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Editorial BoardEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 26, 2009 Category: Radiology Source Type: journals

SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findingsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: To the best of our knowledge, the SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper records. This study has the potential to reveal significant details about self-monitoring patterns and whether technology can improve adherence to this vital intervention component. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 4, 2009 Category: Radiology Authors: Lora E. Burke, Mindi A. Styn, Karen Glanz, Linda J. Ewing, Okan U. Elci, Margaret B. Conroy, Susan M. Sereika, Sushama D. Acharya, Edvin Music, Alison L. Keating, Mary Ann Sevick Tags: Study design, statistical design, study protocols Source Type: journals

Measurement and predictors of adherence in a trial of HSV suppressive therapy in TanzaniaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study estimates adherence and identifies predictors of good adherence among 1305 Tanzanian women participating in a randomised, double-blind, placebo-controlled trial of HSV suppressive therapy to reduce HIV incidence or genital HIV shedding. Women were randomised to acyclovir 400mg BD or placebo and followed every three months for 12–30months. Adherence was assessed by tablet counts. Random urine samples, collected between 6 and 24months, were tested for acyclovir. At 12, 24 and 30month visits, 56%, 52% and 54% of women on treatment had adherence ≥90%, respectively. Factors independently associated with good adhe...
Source: Contemporary Clinical Trials - September 1, 2009 Category: Radiology Authors: Deborah Watson-Jones, Kathy Baisley, Mary Rusizoka, Clare Tanton, Kokugonza Mugeye, Helen A Weiss, John Changalucha, Tim Clayton, Ian Hambleton, David A. Ross, Richard J Hayes Tags: Clinical trial management and optimization Source Type: journals

Attrition and retention in clinical trials by ethnic originEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Context: Common perceptions exist within the medical community that retention of Hispanics in clinical trials is difficult, albeit little data is available to support this conviction.Methods: A total of 541 randomly selected charts from closed clinical trials between 2000 and 2006 were reviewed. Records were from participating institutions in Texas Medical Center, Houston, and targeted diseases of high prevalence, specifically, breast cancer, prostate cancer, and chronic obstructive pulmonary disease (COPD)/asthma.Findings: Overall, 259 participants (48%) completed the trial they were enrolled in (44% whites, 69%...
Source: Contemporary Clinical Trials - August 21, 2009 Category: Radiology Authors: Haleh Sangi-Haghpeykar, Hannah M. Meddaugh, Hao Liu, Placido Grino Tags: Clinical trial management and optimization Source Type: journals

Editorial BoardEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 18, 2009 Category: Radiology Source Type: journals

Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigationsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: Randomized trials comparing the effects of different diagnostic alternatives on treatment outcomes pose study design challenges. A non-inferiority design is appropriate when comparing a less invasive and less expensive alternative with a standard of care approach. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 11, 2009 Category: Radiology Authors: Charles W. Nager, Linda Brubaker, Firouz Daneshgari, Heather J. Litman, Kimberly J. Dandreo, Larry Sirls, Gary E. Lemack, Holly E. Richter, Wendy Leng, Peggy Norton, Stephen R. Kraus, Toby C. Chai, Debuene Chang, Cindy L. Amundsen, Anne M. Stoddard, Sharo Tags: Study design, statistical design, study protocols Source Type: journals

Corrigendum to “A Multisite Trial of Mifepristone for the Treatment of Psychotic Depression: A Site-by-Treatment Interaction” [Contemp. Clin. Trials 30 (2009)284–288]Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The authors regret the typographical error in the penultimate sentence of the abstract. The sentence should read: “First, while statistical adjustments for site are common in multisite clinical trials, this study reminds trialists to formally evaluate the interaction of site by treatment.” (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 5, 2009 Category: Radiology Authors: Christine M. Blasey, Charles DeBattista, Robert Roe, Thaddeus Block, Joseph K. Belanoff Tags: Corrigendum Source Type: journals

Sensitivity of dose-finding studies to observation errorsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: The purpose of Phase I designs is to estimate the MTD (maximum tolerated dose, in practice a dose with some given acceptable rate of toxicity) while, at the same time, minimizing the number of patients treated at doses too far removed from the MTD. Our purpose here is to investigate the sensitivity of conclusions from dose-finding designs to recording or observation errors. Certain toxicities may go undetected and, conversely, certain non-toxicities may be incorrectly recorded as dose-limiting toxicities. Recording inaccuracies would be expected to have an influence on final and within trial recommendations and, ...
Source: Contemporary Clinical Trials - July 31, 2009 Category: Radiology Authors: Sarah Zohar, John O'Quigley Tags: Study design, statistical design, study protocols Source Type: journals

Informed consent documentation necessary but not sufficientEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Resnick has provided a very useful and succinct summary of some of the important ethical and legal reasons why informed consent documents (ICDs) cannot simply be replaced by conversations with study personnel as the chief vehicle for obtaining informed consent from research participants. We agree that in debate surrounding the shortcomings of existing procedures, strengths of ICDs (i.e. that they can serve as permanent record, include detailed information, can be reviewed by research ethics boards, serve a legal role) are often overlooked. We agree that documentation is an important component of informed consent. The probl...
Source: Contemporary Clinical Trials - July 26, 2009 Category: Radiology Authors: Jamie C. Brehaut, Raphael Saginur, Glyn Elwyn Tags: Letters to the Editor Source Type: journals

Recruiting minorities where they receive care: Institutional barriers to cancer clinical trials recruitment in a safety-net hospitalEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: Although we cannot determine from our qualitative data the relative impact of different kinds of barriers (e.g. patient, provider, institutional barriers), our data highlights the need to address the role of institutional barriers in efforts to improve minority recruitment to clinical trials. Recruiting participants in safety-net settings may be a reasonable strategy for increasing accrual of ethnic and racial minority patients to cancer clinical trials. However, our qualitative data suggest that while opening protocols for accrual at minority-serving institutions may signal nominal access to trials, achieving ...
Source: Contemporary Clinical Trials - July 22, 2009 Category: Radiology Authors: Galen Joseph, Daniel Dohan Tags: Patient recruitment Source Type: journals

Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSDEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study is enrolling approximately 126 returning veterans with current combat-related PTSD who are receiving services through the Veteran Administration (VA) mental health care clinics on 4 Hawaiian Islands. Cognitive Processing Therapy (CPT), an empirically supported manualized treatment for PTSD, is being delivered across 9 cohorts. Participants are assigned to either the experimental VTC condition or the in-person control condition. Assessments measuring clinical, process, and cost outcomes are being conducted at baseline, mid-treatment, post-treatment, and 3 and 6months post-treatment. The study employs a noninferio...
Source: Contemporary Clinical Trials - July 21, 2009 Category: Radiology Authors: Leslie A. Morland, Carolyn J. Greene, Craig Rosen, Patrick D. Mauldin, B. Christopher Frueh Tags: Study design, statistical design, study protocols Source Type: journals

Performance of five two-sample location tests for skewed distributions with unequal variancesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Tests for comparing the locations of two independent populations are associated with different null hypotheses, but results are often interpreted as evidence for or against equality of means or medians. We examine the appropriateness of this practice by investigating the performance of five frequently used tests: the two-sample T test, the Welch U test, the Yuen–Welch test, the Wilcoxon–Mann–Whitney test, and the Brunner–Munzel test. Under combined violations of normality and variance homogeneity, the true significance level and power of the tests depend on a complex interplay of several factors. In a wid...
Source: Contemporary Clinical Trials - July 20, 2009 Category: Radiology Authors: Morten W. Fagerland, Leiv Sandvik Tags: Study design, statistical design, study protocols Source Type: journals

Revisiting the level of evidence in randomized controlled clinical trials: A simulation approachEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: In RCTs, the hierarchy of confounding factors differs according to the type of blinding and the current short list of components of the strength of evidence (poorly concealed randomization and lack of blinding) appears to be incomplete. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 20, 2009 Category: Radiology Authors: Agathe Bajard, Sylvie Chabaud, David Pérol, Jean-Pierre Boissel, Patrice Nony Tags: Special interest paper Source Type: journals

Rationale, design, and sample characteristics of a randomized controlled trial of directly observed antiretroviral therapy delivered in methadone clinicsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: Our trial will allow rigorous evaluation of the efficacy of directly observed antiretroviral therapy delivered in methadone clinics for improving adherence and clinical outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among HIV-infected drug users receiving methadone for opioid dependence. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 5, 2009 Category: Radiology Authors: Karina M. Berg, Jennifer Mouriz, Xuan Li, Elise Duggan, Uri Goldberg, Julia H. Arnsten Tags: Study design, statistical design, study protocols Source Type: journals

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In Scoggins and Patrick we reported that 2482 (14.0%) of 17,704 interventional clinical trials registered in ClinicalTrials.gov between September 2004 and September 2007 used patient-reported outcome (PRO) instruments. Our search terms included “quality of life”, “qol”, “patient-reported outcome”, “health status”, “patient satisfaction”, and “psychometric”. We also searched for the names of 395 known PRO instruments. McEntegart wonders if the percentage is actually higher than 14.0%. He cites “diary” as an obvious omission from our search terms and lists “patients assessment”, “patients gl...
Source: Contemporary Clinical Trials - July 2, 2009 Category: Radiology Authors: John F. Scoggins, Donald L. Patrick Tags: Letters to the Editor Source Type: journals

Patient recruitment and retention: From art to scienceEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Patient recruitment and retention is a problem with a high impact in every clinical trial. A reasonable approach to address this problem is to conduct a feasibility study during protocol development to determine how the target patient population might react to the study design. However, more often than not, feasibility is not formally assessed. The minimum number of study subjects required per treatment group comes from the study statistician; then the duration of the recruitment period and the number of participating sites are determined, usually based on an educated guess rather than on solid data. If the initial recrui...
Source: Contemporary Clinical Trials - June 25, 2009 Category: Radiology Authors: Mikhail Rojavin Tags: Editorial Source Type: journals

Clinical translational research hits the road: RCT of breastfeeding promotion interventions in routine prenatal careEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Translating evidence-based research into practice requires data from clinical trials in real world settings. This paper presents “lessons learned” from the implementation of an RCT of breastfeeding promotion interventions at two busy, urban, prenatal care sites. Data were obtained via direct observations, qualitative interviews, and study statistics.Primary challenges include: time and space burdens, “research vs. service” mission conflict, and the provider learning curve for conducting interventions. Primary facilitators include: researcher presence for enhancing rapport with participants and staff, site...
Source: Contemporary Clinical Trials - June 23, 2009 Category: Radiology Authors: Karen A. Bonuck, Jennifer Lischewski, Mindy Brittner Tags: Clinical trial management and optimization Source Type: journals

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I found the article by Scoggins and Patrick informative. But I wonder whether the search terms used means the incidence of the use of patient-reported outcomes (PRO) might be underestimated? To recap, the authors searched clinicaltrials.gov for trial registrations that contained the terms “quality of life”, “qol”, “patient-reported outcome”, “health status”, “patient satisfaction”, “psychometric” or one of 395 known PRO instruments. The obvious omission is “diary” as used in other searches but other terms might also be possible. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 23, 2009 Category: Radiology Authors: Damian McEntegart Tags: Letters to the Editor Source Type: journals

Recruitment strategies for a lung cancer chemoprevention trial involving ex-smokersEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In this report, we describe the recruitment process and evaluated the effectiveness of various recruitment strategies utilized in our National Cancer Institute sponsored lung cancer chemoprevention study with celecoxib. Heavy ex-smokers were recruited into the study through various methods such as radio advertisements, print media, mass mailings, flyers, internet postings and others. The number of inquiries, on-site screenees and randomization generated by each method determined the efficacy of that recruitment strategy. We prescreened 4470 individuals, invited 323 people for on-site screening and randomized 137 subjects. ...
Source: Contemporary Clinical Trials - June 21, 2009 Category: Radiology Authors: Steve H. Kye, Donald P. Tashkin, Michael D. Roth, Bradley Adams, Wen-Xian Nie, Jenny T. Mao Tags: Patient recruitment Source Type: journals

Novel strategies implemented to ensure high participant retention rates in a community based HIV prevention effectiveness trial in South Africa and ZimbabweEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: The high retention rates were achievable in this trial through added staff efforts and resources. Community involvement was also crucial to achieve these rates. Retention of trial participants should be considered during trial design and implemented from the onset. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 14, 2009 Category: Radiology Authors: Sharika Gappoo, Elizabeth T. Montgomery, Caitlin Gerdts, Sarita Naidoo, Agnes Chidanyika, Busi Nkala, Gita Ramjee, The MIRA Team Tags: Clinical trial management and optimization Source Type: journals

Local recruitment experience in a study comparing the effectiveness of a low glycaemic index diet with a low calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with polycystic ovary syndrome (PCOS)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: Planned future trials on over-weight women with PCOS should be multicentre and should incorporate primary care. This data will help other researchers plan and calculate the sample size and potential recruitment rates in future clinical trials in PCOS. The results will also be useful for inclusion in future meta-analyses. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 9, 2009 Category: Radiology Authors: William Atiomo, Anna Read, Mary Golding, Paul Silcocks, Nuguelis Razali, Sabitabrata Sarkar, Paul Hardiman, Jim Thornton Tags: Patient recruitment Source Type: journals

Intracluster correlation adjustments to maintain power in cluster trials for binary outcomesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Adequately powered sample size calculations for cluster randomized trials primarily depend on the event rate variability, effect size, average cluster size, and intracluster correlation (ICC). Furthermore, an ICC estimate depends on event rate variability among clusters, cluster size, and number of clusters. We evaluated the impact on ICC estimates of event rates, event rate variations, cluster size, and cluster size variations for different numbers of clusters. We also evaluated how the event rate changes at the end of the trial affect ICC estimates. We created one simulation exercise to investigate how differen...
Source: Contemporary Clinical Trials - May 24, 2009 Category: Radiology Authors: Hrishikesh Chakraborty, Janet Moore, Tyler D. Hartwell Tags: Study design, statistical design, study protocols Source Type: journals

Editorial BoardEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 15, 2009 Category: Radiology Source Type: journals

An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Enrollment of an adequate number of subjects for a clinical trial is a perennial challenge and this might arguably be even more difficult and complex in trials involving patients with schizophrenia. In this paper, we used a modification of the Prospective Preference Approach (PPA) as a prelude to an actual randomized placebo-controlled trial of a cognitive-enhancing agent for patients with schizophrenia. This approach sought to test and enhance subjects' understanding of the key concepts of the trial, and administered the PPA at baseline and following a brief educational module. The motivations and concerns regar...
Source: Contemporary Clinical Trials - May 11, 2009 Category: Radiology Authors: Siow-Ann Chong, Yuen Yeng Ong, Mythily Subramaniam, Edimansyah Abdin, Christine E. Marx, Alastair Vincent Campbell Tags: Patient recruitment Source Type: journals

Evaluation of the ability of clinical research participants to comprehend informed consent formEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: In conclusion, CS of patients in trials conducted in developing countries can be reasonably good if the investigators explain the consent form in simple language to the participants and CS is not related to the educational status of the participants. Moreover, though a larger majority of patients agree to participate after knowing study details, some patients exercise their right to refuse. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 11, 2009 Category: Radiology Authors: S. Bhansali, N. Shafiq, S. Malhotra, P. Pandhi, Inderjeet Singh, S.P. Venkateshan, S. Siddhu, Y.P. Sharma, K.K. Talwar Tags: Patient recruitment Source Type: journals

Role of vasopressin and aldosterone in pulmonary arterial hypertension: A pilot studyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Much has been learned about the pathophysiological state that underlies the development of increased total body volume and edema in left ventricular failure. Very little, however, is known about the mechanism underlying systemic hypervolemia in patients with isolated right ventricular dysfunction. In this manuscript, we describe our randomized clinical trial to assess the relationship between severity of pulmonary arterial hypertension and neurohormonal activation, total plasma volume and renal function. We assess the role of aldosterone and vasopressin in volume retention in patients with pulmonary arterial hype...
Source: Contemporary Clinical Trials - May 11, 2009 Category: Radiology Authors: Shweta Bansal, David Badesch, Todd Bull, Robert W. Schrier Tags: Clinical trial results Source Type: journals

Recruitment of breast cancer survivors into a 12-month supervised exercise intervention is feasibleEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Discussion: The high recruitment rate demonstrates breast cancer patient's willingness to participate even in long-lasting supervised exercise programs shortly after adjuvant treatments. After taking into account the selection of the population by age and musculoskeletal health, the results of the present intervention can be generalized to represent urban breast cancer patient population in Finland. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 5, 2009 Category: Radiology Authors: Heidi Penttinen, Riku Nikander, Carl Blomqvist, Riitta Luoto, Tiina Saarto Tags: Patient recruitment Source Type: journals

Clinical trial literacy among injecting drug users in Sydney, Australia: A pilot studyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: This pilot study examined knowledge, understanding and perceived acceptability of key methodological concepts in clinical trials among injecting drug users (IDUs) in Sydney, Australia. Participants were clinical trial-experienced (n=17) and trial-naïve (n=99) IDUs recruited from community needle and syringe programs, and through institutions involved in clinical trials with IDU participants. Cross-sectional data were collected via a study-specific interviewer-administered survey. Following detailed verbal explanations, higher proportions of trial-experienced than trial-naïve participants demonstrated an underst...
Source: Contemporary Clinical Trials - May 5, 2009 Category: Radiology Authors: Anna Doab, Libby Topp, Carolyn A. Day, Gregory J. Dore, Lisa Maher Tags: Patient recruitment Source Type: journals

Designing clinical trials and experiments efficiently with the program package CADEMOEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: This paper suggests the use of the program package CADEMO when designing clinical trials. Using this package a number of frequently incorrect or inefficient applications of statistical methods can be avoided. For instance, by determining the sample size for statistical tests in advance, the type-II-risk is guaranteed to be taken into account and, foremost, only relevant effects are likely to become significant. Although this is also true for some other program packages, CADEMO in addition exclusively analyzes data by sequential testing, specifically by sequential triangular tests according to Schneider [Schneider...
Source: Contemporary Clinical Trials - May 4, 2009 Category: Radiology Authors: Dieter Rasch, Klaus D. Kubinger Tags: Study design, statistical design, study protocols Source Type: journals

Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation studyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: An alternative to clinical trial paper-based data collection (PDC) is internet based electronic data collection (EDC), where the investigators over the internet enter data directly in the electronic database by themselves. In our study we considered clinical trial as a business process. Our objective was to model PDC and EDC process and to estimate the difference of the costs of PDC and EDC process for a sample clinical trial based on these models.We used Extended Event-driven Process Chains (eEPC) modeling technique to model PDC and EDC process. In order to evaluate the costs of the processes we assigned costs f...
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Ivan Pavlović, Tomaž Kern, Damijan Miklavčič Tags: Clinical trial management and optimization Source Type: journals

Treatment–subgroup interaction: An example from a published, phase II clinical trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Phase II trial designs that ignore between-patient heterogeneity and do not allow for treatment–subgroup interactions may produce very large false positive and false negative error rates if efficacy varies by subgroup. Recent discussions of this problem were illustrated with scenarios and computer simulations. In this short communication, we reanalyzed a published phase II trial to highlight the need to consider between-patient heterogeneity and the possibility of treatment–subgroup interaction when designing and analyzing phase II studies. The single-arm trial evaluated amsacrine plus cytosine arabinoside, v...
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Carolyn E. Behrendt, Edmund A. Gehan Tags: Study design, statistical design, study protocols Source Type: journals

Brief strategic family therapy™ for adolescent drug abusers: A multi-site effectiveness studyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Brief strategic family therapy™ (BSFT) is a manualized treatment designed to address aspects of family functioning associated with adolescent drug use and behavior problems (J. Szapocznik, U. Hervis, S. Schwartz, (2003). Brief strategic family therapy for adolescent drug abuse. (NIH Publication No. 03-4751). Bethesda, MD: National Institute on Drug Abuse). Within the National Institute on Drug Abuse's (NIDA's) Clinical Trials Network, BSFT is being compared to treatment as usual (TAU) in a multisite, prospective randomized clinical trial for drug using adolescents and their families in outpatient settings. The ...
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Michael S. Robbins, José Szapocznik, Viviana E. Horigian, Daniel J. Feaster, Marc Puccinelli, Petra Jacobs, Kathy Burlew, Robert Werstlein, Ken Bachrach, Greg Brigham Tags: Study design, statistical design, study protocols Source Type: journals

Early anti-pseudomonal acquisition in young patients with cystic fibrosis: Rationale and design of the EPIC clinical trial and observational study,Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: These companion studies will provide valuable epidemiological and microbiological information on early CF lung disease and Pa acquisition, and safety and clinical efficacy data on anti-pseudomonal treatment strategies for early Pa infections in the airways of young children with CF. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Miriam M. Treggiari, Margaret Rosenfeld, Nicole Mayer-Hamblett, George Retsch-Bogart, Ronald L. Gibson, Judy Williams, Julia Emerson, Richard A. Kronmal, Bonnie W. Ramsey, EPIC Study Group Tags: Study design, statistical design, study protocols Source Type: journals

The burden of asthma in the Chicago community fifteen years after the availability of national asthma guidelines: The design and initial results from the CHIRAH studyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Since the early 1990s, asthma burden has been recognized as a national public health concern in the United States . The asthma burden has disproportionately affected persons of certain racial/ethnic backgrounds, principally African Americans and those persons living in urban environments . Concern about the growing problem of asthma has led to a number of national, state, and local efforts towards improving asthma outcomes and control . (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Kevin B. Weiss, John Jay Shannon, Laura S. Sadowski, Lisa K. Sharp, Laura Curtis, Christopher S. Lyttle, Rajesh Kumar, Madeleine U. Shalowitz, Lori Weiselberg, Catherine D. Catrambone, Arthur Evans, Romina Kee, Jon Miller, Linda Kimmel, Leslie C. Grammer Tags: Study design, statistical design, study protocols Source Type: journals

Physical activity and lymphedema (the PAL trial): Assessing the safety of progressive strength training in breast cancer survivorsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Lymphedema is a chronic and progressive long-term adverse effect of breast cancer treatment commonly defined by swelling of the affected arm. Current clinical guidelines indicate that women with and at risk for lymphedema should protect the affected arm from overuse. In clinical practice, this often translates into risk aversive guidance to avoid using the arm. This could lead to a disuse pattern that may increase the likelihood of injury from common activities of daily living. Further, such guidance poses an additional barrier to staying physically active, potentially translating to weight gain, which has been s...
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Kathryn H. Schmitz, Andrea B. Troxel, Andrea Cheville, Lorita L. Grant, Cathy J. Bryan, Cynthia R. Gross, Leslie A. Lytle, Rehana L. Ahmed Tags: Study design, statistical design, study protocols Source Type: journals

Personal physicians as study investigators: Impact on patients' willingness to participate in clinical trialsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Background: We asked whether patients are more willing to participate (WTP) in a cardiovascular drug trial if their personal rather than an unfamiliar physician were engaged as the study investigator.Methods: We approached 1440 randomly selected patients from 13 Maryland-based outpatient cardiology and general medicine clinics to complete an 86-item self-administered questionnaire. We then asked respondents their WTP if their personal rather than an unfamiliar physician were the study investigator, as well as their trust in physicians and quality of their health care experiences.Results: Of 1132 patients eligible...
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Noëlle S. Sherber, Neil R. Powe, Joel B. Braunstein Tags: Patient recruitment Source Type: journals

Managing clinical grant costsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: The rapidly increasing cost of pharmaceutical R&D presents a major challenge for the industry. This paper examines one aspect of that spending, clinical grants, and presents ways that pharmaceutical companies can best manage those expenditures. The first part of the paper examines the role of clinical grant payments as a motivation for clinical trial participation. The second part outlines a number of current management practices for controlling clinical grant costs.Financial compensation is an important matter for many physicians conducting clinical trials, especially those in office-based practices and those co...
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Harold E. Glass, Karen Hollander Tags: Clinical trial management and optimization Source Type: journals

Predictors of study completion and withdrawal in a randomized clinical trial of a pediatric diabetes adherence interventionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: Pre-randomization screening of participants on both demographic and psychological variables may help identify those at greatest risk for study withdrawal or poor study protocol adherence, permitting the investigators to develop retention strategies aimed at this high-risk group. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Kimberly A. Driscoll, Michael Killian, Suzanne Bennett Johnson, Janet H. Silverstein, Larry C. Deeb Tags: Clinical trial management and optimization Source Type: journals

A double-blind, placebo-controlled treatment trial of citalopram for major depressive disorder in older patients with heart failure: The relevance of the placebo effect and psychological symptomsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study was developed to investigate the effectiveness of antidepressant treatment for major depressive disorder (MDD) in the elderly with heart failure.Methods: We enrolled 72 older outpatients with ejection fraction (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Renerio Fraguas, Renata Martinho da Silva Telles, Tânia Correa Toledo Ferraz Alves, Anna Maria Andrei, Jairo Rays, Dan V. Iosifescu, Mauricio Wajngarten Tags: Special interest paper Source Type: journals

A novel diagram and complement to the CONSORT chart for presenting multimodal clinical trialsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: We developed a novel diagram to depict patient flow and outcomes in clinical trials. In contrast to flow diagrams such as the CONSORT chart, our diagram enables individual patient histories to be traced and depicts important patterns of treatment administration and outcomes, such as response and adverse events. Also, it is particularly useful for multimodal treatments or a sequence of different therapies where the CONSORT flow chart is less informative and can be confusing. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Jan C. Schuller, Michael Mayer, Doris Lanz, Shu-Fang Hsu Schmitz, Peter Brauchli, Nicolas Leupin Tags: Clinical trial results Source Type: journals

Denoising of arterial and venous Doppler signals using discrete wavelet transform: Effect on clinical parametersEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: In this paper, the effects of a wavelet transform based denoising strategy on clinical Doppler parameters are analyzed. The study scheme included: (a) Acquisition of arterial and venous Doppler signals by sampling the audio output of an ultrasound scanner from 20 healthy volunteers, (b) Noise reduction via decomposition of the signals through discrete wavelet transform, (c) Spectral analysis of noisy and noise-free signals with short time Fourier transform, (d) Curve fitting to spectrograms, (e) Calculation of clinical Doppler parameters, (f) Statistical comparison of parameters obtained from noisy and noise-free...
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Mahmut Tokmakçı, Nuri Erdoğan Tags: Clinical trial results Source Type: journals

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As we continue to expand the Associate Editorial Board for Contemporary Clinical Trials and refine the peer review process, we have not forgotten the importance of looking outward to our devoted constituency. Our goal as Editors of the journal has always been to provide a platform for presentation and discussion of all the important scientific subjects comprised in this complex and multi-faceted field. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Authors: Kathleen Drennan, Beth Kazol Tags: Editorial Source Type: journals

Editorial BoardEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 1, 2009 Category: Radiology Source Type: journals

Marketing therapeutic precision: Potential facilitators and barriers to adoption of n-of-1 trialsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: Researchers interested in expanding the appeal of n-of-1 trials will need to address these concerns by carefully explaining the approach, emphasizing the benefits, and minimizing the effort required of doctors and patients. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 28, 2009 Category: Radiology Authors: Richard L. Kravitz, Debora A. Paterniti, M. Cameron Hay, Saskia Subramanian, Dionne Evans Dean, Thomas Weisner, Sunita Vohra, Naihua Duan Tags: Patient recruitment Source Type: journals

A non-inferiority test of areas under two parametric ROC curvesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Equivalence or non-inferiority in diagnostic accuracy of two medical diagnostic tests is a common medical problem. Statistical tests of non-inferiority of diagnostic tests have long been a subject of interest in medicine and biostatistical research. Accuracy of a continuous diagnostic test can be evaluated by the area under a receiver operating characteristic (ROC) curve. A conventional non-inferiority test for areas of two parametric ROC curves has been proposed by Zhou, Obuchowski, and McClish [Zhou XH, Obuchowski NA, McClish DK. Statistical Methods in Diagnostic Medicine. New York: John Wiley; 2002]. In this p...
Source: Contemporary Clinical Trials - April 26, 2009 Category: Radiology Authors: Hua Jin, Ying Lu Tags: Study design, statistical design, study protocols Source Type: journals

Implementing a palm pilot intervention for primary care providers: Lessons learnedEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: The Personal Digital Assistance for Guideline Adherence (GLAD Heart) study was designed to test a strategy to improve quality of care through increased adherence to ATPIII cholesterol guidelines. This paper describes the overall study design including the multi-faceted intervention and outcome measures. Sixty-one primary care practices in NC were recruited and randomized to either a personal digital assistant-based cholesterol management intervention or an intervention similar in intensity and frequency of contact but focused on a hypertension clinical practice guideline. Installation and implementation of the te...
Source: Contemporary Clinical Trials - April 21, 2009 Category: Radiology Authors: Erica L. Rosenberger, David C. Goff, Caroline S. Blackwell, Dustin T. Williams, O. Lenore Crago, Shellie D. Ellis, Alain G. Bertoni, Denise E. Bonds Tags: Clinical trial management and optimization Source Type: journals

Effect of imbalance and intracluster correlation coefficient in cluster randomization trials with binary outcomes when the available number of clusters is fixed in advanceEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: In some cluster randomization trials, the number of clusters cannot exceed a specified maximum value due to cost constraints or other practical reasons. Donner and Klar [Donner A, and Klar N. Design and analysis of cluster randomization trials in health research. Oxford University Press 2000] provided the sample size formula for the number of subjects required per cluster when the number of clusters cannot exceed a specified maximum value. The sample size formula of Donner and Klar assumes that the number of subjects is the same in each cluster. In practical situations, the number of subjects may be different amo...
Source: Contemporary Clinical Trials - April 20, 2009 Category: Radiology Authors: Chul Ahn, Fan Hu, Celette Sugg Skinner, Daniel Ahn Tags: Clinical trial management and optimization Source Type: journals

Rationale, design and baseline characteristics of the PRO-TECT II study: PROpofol CardioproTECTion for Type II diabetics: A randomized, controlled trial of high-dose propofol versus isoflurane preconditioning in patients undergoing on-pump coronary artery bypass graft surgeryEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Diabetes mellitus is a leading cause of death globally and results in significant morbidity and mortality following surgery. After cardiac surgery, diabetic patients are especially at risk for low cardiac output syndrome, which can quadruple the risk for postoperative death. Attempts to prevent low cardiac output syndrome have focused on increasing myocardial tolerance to ischemia (preconditioning), which involves the myocardial mitochondrial ATP-regulated KATP channel, G-protein initiation, nitric oxide synthase, and protein kinase C. Unfortunately, the signal transduction pathways required for preconditioning a...
Source: Contemporary Clinical Trials - April 15, 2009 Category: Radiology Authors: David M. Ansley, Koen Raedschelders, David D.Y. Chen, Peter T. Choi Tags: Study design, statistical design, study protocols Source Type: journals

Diabetes nurse case management and motivational interviewing for change (DYNAMIC): Study design and baseline characteristics in the Chronic Care Model for type 2 diabetesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Abstract: Background: Despite evidence that diabetes is costly and devastating, the health care system is poorly equipped to meet the challenges of chronic disease care. The Penn State Institute of Diabetes & Obesity is evaluating a model of managing type 2 DM which includes nurse case management (NCM) and motivational interviewing (MI) to foster behavior change. The primary care intervention is designed to improve patients' self care and to reduce clinical inertia through provider use of standardized clinical guidelines to achieve better diabetes outcomes.Methods: This RCT tests the efficacy of an enhanced NCM interventio...
Source: Contemporary Clinical Trials - April 12, 2009 Category: Radiology Authors: Heather L. Stuckey, Cheryl Dellasega, Nora J. Graber, David T. Mauger, Irina Lendel, Robert A. Gabbay Tags: Study design, statistical design, study protocols Source Type: journals

An analysis of current pharmaceutical industry practices for making clinical trial results publicly accessibleEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In conclusion, our study indicates that the public faces significant hurdles in finding and understanding clinical trial results databases. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 12, 2009 Category: Radiology Authors: Christopher Viereck, Pol Boudes Tags: Special interest papers Source Type: journals