Gonçalves, Giulliano Peixoto; Barbosa, Fabiano Timbó; Barbosa, Luciano Timbó; Duarte, José Lira
A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. Our search found 185 original articles, of which 14 were randomized clinical trials. Only one original article (7.1%) showed good quality. There was no statistical significance between the collected data and the data shown in the hypothesis of this search. It can be concluded that in the sample of assessed articles 7% of the randomized clinical trials in intensive care published in a single intensive care journal in Brazil, present good methodological quality.
Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.
Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G
To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.
Savoca, Margaret R; Ludwig, David A; Jones, Stedman T; Jason Clodfelter, K; Sloop, Joseph B; Bollhalter, Linda Y; Bertoni, Alain G
To support claims that RCTs can reduce health disparities (i.e., are translational), it is imperative that methodologies exist to evaluate the tenability of external validity in RCTs when probabilistic sampling of participants is not employed. Typically, attempts at establishing post hoc external validity are limited to a few comparisons across convenience variables, which must be available in both sample and population. A Type 2 diabetes RCT was used as an example of a method that uses a geographic information system to assess external validity in the absence of a priori probabilistic community-wide diabetes risk sampling strategy. A geographic information system, 2009-2013 county death certificate records, and 2013-2014 electronic medical records were used to identify community-wide diabetes prevalence. Color-coded diabetes density maps provided visual representation of these densities. Chi-square goodness of fit statistic/analysis tested the degree to which distribution of RCT participants varied across density classes compared to what would be expected, given simple random sampling of the county population. Analyses were conducted in 2016. Diabetes prevalence areas as represented by death certificate and electronic medical records were distributed similarly. The simple random sample model was not a good fit for death certificate record (chi-square, 17.63; p=0.0001) and electronic medical record data (chi-square, 28.92; p<0.0001). Generally, RCT participants were oversampled in high-diabetes density areas. Location is a highly reliable "principal variable" associated with health disparities. It serves as a directly measurable proxy for high-risk underserved communities, thus offering an effective and practical approach for examining external validity of RCTs. Copyright © 2017 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
Al-Namankany, Abeer A; Ashley, Paul; Moles, David R; Parekh, Susan
Reporting of randomized controlled trials (RCTs) should be of high quality to support the conclusions reached by the authors. Poor-quality reporting has been associated with an overestimation in intervention efficacy. Within the field of paediatric dentistry, no study has assessed the quality of reporting. The aim of this study was to assess published RCTs in paediatric dental journals between 1985 and 2006 for: (i) whether quality of reporting allows readers to assess the validity of trials; and (ii) whether quality of reporting has improved since the introduction of the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Hand search of the main paediatric dentistry journals; inclusion criteria were: the trial was performed on children, and RCT. CONSORT guidelines were made into an operational checklist. Trials published between 1985 and 1997, and between 1998 and 2006 were compared to determine any improvement since the publication of the CONSORT guidelines. One hundred and seventy-three of 5635 articles met the inclusion criteria. Reporting quality was poor overall and showed heterogeneity. It had improved slightly since the publication of CONSORT. Few trials were reported adequately. The quality of reporting of clinical trials is poor, and often not adequate to allow readers to assess trial validity. Overall quality of reporting has not substantially improved since the publication of CONSORT.
Kruse, A Y; Kjaergard, L L; Krogsgaard, K
To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... the total attitude score (4.8 points) and the randomized clinical trials attitude subscale score (1.8 points). In conclusion, written information significantly improved outpatients' knowledge about and attitude toward randomized clinical trials. Detailed rather than brief information was more effective...
Full Text Available BACKGROUND: Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments. METHODS AND FINDINGS: We undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1 established blinding of patients or health care providers, (2 maintained the blinding of patients or health care providers, and (3 obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58% describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage, or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or
Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook
Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.
Jørgensen, L; Paludan-Müller, A. S.; Laursen, David
Background: 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. Methods: 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). Results: Our review included 68...... 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...
Meier, Ellen; Miller, Mary Beth; Lombardi, Nate; Leffingwell, Thad
Completion of alcohol assessments influences treatment outcomes, yet little is known about the aspects of assessment that may contribute to this response. The present study is a randomized controlled trial examining how the themes of alcohol assessments (e.g., assessment of alcohol-related consequences as opposed to drinking patterns) may affect drinking behaviors. Undergraduate students (N=290, Mage=19.97, SDage=1.81, 61.7% female), reporting at least one binge drinking episode during the past month, completed one of five baseline assessment batteries that varied thematically: (a) Control (e.g., minimal drinking quantity and frequency questions), (b) Consequences (e.g., College Alcohol Problems Scale; CAPS-r), (c) Norms (e.g., Drinking Norms Rating Form), (d) Diagnostic (e.g., Alcohol Use Disorders Identification Test), and (e) Combined (all themes). Participants completed a one-month follow-up of drinking quantity/frequency and the CAPS-r. All groups decreased their self-reported peak drinks consumed (palcohol-related consequences (p=0.06, ηp(2)=0.03) from baseline to follow-up. Minimal assessment of drinking quantity and frequency may result in assessment reactivity. Reductions in markers of risky drinking behaviors did not differ as a function of the type of assessments completed (e.g., Consequences vs Diagnostic). Continued research is needed to determine what other important variables (e.g., treatment seeking) may affect assessment reactivity. Copyright © 2016 Elsevier Ltd. All rights reserved.
Harris, Keith M; Goh, Melissa Ting-Ting
There is considerable debate on whether suicide assessment carries an iatrogenic risk for participants/patients. A double-blind randomized controlled trial (registration: R000022314) tested the emotional impact of suicide assessment on participants (n = 259) randomly assigned to experimental (n = 122) or control conditions (n = 137). The experimental condition included the Suicidal Affect-Behavior-Cognition Scale and intensive death-related questions, the control condition a quality of life scale. Both included measures of depression, social support and loneliness. Affective states were assessed immediately before and after testing, and research biases minimized. Post-test debriefing interviews collected qualitative reactions. Experimental participants ranged from nonsuicidal to highly suicidal. Between-groups ANCOVAs and repeated measures ANOVAs showed no differences by study condition, and no pre-post-test affect changes for either condition or suicidal participants (P > 0.10), supporting the null hypothesis of no iatrogenic effects. However, depressive participants in both conditions showed significant decreases in positive affect (P suicidality or other factors, predicted negative affect changes, which was supported by qualitative findings. Social desirability bias was also found in qualitative survey responses. No evidence of iatrogenic effects of suicide assessment were found. Recommendations are made to counter possible negative assessment effects on depressive participants/patients, and nurses and other caregivers are encouraged to talk to patients about suicidal symptoms. © 2016 Australian College of Mental Health Nurses Inc.
Mhaskar, Rahul; Djulbegovic, Benjamin; Magazin, Anja; Soares, Heloisa P.; Kumar, Ambuj
Objectives To assess whether reported methodological quality of randomized controlled trials (RCTs) reflect the actual methodological quality, and to evaluate the association of effect size (ES) and sample size with methodological quality. Study design Systematic review Setting Retrospective analysis of all consecutive phase III RCTs published by 8 National Cancer Institute Cooperative Groups until year 2006. Data were extracted from protocols (actual quality) and publications (reported quality) for each study. Results 429 RCTs met the inclusion criteria. Overall reporting of methodological quality was poor and did not reflect the actual high methodological quality of RCTs. The results showed no association between sample size and actual methodological quality of a trial. Poor reporting of allocation concealment and blinding exaggerated the ES by 6% (ratio of hazard ratio [RHR]: 0.94, 95%CI: 0.88, 0.99) and 24% (RHR: 1.24, 95%CI: 1.05, 1.43), respectively. However, actual quality assessment showed no association between ES and methodological quality. Conclusion The largest study to-date shows poor quality of reporting does not reflect the actual high methodological quality. Assessment of the impact of quality on the ES based on reported quality can produce misleading results. PMID:22424985
Gurusamy, K S; Gluud, C; Nikolova, D
BACKGROUND: Meta-analysis of randomized clinical trials (RCTs) with low risk of bias is considered the highest level of evidence available for evaluating an intervention. Bias in RCTs may overestimate or underestimate the true effectiveness of an intervention. METHODS: The causes of bias...... in surgical trials as described by The Cochrane Collaboration, and the methods that can be used to avoid them, are reviewed. RESULTS: Blinding is difficult in many surgical trials but careful trial design can reduce the bias risk due to lack of blinding. It is possible to conduct surgical trials with low risk...... of bias by using appropriate trial design. CONCLUSION: The risk of providing a treatment based on a biased effect estimate must be balanced against the difficulty of conducting trials with very low risk of bias. Better understanding of the risk of bias may result in improved trials with a closer estimate...
Siersma, V; Als-Nielsen, B; Chen, Weikeng
. Therefore, a stable multivariable method that allows for heterogeneity is needed for assessing the 'bias coefficients'. We present two general statistical models for analysis of a study of 523 randomized trials from 48 meta-analyses in a random sample of Cochrane reviews: a logistic regression model uses...
Full Text Available This paper suggests a method of evaluation of uncertainties in calculated transition probabilities by randomly varying parameters of an atomic code and comparing the results. A control code has been written to randomly vary the input parameters with a normal statistical distribution around initial values with a certain standard deviation. For this particular implementation, Cowan’s suite of atomic codes (R.D. Cowan, The Theory of Atomic Structure and Spectra, Berkeley, CA: University of California Press, 1981 was used to calculate radiative rates of magnetic-dipole and electric-quadrupole transitions within the ground configuration of titanium-like iron, Fe V. The Slater parameters used in the calculations were adjusted to fit experimental energy levels with Cowan’s least-squares fitting program, RCE. The standard deviations of the fitted parameters were used as input of the control code providing the distribution widths of random trials for these parameters. Propagation of errors through the matrix diagonalization and summation of basis state expansions leads to significant variations in the resulting transition rates. These variations vastly differ in their magnitude for different transitions, depending on their sensitivity to errors in parameters. With this method, the rate uncertainty can be individually assessed for each calculated transition.
Gonik, Nathan; Tassler, Andrew; Ow, Thomas J; Smith, Richard V; Shuaib, Stefan; Cohen, Hillel W; Sarta, Catherine; Schiff, Bradley A
American Society of Anesthesiology guidelines recommend preoperative fasts of 6 hours after light snacks and 8 hours after large meals. These guidelines were designed for healthy patients undergoing elective procedures but are often applied to intubated intensive care unit (ICU) patients. ICU patients undergoing routine procedures may be subjected to unnecessary prolonged fasts. This study tests whether shorter fasts allow for better nutrition delivery and patient outcomes without increasing the risk. Randomized blinded controlled trial. Tertiary academic medical center. ICU patients undergoing bedside tracheotomy. Intubated ICU patients who were receiving enteral feeding and for whom bedside tracheotomy was indicated were enrolled prospectively and randomly allocated to 2 parallel preoperative fasting regimens: a 6-hour fast (control) and a 45-minute fast (intervention). Patients were assessed for aspiration, caloric delivery, metabolic markers, and infectious and noninfectious complications. Twenty-four patients were enrolled and randomized. There were no complications related to the procedure. There were no cases of intraoperative aspiration identified. There was a single postoperative pneumonia in the control group. Median (interquartile range) length of fast and caloric delivery were significantly different between the control group and the shortened fast group: 22 hours (18, 34) vs 14 hours (5, 25; P < .001) and 429 kcal (57, 1125) vs 1050 kcal (825, 1410; P = .01), respectively. Shortening preoperative fasts in intubated ICU patients allowed for better caloric delivery in the preoperative period. © American Academy of Otolaryngology-Head and Neck Surgery Foundation 2015.
Keus, F; Wetterslev, J; Gluud, C
OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical...... of statistical method on inference. RESULTS: In seven meta-analyses of seven outcomes from 15 trials, there were zero-event trials in 0 to 71.4% of the trials. We found inconsistency in significance in one of seven outcomes (14%; 95% confidence limit 0.4%-57.9%). There was also considerable variability...... in the confidence limits, the intervention-effect estimates, and heterogeneity for all outcomes. CONCLUSIONS: The statistical method may influence the inference drawn from a meta-analysis that includes zero-event trials. Robustness assessments are needed to reduce bias in meta-analyses that include zero...
Kjaersgaard, Annette; Nielsen, Lars Hedemann; Sjölund, Bengt H.
OBJECTIVE: To examine whether patients assessed for initiation of oral intake only by Facial-Oral Tract Therapy had a greater risk of developing aspiration pneumonia during neurorehabilitation than patients assessed by Fibreoptic Endoscopic Evaluation of Swallowing. DESIGN: Randomized controlled ...
Partridge, J S L; Harari, D; Martin, F C; Peacock, J L; Bell, R; Mohammed, A; Dhesi, J K
Increasing numbers of older patients are undergoing vascular surgery. Inadequate preoperative assessment and optimization may contribute to increased postoperative morbidity and mortality. Patients aged at least 65 years scheduled for elective aortic aneurysm repair or lower-limb arterial surgery were enrolled in an RCT of standard preoperative assessment or preoperative comprehensive geriatric assessment and optimization. Randomization was stratified by sex and surgical site (aorta/lower limb). Primary outcome was length of hospital stay. Secondary outcome measures included new medical co-morbidities, postoperative medical or surgical complications, discharge to a higher level of dependency and 30-day readmission rate. A total of 176 patients were included in the final analysis (control 91, intervention 85). Geometric mean length of stay was 5·53 days in the control group and 3·32 days in the intervention group (ratio of geometric means 0·60, 95 per cent c.i. 0·46 to 0·79; P < 0·001). There was a lower incidence of delirium (11 versus 24 per cent; P = 0·018), cardiac complications (8 versus 27 per cent; P = 0·001) and bladder/bowel complications (33 versus 55 per cent; P = 0·003) in the intervention group compared with the control group. Patients in the intervention group were less likely to require discharge to a higher level of dependency (4 of 85 versus 12 of 91; P = 0·051). In this study of patients aged 65 years or older undergoing vascular surgery, preoperative comprehensive geriatric assessment was associated with a shorter length of hospital stay. Patients undergoing assessment and optimization had a lower incidence of complications and were less likely to be discharged to a higher level of dependency. Registration number: ISRCTN23142588 (http://www.controlled-trials.com). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.
Randomized trials have experienced a marked surge in endorsement and popularity in education research in the past decade. This surge reignited paradigm debates and spurred qualitative critics to accuse these experimental designs of eclipsing qualitative research. This article reviews a current iteration of this debate and examines two randomized…
Silverman, Henry J; Miller, Franklin G
Ethical concern has been raised with critical care randomized controlled trials in which the standard of care reflects a broad range of clinical practices. Commentators have argued that trials without an unrestricted control group, in which standard practices are implemented at the discretion of the attending physician, lack the ability to redefine the standard of care and might expose subjects to excessive harms due to an inability to stop early. To develop a framework for analyzing control group selection for critical care trials. Ethical analysis. A key ethical variable in trial design is the extent with which the control group adequately reflects standard care practices. Such a control group might incorporate either the "unrestricted" practices of physicians or a protocol that specifies and restricts the parameters of standard practices. Control group selection should be determined with respect to the following ethical objectives of trial design: 1) clinical value, 2) scientific validity, 3) efficiency and feasibility, and 4) protection of human subjects. Because these objectives may conflict, control group selection will involve trade-offs and compromises. Trials using a protocolized rather than an unrestricted standard care control group will likely have enhanced validity. However, if the protocolized control group lacks representativeness to standard care practices, then trials that use such groups will offer less clinical value and could provide less assurance of protecting subjects compared with trials that use unrestricted control groups. For trials evaluating contrasting strategies that do not adequately represent standard practices, use of a third group that is more representative of standard practices will enhance clinical value and increase the ability to stop early if needed to protect subjects. These advantages might come at the expense of efficiency and feasibility. Weighing and balancing the competing ethical objectives of trial design should be
Holliday, Emma B.; Nail, Lillian M.; Lyons, Karen S.; Hribar, Michelle R.; Thomas, Charles R.
Purpose Computer-based, patient-reported symptom survey tools have been described for patients undergoing chemotherapy. We hypothesized that patients undergoing radiotherapy might also benefit, so we developed a computer application to acquire symptom ratings from patients and generate summaries for use at point of care office visits and conducted a randomized-controlled pilot trial to test its feasibility. Methods Subjects were randomized prior to beginning radiotherapy. Both control and intervention group subjects completed the computerized symptom assessment, but only for the intervention group were printed symptom summaries made available before each weekly office visit. Metrics compared included the Global Distress Index (GDI), concordance of patient-reported symptoms and symptoms discussed by the physician and numbers of new and/or adjusted symptom management medications prescribed. Results 112 patients completed the study: 54 in the control and 58 in the intervention arms. There were no differences in GDI over time between the control and intervention groups. In the intervention group, more patient-reported symptoms were actually discussed in radiotherapy office visits: 46/202 vs. 19/230. A sensitivity analysis to account for within-subjects correlation yielded 23.2% vs. 10.3% (p=.03). Medications were started or adjusted at 15.4% (43/280) of control visits compared to 20.4% (65/319) of intervention visits (p=.07). Conclusions This computer application is easy to use and makes extensive patient-reported outcome data available at the point of care. Although no differences were seen in symptom trajectory, patients who had printed symptom summaries had improved communication during office visits and a trend towards more active symptom management during radiotherapy. PMID:26471280
Krupat, Edward; Richards, Jeremy B; Sullivan, Amy M; Fleenor, Thomas J; Schwartzstein, Richard M
Case-based collaborative learning (CBCL) is a novel small-group approach that borrows from team-based learning principles and incorporates elements of problem-based learning (PBL) and case-based learning. CBCL includes a preclass readiness assurance process and case-based in-class activities in which students respond to focused, open-ended questions individually, discuss their answers in groups of 4, and then reach consensus in larger groups of 16. This study introduces CBCL and assesses its effectiveness in one course at Harvard Medical School. In a 2013 randomized controlled trial, 64 medical and dental student volunteers were assigned randomly to one of four 8-person PBL tutorial groups (control; n = 32) or one of two 16-person CBCL tutorial groups (experimental condition; n = 32) as part of a required first-year physiology course. Outcomes for the PBL and CBCL groups were compared using final exam scores, student responses to a postcourse survey, and behavioral coding of portions of video-recorded class sessions. Overall, the course final exam scores for CBCL and PBL students were not significantly different. However, CBCL students whose mean exam performance in prior courses was below the participant median scored significantly higher than their PBL counterparts on the physiology course final exam. The most common adjectives students used to describe CBCL were "engaging," "fun," and "thought-provoking." Coding of observed behaviors indicated that individual affect was significantly higher in the CBCL groups than in the PBL groups. CBCL is a viable, engaging, active learning method. It may particularly benefit students with lower academic performance.
Simone Ferreira Borges Matsumoto
Full Text Available Background: Chemomechanical removal of carious lesions consists of the dissolution of carious tissue by the application of a natural or synthetic agent, followed by atraumatic mechanical removal. Aim: The aim of the present study was to assess the effectiveness of Papacarie Duo ® gel in the chemomechanical removal of carious lesions in primary teeth in comparison to the traditional method (low-speed bur. Settings and Design: A randomized clinical trial was conducted with 20 children between 5 and 8 years of age. Materials and Methods: Two teeth were treated in each child (split-mouth design, with the randomization of two methods: Group 1 - chemomechanical caries removal with Papacarie Duo™; and Group 2 - removal of carious dentin tissue using a low-speed bur. Both methods involved restoration with glass ionomer cement and follow up. The following aspects were evaluated: time required for the procedure; pain (face evaluation scale; rtention of the restorative material in the cavity; and the presence of secondary caries after 30 days. Statistical Analysis Used: Chi-squared test, Student′s t-test, and Wilcoxon test. Results: No statistically significant differences between methods were found regarding time required for the procedure (P = 0.13, the occurrence of pain (P = 0.585, or restoration status at the 30-day clinical evaluation (P = 0.713. Conclusion: The findings of the present study demonstrate that the two methods achieve similar results. The advantages of minimally invasive treatment, such as chemomechanical caries removal with Papacarie Duo™, are its ease of use, patient comfort, and the fact that it causes less damage to dental tissue.
Jenkins, Melissa M.; Youngstrom, Eric A.
Objective This study examined the efficacy of a new cognitive debiasing intervention in reducing decision-making errors in the assessment of pediatric bipolar disorder (PBD). Method The study was a randomized controlled trial using case vignette methodology. Participants were 137 mental health professionals working in different regions of the US (M=8.6±7.5 years of experience). Participants were randomly assigned to a (1) brief overview of PBD (control condition), or (2) the same brief overview plus a cognitive debiasing intervention (treatment condition) that educated participants about common cognitive pitfalls (e.g., base-rate neglect; search satisficing) and taught corrective strategies (e.g., mnemonics, Bayesian tools). Both groups evaluated four identical case vignettes. Primary outcome measures were clinicians’ diagnoses and treatment decisions. The vignette characters’ race/ethnicity was experimentally manipulated. Results Participants in the treatment group showed better overall judgment accuracy, p < .001, and committed significantly fewer decision-making errors, p < .001. Inaccurate and somewhat accurate diagnostic decisions were significantly associated with different treatment and clinical recommendations, particularly in cases where participants missed comorbid conditions, failed to detect the possibility of hypomania or mania in depressed youths, and misdiagnosed classic manic symptoms. In contrast, effects of patient race were negligible. Conclusions The cognitive debiasing intervention outperformed the control condition. Examining specific heuristics in cases of PBD may identify especially problematic mismatches between typical habits of thought and characteristics of the disorder. The debiasing intervention was brief and delivered via the Web; it has the potential to generalize and extend to other diagnoses as well as to various practice and training settings. PMID:26727411
Faizi, Fakhrudin; Tavallaee, Abbas; Rahimi, Aboulfazl; Saburi, Amin; Saghafinia, Masoud
Keeping in mind the burden of psychotherapy can play a crucial role concerning chronic pain (CP). Psychotherapy techniques are widely used to relief Chronic Pain (CP) worldwide. Appling psychotherapy needs to consider both individual and popular cultures. In addition to international requirements; nation-wide legitimacy should be regarded too. Psychological methods have provided a lot of articles in Iran, but they were neglected by the reviewers because the documents only have abstracts in English. The current study aimed to assess all Farsi Randomized Control Trials (RCTs) addressing psychotherapy to relieve chronic pains. Six nation-wide medical databases were investigated in 2012 using the keyword chronic pain in the Abstracts, systematically. Appling PICO question format (patient problem or population, intervention, comparison, and outcomes) all the interventional studies were reviewed for eligibility. Retrieving full text (in Farsi) and making the articles indistinguishable, two native reviewers assessed the quality of the articles independently using Jadad scale. Inclusion criteria met 1542 abstracts. After refining and excluding, seventeen experimental studies were retrieved and evaluated. Mean quality score of Jadad was 1.53 ± 1.37 (median = 1.0). Cognitive Behavior Therapy (CBT) was the dominant approach (11 out of 17) and the majority (6 out of 17 studies) of the treated cases was Low Back Pain (LBP). Patient-therapist gender adjustment has clearly reported in most of the studies, based on the requirements. Cognitive Behavior Therapy was more effective than the other psychotherapy approaches relieving chronic pain in the studies. Well-designed studies and comprehensive clarification of the studies demonstrating groups, intervention, follow-up and drop outs can improve the quality of the RCTs.
Samaan, Zainab; Schulze, Karleen M; Middleton, Catherine; Irvine, Jane; Joseph, Phillip; Mente, Andrew; Shah, Baiju R; Pare, Guillaume; Desai, Dipika
Background People of South Asian origin suffer a high burden of premature myocardial infarction (MI). South Asians form a growing proportion of the Canadian population and preventive strategies to mitigate the risk of MI in this group are needed. Prior studies have shown that multimedia interventions are effective and feasible in inducing health behavior changes among the obese, smokers, and among those who are sedentary. Objective Among at-risk South Asians living in Canada, our objectives are to determine: (1) the feasibility of a culturally tailored multimedia intervention to induce positive behavioral changes associated with reduced MI risk factors, and (2) the effectiveness and acceptability of information communicated by individualized MI and genetic risk score (GRS) reports. Methods The South Asian HeArt Risk Assessment (SAHARA) pilot study enrolled 367 individuals of South Asian origin recruited from places of worship and community centers in Ontario, Canada. MI risk factors including the 9p21 genetic variant status were provided to all participants after the baseline visit. Participants were randomly allocated to receive a multimedia intervention or control. The intervention group selected health goals and received personalized health messages to promote adherence to their selected goals. After 6 months, all participants had their MI risk factors repeated. The methods and results of this study are reported based on the CONSORT-EHEALTH guidelines. Results The mean age of participants was 53.8 years (SD 11.4), 52.0% (191/367) were women, and 97.5% (358/367) were immigrants to Canada. The mean INTERHEART risk score was 13.0 (SD 5.8) and 73.3% (269/367) had one or two copies of the risk allele for the 9p21 genetic variant. Both the intervention and control groups made some progress in health behavior changes related to diet and physical activity over 6 months. Participants reported that their risk score reports motivated behavioral changes, although half of
Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.
Aviles, Agustin, E-mail: firstname.lastname@example.org [Oncology Research Unit, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Neri, Natividad [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Fernandez, Raul [Department of Radiation Therapy, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Huerta-Guzman, Judith; Nambo, Maria J. [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico)
Purpose: We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14). Methods and Materials: Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group). Results: The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated. Discussion: Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis. Conclusions: The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.
Partridge, J S L; Harari, D; Martin, Finbarr; Peacock, J L; Bell, R; Mohammed, A.; Dhesi, J K
BACKGROUND: Increasing numbers of older patients are undergoing vascular surgery. Inadequate preoperative assessment and optimization may contribute to increased postoperative morbidity and mortality.METHODS: Patients aged at least 65 years scheduled for elective aortic aneurysm repair or lower-limb arterial surgery were enrolled in an RCT of standard preoperative assessment or preoperative comprehensive geriatric assessment and optimization. Randomization was stratified by sex and surgical s...
It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the
Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore
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
Carlson, Susan E; Gajewski, Byron J; Valentine, Christina J; Rogers, Lynette K; Weiner, Carl P; DeFranco, Emily A; Buhimschi, Catalin S
Preterm birth contributes to 0.5 million deliveries in the United States (one of eight pregnancies) and poses a huge burden on public health with costs in the billions. Of particular concern is that the rate of earliest preterm birth (DHA) supplementation provides a potential high yield, low risk strategy to reduce early preterm delivery in the US by up to 75%. We propose a Phase III Clinical Trial (randomized to low or high dose DHA, double-blinded) to examine the efficacy and safety of high dose DHA supplementation to reduce ePTB. We also plan for a secondary pregnancy efficacy analysis to determine if there is a subset of pregnancies most likely to benefit from DHA supplementation. Between 900 and 1200 pregnant women who are ≥ 18 years old and between 12 and 20 weeks gestation will be recruited from three trial experienced academic medical institutions. Participants will be randomly assigned to two daily capsules of algal oil (totaling 800 mg DHA) or soybean and corn oil (0 mg DHA). Both groups will receive a commercially available prenatal supplement containing 200 mg DHA. Therefore, the experimental group will receive 1000 mg DHA/d and the control group 200 mg DHA/d. We will then employ a novel Bayesian response adaptive randomization design that assigns more subjects to the "winning" group and potentially allows for substantially smaller sample size while providing a stronger conclusion regarding the most effective group. The study has an overall Type I error rate of 5% and a power of 90%. Participants are followed throughout pregnancy and delivery for safety and delivery outcomes. We hypothesize that DHA will decrease the frequency of ePTB <34 weeks. Reducing ePTB is clinically important as these earliest preterm deliveries carry the highest risk of neonatal morbidity, as well as contribute significant stress for families and post a large societal burden. This trial was registered with ClinicalTrials.gov (identifier: NCT02626299 ) on December 8
Delrieu, Isabelle; Leboulleux, Didier; Ivinson, Karen; Gessner, Bradford D
Vaccines interrupting Plasmodium falciparum malaria transmission targeting sexual, sporogonic, or mosquito-stage antigens (SSM-VIMT) are currently under development to reduce malaria transmission. An international group of malaria experts was established to evaluate the feasibility and optimal design of a Phase III cluster randomized trial (CRT) that could support regulatory review and approval of an SSM-VIMT. The consensus design is a CRT with a sentinel population randomly selected from defined inner and buffer zones in each cluster, a cluster size sufficient to assess true vaccine efficacy in the inner zone, and inclusion of ongoing assessment of vaccine impact stratified by distance of residence from the cluster edge. Trials should be conducted first in areas of moderate transmission, where SSM-VIMT impact should be greatest. Sample size estimates suggest that such a trial is feasible, and within the range of previously supported trials of malaria interventions, although substantial issues to implementation exist. Copyright © 2015 Elsevier Ltd. All rights reserved.
-sum and the overall rating of VPC was 78%. Conclusions: Pooling data of speakers of different languages in the same trial and comparing speech outcome across trials seems possible if the assessment of speech concerns consonants and is confined to speech units that are phonetically similar across languages. Agreed......Objective: To present the methodology for speech assessment in the Scandcleft project and discuss issues from a pilot study. Design: Description of methodology and blinded test for speech assessment. Speech samples and instructions for data collection and analysis for comparisons of speech outcomes...... across five included languages were developed and tested. Participants and Materials: Randomly selected video recordings of 10 5-year-old children from each language (n = 50) were included in the project. Speech material consisted of test consonants in single words, connected speech, and syllable chains...
Full Text Available Abstract Background Cluster randomized trials (CRTs are increasingly used to assess the effectiveness of interventions to improve health outcomes or prevent diseases. However, the efficiency and consistency of using different analytical methods in the analysis of binary outcome have received little attention. We described and compared various statistical approaches in the analysis of CRTs using the Community Hypertension Assessment Trial (CHAT as an example. The CHAT study was a cluster randomized controlled trial aimed at investigating the effectiveness of pharmacy-based blood pressure clinics led by peer health educators, with feedback to family physicians (CHAT intervention against Usual Practice model (Control, on the monitoring and management of BP among older adults. Methods We compared three cluster-level and six individual-level statistical analysis methods in the analysis of binary outcomes from the CHAT study. The three cluster-level analysis methods were: i un-weighted linear regression, ii weighted linear regression, and iii random-effects meta-regression. The six individual level analysis methods were: i standard logistic regression, ii robust standard errors approach, iii generalized estimating equations, iv random-effects meta-analytic approach, v random-effects logistic regression, and vi Bayesian random-effects regression. We also investigated the robustness of the estimates after the adjustment for the cluster and individual level covariates. Results Among all the statistical methods assessed, the Bayesian random-effects logistic regression method yielded the widest 95% interval estimate for the odds ratio and consequently led to the most conservative conclusion. However, the results remained robust under all methods – showing sufficient evidence in support of the hypothesis of no effect for the CHAT intervention against Usual Practice control model for management of blood pressure among seniors in primary care. The
Reid, Christopher M; Ryan, Philip; Miles, Helen; Willson, Kristyn; Beilin, Laurence J; Brown, Mark A; Jennings, Garry L; Johnston, Colin I; Macdonald, Graham J; Marley, John E; McNeil, John J; Morgan, Trefor O; West, Malcolm J; Wing, Lindon M H
The characterization of blood pressure in treatment trials assessing the benefits of blood pressure lowering regimens is a critical factor for the appropriate interpretation of study results. With numerous operators involved in the measurement of blood pressure in many thousands of patients being screened for entry into clinical trials, it is essential that operators follow pre-defined measurement protocols involving multiple measurements and standardized techniques. Blood pressure measurement protocols have been developed by international societies and emphasize the importance of appropriate choice of cuff size, identification of Korotkoff sounds, and digit preference. Training of operators and auditing of blood pressure measurement may assist in reducing the operator-related errors in measurement. This paper describes the quality control activities adopted for the screening stage of the 2nd Australian National Blood Pressure Study (ANBP2). ANBP2 is cardiovascular outcome trial of the treatment of hypertension in the elderly that was conducted entirely in general practices in Australia. A total of 54 288 subjects were screened; 3688 previously untreated subjects were identified as having blood pressure >140/90 mmHg at the initial screening visit, 898 (24%) were not eligible for study entry after two further visits due to the elevated reading not being sustained. For both systolic and diastolic blood pressure recording, observed digit preference fell within 7 percentage points of the expected frequency. Protocol adherence, in terms of the required minimum blood pressure difference between the last two successive recordings, was 99.8%. These data suggest that adherence to blood pressure recording protocols and elimination of digit preferences can be achieved through appropriate training programs and quality control activities in large multi-centre community-based trials in general practice. Repeated blood pressure measurement prior to initial diagnosis and study
Francolini, Giulio; Thomsen, Mette S; Yates, Esben S
BACKGROUND AND PURPOSE: To report on a Quality assessment (QA) of Skagen Trial 1, exploring hypofractionation for breast cancer patients with indication for regional nodal radiotherapy. MATERIAL AND METHODS: Deviations from protocol regarding target volume delineations and dose parameters (Dmin......, Dmax, D98%, D95% and D2%) from randomly selected dose plans were assessed. Target volume delineation according to ESTRO guidelines was obtained through atlas based automated segmentation and centrally approved as gold standard (GS). Dice similarity scores (DSC) with original delineations were measured....... Dose parameters measured in the two delineations were reported to assess their dosimetric outcome. RESULTS: Assessment included 88 plans from 12 centres in 4 countries. DSC showed high agreement in contouring, 99% and 96% of the patients had a complete delineation of target volumes and organs at risk...
Badia, Teresa; Formiga, Francesc; Ferrer, Assumpta; Sanz, Héctor; Hurtos, Laura; Pujol, Ramón
Malnutrition is frequent among older people and is associated with morbi-mortality. The aim of the study is to assess the effectiveness of a multifactorial and multidisciplinary intervention in the nutritional status among the elderly. Randomized, single-blind, parallel-group, clinical trial conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat (Barcelona). Of 696 referred people, born in 1924, 328 subjects were randomized to an intervention group or a control group. The intervention model used an algorithm and was multifaceted for both the patients and their primary care providers. The main outcome was improvement in nutritional status assessed by Mini Nutritional Assessment (MNA). Data analyses were done by intention-to-treat. Two-year assessment was completed for 127 patients (77.4%) in the intervention group and 98 patients (59.7%) in the control group. In the adjusted linear mixed models for MNA, intervention showed no significant effect during all follow-up period with -0.21 (CI: - 0.96; 0.26). In subjects with nutritional risk (MNA ≤ 23.5/30) existed a tendency towards improvement in MNA score 1.13 (95% CI -0.48; 2.74) after 2 years. A universal multifactorial assessment and target intervention over a two year period in subjects at nutritional risk showed a tendency to improve nutrition but not in the rest of community-dwelling studied subjects. Cognitive impairment was an independent factor strongly associated with a decline in nutritional status. The clinical trial is registered as part of a US National Institutes of Health Clinical Trial: NCT01141166.
Kahan, Brennan C.
Background Patient recruitment in clinical trials is often challenging, and as a result, many trials are stopped early due to insufficient recruitment. The re-randomization design allows patients to be re-enrolled and re-randomized for each new treatment episode that they experience. Because it allows multiple enrollments for each patient, this design has been proposed as a way to increase the recruitment rate in clinical trials. However, it is unknown to what extent recruitment could be incr...
Natalie L Rasgon
Full Text Available The objective of this study was to examine the effects of estrogen-based hormone therapy (HT on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5 at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+ or discontinue (HT- therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET. Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE-based HT, as well as women who continued conjugated equine estrogen (CEE-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE. Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease.ClinicalTrials.gov NCT00097058.
Shields, Lynn; Henderson, Victoria; Caslake, Robert
To assess the efficacy of comprehensive geriatric assessment (CGA) in prevention of delirium after hip fracture. Systematic review and metaanalysis. Ward based models on geriatrics wards and visiting team based models on orthopaedics wards were included. Four trials (three European, one U.S.; 973 participants) were identified. Two assessed ward-based, and two assessed team-based interventions. MEDLINE, EMBASE, CINAHL and PsycINFO databases; Clinicaltrials.gov; and the Central Register of Controlled Trials were searched. Reference lists from full-text articles were reviewed. Incidence of delirium was the primary outcome. Length of stay, delirium severity, institutionalization, long-term cognition and mortality were predefined secondary outcomes. Duration of delirium was included as a post hoc outcome. There was a significant reduction in delirium overall (relative risk (RR) = 0.81, 95% confidence interval (CI) = 0.69-0.94) in the intervention group. Post hoc subgroup analysis found this effect to be preserved in the team-based intervention group (RR = 0.77, 95% CI = 0.61-0.98) but not the ward-based group. No significant effect was observed on any secondary outcome. There was a reduction in the incidence of delirium after hip fracture with CGA. This is in keeping with results of non-randomized controlled trials and trials in other populations. Team-based interventions appeared superior in contrast to the Ellis CGA paper, but it is likely that heterogeneity in interventions and population studied affected this. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.
Kahan, Brennan C
Patient recruitment in clinical trials is often challenging, and as a result, many trials are stopped early due to insufficient recruitment. The re-randomization design allows patients to be re-enrolled and re-randomized for each new treatment episode that they experience. Because it allows multiple enrollments for each patient, this design has been proposed as a way to increase the recruitment rate in clinical trials. However, it is unknown to what extent recruitment could be increased in practice. We modelled the expected recruitment rate for parallel-group and re-randomization trials in different settings based on estimates from real trials and datasets. We considered three clinical areas: in vitro fertilization, severe asthma exacerbations, and acute sickle cell pain crises. We compared the two designs in terms of the expected time to complete recruitment, and the sample size recruited over a fixed recruitment period. Across the different scenarios we considered, we estimated that re-randomization could reduce the expected time to complete recruitment by between 4 and 22 months (relative reductions of 19% and 45%), or increase the sample size recruited over a fixed recruitment period by between 29% and 171%. Re-randomization can increase recruitment most for trials with a short follow-up period, a long trial recruitment duration, and patients with high rates of treatment episodes. Re-randomization has the potential to increase the recruitment rate in certain settings, and could lead to quicker and more efficient trials in these scenarios.
Østervig, R M; Sonne, A; Rasmussen, L S
starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...... the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... registered when it could be verified that patient enrolment was started after registration in a trial registry. RESULTS: We identified 200 RCTs. Dates for patient enrolment were not specified in 51 (25.5%). The proportion of correctly registered trials increased significantly from 17.1% (19/111) for trials...
Papageorgiou, Spyridon N; Kloukos, Dimitrios; Petridis, Haralampos; Pandis, Nikolaos
The objective of this study was to assess the risk of bias of randomized controlled trials (RCTs) published in prosthodontic and implant dentistry journals. The last 30 issues of 9 journals in the field of prosthodontic and implant dentistry (Clinical Implant Dentistry and Related Research, Clinical Oral Implants Research, Implant Dentistry, International Journal of Oral & Maxillofacial Implants, International Journal of Periodontics and Restorative Dentistry, International Journal of Prosthodontics, Journal of Dentistry, Journal of Oral Rehabilitation, and Journal of Prosthetic Dentistry) were hand-searched for RCTs. Risk of bias was assessed using the Cochrane Collaboration's risk of bias tool and analyzed descriptively. From the 3,667 articles screened, a total of 147 RCTs were identified and included. The number of published RCTs increased with time. The overall distribution of a high risk of bias assessment varied across the domains of the Cochrane risk of bias tool: 8% for random sequence generation, 18% for allocation concealment, 41% for masking, 47% for blinding of outcome assessment, 7% for incomplete outcome data, 12% for selective reporting, and 41% for other biases. The distribution of high risk of bias for RCTs published in the selected prosthodontic and implant dentistry journals varied among journals and ranged from 8% to 47%, which can be considered as substantial.
Nichols, Kelly K; Holland, Edward; Toyos, Melissa M; Peace, James H; Majmudar, Parag; Raychaudhuri, Aparna; Hamdani, Mohamed; Roy, Monica; Shojaei, Amir
To evaluate ocular comfort of lifitegrast ophthalmic solution 5.0% among patients with dry eye disease (DED) in the OPUS-3 trial. OPUS-3 was a multicenter, randomized, double-masked, placebo-controlled study. Adults with DED and recent artificial tear use were randomized 1:1 (lifitegrast:placebo) to ophthalmic drops twice daily for 84 days. On days 0 (baseline), 14, 42, and 84, drop comfort score (scale, 0-10; 0 = very comfortable, 10 = very uncomfortable) was measured at 0, 1, 2, and 3 minutes postinstillation. If the score was >3 at 3 minutes, assessment was repeated at 5, 10, and 15 minutes until score ≤3. Ocular treatment-emergent adverse events (TEAEs) were assessed. Overall, 711 participants were randomized (n=357 received lifitegrast; n=354 received placebo). Drop comfort scores for lifitegrast-treated participants improved within 3 minutes of instillation (mean scores on day 84 for both study and fellow eyes: instillation: lifitegrast, 3.4, placebo, 1.0; 3 minutes: lifitegrast, 1.5, placebo, 0.7). The majority (64%-66%) of participants had scores 3 at 3 minutes, the mean score in the lifitegrast group was similar to or better than that in the placebo group at 5, 10, or 15 minutes postinstillation. Lifitegrast appeared to be well tolerated, with ocular TEAEs rarely leading to discontinuation. In OPUS-3, lifitegrast appeared to be well tolerated and drop comfort scores approached placebo levels by 3 minutes postinstillation.
You, Young-Nim; Cho, Myung-Rae; Kim, Jae-Hong; Park, Ju-Hyung; Park, Gwang-Cheon; Song, Min-Yeong; Choi, Jin-Bong; Han, Jae-Young
This study was designed to assess the quality of reporting on randomized controlled trials (RCTs) of scalp acupuncture for the treatment of stroke. The following 8 databases were systematically investigated from their inception to December 2015: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, National Institute of Informatics Scholarly and Academic Information Navigator, National Digital Science Library, Korean Traditional Knowledge Portal, and Korean Studies Information Service System. RCTs utilizing scalp acupuncture as an intervention for stroke were selected, and the quality of reports was assessed based on the Consolidated Standards of Reporting Trials 2010 statement (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture 2010 (STRICTA). For each study, the overall quality score (OQS) of 13 CONSORT items, a combined key methodological index score (MIS) of 5 CONSORT items, and the OQS of 17 STRICTA items were measured. The original reports of 63 RCTs were ultimately obtained, and the median CONSORT OQS was 7 (minimum 2, maximum 11). Particularly, the items 'trial design', 'sample size', 'ancillary analyses', and 'harms' had a positive rate of less than 10%. The median MIS was 1 (minimum 0, maximum 5), with 'allocation concealment and implementation' and 'intent-to-treat analysis (ITT) analysis' having a positive rate of less than 10%. The median STRICTA OQS was 11 (minimum 6, maximum 14), and only the items 'sample size' and 'intent-to-treat analysis' were reported, with a positive rate of less than 10%. The mean CONSORT OQS increased by approximately 0.81 for each 5-year period in which manuscripts were published (95% confidence interval: 0.43 to 1.19; p scalp acupuncture treatment for stroke was moderate to low. Furthermore, reporting of some items was either insufficient or inadequate in the majority of studies. In order to improve and standardize the quality of RCTs investigating scalp acupuncture
Pennaforte, Thomas; Moussa, Ahmed; Loye, Nathalie; Charlin, Bernard; Audétat, Marie-Claude
Helping trainees develop appropriate clinical reasoning abilities is a challenging goal in an environment where clinical situations are marked by high levels of complexity and unpredictability. The benefit of simulation-based education to assess clinical reasoning skills has rarely been reported. More specifically, it is unclear if clinical reasoning is better acquired if the instructor's input occurs entirely after or is integrated during the scenario. Based on educational principles of the dual-process theory of clinical reasoning, a new simulation approach called simulation with iterative discussions (SID) is introduced. The instructor interrupts the flow of the scenario at three key moments of the reasoning process (data gathering, integration, and confirmation). After each stop, the scenario is continued where it was interrupted. Finally, a brief general debriefing ends the session. System-1 process of clinical reasoning is assessed by verbalization during management of the case, and System-2 during the iterative discussions without providing feedback. The aim of this study is to evaluate the effectiveness of Simulation with Iterative Discussions versus the classical approach of simulation in developing reasoning skills of General Pediatrics and Neonatal-Perinatal Medicine residents. This will be a prospective exploratory, randomized study conducted at Sainte-Justine hospital in Montreal, Qc, between January and March 2016. All post-graduate year (PGY) 1 to 6 residents will be invited to complete one SID or classical simulation 30 minutes audio video-recorded complex high-fidelity simulations covering a similar neonatology topic. Pre- and post-simulation questionnaires will be completed and a semistructured interview will be conducted after each simulation. Data analyses will use SPSS and NVivo softwares. This study is in its preliminary stages and the results are expected to be made available by April, 2016. This will be the first study to explore a new
Zonča, Pavel; Malý, Tomáš; Ihnát, Peter; Peteja, Matus; Kraft, Otakar; Kuca, Kamil
The aim of this study was to evaluate the quality of life and functional emptying of J-pouch versus Roux-en-Y reconstruction after total gastrectomy for malignancy. This study was designed as a prospective, nonblinded, randomized, parallel clinical trial (Trial Number: MN Ostrava, 200604). With informed consent, patients undergoing gastrectomy for malignancy were randomized to J-pouch or Roux-en-Y reconstruction. The time taken for a test semisolid meal labeled with 99mTc-sulfur colloid to exit the reconstructed parts was measured by dynamic scintigraphy 1 year after resection. Quality of life was measured using the Eypasch questionnaire at the same time as functional emptying assessment. This trial was investigator-initiated. In all, 72 patients were included into the study. The time taken for the test meal to exit the postgastrectomy reconstruction was 16.5±10.0 minutes (mean ± standard deviation) in the Roux-en-Y group and 89.4±37.8 minutes in the "J-pouch" group; the difference was statistically significant (PJ-pouch appeared to be a linear decreasing function compared to the exponential pattern seen in the Roux-en-Y group. The quality of life measurement showed scores of 106±18.8 points (mean ± standard deviation) in the Roux-en-Y group compared to 122±22.5 points in the J-pouch group; the difference was statistically significant (P=0.0016). There were no important adverse events. After total gastrectomy, a J-pouch reconstruction empties more slowly and is associated with higher quality of life compared to Roux-en-Y reconstruction. Whether these two observations have a direct causative link remains unanswered.
Full Text Available Background: The Consolidated Standards of Reporting Trials (CONSORT statement is a device to standardize reporting and improve the quality of controlled trials. However, little attention is paid to the statistical components in the CONSORT checklist. The present study evaluates the randomized controlled trials [RCTs] published in five high impact pharmacology journals with respect to its statistical methods. Methods: Randomized Controlled Trials [RCTs] published in the years 2013 & 2014 in five pharmacology journals with high impact factor, The Journal of Clinical Pharmacology (JCP, British Journal of Clinical Pharmacology (BJCP, European Journal of Clinical Pharmacology (EJCP, Journal of Pharmacology & Pharmacotherapeutics (JPP and Indian Journal of Pharmacology (IJP were assessed for adherence to the statistical components of CONSORT statement. Results: Of the 174 RCTs analysed, 103 described the method of sample size calculation. Of the five journals, maximum reports in JCP (34/50 and minimum in IJP (13/31 adhered to the CONSORT checklist [item 7a-sample size calculation]. Most reports mentioned the statistical methods used for analysis of data. (171/174 as per the checklist [item 12=statistical methods used]. Analysis of variance (ANOVA was the most commonly used test (88/174. The software used for statistical analysis was mentioned in 111 RCTs and SPSS was used more frequently (58/111. The exact p value was stated in 108 reports. Certain errors in statistical analysis were also noted (40/174. Conclusion: These findings show inconsistencies and non- adherence to the statistical components of the CONSORT statement especially with respect to sample size calculation. Special attention must be paid to the statistical accuracy of the reports.
Andersson, Daniel; Samuelsson, Kristian; Karlsson, Jón
The primary aim was to investigate and assess the current evidence of randomized controlled trials (RCTs) on anterior cruciate ligament (ACL) injuries, with special reference to the choice of surgical techniques and aspects of rehabilitation. A secondary aim was to clarify relative strengths and weaknesses of the selected studies, resolve literature conflicts, and finally, evaluate the need for further studies. A PubMed database search using the key words "anterior cruciate ligament" was performed. The search was limited to only RCTs published in English during the period of January 1995 to March 2009. Articles concerning surgical technique and rehabilitation were obtained. After initial screening and subsequent quality appraisal based on the CONSORT (Consolidated Standards of Reporting Trials) Statement, a total of 70 articles were included in this review. Initial graft tension and the use of a ligament augmentation device do not affect clinical outcome. Bioabsorbable screws and titanium screws produced equal clinical outcome, regardless of graft type. Radiographic signs of osteoarthritis develop in 50% of ACL-injured patients, regardless of treatment. Meniscectomy further increases the risk. Furthermore, the use of a postoperative knee brace does not affect the clinical outcome after ACL reconstruction. Closed kinetic chain exercises produced less pain and laxity while promoting better subjective outcome than open kinetic chain exercises after patellar tendon reconstruction. In terms of quality assessment, several weaknesses pertaining to study design were discovered among the included RCTs, which intelligibly stress the need for further high-quality studies. Level II, systematic review of RCTs.
Rosendal, Marianne; Olesen, Frede; Fink, Per
with a high score on rating scales for somatization were selected for follow-up (n=911). Follow-up was conducted 3 months (response rate=0.74) and 12 months (response rate=0.69) after inclusion using questionnaires measuring quality of life (Medical Outcomes Study 36-Item Short Form), disability days (WHO......OBJECTIVE: Our aim was to evaluate the effect of an educational program designed to improve care for somatizing patients in primary care. METHOD: Evaluation was performed during routine clinical care in a cluster randomized controlled trial. Patients were included consecutively, and those......'s Disability Assessment Schedule), somatization (Whiteley-7 and Symptom Checklist Somatic Symptom Scale) and patient satisfaction (European Project on Patient Evaluation of General Practice Care). We analyzed differences from baseline to follow-up and compared these for intervention and control groups. RESULTS...
Carlsson, Lars; Englund, Lars; Hallqvist, Johan; Wallman, Thorne
Abstract Objective To study the effects on sick leave from an early multidisciplinary assessment at a primary health care centre. Design Randomized controlled trial. Setting Patients who saw GPs at a primary health care centre in mid-Sweden and asked for a sickness certificate for psychiatric or musculoskeletal diagnoses were invited to participate. Patients included were sick-listed for less than four weeks; 33 patients were randomized either to an assessment within a week by a physiotherapi...
Stolle, C; Wolter, A; Roth, G; Rothgang, H
Deficits in quality, a lack of professional process management and, most importantly, neglect of outcome quality are criticized in long-term care. A cluster randomized, controlled trial was conducted to assess whether the Resident Assessment Instrument (RAI) can help to improve or stabilize functional abilities (ADL, IADL) and cognitive skills (MMST), improve quality of life (EQ-5D), and reduce institutionalization, thereby, increasing outcome quality. A total of 69 home care services throughout Germany were included and randomized. The treatment group (n = 36) received training in RAI and was supported by the research team during the study (13 months). Comparison of mean differences between the treatment and control groups (n = 33) showed no significant effect. Although the multilevel regression results show that clients in the treatment group fared better in terms of ADLs and IADLs (smaller decline) and were less likely to move to nursing homes and be hospitalized, none of these effects is significant. The lack of significance might result from the small number of clients included in the study. Moreover, RAI was not fully implemented and even partial implementation required more time than expected.
Kim, So Yun; Lee, Eun Jung; Jeon, Ju Hyun; Kim, Jung Ho; Jung, In Chul; Kim, Young Il
To assess the quality and completeness of published reports of randomized controlled trials (RCTs) of moxibustion. We searched six databases to retrieve eligible RCTs of moxibustion published from 2000 to December 2015. We used the STandards for Reporting Interventions in Clinical Trials of Moxibustion (STRICTOM) and Risk of Bias (ROB) tool to assess the completeness of reporting of RCTs of moxibustion and evaluate the reporting quality of included RCTs. Thirty-four studies of moxibustion were analyzed using STRICTOM and ROB. Of the 34 studies, the completeness percentage of STRICTOM varied from 33% to 100% (mean 68%, median 67%). The completeness of STRICTOM items showed a rising tendency along with the publication year. The STRICTOM items of setting and context (14.7%), rationale for the control (17.6%), and response (26.4%) showed incomplete reporting. The number of RCTs that rated a low risk of bias for allocation concealment (n=6), blinding of participants and personnel (n=1), and blinding of outcome assessment (n=4) appeared to be small. The quality of reporting of RCTs of moxibustion remains incomplete according to the STRICTOM and ROB tool at present. Researchers should consider the STRICTOM and ROB for improving not only the completeness of reporting but also the study design. General guidelines for RCTs of moxibustion are also required. Copyright © 2017. Published by Elsevier B.V.
Demirer, T; Dagli, M; Ilhan, O; Ayli, M; Haznedar, R; Fen, T; Gunel, N; Genc, Y; Arat, M; Ozcan, M; Arslan, O; Seyrek, E; Dincer, S; Ustun, T; Ustael, N; Koc, H; Muftuoglu, O; Akan, H
It is logical to expect that large-volume leukapheresis may be able to collect adequate numbers of PBSC with fewer procedures. To date, there is no agreement on the optimal volume of leukapheresis. Therefore, in this study we compared 8 l volume with 12 l and assessed whether a 50% increase in the blood volume processed would decrease the number of leukaphereses each patient needed to collect > or =2.5 x 10(6) CD34(+) cells/kg in normal mobilizers. PBSC mobilization was done with cyclophosphamide etoposide followed by rhG-CSF in all patients. Forty patients were randomized to undergo 8 l leukaphereses (n = 20 patients) or 12 l leukaphereses (n = 20). The median numbers of leukaphereses required in order to collect > or =2.5 x 10(6) CD34(+) cells/kg in patients processed with 8 l and 12 l were 1 (range 1-5) and 1 (1-4), respectively (P = 0.50). The median number of total nucleated cells (TNC) collected per patient was greater for the 12 l group (7.47 x 10(8)/kg vs 3.90 x 10(8)/kg, P < 0.001), as was the median number of total mononuclear cells (TMNC) (4.26 x 10(8)/kg vs 2.16 x 10(8)/kg, P < 0.001), whereas there was no difference between the two groups for the median number of CD34(+)cells collected per patient (8.94 x 10(6)/kg vs 8.60 x 10(6)/kg, P = 0.85). The TNCs and TMNCs collected per leukapheresis were again greater for the 12 l group (3.64 x 10(8)/kg vs 1.91 x 10(8)/kg, P = 0.001 and 2.17 x 10(8)/kg vs 0.88 x 10(8)/kg, P < 0.001), whereas there was no difference between the two groups for the median number of CD34(+) cells collected per leukapheresis (3.98 x 10(6)/kg vs 3.26 x 10(6)/kg, P = 0.90). This study showed that there is no difference between 8 l and 12 l volumes in regard to collected CD34(+) cells/kg and also the use of a 12 l leukapheresis volume did not decrease the number of leukaphereses performed compared with a 8 l leukapheresis volume. In fact, the use of the larger leukapheresis volume had the disadvantage of adding 60 min to the time the
milk, only an estimated one -fourth of neonates in India were breastfed within ... standard of care in India and mothers are informed about. 6 months of ... weeks postpartum. A random number sequence was generated using a com- puter program. Block randomization was used with a fixed block size of four. Concealment of ...
Ferrer, Assumpta; Formiga, Francesc; Sanz, Héctor; de Vries, Oscar J; Badia, Teresa; Pujol, Ramón
The purpose of this study was to assess the effectiveness of a multifactorial intervention to reduce falls among the oldest-old people, including individuals with cognitive impairment or comorbidities. A randomized, single-blind, parallel-group clinical trial was conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat (Barcelona). Of 696 referred people who were born in 1924, 328 were randomized to an intervention group or a control group. The intervention model used an algorithm and was multifaceted for both patients and their primary care providers. Primary outcomes were risk of falling and time until falls. Data analyses were by intention-to-treat. Sixty-five (39.6%) subjects in the intervention group and 48 (29.3%) in the control group fell during follow-up. The difference in the risk of falls was not significant (relative risk 1.28, 95% confidence interval [CI] 0.94-1.75). Cox regression models with time from randomization to the first fall were not significant. Cox models for recurrent falls showed that intervention had a negative effect (hazard ratio [HR] 1.46, 95% CI 1.03-2.09) and that functional impairment (HR 1.42, 95% CI 0.97-2.12), previous falls (HR 1.09, 95% CI 0.74-1.60), and cognitive impairment (HR 1.08, 95% CI 0.72-1.60) had no effect on the assessment. This multifactorial intervention among octogenarians, including individuals with cognitive impairment or comorbidities, did not result in a reduction in falls. A history of previous falls, disability, and cognitive impairment had no effect on the program among the community-dwelling subjects in this study.
Full Text Available ABSTRACTBackground: Thermogenic ingredients may play a role in weight management. In vitro and rodent work suggests that components of black pepper may impact energy expenditure, and in humans, other TPRV1 agonists e.g. capsaicin, augment EE. Objectives: To determine the impact of BP on 24-hour EE, respiratory quotient, and biochemical markers of metabolism and satiety, a randomized, controlled, cross-over study of black pepper (0.5mg/meal versus no pepper control was conducted in post-menopausal women. Subjects spent two 24-hour periods in a whole room indirect calorimeter. Results: Post-meal glucose, insulin, gut peptides and catecholamines were measured. Energy expenditure, respiratory quotient, or biochemical markers assessed did not differ significantly between the black pepper and no pepper control study days. Conclusions: Our findings do not support a role for black pepper in modulating energy expenditure in overweight postmenopausal women. Future work targeting alternative populations, administering black pepper in the fasted state, or in combination with other spices, may reveal the thermogenic effect of this spice.Trial registration: This trial was registered at clinicaltrials.gov (NCT01729143.Key words: Black pepper, piperine, energy expenditure, metabolic chamber
Richardson, Cliff; Brunton, Lisa; Olleveant, Nicola; Henson, David B; Pilling, Mark; Mottershead, Jane; Fenerty, Cecilia H; Spencer, Anne Fiona; Waterman, Heather
Adherence with therapy could influence the progression of glaucoma and ultimately affect the onset of visual impairment in some individuals. This feasibility study evaluated the measures to be used for a future randomized controlled trial assessing the effects of group-based education on adherence with eye drops. People diagnosed with glaucoma within the previous 12 months attending a regional ophthalmology clinic in the North West of England were recruited. A two-session education program delivered one week apart had been devised as part of a previous project. A combined adult learning and health needs approach to education was taken. Outcomes measured were knowledge of glaucoma, self-report of adherence, illness perception, beliefs about medicines, patient enablement, and general health (Short Form-12). Adherence was also measured objectively using a Medical Events Monitoring System device. Twenty-six participants consented to undertake the educational program and 19 produced analyzable data. Knowledge of glaucoma, illness perception, beliefs about medicine, and patient enablement all showed statistically significant improvements after education. Mean adherence with eye drops was maintained above 85% before and for 3 months after attendance at the educational program. Self-report exaggerated adherence by at least 10% when compared with the objective Medical Events Monitoring System data, and in fact the kappa agreement was zero. All questionnaires other than the Short Form-12 were considered to be valuable measures and use of a Medical Events Monitoring System device was considered to be an objective surrogate measure for adherence with eye drops. A multicenter, randomized, controlled equivalence trial of group versus individualized education using adherence as the primary outcome is the next step.
Danilo Maciel Carneiro
Full Text Available In this double-blind, randomized clinical trial, 36 healthy male volunteers were randomly distributed into three groups (n=12 that underwent a three-step treatment. For four consecutive days, we alternately administered a standardized dried extract of Equisetum arvense (EADE, 900 mg/day, placebo (corn starch, 900 mg/day, or hydrochlorothiazide (25 mg/day, separated by a 10-day washout period. Each volunteer served as his own control, and the groups’ results were compared. We repeated the same evaluation after each stage of treatment to evaluate the safety of the drug. The diuretic effect of EADE was assessed by monitoring the volunteers’ water balance over a 24 h period. The E. arvense extract produced a diuretic effect that was stronger than that of the negative control and was equivalent to that of hydrochlorothiazide without causing significant changes in the elimination of electrolytes. There was no significant increase in the urinary elimination of catabolites. Rare minor adverse events were reported. The clinical examinations and laboratory tests showed no changes before or after the experiment, suggesting that the drug is safe for acute use. Further research is needed to better clarify the mechanism of diuretic action and the other possible pharmacological actions of this phytomedicine.
Vidrine Damon J
Full Text Available Abstract Background Despite a significant decrease in smoking prevalence over the past ten years, cigarette smoking still represents the leading cause of preventable morbidity and mortality in the United States. Moreover, smoking prevalence is significantly higher among those with low levels of education and those living at, or below, the poverty level. These groups tend to be confronted with significant barriers to utilizing more traditional smoking cessation intervention approaches. The purpose of the study, Project ACTION (Adult smoking Cessation Treatment through Innovative Outreach to Neighborhoods, is to utilize a mobile clinic model, a network of community sites (i.e., community centers and churches and an interactive mobile messaging system to reach and deliver smoking cessation treatment to underserved, low-income communities. Methods/Design We are using a group-randomized design, with the community site as the sampling unit, to compare the efficacy of three smoking cessation interventions: 1 Standard Care - brief advice to quit smoking, nicotine replacement therapy (NRT, and self-help materials; 2 Enhanced Care - standard care components plus a cell phone-delivered text/graphical messaging component; and 3 Intensive Care - enhanced care components plus a series of 11 cell phone-delivered proactive counseling sessions. An economic evaluation will also be performed to evaluate the relative cost effectiveness of the three treatment approaches. We will recruit 756 participants (252 participants in each of the 3 intervention groups. At the time of randomization, participants complete a baseline assessment, consisting of smoking history, socio-demographic, and psychosocial variables. Monthly cell phone assessments are conducted for 6 months-post enrollment, and a final 12-month follow-up is conducted at the original neighborhood site of enrollment. We will perform mixed-model logistic regression to compare the efficacy of the three smoking
Kjaergard, L L; Nikolova, D; Gluud, C
Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998......-blinding. The median quality score of all trials was 3 points (range, 1-5 points). Multiple logistic regression analysis explored the association between quality and therapeutic areas, number of centers, external funding, year of publication, and country of origin. High-quality trials were most likely to investigate......, single-center trials, and trials with no external funding. Quality did not improve with time and was not associated with country of origin. The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers...
Kamioka, Hiroharu; Tsutani, Kiichiro; Maeda, Masaharu; Hayasaka, Shinya; Okuizum, Hiroyasu; Goto, Yasuaki; Okada, Shinpei; Kitayuguchi, Jun; Abe, Takafumi
The purpose of this study was to assess the quality of study reports on spa therapy based on randomized controlled trials by the spa therapy and balneotherapy checklist (SPAC), and to show the relationship between SPAC score and the characteristics of publication. We searched the following databases from 1990 up to September 30, 2013: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi Web, Global Health Library, the Western Pacific Region Index Medicus, PsycINFO, and the Cochrane Database of Systematic Reviews. We used the SPAC to assess the quality of reports on spa therapy and balneotherapy trials (SPAC) that was developed using the Delphi consensus method. Fifty-one studies met all inclusion criteria. Forty studies (78%) were about "Diseases of the musculoskeletal system and connective)". The total SPAC score (full-mark; 19 pts) was 10.8 ± 2.3 pts (mean ± SD). The items for which a description was lacking (very poor; spa facility where the data were collected"; "pH"; "scale of bathtub"; "presence of other facility and exposure than bathing (sauna, steam bath, etc.)"; "qualification and experience of care provider"; "Instructions about daily life" and "adherence". We clarified that there was no relationship between the publish period, languages, and the impact factor (IF) for the SPAC score. In order to prevent flawed description, SPAC could provide indispensable information for researchers who are going to design a research protocol according to each disease. Copyright © 2014 Elsevier Ltd. All rights reserved.
Wiles, C M; Newcombe, R G; Fuller, K J; Jones, A; Price, M
To determine to what degree assessment of mobility based on comparison of videotape recordings before and after courses of physiotherapy in patients with chronic multiple sclerosis (MS) is reliable, correlates with 'live' assessments and indicates benefit. Prospective data collection within a randomized crossover controlled trial of physiotherapy at home, as an outpatient, or 'no therapy' in 40 patients. Hospital outpatients: outpatient and home physiotherapy. Mobility change based on a comparison of short video recordings before and after each treatment period was scored independently by two physiotherapists blinded to therapy type and other measures of outcome. Scores were compared with changes in the Rivermead Mobility Index (RMI) and other indices assessed by a physiotherapist in the patient's home. The two video observers agreed substantially on patient outcome. Changes in walking based on video correlated with RMI for home treatment (r = 0.41, p = 0.008) but not for hospital or no treatment periods (r = 0.14 and 0.15): video changes correlated with the 'live' assessor's global change score inconsistently ('no therapy' r = 0.48, p = 0.002, hospital r = 0.30, p = 0.06 and home r = 0.17, p = 0.30 treatment periods). Based on video data alone, improved mobility was evident following home therapy for only one observer but not for the other or the averaged scores of both. There was substantial agreement between two observers deciding on change in mobility based on independent blinded evaluation of short video sequences. However the correlations of these with 'live' assessments were variable. Physiotherapy had a less clear benefit on mobility based on video analysis alone compared with 'live' assessments. The study highlights the need for more objective measures of habitual mobility over longer periods.
Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan
Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress
de Saeger, H.; Kamphuis, J.H.; Finn, S.E.; Smith, J.D.; Verheul, R.; van Busschbach, J.J.; Feenstra, D.J.; Dine, J.; Horn, E.K.
The field of clinical personality assessment is lacking in published empirical evidence regarding its treatment and clinical utility. This article reports on a randomized controlled clinical trial (N = 74) allocating patients awaiting treatment in a specialized clinic for personality disorders to
Smith, J J
The effectiveness of intravaginal electrical stimulation was compared to standard therapy in the treatment of genuine stress urinary incontinence and detrusor instability. A total of 57 women with urinary incontinence was evaluated with video urodynamics and voiding diaries before and after treatment. Of the women 18 with stress urinary incontinence were randomized to electrical stimulation or Kegel exercise and 38 with detrusor instability were randomized to anticholinergic therapy or electrical stimulation. Of patients using electrical stimulation in the stress urinary incontinence group 66% improved and 72% of the patients with detrusor instability treated with electrical stimulation improved. These rates were not statistically significant when compared to traditional therapy. Electrical stimulation is safe and at least as effective as properly performed Kegel and anticholinergic therapy in the treatment of stress urinary incontinence and detrusor instability.
Kennedy, S.; Jin, X.; Yu, H.; Zhong, S.; Magill, P.; Vliet, T. van; Kistemaker, C.; Voors, C.; Pasman, W.
A proof-of-concept study to assess the safety and efficacy of a traditional Chinese medicine formula as treatment for primary dysmenorrhea showed no statistically significant benefit over placebo. However, some efficacy parameters suggested possible superiority of the active treatment and so a
Eren, B; Onay, E O; Ungor, M
To evaluate three emergency procedures for their ability to alleviate clinical symptoms associated with symptomatic teeth having signs of (at least) partial irreversible pulpitis. Sixty-six maxillary and mandibular molars were randomly assigned to a total pulpectomy group (TP; n = 22), partial pulpectomy group (PP; n = 22) or pulpotomy group (P; n = 22). Procedure durations were recorded. Patients answered a questionnaire on daily analgesic requirements and about clinical symptoms (pain intensity, chewing sensitivity and thermal sensitivity) after the anaesthetic effect had disappeared (Day 0) and on Days 1, 3 and 7 post-treatment. The total pulpectomy group was associated with the longest procedures (median, 24 min), followed by the partial pulpectomy and pulpotomy groups (P pulpectomy group reported greater reductions in pain intensity than the pulpotomy group between Days 0 and 7, Days 1 and 3, and Days 1 and 7 (P pulpectomy and total pulpectomy were comparable with respect to relieving clinical symptoms. Pulpotomy may be preferred because it requires significantly less time and is a simple technique that relieves symptoms quickly and effectively. © 2017 International Endodontic Journal. Published by John Wiley & Sons Ltd.
pain perception was assessed using visual analog scale (VAS) scores at presentation and after delivery while maternal ... Randomized controlled trial of intramuscular pentazocine compared to intravenous paracetamol for pain relief in labour. 117. Tropical Journal of Obstetrics .... An envelope was opened by a nurse and.
Jurczak, I; Kowalski, J; Irzmański, R
It's known, controlled physical exercise which is a part of cardiac rehabilitation lead to positive changes in coronary circulation and contributes to minimizing other risk factors, such as lipid concentration in the blood or body weight as well as decreases the risk of another acute coronary disease. Monitoring cardiovascular activity is a necessary element of supervising the patient during cardiac rehabilitation. This supervision is primarily concerned with coronary circulation, bypassing the peripheral circulation which may seem like an important part of properly reacts to physical activity. The aim of the study was to evaluate changes in the peripheral circulation in the calf, induced by controlled physical exercise performed within a standard rehabilitation procedure in patients with acute coronary disease, with the use of impedance plethysmography. Clinical trial (CT). All the patients were referred to be cardiologically rehabilitated to the hospital in the Clinic of Internal Diseases and Cardiological Rehabilitation of the Medical University of Łodz not later than one month following the occurrence of acute coronary disease. Forty-seven patients with acute coronary disease were divided into two study groups. Group I (N.=23) participated in a two-week and Group II in a four-week cardiac rehabilitation. Forty-seven patients participated in interval training on a cycle ergometer and exercise improving general physical state held five times a week. All the patients underwent impedance plethysmography test before and after the training session in order to evaluate peripheral circulation in lower limbs. The authors of the study observed changes in plethysmographic parameters. After two weeks of performing physical exercise Group I demonstrated an increase in the following parameters: PSlope by 3.8%, PAmpl by 1.7%, CT by 3.3% and PT by 1% (p>0.05). With regards to Group II, the parameters increased respectively by: 23.8% (PSlope), 20.4% (PAmpl), 11.6% (CT) and 6
Cheng, Huai Yong
An estimated 1.5 million residents of nursing homes (NH) in the United States were prescribed an average of 7 to 8 medications each month. However, it is unknown which of these prescribed drugs and nutritional supplements have been tested for use among NH residents who often have distinct and complex needs compared with other geriatric patients. This pilot study addresses the quantity and quality of randomized, controlled drug and nutritional supplement trials that have been conducted among NH residents. Using multiple search strategies and review protocol, I assessed the quality of evidence from randomized, controlled drug and nutritional supplement trials that had a parallel-group design, were conducted among NH residents, and were published in English between 1968 and October 2004. Internal validity of the trials was examined by assessing adequately reporting power calculation, drop-outs (completion fraction), randomization and allocation concealment, blind status, and intention-to-treat analysis. External validity of the trials was examined by assessing adequately reporting the sample description, the inclusion and exclusion criteria, the recruitment process, and comorbidities and harm. Relatively few drug and nutritional supplements have been tested among NH residents by well-designed and executed randomized controlled trials (N = 42). The total number of participants (N = 7941) is small. The quality of many trials is poor. Given the limited number and poor quality of existing trials conducted among NH residents in this pilot study, I conclude that there is a limited body of evidence that could be used to establish quality of care standards or pay for performance criteria for drug therapy and nutritional supplements in NH. Long-term care providers face a great challenge in practicing evidence-based medicine in prescribing drugs and nutritional supplements.
Full Text Available Kelly K Nichols,1 Edward Holland,2 Melissa M Toyos,3 James H Peace,4 Parag Majmudar,5 Aparna Raychaudhuri,6 Mohamed Hamdani,6 Monica Roy,6 Amir Shojaei6 1School of Optometry, University of Alabama at Birmingham, Birmingham, AL, 2Cincinnati Eye Institute, Edgewood, KY, 3Toyos Clinic, Nashville, TN, 4United Medical Research Institute, Inglewood, CA, 5Chicago Cornea Consultants, Ltd., Hoffman Estates, IL, 6Shire, Lexington, MA, USA Purpose: To evaluate ocular comfort of lifitegrast ophthalmic solution 5.0% among patients with dry eye disease (DED in the OPUS-3 trial. Methods: OPUS-3 was a multicenter, randomized, double-masked, placebo-controlled study. Adults with DED and recent artificial tear use were randomized 1:1 (lifitegrast:placebo to ophthalmic drops twice daily for 84 days. On days 0 (baseline, 14, 42, and 84, drop comfort score (scale, 0–10; 0 = very comfortable, 10 = very uncomfortable was measured at 0, 1, 2, and 3 minutes postinstillation. If the score was >3 at 3 minutes, assessment was repeated at 5, 10, and 15 minutes until score ≤3. Ocular treatment-emergent adverse events (TEAEs were assessed. Results: Overall, 711 participants were randomized (n=357 received lifitegrast; n=354 received placebo. Drop comfort scores for lifitegrast-treated participants improved within 3 minutes of instillation (mean scores on day 84 for both study and fellow eyes: instillation: lifitegrast, 3.4, placebo, 1.0; 3 minutes: lifitegrast, 1.5, placebo, 0.7. The majority (64%–66% of participants had scores <3 within 3 minutes postinstillation on days 14, 42, and 84. In participants with scores >3 at 3 minutes, the mean score in the lifitegrast group was similar to or better than that in the placebo group at 5, 10, or 15 minutes postinstillation. Lifitegrast appeared to be well tolerated, with ocular TEAEs rarely leading to discontinuation. Conclusion: In OPUS-3, lifitegrast appeared to be well tolerated and drop comfort scores approached placebo
Full Text Available Assumpta Ferrer,1 Francesc Formiga,2,3 Héctor Sanz,4 Oscar J de Vries,5 Teresa Badia,6 Ramón Pujol2,3 On behalf of the OCTABAIX Study Group 1Primary Healthcare Centre "El Plà" CAP-I, Sant Feliu de Llobregat, 2Geriatric Unit, Internal Medicine Service, Hospital Universitari de Bellvitge, 3Bellvitge Biomedical Research Institute, IDIBELL, L'Hospitalet de Llobregat, 4Support Research Unit, Primary Health Department Costa Ponent, IDIAP Jordi Gol, Barcelona, Spain; 5Department of Internal Medicine, VU University Medical Center, Amsterdam, the Netherlands; 6Primary Healthcare Centre Martorell, Barcelona, Spain Background: The purpose of this study was to assess the effectiveness of a multifactorial intervention to reduce falls among the oldest-old people, including individuals with cognitive impairment or comorbidities. Methods: A randomized, single-blind, parallel-group clinical trial was conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat (Barcelona. Of 696 referred people who were born in 1924, 328 were randomized to an intervention group or a control group. The intervention model used an algorithm and was multifaceted for both patients and their primary care providers. Primary outcomes were risk of falling and time until falls. Data analyses were by intention-to-treat. Results: Sixty-five (39.6% subjects in the intervention group and 48 (29.3% in the control group fell during follow-up. The difference in the risk of falls was not significant (relative risk 1.28, 95% confidence interval [CI] 0.94–1.75. Cox regression models with time from randomization to the first fall were not significant. Cox models for recurrent falls showed that intervention had a negative effect (hazard ratio [HR] 1.46, 95% CI 1.03–2.09 and that functional impairment (HR 1.42, 95% CI 0.97–2.12, previous falls (HR 1.09, 95% CI 0.74–1.60, and cognitive impairment (HR 1.08, 95% CI 0.72–1.60 had no effect on the
Salvà, Antoni; Rojano, Xavier; Coll-Planas, Laura; Domènech, Sara; Roqué I Figuls, Marta
The Mini Falls Assessment Instrument (MFAI) identifies risk factors for falls in an individual and links them to specific interventions. This study evaluates the effectiveness of MFAI as the basis for a falls prevention strategy in institutionalized elderly. A cluster randomized clinical trial (identifier NCT00888953) was conducted in 16 nursing homes randomized to apply MFAI (intervention) or a modified version not linked to actions (control). The primary endpoint was the occurrence of falls during follow-up (12 months). Secondary variables were total number of falls, physical function, quality of life, functional status, and adverse effects. Data from 330 participants (197 intervention, 137 control) were analyzed. Both groups had a similar number of risk factors: 7 in the intervention group (range 1-12) and 8 (1-13) in the control group. In the intervention group there were more fallers (49% vs. 38%), and higher number of falls (315 vs. 109), and fall rate per 100 person-years (192.5 vs. 179.8) than the control group. In the multivariate analysis, there were no significant differences in fall risk (odds ratio=1.45; 95% confidence interval [CI]: .67 to 3.14; P=.350), but the incidence rate is significantly higher in the intervention group (Incidence rate ratio=2.23; 95% CI: 1.43 to 3.48; P<.001). The results on the efficacy of the MFAI as a fall prevention strategy are inconclusive. Additional studies are needed in order to provide good quality evidence. Copyright © 2014 SEGG. Published by Elsevier Espana. All rights reserved.
Martínez-Vizcaíno, Vicente; Sánchez-López, Mairena; Salcedo-Aguilar, Fernando; Notario-Pacheco, Blanca; Solera-Martínez, Montserrat; Moya-Martínez, Pablo; Franquelo-Morales, Pablo; López-Martínez, Sara; Rodríguez-Artalejo, Fernando
The MOVI physical activity program has been shown to reduce adiposity and to improve serum lipid profiles in schoolchildren. However, MOVI may have not achieved its maximum potential effectiveness, as increased physical activity on weekdays may have been offset by more sedentary behavior at weekends. We therefore developed the MOVI-2 program, which includes physical activity at weekends as well. This paper reports the rationale and methods of a trial to assess the effectiveness of MOVI-2 in preventing overweight and reducing cardiovascular risk in 1200 4th- and 5th-grade primary schoolchildren in Cuenca, Spain. Ten schools were randomly assigned to MOVI-2 and 10 schools to the control group. MOVI-2 consisted of recreational physical activity in after-school time, including two 90-min sessions on weekdays and one 150-min session on Saturdays, during each week of one academic year. The control group was expected to follow their usual patterns of physical activity. The primary end points, which were assessed at the start and the end of the MOVI-2 program, were weight and height, waist circumference, skinfold thickness, body fat percentage, blood pressure, lipid profile, and insulin resistance. Secondary end points were physical activity, fitness, health-related quality of life, sleep quality, academic performance, enjoyment with physical activity, and physical self-concept. This study will assess whether MOVI-2 overcomes some potential limitations of physical activity interventions in children (Clinicaltrials.gov number NCT01277224). Copyright © 2011 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.
Tawalbeh, Loai I
Simulation is an effective teaching strategy. However, no study in Jordan has examined the effect of simulation on the confidence of university nursing students in applying heart and lung physical examination skills. The current study aimed to test the effect of simulation on the confidence of university nursing students in applying heart and lung physical examination skills. A randomized controlled trial design was applied. The researcher introduced the simulation scenario regarding cardiopulmonary examination skills. This scenario included a 1-hour PowerPoint presentation and video for the experimental group (n= 35) and a PowerPoint presentation and a video showing a traditional demonstration in the laboratory for the control group (n = 34). Confidence in applying cardiopulmonary physical examination skills was measured for both groups at baseline and at 1 day and 3 months posttest. A paired t test showed that confidence was significantly higher in the posttest than in the pretest for both groups. An independent t test showed a statistically significant difference (t(67) = -42.95, p confidence in applying physical examination skills. Both simulation and traditional training in the laboratory significantly improved the confidence of participants in applying cardiopulmonary assessment skills. However, the simulation training had a more significant effect than usual training in enhancing the confidence of nursing students in applying physical examination skills.
Ventura, Sandra Rua; Ramos, Isabel; Rodrigues, Pedro Pereira
Background Mammography is considered the best imaging technique for breast cancer screening, and the radiographer plays an important role in its performance. Therefore, continuing education is critical to improving the performance of these professionals and thus providing better health care services. Objective Our goal was to develop an e-learning course on breast imaging for radiographers, assessing its efficacy, effectiveness, and user satisfaction. Methods A stratified randomized controlled trial was performed with radiographers and radiology students who already had mammography training, using pre- and post-knowledge tests, and satisfaction questionnaires. The primary outcome was the improvement in test results (percentage of correct answers), using intention-to-treat and per-protocol analysis. Results A total of 54 participants were assigned to the intervention (20 students plus 34 radiographers) with 53 controls (19+34). The intervention was completed by 40 participants (11+29), with 4 (2+2) discontinued interventions, and 10 (7+3) lost to follow-up. Differences in the primary outcome were found between intervention and control: 21 versus 4 percentage points (pp), Pe-learning course is effective, especially for radiographers, which highlights the need for continuing education. PMID:25560547
Wang, Shuhua; Yang, Hongling; Zhang, Jie; Zhang, Bin; Liu, Tao; Gan, Lu; Zheng, Jiangang
Cerebral infarction frequently leads to mild cognitive impairment (MCI). Prompt management of MCI can prevent vascular dementia and improve patient outcome. This single center randomized controlled trial aims to investigate the efficacy and safety of acupuncture and nimodipine to treat post-cerebral infarction MCI. A total of 126 Chinese patients with post-cerebral infarction MCI recruited from the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine between April 2013 and June 2014 were randomized at 1:1: 1 ratio into nimodipine alone (30 mg/time and 3 times daily), acupuncture alone (30 min/time, 6 times/week), and nimodipine + acupuncture groups. The treatments were 3 months. Cognitive function was evaluated using Montreal Cognitive Assessment (MoCA) scale at enrollment interview, at the end of 3-month therapy, and at the post-treatment 3-month follow-up. The per-protocol set included 39, 40, and 40 patients from nimodipine alone, acupuncture alone, and the combination group, respectively, was analyzed. Intra-group comparison revealed that MoCA score at the follow-up improved significantly by 15.8 ± 10.9, 20.9 ± 13.8 %, and 30.2 ± 19.7 % compared with the baseline MoCA for nimodipine alone, acupuncture alone, and the combination group, respectively. Inter-group comparison demonstrated that the combination therapy improved MoCA score (5.5 ± 2.2) at significantly higher extent than nimodipine alone (3.1 ± 1.8) and acupuncture alone (4.3 ± 2.3) at the follow-up (All P nimodipine alone group (56.4 %) showed ≥12 % MoCA score improvement compared with the baseline MoCA (All P < 0.05). No adverse event was reported during the study. Acupuncture may be used as an additional therapy to conventional pharmacological treatment to further improve the clinical outcomes of patients with post-cerebral infarction MCI. The study was registered at the Chinese Clinical Trial Registry ( http
Full Text Available Cliff Richardson,1 Lisa Brunton,1 Nicola Olleveant,1 David B Henson,1 Mark Pilling,1 Jane Mottershead,2 Cecilia H Fenerty,2 Anne Fiona Spencer,2 Heather Waterman1 1School of Nursing, Midwifery and Social Work, University of Manchester, 2Royal Manchester Eye Hospital, Central Manchester Foundation Trust, Manchester, United Kingdom Background: Adherence with therapy could influence the progression of glaucoma and ultimately affect the onset of visual impairment in some individuals. This feasibility study evaluated the measures to be used for a future randomized controlled trial assessing the effects of group-based education on adherence with eye drops. Methods: People diagnosed with glaucoma within the previous 12 months attending a regional ophthalmology clinic in the North West of England were recruited. A two-session education program delivered one week apart had been devised as part of a previous project. A combined adult learning and health needs approach to education was taken. Outcomes measured were knowledge of glaucoma, self-report of adherence, illness perception, beliefs about medicines, patient enablement, and general health (Short Form-12. Adherence was also measured objectively using a Medical Events Monitoring System device. Results: Twenty-six participants consented to undertake the educational program and 19 produced analyzable data. Knowledge of glaucoma, illness perception, beliefs about medicine, and patient enablement all showed statistically significant improvements after education. Mean adherence with eye drops was maintained above 85% before and for 3 months after attendance at the educational program. Self-report exaggerated adherence by at least 10% when compared with the objective Medical Events Monitoring System data, and in fact the kappa agreement was zero. Conclusion: All questionnaires other than the Short Form-12 were considered to be valuable measures and use of a Medical Events Monitoring System device was
Loomba, Rohit; Sirlin, Claude B; Ang, Brandon; Bettencourt, Ricki; Jain, Rashmi; Salotti, Joanie; Soaft, Linda; Hooker, Jonathan; Kono, Yuko; Bhatt, Archana; Hernandez, Laura; Nguyen, Phirum; Noureddin, Mazen; Haufe, William; Hooker, Catherine; Yin, Meng; Ehman, Richard; Lin, Grace Y; Valasek, Mark A; Brenner, David A; Richards, Lisa
Ezetimibe inhibits intestinal cholesterol absorption and lowers low-density lipoprotein cholesterol. Uncontrolled studies have suggested that it reduces liver fat as estimated by ultrasound in nonalcoholic steatohepatitis (NASH). Therefore, we aimed to examine the efficacy of ezetimibe versus placebo in reducing liver fat by the magnetic resonance imaging-derived proton density-fat fraction (MRI-PDFF) and liver histology in patients with biopsy-proven NASH. In this randomized, double-blind, placebo-controlled trial, 50 patients with biopsy-proven NASH were randomized to either ezetimibe 10 mg orally daily or placebo for 24 weeks. The primary outcome was a change in liver fat as measured by MRI-PDFF in colocalized regions of interest within each of the nine liver segments. Novel assessment by two-dimensional and three-dimensional magnetic resonance elastography was also performed. Ezetimibe was not significantly better than placebo at reducing liver fat as measured by MRI-PDFF (mean difference between the ezetimibe and placebo arms -1.3%, P = 0.4). Compared to baseline, however, end-of-treatment MRI-PDFF was significantly lower in the ezetimibe arm (15%-11.6%, P < 0.016) but not in the placebo arm (18.5%-16.4%, P = 0.15). There were no significant differences in histologic response rates, serum alanine aminotransferase and aspartate aminotransferase levels, or longitudinal changes in two-dimensional and three-dimensional magnetic resonance elastography-derived liver stiffness between the ezetimibe and placebo arms. Compared to histologic nonresponders (25/35), histologic responders (10/35) had a significantly greater reduction in MRI-PDFF (-4.35 ± 4.9% versus -0.30 ± 4.1%, P < 0.019). Ezetimibe did not significantly reduce liver fat in NASH. This trial demonstrates the application of colocalization of MRI-PDFF-derived fat maps and magnetic resonance elastography-derived stiffness maps of the liver before and after treatment to noninvasively assess treatment
Full Text Available Introduction: The burden of cardiovascular disease is increasing in India. It is a chronic condition, and poor management can increase the risk and frequency of acute episodes resulting in poor quality of life (QOL, frequent hospital admissions, and mortality. Disease management programs can improve medication adherence and patient's QOL. Objective: The aim of this study is to assess the effectiveness of nurse-led home-based heart failure management program (HOME-N. Materials and Methods: This randomized controlled trial was conducted among fifty outpatient heart failure (HF patients visiting a tertiary care hospital. The control group received usual routine care, whereas the experimental group received HOME-N, which included formal health teaching, a HF checklist (Hriday card, telemonitoring of vital parameters (blood pressure, heart rate, and weight weekly through a mobile application named as “Dhadkan” and telephonic follow-up for 3 months. Kansas City Cardiomyopathy Questionnaire (KCCQ and adherence to refills and medications scale were used to assess QOL and drug adherence, respectively, in the study patients. The outcome measures were the QOL, drug compliance, hospitalization, and mortality rate. Results: At baseline, the demographic and morbidity profile, and QOL and drug compliance scores of both groups were comparable. After intervention, the QOL domain score of KCCQ as well as drug compliance improved significantly both within the experimental group (P = 0.001, P = 0.001 and as compared to control group (P = 0.001, P = 0.004, respectively. Conclusion: The HOME-N was significantly effective in improving QOL and drug compliance in HF patients.
Christley Robert M
Full Text Available Abstract Background Gastro-intestinal parasitism has been identified as a significant cause of disease in working equids in many countries. This randomized triple-blind trial was designed to assess the impact of an anthelmintic treatment programme (using oral ivermectin and fenbendazole comparing treated and placebo control populations of working donkeys, mules and horses in field conditions in Morocco. In particular, we assessed animal body weight and condition score, together with a questionnaire-based owner evaluation of number of subjective animal health parameters. Faecal worm egg count was also measured. Results 239 animals completed the full study, 130 in the treatment group and 109 in the control group. Although the average animal weight increased during the study, this change was not significantly different between the two groups. Animals in the treatment group had a significantly lower strongyle worm egg count and increased in body condition score compared to animals in the control group at each examination during the study period. Owners of animals in the treatment group reported improvement in health and work ability and a beneficial effect on pruritus during the early period of the study. These differences in owner perception between treatment groups had disappeared in the latter stages of the study. Conclusion This study demonstrated that a routine anthelmintic treatment programme of three treatments annually can have a significant effect on faecal worm egg count. There may be beneficial consequences for the animal health and productivity. Further research on other populations of working equids in different environments would facilitate the objective planning of effective parasite control strategies for specific situations and provide better understanding of the likely clinical benefits of such programmes.
Al Otaiba, Stephanie; Connor, Carol M; Folsom, Jessica Sidler; Greulich, Luana; Meadows, Jane; Li, Zhi
The purpose of this cluster-randomized control field trial was to was to examine the extent to which kindergarten teachers could learn a promising instructional strategy, wherein kindergarten reading instruction was differentiated based upon students' ongoing assessments of language and literacy skills and documented child characteristic by instruction (CXI) interactions; and to test the efficacy of this differentiated reading instruction on the reading outcomes of students from culturally diverse backgrounds. The study involved 14 schools and included 23 treatment ( n = 305 students) and 21 contrast teacher ( n = 251 students). Teachers in the contrast condition received only a baseline professional development that included a researcher-delivered summer day-long workshop on individualized instruction. Data sources included parent surveys, individually administered child assessments of language, cognitive, and reading skills and videotapes of classroom instruction. Using Hierarchical Multivariate Linear Modeling (HMLM), we found students in treatment classrooms outperformed students in the contrast classrooms on a latent measure of reading skills, comprised of letter-word reading, decoding, alphabetic knowledge, and phonological awareness (ES = .52). Teachers in both conditions provided small group instruction, but teachers in the treatment condition provided significantly more individualized instruction. Our findings extend research on the efficacy of teachers using Individualized Student Instruction to individualize instruction based upon students' language and literacy skills in first through third grade. Findings are discussed regarding the value of professional development related to differentiating core reading instruction and the challenges of using Response to Intervention approaches to address students' needs in the areas of reading in general education contexts.
Al Otaiba, Stephanie; Connor, Carol M; Folsom, Jessica Sidler; Greulich, Luana; Meadows, Jane; Li, Zhi
The purpose of this cluster-randomized control field trial was to was to examine the extent to which kindergarten teachers could learn a promising instructional strategy, wherein kindergarten reading instruction was differentiated based upon students’ ongoing assessments of language and literacy skills and documented child characteristic by instruction (CXI) interactions; and to test the efficacy of this differentiated reading instruction on the reading outcomes of students from culturally diverse backgrounds. The study involved 14 schools and included 23 treatment (n = 305 students) and 21 contrast teacher (n = 251 students). Teachers in the contrast condition received only a baseline professional development that included a researcher-delivered summer day-long workshop on individualized instruction. Data sources included parent surveys, individually administered child assessments of language, cognitive, and reading skills and videotapes of classroom instruction. Using Hierarchical Multivariate Linear Modeling (HMLM), we found students in treatment classrooms outperformed students in the contrast classrooms on a latent measure of reading skills, comprised of letter-word reading, decoding, alphabetic knowledge, and phonological awareness (ES = .52). Teachers in both conditions provided small group instruction, but teachers in the treatment condition provided significantly more individualized instruction. Our findings extend research on the efficacy of teachers using Individualized Student Instruction to individualize instruction based upon students’ language and literacy skills in first through third grade. Findings are discussed regarding the value of professional development related to differentiating core reading instruction and the challenges of using Response to Intervention approaches to address students’ needs in the areas of reading in general education contexts. PMID:21818158
Wang, Chenchen; Iversen, Maura D; McAlindon, Timothy; Harvey, William F; Wong, John B; Fielding, Roger A; Driban, Jeffrey B; Price, Lori Lyn; Rones, Ramel; Gamache, Tressa; Schmid, Christopher H
Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults ≥ 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind
Palter, Vanessa N; Orzech, Neil; Reznick, Richard K; Grantcharov, Teodor P
: To develop and validate an ex vivo comprehensive curriculum for a basic laparoscopic procedure. : Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Moreover, neither the effect of ex vivo training on learning curves in the operating room (OR), nor the effect on nontechnical proficiency has been investigated. : This randomized single-blinded prospective trial allocated 20 surgical trainees to a structured training and assessment curriculum (STAC) group or conventional residency training. The STAC consisted of case-based learning, proficiency-based virtual reality training, laparoscopic box training, and OR participation. After completion of the intervention, all participants performed 5 sequential laparoscopic cholecystectomies in the OR. The primary outcome measure was the difference in technical performance between the 2 groups during the first laparoscopic cholecystectomy. Secondary outcome measures included differences with respect to learning curves in the OR, technical proficiency of each sequential laparoscopic cholecystectomy, and nontechnical skills. : Residents in the STAC group outperformed residents in the conventional group in the first (P = 0.004), second (P = 0.036), third (P = 0.021), and fourth (P = 0.023) laparoscopic cholecystectomies. The conventional group demonstrated a significant learning curve in the OR (P = 0.015) in contrast to the STAC group (P = 0.032). Residents in the STAC group also had significantly higher nontechnical skills (P = 0.027). : Participating in the STAC shifted the learning curve for a basic laparoscopic procedure from the operating room into the simulation laboratory. STAC-trained residents had superior technical proficiency in the OR and nontechnical skills compared with conventionally trained residents. (The study registration ID is NCT01560494.).
Sinkey, Rachel G; Eschenbacher, Michaela A; Walsh, Peggy M; Doerger, Rita G; Lambers, Donna S; Sibai, Baha M; Habli, Mounira A
Our objective was to compare the pain/stress levels of newborns among the 2 most common circumcision techniques after resident-wide education. The study period of this randomized control trial was October 2012 through March 2014. Following informed consent, full-term males from uncomplicated singleton pregnancies were randomized to Gomco (n=137) or Mogen (n=137) devices. Resident-wide education for an obstetrics and gynecology residency program at a single institution was performed to ensure standardized training. All infants received a subcutaneous ring block before the procedure and oral sucrose intraoperatively. The primary outcome was neonatal pain assessed physiologically by salivary cortisol levels (enzyme-linked immunosorbent assay) and clinically by a validated neonatal pain score (crying, requires increased oxygen administration, increased vital signs, expression, sleeplessness [CRIES]). Secondary outcomes were immediate complications, duration of procedure, and short-term outcomes as reported by mothers and pediatricians. A sample size of 274 (accounting for 20% loss of follow-up) was determined sufficient to detect a mean difference of 1.22 μg/dL in cortisol levels (Gomco, SD±3.34; Mogen, SD±0.81) with 80% power, P=.05 level of significance. A total of 251 infants completed the protocol. There were no significant differences in maternal or neonatal demographics including preoperative heart rate and mean arterial pressure. In the Mogen circumcision, the percentage change of cortisol was significantly lower than Gomco (279.1±498.15 vs 167.75±272.22; P=.049). There were no differences in postoperative CRIES scores. Postoperative heart rate was higher in infants undergoing Gomco circumcision than Mogen circumcision (138.7±16.5 vs 133.4±17.5; P=.015) as was mean arterial blood pressure (63.3±9.2 vs 60.4±8.6; P=.012). Mogen circumcisions were shorter (7.00±2.97 vs 3.65±1.84 minutes; Psignificant differences in bleeding complications. A total of 168
Bendtsen, Preben; McCambridge, Jim; Bendtsen, Marcus; Karlsson, Nadine; Nilsen, Per
University students in Sweden routinely receive proactive mail-based alcohol Internet interventions sent from student health services. This intervention provides personalized normative feedback on alcohol consumption with suggestions on how to decrease drinking. Earlier feasibility trials by our group and others have examined effectiveness in simple parallel-groups designs. To evaluate the effectiveness of electronic screening and brief intervention, using a randomized controlled trial design that takes account of baseline assessment reactivity (and other possible effects of the research process) due to the similarity between the intervention and assessment content. The design of the study allowed for exploration of the magnitude of the assessment effects per se. This trial used a dismantling design and randomly assigned 5227 students to 3 groups: (1) routine practice assessment and feedback, (2) assessment-only without feedback, and (3) neither assessment nor feedback. At baseline all participants were blinded to study participation, with no contact being made with group 3. We approached students 2 months later to participate in a cross-sectional alcohol survey. All interventions were fully automated and did not have any human involvement. All data used in the analysis were based on self-assessment using questionnaires. The participants were unaware that they were participating in a trial and thus were also blinded to which group they were randomly assigned. Overall, 44.69% (n = 2336) of those targeted for study completed follow-up. Attrition was similar in groups 1 (697/1742, 40.01%) and 2 (737/1742, 42.31% retained) and lower in group 3 (902/1743, 51.75% retained). Intention-to-treat analyses among all participants regardless of their baseline drinking status revealed no differences between groups in all alcohol parameters at the 2-month follow-up. Per-protocol analyses of groups 1 and 2 among those who accepted the email intervention (36.2% of the students who
Full Text Available Abstract Background Physician prescribing is the most frequent medical intervention with a highest impact on healthcare costs and outcomes. Therefore improving and promoting rational drug use is a great interest. We aimed to assess the effectiveness and cost-effectiveness of two forms of conducting prescribing audit and feedback interventions and a printed educational material intervention in improving physician prescribing. Method/design A four-arm randomized trial with economic evaluation will be conducted in Tehran. Three interventions (routine feedback, revised feedback, and printed educational material and a no intervention control arm will be compared. Physicians working in outpatient practices are randomly allocated to one of the four arms using stratified randomized sampling. The interventions are developed based on a review of literature, physician interviews, current experiences in Iran and with theoretical insights from the Theory of Planned Behavior. Effects of the interventions on improving antibiotics and corticosteroids prescribing will be assessed in regression analyses. Cost data will be assessed from a health care provider’s perspective and incremental cost-effectiveness ratios will be calculated. Discussion This study will determine the effectiveness and cost-effectiveness of three interventions and allow us to determine the most effective interventions in improving prescribing pattern. If the interventions are cost-effective, they will likely be applied nationwide. Trial registration Iranian Registry of Clinical Trials Registration Number: IRCT201106086740N1Pharmaceutical Sciences Research Center of TUMS Ethics Committee Registration Number: 90-02-27-07
Margaret P Rayman
Full Text Available Evidence that selenium affects the risk of type-2 diabetes is conflicting, with observational studies and a few randomized trials showing both lower and higher risk linked to the level of selenium intake and status. We investigated the effect of selenium supplementation on the risk of type-2 diabetes in a population of relatively low selenium status as part of the UK PRECISE (PREvention of Cancer by Intervention with SElenium pilot study. Plasma adiponectin concentration, a recognised independent predictor of type-2 diabetes risk and known to be correlated with circulating selenoprotein P, was the biomarker chosen.In a randomized, double-blind, placebo-controlled trial, five hundred and one elderly volunteers were randomly assigned to a six-month intervention with 100, 200 or 300 µg selenium/d as high-selenium or placebo yeast. Adiponectin concentration was measured by ELISA at baseline and after six months of treatment in 473 participants with one or both plasma samples available.Mean (SD plasma selenium concentration was 88.5 ng/g (19.1 at baseline and increased significantly in the selenium-treatment groups. In baseline cross-sectional analyses, the fully adjusted geometric mean of plasma adiponectin was 14% lower (95% CI, 0-27% in the highest than in the lowest quartile of plasma selenium (P for linear trend = 0.04. In analyses across randomized groups, however, selenium supplementation had no effect on adiponectin levels after six months of treatment (P = 0.96.These findings are reassuring as they did not show a diabetogenic effect of a six-month supplementation with selenium in this sample of elderly individuals of relatively low selenium status.
Wu, Chia-Yi; Lin, Yi-Yin; Yeh, Mei Chang; Huang, Lian-Hua; Chen, Shaw-Ji; Liao, Shih-Cheng; Lee, Ming-Been
The evidence of suicide prevention training for nurses is scarce. Strategies to enhance general nurses' ability in suicide risk assessment are critical to develop effective training programs in general medical settings. This study was aimed to examine the effectiveness of an interactive discussion group in a suicide prevention training program for general nurses. In this randomized study with two groups of pre-post study design, the sample was recruited from the Medical, Surgical, and Emergency/Intensive Care Sectors of a 2000-bed general hospital via stratified randomization. Among the 111 nurses, 57 participants randomly assigned to the control group received a two-hour baseline suicide gatekeeper lecture, and 54 participants assigning to the experimental group received an additional five-hour group discussion about suicide risk assessment skills. Using a case vignette, the nurses discussed and assessed suicide risk factors specified in a 10-item Chinese SAD PERSONS Scale during a group discussion intervention. The findings revealed that the nurses achieved significant and consistent improvements of risk identification and assessment after the intervention without influencing their mental health status for assessing suicide risks. The result suggested an effective approach of interactive group discussion for facilitating critical thinking and learning suicide risk assessment skills among general nurses. Copyright © 2014 Elsevier Ltd. All rights reserved.
McShane, Lisa M.; Korn, Edward L.
Clinical biomarker tests that aid in making treatment decisions will play an important role in achieving personalized medicine for cancer patients. Definitive evaluation of the clinical utility of these biomarkers requires conducting large randomized clinical trials (RCTs). Efficient RCT design is therefore crucial for timely introduction of these medical advances into clinical practice, and a variety of designs have been proposed for this purpose. To guide design and interpretation of RCTs evaluating biomarkers, we present an in-depth comparison of advantages and disadvantages of the commonly used designs. Key aspects of the discussion include efficiency comparisons and special interim monitoring issues that arise because of the complexity of these RCTs. Important ongoing and completed trials are used as examples. We conclude that, in most settings, randomized biomarker-stratified designs (ie, designs that use the biomarker to guide analysis but not treatment assignment) should be used to obtain a rigorous assessment of biomarker clinical utility. PMID:20075367
Weitlauf, Julie C; Ruzek, Josef I; Westrup, Darrah A; Lee, Tina; Keller, Jennifer
A growing body of empirical literature has systematically documented the reactions to research participation among participants in traumafocused research. To date, the available data has generally presented an optimistic picture regarding participants' ability to tolerate and even find benefit from their participation. However, this literature has been largely limited to cross-sectional designs. No extant literature has yet examined the perceptions of participants with psychiatric illness who are participating in randomized clinical trials (RCTs) designed to evaluate the efficacy or effectiveness of novel trauma treatments. The authors posit that negative experiences of, or poor reactions to, the research experience in the context of a trauma-focused RCT may elevate the risk of participation. Indeed, negative reactions may threaten to undermine the potential therapeutic gains of participants and promoting early drop out from the trial. Empirically assessing reactions to research participation at the pilot-study phase of a clinical trial can both provide investigators and IRB members alike with empirical evidence of some likely risks of participation. In turn, this information can be used to help shape the design and recruitment methodology of the full-scale trial. Using data from the pilot study of the Women's Self-Defense Project as a case illustration, we provide readers with concrete suggestions for empirically assessing participants' perceptions of risk involved in their participation in behaviorally oriented clinical trials.
Carlsson, Lars; Englund, Lars; Hallqvist, Johan; Wallman, Thorne
To study the effects on sick leave from an early multidisciplinary assessment at a primary health care centre. Randomized controlled trial. Patients who saw GPs at a primary health care centre in mid-Sweden and asked for a sickness certificate for psychiatric or musculoskeletal diagnoses were invited to participate. Patients included were sick-listed for less than four weeks; 33 patients were randomized either to an assessment within a week by a physiotherapist, a psychotherapist, and an occupational therapist or to "standard care". The therapists used methods and tools they normally use in their clinical work. Proportion of patients still sick-listed three months after randomization, total and net days on sick leave, and proportion who were on part-time sick leave. Results. At follow-up after three months, in contrast to the pre-trial hypothesis, there was a trend toward a higher proportion of patients still sick-listed in the intervention group (7/18) as compared with the control group (3/15). The intervention group also had significantly longer sick-listing periods (mean 58 days) than the control group (mean 36 days) (p = 0.038). The proportion of patients who were part time sick-listed was significantly higher in the intervention group (10/18) than in the control group (2/15) (p = 0.027). In this study an early multidisciplinary assessment was associated with longer periods on sick leave and more individuals on part-time sick leave.
Hróbjartsson, A; Forfang, E; Haahr, M T
Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful.......Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....
Burns, T; Millar, E; Garland, C; Kendrick, T; Chisholm, B; Ross, F
BACKGROUND: A third of patients with schizophrenia are out of contact with secondary services. Many of these patients receive maintenance medication as depot antipsychotics from practice nurses, most of whom have negligible training in mental health. AIM: To examine the impact of a structured assessment on the process of care and clinical status of schizophrenia patients by practice nurses who received a one-day training course. METHOD: All identified patients were randomly allocated to struc...
Mathur, N B; Saini, Ashish; Mishra, T K
To compare the effect of 400 IU and 1000 IU vitamin D for 6 weeks in very low birth weight preterm neonates. Randomized, double-blinded controlled trial in a teaching hospital. Fifty very low birth weight preterm neonates. Vitamin D 400 IU/day (Group 1) or 1000 IU/day (Group 2). Change in serum calcium, phosphate, alkaline phosphatase (ALP), 25-hydroxy vitamin D (25-OHD), parathormone, incidence of skeletal hypomineralization and growth. After 6 weeks of supplementation, the mean serum calcium and 25-OHD levels were significantly higher (p supplementation in a dose of 1000 IU/day is more effective in maintaining serum calcium, phosphate, ALP, 25-OHD and parathormone levels with lower incidence of skeletal hypomineralization and better growth. © The Author . Published by Oxford University Press. All rights reserved. For Permissions, please email: email@example.com.
Ahn, Chul; Ahn, Daniel
A randomized clinical trial (RCT) is widely regarded as the most rigorous study design to determine the efficacy of intervention since spurious causality and bias associated with other experimental designs can be avoided. The purpose of this article is to provide clinicians and clinical researchers with the types of randomized clinical trials used in stroke studies and to discuss the advantages and limitations in each type of randomized stroke clinical trials.
Jolliet, Philippe; Ouanes-Besbes, Lamia; Abroug, Fekri; Ben Khelil, Jalila; Besbes, Mohamed; Garnero, Aude; Arnal, Jean-Michel; Daviaud, Fabrice; Chiche, Jean-Daniel; Lortat-Jacob, Benoît; Diehl, Jean-Luc; Lerolle, Nicolas; Mercat, Alain; Razazi, Keyvan; Brun-Buisson, Christian; Durand-Zaleski, Isabelle; Texereau, Joëlle; Brochard, Laurent
During noninvasive ventilation (NIV) for chronic obstructive pulmonary disease (COPD) exacerbations, helium/oxygen (heliox) reduces the work of breathing and hypercapnia more than air/O2, but its impact on clinical outcomes remains unknown. To determine whether continuous administration of heliox for 72 hours, during and in-between NIV sessions, was superior to air/O2 in reducing NIV failure (25-15%) in severe hypercapnic COPD exacerbations. This was a prospective, randomized, open-label trial in 16 intensive care units (ICUs) and 6 countries. Inclusion criteria were COPD exacerbations with PaCO2 ≥ 45 mm Hg, pH ≤ 7.35, and at least one of the following: respiratory rate ≥ 25/min, PaO2 ≤ 50 mm Hg, and oxygen saturation (arterial [SaO2] or measured by pulse oximetry [SpO2]) ≤ 90%. A 6-month follow-up was performed. The primary endpoint was NIV failure (intubation or death without intubation in the ICU). The secondary endpoints were physiological parameters, duration of ventilation, duration of ICU and hospital stay, 6-month recurrence, and rehospitalization rates. The trial was stopped prematurely (445 randomized patients) because of a low global failure rate (NIV failure: air/O2 14.5% [n = 32]; heliox 14.7% [n = 33]; P = 0.97, and time to NIV failure: heliox group 93 hours [n = 33], air/O2 group 52 hours [n = 32]; P = 0.12). Respiratory rate, pH, PaCO2, and encephalopathy score improved significantly faster with heliox. ICU stay was comparable between the groups. In patients intubated after NIV failed, patients on heliox had a shorter ventilation duration (7.4 ± 7.6 d vs. 13.6 ± 12.6 d; P = 0.02) and a shorter ICU stay (15.8 ± 10.9 d vs. 26.7 ± 21.0 d; P = 0.01). No difference was observed in ICU and 6-month mortality. Heliox improves respiratory acidosis, encephalopathy, and the respiratory rate more quickly than air/O2 but does not prevent NIV failure. Overall, the rate of NIV
The chief therapeutic goal in metastatic prostate cancer is prolongation of survival with good quality of life . Quality of life (health-related) is often used as an endpoint parameter in phase III trials in metastatic prostate cancer, but the value of using HRQOL in this context has not been assessed to date. In order to evaluate the role of HRQOL assessment in contemporary phase III trials in prostate cancer, we searched the PubMed database to identify publications presenting the results of these trials on systemic therapies for prostate cancer published between January 2000 and December 2015. The analysis was separately presented in ten leading journals. We searched for companion papers reporting on QOL separately. We identified 84 studies which included a total of 57,193 patients in ten leading journals and 27 studies (7270 patients) in other journals. HRQOL parameters were described or mentioned in the main publication in 25 publications and four companions in total. There was no obvious trend in quality of life reported over two 8-year periods . The explicit statistical comparisons were reported in 22/25 cases (88 %), with significant difference in only 10/25 (40 %) studies and in eight cases (80 %) was conducive to the examined arm. There was no significant association between improvements in HRQOL and improvements in overall survival (OS) or any other primary endpoint in the analyzed studies. Only one study was found which presented the difference in quality of life with no difference in the primary endpoint. HRQOL is an indicator of benefit during treatment of patients with metastatic prostate cancer, but it is unlikely that HRQOL results can help clinicians choose between treatments given that they are not correlated with changes in OS or at other primary endpoints.
Lisandra V Martins
Full Text Available BACKGROUND: Shoulder pain in nursing professionals may lead to limitations in occupational and daily activities and consequently interfere with quality of life. OBJECTIVE: To compare the effects of two physical therapy programs which differed in the proprioceptive exercises used on the nursing professionals with rotator cuff disorder, according to quality of life, work satisfaction indicators, and pain intensity. METHOD: This study was an experimental, randomized, prospective, comparative trial with quantitative data analysis. The data sampling was carried out between the months of June 2010 and July 2011 by means of a questionnaire containing socio-demographic and professional information, the Western Ontario Rotator Cuff Index (WORC, the Occupational Stress Indicator (OSI, and the Visual Numeric Scale (VNS. Based on randomization, subjects were divided into two groups. Group 1 (control was submitted to stretching and strengthening exercises and cryotherapy. Group 2 (experimental was treated with the same protocol as the control group, with the addition of proprioception exercises. The data was analyzed by means of the Statistical Package for the Social Science version 16.0 for Windows. RESULTS: After physical therapy intervention, significant reduction in pain levels occurred in both groups, with a significant improvement in quality of life for Group 2. No changes were observed in the work satisfaction indicators after the two types of physical therapy interventions. CONCLUSIONS: The proprioceptive exercises were important in the treatment of musculoskeletal disorders, however the results did not allow us to determine which treatment was the most effective as there was no significant difference between groups.
Sigmarsdóttir, Margrét; Degarmo, David S; Forgatch, Marion S; Guðmundsdóttir, Edda Vikar
Findings are presented from an Icelandic randomized control trial (RCT) evaluating parent management training - Oregon model (PMTO™), a parent training intervention designed to improve parenting practices and reduce child behavior problems. In a prior report from this effectiveness study that focused on child outcomes, children in the PMTO condition showed greater reductions in reported child adjustment problems relative to the comparison group. The present report focuses on observed parenting practices as the targeted outcome, with risk by treatment moderators also tested. It was hypothesized that mothers assigned to the PMTO condition would show greater gains in pre-post parenting practices relative to controls. The sample was recruited from five municipalities throughout Iceland and included 102 participating families of children with behavior problems. Cases were referred by community professionals and randomly assigned to either PMTO (n = 51) or community services usually offered (n = 51). Child age ranged from 5 to 12 years; 73% were boys. Contrary to expectations, findings showed no main effects for changes in maternal parenting. However, evaluation of risk by treatment moderators showed greater gains in parenting practices for mothers who increased in depressed mood within the PMTO group relative to their counterparts in the comparison group. This finding suggests that PMTO prevented the expected damaging effects of depression on maternal parenting. Failure to find hypothesized main effects may indicate that there were some unobserved factors regarding the measurement and a need to further adapt the global observational procedures to Icelandic culture. © 2013 The Scandinavian Psychological Associations.
Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R
Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.
Bartholomew, John B; Jowers, Esbelle M; Errisuriz, Vanessa L; Vaughn, Sharon; Roberts, Gregory
Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity. The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning. This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions. Copyright © 2017 Elsevier Inc. All rights reserved.
Carter Alice S
Full Text Available Abstract Background The prevalence of social-emotional and behavioral problems is estimated to be 8 to 9% among preschool children. Effective early detection tools are needed to promote the provision of adequate care at an early stage. The Brief Infant-Toddler Social and Emotional Assessment (BITSEA was developed for this purpose. This study evaluates the effectiveness of the BITSEA to enhance social-emotional and behavioral health of preschool children. Methods and Design A cluster randomized controlled trial is set up in youth health care centers in the larger Rotterdam area in the Netherlands, to evaluate the BITSEA. The 31 youth health care centers are randomly allocated to either the control group or the intervention group. The intervention group uses the scores on the BITSEA and cut-off points to evaluate a child's social-emotional and behavioral health and to decide whether or not the child should be referred. The control group provides care as usual, which involves administering a questionnaire that structures the conversation between child health professionals and parents. At a one year follow-up measurement the social-emotional and behavioral health of all children included in the study population will be evaluated. Discussion It is hypothesized that better results will be found, in terms of social-emotional and behavioral health in the intervention group, compared to the control group, due to more adequate early detection, referral and more appropriate and timely care. Trial registration Current Controlled Trials NTR2035
Milligan Paul J
Full Text Available Abstract Background Mosquito-proofing homes was one of the principal methods of environmental management in the early 1900s. House screening provides protection against malaria by reducing exposure to malaria parasites and has the added benefit of protecting everyone sleeping in the house, avoiding issues of inequity within the household. The aim of this study is to determine whether house screening protects people against malaria in Africa. It is hoped that this study will mark the beginning of a series of trials assessing a range of environmental interventions for malaria control in Africa. Design A 3-armed randomised-controlled trial will be conducted in and around Farafenni town in The Gambia, West Africa, to assess whether screening windows, doors and closing eaves or installing netting ceilings in local houses can substantially reduce malaria transmission and anaemia compared to homes with no screening. Eligible houses will be sorted and stratified by location and the number of children in each house, then randomly allocated to the interventions in blocks of 5 houses (2 with full screening, 2 with screened ceilings and 1 control house without screening. Risk of malaria transmission will be assessed in each house by routine collections of mosquitoes using light traps and an anaemia prevalence study in children at the end of the main transmission period. Discussion Practical issues concerning intervention implementation, as well as the potential benefits and risks of the study, are discussed. Trial Registration ISRCTN51184253 – Screening-homes to prevent malaria
Carmen V Voogt
Full Text Available BACKGROUND: Alcohol consumption of college students has a fluctuating nature, which might impact the measurement of intervention effects. By using 25 follow-up time-points, this study tested whether intervention effects are robust or might vary over time. METHODS: Data were used from a two-arm parallel group randomized controlled trial applying ecological momentary assessment (EMA with 30 data time-points in total. Students between 18 and 24 years old who reported heavy drinking in the past six months and who were ready to change their alcohol consumption were randomly assigned to the experimental (n = 456: web-based brief alcohol intervention and control condition (n = 451: no intervention. Outcome measures were weekly alcohol consumption, frequency of binge drinking, and heavy drinking status. RESULTS: According to the intention-to-treat principle, regression analyses revealed that intervention effects on alcohol consumption varied when exploring multiple follow-up time-points. Intervention effects were found for a weekly alcohol consumption at 1, 2, 3, 4, and 7 weeks follow-up, b frequency of binge drinking at 1, 2, 7, and 12 weeks follow-up, and c heavy drinking status at 1, 2, 7, and 16 weeks follow-up. CONCLUSIONS: This research showed that the commonly used one and six month follow-up time-points are relatively arbitrary and not using EMA might bring forth erroneous conclusions on the effectiveness of interventions. Therefore, future trials in alcohol prevention research and beyond are encouraged to apply EMA when assessing outcome measures and intervention effectiveness. TRIAL REGISTRATION: Netherlands Trial Register NTR2665.
Rietbergen, C.; Moerbeek, M.
The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own
Troelsen, Anders; Greene, Meridith E; Ayers, David C; Bragdon, Charles R; Malchau, Henrik
Conventional radiostereometric analysis (RSA) for wear is not possible in patients with tantalum cups. We propose a novel method for wear analysis in tantalum cups. Wear was assessed by gold standard RSA and the novel method in total hip arthroplasty patients enrolled in a randomized controlled trial receiving either titanium or tantalum cups (n=46). The novel method estimated the center of the head using a model based on identification of two proximal markers on the stem and knowledge of the stem/head configuration. The novel method was able to demonstrate a pattern of wear that was similar to the gold standard in titanium cups. The novel method offered accurate assessment and is a viable solution for assessment of wear in studies with tantalum cups. Copyright © 2015 Elsevier Inc. All rights reserved.
McCusker, Jane; Haggerty, Jeannie; De Raad, Manon; Belzile, Eric; Bouharaoui, Fatima; Beaulieu, Christine; Yaffe, Mark; Ciampi, Antonio
To validate 2 new patient-reported measures of self-management support from health professionals for mood and emotional problems. The sample comprised primary care patients with chronic physical conditions and co-morbid depressive symptoms enrolled in a randomized trial of telephone coaching of a depression self-care intervention (n=120). At 6-month follow-up, patients completed 2 subscales with respect to support for self-management of their chronic physical condition(s): 1) Self-Management Information (SMInfo-Phys); and 2) Care Plan (CP-Phys) and equivalent subscales adapted to assess self-management support for mood and emotional problems: SMInfo-Mood and CP-Mood. Subscale scoring was assessed with Item Response Theory (IRT) analysis. Convergent validity of the mood subscales was assessed. The sensitivity of the mood and physical condition subscales to mental health interventions was assessed with generalized estimating equations (GEE). The mood subscales were associated with relevant measures of perceived unmet mental health needs. Both SMInfo-Mood and CP-Mood were sensitive to the coaching intervention; CP-Mood was also sensitive to receipt of depression treatment outside the trial. This study provides preliminary evidence for the validity of the 2 new subscales. The subscales may be used to assess perceived health professional support for self-management of mood and emotional problems. Copyright © 2017 Elsevier B.V. All rights reserved.
Gustafsson, Finn; Atar, Dan; Pitt, Bertram
Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...
Stingl, Julia Carolin; Kaumanns, Katharina Luise; Claus, Katrin; Lehmann, Marie-Louise; Kastenmüller, Kathrin; Bleckwenn, Markus; Hartmann, Gunther; Steffens, Michael; Wirtz, Dorothee; Leuchs, Ann-Kristin; Benda, Norbert; Meier, Florian; Schöffski, Oliver; Holdenrieder, Stefan; Coch, Christoph; Weckbecker, Klaus
Elderly patients are particularly vulnerable to adverse drug reactions, especially if they are affected by additional risk factors such as multimorbidity, polypharmacy, impaired renal function and intake of drugs with high risk potential. Apart from these clinical parameters, drug safety and efficacy can be influenced by pharmacogenetic factors. Evidence-based recommendations concerning drug-gene-combinations have been issued by international consortia and in drug labels. However, clinical benefit of providing information on individual patient factors in a comprehensive risk assessment aiming to reduce the occurrence and severity of adverse drug reactions is not evident. Purpose of this randomized controlled trial is to compare the effect of a concise individual risk information leaflet with standard information on risk factors for side effects. The trial was designed as a prospective, two-arm, randomized, controlled, multicenter, pragmatic study. 960 elderly, multimorbid outpatients in general medicine are included if they take at least one high risk and one other long-term drug (polymedication). As high risk "index drugs" oral anticoagulants and antiplatelets were chosen because of their specific, objectively assessable side effects. Following randomization, test group patients receive an individualized risk assessment leaflet evaluating their personal data concerning bleeding- and thromboembolic-risk-scores, potential drug-drug-interactions, age, renal function and pharmacogenetic factors. Control group patients obtain a standardized leaflet only containing general information on these criteria. Follow-up period is 9 months for each patient. Primary endpoint is the occurrence of a thromboembolic/bleeding event or death. Secondary endpoints are other adverse drug reactions, hospital admissions, specialist referrals and medication changes due to adverse drug reactions, the patients' adherence to medication regimen as well as health related quality of life
Full Text Available Physician prescribing is the most frequent medical intervention with a highest impact on healthcare costs and outcomes. Therefore improving and promoting rational drug use is a great interest. We aimed to assess the effectiveness and cost-effectiveness of two forms of conducting prescribing audit and feedback interventions and a printed educational material intervention in improving physician prescribing.Method/design: A four-arm randomized trial with economic evaluation will be conducted in Tehran. Three interventions (routine feedback, revised feedback, and printed educational material and a no intervention control arm will be compared. Physicians working in outpatient practices are randomly allocated to one of the four arms using stratified randomized sampling. The interventions are developed based on a review of literature, physician interviews, current experiences in Iran and with theoretical insights from the Theory of Planned Behavior. Effects of the interventions on improving antibiotics and corticosteroids prescribing will be assessed in regression analyses. Cost data will be assessed from a health care provider's perspective and incremental cost-effectiveness ratios will be calculated.DiscussionThis study will determine the effectiveness and cost-effectiveness of three interventions and allow us to determine the most effective interventions in improving prescribing pattern. If the interventions are cost-effective, they will likely be applied nationwide.
The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial
Background In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personality disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual. Methods/Design The trial is designed as a single-center, two-armed, parallel-group observer-blinded randomized clinical superiority trial. We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention, Capital Region of Denmark. Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence. The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy, where the duration treatment will vary in accordance with established methods up to 16 weeks. The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger
Tunuguntla, Renuka; Rodriguez, Osvaldo; Ruiz, Jorge G; Qadri, Syeda S; Mintzer, Michael J; Van Zuilen, Maria H; Roos, Bernard A
Although animations may intuitively seem more effective than static graphics for teaching, there is no clear-cut evidence for the superiority of simple computer-based animations in medical education. We investigated whether simple animations are better than static graphics as an aid to medical students in learning home safety assessment, an important part of geriatric curriculum. We used two versions of an interactive online module, one that depicted common home safety issues in static graphics and the other in animations. We randomized first-year medical students who agreed to participate into two groups. After the module, students completed a cognitive burden scale and a standardized competency assessment test in which they had to identify the salient home safety issues and give recommendations based on the hazards. We also captured time spent on task. We found no significant differences between the groups in the cognitive burden level, competency assessment scores, and time spent on task. The much cheaper-to-produce static graphics were equally effective as simple animations in this medical education scenario.
Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John
To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.
Radhika, C; Kumar, G Vinod; Mihirjan, K
This work was designed to assess the efficacy of Nasya in reducing the signs and symptoms of cervical spondylosis. The patients attending the O. P. D of Department of Kaya Chikitsa and Panchakarma, Government Ayurveda College Hospital, Thiruvananthapuram were enrolled and subjected to the treatment schedule. Total duration of treatment was 21days. The schedule for the first 14 days was similar in both the groups. It included Rooksha Sveda for 7days followed by Patra Pottali Sveda for 7days. During this period, 90 ml Gandharvahastadi Kashaya twice and Guggulu Tiktaka Kashaya once were given internally. After this, in the Nasya group Nasya was done for 7days with Dhanwantaram Tailam (21times Aavartita), MriduPaka in Madhyama Matra (8Bindu). Along with this Guggulu Tiktaka Kashaya was given thrice. In the control group, Guggulu Tiktaka kashaya alone was given thrice daily. Assessments were done with regard to pain, tenderness, radiation of pain, numbness, range of movements and hand grip strength. These were done before treatment, before nasya, after treatment and after 1month follow-up. The statistical hypothesis was tested using paired 't' test and 'Z' test for proportion. The trial proved that conventional management along with Nasya was more efficacious than conventional management alone in reducing the signs and symptoms of cervical spondylosis.
von Haaren, Birte; Ottenbacher, Joerg; Muenz, Julia; Neumann, Rainer; Boes, Klaus; Ebner-Priemer, Ulrich
The cross-stressor adaptation hypothesis suggests that regular exercise leads to adaptations in the stress response systems that induce decreased physiological responses to psychological stressors. Even though an exercise intervention to buffer the detrimental effects of psychological stressors on health might be of utmost importance, empirical evidence is mixed. This may be explained by the use of cross-sectional designs and non-personally relevant stressors. Using a randomized controlled trial, we hypothesized that a 20-week aerobic exercise training does reduce physiological stress responses to psychological real-life stressors in sedentary students. Sixty-one students were randomized to either a control group or an exercise training group. The academic examination period (end of the semester) served as a real-life stressor. We used ambulatory assessment methods to assess physiological stress reactivity of the autonomic nervous system (heart rate variability: LF/HF, RMSSD), physical activity and perceived stress during 2 days of everyday life and multilevel models for data analyses. Aerobic capacity (VO2max) was assessed pre- and post-intervention via cardiopulmonary exercise testing to analyze the effectiveness of the intervention. During real-life stressors, the exercise training group showed significantly reduced LF/HF (β = -0.15, t = -2.59, p = .01) and increased RMSSD (β = 0.15, t = 2.34, p = .02) compared to the control group. Using a randomized controlled trial and a real-life stressor, we could show that exercise appears to be a useful preventive strategy to buffer the effects of stress on the autonomic nervous system, which might result into detrimental health outcomes.
PHARMAID study protocol: Randomized controlled trial to assess the impact of integrated pharmaceutical care at a psychosocial intervention on caregiver's burden in Alzheimer's disease or related diseases.
Novais, T; Moutet, C; Delphin-Combe, F; Dauphinot, V; Colin, C; Krolak-Salmon, P; Mouchoux, C
Alzheimer's Disease and Related Diseases (ADRD) are associated with a caregiver burden that increases with the progression of the disease. Psychosocial interventions reported a moderate improvement on caregivers' burden. Patients with ADRD and their older caregivers are also exposed to a higher risk of developing drug-related problems. The main objective of the PHARMAID study is to measure the impact of personalized pharmaceutical collaborative care integrated to a multidisciplinary psychosocial program on the burden of caregivers. The PHARMAID study is a 18-month randomized controlled trial that started in September 2016. This paper describes the study protocol. PHARMAID plans to enroll 240 dyads, i.e. ADRD patients and caregivers, whose inclusion criteria are: outpatient with mild or major neurocognitive disorders due to ADRD, living at home, receiving support from a family caregiver. Three parallel groups will compare a control group with two experimental groups: psychosocial intervention and integrated pharmaceutical care at a psychosocial intervention. The main outcome is the caregiver's burden assessed by the Zarit Burden Index at 6, 12 and 18months. This is the first trial designed to assess the specific impact of the integration of pharmaceutical care in a multidisciplinary psychosocial program on the caregiver's burden. The results will inform policymakers on strategies to implement in the near future. [ClinicalTrials.gov: NCT02802371] Registered in June 2016. Copyright © 2016 Elsevier Inc. All rights reserved.
Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida
conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...
Vera, Angelina M; Russo, Michael; Mohsin, Adnan; Tsuda, Shawn
Laparoscopic skills training has evolved over recent years. However, conveying a mentor's directions using conventional methods, without realistic on-screen visual cues, can be difficult and confusing. To facilitate laparoscopic skill transference, an augmented reality telementoring (ART) platform was designed to overlay the instruments of a mentor onto the trainee's laparoscopic monitor. The aim of this study was to compare the effectiveness of this new teaching modality to traditional methods in novices performing an intracorporeal suturing task. Nineteen pre-medical and medical students were randomized into traditional mentoring (n = 9) and ART (n = 10) groups for a laparoscopic suturing and knot-tying task. Subjects received either traditional mentoring or ART for 1 h on the validated fundamentals of laparoscopic surgery intracorporeal suturing task. Tasks for suturing were recorded and scored for time and errors. Results were analyzed using means, standard deviation, power regression analysis, correlation coefficient, analysis of variance, and student's t test. Using Wright's cumulative average model (Y = aX (b)) the learning curve slope was significantly steeper, demonstrating faster skill acquisition, for the ART group (b = -0.567, r (2) = 0.92) than the control group (b = -0.453, r (2) = 0.74). At the end of 10 repetitions or 1 h of practice, the ART group was faster versus traditional (mean 167.4 vs. 242.4 s, p = 0.014). The ART group also had fewer fails (8) than the traditional group (13). The ART Platform may be a more effective training technique in teaching laparoscopic skills to novices compared to traditional methods. ART conferred a shorter learning curve, which was more pronounced in the first 4 trials. ART reduced the number of failed attempts and resulted in faster suture times by the end of the training session. ART may be a more effective training tool in laparoscopic surgical training for complex tasks than traditional methods.
Buerkle, Bernd; Pueth, Julia; Hefler, Lukas A; Tempfer-Bentz, Eva-Katrin; Tempfer, Clemens B
To compare the skills of performing a shoulder dystocia management algorithm after hands-on training compared with demonstration. We randomized medical students to a 30-minute hands-on (group 1) and a 30-minute demonstration (group 2) training session teaching a standardized shoulder dystocia management scheme on a pelvic training model. Participants were tested with a 22-item Objective Structured Assessment of Technical Skills scoring system after training and 72 hours thereafter. Objective Structured Assessment of Technical Skills scores were the primary outcome. Performance time, self-assessment, confidence, and global rating scale were the secondary outcomes. Statistics were performed using Mann-Whitney U test, χ test, and multiple linear regression analysis. Two hundred three participants were randomized. Objective Structured Assessment of Technical Skills scores were significantly higher in group 1 (n=103) compared with group 2 (n=100) (17.95±3.14 compared with 15.67±3.18, respectively; PTechnical Skills scores were still significantly higher in group 1 (n=67) compared with group 2 (n=60) (18.17±2.76 compared with 14.98±3.03, respectively; PTechnical Skills scores. Hands-on training helps to achieve a significant improvement of shoulder dystocia management on a pelvic training model. www.ClinicalTrials.gov, NCT01618565. I.
mammograms, where recall was defined as any assessment requiring additional imaging or evaluation on either breast (BI-RADS assessment of 0). 7/10/2008 7... images are being randomly selected, rescanned and re-read for density outcomes on an ongoing basis. All mammographic breast density measures were...timing of the exam (index or study mammogram). To evaluate quality assurance, we included four inter-batch repeats and four intra-batch repeats within
Voogt, Carmen V; Kuntsche, Emmanuel; Kleinjan, Marloes; Poelen, Evelien A P; Lemmers, Lex A C J; Engels, Rutger C M E
Alcohol consumption of college students has a fluctuating nature, which might impact the measurement of intervention effects. By using 25 follow-up time-points, this study tested whether intervention effects are robust or might vary over time. Data were used from a two-arm parallel group randomized controlled trial applying ecological momentary assessment (EMA) with 30 data time-points in total. Students between 18 and 24 years old who reported heavy drinking in the past six months and who were ready to change their alcohol consumption were randomly assigned to the experimental (n = 456: web-based brief alcohol intervention) and control condition (n = 451: no intervention). Outcome measures were weekly alcohol consumption, frequency of binge drinking, and heavy drinking status. According to the intention-to-treat principle, regression analyses revealed that intervention effects on alcohol consumption varied when exploring multiple follow-up time-points. Intervention effects were found for a) weekly alcohol consumption at 1, 2, 3, 4, and 7 weeks follow-up, b) frequency of binge drinking at 1, 2, 7, and 12 weeks follow-up, and c) heavy drinking status at 1, 2, 7, and 16 weeks follow-up. This research showed that the commonly used one and six month follow-up time-points are relatively arbitrary and not using EMA might bring forth erroneous conclusions on the effectiveness of interventions. Therefore, future trials in alcohol prevention research and beyond are encouraged to apply EMA when assessing outcome measures and intervention effectiveness. Netherlands Trial Register NTR2665.
Full Text Available Abstract Background Chronic lumbar radicular pain can be described as neuropathic pain along the distribution of a particular nerve root. The dorsal root ganglion has been implicated in its pathogenesis by giving rise to abnormal impulse generation as a result of irritation, direct compression and sensitization. Chronic lumbar radicular pain is commonly treated with medications, physiotherapy and epidural steroid injections. Epidural steroid injections are associated with several common and rarer side effects such as spinal cord infarction and death. It is essential and advantageous to look for alternate interventions which could be effective with fewer side effects. Pulse radio frequency is a relatively new technique and is less destructive then conventional radiofrequency. Safety and effectiveness of pulse radio frequency in neuropathic pain has been demonstrated in animal and humans studies. Although its effects on dorsal root ganglion have been studied in animals there is only one randomized control trial in literature demonstrating its effectiveness in cervical radicular pain and none in lumbar radicular pain. Our primary objective is to study the feasibility of a larger trial in terms of recruitment and methodology. Secondary objectives are to compare the treatment effects and side effects. Methods/designs This is a single-center, parallel, placebo-controlled, triple-blinded (patients, care-givers, and outcome assessors, randomized control trial. Participants will have a history of chronic lumbar radicular pain for at least 4 months in duration. Once randomized, all patients will have an intervention involving fluoroscopy guided needle placement to appropriate dorsal root ganglion. After test stimulation in both groups; the study group will have a pulse radio frequency treatment at 42°C for 120 s to the dorsal root ganglion, with the control group having only low intensity test stimulation for the same duration. Primary outcome is to
Okoniewska Barbara M
evaluation will assess the cost per life saved, cost per readmission avoided and cost per QALY gained with the TOC communication tool compared to traditional dictation summaries. Discussion This paper outlines the study protocol for a randomized controlled trial evaluating an electronic transfer-of-care communication tool, with sufficient statistical power to assess the impact of the tool on the significant outcomes of post-discharge death or readmission. The study findings will inform health systems around the world on the potential benefits of such tools, and the value for money associated with their widespread implementation. Trial registration ClinicalTrials.gov NCT01402609.
Jia, Yongliang; Leung, Siu-Wai
More than 230 randomized controlled trials (RCTs) of danshen dripping pill (DSP) and isosorbide dinitrate (ISDN) in treating angina pectoris after the first preferred reporting items for systematic reviews and meta-analyses-compliant comprehensive meta-analysis were published in 2010. Other meta-analyses had flaws in study selection, statistical meta-analysis, and evidence assessment. This study completed the meta-analysis with an extensive assessment of the evidence. RCTs published from 1994 to 2016 on DSP and ISDN in treating angina pectoris for at least 4 weeks were included. The risk of bias (RoB) of included RCTs was assessed with the Cochrane's tool for assessing RoB. Meta-analyses based on a random-effects model were performed on two outcome measures: symptomatic (SYM) and electrocardiography (ECG) improvements. Subgroup analysis, sensitivity analysis, metaregression, and publication bias analysis were also conducted. The evidence strength was evaluated with the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) method. Among the included 109 RCTs with 11,973 participants, 49 RCTs and 5042 participants were new (after 2010). The RoB of included RCTs was high in randomization and blinding. Overall effect sizes in odds ratios for DSP over ISDN were 2.94 (95% confidence interval [CI]: 2.53-3.41) on SYM (n = 108) and 2.37 (95% CI: 2.08-2.69) by ECG (n = 81) with significant heterogeneities (I2 = 41%, p < 0.0001 on SYM and I2 = 44%, p < 0.0001 on ECG). Subgroup, sensitivity, and metaregression analyses showed consistent results without publication bias. However, the evidence strength was low in GRADE. The efficacy of DSP was still better than ISDN in treating angina pectoris, but the confidence decreased due to high RoB and heterogeneities.
Full Text Available Abstract Background A disturbed circadian rhythm seems to be a causal factor in the occurrence of depressive disorders in patients with Parkinson’s disease (PD. The circadian rhythm can be restored with light. Therefore, Bright Light Therapy (BLT might be a new treatment option for depression in PD patients. Methods/design In this double-blind controlled trial, 84 subjects with idiopathic PD are randomized to either BLT or a control light condition. The BLT condition emits white light with an intensity of 10,000 Lux, while the control device emits dim white light of 200 Lux, which is presumed to be too low to influence the circadian rhythm. Subjects receive 30 min of home treatment twice daily for three months. Timing of treatment is based on the individual chronotype. After finishing treatment, subjects enter a follow-up period of six months. The primary outcome of the study is the severity of depressive symptoms, as measured with the Hamilton Depression Rating Scale. Secondary outcomes are alternative depression measures, objective and subjective sleep measures, and salivary melatonin and cortisol concentrations. For exploratory purposes, we also assess the effects on motor symptoms, global cognitive function, comorbid psychiatric disorders, quality of life and caregiver burden. Data will be analyzed using a linear mixed models analysis. Discussion Performing a placebo-controlled trial on the effects of BLT in PD patients is challenging, as the appearance of the light may provide clues on the treatment condition. Moreover, fixed treatment times lead to an improved sleep-wake rhythm, which also influences the circadian system. With our study design, we do not compare BLT to placebo treatment, i.e. an ineffective control treatment. Rather, we compare structuring of the sleep-wake cycle in both conditions with additional BLT in the experimental condition, and additional dim light in the control condition. Participants are not informed about
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
Full Text Available Abstract Background 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. Methods/Design 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. Conclusions 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. Trial registration Clinicaltrials.gov Identifier NCT01046942
The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial.
Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent; Gluud, Christian; Jobes, David A; Nordentoft, Merete
In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personality disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual. The trial is designed as a single-center, two-armed, parallel-group observer-blinded randomized clinical superiority trial. We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention, Capital Region of Denmark. Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence. The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy, where the duration treatment will vary in accordance with established methods up to 16 weeks. The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective
Karriem H. Ali
Full Text Available Background: Rice Bran Arabinoxylan Compound (RBAC is a nutritional supplement produced by enzymatic hydrolysis of hemicellulose B derived from rice bran. Several in vitro studies and clinical reports have shown RBAC to possess promising immunomodulating effects, specifically with respect to natural killer cell and cytokine activity. The concept of a true immunomodulator is an agent possessing a broad range of activity dependent upon the existing state of health and immunity in the individual host. The present study investigated the immunomodulatory effect of RBAC in a healthy adult human population over 60 days by assessing changes in natural killer cell cytotoxicity (NKCC and cytokines and growth factors. Subjects participated in a two-group, randomized intervention, where one group (n=10 consumed 1 gram/day and the other (n=10 consumed 3 gram/day. Safety and tolerability of RBAC were assessed with total bilirubin, total protein, creatinine, and liver function tests.Results: We found that both groups had similar responses for NKCC, cytokines, and growth factors. The NKCC peaked at 1 week, whereas interferon-γ, tumor necrosis factor-α, interleukins-1α, -1β, -8, and -10, and epidermal growth factor peaked at 30 days. All subjects tolerated the supplement without any adverse reactions.Conclusions: Our results showed transient, bi-directional, immune marker effects consistent with true, multifactorial immunomodulation rather than simply immunostimulation or immunosuppression. Given our findings, the immunomodulatory activity of RBAC merits studyFunctional Foods in Health and Disease 2012, 2(7:265-279 in conditions where the immune system is functionally compromised (e.g., otherwise-healthy smokers and HIV/AIDS or cancer patients. RBAC may not only help to destroy tumor cells and viruses directly, but also increase the activity of immune cells, thereby optimizing the immune system, especially NKCC, which can increase the chance and speed of host
Das, Mrinmay; Jain, Raka; Dhawan, Anju; Kaur, Amandeep
Tramadol is a widely used opioid analgesic. Different preclinical, clinical, and postmarketing surveillance studies show conflicting results regarding abuse potential of this drug. A randomized double-blind complete crossover study was conducted at National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi. Total subjects were 10, comprising total 120 observations (each subject assessed at baseline, 5, 45, and 240 minutes). Subjects with history of substance abuse were included after detoxification and informed consent. Assessment was done using modified single dose opiate questionnaire, morphine benzedrine group (MBG), pentobarbital chlorpromazine alcohol group (PCAG), and two bipolar visual analogue scales (VAS) after administration of three drugs-Tramadol (100 mg), Buprenorphine (0.6 mg), and Placebo (Normal Saline) intramuscularly, at 5-day interval. In intra-group analysis, there was statistically significant increase in scores of all four scales from baseline to all three time points after Tramadol and Buprenorphine administration. In inter-group analysis, statistically higher scores were seen for Buprenorphine in comparison to Tramadol at 5, 45, and 240 minutes for MBG scale; the score was significantly higher for Buprenorphine in VAS for pleasurable effect at 45 and 240 minutes, but not at baseline and 5 minutes. There was no significant difference in score at any point of time between Tramadol and Buprenorphine in PCAG scale and VAS for sedative/alertness effect. The scores were statistically insignificant in case of Placebo. All the subjects liked Buprenorphine most and then Tramadol followed by Placebo. Tramadol has abuse potential (even in therapeutic doses) more than Placebo but less than or comparable to Buprenorphine.
Sampson, Elizabeth L; Jones, Louise; Thuné-Boyle, Ingela C V; Kukkastenvehmas, Riitta; King, Michael; Leurent, Baptiste; Tookman, Adrian; Blanchard, Martin R
Patients with advanced dementia often receive poor end-of-life care. We aimed to design and pilot a palliative care and advance care plan (ACP) intervention. Patients had undergone emergency hospital admission and had severe dementia. The intervention consisted of a palliative care patient assessment which informed an ACP discussion with the carer, who was offered the opportunity to write an ACP for the person with dementia. Carer-patient dyads were randomized to 'usual care' or the intervention. Carer-related outcome measures included the Kessler Distress Scale, Decision Satisfaction Inventory, Client Satisfaction Questionnaire and the Euroqol-5D, measured at baseline, six weeks, six months and three months after bereavement. The Satisfaction with End of Life Care in Dementia Scale was completed if the patient died. The 32 patient participants were physically frail and in the advanced stages of dementia: 62% had pressure damage to the skin, all needed feeding assistance and 95% were in pain. Nearly 50% died during the six-month follow-up period. Carers were difficult to recruit during acute admission; 33 patients and carers entered the study (22 intervention arm; 11 control arm). Only seven carers made ACPs. The care planning discussion was well received, but few carers wrote an ACP, despite intensive support from an experienced nurse specialist. Advance care planning is, in theory, a necessary intervention for people with severe dementia; the reluctance of carers to write plans needs to be explored further.
Ahmadizar, Fariba; Onland-Moret, N Charlotte|info:eu-repo/dai/nl/26504362X; de Boer, Anthonius; Liu, Geoffrey; Maitland-van der Zee, Anke H
AIM: To evaluate the efficacy and safety of bevacizumab in the adjuvant cancer therapy setting within different subset of patients. METHODS & DESIGN/ RESULTS: PubMed, EMBASE, Cochrane and Clinical trials.gov databases were searched for English language studies of randomized controlled trials
Ahmadizar, Fariba|info:eu-repo/dai/nl/369491440; Onland-Moret, N. Charlotte; De Boer, Anthonius|info:eu-repo/dai/nl/075097346; Liu, Geoffrey; Maitland-Van Der Zee, Anke H.|info:eu-repo/dai/nl/255164688
Aim: To evaluate the efficacy and safety of bevacizumab in the adjuvant cancer therapy setting within different subset of patients. Methods & Design/Results: PubMed, EMBASE, Cochrane and Clinical trials.gov databases were searched for English language studies of randomized controlled trials
Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial
Suijker Jacqueline J
Full Text Available Abstract Background Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this study is to investigate whether functional decline in community-dwelling older persons can be delayed or prevented by a comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination. Methods/Design In a cluster randomized controlled trial, with the general practice as the unit of randomization, 1281 participants from 25 general practices will be enrolled in each condition to compare the intervention with usual care. The intervention will focus on older persons who are at increased risk for functional decline, identified by an Identification of Seniors at Risk Primary Care (ISAR-PC score (≥ 2. These older persons will receive a comprehensive geriatric assessment, an individually tailored care and treatment plan, consisting of multifactorial, evidence-based interventions and subsequent nurse-led care coordination. The control group will receive 'care as usual' by the general practitioner (GP. The main outcome after 12 months is the level of physical functioning on the modified Katz-15 index score. The secondary outcomes are health-related quality of life, psychological and social functioning, healthcare utilization and institutionalization. Furthermore, a process evaluation and cost-effectiveness analysis will be performed. Discussion This study will provide new knowledge regarding the effectiveness and feasibility of a comprehensive geriatric assessment, multifactorial interventions and nurse-led elderly care in general practice. Trial registration NTR2653 Grant Unrestricted grant 'The Netherlands Organisation for Health Research and development' no 313020201
Full Text Available To assess the impact of a standardized pre-operative telephone checklist on the rate of late cancellations of ambulatory surgery (AMBUPROG trial.Multicenter, two-arm, parallel-group, open-label randomized controlled trial.11 university hospital ambulatory surgery units in Paris, France.Patients scheduled for ambulatory surgery and able to be reached by telephone.A 7-item checklist designed to prevent late cancellation, available in five languages and two versions (for children and adults, was administered between 7 and 3 days before the planned date of surgery, by an automated phone system or a research assistant. The control group received standard management alone.Rate of cancellation on the day of surgery or the day before.The study population comprised 3900 patients enrolled between November 2012 and September 2013: 1950 patients were randomized to the checklist arm and 1950 patients to the control arm. The checklist was administered to 68.8% of patients in the intervention arm, 1002 by the automated phone system and 340 by a research assistant. The rate of late cancellation did not differ significantly between the checklist and control arms (109 (5.6% vs. 113 (5.8%, adjusted odds ratio [95% confidence interval] = 0.91 [0.65-1.29], (p = 0.57. Checklist administration revealed that 355 patients (28.0% had not undergone tests ordered by the surgeon or anesthetist, and that 254 patients (20.0% still had questions concerning the fasting state.A standardized pre-operative telephone checklist did not avoid late cancellations of ambulatory surgery but enabled us to identify several frequent causes.ClinicalTrials.gov NCT01732159.
Hróbjartsson, A; Boutron, I
Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...
Bendtsen, Preben; Bendtsen, Marcus; Karlsson, Nadine; White, Ian R; McCambridge, Jim
Previous research on the effectiveness of online alcohol interventions for college students has shown mixed results. Small benefits have been found in some studies and because online interventions are inexpensive and possible to implement on a large scale, there is a need for further study. This study evaluated the effectiveness of national provision of a brief online alcohol intervention for students in Sweden. Risky drinkers at 9 colleges and universities in Sweden were invited by mail and identified using a single screening question. These students (N=1605) gave consent and were randomized into a 2-arm parallel group randomized controlled trial consisting of immediate or delayed access to a fully automated online assessment and intervention with personalized feedback. After 2 months, there was no strong evidence of effectiveness with no statistically significant differences in the planned analyses, although there were some indication of possible benefit in sensitivity analyses suggesting an intervention effect of a 10% reduction (95% CI -30% to 10%) in total weekly alcohol consumption. Also, differences in effect sizes between universities were seen with participants from a major university (n=365) reducing their weekly alcohol consumption by 14% (95% CI -23% to -4%). However, lower recruitment than planned and differential attrition in the intervention and control group (49% vs 68%) complicated interpretation of the outcome data. Any effects of current national provision are likely to be small and further research and development work is needed to enhance effectiveness. International Standard Randomized Controlled Trial Number (ISRCTN): 02335307; http://www.isrctn.com/ISRCTN02335307 (Archived by WebCite at http://www.webcitation.org/6ZdPUh0R4).
Rutten, Sonja; Vriend, Chris; Smit, Jan H; Berendse, Henk W; Hoogendoorn, Adriaan W; van den Heuvel, Odile A; van der Werf, Ysbrand D
A disturbed circadian rhythm seems to be a causal factor in the occurrence of depressive disorders in patients with Parkinson's disease (PD). The circadian rhythm can be restored with light. Therefore, Bright Light Therapy (BLT) might be a new treatment option for depression in PD patients. In this double-blind controlled trial, 84 subjects with idiopathic PD are randomized to either BLT or a control light condition. The BLT condition emits white light with an intensity of 10,000 Lux, while the control device emits dim white light of 200 Lux, which is presumed to be too low to influence the circadian rhythm. Subjects receive 30 min of home treatment twice daily for three months. Timing of treatment is based on the individual chronotype. After finishing treatment, subjects enter a follow-up period of six months. The primary outcome of the study is the severity of depressive symptoms, as measured with the Hamilton Depression Rating Scale. Secondary outcomes are alternative depression measures, objective and subjective sleep measures, and salivary melatonin and cortisol concentrations. For exploratory purposes, we also assess the effects on motor symptoms, global cognitive function, comorbid psychiatric disorders, quality of life and caregiver burden. Data will be analyzed using a linear mixed models analysis. Performing a placebo-controlled trial on the effects of BLT in PD patients is challenging, as the appearance of the light may provide clues on the treatment condition. Moreover, fixed treatment times lead to an improved sleep-wake rhythm, which also influences the circadian system. With our study design, we do not compare BLT to placebo treatment, i.e. an ineffective control treatment. Rather, we compare structuring of the sleep-wake cycle in both conditions with additional BLT in the experimental condition, and additional dim light in the control condition. Participants are not informed about the exact details of the two light devices and the expected
Röthlin, Philipp; Birrer, Daniel; Horvath, Stephan; Grosse Holtforth, Martin
Struggling to deliver performance in competitions is one of the main reasons why athletes seek the advice of sport psychologists. Psychologists apply a variety of intervention techniques, many of which are not evidence-based. Evidence-based techniques promote quality management and could help athletes, for example, to increase and maintain functional athletic behavior in competitions/games (i.e., being focused on task relevant cues and executing movements and actions in high quality). However, well-designed trials investigating the effectiveness of sport psychological interventions for performance enhancement are scarce. The planed study is founded by the Swiss National Science Foundation and examines the effectiveness of two interventions with elite and sub-elite athletes. A psychological skills training (PST) and a mindfulness-based intervention (MI), administered as group-program, will be compared to a waiting-list control group concerning how they enhance functional athletic behavior - which is a prerequisite for optimal performance. Furthermore, we will investigate underlying mechanisms (mediators) and moderators (e.g., task difficulty, individual characteristics, intervention-expectancy and intervention-integrity). The presented trial uses a randomized controlled design with three groups, comparing PST, MI and a waiting list control condition. Both group interventions will last 5 weeks, consist of four 2 h sessions and will be administered by a trained sport psychologist. Primary outcome is functional athletic behavior assessed using ambulatory assessment in a competition/game. As secondary outcomes competition anxiety, cognitive interference and negative outcome expectations will be assessed. Assessments are held at pre- and post-intervention as well as at 2 months follow up. The study has been approved by the ethical committee of the Swiss Federal Institute of Sport. Both PST and MI are expected to help improve functional behavior in athletes. By
Kjaergard, Lise L; Gluud, Christian
The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985......-1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index...... that positive trials are cited significantly more often than negative trials. The association was not explained by disease area or methodological quality....
Kaiser, Lee D
Randomization models are useful in supporting the validity of linear model analyses applied to data from a clinical trial that employed randomization via permuted blocks. Here, a randomization model for clinical trials data with arbitrary randomization methodology is developed, with treatment effect estimators and standard error estimators valid from a randomization perspective. A central limit theorem for the treatment effect estimator is also derived. As with permuted-blocks randomization, a typical linear model analysis provides results similar to the randomization model results when, roughly, unit effects display no pattern over time. A key requirement for the randomization inference is that the unconditional probability that any patient receives active treatment is constant across patients; when this probability condition is violated, the treatment effect estimator is biased from a randomization perspective. Most randomization methods for balanced, 1 to 1, treatment allocation satisfy this condition. However, many dynamic randomization methods for planned unbalanced treatment allocation, like 2 to 1, do not satisfy this constant probability condition, and these methods should be avoided. Copyright © 2012 John Wiley & Sons, Ltd.
Gates, P E; Banks, D; Johnston, T E; Campbell, S R; Gaughan, J P; Ross, S A; Engsberg, J R; Tucker, C
A multi-site Randomized-Controlled Trial compared a home-based Supported Speed Treadmill Training Exercise Program (SSTTEP) with a strengthening exercise program in children with cerebral palsy (CP) on the following categories; Participation, quality of life (QOL), self-concept, goal attainment, and satisfaction. Twenty-six children with spastic cerebral palsy were assigned by site-based block randomization to the SSTTEP (n=14) or strengthening exercise (n=12) group. Both groups participated in a two week clinic-based induction period and continued the intervention at home for ten weeks. Data were collected at baseline, post-intervention (12 weeks), and follow-up (16 weeks). Assessments included the Canadian Occupational Performance Measure, Children's Assessment of Participation and Enjoyment Scale, Pediatric Quality of Life Cerebral Palsy Module, and Piers-Harris Children's Self-Concept Scale. Evaluators were blinded to group assignment at two sites. Satisfaction and performance on individual goals, participation, and parent-reported QOL improved in both groups with improvement maintained for four weeks post intervention. The hypothesis that the SSTTEP group would have better outcomes than the exercise group was not supported. However, both groups showed that children with CP can make gains in participation, individual goals, and satisfaction following a 12-week intensive exercise intervention, and these findings persisted for four weeks post intervention.
Thabrew, Hiran; Corter, Arden; Goodyear-Smith, Felicity; Goldfinch, Mary
Psychosocial problems such as depression, anxiety, and substance abuse are common and burdensome in young people, particularly those with long-term physical conditions such as asthma and diabetes. In New Zealand, "screening" for such problems is undertaken routinely only with Year 9 students in low-decile schools and opportunistically in pediatric settings using a nonvalidated and time-consuming clinician-administered Home, Education/employment, Eating, Activity, Drugs, Sexuality, Suicide/depression, Safety (HEEADSSS) interview. The Youth version, Case-finding and Help Assessment Tool (YouthCHAT) is a relatively new, locally developed, eTablet-based composite screener for identifying similar psychosocial issues to HEEADSSS. Based on individually validated screening instruments, it is self-administered within minutes. Preliminary testing has revealed its acceptability to young people, but further research is required to expand its modules to cover all HEEADSSS domains, to evaluate its acceptability for young people with and without long-term physical conditions, and to compare its effectiveness against HEEADSSS. Our aim is to (1) ascertain acceptability and utility of YouthCHAT for children with long-term physical illness and high school students, (2) validate three additional YouthCHAT domains against comparable HEEADSSS domains, and (3) compare the performance of YouthCHAT and HEEADSSS in the high school setting. During the first phase of the study, three additional YouthCHAT domains were codesigned with high school students. During the second phase of the study, the updated version of YouthCHAT will be administered to 30 young people with long-term physical conditions, and to 150 high school students either before or after HEEADSSS in the form of a randomized trial with counter-balanced design. Primary outcomes include comparability between HEEADSSS and YouthCHAT in detecting psychosocial issues, and time to administer; acceptability of YouthCHAT as an acceptable
Jo, Booil; Asparouhov, Tihomir; Muthen, Bengt O.; Ialongo, Nicholas S.; Brown, C. Hendricks
Cluster randomized trials (CRTs) have been widely used in field experiments treating a cluster of individuals as the unit of randomization. This study focused particularly on situations where CRTs are accompanied by a common complication, namely, treatment noncompliance or, more generally, intervention nonadherence. In CRTs, compliance may be…
Clare L Atzema
Full Text Available BACKGROUND: Emergency department discharge instructions are variably understood by patients, and in the setting of emergency department crowding, innovations are needed to counteract shortened interaction times with the physician. We evaluated the effect of viewing an online video of diagnosis-specific discharge instructions on patient comprehension and recall of instructions. METHODS: In this prospective, single-center, randomized controlled trial conducted between November 2011 and January 2012, we randomized emergency department patients who were discharged with one of 38 diagnoses to either view (after they left the emergency department a vetted online video of diagnosis-specific discharge instructions, or to usual care. Patients were subsequently contacted by telephone and asked three standardized questions about their discharge instructions; one point was awarded for each correct answer. Using an intention-to-treat analysis, differences between groups were assessed using univariate testing, and with logistic regression that accounted for clustering on managing physician. A secondary outcome measure was patient satisfaction with the videos, on a 10-point scale. RESULTS: Among 133 patients enrolled, mean age was 46.1 (s.d.D. 21.5 and 55% were female. Patients in the video group had 19% higher mean scores (2.5, s.d. 0.7 than patients in the control group (2.1, s.d. 0.8 (p=0.002. After adjustment for patient age, sex, first language, triage acuity score, and clustering, the odds of achieving a fully correct score (3 out of 3 were 3.5 (95% CI, 1.7 to 7.2 times higher in the video group, compared to the control group. Among those who viewed the videos, median rating of the videos was 10 (IQR 8 to 10. CONCLUSIONS: In this single-center trial, patients who viewed an online video of their discharge instructions scored higher on their understanding of key concepts around their diagnosis and subsequent care. Those who viewed the videos found them to
Full Text Available Abstract Background Although most patients with low back pain (LBP recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking. Methods/Design This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave. Discussion This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice. Trial registration ISRCTN 68205910
Full Text Available The bacterial genus Shigella is the leading cause of dysentery. There have been significant increases in the proportion of Shigella isolated that demonstrate resistance to nalidixic acid. While nalidixic acid is no longer considered as a therapeutic agent for shigellosis, the fluoroquinolone ciprofloxacin is the current recommendation of the World Health Organization. Resistance to nalidixic acid is a marker of reduced susceptibility to older generation fluoroquinolones, such as ciprofloxacin. We aimed to assess the efficacy of gatifloxacin versus ciprofloxacin in the treatment of uncomplicated shigellosis in children.We conducted a randomized, open-label, controlled trial with two parallel arms at two hospitals in southern Vietnam. The study was designed as a superiority trial and children with dysentery meeting the inclusion criteria were invited to participate. Participants received either gatifloxacin (10 mg/kg/day in a single daily dose for 3 days or ciprofloxacin (30 mg/kg/day in two divided doses for 3 days. The primary outcome measure was treatment failure; secondary outcome measures were time to the cessation of individual symptoms. Four hundred and ninety four patients were randomized to receive either gatifloxacin (n=249 or ciprofloxacin (n=245, of which 107 had a positive Shigella stool culture. We could not demonstrate superiority of gatifloxacin and observed similar clinical failure rate in both groups (gatifloxacin; 12.0% and ciprofloxacin; 11.0%, p=0.72. The median (inter-quartile range time from illness onset to cessation of all symptoms was 95 (66-126 hours for gatifloxacin recipients and 93 (68-120 hours for the ciprofloxacin recipients (Hazard Ratio [95%CI]=0.98 [0.82-1.17], p=0.83.We conclude that in Vietnam, where nalidixic acid resistant Shigellae are highly prevalent, ciprofloxacin and gatifloxacin are similarly effective for the treatment of acute shigellosis.
Sanclemente, G; Medina, L; Villa, J-F; Barrera, L-M; Garcia, H-I
To date, there is no gold standard therapy for skin photoageing. In the last decade, laser technologies have offered great promise among skin-rejuvenation therapies; however, both non-ablative and ablative fractional resurfacing modalities have their own benefits and drawbacks. More recently, open-label studies and few controlled trials have suggested that photodynamic therapy may have therapeutic potential in photodamage. To assess the efficacy of methyl aminolevulinate + red-light on facial photodamage in a double-blind split-face randomized placebo-controlled trial. Subjects had initially two split-face treatments 2-3 weeks apart in which half of the face was treated with MAL + red-light compared with placebo + red-light. Primary outcome was the assessment of global photodamage 1 month after session 2. Secondary outcomes included the assessment of fine lines, mottled pigmentation, tactile roughness, sallowness, erythema and telangiectasia 1 month after session 2, according to severity scores rated as failure, improvement or success. Based on the intention-to-treat analysis, a total of 48 patients (96 split-faces) were included. Facial global photodamage success or improvement had occurred in 94 split-faces and in no split-faces receiving placebo (RR: 0.02; 95% confidence interval, 0.0-0.14; P = 0.0000). One patient had an adverse event that led to the discontinuation of the therapy after session 1. Methyl aminolevulinate + red-light demonstrated significantly superior efficacy in global facial photodamage compared with placebo. This therapy was also useful for all other specific secondary outcomes, except for telangiectasia. Overall, MAL + red-light sessions were well tolerated and resulted in high/total patient satisfaction in the majority of subjects (80.4%). © 2010 The Authors. Journal of the European Academy of Dermatology and Venereology © 2010 European Academy of Dermatology and Venereology.
Pillai, Praveen; McEleavy, Irene; Gaughan, Matthew; Snowden, Christopher; Nesbitt, Ian; Durkan, Garrett; Johnson, Mark; Cosgrove, Joseph; Thorpe, Andrew
Cardiovascular optimization via esophageal Doppler can minimize gastrointestinal hypoperfusion, reducing the risk of multiple organ dysfunction and postoperative complications during major surgery. We assessed the effect of esophageal Doppler guided cardiovascular optimization in patients undergoing radical cystectomy. We conducted a prospective, randomized, double-blind controlled trial at a United Kingdom teaching hospital between 2006 and 2009. A total of 66 patients were randomized to a control arm (34) and an intervention arm (32). The control group received standard intraoperative fluids. The intervention group received (additional) Doppler guided fluid. Primary outcomes were markers of gastrointestinal morbidity such as ileus, flatus and bowel opening. Secondary outcomes were postoperative nausea and vomiting, wound infection and operative intravenous fluid volumes (total and hourly). There were significant reductions in the control and intervention arms in the incidence of ileus (18 vs 7, p Doppler significantly improved postoperative markers of gastrointestinal function. Copyright Â© 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Cheung, Peter P; Lahiri, Manjari; Teng, Gim Gee; Lim, Anita Y N; Lau, Tang Ching; Lateef, Aisha; Mak, Anselm; Gossec, Laure; March, Lyn
Patients can potentially monitor disease activity of RA through self-assessed swollen joints (clinical synovitis), but reliability is poor. The objective is to evaluate the use of education by US feedback on the ability of patients to assess for clinical synovitis in RA. We performed a 6 month, single-centre, randomized controlled trial on patients with established RA to study the effect of education on self-assessment of joints that included initial brief patient training on tender (TJC) and swollen (SJC) joint counts followed by US feedback every 3 months vs standard care without education. Patient and physician independently performed 28-joint counts at each visit. Outcome variables included the percentage of patients with good agreement with physician-derived swollen joints [prevalence-adjusted bias-adjusted kappa (PABAK) >0.6] as well as agreement in the SJC (Bland and Altman 95% limits of agreement), feasibility/patient satisfaction survey and disease activity at 6 months. Of the 101 randomized patients, 95 were included (51 in the education arm and 44 in the standard care arm). At 6 months there was a significant difference in the proportion of patients with swollen joint PABAK >0.6 in the education arm compared with standard care (98 vs 85%, P = 0.02). Limits of agreement for the SJC difference between physician and patients were reduced only in the education arm. The training method is considered feasible, with 94% of patients reporting it as useful. A trend of higher rates of disease remission (28-joint DAS <2.6) in the education arm vs standard care (47% vs 29%, P = 0.07) was seen. A short course of education with US feedback may be helpful in educating patients to assess for clinical synovitis. Clinical trials.gov, https://clinicaltrials.gov, NCT02351401. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: firstname.lastname@example.org.
Full Text Available INTRODUCTION: More than 80% of schistosomiasis patients in China live in the lake and marshland regions. The purpose of our study is to assess the effect of a comprehensive strategy to control transmission of Schistosoma japonicum in marshland regions. METHODOLOGY/PRINCIPAL FINDINGS: In a cluster randomized controlled trial, we implemented an integrated control strategy in twelve villages from 2009 through 2011 in Gong'an County, Hubei Province. The routine interventions included praziquantel chemotherapy and controlling snails, and were implemented in all villages. New interventions, mainly consisting of building fences to limit the grazing area for bovines, building safe pastures for grazing, improving the residents' health conditions and facilities, were only implemented in six intervention villages. Results showed that the rate of S. japonicum infection in humans, bovines, snails, cow dung and mice in the intervention group decreased from 3.41% in 2008 to 0.81% in 2011, 3.3% to none, 11 of 6,219 to none, 3.9% to none and 31.7% to 1.7%, respectively (P0.05 for all comparisons. Moreover, a generalized linear model showed that there was a higher infection risk in humans in the control group than in the intervention group (OR = 1.250, P = 0.001 and an overall significant downward trend in infection risk during the study period. CONCLUSIONS/SIGNIFICANCE: The integrated control strategy, designed to reduce the role of bovines and humans as sources of S. japonicum infection, was highly effective in controlling the transmission of S. japonicum in marshland regions in China. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-PRC-12002405.
Walker, Gemma M; Armstrong, Sarah; Gordon, Adam L; Gladman, John; Robertson, Kate; Ward, Marie; Conroy, Simon; Arnold, Gail; Darby, Janet; Frowd, Nadia; Williams, Wynne; Knowles, Sue; Logan, Pip A
Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records. PMID:26385358
Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial.
Suijker, Jacqueline J; Buurman, Bianca M; ter Riet, Gerben; van Rijn, Marjon; de Haan, Rob J; de Rooij, Sophia E; Moll van Charante, Eric P
Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this study is to investigate whether functional decline in community-dwelling older persons can be delayed or prevented by a comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination. In a cluster randomized controlled trial, with the general practice as the unit of randomization, 1281 participants from 25 general practices will be enrolled in each condition to compare the intervention with usual care. The intervention will focus on older persons who are at increased risk for functional decline, identified by an Identification of Seniors at Risk Primary Care (ISAR-PC) score (≥ 2). These older persons will receive a comprehensive geriatric assessment, an individually tailored care and treatment plan, consisting of multifactorial, evidence-based interventions and subsequent nurse-led care coordination. The control group will receive 'care as usual' by the general practitioner (GP). The main outcome after 12 months is the level of physical functioning on the modified Katz-15 index score. The secondary outcomes are health-related quality of life, psychological and social functioning, healthcare utilization and institutionalization. Furthermore, a process evaluation and cost-effectiveness analysis will be performed. This study will provide new knowledge regarding the effectiveness and feasibility of a comprehensive geriatric assessment, multifactorial interventions and nurse-led elderly care in general practice. NTR2653 GRANT: Unrestricted grant 'The Netherlands Organisation for Health Research and development' no 313020201.
G Michael Allan
Full Text Available BACKGROUND: Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. METHODS AND FINDINGS: We randomly sampled 188 RCTs spanning three years (2003-2005 from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188 of RCTs; any actual costs were included in 7.4% (14/188 of RCTs; and any mention of costs was included in 27.7% (52/188 of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005 and any mention of costs (Cochran-Armitage test, p = 0.02. Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009 or any mention of costs (OR = 0.63, p = 0.02. Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. CONCLUSION: While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.
Dulmen, S.A. van; Maas, Marjo; Staal, J.B.; Rutten, G.; Kiers, H.; Nijhuis-Van der Sanden, M.W.G.; Wees, P. van der
BACKGROUND: Clinical practice guidelines are considered important instruments to improve quality of care. However, success is dependent on adherence, which may be improved using peer assessment, a strategy in which professionals assess performance of their peers in a simulated setting. OBJECTIVE:
Naunheim, Matthew R; Walcott, Brian P; Nahed, Brian V; Simpson, Andrew K; Agarwalla, Pankaj K; Coumans, Jean-Valery
Retrospective literature review. To assess the quality of randomized controlled trial reporting in spine surgery. The use of the Consolidated Standards of Reporting Trials (CONSORT) criteria in clinical trials aims to improve adherence to a set of generally accepted practices in the reporting of randomized controlled trials. Randomized controlled trials in spine surgery are important sources of evidence-based practice, but the quality of their execution and reporting have not been reported adequately. All randomized controlled trials published in three selected dedicated spine journals from 2008 were reviewed with respect to the 40 criteria derived from CONSORT descriptors; 10 criteria applying to the abstract, and 30 to the body of the article. Each article was scored by three reviewers in group format for each criterion and was assigned a score. Reviewers always came to a consensus before assigning a score. A total of 32 RCTs met the inclusion criteria for this review. The average modified CONSORT score was 65%. Disclosing certain criteria was associated with a higher overall score, including method of generation of random sequence (P spine literature may thus be difficult to interpret. Greater effort must be put into compliance with these guidelines to improve data quality.
Erbe, Christina; Klukowska, Malgorzata; Tsaknaki, Iris; Timm, Hans; Grender, Julie; Wehrbein, Heinrich
Good oral hygiene is a challenge for orthodontic patients because food readily becomes trapped around the brackets and under the archwires, and appliances are an obstruction to mechanical brushing. The purpose of this study was to compare plaque removal efficacy of 3 toothbrush treatments in orthodontic subjects. This was a replicate-use, single-brushing, 3-treatment, examiner-blind, randomized, 6-period crossover study with washout periods of approximately 24 hours between visits. Forty-six adolescent and young adult patients with fixed orthodontics from a university clinic in Germany were randomized, based on computer-generated randomization, to 1 of 3 treatments: (1) oscillating-rotating electric toothbrush with a specially designed orthodontic brush head (Oral-B Triumph, OD17; Procter & Gamble, Cincinnati, Ohio); (2) the same electric toothbrush handle with a regular brush head (EB25; Procter & Gamble); and (3) a regular manual toothbrush (American Dental Association, Chicago, Ill). The primary outcome was the plaque score change from baseline, which we determined using digital plaque image analysis. Forty-five subjects completed the study. The differences in mean plaque removal (95% confidence interval) between the electric toothbrush with an orthodontic brush head (6% [4.4%-7.6%]) or a regular brush head (3.8% [2.2%-5.3%]) and the manual toothbrush were significant (P Plaque removal with the electric toothbrush with the orthodontic brush head was superior (2.2%; P = 0.007) to the regular brush head. No adverse events were seen. The electric toothbrush, with either brush head, demonstrated significantly greater plaque removal over the manual brush. The orthodontic brush head was superior to the regular head. Copyright © 2013 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.
Annalouise O’Connor; Corbin, Karen D.; Nieman, David C.; Swick, Andrew G.
ABSTRACTBackground: Thermogenic ingredients may play a role in weight management. In vitro and rodent work suggests that components of black pepper may impact energy expenditure, and in humans, other TPRV1 agonists e.g. capsaicin, augment EE. Objectives: To determine the impact of BP on 24-hour EE, respiratory quotient, and biochemical markers of metabolism and satiety, a randomized, controlled, cross-over study of black pepper (0.5mg/meal) versus no pepper control was conducted in post-menop...
Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho – a randomized controlled trial (CASCADE trial
Niklaus Daniel Labhardt
Full Text Available Abstract Background Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation. Methods This two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test. The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms. Discussion This trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow
Di Cesare, Franco; Mancuso, Jessica; Silver, Brian; Loudon, Peter T
Objective. Ischemic stroke is a serious medical condition with limited therapeutic options. The evaluation of the therapeutic potential of novel pharmacological interventions is carried-out in Phase II trials. The study design, primarily intended to evaluate efficacy and safety, is a balance between utilizing as few patients as possible to minimize safety risk and enrolling sufficient patients to detect unambiguous efficacy signals. We sought to determine whether post-stroke recovery outcomes based on behavioral measures of cognitive and motor impairment yielded additional information beyond that of clinician-based methods. Design. This was a multicenter, multinational, randomized, parallel group, controlled versus placebo, efficacy, and safety study of PF-03049423 for treatment of acute ischemic stroke. Settings and participants. Our study subjects were acute ischemic stroke inpatients. Measurements. Outcome measures were derived from rating scales (Modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale) and behavioral tests (Box and Blocks Test, Hand Grip Strength Test, 10-Meter Walk Test, Repeatable Battery Assessment of Neuropsychological Status Naming and Coding Subtests, Line Cancellation Test, and Recognition Memory Test). Assessments were performed at Days 7, 14, 30, 60, and 90. Post-hoc analyses of correlations among the outcome measures at each measurement time point on a cohort of 137 subjects were conducted. Results. Results support the validity of measures from Box and Blocks Test, Hand Grip Strength Test, 10-Meter Walk Test, and Repeatable Battery Assessment of Neuropsychological Status Coding Subtests to monitor post-stroke recovery in clinical trial settings. Notably, the Recognition Memory Test did not show a correlation with the Modified Rankin Scale, and, in fact, did not show improvement over time. Conclusion. The behavioral measures of cognitive and motor functions included in this study may extend the evaluation
Peletz, Rachel; Simunyama, Martin; Sarenje, Kelvin; Baisley, Kathy; Filteau, Suzanne; Kelly, Paul; Clasen, Thomas
Unsafe drinking water presents a particular threat to people living with HIV/AIDS (PLHIV) due to the increased risk of opportunistic infections, diarrhea-associated malabsorption of essential nutrients, and increased exposure to untreated water for children of HIV-positive mothers who use replacement feeding to reduce the risk of HIV transmission. This population may particularly benefit from an intervention to improve water quality in the home. We conducted a 12-month randomized, controlled field trial in Zambia among 120 households with children water filter and jerry cans for safe storage. Households were followed up monthly to assess use, drinking water quality (thermotolerant coliforms (TTC), an indicator of fecal contamination) and reported diarrhea (7-day recall) among children filter have been unsuccessful, we also assessed weight-for-age Z-scores (WAZ) as an objective measure of diarrhea impact. Filter use was high, with 96% (596/620) of household visits meeting the criteria for users. The quality of water stored in intervention households was significantly better than in control households (3 vs. 181 TTC/100 mL, respectively, pwater filter combined with safe storage was used correctly and consistently, was highly effective in improving drinking water quality, and was protective against diarrhea. Clinicaltrials.gov NCT01116908.
Lui, Kung-Jong; Chang, Kuang-Chao
When a generic drug is developed, it is important to assess the equivalence of therapeutic efficacy between the new and the standard drugs. Although the number of publications on testing equivalence and its relevant sample size determination is numerous, the discussion on sample size determination for a desired power of detecting equivalence under a randomized clinical trial (RCT) with non-compliance and missing outcomes is limited. In this paper, we derive under the compound exclusion restriction model the maximum likelihood estimator (MLE) for the ratio of probabilities of response among compliers between two treatments in a RCT with both non-compliance and missing outcomes. Using the MLE with the logarithmic transformation, we develop an asymptotic test procedure for assessing equivalence and find that this test procedure can perform well with respect to type I error based on Monte Carlo simulation. We further develop a sample size calculation formula for a desired power of detecting equivalence at a nominal alpha-level. To evaluate the accuracy of the sample size calculation formula, we apply Monte Carlo simulation again to calculate the simulated power of the proposed test procedure corresponding to the resulting sample size for a desired power of 80 per cent at 0.05 level in a variety of situations. We also include a discussion on determining the optimal ratio of sample size allocation subject to a desired power to minimize a linear cost function and provide a sensitivity analysis of the sample size formula developed here under an alterative model with missing at random. Copyright (c) 2007 John Wiley & Sons, Ltd.
Shah, Anand [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Efstathiou, Jason A.; Paly, Jonathan J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Halpern, Scott D. [Department of Medicine, University of Pennsylvania, Philadelphia, PA (United States); Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA (United States); Center for Bioethics, University of Pennsylvania, Philadelphia, PA (United States); Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA (United States); Bruner, Deborah W. [Winship Cancer Institute, Emory University, Atlanta, GA (United States); Christodouleas, John P. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Coen, John J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Deville, Curtiland; Vapiwala, Neha [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Shipley, William U.; Zietman, Anthony L. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Hahn, Stephen M. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Bekelman, Justin E., E-mail: email@example.com [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA (United States)
Purpose: To investigate patients' willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa). Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients' stated WTP was assessed using a 6-point Likert scale. Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients' WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either 'definitely' or 'probably' participate. Seventeen percent (8 of 46) stated they would 'definitely not' or 'probably not' enroll, most of whom (6 of 8) preferred PBT before their physician visit. Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.
Clewell, Amy; Barnes, Matt; Endres, John R; Ahmed, Mansoor; Ghambeer, Daljit K S
Topical Acyclovir has moderate efficacy on recurrent HSV symptoms, requiring repeat applications for several days. Topical Dynamiclear, which requires only a single dose application, may provide a more effective and convenient treatment option for symptomatic management of HSV. The study assessed the comparative efficacy and tolerability of a single use, topical formulation containing copper sulfate pentahydrate and Hypericum perforatum that is marketed as Dynamiclear™ to a topical 5% Acyclovir cream standard preparation and use. A prospective, randomized, multi-centered, comparative, open-label clinical study was conducted. A total of 149 participants between 18 and 55 years of age with active HSV-1 and HSV-2 lesions were recruited for the 14-day clinical trial. Participants were randomized into two groups: A (n=61), those receiving the Dynamiclear formulation, and B (n=59), those receiving 5% Acyclovir. Efficacy parameters were assessed via physical examination at baseline (day 1), day 2, 3, 8, and 14. Laboratory safety tests were conducted at baseline and on day 14. Use of the Dynamiclear formulation was found to have no significant adverse effects and was well tolerated by participants. All hematological and biochemical markers were within normal range for the Dynamiclear group. Statistically, odds for being affected by burning and stinging sensation were 1.9 times greater in the Acyclovir group in comparison to the Dynamiclear group. Similarly, the odds of being affected by symptoms of acute pain, erythema and vesiculation were 1.8, 2.4, and 4.4 times higher in the Acyclovir group in comparison to the Dynamiclear group. The Dynamiclear formulation was well tolerated, and efficacy was demonstrated in a number of measured parameters, which are helpful in the symptomatic management of HSV-1 and HSV-2 lesions in adult patients. Remarkably, the effects seen from this product came from a single application.
Genton, B.; D'Acremont, V.; Lurati-Ruiz, F.; Verhage, D.F.; Audran, R.; Hermsen, C.C.; Wolters, L.; Reymond, C.; Spertini, F.; Sauerwein, R.W.
The aim of this Phase I/IIa double-blind controlled trial was to test the efficacy of the sporozoite-based malaria vaccine PfCS 282-383 (PfCS102) to protect against Plasmodium falciparum parasitaemia. 16 volunteers were randomized to receive twice 30 mug of PfCS102 formulated in Montanide ISA 720 or
Moustgaard, Helene; Bello, Segun; Miller, Franklin G
OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...
Maughan, Ronald J; Watson, Phillip; Cordery, Philip Aa; Walsh, Neil P; Oliver, Samuel J; Dolci, Alberto; Rodriguez-Sanchez, Nidia; Galloway, Stuart Dr
The identification of beverages that promote longer-term fluid retention and maintenance of fluid balance is of real clinical and practical benefit in situations in which free access to fluids is limited or when frequent breaks for urination are not desirable. The postingestion diuretic response is likely to be influenced by several beverage characteristics, including the volume ingested, energy density, electrolyte content, and the presence of diuretic agents. This study investigated the effects of 13 different commonly consumed drinks on urine output and fluid balance when ingested in a euhydrated state, with a view to establishing a beverage hydration index (BHI), i.e., the volume of urine produced after drinking expressed relative to a standard treatment (still water) for each beverage. Each subject (n = 72, euhydrated and fasted male subjects) ingested 1 L still water or 1 of 3 other commercially available beverages over a period of 30 min. Urine output was then collected for the subsequent 4 h. The BHI was corrected for the water content of drinks and was calculated as the amount of water retained at 2 h after ingestion relative to that observed after the ingestion of still water. Total urine masses (mean ± SD) over 4 h were smaller than the still-water control (1337 ± 330 g) after an oral rehydration solution (ORS) (1038 ± 333 g, P sports drink were not different from the response to water ingestion. The mean BHI at 2 h was 1.54 ± 0.74 for the ORS, 1.50 ± 0.58 for full-fat milk, and 1.58 ± 0.60 for skimmed milk. BHI may be a useful measure to identify the short-term hydration potential of different beverages when ingested in a euhydrated state. This trial was registered at www.isrctn.com as ISRCTN13014105. © 2016 American Society for Nutrition.
Hatiboglu, G; Simpfendörfer, T; Uhlmann, L; Bergero, M A; Macher-Goeppinger, S; Pahernik, S; Hadaschik, B; Hohenfellner, M; Teber, D
This study prospectively evaluated the safety and efficacy of perineal hydrodissection in robot assisted nervesparing prostatectomy. Patients were randomized for perineal, ultrasound guided hydrodissection (HD) before radical prostatectomy and compared with standard treatment (ST). Follow-up was done every 3 months, including erectile function (IIEF5-score), reported grade of erection, ability for sexual intercourse, continence, PSA. 21 patients were enrolled to this prospective study, 10 for ST and 11 for HD. No significant differences in demographic and preoperative oncological data between both groups were identified. Blood loss and time for surgery did not differ significantly. HD resulted in 66% (4/6) rate of positive surgical margins (PSM) in pT3 tumors vs 50% in ST (1/2; P = 0.67). Follow-up revealed higher IIEF scores, better ability for sexual intercourse and early continence in HD. Erectile function after radical prostatectomy was improved by perineal hydrodissection in this proof of principal study. However, careful patient selection and further studies are needed as perineal hydrodissection could result in increased positive surgical margins in pT3a tumors. Copyright © 2017 John Wiley & Sons, Ltd.
Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo
Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…
Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian
The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....
Levy-Cooperman, Naama; Schoedel, Kerri A; Chakraborty, Bijan; Blum, David; Cheng, Hailong
Eslicarbazepine acetate (ESL) is a once-daily oral antiepileptic drug for the treatment of partial-onset seizures. Adverse events such as dizziness and somnolence reported in clinical studies suggest that ESL has detectable central nervous system (CNS) effects in addition to its antiepileptic effects. This Phase I study evaluated the abuse liability of ESL compared with that of alprazolam (ALP) and placebo (PBO) in recreational CNS depressant users. In this single-dose, randomized, double-blind, PBO- and active-controlled crossover study, healthy recreational CNS depressant users who could discern between ALP 2mg and PBO received single oral doses of each of the following treatments with a washout interval of ≥7days between each treatment: ESL (800mg, 1600mg, 2000mg, and 2400mg); ALP (1.5mg and 3.0mg); and PBO. Subjective measures, including visual analog scales (VASs) e.g., Drug-Liking (primary endpoint), and Addiction Research Center Inventory (ARCI) Morphine-Benzedrine Group (MBG), Pentobarbital Chlorpromazine Alcohol Group (PCAG), and Lysergic Acid Diethylamide Group scales were evaluated at multiple time points up to 24h postdose. Cognitive effects were evaluated using the Choice Reaction Time (CRT), Divided Attention (DAT) and Hopkins Verbal Learning Task-Revised tests. Peak scores for Drug-Liking VAS (maximum effect [Emax]) were significantly higher for both ALP doses than for PBO (peslicarbazepine, increased with increasing ESL dose. Pharmacokinetic parameters estimated for eslicarbazepine were generally comparable with results from previous studies in healthy volunteers. This study demonstrated that single doses of ESL may have less abuse liability than ALP in recreational sedative users. Although ESL had detectable subjective effects and showed some drug-'liking' at higher doses, the magnitude of these effects was small. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
Bae, Donald S; Valim, Clarissa; Connell, Patricia; Brustowicz, Katherine A; Waters, Peter M
The purpose of this study was to determine the effects of bivalved versus circumferential cast immobilization on maintenance of reduction and associated complications after closed reduction (CR) of radius and/or ulna fractures in children. Two hundred two children with displaced radius and/or ulna fractures were randomized to either circumferential (n=101) or bivalved (n=101) long-arm casts after CR. The mean age was 10±3 years. There were no significant differences between groups in terms of age, sex, or initial fracture displacement or angulation. Clinical and radiographic evaluations were performed at 1, 2, 4, and 6 weeks postreduction. Radiographic loss of reduction (LOR), need for remanipulation or surgery, and associated complications of compartment syndrome, cast saw injury, and neurovascular compromise were recorded. Overall, the median angulation of the radius and ulna fractures improved from 20 and 18 degrees to 3 and 2 degrees after CR, respectively. The median cast index after reduction was 0.78 in the bivalved group and 0.80 in the circumferential group. The median angulation of the radius and ulna was 8 and 1 degrees at 4 weeks, with no significant difference between groups. By the fourth week of follow-up, 70 patients (34%)-35 bivalved and 35 circumferential-had radiographic LOR. Forty-seven patients (23%)-23 bivalved and 24 circumferential-underwent remanipulation or surgical reduction and fixation. There were no significant differences between groups with respect to LOR rate or need for surgical treatment. One bivalved patient sustained a cast saw injury, and 3 bivalved patients had transient neurological abnormalities. No patients developed compartment syndrome. Cast immobilization is effective in the majority of patients after CR of displaced forearm fractures. There were no significant differences in maintenance of reduction, need for surgery, or complications between bivalved or circumferential long-arm casts. Level I-therapeutic.
Geller, Stacie E; Koch, Abigail R; Roesch, Pamela; Filut, Amarette; Hallgren, Emily; Carnes, Molly
The National Institutes of Health (NIH) Revitalization Act of 1993 requires NIH-funded clinical trials to include women and minorities as participants and assess outcomes by sex and race or ethnicity. The objective of this study was to investigate current levels of compliance with these guidelines for inclusion, analysis, and reporting in NIH-funded randomized controlled trials (RCTs) and compare the results with those from 2009 and 2004, which the authors reported previously. The authors identified 782 RCTs published in 14 leading U.S. medical journals in 2015 with a PubMed search. Of those, 142 were the primary report of a NIH-funded RCT, conducted in the United States, and eligible for analysis. The authors reviewed abstract, text, and tables of each eligible study as well as any follow-up published commentary to determine compliance with NIH guidelines. Thirty-five studies limited enrollment to one sex. The median enrollment of women in the remaining 107 studies was 46%, but 16 (15.0%) enrolled less than 30% women. Twenty-eight of the 107 (26%) reported at least one outcome by sex or explicitly included sex as a covariate in statistical analysis. Of the 142 studies, 19 (13.4%) analyzed or reported outcomes by race or ethnicity. There were no statistically significant changes in inclusion, analysis, or reporting by sex, race, or ethnicity compared with the previous studies. NIH policies have not resulted in significant increases in reporting results by sex, race, or ethnicity. The authors recommend strong journal policies to increase compliance with NIH policies.
Oyanguren, Juana; García-Garrido, LLuisa; Nebot Margalef, Magdalena; Lekuona, Iñaki; Comin-Colet, Josep; Manito, Nicolás; Roure, Julia; Ruiz Rodriguez, Pilar; Enjuanes, Cristina; Latorre, Pedro; Torcal Laguna, Jesús; García-Gutiérrez, Susana
Heart failure (HF) is associated with many hospital admissions and relatively high mortality, rates decreasing with administration of beta-blockers (BBs), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists. The effect is dose dependent, suboptimal doses being common in clinical practice. The 2012 European guidelines recommend close monitoring and dose titration by HF nurses. Our main aim is to compare BB doses achieved by patients after 4 months in intervention (HF nurse-managed) and control (cardiologist-managed) groups. Secondary aims include comparing doses of the other aforementioned drugs achieved after 4 months, adverse events, and outcomes at 6 months in the two groups. We have designed a multicentre (20 hospitals) non-inferiority randomized controlled trial, including patients with new-onset HF, left ventricular ejection fraction ≤40%, and New York Heart Association class II-III, with no contraindications to BBs. We will also conduct qualitative analysis to explore potential barriers to and facilitators of dose titration by HF nurses. In the intervention group, HF nurses will implement titration as prescribed by cardiologists, following a protocol. In controls, cardiologists will both prescribe and titrate doses. The study variables are doses of each of the drugs after 4 months relative to the target dose (%), New York Heart Association class, left ventricular ejection fraction, N-terminal pro B-type natriuretic peptide levels, 6 min walk distance, comorbidities, renal function, readmissions, mortality, quality of life, and psychosocial characteristics. The trial seeks to assess whether titration by HF nurses of drugs recommended in practice guidelines is safe and not inferior to direct management by cardiologists. The results could have an impact on clinical practice. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of
Blum, Jennifer; Sheldon, Wendy R; Ngoc, Nguyen Thi Nhu; Winikoff, Beverly; Nga, Nguyen Thi Bach; Martin, Roxanne; Van Thanh, Le; Blumenthal, Paul D
To evaluate the accuracy, feasibility and acceptability of two urine pregnancy tests in assessing abortion outcomes at three time points after mifepristone administration. This randomized trial enrolled women seeking early medical abortion at two hospitals in Vietnam. Investigators randomly allocated participants to at-home administration of a multilevel urine pregnancy test (MLPT) or a high sensitivity urine pregnancy test (HSPT) to assess their abortion outcomes. A baseline test was administered on the same day as mifepristone. Participants performed and interpreted results of pregnancy tests taken 3, 7 and 14days after mifepristone. Ultrasound exam determined continuing pregnancy. Six hundred women enrolled, and 300 received each test. A percentage of 97.4 (584) had follow-up, of whom 13 women had continuing pregnancies. The specificity of MLPT at detecting absence of continuing pregnancy was 63.9%, 90.4% and 97.1% at study day 3, 7 and 14. The specificity of HSPT was 6.0%, 19.8% and 62.2%, respectively. The positive predictive value (PPV) of MLPT at detecting continuing pregnancy was 6.4% at day 3 and rose to 46.7% at day 14. In contrast, the PPV for HSPT was 2.2% at day 3 and rose to 6.5% at day 14. At all three time points, the sensitivity and negative predictive values for both tests were 100.0%. Most women found their assigned tests easy to use and would prefer future home follow-up with a pregnancy test. The MLPT enables women to assess their abortion outcomes more reliably than with HSPT. With MLPT, women can know their outcomes as early as 3 days after mifepristone. Medical abortion service delivery with an MLPT to obtain a baseline (preabortion) human chorionic gonadotropin (hCG) estimate and a second follow-up MLPT 1 to 2 weeks later can establish whether there has been a drop in hCG, signifying absence of a continuing pregnancy. Used this way, MLPTs can enable women to assess their abortion status outside of a clinic setting and without serum h
Hensel, Mario; Schmidbauer, Willi; Benker, Michael; Schmieder, Paula; Kerner, Thoralf
The use of supraglottic airways has been recommended in combat trauma airway management. To ensure an adequate airway management on the battlefield, suitable training concepts are sought to efficiently teach as many soldiers as possible. Our aim was to compare three approaches of teaching laypersons in the handling of supraglottic airways in a mannequin model. In this prospective randomized blinded study, 285 military service men without any medical background were divided into three groups and trained in the use of the Laryngeal Mask Airway Supreme (LMA) and the Laryngeal Tube Disposable (LT-D). The first group received a theoretical lecture, the second group was shown an instruction video, and the third group underwent a practical training. Immediately after instruction participants were asked to place the supraglottic airway and ventilate the mannequin within 60 seconds. The entire test was repeated 3 months later. Test results were evaluated with regard to success rate, insertion time, ability to judge the correct placement, and degree of difficulty. Practical training showed the highest success rate when placing supraglottic airways immediately after the instruction (lecture: 68%, video: 74%, training: 94%); (training vs. lecture and training vs. video, p instruction practical training was also superior in terms of insertion time, ability to judge the correct placement, and the self-rated degree of difficulty (p instruction. In comparison between supraglottic airways LT-D was superior to LMA regarding all the outcome parameters mentioned above (p following minimal instruction and after 3 months as well. Study participants achieved the best results after practical training followed by video presentation and finally lecture regardless of the airway device used. There are two possible reasons why practical training is the superior method. Firstly, the success is tied to more time spent with the learners. Secondly, practical training seems to be the best teaching
Kono, Ayumi; Izumi, Kyoko; Yoshiyuki, Noriko; Kanaya, Yukiko; Rubenstein, Laurence Z
The aim of this randomized controlled trial was to determine the effects on functional parameters of an updated preventive home visit program for frail older adults in the Japanese Long-term Care Insurance (LTCI) system. The program included home visits by nurses or care managers every 3 months for 24 months, with a systematic assessment of care needs to prevent functional decline. Eligible participants (N = 360) were randomly assigned to the visit (VG: n = 179) or control group (CG: n = 181). Functional parameters were gathered via mail questionnaires at baseline and at 12- and 24-month follow-ups. Care-need levels in the LTCI were obtained at 12-, 24-, and 36-month follow-ups and the utilization of the LTCI service through 36 months. Participants in VG were significantly more likely to maintain their activities of daily living (ADL) functioning (p = .0113) and less likely to increase care-needs level, compared with CG participants, over 24 months. A generalized linear model showed that the estimate of the effect on increase in care-needs level (ie, functional decline) was -0.53 (p = .042) over 36 months. These results suggest that the updated preventive home visit program could be effective for the prevention of ADL and care-needs deterioration, and these effects could continue up to 1 year after program completion. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: firstname.lastname@example.org.
Full Text Available BACKGROUND/OBJECTIVES: Pain-related misbeliefs among health care professionals (HCPs are common and contribute to ineffective postoperative pain assessment. While standardized patients (SPs have been effectively used to improve HCPs’ assessment skills, not all centres have SP programs. The present equivalence randomized controlled pilot trial examined the efficacy of an alternative simulation method – deteriorating patient-based simulation (DPS – versus SPs for improving HCPs’ pain knowledge and assessment skills.
da Mota Menezes, Valfredo; Atallah, Alvaro Nagib; Lapa, Antonio José; Catapani, Wilson R
The eradication of Helicobacter pylori is easily achieved by combining antisecretory agents and antibiotics; however, the cost of these associations is very high for the population of Third World countries, where the prevalence of the infection is even higher and leads to markedly reduced treatment effectiveness. We tested a plant (Lafoensia pacari) that is used in the central region of Brazil. According to previous studies, this plant has high concentrations of ellagic acid, which presents gastric antisecretory and antibacterial actions. One hundred dyspeptic, urease-positive patients were randomized to receive 500 mg of methanolic extract of L. pacari (n = 55) or placebo (n = 45), for 14 days, in a double-blind clinical trial. The main variables assessed were the eradication of H. pylori 8 weeks after the intervention and complete symptom relief at the end of the treatment. The examinations (urease and histology) showed persistence of H. pylori in 100% of participants. Complete symptom relief was experienced by 42.5% of patients (95% CI: 29.4-55.8) in the intervention group and by 21% (95% CI: 8.8-33.1) in the control group, p = .020. The side-effects were minimal and similar in both groups. The extract of L. pacari as a single agent was not effective to eradicate H. pylori. However, it was well tolerated and many participants reported relief of symptoms. Future studies may test the agent using larger doses and longer periods, in monotherapy or in combination with antibiotics.
Creech, C Buddy; Dekker, Cornelia L; Ho, Dora; Phillips, Shanda; Mackey, Sally; Murray-Krezan, Cristina; Grazia Pau, Maria; Hendriks, Jenny; Brown, Valerie; Dally, Leonard G; Versteege, Isabella; Edwards, Kathryn M
Malaria results in over 650,000 deaths each year; thus, there is an urgent need for an effective vaccine. Pre-clinical studies and recently reported human trials suggest that pre-erythrocytic stage vaccines can provide protection against infection. A Phase 1, randomized, placebo-controlled, dose-escalation study was conducted with a vaccine composed of a replication-deficient adenovirus-35 backbone with P. falciparum circumsporozoite (CS) surface antigen (Ad35.CS.01). Healthy adult subjects received three doses of 10 (8), 10 (9), 10 (10), or 10 (11) vp/mL Ad35.CS.01 vaccine or saline placebo intramuscularly at 0, 1, and 6-mo intervals. Adverse events were assessed and anti-CS antibody responses were determined by ELISA. Seventy-two individuals were enrolled, with age, gender, and ethnicity similar across each study arm. While the vaccine was generally well tolerated, adverse events were more frequent in the highest dose groups (10 (10) and 10 (11) vp/mL). More robust humoral responses were also noted at the highest doses, with 73% developing a positive ELISA response after the three dose series of 10 (11) vp/mL. The Ad35.CS.01 vaccine was most immunogenic at the highest dosages (10 (10) and 10 (11) vp/mL). Reactogenicity findings were more common after the 10 (11) vp/mL dose, although most were mild or moderate in nature and resolved without therapy.
Full Text Available The present study describes the development of a comprehensive quality of reporting assessment tool and its application to acupuncture RCTs from 1997–2007. This Oregon CONSORT STRICTA Instrument (OCSI is based on the revised CONSORT guidelines as modified by the STRICTA recommendations for acupuncture trials. Each of the resulting 27 OCSI items were applied to English language prospective RCTs that compared acupuncture, using manual and/or electro-stimulation, to no treatment, a sham procedure, or usual biomedical care. The 333 RCTs that met inclusion criteria were dispersed among 27 countries and 141 journals. Mean quality of reporting score for all articles was 63.0% (SD 16.5. Mean OCSI scores revealed a 30.9% improvement over the ten-year period (P<.001. Our findings suggest that to enhance quality of reporting, authors should better attend to seven specific OCSI items in three categories: practitioner training, adverse events, and aspects of randomization and blinding (n=5. The broad diversity in geographical origin, publication site and quality of reporting, viewed in light of the considerable room for improvement in mean OCSI scores, emphasizes the importance of making STRICTA as well as CONSORT more widely known to journals and to the acupuncture research community.
Full Text Available The purpose of this study is to assess the beneficial effects of a far-infrared-emitting collar (FIRC on the management of neck disorders. A neck disorder is generalized as neck muscle pain and its relative mental disorders because the etiologies of the neck’s multidimensional syndrome are either muscle impairment or psychiatric distress. This is the first study to determine the efficacy of a FIRC by evaluating objective physical evidence and psychometric self-reports using a parallel-arm randomized sham-controlled and single-blinded design. In this trial, 60 participants with neck disorders were observed at baseline and post-intervention. Compared to the placebo group after a 30-min intervention, the FIRC demonstrated a statistically significant biological effect in elevating skin temperature and promoting blood circulation with p-values 0.003 and 0.020, respectively. In addition, FIRC application significantly reduced neck muscle tension, relieved pain, ameliorated fatigue, improved depression, and decreased anxiety. The FIRC could therefore be a potential treatment for neck disorders.
Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial).
Labhardt, Niklaus Daniel; Ringera, Isaac; Lejone, Thabo Ishmael; Masethothi, Phofu; Thaanyane, T'sepang; Kamele, Mashaete; Gupta, Ravi Shankar; Thin, Kyaw; Cerutti, Bernard; Klimkait, Thomas; Fritz, Christiane; Glass, Tracy Renée
Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART) in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation. This two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test). The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms. This trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow-up visits at the clinic could be a pragmatic approach to
Full Text Available Abstract Background Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2, however, its clinical efficacies on oral malodor have been evaluated only with organoleptic measurements (OM or sulphide monitors. No clinical studies have investigated the inhibitory effects of ClO2 on volatile sulfur compounds (VSCs using gas chromatography (GC. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor using OM and GC. Methods A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups. In the first test phase, the group 1 subjects (N = 8 were instructed to rinse with the experimental mouthwash containing ClO2, and those in group 2 (N = 7 to rinse with the placebo mouthwash without ClO2. In the second test, phase after a one week washout period, each group used the opposite mouthwash. Oral malodor was evaluated before rinsing, right after rinsing and every 30 minutes up to 4 hours with OM, and concentrations of hydrogen sulfide (H2S, methyl mercaptan (CH3SH and dimethyl sulfide ((CH32S, the main VSCs of human oral malodor, were evaluated with GC. Results The baseline oral condition in the subjects in the 2 groups did not differ significantly. The mouthwash containing ClO2 improved morning bad breath according to OM and reduced concentrations of H2S, CH3SH and (CH32S according to GC up to 4 hours after rinsing. OM scores with ClO2 were significantly lower than those without ClO2 at all examination times. Significant reductions in the concentrations of the three kinds of VSCs measured by GC were also evident at all examination times. The concentrations of the three gases with ClO2 were significantly lower than those without ClO2 at most examination times. Conclusion In this explorative study, ClO2 mouthwash was effective at reducing morning malodor for 4
Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Rinke de Wit, Tobias F
Health worker density per 1000 population in Ghana is one of the lowest in the world estimated to be 2.3, below the global average of 9.3. Low health worker motivation induced by poor working conditions partly explain this challenge. Albeit the wage bill for public sector health workers is about 90% of domestic government expenditure on health in countries such as Ghana, staff motivation and performance output remain a challenge, suggesting the need to complement financial incentives with non-financial incentives through a community-based approach. In this study, a systematic community engagement (SCE) intervention was implemented to engage community groups in healthcare quality assessment to promote mutual collaboration between clients and healthcare providers, and enhance health worker motivation levels. SCE involves structured use of existing community groups and associations to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements made and rewards given to best performing facilities for closing quality care gaps. To evaluate the effect of SCE interventions on health worker motivation and experiences with clients. The study is a cluster randomized trial involving health workers in private (n = 38) and public (n = 26) primary healthcare facilities in two administrative regions in Ghana. Out of 324 clinical and non-clinical staff randomly interviewed at baseline, 234 (72%) were successfully followed at end-line and interviewed on workplace motivation factors and personal experiences with clients. Propensity score matching and difference-in-difference estimations were used to estimate treatment effect of the interventions on staff motivation. Intrinsic (non-financial) work incentives including cordiality with clients and perceived career prospects appeared to be prime sources of motivation for health staff interviewed in intervention health facilities while financial incentives were ranked
Robert Kaba Alhassan
Full Text Available Health worker density per 1000 population in Ghana is one of the lowest in the world estimated to be 2.3, below the global average of 9.3. Low health worker motivation induced by poor working conditions partly explain this challenge. Albeit the wage bill for public sector health workers is about 90% of domestic government expenditure on health in countries such as Ghana, staff motivation and performance output remain a challenge, suggesting the need to complement financial incentives with non-financial incentives through a community-based approach. In this study, a systematic community engagement (SCE intervention was implemented to engage community groups in healthcare quality assessment to promote mutual collaboration between clients and healthcare providers, and enhance health worker motivation levels. SCE involves structured use of existing community groups and associations to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements made and rewards given to best performing facilities for closing quality care gaps.To evaluate the effect of SCE interventions on health worker motivation and experiences with clients.The study is a cluster randomized trial involving health workers in private (n = 38 and public (n = 26 primary healthcare facilities in two administrative regions in Ghana. Out of 324 clinical and non-clinical staff randomly interviewed at baseline, 234 (72% were successfully followed at end-line and interviewed on workplace motivation factors and personal experiences with clients. Propensity score matching and difference-in-difference estimations were used to estimate treatment effect of the interventions on staff motivation.Intrinsic (non-financial work incentives including cordiality with clients and perceived career prospects appeared to be prime sources of motivation for health staff interviewed in intervention health facilities while financial incentives were
Schwingshackl, Lukas; Knüppel, Sven; Schwedhelm, Carolina; Hoffmann, Georg; Missbach, Benjamin; Stelmach-Mardas, Marta; Dietrich, Stefan; Eichelmann, Fabian; Kontopantelis, Evangelos; Iqbal, Khalid; Aleksandrova, Krasimira; Lorkowski, Stefan; Leitzmann, Michael F; Kroke, Anja; Boeing, Heiner
The objective of this study was to develop a scoring system (NutriGrade) to evaluate the quality of evidence of randomized controlled trial (RCT) and cohort study meta-analyses in nutrition research, building upon previous tools and expert recommendations. NutriGrade aims to assess the meta-evidence of an association or effect between different nutrition factors and outcomes, taking into account nutrition research-specific requirements not considered by other tools. In a pretest study, 6 randomly selected meta-analyses investigating diet-disease relations were evaluated with NutriGrade by 5 independent raters. After revision, NutriGrade was applied by the same raters to 30 randomly selected meta-analyses in the same thematic area. The reliability of ratings of NutriGrade items was calculated with the use of a multirater κ, and reliability of the total (summed scores) was calculated with the use of intraclass correlation coefficients (ICCs). The following categories for meta-evidence evaluation were established: high (8-10), moderate (6-7.99), low (4-5.99), and very low (0-3.99). The NutriGrade scoring system (maximum of 10 points) comprises the following items: 1) risk of bias, study quality, and study limitations, 2) precision, 3) heterogeneity, 4) directness, 5) publication bias, 6) funding bias, 7) study design, 8) effect size, and 9) dose-response. The NutriGrade score varied between 2.9 (very low meta-evidence) and 8.8 (high meta-evidence) for meta-analyses of RCTs, and it ranged between 3.1 and 8.8 for meta-analyses of cohort studies. The κ value of the ratings for each scoring item varied from 0.32 (95% CI: 0.22, 0.42) for risk of bias for cohort studies and 0.95 (95% CI: 0.91, 0.99) for study design, with a mean κ of 0.66 (95% CI: 0.53, 0.79). The ICC of the total score was 0.81 (95% CI: 0.69, 0.90). The NutriGrade scoring system showed good agreement and reliability. The initial findings regarding the performance of this newly established scoring system
Knüppel, Sven; Schwedhelm, Carolina; Hoffmann, Georg; Missbach, Benjamin; Stelmach-Mardas, Marta; Dietrich, Stefan; Eichelmann, Fabian; Kontopanteils, Evangelos; Iqbal, Khalid; Aleksandrova, Krasimira; Lorkowski, Stefan; Leitzmann, Michael F; Kroke, Anja; Boeing, Heiner
The objective of this study was to develop a scoring system (NutriGrade) to evaluate the quality of evidence of randomized controlled trial (RCT) and cohort study meta-analyses in nutrition research, building upon previous tools and expert recommendations. NutriGrade aims to assess the meta-evidence of an association or effect between different nutrition factors and outcomes, taking into account nutrition research–specific requirements not considered by other tools. In a pretest study, 6 randomly selected meta-analyses investigating diet–disease relations were evaluated with NutriGrade by 5 independent raters. After revision, NutriGrade was applied by the same raters to 30 randomly selected meta-analyses in the same thematic area. The reliability of ratings of NutriGrade items was calculated with the use of a multirater κ, and reliability of the total (summed scores) was calculated with the use of intraclass correlation coefficients (ICCs). The following categories for meta-evidence evaluation were established: high (8–10), moderate (6–7.99), low (4–5.99), and very low (0–3.99). The NutriGrade scoring system (maximum of 10 points) comprises the following items: 1) risk of bias, study quality, and study limitations, 2) precision, 3) heterogeneity, 4) directness, 5) publication bias, 6) funding bias, 7) study design, 8) effect size, and 9) dose-response. The NutriGrade score varied between 2.9 (very low meta-evidence) and 8.8 (high meta-evidence) for meta-analyses of RCTs, and it ranged between 3.1 and 8.8 for meta-analyses of cohort studies. The κ value of the ratings for each scoring item varied from 0.32 (95% CI: 0.22, 0.42) for risk of bias for cohort studies and 0.95 (95% CI: 0.91, 0.99) for study design, with a mean κ of 0.66 (95% CI: 0.53, 0.79). The ICC of the total score was 0.81 (95% CI: 0.69, 0.90). The NutriGrade scoring system showed good agreement and reliability. The initial findings regarding the performance of this newly established
Martínez Vizcaíno, V; Salcedo Aguilar, F; Franquelo Gutiérrez, R; Solera Martínez, M; Sánchez López, M; Serrano Martínez, S; López García, E; Rodríguez Artalejo, F
To assess the impact of a physical activity program on obesity in primary school children. Cluster-randomized controlled trial with 10 intervention and 10 control schools. A total of 1044 children, mean age 9.4 years (s.d.=0.7) at baseline, of the Province of Cuenca, Spain. Recreational, non-competitive physical activity program conducted after school hours on school premises. The program consisted of three 90-min sessions per week, for 24 weeks. Body mass index (BMI), triceps skin-fold thickness (TST) and percentage body fat. Secondary measures were blood lipids and blood pressure. Measurements were made at the beginning (September 2004) and at the end of the program (June 2005). Since schools rather than children were randomized, mixed regression models were used to adjust for individual-level covariates under cluster randomization. There were no differences in BMI between the intervention and control groups. Compared with controls, intervention children showed a decrease in TST in both boys (-1.14 mm; 95% confidence interval (CI) -1.71 to -057; P<0.001) and girls (-1.55 mm; 95% CI -2.38 to -0.73; P<0.001), as well as a reduction in the percentage of body fat in girls (-0.58%; 95% CI -1.04 to -0.11; P=0.02). Furthermore, the intervention boys exhibited a decrease in apolipoprotein (apo) B levels (-4.59; 95% CI -8.81 to -0.37; P=0.03) and an increase in apo A-I levels (13.57; 95% CI 7.95-19.20; P<0.001). Blood lipid results in girls were very similar. No changes in total cholesterol, triglycerides or blood pressure were associated with the intervention in either sex, except for an increase in diastolic blood pressure (1.55 mm Hg; 95% CI 0.19-2.91; P=0.03) in the intervention versus control boys. An after-school program of recreational physical activity reduced adiposity, increased apo A-I and decreased apo B in primary school children.
Kerns, Michelle L.; Guss, Lark; Fahey, Jed; Cohen, Bernard; Hakim, Jill M. C.; Sung, Sarah; Lu, Rosemary G.; Coulombe, Pierre A.
Background Epidermolysis bullosa simplex is a skin-blistering disorder caused by mutations in keratin (K)14 or K5. Treatment with nuclear factor (erythroid-derived 2)-like 2 inducer sulforaphane ameliorated skin blistering in Krt14-null mice, correlating with induction of K17. To be therapeutically useful for epidermolysis bullosa simplex, topical broccoli sprout extract (BSE), enriched for sulforaphane, would ideally induce the expression of homologous keratins (eg, K6, K17, K16) in the basal layer of human epidermis without impacting expression of defective keratins (K5/K14). Objective The purpose of this 1-week, randomized, split-body, single-blinded, placebo-controlled trial was to assess the impact of BSE on keratin expression. Methods Five subjects (34–71 years old) applied BSE (500 nmol of sulforaphane/mL) or vehicle alone to the inner aspect of the arm daily. Expression of keratin, nuclear factor (erythroid-derived 2)-like 2, and other markers was assessed using reverse transcription-polymerase chain reaction and indirect immunofluorescence. Results One subject (age 71 years) was excluded a posteriori because of poor tissue quality. Topical BSE activated nuclear factor (erythroid-derived 2)-like 2 and up-regulated K17 in the epidermis of all subjects, had variable effects on K16 and K6 expression, and did not alter expression of K14 or K5. Limitations Small sample size is a limitation. Conclusion BSE represents an attractive therapeutic candidate for K14-associated epidermolysis bullosa simplex. PMID:27889290
Hölscher, Birgit; Heitmeyer, Christine; Fobker, Manfred; Breithardt, Günter; Schaefer, Roland M; Reinecke, Holger
BACKGROUND: Among the numerous studies concerning contrast media-induced nephropathy (CIN), there was no prospective trial that provided data on the long-term outcomes. OBJECTIVES: To prospectively assess predictors of CIN and long-term outcomes of affected patients. METHODS: Four hundred twelve consecutive patients with serum creatinine levels of 115 μmol/L to 309 μmol/L (1.3 mg/dL to 3.5 mg/dL) undergoing elective coronary angiography were included. Patients were randomly assigned to periprocedural hydration alone, hydration plus onetime hemodialysis or hydration plus N-acetylcysteine. RESULTS: Multivariate logistic regression identified the following as predictors of CIN within 72 h (equivalent to an increase in creatinine 44.2 μmol/L [0.5 mg/dL] or more) : prophylactic postprocedural hemodialysis (OR 2.86, 95% CI 1.07 to 7.69), use of angiotensin-converting enzyme inhibitors (OR 6.16, 95% CI 2.01 to 18.93), baseline glomerular filtration rate (OR 0.94, 95% CI 0.90 to 0.98) and the amount of contrast media given (OR 1.01, 95% CI 1.00 to 1.01). With regard to long-term outcome (mean follow-up 649 days), multivariate Cox regression models found elevated creatinine levels at 30 days (hazard rate ratio [HRR] 5.48, 95% CI 2.85 to 10.53), but not CIN within 72 h (HRR 1.12, 95% CI 0.63 to 2.02), to be associated with increased mortality. In addition, independent predictors for death during follow-up included left ventricular ejection fraction lower than 35% (HRR 4.01, 95% CI 2.22 to 7.26), serum phosphate (HRR 1.64, 95% CI 1.10 to 2.43) and hemoglobin (HRR 0.80, 95% CI 0.67 to 0.96). CONCLUSION: From the present prospective trial, performance of post-procedural hemodialysis, use of angiotensin-converting enzyme inhibitors, reduced baseline glomerular filtration rate and amount of contrast media were independent predictors of CIN within 72 h after catheterization. Assessing renal function after 30 days, rather than within 72 h, seemed to be more predictive for
Jack, Darby W.; Asante, Kwaku Poku; Blair J. Wylie; Chillrud, Steve N.; Whyatt, Robin M.; Ae-Ngibise, Kenneth A.; Quinn, Ashlinn K.; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth
Background: Household air pollution exposure is a major health risk, but validated interventions remain elusive. Methods/Design The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed seve...
Hróbjartsson, A; Boutron, I
Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...... and empirical analyses support the blinding of patients, health-care providers, and outcome assessors as to the trial intervention to which patients have been allocated. We encourage extensive pretrial testing of blinding procedures and explicit reporting of who was in the blinded condition and the methods used...
Quimby, Jessica M; Webb, Tracy L; Randall, Elissa; Marolf, Angela; Valdes-Martinez, Alex; Dow, Steve W
Feline chronic kidney disease (CKD) is characterized by chronic tubulointerstitial nephritis, and inflammation contributes to the progression of renal fibrosis. Mesenchymal stem cells (MSCs) have demonstrated anti-inflammatory and antifibrotic effects in rodent CKD models. However, few randomized trials evaluating the effectiveness of MSC therapy for diseases in companion animals have been reported. The purpose of this study was to evaluate the effectiveness of allogeneic MSCs for the treatment of feline CKD using a randomized, placebo-controlled trial. MSCs were isolated from the cryopreserved adipose tissues of specific pathogen-free research cats and culture expanded. CKD cats were enrolled in a randomized, placebo-controlled, blinded one-way crossover clinical study. Four CKD cats were randomized to receive 2 × 10(6) MSCs/kg intravenously at 2, 4 and 6 weeks. Four CKD cats were randomized to receive placebo, with two cats crossing over to the MSC treatment group and one cat failing to complete the trial. Complete blood counts, chemistry and urinalysis were performed at weeks 0, 2, 4, 6 and 8. Glomerular filtration rate (GFR) via nuclear scintigraphy and urine protein:creatinine ratio (UPC) were determined at weeks 0 and 8. Six cats received three doses of allogeneic MSC culture expanded from cryopreserved adipose without adverse effects. No significant change in serum creatinine, blood urea nitrogen, potassium, phosphorus, GFR by nuclear scintigraphy, UPC or packed cell volume was seen in cats treated with MSCs. Individual changes in GFR were 12%, 8%, 8%, 2%, -13% and -67% in treated cats compared with 16%, 36% and 0% in placebo-treated cats. While administration of MSC culture expanded from cryopreserved adipose was not associated with adverse effects, significant improvement in renal function was not observed immediately after administration. Long-term follow-up is necessary to determine whether MSC administration affects disease progression in cats with CKD
Assessing vaccine efficacy for the prevention of acute otitis media by pneumococcal vaccination in children: a methodological overview of statistical practice in randomized controlled clinical trials.
Jahn-Eimermacher, Antje; du Prel, Jean-Baptist; Schmitt, Heinz-Josef
Acute otitis media (AOM) is the most common bacterial infectious disease among children. Vaccination is proposed to prevent otitis and several clinical trials were performed to assess the efficacy of pneumococcal vaccines. The way vaccine efficacy is analysed varies among trials. However, the clinical meaning of an estimate of vaccine effect and its statistical test depends on the applied statistical method. We aim to bring the meaning and validity of statistical trial results to the attention of researchers. We consider all methodological approaches for analysing vaccine efficacy applied in pneumococcal vaccination trials included in a recent Cochrane Review. We demonstrate how different methods address different scientific questions on the effect of vaccination, how they can complement each other and why some methods can produce misleading results.
Bianchi, Giorgia; Salvadé, Vanja; Lucchini, Barbara; Schätti-Stählin, Sibylle; Salvadé, Igor; Burnier, Michel; Gabutti, Luca
Clinical experience and experimental data suggest that intradialytic hemodynamic profiles could be influenced by the characteristics of the dialysis membranes. Even within the worldwide used polysulfone family, intolerance to specific membranes was occasionally evoked. The aim of this study was to compare hemodynamically some of the commonly used polysulfone dialyzers in Switzerland. We performed an open-label, randomized, cross-over trial, including 25 hemodialysis patients. Four polysulfone dialyzers, A (Revaclear high-flux, Gambro, Stockholm, Sweden), B (Helixone high-flux, Fresenius), C (Xevonta high-flux, BBraun, Melsungen, Germany), and D (Helixone low-flux, Fresenius, Bad Homburg vor der Höhe, Germany), were compared. The hemodynamic profile was assessed and patients were asked to provide tolerance feedback. The mean score (±SD) subjectively assigned to dialysis quality on a 1-10 scale was A 8.4 ± 1.3, B 8.6 ± 1.3, C 8.5 ± 1.6, D 8.5 ± 1.5. Kt/V was A 1.58 ± 0.30, B 1.67 ± 0.33, C 1.62 ± 0.32, D 1.45 ± 0.31. The low- compared with the high-flux membranes, correlated to higher systolic (128.1 ± 13.1 vs. 125.6 ± 12.1 mmHg, P 20 mmHg) were 70 with A, 87 with B, 73 with C, and 75 with D (P Hemodialysis.
Rombauts, Luk; Healy, David; Norman, Rob J
This randomized controlled trial was designed to assess the impact of oral contraceptive (OC) scheduling with a GnRH antagonist (ganirelix) regimen on the ovarian response of women undergoing recombinant FSH (rFSH) stimulation for IVF, compared with a non-scheduled ganirelix regimen and a long GnRH agonist (nafarelin) protocol. A total of 110 women was treated with an OC and ganirelix, 111 with ganirelix alone and 111 with nafarelin. The OC (containing 30 microg ethinylestradiol/150 microg desogestrel) was taken for 14-28 days and stopped 2 days prior to the start of rFSH treatment. Primary efficiency parameters were the number of cumulus-oocyte complexes (per attempt) and the number of grade 1 or 2 embryos (per attempt). In terms of follicular growth and hormone profiles, the OC-scheduled antagonist regimen mimicked the agonist regimen rather than the (non-scheduled) GnRH antagonist regimen. In the OC-scheduled GnRH antagonist group and the nafarelin group (versus the non-scheduled antagonist group), pituitary suppression was more profound at the start of stimulation (P growth (P < or = 0.001), longer stimulation was required (11.7 and 10.3 days respectively versus 9.4; P < or = 0.001), and more rFSH was used (2667 and 2222 IU versus 1966 IU; P < or = 0.001). In the three groups, the number of oocytes was similar (13.1, 12.9 and 11.5 respectively; not significant) as well as the number of good quality embryos (5.1, 5.7 and 5.0 respectively; not significant). OC treatment prior to the rFSH/ganirelix regimen can be successfully applied to schedule patients, although more days of stimulation and more rFSH are required than with a non-scheduled GnRH antagonist regimen.
Toledo, Estefanía; Hu, F. B.; Estruch Riba, Ramon; Buil-Cosiales, P.; Corella Piquer, Dolores; Salas Salvadó, Jordi; Covas Planells, María Isabel; Arós, Fernando; Gómez-Gracia, E.; Fiol Sala, Miguel; Lapetra, José; Serra Majem, Lluís; Pintó Sala, Xavier; Lamuela Raventós, Rosa Ma.; Sáez Tormo, Guillermo
BACKGROUND: Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern. METHODS: The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for car...
Wolthers, Ole D; Stone, Sally; Bareille, Philippe; Tomkins, Susan; Khindri, Sanjeev
A dry powder inhaler formulation of the inhaled corticosteroid fluticasone furoate (FF) is being evaluated for use in children. An important potential risk associated with the use of inhaled corticosteroids in children is growth suppression. Therefore, the aim of this study was to assess the short-term lower leg growth in children with asthma treated for 2 weeks with inhaled FF versus placebo from the ELLIPTA inhaler. Prepubertal children with persistent asthma (n = 60; aged 5 to <12 years) were recruited into a randomized, double-blind, placebo-controlled, 2-way crossover, noninferiority study. The study consisted of four 2-week periods: run-in, 2 treatment periods, 1 washout period, and a 1-week follow-up period. Interventions were FF 50 µg and placebo once daily in the evening. Lower leg length was measured by using knemometry. The randomized ITT population comprised 36 boys and 24 girls with a mean age of 8.7 (standard deviation, 1.5; range, 5-11) years; 58% had a duration of asthma ≥5 years. Fifty-eight subjects completed both treatment periods. The least squares mean growth rate was 0.31 mm/week during treatment with FF and 0.36 mm/week during the placebo period. The difference in adjusted least squares mean growth rates between FF and placebo was -0.052 mm/week with a 95% CI of -0.122 to 0.018. This finding was greater than the prespecified noninferiority margin of -0.20 mm/week. The overall incidence of adverse events was 35% with placebo and 22% with FF. Inhaled FF 50 µg provided once daily for 2 weeks was noninferior to placebo in terms of effects on short-term lower leg growth in children with asthma. To further quantify the risk of growth suppression in children, intermediate-term growth studies should be conducted. Inhaled FF 50 µg was well tolerated in this study population. ClinicalTrials.gov identifier: NCT02502734. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Gums, Tyler; Carter, Barry; Foster, Eric
Introduction Cluster randomized trials (CRTs) are now the gold standard in health services research, including pharmacy-based interventions. Studies of behaviour, epidemiology, lifestyle modifications, educational programs, and health care models are utilizing the strengths of cluster randomized analyses. Methodology The key property of CRTs is the unit of randomization (clusters), which may be different from the unit of analysis (individual). Subject sample size and, ideally, the number of clusters is determined by the relationship of between-cluster and within-cluster variability. The correlation among participants recruited from the same cluster is known as the intraclass correlation coefficient (ICC). Generally, having more clusters with smaller ICC values will lead to smaller sample sizes. When selecting clusters, stratification before randomization may be useful in decreasing imbalances between study arms. Participant recruitment methods can differ from other types of randomized trials, as blinding a behavioural intervention cannot always be done. When to use CRTs can yield results that are relevant for making "real world" decisions. CRTs are often used in non-therapeutic intervention studies (e.g. change in practice guidelines). The advantages of CRT design in pharmacy research have been avoiding contamination and the generalizability of the results. A large CRT that studied physician-pharmacist collaborative management of hypertension is used in this manuscript as a CRT example. The trial, entitled Collaboration Among Pharmacists and physicians To Improve Outcomes Now (CAPTION), was implemented in primary care offices in the United States for hypertensive patients. Limitations CRT design limitations include the need for a large number of clusters, high costs, increased training, increased monitoring, and statistical complexity.
Abbas Makarem; Navid Ravandeh; Masoumeh Ebrahimi
Background and aims. The superiority of rotary systems has been reported in several clinical studies on permanent teeth. This study consisted of radiographic assessment and chair time of rotary instruments in the pulpectomy of primary second molar teeth. Materials and methods. In this randomized controlled clinical study, 46 children, 3-6 years of age, were selected. The patients were divided randomly into two groups. In the first group (group A) pulpectomy was carried out with ha...
Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63
Bartoli, E; Sorrentino, D; Trevisi, A
Randomized clinical trials represent the final, essential link between basic medical research and human health. However, their conduction presents very complex ethical problems, since the patient is the actual target of the experiment. Proper randomization, informed consent, and preliminary disclosure of results create deep ethical conflicts between the role of caretaker and that of impartial observer, both played by the same doctor. The dilemma reproduces the conflict between two different ethics. One is based on the inalienable individual rights stemming from the concept of man as an end in himself and not a means to an end. The other, derived from utilitarian philosophies, is based on the benefit for society as a whole. If we agree that randomized clinical trials represent the best method to test the validity of a new treatment, there is no easy solution. The dilemma could be solved by separating the role of the family doctor, committed to the best treatment possible for his patient, from the role of the scientist, committed to the progress of science and humanity. The former is involved in the treatment of individual patients, the latter in clinical and scientific experiments of a therapeutic nature. The patient may trade his rights to the best possible cure for the safety and the efficiency guaranteed by the scientific institution conducting the trial. Trials on relevant issues--expected to produce important results and impeccably designed scientifically--could be endowed with the ethics of science per se and this could be considered equivalent to the individual rights waived by the patient.
A randomized phase 3 trial of thalidomide and prednisone as maintenance therapy after ASCT in patients with MM with a quality-of-life assessment: the National Cancer Institute of Canada Clinicals Trials Group Myeloma 10 Trial
Trudel, Suzanne; Bahlis, Nizar J.; White, Darrell; Sabry, Waleed; Belch, Andrew; Reiman, Tony; Roy, Jean; Shustik, Chaim; Kovacs, Michael J.; Rubinger, Morel; Cantin, Guy; Song, Kevin; Tompkins, Kirsty A.; Marcellus, Deb C.; Lacy, Martha Q.; Sussman, Jonathan; Reece, Donna; Brundage, Michael; Harnett, Erica L.; Shepherd, Lois; Chapman, Judy-Anne W.; Meyer, Ralph M.
We conducted a randomized, controlled trial comparing thalidomide-prednisone as maintenance therapy with observation in 332 patients who had undergone autologous stem cell transplantation with melphalan 200 mg/m2. The primary end point was overall survival (OS); secondary end points were myeloma-specific progression-free survival, progression-free survival, incidence of venous thromboembolism, and health-related quality of life (HRQoL). With a median follow-up of 4.1 years, no differences in OS between thalidomide-prednisone and observation were detected (respective 4-year estimates of 68% vs 60%, respectively; hazard ratio = 0.77; P = .18); thalidomide-prednisone was associated with superior myeloma-specific progression-free survival and progression-free survival (for both outcomes, the 4-year estimates were 32% vs 14%; hazard ratio = 0.56; P thalidomide-prednisone and 34.1 months in the observation group. Nine second malignancies were observed with thalidomide-prednisone versus 6 in the observation group. Those allocated to thalidomide-prednisone reported worse HRQoL with respect to cognitive function, dyspnea, constipation, thirst, leg swelling, numbness, dry mouth, and balance problems. We conclude that maintenance therapy with thalidomide-prednisone after autologous stem cell transplantation improves the duration of disease control, but is associated with worsening of patient-reported HRQoL and no detectable OS benefit. PMID:23297129
Pinto, Rafael Zambelli; Elkins, Mark R; Moseley, Anne M; Sherrington, Catherine; Herbert, Robert D; Maher, Christopher G; Ferreira, Paulo H; Ferreira, Manuela L
Clinical trial registration has several putative benefits: prevention of selective reporting, avoidance of duplication, encouragement of participation, and facilitation of reviews. Previous surveys suggest that most trials are registered. However, these surveys examined only trials in journals with high impact factors, which may bias the results. This study examined the completeness of clinical trial registration and the extent of selective reporting of outcomes in a random sample of published randomized trials in physical therapy. This was a retrospective cohort study in which 200 randomized trials of physical therapy interventions were randomly selected from those published in 2009 and indexed in the Physiotherapy Evidence Database (PEDro), regardless of the publishing journal. Evidence of registration was sought for each trial in the study, on clinical trial registers, and by contacting authors. The proportion of randomized trials that were registered was 67/200 (34%). This proportion was significantly lower than among the trials in journals with high impact factors, where the proportion was 75% (odds ratio=7.4, 95% confidence interval=2.6-21.4). Unambiguous primary outcomes (ie, method and time points of measurement clearly defined in the trial registry entry) were registered for 32 trials, and registration was adequate (ie, prospective with unambiguous primary outcomes) for 5/200 (2.5%) trials. Selective outcome reporting occurred in 23 (47%) of the 49 trials in which selective reporting was assessable. The inclusion of only English-language trials prevents generalization of the results to non-English-language trials. Registration of randomized trials of physical therapy interventions is rarely adequate. Consequently, the putative benefits of registration are not being fully realized.
A systematic review of outcomes assessed in randomized controlled trials of surgical interventions for carpal tunnel syndrome using the International Classification of Functioning, Disability and Health (ICF as a reference tool
Full Text Available Abstract Background A wide range of outcomes have been assessed in trials of interventions for carpal tunnel syndrome (CTS, however there appears to be little consensus on what constitutes the most relevant outcomes. The purpose of this systematic review was to identify the outcomes assessed in randomized clinical trials of surgical interventions for CTS and to compare these to the concepts contained in the International Classification of Functioning, Disability and Health (ICF. Methods The bibliographic databases Medline, AMED and CINAHL were searched for randomized controlled trials of surgical treatment for CTS. The outcomes assessed in these trials were identified, classified and linked to the different domains of the ICF. Results Twenty-eight studies were retrieved which met the inclusion criteria. The most frequently assessed outcomes were self-reported symptom resolution, grip or pinch strength and return to work. The majority of outcome measures employed assessed impairment of body function and body structure and a small number of studies used measures of activity and participation. Conclusion The ICF provides a useful framework for identifying the concepts contained in outcome measures employed to date in trials of surgical intervention for CTS and may help in the selection of the most appropriate domains to be assessed, especially where studies are designed to capture the impact of the intervention at individual and societal level. Comparison of results from different studies and meta-analysis would be facilitated through the use of a core set of standardised outcome measures which cross all domains of the ICF. Further work on developing consensus on such a core set is needed.
Plomgaard, Anne M; van Oeveren, Wim; Petersen, Tue Hvass
BACKGROUND: The SafeBoosC phase II multicentre randomized clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline vs. no NIRS data and treatment as usual in the control group...... during the first 72 h of life. The trial demonstrated a significant reduction in the burden of cerebral hypoxia in the experimental group. We now report the blindly assessed and analyzed treatment effects on electroencephalographic (EEG) outcomes (burst rate and spectral edge frequency 95% (SEF95...
Raymond P. Guiteras
Full Text Available In many randomized trials, subjects enter the sample sequentially. Because the covariates for all units are not known in advance, standard methods of stratification do not apply. We describe and assess the method of DA-optimal sequential allocation (Atkinson, 1982 for balancing stratification covariates across treatment arms. We provide simulation evidence that the method can provide substantial improvements in precision over commonly employed alternatives. We also describe our experience implementing the method in a field trial of a clean water and handwashing intervention in Dhaka, Bangladesh, the first time the method has been used. We provide advice and software for future researchers.
Safi, Morteza; Mahjoob, Mohammad Parsa; Nateghi, Saeed; Khaheshi, Isa; Akbarzadeh, Mohammad Ali; Naderian, Mohammadreza
Recent studies have confirmed the essential and paramount role of the L-Citrulline on the nitric oxide regulation and the endothelial function improvement. In this cross-over clinical trial, thirty patients, diagnosed with coronary artery disease (CAD) and flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD) ratio less than 1, were included. The patients were randomly divided into two groups of 15 patients and underwent treatment by L-Citrulline or placebo for 15 days, in 2 step protocol. The indicators of assessment in the current study were the ratio of the FMD/NMD and FMD value. In the current cross-over clinical trial, the mean of FMD to NMD ratio and mean FMD value of all patients before starting the protocol were 0.91 ± 0.08 and 4.04 ± 0.51 mm, respectively. The final results of study showed that following L-Citrulline administration, mean FMD to NMD ratio and mean FMD value were enhanced to: 1.03 ± 0.09 and 4.96 ± 0.72 mm, respectively, which were statistically significant (PFMD to NMD ratio and mean FMD value were receded to: 0.92 ± 0.09 and 4.06 ± 0.22 mm, respectively, which were not statistically significant (P = 0.75 and P = 0.89, respectively). Moreover, the improvement of mean FMD to NMD ratio (0.12 ± 0.02) and mean FMD value (0.92 ± 0.16 mm), following L-Citrulline administration, were statistically significant in comparison with the change of mean FMD to NMD ratio (0.01 ± 0.002) and mean FMD value (0.02 ± 0.003), following placebo administration (PFMD to NMD ratio FMD value enhancements.
Sajobi, Tolulope T; Singh, Gurbakhshash; Lowerison, Mark W; Engbers, Jordan; Menon, Bijoy K; Demchuk, Andrew M; Goyal, Mayank; Hill, Michael D
We describe the implementation of minimal sufficient balance randomization, a covariate-adaptive randomization technique, used for the "Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times" (ESCAPE) trial. The ESCAPE trial is a prospective, multicenter, randomized clinical trial that enrolled subjects with the following main inclusion criteria: less than 12 h from symptom onset, age 18 years or older, baseline NIHSS score > 5, ASPECTS score > 5 and computed tomography angiography (CTA) evidence of carotid T/L or M1-segment middle cerebral artery (MCA) occlusion, and at least moderate collaterals by CTA. Patients were randomized using a real-time, dynamic, Internet-based, minimal sufficient balance randomization method that balanced the study arms with respect to baseline covariates including age, sex, baseline NIHSS score, site of arterial occlusion, baseline ASPECTS score and treatment with intravenously administered alteplase. Permutation-based tests of group differences confirmed group balance across several baseline covariates including sex (p = 1.00), baseline NIHSS score (p = 0.95), site of arterial occlusion (p = 1.00), baseline ASPECTS score (p = 0.28), treatment with intravenously administered alteplase (p = 0.31), and age (p = 0.67). Results from the ESCAPE trial demonstrate the feasibility and the benefit of this covariate adaptive randomization scheme in small-sample trials and for data monitoring endeavors. ESCAPE trial - NCT01778335 - at www.clinicaltrials.gov . Registered on 29 January 2013.
Full Text Available The PrePex is a WHO--prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex device and acts as the leading center of excellence providing training and formal guidelines. As part of the Government's efforts to improve PrePex implementation, it made efforts to improve the psychological acceptability of device by men, thus increasing uptake with VMMC in sub-Saharan Africa. Some men who underwent the PrePex procedure complained of foreskin odor while wearing the PrePex 3-7 days after it was placed. This complaint was identified as potential risk for uptake of the device. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor and patient foreskin hygiene technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a trial to test different hygiene-cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern. The main objective of the trial was to compare odor levels between three arms, having identical personal hygiene but different foreskin hygiene techniques using either clear water with soap during a daily shower, soapy water using a syringe, or chlorhexidine using a syringe. One hundred and one subjects were enrolled to the trial and randomly allocated into three trial arms. Using chlorhexidine solution daily almost completely eliminated odor, and was statistically significant more effective that the other two arms. The trial results suggest that odor from the foreskin, while wearing the PrePex device, could be related to the growth of anaerobic bacteria, which can be prevented by a chlorhexidine cleaning method. This finding can be used to increase acceptability by men when considering PrePex as one of the leading methods for HIV prevention in VMMC programs.
In individually randomized controlled trials, in addition to the primary outcome, information is often available on a number of covariates prior to randomization. This information is frequently utilized to undertake adjustment for baseline characteristics in order to increase precision of the estimation of average treatment effects; such adjustment is usually performed via covariate adjustment in outcome regression models. Although the use of covariate adjustment is widely seen as desirable for making treatment effect estimates more precise and the corresponding hypothesis tests more powerful, there are considerable concerns that objective inference in randomized clinical trials can potentially be compromised. In this paper, we study an empirical likelihood approach to covariate adjustment and propose two unbiased estimating functions that automatically decouple evaluation of average treatment effects from regression modeling of covariate-outcome relationships. The resulting empirical likelihood estimator of the average treatment effect is as efficient as the existing efficient adjusted estimators(1) when separate treatment-specific working regression models are correctly specified, yet are at least as efficient as the existing efficient adjusted estimators(1) for any given treatment-specific working regression models whether or not they coincide with the true treatment-specific covariate-outcome relationships. We present a simulation study to compare the finite sample performance of various methods along with some results on analysis of a data set from an HIV clinical trial. The simulation results indicate that the proposed empirical likelihood approach is more efficient and powerful than its competitors when the working covariate-outcome relationships by treatment status are misspecified.
Snyder John J
Full Text Available Abstract Background Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. Methods/Design The Prevention of Adult Caries Study (PACS is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v dental coating in preventing adult caries. Participants (n = 983 were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. Discussion This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA, would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. Trial Registration Number NCT00357877
Full Text Available Introduction: Disability related to chronic Low Back Pain (LBP is a multi-factorial phenomenon, associated with high social and health costs, with a prevalence ranging from 11 to 76%. Significant and long-lasting pain relief can be achieved with transforaminal epidural steroid injection. Surgery is indicated for those patients with progressive neurological deficits or severe LBP refractory to conservative measures. Aim: To evaluate the efficacy of transforaminal epidural steroid injection through pelvic angle measurement, pain and disability measurements in patients with LBP and radiculopathy. Materials and Methods: This prospective randomized controlled study was conducted in Department of Pain in ESI institute of pain management for the industrial workers at Kolkata, India between October 2015 and September 2016. Sixty patients aged between 18 to 60 years, who attended pain clinic with complaints of LBP with unilateral radiculopathy due to lumber disc herniation were included in this trial. Patients were divided into 2 groups (30 patients in each group; Group I: Test group received single transforaminal epidural steroid injection with deposteroid (20 mg and 0.25% bupivacaine (total 2 ml together with oral medications and exercises at day 0. Group II: Control group received only medications and exercises on day 0/visit 1. Each patient was followed up for one month at visit 2. Each patient was assessed with Numeric Rating Scale (NRS for pain intensity and modified Oswestry Disability Index (ODI for measurement for disability and pelvic angle measurement on affected side. Results: During study period, 60 confirmed patients were included in the analysis. NRS for pain intensity measurement between visit 1(V1 and 2 (V2, showed significant improvement (p-value is < 0.001 in group I. ODI scores between 2 visits showed better outcome in group I. Pelvic angle measurement of affected limb on second visit in both groups as compared to first visit, showed
Sinha, Yashwant K; Craig, Jonathan C; Sureshkumar, Premala; Hayen, Andrew; Brien, Jo-anne E
To determine whether randomized controlled trials of pharmacologic interventions in children are more likely to be biased than similar trials in adults. Trials involving only children and published in MEDLINE between January 2008 and October 2009 (n=100) were randomly selected and matched, by drug class and therapeutic area, with a similar trial completed in adults. The Cochrane risk of bias tool was used to compare the pediatric and adult trials. The characteristics of adult and pediatric trials included were similar, except that adult studies were more likely to be conducted in Europe and published in specialty journals. Two-thirds of all trials were single center, and 62% had 100 or fewer participants. Many trials had an unclear risk of bias for allocation concealment (65% adult, 52% pediatric). More pediatric trials had a low risk of bias for random sequence generation (59% pediatric, 41% adult, P=.002) and blinding of outcome assessment (63% pediatric, 48% adult, P=.04) than adult trials; however, a sensitivity analysis of trials published since 2008 (and so matched by year of publication) did not confirm this finding, suggesting year of publication was an important confounder. When randomized controlled trials are matched for drug class and therapeutic area, trials involving children display a similar risk of bias. Differences in the risk of bias between pediatric and adult trials are not caused by differences in the capacity of researchers to conduct and report trials of high quality. Copyright © 2014 Elsevier Inc. All rights reserved.
Marla J Keller
Full Text Available Preclinical and early phase clinical microbicide studies have not consistently predicted the outcome of efficacy trials. To address this gap, candidate biomarkers of microbicide pharmacodynamics and safety were evaluated in a double-blind, placebo-controlled trial of tenofovir gel, the first microbicide to demonstrate significant protection against HIV acquisition.30 women were randomized to apply a single daily dose of tenofovir or placebo gel for 14 consecutive days. Anti-HIV activity was measured in cervicovaginal lavage (CVL on Days 0, 3, 7, 14 and 21 by luciferase assay as a surrogate marker of pharmacodynamics. Endogenous activity against E. coli and HSV-2 and concentrations of immune mediators were quantified in CVL as candidate biomarkers of safety. Tenofovir levels were measured in CVL and blood.A significant increase in anti-HIV activity was detected in CVL from women who applied tenofovir gel compared to their endogenous anti-HIV activity in genital tract secretions on Day 0 and compared to activity in CVL from women in the placebo group. The activity correlated significantly with CVL concentration of tenofovir (r = 0.6, p<0.001 and fit a sigmoid E(max pharmacodynamic model. Anti-HIV activity in CVL from women who applied tenofovir persisted when virus was introduced in semen, whereas endogenous anti-HIV activity decreased. Tenofovir did not trigger an inflammatory response or induce sustained loss in endogenous antimicrobial activity or immune mediators.Tenofovir gel had no deleterious impact on soluble mucosal immunity. The increased anti-HIV activity in CVL, which persisted in the presence of semen and correlated with tenofovir concentration, is consistent with the efficacy observed in a recent clinical trial. These results promote quantified CVL anti-HIV activity as a surrogate of tissue pharmacodynamics and as a potential biomarker of adherence to product. This simple, feasible and inexpensive bioassay may promote the development
A Planned Prospective, Randomized, Placebo-Controlled Multicenter Trial Assessing the Effect of Helicobacter pylori Eradication on the Healing of Iatrogenic Ulcer after Endoscopic Resection of Gastric Neoplasm
Kim, Sang Gyun; Song, Ho June; Choi, Il Ju; Cho, Joo Young; Jung, Hwoon-Yong; Keum, Bora; Cheon, Jae Hee; Lee, Yong Chan; Kim, Jae Gyu; Park, Sue K.; Park, Byung Joo
Background/Aims Helicobacter pylori eradication may facilitate the healing of iatrogenic ulcer after endoscopic resection of gastric neoplasm. This study involved designing a randomized, double-blinded, placebo-controlled, multicenter trial, performed by the Korean College of Helicobacter and Upper Gastrointestinal Research and the Medical Research Collaboration Center, Seoul National University Hospital. Methods We intend to enroll up to 232 patients H.-pylori-positive patients who have gastric adenoma or early gastric cancer after endoscopic resection. The enrolled patients are being randomly allocated to the H.-pylori-eradication-plus-proton-pump-inhibitor group or the placebo-plus-proton-pump-inhibitor group based on their histology results and the size of the resected specimen. After random allocation, the iatrogenic ulcer size and stage are evaluated at 4- and 8-week follow-ups (with a window of ±7 days). The primary end point is the healing rate of the ulcer by stage, and the secondary end point is the rate of ulcer size reduction, relief rate from ulcer-related symptoms, and adverse-event rates. Results More than 90% of the target subjects have already been enrolled into the study and are receiving ongoing periodic monitoring by the Medical Research Collaboration Center. Conclusions Completion of the study should reveal whether H. pylori eradication can facilitate the healing of ulcer after endoscopic resection in Korea. PMID:21253301
Terevnikov, Viacheslav; Joffe, Grigori; Stenberg, Jan-Henry
Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors' efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups--plausibly due to differences in the mechanisms of action. Antidepressants may not worsen the course of psychosis. Better designed
Background A few observational studies have found an inverse association between adherence to a Mediterranean diet and the risk of depression. Randomized trials with an intervention based on this dietary pattern could provide the most definitive answer to the findings reported by observational studies. The aim of this study was to compare in a randomized trial the effects of two Mediterranean diets versus a low-fat diet on depression risk after at least 3 years of intervention. Methods This was a multicenter, randomized, primary prevention field trial of cardiovascular disease (Prevención con Dieta Mediterránea (PREDIMED Study)) based on community-dwelling men aged 55 to 80 years and women aged 60 to 80 years at high risk of cardiovascular disease (51% of them had type 2 diabetes; DM2) attending primary care centers affiliated with 11 Spanish teaching hospitals. Primary analyses were performed on an intention-to-treat basis. Cox regression models were used to assess the relationship between the nutritional intervention groups and the incidence of depression. Results We identified 224 new cases of depression during follow-up. There was an inverse association with depression for participants assigned to a Mediterranean diet supplemented with nuts (multivariate hazard ratio (HR) 0.78; 95% confidence interval (CI) 0.55 to 1.10) compared with participants assigned to the control group, although this was not significant. However, when the analysis was restricted to participants with DM2, the magnitude of the effect of the intervention with the Mediterranean diet supplemented with nuts did reach statistical significance (multivariate HR = 0.59; 95% CI 0.36 to 0.98). Conclusions The result suggest that a Mediterranean diet supplemented with nuts could exert a beneficial effect on the risk of depression in patients with DM2. Trial registration This trial has been registered in the Current Controlled Trials with the number ISRCTN 35739639 PMID:24229349
Hernández Josep M
Full Text Available Abstract Background Most depressed patients are attended at primary care. However, there are significant shortcomings in the diagnosis, management and outcomes of these patients. The aim of this study is to determine whether the implementation of a structured programme for managing depression will provide better health outcomes than usual management. Methods/Design Design: A cluster-randomized controlled trial involving two groups, one of which is the control group consisting of patients who are treated for depression in the usual way and the other is the intervention group consisting of patients on a structured programme for treating depression. Setting: 20 primary care centres in the province of Tarragona (Spain Sample: 400 patients over 18 years of age who have experienced an episode of major depression (DSM-IV and who need to initiate antidepressant treatment Intervention: A multi-component programme with clinical, educational and organisational procedures that includes training for the health care provider and evidence-based clinical guidelines. It also includes primary care nurses working as care-managers who provide educational and emotional support for the patients and who are responsible for active and systematic clinical monitoring. The programme aims to improve the primary care/specialized level interface. Measurements: The patients will be monitored by telephone interviews. The interviewer will not know which group the patient belongs to (blind trial. These interviews will be given at 0, 3, 6 and 12 months. Main variables: Severity of the depressive symptoms, response rate and remission rate. Analysis: Outcomes will be analyzed on an intent-to-treat basis and the unit of analysis will be the individual patient. This analysis will take into account the effect of study design on potential lack of independence between observations within the same cluster. Discussion The effectiveness of caring for depression in primary care can be
Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.
Introduction To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR. Methods Twenty newly diagnosed, glucocorticoid (GC) naïve patients with PMR and 20 matched non-PMR control subjects completed the trial. Subjects were randomized in a 1:1 ratio to monotherapy with etanercept (25 mg s.c. biweekly) or placebo (saline) for 14 days. Study outcomes were assessed at baseline and after 14 days. The primary outcome was the change in PMR activity score (PMR-AS). Secondary outcomes were: changes in erythrocyte sedimentation rate (ESR) and plasma levels of TNF-α and interleukin (IL) 6; patients' functional status (health assessment questionnaire) and cumulative tramadol intake during the trial. Results At baseline, plasma TNF-α was higher in patients than in controls (P etanercept treatment (P etanercept decreased PMR-AS by 24% (P = 0.011), reflecting significant improvements in shoulder mobility, physician's global assessment and C-reactive protein, and insignificant (P > 0.05) improvements in duration of morning stiffness and patient's assessment of pain. In parallel, ESR and IL-6 were reduced (P 0.05). Functional status did not change and tramadol intake did not differ between patient groups. In controls, no changes occurred in both groups. Conclusions Etanercept monotherapy ameliorates disease activity in GC naïve patients with PMR. However, the effect is modest, indicating a minor role of TNF-α in PMR. Trial registration ClinicalTrials.gov (NCT00524381). PMID:20854662
Deserno, Thomas M; Keszei, András P
Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization
Bhalla, R K; Watson, G; Taylor, W; Jones, A S; Roland, N J
To determine whether a corticosteroid dry-powder inhaler could reverse the pharyngeal and laryngeal side effects produced by a corticosteroid pressurised metered-dose inhaler. Prospective, randomized, controlled, cross-over, evaluator-blinded study. University Hospital Aintree, Liverpool, United Kingdom. Thirty-seven adults recruited over a 12-month period from Ear, Nose and Throat clinics at our University hospital. Patients were randomized into three groups using a computer-generated random number list and sealed opaque envelopes. Scores were achieved on respiratory symptom and vocal performance questionnaires. Acoustic analysis was performed followed by a standardized biopsy of the posterior pharyngeal wall. Histological markers of inflammation were correlated with pharyngitis. The data were tested for normality using the Kalmogorov-Smirnov test. The Kruskal-Wallis analysis of variance was used to investigate differences between medians and ranges. The data were further investigated for correlations using the Spearman test. Discriminant analysis was used to examine the effect of the three groups on each variable. Discomfort scores (median and range) were significantly lower after dry-powder inhaler use than with either a spacer or water gargle (p inhaler therapy. The reduction in pharyngitis in each of the three groups was not significant. Vocal performance scores improved with dry-powder inhaler use. Jitter, shimmer, and closed-phase quotient scores improved with dry-powder inhaler use (p inhaler was restored (p 0.01). A dry-powder inhaler may alleviate the local side effects produced by a pressurized metered-dose inhaler. Laryngeal dysfunction appears to be particularly responsive to the absence of propellant. More observational and randomized controlled trials are necessary to examine existing inhalers and specifically, how and why they cause local side effects.
Ibrügger, Sabine; Gøbel, Rikke Juul; Vestergaard, Henrik
Background: Gut microbiota composition and activity may be changed by dietary factors and possibly affect metabolic health. Dietary gluten and wholegrain are suggested to influence metabolism in a negative and positive direction, respectively. Objective: Describe the design and rational as well...... as baseline characteristics of two human intervention studies, within the Gut, Grain and Greens (3G) Center, investigating the effects of a gluten-poor and wholegrain-rich diet on microbiota composition and metabolic health. Design: The gluten and wholegrain studies had a randomized, controlled, cross......-over design each comprising two eight-week dietary intervention periods, separated by a six-week wash-out period. Each trial included 60 men and women exhibiting an increased metabolic risk. In the gluten study a gluten-poor diet was compared with a gluten-rich dietary fiber-controlled diet...
Rajapakse, Senaka; Chrishan Shivanthan, Mitrakrishnan; Samaranayake, Nilakshi; Rodrigo, Chaturaka; Deepika Fernando, Sumadhya
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.
Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will
Brinkhaus, Benno; Roll, Stephanie; Jena, Susanne; Icke, Katja; Adam, Daniela; Binting, Sylvia; Lotz, Fabian; Willich, Stefan N; Witt, Claudia M
Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone. Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months. A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group. In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.
Kim, Michael; Muntner, Paul; Sharma, Samin; Choi, James W; Stoler, Robert C; Woodward, Mark; Mann, Devin M; Farkouh, Michael E
Same-day discharge after percutaneous coronary intervention (PCI) may be safe for some patients. Few data are available on patient-reported outcomes and preferences for same-day discharge after PCI. Between March 2008 and March 2010, a total of 298 patients undergoing elective PCI via femoral access at 2 medical centers (Mount Sinai Hospital, New York, NY, and Baylor Medical Center, Dallas, TX) were randomized to same-day (n=150) or next-day (n=148) discharge. The primary outcome was high patient coping during the 7 days after discharge defined as scores <20 on the validated postdischarge coping difficulty scale. Safety outcomes, clopidogrel adherence, and patient preferences were secondary outcomes. Before discharge, patients randomized to same-day and next-day discharge were similar with respect to sociodemographic and clinical characteristics. High-coping ability, assessed 7 days after PCI, was present for 79% of patients randomized to same-day discharge and for 77% of patients randomized to next-day discharge. The difference in high coping ability, 2 (95% confidence interval, -7 to 11), did not cross the noninferiority threshold of -12% (P<0.001 that same-day discharge is not noninferior to next-day discharge). At 30 days after PCI, clopidogrel adherence, physician and emergency room visits, and hospitalization were similar in the 2 randomization groups. In addition, 80% and 68% of those randomized to same-day and next-day discharge, respectively, stated they would prefer same-day discharge if they were to have another PCI procedure. Same-day discharge after PCI was associated with patient-reported and clinical outcomes similar to those of next-day discharge and was preferred by most patients.
Skotheim, Siv; Dahl, Lisbeth; Handeland, Katina; Frøyland, Livar; Lie, Øyvind; Øyen, Jannike; Kjellevold, Marian; Stormark, Kjell Morten; Graff, Ingvild Eide
To describe the rationale, study design, population and dietary compliance in a randomized controlled trial (RCT) investigating the effect of fatty fish on cognitive performance and mental health in adolescents. In the Fish Intervention Studies-TEENS (FINS-TEENS) study we individually randomized 478 adolescents (14-15-year-olds) from eight secondary schools in Norway to receive school meal lunches with fatty fish or meat or n-3 supplements three times a week for 12 weeks. Demographic factors, psychological tests and biological measures were collected pre-and post-intervention. Duplicate portions of lunch meals were collected and individual intake recorded throughout the study. In total, 481 out of 785 adolescents (61%) agreed to participate and 34 (7%) dropped out. Breakfast consumption was the only group difference in background characteristics. Analyses of selected nutrients in the lunch meals showed higher levels of n-3 fatty acids, vitamin D and n-6 fatty acids in the fish compared to the meat meals. Dietary compliance (score 0-144) revealed that the intake in the Fish group (mean = 59, standard deviation (SD) = 35) were lower than in the Meat group (mean = 83, SD = 31, p fish in a school-based setting. The results also emphasize the importance of collecting detailed records of dietary compliance, as this information is important when interpreting and analysing the outcome of dietary interventions.
Hidderley, Margaret; Holt, Martin
Autogenic training (AT) is a type of meditation usually used for reducing stress. This pilot study describes how AT was used on a group of early stage cancer patients and the observed effect on stress-related behaviours and immune system responses. This was a randomized trial with 31 early stage breast cancer women, having received a lumpectomy and adjuvant radiotherapy. The women were randomized into two groups. Group 1 received a home visit only. Group 2 received a home visit and 2 months' weekly Autogenic training. At the beginning and end of the 2 monthly periods, the Hospital Anxiety and Depression Scale (HADS) and T and B cell markers were measured to give an indication of changes in immune system responses and measurement of anxiety and depression. At the end of the study, HADS scores and T and B cell markers remained similar in the women who did not receive AT. The women receiving AT showed a strong statistical difference for an improvement in their HADS scores and those women observed in a meditative state as opposed to a relaxed state were found to have an increase in their immune responses. This study suggests AT as a powerful self-help therapy.
Moll Frans L
Full Text Available Abstract Background Peripheral arterial disease (PAD is a common disease associated with a considerably increased risk of future cardiovascular events and most of these patients will die from coronary artery disease (CAD. Screening for silent CAD has become an option with recent non-invasive developments in CT (computed tomography-angiography and MR (magnetic resonance stress testing. Screening in combination with more aggressive treatment may improve prognosis. Therefore we propose to study whether a cardiac imaging algorithm, using non-invasive imaging techniques followed by treatment will reduce the risk of cardiovascular disease in PAD patients free from cardiac symptoms. Design The GROUND study is designed as a prospective, multi-center, randomized clinical trial. Patients with peripheral arterial disease, but without symptomatic cardiac disease will be asked to participate. All patients receive a proper risk factor management before randomization. Half of the recruited patients will enter the 'control group' and only undergo CT calcium scoring. The other half of the recruited patients (index group will undergo the non invasive cardiac imaging algorithm followed by evidence-based treatment. First, patients are submitted to CT calcium scoring and CT angiography. Patients with a left main (or equivalent coronary artery stenosis of > 50% on CT will be referred to a cardiologist without further imaging. All other patients in this group will undergo dobutamine stress magnetic resonance (DSMR testing. Patients with a DSMR positive for ischemia will also be referred to a cardiologist. These patients are candidates for conventional coronary angiography and cardiac interventions (coronary artery bypass grafting (CABG or percutaneous cardiac interventions (PCI, if indicated. All participants of the trial will enter a 5 year follow up period for the occurrence of cardiovascular events. Sequential interim analysis will take place. Based on sample size
Henry, James A; Loovis, Carl; Montero, Melissa; Kaelin, Christine; Anselmi, Kathryn-Anne; Coombs, Rebecca; Hensley, June; James, Kenneth E
.... We conducted a randomized clinical trial to test the hypothesis that group educational counseling based on TRT principles would effectively treat veterans who have clinically significant tinnitus...
Engers, AJ; Wensing, M.; van Tulder, M.; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.
STUDY DESIGN.: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES.: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence
Melchart, Dieter; Doerfler, Wolfgang; Eustachi, Axel; Wellenhofer-Li, Yanqing; Weidenhammer, Wolfgang
Overweight is considered an important risk factor for diseases in the context of metabolic syndrome. Lifestyle modifications are the means of choice to reduce weight in persons with a Body Mass Index of 28 to 35. The study examines whether there are any differences between two intervention strategies regarding weight reduction in overweight persons. The study is a multicentre randomized controlled trial with observation duration of 12 months. Eight study centres are involved to include a minimal sample size of 150 participants. Randomization ratio is 2:1. Feasible persons are checked according to inclusion and exclusion criteria and after given informed consent are assigned randomly to one of two intervention programs: A) intervention group: comprehensive lifestyle modification program (Individual Health Management IHM) with 3 months reduction phase plus 9 months maintaining phase, B) control group: written information with advice for healthy food habits (Usual care UC). Participants of the IHM group have access to a web-based health portal and join 3 full-day and 10 two-hour training sessions during the first 3 months. During the remaining 9 months four refresh trainings will be performed. There are 3 different diet strategies (fasting, two-day diet, meal replacement) for free choice. Participants of the control group are provided with acknowledged rules for healthy food according to the German Nutrition Society (DGE). Examinations are conducted at baseline, after 3, 6, 9 and 12 months. They include body weight, waist circumference, blood pressure, laboratory findings and a bio-impedance analysis to measure body composition. Statistical analysis of the primary outcome 'change of body weight after 12 months' is based on ITT population including analysis of variance of the weight differences between month 0 and 12 with the factors 'group', 'baseline value' and 'study centre'. Secondary outcomes will be analyzed exploratively. The monitoring of the study will
Cao, Huijuan; Li, Xun; Yan, Xue; Wang, Nissi S.; Bensoussan, Alan; Liu, Jianping
Objective: Cupping as a traditional therapy is used to treat a myriad of health conditions, including pain. This systematic review assessed the effectiveness and safety of cupping for different types of pain. Methods: Thirteen databases and four trial registries were searched for randomized clinical trials. Meta-analysis of data was conducted if there was non-significant clinical and statistical heterogeneity (measured by I2 test) among trials. Results: Sixteen trials with 921 participa...
Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J
BACKGROUND: Naproxen, ibuprofen and diclofenac are frequently used as comparators in randomized controlled trials (RCTs) on the safety and efficacy of cyclooxygenase (COX)-2 inhibitors. Different comparator doses may influence the results of RCTs. It has been hypothesized that RCTs of COX-2...... 1995 and 2009 in which celecoxib or rofecoxib were compared with naproxen, ibuprofen or diclofenac. All articles labelled as RCTs mentioning rofecoxib or celecoxib and one or more of the comparator drugs in the title and/or abstract were included. We extracted information on doses of both non...... dose trends in the case of rofecoxib. CONCLUSIONS: Although the dose trends over time differed for RCTs comparing rofecoxib and celecoxib with diclofenac, ibuprofen or naproxen, the results of our study do not support the hypothesis that dose trends influenced the decision to continue marketing...
Kielbassa Andrej M
Full Text Available Abstract Background Hyposalivation is caused by various syndromes, diabetes, drugs, inflammation, infection, or radiotherapy of the salivary glands. Patients with hyposalivation often show an increased caries incidence. Moreover, hyposalivation is frequently accompanied by oral discomfort and impaired oral functions, and saliva substitutes are widely used to alleviate oral symptoms. However, preference of saliva substitutes due to taste, handling, and relief of oral symptoms has been discussed controversially. Some of the marketed products have shown demineralizing effects on dental hard tissues in vitro. This demineralizing potential is attributed to the undersaturation with respect to calcium phosphates. Therefore, it is important to modify the mineralizing potential of saliva substitutes to prevent carious lesions. Thus, the aim of the present study was to evaluate the effects of a possible remineralizing saliva substitute (SN; modified Saliva natura compared to a demineralizing one (G; Glandosane on mineral parameters of sound bovine dentin and enamel as well as on artificially demineralized enamel specimens in situ. Moreover, oral well-being after use of each saliva substitute was recorded. Methods/Design Using a randomized, double-blind, crossover, phase II/III in situ trial, volunteers with hyposalivation utilize removable dentures containing bovine specimens during the experimental period. The volunteers are divided into two groups, and are required to apply both saliva substitutes for seven weeks each. After both test periods, differences in mineral loss and lesion depth between values before and after exposure are evaluated based on microradiographs. The oral well-being of the volunteers before and after therapy is determined using questionnaires. With respect to the microradiographic analysis, equal mineral losses and lesion depths of enamel and dentin specimens during treatment with SN and G, and no differences in patients
Makarem, Abbas; Ravandeh, Navid; Ebrahimi, Masoumeh
Background and aims. The superiority of rotary systems has been reported in several clinical studies on permanent teeth. This study consisted of radiographic assessment and chair time of rotary instruments in the pulpectomy of primary second molar teeth. Materials and methods. In this randomized controlled clinical study, 46 children, 3-6 years of age, were selected. The patients were divided randomly into two groups. In the first group (group A) pulpectomy was carried out with hand instruments and in the second group (group B) the Rotary FlexMaster System was used. T-test and chi-squared test were used to analyze data. Results. The mean instrumentation time in group A was significantly more than that in group B (Protary instruments in second primary molar teeth were achieved.
Wu, Sheng; Wong, Weng Kee; Crespi, Catherine M.
Summary We consider design issues for cluster randomized trials (CRTs) with a binary outcome where both unit costs and intraclass correlation coefficients (ICCs) in the two arms may be unequal. We first propose a design that maximizes cost efficiency (CE), defined as the ratio of the precision of the efficacy measure to the study cost. Because such designs can be highly sensitive to the unknown ICCs and the anticipated success rates in the two arms, a local strategy based on a single set of best guesses for the ICCs and success rates can be risky. To mitigate this issue, we propose a maximin optimal design that permits ranges of values to be specified for the success rate and the ICC in each arm. We derive maximin optimal designs for three common measures of the efficacy of the intervention, risk difference, relative risk and odds ratio, and study their properties. Using a real cancer control and prevention trial example, we ascertain the efficiency of the widely used balanced design relative to the maximin optimal design and show that the former can be quite inefficient and less robust to mis-specifications of the ICCs and the success rates in the two arms. PMID:28182835
Orenstein, Susan R; Hassall, Eric; Furmaga-Jablonska, Wanda; Atkinson, Stuart; Raanan, Marsha
To assess the efficacy and safety of lansoprazole in treating infants with symptoms attributed to gastroesophageal reflux disease (GERD) that have persisted despite a >or= 1-week course of nonpharmacologic management. This multicenter, double-blind, parallel-group study randomized infants with persisting symptoms attributed to GERD to treatment with lansoprazole or placebo for 4 weeks. Symptoms were tracked through daily diaries and weekly visits. Efficacy was defined primarily by a >or= 50% reduction in measures of feeding-related crying and secondarily by changes in other symptoms and global assessments. Safety was assessed based on the occurrence of adverse events (AEs) and clinical/laboratory data. Of the 216 infants screened, 162 met the inclusion/exclusion criteria and were randomized. Of those, 44/81 infants (54%) in each group were responders--identical for lansoprazole and placebo. No significant lansoprazole-placebo differences were detected in any secondary measures or analyses of efficacy. During double-blind treatment, 62% of lansoprazole-treated subjects experienced 1 or more treatment-emergent AEs, versus 46% of placebo recipients (P= .058). Serious AEs (SAEs), particularly lower respiratory tract infections, occurred in 12 infants, significantly more frequently in the lansoprazole group compared with the placebo group (10 vs 2; P= .032). This study detected no difference in efficacy between lansoprazole and placebo for symptoms attributed to GERD in infants age 1 to 12 months. SAEs, particularly lower respiratory tract infections, occurred more frequently with lansoprazole than with placebo.
Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P Study, a randomized controlled trial
Rejeski W Jack
Full Text Available Abstract Background The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. Methods SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA and/or cognitive training intervention (CT in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. Results Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004, the interventions produced marked changes in cognitive and physical performance measures (p≤0.05, and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01. Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome or 2,000 participants (categorical outcome. Conclusions Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. Trial Registration Clinicaltrials.gov Identifier: NCT00688155
De Santis, Maria; Bellmunt, Joaquim; Mead, Graham
This is the first randomized phase II/III trial comparing two carboplatin-based chemotherapy regimens in patients with urothelial cancer who are ineligible ("unfit") for cisplatin chemotherapy.......This is the first randomized phase II/III trial comparing two carboplatin-based chemotherapy regimens in patients with urothelial cancer who are ineligible ("unfit") for cisplatin chemotherapy....
McEvoy, Peter M; Moulds, Michelle L; Grisham, Jessica R; Holmes, Emily A; Moscovitch, David A; Hendrie, Delia; Saulsman, Lisa M; Lipp, Ottmar V; Kane, Robert T; Rapee, Ronald M; Hyett, Matthew P; Erceg-Hurn, David M
Cognitive behavior group therapy (CBGT) is effective for social anxiety disorder (SAD), but a substantial proportion of patients do not typically achieve normative functioning. Cognitive behavioral models of SAD emphasize negative self-imagery as an important maintaining factor, and evidence suggests that imagery is a powerful cognitive mode for facilitating affective change. This study will compare two group CBGT interventions, one that predominantly uses verbally-based strategies (VB-CBGT) and another that predominantly uses imagery-enhanced strategies (IE-CBGT), in terms of (a) efficacy, (b) mechanisms of change, and (c) cost-effectiveness. This study is a parallel groups (two-arm) single-blind randomized controlled trial. A minimum of 96 patients with SAD will be recruited within a public outpatient community mental health clinic in Perth, Australia. The primary outcomes will be self-reported symptom severity, caseness (SAD present: yes/no) based on a structured diagnostic interview, and clinician-rated severity and life impact. Secondary outcomes and mechanism measures include blind observer-rated use of safety behaviors, physiological activity (heart rate variability and skin conductance level) during a standardized speech task, negative self-beliefs, imagery suppression, fear of negative and positive evaluation, repetitive negative thinking, anxiety, depression, self-consciousness, use of safety behaviors, and the EQ-5D-5L and TiC-P for the health economic analysis. Homework completion, group cohesion, and working alliance will also be monitored. The outcomes of this trial will inform clinicians as to whether integrating imagery-based strategies in cognitive behavior therapy for SAD is likely to improve outcomes. Common and distinct mechanisms of change might be identified, along with relative cost-effectiveness of each intervention. Copyright © 2017 Elsevier Inc. All rights reserved.
A pilot single-centre randomized trial assessing the safety and efficacy of lateral pararectus abdominis compared with transrectus abdominis muscle stoma placement in patients with temporary loop ileostomies: the PATRASTOM trial.
Hardt, J; Seyfried, S; Weiß, C; Post, S; Kienle, P; Herrle, F
Transrectal stoma placement is considered the standard technique for positioning a stoma. A prospective series using a novel method of lateral pararectal stoma placement recently revealed a remarkably low stoma herniation rate. A randomized trial was conducted to compare the lateral pararectal with the transrectal stoma position with regard to parastomal herniation, stoma-related morbidity and quality of life. Adult patients undergoing elective placement of a temporary loop ileostomy were eligible for inclusion. Patients were intra-operatively randomized to undergo either a lateral pararectal or a transrectal ileostomy. The primary end-point was the rate of parastomal herniation. Secondary end-points included other stoma-related complications and quality of life. Sample size calculation resulted in 54 patients having to be analysed to detect a difference of parastomal herniation of 30% with an 80% power and a 5% significance level. The trial was registered with the German Clinical Trials Register (registration number DRKS00003534). Between April 2012 and April 2014, 30 patients were randomized to each group. The incidence of parastomal herniation did not differ between the lateral pararectal (5 of 27) and the transrectal group (4 of 29; P = 0.725). There was also no significant difference regarding other stoma-related complications and the EORTC quality of life scales C30 and CR29. The incidence of parastomal herniation and other stoma-related complications did not differ between the groups. However, due to the limited sample size a small difference in favour of one of the two stoma placement techniques cannot be entirely ruled out. Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.
Sanclemente, G; Mancilla, G A; Hernandez, G
Daylight PDT (dPDT) is easy to use and does not require light equipment. Such therapy has been exhaustively proved to be successful in the treatment of actinic keratosis, but its use in skin photodamage remains unclear. To evaluate dPDT's efficacy in skin facial photodamage. This was a parallel-group double-blind, randomized placebo-controlled trial. Sixty participants with symmetric facial photodamage were allocated to topical methyl aminolevulinate (MAL) and daylight vs. matching placebo and daylight. Primary outcome was global photodamage improvement/failure 1 month after the third session. Secondary outcomes included: pain evaluation; specific photodamage severity scores; sun irradiance quantification and Skindex-29 scores. Adverse events were also investigated. Primary analysis included all randomized patients. All patients sun-exposed for 120min in 3 sessions. The risk of failure was lower in the MAL-dPDT group than in the placebo plus daylight group (RR: 0.18; 95% CI: 0.08-0.41). Mean solar irradiance (W/m(2)) during the first, second and third sessions was 480.82, 430.07 and 435.84, respectively. Items 5 and 14 of Skindex-29 in the MAL-dPDT group showed statistical significant differences. Two patients in the MAL-dPDT group had serious and non-serious events not directly related to the product. dPDT with MAL was un-painful, effective and safe for the treatment of facial photodamage. Herpes simplex prophylaxis should be considered before sessions. Copyright © 2015 AEDV. Published by Elsevier España, S.L.U. All rights reserved.
Assessment of contamination and misclassification biases in a randomized controlled trial of a social network peer education intervention to reduce HIV risk behaviors among drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand.
Simmons, Nicole; Donnell, Deborah; Ou, San-San; Celentano, David D; Aramrattana, Apinun; Davis-Vogel, Annet; Metzger, David; Latkin, Carl
Controlled trials of HIV prevention and care interventions are susceptible to contamination. In a randomized controlled trial of a social network peer education intervention among people who inject drugs and their risk partners in Philadelphia, PA and Chiang Mai, Thailand, we tested a contamination measure based on recall of intervention terms. We assessed the recall of test, negative and positive control terms among intervention and control arm participants and compared the relative odds of recall of test versus negative control terms between study arms. The contamination measures showed good discriminant ability among participants in Chiang Mai. In Philadelphia there was no evidence of contamination and little evidence of diffusion. In Chiang Mai there was strong evidence of diffusion and contamination. Network structure and peer education in Chiang Mai likely led to contamination. Recall of intervention materials can be a useful method to detect contamination in experimental interventions.
Ahlqvist, Jan B; Nilsson, Tore A; Hedman, Leif R; Desser, Terry S; Dev, Parvati; Johansson, Magnus; Youngblood, Patricia L; Cheng, Robert P; Gold, Garry E
A simulator for virtual radiographic examinations was developed. In the virtual environment, the user can perform and analyze radiographic examinations of patient models without the use of ionizing radiation. We investigated if this simulation technique could improve education of radiology technology students. We compared student performance in the assessment of radiographic image quality after training with a conventional manikin or with the virtual radiography simulator. A randomized controlled experimental study involving 31 first-year radiology technology students was performed. It was organized in 4 phases as follows: (I) randomization to control or experimental group based on the results of an anatomy examination; (II) proficiency testing before training; (III) intervention (control group, exposure and analysis of radiographic images of the cervical spine of a manikin; experimental group, exposure and analysis of the cervical spine images in the virtual radiography simulator); and (IV) proficiency testing after training. The experimental group showed significantly higher scores after training compared with those before training (P Virtual radiographic simulation is an effective tool for learning image quality assessment. Simulation can therefore be a valuable adjunct to traditional educational methods and reduce exposure to x-rays and tutoring time.
Taudorf, Elisabeth H; Danielsen, Patricia L; Paulsen, Ida F; Togsverd-Bo, Katrine; Dierickx, Christine; Paasch, Uwe; Haedersdal, Merete
Non-ablative fractional laser-treatment is evolving for burn scars. The objective of this study was to evaluate clinical and histological long-term outcome of 1,540 nm fractional Erbium: Glass laser, targeting superficial, and deep components of mature burn scars. Side-by-side scar-areas were randomized to untreated control or three monthly non-ablative fractional laser-treatments using superficial and extra-deep handpieces. Patient follow-up were at 1, 3, and 6 months. Primary outcome was improvement in overall scar-appearance on a modified-Patient-and-Observer-Scar-Assessment-Scale (mPOSAS, 1 = "normal skin", 10 = "worst imaginable scar"). Secondary outcomes included histology, patient satisfaction (0-10), patient-assessed improvement, and safety. Study was completed by 17 of 20 randomized patients with normotrophic (n = 11), hypertrophic (n = 5) or atrophic (n = 1) scars. Scar-appearance improved from laser-treatments (P ablative fractional laser-treatments induce long-term clinical and histological improvement of mature burn scars. © 2014 Wiley Periodicals, Inc.
Assessment of the effeCt of lIfestyle iNtervention plus water-soluble ciNnAMon extract On loweriNg blood glucose in pre-diabetics, a randomized, double-blind, multicenter, placebo controlled trial: study protocol for a randomized controlled trial.
Crawford, Paul; Thai, Chuong; Obholz, Joshua; Schievenin, Jeffrey; True, Mark; Shah, Sachin A; Hallgren, John; Clark, Jill; Sharon, Danny
The World Health Organization predicts that by 2030 diabetes will be the seventh leading cause of death in the world. Multiple studies have tried to determine if cinnamon is an effective treatment for diabetes. Cinnamon extract is an insulin sensitizer, protects mesangial cells, decreases inflammatory markers, and lowers glucose, lipids, and blood pressure in patients with type 2 diabetes, so we developed a protocol to study whether ingestion of water-soluble cinnamon extract prevents progression from pre-diabetes to diabetes. This is a randomized, double-blind, placebo-controlled trial comparing cinnamon extract versus placebo in subjects with pre-diabetes who have committed to participate in a lifestyle change program. The trial will be conducted at five sites and will include 428 subjects who take cinnamon extract or placebo for 1 year. Follow-up for these subjects will be for a total of 2 years (nine study visits). The primary outcomes to be assessed are 1) conversion of patients from pre-diabetes to diabetes and 2) impact of water-soluble cinnamon extract on hepatic transaminases, renal function, and QT interval on electrocardiogram. Secondary outcomes include changes in HbA1c, lipids, waist circumference, weight, blood pressure, and fasting plasma glucose. The trial protocol has been approved by the Institutional Review Board of the US Air Force 59th Medical Wing, Wilford Hall Ambulatory Surgical Center (Protocol FWH20110035H). Investigator-sponsored Investigational New Drug status (114078) was granted by the US Food and Drug Administration. This study will provide high-quality evidence of the efficacy of water-soluble cinnamon extract in conjunction with lifestyle intervention for preventing patients with pre-diabetes from converting to diabetes. Additionally, it will provide important safety information about water-soluble cinnamon extract. ClinicalTrials.gov Identifier: NCT01301521 , 18 February 2011.
Lambers Heerspink, Hiddo Jan
Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious
Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: the Seniors Health and Activity Research Program Pilot (SHARP-P) study, a randomized controlled trial.
Legault, Claudine; Jennings, Janine M; Katula, Jeffrey A; Dagenbach, Dale; Gaussoin, Sarah A; Sink, Kaycee M; Rapp, Stephen R; Rejeski, W Jack; Shumaker, Sally A; Espeland, Mark A
The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA) and/or cognitive training intervention (CT) in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004), the interventions produced marked changes in cognitive and physical performance measures (p≤0.05), and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p=0.01). Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome) or 2,000 participants (categorical outcome). Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. Clinicaltrials.gov Identifier: NCT00688155. © 2011 Legault et al; licensee BioMed Central Ltd.
Hettema, Willem; Wynne, Christopher; Lang, Benjamin; Altendorfer, Mario; Czeloth, Niklas; Lohmann, Ragna; Athalye, Sandeep; Schliephake, Dorothee
This Phase I trial (INVICTAN®-1) evaluated three-way bioequivalence and safety of BI 695502 a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin®, Genentech; EU-approved Avastin, Roche). Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary end point to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early. The primary end point was area under the concentration-time curve (AUC) of the analyte in plasma from time zero extrapolated to infinity (AUC0-∞). Other pharmacokinetic (PK) parameters, safety, and in vitro binding affinity were also evaluated. The interim analysis demonstrated three-way bioequivalence for all comparisons. The confidence intervals around the geometric mean ratios of the primary and secondary PK parameters were within the predefined acceptance ranges. Study drugs were well tolerated with no clinically relevant differences in safety. BI 695502 and US- and EU-approved Avastin showed three-way bioequivalence with similar safety profile. NCT01608087.
Meattini, Icro; Curigliano, Giuseppe; Terziani, Francesca; Becherini, Carlotta; Airoldi, Mario; Allegrini, Giacomo; Amoroso, Domenico; Barni, Sandro; Bengala, Carmelo; Guarneri, Valentina; Marchetti, Paolo; Martella, Francesca; Piovano, Pierluigi; Vannini, Agnese; Desideri, Isacco; Tarquini, Roberto; Galanti, Giorgio; Barletta, Giuseppe; Livi, Lorenzo
Over the years, thanks to the addition of new generation systemic agents, as well as the use of more advanced and precise radiotherapy techniques, it was able to obtain a high curability rate for breast cancer. Anthracyclines play a key role in the treatment of breast disease, with a well-known benefit on disease-free survival of patients with positive nodal status. Trastuzumab have shown a significant outcome advantage after 1-year administration in case of HER2-positive disease. Unfortunately, significant increase in cardiotoxicity has been observed after anthracyclines and trastuzumab therapies. Even though the cardiology and oncology community strongly recommend a cardiotoxicity prevention strategy for this subset of patients, there is still no consensus on the optimal patient's approach. We aimed to review the published and ongoing researches on cardioprevention strategies and to present the SAFE trial (CT registry ID: NCT2236806; EudraCT number: 2015-000914-23). It is a randomized phase 3, four-arm, single-blind, placebo-controlled study that aims to evaluate the effect of bisoprolol, ramipril or both drugs, compared to placebo, on subclinical heart damage evaluated by speckle tracking cardiac ultrasound in non-metastatic breast cancer patients.
Vahdatpour, Babak; Sajadieh, Sepideh; Bateni, Vahid; Karami, Mehdi; Sajjadieh, Hamidreza
Background and Aim: Results of previous studies have been conflicting on the efficacy of extracorporeal shock wave therapy (ESWT) in the treatment of plantar fasciitis. We evaluated the effects of ESWT on plantar fasciitis in terms of ultrasonographic and subjective evaluations. Materials and Methods: In this randomized placebo-controlled trial, patients with plantar fasciitis were assigned to receive ESWT (4000 shock waves/session of 0.2 mJ/mm2) in 3 sessions at weekly intervals) or sham therapy (n = 20 in each group). Outcomes were documented by the ultrasonographic appearance of the aponeurosis and by patients’ pain scores, performed at baseline and 12 weeks after completion of the therapy. Results: The two groups were similar in baseline characteristics. Over the study period, plantar fascia thickness significantly reduced in the ESWT group (4.1 ± 1.3 to 3.6 ± 1.2 mm, P plantar fasciitis and ultrasound imaging is able to depict the morphologic changes related to plantar fasciitis as a result of this therapy. PMID:23826009
Full Text Available Studies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education.To investigate women's acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India.Secondary outcome of a randomised, controlled, non-inferiority trial.Outpatient primary health care clinics in rural and urban Rajasthan, India.Women were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85 mg/l and were below 18 years.Abortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1:1 in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol, using opaque sealed envelopes. Blinding during outcome assessment was not possible.Women's acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups.731 women were randomized to the clinic follow-up group (n = 353 or home-assessment group (n = 378. 623 (85% women were successfully followed up, of those 597 (96% were satisfied and 592 (95% found the abortion better or as expected, with no difference between study groups. The majority, 355 (57% women, preferred home-assessment in the event of a future abortion. Significantly more women, 284 (82%, in the home-assessment group preferred
Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.
BACKGROUND: The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health
Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.
Background The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health
Liaw, Sok Ying; Chan, Sally Wai-Chi; Chen, Fun-Gee; Hooi, Shing Chuan; Siau, Chiang
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 (Pvirtual 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.
Reginaldo Roque Mafetoni
Full Text Available Abstract OBJECTIVE Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. METHOD This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. RESULTS No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes; caesarean section rates were higher in the placebo group (50% and the same in the other groups (10%. CONCLUSION Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj.
King, G.J.; Spiekerman, C.F.; Greenlee, G.M.; Huang, G.J.
Focusing public insurance programs on interceptive orthodontics (IO) may increase access for low-income children. This report presents outcomes from a randomized clinical trial (RCT) comparing IO with comprehensive orthodontics (CO) in Medicaid patients. One hundred seventy pre-adolescents with Medicaid-eligible malocclusions were randomized to IO (n = 86) followed by observation (OBS) or OBS followed by CO (n = 84). One hundred thirty-four completed the trial. Models at pre-treatment (baseline) and following ≤ 2 years of intervention and 2 years of OBS (48 mos) were scored by calibrated examiners using the Peer Assessment Rating (PAR) and Index of Complexity, Outcome and Need (ICON). Overall outcomes and clinically meaningful categorical ICON data on need/acceptability, complexity, and improvement were compared. At baseline, groups were balanced by age, gender, ethnicity, and PAR/ICON scores. Most were minorities. Most (77%) were rated as difficult-to-very difficult. Scores improved significantly for both groups, but CO more than IO (PAR, 18.6 [95%CI 15.1, 22.1] vs.10.1 [95%CI 6.7, 13.4]; ICON, 44.8 [95% CI 39.7, 49.9] vs. 35.2 [95%CI 29.7, 40.6], respectively). On average, IO is effective at reducing malocclusions in Medicaid patients, but less than CO. (ClinicalTrials.gov number CT00067379) PMID:22699670
A randomized trial to assess the impact of opinion leader endorsed evidence summaries on the use of secondary prevention strategies in patients with coronary artery disease: the ESP-CAD trial protocol [NCT00175240].
McAlister, Finlay A; Fradette, Miriam; Graham, Michelle; Majumdar, Sumit R; Ghali, William A; Williams, Randall; Tsuyuki, Ross T; McMeekin, James; Grimshaw, Jeremy; Knudtson, Merril L
Although numerous therapies have been shown to be beneficial in the prevention of myocardial infarction and/or death in patients with coronary disease, these therapies are under-used and this gap contributes to sub-optimal patient outcomes. To increase the uptake of proven efficacious therapies in patients with coronary disease, we designed a multifaceted quality improvement intervention employing patient-specific reminders delivered at the point-of-care, with one-page treatment guidelines endorsed by local opinion leaders ("Local Opinion Leader Statement"). This trial is designed to evaluate the impact of these Local Opinion Leader Statements on the practices of primary care physicians caring for patients with coronary disease. In order to isolate the effects of the messenger (the local opinion leader) from the message, we will also test an identical quality improvement intervention that is not signed by a local opinion leader ("Unsigned Evidence Statement") in this trial. Randomized trial testing three different interventions in patients with coronary disease: (1) usual care versus (2) Local Opinion Leader Statement versus (3) Unsigned Evidence Statement. Patients diagnosed with coronary artery disease after cardiac catheterization (but without acute coronary syndromes) will be randomly allocated to one of the three interventions by cluster randomization (at the level of their primary care physician), if they are not on optimal statin therapy at baseline. The primary outcome is the proportion of patients demonstrating improvement in their statin management in the first six months post-catheterization. Secondary outcomes include examinations of the use of ACE inhibitors, anti-platelet agents, beta-blockers, non-statin lipid lowering drugs, and provision of smoking cessation advice in the first six months post-catheterization in the three treatment arms. Although randomization will be clustered at the level of the primary care physician, the design effect is
Full Text Available Background and aims. The superiority of rotary systems has been reported in several clinical studies on permanent teeth. This study consisted of radiographic assessment and chair time of rotary instruments in the pulpectomy of primary second molar teeth. Materials and methods. In this randomized controlled clinical study, 46 children, 3-6 years of age, were selected. The patients were divided randomly into two groups. In the first group (group A pulpectomy was carried out with hand instruments and in the second group (group B the Rotary FlexMaster System was used. T-test and chi-squared test were used to analyze data. Results. The mean instrumentation time in group A was significantly more than that in group B (P < 0.001. Also there was a significant difference between both groups in relation to the distance between the apex of mesial root (P < 0.001 and distal root (P = 0.007 and the canal filling level. Conclusion. Superior radiographic findings and less chair time of pulpectomy with rotary instruments in second primary molar teeth were achieved.
The Anesthesia Preoperative Evaluation Clinic (APEC): a prospective randomized controlled trial assessing impact on consultation time, direct costs, patient education and satisfaction with anesthesia care.
Schiff, J H; Frankenhauser, S; Pritsch, M; Fornaschon, S A; Snyder-Ramos, S A; Heal, C; Schmidt, K; Martin, E; Böttiger, B W; Motsch, J
Anesthetic preoperative evaluation clinics (APECs) are relatively new institutions. Although cost effective, APECs have not been universally adopted in Europe. The aim of this study was to compare preoperative anesthetic assessment in wards with an APEC, assessing time, information gain, patient satisfaction and secondary costs. Two hundred and seven inpatients were randomized to be assessed at the APEC or on the ward by the same two senior anesthetists. The outcomes measured were the length of time for each consultation, the amount of information passed on to patients and the level of patient satisfaction. The consultation time was used to calculate impact on direct costs. A multivariate analysis was conducted to detect confounding variables. Ninety-four patients were seen in the APEC, and 78 were seen on the ward. The total time for the consultation was shorter for the APEC (mean 8.4 minutes [PAPEC (PAPEC reduced consultation times and costs and had a positive impact on patient education. The cost savings are related to personnel costs and, therefore, are independent of other potential savings of an APEC, whereas global patient satisfaction remains unaltered.
Querstret, Dawn; Cropley, Mark; Fife-Schaw, Chris
This study aimed to extend our theoretical understanding of how mindfulness-based interventions exert their positive influence on measures of occupational health. Employing a randomized waitlist control study design, we sought to (a) assess an Internet-based instructor-led mindfulness intervention for its effect on key factors associated with "recovery from work," specifically, work-related rumination, fatigue, and sleep quality; (b) assess different facets of mindfulness (acting with awareness, describing, nonjudging, and nonreacting) as mechanisms of change; and (c) assess whether the effect of the intervention was maintained over time by following up our participants after 3 and 6 months. Participants who completed the mindfulness intervention (n = 60) reported significantly lower levels of work-related rumination and fatigue, and significantly higher levels of sleep quality, when compared with waitlist control participants (n = 58). Effects of the intervention were maintained at 3- and 6-month follow-up with medium to large effect sizes. The effect of the intervention was primarily explained by increased levels of only 1 facet of mindfulness (acting with awareness). This study provides support for online mindfulness interventions to aid recovery from work and furthers our understanding with regard to how mindfulness interventions exert their positive effects. (PsycINFO Database Record (c) 2017 APA, all rights reserved).
Giulliano Peixoto Gonçalves
Full Text Available OBJETIVO: O ensaio clínico aleatório é um estudo prospectivo que compara o efeito e o valor das intervenções em seres humanos, utilizando um ou mais grupos contra o grupo controle. O objetivo deste estudo foi avaliar a qualidade dos ensaios clínicos aleatórios publicados em terapia intensiva no Brasil. MÉTODOS: Todos os ensaios clínicos aleatórios encontrados através da busca manual na Revista Brasileira de Terapia Intensiva de janeiro de 2001 a março de 2008 foram analisados para avaliar sua descrição através da escala de qualidade. Foi utilizada uma estatística descritiva e intervalo de confiança de 95% para a variável primária. A variável primária foi a qualidade dos ensaios clínicos aleatórios. RESULTADOS: Foram encontrados 185 artigos originais, sendo 14 de ensaios clínicos aleatórios. Apenas um artigo original analisado (7,1% mostrou-se de boa qualidade. Não houve significância estatística entre os dados coletados e os dados mostrados na hipótese desta pesquisa. CONCLUSÃO: Pode-se concluir que na amostra de artigos avaliada 7% dos ensaios clínicos aleatórios em terapia intensiva publicados em uma revista no Brasil são de boa qualidade metodológica.OBJECTIVE: A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. METHODS: All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. RESULTS: Our search found 185 original articles, of which 14 were randomized clinical trials. Only
David Fields PhD
Full Text Available This study compared the growth of healthy infants fed a hypoallergenic 100% whey-based extensively hydrolyzed formula (EHF with Bifidobacterium lactis (test with that of infants fed an extensively hydrolyzed casein formula (control. Formula-fed infants (14 ± 3 days were randomized to test or control groups until 112 days of age. Anthropometrics were assessed at 14, 28, 56, 84, and 112 days, and daily records were kept for 2 days prior to study visits. Serum albumin and plasma amino acids at 84 days were assessed in a subset. A total of 282 infants were randomized (124 test, 158 control. Significantly more infants dropped out of the control (56% as compared with the test (41% group. Mean daily weight gain was significantly higher in the test group compared with the control group (27.95 ± 5.91 vs 25.93 ± 6.12 g/d; P = .027 with the test group reporting significantly fewer stools (2.2 vs 3.6 stools/d; P 3 loose stools/d and a higher incidence of vomiting as compared with the test group. There were no differences in gas, mood, sleep, or serum albumin. Plasma arginine and valine were significantly lower in the test group, whereas leucine and lysine were higher; all values were within normal limits. Significantly more adverse events attributed to the study formula were reported in the control group. The 100% whey-based hypoallergenic EHF containing Bifidobacterium lactis and medium chain triglycerides supported growth of healthy infants. Future studies on the application of this formula in clinically indicated populations are warranted.
Morand, Chrystelle; Coudurier, Nicole; Rolland, Carole; Thoret, Sophie; Legrand, Dominique; Tiberghien, Pierre; Bosson, Jean-Luc
The prevention of presyncopal and syncopal reactions to whole blood donation is important for both the donor's safety and their retention as blood donors. The best strategy to achieve this remains debated. A prospective cluster-randomized trial comparing three hydration modes (500 mL of an isotonic drink, 500 mL of water, just before phlebotomy, or advice to drink [control arm]) coupled or not with light muscle tensing exercises, was carried out in mobile and fixed units of two regional blood centers in southeast France between January and July 2014. The main outcome was the cumulative incidence of presyncope (feeling faint) and syncope (fainting) at the donation site or in the 48 hours after leaving the site. Secondary outcomes were the cumulative incidence of these adverse events during donation, immediately after blood donation, or within 48 hours. Overall, presyncope or syncope occurred in 5.5% of the 4576 donors. Compared to controls, drinking 500 mL (isotonic solution or water) significantly reduced the rate of events (odds ratio [OR], 0.74; 95% confidence interval [CI], 0.55-0.99; p = 0.041) independently of muscle tensing exercise. Muscle tensing exercises significantly reduced syncopal-type reactions during the donation (OR, 0.64; 95% CI, 0.42-0.98; p = 0.041), and an isotonic drink significantly reduced delayed off-site syncopal-type reactions (OR, 0.62; 95% CI, 0.40-0.98; p = 0.040) and tiredness after donation (OR, 0.75; 95% CI, 0.59-0.94; p = 0.014). Drinking 500mL of water or isotonic drink close to phlebotomy is useful in preventing presyncopal or syncopal reactions in blood donors. Isotonic drinks have the advantage of preventing delayed reactions and tiredness after whole blood donation. © 2016 AABB.
Full Text Available The malaria vaccine candidate antigen RTS,S includes parts of the pre-erythrocytic stage circumsporozoite protein fused to the Hepatitis B surface antigen. Two Adjuvant Systems are in development for this vaccine, an oil-in water emulsion--based formulation (AS02 and a formulation based on liposomes (AS01.In this Phase II, double-blind study (NCT00307021, 180 healthy Gabonese children aged 18 months to 4 years were randomized to receive either RTS,S/AS01(E or RTS,S/AS02(D, on a 0-1-2 month vaccination schedule. The children were followed-up daily for six days after each vaccination and monthly for 14 months. Blood samples were collected at 4 time-points. Both vaccines were well tolerated. Safety parameters were distributed similarly between the two groups. Both vaccines elicited a strong specific immune response after Doses 2 and 3 with a ratio of anti-CS GMT titers (AS02(D/AS01(E of 0.88 (95% CI: 0.68-1.15 post-Dose 3. After Doses 2 and 3 of experimental vaccines, anti-CS and anti-HBs antibody GMTs were higher in children who had been previously vaccinated with at least one dose of hepatitis B vaccine compared to those not previously vaccinated.RTS,S/AS01(E proved similarly as well tolerated and immunogenic as RTS,S/AS02(D, completing an essential step in the age de-escalation process within the RTS,S clinical development plan.ClinicalTrials.gov. NCT00307021.
Full Text Available Background and Aim: Results of previous studies have been conflicting on the efficacy of extracorporeal shock wave therapy (ESWT in the treatment of plantar fasciitis. We evaluated the effects of ESWT on plantar fasciitis in terms of ultrasonographic and subjective evaluations. Materials and Methods: In this randomized placebo-controlled trial, patients with plantar fasciitis were assigned to receive ESWT (4000 shock waves/session of 0.2 mJ/mm 2 in 3 sessions at weekly intervals or sham therapy (n = 20 in each group. Outcomes were documented by the ultrasonographic appearance of the aponeurosis and by patients′ pain scores, performed at baseline and 12 weeks after completion of the therapy. Results : The two groups were similar in baseline characteristics. Over the study period, plantar fascia thickness significantly reduced in the ESWT group (4.1 ± 1.3 to 3.6 ± 1.2 mm, P < 0.001, but slightly increased in the sham group (4.1 ± 0.8 to 4.5 ± 0.9 mm, P = 0.03. Both groups showed significant pain improvement over the course of the study (P < 0.001, though pain scores were significantly more reduced in the ESWT than the sham group (-4.2 ± 2.9 vs. -2.7 ± 1.8, P = 0.049. Conclusions: Extracorporeal shock wave therapy contributes to healing and pain reduction in plantar fasciitis and ultrasound imaging is able to depict the morphologic changes related to plantar fasciitis as a result of this therapy.
Yang Won Min
Full Text Available Improving gastric accommodation and gastric emptying is an attractive physiological treatment target in patients with functional dyspepsia (FD. We evaluated the effect of DA-9701, a new drug for FD, on gastric motor function after a meal in healthy volunteers using magnetic resonance imaging (MRI.Forty healthy volunteers were randomly allocated to receive either DA-9701 or placebo. After 5 days of treatment, subjects underwent gastric MRI (60 min before and 15, 30, 45, 60, 90, and 120 min after a liquid test meal. Gastric volume was measured through 3-dimensional reconstruction from MRI data. We analyzed 4 outcome variables including changes in total gastric volume (TGV, proximal TGV, and proximal to distal TGV ratio after a meal and gastric emptying rates after adjusting values at the pre-test meal.Changes in TGV and proximal TGV after a meal did not differ between the DA-9701 and placebo groups (difference between groups -25.9 mL, 95% confidence interval [CI] -54.0 to 2.3 mL, P = 0.070 and -2.9 mL, 95% CI -30.3 to 24.5 mL, P = 0.832, respectively. However, pre-treatment with DA-9701 increased postprandial proximal to distal TGV ratio more than placebo (difference between groups 0.93, 95% CI 0.08 to 1.79, P = 0.034. In addition, pre-treatment with DA-9701 significantly increased gastric emptying as compared with placebo (mean difference between groups 3.41%, 95% CI 0.54% to 6.29%, P = 0.021, by mixed model for repeated measures.Our results suggested that DA-9701 enhances gastric emptying and does not significantly affect gastric accommodation in healthy volunteers. Further studies to confirm whether DA-9701 enhances these gastric motor functions in patients with FD are warranted.ClinicalTrials.gov NCT02091635.
Min, Yang Won; Min, Byung-Hoon; Kim, Seonwoo; Choi, Dongil; Rhee, Poong-Lyul
Improving gastric accommodation and gastric emptying is an attractive physiological treatment target in patients with functional dyspepsia (FD). We evaluated the effect of DA-9701, a new drug for FD, on gastric motor function after a meal in healthy volunteers using magnetic resonance imaging (MRI). Forty healthy volunteers were randomly allocated to receive either DA-9701 or placebo. After 5 days of treatment, subjects underwent gastric MRI (60 min before and 15, 30, 45, 60, 90, and 120 min after a liquid test meal). Gastric volume was measured through 3-dimensional reconstruction from MRI data. We analyzed 4 outcome variables including changes in total gastric volume (TGV), proximal TGV, and proximal to distal TGV ratio after a meal and gastric emptying rates after adjusting values at the pre-test meal. Changes in TGV and proximal TGV after a meal did not differ between the DA-9701 and placebo groups (difference between groups -25.9 mL, 95% confidence interval [CI] -54.0 to 2.3 mL, P = 0.070 and -2.9 mL, 95% CI -30.3 to 24.5 mL, P = 0.832, respectively). However, pre-treatment with DA-9701 increased postprandial proximal to distal TGV ratio more than placebo (difference between groups 0.93, 95% CI 0.08 to 1.79, P = 0.034). In addition, pre-treatment with DA-9701 significantly increased gastric emptying as compared with placebo (mean difference between groups 3.41%, 95% CI 0.54% to 6.29%, P = 0.021, by mixed model for repeated measures). Our results suggested that DA-9701 enhances gastric emptying and does not significantly affect gastric accommodation in healthy volunteers. Further studies to confirm whether DA-9701 enhances these gastric motor functions in patients with FD are warranted. ClinicalTrials.gov NCT02091635.
Erica C. Borresen MPH
Full Text Available Background: Navy beans and rice bran demonstrate efficacy to regulate serum cholesterol in hypercholesterolemic adults; however, the cardiovascular disease (CVD protective properties of these foods in children are unknown and merit investigation. Objective: The objectives were to determine whether cooked navy bean powder (NBP and/or heat-stabilized rice bran (RB supplementation is tolerable, improves dietary fiber intake in children, and modulates lipid profiles. Methods: Children aged 8 to 13 years at risk for CVD due to abnormal lipids were recruited. Elevated cholesterol levels were defined as total cholesterol ≥180 mg/dL and high-density lipoprotein (HDL 100 mg/dL and HDL <60 mg/dL. Participants completed a pilot 4-week, randomized controlled, 4-arm dietary intervention. They consumed study-provided muffins or a smoothie daily that included 0 g NBP or RB (control, 17.5 g NBP, 15 g RB, or a combination 9 g NBP + 8 g RB. Fasting blood was collected at baseline and week 4. Participants also completed 3-day food logs and gastrointestinal health questionnaires. Results: Thirty-eight children completed the trial (n = 9 control, n = 10 NBP, n = 9 RB, and n = 10 NBP + RB groups. Only 3 participants withdrew due to noncompliance of required food consumption. Participants in the intervention groups significantly increased intake of NBP and RB at week 4 (p≤.01. The NBP and NBP + RB groups increased total fiber intake from baseline to week 4 (p=.02 and p=<.01, respectively. HDL-cholesterol was higher in NBP-group participants compared to control at week 4 (P = .02. Conclusion: Increasing NBP and/or RB intake is tolerable for children, and our findings suggest higher daily intakes are needed for a longer duration to induce favorable changes across multiple serum lipid parameters.
Christine L Mattson
Full Text Available Three randomized controlled trials (RCTs have confirmed that male circumcision (MC significantly reduces acquisition of HIV-1 infection among men. The objective of this study was to perform a comprehensive, prospective evaluation of risk compensation, comparing circumcised versus uncircumcised controls in a sample of RCT participants.Between March 2004 and September 2005, we systematically recruited men enrolled in a RCT of MC in Kenya. Detailed sexual histories were taken using a modified Timeline Followback approach at baseline, 6, and 12 months. Participants provided permission to obtain circumcision status and laboratory results from the RCT. We evaluated circumcised and uncircumcised men's sexual behavior using an 18-item risk propensity score and acquisition of incident infections of gonorrhea, chlamydia, and trichomoniasis. Of 1780 eligible RCT participants, 1319 enrolled (response rate = 74%. At the baseline RCT visit, men who enrolled in the sub-study reported the same sexual behaviors as men who did not. We found a significant reduction in sexual risk behavior among both circumcised and uncircumcised men from baseline to 6 (p<0.01 and 12 (p = 0.05 months post-enrollment. Longitudinal analyses indicated no statistically significant differences between sexual risk propensity scores or in incident infections of gonorrhea, chlamydia, and trichomoniasis between circumcised and uncircumcised men. These results are based on the most comprehensive analysis of risk compensation yet done.In the context of a RCT, circumcision did not result in increased HIV risk behavior. Continued monitoring and evaluation of risk compensation associated with circumcision is needed as evidence supporting its' efficacy is disseminated and MC is widely promoted for HIV prevention.
Dussel, Veronica; Orellana, Liliana; Soto, Natalie; Chen, Kun; Ullrich, Christina; Kang, Tammy I; Geyer, Jeffrey R; Feudtner, Chris; Wolfe, Joanne
Pediatric palliative care randomized controlled trials (PPC-RCTs) are uncommon. To evaluate the feasibility of conducting a PPC-RCT in pediatric cancer patients. This was a cohort study embedded in the Pediatric Quality of Life and Evaluation of Symptoms Technology Study (NCT01838564). This multicenter PPC-RCT evaluated an electronic patient-reported outcomes system. Children aged two years and older, with advanced cancer, and potentially eligible for the study were included. Outcomes included: pre-inclusion attrition (patients not approached, refusals); post-inclusion attrition (drop-out, elimination, death, and intermittent attrition (IA; missing surveys) over nine months of follow-up); child/teenager self-report rates; and, reasons to enroll/participate. Over five years, of the 339 identified patients, 231 were eligible (in 22, we could not verify eligibility); 84 eligible patients were not approached and 43 declined participation. Patients not approached were more likely to die or have brain tumors. We enrolled 104 patients. Average enrollment rate was one patient per site per month; shortening follow-up from nine to three months (with optional re-enrollment) increased recruitment by 20%. A total of 87 patients completed the study (24 died) and 17 dropped out. Median IA was 41% in the first 20 weeks of follow-up and more than 60% in the eight weeks preceding death. Child/teenager self-report was 94%. Helping others, low burden procedures, incentives, and staff attitude were frequent reasons to enroll/participate. A PPC-RCT in children with advanced cancer was feasible, post-inclusion retention adequate; many families participated for altruistic reasons. Strategies that may further PPC-RCT feasibility include: increasing target population through large multicenter studies, approaching sicker patients, preventing exclusion of certain patient groups, and improving data collection at end of life. Copyright © 2015 American Academy of Hospice and Palliative Medicine
Miles, Peter; Fisher, Elizabeth; Pandis, Nikolaos
The purpose of this 2-arm parallel trial was to assess the effect of the AcceleDent Aura appliance (OrthoAccel Technologies, Houston, Tex) on the rate of maxillary premolar extraction space closure in adolescent patients. Forty Class II adolescents treated with full fixed appliances and maxillary premolar extractions participated in this randomized clinical trial. They were recruited in a private practice and treated by 1 clinician. Randomization was accomplished in blocks of 10 patients assigned to either a no-appliance group or the AcceleDent Aura appliance group with the allocations concealed in opaque, sealed envelopes. Both the operator and the outcome assessor were blinded; however, it was not feasible to blind the patients. Models were taken of the maxillary arch at the start of space closure and just before complete space closure. The space was measured parallel to the occlusal plane from the cusp tips of the teeth mesial and distal to the extraction spaces. There was no clinically (0.05 mm per month; 95% confidence interval [CI], -0.24, 0.34) or statistically significant difference in the rate of space closure (P = 0.74). In both the univariable and multivariable analyses, the mean rate of tooth movement was slower by 0.13 mm per month (95% CI, -.26, .005) on the left side compared with the right side, but this was not statistically significant (P = 0.06). The AcceleDent Aura appliance had no effect on the rate of maxillary premolar extraction space closure. Only a few participants were considered to be good compliers with the appliance. However, the rate of space closure in the good compliers was similar to the overall group and did not appear to influence the result. This trial was not registered. The protocol was not published before trial commencement. Copyright © 2017 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.
Manfredini, Fabio; Mallamaci, Francesca; D'Arrigo, Graziella; Baggetta, Rossella; Bolignano, Davide; Torino, Claudia; Lamberti, Nicola; Bertoli, Silvio; Ciurlino, Daniele; Rocca-Rey, Lisa; Barillà, Antonio; Battaglia, Yuri; Rapanà, Renato Mario; Zuccalà, Alessandro; Bonanno, Graziella; Fatuzzo, Pasquale; Rapisarda, Francesco; Rastelli, Stefania; Fabrizi, Fabrizio; Messa, Piergiorgio; De Paola, Luciano; Lombardi, Luigi; Cupisti, Adamasco; Fuiano, Giorgio; Lucisano, Gaetano; Summaria, Chiara; Felisatti, Michele; Pozzato, Enrico; Malagoni, Anna Maria; Castellino, Pietro; Aucella, Filippo; Abd ElHafeez, Samar; Provenzano, Pasquale Fabio; Tripepi, Giovanni; Catizone, Luigi; Zoccali, Carmine
Previous studies have suggested the benefits of physical exercise for patients on dialysis. We conducted the Exercise Introduction to Enhance Performance in Dialysis trial, a 6-month randomized, multicenter trial to test whether a simple, personalized walking exercise program at home, managed by dialysis staff, improves functional status in adult patients on dialysis. The main study outcomes included change in physical performance at 6 months, assessed by the 6-minute walking test and the five times sit-to-stand test, and in quality of life, assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. We randomized 296 patients to normal physical activity (control; n=145) or walking exercise (n=151); 227 patients (exercise n=104; control n=123) repeated the 6-month evaluations. The distance covered during the 6-minute walking test improved in the exercise group (mean distance±SD: baseline, 328±96 m; 6 months, 367±113 m) but not in the control group (baseline, 321±107 m; 6 months, 324±116 m; Pquality of social interaction score (P=0.01) in the kidney disease component of the KDQOL-SF improved significantly in the exercise arm compared with the control arm. Hence, a simple, personalized, home-based, low-intensity exercise program managed by dialysis staff may improve physical performance and quality of life in patients on dialysis. Copyright © 2017 by the American Society of Nephrology.
Ferreira,Giovanni E.; Barreto,Rodrigo G. P.; Caroline C. Robinson; Rodrigo D. M. Plentz; Silva, Marcelo F.
ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Ri...
Randomized evaluation of live attenuated vs. inactivated influenza vaccines in schools (RELATIVES) cluster randomized trial: Pilot results from a household surveillance study to assess direct and indirect protection from influenza vaccination.
Kwong, Jeffrey C; Pereira, Jennifer A; Quach, Susan; Pellizzari, Rosana; Dusome, Edwina; Russell, Margaret L; Hamid, Jemila S; Feinberg, Yael; Winter, Anne-Luise; Gubbay, Jonathan B; Sirtonski, Brittany; Moher, Deanna; Sider, Doug; Finkelstein, Michael; Loeb, Mark
Children are key drivers of influenza transmission. Vaccinating school age children decreases influenza in the community. To pilot-test the methods for a future trial to compare the direct and indirect benefits of inactivated influenza vaccine (IIV) vs. live attenuated influenza vaccine (LAIV) in preventing influenza infection. During the 2013-14 influenza vaccination campaign, we piloted an open-label cluster randomized trial involving 10 elementary schools in Peterborough, Ontario, Canada. We randomized schools on a 1:1 basis to have students receive IIV or LAIV. We invited a subset of vaccinated students and their households to participate in a surveillance sub-study, which involved completing daily symptom diaries during influenza season and collecting mid-turbinate swabs from symptomatic individuals to detect influenza infection. The main outcome measure was confirmed influenza infection using a real-time reverse transcriptase polymerase chain reaction (PCR) assay. One hundred and nineteen households (166 students and 293 household members) participated. During 15 weeks of surveillance, we detected 22 episodes of PCR-confirmed influenza (21 influenza A/H1N1 and 1 influenza B). The incidence of influenza per 1000 person-days was 1.24 (95% CI, 0.40-2.89) for IIV-vaccinated students, compared to 0.13 (95% CI, 0.003-0.72) for LAIV-vaccinated students; the incidence rate ratio was 0.10 (95% CI, 0.002-0.94). Similarly, the incidence of influenza per 1000 person-days was 1.33 (95% CI, 0.64-2.44) for IIV household members, compared to 0.47 (95% CI, 0.17-1.03) for LAIV household members; the incidence rate ratio was 0.36 (95% CI, 0.11-1.08). The overall incidence rate ratio (combining students and household members) was 0.27 (95% CI, 0.09-0.69). Household surveillance involving participant monitoring and reporting of symptoms and self-collection of mid-turbinate swabs is feasible. A larger study is required to validate the suggestion that vaccinating children with LAIV
May 20, 2004 ... cal trials were found to be eligible for recruitment to those studies.1 Looking at this issue from another perspective, fewer than fifteen percent of unselected patients attending a psychi- atric outpatient department clinic met eligibility criteria for inclusion into clinical trials.2,3 Results from clinical trials are.
Tappin David M
Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an
Schwendicke, Falk; Göstemeyer, Gerd; Gluud, Christian
After removal of dentine caries lesions, cavity lining has been advocated. Non-clinical data support this approach, but clinical data are sparse and ambiguous. We aimed at evaluating the benefits and harms of cavity lining using meta-analysis and Trial Sequential Analysis. We included randomized clinical trials comparing restorations without versus with cavity lining for treating primary caries lesions. Only trials reporting failure (defined as need to re-retreat) after ≥1 year follow-up were included. Trial selection, data extraction, and risk of bias assessment were conducted independently by two reviewers. We conducted random-effects intention-to-treat and per-protocol meta-analyses, and Trial Sequential Analysis to control for random errors. Electronic databases (PubMed, Embase, CENTRAL) were systematically screened, and hand searches and cross-referencing performed. From 128 studies, three randomized trials (89/130 patients or teeth), all treating primary teeth, were included. The trials had high risk of bias. All trials compared no lining versus calcium hydroxide lining after selective caries removal followed by adhesive restoration. Follow-up was 36 to 53 months. Restoring the cavity without lining did not significantly affect the risk of failure (intention-to-treat relative risk (RR) (95% confidence interval) 0.71 (0.49-1.04), per-protocol RR 0.52 (0.24-1.10). According to Trial Sequential Analysis, no firm evidence was reached. The quality of evidence was very low. Strong recommendations for using cavity liners are unsubstantiated, but firm evidence for omitting lining is also unavailable. Our findings apply only to primary teeth and calcium hydroxide liner. Whilst lining is frequently performed in dental practice, very few randomized clinical trials investigated this issue. The three trials included in this review treated deciduous teeth and did not find lining with calcium hydroxide beneficial. Lining is not supported by sufficient clinical evidence
Wang, Xin; Wanyan, Pingping; Wang, Jian Min; Tian, Jin Hui; Hu, Long; Shen, Xi Ping; Yang, Ke Hu
Gouty knee arthritis refers to a form of inflammatory diseases caused by deposits of needle-like crystals of uric acid in knee joint. The aim of this study was to assess the efficacy and safety of arthroscopic debridement in combination with oral medication versus oral medication alone for the treatment of gouty knee arthritis. A total of 60 patients with gouty knee arthritis were randomized to receive either arthroscopic surgery in combination with oral medication or oral medication alone. Efficacy was assessed with the angle of motion, functions, and visual analog scale (VAS). These indices were measured prior to treatment and at 2, 4, 12, 24, and 48 weeks posttreatment. Surgery- and medication-related complications were observed. Significant differences in flexion and extension of the knee joint, lymphoma scores, and VAS were detected between the two groups at 2, 4, and 12 weeks posttreatment (P 0.05) . Significant differences in these indices were detected at different time points in each group (P 0.05). Arthroscopic surgery in combination with oral medication is superior to single oral medication in the flexion and extension of the knee joint, lymphoma scores, and pain relief (VAS) before 24 weeks, although no statistical differences were detected in the efficacy after 24 weeks, and in medication-related safety between the two groups. Although arthroscopic debridement cannot replace systemic uric acid-lowering treatments such as medication and dietary control, it is still an effective approach.
EFFECTIVENESS OF DIALECTICAL BEHAVIOR THERAPY VERSUS COLLABORATIVE ASSESSMENT AND MANAGEMENT OF SUICIDALITY TREATMENT FOR REDUCTION OF SELF-HARM IN ADULTS WITH BORDERLINE PERSONALITY TRAITS AND DISORDER-A RANDOMIZED OBSERVER-BLINDED CLINICAL TRIAL.
Andreasson, Kate; Krogh, Jesper; Wenneberg, Christina; Jessen, Helle K L; Krakauer, Kristine; Gluud, Christian; Thomsen, Rasmus R; Randers, Lasse; Nordentoft, Merete
Many psychological treatments have shown effect on reducing self-harm in adults with borderline personality disorder. There is a need of brief psychotherapeutical treatment alternative for suicide prevention in specialized outpatient clinics. The DiaS trial was designed as a pragmatic single-center, two-armed, parallel-group observer-blinded, randomized clinical superiority trial. The participants had at least two criteria from the borderline personality disorder diagnosis and a recent suicide attempt (within a month). The participants were offered 16 weeks of dialectical behavior therapy (DBT) versus up to 16 weeks of collaborative assessment and management of suicidality (CAMS) treatment. The primary composite outcome was the number of participants with a new self-harm (nonsuicidal self-injury [NSSI] or suicide attempt) at week 28 from baseline. Other exploratory outcomes were: severity of borderline symptoms, depressive symptoms, hopelessness, suicide ideation, and self-esteem. At 28 weeks, the number of participants with new self-harm in the DBT group was 21 of 57 (36.8%) versus 12 of 51 (23.5%) in the CAMS treatment (OR: 1.90; 95% CI: 0.80-4.40; P = .14). When assessing the effect of DBT versus CAMS treatment on the individual components of the primary outcome, we observed no significant differences in the number of NSSI (OR: 1.60; 95% CI: 0.70-3.90; P = .31) or number of attempted suicides (OR: 2.24; 95% CI: 0.80-7.50; P = .12). In adults with borderline personality traits and disorder and a recent suicide attempt, DBT does not seem superior compared with CAMS for reduction of number of self-harm or suicide attempts. However, further randomized clinical trials may be needed. © 2016 Wiley Periodicals, Inc.
Study protocol: a cluster randomized controlled trial to assess the effectiveness of a multi-pronged behavioural intervention to improve use of personal protective equipment among migrant workers exposed to organic solvents in small and medium-sized enterprises
Full Text Available Abstract Background In China, most of migrant workers work in the small and medium-sized enterprises (SMEs and are a vulnerable group for occupational health. Migrant workers are at increased risk of occupational health risks due to poor occupational health behaviours such as the low use of personal protective equipment (PPE. However, there is a lack of solid evidence regarding how to improve the use of PPE among migrant workers in SMEs. The current study will assess the effectiveness of a multi-pronged behavioural intervention designed to promote PPE utilization among migrant workers exposed to organic solvents in SMEs. Methods/Design This is a single blind, three-arm cluster randomized trial with 60 SMEs equally randomized to receive a top-down intervention (i.e. general health education and mHealth intervention provided by researchers or a comprehensive intervention (which includes both top-down intervention and peer education or a control condition (participants will not receive the intervention, but study measures will be obtained. Interventions will be conducted at the SMEs level for 6 months and all eligible migrant workers in these SMEs will be enrolled into the trial. The primary outcome is effective use of PPE during the last week. The secondary outcomes are occupational health knowledge and attitude and participation in occupational health check-up. Data will be collected and assessed at baseline; 3 months post baseline and the end of the intervention. Discussion This theory- and evidence based intervention will contribute to the limited evidence of behaviour change intervention in improving PPE utilization of migrant workers in SMEs, and provide timely evidence for the development of basic occupational health services in China and elsewhere with similar industrialization contexts. Trial registration ChiCTR-IOR-15006929 . Registered on 16 August 2015.
Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial.
Al-Sibaie, Salma; Hajeer, Mohammad Y
No randomized controlled trial has tried to compare treatment outcomes between the sliding en-masse retraction of upper anterior teeth supported by mini-implants and the two-step sliding retraction technique employing conventional anchorage devices. To evaluate skeletal, dental, and soft tissue changes following anterior teeth retraction. Parallel-groups randomized controlled trial on patients with class II division 1 malocclusion treated at the University of Al-Baath Dental School in Hamah, Syria between July 2011 and May 2013. One hundred and thirty-three patients with an upper dentoalveolar protrusion were evaluated and 80 patients fulfilled the inclusion criteria. Randomization was performed using computer-generated tables; allocation was concealed using sequentially numbered opaque and sealed envelopes. Fifty-six participants were analysed (mean age 22.34 ± 4.56 years). They were randomly distributed into two groups with 28 patients in each group (1:1 allocation ratio). Following first premolar extraction, space closure was accomplished using either the en-masse technique with mini-implants or the two-step technique with transpalatal arches (TPAs). The antero-posterior displacements of upper incisal edges and upper first molars were measured on lateral cephalograms at three assessment times. Assessor blinding was employed. A bodily retraction (-4.42 mm; P upper anterior teeth was achieved in the mini-implants group, whereas upper anterior teeth retraction was achieved by controlled palatal tipping in the TPA group. When retracting anterior teeth in patients with moderate to severe protrusion, the en-masse retraction based on mini-implants anchorage gave superior results compared to the two-step retraction based on conventional anchorage in terms of speed, dental changes, anchorage loss, and aesthetic outcomes.
Sim, I; McDonald, K M; Lavori, P W; Norbutas, C M; Hlatky, M A
Some randomized clinical trials of amiodarone therapy to prevent sudden cardiac death have had positive results and others have had negative results, but all were relatively small. This meta-analysis aimed to pool all trials to assess the effect of amiodarone on mortality and the impact of differences in patient population and study design on trial outcomes. Fifteen randomized trials were identified, and outcome measures were combined by use of a random effects model. The effect of patient population and study design on total mortality was assessed by use of a hierarchical Bayes model. Amiodarone reduced total mortality by 19% (confidence limits, 6% to 31%; Ptrials enrolling patients after myocardial infarction (21%), with left ventricular dysfunction (22%), and after cardiac arrest (25%). There was a trend toward greater risk reduction in trials requiring evidence of ventricular ectopy (25%) than in the remaining trials (10%). The trials using placebo controls had considerably less risk reduction (10%) than trials with active controls (27%) or usual care controls (42%, posterior odds Amiodarone reduced total mortality by 10% to 19% in patients at risk of sudden cardiac death. Amiodarone reduced risk similarly in patients after myocardial infarction, with heart failure, or with clinically evident arrhythmia. The apparent inconsistencies among results of randomized trials appear to be due to small sample sizes and the type of control group used, not the type of patient enrolled.
reported and published, 3 structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4 potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5 in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial. Keywords: randomized clinical trials, RCT, validity, study design, CONSORT
Önol, Fikret Fatih; Guzel, Rasim; Tahra, Ahmet; Kaya, Cevdet; Boylu, Ugur
We compared the long-term success of desmopressin sublingual lyophilisate formulation and enuretic alarm therapy in children with primary monosymptomatic nocturnal enuresis, and determined predictive factors for treatment success. A total of 142 children with primary monosymptomatic nocturnal enuresis were randomized to receive treatment consisting of desmopressin or enuretic alarm for 6 months. Treatment compliance and response were reviewed monthly in each patient using a 30-day bed-wetting diary. Outcomes were assessed according to International Children's Continence Society criteria, and success rates at 6 and 12 months were compared for desmopressin and enuretic alarm. Additional intention to treat analyses were performed, considering cases with missing data as failures. Possible demographic factors predicting success were investigated by logistic regression analysis. Overall 4 children (5.2%) in the desmopressin group and 20 (30.7%) in the enuretic alarm group withdrew after randomization. Based on patients who completed 6 months of treatment, success (more than 90% reduction in wet nights per month) was achieved in 76.8% and 61.8% of children in the desmopressin and enuretic alarm groups, respectively. At 12 months 77.8% of those receiving desmopressin and 75% of those treated with enuretic alarm had success. However, long-term success rate was significantly higher with desmopressin (68.8% vs 46.2%) if intention to treat population was considered. Multivariate analysis revealed treatment group, severity of enuresis and monthly income as independent predictors of cure at 6 months. In compliant patients desmopressin lyophilisate and enuretic alarm provided equivalent success at the end of treatment and after extended followup. Alarm therapy had a high rate of early withdrawal from therapy and consequently lower rates of success on intention to treat analyses. Severe enuresis (more than 5 wet nights weekly) is an important predictive factor for cure after first
Lubans, David R; Smith, Jordan J; Plotnikoff, Ronald C; Dally, Kerry A; Okely, Anthony D; Salmon, Jo; Morgan, Philip J
Obesity prevention interventions targeting 'at-risk' adolescents are urgently needed. The aim of this study is to evaluate the sustained impact of the 'Active Teen Leaders Avoiding Screen-time' (ATLAS) obesity prevention program. Cluster RCT in 14 secondary schools in low-income communities of New South Wales, Australia. Participants were 361 adolescent boys (aged 12-14 years) 'at risk' of obesity. The intervention was based on Self-Determination Theory and Social Cognitive Theory and involved: professional development, fitness equipment for schools, teacher-delivered physical activity sessions, lunch-time activity sessions, researcher-led seminars, a smartphone application, and parental strategies. Assessments for the primary (body mass index [BMI], waist circumference) and secondary outcomes were conducted at baseline, 8- (post-intervention) and 18-months (follow-up). Analyses followed the intention-to-treat principle using linear mixed models. After 18-months, there were no intervention effects for BMI or waist circumference. Sustained effects were found for screen-time, resistance training skill competency, and motivational regulations for school sport. There were no clinically meaningful intervention effects for the adiposity outcomes. However, the intervention resulted in sustained effects for secondary outcomes. Interventions that more intensively target the home environment, as well as other socio-ecological determinants of obesity may be needed to prevent unhealthy weight gain in adolescents from low-income communities. Australian Clinical Trial Registry ACTRN12612000978864.
Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT).
Kingston, Dawn; Austin, Marie-Paule; Hegadoren, Kathy; McDonald, Sheila; Lasiuk, Gerri; McDonald, Sarah; Heaman, Maureen; Biringer, Anne; Sword, Wendy; Giallo, Rebecca; Patel, Tejal; Lane-Smith, Marie; van Zanten, Sander Veldhuyzen
Stress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being. The purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment, referral, and cognitive behavior therapy (CBT) for pregnant women compared to usual prenatal care (no formal screening or specialized care). The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks postrandomization. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. Pregnant women are eligible if they: 1) are prenatal mental healthcare and the use of highly accessible computer-based psychosocial assessment and CBT on maternal, infant, and family-based outcomes. ClinicalTrials.gov Identifier: NCT01901796.
Callahan Christopher M
to subjects treated in the control group. Outcomes The primary outcome is the Alzheimer’s Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects’ physical performance scales are completed in the subject’s home. Randomization Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio. Blinding Single blinded. Research assistants completing the outcome assessments were blinded to the subjects’ treatment group. Trial status Ongoing ClinicalTrial.Gov identifier NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011
Rappaport, Aviva I; Whitfield, Kyly C; Chapman, Gwen E; Yada, Rickey Y; Kheang, Khin Meng; Louise, Jennie; Summerlee, Alastair J; Armstrong, Gavin R; Green, Timothy J
Background: Anemia affects 45% of women of childbearing age in Cambodia. Iron supplementation is recommended in populations in which anemia prevalence is high. However, there are issues of cost, distribution, and adherence. A potential alternative is a reusable fish-shaped iron ingot, which, when added to the cooking pot, leaches iron into the fluid in which it is prepared.Objective: We sought to determine whether there was a difference in hemoglobin concentrations in rural Cambodian anemic women (aged 18-49 y) who cooked with the iron ingot or consumed a daily iron supplement compared with a control after 1 y.Design: In Preah Vihear, 340 women with mild or moderate anemia were randomly assigned to 1) an iron-ingot group, 2) an iron-supplement (18 mg/d) group, or 3) a nonplacebo control group. A venous blood sample was taken at baseline and at 6 and 12 mo. Blood was analyzed for hemoglobin, serum ferritin, and serum transferrin receptor. Hemoglobin electrophoresis was used to detect structural hemoglobin variants.Results: Anemia prevalence was 44% with the use of a portable hemoglobinometer during screening. At baseline, prevalence of iron deficiency was 9% on the basis of a low serum ferritin concentration. There was no significant difference in mean hemoglobin concentrations between the iron-ingot group (115 g/L; 95% CI: 113, 118 g/L; P = 0.850) or iron-supplement group (115 g/L; 95% CI: 113, 117 g/L; P = 0.998) compared with the control group (115 g/L; 95% CI: 113, 117 g/L) at 12 mo. Serum ferritin was significantly higher in the iron-supplement group (73 μg/L; 95% CI: 64, 82 μg/L; P = 0.002) than in the control group at 6 mo; however, this significance was not maintained at 12 mo (73 μg/L; 95% CI: 58, 91 μg/L; P = 0.176).Conclusions: Neither the iron ingot nor iron supplements increased hemoglobin concentrations in this population at 6 or 12 mo. We do not recommend the use of the fish-shaped iron ingot in Cambodia or in countries where the prevalence of
Niël-Weise, B S; Wille, J C; van den Broek, P J
To determine whether certain hair removal policies are better than others to prevent surgical-site infections in patients undergoing clean surgery. Publications were retrieved by a systematic search of Medline, the Cochrane Library, and EMBASE up to February 2005. Additionally, the reference lists of all identified trials were examined. All randomized trials, quasi-randomized trials, and systematic reviews or meta-analyses of randomized or quasi-randomized trials comparing hair removal policies in clean surgery were selected. Trials involving patients undergoing cranial neurosurgery were excluded. Two reviewers independently assessed trial quality and extracted data. Disagreements were resolved by discussion with a third reviewer. Data from the original publications were used to calculate the relative risk or risk difference of surgical-site infection. Data for similar outcomes were combined in the analysis, where appropriate, with the use of a random effects model. Four trials were included in the review. No eligible systematic review or meta-analysis of randomized or quasi-randomized trials was found. The quality of the trials and how they were reported were generally unsatisfactory. Evidence regarding whether preoperative hair removal has any effect was inconclusive. When hair removal was considered necessary, evidence about the best time for removal was inconclusive. There was some evidence that hair removal by clipper is superior to removal by razor. Because of insufficient evidence as a basis for recommendations, the practical consequences for ward management were essential when the Dutch Working Party on Infection Prevention formulated its recommendations for hair removal policies. Large randomized, controlled trials are needed to determine the optimal policy for preoperative hair removal.
Tawil, Isaac; Brown, Lawrence H; Comfort, David; Crandall, Cameron S; West, Sonlee D; Rollstin, Amber D; Dettmer, Todd S; Malkoff, Marc D; Marinaro, Jonathan
To evaluate if a family presence educational intervention during brain death evaluation improves understanding of brain death without affecting psychological distress. Randomized controlled trial. Four ICUs at an academic tertiary care center. Immediate family members of patients suspected to have suffered brain death. Subjects were group randomized to presence or absence at bedside throughout the brain death evaluation with a trained chaperone. All randomized subjects were administered a validated "understanding brain death" survey before and after the intervention. Subjects were assessed for psychological well-being between 30 and 90 days after the intervention. Follow-up assessment of psychological well-being was performed using the Impact of Event Scale and General Health Questionnaire. Brain death understanding, Impact of Event Scale, and General Health Questionnaire scores were analyzed using Wilcoxon nonparametric tests. Analyses were adjusted for within family correlation. Fifty-eight family members of 17 patients undergoing brain death evaluation were enrolled: 38 family members were present for 11 brain death evaluations and 20 family members were absent for six brain death evaluations. Baseline understanding scores were similar between groups (median 3.0 [presence group] vs 2.5 [control], p = 0.482). Scores increased by a median of 2 (interquartile range, 1-2) if present versus 0 (interquartile range, 0-0) if absent (p Family presence during brain death evaluation improves understanding of brain death with no apparent adverse impact on psychological well-being. Family presence during brain death evaluation is feasible and safe.
Durmus, Dilek; Alayli, Gamze; Bayrak, Ilkay Koray; Canturk, Ferhan
Osteoarthritis (OA) is a chronic disease characterized by the focal deterioration and abrasion of articular cartilage. The goals of therapy are preserving normal joint function, relieving pain and improving quality of life (QOL). This study is performed to investigate whether glocosamine sulfate and exercise could both delay joint structure degradation evaluated with magnetic resonance imaging (MRI) and improve symptoms in a short time period. Thirty-nine women with the diagnosis of knee OA were enrolled in the study. Patients were randomized into two groups. Group I (n=20) received an exercise program, while group II (n=19) received glucosamin sulphate (1500 mg/day) in addition to the exercise therapy. Both groups were treated for 12 weeks. The patients were evaluated before and after the treatment regarding pain, disability, functional performance, muscle strength, QOL, depression and MRI findings (cartilage volume, medial and lateral cartilage thickness). Both groups showed significant improvements in pain, disability, functional performance, QOL and depression with no statistically significant difference between the groups after the therapy. While there were significant improvements for all MRI parameters expect right knee cartilage volume and lateral cartilage thickness in two groups, statistically significant differences could not be demonstrated between the groups after the therapy. We found no additional effect of glucosamine in delaying the radiological progression and relieving the symptoms of OA. We also demonstrated that exercise alone was adequate to prevent structural changes and cartilage loss of the knee joint as assessed by MRI.
Helmerhorst Frans M
Full Text Available Abstract Background The usefulness of hysterosalpingography (HSG as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records. Results Out of 759 women, a total of 127 (17% agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%. Other reasons were inattentive clinicians (3% and patient-associated reasons (24%. Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure. Conclusion Almost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial.
Jenner, JA; Nienhuis, FJ; Wiersma, D; van de Willige, G
Improvements in psychopathology, subjective burden, and coping with voices after hallucination focused integrative treatment (HIT) were studied in chronic schizophrenic patients with persistent (> 10 years), drug-refractory auditory hallucinations. In a randomized controlled trial, routine care was
Pedersen, Allan Gorm; Petersen, O B; Wara, P
BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...
Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial. CS Deshpande, A Rakshani, R Nagarathna, TS Ganpat, A Kurpad, R Maskar, DC Sudheer, HR Nagendra, R Abbas, N Raghuram, K Anura, M Rita, NH Ramarao ...
Field, JK; Klaveren, R; Pedersen, JH
Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects...
Carson, Valerie; Salmon, Jo; Arundell, Lauren; Ridgers, Nicola D; Cerin, Ester; Brown, Helen; Hesketh, Kylie D; Ball, Kylie; Chinapaw, Mai; Yildirim, Mine; Daly, Robin M; Dunstan, David W; Crawford, David
The optimal targets and strategies for effectively reducing sedentary behavior among young people are unknown. Intervention research that explores changes in mediated effects as well as in outcome behaviors is needed to help inform more effective interventions. Therefore, the purpose of this study was to examine the mid-intervention mediating effects on children's objectively assessed classroom and total weekday sedentary time in the Transform-Us! intervention. The results are based on 293 children, aged 7- to 9-years-old at baseline, from 20 schools in Melbourne, Australia. Each school was randomly allocated to one of four groups, which targeted reducing sedentary time in the school and family settings (SB; n = 74), increasing or maintaining moderate- to vigorous-intensity physical activity in the school and family settings (PA; n = 75), combined SB and PA (SB + PA; n = 80), or the current practice control (C; n = 64). Baseline and mid-intervention data (5-9 months) were collected in 2010 and analyzed in 2012. Classroom and total weekday sedentary time was objectively assessed using ActiGraph accelerometers. The hypothesized mediators including, child enjoyment, parent and teacher outcome expectancies, and child perceived access to standing opportunities in the classroom environment, were assessed by questionnaire. The SB + PA group spent 13.3 min/day less in weekday sedentary time at mid-intervention compared to the control group. At mid-intervention, children in the SB group had higher enjoyment of standing in class (0.9 units; 5-unit scale) and all intervention groups had more positive perceptions of access to standing opportunities in the classroom environment (0.3-0.4 units; 3-unit scale), compared to the control group. However, none of the hypothesized mediator variables had an effect on sedentary time; thus, no mediating effects were observed. While beneficial intervention effects were observed on some hypothesized mediating
Thabane, Alex; Dennis, Brittany B; Gajic-Veljanoski, Olga; Paul, James; Thabane, Lehana
Stepped wedge design (SWD) is a cluster randomized controlled trial (RCT) design that sequentially rolls out intervention to all clusters at varying time points. Being a relatively new design method, reporting quality has yet to be explored, and this review will seek to fill this gap in knowledge. The objectives of this review are: 1) to assess the quality of SWD trial reports based on the CONSORT guidelines or CONSORT extension to cluster RCTs; 2) to assess the completeness of reporting of SWD trial abstracts using the CONSORT extension for abstracts; 3) to assess the reporting of sample size details in SWD trial reports or protocols; 4) to assess the completeness of reporting of SWD trial protocols according to SPIRIT guidelines; 5) to assess the consistency between the trial registration information and final SWD trial reports; and 6) to assess the consistency of what is reported in the abstracts and main text of the SWD trial reports. We will also explore factors that are associated with the completeness of reporting. We will search MEDLINE, EMBASE, Web of Science, CINAHL, and PsycINFO for all randomized controlled trials utilizing SWD. Details from eligible papers will be extracted in duplicate. Demographic statistics obtained from the data extraction will be analyzed to answer the primary objectives pertaining to the reporting quality of several aspects of a published paper, as well as to explore possible temporal trends and consistency between abstracts, trial registration information, and final published articles. Findings from this review will establish the reporting quality of SWD trials and inform academics and clinicians on their completeness and consistency. Results of this review will influence future trials and improve the overall quality and reporting of SWD trials.
Reveiz, Ludovic; Bonfill, Xavier; Glujovsky, Demian; Pinzon, Carlos E; Asenjo-Lobos, Claudia; Cortes, Marcela; Canon, Martin; Bardach, Ariel; Comandé, Daniel; Cardona, Andrés F
To determine the prevalence of trial registration in randomized controlled trials (RCTs) published in 2010 (PUBMED/LILACS) from Latin America and the Caribbean's (LAC) and to compare methodological characteristics between registered and nonregistered RCTs. A search for detecting RCTs in which at least the first/contact author had a LAC's affiliation was made. We determined if RCTs were registered in the International Clinical Trial Registry Platform (ICTRP). Data were independently extracted by two authors. The risk of bias (RoB) was assessed in all registered RCTs (n=89) and in a sample of nonregistered RCTs (n=237). The search identified 1,695 references; 526 RCTs from 19 countries were included. 16.9% (89/526) of RCTs were registered in the ICTRP; however, only 21 (4.0%) were prospectively registered. A significant difference was found in the overall assessment of the RoB between registered and nonregistered RCTs. Overall, registered RCTs were multinational, had larger sample size and longer follow-up, and reported more frequently information on funding, conflict of interests, and ethic issues. No significant differences were found when analyzing prospectively registered RCTs. This study shows that trial registration rates are still low in LAC and the quality of reporting needs to be improved. Copyright Â© 2012 Elsevier Inc. All rights reserved.
Giugliano, Robert P; Mach, François; Zavitz, Kenton; Kurtz, Christopher; Im, Kyungah; Kanevsky, Estella; Schneider, Jingjing; Wang, Huei; Keech, Anthony; Pedersen, Terje R; Sabatine, Marc S; Sever, Peter S; Robinson, Jennifer G; Honarpour, Narimon; Wasserman, Scott M; Ott, Brian R
Background Findings from clinical trials of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors have led to concern that these drugs or the low levels of low-density lipoprotein (LDL) cholesterol that result from their use are associated with cognitive deficits. Methods In a subgroup of patients from a randomized, placebo-controlled trial of evolocumab added to statin therapy, we prospectively assessed cognitive function using the Cambridge Neuropsychological Test Automated Battery. The primary end point was the score on the spatial working memory strategy index of executive function (scores range from 4 to 28, with lower scores indicating a more efficient use of strategy and planning). Secondary end points were the scores for working memory (scores range from 0 to 279, with lower scores indicating fewer errors), episodic memory (scores range from 0 to 70, with lower scores indicating fewer errors), and psychomotor speed (scores range from 100 to 5100 msec, with faster times representing better performance). Assessments of cognitive function were performed at baseline, week 24, yearly, and at the end of the trial. The primary analysis was a noninferiority comparison of the mean change from baseline in the score on the spatial working memory strategy index of executive function between the patients who received evolocumab and those who received placebo; the noninferiority margin was set at 20% of the standard deviation of the score in the placebo group. Results A total of 1204 patients were followed for a median of 19 months; the mean (±SD) change from baseline over time in the raw score for the spatial working memory strategy index of executive function (primary end point) was -0.21±2.62 in the evolocumab group and -0.29±2.81 in the placebo group (Pfunction was observed over a median of 19 months. (Funded by Amgen; EBBINGHAUS ClinicalTrials.gov number, NCT02207634 .).
Gustafsson, Finn; Atar, Dan; Pitt, Bertram
, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...
May 20, 2004 ... The conflict between the design of efficacy trials that give a reasonably sound answer to a very narrow question address- ing a very limited population and the design of effectiveness trials that evaluate complex questions in a more heterogeneous and “real world” population is one example. The former pro-.
S?nchez-Villegas, Almudena; Mart?nez-Gonz?lez, Miguel Angel; Estruch, Ram?n; Salas-Salvad?, Jordi; Corella, Dolores; Covas, Maria Isabel; Ar?s, Fernando; Romaguera, Dora; G?mez-Gracia, Enrique; Lapetra, Jos?; Pint?, Xavier; Mart?nez, Jose Alfredo; Lamuela-Ravent?s, Rosa Mar?a; Ros, Emilio; Gea, Alfredo
BACKGROUND: A few observational studies have found an inverse association between adherence to a Mediterranean diet and the risk of depression. Randomized trials with an intervention based on this dietary pattern could provide the most definitive answer to the findings reported by observational studies. The aim of this study was to compare in a randomized trial the effects of two Mediterranean diets versus a low-fat diet on depression risk after at least 3 years of intervention. METHOD...
Kreiner, Frederik; Galbo, Henrik
To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR....
Kreiner, Frederik; Galbo, Henrik
To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....
Nilsson, Philip Mørkeberg; Todsen, Tobias; Subhi, Yousif; Graumann, Ole; Nolsøe, Christian Pallson; Tolsgaard, Martin Grønnebæk
Ultrasound training is associated with a long learning curve and use of substantial faculty resources. Self-directed ultrasound training may decrease the need for faculty-led teaching. Mobile apps seem promising for use in self-directed ultrasound training, but no studies have examined the cost-effectiveness of mobile app-guided training versus traditional formats such as textbook-guided training. This study evaluated the cost-effectiveness of mobile app-guided versus textbook-guided ultrasound training. First-year residents (n = 38) with no previous ultrasound experience were randomized into mobile app-guided versus textbook-guided self-directed ultrasound training groups. Participants completed a transfer test involving four patient cases and a theoretical test on diagnostic accuracy. Two ultrasound experts assessed the residents' performance using the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale. The costs of developing mobile app and textbook material were calculated and used for the analysis of cost-effectiveness. 34 participants completed the transfer test. There was no statistically significant difference in test performance or diagnostic accuracy between the mobile app-guided (mean-OSAUS 42.3 % [95 %CI38.5 - 46.0 %]) and textbook-guided groups (mean-OSAUS 45.3 % [95 %CI39.3 - 51.3 %]) (d.f. [1.33] = 0.45, p = 0.41). However, development costs differed greatly for each instructional format. Textbook-guided training was significantly more cost-effective than mobile app-guided training (Incremental Cost Effectiveness Ratio -861 967 [95 %CI-1071.7 to-3.2] USD/pct. point change in OSAUS score). Mobile app-guided ultrasound training is less cost-effective than textbook-guided self-directed training. This study underlines the need for careful evaluation of cost-effectiveness when introducing technological innovations for clinical skills training. © Georg Thieme Verlag KG Stuttgart · New York.
Full Text Available Abstract Background Randomized controlled trials (RCTs are the gold standard for trials assessing the effects of therapeutic interventions; therefore it is important to understand how they are conducted. Our objectives were to provide an overview of a representative sample of pediatric RCTs published in 2007 and assess the validity of their results. Methods We searched Cochrane Central Register of Controlled Trials using a pediatric filter and randomly selected 300 RCTs published in 2007. We extracted data on trial characteristics; outcomes; methodological quality; reporting; and registration and protocol characteristics. Trial registration and protocol availability were determined for each study based on the publication, an Internet search and an author survey. Results Most studies (83% were efficacy trials, 40% evaluated drugs, and 30% were placebo-controlled. Primary outcomes were specified in 41%; 43% reported on adverse events. At least one statistically significant outcome was reported in 77% of trials; 63% favored the treatment group. Trial registration was declared in 12% of publications and 23% were found through an Internet search. Risk of bias (ROB was high in 59% of trials, unclear in 33%, and low in 8%. Registered trials were more likely to have low ROB than non-registered trials (16% vs. 5%; p = 0.008. Effect sizes tended to be larger for trials at high vs. low ROB (0.28, 95% CI 0.21,0.35 vs. 0.16, 95% CI 0.07,0.25. Among survey respondents (50% response rate, the most common reason for trial registration was a publication requirement and for non-registration, a lack of familiarity with the process. Conclusions More than half of this random sample of pediatric RCTs published in 2007 was at high ROB and three quarters of trials were not registered. There is an urgent need to improve the design, conduct, and reporting of child health research.
Barnard, Kayla; Klimberg, V Suzanne
Numerous clinical trials reveal new innovations and therapies that continually change the treatment and prevention of breast cancer. Earlier trials have changed the standard of care from radical mastectomy to breast conservation therapy and individualized treatment based on tumor-specific biology. As research continues and long-term follow-up results become available, updated reviews on randomized clinics trials become exceedingly important in discerning the most effective and oncologically safe therapies to provide optimal outcomes. Published by Elsevier Inc.
Stewart, David J; Kurzrock, Razelle
Randomized controlled trials with a survival endpoint are the gold standard for clinical research, but have failed to achieve cures for most advanced malignancies. The high costs of randomized clinical trials slow progress (thereby causing avoidable loss of life) and increase health care costs. A malignancy may be caused by several different mutations. Therapies effective vs one mutation may be discarded due to lack of statistical significance across the entire population. Conversely, expensive large randomized trials may have sufficient statistical power to demonstrate benefit despite the therapy only working in subgroups. Non-cost-effective therapy is then applied to all patients (including subgroups it cannot help). Randomized trials comparing therapies with different mechanisms of action are misleading since they may conclude the therapies are "equivalent" despite benefitting different subpopulations, or may erroneously conclude that one therapy is superior simply because it targets a larger subpopulation. Furthermore, minor variances in patient selection may determine study outcome, a therapy may be discarded as ineffective despite substantial benefit in one subpopulation if harmful in another, randomized trials may more effectively detect therapies with minor benefit in most patients vs marked benefit in subpopulations, and randomized trials in unselected patients may erroneously conclude that "shot-gun" combinations are superior to single agents when sequential administration of personalized single agents might work better and spare patients treatment with drugs that cannot help them. We must identify predictive biomarkers early by comparing responding to progressing patients in phase I-II trials. Enriching randomized trials for biomarker-positive patients can markedly reduce required patient numbers and costs despite expensive screening for biomarker-positive patients. Available data support approval of new drugs without randomized trials if they yield
Hak, AE; Bak, AAA; Lindemans, J; Planellas, J; Bennink, HJTC; Hofman, A; Grobbee, DE; Witteman, JCM
Serum homocysteine levels may be lowered by hormone replacement therapy, but randomized controlled trial data are scarce. We performed a single center randomized placebo-controlled trial to assess the 6 months effect of hormone replacement therapy compared with placebo on fasting serum homocysteine
Jack, Darby W; Asante, Kwaku Poku; Wylie, Blair J; Chillrud, Steve N; Whyatt, Robin M; Ae-Ngibise, Kenneth A; Quinn, Ashlinn K; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth
Household air pollution exposure is a major health risk, but validated interventions remain elusive. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .
Purgato, M; Barbui, C; Stroup, S; Adams, C
At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but 'local' and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials.
Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A
To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright Â© 2016 Elsevier Ltd. All rights reserved.
Feng, Xiping; He, Tao; Cao, Michelle; He, Yanyan; Ji, Nelson
To assess the anti-plaque efficacy of an oral hygiene regimen comprised of a stannous-containing sodium fluoride dentifrice, advanced manual toothbrush, and a cetylpyridinium chloride (CPC) rinse compared to a negative control regimen. This was a 4-week randomized and controlled, parallel group, single-center, single- blind, clinical trial in generally healthy Chinese adults with existing dental plaque. Following a 1-week acclimation period and cessation of overnight oral hygiene prior to the baseline examination, overnight pre-brushing plaque levels were assessed via digital plaque imaging analysis (DPIA). Subjects were randomly assigned to either: (1) the test regimen of a stannous-containing sodium fluoride dentifrice (Crest Pro-Health Expert), an advanced manual toothbrush with CrissCross bristles (Crest Pro-Health manual toothbrush), and a 0.07% CPC rinse (Crest Pro-Health Multi-Protection); or (2) the negative control regimen group, a 0.243% sodium fluoride dentifrice (Crest Cavity Protection) and a soft flat trim manual toothbrush (Crest MeiLiLiangJie). Subjects returned at Week 2 and Week 4 following twice daily use of their assigned products, again following pre-visit cessation of overnight oral hygiene, for DPIA evaluation of overnight plaque levels. 35 fully evaluable subjects completed the trial. At Week 2, the pre-brushing overnight average DPIA plaque scores for the advanced products regimen group were 72.4% statistically significantly lower relative to the control group (Pplaque inhibition benefit provided by the regimen group was 76.8% greater than the control group (P< 0.0001). All products were well-tolerated. (Am J Dent 2016;29:120-124)
Study protocol: a cluster randomized controlled trial to assess the effectiveness of a multi-pronged behavioural intervention to improve use of personal protective equipment among migrant workers exposed to organic solvents in small and medium-sized enterprises.
Chen, Wen; Li, Tongyang; Zou, Guanyang; Li, Xudong; Shi, Leiyu; Feng, Shanshan; Shi, Jingrong; Zhou, Fangjing; Han, Siqi; Ling, Li
In China, most of migrant workers work in the small and medium-sized enterprises (SMEs) and are a vulnerable group for occupational health. Migrant workers are at increased risk of occupational health risks due to poor occupational health behaviours such as the low use of personal protective equipment (PPE). However, there is a lack of solid evidence regarding how to improve the use of PPE among migrant workers in SMEs. The current study will assess the effectiveness of a multi-pronged behavioural intervention designed to promote PPE utilization among migrant workers exposed to organic solvents in SMEs. This is a single blind, three-arm cluster randomized trial with 60 SMEs equally randomized to receive a top-down intervention (i.e. general health education and mHealth intervention provided by researchers) or a comprehensive intervention (which includes both top-down intervention and peer education) or a control condition (participants will not receive the intervention, but study measures will be obtained). Interventions will be conducted at the SMEs level for 6 months and all eligible migrant workers in these SMEs will be enrolled into the trial. The primary outcome is effective use of PPE during the last week. The secondary outcomes are occupational health knowledge and attitude and participation in occupational health check-up. Data will be collected and assessed at baseline; 3 months post baseline and the end of the intervention. This theory- and evidence based intervention will contribute to the limited evidence of behaviour change intervention in improving PPE utilization of migrant workers in SMEs, and provide timely evidence for the development of basic occupational health services in China and elsewhere with similar industrialization contexts. ChiCTR-IOR-15006929 . Registered on 16 August 2015.
Mayer, Tom G; Gatchel, Robert J; Keeley, Janice; McGeary, Don; Dersh, Jeffrey; Anagnostis, Christopher
A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies. To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR. Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome. From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly
Newton, Katherine M; Reed, Susan D; Guthrie, Katherine A; Sherman, Karen J; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S; Learman, Lee A; Freeman, Ellen W; Cohen, Lee S; Joffe, Hadine; Anderson, Garnet L; Larson, Joseph C; Hunt, Julie R; Ensrud, Kristine E; LaCroix, Andrea Z
This study aims to determine the efficacy of yoga in alleviating vasomotor symptoms (VMS) frequency and bother. This study was a three-by-two factorial, randomized controlled trial. Eligible women were randomized to yoga (n = 107), exercise (n = 106), or usual activity (n = 142), and were simultaneously randomized to a double-blind comparison of ω-3 fatty acid (n = 177) or placebo (n = 178) capsules. Yoga intervention consisted of 12 weekly 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6 weeks, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Among 249 randomized women, 237 (95%) completed 12-week assessments. The mean baseline VMS frequency was 7.4 per day (95% CI, 6.6 to 8.1) in the yoga group and 8.0 per day (95% CI, 7.3 to 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n = 237). There was no difference between intervention groups in the change in VMS frequency from baseline to 6 and 12 weeks (mean difference [yoga--usual activity] from baseline at 6 wk, -0.3 [95% CI, -1.1 to 0.5]; mean difference [yoga--usual activity] from baseline at 12 wk, -0.3 [95% CI, -1.2 to 0.6]; P = 0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga - usual activity] in the change in Insomnia Severity Index, 1.3 [95% CI, -2.5 to -0.1]; P = 0.007). Among healthy women, 12 weeks of yoga class plus home practice, compared with usual activity, do not improve VMS frequency or bother but reduce insomnia symptoms.
Mutsaerts, Meike A. Q.; van Oers, Anne M.; Groen, Henk; Burggraaff, Jan M.; Kuchenbecker, Walter K. H.; Perquin, Denise A. M.; Koks, Carolien A. M.; van Golde, Ron; Kaaijk, Eugenie M.; Schierbeek, Jaap M.; Oosterhuis, Gerrit J. E.; Broekmans, Frank J.; Bemelmans, Wanda J. E.; Lambalk, Cornelis B.; Verberg, Marieke F. G.; van der Veen, Fulco; Klijn, Nicole F.; Mercelina, Patricia E. A. M.; van Kasteren, Yvonne M.; Nap, Annemiek W.; Brinkhuis, Egbert A.; Vogel, Niels E. A.; Mulder, Robert J. A. B.; Gondrie, Ed T. C. M.; de Bruin, Jan P.; Sikkema, J. Marko; de Greef, Mathieu H. G.; ter Bogt, Nancy C. W.; Land, Jolande A.; Mol, Ben W. J.; Hoek, Annemieke
BACKGROUND Small lifestyle-intervention studies suggest that modest weight loss increases the chance of conception and may improve perinatal outcomes, but large randomized, controlled trials are lacking. METHODS We randomly assigned infertile women with a body-mass index (the weight in kilograms
Nicholas, Angela; Bailey, Julia V; Stevenson, Fiona; Murray, Elizabeth
Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants' experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement. Our goal was to determine participants' views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention. We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology: (1) individual interviews with 22 participants from the pilot RCT, (2) 133 emails received by the trial coordinator from trial participants, and (3) 217 free-text comments from the baseline and follow-up questionnaires. Interviews were audio-recorded and transcribed verbatim. An iterative, thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology. Interview participants found the trial design, including online recruitment via Facebook, online registration, email communication with the researchers, and
Guo, Jia-Wen; Sward, Katherine A; Beck, Susan L; Staggers, Nancy
Results of randomized controlled trials (RCTs) provide high-level evidence for evidence-based practice (EBP). The quality of RCTs has a substantial influence on providing reliable knowledge for EBP. Little is known about the quality of RCT reporting in cancer nursing. The aim of this study was to assess the quality of reporting in published cancer nursing RCTs from 1984 to 2010. A total of 227 RCTs in cancer nursing published in English-language journals and indexed in PubMed or Cumulative Index to Nursing and Allied Health Literature were reviewed using the Jadad scale, key methodologic index (KMI), and the Consolidated Standards of Reporting Trials (CONSORT) checklist to assess the quality of reporting methodological aspects of research and the overall quality of reporting RCTs. Adherence to reporting metrics was relatively low, based on the Jadad score (M = 1.94 out of 5, SD = 1.01), KMI scores (M = 0.84 out of 3, SD = .87), and adherence to CONSORT checklist items (M =16.92 out of 37, SD = 4.03). Only 11 of 37 items in the CONSORT checklist were reported in 80% or more of the studies reviewed. The quality of reporting showed some improvement over time. Adherence to reporting metrics for cancer nursing RCTs was suboptimal, and further efforts are needed to improve both methodology reporting and overall reporting. Journals are encouraged to adopt the CONSORT checklist to influence the quality of RCT reports.
Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick
The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…
Full Text Available Alex Thabane,1,2 Brittany B Dennis,3,4 Olga Gajic-Veljanoski,3,9,10 James Paul,2,3 Lehana Thabane2,3,5-8 1Life Sciences Program, Queen’s University, Kingston, ON, Canada; 2Department of Anesthesia, McMaster University Hamilton ON, 3Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada; 4St. George’s University of London, London England, UK; 5Population Health Research Institute, Hamilton Health Sciences, 6Department of Pediatrics, McMaster University, Hamilton, ON, Canada; 7Centre for Evaluation of Medicine, 8Biostatistics Unit, Father Sean O’Sullivan Research Centre, St Joseph’s Healthcare, Hamilton, ON, Canada; 9Department of Medicine, McMaster University, Hamilton ON, Canada; 10Hamilton Health Sciences, St. Peter’s Hospital, Hamilton, ON Canada Background: Stepped wedge design (SWD is a cluster randomized controlled trial (RCT design that sequentially rolls out intervention to all clusters at varying time points. Being a relatively new design method, reporting quality has yet to be explored, and this review will seek to fill this gap in knowledge. Objectives: The objectives of this review are: 1 to assess the quality of SWD trial reports based on the CONSORT guidelines or CONSORT extension to cluster RCTs; 2 to assess the completeness of reporting of SWD trial abstracts using the CONSORT extension for abstracts; 3 to assess the reporting of sample size details in SWD trial reports or protocols; 4 to assess the completeness of reporting of SWD trial protocols according to SPIRIT guidelines; 5 to assess the consistency between the trial registration information and final SWD trial reports; and 6 to assess the consistency of what is reported in the abstracts and main text of the SWD trial reports. We will also explore factors that are associated with the completeness of reporting. Methods: We will search MEDLINE, EMBASE, Web of Science, CINAHL, and PsycINFO for all randomized controlled trials
Bergh, Ingunn H; van Stralen, Maartje M; Grydeland, May; Bjelland, Mona; Lien, Nanna; Andersen, Lene F; Anderssen, Sigmund A; Ommundsen, Yngvar
There is a shortage of information about the factors that mediate physical activity intervention effects which involve youth. The purpose of this study was to examine whether personal, social and physical-environmental factors mediated the intervention effect on physical activity and whether gender and weight status moderated mediated effects in the Health In Adolescents Study - a school-based intervention to promote healthy weight development among young adolescents. Participating schools were randomized to Control (n = 25) and Intervention (n = 12). The intervention components to enhance physical activity targeted change through theoretically informed mediators embedded in a social-ecological framework. Accelerometer assessed physical activity (mean count per minute) and self-efficacy, enjoyment, perceived social support from parents, teachers and friends and perceived environmental opportunities were measured by questionnaires at baseline and post-intervention after 20 months among 700 11-13 year-old adolescents (Intervention = 485; Control = 215). The product-of-coefficient test was used to examine mediation. No mediating effect of any of the hypothesized mediators was identified and gender and weight status did not moderate any mediated effects with the exception of weight status that moderated the mediated effect of enjoyment. Few intervention effects were seen on the mediators, except for a positive change in social support from teachers among girls and the normal weight, and a negative effect on enjoyment and self-efficacy among the overweight. However, change in enjoyment, self-efficacy, perceived social support from friends and environmental opportunities were associated with change in mean count per minute with some variation across the investigated subgroups, and thus show evidence of being potential mediators of physical activity change in adolescents. While no mediation effects were observed, change in both personal and social-environmental factors
Р. А. Найденов
Full Text Available Aim. The aim of this randomized study was to evaluate the safety and efficacy of septal myectomy (SM and alcohol septal ablation (ASA in patients with an obstructive form of hypertrophic cardiomyopathy.Methods. The study included 76 patients eligible for ASA and Morrow myectomy. The patients were divided into two equal groups: one for ASA (n = 38, the other for SM.The primary endpoint (combined was to assess the safety, which included 30-day complications after surgery (mortality, bleeding, tamponade, stroke, development of VT / VF and the frequency of pacemaker/ICD implantation.Secondary endpoints focused on the evaluation of pressure gradient (efficiency, repeated operations, clinical and functional indicators, volume and mass of the ablation zone and dissected infarction. Control observation period was 12 months.Results. By the end of control observations, it was found out that SM is a safer technique as compared to ASA, the complication rate was 13 % and 47 % respectively (log-rank test p = 0.0021; Cox: HR 11.4 95% CI [1.52 -11.1] p = 0.005. No significant differences in early (30 days postoperative complications were found (log-rank test p = 0.24; Cox: HR 2.52, 95% CI [0.48-12.9] p = 0.27. Rhythm disturbances requiring pacemaker implantation / ICD (log-rank test p = 0.0029; Cox: HR 95% CI 4.92 [1.06-22.74] p = 0.042 were the most common complication. In both groups, there was a significant reduction of the LVOT gradient, p <0.01. However, the residual gradient in the ASA group was significantly higher than that in the SM group, p <0.01. Clinical data of both groups were comparable in the long term. A significant correlation was observed between the dissected infarction volume and the degree of reduction in the LVOT gradient of the SM group, p = 0.01. No significant dependency of the ablation zone volume on the degree of reduction in the LVOT gradient was observed, p = 0.7.Conclusion. Septal myectomy is a safe treatment for hypertrophic
Bergh Ingunn H
Full Text Available Abstract Background There is a shortage of information about the factors that mediate physical activity intervention effects which involve youth. The purpose of this study was to examine whether personal, social and physical-environmental factors mediated the intervention effect on physical activity and whether gender and weight status moderated mediated effects in the Health In Adolescents Study – a school-based intervention to promote healthy weight development among young adolescents. Methods Participating schools were randomized to Control (n = 25 and Intervention (n = 12. The intervention components to enhance physical activity targeted change through theoretically informed mediators embedded in a social-ecological framework. Accelerometer assessed physical activity (mean count per minute and self-efficacy, enjoyment, perceived social support from parents, teachers and friends and perceived environmental opportunities were measured by questionnaires at baseline and post-intervention after 20 months among 700 11–13 year-old adolescents (Intervention = 485; Control = 215. The product-of-coefficient test was used to examine mediation. Results No mediating effect of any of the hypothesized mediators was identified and gender and weight status did not moderate any mediated effects with the exception of weight status that moderated the mediated effect of enjoyment. Few intervention effects were seen on the mediators, except for a positive change in social support from teachers among girls and the normal weight, and a negative effect on enjoyment and self-efficacy among the overweight. However, change in enjoyment, self-efficacy, perceived social support from friends and environmental opportunities were associated with change in mean count per minute with some variation across the investigated subgroups, and thus show evidence of being potential mediators of physical activity change in adolescents. Conclusions While no
Full Text Available Background/Aims: This study explores the effective outcomes of a structured cognitive stimulation treatment to improve cognition and behavioral symptoms in people with dementia (PWDs, using a randomized controlled clinical trial. Methods: Thirty PWDs were divided into three groups: experimental (treated with cognitive stimulation, placebo (treated with occupational therapy, and control (continuing with the usual activities of the nursing home. Assessment, at baseline and after a period of 8 weeks, was performed using the Clinical Dementia Rating Scale, activities of daily living, Mini-Mental State Examination, Esame Neuropsicologico Breve 2, Geriatric Depression Scale and Behavioral Pathology in Alzheimer's Disease Scale. Results: Only the experimental group improved its performance in cognitive tests (p Conclusions: The results suggest that a cognitive stimulation treatment for PWDs would improve not only their cognition, but also behavioral symptoms.
Brölmann, Fleur E; Eskes, Anne M; Sumpio, Bauer E
. Randomized clinical trials (RCTs) are universally acknowledged as the study design of choice for comparing treatment effects. To give high-level evidence the appreciation it deserves in wound care, we propose a step-by-step reporting standard for comprehensive and transparent reporting of RCTs in wound care......In wound care research, available high-level evidence according to the evidence pyramid is rare, and is threatened by a poor study design and reporting. Without comprehensive and transparent reporting, readers will not be able to assess the strengths and limitations of the research performed....... Critical reporting issues (e.g., wound care terminology, blinding, predefined outcome measures, and a priori sample size calculation) and wound-specific barriers (e.g., large diversity of etiologies and comorbidities of patients with wounds) that may prevent uniform implementation of reporting standards...
Stice, Eric; Burton, Emily; Bearman, Sarah Kate; Rohde, Paul
This trial compared a brief group cognitive-behavioral (CBT) depression prevention program to a waitlist control condition and four placebo or alternative interventions. High-risk adolescents with elevated depressive symptoms (N = 225, M age = 18, 70% female) were randomized to CBT, supportive-expressive group intervention, bibliotherapy, expressive writing, journaling, or waitlist conditions and completed assessments at baseline, termination, and 1-month and 6-month follow-up. All five active interventions showed significantly greater reductions in depressive symptoms at termination than waitlist controls; effects for CBT and bibliotherapy persisted into follow-up. CBT, supportive-expressive, and bibliotherapy participants also showed significantly greater decreases in depressive symptoms than expressive writing and journaling participants at certain follow-up points. Findings suggest there may be multiple ways to reduce depressive symptoms in high-risk adolescents, although expectancies, demand characteristics, and attention may have contributed to the observed effects. PMID:17007812
Waller, L A
Harold S. Diehl and coworkers published results from a remarkable trial on the efficacy of vaccines for the common cold in 1938. The original report states that patients were assigned to treatment and control groups "at random." Diehl's study has been referred to as one of the first instances of a randomized, double-blind, placebo-controlled trial. No description of a formal randomization scheme is given in the 1938 report and an unpublished paper of Diehl's suggests the use of alternate assignment in the study.
Cousineau, Tara M.; Green, Traci C.; Corsini, Evelyn; Seibring, A; Showstack, Marianne T.; Applegarth, Linda; Davidson, Marie; Perloe, Mark
BACKGROUND The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients. METHODS A randomized-controlled trial was conducted. Using a Solomon-four group design, 190 female patients were recruited from three US fertility centers and were randomized into two experimental and two no-treatment control groups. The psychological outcomes assessed included infertility distress, infertility self-efficacy, decisional conflict, marital cohesion and coping style. Program dosage and satisfaction were also assessed at four weeks follow-up. RESULTS Women exposed to the online program significantly improved in the area of social concerns (P = 0.038) related to infertility distress, and felt more informed about a medical decision with which they were contending (P = 0.037). Trends were observed for decreased global stress (P = 0.10), sexual concerns (P = 0.059), distress related to child-free living (P = 0.063), increased infertility self-efficacy (P = 0.067) and decision making clarity (P = 0.079). A dosage response was observed in the experimental groups for women who spent >60 min online for decreased global stress (P = 0.028) and increased self efficacy (P = 0.024). CONCLUSIONS This evidence-based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective resource for fertility practices. PMID:18089552
Modaresi, Mohammad Reza; Faghihinia, Jamal; Kelishadi, Roya; Reisi, Mohsen; Mirlohi, Shahrokh; Pajhang, Farhad; Sadeghian, Majid
To assess the efficacy of nebulized magnesium sulfate as a bronchodilator in infants hospitalized with acute bronchiolitis. This three-center double masked randomized clinical trial comprised 120 children with moderate to severe bronchiolitis. They were randomly assigned into two groups: the first group was treated with nebulized magnesium sulfate (40 mg/kg) and nebulized epinephrine (0.1 ml/kg) and the second group (control) was treated with nebulized epinephrine (0.1 ml/kg). The primary outcome was the length of hospital stay. The use of oxygen, temperature, oxygen saturation (SPO2), pulse rate (PR), respiratory rate (RR) and respiratory distress assessment instrument (RDAI) score were measured in the beginning of the study and during hospitalization. The mean (SD) age of 120 infants was 5.1(± 2.6) mo and 60% were boys. The length of hospital stay was not different between the two groups (P > 0.01). Use of oxygen supplementation, SPO2 and vital signs were similar in the two groups. Improvement in RDAI score was significantly better in infants treated with nebulized magnesium sulfate than in the other group (P 0.01). Thus, in infants with acute bronchiolitis, the effect of nebulized magnesium sulfate is comparable to nebulized epinephrine. However nebulized magnesium sulfate can improve the clinical score so it may have additive effect to reduce symptoms during hospitalization.
Paris, S; Hopfenmuller, W; Meyer-Lueckel, H
Resin infiltration is an innovative approach to arrest progression of caries lesions. The aim of this randomized split-mouth placebo-controlled clinical trial was to assess whether resin infiltration of proximal lesions is more effective than non-operative measures alone with respect to the inhibition of caries progression. In 22 young adults, 29 pairs of interproximal lesions with radiological extension into the inner half of enamel or the outer third of dentin were randomly allocated to two treatment groups. In the test group, lesions were infiltrated (Icon, pre-product; DMG). A placebo treatment was performed in the control group. All participants received instructions for diet, flossing, and fluoridation. The primary outcome after 18 months was radiographic lesion progression (assessed by digital subtraction radiography). No unwanted effects could be observed. In the effect group, 2/27 lesions (7%) and in the control group 10/27 lesions (37%) showed progression (p = 0.021; McNemar). Infiltration of interproximal caries lesions is efficacious in reducing lesion progression.
Freidlin, Boris; Little, Richard F; Korn, Edward L
A potential therapeutic strategy for patients who respond (or have stable disease) on a fixed-duration induction therapy is to receive maintenance therapy, typically given for a prolonged period of time. To enable patients and clinicians to make informed treatment decisions, the designs of phase III randomized clinical trials (RCTs) assessing maintenance strategies need to be such that their results will provide clear assessment of the relevant risks and benefits of these strategies. We review the key aspects of maintenance RCT designs. Important design considerations include choice of first-line and second-line therapies, minimizing between-arm differences in follow-up schedules, and choice of the primary endpoint. In order to change clinical practice, RCTs should be designed to accurately isolate and quantify the clinical benefit of maintenance as compared with the standard approach of fixed-duration induction followed by the second-line treatment at progression. To accomplish this, RCTs need to utilize an overall survival (or quality of life) endpoint or, in settings where this is not feasible, endpoints that incorporate the effects of the subsequent line of therapy (eg, time from randomization to second progression or death). Toxicity and symptom information over both the study treatment (maintenance) and the second-line treatment should also be collected and reported. Published by Oxford University Press 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.
Ee, Carolyn; Xue, Charlie; Chondros, Patty; Myers, Stephen P; French, Simon D; Teede, Helena; Pirotta, Marie
Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting. To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs. Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954). Community in Australia. Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency. 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture. The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models. 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, -1.87 to 2.52]; P = 0.77). No serious adverse events were reported. Participants were predominantly Caucasian and did not have breast cancer or surgical menopause. Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs. National Health and Medical Research Council.
Full Text Available Abstract Background Patients with stroke should have access to a continuum of care from organized stroke units in the acute phase, to appropriate rehabilitation and secondary prevention measures. Moreover to improve the outcomes for acute stroke patients from an organizational perspective, the use of multidisciplinary teams and the delivery of continuous stroke education both to the professionals and to the public, and the implementation of evidence-based stroke care are recommended. Clinical pathways are complex interventions that can be used for this purpose. However in stroke care the use of clinical pathways remains questionable because little prospective controlled data has demonstrated their effectiveness. The purpose of this study is to determine whether clinical pathways could improve the quality of the care provided to the patients affected by stroke in hospital and through the continuum of the care. Methods Two-arm, cluster-randomized trial with hospitals and rehabilitation long-term care facilities as randomization units. 14 units will be randomized either to arm 1 (clinical pathway or to arm 2 (no intervention, usual care. The sample will include 238 in each group, this gives a power of 80%, at 5% significance level. The primary outcome measure is 30-days mortality. The impact of the clinical pathways along the continuum of care will also be analyzed by comparing the length of hospital stay, the hospital re-admissions rates, the institutionalization rates after hospital discharge, the patients' dependency levels, and complication rates. The quality of the care provided to the patients will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and rehabilitation, and by the use of key quality indicators at discharge. The implementation of organized care will be also evaluated. Conclusion The management of patients affected by stroke involves the expertise of several professionals, which can
Assessment of the effect of combined multimedia and verbal information vs verbal information alone on anxiety levels before bond-up in adolescent orthodontic patients: a single-center randomized controlled trial.
Srai, Jemnique Pal Kaur; Petrie, Aviva; Ryan, Fiona S; Cunningham, Susan J
Despite the high prevalence of dental anxiety in children, there is little research examining anxiety before orthodontic procedures. This parallel-group randomized controlled trial assessed whether provision of additional multimedia information regarding the bond-up procedure affected anxiety in adolescent orthodontic patients. The effects of sex, ethnicity, and age were also investigated. Participants were recruited from the orthodontic department of the Eastman Dental Hospital, University College London Hospitals Foundation Trust, in the United Kingdom; all were 10 to 16 years of age, with no history of orthodontic treatment, and patient assent and parental consent were obtained. The participants were randomized into control (n = 45) and intervention (n = 45) groups using a random number table. Both groups were given verbal information regarding the bond-up procedure, and the intervention group was additionally given a DVD showing a bond-up. Anxiety was assessed in the department immediately before the bond-up using the State-Trait Anxiety Inventory for Children, with state anxiety as the primary outcome measure. The researchers were unaware of group allocations while enrolling patients, scoring questionnaires, and analyzing data. A statistically significant difference was found between groups, with a difference in scores of 2 (95% confidence interval for the difference = 0.15 to 3.85). The median state anxiety was 32 in the control group (n = 42) and 30 in the intervention group (n = 43; P = 0.012). Sex, ethnicity, and age did not significantly affect anxiety. No harmful effects were noted. Additional information reduces anxiety levels, but other methods could be more cost-effective than the DVD. Sex, ethnicity, and age did not statistically affect the anxiety levels. Copyright © 2013 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.
Knatterud, Genell L
In preparing to undertake a clinical trial, it may be helpful to keep in mind Fredrickson's description of clinical trials (31): "Field trials are indispensable. They will continue to be an ordeal. They lack glamour, they strain our resources and patience, and they protract the moment of truth to excruciating limits. Still, they are among the most challenging tests of our skills. I have no doubt that when the problem is well chosen, the study is appropriately designed, and that when all the populations concerned are made aware of the route and the goal, the reward can be commensurate with the effort. If, in major medical dilemmas, the alternative is to pay the costs of perpetual uncertainty, have we really any choice?"
Corneli, Howard M; Zorc, Joseph J; Mahajan, Prashant; Majahan, Prashant; Shaw, Kathy N; Holubkov, Richard; Reeves, Scott D; Ruddy, Richard M; Malik, Baqir; Nelson, Kyle A; Bregstein, Joan S; Brown, Kathleen M; Denenberg, Matthew N; Lillis, Kathleen A; Cimpello, Lynn Babcock; Tsung, James W; Borgialli, Dominic A; Baskin, Marc N; Teshome, Getachew; Goldstein, Mitchell A; Monroe, David; Dean, J Michael; Kuppermann, Nathan
Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited. We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score > or =6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events. Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, -1.3%; 95% confidence interval [CI], -9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was -5.3 for dexamethasone, as compared with -4.8 for placebo (absolute difference, -0.5; 95% CI, -1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes. In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
Glanville, Julie M.; Lefebvre, Carol; Miles, Jeremy N. V.; Camosso-Stefinovic, Janette
Objective: The researchers sought to assess whether the widely used 1994 Cochrane Highly Sensitive Search Strategy (HSSS) for randomized controlled trials (RCTs) in MEDLINE could be improved in terms of sensitivity, precision, or parsimony. Methods: A gold standard of 1,347 RCT records and a comparison group of 2,400 non-trials were randomly selected from MEDLINE. Terms occurring in at least 1% of RCT records were identified. Fifty percent of the RCT and comparison group records were randomly selected, and the ability of the terms to discriminate RCTs from non-trial records was determined using logistic regression. The best performing combinations of terms were tested on the remaining records and in MEDLINE. Results: The best discriminating term was “Clinical Trial” (Publication Type). In years where the Cochrane assessment of MEDLINE records had taken place, the strategies identified few additional unindexed records of trials. In years where Cochrane assessment has yet to take place, “Randomized Controlled Trial” (Publication Type) proved highly sensitive and precise. Adding six more search terms identified further, unindexed trials at reasonable levels of precision and with sensitivity almost equal to the Cochrane HSSS. Conclusions: Most reports of RCTs in MEDLINE can now be identified easily using “Randomized Controlled Trial” (Publication Type). More sensitive searches can be achieved by a brief strategy, the Centre for Reviews and Dissemination/Cochrane Highly Sensitive Search Strategy (2005 revision). PMID:16636704
Radiotherapy Breast Boost With Reduced Whole-Breast Dose Is Associated With Improved Cosmesis: The Results of a Comprehensive Assessment From the St. George and Wollongong Randomized Breast Boost Trial
Hau, Eric, E-mail: email@example.com [Cancer Care Centre, St. George Hospital, Kogarah, Sydney (Australia); Browne, Lois H.; Khanna, Sam; Cail, Stacy; Cert, Grad; Chin, Yaw; Clark, Catherine; Inder, Stephanie; Szwajcer, Alison; Graham, Peter H. [Cancer Care Centre, St. George Hospital, Kogarah, Sydney (Australia)
Purpose: To evaluate comprehensively the effect of a radiotherapy boost on breast cosmetic outcomes after 5 years in patients treated with breast-conserving surgery. Methods: The St. George and Wollongong trial (NCT00138814) randomized 688 patients with histologically proven Tis-2, N 0-1, M0 carcinoma to the control arm of 50 Gy in 25 fractions (342 patients) and the boost arm of 45 Gy in 25 fractions to the whole breast followed by a 16 Gy in 8 fraction electron boost (346 patients). Five-year cosmetic outcomes were assessed by a panel subjectively in 385 patients and objectively using pBRA (relative breast retraction assessment). A subset of patients also had absolute BRA measurements. Clinician assessment and patient self-assessment of overall cosmetic and specific items as well as computer BCCT.core analysis were also performed. Results: The boost arm had improved cosmetic overall outcomes as scored by the panel and BCCT.core software with 79% (p = 0.016) and 81% (p = 0.004) excellent/good cosmesis respectively compared with 68% in no-boost arm. The boost arm also had lower pBRA and BRA values with a mean difference of 0.60 and 1.82 mm, respectively, but was not statistically significant. There was a very high proportion of overall excellent/good cosmetic outcome in 95% and 93% in the boost and no-boost arms using patient self-assessment. However, no difference in overall and specific items scored by clinician assessment and patient self-assessment was found. Conclusion: The results show the negative cosmetic effect of a 16-Gy boost is offset by a lower whole-breast dose of 45 Gy.
Morris, Jill K; Vidoni, Eric D; Johnson, David K; Van Sciver, Angela; Mahnken, Jonathan D; Honea, Robyn A; Wilkins, Heather M; Brooks, William M; Billinger, Sandra A; Swerdlow, Russell H; Burns, Jeffrey M
There is increasing interest in the role of physical exercise as a therapeutic strategy for individuals with Alzheimer's disease (AD). We assessed the effect of 26 weeks (6 months) of a supervised aerobic exercise program on memory, executive function, functional ability and depression in early AD. This study was a 26-week randomized controlled trial comparing the effects of 150 minutes per week of aerobic exercise vs. non-aerobic stretching and toning control intervention in individuals with early AD. A total of 76 well-characterized older adults with probable AD (mean age 72.9 [7.7]) were enrolled and 68 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. Neuropsychological tests and surveys were conducted at baseline,13, and 26 weeks to assess memory and executive function composite scores, functional ability (Disability Assessment for Dementia), and depressive symptoms (Cornell Scale for Depression in Dementia). Cardiorespiratory fitness testing and brain MRI was performed at baseline and 26 weeks. Aerobic exercise was associated with a modest gain in functional ability (Disability Assessment for Dementia) compared to individuals in the ST group (X2 = 8.2, p = 0.02). There was no clear effect of intervention on other primary outcome measures of Memory, Executive Function, or depressive symptoms. However, secondary analyses revealed that change in cardiorespiratory fitness was positively correlated with change in memory performance and bilateral hippocampal volume. Aerobic exercise in early AD is associated with benefits in functional ability. Exercise-related gains in cardiorespiratory fitness were associated with improved memory performance and reduced hippocampal atrophy, suggesting cardiorespiratory fitness gains may be important in driving brain benefits. ClinicalTrials.gov NCT01128361.
Ho, Tony W; Connor, Kathryn M; Zhang, Ying
a recommendation from the Safety Monitoring Board due to hepatotoxicity concerns. At termination, the planned 660 patients had been randomized, 656 had been treated with ≥ 1 dose of study medication, and 14 had completed the trial. The mean treatment duration was 48-50 days. Thirteen patients, all......OBJECTIVE: To evaluate whether the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant might be effective for migraine prevention. METHODS: In this randomized, double-blind, placebo-controlled, multicenter trial (ClinicalTrials.gov NCT00797667), patients experiencing 3......-14 migraine days during a 4-week baseline were randomized to telcagepant 140 mg, telcagepant 280 mg, or placebo twice daily for 12 weeks. Efficacy was assessed by mean monthly headache days and migraine/probable migraine days (headache plus ≥ 1 associated symptom). RESULTS: The trial was terminated following...
Is self-assessment of medical abortion using a low-sensitivity pregnancy test combined with a checklist and phone text messages feasible in South African primary healthcare settings? A randomized trial.
Full Text Available To evaluate feasibility of self-assessment of medical abortion outcome using a low-sensitivity urine pregnancy test, checklist and text messages. The study assessed whether accurate self-assessment required a demonstration of the low-sensitivity urine pregnancy test or if verbal instructions suffice.This non-inferiority trial enrolled 525 adult women from six public sector abortion clinics. Eligible women were undergoing medical abortion at gestations within 63 days. Consenting women completed a baseline interview, received standard care with mifepristone and home-administration of misoprostol. All were given a low-sensitivity urine pregnancy test and checklist for use 14 days later, sent text reminders, and asked to attend in-clinic follow-up after two weeks. Women were randomly assigned 1:1 to an instruction-only group (n = 262; issued with pre-scripted instructions on the low-sensitivity pregnancy test, or a demonstration group (n = 263; performed practice tests guided by lay health workers. The primary outcome was accurate self-assessment of incomplete abortion, defined as needing additional misoprostol or vacuum aspiration. Analysis was by intention to treat and a non-inferiority margin was set to six percentage points. Women's acceptability of their abortion procedure and preferences for follow-up were also assessed.Follow-up was 81% for abortion outcome, confirmed in-clinic at two weeks or self-reported within six months. Non-inferiority of instruction-only to a demonstration was inconclusive for accurate self-assessment (risk difference for instruction-only -demonstration: -2.5%; 95%CI: -9% to 4%. Comparing instruction-only to demonstration groups, 99% and 100% found the pregnancy test easy to do; and 91% and 93% respectively chose the pregnancy test, checklist and text messages for abortion outcome assessment in the future.Routine self-assessment using a low-sensitivity pregnancy test, checklist and text messages is feasible and
Is self-assessment of medical abortion using a low-sensitivity pregnancy test combined with a checklist and phone text messages feasible in South African primary healthcare settings? A randomized trial.
Constant, Deborah; Harries, Jane; Daskilewicz, Kristen; Myer, Landon; Gemzell-Danielsson, Kristina
To evaluate feasibility of self-assessment of medical abortion outcome using a low-sensitivity urine pregnancy test, checklist and text messages. The study assessed whether accurate self-assessment required a demonstration of the low-sensitivity urine pregnancy test or if verbal instructions suffice. This non-inferiority trial enrolled 525 adult women from six public sector abortion clinics. Eligible women were undergoing medical abortion at gestations within 63 days. Consenting women completed a baseline interview, received standard care with mifepristone and home-administration of misoprostol. All were given a low-sensitivity urine pregnancy test and checklist for use 14 days later, sent text reminders, and asked to attend in-clinic follow-up after two weeks. Women were randomly assigned 1:1 to an instruction-only group (n = 262; issued with pre-scripted instructions on the low-sensitivity pregnancy test), or a demonstration group (n = 263; performed practice tests guided by lay health workers). The primary outcome was accurate self-assessment of incomplete abortion, defined as needing additional misoprostol or vacuum aspiration. Analysis was by intention to treat and a non-inferiority margin was set to six percentage points. Women's acceptability of their abortion procedure and preferences for follow-up were also assessed. Follow-up was 81% for abortion outcome, confirmed in-clinic at two weeks or self-reported within six months. Non-inferiority of instruction-only to a demonstration was inconclusive for accurate self-assessment (risk difference for instruction-only -demonstration: -2.5%; 95%CI: -9% to 4%). Comparing instruction-only to demonstration groups, 99% and 100% found the pregnancy test easy to do; and 91% and 93% respectively chose the pregnancy test, checklist and text messages for abortion outcome assessment in the future. Routine self-assessment using a low-sensitivity pregnancy test, checklist and text messages is feasible and preferred by women
Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: firstname.lastname@example.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)
Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.
Full Text Available Abstract Background Hydroxyurea (HU has been demonstrated to be efficacious in reducing complications in individuals with sickle cell anemia (SCA but poor adherence is a barrier. Directly Observed Therapy (DOT has been shown to improve adherence in various chronic diseases but there is limited data in adults with SCA. Methods and design To examine the effect of mobile-directly observed therapy (mDOT on adherence to HU (mDOT-HuA in adults with SCA at Muhimbili National Hospital in Tanzania. The mDOT-HuA study is a single centre, prospective, randomized, open label clinical trial. One-hundred individuals with SCA with haemoglobin SS genotype, aged ≥18 years, living in Dar es Salaam, able and willing to record and submit videos electronically will be included. Participants will be divided into two treatment arms; 50 in the standard monitoring (SM arm will receive mobile phones and fixed dose HU therapy with standard monitoring; 50 in the mDOT arm will receive mobile phones, fixed dose HU therapy with standard monitoring and a mobile directly observed web based medication adherence monitoring system. The primary outcome is the proportion of participants achieving ≥80 % HU adherence compared between the two arms as assessed through medication possession ratio at the end of 3 months of treatment. REDCap, an open source software application will be used to collect data using clinical research forms. The proportions of adherence in the two arms will be compared by Fisher’s exact test. Analysis of outcomes will have performed by both the intention-to treat and per-protocol methods. Discussion Should this study become sucessful, it will have the potential for the development of novel strategies for improving HU adherence in SCA. Trial registration ClinicalTrials.gov Identifier: NCT02844673 , registered on 25tht July 2016 (retrospectively registered.
Garbutt Jane M
Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications
Hwang, Kevin O; Hamadah, Abdurrahman M; Johnson, Craig W; Thomas, Eric J; Goodrick, G Ken; Bernstam, Elmer V
Obstructive sleep apnea is underdiagnosed. We conducted a pilot randomized controlled trial of an online intervention to promote obstructive sleep apnea screening among members of an Internet weight-loss community. Members of an Internet weight-loss community who have never been diagnosed with obstructive sleep apnea or discussed the condition with their healthcare provider were randomized to intervention (online risk assessment+feedback) or control. The primary outcome was discussing obstructive sleep apnea with a healthcare provider at 12 weeks. Of 4700 members who were sent e-mail study announcements, 168 (97% were female, age 39.5 years [standard deviation 11.7], body mass index 30.3 [standard deviation 7.8]) were randomized to intervention (n=84) or control (n=84). Of 82 intervention subjects who completed the risk assessment, 50 (61%) were low risk and 32 (39%) were high risk for obstructive sleep apnea. Intervention subjects were more likely than control subjects to discuss obstructive sleep apnea with their healthcare provider within 12 weeks (11% [9/84] vs 2% [2/84]; P=.02; relative risk=4.50; 95% confidence interval, 1.002-20.21). The number needed to treat was 12. High-risk intervention subjects were more likely than control subjects to discuss obstructive sleep apnea with their healthcare provider (19% [6/32] vs 2% [2/84]; P=.004; relative risk=7.88; 95% confidence interval, 1.68-37.02). One high-risk intervention subject started treatment for obstructive sleep apnea. An online screening intervention is feasible and likely effective in encouraging members of an Internet weight-loss community to discuss obstructive sleep apnea with their healthcare provider.
Chhangur Rabia R
Full Text Available Abstract Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes. However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-environment interactions to obtain more insight into a moderating effects of polymorphisms on the link between parenting and child behavior, and b behavioral mechanisms that underlie these gene-(gene-environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training. In a screening, families with children aged 4–8 who show mild to (subclinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest, after 6 months (i.e., posttest, and after 10 months (i.e., follow-up. Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and
Meredith, Lisa S; Eisenman, David P; Green, Bonnie L; Kaltman, Stacey; Wong, Eunice C; Han, Bing; Cassells, Andrea; Tobin, Jonathan N
Posttraumatic stress disorder (PTSD) is a common problem in primary care. Although effective treatments are available, little is known about whether such treatments are effective within the context of Federally Qualified Health Centers (FQHCs) that serve as national "safety nets" for providing primary care for low income and underinsured patients. The Violence and Stress Assessment (ViStA) study is the first randomized controlled trial (RCT) to test the impact of a care management intervention for treating PTSD in FQHCs. To develop a PTSD management intervention appropriate for lower resource FQHCs and the predominantly Latino patients they serve, formative work was conducted through a collaborative effort between researchers and an FQHC practice-based research network. This article describes how FQHC stakeholders were convened to review, assess, and prioritize evidence-based strategies for addressing patient, clinician, and system-level barriers to care. This multi-component care management intervention incorporates diagnosis with feedback, patient education and activation; navigation and linkage to community resources; clinician education and medication guidance; and structured cross-disciplinary communication and continuity of care, all facilitated by care managers with FQHC experience. We also describe the evaluation design of this five-year RCT and the characteristics of the 404 English or Spanish speaking patients enrolled in the study and randomized to either the intervention or to usual care. Patients are assessed at baseline, six months, and 12 months to examine intervention effectiveness on PTSD, other mental health symptoms, health-related quality-of-life, health care service use; and perceived barriers to care and satisfaction with care. Copyright © 2014 Elsevier Inc. All rights reserved.
Tosun, Ozge Celiker; Solmaz, Ulas; Ekin, Atalay; Tosun, Gokhan; Gezer, Cenk; Ergenoglu, Ahmet Mete; Yeniel, Ahmet Ozgur; Mat, Emre; Malkoc, Mehtap; Askar, Niyazi
[Purpose] The aim of this study was to evaluate whether the effect of pelvic floor exercises on pelvic floor muscle strength could be detected via ultrasonography in patients with urinary incontinence. [Subjects and Methods] Of 282 incontinent patients, 116 participated in the study and were randomly divided into a pelvic floor muscle training (n=65) group or control group (n=51). The pelvic floor muscle training group was given pelvic floor exercise training for 12 weeks. Both groups were ev...
Goertz, Christine M; Long, Cynthia R; Vining, Robert D; Pohlman, Katherine A; Kane, Bridget; Corber, Lance; Walter, Joan; Coulter, Ian
Low back pain is highly prevalent and one of the most common causes of disability in U.S. armed forces personnel. Currently, no single therapeutic method has been established as a gold standard treatment for this increasingly prevalent condition. One commonly used treatment, which has demonstrated consistent positive outcomes in terms of pain and function within a civilian population is spinal manipulative therapy provided by doctors of chiropractic. Chiropractic care, delivered within a multidisciplinary framework in military healthcare settings, has the potential to help improve clinical outcomes for military personnel with low back pain. However, its effectiveness in a military setting has not been well established. The primary objective of this study is to evaluate changes in pain and disability in active duty service members with low back pain who are allocated to receive usual medical care plus chiropractic care versus treatment with usual medical care alone. This pragmatic comparative effectiveness trial will enroll 750 active duty service members with low back pain at three military treatment facilities within the United States (250 from each site) who will be allocated to receive usual medical care plus chiropractic care or usual medical care alone for 6 weeks. Primary outcomes will include the numerical rating scale for pain intensity and the Roland-Morris Disability Questionnaire at week 6. Patient reported outcomes of pain, disability, bothersomeness, and back pain function will be collected at 2, 4, 6, and 12 weeks from allocation. Because low back pain is one of the leading causes of disability among U.S. military personnel, it is important to find pragmatic and conservative treatments that will treat low back pain and preserve low back function so that military readiness is maintained. Thus, it is important to evaluate the effects of the addition of chiropractic care to usual medical care on low back pain and disability. The trial discussed in this
Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco
Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (Ppsychomotricity a safe and efficacy therapy for pediatric selective mutism.
Goodman, Phyllis J.; Till, Cathee; Schenk, Jeannette M.; Lucia, M. Scott; Thompson, Ian M.
Purpose To identify factors related to who undergoes a prostate biopsy in a screened population and to estimate the impact of biopsy verification on risk factor–prostate cancer associations. Patients and Methods Men who were screened regularly from the placebo arms of two large prostate cancer prevention trials (Prostate Cancer Prevention Trial [PCPT] and Selenium and Vitamin E Cancer Prevention Trial [SELECT]) were examined to define incident prostate cancer cohorts. Because PCPT had an end-of-study biopsy, prostate cancer cases were categorized by a preceding prostate-specific antigen/digital rectal examination prompt (yes/no) and noncases by biopsy-proven negative status (yes v no). We estimated the association of risk factors (age, ethnicity, family history, body mass index, medication use) with prostate cancer and quantified differences in risk associations across cohorts. Results Men 60 to 69 years of age, those with benign prostatic hyperplasia, and those with a family history of prostate cancer were more likely, and those with a higher body mass index (≥ 25), diabetes, or a smoking history were less likely, to undergo biopsy, adjusting for age and longitudinal prostate-specific antigen and digital rectal examination. Medication use, education, and marital status also influenced who underwent biopsy. Some risk factor estimates for prostate cancer varied substantially across cohorts. Black (v other ethnicities) had odds ratios (ORs) that varied from 1.20 for SELECT (community screening standards, epidemiologic-like cohort) to 1.83 for PCPT (end-of-study biopsy supplemented with imputed end points). Statin use in SELECT provided an OR of 0.65 and statin use in in PCPT provided an OR of 0.99, a relative difference of 34%. Conclusion Among screened men enrolled in prostate cancer prevention trials, differences in risk factor estimates for prostate cancer likely underestimate the magnitude of bias found in other cohorts with varying screening and biopsy
Rutterford, Clare; Copas, Andrew; Eldridge, Sandra
The use of cluster randomized trials (CRTs) is increasing, along with the variety in their design and analysis. The simplest approach for their sample size calculation is to calculate the sample size assuming individual randomization and inflate this by a design effect to account for randomization by cluster. The assumptions of a simple design effect may not always be met; alternative or more complicated approaches are required. We summarise a wide range of sample size methods available for cluster randomized trials. For those familiar with sample size calculations for individually randomized trials but with less experience in the clustered case, this manuscript provides formulae for a wide range of scenarios with associated explanation and recommendations. For those with more experience, comprehensive summaries are provided that allow quick identification of methods for a given design, outcome and analysis method. We present first those methods applicable to the simplest two-arm, parallel group, completely randomized design followed by methods that incorporate deviations from this design such as: variability in cluster sizes; attrition; non-compliance; or the inclusion of baseline covariates or repeated measures. The paper concludes with methods for alternative designs. There is a large amount of methodology available for sample size calculations in CRTs. This paper gives the most comprehensive description of published methodology for sample size calculation and provides an important resource for those designing these trials. © The Author 2015. Published by Oxford University Press on behalf of the International Epidemiological Association.
Tellez, M; Potter, C M; Kinner, D G; Jensen, D; Waldron, E; Heimberg, R G; Myers Virtue, S; Zhao, H; Ismail, A I
Anxiety regarding dental and physical health is a common and potentially distressing problem, for both patients and health care providers. Anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. The study aimed to develop and evaluate a computerized cognitive-behavioral therapy dental anxiety intervention that could be easily implemented in dental health care settings. A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental procedures, and cognitive restructuring was developed. A randomized controlled trial was conducted (N = 151) to test its efficacy. Consenting adult dental patients who met inclusion criteria (e.g., high dental anxiety) were randomized to 1 of 2 groups: immediate treatment (n = 74) or a wait-list control (n = 77). Analyses of covariance based on intention-to-treat analyses were used to compare the 2 groups on dental anxiety, fear, avoidance, and overall severity of dental phobia. Baseline scores on these outcomes were entered into the analyses as covariates. Groups were equivalent at baseline but differed at 1-mo follow-up. Both groups showed improvement in outcomes, but analyses of covariance demonstrated significant differences in dental anxiety, fear, avoidance, and overall severity of dental phobia in favor of immediate treatment at the follow-up assessment. Of the patients who met diagnostic criteria for phobia at baseline, fewer patients in the immediate treatment group continued to meet criteria for dental phobia at follow-up as compared with the wait-list group. A new computer-based tool seems to be efficacious in reducing dental anxiety and fear/avoidance of dental procedures. Examination of its effectiveness when administered in dental offices under less controlled conditions is warranted (ClinicalTrials.gov NCT02081365). © International & American Associations for Dental Research.
Stalpers, Lukas J. A.; da Costa, Hanna C.; Merbis, Merijn A. E.; Fortuin, Andries A.; Muller, Martin J.; van Dam, Frits S. A. M.
Purpose: To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). Methods and Materials: After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT
Su, Chun-Xiang; Wang, Li-Qiong; Grant, Suzanne J; Liu, Jian-Ping
To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.
Eslami, Saeid; Askari, Marjan; Medlock, Stephanie; Arts, Derk L.; Wyatt, Jeremy C.; van Weert, Henk C. P. M.; de Rooij, Sophia E.; Abu-Hanna, Ameen
Previous efforts such as Assessing Care of Vulnerable Elders (ACOVE) provide quality indicators for assessing the care of elderly patients, but thus far little has been done to leverage this knowledge to improve care for these patients. We describe a clinical decision support system to improve
Timmers, J.M.H.; Damen, J.A.A.G.; Pijnappel, R.M.; Verbeek, A.L.M.; Heeten, GJ. den; Adang, E.M.M.; Broeders, M.J.M.
OBJECTIVE: Increased recall rates in the Dutch breast cancer screening program call for a new assessment strategy aiming to reduce unnecessary costs and anxiety. Diagnostic work-up (usual care) includes multidisciplinary hospital assessment and is similar for all recalled women, regardless of the
Hoxhaj, E; Sadohara, C; Borel, P; D'Amelio, R; Sobanski, E; Müller, H; Feige, B; Matthies, S; Philipsen, Alexandra
Mindfulness training is a promising treatment approach in adult ADHD. However, there has not yet been a randomized controlled trial comparing mindfulness to an active control condition. In this study, we assessed the efficacy of a mindfulness training program (MAP) compared to structured psychoeducation (PE). After randomization 81 medication-free adult ADHD patients participated either in an 8-week MAP or PE group program. At baseline (T1), after 8 weeks (T2) and after 8 months (T3), severity of ADHD and associated symptoms (depression, general psychopathology, quality of life) were measured with the Conner's ADHD Rating Scales (CAARS), the Beck Depression Inventory (BDI), the Brief Symptom Inventory (BSI) and the SF-36 by self and blind observer ratings. Both groups showed significant pre-post improvements in observer-rated Inattention scale (p load in adult ADHD. Furthermore in exploratory post hoc tests the study provides evidence for a potential gender-specific treatment response in adult ADHD.
Morino, T; Ookawa, K; Haruta, N; Hagiwara, Y; Seki, M
To better understand the role of the professional oral health care for elderly in improving geriatric oral health, the effects of short-term professional oral health care (once per week for 1 month) on oral microbiological parameters were assessed. Parallel, open-labelled, randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka, Japan. Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention (17/34) and control (17/34) groups. The outcomes were changes in oral microbiological parameters (number of bacteria in unstimulated saliva; whole bacteria, Streptococcus, Fusobacterium and Prevotella: opportunistic pathogens detection: and index of oral hygiene evaluation [Dental Plaque Index, DPI]) within the intervention period. Each parameter was evaluated at before and after intervention period. Four elderly were lost from mortality (1), bone fracture (1), refused to participate (1) and multi-antibiotics usage (1). Finally, 30 elderly were analysed (14/intervention and 16/control). At baseline, no difference was found between the control and intervention groups. After the intervention period, the percentage of Streptococcus species increased significantly in the intervention group (Intervention, 86% [12/14]; Control, 50% [8/16]: Fisher's, right-tailed, P oral health care can improve oral conditions in the elderly. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Hay, I C; Jamieson, M; Ormerod, A D
To investigate the efficacy of aromatherapy in the treatment of patients with alopecia areata. A randomized, double-blind, controlled trial of 7 months' duration, with follow-up at 3 and 7 months. Dermatology outpatient department. Eighty-six patients diagnosed as having alopecia areata. Eighty-six patients were randomized into 2 groups. The active group massaged essential oils (thyme, rosemary, lavender, and cedarwood) in a mixture of carrier oils (jojoba and grapeseed) into their scalp daily. The control group used only carrier oils for their massage, also daily. Treatment success was evaluated on sequential photographs by 2 dermatologists (I.C.H. and A.D.O.) independently. Similarly, the degree of improvement was measured by 2 methods: a 6-point scale and computerized analysis of traced areas of alopecia. Nineteen (44%) of 43 patients in the active group showed improvement compared with 6 (15%) of 41 patients in the control group (P = .008). An alopecia scale was applied by blinded observers on sequential photographs and was shown to be reproducible with good interobserver agreement (kappa = 0.84). The degree of improvement on photographic assessment was significant (P = .05). Demographic analysis showed that the 2 groups were well matched for prognostic factors. The results show aromatherapy to be a safe and effective treatment for alopecia areata. Treatment with these essential oils was significantly more effective than treatment with the carrier oil alone (P = .008 for the primary outcome measure). We also successfully applied an evidence-based method to an alternative therapy.
Szmuilowicz, Eytan; Neely, Kathy J; Sharma, Rashmi K; Cohen, Elaine R; McGaghie, William C; Wayne, Diane B
Inpatient Code Status Discussions (CSDs) are commonly facilitated by resident physicians, despite inadequate training. We studied the efficacy of a CSD communication skills training intervention for internal medicine residents. This was a prospective, randomized controlled trial of a multimodality communication skills educational intervention for postgraduate year (PGY) 1 residents. Intervention group residents completed a 2 hour teaching session with deliberate practice of communication skills, online modules, self-reflection, and a booster training session in addition to assigned clinical rotations. Control group residents completed clinical rotations alone. CSD skills of residents in both groups were assessed 2 months after the intervention using an 18 item behavioral checklist during a standardized patient encounter. Average scores for intervention and control group residents were calculated and between-group differences on the CSD skills assessment were evaluated using two-tailed independent sample t tests. Intervention group residents displayed higher overall scores on the simulated CSD (75.1% versus 53.2%, pgroup residents. The intervention group also displayed a greater number of key CSD communication behaviors and facilitated significantly longer conversations. The training, evaluation, and feedback sessions were rated highly. A focused, multimodality curriculum can improve resident performance of simulated CSDs. Skill improvement lasted for at least 2 months after the intervention. Further studies are needed to assess skill retention and to set minimum performance standards.
Telles, Shirley; Bhardwaj, Abhishek K.; Gupta, Ram K.; Sharma, Sachin K.; Monro, Robin; Balkrishna, Acharya
Background The present study aimed at determining whether 12 weeks of yoga practice in patients with chronic LBP and MRI-based degenerative changes would result in differences in: (i) self-reported pain, anxiety, and spinal flexibility; and (ii) the structure of the discs or vertebrae. Material/Methods Sixty-two persons with MRI-proven degenerative intervertebral discs (group mean ?S.D., 36.2?6.4 years; 30 females) were randomly assigned to yoga and control groups. However, testing was conduc...
Schwebel, David C.; McClure, Leslie A.; Severson, Joan
Objective Child pedestrian injury is a global public health challenge. This randomized controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and websites, plus no-training control, to improve children’s street-crossing ability. Methods Pedestrian safety was evaluated among 231 seven- and eight-year-olds using both streetside (field) and laboratory-based (virtual environment) trials prior to intervention group assignment, immediately post-training, and six months post-training. All training groups received six 30-minute sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior post-intervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly post-training than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in post-intervention VR trials. Children showed minimal change in attention to traffic post-training. Children trained with videos/websites showed minimal learning. Conclusion Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds’ street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly
Brønd, Marie; Martins, Cesario L; Byberg, Stine
Background: Two doses of measles vaccine (MV) might reduce the nonmeasles mortality rate more than 1 dose of MV does. The effect of 2 versus 1 dose on morbidity has not been examined. Within a randomized trial of the effect of 2 doses versus 1 dose of MV on mortality in Guinea-Bissau, we investig......Background: Two doses of measles vaccine (MV) might reduce the nonmeasles mortality rate more than 1 dose of MV does. The effect of 2 versus 1 dose on morbidity has not been examined. Within a randomized trial of the effect of 2 doses versus 1 dose of MV on mortality in Guinea-Bissau, we...... measles vaccination policy might reduce hospital admissions more than the current policy of providing the first MV at 9 months of age. Trial registration: ClinicalTrials.gov identifier NCT00168558....
Onoue, Takeshi; Goto, Motomitsu; Kobayashi, Tomoko; Tominaga, Takashi; Ando, Masahiko; Honda, Hiroyuki; Yoshida, Yasuko; Tosaki, Takahiro; Yokoi, Hisashi; Kato, Sawako; Maruyama, Shoichi; Arima, Hiroshi
The Internet of Things (IoT) allows collecting vast amounts of health-relevant data such as daily activity, body weight (BW), and blood pressure (BP) automatically. The use of IoT devices to monitor diabetic patients has been studied, but could not evaluate IoT-dependent effects because health data were not measured in control groups. This multicenter, open-label, randomized, parallel group study will compare the impact of intensive health guidance using IoT and conventional medical guidance on glucose control. It will be conducted in outpatients with type 2 diabetes for a period of 6 months. IoT devices to measure amount of daily activity, BW, and BP will be provided to IoT group patients. Healthcare professionals (HCPs) will provide appropriate feedback according to the data. Non-IoT control, patients will be given measurement devices that do not have a feedback function. The primary outcome is glycated hemoglobin at 6 months. The study has already enrolled 101 patients, 50 in the IoT group and 51 in the non-IoT group, at the two participating outpatient clinics. The baseline characteristics of two groups did not differ, except for triglycerides. This will be the first randomized, controlled study to evaluate IoT-dependent effects of intensive feedback from HCPs. The results will validate a new method of health-data collection and provision of feedback suitable for diabetes support with increased effectiveness and low cost.
Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W
Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or
Kong, Angela; Buscemi, Joanna; Stolley, Melinda R.; Schiffer, Linda A.; Kim, Yoonsang; Braunschweig, Carol L.; Gomez-Perez, Sandra L.; Blumstein, Lara B.; Van Horn, Linda; Dyer, Alan R.; Fitzgibbon, Marian L.
Introduction The preschool years provide a unique window of opportunity to intervene on obesity-related lifestyle risk factors during the formative years of a child’s life. The purpose of this study was to assess the impact of a preschool-based obesity prevention effectiveness trial at 1-year follow-up. Design RCT. Settings/participants Primarily African American children (aged 3–5 years, N=618) attending Head Start preschool programs administered by Chicago Public Schools. Methods Eighteen preschools were randomly assigned in 2007–2008 to receive either: (1) a 14-week teacher-delivered intervention focused on healthy lifestyle behaviors; or (2) a 14-week teacher-delivered general health curriculum (control group). Main outcome measures The primary outcome, BMI, was measured at baseline, post-intervention, and 1-year follow-up. Diet and screen time behaviors were also assessed at these time points. Multilevel mixed effects models were used to test for between-group differences. Data were analyzed in 2014. Results Significant between-group differences were observed in diet, but not in BMI z-score or screen time at 1-year follow-up. Diet differences favored the intervention arm over controls in overall diet quality (p=0.02) and in subcomponents of diet quality, as measured by the Healthy Eating Index-2005, and in fruit intake (servings/day, excludes juice) (p=0.02). Diet quality worsened more among controls than the intervention group at 1-year follow-up. Conclusions The adaptation of Hip-Hop to Health Jr. produced modest benefits in diet quality, but did not significantly impact weight gain trajectory. Not unlike other effectiveness trials, this real-world version delivered by Head Start teachers produced fewer benefits than the more rigorous efficacy trial. It is important to understand and build upon the lessons learned from these types of trials so that we can design, implement, and disseminate successful evidence-based programs more widely and effectively
Kamioka, Hiroharu; Tsutani, Kiichiro; Okuizumi, Hiroyasu; Mutoh, Yoshiteru; Ohta, Miho; Handa, Shuichi; Okada, Shinpei; Kitayuguchi, Jun; Kamada, Masamitsu; Shiozawa, Nobuyoshi; Honda, Takuya
Background: The objective of this review was to summarize findings on aquatic exercise and balneotherapy and to assess the quality of systematic reviews based on randomized controlled trials.Methods...
Mérol, Jean-Claude; Charpiot, Anne; Langagne, Thibault; Hémar, Patrick; Ackerstaff, Annemieke H.; Hilgers, Frans J. M.
Objectives/Hypothesis: Assessment of immediate postoperative airway humidification after total laryngectomy (TLE), comparing the use of an external humidifier (EH) with humidification through a heat and moisture exchanger (HME). Study Design: Randomized controlled trial (RCT). Methods: Fifty-three
Mérol, J.-C.; Charpiot, A.; Langagne, T.; Hémar, P.; Ackerstaff, A.H.; Hilgers, F.J.M.
Objectives/Hypothesis: Assessment of immediate postoperative airway humidification after total laryngectomy (TLE), comparing the use of an external humidifier (EH) with humidification through a heat and moisture exchanger (HME). Study Design: Randomized controlled trial (RCT). Methods: Fifty-three
Pedersen, Jesper H; Ashraf, Haseem; Dirksen, Asger
INTRODUCTION: Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway. METHODS: In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either...... lung cancer. Ten of these had stage I disease. Eleven of 17 lung cancers at baseline were treated surgically, eight of these by video assisted thoracic surgery resection. CONCLUSIONS: Screening may facilitate minimal invasive treatment and can be performed with a relatively low rate of false......-positive screen results compared with previous studies on lung cancer screening....
Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe
Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037
Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E
acknowledged as the study design of choice for comparing treatment effects, as they eliminate several sources of bias. We propose a framework for the design and conduct of future randomized clinical trials that will offer strong scientific evidence for the effectiveness of wound care interventions. While......The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low. Randomized clinical trials are universally....... This article proposes strategies for improving the evidence base for wound care decision making....
Assessing the effect of culturally specific audiovisual educational interventions on attaining self-management skills for chronic obstructive pulmonary disease in Mandarin- and Cantonese-speaking patients: a randomized controlled trial.
Poureslami, Iraj; Kwan, Susan; Lam, Stephen; Khan, Nadia A; FitzGerald, John Mark
Patient education is a key component in the management of chronic obstructive pulmonary disease (COPD). Delivering effective education to ethnic groups with COPD is a challenge. The objective of this study was to develop and assess the effectiveness of culturally and linguistically specific audiovisual educational materials in supporting self-management practices in Mandarin- and Cantonese-speaking patients. Educational materials were developed using participatory approach (patients involved in the development and pilot test of educational materials), followed by a randomized controlled trial that assigned 91 patients to three intervention groups with audiovisual educational interventions and one control group (pamphlet). The patients were recruited from outpatient clinics. The primary outcomes were improved inhaler technique and perceived self-efficacy to manage COPD. The secondary outcome was improved patient understanding of pulmonary rehabilitation procedures. Subjects in all three intervention groups, compared with control subjects, demonstrated postintervention improvements in inhaler technique (Pmanage a COPD exacerbation (Pmanaging COPD (Pmanagement practices. Self-management education led to improved proper use of medications, ability to manage COPD exacerbations, and ability to achieve goals in managing COPD. A relatively simple culturally appropriate disease management education intervention improved inhaler techniques and self-management practices. Further research is needed to assess the effectiveness of self-management education on behavioral change and patient empowerment strategies.
Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial
Achenbach, Stephan [Friedrich-Alexander-Universitaet Erlangen-Nuernberg, Department of Cardiology, Erlangen (Germany); Paul, Jean-Francois [Centre Chirurgical Marie Lannelongue, Department of Radiology, Le Plessis Robinson (France); Laurent, Francois [University of Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, U1045, Bordeaux (France); CHU de Bordeaux, Service d' Imagerie Thoracique et Cardiovasculaire, Pessac (France); Becker, Hans-Christoph [University Hospital Grosshadern, Department of Clinical Radiology, Munich (Germany); Rengo, Marco [Sapienza - University of Rome, ICOT Hospital, Department of Radiological Sciences, Oncology and Pathology, Latina (Italy); Caudron, Jerome [University Hospital of Rouen, Department of Radiology, Rouen (France); Leschka, Sebastian [Saint Gallen Hospital, Department of Radiology, Saint Gallen (Switzerland); Vignaux, Olivier [Cochin Hospital, Department of Radiology, Paris (France); Knobloch, Gesine [La Charite, Department of Radiology, Berlin (Germany); Benea, Giorgio [Ospedale del Delta, Ferrara (Italy); Schlosser, Thomas [Elisabeth-Krankenhaus Hospital, Essen (Germany); Andreu, Jordi [Hospital Vall d' Hebron, Barcelona (Spain); Cabeza, Beatriz [Hospital Clinico San Carlos, Madrid (Spain); Jacquier, Alexis [La Timone Adult Hospital, Department of Radiology, Marseille (France); Souto, Miguel [Complejo Hospitalario Universitario, Santiago de Compostela (Spain); Revel, Didier [Louis Pradel Hospital, Department of Radiology, Lyon (France); Qanadli, Salah Dine [University of Lausanne, Department of Radiology, Lausanne (Switzerland); Cademartiri, Filippo [Giovanni XXIII Hospital, Department of Radiology, Monastier di Treviso (Italy); Collaboration: X-ACT Study Group
To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. (orig.)
Jiang, Xijun; Liu, He; Peng, Chufang
Recent reviews confirm a general lack of randomized, controlled clinical studies on the efficacy of regenerative endodontics in immature teeth affected by pulp and periapical diseases. Moreover, we have no evidence of the curative efficacy of collagen membranes used as scaffolds in regenerative endodontics. Here, we evaluated whether a Bio-Gide collagen membrane (Geistlich Pharma AG, Wolhusen, Switzerland) has efficacy in promoting dentin formation in regenerative endodontics. Forty-three patients yielding a total of 46 nonvital immature teeth were divided randomly into 2 groups. Subsequent to chemomechanical preparation, regenerative endodontics with (the experimental group) and without (the control group) Bio-Gide were performed. All cases were followed up clinically and radiographically every 3 months for at least 6 months. Quantitative analyses using an imaging program yielded percentage changes in root dimensions based on a comparison between preoperative and recall radiographs. The results of 40 patients (43 teeth) were included in the final analyses. All patients from both groups showed clinical success with complete resolution of signs and symptoms. Radiographically, the thickness of the dentin wall at the middle third of the root was higher for the experimental group than the control group. However, other indicators were comparable between both groups. The use of the Bio-Gide collagen membrane promoted the development of the dentin wall in the middle third of the root in patients undergoing regenerative endodontic procedures. The convenience of operation and the assured positioning of the sealing material make the Bio-Gide collagen membrane especially suitable for handling wide root canals. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.
Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is
Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D
Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is
Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.
Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis
Ge, Weiqing; Leson, Chelsea; Vukovic, Corey
[Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59?years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome...
Klimt, C R
Some of the guiding principles as well as the pitfall of long-term randomized clinical trials are presented. Examples have been chosen from trials in the cardiovascular field. A typical long-term clinical trial is divided into five phases: planning, preparation, recruitment, clinical follow-up and termination, and finally analysis. Administrative, legal, and ethical aspects of a trial are discussed, as well as the cost of clinical trials. Organization patterns are described and some prevalent ones are criticized. Further, practical matters such as recruitment techniques, obtaining informed consent from the patients, determining drug dosage and formulation as well as the problem of interaction with nonstudy drugs are referred to. Adherence testing remains a problem, because of our inability to test for placebo adherence.
Vollenweider, Daniela; Ebneter, Ingrid; Mayer, Dieter; Hafner, Jürg; Steurer, Johann; Puhan, Milo A
Chronic wounds have a great variety of etiologies and manifestations that influence wound healing. Such heterogeneity potentially threatens the validity and clinical usefulness of trials if not considered appropriately. In 82 randomized wound trials retrieved from 10 Cochrane reviews, we assessed if and how authors considered wound and other prognostically important characteristics in the conduct and analysis of wound trials. We assessed whether these characteristics were discussed, reflected in the eligibility criteria, used for prestratification or for adjustments to ensure comparability of treatment groups, and whether subgroup analyses were conducted to identify heterogeneity of treatment effects. Nine percent of all trials explicitly discussed characteristics that influence wound healing in the introduction and 43% in the Discussion section. Ninety percent of trials had at least one prognostically important characteristic as eligibility criterion. Only 11% of trials used prestratification, and 6% adjusted the results for imbalances between treatment groups. Twenty-seven percent performed subgroup analyses with prognostically important characteristics defining subgroups. Chronic wound trials use simple randomization, but rarely adapt the study design and analysis to take the heterogeneity of patients into consideration. Collaborative multicenter trials would overcome many of the limitations and provide statistical power to detect important treatment effects both overall and in subgroups. © 2012 by the Wound Healing Society.
The life in sight application study (LISA): design of a randomized controlled trial to assess the role of an assisted structured reflection on life events and ultimate life goals to improve quality of life of cancer patients
Kruizinga, Renske; Scherer-Rath, Michael; Schilderman, Johannes B. A. M.; Sprangers, Mirjam A. G.; van Laarhoven, Hanneke W. M.
It is widely recognized that spiritual care plays an important role in physical and psychosocial well-being of cancer patients, but there is little evidence based research on the effects of spiritual care. We will conduct a randomized controlled trial on spiritual care using a brief structured
Findings from the SASA! Study: a cluster randomized controlled trial to assess the impact of a community mobilization intervention to prevent violence against women and reduce HIV risk in Kampala, Uganda.
Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Nakuti, Janet; Kyegombe, Nambusi; Starmann, Elizabeth; Cundill, Bonnie; Francisco, Leilani; Kaye, Dan; Musuya, Tina; Michau, Lori; Watts, Charlotte
Intimate partner violence (IPV) and HIV are important and interconnected public health concerns. While it is recognized that they share common social drivers, there is limited evidence surrounding the potential of community interventions to reduce violence and HIV risk at the community level. The SASA! study assessed the community-level impact of SASA!, a community mobilization intervention to prevent violence and reduce HIV-risk behaviors. From 2007 to 2012 a pair-matched cluster randomized controlled trial (CRT) was conducted in eight communities (four intervention and four control) in Kampala, Uganda. Cross-sectional surveys of a random sample of community members, 18- to 49-years old, were undertaken at baseline (n = 1,583) and four years post intervention implementation (n = 2,532). Six violence and HIV-related primary outcomes were defined a priori. An adjusted cluster-level intention-to-treat analysis compared outcomes in intervention and control communities at follow-up. The intervention was associated with significantly lower social acceptance of IPV among women (adjusted risk ratio 0.54, 95% confidence interval (CI) 0.38 to 0.79) and lower acceptance among men (0.13, 95% CI 0.01 to 1.15); significantly greater acceptance that a woman can refuse sex among women (1.28, 95% CI 1.07 to 1.52) and men (1.31, 95% CI 1.00 to 1.70); 52% lower past year experience of physical IPV among women (0.48, 95% CI 0.16 to 1.39); and lower levels of past year experience of sexual IPV (0.76, 95% CI 0.33 to 1.72). Women experiencing violence in intervention communities were more likely to receive supportive community responses. Reported past year sexual concurrency by men was significantly lower in intervention compared to control communities (0.57, 95% CI 0.36 to 0.91). This is the first CRT in sub-Saharan Africa to assess the community impact of a mobilization program on the social acceptability of IPV, the past year prevalence of IPV and levels of sexual concurrency. SASA
Tonguet-Papucci, Audrey; Huybregts, Lieven; Ait Aissa, Myriam; Huneau, Jean-François; Kolsteren, Patrick
Wasting is a public health issue but evidence gaps remain concerning preventive strategies not primarily based on food products. Cash transfers, as part of safety net approach, have potential to prevent under-nutrition. However, most of the cash transfer programs implemented and scientifically evaluated do not have a clear nutritional objective, which leads to a lack of evidence regarding their nutritional benefits. The MAM'Out research project aims at evaluating a seasonal and multiannual cash transfer program to prevent acute malnutrition in children under 36 months, in terms of effectiveness and cost-effectiveness in the Tapoa province (Eastern region of Burkina Faso, Africa). The program is targeted to economically vulnerable households with children less than 1 year old at the time of inclusion. Cash is distributed to mothers and the transfers are unconditional, leading to beneficiaries' self-determination on the use of cash. The study is designed as a two-arm cluster randomized intervention trial, based on the randomization of rural villages. One group receives cash transfers via mobile phones and one is a control group. The main outcomes are the cumulative incidence of acute malnutrition and the cost-effectiveness. Child anthropometry (height, weight and MUAC) is followed, as well as indicators related to dietary diversity, food security, health center utilization, families' expenses, women empowerment and morbidities. 24 h-food recalls are also carried out. Individual interviews and focus group discussions allow collecting qualitative data. Finally, based on a theory framework built a priori, the pathways used by the cash to have an effect on the prevention of under-nutrition will be assessed. The design chosen will lead to a robust assessment of the effectiveness of the proposed intervention. Several challenges appeared while implementing the study and discrepancies with the research protocol, mainly due to unforeseen events, can be highlighted, such as
H.B. Dupont (Hans B.); M.J.J.M. Candel (Math); Ch.D. Kaplan; H. van de Mheen (Dike); N.K. de Vries (Nanne)
textabstractThe Moti-4 intervention, in which motivational interviewing, self-monitoring, and strengthening behavioral control are used, was developed in the Netherlands in response to several rapid assessments of problematic use of cannabis among vulnerable adolescents. The main goal of the study
Nørskov, A K; Wetterslev, J; Rosenstock, C V
BACKGROUND: Unanticipated difficult intubation remains a challenge in anaesthesia. The Simplified Airway Risk Index (SARI) is a multivariable risk model consisting of seven independent risk factors for difficult intubation. Our aim was to compare preoperative airway assessment based on the SARI w...
Neal, Bruce; Perkovic, Vlado; Matthews, David R.; Mahaffey, Kenneth W.; Fulcher, Greg; Meininger, Gary; Erondu, Ngozi; Desai, Mehul; Shaw, Wayne; Vercruysse, Frank; Yee, Jacqueline; Deng, Hsiaowei; de Zeeuw, Dick
Aims: The primary aim of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R) is to determine whether the favourable effects of inhibition of the sodium glucose co-transporter 2 (SGLT2) on blood glucose, blood pressure and body weight are accompanied by protection against adverse renal
Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda
Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de
Baker, Philip R A; Francis, Daniel P; Cathcart, Abby
The study's objective was to apply and assess an active learning approach to epidemiology and critical appraisal. Active learning comprised a mock, randomized controlled trial (RCT) conducted with learners in 3 countries. The mock trial consisted of blindly eating red Smarties candy (intervention) compared to yellow Smarties (control) to determine whether red Smarties increase happiness. Audience response devices were employed with the 3-fold purposes to produce outcome data for analysis of the effects of red Smarties, identify baseline and subsequent changes in participant's knowledge and confidence in understanding of RCTs, and assess the teaching approach. Of those attending, 82% (117 of 143 learners) participated in the trial component. Participating in the mock trial was a positive experience, and the use of the technology aided learning. The trial produced data that learners analyzed in "real time" during the class. The mock RCT is a fun and engaging approach to teaching RCTs and helping students to develop skills in critical appraisal.
Bjørndal, Lars; Fransson, Helena; Bruun, Gitte
nonselective carious removal to hard dentin with or without pulp exposure. The aim of this article was to report the 5-y outcome on these previously treated patients having radiographically well-defined carious lesions extending into the pulpal quarter of the dentin but with a well-defined radiodense zone...... between the carious lesion and the pulp. In this long-term study, 239 of 314 (76.2%) patients were analyzed. The stepwise removal group had a significantly higher proportion of success (60.2%) at 5-y follow-up compared with the nonselective carious removal to hard dentin group (46.3%) (P = 0.031) when......) in deep carious lesions in adults. In conclusion, the stepwise carious removal group had a significantly higher proportion of pulps with sustained vitality without apical radiolucency versus nonselective carious removal of deep carious lesions in adult teeth at 5-y follow-up (ClinicalTrials.gov NCT...
A randomized, double blind, cross-over, placebo-controlled clinical trial to assess the effects of Candesartan on the insulin sensitivity on non diabetic, non hypertense subjects with dysglyce mia and abdominal obesity. "ARAMIA"
Rueda-Clausen Christian F
Full Text Available Abstract Background The raising prevalence of type-2 diabetes mellitus and obesity has been recognized as a major problem for public health, affecting both developed and developing countries. Impaired fasting plasma glucose has been previously associated with endothelial dysfunction, higher levels of inflammatory markers and increased risk of developing insulin resistance and cardiovascular events. Besides life-style changes, the blockade of the renin-angiotensin system has been proposed as a useful alternative intervention to improve insulin resistance and decrease the number of new type-2 diabetes cases. The aim of this clinical trial is to study the effect of the treatment with Candesartan, an angiotensin II receptor antagonist, on the insulin resistance, the plasma levels of adipoquines, oxidative stress and prothrombotic markers, in a group of non diabetic, non hypertensive, dysglycemic and obese subjects. Methods and design A randomized, double blind, cross-over, placebo-controlled, clinical trial was designed to assess the effects of Candesartan (up to 32 mg/day during 6 months on the Homeostasis Model Assessment (HOMA index, lipid profile, protrombotic state, oxidative stress and plasma levels of inflammatory markers. The participants will be recruited in the "Fundación Cardiovascular de Colombia". Subjects who fullfil selection criteria will receive permanent educational, nutritional and exercise support during their participation in the study. After a 15 days-run-in period with placebo and life-style recommendations, the patients who have a treatment compliance equal or greater than 80% will be randomlly assigned to one of the treatment groups. Group A will receive Candesartan during 6 months and placebo during 6 months. Group B will receive placebo during the first 6 months, and then, Candesartan during the last 6 months. Control visits will be programed monthly and all parameters of interest will be evaluated every 6 months
Silva de Oliveira, Júlio César; Grossi de Oliveira, Gustavo Augusto; Bassi, Ana Paula Farnezi
To compare the efficacy of ibuprofen (IBU) and etodolac (ETO) for controlling pain, edema, and trismus after extraction of lower third molars. Twenty adolescents and adults with 2 impacted mandibular-third molars (in similar positions) were selected for the study. Patients were randomly assigned either to the IBU group (600 mg of IBU 3 times a day for 3 days) or to the ETO group (300 mg of ETO 3 times a day for 3 days). Drugs were administered immediately after dental extraction. During the first 2 days after extraction, swelling was more pronounced in the IBU group than in the ETO group (P = .033). Seven days after surgery, there was no difference in the degree of edema between the groups. At the 2- and 7-day evaluation points, mouth opening was significantly more reduced in the IBU group than in the ETO group (P trismus, and pain were more effectively controlled with ETO than with IBU. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.
Effect of routine assessment of specific psychosocial problems on personalized communication, counselors’ awareness, and distress levels in cancer genetic counseling practice: a randomized controlled trial.
Eijzenga, Willem; Aaronson, Neil K; Hahn, Daniela E E; Sidharta, Grace N; van der Kolk, Lizet E; Velthuizen, Mary E; Ausems, Margreet G E M; Bleiker, Eveline M A
This study evaluated the efficacy of a cancer genetics–specific questionnaire in facilitating communication about, awareness of, and management of psychosocial problems, as well as in lowering distress levels. Individuals referred to genetic counseling for cancer at two family cancer clinics in The Netherlands were randomly assigned to an intervention or a control group. All participants completed the psychosocial questionnaire before counseling. In the intervention group, the counselors received the results of this questionnaire before the counseling session. All sessions were audiotaped for content analysis. Primary outcomes were the frequency with which psychosocial problems were discussed, the genetic counselors’ awareness of these problems, and their management. Secondary outcomes included cancer worries and psychological distress, duration and dynamics of the counseling, and satisfaction. The frequency with which psychosocial problems were discussed with 246 participating counselees was significantly higher in the intervention group (n = 127) than in the control group (n =119; P = .004), as was the counselors’ awareness of psychosocial problems regarding hereditary predisposition (P problems in the intervention group (P problems by questionnaire facilitates genetic counselors’ recognition and discussion of their clients’ psychosocial problems and reduces clients’ distress levels.
Sindrup, Søren Hein; Konder, R; Lehmann, R
GRT9906 is an investigational novel compound with μ-opioid receptor agonism and inhibition of noradrenalin/serotonin re-uptake. In this randomized, double-blind, placebo-controlled, three-way cross-over trial in painful polyneuropathy, the efficacy and safety of GRT9906 was assessed and compared...
de Graaf, I. M.; Oude Rengerink, K.; Wiersma, I. C.; Donker, M. E.; Mol, B. W.; Pajkrt, E.
Objective: It is unclear which technique for skin closure should be used at caesarean section (CS) in order to get the best cosmetic result. Study design: We conducted a randomized controlled trial to assess the cosmetic result of different techniques for skin closure after CS. A two-center
Mandell, David S; Stahmer, Aubyn C; Shin, Sujie; Xie, Ming; Reisinger, Erica; Marcus, Steven C
This randomized field trial comparing Strategies for Teaching based on Autism Research and Structured Teaching enrolled educators in 33 kindergarten-through-second-grade autism support classrooms and 119 students, aged 5-8 years in the School District of Philadelphia. Students were assessed at the beginning and end of the academic year using the…
Vierhout, Bastiaan P.; Ott, Alewijn; Reijnen, Michel M. P. J.; Oskam, Jacques; Ott, Alewijn; van den Dungen, Jan J. A. M.; Zeebregts, Clark J.
Background: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a
Biegel, Gina M.; Brown, Kirk Warren; Shapiro, Shauna L.; Schubert, Christine M.
Research has shown that mindfulness-based treatment interventions may be effective for a range of mental and physical health disorders in adult populations, but little is known about the effectiveness of such interventions for treating adolescent conditions. The present randomized clinical trial was designed to assess the effect of the…
ter Riet, G.; Kessels, A. G.; Knipschild, P. G.
The objective of this study was to assess the effects of ascorbic acid supplementation, 500 mg twice daily in the treatment of pressure ulcers as an adjunct to standardized treatment. The design consisted of a multicenter blinded randomized trial. The control group received 10 mg of ascorbic acid
Stice, Eric; Shaw, Heather; Burton, Emily; Wade, Emily
In this trial, adolescent girls with body dissatisfaction (N = 481, M age = 17 years) were randomized to an eating disorder prevention program involving dissonance-inducing activities that reduce thin-ideal internalization, a prevention program promoting healthy weight management, an expressive writing control condition, or an assessment-only…
Rossen, Noortje G.; Fuentes, Susana; van der Spek, Mirjam J.; Tijssen, Jan G.; Hartman, Jorn H. A.; Duflou, Ann; Löwenberg, Mark; van den Brink, Gijs R.; Mathus-Vliegen, Elisabeth M. H.; de Vos, Willem M.; Zoetendal, Erwin G.; D'Haens, Geert R.; Ponsioen, Cyriel Y.
Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial. Patients with mild to moderately active UC (n = 50) were assigned to groups that
Rossen, N.G.; Fuentes Enriquez de Salamanca, S.; Spek, van der M.J.; Tijssen, J.; Hartman, J.H.A.; Duflou, A.; Löwenberg, M.; Brink, van den G.R.; Mathus-Vliegen, E.M.; Vos, de W.M.; Zoetendal, E.G.; Haens, D' G.R.; Ponsioen, C.Y.
BACKGROUND: & Aims: Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial. METHODS: Patients with mild to moderately active UC (n=50)
Lee, Myeong Soo; Choi, Tae-Young; Shin, Byung-Cheul; Ernst, Edzard
This study aimed to assess the effectiveness of acupuncture as a treatment for autism spectrum disorders (ASD). We searched the literature using 15 databases. Eleven randomized clinical trials (RCTs) met our inclusion criteria. Most had significant methodological weaknesses. The studies' statistical and clinical heterogeneity prevented us from…
Ebbels, Susan H.; van der Lely, Heather K. J.; Dockrell, Julie E.
Purpose: The authors aimed to establish whether 2 theoretically motivated interventions could improve use of verb argument structure in pupils with persistent specific language impairment (SLI). Method: Twenty-seven pupils with SLI (ages 11;0-16;1) participated in this randomized controlled trial with "blind" assessment. Participants were randomly…
Gijsbers, L.; Moelenberg, F. J. M.; Bakker, S. J. L.; Geleijnse, J. M.
Background and aims: Increasing the intake of potassium has been shown to lower blood pressure, but whether it also affects heart rate (HR) is largely unknown. We therefore assessed the effect of potassium supplementation on HR in a meta-analysis of randomized controlled trials. Methods and results:
Alves, Luana Severo; Giongo, Fernanda Cristina Mendes de Santa; Mua, Bruna
This randomized clinical trial aimed to assess the efficacy of sealing occlusal carious lesions in permanent teeth. The sample consisted of 54 occlusal carious lesions in permanent molars and premolars of 49 patients aged 8-43 years (median: 19 years). The inclusion criteria comprised the presenc...
Full Text Available Our study aimed to assess the impact of a six-months nutrition program, taught by trained teachers, on fruit and vegetable consumption among children in grades 1 to 4. Four hundred and sixty-four children (239 female, 6 to 12 years old, from seven elementary schools were assigned to this randomized trial. Teachers were trained by researchers over six months, according to the following topics: nutrition, healthy eating, and strategies to increase physical activity. After each session, teachers were encouraged to develop activities in the classroom on the topics learned. Children's sociodemographic, anthropometric, dietary, and physical activity data were assessed at baseline and at the end of the intervention. The effect sizes ranged between small (Cohen's d=0.12 on “other vegetables” to medium (0.56 on “fruit and vegetable”, and intervened children reported a significantly higher consumption of vegetables and fruit. Interventions involving trained teachers offer promise to increase consumption of fruit and vegetable in children.
Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial
Suijker Jacqueline J; Buurman Bianca M; ter Riet Gerben; van Rijn Marjon; de Haan Rob J; de Rooij Sophia E; Moll van Charante Eric P
Abstract Background Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this study is to investigate whether functional decline in community-dwelling older persons can be delayed or prevented by a comprehensive geriatric assessment, multifactorial interventions and n...
Llewellyn-Bennett, Rebecca; Bowman, Louise; Bulbulia, Richard
Clinical trials typically have a relatively short follow-up period, and may both underestimate potential benefits of treatments investigated, and fail to detect hazards, which can take much longer to emerge. Prolonged follow-up of trial participants after the end of the scheduled trial period can provide important information on both efficacy and safety outcomes. This protocol describes a systematic review to qualitatively compare methods of post-trial follow-up used in large randomized controlled trials. A systematic search of electronic databases and clinical trial registries will use a predefined search strategy. All large (more than 1000 adult participants) randomized controlled trials will be evaluated. Two reviewers will screen and extract data according to this protocol with the aim of 95% concordance of papers checked and discrepancies will be resolved by a third reviewer. Trial methods, participant retention rates and prevalence of missing data will be recorded and compared. The potential for bias will be evaluated using the Cochrane Risk of Bias tool (applied to the methods used during the in-trial period) with the aim of investigating whether the quality of the post-trial follow-up methodology might be predicted by the quality of the methods used for the original trial. Post-trial follow-up can provide valuable information about the long-term benefits and hazards of medical interventions. However, it can be logistically challenging and costly. The aim of this systematic review is to describe how trial participants have been followed-up post-trial in order to inform future post-trial follow-up designs. Not applicable for PROSPERO registration.
Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N
Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.
Li, Roger; Ruckle, Herbert C; Creech, Jon D; Culpepper, David J; Lightfoot, Michelle A; Alsyouf, Muhannad; Nicolay, Lesli; Jellison, Forrest; Baldwin, D Duane
The effect of oral anxiolytics in diminishing patient discomfort and pain perception has been demonstrated in GI endoscopy, percutaneous coronary interventions, and various procedures in the emergency department setting, but has not been prospectively studied in the setting of prostate biopsy. The purpose of this study was to investigate the effect of diazepam on pain perception during and after prostate biopsy. Sixty patients undergoing prostate biopsy at a single academic institution were enrolled into a prospective, randomized, placebo-controlled study. A questionnaire was administered prebiopsy to determine baseline discomfort and pain history. A visual analog pain scale was used to determine pain associated with each step of the transrectal Ultrasonography-guided prostate biopsy and was administered 20 minutes after biopsy and 1 week later. Responses were compared between groups using the Mann-Whitney U test, Fisher exact test, and Wilcoxon signed rank test as appropriate. A total of 60 patients (29 diazepam, 31 placebo) completed pre- and postbiopsy surveys for analysis. The number of cores sampled during biopsy was controlled during analysis and was found to have no correlation with total pain measured. There were no differences between diazepam and placebo groups in age, prebiopsy survey results, immediate and 1 week postbiopsy survey results. There was no difference in the patients' willingness to undergo a repeated procedure in the control and treatment groups. Complications of taking diazepam prebiopsy included drowsiness, chills, and ankle injury. Diazepam does not improve patient pain perception immediately after or at 1-week recall after prostate biopsy. Omitting diazepam simplifies the biopsy regimen and allows the patient to drive himself home. Based on these results, routine use of diazepam in prostate biopsy is not recommended.
MRI assessment of erosion repair in patients with long-standing rheumatoid arthritis receiving double-filtration plasmapheresis in addition to leflunomide and methotrexate: a randomized controlled trial.
Yu, Xiaoxia; Zhang, Lei; Wang, Lixin; Lu, Weiwei; Sun, Fengyan; Xu, Ping; Lan, Guobin
The objective of this study is to investigate whether the addition of double-filtration plasmapheresis (DFPP) to leflunomide and methotrexate repairs MRI bone erosion in patients with long-standing rheumatoid arthritis (RA). Seventy-two patients with highly active RA of > 3 years' duration were randomized to receive DFPP in addition to DMARDs (leflunomide and methotrexate) or DMARDs. Contrast-enhanced MRI of the right wrist was performed at months 0, 6, and 12. MRI bone erosion, synovitis, and bone edema were scored with validated methods. The primary endpoint was the change in MRI bone erosion over 12 months. Patients treated with DFPP in addition to DMARDs demonstrated significantly greater decrease in MRI erosion score compared with those treated with DMARDs, being 11.3 ± 9.6 at month 12, compared with 16.9 ± 8.3 in patients with DMARDs (P erosion score. Synovitis and bone edema improved significantly with DFPP in addition to DMARDs compared with DMARDs at months 6 and 12. (1.05 ± 1.7 and 2.0 ± 3.9 compared with 8.0 ± 1.4 and 12.6 ± 7.9 at month 12). Patients without synovitis and bone edema reached in 55.3% among patients with DFPP in addition to DMARDs. This study demonstrated that DFPP combination therapy significantly decreased bone erosion and received the primary goal of repair of erosions through abrogating MRI inflammation (synovitis and bone edema) in long-standing RA patients with high disease activity. The findings suggest that addition of DFPP is associated with repair of erosions and further suppression of inflammation.
Chou, Lin-Chuan; Liou, Tsan-Hon; Kuan, Yi-Chun; Huang, Yao-Hsien; Chen, Hung-Chou
To appraise existing evidence of autologous blood injection in treating lateral epicondylosis. Meta-analysis of randomized controlled trials. A comprehensive search of the PubMed, Cochrane, SCOPUS, and CINAHL databases was performed to identify randomized controlled trials that reported the efficacy of autologous blood injection in treating lateral epicondylosis. The selected studies were subjected to a meta-analysis and risk of bias assessment. Patients with lateral epicondylosis. Pain-related measurement in each selected randomized controlled trial was pooled into meta-analysis. Nine randomized controlled trials were included in the analysis. The results of the meta-analysis including the pain scores indicated that autologous blood injection is more effective compared with corticosteroid injection (standard mean difference: -0.75; 95% confidence interval: -1.14 to -0.37) but not more effective compared with platelet-rich plasma injection (standard mean difference: 0.09; 95% confidence interval: -0.66 to 0.84). The risk of bias assessment indicated that all the included trials exhibited a moderate to high risk of bias. Autologous blood injection is more effective than corticosteroid injection but not more effective than platelet-rich plasma injection in treating lateral epicondylosis. However, this evidence is limited by the potential risk of bias. Copyright © 2015 Elsevier Ltd. All rights reserved.
Traumatic Stress Disorder (PTSD) and related psychological health difficulties in Veterans and military personnel who suffer from these problems. To meet...therapy (CBT) Post-Traumatic Stress Disorder (PTSD) Randomized controlled trial (RCT) Standardized Patient (SP) ACCOMPLISHMENTS This section...were presented at the American Psychological Association (APA) 2016 Convention in August 2016. iii. A Symposium will be presented at the International
A Randomized Controlled Trial Study on the Effect of Adding Dexmedetomidine to Bupivacaine in Supraclavicular Block Using Ultrasound Guidance. ... BACKGROUND: The benefits of regional anesthetic techniques are well established. Use of additives to local anesthetics can prolong these benefits. The aim of this study ...