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Sample records for non-randomized controlled trials

  1. Evidence for non-random sampling in randomised, controlled trials by Yuhji Saitoh.

    Science.gov (United States)

    Carlisle, J B; Loadsman, J A

    2017-01-01

    A large number of randomised trials authored by Yoshitaka Fujii have been retracted, in part as a consequence of a previous analysis finding a very low probability of random sampling. Dr Yuhji Saitoh co-authored 34 of those trials and he was corresponding author for eight of them. We found a number of additional randomised, controlled trials that included baseline data, with Saitoh as corresponding author, that Fujii did not co-author. We used Monte Carlo simulations to analyse the baseline data from 32 relevant trials in total as well as an outcome (muscle twitch recovery ratios) reported in several. We also compared a series of muscle twitch recovery graphs appearing in a number of Saitoh's publications. The baseline data in 14/32 randomised, controlled trials had p sampling. Combining the continuous and categorical probabilities of the 32 included trials, we found a very low likelihood of random sampling: p = 1.27 × 10(-8) (1 in 100,000,000). The high probability of non-random sampling and the repetition of lines in multiple graphs suggest that further scrutiny of Saitoh's work is warranted. © 2016 The Association of Anaesthetists of Great Britain and Ireland.

  2. Outcome of Percutaneous Release of Tennis Elbow: A Non-Randomized Controlled Trial Study

    Science.gov (United States)

    Khatri, Kishor; Kharel, Krishna; Byanjankar, Subin; Shrestha, Rahul; Sharma, Jay R; Vaishya, Raju; Agarwal, Amit kumar; Vijay, Vipul

    2017-01-01

    Background Tennis elbow is a common disorder of the upper extremity. It can be treated conservatively in the majority of patients, but some resistant cases eventually can be treated by percutaneous release with good functional outcome. Materials and methods This non-randomized control trial was conducted at the Department of Orthopaedics Surgery in a tertiary care hospital from July 2015 to June 2016 on 50 patients who underwent percutaneous release of the common extensor origin using an 18 gauge hypodermic needle. These patients did not respond to conservative treatment including rest, nonsteroidal anti-inflammatory drugs (NSAIDS) and local steroid injections. The outcome was graded as Excellent, Good, Fair, and Poor. Results Fifty patients (50 elbows) were included in the study. Thirty-two patients were female (64%), and 18 were male (36%). The right side was affected in 37 patients (74%) and left side in 13 (26%). The time taken to achieve a completely pain-free elbow ranged from one day to two months (average of 26.2 days). Those who did not achieve a pain-free elbow had a residual pain of 1.5 to six on the visual analogue scale (VAS) (average 2.32). Excellent outcome was noticed in 24 patients (48%); Good result in eight patients (36% ); Fair in four patients (eight percent) and Poor in four patients (eight percent). Conclusion Tennis elbow probably results from the degenerative tear of the common extensor origin, and a percutaneous tenotomy using an 18 gauge hypodermic needle is a simple, safe, patient-friendly, efficient, and easily reproducible method of treating tennis elbow in those who are resistant to conservative treatment, and it can be done as an outpatient procedure. PMID:28168130

  3. The NARCONON™ drug education curriculum for high school students: A non-randomized, controlled prevention trial

    OpenAIRE

    Cecchini Marie A; Lennox Richard D

    2008-01-01

    Abstract Background An estimated 13 million youths aged 12 to 17 become involved with alcohol, tobacco and other drugs annually. The number of 12- to 17-year olds abusing controlled prescription drugs increased an alarming 212 percent between 1992 and 2003. For many youths, substance abuse precedes academic and health problems including lower grades, higher truancy, drop out decisions, delayed or damaged physical, cognitive, and emotional development, or a variety of other costly consequences...

  4. The NARCONON™ drug education curriculum for high school students: A non-randomized, controlled prevention trial

    Directory of Open Access Journals (Sweden)

    Cecchini Marie A

    2008-03-01

    Full Text Available Abstract Background An estimated 13 million youths aged 12 to 17 become involved with alcohol, tobacco and other drugs annually. The number of 12- to 17-year olds abusing controlled prescription drugs increased an alarming 212 percent between 1992 and 2003. For many youths, substance abuse precedes academic and health problems including lower grades, higher truancy, drop out decisions, delayed or damaged physical, cognitive, and emotional development, or a variety of other costly consequences. For thirty years the Narconon program has worked with schools and community groups providing single educational modules aimed at supplementing existing classroom-based prevention activities. In 2004, Narconon International developed a multi-module, universal prevention curriculum for high school ages based on drug abuse etiology, program quality management data, prevention theory and best practices. We review the curriculum and its rationale and test its ability to change drug use behavior, perceptions of risk/benefits, and general knowledge. Methods After informed parental consent, approximately 1000 Oklahoma and Hawai'i high school students completed a modified Center for Substance Abuse Prevention (CSAP Participant Outcome Measures for Discretionary Programs survey at three testing points: baseline, one month later, and six month follow-up. Schools assigned to experimental conditions scheduled the Narconon curriculum between the baseline and one-month follow-up test; schools in control conditions received drug education after the six-month follow-up. Student responses were analyzed controlling for baseline differences using analysis of covariance. Results At six month follow-up, youths who received the Narconon drug education curriculum showed reduced drug use compared with controls across all drug categories tested. The strongest effects were seen in all tobacco products and cigarette frequency followed by marijuana. There were also significant

  5. Effectiveness of a 'Global Postural Reeducation' program for persistent Low Back Pain: a non-randomized controlled trial

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    Violante Francesco S

    2010-12-01

    Full Text Available Abstract Background The aim of this non-randomized controlled trial was to evaluate the effectiveness of a Global Postural Reeducation (GPR program as compared to a Stabilization Exercise (SE program in subjects with persistent low back pain (LBP at short- and mid-term follow-up (ie. 3 and 6 months. Methods According to inclusion and exclusion criteria, 100 patients with a primary complaint of persistent LBP were enrolled in the study: 50 were allocated to the GPR group and 50 to the SE group. Primary outcome measures were Roland and Morris Disability Questionnaire (RMDQ and Oswestry Disability Index (ODI. Secondary outcome measures were lumbar Visual Analogue Scale (VAS and Fingertip-to-floor test (FFT. Data were collected at baseline and at 3/6 months by health care professionals unaware of the study. An intention to treat approach was used to analyze participants according to the group to which they were originally assigned. Results Of the 100 patients initially included in the study, 78 patients completed the study: 42 in the GPR group and 36 in the SE group. At baseline, the two groups did not differ significantly with respect to gender, age, BMI and outcome measures. Comparing the differences between groups at short- and mid-term follow-up, the GPR group revealed a significant reduction (from baseline in all outcome measures with respect to the SE group. The ordered logistic regression model showed an increased likelihood of definitive improvement (reduction from baseline of at least 30% in RMDQ and VAS scores for the GPR group compared to the SE group (OR 3.9, 95% CI 2.7 to 5.7. Conclusions Our findings suggest that a GPR intervention in subjects with persistent LBP induces a greater improvement on pain and disability as compared to a SE program. These results must be confirmed by further studies with higher methodological standards, including randomization, larger sample size, longer follow-up and subgrouping of the LBP subjects. Trial

  6. A non-randomized [corrected] controlled trial of the active music engagement (AME) intervention on children with cancer.

    Science.gov (United States)

    Robb, Sheri L; Clair, Alicia A; Watanabe, Masayo; Monahan, Patrick O; Azzouz, Faouzi; Stouffer, Janice W; Ebberts, Allison; Darsie, Emily; Whitmer, Courtney; Walker, Joey; Nelson, Kirsten; Hanson-Abromeit, Deanna; Lane, Deforia; Hannan, Ann

    2008-07-01

    Coping theorists argue that environmental factors affect how children perceive and respond to stressful events such as cancer. However, few studies have investigated how particular interventions can change coping behaviors. The active music engagement (AME) intervention was designed to counter stressful qualities of the in-patient hospital environment by introducing three forms of environmental support. The purpose of this multi-site randomized controlled trial was to determine the efficacy of the AME intervention on three coping-related behaviors (i.e. positive facial affect, active engagement, and initiation). Eighty-three participants, ages 4-7, were randomly assigned to one of three conditions: AME (n = 27), music listening (ML; n = 28), or audio storybooks (ASB; n = 28). Conditions were videotaped to facilitate behavioral data collection using time-sampling procedures. After adjusting for baseline differences, repeated measure analyses indicated that AME participants had a significantly higher frequency of coping-related behaviors compared with ML or ASB. Positive facial affect and active engagement were significantly higher during AME compared with ML and ASB (p<0.0001). Initiation was significantly higher during AME than ASB (p<0.05). This study supports the use of the AME intervention to encourage coping-related behaviors in hospitalized children aged 4-7 receiving cancer treatment. (c) 2007 John Wiley & Sons, Ltd.

  7. Botulinum toxin injection versus lateral internal sphincterotomy in the treatment of chronic anal fissure: a non-randomized controlled trial

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    Ulusoy Nefise B

    2004-03-01

    Full Text Available Abstract Background Although lateral internal sphincterotomy is the gold-standard treatment for chronic anal fissure, intrasphincteric injection of botulinum toxin seems to be a reliable new option. The aim of this non-randomized study is to compare the effect of lateral internal sphincterotomy and botulinum toxin injection treatments on the outcome and reduction of anal sphincter pressures in patients with chronic anal fissure. Methods Patients with chronic anal fissure were treated with either botulinum toxin injection or lateral internal sphincterotomy by their own choice. Maximal resting pressure and maximal squeeze pressure measurements were performed before and 2 weeks after treatments by anal manometry. Patients were followed for fissure relapse during 14 months. Results Twenty-one consecutive outpatients with posterior chronic anal fissure were enrolled. Eleven patients underwent surgery and ten patients received botulinum toxin injection treatment. Before the treatment, anal pressures were found to be similar in both groups. After the treatment, the maximal resting pressures were reduced from 104 ± 22 mmHg to 86 ± 15 mmHg in the surgery group (p 0.05 in the surgery group, and from 117 ± 62 mmHg to 76 ± 34 (p 0.05. There were no relapses during the 14 months of follow up. Conclusion Lateral internal sphincterotomy and botulinum toxin injection treatments both seem to be equally effective in the treatment of chronic anal fissure.

  8. Effective Group Training for Patients with Unexplained Physical Symptoms: A Randomized Controlled Trial with a Non-Randomized One-Year Follow-Up

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    Zonneveld, Lyonne N. L.; van Rood, Yanda R.; Timman, Reinier; Kooiman, Cornelis G.; van't Spijker, Adriaan; Busschbach, Jan J. V.

    2012-01-01

    Background Although cognitive-behavioral therapy for Unexplained Physical Symptoms (UPS) is effective in secondary care, studies done in primary care produced implementation problems and conflicting results. We evaluated the effectiveness of a cognitive-behavioral group training tailored to primary care patients and provided by a secondary community mental-health service reaching out into primary care. Methodology/Principal Findings The effectiveness of this training was explored in a randomized controlled trial. In this trial, 162 patients with UPS classified as undifferentiated somatoform disorder or as chronic pain disorder were randomized either to the training or a waiting list. Both lasted 13 weeks. The preservation of the training's effect was analyzed in non-randomized follow-ups, for which the waiting group started the training after the waiting period. All patients attended the training were followed-up after three months and again after one year. The primary outcomes were the physical and the mental summary scales of the SF-36. Secondary outcomes were the other SF-36-scales and the SCL-90-R. The courses of the training's effects in the randomized controlled trial and the follow-ups were analyzed with linear mixed modeling. In the randomized controlled trial, the training had a significantly positive effect on the quality of life in the physical domain (Cohen's d = 0.38;p = .002), but this overall effect was not found in the mental domain. Regarding the secondary outcomes, the training resulted in reporting an improved physical (Cohen's d = 0.43;p = 0.01), emotional (Cohen's d = 0.44;p = .0.01), and social (Cohen's d = 0.36;p = 0.01) functioning, less pain and better functioning despite pain (Cohen's d = 0.51;p =  PMID:22880056

  9. Effective group training for patients with unexplained physical symptoms: a randomized controlled trial with a non-randomized one-year follow-up.

    Directory of Open Access Journals (Sweden)

    Lyonne N L Zonneveld

    Full Text Available BACKGROUND: Although cognitive-behavioral therapy for Unexplained Physical Symptoms (UPS is effective in secondary care, studies done in primary care produced implementation problems and conflicting results. We evaluated the effectiveness of a cognitive-behavioral group training tailored to primary care patients and provided by a secondary community mental-health service reaching out into primary care. METHODOLOGY/PRINCIPAL FINDINGS: The effectiveness of this training was explored in a randomized controlled trial. In this trial, 162 patients with UPS classified as undifferentiated somatoform disorder or as chronic pain disorder were randomized either to the training or a waiting list. Both lasted 13 weeks. The preservation of the training's effect was analyzed in non-randomized follow-ups, for which the waiting group started the training after the waiting period. All patients attended the training were followed-up after three months and again after one year. The primary outcomes were the physical and the mental summary scales of the SF-36. Secondary outcomes were the other SF-36-scales and the SCL-90-R. The courses of the training's effects in the randomized controlled trial and the follow-ups were analyzed with linear mixed modeling. In the randomized controlled trial, the training had a significantly positive effect on the quality of life in the physical domain (Cohen's d = 0.38;p = .002, but this overall effect was not found in the mental domain. Regarding the secondary outcomes, the training resulted in reporting an improved physical (Cohen's d = 0.43;p = 0.01, emotional (Cohen's d = 0.44;p = 0.01, and social (Cohen's d = 0.36;p = 0.01 functioning, less pain and better functioning despite pain (Cohen's d = 0.51;p =

  10. Interventions for Preventing Childhood Obesity with Smartphones and Wearable Device: A Protocol for a Non-Randomized Controlled Trial.

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    Yang, Hye Jung; Kang, Jae-Heon; Kim, Ok Hyun; Choi, Mona; Oh, Myungju; Nam, Jihyun; Sung, Eunju

    2017-02-13

    Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named "HAPPY ME," which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10-12 years of age using HAPPY ME. A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference), body mass index (BMI) percentiles (obesity rate), and psychological perceptions among participants. The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach.

  11. Interventions for Preventing Childhood Obesity with Smartphones and Wearable Device: A Protocol for a Non-Randomized Controlled Trial

    Science.gov (United States)

    Yang, Hye Jung; Kang, Jae-Heon; Kim, Ok Hyun; Choi, Mona; Oh, Myungju; Nam, Jihyun; Sung, Eunju

    2017-01-01

    Background: Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named “HAPPY ME,” which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10–12 years of age using HAPPY ME. Methods: A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference), body mass index (BMI) percentiles (obesity rate), and psychological perceptions among participants. Conclusions: The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach. PMID:28208839

  12. Interventions for Preventing Childhood Obesity with Smartphones and Wearable Device: A Protocol for a Non-Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hye Jung Yang

    2017-02-01

    Full Text Available Background: Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named “HAPPY ME,” which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10–12 years of age using HAPPY ME. Methods: A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference, body mass index (BMI percentiles (obesity rate, and psychological perceptions among participants. Conclusions: The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach.

  13. Efficacy of Health Education using Facebook to Promote Healthy Lifestyle among Medical Students in Puducherry, India: A Non-Randomized Controlled Trial.

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    Krishnamohan, Smrithi; Stalin, P; Singh, Zile; Sridhar, Maghida

    2017-07-01

    Increasing burden of overweight and obesity among young adults is mainly due to unhealthy lifestyle especially with respect to diet and physical activity. At the same time, younger generations are spending more time with social network sites. Therefore, this study was intended to explore the role of social networking sites in promoting healthy lifestyle. To measure the efficacy of health education using social networking sites in promoting healthy lifestyle among medical students in Puducherry, India. A non-randomized controlled trial was conducted in a private medical college located in Puducherry. The study participants were overweight/obese individuals with (intervention arm) and without Facebook account (control arm). Following a baseline survey, both the groups received health education from dietician and physical trainer using Audiovisual (AV) aids. Intervention group received health education through Facebook in the forms of messages, pictures and videos for six weeks. Then, follow up survey was done to assess the change in dietary pattern, physical activity and body weight. Data of those who attended baseline, intervention and follow up surveys (23- control and 22- intervention) were analysed. Means and proportions were calculated. Paired t-test and Chi-square test were used to calculate the p-value. The p-valuejunk food intake per week was reduced in both control and intervention groups from 2.91 days/week and 3.27 days/week at baseline to 2.65 days/week to two days/week at follow up respectively. A significant decrease in the Body Mass Index (BMI) (pactivity and intake of fruits and vegetables. Except for the decrease in junk food intake, use of Facebook as an effective tool to promote healthy lifestyle could not be proved with confidence.

  14. Effect of cognitive behavioral group therapy for recovery of self-esteem on community-living individuals with mental illness: Non-randomized controlled trial.

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    Kunikata, Hiroko; Yoshinaga, Naoki; Nakajima, Kazuo

    2016-10-01

    The aim of this study was to examine over a 12-month post-intervention period whether the participation of community-living individuals with mental illness in cognitive behavioral group therapy for recovery of self-esteem (CBGTRS) resulted in improved outcomes. This was a non-randomized controlled trial. The participants were persons with mental illness who resided in communities in the Chugoku region of Japan. In total, 41 were assigned to an experimental group (CBGTRS intervention, 12 group sessions), and 21 to a control group. Outcome indices (self-esteem, moods, cognition, subjective well-being, psychiatric symptoms) were measured for the experimental group prior to intervention (T0), immediately post-intervention (T1), and at 3 (T2) and 12 (T3) months post-intervention. The control group was measured at the same intervals. For the experimental group, self-esteem scores at T1, T2, and T3 were significantly higher than at T0. Moods and cognition scores remained significantly low until T2. Scores for Inadequate Mental Mastery in the subjective well-being index had not decreased by T3. Confidence in Coping remained significantly high until T2. Psychiatric symptoms scores at T0, T1, T2, and T3 were significantly lower than at T0. The means and standard errors for self-esteem and Inadequate Mental Mastery increased until T3, and those for Tension-Anxiety, Depression-Dejection, and Confusion decreased until T2. From within-group trends and between-group differences in self-esteem, we conclude that CBGTRS may have a relatively long-term effect on self-esteem recovery. T2 is the turning point for moods and cognition; thus, follow-up is needed 3 months following the initial program. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

  15. Evaluation of an advanced pressure ulcer management protocol followed by trained wound, ostomy, and continence nurses: a non-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kaitani T

    2015-02-01

    Full Text Available Toshiko Kaitani,1 Gojiro Nakagami,2 Junko Sugama,3 Masahiro Tachi,4 Yutaka Matsuyama,5 Yoshiki Miyachi,6 Takashi Nagase,2 Yukie Takemura,7 Hiromi Sanada2 1School of Nursing, Sapporo City University, Hokkaido, Japan; 2Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 3Department of Clinical Nursing, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan; 4Department of Plastic Surgery, Tohoku University Graduate School of Medicine, Miyagi, Japan; 5Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 6Department of Dermatology, Kyoto University Graduate School of Medicine, Kyoto, Japan; 7Department of Nursing, Research Hospital, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan Aims and objectives: We investigated the effectiveness and safety of an advanced pressure ulcer (PU management protocol comprising 1 ultrasonography to assess the deep tissue, 2 use of a non-contact thermometer to detect critical colonization, 3 conservative sharp debridement, 4 dressing selection, 5 negative pressure wound therapy, and 6 vibration therapy in comparison with those of a conventional approach. Each protocol was followed by trained wound, ostomy, and continence nurses (WOCNs. Background: At present, there is no systematic PU management protocol for nurses that includes appropriate assessment and intervention techniques for deep tissue injury and critical colonization. In Japan, there is no such protocol that the nurses can follow without a physician’s orders. Design and methods: This was a prospective non-randomized controlled trial. Over a 3-week period, we evaluated the effectiveness of an advanced protocol by comparing the PU severity and healing on the basis of the DESIGN-R scale and presence of patients' discomfort. We recruited ten WOCNs to follow

  16. Effect of post-stroke sensory disorders on the recovery processes of motor function and activity of daily living A non-randomized synchroniesl controlled trial

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    BACKGROUND:In the rehabilitation of stroke patients,clinicians usually concentrate on motor problems,such as spasm of limbs and restriction of joint motion,while sensory and perceptive problems are almost always neglected,although they are just as important.One such area is the sensory disorder. OBJECTIVE:To evaluate the motor function and activities of daily living in stroke patients with and without sensory disorders after treatment of integrated western and Chinese medicine.DESIGN:A non-randomized synchronically controlled trial.SETTING:First Affiliated Hospital of Tianjin College of Traditional Chinese Medicine.PARTICIPANTS:Totally 500 stroke inpatients were selected from the Department of Acupuncture and Massage,the First Affiliated Hospital of Tianjin College of Traditional Chinese Medicine from January 2003 to December 2004.They all had suffered from stroke in the last 4 weeks and accompanied by sensory disorder of the ipsilateral limb to different severity.The patients were all accorded with the Diagnostic and Efficacy Evaluative Standards for Stroke (in trial)set by the Encephalopathy Emergency Assistant Group,the State Administration of Traditional Chinese Medicine in 1995,and they were diagnosed by imaging examination.The patients were stratified into sensory disorder group (n =220) and normal sense group (n=280).Informed consent for the detected items and therapeutic program was obtained from the relatives of all the participants.The study was approved by the hospital ethical committee.METHODS:All the patients were treated with acupuncture of Xing Nao Kai Qiao for restoring consciousness and inducing resuscitation,assisted by traditional Chinese medicine and western medicine specific to corresponding symptoms.The therapeutic principles were restoring consciousness and inducing resuscitation,nourishing liver and kidney,and dredging meridian.In addition,the patients were given western medical treatments for decreasing intracranial pressure

  17. A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls.

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    Bahamondes, Luis; Brache, Vivian; Meirik, Olav; Ali, Moazzam; Habib, Ndema; Landoulsi, Sihem

    2015-11-01

    Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion, and between implant and intrauterine device (IUD) contraception, in particular complaints possibly related to hormonal contraceptives? The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants, but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users. This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement, follow-ups were at 2 weeks, 3 and 6 months, and semi-annually thereafter for 3 years or until pregnancy, removal or expulsion of the implant/IUD occurred. The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here. ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight

  18. Data fabrication and other reasons for non-random sampling in 5087 randomised, controlled trials in anaesthetic and general medical journals.

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    Carlisle, J B

    2017-08-01

    Randomised, controlled trials have been retracted after publication because of data fabrication and inadequate ethical approval. Fabricated data have included baseline variables, for instance, age, height or weight. Statistical tests can determine the probability of the distribution of means, given their standard deviation and the number of participants in each group. Randomised, controlled trials have been retracted after the data distributions have been calculated as improbable. Most retracted trials have been written by anaesthetists and published by specialist anaesthetic journals. I wanted to explore whether the distribution of baseline data in trials was consistent with the expected distribution. I wanted to determine whether trials retracted after publication had distributions different to trials that have not been retracted. I wanted to determine whether data distributions in trials published in specialist anaesthetic journals have been different to distributions in non-specialist medical journals. I analysed the distribution of 72,261 means of 29,789 variables in 5087 randomised, controlled trials published in eight journals between January 2000 and December 2015: Anaesthesia (399); Anesthesia and Analgesia (1288); Anesthesiology (541); British Journal of Anaesthesia (618); Canadian Journal of Anesthesia (384); European Journal of Anaesthesiology (404); Journal of the American Medical Association (518) and New England Journal of Medicine (935). I chose these journals as I had electronic access to the full text. Trial p values were distorted by an excess of baseline means that were similar and an excess that were dissimilar: 763/5015 (15.2%) trials that had not been retracted from publication had p values that were within 0.05 of 0 or 1 (expected 10%), that is, a 5.2% excess, p = 1.2 × 10(-7) . The p values of 31/72 (43%) trials that had been retracted after publication were within 0.05 of 0 or 1, a rate different to that for unretracted trials, p = 1.03

  19. Does working with the Veder Contact Method influence the job satisfaction of caregivers? A non-randomized controlled trial in nursing homes for people with dementia.

    Science.gov (United States)

    Boersma, P; Dröes, R M; Lissenberg-Witte, B I; van Meijel, B; van Weert, J C M

    2017-08-22

    Person-centered care interventions can improve the quality of life and decrease behavioral problems of people with dementia. Although not convincingly proven, person-centered care interventions may benefit the caregivers as well. This study aims to gain insight into how working with the Veder Contact Method (VCM) - a new person-centered care method - influences the job satisfaction of caregivers. Within a quasi-experimental study, the job satisfaction of caregivers of six experimental wards (n = 75) was compared with caregivers of six control wards (n = 36) that applied Care-As-Usual. The Leiden Quality of Work Questionnaire (LQWQ) was filled in by caregivers in both conditions. Additionally, on the experimental wards, qualitative research, i.e. focus groups with 42 caregivers and interviews with 11 managers, was conducted to obtain a deeper understanding of the influence of applying VCM on caregivers' job satisfaction. The transcripts were analyzed using deductive analysis. No quantitatively significant differences were found on the subscales of the LQWQ: work and time pressure, job satisfaction, autonomous decision making, social support from colleagues, and social support from supervisors. From the qualitative research, some caregivers and managers reported that implementing VCM contributed to their job satisfaction and that applying VCM supported handling difficult behavior and depressed mood of residents and contributed to team building. No significant effects on job satisfaction were demonstrated. Qualitative findings indicate that VCM positively influences the daily work performances of nursing home caregivers. The relation between the experience of offering quality care and job satisfaction of caregivers needs further investigation.

  20. A non-randomized clinical control trial of Harrison mirror image methods for correcting trunk list (lateral translations of the thoracic cage) in patients with chronic low back pain.

    Science.gov (United States)

    Harrison, Deed E; Cailliet, Rene; Betz, Joseph W; Harrison, Donald D; Colloca, Christopher J; Haas, Jason W; Janik, Tadeusz J; Holland, Burt

    2005-03-01

    Spinal trunk list is a common occurrence in clinical practice, but few conservative methods of spinal rehabilitation have been reported. This study is a non-randomized clinical control trial of 63 consecutive retrospective subjects undergoing spinal rehabilitation and 23 prospective volunteer controls. All subjects presented with lateral thoracic-cage-translation posture (trunk list) and chronic low back pain. Initial and follow-up numerical pain rating scales (NRS) and AP lumbar radiographs were obtained after a mean of 11.5 weeks of care (average of 36 visits) for the treatment group and after a mean of 37.5 weeks for the control group. The radiographs were digitized and analyzed for a horizontal displacement of T12 from the second sacral tubercle, verticality of the lumbar spine at the sacral base, and any dextro/levo angle at mid-lumbar spine. Treatment subjects received the Harrison mirror image postural correction methods, which included an opposite trunk-list exercise and a new method of opposite trunk-list traction. Control subjects did not receive spinal rehabilitation therapy, but rather self-managed their back pain. For the treatment group, there were statistically significant improvements (approximately 50%) in all radiographic measurements and a decrease in pain intensity (NRS: 3.0 to 0.8). For the control group, no significant radiographic and NRS differences were found, except in trunk-list displacement of T12 to S1, worsened by 2.4 mm. Mirror image (opposite posture) postural corrective exercises and a new method of trunk-list traction resulted in 50% reduction in trunk list and were associated with nearly resolved pain intensity in this patient population. The findings warrant further study in the conservative treatment of chronic low back pain and spinal disorders.

  1. Mindfulness Training for Health Profession Students-The Effect of Mindfulness Training on Psychological Well-Being, Learning and Clinical Performance of Health Professional Students: A Systematic Review of Randomized and Non-randomized Controlled Trials.

    Science.gov (United States)

    McConville, Janet; McAleer, Rachael; Hahne, Andrew

    High levels of stress have been identified in medical students and increasingly in other health profession student population groups. As stress can affect psychological well-being and interfere with learning and clinical performance, there is a clear argument for universities to include health professional student well-being as an outcome in core curriculum. Mindfulness training is a potential construct to manage stress and enhance academic success. The aims of this systematic review were to assess the effectiveness of mindfulness training in medical and other health professional student population groups and to compare the effectiveness of the different mindfulness-based programs. A literature search was completed using The Cochrane library, Medline, Cinahl, Embase, Psychinfo, and ERIC (proquest) electronic databases from inception to June 2016. Randomized and non-randomized controlled trials were included. Of the potential 5355 articles, 19 met the inclusion criteria. Studies focused on medical (n = 10), nursing (n = 4), social work (n = 1), psychology (n = 1), and medical plus other health (n = 3) students. Interventions were based on mindfulness. The 19 studies included 1815 participants. Meta-analysis was performed evaluating the effect of mindfulness training on mindfulness, anxiety, depression, stress, mood, self-efficacy, and empathy. The effect of mindfulness on academic performance was discussed. Mindfulness-based interventions decrease stress, anxiety, and depression and improve mindfulness, mood, self-efficacy, and empathy in health profession students. Due to the range of presentation options, mindfulness training can be relatively easily adapted and integrated into health professional training programs. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Effectiveness of the “What’s Up!” Intervention to Reduce Stigma and Psychometric Properties of the Youth Program Questionnaire (YPQ: Results from a Cluster Non-randomized Controlled Trial Conducted in Catalan High Schools

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    Laura Andrés-Rodríguez

    2017-09-01

    Full Text Available Mental disorders are highly prevalent in the general population, and people who experience them are frequently stigmatized. Stigma has a very negative impact on social, academic/professional, and personal life. Considering the high rates of mental disorders among children and adolescents (13.4% and how critical this age is in the formation of nuclear beliefs, many campaigns to combat stigma have been developed in the last decade, with mixed results. The OBERTAMENT initiative has produced various anti-stigma campaigns in Catalonia (Spain. In the present study, the main objective was to report on the effectiveness of the OBERTAMENT “What’s up!” intervention, a curricular intervention including education and social contact conducted by the teachers in the classroom with teenagers aged between 14 and 18. Prior to this, we examined the psychometric properties of the Youth Program Questionnaire (YPQ, our main outcome measure, in terms of dimensionality, reliability, and validity. A cluster non-randomized controlled trial was conducted to assess this intervention, which was tested in nine high schools situated in the Barcelona region. A convenience sample of 261 students formed the intervention group and 132 the control group (52% women, mean age = 14, SD = 0.47. The assignment to study conditions was conducted by Departament d’Ensenyament (Department of Education, Generalitat de Catalunya (Catalan Government. Participants were evaluated at baseline, post-intervention, and 9-month follow-up. The main outcome measure of this study was the YPQ. The Reported and Intended Behavior Scale (RIBS was used as secondary outcome measure. The statistical analysis indicated that the YPQ possesses a two-factor structure (stereotypical attitudes and intended behavior and sound psychometric properties. The multilevel mixed-effects models revealed statistically significant interactions for both study measures and post hoc intragroup analyses revealed a

  3. The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent

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    Cristina Lucía Dávila-Fajardo

    2017-02-01

    Full Text Available This article contains data related to the research article entitled “Results of genotype–guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent” (J. Sánchez-Ramos, C.L. Dávila-Fajardo, P. Toledo Frías, X. Díaz Villamarín, L.J. Martínez-González, S. Martínez Huertas, F. Burillo Gómez, J. Caballero Borrego, A. Bautista Pavés, M.C. Marín Guzmán, J.A. Ramirez Hernández, C. Correa Vilches, J. Cabeza Barrera, 2016 (1. This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype–guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up, study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33.

  4. Belonging to a peer support group enhance the quality of life and adherence rate in patients affected by breast cancer: A non-randomized controlled clinical trialFNx01

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    Afsaneh Malekpour Tehrani

    2011-01-01

    Full Text Available Background: Breast cancer is the most common cancer in women. It seems that breast cancer patients benefit from meeting someone who had a similar experience. This study evaluated the effect of two kinds of interventions (peer support and educational program on quality of life in breast cancer patients. Methods: This study was a controlled clinical trial on women with non-metastatic breast cancer. The patients studied in two experimental and control groups. Experimental group took part in peer support program and control group passed a routine educational program during 3 months. The authors administered SF-36 for evaluating the quality of life pre-and post intervention. Also, patient′s adherence was assessed by means of a simple checklist. Results: Two groups were similar with respect of age, age of onset of the disease, duration of having breast cancer, marital status, type of the treatment receiving now, and type of the received surgery. In the control group, there were statistically significant improvements in body pain, role-physical, role-emotional and social functioning. In experimental group, role-physical, vitality, social functioning, role-emotional and mental health showed significant improvement. Vitality score and mental health score in experimental group was significantly higher than that of the control group, both with p < 0.001. Also, it was shown that adherence was in high levels in both groups and no significant difference was seen after the study was done. Conclusions: According to the results of this study, supporting the patients with breast cancer by forming peer groups or by means of educational sessions could improve their life qualities.

  5. Skin-impedance in Fabry Disease: A prospective, controlled, non-randomized clinical study

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    Lidicker Jeffrey R

    2008-11-01

    Full Text Available Abstract Background We previously demonstrated improved sweating after enzyme replacement therapy (ERT in Fabry disease using the thermo-regularity sweat and quantitative sudomotor axon reflex tests. Skin-impedance, a measure skin-moisture (sweating, has been used in the clinical evaluation of burns and pressure ulcers using the portable dynamic dermal impedance monitor (DDIM system. Methods We compared skin impedance measurements in hemizygous patients with Fabry disease (22 post 3-years of bi-weekly ERT and 5 ERT naive and 22 healthy controls. Force compensated skin-moisture values were used for statistical analysis. Outcome measures included 1 moisture reading of the 100th repetitive reading, 2 rate of change, 3 average of 60–110th reading and 4 overall average of all readings. Results All outcome measures showed a significant difference in skin-moisture between Fabry patients and control subjects (p Conclusion The instrument portability, ease of its use, a relatively short time required for the assessment, and the fact that DDIM system was able to detect the difference in skin-moisture renders the instrument a useful clinical tool.

  6. Effectiveness of team-based learning in microbiology: a non-randomized control study.

    Science.gov (United States)

    Harakuni, Sheetal U; Nagamoti, Jyoti M; Mallapur, Maheshwar D

    2015-01-01

    As per the present curriculum in India, pre- and paraclinical subjects are taught away from the clinical setting. Therefore, students fail to connect the subject taught through didactic lectures to the clinical setting. Team-based learning (TBL) can be used in conjunction with lectures to teach applied microbiology. This study aims to evaluate the effectiveness of TBL sessions in conjunction with lectures to enhance learning of applied microbiology, among Indian students. All students enrolled in the study were taught systemic bacteriology through lectures. Of the 88 students, 49 students (study group) attended TBL sessions on the topics of diarrhea, fever of unknown origin, urinary tract infection and 39 students (control group) preferred self-study on the topics without attending the TBL sessions. Students' feedback on their perception on TBL sessions was collected using a questionnaire of 10 items. The performance of both the groups on the pre- and post-test were analyzed using unpaired t-test and analysis of variance (ANOVA). Gender-wise performance within the teams was analyzed by paired t-test using SPSS version 12. The TBL group outperformed the self-study group on the post-test [F 1 = 5.521, P = 0.021]. Female students as a whole performed better than males on the pre-test, scoring higher within both the TBL and self-study groups. Male students in the TBL group performed significantly better on the post-test than female students who participated in TBL sessions (P = 0.013). Students generally enjoyed and appreciated the TBL sessions. TBL sessions can be used judiciously in combination with the lectures to enhance learning of applied microbiology in India. In this study, TBL improved the performance of male students over self-study, but performance for female students following TBL was no better than when they simply studied by themselves.

  7. Effects of an Integrated ‘Fast Track’ Rehabilitation Service for Multi-Trauma Patients: A Non-Randomized Clinical Trial in the Netherlands

    Science.gov (United States)

    Bouman, Ans I. E.; Hemmen, Bea; Evers, Silvia M. A. A.; van de Meent, Henk; Ambergen, Ton; Vos, Pieter E.; Brink, Peter R. G.; Seelen, Henk A. M.

    2017-01-01

    Objectives The effects on health related outcomes of a newly-developed rehabilitation program, called ‘supported Fast Track multi-trauma rehabilitation service’ (Fast Track), were evaluated in comparison with conventional trauma rehabilitation service (Care as Usual). Methods Prospective, multi-center, non-randomized controlled study. Between 2009 and 2012, 132 adult multi-trauma patients were included: 65 Fast Track and 67 Care as Usual patients with an Injury Severity Score ≥16, complex multiple injuries in several extremities or complex pelvic and/or acetabulum fractures. The Fast Track program involved: integrated coordination between trauma surgeon and rehabilitation physician, shorter stay in hospital with faster transfer to a specialized trauma rehabilitation unit, earlier start of multidisciplinary treatment and ‘non-weight bearing’ mobilization. Primary outcomes were functional status (FIM) and quality of life (SF-36) measured through questionnaires at baseline, 3, 6, 9 and 12 months post-trauma. Outcomes were analyzed using a linear mixed-effects regression model. Results The FIM scores significantly increased between 0 and 3 months (p<0.001) for both groups showing that they had improved overall, and continued to improve between 3 and 6 months for Fast Track (p = 0.04) and between 3 and 9 months for Care as Usual (p = 0.03). SF-36 scores significantly improved in both groups between 3 and 6 months (Fast Track, p<0.001; Care as Usual, p = 0.01). At 12 months, SF-36 scores were still below (self-reported) baseline measurements of patient health prior to the accident. However, the FIM and SF-36 scores differed little between the groups at any of the measured time points. Conclusion Both Fast Track and Care as Usual rehabilitation programs were effective in that multi-trauma patients improved their functional status and quality of life. A faster (maximum) recovery in functional status was observed for Fast Track at 6 months compared to 9 months for

  8. Neurotransmitter changes in patients with Parkinson's disease detected by encephalofluctuography technology A non-randomized control study

    Institute of Scientific and Technical Information of China (English)

    Yan Han; Zhenfu Wang; Yang Yang; Xianhong Chen; Hong Sun

    2008-01-01

    BACKGROUND: Encephalofluctuograph Technology (ET) is an advanced and non-traumatic analytical method of brain function. ET can acquire super-slow waves from electroencephalic signals. Studies have shown that these particular spectra can reflect neurochemical processes in the brain. OBJECTIVE: To verify neurotransmitter changes in the brains Parkinson's disease (PD) patients through the use of ET. DESIGN, TIME AND SETTING: A non-randomized concurrent control experiment was performed at the Department of Neurology in Southern Building, General Hospital of Chinese PLA from August to December 2007. PARTICIPANTS: Sixty-one outpatients with PD were selected from the General Hospital of Chinese PLA from August 2007 to December 2007. In addition, 48 healthy subjects were selected as normal controls. METHODS: All patients underwent assessment of the sub scale Ⅱ,Ⅲ, and V of the Unified Parkinson's Disease Rating Scale (UPDRS), in which part Ⅱ was used to inform activity of daily living, part Ⅲ reflected athletic ability, and part Ⅴ was the Hoehn & Yahr grade for symptoms evaluation. Correlation analysis was performed between dopamine levels and UPDRS assessment. Neurotransmitter changes were observed forty-eight prior to and 1.5 hours after medicating with Benserazide. The S1, S2, S4, S5,S7, and S11 spectras respectively reflect gamma-aminobutyric acid (GABA), glutamic acid (Glu), 5-hydroxytryptamine (5-HT), acetylcholine (ACh), norepinephrine, and dopamine. MAIN OUTCOME MEASURES: Neurotransmitter changes in the brains of all subjects, and correlations between dopamine concentrations and UPDRS assessment. Neurotransmitter changes in a subgroup of patients prior to and 1.5 hours after medicating with Benserazide. RESULTS: Concentrations of 5-HT, ACh, and norepinephrine were decreased in the PD group, and GABA was increased. However, there was no significant difference compared with the normal control group (P > 0.05). The level of dopamine in PD group was

  9. Insulin resistance and occurrence and prognosis of ischemic stroke A non-randomized concurrent control and intra-group comparison

    Institute of Scientific and Technical Information of China (English)

    Xiaohong Zhao; Shaojun Jiang; Yue Tan

    2008-01-01

    BACKGROUND: Clinical evidence has demonstrated that insulin resistance might be an independent risk factor for ischemic stroke, which has not been recognized. At present, insulin resistance has been proven to be an independent risk factor for coronary arteriosclerotic heart disease. However, the relationship between the onset and prognosis of ischemic stroke remains unclear. OBJECTIVE: This study was designed to analyze the relationship between insulin resistance and ischemic stroke and the correlation between insulin resistance and stroke risk factor, and to investigate the relationship between insulin resistance and ischemic stroke prognosis as well as whether insulin resistance is an independent prognostic factor. DESIGN: A non-randomized concurrent control experiment. SETTING: Department of Geriatric Disease, Second Affiliated Hospital of Kunming Medical College. PARTICIPANTS: A total of 106 inpatients with ischemic stroke of the cervical internal carotid artery, who had suffered from the disease within the previous 72 hours, were admitted to the Department of Neurology, First Affiliated Hospital of Kunming Medical College from March to December in 2005 and, recruited for the present study. All 106 inpatients corresponded to the diagnostic criteria of ischemic stroke, formulated at the Fourth National Cerebrovascular Disease Conference in 1995, and were confirmed as having had an ischemic stroke by CT/MRI examinations. The patient group consisted of 54 males and 52 females. An additional 50 healthy individuals, who received health examinations simultaneously, were included as controls. Among the control subjects, there were 26 males and 24 females. Informed consent for laboratory measurements was obtained from all subjects; this study was approved by the Hospital Ethics Committee.METHODS: Following admission, all subjects were inquired of age, gender, previous history, blood pressure, body temperature, admission time, and smoking habits. Meanwhile, they were

  10. Effects of different frequencies (2-3 days/week) of aquatic therapy program in adults with chronic low back pain. A non-randomized comparison trial.

    Science.gov (United States)

    Baena-Beato, Pedro Angel; Arroyo-Morales, Manuel; Delgado-Fernández, Manuel; Gatto-Cardia, Maria Claudia; Artero, Enrique G

    2013-01-01

    To study the effects of an aquatic therapy program with different frequencies (2 vs 3 days per week) in chronic low back pain. [corrected] Non-randomized comparison trial. Sport and spa community health club. Fifty-four adults with chronic low back pain (48.9 ± 10.0 years). Eight-week aquatic therapy program. Pain (visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (Short-Form Health Survey 36), body composition (weight, body mass index, body fat mass, body fat percentage, and skeletal muscle mass), and health-related fitness (sit and reach, handgrip strength, curl-up, Rockport 1-mile test). Both experimental groups presented significant improvements in low back pain and disability (P aquatic therapy program decrease levels of back pain and disability, increase quality of life, and improve health-related fitness in adults with chronic low back pain without effects in body composition. A dose-response effect was observed in some parameters, with greater benefits when exercising 3 days per week compared with 2 days. Wiley Periodicals, Inc.

  11. Does balneotherapy with low radon concentration in water influence the endocrine system? A controlled non-randomized pilot study.

    Science.gov (United States)

    Nagy, Katalin; Berhés, István; Kovács, Tibor; Kávási, Norbert; Somlai, János; Bender, Tamás

    2009-08-01

    Radon bath is a well-established modality of balneotherapy for the management of degenerative musculoskeletal disorders. The present study was conducted to ascertain whether baths of relatively low (80 Bq/l) radon concentration have any influence on the functioning of the endocrine system. In the study, a non-randomized pilot study, 27 patients with degenerative musculoskeletal disorders received 30-min radon baths (of 31-32 degrees C temperature and 80 Bq/l average radon concentration) daily, for 15 days. Twenty-five patients with matching pathologies were subjected to balneotherapy according to the same protocol, using thermal water with negligible radon content (6 Bq/l). Serum thyroid stimulating hormone, prolactin, cortisol, adrenocorticotropic hormone, and dehydroepiandrosterone levels were measured before and after a balneotherapy course of 15 sessions. Comparison of the accumulated data using the Wilcoxon test did not reveal any significant difference between pre- and post-treatment values or between the two patient groups. It is noted that while the beneficial effects of balneotherapy with radon-containing water on degenerative disorders is widely known, only few data have been published in the literature on its effect on endocrine functions. The present study failed to demonstrate any substantial effect of thermal water with relatively low radon content on the functioning of the endocrine system.

  12. Manometric Biofeedback Effectiveness on Urinary Incontinence and Quality of Life: A Non-Randomized Control Trial

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    Marcos E Fernandez-Cuadros

    2017-04-01

    Full Text Available Objectives This study aimed at examining if a 6-session protocol of tonic-phasic exercises using manometric biofeedback (BFB is capable of improving quality of life (QoL and muscular strength in patients with urinary incontinence (UI. Methods A prospective quasi-experimental before-after study was performed on 31 patients with Urinary Incontinence (UI referred to the rehabilitation department of Santa Cristina’s University hospital, Madrid, Spain. The study was performed from January to December 2016. At initial evaluation, affiliation of data, predisposing factors, and type of UI were recorded. Patients were given lifestyle recommendations and international consultation on incontinence questionnaire short form (ICIQ-SF/ incontinence quality-of-life measure (I-QOL questionnaires/scales to be fulfilled at the beginning/end of treatment. Manometric evaluation was recorded at initial/final evaluation by MYOMED ® 932. Manometric-BFB protocol consisted of a 30-minute session of tonic/phasic exercises (15 minutes each, 2 times a week for up to 6 sessions, supervised by a physiotherapist. Results Mean age was 52 ± 12.1 years. Overall, 96.7% (n = 31 of the participants were females. Maximum and mean strength of pelvic floor contraction was 24 ± 17.72 and 4.9 ± 4.1 mmHg, and increased significantly after treatment to 35 ± 20.85 and 7.45 ± 4.92 mmHg (P < 0.01. The mean ICIQ-SF score was 9.13 ± 5.18 and decreased significantly to 6.13 ± 4.75 (P = 0.003. The mean I-QoL score increased significantly from 70.33 ± 22.12 to 81.25 ± 16.72 (P = 0.0017. The I-QoL Limiting Behaviour (LB-subscale raised from 68.38 ± 23.33 to 80 ± 16.56 (P = 0.0015; I-QoL Psychosocial Impact (PI-subscale increased from 77.43 ± 24.51 to 80 ± 17.47 (p = 0.0152; and I-QoL social embarrassment (SE-subscale incremented from 60.72 ± 22.37 to 74.37 ± 20.86 (P = 0.0007. Conclusions Manometric-BFB protocol is capable of decreasing UI and to improve QoL and manometric values. This reduced protocol could be applied to other public and private institutions and it could have an economical impact on the health system and on patients’ economy.

  13. Non-randomized therapy trial to determine the safety and efficacy of heavy ion radiotherapy in patients with non-resectable osteosarcoma

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    Bischof Marc

    2010-03-01

    Full Text Available Abstract Background Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. For effective treatment, local control of the tumor is absolutely critical, because the chances of long term survival are EURAMOS1. Local photon radiotherapy has previously been used in small series and in an uncontrolled, highly individualized fashion, which, however, documented that high dose radiotherapy can, in principle, be used to achieve local control. Generally the radiation dose that is necessary for a curative approach can hardly be achieved with conventional photon radiotherapy in patients with non-resectable tumors that are usually located near radiosensitive critical organs such as the brain, the spine or the pelvis. In these cases particle Radiotherapy (proton therapy (PT/heavy ion therapy (HIT may offer a promising new alternative. Moreover, compared with photons, heavy ion beams provide a higher physical selectivity because of their finite depth coverage in tissue. They achieve a higher relative biological effectiveness. Phase I/II dose escalation studies of HIT in adults with non-resectable bone and soft tissue sarcomas have already shown favorable results. Methods/Design This is a monocenter, single-arm study for patients ≥ 6 years of age with non-resectable osteosarcoma. Desired target dose is 60-66 Cobalt Gray Equivalent (Gy E with 45 Gy PT (proton therapy and a carbon ion boost of 15-21 GyE. Weekly fractionation of 5-6 × 3 Gy E is used. PT/HIT will be administered exclusively at the Ion Radiotherapy Center in Heidelberg. Furthermore, FDG-PET imaging characteristics of non-resectable osteosarcoma before and after PT/HIT will be investigated prospectively. Systemic disease before and after PT/HIT is targeted by standard chemotherapy protocols and is not part of this trial. Discussion The primary objectives of this trial are the determination of feasibility and toxicity of HIT. Secondary objectives are tumor response

  14. A prospective, non-randomized phase II trial of Trastuzumab and Capecitabine in patients with HER2 expressing metastasized pancreatic cancer

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    Endlicher Esther

    2009-01-01

    Full Text Available Abstract Background Pancreatic cancer is the fourth most common cause of cancer related death in Western countries. Advantages in surgical techniques, radiation and chemotherapy had almost no impact on the long term survival of affected patients. Therefore, the need for better treatment strategies is urgent. HER2, a receptor tyrosine kinase of the EGFR family, involved in signal transduction pathways leading to cell growth and differentiation is overexpressed in a number of cancers, including breast and pancreatic cancer. While in breast cancer HER2 has already been successfully used as a treatment target, there are only limited data evaluating the effects of inhibiting HER2 tyrosine kinases in patients with pancreatic cancer. Methods Here we report the design of a prospective, non-randomized multi-centered Phase II clinical study evaluating the effects of the Fluoropyrimidine-carbamate Capecitabine (Xeloda ® and the monoclonal anti-HER2 antibody Trastuzumab (Herceptin® in patients with non-resectable, HER2 overexpressing pancreatic cancer. Patients eligible for the study will receive Trastuzumab infusions on day 1, 8 and 15 concomitant to the oral intake of Capecitabine from day 1 to day 14 of each three week cylce. Cycles will be repeated until tumor progression. A total of 37 patients will be enrolled with an interim analysis after 23 patients. Discussion Primary end point of the study is to determine the progression free survival after 12 weeks of bimodal treatment with the chemotherapeutic agent Capecitabine and the anti-HER2 antibody Trastuzumab. Secondary end points include patient's survival, toxicity analysis, quality of life, the correlation of HER2 overexpression and clinical response to Trastuzumab treatment and, finally, the correlation of CA19-9 plasma levels and progression free intervals.

  15. A non-randomized confirmatory trial of segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-section computed tomography (JCOG1211).

    Science.gov (United States)

    Aokage, Keiju; Saji, Hisashi; Suzuki, Kenji; Mizutani, Tomonori; Katayama, Hiroshi; Shibata, Taro; Watanabe, Syunichi; Asamura, Hisao

    2017-05-01

    Lobectomy has been the standard surgery for even stage I lung cancer since the validity of limited resection for stage I lung cancer was denied by the randomized study reported in 1995. The aim of this non-randomized confirmatory going on since September 2013 is to confirm the efficacy of a segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-slice computed tomography. A total of 390 patients from 42 Japanese institutions are recruited within 4 years. The primary endpoint of this study is a 5-year relapse-free survival in all of the patients who undergo a segmentectomy for a lung nodule. The secondary endpoints are overall survival, annual relapse-free survival, disease-free survival, proportion of local relapse, postoperative pulmonary function, proportion of segmentectomy completion, proportion of R0 resection completion by segmentectomy, adverse events, and serious adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000011819 ( http://www.umin.ac.jp/ctr/ ). Patient's accrual has been already finished in November, 2015 and the primary analysis will be performed in 2021. This study is one of the pivotal trial of lung segmentectomy for early lung cancer. The result will provide a clear evidence for our daily clinics and will be possible contribution to preserving pulmonary function for lung cancer patients.

  16. Mobilisation of hematopoietic CD34+ precursor cells in patients with acute stroke is safe--results of an open-labeled non randomized phase I/II trial.

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    Sandra Boy

    Full Text Available BACKGROUND: Regenerative strategies in the treatment of acute stroke may have great potential. Hematopoietic growth factors mobilize hematopoietic stem cells and may convey neuroprotective effects. We examined the safety, potential functional and structural changes, and CD34(+ cell-mobilization characteristics of G-CSF treatment in patients with acute ischemic stroke. METHODS AND RESULTS: Three cohorts of patients (8, 6, and 6 patients per cohort were treated subcutaneously with 2.5, 5, or 10 µg/kg body weight rhG-CSF for 5 consecutive days within 12 hrs of onset of acute stroke. Standard treatment included i.v. thrombolysis. Safety monitoring consisted of obtaining standardized clinical assessment scores, monitoring of CD34(+ stem cells, blood chemistry, serial neuroradiology, and neuropsychology. Voxel-guided morphometry (VGM enabled an assessment of changes in the patients' structural parenchyma. 20 patients (mean age 55 yrs were enrolled in this study, 5 of whom received routine thrombolytic therapy with r-tPA. G-CSF treatment was discontinued in 4 patients because of unrelated adverse events. Mobilization of CD34(+ cells was observed with no concomitant changes in blood chemistry, except for an increase in the leukocyte count up to 75,500/µl. Neuroradiological and neuropsychological follow-up studies did not disclose any specific G-CSF toxicity. VGM findings indicated substantial atrophy of related hemispheres, a substantial increase in the CSF space, and a localized increase in parenchyma within the ischemic area in 2 patients. CONCLUSIONS: We demonstrate a good safety profile for daily administration of G-CSF when begun within 12 hours after onset of ischemic stroke and, in part in combination with routine i.v. thrombolysis. Additional analyses using VGM and a battery of neuropsychological tests indicated a positive functional and potentially structural effect of G-CSF treatment in some of our patients. TRIAL REGISTRATION: German

  17. Change in organizational justice as a predictor of insomnia symptoms: longitudinal study analysing observational data as a non-randomized pseudo-trial.

    Science.gov (United States)

    Lallukka, Tea; Halonen, Jaana I; Sivertsen, Børge; Pentti, Jaana; Stenholm, Sari; Virtanen, Marianna; Salo, Paula; Oksanen, Tuula; Elovainio, Marko; Vahtera, Jussi; Kivimäki, Mika

    2017-01-08

    Despite injustice at the workplace being a potential source of sleep problems, longitudinal evidence remains scarce. We examined whether changes in perceived organizational justice predicted changes in insomnia symptoms. Data on 24 287 Finnish public sector employees (82% women), from three consecutive survey waves between 2000 and 2012, were treated as 'pseudo-trials'. Thus, the analysis of unfavourable changes in organizational justice included participants without insomnia symptoms in Waves 1 and 2, with high organizational justice in Wave 1 and high or low justice in Wave 2 (N = 6307). In the analyses of favourable changes in justice, participants had insomnia symptoms in Waves 1 and 2, low justice in Wave 1 and high or low justice in Wave 2 (N = 2903). In both analyses, the outcome was insomnia symptoms in Wave 3. We used generalized estimating equation models to analyse the data. After adjusting for social and health-related covariates in Wave 1, unfavourable changes in relational organizational justice (i.e. fairness of managerial behaviours) were associated with increased odds of developing insomnia symptoms [odds ratio = 1.15; 95% confidence interval (CI) 1.02-1.30]. A favourable change in relational organizational justice was associated with lower odds of persistent insomnia symptoms (odds ratio = 0.83; 95% CI 0.71-0.96). Changes in procedural justice (i.e. the fairness of decision-making procedures) were not associated with insomnia symptoms. These data suggest that changes in perceived relational justice may affect employees' sleep quality. Decreases in the fairness of managerial behaviours were linked to increases in insomnia symptoms, whereas rises in fairness were associated with reduced insomnia symptoms. © The Author 2017. Published by Oxford University Press on behalf of the International Epidemiological Association.

  18. Effect of community-based education to Korean mothers in relation to the prevention of cervical cancer in their daughters: A non-randomized trial.

    Science.gov (United States)

    Kim, Hae Won; Park, Seungmi; Kim, Youngji

    2017-07-13

    This study was conducted in order to examine the effects of community-based education on cervical cancer prevention in relation to South Korean mothers' knowledge about the Papanicolau (Pap) test and human papillomavirus, self-confidence in communication with their daughters, and health-related beliefs about their daughters. A quasi-experimental pre-post design was used. For the experimental group, face-to-face education was administered to 35 participants for 60 min. For the control group, 35 participants were taught by using standardized materials for 20 min. The experimental group showed a significant increase in Pap test knowledge, cervical cancer knowledge, and self-confidence in communication with their daughters, compared to the control group. In the post-test, the mothers in the experimental group also perceived cervical cancer as more threatening, their daughter as more susceptible to cervical cancer, Pap tests as being recommended for their daughters, and they showed a significant increase in their self-efficacy of recommending the Pap test to their daughter. Community-based education for mothers is effective in increasing their human papillomavirus knowledge, Pap test knowledge, improving their confidence in communication with their daughters, and in some of the health-related beliefs regarding their daughters. © 2017 Japan Academy of Nursing Science.

  19. Issues Relating to Confounding and Meta-analysis When Including Non-Randomized Studies in Systematic Reviews on the Effects of Interventions

    Science.gov (United States)

    Valentine, Jeffrey C.; Thompson, Simon G.

    2013-01-01

    Background: Confounding caused by selection bias is often a key difference between non-randomized studies (NRS) and randomized controlled trials (RCTs) of interventions. Key methodological issues: In this third paper of the series, we consider issues relating to the inclusion of NRS in systematic reviews on the effects of interventions. We discuss…

  20. Estudos dos padrões de não aleatoriedade dos gráficos de controle de Shewhart: um enfoque probabilístico Studies on non-random patterns in Shewhart control charts

    Directory of Open Access Journals (Sweden)

    Quintiliano Siqueira Schroden Nomelini

    2009-09-01

    Full Text Available Além de investimento em novas tecnologias e modernização do parque industrial, a competitividade dos produtos brasileiros está ligada ao aumento de produtividade. O Controle Estatístico de Processo (CEP, junto com os gráficos de controle, inseriu-se neste contexto no que diz respeito ao controle das características significativas do produto e do processo, em tempo real, garantindo níveis de qualidade, a um custo exigido pelo mercado. Um procedimento importante é a interpretação dos gráficos de controle. Um estudo foi feito para ilustrar e discutir padrões de não aleatoriedade, que auxiliam na interpretação de tais gráficos. Alguns padrões de não aleatoriedade foram ilustrados e, por meio de cálculo de probabilidade, mostrou-se quais deles rejeitaram a hipótese de controle estatístico, a um nível de significância pré-especificado. Concluiu-se que os padrões mencionados na literatura não eram tão informativos. No que diz respeito ao nível de significância, observou-se então que em alguns padrões a um certo nível de significância retornaram resultados diferentes dos mencionados na literatura.In the last two decades, the Brazilian consuming market was modified by the insertion of products of better quality and minor cost. Statistical Process Control (SPC and control charts look after significant characteristics products and processes, in real time, guaranteeing quality levels, in a cost demanded by the market. In that context, an important procedure is the interpretation of the control charts; this is made through non-random patters. A study was made illustrating and arguing such standards. Standards had been illustrated and one revealed which of them, rejected the nullity hypothesis, under a determined significance. One concluded that the standards mentioned in literature are not so informative and can be improved.

  1. Psychological treatment of late-life depression:a meta-analysis of randomized controlled trials

    OpenAIRE

    2006-01-01

    SUMMARY Background Older meta-analyses of the effects of psychological treatments for depression in older adults have found that these treatments have large effects. However, these earlier meta-analyses also included non-randomized studies, and did not include newer high-quality randomized controlled trials. Methods We conducted a meta-analysis of randomized studies on psychological treatments for depression in older adults. Results Twenty-five studies were included, of which 17 compared a ps...

  2. Birth Control in Clinical Trials

    Science.gov (United States)

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  3. Meta-analyses including non-randomized studies of therapeutic interventions: a methodological review

    Directory of Open Access Journals (Sweden)

    Timor Faber

    2016-03-01

    Full Text Available Abstract Background There is an increasing number of meta-analyses including data from non-randomized studies for therapeutic evaluation. We aimed to systematically assess the methods used in meta-analyses including non-randomized studies evaluating therapeutic interventions. Methods For this methodological review, we searched MEDLINE via PubMed, from January 1, 2013 to December 31, 2013 for meta-analyses including at least one non-randomized study evaluating therapeutic interventions. Etiological assessments and meta-analyses with no comparison group were excluded. Two reviewers independently assessed the general characteristics and key methodological components of the systematic review process and meta-analysis methods. Results One hundred eighty eight meta-analyses were selected: 119 included both randomized controlled trials (RCTs and non-randomized studies of interventions (NRSI and 69 only NRSI. Half of the meta-analyses (n = 92, 49 % evaluated non-pharmacological interventions. “Grey literature” was searched for 72 meta-analyses (38 %. An assessment of methodological quality or risk of bias was reported in 135 meta-analyses (72 % but this assessment considered the risk of confounding bias in only 33 meta-analyses (18 %. In 130 meta-analyses (69 %, the design of each NRSI was not clearly specified. In 131 (70 %, whether crude or adjusted estimates of treatment effect for NRSI were combined was unclear or not reported. Heterogeneity across studies was assessed in 182 meta-analyses (97 % and further explored in 157 (84 %. Reporting bias was assessed in 127 (68 %. Conclusions Some key methodological components of the systematic review process—search for grey literature, description of the type of NRSI included, assessment of risk of confounding bias and reporting of whether crude or adjusted estimates were combined—are not adequately carried out or reported in meta-analyses including NRSI.

  4. Heat rate variability and dyssomnia and their correlations to neurological defects in cerebral infarction patients complicated by insomnia A concurrent non-randomized case-control study

    Institute of Scientific and Technical Information of China (English)

    Jianping Chu; Xueli Shen; Jun Fan; Changhai Chen; Shuyang Lin

    2008-01-01

    BACKGROUND: Heart rate variability refers to the beat-to-beat alteration in heart rate. It is usually a slight periodic variation of R-R intervals. Much information of autonomic nerve system balance can be obtained by measuring the heart rate variability of patients. It remains to be shown whether heart rate variability can be used as an index for determining the severity of insomnia and cerebral infarction. OBJECTIVE: This study aimed to analyze the correlation for each frequency spectrum parameter of heart rate variability with an insomnia index, as well as the degree of neurological defects in patients with simple cerebral infarction and cerebral infarction complicated by insomnia. The goal was to verify the feasibility of frequency spectrum parameters for heart rate variability as a marker for insomnia and cerebral infarction. DESIGN: A case-control observation. SETTING: Department of Neurology, First Hospital Affiliated to China Medical University. PARTICIPANTS: Sixty inpatients, and/or outpatients, with cerebral infarction were admitted to the 202 Hospital of Chinese PLA between December 2005 and October 2006, confirmed by CT, and recruited to the study. According to the insomnia condition (insomnia is defined by a Pittsburgh Sleep Quality Index score > 7), the patients were assigned to a simple cerebral infarction group and a cerebral infarction complicated by insomnia group, with 30 subjects in each group. Thirty additional subjects, who concurrently received ex-aminations and were confirmed to not suffer from cerebral infarction and insomnia, were recruited into the control group. Written informed consent was obtained from each subject for laboratory specimens. The pro-tocol was approved by the Hospital's Ethics Committee. METHODS: Following admission, each subject's neurological impairment was assessed with the National Institutes of Health Stroke Scale and Pittsburgh Sleep Quality Index. Heart rate variability of each subject was measured with an

  5. Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study.

    Directory of Open Access Journals (Sweden)

    Nina Rydland Olsen

    Full Text Available Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs, are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students.We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1 The Adapted Fresno test (AFT, 2 the EBP Belief Scale and 3 the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations.In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1, p < 0.001 and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2, p = 0.002, but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1, p = 0.574. Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only.A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs' abilities to apply EBP knowledge and skills when supervising students.

  6. Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study

    Science.gov (United States)

    Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

    2015-01-01

    Background and Purpose Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. Methods We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. Results In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p<0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. Conclusions A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs’ abilities to apply EBP knowledge and skills when supervising students. PMID:25894559

  7. Responses of serum inflammatory factor high-sensitivity C-reactive protein, interleukin-6, and tumor necrosis factor-alpha in elderly males with cerebral infarction Non-randomized concurrent control

    Institute of Scientific and Technical Information of China (English)

    Guiping Jiao; Xinjie Tan; Zhiliu Yuan; Chunling Li; Jing Wang; Wen Mo

    2008-01-01

    BACKGROUND: Cerebral infarction is poorly treated due to neuronal necrosis and secondary pathophysiological changes; for example, free radical production and inflammatory reactions.OBJECTIVE: To detect the levels of high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), and tumor nccrosis factor-α (TNF-α) in elderly males with cerebral infarction.DESIGN: Non-randomized current control study.SETTING: Cadre Medical Department, Guizhou Provincial People's Hospital.PARTICIPANTS: Forty elderly males (65-89 years old) with cerebral infarction were selected from Cadre Medical Department, Guizhou Provincial People's Hospital from February 2004 to December 2006. All patients met the diagnostic criteria of cerebral infarction modified at the 4th National Cerebrovascular Disease Academic Meeting, and were diagnosed on the basis of CT or MRI tests. Furthermore, 35 elderly male inpatients (65-87 years old) without cerebral infarction were selected as the control group. Included subjects provided confirmed consent and did not have heart disease, diabetes mellitus, lipid disorder, acute trauma, infection, rheumatism, or other inflammatory diseases. The study was approved by the local ethics committee. There were no significant differences in age, blood pressure, and lipid levels between the cerebral infarction group and the control group (P>0.05), and this suggested that the baseline data of both groups were comparable.METHODS: Fasting venous blood was drawn from cerebral infarction patients 24 hours after cerebral infarction attack and from control subjects 24 hours after hospitalization. A latex-enhanced immunoturbidimetric assay and an enzyme-linked immunosorbent assay were used to detect the levels of hs-CRP, IL-6, and TNF-α in the serum.MAIN OUTCOME MEASURES: The levels of hs-CRP, IL-6, and TNF-α in the serum in both groups.RESULTS: Forty cerebral infarction patients and thirty-five control subjects were included in the final analysis without any loss

  8. Effectiveness and efficiency of primary care based case management for chronic diseases: rationale and design of a systematic review and meta-analysis of randomized and non-randomized trials [CRD32009100316].

    NARCIS (Netherlands)

    Freund, T.; Kayling, F.; Miksch, A.; Szecsenyi, J.; Wensing, M.J.P.

    2010-01-01

    BACKGROUND: Case management is an important component of structured and evidence-based primary care for chronically ill patients. Its effectiveness and efficiency has been evaluated in numerous clinical trials. This protocol describes aims and methods of a systematic review of research on the

  9. Supported employment: randomised controlled trial*

    Science.gov (United States)

    Howard, Louise M.; Heslin, Margaret; Leese, Morven; McCrone, Paul; Rice, Christopher; Jarrett, Manuela; Spokes, Terry; Huxley, Peter; Thornicroft, Graham

    2010-01-01

    Background There is evidence from North American trials that supported employment using the individual placement and support (IPS) model is effective in helping individuals with severe mental illness gain competitive employment. There have been few trials in other parts of the world. Aims To investigate the effectiveness and cost-effectiveness of IPS in the UK. Method Individuals with severe mental illness in South London were randomised to IPS or local traditional vocational services (treatment as usual) (ISRCTN96677673). Results Two hundred and nineteen participants were randomised, and 90% assessed 1 year later. There were no significant differences between the treatment as usual and intervention groups in obtaining competitive employment (13% in the intervention group and 7% in controls; risk ratio 1.35, 95% CI 0.95–1.93, P = 0.15), nor in secondary outcomes. Conclusions There was no evidence that IPS was of significant benefit in achieving competitive employment for individuals in South London at 1-year follow-up, which may reflect suboptimal implementation. Implementation of IPS can be challenging in the UK context where IPS is not structurally integrated with mental health services, and economic disincentives may lead to lower levels of motivation in individuals with severe mental illness and psychiatric professionals. PMID:20435968

  10. The Influence of Plantar Short Foot Muscle Exercises on Foot Posture and Fundamental Movement Patterns in Long-Distance Runners, a Non-Randomized, Non-Blinded Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Iwona Sulowska

    Full Text Available The objective of this study was to evaluate the influence of two kinds of plantar short foot muscles exercise on foot posture and fundamental movement patterns in long-distance runners.A parallel group non-blinded trial with 6-week follow-up.Twenty five long-distance runners aged 22-35 years. They were divided into two groups. In group 1 (n = 13 subjects performed the exercise "Vele's Forward Lean" and "Reverse Tandem Gait" and in Group 2 (n = 12 the "Short Foot Exercise." The runners performed the exercises daily for 6 weeks. The Foot Posture Index (FPI-6 and The Functional Movement Screen (FMS tests were performed twice: at baseline and after 6 weeks of the exercise.A significant improvement was observed in FPI -6 (talar head palpation in Group 1, and inversion/eversion of the calcaneus in Group 2. Also in Group 1 a significant improvement was noted in FMS tests: deep squat, active straight leg raise and in total score.Short foot muscles strengthening exercises have beneficial effect on functional movement patterns and on foot posture, therefore they should be included as a part of daily training program of runners.Australian New Zealand Clinical Trials Registry ACTRN12615001200572.

  11. Effective group training for patients with unexplained physical symptoms: A randomized controlled trial with a non-randomized one-year follow-up

    NARCIS (Netherlands)

    L.N.L. Zonneveld (Lyonne); Y.R. van Rood (Yanda); R. Timman (Reinier); C.G. Kooiman (Cornelis); A. van 't Spijker (Adriaan); J.J. van Busschbach (Jan)

    2012-01-01

    textabstractBackground: Although cognitive-behavioral therapy for Unexplained Physical Symptoms (UPS) is effective in secondary care, studies done in primary care produced implementation problems and conflicting results. We evaluated the effectiveness of a cognitive-behavioral group training tailore

  12. Single dosage of doxycycline for prophylaxis against leptospiral infection and leptospirosis during urban flooding in southern Thailand: a non-randomized controlled trial.

    Science.gov (United States)

    Chusri, Sarunyou; McNeil, Edward B; Hortiwakul, Thanaporn; Charernmak, Boonsri; Sritrairatchai, Somporn; Santimaleeworagun, Wichai; Pattharachayakul, Sutthiporn; Suksanan, Paritasana; Thaisomboonsuk, Butsaya; Jarman, Richard G

    2014-11-01

    This study was conducted to investigate the protective efficacy of a single dosage of 200 mg doxycycline against leptospiral infection and leptospirosis and associated risk factors among residents exposed to flooding in southern Thailand. Of 641 participants, 600 received doxycycline while 41 did not. Twenty two participants were infected with Leptospira and six developed leptospirosis. Having a laceration wound was significantly associated with leptospiral infection (odds ratio [OR] = 37.20; P doxycycline and five who did not, were infected with Leptospira, resulting a protective efficacy of 76.8% (95% confidence interval [CI] = 34.3%-92.0%). Four who received doxycycline and two who did not, developed leptospirosis, resulting a protective efficacy of 86.3% (CI = -9.8%-98.2%). Among the participants with laceration wound, the protective efficacy for leptospiral infection was 92.0% (CI = 81.2%-96.6%) and for leptospirosis was 95.6% (CI = 78.2%-99.3%). Among the participants exposed to flood water less than or equal to 3 h per day, the protective efficacy for leptospiral infection was 89.2% (95% CI 63.6%-96.67%). A single dosage of 200 mg doxycycline for prophylaxis might be effective for preventing leptospirosis among flood victims with laceration wound after recent flood exposure.

  13. Inbreeding avoidance through non-random mating in sticklebacks.

    Science.gov (United States)

    Frommen, Joachim G; Bakker, Theo C M

    2006-06-22

    Negative effects of inbreeding are well documented in a wide range of animal taxa. Hatching success and survival of inbred offspring is reduced in many species and inbred progeny are often less attractive to potential mates. Thus, individuals should avoid mating with close kin. However, experimental evidence for inbreeding avoidance through non-random mating in vertebrates is scarce. Here, we show that gravid female three-spined sticklebacks (Gasterosteus aculeatus) when given the choice between a courting familiar brother and a courting unfamiliar non-sib prefer to mate with the non-sib and thus avoid the disadvantages of incest. We controlled for differences in males' body size and red intensity of nuptial coloration. Thus, females adjust their courting behaviour to the risk of inbreeding.

  14. a randomized controlled clinical trial

    OpenAIRE

    2013-01-01

    In this study we aimed to evaluate the effectiveness of Iyengar yoga in chronic neck pain by means of a randomized clinical trial. 77 with chronic neck pain who scored > 40 mm on a 100-mm visual analog scale (VAS) were randomized to a nine week Iyengar yoga program with weekly 90-minute classes or to a self-care/exercise program. The primary outcome measure was change of mean pain at rest (VAS) from baseline to week ten. Secondary outcomes included pain at motion, functional disabilit...

  15. Razors versus clippers. A randomised controlled trial.

    Science.gov (United States)

    Taylor, Tracy; Tanner, Judith

    2005-12-01

    The purpose of this randomised controlled trial was to determine if patients showed a preference for preoperative hair removal with razors or clippers and to identify if one method was associated with more trauma or postoperative infections. The trial took place in a day surgery unit with patients who were having a range of surgical procedures including hernias and varicose veins. This study was sponsored by an award from the NATN/3M Clinical Fellowship.

  16. Control groups in recent septic shock trials

    DEFF Research Database (Denmark)

    Pettilä, Ville; Hjortrup, Peter Buhl; Jakob, Stephan M

    2016-01-01

    , and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. RESULTS: A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58......PURPOSE: The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. METHODS: We searched for original articles presenting...... randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics...

  17. Placebo-Controlled Trials, Ethics of

    NARCIS (Netherlands)

    van der Graaf, R; Rid, Annette

    2015-01-01

    There are often good scientific and ethical reasons for using placebo controls in clinical trials. At the same time placebo use is controversial, especially when an established effective treatment is being withheld from the control group. This article gives an overview of the key ethical positions

  18. Placebo-Controlled Trials, Ethics of

    NARCIS (Netherlands)

    van der Graaf, R; Rid, Annette

    2015-01-01

    There are often good scientific and ethical reasons for using placebo controls in clinical trials. At the same time placebo use is controversial, especially when an established effective treatment is being withheld from the control group. This article gives an overview of the key ethical positions i

  19. Effect of a multidisciplinary stress treatment programme on the return to work rate for persons with work-related stress. A non-randomized controlled study from a stress clinic

    Directory of Open Access Journals (Sweden)

    Bech Per

    2010-11-01

    Full Text Available Abstract Background In recent years an increasing number of patients have been referred to the medical sector with stress symptoms. Moreover, these conditions imply increased sickness absence. This indicates a need for treatment programmes in general medical practice. The aim of this study was to test the effect of a multidisciplinary stress treatment programme on the return to work (RTW rate in persons with work-related stress and establish predictive factors for this outcome. Methods During a two-year period 63 out of 73 referrals to the Stress Clinic (a section of a Clinic of Occupational Medicine completed a stress treatment programme consisted of the following: 1 Identification of relevant stressors. 2. Changing the coping strategies of the participants. 3. Evaluating/changes in participant workload and tasks. 4. Relaxation techniques. 5. Physical exercise. 6. Psychiatric evaluation when indicated by depression test score. On average each patient attended six one-hour sessions over the course of four months. A group of 34 employees referred to the Clinic of Occupational Medicine by their general practitioners served as a control group. Each participant had a one-hour consultation at baseline and after four months. A specialist in occupational medicine carried out all sessions. Return To Work (RTW, defined as having a job and not being on sick leave at the census, was used as outcome measure four months after baseline, and after one and two years. Results The level of sick leave in the stress treatment group dropped from 52% to 16% during the first four months of follow-up and remained stable. In the control group, the reduction in sick leave was significantly smaller, ranging from 48% at baseline to 27% after four months and 24% after one year. No statistically significant difference between the two groups was observed after one and two years. Age below 50 years and being a manager increased the odds ratio for RTW after one and two years

  20. Calculating the probability of random sampling for continuous variables in submitted or published randomised controlled trials.

    Science.gov (United States)

    Carlisle, J B; Dexter, F; Pandit, J J; Shafer, S L; Yentis, S M

    2015-07-01

    In a previous paper, one of the authors (JBC) used a chi-squared method to analyse the means (SD) of baseline variables, such as height or weight, from randomised controlled trials by Fujii et al., concluding that the probabilities that the reported distributions arose by chance were infinitesimally small. Subsequent testing of that chi-squared method, using simulation, suggested that the method was incorrect. This paper corrects the chi-squared method and tests its performance and the performance of Monte Carlo simulations and ANOVA to analyse the probability of random sampling. The corrected chi-squared method and ANOVA method became inaccurate when applied to means that were reported imprecisely. Monte Carlo simulations confirmed that baseline data from 158 randomised controlled trials by Fujii et al. were different to those from 329 trials published by other authors and that the distribution of Fujii et al.'s data were different to the expected distribution, both p non-random (i.e. unreliable) data in randomised controlled trials submitted to journals. © 2015 The Association of Anaesthetists of Great Britain and Ireland.

  1. Therapeutic effects of acupuncture for neurogenic dysphagia--a randomized controlled trial.

    Science.gov (United States)

    Chan, Sze-Ling; Or, Ka-Hang; Sun, Wai-Zhu; Ng, Kwan-Yee; Lo, See-Kit; Lee, Yuet-Sheung

    2012-03-01

    To evaluate the therapeutic effects and long-term efficacy of acupuncture for neurogenic dysphagia. Subjects with neurogenic dysphagia undergoing routine swallowing management were randomized to receive either 20 sessions of true acupuncture (experimental group) or sham acupuncture (control group 1) for approximately one and a half months. A third group (control group 2) comprised of non-randomized subjects with neurogenic dysphagia who received routine care were recruited from separate wards. The outcomes were assessed by the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS), as well as by the consistencies of ingested food and fluid. A total of 87 subjects (experimental group, n = 20; control group 1, n = 19; control group 2, n = 48) were recruited into the trial. The average RBHOMS score showed a greater improvement in the experimental group and in control group 1 than in control group 2. The average levels of food and fluid consistencies displayed greater improvement in the experimental group than in the two control groups. This study demonstrates that acupuncture may have therapeutic effects and long-term efficacy for neurogenic dysphagia. However, due to an insufficient sample size and the lack of follow-up for control group 2, multi-centre trials employing a larger sample size may be required to draw concrete conclusions.

  2. Randomized controlled trials - a matter of design.

    Science.gov (United States)

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

  3. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  4. Clobazam: uncontrolled and standard controlled clinical trials.

    Science.gov (United States)

    Ban, T A; Amin, M M

    1979-01-01

    1 In an uncontrolled clinical trial, carried out in 11 psychiatric patients with the clinical diagnoses of anxiety neurosis and depressive neurosis, clobazam, a new benzodiazepine preparation, in the dosage range 10-60 mg daily produced statistically significant improvement in the total and both factor scores of the Hamilton Anxiety Scale (HAM-A). The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 48 mg daily. 2 Results of the uncontrolled clinical trial were further substantiated in a standard-controlled clinical study in which no statistically significant difference between the therapeutic effectiveness of clobazam and diazepam could be revealed. The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 49 mg daily. There was a lower incidence of adverse effects reported in patients receiving clobazam than in those taking the control drug (diazepam).

  5. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  6. Effect of a multidisciplinary stress treatment programme on the return to work rate for persons with work-related stress. A non-randomized controlled study from a stress clinic

    DEFF Research Database (Denmark)

    Netterstrøm, Bo; Bech, Per

    2010-01-01

    Medicine) completed a stress treatment programme consisted of the following:1) Identification of relevant stressors. 2. Changing the coping strategies of the participants. 3. Evaluating/changes in participant workload and tasks. 4. Relaxation techniques. 5. Physical exercise. 6. Psychiatric evaluation when...... was to test the effect of a multidisciplinary stress treatment programme on the return to work (RTW) rate in persons with work-related stress and establish predictive factors for this outcome. METHODS: During a two-year period 63 out of 73 referrals to the Stress Clinic (a section of a Clinic of Occupational...... indicated by depression test score.On average each patient attended six one-hour sessions over the course of four months.A group of 34 employees referred to the Clinic of Occupational Medicine by their general practitioners served as a control group. Each participant had a one-hour consultation at baseline...

  7. The effectiveness of a multidisciplinary pain management programme managing chronic pain on pain perceptions, health-related quality of life and stages of change--A non-randomized controlled study.

    Science.gov (United States)

    Dysvik, Elin; Kvaløy, Jan Terje; Stokkeland, Ragnhild; Natvig, Gerd Karin

    2010-07-01

    Cognitive behavioural therapy (CBT) has been useful in the treatment of chronic pain conditions for many years. Given the increasing number of persons with chronic pain and associated psychosocial problems, the development and implementation of effective interventions based on CBT is warranted. The aim of this study is to evaluate the effects of a multidisciplinary pain management programme on health-related quality of life (HRQL), as measured by the Short Form Health Survey (SF-36), pain perception as measured by the Brief Pain Inventory (BPI), and readiness-to-change as measured by the Pain Stages of Change Questionnaire (PSOCQ). A pretest-post-test quasi-experimental design, with waiting list controls and baseline and post-test measures, was used. The study was conducted in the rehabilitation unit of a university hospital. Of 117 people suffering from chronic pain, 113 completed the 8-week multidisciplinary pain management programme. The patients were consecutive referrals. Inclusion criteria were: adults (18-67 years), pain lasting over 6 months, motivation and no ongoing litigation. Exclusion criteria were affected by major mental disorders or major medical conditions requiring treatment. The intervention was based on a cognitive behavioural approach. Therapeutic dialogues and training, combined with physical activity, were provided to a fixed plan, including homework. The programme has several features that directly address psychosocial aspects of chronic pain. Statistical and clinical significance are considered. The findings suggest that this programme has the potential to improve HRQL, reduce pain intensity and interference, and contribute to improvement in readiness-to-change. Statistically significant results are supplemented by results showing their clinical significance. Improvements in HRQL, pain-related disability, and readiness-to-change suggest that the vicious cycle of chronic pain may be alleviated by our programme. As we see it, effective

  8. Strategies for improving postpartum contraceptive use: evidence from non-randomized studies.

    Science.gov (United States)

    Lopez, Laureen M; Grey, Thomas W; Chen, Mario; Hiller, Janet E

    2014-11-27

    Nearly two-thirds of women in their first postpartum year have an unmet need for family planning. Adolescents often have repeat pregnancies within a year of giving birth. Women may receive counseling on family planning both antepartum and postpartum. Decisions about contraceptive use made right after counseling may differ considerably from actual postpartum use. In earlier work, we found limited evidence of effectiveness from randomized trials on postpartum contraceptive counseling. For educational interventions, non-randomized studies may be conducted more often than randomized trials. We reviewed non-randomized studies of educational strategies to improve postpartum contraceptive use. Our intent was to examine associations between specific interventions and postpartum contraceptive use or subsequent pregnancy. We searched for eligible non-randomized studies until 3 November 2014. Sources included CENTRAL, PubMed, POPLINE, and Web of Science. We also sought current trials via ClinicalTrials.gov and ICTRP. For additional citations, we examined reference lists of relevant reports and reviews. The studies had to be comparative, i.e., have intervention and comparison groups. The educational component could be counseling or another behavioral strategy to improve contraceptive use among postpartum women. The intervention had to include contact within six weeks postpartum. The comparison condition could be another behavioral strategy to improve contraceptive use, usual care, other health education, or no intervention. Our primary outcomes were postpartum contraceptive use and subsequent pregnancy. Two authors evaluated abstracts for eligibility and extracted data from included studies. We computed the Mantel-Haenszel odds ratio (OR) for dichotomous outcomes and the mean difference (MD) for continuous measures, both with 95% Confidence Intervals (CI). Where studies used adjusted analyses for continuous outcomes, we presented the results as reported by the investigators

  9. Diagnostic randomized controlled trials: the final frontier.

    Science.gov (United States)

    Rodger, Marc; Ramsay, Tim; Fergusson, Dean

    2012-08-16

    Clinicians, patients, governments, third-party payers, and the public take for granted that diagnostic tests are accurate, safe and effective. However, we may be seriously misled if we are relying on robust study design to ensure accurate, safe, and effective diagnostic tests. Properly conducted, randomized controlled trials are the gold standard for assessing the effectiveness and safety of interventions, yet are rarely conducted in the assessment of diagnostic tests. Instead, diagnostic cohort studies are commonly performed to assess the characteristics of a diagnostic test including sensitivity and specificity. While diagnostic cohort studies can inform us about the relative accuracy of an experimental diagnostic intervention compared to a reference standard, they do not inform us about whether the differences in accuracy are clinically important, or the degree of clinical importance (in other words, the impact on patient outcomes). In this commentary we provide the advantages of the diagnostic randomized controlled trial and suggest a greater awareness and uptake in their conduct. Doing so will better ensure that patients are offered diagnostic procedures that will make a clinical difference.

  10. Recent randomized controlled trials in otolaryngology.

    Science.gov (United States)

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  11. Increasing recruitment to randomised trials: a review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Torgerson David J

    2006-07-01

    Full Text Available Abstract Background Poor recruitment to randomised controlled trials (RCTs is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective. Methods We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors. Results We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive. Conclusion Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.

  12. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J

    2011-01-01

    BACKGROUND: Naproxen, ibuprofen and diclofenac are frequently used as comparators in randomized controlled trials (RCTs) on the safety and efficacy of cyclooxygenase (COX)-2 inhibitors. Different comparator doses may influence the results of RCTs. It has been hypothesized that RCTs of COX-2...... 1995 and 2009 in which celecoxib or rofecoxib were compared with naproxen, ibuprofen or diclofenac. All articles labelled as RCTs mentioning rofecoxib or celecoxib and one or more of the comparator drugs in the title and/or abstract were included. We extracted information on doses of both non...... dose trends in the case of rofecoxib. CONCLUSIONS: Although the dose trends over time differed for RCTs comparing rofecoxib and celecoxib with diclofenac, ibuprofen or naproxen, the results of our study do not support the hypothesis that dose trends influenced the decision to continue marketing...

  13. Enhancing adoptive parenting: a randomized controlled trial.

    Science.gov (United States)

    Rushton, Alan; Monck, Elizabeth; Leese, Morven; McCrone, Paul; Sharac, Jessica

    2010-10-01

    The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a "services as usual" group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference (p parenting" in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters' satisfaction with parenting in the intervention group compared to the routine service group.

  14. Non-random biodiversity loss underlies predictable increases in viral disease prevalence.

    Science.gov (United States)

    Lacroix, Christelle; Jolles, Anna; Seabloom, Eric W; Power, Alison G; Mitchell, Charles E; Borer, Elizabeth T

    2014-03-06

    Disease dilution (reduced disease prevalence with increasing biodiversity) has been described for many different pathogens. Although the mechanisms causing this phenomenon remain unclear, the disassembly of communities to predictable subsets of species, which can be caused by changing climate, land use or invasive species, underlies one important hypothesis. In this case, infection prevalence could reflect the competence of the remaining hosts. To test this hypothesis, we measured local host species abundance and prevalence of four generalist aphid-vectored pathogens (barley and cereal yellow dwarf viruses) in a ubiquitous annual grass host at 10 sites spanning 2000 km along the North American West Coast. In laboratory and field trials, we measured viral infection as well as aphid fecundity and feeding preference on several host species. Virus prevalence increased as local host richness declined. Community disassembly was non-random: ubiquitous hosts dominating species-poor assemblages were among the most competent for vector production and virus transmission. This suggests that non-random biodiversity loss led to increased virus prevalence. Because diversity loss is occurring globally in response to anthropogenic changes, such work can inform medical, agricultural and veterinary disease research by providing insights into the dynamics of pathogens nested within a complex web of environmental forces.

  15. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of ... Log in or Register to get access to full text downloads. ... Pharmacological control of pain is the mainstay of management of osteoarthritis.

  16. [Placebo control and clinical trial of Chinese medicine].

    Science.gov (United States)

    Wu, Jing

    2010-10-01

    World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM) and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.

  17. Pragmatic design in randomized controlled trials.

    Science.gov (United States)

    Purgato, M; Barbui, C; Stroup, S; Adams, C

    2015-01-01

    At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but 'local' and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials.

  18. Evidence for Non-Random Hydrophobicity Structures in Protein Chains

    CERN Document Server

    Irbäck, A; Potthast, F; Irb\\"ack, Anders; Peterson, Carsten; Potthast, Frank

    1996-01-01

    The question of whether proteins originate from random sequences of amino acids is addressed. A statistical analysis is performed in terms of blocked and random walk values formed by binary hydrophobic assignments of the amino acids along the protein chains. Theoretical expectations of these variables from random distributions of hydrophobicities are compared with those obtained from functional proteins. The results, which are based upon proteins in the SWISS-PROT data base, convincingly show that the amino acid sequences in proteins differ from what is expected from random sequences in a statistical significant way. By performing Fourier transforms on the random walks one obtains additional evidence for non-randomness of the distributions. We have also analyzed results from a synthetic model containing only two amino-acid types, hydrophobic and hydrophilic. With reasonable criteria on good folding properties in terms of thermodynamical and kinetic behavior, sequences that fold well are isolated. Performing t...

  19. Challenges of randomized controlled trial design in plastic surgery.

    Science.gov (United States)

    Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

    2011-01-01

    Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

  20. Analysis of scientific truth status in controlled rehabilitation trials.

    Science.gov (United States)

    Kerry, Roger; Madouasse, Aurélien; Arthur, Antony; Mumford, Stephen D

    2013-08-01

    Systematic reviews, meta-analyses and clinical guidelines (reviews) are intended to inform clinical practice, and in this sense can be thought of as scientific truthmakers. High-quality controlled trials should align to this truth, and method quality markers should predict truth status. We sought to determine in what way controlled trial quality relates to scientific truth, and to determine predictive utility of trial quality and bibliographic markers. A sample of reviews in rehabilitation medicine was examined. Two scientific truth dimensions were established based on review outcomes. Quality and bibliographic markers were extracted from associated trials for use in a regression analysis of their predictive utility for trial truth status. Probability analysis was undertaken to examine judgments of future trial truth status. Of the 93 trials included in contemporaneous reviews, overall, n = 45 (48%) were true. Randomization was found more in true trials than false trials in one truth dimension (P = 0.03). Intention-to-treat analysis was close to significant in one truth dimension (P = 0.058), being more commonly used in false trials. There were no other significant differences in quality or bibliographic variables between true and false trials. Regression analysis revealed no significant predictors of trial truth status. Probability analysis reported that the reasonable chance of future trials being true was between 2 and 5%, based on a uniform prior. The findings are at odds with what is considered gold-standard research methods, but in line with previous reports. Further work should focus on scientific dynamics within healthcare research and evidence-based practice constructs. © 2012 John Wiley & Sons Ltd.

  1. Design of a randomized controlled trial to compare debridement to observation of chondral lesions encountered during partial meniscectomy: The ChAMP (Chondral Lesions And Meniscus Procedures) Trial.

    Science.gov (United States)

    Bisson, Leslie J; Kluczynski, Melissa A; Wind, William M; Fineberg, Marc S; Bernas, Geoffrey A; Rauh, Michael A; Marzo, John M; Smolinski, Robert J

    2015-11-01

    Few studies have examined whether chondral lesions encountered in patients undergoing meniscectomy should be surgically treated. The primary aim of the ChAMP (Chondral Lesions And Meniscus Procedures) Trial is to determine whether there is a difference in knee pain between patients undergoing debridement versus observation of chondral lesions encountered during arthroscopic meniscectomy. This paper describes the rationale and study design for the ChAMP Trial. The ChAMP Trial is a randomized controlled trial of patients aged 30 and older undergoing partial meniscectomy and randomly allocated to debridement (CL-Deb, N=98) or observation (CL-Obs, N=92) of chondral lesions identified during surgery and deemed to be significant (Outerbridge Grade II-IV). Patients and data collectors were unaware of treatment allocation until completion of the study. Patients with surgically insignificant (Outerbridge Grade I) chondral lesions or no chondral lesions were included as a third non-randomized comparison group (NoCL, N=76). The primary outcome is the difference in knee pain assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index) between the CL-Deb and CL-Obs groups at 1-year after surgery. Secondary outcomes include 1-year differences in additional measures of knee pain, function, symptoms, activity, and quality of life assessed by the WOMAC, KOOS (Knee Injury and Osteoarthritis Outcome Score), visual analog pain scale, and physical exam; as well as general health assessed with the SF-36 (Short-form Health Survey). Increased intraoperative costs associated with the addition of chondral debridement will also be assessed. This study will add to the scant literature regarding management of chondral lesions in patients undergoing meniscectomy and might provide treatment guidance for clinicians and their patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  3. Design and Validity of Randomized Controlled Dental Restorative Trials

    Directory of Open Access Journals (Sweden)

    Gerd Göstemeyer

    2016-05-01

    Full Text Available Background: The evidence stemming from trials on restorative materials is shaped not only by trial findings, but also trial design and validity. We aimed to evaluate both aspects in randomized controlled dental restorative trials published from 2005–2015. Methods: Using systematic review methodology, we retrieved trials comparing restorative or adhesive dental materials. Two authors independently assessed design, risk of bias, registration status, and findings of trials. Descriptive and regression analyses were performed. Results: 114 studies on 15,321 restorations placed mainly in permanent teeth of 5232 patients were included. Per trial, the median number of patients was 37 (25th/75th percentiles: 30/51. Follow-up was 24 (20/48 months. Seventeen percent of trials reported on sample size calculations, 2% had been registered. Most trials (90% used US Public Health Service (USPHS criteria, and had a high risk of bias. More recent trials were more likely to have been registered, to have reported on sample size calculations, to be of low risk of bias, and to use other than USPHS-criteria. Twenty-three percent of trials yielded significant differences between groups. The likelihood of such differences was significantly increased in older studies, studies with potential reporting bias, published in journals with high impact factor (>2, longer follow-up periods, and not using USPHS-criteria. Conclusions: The majority of dental restorative trials published from 2005–2015 had limited validity. Risk of bias decreased in more recent trials. Future trials should aim for high validity, be registered, and use defined and appropriate sample sizes, follow-up periods, and outcome measures.

  4. 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.

  5. Effect of diclofenac suppository on pain control during flexible cystoscopy-A randomized controlled trial

    National Research Council Canada - National Science Library

    Nadeem, Mehwash; Ather, M Hammad

    2016-01-01

    TRIAL DESIGN: To compare the difference in pain score during flexible cystoscopy between patients undergoing the procedure with plain lubricating gel only and plain gel with diclofenac suppository in a randomized control trial. METHODS...

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

    National Research Council Canada - National Science Library

    Senn, Charlene Y; Eliasziw, Misha; Barata, Paula C; Thurston, Wilfreda E; Newby-Clark, Ian R; Radtke, H Lorraine; Hobden, Karen L

    2013-01-01

    .... 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...

  7. Hallucination focused integrative treatment : A randomized controlled trial

    NARCIS (Netherlands)

    Jenner, JA; Nienhuis, FJ; Wiersma, D; van de Willige, G

    2004-01-01

    Improvements in psychopathology, subjective burden, and coping with voices after hallucination focused integrative treatment (HIT) were studied in chronic schizophrenic patients with persistent (> 10 years), drug-refractory auditory hallucinations. In a randomized controlled trial, routine care was

  8. The ethics of placebo-controlled trials: methodological justifications.

    Science.gov (United States)

    Millum, Joseph; Grady, Christine

    2013-11-01

    The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling.

  9. Feasibility of a controlled trial aiming to prevent excessive pregnancy-related weight gain in primary health care

    Directory of Open Access Journals (Sweden)

    Weiderpass Elisabete

    2008-08-01

    Full Text Available Abstract Background Excessive gestational weight gain and postpartum weight retention may predispose women to long-term overweight and other health problems. Intervention studies aiming at preventing excessive pregnancy-related weight gain are needed. The feasibility of implementing such a study protocol in primary health care setting was evaluated in this pilot study. Methods A non-randomized controlled trial was conducted in three intervention and three control maternity and child health clinics in primary health care in Finland. Altogether, 132 pregnant and 92 postpartum women and 23 public health nurses (PHN participated in the study. The intervention consisted of individual counselling on physical activity and diet at five routine visits to a PHN and of an option for supervised group exercise until 37 weeks' gestation or ten months postpartum. The control clinics continued their usual care. The components of the feasibility evaluation were 1 recruitment and participation, 2 completion of data collection, 3 realization of the intervention and 4 the public health nurses' experiences. Results 1 The recruitment rate was slower than expected and the recruitment period had to be prolonged from the initially planned three months to six months. The average participation rate of eligible women at study enrolment was 77% and the drop-out rate 15%. 2 In total, 99% of the data on weight, physical activity and diet and 96% of the blood samples were obtained. 3 In the intervention clinics, 98% of the counselling sessions were realized, their contents and average durations were as intended, 87% of participants regularly completed the weekly records for physical activity and diet, and the average participation percentage in the group exercise sessions was 45%. 4 The PHNs regarded the extra training as a major advantage and the high additional workload as a disadvantage of the study. Conclusion The study protocol was mostly feasible to implement, which

  10. Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond

    OpenAIRE

    Jana Sawynok; Mary Lynch

    2014-01-01

    Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks) produces improvements in core domains for fibromyalgia (pai...

  11. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  12. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  13. Impact of industry collaboration on randomised controlled trials in oncology.

    Science.gov (United States)

    Linker, Anne; Yang, Annie; Roper, Nitin; Whitaker, Evans; Korenstein, Deborah

    2017-02-01

    Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT). We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88-6·83], p industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Effect of submucosal injection of dexamethasone after third molar surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Moraschini, V; Hidalgo, R; Porto Barboza, E dS

    2016-02-01

    The aim of this meta-analysis was to analyse the effectiveness of submucosal injection of dexamethasone to control the postoperative signs and symptoms resulting from impacted third molar surgery. An electronic search was conducted, without restriction on date or language, in the PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, and Web of Science databases until June 2015 . The eligibility criteria included non-randomized or randomized clinical trials in humans. After the search and selection process, eight articles were included. The fixed-effects or random-effects model, depending on heterogeneity, was built on the inverse-variance method used. The estimations of intervention were expressed as the mean difference (MD) in millimetres. The results of this meta-analysis suggest that the submucosal injection of dexamethasone presents a reduction in the postoperative signs and symptoms resulting from impacted third molar surgery, especially those associated with oedema and pain. In relation to trismus, the meta-analysis showed no statistically significant difference between dexamethasone and the placebo solution.

  15. Control groups in recent septic shock trials: a systematic review.

    Science.gov (United States)

    Pettilä, Ville; Hjortrup, Peter Buhl; Jakob, Stephan M; Wilkman, Erika; Perner, Anders; Takala, Jukka

    2016-12-01

    The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. We searched for original articles presenting randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58 % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2-17) were reported. Only 2 (8 %) trials provided adequate data to confirm that their control group treatment represented usual care. Recent trials in septic shock provide inadequate data on the control group treatment and hemodynamic values. We propose a standardized trial dataset to be created and validated, comprising characteristics of patient population, interventions administered, hemodynamic values achieved, surrogate organ dysfunction, and mortality outcomes, to allow better analysis and interpretation of future trial results.

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

    OpenAIRE

    Forster Anne; Young John; Barber Sally; Clegg Andrew; Iliffe Steve

    2011-01-01

    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 a...

  17. Safety of placebo controls in pediatric hypertension trials.

    Science.gov (United States)

    Smith, P Brian; Li, Jennifer S; Murphy, M Dianne; Califf, Robert M; Benjamin, Daniel K

    2008-04-01

    Many clinical trials, including those in pediatric populations, use a placebo arm for medical conditions for which there are readily available therapeutic interventions. Several short-term efficacy trials of antihypertensive medications performed in response to Food and Drug Administration-issued written requests have used a placebo arm; whether the use of a placebo arm is safe in children with hypertension is unknown. We sought to define the rates of adverse events in 10 short-term antihypertensive trials to determine whether these trials resulted in increased risk to pediatric patients receiving placebo. We combined patient-level data from 10 antihypertensive efficacy trials performed in pediatric patients that were submitted to the Food and Drug Administration from 1998 to 2005. We determined the number and type of all of the adverse events reported during the placebo-controlled portion of the clinical trials and compared these numbers between the patients who received placebo and those who received active drug. Among the 1707 children in the 10 studies, we observed no differences in the rates of adverse events reported between the patients who received placebo and those who received active drug. Only 5 patients suffered a serious adverse event during the trials; none were thought by the investigators to be related to study drug, and only 1 occurred in a patient receiving placebo. Short-term exposure to placebo in pediatric trials of antihypertensive medications appears to be safe.

  18. Drug interactions in controlled clinical trials.

    Science.gov (United States)

    Gershon, S

    1982-12-01

    As much information as possible should be obtained in clinical trials to assess possible interactions between test drugs and concomitant medications prescribed for other medical indications. Side effect profiles were compared in patients taking buspirone, mean = 20 mg/day; diazepam, 20 mg/day; clorazepate, 23 mg/day; and placebo, with or without concomitant medications. Approximately 1,000 anxious patients were included in the analysis; 700 received buspirone. The use of a variety of common medications did not affect the side effect profile in the buspirone, clorazepate, and placebo groups, but did increase the incidence of side effects in the diazepam group. The increased incidence of sedation noted with diazepam and clorazepate, however, was not due to concomitant medication.

  19. Comprehensive Geriatric Assessment for Prevention of Delirium After Hip Fracture: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Shields, Lynn; Henderson, Victoria; Caslake, Robert

    2017-07-01

    To assess the efficacy of comprehensive geriatric assessment (CGA) in prevention of delirium after hip fracture. Systematic review and metaanalysis. Ward based models on geriatrics wards and visiting team based models on orthopaedics wards were included. Four trials (three European, one U.S.; 973 participants) were identified. Two assessed ward-based, and two assessed team-based interventions. MEDLINE, EMBASE, CINAHL and PsycINFO databases; Clinicaltrials.gov; and the Central Register of Controlled Trials were searched. Reference lists from full-text articles were reviewed. Incidence of delirium was the primary outcome. Length of stay, delirium severity, institutionalization, long-term cognition and mortality were predefined secondary outcomes. Duration of delirium was included as a post hoc outcome. There was a significant reduction in delirium overall (relative risk (RR) = 0.81, 95% confidence interval (CI) = 0.69-0.94) in the intervention group. Post hoc subgroup analysis found this effect to be preserved in the team-based intervention group (RR = 0.77, 95% CI = 0.61-0.98) but not the ward-based group. No significant effect was observed on any secondary outcome. There was a reduction in the incidence of delirium after hip fracture with CGA. This is in keeping with results of non-randomized controlled trials and trials in other populations. Team-based interventions appeared superior in contrast to the Ellis CGA paper, but it is likely that heterogeneity in interventions and population studied affected this. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  20. A non-randomized controlled clinical trial on autologous chondrocyte implantation (ACI) in cartilage defects of the medial femoral condyle with or without high tibial osteotomy in patients with varus deformity of less than 5°

    DEFF Research Database (Denmark)

    Bode, Gerrit; Schmal, Hagen; Pestka, Jan M

    2013-01-01

    PURPOSE: High tibial osteotomy (HTO) is a recommended concomitant surgery when treating cartilage lesions of the medial femoral condyle (MFC). Varus deformities of 5° and more were considered an indication for HTO in patients with cartilage defects. This study compares clinical outcome in patients...

  1. Veterinary clinical research database for homeopathy: placebo-controlled trials.

    Science.gov (United States)

    Clausen, J; Albrecht, H; Mathie, R T

    2013-04-01

    Veterinary homeopathy has led a somewhat shadowy existence since its first introduction. Only in the last three decades has the number of clinical trials increased considerably. This literature is generally not well perceived, which may be partly a consequence of the diffuse and somewhat inaccessible nature of some of the relevant research publications. The Veterinary Clinical Research Database for Homeopathy (VetCR) was launched in 2006 to provide information on existing clinical research in veterinary homeopathy and to facilitate the preparation of systematic reviews. The aim of the present report is to provide an overview of this first database on clinical research in veterinary homeopathy, with a special focus on its content of placebo controlled clinical trials and summarising what is known about placebo effects in animals. In April 2012, the VetCR database contained 302 data records. Among these, 203 controlled trials were identified: 146 randomised and 57 non-randomised. In 97 of those 203 trials, the homeopathic medical intervention was compared to placebo. A program of formal systematic reviews of peer-reviewed randomised controlled trials in veterinary homeopathy is now underway; detailed findings from the program's data extraction and appraisal approach, including the assessment of trial quality (risk of bias), will be reported in due course. Copyright © 2012 Elsevier Ltd. All rights reserved.

  2. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

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

  3. Reducing bias in survival under non-random temporary emigration

    Science.gov (United States)

    Peñaloza, Claudia L.; Kendall, William L.; Langtimm, Catherine Ann

    2014-01-01

    Despite intensive monitoring, temporary emigration from the sampling area can induce bias severe enough for managers to discard life-history parameter estimates toward the terminus of the times series (terminal bias). Under random temporary emigration unbiased parameters can be estimated with CJS models. However, unmodeled Markovian temporary emigration causes bias in parameter estimates and an unobservable state is required to model this type of emigration. The robust design is most flexible when modeling temporary emigration, and partial solutions to mitigate bias have been identified, nonetheless there are conditions were terminal bias prevails. Long-lived species with high adult survival and highly variable non-random temporary emigration present terminal bias in survival estimates, despite being modeled with the robust design and suggested constraints. Because this bias is due to uncertainty about the fate of individuals that are undetected toward the end of the time series, solutions should involve using additional information on survival status or location of these individuals at that time. Using simulation, we evaluated the performance of models that jointly analyze robust design data and an additional source of ancillary data (predictive covariate on temporary emigration, telemetry, dead recovery, or auxiliary resightings) in reducing terminal bias in survival estimates. The auxiliary resighting and predictive covariate models reduced terminal bias the most. Additional telemetry data was effective at reducing terminal bias only when individuals were tracked for a minimum of two years. High adult survival of long-lived species made the joint model with recovery data ineffective at reducing terminal bias because of small-sample bias. The naïve constraint model (last and penultimate temporary emigration parameters made equal), was the least efficient, though still able to reduce terminal bias when compared to an unconstrained model. Joint analysis of several

  4. Activity monitor intervention to promote physical activity of physicians-in-training: randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Anne N Thorndike

    Full Text Available BACKGROUND: Physicians are expected to serve as role models for healthy lifestyles, but long work hours reduce time for healthy behaviors. A hospital-based physical activity intervention could improve physician health and increase counseling about exercise. METHODS: We conducted a two-phase intervention among 104 medical residents at a large hospital in Boston, Massachusetts. Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed (intervention or to a blinded monitor (control. Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback. Phase 1 outcomes were: 1 median steps/day and 2 proportion of days activity monitor worn. The Phase 2 outcome was mean steps/day on days monitor worn (≥500 steps/day. Physiologic measurements were collected at baseline and study end. Median steps/day were compared using Wilcoxon rank-sum tests. Mean steps were compared using repeated measures regression analyses. RESULTS: In Phase 1, intervention and control groups had similar activity (6369 vs. 6063 steps/day, p = 0.16 and compliance with wearing the monitor (77% vs. 77% of days, p = 0.73. In Phase 2 (team competition, residents recorded more steps/day than during Phase 1 (CONTROL: 7,971 vs. 7,567, p = 0.002; INTERVENTION: 7,832 vs. 7,739, p = 0.13. Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 (60% vs. 77%, p<0.001. Mean systolic blood pressure decreased (p = 0.004 and HDL cholesterol increased (p<0.001 among all participants at end of study compared to baseline. CONCLUSIONS: Although the activity monitor intervention did not have a major impact on activity or health, the high participation rates of busy residents and modest changes in steps, blood pressure, and HDL suggest that more

  5. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.

    Science.gov (United States)

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients.

  6. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry

    Science.gov (United States)

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Background Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. Methods We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Results Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Conclusion Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients. PMID:28192509

  7. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  8. 42 CFR 421.505 - Termination and extension of non-random prepayment complex medical review.

    Science.gov (United States)

    2010-10-01

    ... a provider or supplier must be on non-random prepayment complex medical review. There is no minimum... section, a contractor must terminate a provider or supplier from non-random prepayment complex medical... complex medical review if a provider or supplier stops billing the code under review, shifts billing...

  9. Medicare Program; termination of non-random prepayment complex medical review. Final rule.

    Science.gov (United States)

    2008-09-26

    This final rule implements requirements regarding the termination of non-random prepayment complex medical review as required under the Medicare Prescription Drug, Improvement and Modernization Act of 2003. This final rule sets forth the criteria CMS contractors will use for terminating a provider or supplier from non-random prepayment complex medical review.

  10. Chemotherapeutic trial to control enterobiasis in schoolchildren.

    Science.gov (United States)

    Yang, Y S; Kim, S W; Jung, S H; Huh, S; Lee, J H

    1997-12-01

    To assess several chemotherapeutic schemes for control of enterobiasis, 738 children in five primary schools in Chunchon, Korea, were studied from May 1994 to June 1995. They were divided into 6 groups by the schemes: treatment of once or twice a year; treatment of positive cases or of whole class students; treatment with or without family members. The overall egg positive rate before intervention was 17.5% out of 789 children. Treating all individuals in a class together with family members of positive cases brought better control efficacy than other schemes (p = 0.000). However, when egg positive rate is less than 30%, treating only egg positive cases also can reduce egg positive rate. The confounding factors for the enterobiasis control in primary schoolchildren were new-comer to a class and familial infection.

  11. Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial

    National Research Council Canada - National Science Library

    Garg, Amit X; Vincent, Jessica; Cuerden, Meaghan; Parikh, Chirag; Devereaux, P J; Teoh, Kevin; Yusuf, Salim; Hildebrand, Ainslie; Lamy, Andre; Zuo, Yunxia; Sessler, Daniel I; Shah, Pallav; Abbasi, Seyed Hesameddin; Quantz, Mackenzie; Yared, Jean-Pierre; Noiseux, Nicolas; Tagarakis, Georgios; Rochon, Antoine; Pogue, Janice; Walsh, Michael; Chan, Matthew T V; Lamontagne, Francois; Salehiomran, Abbas; Whitlock, Richard

    2014-01-01

    Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump...

  12. Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

    Directory of Open Access Journals (Sweden)

    Denise Thomson

    Full Text Available BACKGROUND: The objective of this study was to describe randomized controlled trials (RCTs and controlled clinical trials (CCTs in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. METHODOLOGY/PRINCIPAL FINDINGS: We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%, behavioural and psychiatric disorders (11.6%, neonatal critical care (11.4%, respiratory disorders (8.9%, non-critical neonatology (7.9%, and anaesthesia (6.5%. There were significantly fewer child-only studies (i.e., more mixed child and adult studies over time (P = 0.0460. The proportion of RCTs to CCTs increased significantly over time (P<0.0001, as did the proportion of multicentre trials (P = 0.002. Significant increases over time were found in methodological quality (Jadad score (P<0.0001, the proportion of double-blind studies (P<0.0001, and studies with adequate allocation concealment (P<0.0001. Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001, sample size calculations (P<0.0001, and intention-to-treat analysis (P<0.0001. However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003, and these studies were more likely to report positive conclusions (P = 0.028. CONCLUSIONS/SIGNIFICANCE: The quantity and quality of pediatric controlled trials has increased over time; however

  13. Weed Control Trials in Cottonwood Plantations

    Science.gov (United States)

    R. M. Krinard

    1964-01-01

    Weed control in the first year is essential for establishing a cottonwood plantation, for the young trees can neither survive nor grow well if they must compete with other plants. Once the light and moisture conditions are established in its favor, cottonwood becomes the fastest growing tree in the South.

  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. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  16. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials.

    Science.gov (United States)

    Kim, Young-Dae; Heo, In; Shin, Byung-Cheul; Crawford, Cindy; Kang, Hyung-Won; Lim, Jung-Hwa

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were "acupuncture" and "PTSD." No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  17. Surgical trials in oncology. the importance of quality control in the TME trial.

    Science.gov (United States)

    Klein Kranenbarg, E; van de Velde, C J H

    2002-05-01

    Results from randomised trials provide the best scientific evidence of efficacy or inefficacy of the therapy. The evaluation of surgical procedures involves problems in addition to those associated with medical experimentation. Surgery, unlike a pill, is not a standardised, reproducible entity, but a unique product whose details are defined by, for example, the skill of the surgeon. Quality assurance is important for treatment and also for data handling. The different treatments (surgery, pathology, radiotherapy, etc.) should be familiar to all participating physicians prior to the start of the trial. Instructions can be given by means of a well-written protocol, videotapes, workshops and instructors at the dissection table. The data collection and data check should be done by data managers and co-ordinators for the separate disciplines. Errors and missing data should be completed and feedback to the physician is essential. Close contact between an active co-ordinating data centre, including co-ordinators for the separate disciplines, and all participating physicians is essential to conduct a quality controlled multicentre, multidisciplinary trial. Continuous enthusiasm can be maintained by the organisation of regular workshops, distribution of newsletters and trial up-dates at scientific meetings. The efforts from all of the involved co-ordinators, data managers, instructors and physicians have resulted in a very successful trial with rapid accrual, good quality treatments and procedures, good quality data, and a high participation rate among hospitals and patients. Quality control is expensive and labour-intensive, but it is worthwhile.

  18. Randomized controlled trials – a matter of design

    Science.gov (United States)

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial. PMID:27354804

  19. Directional sensitivity of "first trial" reactions in human balance control.

    NARCIS (Netherlands)

    Oude Nijhuis, L.B.; Allum, J.H.J.; Borm, G.F.; Honegger, F.; Overeem, S.; Bloem, B.R.

    2009-01-01

    Support-surface movements are commonly used to examine balance control. Subjects typically receive a series of identical or randomly interspersed multidirectional balance perturbations and the atypical "first trial reaction" (evoked by the first perturbation) is often excluded from further analysis.

  20. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial.

    Science.gov (United States)

    Herr, Harry W

    2005-01-01

    In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial.

  1. A controlled trial of ambroxol in chronic bronchitis.

    Science.gov (United States)

    Guyatt, G H; Townsend, M; Kazim, F; Newhouse, M T

    1987-10-01

    Ambroxol is a mucolytic agent which is widely used in chronic bronchitis in Europe. We conducted a double-blind randomized controlled trial of ambroxol vs matched placebo in 90 patients with chronic bronchitis and difficulty clearing secretions. It was concluded that there was no advantage to taking ambroxol.

  2. Yoga in schizophrenia : a systematic review of randomised controlled trials

    NARCIS (Netherlands)

    Vancampfort, D.; Vansteelandt, K.; Scheewe, T.; Probst, M.; Knapen, J.; De Herdt, A.; De Hert, M.

    2012-01-01

    Vancampfort D, Vansteelandt K, Scheewe T, Probst M, Knapen J, De Herdt A, De Hert M. Yoga in schizophrenia: a systematic review of randomised controlled trials. Objective: The objective of this systematic review was to assess the effectiveness of yoga as a complementary treatment on general psychopa

  3. Amalgam and ART restorations in children: a controlled clinical trial

    NARCIS (Netherlands)

    Amorim, R.G. de; Leal, S.C.; Mulder, J.; Creugers, N.H.J.; Frencken, J.E.F.M.

    2014-01-01

    OBJECTIVES: The aims of this study were to compare 2-year cumulative survival rates of amalgam and atraumatic restorative treatment (ART) restorations in primary molars and to investigate the determinants of the survival rate of restorations. MATERIALS AND METHODS: A controlled clinical trial using

  4. Yoga in schizophrenia : a systematic review of randomised controlled trials

    NARCIS (Netherlands)

    Vancampfort, D.; Vansteelandt, K.; Scheewe, T.; Probst, M.; Knapen, J.; De Herdt, A.; De Hert, M.

    2012-01-01

    Vancampfort D, Vansteelandt K, Scheewe T, Probst M, Knapen J, De Herdt A, De Hert M. Yoga in schizophrenia: a systematic review of randomised controlled trials. Objective: The objective of this systematic review was to assess the effectiveness of yoga as a complementary treatment on general psychopa

  5. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    Science.gov (United States)

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  6. The effect of orthodontic referral guidelines: A randomised controlled trial

    OpenAIRE

    Conboy, Frances; O'Brien, K.

    2000-01-01

    Objective To develop and evaluate the effectiveness of referral guidelines for the referral of orthodontic patients to consultant and specialist practijioner orthodontists. Design Single centre randomised controlled trial with random allocation of referral guidelines for orthodontic treatment to general dental practitioners. Setting Hospital orthodontic departments and specialist orthodontic practices in Manchester and Stockport. Subjects General dental practitioners and the patients they ref...

  7. Asthma Self-Management Model: Randomized Controlled Trial

    Science.gov (United States)

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  8. Chemical Control of Pennesetum Purpureum Laboratory Trials

    Directory of Open Access Journals (Sweden)

    B.N Tripathi

    1977-10-01

    Full Text Available Dichloral urea, diethyl chloracetamide, nitrourea, chloralhydrate, sodium trichloroacetate, sodium borate, ammonium thiocynate, sodium arsenite, arsenic oxide-sulphuric acid mixture, sodium chlorate, maleic hydrazide and the salts containing inorganic ions Cu/sup 2+/, Co/sup 2+/, MoO/sub 4//sup 2-/ and Zn/sup 2+/ were tested in experimental plots for their phytotoxic activity on a hybrid variety of Pennesetum purpureum. Sodium borate (2500 Kg/hectare, Sodium arsenite (250 Kg/hectare and sodium chlorate (1000 Kg/hectare through soil and ammonium thiocyanate (100 Kg/hectare through direct spray function as growth retardants. Arsenic oxide-sulphuric acid (100 : 300 Kg/hectare spray kills the existing leaves. Sodium chlorate (250 Kg/hectare spray exerts phytocidal action on young plants (3 weeks. Maleic hydrazide (50 Kg/hectare exerts permanent growth suppressant action on older plants (height >=1 m and kills the existing leaves of younger plants (height=<0.5 m. Copper sulphate (100 Kg/hectare induces partial drying of existing leaves and cobalt sulphate in the same dose induces yellowing of leaves extending the period of growth beyond the season of maximum growth of the control. Ammonium molybdate and Zinc acetate in the same dose do not exert any perceptible effect.

  9. Placebo-controlled trials and the Declaration of Helsinki.

    Science.gov (United States)

    Lewis, John A; Jonsson, Bertil; Kreutz, Gottfried; Sampaio, Cristina; van Zwieten-Boot, Barbara

    2002-04-13

    A revised version of the Declaration of Helsinki, issued in October, 2000, remains a vital expression of medical ethics, and deserves unanimous support. A strict interpretation of the declaration seems to rule out clinical trials that use a placebo control group whenever licensed therapeutic methods already exist, preferring active controls. Although the efficacy of some new medicines can be satisfactorily established without the use of a placebo, for others the judicious use of placebo remains essential to establish their effectiveness.

  10. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  11. Calculating sample size in trials using historical controls.

    Science.gov (United States)

    Zhang, Song; Cao, Jing; Ahn, Chul

    2010-08-01

    Makuch and Simon [Sample size considerations for non-randomised comparative studies. J Chronic Dis 1980; 33: 175-81.] developed a sample size formula for historical control trials. When assessing power, they assumed the true control treatment effect to be equal to the observed effect from the historical control group. Many researchers have pointed out that the Makuch-Simon approach does not preserve the nominal power and type I error when considering the uncertainty in the true historical control treatment effect. To develop a sample size formula that properly accounts for the underlying randomness in the observations from the historical control group. We reveal the extremely skewed nature in the distributions of power and type I error, obtained over all the random realizations of the historical control data. The skewness motivates us to derive a sample size formula that controls the percentiles, instead of the means, of the power and type I error. A closed-form sample size formula is developed to control arbitrary percentiles of power and type I error for historical control trials. A simulation study further demonstrates that this approach preserves the operational characteristics in a more realistic scenario where the population variances are unknown and replaced by sample variances. The closed-form sample size formula is derived for continuous outcomes. The formula is more complicated for binary or survival time outcomes. We have derived a closed-form sample size formula that controls the percentiles instead of means of power and type I error in historical control trials, which have extremely skewed distributions over all the possible realizations of historical control data.

  12. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    Science.gov (United States)

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  13. The Sexunzipped trial: optimizing the design of online randomized controlled trials.

    Science.gov (United States)

    Bailey, Julia V; Pavlou, Menelaos; Copas, Andrew; McCarthy, Ona; Carswell, Ken; Rait, Greta; Hart, Graham; Nazareth, Irwin; Free, Caroline; French, Rebecca; Murray, Elizabeth

    2013-12-11

    Sexual health problems such as unwanted pregnancy and sexually transmitted infection are important public health concerns and there is huge potential for health promotion using digital interventions. Evaluations of digital interventions are increasingly conducted online. Trial administration and data collection online offers many advantages, but concerns remain over fraudulent registration to obtain compensation, the quality of self-reported data, and high attrition. This study addresses the feasibility of several dimensions of online trial design-recruitment, online consent, participant identity verification, randomization and concealment of allocation, online data collection, data quality, and retention at 3-month follow-up. Young people aged 16 to 20 years and resident in the United Kingdom were recruited to the "Sexunzipped" online trial between November 2010 and March 2011 (n=2036). Participants filled in baseline demographic and sexual health questionnaires online and were randomized to the Sexunzipped interactive intervention website or to an information-only control website. Participants were also randomly allocated to a postal request (or no request) for a urine sample for genital chlamydia testing and receipt of a lower (£10/US$16) or higher (£20/US$32) value shopping voucher compensation for 3-month outcome data. The majority of the 2006 valid participants (90.98%, 1825/2006) were aged between 18 and 20 years at enrolment, from all four countries in the United Kingdom. Most were white (89.98%, 1805/2006), most were in school or training (77.48%, 1545/1994), and 62.81% (1260/2006) of the sample were female. In total, 3.88% (79/2036) of registrations appeared to be invalid and another 4.00% (81/2006) of participants gave inconsistent responses within the questionnaire. The higher value compensation (£20/US$32) increased response rates by 6-10%, boosting retention at 3 months to 77.2% (166/215) for submission of online self-reported sexual health

  14. Trial-to-trial adaptation in control of arm reaching and standing posture.

    Science.gov (United States)

    Pienciak-Siewert, Alison; Horan, Dylan P; Ahmed, Alaa A

    2016-12-01

    Classical theories of motor learning hypothesize that adaptation is driven by sensorimotor error; this is supported by studies of arm and eye movements that have shown that trial-to-trial adaptation increases with error. Studies of postural control have shown that anticipatory postural adjustments increase with the magnitude of a perturbation. However, differences in adaptation have been observed between the two modalities, possibly due to either the inherent instability or sensory uncertainty in standing posture. Therefore, we hypothesized that trial-to-trial adaptation in posture should be driven by error, similar to what is observed in arm reaching, but the nature of the relationship between error and adaptation may differ. Here we investigated trial-to-trial adaptation of arm reaching and postural control concurrently; subjects made reaching movements in a novel dynamic environment of varying strengths, while standing and holding the handle of a force-generating robotic arm. We found that error and adaptation increased with perturbation strength in both arm and posture. Furthermore, in both modalities, adaptation showed a significant correlation with error magnitude. Our results indicate that adaptation scales proportionally with error in the arm and near proportionally in posture. In posture only, adaptation was not sensitive to small error sizes, which were similar in size to errors experienced in unperturbed baseline movements due to inherent variability. This finding may be explained as an effect of uncertainty about the source of small errors. Our findings suggest that in rehabilitation, postural error size should be considered relative to the magnitude of inherent movement variability.

  15. Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond

    Directory of Open Access Journals (Sweden)

    Jana Sawynok

    2014-01-01

    Full Text Available Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function that are maintained at 4–6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6–12 months indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects.

  16. Randomized Controlled Trials of Add-On Antidepressants in Schizophrenia.

    Science.gov (United States)

    Terevnikov, Viacheslav; Joffe, Grigori; Stenberg, Jan-Henry

    2015-05-19

    Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors' efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups--plausibly due to differences in the mechanisms of action. Antidepressants may not worsen the course of psychosis. Better designed

  17. Impact of Length or Relevance of Questionnaires on Attrition in Online Trials: Randomized Controlled Trial

    Science.gov (United States)

    Kalaitzaki, Eleftheria; White, Ian R; Khadjesari, Zarnie; Murray, Elizabeth; Linke, Stuart; Thompson, Simon G; Godfrey, Christine; Wallace, Paul

    2011-01-01

    Background There has been limited study of factors influencing response rates and attrition in online research. Online experiments were nested within the pilot (study 1, n = 3780) and main trial (study 2, n = 2667) phases of an evaluation of a Web-based intervention for hazardous drinkers: the Down Your Drink randomized controlled trial (DYD-RCT). Objectives The objective was to determine whether differences in the length and relevance of questionnaires can impact upon loss to follow-up in online trials. Methods A randomized controlled trial design was used. All participants who consented to enter DYD-RCT and completed the primary outcome questionnaires were randomized to complete one of four secondary outcome questionnaires at baseline and at follow-up. These questionnaires varied in length (additional 23 or 34 versus 10 items) and relevance (alcohol problems versus mental health). The outcome measure was the proportion of participants who completed follow-up at each of two follow-up intervals: study 1 after 1 and 3 months and study 2 after 3 and 12 months. Results At all four follow-up intervals there were no significant effects of additional questionnaire length on follow-up. Randomization to the less relevant questionnaire resulted in significantly lower rates of follow-up in two of the four assessments made (absolute difference of 4%, 95% confidence interval [CI] 0%-8%, in both study 1 after 1 month and in study 2 after 12 months). A post hoc pooled analysis across all four follow-up intervals found this effect of marginal statistical significance (unadjusted difference, 3%, range 1%-5%, P = .01; difference adjusted for prespecified covariates, 3%, range 0%-5%, P = .05). Conclusions Apparently minor differences in study design decisions may have a measurable impact on attrition in trials. Further investigation is warranted of the impact of the relevance of outcome measures on follow-up rates and, more broadly, of the consequences of what we ask participants to

  18. 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

  19. Clinical trials of antihypertensives: Nature of control and design

    Directory of Open Access Journals (Sweden)

    Bhaswat S Chakraborty

    2011-01-01

    Full Text Available This paper reviews the critical issues in the control and design of antihypertension (anti-HT clinical trials. The international guidelines and current clinical and biostatistical practices were reviewed for relevant clinical, design, end-point assessments and regulatory issues. The results are grouped mainly into ethical, protocol and assessment issues. Ethical issues arise as placebo-controlled trials (PCTs for HT-lowering agents in patients with moderate to severe HT are undertaken. Patients with organ damage due to HT should not be included in long-term PCT. Active-control trials, however, are suitable for all randomized subsets of patients, including men and women, and different ethnic and age groups. Severity subgroups must be studied separately with consideration to specific study design. Mortality and morbidity outcome studies are not required in anti-HT trials except when significant mortality and cardiovascular morbidity are suspected. Generally, changes in both systolic and diastolic blood pressures (BP at the end of the dosing interval from the baseline are compared between the active and the control arms as the primary endpoint of anti-HT effect. Onset of the anti-HT effect can be studied as the secondary endpoint. For maintenance of efficacy, long-term studies of ≥6 months need to be undertaken. Error-free measurement of BP is a serious issue as spontaneous changes in BP are large and active drug effect on diastolic BP is often small. Placebo-controlled short-term studies (of ~12 weeks for dose-response and titration are very useful. Safety studies must be very vigilant on hypotension, orthostatic hypotension and effects on heart. In dose-response studies, at least three doses in addition to placebo should be used to well characterize the benefits and side-effects.

  20. Incomplete categorical data design non-randomized response techniques for sensitive questions in surveys

    CERN Document Server

    Tian, Guo-Liang

    2013-01-01

    Respondents to survey questions involving sensitive information, such as sexual behavior, illegal drug usage, tax evasion, and income, may refuse to answer the questions or provide untruthful answers to protect their privacy. This creates a challenge in drawing valid inferences from potentially inaccurate data. Addressing this difficulty, non-randomized response approaches enable sample survey practitioners and applied statisticians to protect the privacy of respondents and properly analyze the gathered data.Incomplete Categorical Data Design: Non-Randomized Response Techniqu

  1. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Craig Fiona F

    2012-04-01

    Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day to prednisolone (0.75 mg/kg/day. A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size

  2. 西罗莫司在肾移植术后早期计划性切换的前瞻性对照研究%Early conversion from calcineurin inhibitor to sirolimusto after renal transplantation:a prospective,open-label and non-randomized control study

    Institute of Scientific and Technical Information of China (English)

    黄洪锋; 谢文卿; 吴建永; 徐莹; 余献平; 任萍萍; 陈江华

    2014-01-01

    Objective To explore the efficacy and safety of designed early conversion from calcineurin inhibitor (CNI) to sirolimus (SRL) as major immunosuppressive therapy in renal transplant recipients with stable renal function.Methods A prospective,open-label and non-randomized control study was performed for 112 renal transplant recipients (3-6 months post-operation) with stable renal function between June 2008 and June 2011.The patients in SRL group (n =57) switched to sirolimus while those in CNI group (n =55) continued CNI.The dosing of mycophenolate mofetil and steroids had no change.They were followed up for at least 24 months to evaluate the acute rejection,patient and graft survival,renal function,estimated glomerular filtration rate (eGFR),blood lipids,blood glucose,liver function and urinary protein at 1,6,12 and 24 months after inclusion.Adverse events were also recorded.Results The serum creatinine of SRL group decreased significantly after conversion ((89.2 ± 24.7),(87.6 ± 23.8),(86.1 ±20.4),(86.7 ± 19.7) vs(117.0 ± 16.3) μ.mol/L,all P < 0.05).CNI group showed no improvement of renal function.SRL group had a significantly higher eGFR than CNI group (P < 0.05).Among 3 cases of acute rejection,there were 2 in SRL group and 1 in CNI group (P > 0.05).Blood lipids in SRL group increased significantly at 1 month after conversion (P < 0.05) and reverted back to average level after intervention (P > 0.05).SRL group had a drop of hemoglobin level within the normal range.Two patients in SRL group developed hypokalemia and another 2 patients had oral ulcer.They all improved after treatment.During follow-ups,1 case of mild proteinuria was found in SIR group.Three patients were diagnosed with diabetes (1 in SRL group vs 2 in CNI group).Conclusions Early conversion from CNI to SRL as major immunosuppressive therapy in renal transplant recipients with stable renal function further improves renal function.There is no higher rate of acute rejection during

  3. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol

    OpenAIRE

    Cox, Helen; Tilbrook, Helen; Aplin, John; Chuang, Ling-Hsiang; Hewitt, Catherine; Jayakody, Shalmini; Semlyen, Anna; Soares, Marta O; Torgerson, David; Trewhela, Alison; Watt, Ian; Worthy, Gill

    2010-01-01

    A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is...

  4. Safety and efficacy of combination therapy of interferon-alpha2 + JAK1-2 Inhibitor in the philadelphia-negative chronic myeloproliferative neoplasms. Preliminary results from the danish combi-trial-an open label, single arm, non-randomized multicenter phase II study

    DEFF Research Database (Denmark)

    Mikkelsen, S. U.; Kjaer, L.; Skov, V.

    2015-01-01

    Background: The Philadelphia-negative, chronic myeloproliferative neoplasms (MPN) include essential thrombocythemia (ET), polycythemia vera (PV) and primary myelofibrosis (MF) (PMF). Chronic inflammation and a deregulated immune system are considered important for clonal evolution and disease....... Hct control without phlebotomy was achieved by week 4 in 78 % of pts (7 of 9), who at baseline had an elevated hct. Only 3 pts required a total of 3 phlebotomies after initiation of CT. In Figure 1 median hct levels at 0, 1, 3, 6 months are shown. Overall, complete response (CR) was achieved as best......) or major response (n=2) was achieved in 4 pts (57.1%) by week 2 or 1 month, and NR in 3 pts (42.8%). Among PPV-MF pts, 2 pts (66.7%) achieved CR and 1 patient (33,3%) PR by week 2. Furthermore, JAK2V617F% declined significantly as depicted in Figure 2 (JAK2V617F% over time for each patient) and 3 (median...

  5. Is sham laser a valid control for acupuncture trials?

    Science.gov (United States)

    Irnich, Dominik; Salih, Norbert; Offenbächer, Martin; Fleckenstein, Johannes

    2011-01-01

    Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point) and sham laser (red light) treatment at three acupuncture points (LI4, LU7 and LR3) in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation). We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44%) healthy volunteers (age: 28 ± 10.7 years) identified the used laser device after the first session and 14 (41%) after the second session. Hence, both treatments were undistinguishable (P = .26). Deqi-like sensations occurred in 46% of active laser (2.34 VAS) and in 49.0% of sham laser beams (2.49 VAS). The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se.

  6. Is Sham Laser a Valid Control for Acupuncture Trials?

    Directory of Open Access Journals (Sweden)

    Dominik Irnich

    2011-01-01

    Full Text Available Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point and sham laser (red light treatment at three acupuncture points (LI4, LU7 and LR3 in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation. We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44% healthy volunteers (age: 28 ± 10.7 years identified the used laser device after the first session and 14 (41% after the second session. Hence, both treatments were undistinguishable (P = .26. Deqi-like sensations occurred in 46% of active laser (2.34 VAS and in 49.0% of sham laser beams (2.49 VAS. The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se.

  7. Probiotics in the prevention of eczema: a randomised controlled trial

    OpenAIRE

    Allen, Stephen J; Jordan, Sue; Storey, Melanie; Catherine A Thornton; Gravenor, Michael B.; Garaiova, Iveta; Plummer, Susan F; Wang, Duolao; Morgan, Gareth

    2014-01-01

    Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebo-controlled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 a...

  8. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  9. Genetic susceptibility testing and readiness to control weight: Results from a randomized controlled trial

    NARCIS (Netherlands)

    Meisel, S.F.; Beeken, R.J.; Jaarsveld, C.H.M. van; Wardle, J.

    2015-01-01

    OBJECTIVE: To test the hypothesis that adding obesity gene feedback (FTO) to simple weight control advice at a life stage with raised risk of weight gain (university) increases readiness to control weight. METHODS: Individually randomized controlled trial comparing the effect of: (i) simple weight c

  10. Should desperate volunteers be included in randomised controlled trials?

    Science.gov (United States)

    Allmark, P; Mason, S

    2006-09-01

    Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

  11. Electrocardiogram ST Analysis During Labor : A Systematic Review and Meta-analysis of Randomized Controlled Trials

    NARCIS (Netherlands)

    Saccone, Gabriele; Schuit, Ewoud; Amer-Wåhlin, Isis; Xodo, Serena; Berghella, Vincenzo

    2016-01-01

    OBJECTIVE: To compare the effectiveness of cardiotocography plus ST analysis with cardiotocography alone during labor. DATA SOURCES: Randomized controlled trials were identified by searching electronic databases. METHODS OF STUDY SELECTION: We included all randomized controlled trials comparing intr

  12. Electrocardiogram ST Analysis During Labor : A Systematic Review and Meta-analysis of Randomized Controlled Trials

    NARCIS (Netherlands)

    Saccone, Gabriele; Schuit, Ewoud; Amer-Wåhlin, Isis; Xodo, Serena; Berghella, Vincenzo

    OBJECTIVE: To compare the effectiveness of cardiotocography plus ST analysis with cardiotocography alone during labor. DATA SOURCES: Randomized controlled trials were identified by searching electronic databases. METHODS OF STUDY SELECTION: We included all randomized controlled trials comparing

  13. The Asthma Control Questionnaire as a clinical trial endpoint

    DEFF Research Database (Denmark)

    Barnes, P J; Casale, T B; Dahl, Ronald;

    2014-01-01

    The goal of asthma treatment is to control the disease according to guidelines issued by bodies such as the Global Initiative for Asthma. Effective control is dependent upon evaluation of symptoms, initiation of appropriate treatment and minimization of the progressive adverse effects...... of the disease and its therapies. Although individual outcome measures have been shown to correlate with asthma control, composite endpoints are preferred to enable more accurate and robust monitoring of the health of the individual patient. A number of validated instruments are utilized to capture...... these component endpoints; however, there is no consensus on the optimal instrument for use in clinical trials. The Asthma Control Questionnaire (ACQ) has been shown to be a valid, reliable instrument that allows accurate and reproducible assessment of asthma control that compares favourably with other commonly...

  14. 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

  15. Challenges in randomized controlled trials and emerging multiple sclerosis therapeutics.

    Science.gov (United States)

    Huang, DeRen

    2015-12-01

    The remarkable global development of disease-modifying therapies (DMTs) specific for multiple sclerosis (MS) has significantly reduced the frequency of relapse, slowed the progression of disability, and improved the quality of life in patients with MS. With increasing numbers of approved DMTs, neurologists in North America and Europe are able to present multiple treatment options to their patients to achieve a better therapeutic outcome, and in many cases, no evidence of disease activity. MS patients have improved accessibility to various DMTs at no or minimal out-of-pocket cost. The ethical guidelines defined by the Edinburgh revision of the Declaration of Helsinki strongly discourage the use of placebo control groups in modern MS clinical trials. The use of an active comparator control group increases the number of participants in each group that is essential to achieve statistical significance, thus further increasing the difficulty of completing randomized controlled trials (RCTs) for the development of new MS therapies. There is evidence of a high prevalence of MS and a large number of patients in Asia. The belief of the existence of Asian types of MS that are distinct from Western types, and regulatory policies are among the reasons why DMTs are limited in most Asian countries. Lack of access to approved DMTs provides a good opportunity for clinical trials that are designed for the development of new MS therapies. Recently, data from RCTs have demonstrated excellent recruitment of participants and the completion of multi-nation and single-nation MS trials within this region. Recent studies using the McDonald MS diagnostic criteria carefully excluded patients with neuromyelitis optica (NMO) and NMO spectrum disorder, and demonstrated that patients with MS in Asia have clinical characteristics and treatment responses similar to those in Western countries.

  16. Controlled human malaria infection trials: How tandems of trust and control construct scientific knowledge.

    Science.gov (United States)

    Bijker, Else M; Sauerwein, Robert W; Bijker, Wiebe E

    2016-02-01

    Controlled human malaria infections are clinical trials in which healthy volunteers are deliberately infected with malaria under controlled conditions. Controlled human malaria infections are complex clinical trials: many different groups and institutions are involved, and several complex technologies are required to function together. This functioning together of technologies, people, and institutions is under special pressure because of potential risks to the volunteers. In this article, the authors use controlled human malaria infections as a strategic research site to study the use of control, the role of trust, and the interactions between trust and control in the construction of scientific knowledge. The authors argue that tandems of trust and control play a central role in the successful execution of clinical trials and the construction of scientific knowledge. More specifically, two aspects of tandems of trust and control will be highlighted: tandems are sites where trust and control coproduce each other, and tandems link the personal, the technical, and the institutional domains. Understanding tandems of trust and control results in setting some agendas for both clinical trial research and science and technology studies.

  17. A Non-Random Walk Down Hollywood Boulevard

    DEFF Research Database (Denmark)

    Lepori, Gabriele

    affect (i.e. grief, proxied by the death of Hollywood Walk of Fame celebrities) on people’s willingness to invest in risky assets (proxied by the daily performance of the U.S. stock market). Using a sample of 1,374 celebrity deaths over the period 1926-2009 and controlling for seasonalities, economic....../environmental factors, and market liquidity, I find that the death of popular and beloved celebrities is immediately followed by a 16 basis point increase in stock returns, which is consistent with a rise in the net demand for risky instruments. I also find evidence that the size of this celebrity-death effect...... is increasing in the popularity/media coverage of the celebrity in question, and is larger for stocks that are more affected by investor sentiment. Overall, my findings are consistent with the lab research on the affect management model, which maintains that incidental negative affect promotes risk...

  18. Difficulties in recruitment for a randomized controlled trial involving hysterosalpingography

    Directory of Open Access Journals (Sweden)

    Helmerhorst Frans M

    2006-06-01

    Full Text Available Abstract Background The usefulness of hysterosalpingography (HSG as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records. Results Out of 759 women, a total of 127 (17% agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%. Other reasons were inattentive clinicians (3% and patient-associated reasons (24%. Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure. Conclusion Almost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial.

  19. Sample size in orthodontic randomized controlled trials: are numbers justified?

    Science.gov (United States)

    Koletsi, Despina; Pandis, Nikolaos; Fleming, Padhraig S

    2014-02-01

    Sample size calculations are advocated by the Consolidated Standards of Reporting Trials (CONSORT) group to justify sample sizes in randomized controlled trials (RCTs). This study aimed to analyse the reporting of sample size calculations in trials published as RCTs in orthodontic speciality journals. The performance of sample size calculations was assessed and calculations verified where possible. Related aspects, including number of authors; parallel, split-mouth, or other design; single- or multi-centre study; region of publication; type of data analysis (intention-to-treat or per-protocol basis); and number of participants recruited and lost to follow-up, were considered. Of 139 RCTs identified, complete sample size calculations were reported in 41 studies (29.5 per cent). Parallel designs were typically adopted (n = 113; 81 per cent), with 80 per cent (n = 111) involving two arms and 16 per cent having three arms. Data analysis was conducted on an intention-to-treat (ITT) basis in a small minority of studies (n = 18; 13 per cent). According to the calculations presented, overall, a median of 46 participants were required to demonstrate sufficient power to highlight meaningful differences (typically at a power of 80 per cent). The median number of participants recruited was 60, with a median of 4 participants being lost to follow-up. Our finding indicates good agreement between projected numbers required and those verified (median discrepancy: 5.3 per cent), although only a minority of trials (29.5 per cent) could be examined. Although sample size calculations are often reported in trials published as RCTs in orthodontic speciality journals, presentation is suboptimal and in need of significant improvement.

  20. Randomized, placebo-controlled trials of dichlorphenamide in periodic paralysis.

    Science.gov (United States)

    Sansone, Valeria A; Burge, James; McDermott, Michael P; Smith, Patty C; Herr, Barbara; Tawil, Rabi; Pandya, Shree; Kissel, John; Ciafaloni, Emma; Shieh, Perry; Ralph, Jeffrey W; Amato, Antony; Cannon, Steve C; Trivedi, Jaya; Barohn, Richard; Crum, Brian; Mitsumoto, Hiroshi; Pestronk, Alan; Meola, Giovanni; Conwit, Robin; Hanna, Michael G; Griggs, Robert C

    2016-04-12

    To determine the short-term and long-term effects of dichlorphenamide (DCP) on attack frequency and quality of life in hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis. Two multicenter randomized, double-blind, placebo-controlled trials lasted 9 weeks (Class I evidence), followed by a 1-year extension phase in which all participants received DCP. Forty-four HOP and 21 HYP participants participated. The primary outcome variable was the average number of attacks per week over the final 8 weeks of the double-blind phase. The median attack rate was lower in HOP participants on DCP than in participants on placebo (0.3 vs 2.4, p = 0.02). The 9-week mean change in the Physical Component Summary score of the Short Form-36 was also better in HOP participants receiving DCP (treatment effect = 7.29 points, 95% confidence interval 2.26 to 12.32, p = 0.006). The median attack rate was also lower in HYP participants on DCP (0.9 vs 4.8) than in participants on placebo, but the difference in median attack rate was not significant (p = 0.10). There were no significant effects of DCP on muscle strength or muscle mass in either trial. The most common adverse events in both trials were paresthesia (47% DCP vs 14% placebo, both trials combined) and confusion (19% DCP vs 7% placebo, both trials combined). DCP is effective in reducing the attack frequency, is safe, and improves quality of life in HOP periodic paralysis. These studies provide Class I evidence that DCP significantly reduces attack frequency in HOP but lacked the precision to support either efficacy or lack of efficacy of DCP in HYP. © 2016 American Academy of Neurology.

  1. Randomized, placebo-controlled trials of dichlorphenamide in periodic paralysis

    Science.gov (United States)

    Burge, James; McDermott, Michael P.; Smith, Patty C.; Herr, Barbara; Tawil, Rabi; Pandya, Shree; Kissel, John; Ciafaloni, Emma; Shieh, Perry; Ralph, Jeffrey W.; Amato, Antony; Cannon, Steve C.; Trivedi, Jaya; Barohn, Richard; Crum, Brian; Mitsumoto, Hiroshi; Pestronk, Alan; Meola, Giovanni; Conwit, Robin; Hanna, Michael G.; Griggs, Robert C.

    2016-01-01

    Objective: To determine the short-term and long-term effects of dichlorphenamide (DCP) on attack frequency and quality of life in hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis. Methods: Two multicenter randomized, double-blind, placebo-controlled trials lasted 9 weeks (Class I evidence), followed by a 1-year extension phase in which all participants received DCP. Forty-four HOP and 21 HYP participants participated. The primary outcome variable was the average number of attacks per week over the final 8 weeks of the double-blind phase. Results: The median attack rate was lower in HOP participants on DCP than in participants on placebo (0.3 vs 2.4, p = 0.02). The 9-week mean change in the Physical Component Summary score of the Short Form–36 was also better in HOP participants receiving DCP (treatment effect = 7.29 points, 95% confidence interval 2.26 to 12.32, p = 0.006). The median attack rate was also lower in HYP participants on DCP (0.9 vs 4.8) than in participants on placebo, but the difference in median attack rate was not significant (p = 0.10). There were no significant effects of DCP on muscle strength or muscle mass in either trial. The most common adverse events in both trials were paresthesia (47% DCP vs 14% placebo, both trials combined) and confusion (19% DCP vs 7% placebo, both trials combined). Conclusions: DCP is effective in reducing the attack frequency, is safe, and improves quality of life in HOP periodic paralysis. Classification of evidence: These studies provide Class I evidence that DCP significantly reduces attack frequency in HOP but lacked the precision to support either efficacy or lack of efficacy of DCP in HYP. PMID:26865514

  2. Directional sensitivity of "first trial" reactions in human balance control.

    Science.gov (United States)

    Oude Nijhuis, Lars B; Allum, John H J; Borm, George F; Honegger, Flurin; Overeem, Sebastiaan; Bloem, Bastiaan R

    2009-06-01

    Support-surface movements are commonly used to examine balance control. Subjects typically receive a series of identical or randomly interspersed multidirectional balance perturbations and the atypical "first trial reaction" (evoked by the first perturbation) is often excluded from further analysis. However, this procedure may obscure vital information about neurophysiological mechanisms associated with the first perturbation and, by analogy, fully unexpected falls. We studied first trial reactions, aiming to clarify their directional impact on postural control and to characterize the underlying neurophysiological substrate. We instructed 36 subjects to maintain balance following support-surface rotations in six different directions. Perturbations in each direction were delivered in blocks, consisting of 10 serial stimuli. Full body kinematics, surface reactive forces, and electromyographic (EMG) responses were recorded. Regardless of direction, for the very first rotation, displacement of the center of mass was 15% larger compared with the ensuing nine identical rotations (P postural instability, mainly due to increased response amplitudes. Although rapid habituation occurs following presentation of identical stimuli, subjects immediately become unstable again when the perturbation direction suddenly changes. Excessive responses due to a failure to combine proprioceptive and vestibular cues effectively may explain this instability seen with first trials, particularly when falling backward.

  3. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Review of Randomized Controlled Trials of Massage in Preterm Infants

    Directory of Open Access Journals (Sweden)

    Anna-Kaisa Niemi

    2017-04-01

    Full Text Available Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants.

  5. Financial incentives for smoking cessation in pregnancy: randomised controlled trial.

    Science.gov (United States)

    Tappin, David; Bauld, Linda; Purves, David; Boyd, Kathleen; Sinclair, Lesley; MacAskill, Susan; McKell, Jennifer; Friel, Brenda; McConnachie, Alex; de Caestecker, Linda; Tannahill, Carol; Radley, Andrew; Coleman, Tim

    2015-01-27

    To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit. Phase II therapeutic exploratory single centre, individually randomised controlled parallel group superiority trial. One large health board area with a materially deprived, inner city population in the west of Scotland, United Kingdom. 612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking, at least 16 years of age, less than 24 weeks pregnant, and had an exhaled carbon monoxide breath test result of 7 ppm or more. 306 women were randomised to incentives and 306 to control. The control group received routine care, which was the offer of a face to face appointment to discuss smoking and cessation and, for those who attended and set a quit date, the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services, and four, weekly support phone calls. The intervention group received routine care plus the offer of up to £400 of shopping vouchers: £50 for attending a face to face appointment and setting a quit date; then another £50 if at four weeks' post-quit date exhaled carbon monoxide confirmed quitting; a further £100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks; a final £200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks' gestation. The primary outcome was cotinine verified cessation at 34-38 weeks' gestation through saliva (incentives were documented. Significantly more smokers in the incentives group than control group stopped smoking: 69 (22.5%) versus 26 (8.6%). The relative risk of not smoking at the end of pregnancy was 2.63 (95% confidence interval 1.73 to 4.01) Pincentives need to be offered to achieve one extra quitter in late pregnancy) was 7.2 (95% confidence interval 5.1 to 12.2). The mean birth weight was 3140 g (SD 600 g) in the incentives group

  6. Randomized controlled trials – a matter of design

    Directory of Open Access Journals (Sweden)

    Spieth PM

    2016-06-01

    Full Text Available Peter Markus Spieth,1,2 Anne Sophie Kubasch,3 Ana Isabel Penzlin,4 Ben Min-Woo Illigens,2,5 Kristian Barlinn,6 Timo Siepmann2,6,7 1Department of Anesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, 2Center for Clinical Research and Management Education, Division of Health Care Sciences, Dresden International University, 3Pediatric Rheumatology and Immunology, Children’s Hospital, University Hospital Carl Gustav Carus, Technische Universität Dresden, 4Institute of Clinical Pharmacology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; 5Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; 6Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; 7Radcliffe Department of Medicine, John Radcliffe Hospital, University of Oxford, Oxford, Oxfordshire, UK Abstract: Randomized controlled trials (RCTs are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1 clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2 both significant and nonsignificant results should be objectively

  7. The Declaration of Helsinki and clinical trials: a focus on placebo-controlled trials in schizophrenia.

    Science.gov (United States)

    Carpenter, William T; Appelbaum, Paul S; Levine, Robert J

    2003-02-01

    The authors' goal was to consider ethical approaches to placebo-controlled clinical trials in the light of the evolving Declaration of Helsinki, with special attention to applications to research on schizophrenia. They review the Helsinki position on placebos, including the 2002 Clarification, exploring the potential negative effects of banning placebos in studies involving conditions for which at least partially effective treatments exist. The Clarification is examined as an approach to this issue that, in contrast to earlier formulations, better acknowledges the complexity of clinical research and the need for protocol-specific determinations. Placebo controls in schizophrenia studies are used to illustrate issues relevant to all clinical research on therapeutic interventions. The Helsinki Clarification provides a basis for operationalizing criteria for review of placebo use in clinical trials. Six criteria are proposed for judging the ethical acceptability of placebo controls, including the likelihood that the intervention being tested will have clinically significant advantages over existing treatments, the presence of compelling reasons for placebo use, subject selection that minimizes the possibility of serious adverse consequences, and a risk-versus-benefit analysis that favors the advantages from placebo use over the risks to subjects. The Helsinki Clarification constitutes an important advance in international approaches to placebo use, requiring protocol-by-protocol judgments on complex issues of clinical research ethics. When operationalized, it provides review boards with a useful methodology for reaching determinations on the appropriateness of placebo controls in particular studies.

  8. A randomized controlled trial to promote volunteering in older adults.

    Science.gov (United States)

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention.

  9. Radonexposure with the treatment of rheumatic diseases - randomized controlled trials

    Energy Technology Data Exchange (ETDEWEB)

    Falkenbach, A. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria)]|[Forschungsinstitut Gastein, Bad Gastein (Austria); Kovac, J.; Brandmaier, P. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria); Soto, J. [Dept. of Medical Physics, Univ. of Cantabria (Spain)

    2001-07-01

    The objective was to investigate whether there is evidence for the effectiveness of radon therapy in the treatment of rheumatic diseases. Method: Medline and MedKur databases were searched for randomised controlled clinical trials. Radon therapy centres and experts in the field were contacted, proceedings were hand-searched and bibliographies were checked for references of potential impact. Four clinical trials evaluating the effect of radon in patients suffering from rheumatic diseases with no or only a small number of drop-outs met the inclusion criteria. In patients with degenerative disease of the spine and large joints, two trials [1,2] reported less pain on pressure of painful paraspinal muscle points after a series of radon baths at a concentration of 0.8 kBq/L and 3 kBq/L, respectively. The alleviation of pain was most pronounced in the weeks following the treatment period. [3]. At six months follow-up serial immersion in combined radon and CO{sub 2} baths reduced pain and functional restrictions in patients with rheumatoid arthritis (n=60) more effectively than bathing in CO{sub 2} only. [4] In 130 patients with ankylosing spondylitis a complex rehabilitation program at a health resort (group 1 and 2) showed greater and longer-lasting differences to a control group staying at home (group 3), if speleotherapeutic radon exposure (group 1) was added (as compared to an added sauna treatment, group 2). Conclusion: The four trials meeting the inclusion criteria showed beneficial effects of radon therapy compared to interventions without radon exposure. Up to nine months after the treatment period significantly better results were observed, if radon therapy is added. (orig.)

  10. A Randomised Controlled Trial of complete denture impression materials

    Science.gov (United States)

    Hyde, T.P.; Craddock, H.L.; Gray, J.C.; Pavitt, S.H.; Hulme, C.; Godfrey, M.; Fernandez, C.; Navarro-Coy, N.; Dillon, S.; Wright, J.; Brown, S.; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p silicone impressions were preferred by patients. Clinical significance Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

  11. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

    OpenAIRE

    Jing-Yu Tan; Suen, Lorna K P; Tao Wang; Alexander Molassiotis

    2015-01-01

    Objectives To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method. Methods Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from in...

  12. Individual nutrition therapy and exercise regime: A controlled trial of injured, vulnerable elderly (INTERACTIVE trial

    Directory of Open Access Journals (Sweden)

    Whitehead Craig

    2008-02-01

    Full Text Available Abstract Background Proximal femoral fractures are amongst the most devastating consequences of osteoporosis and injurious accidental falls with 25–35% of patients dying in the first year post-fracture. Effective rehabilitation strategies are evolving however, despite established associations between nutrition, mobility, strength and strength-related functional outcomes; there has been only one small study with older adults immediately following fragility fracture where a combination of both exercise and nutrition have been provided. The aim of the INTERACTIVE trial is to establish whether a six month, individualised exercise and nutrition program commencing within fourteen days of surgery for proximal femur fracture, results in clinically and statistically significant improvements in physical function, body composition and quality of life at an acceptable level of cost and resource use and without increasing the burden of caregivers. Methods and Design This randomised controlled trial will be performed across two sites, a 500 bed acute hospital in Adelaide, South Australia and a 250 bed acute hospital in Sydney, New South Wales. Four hundred and sixty community-dwelling older adults aged > 70 will be recruited after suffering a proximal femoral fracture and followed into the community over a 12-month period. Participants allocated to the intervention group will receive a six month individualised care plan combining resistance training and nutrition therapy commencing within 14 days post-surgery. Outcomes will be assessed by an individual masked to treatment allocation at six and 12 months. To determine differences between the groups at the primary end-point (six months, ANCOVA or logistic regression will be used with models adjusted according to potential confounders. Discussion The INTERACTIVE trial is among the first to combine nutrition and exercise therapy as an early intervention to address the serious consequence of rapid deconditioning

  13. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies

    Directory of Open Access Journals (Sweden)

    Francis David

    2006-04-01

    Full Text Available Abstract Background A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC and the Health Technology Assessment (HTA Programme. Methods The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate. Results Less than a third (31% of the trials achieved their original recruitment target and half (53% were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41% trials and early recruitment problems were identified in 77 (63% trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed. Conclusion Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds. While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.

  14. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

    LENUS (Irish Health Repository)

    French, Helen P

    2009-01-01

    Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy.

  15. Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gregson Barbara A

    2012-10-01

    Full Text Available Abstract Background Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH; subdural (SDH; and intraparenchymal (TICH. Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial, but none so far of surgery for TICH. Methods/Design The UK National Institutes of Health Research has funded STITCH(Trauma to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial. Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise. Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury. Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to

  16. 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

  17. PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial.

    Science.gov (United States)

    Kilby, Mark; Khan, Khalid; Morris, Katie; Daniels, Jane; Gray, Richard; Magill, Laura; Martin, Bill; Thompson, Peter; Alfirevic, Zarko; Kenny, Simon; Bower, Sarah; Sturgiss, Stephen; Anumba, Dilly; Mason, Gerald; Tydeman, Graham; Soothill, Peter; Brackley, Karen; Loughna, Pamela; Cameron, Alan; Kumar, Sailesh; Bullen, Phil

    2007-07-01

    The primary objective is to determine whether intrauterine vesicoamniotic shunting for fetal bladder outflow obstruction, compared with conservative, noninterventional care, improves prenatal and perinatal mortality and renal function. The secondary objectives are to determine if shunting for fetal bladder outflow obstruction improves perinatal morbidity, to determine if improvement in outcomes is related to prognostic assessment at diagnosis and, if possible, derive a prognostic risk index and to determine the safety and long-term efficacy of shunting. A multicentre randomised controlled trial (RCT). Fetal medicine units. Pregnant women with singleton, male fetus with isolated lower urinary tract obstruction (LUTO). Following ultrasound diagnosis of LUTO in a male fetus and exclusion of other structural and chromosomal anomalies, participation in the trial will be discussed with the mother and written information given. Consent for participation in the trial will be taken and the mother randomised via the internet to either insertion of a vesicoamniotic shunt or expectant management. During pregnancy, both groups will be followed with regular ultrasound scans looking at viability, renal measurements and amniotic fluid volume. Following delivery, babies will be followed up by paediatric nephrologists/urologists at 4-6 weeks, 12 months and 3 and 5 years to assess renal function via serum creatinine, renal ultrasound and need for dialysis/transplant. The main outcome measures will be perinatal mortality rates and renal function at 4-6 weeks and 12 months measured via serum creatinine, renal ultrasound and need for dialysis/transplant. Wellbeing of Women. ESTIMATED COMPLETION DATE: September 2010. TRIAL ALGORITHM: [flowchart: see text].

  18. Effect of Playful Balancing Training - A Pilot Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

    We used the modular playware in the form of modular interactive tiles for playful training of community-dwelling elderly with balancing problem. During short-term play on the modular interactive tiles, the elderly were playing physical, interactive games that were challenging their dynamic balance......, agility, endurance, and sensor-motoric reaction. A population of 12 elderly (average age: 79) with balancing problems (DGI average score: 18.7) was randomly assigned to control group or tiles training group, and tested before and after intervention. The tiles training group had statistical significant...... increase in balancing performance (DGI score: 21.3) after short-term playful training with the modular interactive tiles, whereas the control group remained with a score indicating balancing problems and risk of falling (DGI score: 16.6). The small pilot randomized controlled trial suggests...

  19. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    Directory of Open Access Journals (Sweden)

    Chhangur Rabia R

    2012-10-01

    Full Text Available Abstract Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes. However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-environment interactions to obtain more insight into a moderating effects of polymorphisms on the link between parenting and child behavior, and b behavioral mechanisms that underlie these gene-(gene-environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training. In a screening, families with children aged 4–8 who show mild to (subclinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest, after 6 months (i.e., posttest, and after 10 months (i.e., follow-up. Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and

  20. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  1. Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol.

    Science.gov (United States)

    Vleet, Thomas Van; DeGutis, Joseph; Dabit, Sawsan; Chiu, Christopher

    2014-02-07

    Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care. While previous interventions for spatial neglect have targeted patients' overt spatial deficits (e.g., reduced contralesional visual scanning), far fewer have directly targeted patients' non-spatial deficits (e.g., sustained attention deficits). Considering that non-spatial deficits have shown to be highly predictive of long-term disability, we developed a novel computer based training program that targets both sustained (tonic) and moment-to-moment (phasic) aspects of non-spatial attention (Tonic and Phasic Alertness Training, TAPAT). Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients. The purpose of the current trial (referred to as the REmediation of SPatial Neglect or RESPONSE trial) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes. We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 114 patients with spatial neglect. Patients will either perform, at their home, the experimental TAPAT training program or an active control computer games condition for thirty minutes/day, five days a week, over three months. Patients will be assessed on a battery of cognitive and functional outcomes on three occasions: a) immediately before training, b) within forty-eight hours post completion of total training, and c) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects. The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in neglect, employs highly sensitive computer-based assessments of cognition as well as

  2. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

    Science.gov (United States)

    Haverkamp, Leonie; Brenkman, Hylke J F; Seesing, Maarten F J; Gisbertz, Suzanne S; van Berge Henegouwen, Mark I; Luyer, Misha D P; Nieuwenhuijzen, Grard A P; Wijnhoven, Bas P L; van Lanschot, Jan J B; de Steur, Wobbe O; Hartgrink, Henk H; Stoot, Jan H M B; Hulsewé, Karel W E; Spillenaar Bilgen, Ernst J; Rütter, Jeroen E; Kouwenhoven, Ewout A; van Det, Marc J; van der Peet, Donald L; Daams, Freek; Draaisma, Werner A; Broeders, Ivo A M J; van Stel, Henk F; Lacle, Miangela M; Ruurda, Jelle P; van Hillegersberg, Richard

    2015-07-29

    For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5

  3. Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme

    Directory of Open Access Journals (Sweden)

    Raftery James

    2011-05-01

    Full Text Available Abstract Background Previous research reviewed treatment success and whether the collective uncertainty principle is met in RCTs in the US National Cancer Institute portfolio. This paper classifies clinical trials funded by the UK HTA programme by results using the method applied to the US Cancer Institute trials, and compares the two portfolios. Methods Data on all completed randomised controlled trials funded by the HTA programme 1993-2008 were extracted. Each trial's primary results was classified into six categories; 1 statistically significant in favour of the new treatment, 2 statistically significant in favour of the control treatment 3 true negative, 4 truly inconclusive, 5 inconclusive in favour of new treatment or 6 inconclusive in favour of control treatment. Trials were classified by comparing the 95% confidence interval for the difference in primary outcome to the difference specified in the sample size calculation. The results were compared with Djulbegovic's analysis of NCI trials. Results Data from 51 superiority trials were included, involving over 48,000 participants and a range of diseases and interventions. 85 primary comparisons were available because some trials had more than two randomised arms or had several primary outcomes. The new treatment had superior results (whether significant or not in 61% of the comparisons (52/85 95% CI 49.9% to 71.6%. The results were conclusive in 46% of the comparisons (19% statistically significant in favour of the new treatment, 5% statistically significant in favour of the control and 22% true negative. The results were classified as truly inconclusive (i.e. failed to answer the question asked for 24% of comparisons (20/85. HTA trials included fewer truly inconclusive and statistically significant results and more results rated as true negative than NCI trials. Conclusions The pattern of results in HTA trials is similar to that of the National Cancer Institute portfolio. Differences that

  4. A Randomized Controlled Trial of Caries Prevention in Dental Practice.

    Science.gov (United States)

    Tickle, M; O'Neill, C; Donaldson, M; Birch, S; Noble, S; Killough, S; Murphy, L; Greer, M; Brodison, J; Verghis, R; Worthington, H V

    2017-07-01

    We conducted a parallel group randomized controlled trial of children initially aged 2 to 3 y who were caries free, to prevent the children becoming caries active over the subsequent 36 mo. The setting was 22 dental practices in Northern Ireland, and children were randomly assigned by a clinical trials unit (CTU) (using computer-generated random numbers, with allocation concealed from the dental practice until each child was recruited) to the intervention (22,600-ppm fluoride varnish, toothbrush, 50-mL tube of 1,450 ppm fluoride toothpaste, and standardized, evidence-based prevention advice) or advice-only control at 6-monthly intervals. The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were number of decayed, missing, or filled teeth (dmfs) in caries-active children, number of episodes of pain, and number of extracted teeth. Adverse reactions were recorded. Calibrated external examiners, blinded to the child's study group, assessed the status of the children at baseline and after 3 y. In total, 1,248 children (624 randomized to each group) were recruited, and 1,096 (549 intervention, 547 control) were included in the final analyses. Eighty-seven percent of intervention and 86% of control children attended every 6-mo visit ( P = 0.77). A total of 187 (34%) in the intervention group converted to caries active compared to 213 (39%) in the control group (odds ratio, 0.81; 95% confidence interval, 0.64-1.04; P = 0.11). Mean dmfs of those with caries in the intervention group was 7.2 compared to 9.6 in the control group ( P = 0.007). There was no significant difference in the number of episodes of pain between groups ( P = 0.81) or in the number of teeth extracted in caries-active children ( P = 0.95). Ten children in the intervention group had adverse reactions of a minor nature. This well-conducted trial failed to demonstrate that the intervention kept children caries free, but there was evidence that once

  5. Non-random structures in universal compression and the Fermi paradox

    Science.gov (United States)

    Gurzadyan, A. V.; Allahverdyan, A. E.

    2016-02-01

    We study the hypothesis of information panspermia assigned recently among possible solutions of the Fermi paradox ("where are the aliens?"). It suggests that the expenses of alien signaling can be significantly reduced, if their messages contained compressed information. To this end we consider universal compression and decoding mechanisms ( e.g. the Lempel-Ziv-Welch algorithm) that can reveal non-random structures in compressed bit strings. The efficiency of the Kolmogorov stochasticity parameter for detection of non-randomness is illustrated, along with the Zipf's law. The universality of these methods, i.e. independence from data details, can be principal in searching for intelligent messages.

  6. Non-random structures in universal compression and the Fermi paradox

    CERN Document Server

    Gurzadyan, A V

    2016-01-01

    We study the hypothesis of information panspermia assigned recently among possible solutions of the Fermi paradox ("where are the aliens?"). It suggests that the expenses of alien signaling can be significantly reduced, if their messages contain compressed information. To this end we consider universal compression and decoding mechanisms (e.g. the Lempel-Ziv-Welch algorithm) that can reveal non-random structures in compressed bit strings. The efficiency of Kolmogorov stochasticity parameter for detection of non-randomness is illustrated, along with the Zipf's law. The universality of these methods, i.e. independence on data details, can be principal in searching for intelligent messages.

  7. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial

    Science.gov (United States)

    Van Sciver, Angela; Mahnken, Jonathan D.; Honea, Robyn A.; Brooks, William M.; Billinger, Sandra A.; Swerdlow, Russell H.; Burns, Jeffrey M.

    2017-01-01

    Background There is increasing interest in the role of physical exercise as a therapeutic strategy for individuals with Alzheimer’s disease (AD). We assessed the effect of 26 weeks (6 months) of a supervised aerobic exercise program on memory, executive function, functional ability and depression in early AD. Methods and findings This study was a 26-week randomized controlled trial comparing the effects of 150 minutes per week of aerobic exercise vs. non-aerobic stretching and toning control intervention in individuals with early AD. A total of 76 well-characterized older adults with probable AD (mean age 72.9 [7.7]) were enrolled and 68 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. Neuropsychological tests and surveys were conducted at baseline,13, and 26 weeks to assess memory and executive function composite scores, functional ability (Disability Assessment for Dementia), and depressive symptoms (Cornell Scale for Depression in Dementia). Cardiorespiratory fitness testing and brain MRI was performed at baseline and 26 weeks. Aerobic exercise was associated with a modest gain in functional ability (Disability Assessment for Dementia) compared to individuals in the ST group (X2 = 8.2, p = 0.02). There was no clear effect of intervention on other primary outcome measures of Memory, Executive Function, or depressive symptoms. However, secondary analyses revealed that change in cardiorespiratory fitness was positively correlated with change in memory performance and bilateral hippocampal volume. Conclusions Aerobic exercise in early AD is associated with benefits in functional ability. Exercise-related gains in cardiorespiratory fitness were associated with improved memory performance and reduced hippocampal atrophy, suggesting cardiorespiratory fitness gains may be important in driving brain benefits. Trial registration ClinicalTrials.gov NCT01128361 PMID:28187125

  8. Statistical issues in randomised controlled trials: a narrative synthesis

    Directory of Open Access Journals (Sweden)

    Bolaji Emmanuel Egbewale

    2015-05-01

    Full Text Available Randomised controlled trials (RCT s are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCT s to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s and the outcome variable is more in tandem with statistical principle(s than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-to-treat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCT s are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.

  9. Statistical issues in randomised controlled trials: a narrative synthesis

    Institute of Scientific and Technical Information of China (English)

    Bolaji; Emmanuel; Egbewale

    2015-01-01

    Randomised controlled trials(RCTs) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCTs to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s) should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s) and the outcome variable is more in tandem with statistical principle(s) than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-totreat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCTs are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.

  10. Acupuncture to improve live birth rates for women undergoing in vitro fertilization: a protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Smith Caroline A

    2012-05-01

    Full Text Available Abstract Background IVF is a costly treatment option for women, their partners, and the public. Therefore new therapies that improve reproductive and health outcomes are highly desirable. There is a growing body of research evaluating the effect of acupuncture administered during IVF, and specifically on the day of embryo transfer (ET. Many trials are heterogeneous and results inconsistent. There remains insufficient evidence to determine if acupuncture can enhance live birth rates when used as an adjunct to IVF treatment. The study will determine the clinical effectiveness of acupuncture with improving the proportion of women undergoing IVF having live births. Other objectives include: determination of the cost effectiveness of IVF with acupuncture; and examination of the personal and social context of acupuncture in IVF patients, and examining the reasons why the acupuncture may or may not have worked. Methods We will conduct a randomized controlled trial of acupuncture compared to placebo acupuncture. Inclusion criteria include: women aged less than 43 years; undergoing a fresh IVF or ICSI cycle; and restricted to women with the potential for a lower live birth rate defined as two or more previous unsuccessful ETs; and unsuccessful clinical pregnancies of quality embryos deemed by the embryologist to have been suitable for freezing by standard criteria. Women will be randomized to acupuncture or placebo acupuncture. Treatment is administered on days 6 to 8 of the stimulated cycle and two treatments on the day of ET. A non-randomized cohort of women not using acupuncture will be recruited to the study. The primary study outcome is the proportion of women reporting a live birth. Secondary outcomes include the proportion of women reporting a clinical pregnancy miscarriage prior to 12 weeks, quality of life, and self-efficacy. The sample size of the study is 1,168 women, with the aim of detecting a 7% difference in live births between groups (P

  11. Cardiopulmonary resuscitation support application on a smartphone - randomized controlled trial.

    Science.gov (United States)

    Sakai, Tomohiko; Kitamura, Tetsuhisa; Nishiyama, Chika; Murakami, Yukiko; Ando, Masahiko; Kawamura, Takashi; Tasaki, Osamu; Kuwagata, Yasuyuki; Shimazu, Takeshi; Iwami, Taku

    2015-01-01

    This simulation trial aimed to compare the quality of cardiopulmonary resuscitation (CPR) with and without the newly-developed CPR support application on smartphones. In this trial, participants were randomly assigned to either the CPR support application group or the control group, stratified by sex and previous CPR training. Participants' CPR skills were evaluated by a 2-min case-based scenario test using the Leardal Resusci Anne PC Skill reporting Manikin System(®). The outcome measures were the proportion of chest compressions performed in each group and the number of total chest compressions and appropriate chest compressions performed during the 2-min test period. A total of 84 participants were enrolled and completed the protocol. All participants in the CPR support application group performed chest compressions, compared with only 31 (75.6%) in the control group (Psmartphones contributed to increasing the implementation rate and the number of total chest compressions performed and may assist in improving the survival rate for out-of-hospital cardiac arrests (UMIN000004740).

  12. Sleep disorders in patients with depression or schizophrenia: A randomized controlled trial using acupuncture treatment

    NARCIS (Netherlands)

    Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van

    2016-01-01

    Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40

  13. Cognitive Stimulation in Patients with Dementia: Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Daniela Mapelli

    2013-08-01

    Full Text Available Background/Aims: This study explores the effective outcomes of a structured cognitive stimulation treatment to improve cognition and behavioral symptoms in people with dementia (PWDs, using a randomized controlled clinical trial. Methods: Thirty PWDs were divided into three groups: experimental (treated with cognitive stimulation, placebo (treated with occupational therapy, and control (continuing with the usual activities of the nursing home. Assessment, at baseline and after a period of 8 weeks, was performed using the Clinical Dementia Rating Scale, activities of daily living, Mini-Mental State Examination, Esame Neuropsicologico Breve 2, Geriatric Depression Scale and Behavioral Pathology in Alzheimer's Disease Scale. Results: Only the experimental group improved its performance in cognitive tests (p Conclusions: The results suggest that a cognitive stimulation treatment for PWDs would improve not only their cognition, but also behavioral symptoms.

  14. A control clinicial trial of a new anxiolytic 'clobazam'.

    Science.gov (United States)

    Singh, G; Kumar, V; Kapur, R

    1984-04-01

    Clobazam as a twice-a-day dosage (10 mg-20 mg) regimen and Diazepam in a thrice-a-day schedule (5 mg-5 mg-5 mg) were both effective in controlling moderate to severe anxiety neurosis. 83 patients were studied in a controlled, randomised, double-blind trial. Patients received active drug for the first six weeks and placebo for the next two weeks. Weekly evaluation was performed clinically for anxiolytic effect as well as effect on motor coordination studied on the Pursuit Rotor. Clobazam did not significantly differ from Diazepam in the dosage schedules studied. At the end of the two-week placebo treatment period, patients on Clobazam showed more improvement. Motor coordination was not impaired in both treatment groups. Clobazam treated patients had better motor performance at the end of the 14-day post-treatment placebo period. Side effects were reported with equal frequency in both the populations.

  15. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  16. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

    2015-01-01

    Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

  17. Randomized Controlled Trial of Primary Care Pediatric Parenting Programs

    Science.gov (United States)

    Mendelsohn, Alan L.; Dreyer, Benard P.; Brockmeyer, Carolyn A.; Berkule-Silberman, Samantha B.; Huberman, Harris S.; Tomopoulos, Suzy

    2011-01-01

    Objectives To determine whether pediatric primary care–based programs to enhance parenting and early child development reduce media exposure and whether enhanced parenting mediates the effects. Design Randomized controlled trial. Setting Urban public hospital pediatric primary care clinic. Participants A total of 410 mother-newborn dyads enrolled after childbirth. Interventions Patients were randomly assigned to 1 of 2 interventions, the Video Interaction Project (VIP) and Building Blocks (BB) interventions, or to a control group. The VIP intervention comprised 1-on-1 sessions with a child development specialist who facilitated interactions in play and shared reading through review of videotapes made of the parent and child on primary care visit days; learning materials and parenting pamphlets were also provided. The BB intervention mailed parenting materials, including age-specific newsletters suggesting activities to facilitate interactions, learning materials, and parent-completed developmental questionnaires (Ages and Stages questionnaires). Outcome Measures Electronic media exposure in the home using a 24-hour recall diary. Results The mean (SD) exposure at 6 months was 146.5 (125.0) min/d. Exposure to VIP was associated with reduced total duration of media exposure compared with the BB and control groups (mean [SD] min/d for VIP, 131.6 [118.7]; BB, 151.2 [116.7]; control, 155.4 [138.7]; P=.009). Enhanced parent-child interactions were found to partially mediate relations between VIP and media exposure for families with a ninth grade or higher literacy level (Sobel statistic=2.49; P=.01). Conclusion Pediatric primary care may represent an important venue for addressing the public health problem of media exposure in young children at a population level. Trial Registration clinicaltrials.gov Identifier: NCT00212576 PMID:21199979

  18. Discovering non-random segregation of sister chromatids: The naïve treatment of a premature discovery

    Directory of Open Access Journals (Sweden)

    Karl G. Lark

    2013-02-01

    Full Text Available The discovery of non-random chromosome segregation is discussed from the perspective of what was known in1965 and1966. The distinction between daughter, parent or grandparent strands of DNA was developed in a bacterial system and led to the discovery that multiple copies of DNA elements of bacteria are not distributed randomly with respect to the age of the template strand. Experiments with higher eukaryotic cells demonstrated that during mitosis Mendel’s laws were violated; and the initial serendipitous choice of eukaryotic cell system led to the striking example of non-random segregation of parent and grand-parent DNA template strands in primary cultures of cells derived from mouse embryos. Attempts to extrapolate these findings to established TC lines demonstrated that the property could be lost. Experiments using plant root tips demonstrated that the phenomenon exists in plants and that it was, at some level, under genetic control. Despite publication in major journals and symposia (Lark et al. (1966a; Lark (1967a; 1967b; 1969, 1969a; 1969b the potential implications of these findings were ignored for several decades. Here we explore possible reasons for the pre-maturity (Stent, 1972 of this discovery.

  19. Pressure ulcers: effectiveness of risk-assessment tools. A randomised controlled trial (the ULCER trial).

    Science.gov (United States)

    Webster, Joan; Coleman, Kerrie; Mudge, Alison; Marquart, Louise; Gardner, Glenn; Stankiewicz, Monica; Kirby, Julie; Vellacott, Catherine; Horton-Breshears, Margaret; McClymont, Alice

    2011-04-01

    To evaluate the effectiveness of two pressure-ulcer screening tools against clinical judgement in preventing pressure ulcers. A single blind randomised controlled trial. A large metropolitan tertiary hospital. 1231 patients admitted to internal medicine or oncology wards. Patients were excluded if their hospital stay was expected to be 2 days or less. Participants allocated to either a Waterlow (n=410) or Ramstadius (n=411) screening tool group or to a clinical judgement group (n=410) where no formal risk screening instrument was used. Incidence of hospital acquired pressure ulcers ascertained by regular direct observation. Use of any devices for the prevention of pressure ulcers, documentation of a pressure plan and any dietetic or specialist skin integrity review were recorded. On admission, 71 (5.8%) patients had an existing pressure ulcer. The incidence of hospital-acquired pressure ulcers was similar between groups (clinical judgement 28/410 (6.8%); Waterlow 31/411 (7.5%); Ramstadius 22/410 (5.4%), p=0.44). Significant associations with pressure injury in regression modelling included requiring a dietetic referral, being admitted from a location other than home and age over 65 years. The authors found no evidence to show that two common pressure-ulcer risk-assessment tools are superior to clinical judgement to prevent pressure injury. Resources associated with use of these tools might be better spent on careful daily skin inspection and improving management targetted at specific risks. The trial was registered with the Australian and New Zealand Clinicat Trials Registry (ACTRN 12608000541303).

  20. Guidelines for controlled trials of prophylactic treatment of chronic migraine in adults

    DEFF Research Database (Denmark)

    Silberstein, S.; Tfelt-Hansen, P.; Dodick, D.W.

    2008-01-01

    In 1991 the Clinical Trials Subcommittee of the International Headache Society (IHS) developed and published its first edition of the Guidelines on controlled trials of drugs in episodic migraine because only quality trials can form the basis for international collaboration on drug therapy...... to assist in the design of well-controlled clinical trials of chronic migraine in adults, and do not apply to studies in children or adolescents Udgivelsesdato: 2008/5...

  1. Testing the activitystat hypothesis: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Gomersall Sjaan

    2012-10-01

    Full Text Available Abstract Background The activitystat hypothesis proposes that when physical activity or energy expenditure is increased or decreased in one domain, there will be a compensatory change in another domain to maintain an overall, stable level of physical activity or energy expenditure. To date, there has been no experimental study primarily designed to test the activitystat hypothesis in adults. The aim of this trial is to determine the effect of two different imposed exercise loads on total daily energy expenditure and physical activity levels. Methods This study will be a randomised, multi-arm, parallel controlled trial. Insufficiently active adults (as determined by the Active Australia survey aged 18–60 years old will be recruited for this study (n=146. Participants must also satisfy the Sports Medicine Australia Pre-Exercise Screening System and must weigh less than 150 kg. Participants will be randomly assigned to one of three groups using a computer-generated allocation sequence. Participants in the Moderate exercise group will receive an additional 150 minutes of moderate to vigorous physical activity per week for six weeks, and those in the Extensive exercise group will receive an additional 300 minutes of moderate to vigorous physical activity per week for six weeks. Exercise targets will be accumulated through both group and individual exercise sessions monitored by heart rate telemetry. Control participants will not be given any instructions regarding lifestyle. The primary outcome measures are activity energy expenditure (doubly labeled water and physical activity (accelerometry. Secondary measures will include resting metabolic rate via indirect calorimetry, use of time, maximal oxygen consumption and several anthropometric and physiological measures. Outcome measures will be conducted at baseline (zero weeks, mid- and end-intervention (three and six weeks with three (12 weeks and six month (24 week follow-up. All assessors will be

  2. Dilatation or no dilatation of the cervix during cesarean section (Dondi Trial): a randomized controlled trial.

    Science.gov (United States)

    Kirscht, Jade; Weiss, Christel; Nickol, Jana; Berlit, Sebastian; Tuschy, Benjamin; Hoch, Benjamin; Trebin, Amelie-Verena; Große-Steffen, Thomas; Sütterlin, Marc; Kehl, Sven

    2017-01-01

    To assess the effects of mechanical dilatation of the cervix during cesarean section on postoperative morbidity. A total of 447 women with elective cesarean section were included in the Dondi trial (Dilatation or no dilatation of the cervix during cesarean section). The primary outcome measure of this randomized controlled trial was postpartum hemorrhage (PPH) within 6 weeks. Infectious morbidity (puerperal fever, endometritis, wound infection, and urinary tract infection), blood loss (need for blood transfusion or change in hemoglobin levels), and operating time were also evaluated. The rate of PPH within 6 weeks was not different between the two groups [dilatation group: 5 (2.4 %), no dilatation group: 3 (1.2 %), p = 0.479]. Infectious morbidity, blood loss, and operating time were not diverse as well. The only significant difference between the two groups was the rate of retained products of conception with fewer cases after cervical dilatation (0 versus 6.2 %, p cesarean section compared with no dilatation of the cervix did not influence the risk of postpartum hemorrhage. However, there were fewer cases with retained products of conception after dilatation.

  3. Non-random assembly of bacterioplankton communities in the subtropical North Pacific Ocean

    Directory of Open Access Journals (Sweden)

    Alexander eEiler

    2011-07-01

    Full Text Available The exploration of bacterial diversity in the global ocean has revealed new taxa and previously unrecognized metabolic potential; however, our understanding of what regulates this diversity is limited. Using terminal restriction fragment length polymorphism (T-RFLP data of bacterial small-subunit ribosomal RNA genes we show that, independent of depth and time, a large fraction of bacterioplankton co-occurrence patterns are non-random in the oligotrophic North Pacific subtropical gyre (NPSG. Pair-wise correlations of all identified operational taxonomic units (OTUs revealed a high degree of significance, with 6.6% of the pair-wise co-occurrences being negatively correlated and 20.7% of them being positive. The most abundant OTUs, putatively identified as Prochlorococcus, SAR11 and SAR116 bacteria, were among the most correlated OTUs. As expected, bacterial community composition lacked statistically significant patterns of seasonality in the mostly stratified water column except in a few depth horizons of the sunlit surface waters, with higher frequency variations in community structure apparently related to populations associated with the deep chlorophyll maximum. Communities were structured vertically, with a succession from euphotic, mesopelagic, and bathylopelagic populations. Permutation based statistical analyses of T-RFLP data and their corresponding metadata revealed a broad range of putative environmental drivers controlling bacterioplankton community composition in the NPSG, including concentrations of inorganic nutrients and phytoplankton pigment. Together our results suggest that deterministic forces, such as environmental filtering and interactions among taxa, determine bacterioplankton community patterns, and consequently affect ecosystem functions in the NPSG.

  4. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

    DEFF Research Database (Denmark)

    Gluud, Christian; Nikolova, Dimitrinka

    2007-01-01

    The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.......The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study....

  5. Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Hideyuki Sawada

    Full Text Available BACKGROUND: Dyskinesias are some of the major motor complications that impair quality of life for patients with Parkinson's disease. The purpose of the present study was to investigate the efficacy of amantadine in Parkinson's disease patients suffering from dyskinesias. METHODS: In this multi-center, double-blind, randomized, placebo-controlled, cross-over trial, 36 patients with Parkinson's disease and dyskinesias were randomized, and 62 interventions, which included amantadine (300 mg/day or placebo treatment for 27 days, were analyzed. At 15 days after washout, the treatments were crossed over. The primary outcome measure was the changes in the Rush Dyskinesia Rating Scale (RDRS during each treatment period. The secondary outcome measures were changes in the Unified Parkinson's Disease Rating Scale part IVa (UPDRS-IVa, dyskinesias, part IVb (motor fluctuations, and part III (motor function. RESULTS: RDRS improved in 64% and 16% of patients treated with amantadine or placebo, respectively, with significant differences between treatments. The adjusted odds-ratio for improvement by amantadine was 6.7 (95% confidence interval, 1.4 to 31.5. UPDRS-IVa was improved to a significantly greater degree in amantadine-treated patients [mean (SD of 1.83 (1.56] compared with placebo-treated patients [0.03 (1.51]. However, there were no significant effects on UPDRS-IVb or III scores. CONCLUSIONS: Results from the present study demonstrated that amantadine exhibited efficacious effects against dyskinesias in 60-70% of patients. TRIAL REGISTRATION: UMIN Clinical Trial Registry UMIN000000780.

  6. Acupuncture for dry eye: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kim Ae-Ran

    2009-12-01

    Full Text Available Abstract Background Dry eye is usually managed by conventional medical interventions such as artificial tears, anti-inflammatory drugs and surgical treatment. However, since dry eye is one of the most frequent ophthalmologic disorders, safer and more effective methods for its treatment are necessary, especially for vulnerable patients. Acupuncture has been widely used to treat patients with dry eye. Our aim is to evaluate the effectiveness and safety of acupuncture for this condition. Methods/Design A randomised, patient-assessor blinded, sham (non-acupuncture point, shallow acupuncture controlled study was established. Participants allocated to verum acupuncture and sham acupuncture groups will be treated three times weekly for three weeks for a total of nine sessions per participant. Seventeen points (GV23; bilateral BL2, GB4, TE23, Ex1 (Taiyang, ST1 and GB20; and left SP3, LU9, LU10 and HT8 for men, right for women have been selected for the verum acupuncture; for the sham acupuncture, points have been selected that do not coincide with a classical acupuncture point and that are located close to the verum points, except in the case of the rim of the eye. Ocular surface disease index, tear film breakup time, the Schirmer I test, medication quantification scale and general assessment of improvement will be used as outcome variables for evaluating the effectiveness of acupuncture. Safety will also be assessed at every visit. Primary and secondary outcomes will be assessed four weeks after screening. All statistical analyses will be performed using analysis of covariance. Discussion The results of this trial will be used as a basis for clarifying the efficacy of acupuncture for dry eye. Trial registration ClinicalTrials.gov NCT00969280.

  7. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    Science.gov (United States)

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  8. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    Science.gov (United States)

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  9. What device should be used for telementoring? Randomized controlled trial.

    Science.gov (United States)

    Budrionis, Andrius; Hartvigsen, Gunnar; Lindsetmo, Rolv-Ole; Bellika, Johan Gustav

    2015-09-01

    The paper analyzes behavioral patterns of mentors while using different mentoring devices to demonstrate the feasibility of multi-platform mentoring. The fundamental differences of devices supporting telementoring create threats for the perception and interpretation of the transmitted video, highlighting the necessity of exploring hardware usability aspects in a safety critical surgical mentoring scenario. Three types of devices, based on the screen size, formed the arms for the randomized controlled trial. Streaming video recordings of a laparoscopic procedure to the mentors imitated the mentoring scenario. User preferences and response times were recorded while participating in a session performed on all devices. Median response to a mentoring request times were similar for mobile platforms; expected durations were considerably longer for stationary computer. Ability to perceive and identify anatomical structures was insignificantly lower on small sized devices. Stationary and tablet platforms were nearly equally preferred by the most of participants as default telementoring hardware. As a side effect, incompatibility of daily duties of the surgeons in the hospital and telementoring responsibilities while implementing systems locally was identified. Scaling up the use of the service in combination with the organizational changes of clinical staff looks like a promising solution. The trial demonstrated the feasibility of using all three types of devices for the purpose of mentoring, allowing users to choose the preferred platform. The paper provided initial results on the quality assurance of telementoring systems imposed by the regulatory documents. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  10. Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial.

    Directory of Open Access Journals (Sweden)

    Kirsti Krohn Garnæs

    2016-07-01

    .04. Systolic blood pressure was significantly lower in the exercise group (mean 120.4 mm Hg compared to the control group (mean 128.1 mm Hg, with a mean difference of -7.73 mm Hg (95% CI -13.23, -2.22; p = 0.006. No significant between-group differences were seen in diastolic blood pressure, blood measurements, skinfold thickness, or body composition in late pregnancy. In per protocol analyses, late pregnancy systolic blood pressure was 115.7 (95% CI 110.0, 121.5 mm Hg in the exercise group (significant between-group difference, p = 0.001, and diastolic blood pressure was 75.1 (95% CI 71.6, 78.7 mm Hg (significant between-group difference, p = 0.02. We had planned to recruit 150 women into the trial; hence, under-recruitment represents a major limitation of our results. Another limitation to our study was the low adherence to the exercise program, with only 50% of the women included in the intention-to-treat analysis adhering as described in the study protocol.In this trial we did not observe a reduction in GWG among overweight/obese women who received a supervised exercise training program during their pregnancy. The incidence of GDM in late pregnancy seemed to be lower in the women randomized to exercise training than in the women receiving standard maternity care only. Systolic blood pressure in late pregnancy was also apparently lower in the exercise group than in the control group. These results indicate that supervised exercise training might be beneficial as a part of standard pregnancy care for overweight/obese women.ClinicalTrials.gov NCT01243554.

  11. Stress debriefing after childbirth: a randomised controlled trial.

    Science.gov (United States)

    Priest, Susan R; Henderson, Jenni; Evans, Sharon F; Hagan, Ronald

    2003-06-02

    To test whether critical incident stress debriefing after childbirth reduces the incidence of postnatal psychological disorders. Randomised single-blind controlled trial stratified for parity and delivery mode. Two large maternity hospitals in Perth. 1745 women who delivered healthy term infants between April 1996 and December 1997 (875 allocated to intervention and 870 to control group). An individual, standardised debriefing session based on the principles of critical incident stress debriefing carried out within 72 hours of delivery. Diagnosis of stress disorders or depression in the 12 months postpartum, using structured psychological interview and criteria of the Diagnostic and statistical manual of mental disorders, 4th edition. Follow-up information was available for 1730 women (99.1%), 482 of whom underwent psychological interview. There were no significant differences between control and intervention groups in scores on Impact of Events or Edinburgh Postnatal Depression Scales at 2, 6 or 12 months postpartum, or in proportions of women who met diagnostic criteria for a stress disorder (intervention, 0.6% v control, 0.8%; P = 0.58) or major or minor depression (intervention, 17.8% v control, 18.2%; relative risk [95% CI], 0.99 [0.87-1.11]) during the postpartum year. Nor were there differences in median time to onset of depression (intervention, 6 [interquartile range, 4-9] weeks v control, 4 [3-8] weeks; P = 0.84), or duration of depression (intervention, 24 [12-46] weeks v control, 22 [10-52] weeks; P = 0.98). There is a high prevalence of depression in women during the first year after childbirth. A session of midwife-led, critical incident stress debriefing was not effective in preventing postnatal psychological disorders, but had no adverse effects.

  12. Exercise and manual physiotherapy arthritis research trial (EMPART: a multicentre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Connell Paul

    2009-01-01

    Full Text Available Abstract Background Osteoarthritis (OA of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. Methods and design An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC, pain severity (numerical rating scale, patient perceived change (7-point Likert scale, quality of life (SF-36, mood (hospital anxiety and depression scale, patient satisfaction, physical activity (IPAQ and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. Discussion This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The

  13. INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST: a randomized controlled trial of percutaneous vertebroplasty

    Directory of Open Access Journals (Sweden)

    Stout Lydia

    2007-12-01

    -primary outcomes are the modified Roland score and pain numerical rating scale at 1 month. Discussion Although extensively utilized throughout North America for palliation of pain, vertebroplasty still has not undergone rigorous study. The study outlined above represents the first randomized, controlled study that can account for a placebo effect in the setting of vertebroplasty. Trial Registration Current Controlled Trials ISRCTN81871888

  14. Clinical review: Strict or loose glycemic control in critically ill patients - implementing best available evidence from randomized controlled trials

    NARCIS (Netherlands)

    Schultz, M.J.; Harmsen, R.E.; Spronk, P.E.

    2010-01-01

    Glycemic control aiming at normoglycemia, frequently referred to as 'strict glycemic control' (SGC), decreased mortality and morbidity of adult critically ill patients in two randomized controlled trials (RCTs). Five successive RCTs, however, failed to show benefit of SGC with one trial even reporti

  15. Effects of the Finnish Alzheimer disease exercise trial (FINALEX): a randomized controlled trial.

    Science.gov (United States)

    Pitkälä, Kaisu H; Pöysti, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo S; Savikko, Niina; Kautiainen, Hannu; Strandberg, Timo E

    2013-05-27

    Few rigorous clinical trials have investigated the effectiveness of exercise on the physical functioning of patients with Alzheimer disease (AD). To investigate the effects of intense and long-term exercise on the physical functioning and mobility of home-dwelling patients with AD and to explore its effects on the use and costs of health and social services. A randomized controlled trial. A total of 210 home-dwelling patients with AD living with their spousal caregiver. The 3 trial arms included (1) group-based exercise (GE; 4-hour sessions with approximately 1-hour training) and (2) tailored home-based exercise (HE; 1-hour training), both twice a week for 1 year, and (3) a control group (CG) receiving the usual community care. The Functional Independence Measure (FIM), the Short Physical Performance Battery, and information on the use and costs of social and health care services. All groups deteriorated in functioning during the year after randomization, but deterioration was significantly faster in the CG than in the HE or GE group at 6 (P = .003) and 12 (P = .015) months. The FIM changes at 12 months were -7.1 (95% CI, -3.7 to -10.5), -10.3 (95% CI, -6.7 to -13.9), and -14.4 (95% CI, -10.9 to -18.0) in the HE group, GE group, and CG, respectively. The HE and GE groups had significantly fewer falls than the CG during the follow-up year. The total costs of health and social services for the HE patient-caregiver dyads (in US dollars per dyad per year) were $25,112 (95% CI, $17,642 to $32,581) (P = .13 for comparison with the CG), $22,066 in the GE group ($15,931 to $28,199; P = .03 vs CG), and $34,121 ($24,559 to $43,681) in the CG. An intensive and long-term exercise program had beneficial effects on the physical functioning of patients with AD without increasing the total costs of health and social services or causing any significant adverse effects. anzctr.org.au Identifier: ACTRN12608000037303.

  16. Reporting of consistency of blood pressure control in randomized controlled trials of antihypertensive drugs: a systematic review of 1372 trial reports.

    Science.gov (United States)

    Fischer, Urs; Webb, Alastair J S; Howard, Sally C; Rothwell, Peter M

    2012-07-01

    Hypertension is a powerful treatable risk factor for stroke. Reports of randomized controlled trials (RCTs) of antihypertensive drugs rightly concentrate on clinical outcomes, but control of blood pressure (BP) during follow-up is also important, particularly given that inconsistent control is associated with a high risk of stroke and that antihypertensive drug classes differ in this regard. We performed a systematic review of reporting of BP control in RCTs of antihypertensive drugs. We searched bibliographic databases (1950-2009) for systematic reviews of RCTs of BP-lowering and identified the main report of all trials. We identified 94 larger trials (>100 participants/arm, >1-year follow-up) and 1278 smaller/shorter trials. Ninety-one (96.8%) larger trials reported some data on mean BP during follow-up, but none reported effects on the consistency of control of BP over time. Although 81 (86.2%) larger trials reported group distribution of BP at baseline (usually SD), only 22 (23.4%) reported such data at any follow-up visit. Eleven (11.7%) larger trials reported group distribution of the change in BP from baseline to follow-up, but 61 (64.9%) reported no data at all on group distribution of BP at follow-up. Thirty-nine (41.5%) trials reported the proportion of patients reaching some BP target during follow-up, but no trial reported data on the consistency of control to target within individuals over time. Similar proportions were observed in the 1278 smaller/short trials. Reporting of BP control is limited in RCTs of BP-lowering drugs. We suggest reporting guidelines.

  17. ROLE OF CELECOXIB IN BENIGN BREAST DISEASE: RANDOMISED CONTROL TRIAL

    Directory of Open Access Journals (Sweden)

    Soumen Das

    2012-06-01

    Full Text Available Benign Breast Disease (BBD, commonest cause of morbidity in females due to breast diseases, still offers therapeutic challenge. Several drug therapies (with Evening Primrose Oil, Danazol etc have been tried, but none made gold standard. Reports on effect of Cox-2 inhibitors are scarce. This randomized control trial aims at determination of effect of Cox- inhibitors (Celecoxib in BBD in comparison to Evening Primrose Oil (EPO . Celecoxib showed better reduction in lump size (in 80% than EPO group (in 50%. Pain reduction was excellent in COX -2 groups as compared to EPO group. Recurrence rate was also lower in Celecoxib group at 10 weeks. Side effects were almost nil in both the groups. Celecoxib is better than EPO in the management of BBD. Short course therapy with COX-2 inhibitors gives good pain relief, greater reduction in lump size, low recurrence with minimum side effects.

  18. Acupressure therapy for morning sickness. A controlled clinical trial.

    Science.gov (United States)

    Hyde, E

    1989-01-01

    A prospective, controlled clinical trial examined the efficacy of acupressure therapy for morning sickness, using a two group, random assignment, crossover design. Subjects in Group 1 (N = 8) used acupressure wristbands for five days, followed by five days without therapy. Subjects in Group 2 (N = 8) had no therapy for five days, followed by five days use of wristbands. The Multiple Affect Adjective Checklist and Sickness Impact Profile were used, and extent of nausea was assessed at baseline, day five, and day ten. Use of acupressure wristbands relieved morning sickness for 12 of 16 subjects (chi 2 = 5.31 with Yates' correction factor, df = 1, p less than .025). Acupressure therapy resulted in statistically significant (p less than .05) reductions in anxiety, depression, behavioral dysfunction, and nausea. Limitations of the study and suggestions for future research are presented.

  19. Acupucture as pain relief during delivery - a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... with the intention-to-treat principle. Results: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin...

  20. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    BACKGROUND: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... with the intention-to-treat principle. RESULTS: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin...

  1. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    , nursing research, nursing, research, challenges, barriers, nurse's role, nurse attitude, attitude of health personnel. Findings: The literature on reported challenges and barriers between 1999 and 2009 showed that the most often experienced problems were (i) sufficient patient recruitment, (ii......Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...

  2. [Critical of the additive model of the randomized controlled trial].

    Science.gov (United States)

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  3. Controlled trial of plasma exchange in treatment of Raynaud's syndrome.

    Science.gov (United States)

    O'Reilly, M J; Talpos, G; Roberts, V C; White, J M; Cotton, L T

    1979-01-01

    Twenty-seven patients with Raynaud's syndrome had their digital vessel patency assessed by Doppler ultrasound after different thermal stresses. Digital vessel patency rates differed significantly after stresses at 15 degrees C and 45 degrees C. In a randomised controlled trial placebo and heparin had no effect either on patients' symptoms or on the patency of their digital vessels. Plasma exchange improved both symptoms and vessel patency rates at 15 degrees C and 21 degrees C. Improvement in seven out of eight of these patients has been maintained for six months. Assessing digital vessel patency by Doppler techniques allow continuous, atraumatic, and safe evaluation of the effects of different methods of treatment on the patency of the digital vessels and has helped to indicate that plasma exchange is a useful adjunct in the management of patients with severe Raynaud's syndrome. PMID:376042

  4. Guidelines for controlled trials of drugs in tension-type headache: second edition.

    Science.gov (United States)

    Bendtsen, L; Bigal, M E; Cerbo, R; Diener, H C; Holroyd, K; Lampl, C; Mitsikostas, D D; Steiner, T J; Tfelt-Hansen, P

    2010-01-01

    The Clinical Trials Subcommittee of the International Headache Society published its first edition of the guidelines on controlled trials of drugs in tension-type headache in 1995. These aimed 'to improve the quality of controlled clinical trials in tension-type headache', because 'good quality controlled trials are the only way to convincingly demonstrate the efficacy of a drug, and form the basis for international agreement on drug therapy'. The Committee published similar guidelines for clinical trials in migraine and cluster headache. Since 1995 several studies on the treatment of episodic and chronic tension-type headache have been published, providing new information on trial methodology for this disorder. Furthermore, the classification of the headaches, including tension-type headache, has been revised. These developments support the need for also revising the guidelines for drug treatments in tension-type headache. These Guidelines are intended to assist in the design of well-controlled clinical trials in tension-type headache.

  5. Cortical atrophy patterns in multiple sclerosis are non-random and clinically relevant.

    Science.gov (United States)

    Steenwijk, Martijn D; Geurts, Jeroen J G; Daams, Marita; Tijms, Betty M; Wink, Alle Meije; Balk, Lisanne J; Tewarie, Prejaas K; Uitdehaag, Bernard M J; Barkhof, Frederik; Vrenken, Hugo; Pouwels, Petra J W

    2016-01-01

    cortical atrophy in multiple sclerosis occurs largely in a non-random manner and develops (at least partly) according to distinct anatomical patterns. In addition, these cortical atrophy patterns showed stronger associations with clinical (especially cognitive) dysfunction than global cortical atrophy.

  6. Multidisciplinary intervention reducing readmissions in medical inpatients: a prospective, non-randomized study

    Directory of Open Access Journals (Sweden)

    Torisson G

    2013-09-01

    Full Text Available Gustav Torisson,1 Lennart Minthon,1 Lars Stavenow,2 Elisabet Londos1 1Clinical Memory Research Unit, Department of Clinical Sciences, Lund University, 2Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden Background: The purpose of this study was to examine whether a multidisciplinary intervention targeting drug-related problems, cognitive impairment, and discharge miscommunication could reduce readmissions in a general hospital population. Methods: This prospective, non-randomized intervention study was carried out at the department of general internal medicine at a tertiary university hospital. Two hundred medical inpatients living in the community and aged over 60 years were included. Ninety-nine patients received interventions and 101 received standard care. Control/intervention allocation was determined by geographic selection. Interventions consisted of a comprehensive medication review, improved discharge planning, post-discharge telephone follow-up, and liaison with the patient's general practitioner. The main outcome measures recorded were readmissions and hospital nights 12 months after discharge. Separate analyses were made for 12-month survivors and from an intention-to-treat perspective. Comparative analyses were made between groups as well as within groups over time. Results: After 12 months, survivors in the control group had 125 readmissions in total, compared with 58 in the intervention group (Mann–Whitney U test, P = 0.02. For hospital nights, the numbers were 1,228 and 492, respectively (P = 0.009. Yearly admissions had increased from the previous year in the control group from 77 to 125 (Wilcoxon signed-rank test, P = 0.002 and decreased from 75 to 58 in the intervention group (P = 0.25. From the intention-to-treat perspective, the same general pattern was observed but was not significant (1,827 versus 1,008 hospital nights, Mann–Whitney test, P = 0.054. Conclusion: A multidisciplinary approach

  7. Acupuncture to improve live birth rates for women undergoing in vitro fertilization: a protocol for a randomized controlled trial.

    Science.gov (United States)

    Smith, Caroline A; de Lacey, Sheryl; Chapman, Michael; Ratcliffe, Julie; Norman, Robert J; Johnson, Neil; Sacks, Gavin; Lyttleton, Jane; Boothroyd, Clare

    2012-05-18

    IVF is a costly treatment option for women, their partners, and the public. Therefore new therapies that improve reproductive and health outcomes are highly desirable. There is a growing body of research evaluating the effect of acupuncture administered during IVF, and specifically on the day of embryo transfer (ET). Many trials are heterogeneous and results inconsistent. There remains insufficient evidence to determine if acupuncture can enhance live birth rates when used as an adjunct to IVF treatment.The study will determine the clinical effectiveness of acupuncture with improving the proportion of women undergoing IVF having live births. Other objectives include: determination of the cost effectiveness of IVF with acupuncture; and examination of the personal and social context of acupuncture in IVF patients, and examining the reasons why the acupuncture may or may not have worked. We will conduct a randomized controlled trial of acupuncture compared to placebo acupuncture.Inclusion criteria include: women aged less than 43 years; undergoing a fresh IVF or ICSI cycle; and restricted to women with the potential for a lower live birth rate defined as two or more previous unsuccessful ETs; and unsuccessful clinical pregnancies of quality embryos deemed by the embryologist to have been suitable for freezing by standard criteria. Women will be randomized to acupuncture or placebo acupuncture. Treatment is administered on days 6 to 8 of the stimulated cycle and two treatments on the day of ET. A non-randomized cohort of women not using acupuncture will be recruited to the study. The primary study outcome is the proportion of women reporting a live birth. Secondary outcomes include the proportion of women reporting a clinical pregnancy miscarriage prior to 12 weeks, quality of life, and self-efficacy. The sample size of the study is 1,168 women, with the aim of detecting a 7% difference in live births between groups (P = 0.05, 80% power). There remains a need for

  8. A controlled trial of the father's role in breastfeeding promotion.

    Science.gov (United States)

    Pisacane, Alfredo; Continisio, Grazia Isabella; Aldinucci, Maria; D'Amora, Stefania; Continisio, Paola

    2005-10-01

    To investigate whether supporting fathers to recognize the relevance of their role in the success of breastfeeding and teaching them how to prevent and to manage the most common lactation problems would result in more women breastfeeding. A controlled trial, in which the participating fathers were allocated in 2-month blocks to a child care training session, was conducted of 280 mothers considering breastfeeding and their 280 partners at a university obstetric department in Naples, Italy. Support and advice about breastfeeding was provided to all of the mothers. Among the fathers of the intervention group, the training session included the management of breastfeeding; among those of the control group, it did not. Primary outcome was the prevalence of full breastfeeding at 6 months. Secondary outcomes were the proportion of women who perceived their milk to be insufficient, who stopped breastfeeding because of problems, and who reported to have received help in breastfeeding management by their partners. The prevalence of full breastfeeding at 6 months was 25% (35 of 140) in the intervention group and 15% (21 of 140) in the control group and that of any breastfeeding at 12 months was 19% (27) and 11% (16), respectively. Perceived milk insufficiency was significantly more frequent among the mothers of the control group (38 [27%] of 140 vs 12 [8.6%] of 140), as well as breastfeeding interruption because of problems with lactation (25 [18%] of 140 vs 6 [4%] of 140). Moreover, significantly more women in the intervention group reported receiving support and relevant help with infant feeding management from their partners (128 [91%] of 140 vs 48 [34%] of 140). Among the women who had reported difficulties with lactation in the intervention and control groups (96 [69%] and 89 [64%], respectively), the prevalence of full breastfeeding at 6 months was 24% and 4.5%, respectively. Teaching fathers how to prevent and to manage the most common lactation difficulties is

  9. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available Background: A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. Methods: In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device. Conclusions: POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  10. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial

    Science.gov (United States)

    Clark, William F; Sontrop, Jessica M; Huang, Shih-Han; Gallo, Kerri; Moist, Louise; House, Andrew A; Weir, Matthew A; Garg, Amit X

    2013-01-01

    Background and objectives Increased water intake may benefit kidney function. Prior to initiating a larger randomised controlled trial (RCT), we examined the safety and feasibility of asking adults with chronic kidney disease (CKD) to increase their water intake. Design, setting, participants and measurements Beginning in October 2012, we randomly assigned 29 adults with stage 3 CKD (estimated glomerular filtration rate (eGFR) 30–60 mL/min/1.73 m2 and albuminuria) to one of the two groups of water intake: hydration (n=18) or standard (n=11). We asked the hydration group to increase their water intake by 1.0–1.5 L/day (in addition to usual intake, depending on sex and weight) for 6 weeks, while the control group carried on with their usual intake. Participants collected a 24 h urine sample at baseline and at 2 and 6 weeks after randomisation. Our primary outcome was the between-group difference in change in 24 h urine volume from baseline to 6 weeks. Results (63%)of participants were men, 81% were Caucasians and the average age was 61 years (SD 14 years). The average baseline eGFR was 40 mL/min/1.73 m2 (SD 11 mL/min/1.73 m2); the median albumin to creatinine ratio was 19 mg/mmol (IQR 6–74 mg/mmol). Between baseline and 6-week follow-up, the hydration group's average 24 h urine volume increased by 0.7 L/day (from 2.3 to 3.0 L/day) and the control group's 24 h urine decreased by 0.3 L/day (from 2.0 to 1.7 L/day; between-group difference in change: 0.9 L/day (95% CI 0.4 to 1.5; p=0.002)). We found no significant changes in urine, serum osmolality or electrolyte concentrations, or eGFR. No serious adverse events or changes in quality of life were reported. Conclusions A pilot RCT indicates adults with stage 3 CKD can successfully and safely increase water intake by up to 0.7 L/day in addition to usual fluid intake. Trial registration Registered with Clinical Trials—government identifier NCT01753466. PMID:24362012

  11. Optimal Macronutrient Content of the Diet for Adolescents With Prediabetes; RESIST a Randomised Control Trial

    National Research Council Canada - National Science Library

    Garnett, Sarah P; Gow, Megan; Ho, Mandy; Baur, Louise A; Noakes, Manny; Woodhead, Helen J; Broderick, Carolyn R; Burrell, Susie; Chisholm, Kerryn; Halim, Jocelyn; De, Sukanya; Steinbeck, Katherine; Srinivasan, Shubha; Ambler, Geoffrey R; Kohn, Michael R; Cowell, Chris T

    2013-01-01

    ...: This study was a randomized controlled trial, known as Researching Effective Strategies to Improve Insulin Sensitivity in Children and Teenagers, in 2 hospitals in Sydney, Australia. Participants...

  12. Handsearching the EMHJ for reports of randomized controlled trials by U.K. Cochrane Centre (Bahrain).

    Science.gov (United States)

    Al Hajeri, A; Al Sayyad, J; Eisinga, A

    2006-01-01

    This study used handsearching to find reports of randomized controlled trials in the Eastern Mediterranean Health Journal (EMHJ). EMBASE and MEDLINE were also searched electronically to identify if the reports found by the handsearch were already included in either of these databases. Nine reports were identified: 7 randomized controlled trials and 2 controlled clinical trials. The added value of the handsearch over EMBASE was 6 additional reports and over MEDLINE was 4. Reports identified were sent to the UK Cochrane Centre for verification and publication in The Cochrane Central Register of Controlled Trials (CENTRAL).

  13. What can qualitative research do for randomised controlled trials? A systematic mapping review

    Science.gov (United States)

    O'Cathain, A; Thomas, K J; Drabble, S J; Rudolph, A; Hewison, J

    2013-01-01

    Objective To develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. Design Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. Data sources MEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. Eligibility criteria Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. Results 296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles 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, process 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 target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. Conclusions A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit

  14. The Norwegian tenecteplase stroke trial (NOR-TEST): Randomised controlled trial of tenecteplase vs. alteplase in acute ischaemic stroke

    OpenAIRE

    2014-01-01

    Background: Alteplase is the only approved thrombolytic agent for acute ischaemic stroke. The overall benefit from alteplase is substantial, but some evidence indicates that alteplase also has negative effects on the ischaemic brain. Tenecteplase may be more effective and less harmfull than alteplase, but large randomised controlled phase 3 trials are lacking. The Norwegian Tenecteplase Stroke Trial (NOR-TEST) aims to compare efficacy and safety of tenecteplase vs. alteplase. Methods/Desig...

  15. The reporting quality of randomized controlled trials in orthodontics.

    Science.gov (United States)

    Lempesi, Evangelia; Koletsi, Despina; Fleming, Padhraig S; Pandis, Nikolaos

    2014-06-01

    Accurate trial reporting facilitates evaluation and better use of study results. The objective of this article is to investigate the quality of reporting of randomized controlled trials (RCTs) in leading orthodontic journals, and to explore potential predictors of improved reporting. The 50 most recent issues of 4 leading orthodontic journals until November 2013 were electronically searched. Reporting quality assessment was conducted using the modified CONSORT statement checklist. The relationship between potential predictors and the modified CONSORT score was assessed using linear regression modeling. 128 RCTs were identified with a mean modified CONSORT score of 68.97% (SD = 11.09). The Journal of Orthodontics (JO) ranked first in terms of completeness of reporting (modified CONSORT score 76.21%, SD = 10.1), followed by American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) (73.05%, SD = 10.1). Journal of publication (AJODO: β = 10.08, 95% CI: 5.78, 14.38; JO: β = 16.82, 95% CI: 11.70, 21.94; EJO: β = 7.21, 95% CI: 2.69, 11.72 compared to Angle), year of publication (β = 0.98, 95% CI: 0.28, 1.67 for each additional year), region of authorship (Europe: β = 5.19, 95% CI: 1.30, 9.09 compared to Asia/other), statistical significance (significant: β = 3.10, 95% CI: 0.11, 6.10 compared to non-significant) and methodologist involvement (involvement: β = 5.60, 95% CI: 1.66, 9.54 compared to non-involvement) were all significant predictors of improved modified CONSORT scores in the multivariable model. Additionally, median overall Jadad score was 2 (IQR = 2) across journals, with JO (median = 3, IQR = 1) and AJODO (median = 3, IQR = 2) presenting the highest score values. The reporting quality of RCTs published in leading orthodontic journals is considered suboptimal in various CONSORT areas. This may have a bearing in trial result interpretation and use in clinical decision making and evidence- based orthodontic treatment interventions. Copyright

  16. Effect of a stroke-specific follow-up care model on the quality of life of stroke patients and caregivers: A controlled trial.

    Science.gov (United States)

    Fens, Manon; van Heugten, Caroline M; Beusmans, George; Metsemakers, Job; Kester, Arnold; Limburg, Martien

    2014-01-01

    To evaluate the effectiveness of a stroke-specific follow-up care model on quality of life for stroke patients, being discharged home, and their caregivers. A non-randomized, controlled trial, comparing an intervention group with a control group (usual care). Stroke patients and their caregivers. Intervention involved 5 home visits by a stroke care coordinator over a period of 18 months, using a structured assessment tool. Outcome measures were conducted at baseline (T0) and every 6 months thereafter (T6, T12 and T18) in the domains of quality of life (primary), activities of daily living, social activities, depression, anxiety and caregiver strain. The intervention group (n = 62) had significantly increased its social activities after 18 months, whereas the control group (n = 55) showed significantly decreased levels of social activities. In the first 6 months, levels of depression decreased significantly in caregivers of the intervention group. No differences were found for quality of life and the other outcome measures. The intervention was not effective in improving quality of life, but was effective in improving levels of social activities. The intervention may have focussed too much on screening for stroke-related problems and not as much on adequate follow-up care and referral.

  17. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study

    Directory of Open Access Journals (Sweden)

    Price Jackie F

    2011-01-01

    Full Text Available Abstract Background Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Methods Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA trial (N = 11, and AAA trial participants who had stopped taking the trial medication (N = 11. A focus group with further participants who had stopped taking the trial medication (N = 6. (Total participants N = 28. Results Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating. Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. Conclusions These results indicate that when planning trials (especially in preventive medicine particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. Trial registration ISRCTN66587262

  18. Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial.

    Science.gov (United States)

    Nagai, Yoko; Cavanna, Andrea E; Critchley, Hugo D; Stern, Jeremy J; Robertson, Mary M; Joyce, Eileen M

    2014-03-01

    To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome. Despite advances in the pharmacologic treatment of patients with Tourette syndrome, many remain troubled by their tics, which may be resistant to multiple medications at tolerable doses. Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions. We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome. After training the patients for 3 sessions a week over 4 weeks, we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback (control) groups, but there was no difference between the groups in these measurements. Furthermore, the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback. Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo. The main confounding factor appeared to be the 30-minute duration of the training sessions, which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses. Despite a negative finding in this study, electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified.

  19. Checklists of Methodological Issues for Review Authors to Consider When Including Non-Randomized Studies in Systematic Reviews

    Science.gov (United States)

    Wells, George A.; Shea, Beverley; Higgins, Julian P. T.; Sterne, Jonathan; Tugwell, Peter; Reeves, Barnaby C.

    2013-01-01

    Background: There is increasing interest from review authors about including non-randomized studies (NRS) in their systematic reviews of health care interventions. This series from the Ottawa Non-Randomized Studies Workshop consists of six papers identifying methodological issues when doing this. Aim: To format the guidance from the preceding…

  20. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    Science.gov (United States)

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p 70%) compared with most published results with multifocal spectacles. Further studies are warranted to identify the critical factors and mechanisms underlying this myopia control effect.

  1. The chronic care for wet age related macular degeneration (CHARMED) study: a randomized controlled trial

    OpenAIRE

    Markun, Stefan; Dishy, Avraham; Neuner-Jehle, Stefan; Rosemann, Thomas; Frei, Anja

    2015-01-01

    BACKGROUND: In real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM). METHODS: Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, ...

  2. The Chronic Care for Wet Age Related Macular Degeneration (CHARMED) Study: A Randomized Controlled Trial

    OpenAIRE

    Stefan Markun; Avraham Dishy; Stefan Neuner-Jehle; Thomas Rosemann; Anja Frei

    2015-01-01

    Background In real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM). Methods Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, using...

  3. Evaluating cognitive effort in a randomized controlled trial.

    Science.gov (United States)

    Turner, Travis H; Renfroe, Jenna B; Morella, Kristen; Marriott, Bernadette P

    2016-09-01

    Many randomized controlled trials (RCTs) of neuropsychiatric conditions involve cognitive outcome measures; however, validity of cognitive data relies on adequate effort during testing, and such screening is seldom performed. Given well-established rates of 10 to 30% poor effort in clinical settings, this is not a trivial concern. This preliminary study evaluated effort during cognitive testing in an RCT of omega-3 supplementation to reduce suicidality in a high-risk psychiatric population. An interim analysis of sustained attentions measures from the Connors Performance Test (CPT-2) at baseline for the first 60 participants was conducted. Previously validated cut points to detect insufficient effort on the CPT-2 were applied. At baseline, 12% (7) were identified as giving poor effort. Follow-up analyses indicated less psychiatric distress and suicidality among those who gave poor effort. Results suggest comparable likelihood of a poor effort on cognitive testing in clinical and RCT participation. Reduced psychiatric distress in the poor effort group raises concern regarding interpretation of other measures. The importance of screening cognitive data for effort in RCTs is highlighted. Future studies will examine effort at follow-up visits, and explore relationships to attrition, adherence, and response to treatment. Copyright © 2016 John Wiley & Sons, Ltd.

  4. Clinical randomized controlled trial of chemomechanical caries removal (Carisolv).

    Science.gov (United States)

    Lozano-Chourio, M A; Zambrano, O; González, H; Quero, M

    2006-05-01

    The purpose of this study was to compare the chemomechanical caries-removal system (Carisolv) with high-speed excavation in cavitated occlusal caries of primary molars. Design and setting. The study was a randomized controlled, clinical trial in which the two techniques were compared in each subject. Participants were chosen from public schools, in Maracaibo County, Zulia State, Venezuela. The sample consisted of 80 primary molars selected from 40 children (mean age 7.7+/-0.7 years). Each patient had at least two contralateral primary molars with cavitated occlusal caries and approximately equal-size access to lesions. The outcome variables were: clinically complete caries removal, size of the opening of the cavity, volume of carious tissue removed, pain during caries removal, anaesthesia requested by the patient, caries-removal time, and behaviour and preference of patients. All treated molars were clinically caries free whichever caries-removal procedure was used. When Carisolv' was used the final cavity entrance sizes were smaller (Premoved was less (Premoval was three times longer (7.51+/-1.83 min, Premoval of occlusal dentinal caries in cavitated primary molars; it is more conservative of dental tissue and appeared to be more comfortable for most patients, although the clinical time spent is longer than when using high-speed excavation.

  5. Pneumatic retinopexy versus scleral buckling: a randomised controlled trial.

    Science.gov (United States)

    Mulvihill, A; Fulcher, T; Datta, V; Acheson, R

    1996-01-01

    Pneumatic retinopexy (PR) is a technique for repairing certain retinal detachments which is easier to perform than conventional sceral buckling (SB) surgery but has comparable results. We performed a prospective, randomised, controlled trial to determine for ourselves whether PR is a safe and acceptable procedure. Twenty patients presenting consecutively with retinal detachments which fulfilled the selection criteria were randomised to have their detachments repaired by either PR or SB, ten patients in each group. The suitable patients had a single retinal break or small group of breaks of not greater than one clock hour in size, situated within the superior eight clock hours of retina. Patients with significant proliferative vitreoretinopathy or other fundus disorders were excluded. All patients in the PR group had local anaesthesia while all those in the SB group had general anaesthesia. Successful reattachment of the retina was achieved with one or more procedures in 90 percent of the PR group and in 100 percent of the SB group. We feel that narrowing the selection criteria for PR may further improve the success rate.

  6. Improving pediatric prevention via the internet: a randomized, controlled trial.

    Science.gov (United States)

    Christakis, Dimitri A; Zimmerman, Frederick J; Rivara, Frederick P; Ebel, Beth

    2006-09-01

    Innovations to improve the delivery of pediatric preventive care are needed. We enrolled children, 0 to 11 years of age, into a factorial, randomized, controlled trial of a tailored, evidence-based, Web site (MyHealthyChild) that provided information on prevention topics before a scheduled well-child visit. There were 2 components of the intervention, namely, parental Web content and provider notification. Parental Web content provided information to parents about prevention topics; provider notification communicated to physicians topics that were of interest to parents. We assigned 887 children randomly to 4 groups (usual care, content only, content and notification, or notification only). Outcomes were determined with telephone follow-up surveys conducted 2 to 4 weeks after the visit. Poisson regression analysis was used to determine the independent effects of each intervention on the number of topics discussed and the number of preventive practices implemented. Parents in the notification/content group and in the notification-only group reported discussing more MyHealthyChild topics with their provider. Parents in the notification/content group and in the content-only group reported implementing more MyHealthyChild topic suggestions (such as use of a safety device). A Web-based intervention can activate parents to discuss prevention topics with their child's provider. Delivery of tailored content can promote preventive practices.

  7. [Review of controled clinical trials of behavioral treatment for obesity].

    Science.gov (United States)

    Márquez-Ibáñez, B; Armendáriz-Anguiano, A L; Bacardí-Gascón, M; Jiménez-Cruz, A

    2008-01-01

    The increased prevalence of obesity has been associated to an increment in chronic-degenerative diseases. The behavioral conduct therapies (BCT) have been used to help subjects develop a series of skills to reach a healthy weight. We conducted a review of the literature of BCT from controlled clinical trials registered at PubMed from January 2000 to november 2006. We found five long-term (> or = 12 months) studies and analyzed each study. The percent of weight loss at the end of follow up ranged from 3% to 9% of the initial weight; the percent of retention fluctuated from 92% at three months to 55% at 24 months. There were no similar reported studies conducted in Latino or Hispanic population. These results suggest that the change in loss of weight with BCT are modest at the end of the follow up period and that most of the studies report low adherence to treatment. It is recommended that public and private funds are needed to implement effective and safe multicentric long term randomized studies on different cultural populations, including most Latin-American countries.

  8. Validating Obstetric Emergency Checklists using Simulation: A Randomized Controlled Trial.

    Science.gov (United States)

    Bajaj, Komal; Rivera-Chiauzzi, Enid Y; Lee, Colleen; Shepard, Cynthia; Bernstein, Peter S; Moore-Murray, Tanya; Smith, Heather; Nathan, Lisa; Walker, Katie; Chazotte, Cynthia; Goffman, Dena

    2016-10-01

    Background The World Health Organization's Surgical Safety Checklist has demonstrated significant reduction in surgical morbidity. The American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative (SMI) safety bundles include eclampsia and postpartum hemorrhage (PPH) checklists. Objective To determine whether use of the SMI checklists during simulated obstetric emergencies improved completion of critical actions and to elicit feedback to facilitate checklist revision. Study Design During this randomized controlled trial, teams were assigned to use a checklist during one of two emergencies: eclampsia and PPH. Raters scored teams on critical step completion. Feedback was elicited through structured debriefing. Results In total, 30 teams completed 60 scenarios. For eclampsia, trends toward higher completion were noted for blood pressure and airway management. For PPH, trends toward higher completion rates were noted for PPH stage assessment and fundal massage. Feedback resulted in substantial checklist revision. Participants were enthusiastic about using checklists in a clinical emergency. Conclusion Despite trends toward higher rates of completion of critical tasks, teams using checklists did not approach 100% task completion. Teams were interested in the application of checklists and provided feedback necessary to substantially revise the checklists. Intensive implementation planning and training in use of the revised checklists will result in improved patient outcomes.

  9. Sexual Absorption of Vaginal Progesterone: A Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Kathryn S. Merriam

    2015-01-01

    Full Text Available Objective. To determine if sexual intercourse reduces absorption of vaginal progesterone gel in women and to determine if progesterone is absorbed by the male during intercourse. Study Design. Prospective, randomized, cross over, controlled study of 20 reproductive-aged women and their male sexual partners randomized to receive vaginal progesterone gel (Crinone 8% gel, Actavis Inc., USA or placebo cream. Serum progesterone for both male and female partners were measured 10 hours after intercourse. One week later, subjects were crossed over to receive the opposite formulation. In the third week, women used progesterone gel at night and abstained from intercourse. Results. Serum progesterone was significantly reduced with vaginal progesterone gel + intercourse compared with vaginal progesterone gel + abstinence (P=0.0075. Men absorbed significant progesterone during intercourse with a female partner using vaginal progesterone gel compared to placebo (P=0.0008. Conclusion(s. Vaginal progesterone gel is reduced in women after intercourse which may decrease drug efficacy during luteal phase support. Because men absorb low levels of progesterone during intercourse, exposure could cause adverse effects such as decreased libido. This study is registered under Clinical Trial number NCT01959464.

  10. Is the randomized controlled drug trial in Europe lagging behind the USA?

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo J.; Knol, Mirjam J.; Tijssen, Robert J. W.; van Leeuwen, Thed N.; Grobbee, Diederick E.; de Zeeuw, Dick

    2008-01-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT? center dot The USA, UK and Germany have a strong position in performance of drug and nondrug randomized controlled trials. center dot Europe's position in the quantitative and qualitative performance in drug randomized controlled trials in particular, and fa

  11. Acceptance and commitment therapy for fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Wicksell, R K; Kemani, M; Jensen, K; Kosek, E; Kadetoff, D; Sorjonen, K; Ingvar, M; Olsson, G L

    2013-04-01

    Fibromyalgia (FM) is characterized by widespread pain and co-morbid symptoms such as fatigue and depression. For FM, medical treatments alone appear insufficient. Recent meta-analyses point to the utility of cognitive behaviour therapy (CBT), but effects are moderate. Within the continuous development of CBT, the empirical support for acceptance and commitment therapy (ACT) has increased rapidly. ACT focuses on improving functioning by increasing the patient's ability to act in accordance with personal values also in the presence of pain and distress (i.e., psychological flexibility). However, no study has yet explored the utility of ACT in FM. To evaluate the efficacy of ACT for FM and the role of psychological inflexibility as a mediator of improvement. In this randomized controlled trial, ACT was evaluated in comparison to a waiting list control condition. Forty women diagnosed with FM participated in the study. Assessments were made pre- and post-treatment and at 3 months of follow-up. The ACT intervention consisted of 12 weekly group sessions. Significant differences in favour of ACT were seen in pain-related functioning, FM impact, mental health-related quality of life, self-efficacy, depression, anxiety and psychological inflexibility. Changes in psychological inflexibility during the course of treatment were found to mediate pre- to follow-up improvements in outcome variables. The results correspond with previous studies on ACT for chronic pain and suggest the utility of ACT for FM as well as the role of psychological inflexibility as a mediator of improvement. © 2012 European Federation of International Association for the Study of Pain Chapters.

  12. Phytothermotherapy in osteoarthritis: a randomized controlled clinical trial.

    Science.gov (United States)

    Fioravanti, Antonella; Bellisai, Barbara; Iacoponi, Francesca; Manica, Patrizia; Galeazzi, Mauro

    2011-05-01

    The aim of this study was to assess the efficacy of adding a cycle of phytothermotherapy (a traditional treatment with fermenting grass used in Trentino-Alto Adige, Italy) to the usual drug treatment, in patients with primary symptomatic osteoarthritis (OA) of the knee, hip, or lumbar spine. In this randomized, single-blind, controlled trial, 218 outpatients were enrolled; 109 patients were treated with a cycle of phytothermotherapy at the thermal resort of Garniga Terme (Trento, Italy) for 10 days; the other 109 patients continued regular outpatient care. Patients were assessed at baseline, after 2 weeks, and after 3 months from the beginning of the study and were evaluated using a visual analogue scale (VAS) for spontaneous pain, a Health Assessment Questionnaire, the Lequesne index for hip and knee osteoarthritis, and the Rolland Morris Questionnaire for lumbar spine OA and symptomatic drug consumption. In patients treated with phytothermotherapy, a significant improvement of VAS and a reduction of nonsteroidal anti-inflammatory drug consumption at the end of treatment and 3 months later were observed. In the control group, no significant differences were noted. The analyses performed separately for each subgroup for OA localization showed that the best results were evident in lumbar spine OA. Concerning tolerability, in the group treated with phytothermotherapy 10% of patients presented side-effects due to treatment, but these were of low intensity and did not interrupt the therapy. In conclusion, the results show beneficial effects of a cycle of phytothermotherapy in patients with OA of the hip, knee, or lumbar spine. Phytothermotherapy may therefore be a useful aid alongside the usual pharmacologic and physiokinesic therapies, or may be used as a valid alternative for patients who do not tolerate pharmacologic treatments.

  13. Guidelines for controlled trials of drugs in tension-type headache: second edition

    DEFF Research Database (Denmark)

    Bendtsen, L; Bigal, M E; Cerbo, R

    2010-01-01

    controlled trials are the only way to convincingly demonstrate the efficacy of a drug, and form the basis for international agreement on drug therapy'. The Committee published similar guidelines for clinical trials in migraine and cluster headache. Since 1995 several studies on the treatment of episodic......The Clinical Trials Subcommittee of the International Headache Society published its first edition of the guidelines on controlled trials of drugs in tension-type headache in 1995. These aimed 'to improve the quality of controlled clinical trials in tension-type headache', because 'good quality...... and chronic tension-type headache have been published, providing new information on trial methodology for this disorder. Furthermore, the classification of the headaches, including tension-type headache, has been revised. These developments support the need for also revising the guidelines for drug treatments...

  14. Echinacea for treating the common cold: A randomized controlled trial

    Science.gov (United States)

    Barrett, Bruce; Brown, Roger; Rakel, Dave; Mundt, Marlon; Bone, Kerry; Barlow, Shari; Ewers, Tola

    2011-01-01

    Background Echinacea is widely used to treat common cold. Objective To assess potential benefits of echinacea as common cold treatment. Design Randomized controlled trial with four parallel groups: 1) no pills, 2) placebo pills (blinded), 3) echinacea pills (blinded), or 4) echinacea pills (open-label). (NCT00065715) Setting Community-based trial. Participants People aged 12 to 80 years with new onset common cold. Interventions Extracts of Echinacea purpurea and E. angustifolia root were used to make tablets standardized to alkamide content. Indistinguishable placebo tablets contained only inert ingredients. Measurements The primary outcome was area-under-the-curve global severity, with severity assessed twice daily by self report on the Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Secondary outcomes included interleukin-8 and neutrophil count from nasal wash assessed at intake and two days later. Results Of 719 enrolled, 713 completed the protocol. Participants were 64% female and 88% white, with mean age 33.7 years. Mean global severity was 236 and 258 for blinded and unblinded echinacea, 264 for blinded placebo, and 286 for those without pills. Contrasting the two blinded groups yields a 28 point (95% CI = −69 to 13) trend toward benefit for echinacea (p=0.089). Mean illness duration for the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared to 6.87 days for blinded placebo and 7.03 for no pills. Contrasting blinded groups yields a 0.53 day (95% CI = −1.25 to 0.19) trend toward benefit (p = 0.075). Median change interleukin-8 (pg/mL) and neutrophil cell count were: no pills (30, 1), blinded placebo (39, 1), blinded echinacea (58, 2), and open-label echinacea (70, 1), also not statistically significant. Limitations Higher-than-expected variability limited power to detect small-but-potentially-important benefits. Conclusions The observed shorter illness duration and lower severity seen in the echinacea groups were

  15. Probiotics in the prevention of eczema: a randomised controlled trial

    Science.gov (United States)

    Allen, Stephen J; Jordan, Sue; Storey, Melanie; Thornton, Catherine A; Gravenor, Michael B; Garaiova, Iveta; Plummer, Susan F; Wang, Duolao; Morgan, Gareth

    2014-01-01

    Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebo-controlled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20; total of 1010 organisms/day) or matching placebo. Main outcome measure Diagnosed eczema at age 2 years. Infants were followed up by questionnaire. Clinical examination and skin prick tests to common allergens were done at 6 months and 2 years. Results The cumulative frequency of diagnosed eczema at 2 years was similar in the probiotic (73/214, 34.1%) and placebo arms (72/222, 32.4%; OR 1.07, 95% CI 0.72 to 1.6). Among the secondary outcomes, the cumulative frequency of skin prick sensitivity at 2 years was reduced in the probiotic (18/171; 10.5%) compared with the placebo arm (32/173; 18.5%; OR 0.52, 95% CI 0.28 to 0.98). The statistically significant differences between the arms were mainly in sensitisation to cow's milk and hen's egg proteins at 6 months. Atopic eczema occurred in 9/171 (5.3%) children in the probiotic arm and 21/173 (12.1%) in the placebo arm (OR 0.40, 95% CI 0.18 to 0.91). Conclusions The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity. However, the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood. Trial registration Number ISRCTN26287422. PMID:24947281

  16. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an interm

  17. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    NARCIS (Netherlands)

    Venekamp, R.P.; Bonten, M.J.; Rovers, M.M.; Verheij, T.J.; Sachs, A.P.

    2012-01-01

    BACKGROUND: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic cort

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

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

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

  19. Predictors of Missed Research Appointments in a Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stéphanie J.E. Becker

    2014-09-01

     Younger patients with no college education, who believe their health can be controlled, are more likely to miss a research appointment when enrolled in a randomized placebo injection-controlled trial

  20. Control Group Design, Contamination and Drop-Out in Exercise Oncology Trials : A Systematic Review

    NARCIS (Netherlands)

    Bisschop, Charlotte N. Steins; Courneya, Kerry S.; Velthuis, Miranda J.; Monninkhof, Evelyn M.; Jones, Lee W.; Friedenreich, Christine; van der Wall, Elsken; Peeters, Petra H. M.; May, Anne M.

    2015-01-01

    Purpose Important considerations for exercise trials in cancer patients are contamination and differential drop-out among the control group members that might jeopardize the internal validity. This systematic review provides an overview of different control groups design characteristics of

  1. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia : a randomised equivalence trial

    NARCIS (Netherlands)

    Logtenberg, Slm; Oude Rengerink, K; Verhoeven, C J; Freeman, L M; van den Akker, Esa; Godfried, M B; van Beek, E; Borchert, Owhm; Schuitemaker, N; van Woerkens, Ecsm; Hostijn, I; Middeldorp, J M; van der Post, J A; Mol, B W

    OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the

  2. A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007

    Directory of Open Access Journals (Sweden)

    Thomson Denise

    2010-12-01

    Full Text Available Abstract Background Randomized controlled trials (RCTs are the gold standard for trials assessing the effects of therapeutic interventions; therefore it is important to understand how they are conducted. Our objectives were to provide an overview of a representative sample of pediatric RCTs published in 2007 and assess the validity of their results. Methods We searched Cochrane Central Register of Controlled Trials using a pediatric filter and randomly selected 300 RCTs published in 2007. We extracted data on trial characteristics; outcomes; methodological quality; reporting; and registration and protocol characteristics. Trial registration and protocol availability were determined for each study based on the publication, an Internet search and an author survey. Results Most studies (83% were efficacy trials, 40% evaluated drugs, and 30% were placebo-controlled. Primary outcomes were specified in 41%; 43% reported on adverse events. At least one statistically significant outcome was reported in 77% of trials; 63% favored the treatment group. Trial registration was declared in 12% of publications and 23% were found through an Internet search. Risk of bias (ROB was high in 59% of trials, unclear in 33%, and low in 8%. Registered trials were more likely to have low ROB than non-registered trials (16% vs. 5%; p = 0.008. Effect sizes tended to be larger for trials at high vs. low ROB (0.28, 95% CI 0.21,0.35 vs. 0.16, 95% CI 0.07,0.25. Among survey respondents (50% response rate, the most common reason for trial registration was a publication requirement and for non-registration, a lack of familiarity with the process. Conclusions More than half of this random sample of pediatric RCTs published in 2007 was at high ROB and three quarters of trials were not registered. There is an urgent need to improve the design, conduct, and reporting of child health research.

  3. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study.

    Science.gov (United States)

    Lewin, Simon; Glenton, Claire; Oxman, Andrew D

    2009-09-10

    To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions. Review of randomised controlled trials of interventions to change professional practice or the organisation of care. Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group. Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done. 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable. Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.

  4. 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.

  5. Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial.

    Science.gov (United States)

    Lao, Lixing; Huang, Yi; Feng, Chiguang; Berman, Brian M; Tan, Ming T

    2012-03-30

    Traditional Chinese medicine (TCM), used in China and other Asian counties for thousands of years, is increasingly utilized in Western countries. However, due to inherent differences in how Western medicine and this ancient modality are practiced, employing the so-called Western medicine-based gold standard research methods to evaluate TCM is challenging. This paper is a discussion of the obstacles inherent in the design and statistical analysis of clinical trials of TCM. It is based on our experience in designing and conducting a randomized controlled clinical trial of acupuncture for post-operative dental pain control in which acupuncture was shown to be statistically and significantly better than placebo in lengthening the median survival time to rescue drug. We demonstrate here that PH assumptions in the common Cox model did not hold in that trial and that TCM trials warrant more thoughtful modeling and more sophisticated models of statistical analysis. TCM study design entails all the challenges encountered in trials of drugs, devices, and surgical procedures in the Western medicine. We present possible solutions to some but leave many issues unresolved.

  6. Metabolic deterioration of the sedentary control group in clinical trials

    National Research Council Canada - National Science Library

    Mahesh J. Patel; Cris A. Slentz; William E. Kraus

    2011-01-01

    Randomized clinical trials of exercise training regimens in sedentary individuals have provided a mechanistic understanding of the long-term health benefits and consequences of physical activity and inactivity...

  7. Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

    Directory of Open Access Journals (Sweden)

    Norio Sugawara

    Full Text Available Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251 aged 47.7±13.2 (mean±SD with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.

  8. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    Directory of Open Access Journals (Sweden)

    Rahu Mati

    2008-08-01

    Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may

  9. Comparison communities in a cluster randomised trial innovate in response to 'being controlled'.

    Science.gov (United States)

    Hawe, Penelope; Riley, Therese; Gartrell, Alexandra; Turner, Karen; Canales, Claudia; Omstead, Darlene

    2015-05-01

    We conducted qualitative interviews among primary health care teams and community agencies in eight communities in Victoria, Australia which had (1) agreed to be part of a universal primary care and community development intervention to reduce post natal depression and promote maternal health; and (2) were randomised to the comparison arm. The purpose was to document their experience with and interpretation of the trial. Although 'control' in a controlled trial refers to the control of confounding of the trial result by factors other than allocation to the intervention, participants interpreted 'control' to mean restrictions on what they were allowed to do during the trial period. They had agreed not to use the Edinburgh Post Natal Depression Scale or the SF 36 in clinical practice and not to implement any of the elements of the intervention. We found that no elements of the intervention were implemented. However, the extension of the trial from three to five years made the trial agreement a strain. The imposition of trial conditions also encouraged a degree of lateral thinking and innovation in service delivery (quality improvement). This may have potentially contributed to the null trial results. The observations invite interrogation of intervention theory and consequent rethinking of the way contamination in a cluster trial is defined.

  10. Randomized Controlled Trials of Pediatric Massage: A Review

    Directory of Open Access Journals (Sweden)

    Shay Beider

    2007-01-01

    Full Text Available The existing reviews of massage therapy (MT research are either limited to infants, adults, or were conducted prior to the publication of the most recent studies using pediatric samples. Randomized controlled trials (RCTs of pediatric MT are reviewed. A literature search yielded 24 RCTs of pediatric MT, defined as the manual manipulation of soft tissue intended to promote health and well-being in recipients between 2 and 19 years of age. Because RCTs of pediatric MT varied considerably in the amount and types of data reported, quantitative and narrative review methods were both used. Single-dose and multiple-dose effects were examined separately. Among single-dose effects, significant reductions of state anxiety were observed at the first session (g = 0.59, P < 0.05 and the last session (g = 1.10, P < 0.01 of a course of treatment. Effects for salivary cortisol (g = 0.28, negative mood (g = 0.52 and behavior (g = 0.37 were non-significant. Three of eleven multiple-dose effects were statistically significant. These were trait anxiety (g = 0.94, P < 0.05, muscle tone (g = 0.90, P < 0.01 and arthritis pain (g = 1.33, P < 0.01. Results of studies not permitting effect size calculation were judged to be generally consistent with quantitative results. MT benefits pediatric recipients, though not as universally as sometimes reported. Numerous weaknesses endemic to MT research (e.g. low statistical power, frequent failure to report basic descriptive statistics are identified, and recommendations for future pediatric MT research are discussed.

  11. Exercise training and habitual physical activity: a randomized controlled trial.

    Science.gov (United States)

    Swift, Damon L; Johannsen, Neil M; Tudor-Locke, Catrine; Earnest, Conrad P; Johnson, William D; Blair, Steven N; Sénéchal, Martin; Church, Timothy S

    2012-12-01

    Exercise training reduces adiposity and risk of cardiovascular disease. However, the combined effects of habitual free-living physical activity and aerobic training on waist circumference, weight, fitness, and blood pressure in postmenopausal women are unknown. To evaluate the effects of habitual physical activity levels during aerobic training on weight, waist circumference, fitness, and blood pressure. Secondary analysis of an RCT. Original data collected April 2001 to June 2005 and analyzed in 2012. Postmenopausal women in a supervised exercise trial. Women (n=325) were randomized to 4, 8, or 12 kcal/kg per week of aerobic training or a control group for 6 months. All outcome measures were collected at baseline and follow-up. Changes in dependent variables within each training group were evaluated across tertiles of pedometer-determined habitual physical activity outside exercise training sessions. Changes in waist circumference and weight. Reductions in waist circumference were significantly greater with higher steps/day accumulated outside exercise training compared to lower levels in the 4 (high: -4.8 cm vs low: -1.4 cm, p=0.03); 8 (high: -4.2 cm vs low: -0.4 cm, p=0.03), and 12 kcal/kg per week groups (high: -4.1 cm vs low: -0.7 cm, p=0.05). For all groups, p-trend≤0.03. A trend was observed for greater weight reduction with higher steps/day in the 4 kcal/kg per week group (p-trend=0.04) but not for the other exercise doses. No effects were observed for blood pressure or fitness measures (all p>0.05). In postmenopausal women, higher habitual physical activity while participating in aerobic training was associated with greater reductions in central adiposity, and was supportive of weight loss compared to lower levels. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  12. ASSESSMENT OF AMLODIPINE ANTIHYPERTENSIVE EFFECT HOMOGENEITY IN CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    V. M. Gorbunov

    2016-01-01

    Full Text Available Aim. To compare influence of amlodipine and spirapril on ambulatory blood pressure profile, including antihypertensive effect smoothness in patients with arterial hypertension (HT.Methods. 39 patients (aged 53,7±10,0 y.o. with HT were included in the open, randomized, cross-over study, 30 patients completed study. The duration of every therapies was 4 weeks, initial control period and wash-out period between therapies lasted 1 week. The initial daily dose of amlodipine was 5 mg, standard dose of spirapril (6 mg/daily was not changed during the trial. After 1-2 weeks of treatment amlodipine dose was increased up to 10 mg/daily as well as dihydrochlorothiazide was added, if necessary. Ambulatory blood pressure monitoring (ABPM was performed initially and at the end of both therapies.Results. Both drugs demonstrated good antihypertensive effect according to ABPM data. Decrease of systolic/diastolic blood pressure was 11,2±1,8/7,6±1,2 mm Hg in amlodipine therapy and 10,0±1,8/7,1±1,2 in spirapril therapy (p<0,0001. The smoothness indexes (SI were 0,65/0,45 and 0,55/0,45, respectively, differences between two therapies were not significant. However the individual analysis of the SI distribution (with SI=0,5 as a satisfactory criterion, showed that antihypertensive effect smoothness is better in amlodipine therapy than this in spirapril one.Conclusion. Amlodipine has prominent as well as smooth antihypertensive effect, that gives it advantages in the long-term antihypertensive therapy.

  13. Preventing deformational plagiocephaly through parent guidance: a randomized, controlled trial.

    Science.gov (United States)

    Aarnivala, Henri; Vuollo, Ville; Harila, Virpi; Heikkinen, Tuomo; Pirttiniemi, Pertti; Valkama, A Marita

    2015-09-01

    Deformational plagiocephaly (DP) occurs frequently in otherwise healthy infants. Many infants with DP undergo physiotherapy or helmet therapy, and ample treatment-related research is available. However, the possibility of preventing DP has been left with little attention. We sought to evaluate the effectiveness of intervention in the newborn's environment, positioning, and handling on the prevalence of DP at 3 months and to investigate the causal relationship between DP and cervical imbalance. We carried out a randomized controlled trial, with healthy newborns randomized into two groups at birth. All families received standard positioning instructions to prevent SIDS. Additionally, the intervention group received detailed instructions regarding the infant's environment, positioning, and handling, with the goal of creating a nonrestrictive environment that promotes spontaneous physical movement and symmetrical motor development. Two- and three-dimensional photogrammetry served to assess cranial shape and goniometry to measure cervical motion. At 3 months, the prevalence of DP was lower in the intervention group in both 2D (11 vs 31 %) and 3D analyses (15 vs 33 %), and the asymmetry was milder in the intervention group. Infants with DP at follow-up had also developed more torticollis. An early educational intervention reduces the prevalence and severity of DP at 3 months. •Deformational plagiocephaly, often with associated torticollis, is common in healthy infants. •Parental education is frequently recommended for preventing deformational plagiocephaly, although information regarding the effectiveness of preventive strategies is scarce. •Early parent guidance effectively reduces the prevalence and severity of DP and improves the cervical range of motion at three months. •Educating both parents and professionals about proper infant positioning on a national scale could help minimize public healthcare costs.

  14. Extended treatment for cigarette smoking cessation: a randomized control trial.

    Science.gov (United States)

    Laude, Jennifer R; Bailey, Steffani R; Crew, Erin; Varady, Ann; Lembke, Anna; McFall, Danielle; Jeon, Anna; Killen, Diana; Killen, Joel D; David, Sean P

    2017-08-01

    To test the potential benefit of extending cognitive-behavioral therapy (CBT) relative to not extending CBT on long-term abstinence from smoking. Two-group parallel randomized controlled trial. Patients were randomized to receive non-extended CBT (n = 111) or extended CBT (n = 112) following a 26-week open-label treatment. Community clinic in the United States. A total of 219 smokers (mean age: 43 years; mean cigarettes/day: 18). All participants received 10 weeks of combined CBT + bupropion sustained release (bupropion SR) + nicotine patch and were continued on CBT and either no medications if abstinent, continued bupropion + nicotine replacement therapy (NRT) if increased craving or depression scores, or varenicline if still smoking at 10 weeks. Half the participants were randomized at 26 weeks to extended CBT (E-CBT) to week 48 and half to non-extended CBT (no additional CBT sessions). The primary outcome was expired CO-confirmed, 7-day point-prevalence (PP) at 52- and 104-week follow-up. Analyses were based on intention-to-treat. PP abstinence rates at the 52-week follow-up were comparable across non-extended CBT (40%) and E-CBT (39%) groups [odds ratio (OR) = 0.99; 95% confidence interval (CI) = 0.55, 1.78]. A similar pattern was observed across non-extended CBT (39%) and E-CBT (33%) groups at the 104-week follow-up (OR = 0.79; 95% CI= 0.44, 1.40). Prolonging cognitive-behavioral therapy from 26 to 48 weeks does not appear to improve long-term abstinence from smoking. © 2017 Society for the Study of Addiction.

  15. 骨髓血移植结合髓芯减压治疗早期股骨头坏死:非随机对照%Bone marrow transplantation and core decompression for treatment of early necrosis of the femoral head: A non-randomized controlled study

    Institute of Scientific and Technical Information of China (English)

    覃学流; 辛晓东; 王大伟; 陈跃平; 林宗汉; 韩杰; 覃杰

    2012-01-01

    背景:骨髓间充质干细胞移植治疗股骨头缺血性坏死成为近年研究的热门课题,而单纯髓芯减压治疗存在争议,那么当髓芯减压复合自体骨髓血移植联合治疗效果如何呢?目的:探讨髓芯减压复合骨髓移植对治疗早期股骨头坏死的临床疗效.方法:纳入采用髓芯减压复合浓集骨髓血移植治疗早期非创伤性股骨头坏死患者20例25髋设为治疗组,采用单纯髓芯减压20例23髋设为对照组.结果与结论:随访6~36个月,根据蒋协远JOA髋关节功能判定标准及宾夕法尼亚州立大学骨坏死的放射学分期系统判定,治疗组总显效率达84%,对照组总显效率65%.髓芯减压复合骨髓移植治疗股骨头坏死,损伤小、疗效好,对早期股骨头坏死的患者能获得较好的临床疗效,远期疗效有待进一步探讨.%BACKGROUND: Bone marrow transplantation for the treatment of femoral head necrosis becomes a hot research topic in recent years, while the role of core decompression in the treatment is in dispute. The combined therapeutic effect of core decompression and bone marrow transplantation in treatment of femoral head necrosis is unclear.OBJECTIVE: To explore the combined therapeutic effect of core decompression and bone marrow transplantation in treatment of early necrosis of the femoral head.METHODS: Patients with early non-traumatic necrotic femoral head were included. Twenty of them with 25 hips treated by core decompression and concentrated bone marrow transplantation were taken as treatment group. Twenty patients with 23 hips in the control group underwent simple core decompression.RESULTS AND CONCLUSION: Following 6-36 months follow-up, the total efficiency rate of the treatment group was 84% and that was 65% in the control group according to the hip function criteria of Japanese Orthopaedic Association and the Radiology Stage System of bone necrosis of Pennsylvania State University. Core decompression combined with bone

  16. A randomised controlled trial of Silirum vaccine for control of paratuberculosis in farmed red deer.

    Science.gov (United States)

    Stringer, L A; Wilson, P R; Heuer, C; Mackintosh, C G

    2013-12-07

    A randomised controlled trial to assess the efficacy of Silirum vaccine in control of paratuberculosis in young farmed deer was carried out in 2008-2009 in six New Zealand herds with a history of clinical disease. Vaccination with Silirum was carried out in four-month-old deer, and vaccinates (n=1671) and controls (n=1664) were weighed at vaccination and at 8 and 12 months old, when faecal samples were collected from 125 vaccinates and 123 controls on five farms. Deer were slaughtered between 11 and 20 months of age, and the incidence of gross visceral lymph node (VLN) pathology typical of paratuberculosis in deer, that is, enlarged and/or granulomatous VLN, was recorded. Clinical disease was confirmed in 18 controls and seven vaccinates, representing a vaccine efficacy estimate of 60 per cent (95% CI 3 per cent to 83 per cent, P=0.04). Forty-seven percent (95% CI 38 per cent to 56 per cent) of faecal samples from vaccinates and 55 per cent (95% CI 46 per cent to 64 per cent) from controls were Mycobacterium avium subspecies paratuberculosis positive (P=0.5). Average daily liveweight gain did not differ between the cohorts. At slaughter, 1.4 per cent of vaccinates and 4.5 per cent of controls had VLN pathology, RR=0.32 (95% CI 0.19 to 0.54, Pvaccination with Silirum may be useful as an aid to control losses associated with clinical paratuberculosis in young deer.

  17. Massage Therapy and Labor Outcomes: a Randomized Controlled Trial

    Science.gov (United States)

    Janssen, Patricia; Shroff, Farah; Jaspar, Paula

    2012-01-01

    Introduction Massage is a time-honored method by which women have received comfort throughout the millennia, yet it has not been rigorously evaluated in the modern day delivery suite. No study to date that we are aware of has evaluated the effect of massage therapy by a regulated massage therapist on labor pain. The purpose of this study was to evaluate the effectiveness of massage therapy provided by registered massage therapists in managing pain among women in active labor. Methods BC Women’s Hospital, Vancouver, BC. Research Design: a randomized controlled trial. Participants: 77 healthy nulliparous women presenting in spontaneous labor. Intervention: Swedish massage administered for up to five hours by a registered massage therapist during labor vs. standard care. Main outcome measures include: cervical dilation at the time of administration of epidural, compared using estimated marginal means in an analysis of covariance. We also compared perception of pain at three time periods during labor according to cervical dilation at 3–4 cm, 5–7 cm, and 8–10 cm using the McGill Present Pain Intensity Scale. Results The mean cervical dilation at the time of epidural insertion after adjustment for station of the presenting part, cervical dilation, and status of membranes on admission to hospital was 5.9 cm (95% CI 5.2–6.7) compared to 4.9 in the control group (95% CI 4.2–5.8). Scores on the McGill Pain Scale were consistently lower in the massage therapy group (13.3 vs. 16.9 at 3–4 cm, 13.3 vs. 15.8 at 5–6 cm, and 19.4 vs. 28.3 at 7–8 cm), although these differences were not statistically significant. Conclusions Our findings from this pilot study suggest that massage therapy by a registered massage therapist has the potential to be an effective means of pain management that may be associated with delayed use of epidural analgesia. It may therefore have the potential to reduce exposure to epidural analgesia during labor and decrease rates of associated

  18. Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial.

    Science.gov (United States)

    Hillier, Sharon L; Nyirjesy, Paul; Waldbaum, Arthur S; Schwebke, Jane R; Morgan, Franklin G; Adetoro, Nikki A; Braun, Carol J

    2017-08-01

    To evaluate secnidazole as a single oral dose treatment for bacterial vaginosis in a phase 2 randomized, double-blind, placebo-controlled study. In a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study, women with bacterial vaginosis who met all Amsel criteria (discharge; pH 4.7 or greater; 20% or greater clue cells; positive whiff test) were randomized one to one to one at 24 U.S. centers to 1 or 2 g secnidazole compared with placebo. The primary endpoint was clinical cure (normalization of discharge, amine odor, and clue cells) 21-30 days after treatment. Secondary endpoints included microbiologic cure, defined as a Nugent score of 0-3, and therapeutic cure, defined as meeting criteria for both clinical and microbiologic cure. The modified intent to treat was used for efficacy analyses and included all randomized patients who met the enrollment criteria. Assuming a clinical cure rate of 40% in the active groups and 15% in the placebo group, a sample size of 52 patients per group provided approximately 80% power to detect a significant difference between groups (.05 level [two-sided]) using a Cochran-Mantel-Haenszel test. Between May and September 2014, 215 patients were enrolled. In the intent-to-treat population, the clinical cure rate was 65.3% for the 2-g group, 49.3% for the 1-g group, and 19.4% for the placebo group. The modified intent-to-treat population included 188 women (median age 33 years; 32% with four or more bacterial vaginosis episodes in the previous year; 54% black) with baseline Nugent scores 4 or greater. Clinical, microbiologic, and therapeutic cure rates were 67.7%, 40.3%, and 40.3% for 2 g secnidazole and 51.6%, 23.4%, and 21.9% for 1 g secnidazole compared with 17.7%, 6.5%, and 6.5% for placebo, respectively (Pbacterial vaginosis treatment (Pbacterial vaginosis treatment. ClinicalTrials.gov, NCT02147899.

  19. Meta-analysis of non-randomized studies in interventional cardiology: a critical appraisal

    Directory of Open Access Journals (Sweden)

    Eliano Pio Navarese

    2009-12-01

    Full Text Available Utilisation of meta-analysis is becoming more and more common in interventional cardiology. The aim of this statistical approach is to collect a large number of patients from randomized clinical studies and nonrandomized registries in order to obtain a pooled estimate of the results. Nevertheless, simply pooling these results without a correct methodological approach can easily lead to biased conclusions. In this report we analyse the possible methodological drawbacks of such an approach and we suggest a simplified check-list of items to be considered in the effort of building-up a meta-analysis from non-randomized studies.

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

    OpenAIRE

    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...

  1. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique.

    Directory of Open Access Journals (Sweden)

    Jing-Yu Tan

    Full Text Available To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method.Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from inception to July 3, 2014. Meanwhile, eight Chinese journals on complementary and alternative medicine were manually searched to locate eligible articles. In addition, eligible studies listed in the reference lists of the included papers and other related systematic reviews on acupressure were also screened to further search any potentially eligible trials. Methodological quality of the included studies was evaluated using the risk of bias assessment tool developed by the Cochrane Back Review Group. Descriptive analysis was adopted to summarize the therapeutic outcomes.Sixty-six studies with 7265 participants were included. Methodological quality of the included trials was generally satisfactory. Six types of sham acupressure approaches were identified and "non-acupoint" stimulation was the most frequently utilized sham point while an acupressure device was the most commonly used approach for administering sham treatments. Acupressure therapy was a beneficial approach in managing a variety of health problems and the therapeutic effect was found to be more effective in the true acupressure groups than that in the sham comparative groups. No clear association could be identified between different sham acupressure modalities and the reported treatment outcomes.A great diversity of sham acupressure controls have been used in clinical practice and research. A solid conclusion whether different sham alternatives are related to different treatment outcomes cannot be derived because of

  2. Complementary feeding: a Global Network cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pasha Omrana

    2011-01-01

    Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

  3. 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

  4. Blinding in randomized control trials: the enigma unraveled.

    Directory of Open Access Journals (Sweden)

    Vartika Saxena

    2016-03-01

    Full Text Available The search for new treatments and testing of new ideas begins in the laboratory and then established in clinical research settings. Studies addressing the same therapeutic problem may produce conflicting results hence Randomised Clinical Trial is regarded as the most valid method for assessing the benefits and harms of healthcare interventions. The next challenge face by the medical community is the validity of such trials as theses tend to deviate from the truth because of various biases. For the avoidance of the same it has been suggested that the validity or quality of primary trials should be assessed under blind conditions. Thus blinding, is a crucial method for reducing bias in randomized clinical trials. Blinding can be defined as withholding information about the assigned interventions from people involved in the trial who may potentially be prejudiced by this knowledge. In this article we make an effort to define blinding, explain its chronology, hierarchy and discuss methods of blinding, its assessment, its possibility, un-blinding and finally the latest guidelines.

  5. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Keeling Sally

    2008-05-01

    Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640

  6. Reporting of positive results in randomized controlled trials of mindfulness-based mental health interventions

    NARCIS (Netherlands)

    Coronado-Montoya, S.; Levis, A.W.; Kwakkenbos, C.M.C.; Steele, R.J.; Turner, E.H.; Thombs, B.D.

    2016-01-01

    Background A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-bas

  7. 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 t

  8. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial.

    LENUS (Irish Health Repository)

    Carney, John

    2010-10-01

    The transversus abdominis plane (TAP) block provides effective postoperative analgesia in adults undergoing major abdominal surgery. Its efficacy in children remains unclear, with no randomized clinical trials in this population. In this study, we evaluated its analgesic efficacy over the first 48 postoperative hours after appendectomy performed through an open abdominal incision, in a randomized, controlled, double-blind clinical trial.

  9. Effects of Pre-Trial Response Requirements on Self-Control Choices by Rats and Pigeons

    Science.gov (United States)

    Mazur, James E.

    2012-01-01

    Parallel experiments with rats and pigeons examined whether the size of a pre-trial ratio requirement would affect choices in a self-control situation. In different conditions, either 1 response or 40 responses were required before each trial. In the first half of each experiment, an adjusting-ratio schedule was used, in which subjects could…

  10. Survey and Practice of Reporting Quality of Randomized Controlled Clinical Trials on Traditional Chinese Medicine

    Institute of Scientific and Technical Information of China (English)

    LI Ting-qian; MAO Bing; WANG Gang; CHANG Jing; WANG Lei

    2008-01-01

    @@ Evidence obtained from randomized controlled trials (RCTs) has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully understand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner.

  11. Trial History Effects in Stroop Task Performance Are Independent of Top-Down Control

    NARCIS (Netherlands)

    Lorist, Monicque M.; Jolij, Jacob

    2012-01-01

    In this study we sought to elucidate what mechanisms underlie the effects of trial history on information processing. We explicitly focused on the contribution of conflict control and S-R binding to sequential trial effects. Performance and brain activity were measured during two hours of continuous

  12. Covariate Adjustment Strategy Increases Power in the Randomized Controlled Trial With Discrete-Time Survival Endpoints

    Science.gov (United States)

    Safarkhani, Maryam; Moerbeek, Mirjam

    2013-01-01

    In a randomized controlled trial, a decision needs to be made about the total number of subjects for adequate statistical power. One way to increase the power of a trial is by including a predictive covariate in the model. In this article, the effects of various covariate adjustment strategies on increasing the power is studied for discrete-time…

  13. The Paracetamol (Acetaminophen) In Stroke (PAIS) trial : a multicentre, randomised, placebo-controlled, phase III trial

    NARCIS (Netherlands)

    den Hertog, Heleen M.; van der Worp, H. Bart; van Gemert, H. Maarten A.; Algra, Ate; Kappelle, L. Jaap; Van Gijn, Jan; Koudstaal, Peter J.; Dippel, Diederik W. J.

    2009-01-01

    Background High body temperature in the first 12-24 h after stroke onset is associated with poor functional outcome. The Paracetamol (Acetaminophen) In Stroke (PAIS) trial aimed to assess whether early treatment with paracetamol improves functional outcome in patients with acute stroke by reducing b

  14. Non-random mate choice in humans: insights from a genome scan.

    Science.gov (United States)

    Laurent, R; Toupance, B; Chaix, R

    2012-02-01

    Little is known about the genetic factors influencing mate choice in humans. Still, there is evidence for non-random mate choice with respect to physical traits. In addition, some studies suggest that the Major Histocompatibility Complex may affect pair formation. Nowadays, the availability of high density genomic data sets gives the opportunity to scan the genome for signatures of non-random mate choice without prior assumptions on which genes may be involved, while taking into account socio-demographic factors. Here, we performed a genome scan to detect extreme patterns of similarity or dissimilarity among spouses throughout the genome in three populations of African, European American, and Mexican origins from the HapMap 3 database. Our analyses identified genes and biological functions that may affect pair formation in humans, including genes involved in skin appearance, morphogenesis, immunity and behaviour. We found little overlap between the three populations, suggesting that the biological functions potentially influencing mate choice are population specific, in other words are culturally driven. Moreover, whenever the same functional category of genes showed a significant signal in two populations, different genes were actually involved, which suggests the possibility of evolutionary convergences.

  15. The talking card: Randomized controlled trial of a novel audio-recording tool for asthma control.

    Science.gov (United States)

    Cowden, John D; Wilkerson-Amendell, Sharon; Weathers, Laura; Gonzalez, Emma D; Dinakar, Chitra; Westbrook, David H; Williams, Arthur R

    2015-01-01

    Asthma care plans typically include complicated written instructions. Customized, audio-recorded instructions may bridge health literacy gaps and improve treatment plan understanding. To measure the effects of a recordable greeting card-style tool (Talking Card) on asthma control and parental care of children with asthma. Multisite randomized trial in two primary care clinics, including children 4-11 years old with uncontrolled asthma and their parents. Parent-child dyads were randomized to usual care of asthma or usual care plus the Talking Card. Dyads completed three asthma-focused visits over 3 months. At the visit, card recipients received customized instructions recorded by the pediatrician onto an audio chip in the card. Asthma control was measured by using the Childhood Asthma Control Test. Card use and parental satisfaction were measured by parental survey (card arm only). Outcomes were analyzed by using generalized estimating equations and frequency distributions. Sixty-four dyads participated and attended 166 clinic visits. Card use was associated with a 1.6-point increase in Childhood Asthma Control Test score (p = 0.02) and a clinic visit regardless of card use with a three-point increase (p asthma. The Talking Card, a novel audio communication tool, was associated with improved asthma control and deemed highly desirable by parents and children struggling to control asthma. This inexpensive portable tool may be useful in other chronic disorders and in locales with low literacy and poor access to digital technology.

  16. Feldenkrais Method Balance Classes Improve Balance in Older Adults: A Controlled Trial

    Directory of Open Access Journals (Sweden)

    Karol A. Connors

    2011-01-01

    Full Text Available The objective of this study was to investigate the effects of Feldenkrais Method balance classes on balance and mobility in older adults. This was a prospective non-randomized controlled study with pre/post measures. The setting for this study was the general community. A convenience sample of 26 community-dwelling older adults (median age 75 years attending Feldenkrais Method balance classes formed the Intervention group. Thirty-seven volunteers were recruited for the Control group (median age 76.5 years. A series of Feldenkrais Method balance classes (the 33312Getting Grounded Gracefully33313 series, two classes per week for 10 weeks, were conducted. Main outcome measures were Activities-Specific Balance Confidence (ABC questionnaire, Four Square Step Test (FSST, self-selected gait speed (using GAITRite instrumented gait mat. At re-testing, the Intervention group showed significant improvement on all of the measures (ABC, P = .016, FSST, P = .001, gait speed, P < .001. The Control group improved significantly on one measure (FSST, P < .001. Compared to the Control group, the Intervention group made a significant improvement in their ABC score (P = .005, gait speed (P = .017 and FSST time (P = .022. These findings suggest that Feldenkrais Method balance classes may improve mobility and balance in older adults.

  17. Beyond Randomized Controlled Trials in Attempted Suicide Research

    Science.gov (United States)

    Hatcher, Simon; Sharon, Cynthia; Coggan, Carol

    2009-01-01

    There is a lack of evidence about what is the best treatment for people who present to hospital after self harm. Most treatment trials have been small and involved unrepresentative groups of patients which result in inconclusive findings. Here we note some of the characteristics of attempted suicide which make it a difficult subject to study. We…

  18. Beyond Randomized Controlled Trials in Attempted Suicide Research

    Science.gov (United States)

    Hatcher, Simon; Sharon, Cynthia; Coggan, Carol

    2009-01-01

    There is a lack of evidence about what is the best treatment for people who present to hospital after self harm. Most treatment trials have been small and involved unrepresentative groups of patients which result in inconclusive findings. Here we note some of the characteristics of attempted suicide which make it a difficult subject to study. We…

  19. Randomized controlled trials in frontotemporal dementia: cognitive and behavioral outcomes

    OpenAIRE

    Justin B. Miller; Banks, Sarah J.; Léger, Gabriel C; Cummings, Jeffrey L.

    2014-01-01

    Progress has been made in understanding the genetics and molecular biology of frontotemporal dementia (FTD). Targets for intervention have been identified, therapies are being developed, and clinical trials are advancing. A major challenge for FTD research is that multiple underlying pathologies can be associated with heterogeneous phenotypes. The neuropsychological profiles associated with FTD spectrum disorders often include executive dysfunction, language impairments and behavioral disturb...

  20. Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Silcock Jonathan

    2011-07-01

    Full Text Available Abstract Background The participant information sheet (PIS provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets - determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16. Methods In the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total - with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts. Results The first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p p Conclusions The original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet. User testing is an efficient method for indicating strengths and weaknesses in

  1. Randomised controlled trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection) trial.

    Science.gov (United States)

    Oakeshott, Pippa; Kerry, Sally; Aghaizu, Adamma; Atherton, Helen; Hay, Sima; Taylor-Robinson, David; Simms, Ian; Hay, Phillip

    2010-04-08

    To determine whether screening and treating women for chlamydial infection reduces the incidence of pelvic inflammatory disease over the subsequent 12 months. Randomised controlled trial. Common rooms, lecture theatres, and student bars at universities and further education colleges in London. 2529 sexually active female students, mean age 21 years (range 16-27). Participants completed a questionnaire and provided self taken vaginal swabs, with follow-up after one year. Samples were randomly allocated to immediate testing and treatment for chlamydial infection, or storage and analysis after a year (deferred screening controls). Incidence of clinical pelvic inflammatory disease over 12 months. Baseline prevalence of chlamydia was 5.4% (68/1254) in screened women and 5.9% (75/1265) in controls. 94% (2377/2529) of women were followed up after 12 months. The incidence of pelvic inflammatory disease was 1.3% (15/1191) in screened women compared with 1.9% (23/1186) in controls (relative risk 0.65, 95% confidence interval 0.34 to 1.22). Seven of 74 control women (9.5%, 95% confidence interval 4.7% to 18.3%) who tested positive for chlamydial infection at baseline developed pelvic inflammatory disease over 12 months compared with one of 63 (1.6%) screened women (relative risk 0.17, 0.03 to 1.01). However, most episodes of pelvic inflammatory disease occurred in women who tested negative for chlamydia at baseline (79%, 30/38). 22% (527/2377) of women reported being tested independently for chlamydia during the trial. Although some evidence suggests that screening for chlamydia reduces rates of pelvic inflammatory disease, especially in women with chlamydial infection at baseline, the effectiveness of a single chlamydia test in preventing pelvic inflammatory disease over 12 months may have been overestimated. Trial registration ClinicalTrials.gov NCT00115388.

  2. Randomized controlled trials in relapsed/refractory follicular lymphoma: a systematic review and meta-analysis.

    Science.gov (United States)

    Police, Rachel L; Trask, Peter C; Wang, Jianmin; Olivares, Robert; Khan, Shahnaz; Abbe, Adeline; Colosia, Ann; Njue, Annete; Sherril, Beth; Ruiz-Soto, Rodrigo; Kaye, James A; Hamadani, Mehdi

    2016-10-01

    This systematic literature review evaluated the clinical efficacy and safety of interventions used in relapsed/refractory follicular lymphoma. Primary efficacy outcomes were objective response rate, progression-free survival and overall survival. Safety endpoints were grade 3/4 toxicities, serious adverse events and withdrawals or deaths due to toxicity. Studies were selected if they were randomized controlled trials reporting on the efficacy or safety of treatments for relapsed or refractory follicular lymphoma, and if outcomes were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 10 randomized controlled trials of treatments for relapsed/refractory follicular lymphoma. The most prominent drug investigated (alone or in combination) was rituximab. Most trials did not report median overall survival. Two trials reported median event-free survival (range, 1.2-23.2 months). Six of ten trials reported objective response rate (range, 9-93%). Meta-analysis showed only one statistically significant result: rituximab + bortezomib yielded a significantly higher objective response rate than rituximab monotherapy (relative risk, 1.28; 95% confidence interval, 1.11-1.47). Otherwise, there were no discernable differences in overall survival or progression-free survival, partly due to insufficient reporting of results in the clinical trials. The relatively small number of randomized controlled trials, few overlapping treatment arms, and variability in the randomized controlled trial features and in the endpoints studied complicate the formal comparison of therapies for relapsed/refractory follicular lymphoma. Additional well-designed randomized controlled trials are needed to fully understand the relative outcomes of older and more recently developed therapies.

  3. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Evelim L F D Gomes

    Full Text Available The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma.A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20 or a treadmill group (TG; n = 16. Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO, maximum exercise testing (Bruce protocol and lung function.No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05. Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG.The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

  4. International collaborative trials, placebo controls and The Declaration of Helsinki: need for clarification in paragraph 32.

    Science.gov (United States)

    Malik, A Y; Ghafoor, F

    2012-01-01

    Inequities in socio-economic and healthcare systems between developed and developing countries have been thrown into sharp relief by globalisation. At the same time, pharmaceutical companies have started conducting clinical trials in developing countries in order to reduce their costs substantially. Together, these two developments create ethical challenges for sponsors and researchers of these trials. One such challenge is that of placebo-controlled trials (PCTs). In this paper we analyse Paragraph 32 of the Declaration of Helsinki referring to PCTs, identifying ambiguities in the wording, and then examine three arguments presented by sponsors of PCTs in developing countries, in defence of such trials. These arguments are: (i) a placebo control provides a definitive answer, and is therefore methodologically superior; (ii) placebo-controlled trials are ethical because they serve the principle of utility, and (iii) interpreting the "best current proven intervention" as the local standard of care allows PCTs to be conducted, if the local standard of care is "no treatment". We argue that PCTs are not methodologically superior; nor are they ethically defensible. Other trial designs conforming to the ethics of research are feasible; the reason for conducting PCTs is expediency. We further propose that, given the global applicability of the Declaration of Helsinki, it is imperative to remove the ambiguities in Paragraph 32. In the context of collaborative trials, when a treatment exists, conducting PCTs is ethically unacceptable, irrespective of the geographic location of the trial. Universal standards ought to be applied universally.

  5. Using Guasha to treat musculoskeletal pain: A systematic review of controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Choi Sun-Mi

    2010-01-01

    Full Text Available Abstract Background Guasha is a therapeutic method for pain management using tools to scrape or rub the surface of the body to relieve blood stagnation. This study aims to systematically review the controlled clinical trials on the effectiveness of using Guasha to treat musculoskeletal pain. Methods We searched 11 databases (without language restrictions: MEDLINE, Allied and Complementary Medicine (AMED, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL, Korean Studies Information (KSI, DBPIA, Korea Institute of Science and Technology Information (KISTI, KoreaMed, Research Information Service System (RISS, China National Knowledge Infrastructure (CNKI and the Cochrane Library. The search strategy was Guasha (OR scraping AND pain. Risk of bias was assessed with the Cochrane criteria (i.e. sequence generation, blinding, incomplete outcome measures and allocation concealment. Results Five randomized controlled trials (RCTs and two controlled clinical trials (CCTs were included in the present study. Two RCTs compared Guasha with acupuncture in terms of effectiveness, while the other trials compared Guasha with no treatment (1 trial, acupuncture (4 trials, herbal injection (1 trial and massage or electric current therapy (1 trial. While two RCTs suggested favorable effects of Guasha on pain reduction and response rate, the quality of these RCTs was poor. One CCT reported beneficial effects of Guasha on musculoskeletal pain but had low methodological quality. Conclusion Current evidence is insufficient to show that Guasha is effective in pain management. Further RCTs are warranted and methodological quality should be improved.

  6. The Nordic Aortic Valve Intervention (NOTION trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Thyregod Hans Gustav

    2013-01-01

    Full Text Available Abstract Background Degenerative aortic valve (AV stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting. Methods/Design This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA (intervention group compared with SAVR (control group in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR. Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012. Discussion The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis. Trial registration ClinicalTrials.gov: NCT01057173

  7. 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

  8. Systematic care for caregivers of patients with dementia: a multicenter, cluster-randomized, controlled trial

    NARCIS (Netherlands)

    Spijker, A.; Wollersheim, H.C.H.; Teerenstra, S.; Graff, M.J.L.; Adang, E.M.M.; Verhey, F.; Vernooij-Dassen, M.J.F.J.

    2011-01-01

    OBJECTIVE: To evaluate the effectiveness of the Systematic Care Program for Dementia (SCPD) on patient institutionalization and to determine the predictors of institutionalization. DESIGN: Single-blind, multicenter, cluster-randomized, controlled trial. SETTING: Six community mental health services

  9. Screening and brief intervention targeting risky drinkers in Danish general practice - a pragmatic controlled trial

    DEFF Research Database (Denmark)

    Beich, A.; Gannik, D.; Saelan, H.;

    2007-01-01

    AIMS: Recommendations for routine alcohol screening and brief counselling intervention in primary health care rest on results from intervention efficacy studies. By conducting a pragmatic controlled trial (PCT), we aimed at evaluating the effectiveness of the WHO recommendations for screening...

  10. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease : randomised controlled trial

    NARCIS (Netherlands)

    van Nimwegen, Marlies; Speelman, Arlene D.; Overeem, Sebastiaan; van de Warrenburg, Bart P.; Smulders, Katrijn; Dontje, Manon L.; Borm, George F.; Backx, Frank J. G.; Bloem, Bastiaan R.; Munneke, Marten

    2013-01-01

    Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. Design Multicentre randomised controlled trial. Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). Parti

  11. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease : randomised controlled trial

    NARCIS (Netherlands)

    van Nimwegen, Marlies; Speelman, Arlene D.; Overeem, Sebastiaan; van de Warrenburg, Bart P.; Smulders, Katrijn; Dontje, Manon L.; Borm, George F.; Backx, Frank J. G.; Bloem, Bastiaan R.; Munneke, Marten

    2013-01-01

    Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. Design Multicentre randomised controlled trial. Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). Parti

  12. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of a

  13. [Effects of a stepwise approach to behavioural problems in dementia: a cluster randomised controlled trial

    NARCIS (Netherlands)

    Pieper, M.J.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.; Twisk, J.W.R.; Kovach, C.R.; Achterberg, W.P.

    2016-01-01

    OBJECTIVE: To investigate whether implementation of a stepwise multidisciplinary intervention ('STA OP!' ['STAND UP!']) is effective in reducing behavioural problems and depressive symptoms in nursing home residents with advanced dementia. DESIGN: Cluster randomised controlled trial. METHOD: We

  14. Representation of people with intellectual disabilities in randomised controlled trials on antipsychotic treatment for behavioural problems

    NARCIS (Netherlands)

    Scheifes, A.; Stolker, J.J.; Nijman, H.L.I.; Egberts, A.C.G.; Heerdink, E.R.

    2011-01-01

    Background Behavioural problems are common in people with intellectual disability (ID) and are often treated with antipsychotics. Aim To establish the frequency and characteristics of people with ID included in randomised controlled trials (RCTs) on antipsychotic treatment for behavioural problems

  15. Structured risk assessment and violence in acute psychiatric wards: randomised controlled trial

    National Research Council Canada - National Science Library

    Abderhalden, Christoph; Needham, Ian; Dassen, Theo; Halfens, Ruud; Haug, Hans-Joachim; Fischer, Joachim E

    2008-01-01

    .... To assess whether such risk assessments decrease the incidence of violence and coercion. A cluster randomised controlled trial was conducted with 14 acute psychiatric admission wards as the units of randomisation, including a preference arm...

  16. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial

    National Research Council Canada - National Science Library

    Steinan, Mette Kvisten; Krane-Gartiser, Karoline; Langsrud, Knut; Sand, Trond; Kallestad, Håvard; Morken, Gunnar

    2014-01-01

    .... In this randomized controlled trial, we wish to compare CBT-I and treatment as usual with treatment as usual alone to determine its effect in improving quality of sleep, stabilizing minor mood...

  17. Controlled clinical trial of selective decontamination for the treatment of severe acute pancreatitis

    NARCIS (Netherlands)

    E.J.T. Luiten (Ernest); W.C.J. Hop (Wim); J.F. Lange (Johan); H.A. Bruining (Hajo)

    1995-01-01

    textabstractOBJECTIVE: A randomized, controlled, multicenter trial was undertaken in 102 patients with objective evidence of severe acute pancreatitis to evaluate whether selective decontamination reduces mortality. SUMMARY BACKGROUND DATA: Secondary pancreatic infectio

  18. Augmented cognitive behavioral therapy for poststroke depressive symptoms: A randomized controlled trial

    NARCIS (Netherlands)

    Kootker, J.A.; Rasquin, S.M.C.; Lem, F.C.; Heugten, C.M. van; Fasotti, L.; Geurts, A.C.H.

    2017-01-01

    OBJECTIVE: To evaluate the effectiveness of individually tailored cognitive behavioral therapy (CBT) for reducing depressive symptoms with or without anxiety poststroke. DESIGN: Multicenter, assessor-blinded, randomized controlled trial. SETTING: Ambulatory rehabilitation setting. PARTICIPANTS:

  19. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    National Research Council Canada - National Science Library

    Pitchford, Nicola J

    2015-01-01

    .... This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi...

  20. Whole Animal Experiments Should Be More Like Human Randomized Controlled Trials

    OpenAIRE

    2013-01-01

    The quality of reporting of animal studies lags behind that of human randomized controlled trials but a series of additions to the ARRIVE guidelines will help ensure that the standards are comparable.

  1. Rizatriptan vs. ibuprofen in migraine: a randomised placebo-controlled trial

    OpenAIRE

    Misra, Usha Kant; Kalita, Jayantee; Yadav, Rama Kant

    2007-01-01

    The objective of this study was to compare the efficacy of rizatriptan and ibuprofen in migraine. The study was a randomised placebo-controlled trial in a tertiary care teaching hospital. Migraine patients with

  2. Supervised exercise therapy versus usual care for patellofemoral pain syndrome : an open label randomised controlled trial

    NARCIS (Netherlands)

    van Linschoten, R.; van Middelkoop, M.; Berger, M. Y.; Heintjes, E. M.; Verhaar, J. A. N.; Willemsen, S. P.; Koes, B. W.; Bierma-Zeinstra, S. M.

    2009-01-01

    Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants

  3. Supervised exercise therapy versus usual care for patellofemoral pain syndrome : an open label randomised controlled trial

    NARCIS (Netherlands)

    van Linschoten, R.; van Middelkoop, M.; Berger, M. Y.; Heintjes, E. M.; Verhaar, J. A. N.; Willemsen, S. P.; Koes, B. W.; Bierma-Zeinstra, S. M.

    2009-01-01

    Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants

  4. Augmented cognitive behavioral therapy for post stroke depressive symptoms : a randomized controlled trial

    NARCIS (Netherlands)

    Kootker, Joyce A; Rasquin, Sascha Mc; Lem, Frederik C; van Heugten, Caroline M; Fasotti, Luciano; Geurts, Alexander C

    2016-01-01

    OBJECTIVE: To evaluate the effectiveness of individually tailored cognitive behavioral therapy (CBT) for reducing depressive symptoms with or without anxiety post stroke. DESIGN: Multi-center, assessor-blinded, randomized controlled trial. SETTING: Six ambulatory rehabilitation settings in The Nethe

  5. Yoga for persistent fatigue in breast cancer survivors: a randomized controlled trial

    National Research Council Canada - National Science Library

    Bower, Julienne E; Garet, Deborah; Sternlieb, Beth; Ganz, Patricia A; Irwin, Michael R; Olmstead, Richard; Greendale, Gail

    2012-01-01

    .... The authors conducted a 2-group randomized controlled trial to determine the feasibility and efficacy of an Iyengar yoga intervention for breast cancer survivors with persistent post-treatment fatigue...

  6. Arthrocentesis as initial treatment for temporomandibular joint arthropathy : A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L. M.; Huddleston Slater, J. J. R.; Stegenga, B.

    2014-01-01

    Objective: To determine the effectiveness of arthrocentesis compared to conservative treatment as initial treatment with regard to temporomandibular joint pain and mandibular movement. Patients and methods: In this randomized controlled trial, 80 patients with arthralgia of the TMJ (classified accor

  7. Randomized controlled trial of the Pentax AWS, Glidescope, and Macintosh laryngoscopes in predicted difficult intubation.

    LENUS (Irish Health Repository)

    Malik, M A

    2009-11-01

    The purpose of this study was to determine the potential for the Pentax AWS and the Glidescope to reduce the difficulty of tracheal intubation in patients at increased risk for difficult tracheal intubation, in a randomized, controlled clinical trial.

  8. International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice.

    Science.gov (United States)

    2001-05-14

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E10 Choice of Control Group and Related Issues in Clinical Trials." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth general principles that are relevant to all controlled trials and are especially pertinent to the major clinical trials intended to demonstrate drug (including biological drug) efficacy. The guidance describes the principal types of control groups and discusses their appropriateness in particular situations. The guidance is intended to assist sponsors and investigators in the choice of control groups for clinical trials.

  9. Sodium Restriction in Patients With CKD : A Randomized Controlled Trial of Self-management Support

    NARCIS (Netherlands)

    Meuleman, Yvette; Hoekstra, Tiny; Dekker, Friedo W.; Navis, Gerjan; Vogt, Liffert; van der Boog, Paul J. M.; Bos, Willem Jan W.; van Montfrans, Gert A.; van Dijk, Sandra

    Background: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. Study Design: Open randomized controlled trial. Setting & Participants: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands.

  10. Controlled clinical trial of selective decontamination for the treatment of severe acute pancreatitis

    NARCIS (Netherlands)

    E.J.T. Luiten (Ernest); W.C.J. Hop (Wim); J.F. Lange (Johan); H.A. Bruining (Hajo)

    1995-01-01

    textabstractOBJECTIVE: A randomized, controlled, multicenter trial was undertaken in 102 patients with objective evidence of severe acute pancreatitis to evaluate whether selective decontamination reduces mortality. SUMMARY BACKGROUND DATA: Secondary pancreatic

  11. The challenge of recruiting patients into a placebo-controlled surgical trial

    DEFF Research Database (Denmark)

    Hare, Kristoffer B; Lohmander, L Stefan; Roos, Ewa M.

    2014-01-01

    patient into the RCT, 11.9 individuals needed to be screened. A total of 69% of participating patients considered the oral information to be the most important and the most common reason for participating was the contribution to research (90%). CONCLUSIONS: Patients are willing to participate...... in an orthopedic placebo-controlled surgical trial. Oral information given by the surgeon to the patient and the contribution to research are important aspects to enhance patient recruitment. TRIAL REGISTRATION: ClinicalTrials.gov NCT01264991, registered 21 December 2010....... component only adds to this complexity. The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial, to determine the number of patients needed to be screened and allocated in order to include one participant into the trial...

  12. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    OpenAIRE

    Young-Dae Kim; In Heo; Byung-Cheul Shin; Cindy Crawford; Hyung-Won Kang; Jung-Hwa Lim

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional th...

  13. Atrial Substrate Modification in Atrial Fibrillation: Targeting GP or CFAE? Evidence from Meta-Analysis of Clinical Trials

    OpenAIRE

    Qin, Mu; Liu, Xu; Wu, Shao-Hui; Zhang, Xiao-dong

    2016-01-01

    Several clinically relevant outcomes post atrial substrate modification in patients with atrial fibrillation (AF) have not been systematically analyzed among published studies on adjunctive cardiac ganglionated plexi (GP) or complex fractionated atrial electograms (CFAE) ablation vs. pulmonary vein isolation (PVI) alone. Out of 176 reports identified, the present meta-analysis included 14 randomized and non-randomized controlled trials (1613 patients) meeting inclusion criteria. Addition of G...

  14. Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial

    Directory of Open Access Journals (Sweden)

    Msika Simon

    2011-07-01

    Full Text Available Abstract Background Open transthoracic oesophagectomy is the standard treatment for infracarinal resectable oesophageal carcinomas, although it is associated with high mortality and morbidity rates of 2 to 10% and 30 to 50%, respectively, for both the abdominal and thoracic approaches. The worldwide popularity of laparoscopic techniques is based on promising results, including lower postoperative morbidity rates, which are related to the reduced postoperative trauma. We hypothesise that the laparoscopic abdominal approach (laparoscopic gastric mobilisation in oesophageal cancer surgery will decrease the major postoperative complication rate due to the reduced surgical trauma. Methods/Design The MIRO trial is an open, controlled, prospective, randomised multicentre phase III trial. Patients in study arm A will receive laparoscopic-assisted oesophagectomy, i.e., a transthoracic oesophagectomy with two-field lymphadenectomy and laparoscopic gastric mobilisation. Patients in study arm B will receive the same procedure, but with the conventional open abdominal approach. The primary objective of the study is to evaluate the major postoperative 30-day morbidity. Secondary objectives are to assess the overall 30-day morbidity, 30-day mortality, 30-day pulmonary morbidity, disease-free survival, overall survival as well as quality of life and to perform medico-economic analysis. A total of 200 patients will be enrolled, and two safety analyses will be performed using 25 and 50 patients included in arm A. Discussion Postoperative morbidity remains high after oesophageal cancer surgery, especially due to major pulmonary complications, which are responsible for 50% of the postoperative deaths. This study represents the first randomised controlled phase III trial to evaluate the benefits of the minimally invasive approach with respect to the postoperative course and oncological outcomes in oesophageal cancer surgery. Trial Registration NCT00937456 (ClinicalTrials.gov

  15. Comparison of Topical Nifedipine With Oral Nifedipine for Treatment of Anal Fissure: A Randomized Controlled Trial

    OpenAIRE

    Golfam, Farzaneh; Golfam, Parisa; Golfam, Babak; Pahlevani, Puyan

    2014-01-01

    Background: Medical sphincterotomy has gained popularity as a treatment for anal fissure. Calcium channel blockers in topical forms could also be appropriate with low adverse effects. Objectives: This was a prospective randomized controlled trial to compare topical and oral nifedipine in the treatment of chronic anal fissure. Patients and Methods: A prospective randomized controlled trial was conducted at two centers of Shahed University. One hundred and thirty patients with chronic anal fiss...

  16. Effect of prenatal DHA supplementation on the infant epigenome: results from a randomized controlled trial

    OpenAIRE

    van Dijk, Susan J.; Zhou, Jing; Peters, Timothy J; Buckley, Michael; Sutcliffe, Brodie; Oytam, Yalchin; Robert A Gibson; McPhee, Andrew; Yelland, Lisa N; Makrides, Maria; Molloy, Peter L.; Beverly S Muhlhausler

    2016-01-01

    Background Evidence is accumulating that nutritional exposures in utero can influence health outcomes in later life. Animal studies and human epidemiological studies have implicated epigenetic modifications as playing a key role in this process, but there are limited data from large well-controlled human intervention trials. This study utilized a large double-blind randomized placebo-controlled trial to test whether a defined nutritional exposure in utero, in this case docosahexaenoic acid (D...

  17. Effect of diclofenac suppository on pain control during flexible cystoscopy-A randomized controlled trial

    Science.gov (United States)

    Nadeem, Mehwash; Ather, M Hammad

    2016-01-01

    TRIAL DESIGN: To compare the difference in pain score during flexible cystoscopy between patients undergoing the procedure with plain lubricating gel  only and plain gel with diclofenac suppository in a randomized control trial. METHODS:  A total of 60 male patients with an indication of flexible cystoscopy were enrolled in a prospective, randomized controlled study. Patients were randomized in two groups. In group “A”, patients received diclofenac suppository one hour prior to the procedure while group “B” did not receive diclofenac suppository. Both groups received 10 ml of intra-urethral  plain gel for lubrication during flexible cystoscopy. Pain score was recorded immediately after the procedure using the visual analogue scale (VAS). Pre- and post-procedure pulse rate and systolic blood pressure was also recorded. Statistical analyses were performed using chi-square test and student t-test. Regression analysis was performed to address the confounding variables. RESULTS: Both groups were comparable for variables including age, duration of procedure, level of operating surgeon and indication of procedure. Most common indication for flexible cystoscopy was removal of double J stent. There was a statistically significant difference in the mean pain score between two groups ( p = 0.012).  The difference in post-procedure mean pulse rate in the two groups was statistically significant ( p= 0.01) however there was no difference observed in mean post procedure systolic blood pressure. Regression analysis showed that none of the confounding variables were significantly affecting pain perception. CONCLUSIONS: Intra rectal diclofenac suppository is simple and effective pre-emptive analgesia. We recommend its routine use during flexible cystoscopy for better pain control. PMID:28299180

  18. Randomized controlled trials for Alzheimer disease and Parkinson disease.

    Science.gov (United States)

    Lauretani, Fulvio; Ticinesi, Andrea; Meschi, Tiziana; Teresi, Giulio; Ceda, Gian Paolo; Maggio, Marcello

    2016-06-01

    The continuous increase in elderly and oldest-old population, and subsequent rise in prevalence of chronic neurological diseases like Alzheimer's disease (AD) and Parkinson's disease (PD), are a major challenge for healthcare systems. These two conditions are the most prevalent neurodegenerative diseases in older persons and physicians should engage treatment for these patients. In this field, Randomized Clinical Trials (RCTs) specifically focused on elderly populations are still lacking. The aim of this study was to identify RCTs conducted among AD and PD and to examine the difference between mean age of enrollment and incidence of these two neurodegenerative diseases. We found that the scenario is different between PD and AD. In particular, the enrollment for PD trials seems to include younger persons than AD, although the incidence of both diseases is similar and highest after 80 years old. The consequence of these results could influence conclusive guidelines of treatment in older parkinsonian patients.

  19. A controlled trial of amitriptyline and cianopramine in major depression.

    Science.gov (United States)

    Mellsop, G W; Burgess, C D; Vijayasenan, M E

    1985-01-01

    The therapeutic efficacy and adverse effects of amitriptyline and cianopramine were compared in a double-blind, randomized, flexible-dose trial in 40 patients with major depressive episodes. The two drugs were equally effective in reducing scores on the Hamilton Psychiatric Rating Scale for Depression and on a global scale. Both drugs were associated with significant adverse effects. Fewer adverse effects were associated with cianopramine, however, which lacks antimuscarinic activity.

  20. Statin tolerability: In defence of placebo-controlled trials

    OpenAIRE

    Tobert, Jonathan A; Newman, Connie B.

    2015-01-01

    Background Statin intolerance is a barrier to effective lipid-lowering treatment. A significant number of patients stop prescribed statins, or can take only a reduced dose, because of adverse events attributed to the statin, and are then considered statin-intolerant. Methods Examination of differences between statin and placebo in withdrawal rates due to adverse events – a good measure of tolerability – in statin cardiovascular outcome trials in patients with advanced disease and complex medi...

  1. Targeting intensive versus conventional glycaemic control for type 1 diabetes mellitus: a systematic review with meta-analyses and trial sequential analyses of randomised clinical trials

    OpenAIRE

    Kähler, Pernille; Grevstad, Berit; Almdal, Thomas; Gluud, Christian; Wetterslev, Jørn; Vaag, Allan; Hemmingsen, Bianca

    2014-01-01

    Objective To assess the benefits and harms of targeting intensive versus conventional glycaemic control in patients with type 1 diabetes mellitus. Design A systematic review with meta-analyses and trial sequential analyses of randomised clinical trials. Data sources The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded and LILACS to January 2013. Study selection Randomised clinical trials that prespecified different targets of glycaemic control in participants at any age with...

  2. Mindfulness Meditation Training and Executive Control Network Resting State Functional Connectivity: A Randomized Controlled Trial.

    Science.gov (United States)

    Taren, Adrienne A; Gianaros, Peter J; Greco, Carol M; Lindsay, Emily K; Fairgrieve, April; Brown, Kirk Warren; Rosen, Rhonda K; Ferris, Jennifer L; Julson, Erica; Marsland, Anna L; Creswell, J David

    Mindfulness meditation training has been previously shown to enhance behavioral measures of executive control (e.g., attention, working memory, cognitive control), but the neural mechanisms underlying these improvements are largely unknown. Here, we test whether mindfulness training interventions foster executive control by strengthening functional connections between dorsolateral prefrontal cortex (dlPFC)-a hub of the executive control network-and frontoparietal regions that coordinate executive function. Thirty-five adults with elevated levels of psychological distress participated in a 3-day randomized controlled trial of intensive mindfulness meditation or relaxation training. Participants completed a resting state functional magnetic resonance imaging scan before and after the intervention. We tested whether mindfulness meditation training increased resting state functional connectivity (rsFC) between dlPFC and frontoparietal control network regions. Left dlPFC showed increased connectivity to the right inferior frontal gyrus (T = 3.74), right middle frontal gyrus (MFG) (T = 3.98), right supplementary eye field (T = 4.29), right parietal cortex (T = 4.44), and left middle temporal gyrus (T = 3.97, all p < .05) after mindfulness training relative to the relaxation control. Right dlPFC showed increased connectivity to right MFG (T = 4.97, p < .05). We report that mindfulness training increases rsFC between dlPFC and dorsal network (superior parietal lobule, supplementary eye field, MFG) and ventral network (right IFG, middle temporal/angular gyrus) regions. These findings extend previous work showing increased functional connectivity among brain regions associated with executive function during active meditation by identifying specific neural circuits in which rsFC is enhanced by a mindfulness intervention in individuals with high levels of psychological distress. Clinicaltrials.gov,NCT01628809.

  3. 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

  4. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Liv M

    2012-07-01

    Full Text Available Abstract Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity, mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost

  5. Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial

    Directory of Open Access Journals (Sweden)

    Bou Christophe

    2009-08-01

    Full Text Available Abstract Background Periodontitis is a common, chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients. However current evidence does not provide sufficient information on which to confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis. Methods The DIAPERIO trial is an open-label, 13-week follow-up, randomized, controlled trial. The total target sample size is planned at 150 participants, with a balanced (1:1 treatment allocation (immediate treatment vs delayed treatment. Periodontal treatment will include full mouth non-surgical scaling and root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12% and oral health instructions. The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups. Discussion The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies. Trial registration Current Controlled Trials ISRCTN15334496

  6. How do parents experience being asked to enter a child in a randomised controlled trial?

    Directory of Open Access Journals (Sweden)

    Young Bridget

    2009-02-01

    Full Text Available Abstract Background As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Discussion Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Summary Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future

  7. 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

  8. Non-random food-web assembly at habitat edges increases connectivity and functional redundancy.

    Science.gov (United States)

    Peralta, Guadalupe; Frost, Carol M; Didham, Raphael K; Rand, Tatyana A; Tylianakis, Jason M

    2017-04-01

    Habitat fragmentation dramatically alters the spatial configuration of landscapes, with the creation of artificial edges affecting community structure and dynamics. Despite this, it is not known how the different food webs in adjacent habitats assemble at their boundaries. Here we demonstrate that the composition and structure of herbivore-parasitoid food webs across edges between native and plantation forests are not randomly assembled from those of the adjacent communities. Rather, elevated proportions of abundant, interaction-generalist parasitoid species at habitat edges allowed considerable interaction rewiring, which led to higher linkage density and less modular networks, with higher parasitoid functional redundancy. This was despite high overlap in host composition between edges and interiors. We also provide testable hypotheses for how food webs may assemble between habitats with lower species overlap. In an increasingly fragmented world, non-random assembly of food webs at edges may increasingly affect community dynamics at the landscape level.

  9. A psycho-educational HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: results from a non-randomized cohort pilot study.

    Directory of Open Access Journals (Sweden)

    Carmen H Logie

    Full Text Available BACKGROUND: Little evidence exists regarding efficacious HIV and sexually transmitted infections (STI prevention interventions with internally displaced populations. Internally displaced women are at elevated risk for HIV/STI due to limited access to health services, heightened poverty and social network breakdown. The FASY (Famn an Aksyon Pou Sante' Yo (Women Taking Action For Their Health study examined the effectiveness of a peer health worker (PHW delivered psycho-educational HIV/STI pilot study with internally displaced women in Leogane, Haiti. METHOD: This was a non-randomized cohort pilot study. Participants completed a computer-assisted pre-test programmed on Android tablet PCs followed by an HIV/STI educational video-based session and a 6-week psycho-educational group program of weekly meetings. Participants completed a post-test upon completion of group sessions. The primary outcome was HIV knowledge; our pre-specified index of clinically significant change was an effect size of 0.30. Secondary outcomes included: STI knowledge, condom use, social support, resilient coping, depression and relationship control. We used mixed-effects regression to calculate mean outcome pre-post score change. This study was registered (clinicaltrials.gov, NCT01492829. RESULTS: Between January 1-April 30, 2012 we assigned 200 participants to the study. The majority of participants (n = 176, 88% completed the study and were followed up at 8 weeks, finishing April 30, 2012. Adjusted for socio-demographic characteristics, HIV knowledge (β = 4.81; 95% CI 4.36-5.26, STI knowledge (β = 0.84; 95% CI 0.70-0.99, condom use (AOR = 4.05, 95% CI 1.86-8.83, and depression (β = -0.63, 95% CI -0.88--0.39 scores showed statistically significant change post-intervention (p<0.05. CONCLUSIONS: This pilot study evaluated a PHW psycho-educational HIV/STI prevention intervention among internally displaced women in post-earthquake Haiti. Pilot studies are an important

  10. WORKBENCH FOR CONTROL SYSTEMS TRIALS BASED ON VIPA 300 CONTROLLER AND ADVANTECH INPUT/OUTPUT CARD

    Directory of Open Access Journals (Sweden)

    M. V. Levinskyi

    2015-01-01

    Full Text Available The topic is about workbench creation for control systems trials based on VIPA 300 industrial PLC and model of control object which is implemented in MatLab Simulink program on PC. Connection between controller and the PC is provided by the Advantech PCI-1711 input/output card of discrete and analog signals. Object identification,control system synthesis, creation of control device structure and its parametrical identification, as a rule, is done on a PC in a modelling environment, e.g. in MatLab. But often, using this PC modelling, the hardware and software features of algorithms which were obtained during system synthesis are not considered in a specific industrial PLC.It is considered a good idea to use a composite version where obtained algorithms are tested in a real industrial PLC and control object is substituted by a model which is working on a PC in real time scale. In this case software realization of algorithms in a specific PLC are fully taken into account and substitution of real control object by itsmodel considerably reduces the costs for carrying out experiments and allows to study the system behavior when control object parameters and modes of operation vary greatly. The creation of workbench stipulates several stages: configuration and programming of industrial PLC VIPA 313 SC, installation and configuration of Advantech PCI- 1711 input/output card, tuning of Simulink modelling environment for working in real time scale using Real-Time Windows Target Library, testing of workbench by using constant and harmonic signals of different frequencies. Work results of virtual stabilization system are compared with combined version. In virtual stabilization system PID governor and control object are implemented in Simulink. In combined version control object is still implemented in Simulink and PID governor - in VIPA 313 SC controller (using functional block FB58 from Step7 standard library.

  11. A randomized controlled trial of Human Papillomavirus (HPV testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial

    Directory of Open Access Journals (Sweden)

    Smith Laurie W

    2010-03-01

    Full Text Available Abstract Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5% were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%. In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%. Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

  12. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery.

    Science.gov (United States)

    Healy, D A; Boyle, E; McCartan, D; Bourke, M; Medani, M; Ferguson, J; Yagoub, H; Bashar, K; O'Donnell, M; Newell, J; Canning, C; McMonagle, M; Dowdall, J; Cross, S; O'Daly, S; Manning, B; Fulton, G; Kavanagh, E G; Burke, P; Grace, P A; Moloney, M Clarke; Walsh, S R

    2015-11-01

    A pilot randomized controlled trial that evaluated the effect of remote ischemic preconditioning (RIPC) on clinical outcomes following major vascular surgery was performed. Eligible patients were those scheduled to undergo open abdominal aortic aneurysm repair, endovascular aortic aneurysm repair, carotid endarterectomy, and lower limb revascularization procedures. Patients were randomized to RIPC or to control groups. The primary outcome was a composite clinical end point comprising any of cardiovascular death, myocardial infarction, new-onset arrhythmia, cardiac arrest, congestive cardiac failure, cerebrovascular accident, renal failure requiring renal replacement therapy, mesenteric ischemia, and urgent cardiac revascularization. Secondary outcomes were components of the primary outcome and myocardial injury as assessed by serum troponin values. The primary outcome occurred in 19 (19.2%) of 99 controls and 14 (14.1%) of 99 RIPC group patients (P = .446). There were no significant differences in secondary outcomes. Our trial generated data that will guide future trials. Further trials are urgently needed. © The Author(s) 2015.

  13. Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Overgaard Hans J

    2012-10-01

    Full Text Available Abstract Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA; dengue interventions (DEN; combined diarrhea and dengue interventions (DIADEN; and control (C. Schools were allocated publicly in each municipality (strata at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de

  14. Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation

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

    Science.gov (United States)

    O'Cathain, Alicia; Hoddinott, Pat; Lewin, Simon; Thomas, Kate J; Young, Bridget; Adamson, Joy; Jansen, Yvonne Jfm; Mills, Nicola; Moore, Graham; Donovan, Jenny 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 trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.

  16. Headache : The placebo effects in the control groups in randomized clinical trials; An analysis of systematic reviews

    NARCIS (Netherlands)

    de Groot, Femke M.; Voogt-Bode, Annieke; Passchier, Jan; Berger, Marjolein Y.; Koes, Bart W.; Verhagen, Arianne P.

    Objective: The purpose of this study is to describe the effects in the placebo and "no treatment" arms in trials with headache patients. Method: This is a secondary analysis of randomized controlled trials from 8 systematic reviews and selected trials with a "no treatment" or placebo control group.

  17. Collaborative Depression Trial (CADET: multi-centre randomised controlled trial of collaborative care for depression - study protocol

    Directory of Open Access Journals (Sweden)

    Kessler David

    2009-10-01

    Full Text Available Abstract Background Comprising of both organisational and patient level components, collaborative care is a potentially powerful intervention for improving depression treatment in UK primary Care. However, as previous models have been developed and evaluated in the United States, it is necessary to establish the effect of collaborative care in the UK in order to determine whether this innovative treatment model can replicate benefits for patients outside the US. This Phase III trial was preceded by a Phase II patient level RCT, following the MRC Complex Intervention Framework. Methods/Design A multi-centre controlled trial with cluster-randomised allocation of GP practices. GP practices will be randomised to usual care control or to "collaborative care" - a combination of case manager coordinated support and brief psychological treatment, enhanced specialist and GP communication. The primary outcome will be symptoms of depression as assessed by the PHQ-9. Discussion If collaborative care is demonstrated to be effective we will have evidence to enable the NHS to substantially improve the organisation of depressed patients in primary care, and to assist primary care providers to deliver a model of enhanced depression care which is both effective and acceptable to patients. Trial Registration Number ISRCTN32829227

  18. Recommendations on multiple testing adjustment in multi-arm trials with a shared control group.

    Science.gov (United States)

    Howard, Dena R; Brown, Julia M; Todd, Susan; Gregory, Walter M

    2016-09-19

    Multi-arm clinical trials assessing multiple experimental treatments against a shared control group can offer efficiency advantages over independent trials through assessing an increased number of hypotheses. Published opinion is divided on the requirement for multiple testing adjustment to control the family-wise type-I error rate (FWER). The probability of a false positive error in multi-arm trials compared to equivalent independent trials is affected by the correlation between comparisons due to sharing control data. We demonstrate that this correlation in fact leads to a reduction in the FWER, therefore FWER adjustment is not recommended solely due to sharing control data. In contrast, the correlation increases the probability of multiple false positive outcomes across the hypotheses, although standard FWER adjustment methods do not control for this. A stringent critical value adjustment is proposed to maintain equivalent evidence of superiority in two correlated comparisons to that obtained within independent trials. FWER adjustment is only required if there is an increased chance of making a single claim of effectiveness by testing multiple hypotheses, not due to sharing control data. For competing experimental therapies, the correlation between comparisons can be advantageous as it eliminates bias due to the experimental therapies being compared to different control populations.

  19. Efficacy and tolerability of an ectoine mouth and throat spray compared with those of saline lozenges in the treatment of acute pharyngitis and/or laryngitis: a prospective, controlled, observational clinical trial.

    Science.gov (United States)

    Müller, Dörte; Lindemann, Torben; Shah-Hosseini, Kija; Scherner, Olaf; Knop, Markus; Bilstein, Andreas; Mösges, Ralph

    2016-09-01

    The aim of this observational trial was to evaluate the efficacy and tolerability of a mouth and throat spray containing ectoine in the treatment of acute pharyngitis and/or laryngitis. The outcome was compared with control treatment using saline lozenges. This study was designed as a prospective, controlled, non-randomized, observational multicenter clinical trial and was conducted in Germany. The study population consisted of 95 patients. The decision for treatment with either spray or lozenges was based on the patients' preference for pharyngeal or oral application. Investigators assessed symptoms specific to acute pharyngitis/laryngitis and determined the pharyngitis symptom score. Both patients and investigators evaluated the tolerability and efficacy of the treatment applied. Treatment with the spray showed higher efficacy, 1.95 ± 0.81 versus 1.68 ± 0.67 (investigators) and 1.97 ± 0.88 versus 1.57 ± 0.69 (patients, p ectoine-based spray showed superior efficacy in treating acute pharyngitis and/or laryngitis.

  20. Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution

    Directory of Open Access Journals (Sweden)

    Ian Relf

    2008-01-01

    Full Text Available Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection.

  1. The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study)

    Science.gov (United States)

    von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E.; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Helewa, Michael; Hutton, Eileen; Koren, Gideon; Lee, Shoo K.; Logan, Alexander G.; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G.; Moutquin, Jean-Marie

    2016-01-01

    To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of “less tight” (target diastolic blood pressure [dBP] 100 mm Hg) versus “tight” control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×109/L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission (P=0.20): CHIPS primary outcome, birth weight <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×109/L (P=0.006), and prolonged hospital stay (P=0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control (P=0.02). Adjustment for preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), or elevated liver enzymes with symptoms (P=0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preeclampsia co-occurrence. Clinical Trial Registration— URL: http://pre-empt.cfri.ca/. Unique identifier: ISRCTN

  2. The RESPITE trial: remifentanil intravenously administered patient-controlled analgesia (PCA) versus pethidine intramuscular injection for pain relief in labour: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Wilson, Matthew; MacArthur, Christine; Gao Smith, Fang; Homer, Leanne; Handley, Kelly; Daniels, Jane

    2016-12-12

    The commonest opioid used for pain relief in labour is pethidine (meperidine); however, its effectiveness has long been challenged and the drug has known side effects including maternal sedation, nausea and potential transfer across the placenta to the foetus. Over a third of women receiving pethidine require an epidural due to inadequate pain relief. Epidural analgesia increases the risk of an instrumental vaginal delivery and its associated effects. Therefore, there is a clear need for a safe, effective, alternative analgesic to pethidine. Evidence suggests that remifentanil patient-controlled analgesia (PCA) reduces epidural conversion rates compared to pethidine; however, no trial has yet investigated this as a primary endpoint. We are, therefore, comparing pethidine intramuscular injection to remifentanil PCA in a randomised controlled trial. Women in established labour, requesting systemic opioid pain relief, will be randomised to either intravenously administered remifentanil PCA (intervention) or pethidine intramuscular injection (control) in an unblinded, 1:1 individual randomised trial. Following informed consent, 400 women in established labour, who request systemic opioid pain relief, from NHS Trusts across England will undergo a minimised randomisation by a computer or automated telephone system to either pethidine or remifentanil. In order to balance the groups this minimisation is based on four parameters; parity (nulliparous versus multiparous), maternal age (relief provided by each technique will be recorded every 30 min after time zero, until epidural placement, delivery or transfer to theatre, quantified by Visual Analogue Scale. Incidence of maternal side effects including sedation, delivery mode, foetal distress requiring delivery, neonatal status at delivery and rate of initiation of breastfeeding within the first hour of birth will also be recorded. Maternal satisfaction with her childbirth experience will be determined by a postpartum

  3. The FIB-PPH trial: fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wikkelsoe Anne

    2012-07-01

    Full Text Available Abstract Background Postpartum haemorrhage (PPH remains a leading cause of maternal mortality worldwide. In Denmark 2% of parturients receive blood transfusion. During the course of bleeding fibrinogen (coagulation factor I may be depleted and fall to critically low levels, impairing haemostasis and thus worsening the ongoing bleeding. A plasma level of fibrinogen below 2 g/L in the early phase of postpartum haemorrhage is associated with subsequent development of severe haemorrhage. Use of fibrinogen concentrate allows high-dose substitution without the need for blood type crossmatch. So far no publications of randomised controlled trials involving acutely bleeding patients in the obstetrical setting have been published. This trial aims to investigate if early treatment with fibrinogen concentrate reduces the need for blood transfusion in women suffering severe PPH. Methods/Design In this randomised placebo-controlled double-blind multicentre trial, parturients with primary PPH are eligible following vaginal delivery in case of: manual removal of placenta (blood loss ≥ 500 ml or manual exploration of the uterus after the birth of placenta (blood loss ≥ 1000 ml. Caesarean sections are also eligible in case of perioperative blood loss ≥ 1000 ml. The exclusion criteria are known inherited haemostatic deficiencies, prepartum treatment with antithrombotics, pre-pregnancy weight Primary outcome is the need for blood transfusion. To investigate a 33% reduction in the need for blood transfusion, a total of 245 patients will be included. Four university-affiliated public tertiary care hospitals will include patients during a two-year period. Adverse events including thrombosis are assessed in accordance with International Conference on Harmonisation (ICH good clinical practice (GCP. Discussion A widespread belief in the benefits of early fibrinogen substitution in cases of PPH has led to increased off-label use. The FIB

  4. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

    Science.gov (United States)

    Chmiel, Corinne; Senn, Oliver; Rosemann, Thomas; Del Prete, Valerio; Steurer-Stey, Claudia

    2014-01-01

    Background Inadequate blood pressure (BP) control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP) improves BP control and adherence with home BP measurement. Methods In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg), and adherence with home BP measurement after 6 months. Results One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7). BP control (treatment target <140/90 mmHg) was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5). Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1) Conclusion Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months), but no significant between-group difference was observed in BP change. A markedly higher percentage of patients achieved BP values in the normal range. This simple, inexpensive approach of color-coded BP self-monitoring is user-friendly and applicable in primary care

  5. Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

    Science.gov (United States)

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

    Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

  6. Fluoxetine for poststroke depression A randomized placebo controlled clinical trial

    Institute of Scientific and Technical Information of China (English)

    Yan Kong; Wanli Dong; Chunfeng Liu

    2007-01-01

    BACKGROUND: Studies have demonstrated that poststroke depression(PSD) may be related with the disequilibrium between noradrenaline and 5-hydroxytryptamine (5-HT) caused by cerebral injury. The injured regions involve noradrenergic and 5-hydroxytryptaminergic neurons as well as conduction pathway.The levels of noradrenaline and 5-HT would be decreased.OBJECTIVE: To observe the effect of fluoxetine on preventing against PSD and recovery of neurologic function, and analyze the relationship of fluoxetine and the 5-HT level.DESIGN: A randomized controlled clinical trial.SETTING: Department of Neurology, First Hospital Affiliated to Soochow University.PARTICIPANTS: Ninety consecutive patients, 47 female and 43 male, were recruited who admitted to hospital for recent stroke in the Department of Neurology, First Affiliated Hospital of Soochow University between September 2003 and February 2005. Subjects were aged (64±7) years, ranging from 47 to 79 years old. They all met the diagnosis criteria of various cerebrovascular diseases formulated in the 4th National Cerebrovascular Disease Conference and confirmed as stroke by skull CT or MRI; The time from onset to tentative administration was less than 7 days; The patients had clear consciousness, without obvious language disorder. They were randomized into treatment group (n =48) and placebo group (n =42).METHODS: ①All the patients were given routine treatment according to treatment guideline of cerebrovascular disease after admission. Patients in the treatment group and placebo group received 20 mg/d fluoxetine and placebo (component: vitamin C) for 8 weeks, respectively. ② Neurologic deficit was assessed according to 24-item Hamilton Rating Scale for Depression (HAMD) and Activity of Daily Living Scale (ADL) before and at 2,4 and 8 weeks after test, separately; Meanwhile, the levels of platelet 5-HT and plasma 5-HT were determined. Grading criteria of HAMD intergral depression: non-depression < 8 points

  7. 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

  8. Evaluation of a community-based randomized controlled prenatal care trial in rural China.

    Science.gov (United States)

    Wu, Zhuochun; Viisainen, Kirsi; Wang, Ying; Hemminki, Elina

    2011-05-04

    A community-based randomized control prenatal care trial was performed in a rural county of China during 2000-2003. The purpose of this paper is to describe the trial implementation and the impact of the trial on the utilization of prenatal care and perinatal outcomes. In the study county, 10 townships (from a total of 55) were each paired with a control (20 study townships in total), with the criteria for pairing being the township's socioeconomic development, perinatal health, and maternal care utilization and provision. One of each township pair was randomly allocated to the intervention or control groups. The trial interventions were: 1) training township hospital midwives and instructing them in how to provide systematic maternal care, 2) informing women in the community of the importance of prenatal care, 3) if needed, providing basic medical instruments to the hospitals. A variety of data sources were used to describe the trial implementation (observations, group discussions, field notes, survey to women). The data on pregnancy and perinatal outcomes were from the original hand-written work-records in the village family planning centers of the study townships. Implementation of the intervention was deficient. The factors hindering the trial implementation included poor coordination between midwives and family planning officers, broader policy changes implemented by the provincial government during the trial, the decentralization of county governance, and the lack of government funding for maternal care. There was only little difference in the use of maternal care, in women's opinions related to maternal care or content of prenatal care, and no difference in the perinatal outcomes between the intervention and control townships. A community based randomized controlled trial could not be fully carried out in rural China as planned due to the changing political landscape, the complexity of the socio-economic situation and a lengthy planning stage. The study

  9. Application of dietary fiber in clinical enteral nutrition: A meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    Gang Yang; Xiao-Ting Wu; Yong Zhou; Ying-Li Wang

    2005-01-01

    AIM: To evaluate the effects of dietary fiber (DF) as a part of enteral nutrition (EN) formula on diarrhea, infection, and length of hospital stay.METHODS: Following electronic databases were searched for randomized controlled trials about DF: Chinese Biomedicine Database (CBM), MEDLINE, EMBASE and Cochrane Controlled Trials Register. RevMan 4.1 was used for statistical analysis.RESULTS: Seven randomized controlled trials with 400pat-ients were included. The supplement of DF in EN was compared with standard enteral formula in five trials.Combined analysis did not show a significant reduction in occurrence of diarrhea, but there were valuable results for non-critically iii patients. Combined analysis of two trials observing the infection also did not show any valid evidence that DF could decrease the infection rate, though the length of hospital stay was reduced significantly.CONCLUSION: Based on the current eligible randomized controlled trials, there is no evidence that the value of DF in the diarrhea can be proved. Though length of hospital stay was shortened by the use of DF, there is no available evidence in preventing infection by DF. Further studies are needed for evaluating the value of DF in EN.

  10. A meta-analysis of randomized controlled trials of telmisartan for flow-mediated dilatation.

    Science.gov (United States)

    Takagi, Hisato; Umemoto, Takuya

    2014-09-01

    There have been a number of small-sized underpowered randomized controlled trials to assess effects of telmisartan on flow-mediated dilatation (FMD). To determine whether telmisartan increases FMD, we performed a meta-analysis of these trials. MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched through December 2013. Eligible studies were prospective randomized controlled trials of telmisartan reporting FMD as an outcome. Search terms included: telmisartan; endothelial function/dysfunction; flow-mediated dilation/dilatation/vasodilation/vasodilatation; and randomized, randomly or randomization. Included studies were reviewed to determine the number of patients randomized, mean duration of treatment and percent changes of FMD. Of 25 potentially relevant articles screened initially, seven reports of randomized trials enrolling a total of 398 patients were identified and included. A pooled analysis of the seven trials demonstrated a statistically significant increase in FMD by 48.7%, with telmisartan relative to control in the random-effects model (mean difference, 48.72%; 95% confidence interval, 15.37-82.08%; P for effect=0.004; P for heterogeneity telmisartan, which suggests that telmisartan may improve endothelial dysfunction.

  11. An integrated approach to consumer representation and involvement in a multicentre randomized controlled trial.

    Science.gov (United States)

    Langston, Anne L; McCallum, Marilyn; Campbell, Marion K; Robertson, Clare; Ralston, Stuart H

    2005-01-01

    Although, consumer involvement in individual studies is often limited, their involvement in guiding health research is generally considered to be beneficial. This paper outlines our experiences of an integrated relationship between the organisers of a clinical trial and a consumer organisation. The PRISM trial is a UK multicentre, randomized controlled trial comparing treatment strategies for Paget's disease of the bone. The National Association for the Relief of Paget's Disease (NARPD) is the only UK support group for sufferers of Paget's disease and has worked closely with the PRISM team from the outset. NARPD involvement is integral to the conduct of the trial and specific roles have included: peer-review; trial steering committee membership; provision of advice to participants, and promotion of the trial amongst Paget's disease patients. The integrated relationship has yielded benefits to both the trial and the consumer organisation. The benefits for the trial have included: recruitment of participants via NARPD contacts; well-informed participants; unsolicited patient advocacy of the trial; and interested and pro-active collaborators. For the NARPD and Paget's disease sufferers, benefits have included: increased awareness of Paget's disease; increased access to relevant health research; increased awareness of the NARPD services; and wider transfer of diagnosis and management knowledge to/from health care professionals. Our experience has shown that an integrated approach between a trial team and a consumer organisation is worthwhile. Adoption of such an approach in other trials may yield significant improvements in recruitment and quality of participant information flow. There are, however, resource implications for both parties.

  12. Treatment success in cancer: industry compared to publicly sponsored randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Benjamin Djulbegovic

    Full Text Available OBJECTIVE: To assess if commercially sponsored trials are associated with higher success rates than publicly-sponsored trials. STUDY DESIGN AND SETTINGS: We undertook a systematic review of all consecutive, published and unpublished phase III cancer randomized controlled trials (RCTs conducted by GlaxoSmithKline (GSK and the NCIC Clinical Trials Group (CTG. We included all phase III cancer RCTs assessing treatment superiority from 1980 to 2010. Three metrics were assessed to determine treatment successes: (1 the proportion of statistically significant trials favouring the experimental treatment, (2 the proportion of the trials in which new treatments were considered superior according to the investigators, and (3 quantitative synthesis of data for primary outcomes as defined in each trial. RESULTS: GSK conducted 40 cancer RCTs accruing 19,889 patients and CTG conducted 77 trials enrolling 33,260 patients. 42% (99%CI 24 to 60 of the results were statistically significant favouring experimental treatments in GSK compared to 25% (99%CI 13 to 37 in the CTG cohort (RR = 1.68; p = 0.04. Investigators concluded that new treatments were superior to standard treatments in 80% of GSK compared to 44% of CTG trials (RR = 1.81; p<0.001. Meta-analysis of the primary outcome indicated larger effects in GSK trials (odds ratio = 0.61 [99%CI 0.47-0.78] compared to 0.86 [0.74-1.00]; p = 0.003. However, testing for the effect of treatment over time indicated that treatment success has become comparable in the last decade. CONCLUSIONS: While overall industry sponsorship is associated with higher success rates than publicly-sponsored trials, the difference seems to have disappeared over time.

  13. Impact of icodextrin on clinical outcomes in peritoneal dialysis: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Cho, Yeoungjee; Johnson, David W; Badve, Sunil; Craig, Jonathan C; Strippoli, Giovanni F K; Wiggins, Kathryn J

    2013-07-01

    Although icodextrin has been shown to augment peritoneal ultrafiltration in peritoneal dialysis (PD) patients, its impact upon other clinical end points, such as technique survival, remains uncertain. This systematic review evaluated the effect of icodextrin use on patient level clinical outcomes. The Cochrane CENTRAL Registry, MEDLINE, Embase and reference lists were searched (last search 13 September 2012) for randomized controlled trials of icodextrin versus glucose in the long dwell exchange. Summary estimates of effect were obtained using a random effects model. Eleven eligible trials (1222 patients) were identified. There was a significant reduction in episodes of uncontrolled fluid overload [two trials; 100 patients; relative risk (RR) 0.30, 95% confidence interval (CI) 0.15-0.59] and improvement in peritoneal ultrafiltration [four trials; 102 patients; mean difference (MD) 448.54 mL/day, 95% CI 289.28-607.80] without compromising residual renal function [four trials; 114 patients; standardized MD (SMD) 0.12, 95% CI -0.26 to 0.49] or urine output (three trials; 69 patients; MD -88.88, 95% CI -356.88 to 179.12) with icodextrin use for up to 2 years. There was no significant effect on peritonitis incidence (five trials; 607 patients; RR 0.97, 95% CI 0.76-1.23), peritoneal creatinine clearance (three trials; 237 patients; SMD 0.36, 95% CI -0.24 to 0.96), technique failure (three trials; 290 patients; RR 0.58, 95% CI 0.28-1.20), patient survival (six trials; 816 patients; RR 0.82, 95% CI 0.32-2.13) or adverse events. Icodextrin prescription improved peritoneal ultrafiltration, mitigated uncontrolled fluid overload and was not associated with increased risk of adverse events. No effects of icodextrin on technique or patient survival were observed, although trial sample sizes and follow-up durations were limited.

  14. The informed consent process in randomised controlled trials: a nurse-led process.

    Science.gov (United States)

    Cresswell, Pip; Gilmour, Jean

    2014-03-01

    Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

  15. Mapping randomized controlled trials of treatments for eczema - The GREAT database (The Global Resource of Eczema Trials: a collection of key data on randomized controlled trials of treatments for eczema from 2000 to 2010

    Directory of Open Access Journals (Sweden)

    Williams Hywel C

    2011-05-01

    Full Text Available Abstract Background Massive duplication of effort occurs when researchers all over the world undertake extensive searches for randomized controlled trials when preparing systematic reviews, when developing evidence-based guidelines and when applying for research funding for eczema treatments. Such duplication wastes valuable resources. Searching for randomized controlled trials of eczema is a laborious task involving scrutiny of thousands of individual references from diverse electronic databases in order to obtain a few papers of interest. Clinicians and patients who wish to find out more about a particular treatment are at risk of missing the relevant evidence if they are not trained in electronic bibliographic searching. Systematic reviews cannot be relied upon to comprehensively inform current optimal eczema treatments due to incomplete coverage and because many may be out of date. An international, publically available and comprehensive resource which brings together all randomized controlled trials on eczema treatment using a highly sensitive search has the potential to release more filtered knowledge about patient care to those who need it most and to significantly shorten the duration and costs of many clinical eczema research and guideline projects. Description The Global Resource of EczemA Trials brings together information on all randomized controlled trials of eczema treatments published from the beginning of 2000 up to the end of 2010 and will be updated every month. We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library and the Cochrane Skin Group Specialised Register, MEDLINE, EMBASE, LILACS, AMED and CINHAL databases. We included 268 RCTs (24th March 2011 covering over 70 different treatment interventions. The structure of the Global Resource of Eczema Trials allows the user as much, or as little, specificity when retrieving information on trials as they wish, in an easy to use format. For each

  16. The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Campbell Karen

    2008-03-01

    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  17. Ethics of Placebo Control in Trials for Idiopathic Sudden Sensorineural Hearing Loss.

    Science.gov (United States)

    Maldonado Fernández, Miguel; Kornetsky, Susan; Rubio Rodriguez, Laura

    2016-07-01

    Idiopathic sudden sensorineural hearing loss (ISSHL) involves sudden loss of hearing from cochlear or retrocochlear origin of unknown cause. Systemic corticosteroids may be considered in the management of ISSNHL. However, an updated Cochrane systematic review concludes that "the value of steroids in the treatment of idiopathic sudden sensorineural hearing loss remains unclear since the evidence obtained from randomized controlled trials is contradictory in outcome." Therefore, a new clinical trial that addresses this question is mandatory. A first step in its design is to determine if placebo control would be ethically acceptable. We conclude that there is equipoise (uncertainty) about the use of corticosteroids for ISSHL. A new trial is justified-but with the inclusion of interim analyses to detect early imbalances on efficacy or safety and with the ability to stop the trial if needed. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

  18. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

    DEFF Research Database (Denmark)

    Bello, Segun; Wei, Maoling; Hilden, Jørgen

    2016-01-01

    to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching. Methods: Systematic review. We searched Pub......Background: Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided......Med, Google Scholar and Web of Science Citation Index for studies that assessed whether supposedly indistinguishable interventions (experimental and control) in randomized clinical drug trials could be distinguished based on physical properties (e.g. appearance or smell). Two persons decided on study...

  19. Inefficient cognitive control in adult ADHD: evidence from trial-by-trial Stroop test and cued task switching performance

    Directory of Open Access Journals (Sweden)

    Heuser Isabella

    2007-08-01

    Full Text Available Abstract Background Contemporary neuropsychological models of ADHD implicate impaired cognitive control as contributing to disorder characteristic behavioral deficiencies and excesses; albeit to varying degrees. While the traditional view of ADHD postulates a core deficiency in cognitive control processes, alternative dual-process models emphasize the dynamic interplay of bottom-up driven factors such as activation, arousal, alerting, motivation, reward and temporal processing with top-down cognitive control. However, neuropsychological models of ADHD are child-based and have yet to undergo extensive empirical scrutiny with respect to their application to individuals with persistent symptoms in adulthood. Furthermore, few studies of adult ADHD samples have investigated two central cognitive control processes: interference control and task-set coordination. The current study employed experimental chronometric Stroop and task switching paradigms to investigate the efficiency of processes involved in interference control and task-set coordination in ADHD adults. Methods 22 adults diagnosed with persistent ADHD (17 males and 22 matched healthy control subjects performed a manual trial-by-trial Stroop color-word test and a blocked explicitly cued task switching paradigm. Performance differences between neutral and incongruent trials of the Stroop task measured interference control. Task switching paradigm manipulations allowed for measurement of transient task-set updating, sustained task-set maintenance, preparatory mechanisms and interference control. Control analyses tested for the specificity of group × condition interactions. Results Abnormal processing of task-irrelevant stimulus features was evident in ADHD group performance on both tasks. ADHD group interference effects on the task switching paradigm were found to be dependent on the time allotted to prepare for an upcoming task. Group differences in sustained task-set maintenance and

  20. Developing a survey of barriers and facilitators to recruitment in randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Kaur Geetinder

    2012-11-01

    Full Text Available Abstract Background Recruitment to randomized controlled trials is known to be challenging. It is important to understand and identify predictors of good or poor accrual to a clinical trial so that appropriate strategies can be put in place to overcome these problems and facilitate successful trial completion. We have developed a survey tool to establish the recruitment experience of clinical teams regarding facilitators and barriers to recruitment in a clinical trial and describe herein the method of developing the questionnaire. Methods A literature search was conducted to identify studies that have explored facilitators and barriers to recruitment, and a list of potential factors affecting recruitment to a clinical trial was generated. These factors were categorized in terms relating to the (i trial, (ii site, (iii patient, (iv clinical team, (v information and consent and (vi study team. A list was provided for responders to grade these factors as weak, intermediate or strong facilitators or barriers to recruitment. Results A web-based survey questionnaire was developed. This survey was designed to establish the recruitment experience of clinical teams with regard to the perceived facilitators and barriers to recruitment, to identify strategies applied to overcome these problems, and to obtain suggestions for change in the organization of future trials. The survey tool can be used to assess the recruitment experience of clinical teams in a single/multicenter trial in any clinical setting or speciality involving adults or children either in an ongoing trial or at trial completion. The questionnaire is short, easy to administer and to complete, with an estimated completion time of 11 minutes. Conclusions We have presented a robust methodology for developing this survey tool that provides an evidence-based list of potential factors that can affect recruitment to a clinical trial. We recommend that all clinical trialists should consider using

  1. Effect of Probiotics on Glycemic Control: A Systematic Review and Meta-Analysis of Randomized, Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Yuting Ruan

    Full Text Available Previous clinical trials indicate that probiotic consumption may improve blood glucose control, however, results from randomized trials on glycemic control have been inconsistent.To investigate the effects of probiotics on glycemic control in a systematic review and meta-analysis of randomized controlled trials.PubMed, Embase, Cochrane Library, and Clinicaltrial.gov through October 2014.Two independent reviewers extracted relevant data and assessed study quality and risk of bias. Data were pooled using a random-effects model and expressed as mean differences (MD with 95% CI. Heterogeneity was assessed (Cochran Q-statistic and quantified (I2.Seventeen randomized controlled trials were included, in which 17 fasting blood glucose (n = 1105, 11 fasting plasma insulin (n = 788, 8 homeostasis model assessment of insulin resistance (n = 635 comparisons were reported. Probiotic consumption, compared with placebo, significantly reduced fasting glucose (MD = -0.31 mmol/L; 95% CI 0.56, 0.06; p = 0.02, fasting plasma insulin (MD = -1.29 μU/mL; 95% CI -2.17, -0.41; p = 0.004, and HOMA-IR (MD = 0.48; 95% CI -0.83, -0.13; p = 0.007.Probiotic consumption may improve glycemic control modestly. Modification of gut microbiota by probiotic supplementation may be a method for preventing and control hyperglycemia in clinical practice.

  2. Does mindfulness works in real life outside controlled clinical trials?

    DEFF Research Database (Denmark)

    Juul, Lise; Pallesen, Karen Johanne; Piet, Jacob

    2017-01-01

    We aimed to evaluate the effectiveness of Mindfulness Based Stress Reduction (MBSR) when implemented as a self-referred and self-paid course in a community setting. Pre–post changes and Cohen´s d were calculated for questionnaire measures of mindfulness, perceived stress and symptoms of anxiety......-paid course in the community delivered by several MBSR teachers. The effects were greatest among the participants with most self-perceived stress at baseline, and the results were comparable to results derived from reference trials. The participants were mainly highly educated, middle-aged women with more......±10.4 years; 75 % of the participants had more than 15 years of education; 38 % had a Perceived Stress Scale (PSS)-score ≥18; and 27 % had a history of mental disorder. The proportion with PSS≥18 decreased with -16%-points (95%CI: -26 to -6). Within group effect sizes for our total study population; subgroup...

  3. Refractive predictability in eyes with intraocular gas tamponade - results of a prospective controlled clinical trial.

    Science.gov (United States)

    Wagenfeld, Lars; Hermsdorf, Kristin; Stemplewitz, Birthe; Druchkiv, Vasyl; Frings, Andreas

    2017-01-01

    To determine the postoperative refractive error in eyes with intraocular gas tamponade in combined phacovitrectomy using a Z-haptic intraocular lens (IOL). This prospective non-randomized case-control study compared patients with combined phacovitrectomy with or without intraocular gas tamponade to cataract surgery-only. The main outcome measure was the IOL power prediction error (PE). Secondary outcome measures were spherical equivalent, anterior chamber depth (ACD), and axial length. Thirty-four patients with epiretinal membranes and 18 patients with cataract only were enrolled. There were no statistically significant (P>0.05) differences of IOL power PE or postoperative ACDs (P=0.952-1.00). Nevertheless, IOL power PE indicated a myopic shift in cases with phacovitrectomy independent of gas tamponade (P=1.00). No statistically significant between-group differences between secondary outcome measures were observed. A myopic shift after phacovitrectomy seems to be independent of the use of intraocular gas tamponade. When using a Z-haptic IOL, aiming for slight residual hyperopia (+0.50 D) is suggested in patients having phacovitrectomy.

  4. Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yan Jie

    2009-08-01

    Full Text Available Abstract Background Acupuncture is widely used in China to treat functional dyspepsia (FD. However, its effectiveness in the treatment of FD, and whether FD-specific acupoints exist, are controversial. So this study aims to determine if acupuncture is an effective treatment for FD and if acupoint specificity exists according to traditional acupuncture meridians and acupoint theories. Design This multicenter randomized controlled trial will include four acupoint treatment groups, one non-acupoint control group and one drug (positive control group. The four acupoint treatment groups will focus on: (1 specific acupoints of the stomach meridian; (2 non-specific acupoints of the stomach meridian; (3 specific acupoints of alarm and transport points; and (4 acupoints of the gallbladder meridian. These four groups of acupoints are thought to differ in terms of clinical efficacy, according to traditional acupuncture meridians and acupoint theories. A total of 120 FD patients will be included in each group. Each patient will receive 20 sessions of acupuncture treatment over 4 weeks. The trial will be conducted in eight hospitals located in three centers of China. The primary outcomes in this trial will include differences in Nepean Dyspepsia Index scores and differences in the Symptom Index of Dyspepsia before randomization, 2 weeks and 4 weeks after randomization, and 1 month and 3 months after completing treatment. Discussion The important features of this trial include the randomization procedures (controlled by a central randomization system, a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy. Trial registration number Clinical Trials

  5. Acupoints Stimulation for Anxiety and Depression in Cancer Patients: A Quantitative Synthesis of Randomized Controlled Trials

    OpenAIRE

    2016-01-01

    This study aims at concluding the current evidence on the therapeutic effects of acupoints stimulation for cancer patients with anxiety and depression. Randomized controlled trials using acupoints stimulation for relieving anxiety and/or depression in cancer patients were searched, and 11 studies were finally included, of which eight trials compared acupoints stimulation with standard methods of treatment/care, and acupoints stimulation showed significantly better effects in improving depress...

  6. Changes Within Clinical Practice After a Randomized Controlled Trial of Knee Arthroscopy for Osteoarthritis

    OpenAIRE

    Amin, Nirav H; Hussain, Waqas; Ryan, John; Morrison, Shannon; Miniaci, Anthony; Jones, Morgan H.

    2017-01-01

    Background: In 2002, Moseley et al published a randomized controlled trial (RCT) that showed no difference between knee arthroscopy and placebo for patients with osteoarthritis (OA). We wanted to assess the impact of the trial on clinical practice in the United States. Purpose/Hypothesis: To evaluate changes in knee arthroscopy practice before and after publication of the article by Moseley et al and to assess the effect of this landmark RCT on the behavior of practicing orthopaedic surgeons....

  7. Early mortality of alcoholic hepatitis: A review of data from placebo-controlled clinical trials

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    AIM: To investigate the early mortality of placebo-treated alcoholic hepatitis patients. METHODS: Mortality data about alcoholic hepatitis patients who participated in randomized placebo-controlled trials were searched from PubMed, EMBASE, and Cochrane Library, extracted and analyzed. RESULTS: A total of 661 placebo-treated patients in 19 trials were included. The overall mortality rate was 34.19% with a median observation time of 160 d (range 21-720 d). Hepatic failure, gastrointestinal bleeding and infect...

  8. Increasing participation of cancer patients in randomised controlled trials: a systematic review

    Directory of Open Access Journals (Sweden)

    Stirk Lisa

    2006-05-01

    Full Text Available Abstract Background There are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs of cancer treatments. Methods A systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted. Results Eight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work. Conclusion There is not a strong evidence-base for interventions that

  9. Surgery versus prolonged conservative treatment for sciatica: 5-year results of a randomised controlled trial

    OpenAIRE

    Lequin, Michiel B.; Verbaan, Dagmar; Jacobs, Wilco C. H.; Brand, Ronald; Gerrit J. Bouma; Vandertop, William P.; Peul, Wilco C; ,

    2013-01-01

    Objective This study describes the 5 years’ results of the Sciatica trial focused on pain, disability, (un)satisfactory recovery and predictors for unsatisfactory recovery. Design A randomised controlled trial. Setting Nine Dutch hospitals. Participants Five years’ follow-up data from 231 of 283 patients (82%) were collected. Intervention Early surgery or an intended 6 months of conservative treatment. Main outcome measures Scores from Roland disability questionnaire, visual analogue scale (V...

  10. Literature review of vaccine-related adverse events reported from HPV vaccination in randomized controlled trials

    OpenAIRE

    Macki, Mohamed; Dabaja, Ali A.

    2016-01-01

    Background The human papilloma virus (HPV) infections were addressed with two FDA-approved HPV vaccines: quadrivalent and bivalent vaccine. The objective of this manuscript is to determine the safety of the HPV vaccine. Results A search of PubMed articles for “human papillomavirus vaccine” was used to identify all-type HPV clinical studies prior to October 2014. A refined search of clinical trials, multicenter studies, and randomized studies were screened for only randomized controlled trials...

  11. Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia.

    Science.gov (United States)

    Holman, Andrew J

    2008-12-01

    A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

  12. The outcomes of a 12-week Internet intervention aimed at improving fitness and health-related quality of life in overweight adolescents: the Young & Active controlled trial.

    Directory of Open Access Journals (Sweden)

    Kirsti Riiser

    Full Text Available Overweight and obesity among adolescents may have consequences, with potentially lasting effects on health and health-related quality of life (HRQoL. Excess weight is also associated with decreases in physical activity and cardiorespiratory fitness. The aim of the current study was to investigate the short-term effects of a 12-week Internet intervention in a primary care setting intended to increase cardiorespiratory fitness and HRQoL among overweight and obese adolescents.In this controlled trial, participants (13-15 years were non-randomly allocated to an intervention- or a control group. The intervention group received 12-weeks access to an online program providing tailored physical activity counseling based on principles from Self-determination Theory and Motivational Interviewing. The control group received standard follow-up by the school nurses. The primary outcome measure of cardiorespiratory fitness was determined using a shuttle run test. The secondary outcomes: HRQoL, leisure time exercise, body image and self-determined motivation for physical activity and exercise, were assessed by self-report measures. Age- and gender-adjusted body mass index (BMI was calculated based on measurements of height and weight. To compare pre-to post intervention differences within groups, a paired samples t-test was used while crude differences between groups were analyzed with an independent samples t-test.Of the 120 participants, 108 completed the study, 75 in the intervention group and 33 in the control group. Exposure to the intervention had a small effect on cardiorespiratory fitness (0.14; 95% CI [0.01;0.28]; P = 0.04, and a moderate effect on HRQoL (5.22; 95% CI [0.90; 9.53]; P = 0.02. Moreover, the control group increased significantly in BMI, yielding a moderate preventive effect on BMI (-0.39; 95% CI [-0.74;-0.03]; P = 0.03 for the intervention group.The results suggest that the Internet intervention with tailored physical activity counseling

  13. Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS Trial: study protocol for a randomized controlled trial

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    Dörr Jan

    2012-02-01

    Full Text Available Abstract Background Multiple sclerosis is the most common chronic inflammatory disease of the central nervous system in young adults. Despite the fact that numerous lines of evidence link both the risk of disease development and the disease course to the serum level of 25-hydroxyvitamin D it still remains elusive whether multiple sclerosis patients benefit from boosting the serum level of 25-hydroxyvitamin D, mainly because interventional clinical trials that directly address the therapeutic effects of vitamin D in multiple sclerosis are sparse. We here present the protocol of an interventional clinical phase II study to test the hypothesis, that high-dose vitamin D supplementation of multiple sclerosis patients is safe and superior to low-dose supplementation with respect to beneficial therapeutic effects. Methods/Design The EVIDIMS trial is a German multi-center, stratified, randomized, controlled and double-blind clinical phase II pilot study. Eighty patients with the diagnosis of definite multiple sclerosis or clinically isolated syndrome who are on a stable immunomodulatory treatment with interferon-β1b will be randomized to additionally receive either high-dose (average daily dose 10.200 IU or low-dose (average daily dose 200 IU cholecalciferol for a total period of 18 months. The primary outcome measure is the number of new lesions detected on T2-weighted cranial MRI at 3 tesla. Secondary endpoints include additional magnetic resonance imaging and optical coherence tomography parameters for neuroinflammation and -degeneration, clinical parameters for disease activity, as well as cognition, fatigue, depression, and quality of life. Safety and tolerability of high-dose vitamin D supplementation are further outcome parameters. Discussion In light of the discrepancy between existing epidemiological and preclinical data on the one hand and available clinical data on the other the EVIDIMS trial will substantially contribute to the evaluation

  14. The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly

    Directory of Open Access Journals (Sweden)

    Ruikes Franca GH

    2012-12-01

    Full Text Available Abstract Background With increasing age and longevity, the rising number of frail elders with complex and numerous health-related needs demands a coordinated health care delivery system integrating cure, care and welfare. Studies on the effectiveness of such comprehensive chronic care models targeting frail elders show inconclusive results. The CareWell-primary care program is a complex intervention targeting community-dwelling frail elderly people, that aims to prevent functional decline, improve quality of life, and reduce or postpone hospital and nursing home admissions of community dwelling frail elderly. Methods/design The CareWell-primary care study includes a (cost- effectiveness study and a comprehensive process evaluation. In a one-year pragmatic, cluster controlled trial, six general practices are non-randomly recruited to adopt the CareWell-primary care program and six control practices will deliver ‘care as usual’. Each practice includes a random sample of fifty frail elders aged 70 years or above in the cost-effectiveness study. A sample of patients and informal caregivers and all health care professionals participating in the CareWell-primary care program are included in the process evaluation. In the cost-effectiveness study, the primary outcome is the level of functional abilities as measured with the Katz-15 index. Hierarchical mixed-effects regression models / multilevel modeling approach will be used, since the study participants are nested within the general practices. Furthermore, incremental cost-effectiveness ratios will be calculated as costs per QALY gained and as costs weighed against functional abilities. In the process evaluation, mixed methods will be used to provide insight in the implementation degree of the program, patients’ and professionals’ approval of the program, and the barriers and facilitators to implementation. Discussion The CareWell-primary care study will provide new insights into the (cost

  15. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

    Directory of Open Access Journals (Sweden)

    Luke Perraton

    2009-11-01

    Full Text Available Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS. The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery were analyzed.Results: Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery.Conclusions: Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.Keywords: hydrotherapy, fibromyalgia syndrome, exercise, effective, components

  16. Primary outcomes in two randomized controlled trials of treatments for cannabis use disorders.

    Science.gov (United States)

    Peters, Erica N; Nich, Charla; Carroll, Kathleen M

    2011-11-01

    While several randomized controlled trials evaluating a range of treatments for cannabis use disorders have appeared in recent years, these have been marked by inconsistency in selection of primary outcomes, making it difficult to compare outcomes across studies. With the aim of identifying meaningful and reliable outcome domains in treatment studies of cannabis use disorders, we evaluated multiple indicators of marijuana use, marijuana problems, and psychosocial functioning from two independent randomized controlled trials of behavioral treatments for cannabis use disorders (Ns=450 and 136). Confirmatory factor analysis indicated that the best-fitting model of outcomes in both trials encompassed three distinct factors: frequency of marijuana use, severity of marijuana use, and psychosocial functioning. In both trials, frequency of marijuana use and longest period of abstinence during treatment were most strongly associated with outcome during follow-up. Using two categorical definitions of "clinically significant improvement," individuals who demonstrated improvement differed on most end-of-treatment and long-term outcomes from those who did not improve. Results may guide future randomized controlled trials of treatments for cannabis use disorders in the collection of relevant end-of-treatment outcomes and encourage consistency in the reporting of outcomes across trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  17. PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids.

    Science.gov (United States)

    Jacoby, Vanessa L; Kohi, Maureen P; Poder, Liina; Jacoby, Alison; Lager, Jeanette; Schembri, Michael; Rieke, Viola; Grady, Deborah; Vittinghoff, Eric; Coakley, Fergus V

    2016-03-01

    To evaluate the feasibility of a full-scale placebo-controlled trial of magnetic resonance-guided focused ultrasound for fibroids (MRgFUS) and obtain estimates of safety and efficacy. Pilot, randomized, placebo-controlled trial. University medical center. Premenopausal women with symptomatic uterine fibroids. Participants randomized in a 2:1 ratio to receive MRgFUS or placebo procedure. change in fibroid symptoms from baseline to 4 and 12 weeks after treatment assessed by the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL); secondary outcome: incidence of surgery or procedures for recurrent symptoms at 12 and 24 months. Twenty women with a mean age of 44 years (±standard deviation 5.4 years) were enrolled, and 13 were randomly assigned to MRgFUS and 7 to placebo. Four weeks after treatment, all participants reported improvement in the UFS-QOL: a mean of 10 points in the MRgFUS group and 9 points in the placebo group (for difference in change between groups). By 12 weeks, the MRgFUS group had improved more than the placebo group (mean 31 points and 13 points, respectively). The mean fibroid volume decreased 18% in the MRgFUS group with no decrease in the placebo group at 12 weeks. Two years after MRgFUS, 4 of 12 women who had a follow-up evaluation (30%) had undergone another fibroid surgery or procedure. Women with fibroids were willing to enroll in a randomized, placebo-controlled trial of MRgFUS. A placebo effect may explain some of the improvement in fibroid-related symptoms observed in the first 12 weeks after MRgFUS. NCT01377519. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  18. Efficacy and safety of aceclofenac in osteoarthritis: A meta-analysis of randomized controlled trials

    Science.gov (United States)

    Patel, Parvati B.; Patel, Tejas K.

    2017-01-01

    Objective To analyze the effects on pain, function, and safety of aceclofenac compared with other nonsteroidal anti-inflammatory drugs (NSAIDs) or pain relief medications in patients with osteoarthritis. Material and Methods Two investigators independently searched the database. We included randomized controlled trials evaluating efficacy and/or safety of aceclofenac compared with control interventions (NSAIDs or acetaminophen) in patients with osteoarthritis. We did not include placebo, opioid analgesics, NSAID combinations, and topical analgesics for the control groups. We summarized the efficacy data as standardized mean differences (SMD) with 95% confidence intervals (CI) and safety outcomes as risk ratios (RR) with 95% CI using the inverse variance random effect model. We assessed the heterogeneity by the I2 test. We used the GRADE approach to evaluate the quality of the evidence for all outcome parameters. Results We included 9 trials (8 double blind and 1 single blind) that evaluated pain (7 trials), function (8 trials) and safety (7 trials). We observed no significant difference in pain reduction between aceclofenac and control interventions [SMD: −0.30 (−0.62, 0.01); I2=88%; GRADE evidence- low]. Aceclofenac was more beneficial than control interventions in improving physical function [SMD: −0.27 (−0.50, −0.03); I2=88%; GRADE evidence- low]. We observed less gastrointestinal adverse events for aceclofenac than in control interventions [RR 0.69 (95% CI: 0.57, 0.83); I2=12%; GRADE evidence- moderate]. We observed no difference in overall adverse events occurrence and dropout rate between aceclofenac and control interventions. Conclusion We observed that aceclofenac was beneficial over control analgesics for function improvement and to minimize gastrointestinal adverse events. Our findings could be biased due to the heterogeneity of the sample, the fact that the trials were small and methodological issues. PMID:28293447

  19. Control Group Design, Contamination and Drop-Out in Exercise Oncology Trials : A Systematic Review

    NARCIS (Netherlands)

    Bisschop, Charlotte N. Steins; Courneya, Kerry S.; Velthuis, Miranda J.; Monninkhof, Evelyn M.; Jones, Lee W.; Friedenreich, Christine; van der Wall, Elsken; Peeters, Petra H. M.; May, Anne M.

    2015-01-01

    Purpose Important considerations for exercise trials in cancer patients are contamination and differential drop-out among the control group members that might jeopardize the internal validity. This systematic review provides an overview of different control groups design characteristics of exercise-

  20. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    Science.gov (United States)

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  1. A Compound Herbal Preparation (CHP) in the Treatment of Children with ADHD: A Randomized Controlled Trial

    Science.gov (United States)

    Katz, M.; Adar Levine, A.; Kol-Degani, H.; Kav-Venaki, L.

    2010-01-01

    Objective: Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. Method: Design: A randomized, double-blind, placebo-controlled trial. Setting: University-affiliated tertiary medical center. Participants: 120 children newly diagnosed with ADHD,…

  2. Efficacy of the "Responsive Classroom" Approach: Results from a 3-Year, Longitudinal Randomized Controlled Trial

    Science.gov (United States)

    Rimm-Kaufman, Sara E.; Larsen, Ross A. A.; Baroody, Alison E.; Curby, Timothy W.; Ko, Michelle; Thomas, Julia B.; Merritt, Eileen G.; Abry, Tashia; DeCoster, Jamie

    2014-01-01

    This randomized controlled field trial examined the efficacy of the Responsive Classroom (RC) approach on student achievement. Schools (n = 24) were randomized into intervention and control conditions; 2,904 children were studied from end of second to fifth grade. Students at schools assigned to the RC condition did not outperform students at…

  3. Intention-to-Treat Analysis in Partially Nested Randomized Controlled Trials with Real-World Complexity

    Science.gov (United States)

    Schweig, Jonathan David; Pane, John F.

    2016-01-01

    Demands for scientific knowledge of what works in educational policy and practice has driven interest in quantitative investigations of educational outcomes, and randomized controlled trials (RCTs) have proliferated under these conditions. In educational settings, even when individuals are randomized, both experimental and control students are…

  4. Effectiveness in practice-based research: Looking for alternatives to the randomized controlled trial (RCT)

    NARCIS (Netherlands)

    L. Tavecchio

    2015-01-01

    Over the last decade, the status of the randomized controlled trial (RCT), hallmark of evidence-based medicine (research), has been growing strongly in general practice, social work and public health. But this type of research is only practicable under strictly controlled and well-defined settings a

  5. Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

    Science.gov (United States)

    Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

    2013-01-01

    The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

  6. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    Science.gov (United States)

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  7. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    Science.gov (United States)

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  8. Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

    Science.gov (United States)

    Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

    2013-01-01

    The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

  9. Control group design, contamination and drop-out in exercise oncology trials: a systematic review.

    Science.gov (United States)

    Steins Bisschop, Charlotte N; Courneya, Kerry S; Velthuis, Miranda J; Monninkhof, Evelyn M; Jones, Lee W; Friedenreich, Christine; van der Wall, Elsken; Peeters, Petra H M; May, Anne M

    2015-01-01

    Important considerations for exercise trials in cancer patients are contamination and differential drop-out among the control group members that might jeopardize the internal validity. This systematic review provides an overview of different control groups design characteristics of exercise-oncology trials and explores the association with contamination and drop-out rates. Randomized controlled exercise-oncology trials from two Cochrane reviews were included. Additionally, a computer-aided search using Medline (Pubmed), Embase and CINAHL was conducted after completion date of the Cochrane reviews. Eligible studies were classified according to three control group design characteristics: the exercise instruction given to controls before start of the study (exercise allowed or not); and the intervention the control group was offered during (any (e.g., education sessions or telephone contacts) or none) or after (any (e.g., cross-over or exercise instruction) or none) the intervention period. Contamination (yes or no) and excess drop-out rates (i.e., drop-out rate of the control group minus the drop-out rate exercise group) were described according to the three design characteristics of the control group and according to the combinations of these three characteristics; so we additionally made subgroups based on combinations of type and timing of instructions received. 40 exercise-oncology trials were included based on pre-specified eligibility criteria. The lowest contamination (7.1% of studies) and low drop-out rates (excess drop-out rate -4.7±9.2) were found in control groups offered an intervention after the intervention period. When control groups were offered an intervention both during and after the intervention period, contamination (0%) and excess drop-out rates (-10.0±12.8%) were even lower. Control groups receiving an intervention during and after the study intervention period have lower contamination and drop-out rates. The present findings can be

  10. Effect of non-random dispersal strategies on spatial coexistence mechanisms.

    Science.gov (United States)

    Amarasekare, Priyanga

    2010-01-01

    1. Random dispersal leads to spatial coexistence via two mechanisms (emigration-mediated and source-sink), both of which involve the movement of organisms from areas of higher to lower fitness. What is not known is whether such coexistence would occur if organisms dispersed non-randomly, using cues such as density and habitat quality to gauge fitness differences between habitats. Here, I conduct a comparative analysis of random and non-random dispersal strategies in a foodweb with a basal resource, top predator, and two intermediate consumers that exhibit a trade-off between competitive ability and predator susceptibility. 2. I find a striking contrast between density- and habitat-dependent dispersal in their effects on spatial coexistence. Dispersal in response to competitor and predator density facilitates coexistence while dispersal in response to habitat quality (resource productivity and predator pressure) inhibits it. Moreover, density-dependent dispersal changes species' distribution patterns from interspecific segregation to interspecific aggregation, while habitat-dependent dispersal preserves the interspecific segregation observed in the absence of dispersal. Under density-dependent dispersal, widespread spatial coexistence results in an overall decline in the abundance of the inferior competitor that is less susceptible to predation and an overall increase in the abundance of the superior competitor that is more susceptible to predation. Under habitat-dependent dispersal, restricted spatial coexistence results in species' abundances being essentially unchanged from those observed in the absence of dispersal. 3. A key outcome is that when the superior competitor moves in the direction of increasing fitness but the inferior competitor does not, spatial coexistence is possible in both resource-poor and resource-rich habitats. However, when the inferior competitor moves in the direction of increasing fitness but the superior competitor does not, spatial

  11. Randomized controlled trials in central vascular access devices: A scoping review

    Science.gov (United States)

    Keogh, Samantha; Rickard, Claire M.

    2017-01-01

    Background Randomized controlled trials evaluate the effectiveness of interventions for central venous access devices, however, high complication rates remain. Scoping reviews map the available evidence and demonstrate evidence deficiencies to focus ongoing research priorities. Method A scoping review (January 2006–December 2015) of randomized controlled trials evaluating the effectiveness of interventions to improve central venous access device outcomes; including peripherally inserted central catheters, non-tunneled, tunneled and totally implanted venous access catheters. MeSH terms were used to undertake a systematic search with data extracted by two independent researchers, using a standardized data extraction form. Results In total, 178 trials were included (78 non-tunneled [44%]; 40 peripherally inserted central catheters [22%]; 20 totally implanted [11%]; 12 tunneled [6%]; 6 non-specified [3%]; and 22 combined device trials [12%]). There were 119 trials (68%) involving adult participants only, with 18 (9%) pediatric and 20 (11%) neonatal trials. Insertion-related themes existed in 38% of trials (67 RCTs), 35 RCTs (20%) related to post-insertion patency, with fewer trials on infection prevention (15 RCTs, 8%), education (14RCTs, 8%), and dressing and securement (12 RCTs, 7%). There were 46 different study outcomes reported, with the most common being infection outcomes (161 outcomes; 37%), with divergent definitions used for catheter-related bloodstream and other infections. Conclusion More high quality randomized trials across central venous access device management are necessary, especially in dressing and securement and patency. These can be encouraged by having more studies with multidisciplinary team involvement and consumer engagement. Additionally, there were extensive gaps within population sub-groups, particularly in tunneled devices, and in pediatrics and neonates. Finally, outcome definitions need to be unified for results to be meaningful and

  12. How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Schneider Antonius

    2010-11-01

    Full Text Available Abstract Background While several recent large randomized trials found clinically relevant effects of acupuncture over no treatment or routine care, blinded trials comparing acupuncture to sham interventions often reported only minor or no differences. This raises the question whether (sham acupuncture is associated with particularly potent nonspecific effects. We aimed to investigate the size of nonspecific effects associated with acupuncture interventions. Methods MEDLINE, Embase, Cochrane Central Register of Controlled Clinical Trials and reference lists were searched up to April 2010 to identify randomized trials of acupuncture for any condition, including both sham and no acupuncture control groups. Data were extracted by one reviewer and verified by a second. Pooled standardized mean differences were calculated using a random effects model with the inverse variance method. Results Thirty-seven trials with a total of 5754 patients met the inclusion criteria. The included studies varied strongly regarding patients, interventions, outcome measures, methodological quality and effect sizes reported. Among the 32 trials reporting a continuous outcome measure, the random effects standardized mean difference between sham acupuncture and no acupuncture groups was -0.45 (95% confidence interval, -0.57, -0.34; I2 = 54%; Egger's test for funnel plot asymmetry, P = 0.25. Trials with larger effects of sham over no acupuncture reported smaller effects of acupuncture over sham intervention than trials with smaller nonspecific effects (β = -0.39, P = 0.029. Conclusions Sham acupuncture interventions are often associated with moderately large nonspecific effects which could make it difficult to detect small additional specific effects. Compared to inert placebo interventions, effects associated with sham acupuncture might be larger, which would have considerable implications for the design and interpretation of clinical trials.

  13. 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.

  14. Transcutaneous electrical nerve stimulation for the management of tennis elbow: a pragmatic randomized controlled trial: the TATE trial (ISRCTN 87141084

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    Warlow Catherine

    2009-12-01

    Full Text Available Abstract Background Tennis elbow is a common and often extremely painful musculoskeletal condition, which has considerable impact on individuals as well as economic implications for healthcare utilization and absence from work. Many management strategies have been studied in clinical trials. Whilst corticosteroid injections offer short term pain relief, this treatment is unpleasant and is used with caution due to an associated high risk of pain recurrence in the long term. Systematic reviews conclude that there is no clear and effective treatment for symptoms of pain in the first 6 weeks of the condition. There is a clear need for an intervention that is acceptable to patients and provides them with effective short-term pain relief without increasing the risk of recurrence. Transcutaneous electrical nerve stimulation (TENS is an inexpensive, non-invasive, non-pharmacological form of analgesia that is commonly used in the treatment of pain. TENS has very few contraindications and is simple to apply. It also benefits from being patient controlled, thereby promoting self-management. This study aims to assess the effectiveness, in terms of pain relief, and cost-effectiveness of a self-management package of treatment that includes TENS. Methods/Design The design of the study will be a two-group pragmatic randomized clinical trial. 240 participants aged 18 years and over with tennis elbow will be recruited from 20-30 GP practices in Staffordshire, UK. Participants are to be randomized on a 1:1 basis to receive either primary care management (standard GP consultation, medication, advice and education or primary care management with the addition of TENS, over 6 weeks. Our primary outcome measure is average intensity of elbow pain in the past 24 hours (0-10 point numerical rating scale at 6 weeks. Secondary outcomes include pain and limitation of function, global assessment of change, days of sick leave, illness perceptions, and overall health status. A

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

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    Helliwell Philip S

    2007-11-01

    Full Text Available Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Methods Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF and activity limitation/participation restriction (LFISAP subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS, Health Assessment Questionnaire (HAQ score and walking speed (m/s were also recorded. Results Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores, there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF but not activity/participation (LFISAP or function (walking speed over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits and 3 self-withdrew (lost to follow-up. Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3, foot orthoses (n = 9, footwear referral to the orthotist (n = 5, and ultrasound

  16. Trial Protocol: Communicating DNA-based risk assessments for Crohn's disease: a randomised controlled trial assessing impact upon stopping smoking

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    Armstrong David

    2011-01-01

    Full Text Available Abstract Background Estimates of the risk of developing Crohn's disease (CD can be made using DNA testing for mutations in the NOD2 (CARD15 gene, family history, and smoking status. Smoking doubles the risk of CD, a risk that is reduced by stopping. CD therefore serves as a timely and novel paradigm within which to assess the utility of predictive genetic testing to motivate behaviour change to reduce the risk of disease. The aim of the study is to describe the impact upon stopping smoking of communicating a risk of developing CD that incorporates DNA analysis. We will test the following main hypothesis: Smokers who are first degree relatives (FDRs of CD probands are more likely to make smoking cessation attempts following communication of risk estimates of developing CD that incorporate DNA analysis, compared with an equivalent communication that does not incorporate DNA analysis. Methods/design A parallel groups randomised controlled trial in which smokers who are FDRs of probands with CD are randomly allocated in families to undergo one of two types of assessment of risk for developing CD based on either: i. DNA analysis, family history of CD and smoking status, or ii. Family history of CD and smoking status The primary outcome is stopping smoking for 24 hours or longer in the six months following provision of risk information. The secondary outcomes are seven-day smoking abstinence at one week and six month follow-ups. Randomisation of 470 smoking FDRs of CD probands, with 400 followed up (85%, provides 80% power to detect a difference in the primary outcome of 14% between randomised arms, at the 5% significance level. Discussion This trial provides one of the strongest tests to date of the impact of communicating DNA-based risk assessment on risk-reducing behaviour change. Specific issues regarding the choice of trial design are discussed. Trial Registration ISRCTN: ISRCTN21633644

  17. Efeito do exercício físico na percepção de satisfação de vida e função imunológica em pacientes infectados pelo HIV: Ensaio clínico não randomizado Effects of physical exercise in the perception of life satisfaction and immunological function in HIV-infected patients: Non-randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Rodrigo D. Gomes

    2010-10-01

    Full Text Available CONTEXTUALIZAÇÃO: Os estudos sobre a relação entre prática de exercícios e bem-estar psicológico de pacientes com vírus da imunodeficiência humana (HIV são raros. OBJETIVO: Investigar a influência de programa de condicionamento físico sobre a satisfação com a própria vida e sobre a função imunológica. MÉTODOS: Para tal análise, 29 pacientes soropositivos (idade: 45±2 anos; índice de massa corporal (IMC: 22,8±1,0 kg/m2; TCD4: 20,5±2,0%, foram divididos em grupo controle (GC, n=10 e grupo experimental (GE, n=19. O GE participou durante 12 semanas de programa de exercícios que combinavam exercícios aeróbios, força e flexibilidade (três vezes/semana; aeróbio-30min: carga em watts equivalente a 150bpm-PWC150; força-50min: três séries de 12 repetições em cinco exercícios a 60-80% 12 RM; flexibilidade-10min: duas séries de 30s na máxima amplitude em oito exercícios. A função imunológica foi avaliada por contagem absoluta e relativa das células TCD4 (citometria de fluxo,e a satisfação de vida, por meio do Índice de Satisfação de Vida (ISV. RESULTADOS: A análise de variância (ANOVA não identificou alteração significativa para os linfócitos TCD4 em ambos os grupos, apesar da tendência à elevação no GE (16%, p=0,19. Houve melhora significativa no ISV (≈15%, PBACKGROUND: There is a lack of research about the relationship between exercise and the psychological well-being of HIV-infected (Human Immunodeficiency Virus patients. OBJECTIVE: The objective of this study was to investigate the influence of a physical training program on life satisfaction and on the immunological function in HIV-patients. METHODS: A total of 29 HIV-seropositive patients [age: 45±2 yrs; Body Mass Index (BMI: 22.8±1.0 kg/m² ; TCD4: 20.5±2.0%] were allocated to the control (CG, n=10 and to the experimental groups (EG, n=19. The EG participated in an exercise program combining aerobic, strength, and flexibility exercises

  18. Prebiotic supplementation improves appetite control in children with overweight and obesity: a randomized controlled trial.

    Science.gov (United States)

    Hume, Megan P; Nicolucci, Alissa C; Reimer, Raylene A

    2017-02-22

    Background: Prebiotics have been shown to improve satiety in adults with overweight and obesity; however, studies in children are limited.Objective: We examined the effects of prebiotic supplementation on appetite control and energy intake in children with overweight and obesity.Design: This study was a randomized, double-blind, placebo-controlled trial. Forty-two boys and girls, ages 7-12 y, with a body mass index (BMI) of ≥85th percentile were randomly assigned to 8 g oligofructose-enriched inulin/d or placebo (maltodextrin) for 16 wk. Objective measures of appetite included energy intake at an ad libitum breakfast buffet, 3-d food records, and fasting satiety hormone concentrations. Subjective appetite ratings were obtained from visual analog scales before and after the breakfast. Children's Eating Behavior Questionnaires were also completed by caregivers.Results: Compared with placebo, prebiotic intake resulted in significantly higher feelings of fullness (P = 0.04) and lower prospective food consumption (P = 0.03) at the breakfast buffet at 16 wk compared with baseline. Compared with placebo, prebiotic supplementation significantly reduced energy intake at the week 16 breakfast buffet in 11- and 12-y-olds (P = 0.04) but not in 7- to 10-y-olds. Fasting adiponectin (P = 0.04) and ghrelin (P = 0.03) increased at 16 wk with the prebiotic compared with placebo. In intent-to-treat analysis, there was a trend for prebiotic supplementation to reduce BMI z score to a greater extent than placebo (-3.4%; P = 0.09) and a significant -3.8% reduction in per-protocol analysis (P = 0.043).Conclusions: Independent of other lifestyle changes, prebiotic supplementation in children with overweight and obesity improved subjective appetite ratings. This translated into reduced energy intake in a breakfast buffet in older but not in younger children. This simple dietary change has the potential to help with appetite regulation in children with obesity. This trial was registered at

  19. Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial

    OpenAIRE

    Kassai, Behrouz; Rabilloud, Muriel; Bernoux, Delphine; Michal, Catherine; Riche, Benjamin; Ginhoux, Tiphanie; Laudy, Valérie; Terral, Daniel; Didier-Wright, Catherine; Maire, Veronique; Dumont, Catherine; Cottancin, Gilles; Plasse, Muriel; Jeannoel, Guy-Patrick; Khoury, Jamil

    2015-01-01

    Backgrounds Fluctuation in glycemia due to hormonal changes, growth periods, physical activity, and emotions make diabetes management difficult during adolescence. Our objective was to show that a close control of patients’ self-management of diabetes by nurse-counseling could probably improve metabolic control in adolescents with type 1 diabetes. Methods We designed a multicenter, randomized controlled, parallel group, clinical trial. Seventy seven adolescents aged 12–17 years with A1C >8 % ...

  20. A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

    Science.gov (United States)

    2016-10-01

    Health Questionnaire (PHQ)- 9 Depression by Groups Transcendental Meditation Prolonged Exposure Health Education 11 Mean Change -6.0 (-7.6, -4.5...Award Number: W81XWH-12-1-0576 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in...Exposure Therapy and Education Control on PTSD in Veterans 5a. CONTRACT NUMBER W81XWH-12-1-0576 5b. GRANT NUMBER PT110413 & PT110413A 5c

  1. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

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    Ravaud Philippe

    2009-05-01

    Full Text Available Abstract Background The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Methods The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected. A standardized abstraction form was used to extract data. Results 132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke were reported as primary or secondary outcomes in 107 reports (81%. However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22% and a definition of expected adverse events was provided in 47 (36%. The length of follow-up was reported in 95 reports (72%. Assessment of adverse events by an adjudication committee was described in 46 reports (35%, and adverse events were described as being followed up for 6 months in 24% of reports (n = 32, between 7 to 12 months in 42% (n = 55 and for more than 1 year in 4% (n = 5. In 115 reports (87%, numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%. The causality of adverse events was reported in only 4 articles. Conclusion Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials Registration Trials manuscript: 5534201182098351 (T80802P

  2. Randomised controlled trials of veterinary homeopathy: characterising the peer-reviewed research literature for systematic review.

    Science.gov (United States)

    Mathie, Robert T; Hacke, Daniela; Clausen, Jürgen

    2012-10-01

    Systematic review of the research evidence in veterinary homeopathy has never previously been carried out. This paper presents the search methods, together with categorised lists of retrieved records, that enable us to identify the literature that is acceptable for future systematic review of randomised controlled trials (RCTs) in veterinary homeopathy. All randomised and controlled trials of homeopathic intervention (prophylaxis and/or treatment of disease, in any species except man) were appraised according to pre-specified criteria. The following databases were systematically searched from their inception up to and including March 2011: AMED; Carstens-Stiftung Homeopathic Veterinary Clinical Research (HomVetCR) database; CINAHL; Cochrane Central Register of Controlled Trials; Embase; Hom-Inform; LILACS; PubMed; Science Citation Index; Scopus. One hundred and fifty records were retrieved; 38 satisfied the acceptance criteria (substantive report of a clinical treatment or prophylaxis trial in veterinary homeopathic medicine randomised and controlled and published in a peer-reviewed journal), and were thus eligible for future planned systematic review. Approximately half of the rejected records were theses. Seven species and 27 different species-specific medical conditions were represented in the 38 papers. Similar numbers of papers reported trials of treatment and prophylaxis (n=21 and n=17 respectively) and were controlled against placebo or other than placebo (n=18, n=20 respectively). Most research focused on non-individualised homeopathy (n=35 papers) compared with individualised homeopathy (n=3). The results provide a complete and clarified view of the RCT literature in veterinary homeopathy. We will systematically review the 38 substantive peer-reviewed journal articles under the main headings: treatment trials; prophylaxis trials. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  3. Incorporating a Patient Dichotomous Characteristic in Cancer Phase I Clinical Trials Using Escalation with Overdose Control

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    Mourad Tighiouart

    2012-01-01

    Full Text Available We describe a design for cancer phase I clinical trials that takes into account patients heterogeneity thought to be related to treatment susceptibility. The goal is to estimate the maximum tolerated dose (MTD given patient’s specific dichotomous covariate value. The design is Bayesian adaptive and is an extension of escalation with overdose control (EWOC. We will assess the performance of this method by comparing the following designs via extensive simulations: (1 design using a covariate; patients are accrued to the trial sequentially and the dose given to a patient depends on his/her baseline covariate value, (2 design ignoring the covariate; patients are accrued to the trial sequentially and the dose given to a patient does not depend on his/her baseline covariate value, and (3 design using separate trials; in each group, patients are accrued to the trial sequentially and EWOC is implemented in each group. These designs are compared with respect to safety of the trial and efficiency of the estimates of the MTDs via extensive simulations. We found that ignoring a significant baseline binary covariate in the model results in a substantial number of patients being overdosed. On the other hand, accounting for a nonsignificant covariate in the model has practically no effect on the safety of the trial and efficiency of the estimates of the MTDs.

  4. Control charts for monitoring accumulating adverse event count frequencies from single and multiple blinded trials.

    Science.gov (United States)

    Gould, A Lawrence

    2016-12-30

    Conventional practice monitors accumulating information about drug safety in terms of the numbers of adverse events reported from trials in a drug development program. Estimates of between-treatment adverse event risk differences can be obtained readily from unblinded trials with adjustment for differences among trials using conventional statistical methods. Recent regulatory guidelines require monitoring the cumulative frequency of adverse event reports to identify possible between-treatment adverse event risk differences without unblinding ongoing trials. Conventional statistical methods for assessing between-treatment adverse event risks cannot be applied when the trials are blinded. However, CUSUM charts can be used to monitor the accumulation of adverse event occurrences. CUSUM charts for monitoring adverse event occurrence in a Bayesian paradigm are based on assumptions about the process generating the adverse event counts in a trial as expressed by informative prior distributions. This article describes the construction of control charts for monitoring adverse event occurrence based on statistical models for the processes, characterizes their statistical properties, and describes how to construct useful prior distributions. Application of the approach to two adverse events of interest in a real trial gave nearly identical results for binomial and Poisson observed event count likelihoods. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  5. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial.

    Directory of Open Access Journals (Sweden)

    2005-11-01

    Full Text Available BACKGROUND: Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled intervention trial was conducted in a general population of South Africa to test this hypothesis. METHODS AND FINDINGS: A total of 3,274 uncircumcised men, aged 18-24 y, were randomized to a control or an intervention group with follow-up visits at months 3, 12, and 21. Male circumcision was offered to the intervention group immediately after randomization and to the control group at the end of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios (RR of HIV incidence were determined with 95% CI. Protection against HIV infection was calculated as 1 - RR. The trial was stopped at the interim analysis, and the mean (interquartile range follow-up was 18.1 mo (13.0-21.0 when the data were analyzed. There were 20 HIV infections (incidence rate = 0.85 per 100 person-years in the intervention group and 49 (2.1 per 100 person-years in the control group, corresponding to an RR of 0.40 (95% CI: 0.24%-0.68%; p < 0.001. This RR corresponds to a protection of 60% (95% CI: 32%-76%. When controlling for behavioural factors, including sexual behaviour that increased slightly in the intervention group, condom use, and health-seeking behaviour, the protection was of 61% (95% CI: 34%-77%. CONCLUSION: Male circumcision provides a degree of protection against acquiring HIV infection, equivalent to what a vaccine of high efficacy would have achieved. Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa. (Preliminary and partial results were presented at the International AIDS Society 2005 Conference, on 26 July 2005, in Rio de Janeiro, Brazil..

  6. Efficacy of a multimodal analgesia protocol in total knee arthroplasty: a randomized, controlled trial.

    Science.gov (United States)

    Fu, P L; Xiao, J; Zhu, Y L; Wu, H S; Li, X H; Wu, Y L; Qian, Q R

    2010-01-01

    A total of 100 osteoarthritis patients undergoing unilateral total knee arthroplasty were randomly assigned to receive either a multimodal analgesia protocol, comprising oral celecoxib and tramadol before and after surgery and intra-articular injection of large doses of morphine, ropivacaine, adrenaline and betamethasone during surgery (trial group), or oral and intra-articular placebo (control group). All patients received patient-controlled analgesia for 48 h after surgery. Morphine consumption up to 48 h after surgery was significantly lower in the trial than in the control group. Compared with the control group, the trial group had significantly lower visual analogue scale (VAS) scores for pain at rest from 6 h to 7 days after surgery and significantly lower VAS scores during activity from 24 h to 7 days after surgery. Active straight leg raise and active 90 degrees knee flexion were achieved sooner and range of knee movement at postoperative days 1 - 15 were significantly greater in the trial group. Postoperative wound healing, infection, blood pressure, heart rate, rash, respiratory depression, urinary retention and deep vein thrombosis were similar in the two groups, but nausea and vomiting were significantly less frequent in the trial group.

  7. A new non-randomized model for analysing sensitive questions with binary outcomes.

    Science.gov (United States)

    Tian, Guo-Liang; Yu, Jun-Wu; Tang, Man-Lai; Geng, Zhi

    2007-10-15

    We propose a new non-randomized model for assessing the association of two sensitive questions with binary outcomes. Under the new model, respondents only need to answer a non-sensitive question instead of the original two sensitive questions. As a result, it can protect a respondent's privacy, avoid the usage of any randomizing device, and be applied to both the face-to-face interview and mail questionnaire. We derive the constrained maximum likelihood estimates of the cell probabilities and the odds ratio for two binary variables associated with the sensitive questions via the EM algorithm. The corresponding standard error estimates are then obtained by bootstrap approach. A likelihood ratio test and a chi-squared test are developed for testing association between the two binary variables. We discuss the loss of information due to the introduction of the non-sensitive question, and the design of the co-operative parameters. Simulations are performed to evaluate the empirical type I error rates and powers for the two tests. In addition, a simulation is conducted to study the relationship between the probability of obtaining valid estimates and the sample size for any given cell probability vector. A real data set from an AIDS study is used to illustrate the proposed methodologies.

  8. Synaptic signal streams generated by ex vivo neuronal networks contain non-random, complex patterns.

    Science.gov (United States)

    Lee, Sangmook; Zemianek, Jill M; Shultz, Abraham; Vo, Anh; Maron, Ben Y; Therrien, Mikaela; Courtright, Christina; Guaraldi, Mary; Yanco, Holly A; Shea, Thomas B

    2014-11-01

    Cultured embryonic neurons develop functional networks that transmit synaptic signals over multiple sequentially connected neurons as revealed by multi-electrode arrays (MEAs) embedded within the culture dish. Signal streams of ex vivo networks contain spikes and bursts of varying amplitude and duration. Despite the random interactions inherent in dissociated cultures, neurons are capable of establishing functional ex vivo networks that transmit signals among synaptically connected neurons, undergo developmental maturation, and respond to exogenous stimulation by alterations in signal patterns. These characteristics indicate that a considerable degree of organization is an inherent property of neurons. We demonstrate herein that (1) certain signal types occur more frequently than others, (2) the predominant signal types change during and following maturation, (3) signal predominance is dependent upon inhibitory activity, and (4) certain signals preferentially follow others in a non-reciprocal manner. These findings indicate that the elaboration of complex signal streams comprised of a non-random distribution of signal patterns is an emergent property of ex vivo neuronal networks.

  9. Role of technology in supporting quality control and treatment fidelity in a family caregiver clinical trial.

    Science.gov (United States)

    Farran, Carol J; Etkin, Caryn D; McCann, Judith J; Paun, Olimpia; Eisenstein, Amy R; Wilbur, Joellen

    2011-11-01

    This article describes how a family caregiver lifestyle physical activity clinical trial uses research technology to enhance quality control and treatment fidelity. This trial uses a range of Internet, Blaise(®) Windows-based software and Echo Server technologies to support quality control issues, such as data collection, data entry, and study management advocated by the clinical trials literature, and to ensure treatment fidelity concerning intervention implementation (i.e., design, training, delivery, receipt, and enactment) as proposed by the National Institutes of Health Behavior Change Consortium. All research staff are trained to use these technologies. Strengths of this technological approach to support quality control and treatment fidelity include the comprehensive plan, involvement of all staff, and ability to maintain accurate and timely data. Limitations include the upfront time and costs for developing and testing these technological methods, and having support staff readily available to address technological issues if they occur.

  10. Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

    Science.gov (United States)

    Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

    2014-05-01

    Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work.

  11. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention

    DEFF Research Database (Denmark)

    Ho, Tony W; Connor, Kathryn M; Zhang, Ying

    2014-01-01

    OBJECTIVE: To evaluate whether the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant might be effective for migraine prevention. METHODS: In this randomized, double-blind, placebo-controlled, multicenter trial (ClinicalTrials.gov NCT00797667), patients experiencing 3-14 migra......OBJECTIVE: To evaluate whether the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant might be effective for migraine prevention. METHODS: In this randomized, double-blind, placebo-controlled, multicenter trial (ClinicalTrials.gov NCT00797667), patients experiencing 3......-14 migraine days during a 4-week baseline were randomized to telcagepant 140 mg, telcagepant 280 mg, or placebo twice daily for 12 weeks. Efficacy was assessed by mean monthly headache days and migraine/probable migraine days (headache plus ≥ 1 associated symptom). RESULTS: The trial was terminated following...... a recommendation from the Safety Monitoring Board due to hepatotoxicity concerns. At termination, the planned 660 patients had been randomized, 656 had been treated with ≥ 1 dose of study medication, and 14 had completed the trial. The mean treatment duration was 48-50 days. Thirteen patients, all...

  12. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Chmiel C

    2014-10-01

    Full Text Available Corinne Chmiel, Oliver Senn, Thomas Rosemann, Valerio Del Prete, Claudia Steurer-Stey Institute of General Practice and Health Services Research, University of Zurich, Zurich, Switzerland Background: Inadequate blood pressure (BP control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP improves BP control and adherence with home BP measurement.Methods: In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg, and adherence with home BP measurement after 6 months.Results: One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7. BP control (treatment target <140/90 mmHg was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5. Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1Conclusion: Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months, but no significant between-group difference was

  13. Nonadherence to treatment protocol in published randomised controlled trials: a review

    Directory of Open Access Journals (Sweden)

    Dodd Susanna

    2012-06-01

    Full Text Available Abstract This review aimed to ascertain the extent to which nonadherence to treatment protocol is reported and addressed in a cohort of published analyses of randomised controlled trials (RCTs. One hundred publications of RCTs, randomly selected from those published in BMJ, New England Journal of Medicine, the Journal of the American Medical Association and The Lancet during 2008, were reviewed to determine the extent and nature of reported nonadherence to treatment protocol, and whether statistical methods were used to examine the effect of such nonadherence on both benefit and harms analyses. We also assessed the quality of trial reporting of treatment protocol nonadherence and the quality of reporting of the statistical analysis methods used to investigate such nonadherence. Nonadherence to treatment protocol was reported in 98 of the 100 trials, but reporting on such nonadherence was often vague or incomplete. Forty-two publications did not state how many participants started their randomised treatment. Reporting of treatment initiation and completeness was judged to be inadequate in 64% of trials with short-term interventions and 89% of trials with long-term interventions. More than half (51 of the 98 trials with treatment protocol nonadherence implemented some statistical method to address this issue, most commonly based on per protocol analysis (46 but often labelled as intention to treat (ITT or modified ITT (23 analyses in 22 trials. The composition of analysis sets for their benefit outcomes were not explained in 57% of trials, and 62% of trials that presented harms analyses did not define harms analysis populations. The majority of defined harms analysis populations (18 out of 26 trials, 69% were based on actual treatment received, while the majority of trials with undefined harms analysis populations (31 out of 43 trials, 72% appeared to analyse harms using the ITT approach. Adherence to randomised intervention is poorly considered

  14. Sentence retrieval for abstracts of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Chung Grace Y

    2009-02-01

    Full Text Available Abstract Background The practice of evidence-based medicine (EBM requires clinicians to integrate their expertise with the latest scientific research. But this is becoming increasingly difficult with the growing numbers of published articles. There is a clear need for better tools to improve clinician's ability to search the primary literature. Randomized clinical trials (RCTs are the most reliable source of evidence documenting the efficacy of treatment options. This paper describes the retrieval of key sentences from abstracts of RCTs as a step towards helping users find relevant facts about the experimental design of clinical studies. Method Using Conditional Random Fields (CRFs, a popular and successful method for natural language processing problems, sentences referring to Intervention, Participants and Outcome Measures are automatically categorized. This is done by extending a previous approach for labeling sentences in an abstract for general categories associated with scientific argumentation or rhetorical roles: Aim, Method, Results and Conclusion. Methods are tested on several corpora of RCT abstracts. First structured abstracts with headings specifically indicating Intervention, Participant and Outcome Measures are used. Also a manually annotated corpus of structured and unstructured abstracts is prepared for testing a classifier that identifies sentences belonging to each category. Results Using CRFs, sentences can be labeled for the four rhetorical roles with F-scores from 0.93–0.98. This outperforms the use of Support Vector Machines. Furthermore, sentences can be automatically labeled for Intervention, Participant and Outcome Measures, in unstructured and structured abstracts where the section headings do not specifically indicate these three topics. F-scores of up to 0.83 and 0.84 are obtained for Intervention and Outcome Measure sentences. Conclusion Results indicate that some of the methodological elements of RCTs are

  15. A compound herbal preparation (CHP) in the treatment of children with ADHD: a randomized controlled trial.

    Science.gov (United States)

    Katz, M; Levine, A Adar; Kol-Degani, H; Kav-Venaki, L

    2010-11-01

    Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. A randomized, double-blind, placebo-controlled trial. University-affiliated tertiary medical center. 120 children newly diagnosed with ADHD, meeting DSM-IV criteria. Random assignment to the herbal treatment group (n = 80) or control group (placebo; n = 40); 73 patients in the treatment group (91%) and 19 in the control group (48%) completed the 4-month trial. Test of Variables of Attention (TOVA) administered before and after the treatment period; overall score and 4 subscales. The treatment group showed substantial, statistically significant improvement in the 4 subscales and overall TOVA scores, compared with no improvement in the control group, which persisted in an intention-to-treat analysis. The well-tolerated CHP demonstrated improved attention, cognition, and impulse control in the intervention group, indicating promise for ADHD treatment in children.

  16. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

    DEFF Research Database (Denmark)

    Bello, Segun; Wei, Maoling; Hilden, Jørgen

    2016-01-01

    Background: Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided...... published before 1977. The studies differed considerably with regard to design, methodology and analysis. Sixteen of the 36 studies (44 %) concluded inadequate matching. When we adapted high or low thresholds for inadequate matching, the number of trials with inadequate matching was reduced to 12 (33...... to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching. Methods: Systematic review. We searched Pub...

  17. Prevention of Preterm Birth with Pessary in Singletons (PoPPS): a randomized controlled trial.

    Science.gov (United States)

    Dugoff, Lorraine; Berghella, Vincenzo; Sehdev, Harish; Mackeen, A Dhanya; Goetzl, Laura; Ludmir, Jack

    2017-09-20

    To determine if pessary use prevents preterm birth in singleton gestations with a short transvaginal ultrasound cervical length and without a prior spontaneous preterm birth. In this open-label multicenter randomized trial we enrolled asymptomatic women with singleton gestations with a transvaginal ultrasound cervical length ≤ 25 mm at 18(0) -23(6) weeks and no prior spontaneous preterm birth. Subjects were randomized to receive the Bioteque cup pessary or no pessary. Pessaries were inserted by trained maternal fetal medicine staff.. Vaginal progesterone was recommended to women with a cervical length ≤20mm. The primary outcome was preterm birth preterm birth preterm birth preterm birth preterm birth in women with singleton gestations with a short transvaginal ultrasound cervical length and without a prior spontaneous preterm birth in this small underpowered randomized controlled trial. This trial was registered on ClinicalTrials.gov, number NCT 02056652. This article is protected by copyright. All rights reserved.

  18. Effectiveness of Treadmill Training on Balance Control in Elderly People: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Soraya Pirouzi

    2014-11-01

    Full Text Available Physical exercise would improve postural stability, which is an essential factor in preventing accidental fall among the elderly population. The aim of this study is to examine the effectiveness of treadmill walking on balance improvement among the elderly people. A total of 30 community dwelling older adults with a Berg Balance Scale score of 36-48 and the ability to walk without aid were considered and divided into control (n=15 and experimental (n=15 groups. Individuals in the experimental group participated in 30 minutes of forward and backward treadmill training based on three times a week interval for a period of four weeks. Individuals in the control group were instructed to continue with their daily routine activity. Before and after training, gait speed was measured by six-minute walk test and balance ability was evaluated by Fullerton Advanced Balance Scale (FABS and Berg Balance Scale (BBS tests. Postural sway items such as the Center of Pressure (COP, average displacement and velocity were evaluated by using a force platform system. Data were collected in quiet standing, tandem position and standing on foam pads before and after intervention. After intervention, balance variables in the experimental group indicated a significant improvement in quiet standing on firm and foam surfaces, but no considerable improvement was shown in tandem position. A between-group comparison showed a significant reduction in COP velocity in the sagittal plane (P=0.030 during quiet standing and in the frontal plane (P=0.001 during standing on foam, whereas no significant reduction in COP parameters during tandem position was found. It is recommended that twelve sessions of forward and backward treadmill walk are effective in balance improvement in elderly people. Trial Registration Number: IRCT201209199440N2

  19. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP).

    Science.gov (United States)

    Allison, David B; Gadde, Kishore M; Garvey, William Timothy; Peterson, Craig A; Schwiers, Michael L; Najarian, Thomas; Tam, Peter Y; Troupin, Barbara; Day, Wesley W

    2012-02-01

    A 56-week randomized controlled trial was conducted to evaluate safety and efficacy of a controlled-release combination of phentermine and topiramate (PHEN/TPM CR) for weight loss (WL) and metabolic improvements. Men and women with class II and III obesity (BMI ≥ 35 kg/m(2)) were randomized to placebo, PHEN/TPM CR 3.75/23 mg, or PHEN/TPM CR 15/92 mg, added to a reduced-energy diet. Primary end points were percent WL and proportions of patients achieving 5% WL. Secondary end points included waist circumference (WC), systolic and diastolic blood pressure (BP), fasting glucose, and lipid measures. In the primary analysis (randomized patients with at least one postbaseline weight measurement who took at least one dose of assigned drug or placebo), patients in the placebo, 3.75/23, and 15/92 groups lost 1.6%, 5.1%, and 10.9% of baseline body weight (BW), respectively, at 56 weeks (P fasting glucose, triglycerides, total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL). The most common adverse events were paresthesia, dry mouth, constipation, dysgeusia, and insomnia. Dropout rate from the study was 47.1% for placebo patients, 39.0% for 3.75/23 patients, and 33.6% of 15/92 patients. PHEN/TPM CR demonstrated dose-dependent effects on weight and metabolic variables in the direction expected to be beneficial with no evidence of serious adverse events induced by treatment.

  20. 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

  1. Randomized, controlled trial of telcagepant over four migraine attacks

    DEFF Research Database (Denmark)

    Ho, Andrew P; Dahlöf, Carl Gh; Silberstein, Stephen D

    2010-01-01

    This study evaluated the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant (tablet formulation) for treatment of a migraine attack and across four attacks. Adults with migraine were randomized, double-blind, to telcagepant 140 mg, telcagepant 280 mg, or control treatment...... sequences to treat four moderate-to-severe migraine attacks. Control patients received placebo for three attacks and telcagepant 140 mg for one attack. Efficacy for the first attack (Attack 1) and consistency of efficacy over multiple attacks were assessed. For an individual patient, consistent efficacy...

  2. Randomized controlled trial of intravenous acetaminophen for postcesarean delivery pain control.

    Science.gov (United States)

    Altenau, Brie; Crisp, Catrina C; Devaiah, C Ganga; Lambers, Donna S

    2017-04-25

    Cesarean delivery is a common surgery in the United States, with 1.3 million performed during 2009.(1) Obstetricians must balance the growing concern with opioid abuse, dependence, and side effects with optimal postoperative pain control. Intravenous acetaminophen may represent an additional method to decrease the reliance on opioid medications and improve postoperative pain following cesarean delivery. The objective of the study was to determine whether the administration of intravenous acetaminophen following routine scheduled cesarean delivery would decrease the need for narcotic medications to control postoperative pain. This was an institutional review board-approved, double-blind, placebo-controlled, randomized trial, registered on clinicaltrials.gov (number 02046382). Women scheduled to undergo cesarean delivery with regional anesthesia at term were recruited. All perioperative and postpartum care was standardized via study order sets. Study patients were given all medications in a standardized manner receiving either acetaminophen 1000 mg intravenously or 100 mL saline (placebo) every 8 hours for 48 hours for a total of 6 doses. The pharmacy prepared intravenous acetaminophen and saline in identical administration bags labeled study drug to ensure blinding. The initial dose of study drug was given within 60 minutes of skin incision. Quantity of breakthrough and scheduled analgesic medications and self-reported pain levels on the Faces Pain Scale (0-10) before and after study drug administration were collected. Patient demographics were extracted from the chart. Power calculation determined that 45 patients per arm were required to detect a 30% reduction in postcesarean narcotic requirement with 80% power and a significance level of P = .05. A total of 133 patients were consented for the study. Twenty-nine were excluded and 104 patients completed the study: 57 received intravenous acetaminophen and 47 received placebo. There were no differences in baseline

  3. Benchmarking Controlled Trial--a novel concept covering all observational effectiveness studies.

    Science.gov (United States)

    Malmivaara, Antti

    2015-06-01

    The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals.

  4. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies

    Science.gov (United States)

    Williamson, Paula R; Gamble, Carrol; O'Connell Francischetto, Elaine; Metcalfe, Chris; Davidson, Peter; Williams, Hywel; Blazeby, Jane M

    2017-01-01

    Objectives Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or ‘progression’ criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking. This paper outlines the key issues to consider in the optimal development and review of operational progression criteria for RCTs with an internal pilot phase. Design A structured literature review and exploration of stakeholders' opinions at a Medical Research Council (MRC) Hubs for Trials Methodology Research workshop. Key stakeholders included triallists, methodologists, statisticians and funders. Results There is considerable variation in the use of progression criteria for RCTs with an internal pilot phase, although 3 common issues predominate: trial recruitment, protocol adherence and outcome data. Detailed and systematic reporting around the decision-making process for stopping, amending or proceeding to a main trial is uncommon, which may hamper understanding in the research community about the appropriate and optimal use of RCTs with an internal pilot phase. 10 top tips for the development, use and reporting of progression criteria for internal pilot studies are presented. Conclusions Systematic and transparent reporting of the design, results and evaluation of internal pilot trials in the literature should be encouraged in order to facilitate understanding in the research community and to inform future trials. PMID:28213598

  5. Systematic review of controlled trials of interventions to promote smoke alarms.

    Science.gov (United States)

    DiGuiseppi, C; Higgins, J P

    2000-05-01

    To evaluate the effects of promotion of residential smoke alarms. Electronic databases, conference proceedings, and bibliographies were systematically searched, and investigators and organisations were contacted, in order to identify controlled trials evaluating interventions designed to promote residential smoke alarms. The following were assessed: smoke alarm acquisition, ownership, and function; fires; burns; and fire related injuries. Odds ratios (OR) were estimated by meta analysis of randomised trials. A total of 26 trials were identified, of which 13 were randomised. Overall, counselling and educational interventions had only a modest effect on the likelihood of owning an alarm (OR = 1.26; 95% confidence interval (CI): 0.87 to 1.81) or having a functional alarm (OR = 1.19; 95% CI: 0.85 to 1.66). Counselling as part of primary care child health surveillance had greater effects on ownership (OR = 1.93; 95% CI: 1.04 to 3.58) and function (OR = 1. 72; 95% CI: 0.78 to 3.78). Results were sensitive to trial quality, however, and effects on fire related injuries were not reported. In two non-randomised trials, direct provision of free alarms significantly increased functioning alarms and reduced fire related injuries. Media and community education showed little benefit in non-randomised trials. Counselling as part of child health surveillance may increase smoke alarm ownership and function, but its effects on injuries are unevaluated. Community smoke alarm give away programmes apparently reduce fire related injuries, but these trials were not randomised and results must be interpreted cautiously. Further efforts to promote smoke alarms in primary care or through give away programmes should be evaluated by adequately designed randomised controlled trials measuring injury outcomes.

  6. Adherence in a pragmatic randomized controlled trial on prophylactic iron supplementation during pregnancy in Maputo, Mozambique.

    Science.gov (United States)

    Nwaru, Bright I; Salomé, Graça; Abacassamo, Fatima; Augusto, Orvalho; Cliff, Julie; Sousa, Cesar; Regushevskaya, Elena; Parkkali, Saara; Hemminki, Elina

    2015-04-01

    Assessing the level of adherence and its determinants is important in appraising the overall effectiveness of trials. The present study aimed to evaluate the extent of adherence and its determinants in a pragmatic randomized controlled trial of Fe prophylaxis during pregnancy in Maputo, Mozambique. A pragmatic randomized controlled trial. Two health centres (1° de Maio and Machava) in Maputo, Mozambique. Pregnant women (≥12 weeks' gestation, ≥18 years old, non-high-risk pregnancy; n 4326) attending prenatal care consultations at two health centres were randomized to receive routine Fe (n 2184; 60 mg ferrous sulfate plus 400 μg folic acid daily throughout pregnancy) or selective Fe (n 2142; screening and treatment for anaemia and daily intake of 1 mg folic acid). The level of adherence was 79% for having two or more visits, 53% for adequate prenatal care and 67% for complete intake of Fe/folic acid tablets during the trial. The correlation between the adherence measures ranged between 0·151 and 0·739. Adherence did not differ by trial arm, but there were centre differences in adequate prenatal visits and intake of tablets. Older women (>20 years) and those with a history of abortion were more likely to achieve greater adherence, whereas an increased number of previous births decreased the likelihood of adherence. HIV positivity decreased the likelihood of adherence in one trial centre and increased it in the other. The variation in adherence by trial centre, women's characteristics and outcome measures suggests that adherence in trials fully depends on participants' behaviour and can be increased by paying attention to contextual factors.

  7. Dronabinol in severe, enduring anorexia nervosa: A randomized controlled trial

    DEFF Research Database (Denmark)

    Andries, Alin; Frystyk, Jan; Flyvbjerg, Allan

    2013-01-01

    The evidence for pharmacological treatment of severe, longstanding anorexia nervosa (AN) is sparse and the few controlled pharmacologic studies have focused on a narrow range of drugs. The aim of the present study was to investigate the effects of treatment with a synthetic cannabinoid agonist...

  8. Mindful Walking in Psychologically Distressed Individuals: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    M. Teut

    2013-01-01

    Full Text Available Background. The aim of this randomized, controlled study was to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress. Methods. Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion or to no study intervention (waiting group. Primary outcome parameter was the difference to baseline on Cohen’s Perceived Stress Scale (CPSS after 4 weeks between intervention and control. Results. Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years to the control group. Adjusted CPSS differences after 4 weeks were −8.8 [95% CI: −10.8; −6.8] (mean 24.2 [22.2; 26.2] in the intervention group and −1.0 [−2.9; 0.9] (mean 32.0 [30.1; 33.9] in the control group, resulting in a highly significant group difference (. Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up.

  9. Osteoarthritis treatment using autologous conditioned serum after placebo: Patient considerations and clinical response in a non-randomized case series

    NARCIS (Netherlands)

    Rutgers, M.; Creemers, L.B.; Yang, K.G.A.; Raijmakers, N.J.H.; Dhert, W.J.A.; Saris, Daniël B.F.

    2015-01-01

    Background and purpose Autologous conditioned serum (ACS) is a disease-modifying drug for treatment of knee osteoarthritis, and modest superiority over placebo was reported in an earlier randomized controlled trial (RCT). We hypothesized that when given the opportunity, placebo-treated patients from

  10. Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial: A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea.

    Directory of Open Access Journals (Sweden)

    Daouda Sissoko

    2016-03-01

    Full Text Available Ebola virus disease (EVD is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high number of patients presenting simultaneously and the very high mortality rate of the disease, it was ethically unacceptable to allocate patients from within the same family or village to receive or not receive an experimental drug, using a randomization process impossible to understand by very sick patients. The other was that, in the context of rumors and distrust of Ebola treatment centers, using a randomized design at the outset might lead even more patients to refuse to seek care. Therefore, we chose to conduct a multicenter non-randomized trial, in which all patients would receive favipiravir along with standardized care. The objectives of the trial were to test the feasibility and acceptability of an emergency trial in the context of a large Ebola outbreak, and to collect data on the safety and effectiveness of favipiravir in reducing mortality and viral load in patients with EVD. The trial was not aimed at directly informing future guidelines on Ebola treatment but at quickly gathering standardized preliminary data to optimize the design of future studies.Inclusion criteria were positive Ebola virus reverse transcription PCR (RT-PCR test, age ≥ 1 y, weight ≥ 10 kg, ability to take oral drugs, and informed consent. All participants received oral favipiravir (day 0: 6,000 mg; day 1 to day 9: 2,400 mg/d. Semi-quantitative Ebola virus RT-PCR (results expressed in "cycle threshold" [Ct] and biochemistry tests were performed at day 0, day 2, day 4, end

  11. A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (the DART-AD trial.

    Directory of Open Access Journals (Sweden)

    Clive Ballard

    2008-04-01

    Full Text Available BACKGROUND: There have been increasing concerns regarding the safety and efficacy of neuroleptics in people with dementia, but there are very few long-term trials to inform clinical practice. The aim of this study was to determine the impact of long-term treatment with neuroleptic agents upon global cognitive decline and neuropsychiatric symptoms in patients with Alzheimer disease. METHODS AND FINDINGS: DESIGN: Randomised, blinded, placebo-controlled parallel two-group treatment discontinuation trial. SETTING: Oxfordshire, Newcastle and Gateshead, London and Edinburgh, United Kingdom. PARTICIPANTS: Patients currently prescribed the neuroleptics thioridazine, chlorpromazine, haloperidol trifluoperazine or risperidone for behavioural or psychiatric disturbance in dementia for at least 3 mo. INTERVENTIONS: Continue neuroleptic treatment for 12 mo or switch to an identical placebo. OUTCOME MEASURES: Primary outcome was total Severe Impairment Battery (SIB score. Neuropsychiatric symptoms were evaluated with the Neuropsychiatric Inventory (NPI. RESULTS: 165 patients were randomised (83 to continue treatment and 82 to placebo, i.e., discontinue treatment, of whom 128 (78% commenced treatment (64 continue/64 placebo. Of those, 26 were lost to follow-up (13 per arm, resulting in 51 patients per arm analysed for the primary outcome. There was no significant difference between the continue treatment and placebo groups in the estimated mean change in SIB scores between baseline and 6 mo; estimated mean difference in deterioration (favouring placebo -0.4 (95% confidence interval [CI] -6.4 to 5.5, adjusted for baseline value (p = 0.9. For neuropsychiatric symptoms, there was no significant difference between the continue treatment and placebo groups (n = 56 and 53, respectively in the estimated mean change in NPI scores between baseline and 6 mo; estimated mean difference in deterioration (favouring continue treatment -2.4 (95% CI -8.2 to 3.5, adjusted for

  12. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial

    NARCIS (Netherlands)

    Hoogendam, A.; Vries Robbé, P.F. de; Overbeke, A.J.P.M.

    2012-01-01

    BACKGROUND: Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick s

  13. Detection of movement intention from single-trial movement-related cortical potentials using random and non-random paradigms

    DEFF Research Database (Denmark)

    Aliakbaryhosseinabadi, Susan; Jiang, Ning; Vuckovic, Aleksandra

    2015-01-01

    Detection of motor intention with short latency from scalp electroencephalography (EEG) is essential for the development of brain-computer interface (BCI) systems for neuromodulation. This latency determines the temporal association between motor intention and the triggered afferent neurofeedback...

  14. The Effect of Wilderness Therapy on Adolescents' Cognitive Autonomy and Self-Efficacy: Results of a Non-Randomized Trial

    Science.gov (United States)

    Margalit, Daniella; Ben-Ari, Amichai

    2014-01-01

    Background: Adolescents participate in decision-making processes involving risky behaviors. Management of these important decisions may be promoted by enhancing adolescents' self-efficacy beliefs and cognitive autonomy. Objective: In order to elucidate the value of wilderness therapy to the successful management of decision making processes among…

  15. The Effect of Wilderness Therapy on Adolescents' Cognitive Autonomy and Self-Efficacy: Results of a Non-Randomized Trial

    Science.gov (United States)

    Margalit, Daniella; Ben-Ari, Amichai

    2014-01-01

    Background: Adolescents participate in decision-making processes involving risky behaviors. Management of these important decisions may be promoted by enhancing adolescents' self-efficacy beliefs and cognitive autonomy. Objective: In order to elucidate the value of wilderness therapy to the successful management of decision making processes among…

  16. Comparative Evaluation of Liposomal Albendazole and Tablet-Albendazole Against Hepatic Cystic Echinococcosis: A Non-Randomized Clinical Trial.

    Science.gov (United States)

    Li, Haitao; Song, Tao; Shao, Yingmei; Aili, Tuergan; Ahan, Ayifuhan; Wen, Hao

    2016-01-01

    In this study, we aimed to compare the clinical efficacy of liposomal albendazole (L-ABZ) and tablet-albendazole (T-ABZ) for the treatment of human hepatic cystic echinococcosis (CE). Sixty patients with single cyst (CE1) or daughter cyst (CE2) were included in this study and were nonrandomly divided into the L-ABZ group (n = 30, 10  mg/kg per day, p.o., b.i.d.) and T-ABZ group (n = 30, 12-20 mg/kg per day, p.o., b.i.d.), respectively. The treatment duration lasted for 6 months, during which dynamic follow-up was carried out to evaluate the clinical efficacy through calculating the total effective rates (TERs). Measurement data and numerous data were analyzed by the chi-square test. Two-sided tests were performed for all the statistical tests. In our study, 2 patients were lost in the follow-up in the L-ABZ group. One patient was lost in the follow-up in the T-ABZ group, and 1 patient was withdrawal from the study due to receiving surgery. Significant difference was identified in the 3-month TERs of L-ABZ group and T-ABZ group (33.3% vs 76.7%, P  0.05). Based on our study, both T-ABZ and L-ABZ are effective for treating human CE. The TER in the L-ABZ group is superior to that of T-ABZ.

  17. Single-port laparoscopic cholecystectomy vs standard laparoscopic cholecystectomy:A non-randomized,agematched single center trial

    Institute of Scientific and Technical Information of China (English)

    Yoen; TK; van; der; Linden; Koop; Bosscha; Hubert; A; Prins; Daniel; J; Lips

    2015-01-01

    AIM: To compare the safety of single-port laparoscopic cholecystectomies with standard four-port cholecystectomies.METHODS: Between January 2011 and December 2012 datas were gathered from 100 consecutive patients who received a single-port cholecystectomy. Patient baseline characteristics of all 100 single-port cholecystectomies were collected(body mass index, age, etc.) in a database. This group was compared with 100 age-matched patients who underwent a conventional laparoscopic cholecystectomy in the same period. Retrospectively, per- and postoperative data were added. The two groups were compared to each other using independent t-tests and χ2-tests, P values below 0.05 were considered significantly different.RESULTS: No differences were found between both groups regarding baseline characteristics. Operating time was significantly shorter in the total single-port group(42 min vs 62 min, P < 0.05); in procedures performed by surgeons the same trend was seen(45 min vs 59 min, P < 0.05). Peroperative complications between both groups were equal(3 in the single-port group vs 5 in the multiport group; P = 0.42). Although not significant less postoperative complications were seen in the single-port group compared with the multiport group(3 vs 9; P = 0.07). No statistically significant differences were found between both groupswith regard to length of hospital stay, readmissions and mortality. CONCLUSION: Single-port laparoscopic cholecystectomy has the potential to be a safe technique with a low complication rate, short in-hospital stay and comparable operating time. Single-port cholecystectomy provides the patient an almost non-visible scar while preserving optimal quality of surgery. Further prospective studies are needed to prove the safety of the single-port technique.

  18. Treatment of periocular hyperpigmentation due to lead of kohl (surma by penicillamine: A single group non-randomized clinical trial

    Directory of Open Access Journals (Sweden)

    El Safoury Omar

    2009-01-01

    Full Text Available Background: Periocular hyperpigmentation is a condition in which skin of eyelids become darker in color than the normal surrounding skin. Lead and other heavy metals produce increased pigmentation because of deposition of metal particles in the dermis and increased epidermal melanin production. Aims: This study was conducted to evaluate the dual effect of chelation therapy in treating periocular hyperpigmentation and lead toxicity. Methods: The study population consisted of nine females complaining from dark coloration of their eyelids. The nine females were continuously using kohl as eyeliner. Lead levels in conjunctiva and serum before and after D-penicillamine (D-PCN oral administration were estimated in relation to vertical, horizontal length, and degree of hyperpigmentation score. Results: Highly significant P values (0.000 were obtained as regard to the conjunctival lead levels, serum lead levels, horizontal length, and degree of darkness score before and after D-PCN therapy. A less significant P value (0.040 was recorded as regard to the vertical length. Conclusion: Regardless other causes, this study spots the light on a new concept for periocular hyperpigmentation from lead toxicity in adult females using kohl and suggests D-PCN in a low divided dose (750 mg/day for its treatment.

  19. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Giovanni E. Ferreira

    2016-01-01

    Full Text Available ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed, EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Results Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. Conclusion GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions.

  20. Eliminating bias in randomized controlled trials: importance of allocation concealment and masking.

    Science.gov (United States)

    Viera, Anthony J; Bangdiwala, Shrikant I

    2007-02-01

    Randomization in randomized controlled trials involves more than generation of a random sequence by which to assign subjects. For randomization to be successfully implemented, the randomization sequence must be adequately protected (concealed) so that investigators, involved health care providers, and subjects are not aware of the upcoming assignment. The absence of adequate allocation concealment can lead to selection bias, one of the very problems that randomization was supposed to eliminate. Authors of reports of randomized trials should provide enough details on how allocation concealment was achieved so the reader can determine the likelihood of success. Fortunately, a plan of allocation concealment can always be incorporated into the design of a randomized trial. Certain methods minimize the risk of concealment failing more than others. Keeping knowledge of subjects' assignment after allocation from subjects, investigators/health care providers, or those assessing outcomes is referred to as masking (also known as blinding). The goal of masking is to prevent ascertainment bias. In contrast to allocation concealment, masking cannot always be incorporated into a randomized controlled trial. Both allocation concealment and masking add to the elimination of bias in randomized controlled trials.

  1. Quality of reporting of chemotherapy compliance in randomized controlled trials of breast cancer treatment.

    Science.gov (United States)

    Altwairgi, Abdullah K; Alfakeeh, Ali H; Hopman, Wilma M; Parulekar, Wendy R

    2015-06-01

    The Consolidated Standards of Reporting Trials statement requires detailed reporting of interventions for randomized controlled trials. We hypothesized that there was variable reporting of chemotherapy compliance in published randomized controlled trials in breast cancer, and therefore surveyed the literature to assess this parameter and determine the study characteristics associated with reporting quality. Published Phase III randomized controlled trials (January 2005-December 2011; English language) evaluating chemotherapy in breast cancer were identified through a systematic literature search. Articles scored 1 point each for reporting of the four measures: number of chemotherapy cycles, dose modification, early treatment discontinuation and relative dose intensity. Logistic regression identified study characteristics associated with reporting quality score of ≥ 2. Of the 115 eligible randomized controlled trials, 79 (69%) were published in high-impact journals, 66 (57%) were published since 2008, 43 (37%) reported advanced-stage disease and 37 (32%) were industry sponsored. Relative dose intensity, number of cycles, dose modification and early treatment discontinuation were reported in 70 (61%), 53 (46%), 65 (57%) and 81 (70%) articles, respectively. Eighty-two (71%) articles showed a quality score of ≥ 2; 25 (22%) articles reported all four compliance measures. Articles published since 2008 (P = 0.035) and those reporting advanced-stage disease (P < 0.001) showed significantly higher quality of compliance. Our results demonstrate variable reporting of chemotherapy compliance in published randomized controlled trials with a modest improvement noted in recent years. Incorporating standards for reporting chemotherapy compliance in scientific guidelines or the journal peer review process may decrease the variability and improve the quality of reporting. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email

  2. Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial.

    Science.gov (United States)

    Boutron, Isabelle; Altman, Douglas G; Hopewell, Sally; Vera-Badillo, Francisco; Tannock, Ian; Ravaud, Philippe

    2014-12-20

    We aimed to assess the impact of spin (ie, reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results) on the interpretation of results of abstracts of randomized controlled trials (RCTs) in the field of cancer. We performed a two-arm, parallel-group RCT. We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion. Two versions of these abstracts were used-the original with spin and a rewritten version without spin. Participants were clinician corresponding authors of articles reporting RCTs, investigators of trials, and reviewers of French national grants. The primary outcome was clinicians' interpretation of the beneficial effect of the experimental treatment (0 to 10 scale). Participants were blinded to study hypothesis. Three hundred clinicians were randomly assigned using a Web-based system; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin. For abstracts with spin, the experimental treatment was rated as being more beneficial (mean difference, 0.71; 95% CI, 0.07 to 1.35; P = .030), the trial was rated as being less rigorous (mean difference, -0.59; 95% CI, -1.13 to 0.05; P = .034), and clinicians were more interested in reading the full-text article (mean difference, 0.77; 95% CI, 0.08 to 1.47; P = .029). There was no statistically significant difference in the clinicians' rating of the importance of the study or the need to run another trial. Spin in abstracts can have an impact on clinicians' interpretation of the trial results. © 2014 by American Society of Clinical Oncology.

  3. Clinical significance of 'cardiometabolic memory': a systematic review of randomized controlled trials.

    Science.gov (United States)

    Itoh, Hiroshi; Kurihara, Isao; Miyashita, Kazutoshi; Tanaka, Masami

    2017-06-01

    'Cardiometabolic memory' has been proposed based on clinical evidence to explain how, even after the cessation of a clinical trial, the superiority of one treatment over the outcome persists. To understand the cardiometabolic memory phenomenon, we performed a systematic review of randomized controlled trials (RCTs) using PubMed in August 2016. The search terms 'randomized controlled trial', 'post-trial follow-up' and 'diabetes, hypertension or dyslipidemia' were used, and articles published after the year 2000 were searched. We judged the memory phenomenon to be positive when the cardiovascular outcome at the end of the post-trial follow-up period in the intervention group was significantly superior even though the favorable control of a risk factor (blood glucose, blood pressure or lipid level) during the trial period was lost after the cessation of the intervention. Among 907 articles retrieved in the initial screening, 21 articles were judged as describing a positive memory phenomenon. Eight, six and seven of the articles concerned diabetes, hypertension and dyslipidemia, respectively. Transient intensive glucose lowering rather easily induced memory for the suppression of diabetic microangiopathies, while memory for the suppression of macroangiopathies tended to be first evident in the post-trial follow-up period. Transient intensive blood pressure lowering was generally effective in the formation of memory for the suppression of cardiovascular events and had an especially strong impact on risk reduction of chronic heart failure. Transient intensive LDL cholesterol lowering clearly had a long-term beneficial effect on risk reduction of cardiovascular events. Our systematic review revealed the clinical relevance of cardiometabolic memory.

  4. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

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