A meta-analysis of mammographic screening with and without clinical breast examination

PubMed Central

Hamashima, Chisato; Ohta, Koji; Kasahara, Yoshio; Katayama, Takafumi; Nakayama, Tomio; Honjo, Satoshi; Ohnuki, Koji

2015-01-01

Mammographic screening with clinical breast examination has been recommended in Japan since 2000. Although mammographic screening without clinical breast examination has not been recommended, its introduction is anticipated. The efficacies of mammographic screening with and without clinical breast examination were evaluated based on the results of randomized controlled trials. PubMed and other databases for studies published between 1985 and 2014 were searched. The study design was limited to randomized controlled trials to evaluate mortality reduction from breast cancer. Five studies were eligible for meta-analysis of mammographic screening without clinical breast examination. The relative risk for women aged 40–74 years was 0.75 (95% confidence interval, 0.67–0.83). Three studies evaluated the efficacy of mammographic screening with clinical breast examination. The relative risk for women aged 40–64 years was 0.87 (95% confidence interval, 0.77–0.98). The number needed to invite was always lower in mammographic screening without clinical breast examination than in mammographic screening with clinical breast examination. In both screening methods, the number needed to invite was higher in women aged 40–49 years than in women aged 50–70 years. These results suggest that mammographic screening without clinical breast examination can afford higher benefits to women aged 50 years and over. Although evidence of the efficacy of mammographic screening without clinical breast examination was confirmed based on the results of the randomized controlled trials, a Japanese study is needed to resolve local problems. PMID:25959787

A Multicenter, Randomized Clinical Trial of a Cognitive Remediation Program for Childhood Survivors of a Pediatric Malignancy

ERIC Educational Resources Information Center

Butler, Robert W.; Copeland, Donna R.; Fairclough, Diane L.; Mulhern, Raymond K.; Katz, Ernest R.; Kazak, Anne E.; Noll, Robert B.; Patel, Sunita K.; Sahler, Olle Jane Z.

2008-01-01

Survivors of childhood cancer whose malignancy and/or treatment involved the central nervous system may demonstrate a consistent pattern of neurocognitive deficits. The present study evaluated a randomized clinical trial of the Cognitive Remediation Program (CRP). Participants were 6- to 17-year-old survivors of childhood cancer (N = 161; 35%…

Reducing Sexual Risk Behaviors and Alcohol Use among HIV-Positive Men Who Have Sex with Men: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Velasquez, Mary M.; von Sternberg, Kirk; Johnson, David H.; Green, Charles; Carbonari, Joseph P.; Parsons, Jeffrey T.

2009-01-01

This randomized clinical trial (N = 253) evaluated the efficacy of a theory-based intervention designed to reduce both alcohol use and incidence of unprotected sexual behaviors among HIV-positive men who have sex with men with alcohol use disorders. An integrated, manualized intervention, using both individual counseling and peer group…

A Parent-Mediated Intervention that Targets Responsive Parental Behaviors Increases Attachment Behaviors in Children with ASD: Results from a Randomized Clinical Trial

ERIC Educational Resources Information Center

Siller, Michael; Swanson, Meghan; Gerber, Alan; Hutman, Ted; Sigman, Marian

2014-01-01

The current study is a randomized clinical trial evaluating the efficacy of Focused Playtime Intervention (FPI) in a sample of 70 children with Autism Spectrum Disorder. This parent-mediated intervention has previously been shown to significantly increase responsive parental communication (Siller et al. in "J Autism Dev Disord"…

Lack of adjunctive benefit of Er:YAG laser in non-surgical periodontal treatment: a randomized split-mouth clinical trial.

PubMed

Rotundo, Roberto; Nieri, Michele; Cairo, Francesco; Franceschi, Debora; Mervelt, Jana; Bonaccini, Daniele; Esposito, Marco; Pini-Prato, Giovanpaolo

2010-06-01

This split-mouth, randomized, clinical trial aimed to evaluate the efficacy of erbium-doped:yttrium-aluminium-garnet (Er:YAG) laser application in non-surgical periodontal treatment. A total of 27 patients underwent four modalities of non-surgical therapy: supragingival debridement; scaling and root planing (SRP)+Er:YAG laser; Er:YAG laser; and SRP. Each strategy was randomly assigned and performed in one of the four quadrants. Clinical outcomes were evaluated at 3 and 6 months. Subjective benefits of patients have been evaluated by means of questionnaires. Six months after therapy, Er:YAG laser showed no statistical difference in clinical attachment gain with respect to supragingival scaling [0.15 mm (95% CI -0.16; 0.46)], while SRP showed a greater attachment gain than the supragingival scaling [0.37 mm (95% CI 0.05; 0.68)]. No difference resulted between Er:YAG laser+SRP and SRP alone [0.05 mm (95% CI -0.25; 0.36)]. The adjunctive use of Er:YAG laser to conventional SRP did not reveal a more effective result than SRP alone. Furthermore, the sites treated with Er:YAG laser showed similar results of the sites treated with supragingival scaling.

Randomized pilot study and qualitative evaluation of a clinical decision support system for brain tumour diagnosis based on SV ¹H MRS: evaluation as an additional information procedure for novice radiologists.

PubMed

Sáez, Carlos; Martí-Bonmatí, Luis; Alberich-Bayarri, Angel; Robles, Montserrat; García-Gómez, Juan M

2014-02-01

The results of a randomized pilot study and qualitative evaluation of the clinical decision support system Curiam BT are reported. We evaluated the system's feasibility and potential value as a radiological information procedure complementary to magnetic resonance (MR) imaging to assist novice radiologists in diagnosing brain tumours using MR spectroscopy (1.5 and 3.0T). Fifty-five cases were analysed at three hospitals according to four non-exclusive diagnostic questions. Our results show that Curiam BT improved the diagnostic accuracy in all the four questions. Additionally, we discuss the findings of the users' feedback about the system, and the further work to optimize it for real environments and to conduct a large clinical trial. © 2013 Published by Elsevier Ltd.

Clinical competence of Guatemalan and Mexican physicians for family dysfunction management.

PubMed

Cabrera-Pivaral, Carlos Enrique; Orozco-Valerio, María de Jesús; Celis-de la Rosa, Alfredo; Covarrubias-Bermúdez, María de Los Ángeles; Zavala-González, Marco Antonio

2017-01-01

To evaluate the clinical competence of Mexican and Guatemalan physicians to management the family dysfunction. Cross comparative study in four care units first in Guadalajara, Mexico, and four in Guatemala, Guatemala, based on a purposeful sampling, involving 117 and 100 physicians, respectively. Clinical competence evaluated by validated instrument integrated for 187 items. Non-parametric descriptive and inferential statistical analysis was performed. The percentage of Mexican physicians with high clinical competence was 13.7%, medium 53%, low 24.8% and defined by random 8.5%. For the Guatemalan physicians'14% was high, average 63%, and 23% defined by random. There were no statistically significant differences between healthcare country units, but between the medium of Mexicans (0.55) and Guatemalans (0.55) (p = 0.02). The proportion of the high clinical competency of Mexican physicians' was as Guatemalans.

A random walk model for evaluating clinical trials involving serial observations.

PubMed

Hopper, J L; Young, G P

1988-05-01

For clinical trials where the variable of interest is ordered and categorical (for example, disease severity, symptom scale), and where measurements are taken at intervals, it might be possible to achieve a greater discrimination between the efficacy of treatments by modelling each patient's progress as a stochastic process. The random walk is a simple, easily interpreted model that can be fitted by maximum likelihood using a maximization routine with inference based on standard likelihood theory. In general the model can allow for randomly censored data, incorporates measured prognostic factors, and inference is conditional on the (possibly non-random) allocation of patients. Tests of fit and of model assumptions are proposed, and application to two therapeutic trials of gastroenterological disorders are presented. The model gave measures of the rate of, and variability in, improvement for patients under different treatments. A small simulation study suggested that the model is more powerful than considering the difference between initial and final scores, even when applied to data generated by a mechanism other than the random walk model assumed in the analysis. It thus provides a useful additional statistical method for evaluating clinical trials.

The case for randomized controlled trials to assess the impact of clinical information systems.

PubMed

Liu, Joseph L Y; Wyatt, Jeremy C

2011-01-01

There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit.

The case for randomized controlled trials to assess the impact of clinical information systems

PubMed Central

Wyatt, Jeremy C

2011-01-01

There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit. PMID:21270132

Careless and Random Responding on Clinical and Research Measures in the Addictions: A Concerning Problem and Investigation of Their Detection

ERIC Educational Resources Information Center

Meyer, Joseph F.; Faust, Kyle A.; Faust, David; Baker, Aaron M.; Cook, Nathan E.

2013-01-01

Even when relatively infrequent, careless and random responding (C/RR) can have robust effects on individual and group data and thereby distort clinical evaluations and research outcomes. Given such potential adverse impacts and the broad use of self-report measures when appraising addictions and addictive behavior, the detection of C/RR can…

Decision analysis to complete diagnostic research by closing the gap between test characteristics and cost-effectiveness.

PubMed

Schaafsma, Joanna D; van der Graaf, Yolanda; Rinkel, Gabriel J E; Buskens, Erik

2009-12-01

The lack of a standard methodology in diagnostic research impedes adequate evaluation before implementation of constantly developing diagnostic techniques. We discuss the methodology of diagnostic research and underscore the relevance of decision analysis in the process of evaluation of diagnostic tests. Overview and conceptual discussion. Diagnostic research requires a stepwise approach comprising assessment of test characteristics followed by evaluation of added value, clinical outcome, and cost-effectiveness. These multiple goals are generally incompatible with a randomized design. Decision-analytic models provide an important alternative through integration of the best available evidence. Thus, critical assessment of clinical value and efficient use of resources can be achieved. Decision-analytic models should be considered part of the standard methodology in diagnostic research. They can serve as a valid alternative to diagnostic randomized clinical trials (RCTs).

A Prospective, Randomized, Double-blind, Split-face Clinical Trial Comparing the Efficacy of Two Topical Human Growth Factors for the Rejuvenation of the Aging Face

PubMed Central

Goldman, Mitchel P.

2017-01-01

Background: Cosmeceutical products represent an increasingly important therapeutic option for anti-aging and rejuvenation, either used alone or in combination with dermatologic surgical procedures. Among this group of products, topical growth factors have demonstrated efficacy in randomized, controlled clinical trials. However, comparisons between different products remain uncommon. Objective: The objective of this randomized, double-blind, split-face clinical trial was to compare two different topical growth factor formulations derived from either human fibroblasts or human adipose tissue derived mesenchymal stem cells. Methods: This was an institutional review board-approved, randomized, double-blind, split-face clinical trial involving 20 healthy subjects with moderate-to-severe facial wrinkling secondary to photodamage. One half of the face was randomized to receive topical human fibroblast growth factors and the other topical human mesenchymal stem cell growth factors. Treatment was continued for three months, and evaluations were performed in a double-blind fashion. Results: Both growth factor formulations achieved significant improvement in facial wrinkling. Blinded investigator and subject evaluations did not detect any significant differences between the two formulations in terms of efficacy, safety, or tolerability. Conclusion: Both human fibroblast growth factors and human mesenchymal stem cell growth factors are effective at facial rejuvenation. Topical growth factors represent a useful therapeutic modality. PMID:28670356

A Prospective, Randomized, Double-blind, Split-face Clinical Trial Comparing the Efficacy of Two Topical Human Growth Factors for the Rejuvenation of the Aging Face.

PubMed

Wu, Douglas C; Goldman, Mitchel P

2017-05-01

Background: Cosmeceutical products represent an increasingly important therapeutic option for anti-aging and rejuvenation, either used alone or in combination with dermatologic surgical procedures. Among this group of products, topical growth factors have demonstrated efficacy in randomized, controlled clinical trials. However, comparisons between different products remain uncommon. Objective: The objective of this randomized, double-blind, split-face clinical trial was to compare two different topical growth factor formulations derived from either human fibroblasts or human adipose tissue derived mesenchymal stem cells. Methods: This was an institutional review board-approved, randomized, double-blind, split-face clinical trial involving 20 healthy subjects with moderate-to-severe facial wrinkling secondary to photodamage. One half of the face was randomized to receive topical human fibroblast growth factors and the other topical human mesenchymal stem cell growth factors. Treatment was continued for three months, and evaluations were performed in a double-blind fashion. Results: Both growth factor formulations achieved significant improvement in facial wrinkling. Blinded investigator and subject evaluations did not detect any significant differences between the two formulations in terms of efficacy, safety, or tolerability. Conclusion: Both human fibroblast growth factors and human mesenchymal stem cell growth factors are effective at facial rejuvenation. Topical growth factors represent a useful therapeutic modality.

Can Group Interventions Facilitate Forgiveness of an Ex-Spouse?: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Rye, Mark S.; Pargament, Kenneth I.; Pan, Wei; Yingling, David W.; Shogren, Karrie A.; Ito, Masako

2005-01-01

This study evaluated the effectiveness of 2 versions of an 8-session forgiveness group intervention for divorced individuals. Participants (randomized, n = 192; analyzed, n = 149) were randomly assigned to a secular forgiveness condition, a religious forgiveness condition, or a no-intervention comparison condition. Measures of forgiveness and…

Outcome Evaluation of "Family Eats": An Eight-Session Web-Based Program Promoting Healthy Home Food Environments and Dietary Behaviors for African American Families

ERIC Educational Resources Information Center

Cullen, Karen Weber; Thompson, Debbe; Chen, Tzu-An

2017-01-01

This article presents the results of a randomized clinical trial evaluating the eight-session "Family Eats" web-based intervention promoting healthy home food environments for African American families. African American families (n = 126) with 8- to 12-year-old children completed online baseline questionnaires and were randomized into…

A unified procedure for meta-analytic evaluation of surrogate end points in randomized clinical trials

PubMed Central

Dai, James Y.; Hughes, James P.

2012-01-01

The meta-analytic approach to evaluating surrogate end points assesses the predictiveness of treatment effect on the surrogate toward treatment effect on the clinical end point based on multiple clinical trials. Definition and estimation of the correlation of treatment effects were developed in linear mixed models and later extended to binary or failure time outcomes on a case-by-case basis. In a general regression setting that covers nonnormal outcomes, we discuss in this paper several metrics that are useful in the meta-analytic evaluation of surrogacy. We propose a unified 3-step procedure to assess these metrics in settings with binary end points, time-to-event outcomes, or repeated measures. First, the joint distribution of estimated treatment effects is ascertained by an estimating equation approach; second, the restricted maximum likelihood method is used to estimate the means and the variance components of the random treatment effects; finally, confidence intervals are constructed by a parametric bootstrap procedure. The proposed method is evaluated by simulations and applications to 2 clinical trials. PMID:22394448

Evaluating online continuing medical education seminars: evidence for improving clinical practices.

PubMed

Weston, Christine M; Sciamanna, Christopher N; Nash, David B

2008-01-01

The purpose of this study was to evaluate the potential for online continuing medical education (CME) seminars to improve quality of care. Primary care physicians (113) participated in a randomized controlled trial to evaluate an online CME series. Physicians were randomized to view either a seminar about type 2 diabetes or a seminar about systolic heart failure. Following the seminar, physicians were presented with 4 clinical vignettes and asked to describe what tests, treatments, counseling, or referrals they would recommend. Physicians who viewed the seminars were significantly more likely to recommend guideline-consistent care to patients in the vignettes. For example, physicians who viewed the diabetes seminar were significantly more likely to order an eye exam for diabetes patients (63%) compared with physicians in the control group (27%). For some guidelines there were no group differences. These results provide early evidence of the effectiveness of online CME programs to improve physician clinical practice.

Randomized trial of harp therapy during in vitro fertilization-embryo transfer.

PubMed

Murphy, Erin M; Nichols, Jennifer; Somkuti, Steve G; Sobel, Michael; Braverman, Andrea; Barmat, Larry I

2014-04-01

This study evaluated whether harp therapy reduces levels of stress and improves clinical outcomes in patients undergoing embryo transfer. This prospective randomized trial enrolled 181 women undergoing embryo transfer, who were randomized to harp therapy during embryo transfer or standard treatment. Patients underwent standardized psychological testing and physiologic assessment of stress. The study was conducted in a reproductive medicine practice. No statistically significant differences were found in the heart and respiratory rates, nor was there a significant difference in event-based anxiety at baseline. Harp therapy had a significantly larger decrease in state anxiety from pre- to post-embryo transfer. Clinical pregnancy was 53% versus 48% for the harp therapy and standard treatment groups, respectively. Harp therapy decreases state, or event-based, anxiety, significantly lowering state scores posttransfer and having a positive effect on acute levels of stress. There was an increased pregnancy rate, but larger sample sizes are needed to evaluate whether harp therapy has an effect on clinical outcomes.

Effect of UV irradiation on cutaneous cicatrices: a randomized, controlled trial with clinical, skin reflectance, histological, immunohistochemical and biochemical evaluations.

PubMed

Due, Eva; Rossen, Kristian; Sorensen, Lars Tue; Kliem, Anette; Karlsmark, Tonny; Haedersdal, Merete

2007-01-01

The aim of this study was to examine the effect of ultraviolet (UV) irradiation on human cutaneous cicatrices. In this randomized, controlled study, dermal punch biopsy wounds served as a wound healing model. Wounds healed by primary or second intention and were randomized to postoperative solar UV irradiation or to no UV exposure. Evaluations after 5 and 12 weeks included blinded clinical assessments, skin reflectance measurements, histology, immunohistochemistry, and biochemical analyses of the N-terminal propeptide from procollagen-1, hydroxyproline, hydroxylysine, and proline. Twelve weeks postoperatively, UV-irradiated cicatrices healing by second intention: (i) were significantly pointed out as the most disfiguring; (ii) obtained significantly higher scores of colour, infiltration and cicatrix area; and (iii) showed significantly higher increase in skin-reflectance measurements of skin-pigmentation vs. non-irradiated cicatrices. No histological, immunohistochemical or biochemical differences were found. In conclusion, postoperative UV exposure aggravates the clinical appearance of cicatrices in humans.

[Realization of design regarding experimental research in the clinical real-world research].

PubMed

He, Q; Shi, J P

2018-04-10

Real world study (RWS), a further verification and supplement for explanatory randomized controlled trial to evaluate the effectiveness of intervention measures in real clinical environment, has increasingly become the focus in the field of research on medical and health care services. However, some people mistakenly equate real world study with observational research, and argue that intervention and randomization cannot be carried out in real world study. In fact, both observational and experimental design are the basic designs in real world study, while the latter usually refers to pragmatic randomized controlled trial and registry-based randomized controlled trial. Other nonrandomized controlled and adaptive designs can also be adopted in the RWS.

Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study).

PubMed

McNally, Dayre; Amrein, Karin; O'Hearn, Katharine; Fergusson, Dean; Geier, Pavel; Henderson, Matt; Khamessan, Ali; Lawson, Margaret L; McIntyre, Lauralyn; Redpath, Stephanie; Weiler, Hope A; Menon, Kusum

2017-01-01

Clinical research has recently demonstrated that vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (PICU) and associated with worse clinical course. Multiple adult ICU trials have suggested that optimization of vitamin D status through high-dose supplementation may reduce mortality and improve other clinically relevant outcomes; however, there have been no trials of rapid normalization in the PICU setting. The objective of this study is to evaluate the safety and efficacy of an enteral weight-based cholecalciferol loading dose regimen in critically ill children with VDD. The VITdAL-PICU pilot study is designed as a multicenter placebo-controlled phase II dose evaluation pilot randomized controlled trial. We aim to randomize 67 VDD critically ill children using a 2:1 randomization schema to receive loading dose enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or a placebo solution. Participants, caregivers and outcome assessors will be blinded to allocation. Eligibility criteria include ICU patient, aged 37 weeks to 18 years, expected ICU length of stay more than 48 h, anticipated access to bloodwork at 7 days, and VDD (blood total 25 hydroxyvitamin D < 50 nmol/L). The primary objective is to determine whether the dosing protocol normalizes vitamin D status, defined as a blood total 25(OH)D concentration above 75 nmol/L. Secondary objectives include an examination of the safety of the dosing regimen (e.g. hypercalcemia, hypercalciuria, nephrocalcinosis), measures of vitamin D axis function (e.g. calcitriol levels, immune function), and protocol feasibility (eligibility criteria, protocol deviations, blinding). Despite significant observational literature suggesting VDD to be a modifiable risk factor in the PICU setting, there is no robust clinical trial evidence evaluating the benefits of rapid normalization. This phase II clinical trial will evaluate an innovative weight-based dosing regimen intended to rapidly and safely normalize vitamin D levels in critically ill children. Study findings will be used to inform the design of a multicenter phase III trial evaluating the clinical and economic benefits to rapid normalization. Recruitment for this trial was initiated in January 2016 and is expected to continue until November 30, 2017. Clinicaltrials.gov NCT02452762.

Cost-effectiveness of health research study participant recruitment strategies: a systematic review.

PubMed

Huynh, Lynn; Johns, Benjamin; Liu, Su-Hsun; Vedula, S Swaroop; Li, Tianjing; Puhan, Milo A

2014-10-01

A large fraction of the cost of conducting clinical trials is allocated to recruitment of participants. A synthesis of findings from studies that evaluate the cost and effectiveness of different recruitment strategies will inform investigators in designing cost-efficient clinical trials. To systematically identify, assess, and synthesize evidence from published comparisons of the cost and yield of strategies for recruitment of participants to health research studies. We included randomized studies in which two or more strategies for recruitment of participants had been compared. We focused our economic evaluation on studies that randomized participants to different recruitment strategies. We identified 10 randomized studies that compared recruitment strategies, including monetary incentives (cash or prize), direct contact (letters or telephone call), and medical referral strategies. Only two of the 10 studies compared strategies for recruiting participants to clinical trials. We found that allocating additional resources to recruit participants using monetary incentives or direct contact yielded between 4% and 23% additional participants compared to using neither strategy. For medical referral, recruitment of prostate cancer patients by nurses was cost-saving compared to recruitment by consultant urologists. For all underlying study designs, monetary incentives cost more than direct contact with potential participants, with a median incremental cost per recruitment ratio of Int$72 (Int$-International dollar, a theoretical unit of currency) for monetary incentive strategy compared to Int$28 for direct contact strategy. Only monetary incentives and source of referral were evaluated for recruiting participants into clinical trials. We did not review studies that presented non-monetary cost or lost opportunity cost. We did not adjust for the number of study recruitment sites or the study duration in our economic evaluation analysis. Systematic and explicit reporting of cost and effectiveness of recruitment strategies from randomized comparisons is required to aid investigators to select cost-efficient strategies for recruiting participants to health research studies including clinical trials. © The Author(s) 2014.

The application of disease management to clinical trial designs.

PubMed

Puterman, Jared; Alter, David A

2009-08-01

The utilization of disease management (DM) as a minimum standard of care is believed to facilitate pronounced benefits in overall patient outcome and cost management. Randomized clinical trials remain the gold standard evaluative tool in clinical medicine. However, the extent to which contemporary cardiovascular clinical trials incorporate DM components into their treatment or control arms is unknown. Our study is the first to evaluate the extent to which clinical trials incorporate DM as a minimum standard of care for both the intervention and control groups. In total, 386 clinical trials published in 3 leading medical journals between 2003 and 2006 were evaluated. For each study, elements related to DM care, as defined using the American Heart Association Taxonomy, were abstracted and characterized. Our results demonstrate that while the application of DM has increased over time, only 3.4% of the clinical trials examined incorporated all 8 DM elements (and only 11% of such trials incorporated 4 DM elements). A significant association was found between study year and the inclusion of more than 3 elements of DM (chi(2) = 10.10 (3); p = 0.018). In addition, associations were found between study objective and DM criteria, as well as between cohort type and domains described. Our study serves as a baseline reference for the tracking of DM within, and its application to, randomized clinical trials. Moreover, our results underscore the need for broader implementation and evaluation of DM as a minimum care standard within clinical trial research.

Orthodontic treatment in periodontitis‐susceptible subjects: a systematic literature review

PubMed Central

Lindsten, Rune; Slotte, Christer; Bjerklin, Krister

2016-01-01

Abstract The aim is to evaluate the literature for clinical scientific data on possible effects of orthodontic treatment on periodontal status in periodontitis‐susceptible subjects. A systematic literature review was performed on studies in English using PubMed, MEDLINE, and Cochrane Library central databases (1965‐2014). By manually searching reference lists of selected studies, we identified additional articles; then we searched these publications: Journal of Periodontology, Periodontology 2000, Journal of Clinical Periodontology, American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, International Journal of Periodontics & Restorative Dentistry, and European Journal of Orthodontics. Search terms included randomized clinical trials, controlled clinical trials, prospective and retrospective clinical studies, case series >5 patients, periodontitis, orthodontics, alveolar bone loss, tooth migration, tooth movement, orthodontic extrusion, and orthodontic intrusion. Only studies on orthodontic treatment in periodontally compromised dentitions were included. One randomized controlled clinical trial, one controlled clinical trial, and 12 clinical studies were included. No evidence currently exists from controlled studies and randomized controlled clinical trials, which shows that orthodontic treatment improves or aggravates the status of periodontally compromised dentitions. PMID:29744163

Safety and efficacy of injectable and oral maropitant, a selective neurokinin 1 receptor antagonist, in a randomized clinical trial for treatment of vomiting in dogs.

PubMed

Ramsey, D S; Kincaid, K; Watkins, J A; Boucher, J F; Conder, G A; Eagleson, J S; Clemence, R G

2008-12-01

Maropitant (Cerenia), a selective neurokinin(1) receptor antagonist, was evaluated for safety and efficacy in treatment and prevention of acute vomiting due to various etiologies in dogs in a randomized clinical trial. Two-hundred seventy-eight dogs were enrolled from 29 veterinary hospitals. Two-hundred fifty-two were evaluable for efficacy, while 275 were evaluable for safety. A randomized block design was utilized (three maropitant- and one placebo-treated dog per block). Initial treatment was maropitant at 1 mg/kg body weight (0.45 mg/lb) or an equivalent volume of saline (placebo) administered subcutaneously. On the subsequent 1 to 4 days, maropitant or placebo (dependent on allocation) was administered subcutaneously or orally at approximate 24-h intervals as needed. Oral doses were administered as maropitant tablets using unit dosing to deliver a minimum dose of 2 mg/kg body weight (0.9 mg/lb) or equivalent numbers of similar placebo tablets. Dogs and housing were observed twice daily for evidence of vomiting. Emesis was significantly (P

Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial.

PubMed

Yotebieng, Marcel; Behets, Frieda; Kawende, Bienvenu; Ravelomanana, Noro Lantoniaina Rosa; Tabala, Martine; Okitolonda, Emile W

2017-04-26

Despite the rapid adoption of the World Health Organization's 2013 guidelines, children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health (MCH) clinics. To achieve the UNAIDS goal of eliminating mother-to-child HIV transmission, multiple, adaptive interventions need to be implemented to improve adherence to the HIV continuum. The aim of this open label, parallel, group randomized trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district levels to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo. Prior to randomization, the current monitoring and evaluation system will be strengthened to enable collection of high quality individual patient-level data necessary for timely indicators production and program outcomes monitoring to inform CQI interventions. Following randomization, in health districts randomized to CQI, quality improvement (QI) teams will be established at the district level and at MCH clinics level. For 18 months, QI teams will be brought together quarterly to identify key bottlenecks in the care delivery system using data from the monitoring system, develop an action plan to address those bottlenecks, and implement the action plan at the level of their district or clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in resource-scarce settings to accelerate progress towards the goal of an AIDS free generation. The protocol was retrospectively registered on February 7, 2017. ClinicalTrials.gov Identifier: NCT03048669 .

Applicability of randomized trials in radiation oncology to standard clinical practice.

PubMed

Apisarnthanarax, Smith; Swisher-McClure, Samuel; Chiu, Wing K; Kimple, Randall J; Harris, Stephen L; Morris, David E; Tepper, Joel E

2013-08-15

Randomized controlled trials (RCTs) are commonly used to inform clinical practice; however, it is unclear how generalizable RCT data are to patients in routine clinical practice. The authors of this report assessed the availability and applicability of randomized evidence guiding medical decisions in a cohort of patients who were evaluated for consideration of definitive management in a radiation oncology clinic. The medical records of consecutive, new patient consultations between January and March 2007 were reviewed. Patient medical decisions were classified as those with (Group 1) or without (Group 2) available, relevant level I evidence (phase 3 RCT) supporting recommended treatments. Group 1 medical decisions were further divided into 3 groups based on the extent of fulfilling eligibility criteria for each RCT: Group 1A included decisions that fulfilled all eligibility criteria; Group 1B, decisions that did not fulfill at least 1 minor eligibility criteria; or Group 1C, decisions that did not fulfill at least 1 major eligibility criteria. Patient and clinical characteristics were tested for correlations with the availability of evidence. Of the 393 evaluable patients, malignancies of the breast (30%), head and neck (18%), and genitourinary system (14%) were the most common presenting primary disease sites. Forty-seven percent of all medical decisions (n = 451) were made without available (36%) or applicable (11%) randomized evidence to inform clinical decision making. Primary tumor diagnosis was significantly associated with the availability of evidence (P < .0001). A significant proportion of medical decisions in an academic radiation oncology clinic were made without available or applicable level I evidence, underscoring the limitations of relying solely on RCTs for the development of evidence-based health care. Copyright © 2013 American Cancer Society.

Evaluation of Four Pulpotomy Techniques in Primary Molars: A Randomized Controlled Trial

PubMed Central

Ansari, Ghassem; Morovati, Seyyedeh Pouya; Asgary, Saeed

2018-01-01

Introduction: This trial was designed to evaluate the clinical and radiographic success rates of calcium-enriched mixture (CEM) cement with and without low level laser therapy (LLLT) and compare them to that of formocresol (FC) and ferric sulfate (FS) in primary molar pulpotomies. Methods and Materials: This randomized clinical trial was conducted on a total of 160 teeth selected from 40 patients aged 3-9 years. Patients with at least four primary molars needing pulpotomy, were included in order to have each tooth assigned randomly in one of the four following groups; FC, FS, CEM, and LLLT/CEM. Six- and twelve-month follow-up periods were conducted in order to enable a clinical and radiographic evaluation of the treated teeth. Collected data were analyzed using Cochran Q Tests. Results: The 12-month clinical success rate for each technique was: FC=100%, FS=95%, CEM=97.5% and LLLT/CEM=100% with no significant differences (P>0.05). Furthermore, 12-month radiographic success rate for each technique was: FC=100%, FS=92.5%, CEM=95% and LLLT/CEM=100% with no significant differences (P>0.05). Conclusion: Favorable outcomes of four treatment techniques in pulpotomy of primary molar teeth were comparable. CEM with/without LLLT may be considered as a safe and successful pulpotomy treatment modality compared to current conventional methods. PMID:29692828

Pulsed Nd:YAG laser selective ablation of surface enamel caries: II. Histology and clinical trials

NASA Astrophysics Data System (ADS)

Harris, David M.; Goodis, Harold E.; White, Joel M.; Arcoria, Charles J.; Simon, James; Burkart, John; Yessik, Michael J.; Myers, Terry D.

2000-03-01

High intensity infrared light from the pulsed Nd:YAG dental laser is absorbed by pigmented carious enamel and not absorbed by normal enamel. Therefore, this system is capable of selective removal of surface enamel caries. Safety and efficacy of the clinical procedure was evaluated in two sets of clinical trials at three dental schools. Carious lesions were randomized to drill or laser treatment. Pulp vitality, surface condition, preparations and restorations were evaluated by blinded evaluators. In Study 1 surface caries were removed from 104 third molars scheduled for extraction. One week post-treatment teeth were extracted and the pulp was examined histologically. In Study 2 90 patients with 422 lesions on 376 teeth were randomized to laser or drill and followed for six months. There were no adverse events and both clinical and histological evaluations of pulp vitality showed no abnormalities. Caries were removed in all conditions. A significantly greater number of preparations in the drill groups vs. laser groups entered dentin (drill equals 11, laser equals 1, p less than 0.001). This indicates that the more conservative laser treatment removed the caries but not the sound enamel below the lesion.

Systematic Review of Economic Evaluations of Units Dedicated to Acute Coronary Syndromes.

PubMed

Azeredo-Da-Silva, André Luis Ferreira; Perini, Silvana; Rigotti Soares, Pedro Henrique; Polaczyk, Carisi Anne

2016-01-01

Dedicated units for the care of acute coronary syndrome (ACS) have been submitted to economic evaluations; however, the results have not been systematically presented. To identify and summarize economic outcomes of studies on hospital units dedicated to the initial care of patients with suspected or confirmed ACS. A systematic review of literature to identify economic evaluations of chest pain unit (CPU), coronary care unit (CCU), or equivalent units was done. Two search strategies were used: the first one to identify economic evaluations irrespective of study design, and the second one to identify randomized clinical trials that reported economic outcomes. The following databases were searched: MEDLINE, EMBASE, CENTRAL, and National Health Service (NHS)Economic Evaluation Database. Data extraction was performed by two independent reviewers. Costs were inflated to 2012 values. Search strategies retrieved five partial economic evaluations based on observational studies, six randomized clinical trials that reported economic outcomes, and five model-based economic evaluations. Overall, cost estimates based on observational studies and randomized clinical trials reported statistically significant cost savings of more than 50% with the adoption of CPU care instead of routine hospitalization or CCU care for suspected low-to-intermediate risk patients with ACS (median per-patient cost US $1,969.89; range US $1,002.12-13,799.15). Model-based economic evaluations reported incremental cost-effectiveness ratios below US $ 50,000/quality-adjusted life-year for all comparisons between intermediate care unit, CPU, or CCU with routine hospital admissions. This finding was sensible to myocardial infarction probability. Published economic evaluations indicate that more intensive care is likely to be cost-effective in comparison to routine hospital admission for patients with suspected ACS. Copyright © 2016. Published by Elsevier Inc.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

Smartphone app design for the wireless control of a neuromuscular electrical stimulator device with integrated randomization allocation process for RCT applications.

PubMed

Sweeney, Dean; Quinlan, Leo R; OLaighin, Gearoid

2015-08-01

The use of NMES has evolved over the last five decades. Technological advancements have transformed these once complex systems into user-friendly devices with enhanced control functions, leading to new applications of NMES being investigated. The use of Randomized Control Trial (RCT) methodology in evaluating the effectiveness of new and existing applications of NMES is a demanding process adding time and cost to a translation into clinical practice. Poor quality trials may result in poor evidence of NMES effectiveness. In this paper some of the key challenges encountered in NMES clinical trials are identified with the aim of purposing a solution to address these challenges through the adoption of Smartphone technology. The design and evaluation of a smartphone application to provide automatic blind randomization control and facilitating the wireless temporal control of a portable Bluetooth enabled NMES is presented.

[Evidence-based quality assessment of 10-year orthodontic clinical trials in 4 major dental journals].

PubMed

Sun, Yan-nan; Lei, Fei-fei; Cao, Yan-li; Fu, Min-kui

2010-02-01

To assess the quality of orthodontic clinical trials published in 4 major dental journals in the past 10 years and establish the reference standard for orthodontic clinical trials and quality control of dental journals. All the clinical trials published in Chinese Journal of Stomatology, West China Journal of Stomatology, Journal of Practice Stomatology and Chinese Journal of Orthodontics from 1999 to 2008 were searched. The demographic information of the papers was extracted and the quality of the clinical trials according to the consolidated standards of reporting trials (CONSORT) was assessed. Four hundred and ninety-four clinical trials were retrieved, and 21.3% (105/494) of them were supported by grants. For the study design, only 26.1% (129/494) were prospective studies, and 3.8% (19/494) were randomized clinical trials. It was hard to evaluate precisely due to the lack of information about the details of the study designs. For the randomized clinical trials, the lack of details for randomization, allocation concealment, blinding and intention to treat compromised the quality. The general quality of clinical trials in orthodontics is poor. It needs to be improved both in the clinical study design and the paper writing.

Millon Clinical Multiaxial Inventory-III Subtypes of Opioid Dependence: Validity and Matching to Behavioral Therapies

ERIC Educational Resources Information Center

Ball, Samuel A.; Nich, Charla; Rounsaville, Bruce J.; Eagan, Dorothy; Carroll, Kathleen M.

2004-01-01

The concurrent and predictive validity of 2 different methods of Millon Clinical Multiaxial Inventory-III subtyping (protocol sorting, cluster analysis) was evaluated in 125 recently detoxified opioid-dependent outpatients in a 12-week randomized clinical trial. Participants received naltrexone and relapse prevention group counseling and were…

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. II. Features of and lessons from the follow-up investigations].

PubMed

Jermendy, György

2018-04-01

Although the outcomes of the follow-up investigation period of the randomized clinical studies for evaluating the efficacy of a treatment or an antidiabetic drug may be confounded or potentially biased by several factors, the results are widely accepted by the diabetes community. In line with the theory of metabolic memory or metabolic legacy, early and intensive antihyperglycaemic treatment should be provided for all diabetic patients as this strategy can result in beneficial effects even in the long run. The recent cardiovascular safety trials with new, innovative antidiabetic drugs differ in several aspects from the former efficacy studies. Ten cardiovascular safety trials were completed so far enabling to define their unique and common features. It can be anticipated that the era of randomized, controlled efficacy studies with observational follow-up investigations came to an end in diabetes research. Nowadays, cardiovascular safety trials are in the focus of clinical research in diabetology and results of several ongoing studies are expected with interest in the near future. Orv Hetil. 2018; 159(16): 615-619.

Evaluating hospital discharge planning: a randomized clinical trial.

PubMed

Evans, R L; Hendricks, R D

1993-04-01

To select patients for early discharge planning, a randomized clinical trial evaluated a protocol that used risk factors identified upon hospital admission. The goal of the study was to determine if intervention with high-risk patients could reduce the need for hospital admission or skilled care. Of 13,255 patients screened, 835 study participants were identified as "at risk" for frequent health care resource use. Half of the high-risk patients were randomly assigned to the experimental group (n = 417) and received discharge planning from day 3 of their hospital stay, while the control group (n = 418) received discharge planning only if there was a written physician request. Those patients receiving early, systematic discharge planning experienced an increased likelihood of successful return to home after hospital admission and a decreased chance of unscheduled readmission for the 9-month study period. Length of the index hospital stay was not affected by early planning, however. The major clinical implication is the potential for discharge planners to decrease the need for, and use of, health care resources after hospital admission.

[Parodontocid efficiency in complex treatment and prevention of gingivitis].

PubMed

Makeeva, I M; Turkina, A Iu; Poliakova, M A; Babina, K S

2013-01-01

Antiplaque/antigingivitis effect of an alcohol-free mouthrinse Parodontocid were evaluated by randomized parallel group clinical trial. Sixty patients with gingivitis were clinically examined to determine PHP, RMNPI and PMA indexes. After professional dental prophylaxis, subjects were randomly assigned in two groups to 10 days oral hygiene program. Group 1 patients used only toothbrush and prophylactic toothpaste while in group 2 persons used Parodontocid in conjunction with normal brushing and flossing.Parodontocid significantly reduced plaque and gingivitis compared to negative control.

Permissive or Trophic Enteral Nutrition and Full Enteral Nutrition Had Similar Effects on Clinical Outcomes in Intensive Care: A Systematic Review of Randomized Clinical Trials.

PubMed

Silva, Camila F A; de Vasconcelos, Simone G; da Silva, Thales A; Silva, Flávia M

2018-01-26

The aim of this study was to systematically review the effect of permissive underfeeding/trophic feeding on the clinical outcomes of critically ill patients. A systematic review of randomized clinical trials to evaluate the mortality, length of stay, and mechanical ventilation duration in patients randomized to either hypocaloric or full-energy enteral nutrition was performed. Data sources included PubMed and Scopus and the reference lists of the articles retrieved. Two independent reviewers participated in all phases of this systematic review as proposed by the Cochrane Handbook, and the review was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 7 randomized clinical trials that included a total of 1,717 patients were reviewed. Intensive care unit length of stay and mechanical ventilation duration were not statistically different between the intervention and control groups in all randomized clinical trials, and mortality rate was also not different between the groups. In conclusion, hypocaloric enteral nutrition had no significantly different effects on morbidity and mortality in critically ill patients when compared with full-energy nutrition. It is still necessary to determine the safety of this intervention in this group of patients, the optimal amount of energy provided, and the duration of this therapy. © 2018 American Society for Parenteral and Enteral Nutrition.

Acellular dermal matrix allograft versus free gingival graft: a histological evaluation and split-mouth randomized clinical trial.

PubMed

de Resende, Daniel Romeu Benchimol; Greghi, Sebastião Luiz Aguiar; Siqueira, Aline Franco; Benfatti, César Augusto Magalhães; Damante, Carla Andreotti; Ragghianti Zangrando, Mariana Schutzer

2018-04-30

This split-mouth controlled randomized clinical trial evaluated clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG) for keratinized tissue augmentation. Twenty-five patients with the absence or deficiency of keratinized tissue (50 sites) were treated with FGG (control group) and ADM (test group). Clinical parameters included keratinized tissue width (KTW) (primary outcome), soft tissue thickness (TT), recession depth (RD), probing depth (PD), and clinical attachment level (CAL). Esthetic perception was evaluated by patients and by a calibrated periodontist using visual analog scale (VAS). Histological analysis included biopsies of five different patients from both test and control sites for each evaluation period (n = 25). The analysis included percentage of connective tissue components, epithelial luminal to basal surface ratio, tissue maturation, and presence of elastic fibers. Data were evaluated by ANOVA complemented by Tukey's tests (p < 0.05). After 6 months, PD and CAL demonstrated no differences between groups. ADM presented higher RD compared to FGG in all periods. Mean tissue shrinkage for control and test groups was 12.41 versus 55.7%. TT was inferior for ADM group compared to FGG. Esthetics perception by professional evaluation showed superior results for ADM. Histomorphometric analysis demonstrated higher percentage of cellularity, blood vessels, and epithelial luminal to basal surface ratio for FGG group. ADM group presented higher percentage of collagen fibers and inflammatory infiltrate. Both treatments resulted in improvement of clinical parameters, except for RD. ADM group presented more tissue shrinkage and delayed healing, confirmed histologically, but superior professional esthetic perception. This study added important clinical and histological data to contribute in the decision-making process between indication of FGG or ADM.

Cost-Effectiveness of Primary Care Management With or Without Early Physical Therapy for Acute Low Back Pain: Economic Evaluation of a Randomized Clinical Trial.

PubMed

Fritz, Julie M; Kim, Minchul; Magel, John S; Asche, Carl V

2017-03-01

Economic evaluation of a randomized clinical trial. Compare costs and cost-effectiveness of usual primary care management for patients with acute low back pain (LBP) with or without the addition of early physical therapy. Low back pain is among the most common and costly conditions encountered in primary care. Early physical therapy after a new primary care consultation for acute LBP results in small clinical improvement but cost-effectiveness of a strategy of early physical therapy is unknown. Economic evaluation was conducted alongside a randomized clinical trial of patients with acute, nonspecific LBP consulting a primary care provider. All patients received usual primary care management and education, and were randomly assigned to receive four sessions of physical therapy or usual care of delaying referral consideration to permit spontaneous recovery. Data were collected in a randomized trial involving 220 participants age 18 to 60 with LBP <16 days duration without red flags or signs of nerve root compression. The EuroQoL EQ-5D health states were collected at baseline and after 1-year and used to compute the quality adjusted life year (QALY) gained. Direct (health care utilization) and indirect (work absence or reduced productivity) costs related to LBP were collected monthly and valued using standard costs. The incremental cost-effectiveness ratio was computed as incremental total costs divided by incremental QALYs. Early physical therapy resulted in higher total 1-year costs (mean difference in adjusted total costs = $580, 95% CI: $175, $984, P = 0.005) and better quality of life (mean difference in QALYs = 0.02, 95% CI: 0.005, 0.35, P = 0.008) after 1-year. The incremental cost-effectiveness ratio was $32,058 (95% CI: $10,629, $151,161) per QALY. Our results support early physical therapy as cost-effective relative to usual primary care after 1 year for patients with acute, nonspecific LBP. 2.

[Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].

PubMed

Xie, Yanming; Wei, Xu

2011-10-01

Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.

Effects of a Brief Multimedia Psychoeducational Intervention on the Attitudes and Interest of Patients With Cancer Regarding Clinical Trial Participation: A Multicenter Randomized Controlled Trial

PubMed Central

Jacobsen, Paul B.; Wells, Kristen J.; Meade, Cathy D.; Quinn, Gwendolyn P.; Lee, Ji-Hyun; Fulp, William J.; Gray, Jhanelle E.; Baz, Rachid C.; Springett, Gregory M.; Levine, Richard M.; Markham, Merry-Jennifer; Schreiber, Fred J.; Cartwright, Thomas H.; Burke, James M.; Siegel, Robert D.; Malafa, Mokenge P.; Sullivan, Daniel

2012-01-01

Purpose The negative attitudes of patients with cancer regarding clinical trials are an important contributor to low participation rates. This study evaluated whether a brief psychoeducational intervention was effective in improving patients' attitudes as well as their knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials. Patients and Methods A total of 472 adults with cancer who had not been asked previously to participate in a clinical trial were randomly assigned to receive printed educational information about clinical trials or a psychoeducational intervention that provided similar information and also addressed misperceptions and concerns about clinical trials. The primary (attitudes) and secondary outcomes (knowledge, self-efficacy, receptivity, and willingness) were assessed via patient self-report before random assignment and 7 to 28 days later. Results Patients who received the psychoeducational intervention showed more positive attitudes toward clinical trials (P = .016) and greater willingness to participate (P = .011) at follow-up than patients who received printed educational information. Evidence of an indirect effect of intervention assignment on willingness to participate (estimated at 0.168; 95% CI, 0.088 to 0.248) suggested that the benefits of psychoeducation on willingness to participate were explained by the positive impact of psychoeducation on attitudes toward clinical trials. Conclusion A brief psychoeducational intervention can improve the attitudes of patients with cancer toward clinical trials and thereby increase their willingness to participate in clinical trials. Findings support conducting additional research to evaluate effects of this intervention on quality of decision making and rates of participation among patients asked to enroll onto therapeutic clinical trials. PMID:22614993

Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness.

PubMed

Zhao, Wenle; Weng, Yanqiu; Wu, Qi; Palesch, Yuko

2012-01-01

To evaluate the performance of randomization designs under various parameter settings and trial sample sizes, and identify optimal designs with respect to both treatment imbalance and allocation randomness, we evaluate 260 design scenarios from 14 randomization designs under 15 sample sizes range from 10 to 300, using three measures for imbalance and three measures for randomness. The maximum absolute imbalance and the correct guess (CG) probability are selected to assess the trade-off performance of each randomization design. As measured by the maximum absolute imbalance and the CG probability, we found that performances of the 14 randomization designs are located in a closed region with the upper boundary (worst case) given by Efron's biased coin design (BCD) and the lower boundary (best case) from the Soares and Wu's big stick design (BSD). Designs close to the lower boundary provide a smaller imbalance and a higher randomness than designs close to the upper boundary. Our research suggested that optimization of randomization design is possible based on quantified evaluation of imbalance and randomness. Based on the maximum imbalance and CG probability, the BSD, Chen's biased coin design with imbalance tolerance method, and Chen's Ehrenfest urn design perform better than popularly used permuted block design, EBCD, and Wei's urn design. Copyright © 2011 John Wiley & Sons, Ltd.

Kericho CLinic-based ART Diagnostic Evaluation (CLADE): design, accrual, and baseline characteristics of a randomized controlled trial conducted in predominately rural, district-level, HIV clinics of Kenya.

PubMed

Sawe, Fredrick K; Obiero, Eunice; Yegon, Peter; Langat, Rither C; Aoko, Appolonia; Tarus, Jemutai; Kiptoo, Ignatius; Langat, Raphael K; Maswai, Jonah; Bii, Margaret; Khamadi, Samoel; Shikuku, Kibet P; Close, Nicole; Sinei, Samuel; Shaffer, Douglas N

2015-01-01

Prospective clinical trial data regarding routine HIV-1 viral load (VL) monitoring of antiretroviral therapy (ART) in non-research clinics of Sub-Saharan Africa are needed for policy makers. CLinic-based ART Diagnostic Evaluation (CLADE) is a randomized, controlled trial (RCT) evaluating feasibility, superiority, and cost-effectiveness of routine VL vs. standard of care (clinical and immunological) monitoring in adults initiating dual nucleoside reverse transcriptase inhibitor (NRTI)+non-NRTI ART. Participants were randomized (1:1) at 7 predominately rural, non-research, district-level clinics of western Kenya. Descriptive statistics present accrual patterns and baseline cohort characteristics. Over 15 months, 820 adults enrolled at 7 sites with 86-152 enrolled per site. Monthly site enrollment ranged from 2-92 participants. Full (100%) informed consent compliance was independently documented. Half (49.9%) had HIV diagnosed through voluntary counseling and testing. Study arms were similar: mostly females (57.6%) aged 37.6 (SD = 9.0) years with low CD4 (166 [SD = 106]) cells/m3). Notable proportions had WHO Stage III or IV disease (28.7%), BMI <18.5 kg/m2 (23.1%), and a history of tuberculosis (5.6%) or were receiving tuberculosis treatment (8.2%) at ART initiation. In the routine VL arm, 407/409 (99.5%) received baseline VL (234,577 SD = 151,055 copies/ml). All participants received lamivudine; 49.8% started zidovudine followed by 38.4% stavudine and 11.8% tenofovir; and, 64.4% received nevirapine as nNRTI (35.6% efavirenz). A RCT can be enrolled successfully in rural, non-research, resource limited, district-level clinics in western Kenya. Many adults presenting for ART have advanced HIV/AIDS, emphasizing the importance of universal HIV testing and linkage-to-care campaigns. ClinicalTrials.gov NCT01791556.

Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.

PubMed

2008-09-01

The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial was undertaken to determine whether early revascularization intervention is superior to deferred intervention in the presence of aggressive medical therapy and whether antidiabetes regimens targeting insulin sensitivity are more or less effective than regimens targeting insulin provision in reducing cardiovascular events among patients with type 2 diabetes mellitus and stable coronary artery disease (CAD). The BARI 2D trial is a National Institutes of Health-sponsored randomized clinical trial with a 2 x 2 factorial design. Between 2001 and 2005, 49 clinical sites in North America, South America, and Europe randomized 2,368 patients. At baseline, the trial collected data on clinical history, symptoms, and medications along with centralized evaluations of angiograms, electrocardiograms, and blood and urine specimens. Most of the BARI 2D patients were referred from the cardiac catheterization laboratory (54%) or cardiology clinic (27%). Of the randomized participants, 30% were women, 34% were minorities, 61% had angina, and 67% had multiregion CAD. Moreover, 29% had been treated with insulin, 58% had hemoglobin A(1c) >7.0%, 41% had low-density lipoprotein cholesterol >or=100 mg/dL, 52% had blood pressure >130/80 mm Hg, and 56% had body mass index >or=30 kg/m(2). Baseline characteristics in BARI 2D are well balanced between the randomized treatment groups, and the clinical profile of the study cohort is representative of the target population. As a result, the BARI 2D clinical trial is in an excellent position to evaluate alternative treatment approaches for diabetes and CAD.

Tobacco dependence counseling in a randomized multisite clinical trial

PubMed Central

Croghan, Ivana T.; Trautman, Judith A.; Winhusen, Theresa; Ebbert, Jon O.; Kropp, Frankie; Schroeder, Darrell R.; Hurt, Richard D.

2012-01-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a “train-the-trainer” model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3 ± 2.8 sessions (mean ± SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and “meeting expectations” on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. PMID:22406192

Tobacco dependence counseling in a randomized multisite clinical trial.

PubMed

Croghan, Ivana T; Trautman, Judith A; Winhusen, Theresa; Ebbert, Jon O; Kropp, Frankie B; Schroeder, Darrell R; Hurt, Richard D

2012-07-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3±2.8 sessions (mean±SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and "meeting expectations" on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. Copyright © 2012 Elsevier Inc. All rights reserved.

Personalized Mailed Feedback for College Drinking Prevention: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Larimer, Mary E.; Lee, Christine M.; Kilmer, Jason R.; Fabiano, Patricia M.; Stark, Christopher B.; Geisner, Irene M.; Mallett, Kimberly A.; Lostutter, Ty W.; Cronce, Jessica M.; Feeney, Maggie; Neighbors, Clayton

2007-01-01

The current study was designed to evaluate the efficacy of a mailed feedback and tips intervention as a universal prevention strategy for college drinking. Participants (N = 1,488) were randomly assigned to feedback or assessment-only control conditions. Results indicated that the mailed feedback intervention had a preventive effect on drinking…

Evaluating a Brief, Video-Based Sexual Risk Reduction Intervention and Assessment Reactivity with STI Clinic Patients: Results from a Randomized Controlled Trial

PubMed Central

Carey, Michael P.; Senn, Theresa E.; Walsh, Jennifer L.; Coury-Doniger, Patricia; Urban, Marguerite A.; Fortune, Thierry; Vanable, Peter A.; Carey, Kate B.

2014-01-01

We report results from a randomized controlled trial designed to evaluate the efficacy of a video-based sexual risk reduction intervention and to measure assessment reactivity. Patients (N = 1010; 56 % male; 69 % African American) receiving care at a sexually transmitted infection (STI) clinic were assigned to one of four conditions formed by crossing assessment condition (i.e., sexual health vs. general health) with intervention condition (i.e., sexual risk reduction intervention vs. general health promotion). After completing their assigned baseline assessment, participants received their assigned intervention, and subsequently returned for follow-up assessments at 3, 6, 9, and 12 months. Participants in all conditions reduced their self-reported sexual risk behavior, and the incidence of new STIs declined from baseline through the follow-ups; however, there was no effect of intervention or assessment condition. We conclude that further risk reduction will require more intensive interventions, especially in STI clinics that already provide excellent clinical care. PMID:25433653

A Randomized Trial of a Hepatitis Care Coordination Model in Methadone Maintenance Treatment

PubMed Central

Delucchi, Kevin L.; McKnight, Courtney; Hettema, Jennifer; Khalili, Mandana; Min, Albert; Jordan, Ashly E.; Pepper, Nicole; Hall, Jessica; Hengl, Nicholas S.; Young, Christopher; Shopshire, Michael S.; Manuel, Jennifer K.; Coffin, Lara; Hammer, Hali; Shapiro, Bradley; Seewald, Randy M.; Bodenheimer, Henry C.; Sorensen, James L.; Des Jarlais, Don C.; Perlman, David C.

2013-01-01

Objectives. We evaluated the efficacy of a hepatitis care coordination intervention to improve linkage to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination and clinical evaluation of hepatitis C virus (HCV) infection among methadone maintenance patients. Methods. We conducted a randomized controlled trial of 489 participants from methadone maintenance treatment programs in San Francisco, California, and New York City from February 2008 through June 2011. We randomized participants to a control arm (n = 245) and an intervention arm (n = 244), which included on-site screening, motivational-enhanced education and counseling, on-site vaccination, and case management services. Results. Compared with the control group, intervention group participants were significantly more likely (odds ratio [OR] = 41.8; 95% confidence interval [CI] = 19.4, 90.0) to receive their first vaccine dose within 30 days and to receive an HCV evaluation within 6 months (OR = 4.10; 95% CI = 2.35, 7.17). A combined intervention adherence outcome that measured adherence to HAV–HBV vaccination, HCV evaluation, or both strongly favored the intervention group (OR = 8.70; 95% CI = 5.56, 13.61). Conclusions. Hepatitis care coordination was efficacious in increasing adherence to HAV–HBV vaccination and HCV clinical evaluation among methadone patients. PMID:23947319

Randomized clinical trial of encapsulated and hand-mixed glass-ionomer ART restorations: one-year follow-up.

PubMed

Freitas, Maria Cristina Carvalho de Almendra; Fagundes, Ticiane Cestari; Modena, Karin Cristina da Silva; Cardia, Guilherme Saintive; Navarro, Maria Fidela de Lima

2018-01-18

This prospective, randomized, split-mouth clinical trial evaluated the clinical performance of conventional glass ionomer cement (GIC; Riva Self-Cure, SDI), supplied in capsules or in powder/liquid kits and placed in Class I cavities in permanent molars by the Atraumatic Restorative Treatment (ART) approach. A total of 80 restorations were randomly placed in 40 patients aged 11-15 years. Each patient received one restoration with each type of GIC. The restorations were evaluated after periods of 15 days (baseline), 6 months, and 1 year, according to ART criteria. Wilcoxon matched pairs, multivariate logistic regression, and Gehan-Wilcoxon tests were used for statistical analysis. Patients were evaluated after 15 days (n=40), 6 months (n=34), and 1 year (n=29). Encapsulated GICs showed significantly superior clinical performance compared with hand-mixed GICs at baseline (p=0.017), 6 months (p=0.001), and 1 year (p=0.026). For hand-mixed GIC, a statistically significant difference was only observed over the period of baseline to 1 year (p=0.001). Encapsulated GIC presented statistically significant differences for the following periods: 6 months to 1 year (p=0.028) and baseline to 1 year (p=0.002). Encapsulated GIC presented superior cumulative survival rate than hand-mixed GIC over one year. Importantly, both GICs exhibited decreased survival over time. Encapsulated GIC promoted better ART performance, with an annual failure rate of 24%; in contrast, hand-mixed GIC demonstrated a failure rate of 42%.

Comparison of two surgical procedures for use of the acellular dermal matrix graft in the treatment of gingival recessions: a randomized controlled clinical study.

PubMed

Felipe, Maria Emília M C; Andrade, Patrícia F; Grisi, Marcio F M; Souza, Sérgio L S; Taba, Mário; Palioto, Daniela B; Novaes, Arthur B

2007-07-01

The aim of this randomized, controlled, clinical investigation was to compare two surgical techniques for root coverage with the acellular dermal matrix graft to evaluate which technique provided better root coverage, a better esthetic result, and less postoperative discomfort. Fifteen patients with bilateral Miller Class I or II gingival recessions were selected. Fifteen pairs of recessions were treated and assigned randomly to the test group, and the contralateral recessions were assigned to the control group. The control group was treated with a broader flap and vertical releasing incisions; the test group was treated with the proposed surgical technique, without vertical releasing incisions. The clinical parameters evaluated were probing depth, relative clinical attachment level, gingival recession (GR), width of keratinized tissue, thickness of keratinized tissue, esthetic result, and pain evaluation. The measurements were taken before the surgeries and after 6 months. At baseline, all parameters were similar for both groups. At 6 months, a statistically significant greater reduction in GR favored the control group. The percentage of root coverage was 68.98% and 84.81% for the test and control groups, respectively. The esthetic result was equivalent between the groups, and all patients tolerated both procedures well. Both techniques provided significant root coverage, good esthetic results, and similar levels of postoperative discomfort. However, the control technique had statistically significantly better results for root coverage of localized gingival recessions.

Current evidence for the safety and efficacy of the bio-engineered dual therapy COMBO stent.

PubMed

Kalkman, Deborah N; Chandrasekhar, Jaya; de Winter, Robbert J; Mehran, Roxana

2018-06-01

The novel dual-therapy COMBO stent aims to promote vessel healing after percutaneous coronary intervention (PCI) in patients with coronary artery disease. The pro-healing technique consists of an anti-CD34+ antibody layer that attracts circulating endothelial progenitor cells (EPCs), which bind to the stent surface and allow rapid endothelialization by differentiation of the EPCs into normal endothelial cells. The COMBO stent combines this pro-healing technique with an abluminal drug elution of sirolimus. The promise of this dual-therapy stent is that it may safely allow a shortened duration of dual-antiplatelet therapy (DAPT) after stent placement. Moreover, with a mature endothelial layer, lower rates of in-stent restenosis may be expected. Clinical outcomes after COMBO stent implantation have been recently evaluated in both randomized trials and large, prospective, multicenter registries, showing low clinical event rates of in-stent restenosis and stent thrombosis. Randomized clinical trials (HARMONEE and RECOVERY) have demonstrated the non-inferiority of COMBO versus "first in class" second generation and newer generation drug-eluting stents. Safety and efficacy of 3 months of DAPT after COMBO stent placement in patients presenting with acute coronary syndrome has been evaluated in the large REDUCE randomized controlled trial, showing non-inferiority to standard duration of 12-month DAPT. In this review we provide an overview of the current pre-clinical and clinical evidence for the performance of the COMBO stent.

A randomized, double-blind, controlled clinical trial to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy volunteers.

PubMed

Jang, Hee-Chang; Kim, Choong Jong; Kim, Kye Hyoung; Lee, Kwang-Hee; Byun, Young-Ho; Seong, Baik-Lin; Saletti, Giulietta; Czerkinsky, Cecil; Park, Wan Beom; Park, Sang-Won; Kim, Hong-Bin; Kim, Nam Joong; Oh, Myoung-don

2010-08-16

A randomized, double-blind, controlled clinical trial was conducted to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, and to determine its minimum effective dose. The overall rates of cutaneous "take" reaction and humoral and cellular immunogenicity in CJ-50300 vaccinees were 100% (123/123), 99.2% (122/123), and 90.8% (109/120), respectively, and these rates did not differ significantly between the conventional-dose and the low-dose CJ-50300 (1.0x10(8) and 1.0x10(7) plaque-forming units/mL, respectively) (P>0.05 for each). No serious adverse reaction was observed. However, one case of possible generalized vaccinia occurred in the conventionally dosed group [ClinicalTrials.gov Identifier: NCT00607243].

The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials.

PubMed

Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

2017-12-01

The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain, rheumatoid arthritis, and osteoporosis) compared to baseline and non-mineral similar treatments. Internal validity and other limitations of the study's methodology impede causal relation of spa therapy on these improvements. Randomized clinical trials are very heterogeneous. Double-blind randomized clinical trials seem to be the key for studying the role of mineral elements and other chemical compounds, observing enough consistency to demonstrate better and longer improvements for mineral waters or derivate compared to tap water; but due to heterogeneity and gaps on study protocol and methodology, existing research is not sufficiently strong to draw firm conclusions. Well-designed studies in larger patients' population are needed to establish the role of minerals and other chemical compounds in spa therapy.

The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials

NASA Astrophysics Data System (ADS)

Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

2017-12-01

The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain, rheumatoid arthritis, and osteoporosis) compared to baseline and non-mineral similar treatments. Internal validity and other limitations of the study's methodology impede causal relation of spa therapy on these improvements. Randomized clinical trials are very heterogeneous. Double-blind randomized clinical trials seem to be the key for studying the role of mineral elements and other chemical compounds, observing enough consistency to demonstrate better and longer improvements for mineral waters or derivate compared to tap water; but due to heterogeneity and gaps on study protocol and methodology, existing research is not sufficiently strong to draw firm conclusions. Well-designed studies in larger patients' population are needed to establish the role of minerals and other chemical compounds in spa therapy.

Reproducibility of clinical research in critical care: a scoping review.

PubMed

Niven, Daniel J; McCormick, T Jared; Straus, Sharon E; Hemmelgarn, Brenda R; Jeffs, Lianne; Barnes, Tavish R M; Stelfox, Henry T

2018-02-21

The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies. We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals. To identify relevant clinical practices, we searched the New England Journal of Medicine, The Lancet, and JAMA for randomized trials published up to April 2016. To identify a comprehensive set of studies for these practices, included articles informed secondary searches within other high-impact medical and specialty journals. We included late-phase randomized controlled trials examining therapeutic clinical practices in adults admitted to general medical-surgical or specialty intensive care units (ICUs). Included articles were classified using a reproducibility framework. An original study was the first to evaluate a clinical practice. A reproduction attempt re-evaluated that practice in a new set of participants. Overall, 158 practices were examined in 275 included articles. A reproduction attempt was identified for 66 practices (42%, 95% CI 33-50%). Original studies reported larger effects than reproduction attempts (primary endpoint, risk difference 16.0%, 95% CI 11.6-20.5% vs. 8.4%, 95% CI 6.0-10.8%, P = 0.003). More than half of clinical practices with a reproduction attempt demonstrated effects that were inconsistent with the original study (56%, 95% CI 42-68%), among which a large number were reported to be efficacious in the original study and to lack efficacy in the reproduction attempt (34%, 95% CI 19-52%). Two practices reported to be efficacious in the original study were found to be harmful in the reproduction attempt. A minority of critical care practices with research published in high-profile journals were evaluated for reproducibility; less than half had reproducible effects.

Quasi-experiments to establish causal effects of HIV care and treatment and to improve the cascade of care

PubMed Central

Bor, Jacob; Geldsetzer, Pascal; Venkataramani, Atheendar; Bärnighausen, Till

2015-01-01

Purpose of review Randomized, population-representative trials of clinical interventions are rare. Quasi-experiments have been used successfully to generate causal evidence on the cascade of HIV care in a broad range of real-world settings. Recent findings Quasi-experiments exploit exogenous, or quasi-random, variation occurring naturally in the world or because of an administrative rule or policy change to estimate causal effects. Well designed quasi-experiments have greater internal validity than typical observational research designs. At the same time, quasi-experiments may also have potential for greater external validity than experiments and can be implemented when randomized clinical trials are infeasible or unethical. Quasi-experimental studies have established the causal effects of HIV testing and initiation of antiretroviral therapy on health, economic outcomes and sexual behaviors, as well as indirect effects on other community members. Recent quasi-experiments have evaluated specific interventions to improve patient performance in the cascade of care, providing causal evidence to optimize clinical management of HIV. Summary Quasi-experiments have generated important data on the real-world impacts of HIV testing and treatment and on interventions to improve the cascade of care. With the growth in large-scale clinical and administrative data, quasi-experiments enable rigorous evaluation of policies implemented in real-world settings. PMID:26371463

Quasi-experiments to establish causal effects of HIV care and treatment and to improve the cascade of care.

PubMed

Bor, Jacob; Geldsetzer, Pascal; Venkataramani, Atheendar; Bärnighausen, Till

2015-11-01

Randomized, population-representative trials of clinical interventions are rare. Quasi-experiments have been used successfully to generate causal evidence on the cascade of HIV care in a broad range of real-world settings. Quasi-experiments exploit exogenous, or quasi-random, variation occurring naturally in the world or because of an administrative rule or policy change to estimate causal effects. Well designed quasi-experiments have greater internal validity than typical observational research designs. At the same time, quasi-experiments may also have potential for greater external validity than experiments and can be implemented when randomized clinical trials are infeasible or unethical. Quasi-experimental studies have established the causal effects of HIV testing and initiation of antiretroviral therapy on health, economic outcomes and sexual behaviors, as well as indirect effects on other community members. Recent quasi-experiments have evaluated specific interventions to improve patient performance in the cascade of care, providing causal evidence to optimize clinical management of HIV. Quasi-experiments have generated important data on the real-world impacts of HIV testing and treatment and on interventions to improve the cascade of care. With the growth in large-scale clinical and administrative data, quasi-experiments enable rigorous evaluation of policies implemented in real-world settings.

Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial

PubMed Central

DUTRA, Bernardo Carvalho; OLIVEIRA, Alcione Maria Soares Dutra; OLIVEIRA, Peterson Antônio Dutra; MANZI, Flavio Ricardo; CORTELLI, Sheila Cavalca; COTA, Luís Otávio de Miranda; COSTA, Fernando Oliveira

2017-01-01

Abstract Background and objectives Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Material and Methods Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Results Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Conclusions Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy. PMID:28678950

A comparison of dentifrices for clinical relief from dentin hypersensitivity using the Jay Sensitivity Sensor Probe.

PubMed

Hegde, Shashikanth; Rao, B H Sripathi; Kakar, Ravish Chander; Kakar, Ashish

2013-05-01

To evaluate the clinical relief from dentin hypersensitivity among subjects provided with a dentifrice formulated with 8% arginine, calcium carbonate and 1,000 ppm fluoride [sodium monofluorophosphate (MFP)] in comparison to those issued a commercially available dentifrice containing 1,000 ppm fluoride [as sodium monofluorophosphate (MFP)]. Clinical evaluations for hypersensitivity were performed with a novel tactile hypersensitivity measuring instrument--the Jay Sensitivity Sensor (Jay) Probe--in conjunction with evaporative triggers by air blast (Schiff scale) and Visual Analog Scores (VAS). Qualified adults from the Mangalore, India area who presented two teeth with dentin hypersensitivity were enrolled for this double-blind, randomized, parallel, controlled clinical trial conducted in an outpatient clinical setting. At baseline, dentin hypersensitivity was evaluated by the Jay Probe (tactile), air blast and VAS methods. Subjects were randomly issued a study dentifrice and instructed to brush their teeth for 1 minute twice daily with the provided dentifrice. Clinical evaluations for hypersensitivity were repeated after 2, 4 and 8 weeks of product use. 86 subjects (35 males and 51 females) complied with the study protocol and completed the entire study. At each recall visit, both treatment groups demonstrated significant reductions in dentin hypersensitivity from their corresponding baselines (P < 0.05). Subjects assigned the 8% arginine, calcium carbonate and 1,000 ppm fluoride dentifrice demonstrated statistically significant reductions in responses to tactile stimuli, air blast, and VAS responses in comparison to those using the dentifrice containing 1,000 ppm fluoride after 2, 4, and 8 weeks, respectively.

Evaluation of a Standardized Extract from Morus alba against α-Glucosidase Inhibitory Effect and Postprandial Antihyperglycemic in Patients with Impaired Glucose Tolerance: A Randomized Double-Blind Clinical Trial

PubMed Central

Hwang, Seung Hwan; Li, Hong Mei; Wang, Zhiqiang

2016-01-01

To evaluate the antihyperglycemic effect of a standardized extract of the leaves of Morus alba (SEMA), the present study was designed to investigate the α-glucosidase inhibitory effect and acute single oral toxicity as well as evaluate blood glucose reduction in animals and in patients with impaired glucose tolerance in a randomized double-blind clinical trial. SEMA was found to inhibit α-glucosidase at a fourfold higher level than the positive control (acarbose), in a concentration-dependent manner. Moreover, blood glucose concentration was suppressed by SEMA in vivo. Clinical signs and weight changes were observed when conducting an evaluation of the acute toxicity of SEMA through a single-time administration, with clinical observation conducted more than once each day. After administration of the SEMA, observation was for 14 days; all of the animals did not die and did not show any abnormal symptoms. In addition, the inhibitory effects of rice coated with SEMA were evaluated in a group of impaired glucose tolerance patients on postprandial glucose and a group of normal persons, and results showed that SEMA had a clear inhibitory effect on postprandial hyperglycemia in both groups. Overall, SEMA showed excellent potential in the present study as a material for improving postprandial hyperglycemia. PMID:27974904

Description of interventions is under-reported in physical therapy clinical trials.

PubMed

Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

A comparison of Chevron and Lindgren-Turan osteotomy techniques in hallux valgus surgery: a prospective randomized controlled study.

PubMed

Uygur, Esat; Özkan, Namık Kemal; Akan, Kaya; Çift, Hakan

2016-01-01

The aim of this prospective randomized controlled single-blind study was to compare the results of Chevron and Lindgren-Turan osteotomy techniques for treatment of moderate hallux valgus. A total of 66 female patients (34 in Chevron group, 32 Lindgren-Turan group) were recruited in this study and followed up for an average of 26.08 months. Operative procedures were performed by 2 surgeons, and patients were evaluated by an another researcher who was blinded to the surgical technique. The groups were compared for their radiological and clinical results. Both techniques was clinically and radiologically effective (p<0.01). However, no significant differences were found between the 2 groups regarding American Orthopaedic Foot and Ankle Society's clinical rating system, Painful Foot Evaluation scale of Maryland University scores, or radiologic evaluation (p>0.05). Compared to the Chevron group, the Lindgren-Turan group was found to have shorter surgical duration (p<0.05) and significantly more shortening at the first metatarsal (p<0.05). In moderate hallux valgus deformity, both the Chevron and Lindgren-Turan osteotomy techniques are clinically and radiologically safe, effective, and reliable alternatives. No superiority was detected in either technique. Although shortening at the first metatarsal in the Lindgren-Turan group was radiologically significant, the results were clinically tolerable.

A randomized evaluation of smoking cessation interventions for pregnant women at a WIC clinic.

PubMed Central

Mayer, J P; Hawkins, B; Todd, R

1990-01-01

Pregnant smokers attending a local health department WIC clinic were randomly assigned to one of two self-help smoking cessation programs or usual care. The multiple component program resulted in larger quit rates than usual care during the last month of pregnancy (11 percent vs 3 percent) and postpartum (7 percent vs 0 percent). Achieving quit rates in WIC similar to those in studies conducted at prenatal care settings, suggests that smoking cessation programs for low-income pregnant WIC clients are feasible. PMID:2293809

Microbiological and clinical effects of probiotics and antibiotics on nonsurgical treatment of chronic periodontitis: a randomized placebo- controlled trial with 9-month follow-up

PubMed Central

Morales, Alicia; Gandolfo, Alessandro; Bravo, Joel; Carvajal, Paola; Silva, Nora; Godoy, Claudia; Garcia-Sesnich, Jocelyn; Hoare, Anilei; Diaz, Patricia; Gamonal, Jorge

2018-01-01

ABSTRACT Objective The aim of this double-blind, placebo-controlled and parallel- arm randomized clinical trial was to evaluate the effects of Lactobacillus rhamnosus SP1-containing probiotic sachet and azithromycin tablets as an adjunct to nonsurgical therapy in clinical parameters and in presence and levels of Tannerella forsythia, Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Material and Methods Forty-seven systemically healthy volunteers with chronic periodontitis were recruited and monitored clinically and microbiologically at baseline for 3, 6 and 9 months after therapy. Subgingival plaque samples were collected from four periodontal sites with clinical attachment level ≥1 mm, probing pocket depth ≥4 mm and bleeding on probing, one site in each quadrant. Samples were cultivated and processed using the PCR technique. Patients received nonsurgical therapy including scaling and root planing (SRP) and were randomly assigned to a probiotic (n=16), antibiotic (n = 16) or placebo (n = 15) group. L. rhamnosus SP1 was taken once a day for 3 months. Azithromycin 500mg was taken once a day for 5 days. Results All groups showed improvements in clinical and microbiological parameters at all time points evaluated. Probiotic and antibiotic groups showed greater reductions in cultivable microbiota compared with baseline. The placebo group showed greater reduction in number of subjects with P. gingivalis compared with baseline. However, there were no significant differences between groups. Conclusions The adjunctive use of L. rhamnosus SP1 sachets and azithromycin during initial therapy resulted in similar clinical and microbiological improvements compared with the placebo group. PMID:29364340

Hydrogen Gas Inhalation Treatment in Acute Cerebral Infarction: A Randomized Controlled Clinical Study on Safety and Neuroprotection.

PubMed

Ono, Hirohisa; Nishijima, Yoji; Ohta, Shigeo; Sakamoto, Masaki; Kinone, Kazunori; Horikosi, Tohru; Tamaki, Mituyuki; Takeshita, Hirosi; Futatuki, Tomoko; Ohishi, Wataru; Ishiguro, Taichi; Okamoto, Saori; Ishii, Shou; Takanami, Hiroko

2017-11-01

Molecular hydrogen (H 2 ) acts as a therapeutic antioxidant. Inhalation of H 2 gas (1-4%) was effective for the improvement of cerebral infarction in multiple animal experiments. Thus, for actual applications, a randomized controlled clinical study is desired to evaluate the effects of inhalation of H 2 gas. Here, we evaluate the H 2 treatment on acute cerebral infarction. Through this randomized controlled clinical study, we assessed the safety and effectiveness of H 2 treatment in patients with cerebral infarction in an acute stage with mild- to moderate-severity National Institute of Health Stroke Scale (NIHSS) scores (NIHSS = 2-6). We enrolled 50 patients (25 each in the H 2 group and the control group) with a therapeutic time window of 6 to 24 hours. The H 2 group inhaled 3% H 2 gas (1 hour twice a day), and the control group received conventional intravenous medications for the initial 7 days. The evaluations included daily vital signs, NIHSS scores, physical therapy indices, weekly blood chemistry, and brain magnetic resonance imaging (MRI) scans over the 2-week study period. The H 2 group showed no significant adverse effects with improvements in oxygen saturation. The following significant effects were found: the relative signal intensity of MRI, which indicated the severity of the infarction site, NIHSS scores for clinically quantifying stroke severity, and physical therapy evaluation, as judged by the Barthel Index. H 2 treatment was safe and effective in patients with acute cerebral infarction. These results suggested a potential for widespread and general application of H 2 gas. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol.

PubMed

Recio-Rodríguez, José I; Martín-Cantera, Carlos; González-Viejo, Natividad; Gómez-Arranz, Amparo; Arietaleanizbeascoa, Maria S; Schmolling-Guinovart, Yolanda; Maderuelo-Fernandez, Jose A; Pérez-Arechaederra, Diana; Rodriguez-Sanchez, Emiliano; Gómez-Marcos, Manuel A; García-Ortiz, Luis

2014-03-15

New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. Clinical Trials.gov Identifier: NCT02016014.

A Randomized Controlled Trial of a Behavioral Economic Supplement to Brief Motivational Interventions for College Drinking

ERIC Educational Resources Information Center

Murphy, James G.; Dennhardt, Ashley A.; Skidmore, Jessica R.; Borsari, Brian; Barnett, Nancy P.; Colby, Suzanne M.; Martens, Matthew P.

2012-01-01

Objective: Behavioral economic theory suggests that a reduction in substance use is most likely when there is an increase in rewarding substance-free activities. The goal of this randomized controlled clinical trial was to evaluate the incremental efficacy of a novel behavioral economic supplement (Substance-Free Activity Session [SFAS]) to a…

Potential surrogate endpoints for prostate cancer survival: analysis of a phase III randomized trial.

PubMed

Ray, Michael E; Bae, Kyounghwa; Hussain, Maha H A; Hanks, Gerald E; Shipley, William U; Sandler, Howard M

2009-02-18

The identification of surrogate endpoints for prostate cancer-specific survival may shorten the length of clinical trials for prostate cancer. We evaluated distant metastasis and general clinical treatment failure as potential surrogates for prostate cancer-specific survival by use of data from the Radiation Therapy and Oncology Group 92-02 randomized trial. Patients (n = 1554 randomly assigned and 1521 evaluable for this analysis) with locally advanced prostate cancer had been treated with 4 months of neoadjuvant and concurrent androgen deprivation therapy with external beam radiation therapy and then randomly assigned to no additional therapy (control arm) or 24 additional months of androgen deprivation therapy (experimental arm). Data from landmark analyses at 3 and 5 years for general clinical treatment failure (defined as documented local disease progression, regional or distant metastasis, initiation of androgen deprivation therapy, or a prostate-specific antigen level of 25 ng/mL or higher after radiation therapy) and/or distant metastasis were tested as surrogate endpoints for prostate cancer-specific survival at 10 years by use of Prentice's four criteria. All statistical tests were two-sided. At 3 years, 1364 patients were alive and contributed data for analysis. Both distant metastasis and general clinical treatment failure at 3 years were consistent with all four of Prentice's criteria for being surrogate endpoints for prostate cancer-specific survival at 10 years. At 5 years, 1178 patients were alive and contributed data for analysis. Although prostate cancer-specific survival was not statistically significantly different between treatment arms at 5 years (P = .08), both endpoints were consistent with Prentice's remaining criteria. Distant metastasis and general clinical treatment failure at 3 years may be candidate surrogate endpoints for prostate cancer-specific survival at 10 years. These endpoints, however, must be validated in other datasets.

Zhen gan xi feng decoction, a traditional chinese herbal formula, for the treatment of essential hypertension: a systematic review of randomized controlled trials.

PubMed

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use.

The Medical Treatment of New-Onset Peripartum Cardiomyopathy: A Systematic Review of Prospective Studies.

PubMed

Desplantie, Olivier; Tremblay-Gravel, Maxime; Avram, Robert; Marquis-Gravel, Guillaume; Ducharme, Anique; Jolicoeur, E Marc

2015-12-01

Peripartum cardiomyopathy (PPCM) is a rare disorder with potentially fatal consequences, which occurs mainly in previously healthy women. The aetiology of PPCM remains unknown and various pathologic mechanisms have been proposed, including immune-mediated injuries and impaired response to oxidative stress and inflammatory cytokines. Several therapies have been studied, but few have been validated in a well-designed randomized controlled trial. In the present study we sought to review the medical treatment intended for acute PPCM. To this end, we performed a systematic review of the literature of randomized and nonrandomized prospective clinical studies. We identified 2 randomized controlled trials that evaluated the dopamine agonist bromocriptine and the inotrope levosimendan, respectively, and 1 nonrandomized study that evaluated the nonselective phosphodiesterase inhibitor pentoxifylline. We reviewed the pathophysiological, pharmacological, and clinical properties for each treatment option identified. Bromocriptine and pentoxifylline both improved left ventricular systolic function and patient-oriented clinical end points and levosimendan did not improve mortality or echocardiographic findings of PPCM. In this review we identified bromocriptine and pentoxifylline, but not levosimendan, as potentially useful agents to improve left ventricle function and outcomes in PPCM. Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

PubMed

Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

2015-04-01

Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream. © The Author(s) 2015.

The effect of cactus pear (Opuntia ficus-indica) on body weight and cardiovascular risk factors: a systematic review and meta-analysis of randomized clinical trials.

PubMed

Onakpoya, Igho J; O'Sullivan, Jack; Heneghan, Carl J

2015-05-01

Hundreds of dietary supplements are currently marketed as weight loss supplements. However, the advertised health claims of effectiveness for most of these have not been proven. The aim of this study was to critically appraise and evaluate the evidence for effectiveness of cactus pear, Opuntia ficus-indica (OFI), using data from published randomized clinical trials. We conducted electronic searches in Medline, Embase, Amed, Cinahl, and the Cochrane Library. No restrictions on age, time, or language were imposed. The risk for bias in the studies included was assessed using the Cochrane Collaboration criteria. Two reviewers independently determined the eligibility of included studies, assessed reporting quality, and extracted data. We identified seven eligible studies, of which five were included. The studies varied in design and reporting quality. Meta-analysis revealed a nonsignificant difference in body weight between OFI and controls (mean difference = -0.83 kg; 95% confidence interval, -2.49 to 0.83; I(2) = 93%). Significant reductions in body mass index, percentage body fat, systolic and diastolic blood pressures, and total cholesterol were observed. Adverse events included gastric intolerance and flu symptoms. The evidence from randomized clinical trials does not indicate that supplementation with OFI generates statistically significant effects on body weight. Consumption of OFI can cause significant reductions in percentage body fat, blood pressure, and total cholesterol. Few clinical trials evaluating the effects of OFI have been published. They vary in design and methodology, and are characterized by inconsistent quality of reporting. Further clinical trials evaluating the effects of OFI on body composition and metabolic parameters are warranted. Copyright © 2015 Elsevier Inc. All rights reserved.

A randomized trial comparing INR monitoring devices in patients with anticoagulation self-management: evaluation of a novel error-grid approach.

PubMed

Hemkens, Lars G; Hilden, Kristian M; Hartschen, Stephan; Kaiser, Thomas; Didjurgeit, Ulrike; Hansen, Roland; Bender, Ralf; Sawicki, Peter T

2008-08-01

In addition to the metrological quality of international normalized ratio (INR) monitoring devices used in patients' self-management of long-term anticoagulation, the effectiveness of self-monitoring with such devices has to be evaluated under real-life conditions with a focus on clinical implications. An approach to evaluate the clinical significance of inaccuracies is the error-grid analysis as already established in self-monitoring of blood glucose. Two anticoagulation monitors were compared in a real-life setting and a novel error-grid instrument for oral anticoagulation has been evaluated. In a randomized crossover study 16 patients performed self-management of anticoagulation using the INRatio and the CoaguChek S system. Main outcome measures were clinically relevant INR differences according to established criteria and to the error-grid approach. A lower rate of clinically relevant disagreements according to Anderson's criteria was found with CoaguChek S than with INRatio without statistical significance (10.77% vs. 12.90%; P = 0.787). Using the error-grid we found principally consistent results: More measurement pairs with discrepancies of no or low clinical relevance were found with CoaguChek S, whereas with INRatio we found more differences with a moderate clinical relevance. A high rate of patients' satisfaction with both of the point of care devices was found with only marginal differences. A principal appropriateness of the investigated point-of-care devices to adequately monitor the INR is shown. The error-grid is useful for comparing monitoring methods with a focus on clinical relevance under real-life conditions beyond assessing the pure metrological quality, but we emphasize that additional trials using this instrument with larger patient populations are needed to detect differences in clinically relevant disagreements.

Non-operative management of posterior tibialis tendon dysfunction: design of a randomized clinical trial [NCT00279630

PubMed Central

Kulig, Kornelia; Pomrantz, Amy B; Burnfield, Judith M; Reischl, Stephen F; Mais-Requejo, Susan; Thordarson, David B; Smith, Ronald W

2006-01-01

Background Posterior tibialis tendon dysfunction (PTTD) is a common cause of foot pain and dysfunction in adults. Clinical observations strongly suggest that the condition is progressive. There are currently no controlled studies evaluating the effectiveness of exercise, orthoses, or orthoses and exercise on Stage I or IIA PTTD. Our study will explore the effectiveness of an eccentric versus concentric strengthening intervention to results obtained with the use of orthoses alone. Findings from this study will guide the development of more efficacious PTTD intervention programs and contribute to enhanced function and quality of life in persons with posterior tibialis tendon dysfunction. Methods/design This paper presents the rationale and design for a randomized clinical trial evaluating the effectiveness of a treatment regime for the non-operative management of Stage I or IIA PTTD. Discussion We have presented the rationale and design for an RCT evaluating the effectiveness of a treatment regimen for the non-operative management of Stage I or IIA PTTD. The results of this trial will be presented as soon as they are available. PMID:16756656

Recognizing and managing a deteriorating patient: a randomized controlled trial investigating the effectiveness of clinical simulation in improving clinical performance in undergraduate nursing students.

PubMed

Stayt, Louise Caroline; Merriman, Clair; Ricketts, Barry; Morton, Sean; Simpson, Trevor

2015-11-01

To report the results of a randomized controlled trial which explored the effectiveness of clinical simulation in improving the clinical performance of recognizing and managing an adult deteriorating patient in hospital. There is evidence that final year undergraduate nurses may lack knowledge, clinical skills and situation awareness required to manage a deteriorating patient competently. The effectiveness of clinical simulation as a strategy to teach the skills required to recognize and manage the early signs of deterioration needs to be evaluated. This study was a two centre phase II single, randomized, controlled trial with single blinded assessments. Data were collected in July 2013. Ninety-eight first year nursing students were randomized either into a control group, where they received a traditional lecture, or an intervention group where they received simulation. Participants completed a pre- and postintervention objective structured clinical examination. General Perceived Self Efficacy and Self-Reported Competency scores were measured before and after the intervention. Student satisfaction with teaching was also surveyed. The intervention group performed significantly better in the post-objective structured clinical examination. There was no significant difference in the postintervention General Perceived Self Efficacy and Self-Reported Competency scores between the control and intervention group. The intervention group was significantly more satisfied with their teaching method. Simulation-based education may be an effective educational strategy to teach nurses the skills to effectively recognize and manage a deteriorating patient. © 2015 John Wiley & Sons Ltd.

Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness. Methods/Design This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN52695239 PMID:24330810

A prospective, randomized, double blind, placebo-controlled evaluation of the effects of eicosapentaenoic acid and docosahexaenoic acid on the clinical signs and erythrocyte membrane polyunsaturated fatty acid concentrations in dogs with osteoarthritis.

PubMed

Mehler, Stephen J; May, Lauren R; King, Crystal; Harris, William S; Shah, Zubin

2016-06-01

Osteoarthritis (OA) in dogs is a prevalent and serious condition. The most common treatment for the clinical signs of OA in dogs is the administration of nonsteroidal antiiflammatory pharmaceuticals. Omega-3 (n-3) fatty acids have been shown to reduce the clinical signs of osteoarthritis in dogs. The primary goals of this study were 1) to determine the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on the clinical signs of OA in dogs, 2) to evaluate the effects of supplementation on the arachadonic acid (ARA)/ (EPA+DHA) algorithm and 3) to correlate alterations in the ARA/(EPA+DHA) with changes in the clinical signs of canine OA. Seventy-eight client owned dogs were enrolled in a prospective, randomized, double-blind, placebo controlled clinical trial. Dogs were randomized to placebo oil or triglyceride n-3 oil (providing an average dose of 69mg EPA+DHA/kg/day). Orthopedic examinations and blood analyses were performed at baseline, day 42, and day 84. A single investigator confirmed a diagnosis of OA of the coxofemoral joints and/or stifle joints in all dogs. Seventy-four dogs completed the trial. All clinical outcomes for measuring discomfort, lameness, and joint severity at day 84 and all blood metrics at day 42 and day 84 significantly (p<0.05) improved compared with placebo. No major side effects were observed. This study demonstrated that the daily supplementation of a dogs diet with EPA and DHA shifts the blood fatty acid concentrations correlating to relief of clinical signs associated with OA in dogs. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Randomized phase 2 trial to evaluate the clinical efficacy of two high-dosage tigecycline regimens versus imipenem-cilastatin for treatment of hospital-acquired pneumonia.

PubMed

Ramirez, Julio; Dartois, Nathalie; Gandjini, Hassan; Yan, Jean Li; Korth-Bradley, Joan; McGovern, Paul C

2013-04-01

In a previous phase 3 study, the cure rates that occurred in patients with hospital-acquired pneumonia treated with tigecycline at the approved dose were lower than those seen with patients treated with imipenem and cilastatin (imipenem/cilastatin). We hypothesized that a higher dose of tigecycline is necessary in patients with hospital-acquired pneumonia. This phase 2 study compared the safety and efficacy of two higher doses of tigecycline with imipenem/cilastatin in subjects with hospital-acquired pneumonia. Subjects with hospital-acquired pneumonia were randomized to receive one of two doses of tigecycline (150 mg followed by 75 mg every 12 h or 200 mg followed by 100 mg every 12 h) or 1 g of imipenem/cilastatin every 8 h. Empirical adjunctive therapy was administered for initial coverage of methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa infection, depending on the randomization regimen. Clinical response, defined as cure, failure of treatment, or indeterminate outcome, was assessed 10 to 21 days after the last day of therapy. In the clinically evaluable population, clinical cure with tigecycline 100 mg (17/20, 85.0%) was numerically higher than with tigecycline 75 mg (16/23, 69.6%) and imipenem/cilastatin (18/24, 75.0%). No new safety signals with the high-dose tigecycline were identified. A numerically higher clinical response was observed with the 100-mg dose of tigecycline. This supports our hypothesis that a higher area under the concentration-time curve over 24 h in the steady state divided by the MIC (AUC/MIC ratio) may be necessary to achieve clinical cure in patients with hospital-acquired pneumonia. Further studies are necessary. (The ClinicalTrials.gov identifier for this clinical trial is NCT00707239.).

Novel solutions for an old disease: diagnosis of acute appendicitis with random forest, support vector machines, and artificial neural networks.

PubMed

Hsieh, Chung-Ho; Lu, Ruey-Hwa; Lee, Nai-Hsin; Chiu, Wen-Ta; Hsu, Min-Huei; Li, Yu-Chuan Jack

2011-01-01

Diagnosing acute appendicitis clinically is still difficult. We developed random forests, support vector machines, and artificial neural network models to diagnose acute appendicitis. Between January 2006 and December 2008, patients who had a consultation session with surgeons for suspected acute appendicitis were enrolled. Seventy-five percent of the data set was used to construct models including random forest, support vector machines, artificial neural networks, and logistic regression. Twenty-five percent of the data set was withheld to evaluate model performance. The area under the receiver operating characteristic curve (AUC) was used to evaluate performance, which was compared with that of the Alvarado score. Data from a total of 180 patients were collected, 135 used for training and 45 for testing. The mean age of patients was 39.4 years (range, 16-85). Final diagnosis revealed 115 patients with and 65 without appendicitis. The AUC of random forest, support vector machines, artificial neural networks, logistic regression, and Alvarado was 0.98, 0.96, 0.91, 0.87, and 0.77, respectively. The sensitivity, specificity, positive, and negative predictive values of random forest were 94%, 100%, 100%, and 87%, respectively. Random forest performed better than artificial neural networks, logistic regression, and Alvarado. We demonstrated that random forest can predict acute appendicitis with good accuracy and, deployed appropriately, can be an effective tool in clinical decision making. Copyright © 2011 Mosby, Inc. All rights reserved.

Low versus high volume of culture medium during embryo transfer: a randomized clinical trial.

PubMed

Sigalos, George Α; Michalopoulos, Yannis; Kastoras, Athanasios G; Triantafyllidou, Olga; Vlahos, Nikos F

2018-04-01

The aim of this prospective randomized control trial was to evaluate if the use of two different volumes (20-25 vs 40-45 μl) of media used for embryo transfer affects the clinical outcomes in fresh in vitro fertilization (IVF) cycles. In total, 236 patients were randomized in two groups, i.e., "low volume" group (n = 118) transferring the embryos with 20-25 μl of medium and "high volume" group (n = 118) transferring the embryos with 40-45 μl of medium. The clinical pregnancy, implantation, and ongoing pregnancy rates were compared between the two groups. No statistically significant differences were observed in clinical pregnancy (46.8 vs 54.3%, p = 0.27), implantation (23.7 vs 27.8%, p = 0.30), and ongoing pregnancy (33.3 vs 40.0%, p = 0.31) rates between low and high volume group, respectively. Higher volume of culture medium to load the embryo into the catheter during embryo transfer does not influence the clinical outcome in fresh IVF cycles. NCT03350646.

Comparative effectiveness of next generation genomic sequencing for disease diagnosis: design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes.

PubMed

Gallego, Carlos J; Bennette, Caroline S; Heagerty, Patrick; Comstock, Bryan; Horike-Pyne, Martha; Hisama, Fuki; Amendola, Laura M; Bennett, Robin L; Dorschner, Michael O; Tarczy-Hornoch, Peter; Grady, William M; Fullerton, S Malia; Trinidad, Susan B; Regier, Dean A; Nickerson, Deborah A; Burke, Wylie; Patrick, Donald L; Jarvik, Gail P; Veenstra, David L

2014-09-01

Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effectiveness and patient-centered outcomes research. We designed a randomized controlled trial that incorporates these research methods to evaluate whole exome sequencing compared to usual care in patients being evaluated for hereditary colorectal cancer and polyposis syndromes. Approximately 220 patients will be randomized and followed for 12 months after return of genomic findings. Patients will receive findings associated with colorectal cancer in a first return of results visit, and findings not associated with colorectal cancer (incidental findings) during a second return of results visit. The primary outcome is efficacy to detect mutations associated with these syndromes; secondary outcomes include psychosocial impact, cost-effectiveness and comparative costs. The secondary outcomes will be obtained via surveys before and after each return visit. The expected challenges in conducting this randomized controlled trial include the relatively low prevalence of genetic disease, difficult interpretation of some genetic variants, and uncertainty about which incidental findings should be returned to patients. The approaches utilized in this study may help guide other investigators in clinical genomics to identify useful outcome measures and strategies to address comparative effectiveness questions about the clinical implementation of genomic sequencing in clinical care. Copyright © 2014 Elsevier Inc. All rights reserved.

The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications.

PubMed

Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

2014-10-01

To assess the proportion of clinical trials explicitly reporting the risk of unblinding, to evaluate the completeness of reporting on unblinding risk, and to describe the reported procedures involved in assessing unblinding. We sampled at random 300 blinded randomized clinical trials indexed in PubMed in 2010. Two authors read the trial publications and extracted data independently. Twenty-four trial publications, or 8% (95% confidence interval [CI], 5, 12%), explicitly reported the risk of unblinding, of which 16 publications, or 5% (95% CI, 3, 8%), reported compromised blinding; and 8 publications, or 3% (95% CI, 1, 5%), intact blinding. The reporting on risk of unblinding in the 24 trial publications was generally incomplete. The median proportion of assessments per trial affected by unblinding was 3% (range 1-30%). The most common mechanism for unblinding was perceptible physical properties of the treatments, for example, a difference in the taste and odor of a typhoid vaccine compared with its placebo. Published articles on randomized clinical trials infrequently reported risk of unblinding. This may reflect a tendency for avoiding reporting actual or suspected unblinding or a genuine low risk of unblinding. Copyright © 2014 Elsevier Inc. All rights reserved.

Randomized clinical trial of encapsulated and hand-mixed glass-ionomer ART restorations: one-year follow-up

PubMed Central

Freitas, Maria Cristina Carvalho de Almendra; Fagundes, Ticiane Cestari; Modena, Karin Cristina da Silva; Cardia, Guilherme Saintive; Navarro, Maria Fidela de Lima

2018-01-01

Abstract Objective This prospective, randomized, split-mouth clinical trial evaluated the clinical performance of conventional glass ionomer cement (GIC; Riva Self-Cure, SDI), supplied in capsules or in powder/liquid kits and placed in Class I cavities in permanent molars by the Atraumatic Restorative Treatment (ART) approach. Material and Methods A total of 80 restorations were randomly placed in 40 patients aged 11-15 years. Each patient received one restoration with each type of GIC. The restorations were evaluated after periods of 15 days (baseline), 6 months, and 1 year, according to ART criteria. Wilcoxon matched pairs, multivariate logistic regression, and Gehan-Wilcoxon tests were used for statistical analysis. Results Patients were evaluated after 15 days (n=40), 6 months (n=34), and 1 year (n=29). Encapsulated GICs showed significantly superior clinical performance compared with hand-mixed GICs at baseline (p=0.017), 6 months (p=0.001), and 1 year (p=0.026). For hand-mixed GIC, a statistically significant difference was only observed over the period of baseline to 1 year (p=0.001). Encapsulated GIC presented statistically significant differences for the following periods: 6 months to 1 year (p=0.028) and baseline to 1 year (p=0.002). Encapsulated GIC presented superior cumulative survival rate than hand-mixed GIC over one year. Importantly, both GICs exhibited decreased survival over time. Conclusions Encapsulated GIC promoted better ART performance, with an annual failure rate of 24%; in contrast, hand-mixed GIC demonstrated a failure rate of 42%. PMID:29364343

Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for type-2 diabetes mellitus: study protocol for a randomized controlled trial.

PubMed

Ranasinghe, Priyanga; Galappaththy, Priyadarshani; Constantine, Godwin Roger; Jayawardena, Ranil; Weeratunga, Hasitha Dhananjaya; Premakumara, Sirimal; Katulanda, Prasad

2017-09-29

Previous studies have explored the anti-diabetic effects of Cinnamomum cassia extract in vivo and in vitro. However, there are no studies at present exploring the effects of the indigenous species of Sri Lankan cinnamon (Cinnamomum zeylanicum) in patients with diabetes mellitus. The present study aims to evaluate the potential effects of Cinnamomum zeylanicum extract as a pharmaceutical agent in patients with type-2 diabetes mellitus. The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 4 months at the Medical Clinic, University Medical Unit, National Hospital of Sri Lanka. A total of 210 subjects with diabetes, in three equal groups, will be recruited for the study. The patients will be randomized in a 1:1:1 ratio according to the method of block randomization and the subjects will be randomly and equally assigned into two test groups (n = 70 each) and one placebo group (n = 70). The population will be stratified at randomization based on age, gender and disease severity. The treatment drug is a capsule containing Cinnamomum zeylanicum extract as the active ingredient and the placebo capsule will contain lactose monohydrate. Two doses of Cinnamomum zeylanicum extracts (250 mg and 500 mg of the cinnamon extract) will be used. The study drugs will be double blinded to both investigators and participants. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 2 months (visit 2), 3 months (visit 3) and 4 months (visit 4). The following primary outcome measures will be evaluated: glycosylated hemoglobin (HbA 1 c), fasting plasma glucose (FPG) and serum insulin. Secondary outcome measures include: Body Mass Index (BMI) and other anthropometric parameters, blood pressure, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL) and triglycerides (TAG). Data will be analyzed using SPSS version 14. We describe the protocol for a clinical trial design evaluating the effects of Cinnamomum zeylanicum (Ceylon cinnamon) in patients with type-2 diabetes mellitus. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of cinnamon dietary supplementation in patients with diabetes. Sri Lanka Clinical Trials Registry (SLCTR), identifier: SLCTR/2017/010 ( http://slctr.lk/trials/714 ). Registered on 5 April 2017; study protocol version 3.1 21 March 2017.

Development and Evaluation of a Clinical Note Section Header Terminology

PubMed Central

Denny, Joshua C.; Miller, Randolph A.; Johnson, Kevin B.; Spickard, Anderson

2008-01-01

Clinical documentation is often expressed in natural language text, yet providers often use common organizations that segment these notes in sections, such as “history of present illness” or “physical examination.” We developed a hierarchical section header terminology, supporting mappings to LOINC and other vocabularies; it contained 1109 concepts and 4332 synonyms. Physicians evaluated it compared to LOINC and the Evaluation and Management billing schema using a randomly selected corpus of history and physical notes. Evaluated documents contained a median of 54 sections and 27 “major sections.” There were 16,196 total sections in the evaluation note corpus. The terminology contained 99.9% of the clinical sections; LOINC matched 77% of section header concepts and 20% of section header strings in those documents. The section terminology may enable better clinical note understanding and interoperability. Future development and integration into natural language processing systems is needed. PMID:18999303

Implementing Clinical Research Using Factorial Designs: A Primer.

PubMed

Baker, Timothy B; Smith, Stevens S; Bolt, Daniel M; Loh, Wei-Yin; Mermelstein, Robin; Fiore, Michael C; Piper, Megan E; Collins, Linda M

2017-07-01

Factorial experiments have rarely been used in the development or evaluation of clinical interventions. However, factorial designs offer advantages over randomized controlled trial designs, the latter being much more frequently used in such research. Factorial designs are highly efficient (permitting evaluation of multiple intervention components with good statistical power) and present the opportunity to detect interactions amongst intervention components. Such advantages have led methodologists to advocate for the greater use of factorial designs in research on clinical interventions (Collins, Dziak, & Li, 2009). However, researchers considering the use of such designs in clinical research face a series of choices that have consequential implications for the interpretability and value of the experimental results. These choices include: whether to use a factorial design, selection of the number and type of factors to include, how to address the compatibility of the different factors included, whether and how to avoid confounds between the type and number of interventions a participant receives, and how to interpret interactions. The use of factorial designs in clinical intervention research poses choices that differ from those typically considered in randomized clinical trial designs. However, the great information yield of the former encourages clinical researchers' increased and careful execution of such designs. Copyright © 2017. Published by Elsevier Ltd.

Thinking outside the Randomized Controlled Trials Experimental Box: Strategies for Enhancing Credibility and Social Justice

ERIC Educational Resources Information Center

Hesse-Biber, Sharlene

2013-01-01

Some evaluators employ randomized controlled trials (RCTs) as the gold standard of evidence-based practice (EBP). Critics of RCT designs argue that RCTs do not include the complexity of program participants' experiences or clinical expertise, and couple this with criticisms that it is difficult to transfer RCT findings from the laboratory to…

Evaluation of a Brief Parent Intervention Teaching Coping-Promoting Behavior for the Infant Immunization Context: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Bustos, Theona; Jaaniste, Tiina; Salmon, Karen; Champion, G. David

2008-01-01

This study was designed to investigate whether a brief intervention encouraging parental coping-promoting talk within the treatment room would have beneficial effects on infant pain responses to an immunization injection. Infant-parent dyads were recruited from a 6-month immunization clinic and randomized to an intervention group (n = 25) or…

Randomized Trial Outcomes of a TTM-Tailored Condom Use and Smoking Intervention in Urban Adolescent Females

ERIC Educational Resources Information Center

Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.

2015-01-01

Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females…

ModerateDrinking.com and Moderation Management: Outcomes of a Randomized Clinical Trial with Non-Dependent Problem Drinkers

ERIC Educational Resources Information Center

Hester, Reid K.; Delaney, Harold D.; Campbell, William

2011-01-01

Objective: To evaluate the effectiveness of a web-based protocol, ModerateDrinking.com (MD; "www.moderatedrinking.com") combined with use of the online resources of Moderation Management (MM; "www.moderation.org") as opposed to the use of the online resources of MM alone. Method: We randomly assigned 80 problem drinkers to…

The Acute Effect of Methylphenidate in Brazilian Male Children and Adolescents with ADHD: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Szobot, C. M.; Ketzer, C.; Parente, M. A.; Biederman, J.; Rohde, L. A.

2004-01-01

Objective: To evaluate the acute efficacy of methylphenidate (MPH) in Brazilian male children and adolescents with ADHD. Method: In a 4-day, double-blind, placebo-controlled, randomized, fix dose escalating, parallel-group trial, 36 ADHD children and adolescents were allocated to two groups: MPH (n = 19) and placebo (n = 17). Participants were…

Comparison of the analgesic efficacy of oral ketorolac versus intramuscular tramadol after third molar surgery: A parallel, double-blind, randomized, placebo-controlled clinical trial.

PubMed

Isiordia-Espinoza, M-A; Pozos-Guillen, A; Martinez-Rider, R; Perez-Urizar, J

2016-09-01

Preemptive analgesia is considered an alternative for treating the postsurgical pain of third molar removal. The aim of this study was to evaluate the preemptive analgesic efficacy of oral ketorolac versus intramuscular tramadol after a mandibular third molar surgery. A parallel, double-blind, randomized, placebo-controlled clinical trial was carried out. Thirty patients were randomized into two treatment groups using a series of random numbers: Group A, oral ketorolac 10 mg plus intramuscular placebo (1 mL saline solution); or Group B, oral placebo (similar tablet to oral ketorolac) plus intramuscular tramadol 50 mg diluted in 1 mL saline solution. These treatments were given 30 min before the surgery. We evaluated the time of first analgesic rescue medication, pain intensity, total analgesic consumption and adverse effects. Patients taking oral ketorolac had longer time of analgesic covering and less postoperative pain when compared with patients receiving intramuscular tramadol. According to the VAS and UAC results, this study suggests that 10 mg of oral ketorolac had superior analgesic effect than 50 mg of tramadol when administered before a mandibular third molar surgery.

Treatment of Anxiety in Patients with Coronary Heart Disease: Rationale and Design of the UNWIND Randomized Clinical Trial

PubMed Central

Blumenthal, James A.; Feger, Bryan J.; Smith, Patrick J.; Watkins, Lana L.; Jiang, Wei; Davidson, Jonathan; Hoffman, Benson M.; Ashworth, Megan; Mabe, Stephanie K.; Babyak, Michael A.; Kraus, William E.; Hinderliter, Alan; Sherwood, Andrew

2016-01-01

Background Anxiety is highly prevalent among patients with coronary heart disease (CHD), and there is growing evidence that high levels of anxiety are associated with worse prognosis. However, few studies have evaluated the efficacy of treating anxiety in CHD patients for reducing symptoms and improving clinical outcomes. Exercise and selective serotonin reuptake inhibitors have been shown to be effective in treating patients with depression, but have not been studied in cardiac patients with high anxiety. Methods The UNWIND trial is a randomized clinical trial of patients with CHD who are at increased risk for adverse events because of comorbid anxiety. One hundred fifty participants with CHD and elevated anxiety symptoms and/or with a diagnosed anxiety disorder will be randomly assigned to 12 weeks of aerobic exercise (3×/wk, 35 min, 70–85% VO2peak), escitalopram (5–20 mg qd), or placebo. Before and after 12 weeks of treatment, participants will undergo assessments of anxiety symptoms and CHD biomarkers of risk, including measures of inflammation, lipids, hemoglobin A1c, heart rate variability, and vascular endothelial function. Primary outcomes include post-intervention effects on symptoms of anxiety and CHD biomarkers. Secondary outcomes include clinical outcomes (cardiovascular hospitalizations and all-cause death) and measures of quality of life. Conclusions The UNWIND trial (ClinicalTrials.gov NCT02516332) will evaluate the efficacy of aerobic exercise and escitalopram for improving anxiety symptoms and reducing risk for adverse clinical events in anxious CHD patients. PMID:27264220

Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting.

PubMed

Massey, Paul R; Wang, Ruibin; Prasad, Vinay; Bates, Susan E; Fojo, Tito

2016-03-01

Despite the ethical imperative to publish clinical trials when human subjects are involved, such data frequently remain unpublished. The objectives were to tabulate the rate and ascertain factors associated with eventual publication of clinical trial results reported as abstracts in the Proceedings of the American Society of Clinical Oncology (American Society of Clinical Oncology). Abstracts describing clinical trials for patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to 2011 were identified by using a comprehensive online database (http://meetinglibrary.asco.org/abstracts). Abstracts included reported results of a treatment or intervention assessed in a discrete, prospective clinical trial. Publication status at 4-6 years was determined by using a standardized search of PubMed. Primary outcomes were the rate of publication for abstracts of randomized and nonrandomized clinical trials. Secondary outcomes included factors influencing the publication of results. A total of 1,075 abstracts describing 378 randomized and 697 nonrandomized clinical trials were evaluated. Across all years, 75% of randomized and 54% of nonrandomized trials were published, with an overall publication rate of 61%. Sample size was a statistically significant predictor of publication for both randomized and nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23 [1.11-1.36], p < .001; and 1.64 [1.15-2.34], p = .006, respectively). Among randomized studies, an industry coauthor or involvement of a cooperative group increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01, respectively). Among nonrandomized studies, phase II trials were more likely to be published than phase I (p < .001). Use of an experimental agent was not a predictor of publication in randomized (OR 0.76 [0.38-1.52]; p = .441) or nonrandomized trials (OR 0.89 [0.61-1.29]; p = .532). This is the largest reported study examining why oncology trials are not published. The data show that 4-6 years after appearing as abstracts, 39% of oncology clinical trials remain unpublished. Larger sample size and advanced trial phase were associated with eventual publication; among randomized trials, an industry-affiliated author or a cooperative group increased likelihood of publication. Unfortunately, we found that, despite widespread recognition of the problem and the creation of central data repositories, timely publishing of oncology clinical trials results remains unsatisfactory. ©AlphaMed Press.

Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

PubMed

Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

2017-02-01

Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

Improving care of patients with diabetes and CKD: a pilot study for a cluster-randomized trial.

PubMed

Cortés-Sanabria, Laura; Cabrera-Pivaral, Carlos E; Cueto-Manzano, Alfonso M; Rojas-Campos, Enrique; Barragán, Graciela; Hernández-Anaya, Moisés; Martínez-Ramírez, Héctor R

2008-05-01

Family physicians may have the main role in managing patients with type 2 diabetes mellitus with early nephropathy. It is therefore important to determine the clinical competence of family physicians in preserving renal function of patients. The aim of this study is to evaluate the effect of an educational intervention on family physicians' clinical competence and subsequently determine the impact on kidney function of their patients with type 2 diabetes mellitus. Pilot study for a cluster-randomized trial. Primary health care units of the Mexican Institute of Social Security, Guadalajara, Mexico. The study group was composed of 21 family physicians from 1 unit and a control group of 19 family physicians from another unit. 46 patients treated by study physicians and 48 treated by control physicians also were evaluated. An educative strategy based on a participative model used during 6 months in the study group. Allocation of units to receive or not receive the educative intervention was randomly established. Clinical competence of family physicians and kidney function of patients. To evaluate clinical competence, a validated questionnaire measuring family physicians' capability to identify risk factors, integrate diagnosis, and correctly use laboratory tests and therapeutic resources was applied to all physicians at the beginning and end of educative intervention (0 and 6 months). In patients, serum creatinine level, estimated glomerular filtration rate, and albuminuria were evaluated at 0, 6, and 12 months. At the end of the intervention, more family physicians from the study group improved clinical competence (91%) compared with controls (37%; P = 0.001). Family physicians in the study group who increased their competence improved renal function significantly better than physicians in the same group who did not increase competence and physicians in the control group (with or without increase in competence): change in estimated glomerular filtration rate, 0.9 versus -33, -21, and -16 mL/min/1.73 m(2) (P < 0.05); and change in urinary albumin excretion of -18 versus 226, 142, and 288 mg/d, respectively (P < 0.05). Compared with other groups, study family physicians with clinical competence also controlled systolic blood pressure significantly better and were more likely to increase the use of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and statins and to discontinue nonsteroidal anti-inflammatory drugs. Our analysis did not adjust for clustering. Physicians in only 2 units were randomly assigned; thus, it is not possible to distinguish the effect of the intervention from the effect of the unit. Educative intervention to primary physicians is feasible. Our data may be the basis for additional prospective studies with a cluster-randomized trial design and larger numbers of centers, physicians, and patients.

A study of active learning methods for named entity recognition in clinical text.

PubMed

Chen, Yukun; Lasko, Thomas A; Mei, Qiaozhu; Denny, Joshua C; Xu, Hua

2015-12-01

Named entity recognition (NER), a sequential labeling task, is one of the fundamental tasks for building clinical natural language processing (NLP) systems. Machine learning (ML) based approaches can achieve good performance, but they often require large amounts of annotated samples, which are expensive to build due to the requirement of domain experts in annotation. Active learning (AL), a sample selection approach integrated with supervised ML, aims to minimize the annotation cost while maximizing the performance of ML-based models. In this study, our goal was to develop and evaluate both existing and new AL methods for a clinical NER task to identify concepts of medical problems, treatments, and lab tests from the clinical notes. Using the annotated NER corpus from the 2010 i2b2/VA NLP challenge that contained 349 clinical documents with 20,423 unique sentences, we simulated AL experiments using a number of existing and novel algorithms in three different categories including uncertainty-based, diversity-based, and baseline sampling strategies. They were compared with the passive learning that uses random sampling. Learning curves that plot performance of the NER model against the estimated annotation cost (based on number of sentences or words in the training set) were generated to evaluate different active learning and the passive learning methods and the area under the learning curve (ALC) score was computed. Based on the learning curves of F-measure vs. number of sentences, uncertainty sampling algorithms outperformed all other methods in ALC. Most diversity-based methods also performed better than random sampling in ALC. To achieve an F-measure of 0.80, the best method based on uncertainty sampling could save 66% annotations in sentences, as compared to random sampling. For the learning curves of F-measure vs. number of words, uncertainty sampling methods again outperformed all other methods in ALC. To achieve 0.80 in F-measure, in comparison to random sampling, the best uncertainty based method saved 42% annotations in words. But the best diversity based method reduced only 7% annotation effort. In the simulated setting, AL methods, particularly uncertainty-sampling based approaches, seemed to significantly save annotation cost for the clinical NER task. The actual benefit of active learning in clinical NER should be further evaluated in a real-time setting. Copyright © 2015 Elsevier Inc. All rights reserved.

Role of Internal Mammary Node Radiation as a Part of Modern Breast Cancer Radiation Therapy: A Systematic Review

DOE Office of Scientific and Technical Information (OSTI.GOV)

Verma, Vivek; Vicini, Frank; Tendulkar, Rahul D.

Purpose: Despite data from multiple randomized trials, the role of internal mammary lymph node irradiation as a part of regional nodal irradiation (IMLN RT–RNI) remains unanswered. Recent noteworthy data and modern RT techniques might identify a subset of patients who will benefit from IMLN RT–RNI, lending insight into the balance between improved outcomes and acceptable toxicity. We evaluated the current role of IMLN RT–RNI by analyzing randomized, prospective, and retrospective data. Methods and Materials: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a review of the published data was performed using PubMed to evaluate publishedmore » studies from 1994 to 2015. The information evaluated included the number of patients, follow-up period, technical aspects of RT, and outcomes (clinical outcomes, complications/toxicity). Results: We included 16 studies (4 randomized, 4 nonrandomized, 7 retrospective, and 1 meta-analysis). Although older randomized trials failed to show differences in clinical outcomes or toxicity with IMLN RT–RNI, recent randomized data suggest the potential for improved outcomes, including overall survival, with IMLN RT–RNI. Furthermore, nonrandomized data have suggested a potential benefit for central tumors with IMLN RT–RNI. Although recent data have suggested a potential increase in pulmonary complications with IMLN RT–RNI with the use of advanced radiation techniques, toxicity rates remain low with limited cardiac toxicity data available. Conclusions: Increasing data from recent randomized trials support the use of IMLN RT–RNI. IMLN RT can be considered based on the inclusion of IMLN RT as a part of RNI in recent trials and the inclusion criteria from IMLN RT–RNI trials and for patients with central or medial tumors and axillary disease.« less

The quality of the evidence base for clinical pathway effectiveness: room for improvement in the design of evaluation trials.

PubMed

Rotter, Thomas; Kinsman, Leigh; James, Erica; Machotta, Andreas; Steyerberg, Ewout W

2012-06-18

The purpose of this article is to report on the quality of the existing evidence base regarding the effectiveness of clinical pathway (CPW) research in the hospital setting. The analysis is based on a recently published Cochrane review of the effectiveness of CPWs. An integral component of the review process was a rigorous appraisal of the methodological quality of published CPW evaluations. This allowed the identification of strengths and limitations of the evidence base for CPW effectiveness. We followed the validated Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria for randomized and non-randomized clinical pathway evaluations. In addition, we tested the hypotheses that simple pre-post studies tend to overestimate CPW effects reported. Out of the 260 primary studies meeting CPW content criteria, only 27 studies met the EPOC study design criteria, with the majority of CPW studies (more than 70 %) excluded from the review on the basis that they were simple pre-post evaluations, mostly comparing two or more annual patient cohorts. Methodologically poor study designs are often used to evaluate CPWs and this compromises the quality of the existing evidence base. Cochrane EPOC methodological criteria, including the selection of rigorous study designs along with detailed descriptions of CPW development and implementation processes, are recommended for quantitative evaluations to improve the evidence base for the use of CPWs in hospitals.

21 CFR 900.3 - Application for approval as an accreditation body.

Code of Federal Regulations, 2013 CFR

2013-04-01

... reaccreditation clinical image review in accordance with § 900.4(c), random clinical image reviews in accordance with § 900.4(f), and additional mammography review in accordance with § 900.12(j); (B) Procedures for performing phantom image review; (C) Procedures for assessing mammography equipment evaluations and surveys...

21 CFR 900.3 - Application for approval as an accreditation body.

Code of Federal Regulations, 2014 CFR

2014-04-01

... reaccreditation clinical image review in accordance with § 900.4(c), random clinical image reviews in accordance with § 900.4(f), and additional mammography review in accordance with § 900.12(j); (B) Procedures for performing phantom image review; (C) Procedures for assessing mammography equipment evaluations and surveys...

21 CFR 900.3 - Application for approval as an accreditation body.

Code of Federal Regulations, 2012 CFR

2012-04-01

... reaccreditation clinical image review in accordance with § 900.4(c), random clinical image reviews in accordance with § 900.4(f), and additional mammography review in accordance with § 900.12(j); (B) Procedures for performing phantom image review; (C) Procedures for assessing mammography equipment evaluations and surveys...

The Treatment for Adolescents with Depression Study (TADS): Demographic and Clinical Characteristics

ERIC Educational Resources Information Center

n/a; n/a

2005-01-01

Objective: The Treatment for Adolescents With Depression Study is a multicenter, randomized clinical trial sponsored by the NIMH. This study is designed to evaluate the short- and long-term effectiveness of four treatments for adolescents with major depressive disorder: fluoxetine, cognitive-behavioral therapy, their combination, and, acutely,…

The effect of laser-assisted hatching on pregnancy outcomes of cryopreserved-thawed embryo transfer: a meta-analysis of randomized controlled trials.

PubMed

Zeng, MeiFang; Su, SuQin; Li, LiuMing

2018-04-01

It is well known that laser-assisted hatching (LAH) is the most popular and ideal embryo hatching technology, but the relevance to pregnancy outcomes of cryopreserved-thawed embryo transfer (ET) is controversial. The purpose of this meta-analysis was to evaluate the effects of LAH on pregnancy outcomes of cryopreserved-thawed ET. We searched for relevant studies published in the PubMed, EMBASE, and Cochrane Central databases up to March 2017. This meta-analysis was primarily used to evaluate the effect of laser-assisted hatching on assisted reproductive outcomes: clinical pregnancy, embryo implantation, multiple pregnancy, miscarriage, and live birth. Using the Mantel-Haenszel fixed effects model and random effects model, we determined the summary odds ratios (OR) with 95% confidence intervals (CIs). There were 12 randomized controlled trials (more than 2574 participants) included in our analysis. The rates of clinical pregnancy (OR = 1.65, 95% CI = 1.24-2.19, I 2  = 49), implantation (OR = 1.59, 95% CI = 1.06-2.38, I 2  = 82%), multiple pregnancy (OR = 2.30, 95% CI = 1.30-4.07, I 2  = 33%), miscarriage (OR = 0.86, 95% CI = 0.50-1.48, I 2  = 0%), and live birth (OR = 1.09, 95% CI = 0.77-1.54, I 2  = 0%) revealed comparable results for both groups. In summary, this meta-analysis demonstrates that LAH is related to a higher clinical pregnancy rate, embryo implantation rate, and multiple pregnancy rate in women with cryopreserved-thawed embryos. However, LAH is unlikely to increase live birth rates and miscarriage rates. Due to the small sample evaluated in the pool of included studies, large-scale, prospective, randomized, controlled trials are required to determine if these small effects are clinically relevant.

Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.

PubMed

Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

2018-04-01

Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children's heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28-82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). The recent literature in children's heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice.

Randomized controlled trials in children’s heart surgery in the 21st century: a systematic review

PubMed Central

Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

2018-01-01

Abstract OBJECTIVES Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children’s heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. METHODS We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. RESULTS We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28–82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). CONCLUSIONS The recent literature in children’s heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice. PMID:29186478

Prostate cancer, comorbidity, and participation in randomized controlled trials of therapy.

PubMed

Chao, Herta H; Mayer, Tina; Concato, John; Rose, Michal G; Uchio, Edward; Kelly, Wm Kevin

2010-03-01

Randomized controlled trials (RCTs) evaluate the potential benefits of chemotherapy regimens and guide clinical care for patients with cancer. Inclusion criteria for RCTs are usually stringent and may exclude many patients seen in clinical practice. Our objective was to determine the proportion of men with castrate-resistant prostate cancer (CRPC) in a clinical setting that would have been excluded from major phase 3 RCTs. We reviewed eligibility criteria from 24 phase 3 clinical trials evaluating chemotherapy for CRPC active from January, 2004, through April, 2008. We created a common list of criteria used in at least 3 studies and separately considered the criteria from a prominent RCT (TAX 327). We applied these criteria to a population of patients with CRPC treated during 2004 to 2006 at the Veterans Affairs Connecticut Healthcare System. Among 106 patients with CRPC, 99 (93%) had complete medical records, and 45 (45%) of the 99 would have been excluded from RCTs. Common reasons for exclusion were abnormal laboratory values, other malignancies, and other serious medical conditions including cardiac disease. Almost half of the CRPC patients examined in a clinical setting would have been ineligible for phase 3 RCTs, highlighting that such trials may not be applicable to general oncology practice.

Designs and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics.

PubMed

Simon, Richard

2008-06-01

Developments in genomics and biotechnology provide unprecedented opportunities for the development of effective therapeutics and companion diagnostics for matching the right drug to the right patient. Effective co-development involves many new challenges with increased opportunity for success as well as delay and failure. Clinical trial designs and adaptive analysis plans for the prospective design of pivotal trials of new therapeutics and companion diagnostics are reviewed. Effective co-development requires careful prospective planning of the design and analysis strategy for pivotal clinical trials. Randomized clinical trials continue to be important for evaluating the effectiveness of new treatments, but the target populations for analysis should be prospectively specified based on the companion diagnostic. Post hoc analyses of traditionally designed randomized clinical trials are often deeply problematic. Clear separation is generally required of the data used for developing the diagnostic test, including their threshold of positivity, from the data used for evaluating treatment effectiveness in subsets determined by the test. Adaptive analysis can be used to provide flexibility to the analysis but the use of such methods requires careful planning and prospective definition in order to assure that the pivotal trial adequately limits the chance of erroneous conclusions.

The effectiveness of a simulated scenario to teach nursing students how to perform a bed bath: A randomized clinical trial.

PubMed

Miranda, Renata Pinto Ribeiro; de Cássia Lopes Chaves, Érika; Silva Lima, Rogério; Braga, Cristiane Giffoni; Simões, Ivandira Anselmo Ribeiro; Fava, Silvana Maria Coelho Leite; Iunes, Denise Hollanda

2017-10-01

Simulation allows students to develop several skills during a bed bath that are difficult to teach only in traditional classroom lectures, such as problem-solving, student interactions with the simulator (patient), reasoning in clinical evaluations, evaluation of responses to interventions, teamwork, communication, security and privacy. This study aimed to evaluate the effectiveness of a simulated bed bath scenario on improving cognitive knowledge, practical performance and satisfaction among nursing students. Randomized controlled clinical trial. Nursing students that were in the fifth period from two educational institutions in Brazil. Nursing students (n=58). The data were collected using the assessments of cognitive knowledge, practical performance and satisfaction were made through a written test about bed baths, an Objective Structured Clinical Examination (OSCE) and a satisfaction questionnaire. We identified that the acquisition and assimilation of cognitive knowledge was significantly higher in the simulation group (p=0.001). The performance was similar in both groups regardless of the teaching strategy (p=0.435). At follow-up, the simulation group had significantly more satisfaction with the teaching method than the control group (p=0.007). The teaching strategy based on a simulated scenario of a bed bath proved to be effective for the acquisition of cognitive knowledge regarding bed baths in clinical practice and improved student satisfaction with the teaching process. Copyright © 2017 Elsevier Ltd. All rights reserved.

Digital transillumination in caries detection versus radiographic and clinical methods: an in-vivo study

PubMed Central

Lara-Capi, Cynthia; Lingström, Peter; Lai, Gianfranco; Cocco, Fabio; Simark-Mattsson, Charlotte; Campus, Guglielmo

2017-01-01

Objectives: This article aimed to evaluate: (a) the agreement between a near-infrared light transillumination device and clinical and radiographic examinations in caries lesion detection and (b) the reliability of images captured by the transillumination device. Methods: Two calibrated examiners evaluated the caries status in premolars and molars on 52 randomly selected subjects by comparing the transillumination device with a clinical examination for the occlusal surfaces and by comparing the transillumination device with a radiographic examination (bitewing radiographs) for the approximal surfaces. Forty-eight trained dental hygienists evaluated and reevaluated 30 randomly selected images 1-month later. Results: A high concordance between transillumination method and clinical examination (kappa = 0.99) was detected for occlusal caries lesions, while for approximal surfaces, the transillumination device identified a higher number of lesions with respect to bitewing (kappa = 0.91). At the dentinal level, the two methods identified the same number of caries lesions (kappa = 1), whereas more approximal lesions were recorded using the transillumination device in the enamel (kappa = 0.24). The intraexaminer reliability was substantial/almost perfect in 59.4% of the participants. Conclusions: The transillumination method showed a high concordance compared with traditional methods (clinical examination and bitewing radiographs). Caries detection reliability using the transillumination device images showed a high intraexaminer agreement. Transillumination showed to be a reliable method and as effective as traditional methods in caries detection. PMID:28191797

Repair of dimethacrylate-based composite restorations by a silorane-based composite: a one-year randomized clinical trial.

PubMed

Popoff, D A V; Santa Rosa, T T A; Ferreira, R C; Magalhães, C S; Moreira, A N; Mjör, I A

2012-01-01

To investigate clinical performance of a low-shrinkage silorane-based composite resin when used for repairing conventional dimethacrylate-based composite restorations. Despite the continued development of resin-based materials, polymerization shrinkage and shrinkage stress still require improvement. A silorane-based monomer system was recently made available for dental restorations. This report refers to the use of this material for making repairs and evaluates the clinical performance of this alternative treatment. One operator repaired the defective dimethacrylate-based composite resin restorations that were randomly assigned to one of two treatment groups: control (n=50) repair with Adper SE Plus (3M/ESPE) and Filtek P60 Posterior Restorative (3M/ESPE), and test (n=50) repair with P90 System Adhesive Self-Etch Primer and Bond (3M/ESPE) and Filtek P90 Low Shrink Posterior Restorative (3M/ESPE). After one week, restorations were finished and polished. Two calibrated examiners (Kw≥0.78) evaluated all repaired restorations, blindly and independently, at baseline and one year. The parameters examined were marginal adaptation, anatomic form, surface roughness, marginal discoloration, postoperative sensitivity, and secondary caries. The restorations were classified as Alpha, Bravo, or Charlie, according to modified US Public Health Service criteria. Mann-Whitney and Wilcoxon tests were used to compare the groups. Of the 100 restorations repaired in this study, 93 were reexamined at baseline. Dropout from baseline to one-year recall was 11%. No statistically significant differences were found between the materials for all clinical criteria, at baseline or at one-year recall (p>0.05). No statistically significant differences were registered (p>0.05) for each material when compared for all clinical criteria at baseline and at one-year recall. The hypothesis tested in this randomized controlled clinical trial was accepted. After the one-year evaluations, the silorane-based composite exhibited a similar performance compared with dimethacrylate-based composite when used to make repairs.

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study.

PubMed

Micari, Antonio; Brodmann, Marianne; Keirse, Koen; Peeters, Patrick; Tepe, Gunnar; Frost, Martin; Wang, Hong; Zeller, Thomas

2018-05-28

The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296). Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Clinic-epidemiological evaluation of ulcers in patients with leprosy sequelae and the effect of low level laser therapy on wound healing: a randomized clinical trial

PubMed Central

2010-01-01

Background Mycobacterium leprae is the only pathogenic bacteria able to infect peripheral nerves. Neural impairment results in a set of sensitive, motor and autonomic disturbances, with ulcers originating primarily on the hands and feet. The study objectives were to analyze the clinic-epidemiological characteristics of patients attended at one specialized dressing service from a leprosy-endemic region of the Brazilian Amazon and to evaluate the effect of low level laser therapy (LLLT) on wound healing of these patients. Methods Clinic-epidemiological evaluation of patients with leprosy sequelae was performed at the reference unit in sanitary dermatology of the state of Pará in Brazil. We conducted anamnesis, identification of the regions affected by the lesions and measurement of ulcer depth and surface area. After that, we performed a randomized clinical trial. Fifty-one patients with ulcers related to leprosy were evaluated, twenty-five of them were randomly assigned to a low level laser therapy group or a control group. Patients were treated 3 times per week for 12 weeks. Outcome measures were ulcer surface area, ulcer depth and the pressure ulcer scale for healing score (PUSH). Results Ninety-seven ulcers were identified, with a mean (SD) duration of 97.6 (111.7) months, surface area of 7.3 (11.5) cm2, and depth of 6.0 (6.2) mm. Statistical analysis of the data determined that there were no significant differences in the variables analyzed before and after treatment with low level laser therapy. Conclusions Ulcers in patients with leprosy remain a major source of economic and social losses, even many years after they have been cured of M. leprae infection. Our results indicate that it is necessary to develop new and more effective therapeutic tools, as low level laser therapy did not demonstrate any additional benefits to ulcer healing with the parameters used in this study. Trial Registration The trial was registered at ClinicalTrials.gov as NCT00860717. PMID:20698989

Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers.

PubMed

Yoshita, Tomohiro; Uchida, Shinya; Namiki, Noriyuki

2013-01-01

Disintegration time is an important characteristic of orally disintegrating tablets (ODTs), and evaluation of disintegration time is a key step in formulation development, manufacturing, and clinical practice. In this study, we aimed to clarify the clinical disintegration time of ODTs that are currently used clinically, and to evaluate its correlation with the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=9-10; age range, 21-28 years). A randomized single-blind trial was performed; each tablet was placed on the tongues of the participants, and it disintegrated in their oral cavities. No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned. The clinical disintegration time of the 17 ODT products was between 17.6 s and 33.8 s. The in vitro disintegration time of 26 clinically used ODT products measured using Tricorptester ranged between 4.40 s and 30.4 s. A significant positive correlation was observed between in vitro and clinical disintegration times (r=0.79; p<0.001). This study shows that all the tested products, which are clinically available in Japan, showed good disintegration and that the disintegration time varied according to the product. In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity.

Levofloxacin compared with imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia: a multicenter, prospective, randomized, open-label study.

PubMed

West, Mike; Boulanger, Bernard R; Fogarty, Charles; Tennenberg, Alan; Wiesinger, Barbara; Oross, Margaret; Wu, Shu-Chen; Fowler, Cynthia; Morgan, Nancy; Kahn, James B

2003-02-01

Therapy of nosocomial pneumonia is usually empiric and includes > or = 1 broad-spectrum antimicrobial agent. When considering the use of fluoroquinolones in these difficult-to-treat infections--in which drug delivery to the site of infection may be impaired or organisms with higher minimum inhibitory concentrations may be present--an agent should be chosen whose pharmacodynamics ensure maximal drug exposure. Use of the 750-mg dose of levofloxacin should enhance therapeutic benefit in patients with nosocomial pneumonia. The goal of this study was to compare the efficacy and safety of levofloxacin 750 mg and imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia. This was a multicenter, prospective, randomized, open-label trial conducted in North America. Patients were randomly assigned to 1 of 2 treatment arms: levofloxacin 750 mg QD given i.v. and then orally for 7 to 15 days or imipenem/cilastatin 500 mg to 1 g i.v. every 6 to 8 hours, followed by oral ciprofloxacin 750 mg every 12 hours for 7 to 15 days. Adjunctive antibacterial therapy was mandatory in patients with documented or suspected Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus infection. The primary predefined outcome measure was the clinical response (cure, improvement, failure, or unable to evaluate) in microbiologically evaluable patients 3 to 15 days after the end of therapy. The study enrolled 438 adult patients (315 men, 123 women; mean [SD] age, 55.7 [20.04] years). Two hundred twenty patients received levofloxacin, and 218 received the comparator regimen. Demographic and baseline clinical characteristics were similar in the intent-to-treat and clinically evaluable populations. In patients evaluable for microbiologic efficacy, clinical success (cure or improvement) was achieved in 58.1% (54/93) of patients who received levofloxacin, compared with 60.6% (57/94) of patients who received the comparator regimen (95% CI, -12.0 to 17.2). Similar clinical results were seen in patients evaluable for clinical efficacy and in the intent-to-treat population. In the 187 patients evaluable for microbiologic efficacy, eradication was achieved in 66.7% (62/93) of patients receiving levofloxacin and 60.6% (57/94) of patients receiving the comparator regimen (95% CI, -20.3 to 8.3). In this study, levofloxacin was at least as effective and was as well tolerated as imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia, as demonstrated by comparable clinical and microbiologic success rates.

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial.

PubMed

Pontes, Caridad; Gratacós, Jordi; Torres, Ferran; Avendaño, Cristina; Sanz, Jesús; Vallano, Antoni; Juanola, Xavier; de Miguel, Eugenio; Sanmartí, Raimon; Calvo, Gonzalo

2015-08-20

Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. To address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015. The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers. EudraCT 2011-005871-18 (21 December 2011).

Early Effects of Responsivity Education/Prelinguistic Milieu Teaching for Children with Developmental Delays and Their Parents

ERIC Educational Resources Information Center

Fey, Marc E.; Warren, Steven F.; Brady, Nancy; Finestack, Lizbeth H.; Bredin-Oja, Shelley L.; Fairchild, Martha; Sokol, Shari; Yoder, Paul J.

2006-01-01

Purpose: To evaluate the efficacy of a 6-month course of responsivity education/prelinguistic milieu teaching (RE/PMT) for children with developmental delay and RE/PMT's effects on parenting stress in a randomized clinical trial. Method: Fifty-one children, age 24-33 months, with no more than 10 expressive words or signs, were randomly assigned to…

Comparison of virtual patient simulation with mannequin-based simulation for improving clinical performances in assessing and managing clinical deterioration: randomized controlled trial.

PubMed

Liaw, Sok Ying; Chan, Sally Wai-Chi; Chen, Fun-Gee; Hooi, Shing Chuan; Siau, Chiang

2014-09-17

Virtual patient simulation has grown substantially in health care education. A virtual patient simulation was developed as a refresher training course to reinforce nursing clinical performance in assessing and managing deteriorating patients. The objective of this study was to describe the development of the virtual patient simulation and evaluate its efficacy, by comparing with a conventional mannequin-based simulation, for improving the nursing students' performances in assessing and managing patients with clinical deterioration. A randomized controlled study was conducted with 57 third-year nursing students who were recruited through email. After a baseline evaluation of all participants' clinical performance in a simulated environment, the experimental group received a 2-hour fully automated virtual patient simulation while the control group received 2-hour facilitator-led mannequin-based simulation training. All participants were then re-tested one day (first posttest) and 2.5 months (second posttest) after the intervention. The participants from the experimental group completed a survey to evaluate their learning experiences with the newly developed virtual patient simulation. Compared to their baseline scores, both experimental and control groups demonstrated significant improvements (P<.001) in first and second post-test scores. While the experimental group had significantly lower (P<.05) second post-test scores compared with the first post-test scores, no significant difference (P=.94) was found between these two scores for the control group. The scores between groups did not differ significantly over time (P=.17). The virtual patient simulation was rated positively. A virtual patient simulation for a refreshing training course on assessing and managing clinical deterioration was developed. Although the randomized controlled study did not show that the virtual patient simulation was superior to mannequin-based simulation, both simulations have demonstrated to be effective refresher learning strategies for improving nursing students' clinical performance. Given the greater resource requirements of mannequin-based simulation, the virtual patient simulation provides a more promising alternative learning strategy to mitigate the decay of clinical performance over time.

The use of a non-benzodiazepine hypnotic sleep-aid (Zolpidem) in patients undergoing ACL reconstruction: a randomized controlled clinical trial.

PubMed

Tompkins, Marc; Plante, Matthew; Monchik, Keith; Fleming, Braden; Fadale, Paul

2011-05-01

Previous studies have addressed post-operative pain management after ACL reconstruction by examining the use of intra-articular analgesia and/or modification of anesthesia techniques. To our knowledge, however, no previous studies have evaluated the effect of zolpidem on post-operative narcotic requirements, pain, and fatigue in patients undergoing outpatient arthroscopic ACL reconstruction. The purpose of this prospective, blinded, randomized, controlled clinical study was to evaluate the effect of zolpidem on post-operative narcotic requirements, pain, and fatigue in patients undergoing outpatient arthroscopic ACL reconstruction. Twenty-nine patients undergoing arthroscopic ACL reconstruction were randomized to a treatment group or placebo group. Both groups received post-operative hydrocodone/acetaminophen bitartrate (Vicodin ES). Patients in the treatment group received a single dose of zolpidem for the first seven post-operative nights. Patients in the placebo group received a gelatin capsule similar in appearance to zolpidem. The amount of Vicodin used in each group, the amount of post-operative pain, and the amount of post-operative fatigue were analyzed. Following ACL reconstruction, a 28% reduction was seen in the total amount of narcotic consumed with zolpidem (P = 0.047) when compared to placebo. There were no significant differences in post-operative pain or fatigue levels between zolpidem and placebo. Adding zolpidem to the post-operative medication regimen after arthroscopic ACL reconstruction helps to lower the amount of narcotic pain medication required for adequate analgesia. Randomized controlled clinical trial, Level I.

Evaluation of increased milking frequency as an additional treatment for cows with clinical mastitis.

PubMed

Krömker, Volker; Zinke, Claudia; Paduch, Jan-Hendrik; Klocke, Doris; Reimann, Anette; Eller, Georg

2010-02-01

This field study focused on the possible effects of increased milking frequency (milking four times a day in comparison with milking twice a day) on clinical and bacteriological cure rates of clinical, antibiotically treated mastitis cases. Parameters tested were clinical, microbiological and full (cytomicrobiological) cure as well as the development of milk yield after the clinical mastitis episode. Cows from a large dairy herd meeting the study criteria (n=93) were assigned to two treatment groups by a systematic randomization scheme (blocked by body temperature <=or >39.5 degrees C). Both groups were randomly divided by experimental treatments: a) antibiotic intramammary treatment and milking 2-times a day; b) antibiotic intramammary treatment and milking 4-times a day. Treatments were initiated before the culture results were known. Cows were surveyed and evaluated on days 1-6, 24 and 31. No significant differences between treatment and control groups regarding clinical cure, microbiological cure, full cure and milk production could be established. Applying a 4-times a day milking regime did not lead to any significant effect, either positive or negative. Therefore, the results suggest that milking 4-times a day as a supporting therapy for mild, moderate and severe antimicrobially treated mastitis cases cannot be recommended.

[Multicenter randomized controlled clinical study on levornidazole and sodium chloride injection in the treatment of pelvic anaerobic infections].

PubMed

Ma, Ling; Zhang, Yuan-Zhen; Zheng, Yi-Lin; Wang, Ze-Hua; Xu, You-di; Kong, Li-Na

2010-10-01

to evaluate clinical efficacy and safety of levornidazole in the treatment of pelvic anaerobic infections. a multicenter randomized controlled clinical study was conducted to evaluate clinical efficacy and safety of levornidazole. One hundred and fourty-three patients with pelvic anaerobic bacteria infection were classified into 70 cases treated by levornidazole in study group and 73 cases treated by Ornidazole in control group. Those patients in two groups were both administered at a dose of 0.5 g twice daily for 5 - 7 days. The rate of clinical efficacy, bacteria clearance and adverse effect were recorded and compared between two groups. at the endpoint, the rate of clinical efficacy were 80% (56/70) in study group and 81% (59/73) in control group, which did not reach significant difference (P > 0.05). The rate of bacteria clearance were 97% (36/37) in study group and 92% (22/24) in control group, which also did not reach significant difference (P > 0.05). The rate of adverse reaction of 3% (20/70) in study group was significantly lower than 22% (16/73) in control group (P < 0.05). it is effective and safe to treat pelvic anaerobic infections with levornidazole and sodium chloride injection.

Contralateral eye comparison on changes in visual field following laser in situ keratomileusis vs photorefractive keratectomy for myopia: a randomized clinical trial.

PubMed

Mostafaei, A; Sedgipour, M R; Sadeghi-Bazargani, H

2009-12-01

Study purpose was to compare the changes of Visual Field (VF) during laser in situ Keratomileusis (LASIK) VS photorefractive keratectomy (PRK). This randomized, double blind, study involved 54 eyes of 27 Myopia patients who underwent LASIK or PRK procedures for contralateral eyes in each patient. Using Humphrey 30-2 SITA standard, the Mean Defect (MD) and Pattern Standard Deviation (PSD) were evaluated preoperatively and three months after surgery. At the same examination optical zone size, papillary and corneal diameters were also evaluated. There was no clinically significant difference in PSD and MD measurements between treated eyes with LASIK or PRK in any zone pre and postoperatively. VF may not be affected by corneal changes induced by LASIK or PRK three months after surgery.

Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.

PubMed

Bronas, Ulf G; Hirsch, Alan T; Murphy, Timothy; Badenhop, Dalynn; Collins, Tracie C; Ehrman, Jonathan K; Ershow, Abby G; Lewis, Beth; Treat-Jacobson, Diane J; Walsh, M Eileen; Oldenburg, Niki; Regensteiner, Judith G

2009-11-01

The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

Zhen Gan Xi Feng Decoction, a Traditional Chinese Herbal Formula, for the Treatment of Essential Hypertension: A Systematic Review of Randomized Controlled Trials

PubMed Central

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use. PMID:23573163

Bioactive glass granules: a suitable bone substitute material in the operative treatment of depressed lateral tibial plateau fractures: a prospective, randomized 1 year follow-up study.

PubMed

Heikkilä, Jouni T; Kukkonen, Juha; Aho, Allan J; Moisander, Susanna; Kyyrönen, Timo; Mattila, Kimmo

2011-04-01

Purpose of this study was to compare bioactive glass and autogenous bone as a bone substitute material in tibial plateau fractures. We designed a prospective, randomized study consisting of 25 consecutive operatively treated patients with depressed unilateral tibial comminuted plateau fracture (AO classification 41 B2 and B3).14 patients (7 females, 7 males, mean age 57 years, range 25-82) were randomized in the bioglass group (BG) and 11 patients (6 females, 5 males, mean age 50 years, range 31-82) served as autogenous bone control group (AB). Clinical examination of the patients was performed at 3 and 12 months, patients' subjective and functional results were evaluated at 12 months. Radiological analysis was performed preoperatively, immediately postoperatively and at 3 and 12 months. The postoperative redepression for both studied groups was 1 mm until 3 months and remained unchanged at 12 months. No differences were identified in the subjective evaluation, functional tests and clinical examination between the two groups during 1 year follow-up. We conclude that bioactive glass granules can be clinically used as filler material instead of autogenous bone in the lateral tibial plateau compression fractures.

Effect of Kangfuxin Solution on Chemo/Radiotherapy-Induced Mucositis in Nasopharyngeal Carcinoma Patients: A Multicenter, Prospective Randomized Phase III Clinical Study

PubMed Central

Luo, Yangkun; Feng, Mei; Fan, Zixuan; Zhu, Xiaodong; Jin, Feng; Li, Rongqing; Wu, Jingbo; Yang, Xia; Jiang, Qinghua; Bai, Hongfang; Huang, Yecai; Lang, Jinyi

2016-01-01

Objective. To evaluate the efficacy and safety of Kangfuxin Solution, a pure Chinese herbal medicine, on mucositis induced by chemoradiotherapy in nasopharyngeal carcinoma patients. Methods. A randomized, parallel-group, multicenter clinical study was performed. A total of 240 patients were randomized to receive either Kangfuxin Solution (test group) or compound borax gargle (control group) during chemoradiotherapy. Oral mucositis, upper gastrointestinal mucositis, and oral pain were evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and the Verbal Rating Scale (VRS). Results. Of 240 patients enrolled, 215 were eligible for efficacy analysis. Compared with the control group, the incidence and severity of oral mucositis in the test group were significantly reduced (P = 0.01). The time to different grade of oral mucositis occurrence (grade 1, 2, or 3) was longer in test group (P < 0.01), and the accumulated radiation dose was also higher in test group comparing to the control group (P < 0.05). The test group showed lower incidence of oral pain and gastrointestinal mucositis than the control group (P < 0.01). No significant adverse events were observed. Conclusion. Kangfuxin Solution demonstrated its superiority to compound borax gargle on mucositis induced by chemoradiotherapy. Its safety is acceptable for clinical application. PMID:27375766

A randomized, clinical trial of education or motivational-interviewing-based coaching compared to usual care to improve cancer pain management.

PubMed

Thomas, Mary Laudon; Elliott, Janette E; Rao, Stephen M; Fahey, Kathleen F; Paul, Steven M; Miaskowski, Christine

2012-01-01

To test the effectiveness of two interventions compared to usual care in decreasing attitudinal barriers to cancer pain management, decreasing pain intensity, and improving functional status and quality of life (QOL). Randomized clinical trial. Six outpatient oncology clinics (three Veterans Affairs [VA] facilities, one county hospital, and one community-based practice in California, and one VA clinic in New Jersey)Sample: 318 adults with various types of cancer-related pain. Patients were randomly assigned to one of three groups: control, standardized education, or coaching. Patients in the education and coaching groups viewed a video and received a pamphlet on managing cancer pain. In addition, patients in the coaching group participated in four telephone sessions with an advanced practice nurse interventionist using motivational interviewing techniques to decrease attitudinal barriers to cancer pain management. Questionnaires were completed at baseline and six weeks after the final telephone calls. Analysis of covariance was used to evaluate for differences in study outcomes among the three groups. Pain intensity, pain relief, pain interference, attitudinal barriers, functional status, and QOL. Attitudinal barrier scores did not change over time among groups. Patients randomized to the coaching group reported significant improvement in their ratings of pain-related interference with function, as well as general health, vitality, and mental health. Although additional evaluation is needed, coaching may be a useful strategy to help patients decrease attitudinal barriers toward cancer pain management and to better manage their cancer pain. By using motivational interviewing techniques, advanced practice oncology nurses can help patients develop an appropriate plan of care to decrease pain and other symptoms.

Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

PubMed

Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

2014-02-01

Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

A theory of eu-estrogenemia: a unifying concept

PubMed Central

Turner, Ralph J.; Kerber, Irwin J.

2017-01-01

Abstract Objective: The aim of the study was to propose a unifying theory for the role of estrogen in postmenopausal women through examples in basic science, randomized controlled trials, observational studies, and clinical practice. Methods: Review and evaluation of the literature relating to estrogen. Discussion: The role of hormone therapy and ubiquitous estrogen receptors after reproductive senescence gains insight from basic science models. Observational studies and individualized patient care in clinical practice may show outcomes that are not reproduced in randomized clinical trials. The understanding gained from the timing hypothesis for atherosclerosis, the critical window theory in neurosciences, randomized controlled trials, and numerous genomic and nongenomic actions of estrogen discovered in basic science provides new explanations to clinical challenges that practitioners face. Consequences of a hypo-estrogenemic duration in women's lives are poorly understood. The Study of Women Across the Nation suggests its magnitude is greater than was previously acknowledged. We propose that the healthy user bias was the result of surgical treatment (hysterectomy with oophorectomy) for many gynecological maladies followed by pharmacological and physiological doses of estrogen to optimize patient quality of life. The past decade of research has begun to demonstrate the role of estrogen in homeostasis. Conclusions: The theory of eu-estrogenemia provides a robust framework to unify the timing hypothesis, critical window theory, randomized controlled trials, the basic science of estrogen receptors, and clinical observations of patients over the past five decades. PMID:28562489

The use of a tracking test battery in the quantitative evaluation of neurological function

NASA Technical Reports Server (NTRS)

Repa, B. S.

1973-01-01

A number of tracking tasks that have proven useful to control engineers and psychologists measuring skilled performance have been evaluated for clinical use. Normal subjects as well as patients with previous diagnoses of Parkinson's disease, multiple sclerosis, and cerebral palsy were used in the evaluation. The tests that were studied included step tracking, random tracking, and critical tracking. The results of the present experiments encourage the continued use of tracking tasks as assessment precedures in a clinical environment. They have proven to be reliable, valid, and sensitive measures of neurological function.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

Evaluation of dyskinesias in a pilot, randomized, placebo-controlled trial of remacemide in advanced Parkinson disease.

PubMed

2001-10-01

Long-term levodopa therapy for Parkinson disease commonly results in motor complications including "on-off" fluctuations and dyskinesias, but it is still unclear how best to assess treatment effects on dyskinesias in clinical trials. To compare several methods of rating levodopa-induced dyskinesias to evaluate the effect of remacemide hydrochloride treatment in patients with advanced Parkinson disease. Two-week multicenter randomized, double-blind, placebo-controlled, parallel-group study. Five academic sites of the Parkinson Study Group. Thirty-nine subjects at least 30 years old with idiopathic Parkinson disease and disabling dyskinesias. Randomly received daily doses of 150 mg, 300 mg, or 600 mg of remacemide hydrochloride or matching placebo for 2 weeks. The dyskinesia rating scales used were the Modified Goetz Dyskinesia Rating scale (MGDRS), a newly created Lang-Fahn Activities of Daily Living Dyskinesia scale (LFADLDS), and diary dyskinesia ratings. Patient and investigator diaries showed excellent agreement in dyskinesia ratings. The MGDRS score correlated with clinic diary ratings of the percentage of "on" time with dyskinesias, and the LFADLDS score correlated with home and clinic diary assessments of percentage of on time with severe dyskinesias. The MGDRS score did not correlate highly with the LFADLDS score. This pilot study also validated previous results demonstrating the safety and tolerability of remacemide treatment for advanced Parkinson disease but did not result in any demonstrable improvement or worsening in dyskinesia measures. Diaries may provide a valid means of evaluating dyskinesias in clinical trials for Parkinson disease, but there remain other aspects of dyskinesias, as assessed by the MGDRS and LFADLDS, that are not reflected in diary ratings.

A randomized comparative study of levofloxacin versus amoxicillin/clavulanate for treatment of infants and young children with recurrent or persistent acute otitis media.

PubMed

Noel, Gary J; Blumer, Jeffrey L; Pichichero, Michael E; Hedrick, James A; Schwartz, Richard H; Balis, Dainius A; Melkote, Rama; Bagchi, Partha; Arguedas, Adriano

2008-06-01

The need for alternative antimicrobial therapy for recurrent and persistent acute otitis media (AOM) in children has raised interest in assessing the efficacy and safety of fluoroquinolones for treatment of these infections. In an evaluator-blinded, active-comparator, noninferiority, multicenter study, children (6 months to <5 years) were randomized 1:1 to receive levofloxacin (10 mg/kg twice daily) or amoxicillin/clavulanate (14:1; amoxicillin 45 mg/kg twice daily) for 10 days, with evaluations 4-6 days of therapy (visit 2), 2-5 days after completing therapy (visit 3), and 10-17 days after last dose (visit 4). Primary outcome was clinical cure at visit 3 based on resolution of clinical signs and symptoms of AOM. A total of 1650 children were randomized and 1305 were clinically evaluable at visit 3 (630 levofloxacin, 675 comparator). Clinical cure rates were 72.4% (456 of 630) in levofloxacin-treated and 69.9% (472 of 675) in amoxicillin/clavulanate-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (< or =24 months: 68.9% versus 66.2%; >24 months: 76.9% versus 75.1%; respectively). Cure rates at visit 4 were 74.9% and 73.8% in levofloxacin and amoxicillin/clavulanate groups, respectively. The upper limits of the confidence intervals were less than the noninferiority margin of 10% indicating that levofloxacin treatment is noninferior to comparator treatment overall and in both infants (6 months to 2 years) and children 2-5 years. No differences between treatment groups regarding the frequency or type of adverse events were apparent. Levofloxacin was not inferior to amoxicillin/clavulanate for the treatment of recurrent and/or persistent AOM in infants and children.

Extracorporeal shock wave therapy as an adjunct wound treatment: a systematic review of the literature.

PubMed

Dymarek, Robert; Halski, Tomasz; Ptaszkowski, Kuba; Slupska, Lucyna; Rosinczuk, Joanna; Taradaj, Jakub

2014-07-01

Standard care procedures for complex wounds are sometimes supported and reinforced by physical treatment modalities such as extracorporeal shock wave therapy (ESWT). To evaluate available evidence of ESWT effectiveness in humans, a systematic review of the literature was conducted using MEDLINE, PubMed, Scopus, EBSCOhost, and PEDro databases. Of the 393 articles found, 13 met the publication date (year 2000-2013), study type (clinical study), language (English only), and abstract availability (yes) criteria. The 13 studies (n = 919 patients with wounds of varying etiologies) included seven randomized controlled trials that were evaluated using Cochrane Collaboration Group standards. Only studies with randomization, well prepared inclusion/exclusion criteria protocol, written in English, and full version available were analyzed. An additional six publications reporting results of other clinical studies including a total of 523patients were identified and summarized. ESWT was most commonly applied once or twice a week using used low or medium energy, focused or defocused generator heads (energy range 0.03 to 0.25 mJ/mm2; usually 0.1 mJ/mm2), and electrohydraulic or electromagnetic sources. Few safety concerns were reported, and in the controlled clinical studies statistically significant differences in rates of wound closure were reported compared to a variety of standard topical treatment modalities, sham ESWT treatment, and hyperbaric oxygen therapy. Based on this analysis, ESWT can be characterized as noninvasive, mostly painless, and safe. Controlled, randomized, multicenter, blind clinical trials still are required to evaluate the efficacy and cost-effectiveness of ESWT compared to sham control, other adjunctive treatments, and commonly used moisture-retentive dressings. In the future, ESWT may play an important role in wound care once evidence-based practice guidelines are developed.

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

PubMed Central

Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa.

PubMed

Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E

2008-06-01

To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.

Effect of magnesium added to local anesthetics for caudal anesthesia on postoperative pain in pediatric surgical patients: A systematic review and meta-analysis with Trial Sequential Analysis.

PubMed

Kawakami, Hiromasa; Mihara, Takahiro; Nakamura, Nobuhito; Ka, Koui; Goto, Takahisa

2018-01-01

Magnesium has been investigated as an adjuvant for neuraxial anesthesia, but the effect of caudal magnesium on postoperative pain is inconsistent. The aim of this systematic review and meta-analysis was to evaluate the analgesic effect of caudal magnesium. We searched six databases, including trial registration sites. Randomized clinical trials reporting the effect of caudal magnesium on postoperative pain after general anesthesia were eligible. The risk ratio for use of rescue analgesics after surgery was combined using a random-effects model. We also assessed adverse events. The I2 statistic was used to assess heterogeneity. We assessed risk of bias with Cochrane domains. We controlled type I and II errors due to sparse data and repetitive testing with Trial Sequential Analysis. We assessed the quality of evidence with GRADE. Four randomized controlled trials (247 patients) evaluated the need for rescue analgesics. In all four trials, 50 mg of magnesium was administered with caudal ropivacaine. The results suggested that the need for rescue analgesia was reduced significantly by caudal magnesium administration (risk ratio 0.45; 95% confidence interval 0.24-0.86). There was considerable heterogeneity as indicated by an I2 value of 62.5%. The Trial Sequential Analysis-adjusted confidence interval was 0.04-5.55, indicating that further trials are required. The quality of evidence was very low. The rate of adverse events was comparable between treatment groups. Caudal magnesium may reduce the need for rescue analgesia after surgery, but further randomized clinical trials with a low risk of bias and a low risk of random errors are necessary to assess the effect of caudal magnesium on postoperative pain and adverse events. University Hospital Medical Information Network Clinical Trials Registry UMIN000025344.

Colorectal adenoma recurrence rates among post-polypectomy patients in the placebo-controlled groups of randomized clinical trials: a meta-analysis

PubMed Central

Shi, Xin; Yang, Zhiping; Wu, Qiong; Fan, Daiming

2017-01-01

Background Evidence regarding the benefit of therapy to prevent the post-polypectomy recurrence of colorectal adenoma is limited. Endoscopic recurrence is the main outcome according to an evaluation of trials involving recurrence prevention. Aim To estimate the recurrence rates of post-polypectomy colorectal adenoma in placebo-controlled arms of randomized clinical trials and to identify the prognostic factors influencing these rates. Methods We combined data from all randomized controlled trials evaluating therapies for colorectal adenoma using placebo from 1988 to 2016. The data were combined in a random-effects model. Primary outcomes were endoscopic adenoma and advanced adenoma recurrence of colorectal adenoma. Results The pooled estimates of the adenoma recurrence rates were 37% (95% confidence interval [CI], 33%-41%; range, 33%-52%) at 1 year, 47% (95% CI, 41%-54%; range, 46%-51%) at 2 years, 41% (95% CI, 33%-48%; range, 20%-61%) at 3 years, 48% (95% CI, 38%-57%; range, 37%-53%) at 4 years, and 60% (95% CI, 52%-68%; range, 48%-68%) at 5 years. The pooled estimates of the advanced adenoma recurrence rates were 10% (95% CI, 6%-15%; range, 7%-13%) at 1 year, 12% (95% CI, 8%-16%; range, 3%-19%) at 3 years, 14% (95% CI, 10%-18%; range, 13%-16%) at 4 years, and 14% (95% CI, 10%-19%; range, 9%-21%) at 5 years. Significant heterogeneity among the randomized clinical trials (P < 0.001) was observed for each recurrence rate. Conclusions This meta-analysis confirms the heterogeneity of recurrence rates among post-polypectomy colorectal adenoma patients who received placebo. No single design variable was identified that might explain the heterogeneity. PMID:28977952

Effectiveness of Modular CBT for Child Anxiety in Elementary Schools

ERIC Educational Resources Information Center

Chiu, Angela W.; Langer, David A.; McLeod, Bryce D.; Har, Kim; Drahota, Amy; Galla, Brian M.; Jacobs, Jeffrey; Ifekwunigwe, Muriel; Wood, Jeffrey J.

2013-01-01

Most randomized controlled trials of cognitive-behavioral therapy (CBT) for children with anxiety disorders have evaluated treatment efficacy using recruited samples treated in research settings. Clinical trials in school settings are needed to determine if CBT can be effective when delivered in real world settings. This study evaluated a modular…

Implementing Cognitive Behavioral Therapy for Chronic Fatigue Syndrome in a Mental Health Center: A Benchmarking Evaluation

ERIC Educational Resources Information Center

Scheeres, Korine; Wensing, Michel; Knoop, Hans; Bleijenberg, Gijs

2008-01-01

Objective: This study evaluated the success of implementing cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS) in a representative clinical practice setting and compared the patient outcomes with those of previously published randomized controlled trials (RCTs) of CBT for CFS. Method: The implementation interventions were the…

Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure.

PubMed

Joseph, Christine Lm; Ownby, Dennis R; Zoratti, Edward; Johnson, Dayna; Considine, Shannon; Bourgeois, Renee; Melkonian, Christina; Miree, Cheryl; Johnson, Christine Cole; Lu, Mei

2016-01-01

Modernized approaches to multisite randomized controlled trials (RCT) include the use of electronic medical records (EMR) for recruitment, remote data capture (RDC) for multisite data collection, and strategies to reduce the need for research infrastructure. These features facilitate the conduct of pragmatic trials, or trials conducted in "real life" settings. We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma. Using encounter and prescription databases, a list of potentially-eligible patients was linked to the Epic appointment scheduling system. Patients were enrolled during a scheduled visit and then electronically randomized to a tailored versus generic online intervention. 1146 appointments for 580 eligible patients visiting 5 clinics were identified, of which 45.9% (266/580) were randomized to reach targeted enrollment (n=250). RDC facilitated multisite enrollment. Intervention content was further personalized through real- time entry of asthma medications prescribed at the clinic visit. EMR monitoring helped with recruitment trouble-shooting. Systemic challenges included a system-wide EMR transition and a system-wide reorganization of clinic staffing. Modernized RCTs can accelerate translation of research findings. Electronic initiatives facilitated implementation of this RCT; however, adaptations to recruitment strategies resulted in a more "explanatory" framework. .

A novel complete-case analysis to determine statistical significance between treatments in an intention-to-treat population of randomized clinical trials involving missing data.

PubMed

Liu, Wei; Ding, Jinhui

2018-04-01

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.

Treatment of anxiety in patients with coronary heart disease: Rationale and design of the UNderstanding the benefits of exercise and escitalopram in anxious patients WIth coroNary heart Disease (UNWIND) randomized clinical trial.

PubMed

Blumenthal, James A; Feger, Bryan J; Smith, Patrick J; Watkins, Lana L; Jiang, Wei; Davidson, Jonathan; Hoffman, Benson M; Ashworth, Megan; Mabe, Stephanie K; Babyak, Michael A; Kraus, William E; Hinderliter, Alan; Sherwood, Andrew

2016-06-01

Anxiety is highly prevalent among patients with coronary heart disease (CHD), and there is growing evidence that high levels of anxiety are associated with worse prognosis. However, few studies have evaluated the efficacy of treating anxiety in CHD patients for reducing symptoms and improving clinical outcomes. Exercise and selective serotonin reuptake inhibitors have been shown to be effective in treating patients with depression, but have not been studied in cardiac patients with high anxiety. The UNWIND trial is a randomized clinical trial of patients with CHD who are at increased risk for adverse events because of comorbid anxiety. One hundred fifty participants with CHD and elevated anxiety symptoms and/or with a diagnosed anxiety disorder will be randomly assigned to 12 weeks of aerobic exercise (3×/wk, 35 min, 70%-85% VO2peak), escitalopram (5-20 mg qd), or placebo. Before and after 12 weeks of treatment, participants will undergo assessments of anxiety symptoms and CHD biomarkers of risk, including measures of inflammation, lipids, hemoglobin A1c, heart rate variability, and vascular endothelial function. Primary outcomes include post-intervention effects on symptoms of anxiety and CHD biomarkers. Secondary outcomes include clinical outcomes (cardiovascular hospitalizations and all-cause death) and measures of quality of life. The UNWIND trial (ClinicalTrials.gov NCT02516332) will evaluate the efficacy of aerobic exercise and escitalopram for improving anxiety symptoms and reducing risk for adverse clinical events in anxious CHD patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Hyperforin plasma level as a marker of treatment adherence in the National Institutes of Health Hypericum Depression Trial.

PubMed

Vitiello, Benedetto; Shader, Richard I; Parker, Corette B; Ritz, Louise; Harlan, William; Greenblatt, David J; Gadde, Kishore M; Krishnan, K Ranga R; Davidson, Jonathan R T

2005-06-01

A previously reported clinical trial of Hypericum perforatum (St John's wort) in depression did not demonstrate efficacy. We assessed treatment adherence by measuring plasma hyperforin and evaluated the possible impact of adherence on study results. Outpatients with major depression (N = 340) were randomized to an 8-week trial of H. perforatum (900-1500 mg/d), sertraline (50-100 mg/d) as active comparator, or placebo. Plasma was available from 292 patients (86% of randomized). Samples from the placebo and H. perforatum groups were assayed for hyperforin, and samples from the sertraline group for sertraline/N-desmethyl-sertraline. Of the 104 patients randomized to placebo, 18 (17%) had detectable plasma hyperforin. Of the 97 patients randomized to H. perforatum, 17 (17%) had no detectable plasma hyperforin. All the assayed sertraline patients (N = 91) had plasma sertraline/N-desmethyl-sertraline. The clinical trial conclusions remained unchanged when only patients with plasma assay consistent with random assignment were included in the analyses. One of every 6 patients assigned to placebo had plasma hyperforin, and 1 of every 6 patients assigned to H. perforatum had no detectable plasma hyperforin. The finding underscores the difficulty of enforcing treatment adherence in clinical trials of preparations that are readily available in the community.

On the design and analysis of clinical trials with correlated outcomes

PubMed Central

Follmann, Dean; Proschan, Michael

2014-01-01

SUMMARY The convention in clinical trials is to regard outcomes as independently distributed, but in some situations they may be correlated. For example, in infectious diseases, correlation may be induced if participants have contact with a common infectious source, or share hygienic tips that prevent infection. This paper discusses the design and analysis of randomized clinical trials that allow arbitrary correlation among all randomized volunteers. This perspective generalizes the traditional perspective of strata, where patients are exchangeable within strata, and independent across strata. For theoretical work, we focus on the test of no treatment effect μ1 − μ0 = 0 when the n dimensional vector of outcomes follows a Gaussian distribution with known n × n covariance matrix Σ, where the half randomized to treatment (placebo) have mean response μ1 (μ0). We show how the new test corresponds to familiar tests in simple situations for independent, exchangeable, paired, and clustered data. We also discuss the design of trials where Σ is known before or during randomization of patients and evaluate randomization schemes based on such knowledge. We provide two complex examples to illustrate the method, one for a study of 23 family clusters with cardiomyopathy, the other where the malaria attack rates vary within households and clusters of households in a Malian village. PMID:25111420

A Randomized Clinical Trial of a Money Management Intervention for Veterans With Psychiatric Disabilities.

PubMed

Elbogen, Eric B; Hamer, Robert M; Swanson, Jeffrey W; Swartz, Marvin S

2016-10-01

The study evaluated an intervention to help veterans with psychiatric disabilities, who face a unique set of challenges concerning money management. A randomized clinical trial was conducted of a brief (one to three hours) psychoeducational, recovery-oriented money management intervention called $teps for Achieving Financial Empowerment ($AFE). Analyses revealed no main effects on outcomes of random assignment to $AFE (N=67) or a control condition consisting of usual care (N=77). Veterans who reported using $AFE skills showed significantly lower impulsive buying, more responsible spending, higher rates of engaging in vocational activities, and greater number of work hours compared with veterans in the control condition. Findings have clinical implications for case management services involving informal money management assistance. Offering veterans with psychiatric disabilities a one-time money management intervention is unlikely to lead to substantial changes. Results imply that efforts to improve psychosocial outcomes among veterans must not only teach but also increase use of money management skills.

Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

PubMed

Raunest, J; Löhnert, J

1990-01-01

A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

Comparative Evaluation of Effect of Nano-hydroxyapatite and 8% Arginine Containing Toothpastes in Managing Dentin Hypersensitivity: Double Blind Randomized Clinical Trial.

PubMed

Anand, Suresh; Rejula, Fathima; Sam, Joseph V G; Christaline, Ramakrishnan; Nair, Mali G; Dinakaran, Shiji

This double blind randomized clinical trial was conducted with the purpose of evaluating the effects of Nano-hydroxyapatite toothpaste as compared to 8% Arginine containing toothpaste in the management of Dentin hypersensitivity (DH). Patients (30 in each group) suffering from DH and eliciting a VAS score higher than 2 in air blast and tactile test were randomly allocated (block randomization) into either a group 1 (arginine toothpaste) or group 2 (nHA toothpaste). The primary outcome evaluated was the reduction of DH as measured by the electrical stimulus reading on the digital pulp tester. Current required for eliciting a VAS score of 2 was recorded before application of dentifrice. 1 cm of toothpaste was then expressed on the tooth surface for two minutes in each group and rinsed off. The electrical stimulus required to elicit a VAS score of 2 was recorded after 5 minutes, 1 week and 4 weeks. The desensitizing paste containing arginine provided a statistically significant reduction in DH and so did the paste containing nHA. Mean increase in amperage value (reduction in DH) was higher for nHA based than the arginine containing dentifrice. This difference was not statistically significant showing that both toothpastes are equally effective. The findings of the present study encourage the use of Nano-hydroxyapatite and arginine containing dentifrice as an effective desensitizing agent providing relief from symptoms 5 minutes after application and after 1 and 4 weeks.

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

PubMed

Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

2015-03-01

ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

Designing and evaluating the effectiveness of a serious game for safe administration of blood transfusion: A randomized controlled trial.

PubMed

Tan, Apphia Jia Qi; Lee, Cindy Ching Siang; Lin, Patrick Yongxing; Cooper, Simon; Lau, Lydia Siew Tiang; Chua, Wei Ling; Liaw, Sok Ying

2017-08-01

Preparing nursing students for the knowledge and skills required for the administration and monitoring of blood components is crucial for entry into clinical practice. Serious games create opportunities to develop this competency, which can be used as a self-directed learning strategy to complement existing didactic learning and simulation-based strategies. To describe the development and evaluation of a serious game to improve nursing students' knowledge, confidence, and performance in blood transfusion. An experiential gaming model was applied to guide the design of the serious game environment. A clustered, randomized controlled trial was conducted with 103 second-year undergraduate nursing students who were randomized into control or experimental groups. After a baseline evaluation of the participants' knowledge and confidence on blood transfusion procedure, the experimental group undertook a blood transfusion serious game and completed a questionnaire to evaluate their learning experience. All participants' clinical performances were evaluated in a simulated environment. The post-test knowledge and confidence mean scores of the experimental group improved significantly (p<0.001) after the serious game intervention compared to pre-test mean scores and to post-test mean scores of the control group (p<0.001). However, no significance difference (p=0.11) was found between the experimental and control groups on the post-test performance mean scores. The participants evaluated the serious game positively. The study provided evidence on the effectiveness of a serious game in improving the knowledge and confidence of nursing students on blood transfusion practice. The features of this serious game could be further developed to incorporate additional scenarios with repetitive exercises and feedback to enhance the impact on clinical performance. Given the flexibility, practicality, and scalability of such a game, they can serve as a promising approach to optimize learning when blended with high-fidelity simulation. Copyright © 2017. Published by Elsevier Ltd.

Explanatory Versus Pragmatic Trials: An Essential Concept in Study Design and Interpretation.

PubMed

Merali, Zamir; Wilson, Jefferson R

2017-11-01

Randomized clinical trials often represent the highest level of clinical evidence available to evaluate the efficacy of an intervention in clinical medicine. Although the process of randomization serves to maximize internal validity, the external validity, or generalizability, of such studies depends on several factors determined at the design phase of the trial including eligibility criteria, study setting, and outcomes of interest. In general, explanatory trials are optimized to demonstrate the efficacy of an intervention in a highly selected patient group; however, findings from these studies may not be generalizable to the larger clinical problem. In contrast, pragmatic trials attempt to understand the real-world benefit of an intervention by incorporating design elements that allow for greater generalizability and clinical applicability of study results. In this article we describe the explanatory-pragmatic continuum for clinical trials in greater detail. Further, a well-accepted tool for grading trials on this continuum is described, and applied, to 2 recently published trials pertaining to the surgical management of lumbar degenerative spondylolisthesis.

Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol

PubMed Central

2014-01-01

Background New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. Methods/Design A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. Discussion Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. Trial registration Clinical Trials.gov Identifier: NCT02016014 PMID:24628961

Efficacy and safety of maropitant, a selective neurokinin 1 receptor antagonist, in two randomized clinical trials for prevention of vomiting due to motion sickness in dogs.

PubMed

Conder, G A; Sedlacek, H S; Boucher, J F; Clemence, R G

2008-12-01

Maropitant (Cerenia), a selective neurokinin(1) receptor antagonist, was evaluated for efficacy and safety in prevention of vomiting due to motion sickness in dogs in two randomized clinical trials. One-hundred eighty-nine dogs with a history of motion sickness were enrolled at 26 veterinary clinics (across 12 US states) across the two trials; of these, 163 were fully evaluable, 19 were evaluable only for safety, and seven were not evaluable. Each trial used a two-period crossover design. Each dog was treated orally with placebo or maropitant (minimum dose of 8 mg/kg body weight using unit dosing) tablets at approximately 2 h (Trial 1) or 10 h (Trial 2) before an automobile ride of approximately 60 min, during which dogs were observed for signs of motion sickness. Following a 10-14-day washout period, each dog was administered the opposite treatment and taken for another journey (same route, driver and vehicle). Maropitant reduced the occurrence of vomiting compared to placebo by 86.1% or 76.5% when given approximately 2 or 10 h prior to travel, respectively. No significant clinical signs were observed after maropitant treatment. Maropitant was safe and effective in preventing vomiting due to motion sickness in dogs when administered at a minimum dose of 8 mg/kg body weight as oral tablets 2 or 10 h prior to travel.

The Coping Cat Program for Children with Anxiety and Autism Spectrum Disorder: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

McNally Keehn, Rebecca H.; Lincoln, Alan J.; Brown, Milton Z.; Chavira, Denise A.

2013-01-01

The purpose of this pilot study was to evaluate whether a modified version of the Coping Cat program could be effective in reducing anxiety in children with autism spectrum disorder (ASD). Twenty-two children (ages 8-14; IQ greater than or equal to 70) with ASD and clinically significant anxiety were randomly assigned to 16 sessions of the Coping…

A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers.

PubMed

Serena, Thomas E; Carter, Marissa J; Le, Lam T; Sabo, Matthew J; DiMarco, Daniel T

2014-01-01

Venous leg ulcers produce significant clinical and economic burdens on society and often require advanced wound therapy. The purpose of this multicenter, randomized, controlled study is to evaluate the safety and efficacy of one or two applications of dehydrated human amnion/chorion membrane allograft and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. The primary study outcome was the proportion of patients achieving 40% wound closure at 4 weeks. Of the 84 participants enrolled, 53 were randomized to receive allograft and 31 were randomized to the control group of multilayer compression therapy alone. At 4 weeks, 62% in the allograft group and 32% in the control group showed a greater than 40% wound closure (p = 0.005), thus showing a significant difference between the allograft-treated groups and the multilayer compression therapy alone group at the 4-week surrogate endpoint. After 4 weeks, wounds treated with allograft had reduced in size a mean of 48.1% compared with 19.0% for controls. Venous leg ulcers treated with allograft had a significant improvement in healing at 4 weeks compared with multilayer compression therapy alone. © 2014 by the Wound Healing Society.

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.

PubMed

Arabi, Yaseen; Al-Hameed, Fahad; Burns, Karen E A; Mehta, Sangeeta; Alsolamy, Sami; Almaani, Mohammed; Mandourah, Yasser; Almekhlafi, Ghaleb A; Al Bshabshe, Ali; Finfer, Simon; Alshahrani, Mohammed; Khalid, Imran; Mehta, Yatin; Gaur, Atul; Hawa, Hassan; Buscher, Hergen; Arshad, Zia; Lababidi, Hani; Al Aithan, Abdulsalam; Jose, Jesna; Abdukahil, Sheryl Ann I; Afesh, Lara Y; Dbsawy, Maamoun; Al-Dawood, Abdulaziz

2018-03-15

The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data. ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.

Comparison of the analgesic efficacy of oral ketorolac versus intramuscular tramadol after third molar surgery: A parallel, double-blind, randomized, placebo-controlled clinical trial

PubMed Central

Isiordia-Espinoza, Mario-Alberto; Martinez-Rider, Ricardo; Perez-Urizar, Jose

2016-01-01

Background Preemptive analgesia is considered an alternative for treating the postsurgical pain of third molar removal. The aim of this study was to evaluate the preemptive analgesic efficacy of oral ketorolac versus intramuscular tramadol after a mandibular third molar surgery. Material and Methods A parallel, double-blind, randomized, placebo-controlled clinical trial was carried out. Thirty patients were randomized into two treatment groups using a series of random numbers: Group A, oral ketorolac 10 mg plus intramuscular placebo (1 mL saline solution); or Group B, oral placebo (similar tablet to oral ketorolac) plus intramuscular tramadol 50 mg diluted in 1 mL saline solution. These treatments were given 30 min before the surgery. We evaluated the time of first analgesic rescue medication, pain intensity, total analgesic consumption and adverse effects. Results Patients taking oral ketorolac had longer time of analgesic covering and less postoperative pain when compared with patients receiving intramuscular tramadol. Conclusions According to the VAS and AUC results, this study suggests that 10 mg of oral ketorolac had superior analgesic effect than 50 mg of tramadol when administered before a mandibular third molar surgery. Key words:Ketorolac, tramadol, third molar surgery, pain, preemptive analgesia. PMID:27475688

An evaluation of biodegradable synthetic polyurethane foam in patients following septoplasty: a prospective randomized trial.

PubMed

Yilmaz, Mahmut Sinan; Guven, Mehmet; Elicora, Sultan Sevik; Kaymaz, Recep

2013-01-01

The purpose of this study is to examine the usability of biodegradable synthetic polyurethane foam (BSPF) after septoplasty by comparing it with Merocel and silicone intranasal splints as packing materials in terms of patient comfort and efficiency. A prospective, unmasked, randomized trial. A tertiary referral center. This study was designed to be a prospective, randomized clinical trial. Sixty-eight patients who underwent septoplasty were included in this study. The patients were randomized to receive Merocel, silicone intranasal septal splint (INS), or BSPF after septoplasty. Clinical efficacy on bleeding, pain, and subjective symptoms related to packing materials was evaluated. There was a statistically significant difference between the Merocel group and the other 2 groups in terms of bleeding and adhesion. The average score on the pain scale was 2.47 ± 1.01 for BSPF, 3.68 ± 1.27 for INS, and 6 ± 2.21 for Merocel. Scores on general satisfaction scales were 6.95 ± 1.42 for Merocel, 8.44 ± 2.12 for INS, and 8.28 ± 1.88 for BSPF. The efficacy of BSPF was comparable with that of Merocel and INS. Biodegradable synthetic polyurethane foam significantly reduced pain and patient discomfort during packing and removal, followed by INS, compared with Merocel.

Survival distributions impact the power of randomized placebo-phase design and parallel groups randomized clinical trials.

PubMed

Abrahamyan, Lusine; Li, Chuan Silvia; Beyene, Joseph; Willan, Andrew R; Feldman, Brian M

2011-03-01

The study evaluated the power of the randomized placebo-phase design (RPPD)-a new design of randomized clinical trials (RCTs), compared with the traditional parallel groups design, assuming various response time distributions. In the RPPD, at some point, all subjects receive the experimental therapy, and the exposure to placebo is for only a short fixed period of time. For the study, an object-oriented simulation program was written in R. The power of the simulated trials was evaluated using six scenarios, where the treatment response times followed the exponential, Weibull, or lognormal distributions. The median response time was assumed to be 355 days for the placebo and 42 days for the experimental drug. Based on the simulation results, the sample size requirements to achieve the same level of power were different under different response time to treatment distributions. The scenario where the response times followed the exponential distribution had the highest sample size requirement. In most scenarios, the parallel groups RCT had higher power compared with the RPPD. The sample size requirement varies depending on the underlying hazard distribution. The RPPD requires more subjects to achieve a similar power to the parallel groups design. Copyright © 2011 Elsevier Inc. All rights reserved.

Antibiotics for human toxoplasmosis: a systematic review of randomized trials

PubMed Central

Rajapakse, Senaka; Chrishan Shivanthan, Mitrakrishnan; Samaranayake, Nilakshi; Rodrigo, Chaturaka; Deepika Fernando, Sumadhya

2013-01-01

The efficacy of different treatment regimens in clinical syndromes of toxoplasmosis were assessed by conducting a systematic review of published randomized clinical trials through extensive searches in MEDLINE, EMBASE, and SCOPUS with no date limits, as well as manual review of journals. Outcome measures varied depending on the clinical entity of toxoplasmosis. Risk of bias was evaluated and quality of evidence was graded. Fourteen randomized trials were included of which one was a non-comparative study. One well-designed trial showed that trimethoprim-sulphamethoxazole was more effective than placebo for clinical recovery of toxoplasmic lymphadenopathy in immunocompetent hosts. For toxoplasmic encephalopathy, efficacy of pyrimethamine+sulphadiazine and trimethoprim+sulphamethoxazole were similar, whereas pyrimethamine+sulphadiazine versus pyrimathamine+clindamycin showed no difference, irrespective of the outcome. Intravitreal clindamycin+dexamethasone and conventional treatment with oral pyrimethamine+sulphadiazine had similar efficacy with regard to all outcome measures in ocular toxoplasmosis, and intravitreal therapy was found to be safe. Adverse effects seemed more common with pyrimethamine+sulphadiazine. Most trials for encephalitis and ocular manifestations had a high risk of bias and were of poor methodological quality. There were no trials evaluating drugs for toxoplasmosis in pregnancy, or for congenital toxoplasmosis. Pyrimethamine+sulphadiazine is an effective therapy for treatment of toxoplasmic encephalitis; trimethoprim+sulphamethoxazole and pyrimethamine+clindamycin are possible alternatives. Treatment with either oral or intravitreal antibiotics seems reasonable for ocular toxoplasmosis. Overall, trial evidence for the efficacy of these drugs for toxoplasmosis is poor, and further well-designed trials are needed. PMID:23816507

Evaluation of the effects of a diabetes educational program: a randomized clinical trial.

PubMed

Torres, Heloísa de Carvalho; Pace, Ana Emília; Chaves, Fernanda Figueredo; Velasquez-Melendez, Gustavo; Reis, Ilka Afonso

2018-02-05

Evaluate the effectiveness of a diabetes mellitus educational program in primary health care. This cluster randomized trial was conducted in a sample of 470 people with type 2 diabetes mellitus from eight health units, randomly assigned to two groups: intervention (n = 231) and control (n = 239). The intervention group participated in the educational program composed of three strategies: group education, home visit, and telephone intervention. Simultaneously, the control group was monitored individually. Group monitoring took place over nine months in the year 2012. Clinical evaluations were performed at the initial time (T0), three (T3), six (T6) and nine (T9) months after the beginning of the intervention. After nine months of follow-up, 341 users remained in the study, 171 in the control group and 170 in the intervention group. The average age of users was 60.6 years. In both groups, statistically significant differences were observed in mean HbA1c levels over the follow-up time (p < 0.05). However, the mean HbA1c level at T3, T6 and T9 times were significantly lower among the people in the intervention group (p < 0.05). The educational program model developed was effective to improve the glycemic control of the intervention group participants.

Efficacy of print advertising for a bipolar disorder study.

PubMed

Roy, Sumeet; Patel, Shilpa; Sheehan, Kathy Harnett; Janavs, Juris; Sheehan, David

2008-01-01

Using quality and quantity of responses, this study evaluated the efficacy of advertising in print media for a bipolar disorder clinical trial. We analyzed the corresponding quantity of calls generated and the cost per patient yield at each of the standard study milestones, spending on print advertising. Quality of calls was based on the attrition rates at each of the study stages. Five hundred and twenty-six calls were received over a 28-month period (February 2004 to June 2006). The largest number of calls were received early in the week (Monday, 25.6%; Tuesday, 23.5%; Wednesday, 18.8%), corresponding with increased advertisements toward the end of the previous week. From the total calls received, 17.14% were eligible for a screening visit, 10.28% were randomized, 9.14% were evaluable, and 7% completed the 8-week study. Sixty percent of the subjects who attended the screening visit were randomized and 68.5% of the randomized subjects completed the study. The yield from phone calls responding to print advertising for a bipolar disorder study was 7%, costing $1,330 per evaluable subject and $1,725 per completed subject. These figures may be useful benchmarks in recruitment planning and budgeting for participants in clinical trials on bipolar disorder.

A Hybrid Process Fidelity Assessment in a Home-based Randomized Clinical Trial

PubMed Central

WILDE, MARY H.; LIEBEL, DIANNE; FAIRBANKS, EILEEN; WILSON, PAULA; LASH, MARGARET; SHAH, SHIVANI; McDONALD, MARGARET V.; BRASCH, JUDITH; ZHANG, FENG; SCHEID, EILEEN; McMAHON, JAMES M.

2016-01-01

A process fidelity assessment was conducted as a nested study within a home-based randomized clinical trial teaching self-management to 101 long-term indwelling urinary catheter users in the treatment group. Our hybrid model combined external assessments (outside observations and tape recordings) with internal evaluation methods (through study nurse forms and notes) for a comprehensive process fidelity assessment. Barriers, patient-related issues, and nurse perspectives were identified demonstrating the complexity in home care intervention research. The complementary and synergistic approaches provided in depth information about the context of the delivery and the impact of the intervention on study outcomes. PMID:25894688

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials.

PubMed

Chen, Minghao; Wei, Shiyou; Hu, Junyan; Yuan, Jing; Liu, Fenghua

2017-01-01

The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94-1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06-1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80-1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use.

A pilot study of clinical agreement in cardiovascular preparticipation examinations: how good is the standard of care?

PubMed

O'Connor, Francis G; Johnson, Jeremy D; Chapin, Mark; Oriscello, Ralph G; Taylor, Dean C

2005-05-01

To evaluate the interobserver agreement between physicians regarding a abnormal cardiovascular assessment on athletic preparticipation examinations. Cross-sectional clinical survey. Outpatient Clinic, United States Military Academy, West Point, NY. We randomly selected 101 out of 539 cadet-athletes presenting for a preparticipation examination. Two primary care sports medicine fellows and a cardiologist examined the cadets. After obtaining informed consent from all participants, all 3 physicians separately evaluated all 101 cadets. The physicians recorded their clinical findings and whether they thought further cardiovascular evaluation (echocardiography) was indicated. Rate of referral for further cardiovascular evaluation, clinical agreement between sports medicine fellows, and clinical agreement between sports medicine fellows and the cardiologist. Each fellow referred 6 of the 101 evaluated cadets (5.9%). The cardiologist referred none. Although each fellow referred 6 cadets, only 1 cadet was referred by both. The kappa statistic for clinical agreement between fellows is 0.114 (95% CI, -0.182 to 0.411). There was no clinical agreement between the fellows and the cardiologist. This pilot study reveals a low level of agreement between physicians regarding which athletes with an abnormal examination deserved further testing. It challenges the standard of care and questions whether there is a need for improved technologies or improved training in cardiovascular clinical assessment.

Simulation can contribute a part of cardiorespiratory physiotherapy clinical education: two randomized trials.

PubMed

Blackstock, Felicity C; Watson, Kathryn M; Morris, Norman R; Jones, Anne; Wright, Anthony; McMeeken, Joan M; Rivett, Darren A; O'Connor, Vivienne; Peterson, Raymond F; Haines, Terry P; Watson, Geoffrey; Jull, Gwendolen Anne

2013-02-01

Simulated learning environments (SLEs) are used worldwide in health professional education, including physiotherapy, to train certain attributes and skills. To date, no randomized controlled trial (RCT) has evaluated whether education in SLEs can partly replace time in the clinical environment for physiotherapy cardiorespiratory practice. Two independent single-blind multi-institutional RCTs were conducted in parallel using a noninferiority design. Participants were volunteer physiotherapy students (RCT 1, n = 176; RCT 2, n = 173) entering acute care cardiorespiratory physiotherapy clinical placements. Two SLE models were investigated as follows: RCT 1, 1 week in SLE before 3 weeks of clinical immersion; RCT 2, 2 weeks of interspersed SLE/clinical immersion (equivalent to 1 SLE week) within the 4-week clinical placement. Students in each RCT were stratified on academic grade and randomly allocated to an SLE plus clinical immersion or clinical immersion control group. The primary outcome was competency to practice measured in 2 clinical examinations using the Assessment of Physiotherapy Practice. Secondary outcomes were student perception of experience and clinical educator and patient rating of student performance. There were no significant differences in student competency between the SLE and control groups in either RCT, although students in the interspersed group (RCT 2) achieved a higher score in 5 of 7 Assessment of Physiotherapy Practice standards (all P < 0.05). Students rated the SLE experience positively. Clinical educators and patients reported comparability between groups. An SLE can replace clinical time in cardiorespiratory physiotherapy practice. Part education in the SLE satisfied clinical competency requirements, and all stakeholders were satisfied.

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

PubMed

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

2016-10-01

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

Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial.

PubMed

Fröbert, Ole; Götberg, Matthias; Angerås, Oskar; Jonasson, Lena; Erlinge, David; Engstrøm, Thomas; Persson, Jonas; Jensen, Svend E; Omerovic, Elmir; James, Stefan K; Lagerqvist, Bo; Nilsson, Johan; Kåregren, Amra; Moer, Rasmus; Yang, Cao; Agus, David B; Erglis, Andrejs; Jensen, Lisette O; Jakobsen, Lars; Christiansen, Evald H; Pernow, John

2017-07-01

Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all-cause death, a new AMI, or stent thrombosis at 1 year. The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Analysis of causality from observational studies and its application in clinical research in Intensive Care Medicine.

PubMed

Coscia Requena, C; Muriel, A; Peñuelas, O

2018-02-28

Random allocation of treatment or intervention is the key feature of clinical trials and divides patients into treatment groups that are approximately balanced for baseline, and therefore comparable covariates except for the variable treatment of the study. However, in observational studies, where treatment allocation is not random, patients in the treatment and control groups often differ in covariates that are related to intervention variables. These imbalances in covariates can lead to biased estimates of the treatment effect. However, randomized clinical trials are sometimes not feasible for ethical, logistical, economic or other reasons. To resolve these situations, interest in the field of clinical research has grown in designing studies that are most similar to randomized experiments using observational (i.e. non-random) data. Observational studies using propensity score analysis methods have been increasing in the scientific papers of Intensive Care. Propensity score analyses attempt to control for confounding in non-experimental studies by adjusting for the likelihood that a given patient is exposed. However, studies with propensity indexes may be confusing, and intensivists are not familiar with this methodology and may not fully understand the importance of this technique. The objectives of this review are: to describe the fundamentals of propensity index methods; to present the techniques to adequately evaluate propensity index models; to discuss the advantages and disadvantages of these techniques. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

Evaluating the impact of a pre-rotation workshop on student preparation for clinical advanced pharmacy practice experiences.

PubMed

Medina, Melissa S; Stark, Jennifer E; Vesta, Kimi S; Lockhart, Staci M

2008-10-01

This pilot study was designed to evaluate the impact of a pre-rotation workshop (PRW) on pharmacy students' clinical skills and preparation for clinical Advanced Pharmacy Practice Experiences (APPE) involving direct patient care. Randomized controlled trial of an educational intervention with Institutional Review Board approval. PRW activities designed to simulate rotation activities around five competencies, patient charts, medication histories, SOAP notes, patient presentations, and professionalism. Endpoints were evaluated using clinical rotation preceptors' evaluation of performance and students' performance on objective structured clinical exams (OSCE). Eight fourth-year students and eight GPA matched controls (20% of the total class) were selected to voluntarily participate. The PRW demonstrated a positive impact on students' clinical skills and preparation for rotations by improving OSCE performance. However, no significant differences were found between groups when comparing preceptor evaluations of skills on rotations. These results are limited by the small sample size, potential OSCE "test-wiseness" effects, lack of OSCE evaluator blinding to study groups, potential case specificity effects due to the limited number of cases used on the OSCE and possible lack of sensitivity of the rotation evaluation tool to capture true differences among the experimental and control group participants. The PRW was successful at advancing students' clinical skills and preparation for rotations and may be considered as a tool to help bridge didactic to clinical experiences in the Pharm.D. curriculum.

Performance of zirconia ceramic cantilever fixed dental prostheses: 3-year results from a prospective, randomized, controlled pilot study.

PubMed

Zenthöfer, Andreas; Ohlmann, Brigitte; Rammelsberg, Peter; Bömicke, Wolfgang

2015-07-01

Little is known about the clinical performance of ceramic cantilever fixed dental prostheses on natural teeth. The purpose of this randomized controlled pilot study was to evaluate the clinical performance of ceramic and metal ceramic cantilever fixed dental prostheses (CFDPs) after 3 years of service. Twenty-one participants were randomly allocated to 2 treatment groups. Participants in the ceramic (ZC) group (n=11) each received 1 CFDP made of yttria-stabilized, tetragonal zirconia polycrystal; the others (n=10) were fitted with a metal ceramic (MC) CFDP. All CFDPs were retained by 2 complete crown abutments and replaced 1 tooth. The clinical target variables were survival, incidence of complications, probing pocket depth (PPD), probing attachment level (PAL), plaque index (PI), gingival index (GI), and esthetic performance as rated by the participants. The United States Public Health Service (USPHS) criteria were used to evaluate chipping, retention, color, marginal integrity, and secondary caries. Descriptive statistics and nonparametric analyses were applied to the target variables in the 2 groups. The esthetic performance of the CFDPs was also visualized by using a pyramid comparison. The overall survival of the CFDPs was 100% in both groups. During the 3-year study, 6 clinically relevant complications requiring aftercare were observed among 5 participants (4 in the ZC group and 2 in the MC group). Changes in the PI, GI, PPD, and PAL of the abutment teeth were similar for both groups (P>.05). The participants regarded the esthetic performance of ZC-CFDPs and MC-CFDPs as satisfactory. Within the 3-year observation period, the clinical performance of MC-FDPs and ZC-FDPs was acceptable. More extensive research with larger sample sizes is encouraged, however, to confirm the evaluation of the survival of Y-TZP hand-veneered cantilever FPDs. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Measuring Workload Demand of Informatics Systems with the Clinical Case Demand Index

PubMed Central

Iyengar, M. Sriram; Rogith, Deevakar; Florez-Arango, Jose F

2017-01-01

Introduction: The increasing use of Health Information Technology (HIT) can add substantially to workload on clinical providers. Current methods for assessing workload do not take into account the nature of clinical cases and the use of HIT tools while solving them. Methods: The Clinical Case Demand Index (CCDI), consisting of a summary score and visual representation, was developed to meet this need. Consistency with current perceived workload measures was evaluated in a Randomized Control Trial of a mobile health system. Results: CCDI is significantly correlated with existing workload measures and inversely related to provider performance. Discussion: CCDI combines subjective and objective characteristics of clinical cases along with cognitive and clinical dimensions. Applications include evaluation of HIT tools, clinician scheduling, medical education. Conclusion: CCDI supports comparative effectiveness research of HIT tools. In addition, CCDI could have numerous applications including training, clinical trials, design of clinical workflows, and others. PMID:29854166

Site matters: multisite randomized trial of motivational enhancement therapy in community drug abuse clinics.

PubMed

Ball, Samuel A; Martino, Steve; Nich, Charla; Frankforter, Tami L; Van Horn, Deborah; Crits-Christoph, Paul; Woody, George E; Obert, Jeanne L; Farentinos, Christiane; Carroll, Kathleen M

2007-08-01

The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. There were no retention differences between the 2 brief intervention conditions. Although both 3-session interventions resulted in reductions in substance use during the 4-week therapy phase, MET resulted in sustained reductions during the subsequent 12 weeks whereas CAU was associated with significant increases in substance use over this follow-up period. This finding was complicated by program site main effects and higher level interactions. MET resulted in more sustained substance use reductions than CAU among primary alcohol users, but no difference was found for primary drug users. An independent evaluation of session audiotapes indicated that MET and CAU were highly and comparably discriminable across sites.

Principles and strategies for monitoring data collection integrity in a multi-site randomized clinical trial of a behavioral intervention.

PubMed

Phillips-Salimi, Celeste R; Donovan Stickler, Molly A; Stegenga, Kristin; Lee, Melissa; Haase, Joan E

2011-08-01

Although treatment fidelity strategies for enhancing the integrity of behavioral interventions have been well described, little has been written about monitoring data collection integrity. This article describes the principles and strategies developed to monitor data collection integrity of the "Stories and Music for Adolescent/Young Adult Resilience During Transplant" study (R01NR008583, U10CA098543, and U10CA095861)-a multi-site Children's Oncology Group randomized clinical trial of a music therapy intervention for adolescents and young adults undergoing stem cell transplant. The principles and strategies outlined in this article provide one model for development and evaluation of a data collection integrity monitoring plan for behavioral interventions that may be adapted by investigators and may be useful to funding agencies and grant application reviewers in evaluating proposals. Copyright © 2011 Wiley Periodicals, Inc.

Design of a cluster-randomized minority recruitment trial: RECRUIT.

PubMed

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

2017-06-01

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 greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

Results from the Xylitol for Adult Caries Trial (X-ACT)

PubMed Central

Bader, James D.; Vollmer, William M.; Shugars, Daniel A.; Gilbert, Gregg H.; Amaechi, Bennett T.; Brown, John P.; Laws, Reesa L.; Funkhouser, Kimberly A.; Makhija, Sonia K.; Ritter, André V.; Leo, Michael C.

2013-01-01

Background Although caries is prevalent in adults, few preventive therapies have been tested in adult populations. This randomized clinical trial evaluated the effectiveness of xylitol lozenges in preventing caries in elevated caries-risk adults. Methods X-ACT was a three-site placebo-controlled randomized trial. Participants (n=691) ages 21–80 consumed five 1.0 g xylitol or placebo lozenges daily for 33 months. Clinical examinations occurred at baseline, 12, 24 and 33 months. Results Xylitol lozenges reduced the caries increment 11%. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect. Conclusions Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among elevated caries-risk adults. Clinical Implications These results suggest that xylitol used as a supplement in adults does not significantly reduce their caries experience. PMID:23283923

Evidence-Based Parenting Interventions to Promote Secure Attachment

PubMed Central

Wright, Barry; Edginton, Elizabeth

2016-01-01

Various interventions are used in clinical practice to address insecure or disorganized attachment patterns and attachment disorders. The most common of these are parenting interventions, but not all have a robust empirical evidence base. We undertook a systematic review of randomized trials comparing a parenting intervention with a control, where these used a validated attachment instrument, in order to evaluate the clinical and cost-effectiveness of interventions aiming to improve attachment in children with severe attachment problems (mean age <13 years). This article aims to inform clinicians about the parenting interventions included in our systematic review that were clinically effective in promoting secure attachment. For completeness, we also briefly discuss other interventions without randomized controlled trial evidence, identified in Patient Public Involvement workshops and expert groups at the point our review was completed as being used or recommended. We outline the key implications of our findings for clinical practice and future research. PMID:27583298

Randomised Clinical Efficacy Trial of Topiramate and Nitrazepam in Treatment of Infantile Spasms

PubMed Central

FALLAH, Razieh; SALOR, Fahimah; AKHAVAN KARBASI, Sedighah; MOTAGHIPISHEH, Hadi

2014-01-01

Objective Infantile spasms (IS) are among the most catastrophic epileptic syndromes of infancy. The purpose of this study was to compare efficacy and safety of topiramate (TPM) and nitrazepam (NZP) as first-line drugs in the treatment of IS. Materials & Methods In a parallel single-blinded randomized clinical trial, 50 patients with IS referred to Pediatric Neurology Clinic of Shahid Sadoughi University of Medical Sciences, Yazd, Iran, were evaluated from September 2008 to March 2010. Patients were randomly assigned to two groups to be treated with TPM or with NZP for 6 months. The primary endpoint was efficacy in cessation of all spasms or reduction of more than 50% in weekly seizure frequency, which was evaluated before and 6 months after the drug use. Secondary outcome was clinical sideeffects of the drugs. Results Twenty boys (40%) and 30 girls (60%) with the mean age of 9.4±3.8 months were evaluated. Cessation of all spasms occurred in 12 (48%) infants in TPM group and 4(16%) in NZP group. Eight (32%) children in TPM group and 7 (28%) in NZP group had more than 50% reduction in spasms frequency. So, TPM was more effective. Side effects were seen in 32% of TPM and in 36% of NZP groups. Conclusion Topiramate is an effective and safe drug, which might be considered as the firstline drug for the treatment of ISs. PMID:24665322

Evaluation of the efficacy of a topical sialogogue spray containing malic acid 1% in elderly people with xerostomia: a double-blind, randomized clinical trial.

PubMed

Gómez-Moreno, Gerardo; Cabrera-Ayala, Maribel; Aguilar-Salvatierra, Antonio; Guardia, Javier; Ramírez-Fernández, María Piedad; González-Jaranay, Maximino; Calvo-Guirado, José Luis

2014-12-01

The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid for elderly people affected by xerostomia. This research took the form of a double-blind, randomized clinical trial. Forty-one individuals (mean age: 78.7 years) with xerostomia were divided into two groups: for the first 'intervention group' (21 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second 'control group' (20 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The Xerostomia Inventory (XI) was used to evaluate xerostomia levels before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after spray application, were measured. XI scores decreased significantly (clinically meaningful) from 36.4 ± 7.3 points to 29.1 ± 7.1 (p < 0.05) with an XI difference of 7.2 ± 6.1, after the combination among 1% malic acid with xylitol and fluoride application. After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < 0.05). A topical sialogogue spray containing 1% malic acid improved xerostomia in an elderly population and increased unstimulated and stimulated salivary flows rates. © 2013 The Gerodontology Society and John Wiley & Sons A/S.

78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... methodological issues that arise in the use of meta-analyses to evaluate safety risks, followed by a discussion... design, conduct and use of meta-analysis. Although many external stakeholders conduct meta-analyses, FDA... meeting. FDA expects that this meeting will build upon prior stakeholder feedback on the design, conduct...

Outcome evaluation of Family Eats: An eight-session web-based program promoting healthy home food environments and dietary behaviors for African American families

USDA-ARS?s Scientific Manuscript database

This article presents the results of a randomized clinical trial evaluating the eight-session Family Eats web-based intervention promoting healthy home food environments for African American families. African American families (n=126) with 8- to 12-year-old children completed online baseline questio...

Evidence-Based Medicine and Child Mental Health Services: A Broad Approach to Evaluation is Needed.

ERIC Educational Resources Information Center

McGuire, Jacqueline Barnes; And Others

1997-01-01

Describes quasi-experimental designs to be used as alternatives to randomized controlled trials in decisions concerning clinical practice and policy-making in the child mental health field. Highlights importance of taking a systems-level approach to evaluation, and describes ways in which qualitative outcomes measures can be used to sensitively…

Improving the Reporting Quality of Nonrandomized Evaluations of Behavioral and Public Health Interventions: The TREND Statement

PubMed Central

Des Jarlais, Don C.; Lyles, Cynthia; Crepaz, Nicole

2004-01-01

Developing an evidence base for making public health decisions will require using data from evaluation studies with randomized and nonrandomized designs. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study, with sufficient detail and clarity to readily see differences and similarities among studies in the same area. The Consolidated Standards of Reporting Trials (CONSORT) statement provides guidelines for transparent reporting of randomized clinical trials. We present the initial version of the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement. These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions, research design, and methods of adjusting for possible biases in evaluation studies that use nonrandomized designs. PMID:14998794

Minocycline and matrix metalloproteinase inhibition in acute intracerebral hemorrhage: a pilot study.

PubMed

Chang, J J; Kim-Tenser, M; Emanuel, B A; Jones, G M; Chapple, K; Alikhani, A; Sanossian, N; Mack, W J; Tsivgoulis, G; Alexandrov, A V; Pourmotabbed, T

2017-11-01

Intracerebral hemorrhage (ICH) is a devastating cerebrovascular disorder with high morbidity and mortality. Minocycline is a matrix metalloproteinase-9 (MMP-9) inhibitor that may attenuate secondary mechanisms of injury in ICH. The feasibility and safety of minocycline in ICH patients were evaluated in a pilot, double-blinded, placebo-controlled randomized clinical trial. Patients with acute onset (<12 h from symptom onset) ICH and small initial hematoma volume (<30 ml) were randomized to high-dose (10 mg/kg) intravenous minocycline or placebo. The outcome events included adverse events, change in serial National Institutes of Health Stroke Scale score assessments, hematoma volume and MMP-9 measurements, 3-month functional outcome (modified Rankin score) and mortality. A total of 20 patients were randomized to minocycline (n = 10) or placebo (n = 10). The two groups did not differ in terms of baseline characteristics. No serious adverse events or complications were noted with minocycline infusion. The two groups did not differ in any of the clinical and radiological outcomes. Day 5 serum MMP-9 levels tended to be lower in the minocycline group (372 ± 216 ng/ml vs. 472 ± 235 ng/ml; P = 0.052). Multiple linear regression analysis showed that minocycline was associated with a 217.65 (95% confidence interval -425.21 to -10.10, P = 0.041) decrease in MMP-9 levels between days 1 and 5. High-dose intravenous minocycline can be safely administered to patients with ICH. Larger randomized clinical trials evaluating the efficacy of minocycline and MMP-9 inhibition in ICH patients are required. © 2017 EAN.

Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): rationale and study design of the randomized TWENTE III multicenter trial.

PubMed

Lam, Ming Kai; Sen, Hanim; Tandjung, Kenneth; van Houwelingen, K Gert; de Vries, Arie G; Danse, Peter W; Schotborgh, Carl E; Scholte, Martijn; Löwik, Marije M; Linssen, Gerard C M; Ijzerman, Maarten J; van der Palen, Job; Doggen, Carine J M; von Birgelen, Clemens

2014-04-01

To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES. BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non-inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012. BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome. Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.

The Role of Eye Movement Desensitization and Reprocessing (EMDR) Therapy in Medicine: Addressing the Psychological and Physical Symptoms Stemming from Adverse Life Experiences

PubMed Central

Shapiro, Francine

2014-01-01

Background: A substantial body of research shows that adverse life experiences contribute to both psychological and biomedical pathology. Eye movement desensitization and reprocessing (EMDR) therapy is an empirically validated treatment for trauma, including such negative life experiences as commonly present in medical practice. The positive therapeutic outcomes rapidly achieved without homework or detailed description of the disturbing event offer the medical community an efficient treatment approach with a wide range of applications. Methods: All randomized studies and significant clinical reports related to EMDR therapy for treating the experiential basis of both psychological and somatic disorders are reviewed. Also reviewed are the recent studies evaluating the eye movement component of the therapy, which has been posited to contribute to the rapid improvement attributable to EMDR treatment. Results: Twenty-four randomized controlled trials support the positive effects of EMDR therapy in the treatment of emotional trauma and other adverse life experiences relevant to clinical practice. Seven of 10 studies reported EMDR therapy to be more rapid and/or more effective than trauma-focused cognitive behavioral therapy. Twelve randomized studies of the eye movement component noted rapid decreases in negative emotions and/or vividness of disturbing images, with an additional 8 reporting a variety of other memory effects. Numerous other evaluations document that EMDR therapy provides relief from a variety of somatic complaints. Conclusion: EMDR therapy provides physicians and other clinicians with an efficient approach to address psychological and physiologic symptoms stemming from adverse life experiences. Clinicians should therefore evaluate patients for experiential contributors to clinical manifestations. PMID:24626074

Two-year Randomized Clinical Trial of Self-etching Adhesives and Selective Enamel Etching.

PubMed

Pena, C E; Rodrigues, J A; Ely, C; Giannini, M; Reis, A F

2016-01-01

The aim of this randomized, controlled prospective clinical trial was to evaluate the clinical effectiveness of restoring noncarious cervical lesions with two self-etching adhesive systems applied with or without selective enamel etching. A one-step self-etching adhesive (Xeno V(+)) and a two-step self-etching system (Clearfil SE Bond) were used. The effectiveness of phosphoric acid selective etching of enamel margins was also evaluated. Fifty-six cavities were restored with each adhesive system and divided into two subgroups (n=28; etch and non-etch). All 112 cavities were restored with the nanohybrid composite Esthet.X HD. The clinical effectiveness of restorations was recorded in terms of retention, marginal integrity, marginal staining, caries recurrence, and postoperative sensitivity after 3, 6, 12, 18, and 24 months (modified United States Public Health Service). The Friedman test detected significant differences only after 18 months for marginal staining in the groups Clearfil SE non-etch (p=0.009) and Xeno V(+) etch (p=0.004). One restoration was lost during the trial (Xeno V(+) etch; p>0.05). Although an increase in marginal staining was recorded for groups Clearfil SE non-etch and Xeno V(+) etch, the clinical effectiveness of restorations was considered acceptable for the single-step and two-step self-etching systems with or without selective enamel etching in this 24-month clinical trial.

Clinical Equipoise and Shared Decision-making in Pulmonary Nodule Management. A Survey of American Thoracic Society Clinicians.

PubMed

Iaccarino, Jonathan M; Simmons, James; Gould, Michael K; Slatore, Christopher G; Woloshin, Steven; Schwartz, Lisa M; Wiener, Renda Soylemez

2017-06-01

Guidelines for pulmonary nodule evaluation suggest a variety of strategies, reflecting the lack of high-quality evidence demonstrating the superiority of any one approach. It is unclear whether clinicians agree that multiple management options are appropriate at different levels of risk and whether this impacts their decision-making approaches with patients. To assess clinicians' perceptions of the appropriateness of various diagnostic strategies, approach to decision-making, and perceived clinical equipoise in pulmonary nodule evaluation. We developed and administered a web-based survey in March and April, 2014 to clinician members of the American Thoracic Society. The primary outcome was perceived appropriateness of pulmonary nodule evaluation strategies in three clinical vignettes with different malignancy risk. We compared responses to guideline recommendations and analyzed clinician characteristics associated with a reported shared decision-making approach. We also assessed clinicians' likelihood to enroll patients in hypothetical randomized trials comparing nodule evaluation strategies. Of 5,872 American Thoracic Society members e-mailed, 1,444 opened the e-mail and 428 eligible clinicians participated in the survey (response rate, 30.0% among those who opened the invitation; 7% overall). The mean number of options considered appropriate increased with pretest probability of cancer, ranging from 1.8 (SD, 1.2) for the low-risk case to 3.5 (1.1) for the high-risk case (P < 0.0001). As recommended by guidelines, the proportion that deemed surgical resection as an appropriate option also increased with cancer risk (P < 0.0001). One-half of clinicians (50.4%) reported engaging in shared decision-making with patients for pulmonary nodule management; this was more commonly reported by clinicians with more years of experience (P = 0.01) and those who reported greater comfort in managing pulmonary nodules (P = 0.005). Although one-half (49.9%) deemed the evidence for pulmonary nodule evaluation to be strong, most clinicians were willing to enroll patients in randomized trials to compare nodule management strategies in all risk categories (low risk, 87.6%; moderate risk, 89.7%; high risk, 63.0%). Consistent with guideline recommendations, clinicians embrace multiple options for pulmonary nodule evaluation and many are open to shared decision-making. Clinicians support the need for randomized clinical trials to strengthen the evidence for nodule evaluation, which will further improve decision-making.

Evaluating information prescriptions in two clinical environments*

PubMed Central

Oliver, Kathleen Burr; Lehmann, Harold P; Wolff, Antonio C; Davidson, Laurie W; Donohue, Pamela K; Gilmore, Maureen M; Craven, Catherine K.

2011-01-01

Objective: The research sought to evaluate whether providing personalized information services by libraries can improve satisfaction with information services for specific types of patients. Methods: Adult breast cancer (BrCa) clinic patients and mothers of inpatient neonatal intensive care unit (NICU) patients were randomized to receive routine information services (control) or an IRx intervention. Results: The BrCa trial randomized 211 patients and the NICU trial, 88 mothers. The BrCa trial showed no statistically significant differences in satisfaction ratings between the treatment and control groups. The IRx group in the NICU trial reported higher satisfaction than the control group regarding information received about diagnosis, treatments, respiratory tradeoffs, and medication tradeoffs. BrCa patients posed questions to librarians more frequently than did NICU mothers, and a higher percentage reported using the website. Questions asked of the librarians by BrCa patients were predominantly clinical and focused on the areas of treatment and side effects. Conclusions: Study results provide some evidence to support further efforts to both implement information prescription projects in selected settings and to conduct additional research on the costs and benefits of services. PMID:21753916

Psychological, behavioral, and clinical effects of intra-oral camera: a randomized control trial on adults with gingivitis.

PubMed

Araújo, Mário-Rui; Alvarez, Maria-João; Godinho, Cristina A; Pereira, Cícero

2016-12-01

To evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral, and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework. A group of 78 adult patients with gingivitis receiving an SPT was randomized into two groups: IOC and control. Bleeding on Marginal Probing (BOMP), self-reported dental hygiene behaviors, and psychological determinants of behavior change (outcome expectancies, self-efficacy, and planning) and IOC opinion were evaluated 1 week before or during the appointment and 4 months later. Repeated-measures anova was used to compare groups over time. Almost all the patients brushed their teeth daily, while 78% either never or hardly ever used dental floss. The IOC group showed significant improvements in BOMP index (P < 0.001), self-reported flossing (P < 0.05), and self-efficacy (P < 0.05) compared to the control group. The use of IOC significantly improves clinical, behavioral, and psychological determinants of periodontal health 4 months after treatment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Addressing the expected survival benefit for clinical trial design in metastatic castration-resistant prostate cancer: Sensitivity analysis of randomized trials.

PubMed

Massari, Francesco; Modena, Alessandra; Ciccarese, Chiara; Pilotto, Sara; Maines, Francesca; Bracarda, Sergio; Sperduti, Isabella; Giannarelli, Diana; Carlini, Paolo; Santini, Daniele; Tortora, Giampaolo; Porta, Camillo; Bria, Emilio

2016-02-01

We performed a sensitivity analysis, cumulating all randomized clinical trials (RCTs) in which patients with metastatic castration-resistant prostate cancer (mCRPC) received systemic therapy, to evaluate if the comparison of RCTs may drive to biased survival estimations. An overall survival (OS) significant difference according to therapeutic strategy was more likely be determined in RCTs evaluating hormonal drugs versus those studies testing immunotherapy, chemotherapy or other strategies. With regard to control arm, an OS significant effect was found for placebo-controlled trials versus studies comparing experimental treatment with active therapies. Finally, regarding to docetaxel (DOC) timing, the OS benefit was more likely to be proved in Post-DOC setting in comparison with DOC and Pre-DOC. These data suggest that clinical trial design should take into account new benchmarks such as the type of treatment strategy, the choice of the comparator and the phase of the disease in relation to the administration of standard chemotherapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial.

PubMed

Zhang, Ying; Sun, Jin; Zhang, Yun-Jiao; Chai, Qian-Yun; Zhang, Kang; Ma, Hong-Li; Wu, Xiao-Ke; Liu, Jian-Ping

2016-10-21

Although Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP). The trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting. We specified detailed methods for data management and statistical analyses. Statistics in corresponding tables, listings, and graphs were outlined. The SAP provided more detailed information than trial protocol on data management and statistical analysis methods. Any post hoc analyses could be identified via referring to this SAP, and the possible selection bias and performance bias will be reduced in the trial. This study is registered at ClinicalTrials.gov, NCT01138930 , registered on 7 June 2010.

Tailoring and evaluating an intervention to improve shared decision-making among seniors with dementia, their caregivers, and healthcare providers: study protocol for a randomized controlled trial.

PubMed

Giguere, Anik M C; Lawani, Moulikatou Adouni; Fortier-Brochu, Émilie; Carmichael, Pierre-Hugues; Légaré, France; Kröger, Edeltraut; Witteman, Holly O; Voyer, Philippe; Caron, Danielle; Rodríguez, Charo

2018-06-25

The increasing prevalence of Alzheimer's disease and other forms of dementia raises new challenges to ensure that healthcare decisions are informed by research evidence and reflect what is important for seniors and their caregivers. Therefore, we aim to evaluate a tailored intervention to help healthcare providers empower seniors and their caregivers in making health-related decisions. In two phases, we will: (1) design and tailor the intervention; and (2) implement and evaluate it. We will use theory and user-centered design to tailor an intervention comprising a distance professional training program on shared decision-making and five shared decision-making tools dealing with difficult decisions often faced by seniors with dementia and their caregivers. Each tool will be designed in two versions, one for clinicians and one for patients. We will recruit 49 clinicians and 27 senior/caregiver to participate in three cycles of design-evaluation-feedback of each intervention components. Besides think-aloud and interview approaches, users will also complete questionnaires based on the Theory of Planned Behavior to identify the factors most likely to influence their adoption of shared decision-making after exposure to the intervention. We will then modify the intervention by adding/enhancing behavior-change techniques targeting these factors. We will evaluate the effectiveness of this tailored intervention before/after implementation, in a two-armed, clustered randomized trial. We will enroll a convenience sample of six primary care clinics (unit of randomization) in the province of Quebec and recruit the clinicians who practice there (mostly family physicians, nurses, and social workers). These clinics will then be randomized to immediate exposure to the intervention or delayed exposure. Overall, we will recruit 180 seniors with dementia, their caregivers, and their healthcare providers. We will evaluate the impact of the intervention on patient involvement in the decision-making process, decisional comfort, patient and caregiver personal empowerment in relation to their own healthcare, patient quality of life, caregiver burden, and decisional regret. The intervention will empower patients and their caregivers in their healthcare, by fostering their participation as partners during the decision-making process and by ensuring they make informed decisions congruent with their values and priorities. ClinicalTrials.org, NCT02956694 . Registered on 31 October 2016.

A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥ 12 years with tinea cruris.

PubMed

Jones, Terry M; Jarratt, Michael T; Mendez-Moguel, Ines; Paz, Nelly; Grekin, Steven K; Cognata Smith, Christina; Kaur, Mandeep

2014-01-01

Tinea cruris, a pruritic superficial fungal infection of the groin, is the second most common clinical presentation for dermatophytosis. This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris. 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days. Efficacy was evaluated at baseline and at days 7, 14, 21, and 28 based on mycology (potassium hydroxide, fungal culture) and clinical signs (erythema, scaling, pruritus). The primary outcome was complete clearance at day 28 (21 days posttreatment). Safety evaluations included adverse events and laboratory assessments. Complete clearance was obtained in 21.2% (35/165) of patients treated with luliconazole cream 1% compared with 4.4% (4/91) treated with vehicle (P<0.001). The safety profile of luliconazole cream 1% was similar to vehicle. The study was conducted under controlled conditions in a relatively small population. Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.

Antibiotic prophylaxis in hematopoietic stem cell transplantation. A meta-analysis of randomized controlled trials.

PubMed

Kimura, Shun-ichi; Akahoshi, Yu; Nakano, Hirofumi; Ugai, Tomotaka; Wada, Hidenori; Yamasaki, Ryoko; Ishihara, Yuko; Kawamura, Koji; Sakamoto, Kana; Ashizawa, Masahiro; Sato, Miki; Terasako-Saito, Kiriko; Nakasone, Hideki; Kikuchi, Misato; Yamazaki, Rie; Kako, Shinichi; Kanda, Junya; Tanihara, Aki; Nishida, Junji; Kanda, Yoshinobu

2014-07-01

We performed a meta-analysis to evaluate the impact of systemic antibiotic prophylaxis in hematopoietic stem cell transplantation (HSCT) recipients. We collected reports from PubMed, the Cochrane Library, EMBASE, CINAHL, and Web of Science, along with references cited therein. We included prospective, randomized studies on systemic antibiotic prophylaxis in HSCT recipients. Seventeen trials with 1453 autologous and allogeneic HSCT recipients were included. Systemic antibiotic prophylaxis was compared with placebo or no prophylaxis in 10 trials and with non-absorbable antibiotics in two trials. Systemic antibiotics other than fluoroquinolones were evaluated in five of these 12 trials. Four trials evaluated the effect of the addition of antibiotics for gram-positive bacteria to fluoroquinolones. One trial compared two different systemic antibiotic regimens: fluoroquinolones versus trimethoprim-sulfamethoxazole. As a result, systemic antibiotic prophylaxis reduced the incidence of febrile episodes (OR 0.16; 95%CI 0.09-0.30), clinically or microbiologically documented infection (OR 0.38; 95%CI 0.22-0.63) and bacteremia (OR 0.31; 95%CI 0.16-0.59) without significantly affecting all-cause mortality or infection-related mortality. Systemic antibiotic prophylaxis successfully reduced the incidence of infection. However, there was no significant impact on mortality. The clinical benefits of prophylaxis with fluoroquinolones were inconclusive because of the small number of clinical trials evaluated. Copyright © 2014 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

Safety and tolerability of adjunctive rosiglitazone treatment for children with uncomplicated malaria.

PubMed

Varo, Rosauro; Crowley, Valerie M; Sitoe, Antonio; Madrid, Lola; Serghides, Lena; Bila, Rubao; Mucavele, Helio; Mayor, Alfredo; Bassat, Quique; Kain, Kevin C

2017-05-23

Despite the widespread use and availability of rapidly acting anti-malarials, the fatality rate of severe malaria in sub-Saharan Africa remains high. Adjunctive therapies that target the host response to malaria infection may further decrease mortality over that of anti-malarial agents alone. Peroxisome proliferator-activated receptor-gamma agonists (e.g. rosiglitazone) have been shown to act on several pathways implicated in the pathogenesis of severe malaria and may improve clinical outcome as an adjunctive intervention. In this study, the safety and tolerability of adjunctive rosiglitazone in paediatric uncomplicated malaria infection was evaluated in Mozambique, as a prelude to its evaluation in a randomized controlled trial in paediatric severe malaria. The study was a prospective, randomized, double-blind, placebo-controlled, phase IIa trial of rosiglitazone (0.045 mg/kg/dose) twice daily for 4 days versus placebo as adjunctive treatment in addition to Mozambican standard of care (artemisinin combination therapy Coartem ® ) in children with uncomplicated malaria. The primary outcomes were tolerability and safety, including clinical, haematological, biochemical, and electrocardiographic evaluations. Thirty children were enrolled: 20 were assigned to rosiglitazone and 10 to placebo. Rosiglitazone treatment did not induce hypoglycaemia nor significantly alter clinical, biochemical, haematological, or electrocardiographic parameters. Adjunctive rosiglitazone was safe and well-tolerated in children with uncomplicated malaria, permitting the extension of its evaluation as adjunctive therapy for severe malaria. The trial is registered with Clinicaltrials.gov, NCT02694874.

Treatment of Multiple-Resistant and/or Recurrent Cutaneous Warts With Squaric Acid Dibutylester: A Randomized, Double-blind, Vehicle-controlled Clinical Trial.

PubMed

DallʼOglio, Federica; Luca, Maria; Barresi, Sebastiano; Micali, Giuseppe

Contact immunotherapy with squaric acid dibutylester (SADBE) for cutaneous warts has been reported to be effective, although no controlled studies are available so far. The aim of this study was to evaluate the efficacy of SADBE on cutaneous warts by a randomized, double-blind, vehicle-controlled, clinical trial. Thirty-six patients were randomly assigned to SADBE (18 cases) or vehicle (18 cases) group. At 8 weeks, subjects were clinically evaluated for number/size reduction rate and for Investigator Global Assessment. Those who showed improvement extended therapy up to 40 weeks, whereas those who showed unresponsiveness were either switched to SADBE application for up to 48 weeks (if in the vehicle group) or withdrawn from the study (if under SADBE). At 8 weeks, a significant reduction in wart number (P = 0.020) and size (P = 0.010) in the SADBE group, with clearing rates of 41.2% versus 12.5% in the SADBE and vehicle groups, respectively, was observed. Nine remaining SADBE responders who underwent treatment extension up to 40 weeks achieved clearing versus 2 patients of the vehicle group who remained unresponsive. Clearing was obtained in 81.8% of patients who underwent previous ineffective vehicle treatment and had been switched to SADBE. Squaric acid dibutylester is an effective therapeutic option and is significantly more effective than vehicle.

No difference between fixed- and mobile-bearing total knee arthroplasty in activities of daily living and pain: a randomized clinical trial.

PubMed

Amaro, Joicemar Tarouco; Arliani, Gustavo Gonçalves; Astur, Diego Costa; Debieux, Pedro; Kaleka, Camila Cohen; Cohen, Moises

2017-06-01

Until now, there are no definitive conclusions regarding functional differences related to middle- and long-term everyday activities and patient pain following implantation of mobile- and fixed-platform tibial prostheses. The aim of this study was to determine whether there are middle-term differences in knee function and pain in patients undergoing fixed- and mobile-bearing total knee arthroplasty (TKA). Eligible patients were randomized into two groups: the first group received TKA implantation with a fixed tibial platform (group A); the second group received TKA with a mobile tibial platform (group B). Patients were followed up (2 years), and their symptoms and limitations in daily living activities were evaluated using the Knee Outcome Survey-Activities of Daily Living Scale (ADLS), in addition to pain evaluation assessed using the pain visual analogue scale (VAS). There were no significant differences in function and symptoms in the ADLS and VAS between the study groups. The type of platform used in TKA (fixed vs. mobile) does not change the symptoms, function or pain of patients 2 years post-surgery. Although mobile TKAs may have better short-term results, at medium- and long-term follow-up they do not present important clinical differences compared with fixed-platform TKAs. This information is important so that surgeons can choose the most suitable implant for each patient. Randomized clinical trial, Level I.

Current role of cryotherapy in retinopathy of prematurity: a report by the American Academy of Ophthalmology.

PubMed

Simpson, Jennifer L; Melia, Michele; Yang, Michael B; Buffenn, Angela N; Chiang, Michael F; Lambert, Scott R

2012-04-01

To evaluate the role of cryotherapy in the current treatment of retinopathy of prematurity (ROP). Literature searches of PubMed and the Cochrane Library were conducted on December 2, 2009, for articles published after 1984. The searches included all languages and retrieved 187 relevant citations. Thirteen articles were deemed relevant to the assessment question and were rated according to the strength of evidence. Four articles reported results from 2 large multicenter randomized clinical trials, and the remaining 9 articles reported results of 3 small randomized trials that directly compared cryotherapy and laser. Neither of the multicenter randomized clinical trials was a direct comparison of cryotherapy with laser. These studies were used to evaluate the comparative trials based on treatment criteria, study populations, and clinical results. Higher percentages of poor structural and functional outcomes generally were seen in eyes treated with cryotherapy compared with eyes undergoing laser treatment. Higher rates of systemic complications and myopia also were identified after treatment with cryotherapy. Despite a relative paucity of level I evidence directly comparing cryotherapy and laser treatment for threshold ROP, the literature suggests that neonatal facilities should gain access to laser technology and laser-trained ophthalmic staff to achieve better outcomes for treatment of the disease. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

A multifaceted intervention to narrow the evidence-based gap in the treatment of acute coronary syndromes: rationale and design of the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS) cluster-randomized trial.

PubMed

Berwanger, Otávio; Guimarães, Hélio P; Laranjeira, Ligia N; Cavalcanti, Alexandre B; Kodama, Alessandra; Zazula, Ana Denise; Santucci, Eliana; Victor, Elivane; Flato, Uri A; Tenuta, Marcos; Carvalho, Vitor; Mira, Vera Lucia; Pieper, Karen S; Mota, Luiz Henrique; Peterson, Eric D; Lopes, Renato D

2012-03-01

Translating evidence into clinical practice in the management of acute coronary syndromes (ACS) is challenging. Few ACS quality improvement interventions have been rigorously evaluated to determine their impact on patient care and clinical outcomes. We designed a pragmatic, 2-arm, cluster-randomized trial involving 34 clusters (Brazilian public hospitals). Clusters were randomized to receive a multifaceted quality improvement intervention (experimental group) or routine practice (control group). The 6-month educational intervention included reminders, care algorithms, a case manager, and distribution of educational materials to health care providers. The primary end point was a composite of evidence-based post-ACS therapies within 24 hours of admission, with the secondary measure of major cardiovascular clinical events (death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke). Prescription of evidence-based therapies at hospital discharge were also evaluated as part of the secondary outcomes. All analyses were performed by the intention-to-treat principle and took the cluster design into account using individual-level regression modeling (generalized estimating equations). If proven effective, this multifaceted intervention would have wide use as a means of promoting optimal use of evidence-based interventions for the management of ACS. Copyright © 2012 Mosby, Inc. All rights reserved.

Comparative evaluation of photoablative efficacy of erbium: yttrium-aluminium-garnet and diode laser for the treatment of gingival hyperpigmentation. A randomized split-mouth clinical trial.

PubMed

Giannelli, Marco; Formigli, Lucia; Bani, Daniele

2014-04-01

The use of lasers in periodontology is a matter of debate, mainly because of the lack of consensual therapeutic protocols. In this randomized, split-mouth trial, the clinical efficacy of two different photoablative dental lasers, erbium:yttrium-aluminum-garnet (Er:YAG) and diode, for the treatment of gingival hyperpigmentation is compared. Twenty-one patients requiring treatment for mild-to-severe gingival hyperpigmentation were enrolled. Maxillary or mandibular left or right quadrants were randomly subjected to photoablative deepithelialization with either Er:YAG or diode laser. Masked clinical assessments of each laser quadrant were made at admission and days 7, 30, and 180 postoperatively by an independent observer. Histologic examination was performed before and soon after treatment and 6 months after irradiation. Patients also compiled a subjective evaluation questionnaire. Both diode and Er:YAG lasers gave excellent results in gingival hyperpigmentation. However, Er:YAG laser induced deeper gingival tissue injury than diode laser, as judged by bleeding at surgery, delayed healing, and histopathologic analysis. The use of diode laser showed additional advantages compared to Er:YAG in terms of less postoperative discomfort and pain. This study highlights the efficacy of diode laser for photoablative deepithelialization of hyperpigmented gingiva. It is suggested that this laser can represent an effective and safe therapeutic option for gingival photoablation.

Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial.

PubMed

Jacobs, Jennifer; Williams, Anna-Leila; Girard, Christine; Njike, Valentine Yanchou; Katz, David

2005-10-01

The aim of this study was to carry out a preliminary trial evaluating the effectiveness of homeopathy in the treatment of attention-deficit/hyperactivity disorder (ADHD). This work was a randomized, double-blind, placebo-controlled trial. This study was conducted in a private homeopathic clinic in the Seattle metropolitan area. Subjects included children 6-12 years of age meeting Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for ADHD. Forty-three subjects were randomized to receive a homeopathic consultation and either an individualized homeopathic remedy or placebo. Patients were seen by homeopathic physicians every 6 weeks for 18 weeks. Outcome measures included the Conner's Global Index-Parent, Conner's Global Index- Teacher, Conner's Parent Rating Scale-Brief, Continuous Performance Test, and the Clinical Global Impression Scale. There were no statistically significant differences between homeopathic remedy and placebo groups on the primary or secondary outcome variables. However, there were statistically and clinically significant improvements in both groups on many of the outcome measures. This pilot study provides no evidence to support a therapeutic effect of individually selected homeopathic remedies in children with ADHD. A therapeutic effect of the homeopathic encounter is suggested and warrants further evaluation. Future studies should be carried out over a longer period of time and should include a control group that does not receive the homeopathic consultation. Comparison to conventional stimulant medication for ADHD also should be considered.

Impact of fibrates on circulating cystatin C levels: a systematic review and meta-analysis of clinical trials.

PubMed

Sahebkar, Amirhossein; Simental-Mendía, Luis E; Pirro, Matteo; Montecucco, Fabrizio; Carbone, Federico; Banach, Maciej; Barreto, George E; Butler, Alexandra E

2018-06-29

To assess the effect of fibrates on circulating cystatin C levels. Clinical studies evaluating the effect of a fibrate on circulating cystatin C levels were searched in PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases. A random-effect model and generic inverse variance method were used for quantitative data synthesis, sensitivity analysis conducted using the leave-one-out method, and weighted random-effects meta-regression performed to evaluate potential confounders on cystatin C levels. This meta-analysis of data from 9 published studies (16 treatment arms) involved a total of 2195 subjects. In a single-arm analysis of clinical trials (without control group; 8 studies comprising 14 treatment arms), fibrate therapy increased circulating cystatin C concentrations (WMD: 0.07 mg/dL, 95% CI: 0.04, 0.10, p <0.001; I 2 = 82.66%). When the analysis was restricted to randomized controlled trials (4 studies comprising 6 treatment arms), again elevation of circulating cystatin C levels was observed (WMD: 0.06 mg/L, 95% CI: 0.03, 0.09, p <0.001; I 2 = 42.98%). Elevated cystatin C levels were only seen with fenofibrate, not other fibrates. The results suggest that fenofibrate treatment adversely affects cystatin C levels and might partially explain the limited efficacy of fenofibrate in reducing cardiovascular events.

Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core.

PubMed

Cook, Andrea J; Delong, Elizabeth; Murray, David M; Vollmer, William M; Heagerty, Patrick J

2016-10-01

Pragmatic clinical trials embedded within health care systems provide an important opportunity to evaluate new interventions and treatments. Networks have recently been developed to support practical and efficient studies. Pragmatic trials will lead to improvements in how we deliver health care and promise to more rapidly translate research findings into practice. The National Institutes of Health (NIH) Health Care Systems Collaboratory was formed to conduct pragmatic clinical trials and to cultivate collaboration across research areas and disciplines to develop best practices for future studies. Through a two-stage grant process including a pilot phase (UH2) and a main trial phase (UH3), investigators across the Collaboratory had the opportunity to work together to improve all aspects of these trials before they were launched and to address new issues that arose during implementation. Seven Cores were created to address the various considerations, including Electronic Health Records; Phenotypes, Data Standards, and Data Quality; Biostatistics and Design Core; Patient-Reported Outcomes; Health Care Systems Interactions; Regulatory/Ethics; and Stakeholder Engagement. The goal of this article is to summarize the Biostatistics and Design Core's lessons learned during the initial pilot phase with seven pragmatic clinical trials conducted between 2012 and 2014. Methodological issues arose from the five cluster-randomized trials, also called group-randomized trials, including consideration of crossover and stepped wedge designs. We outlined general themes and challenges and proposed solutions from the pilot phase including topics such as study design, unit of randomization, sample size, and statistical analysis. Our findings are applicable to other pragmatic clinical trials conducted within health care systems. Pragmatic clinical trials using the UH2/UH3 funding mechanism provide an opportunity to ensure that all relevant design issues have been fully considered in order to reliably and efficiently evaluate new interventions and treatments. The integrity and generalizability of trial results can only be ensured if rigorous designs and appropriate analysis choices are an essential part of their research protocols. © The Author(s) 2016.

Effects of lifestyle education program for type 2 diabetes patients in clinics: study design of a cluster randomized trial.

PubMed

Adachi, Misa; Yamaoka, Kazue; Watanabe, Mariko; Nishikawa, Masako; Hida, Eisuke; Kobayashi, Itsuro; Tango, Toshiro

2010-11-30

The number of patients with type 2 diabetes is drastically increasing worldwide. It is a serious health problem in Japan as well. Lifestyle interventions can reduce progression from impaired glucose tolerance to type 2 diabetes, and glycemic control has been shown to improve postprandial plasma glucose levels. Moreover, several studies have suggested that continuous interventions (combined diet and exercise) can improve the plasma glucose level and reduce dosage of hypoglycemic agents.Although many interventional studies of lifestyle education for persons with diabetes in hospitals have been reported, only a few have been clinic-based studies employing an evidence-based lifestyle education program. This article describes the design of a cluster randomized controlled trial of the effectiveness of lifestyle education for patients with type 2 diabetes in clinics by registered dietitians. In Japan, general practitioners generally have their own medical clinics to provide medical care for outpatients in the community, including those with type 2 diabetes. With the collaboration of such general practitioners, the study patients were enrolled in the present study. Twenty general practitioners were randomly allocated to each provide patients for entry into either an intervention group (10) or a control group (10). In total, 200 participants will be included in the study. The intervention group will receive intensive education on lifestyle improvement related to type 2 diabetes by registered dietitians in clinics. Lifestyle education will be conducted several times during the study period. The control group will receive information on dietary intake and standard advice on glycemic control by registered dietitians. The primary endpoint is the change from the baseline value of HbA1c at 6 months. Data on health behavior and related issues will be gathered continuously over a 6-month period. This is the first study to evaluate lifestyle education in clinics by a cluster randomization trial in Japan. The proposed study will provide practical information about the usefulness of the intensive lifestyle improvement education program in primary care settings. The study was started in September 2007 and entry of subjects was completed in December 2010. Data on the effect evaluation will be available in 2011. UMIN000004049.

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial.

PubMed

Goertz, Christine M; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Andresen, Andrew A; Jones, Mark E; Lyons, Kevin J; Hondras, Maria A; Killinger, Lisa Z; Wolinsky, Fredric D; Wallace, Robert B

2013-01-16

Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes. This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain.

A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design.

PubMed

Goswami, Neela D; Tsalik, Ephraim L; Naggie, Susanna; Miller, William C; Horton, John R; Pfeiffer, Christopher D; Hicks, Charles B

2014-01-22

The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves. We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition. The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials. No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology.

A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design

PubMed Central

2014-01-01

Background The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves. Methods We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition. Results The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials. Conclusions No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology. PMID:24450313

Counterbalancing patient demands with evidence: results from a pan-Canadian randomized clinical trial of brief supportive-expressive group psychotherapy for women with systemic lupus erythematosus.

PubMed

Dobkin, Patricia L; Da Costa, Deborah; Joseph, Lawrence; Fortin, Paul R; Edworthy, Steven; Barr, Susan; Ensworth, Stephanie; Esdaile, John M; Beaulieu, André; Zummer, Michel; Senécal, Jean-Luc; Goulet, Jean-Richard; Choquette, Denis; Rich, Eric; Smith, Doug; Cividino, Alfred; Gladman, Dafna; St-Pierre, Yvan; Clarke, Ann E

2002-01-01

To evaluate the effect of Brief Supportive-Expressive Group Psychotherapy as an adjunct to standard medical care in reducing psychological distress, medical symptoms, and health care costs and improving quality of life in women with systemic lupus erythematosus (SLE). A randomized clinical trial was conducted with 133 SLE female patients from 9 clinics across Canada. Clinical and psychosocial measures were taken at baseline, posttreatment, and 6 and 12 months posttreatment. Outcomes assessed were psychological distress, quality of life, disease activity, health service utilization, and diminished productivity. Intention-to-treat analyses revealed that there were no clinically important group differences on any of the outcome measures. Although both groups improved over time on several measures (e.g., decreases in psychological distress, stress, and emotion-oriented coping), these changes could not be attributed to the psychotherapeutic intervention. Thus, evidence does not support the referral of these patients to this type of intervention.

Multidisciplinary rehabilitation program in recently hospitalized patients with heart failure and preserved ejection fraction: rationale and design of a randomized controlled trial.

PubMed

Koifman, Edward; Grossman, Ehud; Elis, Avishay; Dicker, Dror; Koifman, Bella; Mosseri, Morris; Kuperstein, Rafael; Goldenberg, Ilan; Kamerman, Tamir; Levine-Tiefenbrun, Nava; Klempfner, Robert

2014-12-01

Heart failure with preserved ejection fraction (HFpEF) comprises a large portion of heart failure patients and portends poor prognosis with similar outcome to heart failure with reduced ejection fraction (HFrEF). Thus far, no medical therapy has been shown to improve clinical outcome in this common condition. The study is a randomized-controlled, multicenter clinical trial aimed to determine whether early posthospitalization comprehensive cardiac rehabilitation (CR) including exercise training (ET) in recently hospitalized HFpEF patients reduces the composite end point of all-cause mortality and hospitalizations in comparison with usual care (UC). After undergoing baseline evaluation, patients are randomized to either UC or to ambulatory comprehensive CR program. Patients in the CR arm will participate in a 6-month biweekly ET program according to a predefined protocol, in addition to a complementary home exercise prescribed by a specialist in CR. Exercise training will include endurance and low-intensity resistance training. Patients in the UC arm will be followed up at the outpatient clinic, with management according to current heart failure guidelines. Physician follow-up visits will be conducted at 3, 6, and 12 months for assessment of adherence to therapy and ET, functional status, quality of life, and clinical events. Secondary end points will include quality-of-life questionnaire, economic end points, blood pressure, and hemoglobin A1C levels. Cardiac rehabilitation and ET are relatively inexpensive and accessible and can be beneficial in HFpEF patients. Our trial is designed to evaluate the impact of early posthospitalization comprehensive rehabilitation program on clinical end points of mortality, hospitalization, and quality of life in HFpEF patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults

PubMed Central

Stevanovic, Goran; Lavadinovic, Lidija; Filipovic Vignjevic, Svetlana; Holt, Renée; Ilic, Katarina; Berlanda Scorza, Francesco; Sparrow, Erin; Stoiljkovic, Vera; Torelli, Guido; Madenwald, Tamra; Socquet, Muriel; Barac, Aleksandra; Ilieva-Borisova, Yordanka; Pelemis, Mijomir; Flores, Jorge

2018-01-01

ABSTRACT This study was a phase I double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity of a Serbian-produced seasonal trivalent split, inactivated influenza vaccine in healthy adults. The vaccine was manufactured in eggs by the Torlak Institute of Virology, Vaccines and Sera, Belgrade, Serbia and contained A/H1N1, A/H3N2 and B viruses. The clinical trial took place at the Clinical Center of Serbia in Belgrade. Sixty healthy volunteers, aged 18–45 years, were enrolled in the trial. On the day of immunization, volunteers were randomly assigned to receive either a single dose of the trivalent seasonal influenza vaccine (15 μg of hemagglutinin per strain) or placebo (phosphate-buffered saline). Subjects were monitored for adverse events through a clinical history and physical examination, and blood was taken for testing at screening and on day 8 to assess vaccine safety. Serum samples obtained before and 21 days after immunization were tested for influenza antibody titers using hemagglutination-inhibition (HAI) and microneutralization (MN) tests. No serious adverse events were reported. Pain and tenderness at the injection site were the most commonly reported symptoms in both vaccine and placebo groups. Overall, serum HAI responses of fourfold or greater magnitude were observed to H1, H3, and B antigen in 80%, 75%, and 70% of subjects, respectively. Seroprotection rates as measured by HAI were also high (100%, 100% and 86.67%, respectively, for H1, H3 and B). Thus, Torlak's seasonal trivalent influenza vaccine was not associated with adverse events, was well-tolerated and immunogenic. It should be further evaluated in clinical trials to provide sufficient safety and immunogenicity data for licensing in Serbia. PMID:29239682

Fractional carbon dioxide laser versus low-dose UVA-1 phototherapy for treatment of localized scleroderma: a clinical and immunohistochemical randomized controlled study.

PubMed

Shalaby, S M; Bosseila, M; Fawzy, M M; Abdel Halim, D M; Sayed, S S; Allam, R S H M

2016-11-01

Morphea is a rare fibrosing skin disorder that occurs as a result of abnormal homogenized collagen synthesis. Fractional ablative laser resurfacing has been used effectively in scar treatment via abnormal collagen degradation and induction of healthy collagen synthesis. Therefore, fractional ablative laser can provide an effective modality in treatment of morphea. The study aimed at evaluating the efficacy of fractional carbon dioxide laser as a new modality for the treatment of localized scleroderma and to compare its results with the well-established method of UVA-1 phototherapy. Seventeen patients with plaque and linear morphea were included in this parallel intra-individual comparative randomized controlled clinical trial. Each with two comparable morphea lesions that were randomly assigned to either 30 sessions of low-dose (30 J/cm 2 ) UVA-1 phototherapy (340-400 nm) or 3 sessions of fractional CO 2 laser (10,600 nm-power 25 W). The response to therapy was then evaluated clinically and histopathologically via validated scoring systems. Immunohistochemical analysis of TGF-ß1 and MMP1 was done. Patient satisfaction was also assessed. Wilcoxon signed rank test for paired (matched) samples and Spearman rank correlation equation were used as indicated. Comparing the two groups, there was an obvious improvement with fractional CO 2 laser that was superior to that of low-dose UVA-1 phototherapy. Statistically, there was a significant difference in the clinical scores (p = 0.001), collagen homogenization scores (p = 0.012), and patient satisfaction scores (p = 0.001). In conclusion, fractional carbon dioxide laser is a promising treatment modality for cases of localized morphea, with proved efficacy of this treatment on clinical and histopathological levels.

Designing and Evaluating an Interactive Multimedia Web-Based Simulation for Developing Nurses’ Competencies in Acute Nursing Care: Randomized Controlled Trial

PubMed Central

Wong, Lai Fun; Chan, Sally Wai-Chi; Ho, Jasmine Tze Yin; Mordiffi, Siti Zubaidah; Ang, Sophia Bee Leng; Goh, Poh Sun; Ang, Emily Neo Kim

2015-01-01

Background Web-based learning is becoming an increasingly important instructional tool in nursing education. Multimedia advancements offer the potential for creating authentic nursing activities for developing nursing competency in clinical practice. Objective This study aims to describe the design, development, and evaluation of an interactive multimedia Web-based simulation for developing nurses’ competencies in acute nursing care. Methods Authentic nursing activities were developed in a Web-based simulation using a variety of instructional strategies including animation video, multimedia instructional material, virtual patients, and online quizzes. A randomized controlled study was conducted on 67 registered nurses who were recruited from the general ward units of an acute care tertiary hospital. Following a baseline evaluation of all participants’ clinical performance in a simulated clinical setting, the experimental group received 3 hours of Web-based simulation and completed a survey to evaluate their perceptions of the program. All participants were re-tested for their clinical performances using a validated tool. Results The clinical performance posttest scores of the experimental group improved significantly (P<.001) from the pretest scores after the Web-based simulation. In addition, compared to the control group, the experimental group had significantly higher clinical performance posttest scores (P<.001) after controlling the pretest scores. The participants from the experimental group were satisfied with their learning experience and gave positive ratings for the quality of the Web-based simulation. Themes emerging from the comments about the most valuable aspects of the Web-based simulation include relevance to practice, instructional strategies, and fostering problem solving. Conclusions Engaging in authentic nursing activities using interactive multimedia Web-based simulation can enhance nurses’ competencies in acute care. Web-based simulations provide a promising educational tool in institutions where large groups of nurses need to be trained in acute nursing care and accessibility to repetitive training is essential for achieving long-term retention of clinical competency. PMID:25583029

Designing and evaluating an interactive multimedia Web-based simulation for developing nurses' competencies in acute nursing care: randomized controlled trial.

PubMed

Liaw, Sok Ying; Wong, Lai Fun; Chan, Sally Wai-Chi; Ho, Jasmine Tze Yin; Mordiffi, Siti Zubaidah; Ang, Sophia Bee Leng; Goh, Poh Sun; Ang, Emily Neo Kim

2015-01-12

Web-based learning is becoming an increasingly important instructional tool in nursing education. Multimedia advancements offer the potential for creating authentic nursing activities for developing nursing competency in clinical practice. This study aims to describe the design, development, and evaluation of an interactive multimedia Web-based simulation for developing nurses' competencies in acute nursing care. Authentic nursing activities were developed in a Web-based simulation using a variety of instructional strategies including animation video, multimedia instructional material, virtual patients, and online quizzes. A randomized controlled study was conducted on 67 registered nurses who were recruited from the general ward units of an acute care tertiary hospital. Following a baseline evaluation of all participants' clinical performance in a simulated clinical setting, the experimental group received 3 hours of Web-based simulation and completed a survey to evaluate their perceptions of the program. All participants were re-tested for their clinical performances using a validated tool. The clinical performance posttest scores of the experimental group improved significantly (P<.001) from the pretest scores after the Web-based simulation. In addition, compared to the control group, the experimental group had significantly higher clinical performance posttest scores (P<.001) after controlling the pretest scores. The participants from the experimental group were satisfied with their learning experience and gave positive ratings for the quality of the Web-based simulation. Themes emerging from the comments about the most valuable aspects of the Web-based simulation include relevance to practice, instructional strategies, and fostering problem solving. Engaging in authentic nursing activities using interactive multimedia Web-based simulation can enhance nurses' competencies in acute care. Web-based simulations provide a promising educational tool in institutions where large groups of nurses need to be trained in acute nursing care and accessibility to repetitive training is essential for achieving long-term retention of clinical competency.

Rational and design of a stepped-wedge cluster randomized trial evaluating quality improvement initiative for reducing cardiovascular events among patients with acute coronary syndromes in resource-constrained hospitals in China.

PubMed

Li, Shenshen; Wu, Yangfeng; Du, Xin; Li, Xian; Patel, Anushka; Peterson, Eric D; Turnbull, Fiona; Lo, Serigne; Billot, Laurent; Laba, Tracey; Gao, Runlin

2015-03-01

Acute coronary syndromes (ACSs) are a major cause of morbidity and mortality, yet effective ACS treatments are frequently underused in clinical practice. Randomized trials including the CPACS-2 study suggest that quality improvement initiatives can increase the use of effective treatments, but whether such programs can impact hard clinical outcomes has never been demonstrated in a well-powered randomized controlled trial. The CPACS-3 study is a stepped-wedge cluster-randomized trial conducted in 104 remote level 2 hospitals without PCI facilities in China. All hospitalized ACS patients will be recruited consecutively over a 30-month period to an anticipated total study population of more than 25,000 patients. After a 6-month baseline period, hospitals will be randomized to 1 of 4 groups, and a 6-component quality improvement intervention will be implemented sequentially in each group every 6months. These components include the following: establishment of a quality improvement team, implementation of a clinical pathway, training of physicians and nurses, hospital performance audit and feedback, online technical support, and patient education. All patients will be followed up for 6months postdischarge. The primary outcome will be the incidence of in-hospital major adverse cardiovascular events comprising all-cause mortality, myocardial infarction or reinfarction, and nonfatal stroke. The CPACS-3 study will be the first large randomized trial with sufficient power to assess the effects of a multifaceted quality of care improvement initiative on hard clinical outcomes, in patients with ACS. Copyright © 2014 Elsevier Inc. All rights reserved.

Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010.

PubMed

Califf, Robert M; Zarin, Deborah A; Kramer, Judith M; Sherman, Rachel E; Aberle, Laura H; Tasneem, Asba

2012-05-02

Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national trials portfolio. To examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database. A data set comprising 96,346 clinical studies from ClinicalTrials.gov was downloaded on September 27, 2010, and entered into a relational database to analyze aggregate data. Interventional trials were identified and analyses were focused on 3 clinical specialties-cardiovascular, mental health, and oncology-that together encompass the largest number of disability-adjusted life-years lost in the United States. Characteristics of registered clinical trials as reported data elements in the trial registry; how those characteristics have changed over time; differences in characteristics as a function of clinical specialty; and factors associated with use of randomization, blinding, and data monitoring committees (DMCs). The number of registered interventional clinical trials increased from 28,881 (October 2004-September 2007) to 40,970 (October 2007-September 2010), and the number of missing data elements has generally declined. Most interventional trials registered between 2007 and 2010 were small, with 62% enrolling 100 or fewer participants. Many clinical trials were single-center (66%; 24,788/37,520) and funded by organizations other than industry or the National Institutes of Health (NIH) (47%; 17,592/37,520). Heterogeneity in the reported methods by clinical specialty; sponsor type; and the reported use of DMCs, randomization, and blinding was evident. For example, reported use of DMCs was less common in industry-sponsored vs NIH-sponsored trials (adjusted odds ratio [OR], 0.11; 95% CI, 0.09-0.14), earlier-phase vs phase 3 trials (adjusted OR, 0.83; 95% CI, 0.76-0.91), and mental health trials vs those in the other 2 specialties. In similar comparisons, randomization and blinding were less frequently reported in earlier-phase, oncology, and device trials. Clinical trials registered in ClinicalTrials.gov are dominated by small trials and contain significant heterogeneity in methodological approaches, including reported use of randomization, blinding, and DMCs.

Effectiveness of patient feedback as an educational intervention to improve medical student consultation (PTA Feedback Study): study protocol for a randomized controlled trial.

PubMed

Lai, Michelle Mei Yee; Roberts, Noel; Martin, Jenepher

2014-09-17

Oral feedback from clinical educators is the traditional teaching method for improving clinical consultation skills in medical students. New approaches are needed to enhance this teaching model. Multisource feedback is a commonly used assessment method for learning among practising clinicians, but this assessment has not been explored rigorously in medical student education. This study seeks to evaluate if additional feedback on patient satisfaction improves medical student performance. The Patient Teaching Associate (PTA) Feedback Study is a single site randomized controlled, double-blinded trial with two parallel groups.An after-hours general practitioner clinic in Victoria, Australia, is adapted as a teaching clinic during the day. Medical students from two universities in their first clinical year participate in six simulated clinical consultations with ambulatory patient volunteers living with chronic illness. Eligible students will be randomized in equal proportions to receive patient satisfaction score feedback with the usual multisource feedback and the usual multisource feedback alone as control. Block randomization will be performed. We will assess patient satisfaction and consultation performance outcomes at baseline and after one semester and will compare any change in mean scores at the last session from that at baseline. We will model data using regression analysis to determine any differences between intervention and control groups. Full ethical approval has been obtained for the study. This trial will comply with CONSORT guidelines and we will disseminate data at conferences and in peer-reviewed journals. This is the first proposed trial to determine whether consumer feedback enhances the use of multisource feedback in medical student education, and to assess the value of multisource feedback in teaching and learning about the management of ambulatory patients living with chronic conditions. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613001055796.

Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial.

PubMed

Isacsson, Göran; Nohlert, Eva; Fransson, Anette M C; Bornefalk-Hermansson, Anna; Wiman Eriksson, Eva; Ortlieb, Eva; Trepp, Livia; Avdelius, Anna; Sturebrand, Magnus; Fodor, Clara; List, Thomas; Schumann, Mohamad; Tegelberg, Åke

2018-05-16

The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA. To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective. In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were randomly assigned to use either a bibloc or a monobloc appliance. One-night respiratory polygraphy without respiratory support was performed at baseline, and participants were re-examined with the appliance in place at short-term follow-up. The primary outcome was the change in the apnoea-hypopnea index (AHI). An independent person prepared a randomization list and sealed envelopes. Evaluating dentist and the biomedical analysts who evaluated the polygraphy were blinded to the choice of therapy. Of 302 patients, 146 were randomly assigned to use the bibloc and 156 the monobloc device; 123 and 139 patients, respectively, were analysed as per protocol. The mean changes in AHI were -13.8 (95% confidence interval -16.1 to -11.5) in the bibloc group and -12.5 (-14.8 to -10.3) in the monobloc group. The difference of -1.3 (-4.5 to 1.9) was significant within the equivalence interval (P = 0.011; the greater of the two P values) and was confirmed by the intention-to-treat analysis (P = 0.001). The adverse events were of mild character and were experienced by similar percentages of patients in both groups (39 and 40 per cent for the bibloc and monobloc group, respectively). The study shows short-term results with a median time from commencing treatment to the evaluation visit of 56 days and long-term data on efficacy and harm are needed to be fully conclusive. In a short-term perspective, both appliances were equivalent in terms of their positive effects for treating OSA and caused adverse events of similar magnitude. Registered with ClinicalTrials.gov (#NCT02148510).

Improved clinical outcome and biomarkers in adults with papulopustular rosacea treated with doxycycline modified-release capsules in a randomized trial.

PubMed

Di Nardo, Anna; Holmes, Anna D; Muto, Yumiko; Huang, Eugene Y; Preston, Norman; Winkelman, Warren J; Gallo, Richard L

2016-06-01

Patients with rosacea have increased amounts of cathelicidin and protease activity but their usefulness as disease biomarkers is unclear. We sought to evaluate the effect of doxycycline treatment on cathelicidin expression, protease activity, and clinical response in rosacea. In all, 170 adults with papulopustular rosacea were treated for 12 weeks with doxycycline 40-mg modified-release capsules or placebo in a multicenter, randomized, double-blind, placebo-controlled study. Clinical response was compared with cathelicidin and protease activity in stratum corneum samples obtained by tape strip and in skin biopsy specimens obtained from a random subset of patients. Treatment with doxycycline significantly reduced inflammatory lesions and improved investigator global assessment scores compared with placebo. Cathelicidin expression and protein levels decreased over the course of 12 weeks in patients treated with doxycycline. Low levels of protease activity and cathelicidin expression at 12 weeks correlated with treatment success. Low protease activity at baseline was a predictor of clinical response in the doxycycline treatment group. Healthy control subjects were not studied. Improved clinical outcome correlated with reduced cathelicidin and protease activity, supporting both the mechanism of doxycycline and the potential of these molecules as biomarkers for rosacea. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial.

PubMed

Thompson, Kirsten M J; Rocca, Corinne H; Kohn, Julia E; Goodman, Suzan; Stern, Lisa; Blum, Maya; Speidel, J Joseph; Darney, Philip D; Harper, Cynthia C

2016-03-01

We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011-2013). Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500: 802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR = 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Public funding and provider training substantially improve LARC access.

Effect of biomagnetic therapy versus physiotherapy for treatment of knee osteoarthritis: a randomized controlled trial.

PubMed

Gremion, Gerald; Gaillard, David; Leyvraz, Pierre-Francois; Jolles, Brigitte M

2009-11-01

To assess the effectiveness of pulsed signal therapy in the treatment of knee osteoarthritis (Kellgren II or III). A randomized, double-blind controlled clinical trial. The first 95 patients sent to the clinic with knee osteo-arthritis were selected and randomized into treatment with pulsed signal therapy or conventional physiotherapy. Assessment included recording of usual demographic data, pertinent history, baseline medication and radiographs. Clinical evaluation was made at baseline, 6 weeks and 6 months after the end of treatment by the same blinded doctor. At each follow-up time, the patient was asked to complete a visual analogue pain scale and a Lequesne score. The doctor recorded the degree of pain on motion and the ability to move the affected knee. Both treatments resulted in significant improvements in pain and physical function. A statistical difference was observed only for activities of daily living, where the physiotherapy was more efficient (p<0.03). The cost of treatment with pulsed signal therapy was significantly higher, double the treatment cost of conventional physiotherapy. Like physiotherapy, pulsed signal therapy has improved the clinical state of treated patients but with no significant statistical difference. Pulsed signal therapy is, however, more expensive.

Ultrasound enhanced thrombolysis: Clinical evidence

NASA Astrophysics Data System (ADS)

Alexandrov, Andrei V.

2005-04-01

Phase II CLOTBUST randomized clinical trial (Houston, Barcelona, Edmonton, Calgary) evaluated patients with acute ischemic stroke due to intracranial occlusion and treated with intravenous tissue plasminogen activator (TPA) within 3 h of symptom onset. Randomization: monitoring with pulsed wave 2 MHz transcranial Doppler (TCD) (Target) or placebo monitoring (Control). Safety: symptomatic bleeding to the brain (sICH). Primary end-point: complete recanalization on TCD or dramatic clinical recovery by the total NIHSS score <3, or improvement by >10 NIHSS points within 2 hours after TPA bolus. All projected 126 patients were randomized 1:1 to target (median NIHSS 16) or control (NIHSS 17). sICH: 4.8% Target, 4.8% Controls. Primary end-point was achieved by 31 (49%, Target) versus 19 (30%, Control), p<0.03. At 3 months, 22 (42% Target) and 14 (29% Control) patients achieved favorable outcomes. Continuous TCD monitoring of intracranial occlusion safely augments TPA-induced arterial recanalization, and 2 MHz diagnostic ultrasound has a positive biological activity that aids systemic thrombolytic therapy. For the first time in clinical medicine, the CLOTBUST trial provides the evidence that ultrasound enhances thrombolytic activity of a drug in humans thereby confirming intense multi-disciplinary experimental research conducted worldwide for the past 30 years.

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. Methods/design This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes. Discussion This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain. Trial registration This trial registered in ClinicalTrials.gov on 04 March 2011 with the ID number of NCT01312233. PMID:23324133

Effect of Abdominal Ultrasound on Clinical Care, Outcomes, and Resource Use Among Children With Blunt Torso Trauma: A Randomized Clinical Trial.

PubMed

Holmes, James F; Kelley, Kenneth M; Wootton-Gorges, Sandra L; Utter, Garth H; Abramson, Lisa P; Rose, John S; Tancredi, Daniel J; Kuppermann, Nathan

2017-06-13

The utility of the focused assessment with sonography for trauma (FAST) examination in children is unknown. To determine if the FAST examination during initial evaluation of injured children improves clinical care. A randomized clinical trial (April 2012-May 2015) that involved 975 hemodynamically stable children and adolescents younger than 18 years treated for blunt torso trauma at the University of California, Davis Medical Center, a level I trauma center. Patients were randomly assigned to a standard trauma evaluation with the FAST examination by the treating ED physician or a standard trauma evaluation alone. Coprimary outcomes were rate of abdominal computed tomographic (CT) scans in the ED, missed intra-abdominal injuries, ED length of stay, and hospital charges. Among the 925 patients who were randomized (mean [SD] age, 9.7 [5.3] years; 575 males [62%]), all completed the study. A total of 50 patients (5.4%, 95% CI, 4.0% to 7.1%) were diagnosed with intra-abdominal injuries, including 40 (80%; 95% CI, 66% to 90%) who had intraperitoneal fluid found on an abdominal CT scan, and 9 patients (0.97%; 95% CI, 0.44% to 1.8%) underwent laparotomy. The proportion of patients with abdominal CT scans was 241 of 460 (52.4%) in the FAST group and 254 of 465 (54.6%) in the standard care-only group (difference, -2.2%; 95% CI, -8.7% to 4.2%). One case of missed intra-abdominal injury occurred in a patient in the FAST group and none in the control group (difference, 0.2%; 95% CI, -0.6% to 1.2%). The mean ED length of stay was 6.03 hours in the FAST group and 6.07 hours in the standard care-only group (difference, -0.04 hours; 95% CI, -0.47 to 0.40 hours). Median hospital charges were $46 415 in the FAST group and $47 759 in the standard care-only group (difference, -$1180; 95% CI, -$6651 to $4291). Among hemodynamically stable children treated in an ED following blunt torso trauma, the use of FAST compared with standard care only did not improve clinical care, including use of resources; ED length of stay; missed intra-abdominal injuries; or hospital charges. These findings do not support the routine use of FAST in this setting. clinicaltrials.gov Identifier: NCT01540318.

Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting

PubMed Central

Wang, Ruibin; Prasad, Vinay; Bates, Susan E.; Fojo, Tito

2016-01-01

Background. Despite the ethical imperative to publish clinical trials when human subjects are involved, such data frequently remain unpublished. The objectives were to tabulate the rate and ascertain factors associated with eventual publication of clinical trial results reported as abstracts in the Proceedings of the American Society of Clinical Oncology (American Society of Clinical Oncology). Materials and Methods. Abstracts describing clinical trials for patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to 2011 were identified by using a comprehensive online database (http://meetinglibrary.asco.org/abstracts). Abstracts included reported results of a treatment or intervention assessed in a discrete, prospective clinical trial. Publication status at 4−6 years was determined by using a standardized search of PubMed. Primary outcomes were the rate of publication for abstracts of randomized and nonrandomized clinical trials. Secondary outcomes included factors influencing the publication of results. Results. A total of 1,075 abstracts describing 378 randomized and 697 nonrandomized clinical trials were evaluated. Across all years, 75% of randomized and 54% of nonrandomized trials were published, with an overall publication rate of 61%. Sample size was a statistically significant predictor of publication for both randomized and nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23 [1.11–1.36], p < .001; and 1.64 [1.15–2.34], p = .006, respectively). Among randomized studies, an industry coauthor or involvement of a cooperative group increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01, respectively). Among nonrandomized studies, phase II trials were more likely to be published than phase I (p < .001). Use of an experimental agent was not a predictor of publication in randomized (OR 0.76 [0.38–1.52]; p = .441) or nonrandomized trials (OR 0.89 [0.61–1.29]; p = .532). Conclusion. This is the largest reported study examining why oncology trials are not published. The data show that 4−6 years after appearing as abstracts, 39% of oncology clinical trials remain unpublished. Larger sample size and advanced trial phase were associated with eventual publication; among randomized trials, an industry-affiliated author or a cooperative group increased likelihood of publication. Unfortunately, we found that, despite widespread recognition of the problem and the creation of central data repositories, timely publishing of oncology clinical trials results remains unsatisfactory. Implications for Practice: The Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects notes the ethical obligation to report clinical trial data, whether positive or negative. This obligation is listed alongside requirements for risk minimization, access, confidentiality, and informed consent, all bedrocks of the clinical trial system, yet clinical trials are often not published, particularly if negative or difficult to complete. This study found that among American Society for Clinical Oncology (ASCO) Annual Meeting abstracts, 2009–2011, only 61% were published 4–6 years later: 75% of randomized trials and 54% of nonrandomized trials. Clinicians need to insist that every study in which they participate is published. PMID:26888691

Evaluating a health care provider delivered intervention to reduce intimate partner violence and mitigate associated health risks: study protocol for a randomized controlled trial in Mexico City.

PubMed

Falb, Kathryn L; Diaz-Olavarrieta, Claudia; Campos, Paola A; Valades, Jimena; Cardenas, Roosebelinda; Carino, Giselle; Gupta, Jhumka

2014-07-30

Intimate partner violence (IPV) victimization is a prevalent issue among women residing in Mexico City. Comprehensive and integrated health care provider (HCP) delivered programs in clinic-settings are needed, yet few have been evaluated in Latin America, including Mexico. In addition, there has been minimal attention to interventions among lower income women presenting at settings outside of antenatal care clinics. The current randomized controlled trial seeks to increase midlevel HCPs' capacity, specifically nurses, who are often the first point of contact in this setting, to identify women presenting at health clinics with experiences of IPV and to assist these women with health risk mitigation. Specific outcomes include changes in past-year IPV (physical and/or sexual), reproductive coercion, safety planning, use of community resources, and quality of life. Forty-two public health clinics in Mexico City were randomized to treatment or control clinics. Nurses meeting eligibility criteria in treatment groups received an intensive training on screening for IPV, providing supportive referrals, and assessing for health and safety risks. Nurses meeting eligibility criteria at control clinics received the standard of care which included a one-day training focused on sensitizing staff to IPV as a health issue and referral cards to give to women. Women were screened for eligibility (currently experiencing abuse in a heterosexual relationship, 18-44 years of age, non-pregnant or in first trimester) by research assistants in private areas of waiting rooms in health clinics. Consenting women completed a baseline survey and received the study protocol for that clinic. In treatment clinics, women received the nurse delivered session at baseline and received a follow-up counseling session after three months. Surveys are conducted at baseline, three months, and fifteen months from baseline. This study will provide important insight into whether a nurse-delivered program can assist women currently experiencing abuse in a Latin American context. Findings can be used to inform IPV programs and policies in Mexico City's public health clinics. NCT01661504.

Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV in South Africa: study protocol for a randomized controlled trial.

PubMed

Zunza, Moleen; Cotton, Mark F; Mbuagbaw, Lawrence; Lester, Richard; Thabane, Lehana

2017-07-17

South Africa recently phased out access to free formula milk in the public sector in support of breastfeeding for women living with HIV. Few women living with HIV in South Africa choose breastfeeding and among those who do, many stop breastfeeding early. We sought to explore the feasibility of using mobile phone text messaging coupled with motivational interviewing to enhance adherence to breastfeeding practices. A randomized, parallel group, single-center pilot trial. Electronic sequence generation and random allocation will be done centrally. Women of low socioeconomic status, from Cape Town, South Africa will be randomly assigned within 24 h of giving birth at a primary healthcare clinic to a structured weekly text message plus motivational interviewing and usual standard of care, using a permutation of different block sizes. Criteria for feasibility success will include: five participants recruited per week (over 12 weeks), about 75% of all eligible participants consent for study participation, complete evaluation of outcomes in at least 70% of all recruited participants, breastfeeding adherence rates of at least 70% in the intervention group, six months after delivery. Participants will be evaluated soon after giving birth and post-delivery at weeks 2, 6, 10, and 24. Primary analysis will follow the "intention-to-treat" principle. Sub-group analysis will be used to assess sub-group effects. This pilot trial will evaluate the feasibility of conducting a larger trial on communication and support approaches to improve adherence to breastfeeding by HIV-infected women. Text messaging and motivational interviewing are simple interventions which may allow participants to access personalized adherence advice and support. ClinicalTrials.gov: NCT02949713 . Registered on 26 October 2016; Pan African Clinical Trial Registry PACTR201611001855404 . Registered on 8 November 2016.

Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.

PubMed

Bowers, Alex R; Keeney, Karen; Peli, Eli

2014-02-01

There is a major lack of randomized controlled clinical trials evaluating the efficacy of prismatic treatments for hemianopia. Evidence for their effectiveness is mostly based on anecdotal case reports and open-label evaluations without a control condition. To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia. Double-masked, randomized crossover trial at 13 study sites, including the Peli laboratory at Schepens Eye Research Institute, 11 vision rehabilitation clinics in the United States, and 1 in the United Kingdom. Patients were 18 years or older with complete homonymous hemianopia for at least 3 months and without visual neglect or significant cognitive decline. Patients were allocated by minimization into 2 groups. One group received real (57-prism diopter) oblique and sham (<5-prism diopter) horizontal prisms; the other received real horizontal and sham oblique, in counterbalanced order. Each crossover period was 4 weeks. The primary outcome was the overall difference, across the 2 periods of the crossover, between the proportion of participants who wanted to continue with (said yes to) real prisms and the proportion who said yes to sham prisms. The secondary outcome was the difference in perceived mobility improvement between real and sham prisms. Of 73 patients randomized, 61 completed the crossover. A significantly higher proportion said yes to real than sham prisms (64% vs 36%; odds ratio, 5.3; 95% CI, 1.8-21.0). Participants who continued wear after 6 months reported greater improvement in mobility with real than sham prisms at crossover end (P = .002); participants who discontinued wear reported no difference. Real peripheral prism glasses were more helpful for obstacle avoidance when walking than sham glasses, with no differences between the horizontal and oblique designs. Peripheral prism glasses provide a simple and inexpensive mobility rehabilitation intervention for hemianopia. clinicaltrials.gov Identifier: NCT00494676.

Impact of aspirin resistance on outcomes among patients following coronary artery bypass grafting: exploratory analysis from randomized controlled trial (NCT01159639).

PubMed

Petricevic, Mate; Kopjar, Tomislav; Gasparovic, Hrvoje; Milicic, Davor; Svetina, Lucija; Zdilar, Boris; Boban, Marko; Mihaljevic, Martina Zrno; Biocina, Bojan

2015-05-01

Individual variability in the response to aspirin, has been established by various platelet function assays, however, the clinical relevance of aspirin resistance (AR) in patients undergoing coronary artery bypass grafting (CABG) has to be evaluated. Our working group conducted a randomized controlled trial (NCT01159639) with the aim to assess impact of dual antiplatelet therapy (APT) on outcomes among patients with AR following CABG. Patients that were aspirin resistant on fourth postoperative day (POD 4) were randomly assigned to receive either dual APT with clopidogrel (75 mg) plus aspirin (300 mg)-intervention arm or monotherapy with aspirin (300 mg)-control arm. This exploratory analysis compares clinical outcomes between aspirin resistant patients allocated to control arm and patients that have had adequate platelet inhibitory response to aspirin at POD 4. Both groups were treated with 300 mg of aspirin per day following surgery. We sought to evaluate the impact of early postoperative AR on outcomes among patients following CABG. Exploratory analysis included a total number of 325 patients. Of those, 215 patients with adequate response to aspirin and 110 patients with AR allocated to aspirin monotherapy following randomization protocol. The primary efficacy end point (MACCEs-major adverse cardiac and cardiovascular events) occurred in 10 and 6 % of patients with AR and with adequate aspirin response, respectively (p = 0.27). Non-significant differences were observed in bleeding events occurrence. Subgroup analysis of the primary end point revealed that aspirin resistant patients with BMI > 30 kg/m(2) tend to have a higher occurrence of MACCEs 18 versus 5 % (relative risk 0.44 [95 % CI 0.16-1.16]; p = 0.05). This exploratory analysis did not reveal significant impact of aspirin resistance on outcomes among patients undergoing CABG. Further, sufficiently powered studies are needed in order to evaluate clinical relevance of AR in patients undergoing CABG.

Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study.

PubMed

Jarratt, Michael; Jones, Terry; Adelglass, Jeffrey; Bucko, Alicia; Pollak, Richard; Roman-Miranda, Amaury; Olin, Jason T; Swinyer, Leonard

2014-07-01

Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis. This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis. A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (i.e., days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments. Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P< 0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle. This study was conducted in a relatively small population under controlled clinical trial conditions. Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.

Evaluation of safety and efficacy of 980-nm diode laser-assisted lipolysis versus traditional liposuction for submental rejuvenation: A randomized clinical trial.

PubMed

Valizadeh, Neda; Jalaly, Niloofar Y; Zarghampour, Manijeh; Barikbin, Behrooz; Haghighatkhah, Hamid Reza

2016-01-01

Submental fat accumulation and skin laxity is a frequent concern of cosmetic patients. The aim of this randomized prospective controlled clinical trial was to compare the efficacy and safety of laser-assisted lipolysis and liposuction in the submental rejuvenation. Thirty-six female adults were enrolled in this clinical trial and were categorized into two groups: group 1 underwent 980-nm diode laser with the power of 6-8 W and group 2 underwent traditional liposuction. Patients were evaluated with ultrasonography 2 weeks and 2 months after the procedures. Ultrasonographic evaluation reported the significant reduction of fat thickness in each group compared with the baseline (p value < 0.001). At the 2 weeks and 2 months follow-up visit, fat thickness reduction was significantly higher in the lipolysis group (p value < 0.05). Overall patients' satisfaction in lipolysis group was higher than liposuction with 11 (61%) of lipolysis patients being very satisfied in contrast to 10 (55.5%) of liposuction patients reporting "dissatisfied or neutral" results. Laser-assisted lipolysis using 980-nm diode is approved to be safe and effective for skin tightening and rejuvenation of the submental area and seems to be a better option than traditional techniques for treatment of this cosmetic problem.

Developing evidence-based dentistry skills: how to interpret randomized clinical trials and systematic reviews.

PubMed

Kiriakou, Juliana; Pandis, Nikolaos; Madianos, Phoebus; Polychronopoulou, Argy

2014-10-30

Decision-making based on reliable evidence is more likely to lead to effective and efficient treatments. Evidence-based dentistry was developed, similarly to evidence-based medicine, to help clinicians apply current and valid research findings into their own clinical practice. Interpreting and appraising the literature is fundamental and involves the development of evidence-based dentistry (EBD) skills. Systematic reviews (SRs) of randomized controlled trials (RCTs) are considered to be evidence of the highest level in evaluating the effectiveness of interventions. Furthermore, the assessment of the report of a RCT, as well as a SR, can lead to an estimation of how the study was designed and conducted.

Randomized trial for answers to clinical questions: evaluating a pre-appraised versus a MEDLINE search protocol.

PubMed

Patel, Manesh R; Schardt, Connie M; Sanders, Linda L; Keitz, Sheri A

2006-10-01

The paper compares the speed, validity, and applicability of two different protocols for searching the primary medical literature. A randomized trial involving medicine residents was performed. An inpatient general medicine rotation was used. Thirty-two internal medicine residents were block randomized into four groups of eight. Success rate of each search protocol was measured by perceived search time, number of questions answered, and proportion of articles that were applicable and valid. Residents randomized to the MEDLINE-first (protocol A) group searched 120 questions, and residents randomized to the MEDLINE-last (protocol B) searched 133 questions. In protocol A, 104 answers (86.7%) and, in protocol B, 117 answers (88%) were found to clinical questions. In protocol A, residents reported that 26 (25.2%) of the answers were obtained quickly or rated as "fast" (<5 minutes) as opposed to 55 (51.9%) in protocol B, (P = 0.0004). A subset of questions and articles (n = 79) were reviewed by faculty who found that both protocols identified similar numbers of answer articles that addressed the questions and were felt to be valid using critical appraisal criteria. For resident-generated clinical questions, both protocols produced a similarly high percentage of applicable and valid articles. The MEDLINE-last search protocol was perceived to be faster. However, in the MEDLINE-last protocol, a significant portion of questions (23%) still required searching MEDLINE to find an answer.

The efficacy of electroacupuncture for the treatment of simple female stress urinary incontinence - comparison with pelvic floor muscle training: study protocol for a multicenter randomized controlled trial.

PubMed

Su, Tongsheng; Zhou, Jing; Liu, Zhishun; Chen, Yuelai; Zhang, Wei; Chu, Haoran; Luo, Qiong; Lu, Jin; An, Junming; Liu, Baoyan

2015-02-08

Previous research has shown that electroacupuncture therapy has a potential therapeutic effect for simple female stress urinary incontinence. In this study, pelvic floor muscle training, the first-line treatment for stress urinary incontinence in women based on meta-analysis of numerous randomized control trials and recommended by international clinical practice, is used as a control group to demonstrate whether electroacupuncture therapy is a better method for female stress urinary incontinence. A randomized controlled trial has been designed to evaluate the therapeutic benefit of electroacupuncture for female stress urinary incontinence compared with pelvic floor muscle training. The safety of electroacupuncture and patient compliance will also be evaluated. Untoward reaction to the electroacupuncture, including a broken needle, fainting on acupuncture, or pain during acupuncture, will be recorded and the therapy will be stopped if an untoward reaction occurs. After we have received full ethical approval and patient consent, participants will be randomized to receive a series of 24 electroacupuncture or pelvic floor muscle training interventions. The frequency and amount of leakage will be measured as the primary outcome parameters. Secondary outcome parameters include the 1-hour pad test, the short-form of the International Consultation on Incontinence Questionnaire, patient subjective effectiveness evaluation, weekly usage of pad, and usage of specialty therapy for female stress urinary incontinence. This trial will help to determine whether electroacupuncture is a more effective treatment than pelvic floor muscle training for patients with female stress urinary incontinence. ClinicalTrials.gov NCT01940432 (12 September 2013).

Thrombelastographic haemostatic status and antiplatelet therapy after coronary artery bypass surgery (TEG-CABG trial): assessing and monitoring the antithrombotic effect of clopidogrel and aspirin versus aspirin alone in hypercoagulable patients: study protocol for a randomized controlled trial.

PubMed

Rafiq, Sulman; Johansson, Pär Ingemar; Zacho, Mette; Stissing, Trine; Kofoed, Klaus; Lilleør, Nikolaj Bang; Steinbrüchel, Daniel Andreas

2012-04-27

Hypercoagulability, assessed by the thrombelastography (TEG) assay, has in several observational studies been associated with an increased risk of post-procedural thromboembolic complications. We hypothesize that intensified antiplatelet therapy with clopidogrel and aspirin, as compared to aspirin alone, will improve saphenous vein graft patency in preoperatively TEG-Hypercoagulable coronary artery bypass surgery (CABG) patients and reduce their risk for thromboembolic complications and death postoperatively. This is a prospective randomized clinical trial, with an open-label design with blinded evaluation of graft patency. TEG-Hypercoagulability is defined as a TEG maximum amplitude above 69 mm. Two hundred and fifty TEG-Hypercoagulable patients will be randomized to either an interventional group receiving clopidogrel 75 mg daily for three months (after initial oral bolus of 300 mg) together with aspirin 75 mg or a control group receiving aspirin 75 mg daily alone. Monitoring of antiplatelet efficacy and on-treatment platelet reactivity to clopidogrel and aspirin will be conducted with Multiplate aggregometry. Graft patency will be assessed with Multislice computed tomography (MSCT) at three months after surgery. The present trial is the first randomized clinical trial to evaluate whether TEG-Hypercoagulable CABG patients will benefit from intensified antiplatelet therapy after surgery. Monitoring of platelet inhibition from instituted antithrombotic therapy will elucidate platelet resistance patterns after CABG surgery. The results could be helpful in redefining how clinicians can evaluate patients preoperatively for their postoperative thromboembolic risk and tailor individualized postoperative antiplatelet therapy. Clinicaltrials.gov Identifier NCT01046942.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state)--a prospective multicenter randomized controlled clinical trial using a comprehensive cohort design.

PubMed

Moergel, Maximilian; Jahn-Eimermacher, Antje; Krummenauer, Frank; Reichert, Torsten E; Wagner, Wilfried; Wendt, Thomas G; Werner, Jochen A; Al-Nawas, Bilal

2009-12-23

Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. ClinicalTrials.gov: NCT00964977.

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. I. Main results of the studies].

PubMed

Jermendy, György

2018-04-01

The effect of antihyperglycaemic (antidiabetic) treatment on the late diabetic complications is one of the most important research areas in clinical diabetology. The relationship between glycaemic control and late micro- and macrovascular complications was highlighted by the results of the DCCT (Diabetes Control and Complications Trial) with type 1 and by the UKPDS (United Kingdom Prospective Diabetes Study) with type 2 diabetic patients. In these studies, observational follow-up investigations were also performed after the close-out of the randomized phase of the trial. In addition to these landmark studies, other randomized, controlled efficacy trials were also performed with observational follow-up investigations resulting in the development of the concept of metabolic memory or metabolic legacy. In this article, the main results of the studies are summarized. Orv Hetil. 2018; 159(15): 575-582.

Effectiveness of orthodontic treatment with functional appliances on maxillary growth in the short term: A systematic review and meta-analysis.

PubMed

Nucera, Riccardo; Lo Giudice, Antonino; Rustico, Lorenzo; Matarese, Giovanni; Papadopoulos, Moschos A; Cordasco, Giancarlo

2016-05-01

The aim of this systematic review was to evaluate the treatment effects on maxillary growth of removable functional appliances that advance the mandible to a more forward position in patients with Class II malocclusion. Sixteen electronic databases and reference lists of studies were searched up to April 2015. Only randomized clinical trials and prospective controlled clinical trials investigating Class II growing patients treated with removable functional appliances were included. Two authors independently accomplished study selection, data extraction, and risk of bias assessment. All pooled analyses of data were based on random-effects models. Statistical heterogeneity was evaluated. In total, 14 studies were included (5 randomized clinical trials, 9 prospective controlled clinical trials) that collected data from 765 patients (405 treated, 360 untreated controls). The mean differences in treatment effect of functional appliances, relative to the untreated controls, were -0.61° per year (95% CI, -0.69° to -0.25°) for SNA angle, -0.61 mm per year (95% CI, -0.90 to -0.32 mm) for anterior maxillary displacement, and +0.07° per year (95% CI, -0.17° to +0.32°) for maxillary plane rotation. Removable functional appliances in Class II growing patients have a slight inhibitory effect on the sagittal growth of the maxilla in the short term, but they do not seem to affect rotation of the maxillary plane. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Active involvement and intervention in patients exposed to whiplash trauma in automobile crashes reduces costs: a randomized, controlled clinical trial and health economic evaluation.

PubMed

Rosenfeld, Mark; Seferiadis, Aris; Gunnarsson, Ronny

2006-07-15

To examine and compare the costs and consequences in a partial economic evaluation of two competing interventions in patients exposed to whiplash trauma in automobile crashes. The interventions were an active involvement and intervention using early mobilization and a standard intervention of rest, recommended short-term immobilization in a cervical collar and a cautious, gradual self-exercise program according to a leaflet. The study was randomized and controlled. The aim of the study was to compare the costs of an active involvement and intervention versus a standard intervention and to relate them to the clinical benefits in patients exposed to whiplash trauma in automobile crashes to facilitate decision-making regarding intervention and resource allocation. There is very little known about the health economic aspects of various interventions in the target treatment group of patients. Based on a prospective, randomized, clinical trial, data on clinical effectiveness and resources used for the active involvement and intervention and standard intervention were collected for a comparative analysis of the costs related to physical therapy treatment and sick leave. A cost-consequence analysis consisting of a modified cost-effectiveness analysis was used. The costs were significantly lower after 6 and 36 months with an active involvement and intervention as compared with the standard intervention. The active involvement and intervention were significantly superior in reducing experienced pain and reducing sick leave. For patients exposed to whiplash trauma in a motor vehicle collision, an active involvement and intervention were both less costly and more effective than a standard intervention.

Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial.

PubMed

Engen, Deborah J; Carns, Paul E; Allen, Mark S; Bauer, Brent A; Loehrer, Laura L; Cha, Stephen S; Chartrand, Christine M; Eggler, Eric J; Cutshall, Susanne M; Wahner-Roedler, Dietlind L

2016-05-01

Transcutaneous electrical nerve stimulation (TENS) has been applied for pain relief after surgical procedures. This study evaluated whether TENS after video-assisted thoracoscopic surgery (VATS), in addition to opioid administration, decreased postoperative pain and pain medication use. In a controlled trial, 56 patients scheduled to undergo VATS were randomly assigned to TENS plus opioids (Group 1) or opioids alone (Group 2) for 48 h. Forty patients completed the study. Pain scores and use of oral morphine equivalents (OMEs) were not significantly different between the groups during the first and second 24 h. A decreased use of OMEs between the first and second 24 h was significant for Group 1 (P = .005) but not for Group 2 (P = .11); a decreased use of OMEs between groups was not significant (P = .35). A larger, well-powered clinical trial is indicated to evaluate the effects of TENS for pain control after a VATS procedure. Clinical Trial No.: NCT01046695. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Clinical image quality evaluation for panoramic radiography in Korean dental clinics

PubMed Central

Choi, Bo-Ram; Choi, Da-Hye; Huh, Kyung-Hoe; Yi, Won-Jin; Heo, Min-Suk; Choi, Soon-Chul; Bae, Kwang-Hak

2012-01-01

Purpose The purpose of this study was to investigate the level of clinical image quality of panoramic radiographs and to analyze the parameters that influence the overall image quality. Materials and Methods Korean dental clinics were asked to provide three randomly selected panoramic radiographs. An oral and maxillofacial radiology specialist evaluated those images using our self-developed Clinical Image Quality Evaluation Chart. Three evaluators classified the overall image quality of the panoramic radiographs and evaluated the causes of imaging errors. Results A total of 297 panoramic radiographs were collected from 99 dental hospitals and clinics. The mean of the scores according to the Clinical Image Quality Evaluation Chart was 79.9. In the classification of the overall image quality, 17 images were deemed 'optimal for obtaining diagnostic information,' 153 were 'adequate for diagnosis,' 109 were 'poor but diagnosable,' and nine were 'unrecognizable and too poor for diagnosis'. The results of the analysis of the causes of the errors in all the images are as follows: 139 errors in the positioning, 135 in the processing, 50 from the radiographic unit, and 13 due to anatomic abnormality. Conclusion Panoramic radiographs taken at local dental clinics generally have a normal or higher-level image quality. Principal factors affecting image quality were positioning of the patient and image density, sharpness, and contrast. Therefore, when images are taken, the patient position should be adjusted with great care. Also, standardizing objective criteria of image density, sharpness, and contrast is required to evaluate image quality effectively. PMID:23071969

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Rigorously Assessing Whether the Data Backs the Back School

PubMed Central

Vinh, David T.; Johnson, Craig W.; Phelps, Cynthia L.

2003-01-01

A rigorous between-subjects methodology employing independent random samples and having broad clinical applicability was designed and implemented to evaluate the effectiveness of back safety and patient transfer training interventions for both hospital nurses and nursing assistants. Effects upon self-efficacy, cognitive, and affective measures are assessed for each of three back safety procedures. The design solves the problem of obtaining randomly assigned independent controls where all experimental subjects must participate in the training interventions. PMID:14728544

Effectiveness of Azadirachta indica (neem) mouthrinse in plaque and gingivitis control: a systematic review.

PubMed

Dhingra, K; Vandana, K L

2017-02-01

The aim of this systematic review was to evaluate the effectiveness of Azadirachta indica (neem)-based herbal mouthrinse in improving plaque control and gingival health. Literature search was accomplished using electronic databases (PubMed, Cochrane Central Register of Controlled Trials and EMBASE) and manual searching, up to February 2015, for randomized controlled trials (RCTs) presenting clinical data for efficacy of neem mouthrinses when used alone or as an adjunct to mechanical oral hygiene as compared to chlorhexidine mouthrinses for controlling plaque and gingival inflammation in patients with gingivitis. Of the total 206 articles searched, three randomized controlled trials evaluating neem-based herbal mouthrinses were included. Due to marked heterogeneity observed in study characteristics, meta-analysis was not performed. These studies reported that neem mouthrinse was as effective as chlorhexidine mouthrinse when used as an adjunct to toothbrushing in reducing plaque and gingival inflammation in gingivitis patients. However, the quality of reporting and evidence along with methods of studies was generally flawed with unclear risk of bias. Despite the promising results shown in existing randomized controlled trials, the evidence concerning the clinical use of neem mouthrinses is lacking and needs further reinforcement with high-quality randomized controlled trials based on the reporting guidelines of herbal CONSORT statement. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Evaluating treatment of obstructive sleep apnea comorbid with insomnia disorder using an incomplete factorial design

PubMed Central

Crawford, Megan R.; Turner, Arlener D.; Wyatt, James K.; Fogg, Louis F.; Ong, Jason C.

2016-01-01

Chronic insomnia disorder is a prevalent condition and a significant proportion of these individuals also have obstructive sleep apnea (OSA). These two sleep disorders have distinct pathophysiology and are managed with different treatment approaches. High comorbidity rates have been a catalyst for emerging studies examining multidisciplinary treatment for OSA comorbid with insomnia disorder. In this article, we describe a randomized clinical trial of Cognitive Behavioral Treatment for insomnia (CBT-I) and Positive Airway Pressure (PAP) for OSA. Participants are randomized to receive one of three treatment combinations. Individuals randomized to treatment Arm A receive sequential treatment beginning with CBT-I followed by PAP, in treatment Arm B CBT-I and PAP are administered concurrently. These treatment arms are compared to a control condition, treatment Arm C, where individuals receive PAP alone. Adopting an incomplete factorial study design will allow us to evaluate the efficacy of multidisciplinary treatment (Arms A & B) versus standard treatment alone (Arm C). In addition, the random allocation of individuals to the two different combined treatment sequences (Arm A and Arm B) will allow us to understand the benefits of the sequential administration of CBT-I and PAP relative to concurrent treatment of PAP and CBT-I. These findings will provide evidence of the clinical benefits of treating insomnia disorder in the context of OSA. PMID:26733360

Evaluation of the effects of a diabetes educational program: a randomized clinical trial

PubMed Central

Torres, Heloísa de Carvalho; Pace, Ana Emília; Chaves, Fernanda Figueredo; Velasquez-Melendez, Gustavo; Reis, Ilka Afonso

2018-01-01

ABSTRACT OBJECTIVE Evaluate the effectiveness of a diabetes mellitus educational program in primary health care. METHODS This cluster randomized trial was conducted in a sample of 470 people with type 2 diabetes mellitus from eight health units, randomly assigned to two groups: intervention (n = 231) and control (n = 239). The intervention group participated in the educational program composed of three strategies: group education, home visit, and telephone intervention. Simultaneously, the control group was monitored individually. Group monitoring took place over nine months in the year 2012. Clinical evaluations were performed at the initial time (T0), three (T3), six (T6) and nine (T9) months after the beginning of the intervention. RESULTS After nine months of follow-up, 341 users remained in the study, 171 in the control group and 170 in the intervention group. The average age of users was 60.6 years. In both groups, statistically significant differences were observed in mean HbA1c levels over the follow-up time (p < 0.05). However, the mean HbA1c level at T3, T6 and T9 times were significantly lower among the people in the intervention group (p < 0.05). CONCLUSIONS The educational program model developed was effective to improve the glycemic control of the intervention group participants. PMID:29412378

Atomic force microscopy and scanning electron microscopy evaluation of efficacy of scaling and root planing using magnification: A randomized controlled clinical study

PubMed Central

Mohan, Ranjana; Agrawal, Sudhanshu; Gundappa, Mohan

2013-01-01

Aim: A randomized controlled clinical study was undertaken to evaluate the effectiveness of scaling and root planing (SRP) by using Magnifying Loupes (ML) and dental operating microscope (DOM). Materials and Methods: A total of 90 human teeth scheduled for extraction from 18 patients aged between 25 and 65 years suffering from generalized chronic severe periodontitis were randomly assigned to three treatment groups. Group 1 consisted SRP performed without using magnification (unaided), Group 2-SRP with ML and Group 3-SRP with DOM. Following extractions, samples were prepared for (i) evaluation of surface topography by atomic force microscopy, (ii) presence of smear layer, debris by scanning electron microscopy (iii) elemental analysis by energy dispersive X-ray analysis. Data was subjected to statistical analysis using analysis of variance, post-hoc (Tukey-HSD) and Chi-square test. Results: Statistically significant (P < 0.001) difference was found among the different treatment groups. Group 3 was the best while Group 1 was the least effective technique for SRP. Order of efficacy in terms of the surface was found to be - Palatal < Lingual < Distal ≃ Mesial < Buccal. Efficiency in mandibular to maxillary teeth was found to be significant (P < 0.05), also anterior to posterior teeth (P < 0.05). Conclusion: Magnification tools significantly enhance the efficacy of supragingival and subgingival SRP. PMID:24124292

Preemptive Use of Naproxen on Tooth Sensitivity Caused by In-Office Bleaching: A Triple-Blind, Crossover, Randomized Clinical Trial.

PubMed

Fernandes, M T; Vaez, S C; Lima, C M; Nahsan, F P; Loguércio, A D; Faria-E-Silva, A L

A triple-blind, randomized, crossover clinical trial evaluated prior use of nonsteroidal anti-inflammatory naproxen on sensitivity reported by patients undergoing in-office tooth bleaching. Fifty patients were subjected to two sessions of in-office tooth bleaching with 35% hydrogen peroxide in a single application of 40 minutes for two sessions, with an interval of seven days between applications. One hour prior to the procedure, each patient randomly received a single dose of naproxen (500 mg) or placebo. The patient's sensitivity level was evaluated during and immediately after the bleaching using two scales (verbal and visual analog); the verbal scale only was repeated after 24 hours. The effectiveness of the bleaching procedures was evaluated with the Bleachedguide scale. Relative risk to sensitivity was calculated and adjusted by session, while comparison of overall risk was performed by the McNemar test. Data on the sensitivity level for both scales and shade were subjected to the Friedman, Wilcoxon, and Mann-Whitney tests (α=0.05). The use of naproxen only decreased the absolute risk and intensity of tooth sensitivity reported immediately after the second session. On the other hand, no measurable effect was observed during or 24 hours after either session. The sequence of drug administration did not affect the bleaching effectiveness. Preemptive use of naproxen only reduced tooth sensitivity reported by patients immediately after the second session of bleaching.

Evaluation and implementation of highly challenging balance training in clinical practice for people with Parkinson's disease: protocol for the HiBalance effectiveness-implementation trial.

PubMed

Leavy, Breiffni; Kwak, Lydia; Hagströmer, Maria; Franzén, Erika

2017-02-07

If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented. The HiBalance program is systemically designed to target balance impairments in PD and has been shown effective at improving balance control and gait in a previous RCT. Study aims are to i) determine the effectiveness of the adapted HiBalance program on performance and self-rated outcomes such as balance control, gait and physical activity level ii) conduct a process evaluation of program implementation at the various clinics iii) determine barriers and facilitators to program implementation in these settings. This effectiveness-implementation type 1 hybrid study will use a non-randomized controlled design with consecutive inclusion of people with PD at multiple clinical sites. A mixed method approach will be used to collect clinical effectiveness data and process evaluation data which is both quantitative and qualitative in nature. The consolidated framework for implementation research (CFIR) will be used to guide the planning and collection of data concerning implementation barriers and facilitators. The HiBalance program will be provided by physical therapists as a part of standard rehabilitation care at the clinical sites, while the evaluation of the implementation process will be performed by the research group and funded by research grants. An effectiveness-implementation study design benefits patients by speeding up the process of translating findings from research settings to routine health care. Findings from this study will also be highly relevant for those working with neurological rehabilitation when faced with decisions concerning the translation of training programs from efficacy studies to everyday clinical practice. ClinicalTrials.gov march 2016, NCT02727478 .

EFFICACY OF TACROLIMUS FOR INDUCTION OF REMISSION IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS: A SYSTEMATIC REVIEW AND META-ANALYSIS.

PubMed

Lasa, Juan; Olivera, Pablo

2017-01-01

There is evidence that shows that calcineurin inhibitors may be useful for the treatment of severe ulcerative colitis. However, evidence regarding the efficacy of tacrolimus for remission induction in this setting is scarce. To develop a systematic review on the existing evidence regarding the clinical efficacy of tacrolimus for the induction of remission in patients with moderate-to-severe ulcerative colitis. A literature search was undertaken from 1966 to August 2016 using MEDLINE, Embase, LILACS and the Cochrane Library. The following MeSH terms were used: "Inflammatory Bowel Diseases" or "Ulcerative Colitis" and "Calcineurin Inhibitors" or "Tacrolimus" or "FK506". Studies performed in adult ulcerative colitis patients that evaluated the clinical efficacy of tacrolimus for the induction of remission were considered for revision. A meta-analysis was performed with those included studies that were also placebo-controlled and randomized. Clinical response as well as clinical remission and mucosal healing were evaluated. Overall, 755 references were identified, from which 22 studies were finally included. Only two of them were randomized, placebo-controlled trials. A total of 172 patients were evaluated. A significantly lower risk of failure in clinical response was found for tacrolimus versus placebo [RR 0.58 (0.45-0.73)]; moreover, a lower risk of failure in the induction of remission was also found versus placebo [RR 0.91 (0.82-1)]. Tacrolimus seems to be a valid therapeutic alternative for the induction of remission in patients with moderate-to-severe ulcerative colitis.

Has platelet-rich plasma any role in anterior cruciate ligament allograft healing?

PubMed

Nin, Juan Ramón Valentí; Gasque, Gonzalo Mora; Azcárate, Andrés Valentí; Beola, Jesús Dámaso Aquerreta; Gonzalez, Milagros Hernandez

2009-11-01

The aim of this study was to evaluate and compare the clinical and inflammatory parameters with the addition of platelet-derived growth factor (PDGF) in primary anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone allograft. We prospectively randomized 100 patients undergoing arthroscopic patellar tendon allograft ACL reconstruction to a group in whom platelet-enriched gel was used (n = 50) and a non-gel group (n = 50). The platelet concentration was 837 x 10(3)/mm(3), and the gel was introduced inside the graft and the tibial tunnel. Demographic data were comparable between groups. The mean follow-up was 24 months for both groups and included a history, clinical evaluation with the International Knee Documentation Committee score, radiographs, and magnetic resonance imaging. There were no differences in the number of associated injuries. The results did not show any statistically significant differences between the groups for inflammatory parameters (perimeters of the knee and C-reactive protein level), magnetic resonance imaging appearance of the graft, and clinical evaluation scores (visual analog scale, International Knee Documentation Committee, and KT-1000 arthrometer [MEDmetric, San Diego, CA]). At this time, the therapeutic role of PDGF in ACL reconstruction remains unclear. The use of PDGF, on the graft and inside the tibial tunnel, in patients treated with bone-patellar tendon-bone allografts has no discernable clinical or biomechanical effect at 2 years' follow-up. More clinical studies will be needed to show the efficacy and use of these factors in daily practice in ACL reconstruction. Level I, prospective, randomized, double-blind study.

'Treat to Target' - Lessons Learnt.

PubMed

Kurti, Zsuzsanna; Vegh, Zsuzsanna; Golovics, Petra Anna; Lakatos, Peter Laszlo

2016-01-01

Therapeutic management in inflammatory bowel diseases (IBD) has significantly changed in the last decades with the advent of biological therapy resulting in new treatment targets other than clinical symptoms. Patient stratification in the early stage of the disease is an important step to identify patients with poor prognosis, who might benefit from early aggressive treatment to avoid complications in the later disease course. Recent randomized and hypothesis driven (e.g., Randomized Evaluation of an Algorithm for Crohn's Treatment, Post-Operative Crohn's Endoscopic Recurrence) clinical trials conducted in the biological era underscore the need of objective disease monitoring including assessment of biomarkers (e.g., C-reactive protein and calprotectin), mucosal healing and, for biologically treated patients, therapeutic drug monitoring beside clinical symptom assessment in both Crohn's disease and ulcerative colitis. Assessing the treatment efficacy objectively has become an important element of patient monitoring besides clinical symptom assessment. Further clinical studies are needed to assess whether implementation of new therapeutic algorithms based on these targets and tight monitoring in clinical practice have the potential to further improve long-term disease outcomes in IBD. © 2016 S. Karger AG, Basel.

Effectiveness of computerized clinical decision support systems for asthma and chronic obstructive pulmonary disease in primary care: a systematic review.

PubMed

Fathima, Mariam; Peiris, David; Naik-Panvelkar, Pradnya; Saini, Bandana; Armour, Carol Lyn

2014-12-02

The use of computerized clinical decision support systems may improve the diagnosis and ongoing management of chronic diseases, which requires recurrent visits to multiple health professionals, disease and medication monitoring and modification of patient behavior. The aim of this review was to systematically review randomized controlled trials evaluating the effectiveness of computerized clinical decision systems (CCDSS) in the care of people with asthma and COPD. Randomized controlled trials published between 2003 and 2013 were searched using multiple electronic databases Medline, EMBASE, CINAHL, IPA, Informit, PsychINFO, Compendex, and Cochrane Clinical Controlled Trials Register databases. To be included, RCTs had to evaluate the role of the CCDSSs for asthma and/or COPD in primary care. Nineteen studies representing 16 RCTs met our inclusion criteria. The majority of the trials were conducted in patients with asthma. Study quality was generally high. Meta-analysis was not conducted because of methodological and clinical heterogeneity. The use of CCDSS improved asthma and COPD care in 14 of the 19 studies reviewed (74%). Nine of the nineteen studies showed statistically significant (p < 0.05) improvement in the primary outcomes measured. The majority of the studies evaluated health care process measures as their primary outcomes (10/19). Evidence supports the effectiveness of CCDSS in the care of people with asthma. However there is very little information of its use in COPD care. Although there is considerable improvement in the health care process measures and clinical outcomes through the use of CCDSSs, its effects on user workload and efficiency, safety, costs of care, provider and patient satisfaction remain understudied.

Ruxolitinib reduces JAK2 p.V617F allele burden in patients with polycythemia vera enrolled in the RESPONSE study.

PubMed

Vannucchi, Alessandro Maria; Verstovsek, Srdan; Guglielmelli, Paola; Griesshammer, Martin; Burn, Timothy C; Naim, Ahmad; Paranagama, Dilan; Marker, Mahtab; Gadbaw, Brian; Kiladjian, Jean-Jacques

2017-07-01

In patients with polycythemia vera (PV), an elevated JAK2 p.V617F allele burden is associated with indicators of more severe disease (e.g., leukocytosis, splenomegaly, and increased thrombosis risk); however, correlations between allele burden reductions and clinical benefit in patients with PV have not been extensively evaluated in a randomized trial. This exploratory analysis from the multicenter, open-label, phase 3 Randomized Study of Efficacy and Safety in Polycythemia Vera With JAK Inhibitor INCB018424 Versus Best Supportive Care trial evaluated the long-term effect of ruxolitinib treatment on JAK2 p.V617F allele burden in patients with PV. Evaluable JAK2 p.V617F-positive patients randomized to ruxolitinib (n = 107) or best available therapy (BAT) who crossed over to ruxolitinib at week 32 (n = 97) had consistent JAK2 p.V617F allele burden reductions throughout the study. At all time points measured (up to weeks 208 [ruxolitinib-randomized] and 176 [ruxolitinib crossover]), mean changes from baseline over time in JAK2 p.V617F allele burden ranged from -12.2 to -40.0% (ruxolitinib-randomized) and -6.3 to -17.8% (ruxolitinib crossover). Complete or partial molecular response was observed in 3 patients (ruxolitinib-randomized, n = 2; ruxolitinib crossover, n = 1) and 54 patients (ruxolitinib-randomized, n = 33; ruxolitinib crossover, n = 20; BAT, n = 1), respectively. Among patients treated with interferon as BAT (n = 13), the mean maximal reduction in allele burden from baseline was 25.6% after crossover to ruxolitinib versus 6.6% before crossover. Collectively, the data from this exploratory analysis suggest that ruxolitinib treatment for up to 4 years provides progressive reductions in JAK2 p.V617F allele burden in patients with PV who are resistant to or intolerant of hydroxyurea. The relationship between allele burden changes and clinical outcomes in patients with PV remains unclear.

Safety and Efficacy of Rice Bran Supercritical CO2 Extract for Hair Growth in Androgenic Alopecia: A 16-Week Double-Blind Randomized Controlled Trial.

PubMed

Choi, Jae-Suk; Park, Jae Beom; Moon, Woi-Sook; Moon, Jin-Nam; Son, Sang Wook; Kim, Mi-Ryung

2015-01-01

We conducted a 16-week double-blind randomized controlled single-center trial to evaluate the safety and efficacy of dermal rice bran supercritical CO2 extract (RB-SCE) in the treatment of androgenic alopecia. Fifty alopecia patients were randomly assigned to the experimental and placebo groups. The experimental group received a dermal application of 0.5% RB-SCE (8 mL/d) to the head skin for 16 weeks while the control group received a dermal application of placebo. Changes in hair count, diameter, and density were evaluated with a Folliscope(®). Patient satisfaction was evaluated via questionnaire and clinical photographs were rated by dermatologists. The results showed that RB-SCE significantly increased hair density and hair diameter in male subjects. Patient satisfaction and the evaluation of photographs by dermatologists also confirmed the effectiveness of RB-SCE in the treatment of alopecia. No adverse reactions related to RB-SCE were reported. Therefore, RB-SCE shows promise for use in functional cosmetics and pharmaceuticals.

Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2011-12-01

Randomization is a key step in reducing selection bias during the treatment allocation phase in randomized clinical trials. The process of randomization follows specific steps, which include generation of the randomization list, allocation concealment, and implementation of randomization. The phenomenon in the dental and orthodontic literature of characterizing treatment allocation as random is frequent; however, often the randomization procedures followed are not appropriate. Randomization methods assign, at random, treatment to the trial arms without foreknowledge of allocation by either the participants or the investigators thus reducing selection bias. Randomization entails generation of random allocation, allocation concealment, and the actual methodology of implementing treatment allocation randomly and unpredictably. Most popular randomization methods include some form of restricted and/or stratified randomization. This article introduces the reasons, which make randomization an integral part of solid clinical trial methodology, and presents the main randomization schemes applicable to clinical trials in orthodontics.

Role of multidetector computed tomography in the diagnosis and management of patients attending the rapid access chest pain clinic, The Scottish computed tomography of the heart (SCOT-HEART) trial: study protocol for randomized controlled trial

PubMed Central

2012-01-01

Background Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of noninvasive computed tomography, which can be used to measure coronary artery calcium scores and perform coronary angiography in one examination. However, this technology has not been robustly evaluated in its application to the clinic. Methods/design The SCOT-HEART study is an open parallel group prospective multicentre randomized controlled trial of 4,138 patients attending the rapid access chest pain clinic for evaluation of suspected cardiac chest pain. Following clinical consultation, participants will be approached and randomized 1:1 to receive standard care or standard care plus ≥64-multidetector computed tomography coronary angiography and coronary calcium score. Randomization will be conducted using a web-based system to ensure allocation concealment and will incorporate minimization. The primary endpoint of the study will be the proportion of patients diagnosed with angina pectoris secondary to coronary heart disease at 6 weeks. Secondary endpoints will include the assessment of subsequent symptoms, diagnosis, investigation and treatment. In addition, long-term health outcomes, safety endpoints, such as radiation dose, and health economic endpoints will be assessed. Assuming a clinic rate of 27.0% for the diagnosis of angina pectoris due to coronary heart disease, we will need to recruit 2,069 patients per group to detect an absolute increase of 4.0% in the rate of diagnosis at 80% power and a two-sided P value of 0.05. The SCOT-HEART study is currently recruiting participants and expects to report in 2014. Discussion This is the first study to look at the implementation of computed tomography in the patient care pathway that is outcome focused. This study will have major implications for the management of patients with cardiovascular disease. Trial registration ClinicalTrials.gov Identifier: NCT01149590 PMID:23036114

Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial.

PubMed

Chen, Fa-Ming; Gao, Li-Na; Tian, Bei-Min; Zhang, Xi-Yu; Zhang, Yong-Jie; Dong, Guang-Ying; Lu, Hong; Chu, Qing; Xu, Jie; Yu, Yang; Wu, Rui-Xin; Yin, Yuan; Shi, Songtao; Jin, Yan

2016-02-19

Periodontitis, which progressively destroys tooth-supporting structures, is one of the most widespread infectious diseases and the leading cause of tooth loss in adults. Evidence from preclinical trials and small-scale pilot clinical studies indicates that stem cells derived from periodontal ligament tissues are a promising therapy for the regeneration of lost/damaged periodontal tissue. This study assessed the safety and feasibility of using autologous periodontal ligament stem cells (PDLSCs) as an adjuvant to grafting materials in guided tissue regeneration (GTR) to treat periodontal intrabony defects. Our data provide primary clinical evidence for the efficacy of cell transplantation in regenerative dentistry. We conducted a single-center, randomized trial that used autologous PDLSCs in combination with bovine-derived bone mineral materials to treat periodontal intrabony defects. Enrolled patients were randomly assigned to either the Cell group (treatment with GTR and PDLSC sheets in combination with Bio-oss(®)) or the Control group (treatment with GTR and Bio-oss(®) without stem cells). During a 12-month follow-up study, we evaluated the frequency and extent of adverse events. For the assessment of treatment efficacy, the primary outcome was based on the magnitude of alveolar bone regeneration following the surgical procedure. A total of 30 periodontitis patients aged 18 to 65 years (48 testing teeth with periodontal intrabony defects) who satisfied our inclusion and exclusion criteria were enrolled in the study and randomly assigned to the Cell group or the Control group. A total of 21 teeth were treated in the Control group and 20 teeth were treated in the Cell group. All patients received surgery and a clinical evaluation. No clinical safety problems that could be attributed to the investigational PDLSCs were identified. Each group showed a significant increase in the alveolar bone height (decrease in the bone-defect depth) over time (p < 0.001). However, no statistically significant differences were detected between the Cell group and the Control group (p > 0.05). This study demonstrates that using autologous PDLSCs to treat periodontal intrabony defects is safe and does not produce significant adverse effects. The efficacy of cell-based periodontal therapy requires further validation by multicenter, randomized controlled studies with an increased sample size. NCT01357785 Date registered: 18 May 2011.

Electroacupuncture for chemotherapy-induced peripheral neuropathy: study protocol for a pilot multicentre randomized, patient-assessor-blinded, controlled trial

PubMed Central

2013-01-01

Background Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN. Methods/design This is a multicenter, two-armed, parallel-design, patient-assessor-blinded, randomized, sham-controlled clinical trial. Forty eligible patients with CIPN will be randomized in a ratio of 1:1 to the EA or sham EA arms. During the treatment phase, patients will undergo eight sessions of verum EA or sham EA twice weekly for four weeks, and then will be followed-up for eight weeks. Electrical stimulation in the EA group will consist of a mixed frequency of 2/120 Hz and 80% of bearable intensity. Sham EA will be applied to non-acupoints, with shallow needle insertion and no current. All outcomes and analyses of results will be assessed by researchers blinded to treatment allocation. The effects of EA on CIPN will be evaluated according to both subjective and objective outcome measures. The primary outcome measure will be the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire to assess CIPN (QLQ-CIPN20). The secondary outcome measures will be the results on the numerical rating scale, the Semmes-Weinstein monofilament test, the nerve conduction study, and the EORTC QLQ-C30, as well as the patient’s global impression of change and adverse events. Safety will be assessed at each visit. Discussion The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA. Trial registration Clinical Research Information Service: KCT0000506 PMID:23945074

Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins.

PubMed

Gibson, Kathleen; Morrison, Nick; Kolluri, Raghu; Vasquez, Michael; Weiss, Robert; Cher, Daniel; Madsen, Monte; Jones, Andrew

2018-06-15

We previously reported 3-month and 12-month occlusion rates after treatment of clinically symptomatic saphenous vein reflux with either cyanoacrylate closure (CAC) using the VenaSeal Closure System (Medtronic, Dublin, Ireland) or radiofrequency ablation (RFA) in a randomized, multicenter, clinical trial, VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose). Herein we report the 24-month follow-up results of the VeClose trial. There were 222 patients with symptomatic great saphenous vein (GSV) incompetence who were randomly assigned to receive either CAC (n = 108) or RFA (n = 114). Patients were not allowed to receive adjunctive treatment of tributary varicosities until after the 3-month visit. Duplex ultrasound of the target vein was performed at day 3 and months 1, 3, 6, 12, and 24 after treatment, and closure was assessed by ultrasound by the treating physician. Overall 24-month success rates were compared; in addition, time to first reopening of the target vein was evaluated using survival analysis. End points such as Venous Clinical Severity Score, EuroQoL-5 Dimension, and Aberdeen Varicose Vein Questionnaire were evaluated. Of 222 randomized patients, 171 completed the 24-month follow-up, which included 87 from the CAC group and 84 from the RFA group. The 24-month complete closure rate was 95.3% in the CAC group and 94.0% in the RFA group, demonstrating continued noninferiority of CAC compared with RFA (P = .0034). Symptoms and quality of life improved similarly in both groups. No clinically significant device- or procedure-related late adverse events occurred. Both CAC and RFA were effective in closure of the target GSV, resulting in similar and significant improvements in the patient's quality of life through 24 months. These results suggest that CAC of the GSV is safe and durable out to 2 years. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study).

PubMed

Mendes, Fernanda de Souza Nogueira Sardinha; Sousa, Andréa Silvestre; Souza, Fernando Cesar de Castro Cesar; Pinto, Vivian Liane Mattos; Silva, Paula Simplicio; Saraiva, Roberto Magalhães; Xavier, Sergio Salles; Veloso, Henrique Horta; Holanda, Marcelo Teixeira; Costa, Andréa Rodrigues; Carneiro, Fernanda Martins; Silva, Gilberto Marcelo Sperandio; Borges, Juliana Pereira; Tibirica, Eduardo; Pinheiro, Roberta Olmo; Lara, Flávio Alves; Hasslocher-Moreno, Alejandro Marcel; Brasil, Pedro Emmanuel Alvarenga Americano; Mediano, Mauro Felippe Felix

2016-09-02

The effects of exercise training on Chagas heart disease are still unclear. This study aimed to evaluate the effect of exercise training over functional capacity, cardiac function, quality of life, and biomarkers in Chagas heart disease. The PEACH study is a superiority randomized clinical trial which will include subjects who meet the following criteria: Chagas heart disease with a left ventricular ejection fraction below 45 % with or without heart failure symptoms; clinical stability in the last 3 months; adherence to clinical treatment; and age above 18 years. The exclusion criteria are: pregnancy; neuromuscular limitations; smoking; evidence of non-chagasic heart disease; systemic conditions that limit exercise practice or cardiopulmonary exercise test; unavailability to attend the center three times a week during the intervention period; and practitioners of regular exercise. The intervention group will perform an exercise training intervention three times per week during 6 months and will be compared to the control group without exercise. Both groups will undergo the same monthly pharmaceutical and nutritional counseling as well as standard medical treatment according to the Brazilian consensus on Chagas disease. The primary outcome is functional capacity based on peak exercise oxygen consumption during cardiopulmonary exercise testing. Secondary outcomes are: cardiac function; body composition; muscle respiratory strength; microvascular reactivity; cardiac rhythm abnormalities; autonomic function; biochemical; oxidative stress and inflammatory biomarkers; and quality of life. Subjects will be evaluated at baseline, and at 3 and 6 months after randomization. Thirty patients will be randomly assigned into exercise or control groups at a ratio of 1:1. Findings of the present study will be useful to determine if physical exercise programs should be included as an important additional therapy in the treatment of patients with Chagas heart disease. ClinicalTrials.gov ID: NCT02517632 (registered on 6 August 2015).

ComOn Coaching: Study protocol of a randomized controlled trial to assess the effect of a varied number of coaching sessions on transfer into clinical practice following communication skills training.

PubMed

Niglio de Figueiredo, Marcelo; Rudolph, Bärbel; Rodolph, Bärbel; Bylund, Carma L; Goelz, Tanja; Heußner, Pia; Sattel, Heribert; Fritzsche, Kurt; Wuensch, Alexander

2015-07-07

Communication skills training has proven to be an effective means to enhance communication of health care professionals in oncology. These effects are well studied in standardized settings. The question of transferring these skills into clinical consultations remains open. We build up on a previous developed training concept consisting of a workshop and coaching. This training achieved a medium effect size in two studies with standardized patients. In the current study, we expanded and manualized the coaching concept, and we will evaluate effects of a varied number of coaching sessions on real clinical consultations. Our aim is to determine how much coaching oncologists need to transfer communication skills into clinical practice. Physicians of two German medical centers will participate in a workshop for communication skills and will be randomized to either a group with one coaching session or a group with four coaching sessions following the workshop. The participation is voluntary and the physicians will receive medical education points. Consultations held by the participating physicians with actual patients who gave their informed consent will be filmed at three time points. These consultations will be evaluated by blinded raters using a checklist based on the training content (primary outcome). Secondary outcomes will be the self-evaluated communication competence by physicians and an evaluation of the consultations by both physicians and patients. We will evaluate our communication training concept on three levels - rater, physician and patient - and concentrate on the transfer of communication skills into real life situations. As we emphasize the external validity in this study design, limitations will be expected due to heterogeneity of data. With this study we aim to gain data on how to improve communication skills training that will result in better patient outcomes. German Clinical Trials Register DRKS00004385 .

Evaluation of the Clinical LOINC (Logical Observation Identifiers, Names, and Codes) Semantic Structure as a Terminology Model for Standardized Assessment Measures

PubMed Central

Bakken, Suzanne; Cimino, James J.; Haskell, Robert; Kukafka, Rita; Matsumoto, Cindi; Chan, Garrett K.; Huff, Stanley M.

2000-01-01

Objective: The purpose of this study was to test the adequacy of the Clinical LOINC (Logical Observation Identifiers, Names, and Codes) semantic structure as a terminology model for standardized assessment measures. Methods: After extension of the definitions, 1,096 items from 35 standardized assessment instruments were dissected into the elements of the Clinical LOINC semantic structure. An additional coder dissected at least one randomly selected item from each instrument. When multiple scale types occurred in a single instrument, a second coder dissected one randomly selected item representative of each scale type. Results: The results support the adequacy of the Clinical LOINC semantic structure as a terminology model for standardized assessments. Using the revised definitions, the coders were able to dissect into the elements of Clinical LOINC all the standardized assessment items in the sample instruments. Percentage agreement for each element was as follows: component, 100 percent; property, 87.8 percent; timing, 82.9 percent; system/sample, 100 percent; scale, 92.6 percent; and method, 97.6 percent. Discussion: This evaluation was an initial step toward the representation of standardized assessment items in a manner that facilitates data sharing and re-use. Further clarification of the definitions, especially those related to time and property, is required to improve inter-rater reliability and to harmonize the representations with similar items already in LOINC. PMID:11062226

Topical rapamycin combined with pulsed dye laser in the treatment of capillary vascular malformations in Sturge-Weber syndrome: phase II, randomized, double-blind, intraindividual placebo-controlled clinical trial.

PubMed

Marqués, Laura; Núñez-Córdoba, Jorge M; Aguado, Leyre; Pretel, Maider; Boixeda, Pablo; Nagore, Eduardo; Baselga, Eulalia; Redondo, Pedro

2015-01-01

Sturge-Weber syndrome (SWS) is characterized by port-wine stains (PWS) affecting the face, eyes, and central nervous system. Pulsed dye laser (PDL) is the standard treatment for PWS. Unfortunately, recurrence is frequent because of reformation and reperfusion of blood vessels. We sought to assess the clinical efficacy of topical rapamycin combined with PDL in PWS of patients with SWS. We conducted a phase II, randomized, double-blind, intraindividual placebo-controlled, clinical trial. We recruited 23 patients with SWS and facial PWS (12 women; median age 33 years, age range 17-65 years) from the University Clinic of Navarra, Spain. Four interventions were evaluated: placebo, PDL + placebo, rapamycin, and PDL + rapamycin. Clinical and histologic responses were evaluated using a chromatographic computerized system, spectrometry, and histologic analyses at 6, 12, and 18 weeks after the intervention. PDL + rapamycin yielded the lowest digital photographic image score and the lowest percentage of vessels in histologic analysis, and showed a statistically significant improvement compared with the other interventions. The treatment was generally well tolerated. PDL was only applied to the lateral parts of the PWS area. Topical rapamycin associated with PDL seems to be an effective treatment for PWS in patients with SWS. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

A randomized clinical trial evaluating plasma rich in growth factors (PRGF-Endoret) versus hyaluronic acid in the short-term treatment of symptomatic knee osteoarthritis.

PubMed

Sánchez, Mikel; Fiz, Nicolás; Azofra, Juan; Usabiaga, Jaime; Aduriz Recalde, Enmanuel; Garcia Gutierrez, Antonio; Albillos, Javier; Gárate, Ramón; Aguirre, Jose Javier; Padilla, Sabino; Orive, Gorka; Anitua, Eduardo

2012-08-01

This multicenter, double-blind clinical trial evaluated and compared the efficacy and safety of PRGF-Endoret (BTI Biotechnology Institute, Vitoria-Gasteiz, Spain), an autologous biological therapy for regenerative purposes, versus hyaluronic acid (HA) as a short-term treatment for knee pain from osteoarthritis. We randomly assigned 176 patients with symptomatic knee osteoarthritis to receive infiltrations with PRGF-Endoret or with HA (3 injections on a weekly basis). The primary outcome measure was a 50% decrease in knee pain from baseline to week 24. As secondary outcomes, we also assessed pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index; the rate of response using the criteria of the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI); and safety. The mean age of the patients was 59.8 years, and 52% were women. Compared with the rate of response to HA, the rate of response to PRGF-Endoret was 14.1 percentage points higher (95% confidence interval, 0.5 to 27.6; P = .044). Regarding the secondary outcome measures, the rate of response to PRGF-Endoret was higher in all cases, although no significant differences were reached. Adverse events were mild and evenly distributed between the groups. Plasma rich in growth factors showed superior short-term results when compared with HA in a randomized controlled trial, with a comparable safety profile, in alleviating symptoms of mild to moderate osteoarthritis of the knee. Level I, randomized controlled multicenter trial. Copyright © 2012 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

A patient-centered clinical evaluation of acellular dermal matrix graft in the treatment of gingival recession defects.

PubMed

Mahajan, Ajay; Dixit, Jaya; Verma, Umesh Pratap

2007-12-01

The present randomized controlled trial was conducted to evaluate acellular dermal matrix (ADM) graft in terms of patient satisfaction and its effectiveness and efficiency in the treatment of gingival recession. Fourteen patients (seven males and seven females) with Miller Class I and II recessions > or =3 mm participated in this 6-month clinical study. They were assigned randomly to the ADM group (ADM graft and coronally positioned flap [CPF]) or the CPF group (CPF alone). Results were evaluated based on parameters measuring patient satisfaction and clinical outcomes associated with the two treatment procedures. Significance was set at P <0.05. The mean recession was 4.0 +/- 1.0 mm and 3.7 +/- 0.7 mm for the ADM and CPF groups, respectively. For the ADM group, the defect coverage was 3.85 +/- 0.89 mm or 97.14% compared to the CPF group, in which the defect coverage was 2.85 +/- 0.89 mm or 77.42%. The difference between the two groups was statistically significant (P <0.05). There were no statistically significant differences between the two groups in the remaining clinical parameters and overall patient satisfaction except in criteria related to patient comfort and cost effectiveness, in which CPF alone produced significantly better results (P <0.03). ADM graft is significantly superior with regard to effectiveness and efficiency in the treatment of gingival recession than CPF alone. CPF emerges as a better option than ADM graft in terms of cost effectiveness and patient comfort.

Aloe vera herbal dentifrices for plaque and gingivitis control: a systematic review.

PubMed

Dhingra, K

2014-04-01

To evaluate the effectiveness of aloe vera containing herbal dentifrices in improving plaque control and gingival health. A manual and electronic literature (MEDLINE and Cochrane Central Register of Controlled Trials) search was performed up to July 2012, for randomized controlled trials presenting clinical, microbiological, immunological, and patient-centered data for the efficacy of aloe vera herbal dentifrices for controlling plaque and gingival inflammation in patients with gingivitis. From 79 titles and abstracts, eight full-text articles were screened and finally two randomized controlled trials were selected. These randomized controlled trials reported that aloe vera dentifrices were similar in efficacy to control dentifrices in effectively reducing plaque and gingival inflammation in gingivitis patients based on the assessment of clinical, microbiological, and patient-centered treatment outcomes. However, many important details (composition and characteristics of aloe vera and control dentifrices along with appropriate randomization, blinding, and outcomes assessed) were lacking in these trials, and therefore, the quality of reporting and methods was generally flawed with high risk of bias. Even though there are some promising results, the clinical effectiveness of aloe vera herbal dentifrices is not sufficiently defined at present and warrants further investigations based on reporting guidelines of herbal CONSORT statement. © 2013 John Wiley & Sons A/S.

Effect of surgical periodontal treatment associated to antimicrobial photodynamic therapy on chronic periodontitis: A randomized controlled clinical trial.

PubMed

Martins, Sérgio H L; Novaes, Arthur B; Taba, Mario; Palioto, Daniela B; Messora, Michel R; Reino, Danilo M; Souza, Sérgio L S

2017-07-01

This randomized controlled clinical trial evaluated the effects of an adjunctive single application of antimicrobial photodynamic therapy (aPDT) in Surgical Periodontal Treatment (ST) in patients with severe chronic periodontitis (SCP). In a split-mouth design, 20 patients with SCP were treated with aPDT+ST (Test Group, TG) or ST only (Control Group, CG). aPDT was applied in a single episode, using a diode laser and a phenothiazine photosensitizer. All patients were monitored until 90 days after surgical therapy. Levels of 40 subgingival species were measured by checkerboard DNA-DNA hybridization at baseline, 60 and 150 days. Clinical and microbiological parameters were evaluated. In deep periodontal pockets depth (PPD ≥5 mm), Test Group presented a significantly higher decrease in PPD than Control Group at 90 days after surgical therapy (p < .05). Test Group also demonstrated significantly less periodontal pathogens of red complex (Treponema denticola) (p < .05). A single episode of aPDT used in adjunct to open flap debridement of the root surface in the surgical treatment of SCP: i) significantly improved clinical periodontal parameters; ii) eliminates periodontal pathogens of the red complex more effectively (NCT02734784). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

PubMed Central

Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

2015-01-01

Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications. Conclusion We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second generation antipsychotic with broad-spectrum activity in bipolar disorder and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial. PMID:24346608

Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.

PubMed

Nierenberg, Andrew A; Sylvia, Louisa G; Leon, Andrew C; Reilly-Harrington, Noreen A; Shesler, Leah W; McElroy, Susan L; Friedman, Edward S; Thase, Michael E; Shelton, Richard C; Bowden, Charles L; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence A; Kocsis, James H; McInnis, Melvin G; Schoenfeld, David; Bobo, William V; Calabrese, Joseph R

2014-02-01

Classic and second-generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the 'real-world' advantages and disadvantages of these medications. We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This article outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments (APTs). The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score, and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT). The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus APT, across 10 sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. In all, 482 participants were randomized to the study, and 364 completed the study. The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants' ability to pay for study medications. We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second-generation antipsychotic with broad-spectrum activity in bipolar disorder, and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial.

Clinical performance of stem cell therapy in patients with acute-on-chronic liver failure: a systematic review and meta-analysis.

PubMed

Xue, Ran; Meng, Qinghua; Dong, Jinling; Li, Juan; Yao, Qinwei; Zhu, Yueke; Yu, Hongwei

2018-05-10

Stem cell therapy has been applied in the treatment of acute-on-chronic liver failure (ACLF). However, its clinical efficiency is still debatable. The aim of this systematic review and meta-analysis is to evaluate the clinical efficiency of stem cell therapy in the treatment of ACLF. The Cochrane Library, OVID, EMBASE, and PUBMED were searched to December 2017. Both randomized and non-randomized studies, assessing stem cell therapy in patients with ACLF, were included. The outcome measures were total bilirubin (TBIL), alanine transaminase (ALT), international normalized ratio (INR), albumin (ALB), and the model for end-stage liver disease (MELD) score. The quality of evidence was assessed by GRADEpro. Four randomized controlled trials and six non-randomized controlled trials were included. The TBIL levels significantly decreased at 1-, 3-, 12-month after the stem cell therapy (p = 0.0008; p = 0.04; p = 0.007). The ALT levels decreased significantly compared with the control group in the short-term (p < 0.00001). There was no obvious change in the INR level compared with the control groups (p = 0.64). The ALB levels increased markedly as compared with the control groups (p < 0.0001). The significant difference can be found in MELD score between stem cell therapy and control groups (p = 0.008). Further subgroup analysis for 3-month clinical performance according to the stem cell types have also been performed. This study suggests that the clinical outcomes of stem cell therapy were satisfied in patients with ACLF in the short-term. MSCs may be better than BM-MNCs in the stem cells transplantation of ACLF. However, more attention should focus on clinical trials in large-volume centers.

Rotator cuff healing after needling of a calcific deposit using platelet-rich plasma augmentation: a randomized, prospective clinical trial.

PubMed

Verhaegen, Filip; Brys, Peter; Debeer, Philippe

2016-02-01

Arthroscopic needling of a rotator cuff calcification is a highly reliable operation in terms of pain relief and return of function. However, during the needling process, a cuff defect is created. Little is known about the evolution of this defect. We conducted a prospective, randomized controlled clinical trial to investigate the evolution of the aforementioned defect and the role of platelet-rich plasma (PRP) augmentation in this healing process. Patients were randomized to either group 1 (PRP, n = 20) or group 2 (no PRP [control group], n = 20). Patients in group 1 received a perioperative PRP infiltration at the rotator cuff defect, whereas the control group did not. Patients were assessed clinically preoperatively and postoperatively at 6 weeks, 3 and 6 months, and 1 year. The Constant score, Simple Shoulder Test, and QuickDASH (short version of Disabilities of the Arm, Shoulder and Hand questionnaire) were used as outcome measures. The evolution of the cuff defect was evaluated on sonography at 3 and 6 months and with magnetic resonance imaging after 1 year. All patients improved significantly after surgery (P < .05). There was no difference in clinical outcome or rotator cuff healing between groups. We observed a high rate of persistent rotator cuff defects after 1 year in both groups. The presence of residual cuff defects did not influence the clinical outcome. Arthroscopic needling is an operation with a predictive, good clinical outcome. We found a high rate of persistent rotator cuff defects after 1 year. This study could not identify any beneficial effect of the addition of PRP on rotator cuff healing. Level II; Randomized Controlled Trial; Treatment Study. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Evaluation of Effectiveness and Cost‐Effectiveness of a Clinical Decision Support System in Managing Hypertension in Resource Constrained Primary Health Care Settings: Results From a Cluster Randomized Trial

PubMed Central

Anchala, Raghupathy; Kaptoge, Stephen; Pant, Hira; Di Angelantonio, Emanuele; Franco, Oscar H.; Prabhakaran, D.

2015-01-01

Background Randomized control trials from the developed world report that clinical decision support systems (DSS) could provide an effective means to improve the management of hypertension (HTN). However, evidence from developing countries in this regard is rather limited, and there is a need to assess the impact of a clinical DSS on managing HTN in primary health care center (PHC) settings. Methods and Results We performed a cluster randomized trial to test the effectiveness and cost‐effectiveness of a clinical DSS among Indian adult hypertensive patients (between 35 and 64 years of age), wherein 16 PHC clusters from a district of Telangana state, India, were randomized to receive either a DSS or a chart‐based support (CBS) system. Each intervention arm had 8 PHC clusters, with a mean of 102 hypertensive patients per cluster (n=845 in DSS and 783 in CBS groups). Mean change in systolic blood pressure (SBP) from baseline to 12 months was the primary endpoint. The mean difference in SBP change from baseline between the DSS and CBS at the 12th month of follow‐up, adjusted for age, sex, height, waist, body mass index, alcohol consumption, vegetable intake, pickle intake, and baseline differences in blood pressure, was −6.59 mm Hg (95% confidence interval: −12.18 to −1.42; P=0.021). The cost‐effective ratio for CBS and DSS groups was $96.01 and $36.57 per mm of SBP reduction, respectively. Conclusion Clinical DSS are effective and cost‐effective in the management of HTN in resource‐constrained PHC settings. Clinical Trial Registration URL: http://www.ctri.nic.in. Unique identifier: CTRI/2012/03/002476. PMID:25559011

A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease.

PubMed

Ostrowitzki, Susanne; Lasser, Robert A; Dorflinger, Ernest; Scheltens, Philip; Barkhof, Frederik; Nikolcheva, Tania; Ashford, Elizabeth; Retout, Sylvie; Hofmann, Carsten; Delmar, Paul; Klein, Gregory; Andjelkovic, Mirjana; Dubois, Bruno; Boada, Mercè; Blennow, Kaj; Santarelli, Luca; Fontoura, Paulo

2017-12-08

Gantenerumab is a fully human monoclonal antibody that binds aggregated amyloid-β (Aβ) and removes Aβ plaques by Fc receptor-mediated phagocytosis. In the SCarlet RoAD trial, we assessed the efficacy and safety of gantenerumab in prodromal Alzheimer's disease (AD). In this randomized, double-blind, placebo-controlled phase III study, we investigated gantenerumab over 2 years. Patients were randomized to gantenerumab 105 mg or 225 mg or placebo every 4 weeks by subcutaneous injection. The primary endpoint was the change from baseline to week 104 in Clinical Dementia Rating Sum of Boxes (CDR-SB) score. We evaluated treatment effects on cerebrospinal fluid biomarkers (all patients) and amyloid positron emission tomography (substudy). A futility analysis was performed once 50% of patients completed 2 years of treatment. Safety was assessed in patients who received at least one dose. Of the 3089 patients screened, 797 were randomized. The study was halted early for futility; dosing was discontinued; and the study was unblinded. No differences between groups in the primary (least squares mean [95% CI] CDR-SB change from baseline 1.60 [1.28, 1.91], 1.69 [1.37, 2.01], and 1.73 [1.42, 2.04] for placebo, gantenerumab 105 mg, and gantenerumab 225 mg, respectively) or secondary clinical endpoints were observed. The incidence of generally asymptomatic amyloid-related imaging abnormalities increased in a dose- and APOE ε4 genotype-dependent manner. Exploratory analyses suggested a dose-dependent drug effect on clinical and biomarker endpoints. The study was stopped early for futility, but dose-dependent effects observed in exploratory analyses on select clinical and biomarker endpoints suggest that higher dosing with gantenerumab may be necessary to achieve clinical efficacy. ClinicalTrials.gov, NCT01224106 . Registered on October 14, 2010.

Financial Management of a Large Multi-site Randomized Clinical Trial

PubMed Central

Sheffet, Alice J.; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E.; Longbottom, Mary E.; Howard, Virginia J.; Marler, John R.; Brott, Thomas G.

2014-01-01

Background The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years’ funding ($21,112,866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2,500 randomized participants at 40 sites. Aims Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods Projections of the original grant’s fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant’s fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2,500 targeted sample size, 138 (5.5%) were randomized during the first five years and 1,387 (55.5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13,845) of the projected per-patient costs ($152,992) of the fixed model. Conclusions Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. PMID:24661748

Financial management of a large multisite randomized clinical trial.

PubMed

Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G

2014-08-01

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials

PubMed Central

Yuan, Jing; Liu, Fenghua

2017-01-01

Objective The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Methods Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Results Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94–1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06–1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80–1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Conclusions Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use. PMID:28570713

Publications in anesthesia journals: quality and clinical relevance.

PubMed

Lauritsen, Jakob; Moller, Ann M

2004-11-01

Clinicians performing evidence-based anesthesia rely on anesthesia journals for clinically relevant information. The objective of this study was to analyze the proportion of clinically relevant articles in five high impact anesthesia journals. We evaluated all articles published in Anesthesiology, Anesthesia & Analgesia, British Journal of Anesthesia, Anesthesia, and Acta Anaesthesiologica Scandinavica from January to June, 2000. Articles were assessed and classified according to type, outcome, and design; 1379 articles consisting of 5468 pages were evaluated and categorized. The most common types of article were animal and laboratory research (31.2%) and randomized clinical trial (20.4%). A clinically relevant article was defined as an article that used a statistically valid method and had a clinically relevant end-point. Altogether 18.6% of the pages had as their subject matter clinically relevant trials. We compared the Journal Impact Factor (a measure of the number of citations per article in a journal) and the proportion of clinically relevant pages and found that they were inversely proportional to each other.

Effect of magnesium added to local anesthetics for caudal anesthesia on postoperative pain in pediatric surgical patients: A systematic review and meta-analysis with Trial Sequential Analysis

PubMed Central

Mihara, Takahiro; Nakamura, Nobuhito; Ka, Koui; Goto, Takahisa

2018-01-01

Background Magnesium has been investigated as an adjuvant for neuraxial anesthesia, but the effect of caudal magnesium on postoperative pain is inconsistent. The aim of this systematic review and meta-analysis was to evaluate the analgesic effect of caudal magnesium. Methods We searched six databases, including trial registration sites. Randomized clinical trials reporting the effect of caudal magnesium on postoperative pain after general anesthesia were eligible. The risk ratio for use of rescue analgesics after surgery was combined using a random-effects model. We also assessed adverse events. The I2 statistic was used to assess heterogeneity. We assessed risk of bias with Cochrane domains. We controlled type I and II errors due to sparse data and repetitive testing with Trial Sequential Analysis. We assessed the quality of evidence with GRADE. Results Four randomized controlled trials (247 patients) evaluated the need for rescue analgesics. In all four trials, 50 mg of magnesium was administered with caudal ropivacaine. The results suggested that the need for rescue analgesia was reduced significantly by caudal magnesium administration (risk ratio 0.45; 95% confidence interval 0.24–0.86). There was considerable heterogeneity as indicated by an I2 value of 62.5%. The Trial Sequential Analysis-adjusted confidence interval was 0.04–5.55, indicating that further trials are required. The quality of evidence was very low. The rate of adverse events was comparable between treatment groups. Conclusion Caudal magnesium may reduce the need for rescue analgesia after surgery, but further randomized clinical trials with a low risk of bias and a low risk of random errors are necessary to assess the effect of caudal magnesium on postoperative pain and adverse events. Trial registration University Hospital Medical Information Network Clinical Trials Registry UMIN000025344. PMID:29293586

Lifestyle Modification for Resistant Hypertension: The TRIUMPH Randomized Clinical Trial

PubMed Central

Blumenthal, James A.; Sherwood, Andrew; Smith, Patrick J.; Mabe, Stephanie; Watkins, Lana; Lin, Pao-Hwa; Craighead, Linda W.; Babyak, Michael; Tyson, Crystal; Young, Kenlyn; Ashworth, Megan; Kraus, William; Liao, Lawrence; Hinderliter, Alan

2015-01-01

Background Resistant hypertension (RH) is a growing health burden in this country affecting as many as one in five adults being treated for hypertension. RH is associated with increased risk of adverse cardiovascular disease (CVD) events and all-cause mortality. Strategies to reduce blood pressure in this high risk population are a national priority. Methods TRIUMPH is a single site, prospective, randomized clinical trial (RCT) to evaluate the efficacy of a center-based lifestyle intervention consisting of exercise training, reduced sodium and calorie DASH eating plan, and weight management compared to standardized education and physician advice in treating patients with RH. Patients (N=150) will be randomized in a 2:1 ratio to receive either a 4-month supervised lifestyle intervention delivered in the setting of a cardiac rehabilitation center or to a standardized behavioral counseling session to simulate real-world medical practice. The primary end point is clinic blood pressure; secondary endpoints include ambulatory blood pressure and an array of CVD biomarkers including left ventricular hypertrophy, arterial stiffness, baroreceptor reflex sensitivity, insulin resistance, lipids, sympathetic nervous system activity, and inflammatory markers. Lifestyle habits, blood pressure and CVD risk factors also will be measured at one year follow-up. Conclusions The TRIUMPH randomized clinical trial (ClinicalTrials.gov NCT02342808) is designed to test the efficacy of an intensive, center-based lifestyle intervention compared to a standardized education and physician advice counseling session on blood presssure and CVD biomarkers in patients with RH after 4 months of treatment, and will determine whether lifestyle changes can be maintained for a year. PMID:26542509

Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials

PubMed Central

Zabetian, Azadeh; Ferket, Bart S.; Zhou, Jing; Testani, Jeffrey M.; Garg, Amit X.; Parikh, Chirag R.

2016-01-01

Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short–term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between–group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo–controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. PMID:26712525

Comparing the effects of ketotifen fumarate eye drops and ketotifen oral pills on symptom severity and quality of life in patients with allergic rhinitis: a double-blind randomized clinical trial.

PubMed

Akhavan, Asghar; Karimi-Sari, Hamidreza; Khosravi, Mohammad Hossein; Arefzadeh, Esmaeil; Yavarahmadi, Mohammadhosein

2015-05-01

Allergic rhinitis is a chronic inflammatory disease of nasal mucosa. Previous studies have shown the therapeutic effects of ketotifen eye drops on allergic conjunctivitis and rhinitis patients. This study was designed to compare the effects of ketotifen drops and oral ketotifen pills on symptoms and quality of life in allergic rhinitis patients. In this double-blind randomized clinical trial, patients with mild allergic rhinitis who were referred to the allergy clinic of Baqiyatallah Hospital from March to April 2014 were randomly allocated to 2 groups; the first group received ketotifen drops (1 drop every 12 hours) with placebo pills (2 pills daily), and the second group received placebo eye drops with ketotifen pills for 4 weeks. Symptoms (sneezing, runny nose, itching, and nasal obstruction) severity were examined and Rhinitis Quality of Life Questionnaire (RQLQ) scores were evaluated in the second and fourth weeks. A total of 140 patients were evaluated in 2 groups. The mean age was 30.33 years. There were no significant differences in demographic data between the groups (p > 0.05). Both groups showed a significant improvement in rhinorrhea, nasal congestion, nasal itching, coughing, sneezing, RQLQ, and nasal smear eosinophil percent compared to baseline amounts (p < 0.05). Improvements were significantly more in the drops group (p < 0.05). Because of the absence of systemic complications in ketotifen eye drops in patients with allergic rhinitis and their easy availability in Iran, using this medication instead of systemic therapies is suggested. Nevertheless, more studies are required to evaluate the long-term effects of using this drug and the recurrence rate of symptoms. © 2015 ARS-AAOA, LLC.

Clinical and microbiological effectiveness of photodynamic therapy on primary endodontic infections: a 6-month randomized clinical trial.

PubMed

de Miranda, Rachel Garcia; Colombo, Ana Paula Vieira

2018-05-01

This short-term randomized controlled trial evaluated the effectiveness of photodynamic therapy (PDT) on clinical success (periapical healing) and on the microbiota of primary endodontic infections. Thirty-two patients presenting mandibular molars with apical periodontitis (one tooth/patient) were selected and randomly allocated into two therapeutic groups: control (chemo-mechanical debridement [CMD]; n = 16) and PDT (CMD + PDT; n = 16). All teeth in both groups had intracanal medication with calcium hydroxide for 7 days before final obturation. Follow-up radiographs were made at 3 and 6 months. Periapical healing was evaluated by the periapical index (PAI). Samples were obtained at baseline, after CMD with or without PDT, and just before root filling to determine the frequency and levels of 37 taxa by checkerboard. Significant decreases in PAI scores were observed in both groups over time, although at 6 months, the PDT group presented a significantly better healing score than the control (p < 0.05). At baseline, the most prevalent species in all samples were Candida albicans (46.9%), Dialister pneumosintes (31.2%), Prevotella nigrescens (28.2%), Prevotella tannerae (28.1%), and Peptostreptococcus anaerobius (25%). Most species reduced over time in both groups, and no significant differences in frequency and levels of the tested species were observed between groups in any time point evaluated. C. albicans and D. pneumosintes were still detected in high frequency in both groups at 3 months post-therapy. Conventional endodontic therapy with or without PDT is effective in reducing microbial load, resulting in periapical healing. Nevertheless, adjunctive PDT provides better periapical healing at 6-month follow-up. Teeth with apical periodontitis treated with PDT adjunct to conventional treatment would demonstrate superior healing and reduction of microorganisms.

TD-1792 versus Vancomycin for Treatment of Complicated Skin and Skin Structure Infections

PubMed Central

Potgieter, Peter D.; Li, Yu-Ping; Barriere, Steven L.; Churukian, Allan; Kingsley, Jeff; Corey, G. Ralph

2012-01-01

TD-1792 is a first-in-class glycopeptide-cephalosporin heterodimer that exhibits bactericidal activity against Gram-positive pathogens. We conducted a randomized, double-blind, active-control, phase II trial in patients with complicated skin and skin structure infections caused by suspected or confirmed Gram-positive organisms. Patients 18 to 65 years old were randomized to receive 7 to 14 days of either TD-1792 (2 mg/kg of body weight intravenously [i.v.] every 24 h [q24h]) or vancomycin (1 g i.v. q12h, with dosage regimens adjusted per site-specific procedures). A total of 197 patients were randomized and received at least one dose of study medication. Rates of clinical success at the test-of-cure evaluation were similar in all analysis populations. Among 170 clinically evaluable patients, cure rates were 91.7% and 90.7% in the TD-1792 and vancomycin groups, respectively (95% confidence interval [CI] of −7.9 to 9.7 for the difference). In microbiologically evaluable patients with methicillin-resistant Staphylococcus aureus at baseline (n = 75), cure rates were 94.7% in the TD-1792 group and 91.9% in the vancomycin group. Microbiological eradication of Gram-positive pathogens (n = 126) was achieved in 93.7% and 92.1% of patients in the TD-1792 and vancomycin groups, respectively. Seven patients were discontinued from study medication due to an adverse event (AE): 2 and 5 in the TD-1792 and vancomycin groups, respectively. AEs were of similar types and severities between the two groups, other than pruritus, which was more common in patients who received vancomycin. No patients in the TD-1792 group experienced a serious AE. This study supports further clinical development of TD-1792 in patients with Gram-positive infection. PMID:22869571

A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases.

PubMed

El-Hamamsy, Manal; Elwakil, Hesham; Saad, Amr S; Shawki, May A

2016-10-27

Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.

Randomized phase III trial of postoperative radiochemotherapy +/- amifostine in head and neck cancer. Is there evidence for radioprotection?

PubMed

Vacha, Peter; Fehlauer, Fabian; Mahlmann, Birgit; Marx, Meinolf; Hinke, Axel; Sommer, Konrad; Richter, Eckart; Feyerabend, Thomas

2003-06-01

Experimental and clinical data suggest a reduction of radiation-induced acute toxicity by amifostine (A). We investigated this issue in a randomized trial comparing radiochemotherapy (RT + CT) versus radiochemotherapy plus amifostine (RC + CT + A) in patients with head and neck cancer. 56 patients with oro-/hypopharynx or larynx cancer (T1-2 N1-2 G3, T3-4 N0-2 G1-3) were randomized to receive RC + CT alone or RC + CT + A. Patients were irradiated up to 60 Gy (R0) or 70 Gy (R1/2) and received chemotherapy (70 mg/m(2) carboplatin, day 1-5 in week 1 and 5 of radiotherapy). 250 mg amifostine were applied daily before each radiotherapy session. Acute toxicity was evaluated according to the Common Toxicity Criteria (CTC). As for acute xerostomia, patients with laryngeal cancer were excluded from evaluation. 50 patients were evaluable (25 patients in the RC + CT, 25 patients in the RC + CT + A group). Clinical characteristics were well balanced in both treatment groups. Amifostine provided reduction in acute xerostomia and mucositis but had no obvious influence on Karnofsky performance status, body weight, cutaneous side effects, and alopecia. The differences between both groups were statistically significant for acute xerostomia and nonsignificant, but with a trend for mucositis. According to our results, there is a radioprotective effect on salivary glands and a potential effect on oral mucosa by amifostine in postoperative radiotherapy combined with carboplatin. To improve the radio- and chemoprotective effects of amifostine in clinical practice, the application of a higher dose (> 250 mg) seems to be necessary.

The Memory Aid study: protocol for a randomized controlled clinical trial evaluating the effect of computer-based working memory training in elderly patients with mild cognitive impairment (MCI)

PubMed Central

2014-01-01

Background Mild cognitive impairment (MCI) is a condition characterized by memory problems that are more severe than the normal cognitive changes due to aging, but less severe than dementia. Reduced working memory (WM) is regarded as one of the core symptoms of an MCI condition. Recent studies have indicated that WM can be improved through computer-based training. The objective of this study is to evaluate if WM training is effective in improving cognitive function in elderly patients with MCI, and if cognitive training induces structural changes in the white and gray matter of the brain, as assessed by structural MRI. Methods/Designs The proposed study is a blinded, randomized, controlled trail that will include 90 elderly patients diagnosed with MCI at a hospital-based memory clinic. The participants will be randomized to either a training program or a placebo version of the program. The intervention is computerized WM training performed for 45 minutes of 25 sessions over 5 weeks. The placebo version is identical in duration but is non-adaptive in the difficulty level of the tasks. Neuropsychological assessment and structural MRI will be performed before and 1 month after training, and at a 5-month folllow-up. Discussion If computer-based training results in positive changes to memory functions in patients with MCI this may represent a new, cost-effective treatment for MCI. Secondly, evaluation of any training-induced structural changes to gray or white matter will improve the current understanding of the mechanisms behind effective cognitive interventions in patients with MCI. Trial registration ClinicalTrials.gov NCT01991405. November 18, 2013. PMID:24886034

Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure: Rationale and Design of the Randomized Trial to REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I).

PubMed

Feldman, Ted; Komtebedde, Jan; Burkhoff, Daniel; Massaro, Joseph; Maurer, Mathew S; Leon, Martin B; Kaye, David; Silvestry, Frank E; Cleland, John G F; Kitzman, Dalane; Kubo, Spencer H; Van Veldhuisen, Dirk J; Kleber, Franz; Trochu, Jean-Noël; Auricchio, Angelo; Gustafsson, Finn; Hasenfuβ, Gerd; Ponikowski, Piotr; Filippatos, Gerasimos; Mauri, Laura; Shah, Sanjiv J

2016-07-01

Heart failure with preserved ejection fraction (HFpEF), a major public health problem with high morbidity and mortality rates, remains difficult to manage because of a lack of effective treatment options. Although HFpEF is a heterogeneous clinical syndrome, elevated left atrial pressure-either at rest or with exertion-is a common factor among all forms of HFpEF and one of the primary reasons for dyspnea and exercise intolerance in these patients. On the basis of clinical experience with congenital interatrial shunts in mitral stenosis, it has been hypothesized that the creation of a left-to-right interatrial shunt to decompress the left atrium (without compromising left ventricular filling or forward cardiac output) is a rational, nonpharmacological strategy for alleviating symptoms in patients with HFpEF. A novel transcatheter interatrial shunt device has been developed and evaluated in patients with HFpEF in single-arm, nonblinded clinical trials. These studies have demonstrated the safety and potential efficacy of the device. However, a randomized, placebo-controlled evaluation of the device is required to further evaluate its safety and efficacy in patients with HFpEF. In this article, we give the rationale for a therapeutic transcatheter interatrial shunt device in HFpEF, and we describe the design of REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I), the first randomized controlled trial of a device-based therapy to reduce left atrial pressure in HFpEF. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02600234. © 2016 American Heart Association, Inc.

The Memory Aid study: protocol for a randomized controlled clinical trial evaluating the effect of computer-based working memory training in elderly patients with mild cognitive impairment (MCI).

PubMed

Flak, Marianne M; Hernes, Susanne S; Chang, Linda; Ernst, Thomas; Douet, Vanessa; Skranes, Jon; Løhaugen, Gro C C

2014-05-03

Mild cognitive impairment (MCI) is a condition characterized by memory problems that are more severe than the normal cognitive changes due to aging, but less severe than dementia. Reduced working memory (WM) is regarded as one of the core symptoms of an MCI condition. Recent studies have indicated that WM can be improved through computer-based training. The objective of this study is to evaluate if WM training is effective in improving cognitive function in elderly patients with MCI, and if cognitive training induces structural changes in the white and gray matter of the brain, as assessed by structural MRI. The proposed study is a blinded, randomized, controlled trail that will include 90 elderly patients diagnosed with MCI at a hospital-based memory clinic. The participants will be randomized to either a training program or a placebo version of the program. The intervention is computerized WM training performed for 45 minutes of 25 sessions over 5 weeks. The placebo version is identical in duration but is non-adaptive in the difficulty level of the tasks. Neuropsychological assessment and structural MRI will be performed before and 1 month after training, and at a 5-month folllow-up. If computer-based training results in positive changes to memory functions in patients with MCI this may represent a new, cost-effective treatment for MCI. Secondly, evaluation of any training-induced structural changes to gray or white matter will improve the current understanding of the mechanisms behind effective cognitive interventions in patients with MCI. ClinicalTrials.gov NCT01991405. November 18, 2013.

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial.

PubMed

Norman, Wendy V; Kaczorowski, Janusz; Soon, Judith A; Brant, Rollin; Bryan, Stirling; Trouton, Konia J; Dicus, Lyda

2011-06-14

We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion.

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Methods/Design Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. Discussion The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Trial registration Current Controlled Trials ISRCTN19506752 PMID:21672213

To evaluate if increased supervision and support of South African Government health workers' home visits improves maternal and child outcomes: study protocol for a randomized control trial.

PubMed

Rotheram-Borus, Mary Jane; Le Roux, Karl; Le Roux, Ingrid M; Christodoulou, Joan; Laurenzi, Christina; Mbewu, Nokwanele; Tomlinson, Mark

2017-08-07

Concurrent epidemics of HIV, depression, alcohol abuse, and partner violence threaten maternal and child health (MCH) in South Africa. Although home visiting has been repeatedly demonstrated efficacious in research evaluations, efficacy disappears when programs are scaled broadly. In this cluster randomized controlled trial (RCT), we examine whether the benefits of ongoing accountability and supervision within an existing government funded and implemented community health workers (CHW) home visiting program ensure the effectiveness of home visiting. In the deeply rural, Eastern Cape of South Africa, CHW will be hired by the government and will be initially trained by the Philani Programme to conduct home visits with all pregnant mothers and their children until the children are 2 years old. Eight clinics will be randomized to receive either (1) the Accountable Care Condition in which additional monitoring and accountability systems that Philani routinely uses are implemented (4 clinics, 16 CHW, 450 households); or (2) a Standard Care Condition of initial Philani training, but with supervision and monitoring being delivered by local government structures and systems (4 clinics, 21 CHW, 450 households). In the Accountable Care Condition areas, the CHW's mobile phone reports, which are time-location stamped, will be monitored and data-informed supervision will be provided, as well as monitoring growth, medical adherence, mental health, and alcohol use outcomes. Interviewers will independently assess outcomes at pregnancy at 3, 6, 15, and 24 months post-birth. The primary outcome will be a composite score of documenting maternal HIV/TB testing, linkage to care, treatment adherence and retention, as well as child physical growth, cognitive functioning, and child behavior and developmental milestones. The proposed cluster RCT will evaluate whether routinely implementing supervision and accountability procedures and monitoring CHWs' over time will improve MCH outcomes over the first 2 years of life. ClinicalTrials.gov registration #NCT02957799 , registered on October 26, 2016.

Tools to Promote Shared Decision Making in Serious Illness: A Systematic Review.

PubMed

Austin, C Adrian; Mohottige, Dinushika; Sudore, Rebecca L; Smith, Alexander K; Hanson, Laura C

2015-07-01

Serious illness impairs function and threatens survival. Patients facing serious illness value shared decision making, yet few decision aids address the needs of this population. To perform a systematic review of evidence about decision aids and other exportable tools that promote shared decision making in serious illness, thereby (1) identifying tools relevant to the treatment decisions of seriously ill patients and their caregivers, (2) evaluating the quality of evidence for these tools, and (3) summarizing their effect on outcomes and accessibility for clinicians. We searched PubMed, CINAHL, and PsychInfo from January 1, 1995, through October 31, 2014, and identified additional studies from reference lists and other systematic reviews. Clinical trials with random or nonrandom controls were included if they tested print, video, or web-based tools for advance care planning (ACP) or decision aids for serious illness. We extracted data on the study population, design, results, and risk for bias using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. Each tool was evaluated for its effect on patient outcomes and accessibility. Seventeen randomized clinical trials tested decision tools in serious illness. Nearly all the trials were of moderate or high quality and showed that decision tools improve patient knowledge and awareness of treatment choices. The available tools address ACP, palliative care and goals of care communication, feeding options in dementia, lung transplant in cystic fibrosis, and truth telling in terminal cancer. Five randomized clinical trials provided further evidence that decision tools improve ACP documentation, clinical decisions, and treatment received. Clinicians can access and use evidence-based tools to engage seriously ill patients in shared decision making. This field of research is in an early stage; future research is needed to develop novel decision aids for other serious diagnoses and key decisions. Health care delivery organizations should prioritize the use of currently available tools that are evidence based and effective.

Efficacy of fractionated microneedle radiofrequency with and without adding subcision for the treatment of atrophic facial acne scars: A randomized split-face clinical study.

PubMed

Faghihi, Gita; Poostiyan, Nazila; Asilian, Ali; Abtahi-Naeini, Bahareh; Shahbazi, Masoom; Iraji, Fariba; Fatemi Naeini, Farahnaz; Nilforoushzadeh, Mohammad Ali

2017-06-01

There is no gold standard treatment for facial acne scars, and overall, little literature exists about the combination therapy for treatment of acne scar. The aim of this study was to evaluate the efficacy of fractionated microneedle radiofrequency (FMR) vs FMR combined with subcision for the treatment of atrophic acne scars. This was a randomized, split-face clinical study of 25 patients with II-IV Fitzpatrick skin types with moderate to severe facial atrophic acne scars. Initially, standard subcision by Nokor needle was performed on one side. Two weeks after subcision, FMR treatment was performed on both cheeks of each participant. Second and third FMR treatment sessions were performed within 4-week intervals. Two-blinded dermatologists performed clinical assessments using a quartile grading scale, and patients were also asked to judge their satisfaction using a visual analog scale (VAS) scoring system. The age of the patients varied from 24 to 40 years (mean: 30.08±4.94 years). Only nine patients (36%) were males. Clinical assessment by two-blinded dermatologists showed statistically significant improvement in the combination (FMR+subcision) group (P=.009). Patient satisfaction was statistically significantly better in the combination group (P=.001). A darkening of skin phototype was associated with a decrease in patient's satisfaction VAS score (P=.07). The combination of subcision and FMR is a safe and effective modality for mixed type acne scars. Additional randomized clinical study with long-term follow-up is necessary for further evaluation of FMR in combination with other procedures. The full trial protocol can be accessed in: http://www.irct.ir/searchresult.php?keyword=%20%20IRCT2016103130597N1&id=30597&number=1&field=a&prt=1&total=1&m=1. The clinical trial registration number is IRCT2016103130597N1. © 2017 Wiley Periodicals, Inc.

A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization.

PubMed

Brown, Alexandra R; Gajewski, Byron J; Aaronson, Lauren S; Mudaranthakam, Dinesh Pal; Hunt, Suzanne L; Berry, Scott M; Quintana, Melanie; Pasnoor, Mamatha; Dimachkie, Mazen M; Jawdat, Omar; Herbelin, Laura; Barohn, Richard J

2016-08-31

In the last few decades, the number of trials using Bayesian methods has grown rapidly. Publications prior to 1990 included only three clinical trials that used Bayesian methods, but that number quickly jumped to 19 in the 1990s and to 99 from 2000 to 2012. While this literature provides many examples of Bayesian Adaptive Designs (BAD), none of the papers that are available walks the reader through the detailed process of conducting a BAD. This paper fills that gap by describing the BAD process used for one comparative effectiveness trial (Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations) that can be generalized for use by others. A BAD was chosen with efficiency in mind. Response-adaptive randomization allows the potential for substantially smaller sample sizes, and can provide faster conclusions about which treatment or treatments are most effective. An Internet-based electronic data capture tool, which features a randomization module, facilitated data capture across study sites and an in-house computation software program was developed to implement the response-adaptive randomization. A process for adapting randomization with minimal interruption to study sites was developed. A new randomization table can be generated quickly and can be seamlessly integrated in the data capture tool with minimal interruption to study sites. This manuscript is the first to detail the technical process used to evaluate a multisite comparative effectiveness trial using adaptive randomization. An important opportunity for the application of Bayesian trials is in comparative effectiveness trials. The specific case study presented in this paper can be used as a model for conducting future clinical trials using a combination of statistical software and a web-based application. ClinicalTrials.gov Identifier: NCT02260388 , registered on 6 October 2014.

[Modality of combined methods of quantitative and qualitative research in evaluation of therapeutic effects of Chinese medicine].

PubMed

Liu, Jian-ping

2011-05-01

The core of evidence-based medicine lies in implementing the current best available evidence of clinical research to direct the decision making in clinical practice, incorporation of individual experience and value and preference of patients. However, the current evaluation method for clinical therapeutic effect cannot reflect the humanity and wholesomeness as well as individualized tailored treatment of Chinese medicine (CM) by using randomized controlled trials. This assay addressed the complex intervention of highly individualized treatment of CM and its societal characteristics, and the author proposes a model for the evaluation of therapeutic effects of CM in which quantitative and qualitative methods are combined, embodying the characteristics of the social and natural sciences in CM. The model can show the dynamic process of CM diagnosis and treatment from a perspective of the whole system and can be used for the evaluation of complex intervention of CM. We hope to raise a different thinking and method from the new drug development in the therapeutic effect evaluation.

Systematic review on randomized controlled clinical trials of acupuncture therapy for neurovascular headache.

PubMed

Zhao, Lei; Guo, Yi; Wang, Wei; Yan, Li-juan

2011-08-01

To evaluate the effectiveness of acupuncture as a treatment for neurovascular headache and to analyze the current situation related to acupuncture treatment. PubMed database (1966-2010), EMBASE database (1986-2010), Cochrane Library (Issue 1, 2010), Chinese Biomedical Literature Database (1979-2010), China HowNet Knowledge Database (1979-2010), VIP Journals Database (1989-2010), and Wanfang database (1998-2010) were retrieved. Randomized or quasi-randomized controlled studies were included. The priority was given to high-quality randomized, controlled trials. Statistical outcome indicators were measured using RevMan 5.0.20 software. A total of 16 articles and 1 535 cases were included. Meta-analysis showed a significant difference between the acupuncture therapy and Western medicine therapy [combined RR (random efficacy model)=1.46, 95% CI (1.21, 1.75), Z=3.96, P<0.0001], indicating an obvious superior effect of the acupuncture therapy; significant difference also existed between the comprehensive acupuncture therapy and acupuncture therapy alone [combined RR (fixed efficacy model)=3.35, 95% CI (1.92, 5.82), Z=4.28, P<0.0001], indicating that acupuncture combined with other therapies, such as points injection, scalp acupuncture, auricular acupuncture, etc., were superior to the conventional body acupuncture therapy alone. The inclusion of limited clinical studies had verified the efficacy of acupuncture in the treatment of neurovascular headache. Although acupuncture or its combined therapies provides certain advantages, most clinical studies are of small sample sizes. Large sample size, randomized, controlled trials are needed in the future for more definitive results.

First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT.

PubMed

Hofmann, Reiner; Völler, Heinz; Nagels, Klaus; Bindl, Dominik; Vettorazzi, Eik; Dittmar, Ronny; Wohlgemuth, Walter; Neumann, Till; Störk, Stefan; Bruder, Oliver; Wegscheider, Karl; Nagel, Eckhard; Fleck, Eckart

2015-08-11

Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva®). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System. ClinicalTrials.gov NCT02293252 ; date of registration: 10 November 2014.

A pilot randomized controlled trial of deprescribing.

PubMed

Beer, Christopher; Loh, Poh-Kooi; Peng, Yan Gee; Potter, Kathleen; Millar, Alasdair

2011-04-01

Polypharmacy and adverse drug reactions are frequent and important among older people. Few clinical trials have evaluated systematic withdrawal of medications among older people. This small, open, study was conducted to determine the feasibility of a randomized controlled deprescribing trial. Ten volunteers living in the community (recruited by media advertising) and 25 volunteers living in residential aged-care facilities (RCFs) were randomized to intervention or control groups. The intervention was gradual withdrawal of one target medication. The primary outcome was the number of intervention participants in whom medication withdrawal could be achieved. Other outcomes measures were quality of life, medication adherence, sleep quality, and cognitive impairment. Participants were aged 80 ± 11 years and were taking 9 ± 2 medications. Fifteen participants commenced medication withdrawal and all ceased or reduced the dose of their target medication. Two subjects withdrew; one was referred for clinical review, and one participant declined further dose reductions. A randomized controlled trial of deprescribing was acceptable to participants. Recruitment in RCFs is feasible. Definitive trials of deprescribing are required.

A randomized clinical trial on the effects of remote intercessory prayer in the adverse outcomes of pregnancies.

PubMed

da Rosa, Maria Inês; Silva, Fabio Rosa; Silva, Bruno Rosa; Costa, Luciana Carvalho; Bergamo, Angela Mendes; Silva, Napoleão Chiaramonte; Medeiros, Lidia Rosi de Freitas; Battisti, Iara Denise Endruweit; Azevedo, Rafael

2013-08-01

The scope of this article was to investigate whether intercessory prayer (IP) influences the adverse outcomes of pregnancies. A double-blind, randomized clinical trial was conducted with 564 pregnant women attending a prenatal public health care service. The women were randomly assigned to an IP group or to a control group (n = 289 per group). They were simultaneously and randomly assigned to practice prayer off-site or not. The following parameters were evaluated: Apgar scores, type of delivery and birth weight. The mean age of the women was 25.1 years of age (± 7.4), and the average gestational age was 23.4 weeks (± 8.1). The average number of years of schooling for the women was 8.1 years (± 3.1). The women in the IP and control groups presented a similar number of adverse medical events with non-significant p. No significant differences were detected in the frequency of adverse outcomes in pregnant women who practiced IP and those in the control group.

Evaluation of a Sexual Assault Education/Prevention Program for Male U.S. Navy Personnel

DTIC Science & Technology

2010-01-01

MILITARY MEDICINE, 175, 6:429, 2010 Evaluation of a Sexual Assault Education/Prevention Program for Male U.S. Navy Personnel Terri J. Rau, PhD*; Lex...Mandy M. Rabenhorst, PhDf, Joel S. Milner, PhDt ABSTRACT A randomized clinical trial was conducted to evaluate the effectiveness of the Navy Sexual ...reducing rape myth acceptance, and increasing empathy for rape victims. As expected, men who had exhibited previous coercive sexual behavior, compared

Group cognitive remediation therapy for chronic schizophrenia: A randomized controlled trial.

PubMed

Tan, Shuping; Zou, Yizhuang; Wykes, Til; Reeder, Clare; Zhu, Xiaolin; Yang, Fude; Zhao, Yanli; Tan, Yunlong; Fan, Fengmei; Zhou, Dongfeng

2016-07-28

Individual-level cognitive remediation therapy (CRT) has been shown to be effective for cognitive improvement and social function amelioration. Here, we aimed to test the efficacy of group-based CRT in Chinese subjects with schizophrenia. One-hundred and four inpatients were randomly assigned to either 40 sessions of small-group CRT therapy or therapeutic contact-matched Musical and Dancing Therapy (MDT). Cognitive and social functioning, as well as clinical symptoms, were evaluated over the course of treatment. Specifically, cognitive function was evaluated using a battery of cognitive measurements, clinical symptoms were evaluated using the Positive and Negative Syndrome Scale, and social function was evaluated using the Nurse's Observation Scale for Inpatient Evaluation-30. All patients were evaluated pre- and post-treatment. Forty-four individuals in the CRT group and 46 in the MDT group completed all of the planned treatments and analyses. Cognitive functions, especially cognitive flexibility and memory, showed significant improvement in the CRT group over the course of the study. The MDT group also showed improvement in several cognitive flexibility assessments, but the degree of improvement was significantly greater in the CRT group. Several social-function factors exhibited a significant improvement in the CRT group, but not in the MDT group. Cognitive function improvement correlated positively with social function without predicting social function change. We conclude that group-based CRT is an effective and promising therapy. Copyright © 2016. Published by Elsevier Ireland Ltd.

Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mishra, Mark V., E-mail: mmishra@umm.edu; Aggarwal, Sameer; Bentzen, Soren M.

Purpose: To review and assess ongoing proton beam therapy (PBT) clinical trials and to identify major gaps. Methods and Materials: Active PBT clinical trials were identified from (clinicaltrials.gov) and the World Health Organization International Clinical Trials Platform Registry. Data on clinical trial disease site, age group, projected patient enrollment, expected start and end dates, study type, and funding source were extracted. Results: A total of 122 active PBT clinical trials were identified, with target enrollment of >42,000 patients worldwide. Ninety-six trials (79%), with a median planned sample size of 68, were classified as interventional studies. Observational studies accounted for 21% ofmore » trials but 71% (n=29,852) of planned patient enrollment. The most common PBT clinical trials focus on gastrointestinal tract tumors (21%, n=26), tumors of the central nervous system (15%, n=18), and prostate cancer (12%, n=15). Five active studies (lung, esophagus, head and neck, prostate, breast) will randomize patients between protons and photons, and 3 will randomize patients between protons and carbon ion therapy. Conclusions: The PBT clinical trial portfolio is expanding rapidly. Although the majority of ongoing studies are interventional, the majority of patients will be accrued to observational studies. Future efforts should focus on strategies to encourage optimal patient enrollment and retention, with an emphasis on randomized, controlled trials, which will require support from third-party payers. Results of ongoing PBT studies should be evaluated in terms of comparative effectiveness, as well as incremental effectiveness and value offered by PBT in comparison with conventional radiation modalities.« less

Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.

PubMed

Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

2014-04-01

This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.

Efficacy of Chinese auriculotherapy for stress in nursing staff: a randomized clinical trial

PubMed Central

Kurebayashi, Leonice Fumiko Sato; da Silva, Maria Júlia Paes

2014-01-01

Objective this randomized single blind clinical study aimed to evaluate the efficacy of auriculotherapy with and without a protocol for reducing stress levels among nursing staff. Method a total of 175 nursing professionals with medium and high scores according to Vasconcelos' Stress Symptoms List were divided into 3 groups: Control (58), Group with protocol (58), Group with no protocol (59). They were assessed at the baseline, after 12 sessions, and at the follow-up (30 days). Results in the analysis of variance, statistically significant differences between the Control and Intervention groups were found in the two evaluations (p<0.05) with greater size of effect indices (Cohen) for the No protocol group. The Yang Liver 1 and 2, Kidney, Brain Stem and Shen Men were the points most used. Conclusion individualized auriculotherapy, with no protocol, could expand the scope of the technique for stress reduction compared with auriculotherapy with a protocol. NCT: 01420835 PMID:25029046

Site Matters: Multisite Randomized Trial of Motivational Enhancement Therapy in Community Drug Abuse Clinics

PubMed Central

Ball, Samuel A.; Martino, Steve; Nich, Charla; Frankforter, Tami L.; Van Horn, Deborah; Crits-Christoph, Paul; Woody, George E.; Obert, Jeanne L.; Farentinos, Christiane; Carroll, Kathleen M.

2007-01-01

The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. There were no retention differences between the 2 brief intervention conditions. Although both 3-session interventions resulted in reductions in substance use during the 4-week therapy phase, MET resulted in sustained reductions during the subsequent 12 weeks whereas CAU was associated with significant increases in substance use over this follow-up period. This finding was complicated by program site main effects and higher level interactions. MET resulted in more sustained substance use reductions than CAU among primary alcohol users, but no difference was found for primary drug users. An independent evaluation of session audiotapes indicated that MET and CAU were highly and comparably discriminable across sites. PMID:17663610

The effect of Kinesio® taping on pain, functionality, mobility and endurance in the treatment of chronic low back pain: A randomized controlled study.

PubMed

Köroğlu, Fahri; Çolak, Tuğba Kuru; Polat, M Gülden

2017-09-22

Low back pain is one of the most important causes of morbidity. This study was designed to evaluate the effect of Kinesio® taping on pain, functionality, mobility and endurance in chronic low back pain treatment. Patients with chronic low back pain were randomly divided into three groups. Therapeutic ultrasound, hot packs, and transcutaneous electrical nerve stimulation were applied to each group for ten sessions during two weeks, and therapeutic exercises were applied in the clinic under physiotherapist supervision starting from the sixth session. Kinesio® tape was applied to the patients in the first group after each treatment session, and placebo tape was applied to the patients in the second group. No taping was applied to the third group, which constituted the control group. All the patients were evaluated pre and post-treatment in respect of pain, functional status (Oswestry scale), flexibility and endurance. The study included 60 patients (32 females). When the initial demographic and clinical characteristics of the groups were evaluated, all assessment results, except the Oswestry scores, were similar (p= 0.000). When the average changes in the clinical evaluations were evaluated after the treatment, a statistically significant improvement demonstrating the superiority of the taping group was observed in pain, functionality, flexibility and endurance values (p= 0.000, 0.000, 0.000, 0.000). Kinesio® taping in chronic low back pain is an easy and effective method which increases the effectiveness of the treatment significantly in a short period when applied in addition to exercise and electrotherapy methods.

Dermoscopy improves accuracy of primary care physicians to triage lesions suggestive of skin cancer.

PubMed

Argenziano, Giuseppe; Puig, Susana; Zalaudek, Iris; Sera, Francesco; Corona, Rosamaria; Alsina, Mercè; Barbato, Filomena; Carrera, Cristina; Ferrara, Gerardo; Guilabert, Antonio; Massi, Daniela; Moreno-Romero, Juan A; Muñoz-Santos, Carlos; Petrillo, Gianluca; Segura, Sonia; Soyer, H Peter; Zanchini, Renato; Malvehy, Josep

2006-04-20

Primary care physicians (PCPs) constitute an appropriate target for new interventions and educational campaigns designed to increase skin cancer screening and prevention. The aim of this randomized study was to determine whether the adjunct of dermoscopy to the standard clinical examination improves the accuracy of PCPs to triage lesions suggestive of skin cancer. PCPs in Barcelona, Spain, and Naples, Italy, were given a 1-day training course in skin cancer detection and dermoscopic evaluation, and were randomly assigned to the dermoscopy evaluation arm or naked-eye evaluation arm. During a 16-month period, 73 physicians evaluated 2,522 patients with skin lesions who attended their clinics and scored individual lesions as benign or suggestive of skin cancer. All patients were re-evaluated by expert dermatologists at clinics for pigmented lesions. Referral accuracy of both PCP groups was calculated by their scores, which were compared to those tabulated for dermatologists. Referral sensitivity, specificity, and positive and negative predictive values were 54.1%, 71.3%, 11.3%, and 95.8%, respectively, in the naked-eye arm, and 79.2%, 71.8%, 16.1%, and 98.1%, respectively, in the dermoscopy arm. Significant differences were found in terms of sensitivity and negative predictive value (P = .002 and P = .004, respectively). Histopathologic examination of equivocal lesions revealed 23 malignant skin tumors missed by PCPs performing naked-eye observation and only six by PCPs using dermoscopy (P = .002). The use of dermoscopy improves the ability of PCPs to triage lesions suggestive of skin cancer without increasing the number of unnecessary expert consultations.

Randomized trial of the effectiveness of combined behavioral/pharmacological smoking cessation treatment in Syrian primary care clinics.

PubMed

Ward, Kenneth D; Asfar, Taghrid; Al Ali, Radwan; Rastam, Samer; Weg, Mark W Vander; Eissenberg, Thomas; Maziak, Wasim

2013-02-01

Effectiveness of nicotine replacement therapy (NRT) for smoking cessation has not been evaluated in low income countries, such as Syria, where it is expensive and not widely available. We evaluated whether nicotine patch boosts smoking cessation rates when used in conjunction with behavioral support in primary care clinics in Aleppo, Syria. Two arm, parallel group, randomized, placebo controlled, double-blinded multi-site trial. Four primary care clinics in Aleppo, Syria.  Two hundred and sixty-nine adult primary care patients received behavioral cessation counseling from a trained primary care physician and were randomized to receive six weeks of treatment with nicotine versus placebo patch. Primary end-points were prolonged abstinence (no smoking after a 2-week grace period) at end of treatment, and 6 and 12 months post-quit day, assessed by self-report and exhaled carbon monoxide levels of <10 p.p.m. Treatment adherence was excellent and nicotine patch produced expected reductions in urges to smoke and withdrawal symptoms, but no treatment effect was observed. The proportion of patients in the nicotine and placebo groups with prolonged abstinence was 21.6% and 20.0%, respectively, at end of treatment, 13.4% and 14.1% at 6 months, and 12.7% and 11.9% at 12 months.  Nicotine patches may not be effective in helping smokers in low-income countries to stop when given as an adjunct to behavioural support. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

Efficacy of fermented green tea on peripheral skin temperature: a randomized and placebo-controlled clinical study.

PubMed

Lee, Eunyoung; Lee, Bum-Jin; Ha, Jaehyoun; Shin, Hyun-Jung; Chung, Jin-Oh

2016-09-01

This study was aimed at assessing the therapeutic efficacy of green tea on peripheral skin for cold hypersensitive subjects, who had the feeling of cold hands and feet at cold temperatures, one of the most common complaints in Asian women. This randomized and placebo-controlled clinical study included 60 female Korean subjects who had the feeling of cold hands and feet at cold temperatures. The subjects were randomly assigned into two groups to receive fermented green tea or a placebo (hot water). The skin temperature of the hands and feet was measured using digital infrared thermography at the baseline and at 15, 30, 45, and 60 min after the oral administration of the tea or placebo. The skin temperature of the hands and feet of the fermented green tea-administered group was significantly higher than that of the placebo-administered group. The temperature difference between the finger and the dorsum of the hand was significantly lower in the fermented green tea-administered group than that in the placebo group. Fermented green tea is helpful for cold hypersensitivity. This is the first clinical study to evaluate the efficacy of fermented green tea on peripheral skin in subjects having the feeling of cold hands and feet at cold temperatures by infrared thermography. However, further studies are necessary to evaluate the long-term effects of the fermented green tea for cold hypersensitivity and to elucidate the underlying physiological mechanism. © 2015 Wiley Periodicals, Inc.

Clinical comparison between open plating and minimally invasive plate osteosynthesis for displaced proximal humeral fractures: A prospective randomized controlled trial.

PubMed

Sohn, Hoon-Sang; Jeon, Yoon Sang; Lee, JuHan; Shin, Sang-Jin

2017-06-01

Recently, minimally invasive plate osteosynthesis (MIPO) has been widely used for the treatment of proximal humeral fractures. However, there is concern about whether the MIPO in comminuted proximal humeral fractures is also comparable to open plating. The purpose of this study was to compare the clinical and radiographic outcomes of open plating and MIPO for acute displaced proximal humeral fractures. In this prospective, randomized controlled study, 107 patients who had an acute proximal humeral fracture were randomized to either the open plating or MIPO techniques. Forty-five patients treated with open plating and 45 with the MIPO technique who were followed up at least 1year were evaluated. Shoulder functional assessment, operating time, several radiographic parameters, and complications were evaluated at final follow-up. The mean follow-up period was 15.0 months in the open plating and 14.3 months in the MIPO technique. There were no statistically significant differences in functional assessment scores and radiographic parameters between the two groups. High complications rates were found in 4-part fracture in both surgical methods The average operation time in the MIPO group were significantly lower compared to the open plating group (p<0.05). This study showed MIPO in proximal humerus fractures had similar clinical and radiographic outcomes compared to the open plating. However, the MIPO technique in proximal humerus fracture provided significantly shorter operation time than the open plating. Copyright © 2017 Elsevier Ltd. All rights reserved.

Treatment of Non-neurogenic Overactive Bladder with OnabotulinumtoxinA: Systematic Review and Meta-analysis of Prospective, Randomized, Placebo-controlled Clinical Trials.

PubMed

Arruda, Raquel Martins; Takano, Claudia Cristina; Girão, Manoel João Batista Castelo; Haddad, Jorge Milhem; Aleixo, Gabriel Francisco; Castro, Rodrigo Aquino

2018-04-01

We performed a systematic review and meta-analysis of randomized placebo-controlled trials that studied non-neurogenic overactive bladder patients who were treated with 100 units of onabotulinumtoxinA or placebo. The primary purpose of our study was to evaluate the clinical effectiveness with regard to urinary urgency, urinary frequency, nocturia, and incontinence episodes. Our secondary purpose consisted of evaluating the adverse effects. Our initial search yielded 532 entries. Of these, seven studies met all the inclusion criteria (prospective, randomized, placebo-controlled studies, ≥ 3 points on the Jadad scale) and were selected for analysis. For all primary endpoints, the toxin was more effective than placebo ( p  < 0.0001; 95% confidence interval [95CI]), namely: urgency (mean difference = -2.07; 95CI = [-2.55-1.58]), voiding frequency (mean difference = -1.64; 95CI = [-2.10-1.18]), nocturia (mean difference = -0.25; 95CI = [-0.39-0.11]) and incontinence episodes (mean difference = -2.06; 95CI= [-2.60-1.52]). The need for intermittent catheterization and the occurrence of urinary tract infection (UTI) were more frequent in patients treated with onabotulinumtoxinA than in patients treated with placebo ( p  < 0.0001). Compared with placebo, onabotulinumtoxinA had significantly and clinically relevant reductions in overactive bladder symptoms and is associated with higher incidence of intermittent catheterization and UTI. Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil.

Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial.

PubMed

Narita, Zui; Yokoi, Yuma

2017-06-19

Patients with Alzheimer's disease frequently elicit neuropsychiatric symptoms as well as cognitive deficits. Above all, depression is one of the most common neuropsychiatric symptoms in Alzheimer's disease but antidepressant drugs have not shown significant beneficial effects on it. Moreover, electroconvulsive therapy has not ensured its safety for potential severe adverse events although it does show beneficial clinical effect. Transcranial direct current stimulation can be the safe alternative of neuromodulation, which applies weak direct electrical current to the brain. Although transcranial direct current stimulation has plausible evidence for its effect on depression in young adult patients, no study has explored it in older subjects with depression in Alzheimer's disease. Therefore, we present a study protocol designed to evaluate the safety and clinical effect of transcranial direct current stimulation on depression in Alzheimer's disease in subjects aged over 65 years. This is a two-arm, parallel-design, randomized controlled trial, in which patients and assessors will be blinded. Subjects will be randomized to either an active or a sham transcranial direct current stimulation group. Participants in both groups will be evaluated at baseline, immediately, and 2 weeks after the intervention. This study investigates the safety and effect of transcranial direct current stimulation that may bring a significant impact on both depression and cognition in patients with Alzheimer's disease, and may be useful to enhance their quality of life. ClinicalTrials.gov, NCT02351388 . Registered on 27 January 2015. Last updated on 30 May 2016.

The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease. Methods/Design The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial. Discussion The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage. Trial registration Trial registration reference: ISRCTN45433299 PMID:23356861

Cost-saving treatment strategies in in vitro fertilization: a combined economic evaluation of two large randomized clinical trials comparing highly purified human menopausal gonadotropin and recombinant follicle-stimulating hormone alpha.

PubMed

Wechowski, Jaroslaw; Connolly, Mark; Schneider, Dirk; McEwan, Philip; Kennedy, Richard

2009-04-01

To assess the cost-effectiveness of two gonadotropin treatments that are available in the United Kingdom in light of limited public funding and the fundamental role of costs in IVF treatment decisions. An economic evaluation based on two large randomized clinical trials in IVF patients using a simulation model. Fifty-three fertility clinics in 13 European countries and Israel. Women indicated for treatment with IVF (N = 986), aged 18-38, participating in double-blind, randomized controlled trials. Highly purified menotropin (HP-hMG, Menopur) or recombinant follitropin alpha (rFSH, Gonal-F). Cost per IVF cycle and cost per live birth for HP-hMG and rFSH alpha. HP-hMG was more effective and less costly versus rFSH for both IVF cost per live birth and for IVF cost per baby (incremental cost-effectiveness ratio was negative). The mean costs per IVF treatment for HP-hMG and rFSH were 2408 pounds (95% confidence interval [CI], 2392 pounds, 2421 pounds) and 2660 pounds (95% CI 2644 pounds, 2678 pounds), respectively. The mean cost saving of 253 pounds per cycle using HP-hMG allows one additional cycle to be delivered for every 9.5 cycles. Treatment with HP-hMG was dominant compared with rFSH in the United Kingdom. Gonadotropin costs should be considered alongside live-birth rates to optimize outcomes using scarce health-care resources.

A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections.

PubMed

O'Riordan, William; Mehra, Purvi; Manos, Paul; Kingsley, Jeff; Lawrence, Laura; Cammarata, Sue

2015-01-01

A randomized, double-blind, multicenter trial was done to compare two doses of delafloxacin with tigecycline in patients with various complicated skin and skin-structure infections (wound infections following surgery, trauma, burns, or animal/insect bites, abscesses, and cellulitis). Patients were randomized 1:1:1 to receive delafloxacin 300mg intravenous (IV) every 12h, delafloxacin 450mg IV every 12h, or tigecycline 100mg IV×1, followed by 50mg IV every 12h; randomization was stratified by infection type. Duration of therapy was 5-14 days. The primary efficacy analysis, performed on the clinically evaluable (CE) population at the test-of-cure (TOC) visit (14-21 days after the final dose of study drug), compared clinical response rates in the delafloxacin and tigecycline arms. Clinical response rates in the two delafloxacin arms were also compared. Among CE patients, clinical cure rates at TOC visit were similar in the delafloxacin and tigecycline arms (94.3%, 92.5%, and 91.2%, respectively in delafloxacin 300-mg, delafloxacin 450-mg, and tigecycline arms). Overall, the most frequent adverse events were nausea, vomiting, and diarrhea; the 300-mg delafloxacin arm was the best-tolerated regimen. Delafloxacin was similarly effective as tigecycline for a variety of complicated skin and skin-structure infections and was well tolerated. (Clinicaltrials.gov NCT 0719810). Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

DEVELOPING AN IPAD® APPLICATION FOR DATA COLLECTION IN A RHEUMATOLOGY RESEARCH CLINIC.

PubMed

Kaka, Hussam; Ayearst, Renise; Tran, Maithy; Touma, Zahi; Bagovich, Maria; Vinik, Ophir; Somaily, Mansour; Haddad, Amir; Gladman, Dafna D; Chandran, Vinod

2015-01-01

Clinical research data are often collected on paper and later inputted onto an electronic database. This method is time consuming and potentially introduces errors. Therefore, to make primary data collection more efficient and less error prone we aimed to develop a touch-screen application for data collection in a psoriatic arthritis research clinic and compared it with the pre-existing paper-based system. We developed a Web application using Java and optimized it for the iPad®. It highlights missing fields for physicians in real time, and only permits submission of data collection form after corrections are made. For its evaluation, seven physicians participated, and before each patient visit they were randomly assigned paper or iPad® data entry. Number of errors, length of visit, and time between clinic visit and completion of data entry were measured. A total of 106 patients seen in the clinic who agreed to participate were randomly assigned to be evaluated by clinic physicians using the iPad® (fifty-three patients) or a paper protocol (fifty-three patients). On average, 3.34 omissions were found per paper form, of which 2.24 would have been detected on the iPad®. The iPad® increased the mean patient encounter time from 37.2 minutes to 46.5 minutes, but eliminated delay between a clinic visit and its data entry. Entering data using the iPad® application makes the patient encounter slightly longer, but reduces "missing fields." It also eliminates the delay between clinic visit and data entry thus improving the efficiency of clinical data capture in a research setting.

Effectiveness of pre-treatment with chlorhexidine in restoration retention: A 36-month follow-up randomized clinical trial.

PubMed

Favetti, Morgana; Schroeder, Thaiane; Montagner, Anelise Fernandes; Correa, Marcos Britto; Pereira-Cenci, Tatiana; Cenci, Maximiliano Sergio

2017-05-01

This study evaluated the effect of the pre-treatment with 2% chlorhexidine digluconate (CHX) as coadjutant in restoration retention of noncarious cervical lesions (NCCL), after 36 months of follow-up. A randomized controlled split-mouth and triple-blind (operators, patients and evaluator) trial was carried out. Patients (n=42) with at least two non-carious cervical lesions were included. The teeth with NCCL were randomly assigned to two treatment groups: application of 2% CHX (experimental group) or a placebo solution (control group) for 60s after acid etching and before the adhesive application. A trained and calibrated examiner evaluated the restorations at baseline (1 week) and at each recall (6, 12, 24 and 36 months) using the FDI criteria. A total of 225 restorations were evaluated after 36-month follow-up. Data were subjected to survival analysis using the Kaplan-Meier method, and the log-rank test was used to evaluate the existence of differences between the survival curves (α=0.05). The restorations survival rate after 36 months of follow-up was 76.1%. There was no difference in the retention and failure rates between the experimental and the control group (p=0.968). There was an increased failure trend when restorations were located subgingival compared to those at the gingival level or supragingival. The pre-treatment with 2% chlorhexidine digluconate did not promote further restoration retention of noncarious cervical lesions. The cavity pre-treatment with chlorhexidine for inhibition of hybrid layer degradation does not add any beneficial effect to the clinical performance of restorations. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial].

PubMed

Schneider, Franciane; Danski, Mitzy Tannia Reichembach; Vayego, Stela Adami

2015-04-01

To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27) and experimental (24). There is statistically significant evidence (p-value = 0.0120) that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402). Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

Clinical and radiographic evaluation of one- and two-visit endodontic treatment of asymptomatic necrotic teeth with apical periodontitis: a randomized clinical trial.

PubMed

Molander, Anders; Warfvinge, Johan; Reit, Claes; Kvist, Thomas

2007-10-01

The present investigation recorded the 2-year clinical and radiographic outcome of one- and two visit endodontic treatment and studied the significance of the bacteriologic sampling results on the outcome. A randomization procedure allocated 53 teeth to one-visit treatment and 48 teeth to two-visit treatment. At the end of the study period, 32 teeth (65%) in the one-visit group and 30 teeth (75%) in the two-visit group were classified as healed. The statistical analysis of the healing results did not show any significant difference between the groups (p = 0.75). Forty-nine (80%) of the 61 teeth that were obturated after a negative micobiologic sample were classified as healed. Teeth sealed after positive samples healed in 44%. The present study gave evidence that similar healing results might be obtained through one- and two-visit antimicrobial treatment.

Strategies for dealing with missing data in clinical trials: from design to analysis.

PubMed

Dziura, James D; Post, Lori A; Zhao, Qing; Fu, Zhixuan; Peduzzi, Peter

2013-09-01

Randomized clinical trials are the gold standard for evaluating interventions as randomized assignment equalizes known and unknown characteristics between intervention groups. However, when participants miss visits, the ability to conduct an intent-to-treat analysis and draw conclusions about a causal link is compromised. As guidance to those performing clinical trials, this review is a non-technical overview of the consequences of missing data and a prescription for its treatment beyond the typical analytic approaches to the entire research process. Examples of bias from incorrect analysis with missing data and discussion of the advantages/disadvantages of analytic methods are given. As no single analysis is definitive when missing data occurs, strategies for its prevention throughout the course of a trial are presented. We aim to convey an appreciation for how missing data influences results and an understanding of the need for careful consideration of missing data during the design, planning, conduct, and analytic stages.

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

PubMed

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

2008-01-01

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

A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs.

PubMed

Mauri, Laura; Kario, Kazuomi; Basile, Jan; Daemen, Joost; Davies, Justin; Kirtane, Ajay J; Mahfoud, Felix; Schmieder, Roland E; Weber, Michael; Nanto, Shinsuke; Azizi, Michel

2018-01-01

Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies. Accordingly, the RADIANCE-HTN and REQUIRE studies are multicenter, blinded, randomized, sham-controlled trials designed to assess the blood pressure-lowering efficacy of the ultrasound-based renal denervation system (Paradise) in patients with established hypertension either on or off antihypertensive medications, is designed to evaluate patients in 2 cohorts-SOLO and TRIO, in the United States and Europe. The SOLO cohort includes patients with essential hypertension, at low cardiovascular risk, and either controlled on 1 to 2 antihypertensive medications or uncontrolled on 0 to 2 antihypertensive medications. Patients undergo a 4-week medication washout period before randomization to renal denervation (treatment) or renal angiogram (sham). The TRIO cohort includes patients with hypertension resistant to at least 3 antihypertensive drugs including a diuretic. Patients will be stabilized on a single-pill, triple-antihypertensive-drug combination for 4weeks before randomization to treatment or sham. Reduction in daytime ambulatory systolic blood pressure (primary end point) will be assessed at 2months in both cohorts. A predefined medication escalation protocol, as needed for blood pressure control, is implemented between 2 and 6months in both cohorts by a study staff member blinded to the randomization process. At 6months, daytime ambulatory blood pressure and antihypertensive treatment score will be assessed. REQUIRE is designed to evaluate patients with resistant hypertension on standard of care medication in Japan and Korea. Reduction in 24-hour ambulatory systolic blood pressure will be assessed at 3months (primary end point). Both studies are enrolling patients, and their results are expected in 2018. Copyright © 2017 Elsevier Inc. All rights reserved.

A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis.

PubMed

Parish, Lawrence Charles; Parish, Jennifer L; Routh, Hirak B; Fleischer, Alan B; Avakian, Edward V; Plaum, Stefan; Hardas, Bhushan

2011-11-01

Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States. This randomized, double-blind, vehicle-controlled, phase 3 trial evaluated the efficacy and safety of two weeks of NAFT-2 treatment in subjects with tinea pedis. Naftifine 1% cream (NAFT-1) treatment for four weeks and vehicle were also evaluated as a positive control. 709 subjects were randomly assigned 2:1:2:1 to one of four treatment groups: (i) NAFT-2 (n= 235), (ii) two-week vehicle (n=118), (iii) NAFT-1 (n=237), or (iv) four-week vehicle (n=119). Efficacy was evaluated at baseline, week 2, week 4, and week 6 and consisted of mycology determination (KOH and dermatophyte culture) and scoring of clinical symptom severity (erythema, scaling, and pruritus). Efficacy was only analyzed in 425 subjects with positive baseline dermatophyte culture. Safety was evaluated by adverse events (AE) and laboratory values in 707 subjects. At week 6, NAFT-2 subjects achieved 18 percent complete cure rate, 67 percent mycological cure rate, 57 percent treatment effectiveness, 22 percent clinical cure rate, and 78 percent clinical success rate compared to respective vehicle rates of seven percent (one-sided, P<0.01), 21 percent (P<0.001), 20 percent (P<0.001), 11 percent (P=0.04) and 49 percent (P<0.001). Week 6 efficacy responses in NAFT-1-treated subjects were significantly higher than vehicle subjects and almost identical to NAFT-2 subjects. Mycological cure and clinical response rates in both NAFT-2 and NAFT-1 increased from week 2 to week 6. Treatment-related AEs occurred in five percent of NAFT-2 subjects, seven percent of vehicle subjects, four percent of NAFT-1 subjects and eight percent of vehicle subjects. The most common AEs for all groups were application site pruritus and skin irritation. Topical NAFT-2 for two weeks is safe and provides significantly superior antifungal treatment than vehicle in tinea pedis subjects. NAFT-2 produces equivalent efficacy responses to four weeks of NAFT-1 treatment. The fungicidal activity of naftifine continues to increase for at least one month after treatment is completed. (Clinical Trials Identification Numbe=NCT00750139). J Drugs Dermatol. 2011;10(11):1282-1288.

Sun Protection by Beach Umbrella vs Sunscreen With a High Sun Protection Factor: A Randomized Clinical Trial.

PubMed

Ou-Yang, Hao; Jiang, Lily I; Meyer, Karen; Wang, Steve Q; Farberg, Aaron S; Rigel, Darrell S

2017-03-01

Sun-protective behavior affects skin cancer prevention. Shade works by physically shielding skin from direct harmful UV rays; however, skin may still remain exposed to reflected and indirect UV rays. There is no current standard metric to evaluate shade for its effectiveness in sun protection, and there is insufficient clinical evidence that a beach umbrella alone can provide adequate sun protection. To directly measure sunburn protection offered by a standard beach umbrella compared with that provided by sunscreen with a high sun protection factor under actual use conditions. A single-center, evaluator-blinded, randomized clinical study was conducted from August 13 to 15, 2014, in Lake Lewisville, Texas (elevation, 159 m above sea level), among 81 participants with Fitzpatrick skin types I (n = 1), II (n = 42), and III (n = 38). Participants were randomly assigned to 2 groups: 1 using only a beach umbrella, and the other using only sunscreen with a sun protection factor of 100. All participants remained at a sunny beach for 3½ hours at midday. Clinical sunburn evaluation of each individual for all exposed body sites was conducted 22 to 24 hours after sun exposure. The shade provided by a beach umbrella or protection provided by sunscreen with a sun protection factor of 100. Sunburn on all exposed body sites 22 to 24 hours after sun exposure. Among the 81 participants (25 male and 56 female; mean [SD] age, 41 [16] years) for all body sites evaluated (face, back of neck, upper chest, arms, and legs), the umbrella group showed a statistically significant increase in clinical sunburn scores compared with baseline and had higher postexposure global scores than the sunscreen group (0.75 vs 0.05; P < .001). There was a total of 142 sunburn incidences in the umbrella group vs 17 in the sunscreen group. Thirty-two of the 41 participants (78%) in the umbrella group showed erythema in 1 or more sites vs 10 of the 40 participants (25%) in the sunscreen group (P < .001). Neither umbrella nor sunscreen alone completely prevented sunburn. A beach umbrella alone may not provide sufficient protection for extended UV exposure. It is important to educate the public that combining multiple sun protection measures may be needed to achieve optimal protection. isrctn.org Identifier: ISRCTN19177299.

Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication use.

PubMed

Shrank, William H; Parker, Ruth; Davis, Terry; Pandit, Anjali U; Knox, Joann P; Moraras, Pear; Rademaker, Alfred; Wolf, Michael S

2010-11-01

Medication errors are an important public health concern, and poor understanding of medication labels are a root cause. Research shows that labels are variable, of poor quality, and not patient-centered. No real-world trials have evaluated whether improved medication labels can affect appropriate medication use, adherence or health outcomes. We developed an evidence-based prescription label that addresses both content and format. The enhanced label includes a universal medication schedule (UMS) that standardizes the directions for use incorporating 1) standard time periods for administration (morning, noon, evening, and bedtime), 2) numeric vs. alpha characters, 3) 'carriage returns' to separate daily dose and 4) a graphic aid to visually depict dose and frequency. We will evaluate the effect of providing this label to randomly sampled patients who receive their care from free clinics, mobile vans and federally qualified health centers (FQHCs) in Northern Virginia. We will recruit patients with diabetes or hypertension; these patients will be randomly assigned to receive all of their medications with improved labels or to receive prescriptions with standard labels. The primary outcome will be the patient's ability to correctly demonstrate dosing instructions. Other outcomes include adherence, error rates and health outcomes. To our knowledge, this trial is the first to evaluate the effect of prescription label improvement on understanding, medication use and outcomes in a clinical setting. If successful, these findings could be implemented broadly to promote safe and appropriate medication use and to support evidence-based standards in the development of labels. Copyright © 2010 Elsevier Inc. All rights reserved.

Rationale and design of the Post-MI FREEE trial: A randomized evaluation of first-dollar drug coverage for post–myocardial infarction secondary preventive therapies

PubMed Central

Choudhry, Niteesh K.; Brennan, Troyen; Toscano, Michele; Spettell, Claire; Glynn, Robert J.; Rubino, Mark; Schneeweiss, Sebastian; Brookhart, Alan M.; Fernandes, Joaquim; Mathew, Susan; Christiansen, Blake; Antman, Elliott M.; Avorn, Jerry; Shrank, William H.

2009-01-01

Background Medication nonadherence is a major public health problem, especially for patients with coronary artery disease. The cost of prescription drugs is a central reason for nonadherence, even for patients with drug insurance. Removing patient out-of-pocket drug costs may increase adherence, improve clinical outcomes, and even reduce overall health costs for high-risk patients. The existing data are inadequate to assess whether this strategy is effective. Trial Design The Post-Myocardial Infarction Free Rx and Economic Evaluation (Post-MI FREEE) trial aims to evaluate the effect of providing full prescription drug coverage (ie, no copays, coinsurance, or deductibles) for statins, β-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers to patients after being recently discharged from the hospital. Potentially eligible patients will be those individuals who receive their health and pharmacy benefits through Aetna, Inc. Patients enrolled in a Health Savings Account plan, who are ≥65 years of age, whose plan sponsor (ie, the employer, union, government, or association that sponsors the particular benefits package) has opted out of participating in the study, and who do not receive both medical services and pharmacy coverage through Aetna will be excluded. The plan sponsor of each eligible patient will be block randomized to either full drug coverage or current levels of pharmacy benefit, and all subsequently eligible patients of that same plan sponsor will be assigned to the same benefits group. The primary outcome of the trial is a composite clinical outcome of readmission for acute MI, unstable angina, stroke, congestive heart failure, revascularization, or inhospital cardiovascular death. Secondary outcomes include medication adherence and health care costs. All patients will be followed up for a minimum of 1 year. Conclusion The Post-MI FREEE trial will be the first randomized study to evaluate the impact of reducing cost-sharing for essential cardiac medications in high-risk patients on clinical and economic outcomes. PMID:18585494

Effects of dental magnification lenses on indirect vision: a pilot study.

PubMed

Hoerler, Sarah B; Branson, Bonnie G; High, Anne M; Mitchell, Tanya Villalpando

2012-01-01

The purpose of this pilot study was to evaluate the effect of magnification lenses on the indirect vision skills of dental hygiene students. This pilot study examined the accuracy and efficiency of dental hygiene students' indirect vision skills while using traditional safety lenses and magnification lenses. The sample was comprised of 14 students in their final semester of a dental hygiene program. A crossover study approach was utilized, with each participant randomly assigned to a specific order of eyewear. The study included evaluation of each participant taking part in 2 separate clinical sessions. During the first session, each participant completed a clinical exercise on a dental manikin marked with 15 dots throughout the oral cavity while wearing the randomly as signed eyewear, and then completed a similar exercise on a differently marked dental manikin while wearing the randomly assigned eyewear. This procedure was repeated at a second clinical session, however, the dental manikin and eyewear pairings were reversed. Accuracy was measured on the number of correctly identified dots and efficiency was measured by the time it took to identify the dots. Perceptions of the participants' use of magnification lenses and the participants' opinion of the use of magnification lenses in a dental hygiene curriculum were evaluated using a questionnaire. Comparing the mean of the efficiency scores, students are more efficient at identifying indirect vision points with the use of magnification lenses (3 minutes, 36 seconds) than with traditional safety lenses (3 minutes, 56 seconds). Comparing the measurement of accuracy, students are more accurate at identifying indirect vision points with traditional safety lenses (84%) as com pared to magnification lenses (79%). Overall, the students report ed an increased quality of dental hygiene treatment provided in the clinical setting and an improved clinical posture while treating patients with the use of magnification lenses. This study did not produce statistically significant data to support the use of magnification lenses to enhance indirect vision skills among dental hygiene students, however, students perceived that their indirect vision skills were enhanced by the use of magnification lenses.

A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris.

PubMed

Parish, Lawrence Charles; Parish, Jennifer L; Routh, Hirak B; Avakian, Edward; Olayinka, Babajide; Pappert, Eric J; Plaum, Stefan; Fleischer, Alan B; Hardas, Bhushan

2011-10-01

Naftifine HCl 2% cream (NAFT-2%) is a topical allylamine antifungal preparation under development in the U.S. The objective of this randomized, double-blind, vehicle-controlled study was to evaluate the efficacy and safety of a two-week course of once-daily NAFT-2% vs. vehicle in the treatment of Tinea cruris ("jock itch"). A total of 334 subjects with T. cruris were enrolled and randomly assigned to NAFT-2% (n=166) or vehicle (n=168), which was applied once daily for 14 days. Efficacy and safety were evaluated at week 2 (end of treatment) and week 4. Efficacy measures included complete cure, treatment effectiveness, mycological cure, clinical cure, and clinical success and were analyzed only in subjects with a positive potassium hydroxide (KOH) and dermatophyte culture at baseline (n=75, naftifine; n=71, vehicle). Safety was assessed by adverse events and changes from baseline in clinical status and laboratory studies. At week 4, 25 percent of naftifine-treated subjects achieved complete cure vs. three percent of vehicle subjects and 72 percent achieved mycological cure vs. 16 percent of vehicle treated subjects (one-sided, P<0.001). Treatment effectiveness was achieved in 60 percent of NAFT-2% subjects vs. 10 percent of vehicle subjects (one-sided, P<0.001). Clinical cure rate and clinical success rate were 33 percent and 84 percent in NAFT-2% subjects, respectively vs. 10 percent and 46 percent in vehicle subjects (both P is less than 0.001, 2-sided). Week 2 efficacy response rates in NAFT-2% subjects were all lower than at week 4 but were significantly higher than week 2 vehicle-treated counterparts (P<0.025). Treatment-related AE occurred in 11 subjects (7 NAFT-2%, 4 vehicle) during the study. The most common AE in both groups were contact dermatitis (2 NAFT-2%), pruritus (2 vehicle), and application site reaction (1 per group). NAFT-2% applied once daily for two weeks (one-half the treatment duration for naftifine 1% cream) is efficacious and safe for the treatment of T. cruris.

Comparison of Effectiveness of Supervised Exercise Program and Cyriax Physiotherapy in Patients with Tennis Elbow (Lateral Epicondylitis): A Randomized Clinical Trial

PubMed Central

Viswas, Rajadurai; Ramachandran, Rejeeshkumar; Korde Anantkumar, Payal

2012-01-01

Objective. To compare the effectiveness of supervised exercise program and Cyriax physiotherapy in the treatment of tennis elbow (lateral epicondylitis). Design. Randomized clinical trial. Setting. Physiotherapy and rehabilitation centre. Subjects. This study was carried out with 20 patients, who had tennis elbow (lateral epicondylitis). Intervention. Group A (n = 10) had received supervised exercise program. Group B (n = 10) was treated with Cyriax physiotherapy. All patients received three treatment sessions per week for four weeks (12 treatment sessions). Outcome measures. Pain was evaluated using a visual analogue scale (VAS), and functional status was evaluated by completion of the Tennis Elbow Function Scale (TEFS) which were recorded at base line and at the end of fourth week. Results. Both the supervised exercise program and Cyriax physiotherapy were found to be significantly effective in reduction of pain and in the improvement of functional status. The supervised exercise programme resulted in greater improvement in comparison to those who received Cyriax physiotherapy. Conclusion. The results of this clinical trial demonstrate that the supervised exercise program may be the first treatment choice for therapist in managing tennis elbow. PMID:22629225

Comparison between two surgical techniques for root coverage with an acellular dermal matrix graft.

PubMed

Andrade, Patrícia F; Felipe, Maria Emília M C; Novaes, Arthur B; Souza, Sérgio L S; Taba, Mário; Palioto, Daniela B; Grisi, Márcio F M

2008-03-01

The aim of this randomized, controlled, clinical study was to compare two surgical techniques with the acellular dermal matrix graft (ADMG) to evaluate which technique could provide better root coverage. Fifteen patients with bilateral Miller Class I gingival recession areas were selected. In each patient, one recession area was randomly assigned to the control group, while the contra-lateral recession area was assigned to the test group. The ADMG was used in both groups. The control group was treated with a broader flap and vertical-releasing incisions, and the test group was treated with the proposed surgical technique, without releasing incisions. The clinical parameters evaluated before the surgeries and after 12 months were: gingival recession height, probing depth, relative clinical attachment level and the width and thickness of keratinized tissue. There were no statistically significant differences between the groups for all parameters at baseline. After 12 months, there was a statistically significant reduction in recession height in both groups, and there was no statistically significant difference between the techniques with regard to root coverage. Both surgical techniques provided significant reduction in gingival recession height after 12 months, and similar results in relation to root coverage.

Influence of clinical baseline findings on the survival of 2 post systems: a randomized clinical trial.

PubMed

Schmitter, Marc; Rammelsberg, Peter; Gabbert, Olaf; Ohlmann, Brigitte

2007-01-01

The aim of this prospective randomized controlled trial was to evaluate the influence of clinical baseline characteristics on the survival of 2 post systems. One hundred patients needing a post were included. Half the patients received a glass fiber-reinforced post (FRP), and the other half received metal screw posts (MSP). The posts were assigned randomly. In addition to demographic data, the following parameters were recorded: type of tooth (incisor/canine versus molar/premolar), length of the post in relation to root length (percentage), extent of coronal tooth destruction (percentage), ferrule height (in millimeters), type of restoration (fixed or removable partial denture), and presence of antagonistic contacts (yes/no). After at least 1 year (mean: 13.84 months), the patients were recalled. Statistical analysis was performed using the log-rank test and Cox regression analysis. The survival rate of FRPs was 93.5%. In the MSP group, the survival rate was significantly lower (75.6%; log-rank test, P = .049). Additionally, the metal posts were associated with more unfavorable complications, for example, root fracture. The type of the tooth and the degree of coronal tooth destruction influenced the survival of MSPs, whereas no influence of these variables could be seen for FRPs. FRPs are superior to MSPs with respect to short-term clinical performance. Especially for MSPs, clinical survival depends on several variables.

A randomized controlled trial evaluating the effect of ethinyl estradiol during clomiphene citrate cycles among women with polycystic ovary syndrome.

PubMed

Moini, Ashraf; Ahmadi, Firoozeh; Jahangiri, Nadia; Ahmadi, Jila; Akhoond, Mohammad Reza

2015-11-01

To investigate the effects of low-dose ethinyl estradiol (EE) on the clinical pregnancy rate among women with polycystic ovary syndrome (PCOS) undergoing ovulation induction with clomiphene citrate (CC). Between March 12, 2011, and February 10, 2013, a randomized, double-blind, placebo-controlled trial was conducted at the Royan Institute Research Center, Tehran, Iran, among women with PCOS who were aged 25-30 years, were undergoing their first intrauterine insemination cycle, and had a history (≥2 years) of infertility, oligomenorrhea, or amenorrhea. Participants were randomly allocated to receive EE (0.05 mg daily for 5 days) or placebo, co-administered with CC cycles (100 mg daily for 5 days). The primary outcome was clinical pregnancy rate. Analyses were per protocol: patients who discontinued the intervention were excluded. Analyses included 45 women who received CC and EE, and 50 women who received CC and placebo. The number of women who achieved a clinical pregnancy was higher among participants who received CC and EE (13 [29%]) than among those in the control group (5 [10%]; P =0 .02). No adverse effects of EE were reported. The combination of CC and EE seems to increase the clinical pregnancy rate among women with PCOS undergoing intrauterine insemination. ClinicalTrials.gov:NCT01219101. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial

PubMed Central

Rocca, Corinne H.; Kohn, Julia E.; Goodman, Suzan; Stern, Lisa; Blum, Maya; Speidel, J. Joseph; Darney, Philip D.; Harper, Cynthia C.

2016-01-01

Objectives. We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. Methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011–2013). Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500: 802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Results. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR = 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Conclusions. Public funding and provider training substantially improve LARC access. PMID:26794168

Features Associated with Successful Recruitment of Diverse Patients onto Cancer Clinical Trials: Report from the American College of Surgeons Oncology Group

PubMed Central

Diehl, Kathleen M.; Green, Erin M.; Weinberg, Armin; Frederick, Wayne A.; Holmes, Dennis R.; Green, Bettye; Morris, Arden; Kuerer, Henry M.; Beltran, Robert A.; Mendez, Jane; Gines, Venus; Ota, David M.; Nelson, Heidi; Newman, Lisa A.

2018-01-01

Background The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. Study Design We evaluated the accrual patterns for ten clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999–2009, and analyzed results by race/ethnicity as well as study design. Results Eight of ten protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully-recruiting protocols were: (i) studies designed to recruit patients with regional or advanced-stage disease (2/2 protocols); and (ii) studies that involved some investigational systemic therapy (3/3 protocols). Discussion AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients. PMID:21681382

A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention).

PubMed

Bandak, Mikkel; Jørgensen, Niels; Juul, Anders; Lauritsen, Jakob; Kreiberg, Michael; Oturai, Peter Sandor; Helge, Jørn Wulff; Daugaard, Gedske

2017-07-03

Elevated serum levels of luteinizing hormone and slightly decreased serum levels of testosterone (mild Leydig cell insufficiency) is a common hormonal disturbance in testicular cancer (TC) survivors. A number of studies have shown that low serum levels of testosterone is associated with low grade inflammation and increased risk of metabolic syndrome. However, so far, no studies have evaluated whether testosterone substitution improves metabolic dysfunction in TC survivors with mild Leydig cell insufficiency. This is a single-center, randomized, double-blind, placebo-controlled study, designed to evaluate the effect of testosterone replacement therapy in TC survivors with mild Leydig cell insufficiency. Seventy subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent will be obtained. Afterwards, a 52-weeks treatment period begins in which study participants will receive a daily dose of transdermal testosterone or placebo. Dose adjustment will be made three times during the initial 8 weeks of the study to a maximal daily dose of 40 mg of testosterone in the intervention arm. Evaluation of primary and secondary endpoints will be performed at baseline, 26 weeks post-randomization, at the end of treatment (52 weeks) and 3 months after completion of treatment (week 64). This study is the first to investigate the effect of testosterone substitution in testicular cancer survivors with mild Leydig cell insufficiency. If positive, it may change the clinical handling of testicular cancer survivors with borderline low levels of testosterone. ClinicalTrials.gov : NCT02991209 (November 25, 2016).

Evaluating clinical trial design: systematic review of randomized vehicle-controlled trials for determining efficacy of benzoyl peroxide topical therapy for acne.

PubMed

Lamel, Sonia A; Sivamani, Raja K; Rahvar, Maral; Maibach, Howard I

2015-11-01

Determined efficacies of benzoyl peroxide may be affected by study design, implementation, and vehicle effects. We sought to elucidate areas that may allow improvement in determining accurate treatment efficacies by determining rates of active treatment and vehicle responders in randomized controlled trials assessing the efficacy of topical benzoyl peroxide to treat acne. We conducted a systematic review of randomized vehicle-controlled trials evaluating the efficacy of topical benzoyl peroxide for the treatment of acne. We compared response rates of vehicle treatment arms versus those in benzoyl peroxide arms. Twelve trials met inclusion criteria with 2818 patients receiving benzoyl peroxide monotherapy treatment and 2004 receiving vehicle treatment. The average percent reduction in total number of acne lesions was 44.3 (SD = 9.2) and 27.8 (SD = 21.0) for the active and vehicle treatment groups, respectively. The average reduction in non-inflammatory lesions was 41.5 % (SD = 9.4) in the active treatment group and 27.0 % (SD = 20.9) in the vehicle group. The average percent decrease in inflammatory lesions was 52.1 (SD = 10.4) in the benzoyl peroxide group and 34.7 (SD = 22.7) in the vehicle group. The average percentage of participants achieving success per designated study outcomes was 28.6 (SD = 17.3) and 15.2 (SD = 9.5) in the active treatment and vehicle groups, respectively. Patient responses in randomized controlled trials evaluating topical acne therapies may be affected by clinical trial design, implementation, the biologic effects of vehicles, and natural disease progression. "No treatment" groups may facilitate determination of accurate treatment efficacies.

Rationale and baseline characteristics of PREVENT: a second-generation intervention trial in subjects at-risk (prodromal) of developing first-episode psychosis evaluating cognitive behavior therapy, aripiprazole, and placebo for the prevention of psychosis.

PubMed

Bechdolf, Andreas; Müller, Hendrik; Stützer, Hartmut; Wagner, Michael; Maier, Wolfgang; Lautenschlager, Marion; Heinz, Andreas; de Millas, Walter; Janssen, Birgit; Gaebel, Wolfgang; Michel, Tanja Maria; Schneider, Frank; Lambert, Martin; Naber, Dieter; Brüne, Martin; Krüger-Özgürdal, Seza; Wobrock, Thomas; Riedel, Michael; Klosterkötter, Joachim

2011-09-01

Antipsychotics, cognitive behavioral therapy (CBT), and omega-3-fatty acids have been found superior to control conditions as regards prevention of psychosis in people at-risk of first-episode psychosis. However, no large-scale trial evaluating the differential efficacy of CBT and antipsychotics has been performed yet. In PREVENT, we evaluate CBT, aripiprazole, and clinical management (CM) as well as placebo and CM for the prevention of psychosis in a randomized, double-blind, placebo-controlled trial with regard to the antipsychotic intervention and a randomized controlled trial with regard to the CBT intervention with blinded ratings. The hypotheses are first that CBT and aripiprazole and CM are superior to placebo and CM and second that CBT is not inferior to aripiprazole and CM combined. The primary outcome is transition to psychosis. By November 2010, 156 patients were recruited into the trial. The subjects were substantially functionally compromised (Social and Occupational Functioning Assessment Scale mean score 52.5) and 78.3% presented with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition axis I comorbid diagnosis. Prior to randomization, 51.5% of the participants preferred to be randomized into the CBT arm, whereas only 12.9% preferred pharmacological treatment. First, assessments of audiotaped treatment sessions confirmed the application of CBT-specific skills in the CBT condition and the absence of those in CM. The overall quality rating of the CBT techniques applied in the CBT condition was good. When the final results of the trial are available, PREVENT will substantially expand the current limited evidence base for best clinical practice in people at-risk (prodromal) of first-episode psychosis.

Case studies combined with or without concept maps improve critical thinking in hospital-based nurses: a randomized-controlled trial.

PubMed

Huang, Yu-Chuan; Chen, Hsing-Hsia; Yeh, Mei-Ling; Chung, Yu-Chu

2012-06-01

Critical thinking (CT) is essential to the exercise of professional judgment. As nurses face increasingly complex health-care situations, critical thinking can promote appropriate clinical decision-making and improve the quality of nursing care. This study aimed to evaluate the effects of a program of case studies, alone (CS) or combined with concept maps (CSCM), on improving CT in clinical nurses. The study was a randomized controlled trial. The experimental group participated in a 16-week CSCM program, whereas the control group participated in a CS program of equal duration. A randomized-controlled trial with a multistage randomization process was used to select and to assign participants, ultimately resulting in 67 nurses in each group. Data were collected before and after the program using the California Critical Thinking Skill Test (CCTST) and the California Critical Thinking Disposition Inventory (CCTDI). After the programs, there were significant differences between the two groups in the critical thinking skills of analysis, evaluation, inference, deduction, and induction. There was also an overall significant difference, and a significant difference in the specific disposition of open-mindedness. This study supports the application of case studies combined with concept maps as a hospital-based teaching strategy to promote development of critical thinking skills and encourage dispositions for nurses. The CSCM resulted in greater improvements in all critical thinking skills of as well as the overall and open-minded affective dispositions toward critical thinking, compared with the case studies alone. An obvious improvement in the CSCM participants was the analytic skill and disposition. Further longitudinal studies and data collection from multisite evaluations in a range of geographic locales are warranted. Copyright © 2012 Elsevier Ltd. All rights reserved.

Evaluating Periodontal Treatment to Prevent Cardiovascular Disease: Challenges and Possible Solutions.

PubMed

Merchant, Anwar T; Virani, Salim S

2017-01-01

Periodontal disease is correlated with cardiovascular disease (CVD) in observational studies, but a causal connection has not been established. The empirical evidence linking periodontal disease and CVD consists of a large body of observational and mechanistic studies, but a limited number of clinical trials evaluating the effects of periodontal treatment on surrogate CVD endpoints. No randomized controlled trial has been conducted to evaluate the effect of periodontal treatment on CVD risk. In this review, we have summarized these data, described possible biological mechanisms linking periodontal disease and CVD, discussed barriers to conducting a randomized controlled trial to evaluate this hypothesis, and provided an alternative analytical approach using causal inference methods to answer the question. The public health implications of addressing this question can be significant because periodontal disease is under-treated, and highly prevalent among adults at risk of CVD. Even a small beneficial effect of periodontal treatment on CVD risk can be important.

[Scales to evaluate pain in elderly patients suffering from dementia. Help-tools for the physiotherapist, doctor, nurse and occupational therapist].

PubMed

Rodríguez-Mansilla, Juan; Jiménez-Palomares, María; González-López-Arza, María Victoria

2014-01-01

The purpose of this study was to determine which scales are being used to evaluate pain in old people suffering from dementia. A search strategy was developed to retrieve all articles (randomized controlled trials and clinical trials without randomization) published in MEDLINE, Cochrane Library Plus, PEDro and Dialnet and BMC Geriatrics from January 2000 to January 2012. Exclusion criteria were articles that did not use scales for evaluating pain in elderly patients suffering from dementia, and other type of articles (case studies, reviews...). Finally, 13 studies were included in this review. From the results obtained it appears that more studies are needed to confirm the pain scales used for the elderly suffering from dementia. Observational scales may be useful to evaluate pain in these patients. Copyright © 2012 SEGG. Published by Elsevier Espana. All rights reserved.

Thai Massage, and Thai Herbal Compress versus Oral Ibuprofen in Symptomatic Treatment of Osteoarthritis of the Knee: A Randomized Controlled Trial

PubMed Central

2014-01-01

The aim of this study was to verify the clinical responses to Thai massage (TM) and Thai herbal compression (THC) for treating osteoarthritis (OA) of the knee in comparison to oral ibuprofen. This study was a randomized, evaluator-blind, controlled trial. Sixty patients with OA of the knee were randomly assigned to receive either a one-hour session of TM or THC (three times weekly) or oral ibuprofen (three times daily). The duration of treatment was three weeks. The clinical assessments included visual analog scale assessing pain and stiffness, Lequesne's functional index, time for climbing up ten steps, and physician's and patient's overall opinions on improvement. In a within-group comparison, each treatment modality caused a significant improvement of all variables determined for outcome assessments. In an among group comparison, all modalities provided nearly comparable clinical efficacy after a three-week symptomatic treatment of OA of the knee, in which a trend toward greatest improvement was likely to be found in THC group. In conclusion, TM and THC generally provided comparable clinical efficacy to oral ibuprofen after three weeks of treatment and could be considered as complementary and alternative treatments for OA of the knee. PMID:25254207

Smoking cessation and reduction in schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial.

PubMed

Caponnetto, Pasquale; Polosa, Riccardo; Auditore, Roberta; Minutolo, Giuseppe; Signorelli, Maria; Maglia, Marilena; Alamo, Angela; Palermo, Filippo; Aguglia, Eugenio

2014-03-22

It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population. We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders". The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test. The main strengths of the SCARIS study are the following: it's the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).The goal is to propose an effective intervention to reduce the risk of tobacco smoking, as a complementary tool to treat tobacco addiction in schizophrenia. ClinicalTrials.gov, NCT01979796.

Efficacy of pre-exercise low-level laser therapy on isokinetic muscle performance in individuals with type 2 diabetes mellitus: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Type 2 diabetes, also known non-insulin-dependent diabetes, is the most prevalent type of the disease and involves defects in the secretion and action of insulin. The aim of the proposed study is to evaluate the efficacy of pre-exercise low-level laser therapy (LLLT) on muscle performance of the quadriceps femoris in individuals with type 2 diabetes. Methods/Design A double-blind, randomized, controlled clinical trial will be carried out in two treatment phases. In the first phase, quadriceps muscle performance will be evaluated using an isokinetic dynamometer and the levels of creatine kinase and lactate dehydrogenase (biochemical markers of muscle damage) will be determined. The participants will then be allocated to four LLLT groups through a randomization process using opaque envelopes: Group A (4 Joules), Group B (6 Joules), Group C (8 Joules) and Group D (0 Joules; placebo). Following the administration of LLLT, the participants will be submitted to an isokinetic eccentric muscle fatigue protocol involving the quadriceps muscle bilaterally. Muscle performance and biochemical markers of muscle damage will be evaluated again immediately after as well as 24 and 48 hours after the experimental protocol. One week after the last evaluation the second phase will begin, during which Groups A, B and C will receive the LLLT protocol that achieved the best muscle performance in phase 1 for a period of 4 weeks. At the end of this period, muscle performance will be evaluated again. The protocol for this study is registered with the World Health Organization under Universal Trial Number U1111-1146-7109. Discussion The purpose of this randomized clinical trial is to evaluate the efficacy of pre-exercise LLLT on the performance of the quadriceps muscle (peak torque, total muscle work, maximum power and fatigue index – normalized by body mass) in individuals with DM-2. The study will support the practice of evidence-based to the use of LLLT in improving muscle performance in Individuals with DM-2. Data will be published after the study is completed. PMID:24716713

Efficacy of pre-exercise low-level laser therapy on isokinetic muscle performance in individuals with type 2 diabetes mellitus: study protocol for a randomized controlled trial.

PubMed

Gomes, Cid André Fidelis de Paula; Leal-Junior, Ernesto Cesar Pinto; Biasotto-Gonzalez, Daniela Aparecida; El-Hage, Yasmin; Politti, Fabiano; Gonzalez, Tabajara de Oliveira; Dibai-Filho, Almir Vieira; de Oliveira, Adriano Rodrigues; Frigero, Marcelo; Antonialli, Fernanda Colella; Vanin, Adriane Aver; de Tarso Camillo de Carvalho, Paulo

2014-04-09

Type 2 diabetes, also known non-insulin-dependent diabetes, is the most prevalent type of the disease and involves defects in the secretion and action of insulin. The aim of the proposed study is to evaluate the efficacy of pre-exercise low-level laser therapy (LLLT) on muscle performance of the quadriceps femoris in individuals with type 2 diabetes. A double-blind, randomized, controlled clinical trial will be carried out in two treatment phases. In the first phase, quadriceps muscle performance will be evaluated using an isokinetic dynamometer and the levels of creatine kinase and lactate dehydrogenase (biochemical markers of muscle damage) will be determined. The participants will then be allocated to four LLLT groups through a randomization process using opaque envelopes: Group A (4 Joules), Group B (6 Joules), Group C (8 Joules) and Group D (0 Joules; placebo). Following the administration of LLLT, the participants will be submitted to an isokinetic eccentric muscle fatigue protocol involving the quadriceps muscle bilaterally. Muscle performance and biochemical markers of muscle damage will be evaluated again immediately after as well as 24 and 48 hours after the experimental protocol. One week after the last evaluation the second phase will begin, during which Groups A, B and C will receive the LLLT protocol that achieved the best muscle performance in phase 1 for a period of 4 weeks. At the end of this period, muscle performance will be evaluated again. The protocol for this study is registered with the World Health Organization under Universal Trial Number U1111-1146-7109. The purpose of this randomized clinical trial is to evaluate the efficacy of pre-exercise LLLT on the performance of the quadriceps muscle (peak torque, total muscle work, maximum power and fatigue index - normalized by body mass) in individuals with DM-2. The study will support the practice of evidence-based to the use of LLLT in improving muscle performance in Individuals with DM-2. Data will be published after the study is completed.

Structural Alteration of Gut Microbiota during the Amelioration of Human Type 2 Diabetes with Hyperlipidemia by Metformin and a Traditional Chinese Herbal Formula: a Multicenter, Randomized, Open Label Clinical Trial

PubMed Central

2018-01-01

ABSTRACT Accumulating evidence implicates gut microbiota as promising targets for the treatment of type 2 diabetes mellitus (T2DM). With a randomized clinical trial, we tested the hypothesis that alteration of gut microbiota may be involved in the alleviation of T2DM with hyperlipidemia by metformin and a specifically designed herbal formula (AMC). Four hundred fifty patients with T2DM and hyperlipidemia were randomly assigned to either the metformin- or AMC-treated group. After 12 weeks of treatment, 100 patients were randomly selected from each group and assessed for clinical improvement. The effects of the two drugs on the intestinal microbiota were evaluated by analyzing the V3 and V4 regions of the 16S rRNA gene by Illumina sequencing and multivariate statistical methods. Both metformin and AMC significantly alleviated hyperglycemia and hyperlipidemia and shifted gut microbiota structure in diabetic patients. They significantly increased a coabundant group represented by Blautia spp., which significantly correlated with the improvements in glucose and lipid homeostasis. However, AMC showed better efficacies in improving homeostasis model assessment of insulin resistance (HOMA-IR) and plasma triglyceride and also exerted a larger effect on gut microbiota. Furthermore, only AMC increased the coabundant group represented by Faecalibacterium spp., which was previously reported to be associated with the alleviation of T2DM in a randomized clinical trial. Metformin and the Chinese herbal formula may ameliorate type 2 diabetes with hyperlipidemia via enriching beneficial bacteria, such as Blautia and Faecalibacterium spp. PMID:29789365

A systematic review and meta-analysis of randomized controlled trials of adjunctive ketamine in electroconvulsive therapy: efficacy and tolerability.

PubMed

McGirr, Alexander; Berlim, Marcelo T; Bond, David J; Neufeld, Nicholas H; Chan, Peter Y; Yatham, Lakshmi N; Lam, Raymond W

2015-03-01

Electroconvulsive therapy (ECT) remains one of the most effective tools in the psychiatric treatment armamentarium, particularly for refractory depression. Yet, there remains a subset of patients who do not respond to ECT or for whom clinically adequate seizures cannot be elicited, for whom ketamine has emerged as a putative augmentation agent. We searched EMBASE, PsycINFO, CENTRAL, and MEDLINE from 1962 to April 2014 to identify randomized controlled trials evaluating ketamine in ECT (PROSPERO #CRD42014009035). Clinical remission, response, and change in depressive symptom scores were extracted by two independent raters. Adverse events were recorded. Drop-outs were assessed as a proxy for acceptability. Meta-analyses employed a random effects model. Data were synthesized from 5 RCTs, representing a total of 182 patients with major depressive episodes (n = 165 Major Depressive Disorder, n = 17 Bipolar Disorder). ECT with ketamine augmentation was not associated with higher rates of clinical remission (Risk Difference (RD) = 0.00; 95%CI = -0.08 to 0.10), response (RD = -0.01; 95%CI = -0.11 to 0.08), or improvements in depressive symptoms (SMD = 0.38; 95%CI = -0.41 to 1.17). Ketamine augmentation was associated with higher rates of confusion/disorientation/prolonged delirium (OR = 6.59, 95%CI: 1.28-33.82, NNH = 3), but not agitation, hypertension or affective switches. Our meta-analysis of randomized controlled trials of ketamine augmentation in the ECT setting suggests a lack of clinical efficacy, and an increased likelihood of confusion. Individuals for whom adequate seizures or therapeutic response cannot be obtained have not been studied using randomized controlled designs. Additional research is required to address the role of ketamine in this population. Copyright © 2015 Elsevier Ltd. All rights reserved.

Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial.

PubMed

Cardaropoli, Daniele; Tamagnone, Lorenzo; Roffredo, Alessandro; Gaveglio, Lorena

2012-03-01

Connective tissue graft (CTG) plus coronally advanced flap (CAF) is the reference therapy for root coverage. The aim of the present study is to evaluate the use of a porcine collagen matrix (PCM) plus CAF as an alternative to CTG+CAF for the treatment of gingival recessions (REC), in a prospective randomized, controlled clinical trial. Eighteen adult patients participated in this study. The patients presented 22 single Miller's Class I or II REC, randomly assigned to the test (PCM+CAF) or control (CTG+CAF) group. REC, probing depth, clinical attachment level (CAL), and width of keratinized tissue (KG) were evaluated at 12 months. In addition, the gingival thickness (GT) was measured 1mm apical to the bottom of the sulcus. At 12 months, mean REC was 0.23 mm for test sites and 0.09 mm for control sites (P <0.01), whereas percentage of root coverage was 94.32% and 96.97%, respectively. CAL gain was 2.41 mm in test sites and 2.95 mm in control sites (P <0.01). KG gain was 1.23 mm in the test group and 1.27 mm in the control group (P <0.01). In test sites, GT changed from 0.82 to 1.82 mm, and in control sites, from 0.86 to 2.09 mm (P <0.01). Within the limits of the study, both treatment procedures resulted in significant reduction in REC at 12 months. No statistically significant differences were found between PCM+CAF and CTG+CAF with regard to any clinical parameter. The collagen matrix represents a possible alternative to CTG.

Comparative evidence on harms in pediatric randomized clinical trials from less developed versus more developed countries is limited.

PubMed

Tedesco, Dario; Farid-Kapadia, Mufiza; Offringa, Martin; Bhutta, Zulfiqar A; Maldonado, Yvonne; Ioannidis, John P A; Contopoulos-Ioannidis, Despina G

2018-03-01

Evaluate comparative harm rates from medical interventions in pediatric randomized clinical trials (RCTs) from more developed (MDCs) and less developed countries (LDCs). Meta-epidemiologic empirical evaluation of Cochrane Database of Systematic Reviews (June 2014) meta-analyses reporting clinically important harm-outcomes (severe adverse events [AEs], discontinuations due to AEs, any AE, and mortality) that included at least one pediatric RCT from MDCs and at least one from LDCs. We estimated relative odds ratios (RORs) for each harm, within each meta-analysis, between RCTs from MDCs and LDCs and calculated random-effects-summary-RORs (sRORs) for each harm across multiple meta-analyses. Only 1% (26/2,363) of meta-analyses with clinically important harm-outcomes in the entire Cochrane Database of Systematic Reviews included pediatric RCTs both from MDCs and LDCs. We analyzed 26 meta-analyses with 244 data sets from pediatric RCTs, 116 from MDCs and 128 from LDCs (64 and 66 unique RCTs respectively). The summary ROR was 0.92 (95% confidence intervals: 0.78-1.08) for severe AEs; 1.13 (0.54-2.34) for discontinuations due to AEs; 1.10 (0.77-1.59) for any AE; and 0.99 (0.61-1.61) for mortality and for the all-harms-combined-end point 0.96 (0.83-1.10). Differences of ROR-point-estimates ≥2-fold between MDCs and LDCs were identified in 35% of meta-analyses. We found no major systematic differences in harm rates in pediatric trials between MDCs and LDCs, but data on harms in children were overall very limited. Copyright © 2017 Elsevier Inc. All rights reserved.

Impact of selected magnetic fields on the therapeutic effect in patients with lumbar discopathy: A prospective, randomized, single-blinded, and placebo-controlled clinical trial.

PubMed

Taradaj, Jakub; Ozon, Marcin; Dymarek, Robert; Bolach, Bartosz; Walewicz, Karolina; Rosińczuk, Joanna

2018-03-23

Interdisciplinary physical therapy together with pharmacological treatment constitute conservative treatment strategies related to low back pain (LBP). There is still a lack of high quality studies aimed at an objective evaluation of physiotherapeutic procedures according to their effectiveness in LBP. The aim of this study is to carry out a prospective, randomized, single-blinded, and placebocontrolled clinical trial to evaluate the effectiveness of magnetic fields in discopathy-related LBP. A group of 177 patients was assessed for eligibility based on inclusion and exclusion criteria. In the end, 106 patients were randomly assigned into 5 comparative groups: A (n = 23; magnetic therapy: 10 mT, 50 Hz); B (n = 23; magnetic therapy: 5 mT, 50 Hz); C (n = 20; placebo magnetic therapy); D (n = 20; magnetic stimulation: 49.2 μT, 195 Hz); and E (n = 20; placebo magnetic stimulation). All patients were assessed using tests for pain intensity, degree of disability and range of motion. Also, postural stability was assessed using a stabilographic platform. In this study, positive changes in all clinical outcomes were demonstrated in group A (p < 0.05). The most effective clinical effect was observed for pain reduction (p < 0.05), improvement of the range of motion (p < 0.05) and functional ability of the spine (p <0.05). It is also worth noting that the effects in the majority of the measured indicators were mostly short-term (p > 0.05). It was determined that the application of magnetic therapy (10 mT, 50 Hz, 20 min) significantly reduces pain symptoms and leads to an improvement of functional ability in patients with LBP.

Lidocaine for systemic sclerosis: a double-blind randomized clinical trial

PubMed Central

2011-01-01

Background Systemic sclerosis (scleroderma; SSc) is an orphan disease with the highest case-specific mortality of any connective-tissue disease. Excessive collagen deposit in affected tissues is a key for the disease's pathogenesis and comprises most of the clinical manifestations. Lidocaine seems to be an alternative treatment for scleroderma considering that: a) the patient's having excessive collagen deposits in tissues affected by scleroderma; b) the patient's demonstrating increased activity of the enzyme prolyl hydroxylase, an essential enzyme for the biosynthesis of collagen; and c) lidocaine's reducing the activity of prolyl hydroxylase. The aim of this study was to evaluate the efficacy and safety of lidocaine in treating scleroderma. Methods A randomized double-blind clinical trial included 24 patients with scleroderma randomized to receive lidocaine or placebo intravenously in three cycles of ten days each, with a one-month interval between them. Outcomes: cutaneous (modified Rodnan skin score), oesophageal (manometry) and microvascular improvement (nailfold capillaroscopy); improvement in subjective self-assessment and in quality of life (HAQ). Results There was no statistically significant difference between the groups for any outcome after the treatment and after 6-months follow-up. Improvement in modified Rodnan skin score occurred in 66.7% and 50% of placebo and lidocaine group, respectively (p = 0.408). Both groups showed an improvement in subjective self-assessment, with no difference between them. Conclusions Despite the findings of a previous cohort study favouring the use of lidocaine, this study demonstrated that lidocaine at this dosage and means of administration showed a lack of efficacy for treating scleroderma despite the absence of significant adverse effects. However, further similar clinical trials are needed to evaluate the efficacy of lidocaine when administered in different dosages and by other means. PMID:21299861

REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study.

PubMed

Tajstra, Mateusz; Sokal, Adam; Gwóźdź, Arkadiusz; Wilczek, Marcin; Gacek, Adam; Wojciechowski, Konrad; Gadula-Gacek, Elżbieta; Adamowicz-Czoch, Elżbieta; Chłosta-Niepiekło, Katarzyna; Milewski, Krzysztof; Rozentryt, Piotr; Kalarus, Zbigniew; Gąsior, Mariusz; Poloński, Lech

2017-07-01

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow-up is crucial. Remote monitoring (RM) has been widely put into practice in the management of CIEDs but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate (RESULT) study is to evaluate the impact of RM on the clinical status of patients with ICDs or CRT-Ds using an integrated platform. Six hundred consecutive patients with ICDs or CRT-Ds implanted will be prospectively randomized to either a traditional or RM-based follow-up model. The primary clinical endpoint will be a composite of all-cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT02409225). © 2016 Wiley Periodicals, Inc.

Telephone cognitive-behavioral therapy for adolescents with obsessive-compulsive disorder: a randomized controlled non-inferiority trial.

PubMed

Turner, Cynthia M; Mataix-Cols, David; Lovell, Karina; Krebs, Georgina; Lang, Katie; Byford, Sarah; Heyman, Isobel

2014-12-01

Many adolescents with obsessive-compulsive disorder (OCD) do not have access to evidence-based treatment. A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy (TCBT) for adolescents with OCD compared to standard clinic-based, face-to-face CBT. Seventy-two adolescents, aged 11 through 18 years with primary OCD, and their parents were randomized to receive specialist TCBT or CBT. The intervention provided differed only in the method of treatment delivery. All participants received up to 14 sessions of CBT, incorporating exposure with response prevention (E/RP), provided by experienced therapists. The primary outcome measure was the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). Blind assessor ratings were obtained at midtreatment, posttreatment, 3-month, 6-month, and 12-month follow-up. Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment, 3-month, and 6-month follow-up. At 12-month follow-up, there were no significant between-group differences on the CY-BOCS, but the confidence intervals exceeded the non-inferiority threshold. All secondary measures confirmed non-inferiority at all assessment points. Improvements made during treatment were maintained through to 12-month follow-up. Participants in each condition reported high levels of satisfaction with the intervention received. TCBT is an effective treatment and is not inferior to standard clinic-based CBT, at least in the midterm. This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD. Clinical trial registration information-Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD); http://www.controlled-trials.com; ISRCTN27070832. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

Telephone Cognitive-Behavioral Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Non-inferiority Trial

PubMed Central

Turner, Cynthia M.; Mataix-Cols, David; Lovell, Karina; Krebs, Georgina; Lang, Katie; Byford, Sarah; Heyman, Isobel

2014-01-01

Objective Many adolescents with obsessive-compulsive disorder (OCD) do not have access to evidence-based treatment. A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy (TCBT) for adolescents with OCD compared to standard clinic-based, face-to-face CBT. Method Seventy-two adolescents, aged 11 through 18 years with primary OCD, and their parents were randomized to receive specialist TCBT or CBT. The intervention provided differed only in the method of treatment delivery. All participants received up to 14 sessions of CBT, incorporating exposure with response prevention (E/RP), provided by experienced therapists. The primary outcome measure was the Children’s Yale–Brown Obsessive-Compulsive Scale (CY-BOCS). Blind assessor ratings were obtained at midtreatment, posttreatment, 3-month, 6-month, and 12-month follow-up. Results Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment, 3-month, and 6-month follow-up. At 12-month follow-up, there were no significant between-group differences on the CY-BOCS, but the confidence intervals exceeded the non-inferiority threshold. All secondary measures confirmed non-inferiority at all assessment points. Improvements made during treatment were maintained through to 12-month follow-up. Participants in each condition reported high levels of satisfaction with the intervention received. Conclusion TCBT is an effective treatment and is not inferior to standard clinic-based CBT, at least in the midterm. This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD. Clinical trial registration information–Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD); http://www.controlled-trials.com; ISRCTN27070832. PMID:25457928

Calorie intake and patient outcomes in severe acute kidney injury: findings from The Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study trial

PubMed Central

2014-01-01

Introduction Current practice in the delivery of caloric intake (DCI) in patients with severe acute kidney injury (AKI) receiving renal replacement therapy (RRT) is unknown. We aimed to describe calorie administration in patients enrolled in the Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study and to assess the association between DCI and clinical outcomes. Methods We performed a secondary analysis in 1456 patients from the RENAL trial. We measured the dose and evolution of DCI during treatment and analyzed its association with major clinical outcomes using multivariable logistic regression, Cox proportional hazards models, and time adjusted models. Results Overall, mean DCI during treatment in ICU was low at only 10.9 ± 9 Kcal/kg/day for non-survivors and 11 ± 9 Kcal/kg/day for survivors. Among patients with a lower DCI (below the median) 334 of 729 (45.8%) had died at 90-days after randomization compared with 316 of 727 (43.3%) patients with a higher DCI (above the median) (P = 0.34). On multivariable logistic regression analysis, mean DCI carried an odds ratio of 0.95 (95% confidence interval (CI): 0.91-1.00; P = 0.06) per 100 Kcal increase for 90-day mortality. DCI was not associated with significant differences in renal replacement (RRT) free days, mechanical ventilation free days, ICU free days and hospital free days. These findings remained essentially unaltered after time adjusted analysis and Cox proportional hazards modeling. Conclusions In the RENAL study, mean DCI was low. Within the limits of such low caloric intake, greater DCI was not associated with improved clinical outcomes. Trial registration ClinicalTrials.gov number, NCT00221013 PMID:24629036

Improved power for characterizing longitudinal amyloid-β PET changes and evaluating amyloid-modifying treatments with a cerebral white matter reference region.

PubMed

Chen, Kewei; Roontiva, Auttawut; Thiyyagura, Pradeep; Lee, Wendy; Liu, Xiaofen; Ayutyanont, Napatkamon; Protas, Hillary; Luo, Ji Luo; Bauer, Robert; Reschke, Cole; Bandy, Daniel; Koeppe, Robert A; Fleisher, Adam S; Caselli, Richard J; Landau, Susan; Jagust, William J; Weiner, Michael W; Reiman, Eric M

2015-04-01

In this article, we describe an image analysis strategy with improved power for tracking longitudinal amyloid-β (Aβ) PET changes and evaluating Aβ-modifying treatments. Our aims were to compare the power of template-based cerebellar, pontine, and cerebral white matter reference regions to track 24-mo florbetapir standardized uptake value (SUV) ratio (SUVR) changes; to relate those changes to 24-mo clinical declines; and to evaluate Aβ-modifying treatments in Aβ-positive (Aβ+) and Aβ-negative (Aβ-) patients with probable Alzheimer dementia (pAD), in patients with mild cognitive impairment (MCI), in cognitively normal controls (NCs), and in cognitively normal apolipoprotein E4 (APOE4) carriers and noncarriers. We used baseline and follow-up (∼24 mo) florbetapir PET scans from 332 Aβ+ and Aβ- subjects participating in the multicenter Alzheimer's Disease Neuroimaging Initiative. Each of the proposed analyses included 31 pAD patients, 187 MCI patients, and 114 NCs. Cerebral-to-white matter, cerebellar, and pontine SUVRs were characterized in terms of their longitudinal variability; their power to track longitudinal fibrillar Aβ increases in Aβ+ and Aβ- subgroups and cognitively normal APOE4 carriers and noncarriers; the sample sizes needed to detect attenuated accumulation of or clearance of fibrillar Aβ accumulation in randomized clinical trials; and their ability to relate 24-mo fibrillar Aβ increases to clinical declines. As predicted, cerebral-to-white matter SUVR changes were significantly less variable and had significantly greater power to detect 24-mo fibrillar Aβ increases and evaluate Aβ-modifying treatment effects in Aβ+ pAD, MCI, and NC subjects and cognitively normal APOE4 carriers. They were also distinguished by the ability to detect significant associations between 24-mo Aβ increases and clinical declines. A cerebral white matter reference region may improve the power to track longitudinal fibrillar Aβ increases, to characterize their relationship to longitudinal clinical declines, and to evaluate Aβ-modifying treatments in randomized clinical trials. © 2015 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

The Design of Phase II Clinical Trials Testing Cancer Therapeutics: Consensus Recommendations from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee

PubMed Central

Seymour, Lesley; Ivy, S. Percy; Sargent, Daniel; Spriggs, David; Baker, Laurence; Rubinstein, Larry; Ratain, Mark J; Le Blanc, Michael; Stewart, David; Crowley, John; Groshen, Susan; Humphrey, Jeffrey S; West, Pamela; Berry, Donald

2010-01-01

The optimal design of phase II studies continues to be the subject of vigorous debate, especially with regards to studies of newer molecularly targeted agents. The observations that many new therapeutics ‘fail’ in definitive phase III studies, coupled with the numbers of new agents to be tested as well as the increasing costs and complexity of clinical trials further emphasizes the critical importance of robust and efficient phase II design. The Clinical Trial Design Task Force(CTD-TF)of the NCI Investigational Drug Steering Committee (IDSC) has published a series of discussion papers on Phase II trial design in Clinical Cancer Research. The IDSC has developed formal recommendations regarding aspects of phase II trial design which are the subject of frequent debate such as endpoints(response vs. progression free survival), randomization(single arm designs vs. randomization), inclusion of biomarkers, biomarker based patient enrichment strategies, and statistical design(e.g. two stage designs vs. multiple-group adaptive designs). While these recommendations in general encourage the use of progression-free survival as the primary endpoint, the use of randomization, the inclusion of biomarkers and the incorporation of newer designs, we acknowledge that objective response as an endpoint, and single arm designs, remain relevant in certain situations. The design of any clinical trial should always be carefully evaluated and justified based on the characteristic specific to the situation. PMID:20215557

A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation.

PubMed

Lopez, Alexa A; Cobb, Caroline O; Yingst, Jessica M; Veldheer, Susan; Hrabovsky, Shari; Yen, Miao-Shan; Foulds, Jonathan; Eissenberg, Thomas

2016-03-03

This study is a systematic evaluation of a novel tobacco product, electronic cigarettes (ECIGs) using a two-site, four-arm, 6-month, parallel-group randomized controlled trial (RCT) with a follow-up to 9 months. Virginia Commonwealth University is the primary site and Penn State University is the secondary site. This RCT design is important because it is informed by analytical work, clinical laboratory results, and qualitative/quantitative findings regarding the specific ECIG products used. Participants (N = 520) will be randomized across sites and must be healthy smokers of >9 cigarettes for at least one year, who have not had a quit attempt in the prior month, are not planning to quit in the next 6 months, and are interested in reducing cigarette intake. Participants will be randomized into one of four 24-week conditions: a cigarette substitute that does not produce an inhalable aerosol; or one of three ECIG conditions that differ by nicotine concentration 0, 8, or 36 mg/ml. Blocked randomization will be accomplished with a 1:1:1:1 ratio of condition assignments at each site. Specific aims are to: characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk; determine tobacco abstinence symptom and adverse event profile associated with real-world ECIG use; and examine the influence of ECIG use on conventional tobacco product use. Liquid nicotine concentration-related differences on these study outcomes are predicted. Participants and research staff in contact with participants will be blinded to the nicotine concentration in the ECIG conditions. Results from this study will inform knowledge concerning ECIG use as well as demonstrate a model that may be applied to other novel tobacco products. The model of using prior empirical testing of ECIG devices should be considered in other RCT evaluations. TRN: NCT02342795 , registered December 16, 2014.

Performance of Universal Adhesive in Primary Molars After Selective Removal of Carious Tissue: An 18-Month Randomized Clinical Trial.

PubMed

Lenzi, Tathiane Larissa; Pires, Carine Weber; Soares, Fabio Zovico Maxnuck; Raggio, Daniela Prócida; Ardenghi, Thiago Machado; de Oliveira Rocha, Rachel

2017-09-15

To evaluate the 18-month clinical performance of a universal adhesive, applied under different adhesion strategies, after selective carious tissue removal in primary molars. Forty-four subjects (five to 10 years old) contributed with 90 primary molars presenting moderately deep dentin carious lesions on occlusal or occluso-proximal surfaces, which were randomly assigned following either self-etch or etch-and-rinse protocol of Scotchbond Universal Adhesive (3M ESPE). Resin composite was incrementally inserted for all restorations. Restorations were evaluated at one, six, 12, and 18 months using the modified United States Public Health Service criteria. Survival estimates for restorations' longevity were evaluated using the Kaplan-Meier method. Multivariate Cox regression analysis with shared frailty to assess the factors associated with failures (P<0.05). Estimated survival rates of the restorations were 100 percent, 100 percent, 90.6 percent, and 81.4 percent at one, six, 12, and 18 months, respectively. The adhesion strategy did not influence the restorations' longevity (P=0.06; 72.2 percent and 89.7 percent with etch-and-rinse and self-etch mode, respectively). Self-etch and etch-and-rinse strategies did not influence the clinical behavior of universal adhesive used in primary molars after selective carious tissue removal; although there was a tendency for better outcome of the self-etch strategy.

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial.

PubMed

Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H

2013-10-24

Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Clinical Trials NCT01740635.

Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial.

PubMed

Tonttila, Panu P; Lantto, Juha; Pääkkö, Eija; Piippo, Ulla; Kauppila, Saila; Lammentausta, Eveliina; Ohtonen, Pasi; Vaarala, Markku H

2016-03-01

Multiparametric magnetic resonance imaging (MP-MRI) may improve the detection of clinically significant prostate cancer (PCa). To compare MP-MRI transrectal ultrasound (TRUS)-fusion targeted biopsy with routine TRUS-guided random biopsy for overall and clinically significant PCa detection among patients with suspected PCa based on prostate-specific antigen (PSA) values. This institutional review board-approved, single-center, prospective, randomized controlled trial (April 2011 to December 2014) included 130 biopsy-naive patients referred for prostate biopsy based on PSA values (PSA <20 ng/ml or free-to-total PSA ratio ≤0.15 and PSA <10 ng/ml). Patients were randomized 1:1 to the MP-MRI or control group. Patients in the MP-MRI group underwent prebiopsy MP-MRI followed by 10- to 12-core TRUS-guided random biopsy and cognitive MRI/TRUS fusion targeted biopsy. The control group underwent TRUS-guided random biopsy alone. MP-MRI 3-T phased-array surface coil. The primary outcome was the number of patients with biopsy-proven PCa in the MP-MRI and control groups. Secondary outcome measures included the number of positive prostate biopsies and the proportion of clinically significant PCa in the MP-MRI and control groups. Between-group analyses were performed. Overall, 53 and 60 patients were evaluable in the MP-MRI and control groups, respectively. The overall PCa detection rate and the clinically significant cancer detection rate were similar between the MP-MRI and control groups, respectively (64% [34 of 53] vs 57% [34 of 60]; 7.5% difference [95% confidence interval (CI), -10 to 25], p=0.5, and 55% [29 of 53] vs 45% [27 of 60]; 9.7% difference [95% CI, -8.5 to 27], p=0.8). The PCa detection rate was higher than assumed during the planning of this single-center trial. MP-MRI/TRUS-fusion targeted biopsy did not improve PCa detection rate compared with TRUS-guided biopsy alone in patients with suspected PCa based on PSA values. In this randomized clinical trial, additional prostate magnetic resonance imaging (MRI) before prostate biopsy appeared to offer similar diagnostic accuracy compared with routine transrectal ultrasound-guided random biopsy in the diagnosis of prostate cancer. Similar numbers of cancers were detected with and without MRI. ClinicalTrials.gov identifier: NCT01357512. Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults.

PubMed

Pyatak, Elizabeth A; Carandang, Kristine; Vigen, Cheryl; Blanchard, Jeanine; Sequeira, Paola A; Wood, Jamie R; Spruijt-Metz, Donna; Whittemore, Robin; Peters, Anne L

2017-03-01

This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist. In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity. At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence. Participants in the REAL study demonstrate clinically significant medical and psychosocial needs. Copyright © 2017 Elsevier Inc. All rights reserved.

A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections

PubMed Central

2012-01-01

Background Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality. Methods In this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196). Results In the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group. Conclusions Tigecycline was generally safe and effective in the treatment of cSSSIs. Trial registration ClinicalTrials.gov NCT00368537 PMID:23145952

Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Study: Methodology and Baseline Characteristics of a Randomized Controlled Trial Evaluating an Occupation-Based Diabetes Management Intervention for Young Adults

PubMed Central

Pyatak, Elizabeth A.; Carandang, Kristine; Vigen, Cheryl; Blanchard, Jeanine; Sequeira, Paola A.; Wood, Jamie R.; Spruijt-Metz, Donna; Whittemore, Robin; Peters, Anne L.

2017-01-01

Overview This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist. Methods In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study’s primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity. Results At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6 years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrate clinically significant diabetes distress and 27.2% report symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence. Discussion Participants in the REAL study demonstrate clinically significant medical and psychosocial needs. PMID:28064028

A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections.

PubMed

Matthews, Peter; Alpert, Marc; Rahav, Galia; Rill, Denise; Zito, Edward; Gardiner, David; Pedersen, Ron; Babinchak, Timothy; McGovern, Paul C

2012-11-12

Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality. In this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196). In the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group. Tigecycline was generally safe and effective in the treatment of cSSSIs. ClinicalTrials.gov NCT00368537.

Photodynamic therapy as an adjunct to non-surgical periodontal treatment: a randomized, controlled clinical trial.

PubMed

Christodoulides, Nicos; Nikolidakis, Dimitris; Chondros, Panagiotis; Becker, Jürgen; Schwarz, Frank; Rössler, Ralf; Sculean, Anton

2008-09-01

Recent preclinical and clinical data have suggested a potential benefit of photodynamic therapy (PDT) in the treatment of periodontitis. However, there are very limited data from controlled clinical trials evaluating the effect of PDT in the treatment of periodontitis. The aim of this study was to evaluate the clinical and microbiologic effects of the adjunctive use of PDT to non-surgical periodontal treatment. Twenty-four subjects with chronic periodontitis were randomly treated with scaling and root planing followed by a single episode of PDT (test) or scaling and root planing alone (control). Full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), gingival recession, and clinical attachment level (CAL) were measured at baseline and 3 and 6 months after therapy. Primary outcome variables were changes in PD and CAL. Microbiologic evaluation of Aggregatibacter actinomycetemcomitans (previously Actinobacillus actinomycetemcomitans), Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia (previously T. forsythensis), Treponema denticola, Parvimonas micra (previously Peptostreptococcus micros or Micromonas micros), Fusobacterium nucleatum, Campylobacter rectus, Eubacterium nodatum, Eikenella corrodens, and Capnocytophaga spp. was performed at baseline and 3 and 6 months following therapy by using a commercially available polymerase chain reaction test. At 3 and 6 months after treatment, there were no statistically significant differences between the groups with regard to CAL, PD, FMPS, or microbiologic changes. At 3 and 6 months, a statistically significantly greater improvement in FMBS was found in the test group. The additional application of a single episode of PDT to scaling and root planing failed to result in an additional improvement in terms of PD reduction and CAL gain, but it resulted in a significantly higher reduction in bleeding scores compared to scaling and root planing alone.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

PubMed Central

2009-01-01

Background Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. Methods/Design The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. Conclusion The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. Trial registration ClinicalTrials.gov: NCT00964977 PMID:20028566

A Descriptive Study of Nursing Peer-Review Programs in US Magnet® Hospitals.

PubMed

Roberts, Holli; Cronin, Sherill Nones

2017-04-01

The goal of this study was to assess the types of nursing peer review (NPR) programs in US Magnet® organizations. The 2 most predominant models of NPR programs in the literature are performance evaluation and clinical peer review. The literature on clinical peer review is primarily descriptive, outlining structures and anecdotal outcomes. Participants from hospitals holding Magnet recognition were selected using a stratified random-sampling method. A survey developed by the researchers assessed the presence of NPR. If clinical NPR was in place, program design, evaluation measurements, and barriers were explored. Findings suggest wide variability in NPR models. More than one-third of the respondents conduct peer evaluation as the only mechanism of NPR. Most hospitals with a clinical peer-review program reported a case review structure and process measurements not supported by data. The variations noted in this study suggest more research is needed to measure the effectiveness of NPR models and associated outcomes.

Evaluating Random Error in Clinician-Administered Surveys: Theoretical Considerations and Clinical Applications of Interobserver Reliability and Agreement.

PubMed

Bennett, Rebecca J; Taljaard, Dunay S; Olaithe, Michelle; Brennan-Jones, Chris; Eikelboom, Robert H

2017-09-18

The purpose of this study is to raise awareness of interobserver concordance and the differences between interobserver reliability and agreement when evaluating the responsiveness of a clinician-administered survey and, specifically, to demonstrate the clinical implications of data types (nominal/categorical, ordinal, interval, or ratio) and statistical index selection (for example, Cohen's kappa, Krippendorff's alpha, or interclass correlation). In this prospective cohort study, 3 clinical audiologists, who were masked to each other's scores, administered the Practical Hearing Aid Skills Test-Revised to 18 adult owners of hearing aids. Interobserver concordance was examined using a range of reliability and agreement statistical indices. The importance of selecting statistical measures of concordance was demonstrated with a worked example, wherein the level of interobserver concordance achieved varied from "no agreement" to "almost perfect agreement" depending on data types and statistical index selected. This study demonstrates that the methodology used to evaluate survey score concordance can influence the statistical results obtained and thus affect clinical interpretations.

Monoscopic versus stereoscopic photography in screening for clinically significant macular edema.

PubMed

Welty, Christopher J; Agarwal, Anita; Merin, Lawrence M; Chomsky, Amy

2006-01-01

The purpose of the study was to determine whether monoscopic photography could serve as an accurate tool when used to screen for clinically significant macular edema. In a masked randomized fashion, two readers evaluated monoscopic and stereoscopic retinal photographs of 100 eyes. The photographs were evaluated first individually for probable clinically significant macular edema based on the Early Treatment Diabetic Retinopathy Study criteria and then as stereoscopic pairs. Graders were evaluated for sensitivity and specificity individually and in combination. Individually, reader one had a sensitivity of 0.93 and a specificity of 0.77, and reader two had a sensitivity of 0.88 and a specificity of 0.94. In combination, the readers had a sensitivity of 0.91 and a specificity of 0.86. They correlated on 0.76 of the stereoscopic readings and 0.92 of the monoscopic readings. These results indicate that the use of monoscopic retinal photography may be an accurate screening tool for clinically significant macular edema.

The use of mechanistic evidence in drug approval.

PubMed

Aronson, Jeffrey K; La Caze, Adam; Kelly, Michael P; Parkkinen, Veli-Pekka; Williamson, Jon

2018-06-11

The role of mechanistic evidence tends to be under-appreciated in current evidence-based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme seeks to redress this imbalance, by suggesting methods for evaluating mechanistic studies alongside clinical studies. Drug approval is a problematic case for the view that mechanistic evidence should be taken into account, because RCTs are almost always available. Nevertheless, we argue that mechanistic evidence is central to all the key tasks in the drug approval process: in drug discovery and development; assessing pharmaceutical quality; devising dosage regimens; assessing efficacy, harms, external validity, and cost-effectiveness; evaluating adherence; and extending product licences. We recommend that, when preparing for meetings in which any aspect of drug approval is to be discussed, mechanistic evidence should be systematically analysed and presented to the committee members alongside analyses of clinical studies. © 2018 The Authors Journal of Evaluation in Clinical Practice Published by John Wiley & Sons Ltd.

Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

PubMed

Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep

2016-01-01

Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m 2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline release without active dissemination. We hypothesize that the clinics randomized to the intervention group will have a lower proportion of early dialysis starts. Limitations include passive dissemination of the guideline through publication, and lead-time and survivor bias, which favors delayed dialysis initiation. If successful, this active knowledge translation intervention will reduce early dialysis starts, lead to health and economic benefits, and provide a successful framework for evaluating and disseminating future guidelines. ClinicalTrials.gov, NCT02183987.

Calcium plus vitamin D supplementation and joint symptoms in postmenopausal women in the women's health initiative randomized trial.

PubMed

Chlebowski, Rowan T; Pettinger, Mary; Johnson, Karen C; Wallace, Robert; Womack, Catherine; Mossavar-Rahmani, Yasmin; Stefanick, Marcia; Wactawski-Wende, Jean; Carbone, Laura; Lu, Bing; Eaton, Charles; Walitt, Brian; Kooperberg, Charles L

2013-10-01

Low vitamin D intake and levels have been associated with increased joint symptoms in some observational studies but the findings are mixed and evidence from randomized trials sparse. To evaluate the influence of supplemental calcium and vitamin D on joint symptoms in the Women's Health Initiative randomized, placebo-controlled, clinical trial. In post hoc analyses, the results of the Women's Health Initiative randomized clinical trial in which 36,282 postmenopausal women were randomized to receive calcium carbonate (1,000 mg as elemental calcium) with vitamin D-3 (400 IU) daily or placebo were examined in the 6% subgroup of 1,911 participants, oversampled for minorities, who had serial joint symptom assessment. Qualitative information on joint pain and joint swelling was collected by questionnaire before entry and 2 years after randomization. Logistic regression models were used to compare the occurrence and severity of joint symptoms across randomization groups. At baseline, total calcium and vitamin D intakes from diet and supplements were similar in the two randomization groups. In addition, both joint pain (reported by 73%) and joint swelling (reported by 34%) were commonly reported and comparable in the supplement and placebo groups. Two years after randomization, no statistically significant differences between supplement and placebo groups were seen for joint pain frequency (74.6% compared with 75.1% [P=0.79] for supplement and placebo groups, respectively) or joint swelling frequency (34.6% compared with 32.4% [P=0.29], respectively) or in severity scores for either outcome. Subgroup analyses suggested study participants also using nonprotocol calcium supplements at study entry may have less joint pain with supplement group randomization (interaction P=0.02). Joint symptoms are relatively common in postmenopausal women. However, daily supplementation with 1,000 mg calcium carbonate and 400 IU vitamin D-3 in a randomized, placebo-controlled clinical trial setting did not reduce the self-reported frequency or severity of joint symptoms. Copyright © 2013 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Evaluation of Visual Pedagogy in Dental Check-Ups and Preventive Practices among 6-12-Year-Old Children with Autism

ERIC Educational Resources Information Center

Nilchian, Firoozeh; Shakibaei, Fereshteh; Jarah, Zeinab Taghi

2017-01-01

This study was aimed to evaluate the impact of visual pedagogy in dental check-ups and preventive practices among children with autism aged 6-12. In this randomized double-blind clinical trial, the cooperation of 40 children with autism age 6-12. The selected children were equally divided into two groups of case and control (n = 20). The obtained…

10-year results of a new low-monomer cement: follow-up of a randomized RSA study.

PubMed

Söderlund, Per; Dahl, Jon; Röhrl, Stephan; Nivbrant, Bo; Nilsson, Kjell G

2012-12-01

The properties and performance of a new low-monomer cement were examined in this prospective randomized, controlled RSA study. 5-year data have already been published, showing no statistically significant differences compared to controls. In the present paper we present the 10-year results. 44 patients were originally randomized to receive total hip replacement with a Lubinus SPII titanium-aluminum-vanadium stem cemented either with the new Cemex Rx bone cement or with control bone cement, Palacos R. Patients were examined using RSA, Harris hip score, and conventional radiographs. At 10 years, 33 hips could be evaluated clinically and 30 hips could be evaluated with RSA (16 Cemex and 14 Palacos). 9 patients had died and 4 patients were too old or infirm to be investigated. Except for 1 hip that was revised for infection after less than 5 years, no further hips were revised before the 10-year follow-up. There were no statistically significant clinical differences between the groups. The Cemex cement had magnitudes of migration similar to or sometimes lower than those of Palacos cement. In both groups, most hips showed extensive radiolucent lines, probably due to the use of titanium alloy stems. At 10 years, the Cemex bone cement tested performed just as well as the control (Palacos bone cement).

A smart rotary technique versus conventional pulpectomy for primary teeth: A randomized controlled clinical study

PubMed Central

Mokhtari, Negar; Shirazi, Alireza-Sarraf

2017-01-01

Background Techniques with adequate accuracy of working length determination along with shorter duration of treatment in pulpectomy procedure seems to be essential in pediatric dentistry. The aim of the present study was to evaluate the accuracy of root canal length measurement with Root ZX II apex locator and rotary system in pulpectomy of primary teeth. Material and Methods In this randomized control clinical trial complete pulpectomy was performed on 80 mandibular primary molars in 80, 4-6-year-old children. The study population was randomly divided into case and control groups. In control group conventional pulpectomy was performed and in the case group working length was determined by electronic apex locator Root ZXII and instrumented with Mtwo rotary files. Statistical evaluation was performed using Mann-Whitney and Chi-Square tests (P<0.05). Results There were no significant differences between electronic apex locator Root ZXII and conventional method in accuracy of root canal length determination. However significantly less time was needed for instrumenting with rotary files (P=0.000). Conclusions Considering the comparable results in accuracy of root canal length determination and the considerably shorter instrumentation time in Root ZXII apex locator and rotary system, it may be suggested for pulpectomy in primary molar teeth. Key words:Rotary technique, conventional technique, pulpectomy, primary teeth. PMID:29302280

A smart rotary technique versus conventional pulpectomy for primary teeth: A randomized controlled clinical study.

PubMed

Mokhtari, Negar; Shirazi, Alireza-Sarraf; Ebrahimi, Masoumeh

2017-11-01

Techniques with adequate accuracy of working length determination along with shorter duration of treatment in pulpectomy procedure seems to be essential in pediatric dentistry. The aim of the present study was to evaluate the accuracy of root canal length measurement with Root ZX II apex locator and rotary system in pulpectomy of primary teeth. In this randomized control clinical trial complete pulpectomy was performed on 80 mandibular primary molars in 80, 4-6-year-old children. The study population was randomly divided into case and control groups. In control group conventional pulpectomy was performed and in the case group working length was determined by electronic apex locator Root ZXII and instrumented with Mtwo rotary files. Statistical evaluation was performed using Mann-Whitney and Chi-Square tests ( P <0.05). There were no significant differences between electronic apex locator Root ZXII and conventional method in accuracy of root canal length determination. However significantly less time was needed for instrumenting with rotary files ( P =0.000). Considering the comparable results in accuracy of root canal length determination and the considerably shorter instrumentation time in Root ZXII apex locator and rotary system, it may be suggested for pulpectomy in primary molar teeth. Key words: Rotary technique, conventional technique, pulpectomy, primary teeth.

Assessment of the antidandruff activity of a new shampoo: a randomized, double-blind, controlled study by clinical and instrumental evaluations.

PubMed

Sparavigna, Adele; Setaro, Michele; Caserini, Maurizio; Bulgheroni, Anna

2013-01-01

The aim of this randomized, double-blind, controlled study was to evaluate the antidandruff activity exerted by a new shampoo on patients affected by dandruff and/or mild seborrheic dermatitis by means of both D-squame technique coupled with image analysis and clinical assessments. Thirty-four patients were enrolled and 1:1 randomly assigned to either a test shampoo or a comparative shampoo group. Treatment schedule was twice a week for 4 weeks. The D-squame technique was shown to be able to objectively record variations in scalp desquamation both between test and comparative groups and within the same group over time. The results obtained with this instrumental approach showed a statistically significant reduction by 52% vs baseline after 2 weeks of treatment. There was an even greater reduction after 4 weeks (-66%). This reduction was statistically significant compared with the comparative group at the same time points. The analysis of all the other parameters (except Wood's lamp) confirmed the superiority of the test vs the comparative shampoo. The test shampoo proved to be safe, well tolerated, and accepted by the patients for cosmetic acceptability and efficacy. The study confirmed the antidandruff efficacy of the test shampoo and its superiority vs the comparative shampoo.

Caring letters for suicide prevention: implementation of a multi-site randomized clinical trial in the U.S. military and Veteran Affairs healthcare systems.

PubMed

Luxton, David D; Thomas, Elissa K; Chipps, Joan; Relova, Rona M; Brown, Daphne; McLay, Robert; Lee, Tina T; Nakama, Helenna; Smolenski, Derek J

2014-03-01

Caring letters is a suicide prevention intervention that entails the sending of brief messages that espouse caring concern to patients following discharge from treatment. First tested more than four decades ago, this intervention is one of the only interventions shown in a randomized controlled trial to reduce suicide mortality rates. Due to elevated suicide risk among patients following psychiatric hospitalization and the steady increase in suicide rates among the U.S. military personnel, it is imperative to test interventions that may help prevent suicide among high-risk military personnel and veterans. This paper describes the design, methods, study protocol, and regulatory implementation processes for a multi-site randomized controlled trial that aims to evaluate the effectiveness of a caring emails intervention for suicide prevention in the military and VA healthcare systems. The primary outcome is suicide mortality rates to be determined 24 months post-discharge from index hospital stay. Healthcare re-utilization rates will also be evaluated and comprehensive data will be collected regarding suicide risk factors. Recommendations for navigating the military and VA research regulatory processes and implementing a multi-site clinical trial at military and VA hospitals are discussed. Published by Elsevier Inc.

Topical Botulinum Toxin Type A Liposomal Cream for Primary Axillary Hyperhidrosis: A Double-Blind, Randomized, Split-Site, Vehicle-Controlled Study.

PubMed

Lueangarun, Suparuj; Sermsilp, Chairat; Tempark, Therdpong

2018-04-13

Despite its effectiveness in treating primary axillary hyperhidrosis (PAH), topical botulinum toxin type A (BTX-A) is highly resistant to transdermal absorption. Topical BTX-A liposomal cream is recommended as a novel, noninvasive modality to enhance skin penetration. To evaluate the efficacy and safety of topical BTX-A liposomal cream in comparison with liposomal vehicle cream alone in the treatment of PAH. A prospective, randomized, double-blinded, split-site study was conducted in 20 subjects, aged 18 to 50 years, all of whom had symmetrical axillary sweating with Hyperhidrosis Disease Severity Scale scores between 2 to 4. All subjects were double-blinded to treatment regimens and randomly given 2 bottles, one containing topical BTX-A liposomal cream and one containing the vehicle cream without BTX-A, to be applied consistently to the same axilla nightly for 7 consecutive days. Clinical improvement and adverse reactions were evaluated at every follow-up visit. Axillary skin treated with topical BTX-A demonstrated superior sweat reduction and patient satisfaction to vehicle cream-treated axillary skin, with clinical and statistical significance, at baseline, weeks 2, 4, 6, and 8 of follow-up, without adverse effects. Topical BTX-A liposomal cream pharmaceutically enhances drug delivery, is painless, cost-effective, and overall an innovative treatment of PAH.

Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial.

PubMed

da Silva, Mariana Moreira; Albertini, Regiane; Leal-Junior, Ernesto Cesar Pinto; de Tarso Camillo de Carvalho, Paulo; Silva, José Antonio; Bussadori, Sandra Kalil; de Oliveira, Luis Vicente Franco; Casarin, Cezar Augusto Souza; Andrade, Erinaldo Luiz; Bocalini, Danilo Sales; Serra, Andrey Jorge

2015-06-04

Fibromyalgia (FM) is a syndrome most prevalent in women, in whom it is characterized mainly by chronic pain. An important issue is that many patients with FM are reported to have temporomandibular dysfunction (TMD), and the coexistence of these pathologies generates a clinical outcome of high complexity. The literature is unclear regarding an effective therapy for reducing pain in patients with both comorbidities. Exercise training and phototherapy (low-level laser therapy with light-emitting diode) are two of the approaches used to treat pain. Thus, the aim of this study is to assess the potential role of exercise training plus phototherapy in reducing chronic pain in women with FM and TMD. A further aim is to determine whether the interventions can improve quality of life and modulate endogenous serotonin. A randomized controlled clinical trial will be conducted. It will involve 60 women ≥ 35 years of age with a diagnosis of FM and TMD. After recruitment, patients will be randomly allocated to one of four groups: a control group (no intervention), a group that will receive a phototherapy intervention (PHO), a group that will be prescribed muscle-stretching, aerobic, and facial exercises (EXT), or a group that will receive phototherapy plus exercise interventions (PHO + EXT). The trial will last 10 weeks, and the following outcomes will be evaluated on two separate occasions (baseline and within 24 h after the last day of the protocol). Pain intensity will be analyzed using a visual analogue scale and the McGill Pain Questionnaire, and pain thresholds will be punctuated using a digital algometer. FM symptoms will be assessed using the Fibromyalgia Impact Questionnaire, and quality of life will be determined with the 36-item Short Form Health Survey. Serotonin levels will be evaluated in salivary samples using a competitive enzyme-linked immunosorbent assay. This is the first randomized controlled trial in which the role of phototherapy, exercise training, and a combination of these interventions will be evaluated for chronic pain in patients with FM and TMD. The results will offer valuable clinical evidence for objective assessment of the potential benefits and risks of procedures. ClinicalTrials.gov Identifier: NCT02279225. Registered 27 October 2014.

Immediate relief of herniated lumbar disc-related sciatica by ankle acupuncture: A study protocol for a randomized controlled clinical trial.

PubMed

Xiang, Anfeng; Xu, Mingshu; Liang, Yan; Wei, Jinzi; Liu, Sheng

2017-12-01

Around 90% of sciatica cases are due to a herniated intervertebral disc in the lumbar region. Ankle acupuncture (AA) has been reported to be effective in the treatment of acute nonspecific low back pain. This study aims to evaluate the efficacy of a single session of ankle acupuncture for disc-related sciatica. This will be a double-blinded, randomized controlled clinical trial. Patients diagnosed with disc-related sciatica will be randomly divided into 3 parallel groups. The treatment group (n = 30) will receive ankle acupuncture. The 2 control groups will either undergo traditional needle manipulation (n = 30) or sham acupuncture (n = 30) at the same point as the treatment group. The primary outcome will be pain intensity on a visual analog scale (VAS). The secondary outcomes will be paresthesia intensity on a VAS and the Abbreviated Acceptability Rating Profile (AAPR). The success of blinding will be evaluated, and the needle-induced sensation and adverse events will be recorded. All outcomes will be evaluated before, during, and after the treatment. This study will determine the immediate effect and specificity of ankle acupuncture for the treatment of disc-related sciatica. We anticipate that ankle acupuncture might be more effective than traditional needle manipulation or sham acupuncture. ChiCTR-IPR-15007127 (http://www.chictr.org.cn/showprojen.aspx?proj=11989). Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Long-term efficacy of in-office and at-home bleaching: a 2-year double-blind randomized clinical trial.

PubMed

Tay, Lidia Yileng; Kose, Carlos; Herrera, Daniel Rodrigo; Reis, Alessandra; Loguercio, Alessandro Dourado

2012-08-01

This parallel, double-blind randomized clinical trial evaluated the 2-year bleaching efficacy and sensitivity produced by at-home (AH) and in-office (IO) bleaching therapies. 60 participants with tooth color darker than C2, without restorations in the anterior dentition and older than 18 years old, were randomly allocated into two groups to receive either IO with 35% hydrogen peroxide or AH with 16% carbamide peroxide. Color was recorded at baseline (BA); 1-week (1W); end of the treatment (ET); and 2 years (2Y) after bleaching, using the Vita Classical shade guide. The perception of TS was recorded on a 0-4 scale during and 2Y after bleaching. The variation in shade guide units (deltaSGU) from BA vs. 1W was compared to deltaSGU from BA vs. 2Y using paired t-test. The percentage of subjects who reported TS was evaluated by Fisher's exact test. The intensity of TS was evaluated by a Mann-Whitney test (alpha=0.05). Both bleaching techniques demonstrated equivalent and significant tooth color shade lightening. No significant color rebound occurred after 2Y for both techniques (P= 0.77 and 0.87, for AH and IO respectively). The absolute risk of TS was similar for IO and AH (P= 0.12), however the intensity of TS was significantly higher for IO (P= 0.001). No subjects reported sensitivity after 2Y.

The Japanese Guidelines for Breast Cancer Screening.

PubMed

Hamashima, Chisato; Hamashima C, Chisato; Hattori, Masakazu; Honjo, Satoshi; Kasahara, Yoshio; Katayama, Takafumi; Nakai, Masahiro; Nakayama, Tomio; Morita, Takako; Ohta, Koji; Ohnuki, Koji; Sagawa, Motoyasu; Saito, Hiroshi; Sasaki, Seiju; Shimada, Tomoyuki; Sobue, Tomotaka; Suto, Akihiko

2016-05-01

The incidence of breast cancer has progressively increased, making it the leading cause of cancer deaths in Japan. Breast cancer accounts for 20.4% of all new cancers with a reported age-standardized rate of 63.6 per 100 000 women. The Japanese guidelines for breast cancer screening were developed based on a previously established method. The efficacies of mammography with and without clinical breast examination, clinical breast examination and ultrasonography with and without mammography were evaluated. Based on the balance of the benefits and harms, recommendations for population-based and opportunistic screenings were formulated. Five randomized controlled trials of mammographic screening without clinical breast examination were identified for mortality reduction from breast cancer. The overall relative risk for women aged 40-74 years was 0.75 (95% CI: 0.67-0.83). Three randomized controlled trials of mammographic screening with clinical breast examination served as eligible evidence for mortality reduction from breast cancer. The overall relative risk for women aged 40-64 years was 0.87 (95% confidence interval: 0.77-0.98). The major harms of mammographic screening were radiation exposure, false-positive cases and overdiagnosis. Although two case-control studies evaluating mortality reduction from breast cancer were found for clinical breast examination, there was no study assessing the effectiveness of ultrasonography for breast cancer screening. Mammographic screening without clinical breast examination for women aged 40-74 years and with clinical breast examination for women aged 40-64 years is recommended for population-based and opportunistic screenings. Clinical breast examination and ultrasonography are not recommended for population-based screening because of insufficient evidence regarding their effectiveness. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A nurse-delivered, clinic-based intervention to address intimate partner violence among low-income women in Mexico City: findings from a cluster randomized controlled trial.

PubMed

Gupta, Jhumka; Falb, Kathryn L; Ponta, Oriana; Xuan, Ziming; Campos, Paola Abril; Gomez, Annabel Arellano; Valades, Jimena; Cariño, Gisele; Olavarrieta, Claudia Diaz

2017-07-12

Rigorous evaluations of health sector interventions addressing intimate partner violence (IPV) in low- and middle-income countries are lacking. We aimed to assess whether an enhanced nurse-delivered intervention would reduce IPV and improve levels of safety planning behaviors, use of community resources, reproductive coercion, and mental quality of life. We randomized 42 public health clinics in Mexico City to treatment or control arms. In treatment clinics, women received the nurse-delivered session (IPV screening, supportive referrals, health/safety risk assessments) at baseline (T1), and a booster counselling session after 3 months (T2). In control clinics, women received screening and a referral card from nurses. Surveys were conducted at T1, T2, and T3 (15 months from baseline). Our main outcome was past-year physical and sexual IPV. Intent-to-treat analyses were conducted via three-level random intercepts models to evaluate the interaction term for treatment status by time. Between April and October 2013, 950 women (480 in control clinics, 470 in treatment clinics) with recent IPV experiences enrolled in the study. While reductions in IPV were observed for both women enrolled in treatment (OR, 0.40; 95% CI, 0.28-0.55; P < 0.01) and control (OR, 0.51; 95% CI, 0.36-0.72; P < 0.01) clinics at T3 (July to December 2014), no significant treatment effects were observed (OR, 0.78; 95% CI, 0.49-1.24; P = 0.30). At T2 (July to December 2013), women in treatment clinics reported significant improvements, compared to women in control clinics, in mental quality of life (β, 1.45; 95% CI, 0.14-2.75; P = 0.03) and safety planning behaviors (β, 0.41; 95% CI, 0.02-0.79; P = 0.04). While reductions in IPV levels were seen among women in both treatment and control clinics, the enhanced nurse intervention was no more effective in reducing IPV. The enhanced nursing intervention may offer short-term improvements in addressing safety planning and mental quality of life. Nurses can play a supportive role in assisting women with IPV experiences. Clinicaltrials.gov ( NCT01661504 ). Registration Date: August 2, 2012.

[Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

PubMed

Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

2016-11-01

To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles such as blindness, randomization and control in RCTs, while requiring reporting in accordance with international standards. Copyright© by the Chinese Pharmaceutical Association.

Evaluating the statistical methodology of randomized trials on dentin hypersensitivity management.

PubMed

Matranga, Domenica; Matera, Federico; Pizzo, Giuseppe

2017-12-27

The present study aimed to evaluate the characteristics and quality of statistical methodology used in clinical studies on dentin hypersensitivity management. An electronic search was performed for data published from 2009 to 2014 by using PubMed, Ovid/MEDLINE, and Cochrane Library databases. The primary search terms were used in combination. Eligibility criteria included randomized clinical trials that evaluated the efficacy of desensitizing agents in terms of reducing dentin hypersensitivity. A total of 40 studies were considered eligible for assessment of quality statistical methodology. The four main concerns identified were i) use of nonparametric tests in the presence of large samples, coupled with lack of information about normality and equality of variances of the response; ii) lack of P-value adjustment for multiple comparisons; iii) failure to account for interactions between treatment and follow-up time; and iv) no information about the number of teeth examined per patient and the consequent lack of cluster-specific approach in data analysis. Owing to these concerns, statistical methodology was judged as inappropriate in 77.1% of the 35 studies that used parametric methods. Additional studies with appropriate statistical analysis are required to obtain appropriate assessment of the efficacy of desensitizing agents.

Safety, tolerability, and immunogenicity of the novel antituberculous vaccine RUTI: randomized, placebo-controlled phase II clinical trial in patients with latent tuberculosis infection.

PubMed

Nell, Andre S; D'lom, Eva; Bouic, Patrick; Sabaté, Montserrat; Bosser, Ramon; Picas, Jordi; Amat, Mercè; Churchyard, Gavin; Cardona, Pere-Joan

2014-01-01

To evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 µg) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection. Double-blind, randomized, placebo-controlled Phase II Clinical Trial (95 patients randomized). Three different RUTI doses and placebo were tested, randomized both in HIV-positive (n = 47) and HIV-negative subjects (n = 48), after completion of one month isoniazid (INH) pre-vaccination. Each subject received two vaccine administrations, 28 Days apart. Five patients withdrew and 90 patients completed the study. Assessment of safety showed no deaths during study. Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized; causality was assessed as very likely and by the end of the study the outcome had resolved. All the patients except 5 (21%) patients of the placebo group (3 HIV+ and 2 HIV-) reported at least one adverse event (AE) during the study. The most frequently occurring AEs among RUTI recipients were (% in HIV+/-): injection site reactions [erythema (91/92), induration (94/92), local nodules (46/25), local pain (66/75), sterile abscess (6/6), swelling (74/83), ulcer (20/11), headache (17/22) and nasopharyngitis (20/5)]. These events were mostly mild and well tolerated. Overall, a polyantigenic response was observed, which differed by HIV- status. The best polyantigenic response was obtained when administrating 25 µg RUTI, especially in HIV-positive subjects which was not increased after the second inoculation. This Phase II clinical trial demonstrates reasonable tolerability of RUTI. The immunogenicity profile of RUTI vaccine in LTBI subjects, even being variable among groups, allows us considering one single injection of one of the highest doses in future trials, preceded by an extended safety clinical phase. ClinicalTrials.gov NCT01136161.

Clamp-Crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607)

PubMed Central

2011-01-01

Background Hepatic resection is still associated with significant morbidity. Although the period of parenchymal transection presents a crucial step during the operation, uncertainty persists regarding the optimal technique of transection. It was the aim of the present randomized controlled trial to evaluate the efficacy and safety of hepatic resection using the technique of stapler hepatectomy compared to the simple clamp-crushing technique. Methods/Design The CRUNSH Trial is a prospective randomized controlled single-center trial with a two-group parallel design. Patients scheduled for elective hepatic resection without extrahepatic resection at the Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg are enrolled into the trial and randomized intraoperatively to hepatic resection by the clamp-crushing technique and stapler hepatectomy, respectively. The primary endpoint is total intraoperative blood loss. A set of general and surgical variables are documented as secondary endpoints. Patients and outcome-assessors are blinded for the treatment intervention. Discussion The CRUNSH Trial is the first randomized controlled trial to evaluate efficacy and safety of stapler hepatectomy compared to the clamp-crushing technique for parenchymal transection during elective hepatic resection. Trial Registration ClinicalTrials.gov: NCT01049607 PMID:21888669

Rating the raters: assessing the quality of Hamilton rating scale for depression clinical interviews in two industry-sponsored clinical drug trials.

PubMed

Engelhardt, Nina; Feiger, Alan D; Cogger, Kenneth O; Sikich, Dawn; DeBrota, David J; Lipsitz, Joshua D; Kobak, Kenneth A; Evans, Kenneth R; Potter, William Z

2006-02-01

The quality of clinical interviews conducted in industry-sponsored clinical drug trials is an important but frequently overlooked variable that may influence the outcome of a study. We evaluated the quality of Hamilton Rating Scale for Depression (HAM-D) clinical interviews performed at baseline in 2 similar multicenter, randomized, placebo-controlled depression trials sponsored by 2 pharmaceutical companies. A total of 104 audiotaped HAM-D clinical interviews were evaluated by a blinded expert reviewer for interview quality using the Rater Applied Performance Scale (RAPS). The RAPS assesses adherence to a structured interview guide, clarification of and follow-up to patient responses, neutrality, rapport, and adequacy of information obtained. HAM-D interviews were brief and cursory and the quality of interviews was below what would be expected in a clinical drug trial. Thirty-nine percent of the interviews were conducted in 10 minutes or less, and most interviews were rated fair or unsatisfactory on most RAPS dimensions. Results from our small sample illustrate that the clinical interview skills of raters who administered the HAM-D were below what many would consider acceptable. Evaluation and training of clinical interview skills should be considered as part of a rater training program.

Comparison of Clinical Results, Second-Look Arthroscopic Findings, and MRI Findings Between the Transportal and Outside-In Techniques for Double-Bundle Anatomic Anterior Cruciate Ligament Reconstruction: A Prospective, Randomized Controlled Trial With a Minimum 2-Year Follow-up.

PubMed

Kim, Jae Gyoon; Kang, Seung Hoon; Kim, Jun Ho; Lim, Chae Ouk; Wang, Joon Ho

2018-03-01

Although image analysis has shown that the outside-in (OI) technique is associated with different femoral tunnel geometry than the transportal (TP) technique in anatomic anterior cruciate ligament (ACL) reconstruction, it is not known whether clinical results differ between the 2 techniques. To compare clinical results, second-look arthroscopic findings, and magnetic resonance imaging (MRI) findings between the TP and OI techniques in anatomic double-bundle (DB) ACL reconstruction. Randomized controlled trial; Level of evidence, 2. From November 2010 to March 2013, 128 patients were enrolled in this study and were randomly assigned to either the TP group (64 patients) or the OI group (64 patients), and DB ACL reconstructions were performed. At the minimum 2-year follow-up (34.9 ± 10.9 months), 111 patients (86.7%) were evaluated with multiple clinical scores and stability tests (KT-2000 arthrometer, Lachman test, and pivot-shift test). Ninety-three knees were evaluated for graft continuity, graft tension, and synovialization by use of second-look arthroscopy. Seventy-eight knees were evaluated on MRI for graft continuity, femoral graft tunnel healing, and graft signal/noise quotient (SNQ). The primary outcome was KT-2000 arthrometer results. Results were compared between the TP and OI groups. No significant differences were found between the 2 groups in terms of KT-2000 arthrometer results, which was the primary outcome, and other clinical results, with the exception of the postoperative functional test of International Knee Documentation Committee (IKDC) objective score. The ratio of grade A and B on the postoperative functional test of IKDC objective score was significantly larger for the OI group (51/58) than the TP group (36/53) ( P = .005). The second-look arthroscopic findings were not significantly different between the 2 groups in either bundle ( P > .05). In addition, MRI findings did not differ significantly between the 2 groups ( P > .05). With the exception of the functional test of IKDC objective score, we found that clinical results, second-look arthroscopic findings, and MRI findings did not differ significantly between the OI and TP techniques for anatomic ACL reconstruction, although femoral tunnel geometries differed significantly between the 2 techniques.

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

PubMed

Wang, Shengjun; Jiang, Hongli; Yu, Qin; She, Bin; Mao, Bing

2017-01-05

The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, based on the theory of traditional Chinese medicine (TCM), with the objective of evaluating the efficacy and safety of Lian-Ju-Gan-Mao capsules (LJGMC), a Chinese patent medicine, compared with placebo in patients suffering from the common cold with wind-heat syndrome (CCWHS). This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. A total of 240 patients will be recruited and randomly assigned to a high-dose group, medium-dose group, low-dose group, and placebo-matched group in a 1:1:1:1 ratio. The treatment course is 3 consecutive days, with a 5-day follow-up. The primary outcome is time to all symptoms' clearance. Secondary outcomes include time to the disappearance of primary symptoms and each secondary symptom, time to fever relief, time to fever clearance, and change in TCM symptom and sign scores. This trial is a well-designed study according to principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high-quality evidence on the efficacy and safety of LJGMC in treating CCWHS and help to optimize the dose for the next phase III clinical trial. Moreover, the protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM. Chinese Clinical Trial Registry, ChiCTR-IPR-15006504 . Registered on 4 June 2015.

Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

PubMed

Coca, Steven G; Zabetian, Azadeh; Ferket, Bart S; Zhou, Jing; Testani, Jeffrey M; Garg, Amit X; Parikh, Chirag R

2016-08-01

Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. Copyright © 2016 by the American Society of Nephrology.

Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence.

PubMed

Dimidjian, Sona; Goodman, Sherryl H; Felder, Jennifer N; Gallop, Robert; Brown, Amanda P; Beck, Arne

2016-02-01

Clinical decision-making regarding the prevention of depression is complex for pregnant women with histories of depression and their health care providers. Pregnant women with histories of depression report preference for nonpharmacological care, but few evidence-based options exist. Mindfulness-based cognitive therapy has strong evidence in the prevention of depressive relapse/recurrence among general populations and indications of promise as adapted for perinatal depression (MBCT-PD). With a pilot randomized clinical trial, our aim was to evaluate treatment acceptability and efficacy of MBCT-PD relative to treatment as usual (TAU). Pregnant adult women with depression histories were recruited from obstetric clinics at 2 sites and randomized to MBCT-PD (N = 43) or TAU (N = 43). Treatment acceptability was measured by assessing completion of sessions, at-home practice, and satisfaction. Clinical outcomes were interview-based depression relapse/recurrence status and self-reported depressive symptoms through 6 months postpartum. Consistent with predictions, MBCT-PD for at-risk pregnant women was acceptable based on rates of completion of sessions and at-home practice assignments, and satisfaction with services was significantly higher for MBCT-PD than TAU. Moreover, at-risk women randomly assigned to MBCT-PD reported significantly improved depressive outcomes compared with participants receiving TAU, including significantly lower rates of depressive relapse/recurrence and lower depressive symptom severity during the course of the study. MBCT-PD is an acceptable and clinically beneficial program for pregnant women with histories of depression; teaching the skills and practices of mindfulness meditation and cognitive-behavioral therapy during pregnancy may help to reduce the risk of depression during an important transition in many women's lives. (c) 2016 APA, all rights reserved).

The short- and long-term outcomes of percutaneous intervention with drug-eluting stent vs bare-metal stent in saphenous vein graft disease: An updated meta-analysis of all randomized clinical trials.

PubMed

Kheiri, Babikir; Osman, Mohammed; Abdalla, Ahmed; Ahmed, Sahar; Bachuwa, Ghassan; Hassan, Mustafa

2018-05-11

The use of drug-eluting stents (DES) vs bare-metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta-analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short- and long-term clinical outcomes of the following: all-cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target-vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short-term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35-0.91, P = 0.02; OR: 0.43, 95% CI: 0.19-0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22-0.95, P = 0.04, respectively). However, there were no different outcomes for all-cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long-term follow-up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all-cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short-term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long-term follow-up. © 2018 Wiley Periodicals, Inc.

High In Vitro Activity of the Novel Spiropyrimidinetrione AZD0914, a DNA Gyrase Inhibitor, against Multidrug-Resistant Neisseria gonorrhoeae Isolates Suggests a New Effective Option for Oral Treatment of Gonorrhea

PubMed Central

Jacobsson, Susanne; Golparian, Daniel; Alm, Richard A.; Huband, Michael; Mueller, John; Jensen, Jorgen Skov; Ohnishi, Makoto

2014-01-01

We evaluated the activity of the novel spiropyrimidinetrione AZD0914 (DNA gyrase inhibitor) against clinical gonococcal isolates and international reference strains (n = 250), including strains with diverse multidrug resistance and extensive drug resistance. The AZD0914 MICs were substantially lower than those of most other currently or previously recommended antimicrobials. AZD0914 should be further evaluated, including in vitro selection, in vivo emergence and mechanisms of resistance, pharmacokinetics/pharmacodynamics in humans, optimal dosing, and performance, in appropriate randomized and controlled clinical trials. PMID:24982070

Evaluation of Insomrid Tablet and Shirodhara in the management of Anidra (Insomnia).

PubMed

Pokharel, Sanjay; Sharma, Ajay Kumar

2010-01-01

The study was conducted in 30 clinically diagnosed patients of Anidra (Insomnia) with an objective of clinical evaluation of the efficacy of Shirodhara and Tab. Insomrid (proposed herbal formulation) in the management of Anidra (Insomnia). These patients were randomly divided into three groups of 10 patients each. In was observed that the patients of Group III treated with Tab. Insomrid and Shirodhara with milk showed highly significant improvements, whereas the Group II treated with Shirodhara and Group I treated with Tab. Insomrid also showed significant improvements. No adverse effects were noted in any of the patients during the trial period.

Evaluation of Insomrid Tablet and Shirodhara in the management of Anidra (Insomnia)

PubMed Central

Pokharel, Sanjay; Sharma, Ajay Kumar

2010-01-01

The study was conducted in 30 clinically diagnosed patients of Anidra (Insomnia) with an objective of clinical evaluation of the efficacy of Shirodhara and Tab. Insomrid (proposed herbal formulation) in the management of Anidra (Insomnia). These patients were randomly divided into three groups of 10 patients each. In was observed that the patients of Group III treated with Tab. Insomrid and Shirodhara with milk showed highly significant improvements, whereas the Group II treated with Shirodhara and Group I treated with Tab. Insomrid also showed significant improvements. No adverse effects were noted in any of the patients during the trial period. PMID:22131683

Clinical Application of Mesenchymal Stem Cells and Novel Supportive Therapies for Oral Bone Regeneration

PubMed Central

O'Valle, Francisco; Lanis, Alejandro; Dohan Ehrenfest, David M.; Wang, Hom-Lay; Galindo-Moreno, Pablo

2015-01-01

Bone regeneration is often needed prior to dental implant treatment due to the lack of adequate quantity and quality of the bone after infectious diseases, trauma, tumor, or congenital conditions. In these situations, cell transplantation technologies may help to overcome the limitations of autografts, xenografts, allografts, and alloplastic materials. A database search was conducted to include human clinical trials (randomized or controlled) and case reports/series describing the clinical use of mesenchymal stem cells (MSCs) in the oral cavity for bone regeneration only specifically excluding periodontal regeneration. Additionally, novel advances in related technologies are also described. 190 records were identified. 51 articles were selected for full-text assessment, and only 28 met the inclusion criteria: 9 case series, 10 case reports, and 9 randomized controlled clinical trials. Collectively, they evaluate the use of MSCs in a total of 290 patients in 342 interventions. The current published literature is very diverse in methodology and measurement of outcomes. Moreover, the clinical significance is limited. Therefore, the use of these techniques should be further studied in more challenging clinical scenarios with well-designed and standardized RCTs, potentially in combination with new scaffolding techniques and bioactive molecules to improve the final outcomes. PMID:26064899

A double-blind randomized placebo-controlled clinical trial of squalamine ointment for tinea capitis treatment.

PubMed

Coulibaly, Oumar; Thera, Mahamadou A; Koné, Abdoulaye K; Siaka, Goïta; Traoré, Pierre; Djimdé, Abdoulaye A; Brunel, Jean-Michel; Gaudart, Jean; Piarroux, Renaud; Doumbo, Ogobara K; Ranque, Stéphane

2015-04-01

Novel treatments against for tinea capitis are needed, and the natural aminosterol squalamine is a potential topical antidermatophyte drug candidate. This phase II randomized double-blind placebo-controlled clinical trial aimed at testing the efficacy and safety of a three-week squalamine ointment regimen for the treatment of tinea capitis. Males aged 6-15 years presenting with tinea capitis were treated with either topical squalamine ointment or placebo for 3 weeks. The primary endpoint was complete clinical cure. The secondary endpoints were the occurrence of local and/or systemic adverse events, mycological cure, and partial clinical response. Prospective follow-up of clinical adverse events was performed daily. Five patients were treated with 1% squalamine ointment and 15 with placebo. No complete cure was observed. No clinical or biological adverse event was recorded. A significantly (p = 0.03) better hair-growth score, indicating a partial clinical improvement of the tinea capitis lesion, was observed in the patients treated with squalamine compared to those treated with placebo. This three-week squalamine ointment regimen was well tolerated and showed an encouraging partial clinical activity for the treatment of tinea capitis. Further studies are needed to evaluate the efficacy of topical squalamine alone against tinea corporis or in combination with a systemic antidermatophyte drug against tinea capitis.

Access to orphan drugs despite poor quality of clinical evidence

PubMed Central

Dupont, Alain G; Van Wilder, Philippe B

2011-01-01

AIM We analysed the Belgian reimbursement decisions of orphan drugs as compared with those of innovative drugs for more common but equally severe diseases, with special emphasis on the quality of clinical evidence. METHODS Using the National Health Insurance Agency administrative database, we evaluated all submitted orphan drug files between 2002 and 2007. A quality analysis of the clinical evidence in the orphan reimbursement files was performed. The evaluation reports of the French ‘Haute Autorité de Santé’, including the five-point scale parameter ‘Service Médical Rendu (SMR), were examined to compare disease severity. Chi-squared tests (at P < 0.05 significance level) were used to compare the outcome of the reimbursement decisions between orphan and non-orphan innovative medicines. RESULTS Twenty-five files of orphan drugs and 117 files of non-orphan drugs were evaluated. Twenty-two of 25 (88%) submissions of orphan drugs were granted reimbursement as opposed to 74 of the 117 (63%) non-orphan innovative medicines (P = 0.02). Only 52% of the 25 orphan drug files included a randomized controlled trial as opposed to 84% in a random control sample of 25 non-orphan innovative submissions (P < 0.01). The duration of drug exposure was in most cases far too short in relation to the natural history of the disease. CONCLUSIONS Orphan drug designation predicts reimbursement despite poor quality of clinical evidence. The evidence gap at market authorization should be reduced by post-marketing programmes, in which the centralized regulatory and the local reimbursement authorities collaborate in an efficient way across the European Union member states. PMID:21395641

Essays on Child Development in Developing Countries

ERIC Educational Resources Information Center

Humpage, Sarah Davidson

2013-01-01

This dissertation presents the results of three field experiments implemented to evaluate the effectiveness of strategies to improve the health or education of children in developing countries. In Guatemala, community health workers at randomly selected clinics were given patient tracking lists to improve their ability to remind parents when their…

Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A treatment

USDA-ARS?s Scientific Manuscript database

We sought to determine whether lutein supplementation will slow visual function decline in patients with retinitis pigmentosa receiving vitamin A. DESIGN: Randomized, controlled, double-masked trial of 225 nonsmoking patients, aged 18 to 60 years, evaluated over a 4-year interval. Patients received ...

Associations between ankle-brachial index and cognitive function: results from the Lifestyle Interventions and Independence for Elders trial

USDA-ARS?s Scientific Manuscript database

OBJECTIVE: The objective of this study was to evaluate cross-sectional and longitudinal associations between ankle-brachial index (ABI) and indicators of cognitive function. DESIGN: Randomized clinical trial (Lifestyle Interventions and Independence for Elders Trial). SETTING: Eight US academic ce...

A Randomized Controlled Trial of Consensus-Based Child Abuse Case Management

ERIC Educational Resources Information Center

Goldbeck, L.; Laib-Koehnemund, A.; Fegert, J. M.

2007-01-01

Objective: This study evaluates the effects of expert-assisted child abuse and neglect case management in the German child welfare and healthcare system as perceived by the case workers themselves. Methods: Case workers with different professions (social workers, counselors, clinic-based and office-based psychotherapists, and physicians)…

Antioxidants intake and dry eye syndrome: a crossover, placebo-controlled, randomized trial.

PubMed

Drouault-Holowacz, Sophie; Bieuvelet, Séverine; Burckel, André; Rigal, Danièle; Dubray, Claude; Lichon, Jean-Louis; Bringer, Paul; Pilon, Francois; Chiambaretta, Frédéric

2009-01-01

To assess whether an orally administered antioxidant dietary supplement could improve the objective clinical signs and alleviate the subjective symptoms of dry eye syndrome. Twenty-four subjects diagnosed with dry eye syndrome were randomized in a crossover, double-blind, controlled, randomized study to receive a placebo or an antioxidants combination (Oxybiane) for 12 weeks. In all subjects, break-up time (BUT) test, Schirmer test, ocular symptoms (sore eyes, burning, itching, sensation of foreign object in the eye, photophobia, sticky eyes, and redness), visual comfort, and general well-being were evaluated weekly. After 12 weeks of supplementation with Oxybiane, both the BUT scores (27.3%+/-8.4% with Oxybiane versus 3.61%+/-4.3% with the placebo, p=0.017) and the Schirmer scores (26.9%+/-14.2% with Oxybiane versus -4.7%+/-3.4% with the placebo, p=0.037) were significantly increased. A significantly improvement was also observed considering subjective clinical symptoms such as burning (p=0.031), itching (p=0.027), sensation of foreign body in eye (p=0.030), and redness (p=0.043). CONCLUSIONS. Supplementation with oral antioxidants can improve both tear stability and quantity but also subjective clinical signs.

Evaluating real-time internet therapy and online self-help for problematic alcohol consumers: a three-arm RCT protocol.

PubMed

Blankers, Matthijs; Koeter, Maarten; Schippers, Gerard M

2009-01-14

Only a minority of all alcohol- and drug abusers is receiving professional care. In an attempt to narrow this treatment gap, treatment facilities experiment with online healthcare. Therefore, it is important to test the (cost-)effectiveness of online health interventions in a randomized clinical trial. This paper presents the protocol of a three-arm randomized clinical trial to test the (cost-) effectiveness of online treatment for problem drinkers. Self-help online, therapy online and a waiting list are tested against each other. Primary outcome is change in alcohol consumption. Secondary outcome measures include quality of life and working ability. Incremental cost-effectiveness ratios for self-help online alcohol and therapy online alcohol will be calculated. The predictive validity of participant characteristics on treatment adherence and outcome will be explored. To our best knowledge, this randomized clinical trial will be the first to test the effectiveness of therapy online against both self-help online and a waiting-list. It will provide evidence on (cost-) effectiveness of online treatment for problem drinkers and investigate outcome predictors. This trial is registered in the Dutch Trialregister (Cochrane Collaboration) and traceable as NTR-TC1155.

Overcoming barriers to HPV vaccination: A randomized clinical trial of a culturally-tailored, media intervention among African American girls.

PubMed

DiClemente, Ralph J; Murray, Colleen Crittenden; Graham, Tracie; Still, Julia

2015-01-01

Although genital HPV is the most prevalent STI in the US, rates of vaccination uptake among high-risk subgroups remain low. Investigations of vaccine compliance have mainly targeted mother-daughter dyads, which in some settings may prove difficult. This study examines an innovative culturally tailored, computer-delivered media-based strategy to promote HPV vaccine uptake. Data, inclusive of sociodemographics, sexual behaviors, knowledge, attitudes, and beliefs about HPV and vaccination were collected via ACASI from 216 African American adolescent females (ages 14-18 years) seeking services in family planning and STI public health clinics in metropolitan Atlanta. Data were obtained prior to randomization and participation in an interactive media-based intervention designed to increase HPV vaccination uptake. Medical record abstraction was conducted 7 month post-randomization to assess initial vaccine uptake and compliance. Participants in the intervention were more compliant to vaccination relative to a placebo comparison condition (26 doses vs. Seventeen doses; p=0.12). However, vaccination series initiation and completion were lower than the national average. Thorough evaluation is needed to better understand factors facilitating HPV vaccine uptake and compliance, particularly perceived susceptibility and the influence of the patient-provider encounter in a clinical setting.

Early initiation of beta blockade in heart failure: issues and evidence.

PubMed

Williams, Randall E

2005-09-01

Despite clinical trials demonstrating that inhibitors of the renin-angiotensin and sympathetic nervous systems can reduce the mortality and morbidity risk associated with heart failure, these drugs have remained underutilized in general clinical practice. In particular, many patients with heart failure due to left ventricular systolic dysfunction fail to receive beta blockers, although this class of drugs, as well as other antihypertensive agents such as angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, are recommended as part of routine heart failure therapy by national expert consensus guidelines. In-hospital initiation of beta-blocker therapy may improve long-term utilization by physicians and compliance by patients through obviating many of the misperceived dangers associated with beta blockade. The following review of the clinical trial data from the Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) trial, the Metoprolol Controlled-Release Randomized Intervention Trial in Heart Failure (MERIT-HF), the Cardiac Insufficiency Bisoprolol Study II (CIBIS-II), the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial, and the Initiation Management Predischarge Process for Assessment of Carvedilol Therapy for Heart Failure (IMPACT-HF) trial on the efficacy, safety, and tolerability of beta blockers indicates that early initiation can be safely achieved and can improve patient outcomes.

Follow-up of solar lentigo depigmentation with a retinaldehyde-based cream by clinical evaluation and calibrated colour imaging.

PubMed

Questel, E; Durbise, E; Bardy, A-L; Schmitt, A-M; Josse, G

2015-05-01

To assess an objective method evaluating the effects of a retinaldehyde-based cream (RA-cream) on solar lentigines; 29 women randomly applied RA-cream on lentigines of one hand and a control cream on the other, once daily for 3 months. A specific method enabling a reliable visualisation of the lesions was proposed, using high-magnification colour-calibrated camera imaging. Assessment was performed using clinical evaluation by Physician Global Assessment score and image analysis. Luminance determination on the numeric images was performed either on the basis of 5 independent expert's consensus borders or probability map analysis via an algorithm automatically detecting the pigmented area. Both image analysis methods showed a similar lightening of ΔL* = 2 after a 3-month treatment by RA-cream, in agreement with single-blind clinical evaluation. High-magnification colour-calibrated camera imaging combined with probability map analysis is a fast and precise method to follow lentigo depigmentation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Peer group reflection helps clinical teachers to critically reflect on their teaching.

PubMed

Boerboom, Tobias B B; Jaarsma, Debbie; Dolmans, Diana H J M; Scherpbier, Albert J J A; Mastenbroek, Nicole J J M; Van Beukelen, Peter

2011-01-01

Student evaluations can help clinical teachers to reflect on their teaching skills and find ways to improve their teaching. Studies have shown that the mere presentation of student evaluations is not a sufficient incentive for teachers to critically reflect on their teaching. We evaluated and compared the effectiveness of two feedback facilitation strategies that were identical except for a peer reflection meeting. In this study, 54 clinical teachers were randomly assigned to two feedback strategies. In one strategy, a peer reflection was added as an additional step. All teachers completed a questionnaire evaluating the strategy that they had experienced. We analysed the reflection reports and the evaluation questionnaire. Both strategies stimulated teachers to reflect on feedback and formulate alternative actions for their teaching practice. The teachers who had participated in the peer reflection meeting showed deeper critical reflection and more concrete plans to change their teaching. All feedback strategies were considered effective by the majority of the teachers. Strategies with student feedback and self-assessment stimulated reflection on teaching and helped clinical teachers to formulate plans for improvement. A peer reflection meeting seemed to enhance reflection quality. Further research should establish whether it can have lasting effects on teaching quality.

Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively

PubMed Central

Marzegalli, Maurizio; Landolina, Maurizio; Lunati, Maurizio; Perego, Giovanni B; Pappone, Alessia; Guenzati, Giuseppe; Campana, Carlo; Frigerio, Maria; Parati, Gianfranco; Curnis, Antonio; Colangelo, Irene; Valsecchi, Sergio

2009-01-01

Background Heart failure patients with implantable defibrillators (ICD) frequently visit the clinic for routine device monitoring. Moreover, in the case of clinical events, such as ICD shocks or alert notifications for changes in cardiac status or safety issues, they often visit the emergency department or the clinic for an unscheduled visit. These planned and unplanned visits place a great burden on healthcare providers. Internet-based remote device interrogation systems, which give physicians remote access to patients' data, are being proposed in order to reduce routine and interim visits and to detect and notify alert conditions earlier. Methods The EVOLVO study is a prospective, randomized, parallel, unblinded, multicenter clinical trial designed to compare remote ICD management with the current standard of care, in order to assess its ability to treat and triage patients more effectively. Two-hundred patients implanted with wireless-transmission-enabled ICD will be enrolled and randomized to receive either the Medtronic CareLink® monitor for remote transmission or the conventional method of in-person evaluations. The purpose of this manuscript is to describe the design of the trial. The results, which are to be presented separately, will characterize healthcare utilizations as a result of ICD follow-up by means of remote monitoring instead of conventional in-person evaluations. Trial registration ClinicalTrials.gov: NCT00873899 PMID:19538734

Is intracytoplasmic morphologically selected sperm injection (IMSI) beneficial in the first ART cycle? a multicentric randomized controlled trial.

PubMed

Leandri, R D; Gachet, A; Pfeffer, J; Celebi, C; Rives, N; Carre-Pigeon, F; Kulski, O; Mitchell, V; Parinaud, J

2013-09-01

Intracytoplasmic morphologically selected sperm injection (IMSI), by selecting spermatozoa at high magnification improves the outcome of intracytoplasmic sperm injection (ICSI) mainly after several failures. However, only few monocentric randomized studies are available and they do not analyse results as a function of sperm characteristics. In 255 couples attempting their first assisted reproductive technology (ART) attempt for male infertility (motile sperm count <1×10⁶ after sperm selection, but at least 3×10⁶ spermatozoa per ejaculate to allow a detailed analysis of sperm characteristics), a prospective randomized trial was performed to compare the clinical outcomes of IMSI and ICSI and to evaluate the influence of sperm characteristics on these outcomes. IMSI did not provide any significant improvement in the clinical outcomes compared with ICSI neither for implantation (24% vs. 23%), nor clinical pregnancy (31% vs. 33%) nor live birth rates (27% vs. 30%). Moreover, the results of IMSI were similar to the ICSI ones whatever the degree of sperm DNA fragmentation, nuclear immaturity and sperm morphology. These results show that IMSI instead of ICSI has no advantage in the first ART attempts. However, this does not rule out IMSI completely and more randomized trials must be performed especially regarding patients carrying severe teratozoospermia, or high sperm DNA fragmentation levels or having previous ICSI failures. © 2013 American Society of Andrology and European Academy of Andrology.

The efficacy of cetirizine hydrochloride on the pruritus of cats with atopic dermatitis: a randomized, double-blind, placebo-controlled, crossover study.

PubMed

Wildermuth, Kerstin; Zabel, Sonja; Rosychuk, Rod A W

2013-12-01

Various antihistamines have been used in the management of feline atopic dermatitis, with variable reported benefit. To date, there have been no randomized, double-blind, placebo-controlled, crossover clinical trials on the use of this drug class in cats. To evaluate the clinical efficacy of cetirizine hydrochloride for the control of pruritus and dermatitis in cats diagnosed with atopic dermatitis. In this randomized, double-blind, placebo-controlled crossover clinical trial, 21 client-owned cats diagnosed with mild to moderate nonseasonal atopic dermatitis were randomly assigned to two groups. Cats in each group received either 1 mg/kg cetirizine hydrochloride or placebo once daily per os for 28 days followed by a 14 day wash-out period. Treatments were then crossed over, and cats received placebo or cetirizine hydrochloride for another 28 days. Owners marked a pruritus severity scale before inclusion in the study and weekly throughout the entire study period. Lesions were scored by the clinician using a Canine Atopic Dermatitis Extent and Severity Index (CADESI)-03 modified for the cat before enrolment and at day 28 of each treatment. Nineteen cats completed the study. There were no statistically significant differences between treatment with cetirizine hydrochloride and placebo for modified CADESI-03 or pruritus scores. This study suggests that cetirizine hydrochloride cannot be recommended for the management of feline atopic dermatitis. © 2013 ESVD and ACVD.

[METHODS OF EVALUATION OF MUSCLE MASS: A SYSTEMATIC REVIEW OF RANDOMIZED CONTROLLED TRIALS].

PubMed

Moreira, Osvaldo Costa; de Oliveira, Cláudia Eliza Patrocínio; Candia-Luján, Ramón; Romero-Pérez, Ena Monserrat; de Paz Fernandez, José Antonio

2015-09-01

in recent years, research about muscle mass has gained popularity for their relationship to health. Thus precise measurement of muscle mass may have clinical application once may interfere with the diagnosis and prescription drug or drug treatment. to conduct a systematic review of the methods most used for evaluation of muscle mass in randomized controlled trials, with its advantages and disadvantages. we conducted a search of the data bases Pub- Med, Web of Science and Scopus, with words "muscle mass", "measurement", "assessment" and "evaluation", combined in this way: "muscle mass" AND (assessment OR measurement OR evaluation). 23 studies were recovered and analyzed, all in English. 69.56% only used a method for quantification of muscle mass; 69.57% used dual X-ray absorptiometry (DXA); in 45.46% the type of measure used was the body lean mass; and 51.61% chose the whole body as a site of measurement. in the randomized controlled trials analyzed the majority used just one method of assessment, with the DXA being the method most used, the body lean mass the measurement type most used and total body the most common site of measure. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.

PubMed

McClure, Erin A; Sonne, Susan C; Winhusen, Theresa; Carroll, Kathleen M; Ghitza, Udi E; McRae-Clark, Aimee L; Matthews, Abigail G; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G; Levin, Frances R; Weiss, Roger D; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J; Haynes, Louise; Brigham, Gregory S; Sparenborg, Steve; Hasson, Albert L; Gray, Kevin M

2014-11-01

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. Copyright © 2014 Elsevier Inc. All rights reserved.

Achieving Cannabis Cessation - Evaluating N-acetylcysteine Treatment (ACCENT): Design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network

PubMed Central

McClure, Erin A.; Sonne, Susan C.; Winhusen, Theresa; Carroll, Kathleen M.; Ghitza, Udi E.; McRae-Clark, Aimee L.; Matthews, Abigail G.; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G.; Levin, Frances R.; Weiss, Roger D.; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J.; Haynes, Louise; Brigham, Gregory S.; Sparenborg, Steve; Hasson, Albert L.; Gray, Kevin M.

2014-01-01

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18–50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. PMID:25179587

The efficacy of traditional acupuncture on patients with chronic neck pain: study protocol of a randomized controlled trial.

PubMed

Yang, Yiling; Yan, Xiaoxia; Deng, Hongmei; Zeng, Dian; Huang, Jianpeng; Fu, Wenbin; Xu, Nenggui; Liu, Jianhua

2017-07-10

A large number of randomized trials on the use of acupuncture to treat chronic pain have been conducted. However, there is considerable controversy regarding the effectiveness of acupuncture. We designed a randomized trial involving patients with chronic neck pain (CNP) to investigate whether acupuncture is more effective than a placebo in treating CNP. A five-arm, parallel, single-blinded, randomized, sham-controlled trial was designed. Patients with CNP of more than 3 months' duration are being recruited from Guangdong Provincial Hospital of Chinese Medicine (China). Following examination, 175 patients will be randomized into one of five groups (35 patients in each group) as follows: a traditional acupuncture group (group A), a shallow-puncture group (group B), a non-acupoint acupuncture group (group C), a non-acupoint shallow-puncture group (group D) and a sham-puncture group (group E). The interventions will last for 20 min and will be carried out twice a week for 5 weeks. The primary outcome will be evaluated by changes in the Northwick Park Neck Pain Questionnaire (NPQ). Secondary outcomes will be measured by the pain threshold, the Short Form McGill Pain Questionnaire-2 (SF-MPQ-2), the 36-Item Short-Form Health Survey (SF-36) and diary entries. Analysis of the data will be performed at baseline, at the end of the intervention and at 3 months' follow-up. The safety of acupuncture will be evaluated at each treatment period. The purpose of this trial is to determine whether traditional acupuncture is more effective for chronic pain relief than sham acupuncture in adults with CNP, and to determine which type of sham acupuncture is the optimal control for clinical trials. Chinese Clinical Trial Registry: ChiCTR-IOR-15006886 . Registered on 2 July 2015.

MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study.

PubMed

Fox, Robert J; Cree, Bruce A C; De Sèze, Jerome; Gold, Ralf; Hartung, Hans-Peter; Jeffery, Douglas; Kappos, Ludwig; Kaufman, Michael; Montalbán, Xavier; Weinstock-Guttman, Bianca; Anderson, Britt; Natarajan, Amy; Ticho, Barry; Duda, Petra

2014-04-29

RESTORE was a randomized, partially placebo-controlled exploratory study evaluating multiple sclerosis (MS) disease activity during a 24-week interruption of natalizumab. Eligible patients were relapse-free through the prior year on natalizumab and had no gadolinium-enhancing lesions on screening brain MRI. Patients were randomized 1:1:2 to continue natalizumab, to switch to placebo, or to receive alternative immunomodulatory therapy (other therapies: IM interferon β-1a [IM IFN-β-1a], glatiramer acetate [GA], or methylprednisolone [MP]). During the 24-week randomized treatment period, patients underwent clinical and MRI assessments every 4 weeks. Patients (n = 175) were randomized to natalizumab (n = 45), placebo (n = 42), or other therapies (n = 88: IM IFN-β-1a, n = 17; GA, n = 17; MP, n = 54). Of 167 patients evaluable for efficacy, 49 (29%) had MRI disease activity recurrence: 0/45 (0%) natalizumab, 19/41 (46%) placebo, 1/14 (7%) IM IFN-β-1a, 8/15 (53%) GA, and 21/52 (40%) MP. Relapse occurred in 4% of natalizumab patients and in 15%-29% of patients in the other treatment arms. MRI disease activity recurred starting at 12 weeks (n = 3 at week 12) while relapses were reported as early as 4-8 weeks (n = 2 in weeks 4-8) after the last natalizumab dose. Overall, 50/167 patients (30%), all in placebo or other-therapies groups, restarted natalizumab early because of disease activity. MRI and clinical disease activity recurred in some patients during natalizumab interruption, despite use of other therapies. This study provides Class II evidence that for patients with MS taking natalizumab who are relapse-free for 1 year, stopping natalizumab increases the risk of MS relapse or MRI disease activity as compared with continuing natalizumab.

Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): protocol for the ICEPOC study.

PubMed

Barnestein-Fonseca, Pilar; Leiva-Fernández, José; Vidal-España, Francisca; García-Ruiz, Antonio; Prados-Torres, Daniel; Leiva-Fernández, Francisca

2011-02-14

Low therapeutic adherence to medication is very common. Clinical effectiveness is related to dose rate and route of administration and so poor therapeutic adherence can reduce the clinical benefit of treatment. The therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is extremely poor according to most studies. The research about COPD adherence has mainly focussed on quantifying its effect, and few studies have researched factors that affect non-adherence. Our study will evaluate the effectiveness of a multifactor intervention to improve the therapeutic adherence of COPD patients. A randomized controlled clinical trial with 140 COPD diagnosed patients selected by a non-probabilistic method of sampling. Subjects will be randomly allocated into two groups, using the block randomization technique. Every patient in each group will be visited four times during the year of the study. Motivational aspects related to adherence (beliefs and behaviour): group and individual interviews; cognitive aspects: information about illness; skills: inhaled technique training. Reinforcement of the cognitive-emotional aspects and inhaled technique training will be carried out in all visits of the intervention group. Adherence to a prescribed treatment involves a behavioural change. Cognitive, emotional and motivational aspects influence this change and so we consider the best intervention procedure to improve adherence would be a cognitive and emotional strategy which could be applied in daily clinical practice. Our hypothesis is that the application of a multifactor intervention (COPD information, dose reminders and reinforcing audiovisual material, motivational aspects and inhalation technique training) to COPD patients taking inhaled treatment will give a 25% increase in the number of patients showing therapeutic adherence in this group compared to the control group.We will evaluate the effectiveness of this multifactor intervention on patient adherence to inhaled drugs considering that it will be right and feasible to the clinical practice context. Current Controlled Trials ISRCTN18841601.

One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure.

PubMed

Mann, Douglas L; Lee, Randall J; Coats, Andrew J S; Neagoe, Gheorghe; Dragomir, Dinu; Pusineri, Enrico; Piredda, Massimo; Bettari, Luca; Kirwan, Bridget-Anne; Dowling, Robert; Volterrani, Maurizio; Solomon, Scott D; Sabbah, Hani N; Hinson, Andy; Anker, Stefan D

2016-03-01

AUGMENT-HF was an international, multicentre, prospective, open-label, randomized, controlled evaluation testing the hypothesis that Algisyl (injectable calcium alginate hydrogel) is superior to standard medical therapy (SMT) for improving functional capacity and clinical outcomes in patients with advanced heart failure (HF). We previously reported results following 6 months of follow-up. This report presents the results from 1 year of extended follow up for this clinical trial. We enrolled 78 patients with advanced HF, randomized (1:1), to Algisyl with SMT or SMT alone as previously reported. Patient inclusion criteria were LVEF ≤35%, peak VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m(2) (LVEDD/body surface area). Patients must have been on stable, evidence-based therapy for HF. A total of 58 patients, mean age 62.3 ± 9.6 years, with ischaemic (57.7%) or non-ischaemic (42.3%) HF completed 12 months of follow-up. Treatment with Algisyl was associated with improved peak VO2 at 12 months; treatment effect vs. control of +2.10 mL/kg/min (95% confidence interval 0.96-3.24, P < 0.001). Statistically significant improvements were observed for VO2 at anaerobic threshold, 6-min walk test distance, and NYHA functional class (all P < 0.001). Through 12 months of follow-up there were 4 (10.5%) deaths in the control group and 9 (22.5%) deaths in the Algisyl group. Algisyl in addition to SMT was more effective than SMT alone for providing sustained 1-year benefits in exercise capacity, symptoms, and clinical status for patients with advanced HF. These data support larger clinical evaluations of this novel therapy. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

A novel approach to assess the treatment response using Gaussian random field in PET

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wang, Mengdie; Guo, Ning; Hu, Guangshu

2016-02-15

Purpose: The assessment of early therapeutic response to anticancer therapy is vital for treatment planning and patient management in clinic. With the development of personal treatment plan, the early treatment response, especially before any anatomically apparent changes after treatment, becomes urgent need in clinic. Positron emission tomography (PET) imaging serves an important role in clinical oncology for tumor detection, staging, and therapy response assessment. Many studies on therapy response involve interpretation of differences between two PET images, usually in terms of standardized uptake values (SUVs). However, the quantitative accuracy of this measurement is limited. This work proposes a statistically robustmore » approach for therapy response assessment based on Gaussian random field (GRF) to provide a statistically more meaningful scale to evaluate therapy effects. Methods: The authors propose a new criterion for therapeutic assessment by incorporating image noise into traditional SUV method. An analytical method based on the approximate expressions of the Fisher information matrix was applied to model the variance of individual pixels in reconstructed images. A zero mean unit variance GRF under the null hypothesis (no response to therapy) was obtained by normalizing each pixel of the post-therapy image with the mean and standard deviation of the pretherapy image. The performance of the proposed method was evaluated by Monte Carlo simulation, where XCAT phantoms (128{sup 2} pixels) with lesions of various diameters (2–6 mm), multiple tumor-to-background contrasts (3–10), and different changes in intensity (6.25%–30%) were used. The receiver operating characteristic curves and the corresponding areas under the curve were computed for both the proposed method and the traditional methods whose figure of merit is the percentage change of SUVs. The formula for the false positive rate (FPR) estimation was developed for the proposed therapy response assessment utilizing local average method based on random field. The accuracy of the estimation was validated in terms of Euler distance and correlation coefficient. Results: It is shown that the performance of therapy response assessment is significantly improved by the introduction of variance with a higher area under the curve (97.3%) than SUVmean (91.4%) and SUVmax (82.0%). In addition, the FPR estimation serves as a good prediction for the specificity of the proposed method, consistent with simulation outcome with ∼1 correlation coefficient. Conclusions: In this work, the authors developed a method to evaluate therapy response from PET images, which were modeled as Gaussian random field. The digital phantom simulations demonstrated that the proposed method achieved a large reduction in statistical variability through incorporating knowledge of the variance of the original Gaussian random field. The proposed method has the potential to enable prediction of early treatment response and shows promise for application to clinical practice. In future work, the authors will report on the robustness of the estimation theory for application to clinical practice of therapy response evaluation, which pertains to binary discrimination tasks at a fixed location in the image such as detection of small and weak lesion.« less

Systematic review of atorvastatin for the treatment of Alzheimer's disease★

PubMed Central

Sun, Yuan; Wang, Genfa; Pan, Zhihong; Chen, Shuyan

2012-01-01

Objective: To assess the clinical efficacy and safety of atorvastatin in the treatment of Alzheimer's disease. Data Sources: Medline (1948/2011-04), Embase (1966/2011-04), Cochrane Library (Issue 3, 2011), Chinese National Knowledge Infrastructure (1989/2011-04), and the Chinese Biomedical Literature Database (1979/2011-04) were searched for randomized clinical trials regardless of language. Abstracts of conference papers were manually searched. Furthermore, Current Controlled Trials (http://controlled-trials.com), Clinical Trials.gov (http://clinicaltrials.gov), and Chinese Clinical Trial Registry (http://www.chictr.org) were also searched. Key words included Alzheimer disease, dementia, cognition, affection, memory dysfunction, hydroxymethylglutaryl-CoA reductase inhibitors, atorvastatin and statins. Data Selection: Randomized controlled trials of grade A or B according to quality evaluation criteria of the Cochrane Collaboration were selected, in which atorvastatin and placebo were used to evaluate the effects of atorvastatin in the treatment of Alzheimer's disease. Study methodological quality was evaluated based on criteria described in Cochrane Reviewer's Handbook 5.0.1. Revman 5.1 software was used for data analysis. Main Outcome Measures: Clinical efficacy, safety, withdrawal from the studies, and withdrawal due to adverse effects. Results: Two randomized controlled trials were included, one was scale A, and the other was scale B. All patients (n = 710, age range 50–90 years) were diagnosed as probable or possible mild to moderate Alzheimer's disease according to standard criteria and treated with atorvastatin 80 mg/d or placebo. There was no difference between the two groups in the final follow-up for Clinical Global Impression of Change scale (WMD = 0.13, 95%CI: –0.15 to 0.40), the Alzheimer's Disease Assessment Scale-cognitive subscale (WMD = 1.05, 95%CI: –3.06 to 6.05), Mini-Mental State Examination Scale (WMD = 0.77, 95%CI: –0.57 to 2.10), and the Neuropsychiatric Instrument (WMD = 2.07, 95%CI: –1.59 to 5.73). The rates of abnormal liver function, withdrawal from treatment, and withdrawal due to adverse effects were higher in the treatment group (OR = 7.86, 95%CI: 2.50-24.69; OR = 4.70, 95%CI: 2.61-8.44; and OR = 5.47, 95%CI: 3.01-9.94; respectively) compared with the placebo group. Conclusion: There is insufficient evidence to recommend atorvastatin for the treatment of mild to moderate Alzheimer's disease, because there was no benefit on general function, cognitive function or mental/behavior abnormality outcome measures. Efficacy and safety need to be confirmed by larger and higher quality randomized controlled trials, especially for moderate to severe Alzheimer's disease, because results of this systematic review may be limited by selection bias, implementation bias, as well as measurement bias. PMID:25657666

The effect of supervised Tai Chi intervention compared to a physiotherapy program on fall-related clinical outcomes: a randomized clinical trial.

PubMed

Tousignant, Michel; Corriveau, Hélène; Roy, Pierre-Michel; Desrosiers, Johanne; Dubuc, Nicole; Hébert, Réjean; Tremblay-Boudreault, Valérie; Beaudoin, Audrée-Jeanne

2012-01-01

To assess some fall-related clinical variables (balance, gait, fear of falling, functional autonomy, self-actualization and self-efficacy) that might explain the fact that supervised Tai Chi has a better impact on preventing falls compared to a conventional physiotherapy program. The participants (152 older adults over 65 who were admitted to a geriatric day hospital program) were randomly assigned to either a supervised Tai Chi group or the usual physiotherapy. The presence of the clinical variables related to falls was evaluated before the intervention (T1), immediately after (T2), and 12 months after the end of the intervention (T3). Both exercise programs significantly improved fall-related outcomes but only the Tai Chi intervention group decreased the incidence of falls. For both groups, most variables followed the same pattern, i.e. showed significant improvement with the intervention between T1 and T2, and followed by a statistically significant decrease at the T3 evaluation. However, self-efficacy was the only variable that improved solely with the Tai Chi intervention (p = 0.001). The impact of supervised Tai Chi on fall prevention can not be explained by a differential effect on balance, gait and fear of falling. It appeared to be related to an increase of general self-efficacy, a phenomenon which is not seen in the conventional physiotherapy program.

The effect of grapefruits (Citrus paradisi) on body weight and cardiovascular risk factors: A systematic review and meta-analysis of randomized clinical trials.

PubMed

Onakpoya, Igho; O'Sullivan, Jack; Heneghan, Carl; Thompson, Matthew

2017-02-11

The aim of this systematic review was to evaluate the evidence for or against the effectiveness of grapefruits (Citrus paradisi) on body weight, blood pressure, and lipid profile. Electronic searches were conducted in MEDLINE, EMBASE, AMED, and the Cochrane Clinical Trials databases to identify relevant human randomized clinical trials (RCTs). Hand searches of bibliographies were also conducted. Only overweight and obese subjects were included. The reporting quality was assessed using the CONSORT checklist, and the strength of the overall body of evidence was rated based on the GRADE criteria. One hundred and fifty four citations were identified and three RCTs with a total of 250 participants were included. The RCTs were of moderate quality. A meta-analysis for change in body weight failed to reveal a significant difference between grapefruits and controls, MD: -0.45 kg (95% CI: -1.06 to 0.16; I 2 = 53%, but analysis revealed a significant decrease in systolic blood pressure, MD: -2.43 mmHg (95% CI: -4.77 to -0.09; I 2 = 0%). Paucity in the number of RCTs, short durations of interventions, and lack of an established minimum effective dose limit the conclusions that can be drawn about the effects of grapefruit on body weight and metabolic parameters. Further clinical trials evaluating the effects of grapefruit are warranted.

Comparison of gray mineral trioxide aggregate and diluted formocresol in pulpotomized primary molars: a 6- to 24-month observation.

PubMed

Sushynski, John M; Zealand, Cameron M; Botero, Tatiana M; Boynton, James R; Majewski, Robert F; Shelburne, Charles E; Hu, Jan Chingchun

2012-01-01

The purpose of this multisite, multioperator, prospective, randomized, controlled clinical trial was to evaluate 2-year outcomes of diluted formocresol (DFC) compared to gray mineral trioxide aggregate (GMTA) as pulpotomy medicaments. Following the standard pulpotomy procedure, the pulp stumps of 252 primary molars in 168 healthy children were randomly covered with GMTA or DFC. Pulp chambers were filled with Intermediate Restorative Material (IRM(®)) and teeth were restored with stainless steel crowns. At each follow-up appointment, the clinical status of the treated tooth was assessed and radiographs were taken. A total of 694 clinical and radiographic evaluations were analyzed. Gender, study site, arch type, and tooth type did not influence treatment outcome. At the combined 6- to 24-month follow-up, clinical success in the DFC group was no different than for the GMTA group. Radiographically, a significantly lower success rate was found in the DFC group vs the MTA group at all time points (P<.01). Dentin bridge formation was observed at a significantly higher frequency among the GMTA group (P<.01), while internal root resorption was observed at a higher frequency in the DFC group (P<.01). At the combined 6- to 24-month follow-up, gray mineral trioxide aggregate demonstrated significantly better radiographic outcomes vs diluted formocresol as pulpotomy medicaments.

Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial.

PubMed

Orozco-Beltran, Domingo; Ruescas-Escolano, Esther; Navarro-Palazón, Ana Isabel; Cordero, Alberto; Gaubert-Tortosa, María; Navarro-Perez, Jorge; Carratalá-Munuera, Concepción; Pertusa-Martínez, Salvador; Soler-Bahilo, Enrique; Brotons-Muntó, Francisco; Bort-Cubero, Jose; Nuñez-Martinez, Miguel Angel; Bertomeu-Martinez, Vicente; Gil-Guillen, Vicente Francisco

2013-08-02

To evaluate the effectiveness of a new multifactorial intervention to improve health care for chronic ischemic heart disease patients in primary care. The strategy has two components: a) organizational for the patient/professional relationship and b) training for professionals. Experimental study. Randomized clinical trial. Follow-up period: one year. primary care, multicenter (15 health centers). For the intervention group 15 health centers are selected from those participating in ESCARVAL study. Once the center agreed to participate patients are randomly selected from the total amount of patients with ischemic heart disease registered in the electronic health records. For the control group a random sample of patients with ischemic heart disease is selected from all 72 health centers electronic records. This study aims to evaluate the efficacy of a multifactorial intervention strategy involving patients with ischemic heart disease for the improvement of the degree of control of the cardiovascular risk factors and of the quality of life, number of visits, and number of hospitalizations. NCT01826929.

Effect of intradermal human recombinant copper-zinc superoxide dismutase on random pattern flaps in rats.

PubMed

Schein, Ophir; Westreich, Melvyn; Shalom, Avshalom

2013-09-01

Studies have focused on enhancing flap viability using superoxide dismutase (SOD), but only a few used SOD from human origin, and most gave the compound systemically. We evaluated the ability of SOD to improve random skin flap survival using human recombinant copper-zinc superoxide dismutase (Hr-CuZnSOD) in variable doses, injected intradermally into the flap. Seventy male Sprague Dawley rats were randomly assigned into 4 groups. Cephalic random pattern flaps were elevated on their backs and intradermal injections of different dosages of Hr-CuZnSOD were given 15 minutes before surgery. Flap survival was evaluated by fluorescein fluorescence. Analysis of variance (ANOVA) and t test statistical analyses were performed. Flap survival in all treated groups was significantly better than in the controls. The beneficial effect of HR-CuZnSOD on flap survival is attained when it is given intradermally into the flap tissue. Theoretically, Hr-CuZnSOD delivered with local anesthetics used in flap elevation may be a valuable clinical tool. Copyright © 2012 Wiley Periodicals, Inc.

Effects of neurofeedback on the short-term memory and continuous attention of patients with moderate traumatic brain injury: A preliminary randomized controlled clinical trial.

PubMed

Rostami, Reza; Salamati, Payman; Yarandi, Kourosh Karimi; Khoshnevisan, Alireza; Saadat, Soheil; Kamali, Zeynab Sadat; Ghiasi, Somaie; Zaryabi, Atefeh; Ghazi Mir Saeid, Seyed Shahab; Arjipour, Mehdi; Rezaee-Zavareh, Mohammad Saeid; Rahimi-Movaghar, Vafa

2017-10-01

There are some studies which showed neurofeedback therapy (NFT) can be effective in clients with traumatic brain injury (TBI) history. However, randomized controlled clinical trials are still needed for evaluation of this treatment as a standard option. This preliminary study was aimed to evaluate the effect of NFT on continuous attention (CA) and short-term memory (STM) of clients with moderate TBI using a randomized controlled clinical trial (RCT). In this preliminary RCT, seventeen eligible patients with moderate TBI were randomly allocated in two intervention and control groups. All the patients were evaluated for CA and STM using the visual continuous attention test and Wechsler memory scale-4th edition (WMS-IV) test, respectively, both at the time of inclusion to the project and four weeks later. The intervention group participated in 20 sessions of NFT through the first four weeks. Conversely, the control group participated in the same NF sessions from the fifth week to eighth week of the project. Eight subjects in the intervention group and five subjects in the control group completed the study. The mean and standard deviation of participants' age were (26.75 ± 15.16) years and (27.60 ± 8.17) years in experiment and control groups, respectively. All of the subjects were male. No significant improvement was observed in any variables of the visual continuous attention test and WMS-IV test between two groups (p ≥ 0.05). Based on our literature review, it seems that our study is the only study performed on the effect of NFT on TBI patients with control group. NFT has no effect on CA and STM in patients with moderate TBI. More RCTs with large sample sizes, more sessions of treatment, longer time of follow-up and different protocols are recommended. Copyright © 2017 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Production and hosting by Elsevier B.V. All rights reserved.

The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial.

PubMed

Fontes-Carvalho, Ricardo; Sampaio, Francisco; Teixeira, Madalena; Gama, Vasco; Leite-Moreira, Adelino F

2015-03-12

Exercise training is effective in improving functional capacity and quality of life in patients with coronary artery disease, but its effects on left ventricular systolic and diastolic function are controversial. Diastolic dysfunction is a major determinant of adverse outcome after myocardial infarction and, contrary to systolic function, no therapy or intervention has proved to significantly improve diastolic function. Data from animal studies and from patients with diastolic heart failure has suggested that exercise training can have a positive effect on diastolic function parameters. This trial aims to evaluate if a structured exercise training program can improve resting left ventricular diastolic and systolic function in patients who have had an acute myocardial infarction. This is a phase II, prospective, randomized, open-label, blinded-endpoint trial that will include at least 96 consecutive patients who have had an acute myocardial infarction one month previously. Patients will be randomized (1:1) to an exercise training program or a control group, receiving standard of care. At enrolment, and at the end of the follow-up period, patients will be submitted to an echocardiography (with detailed assessment of diastolic and systolic function using recent consensus guidelines), cardiopulmonary exercise testing, an anthropometric assessment, blood testing, and clinical evaluation. Patients randomized to the intervention group will be submitted to an eight-week outpatient exercise program, combining endurance and resistance training, for three sessions per week. The primary endpoint will be the change in lateral E' velocity immediately after the eight-week exercise training program. Secondary endpoints will include other echocardiographic parameters of left ventricular diastolic and systolic function, cardiac structure, metabolic and inflammation biomarkers (high-sensitivity C-reactive protein and pro-BNP), functional capacity (peak oxygen consumption and anaerobic threshold) and anthropometric measurements. New strategies that can improve left ventricular diastolic function are clinically needed. This will be the first trial to evaluate, in patients who have had an acute myocardial infarction, the effects of a structured program of exercise training on diastolic and systolic function, assessed by novel echocardiographic parameters. Registered with ClinicalTrials.gov (reference: NCT02224495 ) on 21 August 2014.

Is quadriceps tendon a better graft choice than patellar tendon? a prospective randomized study.

PubMed

Lund, Bent; Nielsen, Torsten; Faunø, Peter; Christiansen, Svend Erik; Lind, Martin

2014-05-01

The purpose of this randomized controlled study was to compare knee stability, kneeling pain, harvest site pain, sensitivity loss, and subjective clinical outcome after primary anterior cruciate ligament (ACL) reconstruction with either bone-patellar tendon-bone (BPTB) or quadriceps tendon-bone (QTB) autografts in a noninferiority study design. From 2005 to 2009, a total of 51 patients were included in the present study. Inclusion criteria were isolated ACL injuries in adults. Twenty-five patients were randomized to BPTB grafts and 26 to QTB grafts. An independent examiner performed follow-up evaluations 1 and 2 years postoperatively. Anteroposterior knee laxity was measured with a KT-1000 arthrometer (MEDmetric, San Diego, CA). Anterior knee pain was assessed clinically and by knee-walking ability. Knee Injury and Osteoarthritis Outcome Score (KOOS) and subjective International Knee Documentation Committee (IKDC) score were used for patient-evaluated outcome. Anterior knee laxity was equal between the 2 groups with KT-1000 values of 1.1 ± 1.4 mm and 0.8 ± 1.7 mm standard deviation (SD) at follow-up in QTB and BPTB groups, respectively (P = .65), whereas positive pivot shift test results were seen less frequently (14% compared with 38%, respectively; P = .03). Anterior kneeling pain, evaluated by the knee walking ability test, was significantly less in the QTB group, with only 7% of patients grading knee walking as difficult or impossible compared with 34% in the BPTB group. At 1 and 2 years' follow-up, there was no difference between the 2 groups in subjective patient-evaluated outcome. The IKDC score was 75 ± 13 patients and 76 ± 16 SD at 1-year follow-up in QTB and BPTB groups, respectively (P = .78). At 2 years, 12 patients were lost to follow-up, resulting in 18 in the BPTB group and 21 in the QTB group. The use of the QTB graft results in less kneeling pain, graft site pain, and sensitivity loss than seen with BPTB grafts; however, similar anterior knee stability and subjective outcomes are seen. The results of this study show that QTB is a viable option for ACL reconstruction. Level II, randomized controlled clinical trial. Copyright © 2014 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Antiviral therapeutics for the treatment of Ebola virus infection.

PubMed

Cardile, Anthony P; Downey, Lydia G; Wiseman, Perry D; Warren, Travis K; Bavari, Sina

2016-10-01

There have been significant developments in Ebola virus therapeutics. While the efficacy of several products was evaluated in the recent West Africa outbreak, a licensed treatment for EBOV disease remains elusive. Factors that negatively impacted the execution of clinical trials included an overall lack of world readiness to conduct clinical trials in an outbreak setting, ethical concerns limiting implementation of the randomized controlled trials in an outbreak setting, and a decline in case numbers by the time resources were mobilized to conduct clinical trials. We summarize relevant therapeutics that underwent clinical trials during the West Africa outbreak and highlight promising candidates under advanced development. Published by Elsevier Ltd.

A call for randomized controlled cost-effectiveness analysis of percutaneous transluminal coronary angioplasty.

PubMed

Holly, N

1988-01-01

A rapidly evolving technology, percutaneous transluminal coronary angioplasty, is increasingly favored over bypass surgery for treating some types of coronary stenosis because of its less traumatic invasion, better recovery response, and lower initial cost. However, substantially higher failure rates in initial procedures offset PTCA's savings to an unknown extent and cloud analysis of its overall impact. Lack of randomized clinical data precludes valid cost-effectiveness comparison of the technologies at this time. Criteria for establishing valid data and evaluations of currently available data are described in this paper.

5As Team obesity intervention in primary care: development and evaluation of shared decision-making weight management tools.

PubMed

Osunlana, A M; Asselin, J; Anderson, R; Ogunleye, A A; Cave, A; Sharma, A M; Campbell-Scherer, D L

2015-08-01

Despite several clinical practice guidelines, there remains a considerable gap in prevention and management of obesity in primary care. To address the need for changing provider behaviour, a randomized controlled trial with convergent mixed method evaluation, the 5As Team (5AsT) study, was conducted. As part of the 5AsT intervention, the 5AsT tool kit was developed. This paper describes the development process and evaluation of these tools. Tools were co-developed by the multidisciplinary research team and the 5AsT, which included registered nurses/nurse practitioners (n = 15), mental health workers (n = 7) and registered dieticians (n = 7), who were previously randomized to the 5AsT intervention group at a primary care network in Edmonton, Alberta, Canada. The 5AsT tool development occurred through a practice/implementation-oriented, need-based, iterative process during learning collaborative sessions of the 5AsT intervention. Feedback during tool development was received through field notes and final provider evaluation was carried out through anonymous questionnaires. Twelve tools were co-developed with 5AsT. All tools were evaluated as either 'most useful' or 'moderately useful' in primary care practice by the 5AsT. Four key findings during 5AsT tool development were the need for: tools that were adaptive, tools to facilitate interdisciplinary practice, tools to help patients understand realistic expectations for weight loss and shared decision-making tools for goal setting and relapse prevention. The 5AsT tools are primary care tools which extend the utility of the 5As of obesity management framework in clinical practice. © 2015 The Authors. Clinical Obesity published by John Wiley & Sons Ltd on behalf of World Obesity.

Comparative trial of the use of antiplatelet and oral anticoagulant in thrombosis prophylaxis in patients undergoing total cavopulmonary operation with extracardiac conduit: echocardiographic, tomographic, scintigraphic, clinical and laboratory analysis.

PubMed

Pessotti, Cristiane Felix Ximenes; Jatene, Marcelo Biscegli; Jatene, Ieda Biscegli; Oliveira, Patrícia Marques; Succi, Fabiana Moreira Passos; Moreira, Valeria de Melo; Lopes, Rafael Willain; Pedra, Simone Rolim Fernandes Fontes

2014-01-01

To compare the efficacy of aspirin and warfarin for prophylaxis of thrombosis in patients undergoing total cavopulmonary anastomosis. Evaluate whether coagulation factors (VII, VIII and protein C), clinical data, fenestration or hemodynamic factors, interfere with postoperative thrombosis. A prospective, randomized study of 30 patients, randomized into Group I (Warfarin) and Group II (AAS), underwent total cavopulmonary shunt with extracardiac conduit, between 2008 and 2011, with follow-up by clinical visits to evaluate side effects and adhesion. Performed transesophageal echocardiography in post operatory time, 3, 6,12 and 24 months; angiotomography at 6, 12 and 24 months to evaluate changes in the internal tube wall or thrombi and pulmonary scintigraphy to evaluate possible PTE. Two deaths in group I; 33.3% of patients had thrombus (46.7% in Group II). The previous occurrence of thrombus and low levels of coagulation protein C were the only factors that influenced the time free of thrombus (P=0.035 and 0.047). Angiotomographic evaluation: 35.7% in group II presented material accumulation greater than 2 mm (P=0.082). Scintigraphy: two patients had PTE in group II. Five patients had difficulty to comply with the treatment, 4 in group I with INR ranging from 1 to 6.4. The previous occurrence of thrombus is a risk factor for thrombosis in the postoperative period. Patients using AAS tend to deposit material in the tube wall. The small sample size did not allow to conclude which is the most effective drug in the prevention of thrombosis in this population.

The role of gender in a smoking cessation intervention: a cluster randomized clinical trial

PubMed Central

2011-01-01

Background The prevalence of smoking in Spain is high in both men and women. The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain. Methods This study was a secondary analysis of a cluster randomized clinical trial in which the randomization unit was the Basic Care Unit (family physician and nurse who care for the same group of patients). The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline. A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included (2003-2005). The success rate was measured by a six-month continued abstinence rate at the one-year follow-up. A logistic mixed-effects regression model, taking Basic Care Units as random-effect parameter, was performed in order to analyze gender as a predictor of smoking cessation. Results At the one-year follow-up, the six-month continuous abstinence quit rate was 9.4% in men and 8.5% in women (p = 0.400). The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders (OR adjusted = 0.9, 95% CI = 0.7-1.2). Conclusions Gender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers. ClinicalTrials.gov Identifier NCT00125905. PMID:21605389

Methodological and ethical aspects of randomized controlled clinical trials in minors with malignant diseases.

PubMed

Rothenberger, Lillian G; Henschel, Andreas Dirk; Schrey, Dominik; Becker, Andreas; Boos, Joachim

2011-10-01

Due to the new European regulations for pediatric medications, future clinical trials will include an increasing number of minors. It is therefore important to reconsider and evaluate recent methodological and ethical aspects of clinical trials in minors. The following questions were investigated: How are randomized controlled clinical trials (RCTs) performed in practice? Do investigators take into consideration biomedical ethical principles, explicated for example by Beauchamp and Childress, when planning and conducting a trial? The study was conducted in a descriptive manner. A systematic, algorithm-guided search focusing on RCTs in minors with malignant diseases was carried out in PubMed. One-thousand-nine-hundred-sixty-two publications from 2001 to 2005 were randomized in sequence. The first 1,000 publications were screened according to a priori defined inclusion criteria. One hundred seventy-five publications met the criteria and were reviewed using the SIGN methodological checklist (2004), the CONSORT Statement (2001, section Methods, items 3-12) and indicators for ethical aspects. Seventeen publications were checked by two raters. Information on randomization and blinding was often equivocal. The publications were mainly rated positive for the criteria of the SIGN checklist, and mostly rated negative for the additional items of the CONSORT Statement. Regarding the ethical principles, only few contributions were found in the publications. Inter-rater reliability was good. In the publications analyzed, we found only limited information concerning methods and reflections on ethical principles of the trials. Improvements are thus necessary and possible. We suggest how such trials and their respective publications can be optimized for these aspects. Copyright © 2011 Wiley-Liss, Inc.

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

PubMed

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

2017-08-01

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

Personalized Risk Prediction in Clinical Oncology Research: Applications and Practical Issues Using Survival Trees and Random Forests.

PubMed

Hu, Chen; Steingrimsson, Jon Arni

2018-01-01

A crucial component of making individualized treatment decisions is to accurately predict each patient's disease risk. In clinical oncology, disease risks are often measured through time-to-event data, such as overall survival and progression/recurrence-free survival, and are often subject to censoring. Risk prediction models based on recursive partitioning methods are becoming increasingly popular largely due to their ability to handle nonlinear relationships, higher-order interactions, and/or high-dimensional covariates. The most popular recursive partitioning methods are versions of the Classification and Regression Tree (CART) algorithm, which builds a simple interpretable tree structured model. With the aim of increasing prediction accuracy, the random forest algorithm averages multiple CART trees, creating a flexible risk prediction model. Risk prediction models used in clinical oncology commonly use both traditional demographic and tumor pathological factors as well as high-dimensional genetic markers and treatment parameters from multimodality treatments. In this article, we describe the most commonly used extensions of the CART and random forest algorithms to right-censored outcomes. We focus on how they differ from the methods for noncensored outcomes, and how the different splitting rules and methods for cost-complexity pruning impact these algorithms. We demonstrate these algorithms by analyzing a randomized Phase III clinical trial of breast cancer. We also conduct Monte Carlo simulations to compare the prediction accuracy of survival forests with more commonly used regression models under various scenarios. These simulation studies aim to evaluate how sensitive the prediction accuracy is to the underlying model specifications, the choice of tuning parameters, and the degrees of missing covariates.

Dynamic lumbopelvic stabilization for treatment of stress urinary incontinence in women: Controlled and randomized clinical trial.

PubMed

de Souza Abreu, Nathalia; de Castro Villas Boas, Bia; Netto, José Murilo Bastos; Figueiredo, André Avarese

2017-11-01

To compare the results of the dynamic lumbopelvic stabilization (DLS) exercises with exercises for the pelvic floor muscles (PFM) in women with stress urinary incontinence. Randomized controlled clinical trial comparing 17 women submitted to the DLS with 16 women submitted to the exercises for the PFM. The evaluated outcomes were incontinence severity, quality of life (QoL), and impression of improvement in three moments. Significance was set at 5%. For socio-demographic and clinical variables, only climacteric was more prevalent in the DLS group (82% vs. 44%, P = 0.02). Soon after the intervention, there was no difference between the groups in relation to the outcomes evaluated. In the evaluation after 90 days, the DLS group presented better values for the severity of the losses (4.1 ± 2.6 vs. 5.7 ± 2.4, P = 0.006, d = 0.64), daytime frequency (4.6 ± 0.4 vs. 6.2 ± 0.6, P < 0.001, d = 2.67), and nighttime frequency (0.4 ± 0.3 vs. 1.4 ± 0.5, P < 0.001, d = 2.50), QoL and impression of improvement (P < 0.001). After treatment, the DLS plus PFM exercise patients had results similar to those performing PFM exercises alone. However, the DLS plus PFM exercises were superior in the outcomes of incontinence severity, QoL, and impression of improvement in the post-90-day evaluation, showing longer lasting effect. © 2017 Wiley Periodicals, Inc.

A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

PubMed

McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

2001-05-01

Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically significant. In addition, there were more unscheduled visits to the urology clinic, emergency room or primary physician office by boys with than without a dressing. Furthermore, 29% of the parents were not psychologically prepared to remove the dressing and 12% were so reluctant that the dressing was removed at the urology outpatient clinic. The surgical outcome and rate of adverse events or complications were not compromised without a postoperative dressing. An absent dressing simplified postoperative ambulatory parent delivered home care. We recommend that dressings should be omitted from routine use after hypospadias repair.

Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

PubMed

Wu, Xiuwen; Ren, Jianan; Wang, Gefei; Wang, Jianzhong; Wang, Feng; Fan, Yueping; Li, Yuanxin; Han, Gang; Zhou, Yanbing; Song, Xiaofei; Quan, Bin; Yao, Min; Li, Jieshou

2015-10-07

The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. NCT01828892 . Registration date: April 2013.

A systematic review of measurement of endoscopic disease activity and mucosal healing in Crohn's disease: recommendations for clinical trial design.

PubMed

Khanna, Reena; Bouguen, Guillaume; Feagan, Brian G; DʼHaens, Geert; Sandborn, William J; Dubcenco, Elena; Baker, K Adam; Levesque, Barrett G

2014-10-01

Crohn's disease (CD) is a chronic idiopathic inflammatory disorder of the gastrointestinal tract. Recently, mucosal healing has been proposed as a goal of therapy because clinical symptoms are subjective. Evaluative indices that measure endoscopic disease activity are required to define mucosal healing for clinical trials. The primary objective of this systematic review was to assess the existing evaluative indices that measure disease activity in CD and evaluate their role as outcome measures in clinical trials. A systematic literature review was performed using MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and DDW abstracts to identify randomized controlled trials and controlled clinical trials that used a relevant evaluative index from inception to February 2013. The data obtained from these trials were reviewed and summarized. The initial literature searches identified 2300 citations. After duplicates were removed, 1454 studies remained. After application of the apriori inclusion and exclusion criteria, 109 articles were included and 3 were identified with handsearches. In total, 9 evaluative indices for CD were identified and reviewed. The Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score in Crohn's Disease (SES-CD) are indices with the most extensively described operating properties. Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for CD. Currently, the CDEIS and SES-CD have the most data regarding operating properties; however, further validation is required.

Magnetic resonance imaging in the evaluation of clinical treatment of otospongiosis: a pilot study.

PubMed

de Oliveira Vicente, Andy; Chandrasekhar, Sujana S; Yamashita, Helio K; Cruz, Oswaldo Laercio M; Barros, Flavia A; Penido, Norma O

2015-06-01

To evaluate the applicability of magnetic resonance imaging (MRI) as a method for monitoring the activity of otospongiotic lesions before and after clinical treatment. Prospective, randomized, controlled, double-blind study. One single tertiary care institution in a large, cosmopolitan city. Twenty-six patients (n = 42 ears) with clinical, audiometric, and tomographic diagnosis of otosclerosis were enrolled. If computed tomography (CT) demonstrated active lesions, these patients underwent MRI to detect otospongiotic foci, seen as areas of gadolinium enhancement. Patients were divided into 3 groups and received treatment with placebo, sodium alendronate, or sodium fluoride for 6 months. After this period, clinical and audiometric evaluations and a second MRI were performed. Each MRI was evaluated by both a neuroradiologist and an otolaryngologist in a subjective (visual) and objective (using specific eFilm Workstation software) manner. Otospongiosis was most predominantly identified in the region anterior to the oval window, and this site was reliable for comparing pre- and posttreatment scans. The patients in the alendronate and sodium fluoride groups had MRI findings that suggested a decrease in activity of otospongiotic lesions, more relevant in the alendronate group. These findings were statistically significant for both subjective and objective MRI evaluations. MRI shows higher sensitivity than clinical or audiometric assessment for detecting reduction in activity of otospongiosis. The objective MRI evaluation based on software analysis was the most accurate method of monitoring clinical treatment response in otospongiosis. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

PubMed

Del Paggio, J C; Azariah, B; Sullivan, R; Hopman, W M; James, F V; Roshni, S; Tannock, I F; Booth, C M

2017-01-01

The European Society for Medical Oncology (ESMO) recently released a magnitude of clinical benefit scale (ESMO-MCBS) for systemic therapies for solid cancers. Here, we evaluate contemporary randomized controlled trials (RCTs) against the proposed ESMO thresholds for meaningful clinical benefit. RCTs evaluating systemic therapy for breast cancer, nonsmall cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic cancer published 2011-2015 were reviewed. Data were abstracted regarding trial characteristics and outcomes, and these were applied to the ESMO-MCBS. We also determined whether RCTs were designed to detect an effect that would meet clinical benefit as defined by the ESMO-MCBS. About 277 eligible RCTs were included (40% breast, 31% NSCLC, 22% CRC, 6% pancreas). Median sample size was 532 and 83% were funded by industry. Among all 277 RCTs, the experimental therapy was statistically superior to the control arm in 138 (50%) trials: results of only 31% (43/138) of these trials met the ESMO-MCBS clinical benefit threshold. RCTs with curative intent were more likely to meet clinically meaningful thresholds than those with palliative intent [61% (19/31) versus 22% (24/107), P < 0.001]. Among the 226 RCTs for which the ESMO-MCBS could be applied, 31% (70/226) were designed to detect an effect size that could meet ESMO-MCBS thresholds. Less than one-third of contemporary RCTs with statistically significant results meet ESMO thresholds for meaningful clinical benefit, and this represents only 15% of all published trials. Investigators, funding agencies, regulatory agencies, and industry should adopt more stringent thresholds for meaningful benefit in the design of future RCTs. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Spine device clinical trials: design and sponsorship.

PubMed

Cher, Daniel J; Capobianco, Robyn A

2015-05-01

Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (p<.0001) and larger sample sizes. There were very few US-based multicenter randomized trials of spine devices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

Implementing collaborative care for depression treatment in primary care: A cluster randomized evaluation of a quality improvement practice redesign

PubMed Central

2011-01-01

Background Meta-analyses show collaborative care models (CCMs) with nurse care management are effective for improving primary care for depression. This study aimed to develop CCM approaches that could be sustained and spread within Veterans Affairs (VA). Evidence-based quality improvement (EBQI) uses QI approaches within a research/clinical partnership to redesign care. The study used EBQI methods for CCM redesign, tested the effectiveness of the locally adapted model as implemented, and assessed the contextual factors shaping intervention effectiveness. Methods The study intervention is EBQI as applied to CCM implementation. The study uses a cluster randomized design as a formative evaluation tool to test and improve the effectiveness of the redesign process, with seven intervention and three non-intervention VA primary care practices in five different states. The primary study outcome is patient antidepressant use. The context evaluation is descriptive and uses subgroup analysis. The primary context evaluation measure is naturalistic primary care clinician (PCC) predilection to adopt CCM. For the randomized evaluation, trained telephone research interviewers enrolled consecutive primary care patients with major depression in the evaluation, referred enrolled patients in intervention practices to the implemented CCM, and re-surveyed at seven months. Results Interviewers enrolled 288 CCM site and 258 non-CCM site patients. Enrolled intervention site patients were more likely to receive appropriate antidepressant care (66% versus 43%, p = 0.01), but showed no significant difference in symptom improvement compared to usual care. In terms of context, only 40% of enrolled patients received complete care management per protocol. PCC predilection to adopt CCM had substantial effects on patient participation, with patients belonging to early adopter clinicians completing adequate care manager follow-up significantly more often than patients of clinicians with low predilection to adopt CCM (74% versus 48%%, p = 0.003). Conclusions Depression CCM designed and implemented by primary care practices using EBQI improved antidepressant initiation. Combining QI methods with a randomized evaluation proved challenging, but enabled new insights into the process of translating research-based CCM into practice. Future research on the effects of PCC attitudes and skills on CCM results, as well as on enhancing the link between improved antidepressant use and symptom outcomes, is needed. Trial Registration ClinicalTrials.gov: NCT00105820 PMID:22032247

Partial inferior turbinectomy in rhinoseptoplasty has no effect in quality-of-life outcomes: A randomized clinical trial.

PubMed

de Moura, Bianca H; Migliavacca, Raphaella O; Lima, Rafaela K; Dolci, José E L; Becker, Martina; Feijó, Cássia; Brauwers, Elisa; Lavinsky-Wolff, Michelle

2018-01-01

Evaluate the impact of endoscopic partial inferior turbinectomy (EPIT) associated with primary rhinoseptoplasty on quality-of-life outcomes (QOL), complications, and surgical duration. Randomized clinical trial. Individuals with nasal obstruction aged ≥ 16 years who were candidates for functional and aesthetics primary rhinoseptoplasty were evaluated from March 2014 through May 2015. Eligible participants were randomly allocated to rhinoseptoplasty with or without EPIT (excision of one-third of the inferior turbinates). Fifty patients were studied. Most were Caucasian and had moderate/severe allergic rhinitis symptoms. Mean age was 36 ( ± 14.5) years. Rhinoseptoplasty was associated with improvement in all QOL scores irrespective of turbinate intervention (P < 0.001). Analysis of covariance was conducted to control for potential confounders. There was no difference between the groups in absolute score changes for Nasal Obstruction Symptom Evaluation-Portuguese (NOSE-p) (-50.5 vs. -47.6; P  = 0.723), Rhinoplasty Outcome Evaluation (ROE) (47 vs. 44.8; P = 0.742), and all World Health Organization Quality of Life Scale-Abbreviated (WHOQOL-bref) score domains (P  > 0.05). There were no differences between the groups regarding presence of the complications. Surgical duration was higher in the EPIT group (212 minutes ± 7.8 vs. 159.1 ± 5.6; P ? 0.001). Turbinate reduction through EPIT during primary rhinoseptoplasty did not improve short-term general and specific QOL outcomes. The use of EPIT increases surgical time considerably without improving QOL scores. There was no difference in postoperative incidence of complications, suggesting that EPIT is a safe technique. 1b. Laryngoscope, 128:57-63, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.

PubMed

Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

2014-09-19

To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Cohort embedded pragmatic randomized controlled trial. Trials registered on ClinicalTrials.gov. 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance). The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed. Among 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001). Sending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254. © Maruani et al 2014.

Modular Approach to Therapy for Anxiety, Depression, Trauma, or Conduct Problems in outpatient child and adolescent mental health services in New Zealand: study protocol for a randomized controlled trial.

PubMed

Lucassen, Mathijs F G; Stasiak, Karolina; Crengle, Sue; Weisz, John R; Frampton, Christopher M A; Bearman, Sarah Kate; Ugueto, Ana M; Herren, Jennifer; Cribb-Su'a, Ainsleigh; Faleafa, Monique; Kingi-'Ulu'ave, Denise; Loy, Jik; Scott, Rebecca M; Hartdegen, Morgyn; Merry, Sally N

2015-10-12

Mental health disorders are common and disabling for young people because of the potential to disrupt key developmental tasks. Implementation of evidence-based psychosocial therapies in New Zealand is limited, owing to the inaccessibility, length, and cost of training in these therapies. Furthermore, most therapies address one problem area at a time, although comorbidity and changing clinical needs commonly occur in practice. A more flexible approach is needed. The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC) is designed to overcome these challenges; it provides a range of treatment modules addressing different problems, within a single training program. A clinical trial of MATCH-ADTC in the USA showed that MATCH-ADTC outperformed usual care and standard evidence-based treatment on several clinical measures. We aim to replicate these findings and evaluate the impact of providing training and supervision in MATCH-ADTC to: (1) improve clinical outcomes for youth attending mental health services; (2) increase the amount of evidence-based therapy content; (3) increase the efficiency of service delivery. This is an assessor-blinded multi-site effectiveness randomized controlled trial. Randomization occurs at two levels: (1) clinicians (≥60) are randomized to intervention or usual care; (2) youth participants (7-14 years old) accepted for treatment in child and adolescent mental health services (with a primary disorder that includes anxiety, depression, trauma-related symptoms, or disruptive behavior) are randomly allocated to receive MATCH-ADTC or usual care. Youth participants are recruited from 'mainstream', Māori-specific, and Pacific-specific child and adolescent mental health services. We originally planned to recruit 400 youth participants, but this has been revised to 200 participants. Centralized computer randomization ensures allocation concealment. The primary outcome measures are: (i) the difference in trajectory of change of clinical severity between groups (using the parent-rated Brief Problem Monitor); (ii) clinicians' use of evidence-based treatment procedures during therapy sessions; (iii) total time spent by clinicians delivering therapy. If MATCH-ADTC demonstrates effectiveness it could offer a practical efficient method to increase access to evidence-based therapies, and improve outcomes for youth attending secondary care services. Australian and New Zealand Clinical Trials Registry ACTRN12614000297628 .

COACH trial: A randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: Rationale and design

PubMed Central

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-01-01

Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. PMID:21241828

COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

PubMed

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-05-01

Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

Comparing the effect of office hysteroscopy with endometrial scratch versus office hysteroscopy on intrauterine insemination outcome: a randomized controlled trial.

PubMed

El-Khayat, Waleed; Elsadek, Mostafa; Saber, Waleed

2015-11-01

To evaluate the role of endometrial injury in the cycle preceding ovarian stimulation for intrauterine insemination (IUI) cycle on the clinical pregnancy rate. This was a prospective randomized controlled trial which included three hundred and thirty two infertile women with an indication for IUI. The subjects were randomly divided into two groups. The intervention group (group A) (n=166) subjects underwent office hysteroscopy with endometrial injury using grasping forceps with teeth, while the control group (group B) (n=166) subjects underwent office hysteroscopy alone without endometrial injury. Primary outcome was clinical pregnancy rate. There were no significant differences in baseline or clinical characteristics between the groups. There were no significant differences in clinical pregnancy rate [13.8% (23/166) versus 12% (20/166); RR 1.15 (95% CI 0.66-2.01), p=0.62]. The abortion rate [4.3% (1/23) versus 15% (3/20); RR 0.29 (95% CI 0.03-2.57), p=0.27], the multiple pregnancy rate [13% (3/23) versus 15% (3/20); RR 0.87 (95% CI 0.20-3.83), p=0.85] and the live birth rate [13.6% (22/166) versus 10.4% (17/166); RR 1.28 (95% CI 0.71-2.32), p=0.42]. There is no evidence of significant difference on the clinical pregnancy rate when endometrial scratching during hysteroscopy is compared to only hysteroscopy in women undergoing IUI. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Exercise and well-being: a review of mental and physical health benefits associated with physical activity.

PubMed

Penedo, Frank J; Dahn, Jason R

2005-03-01

This review highlights recent work evaluating the relationship between exercise, physical activity and physical and mental health. Both cross-sectional and longitudinal studies, as well as randomized clinical trials, are included. Special attention is given to physical conditions, including obesity, cancer, cardiovascular disease and sexual dysfunction. Furthermore, studies relating physical activity to depression and other mood states are reviewed. The studies include diverse ethnic populations, including men and women, as well as several age groups (e.g. adolescents, middle-aged and older adults). Results of the studies continue to support a growing literature suggesting that exercise, physical activity and physical-activity interventions have beneficial effects across several physical and mental-health outcomes. Generally, participants engaging in regular physical activity display more desirable health outcomes across a variety of physical conditions. Similarly, participants in randomized clinical trials of physical-activity interventions show better health outcomes, including better general and health-related quality of life, better functional capacity and better mood states. The studies have several implications for clinical practice and research. Most work suggests that exercise and physical activity are associated with better quality of life and health outcomes. Therefore, assessment and promotion of exercise and physical activity may be beneficial in achieving desired benefits across several populations. Several limitations were noted, particularly in research involving randomized clinical trials. These trials tend to involve limited sample sizes with short follow-up periods, thus limiting the clinical implications of the benefits associated with physical activity.

Topical Application of Honey on Surgical Wounds: A Randomized Clinical Trial.

PubMed

Goharshenasan, Peiman; Amini, Shahideh; Atria, Ali; Abtahi, Hamidreza; Khorasani, Ghasemali

2016-01-01

The antimicrobial and anti-inflammatory activity of honey and its ability to accelerate wound healing make it an attractive option in surgical wound care. We performed a randomized clinical trial to compare the efficacy of honey dressing with conventional dressing regarding the aesthetic outcome. Bilateral symmetric incisions in randomly selected plastic surgical patients were randomly covered postoperatively with conventional dressing and honey dressing for five days. The aesthetic outcome of the two sides was rated on a Visual Analog Scale by the surgeon and the patient and compared at month three and six after surgery. Seventy two symmetrical incisions in 52 patients were evaluated during the study. The mean width of the scar after the third and the sixth month was 3.64 +/- 0.83 mm and 3.49 +/- 0.87 mm on the side that received honey dressing and 5.43 +/- 0.05 mm and 5.30+/- 1.35 mm in the control group. Wilcoxon signed-rank test showed significant difference between honey and conventional dressing outcomes at third and sixth month (p < 0.001). The healing process of the surgical wound and its final aesthetic result could be improved by using honey dressing. © 2016 S. Karger GmbH, Freiburg.

Clinical Effectiveness of Different Polishing Systems and Self-Etch Adhesives in Class V Composite Resin Restorations: Two-Year Randomized Controlled Clinical Trial.

PubMed

Jang, J-H; Kim, H-Y; Shin, S-M; Lee, C-O; Kim, D S; Choi, K-K; Kim, S-Y

The aim of this randomized controlled clinical trial was to compare the clinical effectiveness of different polishing systems and self-etch adhesives in class V composite resin restorations. A total of 164 noncarious cervical lesions (NCCLs) from 35 patients were randomly allocated to one of four experimental groups, each of which used a combination of polishing systems and adhesives. The two polishing systems used were Sof-Lex XT (Sof), a multistep abrasive disc, and Enhance/Pogo (EP), a simplified abrasive-impregnated rubber instrument. The adhesive systems were Clearfil SE bond (CS), a two-step self-etch adhesive, and Xeno V (XE), a one-step self-etch adhesive. All NCCLs were restored with light-cured microhybrid resin composites (Z250). Restorations were evaluated at baseline and at 6, 12, 18, and 24 months by two blinded independent examiners using modified FDI criteria. The Fisher exact test and generalized estimating equation analysis considering repeated measurements were performed to compare the outcomes between the polishing systems and adhesives. Three restorations were dislodged: two in CS/Sof and one in CS/EP. None of the restorations required any repair or retreatment except those showing retention loss. Sof was superior to EP with regard to surface luster, staining, and marginal adaptation (p<0.05). CS and XE did not show differences in any criteria (p>0.05). Sof is clinically superior to EP for polishing performance in class V composite resin restoration. XE demonstrates clinically equivalent bonding performance to CS.

Using simulation pedagogy to teach clinical education skills: A randomized trial.

PubMed

Holdsworth, Clare; Skinner, Elizabeth H; Delany, Clare M

2016-05-01

Supervision of students is a key role of senior physiotherapy clinicians in teaching hospitals. The objective of this study was to test the effect of simulated learning environments (SLE) on educators' self-efficacy in student supervision skills. A pilot prospective randomized controlled trial with concealed allocation was conducted. Clinical educators were randomized to intervention (SLE) or control groups. SLE participants completed two 3-hour workshops, which included simulated clinical teaching scenarios, and facilitated debrief. Standard Education (StEd) participants completed two online learning modules. Change in educator clinical supervision self-efficacy (SE) and student perceptions of supervisor skill were calculated. Between-group comparisons of SE change scores were analyzed with independent t-tests to account for potential baseline differences in education experience. Eighteen educators (n = 18) were recruited (SLE [n = 10], StEd [n = 8]). Significant improvements in SE change scores were seen in SLE participants compared to control participants in three domains of self-efficacy: (1) talking to students about supervision and learning styles (p = 0.01); (2) adapting teaching styles for students' individual needs (p = 0.02); and (3) identifying strategies for future practice while supervising students (p = 0.02). This is the first study investigating SLE for teaching skills of clinical education. SLE improved educators' self-efficacy in three domains of clinical education. Sample size limited the interpretation of student ratings of educator supervision skills. Future studies using SLE would benefit from future large multicenter trials evaluating its effect on educators' teaching skills, student learning outcomes, and subsequent effects on patient care and health outcomes.

Gingival Unit Graft Versus Free Gingival Graft for Treatment of Gingival Recession: A Randomized Controlled Clinical Trial

PubMed Central

Jenabian, Niloofar; Bahabadi, Mohadese Yazdanpanah; Bijani, Ali; Rad, Morteza Rahimi

2016-01-01

Objectives: Gingival recession can lead to root exposure and discomfort for patients. There are various techniques for root coverage. The aim of this study was to compare the use of gingival unit graft (palatal graft including the marginal gingiva and papillae) with free gingival graft for treatment of localized gingival recession. Materials and Methods: In this randomized controlled clinical trial, 18 bilateral localized recessions of Miller class I and II were treated in nine systemically healthy patients. Recessions were randomly treated with gingival unit graft in one side and conventional free gingival graft in the other side. Clinical parameters including clinical attachment level, keratinized tissue width, probing depth and vertical recession depth (VRD) were recorded at baseline and at one, three and six months after surgery. The healing index and patient satisfaction were also evaluated. One-way and two-way repeated measures ANOVA and paired t-test were used for statistical analyses. Results: Both techniques caused significant improvement in clinical parameters. Gingival unit graft produced higher satisfaction esthetically (P=0.050, 0.024 and 0.024, respectively at the three time points), higher healing index (P<0.001), higher root coverage percentage at one month after surgery (34.04%, P=0.011) and greater reduction of recession width three months after surgery (P=0.007) but the reduction in VRD at this side was not significantly greater. Conclusions: Gingival unit graft might be an acceptable modality in Miller Class I/II recession defects. This technique may have advantages over free gingival graft such as significantly superior clinical and esthetic results. PMID:28392815

Conversion to IUI versus continuance with IVF in low responder patients: A systematic review.

PubMed

Fujii, Dennis T; Quesnell, Jodi L; Heitmann, Ryan J

2018-06-01

Poor response to ovarian hyper-stimulation can be difficult to predict prior to stimulation even when factoring in patient age and ovarian reserve testing. When faced with the situation of poor response, patients and providers have the difficult decision to proceed with oocyte retrieval, convert to intrauterine insemination (IUI), or cancel the cycle. Although this is not an uncommon scenario, there is little data available to assist with the counseling of these patients. We performed a systematic review of published studies comparing clinical pregnancy and live births between those patients continuing with in-vitro fertilization (IVF) and those converting to IUI. PubMed and Ovid were searched for all retrospective and randomized studies using the Keywords 'in-vitro fertilization', 'intrauterine insemination', 'poor responders', 'clinical pregnancy' and 'live birth rates'. A total of seven retrospective studies and one randomized control trial were reviewed. When evaluating poor responders as a group, six studies reported higher overall clinical pregnancy rates and five studies reported overall increased live birth rates with continuance of IVF. When stratified by the number of follicles produced, continuance of IVF demonstrated higher clinical pregnancy and live birth rates with ≥ 2 follicles. When only one follicle developed there were no significant differences in clinical pregnancy or live birth rates between the two groups. In patients undergoing IVF with ≤4 follicles, continuance with IVF may lead to higher clinical pregnancy and live birth compared to conversion to IUI except in patients with monofollicular development, although additional randomized controlled trials are needed to confirm these findings. Published by Elsevier B.V.

Xenogenous Collagen Matrix and/or Enamel Matrix Derivative for Treatment of Localized Gingival Recessions: A Randomized Clinical Trial. Part I: Clinical Outcomes.

PubMed

Sangiorgio, João Paulo Menck; Neves, Felipe Lucas da Silva; Rocha Dos Santos, Manuela; França-Grohmann, Isabela Lima; Casarin, Renato Corrêa Viana; Casati, Márcio Zaffalon; Santamaria, Mauro Pedrine; Sallum, Enilson Antonio

2017-12-01

Considering xenogeneic collagen matrix (CM) and enamel matrix derivative (EMD) characteristics, it is suggested that their combination could promote superior clinical outcomes in root coverage procedures. Thus, the aim of this parallel, double-masked, dual-center, randomized clinical trial is to evaluate clinical outcomes after treatment of localized gingival recession (GR) by a coronally advanced flap (CAF) combined with CM and/or EMD. Sixty-eight patients presenting one Miller Class I or II GRs were randomly assigned to receive either CAF (n = 17); CAF + CM (n = 17); CAF + EMD (n = 17), or CAF + CM + EMD (n = 17). Recession height, probing depth, clinical attachment level, and keratinized tissue width and thickness were measured at baseline and 90 days and 6 months after surgery. The obtained root coverage was 68.04% ± 24.11% for CAF; 87.20% ± 15.01% for CAF + CM; 88.77% ± 20.66% for CAF + EMD; and 91.59% ± 11.08% for CAF + CM + EMD after 6 months. Groups that received biomaterials showed greater values (P <0.05). Complete root coverage (CRC) for CAF + EMD was 70.59%, significantly superior to CAF alone (23.53%); CAF + CM (52.94%), and CAF + CM + EMD (51.47%) (P <0.05). Keratinized tissue thickness gain was significant only in CM-treated groups (P <0.05). The three approaches are superior to CAF alone for root coverage. EMD provides highest levels of CRC; however, the addition of CM increases gingival thickness. The combination approach does not seem justified.

Clinical efficacy of composite versus ceramic inlays and onlays: a systematic review.

PubMed

Fron Chabouis, Hélène; Smail Faugeron, Violaine; Attal, Jean-Pierre

2013-12-01

Large tooth substance losses are frequent in posterior teeth because of primary caries or aging restorations. Inlays and onlays are often the minimal invasive solution in such cases, but the efficacy of the composite and ceramic materials used is unknown. We performed a systematic review of randomized controlled trials comparing the efficacy of composite and ceramic inlays or onlays. MEDLINE, Embase and the Cochrane Central Register of Controlled Trials were searched without any restriction on date or language, as were references of eligible studies and ClinicalTrials.gov. Eligible studies were randomized trials comparing the clinical efficacy of composite to ceramic inlays or onlays in adults with any clinical outcome for at least 6 months. From 172 records identified, we examined reports of 2 randomized controlled trials involving 138 inlays (no onlays evaluated) in 80 patients and exhibiting a high-risk of bias. Outcomes were clinical scores and major failures. The 3-year overall failure risk ratio was 2 [0.38-10.55] in favor of ceramic inlays although not statistically significant. The reported clinical scores (United States Public Health Services and Californian Dental Association) showed considerable heterogeneity between trials and could not be combined. We have very limited evidence that ceramics perform better than composite material for inlays in the short term. However, this result may not be valid in the long term, and other trials are needed. Trials should follow Fédération dentaire internationale recommendations and enhance their methodology. Trials comparing composite and ceramic onlays are needed. Copyright © 2013 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Whose data set is it anyway? Sharing raw data from randomized trials.

PubMed

Vickers, Andrew J

2006-05-16

Sharing of raw research data is common in many areas of medical research, genomics being perhaps the most well-known example. In the clinical trial community investigators routinely refuse to share raw data from a randomized trial without giving a reason. Data sharing benefits numerous research-related activities: reproducing analyses; testing secondary hypotheses; developing and evaluating novel statistical methods; teaching; aiding design of future trials; meta-analysis; and, possibly, preventing error, fraud and selective reporting. Clinical trialists, however, sometimes appear overly concerned with being scooped and with misrepresentation of their work. Both possibilities can be avoided with simple measures such as inclusion of the original trialists as co-authors on any publication resulting from data sharing. Moreover, if we treat any data set as belonging to the patients who comprise it, rather than the investigators, such concerns fall away. Technological developments, particularly the Internet, have made data sharing generally a trivial logistical problem. Data sharing should come to be seen as an inherent part of conducting a randomized trial, similar to the way in which we consider ethical review and publication of study results. Journals and funding bodies should insist that trialists make raw data available, for example, by publishing data on the Web. If the clinical trial community continues to fail with respect to data sharing, we will only strengthen the public perception that we do clinical trials to benefit ourselves, not our patients.

Human intrabony defect regeneration with micro-grafts containing dental pulp stem cells: A randomized controlled clinical trial.

PubMed

Ferrarotti, Francesco; Romano, Federica; Gamba, Mara Noemi; Quirico, Andrea; Giraudi, Marta; Audagna, Martina; Aimetti, Mario

2018-05-19

The goal of this study was to evaluate if dental pulp stem cells (DPSCs) delivered into intrabony defects in a collagen scaffold would enhance the clinical and radiographic parameters of periodontal regeneration. In this randomized controlled trial, 29 chronic periodontitis patients presenting one deep intrabony defect and requiring extraction of one vital tooth were consecutively enrolled. Defects were randomly assigned to test or control treatments which both consisted of the use of minimally invasive surgical technique. The dental pulp of the extracted tooth was mechanically dissociated to obtain micro-grafts rich in autologous DPSCs. Test sites (n=15) were filled with micro-grafts seeded onto collagen sponge, whereas control sites (n=14) with collagen sponge alone. Clinical and radiographic parameters were recorded at baseline, 6 and 12 months postoperatively. Test sites exhibited significantly more PD reduction (4.9 mm versus 3.4 mm), CAL gain (4.5 versus 2.9 mm) and bone defect fill (3.9 versus 1.6 mm) than controls. Moreover, residual PD < 5 mm (93% versus 50%) and CAL gain ≥ 4 mm (73% versus 29%) was significantly more frequent in the test group. Application of DPSCs significantly improved clinical parameters of periodontal regeneration one year after treatment. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Evaluation of XIENCE V everolimus-eluting and Taxus Express2 paclitaxel-eluting coronary stents in patients with jailed side branches from the SPIRIT IV trial at 2 years.

PubMed

Forrest, John K; Lansky, Alexandra J; Meller, Stephanie M; Hou, Liming; Sood, Poornima; Applegate, Robert J; Wang, John C; Skelding, Kimberly A; Shah, Aakar; Kereiakes, Dean J; Sudhir, Krishnankutty; Cristea, Ecaterina; Yaqub, Manejeh; Stone, Gregg W

2013-06-01

The aim of this study was to determine whether patients from the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions (SPIRIT) IV trial who underwent percutaneous coronary intervention, who had target lesions with jailed side branches, had improved clinical outcomes when treated with the XIENCE V versus Taxus Express(2) drug-eluting stent. In the SPIRIT III randomized trial, patients with target lesions with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had lower 2-year rates of major adverse cardiac events. The SPIRIT IV trial represents a larger more diverse patient population compared with SPIRIT III. In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, 3,687 patients who underwent coronary stenting with up to 3 de novo native coronary artery lesions were randomized 2:1 to receive XIENCE V versus Taxus Express(2) stents. Two-year clinical outcomes of patients with or without jailed side branches after stenting were compared. A jailed side branch was defined as any side branch >1.0 mm in diameter within the target segment being stented, excluding bifurcations deemed to require treatment. Of the 3,687 patients in SPIRIT IV, a total of 1,426 had side branches that were jailed during angioplasty of the target lesion. Patients with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had significantly lower 2-year rates of target lesion failure (6.5% vs 11.9%, p = 0.001), major adverse cardiac events (6.6% vs 12.2%, p = 0.0008), ischemia-driven target vessel revascularization (4.1% vs 7.9%, p = 0.004), and stent thrombosis (0.6% vs 2.8%, p = 0.001). In conclusion, patients with jailed side branches after stenting with XIENCE V compared to Taxus Express(2) devices had superior clinical outcomes at 2 years in the large-scale randomized SPIRIT IV trial. Copyright © 2013 Elsevier Inc. All rights reserved.

The Effect of Insertion Torque on the Clinical Outcome of Single Implants: A Randomized Clinical Trial.

PubMed

Barone, Antonio; Alfonsi, Fortunato; Derchi, Giacomo; Tonelli, Paolo; Toti, Paolo; Marchionni, Saverio; Covani, Ugo

2016-06-01

The insertion torque value has been extensively used as an indicator for implant primary stability, which is considered a determining parameter for the implants success. The primary goal of the present randomized clinical trial was to evaluate and compare the clinical outcome for implants placed with high insertion torque (between 50 Ncm and 100 Ncm) and regular insertion torque (within 50 Ncm) in healed ridges. Partially edentulous patients, missing one or more mandibular or maxillary teeth, having an adequate amount of bone, requiring implant placement, were randomized to receive Blossom CT implants with regular insertion torque (<50 Ncm) or CT implants with high insertion torque (≥50 Ncm). Implants were left to heal submerged for 3 months. Implants were restored with individualized abutments and cemented metal-ceramic crowns. Acquired measurements were: insertion torque values (IT), thickness of buccal bone plate after implant osteotomy preparation (BBT), marginal bone level (MBL), and facial soft tissue level (FST). All patients were followed 12 months after implant placement. One hundred sixteen implants were placed in one hundred sixteen patients and enrolled for the study. Fifty-eight implants were randomly allocated in regular-IT and high-IT groups with a mean insertion torque ranging from 20 Ncm to 50 Ncm and from 50 Ncm to 100 Ncm, respectively. Three implants failed, and another five implants showed at the 12-month evaluation a marginal bone loss (ΔMBL) greater than 1.5 mm, being considered unsuccessful. The findings suggested that implants inserted with high-IT (≥50 Ncm) in healed bone ridges showed more peri-implant bone remodeling and buccal soft tissue recession than implants inserted with a regular-IT (<50 Ncm). Moreover, sites with a thick buccal bone wall (≥1 mm) - after implant osteotomy site preparation - seemed to be less prone to buccal soft tissue recession after 12 months than sites with a thin buccal bone wall (<1 mm). © 2015 Wiley Periodicals, Inc.

Evaluation of the Cochrane tool for assessing risk of bias in randomized clinical trials: overview of published comments and analysis of user practice in Cochrane and non-Cochrane reviews.

PubMed

Jørgensen, Lars; Paludan-Müller, Asger S; Laursen, David R T; Savović, Jelena; Boutron, Isabelle; Sterne, Jonathan A C; Higgins, Julian P T; Hróbjartsson, Asbjørn

2016-05-10

The Cochrane risk of bias tool for randomized clinical trials was introduced in 2008 and has frequently been commented on and used in systematic reviews. We wanted to evaluate the tool by reviewing published comments on its strengths and challenges and by describing and analysing how the tool is applied to both Cochrane and non-Cochrane systematic reviews. A review of published comments (searches in PubMed, The Cochrane Methodology Register and Google Scholar) and an observational study (100 Cochrane and 100 non-Cochrane reviews from 2014). Our review included 68 comments, 15 of which were categorised as major. The main strengths of the tool were considered to be its aim (to assess trial conduct and not reporting), its developmental basis (wide consultation, empirical and theoretical evidence) and its transparent procedures. The challenges of the tool were mainly considered to be its choice of core bias domains (e.g. not involving funding/conflicts of interest) and issues to do with implementation (i.e. modest inter-rater agreement) and terminology. Our observational study found that the tool was used in all Cochrane reviews (100/100) and was the preferred tool in non-Cochrane reviews (31/100). Both types of reviews frequently implemented the tool in non-recommended ways. Most Cochrane reviews planned to use risk of bias assessments as basis for sensitivity analyses (70 %), but only a minority conducted such analyses (19 %) because, in many cases, few trials were assessed as having "low" risk of bias for all standard domains (6 %). The judgement of at least one risk of bias domain as "unclear" was found in 89 % of included randomized clinical trials (1103/1242). The Cochrane tool has become the standard approach to assess risk of bias in randomized clinical trials but is frequently implemented in a non-recommended way. Based on published comments and how it is applied in practice in systematic reviews, the tool may be further improved by a revised structure and more focused guidance.

Comparison of the effects of sodium hyaluronate-chondroitin sulphate and corticosteroid in the treatment of lateral epicondylitis: a prospective randomized trial.

PubMed

Tosun, Haci Bayram; Gumustas, Seyitali; Agir, Ismail; Uludag, Abuzer; Serbest, Sancar; Pepele, Demet; Ertem, Kadir

2015-09-01

Hyaluronic acid and glycosaminoglycans have shown positive effects in improving lateral epicondylitis and other tendinosis conditions. Therefore, we designed a prospective, randomized study to compare the effects of a combined sodium hyaluronate and chondroitin sulfate (HA + CS) injection versus a triamcinolone injection in the treatment of lateral epicondylitis. In total, 57 consecutive patients with clinically diagnosed lateral epicondylitis were divided randomly into two groups. In the HA + CS group, 25 patients received a single injection of a solution containing an HA + CS combination and prilocaine HCl, while the 32 patients in the triamcinolone group received a single injection of a solution of triamcinolone and prilocaine HCl. We evaluated the pain and function outcome measures using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at the beginning of the study, and 3 and 6 months after the injection. Additionally, the Minimum Clinically Important Difference values and percentage changes in the PRTEE subscale scores between the assessments were calculated. No serious adverse events were reported throughout the study. The mean pain and function scores for the HA + CS and triamcinolone groups had significantly improved at 3 months, but the mean function scores in the HA + CS group were statistically significantly better when compared to the triamcinolone group. At 6 months, both groups had significantly improved mean pain and function scores, compared to the baseline scores; however, the mean pain and function scores in the 6-month HA + CS treatment group were better than in the 6-month triamcinolone group. The relative change for the mean total score in the HA + CS group was much better when compared with the triamcinolone group, and the HA + CS treatment group showed clinically significant improvement when compared with triamcinolone group at 3 and 6 months. This study supports the idea that for a single injection treatment of patients with lateral epicondylitis, a combination injection of HA + CS may offer better pain benefits for 6 months after injection, when compared to triamcinolone. Level II, Randomized Clinical Trial, Prospective Comparative Study.

Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial.

PubMed

Siewe, Jan; Bredow, Jan; Oppermann, Johannes; Koy, Timmo; Delank, Stefan; Knoell, Peter; Eysel, Peer; Sobottke, Rolf; Zarghooni, Kourosh; Röllinghoff, Marc

2014-09-05

The 360° fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine. But it changes the biomechanics of the spine and may cause adjacent segment disease (ASD). Among the many techniques developed to avoid this complication, one appears promising. It combines a rigid fusion with a flexible pedicle screw system (hybrid instrumentation, "topping off"). However, its clinical significance is still uncertain due to the lack of conclusive data. The study is a randomized, therapy-controlled, two-centre trial conducted in a clinical setting at two university hospitals. If they meet the criteria, outpatients presenting with degenerative disc disease, facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups: a control group undergoing conventional fusion surgery (PLIF - posterior lumbar intervertebral fusion), and an intervention group undergoing fusion surgery using a new flexible pedicle screw system (PLIF + "topping off"), which was brought on the market in 2013. Follow-up examination will take place immediately after surgery, after 6 weeks and after 6, 12, 24 and 36 months. An ongoing assessment will be performed every year.Outcome measurements will include quality of life and pain assessments using validated questionnaires (ODI - Ostwestry Disability Index, SF-36™ - Short Form Health Survey 36, COMI - Core Outcome Measure Index). In addition, clinical and radiologic ASD, sagittal balance parameters and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications (e.g. implant failure), adverse events, and serious adverse events will be monitored and documented throughout the study. New hybrid "topping off" systems might improve the outcome of lumbar spine fusion. But to date, there is a serious lack of and a great need of convincing data on safety or efficacy, including benefits and harms to the patients, of these systems. Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants. In such a case, randomized clinical trials are the best way to evaluate benefits and risks. NCT01852526.

The applications of regenerative medicine in sinus lift procedures: A systematic review.

PubMed

Correia, Francisco; Pozza, Daniel Humberto; Gouveia, Sónia; Felino, António; Faria E Almeida, Ricardo

2018-04-01

Findings in regenerative medicine applied to the sinus lift procedures. Evaluate the effectiveness of regenerative medicine in sinus lift. An extensive search for manuscripts were performed by using different combinations of keywords and MeSH terms (Pub-med; Embase; Scopus; Web of Science Core Collection; Medline; Current Contents Connect; Derwent Innovations Index; Scielo Citation Index; Cochrane library). The full text selected articles are written in English, Portuguese, Spanish, Italian, German, or French, and published until 28 of November 2016. Inclusion criteria were: implant osteointegration, radiographic, histologic, and/or histomorphometric analysis, clinical studies in humans using of regenerative medicine. This systematic review was performed by selecting only randomized controlled clinical trials and controlled clinical trials. Eighteen published studies (11 CT and 7 RCT) were considered eligible for inclusion in the present systematic review. These studies demonstrated considerable variation of biomaterial and cell technics used, study design, sinus lift technic, outcomes, follow-up, and results. Only few studies have demonstrated potential of regenerative medicine in sinus lift; further randomized clinical trials are needed to achieve more accurate results. © 2017 Wiley Periodicals, Inc.

The C-seal trial: colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler, a multi-center randomized controlled trial

PubMed Central

2012-01-01

Background Anastomotic leakage is a major complication in colorectal surgery and with an incidence of 11% the most common cause of morbidity and mortality. In order to reduce the incidence of anastomotic leakage the C-seal is developed. This intraluminal biodegradable drain is stapled to the anastomosis with a circular stapler and prevents extravasation of intracolonic content in case of an anastomotic dehiscence. The aim of this study is to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses, as assessed by anastomotic leakage leading to invasive treatment within 30 days postoperative. Methods The C-seal trial is a prospective multi-center randomized controlled trial with primary endpoint, anastomotic leakage leading to re-intervention within 30 days after operation. In this trial 616 patients will be randomized to the C-seal or control group (1:1), stratified by center, anastomotic height (proximal or distal of peritoneal reflection) and the intention to create a temporary deviating ostomy. Interim analyses are planned after 50% and 75% of patient inclusion. Eligible patients are at least 18 years of age, have any colorectal disease requiring a colorectal anastomosis to be made with a circular stapler in an elective setting, with an ASA-classification < 4. Oral mechanical bowel preparation is mandatory and patients with signs of peritonitis are excluded. The C-seal student team will perform the randomization procedure, supports the operating surgeon during the C-seal application and achieves the monitoring of the trial. Patients are followed for one year after randomization en will be analyzed on an intention to treat basis. Discussion This Randomized Clinical trial is designed to evaluate the effectiveness of the C-seal in preventing clinical anastomotic leakage. Trial registration NTR3080 PMID:23153188

Impact of red versus blue light on tolerability and efficacy of PDT: a randomized controlled trial.

PubMed

Gholam, Patrick; Bosselmann, Ina; Enk, Alexander; Fink, Christine

2018-06-01

Various light sources may be used for photodynamic therapy of actinic keratosis since photosensitizing agents are activated by different wavelengths. However, the relative impact of red and blue light irradiation on the efficacy and tolerability of therapy is controversial. The aim of this study is to compare the efficacy and tolerability of therapy with red versus blue light sources, as well as the patients' evaluation of cosmetic results, clinical response, painfulness and preferred light source for future photodynamic treatments. This is a prospective, single-center, randomized, controlled, open-label study with 28 patients undergoing elective photodynamic therapy. Red and blue light sources both showed very good results with a complete response rate of 84 % and 85 % respectively. Pain during photodynamic therapy was 6.1 vs. 5.4 (and 2.1 vs. 1.5 eight hours after therapy) on the visual analogue scale. Although these differences were statistically significant, the clinical relevance is low, since the number of therapy interruptions were equally distributed in both groups, and patients' subjective evaluation of the treatment showed no personal preference towards the light sources. Both light sources showed very good clinical results and satisfactory tolerability in this study. © 2018 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

The risk of elevated prolactin levels in pediatric patients exposed to antipsychotics for the treatment of schizophrenia and schizophrenia spectrum disorders: protocol for a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Antipsychotic medications, particularly second-generation antipsychotics, are increasingly being used to alleviate the symptoms of schizophrenia and other severe mental disorders in the pediatric population. While evidence-based approaches examining efficacy and safety outcomes have been reported, no review has evaluated prolactin-based adverse events for antipsychotic treatments in schizophrenia and schizophrenia spectrum disorders. Methods/design Searches involving MEDLINE, EMBASE, CENTRAL, PsycINFO, and clinical trial registries (ClinicalTrials.gov, Drug Industry Document Archive [DIDA], International Clinical Trials Registry Platform [ICTRP]) will be used to identify relevant studies. Two reviewers will independently screen abstracts and relevant full-text articles of the papers identified by the initial search according to the prospectively defined eligibility criteria. Data extraction will be conducted in duplicate independently. Pairwise random effects meta-analyses and network meta-analyses will be conducted on individual drug and class effects where appropriate. Discussion This systematic review will evaluate prolactin-based adverse events of first- and second-generation antipsychotics in the pediatric population with schizophrenia and schizophrenia spectrum disorders. It will also seek to strengthen the evidence base of the safety of antipsychotics by incorporating both randomized controlled trials and observational studies. Systematic review registration PROSPERO CRD42014009506 PMID:25312992

Efficacy and safety of adapalene gel 0.1% and 0.3% and tretinoin gel 0.05% for acne vulgaris: results of a single-center, randomized, double-blinded, placebo-controlled clinical trial on Mexican patients (skin type III-IV).

PubMed

Tirado-Sánchez, Andrés; Espíndola, Yareni Salas; Ponce-Olivera, Rosa María; Bonifaz, Alexandro

2013-06-01

The efficacy of topical retinoids is well known according to several clinical studies conducted predominantly among Caucasian patients. This study aimed to evaluate the efficacy and safety profile of adapalene and tretinoin among Mexican patients. To compare adapalene 0.1 and 0.3% and tretinoin 0.05% in Mexican subjects with acne vulgaris. We enrolled 171 patients in this single-center, randomized, double-blinded, placebo-controlled clinical trial. The patients applied on the face either adapalene 0.1%, adapalene 0.3%, tretinoin 0.05%, or placebo for 90 days and were evaluated for the reduction in total lesion counts and for the level of irritation. Tretinoin 0.05% and adapalene 0.3% were more effective than adapalene 0.1% and placebo in the reduction of both inflammatory and noninflammatory lesions. Most of adverse events to adapalene and many on tretinoin group were related to skin irritation, dry skin, scaling, pruritus, burning, and postinflammatory hyperpigmentation. Adapalene 0.3% and tretinoin 0.05% are comparable in efficacy, and adapalene 0.1% offers a better safety profile in Mexican patients. © 2013 Wiley Periodicals, Inc.

Infusion of solutions of pre-irradiated components in rats.

PubMed

Pappas, Georgina; Arnaud, Francoise; Haque, Ashraful; Kino, Tomoyuki; Facemire, Paul; Carroll, Erica; Auker, Charles; McCarron, Richard; Scultetus, Anke

2016-06-01

The objective of this study was to conduct a 14-day toxicology assessment for intravenous solutions prepared from irradiated resuscitation fluid components and sterile water. Healthy Sprague Dawley rats (7-10/group) were instrumented and randomized to receive one of the following Field IntraVenous Resuscitation (FIVR) or commercial fluids; Normal Saline (NS), Lactated Ringer's, 5% Dextrose in NS. Daily clinical observation, chemistry and hematology on days 1,7,14, and urinalysis on day 14 were evaluated for equivalence using a two sample t-test (p<0.05). A board-certified pathologist evaluated organ histopathology on day 14. Equivalence was established for all observation parameters, lactate, sodium, liver enzymes, creatinine, WBC and differential, and urinalysis values. Lack of equivalence for hemoglobin (p=0.055), pH (p=0.0955), glucose (p=0.0889), Alanine-Aminotransferase (p=0.1938), albumin (p=0.1311), and weight (p=0.0555, p=0.1896), was deemed not clinically relevant due to means within physiologically normal ranges. Common microscopic findings randomly distributed among animals of all groups were endocarditis/myocarditis and pulmonary lesions. These findings are consistent with complications due to long-term catheter use and suggest no clinically relevant differences in end-organ toxicity between animals infused with FIVR versus commercial fluids. Copyright © 2016 Elsevier GmbH. All rights reserved.

A new challenge in clinical research in childhood ALL: the prospective meta-analysis strategy for intergroup collaboration.

PubMed

Valsecchi, M G; Masera, G

1996-12-01

We consider the problems arising in clinical research on childhood acute lymphoblastic leukemia (ALL). Given the therapeutic progress achieved over the last few decades, any improvement in the outcome for the majority of children with ALL is difficult to assess with the usual size trials. Furthermore, the progress in genetics and molecular biology has now led to the identification of subgroups of children, typically with rare characteristics, for whom new treatments still await evaluation. For both these aspects of clinical research, there is an increasing need for international intergroup cooperation. After a discussion on the role of retrospective meta-analysis and randomized controlled trials in ALL research, we suggest that intergroup studies could be made more feasible, but still scientifically rigorous, by adopting a strategy of prospective meta-analysis. This strategy can be described as follows: i) different groups prospectively plan to ask the same randomized question within their protocols which may differ in other aspects, and to pool their data in order to evaluate treatment effect; ii) the management of the study can be de-centralized, by allowing each group to be responsible for conducting its own protocol. We would like to stimulate the debate on the methodological and practical aspects of research perspectives in ALL (and in pediatric oncology).

Acellular dermal matrix graft with or without enamel matrix derivative for root coverage in smokers: a randomized clinical study.

PubMed

Alves, Luciana B; Costa, Priscila P; Scombatti de Souza, Sérgio Luís; de Moraes Grisi, Márcio F; Palioto, Daniela B; Taba, Mario; Novaes, Arthur B

2012-04-01

The aim of this randomized controlled clinical study was to compare the use of an acellular dermal matrix graft (ADMG) with or without the enamel matrix derivative (EMD) in smokers to evaluate which procedure would provide better root coverage. Nineteen smokers with bilateral Miller Class I or II gingival recessions ≥3 mm were selected. The test group was treated with an association of ADMG and EMD, and the control group with ADMG alone. Probing depth, relative clinical attachment level, gingival recession height, gingival recession width, keratinized tissue width and keratinized tissue thickness were evaluated before the surgeries and after 6 months. Wilcoxon test was used for the statistical analysis at significance level of 5%. No significant differences were found between groups in all parameters at baseline. The mean gain recession height between baseline and 6 months and the complete root coverage favored the test group (p = 0.042, p = 0.019 respectively). Smoking may negatively affect the results achieved through periodontal plastic procedures; however, the association of ADMG and EMD is beneficial in the root coverage of gingival recessions in smokers, 6 months after the surgery. © 2012 John Wiley & Sons A/S.

Clinical evaluation of endometriosis and differential response to surgical therapy with and without application of Oxiplex/AP* adhesion barrier gel.

PubMed

diZerega, Gere S; Coad, James; Donnez, Jacques

2007-03-01

To correlate parameters of endometriosis obtained during routine clinical evaluation with the subsequent formation of adhesions following surgical treatment by laparoscopy. Randomized, controlled, double-blind, clinical trial. Tertiary referral centers for the treatment of endometriosis. Thirty-seven patients (65 with adnexa) with stage I-III endometriosis; endometrioma-only patients were excluded. Laparoscopic surgical treatment of endometriosis, followed by randomization to Oxiplex/AP (FzioMed, Inc., San Luis Obispo, California) gel treatment (treated group) of adnexa, or surgery alone (control group); follow-up laparoscopy 6-10 weeks later. Adnexal Americn Fertility Society score, correlated with color and location of endometriosis, as well as stage of disease determined by masked review of videotapes. Control patients with at least 50% red lesions had a greater increase in ipsilateral adnexal adhesion scores than patients with mostly black or white and/or clear lesions. Treated patients with red lesions had a greater decrease in adnexal adhesion scores than control patients. There was a correlation between baseline endometriosis stage and postoperative adhesion formation in control patients, but not treated patients. Patients with red endometriotic lesions had greater increases in their adhesion scores than patients with only black, white, and/or clear lesions. Oxiplex/AP gel was effective in reducing adhesions, compared to surgery alone, in all groups.