Helmerhorst Frans M
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.
Ford, Julian D.; Steinberg, Karen L.; Hawke, Josephine; Levine, Joan; Zhang, Wanli
Posttraumatic stress disorder (PTSD) is prevalent in youth involved in delinquency, but it is often not effectively treated. A randomized clinical trial was conducted comparing the outcomes of an emotion regulation therapy (Trauma Affect Regulation: Guide for Education and Therapy, or TARGET) with a relational supportive therapy (Enhanced…
Wetzels, R.V.; Wensing, M.J.P.; Weel, C. van; Grol, R.P.T.M.
OBJECTIVE: To evaluate the effects of a programme to enhance the involvement of older patients in their consultations in general practice. DESIGN: Cluster randomized trial, in which data was collected from different cohorts. SETTING AND PARTICIPANTS: Twenty-five general practices in the south-east
Langston, Anne L; McCallum, Marilyn; Campbell, Marion K; Robertson, Clare; Ralston, Stuart H
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.
Guydish, Joseph; Chan, Monica; Bostrom, Alan; Jessup, Martha; Davis, Thomas; Marsh, Cheryl
This paper reports findings from a clinical trial of a probation case management (PCM) intervention for drug-involved women offenders. Participants were randomly assigned to either PCM (n=92) or standard probation (n=91), and followed for 12 months using measures of substance abuse, psychiatric symptoms, social support and service utilization. Arrest data were collected from administrative datasets. The sample (N=183) included mostly African American (57%) and White (20%) women, with a mean age of 34.7 (SD = 9.2) and mean education of 11.6 years (SD = 2.1). Cocaine and heroin were the most frequently reported drugs of abuse, 86% reported prior history of incarceration, and 74% had children. Women assigned to both PCM and standard probation showed change over time in the direction of clinical improvement on 7 of 10 outcomes measured. However, changes observed for the PCM group were no different than those observed for the standard probation group. Higher levels of case management, drug abuse treatment, and probationary supervision may be required to achieve improved outcomes in this population. PMID:21464888
Elavsky, Steriani; McAuley, Edward
To examine the effects of walking and yoga on multidimensional self-esteem and roles played by self-efficacy, body composition, and physical activity (PA) in changes in esteem. Four-month randomized controlled exercise trial with three arms: walking, yoga, and control. Previously low-active middle-aged women (n=164; M age = 49.9; SD = 3.6). Structured and supervised walking program meeting three times per week for I hour and supervised yoga program meeting twice per week for 90 minutes. Body composition, fitness assessment, and battery of psychologic measures. Panel analysis within a structural equation modeling framework using Mplus 3.0. The walking and yoga interventions failed to enhance global or physical self-esteem but improved subdomain esteem relative to physical condition and strength (for walking) and body attractiveness (for both walking and yoga). Over time the effects of PA, self-efficacy, and body fat on changes in physical self-esteem and global esteem were mediated by changes in physical condition and body attractiveness subdomain esteem. Women reporting greater levels of self-efficacy and PA with lower body fat also reported greater enhancements in subdomain esteem. These results provide support for the hierarchic and multidimensional nature of self-esteem and indicate that middle-aged women may enhance certain aspects of physical self-esteem by participating in PA.
Vasilenko, Sara A; Piper, Megan E; Lanza, Stephanie T; Liu, Xiaoyu; Yang, Jingyun; Li, Runze
Researchers have increasingly begun to gather ecological momentary assessment (EMA) data on smoking, but new statistical methods are necessary to fully unlock information from such data. In this paper, we use a new technique, the logistic time-varying effect model (logistic TVEM), to examine the odds of smoking in the 2 weeks after a quit attempt. Data are from a subsample of participants from a randomized, placebo-controlled trial of smoking cessation pharmacotherapies who achieved initial abstinence (N = 1,106, 58% female). Participants completed up to 4 EMA assessments per day during the 2 weeks after their quit day. Predictors include baseline nicotine dependence, EMA measures of craving and negative affect, and whether an individual was assigned to a placebo, monotherapy, or combination therapy condition. Time-varying effects of these predictors were estimated using logistic TVEM. Cravings were a significant predictor of smoking throughout the entire 2 weeks postquit, whereas the effect of baseline dependence became nonsignificant by the second week, and the effect of negative affect increased over time. Individuals in the monotherapy and combination therapy conditions had decreased odds of smoking compared with placebo in the first week postquit, but these differences were nonsignificant in the second week. Findings suggest that pharmacotherapies are more effective compared with placebo earlier in a quit attempt, when the effect of baseline nicotine dependence on smoking is stronger, whereas the effect of craving and negative affect increased over time. Future cessation therapies may be more successful by providing additional support in the second week after quit attempt.
Herman, Keith C.; Reinke, Wendy M.
For children with the most serious and persistent academic and behavior problems, parent involvement in education, particularly teacher perceptions of involvement, is essential to avert their expected long-term negative outcomes. Despite the widespread interest in and perceived importance of parent involvement in education, however, few…
Giugliani, Elsa Regina Justo; Nunes, Leandro Meirelles; Issler, Roberto Mário Silveira; Santo, Lilian Cordova do Espírito; Oliveira, Luciana Dias de
To assess the impact of an intervention for teenage mothers with the involvement of maternal grandmothers on the prevalence of pacifier use in the first six months of life. This randomized clinical trial involved 323 teenage mothers, allocated to four groups: intervention with teenagers only, intervention with teenagers and their mothers, and respective controls. Six breastfeeding counseling sessions, including the recommendation to avoid the use of a pacifier, were delivered at the maternity ward and subsequently at the teenagers' homes, at seven, 15, 30, 60, and 120 days postpartum. Data on infant feeding and pacifier use were collected monthly by interviewers blinded to group allocation. The impact of the intervention was measured by comparing survival curves for pacifier use in the first six months of life and mean time to pacifier introduction. The intervention had a significant impact on reducing pacifier use only in the group in which grandmothers were involved. In this group, the intervention delayed by 64 days the introduction of a pacifier (21-85 days), compared to 25 days in the group without the participation of grandmothers (65-90 days). The intervention reduced pacifier use in the first six months of life and delayed its introduction until beyond the first month when grandmothers were involved. The intervention did not have a significant impact when only teenage mothers were involved. Copyright © 2018 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.
Full Text Available Introduction With the increase in women's employment and change in attitudes towards father’s role in family, father involvement in infant care can indirectly influence the physical health and well being of infant and mother. Materials and Methods This randomized clinical trial was performed on 150 qualified pregnant women and husbands. During the 35-37 weeks of pregnancy, fathers in fathers’ training group and couples in couples’ training group, participated in two training sessions of healthy infant caring. Fathers in control group received no training and mothers in all three groups received the routine pregnancy training and care. At the end of 4 and 8 weeks after birth, the involvement rate of fathers in infant care questioners were completed by mothers in all three groups. Then, the data were analyzed using Analysis of variance (ANOVA and SPSS software. Results The total amount of involvement was calculated 55.77 for the fourth weekand 62.64 for the eigth week. The average of total involvement rate and three dimensions of direct father-child interaction, accessibility and responsibility and providing financial resources in two training groups comparing with that in control group, indicated a significant difference (p≤0.05. Conclusion Training the fathers regarding the infant care led to an increase in the fathers’ involvement dimensions in infant care. Thus, paternal training of this educational program should be considered in pregnancy care programs.
Lam, Shui-fong; Chow-Yeung, Kamfung; Wong, Bernard P. H.; Lau, Kwok Kiu; Tse, Shuk In
A paired reading program was implemented for 195 Hong Kong preschoolers (mean age = 4.7 years) and their parents from families with a wide range of family income. The preschoolers were randomly assigned to experimental or waitlist control groups. The parents in the experimental group received 12 sessions of school-based training on paired reading…
Schmitt, Joachim; Lindner, Nathalie; Reuss-Borst, Monika; Holmberg, Hans-Christer; Sperlich, Billy
To compare the effects of a 3-week multimodal rehabilitation involving supervised high-intensity interval training (HIIT) on female breast cancer survivors with respect to key variables of aerobic fitness, body composition, energy expenditure, cancer-related fatigue, and quality of life to those of a standard multimodal rehabilitation program. A randomized controlled trial design was administered. Twenty-eight women, who had been treated for cancer were randomly assigned to either a group performing exercise of low-to-moderate intensity (LMIE; n = 14) or a group performing high-intensity interval training (HIIT; n = 14) as part of a 3-week multimodal rehabilitation program. No adverse events related to the exercise were reported. Work economy improved following both HIIT and LMIE, with improved peak oxygen uptake following LMIE. HIIT reduced mean total body fat mass with no change in body mass, muscle or fat-free mass (best P cancer-related fatigue. This randomized controlled study demonstrates that HIIT can be performed by female cancer survivors without adverse health effects. Here, HIIT and LMIE both improved work economy, quality of life and cancer-related fatigue, body composition or energy expenditure. Since the outcomes were similar, but HIIT takes less time, this may be a time-efficient strategy for improving certain aspects of the health of female cancer survivors. © 2016 The Authors. Physiological Reports published by Wiley Periodicals, Inc. on behalf of the American Physiological Society and The Physiological Society.
Okuyemi Kolawole S
Full Text Available Abstract Background African Americans experience significant tobacco-related health disparities despite the fact that over half of African American smokers are light smokers (use ≤10 cigarettes per day. African Americans have been under-represented in smoking cessation research, and few studies have evaluated treatment for light smokers. This paper describes the study design, measures, and baseline characteristics from Kick It at Swope III (KIS-III, the first treatment study of bupropion for African American light smokers. Methods Five hundred forty African American light smokers were randomly assigned to receive bupropion (150mg bid (n = 270 or placebo (n = 270 for 7 weeks. All participants received written materials and health education counseling. Participants responded to survey items and provided blood samples for evaluation of phenotype and genotype of CYP2A6 and CYP2B6 enzymes involved in nicotine and bupropion metabolism. Primary outcome was cotinine-verified 7-day point prevalence smoking abstinence at Week 26 follow-up. Results Of 2,628 individuals screened, 540 were eligible, consented, and randomized to treatment. Participants had a mean age of 46.5 years and 66.1% were women. Participants smoked an average of 8.0 cigarettes per day, had a mean exhaled carbon monoxide of 16.4ppm (range 1-55 and a mean serum cotinine of 275.8ng/ml. The mean Fagerström Test for Nicotine Dependence was 3.2, and 72.2% of participants smoked within 30 minutes of waking. The average number of quit attempts in the past year was 3.7 and 24.2% reported using pharmacotherapy in their most recent quit attempt. Motivation and confidence to quit were high. Conclusion KIS-III is the first study designed to examine both nicotine and bupropion metabolism, evaluating CYP2A6 and CYP2B6 phenotype and genotype in conjunction with psychosocial factors, in the context of treatment of African American light smokers. Of 1629 smokers screened for study participation, only
Cox, Lisa Sanderson; Faseru, Babalola; Mayo, Matthew S; Krebill, Ron; Snow, Tricia S; Bronars, Carrie A; Nollen, Nicole L; Choi, Won S; Okuyemi, Kolawole S; Salzman, Gary A; Benowitz, Neal L; Tyndale, Rachel F; Ahluwalia, Jasjit S
African Americans experience significant tobacco-related health disparities despite the fact that over half of African American smokers are light smokers (use ≤ 10 cigarettes per day). African Americans have been under-represented in smoking cessation research, and few studies have evaluated treatment for light smokers. This paper describes the study design, measures, and baseline characteristics from Kick It at Swope III (KIS-III), the first treatment study of bupropion for African American light smokers. Five hundred forty African American light smokers were randomly assigned to receive bupropion (150 mg bid) (n = 270) or placebo (n = 270) for 7 weeks. All participants received written materials and health education counseling. Participants responded to survey items and provided blood samples for evaluation of phenotype and genotype of CYP2A6 and CYP2B6 enzymes involved in nicotine and bupropion metabolism. Primary outcome was cotinine-verified 7-day point prevalence smoking abstinence at Week 26 follow-up. Of 2,628 individuals screened, 540 were eligible, consented, and randomized to treatment. Participants had a mean age of 46.5 years and 66.1% were women. Participants smoked an average of 8.0 cigarettes per day, had a mean exhaled carbon monoxide of 16.4 ppm (range 1-55) and a mean serum cotinine of 275.8 ng/ml. The mean Fagerström Test for Nicotine Dependence was 3.2, and 72.2% of participants smoked within 30 minutes of waking. The average number of quit attempts in the past year was 3.7 and 24.2% reported using pharmacotherapy in their most recent quit attempt. Motivation and confidence to quit were high. KIS-III is the first study designed to examine both nicotine and bupropion metabolism, evaluating CYP2A6 and CYP2B6 phenotype and genotype in conjunction with psychosocial factors, in the context of treatment of African American light smokers. Of 1629 smokers screened for study participation, only 18 (1.1%) were ineligible to participate in the study
Full Text Available Abstract Background The lungs are involved in up to 70% of cases of leptospirosis. In the more severe forms-bleeding from the lungs and acute respiratory distress syndrome-the lethality is high. The treatment proposed for leptospirotic pneumonitis includes just care for patients in critical condition. Clinical and experimental studies point to the involvement of immunological mechanisms in the physiopathology of lung damage caused by leptospirosis. The aim of this study is to evaluate pulse treatment with methylprednisolone × placebo for leptospirotic pneumonitis. Study design This is a randomized double-blind clinical trial to test the efficacy of pulse treatment with methylprednisolone in patients with leptospirotic pneumonitis, compared with a placebo. The patients are recruited from three hospitals in the city of Recife, in the Brazilian State of Pernambuco. The exclusion criteria include patients aged under 15 years, a history of hypersensitivity to the use of corticosteroids, the presence of active infection of fungal, tuberculous or bacterial origin apart from the infection by leptospira itself, the presence of hemoconcentration or atypical lymphocyte count on admission to hospital, the presence of co-morbidities that could be responsible for the radiological and gasometric alterations used to diagnose leptospirotic pneumonitis, evidence of recent cranial trauma, neurosurgery, peptic ulcer, and participation in another clinical trial. The patients are followed until they are discharged from hospital or die. The intervention consists of endovenous pulse treatment with 1 g methylprednisolone for three consecutive days in the study group and a placebo in the control group. The primary end-point is mortality from leptospirotic pneumonitis. The secondary end-points are: evolution of lung disease; the occurrence of nosocomial respiratory infection; duration of mechanical ventilation; duration of intensive care unit (ICU stay; duration of
Weiss Stephen M
Full Text Available Abstract Background Despite the availability of a dual therapy treatment protocol and infant feeding guidelines designed to prevent mother to child transmission (PMTCT of HIV, of the over 1 million babies born in South Africa each year, only 70% of those born to HIV positive mothers receive dual therapy. Similar to other resource-poor nations facing the integration of PMTCT into routine pregnancy and infant care, efforts in South Africa to scale up PMTCT and reduce transmission to Methods/Design This study proposes to evaluate the impact of combining two evidence-based interventions: a couple's risk reduction intervention with an evidence based medication adherence intervention to enhance male participation in combination with improving medication and PMTCT adherence in antenatal clinics to increase PMTCT overall reach and effectiveness. The study will use a group-randomized design, recruiting 240 couples from 12 clinics. Clinics will be randomly assigned to experimental and control conditions and effectiveness of the combined intervention to enhance PMTCT as well as reduce antenatal seroconversion by both individuals and clinics will be examined. Discussion Shared intervention elements may decrease sexual risk and enhance PMTCT uptake, e.g., increased male participation, enhanced communication, HIV counselling and testing, adherence, serostatus disclosure, suggest that a combined sexual risk reduction and adherence intervention plus PMTCT can increase male participation, increase couples' communication and encourage adherence to the PMTCT process. The findings will impact public health and will enable the health ministry to formulate policy related to male involvement in PMTCT, which will result in PMTCT. Trial registration PACTR201109000318329
Lloréns, Roberto; Gil-Gómez, José-Antonio; Alcañiz, Mariano; Colomer, Carolina; Noé, Enrique
To study the clinical effectiveness and the usability of a virtual reality-based intervention compared with conventional physical therapy in the balance recovery of individuals with chronic stroke. Randomized controlled trial. Outpatient neurorehabilitation unit. A total of 20 individuals with chronic stroke. The intervention consisted of 20 one-hour sessions, five sessions per week. The experimental group combined 30 minutes with the virtual reality-based intervention with 30 minutes of conventional training. The control group underwent one hour conventional therapy. Balance performance was assessed at the beginning and at the end of the trial using the Berg Balance Scale, the balance and gait subscales of the Tinetti Performance-Oriented Mobility Assessment, the Brunel Balance Assessment, and the 10-m Walking Test. Subjective data of the virtual reality-based intervention were collected from the experimental group, with a feedback questionnaire at the end of the trial. The results revealed a significant group-by-time interaction in the scores of the Berg Balance Scale (p Virtual reality interventions can be an effective resource to enhance the improvement of balance in individuals with chronic stroke. © The Author(s) 2014.
Petersen, Mette K; Andersen, Karen Vestergaard; Andersen, Niels T
BACKGROUND: Although the randomized controlled trial (RCT) is regarded as the gold standard for evaluation of the effect of an intervention, its external validity has been questioned. RCTs cannot be expected to produce results that are directly relevant to all patients and all settings, but they ......BACKGROUND: Although the randomized controlled trial (RCT) is regarded as the gold standard for evaluation of the effect of an intervention, its external validity has been questioned. RCTs cannot be expected to produce results that are directly relevant to all patients and all settings......, but they should at least allow patients and clinicians to judge to whom trial results can reasonably be applied. We assessed the external validity of an RCT investigating the efficacy of a fast-track program after total hip replacement. METHODS: 130 patients were identified as potential participants.18 patients...... were excluded, 33 enrolled patients declined to participate, and 79 patients were enrolled and randomized. We studied the distribution of preoperative characteristics and postoperative clinical variables in these 3 groups. RESULTS: A significant difference was found in both preoperative characteristics...
Racadot, Severine; Mercier, Mariette; Dussart, Sophie; Dessard-Diana, Bernadette; Bensadoun, Rene-Jean; Martin, Michel; Malaurie, Emmanuelle; Favrel, Veronique; Housset, Martin; Durdux, Catherine; Journel, Catherine; Calais, Gilles; Huet, Jocelyne; Pillet, Gerard; Hennequin, Christophe; Haddad, Elias; Diana, Christian; Blaska-Jaulerry, Brigitte; Henry-Amar, Michel; Gehanno, Pierre
Background and purpose: Post-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement. Materials and methods: The study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54-72 Gy, 30-40 fractions, 6-8 weeks) or identical treatment plus concomitant Carboplatin (50 mg/m 2 administered by IV infusion twice weekly). Results: Between February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92-119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61-0.84) in the combined treatment group and 68% (95% CI: 0.57-0.80) in the radiotherapy group (p = 0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69-1.60; p = 0.81). Conclusions: Twice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers
Lee, Joshua D; Friedmann, Peter D; Boney, Tamara Y; Hoskinson, Randall A; McDonald, Ryan; Gordon, Michael; Fishman, Marc; Chen, Donna T; Bonnie, Richard J; Kinlock, Timothy W; Nunes, Edward V; Cornish, James W; O'Brien, Charles P
Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. This 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement. The XR-NTX arm receives 6 monthly XR-NTX injections at Medical Management visits; the TAU group receives referrals to available community treatment options. Assessments occur every 2 weeks during a 24-week treatment phase and at 12- and 18-month follow-ups. The primary outcome is a relapse event, defined as either self-report or urine toxicology evidence of ≥10 days of opioid use in a 28-day (4 week) period, with a positive or missing urine test counted as 5 days of opioid use. We describe the rationale, specific aims, and design of the study. Alternative design considerations and extensive secondary aims and outcomes are discussed. XR-NTX is a potentially important treatment and relapse prevention option among persons with opioid dependence and CJS involvement. ClinicalTrials.gov: NCT00781898. Copyright © 2015 Elsevier Inc. All rights reserved.
Mullins, Sharon M; Suarez, Mariann; Ondersma, Steven J; Page, Melanie C
Previous studies have supported the efficacy of Motivational Interviewing (MI) in increasing treatment engagement and retention among people with substance abuse disorders. However, few studies have assessed the impact of MI with coerced populations, particularly women referred to drug abuse treatment by child welfare due to prenatal drug use. Seventy-one such women who used drugs during pregnancy were randomly assigned to either receive three MI sessions or to watch two educational videos and participate in a home visit. Treatment retention group attendance and random urine analysis results were evaluated in these women during the first 8 weeks of treatment. No differences were found between the two conditions on these variables. Possible reasons for these negative findings are discussed, as are ideas for future research with coerced populations.
Tabei, Isao; Tsuchida, Shigeru; Akashi, Tetsuro; Ookubo, Katsuichiro; Hosoda, Satoru; Furukawa, Yoshiyuki; Tanabe, Yoshiaki; Tamura, Yoshiko
The initial complications associated with infusion of enteral nutrition (EN) for clinical and nutritional care are vomiting, aspiration pneumonia, and diarrhea. There are many recommendations to prevent these complications. A novel method involving a viscosity-regulating pectin solution has been demonstrated. In Japan, this method along with the other so-called "semi-solid EN" approaches has been widely used in practice. However, there has been no randomized clinical trial to prove the efficiency and safety of a viscosity-regulating pectin solution in EN management. Therefore, we planned and initiated a multicenter randomized controlled trial to determine the efficiency and safety. This study included 34 patients from 7 medical institutions who participated. Institutional review board (IRB) approval was obtained from all participating institutions. Patients who required EN management were enrolled and randomly assigned to the viscosity regulation of enteral feeding (VREF) group and control group. The VREF group (n = 15) was managed with the addition of a viscosity-regulating pectin solution. The control group (n = 12) was managed with conventional EN administration, usually in a gradual step-up method. Daily clinical symptoms of pneumonia, fever, vomiting, and diarrhea; defecation frequency; and stool form were observed in the 2 week trial period. The dose of EN and duration of infusion were also examined. A favorable trend for clinical symptoms was noticed in the VREF group. No significant differences were observed in episodes of pneumonia, fever, vomiting, and diarrhea between the 2 groups. An apparent reduction in infusion duration and hardening of stool form were noted in the VREF group. The novel method involving a viscosity-regulating pectin solution with EN administration can be clinically performed safely and efficiently, similar to the conventional method. Moreover, there were benefits, such as improvement in stool form, a short time for EN infusion
Christoff, Adriana de Oliveira; Boerngen-Lacerda, Roseli
The prevalence of alcohol and other drug use is high among college students. Reducing their consumption will likely be beneficial for society as a whole. Computer and web-based interventions are promising for providing behaviorally based information. The present study compared the efficacy of three interventions (computerized screening and motivational intervention [ASSIST/MBIc], non-computerized screening and motivational intervention [ASSIST/MBIi], and screening only [control]) in college students in Curitiba, Brazil. A convenience sample of 458 students scored moderate and high risk on the ASSIST. They were then randomized into the three arms of the randomized controlled trial (ASSIST/MBIc, ASSIST/MBIi [interview], and assessment-only [control]) and assessed at baseline and 3 months later. The ASSIST involvement scores decreased at follow-up compared with baseline in the three groups, suggesting that any intervention is better than no intervention. For alcohol, the specific involvement scores decreased to a low level of risk in the three groups and the MBIc group showed a positive outcome compared with control, and the scores for each question were reduced in the two intervention groups compared to baseline. For tobacco, involvement scores decreased in the three groups, but they maintained moderate risk. For marijuana, a small positive effect was observed in the ASSIST/MBIi and control groups. The ASSIST/MBIc may be a good alternative to interview interventions because it is easy to administer, students frequently use such computer-based technologies, and individually tailored content can be delivered in the absence of a counselor. Copyright © 2015 Elsevier Ltd. All rights reserved.
Østervig, R M; Sonne, A; Rasmussen, L S
the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...
Yuan, Yin; Gao, Junye; Zang, Jinfeng; Zhang, Chi; Yang, Xingye; Chen, Xi; Zhou, Hongbing
The purpose of the current study was to compare pressure changes in the sphincter of Oddi (SO) and stone recurrence after surgery in patients with choledocholithiasis who underwent laparoscopic common bile duct exploration during laparoscopic cholecystectomy (LC) or endoscopic sphincterotomy (EST) with LC, which may provide clinical evidence for choledocholithiasis patients to choose the appropriate surgical approach. Fifty-one patients with choledocholithiasis were randomized to the EST/LC (group A 26 cases) or laparoscopic common bile duct exploration during LC group (group B 25 cases). We performed SO manometry during surgery and 3 months postoperatively on all patients. In addition, the duodenobiliary reflux test was performed during the third month postoperatively. All patients were followed for 24 to 30 months. In group A, the SO basal and contraction pressures were 30.88±16.11 and 77.46±23.62 mm Hg intraoperatively and 10.34±10.27 and 45.65±24.77 mm Hg 3 months postoperatively, respectively. In group B, the SO basal and contraction pressures were 27.80±15.88 and 73.96±23.99 mm Hg intraoperatively and 15.43±7.36 and 59.56±22.61 mm Hg 3 months postoperatively, respectively. During the third month postoperatively, duodenobiliary reflux was demonstrated in 16 of 26 and 7 of 25 patients in groups A and B, respectively (P<0.05). During follow-up, the stone recurrence rates were 6 of 26 in group A and 1 of 25 in group B (P<0.05). After EST, the SO basal and contraction pressures decreased, and the duodenobiliary reflux and stone recurrence rates increased. Thus, EST should be selected with care.
Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.
Ferragut-Garcías, Alejandro; Plaza-Manzano, Gustavo; Rodríguez-Blanco, Cleofás; Velasco-Roldán, Olga; Pecos-Martín, Daniel; Oliva-Pascual-Vaca, Jesús; Llabrés-Bennasar, Bartomeu; Oliva-Pascual-Vaca, Ángel
To evaluate the effects of a protocol involving soft tissue techniques and/or neural mobilization techniques in the management of patients with frequent episodic tension-type headache (FETTH) and those with chronic tension-type headache (CTTH). Randomized, double-blind, placebo-controlled before and after trial. Rehabilitation area of the local hospital and a private physiotherapy center. Patients (N=97; 78 women, 19 men) diagnosed with FETTH or CTTH were randomly assigned to groups A, B, C, or D. (A) Placebo superficial massage; (B) soft tissue techniques; (C) neural mobilization techniques; (D) a combination of soft tissue and neural mobilization techniques. The pressure pain threshold (PPT) in the temporal muscles (points 1 and 2) and supraorbital region (point 3), the frequency and maximal intensity of pain crisis, and the score in the Headache Impact Test-6 (HIT-6) were evaluated. All variables were assessed before the intervention, at the end of the intervention, and 15 and 30 days after the intervention. Groups B, C, and D had an increase in PPT and a reduction in frequency, maximal intensity, and HIT-6 values in all time points after the intervention as compared with baseline and group A (P<.001 for all cases). Group D had the highest PPT values and the lowest frequency and HIT-6 values after the intervention. The application of soft tissue and neural mobilization techniques to patients with FETTH or CTTH induces significant changes in PPT, the characteristics of pain crisis, and its effect on activities of daily living as compared with the application of these techniques as isolated interventions. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
ter Veer, Emil; van Kleef, Jessy Joy; Sprangers, Mirjam A. G.; Haj Mohammad, Nadia; van Oijen, Martijn G. H.; van Laarhoven, Hanneke W. M.
Health-related quality of life (HRQoL) assessments are increasingly incorporated into oncological randomized controlled trials (RCTs). The quality of HRQoL reporting in RCTs concerning palliative systemic treatment for advanced esophagogastric cancer is currently unknown. Therefore, we conducted a
Kjaergard, L L; Nikolova, D; Gluud, C
Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...
Yasutake, Kenichiro; Miyoshi, Emiko; Misumi, Yukiko; Kajiyama, Tomomi; Fukuda, Tamami; Ishii, Taeko; Moriguchi, Ririko; Murata, Yusuke; Ohe, Kenji; Enjoji, Munechika; Tsuchihashi, Takuya
The present study aimed to evaluate salt-reduction education using a self-monitoring urinary salt-excretion device. Parallel, randomized trial involving two groups. The following parameters were checked at baseline and endline of the intervention: salt check sheet, eating behaviour questionnaire, 24 h home urine collection, blood pressure before and after urine collection. The intervention group self-monitored urine salt excretion using a self-measuring device for 4 weeks. In the control group, urine salt excretion was measured, but the individuals were not informed of the result. Seventy-eight individuals (control group, n 36; intervention group, n 42) collected two 24 h urine samples from a target population of 123 local resident volunteers. The samples were then analysed. There were no differences in clinical background or related parameters between the two groups. The 24 h urinary Na:K ratio showed a significant decrease in the intervention group (-1·1) compared with the control group (-0·0; P=0·033). Blood pressure did not change in either group. The results of the salt check sheet did not change in the control group but were significantly lower in the intervention group. The score of the eating behaviour questionnaire did not change in the control group, but the intervention group showed a significant increase in eating behaviour stage. Self-monitoring of urinary salt excretion helps to improve 24 h urinary Na:K, salt check sheet scores and stage of eating behaviour. Thus, usage of self-monitoring tools has an educational potential in salt intake reduction.
Gorrell, Lindsay M; Engel, Roger M; Lystad, Reidar P; Brown, Benjamin T
Reporting of adverse events in randomized clinical trials (RCTs) is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT) statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT). During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract. A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1) they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2) they mentioned adverse events (or any related terms) in the title or abstract. Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078). Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database. While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of allocation of adverse event indexing terms in both databases. We
Liu, Wei; Ding, Jinhui
The application of the principle of the intention-to-treat (ITT) to the analysis of clinical trials is challenged in the presence of missing outcome data. The consequences of stopping an assigned treatment in a withdrawn subject are unknown. It is difficult to make a single assumption about missing mechanisms for all clinical trials because there are complicated reactions in the human body to drugs due to the presence of complex biological networks, leading to data missing randomly or non-randomly. Currently there is no statistical method that can tell whether a difference between two treatments in the ITT population of a randomized clinical trial with missing data is significant at a pre-specified level. Making no assumptions about the missing mechanisms, we propose a generalized complete-case (GCC) analysis based on the data of completers. An evaluation of the impact of missing data on the ITT analysis reveals that a statistically significant GCC result implies a significant treatment effect in the ITT population at a pre-specified significance level unless, relative to the comparator, the test drug is poisonous to the non-completers as documented in their medical records. Applications of the GCC analysis are illustrated using literature data, and its properties and limits are discussed.
Jensen, Berit E.S.; Hansen, Jane M.; Larsen, Kasper S.
percutaneous coronary intervention and randomized to either screening or control. Screened high-risk patients were prescribed pantoprazole 40 mg during the 1-year after percutaneous coronary intervention. Results The incidence of UGIB was 0.8 versus 1.3% in screened patients and controls, respectively (P=0...
Winchester, Danyelle A; Till, Cathee; Goodman, Phyllis J; Tangen, Catherine M; Santella, Regina M; Johnson-Pais, Teresa L; Leach, Robin J; Xu, Jianfeng; Zheng, S Lilly; Thompson, Ian M; Lucia, M Scott; Lippman, Scott M; Parnes, Howard L; Isaacs, William B; De Marzo, Angelo M; Drake, Charles G; Platz, Elizabeth A
We reported that some, but not all single nucleotide polymorphisms (SNPs) in select immune response genes are associated with prostate cancer, but not individually with the prevalence of intraprostatic inflammation in the Prostate Cancer Prevention Trial (PCPT) placebo arm. Here, we investigated whether these same SNPs are associated with risk of lower- and higher-grade prostate cancer in men randomized to finasteride, and with prevalence of intraprostatic inflammation among controls. Methods A total of 16 candidate SNPs in IL1β, IL2, IL4, IL6, IL8, IL10, IL12(p40), IFNG, MSR1, RNASEL, TLR4, and TNFA and 7 tagSNPs in IL10 were genotyped in 625 white prostate cancer cases, and 532 white controls negative for cancer on an end-of-study biopsy nested in the PCPT finasteride arm. We used logistic regression to estimate log-additive odds ratios (OR) and 95% confidence intervals (CI) adjusting for age and family history. Minor alleles of rs2243250 (T) in IL4 (OR = 1.46, 95% CI 1.03-2.08, P-trend = 0.03), rs1800896 (G) in IL10 (OR = 0.77, 95% CI 0.61-0.96, P-trend = 0.02), rs2430561 (A) in IFNG (OR = 1.33, 95% CI 1.02-1.74; P-trend = 0.04), rs3747531 (C) in MSR1 (OR = 0.55, 95% CI 0.32-0.95; P-trend = 0.03), and possibly rs4073 (A) in IL8 (OR = 0.81, 95% CI 0.64-1.01, P-trend = 0.06) were associated with higher- (Gleason 7-10; N = 222), but not lower- (Gleason 2-6; N = 380) grade prostate cancer. In men with low PSA (prostate cancer, distributions of IL10 haplotypes did not differ, except possibly between higher-grade cases and controls among those with low PSA (P = 0.07). We did not observe an association between the studied SNPs and intraprostatic inflammation in the controls. In the PCPT finasteride arm, variation in genes involved in the immune response, including possibly IL8 and IL10 as in the placebo arm, may be associated with prostate cancer, especially higher-grade disease, but not with intraprostatic
Invitation Cards during Pregnancy Enhance Male Partner Involvement in Prevention of Mother to Child Transmission (PMTCT) of Human Immunodeficiency Virus (HIV) in Blantyre, Malawi: A Randomized Controlled Open Label Trial
Nyondo, Alinane Linda; Choko, Augustine Talumba; Chimwaza, Angela Faith; Muula, Adamson Sinjani
Introduction Male involvement (MI) is vital for the uptake of Prevention of Mother to Child Transmission (PMTCT) of Human Immunodeficiency Virus (HIV) interventions. Partner notification (PN) is among the strategies identified for MI in PMTCT services. The purpose of this randomized controlled trial was to evaluate the efficacy of an invitation card to the male partners as a strategy for MI in PMTCT services by comparing the proportion of pregnant women that were accompanied by their partners...
Full Text Available Abstract Background Gender-specific smoking cessation strategies have rarely been developed. Evidence of effectiveness of physical activity (PA promotion and intervention in adjunct to smoking cessation programs is not strong. SPRINT study is a randomized controlled trial (RCT designed to evaluate a counselling intervention on smoking cessation and PA delivered to women attending the Italian National Health System Cervical Cancer Screening Program. This paper presents study design and baseline characteristics of the study population. Methods/Design Among women undergoing the Pap examination in three study centres (Florence, Turin, Mantua, participants were randomized to the smoking cessation counselling [S], the smoking cessation + PA counselling [S + PA], or the control [C] groups. The program under evaluation is a standard brief counselling on smoking cessation combined with a brief counselling on increasing PA, and was delivered in 2010. A questionnaire, administered before, after 6 months and 1 year from the intervention, was used to track behavioural changes in tobacco use and PA, and to record cessation rates in participants. Discussion Out of the 5,657 women undergoing the Pap examination, 1,100 participants (55% of smokers were randomized in 1 of the 3 study groups (363 in the S, 366 in the S + PA and 371 in the C groups. The three arms did not differ on any demographic, PA, or tobacco-use characteristics. Recruited smokers were older, less educated than non-participant women, more motivated to quit (33% vs.9% in the Preparation stage, p p p Trial registration number ISRCTN: ISRCTN52660565
Ter Veer, Emil; van Kleef, Jessy Joy; Sprangers, Mirjam A G; Haj Mohammad, Nadia; van Oijen, Martijn G H; van Laarhoven, Hanneke W M
Health-related quality of life (HRQoL) assessments are increasingly incorporated into oncological randomized controlled trials (RCTs). The quality of HRQoL reporting in RCTs concerning palliative systemic treatment for advanced esophagogastric cancer is currently unknown. Therefore, we conducted a systematic review to investigate the quality of HRQoL reporting over time. PubMed, CENTRAL and EMBASE were searched for RCTs concerning systemic treatment for advanced esophagogastric cancer up to February 2017. The Minimum Standard Checklist for Evaluating HRQoL Outcomes in Cancer Clinical Trials was used to rate the quality of HRQoL reporting. Univariate and multivariate generalized linear regression analysis was used to investigate factors affecting the quality of reporting over time. In total, 37 original RCTs (N = 10,887 patients) were included. The quality of reporting was classified as 'very limited' in 4 studies (11%), 'limited' in 24 studies (65%), and 'probably robust' in 9 studies (24%). HRQoL reporting did not improve over time, and it did not improve following the publication of the CONSORT-PRO statement in 2013. The publication of HRQoL findings in a separate article and second-line treatment were associated with better reporting. HRQoL reporting in RCTs concerning palliative systemic therapy for advanced esophagogastric cancer is limited and has not improved over time. This systematic review provides specific recommendations for authors to improve HRQoL reporting: formulate hypotheses a priori, clearly describe instrument administration, and handle missing data and interpret findings appropriately.
Lathyris, D N; Patsopoulos, N A; Salanti, G; Ioannidis, J P A
Most clinical trials on medical interventions are sponsored by the industry. The choice of comparators shapes the accumulated evidence. We aimed to assess how often major companies sponsor trials that involve only their own products. Studies were identified by searching ClinicalTrials.gov for trials registered in 2006. We focused on randomized trials involving the 15 companies that had sponsored the largest number of registered trials in ClinicalTrials.gov in that period. Overall, 577 randomized trials were eligible for analysis and 82% had a single industry sponsor [89% (166/187) of the placebo-control trials, 87% (91/105) of trials comparing different doses or ways of administration of the same intervention, and 78% (221/285) of other active control trials]. The compared intervention(s) belonged to a single company in 67% of the trials (89%, 81% and 47% in the three categories respectively). All 15 companies strongly preferred to run trials where they were the only industry sponsor or even the only owner of the assessed interventions. Co-sponsorship typically reflected co-ownership of the same intervention by both companies. Head-to-head comparison of different active interventions developed by different companies occurred in only 18 trials with two or more industry sponsors. Each company generates a clinical research agenda that is strongly focused on its own products, while comparisons involving different interventions from different companies are uncommon. This diminishes the ability to understand the relative merits of different interventions for the same condition.
Full Text Available John M Mayer,1 James L Nuzzo,1 Simon Dagenais2 1School of Physical Therapy and Rehabilitation Sciences, College of Medicine, University of South Florida, Tampa, FL, 2Palladian Health, West Seneca, NY, USA Background: Firefighters are at increased risk for back injuries, which may be mitigated through exercise therapy to increase trunk muscle endurance. However, long-term adherence to exercise therapy is generally poor, limiting its potential benefits. Focus groups can be used to identify key barriers and facilitators to exercise adherence among study participants. Objective: To explore barriers and facilitators to worksite exercise therapy adherence among firefighters to inform future randomized controlled trials (RCTs. Methods: Participants enrolled in a previous RCT requiring twice-weekly worksite exercise therapy for 24 weeks were asked to take part in moderated focus group discussions centered on eight open-ended questions related to exercise adherence. Responses were analyzed qualitatively using a social ecological framework to identify key intrapersonal, interpersonal, and institutional barriers and potential facilitators to exercise adherence. Results: A total of 27 participants were included in the four focus group discussions, representing 50% of those assigned to a worksite exercise therapy group in the previous RCT, in which only 67% of scheduled exercise therapy sessions were completed. Lack of self-motivation was cited as the key intrapersonal barrier to adherence, while lack of peer support was the key interpersonal barrier reported, and lack of time to exercise during work shifts was the key institutional barrier identified. Conclusion: Focus group discussions identified both key barriers and potential facilitators to increase worksite exercise therapy adherence among firefighters. Future studies should consider educating and reminding participants about the benefits of exercise, providing individual and group incentives based on
Effects of intravenous diclofenac on postoperative sore throat in patients undergoing laparoscopic surgery at Aga Khan University Hospital, Nairobi: A prospective, randomized, double blind controlled trial.
Gustafsson, Finn; Atar, Dan; Pitt, Bertram
Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...
Hedden, Sarra L; Woolson, Robert F; Malcolm, Robert J
A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA)-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn randomization schemes and other highly adaptive designs. In many
Hussain-Gambles, M; Leese, B; Atkin, K; Brown, J; Mason, S; Tovey, P
To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. A review of the literature on minority ethnic participation in clinical trials was followed by three qualitative interview studies. Interviews were taped and transcribed (and translated if required) and subjected to framework analysis. Face-to-face interviews were conducted with 25 health professionals; 60 South Asian lay people who had not taken part in a trial and 15 South Asian trial participants. Motivations for trial participation were identified as follows: to help society, to improve own health or that of family and friends, out of obligation to the doctor and to increase scientific knowledge. Deterrents were concerns about drug side-effects, busy lifestyles, language, previous bad experiences, mistrust and feelings of not belonging to British society. There was no evidence of antipathy amongst South Asians to the concept of clinical trials and, overall, the younger respondents were more knowledgeable than the older ones. Problems are more likely to be associated with service delivery. Lack of being approached was a common response. Lay-reported factors that might affect South Asian participation in clinical trials include age, language, social class, feeling of not belonging/mistrust, culture and religion. Awareness of clinical trials varied between each group. There are more similarities than differences in attitudes towards clinical trial participation between the South Asian and the general population
Invitation cards during pregnancy enhance male partner involvement in prevention of mother to child transmission (PMTCT) of human immunodeficiency virus (HIV) in Blantyre, Malawi: a randomized controlled open label trial.
Nyondo, Alinane Linda; Choko, Augustine Talumba; Chimwaza, Angela Faith; Muula, Adamson Sinjani
Male involvement (MI) is vital for the uptake of Prevention of Mother to Child Transmission (PMTCT) of Human Immunodeficiency Virus (HIV) interventions. Partner notification (PN) is among the strategies identified for MI in PMTCT services. The purpose of this randomized controlled trial was to evaluate the efficacy of an invitation card to the male partners as a strategy for MI in PMTCT services by comparing the proportion of pregnant women that were accompanied by their partners between the intervention and the non-intervention study groups. Pregnant women attending antenatal care without a male partner at South Lunzu and Mpemba health centres in Blantyre, Malawi, were enrolled in the study from June to December 2013. In an intention-to-treat analysis, we compared all participants that were randomized in the invitation card group with the standard of care (SoC) group. Risk ratios (RR) with 95% confidence intervals (CI) were computed to assess the efficacy of the invitation card. Of the 462 randomized women, 65/230 (28.26%) of the women in the invitation card group reported to the antenatal care clinic with their partners compared to 44/232 (18.97%) women in the SoC group. In an unadjusted intention-to-treat analysis women in the invitation card group were 50% more likely to be accompanied by their male partners than those in the SoC group RR: 1.49 (95% CI: 1.06-2.09); p = 0.02. Our random effects analysis showed that there was no clustering by site of recruitment with an inter cluster correlation coefficient (ICC) of 1.98 x 10(-3), (95% CI: 1.78 x10(-7) - 0.96 x 10(-1)); p =0.403. An invitation card significantly increased the proportion of women who were accompanied by their male partners for the PMTCT services. An invitation card is a feasible strategy for MI in PMTCT.
Maddali-Bongi, S; Landi, G; Galluccio, F; Del Rosso, A; Miniati, I; Conforti, M L; Casale, R; Matucci-Cerinic, M
In Systemic Sclerosis (SSc), face involvement causes functional loss as well as aesthetic changes and loss of the self-image. The aim of the work is to evaluate the efficacy of a rehabilitation program based on the combination of Kabat's technique, connective massage and kinesitherapy specifically conceived for the face of SSc patients. Forty SSc patients were enrolled: 20 patients (interventional group) were treated for 9 weeks (twice a week, 1 h per session) with a combined connective tissue massage, Kabat's technique, kinesitherapy and home exercise program, and 20 patients (control group) were assigned only home exercise program. All patients were assessed at baseline (T0), at the end of the treatment (T1) and after 9 weeks of follow-up (T2). They were evaluated with SF-36, HAQ, modified Rodnan skin score, mouth opening in centimeters and Mouth Handicap in Systemic Sclerosis (MHISS) scale. At T1, both groups improved in mouth opening (P massage, Kabat's technique, kinesitherapy and home-based exercises is more effective than a home exercise program alone in the rehabilitative treatment of SSc facial involvement.
Controlled Education of patients after Stroke (CEOPS)- nurse-led multimodal and long-term interventional program involving a patient's caregiver to optimize secondary prevention of stroke: study protocol for a randomized controlled trial.
Mendyk, Anne-Marie; Duhamel, Alain; Bejot, Yannick; Leys, Didier; Derex, Laurent; Dereeper, Olivier; Detante, Olivier; Garcia, Pierre-Yves; Godefroy, Olivier; Montoro, Francisco Macian; Neau, Jean-Philippe; Richard, Sébastien; Rosolacci, Thierry; Sibon, Igor; Sablot, Denis; Timsit, Serge; Zuber, Mathieu; Cordonnier, Charlotte; Bordet, Régis
Setting up a follow-up secondary prevention program after stroke is difficult due to motor and cognitive impairment, but necessary to prevent recurrence and improve patients' quality of life. To involve a referent nurse and a caregiver from the patient's social circle in nurse-led multimodal and long-term management of risk factors after stroke could be an advantage due to their easier access to the patient and family. The aim of this study is to compare the benefit of optimized follow up by nursing personnel from the vascular neurology department including therapeutic follow up, and an interventional program directed to the patient and a caregiving member of their social circle, as compared with typical follow up in order to develop a specific follow-up program of secondary prevention of stroke. The design is a randomized, controlled, clinical trial conducted in the French Stroke Unit of the Strokavenir network. In total, 410 patients will be recruited and randomized in optimized follow up or usual follow up for 2 years. In both group, patients will be seen by a neurologist at 6, 12 and 24 months. The optimized follow up will include follow up by a nurse from the vascular neurology department, including therapeutic follow up, and a training program on secondary prevention directed to the patient and a caregiving member of their social circle. After discharge, a monthly telephone interview, in the first year and every 3 months in the second year, will be performed by the nurse. At 6, 12 and 24 month, the nurse will give the patient and caregiver another training session. Usual follow up is only done by the patient's general practitioner, after classical information on secondary prevention of risk factors during hospitalization. The primary outcome measure is blood pressure measured after the first year of follow up. Blood pressure will be measured by nursing personnel who do not know the group into which the patient has been randomized. Secondary endpoints are
Gustafsson, Finn; Atar, Dan; Pitt, Bertram
, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...... discussed by a group of trialists. This review focuses on the arguments for conducting posttrial database studies and presents examples of studies in which posttrial knowledge generation has been substantial. Possible strategies to ensure successful trial database or biobank generation are discussed...
Woolson Robert F
Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn
Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe
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
Baldi, Ileana; Soriani, Nicola; Lorenzoni, Giulia; Azzolina, Danila; Dal Lago, Elisa; De Bardi, Sara; Verduci, Elvira; Zanotti, Renzo; Gregori, Dario
The aim of this study was to assess the quality of reporting of nurse-driven randomized controlled trials involving a direct nutritional intervention. A bibliometric search for randomized controlled trials involving a direct nutritional intervention from 1991 to 2011 in nursing research was conducted. Both quality of the study and design aspects were evaluated. The prevalent randomized controlled trial design used is 2-arm parallel, individual, and randomized with a continuous primary endpoint. Global numbers of randomized controlled trials and the proportion of good-quality randomized controlled trials began a steady and marked rise, more than doubling, from the 1990s to about 2001 and increased slowly thereafter. Studies are overall sufficiently well designed, although there is still room for quality improvement. Additionally, implementation of new randomized controlled trial designs exists and should be advocated.
Invitation cards during pregnancy enhance male partner involvement in prevention of mother to child transmission (PMTCT of human immunodeficiency virus (HIV in Blantyre, Malawi: a randomized controlled open label trial.
Alinane Linda Nyondo
Full Text Available Male involvement (MI is vital for the uptake of Prevention of Mother to Child Transmission (PMTCT of Human Immunodeficiency Virus (HIV interventions. Partner notification (PN is among the strategies identified for MI in PMTCT services. The purpose of this randomized controlled trial was to evaluate the efficacy of an invitation card to the male partners as a strategy for MI in PMTCT services by comparing the proportion of pregnant women that were accompanied by their partners between the intervention and the non-intervention study groups.Pregnant women attending antenatal care without a male partner at South Lunzu and Mpemba health centres in Blantyre, Malawi, were enrolled in the study from June to December 2013. In an intention-to-treat analysis, we compared all participants that were randomized in the invitation card group with the standard of care (SoC group. Risk ratios (RR with 95% confidence intervals (CI were computed to assess the efficacy of the invitation card.Of the 462 randomized women, 65/230 (28.26% of the women in the invitation card group reported to the antenatal care clinic with their partners compared to 44/232 (18.97% women in the SoC group. In an unadjusted intention-to-treat analysis women in the invitation card group were 50% more likely to be accompanied by their male partners than those in the SoC group RR: 1.49 (95% CI: 1.06-2.09; p = 0.02. Our random effects analysis showed that there was no clustering by site of recruitment with an inter cluster correlation coefficient (ICC of 1.98 x 10(-3, (95% CI: 1.78 x10(-7 - 0.96 x 10(-1; p =0.403.An invitation card significantly increased the proportion of women who were accompanied by their male partners for the PMTCT services. An invitation card is a feasible strategy for MI in PMTCT.
Moustgaard, Helene; Bello, Segun; Miller, Franklin G
OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...
Mayo-Wilson, Evan; Grant, Sean; Montgomery, Paul
Randomized controlled trials (RCTs) are increasingly used to evaluate programs and interventions in order to inform education policy and practice. High quality reports of these RCTs are needed for interested readers to understand the rigor of the study, the interventions tested, and the context in which the evaluation took place (Mayo-Wilson et…
Mc Cord, Kimberly A; Al-Shahi Salman, Rustam; Treweek, Shaun; Gardner, Heidi; Strech, Daniel; Whiteley, William; Ioannidis, John P A; Hemkens, Lars G
Routinely collected health data (RCD) are increasingly used for randomized controlled trials (RCTs). This can provide three major benefits: increasing value through better feasibility (reducing costs, time, and resources), expanding the research agenda (performing trials for research questions otherwise not amenable to trials), and offering novel design and data collection options (e.g., point-of-care trials and other designs directly embedded in routine care). However, numerous hurdles and barriers must be considered pertaining to regulatory, ethical, and data aspects, as well as the costs of setting up the RCD infrastructure. Methodological considerations may be different from those in traditional RCTs: RCD are often collected by individuals not involved in the study and who are therefore blinded to the allocation of trial participants. Another consideration is that RCD trials may lead to greater misclassification biases or dilution effects, although these may be offset by randomization and larger sample sizes. Finally, valuable insights into external validity may be provided when using RCD because it allows pragmatic trials to be performed. We provide an overview of the promises, challenges, and potential barriers, methodological implications, and research needs regarding RCD for RCTs. RCD have substantial potential for improving the conduct and reducing the costs of RCTs, but a multidisciplinary approach is essential to address emerging practical barriers and methodological implications. Future research should be directed toward such issues and specifically focus on data quality validation, alternative research designs and how they affect outcome assessment, and aspects of reporting and transparency.
Perkovic, Vlado; Patil, Vinodvenkatesh; Wei, Liu; Lv, Jicheng; Petersen, Marisa; Patel, Anushka
Although modern clinical trials are traditionally conducted in Western countries, currently there is a shift to involve developing countries, particularly China and India. For these trials, the large population size of India and China means that substantial numbers of individuals affected by rare diseases may be found, increasing the likelihood of successfully completing enrollment in a clinical trial. Furthermore, the increasing involvement of Asian countries in global clinical trials is likely to lead to greater appreciation of the value of evidence-based treatment decisions in the region. These sites are more cost-effective, although this advantage is being eroded over time. Asian participants in clinical trials are also typically more likely to complete study follow-up and procedures, and to adhere to their randomized treatment allocation than individuals from Western countries. Challenges include relevance of the proposed trial to the region, capacity limitations because of undeveloped training, and ensuring research implementation quality and different intellectual property practices. There are specific challenges to conducting clinical trials in India, such as the status of ethics committees, health insurance and coverage for participants, and variability in languages and record-keeping. Challenges in both countries are substantial but are able to be managed with appropriate planning.
Chong, Lauren S. H.; Sautenet, Benedicte; Tong, Allison; Hanson, Camilla S.; Samuel, Susan; Zappitelli, Michael; Dart, Allison; Furth, Susan; Eddy, Allison A.; Groothoff, Jaap; Webb, Nicholas J. A.; Yap, Hui-Kim; Bockenhauer, Detlef; Sinha, Aditi; Alexander, Stephen I.; Goldstein, Stuart L.; Gipson, Debbie S.; Raman, Gayathri; Craig, Jonathan C.
To determine the range and heterogeneity of outcomes reported in randomized controlled trials of interventions for children with chronic kidney disease (CKD). The Cochrane Kidney and Transplant Specialized Register was searched to March 2016. Randomized trials involving children across all stages of
Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial).
Fagundes, Felipe Ribeiro Cabral; de Melo do Espírito Santo, Caique; de Luna Teixeira, Francine Mendonça; Tonini, Thaís Vanelli; Cabral, Cristina Maria Nunes
The stratified model of care has been an effective approach for the treatment of low back pain. However, the treatment of patients with low risk of psychosocial-factor involvement is unclear. The addition of the therapeutic alliance to a minimal intervention may be an option for the treatment of low back pain. This paper reports on the rationale, design and protocol for a randomized controlled trial with blind assessor to assess the effectiveness of the addition of therapeutic alliance with minimal intervention on pain and disability in patients with chronic, nonspecific low back pain. Two hundred and twenty-two patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors will be assessed and randomly allocated into three groups (n = 74 patients per group). The Positive Therapeutic Alliance group will receive counseling and guidance with an emphasis on therapeutic alliance and empathy. The Usual Treatment group will receive the same information and counseling with limited interaction with the therapist. The Control group will not receive any intervention. The treatment will be composed by two intervention sessions with a 1-week interval. A blinded assessor will collect the following outcomes at baseline, 1 month, 6 months and 12 months after randomization: pain intensity (Pain Numerical Rating Scale), specific disability (Patient-specific Functional Scale), general disability (Oswestry Disability Index), global perceived effect (Global Perceived Effect Scale), empathy (Consultation and Relational Empathy Measure), credibility and expectations related to treatment. The analysis will be performed using linear mixed models. This will be the first study to understand the effect of combining enhanced therapeutic alliance to a treatment based on counseling, information and advice (minimal intervention). The addition of the therapeutic alliance to minimal intervention may improve the treatment of chronic, nonspecific low back
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
Petersen, Ronald C; Thomas, Ronald G; Aisen, Paul S; Mohs, Richard C; Carrillo, Maria C; Albert, Marilyn S
To examine the variability in performance among placebo groups in randomized controlled trials for mild cognitive impairment (MCI). Placebo group data were obtained from 2 National Institute on Aging (NIA) MCI randomized controlled trials, the Alzheimer's Disease Cooperative Study (ADCS) MCI trial and the Alzheimer's Disease Neuroimaging Initiative (ADNI), which is a simulated clinical trial, in addition to industry-sponsored clinical trials involving rivastigmine, galantamine, rofecoxib, and donepezil. The data were collated for common measurement instruments. The performance of the placebo participants from these studies was tracked on the Alzheimer's Disease Assessment Scale-cognitive subscale, Mini-Mental State Examination, and Clinical Dementia Rating-sum of boxes, and for progression on these measures to prespecified clinical study endpoints. APOE status, where available, was also analyzed for its effects. The progression to clinical endpoints varied a great deal among the trials. The expected performances were seen for the participants in the 2 NIA trials, ADCS and ADNI, with generally worsening of performance over time; however, the industry-sponsored trials largely showed stable or improved performance in their placebo participants. APOE 4 carrier status influenced results in an expected fashion on the study outcomes, including rates of progression and cognitive subscales. In spite of apparently similar criteria for MCI being adopted by the 7 studies, the implementation of the criteria varied a great deal. Several explanations including instruments used to characterize participants and variability among study populations contributed to the findings. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John
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.
Nieder, Carsten; Langendijk, Johannes A.; Guckenberger, Matthias; Grosu, Anca L.
Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [de
Vale, Claire L; Cragg, William J; Cromarty, Ben; Hanley, Bec; South, Annabelle; Stephens, Richard; Sturgeon, Kate; Gafos, Mitzy
Patient and public involvement (PPI) in clinical trials aims to ensure that research is carried out collaboratively with patients and/or members of the public. However, current guidance on involving clinical trial participants in PPI activities is not consistent. We reviewed the concept of participant involvement, based on our experience. Two workshops were held at the MRCCTU at UCL with the aim of defining participant involvement, considering its rationale; benefits and challenges; and identifying appropriate models for participant involvement in clinical trials. We considered how participant involvement might complement the involvement of other public contributors. Both workshops were attended by two patient representatives and seven staff members with experience of PPI in trials. Two of the staff members had also been involved in studies that had actively involved participants. They shared details of that work to inform discussions. We defined trial participants as individuals taking part in the study in question, including those who had already completed their trial treatment and/or follow-up. Because of their direct experience, involving participants may offer advantages over other public contributors; for example, in studies of new interventions or procedures, and where it is hard to identify or reach patient or community groups that include or speak for the study population. Participant involvement is possible at all stages of a trial; however, because there are no participants to involve during the design stage of a trial, prior to enrolment, participant involvement should complement and not replace involvement of PPI stakeholders. A range of models, including those with managerial, oversight or responsive roles are appropriate for involving participants; however, involvement in data safety and monitoring committees may not be appropriate where there is a potential risk of unblinding. Involvement of participants can improve the trial experience for other
Rozenberg, P; Deruelle, P; Sénat, M-V; Desbrière, R; Winer, N; Simon, E; Ville, Y; Kayem, G; Boutron, I
The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be
Bjørndal, Lars; Fransson, Helena; Bruun, Gitte
Deep caries presents a dilemma in terms of which treatment that will render an optimal prognosis by maintaining pulp vitality with absence of apical pathology. Previously, 2 randomized clinical trials were performed testing the short-term effects of stepwise carious tissue removal versus nonselec......Deep caries presents a dilemma in terms of which treatment that will render an optimal prognosis by maintaining pulp vitality with absence of apical pathology. Previously, 2 randomized clinical trials were performed testing the short-term effects of stepwise carious tissue removal versus...... nonselective carious removal to hard dentin with or without pulp exposure. The aim of this article was to report the 5-y outcome on these previously treated patients having radiographically well-defined carious lesions extending into the pulpal quarter of the dentin but with a well-defined radiodense zone...... between the carious lesion and the pulp. In this long-term study, 239 of 314 (76.2%) patients were analyzed. The stepwise removal group had a significantly higher proportion of success (60.2%) at 5-y follow-up compared with the nonselective carious removal to hard dentin group (46.3%) (P = 0.031) when...
Wolfe, Gil I; Kaminski, Henry J; Aban, Inmaculada B; Minisman, Greg; Kuo, Hui-Chien; Marx, Alexander; Ströbel, Philipp; Mazia, Claudio; Oger, Joel; Cea, J Gabriel; Heckmann, Jeannine M; Evoli, Amelia; Nix, Wilfred; Ciafaloni, Emma; Antonini, Giovanni; Witoonpanich, Rawiphan; King, John O; Beydoun, Said R; Chalk, Colin H; Barboi, Alexandru C; Amato, Anthony A; Shaibani, Aziz I; Katirji, Bashar; Lecky, Bryan R F; Buckley, Camilla; Vincent, Angela; Dias-Tosta, Elza; Yoshikawa, Hiroaki; Waddington-Cruz, Márcia; Pulley, Michael T; Rivner, Michael H; Kostera-Pruszczyk, Anna; Pascuzzi, Robert M; Jackson, Carlayne E; Garcia Ramos, Guillermo S; Verschuuren, Jan J G M; Massey, Janice M; Kissel, John T; Werneck, Lineu C; Benatar, Michael; Barohn, Richard J; Tandan, Rup; Mozaffar, Tahseen; Conwit, Robin; Odenkirchen, Joanne; Sonett, Joshua R; Jaretzki, Alfred; Newsom-Davis, John; Cutter, Gary R
Thymectomy has been a mainstay in the treatment of myasthenia gravis, but there is no conclusive evidence of its benefit. We conducted a multicenter, randomized trial comparing thymectomy plus prednisone with prednisone alone. We compared extended transsternal thymectomy plus alternate-day prednisone with alternate-day prednisone alone. Patients 18 to 65 years of age who had generalized nonthymomatous myasthenia gravis with a disease duration of less than 5 years were included if they had Myasthenia Gravis Foundation of America clinical class II to IV disease (on a scale from I to V, with higher classes indicating more severe disease) and elevated circulating concentrations of acetylcholine-receptor antibody. The primary outcomes were the time-weighted average Quantitative Myasthenia Gravis score (on a scale from 0 to 39, with higher scores indicating more severe disease) over a 3-year period, as assessed by means of blinded rating, and the time-weighted average required dose of prednisone over a 3-year period. A total of 126 patients underwent randomization between 2006 and 2012 at 36 sites. Patients who underwent thymectomy had a lower time-weighted average Quantitative Myasthenia Gravis score over a 3-year period than those who received prednisone alone (6.15 vs. 8.99, Pgravis. (Funded by the National Institute of Neurological Disorders and Stroke and others; MGTX ClinicalTrials.gov number, NCT00294658.).
Deserno, Thomas M; Keszei, András P
Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization
Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J
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...
Lee, Regina Lai-Tong; Leung, Cynthia; Chen, Hong; Louie, Lobo H T; Brown, Michael; Chen, Jyu-Lin; Cheung, Gordon; Lee, Paul H
There is a scarcity of resources and studies that utilize targeted weight management interventions to engage parents via mHealth tools targeting obese children and adolescents with mild intellectual disabilities (MIDs) extended from school to a home setting. To test the feasibility and acceptability of a school-based weight program (SBWMP) involving parents via mHealth tools designed to reduce weight, enhance knowledge and adopt healthy lifestyles, and thereby achieve better psychosocial well-being among children and adolescents with MIDs. Four special schools were randomly assigned as intervention or control schools. Students from the intervention group (n = 63) were compared to those in the control group (n = 52), which comprised those with usual school planned activities and no parental involvement. Demographics were considered as covariates in a general linear model, an ordinal regression model and a binary logistic regression model analyzing the relationships between the SBWMP and the outcome variables at baseline (T0) and six months later (T1). Body weight, body mass index, and triceps and subscapular skinfold thickness were lower in the intervention group compared to the control group, although the differences were not statistically significant. There was a positive and direct impact of the SBWMP on students' health knowledge and psychological impacts in the intervention group. The SBWMP extended to the home involving parents via mHealth tools is a feasible and acceptable program for this group with MIDs and their parents.
Regina Lai-Tong Lee
Full Text Available There is a scarcity of resources and studies that utilize targeted weight management interventions to engage parents via mHealth tools targeting obese children and adolescents with mild intellectual disabilities (MIDs extended from school to a home setting. To test the feasibility and acceptability of a school-based weight program (SBWMP involving parents via mHealth tools designed to reduce weight, enhance knowledge and adopt healthy lifestyles, and thereby achieve better psychosocial well-being among children and adolescents with MIDs. Four special schools were randomly assigned as intervention or control schools. Students from the intervention group (n = 63 were compared to those in the control group (n = 52, which comprised those with usual school planned activities and no parental involvement. Demographics were considered as covariates in a general linear model, an ordinal regression model and a binary logistic regression model analyzing the relationships between the SBWMP and the outcome variables at baseline (T0 and six months later (T1. Body weight, body mass index, and triceps and subscapular skinfold thickness were lower in the intervention group compared to the control group, although the differences were not statistically significant. There was a positive and direct impact of the SBWMP on students’ health knowledge and psychological impacts in the intervention group. The SBWMP extended to the home involving parents via mHealth tools is a feasible and acceptable program for this group with MIDs and their parents.
Jackson, Margaret A; Kellett, Margaret; Worthington, Helen V; Clerehugh, Valerie
Although interdental cleaning is an integral component of home plaque control for periodontally involved patients, limited data exist on the periodontal benefits of commonly used interdental cleaning methods before definitive root surface debridement is undertaken. Therefore, the aim of this study was to compare the effects of a customized interdental brushing technique and a customized flossing technique on clinical periodontal outcomes prior to root surface debridement in chronic periodontitis cases. This was a single-blind, randomized controlled clinical trial. Seventy-seven patients with chronic periodontitis were measured for plaque, relative interdental papillae level, Eastman interdental bleeding index, probing depths, and bleeding on probing at interdental sites and underwent a 10-minute hand scaling to remove easily accessible calculus deposits. Before group allocation, patients were advised on toothbrushing and instructed in two customized methods of interdental cleaning involving dental floss and precurved interdental brushes. Materials were supplied after random allocation. Participants were recalled at 6 and 12 weeks for clinical measurements, reinforcement of instructions, and fresh materials. There were significant reductions from baseline for all indices in both groups (P floss group in every parameter (P floss group (P <0.01). This trial demonstrated that patients were able to improve clinical periodontal outcomes by interdental cleaning, particularly with interdental brushes, even before thorough root surface debridement was undertaken.
Lambers Heerspink, Hiddo Jan
Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious
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. PMID:25477991
Full Text Available Abstract Background Hydrodilatation of the glenohumeral joint is by several authors reported to improve shoulder pain and range of motion for patients with adhesive capsulitis. Procedures described often involve the injection of corticosteroids, to which the reported treatment effects may be attributed. Any important contribution arising from the hydrodilatation procedure itself remains to be demonstrated. Methods In this randomized trial, a hydrodilatation procedure including corticosteroids was compared with the injection of corticosteroids without dilatation. Patients were given three injections with two-week intervals, and all injections were given under fluoroscopic guidance. Outcome measures were the Shoulder Pain and Disability Index (SPADI and measures of active and passive range of motion. Seventy-six patients were included and groups were compared six weeks after treatment. The study was designed as an open trial. Results The groups showed a rather similar degree of improvement from baseline. According to a multiple regression analysis, the effect of dilatation was a mean improvement of 3 points (confidence interval: -5 to 11 on the SPADI 0–100 scale. T-tests did not demonstrate any significant between-group differences in range of motion. Conclusion This study did not identify any important treatment effects resulting from three hydrodilatations that included steroid compared with three steroid injections alone. Trial registration The study is registered in Current Controlled Trials with the registration number ISRCTN90567697.
Tveitå, Einar Kristian; Tariq, Rana; Sesseng, Sølve; Juel, Niels Gunnar; Bautz-Holter, Erik
Background Hydrodilatation of the glenohumeral joint is by several authors reported to improve shoulder pain and range of motion for patients with adhesive capsulitis. Procedures described often involve the injection of corticosteroids, to which the reported treatment effects may be attributed. Any important contribution arising from the hydrodilatation procedure itself remains to be demonstrated. Methods In this randomized trial, a hydrodilatation procedure including corticosteroids was compared with the injection of corticosteroids without dilatation. Patients were given three injections with two-week intervals, and all injections were given under fluoroscopic guidance. Outcome measures were the Shoulder Pain and Disability Index (SPADI) and measures of active and passive range of motion. Seventy-six patients were included and groups were compared six weeks after treatment. The study was designed as an open trial. Results The groups showed a rather similar degree of improvement from baseline. According to a multiple regression analysis, the effect of dilatation was a mean improvement of 3 points (confidence interval: -5 to 11) on the SPADI 0–100 scale. T-tests did not demonstrate any significant between-group differences in range of motion. Conclusion This study did not identify any important treatment effects resulting from three hydrodilatations that included steroid compared with three steroid injections alone. Trial registration The study is registered in Current Controlled Trials with the registration number ISRCTN90567697. PMID:18423042
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.
Full Text Available 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.
Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.
BACKGROUND: The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health
Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.
Background The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health
Nieder, Carsten [Nordland Hospital, Department of Oncology and Palliative Medicine, Bodoe (Norway); University of Tromsoe, Department of Clinical Medicine, Faculty of Health Sciences, Tromsoe (Norway); Langendijk, Johannes A. [University Medical Centre Groningen, Department of Radiation Oncology, Groningen (Netherlands); Guckenberger, Matthias [University Hospital Zuerich, Department of Radiation Oncology, Zuerich (Switzerland); Grosu, Anca L. [University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany)
Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [German] Eine Rebestrahlung kann fuer viele Patienten mit rezidivierenden Malignomen eine nuetzliche Option bieten. Der Zweck dieser Studie bestand darin, alle in der juengeren Vergangenheit publizierten randomisierten Studien zu beurteilen, da deren methodische Staerken und Schwaechen, Ergebnisse und resultierende Implikationen bzw. offene Fragen die Planung kuenftiger Studien wesentlich beeinflussen koennen. Systematische Uebersicht aller zwischen 2000 und 2015 veroeffentlichten Studien (Literatursuche ueber PubMed, Scopus und Web of Science). Ausgewertet wurden 9 Studien, in die vor allem Patienten mit Kopf-Hals-Tumoren eingeschlossen waren. Im Median hatten 69 Patienten teilgenommen. Das
This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clincial trials (RCTs) -- the "community equipoise" strategy (CE). The dilemma is that RCTs appear to violate a physician's duty to choose that therapy which there is most reason to believe is in the patient's best interest, randomizing patients even once evidence begins to favor one treatment. The community equipose strategy involves the suggestion that our judgment that neither treatment is to be preferred (that there obtains a state of "equipoise") is to be assessed according to a community rather than an individual standard. Thus, though a physician may personally believe that there is some reason to prefer one treatment, patients can legitimately be randomized if there remains disagreement in the community of medical professionals. Rationales in favor of this conception include the following: (i) medical knowledge is best understood as residing in the community, (ii) the judgments of others count as evidence, and so should change one's own opinion, (iii) subjects would not be better off outside the trial, and (iv) the point of any trial is the resolution of dispute in the medical community. I critically examine these rationales and argue that they are insufficient. Amongst the problems are tensions between various of these underlying rationales, and important ambiguities in just what the CE criterion is to amount to. Finally, I argue that even if use of CE was justified, it would not justify carrying out RCTs anywhere near long enough to discharge our duty to gain reliable knowledge on which to base safe and effective medical practice. Hence, we need some different justification for carrying out RCTs.
Full Text Available Abstract Background Two out of three neonatal deaths occur in just 10 countries and Pakistan stands third among them. Maternal mortality is also high with most deaths occurring during labor, birth, and first few hours after birth. Enhanced access and utilization of skilled delivery and emergency obstetric care is the demonstrated strategy in reducing maternal and neonatal mortality. This trial aims to compare reduction in neonate mortality and utilization of available safe birthing and Emergency Obstetric and Neonatal Care services among pregnant mothers receiving ‘structured birth planning’, and/or ‘transport facilitation’ compared to routine care. Methods A pragmatic cluster randomized trial, with qualitative and economic studies, will be conducted in Jhang, Chiniot and Khanewal districts of Punjab, Pakistan, from February 2011 to May 2013. At least 29,295 pregnancies will be registered in the three arms, seven clusters per arm; 1 structured birth planning and travel facilitation, 2 structured birth planning, and 3 control arm. Trial will be conducted through the Lady Health Worker program. Main outcomes are difference in neonatal mortality and service utilization; maternal mortality being the secondary outcome. Cluster level analysis will be done according to intention-to-treat. Discussion A nationwide network of about 100,000 lady health workers is already involved in antenatal and postnatal care of pregnant women. They also act as “gatekeepers” for the child birthing services. This gate keeping role mainly includes counseling and referral for skill birth attendance and travel arrangements for emergency obstetric care (if required. The review of current arrangements and practices show that the care delivery process needs enhancement to include adequate information provision as well as informed “decision” making and planned “action” by the pregnant women. The proposed three-year research is to develop, through national
Catley, Delwyn; Goggin, Kathy; Harris, Kari Jo; Richter, Kimber P.; Williams, Karen; Patten, Christi; Resnicow, Ken; Ellerbeck, Edward F.; Bradley-Ewing, Andrea; Lee, Hyoung S.; Moreno, Jose L.; Grobe, James E.
Introduction Despite limitations in evidence, the current Clinical Practice Guideline advocates Motivational Interviewing for smokers not ready to quit. This study evaluated the efficacy of Motivational Interviewing (MI) for inducing cessation-related behaviors among smokers with low motivation to quit. Design Randomized clinical trial. Setting/participants Two-hundred fifty-five daily smokers reporting low desire to quit smoking were recruited from an urban community during 2010–2011 and randomly assigned to Motivational Interviewing, health education, or brief advice using a 2:2:1 allocation. Data were analyzed from 2012 to 2014. Intervention Four sessions of Motivational Interviewing utilized a patient-centered communication style that explored patients’ own reasons for change. Four sessions of health education provided education related to smoking cessation while excluding elements characteristic of Motivational Interviewing. A single session of brief advice consisted of brief, personalized advice to quit. Main outcomes measures Self-reported quit attempts, smoking abstinence (biochemically verified), use of cessation pharmacotherapies, motivation, and confidence to quit were assessed at baseline and 3- and 6-month follow-ups. Results Unexpectedly, no significant differences emerged between groups in the proportion who made a quit attempt by 6-month follow-up (Motivational Interviewing, 52.0%; health education, 60.8%; brief advice, 45.1%; p=0.157). Health education had significantly higher biochemically verified abstinence rates at 6 months (7.8%) than brief advice (0.0%) (8% difference, 95% CI=3%, 13%, p=0.003), with the Motivational Interviewing group falling in between (2.9% abstinent, 3% risk difference, 95% CI=0%, 6%, p=0.079). Both Motivational Interviewing and health education groups showed greater increases in cessation medication use, motivation, and confidence to quit relative to brief advice (all pmotivation relative to Motivational Interviewing
Pedersen, Allan Gorm; Petersen, O B; Wara, P
BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...
Gehring, Karin; Sitskoorn, Margriet M; Gundy, Chad M; Sikkes, Sietske A M; Klein, Martin; Postma, Tjeerd J; van den Bent, Martin J; Beute, Guus N; Enting, Roelien H.; Kappelle, Arnoud C; Boogerd, Willem; Veninga, Theo; Twijnstra, Albert; Boerman, Dolf H; Taphoorn, Martin J B; Aaronson, Neil K
PURPOSE: Patients with gliomas often experience cognitive deficits, including problems with attention and memory. This randomized, controlled trial evaluated the effects of a multifaceted cognitive rehabilitation program (CRP) on cognitive functioning and selected quality-of-life domains in patients
Jenner, JA; Nienhuis, FJ; Wiersma, D; van de Willige, G
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
Field, JK; Klaveren, R; Pedersen, JH
Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects...
May 20, 2004 ... The conflict between the design of efficacy trials that give a reasonably sound answer to a very narrow question address- ing a very limited population and the design of effectiveness trials that evaluate complex questions in a more heterogeneous and “real world” population is one example. The former pro-.
Gustafsson, Finn; Atar, Dan; Pitt, Bertram
, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...
Kreiner, Frederik; Galbo, Henrik
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....
Gonçalves, Giulliano Peixoto; Barbosa, Fabiano Timbó; Barbosa, Luciano Timbó; Duarte, José Lira
A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. Our search found 185 original articles, of which 14 were randomized clinical trials. Only one original article (7.1%) showed good quality. There was no statistical significance between the collected data and the data shown in the hypothesis of this search. It can be concluded that in the sample of assessed articles 7% of the randomized clinical trials in intensive care published in a single intensive care journal in Brazil, present good methodological quality.
Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida
conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...
Randomized controlled trial (RCT) can be said to be one of the simplest but most powerful tool of research. It is the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment. Through the randomization, bias will be avoided ...
Wozny, Nathan; Balser, Cary; Ives, Drew
Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…
Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E
randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes...
Shi, Guang-Xia; Li, Qian-Qian; Yang, Bo-Feng; Liu, Yan; Guan, Li-Ping; Wu, Meng-Meng; Wang, Lin-Peng; Liu, Cun-Zhi
In this trial, patients who agreed to random assignment were allocated to a randomized acupuncture group (R-acupuncture group) or control group. Those who declined randomization were assigned to a nonrandomized acupuncture group (NR-acupuncture group). Patients in the R-acupuncture group and NR-acupuncture group received up to 21 acupuncture sessions during a period of 6 weeks plus routine care, while the control group received routine care alone. Cognitive function, activities of daily livin...
Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros
A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.
Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn
Objectives Randomized clinical trials often involve blinding as a methodological procedure to avoid bias. Unfortunately, blinding procedures may be unsuccessful, but the risk of unblinding is rarely reported in trial publications. Our primary aim was to assess the occurrence of unreported assessm...
Stalpers, Lukas J. A.; da Costa, Hanna C.; Merbis, Merijn A. E.; Fortuin, Andries A.; Muller, Martin J.; van Dam, Frits S. A. M.
Purpose: To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). Methods and Materials: After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT
Rosendaal Frits R
Full Text Available Abstract Randomized trials and observational studies, such as case-control studies, are often seen as opposing approaches. However, in many instances results obtained by different designs may complement each other. For instance, case-control studies on aetiology of disease may help to give the direction of future trials. In this commentary, the author discusses the purpose of randomization and observation, and under which conditions one design may be preferred to another. Randomization is useful to combat 'confounding by indication', and is therefore the design of choice for most therapeutic trials. When this confounding is not an issue, as in studies of genetic risk factors or side-effects, then case-control studies are preferred.
Brønd, Marie; Martins, Cesario L; Byberg, Stine
Background: Two doses of measles vaccine (MV) might reduce the nonmeasles mortality rate more than 1 dose of MV does. The effect of 2 versus 1 dose on morbidity has not been examined. Within a randomized trial of the effect of 2 doses versus 1 dose of MV on mortality in Guinea-Bissau, we investig......Background: Two doses of measles vaccine (MV) might reduce the nonmeasles mortality rate more than 1 dose of MV does. The effect of 2 versus 1 dose on morbidity has not been examined. Within a randomized trial of the effect of 2 doses versus 1 dose of MV on mortality in Guinea-Bissau, we...... measles vaccination policy might reduce hospital admissions more than the current policy of providing the first MV at 9 months of age. Trial registration: ClinicalTrials.gov identifier NCT00168558....
Gray, Richard; Badnapurkar, Ashish; Hassanein, Eman; Thomas, Donna; Barguir, Laileah; Baker, Charley; Jones, Martin; Bressington, Daniel; Brown, Ellie; Topping, Annie
Trial registration helps minimize publication and reporting bias. In leading medical journals, 96% of published trials are registered. The aim of this study was to determine the proportion of randomized controlled trials published in key nursing journals that met criteria for timely registration. We reviewed all RCTs published in three (two general, one mental health) nursing journals between August 2011 and September 2016. We classified the included trials as: 1. Not registered, 2. Registered but not reported in manuscript, 3. Registered retrospectively, 4. Registered prospectively (before the recruitment of the first subject into the trial). 5. Timely registration (as 4 but the trial identification number is reported in abstract). We identified 135 trials published in the three included journals. The majority ( n = 78, 58%) were not registered. Thirty-three (24%) were retrospectively registered. Of the 24 (18%) trials that were prospectively registered, 11 (8%) met the criteria for timely registration. There is an unacceptable difference in rates of trial registration between leading medical and nursing journals. Concerted effort is required by nurse researchers, reviewers and journal editors to ensure that all trials are registered in a timely way.
Roux, Gemma; Sofronoff, Kate; Sanders, Matthew
Stepping Stones Triple P (SSTP) is a parenting program designed for families of a child with a disability. The current study involved a randomized controlled trial of Group Stepping Stones Triple P (GSSTP) for a mixed-disability group. Participants were 52 families of children diagnosed with an Autism Spectrum Disorder, Down syndrome, Cerebral Palsy, or an intellectual disability. The results demonstrated significant improvements in parent-reported child behavior, parenting styles, parental satisfaction, and conflict about parenting. Results among participants were similar despite children's differing impairments. The intervention effect was maintained at 6-month follow-up. The results indicate that GSSTP is a promising intervention for a mixed-disability group. Limitations of the study, along with areas for future research, are also discussed. © FPI, Inc.
Mentink, LF; Mackenzie, MW; Toth, GG; Laseur, M; Lambert, FPG; Veeger, NJGM; Cianchini, G; Pavlovic, MD; Jonkman, MF
Objective: To determine the therapeutic effect of adjuvant dexamethasone pulse therapy when given in addition to conventional treatment of pemphigus vulgaris. Design: A randomized, placebo-controlled trial. Setting: International European, multicenter outpatient and inpatient study. Patients: Of the
Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W
Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or
Su, Chun-Xiang; Wang, Li-Qiong; Grant, Suzanne J; Liu, Jian-Ping
To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.
Mayer, Tom G; Gatchel, Robert J; Keeley, Janice; McGeary, Don; Dersh, Jeffrey; Anagnostis, Christopher
A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies. To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR. Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome. From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly
Cebul, R D
The Firm System at MetroHealth Medical Center was begun almost two decades ago to foster improved continuity of patient care and teaching of medical students and residents in Internal Medicine. For the past 8 years, these parallel teams of providers and patients also have been used to conduct clinical, educational, and health care delivery research. Randomized, controlled trials are made possible by ongoing random assignment of patients and providers to the three teams, or small group practices. Each group practice has equivalent inpatient and outpatient areas supported by nonrotating nursing, paramedical, and clerical staff. The system's current relationships were established after a controlled trial established both decreased costs and increased effectiveness of the "group practice model" as compared to more traditional approaches to patient care by residents in an academic medical center. Other trials, both on the inpatient and outpatient settings, have been used to guide ongoing institutional change. The unique advantages of the randomized controlled trial are high-lighted by contrasting the results of within-group changes during an intervention with results that incorporate control group changes. A variety of methodologic and logistical issues must be addressed when conducting controlled trials that use ongoing randomization within a single institution. These include determination that the groups are equivalent for all important parameters preintervention, choosing an analytic approach that accounts for potential differences among providers and patients, and, in trials designed to affect behavior, assurance that a "steady state" exists prior to initiating another trial designed to affect similar behavior. Consideration also must be given to the possibilities of cross-team contamination, the Hawthorne effect, the "dominant attending effect," and ethical issues related to informed consent. Clinical trials in a single institution may be performed for common
Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S
The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could
Foss, Kim Thestrup; Kjærgaard, Jesper; Stensballe, Lone Graff
for the purpose of informing expectant mothers about The Danish Calmette Study; a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers received an invitation letter with a Participant Information Sheet about The Danish Calmette Study, the present trial, and a Consent...
Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N
Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.
Verberk, W. J.; Kroon, A. A.; Kessels, A. G. H.; Nelemans, P. J.; van Ree, J. W.; Lenders, J. W. M.; Thien, T.; Bakx, J. C.; van Montfrans, G. A.; Smit, A. J.; Beltman, F. W.; de Leeuw, P. W.
Background. Several methods of randomization are available to create comparable intervention groups in a study. In the HOMERUS-trial, we compared the minimization procedure with a stratified and a non-stratified method of randomization in order to test which one is most appropriate for use in
Verberk, W.J.; Kroon, A.A.; Kessels, A.G.H.; Nelemans, P.J.; Ree, J.W. van; Lenders, J.W.M.; Thien, Th.; Bakx, J.C.; Montfrans, G.A. van; Smit, A.J.; Beltman, F.W.; Leeuw, P.W. de
BACKGROUND: Several methods of randomization are available to create comparable intervention groups in a study. In the HOMERUS-trial, we compared the minimization procedure with a stratified and a non-stratified method of randomization in order to test which one is most appropriate for use in
Full Text Available Our study aimed to assess the impact of a six-months nutrition program, taught by trained teachers, on fruit and vegetable consumption among children in grades 1 to 4. Four hundred and sixty-four children (239 female, 6 to 12 years old, from seven elementary schools were assigned to this randomized trial. Teachers were trained by researchers over six months, according to the following topics: nutrition, healthy eating, and strategies to increase physical activity. After each session, teachers were encouraged to develop activities in the classroom on the topics learned. Children's sociodemographic, anthropometric, dietary, and physical activity data were assessed at baseline and at the end of the intervention. The effect sizes ranged between small (Cohen's d=0.12 on “other vegetables” to medium (0.56 on “fruit and vegetable”, and intervened children reported a significantly higher consumption of vegetables and fruit. Interventions involving trained teachers offer promise to increase consumption of fruit and vegetable in children.
Dierick-van Daele, Angelique T M; Metsemakers, Job F M; Derckx, Emmy W C C; Spreeuwenberg, Cor; Vrijhoef, Hubertus J M
This paper is a report of a study conducted to evaluate process and outcomes of care provided to patients with common complaints by general practitioners or specially trained nurse practitioners as first point of contact. Studies in the United States of America and Great Britain show that substituting nurse practitioners for general practitioners results in higher patient satisfaction and higher quality of care. As the American and British healthcare system and settings differ from that in The Netherlands, a Dutch trial was conducted. A total of 1501 patients in 15 general practices were randomized to consultation by a general practitioner or a nurse practitioner. Data were collected over a 6-month period in 2006 by means of questionnaires, extracting medical records from practice computer systems and recording the length of consultations. In both groups, the patients highly appreciated the quality of care. No statistically significant differences were found in health status, medical resource consumption and compliance of practical guidelines in primary care in The Netherlands. Patients in the NP intervention group were more often invited to re-attend, had more follow-up consultations and their consultations took statistically significantly longer. Nurse practitioners and general practitioners provide comparable care. Our findings support an increased involvement of specially trained nurse practitioners in the Dutch primary care and contribute to knowledge of the effectiveness of care provision by nurse practitioners from a national and international perspective.
A double-blind randomized controlled trial of diazepam against placebo in the management of minor conditions seen in general practice demonstrated that administration of either diazepam or placebo was associated with a substantial reduction in symptomatology three weeks later. There was no demonstrable difference between diazepam and placebo.
Sytema, S.; Wunderink, L.; Bloemers, W.; Roorda, L.; Wiersma, D.
Objective: Assertive community treatment is rapidly implemented by many European mental health services, but recently the evidence base has been questioned. Positive results of randomized trials in the USA were not replicated in the UK. The question is whether the UK findings are representative for
The study was a single‑blind randomized controlled clinical trial. Perceived stress scale (PSS) was measured during the 12th, 20th, and 28th weeks of pregnancy. SPSS version 16.0 (Chicago, IL, USA) was used for all data analysis. When the data were found to be normally distributed,the RMANOVA were used to assess ...
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
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…
A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.
Sorenson, James L.; Masson, Carmen L.; Delucchi, Kevin; Sporer, Karl; Barnett, Paul G.; Mitsuishi, Fumi; Lin, Christine; Song, Yong; Chen, TeChieh; Hall, Sharon M.
A clinical trial contrasted 2 interventions designed to link opioid-dependent hospital patients to drug abuse treatment. The 126 out-of-treatment participants were randomly assigned to (a) case management, (b) voucher for free methadone maintenance treatment (MMT), (c) case management plus voucher, or (d) usual care. Services were provided for 6…
Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia
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…
Stalpers, Lukas J.A.; Costa, Hanna C. da; Merbis, Merijn A.E.; Fortuin, Andries A.; Muller, Martin J.; Dam, Frits van
Purpose: To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). Methods and materials: After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT plus hypnotherapy (33 patients). Patients in the hypnotherapy group received hypnotherapy at the intake, before RT simulation, before the first RT session, and halfway between the RT course. Anxiety was evaluated by the State-Trait Anxiety Inventory DY-1 form at six points. Quality of life was measured by the Rand Medical Outcomes Study 36-item Health Survey (SF-36) at five points. Additionally, patients answered a questionnaire to evaluate their experience and the possible benefits of this research project. Results: No statistically significant difference was found in anxiety or quality of life between the hypnotherapy and control groups. However, significantly more patients in the hypnotherapy group indicated an improvement in mental (p < 0.05) and overall (p < 0.05) well-being. Conclusion: Hypnotherapy did not reduce anxiety or improve the quality of life in cancer patients undergoing curative RT. The absence of statistically significant differences between the two groups contrasts with the hypnotherapy patients' own sense of mental and overall well-being, which was significantly greater after hypnotherapy. It cannot be excluded that the extra attention by the hypnotherapist was responsible for this beneficial effect in the hypnotherapy group. An attention-only control group would be necessary to control for this effect
Park, Bongki; Noh, Hyeonseok; Choi, Dong-Jun
Xerostomia (dry mouth) causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food. Many cancer patients have complained of xerostomia induced by cancer therapy. The aim of this systematic review is to assess the efficacy of herbal medicine for the treatment of xerostomia in cancer patients. Randomized controlled trials investigating the use of herbal medicines to treat xerostomia in cancer patients were included. We searched the following 12 databases without restrictions on time or language. The risk of bias was assessed using the Cochrane Risk of Bias Tool. Twenty-five randomized controlled trials involving 1586 patients met the inclusion criteria. A total of 24 formulas were examined in the included trials. Most of the included trials were insufficiently reported in the methodology section. Five formulas were shown to significantly improve the salivary flow rate compared to comparators. Regarding the grade of xerostomia, all formulas with the exception of a Dark Plum gargle solution with normal saline were significantly effective in reducing the severity of dry mouth. Adverse events were reported in 4 trials, and adverse effects of herbal medicine were reported in 3 trials. We found herbal medicines had potential benefits for improving salivary function and reducing the severity of dry mouth in cancer patients. However, methodological limitations and a relatively small sample size reduced the strength of the evidence. More high-quality trials reporting sufficient methodological data are warranted to enforce the strength of evidence regarding the effectiveness of herbal medicines.
Pandis, Nikolaos; Shamseer, Larissa; Kokich, Vincent G; Fleming, Padhraig S; Moher, David
To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously. Copyright © 2014 Elsevier Inc. All rights reserved.
Terevnikov, Viacheslav; Joffe, Grigori; Stenberg, Jan-Henry
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
Liu, Ying; Wang, Yuanjia; Zeng, Donglin
Sequential multiple assignment randomization trial (SMART) is a powerful design to study Dynamic Treatment Regimes (DTRs) and allows causal comparisons of DTRs. To handle practical challenges of SMART, we propose a SMART with Enrichment (SMARTER) design, which performs stage-wise enrichment for SMART. SMARTER can improve design efficiency, shorten the recruitment period, and partially reduce trial duration to make SMART more practical with limited time and resource. Specifically, at each subsequent stage of a SMART, we enrich the study sample with new patients who have received previous stages' treatments in a naturalistic fashion without randomization, and only randomize them among the current stage treatment options. One extreme case of the SMARTER is to synthesize separate independent single-stage randomized trials with patients who have received previous stage treatments. We show data from SMARTER allows for unbiased estimation of DTRs as SMART does under certain assumptions. Furthermore, we show analytically that the efficiency gain of the new design over SMART can be significant especially when the dropout rate is high. Lastly, extensive simulation studies are performed to demonstrate performance of SMARTER design, and sample size estimation in a scenario informed by real data from a SMART study is presented. © 2016, The International Biometric Society.
Full Text Available Abstract The cluster randomized trial (CRT is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.
Probiotics traditionally used in medicine field are now being used in an attempt to control and treat periodontal disease. However, the trials used to analyze the effects of probiotics have been subject to methodological criticism. The aim of this review was to assess the methodological deficiencies in randomized controlled trials evaluating the efficacy and safety of oral administration of probiotics for the treatment of periodontal disease. A manual and electronic literature search (of MEDLINE and The Cochrane Library) was made, to March 2011, for randomized controlled trials presenting clinical, microbiological, immunological and patient-centered data for the efficacy of probiotics compared with a placebo/standard periodontal therapy for the treatment of periodontal disease. The literature search yielded only four randomized double-blind, placebo-controlled studies that evaluated the efficacy of probiotics (using Lactobacillus reuteri and Lactobacillus salivarius probiotic strains) in patients with gingivitis. The studies were too methodologically flawed (of mediocre quality) with a high risk of bias for any meaningful conclusions to be reached. These studies lacked adequate descriptions of appropriate randomization, allocation concealment, blinding, formulation and dosage of probiotic and placebo, extent and severity of periodontal disease in patient populations, patient-centered outcomes, results data and potential confounding factors. The existing randomized controlled trials have important methodological limitations; consequently, there is insufficient evidence to support the efficacy of probiotics in treating periodontal disease. More rigorous scientific research, in accordance with existing guidelines and research recommendations of the present review, is required to examine the safety and efficacy of probiotics before they are embraced in periodontal therapy. © 2011 John Wiley & Sons A/S.
Raymond P. Guiteras
Full Text Available In many randomized trials, subjects enter the sample sequentially. Because the covariates for all units are not known in advance, standard methods of stratification do not apply. We describe and assess the method of DA-optimal sequential allocation (Atkinson, 1982 for balancing stratification covariates across treatment arms. We provide simulation evidence that the method can provide substantial improvements in precision over commonly employed alternatives. We also describe our experience implementing the method in a field trial of a clean water and handwashing intervention in Dhaka, Bangladesh, the first time the method has been used. We provide advice and software for future researchers.
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
Brinkhaus, Benno; Roll, Stephanie; Jena, Susanne; Icke, Katja; Adam, Daniela; Binting, Sylvia; Lotz, Fabian; Willich, Stefan N; Witt, Claudia M
Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone. Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months. A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group. In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.
Gilstad, John R; Finucane, Thomas E
Whether donepezil provides meaningful benefit to patients with Alzheimer's disease (AD) is controversial, but drug sales annually total billions of dollars. A review of data from published randomized clinical trials (RCTs) found rhetorical patterns that may encourage use of this drug. To create a reproducible observation, the sentences occurring at five specific text sites in all 18 RCTs of donepezil for AD were tabulated, as were study design, sources of financial support, and outcomes that could be compared between trials. Rhetoric in the 13 vendor-supported trials (15 publications) was strongly positive. Three early trials used the motif "efficacious (or effective) ... treating ... symptoms" four times. "Well-tolerated and efficacious" or an equivalent motif appeared 11 times in five RCTs. Nine RCTs referred 15 times to previously proven effectiveness. Seven trials encourage off-label use, for "early" cognitive impairment, severe dementia in advance of the Food and Drug Administration labeling change, or behavioral symptoms. These rhetorical motifs and themes appeared only in the vendor-supported trials. Trials without vendor support described the drug's effects as "small" or absent; two emphasized the need for better treatments. RCT results were highly consistent in all trials; the small differences do not explain differences in rhetoric. At these text sites in the primary research literature on donepezil for AD, uniformly positive rhetoric is present in all vendor-supported RCTs. Reference to the limited benefit of donepezil is confined to RCTs without vendor support. Data in the trials are highly consistent. This observation generates the hypothesis that rhetoric in vendor-supported published RCTs may promote vendors' products.
Kruse, A Y; Kjaergard, L L; Krogsgaard, K
and attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple......To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... by 0.5 for the control, 1.0 for the leaflet, 1.6 for the brochure, and 1.4 for the booklet. The brochure and the booklet improved the knowledge score significantly compared with the control. The general attitude was positive at entry (mean 71.5 points). Only the booklet significantly increased...
O'Leary, D Peter
Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.
Karline Treurnicht Naylor
Full Text Available The aim of this study was to systematically review the effectiveness of music on pediatric health-related outcomes. Five electronic databases were searched for randomized controlled/crossover trial designs published between 1984 and 2009. Eligible studies used music as a therapy or intervention, included participants 1 to 18 years, and focused on at least one health-related outcome (with the exclusion of procedural pain. Seventeen studies met the inclusion criteria. Quantitative synthesis was hampered by an inability to aggregate data arising from heterogeneity of interventions, outcomes and measurement tools. Qualitative synthesis revealed significant improvements in one or more health outcomes within four of seven trials involving children with learning and developmental disorders; two of three trials involving children experiencing stressful life events; and four of five trials involving children with acute and/or chronic physical illness. No significant effects were found for two trials involving children with mood disorders and related psychopathology. These findings offer limited qualitative evidence to support the effectiveness of music on health-related outcomes for children and adolescents with clinical diagnoses. Recommendations for establishing a consensus on research priorities and addressing methodological limitations are put forth to support the continued advancement of this popular intervention.
Ibarra-Sifuentes, Héctor Raúl; Del Cueto-Aguilera, Ángel; Gallegos-Arguijo, Daniel Alberto; Castillo-Torres, Sergio Andres; Vera-Pineda, Raymundo; Martínez-Granados, Rolando Jacob; Atilano-Díaz, Alexandro; Cuellar-Monterrubio, Jesus Eduardo; Pezina-Cantú, Cesar Octaviano; Martínez-Guevara, Edgar de Jesús; Ortiz-Treviño, Juan Francisco; Delgado-García, Guillermo Rubén; Martínez-Jiménez, José Guadalupe; Cruz-Valdez, Jesús; Sánchez-Martínez, Concepción
Intradialytic hypotension is common complication in stage 5 chronic kidney disease patients on hemodialysis. Incidence ranges from 15 to 30%. These patients have levocarnitine deficiency. A randomized, placebo-controlled quadruple-blinded trial was designed to demonstrate the levocarnitine efficiency on intradialytic hypotension prevention. Patients were randomized into four groups, to receive levocarnitine or placebo. During the intervention period, levocarnitine and placebo was administered 0 and 30 min before each hemodialysis session, respectively. During the trial, 33 patients received 1188 hemodialysis sessions. We identified 239 (21.3%) intradialytic hypotension episodes. The intradialytic hypotension episodes were less frequent in the levocarnitine group (9.3%, 60 IH events) (P hypotension episodes. Levocarnitine supplementation before each hemodialysis session efficiently diminishes the intradialytic hypotension episodes. This is a new application method that must be considered and explored. © 2017 International Society for Apheresis, Japanese Society for Apheresis, and Japanese Society for Dialysis Therapy.
Wu, Darong; Akl, Elie A; Guyatt, Gordon H; Devereaux, Philip J; Brignardello-Petersen, Romina; Prediger, Barbara; Patel, Krupesh; Patel, Namrata; Lu, Taoying; Zhang, Yuan; Falavigna, Maicon; Santesso, Nancy; Mustafa, Reem A; Zhou, Qi; Briel, Matthias; Schünemann, Holger J
Although even randomization (that is, approximately 1:1 randomization ratio in study arms) provides the greatest statistical power, designed uneven randomization (DUR), (for example, 1:2 or 1:3) is used to increase participation rates. Until now, no convincing data exists addressing the impact of DUR on participation rates in trials. The objective of this study is to evaluate the epidemiology and to explore factors associated with DUR. We will search for reports of RCTs published within two years in 25 general medical journals with the highest impact factor according to the Journal Citation Report (JCR)-2010. Teams of two reviewers will determine eligibility and extract relevant information from eligible RCTs in duplicate and using standardized forms. We will report the prevalence of DUR trials, the reported reasons for using DUR, and perform a linear regression analysis to estimate the association between the randomization ratio and the associated factors, including participation rate, type of informed consent, clinical area, and so on. A clearer understanding of RCTs with DUR and its association with factors in trials, for example, participation rate, can optimize trial design and may have important implications for both researchers and users of the medical literature.
Sullivan, Thomas R; White, Ian R; Salter, Amy B; Ryan, Philip; Lee, Katherine J
The use of multiple imputation has increased markedly in recent years, and journal reviewers may expect to see multiple imputation used to handle missing data. However in randomized trials, where treatment group is always observed and independent of baseline covariates, other approaches may be preferable. Using data simulation we evaluated multiple imputation, performed both overall and separately by randomized group, across a range of commonly encountered scenarios. We considered both missing outcome and missing baseline data, with missing outcome data induced under missing at random mechanisms. Provided the analysis model was correctly specified, multiple imputation produced unbiased treatment effect estimates, but alternative unbiased approaches were often more efficient. When the analysis model overlooked an interaction effect involving randomized group, multiple imputation produced biased estimates of the average treatment effect when applied to missing outcome data, unless imputation was performed separately by randomized group. Based on these results, we conclude that multiple imputation should not be seen as the only acceptable way to handle missing data in randomized trials. In settings where multiple imputation is adopted, we recommend that imputation is carried out separately by randomized group.
Larose, Guylaine; Levy, Arielle; Bailey, Benoit; Cummins-McManus, Barbara; Lebel, Denis; Gravel, Jocelyn
To evaluate whether a clinical aid providing precalculated medication doses decreases prescribing errors among residents during pediatric simulated cardiopulmonary arrest and anaphylaxis. A crossover randomized trial was conducted in a tertiary care hospital simulation center with residents rotating in the pediatric emergency department. The intervention was a reference book providing weight-based precalculated doses. The control group used a card providing milligram-per-kilogram doses. The primary outcome was the presence of a prescribing error, defined as a dose varying by ≥20% from the recommended dose or by incorrect route. Residents were involved in 2 sets of paired scenarios and were their own control group. Primary analysis was the difference in mean prescribing error proportions between both groups. Forty residents prescribed 1507 medications or defibrillations during 160 scenarios. The numbers of prescribing errors per 100 bolus medications or defibrillations were 5.1 (39 out of 762) and 7.5 (56 out of 745) for the intervention and control, respectively, a difference of 2.4 (95% confidence interval [CI], -0.1 to 5.0). However, the intervention was highly associated with lower risk of 10-fold error for bolus medications (odds ratio 0.27; 95% CI, 0.10 to 0.70). For medications administered by infusion, prescribing errors occurred in 3 out of 76 (4%) scenarios in the intervention group and 13 out of 76 (22.4%) in the control group, a difference of 13% (95% CI, 3 to 23). A clinical aid providing precalculated medication doses was not associated with a decrease in overall prescribing error rates but was highly associated with a lower risk of 10-fold error for bolus medications and for medications administered by continuous infusion. Copyright © 2017 by the American Academy of Pediatrics.
Morillo, Carlos A; Marin-Neto, Jose Antonio; Avezum, Alvaro; Sosa-Estani, Sergio; Rassi, Anis; Rosas, Fernando; Villena, Erick; Quiroz, Roberto; Bonilla, Rina; Britto, Constança; Guhl, Felipe; Velazquez, Elsa; Bonilla, Laura; Meeks, Brandi; Rao-Melacini, Purnima; Pogue, Janice; Mattos, Antonio; Lazdins, Janis; Rassi, Anis; Connolly, Stuart J; Yusuf, Salim
The role of trypanocidal therapy in patients with established Chagas' cardiomyopathy is unproven. We conducted a prospective, multicenter, randomized study involving 2854 patients with Chagas' cardiomyopathy who received benznidazole or placebo for up to 80 days and were followed for a mean of 5.4 years. The primary outcome in the time-to-event analysis was the first event of any of the components of the composite outcome of death, resuscitated cardiac arrest, sustained ventricular tachycardia, insertion of a pacemaker or implantable cardioverter-defibrillator, cardiac transplantation, new heart failure, stroke, or other thromboembolic event. The primary outcome occurred in 394 patients (27.5%) in the benznidazole group and in 414 (29.1%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.81 to 1.07; P=0.31). At baseline, a polymerase-chain-reaction (PCR) assay was performed on blood samples obtained from 1896 patients; 60.5% had positive results for Trypanosoma cruzi on PCR. The rates of conversion to negative PCR results (PCR conversion) were 66.2% in the benznidazole group and 33.5% in the placebo group at the end of treatment, 55.4% and 35.3%, respectively, at 2 years, and 46.7% and 33.1%, respectively, at 5 years or more (P<0.001 for all comparisons). The effect of treatment on PCR conversion varied according to geographic region: in Brazil, the odds ratio for PCR conversion was 3.03 (95% CI, 2.12 to 4.34) at 2 years and 1.87 (95% CI, 1.33 to 2.63) at 5 or more years; in Colombia and El Salvador, the odds ratio was 1.33 (95% CI, 0.90 to 1.98) at 2 years and 0.96 (95% CI, 0.63 to 1.45) at 5 or more years; and in Argentina and Bolivia, the odds ratio was 2.63 (95% CI, 1.89 to 3.66) at 2 years and 2.79 (95% CI, 1.99 to 3.92) at 5 or more years (P<0.001 for interaction). However, the rates of PCR conversion did not correspond to effects on clinical outcome (P=0.16 for interaction). Trypanocidal therapy with benznidazole in patients with
Morris, Jill K.; Vidoni, Eric D.; Johnson, David K.; Van Sciver, Angela; Mahnken, Jonathan D.; Honea, Robyn A.; Wilkins, Heather M.; Brooks, William M.; Billinger, Sandra A.; Swerdlow, Russell H.; Burns, Jeffrey M.
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 ...
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
Ramskov, Daniel; Nielsen, Rasmus Oestergaard; Sørensen, Henrik
BACKGROUND: Injury incidence and prevalence in running populations have been investigated and documented in several studies. However, knowledge about injury etiology and prevention is needed. Training errors in running are modifiable risk factors and people engaged in recreational running need...... evidence-based running schedules to minimize the risk of injury. The existing literature on running volume and running intensity and the development of injuries show conflicting results. This may be related to previously applied study designs, methods used to quantify the performed running...... and the statistical analysis of the collected data. The aim of the Run Clever trial is to investigate if a focus on running intensity compared with a focus on running volume in a running schedule influences the overall injury risk differently. METHODS/DESIGN: The Run Clever trial is a randomized trial with a 24-week...
Bendszus, Martin; Hacke, Werner
The purpose is to review the results and impact of recent positive studies on endovascular stroke treatment in the context of previous negative trials. Since October 2014, the results of five randomized controlled multicenter trials on the endovascular stroke treatment as adjunct to conservative treatment (largely including intravenous tissue-type plasminogen activator) versus conservative treatment alone have been published. All of these trials largely used stent retrievers as endovascular device and included patients with proven large vessel occlusion (mostly distal internal carotid or proximal middle cerebral artery (M1), short time windows after stroke onset and mostly small infarctions on initial imaging. Over all there was an overwhelming beneficial effect on outcome measured as shift in the modified Rankin Scale score and independent survival, respectively. Moreover, the rate of adverse events, in particular hemorrhage rate, was not increased. These new findings contrast previous studies on endovascular stroke treatment using mostly first generation nonstent retriever devices, longer time windows and different imaging inclusion criteria, which were overall neutral for patient outcome. Endovascular stroke treatment with stent retrievers is the standard of care in large vessel occlusion. New randomized controlled trials should investigate safety and efficacy in extended indications as advanced time windows or more extensive signs of ischemia on initial imaging. The same applies for new devices apart from stent retrievers.
Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.
Rothwell, Erin; Wong, Bob; Rose, Nancy C.; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A.; Botkin, Jeffrey R.
A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. PMID:25747685
Clark, Laura; Ronaldson, Sarah; Dyson, Lisa; Hewitt, Catherine; Torgerson, David; Adamson, Joy
To assess the effectiveness of sending electronic prompts to randomized controlled trial participants to return study questionnaires. A "trial within a trial" embedded within a study determining the effectiveness of chronic obstructive pulmonary disease (DOC) screening on smoking cessation. Those participants taking part in DOC who provided a mobile phone number and/or an electronic mail address were randomized to either receive an electronic prompt or no electronic prompt to return a study questionnaire. The results were combined with two previous studies in a meta-analysis. A total of 437 participants were randomized: 226 to the electronic prompt group and 211 to the control group. A total of 285 (65.2%) participants returned the follow-up questionnaire: 157 (69.5%) in the electronic prompt group and 128 (60.7%) in the control group [difference 8.8%; 95% confidence interval (CI): -0.11%, 17.7%; P = 0.05]. The mean time to response was 23 days in the electronic prompt group and 33 days in the control group (hazard ratio = 1.27; 95% CI: 1.105, 1.47). The meta-analysis of all three studies showed an increase in response rate of 7.1% (95% CI: 0.8%, 13.3%). The use of electronic prompts increased response rates and reduces the time to response. Copyright © 2015 Elsevier Inc. All rights reserved.
Poh Catherine F
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
Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G
To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.
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.
Freedman Laurence S
Full Text Available Abstract Background Many randomized trials involve missing binary outcomes. Although many previous adjustments for missing binary outcomes have been proposed, none of these makes explicit use of randomization to bound the bias when the data are not missing at random. Methods We propose a novel approach that uses the randomization distribution to compute the anticipated maximum bias when missing at random does not hold due to an unobserved binary covariate (implying that missingness depends on outcome and treatment group. The anticipated maximum bias equals the product of two factors: (a the anticipated maximum bias if there were complete confounding of the unobserved covariate with treatment group among subjects with an observed outcome and (b an upper bound factor that depends only on the fraction missing in each randomization group. If less than 15% of subjects are missing in each group, the upper bound factor is less than .18. Results We illustrated the methodology using data from the Polyp Prevention Trial. We anticipated a maximum bias under complete confounding of .25. With only 7% and 9% missing in each arm, the upper bound factor, after adjusting for age and sex, was .10. The anticipated maximum bias of .25 × .10 =.025 would not have affected the conclusion of no treatment effect. Conclusion This approach is easy to implement and is particularly informative when less than 15% of subjects are missing in each arm.
Elder Charles R
Full Text Available Abstract Background Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance. Methods Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®, or a control intervention comprised of social-support group meetings (SS led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation. Results Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd = 11, mean BMI at randomization was 34 (sd = 5, and mean initial weight loss was 9.8 kg (sd = 5. In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85 weight regain for TAT and 2.96 kg (se 0.96 weight regain for SS, p post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT. Conclusions The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary
Morgan, Philip J; Young, Myles D; Lloyd, Adam B; Wang, Monica L; Eather, Narelle; Miller, Andrew; Murtagh, Elaine M; Barnes, Alyce T; Pagoto, Sherry L
Despite their important influence on child health, it is assumed that fathers are less likely than mothers to participate in pediatric obesity treatment and prevention research. This review investigated the involvement of fathers in obesity treatment and prevention programs targeting children and adolescents (0-18 years). A systematic review of English, peer-reviewed articles across 7 databases. Retrieved records included at least 1 search term from 2 groups: "participants" (eg, child*, parent*) and "outcomes": (eg, obes*, diet*). Randomized controlled trials (RCTs) assessing behavioral interventions to prevent or treat obesity in pediatric samples were eligible. Parents must have "actively participated" in the study. Two authors independently extracted data using a predefined template. The search retrieved 213 eligible RCTs. Of the RCTs that limited participation to 1 parent only (n = 80), fathers represented only 6% of parents. In RCTs in which participation was open to both parents (n = 133), 92% did not report objective data on father involvement. No study characteristics moderated the level of father involvement, with fathers underrepresented across all study types. Only 4 studies (2%) suggested that a lack of fathers was a possible limitation. Two studies (1%) reported explicit attempts to increase father involvement. The review was limited to RCTs published in English peer-reviewed journals over a 10-year period. Existing pediatric obesity treatment or prevention programs with parent involvement have not engaged fathers. Innovative strategies are needed to make participation more accessible and engaging for fathers. Copyright © 2017 by the American Academy of Pediatrics.
Kopple, J.D.; Cheung, A.K.; Christiansen, J.S.
BACKGROUND: The mortality rate of maintenance hemodialysis (MHD) patients remains high. Measures of protein-energy wasting, including hypoalbuminemia, are strongly associated with their high mortality. Growth hormone (GH) may improve lean body mass (LBM) and serum albumin levels, and health......-related quality of life (HRQoL), which are significantly and positively associated with survival in MHD patients. The OPPORTUNITY Trial will examine whether GH reduces mortality and morbidity and improves overall health in hypoalbuminemic MHD patients. HYPOTHESIS: The primary hypothesis is that daily recombinant......, and HRQoL, and has a favorable safety profile. DESIGN/MEASUREMENTS: This is a prospective, double-blind, multicenter, randomized clinical trial involving 2500 MHD patients, up to 50% with diabetes mellitus, from 22 countries. Patients are randomized in a 1:1 ratio to receive daily injections of GH (20...
Tokolahi, Ema; Hocking, Clare; Kersten, Paula; Vandal, Alain C
Growing use of cluster randomized control trials (RCTs) in health care research requires careful attention to study designs, with implications for the development of an evidence base for practice. The objective of this study is to investigate the characteristics, quality, and reporting of cluster RCTs evaluating occupational therapy interventions to inform future research design. An extensive search of cluster RCTs evaluating occupational therapy was conducted in several databases. Fourteen studies met our inclusion criteria; four were protocols. Eleven (79%) justified the use of a cluster RCT and accounted for clustering in the sample size and analysis. All full studies reported the number of clusters randomized, and five reported intercluster correlation coefficients (50%): Protocols had higher compliance. Risk of bias was most evident in unblinding of participants. Statistician involvement was associated with improved trial quality and reporting. Quality of cluster RCTs of occupational therapy interventions is comparable with those from other areas of health research and needs improvement. © The Author(s) 2015.
Deshauer, D; Fergusson, D; Duffy, A; Albuquerque, J; Grof, P
The reported reduction of lithium's efficacy in the prophylaxis of bipolar illness has been attributed to various factors, including diagnostic changes and heterogeneous study designs. We attempted to quantify the impact of pre-randomization enrichment designs and diagnostic drift on randomized controlled trials (RCTs) of lithium maintenance therapy. Using the Cochrane RCT search filter, MEDLINE, EMBASE, and PSYCHINFO were searched (1966 to June 2004) for all available randomized studies using the text word 'lithium'. Studies of 1 year minimum duration in bipolar disorder involving lithium and placebo arms were identified. Superiority trials without a placebo arm, discontinuation and mirror image studies were excluded. Standardized scales were used to assess randomization and allocation concealment. Nine RCTs enrolling 1432 bipolar I and II patients, randomizing 341 to lithium and 386 to placebo were identified, with 705 reported pre-randomization dropouts. The pooled odds of remaining recurrence free in two non-enriched RCTS using Research Diagnostic Criteria (RDC) or Feighner criteria were 3.2:1 (95% CI 0.65--15.46) trending in favor of lithium over placebo, and 22.0:1 (95% CI 7.0--68.7) for three trials using lithium enrichment and excluding atypical bipolar disorder. The odds of remaining recurrence free using DSM-IV criteria and lamotrigine enrichment were 1.9:1 (95% CI 1.2-2.8). Lithium maintenance RCTs differ in patient selection, design, and outcome. A cohort effect can be associated with the use of pre-randomization enrichment phases and, to a lesser extent, with diagnostic drift, compromising straightforward comparisons across three decades of lithium monotherapy in bipolar illness.
Pinto, Rafael Zambelli; Elkins, Mark R; Moseley, Anne M; Sherrington, Catherine; Herbert, Robert D; Maher, Christopher G; Ferreira, Paulo H; Ferreira, Manuela L
Clinical trial registration has several putative benefits: prevention of selective reporting, avoidance of duplication, encouragement of participation, and facilitation of reviews. Previous surveys suggest that most trials are registered. However, these surveys examined only trials in journals with high impact factors, which may bias the results. This study examined the completeness of clinical trial registration and the extent of selective reporting of outcomes in a random sample of published randomized trials in physical therapy. This was a retrospective cohort study in which 200 randomized trials of physical therapy interventions were randomly selected from those published in 2009 and indexed in the Physiotherapy Evidence Database (PEDro), regardless of the publishing journal. Evidence of registration was sought for each trial in the study, on clinical trial registers, and by contacting authors. The proportion of randomized trials that were registered was 67/200 (34%). This proportion was significantly lower than among the trials in journals with high impact factors, where the proportion was 75% (odds ratio=7.4, 95% confidence interval=2.6-21.4). Unambiguous primary outcomes (ie, method and time points of measurement clearly defined in the trial registry entry) were registered for 32 trials, and registration was adequate (ie, prospective with unambiguous primary outcomes) for 5/200 (2.5%) trials. Selective outcome reporting occurred in 23 (47%) of the 49 trials in which selective reporting was assessable. The inclusion of only English-language trials prevents generalization of the results to non-English-language trials. Registration of randomized trials of physical therapy interventions is rarely adequate. Consequently, the putative benefits of registration are not being fully realized.
Siepe, Bettina; Hoilund-Carlsen, Poul Flemming; Gerke, Oke
an important role in informing guideline developers and policy makers. Our aim was to investigate how far the nuclear medicine community has come on its way from accuracy studies to RCTs and which issues we have to take into account in planning future studies. METHODS: We conducted a systematic review...... of diagnostic randomized trials, in which PET was applied in only one arm. We covered published studies as well as registered unpublished and planned studies. We considered 3 quality indicators related to the usefulness of a trial to generate evidence for a clinical benefit: use of patient-important outcome......, sufficient sample size, and current standard as comparator. RESULTS: Fourteen published and 15 planned studies were identified. Five of the published studies and 12 of the planned studies did not use a patient-important outcome. Sample sizes were often so small that a significant result could be expected...
Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.
Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014;37(9):1553-1563. PMID:25142566
Poh, Catherine F; Durham, J Scott; Brasher, Penelope M; Anderson, Donald W; Berean, Kenneth W; MacAulay, Calum E; Lee, J Jack; Rosin, Miriam P
Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in
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
Miller, William R; Yahne, Carolina E; Tonigan, J Scott
Motivational interviewing (MI) is a directive, client-centered brief intervention to elicit behavior change by helping clients explore and resolve ambivalence. In this clinical trial, 152 outpatients and 56 inpatients entering public agencies for treatment of drug problems were randomly assigned to receive or not receive a single session of manual-guided MI. Drug use was assessed by self-report, urine toxicology, and collateral reports from significant others at baseline, 3, 6, 9, and 12 months. Contrary to prior reports, MI showed no effect on drug use outcomes when added to inpatient or outpatient treatment, although both groups showed substantial increases in abstinence from illicit drugs and alcohol.
Kjaergard, Lise L; Gluud, Christian
-1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index....... There was a significant positive association between a statistically significant study outcome and the citation frequency (beta, 0.55, 95% confidence interval, 0.39-0.72). The disease area and adequate generation of the allocation sequence were also significant predictors of the citation frequency. We concluded...
Lund, Henrik Hautop; Jessen, Jari Due
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...
Ojo-Fati, Olamide; Joseph, Anne M; Ig-Izevbekhai, Jed; Thomas, Janet L; Everson-Rose, Susan A; Pratt, Rebekah; Raymond, Nancy; Cooney, Ned L; Luo, Xianghua; Okuyemi, Kolawole S
There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical concerns about conducting research with this population. This report is based on our experience and lessons learned while conducting two large NIH-funded randomized controlled trials targeting smoking cessation among persons who are homeless. The current report also addresses challenges when conducting clinical trials among homeless populations and offers potential solutions. Homeless individuals face several challenges including the need to negotiate daily access to food, clothing, and shelter. Some of the critical issues investigators encounter include recruitment and retention obstacles; cognitive impairment, mental health and substance abuse disorders; transportation and scheduling challenges; issues pertaining to adequate study compensation; the need for safety protocols for study staff; and issues related to protecting the wellbeing of these potentially vulnerable adults. Anticipating realistic conditions in which to conduct studies with participants who are homeless will help investigators to design efficient protocols and may improve the feasibility of conducting clinical trials involving homeless populations and the quality of the data collected by the researchers. ClinicalTrials.gov, ID: NCT00786149 . Registered on 5 November 2008; ClinicalTrials.gov, ID: NCT01932996 . Registered on 20 November 2014.
Full Text Available Abstract Background Attrition, which leads to missing data, is a common problem in cluster randomized trials (CRTs, where groups of patients rather than individuals are randomized. Standard multiple imputation (MI strategies may not be appropriate to impute missing data from CRTs since they assume independent data. In this paper, under the assumption of missing completely at random and covariate dependent missing, we compared six MI strategies which account for the intra-cluster correlation for missing binary outcomes in CRTs with the standard imputation strategies and complete case analysis approach using a simulation study. Method We considered three within-cluster and three across-cluster MI strategies for missing binary outcomes in CRTs. The three within-cluster MI strategies are logistic regression method, propensity score method, and Markov chain Monte Carlo (MCMC method, which apply standard MI strategies within each cluster. The three across-cluster MI strategies are propensity score method, random-effects (RE logistic regression approach, and logistic regression with cluster as a fixed effect. Based on the community hypertension assessment trial (CHAT which has complete data, we designed a simulation study to investigate the performance of above MI strategies. Results The estimated treatment effect and its 95% confidence interval (CI from generalized estimating equations (GEE model based on the CHAT complete dataset are 1.14 (0.76 1.70. When 30% of binary outcome are missing completely at random, a simulation study shows that the estimated treatment effects and the corresponding 95% CIs from GEE model are 1.15 (0.76 1.75 if complete case analysis is used, 1.12 (0.72 1.73 if within-cluster MCMC method is used, 1.21 (0.80 1.81 if across-cluster RE logistic regression is used, and 1.16 (0.82 1.64 if standard logistic regression which does not account for clustering is used. Conclusion When the percentage of missing data is low or intra
Coyle, Karin K.; Kirby, Douglas B.; Robin, Leah E.; Banspach, Stephen W.; Baumler, Elizabeth; Glassman, Jill R.
This study evaluated All4You!, a theoretically based curriculum designed to reduce sexual risk behaviors associated with HIV, other STDs, and unintended pregnancy among students in alternative schools. The study featured a randomized controlled trial involving 24 community day schools in northern California. A cohort of 988 students was assessed…
Gordon, Michael S.; Kinlock, Timothy W.; Couvillion, Kathryn A.; Schwartz, Robert P.; O'Grady, Kevin
The present report is an intent-to-treat analysis involving secondary data drawn from the first randomized clinical trial of prison-initiated methadone in the United States. This study examined predictors of treatment entry and completion in prison. A sample of 211 adult male prerelease inmates with preincarceration heroin dependence were randomly…
Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A
Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.
Campus, G; Carta, G; Cagetti, M G; Bossù, M; Sale, S; Cocco, F; Conti, G; Nardone, M; Sanna, G; Strohmenger, L; Lingström, P
A randomized clinical trial was performed in schoolchildren (6-7 yrs) to evaluate fluoride concentration in interproximal fluid after the placement of 3 different sealants. The sample consisted of 2,776 children randomly divided: 926 in the high-viscosity Glass-ionomer Cement group (GIC group), 923 in the fluoride Resin-based group (fluoride-RB group), and 927 in the no-fluoride Resin-based group (RB group). In total, 2,640 children completed the trial. Sealants were applied following manufacturer's instructions. Interproximal fluid samples were collected at baseline and 2, 7, and 21 days after application of sealants, by insertion of a standardized paperpoint into the interproximal mesial space of the sealed tooth for 15 seconds. Fluoride concentration was evaluated by means of a fluoride ion-selective electrode. At 2 days after sealant application, fluoride concentration was significantly higher in GIC and fluoride-RB groups compared with that in the RB group (p sealants increased the fluoride concentrations in interproximal fluid more than did a Resin-based sealant containing fluoride.
Cooper, Mark A; Lindsay, Grace M; Kinn, Sue; Swann, Ian J
Emergency Nurse Practitioners (ENP) are increasingly managing minor injuries in Accident and Emergency departments across the United Kingdom. This study aimed to develop methods and tools that could be used to measure the quality of ENP-led care. These tools were then tested in a randomized controlled trial. A convenience sample of 199 eligible patients, over 16 years old, and with specific minor injuries was randomized either to ENP-led care (n = 99) or Senior House Officer (SHO)-led care (n = 100) and were diagnosed, treated, referred or discharged by this lead clinician. Following treatment, patients were asked to complete a patient satisfaction questionnaire related to the consultation. Clinical documentation was assessed using a 'Documentation Audit Tool'. A follow-up questionnaire was sent to all patients at 1 month. Return visits to the department and missed injuries were monitored. Patients were satisfied with the level of care from both ENPs and SHOs. However, they reported that ENPs were easier to talk to (P = 0.009); gave them information on accident and illness prevention (P = 0.001); and gave them enough information on their injury (P = 0.007). Overall they were more satisfied with the treatment provided by ENPs than with that from SHOs (P trial could be used in Accident and Emergency departments to measure the quality of ENP-led care.
Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra
Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.
Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D
Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board
Goodman, Phyllis J; Hartline, Jo Ann; Tangen, Catherine M; Crowley, John J; Minasian, Lori M; Klein, Eric A; Cook, Elise D; Darke, Amy K; Arnold, Kathryn B; Anderson, Karen; Yee, Monica; Meyskens, Frank L; Baker, Laurence H
The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled prostate cancer prevention study funded by the National Cancer Institute (NCI) and conducted by the Southwest Oncology Group (SWOG). A total of 35,533 men were assigned randomly to one of the four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, and placebo + placebo). The independent Data and Safety Monitoring Committee (DSMC) recommended the discontinuation of study supplements because of the lack of efficacy for risk reduction and because futility analyses demonstrated no possibility of benefit of the supplements to the anticipated degree (25% reduction in prostate cancer incidence) with additional follow-up. Study leadership agreed that the randomized trial should be terminated but believed that the cohort should be maintained and followed as the additional follow-up would contribute important information to the understanding of the biologic consequences of the intervention. Since the participants no longer needed to be seen in person to assess acute toxicities or to be given study supplements, it was determined that the most efficient and cost-effective way to follow them was via a central coordinated effort. A number of changes were necessary at the local Study Sites and SELECT Statistical Center to transition to following participants via a Central Coordinating Center. We describe the transition process from a randomized clinical trial to the observational Centralized Follow-Up (CFU) study. The process of transitioning SELECT, implemented at more than 400 Study Sites across the United States, Canada, and Puerto Rico, entailed many critical decisions and actions including updates to online documents such as the SELECT Workbench and Study Manual, a protocol amendment, reorganization of the Statistical Center, creation of a Transition Committee, development of materials for SELECT Study Sites, development of procedures
Tickle, M; O'Neill, C; Donaldson, M; Birch, S; Noble, S; Killough, S; Murphy, L; Greer, M; Brodison, J; Verghis, R; Worthington, H V
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
Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick
Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.
PETRELLA, ROBERT J.; GILL, DAWN P.; ZOU, GUANGYONG; DE CRUZ, ASHLEIGH; RIGGIN, BRENDAN; BARTOL, CASSANDRA; DANYLCHUK, KAREN; HUNT, KATE; WYKE, SALLY; GRAY, CINDY M.; BUNN, CHRISTOPHER; ZWARENSTEIN, MERRICK
ABSTRACT Introduction Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Methods Male fans of two ice hockey teams (35–65 yr; body mass index ≥28 kg·m−2) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Results Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, −5.26 to −1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Conclusions Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial. PMID:28719494
Full Text Available Abstract Background Magnesium (Mg deficiency is common among alcoholics. Earlier research suggests that Mg treatment may help to normalize elevated enzyme activities and some other clinically relevant parameters among alcoholics but the evidence is weak. Methods The effect of Mg was studied in a randomized, parallel group, double-blind trial. The patients were first treated for alcohol withdrawal symptoms and then received for 8 weeks either 500 mg of Mg divided into two tablets or matching placebo. Measurements were made at the beginning and in the end of the Mg treatment period. The primary outcome was serum gamma-glutamyltransferase (S-GGT activity; secondary outcomes included aspartate-aminotransferase (S-AST and alanine-aminotransferase (S-ALT activity. Results The number of randomized patients (completers was 64 (27 in the treatment and 54 (31 in the control group. In intention-to-treat-analyses and in most analyses of study completers, there were no significant differences between the Mg-treated and placebo groups in the outcome variables. When baseline serum Mg level, coffee intake, and the number of unused Mg tablets were controlled for in a multivariate regression model, after-treatment serum Mg levels were found to be higher among the Mg-treated group than in the placebo group (t-test 3.334, df = 53, p = 0.002. After controlling for age, body weight, baseline alcohol intake, subsequent change in alcohol intake and baseline S-AST, the after-treatment S-AST levels were found to be lower among the Mg-treated group than in the placebo group (t-test 2.061, df = 49, p = 0.045. Conclusion Mg treatment may speed up the S-AST decrease in compliant patients. This might decrease the risk of death from alcoholic liver disease. Trial Registration ClinicalTrials.gov ID NCT00325299
Lin, Yunzhi; Zhu, Ming; Su, Zheng
Randomization is fundamental to the design and conduct of clinical trials. Simple randomization ensures independence among subject treatment assignments and prevents potential selection biases, yet it does not guarantee balance in covariate distributions across treatment groups. Ensuring balance in important prognostic covariates across treatment groups is desirable for many reasons. A broad class of randomization methods for achieving balance are reviewed in this paper; these include block randomization, stratified randomization, minimization, and dynamic hierarchical randomization. Practical considerations arising from experience with using the techniques are described. A review of randomization methods used in practice in recent randomized clinical trials is also provided. Copyright © 2015 Elsevier Inc. All rights reserved.
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.
Boyer, Holly; Fernandes, Patricia; Le, Chap; Yueh, Bevan
Our previous studies have demonstrated the tolerability and low side-effect profile of office-based sclerotherapy with sodium tetradecyl sulfate (STS) for treating recurrent epistaxis due to hereditary hemorrhagic telangiectasia (HHT). The objective of this study was to use a prospective randomized trial to determine the effectiveness of sclerotherapy with STS vs standard treatment. This prospective randomized trial (conducted from November 1, 2011, through January 31, 2014) involved 17 patients with recurrent epistaxis due to HHT. We defined standard treatment as continuation of any treatment that the patient had previously undergone, such as moisturization, packing, and cautery. We used a crossover design, so study participants were randomized to either sclerotherapy or standard treatment during the first time period, and then to the other during the second period. The primary outcome measure was frequency and severity of epistaxis, as measured by the epistaxis severity score (ESS). The ESS is a 10-point scale, with higher scores corresponding to more bleeding. After controlling for treatment order, bleeding was substantially better controlled after sclerotherapy; the ESS after sclerotherapy was nearly one point lower than after standard treatment (-0.95, 1-sided p = 0.027). Treatment order, baseline ESS, the number of lesions, moisturization practices, and a history of previous blood transfusions did not significantly affect the results. This trial demonstrated that sclerotherapy with STS (vs standard treatment) significantly reduced epistaxis due to HHT. © 2015 ARS-AAOA, LLC.
William F. Clark
Full Text Available Background: In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown. Objective: To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR in patients with chronic kidney disease. Design: Parallel-group randomized controlled trial. Setting: Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017. Participants: Adults (n = 631 with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m 2 and microalbuminuria. Intervention: The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight, over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time. Measures: Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet. Primary outcome: The between-group change in eGFR from baseline (prerandomization to 12 months after randomization. Secondary outcomes: Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation, and health-related quality of life. Planned analysis: The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using
Árni Gunnar Ásgeirsson
Full Text Available Consistent financial reward of particular features influences the allocation of visual attention in many ways. More surprising are 1-trial reward priming effects on attention where reward schedules are random and reward on one trial influences attentional allocation on the next. Those findings are thought to reflect that rewarded features become more salient than unrewarded ones on the subsequent trial. Here we attempt to conceptually replicate this effect, testing its generalizability. In three versions of an analogous paradigm to the additional singleton paradigm involving singleton search for a Gabor patch of odd spatial frequency we found no evidence of reward priming, while we only partially replicate the reward priming in the exact original paradigm tested by Hickey and colleagues. The results cast doubt on the proposal that random reward enhances salience, suggested in the original papers, and highlight the need for a more nuanced account. In many other paradigms reward effects have been found to progress gradually, becoming stronger as they build up, and we argue that for robust reward priming, reward schedules need to be more consistent than in the original 1-trial reward priming paradigm.
Park, H C; Kim, M J; Lee, B H
Uncomplicated appendicitis may resolve spontaneously or require treatment with antibiotics or appendicectomy. The aim of this randomized trial was to compare the outcome of a non-antibiotic management strategy with that of antibiotic therapy in uncomplicated appendicitis. Patients presenting to a university teaching hospital with CT-verified uncomplicated simple appendicitis (appendiceal diameter no larger than 11 mm and without any signs of perforation) were randomized to management with a no-antibiotic regimen with supportive care (intravenous fluids, analgesia and antipyretics as necessary) or a 4-day course of antibiotics with supportive care. The primary endpoint was rate of total treatment failure, defined as initial treatment failure within 1 month and recurrence of appendicitis during the follow-up period. Some 245 patients were randomized within the trial, and followed up for a median of 19 months. The duration of hospital stay was shorter (mean 3·1 versus 3·7 days; P therapy without antibiotics. There was no difference in total treatment failure rate between the groups: 29 of 124 (23·4 per cent) in the no-antibiotic group and 25 of 121 (20·7 per cent) in the antibiotic group (P = 0·609). Eighteen patients (9 in each group) had initial treatment failure, 15 of whom underwent appendicectomy and three received additional antibiotics. Thirty-six patients (20 in the no-antibiotic group, 16 in the antibiotic group) experienced recurrence, of whom 30 underwent appendicectomy and six received further antibiotics. Treatment failure rates in patients presenting with CT-confirmed uncomplicated appendicitis appeared similar among those receiving supportive care with either a no-antibiotic regimen or a 4-day course of antibiotics. Registration number: KCT0000124 ( http://cris.nih.go.kr). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.
Hasselbalch, Rasmus Bo; Plesner, Louis Lind; Pries-Heje, Mia; Ravn, Lisbet; Lind, Morten; Greibe, Rasmus; Jensen, Birgitte Nybo; Rasmussen, Lars S; Iversen, Kasper
Crowding in the emergency department (ED) is a well-known problem resulting in an increased risk of adverse outcomes. Effective triage might counteract this problem by identifying the sickest patients and ensuring early treatment. In the last two decades, systematic triage has become the standard in ED's worldwide. However, triage models are also time consuming, supported by limited evidence and could potentially be of more harm than benefit. The aim of this study is to develop a quicker triage model using data from a large cohort of unselected ED patients and evaluate if this new model is non-inferior to an existing triage model in a prospective randomized trial. The Copenhagen Triage Algorithm (CTA) study is a prospective two-center, cluster-randomized, cross-over, non-inferiority trial comparing CTA to the Danish Emergency Process Triage (DEPT). We include patients ≥16 years (n = 50.000) admitted to the ED in two large acute hospitals. Centers are randomly assigned to perform either CTA or DEPT triage first and then use the other triage model in the last time period. The CTA stratifies patients into 5 acuity levels in two steps. First, a scoring chart based on vital values is used to classify patients in an immediate category. Second, a clinical assessment by the ED nurse can alter the result suggested by the score up to two categories up or one down. The primary end-point is 30-day mortality and secondary end-points are length of stay, time to treatment, admission to intensive care unit, and readmission within 30 days. If proven non-inferior to standard DEPT triage, CTA will be a faster and simpler triage model that is still able to detect the critically ill. Simplifying triage will lessen the burden for the ED staff and possibly allow faster treatment. Clinicaltrials.gov: NCT02698319 , registered 24. of February 2016, retrospectively registered.
Full Text Available Parkinson's disease (PD is a common and debilitating neurodegenerative disorder that needs long-term levodopa administration and can result in progressive deterioration of body functions, daily activities and participation. The objective of this meta-analysis evaluates the clinical efficacy and safety of Chinese herbal medicine (CHM as an adjunct therapy for PD patients. Methodological issues include a systematic literature search between 1950 and April 2011 to identify randomized trials involving CHM adjuvant therapy versus western conventional treatment. The outcome measures assessed were the reduction in scores of Unified Parkinson's Disease Rating Scale (UPDRS and adverse effects. 19 trials involving 1371 participants were included in the meta-analysis. As compared to western conventional treatment, CHM adjuvant therapy resulted in greater improvement in UPDRS I, II, III, IV scores, and UPDRS I–IV total scores (P<0.001. Adverse effects were reported in 9 studies. The side effects in CHM adjuvant therapy group were generally less than or lighter than the conventional treatment group. In conclusion, CHM adjuvant therapy may potentially alleviate symptoms of PD and generally appeared to be safe and well tolerated by PD patients. However, well-designed, randomized, placebo-controlled clinical trials are still needed due to the generally low methodological quality of the included studies.
Callahan, Christopher M; Boustani, Malaz A; Schmid, Arlene A; LaMantia, Michael A; Austrom, Mary G; Miller, Douglas K; Gao, Sujuan; Ferguson, Denisha Y; Lane, Kathleen A; Hendrie, Hugh C
Alzheimer disease results in progressive functional decline, leading to loss of independence. To determine whether collaborative care plus 2 years of home-based occupational therapy delays functional decline. Randomized, controlled clinical trial. (ClinicalTrials.gov: NCT01314950). Urban public health system. 180 community-dwelling participants with Alzheimer disease and their informal caregivers. All participants received collaborative care for dementia. Patients in the intervention group also received in-home occupational therapy delivered in 24 sessions over 2 years. The primary outcome measure was the Alzheimer's Disease Cooperative Study Group Activities of Daily Living Scale (ADCS ADL); performance-based measures included the Short Physical Performance Battery (SPPB) and Short Portable Sarcopenia Measure (SPSM). At baseline, clinical characteristics did not differ significantly between groups; the mean Mini-Mental State Examination score for both groups was 19 (SD, 7). The intervention group received a median of 18 home visits from the study occupational therapists. In both groups, ADCS ADL scores declined over 24 months. At the primary end point of 24 months, ADCS ADL scores did not differ between groups (mean difference, 2.34 [95% CI, -5.27 to 9.96]). We also could not definitively demonstrate between-group differences in mean SPPB or SPSM values. The results of this trial are indeterminate and do not rule out potential clinically important effects of the intervention. The authors could not definitively demonstrate whether the addition of 2 years of in-home occupational therapy to a collaborative care management model slowed the rate of functional decline among persons with Alzheimer disease. This trial underscores the burden undertaken by caregivers as they provide care for family members with Alzheimer disease and the difficulty in slowing functional decline. National Institute on Aging.
Full Text Available The seventh edition of the American Academy of Pediatrics Neonatal Resuscitation Program recommends the use of a cardiac monitor in infants that need resuscitation. Previous trials have shown that EKG heart rate is available before pulse rate from a pulse oximeter. To date no trial has looked at how the availability of electrocardiogram (EKG affects clinical interventions in the delivery room.To determine whether the availability of an EKG heart rate value and tracing to the clinical team has an effect on physiologic measures and related interventions during the stabilization of preterm infants.Forty (40 premature infants enrolled in a neuro-monitoring study (The Neu-Prem Trial: NCT02605733 who had an EKG monitor available were randomized to have the heart rate information from the bedside EKG monitor either displayed or not displayed to the clinical team. Heart rate, oxygen saturation, FiO2 and mean airway pressure from a data acquisition system were recorded every 2 seconds. Results were averaged over 30 seconds and the differences analyzed using two-tailed t-test. Interventions analyzed included time to first change in FiO2, first positive pressure ventilation, first increase in airway pressure, and first intubation.There were no significant differences in time to clinical interventions between the blinded and unblinded group, despite the unblinded group having access to a visible heart rate at 66 +/- 20 compared to 114 +/- 39 seconds for the blinded group (p < .0001. Pulse rate from oximeter was lower than EKG heart rate during the first 2 minutes of life, but this was not significant.EKG provides an earlier, and more accurate heart rate than pulse rate from an oximeter during stabilization of preterm infants, allowing earlier intervention. All interventions were started earlier in the unblinded EKG group but these numbers were not significant in this small trial. Earlier EKG placement before pulse oximeter placement may affect other
McNicholas, Colleen P.; Madden, Tessa; Zhao, Qiuhong; Secura, Gina; Allsworth, Jenifer E.; Peipert, Jeffrey F.
Objective Anticipated pain with intrauterine device (IUD) insertion may be a barrier to widespread use. Our objective was to evaluate the efficacy of intracervical 2% lidocaine gel for pain relief with IUD insertion. Study Design We performed a double-blind, randomized controlled trial of women undergoing IUD insertion. Participants were randomly assigned to 2% lidocaine or placebo gel. Study gel (3ccs) wase placed 3 minutes prior to IUD insertion. Pain scores were measured at various time points using a 10-point visual analog scale. Results Of the 200 participants randomized, 199 completed the study. Pain scores among lidocaine and placebo arms were similar at tenaculum placement (lidocaine and placebo; median 4, range 0–10 p=0.15) as well as with insertion (lidocaine: median 5 range 1–10, placebo: median 6 range 0–10 p=0.16). These results did not differ by parity. Conclusions Topical or intracervical 2% lidocaine gel prior to IUD insertion does not decrease pain scores. PMID:23107081
Full Text Available In this trial, patients who agreed to random assignment were allocated to a randomized acupuncture group (R-acupuncture group or control group. Those who declined randomization were assigned to a nonrandomized acupuncture group (NR-acupuncture group. Patients in the R-acupuncture group and NR-acupuncture group received up to 21 acupuncture sessions during a period of 6 weeks plus routine care, while the control group received routine care alone. Cognitive function, activities of daily living, and quality of life were assessed by mini-mental state examination (MMSE, Activities of Daily Living Scale (ADL, and dementia quality of life questionnaire (DEMQOL, respectively. All the data were collected at baseline, after 6-week treatment, and after 4-week follow-up. No significant differences of MMSE scores were observed among the three groups but pooled-acupuncture group had significant higher score than control group. Compared to control group, ADL score significantly decreased in NR-acupuncture group and pooled-acupuncture group. For DEMQOL scores, no significant differences were observed among the three groups, as well as between pooled-acupuncture group and control group. Additional acupuncture to routine care may have beneficial effects on the improvements of cognitive status and activities of daily living but have limited efficacy on health-related quality of life in VaD patients.
Shi, Guang-Xia; Li, Qian-Qian; Yang, Bo-Feng; Liu, Yan; Guan, Li-Ping; Wu, Meng-Meng; Wang, Lin-Peng; Liu, Cun-Zhi
In this trial, patients who agreed to random assignment were allocated to a randomized acupuncture group (R-acupuncture group) or control group. Those who declined randomization were assigned to a nonrandomized acupuncture group (NR-acupuncture group). Patients in the R-acupuncture group and NR-acupuncture group received up to 21 acupuncture sessions during a period of 6 weeks plus routine care, while the control group received routine care alone. Cognitive function, activities of daily living, and quality of life were assessed by mini-mental state examination (MMSE), Activities of Daily Living Scale (ADL), and dementia quality of life questionnaire (DEMQOL), respectively. All the data were collected at baseline, after 6-week treatment, and after 4-week follow-up. No significant differences of MMSE scores were observed among the three groups but pooled-acupuncture group had significant higher score than control group. Compared to control group, ADL score significantly decreased in NR-acupuncture group and pooled-acupuncture group. For DEMQOL scores, no significant differences were observed among the three groups, as well as between pooled-acupuncture group and control group. Additional acupuncture to routine care may have beneficial effects on the improvements of cognitive status and activities of daily living but have limited efficacy on health-related quality of life in VaD patients.
Magnusson, Peter; Wennström, Leo; Kastberg, Robert; Liv, Per
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. 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). 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.
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
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
Callahan Christopher M
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
Barr, Colin; Marois, Maria; Sim, Ida; Schmid, Christopher H; Wilsey, Barth; Ward, Deborah; Duan, Naihua; Hays, Ron D; Selsky, Joshua; Servadio, Joseph; Schwartz, Marc; Dsouza, Clyde; Dhammi, Navjot; Holt, Zachary; Baquero, Victor; MacDonald, Scott; Jerant, Anthony; Sprinkle, Ron; Kravitz, Richard L
Chronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the 'Trialist' mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain. A randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks. Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach. ClinicalTrials.gov: NCT02116621 , first registered 15 April 2014.
Tappin David M
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
Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian
The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....
Chhangur Rabia R
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
Zakeri, Kaveh; Rose, Brent S.; D’Amico, Anthony V.; Jeong, Jong-Hyeon; Mell, Loren K.
Background: Clinical trial costs may be reduced by identifying enriched subpopulations of patients with favorable risk profiles for the events of interest. However, increased selectivity affects accrual rates, with uncertain impact on clinical trial cost. Methods: We conducted a secondary analysis of Southwest Oncology Group (SWOG) 8794 randomized trial of adjuvant radiotherapy for high-risk prostate cancer. The primary endpoint was metastasis-free survival (MFS), defined as time to metastasis or death from any cause (competing mortality). We used competing risks regression models to identify an enriched subgroup at high risk for metastasis and low risk for competing mortality. We applied a cost model to estimate the impact of enrichment on trial cost and duration. Results: The treatment effect on metastasis was similar in the enriched subgroup (HR, 0.42; 95% CI, 0.23–0.76) compared to the whole cohort (HR, 0.50; 95% CI, 0.30–0.81) while the effect on competing mortality was not significant in the subgroup or the whole cohort (HR 0.70; 95% CI 0.39–1.23, vs. HR 0.94; 95% CI, 0.68–1.31). Due to the higher incidence of metastasis relative to competing mortality in the enriched subgroup, the treatment effect on MFS was greater in the subgroup compared to the whole cohort (HR 0.55; 95% CI 0.36–0.82, vs. HR 0.77; 95% CI, 0.58–1.01). Trial cost was 75% less in the subgroup compared to the whole cohort ($1.7 million vs. $6.8 million), and the trial duration was 30% shorter (8.4 vs. 12.0 years). Conclusion: Competing event enrichment can reduce clinical trial cost and duration, without sacrificing generalizability
Lucas, Brian P; Candotti, Carolina; Margeta, Bosko; Mba, Benjamin; Kumapley, Rudolf; Asmar, Abdo; Franco-Sadud, Ricardo; Baru, Joshua; Acob, Christine; Borkowsky, Shane; Evans, Arthur T
Hospitalists can use hand-carried echocardiography for accurate point-of-care information, but patient outcome data for its application are sparse. We performed an unblinded, parallel-group randomized trial between July 2008 and March 2009 at one teaching hospital in Chicago, Illinois. We randomly assigned adult general medicine inpatients referred for standard echocardiography with indications investigatable by hand-carried echocardiography to care guided by hand-carried echocardiography or usual care. The main outcome measure was length of stay on the referring hospitalist's service. Secondary outcomes included a before-after analysis of reported changes in management due to hand-carried echocardiography and the diagnostic accuracy of hand-carried echocardiography. The difference in length of stay between 226 participants randomized to care guided by hand-carried echocardiography (geometric mean 46.1 hours, interquartile range 29.0-70.9 hours) and 227 participants randomized to usual care (46.9 hours, interquartile range 34.1-68.3 hours) corresponded to a 1.7% reduction in length of stay that was not statistically significant (95% confidence interval, -12.1 to 9.8%). In post hoc subgroup analyses, care guided by hand-carried echocardiography reduced length of stay in participants who were referred for heart failure (P=.0008). Among participants who underwent both hand-carried and standard echocardiography, hospitalists changed management due to hand-carried echocardiography in 37%. Despite the favorable diagnostic accuracy of hand-carried echocardiography, most changes to the timing of hospital discharge occurred after standard echocardiography. Hospitalist care guided by hand-carried echocardiography for unselected general medicine patients does not meaningfully affect length of stay. Whether or not it affects care quality remains unstudied. Copyright © 2011 Elsevier Inc. All rights reserved.
Glavind, Julie; Kindberg, Sara Fevre; Uldbjerg, Niels
Objective Neonatal complications related to timing of elective cesarean section (ECS) have never been studied in randomized trials. We designed the first randomized trial of timing of ECS and hypothesized a decrease in neonatal admission rate if ECS was scheduled after 39 completed weeks of gesta......Objective Neonatal complications related to timing of elective cesarean section (ECS) have never been studied in randomized trials. We designed the first randomized trial of timing of ECS and hypothesized a decrease in neonatal admission rate if ECS was scheduled after 39 completed weeks...
Full Text Available Background. Acupoint stimulation is popular for treatment of fibromyalgia though there is lack of comprehensive evaluation of current clinical evidence for its effect and safety. Objective. To systematically review the beneficial effects and safety of acupoint stimulation for fibromyalgia. Methods. We searched six electronic databases for randomized trials on acupoint stimulation for treatment of fibromyalgia. Two authors extracted data and assessed the trial quality independently. RevMan 5.2 software was used for data analyses with effect estimate presented as (standard mean difference and a 95% confidence interval. We defined minimum, medium, and large SMD effect sizes as 0.3, 0.5, and 0.75. Results. 16 RCTs with 1081 participants were involved in this review. Only two trials were evaluated as low risk of bias. Meta-analysis showed that acupuncture alone or combined with cupping therapy was superior to conventional medications on reducing pain scores and/or the number of tender points. However, acupuncture showed no better than sham acupuncture on pain reduction. There was no serious adverse event reported to be related to acupoint stimulation. Conclusions. Acupoint stimulation appears to be effective in treating fibromyalgia compared with medications. However, further large, rigorously designed trials are warranted due to insufficient methodological rigor in the included trials.
Gilliss, C L; Neuhaus, J M; Hauck, W W
As part of a randomized clinical trial of in-hospital and postdischarge nursing interventions designed to facilitate the individual patient's recovery and improve the family's functioning after cardiac surgery, we followed 67 patient-spouse pairs for 6 months after surgery. Family health was appraised by using three pencil and paper measurements: the Family APGAR, the Locke-Wallace Marital Adjustment Scale, and the Family Inventory of Resources for Management. Mixed-effects analysis of variance did not detect differences for the main effect of intervention group; however, the main effect of time was significant for both patients' and spouses' APGAR scores and for patients' Marital Adjustment Scale scores, suggesting a pattern of response during recovery from cardiac surgery.
Paci, Matteo; Landi, Niccolò; Marchettini, Mariangela; Baccini, Marco
The aim of this study is to describe the reported quality of randomized controlled trials (RCTs) in pediatric physical therapy (PPT) and changes with time. All RCTs sourced from PEDro database and scored using the PEDro scale were included. RCTs were classified as high- or low quality both with the original cut-off of 6 and a modified cut-off of 5. The relationship between PEDro scores and year of publication was also investigated. One thousand three hundred sixty-seven articles were analyzed. According to the PEDro scale original and modified cut-off, 29% and 56% of the articles were classified as high-quality studies, respectively. The number of RCTs and the average PEDro score increased between 1962 and 2012. However, since some items of the scale could be more frequently satisfied, a further improvement of the quality of RCTs in PPT is recommended.
Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine
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.
Page, Matthew J.; Higgins, Julian P. T.; Clayton, Gemma
search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta......-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR ...) characteristic. Results: We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7...
Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten
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...
In recent years a growing number of professional philosophers have joined in the controversy over ethical aspects of randomized clinical trials (RCTs). Morally questionable in their utilitarian approach, RCTs are claimed by some to be in direct violation of the second form of Kant's Categorical Imperative. But the arguments used in these critiques at times derive from a lack of insight into basic statistical procedures and the realities of the biomedical research process. Presented to physicians and other nonspecialists, including the lay public, such distortions can be harmful. Given the great complexity of statistical methodology and the anomalous nature of concepts of evidence, more sustained input into the interdisciplinary dialogue is needed from the statistical profession.
Kinnison, M.L.; Powe, N.R.; Steinberg, E.P.
The authors review 100 randomized controlled trials (RCTs) that examine the safety or efficacy of new low-osmolality contrast media (LOM) and focus on the 43 RCTs judged to be of the highest quality. These RCTs showed no consistent differences in nephrotoxicity between high- and low-osmolality contrast media. Certain cardiovascular parameters were altered less with low-osmolality agents during intracardiac injection, but the clinical significance of these differences in unclear. Heat and pain sensations occurred less often with low-osmolality contrast media. No differences were noted in the incidence of nausea, vomiting, urticaria, or bronchospasm. Even with numerous RCTs comparing these media, physicians still must make economically significant choices about contrast media without sufficient data about their relative safety
Fleischmann, Robert; Decker, Anne-Marie; Kraft, Antje; Mai, Knut; Schmidt, Sein
Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity. This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics. All randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F (1,112) = .15, p = .699), CRF length (F (2,112) = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was
Daniela Francescato Veiga
Full Text Available The evidence to support dressing standards for breast surgery wounds is empiric and scarce.This two-arm randomized clinical trial was designed to assess the effect of dressing wear time on surgical site infection (SSI rates, skin colonization and patient perceptions.A total of 200 breast cancer patients undergoing breast reconstruction were prospectively enrolled. Patients were randomly allocated to group I (dressing removed on the first postoperative day, n = 100 or group II (dressing removed on the sixth postoperative day, n = 100. SSIs were defined and classified according to criteria from the Centers for Disease Control and Prevention. Samples collected before placing the dressing and after 1 day (group I and 6 days (both groups were cultured for skin colonization assessments. Patients preferences and perceptions with regard to safety, comfort and convenience were recorded and analyzed.A total of 186 patients completed the follow-up. The global SSI rate was 4.5%. Six patients in group I and three in group II had SSI (p = 0.497. Before dressing, the groups were similar with regard to skin colonization. At the sixth day, there was a higher colonization by coagulase-negative staphylococci in group I (p<0.0001. Patients preferred to keep dressing for six days (p<0.0001, and considered this a safer choice (p<0.05.Despite group I had a higher skin colonization by coagulase-negative staphylococci on the sixth postoperative day, there was no difference in SSI rates. Patients preferred keeping dressing for six days and considered it a safer choice.ClinicalTrials.gov NCT01148823.
Tuuli, Methodius G; Liu, Jingxia; Stout, Molly J; Martin, Shannon; Cahill, Alison G; Odibo, Anthony O; Colditz, Graham A; Macones, George A
Preoperative skin antisepsis has the potential to decrease the risk of surgical-site infection. However, evidence is limited to guide the choice of antiseptic agent at cesarean delivery, which is the most common major surgical procedure among women in the United States. In this single-center, randomized, controlled trial, we evaluated whether the use of chlorhexidine-alcohol for preoperative skin antisepsis was superior to the use of iodine-alcohol for the prevention of surgical-site infection after cesarean delivery. We randomly assigned patients undergoing cesarean delivery to skin preparation with either chlorhexidine-alcohol or iodine-alcohol. The primary outcome was superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of definitions from the Centers for Disease Control and Prevention. From September 2011 through June 2015, a total of 1147 patients were enrolled; 572 patients were assigned to chlorhexidine-alcohol and 575 to iodine-alcohol. In an intention-to-treat analysis, surgical-site infection was diagnosed in 23 patients (4.0%) in the chlorhexidine-alcohol group and in 42 (7.3%) in the iodine-alcohol group (relative risk, 0.55; 95% confidence interval, 0.34 to 0.90; P=0.02). The rate of superficial surgical-site infection was 3.0% in the chlorhexidine-alcohol group and 4.9% in the iodine-alcohol group (P=0.10); the rate of deep infection was 1.0% and 2.4%, respectively (P=0.07). The frequency of adverse skin reactions was similar in the two groups. The use of chlorhexidine-alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than did the use of iodine-alcohol. (Funded by the National Institutes of Health and Washington University School of Medicine in St. Louis; ClinicalTrials.gov number, NCT01472549.).
Fu, Cong; Zhao, Na; Liu, Zhen; Yuan, Lu-Hua; Xie, Chen; Yang, Wen-Jia; Yu, Xin-Tong; Yu, Huan; Chen, Yun-Fei
To evaluate the short-term efficacy of acupuncture for the treatment of peri-menopausal insomnia (PMI). Design: A randomized, participant-blind, placebo-controlled trial consisted of the acupuncture group (n = 38) and placebo-acupuncture group (n = 38). Setting: A tertiary teaching and general hospital. Participants: 76 peri-menopausal women with insomnia disorder based on the International Classification of Sleep Disorders, Third Edition. Interventions: A 10-session of acupuncture at bilateral Shenshu (BL 23) and Ganshu (BL 18) with unilateral Qimen (LR 14) and Jingmen (GB 25) or Streitberger needles at the same acupoints was performed for over 3 weeks. Measurements: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with over-night polysomnography (PSG) exam were completed at baseline and post-treatment. After the treatments, the decrease from baseline in PSQI score was 8.03 points in acupuncture group and 1.29 points in placebo-acupuncture group. The change from baseline in ISI score was 11.35 points in acupuncture group and 2.87 points in placebo-acupuncture group. In PSG data, acupuncture significantly improved the sleep efficiency and total sleep time, associated with less wake after sleep onset and lower percent stage 1 after the treatment. No significant differences from baseline to post-treatment were found in placebo-acupuncture group. Acupuncture can contribute to a clinically relevant improvement in the short-term treatment of PMI, both subjectively and objectively. Acupuncture for peri-menopause insomnia: a randomized controlled trial, http://www.chictr.org.cn/showproj.aspx?proj=12118 ChiCTR-IPR-15007199, China. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail firstname.lastname@example.org.
Sharara-Chami, Rana; Lakissian, Zavi; Charafeddine, Lama; Milad, Nadine; El-Hout, Yaser
There is no consensus on the most effective pain management for neonatal circumcision. We sought to compare different modalities. This is a double-blinded randomized controlled trial comparing 3 combination analgesics used during circumcision (EMLA + sucrose; EMLA + sucrose + dorsal penile nerve block [DPNB]; EMLA + sucrose + ring block [RB]) with the traditional topical analgesic cream EMLA alone. The trial was set in the normal nursery of a teaching hospital. The sample included 70 healthy male newborns, randomly assigned to intervention and control groups at a 2:1 ratio. Infants were videotaped (face and torso) during the procedure for assessment of pain by 2 blinded, independent reviewers. The primary outcome measure is the Neonatal Infant Pain Scale score. Secondary outcomes include heart rate, oxygen saturation, and crying time. Neonatal Infant Pain Scale scores were significantly lower in the intervention groups (EMLA + sucrose, mean [SD]: 3.1 [1.33]; EMLA + sucrose + DPNB: 3 [1.33]; EMLA + sucrose + RB: 2.45 [1.27]) compared with the control (5.5 [0.53]). Between-group analyses showed RB + EMLA + sucrose to be significantly more effective than EMLA + sucrose; EMLA + sucrose + DPNB ( P = .009 and P = .002, respectively). Interrater reliability was κ = 0.843. Significant increase in heart rate (139.27 [9.63] to 163 [13.23] beats per minute) and crying time (5.78 [6.4] to 45.37 [12.39] seconds) were noted in the EMLA group. During neonatal circumcision in boys, the most effective analgesia is RB combined with oral sucrose and EMLA cream. Copyright © 2017 by the American Academy of Pediatrics.
Tappin, David M; Bauld, Linda; Tannahill, Carol; de Caestecker, Linda; Radley, Andrew; McConnachie, Alex; Boyd, Kathleen; Briggs, Andrew; Grant, Liz; Cameron, Alan; Macaskill, Susan; Sinclair, Lesley; Friel, Brenda; Coleman, Tim
Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: 'How to stop smoking in pregnancy and following childbirth' (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy.Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can
Lawton, Julia; Kirkham, Jackie; White, David; Rankin, David; Cooper, Cindy; Heller, Simon
The perspectives and experiences of trial staff are increasingly being investigated as these can be used to improve recruitment, adherence to trial protocols and support given to future staff. We interviewed staff working on a type 1 diabetes trial in order to aid interpretation of trial findings, inform recommendations for the rollout of the treatments investigated and provide recommendations for the conduct of future trials. However, our interviews uncovered aspects of trial work erstwhile unrecognised or underreported in the trials literature, and it is these which form the focus of this paper. In-depth interviews were conducted with (n = 18) staff, recruited from seven centres, who were involved in recruitment and trial delivery. Data were analysed thematically. Alongside logistical and practical issues which made trial work challenging, staff often talked spontaneously and at length about how trial work had affected them emotionally. Staff not only described the emotional stresses arising from having to meet recruitment targets and from balancing research roles with clinical responsibilities, they also discussed having to emotionally manage patients and their colleagues. The emotional aspects of trial work particularly came to the fore when staff notified patients about their treatment allocation. On such occasions, staff described having to employ emotional strategies to pre-empt and manage potential patient disappointment and anger. Staff also described having to manage their own emotions when patients withdrew from the trial or were not randomised to the treatment arm which, in their clinical judgment, would have been in their best interests. To help address the emotional challenges they encountered, staff highlighted a need for more practical, emotional and specialist psychological support. More attention should be paid to the emotional aspects of trial work to help ensure trial staff are adequately supported. Such support could comprise: increased
Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A
To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright Â© 2016 Elsevier Ltd. All rights reserved.
Guo, Jia-Wen; Sward, Katherine A; Beck, Susan L; Staggers, Nancy
Results of randomized controlled trials (RCTs) provide high-level evidence for evidence-based practice (EBP). The quality of RCTs has a substantial influence on providing reliable knowledge for EBP. Little is known about the quality of RCT reporting in cancer nursing. The aim of this study was to assess the quality of reporting in published cancer nursing RCTs from 1984 to 2010. A total of 227 RCTs in cancer nursing published in English-language journals and indexed in PubMed or Cumulative Index to Nursing and Allied Health Literature were reviewed using the Jadad scale, key methodologic index (KMI), and the Consolidated Standards of Reporting Trials (CONSORT) checklist to assess the quality of reporting methodological aspects of research and the overall quality of reporting RCTs. Adherence to reporting metrics was relatively low, based on the Jadad score (M = 1.94 out of 5, SD = 1.01), KMI scores (M = 0.84 out of 3, SD = .87), and adherence to CONSORT checklist items (M =16.92 out of 37, SD = 4.03). Only 11 of 37 items in the CONSORT checklist were reported in 80% or more of the studies reviewed. The quality of reporting showed some improvement over time. Adherence to reporting metrics for cancer nursing RCTs was suboptimal, and further efforts are needed to improve both methodology reporting and overall reporting. Journals are encouraged to adopt the CONSORT checklist to influence the quality of RCT reports.
Van Sciver, Angela; Mahnken, Jonathan D.; Honea, Robyn A.; Brooks, William M.; Billinger, Sandra A.; Swerdlow, Russell H.; Burns, Jeffrey M.
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
Corneli, Howard M; Zorc, Joseph J; Mahajan, Prashant; Majahan, Prashant; Shaw, Kathy N; Holubkov, Richard; Reeves, Scott D; Ruddy, Richard M; Malik, Baqir; Nelson, Kyle A; Bregstein, Joan S; Brown, Kathleen M; Denenberg, Matthew N; Lillis, Kathleen A; Cimpello, Lynn Babcock; Tsung, James W; Borgialli, Dominic A; Baskin, Marc N; Teshome, Getachew; Goldstein, Mitchell A; Monroe, David; Dean, J Michael; Kuppermann, Nathan
Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited. We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score > or =6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events. Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, -1.3%; 95% confidence interval [CI], -9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was -5.3 for dexamethasone, as compared with -4.8 for placebo (absolute difference, -0.5; 95% CI, -1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes. In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
Du, Wen-Fei; Yu, Lu; Yan, Xing-Ke; Wang, Fu-Chun
To assess the efficacy of acupuncture and moxibustion on constipation. A retrieval on literatures concerning treatment of constipation with acupuncture was carried out in databases of VIP, CNKI, WANFANG and PubMed. And meta-analyses were conducted on randomized controlled trial (RCT) and controlled clinical trial (CCT) which met the enrolling requirements. A total number of 15 papers involving 1 052 patients were concluded. The result indicated that the curative rate of acupuncture and moxibustion on constipation is better than ordinary medication (RR = 1.92, 95% CI 1.61-2.30, Z = 7.18, P singleness still exists in the index of assessment on therapeutic effect of constipation, and the number of RCT and CCT literatures, especially high-quality, large samples and multi-center reports were still not enough, further studies are still necessary for approving the above conclusions.
Christakis, Dimitri A; Zimmerman, Frederick J; Rivara, Frederick P; Ebel, Beth
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.
Morino, T; Ookawa, K; Haruta, N; Hagiwara, Y; Seki, M
To better understand the role of the professional oral health care for elderly in improving geriatric oral health, the effects of short-term professional oral health care (once per week for 1 month) on oral microbiological parameters were assessed. Parallel, open-labelled, randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka, Japan. Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention (17/34) and control (17/34) groups. The outcomes were changes in oral microbiological parameters (number of bacteria in unstimulated saliva; whole bacteria, Streptococcus, Fusobacterium and Prevotella: opportunistic pathogens detection: and index of oral hygiene evaluation [Dental Plaque Index, DPI]) within the intervention period. Each parameter was evaluated at before and after intervention period. Four elderly were lost from mortality (1), bone fracture (1), refused to participate (1) and multi-antibiotics usage (1). Finally, 30 elderly were analysed (14/intervention and 16/control). At baseline, no difference was found between the control and intervention groups. After the intervention period, the percentage of Streptococcus species increased significantly in the intervention group (Intervention, 86% [12/14]; Control, 50% [8/16]: Fisher's, right-tailed, P oral health care can improve oral conditions in the elderly. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Ge, Weiqing; Leson, Chelsea; Vukovic, Corey
[Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.
To compare abrupt and gradual smoking cessation. Randomized trial and observational study, Internet, 2007-2010. Smokers with no strong preference for abrupt or gradual quitting were randomly assigned to quitting immediately (n=472), or to gradually reducing their cigarette consumption over 2 weeks and then quit (n=502). Smokers who strongly preferred to quit abruptly were instructed to do so immediately (n=2456), those who strongly preferred gradual were instructed to reduce their cigarette consumption over 2 weeks, then quit (n=1801). Follow-up was conducted 4 weeks after target quit dates. Those who preferred abrupt quitting were the most motivated to quit and the most confident in their ability to quit. At follow-up, quit rates were 16% in those who preferred abrupt cessation, 7% in those who preferred gradual cessation and 9% in those who had no preference (pmotivation to quit and confidence in ability to quit: those who had low levels of motivation or low levels of confidence were more likely to quit at follow-up if they preferred and used abrupt rather than gradual. In those who had no strong preference for either method, abrupt and gradual produced similar results. Those who preferred and used the abrupt method were more likely to quit than those who preferred and used the gradual method, in particular when they had low motivation and confidence. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.
Hay, I C; Jamieson, M; Ormerod, A D
To investigate the efficacy of aromatherapy in the treatment of patients with alopecia areata. A randomized, double-blind, controlled trial of 7 months' duration, with follow-up at 3 and 7 months. Dermatology outpatient department. Eighty-six patients diagnosed as having alopecia areata. Eighty-six patients were randomized into 2 groups. The active group massaged essential oils (thyme, rosemary, lavender, and cedarwood) in a mixture of carrier oils (jojoba and grapeseed) into their scalp daily. The control group used only carrier oils for their massage, also daily. Treatment success was evaluated on sequential photographs by 2 dermatologists (I.C.H. and A.D.O.) independently. Similarly, the degree of improvement was measured by 2 methods: a 6-point scale and computerized analysis of traced areas of alopecia. Nineteen (44%) of 43 patients in the active group showed improvement compared with 6 (15%) of 41 patients in the control group (P = .008). An alopecia scale was applied by blinded observers on sequential photographs and was shown to be reproducible with good interobserver agreement (kappa = 0.84). The degree of improvement on photographic assessment was significant (P = .05). Demographic analysis showed that the 2 groups were well matched for prognostic factors. The results show aromatherapy to be a safe and effective treatment for alopecia areata. Treatment with these essential oils was significantly more effective than treatment with the carrier oil alone (P = .008 for the primary outcome measure). We also successfully applied an evidence-based method to an alternative therapy.
Kathryn S. Merriam
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.
Milano, W; Siano, C; Putrella, C; Capasso, A
Bulimia nervosa (BN) is one of the most common eating disorders in industrialized societies. It has been suggested that reduced serotonin activity triggers some of the cognitive and mood disturbances associated with BN. For this reason, the pharmacologic treatment of BN consists mainly of selective serotonin reuptake inhibitors (SSRIs), which have been proven effective. At present, the physiologic bases of this disorder are not yet completely understood. We conducted a randomized controlled trial to verify the efficacy of the SSRI fluvoxamine in patients with a diagnosis of BN. Twelve female outpatients aged 21 to 34 years with a diagnosis of BN-binge purging (as defined by the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders [DSM IV]) were randomly assigned to 2 treatment groups: the fluvoxamine 200 mg/day group and the placebo group. The patients underwent weekly clinical assessments for 12 weeks. At the end of the observation period, there was a statistically significant reduction in the number of binge-eating crises and purging episodes in the fluvoxamine group compared with placebo. In no case was treatment interrupted because of emergent side effects. These findings support the hypothesis that fluvoxamine is well tolerated and effective in reducing binge-eating crises and purging episodes in patients with BN.
Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre
A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days -14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). The 38 persons who completed the study (age 13-22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.
Cousineau, Tara M.; Green, Traci C.; Corsini, Evelyn; Seibring, A; Showstack, Marianne T.; Applegarth, Linda; Davidson, Marie; Perloe, Mark
BACKGROUND The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients. METHODS A randomized-controlled trial was conducted. Using a Solomon-four group design, 190 female patients were recruited from three US fertility centers and were randomized into two experimental and two no-treatment control groups. The psychological outcomes assessed included infertility distress, infertility self-efficacy, decisional conflict, marital cohesion and coping style. Program dosage and satisfaction were also assessed at four weeks follow-up. RESULTS Women exposed to the online program significantly improved in the area of social concerns (P = 0.038) related to infertility distress, and felt more informed about a medical decision with which they were contending (P = 0.037). Trends were observed for decreased global stress (P = 0.10), sexual concerns (P = 0.059), distress related to child-free living (P = 0.063), increased infertility self-efficacy (P = 0.067) and decision making clarity (P = 0.079). A dosage response was observed in the experimental groups for women who spent >60 min online for decreased global stress (P = 0.028) and increased self efficacy (P = 0.024). CONCLUSIONS This evidence-based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective resource for fertility practices. PMID:18089552
Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda
Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de
Full Text Available Abstract Background Arthroscopy is often used to treat patients with chronic patellofemoral pain syndrome (PFPS. As there is a lack of evidence, we conducted a randomized controlled trial to study the efficacy of arthroscopy in patients with chronic PFPS. Methods A total of 56 patients with chronic PFPS were randomized into two treatment groups: an arthroscopy group (N = 28, treated with knee arthroscopy and an 8-week home exercise program, and a control group (N = 28, treated with the 8-week home exercise program only. The arthroscopy included finding-specific surgical procedures according to current recommendations. The primary outcome was the Kujala score on patellofemoral pain and function at 9 months following randomization. Secondary outcomes were visual analog scales (VASs to assess activity-related symptoms. We also estimated the direct healthcare costs. Results Both groups showed marked improvement during the follow-up. The mean improvement in the Kujala score was 12.9 (95% confidence interval (CI 8.2–17.6 in the arthroscopy group and 11.4 (95% CI 6.9–15.8 in the control group. However, there was no difference between the groups in mean improvement in the Kujala score (group difference 1.1 (95% CI -7.4 - 5.2 or in any of the VAS scores. Total direct healthcare costs in the arthroscopy group were estimated to exceed on average those of the control group by €901 per patient (p Conclusion In this controlled trial involving patients with chronic PFPS, the outcome when arthroscopy was used in addition to a home exercise program was no better than when the home exercise program was used alone. Trial registration Current Controlled Trials ISRCTN 41800323
Sternfeld, Barbara; Guthrie, Katherine A; Ensrud, Kristine E; LaCroix, Andrea Z; Larson, Joseph C; Dunn, Andrea L; Anderson, Garnet L; Seguin, Rebecca A; Carpenter, Janet S; Newton, Katherine M; Reed, Susan D; Freeman, Ellen W; Cohen, Lee S; Joffe, Hadine; Roberts, Melanie; Caan, Bette J
This study aims to determine the efficacy of exercise training for alleviating vasomotor and other menopausal symptoms. Late perimenopausal and postmenopausal sedentary women with frequent vasomotor symptoms (VMS) participated in a randomized controlled trial conducted in three sites: 106 women randomized to exercise and 142 women randomized to usual activity. The exercise intervention consisted of individual facility-based aerobic exercise training three times per week for 12 weeks. VMS frequency and bother were recorded on daily diaries at baseline and on weeks 6 and 12. Intent-to-treat analyses compared between-group differences in changes in VMS frequency and bother, sleep symptoms (Insomnia Severity Index and Pittsburgh Sleep Quality Index), and mood (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7 questionnaire). At the end of week 12, changes in VMS frequency in the exercise group (mean change, -2.4 VMS/d; 95% CI, -3.0 to -1.7) and VMS bother (mean change on a four-point scale, -0.5; 95% CI, -0.6 to -0.4) were not significantly different from those in the control group (-2.6 VMS/d; 95% CI, -3.2 to -2.0; P = 0.43; -0.5 points; 95% CI, -0.6 to -0.4; P = 0.75). The exercise group reported greater improvement in insomnia symptoms (P = 0.03), subjective sleep quality (P = 0.01), and depressive symptoms (P = 0.04), but differences were small and not statistically significant when P values were adjusted for multiple comparisons. Results were similar when considering treatment-adherent women only. These findings provide strong evidence that 12 weeks of moderate-intensity aerobic exercise do not alleviate VMS but may result in small improvements in sleep quality, insomnia, and depression in midlife sedentary women.
Full Text Available BACKGROUND: Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. METHODS: Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC (n = 41 or standardized psychotherapy intervention (PT (n = 40 over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera (300 mg b.i.d. standardized to 1.5% with anolides, prepared from root. The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI and secondary outcome measures included the Short Form 36 (SF-36, Fatigue Symptom Inventory (FSI, and Measure Yourself Medical Outcomes Profile (MY-MOP to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. RESULTS: Seventy-five participants (93% were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001 in the NC group and 30.5% (p<0.0001 in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003. Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions
Block, Gladys; Azar, Kristen Mj; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H
In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or
Ball T Blake
Full Text Available Abstract Background The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART in Nairobi, Kenya. Methods and Design A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to receive either a structured weekly SMS ('short message system' or text message slogan (the intervention or current standard of care support mechanisms alone (the control. Our hypothesis is that using a structured mobile phone protocol to keep in touch with patients will improve adherence to ART and other patient outcomes. Participants are evaluated at baseline, and then at six and twelve months after initiating ART. The care providers keep a weekly study log of all phone based communications with study participants. Primary outcomes are self-reported adherence to ART and suppression of HIV viral load at twelve months scheduled follow-up. Secondary outcomes are improvements in health, quality of life, social and economic factors, and retention on ART. Primary analysis is by 'intention-to-treat'. Sensitivity analysis will be used to assess per-protocol effects. Analysis of covariates will be undertaken to determine factors that contribute or deter from expected and determined outcomes. Discussion This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting. Trial Registration Trial Registration Number: NCT00830622
Yue, Jirong; Zhang, Xuemei; Dong, Birong; Yang, Ming
Basic science data, animal studies, and observational human studies suggest that the lipid-lowering cardiovascular family of statin medications might decrease fractures, increase bone density, and have a positive effect on bone turnover markers. The primary purpose of our review was to determine whether statins can prevent fractures in postmenopausal women; as secondary and explanatory factors, bone density and bone biomarker data were also evaluated. All randomized controlled trials assessing the effect of statins on bone mineral density were included; bone turnover markers and fractures in postmenopausal women were considered. We identified six randomized trials involving 3,022 participants. Statins had no association with decreasing incidence of fracture. There was no statistical difference in the reduction in lumbar spine or total hip bone density. Other predictors of osteoporosis-related fracture risk, including markers relating to bone resorption (c-telopeptide of type I collagen and n-telopeptide of type I collagen) and bone formation (osteocalcin and bone-specific alkaline phosphates), did not show any significant changes. The trials included in our review, which included data on 3,022 women (mean age, >62.7 y), do not indicate that statin use prevents fractures or increases bone density.
Kong, Angela; Buscemi, Joanna; Stolley, Melinda R.; Schiffer, Linda A.; Kim, Yoonsang; Braunschweig, Carol L.; Gomez-Perez, Sandra L.; Blumstein, Lara B.; Van Horn, Linda; Dyer, Alan R.; Fitzgibbon, Marian L.
Introduction The preschool years provide a unique window of opportunity to intervene on obesity-related lifestyle risk factors during the formative years of a child’s life. The purpose of this study was to assess the impact of a preschool-based obesity prevention effectiveness trial at 1-year follow-up. Design RCT. Settings/participants Primarily African American children (aged 3–5 years, N=618) attending Head Start preschool programs administered by Chicago Public Schools. Methods Eighteen preschools were randomly assigned in 2007–2008 to receive either: (1) a 14-week teacher-delivered intervention focused on healthy lifestyle behaviors; or (2) a 14-week teacher-delivered general health curriculum (control group). Main outcome measures The primary outcome, BMI, was measured at baseline, post-intervention, and 1-year follow-up. Diet and screen time behaviors were also assessed at these time points. Multilevel mixed effects models were used to test for between-group differences. Data were analyzed in 2014. Results Significant between-group differences were observed in diet, but not in BMI z-score or screen time at 1-year follow-up. Diet differences favored the intervention arm over controls in overall diet quality (p=0.02) and in subcomponents of diet quality, as measured by the Healthy Eating Index-2005, and in fruit intake (servings/day, excludes juice) (p=0.02). Diet quality worsened more among controls than the intervention group at 1-year follow-up. Conclusions The adaptation of Hip-Hop to Health Jr. produced modest benefits in diet quality, but did not significantly impact weight gain trajectory. Not unlike other effectiveness trials, this real-world version delivered by Head Start teachers produced fewer benefits than the more rigorous efficacy trial. It is important to understand and build upon the lessons learned from these types of trials so that we can design, implement, and disseminate successful evidence-based programs more widely and effectively
Wade, Tracey D; Johnson, Catherine; Byrne, Susan M
While randomized controlled trials (RCTs) inform the efficacy and effectiveness of treatments, we need to understand that even RCTs can be associated with sub-optimal execution. This is of special pertinence to eating disorders given the majority of treatment studies involving cognitive behaviour therapy are of poor quality with respect to managing risk of bias adequately. The current paper outlines the components of a good RCT for psychotherapy, and examines ways to improve the conduct, interpretation, and usefulness of RCTs. This includes managing reporting bias, recognizing the limits of randomization, applicability, and ethical considerations. We highlight a number of strategies for future research, including issues related to utilizing a variety of designs to examine treatment outcomes, integrity, openness and reproducibility. © 2018 Wiley Periodicals, Inc.
Scherer, Roberta W; Drye, Lea; Mintzer, Jacobo; Lanctôt, Krista; Rosenberg, Paul; Herrmann, Nathan; Padala, Prasad; Brawman-Mintzer, Olga; Burke, William; Craft, Suzanne; Lerner, Alan J; Levey, Allan; Porsteinsson, Anton; van Dyck, Christopher H
Alzheimer's disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events. However, the trial only enrolled 60 participants who were followed for only 6 weeks. A larger, longer-lasting trial is required to confirm these promising findings. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a phase III, placebo-controlled, masked, 6-month, multi-center, randomized clinical trial targeted to enroll 200 participants with AD and apathy. Participants are randomly assigned 1:1 to 20 mg methylphenidate per day prepared as four over-encapsulated tablets or to matching placebo. The primary outcomes include (1) the mean difference in the Neuropsychiatric Inventory Apathy subscale scores measured as change from baseline to 6 months, and (2) the odds of having a given rating or better on the modified AD Cooperative Study Clinical Global Impression of Change ratings at month 6 compared with the baseline rating. Other outcomes include change in cognition, safety, and cost-effectiveness measured at monthly follow-up visits up to 6 months. Given the prevalence of apathy in AD and its impact on both patients and caregivers, an intervention to alleviate apathy would be of great benefit to society. ADMET 2 follows on the promising results from the original ADMET to evaluate the efficacy of methylphenidate as a
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.
Full Text Available BackgroundA 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.MethodsIn 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.ConclusionsPOCKET 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.
Duffett, Mark; Choong, Karen; Foster, Jennifer; Meade, Maureen; Menon, Kusum; Parker, Melissa; Cook, Deborah J
High-quality, adequately powered, randomized controlled trials are needed to inform the care of critically ill children. Unfortunately, such evidence is not always available. Our objective was to identify barriers and facilitators of conducting high-quality randomized controlled trials in pediatric critical care, from the perspective of trialists in this field. Self-administered online survey. Respondents rated the importance of barriers and effectiveness of facilitators on seven-point scales. Authors of 294 pediatric critical care randomized controlled trials (published 1986 to June 2015). One hundred sixteen researchers from 25 countries participated. None. Respondents reported a median (Q1, Q3) of 21 years (15, 26 yr) of experience and 41 (36%) had authored more than one randomized controlled trial. More survey respondents, compared with nonrespondents, had published more than one trial (35% vs 26%; p = 0.002) and their trials were more often cited (median citations/yr, 2.4 vs 1.5; p research, ability to recruit participants 24 hours per day/7 days per week, conducting randomized controlled trials in collaboration with a research network, funding from government agencies specifically for randomized controlled trials in critically ill children, and academic department support for conducting randomized controlled trials. Respondent experience and country income level were associated with differences in importance ratings for eight of 41 barriers. There were fewer such differences for facilitators. Lack of funding and time are major barriers to conducting pediatric critical care randomized controlled trials worldwide. Although barriers varied among country income levels, the facilitators of such trials were more consistent. In addition to increased funding, respondents identified other strategies such as research networks that are within the purview of the pediatric critical care research community, to facilitate the conduct of rigorous randomized controlled trials.
Al-Azri, Hilal; Ratnapalan, Savithiri
To investigate the effects of problem-based learning (PBL) in continuing medical education. PubMed, MEDLINE, EMBASE, CINAHL, and ERIC databases were searched for randomized controlled trials published in English from January 2001 to May 2011 using key words problem-based learning, practice-based, self-directed, learner-centered, and active learning, combined with continuing medical education, continuing professional development, post professional, postgraduate, and adult learning. Randomized controlled trials that described the effects of PBL on knowledge enhancement, performance improvement, participants' satisfaction, or patients' health outcomes were selected for analysis. Fifteen studies were included in this review: 4 involved postgraduate trainee doctors, 10 involved practising physicians, and 1 had both groups. Online learning was used in 7 studies. Among postgraduate trainees PBL showed no significant differences in knowledge gain compared with lectures or non-case-based learning. In continuing education, PBL showed no significant difference in knowledge gain when compared with other methods. Several studies did not provide an educational intervention for the control group. Physician performance improvement showed an upward trend in groups participating in PBL, but no significant differences were noted in health outcomes. Online PBL is a useful method of delivering continuing medical education. There is limited evidence that PBL in continuing education would enhance physicians' performance or improve health outcomes.
Neter, J.E.; Stam, B.E.; Kok, F.J.; Grobbee, D.E.; Geleijnse, J.M.
Increased body weight is a strong risk factor for hypertension. A meta-analysis of randomized controlled trials was performed to estimate the effect of weight reduction on blood pressure overall and in population subgroups. Twenty-five randomized, controlled trials (comprising 34 strata) published
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.
Thuesen, Leif; Jensen, Lisette Okkels; Tilsted, Hans Henrik
To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials.......To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials....
Lambers Heerspink, Hiddo J.; Knol, Mirjam J.; Tijssen, Robert J. W.; van Leeuwen, Thed N.; Grobbee, Diederick E.; de Zeeuw, Dick
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
Hagen, Åste M.; Melby-Lervåg, Monica; Lervåg, Arne
Background: Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. Methods: We conducted a cluster randomized trial in 148 preschool…
van den Bergh, Walter M.; Algra, A.; Dorhout Mees, S. M.; van Kooten, F.; Dirven, C. M. F.; van Gijn, J.; Vermeulen, M.; Rinkel, G. J. E.
BACKGROUND AND PURPOSE: A previous systematic review of randomized trials suggested a positive effect of antiplatelet therapy in patients with aneurysmal subarachnoid hemorrhage (SAH). We performed a randomized controlled trial to assess whether acetylsalicylic acid (ASA) reduces the risk of delayed
James-Burdumy, Susanne; Goesling, Brian; Deke, John; Einspruch, Eric
This article presents findings from the largest experimental evaluation to date of school-based mandatory-random student drug testing (MRSDT). The study tested the effectiveness of MRSDT in reducing substance use among high school students. Cluster randomized trial included 36 high schools and more than 4,700 9th through 12th grade students. After baseline data collection in spring 2007, about half the schools were randomly assigned to a treatment group that was permitted to implement MRSDT immediately, and the remaining half were assigned to a control group that delayed MRSDT until after follow-up data collection was completed 1 year later, in spring 2008. Data from self-administered student questionnaires were used to compare rates of substance use in treatment and control schools at follow-up. Students subject to MRSDT by their districts reported less substances use in past 30 days compared with students in schools without MRSDT. The program had no detectable spillover effects on the substance use of students not subject to testing. We found no evidence of unintentional negative effects on students' future intentions to use substances, the proportion of students who participated in activities subject to drug testing, or on students' attitudes toward school and perceived consequences of substance use. MRSDT shows promise in reducing illicit substance use among high school students. The impacts of this study were measured for a 1-year period and may not represent longer term effects. Copyright © 2012 Society for Adolescent Health and Medicine. All rights reserved.
Isaac, Clémence; Januel, Dominique
Cognitive impairments are a core feature in schizophrenia and are linked to poor social functioning. Numerous studies have shown that cognitive remediation can enhance cognitive and functional abilities in patients with this pathology. The underlying mechanism of these behavioral improvements seems to be related to structural and functional changes in the brain. However, studies on neural correlates of such enhancement remain scarce. We explored the neural correlates of cognitive enhancement following cognitive remediation interventions in schizophrenia and the differential effect between cognitive training and other therapeutic interventions or patients' usual care. We searched MEDLINE, PsycInfo, and ScienceDirect databases for studies on cognitive remediation therapy in schizophrenia that used neuroimaging techniques and a randomized design. Search terms included randomized controlled trial, cognitive remediation, cognitive training, rehabilitation, magnetic resonance imaging, positron emission tomography, electroencephalography, magnetoencephalography, near infrared spectroscopy, and diffusion tensor imaging. We selected randomized controlled trials that proposed multiple sessions of cognitive training to adult patients with a schizophrenia spectrum disorder and assessed its efficacy with imaging techniques. In total, 15 reports involving 19 studies were included in the systematic review. They involved a total of 455 adult patients, 271 of whom received cognitive remediation. Cognitive remediation therapy seems to provide a neurobiological enhancing effect in schizophrenia. After therapy, increased activations are observed in various brain regions mainly in frontal - especially prefrontal - and also in occipital and anterior cingulate regions during working memory and executive tasks. Several studies provide evidence of an improved functional connectivity after cognitive training, suggesting a neuroplastic effect of therapy through mechanisms of functional
Zheng, W; Xiang, Y-Q; Ng, C H; Ungvari, G S; Chiu, H F K; Xiang, Y-T
Free radicals may be involved in the pathogenesis of tardive dyskinesia (TD). We conducted this meta-analysis to systematically examine the efficacy of extract of Ginkgo biloba (EGb), a potent antioxidant possessing free radical-scavenging properties, as a treatment for TD in schizophrenia using randomized controlled trial (RCT) data. Drawn from English and Chinese databases, 3 RCTs of EGb augmentation of antipsychotics (APs) vs. AP plus placebo or AP monotherapy were identified. 2 evaluators extracted data. The primary outcome measure was the severity of TD symptoms assessed by the Abnormal Involuntary Movement Scale (AIMS). Weighted mean difference (WMD) and risk ratio (RR) ±95% confidence intervals (CI) were calculated. Statistical analyses were performed using Review Manager (version 126.96.36.199) and STATA (version 12.0). The 3 RCTs (n=299) from China, of 12 weeks duration, involved schizophrenia patients with TD of 55.9±13.4 years old. EGb (240 mg/day) outperformed the control group in reducing the severity of TD and clinical symptoms as measured by the AIMS (trials=3, n=299, WMD: -2.30 (95%CI: - 3.04, -1.55), P<0.00001) and the adverse drug reactions as assessed by the Treatment Emergent Symptom Scale (TESS) (trials=2, n=142, WMD: -2.38 (95%CI: -4.01, -0.74), P=0.004). Both the Positive and Negative Syndrome Scale (PANSS) total score (trials=2, n=239, P=0.87) and all-cause discontinuation (trials=3, n=299, P=0.21) were similar between the EGb and control group. This meta-analysis suggests that adjunctive EGb appeared to be an effective and safe option for improving TD in the treatment of schizophrenia patients. However, better RCTs are needed to demonstrate its efficacy and safety especially on cognitive function in TD. CRD42015024930. © Georg Thieme Verlag KG Stuttgart · New York.
Blencowe, Natalie S; Cook, Jonathan A; Pinkney, Thomas; Rogers, Chris; Reeves, Barnaby C; Blazeby, Jane M
Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.
Bagley, Heather J; Short, Hannah; Harman, Nicola L; Hickey, Helen R; Gamble, Carrol L; Woolfall, Kerry; Young, Bridget; Williamson, Paula R
Funders of research are increasingly requiring researchers to involve patients and the public in their research. Patient and public involvement (PPI) in research can potentially help researchers make sure that the design of their research is relevant, that it is participant friendly and ethically sound. Using and sharing PPI resources can benefit those involved in undertaking PPI, but existing PPI resources are not used consistently and this can lead to duplication of effort. This paper describes how we are developing a toolkit to support clinical trials teams in a clinical trials unit. The toolkit will provide a key 'off the shelf' resource to support trial teams with limited resources, in undertaking PPI. Key activities in further developing and maintaining the toolkit are to: ● listen to the views and experience of both research teams and patient and public contributors who use the tools; ● modify the tools based on our experience of using them; ● identify the need for future tools; ● update the toolkit based on any newly identified resources that come to light; ● raise awareness of the toolkit and ● work in collaboration with others to either develop or test out PPI resources in order to reduce duplication of work in PPI. Background Patient and public involvement (PPI) in research is increasingly a funder requirement due to the potential benefits in the design of relevant, participant friendly, ethically sound research. The use and sharing of resources can benefit PPI, but available resources are not consistently used leading to duplication of effort. This paper describes a developing toolkit to support clinical trials teams to undertake effective and meaningful PPI. Methods The first phase in developing the toolkit was to describe which PPI activities should be considered in the pathway of a clinical trial and at what stage these activities should take place. This pathway was informed through review of the type and timing of PPI activities within
Wilhelm, Sabine; Peterson, Alan L; Piacentini, John; Woods, Douglas W; Deckersbach, Thilo; Sukhodolsky, Denis G; Chang, Susanna; Liu, Haibei; Dziura, James; Walkup, John T; Scahill, Lawrence
Tics in Tourette syndrome begin in childhood, peak in early adolescence, and often decrease by early adulthood. However, some adult patients continue to have impairing tics. Medications for tics are often effective but can cause adverse effects. Behavior therapy may offer an alternative but has not been examined in a large-scale controlled trial in adults. To test the efficacy of a comprehensive behavioral intervention for tics in adults with Tourette syndrome of at least moderate severity. A randomized controlled trial with posttreatment evaluations at 3 and 6 months for positive responders. Three outpatient research clinics. Patients (N = 122; 78 males; age range, 16-69 years) with Tourette syndrome or chronic tic disorder were recruited between December 27, 2005, and May 21, 2009. Patients received 8 sessions of comprehensive behavioral intervention for tics or 8 sessions of supportive treatment for 10 weeks. Patients with a positive response were given 3 monthly booster sessions. Total tic score on the Yale Global Tic Severity Scale and the Clinical Global Impression-Improvement scale rated by a clinician masked to treatment assignment. Behavior therapy was associated with a significantly greater mean (SD) decrease on the Yale Global Tic Severity Scale (24.0 [6.47] to 17.8 [7.32]) from baseline to end point compared with the control treatment (21.8 [6.59] to 19.3 [7.40]) (P < .001; effect size = 0.57). Twenty-four of 63 patients (38.1%) were rated as much improved or very much improved on the Clinical Global Impression-Improvement scale compared with 4 of 63 (6.4%) in the control group (P < .001). Attrition was 13.9%, with no difference across groups. Patients receiving behavior therapy who were available for assessment at 6 months after treatment showed continued benefit. Comprehensive behavior therapy is a safe and effective intervention for adults with Tourette syndrome. clinicaltrials.gov Identifier: NCT00231985.
Morris, Jill K; Vidoni, Eric D; Johnson, David K; Van Sciver, Angela; Mahnken, Jonathan D; Honea, Robyn A; Wilkins, Heather M; Brooks, William M; Billinger, Sandra A; Swerdlow, Russell H; Burns, Jeffrey M
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. 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. 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. ClinicalTrials.gov NCT01128361.
Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco
Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (Pselective mutism, even if further studies are needed. The present study identifies in psychomotricity a safe and efficacy therapy for pediatric selective mutism.
O'Carroll, Ronan E; Shepherd, Lee; Hayes, Peter C; Ferguson, Eamonn
To test whether simply asking people to rate the extent to which they anticipate feeling regret for not registering as an organ donor after death increases subsequent verified organ donor registration. There were 14,509 members of the general public (both registered and nonregistered donors) randomly allocated to 1 of 4 arms, each receiving different questionnaires. The no-questionnaire control (NQC) arm received a survey measuring demographics and whether or not they were registered organ donors. The questionnaire control (QC) arm completed the NQC questions plus questions regarding affective attitudes and intention to register as an organ donor. The theory of planned behavior (TPB) questionnaire arm received the QC questionnaire, plus additional items measuring TPB variables. The anticipated regret (AR) arm received the TPB questionnaire, plus 2 additional items measuring anticipated regret. The main outcome measures were number of nondonor participants who subsequently registered 6 months later, as verified by the United Kingdom national transplant register. Intention-to-treat (ITT) analysis in nonregistered donors (N = 9,139) revealed the NQC arm were more likely to register as an organ donor (6.39%) compared with the AR (4.51%) arm. A brief anticipated regret intervention led to a decrease in registration. A potential reason is discussed in terms of questionnaire item content "priming" negative perceptions of organ donation. This is a methodological concern that needs to be addressed in studies that use similar interventions. Current controlled trials: www.controlled-trials.com number: ISRCTN922048897. (PsycINFO Database Record (c) 2016 APA, all rights reserved).
Edinger, Jack D; Wohlgemuth, William K; Krystal, Andrew D; Rice, John R
Insomnia is common and debilitating to fibromyalgia (FM) patients. Cognitive-behavioral therapy (CBT) is effective for many types of patients with insomnia, but has yet to be tested with FM patients. This study compared CBT with an alternate behavioral therapy and usual care for improving sleep and other FM symptoms. This randomized clinical trial enrolled 47 FM patients with chronic insomnia complaints. The study compared CBT, sleep hygiene (SH) instructions, and usual FM care alone. Outcome measures were subjective (sleep logs) and objective (actigraphy) total sleep time, sleep efficiency, total wake time, sleep latency, wake time after sleep onset, and questionnaire measures of global insomnia symptoms, pain, mood, and quality of life. Forty-two patients completed baseline and continued into treatment. Sleep logs showed CBT-treated patients achieved nearly a 50% reduction in their nocturnal wake time by study completion, whereas SH therapy- and usual care-treated patients achieved only 20% and 3.5% reductions on this measure, respectively. In addition, 8 (57%) of 14 CBT recipients met strict subjective sleep improvement criteria by the end of treatment compared with 2 (17%) of 12 SH therapy recipients and 0% of the usual care group. Comparable findings were noted for similar actigraphic improvement criteria. The SH therapy patients showed favorable outcomes on measures of pain and mental well-being. This finding was most notable in an SH therapy subgroup that self-elected to implement selected CBT strategies. Cognitive-behavioral therapy represents a promising intervention for sleep disturbance in FM patients. Larger clinical trials of this intervention with FM patients seem warranted.
Öhman, Hannareeta; Savikko, Niina; Strandberg, Timo E; Kautiainen, Hannu; Raivio, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo; Pitkälä, Kaisu H
To examine whether a regular, long-term exercise program performed by individuals with Alzheimer's disease (AD) at home or as group-based exercise at an adult daycare center has beneficial effects on cognition; to examine secondary outcomes of a trial that has been published earlier. Randomized, controlled trial. Community. Community-dwelling dyads (N = 210) of individuals with AD and their spousal caregivers randomized into three groups. Two types of intervention comprising customized home-based exercise (HE) and group-based exercise (GE), each twice a week for 1 year, were compared with a control group (CG) receiving usual community care. Cognitive function was measured using the Clock Drawing Test (CDT), Verbal Fluency (VF), Clinical Dementia Rating (CDR), and Mini-Mental State Examination (MMSE) at baseline and 3, 6, and 12 months of follow-up. Executive function, measured using CDT, improved in the HE group, and changes in the score were significantly better than those of the CG at 12 months (adjusted for age, sex, and CDR, P = .03). All groups deteriorated in VF and MMSE score during the intervention, and no significant differences between the groups were detected at 12-month follow-up when analyses were adjusted for age, sex, and CDR. Regular, long-term, customized HE improved the executive function of community-dwelling older people with memory disorders, but the effects were mild and were not observed in other domains of cognition. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.
Postuma, Ronald B; Lang, Anthony E; Munhoz, Renato P; Charland, Katia; Pelletier, Amelie; Moscovich, Mariana; Filla, Luciane; Zanatta, Debora; Rios Romenets, Silvia; Altman, Robert; Chuang, Rosa; Shah, Binit
Epidemiologic studies consistently link caffeine, a nonselective adenosine antagonist, to lower risk of Parkinson disease (PD). However, the symptomatic effects of caffeine in PD have not been adequately evaluated. We conducted a 6-week randomized controlled trial of caffeine in PD to assess effects upon daytime somnolence, motor severity, and other nonmotor features. Patients with PD with daytime somnolence (Epworth >10) were given caffeine 100 mg twice daily ×3 weeks, then 200 mg twice daily ×3 weeks, or matching placebo. The primary outcome was the Epworth Sleepiness Scale score. Secondary outcomes included motor severity, sleep markers, fatigue, depression, and quality of life. Effects of caffeine were analyzed with Bayesian hierarchical models, adjusting for study site, baseline scores, age, and sex. Of 61 patients, 31 were randomized to placebo and 30 to caffeine. On the primary intention-to-treat analysis, caffeine resulted in a nonsignificant reduction in Epworth Sleepiness Scale score (-1.71 points; 95% confidence interval [CI] -3.57, 0.13). However, somnolence improved on the Clinical Global Impression of Change (+0.64; 0.16, 1.13, intention-to-treat), with significant reduction in Epworth Sleepiness Scale score on per-protocol analysis (-1.97; -3.87, -0.05). Caffeine reduced the total Unified Parkinson's Disease Rating Scale score (-4.69 points; -7.7, -1.6) and the objective motor component (-3.15 points; -5.50, -0.83). Other than modest improvement in global health measures, there were no changes in quality of life, depression, or sleep quality. Adverse events were comparable in caffeine and placebo groups. Caffeine provided only equivocal borderline improvement in excessive somnolence in PD, but improved objective motor measures. These potential motor benefits suggest that a larger long-term trial of caffeine is warranted. This study provides Class I evidence that caffeine, up to 200 mg BID for 6 weeks, had no significant benefit on excessive daytime
Humiston, Sharon G; Schaffer, Stanley J; Szilagyi, Peter G; Long, Christine E; Chappel, Tahleah R; Blumkin, Aaron K; Szydlowski, Jill; Kolasa, Maureen S
Influenza vaccination coverage for U.S. school-aged children is below the 80% national goal. Primary care practices may not have the capacity to vaccinate all children during influenza vaccination season. No real-world models of school-located seasonal influenza (SLV-I) programs have been tested. Determine the feasibility, sustainability, and impact of an SLV-I program providing influenza vaccination to elementary school children during the school day. In this pragmatic randomized controlled trial of SLV-I during two vaccination seasons, schools were randomly assigned to SLV-I versus standard of care. Seasonal influenza vaccine receipt, as recorded in the state immunization information system (IIS), was measured. Intervention and control schools were located in a single western New York county. Participation (intervention or control) included the sole urban school district and suburban districts (five in Year 1, four in Year 2). After gathering parental consent and insurance information, live attenuated and inactivated seasonal influenza vaccines were offered in elementary schools during the school day. Data on receipt of ≥1 seasonal influenza vaccination in Year 1 (2009-2010) and Year 2 (2010-2011) were collected on all student grades K through 5 at intervention and control schools from the IIS in the Spring of 2010 and 2011, respectively. Additionally, coverage achieved through SLV-I was compared to coverage of children vaccinated elsewhere. Preliminary data analysis for Year 1 occurred in Spring 2010; final quantitative analysis for both years was completed in late Fall 2012. Results are shown for 2009-2010 and 2010-2011, respectively: Children enrolled in suburban SLV-I versus control schools had vaccination coverage of 47% vs 36%, and 52% vs 36% (pschool, school district) during both vaccination seasons, children were more likely to be vaccinated in SLV-I versus control schools; ORs were 1.6 (95% CI=1.4, 1.9; pvaccine during school is a promising approach to
Goldman, L Elizabeth; Sarkar, Urmimala; Kessell, Eric; Guzman, David; Schneidermann, Michelle; Pierluissi, Edgar; Walter, Barbara; Vittinghoff, Eric; Critchfield, Jeff; Kushel, Margot
Hospitals are implementing discharge support programs to reduce readmissions, and these programs have had mixed success. To examine whether a peridischarge, nurse-led intervention decreased emergency department (ED) visits or readmissions among ethnically and linguistically diverse older patients admitted to a safety-net hospital. Randomized, controlled trial using computer-generated randomization with 1:1 allocation, stratified by language. (Clinical Trials.gov: NCT01221532). Publicly funded urban hospital in Northern California. Hospitalized adults aged 55 years or older with anticipated discharge to the community who spoke English, Spanish, or Chinese (Mandarin or Cantonese). Usual care versus in-hospital, one-on-one, self-management education given by a dedicated language-concordant registered nurse combined with a telephone follow-up after discharge from a nurse practitioner. Staff blinded to the study groups determined ED visits or readmissions to any facility at 30, 90, and 180 days after initial hospital discharge using administrative data from several hospitals. There were 700 low-income, ethnically and linguistically diverse patients with a mean age of 66.2 years (SD, 9.0). The primary outcome of ED visits or readmissions did not differ between the intervention and usual care groups (hazard ratio, 1.26 [95% CI, 0.89 to 1.78] at 30 days, 1.21 [CI, 0.91 to 1.62] at 90 days, and 1.11 [CI, 0.86 to 1.43] at 180 days). This study was done at a single acute-care hospital. There were fewer outcomes than expected, which may have caused the study to be underpowered. A nurse-led, in-hospital discharge support intervention did not show a reduction in readmissions or ED visits among diverse, low-income older adults at a safety-net hospital. Although wide CIs preclude firm conclusions, the intervention may have increased ED visits. Alternative readmission prevention strategies should be tested in this population. Gordon and Betty Moore Foundation.
Ware, Mark A; Wang, Tongtong; Shapiro, Stan; Robinson, Ann; Ducruet, Thierry; Huynh, Thao; Gamsa, Ann; Bennett, Gary J; Collet, Jean-Paul
Chronic neuropathic pain affects 1%-2% of the adult population and is often refractory to standard pharmacologic treatment. Patients with chronic pain have reported using smoked cannabis to relieve pain, improve sleep and improve mood. Adults with post-traumatic or postsurgical neuropathic pain were randomly assigned to receive cannabis at four potencies (0%, 2.5%, 6% and 9.4% tetrahydrocannabinol) over four 14-day periods in a crossover trial. Participants inhaled a single 25-mg dose through a pipe three times daily for the first five days in each cycle, followed by a nine-day washout period. Daily average pain intensity was measured using an 11-point numeric rating scale. We recorded effects on mood, sleep and quality of life, as well as adverse events. We recruited 23 participants (mean age 45.4 [standard deviation 12.3] years, 12 women [52%]), of whom 21 completed the trial. The average daily pain intensity, measured on the 11-point numeric rating scale, was lower on the prespecified primary contrast of 9.4% v. 0% tetrahydrocannabinol (5.4 v. 6.1, respectively; difference = 0.7, 95% confidence interval [CI] 0.02-1.4). Preparations with intermediate potency yielded intermediate but nonsignificant degrees of relief. Participants receiving 9.4% tetrahydrocannabinol reported improved ability to fall asleep (easier, p = 0.001; faster, p sleep (less wakefulness, p = 0.01) relative to 0% tetrahydrocannabinol. We found no differences in mood or quality of life. The most common drug-related adverse events during the period when participants received 9.4% tetrahydrocannabinol were headache, dry eyes, burning sensation in areas of neuropathic pain, dizziness, numbness and cough. A single inhalation of 25 mg of 9.4% tetrahydrocannabinol herbal cannabis three times daily for five days reduced the intensity of pain, improved sleep and was well tolerated. Further long-term safety and efficacy studies are indicated. (International Standard Randomised Controlled Trial Register
Lynch, Mary; Sawynok, Jana; Hiew, Chok; Marcon, Dana
Fibromyalgia is difficult to treat and requires the use of multiple approaches. This study is a randomized controlled trial of qigong compared with a wait-list control group in fibromyalgia. One hundred participants were randomly assigned to immediate or delayed practice groups, with the delayed group receiving training at the end of the control period. Qigong training (level 1 Chaoyi Fanhuan Qigong, CFQ), given over three half-days, was followed by weekly review/practice sessions for eight weeks; participants were also asked to practice at home for 45 to 60 minutes per day for this interval. Outcomes were pain, impact, sleep, physical function and mental function, and these were recorded at baseline, eight weeks, four months and six months. Immediate and delayed practice groups were analyzed individually compared to the control group, and as a combination group. In both the immediate and delayed treatment groups, CFQ demonstrated significant improvements in pain, impact, sleep, physical function and mental function when compared to the wait-list/usual care control group at eight weeks, with benefits extending beyond this time. Analysis of combined data indicated significant changes for all measures at all times for six months, with only one exception. Post-hoc analysis based on self-reported practice times indicated greater benefit with the per protocol group compared to minimal practice. This study demonstrates that CFQ, a particular form of qigong, provides long-term benefits in several core domains in fibromyalgia. CFQ may be a useful adjuvant self-care treatment for fibromyalgia. clinicaltrials.gov NCT00938834.
Ong, Jason C; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K
To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Three-arm, single-site, randomized controlled trial. Academic medical center. Fifty-four adults with chronic insomnia. Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781. © 2014 Associated Professional Sleep Societies, LLC.
Laborie, Sophie; Denis, Angélique; Dassieu, Gilles; Bedu, Antoine; Tourneux, Pierre; Pinquier, Didier; Kermorvant, Elsa; Millet, Véronique; Klosowski, Serge; Patural, Hugues; Clamadieu, Catherine; Brunhes, Anne; Walther, Marie; Jaisson-Hot, Isabelle; Mandy, Bruno; Claris, Olivier
Oxidant stress is implicated in the pathogenesis of bronchopulmonary dysplasia (BPD). Light induces peroxide generation in parenteral nutrition (PN) solutions, creating an oxidant stress. Shielding PN from light decreases its peroxide content, which has nutrition and biochemical benefits in animals and humans. This study aims at determining whether full light protection of PN decreases the rate of bronchopulmonary dysplasia and/or death in very low-birth-weight infants. Multicenter randomized controlled trial of photoprotection, using amber bags and tubing initiated during compounding of PN and maintained throughout infusion in the light-protected (LP) group. The control group (light exposed [LE]) received PN exposed to ambient light. Depending on centers, lipids were infused either separately or as all-in-one PN. In total, 590 infants born <30 weeks gestational age were included. At randomization, LE and LP groups did not differ clinically except for maximal FiO2 before 12 hours. The rate of BPD/death was not different between groups at 28 days (77% LP vs 72% LE, P = .16) or at 36 weeks corrected age (30% LP vs 27% LE, P = .55). Multivariate analysis showed no significant effect of photoprotection on BPD and/or death. The rate of BPD/death was significantly lower (odds ratio, 0.54; 95% confidence interval, 0.32-0.93; P = .02) in infants receiving all-in-one PN vs those who received lipids separately. This study did not show significant beneficial effects of photoprotection. Since the decreased rate of BPD/death found with all-in-one PN relates to a center-dependent variable, this warrants further investigation. © 2014 American Society for Parenteral and Enteral Nutrition.
Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.
Clarebrough, E; Guest, G; Stupart, D
Anecdotally, many ostomates believe that eating marshmallows can reduce ileostomy effluent. There is a plausible mechanism for this, as the gelatine contained in marshmallows may thicken small bowel fluid, but there is currently no evidence that this is effective. This was a randomized crossover trial. Adult patients with well-established ileostomies were included. Ileostomy output was measured for 1 week during which three marshmallows were consumed three times daily, and for one control week where marshmallows were not eaten. There was a 2-day washout period. Patients were randomly allocated to whether the control or intervention week occurred first. In addition, a questionnaire was administered regarding patient's subjective experience of their ileostomy function. Thirty-one participants were recruited; 28 completed the study. There was a median reduction in ileostomy output volume of 75 ml per day during the study period (P = 0.0054, 95% confidence interval 23.4-678.3) compared with the control week. Twenty of 28 subjects (71%) experienced a reduction in their ileostomy output, two had no change and six reported an increase. During the study period, participants reported fewer ileostomy bag changes (median five per day vs six in the control period, P = 0.0255). Twenty of 28 (71%) reported that the ileostomy effluent was thicker during the study week (P = 0.023). Overall 19 (68%) participants stated they would use marshmallows in the future if they wanted to reduce or thicken their ileostomy output. Eating marshmallows leads to a small but statistically significant reduction in ileostomy output. Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.
Hunt, Ronald; Dienemann, Jacqueline; Norton, H James; Hartley, Wendy; Hudgens, Amanda; Stern, Thomas; Divine, George
Postoperative nausea (PON) is a common complication of anesthesia and surgery. Antiemetic medication for higher-risk patients may reduce but does not reliably prevent PON. We examined aromatherapy as a treatment for patients experiencing PON after ambulatory surgery. Our primary hypothesis was that in comparison with inhaling a placebo, PON will be reduced significantly by aromatherapy with (1) essential oil of ginger, (2) a blend of essential oils of ginger, spearmint, peppermint, and cardamom, or (3) isopropyl alcohol. Our secondary hypothesis was that the effectiveness of aromatherapy will depend upon the agent used. A randomized trial of aromatherapy with patients who reported nausea in the postanesthesia care unit was conducted at one ambulatory surgical center. Eligibility criteria were adult, able to give consent, and no history of coagulation problems or allergy to the aromatherapy agents. Before surgery, demographic and risk factors were collected. Patients with a nausea level of 1 to 3 on a verbal descriptive scale (0-3) received a gauze pad saturated with a randomly chosen aromatherapy agent and were told to inhale deeply 3 times; nausea (0-3) was then measured again in 5 minutes. Prophylactic and postnausea antiemetics were given as ordered by physicians or as requested by the patient. A total of 1151 subjects were screened for inclusion; 303 subjects reporting nausea were enrolled (26.3%), and 301 meeting protocol were analyzed (26.2%). The change in nausea level was significant for the blend (P aromatherapy was also significantly reduced with ginger or blend aromatherapy versus saline (P = 0.002 and P aromatherapy would be effective as a treatment for PON was supported. On the basis of our results, future research further evaluating aromatherapy is warranted. Aromatherapy is promising as an inexpensive, noninvasive treatment for PON that can be administered and controlled by patients as needed.
Naderinabi, Bahram; Soltanipour, Soheil; Nemati, Shadman; Saberi, Alia; Parastesh, Sepideh
There is challenge to find an effective treatment for tinnitus. Few studies were done on the effects of acupuncture on tinnitus. This study evaluated the effect of acupuncture on chronic non-pulsatile tinnitus. This randomized double-blind clinical trial was conducted from December 2014 to September 2015 . Patients suffering from chronic non-pulsatile tinnitus were randomly allocated into two groups: acupuncture vs. placebo. They were treated in 15 sessions and at the end of the fifteenth sessions and 3 weeks after completion of the treatment, visual analog scale (VAS) for tinnitus loudness and tinnitus severity index (TSI) questionnaires were completed. The case group included 26 males and 18 females, and in the control group there were 27 males and 17 females: with mean age of 49.11±1.07 and 55.20±8.33 years, respectively (p=0.005). TSI and VAS before treatment were 43.84±2.81 and 9.56±0.43 in cases and 43.52±2.94 and 9.54±0.45 in controls, respectively. Both measures improved after 15 sessions in cases to 24.82±1.04 and 2.88±0.33, and to 33.16±1.24 and 7.86±0.23 in controls. The changes of TSI and VAS were significant in all groups (pTSI and VAS in acupuncture group were lower than placebo group in each session (pTSI in the tenth session (p=0.392). Acupuncture is effective in reducing the loudness and severity of tinnitus and can be a useful treatment for nonpulsatile chronic tinnitus.
Bhan, Ishir; Dobens, Dorothy; Tamez, Hector; Deferio, Joseph J; Li, Yan Chun; Warren, H Shaw; Ankers, Elizabeth; Wenger, Julia; Tucker, J Kevin; Trottier, Caitlin; Pathan, Fridosh; Kalim, Sahir; Nigwekar, Sagar U; Thadhani, Ravi
Vitamin D (25-hydroxyvitamin D; 25[OH]D) deficiency is common in patients initiating long-term hemodialysis, but the safety and efficacy of nutritional vitamin D supplementation in this population remain uncertain. This randomized, placebo-controlled, parallel-group multicenter trial compared two doses of ergocalciferol with placebo between October 2009 and March 2013. Hemodialysis patients (n=105) with 25(OH)D levels ≤32 ng/ml from 32 centers in the Northeast United States were randomly assigned to oral ergocalciferol, 50,000 IU weekly (n=36) or monthly (n=33), or placebo (n=36) for a 12-week treatment period. The primary endpoint was the achievement of vitamin D sufficiency (25[OH]D >32 ng/ml) at the end of the 12-week treatment period. Survival was assessed through 1 year. Baseline characteristics were similar across all arms, with overall mean±SD 25(OH)D levels of 21.9±6.9 ng/ml. At 12 weeks, vitamin D sufficiency (25[OH]D >32 ng/ml) was achieved in 91% (weekly), 66% (monthly), and 35% (placebo) (Pvitamin D treatment did not differ between groups. All-cause and cause-specific hospitalizations and adverse events were similar between groups during the intervention period. Lower all-cause mortality among ergocalciferol-treated participants was not statistically significant (hazard ratio, 0.28; 95% confidence interval, 0.07 to 1.19). Oral ergocalciferol can increase 25(OH)D levels in incident hemodialysis patients without significant alterations in blood calcium, phosphate, or parathyroid hormone during a 12-week period. Copyright © 2015 by the American Society of Nephrology.
Barthel, H Richard; Haselwood, Douglas; Longley, Selden; Gold, Morris S; Altman, Roy D
Nonsteroidal anti-inflammatory drugs have dose-related adverse effects. Topical nonsteroidal anti-inflammatory drugs may offer local efficacy with low systemic drug levels. This study assessed the efficacy and safety of topical diclofenac sodium 1% gel (DSG) in mild to moderate symptomatic knee osteoarthritis. In a randomized, double-blind, vehicle-controlled trial, 492 adults aged >or=35 years with symptomatic knee osteoarthritis of >or=6 months' duration were randomized to DSG 4 g (n = 254) or vehicle (n = 238) 4 times daily for 12 weeks. Primary efficacy outcomes at week 12 were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, WOMAC physical function subscale, and global rating of disease. Secondary outcomes included these outcomes assessed after 1, 4, and 8 weeks, and pain on movement assessed using a 100-mm visual analog scale. All adverse events were recorded. At week 12, the DSG group had significant decreases versus the vehicle group in mean WOMAC pain (P = 0.01), mean WOMAC physical function (P = 0.001), and mean global rating of disease (P < 0.001). Efficacy outcomes significantly favored DSG versus vehicle beginning at week 1. Application site reactions occurred in 5.1% and 2.5% of patients in the DSG and vehicle groups, respectively. The incidence of gastrointestinal disorders was 5.9% with DSG and 5.0% with vehicle. Over a 3-month treatment period, topical treatment with DSG achieved statistically and clinically significant improvements of pain and measures of physical function in patients with knee osteoarthritis.
Chen, Mei-Fang; Hung, Shu-Ling; Chen, Shu-Lin
Practicing a health-promoting lifestyle is believed to be effective for delaying or preventing the onset of diabetes. However, although empowerment interventions have proven effective for encouraging the adoption of a health-promoting lifestyle in people with diabetes, these interventions are rarely promoted to people with prediabetes. The aims of this study were to develop an empowerment program for people with prediabetes and to examine its efficacy in terms of the adoption of a health-promoting lifestyle and improvements in blood sugar, body mass index, and self-efficacy. A randomized controlled trial was conducted between May and December 2013. A convenience sample of people with a fasting blood sugar level of 100-125 mg/dl during the previous 3 months was recruited from the health examination center of a hospital in Kaohsiung, Taiwan. Participants were assigned to either the experimental group or the control group using block randomization with a block size of 8. The experimental group (n = 38) participated in a 4-month empowerment program (the ABC empowerment program), which encouraged participants to practice a health-promoting lifestyle in three phases: awareness raising, behavior building, and results checking. The control group (n = 40) received routine clinical care. Statistical analyses included descriptive statistics, independent t test, paired t test, and generalized estimated equations. After controlling for the differences at baseline and considering the interaction between group and time from baseline to 1 week and 3 months after completing the intervention, the generalized estimating equation showed significantly larger improvements in a health-promoting lifestyle, blood sugar, and self-efficacy in the experimental group than in the control group (p empowerment program was shown to have short-term, positive effects on behavioral, physical, and psychosocial outcomes in a Taiwan population with prediabetes. The results of this study provide a useful
Jonathan D. Eldredge
Chung Grace Y
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
Ieto, Vanessa; Kayamori, Fabiane; Montes, Maria I; Hirata, Raquel P; Gregório, Marcelo G; Alencar, Adriano M; Drager, Luciano F; Genta, Pedro R; Lorenzi-Filho, Geraldo
Snoring is extremely common in the general population and may indicate OSA. However, snoring is not objectively measured during polysomnography, and no standard treatment is available for primary snoring or when snoring is associated with mild forms of OSA. This study determined the effects of oropharyngeal exercises on snoring in minimally symptomatic patients with a primary complaint of snoring and diagnosis of primary snoring or mild to moderate OSA. Patients were randomized for 3 months of treatment with nasal dilator strips plus respiratory exercises (control) or daily oropharyngeal exercises (therapy). Patients were evaluated at study entry and end by sleep questionnaires (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index) and full polysomnography with objective measurements of snoring. We studied 39 patients (age, 46 ± 13 years; BMI, 28.2 ± 3.1 kg/m2; apnea-hypopnea index (AHI), 15.3 ± 9.3 events/h; Epworth Sleepiness Scale, 9.2 ± 4.9; Pittsburgh Sleep Quality Index, 6.4 ± 3.3). Control (n = 20) and therapy (n = 19) groups were similar at study entry. One patient from each group dropped out. Intention-to-treat analysis was used. No significant changes occurred in the control group. In contrast, patients randomized to therapy experienced a significant decrease in the snore index (snores > 36 dB/h), 99.5 (49.6-221.3) vs 48.2 (25.5-219.2); P = .017 and total snore index (total power of snore/h), 60.4 (21.8-220.6) vs 31.0 (10.1-146.5); P = .033. Oropharyngeal exercises are effective in reducing objectively measured snoring and are a possible treatment of a large population suffering from snoring. ClinicalTrials.gov; No.: NCT01636856; URL: www.clinicaltrials.gov.
Szilagyi, Peter G; Schaffer, Stanley; Rand, Cynthia M; Vincelli, Phyllis; Eagan, Ashley; Goldstein, Nicolas P N; Hightower, A Dirk; Younge, Mary; Blumkin, Aaron; Albertin, Christina S; Yoo, Byung-Kwang; Humiston, Sharon G
Assess impact of offering school-located influenza vaccination (SLIV) clinics using both Web-based and paper consent upon overall influenza vaccination rates among elementary school children. We conducted a cluster-randomized trial (stratified by suburban/urban districts) in upstate New York in 2014-2015. We randomized 44 elementary schools, selected similar pairs of schools within districts, and allocated schools to SLIV versus usual care (control). Parents of children at SLIV schools were sent information and vaccination consent forms via e-mail, backpack fliers, or both (depending on school preferences) regarding school vaccine clinics. Health department nurses conducted vaccine clinics and billed insurers. For all children registered at SLIV/control schools, we compared receipt of influenza vaccination anywhere (primary outcome). The 44 schools served 19 776 eligible children in 2014-2015. Children in SLIV schools had higher influenza vaccination rates than children in control schools county-wide (54.1% vs 47.4%, P vaccination in previous season) confirmed bivariate findings. Among parents who consented for SLIV, nearly half of those notified by backpack fliers and four-fifths of those notified by e-mail consented online. In suburban districts, SLIV did not substitute for primary care influenza vaccination. In urban schools, some substitution occurred. SLIV raised seasonal influenza vaccination rates county-wide and in both suburban and urban settings. SLIV did not substitute for primary care vaccinations in suburban settings where pediatricians often preorder influenza vaccine but did substitute somewhat in urban settings. Copyright © 2016 by the American Academy of Pediatrics.
Cejudo, Pilar; Bautista, Juan; Montemayor, Teodoro; Villagómez, Rafael; Jiménez, Luis; Ortega, Francisco; Campos, Yolanda; Sánchez, Hildegard; Arenas, Joaquín
Patients with mitochondrial myopathies (MM) usually suffer from exercise intolerance due to their impaired oxidative capacity and physical deconditioning. We evaluated the effects of a 12-week supervised randomized rehabilitation program involving endurance training in patients with MM. Twenty MM patients were assigned to a training or control group. For three nonconsecutive days each week, patients combined cycle exercise at 70% of their peak work rate with three upper-body weight-lifting exercises performed at 50% of maximum capacity. Training increased maximal oxygen uptake (28.5%), work output (15.5%), and minute ventilation (40%), endurance performance (62%), walking distance in shuttle walking test (+95 m), and peripheral muscle strength (32%-62%), and improved Nottingham Health Profile scores (21.47%) and clinical symptoms. Control MM patients did not change from baseline. Results show that our exercise program is an adequate training strategy for patients with mitochondrial myopathy.
Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne
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. (PsycINFO Database Record (c) 2014 APA, all rights reserved).
Gorter, Rosalie; Fox, Jean-Paul; Apeldoorn, Adri; Twisk, Jos
In randomized controlled trials (RCTs), outcome variables are often patient-reported outcomes measured with questionnaires. Ideally, all available item information is used for score construction, which requires an item response theory (IRT) measurement model. However, in practice, the classical test theory measurement model (sum scores) is mostly used, and differences between response patterns leading to the same sum score are ignored. The enhanced differentiation between scores with IRT enables more precise estimation of individual trajectories over time and group effects. The objective of this study was to show the advantages of using IRT scores instead of sum scores when analyzing RCTs. Two studies are presented, a real-life RCT, and a simulation study. Both IRT and sum scores are used to measure the construct and are subsequently used as outcomes for effect calculation. The bias in RCT results is conditional on the measurement model that was used to construct the scores. A bias in estimated trend of around one standard deviation was found when sum scores were used, where IRT showed negligible bias. Accurate statistical inferences are made from an RCT study when using IRT to estimate construct measurements. The use of sum scores leads to incorrect RCT results. Copyright Â© 2016 Elsevier Inc. All rights reserved.
Hammond, David; Goodman, Samantha; Hanning, Rhona; Daniel, Samantha
Food consumed outside the home accounts for a growing proportion of the North American diet and has been associated with increased obesity. To examine the effect of nutrition labeling on menus on awareness, use, and food consumption, including the impact of "traffic light" labeling and adding other nutrients. Blinded, randomized trial with 635 Canadian adults conducted in 2010-2011. Participants ordered a free meal from one of four experimental menus: 1) no nutritional information shown, 2) calorie amounts only, 3) calorie amounts in "traffic lights", and 4) calorie, fat, sodium, and sugar shown in "traffic lights". Recall of nutrition information, knowledge of calorie content and nutrient consumption were assessed. Participants in the calorie conditions were more likely to recall the calorie content of meals and to report using nutrition information when ordering. The calorie content of meals was not significantly different across conditions; however, calorie consumption was significantly lower among participants in the Calorie-only condition compared to the No information condition (mean=-96 kcal, p=.048). Menu labeling increased awareness and use of nutrition information and reduced consumption. Adding "traffic lights", fat, sodium, and sugar amounts to menus had little impact compared to calorie-only labeling. © 2013.
Tariq, N.; Basharat, A.; Fahim, A.
Objective: To compare the efficacy of multiple doses of vaginal clindamycin with a single oral dose of secnidazole for the treatment of bacterial vaginosis. Study Design: Double-blinded randomized controlled trial. Place and Duration of Study: Shifa Foundation Community Health Center, from March 2012 till February 2015. Methodology: After obtaining written informed consent, a pelvic examination was performed for the confirmation of symptoms of milky white vaginal discharge on speculum examination, positive Amine test and presence of clue cells on microscopy. Pregnant women, known diabetes or any immunocompromised condition, were excluded. Blinding of the patient, doctor, and the pharmacist was done. Study cohort was then divided into two groups, Group A received medicine pack A which contained active clindamycin and placebo oral preparation, whereas group B was given pack B which contained active 2-gm secnidazole with placebo vaginal cream. Primary outcome and therapeutic success were defined by correction of two out of three (normal Nugent score, negative Amine test, and no milky white discharge) on day 15. Results: At 15th day of treatment, 96.6% participants in vaginal clindamycin group (Group A), recovered from the bacterial vaginosis; whereas, (group B) 23% patients were cured in oral secnidazole group. Conclusion: Multiple doses of vaginal clindamycin are superior to single dose of oral secnidazole for the treatment of bacterial vaginosis. (author)
Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten; Kesmodel, Ulrik S; Hvidman, Lone
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. 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 assessed by a visual analogue scale, birth experience and satisfaction with delivery, and pain relief evaluated at 2 months postpartum. Secondary obstetric outcomes were duration of labor, use of oxytocin, mode of delivery, postpartum hemorrhage, Apgar score, and umbilical cord pH value. Analysis complied with the intention-to-treat principle. Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin. Mean Apgar score at 5 minutes and umbilical cord pH value were significantly higher among infants in the acupuncture group compared with infants in the other groups. Acupuncture reduced the need for pharmacological and invasive methods during delivery. Acupuncture is a good supplement to existing pain relief methods.
Kryscio, R J; Abner, E L; Schmitt, F A; Goodman, P J; Mendiondo, M; Caban-Holt, A; Dennis, B C; Mathews, M; Klein, E A; Crowley, J J
To summarize the ongoing prevention of Alzheimer's disease (AD) by vitamin E and selenium (PREADViSE) trial as an ancillary study to SELECT (a large prostate cancer prevention trial) and to present the blinded results of the first year as an exposure study. PREADViSE was designed as a double blind randomized controlled trial (RCT). SELECT terminated after median of 5.5 years of exposure to supplements due to a futility analysis. Both trials then converted into an exposure study. In the randomized component PREADViSE enrolled 7,547 men age 62 or older (60 if African American). Once the trial terminated 4,246 of these men volunteered for the exposure study. Demographics were similar for both groups with exposure volunteers having baseline mean age 67.3 ± 5.2 years, 15.3 ± 2.4 years of education, 9.8% African Americans, and 22.0% reporting a family history of dementia. In the RCT men were randomly assigned to either daily doses of 400 IU of vitamin E or placebo and 200 µg of selenium or placebo using a 2x2 factorial structure. In the RCT, participants completed the memory impairment screen (MIS), and if they failed, underwent a longer screening (based on an expanded Consortium to Establish a Registry in AD [CERAD] battery). CERAD failure resulted in visits to their clinician for medical examination with records of these examinations forwarded to the PREADViSE center for further review. In the exposure study, men are contacted by telephone and complete the telephone version of the memory impairment screen (MIS-T) screen. If they fail the MIS-T, a modified telephone interview of cognitive status (TICS-M) exam is given. A failed TICS-M exam also leads to a visit to their clinician for an in-depth examination and forwarding of records for a centralized consensus diagnosis by expert clinicians. A subgroup of the men who pass the MIS-T also take the TICS-M exam for validation purposes. While this ancillary trial was open to all 427 SELECT clinical sites, only 130 (30
Badawy, Haytham; Zoaier, Amr; Ghoneim, Tamer; Hanno, Ahmed
Laparoscopic pyeloplasty achieves good cosmetic and functional outcomes. Both transperitoneal and retroperitoneal approaches are used. No single study to date has compared the two approaches in a prospective randomized design. We present a prospective randomized comparison between both approaches in children in a trial to define which technique is better with regard to multiple factors including operative time, hospital stay, recovery of bowel movement, analgesic requirement and complication rate. In the period from June 2010 to September 2012, 38 children (25 boys and 13 girls) were operated laparoscopically. Children were randomized into Group I (19 children) operated by the transperitoneal approach, and Group II (19 children) operated by the retroperitoneal approach. Both groups were compared as regards to the operative time, anesthetic changes, and postoperative recovery. A minimum sample size required was calculated to be 19 for each arm based on previous studies of laparoscopic pyeloplasty, using a mean difference in operative time = 40 min, effect size = 0.95, an alpha of 0.05 and power 80% and an online sample size calculator. Statistical analysis was performed using SPSS software using the Fischer exact test, chi square test and Mann-Whitney U test. The operative time was the primary endpoint for comparison between both approaches. Our series is the first in the literature that compares in a prospective randomized design the transperitoneal and retroperitoneal laparoscopic pyeloplasty in children. Shouma et al. is the only prospective randomized study to compare both techniques in adult pyeloplasty. They had a significantly shorter operative time in the transperitoneal group however, the author in the discussion mentioned that he was at the start of the learning curve for retroperitonoscopic pyeloplasty when he conducted his study, which affected the result of the operative time. Hence, as mentioned above, we stressed the importance of a single surgeon
Cao, Huijuan; Zhu, Chenjun; Liu, Jianping
Wet cupping is a traditional Chinese medicine therapy commonly used in treating herpes zoster in China, and clinical studies have shown that wet cupping may have beneficial effect on herpes zoster compared with Western medication. We included randomized controlled trials (RCTs) on wet cupping for herpes zoster. We searched PubMed, the Cochrane Library (Issue 3, 2008), China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journals Fulltext Database VIP, and Wan Fang Database. All searches ended in February 2009. Two authors extracted data and assessed the trials' quality independently. RevMan 5.0.18 software (The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark) was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). Eight RCTs involving 651 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding, and intention-to-treat analysis. Meta-analyses showed wet cupping was superior to medication in the number of cured patients (RR 2.49, 95% CI 1.91 to 3.24, P cupping plus medication was significantly better than medication alone on number of cured patients (RR 1.93, 95% CI 1.23 to 3.04, P = .005) but demonstrated no difference in symptom improvement (RR 1.00, 95% CI 0.92 to 1.08, P = .98). There were no serious adverse effects related to wet cupping therapy in the included trials. Wet cupping appears to be effective in the treatment of herpes zoster. However, further large, rigorously designed
Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. Methods/Design The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. Discussion The results of the trial will be used to produce a maximally
Volpp, Kevin G; Troxel, Andrea B; Long, Judith A; Ibrahim, Said A; Appleby, Dina; Smith, J Otis; Jaskowiak, Jane; Helweg-Larsen, Marie; Doshi, Jalpa A; Kimmel, Stephen E
Efforts to improve adherence by reducing co-payments through value-based insurance design are become more prevalent despite limited evidence of improved health outcomes. The objective of this study was to determine whether eliminating patient co-payments for blood pressure medications improves blood pressure control. Randomized controlled trial. The Collaboration to Reduce Disparities in Hypertension (CHORD) was a randomized controlled trial with 12 months' follow-up conducted among patients from the Philadelphia and Pittsburgh Veterans Administration Medical Centers. We enrolled 479 patients with poorly controlled systolic blood pressure. Participants were randomly assigned to: a) receive reductions in co-payments from $8 to $0 per medication per month for each antihypertensive prescription filled, b) a computerized behavioral intervention (CBI), c) both co-pay reduction and CBI, or d) usual care. Our main outcome measure was change in systolic blood pressure from enrollment to 12 months post enrollment. We also measured adherence using the medication possession ratio in a subset of participants. There were no significant interactions between the co-payment interventions and the CBI interventions. There was no relative difference in the change in medication possession ratio between baseline and 12 months (0.05% and -.90% in control and incentive groups, respectively; P = .74) or in continuous medication gaps of 30, 60, or 90 days. Blood pressure decreased among all participants, but to a similar degree between the financial incentive and control groups. Systolic pressure within the incentive group dropped 13.2 mm Hg versus 15.2 mm Hg for the control group (difference = 2.0; 95% CI, -2.3 to 6.3; P = .36). The proportion of patients with blood pressure under control at 12 months was 29.5% in the incentive group versus 33.9 in the control group (odds ratio, 0.8; 95% CI, 0.5-1.3; P = .36). Among patients with poorly controlled blood pressure, financial incentives
IMPROVE trial: a randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies.
Dampier, Carlton D; Smith, Wally R; Wager, Carrie G; Kim, Hae-Young; Bell, Margaret C; Miller, Scott T; Weiner, Debra L; Minniti, Caterina P; Krishnamurti, Lakshmanan; Ataga, Kenneth I; Eckman, James R; Hsu, Lewis L; McClish, Donna; McKinlay, Sonja M; Molokie, Robert; Osunkwo, Ifeyinwa; Smith-Whitley, Kim; Telen, Marilyn J
sites likely slowed study initiation. More extensive involvement of research staff and site principal investigator in the clinical care operations improved site performance. During the subsequent data analysis, alternative statistical approaches were considered, the results of which should inform future efficacy assessments and increase future trial recruitment success by allowing substantial reductions in target sample size. A complex randomized analgesic trial was initiated within a multisite disease network seeking to provide an evidence base for clinical care. A number of design considerations were shown to be feasible in this setting, and several pain intensity and pain interference measures were shown to be sensitive to time- and treatment-related improvements. While the premature closure and small sample size precluded definitive conclusions regarding treatment efficacy, this trial furnishes a template for design and implementation considerations that should improve future SCD analgesic trials.
Gulliford, Martin C; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Charlton, Judith; Dregan, Alex
BACKGROUND: There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical
Anderson, Monique L; Califf, Robert M; Sugarman, Jeremy
Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings. © The Author(s) 2015.
Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise
The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated
Markus D. Jakobsen
Full Text Available Abstract Background While benefits of workplace physical exercise on physical health is well known, little is known about the psychosocial effects of such initiatives. This study evaluates the effect of workplace versus home-based physical exercise on psychosocial factors among healthcare workers. Methods A total of 200 female healthcare workers (Age: 42.0, BMI: 24.1 from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1 home-based physical exercise (HOME performed alone during leisure time for 10 min 5 days per week or 2 workplace physical exercise (WORK performed in groups during working hours for 10 min 5 days per week and up to 5 group-based coaching sessions on motivation for regular physical exercise. Vitality and mental health (SF-36, scale 0–100, psychosocial work environment (COPSOQ, scale 0–100, work- and leisure disability (DASH, 0–100, control- (Bournemouth, scale 0–10 and concern about pain (Pain Catastrophizing Scale, scale 0–10 were assessed at baseline and at 10-week follow-up. Results Vitality as well as control and concern about pain improved more following WORK than HOME (all p < 0.05 in spite of increased work pace (p < 0.05. Work- and leisure disability, emotional demands, influence at work, sense of community, social support and mental health remained unchanged. Between-group differences at follow-up (WORK vs. HOME were 7 [95% confidence interval (95% CI 3 to 10] for vitality, −0.8 [95% CI -1.3 to −0.3] for control of pain and −0.9 [95% CI -1.4 to −0.5] for concern about pain, respectively. Conclusions Performing physical exercise together with colleagues during working hours was more effective than home-based exercise in improving vitality and concern and control of pain among healthcare workers. These benefits occurred in spite of increased work pace. Trial registration NCT01921764 at ClinicalTrials.gov . Registered 10 August 2013.
-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
Ubbink Dirk T
Full Text Available Abstract Background Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds. Methods A 14-center, six-armed randomized clinical trial is being carried out in the Netherlands. An a-priori power analysis and an anticipated dropout rate of 15% indicates that 50 patients per group are necessary, totaling 300 patients, to be able to detect a 25% quicker mean time to complete wound healing. Randomization has been computerized to ensure allocation concealment. Adult patients who need a split-skin grafting operation for any reason, leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings: hydrocolloid, alginate, film, hydrofiber, silicone dressing, or paraffin gauze. No combinations of products from other intervention groups in this trial are allowed. Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers. Primary outcomes are days to complete wound healing and pain (using a Visual Analogue Scale. Secondary outcomes are adverse effects, scarring, patient satisfaction, and costs. Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred. Results will be analyzed according to the intention to treat principle. The first patient was randomized October 1, 2009. Discussion This study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such
Shanahan, William R; Rose, Jed E; Glicklich, Alan; Stubbe, Scott; Sanchez-Kam, Matilde
Lorcaserin is a selective serotonin 2C receptor agonist approved by the Food and Drug Administration for chronic weight management. Preclinical data suggest that it may also be effective in smoking cessation through modulation of the dopaminergic reward system. This was a 12-week, randomized, double-blind, placebo-controlled trial conducted in 30 centers in the United States. Six hundred three adult smokers with a Body Mass Index of 18.5-35 kg/m2, averaging at least 10 cigarettes/day with no period of abstinence >3 months for the past year were randomized to lorcaserin 10 mg once daily (QD), 10 mg twice daily (BID) or placebo; all received standardized smoking cessation counseling weekly. The target quit date was day 15. The primary endpoint was the exhaled carbon monoxide confirmed Continuous Abstinence Rate for weeks 9-12 (month 3). Continuous Abstinence Rates for month 3 were 5.6%, 8.7%, and 15.3% for the placebo, QD and BID groups, respectively (BID vs. placebo odds ratio 3.02, 95% confidence interval 1.47, 6.22, p = .0027. Change in weight at week 12 (randomized population) was -0.01, -0.35 and -0.98 kg, respectively (p = .0004, BID vs. placebo), and +0.73, +0.76, and -0.41 kg in participants achieving month 3 continuous abstinence. The most frequent adverse events were headache, nausea, constipation, and fatigue. Lorcaserin with counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain over a 3-month period. Further investigation of lorcaserin in smoking cessation is warranted. Trial Registration: ClinicalTrials.gov. Identifier: NCT02044874. This randomized, controlled trial demonstrated that lorcaserin used in conjunction with standard cessation counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain. To our knowledge, this is the first demonstration in humans of a potential role of 5-HT2C agonism in the modulation of central neurological
De Stefano, Carla; Normand, Domitille; Jabre, Patricia; Azoulay, Elie; Kentish-Barnes, Nancy; Lapostolle, Frederic; Baubet, Thierry; Reuter, Paul-Georges; Javaud, Nicolas; Borron, Stephen W; Vicaut, Eric; Adnet, Frederic
The themes of qualitative assessments that characterize the experience of family members offered the choice of observing cardiopulmonary resuscitation (CPR) of a loved one have not been formally identified. In the context of a multicenter randomized clinical trial offering family members the choice of observing CPR of a patient with sudden cardiac arrest, a qualitative analysis, with a sequential explanatory design, was conducted. The aim of the study was to understand family members' experience during CPR. All participants were interviewed by phone at home three months after cardiac arrest. Saturation was reached after analysis of 30 interviews of a randomly selected sample of 75 family members included in the trial. Four themes were identified: 1- choosing to be actively involved in the resuscitation; 2- communication between the relative and the emergency care team; 3- perception of the reality of the death, promoting acceptance of the loss; 4- experience and reactions of the relatives who did or did not witness the CPR, describing their feelings. Twelve sub-themes further defining these four themes were identified. Transferability of our findings should take into account the country-specific medical system. Family presence can help to ameliorate the pain of the death, through the feeling of having helped to support the patient during the passage from life to death and of having participated in this important moment. Our results showed the central role of communication between the family and the emergency care team in facilitating the acceptance of the reality of death.
Smith, Stephen Ridley; Draganic, Brian; Pockney, Peter; Holz, Phillip; Holmes, Ryan; Mcmanus, Brendan; Carroll, Rosemary
Adequate postoperative analgesia is essential for recovery following colorectal surgery. Transversus abdominis plane (TAP) blocks have been found to be beneficial in improving pain following a variety of abdominal operations. The objective of this study was to determine if TAP blocks are useful in improving postoperative recovery following laparoscopic colorectal surgery. A prospective double-blind randomized clinical trial, involving 226 consecutive patients having laparoscopic colorectal surgery, was performed by a university colorectal surgical department. Patients were randomized to either TAP blockade using ultrasound guidance, or control, with the primary outcome being postoperative pain, as measured by analgesic consumption. Secondary outcomes assessed were pain visual analogue score (VAS), respiratory function, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. A total of 142 patients were followed up to trial completion (74 controls, 68 interventions). Patients were well matched with regard to demographics. No complications occurred as a result of the intervention of TAP blockade. There was no difference between groups with regards to analgesic consumption (161 mEq morphine control vs 175 mEq morphine TAP; p = 0.596). There was no difference between the two groups with regards to the secondary outcomes of daily VAS, respiratory outcome, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. We conclude that TAP blockade appears to be a safe intervention but confers no specific advantage following laparoscopic colorectal surgery.
Gula, Taras; Hoessler, Carolyn; Maciejewski, Wes
Many students enter the Canadian college system with insufficient mathematical ability and leave the system with little improvement. Those students who enter with poor mathematics ability typically take a developmental mathematics course as their first and possibly only mathematics course. The educational experiences that comprise a developmental mathematics course vary widely and are, too often, ineffective at improving students' ability. This trend is concerning, since low mathematics ability is known to be related to lower rates of success in subsequent courses. To date, little attention has been paid to the selection of an instructional approach to consistently apply across developmental mathematics courses. Prior research suggests that an appropriate instructional method would involve explicit instruction and practising mathematical procedures linked to a mathematical concept. This study reports on a randomized field trial of a developmental mathematics approach at a college in Ontario, Canada. The new approach is an adaptation of the JUMP Math program, an explicit instruction method designed for primary and secondary school curriculae, to the college learning environment. In this study, a subset of courses was assigned to JUMP Math and the remainder was taught in the same style as in the previous years. We found consistent, modest improvement in the JUMP Math sections compared to the non-JUMP sections, after accounting for potential covariates. The findings from this randomized field trial, along with prior research on effective education for developmental mathematics students, suggest that JUMP Math is a promising way to improve college student outcomes.
Carla De Stefano
Full Text Available The themes of qualitative assessments that characterize the experience of family members offered the choice of observing cardiopulmonary resuscitation (CPR of a loved one have not been formally identified.In the context of a multicenter randomized clinical trial offering family members the choice of observing CPR of a patient with sudden cardiac arrest, a qualitative analysis, with a sequential explanatory design, was conducted. The aim of the study was to understand family members' experience during CPR. All participants were interviewed by phone at home three months after cardiac arrest. Saturation was reached after analysis of 30 interviews of a randomly selected sample of 75 family members included in the trial. Four themes were identified: 1- choosing to be actively involved in the resuscitation; 2- communication between the relative and the emergency care team; 3- perception of the reality of the death, promoting acceptance of the loss; 4- experience and reactions of the relatives who did or did not witness the CPR, describing their feelings. Twelve sub-themes further defining these four themes were identified. Transferability of our findings should take into account the country-specific medical system.Family presence can help to ameliorate the pain of the death, through the feeling of having helped to support the patient during the passage from life to death and of having participated in this important moment. Our results showed the central role of communication between the family and the emergency care team in facilitating the acceptance of the reality of death.
Jay, Kenneth; Frisch, Dennis; Hansen, Klaus; Zebis, Mette K; Andersen, Christoffer H; Mortensen, Ole S; Andersen, Lars L
The aim of this trial was to investigate the effectiveness of a worksite intervention using kettlebell training to improve musculoskeletal and cardiovascular health. This single-blind randomized controlled trial involved 40 adults from occupations with a high prevalence of reported musculoskeletal pain symptoms (mean age 44 years, body mass index 23 kg/m², 85% women, with pain intensity of the neck/shoulders 3.5 and of the low back 2.8 on a scale of 0-10). A blinded assessor took measures at baseline and follow-up. Participants were randomly assigned to training--consisting of ballistic full-body kettlebell exercise 3 times per week for 8 weeks--or a control group. The main outcome measures were pain intensity of the neck/shoulders and low back, isometric muscle strength, and aerobic fitness. Compared with the control group, pain intensity of the neck/shoulders decreased 2.1 points [95% confidence interval (95% CI) -3.7- -0.4] and pain intensity of the low back decreased 1.4 points (95% CI -2.7- -0.02) in the training group. Compared with the control group, the training group increased muscle strength of the trunk extensors (Pkettlebell training reduces pain in the neck/shoulders and low back and improves muscle strength of the low back among adults from occupations with a high prevalence of reported musculoskeletal pain symptoms. This type of training does not appear to improve aerobic fitness.
Gillies, Malcolm; Ranakusuma, Anggi; Hoffmann, Tammy; Thorning, Sarah; McGuire, Treasure; Glasziou, Paul; Del Mar, Christopher
When prescribing antibiotics for common indications, clinicians need information about both harms and benefits, information that is currently available only from observational studies. We quantified the common harms of the most frequently prescribed antibiotic, amoxicillin, from randomized placebo-controlled trials. For this systematic review, we searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials, without language restriction, for any randomized, participant-blinded, placebo-controlled trials of amoxicillin or amoxicillin-clavulanic acid for any indication, in any setting. Our main outcome was any reported adverse event. Of 730 studies identified, we included 45 trials: 27 involving amoxicillin, 17 involving amoxicillin-clavulanic acid and 1 involving both. The indications for antibiotic therapy were variable. The risk of bias was low, although only 25 trials provided data suitable for assessment of harms, which suggested under-reporting. Diarrhea was attributed to amoxicillin only in the form of amoxicillin-clavulanic acid (Peto odds ratio [OR] 3.30, 95% confidence interval [CI] 2.23-4.87). The OR for candidiasis (3 trials) was significantly higher (OR 7.77, 95% CI 2.23-27.11). Rashes, nausea, itching, vomiting and abnormal results on liver function tests were not significantly increased. The results were not altered by sensitivity analyses, nor did funnel plots suggest publication bias. The number of courses of antibiotics needed to harm was 10 (95% CI 6-17) for diarrhea with amoxicillin-clavulanic acid and 27 (95% CI 24-42) for candidiasis with amoxicillin (with or without clavulanic acid). Diarrhea was caused by use of amoxicillin-clavulanic acid, and candidiasis was caused by both amoxicillin and amoxicillin-clavulanic acid. Harms were poorly reported in most trials, and their true incidence may have been higher than reported. Nevertheless, these rates of common harms associated with amoxicillin therapy may inform decisions by
Full Text Available Abstract Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain. The number of patients required is 242 (121 in each arm, all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity
Hood, S C; Moher, D; Barber, G G
To evaluate the efficacy of pentoxifylline therapy in improving the walking capacity of patients with moderate intermittent claudication. A search of MEDLINE for trials published between 1976 and 1994 inclusive, and a bibliographic review of all articles retrieved. Randomized, placebo-controlled, double-blind clinical trials were selected that evaluated the pain-free walking distance (the distanced walked on a treadmill before the onset of calf pain) and the absolute claudication distance (the maximum distance walked on a treadmill) among patients with moderate intermittent claudication. Twelve study groups in 11 trials were included in the analysis. In addition to information regarding the trial design, patient characteristics, dosages and treatment periods, the means and standard deviations were collected for both the pain-free walking and absolute claudication distances. Trial quality was also assessed. Overall, there was a statistically significant improvement in the pain-free walking distance after pentoxifylline therapy (weighted mean difference 29.4 m [95% confidence interval (CI) 13.0 to 45.9 m]); this finding was based on a total sample of 612 patients (308 in the treatment groups and 304 in the control groups). A significant improvement was also noted in the absolute claudication distance (weighted mean difference 48.4 m [95% CI 18.3 to 78.6 m]); this was based on a total sample of 511 patients (258 in the treatment group and 253 in the control group). In a sensitivity analysis of the pain-free walking distance, significant treatment effects and no statistically significant heterogeneity were found when only trials were included that were "medically eligible" (involved patients with stage II disease and a pain-free walking distance of 50 to 200 m). In a similar sensitivity analysis of the absolute claudication distance, the two conditions resulting in a significant treatment effect and no significant heterogeneity were the inclusion of "medically eligible
Rea, Corinna J; Tran, Katherine D; Jorina, Maria; Wenren, Larissa M; Hawryluk, Elena B; Toomey, Sara L
To test whether an eczema care plan (ECP) would improve provider documentation and management, decrease eczema severity, and increase patient quality of life (QOL) in the pediatric primary care setting. We conducted a randomized controlled trial from June 2015 to September 2016 at a large hospital-based pediatric primary care clinic. Participants included children from 1 month to 16 years of age with a diagnosis of eczema. The intervention group received the ECP and the control group received usual care. Both groups completed a validated eczema severity scale (Patient-Oriented Eczema Measure [POEM]) and a QOL scale (Infant's Dermatitis Quality of Life Index [IDQOL]) or Children's Dermatology Life Quality Index [CDLQI]) before the visit and again ~1 month later. A total of 211 caregivers completed both the pre- and postintervention surveys (100 control group and 111 intervention group [94% completion]). Intervention group providers were more likely to recommend a comprehensive "step-up" plan (88%) vs 28%; P plan to families (80%) vs 2%; P improved between the pre- and postintervention periods. However, there was not a significant difference between the groups on either measure: POEM difference -0.8, 95% confidence interval (CI) -3.2 to 1.7; IDQOL difference -0.1, 95% CI -1.8 to 1.6; CDLQI difference 0.8, 95% CI -0.9 to 2.6. Intervention group providers documented more comprehensive eczema care than control group providers. Although patients improved on all measures in the postintervention period, the ECP did not augment that improvement. Copyright © 2018 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.
Buryk, Melissa; Bloom, David; Shope, Timothy
Ankyloglossia has been associated with a variety of infant-feeding problems. Frenotomy commonly is performed for relief of ankyloglossia, but there has been a lack of convincing data to support this practice. Our primary objective was to determine whether frenotomy for infants with ankyloglossia improved maternal nipple pain and ability to breastfeed. A secondary objective was to determine whether frenotomy improved the length of breastfeeding. Over a 12-month period, neonates who had difficulty breastfeeding and significant ankyloglossia were enrolled in this randomized, single-blinded, controlled trial and assigned to either a frenotomy (30 infants) or a sham procedure (28 infants). Breastfeeding was assessed by a preintervention and postintervention nipple-pain scale and the Infant Breastfeeding Assessment Tool. The same tools were used at the 2-week follow-up and regularly scheduled follow-ups over a 1-year period. The infants in the sham group were given a frenotomy before or at the 2-week follow-up if it was desired. Both groups demonstrated statistically significantly decreased pain scores after the intervention. The frenotomy group improved significantly more than the sham group (P frenotomy group (P = .029) without a significant change in the control group. All but 1 parent in the sham group elected to have the procedure performed when their infant reached 2 weeks of age, which prevented additional comparisons between the 2 groups. We demonstrated immediate improvement in nipple-pain and breastfeeding scores, despite a placebo effect on nipple pain. This should provide convincing evidence for those seeking a frenotomy for infants with signficant ankyloglossia.
Nowalk, Mary Patricia; Lin, Chyongchiou J; Toback, Seth L; Rousculp, Matthew D; Eby, Charles; Raymund, Mahlon; Zimmerman, Richard K
To minimize absenteeism resulting from influenza, employers frequently offer on-site influenza vaccination to employees. Yet the level of uptake of vaccine is low among working adults. This study was designed to increase workplace influenza vaccination rates by offering both a choice of intranasal (LAIV) and injectable (TIV) influenza vaccines to eligible employees, and an incentive for being vaccinated, and by increasing awareness of the vaccine clinic. This study used a stratified randomized cluster trial. A total of 12,222 employees in 53 U.S. companies with previous influenza vaccine clinics were examined. Control sites advertised and offered vaccine clinics as previously done. Choice sites offered LAIV or TIV and maintained their previous advertising level but promoted the choice of vaccines. Choice Plus sites increased advertising and promoted and offered a choice of vaccines and a nominal incentive. These included vaccination rates among eligible employees. Hierarchic linear modeling (HLM) was used to determine factors associated with vaccination. The overall vaccination rate increased from 39% in 2007-2008 to 46% in 2008-2009 (pvaccination rates for LAIV was 6.5% for Choice versus Control and 9.9% for Choice Plus versus Control (both p or =50 years (p=0.024). Rates of TIV did not change in workers aged 18-49 years in either intervention arm or in workers aged > or =50 years in the Choice arm. In HLM analyses, factors significantly associated with increased vaccination were older age, female gender, previous company vaccination rate, and the Choice Plus intervention. An incentive for vaccination, an intensified advertising campaign, and offering a choice of influenza vaccines improved vaccination rates in the workplace. Copyright (c) 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
Immenroth, Marc; Bürger, Thomas; Brenner, Jürgen; Nagelschmidt, Manfred; Eberspächer, Hans; Troidl, Hans
To evaluate the impact of a cognitive training method on the performance of simulated laparoscopic cholecystectomy in laparoscopic training courses. Surgeons are like professional sportsmen in that they have to be able to perform complicated, fine-motor movements under stressful conditions. Mental training, systematically and repeatedly imagining a movement's performance, is a well-established technique in sports science, and this study aimed to determine its value in training surgeons. A total of 98 surgeons undergoing basic laparoscopic training participated in a randomized controlled trial; 31 received additional mental training, 32 additional practical training, and 35 received no additional training (control group). All used a Pelvi-Trainer simulator to perform laparoscopic cholecystectomy at baseline and follow-up, after any additional intervention. We used a modified Objective Structured Assessment of Technical Skills (OSATS) instrument to assess performance. Principle outcome variables were the OSATS task-specific checklist (11 procedural steps, scored as correctly  or wrongly  performed) and the global rating scale (an overall performance evaluation, scored 1-5). Improvement in the task-specific checklist score between baseline and follow-up differed significantly between groups (P = 0.046 on ANOVA). Least significant difference tests yielded differences between the mental and practical training groups (P = 0.024) and between the mental training and control groups (P = 0.040), but not between the practical training and control groups (P = 0.789). Paired Student t test showed that performance at follow-up was significantly better in the mental training and control groups (mental training group, P = 0.001; control group, P = 0.018) but not the practical training group (P = 0.342). There were no significant intergroup differences in global rating scale results. Additional mental training is an effective way of optimizing the outcomes of further training
Full Text Available Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58 received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41 received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention and at a 3-month follow up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.
Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram
Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group ( n = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group ( n = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.
Fioravanti, Antonella; Bellisai, Barbara; Iacoponi, Francesca; Manica, Patrizia; Galeazzi, Mauro
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.
Bliss, Donna Z; Savik, Kay; Jung, Hans-Joachim G; Whitebird, Robin; Lowry, Ann; Sheng, Xiaoyan
Dietary fiber supplements are used to manage fecal incontinence (FI), but little is known about the fiber type to recommend or the level of effectiveness of such supplements, which appears related to the fermentability of the fiber. The aim of this single-blind, randomized controlled trial was to compare the effects of three dietary fiber supplements (carboxymethylcellulose [CMC], gum arabic [GA], or psyllium) with differing levels of fermentability to a placebo in community-living individuals incontinent of loose/liquid feces. The primary outcome was FI frequency; secondary outcomes included FI amount and consistency, supplement intolerance, and quality of life (QoL). Possible mechanisms underlying supplement effects were also examined. After a 14-day baseline, 189 subjects consumed a placebo or 16 g total fiber/day of one of the fiber supplements for 32 days. FI frequency significantly decreased after psyllium supplementation versus placebo, in both intent-to-treat and per-protocol mixed model analyses. CMC increased FI frequency. In intent-to-treat analysis, the number of FI episodes/week after supplementation was estimated to be 5.5 for Placebo, 2.5 for Psyllium, 4.3 for GA, and 6.2 for CMC. Only psyllium consumption resulted in a gel in feces. Supplement intolerance was low. QoL scores did not differ among groups. Patients with FI may experience a reduction in FI frequency after psyllium supplementation, and decreased FI frequency has been shown to be an important personal goal of treatment for patients with FI. Formation of a gel in feces appears to be a mechanism by which residual psyllium improved FI. © 2014 Wiley Periodicals, Inc.
Quiroz, Lieschen H; Shobeiri, S Abbas; Nihira, Mikio A; Brady, Jordan; Wild, Robert A
The objective of the study was to compare office rigid cystoscopy (RC) versus flexible cystoscopy (FC) in women. This was a prospective randomized trial comparing FC to RC. Aims were to assess 1-week post-procedural complications, compare procedure pain scores, and to assess physician perception of patient discomfort. Pain scores were assessed by visual analogue scale (VAS) and 5-point verbal descriptor scale (VDS). Chi-square was used for categorical comparison and t tests or Wilcoxon test for continuous variables. One hundred women were enrolled. The mean age of participants was 59.7 years (± SD 14.6), and 91 % were Caucasian. This was the first cystoscopy for 86 % of participants. On the 1-week post-procedure questionnaire (85 % response rate), participants in the FC group reported urinary frequency more often than in the RC group (p = 0.041). The FC group reported urgency with urination lasting 1-2 days (p = 0.030) and burning with urination lasting >3 days (p = 0.026), more than the RC group. These symptoms did not persist at 7 days. The duration of the procedure was slightly faster for the FC group (4.6 ± 1.8 min vs 5.7 ± 3.4 min, p = 0.046). Median VAS scores were 0.9 (0.1-2.72) for the FC group and 0.5 (0-2.4) for the RC group (p = 0.505). There were no significant differences between patient or physician perception of pain in either group. Urinary frequency and duration of urinary burning post procedure occurred more frequently in the FC group, although these symptoms were transient. Both office FC and RC are generally well tolerated in women with overall low morbidity.
Christakis, Dimitri A; Garrison, Michelle M; Herrenkohl, Todd; Haggerty, Kevin; Rivara, Frederick P; Zhou, Chuan; Liekweg, Kimberly
Although previous studies have revealed that preschool-aged children imitate both aggression and prosocial behaviors on screen, there have been few population-based studies designed to reduce aggression in preschool-aged children by modifying what they watch. We devised a media diet intervention wherein parents were assisted in substituting high quality prosocial and educational programming for aggression-laden programming without trying to reduce total screen time. We conducted a randomized controlled trial of 565 parents of preschool-aged children ages 3 to 5 years recruited from community pediatric practices. Outcomes were derived from the Social Competence and Behavior Evaluation at 6 and 12 months. At 6 months, the overall mean Social Competence and Behavior Evaluation score was 2.11 points better (95% confidence interval [CI]: 0.78-3.44) in the intervention group as compared with the controls, and similar effects were observed for the externalizing subscale (0.68 [95% CI: 0.06-1.30]) and the social competence subscale (1.04 [95% CI: 0.34-1.74]). The effect for the internalizing subscale was in a positive direction but was not statistically significant (0.42 [95% CI: -0.14 to 0.99]). Although the effect sizes did not noticeably decay at 12 months, the effect on the externalizing subscale was no longer statistically significant (P = .05). In a stratified analysis of the effect on the overall scores, low-income boys appeared to derive the greatest benefit (6.48 [95% CI: 1.60-11.37]). An intervention to reduce exposure to screen violence and increase exposure to prosocial programming can positively impact child behavior.
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.
Smith-Hicks, Constance L; Gupta, Siddharth; Ewen, Joshua B; Hong, Manisha; Kratz, Lisa; Kelley, Richard; Tierney, Elaine; Vaurio, Rebecca; Bibat, Genila; Sanyal, Abanti; Yenokyan, Gayane; Brereton, Nga; Johnston, Michael V; Naidu, Sakkubai
To determine safety and perform a preliminary assessment of dose-dependent efficacy of dextromethorphan in normalizing electrographic spikes, clinical seizures, and behavioral and cognitive functions in girls with Rett syndrome. We used a prospective randomized, open-label trial in fast metabolizers of dextromethorphan to examine the effect of dextromethorphan on core clinical features of Rett syndrome. Interictal spike activity and clinical seizures were determined using EEG and parent reporting. Cognitive data were obtained using the Mullen Scales of Early Learning and Vineland Adaptive Behavior Scales, while behavioral data were obtained from parent-completed checklists, the Aberrant Behavior Checklist-Community Version, and the Screen for Social Interaction. Anthropometric data were obtained according to the National Health and Nutrition Examination Survey. The Rett Syndrome Severity Scale provided a clinical global impression of the effect of dextromethorphan on clinical severity. Dextromethorphan is safe for use in 3- to 15-year-old girls with Rett syndrome. Thirty-five girls were treated with 1 of 3 doses of dextromethorphan over a period of 6 months. Statistically significant dose-dependent improvements were seen in clinical seizures, receptive language, and behavioral hyperactivity. There was no significant improvement in global clinical severity as measured by the Rett Syndrome Severity Scale. Dextromethorphan is a potent noncompetitive antagonist of the NMDA receptor channel that is safe for use in young girls with Rett syndrome. Preliminary evidence suggests that dextromethorphan may improve some core features of Rett syndrome. This study provides Class IV evidence that dextromethorphan at various doses does not change EEG spike counts over 6 months, though precision was limited to exclude an important effect. © 2017 American Academy of Neurology.
Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X
The necessary foundation for good clinical practice lies in knowledge derived from clinical research. Evidence from randomized clinical trials (RCTs) is the pillar on which decisions about therapy are based. To search exhaustively and rigorously to identify RCTs in dermatology journals published in Spanish. We located dermatology journals through the following search engines and indexes: PubMed, LILACS, SciELO, Periódica, Latindex, Índice Médico Español, C-17, IBECS, EMBASE, and IMBIOMED. We also sought information through dermatology associations and dermatologists in countries where Spanish was the usual language of publication, and we searched the Internet (Google). Afterwards we searched the journals electronically and manually to identify RCTs in all available volumes and issues, checking from the year publication started through 2012. Of 28 journals identified, we included 21 in the search. We found a total of 144 RCTs published since 1969; 78 (54%) were in Latin American journals and 66 (46%) were in Spanish journals. The most frequent disease contexts for RCTs in Spanish journals were psoriasis, mycoses, and acne vulgaris. In Latin American journals, the most frequent disease contexts were common warts, mycoses, acne vulgaris, and skin ulcers on the lower limbs. Manual searches identified more RCTs than electronic searches. Manual searches found a larger number of RCTs. Relatively fewer RCTs are published in Spanish and Latin American journals than in English-language journals. Internet facilitated access to full texts published by many journals; however, free open access to these texts is still unavailable and a large number of journal issues are still not posted online. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.
Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Andersen, Lars L
While benefits of workplace physical exercise on physical health is well known, little is known about the psychosocial effects of such initiatives. This study evaluates the effect of workplace versus home-based physical exercise on psychosocial factors among healthcare workers. A total of 200 female healthcare workers (Age: 42.0, BMI: 24.1) from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 10 min 5 days per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 10 min 5 days per week and up to 5 group-based coaching sessions on motivation for regular physical exercise. Vitality and mental health (SF-36, scale 0-100), psychosocial work environment (COPSOQ, scale 0-100), work- and leisure disability (DASH, 0-100), control- (Bournemouth, scale 0-10) and concern about pain (Pain Catastrophizing Scale, scale 0-10) were assessed at baseline and at 10-week follow-up. Vitality as well as control and concern about pain improved more following WORK than HOME (all p mental health remained unchanged. Between-group differences at follow-up (WORK vs. HOME) were 7 [95% confidence interval (95% CI) 3 to 10] for vitality, -0.8 [95% CI -1.3 to -0.3] for control of pain and -0.9 [95% CI -1.4 to -0.5] for concern about pain, respectively. Performing physical exercise together with colleagues during working hours was more effective than home-based exercise in improving vitality and concern and control of pain among healthcare workers. These benefits occurred in spite of increased work pace. NCT01921764 at ClinicalTrials.gov . Registered 10 August 2013.
Kirscht, Jade; Weiss, Christel; Nickol, Jana; Berlit, Sebastian; Tuschy, Benjamin; Hoch, Benjamin; Trebin, Amelie-Verena; Große-Steffen, Thomas; Sütterlin, Marc; Kehl, Sven
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.
Henaux, Pierre-Louis; Le Reste, Pierre-Jean; Laviolle, Bruno; Morandi, Xavier
Chronic subdural hematoma (CSDH) is a common neurological pathology, especially in older patients. The actual "gold standard" of treatment is surgical evacuation, with various techniques used across neurosurgical teams. Over the years, there has been growing evidence that inflammatory processes play a major role in the pathogenesis of CSDH. In that context, the use of corticosteroids has been proposed alone or as an adjuvant treatment to surgery. However, this practice remains very empirical and there is a need for high-quality-of-evidence studies to clarify the role of corticosteroids in the management of CSDH. We propose a double-blind, randomized controlled trial comparing methylprednisolone versus placebo in the treatment of CSDH without clinical and/or radiological signs of severity. The treatment will be administered daily for a duration of 3 weeks, at a dose of 1 mg/kg. The primary endpoint will be the delay of occurrence of surgical treatment at 1 month following the introduction of the treatment. Secondary endpoints will include the rate of recourse to surgery, survival rate, quality of life and functional assessments, occurrence of systemic secondary effects and radiological assessment of the response to treatment. This multimodal assessment will be done at 1, 3 and 6 months. Two hundred and two patients (101 per arm) are expected to be included considering our primary hypotheses. This trial started in June 2016; its results may open interesting alternatives to surgery in the management of patients harboring a CSDH, and may provide insights into the natural history of this common pathology. ClinicalTrials.gov, ID: NCT02650609 . Registered on 4 January 2016. Graphical output of the OBF boundaries.
Liu, Rosemarie H; Smith, Molly K; Basta, Sameh A; Farmer, Evan R
To evaluate the clinical efficacy of topical 20% azelaic acid cream and 15% azelaic acid gel compared with their respective vehicles and metronidazole gel in the treatment of papulopustular rosacea. Electronic searches of MEDLINE, EMBASE, BIOSIS, and SciSearch through July or August 2004 and the Cochrane Central Register of Controlled Trials through 2004 (issue 3). We performed hand searches of reference lists, conference proceedings, and clinical trial databases. Experts in rosacea and azelaic acid were contacted. Randomized controlled trials involving topical azelaic acid (cream or gel) for the treatment of rosacea compared with placebo or other topical treatments. Two authors independently examined the studies identified by the searches. Ten studies were identified, of which 5 were included (873 patients). Two authors independently extracted data from the included studies, then jointly assessed methodological quality using a quality assessment scale. Because standard deviation data were not available for 4 of the 5 studies, a meta-analysis could not be conducted. Four of the 5 studies demonstrated significant decreases in mean inflammatory lesion count and erythema severity after treatment with azelaic acid compared with vehicle. None of the studies showed any significant decrease in telangiectasia severity. Azelaic acid in 20% cream and 15% gel formulations appears to be effective in the treatment of papulopustular rosacea, particularly in regard to decreases in mean inflammatory lesion count and erythema severity. Compared with metronidazole, azelaic acid appears to be an equally effective, if not better, treatment option.
Astin, J A; Harkness, E; Ernst, E
To conduct a systematic review of the available data on the efficacy of any form of "distant healing" (prayer, mental healing, Therapeutic Touch, or spiritual healing) as treatment for any medical condition. Studies were identified by an electronic search of the MEDLINE, PsychLIT, EMBASE, CISCOM, and Cochrane Library databases from their inception to the end of 1999 and by contact with researchers in the field. Studies with the following features were included: random assignment, placebo or other adequate control, publication in peer-reviewed journals, clinical (rather than experimental) investigations, and use of human participants. Two investigators independently extracted data on study design, sample size, type of intervention, type of control, direction of effect (supporting or refuting the hypothesis), and nature of the outcomes. A total of 23 trials involving 2774 patients met the inclusion criteria and were analyzed. Heterogeneity of the studies precluded a formal meta-analysis. Of the trials, 5 examined prayer as the distant healing intervention, 11 assessed noncontact Therapeutic Touch, and 7 examined other forms of distant healing. Of the 23 studies, 13 (57%) yielded statistically significant treatment effects, 9 showed no effect over control interventions, and 1 showed a negative effect. The methodologic limitations of several studies make it difficult to draw definitive conclusions about the efficacy of distant healing. However, given that approximately 57% of trials showed a positive treatment effect, the evidence thus far merits further study.
Schluter Philip J
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
Turner, Elizabeth L; Li, Fan; Gallis, John A; Prague, Melanie; Murray, David M
In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have highlighted the developments of the past 13 years in design with a companion article to focus on developments in analysis. As a pair, these articles update the 2004 review. We have discussed developments in the topics of the earlier review (e.g., clustering, matching, and individually randomized group-treatment trials) and in new topics, including constrained randomization and a range of randomized designs that are alternatives to the standard parallel-arm GRT. These include the stepped-wedge GRT, the pseudocluster randomized trial, and the network-randomized GRT, which, like the parallel-arm GRT, require clustering to be accounted for in both their design and analysis.
Gorrell, Lindsay M; Brown, Benjamin; Lystad, Reidar P; Engel, Roger M
While spinal manipulative therapy (SMT) is recommended for the treatment of spinal disorders, concerns exist about adverse events associated with the intervention. Adequate reporting of adverse events in clinical trials would allow for more accurate estimations of incidence statistics through meta-analysis. However, it is not currently known if there are factors influencing adverse events reporting following SMT in randomized clinical trials (RCTs). Thus our objective was to investigate predictive factors for the reporting of adverse events in published RCTs involving SMT. The Physiotherapy Evidence Database (PEDro) and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included: sample size; publication date relative to the 2010 CONSORT statement; risk of bias; the region treated; and number of intervention sessions. 7398 records were identified, of which 368 articles were eligible for inclusion. A total of 140 (38.0%) articles reported on adverse events. Articles were more likely to report on adverse events if they possessed larger sample sizes, were published after the 2010 CONSORT statement, had a low risk of bias and involved multiple intervention sessions. The region treated was not a significant predictor for reporting on adverse events. Predictors for reporting on adverse events included larger sample size, publication after the 2010 CONSORT statement, low risk of bias and trials involving multiple intervention sessions. We recommend that researchers focus on developing robust methodologies and participant follow-up regimens for RCTs involving SMT. Copyright © 2017 Elsevier Ltd. All rights reserved.
Full Text Available Abstract Background Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA with volatile-based neuroanaesthesia (VA has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intravenous anaesthetics in addition to narcotics. Actually the choice of the anaestesiological strategy depends only on the anaesthetists' preferences or institutional policies. This trial, named NeuroMorfeo, aims to assess the equivalence between volatile and intravenous anaesthetics for neurosurgical procedures. Methods/Design NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state (ASA I-III and Glasgow Coma Scale (GCS equal to 15, are randomly assigned to one of three anaesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil. The equivalence between intravenous and volatile-based neuroanaesthesia will be evaluated by comparing the intervals required to reach, after anaesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point. Two statistical comparisons have been planned: 1 sevoflurane + fentanyl vs. propofol + remifentanil; 2 sevoflurane + remifentanil vs. propofol + remifentanil. Secondary end-points include: an assessment of neurovegetative stress based on (a measurement of urinary catecholamines and plasma and urinary cortisol and (b estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded
Pitkälä, Kaisu H; Pöysti, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo S; Savikko, Niina; Kautiainen, Hannu; Strandberg, Timo E
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.
Chiu, Hsiao-Yean; Huang, Hui-Chuan; Chen, Pin-Yuan; Hou, Wen-Hsuan; Tsai, Pei-Shan
To evaluate the effectiveness of walking exercise on sleep in people with cancer. Databases searched included China Knowledge Resource Integrated Database, CINAHL®, Cochrane Central Register of Controlled Trials, EMBASE, PsycINFO®, PubMed, Wanfang Data, and Web of Science. Nine randomized, controlled trials involving 599 patients were included. Most of the studies used moderate-intensity walking exercise. Overall, walking exercise significantly improved sleep in people with cancer (Hedges' g = –0.52). Moderator analyses showed that walking exercise alone and walking exercise combined with other forms of interventions yielded comparable effects on sleep improvement, and that the effect size did not differ among participants who were at different stages of cancer. The effect sizes for studies involving individuals with breast cancer and for studies including individuals with other types of cancer were similar. Moderate-intensity walking exercise is effective in improving sleep in individuals with cancer. The authors' findings support the inclusion of walking exercise into the multimodal approaches to managing sleep in people with cancer. Healthcare providers must convey the benefits of walking exercise to individuals with cancer who are suffering from sleep problems.
Tilbrook, Helen E; Becque, Taeko; Buckley, Hannah; MacPherson, Hugh; Bailey, Mathew; Torgerson, David J
Attrition is a threat to the validity of randomized trials. Few randomized studies have been conducted within randomized trials to test methods of reducing attrition. To test whether using yellow post-it notes on follow-up questionnaires in the ATLAS treatment trial for neck pain reduces attrition. Nested trial within a trial. ATLAS participants were randomized to have their 6-month follow-up questionnaire have a 3' yellow post-it note with a handwritten message encouraging return of questionnaire. 499 participants were independently randomized using simple allocation to receive the post-it notes or not. Two hundred fifteen of the 256 (84.0%) participants in the intervention group returned their questionnaire compared with 205 of the 243 (84.4%) in the control group. There was no difference in time to response. Yellow post-it notes do not enhance questionnaire return rates for participants in a randomized trial of neck pain. © 2014 John Wiley & Sons, Ltd.
Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.
Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.
Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: email@example.com [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)
Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.
Fron Chabouis, Hélène; Chabouis, Francis; Gillaizeau, Florence; Durieux, Pierre; Chatellier, Gilles; Ruse, N Dorin; Attal, Jean-Pierre
Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques. The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial. Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed. A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge. This software will help investigators choose the appropriate randomization method in future two-arm trials.
Janka, A; Adler, C; Brunner, B; Oppenrieder, S; Duschek, S
Working in crisis environments represents a major challenge, especially for executive personnel engaged in directing disaster operations, i.e. crisis managers. Crisis management involves operating under conditions of extreme stress resulting, for instance, from high-level decision-making, principal responsibility for personnel, multitasking or working under conditions of risk and time pressure. The present study aimed to investigate the efficacy of a newly developed biofeedback training procedure based on electrodermal activity, especially designed for the target group of crisis managers. The training comprised exercises promoting acquisition of control over sympathetic arousal under resting conditions and during exposure to visual, acoustic and cognitive stressors resembling situations related to crisis management. In a randomized controlled design, 36 crisis managers were assigned to either a biofeedback training group or waiting list control group. Subjective stress was assessed using the Perceived Stress Scale. In the training group, stress level markedly decreased; the decrease remained stable at follow-up 2 months after the training. The results indicate that biofeedback training in crisis management is an effective method for stress management that may help to reduce vulnerability to stress-related performance decline and stress-related disease.
Jul 7, 2010 ... cluster randomIzed trIal of the uptake of a take-home Infant dose of nevIrapIne In kenya. H. W. ReynOldS, O. GACHunO, J. kAyITA, m. A. HAyS and J. RAkWAR, abstract. Objective: to test whether a single take home dose of infant nevirapine increased infant uptake without decreasing institutional deliveries.
Reynolds, Shirley A; Clark, Sarah; Smith, Holly; Langdon, Peter E; Payne, Ruth; Bowers, Gemma; Norton, Elisabeth; McIlwham, Harriet
Obsessive-compulsive disorder (OCD) in young people can be effectively treated with Cognitive Behavior Therapy (CBT). Practice guidelines in the United Kingdom recommend that CBT be delivered with parental or family involvement; however, there is no evidence from randomized trials that this enhances effectiveness. The aim of this trial was to assess if CBT with high parental involvement was more effective than CBT with low parental involvement (individual CBT) in reducing symptoms of OCD. Fifty young people ages 12-17 years with OCD were randomly allocated to individual CBT or parent-enhanced CBT. In parent-enhanced CBT parents attended all treatment sessions; in individual CBT, parents attended only Sessions 1, 7, and the final session. Participants received up to 14 sessions of CBT. Data were analyzed using intent-to-treat and per-protocol methods. The primary outcome measure was the Children's Yale-Brown Obsessive Compulsion Scale (Scahill et al., 1997). Both forms of CBT significantly reduced symptoms of OCD and anxiety. Change in OCD symptoms was maintained at 6 months. Per-protocol analysis suggested that parent-enhanced CBT may be associated with significantly larger reductions in anxiety symptoms. High and low parental involvement in CBT for OCD in young people were both effective, and there was no evidence that 1 method of delivery was superior on the primary outcome measure. However, this study was small. Future trials should be adequately powered and examine interactions with the age of the young person and comorbid anxiety disorders.
Weijers, Jonas; Ten Kate, Coriene; Eurelings-Bontekoe, Elisabeth; Viechtbauer, Wolfgang; Rampaart, Rutger; Bateman, Anthony; Selten, Jean-Paul
Many patients with a non-affective psychotic disorder suffer from impairments in social functioning and social cognition. To target these impairments, mentalization-based treatment for psychotic disorder, a psychodynamic treatment rooted in attachment theory, has been developed. It is expected to improve social cognition, and thereby to improve social functioning. The treatment is further expected to increase quality of life and the awareness of having a mental disorder, and to reduce substance abuse, social stress reactivity, positive symptoms, negative, anxious and depressive symptoms. The study is a rater-blinded randomized controlled trial. Patients are offered 18 months of therapy and are randomly allocated to mentalization-based treatment for psychotic disorders or treatment as usual. Patients are recruited from outpatient departments of the Rivierduinen mental health institute, the Netherlands, and are aged 18 to 55 years and have been diagnosed with a non-affective psychotic disorder. Social functioning, the primary outcome variable, is measured with the social functioning scale. The administration of all tests and questionnaires takes approximately 22 hours. Mentalization-based treatment for psychotic disorders adds a total of 60 hours of group therapy and 15 hours of individual therapy to treatment as usual. No known health risks are involved in the study, though it is known that group dynamics can have adverse effects on a psychiatric disorder. If Mentalization-based treatment for psychotic disorders proves to be effective, it could be a useful addition to treatment. Dutch Trial Register. NTR4747 . Trial registration date 08-19-2014.
Cox, Elizabeth D; Jacobsohn, Gwen C; Rajamanickam, Victoria P; Carayon, Pascale; Kelly, Michelle M; Wetterneck, Tosha B; Rathouz, Paul J; Brown, Roger L
Family-centered rounds (FCRs) have become standard of care, despite the limited evaluation of FCRs' benefits or interventions to support high-quality FCR delivery. This work examines the impact of the FCR checklist intervention, a checklist and associated provider training, on performance of FCR elements, family engagement, and patient safety. This cluster randomized trial involved 298 families. Two hospital services were randomized to use the checklist; 2 others delivered usual care. We evaluated the performance of 8 FCR checklist elements and family engagement from 673 pre- and postintervention FCR videos and assessed the safety climate with the Children's Hospital Safety Climate Questionnaire. Random effects regression models were used to assess intervention impact. The intervention significantly increased the number of FCR checklist elements performed (β = 1.2, P checklist elements was associated with changes in these outcomes. For example, order read-back was associated with significantly more family engagement. Asking families for questions was associated with significantly better ratings of staff's communication openness and safety of handoffs and transitions. The performance of FCR checklist elements was enhanced by checklist implementation and associated with changes in family engagement and more positive perceptions of safety climate. Implementing the checklist improves delivery of FCRs, impacting quality and safety of care. Copyright © 2017 by the American Academy of Pediatrics.
Ackermann, Ronald T; Sandy, Lewis G; Beauregard, Tom; Coblitz, Mark; Norton, Kristi L; Vojta, Deneen
Objective To evaluate the use and effectiveness of two “in-home” strategies for delivering diabetes prevention programming using cable television. Methods An individually randomized, two-arm intervention trial including adults with diabetes risk factors living in two US cities. Interventions involved a 16-session lifestyle intervention delivered via “video-on-demand” cable television, offered alone versus in combination with web-based lifestyle support tools. Repeated measures longitudinal linear regression with imputation of missing observations was used to compare changes in body weight. Results A total of 306 individuals were randomized and offered the interventions. After 5 months, 265 (87%) participants viewed at least 1, and 110 (36%) viewed ≥9 of the video episodes. A total of 262 (86%) participants completed a 5-month weight measurement. In intention-to-treat analysis with imputation of missing observations, mean weight loss at 5 months for both treatment groups combined was 3.3% (95% CI 0.7-5.0%), regardless of intervention participation (with no differences between randomized groups (P = 0.19)), and was 4.9% (95% CI 2.1-6.5%) for participants who viewed ≥9 episodes. Conclusions In-home delivery of evidence-based diabetes prevention programming in a reality television format, offered with or without online behavioral support tools, can achieve modest weight losses consistent with past implementation studies of face-to-face programs using similar content. PMID:24740868
Dickinson, L Miriam; Beaty, Brenda; Fox, Chet; Pace, Wilson; Dickinson, W Perry; Emsermann, Caroline; Kempe, Allison
Cluster randomized trials (CRTs) are useful in practice-based research network translational research. However, simple or stratified randomization often yields study groups that differ on key baseline variables when the number of clusters is small. Unbalanced study arms constitute a potentially serious methodological problem for CRTs. Covariate constrained randomization with data on relevant variables before randomization was used to achieve balanced study arms in 2 pragmatic CRTs. In study 1, 16 counties in Colorado were randomized to practice-based or population-based reminder recall for vaccinating children ages 19 to 35 months. In study 2, 18 primary care practices were randomized to computer decision support plus practice facilitation versus computer decision support alone to improve care for patients with stage 3 and 4 chronic kidney disease. For each study, a set of optimal randomizations, which minimized differences of key variables between study arms, was identified from the set of all possible randomizations. Differences between study arms were smaller in the optimal versus remaining randomizations. Even for the randomization in the optimal set with the largest difference between groups, study arms did not differ significantly on any variable for either study (P > .05). Covariate constrained randomization, which restricts the full randomization set to a subset in which differences between study arms are minimized, is a useful tool for achieving balanced study arms in CRTs. Because of the increasing recognition of the risk of imbalance in CRTs and implications for interpreting study findings, procedures of this type should be considered in designing practice-based or community-based trials. © Copyright 2015 by the American Board of Family Medicine.
Otto, Marit; Bach, Flemming W; Jensen, Troels S
Serotonin (5-HT) is involved in pain modulation via descending pathways in the central nervous system. The aim of this study was to test if escitalopram, a selective serotonin reuptake inhibitor (SSRI), would relieve pain in polyneuropathy. The study design was a randomized, double-blind, placebo......-controlled cross-over trial. The daily dose of escitalopram was 20mg once daily. During the two treatment periods of 5 weeks duration, patients rated pain relief (primary outcome variable) on a 6-point ordered nominal scale. Secondary outcome measures comprised total pain and different pain symptoms (touch...... in the data analysis. Patients reported a better pain relief during treatment with escitalopram compared with placebo (p=0.001). Total pain and different pain symptoms were lower during escitalopram treatment (p=0.001-0.024). The Number needed to treat (NNT) to obtain one patient with good or complete pain...
Frobell, Richard B; Roos, Ewa M; Roos, Harald P
no significant differences between the two treatment groups with respect to secondary outcomes. Adverse events were common in both groups. The results were similar when the data were analyzed according to the treatment actually received. CONCLUSIONS: In young, active adults with acute ACL tears, a strategy......BACKGROUND: The optimal management of a torn anterior cruciate ligament (ACL) of the knee is unknown. METHODS: We conducted a randomized, controlled trial involving 121 young, active adults with acute ACL injury in which we compared two strategies: structured rehabilitation plus early ACL...... reconstruction and structured rehabilitation with the option of later ACL reconstruction if needed. The primary outcome was the change from baseline to 2 years in the average score on four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS) - pain, symptoms, function in sports and recreation...
Ivanic, Gerd M; Pink, Peter T; Schneider, Frank; Stuecker, Markus; Homann, Nicolaus C; Preidler, Klaus W
A randomized clinical trial compared two materials used to prevent epidural scarring after microdiscectomy. To determine whether ADCON-L Gel (ALG) or Preclude Spinal Membrane (PSM) was more effective in preventing scarring, reducing pain, and improving quality of life postoperatively. Postdiscectomy syndrome may result from epidural scarring. Various materials have been used in attempts to prevent this problem, but none have provided optimal results. Previous laboratory and clinical studies have found ALG and PSM to be effective, but none compared the two materials. Thirty-one patients undergoing primary microdiscectomy were randomly assigned to receive either ALG or PSM. Postoperatively, patients were evaluated by magnetic resonance imaging (MRI), with contrast, for volume and rostral-caudal extent of scar tissue and nerve root involvement. Back and leg pain and quality of life were assessed by neurologic examinations and standardized patient surveys. Findings at any reoperations were recorded. Results in the PSM (n = 18) and ALG (n = 13) groups were compared statistically. No operative or postoperative complications occurred. Two patients in each group required reoperation. MRI at 6 months showed no, mild or mild-moderate scarring in most patients, with no significant differences between the ALG and PSM groups in scar volume and extent or nerve root involvement. Neurologic examinations and patient surveys showed substantial reductions in pain over time in both groups but no significant differences between groups. PSM was easy to see and remove at reoperation. PSM and ALG are equally effective in preventing epidural scarring associated with postdiscectomy syndrome.
Santini, Paolla Magioni; Williams, Lucia C A
This study evaluated a positive parenting program to Brazilian mothers who used corporal punishment with their children. The intervention was conducted in four agencies serving vulnerable children, and at a home replica laboratory at the University. Mothers who admitted using corporal punishment were randomly assigned between experimental (n=20) and control group (n=20). The program consisted of 12 individual sessions using one unit from Projeto Parceria (Partnership Project), with specific guidelines and materials on positive parenting, followed by observational sessions of mother-child interaction with live coaching and a video feedback session in the lab. The study used an equivalent group experimental design with pre/post-test and follow-up, in randomized controlled trials. Measures involved: Initial Interview; Strengths and Difficulties Questionnaire (SDQ) - parent and child versions; Beck Depression Inventory (BDI); observational sessions with a protocol; and a Program Evaluation by participants. Analysis of mixed models for repeated measures revealed significant positive effects on the BDI and SDQ total scores, as well as less Conduct problems and Hyperactivity in SDQ measures from the experimental group mothers, comparing pre with post-test. Observational data also indicated significant improvement in positive interaction from the experimental group mothers at post-test, in comparison with controls. No significant results were found, however, in children's observational measures. Limitations of the study involved using a restricted sample, among others. Implications for future research are suggested. Copyright © 2017 Elsevier Ltd. All rights reserved.
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.
Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu
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 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.
Rosenbaum, S; Sherrington, C; Tiedemann, A
To investigate the impact of a 12-week exercise programme in addition to usual care for post-traumatic stress disorder (PTSD). An assessor-blinded randomized controlled trial was conducted among 81 participants with a DSM-IV-TR diagnosis of primary PTSD. Participants were recruited after admission to an in-patient programme at a private hospital. Participants were randomized to receive either usual care (n=42), or exercise in addition to usual care (n=39). The exercise intervention involved three, 30-min resistance-training sessions/week and a pedometer-based walking programme. Usual care involved psychotherapy, pharmaceutical interventions, and group therapy. Primary outcome was PTSD symptoms assessed via the PTSD checklist-civilian version (PCL-C). Secondary outcomes included symptoms of depression, anthropometry, physical activity, mobility, strength, and sleep quality. Participants had a mean (SD) age of 47.8 years (12.1), 84% male. PTSD symptoms in the intervention group significantly reduced compared with the usual care group (mean difference=-5.4, 95% CI -10.5 to -0.3, P=0.04, n=58). There were significant between-group differences at follow-up for depressive symptoms, waist circumference, sleep quality, and sedentary time. This study provides the first evidence that an exercise intervention is associated with reduced PTSD and depressive symptoms, reduced waist circumference, and improved sleep quality. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar
To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...... for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have been made on an individual level. Methods of accounting for clustering in design and analysis were......, and the trials generally improved in quality. CONCLUSIONS: Shortcomings exist in the sample-size calculations and in the analysis of cluster-randomized trials conducted during maternal and child health research in developing countries. Even though there has been improvement over time, further progress in the way...
Tehranisa, Jason S; Meurer, William J
A response-adaptive randomization (RAR) trial design actively adjusts the ratio of participants assigned to each trial arm, favoring the better performing treatment by using outcome data from participants already in the trial. Compared with a standard clinical trial, an RAR study design has the potential to improve patient participation in acute stroke trials. This cross-sectional randomized survey included adult emergency department patients, age≥18, without symptoms of stroke or other critical illness. A standardized protocol was used, and subjects were randomized to either an RAR or standard hypothetical acute stroke trial. After viewing the video describing the hypothetical trial (http://youtu.be/cKIWduCaPZc), reviewing the consent form, and having questions answered, subjects indicated whether they would consent to the trial. A multivariable logistic regression model was fitted to estimate the impact of RAR while controlling for demographic factors and patient understanding of the design. A total of 418 subjects (210 standard and 208 RAR) were enrolled. All baseline characteristics were balanced between groups. There was significantly higher participation in the RAR trial (67.3%) versus the standard trial (54.5%), absolute increase: 12.8% (95% confidence interval, 3.7-22.2). The RAR group had a higher odds ratio of agreeing to research (odds ratio, 1.89; 95% confidence interval, 1.2-2.9) while adjusting for patient level factors. Trial designs were generally well understood by the participants. The hypothetical RAR trial attracted more research participation than standard randomization. RAR has the potential to increase recruitment and offer benefit to future trial participants. © 2014 American Heart Association, Inc.
Folke, Sofie; Daniel, Sarah Ingrid Franksdatter; Poulsen, Stig Bernt
Objective: This study investigated the relation between clients’ attachment patterns and the therapeutic alliance in two psychotherapies for bulimia nervosa. Method: Data derive from a randomized clinical trial comparing cognitive-behavioral therapy and psychoanalytic psychotherapy for bulimia...
Stéphanie J.E. Becker
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.
Eriksson, Goran; Calverley, Peter M.; Jenkins, Christine R.; Anzueto, Antonio R.; Make, Barry J.; Lindberg, Magnus; Fageras, Malin; Postma, Dirkje S.
Background: When discontinuation in COPD randomized controlled trials (RCTs) is unevenly distributed between treatments (differential dropout), the capacity to demonstrate treatment effects may be reduced. We investigated the impact of the time of differential dropout on exacerbation outcomes in
Vet, N.J.; Wildt, S.N. de; Verlaat, C.W.; Knibbe, C.A.; Mooij, M.G.; Woensel, J.B. van; Rosmalen, J. van; Tibboel, D.; Hoog, M. de
PURPOSE: To compare daily sedation interruption plus protocolized sedation (DSI + PS) to protocolized sedation only (PS) in critically ill children. METHODS: In this multicenter randomized controlled trial in three pediatric intensive care units in the Netherlands, mechanically ventilated critically
Vet, Nienke J.; de Wildt, Saskia N.; Verlaat, Carin W. M.; Knibbe, Catherijne A. J.; Mooij, Miriam G.; van Woensel, Job B. M.; van Rosmalen, Joost; Tibboel, Dick; de Hoog, Matthijs
To compare daily sedation interruption plus protocolized sedation (DSI + PS) to protocolized sedation only (PS) in critically ill children. In this multicenter randomized controlled trial in three pediatric intensive care units in the Netherlands, mechanically ventilated critically ill children with
Smulders, Y.E.; Zon, A. van; Stegeman, I.; Zanten, G.A.; Rinia, A.B.; Stokroos, R.J.; Free, R.H.; Maat, B.; Frijns, J.H.; Mylanus, E.A.M.; Huinck, W.J.; Topsakal, V.; Grolman, W.
OBJECTIVE: To study the cost-utility of simultaneous bilateral cochlear implantation (CI) versus unilateral CI. STUDY DESIGN: Randomized controlled trial (RCT). SETTING: Five tertiary referral centers. PATIENTS: Thirty-eight postlingually deafened adults eligible for cochlear implantation.
Richard, Edo; Kuiper, Roy; Dijkgraaf, Marcel G. W.; van Gool, Willem A.
OBJECTIVES: To investigate whether vascular care slows dementia progression in patients with Alzheimer's disease with cerebrovascular lesions on neuroimaging. DESIGN: Multicenter randomized controlled clinical trial with 2-year follow-up. SETTING: Neurological and geriatric outpatient clinics in 10
I. van der Meulen (Ineke); W.M.E. van de Sandt-Koenderman (Mieke); Heijenbrok, M.H. (Majanka H.); E.G. Visch-Brink (Evy); Ribber, G.M. (Gerard M.)
textabstractMelodic Intonation Therapy (MIT) is a language production therapy for severely nonfluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT) examining
Turner, Elizabeth L; Prague, Melanie; Gallis, John A; Li, Fan; Murray, David M
In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have updated that review with developments in analysis of the past 13 years, with a companion article to focus on developments in design. We discuss developments in the topics of the earlier review (e.g., methods for parallel-arm GRTs, individually randomized group-treatment trials, and missing data) and in new topics, including methods to account for multiple-level clustering and alternative estimation methods (e.g., augmented generalized estimating equations, targeted maximum likelihood, and quadratic inference functions). In addition, we describe developments in analysis of alternative group designs (including stepped-wedge GRTs, network-randomized trials, and pseudocluster randomized trials), which require clustering to be accounted for in their design and analysis.
Kootker, J.A.; Rasquin, S.M.C.; Lem, F.C.; Heugten, C.M. van; Fasotti, L.; Geurts, A.C.H.
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:
Engers, AJ; Wensing, M.; van Tulder, M.; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.
STUDY DESIGN.: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES.: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence
Engers, A.J.; Wensing, M.J.P.; Tulder, M.W. van; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.
STUDY DESIGN: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence to
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.
Malik, M A
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.
Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van
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
Lock, Catherine A; Kaner, Eileen; Heather, Nick; Doughty, Julie; Crawshaw, Andrea; McNamee, Paul; Purdy, Sarah; Pearson, Pauline
This paper reports an evaluation of the effectiveness and cost-effectiveness of nurse-led screening and brief intervention in reducing excessive alcohol consumption among patients in primary health care. Excessive alcohol consumption is a major source of social, economic and health problems. However, such consumption is responsive to brief alcohol intervention. To date, brief intervention research in primary health care has focused on general practitioner-led interventions, and there is only circumstantial evidence of effectiveness in nurse-led interventions. However, nurses are increasingly taking a lead in health promotion work in primary care. A pragmatic cluster-randomized controlled trial was carried out between August 2000 and June 2003 to evaluate the effects of a brief intervention compared with standard advice (control condition). A total of 40 general practice clusters (intervention = 21 and control = 19) recruited 127 patients (intervention = 67 and control = 60) to the trial. Excessive consumption was identified opportunistically via the Alcohol Use Disorders Identification Test. After baseline assessment, patients received either a 5-10 minutes brief intervention using the 'Drink-Less' protocol or standard advice (control condition). Follow-up occurred at 6 and 12 months postintervention. Analysis of variance weighted for cluster size revealed no statistically significant differences between intervention and control patients at follow up. A majority of patients in both conditions reduced their alcohol consumption between assessment and subsequent measurement. Economic analysis suggested that the brief intervention led to no statistically significant changes in subsequent health service resource use relative to standard treatment. The brief intervention evaluated in this trial had no effect over standard advice delivered by nurses in primary health care. However, there was a reduction in excessive drinking across both arms of the trial over time. Due to
Li, Yan-hui; Wang, Feng-yun; Feng, Chun-qing; Yang, Xia-feng; Sun, Yi-hua
Background Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM), the role of massage therapy in the management of FM remained controversial. Objective The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. Methods Electronic databases (up to June 2013) were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD) and 95% confidence intervals (CI) were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I2 statistic. Results Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03), anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01), and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005) in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI −0.38 to 0.75; p = 0.52). Conclusion Massage therapy with duration ≥5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings. PMID:24586677
McEachan, Rosemary R C; Lawton, Rebecca J; Jackson, Cath; Conner, Mark; Meads, David M; West, Robert M
Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B=-1.79 mm/Hg) and resting heart rate (B=-2.08 beats) and significantly increased body mass index (B=.18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. © 2011 McEachan et al; licensee BioMed Central Ltd.
Full Text Available BACKGROUND: Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM, the role of massage therapy in the management of FM remained controversial. OBJECTIVE: The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. METHODS: Electronic databases (up to June 2013 were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD and 95% confidence intervals (CI were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I(2 statistic. RESULTS: Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥ 5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03, anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01, and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005 in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI -0.38 to 0.75; p = 0.52. CONCLUSION: Massage therapy with duration ≥ 5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.
Li, Yan-hui; Wang, Feng-yun; Feng, Chun-qing; Yang, Xia-feng; Sun, Yi-hua
Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM), the role of massage therapy in the management of FM remained controversial. The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. Electronic databases (up to June 2013) were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD) and 95% confidence intervals (CI) were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I(2) statistic. Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥ 5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03), anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01), and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005) in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI -0.38 to 0.75; p = 0.52). Massage therapy with duration ≥ 5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.
Elbers Nieke A
Full Text Available Abstract Background Research has shown that current claims settlement process can have a negative impact on psychological and physical recovery of personal injury (PI victims. One of the explanations for the negative impact on health is that the claims settlement process is a stressful experience and victims suffer from renewed victimization caused by the claims settlement process. PI victims can experience a lack of information, lack of involvement, lack of 'voice', and poor communication. We present the first study that aims to empower PI victims with respect to the negative impact of the claims settlement process by means of an internet intervention. Methods/design The study is a two armed, randomized controlled trial (RCT, in which 170 PI victims are randomized to either the intervention or control group. The intervention group will get access to a website providing 1 an information module, so participants learn what is happening and what to expect during the claims settlement process, and 2 an e-coach module, so participants learn to cope with problems they experience during the claims settlement process. The control group will get access to a website with hyperlinks to commonly available information only. Participants will be recruited via a PI claims settlement office. Participants are included if they have been involved in a traffic accident which happened less than two years ago, and are at least 18 years old. The main study parameter is the increase of empowerment within the intervention group compared to the control group. Empowerment will be measured by the mastery scale and a self-efficacy scale. The secondary outcomes are perceived justice, burden, well being, work ability, knowledge, amount of damages, and lawyer-client communication. Data are collected at baseline (T0 measurement before randomization, at three months, six months, and twelve months after baseline. Analyses will be conducted according to the intention
Janssen, Patricia; Shroff, Farah; Jaspar, Paula
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
Abbott, Max; Hodgins, David C; Bellringer, Maria; Vandal, Alain C; Palmer Du Preez, Katie; Landon, Jason; Sullivan, Sean; Rodda, Simone; Feigin, Valery
Problem gambling is a significant public health issue world-wide. There is substantial investment in publicly funded intervention services, but limited evaluation of effectiveness. This study investigated three brief telephone interventions to determine whether they were more effective than standard helpline treatment in helping people to reduce gambling. Randomized clinical trial. National gambling helpline in New Zealand. A total of 462 adults with problem gambling. INTERVENTIONS AND COMPARATOR: (1) Single motivational interview (MI), (2) single motivational interview plus cognitive-behavioural self-help workbook (MI + W) and (3) single motivational interview plus workbook plus four booster follow-up telephone interviews (MI + W + B). Comparator was helpline standard care [treatment as usual (TAU)]. Blinded follow-up was at 3, 6 and 12 months. Primary outcomes were days gambled, dollars lost per day and treatment goal success. There were no differences across treatment arms, although participants showed large reductions in gambling during the 12-month follow-up period [mean reduction of 5.5 days, confidence interval (CI) = 4.8, 6.2; NZ$38 lost ($32, $44; 80.6%), improved (77.2%, 84.0%)]. Subgroup analysis revealed improved days gambled and dollars lost for MI + W + B over MI or MI + W for a goal of reduction of gambling (versus quitting) and improvement in dollars lost by ethnicity, gambling severity and psychological distress (all P gambling severity than TAU or MI at 12 months and also better for those with higher psychological distress and lower self-efficacy to MI (all P problem gambling in New Zealand, brief telephone interventions are associated with changes in days gambling and dollars lost similar to more intensive interventions, suggesting that more treatment is not necessarily better than less. Some client subgroups, in particular those with greater problem severity and greater distress, achieve better outcomes when they receive more
Moss, David A; Crawford, Paul
Sore throat is a common cause of pain in outpatient encounters. Battlefield auricular acupuncture (the placing of needles in specific points in the ear) is a modality used to treat acute pain associated with a variety of ailments. The aim of our study was to determine whether auricular acupuncture reduces pain, medication usage, and missed work hours when added to standard therapy in adult patients with acute sore throat. We conducted an unblinded, pragmatic, randomized controlled trial among adult, nonpregnant patients presenting to an Air Force family medicine clinic with pain from acute sore throat. A total of 54 patients were followed for 48 hours after treatment. Patients receiving auricular acupuncture reported lower pain scores than those who did not at 15 minutes (6.0 [95% confidence interval (CI), 5.4-6.6] vs 2.6 [95% CI, 1.7-3.5]; P vs 2.5 [95% CI, 1.6-3.4]; P = .0005), and 24 hours (4.1 [95% CI, 3.3-4.9] vs 1.3 [95% CI, 1.0-2.8]; P = .0006). They also reported taking fewer cumulative doses of pain medication at 6 hours (1.07 [95% CI, 0.69-1.45] vs 0.39 [95% CI, 0.2-0.58]; P = .003), 24 hours (2.63 [95% CI, 1.95-3.31] vs 1.37 [95% CI, 0.92-1.82]; P = .004), and 48 hours (4.07 [95% CI, 2.9-5.24] vs 2.19 [95% CI, 1.44-2.94]; P = .009). There was no difference in time missed from work between the auricular acupuncture and standard therapy groups. Compared with usual treatment, battlefield auricular acupuncture was associated with reduced sore throat pain for 24 hours and decreased use of pain medication for up to 48 hours. There was no apparent effect on hours missed from work. © Copyright 2015 by the American Board of Family Medicine.
Rueda Garrido, Juan Carlos; Vas, Jorge; Lopez, D Rafael
Shoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice, frequently causing significant functional impairment. The most common cause of shoulder pain is impingement syndrome. To decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture. Randomized controlled trial with two groups of participants: one group received true acupuncture (TA) and the other received acupuncture at sham points (SA). The treatment was carried out over 4 weeks, with the participants receiving a session every week. The results were measured immediately after the treatment (T1) and 3 months later (T2). To evaluate the results, we used the 100 mm Visual Analogue Scale (VAS), and to assess the functionality of the shoulder we employed the UCLA questionnaire (0-35 points). A total of 68 participants were included in the analysis (TA, n=35; SA, n=33), with a mean age of 33.4 years (SD 12.53). We found significant differences in the analyzed results between the two groups, as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 (CI 95% 36.7; 51.5) and 87.58 mm at T2 (CI 95% 28.32; 46.81), while the decrease in the FA group was of 19.84 mm at T1 (CI 95% 12.2; 27.4) and 20 mm at T2 (CI 95% 10.9; 29.09). When the UCLA scores were analyzed, the results were clinically meaningful in support of TA in terms of functional assessment of the shoulder. No adverse effects were reported. The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services. Copyright © 2016 Elsevier Ltd. All rights reserved.
AWARD NUMBER: W81XWH-16-1-0726 TITLE: A Randomized Controlled Trial of the Group-Based Modified Story Memory Technique in TBI PRINCIPAL...2017 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Randomized Controlled Trial of the Group-Based Modified Story Memory Technique in TBI 5b. GRANT...AVAILABILITY STATEMENT Approved for Public Release; Distribution Unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT Impairments in new learning and memory (NLM
Luke Perraton; Zuzana Machotka; Saravana Kumar
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. Onl...
Fulkerson, Jayne A.; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y.
Background Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Methods Families (n?=?160 8-12-yea...
Haedersdal, M.; Moreau, K.E.R.; Beyer, D.M.
Background and Objective: Burn scars cause permanent and disfiguring problems for many patients and limited treatments are available. Nonablative fractional lasers induce a wound healing response, which may lead to remodeling of burn sear texture. This randomized trial evaluates efficacy and adve......Background and Objective: Burn scars cause permanent and disfiguring problems for many patients and limited treatments are available. Nonablative fractional lasers induce a wound healing response, which may lead to remodeling of burn sear texture. This randomized trial evaluates efficacy...
Ferreira, Giovanni E.; Barreto, Rodrigo G. P.; Robinson, Caroline C.; Plentz, Rodrigo D. M.; Silva, Marcelo F.
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 Ri...
Macki, Mohamed; Dabaja, Ali A.
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...
Ibinda, Fredrick; Mbuba, Caroline K; Kariuki, Symon M; Chengo, Eddie; Ngugi, Anthony K; Odhiambo, Rachael; Lowe, Brett; Fegan, Greg; Carter, Julie A; Newton, Charles R
The epilepsy treatment gap is largest in resource-poor countries. We evaluated the efficacy of a 1-day health education program in a rural area of Kenya. The primary outcome was adherence to antiepileptic drugs (AEDs) as measured by drug levels in the blood, and the secondary outcomes were seizure frequency and Kilifi Epilepsy Beliefs and Attitudes Scores (KEBAS). Seven hundred thirty-eight people with epilepsy (PWE) and their designated supporter were randomized to either the intervention (education) or nonintervention group. Data were collected at baseline and 1 year after the education intervention was administered to the intervention group. There were 581 PWE assessed at both time points. At the end of the study, 105 PWE from the intervention group and 86 from the nonintervention group gave blood samples, which were assayed for the most commonly used AEDs (phenobarbital, phenytoin, and carbamazepine). The proportions of PWE with detectable AED levels were determined using a standard blood assay method. The laboratory technicians conducting the assays were blinded to the randomization. Secondary outcomes were evaluated using questionnaires administered by trained field staff. Modified Poisson regression was used to investigate the factors associated with improved adherence (transition from nonoptimal AED level in blood at baseline to optimal levels at follow-up), reduced seizures, and improved KEBAS, which was done as a post hoc analysis. This trial is registered in ISRCTN register under ISRCTN35680481. There was no significant difference in adherence to AEDs based on detectable drug levels (odds ratio [OR] 1.46, 95% confidence interval [95% CI] 0.74-2.90, p = 0.28) or by self-reports (OR 1.00, 95% CI 0.71-1.40, p = 1.00) between the intervention and nonintervention group. The intervention group had significantly fewer beliefs about traditional causes of epilepsy, cultural treatment, and negative stereotypes than the nonintervention group. There was no
Liu, Sheng; Li, Longhui; Shen, Wenwen; Shen, Xueyong; Yang, Guodong; Zhou, Wenhua
Easing psychological symptoms associated with heroin use and heroin relapse are important goals in the treatment of heroin dependence. However, most detoxification methods are designed to decrease withdrawal-related discomfort and complications, but not to reduce the psychological effects of heroin addiction. The objective of this study was to evaluate the efficacy of scopolamine detoxification technique (SDT) relative to standard methadone detoxification (MD) to treat heroin withdrawal and psychological symptoms associated with heroin use and relapse. In this 10-week randomized, controlled trial, treatment-seeking heroin-dependent participants were enrolled consecutively from Ningbo Addiction Research and Treatment Center, Ningbo, China. Opioid dependence was confirmed by a naloxone challenge test. Participants were included if they met Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for opioid dependence, were without major comorbid psychiatric illness, and were not allergic to scopolamine and chlorpromazine. Participants (N = 91; 18-50 years) were admitted to inpatient beds for 15 days and randomly assigned to receive either SDT (N = 46) or MD (N = 45) prior to being discharged and undergoing 8 weeks of outpatient treatment. During the inpatient stay, all participants received methadone during days 1-3. Those in the MD group then underwent a 10-day gradual dose-reduction regimen. Those in the SDT group underwent an SDT, such that subjects were given scopolamine (0.03-0.05 mg/kg, intravenously) and chlorpromazine (0.6-1.0 mg/kg, intravenously) under light anesthesia for 4-6 h once per day on days 4-6 or 4-7, depending on the severity of opioid-withdrawal symptoms. Self-reported withdrawal symptoms were assessed each day during the in-patient treatment phase. Heroin craving (assessed using a visual analog scale), Beck Depression Inventory, Self-Rating Anxiety Scale, and working memory and attention tests (assessed using the
Fron Chabouis, Hélène; Prot, Caroline; Fonteneau, Cyrille; Nasr, Karim; Chabreron, Olivier; Cazier, Stéphane; Moussally, Christian; Gaucher, Alexandre; Khabthani Ben Jaballah, Inès; Boyer, Renaud; Leforestier, Jean-François; Caumont-Prim, Aurore; Chemla, Florence; Maman, Louis; Nabet, Cathy; Attal, Jean-Pierre
Dental caries is a common disease and affects many adults worldwide. Inlay or onlay restoration is widely used to treat the resulting tooth substance loss. Two esthetic materials can be used to manufacture an inlay/onlay restoration of the tooth: ceramic or composite. Here, we present the protocol of a multicenter randomized controlled trial (RCT) comparing the clinical efficacy of both materials for tooth restoration. Other objectives are analysis of overall quality, wear, restoration survival and prognosis. The CEramic and COmposite Inlays Assessment (CECOIA) trial is an open-label, parallel-group, multicenter RCT involving two hospitals and five private practices. In all, 400 patients will be included. Inclusion criteria are adults who need an inlay/onlay restoration for one tooth (that can be isolated with use of a dental dam and has at least one intact cusp), can tolerate restorative procedures and do not have severe bruxism, periodontal or carious disease or poor oral hygiene. The decayed tissue will be evicted, the cavity will be prepared for receiving an inlay/onlay and the patient will be randomized by use of a centralized web-based interface to receive: 1) a ceramic or 2) composite inlay or onlay. Treatment allocation will be balanced (1:1). The inlay/onlay will be adhesively luted. Follow-up will be for 2 years and may be extended; two independent examiners will perform the evaluations. The primary outcome measure will be the score obtained with use of the consensus instrument of the Fédération Dentaire Internationale (FDI) World Dental Federation. Secondary outcomes include this instrument's items, inlay/onlay wear, overall quality and survival of the inlay/onlay. Data will be analyzed by a statistician blinded to treatments and an adjusted ordinal logistic regression model will be used to compare the efficacy of both materials. For clinicians, the CECOIA trial results may help with evidence-based recommendations concerning the choice of materials for
Cohen, Stephanie C; Mulqueen, Jilian M; Ferracioli-Oda, Eduardo; Stuckelman, Zachary D; Coughlin, Catherine G; Leckman, James F; Bloch, Michael H
Clinical practice currently restricts the use of psychostimulant medications in children with tics or a family history of tics for fear that tics will develop or worsen as a side effect of treatment. Our goal was to conduct a meta-analysis to examine the risk of new onset or worsening of tics as an adverse event of psychostimulants in randomized, placebo-controlled trials. We conducted a PubMed search to identify all double-blind, randomized, placebo-controlled trials examining the efficacy of psychostimulant medications in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). We used a fixed effects meta-analysis with risk ratio of new onset or worsening tics in children treated with psychostimulants compared to placebo. We used stratified subgroup analysis and meta-regression to examine the effects of stimulant type, dose, duration of treatment, recorder of side effect data, trial design, and mean age of participants on the measured risk of tics. We identified 22 studies involving 2,385 children with ADHD for inclusion in our meta-analysis. New onset tics or worsening of tic symptoms were commonly reported in the psychostimulant (event rate = 5.7%, 95% CI = 3.7%-8.6%) and placebo groups (event rate = 6.5%, 95% CI = 4.4%-9.5%). The risk of new onset or worsening of tics associated with psychostimulant treatment was similar to that observed with placebo (risk ratio = 0.99, 95% CI = 0.78-1.27, z = -0.05, p = .962). Type of psychostimulant, dose, duration of treatment, recorder, and participant age did not affect risk of new onset or worsening of tics. Crossover studies were associated with a significantly greater measured risk of tics with psychostimulant use compared to parallel group trials. Meta-analysis of controlled trials does not support an association between new onset or worsening of tics and psychostimulant use. Clinicians may want to consider rechallenging children who report new onset or worsening of tics with psychostimulant
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.
Robert B Couch
Full Text Available BACKGROUND: Concern for a pandemic caused by a newly emerged avian influenza A virus has led to clinical trials with candidate vaccines as preparation for such an event. Most trials have involved vaccines for influenza A (H5N1, A (H7N7 or A (H9N2. OBJECTIVE: To evaluate dosage-related safety and immunogenicity of an inactivated influenza A (H7N7 vaccine in humans. DESIGN: One hundred twenty-five healthy young adults were randomized to receive two doses intramuscularly of placebo or 7.5, 15, 45 or 90 µg of HA of an inactivated subunit influenza A (H7N7 vaccine (25 per group, four weeks apart. Reactogenicity was evaluated closely for one week and for any adverse effect for six months after each dose. Serum hemagglutination-inhibiting and neutralizing antibody responses were determined four weeks after each dose and at six months. RESULTS: Reactogenicity evaluations indicated the vaccinations were well tolerated. Only one subject developed a ≥4-fold serum hemagglutination-inhibition (HAI antibody response and a final titer of ≥1:40 four weeks after dose two and only five subjects developed a neutralizing antibody rise and a final titer of ≥1:40 in tests performed at a central laboratory. Four of the five were given the 45 or 90 µg HA dosage. A more sensitive HAI assay at the study site revealed a dose-response with increasing HA dosage but only 36% in the 90 µg HA group developed a ≥4-fold rise in antibody in this test and only one of these achieved a titer of ≥1:32. CONCLUSION: This inactivated subunit influenza A (H7N7 vaccine was safe but poorly immunogenic in humans. TRIALS REGISTRATION: ClinicalTrials.gov NCT00546585.
Full Text Available Randomized Controlled Trials almost invariably utilize the hazard ratio calculated with a Cox proportional hazard model as a treatment efficacy measure. Despite the widespread adoption of HRs, these provide a limited understanding of the treatment effect and may even provide a biased estimate when the assumption of proportional hazards in the Cox model is not verified by the trial data. Additional treatment effect measures on the survival probability or the time scale may be used to supplement HRs but a framework for the simultaneous generation of these measures is lacking.By splitting follow-up time at the nodes of a Gauss Lobatto numerical quadrature rule, techniques for Poisson Generalized Additive Models (PGAM can be adopted for flexible hazard modeling. Straightforward simulation post-estimation transforms PGAM estimates for the log hazard into estimates of the survival function. These in turn were used to calculate relative and absolute risks or even differences in restricted mean survival time between treatment arms. We illustrate our approach with extensive simulations and in two trials: IPASS (in which the proportionality of hazards was violated and HEMO a long duration study conducted under evolving standards of care on a heterogeneous patient population.PGAM can generate estimates of the survival function and the hazard ratio that are essentially identical to those obtained by Kaplan Meier curve analysis and the Cox model. PGAMs can simultaneously provide multiple measures of treatment efficacy after a single data pass. Furthermore, supported unadjusted (overall treatment effect but also subgroup and adjusted analyses, while incorporating multiple time scales and accounting for non-proportional hazards in survival data.By augmenting the HR conventionally reported, PGAMs have the potential to support the inferential goals of multiple stakeholders involved in the evaluation and appraisal of clinical trial results under proportional and
Wejse, Christian; Gomes, Victor F; Rabna, Paulo; Gustafson, Per; Aaby, Peter; Lisse, Ida M; Andersen, Paul L; Glerup, Henning; Sodemann, Morten
Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis. To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality. We conducted a randomized, double-blind, placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment. The primary outcome was reduction in a clinical severity score (TBscore) for all patients with pulmonary TB. The secondary outcome was 12-month mortality. No serious adverse effects were reported; mild hypercalcemia was rare and present in both arms. Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo. Overall mortality was 15% (54 of 365) at 1 year of follow-up and similar in both arms (30 of 187 for vitamin D treated and 24 of 178 for placebo; relative risk, 1.19 [0.58-1.95]). HIV infection was seen in 36% (131 of 359): 21% (76 of 359) HIV-1, 10% (36 of 359) HIV-2, and 5% (19 of 357) HIV-1+2. Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB; it is possible that the dose used was insufficient. Clinical trial registered with www.controlled-trials.com/isrctn (ISRCTN35212132).
Full Text Available Abstract Background Randomization is considered to be a key feature to protect against bias in randomized clinical trials. Randomization induces comparability with respect to known and unknown covariates, mitigates selection bias, and provides a basis for inference. Although various randomization procedures have been proposed, no single procedure performs uniformly best. In the design phase of a clinical trial, the scientist has to decide which randomization procedure to use, taking into account the practical setting of the trial with respect to the potential of bias. Less emphasis has been placed on this important design decision than on analysis, and less support has been available to guide the scientist in making this decision. Methods We propose a framework that weights the properties of the randomization procedure with respect to practical needs of the research question to be answered by the clinical trial. In particular, the framework assesses the impact of chronological and selection bias on the probability of a type I error. The framework is applied to a case study with a 2-arm parallel group, single center randomized clinical trial with continuous endpoint, with no-interim analysis, 1:1 allocation and no adaptation in the randomization process. Results In so doing, we derive scientific arguments for the selection of an appropriate randomization procedure and develop a template which is illustrated in parallel by a case study. Possible extensions are discussed. Conclusion The proposed ERDO framework guides the investigator through a template for the choice of a randomization procedure, and provides easy to use tools for the assessment. The barriers for the thorough reporting and assessment of randomization procedures could be further reduced in the future when regulators and pharmaceutical companies employ similar, standardized frameworks for the choice of a randomization procedure.
Kolt, Gregory S; Schofield, Grant M; Kerse, Ngaire; Garrett, Nicholas; Schluter, Philip J; Ashton, Toni; Patel, Asmita
Graded health benefits of physical activity have been demonstrated for the reduction of coronary heart disease, some cancers, and type-2 diabetes, and for injury reduction and improvements in mental health. Older adults are particularly at risk of physical inactivity, and would greatly benefit from successful targeted physical activity interventions. The Healthy Steps study is a 12-month randomized controlled trial comparing the efficacy of a pedometer-based Green Prescription with the conventional time-based Green Prescription in increasing and maintaining physical activity levels in low-active adults over 65 years of age. The Green Prescription interventions involve a primary care physical activity prescription with 3 follow-up telephone counselling sessions delivered by trained physical activity counsellors over 3 months. Those in the pedometer group received a pedometer and counselling based around increasing steps that can be monitored on the pedometer, while those in the standard Green Prescription group received counselling using time-based goals. Baseline, 3 month (end of intervention), and 12 month measures were assessed in face-to-face home visits with outcomes measures being physical activity (Auckland Heart Study Physical Activity Questionnaire), quality of life (SF-36 and EQ-5D), depressive symptoms (Geriatric Depression Scale), blood pressure, weight status, functional status (gait speed, chair stands, and tandem balance test) and falls and adverse events (self-report). Utilisation of health services was assessed for the economic evaluation carried out alongside this trial. As well, a process evaluation of the interventions and an examination of barriers and motives for physical activity in the sample were conducted. The perceptions of primary care physicians in relation to delivering physical activity counselling were also assessed. The findings from the Healthy Steps trial are due in late 2009. If successful in improving physical activity in older
Creutzberg, CL; van Putten, WLJ; Koper, PC; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van der Steen-Banasik, E; Beerman, H; van Lent, M
Objective. The aim of this study was to determine the rates of local control and survival after relapse in patients with stage I endometrial cancer treated in the multicenter randomized PORTEC trial. Methods, The PORTEC trial included 715 patients with stage I endometrial cancer, either grade I or 2
Greene, Louise Eleanor; Bearn, David R
Randomized clinical trials are considered the 'gold standard' in primary research for healthcare interventions. However, they can be expensive and time-consuming to set up and require many approvals to be in place before they can begin. This paper outlines how to determine what approvals are required for a trial, the background of each approval and the process for obtaining them.
Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara
Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…
Faurschou, A.; Wulf, Hans Chr.
Objective: To examine the effect of topical corticosteroid treatment on acute sunburn. Design: Randomized, double-blind clinical trial. Setting: University dermatology department. Patients: Twenty healthy volunteers with Fitzpatrick skin types I (highly sensitive, always burns easily, tans...... in the acute sunburn reaction when applied 6 or 23 hours after UV exposure. Clinical Trial Registry: clinicaltrials. gov Identifier: NCT00206882 Udgivelsesdato: 2008/5...
Coronado-Montoya, S.; Levis, A.W.; Kwakkenbos, C.M.C.; Steele, R.J.; Turner, E.H.; Thombs, B.D.
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
Santos, Ina S; Bassani, Diego G; Matijasevich, Alicia; Halal, Camila S; Del-Ponte, Bianca; da Cruz, Suélen Henriques; Anselmi, Luciana; Albernaz, Elaine; Fernandes, Michelle; Tovo-Rodrigues, Luciana; Silveira, Mariangela F; Hallal, Pedro C
Sleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants. The study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months. The negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in
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
Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D
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
McKinlay, Sonja; Domanski, Michael J
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5. Randomization: What It Is and How to Do It . . . . . . . . . . . . . . . . . . 27 CATHERINE E. HEWITT AND DAVID J. TORGERSON 6. Setting Sample Size...
Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C; Hobbs, Brian P; Berry, Donald A; Pentz, Rebecca D; Tam, Alda; Hong, Waun K; Ellis, Lee M; Abbruzzese, James; Overman, Michael J
The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P medicine, additional initiatives are needed to minimize selective reporting. © 2015 by American Society of Clinical Oncology.
Kwong, Jeffrey C; Pereira, Jennifer A; Quach, Susan; Pellizzari, Rosana; Dusome, Edwina; Russell, Margaret L; Hamid, Jemila S; Feinberg, Yael; Winter, Anne-Luise; Gubbay, Jonathan B; Sirtonski, Brittany; Moher, Deanna; Sider, Doug; Finkelstein, Michael; Loeb, Mark
School-based influenza immunization can effectively address accessibility barriers, but injected inactivated influenza vaccines (IIV) may not be acceptable to some children and parents in school settings. To better understand the feasibility of offering intranasal live attenuated influenza vaccines (LAIV) through schools, we assessed uptake, stakeholder acceptability, and cost of school-based delivery of LAIV compared to IIV. We piloted an open-label cluster randomized trial involving 10 elementary schools in Peterborough, Ontario during the 2013-2014 influenza vaccination campaign. Schools were randomized to having students receive IIV or LAIV at publicly-funded school-based clinics organized by the local public health department. We measured the percentage of students vaccinated with at least one dose of influenza vaccine at school. Stakeholder acceptability was evaluated through a questionnaire of parents and interviews of public health department personnel and school principals. We compared the costs per dose of vaccine administered, including staff time and costs of vaccines and supplies. Single-dose influenza vaccine uptake was higher for the five schools offering LAIV than for the five offering IIV (19.3% vs. 12.2%, p=0.02). Interviews with nine school principals and five public health department personnel suggested that the clinics ran smoothly with little disruption to school routines, and that LAIV was associated with increased efficiency and calmer children. All interviewees cited unfamiliarity with LAIV and the study recruitment package length as potential reasons for low uptake. The cost per vaccine dose administered was $38.67 for IIV and $43.50 for LAIV. Use of LAIV in school-based clinics was associated with increased vaccine uptake and the perception among immunizing staff of reduced child anxiety, but also slightly higher vaccine administration costs, compared to IIV. However, uptake was low for both groups. More effective strategies to promote
Piepers, Sanne; Veldink, Jan H.; de Jong, Sonja W.; van der Tweel, Ingeborg; van der Pol, W.-Ludo; Uijtendaal, Esther V.; Schelhaas, H. Jurgen; Scheffer, Hans; de Visser, Marianne; de Jong, J. M. B. Vianney; Wokke, John H. J.; Groeneveld, Geert Jan; van den Berg, Leonard H.
Objective: To determine whether valproic acid (VPA), a histone deacetylase inhibitor that showed antioxidative and antiapoptotic properties and reduced glutamate toxicity in preclinical studies, is safe and effective in amyotrophic lateral sclerosis (ALS) using a sequential trial design. Methods:
Full Text Available Abstract Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1 Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group; (2 He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group; (3 Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group. The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36, Self-Rating Anxiety Scale (SAS, and Self-rating Depression Scale (SDS. The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization. Discussion The result of this trial (which will be available in 2012 will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501
Full Text Available De qi is a core concept of acupuncture and is necessary to produce therapeutic effect. In 2010, de qi has been received as a term in the official extension of the CONSORT Statement. However, there are few articles that discuss which factors have influences on obtaining de qi in clinical trials. This paper aims to explore these factors and give advice on trial design in order to optimize de qi in acupuncture RCTs.
Background Neck pain is one of the chief symptoms of cervical spondylosis (CS). Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ) is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ) and The Short Form (36) Health Survey (SF-36) are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA) for primary and secondary outcomes of group and time differences. Adverse events (AEs) will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT) on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the effects of real acupuncture
Full Text Available Abstract Background Neck pain is one of the chief symptoms of cervical spondylosis (CS. Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ and The Short Form (36 Health Survey (SF-36 are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA for primary and secondary outcomes of group and time differences. Adverse events (AEs will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the
Igarashi, Yutaka; Nogami, Yoshie
Background No meta-analysis has examined the effect of regular aquatic exercise on blood pressure. The purpose of this study was to perform a meta-analysis to evaluate the effects of regular aquatic exercise on blood pressure. Design A meta-analysis of randomized controlled trials. Methods Databases were searched for literature published up to April 2017. The randomized controlled trials analysed involved healthy adults, an intervention group that only performed aquatic exercise and a control group that did not exercise, no other intervention, and trials indicated mean systolic blood pressure or diastolic blood pressure. The net change in blood pressure was calculated from each trial, and the changes in blood pressure were pooled by a random effects model, and the risk of heterogeneity was evaluated. Subgroup analysis of subjects with hypertension, subjects who performed endurance exercise (or not), and subjects who only swam (or not) was performed, and the net changes in blood pressure were pooled. Results The meta-analysis examined 14 trials involving 452 subjects. Pooled net changes in blood pressure improved significantly (systolic blood pressure -8.4 mmHg; diastolic blood pressure -3.3 mmHg) and the changes in systolic blood pressure contained significant heterogeneity. When subjects were limited to those with hypertension, those who performed endurance exercise and subjects who did not swim, pooled net changes in systolic and diastolic blood pressure decreased significantly, but the heterogeneity of systolic blood pressure did not improve. Conclusion Like exercise on land, aquatic exercise should have a beneficial effect by lowering blood pressure. In addition, aquatic exercise should lower the blood pressure of subjects with hypertension, and other forms of aquatic exercise besides swimming should also lower blood pressure.
Wesche, M. F.; Tiel-V Buul, M. M.; Lips, P.; Smits, N. J.; Wiersinga, W. M.
A randomized clinical trial was performed in consecutive patients with sporadic nontoxic nodular goiter to compare efficacy and side effects of iodine-131 ((131)I) therapy with suppressive levothyroxine (L-thyroxine) treatment. Sixty-four patients were randomized after stratification for sex and
Watson, Hunna J.; Rees, Clare S.
Objective: To conduct a meta-analysis on randomized, controlled treatment trials of pediatric obsessive-compulsive disorder (OCD). Method: Studies were included if they employed randomized, controlled methodology and treated young people (19 years or under) with OCD. A comprehensive literature search identified 13 RCTs containing 10…
Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.
Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…
Scheltens, P.; Kamphuis, P.J.; Verhey, F.R.J.; Olde Rikkert, M.G.M.; Wurtman, R.J.; Wilkinson, D.; Twisk, J.W.R.; Kurz, A.
OBJECTIVE: To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD). METHODS: A total of 225 drug-naive AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a
Scheltens, P.; Kamphuis, P.J.G.H.; Verhey, F.R.J.; Olde Rikkert, M.G.M.; Wurtman, R.J.; Wilkinson, D.; Twisk, J.W.R.; Kurz, A.
Objective: To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD). Methods: A total of 225 drug-naïve AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a
Muroff, Jordana; Amodeo, Maryann; Larson, Mary Jo; Carey, Margaret; Loftin, Ralph D.
This article describes a data management system (DMS) developed to support a large-scale randomized study of an innovative web-course that was designed to improve substance abuse counselors' knowledge and skills in applying a substance abuse treatment method (i.e., cognitive behavioral therapy; CBT). The randomized trial compared the performance…
Hölmich, P; Larsen, K; Krogsgaard, Kim
programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including...
Campbell, Melissa; Decker, Kathleen P.; Kruk, Kerry; Deaver, Sarah P.
This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans (N = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual…
Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan
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…
Leung, Cynthia; Tsang, Sandra; Ng, Gene S. H.; Choi, S. Y.
Purpose: This study aimed to evaluate the efficacy of Parent-Child Interaction Therapy (PCIT) in Chinese children with attention-deficit/hyperactivity disorder (ADHD) or ADHD features. Methods: This study adopted a randomized controlled trial design without blinding. Participants were randomized into either the intervention group (n = 32) and…
Maartense, Stefan; Dunker, Mich S.; Slors, J. Frederik M.; Cuesta, Miguel A.; Pierik, Erik G. J. M.; Gouma, Dirk J.; Hommes, Daan W.; Sprangers, Miriam A.; Bemelman, Willem A.
OBJECTIVE: The aim of the study was to compare laparoscopic-assisted and open ileocolic resection for primary Crohn's disease in a randomized controlled trial. METHODS: Sixty patients were randomized for laparoscopic-assisted or open surgery. Primary outcome parameter was postoperative quality of
Lang, Ariel J.; Norman, Gregory J.; Casmar, Pollyanna V.
This randomized trial is a first evaluation of a brief psychotherapeutic intervention for primary care patients. Sixty-two participants were randomly assigned to the intervention or to treatment as usual. As compared with treatment as usual, the intervention led to significant reductions in symptoms of anxiety and depression. The reduction was…
Maynard, Brandy R.; Kjellstrand, Elizabeth K.; Thompson, Aaron M.
Objectives: This study examined the effects of Check & Connect (C&C) on the attendance, behavior, and academic outcomes of at-risk youth in a field-based effectiveness trial. Method: A multisite randomized block design was used, wherein 260 primarily Hispanic (89%) and economically disadvantaged (74%) students were randomized to treatment…
Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Massof, Robert W; Leiby, Benjamin E; Ho, Allen C; Tasman, William S
To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD). Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months. Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188). Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire-25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes). At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27-1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27-0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life. An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid depression will increase. Promoting interactions between ophthalmology, optometry
Wahidi, Momen M; Reddy, Chakravarthy; Yarmus, Lonny; Feller-Kopman, David; Musani, Ali; Shepherd, R Wesley; Lee, Hans; Bechara, Rabih; Lamb, Carla; Shofer, Scott; Mahmood, Kamran; Michaud, Gaetane; Puchalski, Jonathan; Rafeq, Samaan; Cattaneo, Stephen M; Mullon, John; Leh, Steven; Mayse, Martin; Thomas, Samantha M; Peterson, Bercedis; Light, Richard W
Patients with malignant pleural effusions have significant dyspnea and shortened life expectancy. Indwelling pleural catheters allow patients to drain pleural fluid at home and can lead to autopleurodesis. The optimal drainage frequency to achieve autopleurodesis and freedom from catheter has not been determined. To determine whether an aggressive daily drainage strategy is superior to the current standard every other day drainage of pleural fluid in achieving autopleurodesis. Patients were randomized to either an aggressive drainage (daily drainage; n = 73) or standard drainage (every other day drainage; n = 76) of pleural fluid via a tunneled pleural catheter. The primary outcome was the incidence of autopleurodesis following the placement of the indwelling pleural catheters. The rate of autopleurodesis, defined as complete or partial response based on symptomatic and radiographic changes, was greater in the aggressive drainage arm than the standard drainage arm (47% vs. 24%, respectively; P = 0.003). Median time to autopleurodesis was shorter in the aggressive arm (54 d; 95% confidence interval, 34-83) as compared with the standard arm (90 d; 95% confidence interval, 70 to nonestimable). Rate of adverse events, quality of life, and patient satisfaction were not significantly different between the two arms. Among patients with malignant pleural effusion, daily drainage of pleural fluid via an indwelling pleural catheter led to a higher rate of autopleurodesis and faster time to liberty from catheter. Clinical trial registered with www.clinicaltrials.gov (NCT 00978939).
Kitahata, Yuji; Kawai, Manabu; Yamaue, Hiroki
Pancreatic fistula is one of severe postoperative complications that occur after pancreatic surgery, such as pancreaticoduodenectomy (PD) and distal pancreatectomy (DP). Because pancreatic fistula is associated with a higher incidence of life-threatening complications. In order to evaluate procedure or postoperative management to reduce pancreatic fistula after pancreatic surgery, we summarized some randomized controlled trials (RCTs) regarding pancreaticoenterostomy during PD, pancreatic duct stent during PD, procedure to resect pancreatic parenchyma during DP, and somatostatin and somatostatin analogues after pancreatic surgery. At first, we reviewed nine RCTs to compare pancreaticogastrostomy (PG) with pancreaticojejunostomy (PJ) during PD. Next, we reviewed five RCTs, to evaluate the impact of pancreatic duct stent during PD. Regarding DP, we reviewed six RCTs to evaluate appropriate procedure to reduce pancreatic fistula after DP. Finally, we reviewed eight RCTs to evaluate the impact of somatostatin and somatostatin analogues after pancreatic surgery to reduce pancreatic fistula. The best way to prevent pancreatic fistula after pancreatic surgery remains still controversial. However, several RCTs clarify a useful procedure to reduce in reducing the incidence of pancreatic fistula after pancreatic surgery. Further RCTs to study innovative approaches remain a high priority for pancreatic surgeons to prevent pancreatic fistula after pancreatic surgery.
McCormick, Frank; Cvetanovich, Gregory L; Kim, Jaehon M; Harris, Joshua D; Gupta, Anil K; Abrams, Geoff D; Romeo, Anthony A; Provencher, Matthew T
The AAOS's Clinical Practice Guideline on "Optimizing Care of Rotator Cuff Problems" suggested a lack of high-quality data. Our purpose is to quantify the quality of randomized controlled trials of rotator cuff disorders via the Jadad score, and to apply the 2010 Consolidated Standards of Reporting Trials CONSORT Criteria to determine factors associated with high Jadad scores and areas for improvement. A systematic review using PRISMA guidelines was performed. Utilizing an iterative search strategy of the top 6 impact factor orthopaedic journals from 2001 to 2011, all randomized controlled studies involving rotator cuff disorders were identified and scored in a systematic, blinded fashion. Each study received a Jadad score. Adherence to CONSORT criteria was quantified and linked to the Jadad score via linear regression. Common deficiencies were described. A total of 129 manuscripts were identified; 54 met inclusion criteria: total patients n = 4099; mean patients per article = 76; range, 16-660. The mean Jadad score was 3.0. Sixty-six percent (35/53) of studies were high quality (high quality: >3). Among these, the majority (63%, 22/35) were nonoperative trials. Adherence to CONSORT Criteria was associated with higher Jadad scores (R(2) = 0.3). The most common deficient CONSORT Criteria were: trial design descriptions (66%; 36/54 studies), descriptions of randomization type (65%; 35/54), and power analysis (46%; 25/54). The majority of randomized controlled trials of rotator cuff pathology are high-quality studies based on the Jadad score. Adherence to CONSORT criteria is linked to high-quality scores. Future studies should use full CONSORT Criteria. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved.
Menahem, Benjamin; Vallois, Antoine; Alves, Arnaud; Lubrano, Jean
The role of prophylactic pelvic drainage in reducing the postoperative complication rate after rectal surgery remains unclear and controversial. This review and meta-analysis of prospective randomized controlled trials was performed to determine whether drainage of the extraperitoneal anastomosis after rectal surgery impacts the postoperative complication rate. Study eligibility criteria included randomized controlled trials comparing prophylactic pelvic drainage after rectal surgery. The Medline and Cochrane Trials Register databases were searched for prospective randomized controlled trials comparing drainage versus no drainage after rectal surgery. Studies published until December 2016 were included. The meta-analysis was performed using Review Manager 5.0 (Cochrane Collaboration, Oxford, UK). Three randomized controlled trials involving 660 patients with extraperitoneal anastomosis after rectal surgery (330 with and 330 without prophylactic pelvic drains) were included. The overall mortality rate was 0.7% (2/267) in the drain group and 1.9% (5/261) in the no-drain group (P = 0.900). The anastomotic leakage rate was 14.8% (49/330) in the drain group and 16.7% (55/330) in the no-drain group (P = 0.370). The postoperative small bowel obstruction rate was significantly higher in the drain than no-drain group (50/267, 18.7% vs. 33/261, 12.6%; odds ratio, 1.61; 95% confidence interval, 1.00-2.60; P = 0.050). Prophylactic use of pelvic drainage after extraperitoneal colorectal anastomosis has no impact on the incidence of anastomotic leakage or postoperative death. However, it significantly increases the rate of postoperative small bowel obstruction.
Kirsti Krohn Garnæs
.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.
Lawton, Julia; White, David; Rankin, David; Elliott, Jackie; Taylor, Carolin; Cooper, Cindy; Heller, Simon; Hallowell, Nina
The ending of a clinical trial may be challenging, particularly if staff are required to withdraw the investigated treatment(s); however, this aspect of trial work is surprisingly under-researched. To address this gap, we explored the experiences of staff involved in closing out a trial that entailed withdrawal of treatment (insulin pumps) from some patients. Interviews were conducted with n = 22 staff, recruited from seven trial sites. Data were analysed thematically. Staff described a myriad of ethical and emotional challenges at closeout, many of which had been unforeseen when the trial began. A key challenge for staff was that, while patients gave their agreement to participate on the understanding that pump treatment could be withdrawn, they often found themselves benefitting from this regimen in ways they could not have foreseen. Hence, as the trial progressed, patients became increasingly anxious about withdrawal of treatment. This situation forced staff to consider whether the consent patients had given at the outset remained valid; it also presented them with a dilemma at closeout because many of those who had wanted to remain on a pump did not meet the clinical criteria required for post-trial funding. When deciding whether to withdraw treatment, staff not only had to take funding pressures and patient distress into account, but they also found themselves caught between an ethic of Hippocratic individualism and one of utilitarianism. These conflicting pressures and ethical considerations resulted in staff decision-making varying across the sites, an issue that some described as a further source of ethical unease. Staff concluded that, had there been more advanced planning and discussion, and greater accountability to an ethics committee, some of the challenges they had confronted at closeout could have been lessened or even prevented. The same kinds of ethical issues that may vex staff at the beginning of a trial (e.g. patients having unrealistic
Wang, Ping; Song, Yuanlin; Liu, Zhi; Wang, Hui; Zheng, Wenke; Liu, Si; Feng, Zhiqiao; Zhai, Jingbo; Yao, Chen; Ren, Ming; Bai, Chunxue; Shang, Hongcai
Severe pneumonia (SP) is a major complication of respiratory system diseases that is associated with high mortality and morbidity. If not treated correctly, it may rapidly lead to sepsis and multiple organ dysfunction syndrome. Despite continuous developments in antibiotic treatments for SP, the mortality rate remains high. Both basic and clinical research show that Xuebijing injection (XBJ) can improve the symptoms of SP. The aim of this study is to evaluate the effectiveness and safety of XBJ compared with placebo. This multicenter, blinded, randomized controlled trial will be conducted with a total of 700 participants with SP. Using a central randomization system, participants will be randomized (1:1) into groups receiving either XBJ or placebo (within 24 h of diagnosis of SP) for 5-7 days with a 28-day follow-up. All participants will receive conventional treatment simultaneously. Both XBJ and placebo will be administered using a photophobic infusion set to avoid bias. The primary outcome is improvement of Pneumonia Severity Index risk rate. Adverse events will be monitored throughout the trial. This is the first and largest randomized trial done in China on SP treatment using a Chinese herbal extract. In this trial, we will use central randomization and an electronic case report form, and we have designed an innovative blinding method for the traditional Chinese medicine injection. The results of this trial may help to provide evidence-based recommendations to clinicians for treatment of SP. Chinese Clinical Trials Registry ChiCTR-TRC-13003534 . Registered 24 June 2013.
Simental-Mendía, Luis E; Simental-Mendía, Mario; Sánchez-García, Adriana; Banach, Maciej; Atkin, Stephen L; Gotto, Antonio M; Sahebkar, Amirhossein
The aim of this meta-analysis of randomized placebo-controlled clinical trials was to assess the effect of fibrates on glycemic parameters. Only randomized placebo-controlled trials investigating the impact of fibrate treatment on glucose homeostasis markers were searched in PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases (from inception to April 11, 2017). A random-effects model and generic inverse variance method were used for quantitative data synthesis. Sensitivity analysis was conducted using the leave-one-out method. A weighted random-effects meta-regression was performed to evaluate the impact of potential confounders on glycemic parameters. This meta-analysis of data from 22 randomized placebo-controlled clinical trials involving a total of 11,402 subjects showed that fibrate therapy significantly decreased fasting plasma glucose (WMD: -0.28 mmol/L, 95% CI: -0.42, -0.14, p effect on HbA1c (WMD: 0.01%, 95% CI: -0.18, 0.19, p = 0.955). All analyses were robust in the leave-one-out sensitivity analysis except for insulin levels that showed a non-significant result (WMD: -0.84 pmol/L, 95% CI: -6.36, 4.68, p = 0.766) following omission of one of the included trials. This meta-analysis has shown that fibrate treatment significantly decreases fasting plasma glucose, insulin levels, and HOMA-IR indicating additional clinical therapeutic benefits. Copyright © 2017 Elsevier Ltd. All rights reserved.
Dugoff, Lorraine; Berghella, Vincenzo; Sehdev, Harish; Mackeen, A Dhanya; Goetzl, Laura; Ludmir, Jack
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.
Miller, R; Bradley, W; Cudkowicz, M; Hubble, J; Meininger, V; Mitsumoto, H; Moore, D; Pohlmann, H; Sauer, D; Silani, V; Strong, M; Swash, M; Vernotica, E
TCH346 exerts antiapoptotic effects by binding to glyceraldehyde 3-phosphate dehydrogenase (GAPDH) and blocking the apoptotic pathway in which GAPDH is involved. Apoptosis is considered to be a key pathogenic mechanism in neurodegenerative diseases including ALS. Patients were randomly assigned in a double-blind fashion to receive either placebo or one of four doses of TCH346 (1.0, 2.5, 7.5, or 15 mg/day) administered orally once daily for at least 24 weeks. The primary outcome measure was the rate of change in the revised ALS functional rating scale (ALSFRS-R). The trial design included a 16-week lead-in phase to determine each patient's rate of disease progression. The between treatment comparison was adjusted for the individual pretreatment rates of progression. The study was powered to detect a 25% reduction in the rate of decline of the ALSFRS-R as compared with placebo. Secondary outcome measures included survival, pulmonary function, and manual muscle testing (MMT). Five hundred ninety-one patients were enrolled at 42 sites in Europe and North America. There were no differences in baseline variables. There were no significant differences between placebo and active treatment groups in the mean rate of decline of the ALSFRS-R or in the secondary outcome measures (survival, pulmonary function, and MMT). The trial revealed no evidence of a beneficial effect of TCH346 on disease progression in patients with ALS.
Gandolfi, Marialuisa; Munari, Daniele; Geroin, Christian; Gajofatto, Alberto; Benedetti, Maria Donata; Midiri, Alessandro; Carla, Fontana; Picelli, Alessandro; Waldner, Andreas; Smania, Nicola
Impaired sensory integration contributes to balance disorders in patients with multiple sclerosis (MS). The objective of this paper is to compare the effects of sensory integration balance training against conventional rehabilitation on balance disorders, the level of balance confidence perceived, quality of life, fatigue, frequency of falls, and sensory integration processing on a large sample of patients with MS. This single-blind, randomized, controlled trial involved 80 outpatients with MS (EDSS: 1.5-6.0) and subjective symptoms of balance disorders. The experimental group (n = 39) received specific training to improve central integration of afferent sensory inputs; the control group (n = 41) received conventional rehabilitation (15 treatment sessions of 50 minutes each). Before, after treatment, and at one month post-treatment, patients were evaluated by a blinded rater using the Berg Balance Scale (BBS), Activities-specific Balance Confidence Scale (ABC), Multiple Sclerosis Quality of Life-54, Fatigue Severity Scale (FSS), number of falls and the Sensory Organization Balance Test (SOT). The experimental training program produced greater improvements than the control group training on the BBS (p integration of afferent sensory inputs may ameliorate balance disorders in patients with MS. Clinical Trial Registration (NCT01040117). © The Author(s), 2015.
Arranz, Sara; Valderas-Martinez, Palmira; Chiva-Blanch, Gemma; Casas, Rosa; Urpi-Sarda, Mireia; Lamuela-Raventos, Rosa M; Estruch, Ramon
Cocoa is an important source of polyphenols, which comprise 12-18% of its total dry weight. The major phenolic compounds in cocoa and cocoa products are mainly flavonoids such as epicatechin, catechin, and proanthocyanidins. These products contain higher amounts of flavonoids than other polyphenol-rich foods. However, the bioavailability of these compounds depends on other food constituents and their interactions with the food matrix. Many epidemiological and clinical intervention trials have concluded that the ingestion of flavonoids reduces the risk factors of developing cardiovascular disease. This review summarizes the new findings regarding the effects of cocoa and chocolate consumption on cardiovascular risk factors. The mechanisms involved in the cardioprotective effects of cocoa flavonoids include reduction of oxidative stress, inhibition of low-density lipoproteins oxidation and platelet aggregation, vasodilatation of blood vessels, inhibition of the adherence of monocytes to vascular endothelium, promotion of fibrinolysis, and immunomodulatory and anti-inflammatory activity. Scientific evidence supports a cause and effect relationship between consumption of cocoa flavonoids and the maintenance of normal endothelium-dependent vasodilation, which contributes to normal blood flow. However, larger randomized trials are required to definitively establish the impact of cocoa and cocoa products consumption on hard cardiovascular outcomes. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.
Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463
Iraji, Fariba; Faghihi, Gita; Siadat, Amir Hossein; Enshaieh, Shahla; Shahmoradi, Zabihlah; Joia, Abolfazl; Soleimani, Fatemeh
Psoriasis is a common disorder affecting 1-3 percent of the general global population. Many therapeutic modalities have been suggested for treatment of this condition, but still there is no definite treatment for this disease. The objective in this study was to evaluate the efficacy of topical azelaic acid gel versus placebo in the treatment of psoriasis vulgaris. This study was a single-blinded randomized clinical trial. Overall, 31 patients were selected and the left or right sided lesions of the patients were randomized to receive either 15% azelaic acid or gel twice daily for a one-month period. Two symmetrical lesions with almost similar severity in every patient were selected and considered as index lesions to evaluate lesion response to treatment. The severity of erythema, scaling, hyperkeratosis and pruritus of the index lesions were scored in range of 0-3 for each lesion by the investigator at the baseline and follow up visits. The percent of involvement of each side of body was also measured using rule of nines. The collected data were analyzed using statistical tests including Mann-Whitney and ANOVA tests. There was no significant difference between the two groups before treatment (P > 0.05). After treatment, however, except pruritus, there was significant difference between the two groups (P 0.05). After treatment, however, there was significant difference between the two groups (P azelaic acid. There was no significant difference regarding percent of body involvement between the two groups before treatment (P > 0.05). After treatment, however, there was a significant difference between the two groups (P azelaic acid gel. The results of our study showed that 15% azelaic acid gel was effective in reduction of purities, scaling and hyperkeratosis of psoriasis plaques. This treatment was also effective in reduction of skin involvement with psoriasis. It is recommended that a longer study be performed that can better evaluate the efficacy of this treatment
Bellinger, David C; Trachtenberg, Felicia; Barregard, Lars; Tavares, Mary; Cernichiari, Elsa; Daniel, David; McKinlay, Sonja
No randomized trials have been published that address the concern that inhalation of mercury vapor released by amalgam dental restorations causes adverse health effects. To compare the neuropsychological and renal function of children whose dental caries were restored using amalgam or mercury-free materials. The New England Children's Amalgam Trial was a 2-group randomized safety trial involving 5 community health dental clinics in Boston, Mass, and 1 in Farmington, Me, between September 1997 and March 2005. A total of 534 children aged 6 to 10 years at baseline with no prior amalgam restorations and 2 or more posterior teeth with caries were randomly assigned to receive dental restoration of baseline and incident caries during a 5-year follow-up period using either amalgam (n=267) or resin composite (n =267) materials. The primary neuropsychological outcome was 5-year change in full-scale IQ scores. Secondary outcomes included tests of memory and visuomotor ability. Renal glomerular function was measured by creatinine-adjusted albumin in urine. Children had a mean of 15 tooth surfaces (median, 14) restored during the 5-year period (range, 0-55). Assignment to the amalgam group was associated with a significantly higher mean urinary mercury level (0.9 vs 0.6 microg/g of creatinine at year 5, Pamalgam and composite groups in 5-year change in full-scale IQ score (3.1 vs 2.1, P = .21). The difference in treatment group change scores was 1.0 (95% confidence interval, -0.6 to 2.5) full-scale IQ score point. No statistically significant differences were found for 4-year change in the general memory index (8.1 vs 7.2, P = .34), 4-year change in visuomotor composite (3.8 vs 3.7, P = .93), or year 5 urinary albumin (median, 7.5 vs 7.4 mg/g of creatinine, P = .61). In this study, there were no statistically significant differences in adverse neuropsychological or renal effects observed over the 5-year period in children whose caries were restored using dental amalgam or
Pagoto, Sherry L; Baker, Katie; Griffith, Julia; Oleski, Jessica L; Palumbo, Ashley; Walkosz, Barbara J; Hillhouse, Joel; Henry, Kimberly L; Buller, David B
Indoor tanning elevates the risk for melanoma, which is now the most common cancer in US women aged 25-29. Public policies restricting access to indoor tanning by minors to reduce melanoma morbidity and mortality in teens are emerging. In the United States, the most common policy restricting indoor tanning in minors involves parents providing either written or in person consent for the minor to purchase a tanning visit. The effectiveness of this policy relies on parents being properly educated about the harms of indoor tanning to their children. This randomized controlled trial will test the efficacy of a Facebook-delivered health communication intervention targeting mothers of teenage girls. The intervention will use health communication and behavioral modification strategies to reduce mothers' permissiveness regarding their teenage daughters' use of indoor tanning relative to an attention-control condition with the ultimate goal of reducing indoor tanning in both daughters and mothers. The study is a 12-month randomized controlled trial comparing 2 conditions: an attention control Facebook private group where content will be relevant to teen health with 25% focused on prescription drug abuse, a topic unrelated to tanning; and the intervention condition will enter participants into a Facebook private group where 25% of the teen health content will be focused on indoor tanning. A cohort of 2000 mother-teen daughter dyads will be recruited to participate in this study. Only mothers will participate in the Facebook groups. Both mothers and daughters will complete measures at baseline, end of intervention (1-year) and 6 months post-intervention. Primary outcomes include mothers' permissiveness regarding their teenage daughters' use of indoor tanning, teenage daughters' perception of their mothers' permissiveness, and indoor tanning by both mothers and daughters. The first dyad was enrolled on March 31, 2016, and we anticipate completing this study by October 2019
Blauw-Hospers, Cornill H; Dirks, Tineke; Hulshof, Lily J; Bos, Arend F; Hadders-Algra, Mijna
Systematic reviews have suggested that early intervention by means of specific motor training programs and general developmental programs in which parents learn how to promote infant development may be the most promising ways to promote infant motor and cognitive development of infants with or at high risk for developmental motor disorders. The purpose of this study was to investigate the effects of a recently developed pediatric physical therapy intervention program ("Coping With and Caring for Infants With Special Needs" [COPCA]) on the development of infants at high risk for developmental disorders using a combined approach of a 2-arm randomized trial and process evaluation. The study was conducted at the University Medical Center Groningen in the Netherlands. Forty-six infants at high risk for developmental disorders were randomly assigned to receive COPCA (a family-centered program) (n=21) or traditional infant physical therapy (TIP) (n=25) between 3 to 6 months corrected age (CA). Developmental outcome was assessed by blinded assessors at 3, 6, and 18 months CA with a neurological examination, the Alberta Infant Motor Scales, the Pediatric Evaluation of Disability Inventory, and the Mental Developmental Index (MDI) of the Bayley Scales of Infant Development. Contents of the intervention were analyzed by a quantitative video analysis of therapy sessions. Quantified physical therapy actions were correlated to evaluate associations between intervention and developmental outcome components. The trial revealed that developmental outcome in both groups was largely identical. Process evaluation showed that typical COPCA actions-(1) family involvement and educational actions, (2) application of a wide variation in challenging the infant to produce motor behavior by himself or herself and allowing the infant to continue this activity, and (3) stimulation of motor behavior at the limit of the infant's capabilities-had positive correlations with developmental outcome at
Geha, Nádia N; Moseley, Anne M; Elkins, Mark R; Chiavegato, Luciana D; Shiwa, Silvia R; Costa, Leonardo O P
While the number of reports of randomized controlled trials in physical therapy has increased substantially in the last decades, the quality and reporting of randomized trials have never been systematically investigated in the subdiscipline of cardiothoracic physical therapy. The primary aim was to determine the methodological quality and completeness of reporting of cardiothoracic physical therapy trials. Secondary aims were to investigate the range of clinical conditions investigated in these trials and the degree of association between trial characteristics and quality. All reports of randomized trials indexed on the Physiotherapy Evidence Database (PEDro) and coded as being relevant to cardiothoracic physical therapy were surveyed. PEDro scale individual items and total score were downloaded, and some characteristics included in the Consolidated Standards of Reporting Trials (CONSORT) statement were extracted for each trial report. The mean ± SD total PEDro score for the 2,970 included reports of cardiothoracic trials was 4.7 ± 1.4, with 27% being of moderate to high quality. The clinical conditions studied included chronic lung diseases (32% of the trials), cardiac diseases (20%), cardiovascular surgical conditions (5%), sleep disorders (5%), peripheral vascular disease (4%), acute lung disease (4%), critical illness (3%), and other surgical conditions (3%). The multivariate linear regression analysis revealed that endorsement of the CONSORT statement by the publishing journal, time since publication, evidence of trial registration, sources of funding, description of the sample size calculation, and identification of the primary outcome(s) had associations with the total PEDro score. There is great potential to improve the quality of the conduct and reporting of trials evaluating the effects of cardiothoracic physical therapy.
Yoshimura, Shinichi; Uchida, Kazutaka; Daimon, Takashi; Takashima, Ryuzo; Kimura, Kazuhiro; Morimoto, Takeshi
Several studies suggested that statins during hospitalization were associated with better disability outcomes in patients with acute ischemic stroke, but only 1 small randomized trial is available. We conducted a multicenter, open-label, randomized controlled trial in patients with acute ischemic strokes in 11 hospitals in Japan. Patients with acute ischemic stroke and dyslipidemia randomly received statins within 24 hours after admission in the early group or on the seventh day in the delayed group, in a 1:1 ratio. Statins were administered for 12 weeks. The primary outcome was patient disability assessed by modified Rankin Scale at 90 days. A total of 257 patients were randomized and analyzed (early 131, delayed 126). At 90 days, modified Rankin Scale score distribution did not differ between groups ( P =0.68), and the adjusted common odds ratio of the early statin group was 0.84 (95% confidence interval, 0.53-1.3; P =0.46) compared with the delayed statin group. There were 3 deaths at 90 days (2 in the early group, 1 in the delayed group) because of malignancy. Ischemic stroke recurred in 9 patients (6.9%) in the early group and 5 patients (4.0%) in the delayed group. The safety profile was similar between groups. Our randomized trial involving patients with acute ischemic stroke and dyslipidemia did not show any superiority of early statin therapy within 24 hours of admission compared with delayed statin therapy 7 days after admission to alleviate the degree of disability at 90 days after onset. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02549846. © 2017 American Heart Association, Inc.
Full Text Available Abstract Background Cellulite is a widespread problem involving females' buttocks and thighs based on the female specific anatomy. Given the higher number of fat cells stored in female fatty tissue in contrast to males, and the aging process of connective tissue leads to an imbalance between lipogenesis and lipolysis with subsequent large fat cells bulging the skin. In addition, microcirculatory changes have been suggested, however remain largely unknown in a controlled clinical setting. We hypothesize that the combination of extracorporeal shockwave and a daily gluteal muscle strength program is superior to the gluteal muscle strength program alone in cellulite. Methods/Design Study design: Randomized-controlled trial. IRB approval was granted at Hannover Medical School, Germany on May 22, 2009. For allocation of participants, a 1:1 ratio randomization was performed using opaque envelopes for the concealment of allocation. Reporting: according to CONSORT 2010. Eligible patients were females aged 18 or over and 65 or younger with cellulite with documented cellulite 1°-4° according to the Nürnberger score. Exclusion criteria were suspected or evident pregnancy, no cellulite, no informed consent or age under 18 years or above 65 years. Patients were recruited by advertisements in local regional newspapers and via the Internet. Analysis: Intention-to-treat. Outcome parameters: a Photonumeric severity scale, b Nürnberger Score, c circumference measurements, d capillary blood flow, e tissue oxygen saturation, f postcapillary venous blood flow. Intervention group: Six sessions of extracorporeal focused shock wave for six sessions (2000 impulses, 0,25 mJ/m2 every 1-2 weeks at both gluteal and thigh regions plus a specific gluteal strength exercise training. Control group: Six sessions of sham extracorporeal focused shock wave for six sessions (2000 impulses, 0,01 mJ/m2 every 1-2 weeks at both gluteal and thigh regions plus a specific gluteal
Babio, Nancy; Toledo, Estefanía; Estruch, Ramón; Ros, Emilio; Martínez-González, Miguel A.; Castañer, Olga; Bulló, Mònica; Corella, Dolores; Arós, Fernando; Gómez-Gracia, Enrique; Ruiz-Gutiérrez, Valentina; Fiol, Miquel; Lapetra, José; Lamuela-Raventos, Rosa M.; Serra-Majem, Lluís; Pintó, Xavier; Basora, Josep; Sorlí, José V.; Salas-Salvadó, Jordi
Background: Little evidence exists on the effect of an energy-unrestricted healthy diet on metabolic syndrome. We evaluated the long-term effect of Mediterranean diets ad libitum on the incidence or reversion of metabolic syndrome. Methods: We performed a secondary analysis of the PREDIMED trial — a multicentre, randomized trial done between October 2003 and December 2010 that involved men and women (age 55–80 yr) at high risk for cardiovascular disease. Participants were randomly assigned to 1 of 3 dietary interventions: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with nuts or advice on following a low-fat diet (the control group). The interventions did not include increased physical activity or weight loss as a goal. We analyzed available data from 5801 participants. We determined the effect of diet on incidence and reversion of metabolic syndrome using Cox regression analysis to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). Results: Over 4.8 years of follow-up, metabolic syndrome developed in 960 (50.0%) of the 1919 participants who did not have the condition at baseline. The risk of developing metabolic syndrome did not differ between participants assigned to the control diet and those assigned to either of the Mediterranean diets (control v. olive oil HR 1.10, 95% CI 0.94–1.30, p = 0.231; control v. nuts HR 1.08, 95% CI 0.92–1.27, p = 0.3). Reversion occurred in 958 (28.2%) of the 3392 participants who had metabolic syndrome at baseline. Compared with the control group, participants on either Mediterranean diet were more likely to undergo reversion (control v. olive oil HR 1.35, 95% CI 1.15–1.58, p < 0.001; control v. nuts HR 1.28, 95% CI 1.08–1.51, p < 0.001). Participants in the group receiving olive oil supplementation showed significant decreases in both central obesity and high fasting glucose (p = 0.02); participants in the group supplemented with nuts showed a
Pérez-Mármol, Jose Manuel; García-Ríos, M Carmen; Barrero-Hernandez, Francisco J; Molina-Torres, Guadalupe; Brown, Ted; Aguilar-Ferrándiz, María Encarnación
Upper limb apraxia is a common disorder associated with stroke that can reduce patients' independence levels in activities of daily living and increase levels of disability. Traditional rehabilitation programs designed to promote the recovery of upper limb function have mainly focused on restorative or compensatory approaches. However, no previous studies have been completed that evaluate a combined intervention method approach, where patients concurrently receive cognitive training and learn compensatory strategies for enhancing daily living activities. This study will use a two-arm, assessor-blinded, parallel, randomized controlled trial design, involving 40 patients who present a left- or right-sided unilateral vascular lesion poststroke and a clinical diagnosis of upper limb apraxia. Participants will be randomized to either a combined functional rehabilitation or a traditional health education group. The experimental group will receive an 8-week combined functional program at home, including physical and occupational therapy focused on restorative and compensatory techniques for upper limb apraxia, 3 days per week in 30-min intervention periods. The control group will receive a conventional health education program once a month over 8 weeks, based on improving awareness of physical and functional limitations and facilitating the adaptation of patients to the home. Study outcomes will be assessed immediately postintervention and at the 2-month follow-up. The primary outcome measure will be basic activities of daily living skills as assessed with the Barthel Index. Secondary outcome measures will include the following: 1) the Lawton and Brody Instrumental Activities of Daily Living Scale, 2) the Observation and Scoring of ADL-Activities, 3) the De Renzi Test for Ideational Apraxia, 4) the De Renzi Test for Ideomotor Apraxia, 5) Recognition of Gestures, 6) the Test of Upper Limb Apraxia (TULIA), and 7) the Quality of Life Scale For Stroke (ECVI-38). This trial is
Background Cellulite is a widespread problem involving females' buttocks and thighs based on the female specific anatomy. Given the higher number of fat cells stored in female fatty tissue in contrast to males, and the aging process of connective tissue leads to an imbalance between lipogenesis and lipolysis with subsequent large fat cells bulging the skin. In addition, microcirculatory changes have been suggested, however remain largely unknown in a controlled clinical setting. We hypothesize that the combination of extracorporeal shockwave and a daily gluteal muscle strength program is superior to the gluteal muscle strength program alone in cellulite. Methods/Design Study design: Randomized-controlled trial. IRB approval was granted at Hannover Medical School, Germany on May 22, 2009. For allocation of participants, a 1:1 ratio randomization was performed using opaque envelopes for the concealment of allocation. Reporting: according to CONSORT 2010. Eligible patients were females aged 18 or over and 65 or younger with cellulite with documented cellulite 1°-4° according to the Nürnberger score. Exclusion criteria were suspected or evident pregnancy, no cellulite, no informed consent or age under 18 years or above 65 years. Patients were recruited by advertisements in local regional newspapers and via the Internet. Analysis: Intention-to-treat. Outcome parameters: a) Photonumeric severity scale, b) Nürnberger Score, c) circumference measurements, d) capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow. Intervention group: Six sessions of extracorporeal focused shock wave for six sessions (2000 impulses, 0,25 mJ/m2 every 1-2 weeks) at both gluteal and thigh regions plus a specific gluteal strength exercise training. Control group: Six sessions of sham extracorporeal focused shock wave for six sessions (2000 impulses, 0,01 mJ/m2 every 1-2 weeks) at both gluteal and thigh regions plus a specific gluteal strength exercise training
Abigail T Evans
Full Text Available Observational research suggests that placing graphic images on cigarette warning labels can reduce smoking rates, but field studies lack experimental control. Our primary objective was to determine the psychological processes set in motion by naturalistic exposure to graphic vs. text-only warnings in a randomized clinical trial involving exposure to modified cigarette packs over a 4-week period. Theories of graphic-warning impact were tested by examining affect toward smoking, credibility of warning information, risk perceptions, quit intentions, warning label memory, and smoking risk knowledge.Adults who smoked between 5 and 40 cigarettes daily (N = 293; mean age = 33.7, did not have a contra-indicated medical condition, and did not intend to quit were recruited from Philadelphia, PA and Columbus, OH. Smokers were randomly assigned to receive their own brand of cigarettes for four weeks in one of three warning conditions: text only, graphic images plus text, or graphic images with elaborated text.Data from 244 participants who completed the trial were analyzed in structural-equation models. The presence of graphic images (compared to text-only caused more negative affect toward smoking, a process that indirectly influenced risk perceptions and quit intentions (e.g., image->negative affect->risk perception->quit intention. Negative affect from graphic images also enhanced warning credibility including through increased scrutiny of the warnings, a process that also indirectly affected risk perceptions and quit intentions (e.g., image->negative affect->risk scrutiny->warning credibility->risk perception->quit intention. Unexpectedly, elaborated text reduced warning credibility. Finally, graphic warnings increased warning-information recall and indirectly increased smoking-risk knowledge at the end of the trial and one month later.In the first naturalistic clinical trial conducted, graphic warning labels are more effective than text-only warnings
Pettigrew, Simone; Jongenelis, Michelle; Newton, Robert U; Warburton, Jeni; Jackson, Ben
A growing evidence base demonstrates that interventions that focus on participation in physical and social activities can assist in preventing and treating both physical and mental health problems. In addition, there is some evidence that engaging in volunteering activities can provide beneficial social, physical, psychological, and cognitive outcomes for older people. This study will use a randomized controlled trial approach to investigate the potential for interventions involving volunteer activities to produce positive physical and psychological outcomes for older people, thereby contributing to the limited evidence relating to the potential for volunteering to provide multiple health effects. This randomized controlled trial will involve 400 retired/non-employed individuals in good health aged 60+ years living in the metropolitan area in Perth, Western Australia. Participants will be recruited from the Perth metropolitan area using a variety of recruitment methods to achieve a diverse sample in terms of age, gender, and socioeconomic status. Consenting and eligible participants will be randomly assigned to an intervention (n = 200) or control group (n = 200). Those in the intervention group will be asked to engage in a minimum 60 min of volunteer activities per week for a period of 6 months, while those in the control group will be asked to maintain their existing lifestyle or take on new activities as they see fit. Physical and psychological outcomes will be assessed. Primary physical outcomes will include physical activity and sedentary time (measured using pedometers and Actigraph monitors) and physical health (measured using a battery of physical functioning tests, resting heart rate, blood pressure, BMI, and girth). Primary psychological outcomes will include psychological well-being, depression, self-esteem, and quality of life (measured using the Warwick-Edinburgh Mental Well-Being Scale, Center for Epidemiologic Studies Depression Scale, the
Susukida, Ryoko; Crum, Rosa M; Ebnesajjad, Cyrus; Stuart, Elizabeth A; Mojtabai, Ramin
To compare randomized controlled trial (RCT) sample treatment effects with the population effects of substance use disorder (SUD) treatment. Statistical weighting was used to re-compute the effects from 10 RCTs such that the participants in the trials had characteristics that resembled those of patients in the target populations. Multi-site RCTs and usual SUD treatment settings in the United States. A total of 3592 patients in 10 RCTs and 1 602 226 patients from usual SUD treatment settings between 2001 and 2009. Three outcomes of SUD treatment were examined: retention, urine toxicology and abstinence. We weighted the RCT sample treatment effects using propensity scores representing the conditional probability of participating in RCTs. Weighting the samples changed the significance of estimated sample treatment effects. Most commonly, positive effects of trials became statistically non-significant after weighting (three trials for retention and urine toxicology and one trial for abstinence); also, non-significant effects became significantly positive (one trial for abstinence) and significantly negative effects became non-significant (two trials for abstinence). There was suggestive evidence of treatment effect heterogeneity in subgroups that are under- or over-represented in the trials, some of which were consistent with the differences in average treatment effects between weighted and unweighted results. The findings of randomized controlled trials (RCTs) for substance use disorder treatment do not appear to be directly generalizable to target populations when the RCT samples do not reflect adequately the target populations and there is treatment effect heterogeneity across patient subgroups. © 2017 Society for the Study of Addiction.
Kearney, Anna; Williamson, Paula; Young, Bridget; Bagley, Heather; Gamble, Carrol; Denegri, Simon; Muir, Delia; Simon, Natalie A; Thomas, Stephen; Elliot, Jim T; Bulbeck, Helen; Crocker, Joanna C; Planner, Claire; Vale, Claire; Clarke, Mike; Sprosen, Tim; Woolfall, Kerry
Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. A modified Delphi process including a two round online survey and a stakeholder consensus meeting. In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.