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Sample records for examination trial study

  1. 'Rumours' and clinical trials: a retrospective examination of a paediatric malnutrition study in Zambia, southern Africa

    Directory of Open Access Journals (Sweden)

    Amadi Beatrice

    2010-09-01

    Full Text Available Abstract Background Many public health researchers conducting studies in resource-constrained settings have experienced negative 'rumours' about their work; in some cases they have been reported to create serious challenges and derail studies. However, what may appear superficially as 'gossip' or 'rumours' can also be regarded and understood as metaphors which represent local concerns. For researchers unaccustomed to having concerns expressed from participants in this manner, possible reactions can be to be unduly perturbed or conversely dismissive. This paper represents a retrospective examination of a malnutrition study conducted by an international team of researchers in Zambia, Southern Africa. The fears of mothers whose children were involved in the study and some of the concerns which were expressed as rumours are also presented. This paper argues that there is an underlying logic to these anxieties and to dismiss them simply as 'rumours' or 'gossip' would be to overlook the historic and socio-economic factors which have contributed to their production. Methods Qualitative interviews were conducted with the mothers whose children were involved in the study and with the research nurses. Twenty five face-to-face interviews and 2 focus group discussions (FGDs were conducted with mothers. In addition, face-to-face interviews were conducted with research nurses participating in the trial. Results A prominent anxiety expressed as rumours by the mothers whose children were involved in the study was that recruitment into the trial was an indicator that the child was HIV-infected. Other anxieties included that the trial was a disguise for witchcraft or Satanism and that the children's body parts would be removed and sold. In addition, the liquid, milk-based food given to the children to improve their nutrition was suspected of being insufficiently nutritious, thus worsening their condition. The form which these anxieties took, such as rumours

  2. A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

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    Sternlieb Beth

    2011-01-01

    Full Text Available Abstract Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823

  3. Shedding light on research participation effects in behaviour change trials: a qualitative study examining research participant experiences

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    Virginia MacNeill

    2016-01-01

    Full Text Available Abstract Background The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants’ experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes Methods Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach. Results The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants’ relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes. Conclusion These

  4. Shedding light on research participation effects in behaviour change trials: a qualitative study examining research participant experiences.

    Science.gov (United States)

    MacNeill, Virginia; Foley, Marian; Quirk, Alan; McCambridge, Jim

    2016-01-29

    The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants' experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption) and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach. The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants' relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes. These participants described no dramatic impacts attributable to taking part in

  5. Examination of mechanisms (E-MECHANIC) of exercise-induced weight compensation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Myers, Candice A; Johnson, William D; Earnest, Conrad P; Rood, Jennifer C; Tudor-Locke, Catrine; Johannsen, Neil M; Cocreham, Shannon; Harris, Melissa; Church, Timothy S; Martin, Corby K

    2014-06-07

    Weight loss induced only by exercise is frequently less than expected, possibly because of compensatory changes in energy intake and/or energy expenditure. The purpose of the Examination of Mechanisms (E-MECHANIC) of Exercise-Induced Weight Compensation trial is to examine whether increased energy intake and/or reduced spontaneous activity or energy expenditure (outside of structured exercise) account for the less than expected, exercise-associated weight loss. E-MECHANIC is a three-arm, 6-month randomized (1:1:1) controlled trial. The two intervention arms are exercise doses that reflect current recommendations for (1) general health (8 kcal/kg body weight per week (8 KKW), about 900 kcal/wk) and (2) weight loss (20 KKW, about 2,250 kcal/wk). The third arm, a nonexercise control group, will receive health information only. The sample will include a combined total of 198sedentary, overweight or obese (body mass index: ≥25 kg/m² to ≤45 kg/m²) men and women ages 18 to 65 years. The exercise dose will be supervised and tightly controlled in an exercise training laboratory. The primary outcome variables are energy intake, which will be measured using doubly labeled water (adjusted for change in energy stores) and laboratory-based food intake tests, and the discrepancy between expected weight loss and observed weight loss. Secondary outcomes include changes in resting metabolic rate (adjusted for change in body mass), activity levels (excluding structured exercise) and body composition. In an effort to guide the development of future interventions, the participants will be behaviorally phenotyped and defined as those who do compensate (that is, fail to lose the amount of weight expected) or do not compensate (that is, lose the amount of weight expected or more). In this study, we will attempt to identify underlying mechanisms to explain why exercise elicits less weight loss than expected. This information will guide the development of interventions to increase

  6. The ExPeCT (Examining Exercise, Prostate Cancer and Circulating Tumour Cells) trial: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Sheill, Gráinne; Brady, Lauren; Guinan, Emer; Hayes, Brian; Casey, Orla; Greene, John; Vlajnic, Tatjana; Cahill, Fidelma; Van Hemelrijck, Mieke; Peat, Nicola; Rudman, Sarah; Hussey, Juliette; Cunningham, Moya; Grogan, Liam; Lynch, Thomas; Manecksha, Rustom P; McCaffrey, John; Mucci, Lorelei; Sheils, Orla; O'Leary, John; O'Donnell, Dearbhaile M; McDermott, Ray; Finn, Stephen

    2017-10-04

    Prostate cancer (PrCa) is the second most common cancer in Ireland. Many men present with locally advanced or metastatic cancer for whom curative surgery is inappropriate. Advanced cancer patients are encouraged to remain physically active and therefore there is a need to investigate how patients with metastatic disease tolerate physical activity programmes. Physical activity reduces levels of systemic inflammatory mediators and so an aerobic exercise intervention may represent an accessible and cost-effective means of ameliorating the pro-inflammatory effects of obesity and subsequently decrease poor cancer-specific outcomes in this patient population. This study will assess the feasibility and safety of introducing a structured aerobic exercise intervention to an advanced cancer population. This study will also examine if the evasion of immune editing by circulating tumour cells (CTCs) is an exercise-modifiable mechanism in obese men with prostate cancer. This international multicentre prospective study will recruit men with metastatic prostate cancer. Participants will be recruited from centres in Dublin (Ireland) and London (UK). Participants will be divided into exposed and non-exposed groups based on body mass index (BMI) ≥ 25 kg/m 2 and randomised to intervention and control groups. The exercise group will undertake a regular supervised aerobic exercise programme, whereas the control group will not. Exercise intensity will be prescribed based on a target heart rate monitored by a polar heart rate monitor. Blood samples will be taken at recruitment and at 3 and 6 months to examine the primary endpoint of platelet cloaking of CTCs. Participants will complete a detailed questionnaire to assess quality of life (QoL) and other parameters at each visit. The overall aim of the ExPeCT trial is to examine the relationship between PrCa, exercise, obesity, and systemic inflammation, and to improve the overall QoL in men with advanced disease. Results will

  7. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Voils Corrine I

    2012-08-01

    Full Text Available Abstract Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT01060540

  8. The Certificate of Secondary Education Trial Examinations: Handicraft.

    Science.gov (United States)

    Schools Council, London (England).

    These trial examinations in handicrafts for certification in secondary education in England are similar to previously published trial examinations in religious knowledge, experimental exams, and the place of the personal topic in history. Half of the booklet deals with (1) the trial examination's history and description, (2) details of the…

  9. (Sample) size matters! An examination of sample size from the SPRINT trial study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures

    NARCIS (Netherlands)

    Bhandari, Mohit; Tornetta, Paul; Rampersad, Shelly-Ann; Sprague, Sheila; Heels-Ansdell, Diane; Sanders, David W.; Schemitsch, Emil H.; Swiontkowski, Marc; Walter, Stephen; Guyatt, Gordon; Buckingham, Lisa; Leece, Pamela; Viveiros, Helena; Mignott, Tashay; Ansell, Natalie; Sidorkewicz, Natalie; Agel, Julie; Bombardier, Claire; Berlin, Jesse A.; Bosse, Michael; Browner, Bruce; Gillespie, Brenda; O'Brien, Peter; Poolman, Rudolf; Macleod, Mark D.; Carey, Timothy; Leitch, Kellie; Bailey, Stuart; Gurr, Kevin; Konito, Ken; Bartha, Charlene; Low, Isolina; MacBean, Leila V.; Ramu, Mala; Reiber, Susan; Strapp, Ruth; Tieszer, Christina; Kreder, Hans; Stephen, David J. G.; Axelrod, Terry S.; Yee, Albert J. M.; Richards, Robin R.; Finkelstein, Joel; Holtby, Richard M.; Cameron, Hugh; Cameron, John; Gofton, Wade; Murnaghan, John; Schatztker, Joseph; Bulmer, Beverly; Conlan, Lisa; Laflamme, Yves; Berry, Gregory; Beaumont, Pierre; Ranger, Pierre; Laflamme, Georges-Henri; Jodoin, Alain; Renaud, Eric; Gagnon, Sylvain; Maurais, Gilles; Malo, Michel; Fernandes, Julio; Latendresse, Kim; Poirier, Marie-France; Daigneault, Gina; McKee, Michael M.; Waddell, James P.; Bogoch, Earl R.; Daniels, Timothy R.; McBroom, Robert R.; Vicente, Milena R.; Storey, Wendy; Wild, Lisa M.; McCormack, Robert; Perey, Bertrand; Goetz, Thomas J.; Pate, Graham; Penner, Murray J.; Panagiotopoulos, Kostas; Pirani, Shafique; Dommisse, Ian G.; Loomer, Richard L.; Stone, Trevor; Moon, Karyn; Zomar, Mauri; Webb, Lawrence X.; Teasdall, Robert D.; Birkedal, John Peter; Martin, David Franklin; Ruch, David S.; Kilgus, Douglas J.; Pollock, David C.; Harris, Mitchel Brion; Wiesler, Ethan Ron; Ward, William G.; Shilt, Jeffrey Scott; Koman, Andrew L.; Poehling, Gary G.; Kulp, Brenda; Creevy, William R.; Stein, Andrew B.; Bono, Christopher T.; Einhorn, Thomas A.; Brown, T. Desmond; Pacicca, Donna; Sledge, John B.; Foster, Timothy E.; Voloshin, Ilva; Bolton, Jill; Carlisle, Hope; Shaughnessy, Lisa; Ombremsky, William T.; LeCroy, C. Michael; Meinberg, Eric G.; Messer, Terry M.; Craig, William L.; Dirschl, Douglas R.; Caudle, Robert; Harris, Tim; Elhert, Kurt; Hage, William; Jones, Robert; Piedrahita, Luis; Schricker, Paul O.; Driver, Robin; Godwin, Jean; Hansley, Gloria; Obremskey, William Todd; Kregor, Philip James; Tennent, Gregory; Truchan, Lisa M.; Sciadini, Marcus; Shuler, Franklin D.; Driver, Robin E.; Nading, Mary Alice; Neiderstadt, Jacky; Vap, Alexander R.; Vallier, Heather A.; Patterson, Brendan M.; Wilber, John H.; Wilber, Roger G.; Sontich, John K.; Moore, Timothy Alan; Brady, Drew; Cooperman, Daniel R.; Davis, John A.; Cureton, Beth Ann; Mandel, Scott; Orr, R. Douglas; Sadler, John T. S.; Hussain, Tousief; Rajaratnam, Krishan; Petrisor, Bradley; Drew, Brian; Bednar, Drew A.; Kwok, Desmond C. H.; Pettit, Shirley; Hancock, Jill; Cole, Peter A.; Smith, Joel J.; Brown, Gregory A.; Lange, Thomas A.; Stark, John G.; Levy, Bruce; Swiontkowski, Marc F.; Garaghty, Mary J.; Salzman, Joshua G.; Schutte, Carol A.; Tastad, Linda Toddie; Vang, Sandy; Seligson, David; Roberts, Craig S.; Malkani, Arthur L.; Sanders, Laura; Gregory, Sharon Allen; Dyer, Carmen; Heinsen, Jessica; Smith, Langan; Madanagopal, Sudhakar; Coupe, Kevin J.; Tucker, Jeffrey J.; Criswell, Allen R.; Buckle, Rosemary; Rechter, Alan Jeffrey; Sheth, Dhiren Shaskikant; Urquart, Brad; Trotscher, Thea; Anders, Mark J.; Kowalski, Joseph M.; Fineberg, Marc S.; Bone, Lawrence B.; Phillips, Matthew J.; Rohrbacher, Bernard; Stegemann, Philip; Mihalko, William M.; Buyea, Cathy; Augustine, Stephen J.; Jackson, William Thomas; Solis, Gregory; Ero, Sunday U.; Segina, Daniel N.; Berrey, Hudson B.; Agnew, Samuel G.; Fitzpatrick, Michael; Campbell, Lakina C.; Derting, Lynn; McAdams, June; Goslings, J. Carel; Ponsen, Kees Jan; Luitse, Jan; Kloen, Peter; Joosse, Pieter; Winkelhagen, Jasper; Duivenvoorden, Raphaël; Teague, David C.; Davey, Joseph; Sullivan, J. Andy; Ertl, William J. J.; Puckett, Timothy A.; Pasque, Charles B.; Tompkins, John F.; Gruel, Curtis R.; Kammerlocher, Paul; Lehman, Thomas P.; Puffinbarger, William R.; Carl, Kathy L.; Weber, Donald W.; Jomha, Nadr M.; Goplen, Gordon R.; Masson, Edward; Beaupre, Lauren A.; Greaves, Karen E.; Schaump, Lori N.; Jeray, Kyle J.; Goetz, David R.; Westberry, Davd E.; Broderick, J. Scott; Moon, Bryan S.; Tanner, Stephanie L.; Powell, James N.; Buckley, Richard E.; Elves, Leslie; Connolly, Stephen; Abraham, Edward P.; Eastwood, Donna; Steele, Trudy; Ellis, Thomas; Herzberg, Alex; Brown, George A.; Crawford, Dennis E.; Hart, Robert; Hayden, James; Orfaly, Robert M.; Vigland, Theodore; Vivekaraj, Maharani; Bundy, Gina L.; Miclau, Theodore; Matityahu, Amir; Coughlin, R. Richard; Kandemir, Utku; McClellan, R. Trigg; Lin, Cindy Hsin-Hua; Karges, David; Cramer, Kathryn; Watson, J. Tracy; Moed, Berton; Scott, Barbara; Beck, Dennis J.; Orth, Carolyn; Puskas, David; Clark, Russell; Jones, Jennifer; Egol, Kenneth A.; Paksima, Nader; France, Monet; Wai, Eugene K.; Johnson, Garth; Wilkinson, Ross; Gruszczynski, Adam T.; Vexler, Liisa

    2013-01-01

    Inadequate sample size and power in randomized trials can result in misleading findings. This study demonstrates the effect of sample size in a large clinical trial by evaluating the results of the Study to Prospectively evaluate Reamed Intramedullary Nails in Patients with Tibial fractures (SPRINT)

  10. WWC Review of the Report "A Randomized Trial Examining the Effects of Aerobic Physical Activity on Attention-Deficit/Hyperactivity Disorder Symptoms in Young Children." What Works Clearinghouse Single Study Review

    Science.gov (United States)

    What Works Clearinghouse, 2015

    2015-01-01

    For the 2014 study, "A Randomized Trial Examining the Effects of Aerobic Physical Activity on Attention-Deficit/Hyperactivity Disorder Symptoms in Young Children", researchers examined the effect of a daily before-school physical activity program on behavioral outcomes of students in grades K-2. The study sample included 202 students who…

  11. A randomized controlled trial examining the effectiveness of a STOMA psychosocial intervention programme on the outcomes of colorectal patients with a stoma: study protocol.

    Science.gov (United States)

    Lim, Siew Hoon; Chan, Sally Wai-Chi; Lai, Jiunn Herng; He, Hong-Gu

    2015-06-01

    To report a study protocol that evaluates the effects of a psychosocial intervention on patients with a newly formed stoma. With the loss of a significant body function and distorted body image, stoma patients experience physical, psychological and social challenges. Nurses have an important role in helping patients' make a smooth transition to living with their stoma. Limited studies have examined the effects of psychosocial interventions on improving stoma-related health outcomes. A randomized controlled trial is planned. Eighty-four patients with newly formed stoma in a tertiary hospital in Singapore (Research Ethics Committee approval obtained in January 2013) will be recruited. Participants will be randomly assigned to either a control group who receive routine care or an intervention group who receive STOMA psychosocial intervention besides routine care. Outcome variables include stoma care self-efficacy, days to stoma proficiency, length of hospital stay, acceptance of stoma, anxiety and depression and quality of life. Data will be collected at four time points: before randomization and intervention (baseline), on the day of discharge (mid-intervention), at 4 weeks after discharge (postintervention 1) and at 4 months after discharge (postintervention 2). This study will develop a psychosocial intervention programme, which may improve patients' stoma-related outcomes. The findings will provide direction to health professionals about education and the type of support that could be offered to patients concerning stoma care in the hospital setting, which will eventually improve their quality of life. © 2014 John Wiley & Sons Ltd.

  12. A feasibility study of a randomised controlled trial to examine the impact of the ABCDE bundle on quality of life in ICU survivors.

    Science.gov (United States)

    Sosnowski, Kellie; Mitchell, Marion L; White, Hayden; Morrison, Lynette; Sutton, Joanne; Sharratt, Jessica; Lin, Frances

    2018-01-01

    Early rehabilitation has been found to prevent delirium and weakness that can hamper the recovery of intensive care unit (ICU) survivors. Integrated clinical practice guidelines for managing patient pain, agitation and delirium (PAD) have been developed. The Awakening and Breathing Coordination, Delirium monitoring/management, and Early exercise/mobility (ABCDE) bundle provides a strategy to implement PAD guidelines into everyday clinical practice. However, there is limited evidence on the effectiveness of the ABCDE bundle in the literature.The purpose of this study was to evaluate the feasibility of conducting a full-scale randomised controlled trial comparing the ABCDE bundle to standard care in an ICU. Trial feasibility was defined as the successful recruitment and retention of trial participants, adherence to the intervention, identification of barriers to the intervention, and the rigorous collection of outcome data. A prospective, single-centre, randomised controlled feasibility study was conducted. Thirty adult mechanically ventilated participants were recruited from an eight-bed ICU in south east Queensland, Australia, between April 2015 and December 2015. Participants were randomised to receive either the ABCDE bundle or standard routine management. The ABCDE bundle integrated prescribed awakening and breathing trials, delirium monitoring and management, and prescribed exercise and mobility regimes. Feasibility outcomes measured included recruitment and retention rates, intervention fidelity, and the feasibility of participant outcome data collection. Outcome measurement assessors were blinded to participant assignment. It was not possible to blind the research team or the participant to group assignment. In total, 30 (81.1%) of 37 eligible participants consented and were randomised to the intervention group ( n  = 15) or the control group ( n  = 15). Of these, 23 (76.6%) participants successfully completed the 90-day post discharge assessment. A

  13. Pilot feasibility and safety study examining the effect of medium chain triglyceride supplementation in subjects with mild cognitive impairment: A randomized controlled trial

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    Candida J. Rebello

    2015-06-01

    Conclusions: Consumption of 56 g/day of MCTs for 24 weeks increases serum ketone concentrations and appears to be a candidate for larger randomized control trials in the future that quantify the modulation of cognitive function through supplementation with ketone precursors, in patients with MCI.

  14. Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design

    DEFF Research Database (Denmark)

    Pfisterer, M.; Bertel, O.; Bonetti, P.O.

    2008-01-01

    Background Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitats Trial (BASKET) outcome data, we hypothesized that very late (>12 months) stent thrombosis occurs predominantly after drug-eluting stent implantation in large native coronary vessel stenting. Methods To prove...... or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with >= 3.0-mm stents only, randomized to receive Cypher (Johnson & Johnson, Miami Lakes, FL), Vision (Abbott Vascular, Abbott Laboratories, IL), or Xience stents (Abbott Vascular). Only...... to cobalt-chromium bare-metal stents in this relevant, low-risk group of everyday patients. In addition, a comparison with similar BASKET patients will allow to estimate the impact of 12-versus 6-month dual antiplatelet therapy on these outcomes Udgivelsesdato: 2008/4...

  15. The Role of Forensic Examination at Trials in China

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    Baosheng Zhang

    2015-01-01

    Full Text Available Expertise gains increasing acceptance and importance at trials in China. Currently, the forensic examination quality management system of China has been preliminarily established. There are problems, however, for example, laws and regulations related with forensic examination are not comprehensive, forensic institutes pursue their own economic profits excessively and judges sometime have undue blind faith in scientific evidence in fact-finding. These are hindering forensic examination from being put into full play duly. In 2005, the Decision of the Standing Committee of the National People's Congress on the Administration of Forensic Examination strengthened the neutrality of forensic institutes. The Criminal Procedure Law and the Civil Procedure Law revised in 2012 initially set up the expert assistant system, which is expected to break the excessively credulous but unjustified belief in scientific evidence and solve pertinent problems. We need to focus on the following aspects: First and foremost developing a unified set of rules on forensic examination; secondly, judges need to strengthen their own ability to review scientific evidence and determine its reliability; thirdly, we should actively promote fundamental legal education reform to remedy the insufficiency of legal understanding of forensic science; and finally, the existing expert assistant system must be further improved to help judges and litigants effectively to identify and use expertise.

  16. Effective dose assessment for participants in the National Lung Screening Trial undergoing posteroanterior chest radiographic examinations.

    Science.gov (United States)

    Kruger, Randell; Flynn, Michael J; Judy, Phillip F; Cagnon, Christopher H; Seibert, J Anthony

    2013-07-01

    The National Lung Screening Trial (NLST) is a multicenter randomized controlled trial comparing low-dose helical CT with chest radiography in the screening of older current and former heavy smokers for early detection of lung cancer. Recruitment was launched in September 2002 and ended in April 2004, when 53,454 participants had been randomized at 33 screening sites. The objective of this study was to determine the effective radiation dose associated with individual chest radiographic screening examinations. A total of 73,733 chest radiographic examinations were performed with 92 chest imaging systems. The entrance skin air kerma (ESAK) of participants' chest radiographic examinations was estimated and used in this analysis. The effective dose per ESAK for each examination was determined with a Monte Carlo-based program. The examination effective dose was calculated as the product of the examination ESAK and the Monte Carlo estimate of the ratio of effective dose per ESAK. This study showed that the mean effective dose assessed from 66,157 postero-anterior chest examinations was 0.052 mSv. Additional findings were a median effective dose of 0.038 mSv, a 95th percentile value of 0.136 mSv, and a fifth percentile value of 0.013 mSv. The effective dose for participant NLST chest radiographic examinations was determined and is of specific interest in relation to that associated with the previously published NLST low-dose CT examinations conducted during the trial.

  17. Examining the clinical trial feasibility process and its implications for a trial site

    Directory of Open Access Journals (Sweden)

    Burgess LJ

    2011-09-01

    Full Text Available LJ Burgess, NU SulzerTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow, South AfricaObjectives: To retrospectively analyze feasibility questionnaires to evaluate the number of trials that resulted in patient enrolment and the mean time frame involved.Methods: This study was conducted by TREAD Research, a site-managed organization based in the Western Cape, South Africa, between January 2004 and December 2009. All feasibility questionnaires received by the site over this time period were analyzed. Descriptive statistics were used to analyze the data.Results: A total of 252 feasibility questionnaires were received; 207 were accepted and 45 rejected. An average of 26.8% of trials started out of those feasibilities that were accepted by the site. The average time frame from feasibility acceptance to patient enrolment was 12.9 months (range 2.7–33.5 months.Conclusion: Improving the trial feasibility process would markedly improve a trial site’s ability to plan effectively and efficiently allocate appropriate resources.Keywords: resource allocation, business planning, clinical research organizations

  18. Cardiovascular drug trials: how to examine interaction, and why so

    NARCIS (Netherlands)

    Cleophas, T. J.; Zwinderman, A. H.; van Ouwerkerk, B.; Sobh, M.

    2007-01-01

    Background: In practice the benefit of cardiovascular medicines is less consistent than it is in clinical trials. This is due to multiple uncontrolled factors that co-determine the efficacy of the new treatment. In statistical terms, they interact with the new treatment. Interaction effects are

  19. Examining the challenges of recruiting women into a cardiac rehabilitation clinical trial.

    Science.gov (United States)

    Beckie, Theresa M; Mendonca, Mary Ann; Fletcher, Gerald F; Schocken, Douglas D; Evans, Mary E; Banks, Steven M

    2009-01-01

    To examine the challenges of recruiting women for a 5-year cardiac rehabilitation randomized clinical trial; the aims of the study were to describe the range of recruitment sources, examine the myriad of factors contributing to ineligibility and nonparticipation of women during protocol screening, and discuss the challenges of enrolling women in the trial. The Women's-Only Phase II Cardiac Rehabilitation program used an experimental design with 2 treatment groups. Eligible participants included women who were (1) diagnosed with a myocardial infarction or stable angina or had undergone coronary revascularization within the last 12 months; (2) able to read, write, and speak English; and (3) older than 21 years. Responses to multiple recruitment strategies including automatic hospital referrals, physician office referrals, mass mailings, media advertisements, and community outreach are described. Reasons for ineligibility and nonparticipation in the trial are explored. Automatic hospital order was the largest source of referral (n = 1,367, 81%) accounting for the highest enrollment rate of women (n = 184, 73%). The barriers to enrollment into the cardiac rehabilitation clinical trial included patient-oriented, provider-oriented, and programmatic factors. Of the referral sources, 52% were screened ineligible for provider-oriented reasons, 31% were ineligible due to patient-oriented factors, and 17.4% were linked to the study protocol. Study nonparticipation of those eligible (73.8%) was largely associated with patient-oriented factors (65.2%), with far less due to provider-related factors (4%) or study-related factors (3.4%). Standing hospital orders facilitated enrollment to the cardiac rehabilitation clinical trial, yet women failed to participate predominantly due to significant patient-oriented biopsychosocial barriers.

  20. Interactive spaced-education to teach the physical examination: a randomized controlled trial.

    Science.gov (United States)

    Kerfoot, B Price; Armstrong, Elizabeth G; O'Sullivan, Patricia N

    2008-07-01

    Several studies have documented that physical examination knowledge and skills are limited among medical trainees. The objective of the study is to investigate the efficacy and acceptability of a novel online educational methodology termed 'interactive spaced-education' (ISE) as a method to teach the physical examination. The design of the study is randomized controlled trial. All 170 second-year students in the physical examination course at Harvard Medical School were eligible to enroll. Spaced-education items (questions and explanations) were developed on core physical examination topics and were content-validated by two experts. Based on pilot-test data, 36 items were selected for inclusion. Students were randomized to start the 18-week program in November 2006 or 12 weeks later. Students were sent 6 spaced-education e-mails each week for 6 weeks (cycle 1) which were then repeated in two subsequent 6-week cycles (cycles 2 and 3). Students submitted answers to the questions online and received immediate feedback. An online end-of-program survey was administered. One-hundred twenty students enrolled in the trial. Cycles 1, 2, and 3 were completed by 88%, 76%, and 71% of students, respectively. Under an intent-to-treat analysis, cycle 3 scores for cohort A students [mean 74.0 (SD 13.5)] were significantly higher than cycle 1 scores for cohort B students [controls; mean 59.0 (SD 10.5); P physical examination and is very well-accepted by students.

  1. A cluster randomised controlled trial in primary dental care based intervention to improve professional performance on routine oral examinations and the management of asymptomatic impacted third molars: study protocol

    Directory of Open Access Journals (Sweden)

    Grol Richard PTM

    2007-04-01

    Full Text Available Abstract Background Routine oral examination (ROE refers to periodic monitoring of the general and oral health status of patients. In most developed Western countries a decreasing prevalence of oral diseases underpins the need for a more individualised approach in assigning individualised recall intervals for regular attendees instead of systematic fixed intervals. From a quality-of-care perspective, the effectiveness of the widespread prophylactic removal of mandibular impacted asymptomatic third molars (MIM in adolescents and adults is also questionable. Data on the effectiveness of appropriate interventions to tackle such problems, and for promoting continuing professional development in oral health care are rare. Methods/design This study is a cluster randomised controlled trial with groups of GDPs as the unit of randomisation. The aim is to determine the effectiveness and efficiency of small group quality improvement on professional decision-making of general dental practitioners (GDPs in daily practice. Six peer groups ('IQual-groups' shall be randomised either to the intervention arm I or arm II. Groups of GDPs allocated to either of these arms act as each other's control group. An IQual peer group consists of eight to ten GDPs who meet in monthly structured sessions scheduled for discussion on practice-related topics. GDPs in both trial arms receive recently developed evidence-based clinical practice guidelines (CPG on ROE or MIM. The implementation strategy consists of one interactive IQual group meeting of two to three hours. In addition, both groups of GDPs receive feedback on personal and group characteristics, and are invited to make use of web-based patient risk vignettes for further individual training on risk assessment policy. Reminders (flow charts will be sent by mail several weeks after the meeting. The main outcome measure for the ROE intervention arm is the use and appropriateness of individualised risk assessment in

  2. Study protocol for two randomized controlled trials examining the effectiveness and safety of current weekend allied health services and a new stakeholder-driven model for acute medical/surgical patients versus no weekend allied health services.

    Science.gov (United States)

    Haines, Terry P; O'Brien, Lisa; Mitchell, Deb; Bowles, Kelly-Ann; Haas, Romi; Markham, Donna; Plumb, Samantha; Chiu, Timothy; May, Kerry; Philip, Kathleen; Lescai, David; McDermott, Fiona; Sarkies, Mitchell; Ghaly, Marcelle; Shaw, Leonie; Juj, Genevieve; Skinner, Elizabeth H

    2015-04-02

    Disinvestment from inefficient or ineffective health services is a growing priority for health care systems. Provision of allied health services over the weekend is now commonplace despite a relative paucity of evidence supporting their provision. The relatively high cost of providing this service combined with the paucity of evidence supporting its provision makes this a potential candidate for disinvestment so that resources consumed can be used in other areas. This study aims to determine the effectiveness, cost-effectiveness and safety of the current model of weekend allied health service and a new stakeholder-driven model of weekend allied health service delivery on acute medical and surgical wards compared to having no weekend allied health service. Two stepped wedge, cluster randomised trials of weekend allied health services will be conducted in six acute medical/surgical wards across two public metropolitan hospitals in Melbourne (Australia). Wards have been chosen to participate by management teams at each hospital. The allied health services to be investigated will include physiotherapy, occupational therapy, speech therapy, dietetics, social work and allied health assistants. At baseline, all wards will be receiving weekend allied health services. Study 1 intervention will be the sequential disinvestment (roll-in) of the current weekend allied health service model from each participating ward in monthly intervals and study 2 will be the roll-out of a new stakeholder-driven model of weekend allied health service delivery. The order in which weekend allied health services will be rolled in and out amongst participating wards will be determined randomly. This trial will be conducted in each of the two participating hospitals at a different time interval. Primary outcomes will be length of stay, rate of unplanned hospital readmission within 28 days and rate of adverse events. Secondary outcomes will be number of complaints and compliments, staff absenteeism

  3. Examining Gender Bias in Studies of Innovation

    OpenAIRE

    Crowden, N.

    2003-01-01

    This paper examines the presence of a gender bias in studies of innovation. Using the Innovation Systems Research Network (ISRN) and its interview guide as a case study, this research project examines how accurately and completely such innovation studies present gender differences in the innovation process.

  4. Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy.

    Science.gov (United States)

    Saeki, Hiroshi; Emi, Yasunori; Oki, Eiji; Tokunaga, Shoji; Kakeji, Yoshihiro; Akagi, Yoshito; Baba, Hideo; Baba, Eishi; Maehara, Yoshihiko

    2018-01-08

    Oxaliplatin + S-1 is a recognized treatment regimen in Japan, but there are no Japanese clinical data on an oxaliplatin dose of 130 mg/m 2 . The current research involves a single-arm, prospective, phase II clinical trial to examine the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg/m 2 to treat HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy in Japan. The primary endpoint of this trial will be the response rate, and the secondary endpoints will be the safety profile of oxaliplatin + S-1, progression-free survival, the response rate in subjects under the age of 75, overall survival, time to treatment failure, duration of treatment, time to failure of strategy, and dose intensity. The threshold response rate is 45% and the expected response rate is 60%. Assuming that a one-tailed score test will be performed with an α of 0.05, 68 patients are needed to ensure a statistical power of 80%. Planned enrollment is 70 subjects and the total duration of this trial is expected to be 3 years. Since replacing cisplatin with oxaliplatin should provide the same level of therapeutic efficacy while limiting adverse events and simplifying treatment, oxaliplatin + S-1 may be increasingly used to treat gastric cancer in Japan. Verifying the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg is an important task that the current trial has set out to achieve. The protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID UMIN000017550) on May 29, 2015. The details are available at the following web address: http://www.umin.ac.jp/ctr/ .

  5. A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials.

    Science.gov (United States)

    Conroy, Elizabeth J; Arch, Barbara; Harman, Nicola L; Lane, J Athene; Lewis, Steff C; Norrie, John; Sydes, Matthew R; Gamble, Carrol

    2017-12-08

    The DAMOCLES project established a widely used Data Monitoring Committee (DMC) Charter for randomised controlled trials (RCTs). Typically, within the UK, the DMC is advisory and recommends to another executive body; the Trial Steering Committee (TSC). Despite the executive role of the TSC, the CONSORT Statement does not explicitly require reporting of TSC activity, although is included as an example of good reporting. A lack of guidance on TSC reporting can impact transparency of trial oversight, ultimately leading to a misunderstanding regarding role and, subsequently, further variation in practice. This review aimed to establish reporting practice of TSC involvement in RCTs, and thus make recommendations for reporting. A cohort examination identifying reporting practice was undertaken. The cohort comprised RCTs published in three leading medical journals (the British Medical Journal, The Lancet and the New England Journal of Medicine) within 6 months in 2012 and the full NIHR HTA Monograph series. Details of TSC constitution and impact were extracted from main publications and published supplements. Of 415 publications, 264 were eligible. These were typical in terms of trial design. Variations in reporting between journals and monographs was notable. TSC presence was identified in approximately half of trials (n = 144), of which 109 worked alongside a DMC. No publications justified not convening a TSC. When reported, the role of the committee and examples of impact in design, conduct and analysis were summarised. We present the first review of reporting TSC activity in the published academic literature. An absence of reporting standards with regards to TSC constitution, activity and impact on trial conduct was identified which can influence transparency of reporting trial oversight. Consistent reporting is vital for the benefits and impact of the TSC role to be understood to support adoption of this oversight structure and reduce global variations in

  6. Cytopathological Examination and Epidemiological Study of ...

    African Journals Online (AJOL)

    Cytopathological Examination and Epidemiological Study of Cervicitis in Commercial Sex Workers (Csws) in Coal City (Enugu), Nigeria. ... was collected from the endocervix of about one hundred and eighteen (n=118) CSWs between November, 2014 and February, 2015 using the liquid-based cytology (LBC) method.

  7. Examining Longitudinal Stimulant Use and Treatment Attendance as Parallel Outcomes in Two Contingency Management Randomized Clinical Trials.

    Science.gov (United States)

    McPherson, Sterling; Brooks, Olivia; Barbosa-Leiker, Celestina; Lederhos, Crystal; Lamp, Amanda; Murphy, Sean; Layton, Matthew; Roll, John

    2016-02-01

    The primary aim of this study was to examine stimulant use and longitudinal treatment attendance in one 'parallel outcomes' model in order to determine how these two outcomes are related to one another during treatment, and to quantify how the intervention impacts these two on- and off-target outcomes differently. Data came from two multi-site randomized clinical trials (RCTs) of contingency management (CM) that targeted stimulant use. We used parallel multilevel modeling to examine the impact of multiple pre-specified covariates, including selected Addiction Severity Index (ASI) scores, age and sex, in addition to CM on concurrent attendance and stimulant use in two separate analyses, i.e., one per trial. In one trial, CM was positively associated with attending treatment throughout the trial (β=0.060, prelationship between attendance and (-)UA submission, but in the first trial a (-)UA at both baseline and over time was related to attendance over time (r=0.117; r=0.013, respectively) and in the second trial, a (-)UA submission at baseline was associated with increased attendance over time (r=0.055). These findings indicate that stimulant use and treatment attendance over time are related but distinct outcomes that, when analyzed simultaneously, portray a more informative picture of their predictors and the separate trajectories of each. This 'indirect reinforcement' between two clinically meaningful on-target (directly reinforced behavior) and off-target (indirectly reinforced behavior) outcomes is in need of further examination in order to fully exploit the potential clinical benefits that could be realized in substance use disorder treatment trials. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Delivering Online Examinations: A Case Study

    Directory of Open Access Journals (Sweden)

    John MESSING

    2004-07-01

    Full Text Available Delivering Online Examinations: A Case Study Jason HOWARTH John MESSING Irfan ALTAS Charles Sturt University Wagga Wagga-AUSTRALIA ABSTRACT This paper represents a brief case study of delivering online examinations to a worldwide audience. These examinations are delivered in partnership with a commercial online testing company as part of the Industry Master’s degree at Charles Sturt University (CSU. The Industry Master’s degree is an academic program for students currently employed in the IT industry. Using Internet Based Testing (IBT, these students are examined in test centres throughout the world. This offers many benefits. For example, students have the freedom of sitting exams at any time during a designated interval. Computer-based testing also provides instructors with valuable feedback through test statistics and student comments. In this paper, we document CSU’s use of the IBT system, including how tests are built and delivered, and how both human and statistical feedback is used to evaluate and enhance the testing process.

  9. Randomized, Controlled Trial to Examine the Impact of Providing Yogurt to Women Enrolled in WIC

    Science.gov (United States)

    Fung, Ellen B.; Ritchie, Lorrene D.; Walker, Brent H.; Gildengorin, Ginny; Crawford, Patricia B.

    2010-01-01

    Objective: Examine the impact of providing yogurt to women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Design: Randomized, controlled intervention trial. Setting: Two California WIC local agency sites. Participants: 511 pregnant, breast-feeding, or postpartum women. Intervention: Substitution of…

  10. Destructive examination of test plates 1 and 2 of the defects detection trials

    International Nuclear Information System (INIS)

    Crutzen, S.; Buergers, W.; Violin, F.; Di Piazza, L.; Cowburn, K.; Sargent, T.

    1983-01-01

    A further phase of the UKAEA defect detection trials (described previously) with PWR pressure vessel steels is reported. The evaluation of NDT exercise results must be based on destructive examination of the plates used during the exercise. Tests are described and results given. (U.K.)

  11. Bath Breakfast Project (BBP)--examining the role of extended daily fasting in human energy balance and associated health outcomes: study protocol for a randomised controlled trial [ISRCTN31521726].

    Science.gov (United States)

    Betts, James A; Thompson, Dylan; Richardson, Judith D; Chowdhury, Enhad A; Jeans, Matthew; Holman, Geoffrey D; Tsintzas, Kostas

    2011-07-08

    Current guidance regarding the role of daily breakfast in human health is largely grounded in cross-sectional observations. However, the causal nature of these relationships has not been fully explored and what limited information is emerging from controlled laboratory-based experiments appears inconsistent with much existing data. Further progress in our understanding therefore requires a direct examination of how daily breakfast impacts human health under free-living conditions. The Bath Breakfast Project (BBP) is a randomised controlled trial comparing the effects of daily breakfast consumption relative to extended fasting on energy balance and human health. Approximately 70 men and women will undergo extensive laboratory-based assessments of their acute metabolic responses under fasted and post-prandial conditions, to include: resting metabolic rate, substrate oxidation, dietary-induced thermogenesis and systemic concentrations of key metabolites/hormones. Physiological and psychological indices of appetite will also be monitored both over the first few hours of the day (i.e. whether fed or fasted) and also following a standardised test lunch used to assess voluntary energy intake under controlled conditions. Baseline measurements of participants' anthropometric characteristics (e.g. DEXA) will be recorded prior to intervention, along with an oral glucose tolerance test and acquisition of adipose tissue samples to determine expression of key genes and estimates of tissue-specific insulin action. Participants will then be randomly assigned either to a group prescribed an energy intake of ≥3000 kJ before 1100 each day or a group to extend their overnight fast by abstaining from ingestion of energy-providing nutrients until 1200 each day, with all laboratory-based measurements followed-up 6 weeks later. Free-living assessments of energy intake (via direct weighed food diaries) and energy expenditure (via combined heart-rate/accelerometry) will be made during the

  12. A pilot study examining the effectiveness of physical therapy as an adjunct to selective nerve root block in the treatment of lumbar radicular pain from disk herniation: a randomized controlled trial.

    Science.gov (United States)

    Thackeray, Anne; Fritz, Julie M; Brennan, Gerard P; Zaman, Faisel M; Willick, Stuart E

    2010-12-01

    Therapeutic selective nerve root blocks (SNRBs) are a common intervention for patients with sciatica. Patients often are referred to physical therapy after SNRBs, although the effectiveness of this intervention sequence has not been investigated. This study was a preliminary investigation of the effectiveness of SNRBs, with or without subsequent physical therapy, in people with low back pain and sciatica. This investigation was a pilot randomized controlled clinical trial. The settings were spine specialty and physical therapy clinics. Forty-four participants (64% men; mean age=38.5 years, SD=11.6 years) with low back pain, with clinical and imaging findings consistent with lumbar disk herniation, and scheduled to receive SNRBs participated in the study. They were randomly assigned to receive either 4 weeks of physical therapy (SNRB+PT group) or no physical therapy (SNRB alone [SNRB group]) after the injections. All participants received at least 1 SNRB; 28 participants (64%) received multiple injections. Participants in the SNRB+PT group attended an average of 6.0 physical therapy sessions over an average of 23.9 days. Outcomes were assessed at baseline, 8 weeks, and 6 months with the Low Back Pain Disability Questionnaire, a numeric pain rating scale, and the Global Rating of Change. Significant reductions in pain and disability occurred over time in both groups, with no differences between groups at either follow-up for any outcome. Nine participants (5 in the SNRB group and 4 in the SNRB+PT group) underwent surgery during the follow-up period. The limitations of this study were a relatively short-term follow-up period and a small sample size. A physical therapy intervention after SNRBs did not result in additional reductions in pain and disability or perceived improvements in participants with low back pain and sciatica.

  13. A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors

    Directory of Open Access Journals (Sweden)

    Cinnamon S. Bloss

    2016-01-01

    Full Text Available Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers–some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program–making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large

  14. A randomized trial of hypothesis-driven vs screening neurologic examination.

    Science.gov (United States)

    Kamel, Hooman; Dhaliwal, G; Navi, B B; Pease, A R; Shah, M; Dhand, A; Johnston, S C; Josephson, S A

    2011-10-04

    We hypothesized that trainees would perform better using a hypothesis-driven rather than a traditional screening approach to the neurologic examination. We randomly assigned 16 medical students to perform screening examinations of all major aspects of neurologic function or hypothesis-driven examinations focused on aspects suggested by the history. Each student examined 4 patients, 2 of whom had focal deficits. Outcomes of interest were the correct identification of patients with focal deficits, number of specific deficits detected, and examination duration. Outcomes were assessed by an investigator blinded to group assignments. The McNemar test was used to compare the sensitivity and specificity of the 2 examination methods. Sensitivity was higher with hypothesis-driven examinations than with screening examinations (78% vs 56%; p = 0.046), although specificity was lower (71% vs 100%; p = 0.046). The hypothesis-driven group identified 61% of specific examination abnormalities, whereas the screening group identified 53% (p = 0.008). Median examination duration was 1 minute shorter in the hypothesis-driven group (7.0 minutes vs 8.0 minutes; p = 0.13). In this randomized trial comparing 2 methods of neurologic examination, a hypothesis-driven approach resulted in greater sensitivity and a trend toward faster examinations, at the cost of lower specificity, compared with the traditional screening approach. Our findings suggest that a hypothesis-driven approach may be superior when the history is concerning for an acute focal neurologic process.

  15. A systematic review of randomized controlled trials examining the effectiveness of saffron (Crocus sativus L.) on psychological and behavioral outcomes.

    Science.gov (United States)

    Hausenblas, Heather Ann; Heekin, Kacey; Mutchie, Heather Lee; Anton, Stephen

    2015-07-01

    Throughout the past three decades, increased scientific attention has been given to examining saffron's (Crocus sativus L.) use as a potential therapeutic or preventive agent for a number of health conditions, including cancer, cardiovascular disease, and depression. The purpose of this systematic review is to examine and categorize the current state of scientific evidence from randomized controlled trials (RCTs) regarding the efficacy of saffron on psychological/behavioral outcomes. Electronic and non-electronic systematic searches were conducted to identify all relevant human clinical research on saffron. The search strategy was extensive and was designed according to the "Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)." Reference lists of articles that met the inclusion criteria were searched. Only English language studies were reviewed. Saffron trials in combination with other substances and saffron safety studies were considered, in accordance with the PRISMA statement. Included studies must have a control group. Included studies must measure a physiological and/or a behavioral outcome. The methodological quality of all included studies was independently evaluated by two reviewers using the Jadad score. Mean scores and P-values of measures were compared both inter- and intra-study for each parameter (i.e., depression). Twelve studies met our inclusion criteria. These studies examined the effects of saffron on psychological/behavioral outcomes of: major depressive disorder (n=6), premenstrual syndrome (n = 1), sexual dysfunction and infertility (n=4), and weight loss/snacking behaviors (n=1). The data from these studies support the efficacy of saffron as compared to placebo in improving the following conditions: depressive symptoms (compared to anti-depressants and placebo), premenstrual symptoms, and sexual dysfunction. In addition, saffron use was also effective in reducing excessive snacking behavior. Findings from initial

  16. A single error is one too many: Examining alternative cutoffs on Trial 2 of the TOMM.

    Science.gov (United States)

    Erdodi, Laszlo A; Rai, Jaspreet K

    2017-01-01

    This study investigated the potential of alternative, more liberal cutoffs on Trial 2 of the Test of Memory Malingering (TOMM) to improve classification accuracy relative to the standard cutoffs (≤44). The sample consisted of 152 patients (49.3% male) with psychiatric conditions (PSY) and traumatic brain injury (TBI) referred for neuropsychological assessment in a medico-legal setting (M Age = 44.4, M Education = 11.9 years). Classification accuracy for various TOMM Trial 2 cutoffs was computed against three criterion measures. Patients with TBI failed TOMM Trial 2 cutoffs at higher rates than patients with PSY. Trial 2 ≤49 achieved acceptable combinations of sensitivity (0.38-0.67) and specificity (0.89-0.96) in all but one comparison group. Trial 2 ≤48 improved specificity (0.94-0.98) with minimal loss in sensitivity. The standard cutoff (≤44) disproportionally traded sensitivity (0.15-0.50) for specificity (0.96-1.00). One error on TOMM Trial 2 constitutes sufficient evidence to question the credibility of a response set. However, the confidence in classifying a score as invalid continues to increase with each additional error. Even at the most liberal conceivable cutoff (≤49), the TOMM detected only about half of the patients who failed other criterion measures. Therefore, it should never be used in isolation to determine performance validity.

  17. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  18. Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major

    DEFF Research Database (Denmark)

    Jakobsen, Janus Christian

    2014-01-01

    reviews. The two modern forms of psychotherapy, "third wave" cognitive therapy and mentalization-based treatment, have both gained some ground as treatments of psychiatric disorders. No randomised trial has compared the effects of these two interventions for major depressive disorder. We performed two...... (systematic error) and low risks of random errors ("play of chance") examining the effects of third wave' cognitive therapy versus mentalization-based treatment for major depressive disorder. We conducted a randomised trial according to good clinical practice examining the effects of "third wave" cognitive...... trial with low risks of bias and low risks of random errors examining the effects of "third wave" cognitive therapy versus mentalization-based therapy in a setting in the Danish healthcare system. It turned out to be much more difficult to recruit participants in the randomised trial than expected. We...

  19. Resource-oriented coaching for reduction of examination-related stress in medical students: an exploratory randomized controlled trial.

    Science.gov (United States)

    Kötter, Thomas; Niebuhr, Frank

    2016-01-01

    The years spent in acquiring medical education is considered a stressful period in the life of many students. Students whose mental health deteriorates during this long period of study are less likely to become empathic and productive physicians. In addition to other specific stressors, academic examinations seem to further induce medical school-related stress and anxiety. Combined group and individual resource-oriented coaching early in medical education might reduce examination-related stress and anxiety and, consequently, enhance academic performance. Good quality evidence, however, remains scarce. In this study, therefore, we explored the question of whether coaching affects examination-related stress and health in medical students. We conducted a randomized controlled trial. Students who registered for the first medical academic examination in August 2014 at the University of Lübeck were recruited and randomized into three groups. The intervention groups 1 and 2 received a 1-hour psychoeducative seminar. Group 1 additionally received two 1-hour sessions of individual coaching during examination preparation. Group 3 served as a control group. We compared changes in self-rated general health (measured by a single item), anxiety and depression (measured by the hospital anxiety and depression scale), as well as medical school stress (measured by the perceived medical school stress instrument). In order to further investigate the influence of group allocation on perceived medical school stress, we conducted a linear regression analysis. We saw a significant deterioration of general health and an increase in anxiety and depression scores in medical students while preparing for an examination. We found a small, but statistically significant, effect of group allocation on the development of perceived medical school stress. However, we could not differentiate between the effects of group coaching only and group coaching in combination with two sessions of individual

  20. Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

    Directory of Open Access Journals (Sweden)

    K. O. Zupanets

    2016-03-01

    Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

  1. Randomised controlled trial examining the effect of exercise in people with rheumatoid arthritis taking anti-TNFα therapy medication

    Directory of Open Access Journals (Sweden)

    Veale Douglas J

    2011-01-01

    Full Text Available Abstract Background Substantial progress has been made in the medical management of rheumatoid arthritis (RA over the past decade with the introduction of biologic therapies, including anti-tumour necrosis factor alpha (anti-TNFα therapy medications. However, individuals with RA taking anti-TNFα medication continue to experience physical, psychological and functional consequences, which could potentially benefit from rehabilitation. There is evidence that therapeutic exercise should be included as an intervention for people with RA, but to date there is little evidence of the benefits of therapeutic exercise for people with RA on anti-TNFα therapy medication. A protocol for a multicentre randomised controlled three-armed study which aims to examine the effect of dynamic group exercise therapy on land or in water for people with RA taking anti-TNFα therapy medication is described. Methods/Design Six hundred and eighteen individuals with RA, on anti-TNFα therapy medication, will be randomised into one of 3 groups: a land-based exercise group; a water-based exercise group or a control group. The land and water-based groups will exercise for one hour, twice a week for eight weeks. The control group will receive no intervention and will be asked not to alter their exercise habits for the duration of the study. The primary outcome measure, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI which measures functional ability, and secondary measures of pain, fatigue and quality of life, will be assessed at baseline, eight and 24 weeks by an independent assessor unaware of group allocation. Changes in outcome from 0 to 8 weeks and 0 to 24 weeks in the 'land-based exercise group versus control group' and the 'water-based exercise group versus control group' will be examined. Analysis will be conducted on an intention to treat basis. Discussion This trial will evaluate the effectiveness of group exercise therapy on land or in water

  2. Association Between Flexible Duty Hour Policies and General Surgery Resident Examination Performance: A Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Analysis.

    Science.gov (United States)

    Blay, Eddie; Hewitt, D Brock; Chung, Jeanette W; Biester, Thomas; Fiore, James F; Dahlke, Allison R; Quinn, Christopher M; Lewis, Frank R; Bilimoria, Karl Y

    2017-02-01

    Concerns persist about the effect of current duty hour reforms on resident educational outcomes. We investigated whether a flexible, less-restrictive duty hour policy (Flexible Policy) was associated with differential general surgery examination performance compared with current ACGME duty hour policy (Standard Policy). We obtained examination scores on the American Board of Surgery In-Training Examination, Qualifying Examination (written boards), and Certifying Examination (oral boards) for residents in 117 general surgery residency programs that participated in the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial. Using bivariate analyses and regression models, we compared resident examination performance across study arms (Flexible Policy vs Standard Policy) for 2015 and 2016, and 1 year of the Qualifying Examination and Certifying Examination. Adjusted analyses accounted for program-level factors, including the stratification variable for randomization. In 2016, FIRST trial participants were 4,363 general surgery residents. Mean American Board of Surgery In-Training Examination scores for residents were not significantly different between study groups (Flexible Policy vs Standard Policy) overall (Flexible Policy: mean [SD] 502.6 [100.9] vs Standard Policy: 502.7 [98.6]; p = 0.98) or for any individual postgraduate year level. There was no difference in pass rates between study arms for either the Qualifying Examination (Flexible Policy: 90.4% vs Standard Policy: 90.5%; p = 0.99) or Certifying Examination (Flexible Policy: 86.3% vs Standard Policy: 88.6%; p = 0.24). Results from adjusted analyses were consistent with these findings. Flexible, less-restrictive duty hour policies were not associated with differences in general surgery resident performance on examinations during the FIRST Trial. However, more years under flexible duty hour policies might be needed to observe an effect. Copyright © 2016 American College of Surgeons

  3. Randomized prospective trial comparing ultrasonography and pelvic examination for preterm labor surveillance.

    Science.gov (United States)

    Lorenz, R P; Comstock, C H; Bottoms, S F; Marx, S R

    1990-06-01

    This study was designed to compare the effectiveness of cervical assessment by either ultrasonography or bimanual pelvic examination in a program for preterm labor surveillance. Patients (n = 57) at risk for preterm birth were seen once a week for patient education, review of symptoms, and cervical evaluation. Cervical evaluation was assigned randomly to either ultrasonographic evaluation or pelvic examination. The groups did not differ in demographic or obstetric factors. The overall rate of prematurity was 18%. Preterm labor was more frequent with ultrasonographic evaluation (52%) than with pelvic examination (25%) (p less than 0.05). The group evaluated by ultrasonography received oral tocolytic agents (55%) more than the group that had pelvic examinations (21%) (p less than 0.02). The groups did not differ in infant birth weights, length of gestation, or neonatal mortality or morbidity. In this prospective randomized study of patients at risk for preterm birth, patients under surveillance by ultrasonographic assessment of the cervix did not fare better than those assigned to bimanual examination.

  4. The Use of Deception in Public Health Behavioral Intervention Trials: A Case Study of Three Online Alcohol Trials

    Science.gov (United States)

    McCambridge, Jim; Kypri, Kypros; Bendtsen, Preben; Porter, John

    2013-01-01

    Some public health behavioral intervention research studies involve deception. A methodological imperative to minimize bias can be in conflict with the ethical principle of informed consent. As a case study, we examine the specific forms of deception used in three online randomized controlled trials evaluating brief alcohol interventions. We elaborate our own decision making about the use of deception in these trials, and present our ongoing findings and uncertainties. We discuss the value of the approach of pragmatism for examining these kinds of ethical issues that can arise in research on public health interventions. PMID:24161181

  5. Effect of Access to an Electronic Medical Resource on Performance Characteristics of a Certification Examination: A Randomized Controlled Trial.

    Science.gov (United States)

    Lipner, Rebecca S; Brossman, Bradley G; Samonte, Kelli M; Durning, Steven J

    2017-09-05

    Electronic resources are increasingly used in medical practice. Their use during high-stakes certification examinations has been advocated by many experts, but whether doing so would affect the capacity to differentiate between high and low abilities is unknown. To determine the effect of electronic resources on examination performance characteristics. Randomized controlled trial. Medical certification program. 825 physicians initially certified by the American Board of Internal Medicine (ABIM) who passed the Internal Medicine Certification examination or sat for the Internal Medicine Maintenance of Certification (IM-MOC) examination in 2012 to 2015. Participants were randomly assigned to 1 of 4 conditions: closed book using typical or additional time, or open book (that is, UpToDate [Wolters Kluwer]) using typical or additional time. All participants took the same modified version of the IM-MOC examination. Primary outcomes included item difficulty (how easy or difficult the question was), item discrimination (how well the question differentiated between high and low abilities), and average question response time. Secondary outcomes included examination dimensionality (that is, the number of factors measured) and test-taking strategy. Item response theory was used to calculate question characteristics. Analysis of variance compared differences among conditions. Closed-book conditions took significantly less time than open-book conditions (mean, 79.2 seconds [95% CI, 78.5 to 79.9 seconds] vs. 110.3 seconds [CI, 109.2 to 111.4 seconds] per question). Mean discrimination was statistically significantly higher for open-book conditions (0.34 [CI, 0.32 to 0.35] vs. 0.39 [CI, 0.37 to 0.41] per question). A strong single dimension showed that the examination measured the same factor with or without the resource. Only 1 electronic resource was evaluated. Inclusion of an electronic resource with time constraints did not adversely affect test performance and did not change

  6. Resource-oriented coaching for reduction of examination-related stress in medical students: an exploratory randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kötter T

    2016-08-01

    Full Text Available Thomas Kötter,1 Frank Niebuhr2 1Institute of Social Medicine and Epidemiology, 2Institute of Family Medicine, University of Lübeck, Lübeck, Germany Introduction: The years spent in acquiring medical education is considered a stressful period in the life of many students. Students whose mental health deteriorates during this long period of study are less likely to become empathic and productive physicians. In addition to other specific stressors, academic examinations seem to further induce medical school-related stress and anxiety. Combined group and individual resource-oriented coaching early in medical education might reduce examination-related stress and anxiety and, consequently, enhance academic performance. Good quality evidence, however, remains scarce. In this study, therefore, we explored the question of whether coaching affects examination-related stress and health in medical students.Methods: We conducted a randomized controlled trial. Students who registered for the first medical academic examination in August 2014 at the University of Lübeck were recruited and randomized into three groups. The intervention groups 1 and 2 received a 1-hour psychoeducative seminar. Group 1 additionally received two 1-hour sessions of individual coaching during examination preparation. Group 3 served as a control group. We compared changes in self-rated general health (measured by a single item, anxiety and depression (measured by the hospital anxiety and depression scale, as well as medical school stress (measured by the perceived medical school stress instrument. In order to further investigate the influence of group allocation on perceived medical school stress, we conducted a linear regression analysis.Results: We saw a significant deterioration of general health and an increase in anxiety and depression scores in medical students while preparing for an examination. We found a small, but statistically significant, effect of group allocation on

  7. Physical examination skills training: Faculty staff vs. patient instructor feedback-A controlled trial.

    Directory of Open Access Journals (Sweden)

    Markus Krautter

    Full Text Available Standardized patients are widely used in training of medical students, both in teaching and assessment. They also frequently lead complete training sessions delivering physical examination skills without the aid of faculty teaching staff-acting as "patient instructors" (PIs. An important part of this training is their ability to provide detailed structured feedback to students which has a strong impact on their learning success. Yet, to date no study has assessed the quality of physical examination related feedback by PIs. Therefore, we conducted a randomized controlled study comparing feedback of PIs and faculty staff following a physical examination assessed by students and video assessors.14 PIs and 14 different faculty staff physicians both delivered feedback to 40 medical students that had performed a physical examination on the respective PI while the physicians observed the performance. The physical examination was rated by two independent video assessors to provide an objective performance standard (gold standard. Feedback of PI and physicians was content analyzed by two different independent video assessors based on a provided checklist and compared to the performance standard. Feedback of PIs and physicians was also rated by medical students and video assessors using a questionnaire consisting of 12 items.There was no statistical significant difference concerning overall matching of physician or PI feedback with gold standard ratings by video assessment (p = .219. There was also no statistical difference when focusing only on items that were classified as major key steps (p = .802, mistakes or parts that were left out during physical examination (p = .219 or mistakes in communication items (p = .517. The feedback of physicians was significantly better rated than PI feedback both by students (p = .043 as well as by video assessors (p = .034.In summary, our study demonstrates that trained PIs are able to provide feedback of equal

  8. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full

  9. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement

    Directory of Open Access Journals (Sweden)

    Mona Have

    2016-04-01

    Full Text Available Abstract Background Integration of physical activity (PA into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. Methods The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools’ math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF questionnaire filled out by the parents, creativity (using the Torrance Tests of Creative Thinking, TTCT, aerobic fitness (by the Andersen intermittent shuttle-run test and body mass index. PA during math lessons and total PA (including time spent outside school were assessed using accelerometry. Math teachers used Short Message Service (SMS-tracking to report on compliance with the PA intervention and on their motivation for implementing PA in math lessons. Parents used SMS-tracking to register their children’s PA behavior in leisure time. Discussion The results of this randomized controlled trial are expected to provide schools and policy-makers with

  10. Study on Accuracy of Judgments by Chinese Fingerprint Examiners

    Directory of Open Access Journals (Sweden)

    Shiquan Liu

    2015-01-01

    Full Text Available The interpretation of fingerprint evidence depends on the judgments of fingerprint examiners. This study assessed the accuracy of different judgments made by fingerprint examiners following the Analysis, Comparison, and Evaluation (ACE process. Each examiner was given five marks for analysis, comparison, and evaluation. We compared the experts′ judgments against the ground truth and used an annotation platform to evaluate how Chinese fingerprint examiners document their comparisons during the identification process. The results showed that different examiners demonstrated different accuracy of judgments and different mechanisms to reach them.

  11. Are multiple-trial experiments appropriate for eyewitness identification studies? Accuracy, choosing, and confidence across trials.

    Science.gov (United States)

    Mansour, J K; Beaudry, J L; Lindsay, R C L

    2017-12-01

    Eyewitness identification experiments typically involve a single trial: A participant views an event and subsequently makes a lineup decision. As compared to this single-trial paradigm, multiple-trial designs are more efficient, but significantly reduce ecological validity and may affect the strategies that participants use to make lineup decisions. We examined the effects of a number of forensically relevant variables (i.e., memory strength, type of disguise, degree of disguise, and lineup type) on eyewitness accuracy, choosing, and confidence across 12 target-present and 12 target-absent lineup trials (N = 349; 8,376 lineup decisions). The rates of correct rejections and choosing (across both target-present and target-absent lineups) did not vary across the 24 trials, as reflected by main effects or interactions with trial number. Trial number had a significant but trivial quadratic effect on correct identifications (OR = 0.99) and interacted significantly, but again trivially, with disguise type (OR = 1.00). Trial number did not significantly influence participants' confidence in correct identifications, confidence in correct rejections, or confidence in target-absent selections. Thus, multiple-trial designs appear to have minimal effects on eyewitness accuracy, choosing, and confidence. Researchers should thus consider using multiple-trial designs for conducting eyewitness identification experiments.

  12. Examining Contextual Influences on Classroom-Based Implementation of Positive Behavior Support Strategies: Findings from a Randomized Controlled Effectiveness Trial.

    Science.gov (United States)

    Pas, Elise T; Waasdorp, Tracy E; Bradshaw, Catherine P

    2015-11-01

    Although it is widely recognized that variation in implementation fidelity influences the impact of preventive interventions, little is known about how specific contextual factors may affect the implementation of social and behavioral interventions in classrooms. Theoretical research highlights the importance of multiple contextual influences on implementation, including factors at the classroom and school level (Domitrovich et al., Advances in School Mental Health Promotion, 1, 6-28, 2008). The current study used multi-level modeling to empirically examine the influence of teacher, classroom, and school characteristics on the implementation of classroom-based positive behavior support strategies over the course of 4 years. Data were collected in the context of a 37-school randomized controlled trial examining the effectiveness of school-wide Positive Behavioral Interventions and Supports. Multi-level results identified several school-level contextual factors (e.g., school size, behavioral disruptions) and teacher-level factors (perceptions of school organizational health and grade level taught) associated with variability in the implementation of classroom-based positive behavior supports. Implications for prevention research and practice are discussed.

  13. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Scherer, Roberta W; Drye, Lea; Mintzer, Jacobo; Lanctôt, Krista; Rosenberg, Paul; Herrmann, Nathan; Padala, Prasad; Brawman-Mintzer, Olga; Burke, William; Craft, Suzanne; Lerner, Alan J; Levey, Allan; Porsteinsson, Anton; van Dyck, Christopher H

    2018-01-18

    Alzheimer's disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events. However, the trial only enrolled 60 participants who were followed for only 6 weeks. A larger, longer-lasting trial is required to confirm these promising findings. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a phase III, placebo-controlled, masked, 6-month, multi-center, randomized clinical trial targeted to enroll 200 participants with AD and apathy. Participants are randomly assigned 1:1 to 20 mg methylphenidate per day prepared as four over-encapsulated tablets or to matching placebo. The primary outcomes include (1) the mean difference in the Neuropsychiatric Inventory Apathy subscale scores measured as change from baseline to 6 months, and (2) the odds of having a given rating or better on the modified AD Cooperative Study Clinical Global Impression of Change ratings at month 6 compared with the baseline rating. Other outcomes include change in cognition, safety, and cost-effectiveness measured at monthly follow-up visits up to 6 months. Given the prevalence of apathy in AD and its impact on both patients and caregivers, an intervention to alleviate apathy would be of great benefit to society. ADMET 2 follows on the promising results from the original ADMET to evaluate the efficacy of methylphenidate as a

  14. A double-blind randomized controlled pilot trial examining the safety and efficacy of therapeutic touch in premature infants.

    Science.gov (United States)

    Whitley, Julie Anne; Rich, Bonnie L

    2008-12-01

    To explore the hypothesis that nontouch therapy such as therapeutic touch (TT) reduces stress to a clinically important degree and is safe to use in preterm infants. A pilot randomized, double-blind, controlled trial. Two groups of 10 infants were enrolled and randomly assigned to treatment or nontreatment groups. Gestational age was less than 29 weeks. Demographic descriptions of the 2 groups were statistically similar. The observer and staff were blinded to assignment; the TT practitioner was blinded to observed measurements. Each infant received either TT or no therapeutic touch (NTT) for 5 minutes on 3 consecutive days at the same time of day, behind a curtain. Heart period variability (HPV) was measured 5 minutes before, during, and after the treatment phase. Examination of the parameters of oxygen saturation and episodes of apnea demonstrated no increase in adverse events in TT group compared with NTT group. Repeated-measures multivariate analysis of variance on HPV revealed differences in the interaction of group assignment with low-frequency, high-frequency, and low-to-high- frequency ratio interaction (F2,143 = 8.076, P = .000) and for group, day, and low-frequency, high-frequency, and low-to-high-frequency ratio (F2,288 = 3.146, P = .015), and in the posttreatment time period (F1,16 = 6.259, P = .024), reflective of greater parasympathetic activity in TT group. In this pilot trial, HPV showed an increase for the TT group compared with the NTT group. The study reveals no adverse effects of TT in preterm infants.

  15. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    Science.gov (United States)

    2013-01-01

    Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. Methods/Design The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. Discussion The results of the trial will be used to produce a maximally

  16. A randomized controlled trial comparing instructions regarding unsafe response options in a MCQ examination.

    Science.gov (United States)

    Tweed, Mike; Wilkinson, Tim

    2009-01-01

    Marking of multiple choice type examinations often just takes account of the correct responses. This may encourage guessing of incorrect and potentially unsafe responses. Ideally responses should contain a high proportion of correct, unsafe and the use of 'don't know' response rather than incorrect. This study explored the effect of instructions on responses. Fourth- and fifth-year students sitting for an optional multiple choice examination were randomized to receive one of four instruction options: number-correct marking (the control group); alert to unsafe; mark deduction for unsafe; or correction for guessing. A total of 210 students sat the test. For the fourth-year cohort, compared with the control group, being alerted to unsafe and mark deduction for unsafe or incorrect responses were associated with graduated increases in the use of 'don't know' and reductions in incorrect responses. For the fifth-year cohort, there were no differences in responses between options. The fifth-year cohort, gave more correct, and fewer incorrect, unsafe and 'don't know' responses. Both the year group and instructions had an effect. Being alerted to potentially unsafe responses, even when there is no mark deduction penalty, had an effect, although mark deduction still had the greatest effect. Assessment instructions may give subliminal messages that have important consequences.

  17. Hypofractionated regional nodal irradiation for breast cancer: examining the data and potential for future studies.

    Science.gov (United States)

    Badiyan, Shahed N; Shah, Chirag; Arthur, Douglas; Khan, Atif J; Freedman, Gary; Poppe, Matthew M; Vicini, Frank A

    2014-01-01

    Limited data are available examining the role of hypofractionated radiation schedules in the management of women requiring regional nodal irradiation (RNI). The purpose of this review is to examine the available literature for the efficacy (where available) and toxicity of hypofractionated radiation schedules in breast cancer with RNI limited to the axilla and supraclavicular regions. Multiple randomized and prospective studies have documented the safety and efficacy of hypofractionated schedules delivering whole breast irradiation (WBI) alone. Subsets from these randomized trials and smaller prospective/single-institution studies have documented the feasibility of hypofractionated RNI but the limited numbers prevent definitive conclusions and limited efficacy data are available. With regard to possible toxicity affecting organs at risk with RNI, key structures include the breast, skin, heart, lungs, axilla (lymphedema), and brachial plexus. Based on data from several randomized trials, hypofractionated radiation is not associated with significant changes in breast toxicity/cosmesis or cardiac toxicity; the addition of hypofractionated RNI would not be expected to change the rates of breast or cardiac toxicity. While RNI has been shown to increase rates of pulmonary toxicity, hypofractionated RNI has not been associated with more frequent pulmonary complications than standard RNI. Moving forward, future studies will have to evaluate for increased lung toxicity. With regard to lymphedema, data from randomized hypofractionated WBI trials failed to demonstrate an increase in lymphedema and smaller studies utilizing hypofractionated RNI have failed to as well. Data from head and neck cancer as well as hypofractionated breast radiation with RNI have failed to demonstrate an increase in brachial plexopathy with the exception of older trials that used much larger dose per fraction (>4 Gy/fraction) schedules. At this time, published data support the feasibility of

  18. Examining self-guided internet-delivered cognitive behavior therapy for older adults with symptoms of anxiety and depression: Two feasibility open trials

    Directory of Open Access Journals (Sweden)

    Blake F. Dear

    2015-03-01

    Full Text Available Self-guided internet-delivered cognitive behavior therapy (iCBT has considerable public health potential for treating anxiety and depression. However, no research has examined the use of self-guided iCBT, that is, treatment without contact with a clinician, specifically for older adults. The aim of the present study was to undertake a preliminary examination of the acceptability, efficacy and health economic impact of two entirely self-guided iCBT programs for adults over 60 years of age with anxiety and depression. Two separate single-group feasibility open trials of self-guided iCBT were conducted, the Anxiety Trial (n = 27 and the Depression Trial (n = 20, using the control groups of two randomized controlled trials. The online treatment packages consisted of five online educational lessons, which were delivered over 8 weeks without clinical contact. Participants rated the interventions as acceptable with more than 90% reporting the course was worth their time and more than 70% of participants completing at least 3 of the 5 lessons within the eight weeks. Significant reductions on measures of anxiety (Generalized Anxiety Disorder 7-item; GAD-7 and depression (Patient Health Questionnaire 9-item; PHQ-9 were observed from pre-treatment to post-treatment in both the Anxiety Trial (GAD-7 Cohen's d = 1.17; 95% CI: 0.55 to 1.75 and the Depression Trial (PHQ-9 Cohen's d = 1.06; 95% CI: 0.33 to 1.73. The economic analyses indicated that there was statistically significant improvement in health-related quality of life compared to baseline and marginally higher costs associated with treatment for both the Anxiety Trial ($69.84; 95% CI: $4.24 to $135.45 and the Depression Trial ($54.98; 95% CI: $3.84 to $106.12. The results provide preliminary support for the potential of entirely self-guided iCBT for older adults with anxiety and depression and indicate larger scale and controlled research trials are warranted.

  19. Patient education for colon cancer screening: a randomized trial of a video mailed before a physical examination.

    Science.gov (United States)

    Zapka, Jane G; Lemon, Stephenie C; Puleo, Elaine; Estabrook, Barbara; Luckmann, Roger; Erban, Stephen

    2004-11-02

    Colorectal cancer screening is underused, and primary care clinicians are challenged to provide patient education within the constraints of busy practices. To test the effect of an educational video, mailed to patients' homes before a physical examination, on performance of colorectal cancer screening, particularly sigmoidoscopy. Randomized, controlled trial. 5 primary care practices in central Massachusetts. 938 patients age 50 to 74 years who were scheduled for an upcoming physical examination, had no personal history of colorectal cancer, and were eligible for lower-endoscopy screening according to current guidelines. Participants were randomly assigned to receive usual care (n = 488) or a video about colorectal cancer, the importance of early detection, and screening options (n = 450). Baseline and 6-month follow-up telephone assessments were conducted. A dependent variable classified screening since baseline as 1) sigmoidoscopy with or without other tests, 2) another test or test combination, or 3) no tests. Overall screening rates were the same in the intervention and control groups (55%). In regression modeling, intervention participants were nonsignificantly more likely to complete sigmoidoscopy alone or in combination with another test (odds ratio, 1.22 [95% CI, 0.88 to 1.70]). Intervention dose (viewing at least half of the video) was significantly related to receiving sigmoidoscopy with or without another test (odds ratio, 2.81 [CI, 1.85 to 4.26]). Recruitment records showed that at least 23% of people coming for periodic health assessments were currently screened by a lower-endoscopy procedure and therefore were not eligible. The primary care sample studied consisted primarily of middle-class white persons who had high screening rates at baseline. The results may not be generalizable to other populations. The trial was conducted during a period of increased health insurance coverage for lower-endoscopy procedures and public media attention to colon

  20. Examining student identity in a study abroad setting

    OpenAIRE

    Haywood, Richard

    2017-01-01

    This study examined student identity in a study abroad setting by focusing on the adjustment issues study abroad students faced in their various transitions. The aim of this research was to discover more about the role that identity plays in studying abroad through the focus on student experience and student perception of the adjustment issues faced in study abroad transitions. The research utilised qualitative methods, was longitudinal, and focused on study abroad students who undertook ELIC...

  1. Trauma memories on trial: is cross-examination a safeguard against distorted analogue traumatic memories?

    Science.gov (United States)

    Segovia, Daisy A; Strange, Deryn; Takarangi, Melanie K T

    2017-01-01

    Trauma memories can feel more disorganised than more mundane memories. That may be problematic in legal contexts. Here we examined: (a) whether that disorganised feeling makes people more susceptible to suggestive questioning during direct examination; and (b) whether cross-examination is the safeguard it is purported to be: that is, we examined whether cross-examination can uncover and correct distorted trauma memories. We showed participants a film depicting a graphic car accident. For some participants, the film unfolded in a temporally disorganised way. We then interviewed participants immediately after the film regarding what they had seen: this 'direct examination' included free recall, cued recall and yes/no questions, some of which were misleading. Then, 48 hours later, a second interviewer cross-examined participants. Contrary to our predictions, neither manipulation of the film's temporal organisation, nor participants' self-reported feelings of event disorganisation significantly affected their accuracy of the film during direct or cross-examination nor their recognition memory of the film. Instead, we found that regardless of whether participants' memories were distorted by the direct examination, the suggestive nature of the cross-examination introduced sufficient doubt that participants were willing to change their answers. We conclude that traumatic memories are vulnerable to suggestive questioning and, unfortunately, cross-examination is not the legal system's fail-safe corrective influence.

  2. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement.

    Science.gov (United States)

    Have, Mona; Nielsen, Jacob Have; Gejl, Anne Kær; Thomsen Ernst, Martin; Fredens, Kjeld; Støckel, Jan Toftegaard; Wedderkopp, Niels; Domazet, Sidsel Louise; Gudex, Claire; Grøntved, Anders; Kristensen, Peter Lund

    2016-04-11

    Integration of physical activity (PA) into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools' math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF) questionnaire filled out by the parents), creativity (using the Torrance Tests of Creative Thinking, TTCT), aerobic fitness (by the Andersen intermittent shuttle-run test) and body mass index. PA during math lessons and total PA (including time spent outside school) were assessed using accelerometry. Math teachers used Short Message Service (SMS)-tracking to report on compliance with the PA intervention and on their motivation for implementing PA in math lessons. Parents used SMS-tracking to register their children's PA behavior in leisure time. The results of this randomized controlled trial are expected to provide schools and policy-makers with significant new insights into the potential of classroom

  3. Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials.

    Science.gov (United States)

    Eggly, Susan; Hamel, Lauren M; Heath, Elisabeth; Manning, Mark A; Albrecht, Terrance L; Barton, Ellen; Wojda, Mark; Foster, Tanina; Carducci, Michael; Lansey, Dina; Wang, Ting; Abdallah, Rehab; Abrahamian, Narineh; Kim, Seongho; Senft, Nicole; Penner, Louis A

    2017-12-02

    Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial. Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the

  4. Interval lung cancer after a negative CT screening examination: CT findings and outcomes in National Lung Screening Trial participants

    Energy Technology Data Exchange (ETDEWEB)

    Gierada, David S. [Washington University School of Medicine, Mallinckrodt Institute of Radiology, Box 8131, St. Louis, MO (United States); Pinsky, Paul F. [National Cancer Institute, Bethesda, MD (United States); Duan, Fenghai [Brown University School of Public Health, Department of Biostatistics and Center for Statistical Sciences, Providence, RI (United States); Garg, Kavita [University of Colorado School of Medicine, Mail Stop F726, Box 6510, Aurora, CO (United States); Hart, Eric M. [Northwestern University, Feinberg School of Medicine, Department of Radiology, Chicago, IL (United States); Kazerooni, Ella A. [University of Michigan Health System, Department of Radiology, Ann Arbor, MI (United States); Nath, Hrudaya; Watts, Jubal R. [University of Alabama at Birmingham School of Medicine, Department of Radiology-JTN370, Birmingham, AL (United States); Aberle, Denise R. [David Geffen School of Medicine at UCLA, Department of Radiological Sciences, Los Angeles, CA (United States)

    2017-08-15

    This study retrospectively analyses the screening CT examinations and outcomes of the National Lung Screening Trial (NLST) participants who had interval lung cancer diagnosed within 1 year after a negative CT screen and before the next annual screen. The screening CTs of all 44 participants diagnosed with interval lung cancer (cases) were matched with negative CT screens of participants who did not develop lung cancer (controls). A majority consensus process was used to classify each CT screen as positive or negative according to the NLST criteria and to estimate the likelihood that any abnormalities detected retrospectively were due to lung cancer. By retrospective review, 40/44 cases (91%) and 17/44 controls (39%) met the NLST criteria for a positive screen (P < 0.001). Cases had higher estimated likelihood of lung cancer (P < 0.001). Abnormalities included pulmonary nodules ≥4 mm (n = 16), mediastinal (n = 8) and hilar (n = 6) masses, and bronchial lesions (n = 6). Cancers were stage III or IV at diagnosis in 32/44 cases (73%); 37/44 patients (84%) died of lung cancer, compared to 225/649 (35%) for all screen-detected cancers (P < 0.0001). Most cases met the NLST criteria for a positive screen. Awareness of missed abnormalities and interpretation errors may aid lung cancer identification in CT screening. (orig.)

  5. A Randomized Controlled Trial Examining the Effect of Mindfulness Meditation on Working Memory Capacity in Adolescents.

    Science.gov (United States)

    Quach, Dianna; Jastrowski Mano, Kristen E; Alexander, Kristi

    2016-05-01

    To investigate the effectiveness of a mindfulness meditation intervention on working memory capacity (WMC) in adolescents via a randomized controlled trial comparing mindfulness meditation to hatha yoga and a waitlist control group. Participants (N = 198 adolescents) were recruited from a large public middle school in southwest United States and randomly assigned to mindfulness meditation, hatha yoga, or a waitlist control condition. Participants completed a computerized measure of WMC (Automated Operational Span Task) and self-report measures of perceived stress (Perceived Stress Scale) and anxiety (Screen for Childhood Anxiety Related Emotional Disorders) at preintervention and postintervention/waitlist. A series of mixed-design analyses of variance were used to examine changes in WMC, stress, and anxiety at preintervention and postintervention. Participants in the mindfulness meditation condition showed significant improvements in WMC, whereas those in the hatha yoga and waitlist control groups did not. No statistically significant between-group differences were found for stress or anxiety. This is the first study to provide support for the benefits of short-term mindfulness practice, specifically mindfulness meditation, in improving WMC in adolescents. Results highlight the importance of investigating the components of mindfulness-based interventions among adolescents given that such interventions may improve cognitive function. More broadly, mindfulness interventions may be delivered in an abridged format, thus increasing their potential for integration into school settings and into existing treatment protocols. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  6. Intensive Language Action Therapy in Chronic Aphasia: A Randomized Clinical Trial Examining Guidance by Constraint

    Science.gov (United States)

    Stanek,, Edward J.; Stokes, Polly; Li, Minming; Andrianopoulos, Mary

    2016-01-01

    Purpose Intensive language action therapy (ILAT) can be effective in overcoming learned nonuse in chronic aphasia. It is suggested that all three guiding principles (constraint, communication embedding, massed practice) are essential to ILAT's success. We examined whether one of these, guidance by constraint, is critical. Method Twenty-four participants with aphasia (PWAs) were assigned to ILAT or a modified version of promoting aphasic communicative effectiveness (PACE) in a randomized block, single-blind, parallel-group treatment study. Blocking was by severity (mild/moderate, moderate to severe, severe). Both groups received intensive treatment in the context of therapeutic language action games. Whereas the ILAT group was guided toward spoken responses, the PACE group could choose any response modality. Results All participants, whether assigned to ILAT or PACE groups, improved on the primary outcome measure, picture naming. There was a Severity × Treatment interaction, with the largest effects estimated for PWAs with mild/moderate and moderate to severe aphasia. Regardless of severity, the ILAT group outperformed the PACE group on untrained pictures, suggesting some benefit of ILAT to generalization. However, this difference was not statistically significant. Conclusion Although the groups differed in subtle ways, including better generalization to untrained pictures for ILAT, the study was inconclusive on the influence of guidance by constraint. PMID:27997954

  7. Intensive Language Action Therapy in Chronic Aphasia: A Randomized Clinical Trial Examining Guidance by Constraint.

    Science.gov (United States)

    Kurland, Jacquie; Stanek, Edward J; Stokes, Polly; Li, Minming; Andrianopoulos, Mary

    2016-12-01

    Intensive language action therapy (ILAT) can be effective in overcoming learned nonuse in chronic aphasia. It is suggested that all three guiding principles (constraint, communication embedding, massed practice) are essential to ILAT's success. We examined whether one of these, guidance by constraint, is critical. Twenty-four participants with aphasia (PWAs) were assigned to ILAT or a modified version of promoting aphasic communicative effectiveness (PACE) in a randomized block, single-blind, parallel-group treatment study. Blocking was by severity (mild/moderate, moderate to severe, severe). Both groups received intensive treatment in the context of therapeutic language action games. Whereas the ILAT group was guided toward spoken responses, the PACE group could choose any response modality. All participants, whether assigned to ILAT or PACE groups, improved on the primary outcome measure, picture naming. There was a Severity × Treatment interaction, with the largest effects estimated for PWAs with mild/moderate and moderate to severe aphasia. Regardless of severity, the ILAT group outperformed the PACE group on untrained pictures, suggesting some benefit of ILAT to generalization. However, this difference was not statistically significant. Although the groups differed in subtle ways, including better generalization to untrained pictures for ILAT, the study was inconclusive on the influence of guidance by constraint.

  8. Anxiety sensitivity risk reduction in smokers: A randomized control trial examining effects on panic.

    Science.gov (United States)

    Schmidt, Norman B; Raines, Amanda M; Allan, Nicholas P; Zvolensky, Michael J

    2016-02-01

    Empirical evidence has identified several risk factors for panic psychopathology, including smoking and anxiety sensitivity (AS; the fear of anxiety-related sensations). Smokers with elevated AS are therefore a particularly vulnerable population for panic. Yet, there is little knowledge about how to reduce risk of panic among high AS smokers. The present study prospectively evaluated panic outcomes within the context of a controlled randomized risk reduction program for smokers. Participants (N = 526) included current smokers who all received a state-of-the-art smoking cessation intervention with approximately half randomized to the AS reduction intervention termed Panic-smoking Program (PSP). The primary hypotheses focus on examining the effects of a PSP on panic symptoms in the context of this vulnerable population. Consistent with prediction, there was a significant effect of treatment condition on AS, such that individuals in the PSP condition, compared to those in the control condition, demonstrated greater decreases in AS throughout treatment and the follow-up period. In addition, PSP treatment resulted in lower rates of panic-related symptomatology. Moreover, mediation analyses indicated that reductions in AS resulted in lower panic symptoms. The present study provides the first empirical evidence that brief, targeted psychoeducational interventions can mitigate panic risk among smokers. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. A Randomized Trial Examining the Effects of Conjoint Behavioral Consultation and the Mediating Role of the Parent-Teacher Relationship

    Science.gov (United States)

    Sheridan, Susan M.; Bovaird, James A.; Glover, Todd A.; Garbacz, S. Andrew; Witte, Amanda; Kwon, Kyongboon

    2012-01-01

    The present study is a large-scale randomized trial testing the efficacy of a family-school partnership model (i.e., conjoint behavioral consultation) for promoting behavioral competence and decreasing problem behaviors of students identified by their teachers as disruptive. The focus of this study is on student behavioral outcomes and the…

  10. A Randomized Trial Examining Housing First in Congregate and Scattered Site Formats.

    Directory of Open Access Journals (Sweden)

    Julian M Somers

    Full Text Available No previous experimental trials have investigated Housing First (HF in both scattered site (SHF and congregate (CHF formats. We hypothesized that CHF and SHF would be associated with a greater percentage of time stably housed as well as superior health and psychosocial outcomes over 24 months compared to treatment as usual (TAU.Inclusion criteria were homelessness, mental illness, and high need for support. Participants were randomised to SHF, CHF, or TAU. SHF consisted of market rental apartments with support provided by Assertive Community Treatment (ACT. CHF consisted of a single building with supports equivalent to ACT. TAU included existing services and supports.Of 800 people screened, 297 were randomly assigned to CHF (107, SHF (90, or TAU (100. The percentage of time in stable housing over 24 months was 26.3% in TAU (reference; 95% confidence interval (CI = 20.5, 32.0, compared to 74.3% in CHF (95% CI = 69.3, 79.3, p<0.001 and 74.5% in SHF (95% CI = 69.2, 79.7, p<0.001. Secondary outcomes favoured CHF but not SHF compared to TAU.HF in scattered and congregate formats is capable of achieving housing stability among people experiencing major mental illness and chronic homelessness. Only CHF was associated with improvement on select secondary outcomes.Current Controlled Trials: ISRCTN57595077.

  11. Examining uptake of online education on obstructive sleep apnoea in general practitioners: a randomised trial.

    Science.gov (United States)

    Paul, Christine; Rose, Shiho; Hensley, Michael; Pretto, Jeffrey; Hardy, Margaret; Henskens, Frans; Clinton-McHarg, Tara; Carey, Mariko

    2016-07-19

    Obstructive sleep apnoea (OSA) affects up to 28 % of the adult population in Western countries. The detection and management of OSA by general practitioners (GPs) can be poor. The study aimed to examine what influence enhanced invitations had on uptake of on-line learning modules for OSA by GPs, and whether recent referrals of patients to sleep specialists influenced uptake. Practicing GPs in regional Australia were identified and randomised to receive either an enhanced or standard invitation letter to a new on-line education module for OSA. The enhanced letter included indication that the module was eligible for professional accreditation and described the prevalence and burden of sleep disorders. Some included extra emphasis if the GP had recently referred a patient for diagnostic investigation of OSA. Two reminder letters were sent. Of 796 eligible GPs who received the letters, sixteen (2 %) accessed the website and four completed the modules over the four-month study period. GPs who received an enhanced invitation letter were not significantly more likely to access the website compared to GPs who received the standard invitation letter. Recent referral of a patient for diagnostic investigation was also not a significant factor in influencing use of the module. GP interest in on-line education about OSA appears low, and emphasis of relevant recent past patient(s) and the opportunity for professional education points was not successful in increasing engagement. There is a need to identify effective approaches to improving the detection and management of OSA in general practice.

  12. A randomised controlled trial of blended learning to improve the newborn examination skills of medical students.

    Science.gov (United States)

    Stewart, Alice; Inglis, Garry; Jardine, Luke; Koorts, Pieter; Davies, Mark William

    2013-03-01

    To evaluate the hypotheses that a blended learning approach would improve the newborn examination skills of medical students and yield a higher level of satisfaction with learning newborn examination. Undergraduate medical students at a tertiary teaching hospital were individually randomised to receive either a standard neonatology teaching programme (control group), or additional online access to the PENSKE Baby Check Learning Module (blended learning group). The primary outcome was performance of newborn examination on standardised assessment by blinded investigators. The secondary outcomes were performance of all 'essential' items of the examination, and participant satisfaction. The recruitment rate was 88% (71/81). The blended learning group achieved a significantly higher mean score than the control group (p=0.02) for newborn examination. There was no difference for performance of essential items, or satisfaction with learning newborn examination. The blended learning group rated the module highly for effective use of learning time and ability to meet specific learning needs. A blended learning approach resulted in a higher level of performance of newborn examination on standardised assessment. This is consistent with published literature on blended learning and has implications for all neonatal clinicians including junior doctors, midwifes and nurse practitioners.

  13. The study on quality control of bedside CR examination

    International Nuclear Information System (INIS)

    Yang Xufeng; Luo Xiaomei; Xu Qiaolan; Wu Tengfang; Wen Xingwei

    2007-01-01

    Objective: To study the quality controll of bedside CR examination and improves the imaging quality. Methods: X-ray examination with CR system were performed on 3,300 patients. All CR cassettes were encoded. The imaging plate and cassettes were cleaned regularly. Results: With and without quality control, the percentage of first-rate film was 58.2% and 51%, the second-rate film was 40% and 45.5%, the third-rate film was 1.3% and 2%, respectively. Corxespondingly, the ratio of re-examination decreased from 1.5% to 0.5% after quality control, and imaging quality was stable. Conclusion: The quality control of bedside CR examination can improve the image quality as well as lighten the labor of radiographers. (authors)

  14. Randomized trial to examine procedure-to-procedure transfer in laparoscopic simulator training

    DEFF Research Database (Denmark)

    Bjerrum, F; Sorensen, J L; Konge, L

    2016-01-01

    -centre educational superiority trial. Surgical novices practised basic skills on a laparoscopic virtual reality simulator. On reaching proficiency, participants were randomized to proficiency-based training. The intervention group practised two procedures on the simulator (appendicectomy followed by salpingectomy......BACKGROUND: Laparoscopic simulation has become a standard component of surgical training, but there is limited knowledge regarding skills transfer between procedural tasks. The objective was to investigate the specificity of procedural simulator training. METHODS: This was randomized single......), whereas the control group trained on only one procedure (salpingectomy). The main outcomes were number of repetitions and time to proficiency for the second procedure. RESULTS: Ninety-six participants were randomized, of whom 74 per cent were women, with a median age of 26 years. The intervention group...

  15. Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Tilbrook, Helen; Forsythe, Rachael O; Rolfe, Debbie; Clark, Laura; Bland, Martin; Buckley, Hannah; Chetter, Ian; Cook, Liz; Dumville, Jo; Gabe, Rhian; Harding, Keith; Layton, Alison; Lindsay, Ellie; McDaid, Catriona; Moffatt, Christine; Phillips, Ceri; Stansby, Gerard; Vowden, Peter; Williams, Laurie; Torgerson, David; Hinchliffe, Robert J

    2015-11-10

    Venous leg ulcers (VLUs) are the commonest cause of leg ulceration, affecting 1 in 100 adults. There is a significant health burden associated with VLUs - it is estimated that the cost of treatment for 1 ulcer is up to £1300 per year in the NHS. The mainstay of treatment is with graduated compression bandaging; however, treatment is often prolonged and up to one quarter of venous leg ulcers do not heal despite standard care. Two previous trials have suggested that low-dose aspirin, as an adjunct to standard care, may hasten healing, but these trials were small and of poor quality. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established. AVURT is a phase II randomised double blind, parallel-group, placebo-controlled efficacy trial. The primary objective is to examine whether aspirin, in addition to standard care, is effective in patients with chronic VLUs (i.e. over 6 weeks in duration or a history of VLU). Secondary objectives include feasibility and safety of aspirin in this population. A target of 100 participants, identified from community leg ulcer clinics and hospital clinics, will be randomised to receive either 300 mg of aspirin once daily or placebo. All participants will receive standard care with compression therapy. The primary outcome will be time to healing of the reference ulcer. Follow-up will occur for a maximum of 27 weeks. The primary analysis will use a Cox proportional hazards model to compare time to healing using the principles of intention-to-treat. Secondary outcomes will include ulcer size, pain evaluation, compliance and adverse events. The AVURT trial will investigate the efficacy and safety of aspirin as a treatment for VLU and will inform on the feasibility of proceeding to a larger phase III study. This study will address the paucity of information currently available regarding aspirin therapy to treat VLU. The study is registered on a public database with

  16. Physical activity after commitment lotteries: examining long-term results in a cluster randomized trial.

    Science.gov (United States)

    van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Berkhout, Stef; Polder, Johan J; Prast, Henriëtte M

    2018-02-26

    To overcome self-control difficulties, people can commit to their health goals by voluntarily accepting deadlines with consequences. In a commitment lottery, the winners are drawn from all participants, but can only claim their prize if they also attained their gym-attendance goals. In a 52-week, three-arm trial across six company gyms, we tested if commitment lotteries with behavioral economic underpinnings would promote physical activity among overweight adults. In previous work, we presented an effective 26-week intervention. In the present paper we analyzed maintenance of goal attainment at 52-week follow-up and the development of weight over time. We compared weight and goal attainment (gym attendance ≥ 2 per week) between three arms that-in the intervention period- consisted of (I) weekly short-term lotteries for 13 weeks; (II) the same short-term lotteries in combination with an additional long-term lottery after 26 weeks; and (III) a control arm without lottery-deadlines. After a successful 26-week intervention, goal attainment declined between weeks 27 and 52 in the long-term lottery arm, but remained higher than in the control group. Goal attainment did not differ between the short-term lottery arm and control arm. Weight declined slightly in all arms in the first 13 weeks of the trial and remained stable from there on. Commitment lotteries can support regular gym attendance up to 52 weeks, but more research is needed to achieve higher levels of maintenance and weight loss.

  17. Reducing Developmental Risk for Emotional/Behavioral Problems: A Randomized Controlled Trial Examining the Tools for Getting Along Curriculum

    Science.gov (United States)

    Daunic, Ann P.; Smith, Stephen W.; Garvan, Cynthia W.; Barber, Brian R.; Becker, Mallory K.; Peters, Christine D.; Taylor, Gregory G.; Van Loan, Christopher L.; Li, Wei; Naranjo, Arlene H.

    2012-01-01

    Researchers have demonstrated that cognitive-behavioral intervention strategies--such as social problem solving--provided in school settings can help ameliorate the developmental risk for emotional and behavioral difficulties. In this study, we report the results of a randomized controlled trial of Tools for Getting Along (TFGA), a social…

  18. Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

    Science.gov (United States)

    Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

    2016-01-01

    Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

  19. Yazd Breast Cancer Project Profile; A Community Based Trial for the Evaluation of Self-Examination and Physical Examination of the Breast Cancer Disease

    Directory of Open Access Journals (Sweden)

    Anthony B Miller

    2015-11-01

    Full Text Available There is some evidence to suggest that a benefit might be derived from a program that incorporated both annual physical examination of the breast (BPx and the teaching of breast self-examination (BSE. Current investigation presents the profile of a multicenter community based intervention for evaluating the effect of BSE+BPx on the reduction of morbidity and mortality due to breast cancer amongst women residing in urban areas of Yazd (Iran from 2008 to 2018. There were three distinctive phases in this trial with 10 years duration: pilot phase with the duration of 1 year, active intervention phase with 4 rounds of annual screening of BPx+BSE and follow up phase with 5 years duration. Tools of enquiry included a pre-tested questionnaire, repeated annual physical examination of the breast and more importantly mammography, sonography, and fine needle aspiration (FNA. Data were analyzed using descriptive statistics such as frequencies, percent, mean (SD, tests of chi-square and student t-test with 95% confidence level. Comparison of socio-demographic and socio-economic factors such as age, age at marriage, family size, number of live births, occupation, education level, total family income and marital status showed that no significant difference was seen between the groups (P>0.05. A response rate of 84.5% was seen by participants of the experiment group visiting the health centers for the first BPx. Our results showed that except for the education and marital status, the difference in other main demographic and socio-economic factors between the groups were not significant, and the response rate of individuals in the experiment group was at an acceptable level.

  20. Destructive examination of test plates 1 and 2 of the defects detection trials (DDT)

    International Nuclear Information System (INIS)

    Crutzen, S.; Buegers, W.; Violin, F.; Di Piazza, L.; Cowburn, K.; Sargent, T.

    1984-01-01

    The evaluation of NDT exercises results has been based on destructive examination of the plates or test blocks used during the exercise. The PISC Programme has shown that in all cases the indications given by the NDT instrumentation were corresponding to some particular defects or structure aspects in the steel or were explained by particular positions of reflectors. Generally the introduction of defects do not produce a final ''defective zone or area'' which is strictly corresponding to the intended defect. The DDT exercise management has thus decided to perform a complete destructive examination of the four plates involved in this exercise because of its experience (the PISC I exercise) and independance of commercial interest, the JRC of the CEC Ispra Establishment has been asked to do the work with the Risley Nuclear Power Development Laboratories (RNL). The present report describes the results of the destructive examination of the DDT plates 1 and 2

  1. Eugene Ogoh Abstract The study examined the relationship ...

    African Journals Online (AJOL)

    Ijomone

    Information Impact | Journal of information and knowledge management. Page 191. Eugene Ogoh. Local Government Service Commission Asaba. Abstract. The study examined the relationship between project abandonment and the socio economic lives of the people of Niger Delta. In conducting this survey research, 220 ...

  2.   Information and acceptance of prenatal examinations - a qualitative study

    DEFF Research Database (Denmark)

    Fleron, Stina Lou; Dahl, Katja; Risør, Mette Bech

    by the health care system offering it. By prenatal examinations the pregnant women want to be giving the choice of future management should there be something wrong with their child. Conclusions:Participation in prenatal examinations is not based on a thorough knowledge of pros and contra of the screening tests......  Background:In 2004 The Danish National Board of Health issued new guidelines on prenatal examinations. The importance of informed decision making is strongly emphasised and any acceptance of the screenings tests offered should be based on thorough and adequate information. Objective...... and hypothesis:To explore the influence of information in the decision-making process of prenatal screenings tests offered, the relation between information, knowledge and up-take rates and reasons for accepting or declining the screenings tests offered.  Methods:The study is based on a qualitative approach...

  3. The physics secondary education certificate examination: A Maltese case study

    Science.gov (United States)

    Chetcuti, Deborah A.

    This thesis investigates whether examinations are fair and just for all students in Maltese schools within the context of the Physics Secondary Education Certificate. It explores what teachers and students think of the Physics SEC examination, how the teachers' and students' views were reflected in the kind of teaching and learning taking place in the schools and how the examinations impacted on the lives of students and whether there were any differences in gender and class which limited the experiences of students. The data was obtained from observations and interviews carried out with teachers and students in six Maltese schools representing a girls' and boys' Private School, Junior Lyceum and Area Secondary School. Examination results obtained from the MATSEC Support Unit were also statistically analysed. The study uses these multiple sources of data to explore the complex patterns involved. It is reflective and reflexive throughout and tries to intertwine the subjectivity of the researcher with both the data being collected as well as with the research process itself. The evidence from the data suggests that assessment practices in Maltese classrooms are still very much grounded within an examination culture. This leads to teaching to the test and shallow learning. While there are no significant gender differences in achievement, type of school related to the differentiated paper system emerges out of the data as being very influential in determining the performance and future opportunities of students. This indicates that examinations are not fair and just for all students in Maltese schools and points to the need for a new model of educational assessment focusing on positive achievement rather than selection and control. The study suggests how this new model can be implemented within the context of Maltese classrooms taking into consideration the views of the teachers and students involved in assessment.

  4. Destructive examination of test plates 3 and test piece 4 of the defects detection trials (DDT)

    International Nuclear Information System (INIS)

    Buegers, W.; Crutzen, S.; Pisoni, A.; Violin, F.; Di Piazza, L.; Lock, D.; Sargent, T.

    1984-01-01

    The evaluation of NDT exercises results has been based on destructive examination of the plates or test blocks used during the exercise. The PISC I Programme has shown that in all cases the indications given by the NDT instrumentation were corresponding to some particular defects or structure aspects in the steel or were explained by particular positions of reflectors. Generally the introduction of defects using techniques such as: - implantation of modules, - introduction of non metallic material, - introduction of poison in the weld, do not produce a final ''detective zone or area'' which is strictly corresponding to the intended defect. The DDT exercise management has thus decided to perform a complete destructive examination of the four plates involved in this exercise because of its experience (the PISC I exercise) and independance of commercial interest, the JRC of the CEC, Ispra Establishment, has been asked to do the work in collaboratione with the Risley Nuclear Power development Laboratories (RNL). A collaboration agreement has been signed between RNL and JRC. Operating Agent of the PISC II programme, is interested in having a direct access to data to be added to those furnished by PISC. The present report describes the results of the destructive examination of the DDT plates 3 and 4

  5. Trial examination of direct pebble fabrication for advanced tritium breeders by the emulsion method

    Energy Technology Data Exchange (ETDEWEB)

    Hoshino, Tsuyoshi, E-mail: hoshino.tsuyoshi@jaea.go.jp

    2014-10-15

    Highlights: • The integration of raw material preparation and granulation is proposed as a new direct pebble fabrication process. • The emulsion method granulates gel spheres of Li{sub 2}CO{sub 3} and TiO{sub 2} or SiO{sub 2}. • The gel spheres are calcined and sintered in air. • The crush load of the sintered Li{sub 2}TiO{sub 3} or Li{sub 4}SiO{sub 4} pebbles obtained is 37.2 or 59.3 N, respectively. - Abstract: Demonstration power plant reactors require advanced tritium breeders with high thermal stability. For the mass production of advanced tritium breeder pebbles, pebble fabrication by the emulsion method is a promising technique. To develop the most efficient pebble fabrication method, a new direct pebble fabrication process utilizing the emulsion method was implemented. A prior pebble fabrication process consisted of the preparation of raw materials followed by granulation. The new process integrates the preparation and granulation of raw materials. The slurry for the emulsion granulation of Li{sub 2}TiO{sub 3} or Li{sub 4}SiO{sub 4} as a tritium breeder consists of mixtures of Li{sub 2}CO{sub 3} and TiO{sub 2} or SiO{sub 2} at specific ratios. Subsequently, gel spheres of tritium breeders are fabricated by controlling the relative flow speeds of slurry and oil. The average diameter and crush load of the obtained sintered Li{sub 2}TiO{sub 3} or Li{sub 4}SiO{sub 4} pebbles were 1.0 or 1.5 mm and 37.2 or 59.3 N, respectively. The trial fabrication results suggest that the new process has the potential to increase the fabrication efficiency of advanced tritium breeder pebbles.

  6. Total Cardiovascular Events Analysis of the EXAMINE Trial in Patients with Type 2 Diabetes and Recent Acute Coronary Syndrome.

    Science.gov (United States)

    Cavender, Matthew A; White, William B; Liu, Yuyin; Massaro, Joseph M; Bergenstal, Richard M; Mehta, Cyrus R; Zannad, Faiez; Heller, Simon; Cushman, William C; Cannon, Christopher P

    2018-04-13

    Alogliptin, a dipeptidyl-peptidase 4 inhibitor, is approved for the treatment of patients with type 2 diabetes. EXAMINE was a randomized-controlled clinical trial designed to demonstrate the cardiovascular safety of alogliptin. In the trial, 5380 patients with established T2DM who had a recent ACS event (between 15-90 days) were randomized to treatment with either alogliptin or placebo. To better understand and describe the cardiovascular (CV) safety of alogliptin, we analyzed data from the EXAMINE randomized clinical trial to determine whether treatment with alogliptin affected recurrent and total CV events. Poisson regression analysis was performed to compare the total number of occurrences of CV death, MI, stroke, unstable angina, and coronary revascularization between all patients randomized to alogliptin versus placebo groups. Patients with recurrent CV events were older and more likely to have renal disease and history of heart failure. There were 1100 first CV events and an additional 666 recurrent events over a median of 18 months of follow-up. There were no significant differences with regard to the total number of events in patients treated with alogliptin (n=873) or placebo (n=893; p=0.52). Furthermore, there were no differences in the types of events seen in patients treated with alogliptin or placebo. Alogliptin did not increase the risk of either first or recurrent CV events when compared to placebo in patients with type 2 diabetes and recent ACS. These data support the CV safety of alogliptin in patients who are at increased risk of future CV events. This article is protected by copyright. All rights reserved.

  7. A randomized clinical trial comparing plaque removal efficacy of an oscillating-rotating power toothbrush to a manual toothbrush by multiple examiners.

    Science.gov (United States)

    Kurtz, B; Reise, M; Klukowska, M; Grender, J M; Timm, H; Sigusch, B W

    2016-11-01

    To determine whether multiple examiners can demonstrate consistent plaque removal advantages for an oscillating-rotating power toothbrush versus a manual toothbrush. This was a replicate-use, single brushing, examiner-blind, randomized, two-treatment, four-period crossover clinical trial involving four examiners. Subjects were randomized to one of four treatment sequences involving two toothbrushes: an oscillating-rotating power toothbrush or a manual toothbrush. At each of the four visits, subjects arrived having abstained from oral hygiene for 24 h prior, and brushed with their assigned toothbrush and a marketed fluoride dentifrice under supervision unaided by a mirror. Plaque was assessed by each examiner using the Turesky-Modified Quigley-Hein Plaque Index at each study period before and after brushing. Data was analysed separately for each examiner using the analysis of covariance for crossover design. Ninety-five subjects between the ages of 18 and 70 met the entrance criteria and were enrolled in the study. Eighty-seven subjects completed all four periods of the study. Both brushes delivered a significant plaque reduction when compared to baseline. Significant treatment differences were observed for all four examiners - ranging from 0.10 to 0.16 - in favor of the oscillating-rotating brush (P toothbrush removed significantly more plaque after a single brushing than the standard manual toothbrush. Both brushes were well tolerated. © 2016 The Authors. International Journal of Dental Hygiene Published by John Wiley & Sons Ltd.

  8. iPad-based patient briefing for radiological examinations-a clinical trial.

    Science.gov (United States)

    Schlechtweg, Philipp M; Hammon, Matthias; Giese, David; Heberlein, Christian; Uder, Michael; Schwab, Siegfried A

    2014-08-01

    To analyze if an iPad-based patient briefing can serve as a digital alternative to conventional documentations prior to radiological examinations. One hundred one patients referred for routine MRI were randomized into two groups, who underwent iPad-based and classic written briefing in opposite order. For each briefing completion time, completeness and correctness were noted. Patient's knowledge about the content of either briefing modality was subsequently tested. The influence of patient-related factors on the performance of the electronic briefing (EB) was analyzed. Finally, the patient's subjective impression of the EB was assessed. The mean durations were 4.4 ± 2.2 min for EB and 1.7 ± 1.3 min for the classic briefing (p iPad briefings were returned entirely filled out, whereas 11 % of the classic forms were returned with missing data. No significant differences in memorization of the briefing's information were objectified. There was a positive correlation between the duration of EB and age (r = 0.53; p iPads transfers the information for the patients equally well compared to the classic written approach. Although iPad briefing took patients longer to perform, the majority would prefer it to written consent briefings in the future. Nevertheless, measures have to be undertaken to improve the overall acceptance and performance.

  9. A clinical trial to examine disparities in quitting between African-American and White adult smokers: Design, accrual, and baseline characteristics.

    Science.gov (United States)

    Nollen, Nicole L; Cox, Lisa Sanderson; Yu, Qing; Ellerbeck, Edward F; Scheuermann, Taneisha S; Benowitz, Neal L; Tyndale, Rachel F; Mayo, Matthew S; Ahluwalia, Jasjit S

    2016-03-01

    African-Americans smoke fewer cigarettes per day than Whites but experience greater smoking attributable morbidity and mortality. African-American-White differences may also exist in cessation but rigorously designed studies have not been conducted to empirically answer this question. Quit2Live is, to our knowledge, the first head-to-head trial designed with the primary aim of examining African-American-White disparities in quitting smoking. Secondary aims are to identify mechanisms that mediate and/or moderate the relationship between race and quitting. The study is ongoing. Study aims are accomplished through a 5-year prospective cohort intervention study designed to recruit equal numbers of African-Americans (n=224) and Whites (n=224) stratified on age (White disparities in quitting smoking exist but, more importantly, will examine mechanisms underlying the difference. Attention to proximal, modifiable mechanisms (e.g., adherence, response to treatment, depression, stress) maximizes Quit2Live's potential to inform practice. Findings will provide an empirically-derived approach that will guide researchers and clinicians in identifying specific factors to address to improve cessation outcomes and reduce tobacco-related morbidity and mortality in African-American and White smokers. ClinicalTrials.gov: NCT01836276. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. 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.

  11. Physical activity as an aid to smoking cessation during pregnancy (LEAP trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ussher Michael

    2012-10-01

    Full Text Available Abstract Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. Methods/design The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy, and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations. The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. Discussion This trial will assess whether a PA intervention is effective when used for

  12. [Validity of partial systems of periodontal examination in epidemiological studies].

    Science.gov (United States)

    Sicilia, A; Ainamo, J; Noguerol, B; Cobo, J; Lucas, V; Bascones, A

    1990-06-01

    The purpose of the present study was to determine the representativeness of partial examination in the assessment of the average severity and the prevalence of periodontal disease. 343 subjects aged 7, 12 and 15-19 years were examined for the presence or absence of gingival bleeding after gentle probing, supra or subgingival calculus and pocket depths of 4-5 mm., or 6 mm. and over, of each tooth. Three sets of average severity and prevalence scores were prepared: based on the full mouth examination, on observations made from the index teeth of the P.D.I., and on the six teeth utilized for the C.P.I.T.N. in this age group. Partial indices tended to underestimate the real prevalence of the different signs, and slightly overestimate severity, being these observations statistically significant. Average severity scores were obtained more accurately with the six Ramfjord teeth, while real prevalence rates were better determined with the C.P.I.T.N. teeth. From an epidemiological point of view, the real significance of the differences observed should be further determined.

  13. Challenges in translating end points from trials to observational cohort studies in oncology

    Directory of Open Access Journals (Sweden)

    Ording AG

    2016-06-01

    Full Text Available Anne Gulbech Ording,1 Deirdre Cronin-Fenton,1 Vera Ehrenstein,1 Timothy L Lash,1,2 John Acquavella,1 Mikael Rørth,1 Henrik Toft Sørensen1 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA Abstract: Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues – including previously unrecognized concerns – by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints. Keywords: endpoint determination, medical oncology

  14. Examining the factor structure of the Clinical Opiate Withdrawal Scale: A secondary data analysis from the National Drug Abuse Treatment Clinical Trials Network (CTN) 0003.

    Science.gov (United States)

    Barbosa-Leiker, Celestina; McPherson, Sterling; Mamey, Mary Rose; Burns, G Leonard; Layton, Matthew E; Roll, John; Ling, Walter

    2015-07-01

    The Clinical Opiate Withdrawal Scale (COWS) is used to assess withdrawal in clinical trials and practice. The aims of this study were to examine the inter-item correlations and factor structure of the COWS in opioid-dependent men and women. This is a secondary data analysis of the National Drug Abuse Treatment Clinical Trials Network 0003, a randomized clinical trial that compared buprenorphine/naloxone tapering strategies. The trial included 11 sites in 10 US cities. Participants were opioid-dependent individuals (n=516) that had data on the COWS. The COWS at study baseline was analyzed in this study. Inter-item correlations showed weak to moderate relationships among the items. A 1-factor model did not fit the data for men (comparative fit index (CFI)=.801, root mean square error of approximation (RMSEA)=.073, weighted root mean square residual (WRMR)=1.132) or women (CFI=.694, RMSEA=.071, WRMR=.933), where resting pulse rate was not related to withdrawal for men, and yawning and gooseflesh skin was not related to withdrawal for women. A reduced model comprised of only the 8 items that were significantly related to the construct of withdrawal in both men and women, and an exploratory 2-factor model, were also assessed but not retained due to inconsistencies across gender. When traditional psychometric models are applied to the COWS, it appears that the scale may not relate to a single underlying construct of withdrawal. Further research testing the hypothesized factor structure in other opioid-dependent samples is needed. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. Melatonin for Sleep in Children with Autism: A Controlled Trial Examining Dose, Tolerability, and Outcomes

    Science.gov (United States)

    Malow, Beth; Adkins, Karen W.; McGrew, Susan G.; Wang, Lily; Goldman, Suzanne E.; Fawkes, Diane; Burnette, Courtney

    2012-01-01

    Supplemental melatonin has shown promise in treating sleep onset insomnia in children with autism spectrum disorders (ASD). Twenty-four children, free of psychotropic medications, completed an open-label dose-escalation study to assess dose-response, tolerability, safety, feasibility of collecting actigraphy data, and ability of outcome measures…

  16. Drill-back studies examine fractured, heated rock

    International Nuclear Information System (INIS)

    Wollenberg, H.A.; Flexser, S.; Myer, L.R.

    1990-01-01

    To investigate the effects of heating on the mineralogical, geochemical, and mechanical properties of rock by high-level radioactive waste, cores are being examined from holes penetrating locations where electric heaters simulated the presence of a waste canister, and from holes penetration natural hydrothermal systems. Results to date indicate the localized mobility and deposition of uranium in an open fracture in heated granitic rock, the mobility of U in a breccia zone in an active hydrothermal system in tuff, and the presence of U in relatively high concentration in fracture-lining material in tuff. Mechanical -- property studies indicate that differences in compressional- and shear-wave parameters between heated and less heated rock can be attributed to differences in the density of microcracks. Emphasis has shifted from initial studies of granitic rock at Stripa, Sweden to current investigations of welded tuff at the Nevada Test Site. 7 refs., 8 figs

  17. Can students learn clinical method in general practice? A randomised crossover trial based on objective structured clinical examinations.

    Science.gov (United States)

    Murray, E.; Jolly, B.; Modell, M.

    1997-01-01

    OBJECTIVE: To determine whether students acquired clinical skills as well in general practice as in hospital and whether there was any difference in the acquisition of specific skills in the two environments. DESIGN: Randomised crossover trial. SUBJECTS AND SETTING: Annual intake of first year clinical students at one medical school. INTERVENTION: A 10 week block of general internal medicine, one half taught in general practice, the other in hospital. Students started at random in one location and crossed over after five weeks. OUTCOME MEASURES: Students' performance in two equivalent nine station objective structured clinical examinations administered at the mid and end points of the block: a direct comparison of the two groups' performance at five weeks; analysis of covariance, using their first examination scores as a covariate, to determine students' relative improvement over the second five weeks of their attachment. RESULTS: 225 students rotated through the block; all took at least one examination and 208 (92%) took both. For the first half of the year there was no significant difference in the students' acquisition of clinical skills in the two environments; later, however, students taught in general practice improved slightly more than those taught in hospital (P = 0.007). CONCLUSIONS: Students can learn clinical skills as well in general practice as in hospital; more work is needed to clarify where specific skills, knowledge, and attitudes are best learnt to allow rational planning of the undergraduate curriculum. PMID:9361543

  18. A randomized-clinical trial examining a neoprene abdominal binder in gynecologic surgery patients

    Science.gov (United States)

    Szender, J.B.; Hall, K.L.; Kost, E.R.

    2016-01-01

    Summary Purpose of Investigation Pain control and early ambulation are two important postoperative goals. Strategies that decrease morphine use while increasing ambulation have the potential to decrease postoperative complications. In this study the authors sought to determine the effect of an abdominopelvic binder on postoperative morphine use, pain, and ambulation in the first day after surgery. Materials and Methods The authors randomly assigned 75 patients undergoing abdominal gynecologic surgery to either binder or not after surgery. Demographic data and surgical characteristics were collected. Outcome variables included morphine use, pain score, time to ambulation, and number of ambulations. Results A group at high risk for decreased mobility was identified and the binder increased the number of ambulatory events by 300%, 260%, and 240% in patients with vertical incisions, age over 50 years, and complex surgeries, respectively. Morphine use and pain scores were not significantly different. Conclusion The binder increased ambulations in the subset of patients at the highest risk for postoperative complications: elderly, cancer patients, and vertical incisions. Routine use of the binder may benefit particularly high-risk gynecologic surgical patients. PMID:25864252

  19. Randomized clinical trial examining the effect of music therapy in stress response to day surgery.

    Science.gov (United States)

    Leardi, S; Pietroletti, R; Angeloni, G; Necozione, S; Ranalletta, G; Del Gusto, B

    2007-08-01

    Music therapy could reduce stress and the stress response. The aim of this study was to investigate the role of music therapy in alleviating stress during day surgery. Sixty patients undergoing day surgery were randomized to one of three groups, each containing 20 patients. Before and during surgery, patients in group 1 listened to new age music and those in group 2 listened to a choice of music from one of four styles. Patients in group 3 (control group) heard the normal sounds of the operating theatre. Plasma levels of cortisol and subpopulations of lymphocytes were evaluated before, during and after operation. Plasma cortisol levels decreased during operation in both groups of patients who listened to music, but increased in the control group. Postoperative cortisol levels were significantly higher in group 1 than in group 2 (mean(s.d.) 14.21(6.96) versus 8.63(2.72) ng/dl respectively; P < 0.050). Levels of natural killer lymphocytes decreased during surgery in groups 1 and 2, but increased in controls. Intraoperative levels of natural killer cells were significantly lower in group 1 than in group 3 (mean(s.d.) 212.2(89.3) versus 329.1(167.8) cells/microl; P < 0.050). Perioperative music therapy changed the neurohormonal and immune stress response to day surgery, especially when the type of music was selected by the patient. Copyright (c) 2007 British Journal of Surgery Society Ltd.

  20. Recall rate reduction with tomosynthesis during baseline screening examinations – an assessment from a prospective trial

    Science.gov (United States)

    Sumkin, Jules H.; Ganott, Marie A.; Chough, Denise M.; Catullo, Victor J.; Zuley, Margarita L.; Shinde, Dilip D.; Hakim, Christiane M.; Bandos, Andriy I.; Gur, David

    2015-01-01

    Rational and Objectives Assess results of a prospective, single site clinical study evaluating digital breast tomosynthesis (DBT) during baseline screening mammography. Materials and Methods Under an institutional review board approved HIPAA compliant protocol, consenting women between ages 34 and 56 scheduled for their initial/baseline screening mammogram underwent both Full Field Digital Mammography (FFDM) and DBT. The FFDM and the FFDM plus DBT images were interpreted independently in a reader by mode balanced approach by two of 14 participating radiologists. A woman was recalled for a diagnostic workup if either radiologist recommended a recall. We report overall recall rates and related diagnostic outcome from the 1080 participants. Proportion of recommended recalls (BIRADS 0) were compared using a generalized linear mixed model (SAS 9.3) with a significance level of p=0.0294. Results The fraction of women without breast cancer recommended for recall using FFDM alone and FFDM plus DBT were 412/1074 (38.4%) and 274/1074 (25.5%), respectively (p<0.001). Large inter-reader variability in terms of recall reduction was observed among the 14 readers; however, 11 out of 14 readers recalled fewer women using FFDM plus DBT (5 with p-values <0.015). Six cancers (4 DCIS and 2 IDC) were detected. One IDC was detected only on DBT and one DCIS cancer was detected only on FFDM, while the remaining cancers were detected on both modalities. Conclusion The use of FFDM plus DBT resulted in a significant decrease in recall rates during baseline screening mammography with no reduction in sensitivity. PMID:26391857

  1. General Studies Advancement Examinations in Writing and Mathematics.

    Science.gov (United States)

    Johnson, De S.; Deduck, Patricia

    To continue upper division coursework past 15 credit hours, students at Southwest Texas State University must pass the College Level Examination Program (CLEP) General Examination in English Composition with Essay, with a minimum score of 421 and 45 semester hours of credit, and the CLEP General Examination in Mathematics, with a minimum score of…

  2. Sedation for pediatric neuroradiological examinations. Retrospective study of 160 cases

    International Nuclear Information System (INIS)

    Shose, Yoshiteru; Oi, Shizuo

    1995-01-01

    A retrospective study of 160 pediatric neuroradiological examinations was conducted to determine the efficacy and safety of two sedation regimens (figs. 1, 2). For CT purposes, 150 patients (fig. 3) were orally given monosodium trichlorethyl phosphate syrup (100 mg/kg, with repeat 50 mg/kg if necessary), and for cerebral angiography, 15 patients (fig. 4) were intramuscularly administered a modified D.P.T. cocktail (pentazocine, chlorpromadine, promethazine). Failure rate in the oral syrup group was 6%, and in the D.P.T. group 6.7%. Diagnostic-quality images were obtained in 99.3% and 100%, respectively, of the two groups. There were neither mortality nor significant complications (table 3). It was concluded that each method had proved acceptably safe and effective, and that measures can be taken to further decrease complications and sedation failures. (author)

  3. A feasibility study on a tomograph for radioactive waste examination

    International Nuclear Information System (INIS)

    Montigon, J.F.

    1987-01-01

    A feasibility study on a high-energy tomograph for radioactive waste examination has been carried out by CEA/SEDFMA (Cadarache, France). After describing the scope of the research (radiation source, detector system, data processing, station mechanics), this final report deals with the work programme which has been followed and gives the results of the research. The conclusion is that such a tomograph is feasible, and its preliminary design is shown. The main points are that: - the detector material will be BGO, - the transmission of gamma rays through concrete (up to 1 625 mm thick) has been measured and a calculation code has been validated, - the radiation source will be an accelerator which has to be carefully optimized, - the system configuration has been determined and the data processors have been chosen, - the algorithms for image reconstruction have been validated through taking a tomogram on a concrete sample

  4. [Implementation of bedside training and advanced objective structured clinical examination (OSCE) trial to learn and confirm about pharmacy clinical skills].

    Science.gov (United States)

    Tokunaga, Jin; Takamura, Norito; Ogata, Kenji; Setoguchi, Nao; Sato, Keizo

    2013-01-01

    Bedside training for fourth-year students, as well as seminars in hospital pharmacy (vital sign seminars) for fifth-year students at the Department of Pharmacy of Kyushu University of Health and Welfare have been implemented using patient training models and various patient simulators. The introduction of simulation-based pharmaceutical education, where no patients are present, promotes visually, aurally, and tactilely simulated learning regarding the evaluation of vital signs and implementation of physical assessment when disease symptoms are present or adverse effects occur. A patient simulator also promotes the creation of training programs for emergency and critical care, with which basic as well as advanced life support can be practiced. In addition, an advanced objective structured clinical examination (OSCE) trial has been implemented to evaluate skills regarding vital signs and physical assessments. Pharmacists are required to examine vital signs and conduct physical assessment from a pharmaceutical point of view. The introduction of these pharmacy clinical skills will improve the efficacy of drugs, work for the prevention or early detection of adverse effects, and promote the appropriate use of drugs. It is considered that simulation-based pharmaceutical education is essential to understand physical assessment, and such education will ideally be applied and developed according to on-site practices.

  5. Early studies of instant-fMRI for routine examination

    International Nuclear Information System (INIS)

    Sakurai, Yuuki; Harada, Kuniaki; Nagahama, Hiroshi; Akatsuka, Yoshihiro; Shinozaki, Jun

    2010-01-01

    Authors are developing a low-burden, short-time acquisition method of functional magnetic resonance imaging (fMRI) with 3T machine, named ''Instant-fMRI'', aiming for its application to routine examinations, of which results of early studies on identification of the language hemisphere are reported. Subjects were 10 healthy volunteers (8 males, 2 females, mean age 34.2 y, 8 right-handers) and 5 right-hander patients with brain tumor (4 males, 1 female, mean age 50 y). The machine was GE Signa HDx 3.0T ver. 14, using 8 channel head coil. For Instant-fMRI, T1-weighted imaging sequence for mapping was in fast spoiled gradient recalled acquisition in the steady state (fSPGR) mode (scan time: 1 min 44 sec) and fMRI sequence, in GRE-EPI (scan time: 1 min), which thus required only about 3 min in total. Reference was defined to be the anterior-posterior commissure line, to which parallel sections involving centriciput and cerebellum were acquired. Rest (30 sec)-task (shiritori language game, 30 sec) cycle was to be one in instant-fMRI in contrast to three in the conventional fMRI. Volunteers received both instant-fMRI and conventional fMRI and patients, the former alone. Data were analyzed by GE Brain Wave PA. Right and left hemisphere of the left and right hander, respectively, was identified to be activated by instant-fMRI in 9 of 10 volunteers and in all patients, and by the conventional fMRI, in all volunteers. The instant-fMRI can be a useful examination of other brain functions as well as identifying the language field when acquisition parameters for desired diagnostic purpose are optimized. (T.T.)

  6. Clinical Trials

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore ...

  7. Body Size-Specific Organ and Effective Doses of Chest CT Screening Examinations of the National Lung Screening Trial.

    Science.gov (United States)

    Lee, Choonsik; Flynn, Michael J; Judy, Phillip F; Cody, Dianna D; Bolch, Wesley E; Kruger, Randell L

    2017-05-01

    We calculated body size-specific organ and effective doses for 23,734 participants in the National Lung Screening Trial (NLST) using a CT dose calculator. We collected participant-specific technical parameters of 23,734 participants who underwent CT in the clinical trial. For each participant, we calculated two sets of organ doses using two methods. First, we computed body size-specific organ and effective doses using the National Cancer Institute CT (NCICT) dosimetry program, which is based on dose coefficients derived from a library of body size-dependent adult male and female computational phantoms. We then recalculated organ and effective doses using dose coefficients from reference size phantoms for all examinations to investigate potential errors caused by the lack of body size consideration in the dose calculations. The underweight participants (body mass index [BMI; weight in kilograms divided by the square of height in meters] dose (median, 4.93 mGy) than the obese participants (BMI > 30) (3.90 mGy). Thyroid doses were approximately 1.3- to 1.6-fold greater than the lung doses (6.3-6.5 mGy). The reference phantom-based dose calculation underestimates the body size-specific lung dose by up to 50% for the underweight participants and overestimates that value by up to 200% for the overweight participants. The median effective dose ranges from 2.01 mSv in obese participants to 2.80 mSv in underweight participants. Body size-specific organ and effective doses were computed for 23,734 NLST participants who underwent low-dose CT screening. The use of reference size phantoms can lead to significant errors in organ dose estimates when body size is not considered in the dose assessment.

  8. High-sensitivity C-reactive protein, low-density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial.

    Science.gov (United States)

    Hwang, You-Cheol; Morrow, David A; Cannon, Christopher P; Liu, Yuyin; Bergenstal, Richard; Heller, Simon; Mehta, Cyrus; Cushman, William; Bakris, George L; Zannad, Faiez; White, William B

    2018-03-01

    We sought to assess the risk of major adverse cardiovascular events (MACE) by utilizing high-sensitivity C-reactive protein (hsCRP) level and low-density lipoprotein cholesterol (LDL-C) in patients with type 2 diabetes and recent acute coronary syndrome. Study participants enrolled in the EXAMINE trial (Clinical trials registration number: NCT00968708) and were stratified by baseline hsCRP levels (3 mg/L). They were also sub-divided into 4 groups according to baseline hsCRP (≤3 or >3 mg/L) and achieved LDL-C (3 mg/L, respectively (P 3 mg/L, the adjusted hazard ratio (95% confidence interval) was 1.42 (1.13, 1.78; P = .002) for MACE compared with patients with hsCRP C and low hsCRP, low LDL-C and high hsCRP, high LDL-C and low hsCRP, and high LDL-C and high hsCRP levels, respectively (P C level. © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  9. Examining the effectiveness of home-based parent aide services to reduce risk for physical child abuse and neglect: six-month findings from a randomized clinical trial.

    Science.gov (United States)

    Guterman, Neil B; Tabone, Jiyoung K; Bryan, George M; Taylor, Catherine A; Napoleon-Hanger, Cynthia; Banman, Aaron

    2013-08-01

    This study set out to carry out a feasible, real-world, randomized clinical trial to examine the benefits of home-based paraprofessional parent aide services in reducing physical abuse and neglect risk in high-risk parents. Families were randomly assigned to receive either parent aide plus case management services (n = 73) or case management services only (n = 65), collecting in-home data on physical child abuse and neglect and proximal risk and protective factors, just prior to service initiation, and again after six months of services. Mothers receiving parent aide and case management services reported significant improvements from baseline to six-month follow-up in self-reported indicators of physical child abuse risk, as well as improvements on parental stress, mastery, depression, and anxiety, whereas mothers receiving only case management services did not. The slopes of such observed changes across groups, however, were not found to be statistically significantly different. No discernable improvements were found with regard to indicators of risk for child neglect. As the first randomized clinical trial examining the effectiveness of parent aide services, this study provides the first controlled evidence examining the potential benefits of this service modality. This study suggests promising trends regarding the benefit of parent aide services with respect to physical child abuse risk reduction and related predictors, but evidence does not appear to suggest that such services, as they are presently delivered, reduce child neglect. These findings support the continued use of parent aide services in cases of physical child abuse and also suggest careful consideration of the ways such services may be better configured to extend their impact, particularly with respect to child neglect risk. Copyright © 2013 Elsevier Ltd. All rights reserved.

  10. Clinical trial allocation in multinational pharmaceutical companies - a qualitative study on influential factors.

    Science.gov (United States)

    Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik; Thomsen, Simon F

    2017-06-01

    Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities. The results suggest that headquarters and regional departments are key decision makers during country selection, whereas subsidiaries decide on site selection. Study participants argued that headquarters primarily value timely patient recruitment and quality of data when assessing subsidiaries. The site-related qualities most commonly emphasized during interviews were study population availability, timely patient recruitment, resources at the site, and site personnel's interest and commitment. Costs of running the trials were described as less important. Site personnel experience in conducting trials was described as valuable but not imperative. In conclusion, multinational pharmaceutical companies consider recruitment-related factors as crucial when allocating clinical trials. Quality of data and site personnel's interest and commitment are also essential, whereas costs seem less important. While valued, site personnel experience in conducting clinical trials is not imperative.

  11. The practice of testicular self examination: a comparative study of ...

    African Journals Online (AJOL)

    The practice of testicular self examination was investigated amongst a sample of 170 British and 153 Zimbabwean male undergraduates using a questionnaire based on the health belief model. Knowledge of testicular cancer and of self examination was found to be low in both groups. Both groups, though, showed high ...

  12. Epidemiological Study and Control Trial of Taeniid Cestode Infection in Farm Dogs in Qinghai Province, China

    OpenAIRE

    GUO, Zhihong; LI, Wei; PENG, Mao; DUO, Hong; SHEN, Xiuying; FU, Yong; IRIE, Takao; GAN, Tiantian; KIRINO, Yumi; NASU, Tetsuo; HORII, Yoichiro; NONAKA, Nariaki

    2013-01-01

    ABSTRACT An epidemiological study and control trial were conducted to assess taeniid infection in farm dogs in Qinghai Province, China. To improve egg detection by fecal examination, a deworming step with praziquantel was incorporated into the sampling methodology. As a result, a marked increase in the number of egg-positive samples was observed in samples collected at 24 hr after deworming. Then, the fecal examination and barcoding of egg DNA were performed to assess the prevalence of taenii...

  13. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study.

    Science.gov (United States)

    Barbour, Virginia; Burch, Druin; Godlee, Fiona; Heneghan, Carl; Lehman, Richard; Perera, Rafael; Ross, Joseph S; Schroter, Sara

    2016-01-21

    Analysis of trial documentation has revealed that some industry-funded trials may be done more for marketing purposes than scientific endeavour. We aimed to define characteristics of drug trials that appear to be influenced by marketing considerations and estimate their prevalence. We examined reports of randomised controlled trials of drugs published in six general medical journals in 2011. Six investigators independently reviewed all publications, characterising them as YES/MAYBE/NO suspected marketing trials, and then met to reach consensus. Blinded researchers then extracted key trial characteristics. We used blinded cluster analysis to determine if key variables could characterise the categories of trials (YES/MAYBE/NO). 41/194 (21 %) trials were categorised as YES, 14 (7 %) as MAYBE, 139 (72 %) as NO. All YES and MAYBE trials were funded by the manufacturer, compared with 37 % of NO trials (p marketing purposes. Each of the marketing trials appeared to have a unique combination of features reported in the journal publications.

  14. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement

    DEFF Research Database (Denmark)

    Sørensen, Mona Have; Nielsen, Jacob Have; Gejl, Anne Kær

    2016-01-01

    -based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. METHODS: The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools...... in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention...... a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF) questionnaire filled out by the parents), creativity (using the Torrance Tests of Creative Thinking, TTCT), aerobic fitness (by the Andersen intermittent shuttle-run test) and body mass index. PA during math...

  15. TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial.

    Science.gov (United States)

    Watson, Gillian; O'Hara, James; Carding, Paul; Lecouturier, Jan; Stocken, Deborah; Fouweather, Tony; Wilson, Janet

    2016-04-01

    Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for attendance at a secondary care throat or voice clinic. There is a growing trend to treat throat symptom patients with proton pump inhibitors (PPIs) to suppress stomach acid, but most controlled studies fail to demonstrate a significant benefit of PPI over placebo. In addition, patient views on PPI use vary widely. A UK multi-centre, randomised, controlled trial for adults with persistent throat symptoms to compare the effectiveness of treatment with the proton pump inhibitor (PPI) lansoprazole versus placebo. The trial includes a six-month internal pilot, during which three sites will recruit 30 participants in total, to assess the practicality of the trial and assess the study procedures and willingness of the patient population to participate. If the pilot is successful, three additional sites will be opened to recruitment, and a further 302 participants recruited across the six main trial sites. Further trial sites may be opened, as necessary. The main trial will continue for a further 18 months. Participants will be followed up for 12 months from randomisation, throughout which both primary and secondary outcome data will be collected. The primary outcome is change in Reflux Symptom Index (RSI) score, the 'area standard' for this type of assessment, after 16 weeks (four months) of treatment. Secondary outcomes are RSI changes at 12 months after randomisation, Quality of Life assessment at four and 12 months, laryngeal mucosal changes, assessments of compliance and side effects, and patient-reported satisfaction. TOPPITS is designed to evaluate the relative effectiveness of treatment with a proton pump inhibitor versus placebo in patients with persistent throat symptoms. This will provide valuable information to clinicians and GPs regarding the treatment and management of care for these patients, on changes in symptoms, and in Quality of Life, over time. ISRCTN

  16. Bridging case-control studies and randomized trials

    Directory of Open Access Journals (Sweden)

    Rosendaal Frits R

    2001-05-01

    Full Text Available Abstract Randomized trials and observational studies, such as case-control studies, are often seen as opposing approaches. However, in many instances results obtained by different designs may complement each other. For instance, case-control studies on aetiology of disease may help to give the direction of future trials. In this commentary, the author discusses the purpose of randomization and observation, and under which conditions one design may be preferred to another. Randomization is useful to combat 'confounding by indication', and is therefore the design of choice for most therapeutic trials. When this confounding is not an issue, as in studies of genetic risk factors or side-effects, then case-control studies are preferred.

  17. A Novel Biomarker Panel Examining Response to Gemcitabine with or without Erlotinib for Pancreatic Cancer Therapy in NCIC Clinical Trials Group PA.3.

    Directory of Open Access Journals (Sweden)

    David B Shultz

    Full Text Available NCIC Clinical Trials Group PA.3 was a randomized control trial that demonstrated improved overall survival (OS in patients receiving erlotinib in addition to gemcitabine for locally advanced or metastatic pancreatic cancer. Prior to therapy, patients had plasma samples drawn for future study. We sought to identify biomarkers within these samples.Using the proximity ligation assay (PLA, a probe panel was built from commercially available antibodies for 35 key proteins selected from a global genetic analysis of pancreatic cancers, and used to quantify protein levels in 20 uL of patient plasma. To determine if any of these proteins levels independently associated with OS, univariate and mulitbaraible Cox models were used. In addition, we examined the associations between biomarker expression and disease stage at diagnosis using Fisher's exact test. The correlation between Erlotinib sensitivity and each biomarkers was assessed using a test of interaction between treatment and biomarker.Of the 569 eligible patients, 480 had samples available for study. Samples were randomly allocated into training (251 and validation sets (229. Among all patients, elevated levels of interleukin-8 (IL-8, carcinoembryonic antigen (CEA, hypoxia-inducible factor 1-alpha (HIF-1 alpha, and interleukin-6 were independently associated with lower OS, while IL-8, CEA, platelet-derived growth factor receptor alpha and mucin-1 were associated with metastatic disease. Patients with elevated levels of receptor tyrosine-protein kinase erbB-2 (HER2 expression had improved OS when treated with erlotinib compared to placebo. In conclusion, PLA is a powerful tool for identifying biomarkers from archived, small volume serum samples. These data may be useful to stratify patient outcomes regardless of therapeutic intervention.ClinicalTrials.gov NCT00040183.

  18. Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major

    DEFF Research Database (Denmark)

    Jakobsen, Janus Christian

    2014-01-01

    trial received similar antidepressants as co-interventions. All trials had high risk of bias. Four trials assessed "interpersonal psychotherapy" and one trial "short psychodynamic supportive psychotherapy". Both of these interventions are different forms of psychodynamic therapy. Meta-analysis showed......Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy and psychodynamic therapy may be effective treatment options for major depressive disorder, but the effects have only had limited assessment in systematic...... reviews. The two modern forms of psychotherapy, "third wave" cognitive therapy and mentalization-based treatment, have both gained some ground as treatments of psychiatric disorders. No randomised trial has compared the effects of these two interventions for major depressive disorder. We performed two...

  19. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.

    Science.gov (United States)

    O'Cathain, Alicia; Thomas, Kate J; Drabble, Sarah J; Rudolph, Anne; Goode, Jackie; Hewison, Jenny

    2014-06-01

    Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. A sequential mixed methods study with four components. (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews

  20. TMI-2 core-examination program: INEL facilities readiness study

    International Nuclear Information System (INIS)

    McLaughlin, T.B.

    1983-02-01

    This report reviews the capability and readiness of remote handling facilities at the Idaho National Engineering Laboratory (INEL) to receive, and store the TMI-2 core, and to examine and analyze TMI-2 core samples. To accomplish these objectives, the facilities must be able to receive commercial casks, unload canisters from the casks, store the canisters, open the canisters, handle the fuel debris and assemblies, and perform various examinations. The report identifies documentation, including core information, necessary to INEL before receiving the entire TMI-2 core. Also identified are prerequisites to INEL's receipt of the first canister: costs, schedules, and a preliminary project plan for the tasks

  1. Examining Capacity and Functioning of Bicycle Coalitions: A Descriptive Study

    Directory of Open Access Journals (Sweden)

    Melissa Bopp

    2017-11-01

    Full Text Available BackgroundBicycle coalitions represent a strong partner in creating bike-friendly communities through advocacy for physical infrastructure, encouragement for biking, or education about safety. Despite their versatility, little is known about their functioning. Therefore, the purpose of this study was to examine capacity, strengths, and weaknesses of these organizations.MethodsBicycle coalitions/advocacy groups from English-speaking countries were recruited to take part in an online survey via email invitation. The survey addressed basic information about the coalition (community demographics, location, leadership, communication strategies, coalition priorities, barriers to programming/activities, and partners.ResultsCoalitions (n = 56 from four countries completed the survey. Most coalitions operated as a non-profit (n = 44, 95.7%, 45% (n = 21 have paid staff as leaders, while 37% (n = 17 have volunteers as leaders. The following skills were represented in coalitions’ leadership: fundraising (n = 31, 53.4%, event planning (n = 31, 53.4%, urban planning (n = 26, 44%, and policy/legislation expertise (n = 26, 44.8%. Education (n = 26, 63.4% and encouragement (n = 25, 61.6% were viewed as top priorities and the safety of bicyclists (n = 21, 46.7% and advocacy for infrastructure and policy (n = 22, 48.9% is the focus of most activities. A lack of financial resources (n = 36, 81.8% and capable personnel (n = 25, 56.8% were significant barriers to offering programming in the community and that the availability of grants to address issues (n = 38, 86.4% would be the top motivator for improvements.ConclusionBike coalitions represent a critical partner in creating activity-friendly environments and understanding their capacity allows for creating skill/capacity building intervention programs, development of effective toolkits and fostering strong collaborations to address physical inactivity.

  2. Diagnostic Examination for Students Entering Graduate Study in Soil Science.

    Science.gov (United States)

    Loynachan, T. E.

    1988-01-01

    Reports that students with soil science background performed better on a diagnostic examination; no relationship existed between exam performance and country of origin, degree sought, or undergraduate class quartile. Concludes that exam results, the grade received in a beginning graduate-level course and the cumulative graduate grade-point average…

  3. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an

  4. A trial studying approach to predict college achievement

    NARCIS (Netherlands)

    Meijer, Rob R.; Niessen, A. Susan M.

    2015-01-01

    We argue that using trial studying is a reliable and valid way to select students for higher education. This method is based on a work sample approach often used in personnel selection contexts. We discuss that this method has predictive validity for study success, has high acceptance by

  5. Study of skin markers for magnetic resonance imaging examinations

    International Nuclear Information System (INIS)

    Takatsu, Yasuo; Umezaki, Yoshie; Miyati, Tosiaki; Yamamura, Kenichirou

    2013-01-01

    In magnetic resonance imaging (MRI), skin markers are used as a landmark in order to make plans for examinations. However, there isn't a lot of research about the material and shape of skin markers. The skin marker's essential elements are safety, good cost performance, high signal intensity for T 1 weighted image (T 1 WI) and T 2 weighted image (T 2 WI), and durable. In order to get a high signal-to-noise ratio (SNR) of T 1 WI and T 2 WI, baby oil, salad oil and olive oil were chosen, because these materials were easy to obtain and safe for the skin. The SNR of baby oil was the best. Baby oil was injected into the infusion tube, and the tube was solvent welded and cut by a heat sealer. In order to make ring shaped skin markers, both ends of the tube were stuck with adhesive tape. Three different diameters of markers were made (3, 5, 10 cmφ). Ring shaped skin markers were put on to surround the examination area, therefore, the edge of the examination area could be seen at every cross section. Using baby oil in the ring shaped infusion tube is simple, easy, and a highly useful skin marker. (author)

  6. Oral Administration of Lactobacillus plantarum 299v Reduces Cortisol Levels in Human Saliva during Examination Induced Stress: A Randomized, Double-Blind Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hannah Andersson

    2016-01-01

    Full Text Available Objective. To clarify the effect of Lactobacillus plantarum 299v on the salivary cortisol and salivary IgA levels in young adults under examination stress. Design. Forty-one students with an upcoming academic exam were included in a randomized double-blind, placebo-controlled study. The probiotic bacteria or the placebo product was administered in capsules once a day during 14 days. Saliva was collected and a perceived stress test was filled out at each sampling occasion. Saliva was collected for cortisol analysis by Electrochemiluminescence Immunoassay (ECLI and salivary IgA was analysed by Enzyme-Linked Immunosorbent Assay (ELISA. Abundance of lactobacilli was evaluated by cultivation of saliva on selective medium and identification of L. plantarum 299v was done on randomly selected colonies by a random amplification of polymorphic DNA (RAPD typing. Results. A significant difference in cortisol levels was found between the treatment group and the placebo group (P<0.05, together with a significant increase in levels of lactobacilli in the treatment group compared with the placebo group (P<0.001. No significant changes were found for salivary IgA. Conclusion. A probiotic bacterium with ability to reduce symptoms of irritable bowel syndrome (IBS prohibited increased levels of the stress marker cortisol during the examination period. The registration number of the study is NCT02974894, and the study is registered at ClinicalTrials.gov.

  7. Leucine and ACE inhibitors as therapies for sarcopenia (LACE trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Band, Margaret M; Sumukadas, Deepa; Struthers, Allan D; Avenell, Alison; Donnan, Peter T; Kemp, Paul R; Smith, Karen T; Hume, Cheryl L; Hapca, Adrian; Witham, Miles D

    2018-01-04

    Sarcopenia (the age-related loss of muscle mass and function) is a major contributor to loss of mobility, falls, loss of independence, morbidity and mortality in older people. Although resistance training is effective in preventing and reversing sarcopenia, many older people are sedentary and either cannot or do not want to exercise. This trial examines the efficacy of supplementation with the amino acid leucine and/or angiotensin converting enzyme inhibition to potentially improve muscle mass and function in people with sarcopenia. Promising preliminary data exist from small studies for both interventions, but neither has yet been tested in adequately powered randomised trials in patients with sarcopenia. Leucine and ACE inhibitors in sarcopenia (LACE) is a multicentre, masked, placebo-controlled, 2 × 2 factorial randomised trial evaluating the efficacy of leucine and perindopril (angiotensin converting enzyme inhibitor (ACEi)) in patients with sarcopenia. The trial will recruit 440 patients from primary and secondary care services across the UK. Male and female patients aged 70 years and over with sarcopenia as defined by the European Working Group on Sarcopenia (based on low total skeletal muscle mass on bioimpedance analysis and either low gait speed or low handgrip strength) will be eligible for participation. Participants will be excluded if they have a contraindication to, or are already taking, an ACEi, angiotensin receptor blocker or leucine. The primary clinical outcome for the trial is the between-group difference in the Short Physical Performance Battery score at all points between baseline and 12 months. Secondary outcomes include appendicular muscle mass measured using dual-energy X-ray absorptiometry, muscle strength, activities of daily living, quality of life, activity using pedometer step counts and falls. Participants, clinical teams, outcomes assessors and trial analysts are masked to treatment allocation. A panel of biomarkers including

  8. The cessation in pregnancy incentives trial (CPIT): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Tappin, David M; Bauld, Linda; Tannahill, Carol; de Caestecker, Linda; Radley, Andrew; McConnachie, Alex; Boyd, Kathleen; Briggs, Andrew; Grant, Liz; Cameron, Alan; Macaskill, Susan; Sinclair, Lesley; Friel, Brenda; Coleman, Tim

    2012-07-20

    Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: 'How to stop smoking in pregnancy and following childbirth' (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy.Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can

  9. 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

  10. A randomized trial examining the effects of parent engagement on early language and literacy: the Getting Ready intervention.

    Science.gov (United States)

    Sheridan, Susan M; Knoche, Lisa L; Kupzyk, Kevin A; Edwards, Carolyn Pope; Marvin, Christine A

    2011-06-01

    Language and literacy skills established during early childhood are critical for later school success. Parental engagement with children has been linked to a number of adaptive characteristics in preschoolers including language and literacy development, and family-school collaboration is an important contributor to school readiness. This study reports the results of a randomized trial of a parent engagement intervention designed to facilitate school readiness among disadvantaged preschool children, with a particular focus on language and literacy development. Participants included 217 children, 211 parents, and 29 Head Start teachers in 21 schools. Statistically significant differences in favor of the treatment group were observed between treatment and control participants in the rate of change over 2 academic years on teacher reports of children's language use (d=1.11), reading (d=1.25), and writing skills (d=0.93). Significant intervention effects on children's direct measures of expressive language were identified for a subgroup of cases where there were concerns about a child's development upon entry into preschool. Additionally, other child and family moderators revealed specific variables that influenced the treatment's effects. Copyright © 2011 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

  11. The Move from Accuracy Studies to Randomized Trials in PET

    DEFF Research Database (Denmark)

    Siepe, Bettina; Hoilund-Carlsen, Poul Flemming; Gerke, Oke

    2014-01-01

    an important role in informing guideline developers and policy makers. Our aim was to investigate how far the nuclear medicine community has come on its way from accuracy studies to RCTs and which issues we have to take into account in planning future studies. METHODS: We conducted a systematic review...... of diagnostic randomized trials, in which PET was applied in only one arm. We covered published studies as well as registered unpublished and planned studies. We considered 3 quality indicators related to the usefulness of a trial to generate evidence for a clinical benefit: use of patient-important outcome......, sufficient sample size, and current standard as comparator. RESULTS: Fourteen published and 15 planned studies were identified. Five of the published studies and 12 of the planned studies did not use a patient-important outcome. Sample sizes were often so small that a significant result could be expected...

  12. Willingness to Study Abroad: An Examination of Kuwaiti Students

    Science.gov (United States)

    Hackney, Kaylee; Boggs, David; Kathawala, Yunus; Hayes, John

    2014-01-01

    International education is an increasingly important part of business programs throughout the world. This paper investigates the willingness of Kuwaiti business students to study abroad. It tests the hypotheses that student willingness to study abroad is related to a number of variables, including self-efficacy, perceived benefit of study abroad,…

  13. Failure of a systemic lupus erythematosus response index developed from clinical trial data: lessons examined and learned.

    Science.gov (United States)

    Forbess, L J; Bresee, C; Wallace, D J; Weisman, M H

    2017-08-01

    Background Our primary goal was to create an outcome change score index similar to a standard rheumatoid arthritis (RA) model utilizing real-world data in systemic lupus erythematosus (SLE) patients that occurred during their phase 3 trials with a Food and Drug Administration-approved drug. Methods We utilized raw data from trials of belimumab for the treatment of SLE. Data were split 80/20 into training/validation sets. Index variables present in a majority of patients and with face validity were selected. Variables were scored for each patient as percentage improvement from baseline after one year. The percentage of placebo- and drug-treated patients considered improved after the application of various criteria was ascertained. Logistic regression was employed to determine the ability of the new index to predict treatment assignment. Results A total of 1693 subjects had data for analyses. Eight variables were chosen: arthritis, rash, physician global assessment, fatigue, anti-double stranded DNA antibodies, C3, C4 and C-reactive protein. In the training dataset, ≥20% improvement in ≥4 of eight variables produced the largest difference between placebo- and drug-treated patients (22.1%) with an acceptable rate of improved placebo-treated patients (25%). This resulted in an odds ratio for belimumab (10 mg/kg) vs placebo of 2.7 (95% CI: 2.0-3.6; p < 0.001). However, in the validate dataset the odds ratio was not significant at 1.3 (95% CI: 0.8-2.2; p = 0.863). Conclusions The index created from training data did not achieve statistical significance when tested in the validation set. We have speculated why this happened. Is the lack of success of therapeutics for SLE caused by ineffective medications, study design and outcome instruments that fail to inform us, or is the heterogeneity of the disease too daunting? The lessons learned here can help direct future endeavors intended to improve SLE outcome instruments.

  14. A Randomized Trial Examining the Effects of Parent Engagement on Early Language and Literacy: The Getting Ready Intervention

    Science.gov (United States)

    Knoche, Lisa L.; Kupzyk, Kevin A.; Edwards, Carolyn Pope; Marvin, Christine A.

    2011-01-01

    Language and literacy skills established during early childhood are critical for later school success. Parental engagement with children has been linked to a number of adaptive characteristics in preschoolers including language and literacy development, and family-school collaboration is an important contributor to school readiness. This study reports the results of a randomized trial of a parent engagement intervention designed to facilitate school readiness among disadvantaged preschool children, with a particular focus on language and literacy development. Participants included 217 children, 211 parents, and 29 Head Start teachers in 21 schools. Statistically significant differences in favor of the treatment group were observed between treatment and control participants in the rate of change over 2 academic years on teacher reports of children’s language use (d = 1.11), reading (d = 1.25), and writing skills (d = .93). Significant intervention effects on children’s direct measures of expressive language were identified for a subgroup of cases where there were concerns about a child’s development upon entry into preschool. Additionally, other child and family moderators revealed specific variables that influenced the treatment’s effects. PMID:21640249

  15. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials

    DEFF Research Database (Denmark)

    Savović, Jelena; Jones, Hayley E; Altman, Douglas G

    2012-01-01

    bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes, with little evidence of bias in trials with objective and mortality outcomes. This study is limited by incomplete trial reporting, and findings may be confounded by other study design...

  16. The Healthy Steps Study: A randomized controlled trial of a pedometer-based Green Prescription for older adults. Trial protocol

    Directory of Open Access Journals (Sweden)

    Schluter Philip J

    2009-11-01

    Full Text Available Abstract Background Graded health benefits of physical activity have been demonstrated for the reduction of coronary heart disease, some cancers, and type-2 diabetes, and for injury reduction and improvements in mental health. Older adults are particularly at risk of physical inactivity, and would greatly benefit from successful targeted physical activity interventions. Methods/Design The Healthy Steps study is a 12-month randomized controlled trial comparing the efficacy of a pedometer-based Green Prescription with the conventional time-based Green Prescription in increasing and maintaining physical activity levels in low-active adults over 65 years of age. The Green Prescription interventions involve a primary care physical activity prescription with 3 follow-up telephone counselling sessions delivered by trained physical activity counsellors over 3 months. Those in the pedometer group received a pedometer and counselling based around increasing steps that can be monitored on the pedometer, while those in the standard Green Prescription group received counselling using time-based goals. Baseline, 3 month (end of intervention, and 12 month measures were assessed in face-to-face home visits with outcomes measures being physical activity (Auckland Heart Study Physical Activity Questionnaire, quality of life (SF-36 and EQ-5D, depressive symptoms (Geriatric Depression Scale, blood pressure, weight status, functional status (gait speed, chair stands, and tandem balance test and falls and adverse events (self-report. Utilisation of health services was assessed for the economic evaluation carried out alongside this trial. As well, a process evaluation of the interventions and an examination of barriers and motives for physical activity in the sample were conducted. The perceptions of primary care physicians in relation to delivering physical activity counselling were also assessed. Discussion The findings from the Healthy Steps trial are due in late

  17. A PROSPECTIVE RANDOMISED STUDY OF THE EFFECT OF DILTIAZEM IN THE DRE AND PROCTOSCOPIC EXAMINATION

    Directory of Open Access Journals (Sweden)

    R. C. Thampan

    2018-01-01

    Full Text Available BACKGROUND Digital Rectal Examination (DRE and proctoscopy is an important routine investigation done by surgeons, gastroenterologists’, etc. Most of the patients complain of pain and discomfort during the procedure. Anal sphincter complex contracts to the penetrating index finger as a voluntary reflex try to avoid hurting. A good lubricant jelly (with 2% lignocaine and extreme gentleness should be the rule to this procedure to avoid discomfort and pain to the patients. Even with maximum precautions, majority of patients complain discomfort or pain during the procedure. To overcome this problem, we tried lubricant jelly and diltiazem gel combination. MATERIALS AND METHODS We evaluated 500 patients in this trial during the period 2010 to 2015 from the OPD of our institution with lubricant jelly alone and with diltiazem in the interval of two weeks. Analysis showed most of the patients is comfortable with combination lubricant jelly and diltiazem gel rather than lubricant jelly alone. RESULTS A total of 625 patients were screened for this study, but only 560 considered and enrolled (mean age 40 years. 60 patients failed to attend for the second examination, hence they were excluded from the final analysis. CONCLUSION The importance of DRE and proctoscopy known to every clinician, since it provides valuable information about anorectal pathology. Some patients are reluctant to give consent thinking that it will hurt them. By mixing lubricant jelly with diltiazem, the procedure becomes really comfortable due to good relaxation of anal sphincter complex.

  18. Examining the etiology of childhood obesity: The IDEA study.

    Science.gov (United States)

    Lytle, Leslie A

    2009-12-01

    The prevalence of childhood obesity is of great public health concern. A social ecological framework that is transdisciplinary and multilevel by nature is recognized as the most promising approach for studying this problem. The purpose of this paper is to describe longitudinal research using a social ecological framework to study the etiology of childhood obesity. Individual and contextual factors are assessed in a cohort of youth and their parents including psychosocial factors, and home, school and neighborhood environments. The conceptual model guiding the research and the study design and measures used to operationalize the factors in the model and the descriptive characteristics of the baseline sample of youth and parents enrolled in the research are presented. The use of a conceptual model to guide the research, a transdisciplinary approach, a longitudinal cohort design and state-of-the-art measures of the individual and the environment are strengths of this research.

  19. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  20. Comparison of study designs for acute otitis media trials.

    Science.gov (United States)

    Pichichero, Michael E; Casey, Janet R

    2008-06-01

    A framework for evaluating the efficacy of antibiotics in development as well as those currently approved for acute otitis media (AOM) is needed. Review strengths and limitations of various antibiotic trial designs and their outcome measures. A review of 157 published trials involving 36,710 subjects for the treatment of AOM. AOM trials have three designs: (1) clinical, clinical diagnosis and assessment of outcomes; (2) single tympanocentesis, microbiologic diagnosis (by middle ear fluid culture) and clinical assessment of outcomes; and (3) double tympanocentesis, microbiologic diagnosis and microbiologic outcome assessment. Identifiable strengths and limitations of each design are reviewed. Case definitions for entry of children in trials of AOM vary widely. The lack of stringent diagnostic criteria in a clinical design allows for inclusion of a significant proportion of children with a non-bacterial etiology (i.e., viral AOM or otitis media with effusion). Tympanocentesis increases diagnostic accuracy at study entry; however, the procedure is confounding because of its potentially therapeutic benefit and the procedure is not performed in a uniform manner. A second tympanocentesis allows a high sensitivity to detect microbiologic eradication, but it does not correlate with clinical outcomes in half of the cases. The timing of outcome assessment also varies widely among trials. Improved clinical diagnosis criteria for AOM are needed to enhance specificity; emphasis on a bulging tympanic membrane has the best evidence base. Tympanocentesis within study designs has merits. At study entry it assures diagnostic accuracy but may alter outcomes and it is useful to document microbiologic outcomes but lacks specificity for clinical outcomes. For all designs, test of cure assessment 2-7 days after completion of therapy seems most appropriate.

  1. A contemporary examination of workplace learning culture: an ethnomethodology study.

    Science.gov (United States)

    Newton, Jennifer M; Henderson, Amanda; Jolly, Brian; Greaves, Judith

    2015-01-01

    Creating and maintaining a sustainable workforce is currently an international concern. Extensive literature suggest that students and staff need to be 'engaged', that is they need to interact with the health team if they are to maximise learning opportunities. Despite many studies since the 1970s into what creates a 'good' learning environment, ongoing issues continue to challenge healthcare organisations and educators. A 'good' learning environment has been an intangible element for many professions as learning is hindered by the complexity of practice and by limitations on practitioners' time available to assist and guide novices. This study sought to explore the nature of the learning interactions and experiences in clinical nursing practice that enhance a 'good' workplace learning culture for both nursing students and qualified nurses. An ethnomethodology study. A range of clinical settings in Victoria and Queensland, Australia. Students and registered nurses (n=95). Fieldwork observations were carried out on student nurses and registered nurses, followed by an individual interview with each participant. An iterative approach to analysis was undertaken; field notes of observations were reviewed, interviews transcribed verbatim and entered into NVivo10. Major themes were then extracted. Three central themes: learning by doing, navigating through communication, and 'entrustability', emerged providing insights into common practices potentially enhancing or detracting from learning in the workplace. Students' and registered nurses' learning is constrained by a myriad of interactions and embedded workplace practices, which can either enhance the individual's opportunities for learning or detract from the richness of affordances that healthcare workplace settings have to offer. Until the culture/or routine practices of the healthcare workplace are challenged, the trust and meaningful communication essential to learning in practice, will be achievable only

  2. Study Addiction: A Cross-Cultural Longitudinal Study Examining Temporal Stability and Predictors of Its Changes

    OpenAIRE

    Atroszko, Pawe? Andrzej; Andreassen, Cecilie Schou; Griffiths, Mark D.; Pallesen, St?le

    2016-01-01

    Background and aims: "Study addiction" has recently been conceptualized as a behavioral addiction and defined within the framework of work addiction. Using a newly developed measure to assess this construct, the Bergen Study Addiction Scale (BStAS), the present study examined the 1-year stability of study addiction and factors related to changes in this construct over time, and is the first longitudinal investigation of study addiction thus far. \\ud Methods: The BStAS and the Ten Item Persona...

  3. Subgroup Analysis of Trials Is Rarely Easy (SATIRE): a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials.

    Science.gov (United States)

    Sun, Xin; Briel, Matthias; Busse, Jason W; Akl, Elie A; You, John J; Mejza, Filip; Bala, Malgorzata; Diaz-Granados, Natalia; Bassler, Dirk; Mertz, Dominik; Srinathan, Sadeesh K; Vandvik, Per Olav; Malaga, German; Alshurafa, Mohamed; Dahm, Philipp; Alonso-Coello, Pablo; Heels-Ansdell, Diane M; Bhatnagar, Neera; Johnston, Bradley C; Wang, Li; Walter, Stephen D; Altman, Douglas G; Guyatt, Gordon H

    2009-11-09

    Subgroup analyses in randomized trials examine whether effects of interventions differ between subgroups of study populations according to characteristics of patients or interventions. However, findings from subgroup analyses may be misleading, potentially resulting in suboptimal clinical and health decision making. Few studies have investigated the reporting and conduct of subgroup analyses and a number of important questions remain unanswered. The objectives of this study are: 1) to describe the reporting of subgroup analyses and claims of subgroup effects in randomized controlled trials, 2) to assess study characteristics associated with reporting of subgroup analyses and with claims of subgroup effects, and 3) to examine the analysis, and interpretation of subgroup effects for each study's primary outcome. We will conduct a systematic review of 464 randomized controlled human trials published in 2007 in the 118 Core Clinical Journals defined by the National Library of Medicine. We will randomly select journal articles, stratified in a 1:1 ratio by higher impact versus lower impact journals. According to 2007 ISI total citations, we consider the New England Journal of Medicine, JAMA, Lancet, Annals of Internal Medicine, and BMJ as higher impact journals. Teams of two reviewers will independently screen full texts of reports for eligibility, and abstract data, using standardized, pilot-tested extraction forms. We will conduct univariable and multivariable logistic regression analyses to examine the association of pre-specified study characteristics with reporting of subgroup analyses and with claims of subgroup effects for the primary and any other outcomes. A clear understanding of subgroup analyses, as currently conducted and reported in published randomized controlled trials, will reveal both strengths and weaknesses of this practice. Our findings will contribute to a set of recommendations to optimize the conduct and reporting of subgroup analyses, and claim

  4. Subgroup Analysis of Trials Is Rarely Easy (SATIRE: a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials

    Directory of Open Access Journals (Sweden)

    Malaga German

    2009-11-01

    Full Text Available Abstract Background Subgroup analyses in randomized trials examine whether effects of interventions differ between subgroups of study populations according to characteristics of patients or interventions. However, findings from subgroup analyses may be misleading, potentially resulting in suboptimal clinical and health decision making. Few studies have investigated the reporting and conduct of subgroup analyses and a number of important questions remain unanswered. The objectives of this study are: 1 to describe the reporting of subgroup analyses and claims of subgroup effects in randomized controlled trials, 2 to assess study characteristics associated with reporting of subgroup analyses and with claims of subgroup effects, and 3 to examine the analysis, and interpretation of subgroup effects for each study's primary outcome. Methods We will conduct a systematic review of 464 randomized controlled human trials published in 2007 in the 118 Core Clinical Journals defined by the National Library of Medicine. We will randomly select journal articles, stratified in a 1:1 ratio by higher impact versus lower impact journals. According to 2007 ISI total citations, we consider the New England Journal of Medicine, JAMA, Lancet, Annals of Internal Medicine, and BMJ as higher impact journals. Teams of two reviewers will independently screen full texts of reports for eligibility, and abstract data, using standardized, pilot-tested extraction forms. We will conduct univariable and multivariable logistic regression analyses to examine the association of pre-specified study characteristics with reporting of subgroup analyses and with claims of subgroup effects for the primary and any other outcomes. Discussion A clear understanding of subgroup analyses, as currently conducted and reported in published randomized controlled trials, will reveal both strengths and weaknesses of this practice. Our findings will contribute to a set of recommendations to optimize

  5. Examining Road Traffic Mortality Status in China: A Simulation Study.

    Science.gov (United States)

    Huang, Helai; Yin, Qingyi; Schwebel, David C; Li, Li; Hu, Guoqing

    2016-01-01

    Data from the Chinese police service suggest substantial reductions in road traffic injuries since 2002, but critics have questioned the accuracy of those data, especially considering conflicting data reported by the health department. To address the gap between police and health department data and to determine which may be more accurate, we conducted a simulation study based on the modified Smeed equation, which delineates a non-linear relation between road traffic mortality and the level of motorization in a country or region. Our goal was to simulate trends in road traffic mortality in China and compare performances in road traffic safety management between China and 13 other countries. Chinese police data indicate a peak in road traffic mortalities in 2002 and a significant and a gradual decrease in population-based road traffic mortality since 2002. Health department data show the road traffic mortality peaked in 2012. In addition, police data suggest China's road traffic mortality peaked at a much lower motorization level (0.061 motor vehicles per person) in 2002, followed by a reduction in mortality to a level comparable to that of developed countries. Simulation results based on health department data suggest high road traffic mortality, with a mortality peak in 2012 at a moderate motorization level (0.174 motor vehicles per person). Comparisons to the other 13 countries suggest the health data from China may be more valid than the police data. Our simulation data indicate China is still at a stage of high road traffic mortality, as suggested by health data, rather than a stage of low road traffic mortality, as suggested by police data. More efforts are needed to integrate safety into road design, improve road traffic management, improve data quality, and alter unsafe behaviors of pedestrians, drivers and passengers in China.

  6. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Graeme B

    2012-09-01

    delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability. Discussion The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention. Trial Registration Current Controlled Trials ISRCTN43218782

  7. Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial.

    Science.gov (United States)

    Hackshaw-McGeagh, Lucy; Lane, J Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M; Martin, Richard

    2016-03-07

    A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy to interventions that modify nutrition and physical activity. The primary outcomes are randomisation rates and adherence to the interventions at 6 months following randomisation. The secondary outcomes are intervention tolerability, trial retention, change in prostate specific antigen level, change in diet, change in general physical activity levels, insulin-like growth factor levels, and a range of related outcomes, including quality of life measures. The trial is factorial, randomising men to both a physical activity (brisk walking or control) and nutritional (lycopene supplementation or increased fruit and vegetables with reduced dairy consumption or control) intervention. The trial has two phases: men are enrolled into a cohort study prior to radical prostatectomy, and then consented after radical prostatectomy into a randomised controlled trial. Data are collected at four time points (cohort baseline, true trial baseline and 3 and 6 months post-randomisation). The Prostate Cancer: Evidence of Exercise and Nutrition Trial aims to determine whether men with localised prostate cancer who are scheduled for radical prostatectomy can be recruited into a cohort and subsequently randomised to a 6-month nutrition and physical activity intervention trial. If successful, this feasibility trial will inform a larger trial to investigate whether this population will gain clinical benefit from long-term nutritional and physical activity

  8. Visual mismatch and predictive coding: A computational single-trial ERP study.

    Science.gov (United States)

    Stefanics, Gabor; Heinzle, Jakob; Attila Horváth, András; Enno Stephan, Klaas

    2018-03-26

    Predictive coding (PC) posits that the brain employs a generative model to infer the environmental causes of its sensory data and uses precision-weighted prediction errors (pwPE) to continuously update this model. While supported by much circumstantial evidence, experimental tests grounded in formal trial-by-trial predictions are rare. One partial exception are event-related potential (ERP) studies of the auditory mismatch negativity (MMN), where computational models have found signatures of pwPEs and related model-updating processes.Here, we tested this hypothesis in the visual domain, examining possible links between visual mismatch responses and pwPEs. We used a novel visual 'roving standard' paradigm to elicit mismatch responses in humans (of both sexes) by unexpected changes in either color or emotional expression of faces. Using a hierarchical Bayesian model, we simulated pwPE trajectories of a Bayes-optimal observer and used these to conduct a comprehensive trial-by-trial analysis across the time×sensor space. We found significant modulation of brain activity by both color and emotion pwPEs. The scalp distribution and timing of these single-trial pwPE responses were in agreement with visual mismatch responses obtained by traditional averaging and subtraction (deviant-minus-standard) approaches. Finally, we compared the Bayesian model to a more classical change detection (CD) model of MMN. Model comparison revealed that trial-wise pwPEs explained the observed mismatch responses better than categorical change detection.Our results suggest that visual mismatch responses reflect trial-wise pwPEs, as postulated by PC. These findings go beyond classical ERP analyses of visual mismatch and illustrate the utility of computational analyses for studying automatic perceptual processes. SIGNIFICANCE STATEMENT Human perception is thought to rely on a predictive model of the environment which is updated via precision-weighted prediction errors (pwPE) when events violate

  9. Clinical Trials

    Medline Plus

    Full Text Available ... study results. Clinical 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 is led by a principal investigator ( ...

  10. The MATISSE study: a randomised trial of group art therapy for people with schizophrenia.

    Science.gov (United States)

    Crawford, Mike J; Killaspy, Helen; Kalaitzaki, Eleftheria; Barrett, Barbara; Byford, Sarah; Patterson, Sue; Soteriou, Tony; O'Neill, Francis A; Clayton, Katie; Maratos, Anna; Barnes, Thomas R; Osborn, David; Johnson, Tony; King, Michael; Tyrer, Peter; Waller, Diana

    2010-08-27

    Art Therapy has been promoted as a means of helping people who may find it difficult to express themselves verbally engage in psychological treatment. Group Art Therapy has been widely used as an adjunctive treatment for people with schizophrenia but there have been few attempts to examine its effects and cost effectiveness has not been examined. The MATISSE study aims to evaluate the clinical and cost effectiveness of group Art Therapy for people with schizophrenia. The MATISSE study is a three-arm, parallel group, pragmatic, randomised, controlled trial of referral to group Art Therapy plus standard care, referral to an attention control 'activity' group plus standard care, or standard care alone. Study participants were recruited from inpatient and community-based mental health and social care services at four centres in England and Northern Ireland. Participants were aged over 18 years with a clinical diagnosis of schizophrenia, confirmed by an examination of case notes using operationalised criteria. Participants were then randomised via an independent and remote telephone randomisation service using permuted stacked blocks, stratified by site. Art Therapy and activity groups were made available to participants once a week for up to 12 months. Outcome measures were assessed by researchers masked to allocation status at 12 and 24 months after randomisation. Participants and care givers were aware which arm of the trial participants were allocated to. The primary outcomes for the study are global functioning (measured using the Global Assessment of Functioning scale) and mental health symptoms (measured using the Positive and Negative Syndrome Scale) assessed at 24 months. Secondary outcomes were assessed at 12 and 24 months and comprise levels of group attendance, social function, satisfaction with care, mental wellbeing, and costs. We believe that this is the first large scale pragmatic trial of Art Therapy for people with schizophrenia. Current Controlled

  11. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

    Science.gov (United States)

    Scott, Amelia; Rucklidge, Julia J; Mulder, Roger T

    2015-01-01

    To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding. Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type. Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant numbers of 20% or more; only 26 (14.4%) of

  12. Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Henaux, Pierre-Louis; Le Reste, Pierre-Jean; Laviolle, Bruno; Morandi, Xavier

    2017-06-05

    Chronic subdural hematoma (CSDH) is a common neurological pathology, especially in older patients. The actual "gold standard" of treatment is surgical evacuation, with various techniques used across neurosurgical teams. Over the years, there has been growing evidence that inflammatory processes play a major role in the pathogenesis of CSDH. In that context, the use of corticosteroids has been proposed alone or as an adjuvant treatment to surgery. However, this practice remains very empirical and there is a need for high-quality-of-evidence studies to clarify the role of corticosteroids in the management of CSDH. We propose a double-blind, randomized controlled trial comparing methylprednisolone versus placebo in the treatment of CSDH without clinical and/or radiological signs of severity. The treatment will be administered daily for a duration of 3 weeks, at a dose of 1 mg/kg. The primary endpoint will be the delay of occurrence of surgical treatment at 1 month following the introduction of the treatment. Secondary endpoints will include the rate of recourse to surgery, survival rate, quality of life and functional assessments, occurrence of systemic secondary effects and radiological assessment of the response to treatment. This multimodal assessment will be done at 1, 3 and 6 months. Two hundred and two patients (101 per arm) are expected to be included considering our primary hypotheses. This trial started in June 2016; its results may open interesting alternatives to surgery in the management of patients harboring a CSDH, and may provide insights into the natural history of this common pathology. ClinicalTrials.gov, ID: NCT02650609 . Registered on 4 January 2016. Graphical output of the OBF boundaries.

  13. The healthy steps study: a randomized controlled trial of a pedometer-based green prescription for older adults. Trial protocol.

    Science.gov (United States)

    Kolt, Gregory S; Schofield, Grant M; Kerse, Ngaire; Garrett, Nicholas; Schluter, Philip J; Ashton, Toni; Patel, Asmita

    2009-11-01

    Graded health benefits of physical activity have been demonstrated for the reduction of coronary heart disease, some cancers, and type-2 diabetes, and for injury reduction and improvements in mental health. Older adults are particularly at risk of physical inactivity, and would greatly benefit from successful targeted physical activity interventions. The Healthy Steps study is a 12-month randomized controlled trial comparing the efficacy of a pedometer-based Green Prescription with the conventional time-based Green Prescription in increasing and maintaining physical activity levels in low-active adults over 65 years of age. The Green Prescription interventions involve a primary care physical activity prescription with 3 follow-up telephone counselling sessions delivered by trained physical activity counsellors over 3 months. Those in the pedometer group received a pedometer and counselling based around increasing steps that can be monitored on the pedometer, while those in the standard Green Prescription group received counselling using time-based goals. Baseline, 3 month (end of intervention), and 12 month measures were assessed in face-to-face home visits with outcomes measures being physical activity (Auckland Heart Study Physical Activity Questionnaire), quality of life (SF-36 and EQ-5D), depressive symptoms (Geriatric Depression Scale), blood pressure, weight status, functional status (gait speed, chair stands, and tandem balance test) and falls and adverse events (self-report). Utilisation of health services was assessed for the economic evaluation carried out alongside this trial. As well, a process evaluation of the interventions and an examination of barriers and motives for physical activity in the sample were conducted. The perceptions of primary care physicians in relation to delivering physical activity counselling were also assessed. The findings from the Healthy Steps trial are due in late 2009. If successful in improving physical activity in older

  14. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce F

    2011-10-01

    Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial

  15. Are potentially clinically meaningful benefits misinterpreted in cardiovascular randomized trials? A systematic examination of statistical significance, clinical significance, and authors' conclusions.

    Science.gov (United States)

    Allan, G Michael; Finley, Caitlin R; McCormack, James; Kumar, Vivek; Kwong, Simon; Braschi, Emelie; Korownyk, Christina; Kolber, Michael R; Lindblad, Adriennne J; Babenko, Oksana; Garrison, Scott

    2017-03-20

    While journals and reporting guidelines recommend the presentation of confidence intervals, many authors adhere strictly to statistically significant testing. Our objective was to determine what proportions of not statistically significant (NSS) cardiovascular trials include potentially clinically meaningful effects in primary outcomes and if these are associated with authors' conclusions. Cardiovascular studies published in six high-impact journals between 1 January 2010 and 31 December 2014 were identified via PubMed. Two independent reviewers selected trials with major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death) as primary outcomes and extracted data on trial characteristics, quality, and primary outcome. Potentially clinically meaningful effects were defined broadly as a relative risk point estimate ≤0.94 (based on the effects of ezetimibe) and/or a lower confidence interval ≤0.75 (based on the effects of statins). We identified 127 randomized trial comparisons from 3200 articles. The primary outcomes were statistically significant (SS) favoring treatment in 21% (27/127), NSS in 72% (92/127), and SS favoring control in 6% (8/127). In 61% of NSS trials (56/92), the point estimate and/or lower confidence interval included potentially meaningful effects. Both point estimate and confidence interval included potentially meaningful effects in 67% of trials (12/18) in which authors' concluded that treatment was superior, in 28% (16/58) with a neutral conclusion, and in 6% (1/16) in which authors' concluded that control was superior. In a sensitivity analysis, 26% of NSS trials would include potential meaningful effects with relative risk thresholds of point estimate ≤0.85 and/or a lower confidence interval ≤0.65. Point estimates and/or confidence intervals included potentially clinically meaningful effects in up to 61% of NSS cardiovascular trials. Authors' conclusions often reflect potentially meaningful results of

  16. Randomised controlled trial examining the effect of exercise in people with rheumatoid arthritis taking anti-TNFα therapy medication.

    LENUS (Irish Health Repository)

    Reid, Angela

    2011-01-01

    Substantial progress has been made in the medical management of rheumatoid arthritis (RA) over the past decade with the introduction of biologic therapies, including anti-tumour necrosis factor alpha (anti-TNFα) therapy medications. However, individuals with RA taking anti-TNFα medication continue to experience physical, psychological and functional consequences, which could potentially benefit from rehabilitation. There is evidence that therapeutic exercise should be included as an intervention for people with RA, but to date there is little evidence of the benefits of therapeutic exercise for people with RA on anti-TNFα therapy medication. A protocol for a multicentre randomised controlled three-armed study which aims to examine the effect of dynamic group exercise therapy on land or in water for people with RA taking anti-TNFα therapy medication is described.

  17. A randomized phase II dose-response exercise trial among colon cancer survivors: Purpose, study design, methods, and recruitment results.

    Science.gov (United States)

    Brown, Justin C; Troxel, Andrea B; Ky, Bonnie; Damjanov, Nevena; Zemel, Babette S; Rickels, Michael R; Rhim, Andrew D; Rustgi, Anil K; Courneya, Kerry S; Schmitz, Kathryn H

    2016-03-01

    Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the courage trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. The primary objective of the courage trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·week(-1)) and high-dose (300 min·week(-1)) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (Pclinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care).

    Science.gov (United States)

    Cavender, Matthew A; White, William B; Jarolim, Petr; Bakris, George L; Cushman, William C; Kupfer, Stuart; Gao, Qi; Mehta, Cyrus R; Zannad, Faiez; Cannon, Christopher P; Morrow, David A

    2017-05-16

    We aimed to describe the relationship between changes in high-sensitivity cardiac troponin I (hsTnI) and cardiovascular outcomes. The EXAMINE trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care) was a phase IIIb clinical outcomes trial designed to evaluate the cardiovascular safety of alogliptin, a nonselective dipeptidyl peptidase 4 inhibitor. Patients with type 2 diabetes mellitus, glycohemoglobin between 6.5% and 11% (or between 7% and 11% if they were on insulin), and a recent acute coronary syndrome (between 15 and 90 days before randomization) were eligible for the trial. hsTnI was measured using the Abbott ARCHITECT assay at baseline and 6 months in patients randomized in the EXAMINE trial. This analysis was restricted to patients randomized ≥30 days after qualifying acute coronary syndrome to mitigate the potential for persistent hsTnI elevation after acute coronary syndrome (n=3808). The primary end point of the trial was cardiovascular death, myocardial infarction, or stroke. Cardiovascular death or heart failure was a prespecified, adjudicated secondary end point. At baseline, hsTnI was detectable (≥1.9 ng/L) in 93% of patients and >99 th percentile upper reference limit in 16%. There was a strong relationship between increasing hsTnI, both at baseline and 6 months, and the incidence of cardiovascular events through 24 months ( P 28.1% versus 8.8%; adjusted hazard ratio, 2.65; 95% confidence interval, 1.64-4.28; P 22.5% versus 8.8%; adjusted hazard ratio, 1.90; 95% confidence interval, 1.33-2.70; P 22.3% versus 23.0%; hazard ratio, 0.87; 95% confidence interval, 0.60-1.25; P =0.44). Serial assessment of hsTnI revealed a substantial proportion of patients with type 2 diabetes mellitus without clinically recognized events had dynamic or persistently elevated values and were at high risk of recurrent events. hsTnI may have a role in personalizing preventive strategies in patients with diabetes mellitus based on risk

  19. Frailty measurement and outcomes in interventional studies: protocol for a systematic review of randomised control trials.

    Science.gov (United States)

    Shears, Melissa; McGolrick, Danielle; Waters, Braden; Jakab, Marnie; Boyd, J Gordon; Muscedere, John

    2017-12-26

    Frailty is associated with reduced functional capacity, decreased resistance to stressors and is predictive of a range of adverse health outcomes, including dependency, hospitalisation and mortality. Early identification of frailty may prevent, reduce and postpone adverse health outcomes. However, there is a need for additional evidence to guide decision-making for the care of frail patients since frail persons are frequently excluded from studies, the differential impact of frailty is often not examined in clinical trials and few large-scale clinical trials examining frail cohorts have been conducted. Randomised control trials (RCTs) published to date have used a diverse range of definitions of frailty, as well as a variety of outcome measures. The objective of this systematic review is to comprehensively characterise the frail populations enrolled and the end points reported in frailty RCTs. We will identify all RCTs reporting on the outcome of interventions in adult (age ≥18 years) frail populations as defined by authors, in all settings of care. Databases will include MEDLINE, CINAHL, EMBASE, PsycInfo, Global Health, the Joanna Briggs database and Cochrane Library. Two reviewers will independently determine trial eligibility. For each included trial, we will conduct duplicate independent data extraction, inter-rater reliability, risk of bias assessment and evaluation of the quality of the evidence using the Grading of Recommendations, Assessment, Development and Evaluations approach. This systematic review will comprehensively identify RCTs including frail patients to identify how frailty is measured and which outcomes are reported. The results of this systematic review may inform clinicians caring for persons with frailty, facilitate conduct of future RCTs and inform future efforts to develop common data elements and core outcomes for frailty studies. Our findings will be disseminated through conference presentation and publication in peer-reviewed journals

  20. An action research study on the effect of an examination preparation course on Veterinary Technology National Examination scores

    Science.gov (United States)

    Limon, Jennifer S.

    The action research project used for this dissertation was intended to examine the effect of implementing an examination preparation course for graduates taking the Veterinary Technology National Examination in Louisiana. Previous data showed that scores on the VTNE were declining at not only the state, but also the national level, thus allowing less graduates to enter the workforce as Registered Veterinary Technicians in Louisiana. The research question was "What impact did the exam prep course have on VTNE test scores?" The researcher focused on helping to better prepare graduates from a local community college Veterinary Technology program to take the VTNE by implementing an exam review course in the semester prior to graduation from the program. The focus of the review course was not only content review, but also test taking techniques, help with study habits, as well as presentation of techniques to help deal with test anxiety. Three sources of data were collected by the researcher including pre and post intervention VTNE scores, as well as survey results completed by the graduates participating in the study. There were 13 graduates who participated in the study, and the data for 50 prior graduates was used as a comparison for score improvement. Upon completion of the intervention, Analysis of Variance (ANOVA) tests were used to analyze the data. The results revealed that while the intervention did have a positive effect on the graduates in terms of feeling prepared for the exam, it did not improve VTNE scores. A survey was administered to the participants upon completion of the course, and thematic coding was used to analyze the qualitative data. Overall the results indicated the learners felt the course helped prepare them for the VTNE, and the majority recommended implementing it for future learners.

  1. Study design issues in trials among children with MAM

    International Nuclear Information System (INIS)

    Friis, Henrik

    2014-01-01

    There is a need for acceptable and affordable food aid products for children with moderate acute malnutrition (MAM), which effectively restore body tissues and functions. The effects of potential products need to be assessed through randomised controlled trials (RCT). However, nutritional RCTs pose ethical and scientific challenges. Control groups are usually given “standard of care”, but recommendations for treatment do not exist in all settings or supplements are not always available. In places where treatment is nonexistent, not giving any food to children in the control group is not without ethical concerns. However, from public health and scientific perspectives, it is problematic to compare with supplements which are not recommended or the effect of which is unknown. Firstly, it is of questionable value for a low-income country that a trial is conducted to compare an experimental supplement to a supplement that is not already standard of care, and national ethics committees may not grant permission for such a trial. Secondly, it is difficult to interpret findings from a trial comparing an experimental supplement to one that has not been properly tested. Hence, where supplementation is not standard of care, it may be ethically justifiable to have an unsupplemented control group. In such cases, mothers should receive health education and the children should receive medical attention, be monitored closely, and referred for further medical examination and treatment if not recovering. Delayed supplementation may also be considered. Food interventions are complex, since supplements with the same energy content may be based on different ingredients, and nutrients in different forms and amounts. Consequently, there are an infinite number of potential food supplements, yet only a few can be tested in trials. Some components may be potentially important, but costly. If several factors are of interest, then a factorial design may be needed. E.g. the treatFOOD trial

  2. A triple-blinded, randomized, placebo-controlled trial to examine the efficacy of buspirone added to typical antipsychotic drugs in patients with chronic schizophrenia

    Directory of Open Access Journals (Sweden)

    Fatemeh Sheikhmoonesi

    2015-01-01

    Full Text Available Background: The purpose of this study was to test the hypothesis that the addition of buspirone, a partial agonist of 5HT1A receptor, to ongoing treatment with typical antipsychotics would improve the positive and negative symptoms in patients with chronic schizophrenia. Materials and Methods: In this study, 50 patients including 40 male and 10 female were recruited with chronic schizophrenia who were inpatients at psychiatric teaching hospital or asylums, aged between 18 and 65 years (mean age = 47 ± 10.02. All patients were on the stable dose of typical antipsychotics for at least 1-month, and their acute symptoms were controlled. Patients were allocated in a random fashion: 25 patients to buspirone at 30 mg/day plus typical antipsychotic and 25 patients to placebo plus typical antipsychotic. The positive and negative syndrome scale (PANSS, Simpson-Angus extrapyramidal rating scale (SAS and mini mental state examination (MMSE, were administered at baseline, and 2, 4, and 6 weeks after the addition of buspirone. Results: The 30 mg/day buspirone was well-tolerated, and no clinically important adverse effects were seen. There was no statistically significant difference between the two groups in MMSE and SAS scales. There was a significant reduction in subscales of negative, general, positive, and total of PANSS over the 6-week trial in buspirone group. There was a statistically significant difference between the two groups negative subscale (mean ± standard deviation [SD] = 14.08 ± 1.4 in buspirone group P = 0.0219, general subscale (mean ± SD = 27.42 ± 2.1 in buspirone group P = 0.0004, and total subscale (mean ± SD = 55.63 ± 3.9 in buspirone group P = 0.0298, of PANSS in the 6-week of trial. Conclusion: The results suggest that adjunctive treatment with 5HT1A agonist such as buspirone may improve the negative symptoms of schizophrenia. Further studies are indicated to determine the efficacy of 5HT1A agonist treatment in chronic

  3. Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major depressive disorder.

    Science.gov (United States)

    Jakobsen, Janus Christian

    2014-10-01

    Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy and psychodynamic therapy may be effective treatment options for major depressive disorder, but the effects have only had limited assessment in systematic reviews. The two modern forms of psychotherapy, "third wave" cognitive therapy and mentalization-based treatment, have both gained some ground as treatments of psychiatric disorders. No randomised trial has compared the effects of these two interventions for major depressive disorder. We performed two systematic reviews with meta-analyses and trial sequential analyses using The Cochrane Collaboration methodology examining the effects of cognitive therapy and psycho-dynamic therapy for major depressive disorder. We developed a thorough treatment protocol for a randomised trial with low risks of bias (systematic error) and low risks of random errors ("play of chance") examining the effects of third wave' cognitive therapy versus mentalization-based treatment for major depressive disorder. We conducted a randomised trial according to good clinical practice examining the effects of "third wave" cognitive therapy versus mentalisation-based treatment for major depressive disorder. The first systematic review included five randomised trials examining the effects of psychodynamic therapy versus "no intervention' for major depressive disorder. Altogether the five trials randomised 365 participants who in each trial received similar antidepressants as co-interventions. All trials had high risk of bias. Four trials assessed "interpersonal psychotherapy" and one trial "short psychodynamic supportive psychotherapy". Both of these interventions are different forms of psychodynamic therapy. Meta-analysis showed that psychodynamic therapy significantly reduced depressive symptoms on the Hamilton Depression Rating Scale (HDRS) compared with "no intervention" (mean difference -3.01 (95

  4. Post-study aspirin intake and factors motivating participation in a colorectal cancer chemoprevention trial.

    Science.gov (United States)

    Sample, Dory A; Sinicrope, Pamela S; Wargovich, Michael J; Sinicrope, Frank A

    2002-03-01

    We conducted an exploratory, cross-sectional study examining motivators for study participation and post-study aspirin intake in a chemoprevention trial. The parent clinical trial aimed to determine the optimal aspirin dose for colorectal cancer chemoprevention using prostaglandin E(2) as a mucosal biomarker. This trial was randomized and double-blinded in 60 subjects with prior sporadic colorectal adenoma(s) and evaluated three aspirin doses or placebo taken once daily for 4 weeks. A cross-section of 55 evaluable participants who completed the chemoprevention trial were mailed a 16-item, self-administered questionnaire evaluating subject demographics, motivational factors, and health-related behaviors within the framework of Pender's Health Promotion Model (HPM). Forty-three (78%) of 55 participants returned the questionnaire. The most important motivators for study participation were altruistic, i.e., a desire to help future generations at risk of colorectal cancer and personal factors including a desire to reduce one's own risk. Nineteen (44%) of 43 respondents reported that they chose to take daily aspirin post-study without knowledge of study results. At a mean follow-up of 17.3 months, 18 of these 19 subjects continued to take aspirin regularly. Regular use of vitamin supplements pre-study was found to correlate with post-study aspirin use (Mann-Whitney U test, U = 154.0; P = 0.04). We demonstrate, for the first time, that participation in a chemoprevention study can influence the decision to continue the study drug, if available, to reduce perceived cancer risk. Continued post-study aspirin intake indicates an impact of study participation on a health-related behavior and underscores the importance of patient education to guide such decision-making.

  5. Representativeness of the participants in the smoking Cessation in Pregnancy Incentives Trial (CPIT): a cross-sectional study.

    Science.gov (United States)

    Bessing, Barnabas; Bauld, Linda; Sinclair, Lesley; Mackay, Daniel F; Spence, William; Tappin, David M

    2016-08-26

    The limited representativeness of trial samples may restrict external validity. The aim of this study was to ascertain the representativeness of the population enrolled in the Cessation in Pregnancy Incentives Trial (CPIT), a therapeutic exploratory study to examine the effectiveness of financial incentives for smoking cessation during pregnancy. CPIT participants (n = 492) were compared with all self-reported smokers at maternity booking who did not participate in the trial (n = 1982). Both groups were drawn from the National Health Service (NHS) Greater Glasgow and Clyde area over a 1-year trial enrolment period. Variables used for comparison were age, area-based deprivation index, body mass index, gestation, and carbon monoxide (CO) breath test level. Chi-square and Mann-Whitney U tests were used to compare groups. From January to December 2012, 2474/13,945 (17.7 %) women, who booked for maternity care, self-reported as current smokers (at least one cigarette in the last week). Seven hundred and fifty-two were ineligible for trial participation because of a CO breath test level of less than 7 parts per million (ppm) used as a biochemical cut-off to corroborate self-report of current smoking. At telephone consent 301 could not be contacted, 11 had miscarried, 16 did not give consent and 3 opted out after randomisation, leaving 492 participants for analysis. There were no differences in demographic or clinical characteristics between trial participants, and self-reported smokers not enrolled in the trial in terms of CO breath test (as a measure of smoking level for those with a CO level of 7 ppm or higher), material deprivation (using an area-based measure), maternal age and maternal body mass index. Gestation at booking was statistically significantly lower for participants. To ensure that all trial participants were smokers, biochemical validation excluded self-reported smokers with a CO level of less than 7 ppm from taking part in the trial, which

  6. Adaptive dose-finding studies: a review of model-guided phase I clinical trials.

    Science.gov (United States)

    Iasonos, Alexia; O'Quigley, John

    2014-08-10

    We provide a comprehensive review of adaptive phase I clinical trials in oncology that used a statistical model to guide dose escalation to identify the maximum-tolerated dose (MTD). We describe the clinical setting, practical implications, and safety of such applications, with the aim of understanding how these designs work in practice. We identified 53 phase I trials published between January 2003 and September 2013 that used the continual reassessment method (CRM), CRM using escalation with overdose control, or time-to-event CRM for late-onset toxicities. Study characteristics, design parameters, dose-limiting toxicity (DLT) definition, DLT rate, patient-dose allocation, overdose, underdose, sample size, and trial duration were abstracted from each study. In addition, we examined all studies in terms of safety, and we outlined the reasons why escalations occur and under what circumstances. On average, trials accrued 25 to 35 patients over a 2-year period and tested five dose levels. The average DLT rate was 18%, which is lower than in previous reports, whereas all levels above the MTD had an average DLT rate of 36%. On average, 39% of patients were treated at the MTD, and 74% were treated at either the MTD or an adjacent level (one level above or below). This review of completed phase I studies confirms the safety and generalizability of model-guided, adaptive dose-escalation designs, and it provides an approach for using, interpreting, and understanding such designs to guide dose escalation in phase I trials. © 2014 by American Society of Clinical Oncology.

  7. Feeling Thanks and Saying Thanks: A Randomized Controlled Trial Examining If and How Socially Oriented Gratitude Journals Work.

    Science.gov (United States)

    O'Connell, Brenda H; O'Shea, Deirdre; Gallagher, Stephen

    2017-10-01

    This study examined the effect of a reflective interpersonal gratitude journal, a reflective-behavioral interpersonal gratitude journal and an active control journal, on primary qualities of well-being and depression. Participants (n = 192; 67.2% female) completed this 3-month longitudinal randomized controlled design. Participants in the reflective-behavioral condition experienced the greatest improvements in affect balance and reductions in depression at immediate posttest. Both gratitude interventions improved affect balance at 1 month, compared to the control. Changes in affect balance for those in the reflective-behavioral condition were mediated by the rate at which people expressed gratitude in their existing relationships. This effect was moderated by participant's baseline depressive status. Expressing felt gratitude to others appears to be a crucial step in deriving benefits, and these benefits may not be limited to the emotionally healthy. Given the applied popularity of gratitude interventions, understanding not only if but also how they work is essential. © 2017 Wiley Periodicals, Inc.

  8. Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy

    Science.gov (United States)

    Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra

    2013-01-01

    Introduction A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. Methods and analysis This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. Ethics and dissemination The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. Trial Registration ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN

  9. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  10. A Controlled Trial Using Natural Language Processing to Examine the Language of Suicidal Adolescents in the Emergency Department.

    Science.gov (United States)

    Pestian, John P; Grupp-Phelan, Jacqueline; Bretonnel Cohen, Kevin; Meyers, Gabriel; Richey, Linda A; Matykiewicz, Pawel; Sorter, Michael T

    2016-04-01

    What adolescents say when they think about or attempt suicide influences the medical care they receive. Mental health professionals use teenagers' words, actions, and gestures to gain insight into their emotional state and to prescribe what they believe to be optimal care. This prescription is often inconsistent among caregivers, however, and leads to varying outcomes. This variation could be reduced by applying machine learning as an aid in clinical decision support. We designed a prospective clinical trial to test the hypothesis that machine learning methods can discriminate between the conversation of suicidal and nonsuicidal individuals. Using semisupervised machine learning methods, the conversations of 30 suicidal adolescents and 30 matched controls were recorded and analyzed. The results show that the machines accurately distinguished between suicidal and nonsuicidal teenagers. © 2015 The American Association of Suicidology.

  11. The Trial of Napoleon: A Case Study for Using Mock Trials.

    Science.gov (United States)

    MacKay, Charles

    2000-01-01

    Describes a course entitled "The Trial of Napoleon Bonaparte" that focuses on a fictitious mock trial of Napoleon Bonaparte to answer the question: did Napoleon pervert or preserve the gain of the French Revolution? Discusses the strengths and weaknesses of the course. (CMK)

  12. Sex-related Impact on Clinical Outcome of Everolimus-eluting Versus Bare-metal Stents in ST-segment Myocardial Infarction. Insights From the EXAMINATION Trial.

    Science.gov (United States)

    Regueiro, Ander; Fernández-Rodríguez, Diego; Brugaletta, Salvatore; Martín-Yuste, Victoria; Masotti, Monica; Freixa, Xavier; Cequier, Ángel; Íñiguez, Andrés; Serruys, Patrick W; Sabaté, Manel

    2015-05-01

    The use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events. We aimed to evaluate the impact of sex on the performance of everolimus-eluting stents vs bare-metal stents in ST-segment elevation myocardial infarction at 2-year follow-up. This is a sub-study of the EXAMINATION trial that randomized 1498 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention to everolimus-eluting or bare-metal stents. Primary end point was combined all-cause death, any recurrent myocardial infarction, and any revascularization. All end points were analyzed according to sex at 2-year follow-up. Of 1498 patients included in the trial, 254 (17.0%) were women. Women were older and had higher prevalence of hypertension and lower prevalence of smoking compared with men. In contrast with men, stent diameter was smaller in women. After multivariate analysis, the primary end point was similar between women and men (hazard ratio=0.95; 95% confidence interval, 0.66-1.37), and among women, between those treated with bare-metal vs everolimus-eluting stents (hazard ratio=2.48; 95% confidence interval, 0.95-6.46). Women showed a lower rate of repeat revascularization than men (hazard ratio=0.55; 95% confidence interval, 0.32-0.95) despite worse baseline characteristics. This difference was driven by better performance of the everolimus-eluting stent in women. Despite poorer baseline clinical characteristics, women with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention showed outcomes similar to men. The use of everolimus-eluting stents may represent an added value in women as it showed a reduced rate of repeated revascularization compared to men. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  13. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  14. Developing complex interventions: lessons learned from a pilot study examining strategy training in acute stroke rehabilitation.

    Science.gov (United States)

    Skidmore, Elizabeth R; Dawson, Deirdre R; Whyte, Ellen M; Butters, Meryl A; Dew, Mary Amanda; Grattan, Emily S; Becker, James T; Holm, Margo B

    2014-04-01

    To examine the feasibility of a strategy training clinical trial in a small group of adults with stroke-related cognitive impairments in inpatient rehabilitation, and to explore the impact of strategy training on disability. Non-randomized two-group intervention pilot study. Two inpatient rehabilitation units within an academic health centre. Individuals with a primary diagnosis of acute stroke, who were admitted to inpatient rehabilitation and demonstrated cognitive impairments were included. Individuals with severe aphasia; dementia; major depressive disorder, bipolar, or psychotic disorder; recent drug or alcohol abuse; and anticipated length of stay less than five days were excluded. Participants received strategy training or an attention control session in addition to usual rehabilitation care. Sessions in both groups were 30-40 minutes daily, five days per week, for the duration of inpatient rehabilitation. We assessed feasibility through participants' recruitment and retention; research intervention session number and duration; participants' comprehension and engagement; intervention fidelity; and participants' satisfaction. We assessed disability at study admission, inpatient rehabilitation discharge, 3 and 6 months using the Functional Independence Measure. Participants in both groups (5 per group) received the assigned intervention (>92% planned sessions; >94% fidelity) and completed follow-up testing. Strategy training participants in this small sample demonstrated significantly less disability at six months (M (SE) = 117 (3)) than attention control participants (M(SE) = 96 (14); t 8 = 7.87, P = 0.02). It is feasible and acceptable to administer both intervention protocols as an adjunct to acute inpatient rehabilitation, and strategy training shows promise for reducing disability.

  15. Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study

    Directory of Open Access Journals (Sweden)

    Grant Adrian M

    2006-12-01

    Full Text Available Abstract Background Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS. Methods In-depth semi-structured telephone interviews were conducted in 2003–04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. Results The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. Conclusion This study highlights complex financial aspects of planning and conducting trials, especially where multiple

  16. Direct-Access Online Care for the Management of Atopic Dermatitis: A Randomized Clinical Trial Examining Patient Quality of Life.

    Science.gov (United States)

    Kornmehl, Heather; Singh, Sanminder; Johnson, Mary Ann; Armstrong, April W

    2017-09-01

    Atopic dermatitis (AD) is a chronic disease requiring regular follow-up. To increase access to dermatological care, online management of AD is being studied. However, a critical knowledge gap exists in determining AD patients' quality of life in direct-to-patient online models. In this study, we examined quality of life in AD patients managed through a direct-access online model. We randomized 156 patients to receiving care through a direct-access online platform or in person. Patients were seen for six visits over 12 months. At each visit, the patients completed Dermatology Life Quality Index/Children's Dermatology Life Quality Index (DLQI/CDLQI), and Short Form (SF-12). Between baseline and 12 months, the mean (standard deviation, SD) within-group difference in DLQI score in the online group was 4.1 (±2.3); for the in-person group, the within-group difference was 4.8 (±2.7). The mean (SD) within-group difference in CDLQI score in the online group was 4.7 (±2.8); for the in-person group, the within-group difference was 4.9 (±3.1). The mean (SD) within-group difference in physical component score (PCS) and mental component score (MCS) SF-12 scores in the online group was 6.5 (±3.8) and 8.6 (±4.3); for the in-person group, it was 6.8 (±3.2) and 9.1(±3.8), respectively. The difference in the change in DLQI, CDLQI, SF-12 PCS, and SF-12 MCS scores between the two groups was 0.72 (95% confidence interval [90% CI], -0.97 to 2.41), 0.23 (90% CI, -2.21 to 2.67), 0.34 (90% CI, -1.16 to 1.84), and 0.51 (90% CI, -1.11 to 2.13), respectively. All differences were contained within their equivalence margins. Adult and pediatric AD patients receiving direct-access online care had equivalent quality of life outcomes as those see in person. The direct-access online model has the potential to increase access to care for patients with chronic skin diseases.

  17. Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture.

    Science.gov (United States)

    Cheon, Soyeon; Park, Hi-Joon; Chae, Younbyoung; Lee, Hyangsook

    2018-01-18

    While full disclosure of information on placebo control in participant information leaflets (PILs) in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI) as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI -0.21 vs. -0.16; p = 0.38). In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference - 0.43 vs. -0.12; p = 0.03), probably due to enhanced expectations. How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we have few empirical findings on this issue, future studies are needed to

  18. Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

    Directory of Open Access Journals (Sweden)

    Soyeon Cheon

    2018-01-01

    Full Text Available Abstract Background While full disclosure of information on placebo control in participant information leaflets (PILs in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Methods Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. Results In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI −0.21 vs. −0.16; p = 0.38. In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference − 0.43 vs. −0.12; p = 0.03, probably due to enhanced expectations. Conclusions How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we

  19. Studying a disease with no home--lessons in trial recruitment from the PATCH II study.

    LENUS (Irish Health Repository)

    Thomas, Kim S

    2010-01-01

    Cellulitis is a very common condition that often recurs. The PATCH II study was designed to explore the possibility of preventing future episodes of cellulitis, with resultant cost savings for the NHS. This was the first trial to be undertaken by the UK Dermatology Clinical Trials Network. As such, it was the first to test a recruitment model that involved many busy clinicians each contributing just a few patients.

  20. A Pilot Study Examining the Effects of Time Constraints on Student Performance in Accounting Classes

    Science.gov (United States)

    Morris, David E., Sr.; Scott, John

    2017-01-01

    The purpose of this study was to examine the effects, if any, of time constraints on the success of accounting students completing exams. This study examined how time allowed to take exams affected the grades on examinations in three different accounting classes. Two were sophomore classes and one was a senior accounting class. This limited pilot…

  1. Could phase 3 medicine trials be tagged as pragmatic? A case study: The Salford COPD trial.

    Science.gov (United States)

    Dal-Ré, Rafael

    2018-02-01

    Randomized clinical trials (RCTs) can be classified as explanatory or pragmatic. Currently, explanatory and pragmatic are considered to be the extremes of a continuum: Many trials have some features of both explanatory and pragmatic RCTs. The Salford Chronic Obstructive Respiratory Disease (COPD) trial was an open-label phase 3 RCT assessing an experimental product (fluticasone furoate-vilanterol) vs usual care. The Salford investigators labelled it as "the world's first phase 3 pragmatic RCT" in COPD patients. The evaluation of the Salford trial by means of the PRECIS-2 tool, yielded a mix of both extremes (explanatory and pragmatic) with several of the 9 domains close to the explanatory extreme and few to the pragmatic one. A number of the features could not be considered as being minimal changes over usual clinical practice. Hence, it would be difficult to accept that the Salford COPD trial was a pragmatic RCT. In addition, all trial participants could have been subject to the Hawthorne effect. The scientific community needs to be rigorous enough when using certain terms related to RCT. It is clear that the Salford COPD trial had particular features-sharing some of explanatory phase 3 RCTs and some of pragmatic RCTs. This, however, is not enough to tag it as a "pragmatic" RCT providing "real-world" data. These words should not be used when referring to prelicensed RCT, unless they really describe how was the trial conducted and the type of data gathered-something that with the current clinical trial regulations will only occur in very rare circumstances. © 2017 John Wiley & Sons, Ltd.

  2. Empirical evidence of study design biases in randomized trials

    DEFF Research Database (Denmark)

    Page, Matthew J.; Higgins, Julian P. T.; Clayton, Gemma

    2016-01-01

    search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta......-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR ...) characteristic. Results: We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7...

  3. Examination of Broad Symptom Improvement Resulting From Mindfulness-Based Stress Reduction in Breast Cancer Survivors: A Randomized Controlled Trial.

    Science.gov (United States)

    Lengacher, Cecile A; Reich, Richard R; Paterson, Carly L; Ramesar, Sophia; Park, Jong Y; Alinat, Carissa; Johnson-Mallard, Versie; Moscoso, Manolete; Budhrani-Shani, Pinky; Miladinovic, Branko; Jacobsen, Paul B; Cox, Charles E; Goodman, Matthew; Kip, Kevin E

    2016-08-20

    The purpose of this randomized trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR[BC]) program in improving psychological and physical symptoms and quality of life among breast cancer survivors (BCSs) who completed treatment. Outcomes were assessed immediately after 6 weeks of MBSR(BC) training and 6 weeks later to test efficacy over an extended timeframe. A total of 322 BCSs were randomly assigned to either a 6-week MBSR(BC) program (n = 155) or a usual care group (n = 167). Psychological (depression, anxiety, stress, and fear of recurrence) and physical symptoms (fatigue and pain) and quality of life (as related to health) were assessed at baseline and at 6 and 12 weeks. Linear mixed models were used to assess MBSR(BC) effects over time, and participant characteristics at baseline were also tested as moderators of MBSR(BC) effects. Results demonstrated extended improvement for the MBSR(BC) group compared with usual care in both psychological symptoms of anxiety, fear of recurrence overall, and fear of recurrence problems and physical symptoms of fatigue severity and fatigue interference (P stress at baseline experienced the greatest benefit from MBSR(BC). The MBSR(BC) program significantly improved a broad range of symptoms among BCSs up to 6 weeks after MBSR(BC) training, with generally small to moderate overall effect sizes. © 2016 by American Society of Clinical Oncology.

  4. Exercise during and after neoadjuvant rectal cancer treatment (the EXERT trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morielli, Andria R; Usmani, Nawaid; Boulé, Normand G; Severin, Diane; Tankel, Keith; Nijjar, Tirath; Joseph, Kurian; Fairchild, Alysa; Courneya, Kerry S

    2018-01-12

    Standard treatment for locally advanced rectal cancer includes 5-6 weeks of neoadjuvant chemoradiotherapy (NACRT) followed by total mesorectal excision 6-8 weeks later. NACRT improves local disease control and surgical outcomes but also causes side effects including fatigue, diarrhea, hand-foot syndrome, and physical deconditioning that may impede quality of life (QoL), treatment completion, treatment response, and long-term prognosis. Interventions to improve treatment outcomes and manage side effects that are safe, tolerable and low-cost are highly desirable. Exercise has been shown to improve some of these outcomes in other cancer patient groups but no study to date has examined the potential benefits (and harms) of exercise training during and after NACRT for rectal cancer. The Exercise During and After Neoadjuvant Rectal Cancer Treatment (EXERT) trial is a single-center, prospective, two-armed, phase II randomized controlled trial designed to test the preliminary efficacy of exercise training in this clinical setting and to further evaluate its feasibility and safety. Participants will be 60 rectal cancer patients scheduled to receive long-course NACRT followed by total mesorectal excision. Participants will be randomly assigned to exercise training or usual care. Participants in the exercise training group will be asked to complete three supervised, high-intensity interval training sessions/week during NACRT and ≥ 150 min/week of unsupervised, moderate-to-vigorous-intensity, continuous exercise training after NACRT prior to surgery. Participants in the usual care group will be asked not to increase their exercise from baseline. Assessments will be completed pre NACRT, post NACRT, and pre surgery. The primary endpoint will be cardiorespiratory fitness (VO 2 peak) at the post-NACRT time point assessed by a graded exercise test. Secondary endpoints will include functional fitness assessed by the Senior's Fitness Test, QoL assessed by the European

  5. The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Barr, Colin; Marois, Maria; Sim, Ida; Schmid, Christopher H; Wilsey, Barth; Ward, Deborah; Duan, Naihua; Hays, Ron D; Selsky, Joshua; Servadio, Joseph; Schwartz, Marc; Dsouza, Clyde; Dhammi, Navjot; Holt, Zachary; Baquero, Victor; MacDonald, Scott; Jerant, Anthony; Sprinkle, Ron; Kravitz, Richard L

    2015-02-27

    Chronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the 'Trialist' mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain. A randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks. Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach. ClinicalTrials.gov: NCT02116621 , first registered 15 April 2014.

  6. An experimental and trial study on the second- generation MSTP

    Science.gov (United States)

    Xiao, Xiaojun; Yang, Liu; Zuo, Jian

    2004-04-01

    With the explosive growth of data services, SDH/SONET network, which is designed for voice traffic, is required to be optimized for data services. SDH-based Multi-Service Transport Platform (MSTP), which greatly improves the data capabilities of SDH networks, has been attracting much interest of vendors as well as network operators. As a leading operator in China, we have conducted a field trial study and extensive experiments on MSTP. In this paper, we present the results of our experiments. It is verified via extensive experiments that the products from some leading vendors conform to the standards. In addition, it is shown that the performance of the new value-added metro Ethernet services is highly satisfied, i.e., with tight QOS guarantees and flexible bandwidth that fits the user"s requirement exactly. We have also performed experiments for multi-vendors interoperability, and the results are highly satisfied, paving the way for large scale deployment of 2G MSTP. Our trial work showed MSTP can be used to optimize the existing metro networks, i.e., to improve the utilization of the fiber and the bandwidth that are used to carry the ADSL traffic and the IP traffic. In addition, MSTP presents a new array of opportunities for operators to increase their revenues.

  7. Clinical Trials

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...

  8. Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study.

    Science.gov (United States)

    Roseman, Michelle; Turner, Erick H; Lexchin, Joel; Coyne, James C; Bero, Lisa A; Thombs, Brett D

    2012-08-16

    To investigate the degree to which Cochrane reviews of drug interventions published in 2010 reported conflicts of interest from included trials and, among reviews that reported this information, where it was located in the review documents. Cross sectional study. Cochrane Database of Systematic Reviews. Systematic reviews of drug interventions published in 2010 in the Cochrane Database of Systematic Reviews, with review content classified as up to date in 2008 or later and with results from one or more randomised controlled trials. Of 151 included Cochrane reviews, 46 (30%, 95% confidence interval 24% to 38%) reported information on the funding sources of included trials, including 30 (20%, 14% to 27%) that reported information on trial funding for all included trials and 16 (11%, 7% to 17%) that reported for some, but not all, trials. Only 16 of the 151 Cochrane reviews (11%, 7% to 17%) provided any information on trial author-industry financial ties or trial author-industry employment. Information on trial funding and trial author-industry ties was reported in one to seven locations within each review, with no consistent reporting location observed. Most Cochrane reviews of drug trials published in 2010 did not provide information on trial funding sources or trial author-industry financial ties or employment. When this information was reported, location of reporting was inconsistent across reviews.

  9. Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy.

    Science.gov (United States)

    Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra

    2013-07-30

    A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN 8370.

  10. [Health examination in future at the era of low tuberculosis incidence--from contacts examination toward active epidemiological studies].

    Science.gov (United States)

    Maeda, Hideo; Shirai, Chika

    2013-03-01

    test in Tokyo: Hideo MAEDA (Bureau of Social Welfare and Public Health, Tokyo Metropolitan Government). 2. Contact investigation of a tuberculosis outbreak: Kenichi MIYAMOTO (Takaido Community Health Center). We have experienced a TB outbreak in integrated junior and senior high school in Tokyo. Index patient was a student with persistent respiratory symptoms for six months before diagnosis of sputum smear-positive TB. Public health center started contact investigation immediately. QFT-positive rates were high in close contacts, especially in classmates. Additionally, a student outside of contact investigation was diagnosed as TB and considered to be infected from the first patient by VNTR analysis. Therefore, public health center expanded QFT-tests to all students and teachers in this school. Finally, 9 students and 2 teachers in this school were diagnosed as sputum smear-negative TB by contact investigation. 3. Utilization of molecular epidemiological procedure in contact investigation in Kyoto City: Masahiro ITO (Public Health Center of Kyoto City) Molecular epidemiological procedure using VNTR analysis has been used for contact investigation of tuberculosis since January 2011 in Kyoto City. One hundred forty four strains of Mycobacterium tuberculosis from patients with tuberculosis were investigated and 130 strains were fully analyzed. Fourteen clusters were found and the number of strains included in the cluster was ranged from two to 11. Epidemiological relationship between patients in one cluster was found, however, significant relationship in another clusters was not demonstrated. It was suggested that VNTR analysis is useful for molecular epidemiological analysis of tuberculosis. 4. The population based molecular epidemiological studies and QFT test in a contact examination: Riyo FUJIYAMA, Keisuke MATSUBAYASHI, Setsuko MIZUSHIRI, Junko HIGUCHIL Chika SHIRAI, Yuko KATAGAMI, Mieko CHIHARA, Akihiro IJICHI (Kobe City Public Health Center), Kentaro ARIKAWA, Noriko

  11. Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

    Science.gov (United States)

    Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D

    2018-01-26

    Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board

  12. Recruitment barriers for prophylactic vaccine trials: A study in Belgium.

    Science.gov (United States)

    Harrington, Lauriane; Van Damme, Pierre; Vandermeulen, Corinne; Mali, Stéphanie

    2017-12-04

    Recruitment of volunteers is one of the main challenges in clinical trial management, and there is little information about recruitment barriers for preventative vaccine trials. We investigated both the recruitment barriers and recruitment strategies for preventive vaccine trials in Belgium. A 10 min survey was used as well as interviews of staff at all clinical trial sites in Belgium that regularly perform vaccine trials. We observed that there are successful recruitment strategies and few recruitment issues for trials involving healthy adults and those over 65 years old. However, challenges face the recruitment of paediatric populations, pregnant women, patients and the very elderly (over 85 years old). From these results, we identified three priority areas to increase recruitment for prophylactic vaccine trials in Belgium. These are: the lack of public knowledge about infectious diseases; the lack of resources of healthcare professionals to take part in clinical trials; and the burden to potential volunteers to take part in a trial. These were discussed with stakeholders and solutions were proposed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies

    Science.gov (United States)

    Page, Matthew J.; Higgins, Julian P. T.; Clayton, Gemma; Sterne, Jonathan A. C.; Hróbjartsson, Asbjørn; Savović, Jelena

    2016-01-01

    Objective To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Design Systematic review of meta-epidemiological studies. Methods We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome (“mortality” versus “other objective” versus “subjective”). Direction of effect was standardised so that ROR ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies), lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study) and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study). The influence of other characteristics (e.g. unblinded trial personnel, attrition) is unclear. Conclusions Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several characteristics, particularly attrition and selective reporting, is needed. PMID:27398997

  14. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  15. Exploring Management Strategies to Reduce Cheating in Written Examinations: Case Study of Midlands State University

    Science.gov (United States)

    Taderera, Ever; Nyikahadzoi, Loveness; Matamande, Wilson; Mandimika, Elinah

    2014-01-01

    This study was concerned about cheating in written examinations at Midlands State University (MSU). The study revealed that both male and female students cheat in written examination; business studies students cheat more than other faculties, and younger (lower class) students cheat more than (upper class) older students. Factors influencing…

  16. ‘We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact

    OpenAIRE

    Daykin, Anne; Selman, Lucy E.; Cramer, Helen; McCann, Sharon; Shorter, Gillian W.; Sydes, Matthew R.; Gamble, Carrol; Macefield, Rhiannon; Lane, J. Athene; Shaw, Alison

    2017-01-01

    BackgroundThe oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder, and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines.MethodsUsing an ethnographic study design, we observed the oversight processes of eigh...

  17. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  18. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Walker, Bruce F; Losco, Barrett; Clarke, Brenton R; Hebert, Jeff; French, Simon; Stomski, Norman J

    2011-10-31

    Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Australia and New Zealand Clinical Trials Register (ANZCTR

  19. Trial of labour in twin pregnancies: a retrospective cohort study.

    Science.gov (United States)

    de Castro, H; Haas, J; Schiff, E; Sivan, E; Yinon, Y; Barzilay, E

    2016-05-01

    To assess the success rate of vaginal delivery among women with twin pregnancies; the Twin Birth Study has shown that vaginal delivery and caesarean section are equally safe for twin delivery but >40% of the planned vaginal delivery group delivered by caesarean section. A retrospective cohort study. A tertiary medical centre. A total of 2194 women with twin pregnancies not complicated with very low birthweight. Planned mode of delivery was documented in the woman's electronic record upon entering the delivery room. Information regarding maternal age at delivery, parity, gestational age, presentation, previous history of caesarean delivery, birthweight and Apgar score was collected from the obstetric electronic charts. Rate of vaginal twin delivery. Of the 2194 women included, 1311 twin pregnancies had planned caesarean delivery and 883 underwent a trial of labour. Of the 883 women who underwent a trial of labour, the rate of vaginal delivery was 86.9%, whereas the rates of caesarean delivery and combined vaginal-caesarean delivery were 11.1% and 2.0%, respectively. Presentation of second twin, gestational age and maternal age did affect the chances of success. Nulliparity [odds ratio (OR) 2.38, 95% confidence interval (95% CI) 1.4-4.05], Foley induction of labour (OR 2.33, 95% CI 1.38-3.91) and body mass index >30 kg/m(2) (OR 1.76, 95% CI 1.03-3) were independent risk factors for caesarean delivery. The rate of vaginal delivery among women with twin pregnancies who undergo labour can be high, especially in women who laboured spontaneously and have delivered before. The rate of vaginal delivery of twins can be high, especially in women who have delivered before. © 2015 Royal College of Obstetricians and Gynaecologists.

  20. Sample size for equivalence trials: a case study from a vaccine lot consistency trial.

    Science.gov (United States)

    Ganju, Jitendra; Izu, Allen; Anemona, Alessandra

    2008-08-30

    For some trials, simple but subtle assumptions can have a profound impact on the size of the trial. A case in point is a vaccine lot consistency (or equivalence) trial. Standard sample size formulas used for designing lot consistency trials rely on only one component of variation, namely, the variation in antibody titers within lots. The other component, the variation in the means of titers between lots, is assumed to be equal to zero. In reality, some amount of variation between lots, however small, will be present even under the best manufacturing practices. Using data from a published lot consistency trial, we demonstrate that when the between-lot variation is only 0.5 per cent of the total variation, the increase in the sample size is nearly 300 per cent when compared with the size assuming that the lots are identical. The increase in the sample size is so pronounced that in order to maintain power one is led to consider a less stringent criterion for demonstration of lot consistency. The appropriate sample size formula that is a function of both components of variation is provided. We also discuss the increase in the sample size due to correlated comparisons arising from three pairs of lots as a function of the between-lot variance.

  1. A case law survey of the Personality Assessment Inventory: examining its role in civil and criminal trials.

    Science.gov (United States)

    Mullen, Kacy L; Edens, John F

    2008-05-01

    Although professional surveys suggest that the Personality Assessment Inventory (PAI; Morey, 1991) is a popular instrument among forensic and correctional psychologists, relatively little is known about the specific types of legal cases in which it is applied, the particular types of questions it is used to address, or the extent to which its admissibility has been at issue in court cases. Using a comprehensive legal database, we surveyed all published U.S., Canadian, European, and Australian criminal and civil cases in which the PAI was administered. The PAI appears to be introduced by examiners in a wide variety of civil (e.g., child custody, personal injury) and criminal (e.g., insanity, competence) cases to aid in the assessment of a broad range of psychopathology. Additionally, the PAI seems to be used frequently to assess questions concerning potential dissimulation and response styles. Surprisingly, the admissibility of the PAI into evidence was never at issue in any of the cases reviewed.

  2. Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Veroniki, Areti Angeliki; Straus, Sharon E; Ashoor, Huda; Stewart, Lesley A; Clarke, Mike; Tricco, Andrea C

    2016-03-15

    Individual patient data (IPD) meta-analysis is considered the "gold standard" for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer's dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors' response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data

  3. Clinical trial registration in physical therapy journals: a cross-sectional study.

    Science.gov (United States)

    Babu, Abraham Samuel; Veluswamy, Sundar Kumar; Rao, Pratiksha Tilak; Maiya, Arun G

    2014-01-01

    Clinical trial registration has become an important part of editorial policies of various biomedical journals, including a few physical therapy journals. However, the extent to which editorial boards enforce the need for trial registration varies across journals. The purpose of this study was to identify editorial policies and reporting of trial registration details in MEDLINE-indexed English-language physical therapy journals. This study was carried out using a cross-sectional design. Editorial policies on trial registration of MEDLINE-indexed member journals of the International Society of Physiotherapy Journal Editors (ISPJE) (Journal of Geriatric Physical Therapy, Journal of Hand Therapy, Journal of Neurologic Physical Therapy, Journal of Orthopaedic and Sports Physical Therapy, Journal of Physiotherapy [formerly Australian Journal of Physiotherapy], Journal of Science and Medicine in Sport, Manual Therapy, Physical Therapy, Physical Therapy in Sport, Physiotherapy, Physiotherapy Research International, Physiotherapy Theory and Practice, and Revista Brasileira de Fisioterapia) were reviewed in April 2013. Full texts of reports of clinical trials published in these journals between January 1, 2008, and December 31, 2012, were independently assessed for information on trial registration. Among the 13 journals, 8 recommended trial registration, and 6 emphasized prospective trial registration. As of April 2013, 4,618 articles were published between January 2008 and December 2012, of which 9% (417) were clinical trials and 29% (121/417) of these reported trial registration details. A positive trend in reporting of trial registration was observed from 2008 to 2012. The study was limited to MEDLINE-indexed ISPJE member journals. Editorial policies on trial registration of physical therapy journals and a rising trend toward reporting of trial registration details indicate a positive momentum toward trial registration. Physical therapy journal editors need to show

  4. Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies.

    Directory of Open Access Journals (Sweden)

    Matthew J Page

    Full Text Available To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials.Systematic review of meta-epidemiological studies.We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012, and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR or difference in standardised mean differences (dSMD in meta-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective". Direction of effect was standardised so that ROR < 1 and dSMD < 0 denotes a larger intervention effect estimate in trials with an inadequate or unclear (versus adequate characteristic.We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies. For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies, lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study. The influence of other characteristics (e.g. unblinded trial personnel, attrition is unclear.Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several

  5. Hypnosis for hot flashes among postmenopausal women study: A study protocol of an ongoing randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Johnson Aimee K

    2011-10-01

    cortisol. Discussion This study will be the first full scale test of hypnosis for hot flashes; one of the first studies to examine both perceived impact and physiologically measured impact of a mind-body intervention for hot flashes using state-of-the-art 24 hour ambulatory physiological monitoring; the first study to examine the effect of hypnosis for hot flashes on cortisol; and the first investigation of the role of cognitive expectancies in treatment of hot flashes in comparison to a Structured-Attention Control. Trial Registration This clinical trial has been registered with ClinicalTrials.gov, a service of the U.S. National Institutes of Health, ClinicalTrials.gov Identifier: NCT01293695.

  6. Improving precision of forage yield trials: A case study

    Science.gov (United States)

    Field-based agronomic and genetic research relies heavily on the data generated from field evaluations. Therefore, it is imperative to optimize the precision of yield estimates in cultivar evaluation trials to make reliable selections. Experimental error in yield trials is sensitive to several facto...

  7. A Randomized Controlled Trial to Investigate the Effectiveness of the Prevention of Aspiration Pneumonia Using Recommendations for Swallowing Care Guided by Ultrasound Examination.

    Science.gov (United States)

    Miura, Yuka; Nakagami, Gojiro; Yabunaka, Koichi; Tohara, Haruka; Noguchi, Hiroshi; Mori, Taketoshi; Sanada, Hiromi

    2018-02-12

    Prevention for aspiration pneumonia requires assessment of aspiration and adequate swallowing care. This randomized controlled trial aimed to investigate the effectiveness of ultrasound examination and recommendations for swallowing care for the reduction of aspiration and pharyngeal post-swallow residue as compared with standard swallowing care. Twenty-three participants were randomized to the intervention group and 23 to the control group. The intervention consisted of four ultrasound examinations during mealtimes and recommendations for swallowing care every 2 weeks during an 8 week period. No recommendations concerning swallowing care based on ultrasound examinations were provided to the control group. The frequency of aspiration or residue was defined as x/y × 100% when aspiration or residue were detected x times from y times concerning the total ultrasound measurements. The proportion of the residents with reduced frequency of aspiration which was detected by ultrasonography at eight weeks were 4.3% in the intervention group and 0% in the control group. The median reduction in the frequency of aspiration and residue in the intervention group was 31%, and that in the control group was 11%. In conclusion, swallowing care guided by frequent ultrasound examinations during mealtimes had a trend of reducing the frequency of aspiration and residue during an 8-week period in individuals relative to standard swallowing care alone.

  8. Clinical Trials

    Medline Plus

    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

  11. The BRACELET Study: surveys of mortality in UK neonatal and paediatric intensive care trials

    Directory of Open Access Journals (Sweden)

    Platt Martin

    2010-05-01

    Full Text Available Abstract Background The subject of death and bereavement in the context of randomised controlled trials in neonatal or paediatric intensive care is under-researched. The objectives of this phase of the Bereavement and RAndomised ControlLEd Trials (BRACELET Study were to determine trial activity in UK neonatal and paediatric intensive care (2002-06; numbers of deaths before hospital discharge; and variation in mortality across intensive care units and trials and to determine whether bereavement support policies were available within trials. These are essential prerequisites to considering the implications of future policies and practice subsequent to bereavement following a child's enrolment in a trial. Methods The units survey involved neonatal units providing level 2 or 3 care, and paediatric units providing level II care or above; the trials survey involved trials where allocation was randomized and interventions were delivered to intensive care patients, or to parents but designed to affect patient outcomes. Results Information was available from 191/220 (87% neonatal units (149 level 2 or 3 care; and 28/32 (88% paediatric units. 90/177 (51% eligible responding units participated in one or more trial (76 neonatal, 14 paediatric and 54 neonatal units and 6 paediatric units witnessed at least one death. 50 trials were identified (36 neonatal, 14 paediatric. 3,137 babies were enrolled in neonatal trials, 210 children in paediatric trials. Deaths ranged 0-278 (median [IQR interquartile range] 2 [1, 14.5] per neonatal trial, 0-4 (median [IQR] 1 [0, 2.5] per paediatric trial. 534 (16% participants died post-enrolment: 522 (17% in neonatal trials, 12 (6% in paediatric trials. Trial participants ranged 1-236 (median [IQR] 21.5 [8, 39.8] per neonatal unit, 1-53 (median [IQR] 11.5 [2.3, 33.8] per paediatric unit. Deaths ranged 0-37 (median [IQR] 3.5 [0.3, 8.8] per neonatal unit, 0-7 (median [IQR] 0.5 [0, 1.8] per paediatric unit. Three trials had a

  12. Skin self-examination education for early detection of melanoma: a randomized controlled trial of Internet, workbook, and in-person interventions.

    Science.gov (United States)

    Robinson, June K; Gaber, Rikki; Hultgren, Brittney; Eilers, Steven; Blatt, Hanz; Stapleton, Jerod; Mallett, Kimberly; Turrisi, Rob; Duffecy, Jenna; Begale, Mark; Martini, Mary; Bilimoria, Karl; Wayne, Jeffrey

    2014-01-13

    workbook, and 70 pairs to electronic interactive SSE educational intervention. The demographic survey data showed no significant mean differences between groups in age, education, or income. The tablet usability survey given to the first 30 tablet pairs found that, overall, participants found the electronic interactive intervention easy to use and that the video of the doctor-patient-partner dialogue accompanying the dermatologist's examination was particularly helpful in understanding what they were asked to do for the study. The interactive group proved to be just as good as the workbook group in self-confidence of scoring moles, and just as good as both the workbook and the in-person intervention groups in self-confidence of monitoring their moles. While the in-person intervention performed significantly better on a skill-based quiz, the electronic interactive group performed significantly better than the workbook group. The electronic interactive and in-person interventions were more efficient (30 minutes), while the workbook took longer (45 minutes). This study suggests that an electronic interactive intervention can deliver skills training comparable to other training methods, and the experience can be accommodated during the customary outpatient office visit with the physician. Further testing of the electronic interactive intervention's role in the anxiety of the pair and pair-discovered melanomas upon self-screening will elucidate the impact of these tools on outcomes in at-risk patient populations. ClinicalTrials.gov NCT01013844; http://clinicaltrials.gov/show/NCT01013844 (Archived by WebCite at http://www.webcitation.org/6LvGGSTKK).

  13. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial.

    Science.gov (United States)

    Sabaté, Manel; Brugaletta, Salvatore; Cequier, Angel; Iñiguez, Andrés; Serra, Antonio; Jiménez-Quevedo, Pilar; Mainar, Vicente; Campo, Gianluca; Tespili, Maurizio; den Heijer, Peter; Bethencourt, Armando; Vazquez, Nicolás; van Es, Gerrit Anne; Backx, Bianca; Valgimigli, Marco; Serruys, Patrick W

    2016-01-23

    Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial. In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087. 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047). Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction. Spanish Heart Foundation. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. [Trial of artifact reduction in body diffusion weighted imaging development and basic examination of "TRacking Only Navigator"(TRON method)].

    Science.gov (United States)

    Horie, Tomohiko; Takahara, Tarou; Ogino, Tetsuo; Okuaki, Tomoyuki; Honda, Masatoshi; Okumura, Yasuhiro; Kajihara, Nao; Usui, Keisuke; Muro, Isao; Imai, Yutaka

    2008-09-20

    In recent years, the utility of body diffusion weighted imaging as represented by diffusion weighted whole body imaging with background body signal suppression (DWIBS), the DWIBS method, is very high. However, there was a problem in the DWIBS method involving the artifact corresponding to the distance of the diaphragm. To provide a solution, the respiratory trigger (RT) method and the navigator echo method were used together. A problem was that scan time extended to the compensation and did not predict the extension rate, although both artifacts were reduced. If we used only navigator real time slice tracking (NRST) from the findings obtained by the DWIBS method, we presumed the artifacts would be ameliorable without the extension of scan time. Thus, the TRacking Only Navigator (TRON) method was developed, and a basic examination was carried out for the liver. An important feature of the TRON method is the lack of the navigator gating window (NGW) and addition of the method of linear interpolation prior to NRST. The method required the passing speed and the distance from the volunteer's diaphragm. The estimated error from the 2D-selective RF pulse (2DSRP) of the TRON method to slice excitation was calculated. The condition of 2D SRP, which did not influence the accuracy of NRST, was required by the movement phantom. The volunteer was scanned, and the evaluation and actual scan time of the image quality were compared with the RT and DWIBS methods. Diaphragm displacement speed and the quantity of displacement were determined in the head and foot directions, and the result was 9 mm/sec, and 15 mm. The estimated error was within 2.5 mm in b-factor 1000 sec/mm(2). The FA of 2DSRP was 15 degrees, and the navigator echo length was 120 mm, which was excellent. In the TRON method, the accuracy of NRST was steady because of line interpolation. The TRON method obtained image quality equal to that of the RT method with the b-factor in the volunteer scanning at short actual

  15. Ketamine analgesia for inflammatory pain in neonatal rats: a factorial randomized trial examining long-term effects

    Directory of Open Access Journals (Sweden)

    Bhutta Adnan T

    2008-08-01

    Full Text Available Abstract Background Neonatal rats exposed to repetitive inflammatory pain have altered behaviors in young adulthood, partly ameliorated by Ketamine analgesia. We examined the relationships between protein expression, neuronal survival and plasticity in the neonatal rat brain, and correlated these changes with adult cognitive behavior. Methods Using Western immunoblot techniques, homogenates of cortical tissue were analyzed from neonatal rats 18–20 hours following repeated exposure to 4% formalin injections (F, N = 9, Ketamine (K, 2.5 mg/kg × 2, N = 9, Ketamine prior to formalin (KF, N = 9, or undisturbed controls (C, N = 9. Brain tissues from another cohort of rat pups (F = 11, K = 12, KF = 10, C = 15 were used for cellular staining with Fos immunohistochemistry or FluoroJade-B (FJB, followed by cell counting in eleven cortical and three hippocampal areas. Long-term cognitive testing using a delayed non-match to sample (DNMS paradigm in the 8-arm radial maze was performed in adult rats receiving the same treatments (F = 20, K = 24, KF = 21, C = 27 in the neonatal period. Results Greater cell death occurred in F vs. C, K, KF in parietal and retrosplenial areas, vs. K, KF in piriform, temporal, and occipital areas, vs. C, K in frontal and hindlimb areas. In retrosplenial cortex, less Fos expression occurred in F vs. C, KF. Cell death correlated inversely with Fos expression in piriform, retrosplenial, and occipital areas, but only in F. Cortical expression of glial fibrillary acidic protein (GFAP was elevated in F, K and KF vs. C. No significant differences occurred in Caspase-3, Bax, and Bcl-2 expression between groups, but cellular changes in cortical areas were significantly correlated with protein expression patterns. Cluster analysis of the frequencies and durations of behaviors grouped them as exploratory, learning, preparatory, consumptive, and foraging behaviors. Neonatal inflammatory pain exposure reduced exploratory behaviors in adult

  16. Trial of artifact reduction in body diffusion weighted imaging development and basic examination of 'TRacking Only Navigator' (TRON method)

    International Nuclear Information System (INIS)

    Horie, Tomohiko; Takahara, Tarou; Ogino, Tetsuo

    2008-01-01

    In recent years, the utility of body diffusion weighted imaging as represented by diffusion weighted whole body imaging with background body signal suppression (DWIBS), the DWIBS method, is very high. However, there was a problem in the DWIBS method involving the artifact corresponding to the distance of the diaphragm. To provide a solution, the respiratory trigger (RT) method and the navigator echo method were used together. A problem was that scan time extended to the compensation and did not predict the extension rate, although both artifacts were reduced. If we used only navigator real time slice tracking (NRST) from the findings obtained by the DWIBS method, we presumed the artifacts would be ameliorable without the extension of scan time. Thus, the TRacking Only Navigator (TRON) method was developed, and a basic examination was carried out for the liver. An important feature of the TRON method is the lack of the navigator gating window (NGW) and addition of the method of linear interpolation prior to NRST. The method required the passing speed and the distance from the volunteer's diaphragm. The estimated error from the 2D-selective RF pulse (2DSRP) of the TRON method to slice excitation was calculated. The condition of 2D SRP, which did not influence the accuracy of NRST, was required by the movement phantom. The volunteer was scanned, and the evaluation and actual scan time of the image quality were compared with the RT and DWIBS methods. Diaphragm displacement speed and the quantity of displacement were determined in the head and foot directions, and the result was 9 mm/sec, and 15 mm. The estimated error was within 2.5 mm in b-factor 1000 sec/mm 2 . The FA of 2DSRP was 15 degrees, and the navigator echo length was 120 mm, which was excellent. In the TRON method, the accuracy of NRST was steady because of line interpolation. The TRON method obtained image quality equal to that of the RT method with the b-factor in the volunteer scanning at short actual

  17. The Home-Based Older People's Exercise (HOPE trial: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Forster Anne

    2011-06-01

    Full Text Available Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE trial is a two arm, assessor blind pilot randomised controlled trial (RCT to assess the effectiveness of a 12 week exercise intervention (the HOPE programme designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT, measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D quality of life measure and the geriatric depression scale (GDS, measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS, record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

  18. Proof of Learning Outcome by the Advanced Clinical Competency Examination Trial after the Long-term Student's Practice in Pharmaceutical Education.

    Science.gov (United States)

    Komori, Koji; Kataoka, Makoto; Kuramoto, Nobuyuki; Tsuji, Takumi; Nakatani, Takafumi; Yasuhara, Tomohisa; Mitamura, Shinobu; Hane, Yumiko; Ogita, Kiyokazu

    2016-01-01

    At Setsunan University, a debrief session (a poster session) is commonly performed by the students who have completed the long-term students' practice. Since the valuable changes in practical competency of the students cannot be evaluated through this session, we specified items that can help evaluate and methods that can help estimate the students' competency as clinical pharmacists. We subsequently carried out a trial called the "Advanced Clinical Competency Examination". We evaluated 103 students who had concluded the students' practice for the second period (Sep 1, 2014, to Nov 16, 2014): 70 students (called "All finish students") who had completed the practice in a hospital and pharmacy, and 33 students (called "Hospital finish students") who had finished the practice at a hospital only. The trial was executed in four stages. In the first stage, students drew pictures of something impressive they had learned during the practice. In the second stage, students were given patient cases and were asked, "What is this patient's problem?" and "How would you solve this problem?". In the third stage, the students discussed their answers in a group. In the fourth stage, each group made a poster presentation in separate rooms. By using a rubric, the teachers evaluated each student individually, the results of which showed that the "All finish students" could identify more problems than the "Hospital finish students".

  19. A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2007-12-01

    Full Text Available Abstract Background Fecal incontinence (FI is defined as the recurrent involuntary excretion of feces in inappropriate places or at inappropriate times. It is a major and highly embarrassing health care problem which affects about 2 to 24% of the adult population. The prevalence increases with age in both men and women. Physiotherapy interventions are often considered a first-line approach due to its safe and non-invasive nature when dietary and pharmaceutical treatment fails or in addition to this treatment regime. Two physiotherapy interventions, rectal balloon training (RBT and pelvic floor muscle training (PFMT are widely used in the management of FI. However, their effectiveness remains uncertain since well-designed trials on the effectiveness of RBT and PFMT versus PFMT alone in FI have never been published. Methods/Design A two-armed randomized controlled clinical trial will be conducted. One hundred and six patients are randomized to receive either PFMT combined with RBT or PFMT alone. Physicians in the University Hospital Maastricht include eligible participants. Inclusion criteria are (1 adults (aged ≥ 18 years, (2 with fecal incontinence complaints due to different etiologies persisting for at least six months, (3 having a Vaizey incontinence score of at least 12, (4 and failure of conservative treatment (including dietary adaptations and pharmacological agents. Baseline measurements consist of the Vaizey incontinence score, medical history, physical examination, medication use, anorectal manometry, rectal capacity measurement, anorectal sensation, anal endosonography, defecography, symptom diary, Fecal Incontinence Quality of Life scale (FIQL and the PREFAB-score. Follow-up measurements are scheduled at three, six and 12 months after inclusion. Skilled and registered physiotherapists experienced in women's health perform physiotherapy treatment. Twelve sessions are administered during three months according to a standardized

  20. Trial-to-Trial Fluctuations in Attentional State and Their Relation to Intelligence

    Science.gov (United States)

    Unsworth, Nash; McMillan, Brittany D.

    2014-01-01

    Trial-to-trial fluctuations in attentional state while performing measures of intelligence were examined in the current study. Participants performed various measures of fluid and crystallized intelligence while also providing attentional state ratings prior to each trial. It was found that pre-trial attentional state ratings strongly predicted…

  1. Firefighter willingness to participate in a stem cell clinical trial for burns: A mixed methods study.

    Science.gov (United States)

    Horch, Jenny D; Carr, Eloise C J; Harasym, Patricia; Burnett, Lindsay; Biernaskie, Jeff; Gabriel, Vincent

    2016-12-01

    Adult stem cells represent a potentially renewable and autologous source of cells to regenerate skin and improve wound healing. Firefighters are at risk of sustaining a burn and potentially benefiting from a split thickness skin graft (STSG). This mixed methods study examined firefighter willingness to participate in a future stem cell clinical trial, outcome priorities and factors associated with this decision. A sequential explanatory mixed methods design was used. The quantitative phase (online questionnaire) was followed by the qualitative phase (semi-structured interviews). A sample of 149 firefighters completed the online survey, and a purposeful sample of 15 firefighters was interviewed. A majority (74%) reported they would participate in a future stem cell clinical trial if they experienced burn benefiting from STSG. Hypothetical concerns related to receiving a STSG were pain, itch, scarring/redness and skin durability. Participants indicated willingness to undergo stem cell therapy if the risk of no improvement was 43% or less. Risk tolerance was predicted by perceived social support and having children. Interviews revealed four main themes: a desire to help others, improving clinical outcomes, trusting relationships, and a belief in scientific investigation. Many participants admitted lacking sufficient knowledge to make an informed decision regarding stem cell therapies. Firefighters indicated they were largely willing to participate in a stem cell clinical trial but also indicated a lack of knowledge upon which to make a decision. Public education of the role of stem cells in STSG will be increasingly important as clinical trials are developed. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  2. Study protocol: home-based telehealth stroke care: a randomized trial for veterans

    Directory of Open Access Journals (Sweden)

    McGee-Hernandez Nancy

    2010-06-01

    Full Text Available Abstract Background Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This trial examines a multifaceted telerehabilitation (TR intervention that uses telehealth technology to simultaneously evaluate the home environment, assess the patient's mobility skills, initiate rehabilitative treatment, prescribe exercises tailored for stroke patients and provide periodic goal oriented reassessment, feedback and encouragement. Methods We describe an ongoing Phase II, 2-arm, 3-site randomized controlled trial (RCT that determines primarily the effect of TR on physical function and secondarily the effect on disability, falls-related self-efficacy, and patient satisfaction. Fifty participants with a diagnosis of ischemic or hemorrhagic stroke will be randomly assigned to one of two groups: (a TR; or (b Usual Care. The TR intervention uses a combination of three videotaped visits and five telephone calls, an in-home messaging device, and additional telephonic contact as needed over a 3-month study period, to provide a progressive rehabilitative intervention with a treatment goal of safe functional mobility of the individual within an accessible home environment. Dependent variables will be measured at baseline, 3-, and 6-months and analyzed with a linear mixed-effects model across all time points. Discussion For patients recovering from stroke, the use of TR to provide home assessments and follow-up training in prescribed equipment has the potential to effectively supplement existing home health services, assist transition to home and

  3. Studying a disease with no home - lessons in trial recruitment from the PATCH II study

    Directory of Open Access Journals (Sweden)

    Thomas Kim S

    2010-03-01

    Full Text Available Abstract Background Cellulitis is a very common condition that often recurs. The PATCH II study was designed to explore the possibility of preventing future episodes of cellulitis, with resultant cost savings for the NHS. This was the first trial to be undertaken by the UK Dermatology Clinical Trials Network. As such, it was the first to test a recruitment model that involved many busy clinicians each contributing just a few patients. Methods A double-blind randomised controlled trial comparing prophylactic antibiotics (penicillin V with placebo tablets, for the prevention of repeat episodes of cellulitis of the leg. Primary outcome was time to subsequent recurrence of cellulitis. Results The PATCH II study was closed to recruitment having enrolled 123 participants from a target of 400. Whilst the recruitment period was extended by 12 months, it was not possible to continue beyond this point without additional funds. Many factors contributed to poor recruitment: (i changes in hospital policy and the introduction of community-based intravenous teams resulted in fewer cellulitis patients being admitted to hospital; ii those who were admitted were seen by many different specialties, making it difficult for a network of dermatology clinicians to identify suitable participants; and iii funding for research staff was limited to a trial manager and a trial administrator at the co-ordinating centre. With no dedicated research nurses at the recruiting centres, it was extremely difficult to maintain momentum and interest in the study. Attempts to boost recruitment by providing some financial support for principal investigators to employ local research staff was of limited success. Discussion The model of a network of busy NHS clinicians all recruiting a few patients into large clinical studies requires further testing. It did not work very well for PATCH II, but this was probably because patients were not routinely seen by dermatologists, and recruitment

  4. [Estimation of the costs of radiographic and endoscopic examinations in gastroenterology using monographic studies].

    Science.gov (United States)

    Salort, P; Rodriguez, M; Cornee, J; Berthezene, P; Sahel, J; Clement, F

    1986-01-01

    This study is devoted to the study of rate-setting and cost price of fifteen radiological and endoscopic examinations in gastroenterology as based on monographic studies. In rate-setting the costs are the examinations actually performed in the department. In contrast, the cost price allocated to include only the expenses incurred by each examination and not those related to the time running between them. Both estimations converge when rooms and equipment are used maximally. Our results show that the amounts reimbursed by the Social Security system were always lower than those obtained from monographic studies, except for two radiological examinations for which expenses were adequate. However when cost prices are considered, all reimbursements would have to be increased for endoscopic examinations, but for Radiography, only those of cholangiography, cholecystography and small bowel barium series should be adjusted.

  5. Improving recruitment to pharmacological trials for illicit opioid use: findings from a qualitative focus group study.

    Science.gov (United States)

    Neale, Joanne; Tompkins, Charlotte N E; McDonald, Rebecca; Strang, John

    2018-01-22

    To explore potential study participants' views on willingness to join clinical trials of pharmacological interventions for illicit opioid use to inform and improve future recruitment strategies. Qualitative focus group study [six groups: oral methadone (two groups); buprenorphine tablets (two groups); injectable opioid agonist treatment (one group); and former opioid agonist treatment (one group)]. Drug and alcohol services and a peer support recovery service (London, UK). Forty people with experience of opioid agonist treatment for heroin dependence (26 males, 14 females; aged 33-66 years). Data collection was facilitated by a topic guide that explored willingness to enrol in clinical pharmacological trials. Groups were audio-recorded and transcribed. Transcribed data were analysed inductively via Iterative Categorization. Participants' willingness to join pharmacological trials of medications for opioid dependence was affected by factors relating to study burden, study drug, study design, study population and study relationships. Participants worried that the trial drug might be worse than, or interfere with, their current treatment. They also misunderstood aspects of trial design despite the researchers' explanations. Recruitment of participants for clinical trials of pharmacological interventions for illicit opioid use could be improved if researchers became better at explaining clinical trials to potential participants, dispelling misconceptions about trials and increasing trust in the research process and research establishment. A checklist of issues to consider when designing pharmacological trials for illicit opioid use is proposed. © 2018 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

  6. Examination of mid-intervention mediating effects on objectively assessed sedentary time among children in the Transform-Us! cluster-randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background The optimal targets and strategies for effectively reducing sedentary behavior among young people are unknown. Intervention research that explores changes in mediated effects as well as in outcome behaviors is needed to help inform more effective interventions. Therefore, the purpose of this study was to examine the mid-intervention mediating effects on children’s objectively assessed classroom and total weekday sedentary time in the Transform-Us! intervention. Methods The results are based on 293 children, aged 7- to 9-years-old at baseline, from 20 schools in Melbourne, Australia. Each school was randomly allocated to one of four groups, which targeted reducing sedentary time in the school and family settings (SB; n = 74), increasing or maintaining moderate- to vigorous-intensity physical activity in the school and family settings (PA; n = 75), combined SB and PA (SB + PA; n = 80), or the current practice control (C; n = 64). Baseline and mid-intervention data (5–9 months) were collected in 2010 and analyzed in 2012. Classroom and total weekday sedentary time was objectively assessed using ActiGraph accelerometers. The hypothesized mediators including, child enjoyment, parent and teacher outcome expectancies, and child perceived access to standing opportunities in the classroom environment, were assessed by questionnaire. Results The SB + PA group spent 13.3 min/day less in weekday sedentary time at mid-intervention compared to the control group. At mid-intervention, children in the SB group had higher enjoyment of standing in class (0.9 units; 5-unit scale) and all intervention groups had more positive perceptions of access to standing opportunities in the classroom environment (0.3-0.4 units; 3-unit scale), compared to the control group. However, none of the hypothesized mediator variables had an effect on sedentary time; thus, no mediating effects were observed. Conclusions While beneficial intervention effects were

  7. Aspects of emotional and physical discomfort in gynecologic examination: a study of Turkish women.

    Science.gov (United States)

    Tugut, Nilufer; Golbasi, Zehra

    2014-06-01

    This cross-sectional study was carried out to determine physical and emotional discomforts experienced before and after a gynecologic examination by women who presented to the outpatient clinic of the gynecology and obstetrics department at a university hospital. The sample of study was composed of 248 women. Data were collected with a survey form developed by researchers. T-test and variance analysis were used in statistical analysis. Emotional discomfort before the examination was felt by 80.2% of the women, while 80.6% stated they felt emotional discomfort after the examination. Physical discomfort before the examination was experienced by 67.3% of the women, while 76.6% stated that they felt physical discomfort after the examination. The emotional discomfort mean score was 5.02 ± 3.24 before examination and 4.62 ± 3.23 after examination (P > 0.05). The physical discomfort mean score was 3.38 ± 3.12 before examination and 3.94 ± 3.02 after examination and the difference between mean scores was statistically significant (P examination than they anticipated beforehand. The emotional discomfort in women who preferred a female physician was significantly higher than in those who preferred a male physician or who had no preference on the sex of their physician. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

  8. The effect of a brief social intervention on the examination results of UK medical students: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dacre Jane

    2009-06-01

    Full Text Available Abstract Background Ethnic minority (EM medical students and doctors underperform academically, but little evidence exists on how to ameliorate the problem. Psychologists Cohen et al. recently demonstrated that a written self-affirmation intervention substantially improved EM adolescents' school grades several months later. Cohen et al.'s methods were replicated in the different setting of UK undergraduate medical education. Methods All 348 Year 3 white (W and EM students at one UK medical school were randomly allocated to an intervention condition (writing about one's own values or a control condition (writing about another's values, via their tutor group. Students and assessors were blind to the existence of the study. Group comparisons on post-intervention written and OSCE (clinical assessment scores adjusted for baseline written assessment scores were made using two-way analysis of covariance. All assessment scores were transformed to z-scores (mean = 0 standard deviation = 1 for ease of comparison. Comparisons between types of words used in essays were calculated using t-tests. The study was covered by University Ethics Committee guidelines. Results Groups were statistically identical at baseline on demographic and psychological factors, and analysis was by intention to treat [intervention group EM n = 95, W n = 79; control group EM n = 77; W n = 84]. As predicted, there was a significant ethnicity by intervention interaction [F(4,334 = 5.74; p = 0.017] on the written assessment. Unexpectedly, this was due to decreased scores in the W intervention group [mean difference = 0.283; (95% CI = 0.093 to 0.474] not improved EM intervention group scores [mean difference = -0.060 (95% CI = -0.268 to 0.148]. On the OSCE, both W and EM intervention groups outperformed controls [mean difference = 0.261; (95%CI = -0.047 to -0.476; p = 0.013]. The intervention group used more optimistic words (p Discussion Cohen et al.'s finding that a brief self

  9. The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial

    Directory of Open Access Journals (Sweden)

    2007-10-01

    Full Text Available Abstract Background Caesarean section is one of the most commonly performed operations on women throughout the world. Rates have increased in recent years – about 20–25% in many developed countries. Rates in other parts of the world vary widely. A variety of surgical techniques for all elements of the caesarean section operation are in use. Many have not yet been rigorously evaluated in randomised controlled trials, and it is not known whether any are associated with better outcomes for women and babies. Because huge numbers of women undergo caesarean section, even small differences in post-operative morbidity rates between techniques could translate into improved health for substantial numbers of women, and significant cost savings. Design CORONIS is a multicentre, fractional, factorial randomised controlled trial and will be conducted in centres in Argentina, Ghana, India, Kenya, Pakistan and Sudan. Women are eligible if they are undergoing their first or second caesarean section through a transverse abdominal incision. Five comparisons will be carried out in one trial, using a 2 × 2 × 2 × 2 × 2 fractional factorial design. This design has rarely been used, but is appropriate for the evaluation of several procedures which will be used together in clinical practice. The interventions are: • Blunt versus sharp abdominal entry • Exteriorisation of the uterus for repair versus intra-abdominal repair • Single versus double layer closure of the uterus • Closure versus non-closure of the peritoneum (pelvic and parietal • Chromic catgut versus Polyglactin-910 for uterine repair The primary outcome is death or maternal infectious morbidity (one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis, wound infection or peritonitis or further operative procedures; or blood transfusion. The sample size required is 15,000 women in total; at least 7,586 women

  10. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

  11. Examining physical training versus physical and mental training programmes in Swimrun semi-professional athletes: A randomised, controlled, trial

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    Francesco Chirico

    2016-11-01

    Full Text Available Objective: The purpose of this study was to identify the effect of two psychological interventions, named ‘Mental imagery’ and ‘Motivational self-talk’ training used in combination, on perceived excertion and flow state in a sample of Swimrun semi-professional athletes. Methods: Thirty male semi-professional athletes, enrolled for a Swimrun competition, were randomly selected into an experimental group (EXP and a control group (CON. The modified Borg Scale of Perceived Exertion (RPE and the Flow State Scale (FSS were the dependent variables. Before a Swimrun competition, the EXP Group performed both physical and mental training programs, while the CON group only performed a physical training program. Immediately after the race, we measured the dependent variables in both groups. Results: The results of unpaired-t test showed that levels of perceived exertion were less in EXP group than CON group, (t(28 = 12.87, P < .001, while levels of flow state were higher in EXP group than CON group (t(28 = 5.96, P < .001, immediately after the end of the endurance competition. The use of both mental imagery and self-talk training in order to reduce perceived exertion and improve flow state was supported (P < .001. Discussion and Conclusion: The findings of this study support the psychobiological model of endurance performance. Our research is the first to demonstrate that mental imagery used in combination with motivational self-talk can reduce the perceived exertion and improve the flow state in Swimrun athletes during their endurance performance.

  12. Examination of the effect of implantable cardioverter-defibrillators on health-related quality of life: based on results from the Multicenter Automatic Defibrillator Trial-II.

    Science.gov (United States)

    Noyes, Katia; Corona, Ethan; Veazie, Peter; Dick, Andrew W; Zhao, Hongwei; Moss, Arthur J

    2009-01-01

    While implantable cardioverter-defibrillators (ICDs) improve survival, their benefit in terms of health-related quality of life (HRQOL) is negligible. To examine how shocks and congestive heart failure (CHF) mediate the effect of ICDs on HRQOL. The US patients from the MADIT-II (Multicenter Automatic Defibrillator Trial-II) trial (n = 983) were randomized to receive an ICD or medical treatment only. HRQOL was assessed using the Health Utility Index 3 at baseline and 3, 12, 24, and 36 months following randomization. Logistic regressions were used to test for the effect of ICDs on the CHF indicator, and linear regressions were used to examine the effect of ICD shocks and CHF on HRQOL in living patients. We used a Monte Carlo simulation and a parametric Weibull distribution survival model to test for the effect of selective attrition. Observations were clustered by patients and robust standard errors (RSEs) were used to control for the non-independence of multiple observations provided by the same patient. Patients in the ICD arm had 41% higher odds of experiencing CHF since their last assessment compared with those in the control arm (RSE = 0.19, p = 0.01). Developing CHF reduced HRQOL at the subsequent visit by 0.07 (p < 0.01). Having ICD shocks reduced overall HRQOL by 0.04 (p = 0.04) at the subsequent assessment. The negative effect of ICD firing on HRQOL was an order of magnitude greater than the effect of CHF. A higher prevalence of CHF and shocks among patients with ICDs and their negative effect on HRQOL may partially explain the lack of HRQOL benefit of ICD therapy.

  13. Cognitive rehabiliation for Parkinson's disease demantia: a study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Martyr, Anthony; Lloyd-Williams, Huw; Brand, Andrew; Gutting, Petra; Hoare, Zoe; Edwards, Rhiannon Tudor; Clare, Linda

    2016-03-22

    There is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson's disease dementia and dementia with Lewy bodies. Cognitive rehabilitation is a goal-oriented behavioural intervention which focuses on improving everyday functioning through management of cognitive difficulties; it has been shown to be effective in Alzheimer's disease. To date, no studies have assessed its potential efficacy for addressing the impact of cognitive impairment in people with Parkinson's disease or dementia with Lewy bodies. Participants (n = 45) will be recruited from movement disorders, care for the elderly and memory clinics. Inclusion criteria include: a diagnosis of Parkinson's disease, Parkinson's disease dementia or dementia with Lewy bodies according to consensus criteria and an Addenbrooke's Cognitive Examination - III score of ≤ 82. Exclusion criteria include: a diagnosis of any other significant neurological condition; major psychiatric disorder, including depression, which is not related to the patient's Parkinson's disease and unstable medication use for their physical or cognitive symptoms. A single-blind pilot randomised controlled trial, with concurrent economic evaluation, will compare the relative efficacy of cognitive rehabilitation with that of two control conditions. Following a goal-setting interview, the participants will be randomised to one of the three study arms: cognitive rehabilitation (eight weekly sessions), relaxation therapy (eight weekly sessions) or treatment as usual. Randomisation and treatment group allocation will be carried out by a clinical trials unit using a dynamic adaptive sequential randomisation algorithm. The primary outcomes are patients' perceived goal attainment at a 2-months post-intervention assessment and a 6-months follow-up. Secondary outcomes include patients' objective cognitive performance (on tests of memory and executive function) and satisfaction with goal

  14. Role delineation and test specification validation study for the CNRN examination.

    Science.gov (United States)

    Nowin, M; Ozuna, J

    1988-10-01

    The American Board of Neuroscience Nursing conducted a role delineation and validation study to determine practice areas to be tested. In addition, weighting for each area to be included in the certification examination was determined. This article describes steps taken in the validation process and discusses findings along with application of results to certification examination revision.

  15. Learning and examination strategies: a case study of students of a ...

    African Journals Online (AJOL)

    Journal of Business Research ... Abstract. This study examines the learning strategies adopted by some students of a public university in Ghana, why they use those strategies and how they approach examinations. ... Each focus group consisted of eight students who were selected based on their academic performances.

  16. A Comparative Study Examining Academic Cohorts with Transnational Migratory Intentions towards Canada and Australia

    Science.gov (United States)

    Hopkins, John

    2016-01-01

    This research examines the issue of transnational academic mobility of academic staff, those choosing to migrate to higher education institutions in different countries as part of their career development, and performs a comparative study between the characteristics of academics examining Australia as a possible migratory destination with those…

  17. Multiple Integrated Examinations: An Observational Study of Different Academic Curricula Based on a Business Administration Assessment

    Science.gov (United States)

    Ardolino, Piermatteo; Noventa, Stefano; Formicuzzi, Maddalena; Cubico, Serena; Favretto, Giuseppe

    2016-01-01

    An observational study has been carried out to analyse differences in performance between students of different undergraduate curricula in the same written business administration examination, focusing particularly on possible effects of "integrated" or "multi-modular" examinations, a recently widespread format in Italian…

  18. Comparative Study after Hamstring Anterior Cruciate Ligament Reconstruction with Endobutton and Rigidfix: A Clinical Trial Study

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    Hamid Mousavi

    2017-01-01

    Full Text Available Background: One of the most common orthopedic clinic visits involves direct and indirect knee trauma leading to rupture of anterior cruciate ligament (ACL. Endobutton and Rigidfix are most frequent treating methods that used by orthopedic surgeons. Thus the aim of this study was compare the clinical results of reconstructing arthroscopic ACL of the knee through two methods namely Rigidfix and Endobutton. Materials and Methods: In a clinical trial study, a total of 40 patients with rupture of ACL were selected and randomly divided into two groups. The groups were treated through fixation procedures either Endobutton or Rigidfix. Prior to surgery and then at least 2 years after surgery, the patients were under physical examination in terms of knee range of motion, knee stability, knee pain, ability to perform daily activities and exercises and compared between the two groups. Results: The knee range of motion in Endobutton and Rigidfix were 135.73 ± 2.63 and 129.87 ± 7.14° resprectively (P = 0.06. comparing two groups, during last month in Endobutton and Rigidfix the frequency of knee pain were 2.5 ± 1.4 and 3.4 ± 1.4 respectively (P = 0.08. Moreover, the pain intensity score were 2.9 ± 1.5 and 2.6 ± 1.1 (P = 0.49. But there was a significant difference observed in patients' satisfaction and ability to perform sports activities. Conclusions: The two fixation methods namely Endobutton and Rigidfix are not preferred over one another. But patients' satisfaction and ability to perform sports activities in Endobutton was better than the Rigidfix.

  19. A phenomenographic study of students' conception of learning for a written examination.

    Science.gov (United States)

    Edström, Desiree W; Wilhemsson-Macleod, Niklas; Berggren, Michel; Josephson, Anna; Wahlgren, Carl-Fredrik

    2015-03-30

    We investigated students' conception of learning for an examination in internal medicine, infectious diseases and dermatology-venereology, in three separate examinations versus a single integrated one. The study was carried out during a curricular change, with one cohort belonging to a new integrated examination and the other to the former non-integrated examination. Forty-eight interviews were carried out among medical undergraduates regarding the role of the examination in the learning process. The interviews were analyzed according to the phenomenographic approach to identify the students' conception of learning. The learning approaches could be categorized in 47 of the 48 students into 4 major groups: application directed, holistic, comprehensive and tactical memorizing learning. The result indicated that comprehensive learning was the most common approach among students following either examination-form; tactical memorizing learning was more prevalent among students following the non-integrated examination and holistic learning was applied more frequently among students following the integrated examination. Nine of the 47 students changed their approaches over time, the majority switching to a comprehensive approach. No significant gender difference was observed. Comprehensive learning was the most common strategy employed and students who changed during the course most often switched to this. However, only a minor change in approach was observed after a switching to an integrated examination, i.e. it takes more than just an integrated examination to change the student's conception of learning.

  20. Balancing high accrual and ethical recruitment in paediatric oncology: a qualitative study of the 'look and feel' of clinical trial discussions

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    Eden Tim OB

    2010-10-01

    Full Text Available Abstract Background High accrual to clinical trials enables new treatment strategies to be tested rapidly, accurately and with generalisability. Ethical standards also must be high so that participation is voluntary and informed. However, this can be difficult to achieve in trials with complex designs and in those which are closely embedded in clinical practice. Optimal recruitment requires a balance of both ethical and accrual considerations. In the context of a trial of stratified treatments for children with acute lymphoblastic leukaemia (UKALL2003 we examined how recruitment looked to an observer and how it felt to the parents, to identify how doctors' communication could promote or inhibit optimal recruitment. Methods We audio-recorded, transcribed and analysed routine doctor-patient consultations (n = 20 and interviews between researchers and parents (n = 30 parents across six UK treatment centres. Analysis was informed by the constant comparative method. For consultation transcripts, analysis focussed on how doctors presented the trial. We compared this with analysis of the interview transcripts which focussed on parents' perceptions and understanding of the trial. Results Parents and doctors discussed the trial in most consultations, even those that did not involve a decision about randomisation. Doctors used language allying them both with the trial and with the parent, indicating that they were both an 'investigator' and a 'clinician'. They presented the trial both as an empirical study with a scientific imperative and also as offering personalisation of treatment for the child. Parents appeared to understand that trial involvement was voluntary, that it was different from routine care and that they could withdraw from the trial at any time. Some were confused about the significance of the MRD test and the personalisation of treatment. Conclusions Doctors communicated in ways that generally promoted optimal recruitment, indicating that

  1. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study

    Science.gov (United States)

    2014-01-01

    Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In ‘the peripheral’ model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In ‘the add-on’ model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally ‘the integral’ model played out in two ways. In ‘integral-in-theory’ studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In ‘integral-in-practice’ studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due

  2. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.

    Science.gov (United States)

    O'Cathain, Alicia; Goode, Jackie; Drabble, Sarah J; Thomas, Kate J; Rudolph, Anne; Hewison, Jenny

    2014-06-09

    Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In 'the peripheral' model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In 'the add-on' model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally 'the integral' model played out in two ways. In 'integral-in-theory' studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In 'integral-in-practice' studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research

  3. Mixed Method Study Examines Undergraduate Student Researchers’ Knowledge and Perceptions About Scholarly Communication Practices

    Directory of Open Access Journals (Sweden)

    Melissa Goertzen

    2017-09-01

    interviews consisted of four open-ended questions that further examined students’ knowledge of scholarly communication practices. The researchers coded interview transcripts and identified themes. Qualitative software was used to analyze the surveys and assess coder agreement. Finally, connections and anomalies between survey and interview results were explored. Main Results – Quantitative and qualitative data collected during the study indicate that students were most confident in their understanding of the peer-review process and data management but felt less confident in their knowledge of author and publisher rights, publication and access models, and determining the impact of scholarly research publication. In addition, they value instruction related to scholarly communication topics like the peer-review process, publication models, and data management. However, few students feel confident in their current level of knowledge or ability surrounding the previously mentioned topics. Study findings suggest that this knowledge gap is based on a lack of training or discussion of scholarly communication topics in relation to students’ research activities. Results also suggest that undergraduate students have difficulty articulating their rights as authors and their scholarly communication practices. In many cases, skill sets like data management are learned through trial and error while students progress through the research process. In some cases, faculty mentors have misperceptions and assumptions about undergraduate students’ knowledge and abilities regarding scholarly communication practices. This can create challenges for undergraduate students as they attempt to make informed decisions about research activities based on a limited foundation of experience or information. Finally, results indicate that undergraduate student researchers do not currently view the library as a place to learn about scholarly communication practices. The authors suggest that by forming

  4. WALK 2.0: Examining the effectiveness of Web 2.0 features to increase physical activity in a ‘real world’ setting: an ecological trial

    Science.gov (United States)

    Caperchione, Cristina M; Kolt, Gregory S; Savage, Trevor N; Rosenkranz, Richard R; Maeder, Anthony J; Vandelanotte, Corneel; Duncan, Mitch J; Van Itallie, Anetta; Tague, Rhys; Mummery, W Kerry

    2014-01-01

    Introduction Low levels of health-enhancing physical activity require novel approaches that have the potential to reach broad populations. Web-based interventions are a popular approach for behaviour change given their wide reach and accessibility. However, challenges with participant engagement and retention reduce the long-term maintenance of behaviour change. Web 2.0 features present a new and innovative online environment supporting greater interactivity, with the potential to increase engagement and retention. In order to understand the applicability of these innovative interventions for the broader population, ‘real-world’ interventions implemented under ‘everyday conditions’ are required. The aim of this study is to investigate the difference in physical activity behaviour between individuals using a traditional Web 1.0 website with those using a novel Web 2.0 website. Methods and analysis In this study we will aim to recruit 2894 participants. Participants will be recruited from individuals who register with a pre-existing health promotion website that currently provides Web 1.0 features (http://www.10000steps.org.au). Eligible participants who provide informed consent will be randomly assigned to one of the two trial conditions: the pre-existing 10 000 Steps website (with Web 1.0 features) or the newly developed WALK 2.0 website (with Web 2.0 features). Primary and secondary outcome measures will be assessed by self-report at baseline, 3 months and 12 months, and include: physical activity behaviour, height and weight, Internet self-efficacy, website usability, website usage and quality of life. Ethics and dissemination This study has received ethics approval from the University of Western Sydney Human Research Ethics Committee (Reference Number H8767) and has been funded by the National Health and Medical Research Council (Reference Number 589903). Study findings will be disseminated widely through peer-reviewed publications, academic

  5. Improving Diabetes care through Examining, Advising, and prescribing (IDEA): protocol for a theory-based cluster randomised controlled trial of a multiple behaviour change intervention aimed at primary healthcare professionals.

    Science.gov (United States)

    Presseau, Justin; Hawthorne, Gillian; Sniehotta, Falko F; Steen, Nick; Francis, Jill J; Johnston, Marie; Mackintosh, Joan; Grimshaw, Jeremy M; Kaner, Eileen; Elovainio, Marko; Deverill, Mark; Coulthard, Tom; Brown, Heather; Hunter, Margaret; Eccles, Martin P

    2014-05-24

    New clinical research findings may require clinicians to change their behaviour to provide high-quality care to people with type 2 diabetes, likely requiring them to change multiple different clinical behaviours. The present study builds on findings from a UK-wide study of theory-based behavioural and organisational factors associated with prescribing, advising, and examining consistent with high-quality diabetes care. To develop and evaluate the effectiveness and cost of an intervention to improve multiple behaviours in clinicians involved in delivering high-quality care for type 2 diabetes. We will conduct a two-armed cluster randomised controlled trial in 44 general practices in the North East of England to evaluate a theory-based behaviour change intervention. We will target improvement in six underperformed clinical behaviours highlighted in quality standards for type 2 diabetes: prescribing for hypertension; prescribing for glycaemic control; providing physical activity advice; providing nutrition advice; providing on-going education; and ensuring that feet have been examined. The primary outcome will be the proportion of patients appropriately prescribed and examined (using anonymised computer records), and advised (using anonymous patient surveys) at 12 months. We will use behaviour change techniques targeting motivational, volitional, and impulsive factors that we have previously demonstrated to be predictive of multiple health professional behaviours involved in high-quality type 2 diabetes care. We will also investigate whether the intervention was delivered as designed (fidelity) by coding audiotaped workshops and interventionist delivery reports, and operated as hypothesised (process evaluation) by analysing responses to theory-based postal questionnaires. In addition, we will conduct post-trial qualitative interviews with practice teams to further inform the process evaluation, and a post-trial economic analysis to estimate the costs of the

  6. Electromagnetictherapy for Treatment of Insomnia: A clinical Trial Study

    Directory of Open Access Journals (Sweden)

    Fariba Sadeghi movahhed

    2012-04-01

    Full Text Available Background & Objectives: Insomnia is one of the most common sleep disorders in the world. It causes disruption in daily activities and increases the risk of major depression. Hence, clinically the appropriate and persistent treatment of insomnia is very important. Using of hypnotic drugs such as benzodiazepines is the common treatment for insomnia but they show several side effects and it seems that new medications should be used for treatment of sleep disorders. The aim of this study was comparison between the effects of electromagnetic therapy and conventional drug usage in the treatment of insomnia.   Methods: In a blind randomized clinical trial study, 60 people referred to the private office of the psychiatrist and experienced more than 3 months extended primary insomnia were selected. They were diagnosed by DSM-IV criteria and had no other underlying problems. The subjects were divided in two groups: 30 people in each and treated electromagnetically or with Alprazolam for 3 weeks. Before treatment, immediately and one month after treatment, quality of sleep and severity of the insomnia were evaluated by using the standard questionnaires and finally, the results were analyzed statistically.   Results : In this study, 60 individuals participated from whom 28 were male (46.7% and 32 patients were female (53.3%.The mean age was 37.3 years old in a range of 17- 65. The mean point of each questionnaire, before and immediately after treatment significantly didn't show any difference but one month after treatment, there was a significant difference in both groups.   Conclusion : To treat insomnia, electromagnetic therapy appears to be used as a replacement for sedative medicines. It also has more stability in comparison with other sedative medicines and no side effects have been reported yet.

  7. Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial

    Directory of Open Access Journals (Sweden)

    Jacoby Ann

    2006-12-01

    Full Text Available Abstract Background Epilepsy is a common neurological condition, in which drugs are the mainstay of treatment and drugs trials are commonplace. Understanding why patients might or might not opt to participate in epilepsy drug trials is therefore of some importance, particularly at a time of rapid drug development and testing; and the findings may also have wider applicability. This study examined the role of patient perceptions in the decision-making process about recruitment to an RCT (the SANAD Trial that compared different antiepileptic drug treatments for the management of new-onset seizures and epilepsy. Methods In-depth interviews with 23 patients recruited from four study centres. All interviews were tape-recorded and transcribed; the transcripts were analysed thematically using a qualitative data analysis package. Results Of the nineteen informants who agreed to participate in SANAD, none agreed for purely altruistic reasons. The four informants who declined all did so for very specific reasons of self-interest. Informants' perceptions of the nature of the trial, of the drugs subject to trial, and of their own involvement were all highly influential in their decision-making. Informants either perceived the trial as potentially beneficial or unlikely to be harmful, and so agreed to participate; or as potentially harmful or unlikely to be beneficial and so declined to participate. Conclusion Most patients applied 'weak altruism', while maintaining self-interest. An emphasis on the safety and equivalence of treatments allowed some patients to be indifferent to the question of involvement. There was evidence that some participants were subject to 'therapeutic misconceptions'. The findings highlight the individual nature of trials but nonetheless raise some generic issues in relation to their design and conduct.

  8. Clinical Trials

    Medline Plus

    Full Text Available ... list of NHLBI-sponsored clinical trials. NIH Clinical Research Studies Search for studies conducted within other Institutes at the NIH, including trials performed on our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  9. A pilot study of marking accuracy and mental workload as measures of OSCE examiner performance.

    Science.gov (United States)

    Byrne, Aidan; Soskova, Tereza; Dawkins, Jayne; Coombes, Lee

    2016-07-25

    The Objective Structured Clinical Examination (OSCE) is now a standard assessment format and while examiner training is seen as essential to assure quality, there appear to be no widely accepted measures of examiner performance. The objective of this study was to determine whether the routine training provided to examiners improved their accuracy and reduced their mental workload. Accuracy was defined as the difference between the rating of each examiner and that of an expert group expressed as the mean error per item. At the same time the mental workload of each examiner was measured using a previously validated secondary task methodology. Training was not associated with an improvement in accuracy (p = 0.547) and that there was no detectable effect on mental workload. However, accuracy was improved after exposure to the same scenario (p OSCE examiners studied is not effective in improving their performance, but that average item accuracy and mental workload appear to be valid methods of assessing examiner performance.

  10. Study rationale and design of the CIMT trial: the Copenhagen Insulin and Metformin Therapy trial

    DEFF Research Database (Denmark)

    Lundby Christensen, L; Almdal, T; Boesgaard, T

    2009-01-01

    BACKGROUND: Patients with type 2 diabetes (T2DM) have an increased mortality rate primarily because of macrovascular disease. Where T2DM patients cannot be managed sufficiently through diet, exercise and peroral antidiabetic drugs, that is when haemoglobin A1c (HbA1c) is above 7.0%, it is yet...... in combination with one of three insulin analogue regimens, the primary outcome measure being carotid intima-media thickness (CIMT) in T2DM patients. DESIGN: A randomized, stratified, multicentre trial having a 2 x 3 factorial design. The metformin part is double masked and placebo controlled. The insulin...

  11. Superstition predicts favorable weight change in an open-placebo trial: a prospective study.

    Science.gov (United States)

    Rekhviashvili, Nino; Gupta, Sumati

    2015-09-01

    Given the difficulty of losing weight via adhering to healthy lifestyle choices, this study sought to understand how a placebo may elicit favorable weight change. Specifically, we examined if superstition may be related to increased responsiveness to an open-placebo. In this pilot study of 25 undergraduate participants, it was hypothesized that individuals with higher levels of superstition may be more responsive to a 3-week open-placebo weight change trial. Participants were given once-daily saltine crackers to use as open-placebos for weight change in their preferred direction (gain or loss). The weight of each participant was measured before and after the 3-week open-placebo period. A Pearson's r correlation showed a significant positive relationship between superstition and placebo responsiveness, determined by weight gain or loss in the preferred direction, r (25) = 0.493, p placebo uses for weight management.

  12. Protocol for a randomised controlled trial examining the impact of a web-based personally controlled health management system on the uptake of influenza vaccination rates

    Directory of Open Access Journals (Sweden)

    Lau Annie Y S

    2012-04-01

    Full Text Available Abstract Background Online social networking and personally controlled health management systems (PCHMS offer a new opportunity for developing innovative interventions to prevent diseases of public health concern (e.g., influenza but there are few comparative studies about patterns of use and impact of these systems. Methods/Design A 2010 CONSORT-compliant randomised controlled trial with a two-group parallel design will assess the efficacy of a web-based PCHMS called Healthy.me in facilitating the uptake of influenza vaccine amongst university students and staff. Eligible participants are randomised either to obtain access to Healthy.me or a 6-month waitlist. Participants complete pre-study, post-study and monthly surveys about their health and utilisation of health services. A post-study clinical audit will be conducted to validate self-reports about influenza vaccination and visits to the university health service due to influenza-like illness (ILI amongst a subset of participants. 600 participants older than 18 years with monthly access to the Internet and email will be recruited. Participants who (i discontinue the online registration process; (ii report obtaining an influenza vaccination in 2010 before the commencement of the study; or (iii report being influenced by other participants to undertake influenza vaccination will be excluded from analysis. The primary outcome measure is the number of participants obtaining influenza vaccination during the study. Secondary outcome measures include: number of participants (i experiencing ILI symptoms, (ii absent from or experiencing impairment in work or study due to ILI symptoms, (iii using health services or medications due to ILI symptoms; (iv expressing positive or negative attitudes or experiences towards influenza vaccination, via their reasons of receiving (or not receiving influenza vaccine; and (v their patterns of usage of Healthy.me (e.g., frequency and timing of hits, duration of

  13. Examining the Changes in Novice and Experienced Mathematics Teachers' Questioning Techniques through the Lesson Study Process

    Science.gov (United States)

    Ong, Ewe Gnoh; Lim, Chap Sam; Ghazali, Munirah

    2010-01-01

    The purpose of this study was to examine the changes in novice and experienced mathematics teachers' questioning techniques. This study was conducted in Sarawak where ten (experienced and novice) teachers from two schools underwent the lesson study process for fifteen months. Four data collection methods namely, observation, interview, lesson…

  14. Examining Technology Perception of Social Studies Teachers with Rogers' Diffusion Model

    Science.gov (United States)

    Akman, Özkan; Koçoglu, Erol

    2017-01-01

    Mobile learning has started to take place in education literature with the developing technology, and this technology started to have an increasing spread along with its advantages. This study examines the responses of social studies teachers to the innovations in the field of mobile learning. The study was designed within the framework of theory…

  15. A Qualitative Study Examining the Spatial Ability Phenomenon from the Chinese Student Perspective

    Science.gov (United States)

    Kang, Helen W.; Mohler, James L.; Choi, Soyoung; Chen, Yuehua; Zheng, Chunhui

    2011-01-01

    The authors used holistic and structured interviews to examine Chinese student perspectives on their own spatial ability. The results of this study were compared and contrast with a previous study that was conducted by Mohler (2008) of Caucasian student perspectives in United States. Findings of the current study agree with other literature that…

  16. Examination of the Professional Self-Esteem of Teacher Candidates Studying at a Faculty of Education

    Science.gov (United States)

    Aral, Neriman; Gursoy, Figen; Ceylan, Remziye; Bicakci, Mudriye Yildiz

    2009-01-01

    This study aims to determine the professional self-esteem levels of teacher candidates studying at the Faculty of Education, Ahi Evran University, Kirsehir, Turkey, to examine whether certain variables create any differences in their professional self-esteem levels and to propose suggestions in accordance with the results. The study was conducted…

  17. Process evaluation of the Data-driven Quality Improvement in Primary Care (DQIP) trial: quantitative examination of variation between practices in recruitment, implementation and effectiveness.

    Science.gov (United States)

    Dreischulte, Tobias; Grant, Aileen; Hapca, Adrian; Guthrie, Bruce

    2018-01-05

    The cluster randomised trial of the Data-driven Quality Improvement in Primary Care (DQIP) intervention showed that education, informatics and financial incentives for general medical practices to review patients with ongoing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets reduced the primary end point of high-risk prescribing by 37%, where both ongoing and new high-risk prescribing were significantly reduced. This quantitative process evaluation examined practice factors associated with (1) participation in the DQIP trial, (2) review activity (extent and nature of documented reviews) and (3) practice level effectiveness (relative reductions in the primary end point). Invited practices recruited (n=33) and not recruited (n=32) to the DQIP trial in Scotland, UK. (1) Characteristics of recruited versus non-recruited practices. Associations of (2) practice characteristics and 'adoption' (self-reported implementation work done by practices) with documented review activity and (3) of practice characteristics, DQIP adoption and review activity with effectiveness. (1) Recruited practices had lower performance in the quality and outcomes framework than those declining participation. (2) Not being an approved general practitioner training practice and higher self-reported adoption were significantly associated with higher review activity. (3) Effectiveness ranged from a relative increase in high-risk prescribing of 24.1% to a relative reduction of 77.2%. High-risk prescribing and DQIP adoption (but not documented review activity) were significantly associated with greater effectiveness in the final multivariate model, explaining 64.0% of variation in effectiveness. Intervention implementation and effectiveness of the DQIP intervention varied substantially between practices. Although the DQIP intervention primarily targeted review of ongoing high-risk prescribing, the finding that self-reported DQIP adoption was a stronger predictor of

  18. Examining the use of process evaluations of randomised controlled trials of complex interventions addressing chronic disease in primary health care-a systematic review protocol.

    Science.gov (United States)

    Liu, Hueiming; Muhunthan, Janini; Hayek, Adina; Hackett, Maree; Laba, Tracey-Lea; Peiris, David; Jan, Stephen

    2016-08-15

    Randomised controlled trials (RCTs) of complex interventions in primary health care (PHC) are needed to provide evidence-based programmes to achieve the Declaration of Alma Ata goal of making PHC equitable, accessible and universal and to effectively address the rising burden from chronic disease. Process evaluations of these RCTs can provide insight into the causal mechanisms of complex interventions, the contextual factors, and inform as to whether an intervention is ineffective due to implementation failure or failure of the intervention itself. To build on this emerging body of work, we aim to consolidate the methodology and methods from process evaluations of complex interventions in PHC and their findings of facilitators and barriers to intervention implementation in this important area of health service delivery. Systematic review of process evaluations of randomised controlled trials of complex interventions which address prevalent major chronic diseases in PHC settings. Published process evaluations of RCTs will be identified through database and clinical trial registry searches and contact with authors. Data from each study will be extracted by two reviewers using standardised forms. Data extracted include descriptive items about (1) the RCT, (2) about the process evaluations (such as methods, theories, risk of bias, analysis of process and outcome data, strengths and limitations) and (3) any stated barriers and facilitators to conducting complex interventions. A narrative synthesis of the findings will be presented. Process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts. Publishing this protocol serves to encourage transparency in the reporting of our synthesis of current literature on how process evaluations have been conducted thus far and a deeper understanding of potential challenges and solutions to aid in the implementation of effective interventions in PHC beyond

  19. Reducing patient delay in Acute Coronary Syndrome (RAPiD): research protocol for a web-based randomized controlled trial examining the effect of a behaviour change intervention.

    Science.gov (United States)

    Farquharson, Barbara; Johnston, Marie; Smith, Karen; Williams, Brian; Treweek, Shaun; Dombrowski, Stephan U; Dougall, Nadine; Abhyankar, Purva; Grindle, Mark

    2017-05-01

    To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text + visual and text-only) with usual care. Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for acute coronary syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions. A three-arm web-based, parallel randomized controlled trial of a theory-based intervention. The intervention comprises 12 behaviour change techniques systematically identified following systematic review and a consensus exercise undertaken with behaviour change experts. We aim to recruit n = 177 participants who have experienced acute coronary syndrome in the previous 6 months from a National Health Service Hospital. Consenting participants will be randomly allocated in equal numbers to one of three study groups: i) usual care, ii) usual care plus text-only behaviour change technique-based intervention or iii) usual care plus text + visual behaviour change technique-based intervention. The primary outcome will be the change in intention to phone an ambulance immediately with symptoms of acute coronary syndrome ≥15-minute duration, assessed using two randomized series of eight scenarios representing varied symptoms before and after delivery of the interventions or control condition (usual care). Funding granted January 2014. Positive results changing intentions would lead to a randomized controlled trial of the behaviour change intervention in clinical practice, assessing patient delay in the event of actual symptoms. Registered at ClinicalTrials.gov: NCT02820103. © 2016 John Wiley & Sons Ltd.

  20. Developing the Blueprint for a General Surgery Technical Skills Certification Examination: A Validation Study.

    Science.gov (United States)

    de Montbrun, Sandra; Louridas, Marisa; Szasz, Peter; Harris, Kenneth A; Grantcharov, Teodor P

    There is a recognized need to develop high-stakes technical skills assessments for decisions of certification and resident promotion. High-stakes examinations requires a rigorous approach in accruing validity evidence throughout the developmental process. One of the first steps in development is the creation of a blueprint which outlines the potential content of examination. The purpose of this validation study was to develop an examination blueprint for a Canadian General Surgery assessment of technical skill certifying examination. A Delphi methodology was used to gain consensus amongst Canadian General Surgery program directors as to the content (tasks or procedures) that could be included in a certifying Canadian General Surgery examination. Consensus was defined a priori as a Cronbach's α ≥ 0.70. All procedures or tasks reaching a positive consensus (defined as ≥80% of program directors rated items as ≥4 on the 5-point Likert scale) were then included in the final examination blueprint. Two Delphi rounds were needed to reach consensus. Of the 17 General Surgery Program directors across the country, 14 (82.4%) and 10 (58.8%) program directors responded to the first and second round, respectively. A total of 59 items and procedures reached positive consensus and were included in the final examination blueprint. The present study has outlined the development of an examination blueprint for a General Surgery certifying examination using a consensus-based methodology. This validation study will serve as the foundational work from which simulated model will be developed, pilot tested and evaluated. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  1. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Poh Catherine F

    2011-10-01

    Full Text Available Abstract Background Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. Method/Design This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160 and invasive squamous cell carcinoma (N = 240. Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm or white light-guided surgery (control arm. The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1 the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization; or 2 further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. Discussion In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS

  2. A Scoping Review of Observational Studies Examining Relationships between Environmental Behaviors and Health Behaviors

    Directory of Open Access Journals (Sweden)

    Jayne Hutchinson

    2015-05-01

    Full Text Available Individual lifestyles are key drivers of both environmental change and chronic disease. We undertook a scoping review of peer-reviewed studies which examined associations between environmental and health behaviors of individuals in high-income countries. We searched EconLit, Medline, BIOSIS and the Social Science Citation Index. A total of 136 studies were included. The majority were USA-based cross-sectional studies using self-reported measures. Most of the evidence related to travel behavior, particularly active travel (walking and cycling and physical activity (92 studies or sedentary behaviors (19 studies. Associations of public transport use with physical activity were examined in 18 studies, and with sedentary behavior in one study. Four studies examined associations between car use and physical activity. A small number included other environmental behaviors (food-related behaviors (n = 14, including organic food, locally-sourced food and plate waste and other health behaviors ((n = 20 smoking, dietary intake, alcohol. These results suggest that research on individual environmental and health behaviors consists largely of studies examining associations between travel mode and levels of physical activity. There appears to be less research on associations between other behaviors with environmental and health impacts, and very few longitudinal studies in any domain.

  3. A Scoping Review of Observational Studies Examining Relationships between Environmental Behaviors and Health Behaviors.

    Science.gov (United States)

    Hutchinson, Jayne; Prady, Stephanie L; Smith, Michaela A; White, Piran C L; Graham, Hilary M

    2015-05-05

    Individual lifestyles are key drivers of both environmental change and chronic disease. We undertook a scoping review of peer-reviewed studies which examined associations between environmental and health behaviors of individuals in high-income countries. We searched EconLit, Medline, BIOSIS and the Social Science Citation Index. A total of 136 studies were included. The majority were USA-based cross-sectional studies using self-reported measures. Most of the evidence related to travel behavior, particularly active travel (walking and cycling) and physical activity (92 studies) or sedentary behaviors (19 studies). Associations of public transport use with physical activity were examined in 18 studies, and with sedentary behavior in one study. Four studies examined associations between car use and physical activity. A small number included other environmental behaviors (food-related behaviors (n = 14), including organic food, locally-sourced food and plate waste) and other health behaviors ((n = 20) smoking, dietary intake, alcohol). These results suggest that research on individual environmental and health behaviors consists largely of studies examining associations between travel mode and levels of physical activity. There appears to be less research on associations between other behaviors with environmental and health impacts, and very few longitudinal studies in any domain.

  4. The COLOFOL trial: study design and comparison of the study population with the source cancer population

    Directory of Open Access Journals (Sweden)

    Hansdotter Andersson P

    2016-01-01

    Full Text Available Pernilla Hansdotter Andersson,1 Peer Wille-Jørgensen,2 Erzsébet Horváth-Puhó,3 Sune Høirup Petersen,2 Anna Martling,4 Henrik Toft Sørensen,3 Ingvar Syk1 On behalf of the COLOFOL Study Group 1Department of Surgery, Skåne University Hospital, Malmö, Sweden; 2Abdominal Disease Center K, Bispebjerg University Hospital, Copenhagen, Denmark; 3Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 4Department of Molecular Medicine and Surgery, Karolinska Institutet, Solna, Sweden Introduction: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. Materials and methods: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24 participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients. Results: Of a total of 4,445 eligible patients, 2,509 patients were randomized (56.4% inclusion rate. A total of 1,221 eligible patients were identified in the scrutinized hospitals, of which 684 (56% were randomized. No difference in age or sex distribution was observed between randomized and nonrandomized

  5. Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study.

    Science.gov (United States)

    Vischer, Nerina; Pfeiffer, Constanze; Kealy, Jennifer; Burri, Christian

    2017-01-01

    The trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa. We used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main themes distilled from the interviews. Protocol suitability surfaced as a prominent topic in interviews with trial staff, critiqued for its lack of clarity, implementability and adaptation to trial participants as well as to the workforce and infrastructure available. Both qualitative and quantitative investigations identified local site staff involvement in protocol development as the most helpful mean of increasing protocol suitability. Careful assessment of the local context, capacity and cultures, and ensuring that staff understand the protocol were also cited as helpful measures. Our data suggests that protocol suitability can be increased by discussing and reviewing the protocol with trial staff in advance. Involving operationally experienced staff would be most useful. For multicentre trials, we suggest that at least one trial staff member from each of the sites with the highest expected recruitment rates be involved in developing the protocol. Carefully assessing the context prior to study start is indispensable to ensuring protocol suitability and should particularly focus on the workforce and infrastructure available, as well as the needs and availability of trial participants. To allow for protocol

  6. Stimulant Reduction Intervention using Dosed Exercise (STRIDE - CTN 0037: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Morris David W

    2011-09-01

    Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions

  7. Reporting outcomes of back pain trials: A modified Delphi study

    DEFF Research Database (Denmark)

    Froud, Robert; Eldridge, Sandra; Kovacs, Francisco

    2011-01-01

    trials. METHODS: We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. Panellists developed a statement of recommendation over three online rounds. We used a modified Delphi...

  8. The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Nishi, Daisuke; Su, Kuan-Pin; Usuda, Kentaro; Chiang, Yi-Ju Jill; Guu, Tai-Wei; Hamazaki, Kei; Nakaya, Naoki; Sone, Toshimasa; Sano, Yo; Tachibana, Yoshiyuki; Ito, Hiroe; Isaka, Keiich; Hashimoto, Kenji; Hamazaki, Tomohito; Matsuoka, Yutaka J

    2016-09-15

    Maternal depression can be harmful to both mothers and their children. Omega-3 polyunsaturated fatty acid (PUFA) supplementation has been investigated as an alternative intervention for pregnant women with depressive symptoms because of the supporting evidence from clinical trials in major depression, the safety advantage, and its anti-inflammatory and neuroplasticity effects. This study examines the efficacy of omega-3 PUFA supplementation for pregnant women with depressive symptoms in Taiwan and Japan, to provide evidence available for Asia. The rationale and protocol of this trial are reported here. The Synchronized Trial on Expectant Mothers with Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) is a multicenter, double-blind, parallel group, randomized controlled trial. Participants will be randomized to either the omega-3 PUFAs arm (1,200 mg eicosapentaenoic acid and 600 mg docosahexaenoic acid daily) or placebo arm. Primary outcome is total score on the Hamilton Rating Scale for Depression (HAMD) at 12 weeks after the start of the intervention. We will randomize 56 participants to have 90 % power to detect a 4.7-point difference in mean HAMD scores with omega-3 PUFAs compared with placebo. Because seafood consumption varies across countries and this may have a major effect on the efficacy of omega-3 PUFA supplementation, 56 participants will be recruited at each site in Taiwan and Japan, for a total number of 112 participants. Secondary outcomes include depressive symptoms at 1 month after childbirth, diagnosis of major depressive disorder, changes in omega-3 PUFAs concentrations and levels of biomarkers at baseline and at 12 weeks' follow-up, and standard obstetric outcomes. Data analyses will be by intention to treat. The trial was started in June 2014 and is scheduled to end in February 2018. The trial is expected to provide evidence that can contribute to promoting mental health among mothers and children in Asian populations. Clinicaltrials.gov: NCT

  9. Intervention on whole grain with healthy balanced diet to manage childhood obesity (GReat-Child™trial): study protocol for a quasi-experimental trial.

    Science.gov (United States)

    Koo, H C; Poh, B K; Ruzita, Abd Talib

    2016-01-01

    The rapid increase in childhood obesity is a serious public health problem, and has led to the development of many interventions. However, no intervention has emphasized whole grains as a strategy to manage childhood obesity. Therefore, this article describes the protocol of a 12-week multi-component, family-based intervention on whole grain, using a healthy balanced diet for managing childhood obesity. The GReat-Child trial utilize a quasi-experimental method in which two schools in Kuala Lumpur are assigned to intervention and control groups. The eligibility criteria are overweight/obese children, aged 9 through 11 years, who has no serious co-morbidities. The children who report consuming whole-grain foods in their 3-day diet-recall during the screening will be excluded. The study sample is characterized by anthropometric measurements (weight, height, percentage of body fat and waist circumference), whole grain and nutrient intakes (3-day 24-h diet recalls), and their knowledge, attitudes and practices towards whole grain. The 12-week intervention is comprised of three components addressing behaviour, personal and environmental factors, based on social cognitive theory: (1) individual diet counselling for the parents; (2) six 30-min nutrition education classes and (3) school delivery of whole-grain foods; The control school does not receive any interventions, however, for ethical purposes, a health talk is conducted after the entire GReat-Child Trial is completed. The GReat-Child trial represents a novel approach to examining the effectiveness of the intervention of whole grain in a healthy balanced diet on managing childhood obesity. We anticipate that this trial will reveal not only whether whole grain intervention will be effective in managing childhood obesity, but also provide greater insights into the acceptance of whole grain among Malaysian children.

  10. Porvoo sarcopenia and nutrition trial: effects of protein supplementation on functional performance in home-dwelling sarcopenic older people - study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bjorkman, Mikko P; Suominen, Merja H; Pitkälä, Kaisu H; Finne-Soveri, Harriet U; Tilvis, Reijo S

    2013-11-14

    Age-related muscle loss (that is, sarcopenia) is a common health problem among older people. Physical exercise and dietary protein have been emphasized in prevention and treatment of sarcopenia. Rigorous trials investigating the effects of protein supplementation on physical performance in sarcopenic populations are still scarce. The aim of this study is to investigate the effects of protein supplementation along with simple home-based exercises on physical performance among home-dwelling sarcopenic older people. During 2012 the entire 75 and older population (N = 3,275) living in Porvoo, Finland was contacted via a postal questionnaire. Persons at risk of sarcopenia are screened with hand grip strength and gait speed. Poorly performing persons are further examined by segmental bioimpendance spectroscopy to determine their skeletal muscle index. Sarcopenic patients (target N = 250) will be enrolled in a 12-month randomized controlled trial with three arms: 1) no supplementation, 2) protein supplementation (20 grams twice a day), and 3) isocaloric placebo. All the participants will receive instructions on simple home-based exercises, dietary protein, and vitamin D supplementation (20 μg/d). The recruitment of patients will be completed during 2013. The primary endpoint of the trial is the change in short physical performance battery score and percentage of patients maintaining or improving their physical performance. Secondary endpoints will be, among other things, changes in muscle functions, nutritional status, body composition, cognition, quality of life, use of health care services, falls, and mortality. The assessment times will be 0, 6, 12 and 24 months. To our knowledge, this is the first large scale randomized controlled trial among community dwelling older people with sarcopenia that focuses on the effects of protein supplementation on physical performance. ACTRN12612001253897, date of registration 28 October 2012, first patient was randomized 11 April

  11. Corticotherapy for traumatic brain-injured Patients - The Corti-TC trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Asehnoune Karim

    2011-10-01

    Full Text Available Abstract Background Traumatic brain injury (TBI is a main cause of severe prolonged disability of young patients. Hospital acquired pneumonia (HAP add to the morbidity and mortality of traumatic brain-injured patients. In one study, hydrocortisone for treatment of traumatic-induced corticosteroid insufficiency (CI in multiple injured patients has prevented HAP, particularly in the sub-group of patients with severe TBI. Fludrocortisone is recommended in severe brain-injured patients suffering from acute subarachnoid hemorrhage. Whether an association of hydrocortisone with fludrocortisone protects from HAP and improves neurological recovery is uncertain. The aim of the current study is to compare corticotherapy to placebo for TBI patients with CI. Methods The CORTI-TC (Corticotherapy in traumatic brain-injured patients trial is a multicenter, randomized, placebo controlled, double-blind, two-arms study. Three hundred and seventy six patients hospitalized in Intensive Care Unit with a severe traumatic brain injury (Glasgow Coma Scale ≤ 8 are randomized in the first 24 hours following trauma to hydrocortisone (200 mg.day-1 for 7 days, 100 mg on days 8-9 and 50 mg on day-10 with fludrocortisone (50 μg for 10 days or double placebo. The treatment is stopped if patients have an appropriate adrenal response. The primary endpoint is HAP on day-28. The endpoint of the ancillary study is the neurological status on 6 and 12 months. Discussion The CORTI-TC trial is the first randomized controlled trial powered to investigate whether hydrocortisone with fludrocortisone in TBI patients with CI prevent HAP and improve long term recovery. Trial registration NCT01093261

  12. The Healthy Steps Study: A randomized controlled trial of a pedometer-based Green Prescription for older adults. Trial protocol

    OpenAIRE

    Kolt, Gregory S; Schofield, Grant M; Kerse, Ngaire; Garrett, Nicholas; Schluter, Philip J; Ashton, Toni; Patel, Asmita

    2009-01-01

    Abstract Background Graded health benefits of physical activity have been demonstrated for the reduction of coronary heart disease, some cancers, and type-2 diabetes, and for injury reduction and improvements in mental health. Older adults are particularly at risk of physical inactivity, and would greatly benefit from successful targeted physical activity interventions. Methods/Design The Healthy Steps study is a 12-month randomized controlled trial comparing the efficacy of a pedometer-based...

  13. Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

    NARCIS (Netherlands)

    Buch, Maya H.; Silva-Fernandez, Lucia; Carmona, Loreto; Aletaha, Daniel; Christensen, Robin; Combe, Bernard; Emery, Paul; Ferraccioli, Gianfranco; Guillemin, Francis; Kvien, Tore K.; Landewe, Robert; Pavelka, Karel; Saag, Kenneth; Smolen, Josef S.; Symmons, Deborah; van der Heijde, Désirée; Welling, Joep; Wells, George; Westhovens, Rene; Zink, Angela; Boers, Maarten

    2015-01-01

    Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. We formed a task

  14. Gross Domestic Product (GDP and productivity of schizophrenia trials: an ecological study

    Directory of Open Access Journals (Sweden)

    Fenton Mark

    2003-12-01

    Full Text Available Abstract Background The 5000 randomised controlled trials (RCTs in the Cochrane Schizophrenia Group's database affords an opportunity to research for variables related to the differences between nations of their output of schizophrenia trials. Methods Ecological study – investigating the relationship between four economic/demographic variables and number of schizophrenia RCTs per country. The variable with closest correlation was used to predict the expected number of studies. Results GDP closely correlated with schizophrenia trial output, with 76% of the total variation about the Y explained by the regression line (r = 0.87, 95% CI 0.79 to 0.92, r2 = 0.76. Many countries have a strong tradition of schizophrenia trials, exceeding their predicted output. All nations with no identified trial output had GDPs that predicted zero trial activity. Several nations with relatively small GDPs are, nevertheless, highly productive of trials. Some wealthy countries seem either not to have produced the expected number of randomised trials or not to have disseminated them to the English-speaking world. Conclusions This hypothesis-generating study could not investigate causal relationships, but suggests, that for those seeking all relevant studies, expending effort searching the scientific literature of Germany, Italy, France, Brazil and Japan may be a good investment.

  15. Gross Domestic Product (GDP) and productivity of schizophrenia trials: an ecological study.

    Science.gov (United States)

    Moll, Carina; Gessler, Ursula; Bartsch, Stephanie; El-Sayeh, Hany George; Fenton, Mark; Adams, Clive Elliott

    2003-12-05

    The 5000 randomised controlled trials (RCTs) in the Cochrane Schizophrenia Group's database affords an opportunity to research for variables related to the differences between nations of their output of schizophrenia trials. Ecological study--investigating the relationship between four economic/demographic variables and number of schizophrenia RCTs per country. The variable with closest correlation was used to predict the expected number of studies. GDP closely correlated with schizophrenia trial output, with 76% of the total variation about the Y explained by the regression line (r = 0.87, 95% CI 0.79 to 0.92, r2 = 0.76). Many countries have a strong tradition of schizophrenia trials, exceeding their predicted output. All nations with no identified trial output had GDPs that predicted zero trial activity. Several nations with relatively small GDPs are, nevertheless, highly productive of trials. Some wealthy countries seem either not to have produced the expected number of randomised trials or not to have disseminated them to the English-speaking world. This hypothesis-generating study could not investigate causal relationships, but suggests, that for those seeking all relevant studies, expending effort searching the scientific literature of Germany, Italy, France, Brazil and Japan may be a good investment.

  16. A pilot study on the quality of data management in a cancer clinical trial

    NARCIS (Netherlands)

    Putten, E. van der; Velden, J.W. van der; Siers, A.; Hamersma, E.A.M.

    Twelve institutional data managers were asked to independently code the data from a patient chart of one patient in an ovarian cancer trial. They abstracted data from the medical record and filled out three types of trial forms (on-study, chemotherapy, and summary forms). The analysis of the

  17. Conducting feasibilities in clinical trials: An investment to ensure a good study

    Directory of Open Access Journals (Sweden)

    Viraj Rajadhyaksha

    2010-01-01

    Full Text Available Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

  18. Sponsors’ participation in conduct and reporting of industry trials: a descriptive study

    Directory of Open Access Journals (Sweden)

    Lundh Andreas

    2012-08-01

    Full Text Available Abstract Background Bias in industry-sponsored trials is common and the interpretation of the results can be particularly distorted in favour of the sponsor’s product. We investigated sponsors’ involvement in the conduct and reporting of industry-sponsored trials. Methods We included all industry-sponsored trials published in The Lancet in 2008 and 2009 and corresponding trial protocols provided by The Lancet. For each protocol and publication, we extracted information on trial conduct and reporting. Results We identified 169 publications of randomised trials and included 69 (41% that were industry-sponsored, and 12 (7% industry-funded but seemingly independently conducted as a subsample. Entry of data into the study database was done independently by academic authors without the involvement of the sponsor or a contract research organisation in one of the 69 trials. Two trials had independent data analysis and one independent reporting of results. In 11 of the trials, there was a discrepancy between the information in the protocols and papers concerning who analysed the data. In four of the 12 seemingly independent trials, the protocol described sponsors’ involvement in writing the report while the published paper explicitly stated that the sponsor was not involved. Conclusions The sponsors are usually involved in the analysis and reporting of results in industry-sponsored trials, but their exact role is not always clear from the published papers. Journals should require more transparent reporting of the sponsors’ role in crucial elements such as data processing, statistical analysis and writing of the manuscript and should consider requiring access to trial protocols, independent data analysis and submission of the raw data.

  19. WALK 2.0: examining the effectiveness of Web 2.0 features to increase physical activity in a 'real world' setting: an ecological trial.

    Science.gov (United States)

    Caperchione, Cristina M; Kolt, Gregory S; Savage, Trevor N; Rosenkranz, Richard R; Maeder, Anthony J; Vandelanotte, Corneel; Duncan, Mitch J; Van Itallie, Anetta; Tague, Rhys; Mummery, W Kerry

    2014-10-10

    Low levels of health-enhancing physical activity require novel approaches that have the potential to reach broad populations. Web-based interventions are a popular approach for behaviour change given their wide reach and accessibility. However, challenges with participant engagement and retention reduce the long-term maintenance of behaviour change. Web 2.0 features present a new and innovative online environment supporting greater interactivity, with the potential to increase engagement and retention. In order to understand the applicability of these innovative interventions for the broader population, 'real-world' interventions implemented under 'everyday conditions' are required. The aim of this study is to investigate the difference in physical activity behaviour between individuals using a traditional Web 1.0 website with those using a novel Web 2.0 website. In this study we will aim to recruit 2894 participants. Participants will be recruited from individuals who register with a pre-existing health promotion website that currently provides Web 1.0 features (http://www.10000steps.org.au). Eligible participants who provide informed consent will be randomly assigned to one of the two trial conditions: the pre-existing 10 000 Steps website (with Web 1.0 features) or the newly developed WALK 2.0 website (with Web 2.0 features). Primary and secondary outcome measures will be assessed by self-report at baseline, 3 months and 12 months, and include: physical activity behaviour, height and weight, Internet self-efficacy, website usability, website usage and quality of life. This study has received ethics approval from the University of Western Sydney Human Research Ethics Committee (Reference Number H8767) and has been funded by the National Health and Medical Research Council (Reference Number 589903). Study findings will be disseminated widely through peer-reviewed publications, academic conferences and local community-based presentations. Australian New

  20. No short-cut in assessing trial quality: a case study

    Directory of Open Access Journals (Sweden)

    Hirji Karim F

    2009-01-01

    Full Text Available Abstract Background Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment. Results The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991 is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations. Conclusion A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review.

  1. Summer Study-Abroad Program as Experiential Learning: Examining Similarities and Differences in International Communication

    Science.gov (United States)

    Levine, Kenneth J.; Garland, Michelle E.

    2015-01-01

    This paper examines how the study-abroad experience enhances intercultural communication competence. This study used Bennett's (1986, 1993) model of ethnorelative typology of acceptance, adaptation, and integration to explore intercultural communication competency. Central to intercultural communication competency is intercultural sensitivity and…

  2. The On-Line Study of Sentence Comprehension: An Examination of Dual Task Paradigms

    Science.gov (United States)

    Nicol, Janet; Swinney, David; Love, Tracy; Hald, Lea

    2006-01-01

    This paper presents three studies which examine the susceptibility of sentence comprehension to intrusion by extra-sentential probe words in two on-line dual-task techniques commonly used to study sentence processing: the cross-modal lexical priming paradigm and the unimodal all-visual lexical priming paradigm. It provides both a general review…

  3. Examining College Students' Culture Learning before and after Summer Study Abroad in Japan

    Science.gov (United States)

    Paik, Chie Matsuzawa; Anzai, Shinobu; Zimmerman, Erica

    2011-01-01

    With study abroad becoming an integral part of the American higher-education curriculum, home-institution instructors face the challenge of understanding the type and content of learning taking place abroad. We report on a study conducted at a service academy on the U.S. East Coast to examine American college students' cultural learning in the…

  4. Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Yang, Feng; Li, Wen-Xiong; Liu, Zhu; Liu, Li

    2016-10-22

    Cervical spondylosis is a very common disorder and cervical spondylotic radiculopathy (CSR) is the most common form of spinal degenerative disease. Its clinical manifestations focus on pain and numbness of the neck and arm as well as restricted movement of the neck, which greatly affect the patient's life and work. The orthopedic of traditional Chinese medicine (TCM) theory holds that the basic pathologic change in spinal degenerative diseases is the imbalance between the dynamic system and the static system of the cervical spine. Based on this theory, some Chinese physicians have developed a balance chiropractic therapy (BCT) to treat CSR, which has been clinically examined for more than 50 years to effectively cure CSR. The purpose of this study is to evaluate the therapeutic effect and safety of BCT on CSR and to investigate the mechanism by which the efficacy is achieved. We propose a multicenter, parallel-group, randomized controlled trial to evaluate the efficacy and safety of BCT for CSR. Participants aged 18 to 65 years, who are in conformity with the diagnostic criteria of CSR and whose pain score on a Visual Analog Scale (VAS) is more than 4 points and less than 8 points, will be included and randomly allocated into two groups: a treatment group and a control group. Participants in the treatment group will be treated with BCT, while the control group will receive traction therapy (TT). The primary outcome is pain severity (measured with a VAS). Secondary outcomes will include cervical curvature (measured by the Borden Index), a composite of functional status (measured by the Neck Disability Index, NDI), patient health status (evaluated by the SF-36 health survey) and adverse events (AEs) as reported in the trial. If BCT can relieve neck pain without adverse effects, it may be a novel strategy for the treatment of CSR. Furthermore, the mechanism of BCT for CSR will be partially elucidated. Clinical Trials.gov Identifier: NCT02705131 . Registered on 9

  5. Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial

    Science.gov (United States)

    Fang, Jianqiao; Chen, Lifang; Chen, Luni; Wang, Chao; Keeler, Crystal Lynn; Ma, Ruijie; Xu, Shouyu; Shen, Laihua; Bao, Yehua; Ji, Conghua

    2014-01-01

    Introduction Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation. Methods and analysis 360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks’ follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events. Ethics and dissemination Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status. Trial registration number Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561 PMID:25475247

  6. Aspirin in venous leg ulcer study (ASPiVLU): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Weller, Carolina D; Barker, Anna; Darby, Ian; Haines, Terrence; Underwood, Martin; Ward, Stephanie; Aldons, Pat; Dapiran, Elizabeth; Madan, Jason J; Loveland, Paula; Sinha, Sankar; Vicaretti, Mauro; Wolfe, Rory; Woodward, Michael; McNeil, John

    2016-04-11

    Venous leg ulceration is a common and costly problem that is expected to worsen as the population ages. Current treatment is compression therapy; however, up to 50 % of ulcers remain unhealed after 2 years, and ulcer recurrence is common. New treatments are needed to address those wounds that are more challenging to heal. Targeting the inflammatory processes present in venous ulcers is a possible strategy. Limited evidence suggests that a daily dose of aspirin may be an effective adjunct to aid ulcer healing and reduce recurrence. The Aspirin in Venous Leg Ulcer study (ASPiVLU) will investigate whether 300-mg oral doses of aspirin improve time to healing. This randomised, double-blinded, multicentre, placebo-controlled, clinical trial will recruit participants with venous leg ulcers from community settings and hospital outpatient wound clinics across Australia. Two hundred sixty-eight participants with venous leg ulcers will be randomised to receive either aspirin or placebo, in addition to compression therapy, for 24 weeks. The primary outcome is time to healing within 12 weeks. Secondary outcomes are ulcer recurrence, wound pain, quality of life and wellbeing, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks. The ASPiVLU trial will investigate the efficacy and safety of aspirin as an adjunct to compression therapy to treat venous leg ulcers. Study completion is anticipated to occur in December 2018. Australian New Zealand Clinical Trials Registry, ACTRN12614000293662.

  7. [Magnetic resonance imaging (MRI) in children and adolescents – study design of a feasibility study concerning examination related emotions].

    Science.gov (United States)

    Jaite, Charlotte; Bachmann, Christian; Dewey, Marc; Weschke, Bernhard; Spors, Birgit; von Moers, Arpad; Napp, Adriane; Lehmkuhl, Ulrike; Kappel, Viola

    2013-11-01

    Numerous research centres apply magnetic resonance imaging (MRI) for research purposes in children. In view of this practical research, ethical concerns regarding the strains the study participants are exposed to during the MRI examination are discussed. The study evaluates whether an MRI examination induces negative emotions in children and adolescents which are more intense than the ones caused by electroencephalography (EEG), an examination method currently classified as causing "minimal stress." Furthermore, the emotional stress induced by the MRI examination in children and adolescents is compared with that induced in adults. The study gathers data on examination-related emotions in children (age 8-17;11, male and female) who undergo an MRI examination of the cerebrum with a medical indication. The comparison group is a sample of children and adolescents examined with EEG (age 8-17;11, male and female) as well as a sample of adults (age 18-65, male and female) examined with MRI. At present, the study is in the stage of data collection. This article presents the study design of the MRI research project.

  8. The role of physical examinations in studies of musculoskeletal disorders of the elbow

    DEFF Research Database (Denmark)

    Kryger, Ann Isabel; Lassen, C. F.; Andersen, JH

    2007-01-01

    and upper extremities, were invited to a standardised physical examination. Two independent physical examinations were performed-one blinded and one not blinded to the medical history. Information concerning musculoskeletal symptoms was obtained by a baseline questionnaire and a similar questionnaire...... and the associations were strongest with pain intensity scores given just before the examination. Physical signs were commonly found in subjects with no pain complaints. No further impact was achieved if the physical examination was not blinded to the medical history. Furthermore, the authors propose that pain......, clinical signs and disability are studied as separate outcomes, and that the diagnoses of lateral epicondylitis should be used only for cases with classical signs of inflammation reflected by severe pain, which for example conveys some disability...

  9. Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study).

    Science.gov (United States)

    Gehring, Marta; Taylor, Rod S; Mellody, Marie; Casteels, Brigitte; Piazzi, Angela; Gensini, Gianfranco; Ambrosio, Giuseppe

    2013-11-15

    Applications to run clinical trials in Europe fell 25% between 2007 and 2011. Costs, speed of approvals and shortcomings of European Clinical Trial Directive are commonly invoked to explain this unsatisfactory performance. However, no hard evidence is available on the actual weight of these factors or has it been previously investigated whether other criteria may also impact clinical trial site selection. The Survey of Attitudes towards Trial sites in Europe (SAT-EU Study) was an anonymous, cross-sectional web-based survey that systematically assessed factors impacting European clinical trial site selection. It explored 19 factors across investigator-driven, hospital-driven and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment. Clinical research organisations (CROs), academic clinical trial units (CTUs) and industry invited to respond. weight assigned to each factor hypothesised to impact trial site selection and trial incidence. Secondary outcome: desirability of European countries to run clinical trials. Responses were obtained from 485 professionals in 34 countries: 49% from BioPharma, 40% from CTUs or CROs. Investigator-dependent, environment-dependent and hospital-dependent factors were rated highly important, costs being less important (p<0.0001). Within environment-driven criteria, pool of eligible patients, speed of approvals and presence of disease-management networks were significantly more important than costs or government financial incentives (p<0.0001). The pattern of response was consistent across respondent groupings (CTU vs CRO vs industry). Considerable variability was demonstrated in the perceived receptivity of countries to undertake clinical trials, with Germany, the UK and the Netherlands rated the best trial markets (p<0.0001). Investigator-dependent factors and ease of approval dominate trial site selection, while costs appear less important. Fostering competitiveness of European clinical

  10. Randomized Controlled Trial Examining the Effects of Fish Oil and Multivitamin Supplementation on the Incorporation of n-3 and n-6 Fatty Acids into Red Blood Cells

    Directory of Open Access Journals (Sweden)

    Andrew Pipingas

    2014-05-01

    Full Text Available The present randomized, placebo-controlled, double-blind, parallel-groups clinical trial examined the effects of fish oil and multivitamin supplementation on the incorporation of n-3 and n-6 fatty acids into red blood cells. Healthy adult humans (n = 160 were randomized to receive 6 g of fish oil, 6 g of fish oil plus a multivitamin, 3 g of fish oil plus a multivitamin or a placebo daily for 16 weeks. Treatment with 6 g of fish oil, with or without a daily multivitamin, led to higher eicosapentaenoic acid (EPA composition at endpoint. Docosahexaenoic acid (DHA composition was unchanged following treatment. The long chain LC n-3 PUFA index was only higher, compared to placebo, in the group receiving the combination of 6 g of fish oil and the multivitamin. Analysis by gender revealed that all treatments increased EPA incorporation in females while, in males, EPA was only significantly increased by the 6 g fish oil multivitamin combination. There was considerable individual variability in the red blood cell incorporation of EPA and DHA at endpoint. Gender contributed to a large proportion of this variability with females generally showing higher LC n-3 PUFA composition at endpoint. In conclusion, the incorporation of LC n-3 PUFA into red blood cells was influenced by dosage, the concurrent intake of vitamin/minerals and gender.

  11. Radionuclide examination of motility disorders of the esophagus: a comparative study with manometry

    International Nuclear Information System (INIS)

    Heukelem, H.A. van.

    1985-01-01

    The primary aim of this investigation is to determine the value of radionuclide studies for clinical diagnostics in the light of its advantages over the manometric examination by means of available casuistics. A general review of the development of the examinations for assessment of the motility of the esophagus is given and both normal and disturbed motor function are described. The details of the patient groups and the techniques used in this study are presented. The results obtained for normal subjects and patients with achalasia, diffuse esophageal spasm, systemic connective tissue diseases with esophageal involvement and reflux esophagitis are reported and discussed. (Auth.)

  12. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

    International Nuclear Information System (INIS)

    Poh, Catherine F; Durham, J Scott; Brasher, Penelope M; Anderson, Donald W; Berean, Kenneth W; MacAulay, Calum E; Lee, J Jack; Rosin, Miriam P

    2011-01-01

    Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in

  13. Utility of the Physical Examination in Detecting Pulmonary Hypertension. A Mixed Methods Study

    Science.gov (United States)

    Colman, Rebecca; Whittingham, Heather; Tomlinson, George; Granton, John

    2014-01-01

    Introduction Patients with pulmonary hypertension (PH) often present with a variety of physical findings reflecting a volume or pressure overloaded right ventricle (RV). However, there is no consensus regarding the diagnostic utility of the physical examination in PH. Methods We conducted a systematic review of publications that evaluated the clinical examination and diagnosis of PH using MEDLINE (1946–2013) and EMBASE (1947–2013). We also prospectively evaluated the diagnostic utility of the physical examination findings. Patients who underwent right cardiac catheterization for any reason were recruited. After informed consent, participants were examined by 6 physicians (3 “specialists” and 3 “generalists”) who were unaware of the results of the patient's hemodynamics. Each examiner independently assessed patients for the presence of a RV lift, loud P2, jugular venous distension (JVD), tricuspid insufficiency murmur and right-sided 4th heart sound at rest and during a slow inspiration. A global rating (scale of 1–5) of the likelihood that the patient had pulmonary hypertension was provided by each examiner. Results 31 articles that assessed the physical examination in PH were included in the final analysis. There was heterogeneity amongst the studies and many did not include control data. The sign most associated with PH in the literature was a loud pulmonic component of the second heart sound (P2). In our prospective study physical examination was performed on 52 subjects (25 met criteria for PH; mPAP ≥25 mmHg). The physical sign with the highest likelihood ratio (LR) was a loud P2 on inspiration with a LR +ve 1.9, 95% CrI [1.2, 3.1] when data from all examiners was analyzed together. Results from the specialist examiners had higher diagnostic utility; a loud P2 on inspiration was associated with a positive LR of 3.2, 95% CrI [1.5, 6.2] and a right sided S4 on inspiration had a LR +ve 4.7, 95% CI [1.0, 15.6]. No aspect of the physical exam, could

  14. Peer feedback for examiner quality assurance on MRCGP International South Asia: a mixed methods study.

    Science.gov (United States)

    Perera, D P; Andrades, Marie; Wass, Val

    2017-12-08

    The International Membership Examination (MRCGP[INT]) of the Royal College of General Practitioners UK is a unique collaboration between four South Asian countries with diverse cultures, epidemiology, clinical facilities and resources. In this setting good quality assurance is imperative to achieve acceptable standards of inter rater reliability. This study aims to explore the process of peer feedback for examiner quality assurance with regard to factors affecting the implementation and acceptance of the method. A sequential mixed methods approach was used based on focus group discussions with examiners (n = 12) and clinical examination convenors who acted as peer reviewers (n = 4). A questionnaire based on emerging themes and literature review was then completed by 20 examiners at the subsequent OSCE exam. Qualitative data were analysed using an iterative reflexive process. Quantitative data were integrated by interpretive analysis looking for convergence, complementarity or dissonance. The qualitative data helped understand the issues and informed the process of developing the questionnaire. The quantitative data allowed for further refining of issues, wider sampling of examiners and giving voice to different perspectives. Examiners stated specifically that peer feedback gave an opportunity for discussion, standardisation of judgments and improved discriminatory abilities. Interpersonal dynamics, hierarchy and perception of validity of feedback were major factors influencing acceptance of feedback. Examiners desired increased transparency, accountability and the opportunity for equal partnership within the process. The process was stressful for examiners and reviewers; however acceptance increased with increasing exposure to receiving feedback. The process could be refined to improve acceptability through scrupulous attention to training and selection of those giving feedback to improve the perceived validity of feedback and improved reviewer feedback

  15. The influence of students' gender on equity in Peer Physical Examination: a qualitative study.

    Science.gov (United States)

    Vnuk, Anna K; Wearn, Andy; Rees, Charlotte E

    2017-08-01

    Peer Physical Examination (PPE) is an educational tool used globally for learning early clinical skills and anatomy. In quantitative research, there are differences in students' preferences and actual participation in PPE by gender. This novel study qualitatively explores the effect that gender has on medical students' experiences of learning physical examination through PPE. We employ an interpretative approach to uncover the PPE experiences of students from a European, graduate-entry medical school. Volunteers participated in either individual or group interviews. The data were transcribed, de-identified and analysed using thematic analysis. There was evidence of gender inequity in PPE, with students describing significant imbalances in participation. Male students adopted roles that generated significant personal discomfort and led to fewer experiences as examiners. Assumptions were made by tutors and students about gender roles: male students' ready acceptance of exposure to be examined and female students' need to be protected from particular examinations. In contrast with the first assumption, male students did feel coerced or obliged to be examined. Students described their experiences of taking action to break down the gender barrier. Importantly, students reported that tutors played a role in perpetuating inequities. These findings, whilst relating to one university, have implications for all settings where PPE is used. Educators should be vigilant about gender issues and the effect that they may have on students' participation in PPE to ensure that students are not disadvantaged in their learning.

  16. Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

    Science.gov (United States)

    Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

    2018-02-15

    There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

  17. Protocol for a randomised controlled trial examining the impact of a web-based personally controlled health management system on the uptake of influenza vaccination rates.

    Science.gov (United States)

    Lau, Annie Y S; Sintchenko, Vitali; Crimmins, Jacinta; Magrabi, Farah; Gallego, Blanca; Coiera, Enrico

    2012-04-02

    Online social networking and personally controlled health management systems (PCHMS) offer a new opportunity for developing innovative interventions to prevent diseases of public health concern (e.g., influenza) but there are few comparative studies about patterns of use and impact of these systems. A 2010 CONSORT-compliant randomised controlled trial with a two-group parallel design will assess the efficacy of a web-based PCHMS called Healthy.me in facilitating the uptake of influenza vaccine amongst university students and staff. Eligible participants are randomised either to obtain access to Healthy.me or a 6-month waitlist. Participants complete pre-study, post-study and monthly surveys about their health and utilisation of health services. A post-study clinical audit will be conducted to validate self-reports about influenza vaccination and visits to the university health service due to influenza-like illness (ILI) amongst a subset of participants. 600 participants older than 18 years with monthly access to the Internet and email will be recruited. Participants who (i) discontinue the online registration process; (ii) report obtaining an influenza vaccination in 2010 before the commencement of the study; or (iii) report being influenced by other participants to undertake influenza vaccination will be excluded from analysis. The primary outcome measure is the number of participants obtaining influenza vaccination during the study. Secondary outcome measures include: number of participants (i) experiencing ILI symptoms, (ii) absent from or experiencing impairment in work or study due to ILI symptoms, (iii) using health services or medications due to ILI symptoms; (iv) expressing positive or negative attitudes or experiences towards influenza vaccination, via their reasons of receiving (or not receiving) influenza vaccine; and (v) their patterns of usage of Healthy.me (e.g., frequency and timing of hits, duration of access, uptake of specific functions). This

  18. A trial of a job-specific workers' health surveillance program for construction workers: study protocol

    Directory of Open Access Journals (Sweden)

    Sluiter Judith K

    2011-09-01

    Full Text Available Abstract Background Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. Methods/Design The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS group (n = 206 with that of a control (WHS group (n = 206. The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. Discussion This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the

  19. Clinical study of the alveolar bone height for the dental implant using preoperative computed tomographic examination

    International Nuclear Information System (INIS)

    Sekiya, Keiko; Mori, Shintaro; Sekiya, Kotaro

    2008-01-01

    CT examination is useful for preoperative dental implant, and many studies of concerning clinical studies using CT images have been reported. However, there are few reports comparing alveolar bone heights among age groups of many cases. The purpose of this study was to evaluate the clinical studies of preoperative CT examinations for alveolar bone heights and patient ages at our department of radiology using 64 multi-detector row CT. The subjects consisted of 5174 regions in 1312 (425 males and 887 females, mean age 55.5 yrs, 16-86 yrs) cases of preoperative CT examinations, between April 2006 and December 2007. CT machine used was the Aquilion TM 64 (Toshiba Medical Systems, Japan), and the workstation used was the ZIOSTATION (ZIOSOFT, Japan). All of CT examinations were performed the position of implant placement and disease examined from CT findings. Alveolar bone heights for dental implants were examined from the CT images. For the maxilla, the alveolar bone height was the distance from the alveolar crest to the base of the nasal cavity, or the base of the maxillary sinus. For the mandible, the alveolar bone height is the distance from the alveolar crest and the upper wall of the mandibular canal, or the distance between the alveolar crest and inferior border of mandible. The numbers of the implant position were 955 site for the first molar of the mandible (the average alveolar bone height is 13.9 mm), 652 site for the second molar of the mandible (12.8 mm), and 567 site for the first molar of the maxilla (6.8 mm). In conclusion, the position where implant were to placed the most was the first molar of the mandible, and it's alveolar bone height got lower with age for women. It is over 60% of the maxillary molar area were lower 8 mm, so some kind of osteogenetic treatment was required in many cases, and hence we reassured the importance of CT. (author)

  20. Effective radiation doses of CT examinations in Japan: a nationwide questionnaire-based study

    Science.gov (United States)

    Kawaguchi, Ai; Kobayashi, Kenichi; Kobayashi, Masanao; Asada, Yasuki; Minami, Kazuyuki; Suzuki, Shoichi; Chida, Koichi

    2016-01-01

    Objective: The aims of this study were to estimate the effective radiation doses from CT examinations of both adults and children in Japan and to study the impact of various scan parameters on the effective doses. Methods: A questionnaire, which contained detailed questions on the CT scan parameters employed, was distributed to 3000 facilities throughout Japan. For each scanner protocol, the effective doses for head (non-helical and helical), chest and upper abdomen acquisitions were estimated using ImPACT CT Patient Dosimetry Calculator software v. 1.0.4 (St George's Hospital, London, UK). Results: The mean effective doses for chest and abdominal examinations using 80–110 kV were significantly lower than those using 120 kV. However, there was no statistically significant difference in the mean effective doses for head scans between facilities employing 80–110 kV and 120 kV. In chest and abdominal examinations, the mean effective doses using CT scanners from Western manufacturers [Siemens (Forchheim, Germany), Philips (Eindhoven, Netherlands) and GE Medical Systems (Milwaukee, WI)] were significantly lower than those of examinations using Japanese scanners [Hitachi (Kashiwa, Japan) and Toshiba (Otawara, Tochigi, Japan)], except for in paediatric chest examinations. Conclusion: The mean effective doses for adult head, chest and abdominal CT examinations were 2.9, 7.7 and 10.0 mSv, respectively, whereas the corresponding mean effective doses for paediatric examinations were 2.6, 7.1 and 7.7 mSv, respectively. Advances in knowledge: Facilities using CT scanners by Western manufacturers commonly adopt low-tube-voltage techniques, and low-tube-voltage CT may be useful for reducing the radiation doses to the patients, particularly for the body region. PMID:26647804

  1. Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bouwense Stefan A

    2012-11-01

    Full Text Available Abstract Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy, and uncomplicated biliary colics occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early

  2. Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Yang, Bo-Feng; Zeng, Xiang-Hong; Liu, Yan; Fu, Qing-Nan; He, Tian; Li, Fang; Shi, Guang-Xia; Liu, Bao-Zhen; Sun, San-Feng; Wang, Jun; Xiao, Lei; Deng, Yan-Mei; Liu, Cun-Zhi

    2014-11-13

    Vascular cognitive impairment, no dementia (VCIND) is a condition at risk for future dementia and should be the target of preventive strategies. Preliminary evidence suggests that acupuncture may be a clinically effective intervention for people with early-stage vascular cognitive impairment. We will do a multicenter, 6-month, drug-controlled, nonblinded, randomized, parallel-group trial to determine whether acupuncture is effective for improving cognitive function and quality of life for patients with VCIND. A total of 216 eligible patients will be recruited and randomly assigned acupuncture for two sessions/week (n = 108) or citicoline 300 mg/day (n = 108) in a multicenter, 6-month trial. The primary endpoint is cognition (Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)). Secondary endpoints include assessments of activities of daily living and behavioral symptoms (Clock Drawing Test (CDT), Activities of Daily Living (ADL) and Instrumental Activities of Daily Living scale (IADL)). This will be the first large-scale trial specifically evaluating acupuncture therapy in VCIND. If the study confirms the effectiveness and safety of acupuncture treatment, it will be important to examine how the acupuncture approach could most effectively be integrated into the provision of routine healthcare. This study is registered as an International Standard Randomised Controlled Trial on 17 January 2014, number ISRCTN 82980206.

  3. An Examination of the Adjustment Journey of International Students Studying in Australia

    Science.gov (United States)

    Kambouropoulos, Alexa

    2014-01-01

    This study examined at two Australian university campuses the types of problems that prompt international students to seek counselling services. The concerns reported by ninety students fell within three broad categories; adjustment issues, academic concerns and psychosocial problems. Follow-up interviews with a subset of these students (21) were…

  4. A Quantitative Study Examining Teacher Stress, Burnout, and Self-Efficacy

    Science.gov (United States)

    Stephenson, Timar D.

    2012-01-01

    The purpose of this quantitative, correlational study was to examine the relationships between stress, burnout, and self-efficacy in public school teachers in the Turks and Caicos Islands. The Teacher Stress Inventory was used to collect data on teacher stress, the Maslach Burnout Inventory Educators Survey was used to obtain data on teacher…

  5. Examining Current Beliefs, Practices and Barriers about Technology Integration: A Case Study

    Science.gov (United States)

    Hsu, Pi-Sui

    2016-01-01

    The purpose of this mixed-methods study was to examine the current beliefs, practices and barriers concerning technology integration of Kindergarten through Grade Six teachers in the midwestern United States. The three data collection methods were online surveys with 152 teachers as well as interviews and observations with 8 teachers. The findings…

  6. TOGAF version 9 foundation study guide preparation for the TOGAF 9 Part 1 examination

    CERN Document Server

    Harrison, Rachel

    2009-01-01

    This document is a Study Guide for TOGAF™ 9 Foundation.It gives an overview of every learning objective for the TOGAF 9 Foundation Syllabus and in-depth coverage on preparing and taking the TOGAF 9 Part 1 Examination. It is specifically designed to help individuals prepare for certification.

  7. Examining the Heterotypic Continuity of Aggression Using Teacher Reports: Results from a National Canadian Study

    Science.gov (United States)

    Miller, Jessie L.; Vaillancourt, Tracy; Boyle, Michael H.

    2009-01-01

    This study examined the heterotypic continuity of aggression hypothesis (physical to indirect) using independent teacher reports of aggression drawn from a nationally representative sample of 749 Canadian girls and boys. Confirmatory factor analysis using an accelerated longitudinal design confirmed a two-factor model of physical and indirect…

  8. Examining an Evolution: A Case Study of Organizational Change Accompanying the Community College Baccalaureate

    Science.gov (United States)

    McKinney, Lyle; Morris, Phillip A.

    2010-01-01

    This study examined the nature and degree of organizational change that occurs when community colleges offer their own baccalaureate degree programs. Utilizing qualitative research methodology, we investigated how executive administrators at two Florida colleges managed this momentous change process and how this transformation has affected their…

  9. Diagnostic X-ray examinations and increased chromosome translocations: evidence from three studies.

    Science.gov (United States)

    Bhatti, Parveen; Yong, Lee C; Doody, Michele M; Preston, Dale L; Kampa, Diane M; Ramsey, Marilyn J; Ward, Elizabeth M; Edwards, Alan A; Ron, Elaine; Tucker, James D; Sigurdson, Alice J

    2010-11-01

    Controversy regarding potential health risks from increased use of medical diagnostic radiologic examinations has come to public attention. We evaluated whether chromosome damage, specifically translocations, which are a potentially intermediate biomarker for cancer risk, was increased after exposure to diagnostic X-rays, with particular interest in the ionizing radiation dose-response below the level of approximately 50 mGy. Chromosome translocation frequency data from three separately conducted occupational studies of ionizing radiation were pooled together. Studies 1 and 2 included 79 and 150 medical radiologic technologists, respectively, and study 3 included 83 airline pilots and 50 university faculty members (total = 155 women and 207 men; mean age = 62 years, range 34-90). Information on personal history of radiographic examinations was collected from a detailed questionnaire. We computed a cumulative red bone marrow (RBM) dose score based on the numbers and types of X-ray examinations reported with 1 unit approximating 1 mGy. Poisson regression analyses were adjusted for age and laboratory method. Mean RBM dose scores were 49, 42, and 11 for Studies 1-3, respectively (overall mean = 33.5, range 0-303). Translocation frequencies significantly increased with increasing dose score (P X-ray examinations, including dose scores of approximately 50 and lower, suggesting the possibility of long-term adverse health effects.

  10. Using Peer Reviews to Examine Micropolitics and Disciplinary Development of Engineering Education: A Case Study

    Science.gov (United States)

    Beddoes, Kacey

    2014-01-01

    This article presents a case study of the peer review process for a feminist article submitted to an engineering education journal. It demonstrates how an examination of peer review can be a useful approach to further understanding the development of feminist thought in education fields. Rather than opposition to feminist thought per se, my…

  11. Examining Elementary Teachers' Use of Online Learning Environments: An Exploratory Study

    Science.gov (United States)

    Beach, Pamela

    2018-01-01

    This article presents the results of a study that examined elementary teachers' use of online learning environments for their informal professional learning in literacy instruction. Forty-five elementary teachers from a metropolitan area in Ontario, Canada, completed an online survey and participated in a semistructured interview. Survey and…

  12. A pilot study on the quality of data management in a cancer clinical trial.

    Science.gov (United States)

    van der Putten, E; van der Velden, J W; Siers, A; Hamersma, E A

    1987-06-01

    Twelve institutional data managers were asked to independently code the data from a patient chart of one patient in an ovarian cancer trial. They abstracted data from the medical record and filled out three types of trial forms (on-study, chemotherapy, and summary forms). The analysis of the processed data revealed that the median rate of errors was 13% for the 12 data managers. The error rate differed among the types of trial forms. The factors causing these errors were mistakes in interpretation, documentation, and coding. The level of experience of the data managers proved to be an important factor. It became clear that the documentation in the medical record was inadequate. We conclude that data managers as well as physicians involved in cancer clinical trials need specific training and that the quality of data management in cancer clinical trials is an important issue for further investigation.

  13. Analysis on actual state of selective upper gastrointestinal study in medical examination

    Energy Technology Data Exchange (ETDEWEB)

    Kang, Seong Ho; Son, Soon Yong; Joo, Mi Hwa; Kim, Chang Bok; Kim, Keon Chung [Asan Medical Center, Asan (Korea, Republic of)

    1999-04-01

    The purpose of this study is to present controversial point and reform measurements by analysing factors having important effect on selection of upper gastrointestinal study in total health promotion. We examined 200 persons for this study, who visited for upper gastrointestinal study from January to February in 1999. We classified this group into Endoscopy, Upper gastrointestinal series, and sleeping endoscopy. We also investigated standard of satisfaction and factors having effect on selection of each study. As is results, in the motive of selection, Item of 'making accurate observation' and 'without pain' was 39.3% and 34.7%, respectively. In this study, sleeping endoscopy was 45.7%, but on the other side upper gastrointestinal series was low 22.6%(P<0.05). In the standard of preference of study, the man was 55.7% in the endoscopy, and the woman was 61.8% in the upper gastrointestinal series(P<0.05). The standard of preference of upper gastrointestinal series show that it was satisfied on the whole irrespective of sex, dwelling place, age, occupation, and level of education. In the selection of study, one's own will was showed the highest frequency, and family inducement was showed second(P<0.05). Persons over 60% were examined before the same study. Selection of upper gastrointestinal series was 47.9% of person with normal findings, and endoscopy and sleeping endoscopy was over 70% with gastritis, gastric and duodenal(P<0.01). For one's accurate selection of examination, it is important that objective and credible information should be given to a recipient for examination.

  14. Analysis on actual state of selective upper gastrointestinal study in medical examination

    International Nuclear Information System (INIS)

    Kang, Seong Ho; Son, Soon Yong; Joo, Mi Hwa; Kim, Chang Bok; Kim, Keon Chung

    1999-01-01

    The purpose of this study is to present controversial point and reform measurements by analysing factors having important effect on selection of upper gastrointestinal study in total health promotion. We examined 200 persons for this study, who visited for upper gastrointestinal study from January to February in 1999. We classified this group into Endoscopy, Upper gastrointestinal series, and sleeping endoscopy. We also investigated standard of satisfaction and factors having effect on selection of each study. As is results, in the motive of selection, Item of 'making accurate observation' and 'without pain' was 39.3% and 34.7%, respectively. In this study, sleeping endoscopy was 45.7%, but on the other side upper gastrointestinal series was low 22.6%(P<0.05). In the standard of preference of study, the man was 55.7% in the endoscopy, and the woman was 61.8% in the upper gastrointestinal series(P<0.05). The standard of preference of upper gastrointestinal series show that it was satisfied on the whole irrespective of sex, dwelling place, age, occupation, and level of education. In the selection of study, one's own will was showed the highest frequency, and family inducement was showed second(P<0.05). Persons over 60% were examined before the same study. Selection of upper gastrointestinal series was 47.9% of person with normal findings, and endoscopy and sleeping endoscopy was over 70% with gastritis, gastric and duodenal(P<0.01). For one's accurate selection of examination, it is important that objective and credible information should be given to a recipient for examination

  15. Clinical Trials

    Medline Plus

    Full Text Available ... are doctors, statisticians, and community members. The IRB's purpose is to ensure that clinical trials are ethical ... enrolling in a clinical trial: What is the purpose of the study? Who is sponsoring the study, ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...

  19. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  20. Real-life COPD patients compared to large trial populations : An UNLOCK external validity study

    NARCIS (Netherlands)

    Kruis, Annemarije; Ställberg, Bjorn; Jones, Rupert; Tsiligianni, Ioanna; Kocks, Jan Willem; Van Der Molen, Thys; Chavannes, Niels

    2013-01-01

    Objective To investigate the external validity of six large randomized controlled medication trials (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) compared to the COPD population seen in the community, and to examine the proportion of patients in the community that would be selected based on

  1. Text for context, trial for trialogue: An ethnographic study of a fictive interaction blend

    NARCIS (Netherlands)

    Pascual Olive, E.

    2008-01-01

    This paper deals with a prosecutor's closing argument in a murder trial I did fieldwork on in California in 2000. This discourse is analyzed through the conceptual blend of the deceased victim 'testifying' through legal evidence. The emergence and argumentative power of this blend is examined vis à

  2. Balanced: a randomised trial examining the efficacy of two self-monitoring methods for an app-based multi-behaviour intervention to improve physical activity, sitting and sleep in adults.

    Science.gov (United States)

    Duncan, Mitch J; Vandelanotte, Corneel; Trost, Stewart G; Rebar, Amanda L; Rogers, Naomi; Burton, Nicola W; Murawski, Beatrice; Rayward, Anna; Fenton, Sasha; Brown, Wendy J

    2016-07-30

    Many adults are insufficiently physically active, have prolonged sedentary behaviour and report poor sleep. These behaviours can be improved by interventions that include education, goal setting, self-monitoring, and feedback strategies. Few interventions have explicitly targeted these behaviours simultaneously or examined the relative efficacy of different self-monitoring methods. This study aims to compare the efficacy of two self-monitoring methods in an app-based multi-behaviour intervention to improve objectively measured physical activity, sedentary, and sleep behaviours, in a 9 week 2-arm randomised trial. Participants will be adults (n = 64) who report being physically inactive, sitting >8 h/day and frequent insufficient sleep (≥14 days out of last 30). The "Balanced" intervention is delivered via a smartphone 'app', and includes education materials (guidelines, strategies to promote change in behaviour), goal setting, self-monitoring and feedback support. Participants will be randomly allocated to either a device-entered or user-entered self-monitoring method. The device-entered group will be provided with a activity tracker to self-monitor behaviours. The user-entered group will recall and manually record behaviours. Assessments will be conducted at 0, 3, 6, and 9 weeks. Physical activity, sedentary behaviour and sleep-wake behaviours will be measured using the wrist worn Geneactiv accelerometer. Linear mixed models will be used to examine differences between groups and over time using an alpha of 0.01. This study will evaluate an app-based multi-behavioural intervention to improve physical activity, sedentary behaviour and sleep; and the relative efficacy of two different approaches to self-monitoring these behaviours. Outcomes will provide information to inform future interventions and self-monitoring targeting these behaviours. ACTRN12615000182594 (Australian New Zealand Clinical Trials Registry. Registry URL: www.anzctr.org.au ; registered

  3. Internet-Based Cognitive Behavior Therapy for Procrastination: Study Protocol for a Randomized Controlled Trial

    Science.gov (United States)

    Rozental, Alexander

    2013-01-01

    period, albeit without therapist contact. Results The current study is believed to result in three important findings. First, a CBT intervention is assumed to be beneficial for people suffering from problems caused by procrastination. Second, the degree of therapist contact will have a positive effect on treatment outcome as procrastination can be partially explained as a self-regulatory failure. Third, an Internet based CBT intervention is presumed to be an effective way to administer treatment for procrastination, which is considered highly important, as the availability of adequate care is limited. The current study is therefore believed to render significant knowledge on the treatment of procrastination, as well as providing support for the use of Internet based CBT for difficulties due to delayed tasks and commitments. Conclusions To our knowledge, the current study is the first clinical trial to examine the effects of CBT for procrastination, and is assumed to render significant knowledge on the treatment of procrastination, as well as investigating whether it can be delivered via the Internet. Trial Registration ClinicalTrials.gov: NCT01842945; http://clinicaltrials.gov/show/NCT01842945 (Archived by WebCite at http://www.webcitation.org/6KSmaXewC). PMID:24220277

  4. An examination of the relationships between psychiatric disorders and traumatic brain injury: a prospective study

    OpenAIRE

    Gould, Kate Rachel

    2017-01-01

    Psychiatric disorders are commonly associated with traumatic brain injury (TBI). However, pre- and post-injury frequencies of disorders are variable, and their course, associated risk factors and relationship with psychosocial outcome are poorly understood due to methodological inconsistencies. No studies have prospectively examined the full range of Axis I psychiatric disorders using semi-structured clinical interview. Accordingly, the main aims of the current study were to (a) investigate t...

  5. What leads Indians to participate in clinical trials? A meta-analysis of qualitative studies.

    Directory of Open Access Journals (Sweden)

    Jatin Y Shah

    Full Text Available BACKGROUND: With the globalization of clinical trials, large developing nations have substantially increased their participation in multi-site studies. This participation has raised ethical concerns, among them the fear that local customs, habits and culture are not respected while asking potential participants to take part in study. This knowledge gap is particularly noticeable among Indian subjects, since despite the large number of participants, little is known regarding what factors affect their willingness to participate in clinical trials. METHODS: We conducted a meta-analysis of all studies evaluating the factors and barriers, from the perspective of potential Indian participants, contributing to their participation in clinical trials. We searched both international as well as Indian-specific bibliographic databases, including Pubmed, Cochrane, Openjgate, MedInd, Scirus and Medknow, also performing hand searches and communicating with authors to obtain additional references. We enrolled studies dealing exclusively with the participation of Indians in clinical trials. Data extraction was conducted by three researchers, with disagreement being resolved by consensus. RESULTS: Six qualitative studies and one survey were found evaluating the main themes affecting the participation of Indian subjects. Themes included Personal health benefits, Altruism, Trust in physicians, Source of extra income, Detailed knowledge, Methods for motivating participants as factors favoring, while Mistrust on trial organizations, Concerns about efficacy and safety of trials, Psychological reasons, Trial burden, Loss of confidentiality, Dependency issues, Language as the barriers. CONCLUSION: We identified factors that facilitated and barriers that have negative implications on trial participation decisions in Indian subjects. Due consideration and weightage should be assigned to these factors while planning future trials in India.

  6. A randomized trial examining the effects of Conjoint Behavioral Consultation in rural schools: Student outcomes and the mediating role of the teacher-parent relationship.

    Science.gov (United States)

    Sheridan, Susan M; Witte, Amanda L; Holmes, Shannon R; Coutts, Michael J; Dent, Amy L; Kunz, Gina M; Wu, ChaoRong

    2017-04-01

    The results of a large-scale randomized controlled trial of Conjoint Behavioral Consultation (CBC) on student outcomes and teacher-parent relationships in rural schools are presented. CBC is an indirect service delivery model that addresses concerns shared by teachers and parents about students. In the present study, the intervention was aimed at promoting positive school-related social-behavioral skills and strengthening teacher-parent relationships in rural schools. Participants were 267 students in grades K-3, their parents, and 152 teachers in 45 Midwest rural schools. Results revealed that, on average, improvement among students whose parents and teachers experienced CBC significantly outpaced that of control students in their teacher-reported school problems and observational measures of their inappropriate (off-task and motor activity) and appropriate (on-task and social interactions) classroom behavior. In addition, teacher responses indicated significantly different rates of improvement in their relationship with parents in favor of the CBC group. Finally, the teacher-parent relationship was found to partially mediate effects of CBC on several student outcomes. Unique contributions of this study, implications of findings for rural students, study limitations and suggestions for future research are discussed. Copyright © 2016 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

  7. Students' perceived stress and perception of barriers to effective study: impact on academic performance in examinations.

    Science.gov (United States)

    Turner, J; Bartlett, D; Andiappan, M; Cabot, L

    2015-11-13

    To identify students' perceptions of barriers to effective study and the relationship between these and demographic characteristics, levels of perceived stress and examination performance. A questionnaire was distributed to first (BDS1) and final year (BDS5) King's College London dental undergraduates, during Spring 2013. Data were collected on students' social and working environment using a Likert scale from zero to four. Levels of perceived stress and end-of-year examination results were collected. Statistical analyses were undertaken using SPSS® and Stata® software. A response rate of 83.0% (BDS1) and 82.9% (BDS5) was achieved. Social distractions were perceived to hinder study, with median scores of two and three for females and males respectively. The mean perceived stress score differed significantly (p=0.001) between males and females. Difficulties with journey was a significant predictor of perceived stress (p=0.03) as were family responsibilities (p=0.02). Social distractions were significantly related to examination performance (p=0.001). Social distractions were the barrier most highly rated as hindering effective study. Levels of perceived stress were high and were significantly associated with gender, a difficult journey to university and family responsibilities. Social distractions were significantly related to examination performance; students rating social distractions highly, performed less well.

  8. Implementing school nursing strategies to reduce LGBTQ adolescent suicide: a randomized cluster trial study protocol

    Directory of Open Access Journals (Sweden)

    Cathleen E. Willging

    2016-10-01

    Full Text Available Abstract Background Reducing youth suicide in the United States (U.S. is a national public health priority, and lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ youth are at elevated risk. The Centers for Disease Control and Prevention (CDC endorses six evidence-based (EB strategies that center on meeting the needs of LGBTQ youth in schools; however, fewer than 6 % of U.S. schools implement all of them. The proposed intervention model, “RLAS” (Implementing School Nursing Strategies to Reduce LGBTQ Adolescent Suicide, builds on the Exploration, Preparation, Implementation, and Sustainment (EPIS conceptual framework and the Dynamic Adaptation Process (DAP to implement EB strategies in U.S. high schools. The DAP accounts for the multilevel context of school settings and uses Implementation Resource Teams (IRTs to facilitate appropriate expertise, advise on acceptable adaptations, and provide data feedback to make schools implementation ready and prepared to sustain changes. Methods/Design Mixed methods will be used to examine individual, school, and community factors influencing both implementation process and youth outcomes. A cluster randomized controlled trial will assess whether LGBTQ students and their peers in RLAS intervention schools (n = 20 report reductions in suicidality, depression, substance use, bullying, and truancy related to safety concerns compared to those in usual care schools (n = 20. Implementation progress and fidelity for each EB strategy in RLAS intervention schools will be examined using a modified version of the Stages of Implementation Completion checklist. During the implementation and sustainment phases, annual focus groups will be conducted with the 20 IRTs to document their experiences identifying and advancing adaptation supports to facilitate use of EB strategies and their perceptions of the DAP. Discussion The DAP represents a data-informed, collaborative, multiple stakeholder

  9. Randomised Controlled Trial Study of the Effect of TENS and NSAID ...

    African Journals Online (AJOL)

    Randomised Controlled Trial Study of the Effect of TENS and NSAID (Opoid) Drug in the Management of Post Operative Gynaecological Pain. AAG Jimoh, LO Omokanye, GA Salaudeen, ZA Suleiman, K Durowade, EO Adewara ...

  10. Ultrasonographic findings in patients examined in cataract detection-andtreatment campaigns: a retrospective study

    Directory of Open Access Journals (Sweden)

    Marcio Henrique Mendes

    2009-01-01

    Full Text Available INTRODUCTION: A cataract is defined as an opacity of any portion of the lens, regardless of visual acuity. In some advanced cases of cataracts, in which good fundus visualization is not possible, an ultrasound examination provides better assessment of the posterior segment of the globe. OBJECTIVES: This study aims to evaluate the ultrasonographic records of patients with advanced cataracts who were examined during cataract campaigns. METHODS: The ultrasonographic findings obtained from 215 patients examined in cataract campaigns conducted by the Hospital das Clínicas Department of Ophthalmology of the Faculdade de Medicina da Universidade de São Paulo between the years of 2005 and 2007 were evaluated, and the utility of this exam in changing the treatment procedures was studied. RESULTS: A total of 289 eyes from 215 patients were examined. Of the eyes examined, 77.5% presented with findings in the vitreous cavity and the posterior pole. A posterior vitreous detachment with no other complications was observed in 47.4% of the eyes. The remaining 30.1% presented with eye diseases that could result in a reduced visual function after surgery. The most frequent eye diseases observed were diffuse vitreous opacity (12.1% of the eyes and detachment of the retina (9.3% of the eyes. DISCUSSION: In many cases, the ultrasonographic evaluation of the posterior segment revealed significant anomalies that changed the original treatment plan or contra-indicated surgery. At the very least, the evaluation was useful for patient counseling. CONCLUSION: The ultrasonographic examination revealed and differentiated between eyes with cataracts and eyes with ocular abnormalities other than cataracts as the cause of poor vision, thereby indicating the importance of its use during ocular evaluation.

  11. Sample Examination Questions. Grade 9 Social Studies, Asian and African Culture Studies.

    Science.gov (United States)

    New York State Education Dept., Albany. Bureau of Social Studies Education.

    Designed for a social studies program stressing the inquiry method, this packet of sample test questions uses a thematic rather that a topical approach. The four thematic categories are geography, religion and philosophy, cultural characteristics and relationships, and socialization. Four levels of the thinking process are identified and questions…

  12. Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8.

    Science.gov (United States)

    Ivers, N M; Taljaard, M; Dixon, S; Bennett, C; McRae, A; Taleban, J; Skea, Z; Brehaut, J C; Boruch, R F; Eccles, M P; Grimshaw, J M; Weijer, C; Zwarenstein, M; Donner, A

    2011-09-26

    To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are

  13. Multimodal MRI for early diabetic mild cognitive impairment: study protocol of a prospective diagnostic trial

    International Nuclear Information System (INIS)

    Yu, Ying; Sun, Qian; Yan, Lin-Feng; Hu, Yu-Chuan; Nan, Hai-Yan; Yang, Yang; Liu, Zhi-Cheng; Wang, Wen; Cui, Guang-Bin

    2016-01-01

    Type 2 diabetes mellitus (T2DM) is a risk factor for dementia. Mild cognitive impairment (MCI), an intermediary state between normal cognition and dementia, often occurs during the prodromal diabetic stage, making early diagnosis and intervention of MCI very important. Latest neuroimaging techniques revealed some underlying microstructure alterations for diabetic MCI, from certain aspects. But there still lacks an integrated multimodal MRI system to detect early neuroimaging changes in diabetic MCI patients. Thus, we intended to conduct a diagnostic trial using multimodal MRI techniques to detect early diabetic MCI that is determined by the Montreal Cognitive Assessment (MoCA). In this study, healthy controls, prodromal diabetes and diabetes subjects (53 subjects/group) aged 40-60 years will be recruited from the physical examination center of Tangdu Hospital. The neuroimaging and psychometric measurements will be repeated at a 0.5 year-interval for 2.5 years’ follow-up. The primary outcome measures are 1) Microstructural and functional alterations revealed with multimodal MRI scans including structure magnetic resonance imaging (sMRI), resting state functional magnetic resonance imaging (rs-fMRI), diffusion kurtosis imaging (DKI), and three-dimensional pseudo-continuous arterial spin labeling (3D-pCASL); 2) Cognition evaluation with MoCA. The second outcome measures are obesity, metabolic characteristics, lifestyle and quality of life. The study will provide evidence for the potential use of multimodal MRI techniques with psychometric evaluation in diagnosing MCI at prodromal diabetic stage so as to help decision making in early intervention and improve the prognosis of T2DM. This study has been registered to ClinicalTrials.gov (NCT02420470) on April 2, 2015 and published on July 29, 2015

  14. Overactive pelvic floor muscles (OPFM): improving diagnostic accuracy with clinical examination and functional studies.

    Science.gov (United States)

    Aw, Hau Choong; Ranasinghe, Weranja; Tan, Philip Huang Min; O'Connell, Helen E

    2017-07-01

    To identify the functional correlation of overactive pelvic floor muscles (OPFM) with cystoscopic and fluoroscopic urodynamic studies (FUDS), including urethral pressure measurements. Patients refractory to conservative therapy including bladder retraining, medications and pelvic muscle exercises for a variety of gamut of storage and voiding disorders were evaluated. Prospective data for 201 patients across both genders who underwent flexible cystoscopy and urodynamics for lower urinary tract symptoms (LUTS) refractory to conservative management between 01 Jan 2014 and 01 Jan 2016 was collected. Factors studied included history of LUTS, voiding patterns, physical examination, cystoscopic findings and functional studies, with maximum urethral closing pressure (MUCP). A total of 201 were patients recruited. The 85 were diagnosed with OPFM based on clinical presentation and presence of pelvic floor tenderness on examination. Significant differences were noted on functional studies with FUDS and urethral pressure measurement. Subjects with pelvic floor tenderness were found to have a higher (MUCP) at 93.1 cm H2O compared to 80.6 cm H2O (P=0.015). There are distinct characteristics of OPFM on clinical examination and functional studies, in particular MUCP. In patients refractory to conservative treatments, specific urodynamics tests are useful in sub-categorising patients. When OPFM is diagnosed, the impact on patient management is significant, and targeted intervention with pelvic floor physiotherapy is central in the multimodal approach of this complex condition.

  15. Randomised controlled trial of improvisational music therapy's effectiveness for children with autism spectrum disorders (TIME-A: study protocol

    Directory of Open Access Journals (Sweden)

    Geretsegger Monika

    2012-01-01

    Full Text Available Abstract Background Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication. However, generalisability of previous findings has been restricted, as studies were limited in either methodological accuracy or the clinical relevance of their approach. The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if variation in dose of treatment (i.e., number of music therapy sessions per week affects outcome of therapy, and to determine cost-effectiveness. Methods/Design Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions. Parents of all participants will receive three sessions of parent counselling (at 0, 2, and 5 months. In addition, children randomised to the two intervention groups will be offered individual, improvisational music therapy over a period of five months, either one session (low-intensity or three sessions (high-intensity per week. Generalised effects of music therapy will be measured using standardised scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS and parents (Social Responsiveness Scale, SRS before and 2, 5, and 12 months after randomisation. Cost effectiveness will be calculated as man years. A group sequential design with first interim look at N = 235 will ensure both power and efficiency. Discussion Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice. Addressing the issue of dose variation, this study's results will also provide information on the relevance of session

  16. Development and validation of filters for the retrieval of studies of clinical examination from Medline.

    Science.gov (United States)

    Shaikh, Nader; Badgett, Robert G; Pi, Mina; Wilczynski, Nancy L; McKibbon, K Ann; Ketchum, Andrea M; Haynes, R Brian

    2011-10-19

    Efficiently finding clinical examination studies--studies that quantify the value of symptoms and signs in the diagnosis of disease-is becoming increasingly difficult. Filters developed to retrieve studies of diagnosis from Medline lack specificity because they also retrieve large numbers of studies on the diagnostic value of imaging and laboratory tests. The objective was to develop filters for retrieving clinical examination studies from Medline. We developed filters in a training dataset and validated them in a testing database. We created the training database by hand searching 161 journals (n = 52,636 studies). We evaluated the recall and precision of 65 candidate single-term filters in identifying studies that reported the sensitivity and specificity of symptoms or signs in the training database. To identify best combinations of these search terms, we used recursive partitioning. The best-performing filters in the training database as well as 13 previously developed filters were evaluated in a testing database (n = 431,120 studies). We also examined the impact of examining reference lists of included articles on recall. In the training database, the single-term filters with the highest recall (95%) and the highest precision (8.4%) were diagnosis[subheading] and "medical history taking"[MeSH], respectively. The multiple-term filter developed using recursive partitioning (the RP filter) had a recall of 100% and a precision of 89% in the training database. In the testing database, the Haynes-2004-Sensitive filter (recall 98%, precision 0.13%) and the RP filter (recall 89%, precision 0.52%) showed the best performance. The recall of these two filters increased to 99% and 94% respectively with review of the reference lists of the included articles. Recursive partitioning appears to be a useful method of developing search filters. The empirical search filters proposed here can assist in the retrieval of clinical examination studies from Medline; however, because of

  17. A Randomized, Double-blind, Placebo-controlled Clinical Trial Examining the Effects of Green Tea Extract on Systemic Lupus Erythematosus Disease Activity and Quality of Life.

    Science.gov (United States)

    Shamekhi, Z; Amani, R; Habibagahi, Z; Namjoyan, F; Ghadiri, Ata; Saki Malehi, A

    2017-07-01

    Antiinflammatory and immunomodulatory benefit of green tea (Camellia sinensis) in autoimmune disease has been proven in recent studies. The objective of this study was to assess the effects of green tea on disease activity and quality of life in systemic lupus erythematosus patients. A randomized controlled trial on subjects with lupus was conducted, and 68 patients in the age range of 39.1 ± 10.3 years and body mass index of 25.7 ± 5.21 kg/m 2 completed the 12-week study. Patients were randomly divided into two groups of intervention (1000 mg green tea extract, two capsules/day) and control (1000 mg of starch, two capsules/day). Main outcome measure, systemic lupus erythematosus disease activity, was assessed by the systemic lupus erythematosus disease activity index at the first and after 3 months of intervention. In addition, patient's quality of life was evaluated by short form of quality-of-life questionnaire at baseline and after 3 months. Green tea extract supplementation significantly reduced disease activity in lupus patients (p tea extracts for 12 weeks improves the systemic lupus erythematosus disease activity as well as some aspects of quality of life. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  18. Examining the effect of peer helping in a coping skills intervention: a randomized controlled trial for advanced gastrointestinal cancer patients and their family caregivers.

    Science.gov (United States)

    Mosher, Catherine E; Secinti, Ekin; Johns, Shelley A; O'Neil, Bert H; Helft, Paul R; Shahda, Safi; Jalal, Shadia I; Champion, Victoria L

    2018-02-01

    At the end of life, spiritual well-being is a central aspect of quality of life for many patients and their family caregivers. A prevalent spiritual value in advanced cancer patients is the need to actively give. To address this need, the current randomized trial examined whether adding a peer helping component to a coping skills intervention leads to improved meaning in life and peace for advanced gastrointestinal cancer patients and their caregivers. Feasibility and acceptability outcomes were also assessed. Advanced gastrointestinal cancer patients and caregivers (n = 50 dyads) were randomly assigned to a 5-session, telephone-based coping skills intervention or a peer helping + coping skills intervention. One or both dyad members had moderate-severe distress. Peer helping involved contributing to handouts on coping skills for other families coping with cancer. Patients and caregivers completed measures of meaning in life/peace, fatigue, psychological symptoms, coping self-efficacy, and emotional support. Patient pain and caregiver burden were also assessed. Small effects in favor of the coping skills group were found regarding meaning in life/peace at 1 and 5 weeks post-intervention. Other outcomes did not vary as a function of group assignment, with both groups showing small decreases in patient and caregiver fatigue and caregiver distress and burden. High recruitment and retention rates supported feasibility, and high participant satisfaction ratings supported acceptability. Although a telephone-based intervention is feasible and acceptable for this population, peer helping in the context of a coping skills intervention does not enhance spiritual well-being relative to coping skills alone.

  19. Recent clinical trials in idiopathic pulmonary fibrosis and the BUILD-1 study

    Directory of Open Access Journals (Sweden)

    K. K. Brown

    2008-12-01

    Full Text Available Idiopathic pulmonary fibrosis (IPF, the most common of the interstitial pneumonias, is a progressive, life-limiting disease for which there are no truly effective therapies. In patients with biopsy-confirmed IPF, median survival is still <3 yrs. Although potent immunosuppressive therapy has underpinned the treatment of IPF in recent years and remains the standard of care, there is little quality evidence to support the efficacy and safety of traditional therapeutic strategies. This has spurred the search for new treatments for IPF and has led to a series of clinical trials of new therapies, seven of which are reviewed herein. They include the Bosentan Use in Interstitial Lung Disease (BUILD-1 trial, the results of which are discussed in detail, the European Idiopathic Pulmonary Fibrosis International Group Exploring N-acetylcysteine 1 Annual (IFIGENIA trial, the interferon gamma (GIPF-001 trial and the INSPIRE trial, as well as trials of anticoagulant therapy, pirfenidone and etanercept. Treatment trials in IPF are hindered by difficulties in achieving a secure diagnosis of IPF and the lack of validated outcome measures that represent either improvement or progression of disease. These and other limitations are discussed in the present article, as well as how some of these problems might be addressed in future trials. Although few of the seven studies met their primary end-points, marginal trends either on primary end-points or statistically significant trends on exploratory end-points were a recurrent theme in most trials. In the BUILD-1 trial, for example, a trend in favour of bosentan was observed on time-to-disease progression or death.

  20. A STUDY OF THE REQUIRED PUBLIC ACCOUNTING PROGRAM IN PUBLIC COMPETITIVE EXAMINATIONS HELD BY CESPE

    Directory of Open Access Journals (Sweden)

    Fátima de Souza Freire

    2012-11-01

    Full Text Available With a view to standardizing the contents offered to future Accounting professionals, the Federal Accounting Council (CFC elaborated the National Proposal for Undergraduate Accountancy Program Contents. Thus, the curriculum that Higher Education Institutions (HEI adopt serves as an ally for students’ professional conquests. Stability and favorable job conditions attract many people to the dispute for a public function, with a growing Braz ilian public competitive examination market. According to the National Association for Protection and Support to Public Competitive Examinations (Anpac, between 2003 and 2009, the number of public servants in the executive power with a higher education degree in Brazil increased by 26%. The aim of this study was to confront the CFC’s suggested knowledge with the contents required during tests applied in public competitive examinations for Accountancy professionals. The intent is to identify what Public Accounting knowledge is demanded from candidates for the public career. Through a documentary research, 561 calls from public competitive examinations exclusively for Accountancy professionals were selected for the study sample. They were classified according to the proposed program contents, the test questions by the Center for Selection and Event Promotion (Cespe, between 2000 and 2009. In conclusion, the most frequent required Public Accounting areas are contents related to Public Equity and Budget. The results demonstrate that the CFC’s suggested content is in line with the knowledge required from candidates for public functions.

  1. Factors influencing medical students' self-assessment of examination performance accuracy: A United Arab Emirates study.

    Science.gov (United States)

    Shaban, Sami; Aburawi, Elhadi H; Elzubeir, Khalifa; Elango, Sambandam; El-Zubeir, Margaret

    2016-01-01

    Assessment of one's academic capabilities is essential to being an effective, self-directed, life-long learner. The primary objective of this study was to analyze self-assessment accuracy of medical students attending the College of Medicine and Health Sciences, United Arab Emirates University, by examining their ability to assess their own performance on an MCQ examination. 1 st and 2 nd year medical students (n = 235) self-assessed pre and post-examination performance were compared with objectively measured scores (actual examination performance). Associations between accuracy of score prediction (pre and post assessment), and students' gender, year of education, perceived preparation, confidence and anxiety were also determined. Expected mark correlated significantly with objectively assessed marks (r = 0.407; P self-assessment accuracy. Findings reinforce existing evidence indicating that medical students are poor self-assessors. There are potentially multiple explanations for misjudgment of this multidimensional construct that require further investigation and change in learning cultures. The study offers clear targets for change aimed at optimizing self-assessment capabilities.

  2. Solving the issues in studying the soil cover at the institutions for plant varieties examination

    Directory of Open Access Journals (Sweden)

    В. М. Ткаченко

    2015-06-01

    Full Text Available Purpose. Considering ways to solve issues related to soil cover study at the institutions for plant varieties examination. Methods.Fieldandanalytical ones. Results. Issues are identified that arise during soil sampling at institutions for plant varieties examination within the state system of plant varieties protection. The author considered in detail the current soil sampling techniques for agrochemical tes­ting for humus, nitrogen (compounds to be easily hydrolyzed, mobile P2O5, exchangeable K2O, hydrolytic acidity and others. Attention was paid to violation of methodological requirements concerning the time of soil sampling and number of samples for agrochemical testing at the experimental field, to the lack of devices for meteorological observation and appliances for soil and leaf diagnostics. The article also touches upon the issues associated with the study of soil cover at fields with scientifically-based crop rotation that belong to institutions for plant varieties examination within the state system of plant varieties protection. Conclusions. It should be necessary to follow recommended practice when sampling at elementary sites for agrochemical testing and performing all operations in accordance with crop cultivation flowcharts. General recommendations for agrochemical testing of fields in case of conventional crop rotations in farms are not suitable for fields with scientifically-based crop rotations at institutions for plant varieties examination.

  3. Bronchial blocker versus left double-lumen endotracheal tube in video-assisted thoracoscopic surgery: a randomized-controlled trial examining time and quality of lung deflation.

    Science.gov (United States)

    Bussières, Jean S; Somma, Jacques; Del Castillo, José Luis Carrasco; Lemieux, Jérôme; Conti, Massimo; Ugalde, Paula A; Gagné, Nathalie; Lacasse, Yves

    2016-07-01

    Double-lumen endotracheal tubes (DL-ETT) and bronchial blockers (BB) have both been used for lung isolation in video-assisted thoracic surgery (VATS). Though not well studied, it is widely thought that a DL-ETT provides faster and better quality lung collapse. The aim of this study was to compare a BB technique vs a left-sided DL-ETT strategy with regard to the time and quality of lung collapse during one-lung ventilation (OLV) for elective VATS. Forty patients requiring OLV for VATS were randomized to receive a BB (n = 20) or a left-sided DL-ETT (n = 20). The primary endpoint was the time from pleural opening (performed by the surgeon) until complete lung collapse. The time was evaluated offline by reviewing video recorded during the VATS. The quality of lung deflation was also graded offline using a visual scale (1 = no lung collapse; 2 = partial lung collapse; and 3 = total lung collapse) and was recorded at several time points after pleural incision. The surgeon also graded the time to complete lung collapse and quality of lung deflation during the procedure. The surgeon's guess as to which device was used for lung isolation was also recorded. Of the 40 patients enrolled in the study, 20 patients in the DL-ETT group and 18 in the BB group were analyzed. There mean (standard deviation) time to complete lung collapse of the operative lung was significantly faster using the BB compared with using the DL-ETT [7.5 (3.8) min vs 36.6 (29.1) min, respectively; mean difference, 29.1 min; 95% confidence interval, 1.8 to 7.2; P < 0.001]. Overall, a higher proportion of patients in the BB group than in the DL-ETT group achieved a quality of lung collapse score of 3 at five minutes (57% vs 6%, respectively; P < 0.004), ten minutes (73% vs 14%, respectively; P = 0.005), and 20 min (100% vs 25%, respectively; P = 0.002) after opening the pleura. The surgeon incorrectly guessed the type of device used in 78% of the BB group and 50% of the DL-ETT group (P = 0.10). The time and

  4. Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

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    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

  5. Secure E-Examination Systems Compared: Case Studies from Two Countries

    Directory of Open Access Journals (Sweden)

    Andrew E. Fluck

    2017-04-01

    Full Text Available Aim/Purpose: Electronic examinations have some inherent problems. Students have expressed negative opinions about electronic examinations (e-examinations due to a fear of, or unfamiliarity with, the technology of assessment, and a lack of knowledge about the methods of e-examinations. Background: Electronic examinations are now a viable alternative method of assessing student learning. They provide freedom of choice, in terms of the location of the examination, and can provide immediate feedback; students and institutions can be assured of the integrity of knowledge testing. This in turn motivates students to strive for deeper learning and better results, in a higher quality and more rigorous educational process. Methodology\t: This paper compares an e-examination system at FUT Minna Nigeria with one in Australia, at the University of Tasmania, using case study analysis. The functions supported, or inhibited, by each of the two e-examination systems, with different approaches to question types, cohort size, technology used, and security features, are compared. Contribution: The researchers’ aim is to assist stakeholders (including lecturers, invigilators, candidates, computer instructors, and server operators to identify ways of improving the process. The relative convenience for students, administrators, and lecturer/assessors and the reliability and security of the two systems are considered. Challenges in conducting e-examinations in both countries are revealed by juxtaposing the systems. The authors propose ways of developing more effective e-examination systems. Findings: The comparison of the two institutions in Nigeria and Australia shows e-examinations have been implemented for the purpose of selecting students for university courses, and for their assessment once enrolled. In Nigeria, there is widespread systemic adoption for university entrance merit selection. In Australia this has been limited to one subject in one state, rather

  6. Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials.

    Science.gov (United States)

    Sarwar, Chaudhry M S; Vaduganathan, Muthiah; Butler, Javed

    2017-08-01

    There are over 25 million patients living with heart failure globally. Overall, and especially post-discharge, clinical outcomes have remained poor in heart failure despite multiple trials, with both successes and failures over the last two decades. Matching therapies to the right patient population, identifying high-quality sites, and ensuring optimal trial design and execution represent important considerations in the development of novel therapeutics in this space. While clinical trials have undergone rapid globalization, this has come with regional variation in comorbidities, clinical parameters, and even clinical outcomes and treatment effects across international sites. These issues have now highlighted knowledge gaps about the conduct of trials, selection of study sites, and an unmet need to develop and identify "ideal" sites. There is a need for all stakeholders, including academia, investigators, healthcare organizations, patient advocacy groups, industry sponsors, research organizations, and regulatory authorities, to work as a multidisciplinary group to address these problems and develop practical solutions to improve trial conduct, efficiency, and execution. We review these trial-level issues using examples from contemporary studies to inform and optimize the design of future global clinical trials in heart failure.

  7. A case study evaluation of ethics review systems for multicentre clinical trials.

    Science.gov (United States)

    Hicks, Sian C; James, Rebecca E; Wong, Nicole; Tebbutt, Niall C; Wilson, Kate

    2009-09-07

    To evaluate the difference in time taken for ethics and site governance approval for multicentre clinical trials using two different systems of ethics review. We evaluated the times to final ethics and governance approval for two international, multicentre clinical trials of treatment for metastatic colorectal cancer: the MAX trial, using a non-centralised ethics review system, and the CO.20 trial, using the new New South Wales centralised ethics review system. Time from trial submission to overall study approval. The median time taken to obtain ethics approval for the MAX trial at 16 NSW sites was 100 days (range, 36-161 days). The median time to obtain central ethics approval for the CO.20 trial at 14 NSW sites was 77 days, with an additional 60 days (range 20-79 days) required to obtain site-specific research governance approval. Any difference in time to approval between the review systems was outweighed by the overall time taken. However, the time spent by both the coordinating centre and local sites in collation, submission and correspondence was greatly reduced, and the centralised process allowed for standardised documentation at all study sites.

  8. Balanced: a randomised trial examining the efficacy of two self-monitoring methods for an app-based multi-behaviour intervention to improve physical activity, sitting and sleep in adults

    Directory of Open Access Journals (Sweden)

    Mitch J. Duncan

    2016-07-01

    Full Text Available Abstract Background Many adults are insufficiently physically active, have prolonged sedentary behaviour and report poor sleep. These behaviours can be improved by interventions that include education, goal setting, self-monitoring, and feedback strategies. Few interventions have explicitly targeted these behaviours simultaneously or examined the relative efficacy of different self-monitoring methods. Methods/Design This study aims to compare the efficacy of two self-monitoring methods in an app-based multi-behaviour intervention to improve objectively measured physical activity, sedentary, and sleep behaviours, in a 9 week 2–arm randomised trial. Participants will be adults (n = 64 who report being physically inactive, sitting >8 h/day and frequent insufficient sleep (≥14 days out of last 30. The “Balanced” intervention is delivered via a smartphone ‘app’, and includes education materials (guidelines, strategies to promote change in behaviour, goal setting, self-monitoring and feedback support. Participants will be randomly allocated to either a device-entered or user-entered self-monitoring method. The device-entered group will be provided with a activity tracker to self-monitor behaviours. The user-entered group will recall and manually record behaviours. Assessments will be conducted at 0, 3, 6, and 9 weeks. Physical activity, sedentary behaviour and sleep-wake behaviours will be measured using the wrist worn Geneactiv accelerometer. Linear mixed models will be used to examine differences between groups and over time using an alpha of 0.01. Discussion This study will evaluate an app-based multi-behavioural intervention to improve physical activity, sedentary behaviour and sleep; and the relative efficacy of two different approaches to self-monitoring these behaviours. Outcomes will provide information to inform future interventions and self-monitoring targeting these behaviours. Trial registration ACTRN12615000182594

  9. PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Cameron, Jan; Rendell, Peter G; Ski, Chantal F; Kure, Christina E; McLennan, Skye N; Rose, Nathan S; Prior, David L; Thompson, David R

    2015-04-29

    Cognitive impairment is seen in up to three quarters of heart failure (HF) patients and has a significant negative impact on patients' health outcomes. Prospective memory, which is defined as memory to carry out future intentions, is important for functional independence in older adults and involves application of multiple cognitive processes that are often impaired in HF patients. The objective of this study is to examine the effects of prospective memory training on patients' engagement in HF self-care and health outcomes, carer strain and quality of life. The proposed study is a randomised, controlled trial in which 200 patients diagnosed with HF, and their carers will be recruited from 3 major hospitals across Melbourne. Eligible patients with HF will be randomised to receive either: 1) The Virtual Week Training Program - a computerised prospective memory (PM) training program (intervention) or 2) non-adaptive computer-based word puzzles (active control). HF patients' baseline cognitive function will be compared to a healthy control group (n = 60) living independently in the community. Patients will undergo a comprehensive assessment of PM, neuropsychological functioning, self-care, physical, and emotional functioning. Assessments will take place at baseline, 4 weeks and 12 months following intervention. Carers will complete measures assessing quality of life, strain, perceived control in the management of the patients' HF symptoms, and ratings of the patients' level of engagement in HF self-care behaviours. If the Virtual Week Training Program is effective in improving: 1) prospective memory; 2) self-care behaviours, and 3) wellbeing in HF patients, this study will enhance our understanding of impaired cognitive processes in HF and potentially is a mechanism to reduce healthcare costs. Australian New Zealand Clinical Trials Registry #366376; 27 May 2014. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366376&isClinicalTrial=False .

  10. Do health care institutions value research? A mixed methods study of barriers and facilitators to methodological rigor in pediatric randomized trials.

    Science.gov (United States)

    Hamm, Michele P; Scott, Shannon D; Klassen, Terry P; Moher, David; Hartling, Lisa

    2012-10-18

    Pediatric randomized controlled trials (RCTs) are susceptible to a high risk of bias. We examined the barriers and facilitators that pediatric trialists face in the design and conduct of unbiased trials. We used a mixed methods design, with semi-structured interviews building upon the results of a quantitative survey. We surveyed Canadian (n=253) and international (n=600) pediatric trialists regarding their knowledge and awareness of bias and their perceived barriers and facilitators in conducting clinical trials. We then interviewed 13 participants from different subspecialties and geographic locations to gain a more detailed description of how their experiences and attitudes towards research interacted with trial design and conduct. The survey response rate was 23.0% (186/807). 68.1% of respondents agreed that bias is a problem in pediatric RCTs and 72.0% felt that there is sufficient evidence to support changing some aspects of how trials are conducted. Knowledge related to bias was variable, with inconsistent awareness of study design features that may introduce bias into a study. Interview participants highlighted a lack of formal training in research methods, a negative research culture, and the pragmatics of trial conduct as barriers. Facilitators included contact with knowledgeable and supportive colleagues and infrastructure for research. A lack of awareness of bias and negative attitudes towards research present significant barriers in terms of conducting methodologically rigorous pediatric RCTs. Knowledge translation efforts must focus on these issues to ensure the relevance and validity of trial results.

  11. The representativeness of eligible patients in type 2 diabetes trials: a case study using GIST 2.0.

    Science.gov (United States)

    Sen, Anando; Goldstein, Andrew; Chakrabarti, Shreya; Shang, Ning; Kang, Tian; Yaman, Anil; Ryan, Patrick B; Weng, Chunhua

    2017-09-13

    The population representativeness of a clinical study is influenced by how real-world patients qualify for the study. We analyze the representativeness of eligible patients for multiple type 2 diabetes trials and the relationship between representativeness and other trial characteristics. Sixty-nine study traits available in the electronic health record data for 2034 patients with type 2 diabetes were used to profile the target patients for type 2 diabetes trials. A set of 1691 type 2 diabetes trials was identified from ClinicalTrials.gov, and their population representativeness was calculated using the published Generalizability Index of Study Traits 2.0 metric. The relationships between population representativeness and number of traits and between trial duration and trial metadata were statistically analyzed. A focused analysis with only phase 2 and 3 interventional trials was also conducted. A total of 869 of 1691 trials (51.4%) and 412 of 776 phase 2 and 3 interventional trials (53.1%) had a population representativeness of representativeness was significantly correlated with the representativeness of the Hba1c criterion. The greater the number of criteria or the shorter the trial, the less the representativeness. Among the trial metadata, phase, recruitment status, and start year were found to have a statistically significant effect on population representativeness. For phase 2 and 3 interventional trials, only start year was significantly associated with representativeness. Our study quantified the representativeness of multiple type 2 diabetes trials. The common low representativeness of type 2 diabetes trials could be attributed to specific study design requirements of trials or safety concerns. Rather than criticizing the low representativeness, we contribute a method for increasing the transparency of the representativeness of clinical trials. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics

  12. What are the health benefits of active travel? A systematic review of trials and cohort studies.

    Directory of Open Access Journals (Sweden)

    Lucinda E Saunders

    Full Text Available BACKGROUND: Increasing active travel (primarily walking and cycling has been widely advocated for reducing obesity levels and achieving other population health benefits. However, the strength of evidence underpinning this strategy is unclear. This study aimed to assess the evidence that active travel has significant health benefits. METHODS: The study design was a systematic review of (i non-randomised and randomised controlled trials, and (ii prospective observational studies examining either (a the effects of interventions to promote active travel or (b the association between active travel and health outcomes. Reports of studies were identified by searching 11 electronic databases, websites, reference lists and papers identified by experts in the field. Prospective observational and intervention studies measuring any health outcome of active travel in the general population were included. Studies of patient groups were excluded. RESULTS: Twenty-four studies from 12 countries were included, of which six were studies conducted with children. Five studies evaluated active travel interventions. Nineteen were prospective cohort studies which did not evaluate the impact of a specific intervention. No studies were identified with obesity as an outcome in adults; one of five prospective cohort studies in children found an association between obesity and active travel. Small positive effects on other health outcomes were found in five intervention studies, but these were all at risk of selection bias. Modest benefits for other health outcomes were identified in five prospective studies. There is suggestive evidence that active travel may have a positive effect on diabetes prevention, which may be an important area for future research. CONCLUSIONS: Active travel may have positive effects on health outcomes, but there is little robust evidence to date of the effectiveness of active transport interventions for reducing obesity. Future evaluations of such

  13. A pilot study on the quality of data management in a cancer clinical trial

    OpenAIRE

    Putten, E. van der; Velden, J.W. van der; Siers, A.; Hamersma, E.A.M.

    1987-01-01

    Twelve institutional data managers were asked to independently code the data from a patient chart of one patient in an ovarian cancer trial. They abstracted data from the medical record and filled out three types of trial forms (on-study, chemotherapy, and summary forms). The analysis of the processed data revealed that the median rate of errors was 13% for the 12 data managers. The error rate differed among the types of trial forms. The factors causing these errors were mistakes in interpret...

  14. Supervised progressive cross-continuum strength training compared with usual care in older medical patients: study protocol for a randomized controlled trial (the STAND-Cph trial).

    Science.gov (United States)

    Pedersen, Mette Merete; Petersen, Janne; Beyer, Nina; Damkjær, Lars; Bandholm, Thomas

    2016-04-01

    Hospitalization in older adults is characterized by physical inactivity and a risk of losing function and independence. Systematic strength training can improve muscle strength and functional performance in older adults. Few studies have examined the effect of a program initiated during hospitalization and continued after discharge. We conducted a feasibility study prior to this trial and found a progression model for loaded sit-to-stands feasible in older medical patients. This study aims to determine whether a simple supervised strength training program for the lower extremities (based on the model), combined with post-training protein supplementation initiated during hospitalization and continued at home for 4 weeks, is superior to usual care on change in mobility 4 weeks after discharge in older medical patients. Eighty older medical patients (65 years or older) acutely admitted from their own homes will be included in this randomized, controlled, parallel-group, investigator-blinded, superiority trial. After baseline assessments patients will be randomized to (1) intervention: progressive strength training during hospitalization and after discharge (home-based), or (2) control: usual care. Shortly after discharge, 4 weeks after discharge (primary end point) and 6 months after discharge patients will be assessed in their own homes. The intervention encompasses strength training consisting of two lower extremity exercises (sit-to-stand and heel raise) daily during hospitalization and three times per week for 4 weeks after discharge. Both exercises follow pre-defined models for progression and will be performed for three sets of 8-12 repetitions maximum in each training session. Thereafter, the patient will be asked to consume a protein supplement given orally containing 18 g milk-based protein. The primary outcome will be change in the de Morton Mobility Index score from baseline to 4 weeks after discharge. Secondary outcomes will be 24-h mobility level

  15. Identifying additional studies for a systematic review of retention strategies in randomised controlled trials: making contact with trials units and trial methodologists.

    Science.gov (United States)

    Brueton, Valerie; Tierney, Jayne F; Stenning, Sally; Rait, Greta

    2017-08-22

    Search strategies for systematic reviews aim to identify all evidence relevant to the research question posed. Reports of methodological research can be difficult to find leading to biased results in systematic reviews of research methodology. Evidence suggests that contact with investigators can help to identify unpublished research. To identify additional eligible randomised controlled trials (RCTs) for a Cochrane systematic review of strategies to improve retention in RCTs, we conducted a survey of UK clinical trials units (CTUs) and made contact with RCT methodologists. Key contacts for all UK CTUs were sent a personalised email with a short questionnaire and summary protocol of the Cochrane methodology review. The questionnaire asked whether a RCT evaluating strategies to improve retention embedded in a RCT had ever been conducted by the CTU. Questions about the stage of completion and publication of such RCTs were included. The summary protocol outlined the aims, eligibility criteria, examples of types of retention strategies, and the primary outcome for the systematic review. Personal communication with RCT methodologists and presentations of preliminary results of the review at conferences were also used to identify additional eligible RCTs. We checked the results of our standard searches to see if eligible studies identified through these additional methods were also found using our standard searches. We identified 14 of the 38 RCTs included in the Cochrane methodology review by contacting trials units and methodologists. Eleven of the 14 RCTs identified by these methods were either published in grey literature, in press or unpublished. Three remaining RCTs were fully published at the time. Six of the RCTs identified were not found through any other searches. The RCTs identified represented data for 6 of 14 RCTs of incentive strategies (52% of randomised participants included in the review), and 6 of 14 RCTs of communication strategies (52% of randomised

  16. Motivations and concerns about adolescent tuberculosis vaccine trial participation in rural Uganda: a qualitative study.

    Science.gov (United States)

    Buregyeya, Esther; Kulane, Asli; Kiguli, Juliet; Musoke, Phillipa; Mayanja, Harriet; Mitchell, Ellen Maeve Hanlon

    2015-01-01

    Research is being carried out to develop and test new potentially more effective tuberculosis vaccines. Among the vaccines being developed are those that target adolescents. This study explored the stakeholders' perceptions about adolescent participation in a hypothetical tuberculosis vaccine trial in Ugandan adolescents. Focus group discussions with adolescents, parents of infants and adolescents, and key informant interviews with community leaders and traditional healers were conducted. The majority of the respondents expressed potential willingness to allow their children participate in a tuberculosis vaccine trial. Main motivations for potential participation would be being able to learn about health-related issues. Hesitations included the notion that trial participation would distract the youths from their studies, fear of possible side effects of an investigational product, and potential for being sexually exploited by researchers. In addition, bad experiences from participation in previous research and doubts about the importance of research were mentioned. Suggested ways to motivate participation included: improved clarity on study purpose, risks, benefits and better scheduling of study procedures to minimize disruption to participants' academic schedules. Findings from this study suggest that the community is open to potential participation of adolescents in a tuberculosis vaccine trial. However, there is a need to communicate more effectively with the community about the purpose of the trial and its effects, including safety data, in a low-literacy, readily understood format. This raises a challenge to researchers, who cannot know all the potential effects of a trial product before it is tested.

  17. Examining the Reproducibility of 6 Published Studies in Public Health Services and Systems Research.

    Science.gov (United States)

    Harris, Jenine K; B Wondmeneh, Sarah; Zhao, Yiqiang; Leider, Jonathon P

    2018-02-23

    Research replication, or repeating a study de novo, is the scientific standard for building evidence and identifying spurious results. While replication is ideal, it is often expensive and time consuming. Reproducibility, or reanalysis of data to verify published findings, is one proposed minimum alternative standard. While a lack of research reproducibility has been identified as a serious and prevalent problem in biomedical research and a few other fields, little work has been done to examine the reproducibility of public health research. We examined reproducibility in 6 studies from the public health services and systems research subfield of public health research. Following the methods described in each of the 6 papers, we computed the descriptive and inferential statistics for each study. We compared our results with the original study results and examined the percentage differences in descriptive statistics and differences in effect size, significance, and precision of inferential statistics. All project work was completed in 2017. We found consistency between original and reproduced results for each paper in at least 1 of the 4 areas examined. However, we also found some inconsistency. We identified incorrect transcription of results and omitting detail about data management and analyses as the primary contributors to the inconsistencies. Increasing reproducibility, or reanalysis of data to verify published results, can improve the quality of science. Researchers, journals, employers, and funders can all play a role in improving the reproducibility of science through several strategies including publishing data and statistical code, using guidelines to write clear and complete methods sections, conducting reproducibility reviews, and incentivizing reproducible science.

  18. Upper gastrointestinal examinations: a radiographic study of clinically normal Beagle puppies

    International Nuclear Information System (INIS)

    Miyabayashi, T.; Morgan, J.P.

    1991-01-01

    A total of 24 upper gastrointestinal examinations were performed on four weanling beagle puppies over six weeks, using liquid barium (10 ml/kg body weight of 60 per cent w/v barium sulphate suspension] and barium food (8 g/kg of crushed kibble dog food and 7 ml/kg body weight of 60 per cent w/v barium sulphate suspension) as contrast media. The radiographic appearance was similar to that noted in adult dogs except for the consistent location of the pylorus on or near the midline. Duodenal pseudoulcers were seen more often with liquid barium and the caecal shadows were identified more often with the longer examination time with barium food. The stomach of the puppies appeared to have discriminatory emptying function; that is, semi-solid food was emptied from the stomach at a slower rate (210 to 450 minutes) than liquid (60 to 90 minutes). Solid meals emptied faster in puppies than in adult dogs. Dosages of 13 to 15 mg/kg body weight for the liquid barium examination and 14 g of ground kibble and 16 ml of barium sulphate suspension per m2 of body surface area for the barium food examination are suggested as more appropriate for contrast studies in puppies

  19. The application of teleophthalmology in examining patients with glaucoma: a pilot study.

    Science.gov (United States)

    Tuulonen, A; Ohinmaa, T; Alanko, H I; Hyytinen, P; Juutinen, A; Toppinen, E

    1999-12-01

    To test the feasibility of teleophthalmology applications in examining patients with glaucoma, test its use for training purposes in an ophthalmology residency program and as a consultation link between primary healthcare unit and university eye clinic, and to introduce a preliminary model for economic assessment of telemedicine application in ophthalmology. A video slit-lamp, an automated perimeter, a nonmydriatic fundus camera and a videoconferencing system were installed in a healthcare center in a rural area. Twenty-nine patients with glaucoma were examined in the rural healthcare center instead of the university eye clinic. A control group consisted of 41 glaucoma patients examined at the eye clinic one year earlier. An ophthalmic resident examined the patients together with the local general practitioner. An interactive video consultation was created with the university glaucoma clinic using ISDN connections and special application software. Both patient groups were equally satisfied with the ophthalmic service. Nearly all patients in the telemedicine group (96%) wanted to have their next visit in their own healthcare center instead of the university clinic. The most important reasons were reduction in traveling (97%), costs (92%), and time (92%). The costs of the telemedicine and conventional visits were equal, but decreased traveling saved $55 per visit. However, the quality of the images obtained in the remote center was poorer than that of the images obtained at the university clinic. The results of this pilot study indicate that further research with a larger number of patients is warranted to evaluate both methods, technology, and economics of teleophthalmology.

  20. The Effects of Music during a Physical Examination Skills Practice: A Pilot Study.

    Science.gov (United States)

    Artemiou, Elpida; Gilbert, Gregory E; Sithole, Fortune; Koster, Liza S

    2017-09-27

    Some veterinary students experience elevated stress, anxiety, and depression resulting in disease and psychological changes. Elevated arousal, negative moods, and lack of interest can negatively affect performance and learning. Psychoacoustic music promotes calming effects using simple and slow piano sounds and can positively impact well-being and functioning. This pilot study assessed the effects of music on blood pressure, pulse, arousal, and mood during a canine physical examination laboratory. In an AB/BA crossover study, 17 students were randomly allocated to practice physical examination skills while listening to Through a Dog's Ear, Volume 1 . Psychological and physiologic data were collected. Nonparametric methods were used to test for significant differences in psychological and physiologic data and a linear mixed models approach was used to test for physiological differences. There were no significant baseline differences between the music and no music groups for DASS-21 depression, anxiety, or stress scores; however, there were significant time differences between pretest and posttest on arousal and mood as measured by the Profile of Mood Sates (POMS) Depression, Fatigue-Inertia, and Tension Anxiety subscales. Linear mixed models revealed no significant treatment effect on the pulse and diastolic blood pressure; however, there was a significant systolic blood pressure treatment effect. Future indications include repeating the study with a larger sample to examine longitudinal psychological and physiological benefits.

  1. The Effects of Music during a Physical Examination Skills Practice: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Elpida Artemiou

    2017-09-01

    Full Text Available Some veterinary students experience elevated stress, anxiety, and depression resulting in disease and psychological changes. Elevated arousal, negative moods, and lack of interest can negatively affect performance and learning. Psychoacoustic music promotes calming effects using simple and slow piano sounds and can positively impact well-being and functioning. This pilot study assessed the effects of music on blood pressure, pulse, arousal, and mood during a canine physical examination laboratory. In an AB/BA crossover study, 17 students were randomly allocated to practice physical examination skills while listening to Through a Dog’s Ear, Volume 1. Psychological and physiologic data were collected. Nonparametric methods were used to test for significant differences in psychological and physiologic data and a linear mixed models approach was used to test for physiological differences. There were no significant baseline differences between the music and no music groups for DASS-21 depression, anxiety, or stress scores; however, there were significant time differences between pretest and posttest on arousal and mood as measured by the Profile of Mood Sates (POMS Depression, Fatigue–Inertia, and Tension Anxiety subscales. Linear mixed models revealed no significant treatment effect on the pulse and diastolic blood pressure; however, there was a significant systolic blood pressure treatment effect. Future indications include repeating the study with a larger sample to examine longitudinal psychological and physiological benefits.

  2. Dysphagia in Lewy body dementia - a clinical observational study of swallowing function by videofluoroscopic examination.

    Science.gov (United States)

    Londos, Elisabet; Hanxsson, Oskar; Alm Hirsch, Ingrid; Janneskog, Anna; Bülow, Margareta; Palmqvist, Sebastian

    2013-10-07

    Dysphagia, which can result in aspiration pneumonia and death, is a well-known problem in patients with dementia and Parkinson's disease. There are few studies on dysphagia in patients with dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD), especially studies objectively documenting the type of swallowing dysfunction. The aim of this study was therefore to investigate the prevalence, and define the actual swallowing dysfunction according to a videofluoroscopic swallowing examination (VFSE) in patients with DLB and PDD. Eighty-two consecutive patients with DLB or PDD in a clinical follow-up program were asked about symptoms of dysphagia. Those experiencing dysphagia were examined with VFSE. Prevalence and type of swallowing dysfunction was recorded. Twenty-six patients (32%) reported symptoms of dysphagia such as swallowing difficulties or coughing. Twenty-four (92%) of these had a documented swallowing dysfunction on VFSE. Eighty-eight percent suffered from pharyngeal dysfunction. Almost all DLB or PDD patients with subjective signs of dysphagia had pathologic results on VFSE, the majority of pharyngeal type. This type of dysphagia has not been reported in DLB before. The results have clinical implications and highlight the importance of asking for and examining swallowing function to prevent complications such as aspiration.

  3. Extension Trial of Qigong for Fibromyalgia: A Quantitative and Qualitative Study

    Directory of Open Access Journals (Sweden)

    Jana Sawynok

    2013-01-01

    Full Text Available This extension trial is an open-label observational trial of 20 subjects with fibromyalgia who undertook level 2 Chaoyi Fanhuan Qigong (CFQ training following an earlier controlled trial of level 1 CFQ. Subjects practiced 60 min/day for 8 weeks and continued some daily practice for 6 months. Quantitative measures, assessed at baseline, 8 weeks, 4 and 6 months, were of pain, impact, sleep, physical and mental functions, and practice time. Qualitative comments also were recorded. Compared to baselines, CFQ practice led to significant improvements in pain, impact, sleep, and physical function in the 13 subjects (65% who completed the trial; changes were present at 8 weeks and were maintained for the 6-month trial duration. A highly motivated subgroup of N=5, who practiced the most, had the best outcomes in terms of end symptomology, and qualitative comments indicated health benefits in other domains as well. Qualitative comments by the remaining N=8 trial completers and N=7 withdrawals indicate different experiences with the practice. This extension trial indicates that diligent CFQ practice over time produces significant health gains in fibromyalgia in a subset of individuals. Future studies will need to address factors that might predispose to favourable outcomes.

  4. Extension trial of qigong for fibromyalgia: a quantitative and qualitative study.

    Science.gov (United States)

    Sawynok, Jana; Lynch, Mary; Marcon, Dana

    2013-01-01

    This extension trial is an open-label observational trial of 20 subjects with fibromyalgia who undertook level 2 Chaoyi Fanhuan Qigong (CFQ) training following an earlier controlled trial of level 1 CFQ. Subjects practiced 60 min/day for 8 weeks and continued some daily practice for 6 months. Quantitative measures, assessed at baseline, 8 weeks, 4 and 6 months, were of pain, impact, sleep, physical and mental functions, and practice time. Qualitative comments also were recorded. Compared to baselines, CFQ practice led to significant improvements in pain, impact, sleep, and physical function in the 13 subjects (65%) who completed the trial; changes were present at 8 weeks and were maintained for the 6-month trial duration. A highly motivated subgroup of N = 5, who practiced the most, had the best outcomes in terms of end symptomology, and qualitative comments indicated health benefits in other domains as well. Qualitative comments by the remaining N = 8 trial completers and N = 7 withdrawals indicate different experiences with the practice. This extension trial indicates that diligent CFQ practice over time produces significant health gains in fibromyalgia in a subset of individuals. Future studies will need to address factors that might predispose to favourable outcomes.

  5. The efficacy and safety of acupuncture for cerebral vasospasm after subarachnoid hemorrhage: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cho, Seung-Yeon; Lee, Dong-Hyuk; Shin, Hee Sup; Lee, Seung Hwan; Koh, Jun Seok; Jung, Woo-Sang; Moon, Sang-Kwan; Park, Jung-Mi; Ko, Chang-Nam; Kim, Ho; Park, Seong-Uk

    2015-02-28

    Subarachnoid hemorrhage (SAH) is a neurological disease with a high mortality rate. Several serious complications frequently arise after successful surgery for this condition. Cerebral vasospasm, one such complication, occurs in 50 to 70% of SAH patients. These patients suffer neurological symptoms known as delayed ischemic neurological deficit (DIND); however, the effect of treatment of vasospasm is limited. The major pathogenesis of cerebral vasospasm is the reduction of nitric oxide (NO) and activation of vasoconstrictors. Acupuncture is known to increase the production and activity of vascular endothelial cell-derived NO and improve endothelium-dependent vasodilatation. A preliminary retrospective case study to investigate the ability of acupuncture to prevent the occurrence of cerebral vasospasm has been conducted. However, no randomized, controlled clinical trials have been carried out to evaluate the efficacy of acupuncture for cerebral vasospasm. This trial will be a single-center, randomized, placebo-controlled, parallel group, patient-assessor-blinded clinical trial. A total of 80 patients with SAH will be randomized into two groups: a study group given acupuncture, electroacupuncture, and intradermal acupuncture, and a control group given mock transcutaneous electrical nerve stimulation and sham intradermal acupuncture. Intervention will start within 96 h after SAH, and a total of 12 sessions will be performed during a 2-week period. The primary outcome measure will be the occurrence of DIND, and the secondary outcomes will be vasospasm as measured by cerebral angiography, transcranial Doppler, clinical symptoms, vasospasm-related infarcts, NO and endothelin-1 plasma levels, mortality, and modified Rankin Scale scores. This trial will examine the efficacy and safety of acupuncture for cerebral vasospasm after SAH. The placebo effect will be excluded and the mechanism of action of the treatments will be evaluated through blood testing. ClinicalTrials

  6. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ...

  7. Clinical Trials

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    Full Text Available ... best data available for health care decisionmaking. The purpose of clinical trials is research, so the studies ... Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients ...

  8. Clinical Trials

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    Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

  9. Clinical Trials

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    Full Text Available ... Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants & ... or groups to help sponsor some trials. All types of clinical trials contribute to medical knowledge and ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... are research studies that explore whether a medical strategy, treatment, or device is safe and effective for ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ... that does the study uses the same protocol. Key information in a protocol includes how many patients ...

  12. Published intimate partner violence studies often differ from their trial registration records.

    Science.gov (United States)

    Madden, Kim; Tai, Kerry; Ali, Zak; Schneider, Patricia; Singh, Mahip; Ghert, Michelle; Bhandari, Mohit

    2017-12-27

    Registering study protocols in a trial registry is important for methodologic transparency and reducing selective reporting bias. The objective of this investigation was to determine whether published studies of intimate partner violence (IPV) that had been registered matched the registration record on key study design elements. We systematically searched three trial registries to identify registered IPV studies and the published literature for the associated publication. Two authors independently determined for each study whether key study elements in the registry matched those in the published paper. We included 66 studies published between 2006 and 2017. Nearly half (29/66, 44%) were registered after study completion. Many (26/66, 39%) had discrepancies regarding the primary outcome, and nearly two-thirds (42/66, 64%) had discrepancies in secondary outcomes. Discrepancies in study design were less frequent (13/66, 20%). However, large changes in sample size (26/66, 39%) and discrepancies in funding source (28/66, 42%) were frequently observed. Trial registries are important tools for research transparency and identifying and preventing outcome switching and selective outcome reporting bias. Published IPV studies often differ from their records in trial registries. Researchers should pay close attention to the accuracy of trial registry records.

  13. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... trial participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating in clinical trials at the NIH. The NHLBI conducts a large number of ...

  15. Can we screen for pelvic organ prolapse without a physical examination in epidemiologic studies?

    Science.gov (United States)

    Barber, Matthew D; Neubauer, Nikki L; Klein-Olarte, Victoria

    2006-10-01

    Large population-based epidemiologic studies of pelvic organ prolapse are rare. One barrier is the need for physical examination in order to confirm disease status. The objectives of this study were to develop a simple screening question for pelvic organ prolapse (POP) and to evaluate its test characteristics in high and low prevalence populations. Data from 100 women enrolled in the validation study of the Pelvic Floor Distress Inventory (PFDI) were used to identify the question or questions that most accurately identified women with advanced pelvic organ prolapse. After identifying an accurate and reliable screening question from this original group, its test characteristics were evaluated prospectively in 2 additional distinct populations: a group of 120 women presenting to a tertiary care urogynecology clinic (High prior probability of POP) and 448 women presenting to a nurse practitioner for annual gynecologic examination (Low prior probability of POP). Subjects in these 2 groups each completed the screening question and underwent a POPQ examination by a blinded examiner. A single question was identified from the original study population that most accurately and reliably identified those women with POP "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" An affirmative answer to this question was 96% sensitive (95%CI 92-100) and 79% specific (95%CI 77-92) for prolapse beyond the hymen. The 1-week test-retest reliability was good (kappa .84). The prevalence of POP in this group was 29%. No other single question or group of questions had better test characteristics. When prospectively evaluated in the second High probability population (prevalence 39%), similar test characteristics were noted: sensitivity 85% (95%CI 71-93), specificity 86% (95%CI 75-92). However, when evaluated in the Low prior probability group (POP prevalence 3.8%) the specificity improved to 99% (95%CI 98-99), while the sensitivity decreased

  16. Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

    Science.gov (United States)

    Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

    2016-01-28

    Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

  17. Identifying a Computer Forensics Expert: A Study to Measure the Characteristics of Forensic Computer Examiners

    Directory of Open Access Journals (Sweden)

    Gregory H. Carlton

    2010-03-01

    Full Text Available Normal 0 false false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 The usage of digital evidence from electronic devices has been rapidly expanding within litigation, and along with this increased usage, the reliance upon forensic computer examiners to acquire, analyze, and report upon this evidence is also rapidly growing. This growing demand for forensic computer examiners raises questions concerning the selection of individuals qualified to perform this work. While courts have mechanisms for qualifying witnesses that provide testimony based on scientific data, such as digital data, the qualifying criteria covers a wide variety of characteristics including, education, experience, training, professional certifications, or other special skills. In this study, we compare task performance responses from forensic computer examiners with an expert review panel and measure the relationship with the characteristics of the examiners to their quality responses. The results of this analysis provide insight into identifying forensic computer examiners that provide high-quality responses. /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi;}

  18. A STUDY TO ANALYZE VARIOUS FACTORS CONTRIBUTING TO STRESS IN FIRST YEAR MBBS STUDENTS DURING EXAMINATION

    OpenAIRE

    Ganesh, Gajalakshmi; U, Kavitha; B, Anandarajan; M, Chandrasekar

    2012-01-01

    Introduction: Exam stress is a set of responses that includes excessive worry, depression, nervousness and irrelevant thinking to a class of stimuli from an individual’s experience of assessment and outcome. The rationale of this study is to assess the examination related stress among the first year MBBS students by measuring BMI (body mass index) and VAS (Visual  analogue scale) as to determine the factors contributing to exam stress among first year medical students. Methods: The study w...

  19. Exercise, Arterial Crosstalk-Modulation, and Inflammation in an Aging Population: The ExAMIN AGE Study.

    Science.gov (United States)

    Streese, Lukas; Deiseroth, Arne; Schäfer, Juliane; Schmidt-Trucksäss, Arno; Hanssen, Henner

    2018-01-01

    Background: Age is a key determinant for the development of cardiovascular disease and higher age coincides with an increased prevalence of obesity and physical inactivity. The study examines the influence of physical activity on aging processes of physiological systems focusing on the mechanisms of vascular aging. Methods/Design: The study consists of two parts. The cross-sectional approach aims at examining the association of physical fitness and cardiovascular risk with large and small artery function in healthy older active (HOA, n = 40) and sedentary (HOS, n = 40) persons as well as older sedentary individuals with increased cardiovascular risk (OSR, n = 80) aged 50-80 years. In the interventional approach, the OSR group is randomized into a 12-week walking-based high intensity interval training (HIIT) group or a control condition, aiming at examining the effects of HIIT on arterial function in diseased older adults. Active lifestyle is defined as >9 metabolic equivalent of task (MET) per week and sedentary as ≤3 MET/week. Inclusion criteria for OSR are overweight or obesity (body mass index ≥30 kg/m 2 ) plus at least one additional cardiovascular risk factor. The primary outcome is arterial stiffness as determined by aortic pulse wave velocity (PWV). The secondary outcomes are retinal arterial and venous diameters. Further cardiovascular assessments include peripheral PWV, central haemodynamics, retinal endothelial function, carotid intima media thickness, cardiac strain and diastolic function as well as autonomic function and inflammation. Physical fitness is measured by a treadmill-based spiroergometry to determine peak oxygen uptake. Discussion: The aim of the study is to demonstrate the importance of and need for specific physical activity programs for seniors to achieve healthier aging as a long-term goal. Vascular function defines disease- and age-related end organ damage and represents the potential to contain health at older age. This research

  20. Exercise, Arterial Crosstalk-Modulation, and Inflammation in an Aging Population: The ExAMIN AGE Study

    Directory of Open Access Journals (Sweden)

    Lukas Streese

    2018-02-01

    Full Text Available Background: Age is a key determinant for the development of cardiovascular disease and higher age coincides with an increased prevalence of obesity and physical inactivity. The study examines the influence of physical activity on aging processes of physiological systems focusing on the mechanisms of vascular aging.Methods/Design: The study consists of two parts. The cross-sectional approach aims at examining the association of physical fitness and cardiovascular risk with large and small artery function in healthy older active (HOA, n = 40 and sedentary (HOS, n = 40 persons as well as older sedentary individuals with increased cardiovascular risk (OSR, n = 80 aged 50–80 years. In the interventional approach, the OSR group is randomized into a 12-week walking-based high intensity interval training (HIIT group or a control condition, aiming at examining the effects of HIIT on arterial function in diseased older adults. Active lifestyle is defined as >9 metabolic equivalent of task (MET per week and sedentary as ≤3 MET/week. Inclusion criteria for OSR are overweight or obesity (body mass index ≥30 kg/m2 plus at least one additional cardiovascular risk factor. The primary outcome is arterial stiffness as determined by aortic pulse wave velocity (PWV. The secondary outcomes are retinal arterial and venous diameters. Further cardiovascular assessments include peripheral PWV, central haemodynamics, retinal endothelial function, carotid intima media thickness, cardiac strain and diastolic function as well as autonomic function and inflammation. Physical fitness is measured by a treadmill-based spiroergometry to determine peak oxygen uptake.Discussion: The aim of the study is to demonstrate the importance of and need for specific physical activity programs for seniors to achieve healthier aging as a long-term goal. Vascular function defines disease- and age-related end organ damage and represents the potential to contain health at older age. This

  1. Provocative food study (Dreyfuss test): An adjunct to the upper gastrointestinal examination

    International Nuclear Information System (INIS)

    Mueller, P.R.; Hall, D.A.; Wittenberg, J.; Silverman, S.B.; Saini, S.; Cardenosa, G.; Ferrucci, J.T. Jr.

    1988-01-01

    Fifty-two patients with upper gastrointestinal tract symptoms and previously normal barium studies were examined with a provocative food and barium study to assess the functional component of their complaints. Food was given in such nature, quantity, and timing as the clinical history indicated would provoke the exact symptoms or pain that the patient perceived. A position study most often disclosed distension of a previously normal segment of bowel or a hold up of the food in an area of the esophagus or stomach that was associated with recrudescence of the patient's symptoms. Twenty-one of 52 patients (40%) had undergone previous surgery; most often in the esophagus [13 of 52(25%)] or stomach [eight of 52(15%)]. Twelve of 52 patients (23%) had positive studies. Of these, seven (13%) were treated with surgical reconstruction or resection of the abnormal area. The provocative food study, when yielding either positive or negative results, has proved useful

  2. Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies.

    Science.gov (United States)

    Hwang, Thomas J

    2013-01-01

    For biopharmaceutical companies, investments in research and development are risky, and the results from clinical trials are key inflection points in the process. Few studies have explored how and to what extent the public equity market values clinical trial results. Our study dataset matched announcements of clinical trial results for investigational compounds from January 2011 to May 2013 with daily stock market returns of large United States-listed pharmaceutical and biotechnology companies. Event study methodology was used to examine the relationship between clinical research events and changes in stock returns. We identified public announcements for clinical trials of 24 investigational compounds, including 16 (67%) positive and 8 (33%) negative events. The majority of announcements were for Phase 3 clinical trials (N = 13, 54%), and for oncologic (N = 7, 29%) and neurologic (N = 6, 24%) indications. The median cumulative abnormal returns on the day of the announcement were 0.8% (95% confidence interval [CI]: -2.3, 13.4%; P = 0.02) for positive events and -2.0% (95% CI: -9.1, 0.7%; P = 0.04) for negative events, with statistically significant differences from zero. In the day immediately following the announcement, firms with positive events were associated with stock price corrections, with median cumulative abnormal returns falling to 0.4% (95% CI: -3.8, 12.3%; P = 0.33). For firms with negative announcements, the median cumulative abnormal returns were -1.7% (95% CI: -9.5, 1.0%; P = 0.03), and remained significantly negative over the two day event window. The magnitude of abnormal returns did not differ statistically by indication, by trial phase, or between biotechnology and pharmaceutical firms. The release of clinical trial results is an economically significant event and has meaningful effects on market value for large biopharmaceutical companies. Stock return underperformance due to negative events is greater in magnitude and persists longer than

  3. Frequency of discrepancies in retracted clinical trial reports versus unretracted reports: blinded case-control study.

    Science.gov (United States)

    Cole, Graham D; Nowbar, Alexandra N; Mielewczik, Michael; Shun-Shin, Matthew J; Francis, Darrel P

    2015-09-20

    To compare the frequency of discrepancies in retracted reports of clinical trials with those in adjacent unretracted reports in the same journal. Blinded case-control study. Journals in PubMed. 50 manuscripts, classified on PubMed as retracted clinical trials, paired with 50 adjacent unretracted manuscripts from the same journals. Reports were randomly selected from PubMed in December 2012, with no restriction on publication date. Controls were the preceding unretracted clinical trial published in the same journal. All traces of retraction were removed. Three scientists, blinded to the retraction status of individual reports, reviewed all 100 trial reports for discrepancies. Discrepancies were pooled and cross checked before being counted into prespecified categories. Only then was the retraction status unblinded for analysis. Total number of discrepancies (defined as mathematically or logically contradictory statements) in each clinical trial report. Of 479 discrepancies found in the 100 trial reports, 348 were in the 50 retracted reports and 131 in the 50 unretracted reports. On average, individual retracted reports had a greater number of discrepancies than unretracted reports (median 4 (interquartile range 2-8.75) v 0 (0-5); Pretracted than those without a discrepancy (odds ratio 5.7 (95% confidence interval 2.2 to 14.5); Pretracted than unretracted reports: factual discrepancies (P=0.002), arithmetical errors (P=0.01), and missed P values (P=0.02). Results from a retrospective analysis indicated that citations and journal impact factor were unlikely to affect the result. Discrepancies in published trial reports should no longer be assumed to be unimportant. Scientists, blinded to retraction status and with no specialist skill in the field, identify significantly more discrepancies in retracted than unretracted reports of clinical trials. Discrepancies could be an early and accessible signal of unreliability in clinical trial reports. © Cole et al 2015.

  4. Communication about Children's Clinical Trials as Observed and Experienced: Qualitative Study of Parents and Practitioners

    Science.gov (United States)

    Shilling, Valerie; Williamson, Paula R.; Hickey, Helen; Sowden, Emma; Beresford, Michael W.; Smyth, Rosalind L.; Young, Bridget

    2011-01-01

    Background Recruiting children to clinical trials is perceived to be challenging. To identify ways to optimise recruitment and its conduct, we compared how parents and practitioners described their experiences of recruitment to clinical trials. Methods and Findings This qualitative study ran alongside four children's clinical trials in 11 UK research sites. It compared analyses of semi-structured interviews with analyses of audio-recordings of practitioner-family dialogue during trial recruitment discussions. Parents from 59 families were interviewed; 41 had participated in audio-recorded recruitment discussions. 31 practitioners were interviewed. Parents said little in the recruitment discussions contributing a median 16% of the total dialogue and asking a median of one question. Despite this, parents reported a positive experience of the trial approach describing a sense of comfort and safety. Even if they declined or if the discussion took place at a difficult time, parents understood the need to approach them and spoke of the value of research. Some parents viewed participation as an ‘exciting’ opportunity. By contrast, practitioners often worried that approaching families about research burdened families. Some practitioners implied that recruiting to clinical trials was something which they found aversive. Many were also concerned about the amount of information they had to provide and believed this overwhelmed families. Whilst some practitioners thought the trial information leaflets were of little use to families, parents reported that they used and valued the leaflets. However, both parties agreed that the leaflets were too long and wanted them to be more reader-friendly. Conclusions Parents were more positive about being approached to enter their child into a clinical trial than practitioners anticipated. The concerns of some practitioners, that parents would be overburdened, were unfounded. Educating practitioners about how families perceive clinical

  5. HISTOPATHOLOGICAL PROFILE OF LIVER LESIONS IN AUTOPSY EXAMINATION- A HOSPITAL-BASED STUDY

    Directory of Open Access Journals (Sweden)

    Ratan Konjengbam

    2017-06-01

    Full Text Available BACKGROUND Liver is the main site of various primary and secondary diseases including variety of external agents. Most of the chronic liver diseases remained asymptomatic even in the late stage. In apparently healthy persons, many liver lesions are detected incidentally following a postmortem examination. MATERIALS AND METHODS The present study was done for a period of 5 years in a tertiary hospital to evaluate the histopathological profile of liver specimen in autopsy examination. Haematoxylin and Eosin sections of liver specimen were studied. A total of 352 samples were evaluated with male predominates the female sex in the ratio of 5.2:1. RESULTS The most common lesion was fatty liver (19% followed by cirrhosis (11.8%, venous congestion (11.5%, portal triaditis (10.9%, chronic hepatitis (6.2%, granulomatous hepatitis (2.1%, autolysis (16% and others (0.96%. Liver finding was normal in 14% of the cases. CONCLUSION Silent liver diseases are a quite regular finding in autopsy cases and thereby may implicate a common occurrence in general population. Autopsy examination of liver is a must for detection of silent liver diseases like fatty change, cirrhosis and chronic hepatitis.

  6. [A school-level longitudinal study of clinical performance examination scores].

    Science.gov (United States)

    Park, Jang Hee

    2015-06-01

    This school-level longitudinal study examined 7 years of clinical performance data to determine differences (effects) in students and annual changes within a school and between schools; examine how much their predictors (characteristics) influenced the variation in student performance; and calculate estimates of the schools' initial status and growth. A school-level longitudinal model was tested: level 1 (between students), level 2 (annual change within a school), and level 3 (between schools). The study sample comprised students who belonged to the CPX Consortium (n=5,283 for 2005~2008 and n=4,337 for 2009~2011). Despite a difference between evaluation domains, the performance outcomes were related to individual large-effect differences and small-effect school-level differences. Physical examination, clinical courtesy, and patient education were strongly influenced by the school effect, whereas patient-physician interaction was not affected much. Student scores are influenced by the school effect (differences), and the predictors explain the variation in differences, depending on the evaluation domain.

  7. Active Commuting among K-12 Educators: A Study Examining Walking and Biking to Work

    Directory of Open Access Journals (Sweden)

    Melissa Bopp

    2013-01-01

    Full Text Available Background. Walking and biking to work, active commuting (AC is associated with many health benefits, though rates of AC remain low in the US. K-12 educators represent a significant portion of the workforce, and employee health and associated costs may have significant economic impact. Therefore, the purpose of this study was to examine the current rates of AC and factors associated with AC among K-12 educators. Methods. A volunteer sample of K-12 educators ( was recruited to participate in an online survey. Participants responded about AC patterns and social ecological influences on AC (individual, interpersonal, institutional, community, and environmental factors. -tests and ANOVAs examined trends in AC, and Pearson correlations examined the relationship between AC and dependent variables. Multiple regression analysis determined the relative influence of individual, interpersonal, institutional, community, and environmental levels on AC. Results. Participants actively commuted times/week. There were several individual, interpersonal, institutional, community, and environmental factors significantly related to AC. The full model explained 60.8% of the variance in AC behavior. Conclusions. This study provides insight on the factors that determine K-12 educators mode of commute and provide some insight for employee wellness among this population.

  8. Internet-based cognitive behavior therapy for procrastination: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rozental, Alexander; Carlbring, Per

    2013-11-12

    therapist contact. The current study is believed to result in three important findings. First, a CBT intervention is assumed to be beneficial for people suffering from problems caused by procrastination. Second, the degree of therapist contact will have a positive effect on treatment outcome as procrastination can be partially explained as a self-regulatory failure. Third, an Internet based CBT intervention is presumed to be an effective way to administer treatment for procrastination, which is considered highly important, as the availability of adequate care is limited. The current study is therefore believed to render significant knowledge on the treatment of procrastination, as well as providing support for the use of Internet based CBT for difficulties due to delayed tasks and commitments. To our knowledge, the current study is the first clinical trial to examine the effects of CBT for procrastination, and is assumed to render significant knowledge on the treatment of procrastination, as well as investigating whether it can be delivered via the Internet. ClinicalTrials.gov: NCT01842945; http://clinicaltrials.gov/show/NCT01842945 (Archived by WebCite at http://www.webcitation.org/6KSmaXewC).

  9. Electroacupuncture for older adults with mild cognitive impairment: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Leung, Albert Wing Nang; Lam, Linda Chiu Wa; Kwan, Andrew Ka Lun; Tsang, Celia Lai Lin; Zhang, Hong Wei; Guo, Yuan Qi; Xu, Chuan Shan

    2015-05-27

    Mild cognitive impairment is an intermediary state between normal aging and clinical Alzheimer's disease. Early intervention of mild cognitive impairment may be an important strategy in the management of Alzheimer's disease. The proposal aims to evaluate if electroacupuncture would optimize cognitive function in subjects with mild cognitive impairment and understand the role of electroacupuncture in the treatment of Alzheimer's disease. A randomised patient- and assessor-blind sham-controlled trial is designed to assess whether electroacupuncture intervention decreases the rate of cognitive decline amongst older adults with mild cognitive impairment. One hundred and fifty subjects aged 65 years of age or over with a diagnosis of mild cognitive impairment are recruited from the community and elderly centre in Hong Kong. All subjects are randomly allocated into two groups (75 subjects each group): the electroacupuncture group and sham control. Participants in the electroacupuncture group receive electroacupuncture stimulation by sterile, disposable acupuncture needles inserted to the acupoints with a depth of 1 to 3 cm. The acupuncture needles are subjected to 2 Hz electroacupuncture with an intensity of 5 to 10 mA. Each participant receives electroacupuncture for 8 weeks (once a day, 3 days a week) and the treatment lasts for 30 minutes each time. For sham electroacupuncture, needles are inserted to a depth of 1 to 2 mm, and connected to the electroacupuncture device without any current passing through. Outcome measures (including primary and secondary outcome measures) are collected at baseline, at the end day of intervention, and months 4 and 6 after intervention. The primary outcome is measured by the Alzheimer Disease Assessment Scale-Cognitive subscale. Secondary outcomes are measured by the mini-mental state examination, category fluency text and the Short Form 12. The study will provide evidence for evaluating and understanding the role of electroacupuncture

  10. Study design of ASPirin in Reducing Events in the Elderly (ASPREE): a randomized, controlled trial.

    Science.gov (United States)

    2013-11-01

    Cost-effective strategies to maintain healthy active lifestyle in aging populations are required to address the global burden of age-related diseases. ASPREE will examine whether the potential primary prevention benefits of low dose aspirin outweigh the risks in older healthy individuals. Our primary hypothesis is that daily oral 100 mg enteric-coated aspirin will extend a composite primary endpoint termed 'disability-free life' including onset of dementia, total mortality, or persistent disability in at least one of the Katz Activities of Daily Living in 19,000 healthy participants aged 65 years and above ('US minorities') and 70 years and above (non-'US minorities'). ASPREE is a double-blind, randomized, placebo-controlled trial of oral 100mg enteric-coated acetyl salicylic acid (ASA) or matching placebo being conducted in Australian and US community settings on individuals free of dementia, disability and cardiovascular disease (CVD) events. Secondary endpoints are all-cause and cause specific mortality, fatal and non-fatal cardiovascular events, fatal and non-fatal cancer (excluding non-melanoma skin cancer), dementia, mild cognitive impairment, depression, physical disability, and clinically significant bleeding. To 20 September 2013 14,383 participants have been recruited. Recruitment and study completion are anticipated in July 2014 and December 2018 respectively. In contrast to other aspirin trials that have largely focused on cardiovascular endpoints, ASPREE has a unique composite primary endpoint to better capture the overall risk and benefit of aspirin to extend healthy independent lifespan in older adults in the US and Australia. © 2013. Published by Elsevier Inc. All rights reserved.

  11. A preliminary study of empathy, emotional intelligence and examination performance in MBChB students.

    Science.gov (United States)

    Austin, Elizabeth J; Evans, Phillip; Magnus, Belinda; O'Hanlon, Katie

    2007-07-01

    There is considerable interest in the attributes other than cognitive ability that medical students need in order to be professionally successful, with a particular focus on empathy and emotional intelligence (EI). Selection considerations have also motivated interest in such attributes as predictors of academic success. There are reports of declines in empathy in US medical students, but no comparative information is available for UK students. This study aimed to compare empathy levels in medical students in Years 2, 3 (pre-clinical) and 5 (clinical), to examine gender differences in empathy and EI, and to investigate whether EI and empathy are related to academic success. Questionnaires assessing EI and empathy were completed by students. Previous empathy scores for the Year 2 cohort were also available. Empathy trends were examined using anova; trends for the Year 2 group for whom Year 1 scores were available were examined using repeated-measures anova. Associations of EI and empathy with academic success were examined using Pearson correlation. A significant gender x cohort effect was found, with male empathy scores increasing between Years 1 and 2, whilst female scores declined. Peer ratings in Year 2 problem-based learning (PBL) groups were positively correlated with EI. Trends in levels of empathy differed by gender. The reasons for this require further investigation, particularly in relation to course content. Associations between academic performance and EI were sparse, and there were none between academic performance and empathy, but the effects of EI (and other characteristics) on PBL group functioning represent a promising area for future study.

  12. Examining the Efficacy of Adjunctive Aripiprazole in Major Depressive Disorder: A Pooled Analysis of 2 Studies

    Science.gov (United States)

    Thase, Michael E.; Trivedi, Madhukar H.; Nelson, J. Craig; Fava, Maurizio; Swanink, Rene; Tran, Quynh-Van; Pikalov, Andrei; Yang, Huyuan; Carlson, Berit X.; Marcus, Ronald N.; Berman, Robert M.

    2008-01-01

    Background: Patients with major depressive disorder (MDD) who fail to achieve complete remission with antidepressant therapy may benefit from augmentation therapy with an atypical antipsychotic. Method: A pooled analysis was performed on 2 identical 14-week studies (8-week prospective antidepressant therapy treatment phase followed by 6-week randomized double-blind phase) evaluating the efficacy of adjunctive aripiprazole (2–20 mg/day) in DSM-IV-TR–defined MDD patients with an inadequate response to antidepressant therapy. Primary efficacy endpoint was the mean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from end of the prospective phase (week 8) to end of randomized phase (week 14, last observation carried forward). Subgroup analyses were performed. The key secondary endpoint was mean change in Sheehan Disability Scale (SDS) mean score. Results: At endpoint, mean change in MADRS total score was significantly greater with adjunctive aripiprazole (–8.7) than with adjunctive placebo (–5.7; p < .001). Except for a differential treatment-by-sex interaction, change in MADRS total scores were consistently greater with adjunctive aripiprazole than with adjunctive placebo, regardless of race, age, episode duration, prior antidepressant therapy response, number of historical treatment failures, severity of depressive symptoms, and antidepressant. At endpoint, MADRS remission rates were significantly greater with adjunctive aripiprazole than with placebo (25.7% vs. 15.4%; p < .001). Adjunctive aripiprazole also demonstrated significantly greater improvements in mean change from baseline in SDS total score than adjunctive placebo (–1.2 vs. –0.6; p = .001). Conclusion: Augmentation of antidepressant therapy with the atypical antipsychotic aripiprazole resulted in significant efficacy benefits across a range of subgroups of patients with MDD. Further study of a treatment-by-sex interaction is needed. Trial Registration: www

  13. Using new technologies to promote weight management: a randomised controlled trial study protocol.

    Science.gov (United States)

    Jane, Monica; Foster, Jonathan; Hagger, Martin; Pal, Sebely

    2015-05-27

    Over the last three decades, overweight and obesity and the associated health consequences have become global public health priorities. Methods that have been tried to address this problem have not had the desired impact, suggesting that other approaches need to be considered. One of the lessons learned throughout these attempts is that permanent weight loss requires sustained dietary and lifestyle changes, yet adherence to weight management programs has often been noted as one of the biggest challenges. This trial aims to address this issue by examining whether social media, as a potential health promotion tool, will improve adherence to a weight management program. To test the effectiveness of this measure, the designated program will be delivered via the popular social networking site Facebook, and compared to a standard delivery method that provides exactly the same content but which is communicated through a pamphlet. The trial will be conducted over a period of twelve weeks, with a twelve week follow-up. Although weight loss is expected, this study will specifically investigate the effectiveness of social media as a program delivery method. The program utilised will be one that has already been proven to achieve weight loss, namely The CSIRO Total Wellbeing Diet. This project will be conducted as a 3-arm randomised controlled trial. One hundred and twenty participants will be recruited from the Perth community, and will be randomly assigned to one of the following three groups: the Facebook group, the pamphlet group, or a control group. The Facebook Group will receive the weight management program delivered via a closed group in Facebook, the Pamphlet Group will be given the same weight management program presented in a booklet, and the Control Group will follow the Australian Dietary Guidelines and the National Physical Activity Guidelines for Adults as usual care. Change in weight, body composition and waist circumference will be initial indicators of

  14. Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial.

    Science.gov (United States)

    Weiss, David M; Casten, Robin J; Leiby, Benjamin E; Hark, Lisa A; Murchison, Ann P; Johnson, Deiana; Stratford, Shayla; Henderer, Jeffrey; Rovner, Barry W; Haller, Julia A

    2015-09-01

    African American individuals are at high risk of diabetes mellitus and diabetic retinopathy but have suboptimal rates of dilated fundus examinations (DFEs). Early intervention is crucial for the prevention of diabetic retinopathy in this high-risk population. To test the efficacy of behavioral activation for diabetic retinopathy prevention on rates of DFEs in older African American individuals with diabetes mellitus. Masked randomized clinical trial at 2 urban medical centers from October 1, 2010, to May 31, 2014. Participants included 206 African American individuals 65 years and older with diabetes mellitus who had not obtained a DFE in the preceding 12 months. Participants were randomized to either behavioral activation for diabetic retinopathy prevention, a behavioral intervention designed to provide education, facilitate identifying and addressing health care barriers, and promote goal setting to improve rates of DFEs, or supportive therapy, a control condition. The primary outcome was medical documentation of a DFE at 6 months' follow-up. Secondary outcomes included the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus, Diabetes Self-Care Inventory, Patient Health Questionnaire 9, and National Eye Institute Vision Function Questionnaire 25 scores and hemoglobin A1c levels. More participants in the behavioral activation for diabetic retinopathy prevention group (87.9%) obtained a DFE compared with those in the supportive therapy group (34.1%) by the 6-month follow-up assessment (P < .001). Overall, participants in the behavioral activation for diabetic retinopathy prevention group were 2.5 times more likely to obtain a DFE compared with those in the supportive therapy group (risk ratio = 2.58; 95% CI, 1.91-3.48; P < .001). The intervention had no short-term effect on secondary outcomes of hemoglobin A1c levels, depression, or the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus or National Eye Institute Vision Function

  15. Feasibility Study for Electronic Fitness for Duty Medical Examination Reporting and Oversight.

    Science.gov (United States)

    2016-11-01

    This report examines the institutional and high-level technology aspects associated with potential mandated : electronic reporting of every commercial driver license (CDL) driver fitness-for-duty medical examination : performed by a medical examiner ...

  16. Examining the Use of a Visual Analytics System for Sensemaking Tasks: Case Studies with Domain Experts.

    Science.gov (United States)

    Kang, Youn-Ah; Stasko, J

    2012-12-01

    While the formal evaluation of systems in visual analytics is still relatively uncommon, particularly rare are case studies of prolonged system use by domain analysts working with their own data. Conducting case studies can be challenging, but it can be a particularly effective way to examine whether visual analytics systems are truly helping expert users to accomplish their goals. We studied the use of a visual analytics system for sensemaking tasks on documents by six analysts from a variety of domains. We describe their application of the system along with the benefits, issues, and problems that we uncovered. Findings from the studies identify features that visual analytics systems should emphasize as well as missing capabilities that should be addressed. These findings inform design implications for future systems.

  17. Components of a successful intervention for monthly skin self-examination for early detection of melanoma: the "Check It Out" trial.

    Science.gov (United States)

    Lee, Katherine B; Weinstock, Martin A; Risica, Patricia M

    2008-06-01

    Multicomponent Check-It-Out project interventions were found to be effective at increasing thorough skin self-examinations (TSSE). Application of this research will benefit from determining the most important interventions for promoting TSSE. Identification of the most important Check-It-Out intervention components for promoting TSSE. This study analyzed the responses of the 567 participants who were randomized into the skin examination intervention group and who did not report performing TSSE at their baseline interview. Watching the video, using the hand mirror, shower card, American Cancer Society brochure, sample photographs, and finding the health educator helpful were associated with performing TSSE at 2 months, 12 months, or both. Use of the materials within the skin group was not randomly assigned. All data were based on participant self-report. As future interventions to increase TSSE are developed, the identified useful components will be important to include.

  18. A Nutrition Education Intervention Trial for Adolescent Girls in Isfahan: Study Design and Protocol

    Directory of Open Access Journals (Sweden)

    Morvarid Ghasab Shirazi

    2016-11-01

    Full Text Available BackgroundNutrition behaviors of adolescent girls is of serious health concerns. Although nutrition education interventions in Iran have met with some success, most of them could not promote nutrition behavioral changes. The aim of our study is to determine a school-based nutrition education intervention to improve adolescents’ nutrition behaviors and behavioral mediators based on the social cognitive theory (SCT.Materials and MethodsThis study is a single-blind randomized controlled trial. Eligible participants will be all student girls in grade 6 and 7, their parents and teachers in Isfahan governmental schools. This multi com­ponent school-based intervention include adolescents’ nutrition education package, parents’ nutrition massages, participatory homework, parents and teachers nutrition education package, supportive group, and collaboration with decision makers. Changing in nutrition behaviors including breakfast, fruit and vegetable, snack and fast food consumption will be examined, as primary outcome. Secondary outcome will be behavioral mediators such as knowledge, self-efficacy, intention, situation, self-regulation, social support, outcome expectations and expectancies, in adolescent girls. The outcomes will be assessed at baseline, and after 3 and 6-month follow-up.DiscussionThis study evaluates a school-based, guided SCT intervention, designed to improve healthy dietary behaviors, nutrition knowledge of adolescent girls. Few behavioral interventions have targeted this high-risk population in Iran. The intervention seems to be promising and has the potential to bridge the gap of the limited program outcomes of nutrition education in Iranian adolescents.

  19. Cheating in Examinations: A Study of Academic Dishonesty in a Malaysian College

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    Sara Asmawati Shariffuddin

    2009-12-01

    Full Text Available Recent empirical studies indicate that cheating by post-secondary students is prevalent in many countries. This study attempts to explore academic dishonesty among students at Terengganu Advanced Technical Institute University College (TATiUC in Malaysia. Cheating techniques, preventive measures and the support required by lecturers to handle cheating incidents were examined. Six former students who were confirmed cheaters and two lecturers and administrators at TATiUC participated in the study. Data were collected by using narrative responses and interviews. The results showed that creative and innovative techniques were used to cheat successfully. It was also found that participants believed that even if preventive measures were taken, it was not possible to stop academic cheating entirely although it could be deterred to a certain extent. Furthermore, it was discovered that there were variations in the implementation of examination rules and regulations by lecturers. Finally, the study revealed that support in terms of training and courses was needed to deal with academic dishonesty.

  20. The fate of prospective spine studies registered on www.ClinicalTrials.gov.

    Science.gov (United States)

    Ohnmeiss, Donna D

    2015-03-01

    There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the treatment of their particular condition. The internationally available site offers general information about the study, sponsor name, principal investigator, patient selection criteria, enrollment goal, study design, outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent data. The site can be used to identify studies conducted for a particular condition or intervention. The purpose of this study was to investigate the fate of spine-related studies registered on www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials. Analysis and classification of clinical studies posted on an international research registry Web page and literature search for related publications. Not applicable. The primary outcome measure was publication of the study registered on ClinicalTrials.gov. Multiple searches were conducted on ClinicalTrials.gov Web site to identify studies related to commonly treated spinal conditions, including herniated disc, degenerative disc disease, stenosis, and spondylolisthesis. Studies related to tumors, fractures, or that included nonspine conditions were not included. For studies classified as completed more than 18 months before this review, literature searches were conducted to determine if the results of the study had been published and factors related to publication. The author has no financial conflict related to this work. There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site. Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally indicates collecting follow-up data), 74 recruiting, 11 recruiting by

  1. Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study.

    Science.gov (United States)

    Hurley, Caroline; Sinnott, Carol; Clarke, Mike; Kearney, Patricia; Racine, Emmy; Eustace, Joseph; Shiely, Frances

    2017-09-11

    In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a 'gold standard', validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists' readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland. This is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues. Survey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants' legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials. The results of this study demonstrate a need for training and regulatory-endorsed guidelines to

  2. Cooperative Group Performance in Graduate Research Methodology Courses: The Role of Study Coping and Examination-Taking Coping Strategies

    Science.gov (United States)

    Jiao, Qun G.; Collins, Kathleen M. T.; Onwuegbuzie, Anthony J.

    2013-01-01

    This study seeks to examine the extent to which cooperative group members' levels of coping strategies (study and examination-taking coping strategies) and the degree that heterogeneity (variability of study coping strategies and examination-taking coping strategies) predict cooperative groups' levels of achievement in research methodology…

  3. Comparative effectiveness of initial antiretroviral therapy regimens: ACTG 5095 and 5142 clinical trials relative to ART-CC cohort study

    NARCIS (Netherlands)

    Mugavero, Michael J.; May, Margaret; Ribaudo, Heather J.; Gulick, Roy M.; Riddler, Sharon A.; Haubrich, Richard; Napravnik, Sonia; Abgrall, Sophie; Phillips, Andrew; Harris, Ross; Gill, M. John; de Wolf, Frank; Hogg, Robert; Günthard, Huldrych F.; Chêne, Geneviève; D'Arminio Monforte, Antonella; Guest, Jodie L.; Smith, Colette; Murillas, Javier; Berenguer, Juan; Wyen, Christoph; Domingo, Pere; Kitahata, Mari M.; Sterne, Jonathan A. C.; Saag, Michael S.; Shikuma, Cecilia M.; Ribaudo, Heather; Lalama, Christina; Klingman, Karin K.; Bastow, Barbara; Kmack, Anne; Meyer, William A.; Kutitzkes, Daniel R.; Acosta, Edward P.; Hughes, Valery; Squires, Kathleen E.; Shackman, Bruce R.; Schouten, Jeffrey T.; Parrillo, Vincent; Martinez, Ana I.; Fallis, Richard; Storfer, Stephen P.; Giordano, Michael; McDonough, Marita; Rooney, James; Rugh, Lynn; Ryan, Kirk; Tolson, Jerry; van Kempen, Amy S.; Schnizlein Bick, Carol; Webb, Nancy; DiRienzo, A. Gregory; Peeples, Lynne; Powderly, William G.; Klingman, Karin L.; Garren, Kevin W.; George, Tania; Rooney, James F.; Brizz, Barbara; Lalloo, Umesh G.; Murphy, Robert L.; Swindells, Susan; Havlir, Diane; Mellors, John W.

    2011-01-01

    The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients

  4. Mexican-American perspectives on participation in clinical trials: A qualitative study

    Directory of Open Access Journals (Sweden)

    Mariana Arevalo

    2016-12-01

    Full Text Available Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; however, ethnic and racial minorities remain under-represented in those studies. We explored knowledge and perceptions of clinical trials among Mexican-Americans in Texas. We conducted focus groups (N = 128 stratified by gender, language preference, and geographical location. This paper presents four emergent, primary themes: 1 knowledge and understanding of clinical trials, 2 fears and concerns about participating, 3 perceived benefits of participating, and 4 incentives to participate. Results suggest that lack of knowledge and understanding of clinical trials leads to misunderstanding about research, including fears and lack of trust. Participants indicated that fears related to perceived experimentation, harm, immigration status, and lack of clinical trial opportunities within their communities were barriers to participation. On the other hand, free healthcare access, helping family members in the future, and monetary incentives could facilitate participation. We also found differences across themes by language, gender, and place of residence. Findings from our study could inform the development of interventions to enhance recruitment of Mexican-American participants into clinical trials.

  5. Ultrastructural and histological findings on examination of skin in osteogenesis imperfecta: a novel study.

    Science.gov (United States)

    Balasubramanian, Meena; Wagner, Bart E; Peres, Luiz C; Sobey, Glenda J; Parker, Michael J; Dalton, Ann; Arundel, Paul; Bishop, Nicholas J

    2015-04-01

    Osteogenesis imperfecta (OI) is a heterogeneous group of inherited disorders of bone formation, resulting in low bone mass and an increased propensity for fractures. It is a variable condition with a range of clinical severities. The histological and ultrastructural findings in the skin of patients with OI have not been described in detail in the previously published literature. Although protein analysis of cultured fibroblasts has historically been used in the diagnostic work-up of OI patients, other aspects of skin examination are not routinely performed as part of the diagnostic pathway in patients with OI. The aims of this study were to perform histological and ultrastructural examination of skin biopsies in patients with OI. This was to identify common and distinguishing features in the numerous genetically distinct subtypes of OI and compare the findings with those in patients who did not present with fractures, and to enable the use of the results thus obtained to aid in the diagnostic work-up of patients with OI. As part of a larger research study set-up to identify clinical features and natural history in patients with atypical features of OI, skin biopsy and examination (histology and electron microscopy) were undertaken. Genetic analysis and ancillary investigations were also performed to identify similarities within this group and to differentiate this group from the 'normal' population. At the end of this study, we were able to demonstrate that the histological and electron microscopic findings on a skin biopsy may be an indicator of the likelihood of identifying a pathogenic mutation in type 1 collagen genes. This is because patients with specific findings on examination, such as elastic fibre area fraction (on histological analysis), collagen fibril diameter variability, deviation from the expected mean and collagen flowers (on electron microscopy), are more likely to be positive on genetic analyses. This has, in turn, provided more insight into the

  6. Epidemiological Interpretation of Studies Examining the Effect of Antibiotic Usage on Resistance

    Science.gov (United States)

    Schechner, Vered; Temkin, Elizabeth; Harbarth, Stephan; Carmeli, Yehuda

    2013-01-01

    SUMMARY Bacterial resistance to antibiotics is a growing clinical problem and public health threat. Antibiotic use is a known risk factor for the emergence of antibiotic resistance, but demonstrating the causal link between antibiotic use and resistance is challenging. This review describes different study designs for assessing the association between antibiotic use and resistance and discusses strengths and limitations of each. Approaches to measuring antibiotic use and antibiotic resistance are presented. Important methodological issues such as confounding, establishing temporality, and control group selection are examined. PMID:23554418

  7. Screening of the pelvic organ prolapse without a physical examination; (a community based study

    Directory of Open Access Journals (Sweden)

    Tehrani Fahimeh

    2011-11-01

    Full Text Available Abstract Background Pelvic organ prolapse (POP is a silent disorder with a huge impact on women's quality of life. There is limited data from community-based studies conducted to determine the prevalence of POP as its assessment needs a pelvic examination. We aimed to develop a simple screening inventory for identification of pelvic organ prolapse and then evaluate its sensitivity and specificity. Methods This study had two phases. In the first phase in order to develop a simple inventory for assessment of POP, the Pelvic Floor Disorder Inventory (PFDI was completed for a convenience sample of 200 women, aged 18-45 years, referred for annual gynecologic examination, and their pelvic organ prolapse was assessed using the standard protocol. The most sensitive and specific questions were selected as pelvic organ prolapse simple screening inventory (POPSSI. In the second phase, using a stratified multistage probability cluster sampling method, the sensitivity and specificity of the POPSSI was investigated in a non selected sample of 954 women recruited from among reproductive aged women living in four randomly selected provinces of Iran. Results The sensitivity and specificity of POPSSI for identification of pelvic organ prolapse in the general population were 45.5 and 87.4% respectively; these values were 96.7 and 20% among those women who were aware of their pelvic dysfunction. Conclusion Community based screening studies on pelvic organ prolapse could be facilitated by using the POPSSI, the sensitivity of which would be enhanced through conducting of public awareness programs.

  8. Screening of the pelvic organ prolapse without a physical examination; (a community based study).

    Science.gov (United States)

    Tehrani, Fahimeh Ramezani; Hashemi, Somayeh; Simbar, Masoumeh; Shiva, Niloofar

    2011-11-15

    Pelvic organ prolapse (POP) is a silent disorder with a huge impact on women's quality of life. There is limited data from community-based studies conducted to determine the prevalence of POP as its assessment needs a pelvic examination. We aimed to develop a simple screening inventory for identification of pelvic organ prolapse and then evaluate its sensitivity and specificity. This study had two phases. In the first phase in order to develop a simple inventory for assessment of POP, the Pelvic Floor Disorder Inventory (PFDI) was completed for a convenience sample of 200 women, aged 18-45 years, referred for annual gynecologic examination, and their pelvic organ prolapse was assessed using the standard protocol. The most sensitive and specific questions were selected as pelvic organ prolapse simple screening inventory (POPSSI). In the second phase, using a stratified multistage probability cluster sampling method, the sensitivity and specificity of the POPSSI was investigated in a non selected sample of 954 women recruited from among reproductive aged women living in four randomly selected provinces of Iran. The sensitivity and specificity of POPSSI for identification of pelvic organ prolapse in the general population were 45.5 and 87.4% respectively; these values were 96.7 and 20% among those women who were aware of their pelvic dysfunction. Community based screening studies on pelvic organ prolapse could be facilitated by using the POPSSI, the sensitivity of which would be enhanced through conducting of public awareness programs.

  9. Effects of Normobaric Hyperoxia in Severe Acute Stroke: a Randomized Controlled Clinical Trial Study.

    Science.gov (United States)

    Mazdeh, Mehrdokht; Taher, Abbas; Torabian, Saadat; Seifirad, Soroush

    2015-11-01

    Oxygen therapy might increase damaged tissue oxygenation, turn on the aerobic pathway, and save neurons from death and could improve clinical outcome of the patients with stroke and head trauma. Hyperbaric oxygen therapy is accompanied by some unfavorable effects. Results of normobaric oxygen therapy on clinical outcomes of patients with stroke were controversial up till now.  This study was therefore designed to evaluate effects of normobaric hyperoxia on clinical outcomes of patients with severe acute stroke. A total of 52 consecutive patients with stroke who meet the inclusion criteria of the study were entered into this randomized controlled clinical trial. The patients in the case group underwent oxygen therapy with Venturi mask for first 12 hours of admission. The patients were examined for neurologic defects at the time of discharge and after six months using both Barthel and modified Rankin Scale (mRS) neurologic disability scoring systems. There was no significant sex difference between the two groups (P=0.5). There was no statistically significant difference between ischemic-hemorrhagic stroke constitutions of two groups (P=0.2). There were no significant difference in Barthel index scores of both groups at the time of discharge as well as the follow-up examination (P=0.7) According to the mRS scoring system, there was no difference between the patients of both groups at the time of admission (P= 0.8), however after treatment there was a significant difference between mRS scores of the treated group compared to the controls (P=0.04). According to the results of this study, normobaric oxygen therapy in the first 12 hours of accident could improve long time outcome of the patients with either ischemic or hemorrhagic stroke.

  10. Clinical Trials

    Medline Plus

    Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

  11. Basic heart examination: feasibility study of first-trimester systematic simplified fetal echocardiography.

    Science.gov (United States)

    Quarello, E; Lafouge, A; Fries, N; Salomon, L J

    2017-02-01

    First-trimester fetal cardiac screening examinations in low-risk populations should not have to meet the specifications required for high-risk populations. Our aim was to evaluate a simplified fetal echocardiographic ('basic heart') examination for early detection of severe congenital heart defects in a low-risk population. This was a first-trimester national 'flash study', performed over a 2-week period. Each observer was requested to perform simplified echocardiography without modifying the time and methods deemed necessary for the routine first-trimester ultrasound examination, in fetuses with crown-rump length between 45 and 84 mm. This basic heart assessment used targeted cross-sections of the four-chamber view (4CV) and of the three vessels and trachea (3VT) view, using color and/or directional power Doppler. All examinations were then reviewed offline and scored for quality by a qualified expert. Sixty observers performed a total of 597 first-trimester ultrasound examinations, each performing an average of 10 (range, 1-26) procedures. Examinations were conducted transabdominally (79%; 472/597), transvaginally (3%; 17/597) or both (18%; 108/597). In 8% (45/597) of cases, the fetal back was anterior, in 18% (108/597) it was on the left side, in 63% (377/597) it was posterior and in 11% (67/597) it was on the right side. It became clear during scoring by the expert that, unlike the Herman quality score for nuchal translucency measurement, it was difficult to assess the quality of these images without taking into account normality of the heart itself. Analysis of scores showed that the 4CV was obtained successfully and was deemed normal in 86% (512/597) of the patients, in 7% (41/597) it was deemed technically infeasible and in 7% (44/597) it was deemed feasible but atypical, which may have been due to the presence of an abnormality or to poor quality of the image. The 3VT view was obtained successfully and was normal in 79% (472/597) of the patients, in 13

  12. Alzheimer's disease - input of vitamin D with mEmantine assay (AD-IDEA trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gautier Jennifer

    2011-10-01

    Full Text Available Abstract Background Current treatments for Alzheimer's disease and related disorders (ADRD are symptomatic and can only temporarily slow down ADRD. Future possibilities of care rely on multi-target drugs therapies that address simultaneously several pathophysiological processes leading to neurodegeneration. We hypothesized that the combination of memantine with vitamin D could be neuroprotective in ADRD, thereby limiting neuronal loss and cognitive decline. The aim of this trial is to compare the effect after 24 weeks of the oral intake of vitamin D3 (cholecalciferol with the effect of a placebo on the change of cognitive performance in patients suffering from moderate ADRD and receiving memantine. Methods The AD-IDEA Trial is a unicentre, double-blind, randomized, placebo-controlled, intent-to-treat, superiority trial. Patients aged 60 years and older presenting with moderate ADRD (i.e., Mini-Mental State Examination [MMSE] score between 10-20, hypovitaminosis D (i.e., serum 25-hydroxyvitamin D [25OHD] Discussion The combination of memantine plus vitamin D may represent a new multi-target therapeutic class for the treatment of ADRD. The AD-IDEA Trial seeks to provide evidence on its efficacy in limiting cognitive and functional declines in ADRD. Trial Registration ClinicalTrials.gov number, NCT01409694

  13. Prophylactic effect of low dose vitamin D in osteopenia of prematurity: a clinical trial study.

    Directory of Open Access Journals (Sweden)

    Paymaneh Alizadeh Taheri

    2014-09-01

    Full Text Available Osteopenia of prematurity (OOP is a preventable disease. Improved survival of premature newborns is associated with an increased incidence of OOP. The purpose of this study was to compare the prophylactic effects of two low doses of vitamin D (200 and 400 IU/Day on the clinical, biochemical and radiological indices of the rickets of prematurity. In a randomized clinical trial, 60 preterm newborns with birth weight < 2000 g & gestational age < 37 weeks were randomly divided in two groups. Thirty newborns received 200 IU/d of vitamin D in group one and 30 ones received 400 IU/day of vitamin D in group two. On the 6th to 8th weeks of life, serum calcium, phosphate, alkaline phosphates, and 25-hydroxy vitamin D concentrations were measured and x- ray of left wrist and physical examination were performed. Both groups had no difference in biochemical, radiological or clinical presentation of rickets. Current study indicated that low dose vitamin D (200 IU/Day is enough for prevention of OOP.

  14. Evaluation of a Topical Anti-inflammatory/Antifungal Combination Cream in Mild-to-moderate Facial Seborrheic Dermatitis: An Intra-subject Controlled Trial Examining Treated vs. Untreated Skin Utilizing Clinical Features and Erythema-directed Digital Photography.

    Science.gov (United States)

    Dall'Oglio, Federica; Tedeschi, Aurora; Guardabasso, Vincenzo; Micali, Giuseppe

    2015-09-01

    To evaluate if nonprescription topical agents may provide positive outcomes in the management of mild-to-moderate facial seborrheic dermatitis by reducing inflammation and scale production through clinical evaluation and erythema-directed digital photography. Open-label, prospective, not-blinded, intra-patient, controlled, clinical trial (target area). Twenty adult subjects affected by mild-to-moderate facial seborrheic dermatitis were enrolled and instructed to apply the study cream two times daily, initially on a selected target area only for seven days. If the subject developed visible improvement, it was advised to extend the application to all facial affected area for 21 additional days. Efficacy was evaluated by measuring the grade of erythema (by clinical examination and by erythema-directed digital photography), desquamation (by clinical examination), and pruritus (by subject-completed visual analog scale). Additionally, at the end of the protocol, a Physician Global Assessment was carried out. Eighteen subjects completed the study, whereas two subjects were lost to follow-up for nonadherence and personal reasons, respectively. Day 7 data from target areas showed a significant reduction in erythema. At the end of study, a significant improvement was recorded for erythema, desquamation, and pruritus compared to baseline. Physician Global Assessment showed improvement in 89 percent of patients, with a complete response in 56 percent of cases. These preliminary results indicate that the study cream may be a viable nonprescription therapeutic option for patients affected by facial seborrheic dermatitis able to determine early and significant improvement. This study also emphasizes the advantages of using an erythema-directed digital photography system for assisting in a simple, more accurate erythema severity grading and therapeutic monitoring in patients affected by seborrheic dermatitis.

  15. What Value Can Qualitative Research Add to Quantitative Research Design? An Example From an Adolescent Idiopathic Scoliosis Trial Feasibility Study.

    Science.gov (United States)

    Toye, Francine; Williamson, Esther; Williams, Mark A; Fairbank, Jeremy; Lamb, Sarah E

    2016-08-09

    Using an example of qualitative research embedded in a non-surgical feasibility trial, we explore the benefits of including qualitative research in trial design and reflect on epistemological challenges. We interviewed 18 trial participants and used methods of Interpretive Phenomenological Analysis. Our findings demonstrate that qualitative research can make a valuable contribution by allowing trial stakeholders to see things from alternative perspectives. Specifically, it can help to make specific recommendations for improved trial design, generate questions which contextualize findings, and also explore disease experience beyond the trial. To make the most out of qualitative research embedded in quantitative design it would be useful to (a) agree specific qualitative study aims that underpin research design, (b) understand the impact of differences in epistemological truth claims, (c) provide clear thematic interpretations for trial researchers to utilize, and (d) include qualitative findings that explore experience beyond the trial setting within the impact plan. © The Author(s) 2016.

  16. Correlative Studies in Clinical Trials: A Position Statement From the International Thyroid Oncology Group.

    Science.gov (United States)

    Bible, Keith C; Cote, Gilbert J; Demeure, Michael J; Elisei, Rossella; Jhiang, Sissy; Ringel, Matthew D

    2015-12-01

    Patients with progressive thyroid cancer in distant metastatic sites represent a population with a need for new therapeutic options. Aspiring to improve the treatment of such patients, the objective of this position statement from the International Thyroid Oncology Group (ITOG) is to clarify the importance of incorporating high-quality correlative studies into clinical trials. ITOG was formed to develop and support high-quality multicenter and multidisciplinary clinical trials for patients with aggressive forms of thyroid cancer. The Correlative Sciences Committee of the ITOG focuses on the quality and types of correlative studies included in ITOG-associated clinical trials. This document represents expert consensus from ITOG regarding this issue based on extensive collective experience in clinical and translational trials informed by basic science. The Correlative Studies Committee identified an international writing group representative of diverse specialties, including basic sciences. Drafts were reviewed by all members of the writing group, the larger committee, and the ITOG board. After consideration of all comments by the writing group and modification of the document, the final document was then approved by the authors and the ITOG board. High-quality correlative studies, which include variety in the types of correlates, should be intrinsic to the design of thyroid cancer clinical trials to offer the best opportunity for each study to advance treatment for patients with advanced and progressive thyroid cancer.

  17. FORMAL ORAL INDONESIAN REGISTER USED IN OPEN EXAMINATION A SYNTHATICAL-PRAGMATIC STUDY

    Directory of Open Access Journals (Sweden)

    Ni Wayan Sartini

    2013-02-01

    Full Text Available This study explored the formal oral Indonesian register ‘Bahasa Indonesia ragam lisan formal’ (hereinafter referred to as BIRLF used in open examinations from syntactical-pragmatic perspective. In general, this study aims at analyzing the grammatical-pragmatic elements of the formal oral register used in open examinations; in particular, it aims at analyzing the forms of speech acts and the forms of politeness used in the open examinations held at the University of Airlangga ‘Universitas Airlangga’ (Unair and the State University of Surabaya ‘Universitas Negeri Surabaya’ (Unesa. The theories used were the structural theory and the theory of pragmatics. The structural theory was used to analyze the grammatical structures of the sentences used in the dialogues taking place in the open examinations. The theory of pragmatics used in this study refers to the theory of politeness proposed by Lakoff (1972, Leech (1983, Brown and Levinson (1987, and the theory of speech act developed by Austin (1962 and Searle (1975. The data analysis showed that, based on the direction of extension in which the verb was the center, and the extending components, eleven types of imperative sentences were found. The extension took place to the left, to the right and to the left and to the right from the verb simultaneously. The extending components included words, phrases, clauses and combinations of phrases and clauses. The interrogative sentences used were both the close interrogative sentences and the open interrogative ones. The declarative sentences used were the complex coordinative and subordinative ones. Deletion, pronominalization,, and repetition characterized the two types of sentences. To identify politeness, the layers of the components constructing the sentences were analyzed. The imperative politeness was expressed grammatically and lexically. Grammatically, the grammatical politeness was shown by passivizing the verb, shifting moods, and

  18. The effects of reducing worry in patients with persecutory delusions: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Daniel

    2012-11-01

    Full Text Available Abstract Background Our approach to advancing the treatment of psychosis is to focus on key single symptoms and develop interventions that target the mechanisms that maintain them. In our theoretical research we have found worry to be an important factor in the development and maintenance of persecutory delusions. Worry brings implausible ideas to mind, keeps them there, and makes the experience distressing. Therefore the aim of the trial is to test the clinical efficacy of a cognitive-behavioral intervention for worry for patients with persecutory delusions and determine how the worry treatment might reduce delusions. Methods/Design An explanatory randomized controlled trial - called the Worry Intervention Trial (WIT - with 150 patients with persecutory delusions will be carried out. Patients will be randomized to the worry intervention in addition to standard care or to standard care. Randomization will be carried out independently, assessments carried out single-blind, and therapy competence and adherence monitored. The study population will be individuals with persecutory delusions and worry in the context of a schizophrenia spectrum diagnosis. They will not have responded adequately to previous treatment. The intervention is a six-session cognitive-behavioral treatment provided over eight weeks. The control condition will be treatment as usual, which is typically antipsychotic medication and regular appointments. The principal hypotheses are that a worry intervention will reduce levels of worry and that it will also reduce the persecutory delusions. Assessments will be carried out at 0 weeks (baseline, 8 weeks (post treatment and 24 weeks (follow-up. The statistical analysis strategy will follow the intention-to-treat principle and involve the use of linear mixed models to evaluate and estimate the relevant between- and within-subjects effects (allowing for the possibility of missing data. Both traditional regression and newer instrumental

  19. Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: A randomized placebo-controlled pilot study

    Directory of Open Access Journals (Sweden)

    Sen Ananda

    2011-09-01

    Full Text Available Abstract Background Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. Methods We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. Results There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST, sleep efficiency, sleep latency, wake after sleep onset (WASO, sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to Conclusion Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions. Trial Registration ClinicalTrials.gov Identifier NCT01286324

  20. Challenges with participant reimbursement: experiences from a post-trial access study.

    Science.gov (United States)

    Mngadi, Kathryn Therese; Frohlich, Janet; Montague, Carl; Singh, Jerome; Nkomonde, Nelisiwe; Mvandaba, Nomzamo; Ntombeka, Fanelesibonge; Luthuli, Londiwe; Abdool Karim, Quarraisha; Mansoor, Leila

    2015-11-01

    Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation science may necessitate new strategies and models. CAPRISA 008, a post-trial access study testing the feasibility of using family planning services to rollout a prelicensure HIV prevention intervention, tried to balance the real-life scenario of no reimbursement for attendance at public sector clinics with that of a trial including some visits that focused on research procedures and others that focused on standard of care procedures. A reduced reimbursement was offered for 'standard of care' visits, meant primarily to cover transport costs to and from the clinic only. This impacted negatively on accrual, retention and participant morale, primarily due to the protracted delay in regulatory approval, during which time, the costs of living, including travel costs had increased. Relevant guidelines were reviewed and institutional policy was updated to incorporate the South African National Health Research Ethics Committee guidelines on reimbursement (taking into account participant time, travel and inconvenience). The reimbursement amount for 'standard of care' visits was increased accordingly. The question remains whether a trial that combines post-trial access with implementation science, with clear benefits for the participants and the provision of above standard medical care, should have reimbursement rates that approach those of a proof-of-concept trial, for 'standard of care' visits. 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/

  1. Xuebijing injection in the treatment of severe pneumonia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wang, Ping; Song, Yuanlin; Liu, Zhi; Wang, Hui; Zheng, Wenke; Liu, Si; Feng, Zhiqiao; Zhai, Jingbo; Yao, Chen; Ren, Ming; Bai, Chunxue; Shang, Hongcai

    2016-03-17

    Severe pneumonia (SP) is a major complication of respiratory system diseases that is associated with high mortality and morbidity. If not treated correctly, it may rapidly lead to sepsis and multiple organ dysfunction syndrome. Despite continuous developments in antibiotic treatments for SP, the mortality rate remains high. Both basic and clinical research show that Xuebijing injection (XBJ) can improve the symptoms of SP. The aim of this study is to evaluate the effectiveness and safety of XBJ compared with placebo. This multicenter, blinded, randomized controlled trial will be conducted with a total of 700 participants with SP. Using a central randomization system, participants will be randomized (1:1) into groups receiving either XBJ or placebo (within 24 h of diagnosis of SP) for 5-7 days with a 28-day follow-up. All participants will receive conventional treatment simultaneously. Both XBJ and placebo will be administered using a photophobic infusion set to avoid bias. The primary outcome is improvement of Pneumonia Severity Index risk rate. Adverse events will be monitored throughout the trial. This is the first and largest randomized trial done in China on SP treatment using a Chinese herbal extract. In this trial, we will use central randomization and an electronic case report form, and we have designed an innovative blinding method for the traditional Chinese medicine injection. The results of this trial may help to provide evidence-based recommendations to clinicians for treatment of SP. Chinese Clinical Trials Registry ChiCTR-TRC-13003534 . Registered 24 June 2013.

  2. The Feasibility of Administering a Practical Clinical Examination in Podiatry at a College of Podiatric Medicine: Results of a Field Trial Under Simulated Part III Test Conditions.

    Science.gov (United States)

    And Others; Valletta, Michael

    1978-01-01

    The results of a practical clinical examination in podiatric medicine administered to fourth-year students are presented. The examination could become the prototype of a Part III practical clinical examination under the auspices of the National Board of Podiatry Examiners. Its feasibility is established and problems and issues are discussed.…

  3. Telephone-based health coaching for chronically ill patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Dwinger, Sarah; Dirmaier, Jörg; Herbarth, Lutz; König, Hans-Helmut; Eckardt, Matthias; Kriston, Levente; Bermejo, Isaac; Härter, Martin

    2013-10-17

    The rising prevalence of chronic conditions constitutes a major burden for patients and healthcare systems and is predicted to increase in the upcoming decades. Improving the self-management skills of patients is a strategy to steer against this burden. This could lead to better outcomes and lower healthcare costs. Health coaching is one method for enhancing the self-management of patients and can be delivered by phone. The effects of telephone-based health coaching are promising, but still inconclusive. Economic evaluations and studies examining the transferability of effects to different healthcare systems are still rare. Aim of this study is to evaluate telephone-based health coaching for chronically ill patients in Germany. The study is a prospective randomized controlled trial comparing the effects of telephone-based health coaching with usual care during a 4-year time period. Data are collected at baseline and after 12, 24 and 36 months. Patients are selected based on one of the following chronic conditions: diabetes, coronary artery disease, asthma, hypertension, heart failure, COPD, chronic depression or schizophrenia. The health coaching intervention is carried out by trained nurses employed by a German statutory health insurance. The frequency and the topics of the health coaching are manual-based but tailored to the patients' needs and medical condition, following the concepts of motivational interviewing, shared decision-making and evidence-based-medicine. Approximately 12,000 insurants will be enrolled and randomized into intervention and control groups. Primary outcome is the time until hospital readmission within two years after enrolling in the health coaching, assessed by routine data. Secondary outcomes are patient-reported outcomes like changes in quality of life, depression and anxiety and clinical values assessed with questionnaires. Additional secondary outcomes are further economic evaluations like health service use as well as costs and

  4. Clinical effect of catgut implantation at acupoints for allergic rhinitis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Li, Xinrong; Zhang, Qinxiu; Jiang, Luyun; Li, Tao; Liu, Min; Liu, Huanxing; Wang, Xiaopei; Zhang, Fubing

    2013-01-10

    Catgut implantation at acupoints has been used in China to treat allergic rhinitis (AR) for a long time. However, its efficacy and safety in the treatment of AR is controversial due to the poor quality of the clinical trial of this therapy. This study aims to identify whether catgut implantation at acupoints is indeed an effective and safe treatment for patients with persistent or intermittent allergic rhinitis (PER or IAR) by comparing with sham catgut implantation treatment. This study compares real versus sham catgut implantation at acupoints in 242 patients with a history of PER or IAR and with a positive skin prick test (SPT). The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, patients will be randomly assigned by computer-generated randomization list into two groups and assessed prior to treatment. Then, they will receive two sessions of treatments (once per 2 weeks) for 4 consecutive weeks and have a follow-up phase of 12 weeks. The administration of catgut implantation (or sham-control) at acupoints follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series No.15, 1995), and is performed double-blindly by a well-trained physician in acupuncture. The main outcome measures include the primary and secondary indicators. Primary indicators are subjective symptoms scores evaluated by visual analogue scales (VAS) and Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ). The secondary indicators are the results of laboratory examinations, such as serum allergen-specific IgE, nasal inflammatory cells counts (mast cells, eosinophils, and T cells) and nitric oxide concentration in nasal excretion. The use of anti-allergic medication will also be recorded as one of the secondary indicators. Furthermore, adverse events will be recorded and analyzed. If any participants withdraw from the trial, intention-to-treat analysis (ITT) and per

  5. Psoriasis and wound healing outcomes: A retrospective cohort study examining wound complications and antibiotic use.

    Science.gov (United States)

    Young, Paulina M; Parsi, Kory K; Schupp, Clayton W; Armstrong, April W

    2017-11-15

    Little is known about wound healing in psoriasis. We performed a cohort study examining differences in wound healing complications between patients with and without psoriasis. Psoriasis patients with traumatic wounds were matched 1:3 to non-psoriasis patients with traumatic wounds based on age, gender, and body mass index (BMI). We examined theincidence of wound complications including infection, necrosis, and hematoma as well as incident antibiotic use within three months following diagnosis of a traumatic wound. The study included 164 patients with traumatic wounds, comprised of 41 patients with psoriasis matched to 123 patients without psoriasis. No statistically significant differences were detected in the incidence of overall wound complications between wound patients with psoriasis and wound patients without psoriasis (14.6% versus. 13.0%, HR 1.18, CI 0.39-3.56). After adjustment for diabetes, peripheral vascular disease, and smoking, no statistically significant differences were detected in the incidence of overall wound complications between patients with and without psoriasis (HR 1.11, CI 0.34-3.58). Specifically, the adjusted rates of antibiotic use were not significantly different between those with and without psoriasis (HR 0.65, CI 0.29-1.46). The incidence of wound complications following traumatic wounds of the skin was found to be similar between patients with and without psoriasis.

  6. Evaluation of radiation dose in pediatric head CT examination: a phantom study

    Science.gov (United States)

    Norhasrina Nik Din, Nik; Zainon, Rafidah; Rahman, Ahmad Taufek Abdul

    2018-01-01

    The aim of this study was to evaluate the radiation dose in pediatric head Computed Tomography examination. It was reported that decreasing tube voltage in CT examination can reduce the dose to patients significantly. A head phantom was scanned with dual-energy CT at 80 kV and 120 kV. The tube current was set using automatic exposure control mode and manual setting. The pitch was adjusted to 1.4, 1.45 and 1.5 while the slice thickness was set at 5 mm. The dose was measured based on CT Dose Index (CTDI). Results from this study have shown that the image noise increases substantially with low tube voltage. The average dose was 2.60 mGy at CT imaging parameters of 80 kV and 10 - 30 mAs. The dose increases up to 17.19 mGy when the CT tube voltage increases to 120 kV. With the reduction of tube voltage from 120 kV to 80 kV, the radiation dose can be reduced by 12.1% to 15.1% without degradation of contrast-to-noise ratio.

  7. Effects of digital Cognitive Behavioural Therapy for Insomnia on cognitive function: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Kyle, Simon D; Hurry, Madeleine E D; Emsley, Richard; Luik, Annemarie I; Omlin, Ximena; Spiegelhalder, Kai; Espie, Colin A; Sexton, Claire E

    2017-06-17

    The daytime effects of insomnia pose a significant burden to patients and drive treatment seeking. In addition to subjective deficits, meta-analytic data show that patients experience reliable objective impairments across several cognitive domains. While Cognitive Behavioural Therapy for Insomnia (CBT-I) is an effective and scalable treatment, we know little about its impact upon cognitive function. Trials of CBT-I have typically used proxy measures for cognitive functioning, such as fatigue or work performance scales, and no study has assessed self-reported impairment in cognitive function as a primary outcome. Moreover, only a small number of studies have assessed objective cognitive performance, pre-to-post CBT-I, with mixed results. This study specifically aims to (1) investigate the impact of CBT-I on cognitive functioning, assessed through both self-reported impairment and objective performance measures, and (2) examine whether change in sleep mediates this impact. We propose a randomised controlled trial of 404 community participants meeting criteria for Insomnia Disorder. In the DISCO trial (D efining the I mpact of improved S leep on CO gnitive function (DISCO)) participants will be randomised to digital automated CBT-I delivered by a web and/or mobile platform (in addition to treatment as usual (TAU)) or to a wait-list control (in addition to TAU). Online assessments will take place at 0 (baseline), 10 (post-treatment), and 24 (follow-up) weeks. At week 25, all participants allocated to the wait-list group will be offered digital CBT-I, at which point the controlled element of the trial will be complete. The primary outcome is self-reported cognitive impairment at post-treatment (10 weeks). Secondary outcomes include objective cognitive performance, insomnia severity, sleepiness, fatigue, and self-reported cognitive failures and emotional distress. All main analyses will be carried out on completion of follow-up assessments and will be based on the

  8. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

    OpenAIRE

    Cavalcanti, Alexandre B.; Berwanger, Otavio; Suzumura, Erica A.; Amato, Marcelo B. P.; Tallo, Fernando S.; Rezende, Ederlon A. C.; Telles, Jose M. M.; Romano, Edson; Guimaraes, Helio P.; Regenga, Marisa M.; Takahashi, Luzia N.; Teixeira, Cassiano; Oliveira, Roselaine P.; Carvalho, Vitor O.; Diaz-Quijano, Fredi A.

    2012-01-01

    Background Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design ART is a pragmatic, multicenter...

  9. Re-examining minimal luminal diameter relocation and quantitative coronary angiography - Intravascular ultrasound correlations in stented saphenous vein grafts: Methodological insights from the randomised RRISC trial

    NARCIS (Netherlands)

    O. Semeraro (Oscar); P. Agostoni (Pierfrancesco); S. Verheye (Stefan); G.J.J. van Langenhove (Glenn); P.A. van den Heuvel (Paul); C. Convens (Carl); F. van den Branden (Frank); N. Bruining (Nico); P. Vermeersch (Paul)

    2009-01-01

    textabstractAims: Angiographic parameters (such as late luminal loss) are common endpoints in drug-eluting stent trials, but their correlation with the neointimal process and their reliability in predicting restenosis are debated. Methods and results: Using quantitative coronary angiography (QCA)

  10. The Women's international study of long-duration oestrogen after menopause (WISDOM: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meade Tom W

    2007-02-01

    Full Text Available Abstract Background At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. Design Randomised, placebo, controlled, trial. Methods The trial was set in general practices in the UK (384, Australia (94, and New Zealand (24. In these practices 284175 women aged 50–69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 – 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. Results

  11. The Women's international study of long-duration oestrogen after menopause (WISDOM): a randomised controlled trial.

    Science.gov (United States)

    Vickers, Madge R; Martin, Jeannett; Meade, Tom W

    2007-02-26

    At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. Randomised, placebo, controlled, trial. The trial was set in general practices in the UK (384), Australia (94), and New Zealand (24). In these practices 284175 women aged 50-69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 - 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. The trial was prematurely closed during recruitment following

  12. TOGAF 9 foundation study guide preparation for the TOGAF 9 part 1 examination

    CERN Document Server

    Harrison, Rachel

    2013-01-01

    This title is a Study Guide for Togaf® 9 Foundation. It gives an overview of every learning objective for the Togaf 9 Foundation Syllabus and in-depth coverage on preparing and taking the Togaf 9 Part 1 Examination. It is specifically designed to help individuals prepare for certification. This Study Guide is excellent material for: * Individuals who require a basic understanding of Togaf 9; * Professionals who are working in roles associated with an architecture project such as those responsible for planning, execution, development, delivery, and operation; * Architects who are looking for a first introduction to Togaf 9; * Architects who want to achieve Level 2 certification in a stepwise manner and have not previously qualified as Togaf 8 Certified. A prior knowledge of enterprise architecture is advantageous but not required.

  13. Examining Procrastination Across Multiple Goal Stages: A Longitudinal Study of Temporal Motivation Theory

    Directory of Open Access Journals (Sweden)

    Piers Steel

    2018-04-01

    Full Text Available Procrastination is among the most common of motivational failures, putting off despite expecting to be worse off. We examine this dynamic phenomenon in a detailed and realistic longitudinal design (Study 1 as well as in a large correlational data set (N = 7400; Study 2. The results are largely consistent with temporal motivation theory. People’s pacing style reflects a hyperbolic curve, with the steepness of the curve predicted by self-reported procrastination.