Access Journals (Sweden)

Gega Lina

2012-08-01

Full Text Available Abstract Background Computerised cognitive behaviour therapy (cCBT involves standardised, automated, interactive self-help programmes delivered via a computer. Randomised controlled trials (RCTs and observational studies have shown than cCBT reduces depressive symptoms as much as face-to-face therapy and more than waiting lists or treatment as usual. cCBT’s efficacy and acceptability may be influenced by the “human” support offered as an adjunct to it, which can vary in duration and can be offered by people with different levels of training and expertise. Methods/design This is a two-by-two factorial RCT investigating the effectiveness, cost-effectiveness and acceptability of cCBT supplemented with 12 weekly phone support sessions are either brief (5–10 min or extended (20–30 min and are offered by either an expert clinician or an assistant with no clinical training. Adults with non-suicidal depression in primary care can self-refer into the study by completing and posting to the research team a standardised questionnaire. Following an assessment interview, eligible referrals have access to an 8-session cCBT programme called Beating the Blues and are randomised to one of four types of support: brief-assistant, extended-assistant, brief-clinician or extended-clinician. A sample size of 35 per group (total 140 is sufficient to detect a moderate effect size with 90% power on our primary outcome measure (Work and Social Adjustment Scale; assuming a 30% attrition rate, 200 patients will be randomised. Secondary outcome measures include the Beck Depression and Anxiety Inventories and the PHQ-9 and GAD-7. Data on clinical outcomes, treatment usage and patient experiences are collected in three ways: by post via self-report questionnaires at week 0 (randomisation and at weeks 12 and 24 post-randomisation; electronically by the cCBT system every time patients log-in; by phone during assessments, support sessions and exit interviews. Discussion

Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial

OpenAIRE

Till Beiwinkel; Stefan Hey; Olaf Bock; Wulf Rössler; Wulf Rössler; Wulf Rössler

2017-01-01

Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N = 186 smartphone users will be recruited, with an over-sampling of persons...

OpenGeneMed: a portable, flexible and customizable informatics hub for the coordination of next-generation sequencing studies in support of precision medicine trials.

Science.gov (United States)

Palmisano, Alida; Zhao, Yingdong; Li, Ming-Chung; Polley, Eric C; Simon, Richard M

2017-09-01

Trials involving genomic-driven treatment selection require the coordination of many teams interacting with a great variety of information. The need of better informatics support to manage this complex set of operations motivated the creation of OpenGeneMed. OpenGeneMed is a stand-alone and customizable version of GeneMed (Zhao et al. GeneMed: an informatics hub for the coordination of next-generation sequencing studies that support precision oncology clinical trials. Cancer Inform 2015;14(Suppl 2):45), a web-based interface developed for the National Cancer Institute Molecular Profiling-based Assignment of Cancer Therapy (NCI-MPACT) clinical trial coordinated by the NIH. OpenGeneMed streamlines clinical trial management and it can be used by clinicians, lab personnel, statisticians and researchers as a communication hub. It automates the annotation of genomic variants identified by sequencing tumor DNA, classifies the actionable mutations according to customizable rules and facilitates quality control in reviewing variants. The system generates summarized reports with detected genomic alterations that a treatment review team can use for treatment assignment. OpenGeneMed allows collaboration to happen seamlessly along the clinical pipeline; it helps reduce errors made transferring data between groups and facilitates clear documentation along the pipeline. OpenGeneMed is distributed as a stand-alone virtual machine, ready for deployment and use from a web browser; its code is customizable to address specific needs of different clinical trials and research teams. Examples on how to change the code are provided in the technical documentation distributed with the virtual machine. In summary, OpenGeneMed offers an initial set of features inspired by our experience with GeneMed, a system that has been proven to be efficient and successful for coordinating the application of next-generation sequencing in the NCI-MPACT trial. Published by Oxford University Press 2016. This

Implementing an evidence-based computerized decision support system to improve patient care in a general hospital: the CODES study protocol for a randomized controlled trial.

Science.gov (United States)

Moja, Lorenzo; Polo Friz, Hernan; Capobussi, Matteo; Kwag, Koren; Banzi, Rita; Ruggiero, Francesca; González-Lorenzo, Marien; Liberati, Elisa Giulia; Mangia, Massimo; Nyberg, Peter; Kunnamo, Ilkka; Cimminiello, Claudio; Vighi, Giuseppe; Grimshaw, Jeremy; Bonovas, Stefanos

2016-07-07

Computerized decision support systems (CDSSs) are information technology-based software that provide health professionals with actionable, patient-specific recommendations or guidelines for disease diagnosis, treatment, and management at the point-of-care. These messages are intelligently filtered to enhance the health and clinical care of patients. CDSSs may be integrated with patient electronic health records (EHRs) and evidence-based knowledge. We designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, evidence-based reminders generated at the point-of-care by a multi-specialty decision support system on clinical practice and the quality of care. We will include all the patients admitted to the internal medicine department of one large general hospital. The primary outcome is the rate at which medical problems, which are detected by the decision support software and reported through the reminders, are resolved (i.e., resolution rates). Secondary outcomes are resolution rates for reminders specific to venous thromboembolism (VTE) prevention, in-hospital all causes and VTE-related mortality, and the length of hospital stay during the study period. The adoption of CDSSs is likely to increase across healthcare systems due to growing concerns about the quality of medical care and discrepancy between real and ideal practice, continuous demands for a meaningful use of health information technology, and the increasing use of and familiarity with advanced technology among new generations of physicians. The results of our study will contribute to the current understanding of the effectiveness of CDSSs in primary care and hospital settings, thereby informing future research and healthcare policy questions related to the feasibility and value of CDSS use in healthcare systems. This trial is seconded by a specialty trial randomizing patients in an oncology setting (ONCO-CODES). ClinicalTrials.gov, https://clinicaltrials.gov/ct2

Investigating a training supporting shared decision making (IT'S SDM 2011: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Geiger Friedemann

2011-10-01

Full Text Available Background Shared Decision Making (SDM is regarded as the best practice model for the communicative challenge of decision making about treatment or diagnostic options. However, randomized controlled trials focusing the effectiveness of SDM trainings are rare and existing measures of SDM are increasingly challenged by the latest research findings. This study will 1 evaluate a new physicians' communication training regarding patient involvement in terms of SDM, 2 validate SDMMASS, a new compound measure of SDM, and 3 evaluate the effects of SDM on the perceived quality of the decision process and on the elaboration of the decision. Methods In a multi-center randomized controlled trial with a waiting control group, 40 physicians from 7 medical fields are enrolled. Each physician contributes a sequence of four medical consultations including a diagnostic or treatment decision. The intervention consists of two condensed video-based individual coaching sessions (15min. supported by a manual and a DVD. The interventions alternate with three measurement points plus follow up (6 months. Realized patient involvement is measured using the coefficient SDMMASS drawn from the Multifocal Approach to the Sharing in SDM (MAPPIN'SDM which includes objective involvement, involvement as perceived by the patient, and the doctor-patient concordance regarding their judges of the involvement. For validation purposes, all three components of SDMMASS are supplemented by similar measures, the OPTION observer scale, the Shared Decision Making Questionnaire (SDM-Q and the dyadic application of the Decisional Conflict Scale (DCS. Training effects are analyzed using t-tests. Spearman correlation coefficients are used to determine convergent validities, the influence of involvement (SDMMASS on the perceived decision quality (DCS and on the elaboration of the decision. The latter is operationalised by the ELAB coefficient from the UP24 (Uncertainty Profile, 24 items version

The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

DEFF Research Database (Denmark)

Krogh, Jesper; Saltin, Bengt; Gluud, Christian

2009-01-01

OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners or psych......: Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients, but they do support a beneficial effect of strength training on work capacity. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00103415....

Effects of a standard provision versus an autonomy supportive exercise referral programme on physical activity, quality of life and well-being indicators: a cluster randomised controlled trial.

Science.gov (United States)

Duda, Joan L; Williams, Geoffrey C; Ntoumanis, Nikos; Daley, Amanda; Eves, Frank F; Mutrie, Nanette; Rouse, Peter C; Lodhia, Rekha; Blamey, Ruth V; Jolly, Kate

2014-01-29

The National Institute for Health and Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the feasibility and impact of a Self Determination Theory-based (SDT) exercise referral consultation. An exploratory cluster randomised controlled trial comparing standard provision exercise referral with an exercise referral intervention grounded in Self Determination Theory. Individuals (N = 347) referred to an exercise referral scheme were recruited into the trial from 13 centres.Outcomes and processes of change measured at baseline, 3 and 6-months: Minutes of self-reported moderate or vigorous physical activity (PA) per week (primary outcome), health status, positive and negative indicators of emotional well-being, anxiety, depression, quality of life (QOL), vitality, and perceptions of autonomy support from the advisor, need satisfaction (3 and 6 months only), intentions to be active, and motivational regulations for exercise.Blood pressure and weight were assessed at baseline and 6 months. Perceptions of the autonomy support provided by the health and fitness advisor (HFA) did not differ by arm. Between group changes over the 6-months revealed significant differences for reported anxiety only. Within arm contrasts revealed significant improvements in anxiety and most of the Dartmouth CO-OP domains in the SDT arm at 6 months, which were not seen in the standard exercise referral group. A process model depicting hypothesized relationships between advisor autonomy support, need satisfaction and more autonomous motivation, enhanced well being and PA engagement at follow up was supported. Significant gains in physical activity and improvements in quality of life and well-being outcomes emerged in both the standard provision exercise

Cholgate - a randomized controlled trial comparing the effect of automated and on-demand decision support on the management of cardiovascular disease factors in primary care

NARCIS (Netherlands)

J.T. van Wyk (Jacobus); M.A.M. van Wijk (Marc); P.W. Moorman (Peter); M. Mosseveld (Mees); J. van der Lei (Johan)

2003-01-01

textabstractAutomated and on-demand decision support systems integrated into an electronic medical record have proven to be an effective implementation strategy for guidelines. Cholgate is a randomized controlled trial comparing the effect of automated and on-demand decision

Effectiveness of comprehensive social support interventions among elderly patients with tuberculosis in communities in China: a community-based trial.

Science.gov (United States)

Li, Xuhui; Wang, Bin; Tan, Dixin; Li, Mengyu; Zhang, Dandan; Tang, Cong; Cai, Xiaonan; Yan, Yaqiong; Zhang, Sheng; Jin, Bo; Yu, Songlin; Liang, Xunchang; Chu, Qian; Xu, Yihua

2018-05-01

With the increasing of ageing population, tuberculosis in the elderly brings a challenge for the tuberculosis (TB) control in China. Enough social support can promote the treatment adherence and outcome of the elderly patients with TB. Exploring effective interventions to improve the social support of patients is of great significance for TB management and control. A community-based, repeated measurement trial was conducted. Patients with TB >65 years of age were allocated into the intervention or control group. Patients in the intervention group received comprehensive social support interventions, while those in the control group received health education alone. The social support level of patients was measured at baseline and at the first, third and sixth months during the intervention to assess the effectiveness of comprehensive social support interventions. A total of 201 patients were recruited into the study. Compared with the control group, social support for patients in the intervention group increased significantly over time (β group*time =0.61, Psupport (β group*time =0.15, Psupport (β group*time =0.32, Psupport utilisation (β group*time =0.16, Psupport interventions, can improve the social support for elderly patients with TB compared with single health education. ChiCTR-IOR-16009232. © 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.

The impact of the carer support needs assessment tool (CSNAT in community palliative care using a stepped wedge cluster trial.

Directory of Open Access Journals (Sweden)

Samar M Aoun

Full Text Available Family caregiving towards the end-of-life entails considerable emotional, social, financial and physical costs for caregivers. Evidence suggests that good support can improve caregiver psychological outcomes. The primary aim of this study was to investigate the impact of using the carer support needs assessment tool (CSNAT, as an intervention to identify and address support needs in end of life home care, on family caregiver outcomes. A stepped wedge design was used to trial the CSNAT intervention in three bases of Silver Chain Hospice Care in Western Australia, 2012-14. The intervention consisted of at least two visits from nurses (2-3 weeks apart to identify, review and address caregivers' needs. The outcome measures for the intervention and control groups were caregiver strain and distress as measured by the Family Appraisal of Caregiving Questionnaire (FACQ-PC, caregiver mental and physical health as measured by SF-12v2, and caregiver workload as measured by extent of caregiver assistance with activities of daily living, at baseline and follow up. Total recruitment was 620. There was 45% attrition for each group between baseline and follow-up mainly due to patient deaths resulting in 322 caregivers completing the study (233 in the intervention group and 89 in the control group. At follow-up, the intervention group showed significant reduction in caregiver strain relative to controls, p=0.018, d=0.348 (95% CI 0.25 to 0.41. Priority support needs identified by caregivers included knowing what to expect in the future, having time for yourself in the day and dealing with your feelings and worries. Despite the challenges at the clinician, organisational and trial levels, the CSNAT intervention led to an improvement in caregiver strain. Effective implementation of an evidence-informed and caregiver-led tool represents a necessary step towards helping palliative care providers better assess and address caregiver needs, ensuring adequate family

Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial.

Science.gov (United States)

van Gaalen, Johanna L; Bakker, Moira J; van Bodegom-Vos, Leti; Snoeck-Stroband, Jiska B; Assendelft, Willem J J; Kaptein, Ad A; van der Meer, Victor; Taube, Christian; Thoonen, Bart P; Sont, Jacob K

2012-11-21

Internet-based self-management (IBSM) support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS): dissemination of the IBSM program; intermediate strategy (IS): MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals); and extended strategy (ES): IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions) are primarily targeted at general practices, randomisation will occur at practice level.In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations); self-management related outcomes (health education impact, medication adherence, and illness perceptions); and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption. Follow-up is six months per patient. This study

Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials

Science.gov (United States)

Bekelman, Justin E.; Deye, James A.; Vikram, Bhadrasain; Bentzen, Soren M.; Bruner, Deborah; Curran, Walter J.; Dignam, James; Efstathiou, Jason A.; FitzGerald, T. J.; Hurkmans, Coen; Ibbott, Geoffrey S.; Lee, J. Jack; Merchant, Timothy E.; Michalski, Jeff; Palta, Jatinder R.; Simon, Richard; Ten Haken, Randal K.; Timmerman, Robert; Tunis, Sean; Coleman, C. Norman; Purdy, James

2012-01-01

Background In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute (NCI) sponsored a two day workshop to examine the challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. Lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities like proton beam therapy, and the international harmonization of clinical trial QA. Results Four recommendations were made: 1) Develop a tiered (and more efficient) system for radiotherapy QA and tailor intensity of QA to clinical trial objectives. Tiers include (i) general credentialing, (ii) trial specific credentialing, and (iii) individual case review; 2) Establish a case QA repository; 3) Develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and 4) Explore the feasibility of consolidating clinical trial QA in the United States. Conclusion Radiotherapy QA may impact clinical trial accrual, cost, outcomes and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. PMID:22425219

Results of a pilot randomised controlled trial to measure the clinical and cost effectiveness of peer support in increasing hope and quality of life in mental health patients discharged from hospital in the UK.

Science.gov (United States)

Simpson, Alan; Flood, Chris; Rowe, Julie; Quigley, Jody; Henry, Susan; Hall, Cerdic; Evans, Richard; Sherman, Paul; Bowers, Len

2014-02-05

Mental health patients can feel anxious about losing the support of staff and patients when discharged from hospital and often discontinue treatment, experience relapse and readmission to hospital, and sometimes attempt suicide. The benefits of peer support in mental health services have been identified in a number of studies with some suggesting clinical and economic gains in patients being discharged. This pilot randomised controlled trial with economic evaluation aimed to explore whether peer support in addition to usual aftercare for patients during the transition from hospital to home would increase hope, reduce loneliness, improve quality of life and show cost effectiveness compared with patients receiving usual aftercare only, with follow-up at one and three-months post-discharge. A total of 46 service users were recruited to the study; 23 receiving peer support and 23 in the care-as-usual arm. While this pilot trial found no statistically significant benefits for peer support on the primary or secondary outcome measures, there is an indication that hope may be further increased in those in receipt of peer support. The total cost per case for the peer support arm of the study was £2154 compared to £1922 for the control arm. The mean difference between costs was minimal and not statistically significant. However, further analyses demonstrated that peer support has a reasonably high probability of being more cost effective for a modest positive change in the measure of hopelessness. Challenges faced in recruitment and follow-up are explored alongside limitations in the delivery of peer support. The findings suggest there is merit in conducting further research on peer support in the transition from hospital to home consideration should be applied to the nature of the patient population to whom support is offered; the length and frequency of support provided; and the contact between peer supporters and mental health staff. There is no conclusive evidence to

Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial.

Science.gov (United States)

Beck, Anne Marie; Gøgsig Christensen, Annette; Stenbæk Hansen, Birthe; Damsbo-Svendsen, Signe; Kreinfeldt Skovgaard Møller, Tina; Boll Hansen, Eigil; Keiding, Hans

2014-08-28

Older adults in nursing home and home-care are a particularly high-risk population for weight loss or poor nutrition. One negative consequence of undernutrition is increased health care costs. Several potentially modifiable nutritional risk factors increase the likelihood of weight loss or poor nutrition. Hence a structured and multidisciplinary approach, focusing on the nutritional risk factors and involving e.g. dieticians, occupational therapists, and physiotherapist, may be necessary to achieve benefits. Up till now a few studies have been done evaluating the cost-effectiveness of nutritional support among undernourished older adults and none of these have used such a multidisciplinary approach. An 11 week cluster randomized trial to assess the cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care, identified by screening with the Eating validation Scheme. Before start of the study there will be performed a train-the-trainer intervention involving educated nutrition coordinators.In addition to the nutrition coordinator, the participants assigned to the intervention group strategy will receive multidisciplinary nutrition support. Focus will be on treatment of the potentially modifiable nutritional risk factors identified by screening, by involving physiotherapist, registered dietician, and occupational therapist, as relevant and independent of the municipality's ordinary assessment and referral system.The primary outcome parameter will be change in quality of life (by means of Euroquol-5D-3L). Secondary outcomes will be: physical performance (chair stand), nutritional status (weight, Body Mass Index and hand-grip strength), oral care, fall incidents, hospital admissions, rehabilitation stay, moving to nursing homes (for participants from home-care), use of social services and mortality.An economic evaluation will be conducted to evaluate the cost-effectiveness of the multidisciplinary

Prophylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial.

Science.gov (United States)

Lye, David C; Archuleta, Sophia; Syed-Omar, Sharifah F; Low, Jenny G; Oh, Helen M; Wei, Yuan; Fisher, Dale; Ponnampalavanar, Sasheela S L; Wijaya, Limin; Lee, Linda K; Ooi, Eng-Eong; Kamarulzaman, Adeeba; Lum, Lucy C; Tambyah, Paul A; Leo, Yee-Sin

2017-04-22

Dengue is the commonest vector-borne infection worldwide. It is often associated with thrombocytopenia, and prophylactic platelet transfusion is widely used despite the dearth of robust evidence. We aimed to assess the efficacy and safety of prophylactic platelet transfusion in the prevention of bleeding in adults with dengue and thrombocytopenia. We did an open-label, randomised, superiority trial in five hospitals in Singapore and Malaysia. We recruited patients aged at least 21 years who had laboratory-confirmed dengue (confirmed or probable) and thrombocytopenia (≤20 000 platelets per μL), without persistent mild bleeding or any severe bleeding. Patients were assigned (1:1), with randomly permuted block sizes of four or six and stratified by centre, to receive prophylactic platelet transfusion in addition to supportive care (transfusion group) or supportive care alone (control group). In the transfusion group, 4 units of pooled platelets were given each day when platelet count was 20 000 per μL or lower; supportive care consisted of bed rest, fluid therapy, and fever and pain medications. The primary endpoint was clinical bleeding (excluding petechiae) by study day 7 or hospital discharge (whichever was earlier), analysed by intention to treat. Safety outcomes were analysed according to the actual treatment received. This study was registered with ClinicalTrials.gov, number NCT01030211, and is completed. Between April 29, 2010, and Dec 9, 2014, we randomly assigned 372 patients to the transfusion group (n=188) or the control group (n=184). The intention-to-treat analysis included 187 patients in the transfusion group (one patient was withdrawn immediately) and 182 in the control group (one was withdrawn immediately and one did not have confirmed or probable dengue). Clinical bleeding by day 7 or hospital discharge occurred in 40 (21%) patients in the transfusion group and 48 (26%) patients in the control group (risk difference -4·98% [95% CI -15·08 to

Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

Science.gov (United States)

Bruner, Deborah Watkins; Bryan, Charlene J.; Aaronson, Neil; Blackmore, C. Craig; Brundage, Michael; Cella, David; Ganz, Patricia A.; Gotay, Carolyn; Hinds, Pamela S.; Kornblith, Alice B.; Movsas, Benjamin; Sloan, Jeff; Wenzel, Lari; Whalen, Giles

2016-01-01

Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need

Percutaneous mechanical atherectomy for treatment of peripheral arterial occlusive disease; Perkutane mechanische Atherektomie zur Behandlung der peripheren arteriellen Verschlusskrankheit

Energy Technology Data Exchange (ETDEWEB)

Buecker, A.; Minko, P.; Massmann, A.; Katoh, M. [Universitaetsklinikum des Saarlandes, Klinik fuer Diagnostische und Interventionelle Radiologie, Homburg (Germany)

2010-01-15

Blutversorgung durch chirurgische oder minimalinvasive Verfahren. Unter den letzteren Therapieoptionen koennen die Ballondilatation und Stentung als die meist verbreiteten Techniken angesehen werden. Aber auch juengere Techniken wie der Einsatz von Kryoplastie, Laserangioplastie, medikamentenbeschichteten Stents oder Ballons sowie Brachytherapie oder die Atherektomie werden eingesetzt, wobei die Auflistung keinen Anspruch auf Vollstaendigkeit erhebt. Die Vielzahl der verschiedenen Behandlungsmethoden belegt eindruecklich, dass noch kein durchschlagender Therapieerfolg mit einer einzelnen Methode erzielt werden konnte. So zeigen die beiden Techniken der Ballondilatation und Stentung verbesserungswuerdige Langzeitergebnisse, was die Suche nach weiteren Methoden zur Behandlung der PAVK angeregt hat. Die Atherektomie stellt eine solche alternative Behandlungsmethode der PAVK dar. Prinzipiell bezeichnet der Begriff ''Atherektomie'' die Entfernung von Atheromgewebe. Die ''perkutane Atherektomie'' benoetigt hierzu gegenueber chirurgischen Verfahren keine Gefaesseroeffnung sondern bewerkstelligt die Atherektomie mittels dedizierter Systeme ueber einen minimalinvasiven Zugang. Man unterscheidet 2 verschiedene grundsaetzliche Typen der mechanischen Atherektomie: direktionale und rotierende Systeme. (orig.)

Finding harmony so the music plays on: pragmatic trial design considerations to promote organizational sustainment of an empirically-supported behavior therapy.

Science.gov (United States)

Hartzler, Bryan; Peavy, K Michelle; Jackson, T Ron; Carney, Molly

2016-01-22

Pragmatic trials of empirically-supported behavior therapies may inform clinical and policy decisions concerning therapy sustainment. This retrospective trial design paper describes and discusses pragmatic features of a hybrid type III implementation/effectiveness trial of a contingency management (CM) intervention at an opioid treatment program. Prior reporting (Hartzler et al., J Subst Abuse Treat 46:429-438, 2014; Hartzler, Subst Abuse Treat Prev Policy 10:30, 2015) notes success in recruiting program staff for voluntary participation, durable impacts of CM training on staff-level outcomes, provisional setting implementation of the intervention, documentation of clinical effectiveness, and post-trial sustainment of CM. Six pragmatic design features, and both scientific and practical bases for their inclusion in the trial, are presented: (1) a collaborative intervention design process, (2) voluntary recruitment of program staff for therapy training and implementation, (3) serial training outcome assessments, with quasi-experimental staff randomization to either single or multiple baseline assessment conditions, (4) designation of a 90-day period immediately after training in which the setting implemented the intervention on a provisional basis, (5) inclusive patient eligibility for receipt of the CM intervention, and (6) designation of two staff as local implementation leaders to oversee clinical/administrative issues in provisional implementation. Each pragmatic trial design feature is argued to have contributed to sustainment of CM. Contributions implicate the building of setting proprietorship for the CM intervention, culling of internal staff expertise in its delivery, iterative use of assessment methods that limited setting burden, documentation of setting-specific clinical effectiveness, expanded penetration of CM among staff during provisional implementation, and promotion of setting self-reliance in the oversight of sustainable implementation procedures

Support and Assessment for Fall Emergency Referrals (SAFER 1: cluster randomised trial of computerised clinical decision support for paramedics.

Directory of Open Access Journals (Sweden)

Helen Anne Snooks

Full Text Available To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS for paramedics attending older people who fall.Cluster trial randomised by paramedic; modelling.13 ambulance stations in two UK emergency ambulance services.42 of 409 eligible paramedics, who attended 779 older patients for a reported fall.Intervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture.Effectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care.Further emergency contacts or death within one month.Costs and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness.17 intervention paramedics used CCDS for 54 (12.4% of 436 participants. They referred 42 (9.6% to falls services, compared with 17 (5.0% of 343 participants seen by 19 control paramedics [Odds ratio (OR 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72; quality of life (mean SF12 differences: MCS -0.74, 95% CI -2.83 to +1.28; PCS -0.13, 95% CI -1.65 to +1.39 and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52. However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3. Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without.Intervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture.ISRCTN Register ISRCTN

Lumbar supports for prevention and treatment of low back pain

DEFF Research Database (Denmark)

Van Tulder, M W; Jellema, P; van Poppel, M N

2000-01-01

BACKGROUND: Lumbar supports are used in the treatment of low back pain patients to make the impairment and disability vanish or decrease. Lumbar supports are also used to prevent the onset of low back pain (primary prevention) or to prevent recurrences of a low back pain episode (secondary...... 1999, and the Embase database up to September 1998. We also screened references given in relevant reviews and identified controlled trials, and used Science Citation Index to identify additional controlled trials. SELECTION CRITERIA: Controlled clinical trials that reported on any type of lumbar...... types of treatment or no intervention. No evidence was found on the effectiveness of lumbar supports for secondary prevention. The systematic review of therapeutic trials showed that there is limited evidence that lumbar supports are more effective than no treatment, while it is still unclear if lumbar...

Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial.

Science.gov (United States)

Hartnett, Dan; Murphy, Edel; Kehoe, Elizabeth; Agyapong, Vincent; McLoughlin, Declan M; Farren, Conor

2017-05-29

Alcohol use disorders (AUDs) and mood disorders commonly co-occur, and are associated with a range of negative outcomes for patients. Mobile phone technology has the potential to provide personalised support for such patients and potentially improve outcomes in this difficult-to-treat cohort. The aim of this study is to examine whether receiving supporting SMS text messages, following discharge from an inpatient dual diagnosis treatment programme, has a positive impact on mood and alcohol abstinence in patients with an AUD and a comorbid mood disorder. The present study is a single-blind randomised controlled trial. Patients aged 18-70 years who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV Axis I will be randomised to receive twice-daily supportive SMS text messages for 6 months plus treatment as usual, or treatment as usual alone, and will be followed-up at 3, 6, 9 and 12 months postdischarge. Primary outcome measures will include changes from baseline in cumulative abstinence duration, which will be expressed as the proportion of days abstinent from alcohol in the preceding 90 days, and changes from baseline in Beck Depression Inventory scores. The trial has received full ethical approval from the St. Patrick's Hospital Research Ethics Committee (protocol 13/14). Results of the trial will be disseminated through peer-reviewed journal articles and at academic conferences. NCT02404662; Pre-results. © 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.

Effectiveness of web-based self-disclosure peer-to-peer support for weight loss: randomized controlled trial.

Science.gov (United States)

Imanaka, Mie; Ando, Masahiko; Kitamura, Tetsuhisa; Kawamura, Takashi

2013-07-09

Obesity is one of the most common public health problems in the industrialized world as a cause of noncommunicable diseases. Although primarily used for one-on-one communication, email is available for uninterrupted support for weight loss, but little is known about the effects of dietitian group counseling for weight control via the Internet. We developed a Web-based self-disclosure health support (WSHS) system for weight loss. This study aims to compare the effect of weight change between those using the WSHS and those using the email health support (EHS). This study was designed as an open prospective individual randomized controlled trial. Eligible participants were aged 35 to 65 years with a body mass index (BMI) of ≥25.0 in their latest health examination. Participants were randomly assigned to either the WSHS group or the EHS group. Thirteen registered dietitians under the direction of a principal dietitian each instructed 6 to 8 participants from the respective groups. All participants in the WSHS group could receive nutritional advice and calculate their nutritive intake from a photograph of a meal on their computer screen from the Internet sent to them by their dietitian, receive supervision from the registered dietitian, and view fellow participants' weight changes and lifestyle modifications. In the EHS group, a participant could receive one-on-one nutritional advice and calculate his/her nutritive intake from the photograph of a meal on computer screen sent by email from his/her dietitian, without being able to view fellow participants' status. The follow-up period was 12 weeks for both groups. The primary outcome measure was change in body weight. The secondary outcome measure included changes in BMI and waist circumference. The intergroup comparison of the changes before and after intervention was evaluated using analysis of covariance. A total of 193 participants were randomly assigned to either the WSHS group (n=97) or the EHS group (n=96). Ten

Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

Directory of Open Access Journals (Sweden)

S. Kannan

2016-03-01

Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial.

Science.gov (United States)

Sussman, Jonathan; Bainbridge, Daryl; Whelan, Timothy J; Brazil, Kevin; Parpia, Sameer; Wiernikowski, Jennifer; Schiff, Susan; Rodin, Gary; Sergeant, Myles; Howell, Doris

2018-05-01

Better coordination of supportive services during the early phases of cancer care has been proposed to improve the care experience of patients. We conducted a randomized trial to test a community-based nurse-led coordination of care intervention in cancer patients. Surgical practices were cluster randomized to a control group involving usual care practices or a standardized nursing intervention consisting of an in-person supportive care assessment with ongoing support to meet identified needs, including linkage to community services. Newly diagnosed breast and colorectal cancer patients within 7 days of cancer surgery were eligible. The primary outcome was the patient-reported outcome (PRO) of continuity of care (CCCQ) measured at 3 weeks. Secondary outcomes included unmet supportive care needs (SCNS), quality of life (EORTC QLQ-C30), health resource utilization, and level of uncertainty with care trajectory (MUIS) at 3 and/or 8 weeks. A total of 121 breast and 72 colorectal patients were randomized through 28 surgical practices. There was a small improvement in the informational domain of continuity of care (difference 0.29 p = 0.05) and a trend to less emergency room use (15.8 vs 7.1%) (p = 0.07). There were no significant differences between groups on unmet need, quality of life, or uncertainty. We did not find substantial gaps in the PROs measured immediately following surgery for breast and colorectal cancer patients. The results of this study support a more targeted approach based on need and inform future research focused on improving navigation during the initial phases of cancer treatment. ClinicalTrials.gov Identifier: NCT00182234. SONICS-Effectiveness of Specialist Oncology Nursing.

Psychological Aspects in the Treatment of Chronic Low Back Pain in Germany: A Review.

Science.gov (United States)

Roch, S; Hampel, P

2016-10-01

Bei chronischen, nicht spezifischen Rückenschmerzen haben psychische Komorbiditäten deutlich zugenommen, sodass im Rahmen einer multimodalen Behandlung zunehmend auch psychotherapeutische Behandlungsansätze implementiert werden. Ziel dieses Reviews war es, die aktuelle Forschung zu psychologischen Aspekten bei der Behandlung von chronischen Rückenschmerzen zu thematisieren. Dazu wurde eine selektive Literaturrecherche durchgeführt, um Studien aus Deutschland zu identifizieren, die in den letzten 5 Jahren veröffentlicht wurden. Dabei wurden 12 Artikel von 5 Forschergruppen gefunden, die unterschiedliche Aspekte der stationären, teilstationären und ambulanten Rehabilitation sowie der Nachsorge thematisierten. Die Evidenz für die Effektivität von psychologischer Behandlung bei chronischen Rückenschmerzen ist in den letzten Jahren gestiegen, gerade im Bereich der Nachsorge ist jedoch weitere Forschung für eine erfolgreiche Implementierung notwendig. © Georg Thieme Verlag KG Stuttgart · New York.

The obstetrical and postpartum benefits of continuous support during childbirth.

Science.gov (United States)

Scott, K D; Klaus, P H; Klaus, M H

1999-12-01

The purpose of this article is to review the evidence regarding the effectiveness of continuous support provided by a trained laywoman (doula) during childbirth on obstetrical and postpartum outcomes. Twelve individual randomized trials have compared obstetrical and postpartum outcomes between doula-supported women and women who did not receive doula support during childbirth. Three meta-analyses, which used different approaches, have been performed on the results of the clinical trials. Emotional and physical support significantly shortens labor and decreases the need for cesarean deliveries, forceps and vacuum extraction, oxytocin augmentation, and analgesia. Doula-supported mothers also rate childbirth as less difficult and painful than do women not supported by a doula. Labor support by fathers does not appear to produce similar obstetrical benefits. Eight of the 12 trials report early or late psychosocial benefits of doula support. Early benefits include reductions in state anxiety scores, positive feelings about the birth experience, and increased rates of breastfeeding initiation. Later postpartum benefits include decreased symptoms of depression, improved self-esteem, exclusive breastfeeding, and increased sensitivity of the mother to her child's needs. The results of these 12 trials strongly suggest that doula support is an essential component of childbirth. A thorough reorganization of current birth practices is in order to ensure that every woman has access to continuous emotional and physical support during labor.

Langzeitevaluation eines psychologischen Trainings für adipöse Kinder und ihre Eltern (TAKE)

OpenAIRE

Roth, Binia; Munsch, Simone; Meyer, Andrea H.

2011-01-01

Verhaltenstherapeutische Eltern-Kind-Programme haben bisher die besten Effekte bei der Behandlung kindlicher Adipositas gezeigt. Mit TAKE (Training adipöser Kinder und ihrer Eltern) stellen wir eine psychologiebasierte Behandlung vor, die nicht nur Bewegung, Ernährung und Essverhalten als Elemente einschließt, sondern auch psychische Faktoren wie Selbstwertgefühl, Körperbild, soziale Kompetenzen und Hänseleien sowohl mit den Eltern als auch mit den Kindern behandelt. Aktuell liegen die Langze...

The effects of intervention based on supportive leadership behaviour on Iranian nursing leadership performance: a randomized controlled trial.

Science.gov (United States)

Shirazi, Mandana; Emami, Amir Hossein; Mirmoosavi, Seyed Jamal; Alavinia, Seyed Mohammad; Zamanian, Hadi; Fathollahbeigi, Faezeh; Masiello, Italo

2016-04-01

To assess the effects of a workshop on supportive leadership behaviour (SLB) on the performance of head nurses, using a randomized controlled trial design. The effect of transformational leadership on SLB in nursing management is emphasised. A total of 110 head nurses working at university hospitals were included randomly in two control and intervention groups. The head nurses in the intervention group participated in supportive leadership training, but the control group did not. Performance in supportive leadership was assessed with a validated instrument, which six subordinates used to assess their head nurse (n = 731). There was a significant difference in SLB scores from baseline to the 3 month follow-up (P leadership behaviour, particularly the interactive multifaceted training, improved the leadership performance of the head nurses who participated in this study. Health policy decision makers should apply SLB, which is a significant leadership style, to improve the outcomes in other groups of health-care management, such as physicians. Future studies are needed to investigate the effects of such workshops in longer periods of follow up. © 2015 John Wiley & Sons Ltd.

Post-trial apomorphine at an autoreceptor dose level can eliminate apomorphine conditioning and sensitization: support for the critical role of dopamine in re-consolidation.

Science.gov (United States)

Carrera, Marinete Pinheiro; Carey, Robert J; Cruz Dias, Flávia Regina; dos Santos Sampaio, Maria de Fátima; de Matos, Liana Wermelinger

2013-01-01

Re-exposure to conditioned drug stimuli triggers re-consolidation processes. In the present study post-trial apomorphine treatments were administered in order to interact with the re-consolidation of an apomorphine conditioned/sensitized locomotor response. A low (0.05 mg/kg) and a high (2.0mg/kg) dose were used to inhibit or to enhance dopamine activity, respectively. Initially, groups received 5 daily apomorphine (2.0mg/kg)/vehicle treatments either paired or unpaired to open-field placement. The paired treatments generated a progressive locomotor response. Subsequently, all groups received a 5 min non-drug test for conditioning and a conditioned locomotor response was observed in the paired group. The groups received another apomorphine (2.0mg/kg)/vehicle treatment as a re-induction treatment. At this stage the post-trial protocol was initiated. One set of paired, unpaired and vehicle groups were given a low dose of apomorphine (0.05 mg/kg) post-trial; another set received a high dose of apomorphine (2.0mg/kg) post-trial. The remaining group set received vehicle post-trial. The low dose post-trial treatment eliminated the conditioned and sensitized locomotor response and the high dose post-trial treatment enhanced the conditioned and sensitized locomotor response. The efficacy of the post-trial apomorphine treatments to modify the conditioned and the sensitized response after a brief non-drug exposure to test cues supports the proposition that exteroceptive cues control conditioning and sensitization and that the interoceptive drug cues make little or no associational contribution to apomorphine conditioning and sensitization. In addition, the findings point to the importance of dopamine activation in both the acquisition and re-consolidation of conditioning processes. Copyright © 2012 Elsevier B.V. All rights reserved.

Multimedia support for improving preoperative patient education: a randomized controlled trial using the example of radical prostatectomy.

Science.gov (United States)

Huber, Johannes; Ihrig, Andreas; Yass, Mohammed; Bruckner, Tom; Peters, Tim; Huber, Christian G; Konyango, Beryl; Lozankovski, Novica; Stredele, Regina J F; Moll, Peter; Schneider, Meike; Pahernik, Sascha; Hohenfellner, Markus

2013-01-01

Growing evidence supports the use of multimedia presentations for informing patients. Therefore, we supported preoperative education by adding a multimedia tool and examined the effects in a randomized controlled trial. We randomized German-speaking patients scheduled for radical prostatectomy at our center to receive either a multimedia-supported (MME) or a standard education (SE). Outcomes were measured in a structured interview. Primary outcome was patient satisfaction. In addition, we applied validated instruments to determine anxiety and measures of decision-making. Results were given by mean and standard deviation. For comparison of groups we used t test and chi-square test. For an explorative analysis we applied multivariate logistic regression. We randomized 203 patients to receive MME (n=102) or SE (n=101). Complete satisfaction with preoperative education was more frequent in the MME group (69 vs 52%, p=.016) and patients after MME reported more questions (5.7 vs 4.2, p=.018). There was no difference concerning the duration of talks and the number of recalled risks. However, perceived knowledge was higher after MME (1.3 vs 1.6, p=.037). Anxiety and measures of decision-making were comparable. Patients judged the multimedia tool very positive, and 74% of the MME group thought that their preoperative education had been superior to SE. Multimedia support should be considered worthwhile for improving the informed consent process before surgery (www.germanctr.de; DRKS00000096).

An interactive health communication application for supporting parents managing childhood long-term conditions: outcomes of a randomized controlled feasibility trial.

Science.gov (United States)

Swallow, Veronica M; Knafl, Kathleen; Santacroce, Sheila; Campbell, Malcolm; Hall, Andrew G; Smith, Trish; Carolan, Ian

2014-12-03

Families living with chronic or long-term conditions such as chronic kidney disease (CKD), stages 3-5, face multiple challenges and respond to these challenges in various ways. Some families adapt well while others struggle, and family response to a condition is closely related to outcome. With families and professionals, we developed a novel condition-specific interactive health communication app to improve parents' management ability-the online parent information and support (OPIS) program. OPIS consists of a comprehensive mix of clinical caregiving and psychosocial information and support. The purpose of this study was to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population, and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5. Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care, and fathers' involvement between groups. We recruited 55 parents of 39 children (42% of eligible families). Of those, about three-quarters of intervention group parents (19/26, 73%) and control group parents (22/29, 76%) were retained through completion of 20-week data collection. The overall retention rate was 41/55 (75%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks

Controlled rehabilitative and supportive care intervention trials in patients with high-grade gliomas and their caregivers

DEFF Research Database (Denmark)

Piil, K; Juhler, M; Jakobsen, J

2016-01-01

and Embase were searched for literature published from 1995 to May 2013. Data from eight studies were reviewed for substantive methods and results. Methodological quality was described and assessed using the scoring system for appraising mixed methods research and concomitantly appraising qualitative......, quantitative and mixed methods primary studies in mixed study reviews. RESULTS: The search yielded 914 unique publications, of which 9 were classified eligible for this review. There is preliminary evidence that cognitive group therapy improves memory skills in patients with high-grade gliomas, early physical....... CONCLUSIONS: As evidence is beginning to emerge, there is a need for well-designed longitudinal and randomised controlled trials of non-pharmacological interventions in high-grade glioma patients and their caregivers in order to develop clinical guidelines for supportive and rehabilitative approaches...

A cluster randomized controlled platform trial comparing group MEmory specificity training (MEST) to group psychoeducation and supportive counselling (PSC) in the treatment of recurrent depression.

Science.gov (United States)

Werner-Seidler, Aliza; Hitchcock, Caitlin; Bevan, Anna; McKinnon, Anna; Gillard, Julia; Dahm, Theresa; Chadwick, Isobel; Panesar, Inderpal; Breakwell, Lauren; Mueller, Viola; Rodrigues, Evangeline; Rees, Catrin; Gormley, Siobhan; Schweizer, Susanne; Watson, Peter; Raes, Filip; Jobson, Laura; Dalgleish, Tim

2018-06-01

Impaired ability to recall specific autobiographical memories is characteristic of depression, which when reversed, may have therapeutic benefits. This cluster-randomized controlled pilot trial investigated efficacy and aspects of acceptability, and feasibility of MEmory Specificity Training (MEST) relative to Psychoeducation and Supportive Counselling (PSC) for Major Depressive Disorder (N = 62). A key aim of this study was to determine a range of effect size estimates to inform a later phase trial. Assessments were completed at baseline, post-treatment and 3-month follow-up. The cognitive process outcome was memory specificity. The primary clinical outcome was symptoms on the Beck Depression Inventory-II at 3-month follow-up. The MEST group demonstrated greater improvement in memory specificity relative to PSC at post-intervention (d = 0.88) and follow-up (d = 0.74), relative to PSC. Both groups experienced a reduction in depressive symptoms at 3-month follow-up (d = 0.67). However, there was no support for a greater improvement in depressive symptoms at 3 months following MEST relative to PSC (d = -0.04). Although MEST generated changes on memory specificity and improved depressive symptoms, results provide no indication that MEST is superior to PSC in the resolution of self-reported depressive symptoms. Implications for later-phase definitive trials of MEST are discussed. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps in a Medicaid managed care plan: study protocol

Directory of Open Access Journals (Sweden)

Ratanawongsa Neda

2012-01-01

Full Text Available Abstract Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps. Methods/Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252, primary outcomes will be

Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol

Science.gov (United States)

2012-01-01

Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). Methods/Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

Directory of Open Access Journals (Sweden)

Rachel G. Greenberg

2018-03-01

In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Nutrition support in hospitalised adults at nutritional risk

DEFF Research Database (Denmark)

Feinberg, Joshua; Nielsen, Emil Eik; Korang, Steven Kwasi

2017-01-01

International Clinical Trials Registry Platform (www.who.int/ictrp); ClinicalTrials.gov; Turning Research Into Practice (TRIP); Google Scholar; and BIOSIS, as well as relevant bibliographies of review articles and personal files. All searches are current to February 2016. SELECTION CRITERIA: We include...... methodology. Our primary outcomes were all-cause mortality, serious adverse events, and health-related quality of life. MAIN RESULTS: We included 244 randomised clinical trials with 28,619 participants that met our inclusion criteria. We considered all trials to be at high risk of bias. Two trials accounted...... experimental intervention (12 trials); general nutrition support (9 trials); and fortified food (2 trials). The control interventions were treatment as usual (122 trials); no intervention (107 trials); and placebo (15 trials). In 204/244 trials, the intervention lasted three days or more.We found no evidence...

Effect of a computer-guided, quality improvement program for cardiovascular disease risk management in primary health care: the treatment of cardiovascular risk using electronic decision support cluster-randomized trial.

Science.gov (United States)

Peiris, David; Usherwood, Tim; Panaretto, Kathryn; Harris, Mark; Hunt, Jennifer; Redfern, Julie; Zwar, Nicholas; Colagiuri, Stephen; Hayman, Noel; Lo, Serigne; Patel, Bindu; Lyford, Marilyn; MacMahon, Stephen; Neal, Bruce; Sullivan, David; Cass, Alan; Jackson, Rod; Patel, Anushka

2015-01-01

Despite effective treatments to reduce cardiovascular disease risk, their translation into practice is limited. Using a parallel arm cluster-randomized controlled trial in 60 Australian primary healthcare centers, we tested whether a multifaceted quality improvement intervention comprising computerized decision support, audit/feedback tools, and staff training improved (1) guideline-indicated risk factor measurements and (2) guideline-indicated medications for those at high cardiovascular disease risk. Centers had to use a compatible software system, and eligible patients were regular attendees (Aboriginal and Torres Strait Islander people aged ≥ 35 years and others aged ≥ 45 years). Patient-level analyses were conducted using generalized estimating equations to account for clustering. Median follow-up for 38,725 patients (mean age, 61.0 years; 42% men) was 17.5 months. Mean monthly staff support was improved overall risk factor measurements (62.8% versus 53.4% risk ratio; 1.25; 95% confidence interval, 1.04-1.50; P=0.02), but there was no significant differences in recommended prescriptions for the high-risk cohort (n=10,308; 56.8% versus 51.2%; P=0.12). There were significant treatment escalations (new prescriptions or increased numbers of medicines) for antiplatelet (17.9% versus 2.7%; Pquality improvement intervention, requiring minimal support, improved cardiovascular disease risk measurement but did not increase prescription rates in the high-risk group. Computerized quality improvement tools offer an important, albeit partial, solution to improving primary healthcare system capacity for cardiovascular disease risk management. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336630. Australian New Zealand Clinical Trials Registry No. 12611000478910. © 2015 American Heart Association, Inc.

The ANU WellBeing study: a protocol for a quasi-factorial randomised controlled trial of the effectiveness of an Internet support group and an automated Internet intervention for depression

Directory of Open Access Journals (Sweden)

Mackinnon Andrew J

2010-03-01

Full Text Available Abstract Background Recent projections suggest that by the year 2030 depression will be the primary cause of disease burden among developed countries. Delivery of accessible consumer-focused evidenced-based services may be an important element in reducing this burden. Many consumers report a preference for self-help modes of delivery. The Internet offers a promising modality for delivering such services and there is now evidence that automated professionally developed self-help psychological interventions can be effective. By contrast, despite their popularity, there is little evidence as to the effectiveness of Internet support groups which provide peer-to-peer mutual support. Methods/Design Members of the community with elevated psychological distress were randomised to receive one of the following: (1 Internet Support Group (ISG intervention, (2 a multi-module automated psychoeducational and skills Internet Training Program (ITP, (3 a combination of the ISG and ITP, or (4 an Internet Attention Control website (IAC comprising health and wellbeing information and question and answer modules. Each intervention was 12 weeks long. Assessments were conducted at baseline, post-intervention, 6 and 12 months to examine depressive symptoms, social support, self-esteem, quality of life, depression literacy, stigma and help-seeking for depression. Participants were recruited through a screening postal survey sent to 70,000 Australians aged 18 to 65 years randomly selected from four rural and four metropolitan regions in Australia. Discussion To our knowledge this study is the first randomised controlled trial of the effectiveness of a depression ISG. Trial registration Current Controlled Trials ISRCTN65657330.

When enough is enough: how the decision was made to stop the FEAST trial: data and safety monitoring in an African trial of Fluid Expansion As Supportive Therapy (FEAST) for critically ill children.

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Todd, Jim; Heyderman, Robert S; Musoke, Philippa; Peto, Tim

2013-03-26

In resource-rich countries, bolus fluid expansion is routinely used for the treatment of poor perfusion and shock, but is less commonly used in many African settings. Controversial results from the recently completed FEAST (Fluid Expansion As Supportive Therapy) trial in African children have raised questions about the use of intravenous bolus fluid for the treatment of shock. Prior to the start of the trial, the Independent data monitoring committee (IDMC) developed stopping rules for the proof of benefit that bolus fluid resuscitation would bring. Although careful safety monitoring was put in place, there was less expectation that bolus fluid expansion would be harmful and differential stopping rules for harm were not formulated.In July 2010, two protocol amendments were agreed to increase the sample size from 2,880 to 3,600 children, and to increase bolus fluid administration. There was a non-significant trend against bolus treatment, but although the implications were discussed, the IDMC did not comment on the results, or on the amendments, in order to avoid inadvertent partial unblinding of the study.In January 2011, the trial was stopped for futility, as the combined intervention arms had significantly higher mortality (relative risk 1.46, 95% CI 1.13 to 1.90, P = 0.004) than the control arm. The stopping rule for proof of benefit was not achieved, and the IDMC stopped the trial with a lower level of significance (P = 0.01) due to futility and an increased risk of mortality from bolus fluid expansion in children enrolled in the trial. The basis for this decision was that the local standard of care was not to use bolus fluid for the care of children with shock in these African countries, and this was a different standard of care to that used in the UK. These decisions emphasize two important principles: firstly, the IDMC should avoid inadvertent unblinding of the trial by commenting on amendments, and secondly, when considering stopping a trial, the IDMC

Randomized trial of a smartphone mobile application compared to text messaging to support smoking cessation.

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Buller, David B; Borland, Ron; Bettinghaus, Erwin P; Shane, James H; Zimmerman, Donald E

2014-03-01

Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Young adult smokers 18-30 years old (n = 102) participated in a randomized pretest-posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and quitting behavior (quit attempts, point-prevalence, 30-day point-prevalence, and continued abstinence) were assessed in posttests. Overall, 60% of smokers used mobile services (REQ-Mobile, 61%, mean of 128.5 messages received; onQ, 59%, mean of 107.8 messages), and 75% evaluated REQ-Mobile as user-friendly. A majority of smokers reported being abstinent at posttest (6 weeks, 53% of completers; 12 weeks, 66% of completers [44% of all cases]). Also, 37% (25%of all cases) reported 30-day point-prevalence abstinence, and 32% (22% of all cases) reported continuous abstinence at 12 weeks. OnQ produced more abstinence (ptext messaging. Text messaging may work better because it is simple, well known, and delivered to a primary inbox. These advantages may disappear as smokers become more experienced with new handsets. Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging.

Role of radiotherapy in the treatment of multiple myeloma; Wertigkeit der Radiotherapie in der Behandlung des multiplen Myeloms

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Mose, S.; Pfitzner, D.; Rahn, A.; Nierhoff, C.; Schiemann, M.; Boettcher, H.D. [Frankfurt Univ. (Germany). Klinik fuer Strahlentherapie und Nuklearmedizin

2000-11-01

suppose that in multiple myeloma the local response to radiation is supported by a favorable performance status and simultaneous chemotherapy. Irradiation treatment does not change prognosis regarding overall survival. (orig.) [German] Die Radiotherapie nimmt im Rahmen der Schmerztherapie, die Behandlung von (drohenden) Frakturen und von Myelonkompressionen eine wichtige Rolle im palliativen Konzept ein. Ziel der vorliegenden retrospektiven Arbeit ist es, anhand dieser Indikationen den Effekt der Strahlentherapie auf Analgesie, Rekalzifizierung und neurologische Symptomatik am eigenen Patientenkollektiv aufzuzeigen und moegliche Einflussfaktoren auf den Therapieeffekt zu evaluieren. Patienten und Methoden: Vom 1.1.1988 bis 31.12.1998 wurden 42 Patienten (19 Frauen, 23 Maenner) im Alter von 46 bis 85 Jahren (Median: 64,9 Jahre) in 71 Zielvolumina aufgrund einer bestehenden Symptomatik (67/71: Ossaere Schmerzen, 45/71: Fraktur/-gefahr, 13/71: Rueckenmarkkompression) radiotherapiert (Median 36 Gy, 2 bis 3 Gy 2-mal/Woche). Die Zeit zwischen Diagnose und erster Bestrahlung betrug im Median 11,9 Monate (0,3 bis 90 Monate). Zum Zeitpunkt der ersten Radiotherapie befanden sich fuenf Patienten im Stadium II, 37 im Stadium III nach Salmon/Durie; der Karnofsky-Index lag im Median bei 70% (40 bis 90%). Ergebnisse: Im Verlauf der mindestens sechsmonatigen Nachbeobachtungszeit zeigte sich bei 85% der Zielvolumina eine komplette bzw. partielle Analgesie; es wurden 8,8% Schmerzrezidive gesehen. Eine roentgenologisch verifizierte Rekalzifizierung wurde in 26/56 (46,4%) auswertbaren Laesionen beobachtet; 17,9% waren progredient. In 22,3% der initial frakturgefaehrdeten Laesionen (4/18) kam es posttherapeutsich zu Frakturen. Eine simultane Chemotherapie sowie ein Karnofsky-Index{>=}70 wirkten sich signifikant positiv auf das Therapieansprechen aus. Eine Symptomreduktion nach Rueckenmarkkompression (nach Findley 1987) wurde bei 7/13 (53,8%) der Patienten erreicht. Das mediane Ueberleben

Effectiveness of a Hospital-Based Work Support Intervention for Female Cancer Patients – A Multi-Centre Randomised Controlled Trial

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Tamminga, Sietske J.; Verbeek, Jos H. A. M.; Bos, Monique M. E. M.; Fons, Guus; Kitzen, Jos J. E. M.; Plaisier, Peter W.; Frings-Dresen, Monique H. W.; de Boer, Angela G. E. M.

2013-01-01

Objective One key aspect of cancer survivorship is return-to-work. Unfortunately, many cancer survivors face problems upon their return-to-work. For that reason, we developed a hospital-based work support intervention aimed at enhancing return-to-work. We studied effectiveness of the intervention compared to usual care for female cancer patients in a multi-centre randomised controlled trial. Methods Breast and gynaecological cancer patients who were treated with curative intent and had paid work were randomised to the intervention group (n = 65) or control group (n = 68). The intervention involved patient education and support at the hospital and improvement of communication between treating and occupational physicians. In addition, we asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan. Outcomes at 12 months of follow-up included rate and time until return-to-work (full or partial), quality of life, work ability, work functioning, and lost productivity costs. Time until return-to-work was analyzed with Kaplan-Meier survival analysis. Results Return-to-work rates were 86% and 83% (p = 0.6) for the intervention group and control group when excluding 8 patients who died or with a life expectancy of months at follow-up. Median time from initial sick leave to partial return-to-work was 194 days (range 14–435) versus 192 days (range 82–465) (p = 0.90) with a hazard ratio of 1.03 (95% CI 0.64–1.6). Quality of life and work ability improved statistically over time but did not differ statistically between groups. Work functioning and costs did not differ statistically between groups. Conclusion The intervention was easily implemented into usual psycho-oncological care and showed high return-to-work rates. We failed to show any differences between groups on return-to-work outcomes and quality of life scores. Further research is needed to study which aspects of

Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

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Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

2016-04-01

The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662

The UK clinical research network--has it been a success for dermatology clinical trials?

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Thomas, Kim S; Koller, Karin; Foster, Katharine; Perdue, Jo; Charlesworth, Lisa; Chalmers, Joanne R

2011-06-16

Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks) using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales), and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

Social support and education groups for single mothers: a randomized controlled trial of a community-based program.

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Lipman, Ellen L; Boyle, Michael H

2005-12-06

Members of families headed by single mothers are at increased risk of psychosocial disadvantage and mental health problems. We assessed the effect of a community-based program of social support and education groups for single mothers of young children on maternal well-being and parenting. We recruited 116 single mothers of children 3 to 9 years old through community advertisements. Eligible mothers were randomly assigned either to participate in a 10-week program of group sessions (1.5 hours per week) offering social support and education, with a parallel children's activity group, or to receive a standard list of community resources and the option to participate in group sessions at the end of the follow-up period. Interviewers blinded to the randomization collected assessment data from all mothers at baseline and at 3 follow-up visits (immediately after the intervention and at 3 and 6 months after the intervention). Outcome measures were self-reported mood, self-esteem, social support and parenting. Between February 2000 and April 2003, the program was offered to 9 groups of single mothers. Most of the mothers in the trial reported high levels of financial and mental health problems. In the short term (after the intervention), mothers in the intervention group had improved scores for mood (p effect = 0.55) and self-esteem (p effect = 0.29) compared with mothers in the control group; scores for the other 2 measures did not differ between the groups. Growth curve analysis of program effects over the follow-up period showed improvement in all 4 outcomes, with no significant difference between the intervention and control groups. This community-based program of group sessions offering social support and education to low-income single mothers had positive short-term effects on mood and self-esteem but not on social support and parenting. Longer follow-up showed attenuation of these effects.

Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial.

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Dennis, C-L; Hodnett, E; Kenton, L; Weston, J; Zupancic, J; Stewart, D E; Kiss, A

2009-01-15

To evaluate the effectiveness of telephone based peer support in the prevention of postnatal depression. Multisite randomised controlled trial. Seven health regions across Ontario, Canada. 701 women in the first two weeks postpartum identified as high risk for postnatal depression with the Edinburgh postnatal depression scale and randomised with an internet based randomisation service. Proactive individualised telephone based peer (mother to mother) support, initiated within 48-72 hours of randomisation, provided by a volunteer recruited from the community who had previously experienced and recovered from self reported postnatal depression and attended a four hour training session. Edinburgh postnatal depression scale, structured clinical interview-depression, state-trait anxiety inventory, UCLA loneliness scale, and use of health services. After web based screening of 21 470 women, 701 (72%) eligible mothers were recruited. A blinded research nurse followed up more than 85% by telephone, including 613 at 12 weeks and 600 at 24 weeks postpartum. At 12 weeks, 14% (40/297) of women in the intervention group and 25% (78/315) in the control group had an Edinburgh postnatal depression scale score >12 (chi(2)=12.5, P<0.001; number need to treat 8.8, 95% confidence interval 5.9 to 19.6; relative risk reduction 0.46, 95% confidence interval 0.24 to 0.62). There was a positive trend in favour of the intervention group for maternal anxiety but not loneliness or use of health services. For ethical reasons, participants identified with clinical depression at 12 weeks were referred for treatment, resulting in no differences between groups at 24 weeks. Of the 221 women in the intervention group who received and evaluated their experience of peer support, over 80% were satisfied and would recommend this support to a friend. Telephone based peer support can be effective in preventing postnatal depression among women at high risk. ISRCTN 68337727.

A randomized clinical trial of diabetes self-management for Mexican Americans: Are there serendipitous health benefits for supporters of study participants?

Directory of Open Access Journals (Sweden)

Sharon A Brown

2017-01-01

Full Text Available Objectives: Studies of social support in diabetes have focused on the effects of support on the person with type 2 diabetes. We explored diabetes prevention effects of a culturally tailored diabetes self-management intervention in individuals without diabetes who were supporters of intervention participants. Methods: This is a secondary analysis of data from a randomized clinical trial that involved 256 Mexican Americans with diabetes. Each study participant designated a supporter—spouse, relative, friend—who attended intervention sessions and assisted participants in attaining effective diabetes self-management. Supporter’s glycosylated hemoglobin (A1C data were tracked for 1 year to determine diabetes conversion rates in supporters without diabetes at baseline. Results: Fewer individuals in the intervention group (n = 9 converted to an A1C above the 7% threshold, compared to the 1-year wait-listed control group (n = 16. We found a statistically significant difference (p = .021 at 12 months in the number of individuals whose A1C was ⩽8%, with fewer supporters above threshold in the intervention group (reduction of 48%. Supporters in the intervention group with prediabetes, based on baseline A1C, experienced a slight reduction in A1C, while control group supporters with prediabetes experienced an increase. Discussion: The results suggest that there are potential benefits for family members and other supporters of persons with diabetes who participated in diabetes self-management programs.

Management of data from clinical trials using the ArchiMed system.

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Duftschmid, Georg; Gall, Walter; Eigenbauer, Ernst; Dorda, Wolfgang

2002-06-01

Clinical trials constitute a key source of medical research and are therefore conducted on a regular basis at university hospitals. The professional execution of trials requires, among other things, a repertoire of tools that support efficient data management. Tasks that are essential for efficient data management in clinical trials include the following: the design of the trial database, the design of electronic case report forms, recruiting patients, collection of data, and statistical analysis. The present article reports the manner in which these tasks are supported by the ArchiMed system at the University of Vienna and Graz Medical Schools. ArchiMed is customized for clinical end users, allowing them to autonomously manage their clinical trials without having to consult computer experts. An evaluation of the ArchiMed system in 12 trials recently conducted at the University of Vienna Medical School shows that the individual system functions can be usefully applied for data management in clinical trials.

Future vision for the quality assurance of oncology clinical trials

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Thomas eFitzGerald, MD

2013-03-01

Full Text Available The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.

Chinese herbal medicine for cancer-related fatigue: a systematic review of randomized clinical trials.

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Su, Chun-Xiang; Wang, Li-Qiong; Grant, Suzanne J; Liu, Jian-Ping

2014-06-01

To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.

Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol.

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Ratanawongsa, Neda; Handley, Margaret A; Quan, Judy; Sarkar, Urmimala; Pfeifer, Kelly; Soria, Catalina; Schillinger, Dean

2012-01-26

Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with

Using Mobile Health to Improve Social Support for Low-Income Latino Patients with Diabetes: A Mixed-Methods Analysis of the Feasibility Trial of TExT-MED + FANS.

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Burner, Elizabeth; Lam, Chun Nok; DeRoss, Rebecca; Kagawa-Singer, Marjorie; Menchine, Michael; Arora, Sanjay

2018-01-01

Social support interventions can improve diabetes self-care, particularly for Latinos, but are time and resource intensive. Mobile health may overcome these barriers by engaging and training supporters remotely. We conducted a randomized controlled feasibility trial of emergency department patients with diabetes to determine the feasibility of enrolling patients and supporters, acceptability of the intervention, and preliminary efficacy results to power a larger trial. All patients received an existing mHealth curriculum (TExT-MED). After identifying a supporter, patients were randomized to intervention: supporters receiving FANS (family and friends network support), a text message support curriculum synchronized to patient messages, or control: supporters receiving a mailed pamphlet of the same information. Participants followed up at 3 months. FANS intervention participants came to postintervention interviews as part of a qualitative analysis. We enrolled 44 patients (22 per arm) and followed up 36 at 3 months. Participants were positive about the program. FANS intervention improved HbA1c (intervention mean decreased from 10.4% to 9.0% vs. from 10.1% to 9.5%, delta -0.8%, confidence interval [CI] -0.4 to 2, P = 0.30), self-monitoring of glucose (intervention increased 1.6 days/week vs. control decreased 2 days/week, delta 2.3 days/week, CI 4-0.6, P = 0.02), and physical activity (mean Godin leisure time activity score improved 16.1 vs. decreased 9.6 for control, delta 25.7, CI 49.2-2.3, P = 0.10). In qualitative analysis, patients reported improved motivation, behaviors, and relationships. Supporters reported making healthier decisions for themselves. mHealth is a feasible, acceptable, and promising avenue to improve social support and diabetes outcomes.

Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial

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Nelson, Lyndsay A; Wallston, Kenneth A; Kripalani, Sunil; Greevy Jr, Robert A; Elasy, Tom A; Bergner, Erin M; Gentry, Chad K

2018-01-01

Background Nonadherence to self-care is common among patients with type 2 diabetes (T2D) and often leads to severe complications. Moreover, patients with T2D who have low socioeconomic status and are racial/ethnic minorities disproportionately experience barriers to adherence and poor outcomes. Basic phone technology (text messages and phone calls) provides a practical medium for delivering content to address patients’ barriers to adherence; however, trials are needed to explore long-term and sustainable effects of mobile phone interventions among diverse patients. Objective The aim of this study is to evaluate the effects of mobile phone–based diabetes support interventions on self-care and hemoglobin A1c (HbA1c) among adults with T2D using a 3-arm, 15-month randomized controlled trial with a Type 1 hybrid effectiveness-implementation approach. The intervention arms are (1) Rapid Encouragement/Education And Communications for Health (REACH) and (2) REACH + Family-focused Add-on for Motivating Self-care (FAMS). Methods We recruited primary care patients with T2D (N=512) from Federally Qualified Health Centers and an academic medical center, prioritizing recruitment of publicly insured and minority patients from the latter. Eligible patients were prescribed daily diabetes medication and owned a cell phone with text messaging capability. We excluded patients whose most recent HbA1c result within 12 months was <6.8% to support detection of intervention effects on HbA1c. Participants were randomly assigned to REACH only, REACH + FAMS, or the control condition. REACH provides text messages tailored to address patient-specific barriers to medication adherence based on the Information-Motivation-Behavioral skills model, whereas FAMS provides monthly phone coaching with related text message content focused on family and friend barriers to diet and exercise adherence. We collect HbA1c and self-reported survey data at baseline and at 3, 6, and 12 months, and again at 15

Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies.

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Sanchez, Ana M; Denny, Thomas N; O'Gorman, Maurice

2014-07-01

This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of

Chiropractic Treatment for Gastrointestinal Problems: A Systematic Review of Clinical Trials

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E Ernst

2011-01-01

Full Text Available Many chiropractors believe that chiropractic treatments are effective for gastrointestinal disorders. The aim of the present systematic review was to critically evaluate the evidence from controlled clinical trials supporting or not supporting this notion. Six electronic databases were searched for relevant studies. No limits were applied to language or publication date. Prospective, controlled, clinical trials of any type of chiropractic treatment for any type of gastrointestinal problem, except infant colic, were included. Only two trials were found – one was a pilot study, and the other had reached a positive conclusion; however, both had serious methodological flaws. There is no supportive evidence that chiropractic is an effective treatment for gastrointestinal disorders.

Application of remote sensing to agricultural field trials

NARCIS (Netherlands)

Clevers, J.G.P.W.

1986-01-01

Remote sensing techniques enable quantitative information about a field trial to be obtained instantaneously and non-destructively. The aim of this study was to identify a method that can reduce inaccuracies in field trial analysis, and to identify how remote sensing can support and/or

CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial.

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Mendelson, Monique; Vivodtzev, Isabelle; Tamisier, Renaud; Laplaud, David; Dias-Domingos, Sonia; Baguet, Jean-Philippe; Moreau, Laurent; Koltes, Christian; Chavez, Léonidas; De Lamberterie, Gilles; Herengt, Frédéric; Levy, Patrick; Flore, Patrice; Pépin, Jean-Louis

2014-11-01

Obstructive sleep apnea (OSA) has been associated with hypertension, which is one of the intermediary mechanisms leading to increased cardiovascular morbidity. This study aimed at evaluating the effects of a combination of continuous positive airway pressure (CPAP) and telemedicine support on blood pressure (BP) reduction in high cardiovascular risk OSA patients. A multi-center randomized controlled trial that compared standard CPAP care and CPAP care and a telemedicine intervention. Sleep clinics in France. 107 adult (18-65 years old) OSA patients (AHI > 15 events/h) with a high cardiovascular risk (cardiovascular SCORE > 5% or secondary prevention). Patients were randomized to either standard care CPAP (n = 53) or CPAP and telemedicine (n = 54). Patients assigned to telemedicine were equipped with a smartphone for uploading BP measurements, CPAP adherence, sleepiness, and quality of life data; in return, they received pictograms containing health-related messages. The main outcome was home self-measured BP and secondary outcomes were cardiovascular risk evolution, objective physical activity, CPAP adherence, sleepiness and quality of life. Self-measured BP did not improve in either group (telemedicine or standard care). Patients in primary prevention showed greater BP reduction with CPAP treatment than those in secondary prevention. CPAP treatment supported by telemedicine alone did not improve blood pressure and cardiovascular risk in high cardiovascular risk OSA patients. This study emphasizes the need for diet and physical activity training programs in addition to CPAP when aiming at decreasing cardiometabolic risk factors in these patients. ClinicalTrials.gov identifier: NCT01226641.

The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

DEFF Research Database (Denmark)

Krogh, Jesper; Saltin, Bengt; Gluud, Christian

2009-01-01

OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners......: Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients, but they do support a beneficial effect of strength training on work capacity. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00103415....... or psychiatrists and were eligible if they fulfilled the International Classification of Diseases, Tenth Revision, criteria for unipolar depression and were aged between 18 and 55 years. Patients (N = 165) were allocated to supervised strength, aerobic, or relaxation training during a 4-month period. The primary...

The power of social connection and support in improving health: lessons from social support interventions with childbearing women

Directory of Open Access Journals (Sweden)

Small Rhonda

2011-11-01

Full Text Available Abstract Background and objective Social support interventions have a somewhat chequered history. Despite evidence that social connection is associated with good health, efforts to implement interventions designed to increase social support have produced mixed results. The aim of this paper is to reflect on the relationship between social connectedness and good health, by examining social support interventions with mothers of young children and analysing how support was conceptualised, enacted and valued, in order to advance what we know about providing support to improve health. Context and approach First, we provide a brief recent history of social support interventions for mothers with young children and we critically examine what was intended by ‘social support’, who provided it and for which groups of mothers, how support was enacted and what was valued by women. Second, we examine the challenges and promise of lay social support approaches focused explicitly on companionship, and draw on experiences in two cluster randomised trials which aimed to improve the wellbeing of mothers. One trial involved a universal approach, providing befriending opportunities for all mothers in the first year after birth, and the other a targeted approach offering support from a ‘mentor mother’ to childbearing women experiencing intimate partner violence. Results Interventions providing social support to mothers have most often been directed to women seen as disadvantaged, or ‘at risk’. They have also most often been enacted by health professionals and have included strong elements of health education and/or information, almost always with a focus on improving parenting skills for better child health outcomes. Fewer have involved non-professional ‘supporters’, and only some have aimed explicitly to provide companionship or a listening ear, despite these aspects being what mothers receiving support have said they valued most. Our trial

Leitlinie für die Diagnose, Prävention und Behandlung des Handekzems

DEFF Research Database (Denmark)

Diepgen, Thomas L.; Andersen, Klaus E.; Chosidow, Oliver

2015-01-01

-searching). In addition to the evidence- and consensus-based recommendation on the treatment of HE, the guidelines cover mainly consensus-based diagnostic aspects and preventive measures (primary and secondary prevention). Treatment recommendations include non-pharmacological interventions, topical, physical and systemic...... treatments. Topical corticosteroids are recommended as first line treatment in the management of HE, however continuous long-term treatment beyond six weeks only when necessary and under careful medical supervision. Alitretinoin is recommended as a second line treatment (relative to topical corticosteroids......) for patients with severe chronic HE. Randomized control trials (RCT) are missing for other used systemic treatments and comparison of systemic drugs in “head-to-head” RCTs are needed. The guidelines development group is a working group of the European Society of Contact Dermatitis (ESCD) and has carefully...

The UK clinical research network - has it been a success for dermatology clinical trials?

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Charlesworth Lisa

2011-06-01

Full Text Available Abstract Background Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS. Methods This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. Results In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Conclusions Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales, and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

Quit in General Practice: a cluster randomised trial of enhanced in-practice support for smoking cessation

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Zwar Nicholas

2010-08-01

Full Text Available Abstract Background This study will test the uptake and effectiveness of a flexible package of smoking cessation support provided primarily by the practice nurse (PN and tailored to meet the needs of a diversity of patients. Methods/Design This study is a cluster randomised trial, with practices allocated to one of three groups 1 Quit with Practice Nurse 2 Quitline referral 3 GP usual care. PNs from practices randomised to the intervention group will receive a training course in smoking cessation followed by access to mentoring. GPs from practices randomised to the Quitline referral group will receive information about the study and the process of written referral and GPs in the usual care group will receive information about the study. Eligible patients are those aged 18 and over presenting to their GP who are daily or weekly smokers and who are able to give informed consent. Patients on low incomes in all three groups will be able to access free nicotine patches. Primary outcomes are sustained abstinence and point prevalence abstinence at the three month and 12 month follow-up points; and incremental cost effectiveness ratios at 12 months. Process evaluation on the reach and acceptability of the intervention approached will be collected through Computer Assisted Telephone Interviews (CATI with patients and semi-structured interviews with PNs and GPs. The primary analysis will be by intention to treat. Cessation outcomes will be compared between the three arms at three months and 12 month follow-up using multiple logistic regression. The incremental cost effectiveness ratios will be estimated for the 12 month quit rate for the intervention groups compared to usual care and to each other. Analysis of qualitative data on process outcomes will be based on thematic analysis. Discussion High quality evidence on effectiveness of practice nurse interventions is needed to inform health policy on development of practice nurse roles. If effective

Efficiency of piezosurgery technique in miniscrew supported en-masse retraction: a single-centre, randomized controlled trial.

Science.gov (United States)

Tunçer, Nilüfer Irem; Arman-Özçirpici, Ayça; Oduncuoglu, Bahar Füsun; Göçmen, Jülide Sedef; Kantarci, Alpdogan

2017-11-30

Piezoelectric surgery is a newly introduced technique for rapid tooth movement. However, the efficiency of this technique has not been investigated on en-masse retraction cases yet. To investigate the efficiency of piezosurgery technique in accelerating miniscrew supported en-masse retraction and study the biological tissue response. In addition, to show if this technique induces a difference in dental, skeletal and soft tissue changes on lateral cephalograms, and in canine and molar rotations, besides intercanine and intermolar widths on dental casts. We conducted a randomized, single-centred, parallel-group, controlled trial, requiring upper right and left first premolar extractions on 30 patients above the minimum age of 14 years at the beginning of retraction. Piezosurgery-assisted versus conventional en-masse retraction anchored from miniscrews placed between second premolars and first molars, bilaterally. The main outcome was the en-masse retraction rate. Secondary outcomes were gingival crevicular fluid (GCF) volume and GCF content of receptor activator of nuclear factor κβ ligand (RANKL), changes regarding cephalometric and dental cast variables, and miniscrew success rates. Accomplished with opaque, sealed envelopes. Applicable for data assessment only. Commenced in February 2013 and ended in October 2014. Thirty-one patients were included in the study and divided into 2 groups of piezosurgery (n = 16) and control (n = 15). After 9.3 months of follow-up, no statistically significant difference was observed between groups for neither retraction rates (P = 0.958) nor GCF parameters (P > 0.05). Changes in lateral cephalometric and dental cast variables, and miniscrew success rates did not show significant differences either. Based on the results of this study, piezosurgery technique was found to be ineffective in accelerating en-masse retraction, and promoting a difference in the studied GCF parameters, skeletal and dental variables. The trial was not

A cluster randomised controlled trial of the Wellbeing in Secondary Education (WISE) Project - an intervention to improve the mental health support and training available to secondary school teachers: protocol for an integrated process evaluation.

Science.gov (United States)

Evans, Rhiannon; Brockman, Rowan; Grey, Jillian; Bell, Sarah; Harding, Sarah; Gunnell, David; Campbell, Rona; Murphy, Simon; Ford, Tamsin; Hollingworth, William; Tilling, Kate; Morris, Richard; Kadir, Bryar; Araya, Ricardo; Kidger, Judi

2018-05-04

Secondary school teachers have low levels of wellbeing and high levels of depression compared with the general population. Teachers are in a key position to support students, but poor mental health may be a barrier to doing so effectively. The Wellbeing in Secondary Education (WISE) project is a cluster randomised controlled trial (RCT) of an intervention to improve the mental health support and training available to secondary school teachers through delivery of the training package Mental Health First Aid and a staff peer support service. We will conduct a process evaluation as part of the WISE trial to support the interpretation of trial outcomes and refine intervention theory. The domains assessed will be: the extent to which the hypothesised mechanisms of change are activated; system level influences on these mechanisms; programme differentiation and usual practice; intervention implementation, including any adaptations; intervention acceptability; and intervention sustainability. Research questions will be addressed via quantitative and qualitative methods. All study schools (n = 25) will provide process evaluation data, with more detailed focus group, interview and observation data being collected from a subsample of case study schools (4 intervention and 4 control). Mechanisms of change, as outlined in a logic model, will be measured via teacher and student surveys and focus groups. School context will be explored via audits of school practice that relate to mental health and wellbeing, combined with stakeholder interviews and focus groups. Implementation of the training and peer support service will be assessed via training observations, training participant evaluation forms, focus groups with participants, interviews with trainers and peer support service users, and peer supporter logs recording help provided. Acceptability and sustainability will be examined via interviews with funders, head teachers, trainers and peer support services users, and

Remote monitoring field trial. Application to automated air sampling. Report on Task FIN-E935 of the Finnish Support Programme to IAEA Safeguards

International Nuclear Information System (INIS)

Poellaenen, R.; Ilander, T.; Lehtinen, J.; Leppaenen, A.; Nikkinen, M.; Toivonen, H.; Ylaetalo, S.; Smartt, H.; Garcia, R.; Martinez, R.; Glidewell, D.; Krantz, K.

1999-01-01

An automated air sampling station has recently been developed by Radiation and Nuclear Safety Authority (STUK). The station is furnished with equipment that allows comprehensive remote monitoring of the station and the data. Under the Finnish Support Programme to IAEA Safeguards, STUK and Sandia National Laboratories (SNL) established a field trial to demonstrate the use of remote monitoring technologies. STUK provided means for real-lime radiation monitoring and sample authentication whereas SNL delivered means for authenticated surveillance of the equipment and its location. The field trial showed that remote monitoring can be carried out using simple means although advanced facilities are needed for comprehensive surveillance. Authenticated measurement data could be reliably transferred from the monitoring site to the headquarters without the presence of authorized personnel in the monitoring site. The operation of the station and the remote monitoring system were reliable. (orig.)

Two-year outcomes of the Early Risers prevention trial with formerly homeless families residing in supportive housing.

Science.gov (United States)

Gewirtz, Abigail H; DeGarmo, David S; Lee, Susanne; Morrell, Nicole; August, Gerald

2015-04-01

This article reports 2-year outcomes from a cluster randomized, controlled trial of the Early Risers (ER) program implemented as a selective preventive intervention in supportive housing settings for homeless families. Based on the goals of this comprehensive prevention program, we predicted that intervention participants receiving ER services would show improvement in parenting and child outcomes relative to families in treatment-as-usual sites. The sample included 270 children in 161 families, residing in 15 supportive housing sites; multimethod, multi-informant assessments conducted at baseline and yearly thereafter included parent and teacher report of child adjustment, parent report of parenting self-efficacy, and parent-child observations that yielded scores of effective parenting practices. Data were modeled in HLM7 (4-level model accounting for nesting of children within families and families within housing sites). Two years' postbaseline, intent-to-treat (ITT) analyses indicated that parents in the ER group showed significantly improved parenting self-efficacy, and parent report indicated significant reductions in ER group children's depression. No main effects of ITT were shown for observed parenting effectiveness. However, over time, average levels of parenting self-efficacy predicted observed effective parenting practices, and observed effective parenting practices predicted improvements in both teacher- and parent-report of child adjustment. This is the first study to our knowledge to demonstrate prevention effects of a program for homeless families residing in family supportive housing. (c) 2015 APA, all rights reserved).

Findings of the Chronic Obstructive Pulmonary Disease-Sitting and Exacerbations Trial (COPD-SEAT) in Reducing Sedentary Time Using Wearable and Mobile Technologies With Educational Support: Randomized Controlled Feasibility Trial.

Science.gov (United States)

Orme, Mark W; Weedon, Amie E; Saukko, Paula M; Esliger, Dale W; Morgan, Mike D; Steiner, Michael C; Downey, John W; Sherar, Lauren B; Singh, Sally J

2018-04-11

vibration prompts from the waist-worn inclinometer (32.62%). Within 5 min of the prompt, 41% of responses occurred, with patients standing for a mean 1.4 (SD 0.8) min and walking for 0.4 (SD 0.3) min (21, SD 11, steps). Interviews indicated that being unwell and overwhelmed after an exacerbation was the main reason for not engaging with the intervention. Health care staff considered reducing sedentary behavior potentially attractive for patients but suggested starting the intervention as an inpatient. Although the data support that it was feasible to conduct the trial, modifications are needed to improve participant retention. The intervention was acceptable to most patients and health care professionals. International Standard Randomized Controlled Trial Number (ISRCTN) 13790881; http://www.isrctn.com/ISRCTN13790881 (Archived by WebCite at http://www.webcitation.org/6xmnRGjFf). ©Mark W Orme, Amie E Weedon, Paula M Saukko, Dale W Esliger, Mike D Morgan, Michael C Steiner, John W Downey, Lauren B Sherar, Sally J Singh. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 11.04.2018.

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

Directory of Open Access Journals (Sweden)

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

Study protocol: Improving patient choice in treating low back pain (IMPACT - LBP: A randomised controlled trial of a decision support package for use in physical therapy

Directory of Open Access Journals (Sweden)

Tysall Colin

2011-02-01

Full Text Available Abstract Background Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP, designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient. Methods/Design Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study. Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research. Discussion Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction. Trial registration Current Controlled Trials ISRCTN46035546

INSPIRE (INvestigating Social and PractIcal suppoRts at the End of life): Pilot randomised trial of a community social and practical support intervention for adults with life-limiting illness.

LENUS (Irish Health Repository)

McLoughlin, Kathleen

2015-11-24

For most people, home is the preferred place of care and death. Despite the development of specialist palliative care and primary care models of community based service delivery, people who are dying, and their families\\/carers, can experience isolation, feel excluded from social circles and distanced from their communities. Loneliness and social isolation can have a detrimental impact on both health and quality of life. Internationally, models of social and practical support at the end of life are gaining momentum as a result of the Compassionate Communities movement. These models have not yet been subjected to rigorous evaluation. The aims of the study described in this protocol are: (1) to evaluate the feasibility, acceptability and potential effectiveness of The Good Neighbour Partnership (GNP), a new volunteer-led model of social and practical care\\/support for community dwelling adults in Ireland who are living with advanced life-limiting illness; and (2) to pilot the method for a Phase III Randomised Controlled Trial (RCT).

The Effect of Participation in Support Groups on Depression, Anxiety and Stress in Family Caregivers of People with Alzheimers: Randomized clinical trial

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Fahimeh Taati

2016-07-01

Full Text Available This study sought to determine the effect of participation in support groups on the depression, anxiety and stress level of caregivers of patients with Alzheimer. This study was a single blind randomized clinical controlled trial (RCT with 80 family caregivers of people with Alzheimer’s (per group=40. The intervention group participated in eight sessions 1.5- 2 hours in support groups. The tool used in this study was the DASS-21 questionnaire for measuring depression, anxiety and stress level of the caregivers, analysis of parametric data, using SPSS version 21. Findings showed, participation in support groups showed no significant difference on depression, anxiety and stress in family caregivers of Alzheimer patients in the control group and the intervention group. Given that caring for these patients by their family members are very sensitive and costly issues for policy makers and health service providers, community and families of these patients.

Will the EU Clinical Trials Regulation Support the Innovative Industry in Bringing New Medicines Faster to Patients?

Science.gov (United States)

Atzor, Sabine; Gokhale, Surendra; Doherty, Michael

2013-04-01

A perspective from the innovative industry is provided in this article about the long awaited legal proposal for a Clinical Trial Regulation ("Proposal"), adopted in July 2012. With this Proposal, the European Commission reacted to a call by all stakeholders for more harmonization and streamlining of the provisions for conducting clinical trials in the EU. Discrepant approaches between Member States, a failure to respect legal timelines, and a lack of formal coordination mechanisms within and between Member States have resulted in an increased workload for the industry and contributed to a decline in Europe's attractiveness as a place to carry out research and development. The Proposal introduces a concept whereby the sponsor makes a single submission of the clinical trial application dossier to an EU portal, which is followed by a single assessment based on cooperation between Member States. A possibility for the sponsor to choose a 'reporting Member State' to take the lead on key aspects of the assessment is expected to support excellence building and work sharing of Competent Authorities in the EU. The Proposal respects the fact that certain aspects need to be reviewed nationally. The new process aims to lead to a single decision per clinical trial per concerned Member State. The rules are built on the principle of strict adherence to timelines for authorization. The timelines are ambitious but at the same time competitive, as the process builds in mechanisms that strengthen compliance. The rules have been designed to encourage sponsors to file complete submission packages, since any substantial modification to a trial would lead to delays in its commencement. Sponsors need to streamline their internal processes accordingly. In the end, streamlining is an effort that needs to be accepted by all parties involved. The Proposal does not detail how Member States organize the involvement of different bodies, such as Competent Authorities and Ethics Committees

Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

Science.gov (United States)

Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

2017-08-01

This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

Protocol for a cluster randomised controlled trial of an intervention to improve the mental health support and training available to secondary school teachers - the WISE (Wellbeing in Secondary Education) study.

Science.gov (United States)

Kidger, Judi; Evans, Rhiannon; Tilling, Kate; Hollingworth, William; Campbell, Rona; Ford, Tamsin; Murphy, Simon; Araya, Ricardo; Morris, Richard; Kadir, Bryar; Moure Fernandez, Aida; Bell, Sarah; Harding, Sarah; Brockman, Rowan; Grey, Jill; Gunnell, David

2016-10-18

Teachers are reported to be at increased risk of common mental health disorders compared to other occupations. Failure to support teachers adequately may lead to serious long-term mental disorders, poor performance at work (presenteeism), sickness absence and health-related exit from the profession. It also jeopardises student mental health, as distressed staff struggle to develop supportive relationships with students, and such relationships are protective against student depression. A number of school-based trials have attempted to improve student mental health, but these have mostly focused on classroom based approaches and have failed to establish effectiveness. Only a few studies have introduced training for teachers in supporting students, and none to date have included a focus on improving teacher mental health. This paper sets out the protocol (version 4.4 20/07/16) for a study aiming to address this gap. Cluster randomised controlled trial with secondary schools as the unit of randomisation. Intervention schools will receive: i) Mental Health First Aid (MHFA) training for a group of staff nominated by their colleagues, after which they will set up a confidential peer support service for colleagues ii) training in MHFA for schools and colleges for a further group of teachers, which will equip them to more effectively support student mental health iii) a short mental health awareness raising session and promotion of the peer support service for all teachers. Comparison schools will continue with usual practice. The primary outcome is teacher wellbeing measured using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcomes are teacher depression, absence and presenteeism, and student wellbeing, mental health difficulties, attendance and attainment. Measures will be taken at baseline, one year follow up (teachers only) and two year follow up. Economic and process evaluations will be embedded within the study. This study will establish the

Quality assurance of the SCOPE 1 trial in oesophageal radiotherapy.

Science.gov (United States)

Wills, Lucy; Maggs, Rhydian; Lewis, Geraint; Jones, Gareth; Nixon, Lisette; Staffurth, John; Crosby, Tom

2017-11-15

SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres. A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins. 36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm 3 ; and PTV volumes 221.9-513.3 cm 3 . For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark

A pilot cluster randomised controlled trial of a support and training intervention to improve the mental health of secondary school teachers and students – the WISE (Wellbeing in Secondary Education study

Directory of Open Access Journals (Sweden)

Judi Kidger

2016-10-01

Full Text Available Abstract Background Secondary school teachers are at heightened risk of psychological distress, which can lead to poor work performance, poor quality teacher-student relationships and mental illness. A pilot cluster randomised controlled trial (RCT – the WISE study – evaluated the feasibility of a full-scale RCT of an intervention to support school staff’s own mental health, and train them in supporting student mental health. Methods Six schools were randomised to an intervention or control group. In the intervention schools i 8–9 staff received Mental Health First Aid (MHFA training and became staff peer supporters, and ii youth MHFA training was offered to the wider staff body. Control schools continued with usual practice. We used thematic qualitative data analysis and regression modelling to ascertain the feasibility, acceptability and potential usefulness of the intervention. Results Thirteen training observations, 14 staff focus groups and 6 staff interviews were completed, and 438 staff (43.5 % and 1,862 (56.3 % students (years 8 and 9 completed questionnaires at baseline and one year later. MHFA training was considered relevant for schools, and trainees gained in knowledge, confidence in helping others, and awareness regarding their own mental health. Suggestions for reducing the length of the training and focusing on helping strategies were made. A peer support service was established in all intervention schools and was perceived to be helpful in supporting individuals in difficulty – for example through listening, and signposting to other services - and raising the profile of mental health at a whole school level. Barriers to use included lack of knowledge about the service, concerns about confidentiality and a preference for accessing support from pre-existing networks. Conclusions The WISE intervention is feasible and acceptable to schools. Results support the development of a full-scale cluster RCT, if steps are taken to

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

Science.gov (United States)

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 DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

DEFF Research Database (Denmark)

Krogh, Jesper; Saltin, Bengt; Gluud, Christian

2009-01-01

OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners or psych......: Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients, but they do support a beneficial effect of strength training on work capacity. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00103415.......OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners...... or psychiatrists and were eligible if they fulfilled the International Classification of Diseases, Tenth Revision, criteria for unipolar depression and were aged between 18 and 55 years. Patients (N = 165) were allocated to supervised strength, aerobic, or relaxation training during a 4-month period. The primary...

A Web-Based Tool to Support Shared Decision Making for People With a Psychotic Disorder: Randomized Controlled Trial and Process Evaluation

Science.gov (United States)

Emerencia, Ando C; Boonstra, Nynke; Wunderink, Lex; de Jonge, Peter; Sytema, Sjoerd

2013-01-01

Background Mental health policy makers encourage the development of electronic decision aids to increase patient participation in medical decision making. Evidence is needed to determine whether these decision aids are helpful in clinical practice and whether they lead to increased patient involvement and better outcomes. Objective This study reports the outcome of a randomized controlled trial and process evaluation of a Web-based intervention to facilitate shared decision making for people with psychotic disorders. Methods The study was carried out in a Dutch mental health institution. Patients were recruited from 2 outpatient teams for patients with psychosis (N=250). Patients in the intervention condition (n=124) were provided an account to access a Web-based information and decision tool aimed to support patients in acquiring an overview of their needs and appropriate treatment options provided by their mental health care organization. Patients were given the opportunity to use the Web-based tool either on their own (at their home computer or at a computer of the service) or with the support of an assistant. Patients in the control group received care as usual (n=126). Half of the patients in the sample were patients experiencing a first episode of psychosis; the other half were patients with a chronic psychosis. Primary outcome was patient-perceived involvement in medical decision making, measured with the Combined Outcome Measure for Risk Communication and Treatment Decision-making Effectiveness (COMRADE). Process evaluation consisted of questionnaire-based surveys, open interviews, and researcher observation. Results In all, 73 patients completed the follow-up measurement and were included in the final analysis (response rate 29.2%). More than one-third (48/124, 38.7%) of the patients who were provided access to the Web-based decision aid used it, and most used its full functionality. No differences were found between the intervention and control conditions

A blended psychosocial support program for partners of patients with amyotrophic lateral sclerosis and progressive muscular atrophy: protocol of a randomized controlled trial.

Science.gov (United States)

de Wit, Jessica; Beelen, Anita; Drossaert, Constance H C; Kolijn, Ruud; van den Berg, Leonard H; Visser-Meily, Johanna M A; Schröder, Carin D

2018-05-02

Informal caregivers of patients with Amyotrophic Lateral Sclerosis (ALS) or Progressive Muscular Atrophy (PMA) face stressful demands due to severe impairments and prospect of early death of the patients they care for. Caregivers often experience feelings of psychological distress and caregiver burden, but supportive interventions are lacking. The objective of this study is to investigate the effectiveness of a psychosocial support program aimed at enhancing feelings of control over caregiving tasks and reducing psychological distress. This support program is based on an existing program for adult partners of people with cancer and is adapted to meet the needs of ALS caregivers. This study is a randomized controlled trial using a wait-list control design. One hundred and forty caregiver-patient dyads, recruited from a nationwide database and through the website of the Dutch ALS Center, will be either randomized to a support program or a wait-list control group. The blended intervention is based on Acceptance and Commitment Therapy and consists of 1 face-to-face contact, 6 online guided modules and 1 telephone contact. The intervention can be worked through in 8 weeks. The effectiveness and the participants' satisfaction with the intervention will be evaluated using a mixed method design. Caregivers and patients will be asked to fill in questionnaires on 4 occasions during the study: baseline, 3 months, 6 months and 9 months. The main study outcome is the psychological distress of the caregiver assessed with the Hospital Anxiety and Depression Scale. Secondary outcomes are caregiver burden, caregiver quality of life, quality of life of the patient and psychological distress of the patient. Group differences in primary and secondary outcomes at 6 months will be compared with linear mixed model analysis. In a subgroup of caregivers we will explore experiences with the support program through semi-structured interviews. Usage of the online modules will be logged

Effectiveness of Personalized Feedback Alone or Combined with Peer Support to Improve Physical Activity in Sedentary Older Malays with Type 2 Diabetes: A Randomized Controlled Trial.

Science.gov (United States)

Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

2015-01-01

Regular physical activity is an important aspect of self-management among older people with type 2 diabetes but many remain inactive. Interventions to improve physical activity levels have been studied but few studies have evaluated the effects of personalized feedback (PF) or peer support (PS); and there was no study on older people of Asian heritage. Hence, this trial evaluated whether PF only or combined with PS improves physical activity among older Malays with type 2 diabetes (T2DM) compared to usual care only. A three-arm randomized controlled trial was conducted in a primary healthcare clinic in Malaysia. Sixty-nine sedentary Malays aged 60 years and older with T2DM who received usual diabetes care were randomized to PF or PS interventions or as controls for 12 weeks with follow-ups at weeks 24 and 36. Intervention groups performed unsupervised walking activity and received written feedback on physical activity. The PS group also received group and telephone contacts from trained peer mentors. The primary outcome was pedometer steps. Secondary outcomes were self-reported physical activity, cardiovascular risk factors, cardiorespiratory fitness, balance, quality of life, and psychosocial wellbeing. Fifty-two (75.4%) completed the 36-week study. The PS group showed greater daily pedometer readings than the PF and controls (p = 0.001). The PS group also had greater improvement in weekly duration (p fitness, and support from friends. Current Controlled Trials ISRCTN71447000.

Peer characteristics associated with improved glycemic control in a randomized controlled trial of a reciprocal peer support program for diabetes.

Science.gov (United States)

Kaselitz, Elizabeth; Shah, Megha; Choi, Hwajung; Heisler, Michele

2018-01-01

Objective In a secondary analysis of a randomized controlled trial of diabetes reciprocal peer support, we examined characteristics of peers associated with improvements in their partner's glycemic control. Methods A total of 102 adults with diabetes were randomized to the reciprocal peer support arm (vs. a nurse care management arm). The primary outcome was change in A1c over six months. Intermediate outcomes were insulin initiation and peer engagement. A number of baseline characteristics of peers were hypothesized to influence outcomes for their peer, and concordant characteristics of peer dyads were hypothesized that would influence outcomes for both peer partners. Results Improvement in A1c was associated with having a peer older than oneself ( P peers who reported poorer health at baseline had worse glycemic control at follow-up ( P peers had a more controlled self-regulation style were more likely to initiate insulin ( P peers whose partners were older and reported more diabetes distress at baseline supports the need for further research into the peer characteristics that lead to improved outcomes. This could allow for better matching and more effective partnerships.

Interventions in the workplace to support breastfeeding for women in employment.

Science.gov (United States)

Abdulwadud, Omar A; Snow, Mary Elizabeth

2012-10-17

In recent years there has been a rise in the participation rate of women in employment. Some may become pregnant while in employment and subsequently deliver their babies. Most may decide to return early to work after giving birth for various reasons. Unless these mothers get support from their employers and fellow employees, they might give up breastfeeding when they return to work. As a result, the duration and exclusivity of breastfeeding to the recommended age of the babies would be affected.Workplace environment can play a positive role to promote breastfeeding. For women going back to work, various types of workplace support interventions are available and this should not be ignored by employers. Notably, promoting breastfeeding in a workplace may have benefits for the women, the baby and also the employer. To assess the effectiveness of workplace interventions to support and promote breastfeeding among women returning to paid work after the birth of their children, and its impact on process outcomes pertinent to employees and employers. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (2 August 2012). Two authors independently assessed all identified studies for randomised controlled trials and quasi-randomised controlled trials that compared workplace interventions with no intervention or two or more workplace interventions against each other. Two authors planned to evaluate the methodological quality of the eligible trials and extract data. There were no randomised controlled trials or quasi-randomised controlled trials identified. No trials have evaluated the effectiveness of workplace interventions in promoting breastfeeding among women returning to paid work after the birth of their child. The impact of such intervention on process outcomes is also unknown. Randomised controlled trials are required to establish the benefits of various types of workplace interventions to support, encourage and promote breastfeeding among working

Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare.

Science.gov (United States)

Nyberg, André; Wadell, Karin; Lindgren, Helena; Tistad, Malin

2017-08-01

The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention, the COPD-web. METHODS AND ANALYSIS: The overall design is a pragmatic controlled pilot trial with preassessments and postassessments and a parallel process evaluation. Patients with the diagnosis of COPD will be eligible for the study. The intervention group will be recruited when visiting one of the six participating primary care units in Sweden. The control group will be identified from the unit's computerised registers. The intervention, the COPD-web, is an interactive web page with two sections; one directed at people with COPD and one at healthcare professionals. The sections aim to support patients' self-management skills-and to facilitate the provision of support for self-management strategies, respectively. Effectiveness with regard to patients' symptoms, HRQoL, knowledge of and readiness for COPD-related self-management, health literacy, self-efficacy for physical activity and time spent in physical activity and time being sedentary, and further, healthcare professionals' knowledge of and readiness to support COPD-related self-management strategies will be assessed using questionnaires at 3 and 12 months. The process evaluation will include observations and interviews. Ethical approval has been obtained. Findings will be presented at conferences, submitted for publication in peer-reviewed publications and presented to the involved healthcare professionals, patients and to patient organisations

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

OpenAIRE

Rushing, J.; Wing, R.; Wadden, T. A.; Knowler, W. C.; Lawlor, M.; Evans, M.; Killean, T.; Montez, M.; Espeland, M. A.; Zhang, P.

2017-01-01

Summary Objective The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10?years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. Methods The ...

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

Science.gov (United States)

Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

INSPIRE (INvestigating Social and PractIcal suppoRts at the End of life): Pilot randomised trial of a community social and practical support intervention for adults with life-limiting illness.

Science.gov (United States)

McLoughlin, Kathleen; Rhatigan, Jim; McGilloway, Sinead; Kellehear, Allan; Lucey, Michael; Twomey, Feargal; Conroy, Marian; Herrera-Molina, Emillio; Kumar, Suresh; Furlong, Mairead; Callinan, Joanne; Watson, Max; Currow, David; Bailey, Christopher

2015-11-24

For most people, home is the preferred place of care and death. Despite the development of specialist palliative care and primary care models of community based service delivery, people who are dying, and their families/carers, can experience isolation, feel excluded from social circles and distanced from their communities. Loneliness and social isolation can have a detrimental impact on both health and quality of life. Internationally, models of social and practical support at the end of life are gaining momentum as a result of the Compassionate Communities movement. These models have not yet been subjected to rigorous evaluation. The aims of the study described in this protocol are: (1) to evaluate the feasibility, acceptability and potential effectiveness of The Good Neighbour Partnership (GNP), a new volunteer-led model of social and practical care/support for community dwelling adults in Ireland who are living with advanced life-limiting illness; and (2) to pilot the method for a Phase III Randomised Controlled Trial (RCT). The INSPIRE study will be conducted within the Medical Research Council (MRC) Framework for the Evaluation of Complex Interventions (Phases 0-2) and includes an exploratory two-arm delayed intervention randomised controlled trial. Eighty patients and/or their carers will be randomly allocated to one of two groups: (I) Intervention: GNP in addition to standard care or (II) Control: Standard Care. Recipients of the GNP will be asked for their views on participating in both the study and the intervention. Quantitative and qualitative data will be gathered from both groups over eight weeks through face-to-face interviews which will be conducted before, during and after the intervention. The primary outcome is the effect of the intervention on social and practical need. Secondary outcomes are quality of life, loneliness, social support, social capital, unscheduled health service utilisation, caregiver burden, adverse impacts, and satisfaction

Performance of GUNGEN Idea Generation Support Groupware: Lessons from Over A Few Hundred Trial Sessions

Science.gov (United States)

Yuizono, Takaya; Munemori, Jun

GUNGEN-DXII, a new version of the GUNGEN groupware, allows the users to process hundreds of qualitative data segments (phrases and sentences) and compose a coherent piece of text containing a number of emergent ideas. The idea generation process is guided by the KJ method, a leading idea generation technique in Japan. This paper describes functions of GUNGEN supporting three major sub-activities of idea generation, namely, brainstorming, idea clustering, and text composition, and also summarizes the results obtained from a few hundred trial sessions with the old and new GUNGEN systems in terms of some qualitative and quantitative measures. The results show that the sessions with GUNGEN yield intermediate and final products at least as good as those from the original paper-and-pencil KJ method sessions, in addition to the advantages of the online system, such as distance collaboration and digital storage of the products. Moreover, results from the new GUNGEN-DXII raises hope for enabling the users to handle an extremely large number of qualitative data segments in the near future.

Vitex-agnus-castus-Extrakt (Ze 440 zur Symptombehandlung bei Frauen mit menstruellen Zyklusstörungen

Directory of Open Access Journals (Sweden)

Eltbogen R

2015-01-01

Full Text Available Ziel: Diese nichtinterventionelle Beobachtungsstudie (NIS wurde von Schweizer Gynäkologen und Allgemeinmedizinern im Rahmen der üblichen ärztlichen Grundversorgung durchgeführt. Das Ziel der NIS war es, die Wirksamkeit und Sicherheit von Vitex-agnus-castus-(VAC Extrakt (Ze 440: premens, Zeller Medical AG, Romanshorn, Schweiz bei Frauen, die unter menstruellen Zyklusstörungen wie Polymenorrhö, Oligomenorrhö oder Amenorrhö litten, zu untersuchen. Methode: Insgesamt 211 Patientinnen nahmen an dieser NIS teil. Symptome, die mit menstruellen Zyklusstörungen („menstrual cycle irregularities“ [MCIs] und der Menstruationsblutung in Verbindung stehen, wurden bei einer Erstuntersuchung („baseline visit“ [BV] und einer Kontrolluntersuchung („follow-up visit“ [FV] nach Behandlung mit VAC-Extrakt über einen Zeitraum von 3 aufeinanderfolgenden Menstruationszyklen beurteilt. Ergebnisse: Der Anteil der Patientinnen, bei denen eine Beschwerdefreiheit oder eine Besserung der MCIs (insgesamt und spezifischer Beschwerdebilder wie Polymenorrhö, Oligomenorrhö und Amenorrhö erzielt werden konnte, lag bei der FV bei 79–85 %. Bei Symptomen im Zusammenhang mit der Menstruationsblutung wie Dysmenorrhö, Zwischenblutungen, Hypermenorrhö, Menometrorrhagie, Ovulationsblutung, präoder postmenstrueller Blutung betrug der Anteil der Patientinnen, bei denen ein Rückgang oder eine Besserung festgestellt wurde, bei der FV zwischen 60 und 88 %. Von 53 Patientinnen, die bei der BV von einem unerfüllten Kinderwunsch berichteten, wurden 12 Frauen (23 % während der Behandlung mit VAC-Extrakt schwanger. Bei der FV waren 91 % der Ärzte und 92 % der Patientinnen mit den erzielten Behandlungsergebnissen „zufrieden“ oder „sehr zufrieden“ und 80 % der Patientinnen bestätigten, dass sie gerne mit der Behandlung mit VAC-Extrakt fortfahren wollen. Fazit: Diese Beobachtungsstudie im Bereich der ärztlichen Grundversorgung ergab, dass die Behandlung mit VAC

Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial.

Science.gov (United States)

Gega, Lina; Swift, Louise; Barton, Garry; Todd, Gillian; Reeve, Nesta; Bird, Kelly; Holland, Richard; Howe, Amanda; Wilson, Jon; Molle, Jo

2012-08-27

Computerised cognitive behaviour therapy (cCBT) involves standardised, automated, interactive self-help programmes delivered via a computer. Randomised controlled trials (RCTs) and observational studies have shown than cCBT reduces depressive symptoms as much as face-to-face therapy and more than waiting lists or treatment as usual. cCBT's efficacy and acceptability may be influenced by the "human" support offered as an adjunct to it, which can vary in duration and can be offered by people with different levels of training and expertise. This is a two-by-two factorial RCT investigating the effectiveness, cost-effectiveness and acceptability of cCBT supplemented with 12 weekly phone support sessions are either brief (5-10 min) or extended (20-30 min) and are offered by either an expert clinician or an assistant with no clinical training. Adults with non-suicidal depression in primary care can self-refer into the study by completing and posting to the research team a standardised questionnaire. Following an assessment interview, eligible referrals have access to an 8-session cCBT programme called Beating the Blues and are randomised to one of four types of support: brief-assistant, extended-assistant, brief-clinician or extended-clinician.A sample size of 35 per group (total 140) is sufficient to detect a moderate effect size with 90% power on our primary outcome measure (Work and Social Adjustment Scale); assuming a 30% attrition rate, 200 patients will be randomised. Secondary outcome measures include the Beck Depression and Anxiety Inventories and the PHQ-9 and GAD-7. Data on clinical outcomes, treatment usage and patient experiences are collected in three ways: by post via self-report questionnaires at week 0 (randomisation) and at weeks 12 and 24 post-randomisation; electronically by the cCBT system every time patients log-in; by phone during assessments, support sessions and exit interviews. The study's factorial design increases its efficiency by allowing the

Effect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial.

Science.gov (United States)

Davis, Lori L; Kyriakides, Tassos C; Suris, Alina M; Ottomanelli, Lisa A; Mueller, Lisa; Parker, Pamela E; Resnick, Sandra G; Toscano, Richard; Scrymgeour, Alexandra A; Drake, Robert E

2018-04-01

Posttraumatic stress disorder (PTSD) often interferes with a person's ability to obtain or sustain employment, which leads to premature exit from the labor force and reduced income. To determine whether individual placement and support (IPS)-supported employment is more effective than stepwise vocational rehabilitation involving transitional work assignments at helping veterans with PTSD attain steady, competitive employment. The Veterans Individual Placement and Support Toward Advancing Recovery (VIP-STAR) study was a prospective, multisite, randomized clinical trial that included 541 unemployed veterans with PTSD at 12 Veterans Affairs medical centers. Data were collected from December 23, 2013, to May 3, 2017. Intent-to-treat analysis was performed. Individual placement and support is a supported employment intervention that rapidly engages people with disabilities in community job development to obtain work based on their individual job preferences. Transitional work is a stepwise vocational rehabilitation intervention that assigns people temporarily to noncompetitive jobs as preparation for competitive employment in the community. A priori hypotheses were that, compared with those in transitional work, more participants in the IPS group would become steady workers (primary) and earn more income from competitive jobs (secondary) over 18 months. Steady worker was defined as holding a competitive job for at least 50% of the 18-month follow-up period. A total of 541 participants (n = 271 IPS; n = 270 transitional work) were randomized. Mean (SD) age was 42.2 (11) years; 99 (18.3%) were women, 274 (50.6%) were white, 225 (41.6%) were African American, and 90 (16.6%) were of Hispanic, Spanish, or Latino ethnicity. More participants in the IPS group achieved steady employment than in the transitional work group (105 [38.7%] vs 63 [23.3%]; odds ratio, 2.14; 95% CI, 1.46-3.14). A higher proportion of IPS participants attained any competitive job (186 [68.6%] vs

Effects of automated smartphone mobile recovery support and telephone continuing care in the treatment of alcohol use disorder: study protocol for a randomized controlled trial.

Science.gov (United States)

McKay, James R; Gustafson, David H; Ivey, Megan; McTavish, Fiona; Pe-Romashko, Klaren; Curtis, Brenda; Oslin, David A; Polsky, Daniel; Quanbeck, Andrew; Lynch, Kevin G

2018-01-30

New smartphone communication technology provides a novel way to provide personalized continuing care support following alcohol treatment. One such system is the Addiction version of the Comprehensive Health Enhancement Support System (A-CHESS), which provides a range of automated functions that support patients. A-CHESS improved drinking outcomes over standard continuing care when provided to patients leaving inpatient treatment. Effective continuing care can also be delivered via telephone calls with a counselor. Telephone Monitoring and Counseling (TMC) has demonstrated efficacy in two randomized trials with alcohol-dependent patients. A-CHESS and TMC have complementary strengths. A-CHESS provides automated 24/7 recovery support services and frequent assessment of symptoms and status, but does not involve regular contact with a counselor. TMC provides regular and sustained contact with the same counselor, but no ongoing support between calls. The future of continuing care for alcohol use disorders is likely to involve automated mobile technology and counselor contact, but little is known about how best to integrate these services. To address this question, the study will feature a 2 × 2 design (A-CHESS for 12 months [yes/no] × TMC for 12 months [yes/no]), in which 280 alcohol-dependent patients in intensive outpatient programs (IOPs) will be randomized to one of the four conditions and followed for 18 months. We will determine whether adding TMC to A-CHESS produces fewer heavy drinking days than TMC or A-CHESS alone and test for TMC and A-CHESS main effects. We will determine the costs of each of the four conditions and the incremental cost-effectiveness of the three active conditions. Analyses will also examine secondary outcomes, including a biological measure of alcohol use, and hypothesized moderation and mediation effects. The results of the study will yield important information on improving patient alcohol use outcomes by integrating mobile

Health providers' perceptions of clinical trials : lessons from Ghana, Kenya and Burkina Faso

NARCIS (Netherlands)

Angwenyi, Vibian; Asante, Kwaku-Poku; Traoré, Abdoulaye; Febir, Lawrence Gyabaa; Tawiah, Charlotte; Kwarteng, Anthony; Ouédraogo, Alphonse; Sirima, Sodiomon Bienvenue; Owusu-Agyei, Seth; Imoukhuede, Egeruan Babatunde; Webster, Jayne; Chandramohan, Daniel; Molyneux, Sassy; Jones, Caroline

2015-01-01

BACKGROUND: Clinical trials conducted in Africa often require substantial investments to support trial centres and public health facilities. Trial resources could potentially generate benefits for routine health service delivery but may have unintended consequences. Strengthening ethical practice

Design of a multicentre randomized controlled trial to evaluate the effectiveness of a tailored clinical support intervention to enhance return to work for gastrointestinal cancer patients.

Science.gov (United States)

Zaman, AnneClaire G N M; Tytgat, Kristien M A J; Klinkenbijl, Jean H G; Frings-Dresen, Monique H W; de Boer, Angela G E M

2016-05-10

Gastrointestinal (GI) cancer is frequently diagnosed in people of working age, and many GI cancer patients experience work-related problems. Although these patients often experience difficulties returning to work, supportive work-related interventions are lacking. We have therefore developed a tailored work-related support intervention for GI cancer patients, and we aim to evaluate its cost-effectiveness compared with the usual care provided. If this intervention proves effective, it can be implemented in practice to support GI cancer patients after diagnosis and to help them return to work. We designed a multicentre randomized controlled trial with a follow-up of twelve months. The study population (N = 310) will include individuals aged 18-63 years diagnosed with a primary GI cancer and employed at the time of diagnosis. The participants will be randomized to the intervention or to usual care. 'Usual care' is defined as psychosocial care in which work-related issues are not discussed. The intervention group will receive tailored work-related support consisting of three face-to-face meetings of approximately 30 min each. Based on the severity of their work-related problems, the intervention group will be divided into groups receiving three types of support (A, B or C). A different supportive healthcare professional will be available for each group: an oncological nurse (A), an oncological occupational physician (B) and a multidisciplinary team (C) that includes an oncological nurse, oncological occupational physician and treating oncologist/physician. The primary outcome measure is return to work (RTW), defined as the time to a partial or full RTW. The secondary outcomes are work ability, work limitations, quality of life, and direct and indirect costs. The hypothesis is that tailored work-related support for GI cancer patients is more effective than usual care in terms of the RTW. The intervention is innovative in that it combines oncological and

Psychological Treatment Trials for Hypoactive Sexual Desire Disorder: A Sexual Medicine Critique and Perspective.

Science.gov (United States)

Pyke, Robert E; Clayton, Anita H

2015-12-01

Publications claim efficacy for treatment of hypoactive sexual desire disorder (HSDD) in women with cognitive behavior therapy (CBT) and mindfulness meditation training (MMT). However, no review has evaluated the evidence for these therapies from the rigorous perspective of sexual medicine. The aim of this study was to evaluate the published controlled trials of CBT and MMT for disorders of sexual desire from the perspective of sexual medicine standards of control paradigms, risk/benefit ratios, and clinical significance. MEDLINE was reviewed from the last 10 years. Evaluated study quality via 10 metrics and efficacy as mean change, and proportion of responders and remitters. Three controlled trials support CBT and two controlled trials support MMT. The reports of the trials each lacked several scientific requirements: a hierarchy of endpoints with a planned primary endpoint, sufficient information on the intervention to reproduce it, randomization, adequate control, accepted measures of benefits and harms, compliance data, and/or outcomes of clinical relevance. Psychological treatments for HSDD are not yet supported by adequate clinical trials. The current scientific and regulatory standards for drug treatment trials should also be applicable to psychological treatment trials. © 2015 International Society for Sexual Medicine.

Exploring assistive technology use to support cognition in college students with histories of mild traumatic brain injury.

Science.gov (United States)

Brown, Jessica; Wollersheim, Madeline

2018-01-19

College students with mild traumatic brain injury (mTBI) may experience chronic cognitive deficits necessitating use of external supports for daily task completion. The purpose of this study was to explore cognitive support system selection and use by students with histories of mTBI when completing novel prospective memory tasks. We implemented a multiple case study, sequential explanatory mixed-methods design with three participants. Participants completed four experimental phases: (1) background history collection, cognitive assessment completion, pre-trial interview, and selection of two external supports for trial phase use; (2) trial Phase 1 (i.e., 10-days); (3) trial Phase 2 (i.e., 10 days); and (4) post-trial exit interview. We examined participants' support type and characteristic preferences and evaluated task execution accuracy when implementing differing supports. Participants expressed both collective and unique cognitive aid preferences before trial completion. Trial phase results revealed that task completion accuracy did not alter substantially between trials; however, personal preferences and perceived usefulness of trialled cognitive aid systems appeared to impact support implementation and effectiveness. Themes emerged from post-trial interview relating to the (a) necessity for differing functions of individual systems and (b) importance of trialling devices prior to selection. Results emphasize the necessity of person-centred approaches to treatment due to the variability of performance accuracy and system preferences. The cognitive aid selection and implementation intervention protocol piloted in this study appears beneficial for understanding unique strengths and challenges for college students following mTBI and may be useful for clinicians working with individuals with mTBI. Implications for rehabilitation College-aged students with mild traumatic brain injury report unique preferences for no- and high-tech cognitive aids; however, similar

Economic analysis of the TAX 317 trial: docetaxel versus best supportive care as second-line therapy of advanced non-small-cell lung cancer.

Science.gov (United States)

Leighl, Natasha B; Shepherd, Frances A; Kwong, Rita; Burkes, Ronald L; Feld, Ronald; Goodwin, Pamela J

2002-03-01

To determine the cost-effectiveness (CE) of second-line docetaxel compared with best supportive care (BSC) in the TAX 317 trial, a randomized clinical trial of second-line chemotherapy in non-small-cell lung cancer. A retrospective CE analysis of the TAX 317 trial was undertaken, evaluating direct medical costs of therapy from the viewpoint of Canada's public health care system. Costs were derived in 1999 Canadian dollars, and resource use was determined through prospective trial data. The incremental survival benefit in the docetaxel arm over BSC was 2 months (P =.047). The CE of docetaxel was $57,749 per year of life gained. For patients treated with docetaxel 75 mg/m(2), the CE was $31,776 per year of life gained. In univariate sensitivity analyses, CE estimates were most sensitive to changes in survival, ranging from $18,374 to $117,434 with 20% variation in survival at the recommended dose. The largest cost center in both arms was hospitalization, followed by the cost of drugs, investigations, radiotherapy, and community care. BSC patients had fewer hospitalizations than patients in the chemotherapy arm and were more often palliated at home. Although the decision to treat should not be based on economic considerations alone, our CE estimate of $31,776 per year of life gained (at the currently recommended dose of docetaxel) is within an acceptable range of health care expenditures, and the total costs of therapy are similar to those of second-line palliative chemotherapy for other solid tumors.

Quality Assurance for Clinical Trials

Science.gov (United States)

Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

2013-01-01

Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches.

Science.gov (United States)

Elliott, Daisy; Husbands, Samantha; Hamdy, Freddie C; Holmberg, Lars; Donovan, Jenny L

2017-11-01

The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improve-recruitment and informed consent within a range of clinical trials. A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups

Kyphoplasty and vertebroplasty for spinal trauma; Kyphoplastie und Vertebroplastie bei Wirbelsaeulentraumata

Energy Technology Data Exchange (ETDEWEB)

Ahlhelm, F. [Kantonsspital Baden AG, Abteilung fuer Neuroradiologie, Institut fuer Radiologie, Baden (Switzerland); Omidi, R. [Kantonsspital Baden AG, Interventionelle Radiologie, Institut fuer Radiologie, Baden (Switzerland)

2016-08-15

Minimally invasive treatment of spinal fractures. Conservative treatment versus spinal surgery. Minimally invasive stabilization techniques, such as percutaneous (assisted) cementoplasty have been introduced as new procedures. Magnetic resonance imaging (MRI), X-rays and computed tomography (CT) are the imaging techniques of first choice. The most important questions concern recent fractures, instability and indications for minimally invasive treatment. Vertebroplasty and kyphoplasty are established methods for the treatment of patients with osteoporosis. Cementoplasty techniques are promising treatment options for traumatic spinal injuries. The application of the techniques should best be carried out in individual cases within the framework of prospective controlled studies. (orig.) [German] Minimal-invasive Behandlung von Wirbelsaeulentraumata. Konservative Behandlung vs. Wirbelsaeulenchirurgie. Als neue Verfahren wurden minimal-invasive Stabilisationstechniken, z. B. perkutane (assistierte) Zementoplastien eingefuehrt. Roentgen, MRT und CT sind die bildgebenden Verfahren der ersten Wahl. Die wichtigsten Fragestellungen sind: Frische Fraktur? Instabilitaet? Indikation fuer minimal-invasive Behandlung ?Vertebroplastie und Kyphoplastie sind bei Osteoporosepatienten etabliert. Bei Wirbelsaeulentraumata sind Zementoplastietechniken vielversprechende Therapieoptionen. Die Anwendung der Techniken sollte im individuellen Fall am besten im Rahmen prospektiver kontrollierter Studien erfolgen. (orig.)

A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial.

Science.gov (United States)

Adolfsson, Annsofie; Linden, Karolina; Sparud-Lundin, Carina; Larsson, Per-Göran; Berg, Marie

2014-12-29

Women with type 1 diabetes face particular demands in their lives in relation to childbearing. During pregnancy, in order to optimize the probability of giving birth to a healthy child, their blood glucose levels need to be as normal as possible. After childbirth, they experience a 'double stress': in addition to the ordinary challenges they face as new mothers, they also need to focus on getting their blood glucose levels normal. To improve self-management of diabetes and overall well-being in women with type 1 diabetes, a person-centered web-based support was designed to be tested in a randomized controlled trial (RCT) to be used during pregnancy and early motherhood. This protocol outlines the design of this RCT, which will evaluate the effectiveness of the specially designed web-based support for mothers with type 1 diabetes in Sweden. The study is designed as an RCT. The web support consists of three parts: 1) evidence-based information, 2) a self-care diary, and 3) communication with peers. The primary outcome is general well-being evaluated with the Well-Being Questionnaire short version (W-BQ12) and diabetes management evaluated with the Diabetes Empowerment Scale, short version (SWE-DES). Women attending six hospital-based antenatal care centers in Sweden are invited to participate. The inclusion period is November 2011 to late 2014. The allocation of participants to web support (intervention group) and to usual care (control group) is equal (1:1). In total, 68 participants in each group will be needed to reach a statistical power of 80% with significance level 0.05. The web support is expected to strengthen the women's personal capacity and autonomy during pregnancy, breastfeeding, and early motherhood, leading to optimal well-being and diabetes management. ClinicalTrials.gov: NCT01565824 (registration date March 27th 2012).

Effect of Supportive Nursing Care on Self Esteem of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

Science.gov (United States)

Ebrahimi, Hossein; Navidian, Ali; Keykha, Roghaieh

2014-01-01

Introduction: Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. Methods: This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35) and intervention (n=35) groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES). Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ2, t-test and ANCOVA. Results: Results showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention. Conclusion: The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients. PMID:25276758

Effect of supportive nursing care on self esteem of patients receiving electroconvulsive therapy: a randomized controlled clinical trial.

Science.gov (United States)

Ebrahimi, Hossein; Navidian, Ali; Keykha, Roghaieh

2014-06-01

Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35) and intervention (n=35) groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES). Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ(2), t-test and ANCOVA. RESULTS showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention. The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients.

Effect of Supportive Nursing Care on Self Esteem of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

Directory of Open Access Journals (Sweden)

Hossein Ebrahimi

2014-06-01

Full Text Available Introduction: Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. Methods: This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35 and intervention (n=35 groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES. Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ2, t-test and ANCOVA. Results: Results showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention.Conclusion: The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients.

Therapist-supported Internet cognitive behavioural therapy for anxiety disorders in adults.

Science.gov (United States)

Olthuis, Janine V; Watt, Margo C; Bailey, Kristen; Hayden, Jill A; Stewart, Sherry H

2016-03-12

Cognitive behavioural therapy (CBT) is an evidence-based treatment for anxiety disorders. Many people have difficulty accessing treatment, due to a variety of obstacles. Researchers have therefore explored the possibility of using the Internet to deliver CBT; it is important to ensure the decision to promote such treatment is grounded in high quality evidence. To assess the effects of therapist-supported Internet CBT (ICBT) on remission of anxiety disorder diagnosis and reduction of anxiety symptoms in adults as compared to waiting list control, unguided CBT, or face-to-face CBT. Effects of treatment on quality of life and patient satisfaction with the intervention were also assessed. We searched the Cochrane Depression, Anxiety and Neurosis Review Group Specialised Register (CCDANCTR) to 16 March 2015. The CCDANCTR includes relevant randomised controlled trials from MEDLINE, EMBASE, PsycINFO and CENTRAL. We also searched online clinical trial registries and reference lists of included studies. We contacted authors to locate additional trials. Each identified study was independently assessed for inclusion by two authors. To be included, studies had to be randomised controlled trials of therapist-supported ICBT compared to a waiting list, attention, information, or online discussion group; unguided CBT (that is, self-help); or face-to-face CBT. We included studies that treated adults with an anxiety disorder (panic disorder, agoraphobia, social phobia, post-traumatic stress disorder, acute stress disorder, generalized anxiety disorder, obsessive compulsive disorder, and specific phobia) defined according to the Diagnostic and Statistical Manual of Mental Disorders III, III-R, IV, IV-TR or the International Classification of Disesases 9 or 10. Two authors independently assessed the risk of bias of included studies and judged overall study quality. We used data from intention-to-treat analyses wherever possible. We assessed treatment effect for the dichotomous outcome

The exploitation of "Exploitation" in the tenofovir prep trial in Cameroon: Lessons learned from media coverage of an HIV prevention trial.

Science.gov (United States)

Mack, Natasha; Robinson, Elizabeth T; MacQueen, Kathleen M; Moffett, Jill; Johnson, Laura M

2010-06-01

media coverage influences how clinical trials are perceived internationally and in communities where trials occur, affecting recruitment, retention, and political support for research. We conducted a discourse analysis of news coverage from 2004-2005 of a trial in Cameroon on oral PrEP for HIV prevention, to identify messages, communication techniques, and sources of messages that were amplified via media. We identified two parallel discourses: one on ethical concerns about the Cameroon trial, and a second, more general "science exploitation" discourse concerned with the potential for trials with vulnerable participant populations to be conducted unethically, benefiting only wealthy populations. Researchers should overtly address exploitation as an integral, ongoing component of research, particularly where historical or cultural conditions set the stage for controversy to emerge.

Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial.

Science.gov (United States)

Fischer, Henry H; Fischer, Ilana P; Pereira, Rocio I; Furniss, Anna L; Rozwadowski, Jeanne M; Moore, Susan L; Durfee, Michael J; Raghunath, Silvia G; Tsai, Adam G; Havranek, Edward P

2016-08-01

Although the benefits of in-person Diabetes Prevention Program (DPP) classes for diabetes prevention have been demonstrated in trials, effectiveness in clinical practice is limited by low participation rates. This study explores whether text message support enhances weight loss in patients offered DPP classes. English- and Spanish-speaking patients with prediabetes (n = 163) were randomized to the control group, which only received an invitation to DPP classes as defined by the Centers for Disease Control and Prevention, or to the text message-augmented intervention group, which also received text messages adapted from the DPP curriculum for 12 months. Mean weight decreased 0.6 pounds (95% CI -2.7 to 1.6) in the control group and 2.6 pounds (95% CI -5.5 to 0.2) in the intervention group (P value 0.05). Three percent weight loss was achieved by 21.5% of participants in the control group (95% CI 12.5-30.6), compared with 38.5% in the intervention group (95% CI 27.7-49.3) (absolute difference 17.0%; P value 0.02). Mean glycated hemoglobin (HbA1c) increased by 0.19% or 2.1 mmol/mol (95% CI -0.1 to 0.5%) and decreased by 0.09% or 1.0 mmol/mol (95% CI -0.2 to 0.0%) in the control group and intervention participants, respectively (absolute difference 0.28%; P value 0.07). Stratification by language demonstrated a significant treatment effect in Spanish speakers but not in English speakers. Text message support can lead to clinically significant weight loss in patients with prediabetes. Further study assessing effect by primary language and in an operational setting is warranted. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Gemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results of the Randomized Phase III EORTC-GIMEMA AML-19 Trial

NARCIS (Netherlands)

Amadori, S.; Suciu, S.; Selleslag, D.; Aversa, F.; Gaidano, G.; Musso, M.; Annino, L.; Venditti, A.; Voso, M.T.; Mazzone, C.; Magro, D.; Fabritiis, P. De; Muus, P.; Alimena, G.; Mancini, M.; Hagemeijer, A.; Paoloni, F.; Vignetti, M.; Fazi, P.; Meert, L.; Ramadan, S.M.; Willemze, R.; Witte, T.J. de; Baron, F.

2016-01-01

PURPOSE: To compare single-agent gemtuzumab ozogamicin (GO) with best supportive care (BSC) including hydroxyurea as first-line therapy in older patients with acute myeloid leukemia unsuitable for intensive chemotherapy. PATIENTS AND METHODS: In this trial, patients at least 61 years old were

NCI-supported facility to conduct cancer trials breaks ground in Puerto Rico

Science.gov (United States)

The Puerto Rican government has allocated $196 million dollars to build a 287,000 sq. ft., 96-bed, cancer hospital in San Juan. The new hospital, which will provide cancer treatment and conduct clinical trials, is the first of its kind in the Caribbean.

Development and Implementation of an Interactive Text Messaging Campaign to Support Behavior Change in a Childhood Obesity Randomized Controlled Trial.

Science.gov (United States)

Price, Sarah; Ferisin, Stephanie; Sharifi, Mona; Steinberg, David; Bennett, Gary; Wolin, Kathleen Y; Horan, Christine; Koziol, Renata; Marshall, Richard; Taveras, Elsie M

2015-01-01

Text messaging is a promising means of intervening on an array of health issues among varied populations, but little has been published about the development of such interventions. The authors describe the development and implementation of an interactive text messaging campaign for parents to support behavior change among children in a childhood obesity randomized controlled trial. The authors invited 160 parents to participate in a text messaging intervention that provided behavior change support in conjunction with health coaching phone calls and mailed materials on behavioral goals. Throughout the 1-year intervention, the authors sent 1-2 text messages per week. The first asked how the child did with a target behavior the day before; parents who replied received an immediate feedback message tailored to their response. The second included a tip about how to work toward a behavioral goal. Baseline surveys indicate that text messaging is a common means of communication for parents, and many are willing to use text messaging to support behavior change for their child. Results at 1 year indicate a high level of engagement with the text messaging intervention, with nearly two thirds responding to 75% or more of the questions they were sent by text.

Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

DEFF Research Database (Denmark)

Punthakee, Z; Bosch, J; Dagenais, G

2012-01-01

AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...

Supportive interventions for enhancing dietary intake in malnourished or nutritionally at-risk adults.

Science.gov (United States)

Baldwin, Christine; Kimber, Katherine L; Gibbs, Michelle; Weekes, Christine Elizabeth

2016-12-20

Supportive interventions such as serving meals in a dining room environment or the use of assistants to feed patients are frequently recommended for the management of nutritionally vulnerable groups. Such interventions are included in many policy and guideline documents and have implications for staff time but may incur additional costs, yet there appears to be a lack of evidence for their efficacy. To assess the effects of supportive interventions for enhancing dietary intake in malnourished or nutritionally at-risk adults. We identified publications from comprehensive searches of the Cochrane Library, MEDLINE, Embase, AMED, British Nursing Index, CINAHL, SCOPUS, ISI Web of Science databases, scrutiny of the reference lists of included trials and related systematic reviews and handsearching the abstracts of relevant meetings. The date of the last search for all databases was 31 March 2013. Additional searches of CENTRAL, MEDLINE, ClinicalTrials.gov and WHO ICTRP were undertaken to September 2016. The date of the last search for these databases was 14 September 2016. Randomised controlled trials of supportive interventions given with the aim of enhancing dietary intake in nutritionally vulnerable adults compared with usual care. Three review authors and for the final search, the editor, selected trials from titles and abstracts and independently assessed eligibility of selected trials. Two review authors independently extracted data and assessed risk of bias, as well as evaluating overall quality of the evidence utilising the GRADE instrument, and then agreed as they entered data into the review. The likelihood of clinical heterogeneity amongst trials was judged to be high as trials were in populations with widely different clinical backgrounds, conducted in different healthcare settings and despite some grouping of similar interventions, involved interventions that varied considerably. We were only able, therefore, to conduct meta-analyses for the outcome measures

Supporting the improvement and management of prescribing for urinary tract infections (SIMPle): protocol for a cluster randomized trial

Science.gov (United States)

2013-01-01

Background The overuse of antimicrobials is recognized as the main selective pressure driving the emergence and spread of antimicrobial resistance in human bacterial pathogens. Urinary tract infections (UTIs) are among the most common infections presented in primary care and empirical antimicrobial treatment is currently recommended. Previous research has identified that a substantial proportion of Irish general practitioners (GPs) prescribe antimicrobials for UTIs that are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland. The aim of this trial is to design, implement and evaluate the effectiveness of a complex intervention on GP antimicrobial prescribing and adult (18 years of age and over) patients’ antimicrobial consumption when presenting with a suspected UTI. Methods/design The Supporting the Improvement and Management of Prescribing for urinary tract infections (SIMPle) study is a three-armed intervention with practice-level randomization. Adult patients presenting with suspected UTIs in primary care will be included in the study. The intervention integrates components for both GPs and patients. For GPs the intervention includes interactive workshops, audit and feedback reports and automated electronic prompts summarizing recommended first-line antimicrobial treatment and, for one intervention arm, a recommendation to consider delayed antimicrobial treatment. For patients, multimedia applications and information leaflets are included. Thirty practices will be recruited to the study; laboratory data indicate that 2,038 patients will be prescribed an antimicrobial in the study. The primary outcome is a change in prescribing of first-line antimicrobials for UTIs in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland. The study will take place over 15 months with a six-month intervention period. Data will be collected through a remote electronic anonymized data-extraction system

Therapy of canine corneal pannus with strontium-90; Die Behandlung der Keratitis superficialis chronica des Hundes mit Strontium-90

Energy Technology Data Exchange (ETDEWEB)

Hoecht, S.; Nausner, M.; Hinkelbein, W. [Universitaetsklinikum Benjamin Franklin, Berlin (Germany). Klinik und Poliklinik fuer Radioonkologie und Strahlentherapie; Gruening, G.; Allgoewer, I.; Brunnberg, L. [Freie Univ. Berlin (Germany). Klinik und Poliklinik fuer Kleine Haustiere

2002-02-01

immer wieder propagiert. Ziel der Untersuchung war es, Wirksamkeit und Nebenwirkungen dieser Therapie zu dokumentieren. Material und Methoden: Behandelt wurden 17 Tiere. Bei 13 erfolgte neben einer medikamentoesen Behandlung mit Ciclosporin und Prednisolon eine Bestrahlung mit 2 x 15 Gy Oberflaechendosis mit einem Sr-90-Augenapplikator innerhalb von 2 Tagen. Behandelt wurde jeweils das schwerer erkrankte Auge, das andere Auge diente als Kontrolle. Bei vier weiteren Tieren mit initial bereits erheblicher Visuseinschraenkung erfolgte zusaetzlich eine Keratektomie, beide Augen wurden anschliessend bestrahlt. Ergebnisse: Bei fast allen Tieren (11/13; 85%) zeigte sich an den nur medikamentoes behandelten Augen eine Verschlechterung der Ausdehnung der Pigmentierung und der Vaskularisation, auch die Pigmentdichte war bei 8/13 (62%) zunehmend. Nach Radiotherapie kam es bei den meisten Tieren zu einer initialen deutlichen Besserung. Auch wenn es im weiteren Verlauf oft zu einem erneuten Schub der Erkrankung kam, konnte bei neun bzw. zehn von 13 Tieren (69% bzw. 77%) eine weitere Verschlechterung, wie sie am Kontrollauge auftrat, verhindert werden. Bei allen keratektomierten und bestrahlten Hunden konnte ein alltagstauglicher Visus wiedererlangt und erhalten werden. Ausser einem passageren Blepharospasmus traten keine Nebenwirkungen auf. Schlussfolgerung: Der Verlauf der Keratitis superficialis chronica laesst sich durch eine Bestrahlung mit Sr-90 ohne relevante Nebenwirkungen nachhaltig positiv beeinflussen. Die optimale Therapiesequenz und Dosierung muessen noch erarbeitet werden. (orig.)

Role of cooperative groups and funding source in clinical trials supporting guidelines for systemic therapy of breast cancer.

Science.gov (United States)

Tibau, Ariadna; Anguera, Geòrgia; Andrés-Pretel, Fernando; Templeton, Arnoud J; Seruga, Bostjan; Barnadas, Agustí; Amir, Eitan; Ocana, Alberto

2018-03-13

Clinical research is conducted by academia, cooperative groups (CGs) or pharmaceutical industry. Here, we evaluate the role of CGs and funding sources in the development of guidelines for breast cancer therapies. We identified 94 studies. CGs were involved in 28 (30%) studies while industry either partially or fully sponsored 64 (68%) studies. The number of industry funded studies increased over time (from 0% in 1976 to 100% in 2014; p for trend = 0.048). Only 10 (11%) government or academic studies were identified. Studies conducted by GCs included a greater number of subjects (median 448 vs. 284; p = 0.015), were more common in the neo/adjuvant setting ( p funding was associated with higher likelihood of positive outcomes favoring the sponsored experimental arm ( p = 0.013) but this relationship was not seen for CG-sponsored trials ( p = 0.53). ASCO, ESMO, and NCCN guidelines were searched to identify systemic anti-cancer therapies for early-stage and metastatic breast cancer. Trial characteristics and outcomes were collected. We identified sponsors and/or the funding source(s) and determined whether CGs, industry, or government or academic institutions were involved. Chi-square tests were used for comparison between studies. Industry funding is present in the majority of studies providing the basis for which recommendations about treatment of breast cancer are made. Industry funding, but not CG-based funding, was associated with higher likelihood of positive outcomes in clinical studies supporting guidelines for systemic therapy.

Supported housing for people with severe mental disorders.

Science.gov (United States)

Chilvers, R; Macdonald, G M; Hayes, A A

2006-10-18

There has been a significant reduction in the number of people with severe mental illness who spend extended periods in long-stay hospitals. District health authorities, local authorities, housing associations and voluntary organisations are jointly expected to provide support for people with severe mental disorder/s. This 'support' may well involve some kind of special housing. To determine the effects of supported housing schemes compared with outreach support schemes or 'standard care' for people with severe mental disorder/s living in the community. For the 2006 update we searched the Cochrane Schizophrenia Group Trials Register (April 2006) and the Cochrane Central Register of Controlled Trials (CENTRAL, 2006 Issue 2). We included all relevant randomised, or quasi-randomised, trials dealing with people with 'severe mental disorder/s' allocated to supported housing, compared with outreach support schemes or standard care. We focused on outcomes of service utilisation, mental state, satisfaction with care, social functioning, quality of life and economic data. We reliably selected studies, quality rated them and undertook data extraction. For dichotomous data, we would have estimated relative risks (RR), with the 95% confidence intervals (CI). Where possible, we would have calculated the number needed to treat statistic (NNT). We would have carried out analysis by intention-to-treat and would have summated normal continuous data using the weighted mean difference (WMD). We would have presented scale data for only those tools that had attained pre-specified levels of quality and undertaken tests for heterogeneity and publication bias. Although 139 citations were acquired from the searches, no study met the inclusion criteria. Dedicated schemes whereby people with severe mental illness are located within one site or building with assistance from professional workers have potential for great benefit as they provide a 'safe haven' for people in need of stability and

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

Science.gov (United States)

Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2014-07-16

To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial.

Science.gov (United States)

Murphy, Jill; Goldsmith, Charles H; Jones, Wayne; Oanh, Pham Thi; Nguyen, Vu Cong

2017-05-05

Depressive disorders are one of the leading causes of disease and disability worldwide. In Vietnam, although epidemiological evidence suggests that depression rates are on par with global averages, services for depression are very limited. In a feasibility study that was implemented from 2013 to 2015, we found that a Supported Self-management (SSM) intervention showed promising results for adults with depression in the community in Vietnam. This paper describes the Mental Health in Adults and Children: Frugal Innovations (MAC-FI) trial protocol that will assess the effectiveness of the SSM intervention, delivered by primary care and social workers, to community-based populations of adults with depression in eight Vietnamese provinces. The MAC-FI program will be assessed using a stepped-wedge, randomized controlled trial. Study participants are adults aged 18 years and over in eight provinces of Vietnam. Study participants will be screened at primary care centres and in the community by health and social workers using the Self-reporting Questionnaire-20 (SRQ-20). Patients scoring >7, indicating depression caseness, will be invited to participate in the study in either the SSM intervention group or the enhanced treatment as usual control group. Recruited participants will be further assessed using the World Health Organization's Disability Assessment Scale (WHODAS 2.0) and the Cut-down, Annoyed, Guilty, Eye-opener (CAGE) Questionnaire for alcohol misuse. Intervention-group participants will receive the SSM intervention, delivered with the support of a social worker or social collaborator, for a period of 2 months. Control- group participants will receive treatment as usual and a leaflet with information about depression. SRQ-20, WHODAS 2.0 and CAGE scores will be taken by blinded outcome assessors at baseline, after 1 month and after 2 months. The primary analysis method will be intention-to-treat. This study has the potential to add to the knowledge base about

Effectiveness of web-based versus folder support interventions for young informal carers of persons with mental illness: a randomized controlled trial.

Science.gov (United States)

Ali, Lilas; Krevers, Barbro; Sjöström, Nils; Skärsäter, Ingela

2014-03-01

Compare the impact of two interventions, a web-based support and a folder support, for young persons who care for people who suffer from mental illness. This study was a randomized control trial, following the CONSORT statements, which compared the impact of two interventions. Primary outcome variable was stress, and secondary outcome variables were caring situation, general self-efficacy, well-being, health, and quality of life of young informal carers (N=241). Data were collected in June 2010 to April 2011, with self-assessment questionnaires, comparing the two interventions and also to detect changes. The stress levels were high in both groups at baseline, but decreased in the folder group. The folder group had improvement in their caring situation (also different from the web group), general self-efficacy, well-being, and quality of life. The web group showed increase in well-being. Young informal carers who take on the responsibility for people close to them; suffer consequences on their own health. They live in a life-situation characterized by high stress and low well-being. This signals a need for support. The non-significant differences show that each intervention can be effective, and that it depends upon the individual's preferences. This highlights the importance of adopting person-centered approach, in which young persons can themselves choose support strategy. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

OpenAIRE

Turner, Deborah E; Helliwell, Philip S; Woodburn, James

2007-01-01

Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Method...

The effect of individual enabling and support on empowerment and depression severity in persons with affective disorders: outcome of a randomized control trial.

Science.gov (United States)

Porter, Susann; Bejerholm, Ulrika

2018-01-30

To evaluate the effect of Individual Enabling and Support (IES) on empowerment and depression severity as compared to Traditional Vocational Rehabilitation (TVR) in people with affective disorders at 12 months follow-up. Additionally, longitudinal changes within the intervention groups and the correlation over time between empowerment and depression severity were evaluated. A single-blind randomized controlled trial of two intervention groups, IES (n = 33) and TVR (n = 28), was performed with measurement points at baseline, 6, and 12 months. Individuals with affective disorders, including depression and bipolar disorder diagnoses were included. The Empowerment Scale and Montgomery-Åsberg Depression Self-Rating Scale were administered, and Intention-To-Treat analysis was applied. The study was registered with the trial number ISRCTN93470551. There was a statistically significant difference between the intervention groups on empowerment and depression severity at 12 months. Within-group analysis showed that IES-participants increased their perceived empowerment and decreased their depression severity between measurement points, this was not seen among TVR-participants. A moderate, inverse relationship was detected between empowerment and depression. IES is more effective in increasing empowerment and decreasing depression severity after a 12-month intervention than is TVR. This study was limited by a small sample size and larger trials in different contexts are needed.

Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

Science.gov (United States)

Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun; Gray, Robert; Wang, Xiaofei F; Cronin, Walter; Sargent, Daniel J; Benedetti, Jacqueline; Wickerham, Donald L; Djulbegovic, Benjamin; Slingluff, Craig L

2010-08-01

A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining

Randomized Controlled Trial of Nurse-Delivered Cognitive Behavioral Therapy Versus Supportive Psychotherapy Telehealth Interventions for Chronic Back Pain.

Science.gov (United States)

Rutledge, Thomas; Atkinson, J Hampton; Holloway, Rachael; Chircop-Rollick, Tatiana; D'Andrea, John; Garfin, Steven R; Patel, Shetal; Penzien, Donald B; Wallace, Mark; Weickgenant, Anne L; Slater, Mark

2018-04-16

This study evaluated a nurse-delivered, telehealth intervention of cognitive behavioral therapy versus supportive psychotherapy for chronic back pain. Participants (N=61) had chronic back pain (pain "daily" ≥ 6 months at an intensity ≥4/10 scale) and were randomized to an 8-week, 12-session, Cognitive Behavioral Therapy (CBT) or to Supportive Care (SC) matched for frequency, format, and time, with each treatment delivered by a primary care nurse. The primary outcome was the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included the Numerical Rating Scale (NRS) and the Patient Global Impressions Scale (CGI). CBT participants (n=30) showed significant improvements on the RMDQ (means=11.4[5.9] vs. 9.4[6.1] at baseline and post-treatment, respectively, p.10). The results suggest that telehealth, nurse-delivered CBT and SC treatments for chronic back pain can offer significant and relatively comparable benefits. ClinicalTrials.gov: NCT00608530. This article describes the benefits of training primary care nurses to deliver evidence-based behavioral therapies for low back pain. Due to the high prevalence of chronic pain and the growing emphasis on non-opioid therapies, training nurses to provide behavior therapies could be a cost-effective way to improve pain management. Copyright © 2018. Published by Elsevier Inc.

Clinical trials: bringing research to the bedside.

Science.gov (United States)

Arvay, C A

1991-02-01

Over the years, clinical trials with their structured treatment plans and multicenter involvement have been instrumental in developing new treatments and establishing standard of care therapy. While clinical trials strive to advance medical knowledge, they provide scientifically sound, state of the art care and their use should be increased. The Brain Tumor Cooperative Group, one such NCI-sponsored cooperative group, has been the primary group for the treatment of malignant gliomas. As the field of neuro-oncology expands, the neuroscience nurse needs to develop an understanding of clinical trials and their operation. The nurse is in an optimal position to support medical research and the research participant.

Sagittal spinal balance after lumbar spinal fusion: the impact of anterior column support results from a randomized clinical trial with an eight- to thirteen-year radiographic follow-up.

Science.gov (United States)

Videbaek, Tina S; Bünger, Cody E; Henriksen, Mads; Neils, Egund; Christensen, Finn B

2011-02-01

Randomized clinical trial. To analyze the long-term clinical impact of anterior column support on sagittal balance after lumbar spinal fusion. Several investigators have stressed the importance of maintaining sagittal balance in relation to spinal fusion to avoid lumbar 'flat back,' accelerated adjacent segment degeneration, pain, and inferior functional outcome. Only limited evidence exists on how sagittal alignment affects clinical outcome. Anterior lumbar interbody fusion combined with posterolateral fusion has been proved superior to posterolateral fusion alone regarding outcome and cost-effectiveness. No randomized controlled trial has been published analyzing the effect of anterior support on radiographic measurements of sagittal balance. Between 1996 and 1999, 148 patients with severe chronic low back pain were randomly selected for posterolateral lumbar fusion plus anterior support (PLF + ALIF) or posterolateral lumbar fusion. A total of 92 patients participated. Sagittal balance parameters were examined on full lateral radiographs of the spine: pelvic incidence (PI), pelvic tilt (PT), sacral slope, thoracic kyphosis, lumbar lordosis, and positioning of C7 plumb line. The type of lumbar lordosis was evaluated and outcome assessed by Oswestry Disability Index (ODI). Follow-up rate was 74%. Sagittal balance parameters were similar between randomization groups. None of the parameters differed significantly between patients with an ODI from 0 to 40 and patients with ODI over 40. Balanced patients had a significantly superior outcome as measured by ODI (P Lumbar lordosis and type of lordosis correlated with outcome but could not explain the superior outcome in the group with anterior support. Whether sagittal balance and anterior support during fusion provide a protective effect on adjacent motion segments remains unclear.

Online support groups for women with breast cancer.

Science.gov (United States)

McCaughan, Eilis; Parahoo, Kader; Hueter, Irene; Northouse, Laurel; Bradbury, Ian

2017-03-10

Survival rates for women with a diagnosis of breast cancer continue to improve. However, some women may experience physical, psychological and emotional effects post diagnosis, throughout treatment and beyond. Support groups can provide opportunities for people to share their experiences and learn from others. As the number of online support groups increases, more and more women with breast cancer will likely access them. To assess effects of online support groups on the emotional distress, uncertainty, anxiety, depression and quality of life (QoL) of women with breast cancer. We searched for trials in the Cochrane Breast Cancer Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 4), MEDLINE, Embase and PsycINFO on 2 May 2016, and we handsearched journals and reference lists. We also searched the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) search portal and clinicaltrials.gov on 2 May 2016. We included randomised controlled trials (RCTs) assessing effects of online support groups on women with a diagnosis of breast cancer and women who have completed breast cancer treatment. We included studies comparing online support groups with a usual care group, and studies comparing two or more types of online support groups (without a usual care group). Two review authors independently extracted data and assessed risk of bias. We presented outcome data using mean differences (MDs) and standardised mean differences (SMDs) along with 95% confidence intervals (CIs), and we used the fixed-effect model when appropriate. We assessed the quality of the body of evidence using the GRADE approach. We included six studies (492 women) that assessed online support groups for women with breast cancer. Online support groups in these six trials lasted from six to 30 weeks. Women participated in these groups between 1.5 and 2.5 hours per week, and investigators conducted all studies in the USA

Clinical Trials: Information and Options for People with Mood Disorders

Science.gov (United States)

... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... contribution made by a clinical trial is to science first and to the patient second. back to ...

Low perceived social support and post-myocardial infarction prognosis in the enhancing recovery in coronary heart disease clinical trial: the effects of treatment.

Science.gov (United States)

Burg, Matthew M; Barefoot, John; Berkman, Lisa; Catellier, Diane J; Czajkowski, Susan; Saab, Patrice; Huber, Marc; DeLillo, Vicki; Mitchell, Pamela; Skala, Judy; Taylor, C Barr

2005-01-01

In post hoc analyses, to examine in low perceived social support (LPSS) patients enrolled in the Enhancing Recovery in Coronary Heart Disease (ENRICHD) clinical trial (n = 1503), the pattern of social support following myocardial infarction (MI), the impact of psychosocial intervention on perceived support, the relationship of perceived support at the time of MI to subsequent death and recurrent MI, and the relationship of change in perceived support 6 months after MI to subsequent mortality. Partner status (partner, no partner) and score (12 = moderate support) on the ENRICHD Social Support Instrument (ESSI) were used post hoc to define four levels of risk. The resulting 4 LPSS risk groups were compared on baseline characteristics, changes in social support, and medical outcomes to a group of concurrently enrolled acute myocardial infarction patients without depression or LPSS (MI comparison group, n = 408). Effects of treatment assignment on LPSS and death/recurrent MI were also examined. All 4 LPSS risk groups demonstrated improvement in perceived support, regardless of treatment assignment, with a significant treatment effect only seen in the LPSS risk group with no partner and moderate support at baseline. During an average 29-month follow-up, the combined end point of death/nonfatal MI was 10% in the MI comparison group and 23% in the ENRICHD LPSS patients; LPSS conferred a greater risk in unadjusted and adjusted models (HR = 1.74-2.39). Change in ESSI score and/or improvement in perceived social support were not found to predict subsequent mortality. Baseline LPSS predicted death/recurrent MI in the ENRICHD cohort, independent of treatment assignment. Intervention effects indicated a partner surrogacy role for the interventionist and the need for a moderate level of support at baseline for the intervention to be effective.

A Challenge-Based Approach to Body Weight-Supported Treadmill Training Poststroke: Protocol for a Randomized Controlled Trial.

Science.gov (United States)

Naidu, Avantika; Brown, David; Roth, Elliot

2018-05-03

exploratory secondary outcome measures. Additionally, we will also assess participant responses to a study survey, conducted at the end of training week, to gauge each group's training experiences. Our treadmill training paradigms, and study protocol represent advances in standardized approaches to selecting body weight support levels without the necessity for using handrails or manual assistance, while progressively providing dynamic challenges for improving poststroke ambulatory function during rehabilitation. ClinicalTrials.gov NCT02787759; https://clinicaltrials.gov/ct2/show/NCT02787759 (Archived by Webcite at http://www.webcitation.org/6yJZCrIea). ©Avantika Naidu, David Brown, Elliot Roth. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.05.2018.

Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial

Directory of Open Access Journals (Sweden)

Capozzi Lauren C

2012-10-01

Full Text Available Abstract Background Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck (HN cancer populations. This translates into a lack of clinical programming available for these patient populations. HN cancer patients deal with severe weight loss, with more than 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL, and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Our pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Methods/Design Therefore, the purpose of the present study is to examine the impact and timing of a 12-week PA and nutrition intervention (either during or following treatment for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, we will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects, as well as return to work. Discussion This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical-activity and wellness-education model that can be implemented in other cancer centers. Trial registration Current Controlled Trials NCT01681654

Computer-Based Driving in Dementia Decision Tool With Mail Support: Cluster Randomized Controlled Trial.

Science.gov (United States)

Rapoport, Mark J; Zucchero Sarracini, Carla; Kiss, Alex; Lee, Linda; Byszewski, Anna; Seitz, Dallas P; Vrkljan, Brenda; Molnar, Frank; Herrmann, Nathan; Tang-Wai, David F; Frank, Christopher; Henry, Blair; Pimlott, Nicholas; Masellis, Mario; Naglie, Gary

2018-05-25

Physicians often find significant challenges in assessing automobile driving in persons with mild cognitive impairment and mild dementia and deciding when to report to transportation administrators. Care must be taken to balance the safety of patients and other road users with potential negative effects of issuing such reports. The aim of this study was to assess whether a computer-based Driving in Dementia Decision Tool (DD-DT) increased appropriate reporting of patients with mild dementia or mild cognitive impairment to transportation administrators. The study used a parallel-group cluster nonblinded randomized controlled trial design to test a multifaceted knowledge translation intervention. The intervention included a computer-based decision support system activated by the physician-user, which provides a recommendation about whether to report patients with mild dementia or mild cognitive impairment to transportation administrators, based on an algorithm derived from earlier work. The intervention also included a mailed educational package and Web-based specialized reporting forms. Specialists and family physicians with expertise in dementia or care of the elderly were stratified by sex and randomized to either use the DD-DT or a control version of the tool that required identical data input as the intervention group, but instead generated a generic reminder about the reporting legislation in Ontario, Canada. The trial ran from September 9, 2014 to January 29, 2016, and the primary outcome was the number of reports made to the transportation administrators concordant with the algorithm. A total of 69 participating physicians were randomized, and 36 of these used the DD-DT; 20 of the 35 randomized to the intervention group used DD-DT with 114 patients, and 16 of the 34 randomized to the control group used it with 103 patients. The proportion of all assessed patients reported to the transportation administrators concordant with recommendation did not differ

Body weight-supported treadmill training vs. overground walking training for persons with chronic stroke: a pilot randomized controlled trial.

Science.gov (United States)

Combs-Miller, Stephanie A; Kalpathi Parameswaran, Anu; Colburn, Dawn; Ertel, Tara; Harmeyer, Amanda; Tucker, Lindsay; Schmid, Arlene A

2014-09-01

To compare the effects of body weight-supported treadmill training and overground walking training when matched for task and dose (duration/frequency/intensity) on improving walking function, activity, and participation after stroke. Single-blind, pilot randomized controlled trial with three-month follow-up. University and community settings. A convenience sample of participants (N = 20) at least six months post-stroke and able to walk independently were recruited. Thirty-minute walking interventions (body weight-supported treadmill training or overground walking training) were administered five times a week for two weeks. Intensity was monitored with the Borg Rating of Perceived Exertion Scale at five-minute increments to maintain a moderate training intensity. Walking speed (comfortable/fast 10-meter walk), walking endurance (6-minute walk), spatiotemporal symmetry, and the ICF Measure of Participation and ACTivity were assessed before, immediately after, and three months following the intervention. The overground walking training group demonstrated significantly greater improvements in comfortable walking speed compared with the body weight-supported treadmill training group immediately (change of 0.11 m/s vs. 0.06 m/s, respectively; p = 0.047) and three months (change of 0.14 m/s vs. 0.08 m/s, respectively; p = 0.029) after training. Only the overground walking training group significantly improved comfortable walking speed (p = 0.001), aspects of gait symmetry (p = 0.032), and activity (p = 0.003) immediately after training. Gains were maintained at the three-month follow-up (p training was more beneficial than body weight-supported treadmill training at improving self-selected walking speed for the participants in this study. © The Author(s) 2014.

Emotion Recognition from Single-Trial EEG Based on Kernel Fisher’s Emotion Pattern and Imbalanced Quasiconformal Kernel Support Vector Machine

Directory of Open Access Journals (Sweden)

Yi-Hung Liu

2014-07-01

Full Text Available Electroencephalogram-based emotion recognition (EEG-ER has received increasing attention in the fields of health care, affective computing, and brain-computer interface (BCI. However, satisfactory ER performance within a bi-dimensional and non-discrete emotional space using single-trial EEG data remains a challenging task. To address this issue, we propose a three-layer scheme for single-trial EEG-ER. In the first layer, a set of spectral powers of different EEG frequency bands are extracted from multi-channel single-trial EEG signals. In the second layer, the kernel Fisher’s discriminant analysis method is applied to further extract features with better discrimination ability from the EEG spectral powers. The feature vector produced by layer 2 is called a kernel Fisher’s emotion pattern (KFEP, and is sent into layer 3 for further classification where the proposed imbalanced quasiconformal kernel support vector machine (IQK-SVM serves as the emotion classifier. The outputs of the three layer EEG-ER system include labels of emotional valence and arousal. Furthermore, to collect effective training and testing datasets for the current EEG-ER system, we also use an emotion-induction paradigm in which a set of pictures selected from the International Affective Picture System (IAPS are employed as emotion induction stimuli. The performance of the proposed three-layer solution is compared with that of other EEG spectral power-based features and emotion classifiers. Results on 10 healthy participants indicate that the proposed KFEP feature performs better than other spectral power features, and IQK-SVM outperforms traditional SVM in terms of the EEG-ER accuracy. Our findings also show that the proposed EEG-ER scheme achieves the highest classification accuracies of valence (82.68% and arousal (84.79% among all testing methods.

Spine device clinical trials: design and sponsorship.

Science.gov (United States)

Cher, Daniel J; Capobianco, Robyn A

2015-05-01

Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

New EORTC clinical trials for BNCT

International Nuclear Information System (INIS)

Hideghety, K.; Moss, R.; Vries, M. de

2000-01-01

Due to ethical reasons, a separated optimization of the two components of BNCT in the frame of clinical investigations can only be performed applying the whole binary system. The ongoing trial at HFR (High Flux Reactor Petten) has proven the feasibility of BNCT under defined conditions. On that basis the European Commission supported a comprehensive research project on boron imaging including three further clinical studies. In the first trial the boron uptake related to the blood boron concentration and surrounding normal tissue in various solid tumours will be examined using BSH (Sodiumborocaptate), BPA (Boronophenylalanine) or both in order to explore tumour entities, which may gain benefit from BNCT. The major objectives of the second trial are to define the maximum tolerated single and cumulative dose, and the dose limiting toxicity of BSH. The third clinical trial, a phase II study is designed to evaluate the anti-tumour effect of fractionated BNCT at the Petten treatment facility against cerebral metastasis of malignant melanoma using BPA. (author)

Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar.

Science.gov (United States)

Roberto, Anna; Radrezza, Silvia; Mosconi, Paola

2018-04-10

In recent years the question of the lack of transparency in clinical research has been debated by clinicians, researchers, citizens and their representatives, authors and publishers. This is particularly important for infrequent cancers such as ovarian cancer, where treatment still gives disappointing results in the majority of cases. Our aim was to assess the availability to the public of results in ClinicalTrials.gov, and the frequency of non-publication of results in ClinicalTrials.gov and in PubMed, Embase and Google Scholar. We collected all trials on ovarian cancer identified as "completed status" in the ClinicalTrials.gov registry on 17 January 2017. We checked the availability of the results in ClinicalTrials.gov and systematically identified published manuscripts on results. Out of 2725 trials on ovarian cancer identified, 752 were classified as "completed status". In those closed between 2008 and 2015, excluding phase I, the frequency of results in ClinicalTrials.gov was 35%. Of the 752 completed studies the frequency of published results in PubMed, Embase or Google Scholar ranged from 57.9% to 69.7% in the last years. These findings show a lack of transparency and credibility of research. Citizens or patients' representatives, with the medical community, should continuously support initiatives to improve the publication and dissemination of clinical study results.

Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450

Directory of Open Access Journals (Sweden)

Hutton JL

2005-01-01

Full Text Available Abstract Background The optimal management for severe sprains (Grades II and III of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1 the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast® brace and Bledsoe® boot in comparison to Tubigrip®, and (2 to compare the cost of each strategy, including subsequent health care costs. Methods/design Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. Discussion This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

Project TEAMS (Talking about Eating, Activity, and Mutual Support): a randomized controlled trial of a theory-based weight loss program for couples.

Science.gov (United States)

Gorin, Amy A; Powers, Theodore A; Gettens, Katelyn; Cornelius, Talea; Koestner, Richard; Mobley, Amy R; Pescatello, Linda; Medina, Tania Huedo

2017-09-29

Obesity risk is shared between spouses, yet existing weight loss programs focus on individuals and not the marital dyad. Given the interdependence of weight in couples, weight management outcomes might be improved by targeting joint weight loss and the creation of an interpersonal milieu that supports long-term behavior change. According to Self-Determination Theory (SDT), greater autonomous self-regulation of behaviors, and subsequently better treatment outcomes, are observed in needs supportive environments in which personally meaningful choice is supported and criticism and control are minimized. Correlational analyses confirm these pathways in weight management, with needs support from one's spouse or partner emerging as a distinct predictor of weight loss success. Research is now needed to establish causal links and to develop and test weight loss interventions designed to facilitate the needs supportive behavior of spouses. Project TEAMS (Talking about Eating, Activity, and Mutual Support) is a randomized controlled trial testing a couples-based intervention, grounded in SDT, designed to change the social context of weight loss by training spouses to provide needs support for each other's eating and physical activity behavior. Sixty-four couples will be randomized to either 6 months of behavioral weight loss treatment informed by SDT (SDT-WL) or to 6 months of standard behavioral weight loss treatment (BWL). Couples will attend weekly sessions for 6 months and will be assessed at 0, 3, 6, and 12 months. By bolstering needs support, SDT-WL is predicted to increase autonomous self-regulation and perceived competence and produce greater weight loss and maintenance than standard behavioral treatment. Exploratory analyses will examine the SDT process model prediction that the influence of needs support on treatment outcomes will be mediated by autonomous self-regulation and perceived competence. This study addresses the fundamental importance of interpersonal

Informed consent in clinical trials: Perceptions and experiences of a ...

African Journals Online (AJOL)

It is recommended that more recognition be given to the important role of trial counsellors in clinical trials, and that they be given more formal training, support and ... Daar word aanbeveel dat meer erkenning gegee word aan die rol van proefvoorligters in kliniese proewe, dat hulle meer formele opleiding ondergaan, dat ...

Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial.

Science.gov (United States)

Li, Jin; Qin, Shukui; Xu, Ruihua; Yau, Thomas C C; Ma, Brigette; Pan, Hongming; Xu, Jianming; Bai, Yuxian; Chi, Yihebali; Wang, Liwei; Yeh, Kun-Huei; Bi, Feng; Cheng, Ying; Le, Anh Tuan; Lin, Jen-Kou; Liu, Tianshu; Ma, Dong; Kappeler, Christian; Kalmus, Joachim; Kim, Tae Won

2015-06-01

In the international randomised phase 3 CORRECT trial (NCT01103323), regorafenib significantly improved overall survival versus placebo in patients with treatment-refractory metastatic colorectal cancer. Of the 760 patients in CORRECT, 111 were Asian (mostly Japanese). This phase 3 trial was done to assess regorafenib in a broader population of Asian patients with refractory metastatic colorectal cancer than was studied in CORRECT. In this randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done in 25 hospitals in mainland China, Hong Kong, South Korea, Taiwan, and Vietnam, we recruited Asian patients aged 18 years or older with progressive metastatic colorectal cancer who had received at least two previous treatment lines or were unable to tolerate standard treatments. Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 3 months, and adequate bone marrow, liver, and renal function, without other uncontrolled medical disorders. We randomly allocated patients (2:1; with a computer-generated unicentric randomisation list [prepared by the study funder] and interactive voice response system; block size of six; stratified by metastatic site [single vs multiple organs] and time from diagnosis of metastatic disease [regorafenib 160 mg once daily or placebo on days 1-21 of each 28 day cycle; patients in both groups were also to receive best supportive care. Participants, investigators, and the study funder were masked to treatment assignment. The primary endpoint was overall survival, and we analysed data on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01584830. Between April 29, 2012, and Feb 6, 2013, we screened 243 patients and randomly assigned 204 patients to receive either regorafenib (136 [67%]) or placebo (68 [33%]). After a median follow-up of 7·4 months (IQR 4·3-12·2), overall survival was significantly better with regorafenib

Weight Loss Maintenance for 2 Years after a 6-Month Randomised Controlled Trial Comparing Education-Only and Group-Based Support in Japanese Adults

Directory of Open Access Journals (Sweden)

Yoshio Nakata

2014-11-01

Full Text Available Objective: Our previous study, a 6-month randomised controlled trial, demonstrated that a group-based support promoted weight loss as compared to an education-only intervention. The purpose of this study was to examine weight loss maintenance for 2 years. Methods: Originally, 188 overweight Japanese adults, aged 40-65 years, were randomly assigned to 3 groups: control, education-only or group-based support. After the 6-month intervention, 125 participants in the education-only and the group-based support groups were followed up for 2 years. The primary outcome was the amount of weight lost. The participants were retrospectively grouped into quartiles of percent weight loss for secondary analyses. Results: At the end of follow-up, the amount of weight lost in the education-only and the group-based support groups was the same (3.3 kg. Secondary analyses using data of those who completed the study (n = 100 revealed that the participants in the highest quartile of percent weight loss significantly increased their step counts and moderate-to-vigorous physical activity compared with the lowest quartile. No significant differences were observed in the energy intake among the four groups. Conclusion: The effects of group-based support disappear within 2 years. Increasing physical activity may be a crucial factor for successful maintenance of weight loss.

Direct to Public Peer Support and e-Therapy Program Versus Information to Aid Self-Management of Depression and Anxiety: Protocol for a Randomized Controlled Trial.

Science.gov (United States)

Kaylor-Hughes, Catherine J; Rawsthorne, Mat; Coulson, Neil S; Simpson, Sandra; Simons, Lucy; Guo, Boliang; James, Marilyn; Moran, Paul; Simpson, Jayne; Hollis, Chris; Avery, Anthony J; Tata, Laila J; Williams, Laura; Morriss, Richard K

2017-12-18

Regardless of geography or income, effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe, anonymized public health-driven Web-based services such as Big White Wall (BWW), which offer immediate peer support at low cost. Using Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) methodology, the aim of this study was to determine the population reach, effectiveness, cost-effectiveness, and barriers and drivers to implementation of BWW compared with Web-based information compiled by UK's National Health Service (NHS, NHS Choices Moodzone) in people with probable mild to moderate depression and anxiety disorder. A pragmatic, parallel-group, single-blind randomized controlled trial (RCT) is being conducted using a fully automated trial website in which eligible participants are randomized to receive either 6 months access to BWW or signposted to the NHS Moodzone site. The recruitment of 2200 people to the study will be facilitated by a public health engagement campaign involving general marketing and social media, primary care clinical champions, health care staff, large employers, and third sector groups. People will refer themselves to the study and will be eligible if they are older than 16 years, have probable mild to moderate depression or anxiety disorders, and have access to the Internet. The primary outcome will be the Warwick-Edinburgh Mental Well-Being Scale at 6 weeks. We will also explore the reach, maintenance, cost-effectiveness, and barriers and drivers to implementation and possible mechanisms of actions using a range of qualitative and quantitative methods. This will be the first fully digital trial of a direct to public online peer support program for common mental disorders. The potential advantages of adding this to current NHS mental health services and the challenges of designing a public health campaign and RCT of

Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial.

Science.gov (United States)

Edbrooke, Lara; Aranda, Sanchia; Granger, Catherine L; McDonald, Christine F; Krishnasamy, Mei; Mileshkin, Linda; Irving, Louis; Braat, Sabine; Clark, Ross A; Gordon, Ian; Denehy, Linda

2017-09-29

Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC. This multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference. There is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly

The Use of Cell Phone Support for Non-adherent HIV-Infected Youth and Young Adults: An Initial Randomized and Controlled Intervention Trial

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Belzer, Marvin E.; Naar-King, Sylvie; Olson, Johanna; Sarr, Moussa; Thornton, Sarah; Kahana, Shoshana Y.; Gaur, Aditya H.; Clark, Leslie F.

2014-01-01

This randomized behavioral trial examined whether youth living with HIV (YLH) receiving cell-phone support with study funded phone plans, demonstrated improved adherence and viral control during the 24 week intervention and 24 weeks post-intervention compared to controls. Monday through Friday phone calls confirmed medications were taken, provided problem-solving support, and referred to services to address adherence barriers. Of 37 participants (ages 15–24), 62 % were male and 70 % were African American. Self-reported adherence was significantly higher in the intervention group compared to the control at 24 and 48 weeks for the past month (P = 0.007) and log 10 HIV VL was significantly lower at both 24 weeks (2.82 versus 4.52 P = 0.002) and 48 weeks (3.23 versus 4.23 P = 0.043). Adherence and viral load showed medium to large effect sizes across the 48 week study. This is the first study to demonstrate sustained clinically significant reductions in HIV VL using youth friendly technology. PMID:24271347

TU-C-9A-01: IROC Organization and Clinical Trial Credentialing

International Nuclear Information System (INIS)

Followill, D; Molineu, A; Xiao, Y

2014-01-01

As a response to recommendations from a report from the Institute of Medicine, NCI is reorganizing it clinical trial groups into a National Clinical Trial Network (NCTN) that consists of four adult groups (Alliance, ECOGACRIN, NRG, and SWOG) and one children’s group (COG). NRG will house CIRO, a center to promote innovative radiation therapy research and intergroup collaboration in radiation. The quality assurance groups that support clinical trials have also been restructured. ITC, OSU Imaging corelab, Philadelphia Imaging core-lab, QARC, RPC, and RTOGQA have joined together to create the Imaging and Radiation Oncology Core (IROC) Group. IROC’s mission is to provide integrated radiation oncology and diagnostic imaging quality control programs in support of the NCI’s NCTN thereby assuring high quality data for clinical trials designed to improve the clinical outcomes for cancer patients worldwide. This will be accomplished through five core services: site qualification, trial design support, credentialing, data management, case review.These changes are important for physicist participating in NCI clinical trials to understand. We will describe in detail the IROC’s activities and five core services so that as a user, the medical physicist can learn how to efficiently utilize this group. We will describe common pitfalls encountered in credentialing for current protocols and present methods to avoid them. These may include the which benchmarks are required for NSABP B-51/RTOG 1304 and how to plan them as well as tips for phantom planning. We will explain how to submit patient and phantom cases in the TRIAD system used by IROC. Learning Objectives: To understand the basic organization of IROC, its mission and five core services To learn how to use TRIAD for patient and phantom data submission To learn how to avoid common pitfalls in credentialing for current trials

[Osteopathie bei gastroösophagealem Reflux mit Hiatushernie: Ein Fallbericht gemäß der CARE-Leitlinie].

Science.gov (United States)

Rotter, Gabriele; Brinkhaus, Benno

2017-01-01

Hintergrund: Das Vorhandensein einer Hiatushernie kann das Auftreten einer gastroösophagealen Refluxerkrankung (GERD) als Komplikation bedingen. Konventionelle medizinische Therapiemaßnahmen können zu unerwünschten Ereignissen und Rezidiven führen. Bisher sind die Effekte von osteopathischen Behandlungen bei Hiatushernie und GERD nicht bekannt. Fallbericht: Eine 59-jährige Patientin mit endoskopisch diagnostizierter chronischer Gastritis, GERD und Hiatushernie beklagte einen persistierenden gastroösophagealen Reflux trotz konventionell-medizinischer konservativer Therapie. Die osteopathische Diagnostik ergab eine funktionelle Störung im Bereich des Magens und der Kardia mit einer Beteiligung zugehöriger Reflexzonen. Nach einer osteopathischen Behandlung als individuelle, befundorientierte Therapie ließen die Beschwerden erheblich nach. Die Hiatushernie war nach einer dieser Behandlung endoskopisch nicht mehr nachweisbar. Schlussfolgerungen: Dieser Fallbericht schildert die Symptomreduktion einer GERD nach osteopathischer Behandlung. In der endoskopischen Folgeuntersuchung fand sich die initial diagnostizierte Hiatushernie nicht mehr, diese Befund änderung könnte jedoch auf die unterschiedlichen Untersucher zurückgeführt werden. Prospektive kontrollierte klinische Studien sind notwendig, um den Stellenwert von osteopathischen Behandlungen bei GERD mit Hiatushernie zu untersuchen. © 2017 The Author(s). Published by S. Karger GmbH, Freiburg.

Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial.

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Ashford, Miriam T; Olander, Ellinor K; Rowe, Heather; Fisher, Jane Rw; Ayers, Susan

2018-04-20

Postpartum anxiety can have adverse effects on the mother and child if left untreated. Time constraints and stigma are common barriers to postpartum treatment. Web-based treatments offer potential flexibility and anonymity. What Am I Worried About (WaWa) is a self-guided treatment based on cognitive-behavioral and mindfulness principles for women experiencing postpartum anxiety. WaWa was developed in Australia and consists of 9 modules with optional weekly telephone support. WaWa was adapted to a Web-based version for use in England (Internet-based What Am I Worried About, iWaWa). This study aimed to investigate the feasibility (engagement and usability) and acceptability (usefulness, satisfaction, and helpfulness) of iWaWa among English postpartum women with anxiety. Postpartum (parenting styles. Despite interest in iWaWa, the results suggest that both the study and iWaWa were not feasible in the current format. However, this first trial provides useful evidence about treatment format and content preferences that can inform iWaWa's future development, as well as research and development of Web-based postpartum anxiety treatments, in general, to optimize adherence. ClinicalTrials.gov NCT02434406; https://clinicaltrials.gov/ct2/show/NCT02434406 (Archived by WebCite at http://www.webcitation.org/6xTq7Bwmd). ©Miriam T Ashford, Ellinor K Olander, Heather Rowe, Jane RW Fisher, Susan Ayers. Originally published in JMIR Mental Health (http://mental.jmir.org), 20.04.2018.

A cluster randomized controlled trial evaluating the efficacy of peer mentors to support South African women living with HIV and their infants.

Directory of Open Access Journals (Sweden)

Mary Jane Rotheram-Borus

Full Text Available We evaluate the effect of clinic-based support by HIV-positive Peer Mentors, in addition to standard clinic care, on maternal and infant well-being among Women Living with HIV (WLH from pregnancy through the infant's first year of life.In a cluster randomized controlled trial in KwaZulu-Natal, South Africa, eight clinics were randomized for pregnant WLH to receive either: a Standard Care condition (SC; 4 clinics; n = 656 WLH; or an Enhanced Intervention (EI; 4 clinics; n = 544 WLH. WLH in the EI were invited to attend four antenatal and four postnatal meetings led by HIV-positive Peer Mentors, in addition to SC. WLH were recruited during pregnancy, and at least two post-birth assessment interviews were completed by 57% of WLH at 1.5, 6 or 12 months. EI's effect was ascertained on 19 measures of maternal and infant well-being using random effects regressions to control for clinic clustering. A binomial test for correlated outcomes evaluated EI's overall efficacy.WLH attended an average of 4.1 sessions (SD = 2.0; 13% did not attend any sessions. Significant overall benefits were found in EI compared to SC using the binomial test. Secondarily, over time, WLH in the EI reported significantly fewer depressive symptoms and fewer underweight infants than WLH in the SC condition. EI WLH were significantly more likely to use one feeding method for six months and exclusively breastfeed their infants for at least 6 months.WLH benefit by support from HIV-positive Peer Mentors, even though EI participation was partial, with incomplete follow-up rates from 6-12 months.ClinicalTrials.gov NCT00972699.

Leidos Biomed Supports Clinical Trials for Vaccine Against Mosquito-borne Chikungunya | FNLCR Staging

Science.gov (United States)

An experimental vaccine for mosquito-borne chikungunya is being tested at sites in the Caribbean as part of a phase II clinical trial being managed by the Frederick National Lab. No vaccine or treatment currently exists for the viral disease, which c

Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol

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DePaul Vincent G

2011-10-01

Full Text Available Abstract Background Although task-oriented training has been shown to improve walking outcomes after stroke, it is not yet clear whether one task-oriented approach is superior to another. The purpose of this study is to compare the effectiveness of the Motor Learning Walking Program (MLWP, a varied overground walking task program consistent with key motor learning principles, to body-weight-supported treadmill training (BWSTT in community-dwelling, ambulatory, adults within 1 year of stroke. Methods/Design A parallel, randomized controlled trial with stratification by baseline gait speed will be conducted. Allocation will be controlled by a central randomization service and participants will be allocated to the two active intervention groups (1:1 using a permuted block randomization process. Seventy participants will be assigned to one of two 15-session training programs. In MLWP, one physiotherapist will supervise practice of various overground walking tasks. Instructions, feedback, and guidance will be provided in a manner that facilitates self-evaluation and problem solving. In BWSTT, training will emphasize repetition of the normal gait cycle while supported over a treadmill, assisted by up to three physiotherapists. Outcomes will be assessed by a blinded assessor at baseline, post-intervention and at 2-month follow-up. The primary outcome will be post-intervention comfortable gait speed. Secondary outcomes include fast gait speed, walking endurance, balance self-efficacy, participation in community mobility, health-related quality of life, and goal attainment. Groups will be compared using analysis of covariance with baseline gait speed strata as the single covariate. Intention-to-treat analysis will be used. Discussion In order to direct clinicians, patients, and other health decision-makers, there is a need for a head-to-head comparison of different approaches to active, task-related walking training after stroke. We hypothesize that

Tailored educational supportive care programme on sleep quality and psychological distress in patients with heart failure: A randomised controlled trial.

Science.gov (United States)

Chang, Yia-Ling; Chiou, Ai-Fu; Cheng, Shu-Meng; Lin, Kuan-Chia

2016-09-01

Up to 74% of patients with heart failure report poor sleep in Taiwan. Poor symptom management or sleep hygiene may affect patients' sleep quality. An effective educational programme was important to improve patients' sleep quality and psychological distress. However, research related to sleep disturbance in patients with heart failure is limited in Taiwan. To examine the effects of a tailored educational supportive care programme on sleep disturbance and psychological distress in patients with heart failure. randomised controlled trial. Eighty-four patients with heart failure were recruited from an outpatient department of a medical centre in Taipei, Taiwan. Patients were randomly assigned to the intervention group (n=43) or the control group (n=41). Patients in the intervention group received a 12-week tailored educational supportive care programme including individualised education on sleep hygiene, self-care, emotional support through a monthly nursing visit at home, and telephone follow-up counselling every 2 weeks. The control group received routine nursing care. Data were collected at baseline, the 4th, 8th, and 12th weeks after patients' enrollment. Outcome measures included sleep quality, daytime sleepiness, anxiety, and depression. The intervention group exhibited significant improvement in the level of sleep quality and daytime sleepiness after 12 weeks of the supportive nursing care programme, whereas the control group exhibited no significant differences. Anxiety and depression scores were increased significantly in the control group at the 12th week (p.05). Compared with the control group, the intervention group had significantly greater improvement in sleep quality (β=-2.22, pquality and psychological distress in patients with heart failure. We suggested that this supportive nursing care programme should be applied to clinical practice in cardiovascular nursing. Copyright © 2016 Elsevier Ltd. All rights reserved.

Rottlerin impairs the formation and maintenance of psychostimulant-supported memory.

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Liao, Tien You; Tzeng, Wen-Yu; Wu, Hsin-Hua; Cherng, Chianfang G; Wang, Ching-Yi; Hu, Sherry S-J; Yu, Lung

2016-04-01

Since brain proteins such as protein kinase C (PKC), brain-derived neurotrophic factor (BDNF), and mammalian target of rapamycin (mTOR) are involved in the establishment and maintenance of psychostimulant memory, we sought to determine if systemic treatment with rottlerin, a natural compound affecting all these proteins, may modulate stimulant-supported memory. Stimulant-induced conditioned place preference (CPP) was used in modeling stimulant-supported memory. Three cocaine (10 mg/kg; COC) or three methamphetamine (1 mg/kg; MA) conditioning trials reliably established the drug-induced CPP in male C57BL/6 mice. An intra-peritoneal rottlerin injection (5 mg/kg) at least 24 h prior to the first COC or first MA conditioning trial prevented the establishment of CPP. Following the establishment of the COC- or MA-induced CPP, saline conditioning trial was used to extinguish the CPP. Rottlerin (5 mg/kg, intra-peritoneal (i.p.)) administered 20 h prior to the first saline conditioning trial diminished subsequent drug- and stressor-primed reinstatement of the extinguished CPP. Rottlerin (5 mg/kg, i.p.) produced a fast-onset and long-lasting increase in hippocampal BDNF levels. However, treatment with a BDNF tropomyosin receptor kinase B (TrkB) receptor antagonist, K252a (5 μg/kg), did not affect rottlerin's suppressing effect on COC-induced CPP and treatment with 7,8-dihydroxyflavone (10 mg/kg x 6, 7,8-DHF), a selective TrkB agonist, prior to each conditioning trial did not affect COC-induced CPP. These results suggest that systemic rottlerin treatment may impair the formation of COC- and MA-supported memory. Importantly, such a treatment may advance our understanding of the underlying mechanism through which extinction training resulted in the "forgetting" of the COC- and MA-supported memory.

Investigating the cost-effectiveness of videotelephone based support for newly diagnosed paediatric oncology patients and their families: design of a randomised controlled trial

Directory of Open Access Journals (Sweden)

Theodoros Deborah

2007-03-01

Full Text Available Abstract Background Providing ongoing family centred support is an integral part of childhood cancer care. For families living in regional and remote areas, opportunities to receive specialist support are limited by the availability of health care professionals and accessibility, which is often reduced due to distance, time, cost and transport. The primary aim of this work is to investigate the cost-effectiveness of videotelephony to support regional and remote families returning home for the first time with a child newly diagnosed with cancer Methods/design We will recruit 162 paediatric oncology patients and their families to a single centre randomised controlled trial. Patients from regional and remote areas, classified by Accessibility/Remoteness Index of Australia (ARIA+ greater than 0.2, will be randomised to a videotelephone support intervention or a usual support control group. Metropolitan families (ARIA+ ≤ 0.2 will be recruited as an additional usual support control group. Families allocated to the videotelephone support intervention will have access to usual support plus education, communication, counselling and monitoring with specialist multidisciplinary team members via a videotelephone service for a 12-week period following first discharge home. Families in the usual support control group will receive standard care i.e., specialist multidisciplinary team members provide support either face-to-face during inpatient stays, outpatient clinic visits or home visits, or via telephone for families who live far away from the hospital. The primary outcome measure is parental health related quality of life as measured using the Medical Outcome Survey (MOS Short Form SF-12 measured at baseline, 4 weeks, 8 weeks and 12 weeks. The secondary outcome measures are: parental informational and emotional support; parental perceived stress, parent reported patient quality of life and parent reported sibling quality of life, parental satisfaction

Using Getting To Outcomes to facilitate the use of an evidence-based practice in VA homeless programs: a cluster-randomized trial of an implementation support strategy.

Science.gov (United States)

Chinman, Matthew; McCarthy, Sharon; Hannah, Gordon; Byrne, Thomas Hugh; Smelson, David A

2017-03-09

Incorporating evidence-based integrated treatment for dual disorders into typical care settings has been challenging, especially among those serving Veterans who are homeless. This paper presents an evaluation of an effort to incorporate an evidence-based, dual disorder treatment called Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking-Veterans Edition (MISSION-Vet) into case management teams serving Veterans who are homeless, using an implementation strategy called Getting To Outcomes (GTO). This Hybrid Type III, cluster-randomized controlled trial assessed the impact of GTO over and above MISSION-Vet Implementation as Usual (IU). Both conditions received standard MISSION-Vet training and manuals. The GTO group received an implementation manual, training, technical assistance, and data feedback. The study occurred in teams at three large VA Medical Centers over 2 years. Within each team, existing sub-teams (case managers and Veterans they serve) were the clusters randomly assigned. The trial assessed MISSION-Vet services delivered and collected via administrative data and implementation barriers and facilitators, via semi-structured interview. No case managers in the IU group initiated MISSION-Vet while 68% in the GTO group did. Seven percent of Veterans with case managers in the GTO group received at least one MISSION-Vet session. Most case managers appreciated the MISSION-Vet materials and felt the GTO planning meetings supported using MISSION-Vet. Case manager interviews also showed that MISSION-Vet could be confusing; there was little involvement from leadership after their initial agreement to participate; the data feedback system had a number of difficulties; and case managers did not have the resources to implement all aspects of MISSION-Vet. This project shows that GTO-like support can help launch new practices but that multiple implementation facilitators are needed for successful execution of a complex evidence

Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial.

Science.gov (United States)

Hatcher, Simon; Whittaker, Robyn; Patton, Murray; Miles, Wayne Sylvester; Ralph, Nicola; Kercher, Katharina; Sharon, Cynthia

2018-01-23

The evidence for the effectiveness of Web-based therapies comes mainly from nonclinical populations, with a few studies in primary care. There is little evidence from patients referred to secondary mental health care with depression. Adherence to Web-based therapies is often poor. One way to increase this is to create a new health service role of a coach to guide people through the therapy. This study aimed to test in people referred to secondary care with depression if a Web-based therapy (The Journal) supported by a coach plus usual care would be more effective in reducing depression compared with usual care plus an information leaflet about Web-based resources after 12 weeks. We conducted a randomized controlled trial with two parallel arms and a process evaluation that included structured qualitative interviews analyzed using thematic analysis. The coach had a background in occupational therapy. Participants were recruited face-to-face at community mental health centers. We recruited 63 people into the trial (intervention 35, control 28). There were no statistically significant differences in the change from baseline in Patient Health Questionnaire-9 (PHQ-9) scores at 12 weeks comparing The Journal with usual care (mean change in PHQ-9 score 9.4 in the intervention group and 7.1 in the control group, t 41 =1.05, P=.30; mean difference=2.3, 95% CI -2.1 to 6.7). People who were offered The Journal attended on average about one less outpatient appointment compared with usual care, although this difference was not statistically significant (intervention mean number of visits 2.8 (SD 5.5) compared with 4.1 (SD 6.7) in the control group, t 45 =-0.80, P=.43; mean difference=1.3, 95% CI -4.5 to 2.0). The process evaluation found that the mean number of lessons completed in the intervention group was 2.5 (SD=1.9; range=0-6) and the number of contacts with the coach was a mean of 8.1 (SD=4.4; range=0-17). The qualitative interviews highlighted the problem of engaging

Supportive treatment with megestrol acetate during radio-(chemo-)therapy. A randomized trial

International Nuclear Information System (INIS)

Fietkau, R.; Sauer, R.

1996-01-01

Background: The value of megestrol acetate in treating tumor anorexia and cachexia of terminal patients is well known. However, the supportive effect of megestrol acetate during intensive radio-(chemo-)therapy was not investigated up to now. Therefore a randomized trial was performed including patients with advanced tumors in the head and neck region. Patients and Methods: From June 1991 to December 1993 a total of 64 patients were admitted to a randomized, double-blind placebo-controlled study. During and up to 6 weeks following radiotherapy patients received 160 mg/d megestrol acetate or placebo. The nutritional status (anthropometric and laboratory parameters) and the quality-of-life index according to Padilla et al. were determined prior to therapy, 1, 4, 6 weeks later during radiotherapy and 12, 18 weeks after completion. Results: Sixty-one out of 64 patients were evaluable (control group: n=30; megestrol acetate patients: n=31). One patients refused further participation after randomization. One patient in each arm was excluded due to side effects (impotence, diarrhoea). Further side effects were not observed. In the control group the nutrititional parameters (body weight, triceps skinfold) and the subjective feeling of the patients deteriorated during radiotherapy and did not restore following radiotherapy. By contrast, the patients of the megestrol acetate group were able to stabilize these parameters. This difference was most prominent in the orally nourished patients (weight loss during therapy: Control group: -4.1 kg; megestrol acetate group: -0.8 kg; p=0.004); but not in the patients fed by percutaneous endoscopically guided gastrostomy (weight loss control group: -2.4 kg; megestrol acetate group: -0.8 kg; p=0.14). Conclusion: In patients on radiochemotherapy megestrol acetate prevents patients from further deterioration of the nutritional status and quality of life. (orig.) [de

[Challenges in the organization of investigator initiated trials: in transplantation medicine].

Science.gov (United States)

Schnitzbauer, A A; Lamby, P E; Mutzbauer, I; von Hassel, J; Geissler, E K; Schlitt, H J

2011-03-01

Transplantation medicine offers multiple translational questions which should preferably be transferred to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific approach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product. We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach. Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry. Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.

Microrandomized trials: An experimental design for developing just-in-time adaptive interventions.

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Klasnja, Predrag; Hekler, Eric B; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A

2015-12-01

This article presents an experimental design, the microrandomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals' health behaviors. Microrandomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. The article describes the microrandomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Microrandomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Microrandomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions' effects, enabling creation of more effective JITAIs. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Systems of support to increase colorectal cancer screening and follow-up rates (SOS): design, challenges, and baseline characteristics of trial participants.

Science.gov (United States)

Green, Beverly B; Wang, C Y; Horner, Kathryn; Catz, Sheryl; Meenan, Richard T; Vernon, Sally W; Carrell, David; Chubak, Jessica; Ko, Cynthia; Laing, Sharon; Bogart, Andy

2010-11-01

Screening decreases colorectal cancer (CRC) morbidity and mortality, yet remains underutilized. Screening breakdowns arise from lack of uptake and failure to follow-up after a positive screening test. Systems of support to increase colorectal cancer screening and follow-up (SOS) is a randomized trial designed to increase: (1) CRC screening and (2) follow-up of positive screening tests. The Chronic Care Model and the Preventive Health Model inform study design. The setting is a large nonprofit healthcare organization. In part-1 study, patients age 50-75 due for CRC screening are randomized to one of 4 study conditions. Arm 1 receives usual care. Arm 2 receives automated support (mailed information about screening choices and fecal occult blood tests (FOBT)). Arm 3 receives automated and assisted support (a medical assistant telephone call). Arm 4 receives automated, assisted, and care management support (a registered nurse provides behavioral activation and coordination of care). In part-2, study patients with a positive FOBT or adenomas on flexible sigmoidoscopy are randomized to receive either usual care or nurse care management. Primary outcomes are: 1) the proportion with CRC screening, 2) the proportion with a complete diagnostic evaluation after a positive screening test. We sent recruitment letters to 15,414 patients and 4675 were randomized. Randomly assigned treatment groups were similar in age, sex, race, education, self-reported health, and CRC screening history. We will determine the effectiveness and cost effectiveness of stepped increases in systems of support to increase CRC screening and follow-up after a positive screening test over 2years. Copyright © 2010 Elsevier Inc. All rights reserved.

Patient representatives' views on patient information in clinical cancer trials

DEFF Research Database (Denmark)

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-01-01

of future simplified and more attractive informed consent forms. CONCLUSIONS: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language......BACKGROUND: Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed...... consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. METHODS: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I...

Parenting program versus telephone support for Mexican parents of children with acquired brain injury: A blind randomized controlled trial.

Science.gov (United States)

Chávez, Clara; Catroppa, Cathy; Hearps, Stephen J C; Yáñez-Téllez, Guillermina; Prieto-Corona, Belén; de León, Miguel A; García, Antonio; Sandoval-Lira, Lucero; Anderson, Vicki

2017-09-01

Acquired brain injury (ABI) during childhood typically causes behavior problems in the child and high levels of stress in the family. The aims of this study are: (1) to investigate the effectiveness and feasibility of a parenting intervention in improving behavior and self-regulation in Mexican children with ABI compared to telephone support; (2) to investigate the effectiveness and feasibility of a parenting intervention in improving parenting skills, parent self-efficacy and decreasing parental stress in parents of children with ABI compared to telephone support. Our secondary aims are (1) to explore the impact that parent characteristics have on the intervention outcomes; (2) to investigate if changes are maintained 3 months after the intervention. The research design is a blind randomized controlled trial (RCT). Eligible participants include children with a diagnosis of ABI, between 6 and 12 years of age, and their parents. Sixty-six children and their parents will be randomly allocated to either a parenting program group or telephone support group. The parenting program involves six face-to-face weekly group sessions of 2.5 h each. Participants in the control group receive an information sheet with behavioral strategies, and six weekly phone calls, in which strategies to improve academic skills are provided. Children and their parents are evaluated by blind assessors before the intervention, immediately after the intervention and 3-months post-intervention. This study will be the first to evaluate the efficacy and feasibility of a parenting program for Mexican parents of children with ABI. ACTRN12617000360314.

Cognitive Behavioral Therapy versus Short Psychodynamic Supportive Psychotherapy in the outpatient treatment of depression: a randomized controlled trial

Directory of Open Access Journals (Sweden)

Kool Simone

2007-10-01

-effectiveness. Clinical predictors of treatment outcome include demographic variables, psychiatric symptoms, cognitive and psychological patient characteristics and the quality of the therapeutic relationship. Discussion This study evaluates Short Psychodynamic Supportive Psychotherapy as a treatment for depressed outpatients by comparing it to the established evidence-based treatment Cognitive Behavioral Therapy. Specific strengths of this study include its strong external validity and the clinical relevance of its research aims. Limitations of the study are discussed. Trial registration Current Controlled Trails ISRCTN31263312

The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial.

Science.gov (United States)

Mbuagbaw, Lawrence; Thabane, Lehana; Ongolo-Zogo, Pierre; Lang, Trudie

2011-06-09

Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process.

The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS trial, an investigator initiated trial

Directory of Open Access Journals (Sweden)

Ongolo-Zogo Pierre

2011-06-01

Full Text Available Abstract Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process.

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

Science.gov (United States)

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

Pantomime-grasping: Advance knowledge of haptic feedback availability supports an absolute visuo-haptic calibration

Directory of Open Access Journals (Sweden)

Shirin eDavarpanah Jazi

2016-05-01

Full Text Available An emerging issue in movement neurosciences is whether haptic feedback influences the nature of the information supporting a simulated grasping response (i.e., pantomime-grasping. In particular, recent work by our group contrasted pantomime-grasping responses performed with (i.e., PH+ trials and without (i.e., PH- trials terminal haptic feedback in separate blocks of trials. Results showed that PH- trials were mediated via relative visual information. In contrast, PH+ trials showed evidence of an absolute visuo-haptic calibration – a finding attributed to an error signal derived from a comparison between expected and actual haptic feedback (i.e., an internal forward model. The present study examined whether advanced knowledge of haptic feedback availability influences the aforementioned calibration process. To that end, PH- and PH+ trials were completed in separate blocks (i.e., the feedback schedule used in our group’s previous study and a block wherein PH- and PH+ trials were randomly interleaved on a trial-by-trial basis (i.e., random feedback schedule. In other words, the random feedback schedule precluded participants from predicting whether haptic feedback would be available at the movement goal location. We computed just-noticeable-difference (JND values to determine whether responses adhered to, or violated, the relative psychophysical principles of Weber’s law. Results for the blocked feedback schedule replicated our group’s previous work, whereas in the random feedback schedule PH- and PH+ trials were supported via relative visual information. Accordingly, we propose that a priori knowledge of haptic feedback is necessary to support an absolute visuo-haptic calibration. Moreover, our results demonstrate that the presence and expectancy of haptic feedback is an important consideration in contrasting the behavioral and neural properties of natural and stimulated (i.e., pantomime-grasping grasping.

Interventions for supporting pregnant women's decision-making about mode of birth after a caesarean.

Science.gov (United States)

Horey, Dell; Kealy, Michelle; Davey, Mary-Ann; Small, Rhonda; Crowther, Caroline A

2013-07-30

Pregnant women who have previously had a caesarean birth and who have no contraindication for vaginal birth after caesarean (VBAC) may need to decide whether to choose between a repeat caesarean birth or to commence labour with the intention of achieving a VBAC. Women need information about their options and interventions designed to support decision-making may be helpful. Decision support interventions can be implemented independently, or shared with health professionals during clinical encounters or used in mediated social encounters with others, such as telephone decision coaching services. Decision support interventions can include decision aids, one-on-one counselling, group information or support sessions and decision protocols or algorithms. This review considers any decision support intervention for pregnant women making birth choices after a previous caesarean birth. To examine the effectiveness of interventions to support decision-making about vaginal birth after a caesarean birth.Secondary objectives are to identify issues related to the acceptability of any interventions to parents and the feasibility of their implementation. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2013), Current Controlled Trials (22 July 2013), the WHO International Clinical Trials Registry Platform Search Portal (ICTRP) (22 July 2013) and reference lists of retrieved articles. We also conducted citation searches of included studies to identify possible concurrent qualitative studies. All published, unpublished, and ongoing randomised controlled trials (RCTs) and quasi-randomised trials with reported data of any intervention designed to support pregnant women who have previously had a caesarean birth make decisions about their options for birth. Studies using a cluster-randomised design were eligible for inclusion but none were identified. Studies using a cross-over design were not eligible for inclusion. Studies published in abstract form

Bar versus ball attachments for implant-supported overdentures in complete edentulism: A systematic review.

Science.gov (United States)

Anas El-Wegoud, Marwah; Fayyad, Ahmed; Kaddah, Amal; Nabhan, Ashraf

2018-04-01

Implant-supported overdenture is one of the most predictable treatment options used in complete edentulism. However, differences have been reported between bar and ball attachments used to retain overdentures in terms of patient satisfaction and prosthesis retention. The purpose of this study is to compare the effectiveness of bar and ball attachments for conventionally loaded implant-supported overdentures in completely edentulous patients to improve patient satisfaction and prosthesis retention. We conducted the review according to the Cochrane methods and following MECIR standards. We searched Cochrane Oral Health Group Trial register, Cochrane Central Register of Controlled Trials, MEDLINE, and the WHO ICTRP (March 31, 2017). Two review authors assessed trials for inclusion and risk of bias, extracted data, and checked for accuracy. We have expressed results as risk ratio or mean differences, together with their 95% confidence intervals. We included 10 trials (465 participants). After 5 y, one trial reported higher patient satisfaction when bar attachment was used (MD 1.30, 95% CI 0.20-2.40), and reported no difference between both systems in prosthesis retention (MD -0.90, 95% CI -1.90 to 0.10). Two trials reported no implant failures after 1 and 5 y in both attachments. Downgrading of evidence was based on the unclear risk of bias of included studies and the wide CI crossing the line of no effect. There is insufficient evidence to support bar or ball attachment to be used with implant-supported overdentures in completely edentulous patients to improve patient satisfaction and prosthesis retention (PROSPERO 2014:CRD42014014594). © 2017 Wiley Periodicals, Inc.

Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting children's early self-regulation development: study protocol for a cluster randomized controlled trial.

Science.gov (United States)

Howard, Steven J; Vasseleu, Elena; Neilsen-Hewett, Cathrine; Cliff, Ken

2018-01-24

For children with low self-regulation in the preschool years, the likelihood of poorer intellectual, health, wealth and anti-social outcomes in adulthood is overwhelming. Yet this knowledge has not yielded a framework for understanding self-regulatory change, nor generated particularly successful methods for enacting this change. Reconciling insights from cross-disciplinary theory, research and practice, this study seeks to implement a newly developed program of low-cost and routine practices and activities for supporting early self-regulatory development within preschool contexts and to evaluate its effect on children's self-regulation, executive function and school readiness; and educator perceived knowledge, attitudes and self-efficacy related to self-regulation. The Early Start to Self-Regulation study is a cluster randomized, controlled trial for evaluating benefits of the Preschool Situational Self-Regulation Toolkit (PRSIST) program, when implemented by early childhood educators, compared with routine practice. The PRSIST program combines professional learning, adult practices, child activities and connections to the home to support children's self-regulation development. Fifty preschool centers in New South Wales, Australia, will be selected to ensure a range of characteristics, namely: National Quality Standards (NQS) ratings, geographic location and socioeconomic status. After collection of baseline child and educator data, participating centers will then be randomly allocated to one of two groups, stratified by NQS rating: (1) an intervention group (25 centers) that will implement the PRSIST program; or (2) a control group (25 centers) that will continue to engage in practice as usual. Primary outcomes at the child level will be two measures of self-regulation: Head-Toes-Knees-Shoulders task and the PRSIST observational assessment. Secondary outcomes at the child level will be adult-reported measures of child self-regulation, executive function and

Couple-Based Psychosexual Support Following Prostate Cancer Surgery: Results of a Feasibility Pilot Randomized Control Trial.

Science.gov (United States)

Robertson, Jane; McNamee, Phillip; Molloy, Gerry; Hubbard, Gill; McNeill, Alan; Bollina, Prasad; Kelly, Daniel; Forbat, Liz

2016-08-01

Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this

Masticatory function with implant-supported overdentures

NARCIS (Netherlands)

van Kampen, FMC; van der Bilt, A; Cune, MS; Fontijn-Tekamp, FA; Bosman, F

The type of attachment that is used in implant-supported mandibular overdentures may influence the retention and stability of the prosthesis and, thus, masticatory function. In this within- subject cross- over clinical trial, we examined the hypothesis that greater retention and stability of the

Versicherung und volkswirtschaftlicher Kreislauf

OpenAIRE

Lampert, Heinz

1982-01-01

Versicherung und volkswirtschaftlicher Kreislauf : zur Behandlung d. Privatversicherung in d. volkswirtschaftl. Gesamtrechnung. - In: Zeitschrift für die gesamte Versicherungswissenschaft. 71. 1982. S. 189-210

Comparing topical hydrocortisone cream with Hai's Perianal Support in managing symptomatic hemorrhoids in pregnancy: a preliminary trial.

Science.gov (United States)

Lim, Soo Soo; Yu, Chye Wah; Aw, Lin Da

2015-02-01

The prevalence of hemorrhoids among pregnant women is high in late pregnancy. This study was to evaluate the efficacy between drug treatment with Procort (topical hydrocortisone cream 1%) and mechanical treatment with a Hai's Perianal Support (HPS) toilet seat device in managing symptomatic hemorrhoids during the third trimester of pregnancy. A prospective randomized controlled study was conducted on 23 pregnant women with gestation above the 28th week and presented with symptomatic hemorrhoids. Pre- and post-interventional assessment was carried out to obtain data on symptoms of pain, itching, swelling, discomfort and bleeding associated with hemorrhoids. The control group was treated with topical hydrocortisone cream 1% and the test group was provided and taught to use a HPS, a posterior perineal support toilet seat device (Colorec). The results showed improvement in symptoms of pain, swelling, bleeding, itching and discomfort in both the test and control groups. However, statistically significant differences were found on symptoms of pain, swelling and discomfort between the test and control groups. There was also a statistically significant difference in well-being and overall improvement between the test and control groups. HPS has to a certain extent significantly reduced the symptoms of hemorrhoids in pregnancy and improved the well-being of pregnant women in comparison with topical treatment with hydrocortisone cream. However, more clinical trials need to be carried out to recomfirm the role of HPS in hemorrhoids in pregnancy. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

A randomized controlled trial of a modified wheelchair arm-support to reduce shoulder pain in stroke patients.

Science.gov (United States)

Pan, Ruihuan; Zhou, Mingchao; Cai, Hao; Guo, Youhua; Zhan, Lechang; Li, Mei; Yang, Zhijing; Zhu, Leying; Zhan, Jie; Chen, Hongxia

2018-01-01

To evaluate the effect of modified wheelchair arm-support to mitigate hemiplegic shoulder pain and reduce pain frequency in stroke patients. A single-blind randomized controlled trial using computer-generated simple randomization. Participants recruited from inpatients at the Guangdong Provincial Hospital of Chinese Medicine. A total of 120 patients with stroke were divided into two groups. All subjects underwent basic rehabilitation training and wheelchair assistance with eight weeks follow-up period. Patients in the treatment group additionally received modified wheelchair arm-support for at least 60 minutes a day, six days a week, for four weeks. Primary outcome was measured by the Visual Analogue Pain Scale or Numeric Pain Rating Scale. Secondary outcome was measured using the Upper Extremity Fugl-Meyer Assessment scale, Modified Barthel Index and Quality of Life Index. Measurements were made at 4 weeks and 12 weeks, following the intervention. Patients age from 21 to 83 years (mean ± SD = 62.41 ± 12.26). The average duration of disease was 1.9 ± 1.3 months. At four weeks, the median of pain intensity was higher in the control group (median, interquartile range = 3, 5.75 vs. 2, 3.75; P = 0.059). At 12 weeks, the median of pain intensity was higher in the control group (median, interquartile range = 3, 5.00 vs. 0, 1.00; P vs. 1; P stroke patients. It may also improve the patients' quality of life.

Nutritional support in chronic obstructive pulmonary disease: a systematic review and meta-analysis.

Science.gov (United States)

Collins, Peter F; Stratton, Rebecca J; Elia, Marinos

2012-06-01

The efficacy of nutritional support in the management of malnutrition in chronic obstructive pulmonary disease (COPD) is controversial. Previous meta-analyses, based on only cross-sectional analysis at the end of intervention trials, found no evidence of improved outcomes. The objective was to conduct a meta-analysis of randomized controlled trials (RCTs) to clarify the efficacy of nutritional support in improving intake, anthropometric measures, and grip strength in stable COPD. Literature databases were searched to identify RCTs comparing nutritional support with controls in stable COPD. Thirteen RCTs (n = 439) of nutritional support [dietary advice (1 RCT), oral nutritional supplements (ONS; 11 RCTs), and enteral tube feeding (1 RCT)] with a control comparison were identified. An analysis of the changes induced by nutritional support and those obtained only at the end of the intervention showed significantly greater increases in mean total protein and energy intakes with nutritional support of 14.8 g and 236 kcal daily. Meta-analyses also showed greater mean (±SE) improvements in favor of nutritional support for body weight (1.94 ± 0.26 kg, P groups. This systematic review and meta-analysis showed that nutritional support, mainly in the form of ONS, improves total intake, anthropometric measures, and grip strength in COPD. These results contrast with the results of previous analyses that were based on only cross-sectional measures at the end of intervention trials.

A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol.

Science.gov (United States)

Mastellos, Nikolaos; Andreasson, Anna; Huckvale, Kit; Larsen, Mark; Curcin, Vasa; Car, Josip; Agreus, Lars; Delaney, Brendan

2015-02-03

Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. EudraCT: 2014-001314-25.

An organisational change intervention for increasing the delivery of smoking cessation support in addiction treatment centres: study protocol for a randomized controlled trial.

Science.gov (United States)

Bonevski, Billie; Guillaumier, Ashleigh; Shakeshaft, Anthony; Farrell, Michael; Tzelepis, Flora; Walsberger, Scott; D'Este, Catherine; Paul, Chris; Dunlop, Adrian; Searles, Andrew; Kelly, Peter; Fry, Rae; Stirling, Robert; Fowlie, Carrie; Skelton, Eliza

2016-06-14

The provision of smoking cessation support in Australian drug and alcohol treatment services is sub-optimal. This study examines the cost-effectiveness of an organisational change intervention to reduce smoking amongst clients attending drug and alcohol treatment services. A cluster-randomised controlled trial will be conducted with drug and alcohol treatment centres as the unit of randomisation. Biochemically verified (carbon monoxide by breath analysis) client 7-day-point prevalence of smoking cessation at 6 weeks will be the primary outcome measure. The study will be conducted in 33 drug and alcohol treatment services in four mainland states and territories of Australia: New South Wales, Australian Capital Territory, Queensland, and South Australia. Eligible services are those with ongoing client contact and that include pharmacotherapy services, withdrawal management services, residential rehabilitation, counselling services, and case management services. Eligible clients are those aged over 16 years who are attending their first of a number of expected visits, are self-reported current smokers, proficient in the English language, and do not have severe untreated mental illness as identified by the service staff. Control services will continue to provide usual care to the clients. Intervention group services will receive an organisational change intervention, including assistance in developing smoke-free policies, nomination of champions, staff training and educational client and service resources, and free nicotine replacement therapy in order to integrate smoking cessation support as part of usual client care. If effective, the organisational change intervention has clear potential for implementation as part of the standard care in drug and alcohol treatment centres. Australian and New Zealand Clinical Trials Registry, ACTRN12615000204549 . Registered on 3 March 2015.

Efficacy of a Micro-Prompting Technology in Reducing Support Needed by People With Severe Acquired Brain Injury in Activities of Daily Living: A Randomized Control Trial.

Science.gov (United States)

OʼNeill, Brian; Best, Catherine; OʼNeill, Lauren; Ramos, Sara D S; Gillespie, Alex

2017-11-29

To evaluate the effectiveness of an automated interactive prompting technology in supporting the morning routine of persons with acquired brain injury. The morning routine included maintaining personal hygiene and dressing. An inpatient neurorehabilitation hospital. Persons with acquired brain injury who required prompting when following their morning routine (n = 24), but were not limited by physical disability or dysphasia, took part in the study. Participants (67% with traumatic brain injury) had impairment on indices of memory and executive function. A randomized control trial evaluated the effect of an automated interactive micro-prompting device on the number of prompts by trained staff required for successful completion of the morning routine. Study-specific checklists assessed sequence performance, errors, and verbal prompts required over baseline, rehabilitation as usual, intervention, and return to baseline conditions. The intervention significantly reduced the support required to complete the task compared with usual rehabilitation. Micro-prompting technology is an effective assistive technology for cognition, which reduces support needs in people with significant cognitive impairments.

Short-term effects of customized arch support insoles on symptomatic flexible flatfoot in children: A randomized controlled trial.

Science.gov (United States)

Hsieh, Ru-Lan; Peng, Hui-Ling; Lee, Wen-Chung

2018-05-01

Limited evidence is available regarding the effects of insoles on pediatric flexible flatfoot because of the heterogeneity and low methodological quality of previous studies. The purpose of this prospective trial is to examine the short-term effects of customized arch support insoles on symptomatic flexible flatfoot in children by using the International Classification of Functioning, randomized controlled Disability, and Health (ICF) framework. This study was conducted in a rehabilitation outpatient clinic of a teaching hospital. Fifty-two children with symptomatic flexible flatfoot were included. The children in the treatment group wore customized arch support insoles for 12 weeks, whereas those in the control group did not wear the insoles. Both clinical and radiographic measurements, including the navicular drop, foot posture index, Beighton hypermobility score, talonavicular coverage angle, calcaneal inclination angle, and calcaneal-first metatarsal angle, were used for diagnosing flexible flatfoot. Physical activity (10-m normal and fast walking, stair ascent, stair descent, and chair rising), physical function, and psychometric properties (Pediatric Outcome Data Collection Instrument and Pediatric Quality of Life Inventory) were evaluated at the baseline and 12 weeks after the intervention. Compared with the control group, the treatment group exhibited significant improvement in pain/comfort (P = .048), physical health (P = .035), stair ascent time (P = .015), upper extremity and physical function (P = .016), and transfer and basic mobility (P = .042) during the intervention period. Children with flexible flatfoot who wore customized arch support insoles for 12 weeks exhibited significantly improved pain/comfort, physical health, stair ascent time, upper extremity and physical function, and transfer and basic mobility. These variables belong to the domains of body functions and structures and activity and participation in the ICF

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial.

Science.gov (United States)

Rushing, J; Wing, R; Wadden, T A; Knowler, W C; Lawlor, M; Evans, M; Killean, T; Montez, M; Espeland, M A; Zhang, P

2017-03-01

The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost-effectiveness of the ILI and will contain additional follow-up data.

‘The phone reminder is important, but will others get to know about my illness?’ Patient perceptions of an mHealth antiretroviral treatment support intervention in the HIVIND trial in South India

Science.gov (United States)

Rodrigues, Rashmi; Poongulali, S; Balaji, Kavitha; Atkins, Salla; Ashorn, Per; De Costa, Ayesha

2015-01-01

Objectives The recent explosion of mHealth applications in the area of HIV care has led to the development of mHealth interventions to support antiretroviral treatment adherence. Several of these interventions have been tested for effectiveness, but few studies have explored patient perspectives of such interventions. Exploring patient perspectives enhances the understanding of how an intervention works or why it does not. We therefore studied perceptions regarding an mHealth adherence intervention within the HIVIND trial in South India. Methods The study was conducted at three clinics in South India. The intervention comprised an automated interactive voice response (IVR) call and a pictorial short messaging service (SMS), each delivered weekly. Sixteen purposively selected participants from the intervention arm in the HIVIND trial were interviewed. All participants had completed at least 84 weeks since enrollment in the trial. Perceptions on the usefulness and perceived benefits and risks of receiving the intervention were sought. The interviews were transcribed and analysed using the framework approach to qualitative data analysis. Results Despite varying perceptions of the intervention, most participants found it useful. The intervention was perceived as a sign of ‘care’ from the clinic. The IVR call was preferred to the SMS reminder. Two-way communication was preferred to automated calls. Participants also perceived a risk of unintentional disclosure of their HIV status and stigma thereof via the intervention and took initiatives to mitigate this risk. Targeting reminders at those with poor adherence and those in need of social support was suggested. Conclusions mHealth adherence interventions go beyond their intended role to provide a sense of care and support to the recipient. Although automated interventions are impersonal, they could be a solution for scale up. Interventions that engage both the recipient and the healthcare provider have greater

A qualitative exploration of trial-related terminology in a study involving Deaf British Sign Language users.

Science.gov (United States)

Young, Alys; Oram, Rosemary; Dodds, Claire; Nassimi-Green, Catherine; Belk, Rachel; Rogers, Katherine; Davies, Linda; Lovell, Karina

2016-04-27

Internationally, few clinical trials have involved Deaf people who use a signed language and none have involved BSL (British Sign Language) users. Appropriate terminology in BSL for key concepts in clinical trials that are relevant to recruitment and participant information materials, to support informed consent, do not exist. Barriers to conceptual understanding of trial participation and sources of misunderstanding relevant to the Deaf community are undocumented. A qualitative, community participatory exploration of trial terminology including conceptual understanding of 'randomisation', 'trial', 'informed choice' and 'consent' was facilitated in BSL involving 19 participants in five focus groups. Data were video-recorded and analysed in source language (BSL) using a phenomenological approach. Six necessary conditions for developing trial information to support comprehension were identified. These included: developing appropriate expressions and terminology from a community basis, rather than testing out previously derived translations from a different language; paying attention to language-specific features which support best means of expression (in the case of BSL expectations of specificity, verb directionality, handshape); bilingual influences on comprehension; deliberate orientation of information to avoid misunderstanding not just to promote accessibility; sensitivity to barriers to discussion about intelligibility of information that are cultural and social in origin, rather than linguistic; the importance of using contemporary language-in-use, rather than jargon-free or plain language, to support meaningful understanding. The study reinforces the ethical imperative to ensure trial participants who are Deaf are provided with optimum resources to understand the implications of participation and to make an informed choice. Results are relevant to the development of trial information in other signed languages as well as in spoken/written languages when

The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database

Science.gov (United States)

Chen, Yu-Pei; Lv, Jia-Wei; Liu, Xu; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

2017-01-01

In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials. PMID:28042342

Strategies to improve recruitment to randomised trials.

Science.gov (United States)

Treweek, Shaun; Pitkethly, Marie; Cook, Jonathan; Fraser, Cynthia; Mitchell, Elizabeth; Sullivan, Frank; Jackson, Catherine; Taskila, Tyna K; Gardner, Heidi

2018-02-22

health care.We found 72 comparisons, but just three are supported by high-certainty evidence according to GRADE.1. Open trials rather than blinded, placebo trials. The absolute improvement was 10% (95% CI 7% to 13%).2. Telephone reminders to people who do not respond to a postal invitation. The absolute improvement was 6% (95% CI 3% to 9%). This result applies to trials that have low underlying recruitment. We are less certain for trials that start out with moderately good recruitment (i.e. over 10%).3. Using a particular, bespoke, user-testing approach to develop participant information leaflets. This method involved spending a lot of time working with the target population for recruitment to decide on the content, format and appearance of the participant information leaflet. This made little or no difference to recruitment: absolute improvement was 1% (95% CI -1% to 3%).We had moderate-certainty evidence for eight other comparisons; our confidence was reduced for most of these because the results came from a single study. Three of the methods were changes to trial management, three were changes to how potential participants received information, one was aimed at recruiters, and the last was a test of financial incentives. All of these comparisons would benefit from other researchers replicating the evaluation. There were no evaluations in paediatric trials.We had much less confidence in the other 61 comparisons because the studies had design flaws, were single studies, had very uncertain results or were hypothetical (mock) trials rather than real ones. The literature on interventions to improve recruitment to trials has plenty of variety but little depth. Only 3 of 72 comparisons are supported by high-certainty evidence according to GRADE: having an open trial and using telephone reminders to non-responders to postal interventions both increase recruitment; a specialised way of developing participant information leaflets had little or no effect. The methodology

A pilot cluster randomised controlled trial of a support and training intervention to improve the mental health of secondary school teachers and students - the WISE (Wellbeing in Secondary Education) study.

Science.gov (United States)

Kidger, Judi; Stone, Tracey; Tilling, Kate; Brockman, Rowan; Campbell, Rona; Ford, Tamsin; Hollingworth, William; King, Michael; Araya, Ricardo; Gunnell, David

2016-10-06

Secondary school teachers are at heightened risk of psychological distress, which can lead to poor work performance, poor quality teacher-student relationships and mental illness. A pilot cluster randomised controlled trial (RCT) - the WISE study - evaluated the feasibility of a full-scale RCT of an intervention to support school staff's own mental health, and train them in supporting student mental health. Six schools were randomised to an intervention or control group. In the intervention schools i) 8-9 staff received Mental Health First Aid (MHFA) training and became staff peer supporters, and ii) youth MHFA training was offered to the wider staff body. Control schools continued with usual practice. We used thematic qualitative data analysis and regression modelling to ascertain the feasibility, acceptability and potential usefulness of the intervention. Thirteen training observations, 14 staff focus groups and 6 staff interviews were completed, and 438 staff (43.5 %) and 1,862 (56.3 %) students (years 8 and 9) completed questionnaires at baseline and one year later. MHFA training was considered relevant for schools, and trainees gained in knowledge, confidence in helping others, and awareness regarding their own mental health. Suggestions for reducing the length of the training and focusing on helping strategies were made. A peer support service was established in all intervention schools and was perceived to be helpful in supporting individuals in difficulty - for example through listening, and signposting to other services - and raising the profile of mental health at a whole school level. Barriers to use included lack of knowledge about the service, concerns about confidentiality and a preference for accessing support from pre-existing networks. The WISE intervention is feasible and acceptable to schools. Results support the development of a full-scale cluster RCT, if steps are taken to improve response rates and implement the suggested improvements to the

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

Science.gov (United States)

Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

2015-03-15

Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

Sodium Restriction in Patients With CKD : A Randomized Controlled Trial of Self-management Support

NARCIS (Netherlands)

Meuleman, Yvette; Hoekstra, Tiny; Dekker, Friedo W.; Navis, Gerjan; Vogt, Liffert; van der Boog, Paul J. M.; Bos, Willem Jan W.; van Montfrans, Gert A.; van Dijk, Sandra

Background: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. Study Design: Open randomized controlled trial. Setting & Participants: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands.

Operating experience with innovative environmental technologies; Betriebserfahrungen mit innovativen Umwelttechnologien

Energy Technology Data Exchange (ETDEWEB)

Spindler, H.; Bauermeister, U.; Kliche, H.; Seiffarth, K. (comps.)

2000-03-01

The MUT '99 (Merseburger Umwelt-Tag) discussed modern processes, technologies and plants for treatment and utilisation of waste. The conference was attended by industrial organisations and scientific institutions. [German] Der 9. Merseburger Umwelt-Tag MUT '99 steht unter dem Motto 'Betriebserfahrungen mit innovativen Umwelttechnologien - Moderne wirtschaftliche Verfahren, Technologien und Anlagen zur Behandlung/Verwertung nichtvermeidbaren Abfalls', wobei der Begriff 'Abfall' sich letztlich auf alle Umweltmedien bezieht. Entsprechend dem Motto dieser Tagung stellen Unternehmen, Betriebe und wissenschaftliche Einrichtungen ihre Erfahrungen auf dem Gebiet der Umwelttechnologien vor, um Entwicklungen auf diesem Gebiet einer breiten Diskussion zu eroeffnen. Dabei soll es insbesondere um die Behandlung nicht vermeidbarer Abfaelle und Abwaesser gehen. (orig.)

Evaluation of a transdiagnostic psychodynamic online intervention to support return to work: A randomized controlled trial.

Directory of Open Access Journals (Sweden)

Rüdiger Zwerenz

Full Text Available Given their flexibility, online interventions may be useful as an outpatient treatment option to support vocational reintegration after inpatient rehabilitation. To that purpose we devised a transdiagnostic psychodynamic online intervention to facilitate return to work, focusing on interpersonal conflicts at the workplace often responsible for work-related stress.In a randomized controlled trial, we included employed patients from cardiologic, psychosomatic and orthopedic rehabilitation with work-related stress or need for support at intake to inpatient rehabilitation after they had given written consent to take part in the study. Following discharge, maladaptive interpersonal interactions at the workplace were identified via weekly blogs and processed by written therapeutic comments over 12 weeks in the intervention group (IG. The control group (CG received an augmented treatment as usual condition. The main outcome, subjective prognosis of gainful employment (SPE, and secondary outcomes (psychological complaints were assessed by means of online questionnaires before, at the end of aftercare (3 months and at follow-up (12 months. We used ITT analyses controlling for baseline scores and medical group.N = 319 patients were enrolled into IG and N = 345 into CG. 77% of the IG logged in to the webpage (CG 74% and 65% of the IG wrote blogs. Compared to the CG, the IG reported a significantly more positive SPE at follow-up. Measures of depression, anxiety and psychosocial stressors decreased from baseline to follow-up, whereas the corresponding scores increased in the CG. Correspondingly, somatization and psychological quality of life improved in the IG.Psychodynamic online aftercare was effective to enhance subjective prognosis of future employment and improved psychological complaints across a variety of chronic physical and psychological conditions, albeit with small effect sizes.

Decision aids for people considering taking part in clinical trials.

Science.gov (United States)

Gillies, Katie; Cotton, Seonaidh C; Brehaut, Jamie C; Politi, Mary C; Skea, Zoe

2015-11-27

Several interventions have been developed to promote informed consent for participants in clinical trials. However, many of these interventions focus on the content and structure of information (e.g. enhanced information or changes to the presentation format) rather than the process of decision making. Patient decision aids support a decision making process about medical options. Decision aids support the decision process by providing information about available options and their associated outcomes, alongside information that enables patients to consider what value they place on particular outcomes, and provide structured guidance on steps of decision making. They have been shown to be effective for treatment and screening decisions but evidence on their effectiveness in the context of informed consent for clinical trials has not been synthesised. To assess the effectiveness of decision aids for clinical trial informed consent compared to no intervention, standard information (i.e. usual practice) or an alternative intervention on the decision making process. We searched the following databases and to March 2015: Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library; MEDLINE (OvidSP) (from 1950); EMBASE (OvidSP) (from 1980); PsycINFO (OvidSP) (from 1806); ASSIA (ProQuest) (from 1987); WHO International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/); ClinicalTrials.gov; ISRCTN Register (http://www.controlled-trials.com/isrctn/). We also searched reference lists of included studies and relevant reviews. We contacted study authors and other experts. There were no language restrictions. We included randomised and quasi-randomised controlled trials comparing decision aids in the informed consent process for clinical trials alone, or in conjunction with standard information (such as written or verbal) or alongside alternative interventions (e.g. paper-based versus web-based decision aids). Included trials involved

Oral nutritional support can shorten the duration of parenteral hydration in end-of-life cancer patients: a randomized controlled trial.

Science.gov (United States)

Ishiki, Hiroto; Iwase, Satoru; Gyoda, Yasuaki; Kanai, Yoshiaki; Ariyoshi, Keisuke; Miyaji, Tempei; Tahara, Yukiko; Kawaguchi, Takashi; Chinzei, Mieko; Yamaguchi, Takuhiro

2015-01-01

Tube feeding or hydration is often considered for end-of-life cancer patients despite the negative effects on quality of life. The efficacy of oral nutritional support in this setting is unknown. We conducted a randomized trial to compare the efficacies of an amino acid jelly, Inner Power® (IP), and a liquid enteral product, Ensure Liquid® (EL), in terminally ill cancer patients. We randomly assigned patients to 3 arms: EL, IP, and EL+IP. The primary endpoint was drip infusion in vein (DIV)-free survival, which was defined as the duration from nutritional support initiation to administration of parenteral hydration. Twenty-seven patients were enrolled in the study, of whom 21 were included in the intention-to-treat analysis. The median age of the subjects was 69 yr. There were significant differences between the arms with regard to the median DIV-free survival (0.5, 6.0, and 4.5 days in the EL, IP, and EL + IP arms, respectively; P = 0.05). The median overall survival was 7, 9, and 8 days in the EL, IP, and EL + IP arms, respectively. IP may shorten the duration of parenteral hydration in terminally ill cancer patients and does not affect their survival.

Gym-based exercise was more costly compared with home-based exercise with telephone support when used as maintenance programs for adults with chronic health conditions: cost-effectiveness analysis of a randomised trial

Directory of Open Access Journals (Sweden)

Paul Jansons

2018-01-01

Registration: ACTRN12610001035011. [Jansons P, Robins L, O’Brien L, Haines T (2018 Gym-based exercise was more costly compared with home-based exercise with telephone support when used as maintenance programs for adults with chronic health conditions: cost-effectiveness analysis of a randomised trial. Journal of Physiotherapy 64: 48–54

Improving pneumonia case-management in Benin: a randomized trial of a multi-faceted intervention to support health worker adherence to Integrated Management of Childhood Illness guidelines

Directory of Open Access Journals (Sweden)

Lama Marcel

2009-08-01

Full Text Available Abstract Background Pneumonia is a leading cause of death among children under five years of age. The Integrated Management of Childhood Illness strategy can improve the quality of care for pneumonia and other common illnesses in developing countries, but adherence to these guidelines could be improved. We evaluated an intervention in Benin to support health worker adherence to the guidelines after training, focusing on pneumonia case management. Methods We conducted a randomized trial. After a health facility survey in 1999 to assess health care quality before Integrated Management of Childhood Illness training, health workers received training plus either study supports (job aids, non-financial incentives and supervision of workers and supervisors or "usual" supports. Follow-up surveys were conducted in 2001, 2002 and 2004. Outcomes were indicators of health care quality for Integrated Management-defined pneumonia. Further analyses included a graphical pathway analysis and multivariable logistic regression modelling to identify factors influencing case-management quality. Results We observed 301 consultations of children with non-severe pneumonia that were performed by 128 health workers in 88 public and private health facilities. Although outcomes improved in both intervention and control groups, we found no statistically significant difference between groups. However, training proceeded slowly, and low-quality care from untrained health workers diluted intervention effects. Per-protocol analyses suggested that health workers with training plus study supports performed better than those with training plus usual supports (20.4 and 19.2 percentage-point improvements for recommended treatment [p = 0.08] and "recommended or adequate" treatment [p = 0.01], respectively. Both groups tended to perform better than untrained health workers. Analyses of treatment errors revealed that incomplete assessment and difficulties processing clinical findings

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

Science.gov (United States)

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

Directory of Open Access Journals (Sweden)

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

The Online Parent Information and Support project, meeting parents' information and support needs for home-based management of childhood chronic kidney disease: research protocol.

Science.gov (United States)

Swallow, Veronica; Knafl, Kathleen; Sanatacroce, Sheila; Hall, Andrew; Smith, Trish; Campbell, Malcolm; Webb, Nicholas J A

2012-09-01

This article is a report of a protocol for studying the development and evaluation of an online parent information and support package for home-based care of children with chronic kidney disease stages 3-5. The study is funded by a National Institute of Health Research, Research for Patient Benefit Grant awarded (December 2010). Approval to undetake the study was obtained from the Department of Health National Research Ethics Service (June 2011). Children with chronic kidney disease require skilled, home-based care by parents, supported by professionals. Parents have identified a need for continuously available online resources to supplement professional support, and structured resources tailored to parents' needs are highlighted by policy makers as key to optimizing care; yet, online resource provision is patchy with little evidence base. Using mixed methods, we will (i) conduct parent/child/young person/professional/patient and parent volunteer focus groups to explore views on existing resources, (ii) collaboratively define gaps in provision, identify desirable components, develop/test resources and conduct a feasibility randomized controlled trial, and (iii) of usual professional support versus usual support supplemented by the package. Eighty parents of children with chronic kidney disease will be randomized. Primary outcomes will assess parents' self-efficacy and views of resources, using standardized measures at entry and 24 weeks, and semi-structured interviews at 24 weeks. We will finalize trial components for a later definitive trial. By working collaboratively, we will derive a detailed insight into parents' information and support needs and experiences of using the package, and should see improved parental self-efficacy. © 2012 Blackwell Publishing Ltd.

A Randomized Controlled Trial of 7-Day Intensive and Standard Weekly Cognitive Therapy for PTSD and Emotion-Focused Supportive Therapy

Science.gov (United States)

Ehlers, Anke; Hackmann, Ann; Grey, Nick; Wild, Jennifer; Liness, Sheena; Albert, Idit; Deale, Alicia; Stott, Richard; Clark, David M.

2014-01-01

Objective Psychological treatments for posttraumatic stress disorder (PTSD) are usually delivered once or twice weekly over several months. It is unclear whether they can be successfully delivered over a shorter period of time. This clinical trial had two goals, (1) to investigate the acceptability and efficacy of a 7-day intensive version of cognitive therapy for PTSD, and (2) to investigate whether cognitive therapy has specific treatment effects by comparing intensive and standard weekly cognitive therapy with an equally credible alternative treatment. Method Patients with chronic PTSD (N=121) were randomly allocated to 7-day intensive or standard 3-month weekly cognitive therapy for PTSD, 3-month weekly emotion-focused supportive therapy, or a 14-week waitlist condition. Primary outcomes were PTSD symptoms and diagnosis as assessed by independent assessors and self-report. Secondary outcomes were disability, anxiety, depression, and quality of life. Measures were taken at initial assessment, 6 weeks and 14 weeks (post-treatment/wait). For groups receiving treatment, measures were also taken at 3 weeks, and follow-ups at 27 and 40 weeks after randomization. All analyses were intent-to-treat. Results At post-treatment/wait assessment, 73%, 77%, 43%, 7% of the intensive cognitive therapy, standard cognitive therapy, supportive therapy, and waitlist groups, respectively, had recovered from PTSD. All treatments were well tolerated and were superior to waitlist on all outcome measures, with the exception of no difference between supportive therapy and waitlist on quality of life. For primary outcomes, disability and general anxiety, intensive and standard cognitive therapy were superior to supportive therapy. Intensive cognitive therapy achieved faster symptom reduction and comparable overall outcomes to standard cognitive therapy. Conclusions Cognitive therapy for PTSD delivered intensively over little more than a week is as effective as cognitive therapy delivered

Use of dexpanthenol and aloe vera to influence the irradiation response of the oral mucous membrane (mouse); Beeinflussung der Strahlenreaktion der Mundschleimhaut (Maus) durch Dexpanthenol {+-} Aloe vera

Energy Technology Data Exchange (ETDEWEB)

Schlichting, S. [Klinik und Poliklinik fuer Strahlentherapie und Radioonkologie, Dresden Univ. (Germany); Spekl, K.; Doerr, W. [Klinik und Poliklinik fuer Strahlentherapie und Radioonkologie, Dresden Univ. (Germany)]|[Experimentelles Zentrum, Medizinische Fakultaet Carl Gustav Carus, Dresden Univ. (Germany)

2004-07-01

In summarising the outcome of the present study it can be said spraying the agent on the oral mucous membrane once a day had an effect on the incidence of mucous membrane ulceration in the case of both placebo and dexpanthenol treatment. However, there was no significant difference between placebo and dexpanthenol treatment, the only finding being a slight prolongation of latency time through aloe vera. These experimental findings give good reason to critically reconsider the clinical use of dexpanthenol as a supportive treatment for the prevention of radiogenic mucositis enoralis following irradiation of tumours in the head and neck region. However thorough oral lavage is an effective means of moderating the irradiation response of the oral mucous membrane. [German] Zusammenfassend ist festzustellen, dass in den vorliegenden Versuchen mit einmal taeglichem Aufspruehen des Praeparates auf die Mundschleimhaut sowohl die Placebo - wie auch die Dexpanthenol-Behandlung die Inzidenz von Schleimhautulzerationen modifiziert hat; zwischen Placebo- und Dexpanthenol-Behandlung ergab sich jedoch kein signifikanter Unterschied. Lediglich eine geringe Verlaengerung der Latenzzeit durch Aloe vera war zu beobachten. Auf der Basis dieser experimentellen Ergebnisse muss der klinische Einsatz von Dexpanthenol im Rahmen der Supportivtherapie zur Prophylaxe der radiogenen Mucositis enoralis bei der Bestrahlung von Kopf-Hals-Tumoren kritisch ueberdacht werden. Regelmaessige, intensive Mundspuelungen sind jedoch ein probates Mittel zur Verminderung der Strahlenreaktion der Mundschleimhaut. (orig.)

Imaging and Data Acquisition in Clinical Trials for Radiation Therapy

Energy Technology Data Exchange (ETDEWEB)

FitzGerald, Thomas J., E-mail: Thomas.Fitzgerald@umassmed.edu [Imaging and Radiation Oncology Core Rhode Island, University of Massachusetts Memorial Medical Center, University of Massachusetts Medical School, Worcester, Massachusetts (United States); Bishop-Jodoin, Maryann [Imaging and Radiation Oncology Core Rhode Island, University of Massachusetts Medical School, Worcester, Massachusetts (United States); Followill, David S. [Imaging and Radiation Oncology Core Houston, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Galvin, James [Imaging and Radiation Oncology Core Philadelphia, Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Knopp, Michael V. [Imaging and Radiation Oncology Core Ohio, Wexner Medical Center, Ohio State University, Columbus, Ohio (United States); Michalski, Jeff M. [Imaging and Radiation Oncology Core St. Louis, Washington University School of Medicine, St. Louis, Missouri (United States); Rosen, Mark A. [Imaging and Radiation Oncology Core Philadelphia, University of Pennsylvania Health System, Philadelphia, Pennsylvania (United States); Bradley, Jeffrey D. [Washington University School of Medicine–Radiation Oncology, St. Louis, Missouri (United States); Shankar, Lalitha K. [National Cancer Institute, Clinical Radiation Oncology Branch, Rockville, Maryland (United States); Laurie, Fran [Imaging and Radiation Oncology Core Rhode Island, University of Massachusetts Medical School, Worcester, Massachusetts (United States); Cicchetti, M. Giulia; Moni, Janaki [Imaging and Radiation Oncology Core Rhode Island, University of Massachusetts Memorial Medical Center, University of Massachusetts Medical School, Worcester, Massachusetts (United States); Coleman, C. Norman; Deye, James A.; Capala, Jacek; Vikram, Bhadrasain [National Cancer Institute, Clinical Radiation Oncology Branch, Rockville, Maryland (United States)

2016-02-01

Cancer treatment evolves through oncology clinical trials. Cancer trials are multimodal and complex. Assuring high-quality data are available to answer not only study objectives but also questions not anticipated at study initiation is the role of quality assurance. The National Cancer Institute reorganized its cancer clinical trials program in 2014. The National Clinical Trials Network (NCTN) was formed and within it was established a Diagnostic Imaging and Radiation Therapy Quality Assurance Organization. This organization is Imaging and Radiation Oncology Core, the Imaging and Radiation Oncology Core Group, consisting of 6 quality assurance centers that provide imaging and radiation therapy quality assurance for the NCTN. Sophisticated imaging is used for cancer diagnosis, treatment, and management as well as for image-driven technologies to plan and execute radiation treatment. Integration of imaging and radiation oncology data acquisition, review, management, and archive strategies are essential for trial compliance and future research. Lessons learned from previous trials are and provide evidence to support diagnostic imaging and radiation therapy data acquisition in NCTN trials.

Imaging and Data Acquisition in Clinical Trials for Radiation Therapy

International Nuclear Information System (INIS)

FitzGerald, Thomas J.; Bishop-Jodoin, Maryann; Followill, David S.; Galvin, James; Knopp, Michael V.; Michalski, Jeff M.; Rosen, Mark A.; Bradley, Jeffrey D.; Shankar, Lalitha K.; Laurie, Fran; Cicchetti, M. Giulia; Moni, Janaki; Coleman, C. Norman; Deye, James A.; Capala, Jacek; Vikram, Bhadrasain

2016-01-01

Cancer treatment evolves through oncology clinical trials. Cancer trials are multimodal and complex. Assuring high-quality data are available to answer not only study objectives but also questions not anticipated at study initiation is the role of quality assurance. The National Cancer Institute reorganized its cancer clinical trials program in 2014. The National Clinical Trials Network (NCTN) was formed and within it was established a Diagnostic Imaging and Radiation Therapy Quality Assurance Organization. This organization is Imaging and Radiation Oncology Core, the Imaging and Radiation Oncology Core Group, consisting of 6 quality assurance centers that provide imaging and radiation therapy quality assurance for the NCTN. Sophisticated imaging is used for cancer diagnosis, treatment, and management as well as for image-driven technologies to plan and execute radiation treatment. Integration of imaging and radiation oncology data acquisition, review, management, and archive strategies are essential for trial compliance and future research. Lessons learned from previous trials are and provide evidence to support diagnostic imaging and radiation therapy data acquisition in NCTN trials.

Cluster randomised controlled trial of a multicomponent intervention to support the implementation of policies and practices that promote healthier environments at junior sports clubs: study protocol

Science.gov (United States)

Milner, Sharin; Sherker, Shauna; Clinton-McHarg, Tara; Dray, Julia; Zukowski, Nadya; Gonzalez, Sharleen; Kingsland, Melanie; Ooi, Jia Ying; Murphy, Allan; Brooke, Daisy; Wiggers, John

2018-01-01

Introduction A large proportion of children and adolescents participate in organised sport, making community sports clubs a promising setting to support healthy behaviours. To date, however, there have been few interventions conducted in junior sports clubs that have targeted health-promoting practices. The primary aim of this pilot study is to assess the potential effectiveness of an intervention to implement health-promoting policies and practices in junior sporting clubs targeting alcohol and tobacco practices, healthy food and beverage availability, and physical activity via participation in sport. A secondary outcome is to assess the impact of such strategies on child exposure to alcohol and tobacco use at the club, purchasing behaviours by/for children at the club canteen and child sports participation opportunities. Methods and analysis The study will employ a cluster randomised controlled trial design and be conducted in metropolitan and regional areas of two Australian states. Randomisation will occur at the level of the football league. Community football clubs with over 40 junior players (players under 18 years) within each league will be eligible to participate. The intervention will be developed based on frameworks that consider the social, cultural and environmental factors that influence health behaviours. Intervention clubs will be supported to implement 16 practices targeting alcohol management, tobacco use, nutrition practices, new player recruitment activity, equal participation for players and the development of policies to support these practices. Trained research staff will collect outcome data via telephone interviews at baseline and follow-up. Interviews will be conducted with both club representatives and parents of junior players. Ethics and dissemination The study has been approved by the University of Newcastle Human Research Ethics Committee (H-2013-0429). The results of the study will be disseminated via peer-reviewed publications and

Clinical trials for vaccine development in registry of Korea Food and Drug Administration.

Science.gov (United States)

Kang, Seog-Youn

2013-01-01

Based on the action plan "Ensuring a stable supply of National Immunization Program vaccines and sovereignty of biopharmaceutical products," Korea Food and Drug Administration (KFDA) has made efforts to develop vaccines in the context of self reliance and to protect public health. Along with the recognized infrastructures for clinical trials, clinical trials for vaccines have also gradually been conducted at multinational sites as well as at local sites. KFDA will support to expand six to eleven kinds of vaccines by 2017. In accordance with integrated regulatory system, KFDA has promoted clinical trials, established national lot release procedure, and strengthened good manufacturing practices inspection and post marketing surveillance. Against this backdrop, KFDA will support the vaccine development and promote excellent public health protection.

Home exercise programmes supported by video and automated reminders compared with standard paper-based home exercise programmes in patients with stroke: a randomized controlled trial.

Science.gov (United States)

Emmerson, Kellie B; Harding, Katherine E; Taylor, Nicholas F

2017-08-01

To determine whether patients with stroke receiving rehabilitation for upper limb deficits using smart technology (video and reminder functions) demonstrate greater adherence to prescribed home exercise programmes and better functional outcomes when compared with traditional paper-based exercise prescription. Randomized controlled trial comparing upper limb home exercise programmes supported by video and automated reminders on smart technology, with standard paper-based home exercise programmes. A community rehabilitation programme within a large metropolitan health service. Patients with stroke with upper limb deficits, referred for outpatient rehabilitation. Participants were randomly assigned to the control (paper-based home exercise programme) or intervention group (home exercise programme filmed on an electronic tablet, with an automated reminder). Both groups completed their prescribed home exercise programme for four weeks. The primary outcome was adherence using a self-reported log book. Secondary outcomes were change in upper limb function and patient satisfaction. A total of 62 participants were allocated to the intervention ( n = 30) and control groups ( n = 32). There were no differences between the groups for measures of adherence (mean difference 2%, 95% CI -12 to 17) or change in the Wolf Motor Function Test log transformed time (mean difference 0.02 seconds, 95% CI -0.1 to 0.1). There were no between-group differences in how participants found instructions ( p = 0.452), whether they remembered to do their exercises ( p = 0.485), or whether they enjoyed doing their exercises ( p = 0.864). The use of smart technology was not superior to standard paper-based home exercise programmes for patients recovering from stroke. This trial design was registered prospectively with the Australian and New Zealand Clinical Trials Register, ID: ACTRN 12613000786796. http://www.anzctr.org.au/trialSearch.aspx.

Design and trial evaluation of the user interface for MusicReader

NARCIS (Netherlands)

Leoné, Marco; van Dijk, Elisabeth M.A.G.; van Beijnum, Bernhard J.F.

2008-01-01

This paper describes the design and trial results of MusicReader, a networked application realizing sheet music related services for the support of ensemble and orchestra rehearsals and performances. To this end, MusicReader presents sheet music on computer screens and supports annotations, sheet

Publication Speed, Reporting Metrics, and Citation Impact of Cardiovascular Trials Supported by the National Heart, Lung, and Blood Institute.

Science.gov (United States)

Gordon, David; Cooper-Arnold, Katharine; Lauer, Michael

2015-07-31

We previously demonstrated that cardiovascular (CV) trials funded by the National Heart, Lung, and Blood Institute (NHLBI) were more likely to be published in a timely manner and receive high raw citation counts if they focused on clinical endpoints. We did not examine the metrics of trial reports, and our citation measures were limited by failure to account for topic-related citation behaviors. Of 244 CV trials completed between 2000 and 2011, we identified 184 whose main results were published by August 20, 2014. One investigator who was blinded to rapidity of publication and citation data read each publication and characterized it according to modified Delphi criteria. There were 46 trials (25%) that had Delphi scores of 8 or 9 (of a possible 9); these trials published faster (median time from trial completion to publication, 12.6 [interquartile range {IQR}, 6.7 to 23.3] vs. 21.8 [IQR, 12.1 to 34.9] months; Pcitation impact (median citation percentile for topic and date of publication, with 0 best and 100 worst, 1.92 [IQR, 0.64 to 7.83] vs. 8.41 [IQR, 1.80 to 24.75]; P=0.002). By random forest regression, we found that the 3 most important predictors of normalized citation percentile values were total costs, intention-to-treat analyses (as a modified Delphi quality measure), and focus on clinical (not surrogate) endpoints. NHLBI CV trials were more likely to publish results quickly and yield higher topic-normalized citation impact if they reported results according to well-defined metrics, along with focus on clinical endpoints. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Contractualist reasoning, HIV cure clinical trials, and the moral (ir)relevance of the risk/benefit ratio.

Science.gov (United States)

Kumar, Rahul

2017-02-01

Institutional review boards (IRB) normally require of a morally defensible clinical trial that any trial participant will benefit from the inquiry, or at least not be exposed to a significant risk of having their prospects worsened by participating. Stage 1 HIV cure trials tend not to meet this requirement. Does that show them to be morally indefensible? Utilitarian thinking about this question supports a negative answer. But one might reasonably expect a Kantian moral theory to support the conclusion that exposing trial participants to a significant risk of their prospects being worsened by their participation to be morally indefensible, on grounds that this would be a clear case of using a person as a mere means. In this paper, I argue, drawing on Kantian contractualist thinking, that requiring the risk/benefit ratio for participants be positive if a trial is to be morally defensible does not in fact gain any support from Kantian thinking about morality. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

Directory of Open Access Journals (Sweden)

Melanie Calvert

Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

Optimised utilisation of existing incinerators by installation of upstream reactors for treatment of waste with high calorifica value - HYBRID waste treatment plants; Optimierte Nutzung bestehender Abfallverbrennungsanlagen durch Errichtung vorgeschalteter Reaktoren zur Behandlung heizwertreicher Abfaelle - HYBRID-Abfallbehandlungsanlagen

Energy Technology Data Exchange (ETDEWEB)

El Labani, M

2000-07-01

Waste incineration plants are based on the process of thermal waste treatment, i.e. the generation of power from the controlled conversion of organic reactive residue waste. Statutory requirements forced operators to install powerful flue gas cleaning systems into their existing waste incineration plants. This led to a tremendous increase in cost and treatment prices generating pressure to optimize the process. Currently, markets demand additional capacities for the treatment of waste of elevated heating value ({proportional_to}5,0 MWh/Mg). It is possible to treat this type of waste in a conventional waste incineration plant. However, the elevated heating value dictates a reduction in throughput with ever increasing pressure on costs. This is why current concepts consider the treatment of waste of elevated heating value in specific, so called de-centralized plants. These plants are usually of low throughput with accordingly high specific cost of developing the infrastructure. The capacity of existing waste incineration plants has been investigated in order to assess the potential for optimization. Extensive test runs at the Municipal Solid Waste Incineration Plant (MSW) Darmstadt revealed a capacity gap in the flue gas cleaning system even with the incineration unit running at full capacity. This gap could be filled with an additional incineration plant for waste of elevated heating value, whose capacity is matched accordingly. Such additional incineration plant defines in conjunction with the existing waste incineration plant a so called HYBRID Waste Treatment Plant. It is the aim of this treatise to develop an instrument to support the decision making process related to the planning of such plants. (orig.) [German] Abfallverbrennungsanlagen basieren auf dem Verfahren der thermischen Abfallbehandlung; das ist die Energieerzeugung aus der kontrollierten Umwandlung organischer, reaktionsfaehiger Restabfaelle. Aufgrund gesetzlicher Vorgaben mussten bestehende

Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP Trial

Directory of Open Access Journals (Sweden)

Hurley D

2008-03-01

Full Text Available Abstract Background Evidence supports the use of exercise for chronic low back pain (CLBP; however, adherence is often poor due to ongoing pain. Auricular acupuncture is a form of pain relief involving the stimulation of points on the outer ear corresponding with specific body parts. It may be a useful adjunct to exercise in managing CLBP; however, there is only limited evidence to support its use with this patient group. Methods/Design This study was designed to test the feasibility of an assessor-blind randomised controlled trial which assess the effects on clinical outcomes and exercise adherence of adding manual auricular acupuncture to a personalised and supervised exercise programme (PEP for CLBP. No sample size calculation has been carried out as this study aims to identify CLBP referral rates within the catchment area of the study site. The researchers aim to recruit four cohorts of n = 20 participants to facilitate a power analysis for a future randomised controlled trial. A computer generated random allocation sequence will be prepared centrally and used to allocate participants by cohort to one of the following interventions: 1 six weeks of PEP plus manual auricular acupuncture; 2 six weeks of PEP alone. Both groups will also complete a further six weeks of self-paced exercise with telephone follow-up support. In addition to a baseline and exit questionnaire at the beginning and end of the study, the following outcomes will be collected at baseline, and after 7, 13 and 25 weeks: pain frequency and bothersomeness, back-specific function, objective assessment and recall of physical activity, use of analgesia, perceived self-efficacy, fear avoidance beliefs, and beliefs about the consequences of back pain. Since this is a feasibility study, significance tests will not be presented, and treatment effects will be represented by point estimates and confidence intervals. For each outcome variable, analysis of covariance will be performed on

Data-driven risk identification in phase III clinical trials using central statistical monitoring

OpenAIRE

Timmermans, Catherine; Venet, David; Burzykowski, Tomasz

2016-01-01

Our interest lies in quality control for clinical trials, in the context of risk-based monitoring (RBM). We specifically study the use of central statistical monitoring (CSM) to support RBM. Under an RBM paradigm, we claim that CSM has a key role to play in identifying the "risks to the most critical data elements and processes" that will drive targeted oversight. In order to support this claim, we first see how to characterize the risks that may affect clinical trials. We then discuss how CS...

Sharing and reuse of individual participant data from clinical trials

DEFF Research Database (Denmark)

Ohmann, Christian; Banzi, Rita; Canham, Steve

2017-01-01

: The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need......OBJECTIVES: We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. DESIGN AND METHODS: This was a consensus...... Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. OUTCOME: We developed principles and practical recommendations on how to share data...

Guidelines for controlled trials of drugs in tension-type headache: second edition

DEFF Research Database (Denmark)

Bendtsen, L; Bigal, M E; Cerbo, R

2010-01-01

and chronic tension-type headache have been published, providing new information on trial methodology for this disorder. Furthermore, the classification of the headaches, including tension-type headache, has been revised. These developments support the need for also revising the guidelines for drug treatments......The Clinical Trials Subcommittee of the International Headache Society published its first edition of the guidelines on controlled trials of drugs in tension-type headache in 1995. These aimed 'to improve the quality of controlled clinical trials in tension-type headache', because 'good quality...... controlled trials are the only way to convincingly demonstrate the efficacy of a drug, and form the basis for international agreement on drug therapy'. The Committee published similar guidelines for clinical trials in migraine and cluster headache. Since 1995 several studies on the treatment of episodic...

Techniques of material-flow-specific residual waste treatment; Techniken der stoffstromspezifischen Restabfallbehandlung

Energy Technology Data Exchange (ETDEWEB)

Maak, D.; Collins, H.J. [Technische Univ. Braunschweig, Leichtweiss - Inst. fuer Wasserbau (Germany)

1998-09-01

The success achieved with large-scale plants for mechanical-biological residual waste treatment has led to a change of course in waste pretreatment. In view of the low emissions via the water and gas routes from landfilled wastes and the low costs of waste treatment some authorising authorities have meanwhile issued special licences pursuant to clause no. 2.4 of the Technical Code on Household Waste, thus enabling mechanical-biological residual waste treatment plants to continue operations beyond the year 2005. Beside offering a means of treatment and disposal, cost-effective mechanical-biological pretreatment also provides an opportunity for going over to material-flow-specific residual waste treatment. These process stages permit recirculating valuable materials and using other materials for energy production. They can be retrofitted on a modular basis in existing plants. If these advantages of the present innovative pretreatment methods are not used, then mechanical-biological pretreatment can still serve as a preparatory stage for thermal treatment. To date there has been no practical experience with this innovative method of residual waste treatment. However, industrial-scale trials have shown that each individual treatment stage is capable of being carried out successfully. [Deutsch] Die guten Erfolge im grosstechnischen Betrieb von Anlagen zur mechanisch-biologischen Restabfallbehandlung haben zu einer Kursaenderung bei der Vorbehandlung von Abfaellen gefuehrt. Geringe Emissionen der deponierten Abfaelle auf dem Gas- und Wasserpfad sowie geringe Kosten fuer die Behandlung der Abfaelle haben dazu gefuehrt, dass inzwischen bereits einige Genehmigungsbehoerden eine Ausnahmegenehmigung nach Nr. 2.4 der TA Siedlungsabfall erteilt haben und damit der Betrieb von mechanisch-biologischen Restabfallbehandlungsanlagen auch nach 2005 ermoeglicht wird. Neben der alleinigen Behandlung und Deponierung bietet die kostenguenstige Vorbehandlung mit mechanisch

A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial.

Science.gov (United States)

Langhorne, Peter; Wu, Olivia; Rodgers, Helen; Ashburn, Ann; Bernhardt, Julie

2017-09-01

outcome at 3 months cautioning against very early high-dose mobilisation. At 12 months, health-related QoL was similar regardless of group. Shorter, more frequent mobilisation early after stroke may be associated with a more favourable outcome. These results informed a new trial proposal [A Very Early Rehabilitation Trial - DOSE (AVERT-DOSE)] aiming to determine the optimal frequency and dose of EM. The trial is registered with the Australian New Zealand Clinical Trials Registry number ACTRN12606000185561, Current Controlled Trials ISRCTN98129255 and ISRCTN98129255. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 21, No. 54. See the NIHR Journals Library website for further project information. Funding was also received from the National Health and Medical Research Council Australia, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, and the Stroke Association. In addition, National Health and Medical Research Council fellowship funding was provided to Julie Bernhardt (1058635), who also received fellowship funding from the Australia Research Council (0991086) and the National Heart Foundation (G04M1571). The Florey Institute of Neuroscience and Mental Health, which hosted the trial, acknowledges the support received from the Victorian Government via the Operational Infrastructure Support Scheme.

Randomised controlled trials in Scandinavian educational research

DEFF Research Database (Denmark)

Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens

2018-01-01

of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0–10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries...... crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue....... or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0–10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed...

Social Problem Solving and Depressive Symptoms Over Time: A Randomized Clinical Trial of Cognitive Behavioral Analysis System of Psychotherapy, Brief Supportive Psychotherapy, and Pharmacotherapy

Science.gov (United States)

Klein, Daniel N.; Leon, Andrew C.; Li, Chunshan; D’Zurilla, Thomas J.; Black, Sarah R.; Vivian, Dina; Dowling, Frank; Arnow, Bruce A.; Manber, Rachel; Markowitz, John C.; Kocsis, James H.

2011-01-01

Objective Depression is associated with poor social problem-solving, and psychotherapies that focus on problem-solving skills are efficacious in treating depression. We examined the associations between treatment, social problem solving, and depression in a randomized clinical trial testing the efficacy of psychotherapy augmentation for chronically depressed patients who failed to fully respond to an initial trial of pharmacotherapy (Kocsis et al., 2009). Method Participants with chronic depression (n = 491) received Cognitive Behavioral Analysis System of Psychotherapy (CBASP), which emphasizes interpersonal problem-solving, plus medication; Brief Supportive Psychotherapy (BSP) plus medication; or medication alone for 12 weeks. Results CBASP plus pharmacotherapy was associated with significantly greater improvement in social problem solving than BSP plus pharmacotherapy, and a trend for greater improvement in problem solving than pharmacotherapy alone. In addition, change in social problem solving predicted subsequent change in depressive symptoms over time. However, the magnitude of the associations between changes in social problem solving and subsequent depressive symptoms did not differ across treatment conditions. Conclusions It does not appear that improved social problem solving is a mechanism that uniquely distinguishes CBASP from other treatment approaches. PMID:21500885

Support for healthy breastfeeding mothers with healthy term babies

Science.gov (United States)

Renfrew, Mary J; McCormick, Felicia M; Wade, Angela; Quinn, Beverley; Dowswell, Therese

2014-01-01

Background There is extensive evidence of important health risks for infants and mothers related to not breastfeeding. In 2003, the World Health Organization recommended infants be exclusively breastfed until six months of age, with breastfeeding continuing as an important part of the infant’s diet till at least two years of age. However, breastfeeding rates in many countries currently do not reflect this recommendation. Objectives To assess the effectiveness of support for breastfeeding mothers. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (3 October 2011). Selection criteria Randomised or quasi-randomised controlled trials comparing extra support for healthy breastfeeding mothers of healthy term babies with usual maternity care. Data collection and analysis Two review authors independently assessed trial quality and extracted data. Main results Of the 67 studies that we assessed as eligible for inclusion, 52 contributed outcome data to the review (56,451 mother-infant pairs) from 21 countries. All forms of extra support analysed together showed an increase in duration of ‘any breastfeeding’ (includes partial and exclusive breastfeeding) (risk ratio (RR) for stopping any breastfeeding before six months 0.91, 95% confidence interval (CI) 0.88 to 0.96). All forms of extra support together also had a positive effect on duration of exclusive breastfeeding (RR at six months 0.86, 95% CI 0.82 to 0.91; RR at four to six weeks 0.74, 95% CI 0.61 to 0.89). Extra support by both lay and professionals had a positive impact on breastfeeding outcomes. Maternal satisfaction was poorly reported. Authors’ conclusions All women should be offered support to breastfeed their babies to increase the duration and exclusivity of breastfeeding. Support is likely to be more effective in settings with high initiation rates, so efforts to increase the uptake of breastfeeding should be in place. Support may be offered either by

Web-Based Cognitive Remediation Improves Supported Employment Outcomes in Severe Mental Illness: Randomized Controlled Trial.

Science.gov (United States)

Harris, Anthony Wf; Kosic, Tanya; Xu, Jean; Walker, Chris; Gye, William; Redoblado Hodge, Antoinette

2017-09-20

Finding work is a top priority for most people; however, this goal remains out of reach for the majority of individuals with a severe mental illness (SMI) who remain on benefits or are unemployed. Supported employment (SE) programs aimed at returning people with a severe mental illness to work are successful; however, they still leave a significant number of people with severe mental illness unemployed. Cognitive deficits are commonly found in SMI and are a powerful predictor of poor outcome. Fortunately, these deficits are amenable to treatment with cognitive remediation therapy (CRT) that significantly improves cognition in SMI. CRT combined with SE significantly increases the likelihood of individuals with severe mental illness obtaining and staying in work. However, the availability of CRT is limited in many settings. The aim of this study was to examine whether Web-based CRT combined with a SE program can improve the rate return to work of people with severe mental illness. A total of 86 people with severe mental illness (mean age 39.6 years; male: n=55) who were unemployed and who had joined a SE program were randomized to either a Web-based CRT program (CogRem) or an Internet-based control condition (WebInfo). Primary outcome measured was hours worked over 6 months post treatment. At 6 months, those participants randomized to CogRem had worked significantly more hours (P=.01) and had earned significantly more money (P=.03) than those participants randomized to the WebInfo control condition. No change was observed in cognition. This study corroborates other work that has found a synergistic effect of combining CRT with a SE program and extends this to the use of Web-based CRT. The lack of any improvement in cognition obscures the mechanism by which an improved wage outcome for participants randomized to the active treatment was achieved. However, the study substantially lowers the barrier to the deployment of CRT with other psychosocial interventions for

DSSHerbicide: Herbicide field trials in winter wheat. How to come to a decision

Directory of Open Access Journals (Sweden)

Sefzat, David

2014-02-01

Full Text Available Herbicide decision support systems can calculate efficient, economically optimized herbicide mixtures with reduced dosages, if field specific weed data are given. Thus, they can be a sensible tool for integrated weed control. However, advises of decision support systems have to be tested before introducing them into practical farming. In Mecklenburg-Vorpommern two herbicide field trials were installed with four different prototypes of decision support systems. An untreated plot and three expert advices, private advisors, official advisory service and a farmer decision, were included as additional test variables. Herbicide efficacies in autumn, weed dry matter after spring applications, herbicide costs and wheat yield were measured to evaluate the decision support system prototypes. In one field trial with low weed density before treatments efficacies were at least 85%. In two prototypes efficacies were lower than in the expert plots. No significant differences between decision variables were found regarding weed dry matter after spraying in spring. On this site, herbicide costs were higher when expert advises were used compared to decision support system advises. No significant differences were detected in yield. Even yield in “untreated” was not significantly different. The second field trial carried higher weed densities. Here herbicide efficacies were lower in all treatments. Poa annua and Matricaria recutita were significantly affected by the treatments resulting from the decision tools. However, these differences did not result in statistically different weed dry matter or wheat yield. Three of the prototypes advised solutions with very low herbicide costs in autumn, but high costs in spring. As a result, total weed costs in these plots were higher than in the plots advised by experts. It is concluded from the field trials, that different prototypes of decision support systems are giving sensible herbicide advice. In fields with low

Integrating technology into complex intervention trial processes: a case study.

Science.gov (United States)

Drew, Cheney J G; Poile, Vincent; Trubey, Rob; Watson, Gareth; Kelson, Mark; Townson, Julia; Rosser, Anne; Hood, Kerenza; Quinn, Lori; Busse, Monica

2016-11-17

designed to support data collection, intervention fidelity and trial progress provides a viable option for streamlining trial processes in a multicentre complex intervention trial. There is scope to further extend the system to cater for larger trials and add further functionality such as automatic reporting facilities and participant management support. ISRCTN65378754 , registered on 13 March 2014.

Lupus community panel proposals for optimising clinical trials: 2018

Science.gov (United States)

Merrill, Joan T; Manzi, Susan; Aranow, Cynthia; Askenase, Anca; Bruce, Ian; Chakravarty, Eliza; Chong, Ben; Costenbader, Karen; Dall’Era, Maria; Ginzler, Ellen; Hanrahan, Leslie; Kalunian, Ken; Merola, Joseph; Raymond, Sandra; Rovin, Brad; Saxena, Amit; Werth, Victoria P

2018-01-01

Formidable impediments stand in the way of treatment development for lupus. These include the unwieldy size of current trials, international competition for scarce patients, complex outcome measures and a poor understanding of these outcomes in the world at large. The heterogeneity of the disease itself coupled to superimposition of variegated background polypharmacy has created enough immunological noise to virtually ensure the failure of lupus treatment trials, leaving an understandable suspicion that at least some of the results in testing failed drugs over the years may not have been negative, but merely uninterpretable. The authors have consulted with many clinical trial investigators, biopharmaceutical developers and stakeholders from government and voluntary sectors. This paper examines the available evidence that supports workable trial designs and proposes approaches to improve the odds of completing interpretable treatment development programs for lupus. PMID:29657738

EAP viewpoint on unpublished data from paediatric clinical trials.

Science.gov (United States)

Schrier, L; Illy, K; Valiulis, A; Wyder, C; Stiris, T

2018-02-01

European children and paediatricians rely heavily on the fair, complete and timely publication of data obtained from paediatric randomised controlled trials (RCTs). Selective publication and reporting of paediatric RCTs is common practice. Industry-sponsored trials are more likely to remain unpublished, and take longer to get published compared with trials sponsored by others. However, also academic sponsors contribute to inefficiencies in publishing clinical data. Publication bias violates the ethical obligation that investigators have towards study participants, leads to considerable inefficiencies in research and a waste of financial and human resources, and has the potential to distort evidence for treatment approaches. The European Academy of Paediatrics (EAP) therefore actively supports initiatives that increase the public dissemination of paediatric clinical trial data. The EAP will raise awareness about the guidelines for Good Publication Practice among European paediatricians and subspecialty societies.

Systematic data ingratiation of clinical trial recruitment locations for geographic-based query and visualization.

Science.gov (United States)

Luo, Jake; Chen, Weiheng; Wu, Min; Weng, Chunhua

2017-12-01

Prior studies of clinical trial planning indicate that it is crucial to search and screen recruitment sites before starting to enroll participants. However, currently there is no systematic method developed to support clinical investigators to search candidate recruitment sites according to their interested clinical trial factors. In this study, we aim at developing a new approach to integrating the location data of over one million heterogeneous recruitment sites that are stored in clinical trial documents. The integrated recruitment location data can be searched and visualized using a map-based information retrieval method. The method enables systematic search and analysis of recruitment sites across a large amount of clinical trials. The location data of more than 1.4 million recruitment sites of over 183,000 clinical trials was normalized and integrated using a geocoding method. The integrated data can be used to support geographic information retrieval of recruitment sites. Additionally, the information of over 6000 clinical trial target disease conditions and close to 4000 interventions was also integrated into the system and linked to the recruitment locations. Such data integration enabled the construction of a novel map-based query system. The system will allow clinical investigators to search and visualize candidate recruitment sites for clinical trials based on target conditions and interventions. The evaluation results showed that the coverage of the geographic location mapping for the 1.4 million recruitment sites was 99.8%. The evaluation of 200 randomly retrieved recruitment sites showed that the correctness of geographic information mapping was 96.5%. The recruitment intensities of the top 30 countries were also retrieved and analyzed. The data analysis results indicated that the recruitment intensity varied significantly across different countries and geographic areas. This study contributed a new data processing framework to extract and integrate

Systematic data ingratiation of clinical trial recruitment locations for geographic-based query and visualization

Science.gov (United States)

Luo, Jake; Chen, Weiheng; Wu, Min; Weng, Chunhua

2018-01-01

Background Prior studies of clinical trial planning indicate that it is crucial to search and screen recruitment sites before starting to enroll participants. However, currently there is no systematic method developed to support clinical investigators to search candidate recruitment sites according to their interested clinical trial factors. Objective In this study, we aim at developing a new approach to integrating the location data of over one million heterogeneous recruitment sites that are stored in clinical trial documents. The integrated recruitment location data can be searched and visualized using a map-based information retrieval method. The method enables systematic search and analysis of recruitment sites across a large amount of clinical trials. Methods The location data of more than 1.4 million recruitment sites of over 183,000 clinical trials was normalized and integrated using a geocoding method. The integrated data can be used to support geographic information retrieval of recruitment sites. Additionally, the information of over 6000 clinical trial target disease conditions and close to 4000 interventions was also integrated into the system and linked to the recruitment locations. Such data integration enabled the construction of a novel map-based query system. The system will allow clinical investigators to search and visualize candidate recruitment sites for clinical trials based on target conditions and interventions. Results The evaluation results showed that the coverage of the geographic location mapping for the 1.4 million recruitment sites was 99.8%. The evaluation of 200 randomly retrieved recruitment sites showed that the correctness of geographic information mapping was 96.5%. The recruitment intensities of the top 30 countries were also retrieved and analyzed. The data analysis results indicated that the recruitment intensity varied significantly across different countries and geographic areas. Conclusion This study contributed a new

Counterbalancing patient demands with evidence: results from a pan-Canadian randomized clinical trial of brief supportive-expressive group psychotherapy for women with systemic lupus erythematosus.

Science.gov (United States)

Dobkin, Patricia L; Da Costa, Deborah; Joseph, Lawrence; Fortin, Paul R; Edworthy, Steven; Barr, Susan; Ensworth, Stephanie; Esdaile, John M; Beaulieu, André; Zummer, Michel; Senécal, Jean-Luc; Goulet, Jean-Richard; Choquette, Denis; Rich, Eric; Smith, Doug; Cividino, Alfred; Gladman, Dafna; St-Pierre, Yvan; Clarke, Ann E

2002-01-01

To evaluate the effect of Brief Supportive-Expressive Group Psychotherapy as an adjunct to standard medical care in reducing psychological distress, medical symptoms, and health care costs and improving quality of life in women with systemic lupus erythematosus (SLE). A randomized clinical trial was conducted with 133 SLE female patients from 9 clinics across Canada. Clinical and psychosocial measures were taken at baseline, posttreatment, and 6 and 12 months posttreatment. Outcomes assessed were psychological distress, quality of life, disease activity, health service utilization, and diminished productivity. Intention-to-treat analyses revealed that there were no clinically important group differences on any of the outcome measures. Although both groups improved over time on several measures (e.g., decreases in psychological distress, stress, and emotion-oriented coping), these changes could not be attributed to the psychotherapeutic intervention. Thus, evidence does not support the referral of these patients to this type of intervention.

Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group.

Science.gov (United States)

Goey, Kaitlyn K H; Sørbye, Halfdan; Glimelius, Bengt; Adams, Richard A; André, Thierry; Arnold, Dirk; Berlin, Jordan D; Bodoky, György; de Gramont, Aimery; Díaz-Rubio, Eduardo; Eng, Cathy; Falcone, Alfredo; Grothey, Axel; Heinemann, Volker; Hochster, Howard S; Kaplan, Richard S; Kopetz, Scott; Labianca, Roberto; Lieu, Christopher H; Meropol, Neal J; Price, Timothy J; Schilsky, Richard L; Schmoll, Hans-Joachim; Shacham-Shmueli, Einat; Shi, Qian; Sobrero, Alberto F; Souglakos, John; Van Cutsem, Eric; Zalcberg, John; van Oijen, Martijn G H; Punt, Cornelis J A; Koopman, Miriam

2018-06-21

Patient characteristics and stratification factors are key features influencing trial outcomes. However, there is substantial heterogeneity in reporting of patient characteristics and use of stratification factors in phase 3 trials investigating systemic treatment of metastatic colorectal cancer (mCRC). We aimed to develop a minimum set of essential baseline characteristics and stratification factors to include in such trials. We performed a modified, two-round Delphi survey among international experts with wide experience in the conduct and methodology of phase 3 trials of systemic treatment of mCRC. Thirty mCRC experts from 15 different countries completed both consensus rounds. A total of 14 patient characteristics were included in the recommended set: age, performance status, primary tumour location, primary tumour resection, prior chemotherapy, number of metastatic sites, liver-only disease, liver involvement, surgical resection of metastases, synchronous versus metachronous metastases, (K)RAS and BRAF mutation status, microsatellite instability/mismatch repair status and number of prior treatment lines. A total of five patient characteristics were considered the most relevant stratification factors: RAS/BRAF mutation status, performance status, primary tumour sidedness and liver-only disease. This survey provides a minimum set of essential baseline patient characteristics and stratification factors to include in phase 3 trials of systemic treatment of mCRC. Inclusion of these patient characteristics and strata in study protocols and final study reports will improve interpretation of trial results and facilitate cross-study comparisons. Copyright © 2018 Elsevier Ltd. All rights reserved.

Is Omega-3 Fatty Acids Enriched Nutrition Support Safe for Critical Ill Patients? A Systematic Review and Meta-Analysis

Directory of Open Access Journals (Sweden)

Wei Chen

2014-05-01

Full Text Available Objective: To systematically review the effects of omega-3 poly unsaturated fatty acids (FA enriched nutrition support on the mortality of critically illness patients. Methods: Databases of Medline, ISI, Cochrane Library, and Chinese Biomedicine Database were searched and randomized controlled trials (RCTs were identified. We enrolled RCTs that compared fish oil enriched nutrition support and standard nutrition support. Major outcome is mortality. Methodological quality assessment was conducted based on Modified Jadad’s score scale. For control heterogeneity, we developed a method that integrated I2 test, nutritional support route subgroup analysis and clinical condition of severity. RevMan 5.0 software (The Nordic Cochrane Centre, Copenhagen, Denmark was used for meta-analysis. Results: Twelve trials involving 1208 patients that met all the inclusion criteria. Heterogeneity existed between the trials. A random model was used, there was no significant effect on mortality RR, 0.82, 95% confidence interval (CI (0.62, 1.09, p = 0.18. Knowing that the route of fish oil administration may affect heterogeneity, we categorized the trials into two sub-groups: parenteral administration (PN of omega-3 and enteral administration (EN of omega-3. Six trials administered omega-3 FA through PN. Pooled results indicated that omega-3 FA had no significant effect on mortality, RR 0.76, 95% CI (0.52, 1.10, p = 0.15. Six trials used omega-3 fatty acids enriched EN. After excluded one trial that was identified as source of heterogeneity, pooled data indicated omega-3 FA enriched EN significant reduce mortality, RR=0.69, 95% CI [0.53, 0.91] (p = 0.007. Conclusion: Omega-3 FA enriched nutrition support is safe. Due to the limited sample size of the included trials, further large-scale RCTs are needed.

SAFIRA project B.3.3: in-situ-treatment of contaminated ground water by catalytic oxidation. Final report; Sanierungsforschung in regional kontaminierten Aquiferen (SAFIRA). Projekt B.3.3: In situ-Behandlung von kontaminierten Grundwaessern durch katalytische Oxidation. Teilvorhaben 1: Untersuchungen im Labormassstab. Teilvorhaben 2: Tests in der bench-scale-Anlage und Teilvorhaben 3: Die Erprobung in der Pilotanlage am Modellstandort. Abschlussbericht

Energy Technology Data Exchange (ETDEWEB)

Hofmann, J.; Haentzschel, D.; Freier, U.; Wecks, M.

2003-06-27

A new technology for treatment of contaminated ground water was developed. In this process heterogeneous catalysts (full metal catalyst, mixed oxide catalyst or iron-containing zeolites) in combination with hydrogen peroxide are used. In the reactor catalytic oxidation and aerob biological degradation occur simultaneously. A complete degradation of chlorobenzene was observed in a bench-scale-equipment (2 liter) and also in the pilot plant at the model site located in Bitterfeld (30 liter reactor). The technology can be applied to the ground and waste water treatment. (orig.) [German] Fuer die Behandlung von Grundwaessern, die mit organischen Schadstoffen belastet sind, wurde ein neuartiges Verfahren entwickelt. Bei der katalytischen Oxidation werden heterogene Katalysatoren in Form von Vollmetall-, Mischoxid- und Traegerkatalysatoren in Verbindung mit Wasserstoffperoxid als Oxidationsmittel eingesetzt. In den Katalysereaktoren laufen die heterogen-katalytische Oxidation und der aerob-biologische Abbau nebeneinander ab. Es werden synergistische Effekte erzielt. Mit dem Verfahren wurde in einer bench-scale-Angle (2 Liter) und in der Pilotanlage am Modellstandort in Bitterfeld (30 l Reaktor) der Schadstoff Chlorbenzol vollstaendig umgesetzt. Das Verfahren kann zur Grund- und Abwasserbehandlung eingesetzt werden. (orig.)

Improved Endpoints for Cancer Immunotherapy Trials

Science.gov (United States)

Eggermont, Alexander M. M.; Janetzki, Sylvia; Hodi, F. Stephen; Ibrahim, Ramy; Anderson, Aparna; Humphrey, Rachel; Blumenstein, Brent; Wolchok, Jedd

2010-01-01

Unlike chemotherapy, which acts directly on the tumor, cancer immunotherapies exert their effects on the immune system and demonstrate new kinetics that involve building a cellular immune response, followed by changes in tumor burden or patient survival. Thus, adequate design and evaluation of some immunotherapy clinical trials require a new development paradigm that includes reconsideration of established endpoints. Between 2004 and 2009, several initiatives facilitated by the Cancer Immunotherapy Consortium of the Cancer Research Institute and partner organizations systematically evaluated an immunotherapy-focused clinical development paradigm and created the principles for redefining trial endpoints. On this basis, a body of clinical and laboratory data was generated that supports three novel endpoint recommendations. First, cellular immune response assays generate highly variable results. Assay harmonization in multicenter trials may minimize variability and help to establish cellular immune response as a reproducible biomarker, thus allowing investigation of its relationship with clinical outcomes. Second, immunotherapy may induce novel patterns of antitumor response not captured by Response Evaluation Criteria in Solid Tumors or World Health Organization criteria. New immune-related response criteria were defined to more comprehensively capture all response patterns. Third, delayed separation of Kaplan–Meier curves in randomized immunotherapy trials can affect results. Altered statistical models describing hazard ratios as a function of time and recognizing differences before and after separation of curves may allow improved planning of phase III trials. These recommendations may improve our tools for cancer immunotherapy trials and may offer a more realistic and useful model for clinical investigation. PMID:20826737

Clinical Trials

Medline Plus

Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

Science.gov (United States)

Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

2015-01-01

Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

Best practice for analysis of shared clinical trial data

Directory of Open Access Journals (Sweden)

Sally Hollis

2016-07-01

Full Text Available Abstract Background Greater transparency, including sharing of patient-level data for further research, is an increasingly important topic for organisations who sponsor, fund and conduct clinical trials. This is a major paradigm shift with the aim of maximising the value of patient-level data from clinical trials for the benefit of future patients and society. We consider the analysis of shared clinical trial data in three broad categories: (1 reanalysis - further investigation of the efficacy and safety of the randomized intervention, (2 meta-analysis, and (3 supplemental analysis for a research question that is not directly assessing the randomized intervention. Discussion In order to support appropriate interpretation and limit the risk of misleading findings, analysis of shared clinical trial data should have a pre-specified analysis plan. However, it is not generally possible to limit bias and control multiplicity to the extent that is possible in the original trial design, conduct and analysis, and this should be acknowledged and taken into account when interpreting results. We highlight a number of areas where specific considerations arise in planning, conducting, interpreting and reporting analyses of shared clinical trial data. A key issue is that that these analyses essentially share many of the limitations of any post hoc analyses beyond the original specified analyses. The use of individual patient data in meta-analysis can provide increased precision and reduce bias. Supplemental analyses are subject to many of the same issues that arise in broader epidemiological analyses. Specific discussion topics are addressed within each of these areas. Summary Increased provision of patient-level data from industry and academic-led clinical trials for secondary research can benefit future patients and society. Responsible data sharing, including transparency of the research objectives, analysis plans and of the results will support appropriate

Combination of biological treatment of waste air and liquid effluents in small and medium-sized businesses by using spherical carrier media in exchange with each other. Final report; Kombination der biologischen Behandlung von Abluft- und Abwasserreinigung in kleinen und mittleren Unternehmen durch die Verwendung von kugeligen Traegermaterialien im gegenseitigen Austausch. Abschlussbericht

Energy Technology Data Exchange (ETDEWEB)

Kunz, P.M.; Brunk, M.; Bentz, P.; Bach, K.; Marcos del Rio, O.; Stahl, B.; Wolf, C.

2002-05-08

A combined system for biological treatment of solvent-contaminated liquid and gaseous effluents was to be constructed. The system was to be mobile for demonstration purposes in industrial processes and was to serve for dimensioning of full-scale systems. The system works by a combined process via exchange of spherical carriers with a growth of micro-organisms. Two pilot systems of the Institut fuer Biologische Verfahrenstechnik, one for liquid and one for gaseous effluents, were combined for this purpose, ensuring exchange of carrier materials between the two units. (orig.) [German] Aufgabe im Rahmen dieses F+E-Vorhabens war es gewesen, eine kombinierte biologische Abluft- und Abwasserreinigungsanlage - speziell fuer loesungsmittelhaltige Abluft und Abwaesser - zu untersuchen. Dazu sollte eine Anlage aufgebaut werden, die auch als Demonstrations- und Versuchsanlage zu Industriebetrieben gebracht und dort zur Dimensionierung von full-scale-Anlage eingesetzt werden kann. Idee fuer dieses Vorhaben war gewesen, die Kombination beider Behandlungssysteme ueber den Austausch von mit Mikroorganismen bewachsenem Traegermaterial herzustellen. Am Institut fuer Biologische Verfahrenstechnik existierte bereits eine Pilotanlage fuer die biologische Abwasserreinigung mit kugeligem Traegermaterial (Vario-Bio-Reaktor) und eine Pilotanlage fuer die biologische Behandlung von Abluft nach dem Trickling-Filter-Prinzip mit ebenfalls kugeligem Traegermaterial. Diese beiden Anlagen sollten miteinander kombiniert und der Austausch des Traegermaterials hergestellt werden. (orig.)

Decision support systems

DEFF Research Database (Denmark)

Jørgensen, L.N.; Noe, E.; Langvad, A.M.

2007-01-01

system Crop Protection Online is widely used by advisors and as a learning tool for students. Although the system has been validated in many field trials over the years and has shown reliable results, the number of end-users among farmers has been relatively low during the last 10 years (approximately...... 1000 farmers). A sociological investigation of farmers' decision-making styles in the area of crop protection has shown that arable farmers can be divided into three major groups: (a) system-orientated farmers, (b) experience-based farmers and (c) advisory-orientated farmers. The information required...... by these three groups to make their decisions varies and therefore different ways of using decision support systems need to be provided. Decision support systems need to be developed in close dialogue and collaboration with user groups....

Improving fundamental movement skills in Hong Kong students through an assessment for learning intervention that emphasizes fun, mastery, and support: the A + FMS randomized controlled trial study protocol.

Science.gov (United States)

Chan, Cecilia; Ha, Amy; Ng, Johan Y Y

2016-01-01

Assessment for learning has been identified as an effective strategy to help children learn more effectively. Developing children to master basic movement skills in primary school requires formative assessments to inform instruction and learning. This study reports the rationale and methods for an assessment-based intervention that emphasizes fun, mastery and support (A + FMS) designed to improve fundamental movement skill (FMS) proficiency of primary schoolchildren. Utilizing a cluster randomized controlled trial, the A + FMS intervention was designed to improve FMS proficiency of Hong Kong Chinese schoolchildren. A target sample of 282 students or more from 10 Grade 3 classes (from five schools) will be recruited and randomly assigned into an experimental group or a wait-list control group. Competence motivation theory provided a framework for the intervention that emphasizes fun activities to develop basic fundamentals, improving mastery of movement, and providing support for teaching and learning skills. Primary outcome measures are the raw scores of six objectively measured FMS (i.e., jump, hop, skip, dribble, catch, and overhand throw). Secondary outcomes include self-reported measures: enjoyment in physical education, perceived physical competence, perceived skill competence, and perceived social support. Teachers in the experimental group are required to attend a six-h training workshop and integrate 550 min of assessment for learning strategies into their physical education lessons. Resources such as videos, skills checklists, and equipment will also be provided to support children to accumulate extra learning and practice time after school. The rate of changes in primary and secondary outcomes across the experimental and control groups will be compared to determine the effectiveness of the program. The A + FMS is an innovative school-based intervention targeting improvements in movement mastery by supporting physical education teachers in FMS

Internet trials: participant experiences and perspectives.

Science.gov (United States)

Mathieu, Erin; Barratt, Alexandra; Carter, Stacy M; Jamtvedt, Gro

2012-10-23

disadvantages for researchers; technical aspects of using the Internet; and the impact of Internet data collection on information quality. Overall, more advantages were noted by participants, consistent with their preference for this mode of research over others. The majority of participants (69%) would prefer to participate in Internet-based research compared to other modes of data collection in the future. Participants in our survey would prefer to participate in Internet-based trials in the future compared to other ways of conducting trials. From the participants' perspective, participating in Internet-based trials involves trade-offs. The central trade-off is between flexibility and convenience - a perceived benefit - and lack of connectedness and understanding - a perceived disadvantage. Strategies to maintain the convenience of the Internet while increasing opportunities for participants to feel supported, well-informed and well-understood would seem likely to increase the acceptability of Internet-based trials.

Where are clinical trials going? Society and clinical trials.

Science.gov (United States)

Sleight, P

2004-02-01

Clinical trials now increasingly impinge on society at large. First there is growing emphasis from health organizations on the need for unbiased evidence about the effectiveness of promoted remedies. Second, as most novel treatments accrue increased costs to society, these need to be evaluated in terms of value for money. Third, there has been confusion and concern about the resolution of conflicting evidence, especially the role of advertising and commercial pressures from a powerful pharmaceutical industry motivated by profit. Fourth, there is concern about research fraud and the ethics of clinical trials. Fifth, there is increasing suspicion of political advice, which sometimes has sought to reassure an anxious public on the basis of complex and possibly inadequate scientific information. Some of these issues are addressed by truly independent and properly constituted data and safety monitoring committees, which are of particular importance when academic investigators or universities have a large financial conflict of interest. This is now more problematic with the current encouragement of investigator-led spin-off companies. These issues are best resolved by independent financial support (from government or other institutions) rather than relying on the commercial sponsor.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial.

Science.gov (United States)

Cook, Deborah J; Johnstone, Jennie; Marshall, John C; Lauzier, Francois; Thabane, Lehana; Mehta, Sangeeta; Dodek, Peter M; McIntyre, Lauralyn; Pagliarello, Joe; Henderson, William; Taylor, Robert W; Cartin-Ceba, Rodrigo; Golan, Eyal; Herridge, Margaret; Wood, Gordon; Ovakim, Daniel; Karachi, Tim; Surette, Michael G; Bowdish, Dawn M E; Lamarche, Daphnee; Verschoor, Chris P; Duan, Erick H; Heels-Ansdell, Diane; Arabi, Yaseen; Meade, Maureen

2016-08-02

Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients. Clinicaltrials

Generalizing Evidence From Randomized Clinical Trials to Target Populations

Science.gov (United States)

Cole, Stephen R.; Stuart, Elizabeth A.

2010-01-01

Properly planned and conducted randomized clinical trials remain susceptible to a lack of external validity. The authors illustrate a model-based method to standardize observed trial results to a specified target population using a seminal human immunodeficiency virus (HIV) treatment trial, and they provide Monte Carlo simulation evidence supporting the method. The example trial enrolled 1,156 HIV-infected adult men and women in the United States in 1996, randomly assigned 577 to a highly active antiretroviral therapy and 579 to a largely ineffective combination therapy, and followed participants for 52 weeks. The target population was US people infected with HIV in 2006, as estimated by the Centers for Disease Control and Prevention. Results from the trial apply, albeit muted by 12%, to the target population, under the assumption that the authors have measured and correctly modeled the determinants of selection that reflect heterogeneity in the treatment effect. In simulations with a heterogeneous treatment effect, a conventional intent-to-treat estimate was biased with poor confidence limit coverage, but the proposed estimate was largely unbiased with appropriate confidence limit coverage. The proposed method standardizes observed trial results to a specified target population and thereby provides information regarding the generalizability of trial results. PMID:20547574

A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

Science.gov (United States)

Guise, Jeanne‐Marie; Dolor, Rowena J.; Meissner, Paul; Tunis, Sean; Krishnan, Jerry A.; Pace, Wilson D.; Saltz, Joel; Hersh, William R.; Michener, Lloyd; Carey, Timothy S.

2014-01-01

Abstract An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials. PMID:24472114

Construction of ethics in clinical research: clinical trials registration

Directory of Open Access Journals (Sweden)

C. A. Caramori

2007-01-01

Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

Initiating Nutritional Support Before 72 Hours Is Associated With Favorable Outcome After Severe Traumatic Brain Injury in Children: A Secondary Analysis of a Randomized, Controlled Trial of Therapeutic Hypothermia.

Science.gov (United States)

Meinert, Elizabeth; Bell, Michael J; Buttram, Sandra; Kochanek, Patrick M; Balasubramani, Goundappa K; Wisniewski, Stephen R; Adelson, P David

2018-04-01

To understand the relationship between the timing of initiation of nutritional support in children with severe traumatic brain injury and outcomes. Secondary analysis of a randomized, controlled trial of therapeutic hypothermia (Pediatric Traumatic Brain Injury Consortium: Hypothermia, also known as "the Cool Kids Trial" (NCT 00222742). Fifteen clinical sites in the United States, Australia, and New Zealand. Inclusion criteria included 1) age less than 18 years, 2) postresuscitation Glasgow Coma Scale less than or equal to 8, 3) Glasgow Coma Scale motor score less than 6, and 4) available to be randomized within 6 hours after injury. Exclusion criteria included normal head CT, Glasgow Coma Scale equals to 3, hypotension for greater than 10 minutes ( 30 min), pregnancy, penetrating injury, and unavailability of a parent or guardian to consent at centers without emergency waiver of consent. Therapeutic hypothermia (32-33°C for 48 hr) followed by slow rewarming for the primary study. For this analysis, the only intervention was the extraction of data regarding nutritional support from the existing database. Timing of initiation of nutritional support was determined and patients stratified into four groups (group 1-no nutritional support over first 7 d; group 2-nutritional support initiated group 3-nutritional support initiated 48 to group 4-nutritional support initiated 72-168 hr after injury). Outcomes were also stratified (mortality and Glasgow Outcomes Scale-Extended for Pediatrics; 1-4, 5-7, 8) at 6 and 12 months. Mixed-effects models were performed to define the relationship between nutrition and outcome. Children (n = 90, 77 randomized, 13 run-in) were enrolled (mean Glasgow Coma Scale = 5.8); the mortality rate was 13.3%. 57.8% of subjects received hypothermia Initiation of nutrition before 72 hours was associated with survival (p = 0.01), favorable 6 months Glasgow Outcomes Scale-Extended for Pediatrics (p = 0.03), and favorable 12 months Glasgow

A Randomized Controlled Trial of a Nurse-Led Supportive Care Package (SurvivorCare) for Survivors of Colorectal Cancer.

Science.gov (United States)

Jefford, Michael; Gough, Karla; Drosdowsky, Allison; Russell, Lahiru; Aranda, Sanchia; Butow, Phyllis; Phipps-Nelson, Jo; Young, Jane; Krishnasamy, Mei; Ugalde, Anna; King, Dorothy; Strickland, Andrew; Franco, Michael; Blum, Robert; Johnson, Catherine; Ganju, Vinod; Shapiro, Jeremy; Chong, Geoffrey; Charlton, Julie; Haydon, Andrew; Schofield, Penelope

2016-08-01

Colorectal cancer (CRC) and its treatments can cause distressing sequelae. We conducted a multicenter randomized controlled trial aiming to improve psychological distress, supportive care needs (SCNs), and quality of life (QOL) of patients with CRC. The intervention, called SurvivorCare (SC), comprised educational materials, needs assessment, survivorship care plan, end-of-treatment session, and three follow-up telephone calls. At the end of treatment for stage I-III CRC, eligible patients were randomized 1:1 to usual care (UC) or to UC plus SC. Distress (Brief Symptom Inventory 18), SCNs (Cancer Survivors' Unmet Needs measure), and QOL (European Organization for Research and Treatment of Cancer [EORTC] QOL questionnaires C30 and EORTC CRC module CR29) were assessed at baseline and at 2 and 6 months (follow-up 1 [FU1] and FU2, respectively). The primary hypothesis was that SC would have a beneficial effect on distress at FU1. The secondary hypotheses were that SC would have a beneficial effect on (a) SCN and QOL at FU1 and on (b) distress, SCNs, and QOL at FU2. A total of 15 items assessed experience of care. Of 221 patients randomly assigned, 4 were ineligible for the study and 1 was lost to FU, leaving 110 in the UC group and 106 in the SC group. Patients' characteristics included the following: median age, 64 years; men, 52%; colon cancer, 56%; rectal cancer, 35%; overlapping sites of disease, 10%; stage I disease, 7%; stage II, 22%; stage III, 71%. Baseline distress and QOL scores were similar to population norms. Between-group differences in distress at FU1 (primary outcome) and at FU2, and SCNs and QOL at FU1 and FU2 were small and nonsignificant. Patients in the SC group were more satisfied with survivorship care than those in the UC group (significant differences on 10 of 15 items). The addition of SC to UC did not have a beneficial effect on distress, SCNs, or QOL outcomes, but patients in the SC group were more satisfied with care. Some survivors of

Determinants of hospitalization in Chinese patients with type 2 diabetes receiving a peer support intervention and JADE integrated care: the PEARL randomised controlled trial.

Science.gov (United States)

Yeung, Roseanne O; Cai, Jing-Heng; Zhang, Yuying; Luk, Andrea O; Pan, Jun-Hao; Yin, Junmei; Ozaki, Risa; Kong, Alice P S; Ma, Ronald; So, Wing-Yee; Tsang, Chiu Chi; Lau, K P; Fisher, Edwin; Goggins, Williams; Oldenburg, Brian; Chan, Julianna

2018-01-01

In a randomized controlled trial of 628 Chinese patients with type 2 diabetes receiving multidisciplinary care in the Joint Asia Diabetes Evaluation (JADE) Progam, 372 were randomized to receive additional telephone-based peer support (Peer Empowerment And Remote communication Linked by information technology, PEARL) intervention. After 12 months, all-cause hospitalization was reduced by half in the PEARL group especially in those with high Depression Anxiety and Stress Scale (DASS) scores. We used stratified analyses, negative binomial regression, and structural equation modelling (SEM) to examine the inter-relationships between emotions, self-management, cardiometabolic risk factors, and hospitalization. Hospitalized patients were older, more likely to have heart or kidney disease, and negative emotions than those without hospitalization. Patients with high DASS score who did not receive peer support had the highest hospitalization rates. After adjustment for confounders, peer support reduced the frequency of hospitalizations by 48% with a relative risk of 0.52 (95% CI 0·35-0·79; p  = 0·0018). Using SEM, improvement of negative emotions reduced treatment nonadherence (Est = 0.240, p  = 0.034) and hospitalizations (Est=-0.218, p  = 0.001). The latter was also reduced by an interactive term of peer support and chronic kidney disease (Est = 0.833, p  = diabetes, improvement of negative emotions and peer support reduced hospitalizations, especially in those with comorbidities, in part mediated through improving treatment nonadherence. Integrating peer support is feasible and adds value to multidisciplinary care, augmented by information technology, especially in patients with comorbidities. NCT00950716 Registered July 31, 2009.

Basic life support trained nurses ventilate more efficiently with laryngeal mask supreme than with facemask or laryngeal tube suction-disposable--a prospective, randomized clinical trial.

Science.gov (United States)

Gruber, Elisabeth; Oberhammer, Rosmarie; Balkenhol, Karla; Strapazzon, Giacomo; Procter, Emily; Brugger, Hermann; Falk, Markus; Paal, Peter

2014-04-01

In some emergency situations resuscitation and ventilation may have to be performed by basic life support trained personnel, especially in rural areas where arrival of advanced life support teams can be delayed. The use of advanced airway devices such as endotracheal intubation has been deemphasized for basically-trained personnel, but it is unclear whether supraglottic airway devices are advisable over traditional mask-ventilation. In this prospective, randomized clinical single-centre trial we compared airway management and ventilation performed by nurses using facemask, laryngeal mask Supreme (LMA-S) and laryngeal tube suction-disposable (LTS-D). Basic life support trained nurses (n=20) received one-hour practical training with each device. ASA 1-2 patients scheduled for elective surgery were included (n=150). After induction of anaesthesia and neuromuscular block nurses had two 90-second attempts to manage the airway and ventilate the patient with volume-controlled ventilation. Ventilation failed in 34% of patients with facemask, 2% with LMA-S and 22% with LTS-D (P<0.001). In patients who could be ventilated successfully mean tidal volume was 240±210 ml with facemask, 470±120 ml with LMA-S and 470±140 ml with LTS-D (P<0.001). Leak pressure was lower with LMA-S (23.3±10.8 cm H2O, 95% CI 20.2-26.4) than with LTS-D (28.9±13.9 cm·H2O, 95% CI 24.4-33.4; P=0.047). After one hour of introductory training, nurses were able to use LMA-S more effectively than facemask and LTS-D. High ventilation failure rates with facemask and LTS-D may indicate that additional training is required to perform airway management adequately with these devices. High-level trials are needed to confirm these results in cardiac arrest patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Mobile access to virtual randomization for investigator-initiated trials.

Science.gov (United States)

Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization

Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Dregan Alex

2012-10-01

Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

Alzheimer's Disease: Lessons Learned from Amyloidocentric Clinical Trials.

Science.gov (United States)

Soejitno, Andreas; Tjan, Anastasia; Purwata, Thomas Eko

2015-06-01

Alzheimer's disease (AD) is one of the most debilitating neurodegenerative diseases and is predicted to affect 1 in 85 people by 2050. Despite much effort to discover a therapeutic strategy to prevent progression or to cure AD, to date no effective disease-modifying agent is available that can prevent, halt, or reverse the cognitive and functional decline of patients with AD. Several underlying etiologies to this failure are proposed. First, accumulating evidence from past trials suggests a preventive as opposed to therapeutic paradigm, and the precise temporal and mechanistic relationship of β-amyloid (Aβ) and tau protein should be elucidated to confirm this hypothesis. Second, we are in urgent need of revised diagnostic criteria to support future trials. Third, various technical and methodological improvements are required, based on the lessons learned from previous failed trials.

Setting up a clinical trial for a novel disease: a case study of the Doxycycline for the Treatment of Nodding Syndrome Trial - challenges, enablers and lessons learned.

Science.gov (United States)

Anguzu, Ronald; Akun, Pamela R; Ogwang, Rodney; Shour, Abdul Rahman; Sekibira, Rogers; Ningwa, Albert; Nakamya, Phellister; Abbo, Catherine; Mwaka, Amos D; Opar, Bernard; Idro, Richard

2018-01-01

A large amount of preparation goes into setting up trials. Different challenges and lessons are experienced. Our trial, testing a treatment for nodding syndrome, an acquired neurological disorder of unknown cause affecting thousands of children in Eastern Africa, provides a unique case study. As part of a study to determine the aetiology, understand pathogenesis and develop specific treatment, we set up a clinical trial in a remote district hospital in Uganda. This paper describes our experiences and documents supportive structures (enablers), challenges faced and lessons learned during set-up of the trial. Protocol development started in September 2015 with phased recruitment of a critical study team. The team spent 12 months preparing trial documents, procurement and training on procedures. Potential recruitment sites were pre-visited, and district and local leaders met as key stakeholders. Key enablers were supportive local leadership and investment by the district and Ministry of Health. The main challenges were community fears about nodding syndrome, adverse experiences of the community during previous research and political involvement. Other challenges included the number and delays in protocol approvals and lengthy procurement processes. This hard-to-reach area has frequent power and Internet fluctuations, which may affect cold chains for study samples, communication and data management. These concerns decreased with a pilot community engagement programme. Experiences and lessons learnt can reduce the duration of processes involved in trial-site set-up. A programme of community engagement and local leader involvement may be key to the success of a trial and in reducing community opposition towards participation in research.

TU-G-BRB-00: Clinical Trials in Proton and Particle Therapy

International Nuclear Information System (INIS)

2015-01-01

Proton therapy, in particular, and ion therapy, just beginning, are becoming an increasing focus of attention in clinical radiation oncology and medical physics. Both modalities have been criticized of lacking convincing evidence from randomized trials proving their efficacy, justifying the higher costs involved in these therapies. This session will provide an overview of the current status of clinical trials in proton therapy, including recent developments in ion therapy. As alluded to in the introductory talk by Dr. Schulte, opinions are diverging widely as to the usefulness and need for clinical trials in particle therapy and the challenge of equipoise. The lectures will highlight some of the challenges that surround clinical trials in particle therapy. One, presented by Dr. Choy from UT Southwestern, is that new technology and even different types of particles such as helium and carbon ions are introduced into this environment, increasing the phase space of clinical variables. The other is the issue of medical physics quality assurance with physical phantoms, presented by Mrs. Taylor from IROC Houston, which is more challenging because 3D and 4D image guidance and active delivery techniques are in relatively early stages of development. The role of digital phantoms in developing clinical treatment planning protocols and as a QA tool will also be highlighted by Dr. Lee from NCI. The symposium will be rounded off by a panel discussion among the Symposium speakers, arguing pro or con the need and readiness for clinical trials in proton and ion therapy. Learning Objectives: To get an update on the current status of clinical trials allowing or mandating proton therapy. Learn about the status of planned clinical trials in the U.S. and worldwide involving ion therapy. Discuss the challenges in the design and QA of clinical trials in particle therapy. Learn about existing and future physical and computational anthropomorphic phantoms for charged particle clinical trial

European Marketing Authorizations Granted Based on a Single Pivotal Clinical Trial: The Rule or the Exception?

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Morant, Anne Vinther; Vestergaard, Henrik Tang

2018-07-01

A minimum of two positive, adequate, and well-controlled clinical trials has historically been the gold standard for providing substantial evidence to support regulatory approval of a new medicine. Nevertheless, the present analysis of European Marketing Authorizations granted between 2012 and 2016 showed that 45% of new active substances were approved based on a single pivotal clinical trial. For therapeutic areas such as oncology and cardiovascular diseases, approvals based on a single pivotal trial are the rule rather than the exception, whereas new medicines within the nervous system area were generally supported by two or more pivotal trials. While overall similar trends have been observed in the US, the recent US Food and Drug Administration approvals of nervous system medicines based on a single pivotal trial suggest that a case-by-case scientific evaluation of the totality of evidence is increasingly applied to facilitate faster access of new medicines to patients suffering from serious diseases. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Maxillary overdentures supported by four or six implants in the anterior region: 5-year results from a randomized controlled trial.

Science.gov (United States)

Slot, Wim; Raghoebar, Gerry M; Cune, Marco S; Vissink, Arjan; Meijer, Henny J A

2016-12-01

To compare a four- and six-implant maxillary overdenture after an observation period of 5 years. Fifty subjects with functional problems concerning their maxillary denture, who had ample bone volume in the anterior region to place four or six implants, were included and randomly assigned to either group. Implant and overdenture survival, clinical performance, marginal bone loss and patient satisfaction were assessed. Forty-six patients completed the 5-year follow-up. One implant failed in the six implants group (99.2% survival) and none in the four implants group (100% survival). No overdentures had to be replaced during the observation period and the number of complications was limited. Clinical function was good, with no difference in clinical parameters between the groups. Mean marginal bone resorption was 0.50 ± 0.37 and 0.52 ± 0.43 mm in the four and six implant group respectively. In patients with functional complaints of their maxillary denture, bar-supported overdentures on four implants in the anterior maxillary region were not inferior to overdentures supported by six implants after 5 years of function. Implant survival and patient satisfaction were high, clinical parameters favourable, bone loss and complications to the denture were minor in both groups (Clinical trial registration number: NTR2969). © 2016 The Authors. Journal of Clinical Periodontology Published by John Wiley & Sons Ltd.

Effectiveness of internet-supported cognitive behavioral and chronobiological interventions and effect moderation by insomnia subtype: study protocol of a randomized controlled trial.

Science.gov (United States)

Dekker, Kim; Benjamins, Jeroen S; Van Straten, Annemieke; Hofman, Winni F; Van Someren, Eus J W

2015-07-04

DSM-V criteria for insomnia disorder are met by 6 to 10% of the adult population. Insomnia has severe consequences for health and society. One of the most common treatments provided by primary caregivers is pharmacological treatment, which is far from optimal and has not been recommended since a 2005 consensus report of the National Institutes of Health. The recommended treatment is Cognitive Behavioral Therapy for Insomnia. Effectiveness, however, is still limited. Only a few studies have evaluated the effectiveness of chronobiological treatments, including the timed application of bright light, physical activity and body warming. Another opportunity for optimization of treatment is based on the idea that the people suffering from insomnia most likely represent a heterogeneous mix of subtypes, with different underlying causes and expected treatment responses. The present study aims to evaluate the possibility for optimizing insomnia treatment along the principles of personalized and stratified medicine. It evaluates the following: 1. The relative effectiveness of internet-supported cognitive behavioral therapy, bright light, physical activity and body warming; 2. Whether the effectiveness of internet-supported cognitive behavioral therapy for insomnia can be augmented by simultaneous or prior application of bright light, physical activity and body warming; and 3. Whether the effectiveness of the interventions and their combination are moderated by the insomnia subtype. In a repeated measures, placebo-controlled, randomized clinical trial that included 160 people diagnosed with insomnia disorder, we are evaluating the relative effectiveness of 4 intervention weeks. Primary outcome is subjective sleep efficiency, quantified using a sleep diary. Secondary outcomes include other complaints of sleep and daytime functioning, health-related cost estimates and actigraphic objective sleep estimates. Compliance will be monitored both subjectively and objectively using

PP22. PROGRESSING RADIOTHERAPY-DRUG COMBINATIONS TOWARDS EARLY PHASE CLINICAL TRIALS

Science.gov (United States)

Jones, Dr Hazel; Stock, Dr Julie; Chalmers, Prof Anthony

2017-01-01

Abstract The Radiotherapy-Drug Combinations consortium (RaDCom) works with UK-based investigators to design and deliver high quality preclinical projects evaluating specific radiotherapy-drug combinations. We have several collaborations with industry, from in vitro projects to understand the novel agent in the context of radiobiology, through to preclinical studies that will generate data to support the development of radiotherapy combination trials. RaDCom facilitates the coordination of industry interactions, triage new proposals, monitor active projects, and engages with the radiotherapy community to promote collaboration and networking (via a capability map). The CRUK New Agents Committee Preclinical Combination Grant scheme provides one of the funding options for these studies, with the potential to feed into early phase clinical trials via the ECMC Combinations Alliance. RaDCom also supports broader radiotherapy research initiatives, by working to improve preclinical quality assurance and identifying a route to registration for radiotherapy-drug treatments. These activities will place the UK at the forefront of radiotherapy-drug preclinical research and provide a significant incentive for pharmaceutical companies to invest in this area and utilise the RaDCom network. Further information can be found on our webpage: http://ctrad.ncri.org.uk/research-support/radiation-drug-combinations-radcom Successful projects from RaDCom can then move into early phase combinations trials within the Combinations Alliance. The Combinations Alliance supports early phase combination studies in the UK via the ECMC (Experimental Cancer Medicine Centres) network. It focuses on translational research, and enables clinical project teams to work with disease experts to set up investigator led trials. The CRUK Centre of Drug Development (CDD) supports these studies with further management and coordination ensuring more robust timelines and delivery. The Combinations Alliance framework

Effect of nature-based sounds' intervention on agitation, anxiety, and stress in patients under mechanical ventilator support: a randomised controlled trial.

Science.gov (United States)

Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Zayeri, Farid; Vaismoradi, Mojtaba; Jasper, Melanie

2013-07-01

Few studies have been conducted to investigate the effect of nature-based sounds (N-BS) on agitation, anxiety level and physiological signs of stress in patients under mechanical ventilator support. Non-pharmacological nursing interventions such as N-BS can be less expensive and efficient ways to alleviate anxiety and adverse effects of sedative medications in patients under mechanical ventilator support. This study was conducted to identify the effect of the nature-based sounds' intervention on agitation, anxiety level and physiological stress responses in patients under mechanical ventilation support. A randomized placebo-controlled trial design was used to conduct this study. A total of 60 patients aged 18-65 years under mechanical ventilation support in an intensive care unit were randomly assigned to the control and experimental groups. The patients in the intervention group received 90 min of N-BS. Pleasant nature sounds were played to the patients using media players and headphones. Patients' physiological signs were taken immediately before the intervention and at the 30th, 60th, 90th minutes and 30 min after the procedure had finished. The physiological signs of stress assessed were heart rate, respiratory rate, and blood pressure. Data were collected over eight months from Oct 2011 to June 2012. Anxiety levels and agitation were assessed using the Faces Anxiety Scale and Richmond Agitation Sedation Scale, respectively. The experimental group had significantly lower systolic blood pressure, diastolic blood pressure, anxiety and agitation levels than the control group. These reductions increased progressively in the 30th, 60th, 90th minutes, and 30 min after the procedure had finished indicating a cumulative dose effect. N-BS can provide an effective method of decreasing potentially harmful physiological responses arising from anxiety in mechanically ventilated patients. Nurses can incorporate N-BS intervention as a non-pharmacologic intervention into the

Results of an Oncology Clinical Trial Nurse Role Delineation Study.

Science.gov (United States)

Purdom, Michelle A; Petersen, Sandra; Haas, Barbara K

2017-09-01

To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. Web-based cross-sectional survey.
. Online via Qualtrics.
. 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination.
. Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice.
. Self-reported frequency of 59 activities.
. The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model.
. An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics.
. This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

Clinical Trials

Medline Plus

Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial).

Science.gov (United States)

Anstey, Matthew H; Wibrow, Bradley; Thevathasan, Tharusan; Roberts, Brigit; Chhangani, Khushi; Ng, Pauline Yeung; Levine, Alexander; DiBiasio, Alan; Sarge, Todd; Eikermann, Matthias

2017-03-21

Patients admitted to intensive care units (ICU) are often treated with intravenous (IV) vasopressors. Persistent hypotension and dependence on IV vasopressors in otherwise resuscitated patients lead to delay in discharge from ICU. Midodrine is an oral alpha-1 adrenergic agonist approved for treatment of symptomatic orthostatic hypotension. This trial aims to evaluate whether oral administration of midodrine is an effective adjunct to standard therapy to reduce the duration of IV vasopressor treatment, and allow earlier discharge from ICU and hospital. The MIDAS trial is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial being conducted in the USA and Australia. We are targeting 120 patients. Adult patients admitted to the ICU who are resuscitated and otherwise stable on low dose IV vasopressors for at least 24 h will be considered for recruitment. Participants will be randomized to receive midodrine (20 mg) or placebo three times a day, in addition to standard care. The primary outcome is time (hours) from initiation of midodrine or placebo to discontinuation of IV vasopressors. Secondary outcomes include time (hours) from ICU admission to discharge readiness, ICU length of stay (LOS) (days), hospital LOS (days), rates of ICU readmission, and rates of adverse events related to midodrine administration. Midodrine is approved by the Food and Drug Administration (FDA) for the treatment of symptomatic orthostatic hypotension. In August 2010, FDA proposed to withdraw approval of midodrine because of lack of studies that verify the clinical benefit of the drug. We obtained Investigational New Drug (IND 113,330) approval to study its effects in critically ill patients who require IV vasopressors but are otherwise ready for discharge from the ICU. A pilot observational study in a cohort of surgical ICU patients showed that the rate of decline in vasopressor requirements increased after initiation of midodrine treatment. We

'The phone reminder is important, but will others get to know about my illness?' Patient perceptions of an mHealth antiretroviral treatment support intervention in the HIVIND trial in South India.

Science.gov (United States)

Rodrigues, Rashmi; Poongulali, S; Balaji, Kavitha; Atkins, Salla; Ashorn, Per; De Costa, Ayesha

2015-11-02

The recent explosion of mHealth applications in the area of HIV care has led to the development of mHealth interventions to support antiretroviral treatment adherence. Several of these interventions have been tested for effectiveness, but few studies have explored patient perspectives of such interventions. Exploring patient perspectives enhances the understanding of how an intervention works or why it does not. We therefore studied perceptions regarding an mHealth adherence intervention within the HIVIND trial in South India. The study was conducted at three clinics in South India. The intervention comprised an automated interactive voice response (IVR) call and a pictorial short messaging service (SMS), each delivered weekly. Sixteen purposively selected participants from the intervention arm in the HIVIND trial were interviewed. All participants had completed at least 84 weeks since enrollment in the trial. Perceptions on the usefulness and perceived benefits and risks of receiving the intervention were sought. The interviews were transcribed and analysed using the framework approach to qualitative data analysis. Despite varying perceptions of the intervention, most participants found it useful. The intervention was perceived as a sign of 'care' from the clinic. The IVR call was preferred to the SMS reminder. Two-way communication was preferred to automated calls. Participants also perceived a risk of unintentional disclosure of their HIV status and stigma thereof via the intervention and took initiatives to mitigate this risk. Targeting reminders at those with poor adherence and those in need of social support was suggested. mHealth adherence interventions go beyond their intended role to provide a sense of care and support to the recipient. Although automated interventions are impersonal, they could be a solution for scale up. Interventions that engage both the recipient and the healthcare provider have greater potential for success. Personalising m

Randomized clinical trial of implant-supported ceramic-ceramic and metal-ceramic fixed dental prostheses: preliminary results.

Science.gov (United States)

Esquivel-Upshaw, Josephine F; Clark, Arthur E; Shuster, Jonathan J; Anusavice, Kenneth J

2014-02-01

The aim of this study was to determine the survival rates over time of implant-supported ceramic-ceramic and metal-ceramic prostheses as a function of core-veneer thickness ratio, gingival connector embrasure design, and connector height. An IRB-approved, randomized, controlled clinical trial was conducted as a single-blind pilot study involving 55 patients missing three teeth in either one or two posterior areas. These patients (34 women; 21 men; age range 52-75 years) were recruited for the study to receive a three-unit implant-supported fixed dental prosthesis (FDP). Two implants were placed for each of the 72 FDPs in the study. The implants (Osseospeed, Astra Tech), which were made of titanium, were grit blasted. A gold-shaded, custom-milled titanium abutment (Atlantis, Astra Tech), was secured to each implant body. Each of the 72 FDPs in 55 patients were randomly assigned based on one of the following options: (1) A. ceramic-ceramic (Yttria-stabilized zirconia core, pressable fluorapatite glass-ceramic, IPS e.max ZirCAD, and ZirPress, Ivoclar Vivadent) B. metal-ceramic (palladium-based noble alloy, Capricorn, Ivoclar Vivadent, with press-on leucite-reinforced glass-ceramic veneer, IPS InLine POM, Ivoclar Vivadent); (2) occlusal veneer thickness (0.5, 1.0, and 1.5 mm); (3) curvature of gingival embrasure (0.25, 0.5, and 0.75 mm diameter); and (4) connector height (3, 4, and 5 mm). FDPs were fabricated and cemented with dual-cure resin cement (RelyX, Universal Cement, 3M ESPE). Patients were recalled at 6 months, 1 year, and 2 years. FDPs were examined for cracks, fracture, and general surface quality. Recall exams of 72 prostheses revealed 10 chipping fractures. No fractures occurred within the connector or embrasure areas. Two-sided Fisher's exact tests showed no significant correlation between fractures and type of material system (p = 0.51), veneer thickness (p = 0.75), radius of curvature of gingival embrasure (p = 0.68), and connector height (p = 0

Patient representatives' views on patient information in clinical cancer trials.

Science.gov (United States)

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-02-01

Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

Science.gov (United States)

Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-12-05

To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track

Cluster randomized controlled trial of a peer support program for people with diabetes

DEFF Research Database (Denmark)

Riddell, Michaela A; Renwick, Carla; Wolfe, Rory

2012-01-01

ABSTRACT: BACKGROUND: Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional...... and social support, assist and encourage clinical care and be available when needed. METHODS: A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self......-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support...

The effect of financial incentives on top of behavioral support on quit rates in tobacco smoking employees: study protocol of a cluster-randomized trial.

Science.gov (United States)

van den Brand, F A; Nagelhout, G E; Winkens, B; Evers, S M A A; Kotz, D; Chavannes, N H; van Schayck, C P

2016-10-06

Stimulating successful tobacco cessation among employees has multiple benefits. Employees who quit tobacco are healthier, more productive, less absent from work, and longer employable than employees who continue to use tobacco. Despite the evidence for these benefits of tobacco cessation, a successful method to stimulate employees to quit tobacco is lacking. The aim of this study is to evaluate whether adding a financial incentive to behavioral support (compared with no additional incentive) is effective and cost-effective in increasing abstinence rates in tobacco smoking employees participating in a smoking cessation group training. In this cluster-randomized trial employees in the intervention and control group both participate in a smoking cessation group training consisting of seven weekly counseling sessions of ninety minutes each. In addition to the training, employees in the intervention group receive a voucher as an incentive for being abstinent from smoking at the end of the training (€50), after three months (€50), after six months (€50), and after one year (€200). The control group does not receive any incentive. The primary outcome is carbon monoxide validated 12-month continuous abstinence from smoking (Russel's standard). Additionally, an economic evaluation is performed from a societal and an employer perspective. The present paper describes the methods and design of this cluster-randomized trial in detail. We hypothesize that the financial incentive for abstinence in the form of vouchers increases abstinence rates over and above the group training. The results of this study can provide important recommendations for enhancement of employee tobacco cessation. Dutch Trial Register: NTR5657 . First received 27-01-2016.

A multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention in nursing homes: a two-armed randomized controlled trial.

Science.gov (United States)

Beeckman, Dimitri; Clays, Els; Van Hecke, Ann; Vanderwee, Katrien; Schoonhoven, Lisette; Verhaeghe, Sofie

2013-04-01

Frail older people admitted to nursing homes are at risk of a range of adverse outcomes, including pressure ulcers. Clinical decision support systems are believed to have the potential to improve care and to change the behaviour of healthcare professionals. To determine whether a multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention improves adherence to recommendations for pressure ulcer prevention in nursing homes. Two-armed randomized controlled trial in a nursing home setting in Belgium. The trial consisted of a 16-week implementation intervention between February and June 2010, including one baseline, four intermediate, and one post-testing measurement. Primary outcome was the adherence to guideline-based care recommendations (in terms of allocating adequate pressure ulcer prevention in residents at risk). Secondary outcomes were the change in resident outcomes (pressure ulcer prevalence) and intermediate outcomes (knowledge and attitudes of healthcare professionals). Random sample of 11 wards (6 experimental; 5 control) in a convenience sample of 4 nursing homes in Belgium. In total, 464 nursing home residents and 118 healthcare professionals participated. The experimental arm was involved in a multi-faceted tailored implementation intervention of a clinical decision support system, including interactive education, reminders, monitoring, feedback and leadership. The control arm received a hard-copy of the pressure ulcer prevention protocol, supported by standardized 30 min group lecture. Patients in the intervention arm were significantly more likely to receive fully adequate pressure ulcer prevention when seated in a chair (F=16.4, P=0.003). No significant improvement was observed on pressure ulcer prevalence and knowledge of the professionals. While baseline attitude scores were comparable between both groups [exp. 74.3% vs. contr. 74.5% (P=0.92)], the mean score after the intervention was

Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial.

Science.gov (United States)

Nelson, Lyndsay A; Wallston, Kenneth A; Kripalani, Sunil; Greevy, Robert A; Elasy, Tom A; Bergner, Erin M; Gentry, Chad K; Mayberry, Lindsay S

2018-04-10

Nonadherence to self-care is common among patients with type 2 diabetes (T2D) and often leads to severe complications. Moreover, patients with T2D who have low socioeconomic status and are racial/ethnic minorities disproportionately experience barriers to adherence and poor outcomes. Basic phone technology (text messages and phone calls) provides a practical medium for delivering content to address patients' barriers to adherence; however, trials are needed to explore long-term and sustainable effects of mobile phone interventions among diverse patients. The aim of this study is to evaluate the effects of mobile phone-based diabetes support interventions on self-care and hemoglobin A 1c (HbA 1c ) among adults with T2D using a 3-arm, 15-month randomized controlled trial with a Type 1 hybrid effectiveness-implementation approach. The intervention arms are (1) Rapid Encouragement/Education And Communications for Health (REACH) and (2) REACH + Family-focused Add-on for Motivating Self-care (FAMS). We recruited primary care patients with T2D (N=512) from Federally Qualified Health Centers and an academic medical center, prioritizing recruitment of publicly insured and minority patients from the latter. Eligible patients were prescribed daily diabetes medication and owned a cell phone with text messaging capability. We excluded patients whose most recent HbA 1c result within 12 months was phone coaching with related text message content focused on family and friend barriers to diet and exercise adherence. We collect HbA 1c and self-reported survey data at baseline and at 3, 6, and 12 months, and again at 15 months to assess sustained changes. We will use generalized estimating equation models to test the effects of REACH (either intervention arm) on HbA 1c relative to the control group, the potential additive effects of FAMS, and effects of either intervention on adherence to self-care behaviors and diabetes self-efficacy. The trial is ongoing; recruitment closed

Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Stevanovic, Ana; Beckers, Stefan Kurt; Czaplik, Michael; Bergrath, Sebastian; Coburn, Mark; Brokmann, Jörg Christian; Hilgers, Ralf-Dieter; Rossaint, Rolf

2017-01-26

Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment. Three thousand and ten patients will be included in this single-center, open-label, randomized controlled, noninferiority trial with two parallel arms. According to the inclusion criteria, all emergency cases involving adult patients who require EMS-physician treatment, excluding life-threatening cases, will be randomly assigned by the EMS dispatching center into two groups. One thousand five hundred and five patients in the control group will be treated by a conventional EMS physician on scene, and 1505 patients in the intervention group will be treated by paramedics who are concurrently instructed by the tele-EMS physicians at the teleconsultation center. The primary outcome measure will include the rate of treatment-specific adverse events in relation to the kind of EMS physician used. The secondary outcome measures will record the specific treatment-associated quality indicators. The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical

Walking the talk: the need for a trial registry for development interventions

DEFF Research Database (Denmark)

Rasmussen, Ole Dahl; Malchow-Møller, Nikolaj; Andersen, Thomas Barnebeck

2011-01-01

Recent advances in the use of randomised control trials to evaluate the effect of development interventions promise to enhance our knowledge of what works and why. A core argument supporting randomised studies is the claim that they have high internal validity. The authors argue that this claim...... is weak as long as a trial registry of development interventions is not in place. Without a trial registry, the possibilities for data mining, created by analyses of multiple outcomes and subgroups, undermine internal validity. Drawing on experience from evidence-based medicine and recent examples from...

The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

Directory of Open Access Journals (Sweden)

Campbell Karen

2008-03-01

Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

Group Cognitive-Behavior Therapy and Supportive Art and Sport Interventions on Bam Earthquake Related Post Traumatic Stress Symptoms in Children: A Field Trial

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Narges Joshaghani

2009-12-01

Full Text Available "n Objective: "n "nThe main objective of this study is to evaluate the effect of psychological therapies and art/sport supportive interventions separately,and in combination on post traumatic stress symptoms in children and compare them with a control group . "nMethods: In a field trial, we evaluated the efficacy of group behavioral therapy, art and sport supportive interventions in Bam earthquake children survivors with PTSD symptoms and compared it with a control group. Before and after interventions we evaluated the PTSD symptoms using K-SADS-PL semi-structural interview for each group and compared them using appropriate statistical methods. "nResults: The participants were 200 individuals who were randomized in four groups according to an intervention program including: Group behavioral therapy; Group behavioral therapy plus art and sport interventions; Art and sport interventions; and control group. During the interventions, 39 individuals were excluded. None of the participants had severed PTSD or other psychiatry disorders that needed pharmacological interventions. In interventional groups, the reduction of total PTSD symptoms and the symptoms of re-experience, avoidance and hyper arousal was not statistically significant. However, in the control group, the PTSD symptoms increased during the study which was statistically significant. "nConclusion: Group behavior therapy and supportive interventions (art and sport may have preventive effects on PTSD symptoms.

Arthroskopische Behandlung von Knorpelverletzungen am Sprunggelenk

DEFF Research Database (Denmark)

Thomas, M.; Jordan, J M; Hamborg-Petersen, E

2016-01-01

Ankle sprains are the most relevant injuries of the lower extremities and can lead to damage to ligaments and osteochondral lesions. Up to 50 % of patients with a sprained ankle later develop a lesion of the cartilage in the ankle joint or an osteochondral lesion of the talus. This can lead...... to osteoarthritis of the injured ankle joint. Spontaneous healing is possible in all age groups in cases of a bone bruise in the subchondral bone but in isolated chondral injuries is only useful in pediatric patients. In many cases chondral and osteochondral injuries lead to increasing demarcation of the affected...

Die Behandlung menschliches Embryos und Menschenwurde

OpenAIRE

Matsui, Fumio

2002-01-01

We are confronted with an old and new problem, which has come up with the progress of modern biotechnologies: what is a life or when does a life begin? The expectation of order-made medicine has build up since the discovery of Embryo Stem cell called "a dream master cell", while there is any condemnation against the destruction of human embryo in order to gain it. It is a question whether a human embryo is a human being in the world. Human dignity(=HD) is a principle that keeps human embryos ...

Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Arabi, Yaseen M; Alothman, Adel; Balkhy, Hanan H; Al-Dawood, Abdulaziz; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M; Assiri, Abdullah M; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Almekhlafi, Ghaleb A; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Memon, Javed; Taha, Yusri; Almotairi, Abdullah; Maghrabi, Khalid A; Qushmaq, Ismael; Al Bshabshe, Ali; Kharaba, Ayman; Shalhoub, Sarah; Jose, Jesna; Fowler, Robert A; Hayden, Frederick G; Hussein, Mohamed A

2018-01-30

It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

Sharing and reuse of individual participant data from clinical trials: principles and recommendations.

Science.gov (United States)

Ohmann, Christian; Banzi, Rita; Canham, Steve; Battaglia, Serena; Matei, Mihaela; Ariyo, Christopher; Becnel, Lauren; Bierer, Barbara; Bowers, Sarion; Clivio, Luca; Dias, Monica; Druml, Christiane; Faure, Hélène; Fenner, Martin; Galvez, Jose; Ghersi, Davina; Gluud, Christian; Groves, Trish; Houston, Paul; Karam, Ghassan; Kalra, Dipak; Knowles, Rachel L; Krleža-Jerić, Karmela; Kubiak, Christine; Kuchinke, Wolfgang; Kush, Rebecca; Lukkarinen, Ari; Marques, Pedro Silverio; Newbigging, Andrew; O'Callaghan, Jennifer; Ravaud, Philippe; Schlünder, Irene; Shanahan, Daniel; Sitter, Helmut; Spalding, Dylan; Tudur-Smith, Catrin; van Reusel, Peter; van Veen, Evert-Ben; Visser, Gerben Rienk; Wilson, Julia; Demotes-Mainard, Jacques

2017-12-14

We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. We developed principles and practical recommendations on how to share data from clinical trials. The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata. The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and

A trial assessing N-3 as treatment for injury-induced cachexia (ATLANTIC trial: does a moderate dose fish oil intervention improve outcomes in older adults recovering from hip fracture?

Directory of Open Access Journals (Sweden)

Cleland Leslie

2010-10-01

Full Text Available Abstract Background Proximal femoral fractures are associated with increased morbidity and mortality. Pre-existing malnutrition and weight loss amongst this patient group is of primary concern, with conventional nutrition support being largely ineffective. The inflammatory response post proximal femoral fracture surgery and the subsequent risk of cachexia may explain the inability of conventional high energy high protein management to produce an anabolic response amongst these patients. Omega-3 fatty acids derived from fish oils have been extensively studied for their anti-inflammatory benefits. Due to their anti-inflammatory properties, the benefit of fish oil combined with individualized nutrition support amongst proximal femoral fracture patients post surgery is an attractive potential therapeutic strategy. The aim of the ATLANTIC trial is to assess the potential benefits of an anti-inflammatory dose of fish oil within the context of a 12 week individualised nutrition program, commencing seven days post proximal femoral fracture surgery. Methods/Design This randomized controlled, double blinded trial, will recruit 150 community dwelling elderly patients aged ≥65 years, within seven days of surgery for proximal femoral fracture. Participants will be randomly allocated to receive either a 12 week individualized nutrition support program complemented with 20 ml/day anti-inflammatory dose fish oil (~3.6 g eicosapentaenoic acid, ~2.4 g docosahexanoic acid; intervention, or, a 12 week individualized nutrition support program complemented with 20 ml/day low dose fish oil (~0.36 g eicosapentaenoic acid, ~0.24 g docosahexanoic acid; control. Discussion The ATLANTIC trial is the first of its kind to provide fish oil combined with individualized nutrition therapy as an intervention to address the inflammatory response experienced post proximal femoral fracture surgery amongst elderly patients. The final outcomes of this trial will assist clinicians in

CONDUCTING A TRIAL OF WEB CONFERENCING SOFTWARE: Why, How, and Perceptions from the Coalface

Directory of Open Access Journals (Sweden)

Shirley REUSHLE

2008-07-01

Full Text Available ABSTRACT This paper reports on the trial of web conferencing software conducted at a regional Australian university with a significant distance population. The paper shares preliminary findings, the views of participants and recommendations for future activity. To design and conduct the trial, an action research method was chosen because it is participative and grounded in experience, reflecting the context and objectives of the trial. In the first phase of the trial, students in postgraduate Education courses were linked across the globe to participate in interactive and collaborative conference activity and to communicate via audio, text, and video and shared whiteboard. Mathematical problem-solving was carried out collaboratively in an undergraduate course using tablet PCs. This was followed by phase 2, a university-wide trial across disciplines. Preliminary findings indicate that web conferencing software enables teachers and students at the university to engage actively across diverse locations, supporting a student-centred approach and greater flexibility in terms of where, when and how students learn. From these findings, the authors have made some initial recommendations to university management on the adoption of web conferencing to support learning and teaching.

Internet trials: participant experiences and perspectives

Science.gov (United States)

2012-01-01

confidentiality issues; perceived benefits and disadvantages for researchers; technical aspects of using the Internet; and the impact of Internet data collection on information quality. Overall, more advantages were noted by participants, consistent with their preference for this mode of research over others. The majority of participants (69%) would prefer to participate in Internet-based research compared to other modes of data collection in the future. Conclusion Participants in our survey would prefer to participate in Internet-based trials in the future compared to other ways of conducting trials. From the participants’ perspective, participating in Internet-based trials involves trade-offs. The central trade-off is between flexibility and convenience – a perceived benefit – and lack of connectedness and understanding – a perceived disadvantage. Strategies to maintain the convenience of the Internet while increasing opportunities for participants to feel supported, well-informed and well-understood would seem likely to increase the acceptability of Internet-based trials. PMID:23092116

Internet trials: participant experiences and perspectives