MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'Contemporary Clinical Trials' source. Sat, 20 Mar 2010 15:17:02 +0100 http://www.medworm.com/index.php?rid=3320577&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714410000121%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320577 Mon, 01 Mar 2010 00:00:00 +0100 3320577 http://www.medworm.com/index.php?rid=3320578&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714410000078%2Fabstract%3Frss%3Dyes In Contemporary Clinical Trials, Hsu et al. reported meta-analysis based on 14 randomized trials that used systemic therapy as an experimental arm and placebo/supportive care as control for unresectable hepatocellular carcinoma (HCC). Among the latter, predictors of survival include trial sites (Asian vs. non-Asian; the most significant predictor), severity of cirrhosis and hepatitis B virus infection (in contrast to hepatitis C). (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320578 Wed, 17 Feb 2010 00:00:00 +0100 3320578 http://www.medworm.com/index.php?rid=3320588&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714410000066%2Fabstract%3Frss%3Dyes Abstract: The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age ≥18 who met Diagnostic and Statistical Manual, 4th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (b... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320588 Mon, 15 Feb 2010 00:00:00 +0100 3320588 http://www.medworm.com/index.php?rid=3320587&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714410000054%2Fabstract%3Frss%3Dyes Abstract: Treatment research with opioid-dependent populations has not traditionally distinguished between those dependent on prescription opioids versus dependent upon heroin. Evidence suggests there is a substantial subpopulation of individuals with opioid dependence resulting largely or exclusively from prescription opioid use. Because this subpopulation may respond to treatment differently from heroin users, a method for discriminating DSM-IV opioid dependence due to prescription opioid use would provide more precision when examining this population. This paper describes an innovative method using a currently available diagnostic instrument, to diagnose DSM-IV opioid dependence and distinguish between dependence resulting from prescription opioids versus dependence upon heroin. (Source... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320587 Wed, 03 Feb 2010 00:00:00 +0100 3320587 http://www.medworm.com/index.php?rid=3320585&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714410000030%2Fabstract%3Frss%3Dyes Abstract: Background:: The relationship between darbepoetin alfa and fatigue in chemotherapy-induced anemia (CIA) patients is complex because of patients receiving transfusions and the mediating effect of hemoglobin. Latent growth models (LGMs) were used to examine simultaneously relationships among drug exposure, fatigue outcomes, covariates, and mediating factors.Methods:: Data from four CIA studies (AMG 20010145: small cell lung cancer, n=547; AMG 980297: lung cancer, n=288; AMG 20000161: lymphoproliferative malignancies, n=339; AMG 20030232: non-myeloid malignancies, n=320) were analyzed separately. Patients reported fatigue using the FACT-Fatigue. The effect of darbepoetin alfa on FACT-F changes mediated through hemoglobin changes was examined with LGMs controlling for transfusions, a... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320585 Mon, 25 Jan 2010 00:00:00 +0100 3320585 http://www.medworm.com/index.php?rid=3320579&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714410000042%2Fabstract%3Frss%3Dyes Sudden, involuntary, repetitive muscle movements (motor tics) and vocalizations (vocal tics) characterize Tourette's syndrome (TS), which has been described first by the neurologist Gilles de la Tourette in 1885. The nature and complexity of the tics are usually variable over time with natural waxing and waning in frequency and severity. There are alsoassociated behavioral problems, such as obsessions and compulsions, inattention, hyperactivity, and impulsivity. Symptom onset typically occurs during childhood or early adolescence. The etiopathogenesis of Gilles de la Tourette's syndrome has not been ascertained, but the frontal-subcortical neural pathways seem to be involved. The syndrome is frequently associated with attention-deficit/hyperactivity disorder, obsessive-compulsive disorder,... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320579 Mon, 25 Jan 2010 00:00:00 +0100 3320579 http://www.medworm.com/index.php?rid=3320586&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714410000029%2Fabstract%3Frss%3Dyes Abstract: Since its introduction in 1974 the use of the term Minimization has been broadened to include other algorithms. All algorithms use patient characteristics to determine the assignment that produces the best overall balance between treatment groups. They differ in whether or not they use all of the data from each previously assigned subject to assign subsequent subjects so the methods are classified as complete or partial minimization. PubMed, Citation Index and Cochrane searches determined the frequency of articles using these types of minimization and a subset was selected for detailed review regarding the adequacy of the usage and reporting of minimization. In the past 10years usage has increased three fold over the previous decade but is still less than 2% of clinical trials. N... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320586 Mon, 18 Jan 2010 00:00:00 +0100 3320586 http://www.medworm.com/index.php?rid=3320582&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409002146%2Fabstract%3Frss%3Dyes Conclusion: Our results demonstrate the importance of the community–academic partnership formed and adherence to the principles of CBPR in carrying out this work. Despite challenges in recruitment of racially and ethnically diverse participants for research, we successfully recruited, enrolled, and retained young black men in an HIV prevention program. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320582 Fri, 08 Jan 2010 00:00:00 +0100 3320582 http://www.medworm.com/index.php?rid=3320581&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409002080%2Fabstract%3Frss%3Dyes In this study RM is compared to M for balance of variables and vulnerability to selection bias in 1000 simulated trials using 200 subjects with 15 continuous variables. With RM there were no instances of significant imbalance to cause rejection of the null hypothesis, i.e. a Student's t≥2, although it occurred in 0.4% of the 15000 tests for M. For moderate imbalance, i.e. 1≤t (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320581 Fri, 08 Jan 2010 00:00:00 +0100 3320581 http://www.medworm.com/index.php?rid=3320584&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409002109%2Fabstract%3Frss%3Dyes Abstract: Introduction: In promoting the health of chronically ill children, the hospital should help children cope both medically and psychosocially with their disease. The University Children's Hospital of Nancy proposes adapted physical activity for hospitalized children, but the practice during hospitalization is not well developed or understood. The ACTIV'HOP study aims to assess the effects of adapted physical activity sessions for hospitalized children in terms of 1) health-related quality of life (HRQoL) and 2) satisfaction with hospital care.Research design: ACTIV'HOP is an individual randomized controlled trial of patients admitted to the University Children's Hospital of Nancy. The inclusion criteria are 1) age 5 to 18years, 2) hospitalized for at least 3days, and 3) no medical ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320584 Tue, 05 Jan 2010 00:00:00 +0100 3320584 http://www.medworm.com/index.php?rid=3320583&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409002092%2Fabstract%3Frss%3Dyes Conclusion: This study will provide unique and comprehensive nutritional data and its results will guide nutritional therapy for children undergoing HSCT and possibly other catabolic patients. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320583 Tue, 05 Jan 2010 00:00:00 +0100 3320583 http://www.medworm.com/index.php?rid=3144641&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409002122%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144641 Fri, 01 Jan 2010 00:00:00 +0100 3144641 http://www.medworm.com/index.php?rid=3144640&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001876%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144640 Fri, 01 Jan 2010 00:00:00 +0100 3144640 http://www.medworm.com/index.php?rid=3320580&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001815%2Fabstract%3Frss%3Dyes In this study the enhancement in speed and efficiency of recruitment and quality of data collection as a result of this system outweighed the initial investment. Web-based systems have the potential to streamline the process of recruitment and day-to-day management of clinical trials in addition to improving efficiency and quality. Because of their added value they should be considered for trials of moderate size or complexity. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3320580 Mon, 07 Dec 2009 00:00:00 +0100 3320580 http://www.medworm.com/index.php?rid=3144659&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001827%2Fabstract%3Frss%3Dyes Abstract: In traditional randomized controlled trial (RCT) designs, patients who are ineligible for randomization are excluded from study participation. However, these patients often constitute an important subgroup of the disease population. By extending existing RCT infrastructure, efforts to evaluate such patients in parallel cohort arms would provide an efficient means of generating multi-center prospective data on natural history, which would facilitate the development of future RCTs involving these subgroups of interest. This brief report discusses principles of the parallel-cohort RCT design, describes the few published trials in which it has been employed, and highlights novel aspects of its use in the Kids-DOTT trial—an ongoing multi-center randomized trial of the duration of an... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144659 Fri, 04 Dec 2009 00:00:00 +0100 3144659 http://www.medworm.com/index.php?rid=3144657&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001803%2Fabstract%3Frss%3Dyes Abstract: To identify key challenges and propose technical considerations in designing electronic case report form (eCRF) for post-marketing studies, the author undertakes a comprehensive literature review of peer reviewed and grey literature to assess the key aspects, processes, standards, recommendations, and best practices in designing eCRFs based on industry experience in designing and supporting electronic data capture (EDC) studies. Literature search using strings on MEDLINE and PUBMED returned few papers directly related to CRF design. Health informatics and general practice journals were searched and results reviewed. Many conference, government commission, health professional and special interests group websites provide relevant information from practical experience — summarizat... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144657 Mon, 30 Nov 2009 00:00:00 +0100 3144657 http://www.medworm.com/index.php?rid=3144645&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001773%2Fabstract%3Frss%3Dyes Abstract: A careful consideration of the alternatives to research participation is an essential element of making an informed choice to enroll in a biomedical research study. While there is general agreement on the importance of informing prospective subjects about alternatives to research participation, little is known about how investigators communicate this information. The purpose of this study was to attempt to assess the quality of information about alternatives contained in informed consent documents in oncology randomized controlled trials. Our study indicates that there is room for improvement concerning the discussion of alternatives to research participation in informed consent documents in oncology randomized controlled trials. Though most of the documents in our study met the ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144645 Fri, 20 Nov 2009 00:00:00 +0100 3144645 http://www.medworm.com/index.php?rid=3144648&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001785%2Fabstract%3Frss%3Dyes Conclusions: Conducting successful clinical trials internationally requires early and ongoing collaboration to ensure the study meets sites' requirements and expectations, conforms to varying national regulations, adheres to data quality standards and is responsive to the health needs of studied populations. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144648 Thu, 19 Nov 2009 00:00:00 +0100 3144648 http://www.medworm.com/index.php?rid=3144658&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001797%2Fabstract%3Frss%3Dyes Conclusions: Men 50years or older can successfully be recruited to a video-based intervention trial with the aim to reduce their burden through skin cancer. Randomization by computer generated randomization list resulted in good balance between control and intervention group and baseline analysis determined factors associated with skin cancer early detection behavior. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144658 Wed, 18 Nov 2009 00:00:00 +0100 3144658 http://www.medworm.com/index.php?rid=3144656&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS155171440900175X%2Fabstract%3Frss%3Dyes Abstract: The continual reassessment method (CRM) and subsequent developments of the Bayesian approach provide important tools for the design of Phase I cancer clinical trials for a new molecular entity. In recent years the idea of developing a treatment composed of two molecular entities has been proposed. For example, for some tumor types there may be two signaling pathways, both of which need to be blocked simultaneously using two molecules to achieve therapeutic benefit. A two-stage Bayesian and likelihood based algorithm is introduced herein for designing Phase I cancer clinical trials for two new molecular entities. It starts with a modified CRM approach in the first stage and makes use of the accumulated data from the first stage to provide likelihood estimates of model parameters f... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144656 Wed, 18 Nov 2009 00:00:00 +0100 3144656 http://www.medworm.com/index.php?rid=3144650&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001736%2Fabstract%3Frss%3Dyes Abstract: Recruitment strategies employed by four clinical centers across the US and a coordinating center were examined to identify successful overall and minority-focused recruitment strategies for the PREMIER multicenter trial of lifestyle changes for blood pressure control. The goal was to recruit 800 adults (40% African Americans) with systolic blood pressure of 120–159mmHg and diastolic of 80–95mmHg, not taking antihypertensive medication. Clinical centers used combinations of mass distribution of brochures, mass media, email distribution lists, screening events, and a national website. Culturally appropriate strategies for African Americans were designed by a Minority Implementation (MI) committee. Diversity training was provided for study staff, and African Americans were inclu... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144650 Wed, 18 Nov 2009 00:00:00 +0100 3144650 http://www.medworm.com/index.php?rid=3144642&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001761%2Fabstract%3Frss%3Dyes I am intrigued to have read the paper by Pavlovic et al. (July 2009) with the engineering of paper-based data collection (PDC) and EDC cost estimating using business modeling methodology. The authors' ingenuity in applying information technology (IT) to optimize clinical trial management should be applauded. They designed simulation to estimate cost in PDC and EDC subprocesses and took consideration of parameters such as clinical trial size, query rates, average efforts, and staff prices. They concluded that EDC technologies provide saving benefits in the range of 49–62% given different parameter variations through reducing monitoring and data management cost. Though their approximation and discussion seem to be reasonable, I would like to bring up some observations. (Source: Contemporar... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144642 Wed, 18 Nov 2009 00:00:00 +0100 3144642 http://www.medworm.com/index.php?rid=3144644&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001748%2Fabstract%3Frss%3Dyes Abstract: Noncompliance is a common problem in drawing causal inference in randomized trials. The instrumental variable (IV) method estimates the average causal effect in randomized trials with noncompliance. However, the IV estimator generally yields a biased estimate under a non-null hypothesis, although it can yield an unbiased estimate under a null hypothesis. Therefore, it is important to evaluate the potential bias of the IV estimate quantitatively. This paper provides such a quantitative method, which is an extension of bias analysis for unmeasured confounders using the confounding risk difference in the context of observational studies. The proposed method will help investigators to provide a realistic picture of the potential bias of the IV estimate. It is illustrated using a fiel... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144644 Mon, 16 Nov 2009 00:00:00 +0100 3144644 http://www.medworm.com/index.php?rid=3144660&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001724%2Fabstract%3Frss%3Dyes The authors regret that in the above published paper there was an error in . The mean baseline BPRS-Total score was 53.7 (sd=7) at the original sites and 54.6 (sd=8) at the added sites. The corrected table can be found overleaf. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144660 Mon, 09 Nov 2009 00:00:00 +0100 3144660 http://www.medworm.com/index.php?rid=2926325&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001670%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2926325 Mon, 26 Oct 2009 15:43:19 +0100 2926325 http://www.medworm.com/index.php?rid=3144655&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001554%2Fabstract%3Frss%3Dyes Conclusion: The HHER Lifestyle trial is unique in that it targets financially disadvantaged African American women from community health centers, incorporates a standard care intervention into a routine clinical appointment, and includes a comprehensive process evaluation. The design will permit further research examining the added effect of regular telephone counseling and tailored print materials to a primary care provider and nurse intervention. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144655 Mon, 19 Oct 2009 00:00:00 +0100 3144655 http://www.medworm.com/index.php?rid=3144654&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001530%2Fabstract%3Frss%3Dyes This study aims to demonstrate that these challenges can be overcome through the use of telephone-based tobacco quit lines (QLs). This report describes the design of the St. Jude Cancer Survivor Tobacco QL study, which is a randomized controlled clinical trial that will examine the long-term (1-year) efficacy of a counselor initiated vs. participant initiated tobacco QL with adjunctive nicotine replacement therapy (NRT) in both groups. Participants (N=950) will be recruited nationally and randomly assigned to one of the two interventions. The counselor initiated intervention includes six scheduled telephone sessions of a behavioral intervention and provision of 8weeks of NRT. The participant initiated intervention allows the participant to call the QL at their convenience, but includes the... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144654 Mon, 12 Oct 2009 00:00:00 +0100 3144654 http://www.medworm.com/index.php?rid=3144649&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001566%2Fabstract%3Frss%3Dyes Conclusion: Women with symptomatic uterine leiomyomas may be attracted to participate in leiomyoma trials, however desire for specific treatment and persistent symptoms following intervention may hinder their participation. Randomization to placebo treatment and stringent inclusion criteria appear to adversely impact accrual. A wide range of recruiting tactics is needed and media sources or direct mailings may prove particularly effective to improve subject recruitment and retention in clinical leiomyoma trials. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144649 Mon, 12 Oct 2009 00:00:00 +0100 3144649 http://www.medworm.com/index.php?rid=3144647&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001542%2Fabstract%3Frss%3Dyes Abstract: A computerized regulatory document management system has been developed as a module in a comprehensive Clinical Trial Management System (CTMS) designed for an NIH-funded clinical trial network in order to more efficiently manage and track regulatory compliance. Within the network, several institutions and investigators are involved in multiple trials, and each trial has regulatory document requirements. Some of these documents are trial specific while others apply across multiple trials. The latter causes a possible redundancy in document collection and management. To address these and other related challenges, a central regulatory document management system was designed. This manuscript shares the design of the system as well as examples of it use in current studies. (Source: Co... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144647 Mon, 12 Oct 2009 00:00:00 +0100 3144647 http://www.medworm.com/index.php?rid=3144653&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001517%2Fabstract%3Frss%3Dyes Abstract: Although the Diabetes Prevention Program (DPP) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals, it has yet to be widely adopted at the community level. The Healthy Living Partnership to Prevent Diabetes study (HELP PD) was designed to translate the DPP approach for use in community settings as a cost-effective intervention led by Community Health Workers (CHW's) and administered through a Diabetes Care Center (DCC). Approximately 300 overweight and obese (BMI 25-40kg/m2) individuals with prediabetes (fasting blood glucose 95-124mg/dl) were randomly assigned to either a lifestyle weight loss intervention (LW) or an enhanced usual care comparison condition (UC). The goal of LW is ≥7% weight loss achieve... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144653 Mon, 05 Oct 2009 00:00:00 +0100 3144653 http://www.medworm.com/index.php?rid=3144652&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001505%2Fabstract%3Frss%3Dyes Abstract: Background: Nonalcoholic fatty liver disease (NAFLD) in children can lead to steatohepatitis, cirrhosis, and end-stage liver disease. The cause of NAFLD is unknown, but it is commonly associated with obesity, insulin resistance, and dyslipidemia.Objectives: TONIC is conducted to test whether treatment with metformin, an insulin sensitizer, or vitamin E, a naturally available antioxidant, will lead to improvements in biochemical and histological features of nondiabetic children with biopsy-proven NAFLD.Design: TONIC is a randomized, multicenter, double-masked, placebo-controlled trial of 96weeks of treatment with metformin or vitamin E. The primary outcome measure chosen for the trial is improvement in serum alanine aminotransferase (ALT) levels with treatment as compared to place... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144652 Mon, 05 Oct 2009 00:00:00 +0100 3144652 http://www.medworm.com/index.php?rid=3144651&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001499%2Fabstract%3Frss%3Dyes This study sought to identify contributory factors for this geographic difference. A systematic review was done on randomized trials for unresectable HCC that used systemic therapy as an experimental arm and placebo or supportive care as control. Meta-analysis was performed with the consideration of fixed and random effects. Then, meta-regression was performed to identify predictors of patient survival in the control arm and the treatment effects (improvement in median survival). Fourteen trials (6 Asians, 8 non-Asians) were eligible for meta-analysis. The median survival of patients in the control arm, which indicated natural history of advanced HCC patients, was 3.57±1.88months in Asian trials and 5.96±1.46months in non-Asian trials (p=0.02). Independent predictors of better survival i... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144651 Mon, 05 Oct 2009 00:00:00 +0100 3144651 http://www.medworm.com/index.php?rid=3144646&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001529%2Fabstract%3Frss%3Dyes Conclusions: Disappointment was common after allocation to the control group. This is a probable explanation of the higher drop-out rate in the control group. The consent information is of highest importance since those who were very disappointed claimed they did not receive understandable information. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144646 Mon, 05 Oct 2009 00:00:00 +0100 3144646 http://www.medworm.com/index.php?rid=3144643&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001487%2Fabstract%3Frss%3Dyes Conclusions: These data suggest that the GI is difficult to use at the individual level. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=3144643 Tue, 22 Sep 2009 00:00:00 +0100 3144643 http://www.medworm.com/index.php?rid=2926331&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001189%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2926331 Fri, 04 Sep 2009 00:00:00 +0100 2926331 http://www.medworm.com/index.php?rid=2926327&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001177%2Fabstract%3Frss%3Dyes 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 adherence (taking ≥90% of tablets in the preceding 3-months) included older age, understanding trial concepts at enrolment, living >2years in the screening site, receiving ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2926327 Tue, 01 Sep 2009 00:00:00 +0100 2926327 http://www.medworm.com/index.php?rid=2926326&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS155171440900113X%2Fabstract%3Frss%3Dyes 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% Hispanics, 51% blacks; p (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2926326 Fri, 21 Aug 2009 00:00:00 +0100 2926326 http://www.medworm.com/index.php?rid=2707585&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001414%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707585 Tue, 18 Aug 2009 11:05:31 +0100 2707585 http://www.medworm.com/index.php?rid=2926330&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001165%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2926330 Tue, 11 Aug 2009 00:00:00 +0100 2926330 http://www.medworm.com/index.php?rid=2707604&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001153%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707604 Wed, 05 Aug 2009 23:00:00 +0100 2707604 http://www.medworm.com/index.php?rid=2926329&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001128%2Fabstract%3Frss%3Dyes 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, in this paper, we study in greater depth this question. We focus, in particular on three designs used currently; the standard ‘3+3’ design, the grouped up-and-down de... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2926329 Fri, 31 Jul 2009 00:00:00 +0100 2926329 http://www.medworm.com/index.php?rid=2707587&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001086%2Fabstract%3Frss%3Dyes 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 problem is that ICDs alone are insufficient to ensure adequacy of informed consent. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707587 Sun, 26 Jul 2009 23:00:00 +0100 2707587 http://www.medworm.com/index.php?rid=2926332&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001141%2Fabstract%3Frss%3Dyes 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 substantive access may require further steps to overcome substantial institutional barriers. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2926332 Wed, 22 Jul 2009 00:00:00 +0100 2926332 http://www.medworm.com/index.php?rid=2926328&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001116%2Fabstract%3Frss%3Dyes 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 noninferiority design to determine if the group treatment delivered via VTC is as good as the traditional in-person modality. In addition, a cost analysis will be performed in orde... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2926328 Tue, 21 Jul 2009 00:00:00 +0100 2926328 http://www.medworm.com/index.php?rid=2707603&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001098%2Fabstract%3Frss%3Dyes 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 wide ranging simulation study, we consider scenarios differing in skewness, skewness heterogeneity, variance heterogeneity, sample size, and sample size ratio. We find that ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707603 Mon, 20 Jul 2009 23:00:00 +0100 2707603 http://www.medworm.com/index.php?rid=2707591&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001104%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707591 Mon, 20 Jul 2009 23:00:00 +0100 2707591 http://www.medworm.com/index.php?rid=2707602&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001025%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707602 Sun, 05 Jul 2009 23:00:00 +0100 2707602 http://www.medworm.com/index.php?rid=2707589&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001074%2Fabstract%3Frss%3Dyes 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 global assessment”, “sleep questionnaire”, “patient questionnaires”, “subjective sleep”, “patient rated”, “patient rating”, “daily pain rating” an... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707589 Thu, 02 Jul 2009 23:00:00 +0100 2707589 http://www.medworm.com/index.php?rid=2707586&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001062%2Fabstract%3Frss%3Dyes 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 recruitment timeline can't be met, the clinical team increases the site's budget, activates new sites, or hires a recruitment consultant/company that may or may not improve the... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707586 Thu, 25 Jun 2009 23:00:00 +0100 2707586 http://www.medworm.com/index.php?rid=2707593&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001049%2Fabstract%3Frss%3Dyes 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 staff labeling of both the research interview and intervention as “value added time,” and the ability of research staff to assist the clinic beyond the scope of the ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707593 Tue, 23 Jun 2009 23:00:00 +0100 2707593 http://www.medworm.com/index.php?rid=2707588&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001037%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707588 Tue, 23 Jun 2009 23:00:00 +0100 2707588 http://www.medworm.com/index.php?rid=2707600&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001050%2Fabstract%3Frss%3Dyes 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. Radio advertisements (ads) generated the most inquiries (71.1%), followed by internet posting (11.8%), print media (6.0%), posted and racked flyers (4.4%), mass mailings ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707600 Sun, 21 Jun 2009 23:00:00 +0100 2707600 http://www.medworm.com/index.php?rid=2707592&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001013%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707592 Sun, 14 Jun 2009 23:00:00 +0100 2707592 http://www.medworm.com/index.php?rid=2707598&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409001001%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707598 Tue, 09 Jun 2009 23:00:00 +0100 2707598 http://www.medworm.com/index.php?rid=2707601&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000524%2Fabstract%3Frss%3Dyes 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 different event rates, event rate variations, cluster size, and cluster size variations impact ICC estimates and 95% confidence intervals. A separate simulation exercise in four ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707601 Sun, 24 May 2009 23:00:00 +0100 2707601 http://www.medworm.com/index.php?rid=2410327&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000949%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2410327 Fri, 15 May 2009 19:44:17 +0100 2410327 http://www.medworm.com/index.php?rid=2707597&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000548%2Fabstract%3Frss%3Dyes 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 regarding potential participation in the proposed trial were also elicited by the PPA. Of one hundred ninety patients with schizophrenia recruited for this PPA study, only 12 ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707597 Mon, 11 May 2009 23:00:00 +0100 2707597 http://www.medworm.com/index.php?rid=2707594&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000457%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707594 Mon, 11 May 2009 23:00:00 +0100 2707594 http://www.medworm.com/index.php?rid=2707590&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000512%2Fabstract%3Frss%3Dyes 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 hypertension with right ventricular failure. As understanding of the pathogenesis of left ventricular failure has been associated with improved therapies, the better understa... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707590 Mon, 11 May 2009 23:00:00 +0100 2707590 http://www.medworm.com/index.php?rid=2707599&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS155171440900055X%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707599 Tue, 05 May 2009 23:00:00 +0100 2707599 http://www.medworm.com/index.php?rid=2707595&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000500%2Fabstract%3Frss%3Dyes 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 understanding of all clinical trial concepts assessed, including single blinding (94% versus 60%); placebo (94% versus 49%); equipoise (71% versus 60%); comparison (59% versus 4... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707595 Tue, 05 May 2009 23:00:00 +0100 2707595 http://www.medworm.com/index.php?rid=2410329&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000408%2Fabstract%3Frss%3Dyes 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, B. 1992. An interactive computer program for design and monitoring of sequential clinical trials. In Proceedings of the XVIth international biometric conference (pp. 23... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2410329 Mon, 04 May 2009 04:00:00 +0100 2410329 http://www.medworm.com/index.php?rid=2410328&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000445%2Fabstract%3Frss%3Dyes 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 functions to each process function which appears in the model. The parameters which appear in these functions include efforts, staff prices and data quality parameters. We... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2410328 Fri, 01 May 2009 04:00:00 +0100 2410328 http://www.medworm.com/index.php?rid=2385249&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000330%2Fabstract%3Frss%3Dyes 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, vincristine, and prednisone (a combination abbreviated as OAP) for adult acute leukemia, when standard treatment was adriamycin plus OAP. We carried out an analysis of cov... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385249 Fri, 01 May 2009 04:00:00 +0100 2385249 http://www.medworm.com/index.php?rid=2385248&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS155171440900007X%2Fabstract%3Frss%3Dyes 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 effectiveness of BSFT is being compared to TAU in reducing adolescent drug use, conduct problems, and sexually risky behaviors as well as in improving family functioning ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385248 Fri, 01 May 2009 04:00:00 +0100 2385248 http://www.medworm.com/index.php?rid=2385247&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000044%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385247 Fri, 01 May 2009 04:00:00 +0100 2385247 http://www.medworm.com/index.php?rid=2385246&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000056%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385246 Fri, 01 May 2009 04:00:00 +0100 2385246 http://www.medworm.com/index.php?rid=2385245&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000020%2Fabstract%3Frss%3Dyes 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 shown to be associated with worse clinical course for women with lymphedema. We hypothesize that a program of slowly progressive strength training with no upper limit on t... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385245 Fri, 01 May 2009 04:00:00 +0100 2385245 http://www.medworm.com/index.php?rid=2385244&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000032%2Fabstract%3Frss%3Dyes 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, 789 (70%) patients responded and 666 had complete data. Patients were “very likely/likely” to participate in the study 56% of the time if conducted by their persona... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385244 Fri, 01 May 2009 04:00:00 +0100 2385244 http://www.medworm.com/index.php?rid=2385243&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000123%2Fabstract%3Frss%3Dyes 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 conducting phase 4 clinical trials. Since financial considerations are important to most types of investigators, and there is no compelling evidence that paying at high rat... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385243 Fri, 01 May 2009 04:00:00 +0100 2385243 http://www.medworm.com/index.php?rid=2385242&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000093%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385242 Fri, 01 May 2009 04:00:00 +0100 2385242 http://www.medworm.com/index.php?rid=2385241&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000081%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385241 Fri, 01 May 2009 04:00:00 +0100 2385241 http://www.medworm.com/index.php?rid=2385240&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000111%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385240 Fri, 01 May 2009 04:00:00 +0100 2385240 http://www.medworm.com/index.php?rid=2385239&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000068%2Fabstract%3Frss%3Dyes 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 signals. The decomposition level was selected as the highest level at which the maximum power spectral density and its corresponding frequency were preserved. In all sub... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385239 Fri, 01 May 2009 04:00:00 +0100 2385239 http://www.medworm.com/index.php?rid=2385238&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000536%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385238 Fri, 01 May 2009 04:00:00 +0100 2385238 http://www.medworm.com/index.php?rid=2385237&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS155171440900072X%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2385237 Fri, 01 May 2009 04:00:00 +0100 2385237 http://www.medworm.com/index.php?rid=2707596&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000494%2Fabstract%3Frss%3Dyes 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) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2707596 Tue, 28 Apr 2009 23:00:00 +0100 2707596 http://www.medworm.com/index.php?rid=2495456&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000421%2Fabstract%3Frss%3Dyes 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 paper, we showed that this conventional approach is anti-conservative and proposed a new statistical test based on restricted maximum likelihood estimator to achieve desig... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495456 Sun, 26 Apr 2009 23:00:00 +0100 2495456 http://www.medworm.com/index.php?rid=2495451&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000470%2Fabstract%3Frss%3Dyes 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 technology intervention was challenging. Over the course of the study, there were 74 technical issues requiring assistance for the palm pilot from 23 participating practice... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495451 Tue, 21 Apr 2009 23:00:00 +0100 2495451 http://www.medworm.com/index.php?rid=2495450&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000469%2Fabstract%3Frss%3Dyes 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 among clusters. We conducted simulation studies to investigate the effect of the cluster size variability (κ) and the intracluster correlation coefficient (ρ) on the power... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495450 Mon, 20 Apr 2009 23:00:00 +0100 2495450 http://www.medworm.com/index.php?rid=2495457&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000433%2Fabstract%3Frss%3Dyes 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 are corrupted in diabetes.Effective antioxidant intervention during ischemia–reperfusion appears important for preserving myocardial function; thus, alleviating oxidant-... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495457 Wed, 15 Apr 2009 23:00:00 +0100 2495457 http://www.medworm.com/index.php?rid=2495455&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000391%2Fabstract%3Frss%3Dyes 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 intervention on type 2 DM (n=549) patient outcomes mediated by changes in self-care behavior and diabetes management. Outcome measures include: (a) effect on clinical parameters suc... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495455 Sun, 12 Apr 2009 23:00:00 +0100 2495455 http://www.medworm.com/index.php?rid=2495449&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000482%2Fabstract%3Frss%3Dyes In conclusion, our study indicates that the public faces significant hurdles in finding and understanding clinical trial results databases. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495449 Sun, 12 Apr 2009 23:00:00 +0100 2495449 http://www.medworm.com/index.php?rid=2495447&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS155171440900041X%2Fabstract%3Frss%3Dyes Abstract: Major Depression with Psychotic Features (psychotic depression) is a common, debilitating psychiatric disease. We hypothesized that mifepristone, a cortisol receptor (GRII) antagonist, would significantly reduce psychotic symptoms in psychotic depression.Two hundred fifty-eight patients with psychotic depression enrolled at 29 sites were randomized to mifepristone or placebo for 7 days. The primary outcome was rapid and sustained response, defined as a 50% or greater decrease in Brief Psychiatric Rating Scale — Positive Symptom Subscale scores at the end of treatment (day7) and 49 days later (day 56). Cochran–Mantel–Haenszel compared proportions of responders to mifepristone versus placebo adjusting for site. Exploratory analyses compared response of patients with mifepri... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495447 Sun, 12 Apr 2009 23:00:00 +0100 2495447 http://www.medworm.com/index.php?rid=2316937&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19348963%26dopt%3DAbstract Authors: Rosenberger EL, Goff DC, Blackwell CS, Williams DT, Crago OL, Ellis SD, Bonds DE PMID: 19348963 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2316937 Fri, 03 Apr 2009 04:00:00 +0100 2316937 http://www.medworm.com/index.php?rid=2316935&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19348964%26dopt%3DAbstract In conclusion, our study indicates that the public faces significant hurdles in finding and understanding clinical trial results databases. PMID: 19348964 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2316935 Fri, 03 Apr 2009 04:00:00 +0100 2316935 http://www.medworm.com/index.php?rid=2316933&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19348965%26dopt%3DAbstract Authors: Ahn C, Hu F, Skinner CS, Ahn D 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 [1] 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 among clusters. We conducted simulation studies to investigate the effect of the cluster size variability (kappa) and the intracluster correlation coefficient (rho) on the power of the study in which the number of available clusters is fixed in advance. For th... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2316933 Fri, 03 Apr 2009 04:00:00 +0100 2316933 http://www.medworm.com/index.php?rid=2316938&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19345286%26dopt%3DAbstract Authors: Pavlović I, Kern T, Miklavčič D 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 functions to each process function which appears in the model. The parameters which appear in these functions include... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2316938 Wed, 01 Apr 2009 04:00:00 +0100 2316938 http://www.medworm.com/index.php?rid=2495454&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000378%2Fabstract%3Frss%3Dyes Abstract: Acupuncture to treat Bell's palsy is one of the most commonly used methods in China. There are a variety of acupuncture treatment options to treat Bell's palsy in clinical practice. Since Bell's palsy has three different path-stages (acute stage, resting stage and restoration stage), so whether acupuncture is effective in the different path-stages and which acupuncture treatment is the best method are major issues in acupuncture clinical trials about Bell's palsy.In this article, we report the design and protocol of a large sample multi-center randomized controlled trial to treat Bell's palsy with acupuncture. There are five acupuncture groups, with four according to different path-stages and one not. In total, 900 patients with Bell's palsy are enrolled in this study. These pati... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495454 Mon, 30 Mar 2009 23:00:00 +0100 2495454 http://www.medworm.com/index.php?rid=2495452&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS155171440900038X%2Fabstract%3Frss%3Dyes Conclusions: Aggressive outreach and screening is likely not feasible for broader dissemination in everyday practice settings and recruits individuals with more similar demographic and clinical characteristics to those recruited through more abbreviated and realistic screening procedures than anticipated. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495452 Mon, 30 Mar 2009 23:00:00 +0100 2495452 http://www.medworm.com/index.php?rid=2316942&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19341820%26dopt%3DAbstract 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. PMID: 19341820 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2316942 Mon, 30 Mar 2009 04:00:00 +0100 2316942 http://www.medworm.com/index.php?rid=2316940&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19341821%26dopt%3DAbstract Authors: Rasch D, Kubinger KD 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 (1992); which on average lead to a lower sample size. Moreover CADEMO serves to determine the sample size for a confidence estimation of an unknown paramete... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2316940 Mon, 30 Mar 2009 04:00:00 +0100 2316940 http://www.medworm.com/index.php?rid=2316946&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19336261%26dopt%3DAbstract Authors: Jin H, Lu Y 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 paper, we showed that this conventional approach is anti-conservative and proposed a new statistical test based on restricted maximum likelihood estimator t... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2316946 Sun, 29 Mar 2009 04:00:00 +0100 2316946 http://www.medworm.com/index.php?rid=2316944&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19336262%26dopt%3DAbstract Authors: Ansley DM, Raedschelders K, Chen DD, Choi PT 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 K(ATP) channel, G-protein initiation, nitric oxide synthase, and protein kinase C. Unfortunately, the signal transduction pathways required for preconditioning are corrupted in diabetes. Effective antioxidant intervention during ischemia-reperfusion appears important for preservin... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2316944 Sat, 28 Mar 2009 04:00:00 +0100 2316944 http://www.medworm.com/index.php?rid=2316950&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19328244%26dopt%3DAbstract CONCLUSIONS: Baseline includes (mean) age=58; BMI=34.4; 57% females; 47% Caucasian, and 39% Hispanic. Patients had elevated HbA1c (8.4), BP (137/77) and LDL (114). Overall, patients were depressed (CES-D=21.6) and had an extremely negative quality of life (ADDQoL=-1.58). We believe that enhanced NCM will both improve self-care and reduce emotional distress for patients with diabetes. If proven effective, enhanced NCM may be translated to other chronic illnesses. PMID: 19328244 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2316950 Thu, 26 Mar 2009 04:00:00 +0100 2316950 http://www.medworm.com/index.php?rid=2495448&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000366%2Fabstract%3Frss%3Dyes Conclusions: PRO instruments are used in a significant percentage but minority of clinical trials. Trial registries should require that all PRO instruments be identified, including the concepts or outcomes they are intended to measure. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495448 Wed, 25 Mar 2009 00:00:00 +0100 2495448 http://www.medworm.com/index.php?rid=2291804&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19318138%26dopt%3DAbstract Authors: Blasey CM, Debattista C, Roe R, Block T, Belanoff JK Major Depression with Psychotic Features (psychotic depression) is a common, debilitating psychiatric disease. We hypothesized that mifepristone, a cortisol receptor (GRII) antagonist, would significantly reduce psychotic symptoms in psychotic depression. Two hundred fifty-eight patients with psychotic depression enrolled at 29 sites were randomized to mifepristone or placebo for 7 days. The primary outcome was rapid and sustained response, defined as a 50% or greater decrease in Brief Psychiatric Rating Scale-Positive Symptom Subscale scores at the end of treatment (day7) and 49 days later (day 56). Cochran-Mantel-Haenszel compared proportions of responders to mifepristone versus placebo adjusting for site. Exploratory anal... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2291804 Sat, 21 Mar 2009 04:00:00 +0100 2291804 http://www.medworm.com/index.php?rid=2495446&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000354%2Fabstract%3Frss%3Dyes 1,437,180 new cancer cases were projected in 2008 in the U.S., prostate, female breast, lung, and colorectal cancer representing the most frequent solid tumors. The one side of the coin is global statistics the other side is the successful prevention and treatment of solid tumors requiring the acceptance that these are not single diseases. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495446 Thu, 12 Mar 2009 00:00:00 +0100 2495446 http://www.medworm.com/index.php?rid=2265996&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19281871%26dopt%3DAbstract Authors: Chen X, Li Y, Zheng H, Hu K, Zhang H, Zhao L, Li Y, Liu L, Mang L, Yu S PMID: 19281871 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2265996 Mon, 09 Mar 2009 04:00:00 +0100 2265996 http://www.medworm.com/index.php?rid=2495453&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.journals.elsevierhealth.com%2Fperiodicals%2Fconcli%2Farticle%2FPIIS1551714409000342%2Fabstract%3Frss%3Dyes Abstract: Background:: National data find glycemic control is within target (A1c (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2495453 Mon, 09 Mar 2009 00:00:00 +0100 2495453 http://www.medworm.com/index.php?rid=2265998&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19275947%26dopt%3DAbstract CONCLUSIONS: Aggressive outreach and screening is likely not feasible for broader dissemination in everyday practice settings and recruits individuals with more similar demographic and clinical characteristics to those recruited through more abbreviated and realistic screening procedures than anticipated. PMID: 19275947 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2265998 Sat, 07 Mar 2009 05:00:00 +0100 2265998 http://www.medworm.com/index.php?rid=2265997&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19275948%26dopt%3DAbstract CONCLUSIONS: PRO instruments are used in a significant percentage but minority of clinical trials. Trial registries should require that all PRO instruments be identified, including the concepts or outcomes they are intended to measure. PMID: 19275948 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2265997 Sat, 07 Mar 2009 05:00:00 +0100 2265997 http://www.medworm.com/index.php?rid=2222649&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19244624%26dopt%3DAbstract Authors: Fouad MN PMID: 19244624 [PubMed - in process] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2222649 Sat, 28 Feb 2009 21:17:33 +0100 2222649 http://www.medworm.com/index.php?rid=2222648&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19245857%26dopt%3DAbstract Authors: Armbruster C PMID: 19245857 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2222648 Mon, 23 Feb 2009 05:00:00 +0100 2222648 http://www.medworm.com/index.php?rid=2210693&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19232549%26dopt%3DAbstract Authors: Behrendt CE, Gehan EA 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, vincristine, and prednisone (a combination abbreviated as OAP) for adult acute leukemia, when standard treatment was adriamycin plus OAP. We carried o... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2210693 Mon, 16 Feb 2009 05:00:00 +0100 2210693 http://www.medworm.com/index.php?rid=2144642&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19171204%26dopt%3DAbstract Authors: Schmitz KH, Troxel AB, Cheville A, Grant LL, Bryan CJ, Gross C, Lytle LA, Ahmed RL 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 shown to be associated with worse clinical course for women with lymphedema. We hypot... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2144642 Thu, 08 Jan 2009 05:00:00 +0100 2144642 http://www.medworm.com/index.php?rid=2112238&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19146991%26dopt%3DAbstract Authors: Glas CA, Geerlings H, van de Laar MA, Taal E Patient-relevant outcomes, such as impairments, disability and health-related quality of life, are becoming increasingly popular as outcome measures in clinical research. These outcomes are generally assessed using questionnaires. In a longitudinal randomized clinical trial where the outcome is measured by a questionnaire or some other instrument consisting of a set of discretely scored items, treatment effects can be analyzed using item response theory. The problem addressed is how to take the estimation error in the estimates of the latent outcome variables into account in the estimation of the treatment effects. Three approaches are compared: plausible value imputation (PVI), concurrent marginal maximum likelihood (MML) estimatio... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2112238 Wed, 24 Dec 2008 05:00:00 +0100 2112238 http://www.medworm.com/index.php?rid=2094855&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19130902%26dopt%3DAbstract Authors: Jahn-Eimermacher A, Ingel K Adaptive designs allow a clinical trial design to be changed according to interim findings without inflating type I error. The Inverse Normal method can be considered as an adaptive generalization of classical group sequential designs. The use of the Inverse Normal method for censored survival data was demonstrated only for the logrank statistic. However, the logrank statistic is inefficient in the presence of nuisance covariates affecting survival. We demonstrate, how the Inverse Normal method can be applied to Cox regression analysis. The required independence between test statistics of the different stages of the trial can be obtained by two different approaches. One is using the independent increment structure of the score process. The other use... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2094855 Tue, 16 Dec 2008 05:00:00 +0100 2094855 http://www.medworm.com/index.php?rid=2094854&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19130903%26dopt%3DAbstract This article describes the rationale and design of this randomized trial, focusing on several key design features of potential interest to researchers in the field of female pelvic floor disorders and others conducting randomized surgical trials. PMID: 19130903 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2094854 Tue, 16 Dec 2008 05:00:00 +0100 2094854 http://www.medworm.com/index.php?rid=2027210&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19063996%26dopt%3DAbstract CONCLUSION: Our results show that the number of zeros after the decimal point in a p-value from an observed sample cannot and should not be used to gauge the adequacy of sample size for a future study that is expected to have sufficient power to detect an effect as big as the observed. PMID: 19063996 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2027210 Wed, 03 Dec 2008 05:00:00 +0100 2027210 http://www.medworm.com/index.php?rid=2027211&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19059362%26dopt%3DAbstract Authors: Albert JM, Maddux BN, Riley DE, Maciunas RJ A recent pilot crossover study of deep brain stimulation for Tourette syndrome involved the counting of motor and sonic tics from video recordings of patients. The evaluation of a five-minute video (divided into ten 30-second segments) in each of eight intervention states per patient was found to be very tedious and time-consuming. The present study sought to determine the statistical implications of reducing this data collection burden. To make maximal use of data from the small sample (n=5) pilot study, we fit linear mixed effects models to the tic count data. As suggested by an empirical examination of within-person correlations, a novel random effects covariance structure, which we refer to as a 'partitioned random effects model'... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=2027211 Tue, 18 Nov 2008 05:00:00 +0100 2027211 http://www.medworm.com/index.php?rid=1980908&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19013540%26dopt%3DAbstract Contemp Clin Trials. 2008 Nov 8; Authors: Drennan K, Kazol B PMID: 19013540 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1980908 Sat, 08 Nov 2008 05:00:00 +0100 1980908 http://www.medworm.com/index.php?rid=1980910&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19013258%26dopt%3DAbstract Authors: Li J, Wong WK In a recently concluded multi-center two-armed clinical trial for Scleroderma patients, results from a variety of analyses based on parametric models showed that late phase patients benefited from the bovine collagen treatment at 15 months and the placebo group did not. However, the cutoff time for defining early or late phase patients was somewhat arbitrary and sample size for late phase patients was small in the two groups. We apply a combination of semi-parametric and parametric approaches to further ascertain treatment efficacy and address modeling issues related to the choice of the cutoff and the scientific hypothesis of interest. We compare results with those obtained from parametric models and demonstrate how semi-parametric methods can help to better ide... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1980910 Sat, 01 Nov 2008 04:00:00 +0100 1980910 http://www.medworm.com/index.php?rid=1980909&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19013259%26dopt%3DAbstract CONCLUSIONS: That there was a decrease for the celecoxib over the placebo group adds to the body of evidence that relates COX-2 specific inhibitors and cancer incidence. PMID: 19013259 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1980909 Sat, 01 Nov 2008 04:00:00 +0100 1980909 http://www.medworm.com/index.php?rid=1960835&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19000782%26dopt%3DAbstract Authors: Chen Z, Krailo MD, Sun J, Azen SP The traditional algorithm-based 3+3 designs are most widely used for their practical simplicity in phase I clinical trials. At early stage, a common belief was that the expected toxicity level (ETL) at the maximum tolerated dose (MTD) should be 33% [Storer, B. Design and analysis of phase I clinical trials. Biometrics 1989;45;925-937, Gorden, N., Willson, J. Using toxicity grades in the design and analysis of cancer phase I clinical trials. Statistics in Medicine 1992; 11: 2603-2075, Mick, R. Phase I Clinical Trial Design. In Schilsky, R., Milano, G., Ratain, M., eds. Principles of Antineoplastic Drug Development and Pharmacology New York, NY: Marcel Dekker, 1996; 29-36]. Recently, Kang and Ahn [Kang, S., Ahn, C. The expected toxicity rate at ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1960835 Wed, 29 Oct 2008 04:00:00 +0100 1960835 http://www.medworm.com/index.php?rid=1951995&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18996225%26dopt%3DAbstract Authors: Lebrasseur NK, Lajevardi N, Miciek R, Mazer N, Storer TW, Bhasin S The TOM study is the first, single-site, placebo-controlled, randomized clinical trial designed to comprehensively determine the effects of testosterone administration on muscle strength and physical function in older men with mobility limitations. A total of 252 community dwelling individuals aged 65 and older with low testosterone levels and self-reported limitations in mobility and short physical performance battery (SPPB) score between 4 and 9 will be randomized to receive either placebo or testosterone therapy for 6 months. The primary objective is to determine whether testosterone therapy improves maximal voluntary muscle strength as quantified by the one repetition maximum. Secondary outcomes will includ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1951995 Wed, 29 Oct 2008 04:00:00 +0100 1951995 http://www.medworm.com/index.php?rid=1934043&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18977313%26dopt%3DAbstract Authors: Resnik DB This commentary argues that, despite extensive critiques of informed consent documents, there are several ethical and legal reasons for investigators and IRB members to take these documents seriously. PMID: 18977313 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1934043 Wed, 29 Oct 2008 04:00:00 +0100 1934043 http://www.medworm.com/index.php?rid=1934042&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18977314%26dopt%3DAbstract CONCLUSIONS:: Using this technique, we were successfully able to find a randomization scheme that allocated 32 primary care practices into intervention and control groups in a way that preserved balance across 7 baseline covariates. This process may be a useful tool for ensuring covariate balance within moderately large cluster randomized trials. PMID: 18977314 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1934042 Wed, 22 Oct 2008 04:00:00 +0100 1934042 http://www.medworm.com/index.php?rid=1859614&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18835461%26dopt%3DAbstract Authors: Glass HE The FDA database on investigators completing the 1572 form constitutes a rich database of practicing investigators. Within the most recent three-year period, roughly half of all the principal investigators appear only once in the 1572 database, which leads some to conclude that many of these investigators have only conducted one study and may be reluctant to be involved in a second clinical trial. Part of the misunderstanding about these investigators comes from the incorrect notion that 1572 forms are required to be submitted to the FDA. Drawing upon a random sample of 762 US investigators, the study concludes that many of the one-time 1572 investigators have participated as principal investigators in far more than one clinical trial, although the number is less than... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1859614 Thu, 18 Sep 2008 04:00:00 +0100 1859614 http://www.medworm.com/index.php?rid=1844808&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18824135%26dopt%3DAbstract CONCLUSIONS: Our collaborative approach was successful in recruiting and retaining ethnically diverse study participants who reside in a rural underserved area of South Carolina. Differences in baseline characteristics and retention by ethnicity and gender were found. Successful translational research must allow for a collaborative approach addressing factors at the level of the community health center, key personnel, and patients in an effort to build trust for the purpose of advancing the science of translating research to practice. PMID: 18824135 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1844808 Tue, 16 Sep 2008 04:00:00 +0100 1844808 http://www.medworm.com/index.php?rid=1844809&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18824134%26dopt%3DAbstract Authors: Ueshima K, Oba K, Yasuno S, Fujimoto A, Sato T, Fukiyama K, Azuma J, Ogihara T, Saruta T, Nakao K, Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) trial was conducted to compare the effects of the angiotensin II receptor blocker (ARB) candesartan and the calcium channel blocker (CCB) amlodipine on the incidence of cardiovascular (CV) events in Japanese high-risk hypertensive patients. After 3.2years follow-up, CV events rate was 17.6-17.7 per 1000 person-years in each group, which was much lower than we expected. Since it has not been known whether the same efficacy of two drugs is sustained beyond the current trial, a longer follow-up period will be needed. The Steering Committee of CASE-J trial decided to extend the trial for 3years as an observational st... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1844809 Sat, 13 Sep 2008 04:00:00 +0100 1844809 http://www.medworm.com/index.php?rid=1841099&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18822390%26dopt%3DAbstract Authors: Cui YL, Meng MB, Tang H, Lei XZ PMID: 18822390 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1841099 Thu, 11 Sep 2008 04:00:00 +0100 1841099 http://www.medworm.com/index.php?rid=1825848&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18804555%26dopt%3DAbstract Authors: Chalasani NP, Sanyal AJ, Kowdley KV, Robuck PR, Hoofnagle J, Kleiner DE, Unalp A, Tonascia J, BACKGROUND:: Non-alcoholic steatohepatitis (NASH) is a common liver disease associated with obesity and diabetes. NASH is a progressive disorder that can lead to cirrhosis and liver failure. Insulin resistance and oxidative stress are thought to play important roles in its pathogenesis. There is no definitive treatment for NASH. OBJECTIVES:: PIVENS is conducted to test the hypotheses that treatment with pioglitazone, a thiazolidinedione insulin sensitizer, or vitamin E, a naturally available antioxidant, will lead to improvement in hepatic histology in non-diabetic adults with biopsy proven NASH. DESIGN:: PIVENS is a randomized, multicenter, double-masked, placebo-controlled trial to... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1825848 Wed, 10 Sep 2008 04:00:00 +0100 1825848 http://www.medworm.com/index.php?rid=1825844&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18809512%26dopt%3DAbstract CONCLUSION:: The recurrence free survival is not a good surrogate for overall survival in clinical trials with non significant treatment effects and moderate for significant treatment effects. This shows that the level of significance of treatment effect should be taken into account in validation process of surrogate endpoints. PMID: 18809512 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1825844 Tue, 09 Sep 2008 04:00:00 +0100 1825844 http://www.medworm.com/index.php?rid=1825847&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18804556%26dopt%3DAbstract CONCLUSIONS: Automated notifications can facilitate consistent, customized, and timely communication of relevant protocol information to potential research subjects. Our registry and supporting communication tools demonstrate a significant positive impact on study participation rates in our network. The use of the internet and automated notifications make the system scalable to support many protocols and registrants. PMID: 18804556 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1825847 Sun, 07 Sep 2008 04:00:00 +0100 1825847 http://www.medworm.com/index.php?rid=1825845&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18805510%26dopt%3DAbstract Authors: der Horst CV, Chasela C, Ahmed Y, Hoffman I, Hosseinipour M, Knight R, Fiscus S, Hudgens M, Kazembe P, Bentley M, Adair L, Piwoz E, Martinson F, Duerr A, Kourtis A, Loeliger AE, Tohill B, Ellington S, Jamieson D, In order to evaluate strategies to reduce HIV transmission through breast milk and optimize both maternal and infant health among HIV-infected women and their infants, we designed and implemented a large, randomized clinical trial in Lilongwe, Malawi. The development of protocols for large, randomized clinical trials is a complicated and lengthy process often requiring alterations to the original research design. Many factors lead to delays and changes, including study site-specific priorities, new scientific information becoming available, the involvement of nationa... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1825845 Sun, 07 Sep 2008 04:00:00 +0100 1825845 http://www.medworm.com/index.php?rid=1825846&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18805509%26dopt%3DAbstract CONCLUSION: The IVRS psychophysical peripheral cue call frequency supported the ELM as a route to persuasion. The results also support OD strategy for optimal compliance. Models suggest specific indicators to enhance compliance with medication dosing and electronic patient diaries to improve health outcomes and data integrity respectively. PMID: 18805509 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1825846 Sat, 06 Sep 2008 04:00:00 +0100 1825846 http://www.medworm.com/index.php?rid=1802777&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18793753%26dopt%3DAbstract DISCUSSION: Understanding the disparity in treatment protocols is of value in the construction and maintenance of quality control in an actual randomized clinical trial setting. More work is recommended in the preparation of clinical trials and the understanding of clinical decision-making because these disparate factors may dramatically impact the generalizability of clinical trial results. PMID: 18793753 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1802777 Sun, 31 Aug 2008 04:00:00 +0100 1802777 http://www.medworm.com/index.php?rid=1788763&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18783735%26dopt%3DAbstract CONCLUSIONS: PIVOT enrolled an ethnically diverse population representative of men diagnosed with prostate cancer in the United States. Results will yield important information regarding the relative effectiveness and harms of surgery compared to watchful waiting for men with predominately PSA detected clinically localized prostate cancer. PMID: 18783735 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1788763 Sat, 23 Aug 2008 04:00:00 +0100 1788763 http://www.medworm.com/index.php?rid=1779315&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18775798%26dopt%3DAbstract Authors: Larkey LK, Gonzalez JA, Mar LE, Glantz N Increasing minority participation in cancer research is an ethical and statistical necessity for gaining population-specific knowledge of cancer prevention, screening, and treatment. Locating and recruiting eligible and willing minority participants presents unique structural and cultural/linguistic challenges. Community Based Participatory Research provides a viable set of principles for facilitating recruitment in hard-to-recruit communities. We focus on the specific challenge of recruiting and engaging low-income and underinsured Latina women in cancer prevention education research, and present community-based strategies used to recruit women into a recently completed study in Arizona, Juntos en la Salud (Together in Health). Communi... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1779315 Sat, 23 Aug 2008 04:00:00 +0100 1779315 http://www.medworm.com/index.php?rid=1754782&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18761427%26dopt%3DAbstract CONCLUSION: By utilizing telephone-based follow-up procedures and adapting our easy-to-use pre-defined multi-step approach, researchers can maximize patient data retention in longitudinal studies. PMID: 18761427 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1754782 Tue, 12 Aug 2008 04:00:00 +0100 1754782 http://www.medworm.com/index.php?rid=1746386&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18723124%26dopt%3DAbstract We present in this article a simulation technique to estimate the ICC value and its distribution for known binary outcome variables and a varying number of clusters and cluster sizes. We applied this technique to estimate ICC values and confidence intervals for a multi-country trial assessing the effect of neonatal resuscitation to decrease seven-day neonatal mortality, where communities within a country were clusters. This simulation technique can be used to estimate the possible ranges of the ICC values and to help to design an appropriately powered trial. PMID: 18723124 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1746386 Tue, 05 Aug 2008 04:00:00 +0100 1746386 http://www.medworm.com/index.php?rid=1746388&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18721901%26dopt%3DAbstract CONCLUSION: Recruitment of minority and underserved populations to clinical trials is necessary to increase study generalizbility and reduce health disparities. Our results demonstrate the importance of flexible study designs which allow adaptation to recruitment challenges. These experiences also highlight the importance of involving community members and reducing participant burden to achieve success in recruiting individuals from minority and underserved populations. PMID: 18721901 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1746388 Thu, 31 Jul 2008 04:00:00 +0100 1746388 http://www.medworm.com/index.php?rid=1746387&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18721902%26dopt%3DAbstract This article presents the recruitment and retention challenges experienced in two clinical trials: one involving participants experiencing a first episode of depression and one involving participants experiencing a first episode psychosis. Challenges with recruitment and retention are identified and reviewed at both the patient level and clinician level. Strategies that were implemented to enhance recruitment and retention in these two studies are also discussed. Finally, ethical issues to consider when implementing these strategies are also highlighted. PMID: 18721902 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1746387 Thu, 31 Jul 2008 04:00:00 +0100 1746387 http://www.medworm.com/index.php?rid=1729485&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18718555%26dopt%3DAbstract CONCLUSION: Reasons for recruitment difficulties in trials involving patients with severe mental illness include issues that occur in trials in general, but others are more specific to these patients. Clinician and patient involvement in the study design may improve recruitment in future similar trials. PMID: 18718555 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1729485 Thu, 31 Jul 2008 04:00:00 +0100 1729485 http://www.medworm.com/index.php?rid=1729484&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18718556%26dopt%3DAbstract CONCLUSION:: Our proposed method can help researchers identify patient factors that are associated with differential effect. Those factors are potential areas for further clinical investigation or for constructing subgroups for sub-analysis. PMID: 18718556 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1729484 Fri, 25 Jul 2008 04:00:00 +0100 1729484 http://www.medworm.com/index.php?rid=1709288&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18703164%26dopt%3DAbstract Authors: Stallard N, Cockey L A common approach to the design of phase II clinical trials in oncology is to conduct a two-stage trial so as to control type I and type II error rates. A number of researchers have proposed methods for the design of such trials when the response can take one of a number of ordered values such as tumor response, stable disease or progressive disease. In this case, the problem may be formulated as that of testing a complex null hypothesis. Control of the type I error rate thus requires specification of the null region and construction of a test that limits the maximum error rate over this region. In this paper we propose that the null region should be bounded by a line in the two-dimensional parameter space for the setting with a response with three levels ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1709288 Thu, 24 Jul 2008 04:00:00 +0100 1709288 http://www.medworm.com/index.php?rid=1709287&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18703165%26dopt%3DAbstract In conclusion, reporting of the full CONSORT data remains inconsistent. We recommend that journals continue to support the CONSORT statement and ensure that adequate information is provided upon submission before commencing the peer review process. The presentation of clear, precise data will ensure that readers are able to better interpret the applicability of findings. PMID: 18703165 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1709287 Thu, 24 Jul 2008 04:00:00 +0100 1709287 http://www.medworm.com/index.php?rid=1709286&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18703166%26dopt%3DAbstract The objective of this Trial of Education And Compliance in Heart failure patients (TEACH) was to measure in patients with heart failure who were hospitalized and then discharged into the community, the impact of a comprehensive outpatient educational intervention on: 1) a composite endpoint of mortality, readmissions and visits to the emergency room for all causes, 2) the impact of the intervention on health-related quality of life, 3) the impact of the intervention on compliance to medication and 4) the economic impact of providing such an intervention to patients. RESEARCH DESIGN: This was a prospective cluster randomized controlled clinical trial in patients who were admitted to hospital with a diagnosis of heart failure (HF). Patients were stratified by reason for admission to hospital... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1709286 Thu, 24 Jul 2008 04:00:00 +0100 1709286 http://www.medworm.com/index.php?rid=1649095&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18644468%26dopt%3DAbstract In conclusion, the APEX library is an example of successful collaboration among academic trial leaders, site investigators, and pharmaceutical sponsors. The operational paradigm of this effort should be considered in future investigations so that important advances in clinical care of disease can be realized efficiently. PMID: 18644468 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1649095 Tue, 01 Jul 2008 04:00:00 +0100 1649095 http://www.medworm.com/index.php?rid=1646060&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18639651%26dopt%3DAbstract Authors: Perneger TV Clinical trials typically examine associations between an intervention and the occurrence of a clinical event. The association is often reported as a relative risk, more rarely as an odds ratio. Unfortunately, when the scientific interest lies with the ratio of incidence rates, both these statistics are inaccurate: the odds ratio is too extreme, and the relative risk too conservative. These biases are particularly strong when the outcomes are common. This paper describes an alternative statistic, the ratio of logarithms of event-free proportions (or relative log survival), which is simple to compute yet unbiased vis-à-vis the relative hazard. A formula to compute the sampling error of this statistic is also provided. Multivariate analysis can be conducted usin... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1646060 Fri, 27 Jun 2008 04:00:00 +0100 1646060 http://www.medworm.com/index.php?rid=1646059&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18639652%26dopt%3DAbstract In conclusion, these results suggest that health-related factors, and not psychosocial perceptions, have predominant influence on research participation among African Americans. PMID: 18639652 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1646059 Fri, 27 Jun 2008 04:00:00 +0100 1646059 http://www.medworm.com/index.php?rid=1603116&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18606249%26dopt%3DAbstract CONCLUSION: Daily process assessment improves the ability to detect an early antidepressant response. PMID: 18606249 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1603116 Tue, 17 Jun 2008 04:00:00 +0100 1603116 http://www.medworm.com/index.php?rid=1603115&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18606250%26dopt%3DAbstract This article summarizes the design of the intervention. PMID: 18606250 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1603115 Wed, 11 Jun 2008 04:00:00 +0100 1603115 http://www.medworm.com/index.php?rid=1560938&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18585481%26dopt%3DAbstract Authors: Happ MB, Sereika S, Garrett K, Tate J This paper describes a quasi-experimental three-phase sequential cohort design used in the Study of Patient-Nurse Effectiveness with Assisted Communication Strategies (SPEACS) to test two interventions to improve nurse-patient communication in the intensive care unit (ICU). The sample consists of 10 nurses and 30 nonspeaking ICU patients in each phase (total n=90 nurse-patient dyads). Observational techniques (video recording, transcription, and rating) measure nurse-patient communication performance. Descriptive adn covariate data are collected through clinical assessment tools, questionnaires, and field notes. We discuss the practical and scientific considerations in constructing and implementing this type of clinical trial. Specifically... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1560938 Sat, 07 Jun 2008 04:00:00 +0100 1560938 http://www.medworm.com/index.php?rid=1554482&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18582601%26dopt%3DAbstract We present statistical details for estimating an in vitro 50% inhibitory concentration (IC(50)), based on several models for continuous response data fit to bone-marrow endothelial cell lines replicated in vehicle and at several dose increments. Nonlinear models are fit via maximum likelihood assuming normal errors, and primary attention is given to exponential, Gompertz, and scaled logistic dose-response curves that admit increasing or decreasing monotonic and sigmoidal patterns. Careful consideration is given to dose axis scaling, comparative model fit via mean squared error and graphical assessment, analogues to weighted least squares analysis to address heterogeneity of variance across doses, and potential hormetic effects. Standard error estimation is discussed in detail, highlighting... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1554482 Fri, 06 Jun 2008 04:00:00 +0100 1554482 http://www.medworm.com/index.php?rid=1546749&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18577469%26dopt%3DAbstract We describe the actions taken and the relative success/failure of such actions. PMID: 18577469 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1546749 Fri, 06 Jun 2008 04:00:00 +0100 1546749 http://www.medworm.com/index.php?rid=1543377&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18573350%26dopt%3DAbstract CONCLUSIONS: Elucidating the relationship between individual characteristics and participation is essential for evaluating nonresponse bias, correcting for it, and for planning and implementing recruitment strategies. PMID: 18573350 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1543377 Thu, 05 Jun 2008 04:00:00 +0100 1543377 http://www.medworm.com/index.php?rid=1543379&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18571477%26dopt%3DAbstract Authors: Daimon T Bayesian methodologies have been used for interim analyses of clinical trial data. In Bayesian interim analyses, decisions regarding the continuation of a trial are guided by a Bayesian model or indices, e.g., the predictive probability derived from it that specifies the conditions under which the clinical trial results might be judged sufficiently convincing to allow early stopping. Thus, its appropriateness for making such decisions depends on whether the model or the indices are reliable. In this paper we describe the use of both prior- and posterior- predictive checking approaches as a diagnostic tool for assessing the reliability of the model or indices on which the decision making is based. The proposed approach is illustrated with three examples, one of which i... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1543379 Tue, 20 May 2008 04:00:00 +0100 1543379 http://www.medworm.com/index.php?rid=1543378&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18571991%26dopt%3DAbstract CONCLUSIONS: The analysis of biological/circadian rhythms is usually handled by Cosinor rhythmometry method. However, in FTD this is simply not possible. In this case, we propose to adapt the Cosinor method to the Weibull proportional hazard model. The advantage of the proposed method is its ability to model survival data. This method is not limited to breast cancer data, and may be applied to any biological rhythms linked to right censored data. PMID: 18571991 [PubMed - as supplied by publisher] (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=1543378 Sun, 18 May 2008 04:00:00 +0100 1543378