Contemporary Clinical Trials RSS feed: Articles in Press. Contemporary Clinical Trials is an international journal that publishes manuscripts pertaining to the design, methods and operational aspects of clinical trials. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioral science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words in the following subject areas will be published: Unusual design features of specific trials that may be applicable to other studies Organizational structures that facilitate multicenter investigations General or specific design and operating features of data processing systems used for maintaining data bases in clinical trials Medical, legal, and ethical issues in the conduct of clinical trials Management of multicenter investigations Methods for assessing patient adherence Design of case report forms and other data collection methods for clinical trials Quality assurance procedures for error detection in the data generation and processing procedures in clinical trials Data auditing practices in clinical trials Methods for collecting and reporting adverse event data in clinical trials Regulatory requirements for clinical trials Patient involvement in the design of clinical trials Statistical methods for clinical trials Historical review of clinical trials Methods and case examples of monitoring clinical trials for evidence of adverse or beneficial treatment effects Cost assessment of procedures used for data generation, processing, and auditing in clinical trials Assessment of the impact of clinical trials on the practice of medicine http://www.journals.elsevierhealth.com/periodicals/concli//inpress?rss=yesElsevier Inc.en © 2009 Published by Elsevier Inc. Contemporary Clinical Trials1551-71442009-11-20 © 2009 Published by Elsevier Inc. healthpermissions@elsevier.comhttp://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001773/abstract?rss=yesAbstract: 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 minimal disclosure standard found in the U.S. federal regulations, less than a third met the reasonable person standard, a widely accepted principle endorsed by the common law and various ethics guidelines and documents. There was a statistically significant difference between the alternative discussions in local and model forms (P<0.0014). The alternatives discussions in local informed consent documents were more likely to receive higher scores than those in model consent documents, with an odds-ratio of 3.5 to 1.Evaluating the quality of information about alternatives to research participation in oncology consent forms - Corrected ProofDavid B. Resnik, Daniel Patrone, Shyamal Peddada10.1016/j.cct.2009.11.001Contemporary Clinical Trials (2009)2009-11-20Contemporary Clinical Trials2009-11-20http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001785/abstract?rss=yesAbstract: Background: International clinical trials can provide scientific and logistic benefits in spite of the many challenges. Determining whether a country, especially a developing country, is an appropriate location for the research should include in-country consultation and partnering to assess its social value for the population; that treatments are relevant for the population under study; and that the research infrastructure and ethical oversight are adequate. Collaboration increases the likelihood of study success and helps ensure that benefits accrue to recruited populations and their community.Purpose: This paper describes our experiences on a bi-national study and may provide guidance for those planning to engage in future collaborations.Methods: A Thai and United States team collaborated to develop and implement a phase II clinical trial for HIV-associated cryptococcal meningitis to assess safety and tolerability of combination therapy vs. standard treatment. Clinical and cultural differences, regulatory hurdles and operational issues were addressed before and during the study to ensure a successful collaboration between the 2 groups.Results: The international multicenter study allowed for more rapid enrollment, reduced costs to complete the study, sharing of the benefits of research, greater generalizability of results and capacity building in Thailand; quality metrics in Thailand were equivalent to or better than those in the U.S.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.International collaboration between US and Thailand on a clinical trial of treatment for HIV-associated cryptococcal meningitis - Corrected ProofL.O. Zimmer, T.L. Nolen, S. Pramanpol, D. Wallace, M.E. Walker, P. Pappas, P. Chetchotisakd10.1016/j.cct.2009.11.002Contemporary Clinical Trials (2009)2009-11-19Contemporary Clinical Trials2009-11-19http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001736/abstract?rss=yesAbstract: 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 included in the study design process. Main recruitment outcomes were number overall and number of African Americans recruited by each strategy. Of the 810 randomized PREMIER participants, 279 (34%) were African American with site-specific percentages of 56%, 46%, 27%, and 8%. Of African Americans recruited, 151 (54%) were from mass distribution of brochures (mailed letter, flyer included in Val-Pak coupons, or other), 66 (24%) from mass media (printed article, radio, TV story or ads, 52 (19%) from word of mouth, and 10 (3%) from email/website and screening events combined. Yields for Non-Hispanic Whites were 364 (69%) from brochures, 71 (13%) from mass media, 49 (9%) from word of mouth and 47 (9%) from email/website and screening events. Mass distribution of brochures was relatively more effective with Non-Hispanic Whites, while African Americans responded relatively better to other recruitment strategies.Overall and minority-focused recruitment strategies in the PREMIER multicenter trial of lifestyle interventions for blood pressure control - Corrected ProofBetty M. Kennedy, Shiriki Kumanyika, Jamy D. Ard, Patrice Reams, Cheryl A. Johnson, Njeri Karanja, Jeanne B. Charleston, Lawrence J. Appel, Vallerie Maurice, David W. Harsha10.1016/j.cct.2009.10.002Contemporary Clinical Trials (2009)2009-11-18Contemporary Clinical Trials2009-11-18http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS155171440900175X/abstract?rss=yesAbstract: 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 for use in the second stage.A two-stage algorithm for designing phase I cancer clinical trials for two new molecular entities - Corrected ProofZheng Su10.1016/j.cct.2009.10.004Contemporary Clinical Trials (2009)2009-11-18Contemporary Clinical Trials2009-11-18SHORT COMMUNICATIONhttp://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001761/abstract?rss=yesI 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.Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study - Corrected ProofZhengwu Lu10.1016/j.cct.2009.10.005Contemporary Clinical Trials (2009)2009-11-18Contemporary Clinical Trials2009-11-18LETTER TO THE EDITORhttp://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001797/abstract?rss=yesAbstract: Background: Incidence and mortality from skin cancers including melanoma are highest among men 50years or older. Thorough skin self-examination may be beneficial to improve skin cancer outcomes.Objectives: To develop and conduct a randomized-controlled trial of a video-based intervention to improve skin self-examination behavior among men 50years or older.Methods: Pilot work ascertained appropriate targeting of the 12-minute intervention video towards men 50years or older. Overall, 968 men were recruited and 929 completed baseline telephone assessment. Baseline analysis assessed randomization balance and demographic, skin cancer risk and attitudinal factors associated with conducting a whole-body skin self-examination or receiving a whole-body clinical skin examination by a doctor during the past 12months.Results: Randomization resulted in well-balanced intervention and control groups. Overall 13% of men reported conducting a thorough skin self-examination using a mirror or the help of another person to check difficult to see areas, while 39% reported having received a whole-body skin examination by a doctor within the past 12months. Confidence in finding time for and receiving advice or instructions by a doctor to perform a skin self-examination were among the factors associated with thorough skin self-examination at baseline.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.The skin awareness study: Promoting thorough skin self-examination for skin cancer among men 50years or older - Corrected ProofM. Janda, P.D. Baade, P.H. Youl, J.F. Aitken, D.C. Whiteman, L. Gordon, R.E. Neale10.1016/j.cct.2009.11.003Contemporary Clinical Trials (2009)2009-11-18Contemporary Clinical Trials2009-11-18http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001748/abstract?rss=yesAbstract: 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 field trial for coronary heart disease.Bias analysis of the instrumental variable estimator as an estimator of the average causal effect - Corrected ProofYasutaka Chiba10.1016/j.cct.2009.10.003Contemporary Clinical Trials (2009)2009-11-16Contemporary Clinical Trials2009-11-16http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001724/abstract?rss=yesThe 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.Corrigendum to “A Multisite Trial of Mifepristone for the Treatment of Psychotic Depression: A Site-by-Treatment Interaction” [Contemp. Clin. Trials 30 (2009) 284-288] - Corrected ProofChristine M. Blasey, Charles DeBattista, Robert Roe, Thaddeus Block, Joseph K. Belanoff10.1016/j.cct.2009.10.001Contemporary Clinical Trials (2009)2009-11-09Contemporary Clinical Trials2009-11-09CORRIGENDUMhttp://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001554/abstract?rss=yesAbstract: Background: African American women are at increased risk for CVD morbidity and mortality relative to white women. Physical inactivity and poor dietary habits are modifiable health behaviors shown to reduce CVD risk. Community health centers have the potential to reach large numbers of African Americans to modify their risk for CVD, yet few lifestyle counseling interventions have been conducted in this setting.Methods: The HHER Lifestyle trial is a randomized controlled trial to compare the effects of a standard care intervention (provider counseling, nurse goal setting, and educational materials) to a comprehensive intervention (standard care intervention plus 12months of telephone counseling and tailored print materials) on changes in physical activity and dietary fat consumption in financially disadvantaged African American women at 6 and 12months. Secondary outcomes are body mass index, central adiposity, and total cholesterol. Potential mediators of outcome are self-efficacy for overcoming barriers, social support, and decisional balance.Results: African American women (N=266; 130 standard care, 136 comprehensive intervention) 35years and older from nine clinics within two community health centers were enrolled. Most participants were overweight or obese with existing chronic health conditions.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.Heart Healthy and Ethnically Relevant (HHER) Lifestyle trial for improving diet and physical activity in underserved African American women - Corrected ProofDeborah Parra-Medina, Sara Wilcox, Dawn K. Wilson, Cheryl L. Addy, Gwen Felton, Mary Beth Poston10.1016/j.cct.2009.09.006Contemporary Clinical Trials (2009)2009-10-19Contemporary Clinical Trials2009-10-19http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001530/abstract?rss=yesAbstract: Nearly, one-fifth of childhood cancer survivors (CCSs) smoke cigarettes. Because CCSs are already at greater medical smoking-related risks, targeting them for smoking cessation efforts is a high priority. One of the major challenges with smoking cessation in CCSs is how to reach such a geographically dispersed population. 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 same six telephone sessions and provision of 2weeks of NRT. Both groups will receive two follow-up phone calls at 8weeks and 1year after enrollment to assess their smoking status. The primary outcome measure is cotinine-validated self-reported smoking abstinence at 1-year follow-up. Results from this study will provide the first evidence about the efficacy of intensive QL cessation intervention in this high-risk population. Such evidence can lead as well to the dissemination of this intervention to other medically compromised populations.Trial design: The St. Jude Children's Research Hospital Cancer Survivors Tobacco Quit Line study - Corrected ProofTaghrid Asfar, Robert C. Klesges, Stacy D. Sanford, Deborah Sherrill-Mittleman, Leslie L. Robison, Melissa M. Hudson, Grant Somes, James M. Boyett, Harry Lando10.1016/j.cct.2009.09.004Contemporary Clinical Trials (2009)2009-10-12Contemporary Clinical Trials2009-10-12http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001542/abstract?rss=yesAbstract: 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.An electronic regulatory document management system for a clinical trial network - Corrected ProofWenle Zhao, Valerie Durkalski, Keith Pauls, Catherine Dillon, Jaemyung Kim, Deneil Kolk, Robert Silbergleit, Valerie Stevenson, Yuko Palesch10.1016/j.cct.2009.09.005Contemporary Clinical Trials (2009)2009-10-12Contemporary Clinical Trials2009-10-12http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001566/abstract?rss=yesAbstract: Background: Subject recruitment and retention in clinical leiomyoma trials is challenging. We evaluated strategies to increase patient enrollment and completion in leiomyoma trials.Materials and methods: Randomized trials for treatment of symptomatic leiomyoma published from 2000 through 2008 were evaluated and thirteen trials were selected. Subject enrollment and completion rates, recruitment methods and reasons for patient drop-out were assessed.Results: Recruitment by study personnel or clinic staff during evaluation for symptomatic leiomyoma was the most common strategy for enrollment. Additional methods included local media, internet postings and physician referrals. Seven to 85% of patients enrolled after screening, with a median enrollment of 70%. Sixty-five to 100% of patients completed the study after enrollment with a median completion rate of 89%. Reasons for drop-out at the screening stage included failure to meet inclusion criteria, patient refusal and patient preference for specific treatment. Commonly reported reasons for drop-out after enrollment were refusal of treatment following randomization, adverse reaction to study intervention and non-compliance with study protocol or follow-up visits.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.Recruitment and retention of women for clinical leiomyoma trials - Corrected ProofDesireé McCarthy-Keith, Sahadat Nurudeen, Alicia Armstrong, Eric Levens, Lynnette K. Nieman10.1016/j.cct.2009.09.007Contemporary Clinical Trials (2009)2009-10-12Contemporary Clinical Trials2009-10-12http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001499/abstract?rss=yesAbstract: In clinical trials of systemic therapy for advanced hepatocellular carcinoma (HCC), Asian trials almost always reported poorer survival than non-Asian trials. 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 included non-Asian trials (p=0.0007), higher percentage of Child A cirrhosis (p=0.01) and hepatitis B (HBV)-related HCC (p=0.02). Sub-group analysis suggested that Asian trials tended to enroll patients with more advanced diseases. Independent predictors of better treatment effect included non-Asian trials, higher percentage of extra-hepatic metastasis, HBV-related HCC, and poorer trial quality. The quantitative estimation of the geographic difference can help design of future clinical trials of advanced HCC.Geographic difference in survival outcome for advanced hepatocellular carcinoma: Implications on future clinical trial design - Corrected ProofChiun Hsu, Ying-Chun Shen, Chia-Chi Cheng, Fu-Chang Hu, Ann-Lii Cheng10.1016/j.cct.2009.08.002Contemporary Clinical Trials (2009)2009-10-05Contemporary Clinical Trials2009-10-05http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001505/abstract?rss=yesAbstract: 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 placebo. An improvement in ALT is defined as reduction in serum ALT levels to below 50% of the baseline values or into the normal range (40U/L or less) during the last 48weeks of treatment. Histological improvement is defined by changes in liver histology between a baseline and end-of-treatment liver biopsy in regards to (1) steatohepatitis, (2) NAFLD Activity Score, consisting of scores for steatosis, lobular inflammation, and hepatocellular injury (ballooning), and (3) fibrosis score.Methods: Between September 2005 and September 2007, 173 children were enrolled into TONIC at 10 clinical centers in the United States. Participants were randomized to receive either metformin (500mg b.i.d.), vitamin E (400IU b.i.d.), or placebo for 96weeks. This protocol was approved by all participating center Institutional Review Boards (IRBs) and an independent Data and Safety Monitoring Board (DSMB). (ClinicalTrials.gov number, NCT00063635.)Treatment of nonalcoholic fatty liver disease in children: TONIC trial design - Corrected ProofJoel E. Lavine, Jeffrey B. Schwimmer, Jean P. Molleston, Ann O. Scheimann, Karen F. Murray, Stephanie H. Abrams, Philip Rosenthal, Arun J. Sanyal, Patricia R. Robuck, Elizabeth M. Brunt, Aynur Ünalp, James Tonascia, The NASH CRN Research Group10.1016/j.cct.2009.09.001Contemporary Clinical Trials (2009)2009-10-05Contemporary Clinical Trials2009-10-05http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001517/abstract?rss=yesAbstract: 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 achieved through increases in physical activity (180min/wk) and decreases in caloric intake (approximately 1500kcal/day). The intervention consists of CHW-led group-mediated cognitive behavioral meetings that occur weekly for 6months and monthly thereafter for 18months. UC consists of 2 individual meetings with a registered dietitian and a monthly newsletter. The primary outcome is change in fasting blood glucose. Secondary outcomes include cardiovascular risk factors, health-related quality of life, and social cognitive variables. Outcomes are masked and are collected every 6months. The cost-effectiveness of the program will also be assessed. A community-based program that is administered through local DCC's and that harnesses the experience of community members (CHW's) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals.Healthy Living Partnerships to Prevent Diabetes (HELP PD): Design and methods - Corrected ProofJeffrey A. Katula, Mara Z. Vitolins, Erica L. Rosenberger, Caroline Blackwell, Mark A. Espeland, Michael S. Lawlor, W. Jack Rejeski, David C. Goff10.1016/j.cct.2009.09.002Contemporary Clinical Trials (2009)2009-10-05Contemporary Clinical Trials2009-10-05http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001529/abstract?rss=yesAbstract: Background: If a patient agrees to take part in a randomised trial it is reasonable to presume that the patient would prefer to be allocated into the intervention. This study's aim was to investigate how patients react after they have been randomised into control group.Methods: Nested study within two randomised trials. Telephone interviews with a structured questionnaire. The participants were invited after they had been randomised into the control group in two smoking cessation trials. The main outcome measures were reaction to control group allocation and drop-out rates.Results: Twenty-seven out of 30 possible interviews were successfully completed. Fourteen persons expressed that they were disappointed of being allocated to the control group. Five persons said that they had not understood the consent information and three of these were very disappointed. Surprisingly these three persons said that they had not expected a randomization. A woman expressed that she “felt as if I was being swindled”. There were in total 9/117 (7.7%) lost to follow-up in the control group and there were 4/105 (3.8%) losses to follow-up in the intervention group (P=0.26). Active withdrawal of consent was slightly higher among the control group, five in the control group (4.3%) and no active withdrawals in the intervention group (P=0.06).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.Disappointment and drop-out rate after being allocated to control group in a smoking cessation trial - Corrected ProofD. Lindström, I. Sundberg-Petersson, J. Adami, H. Tönnesen10.1016/j.cct.2009.09.003Contemporary Clinical Trials (2009)2009-10-05Contemporary Clinical Trials2009-10-05http://www.journals.elsevierhealth.com/periodicals/concli/article/PIIS1551714409001487/abstract?rss=yesAbstract: Background: Many studies on the health effects of the glycemic index (GI) are confounded by differences in the intakes of other macronutrients and fibre. Little data exist about the within- and between-subject variability of the GI.Objective: Our objectives were therefore (i) to calculate the GI of eight commonly used food products with similar macronutrient and fibre composition, but with different sources of carbohydrates, (ii) to examine the inter- and intra-individual variability of the incremental area under the curve (iAUC) after consuming the reference solution, and (iii) to compare the effect of three different methods on 2-h postprandial blood glucose responses.Design: Four groups of 10 healthy subjects consumed in random order the increased (iGI) and decreased GI (dGI) variants and twice a glucose solution. All products consisted of 25g available carbohydrates (CHO). For the fruit drink, glucose values were simultaneously analyzed using venous and capillary blood samples, and by using a continuous glucose monitoring system (CGMS).Results: The GIs for increased and decreased variants were (mean±standard error of the mean (SEM)) 69±15 and 40±4 for bread, 86±14 and 48±8 for a fruit drink, 51±12 and 20±4 for cake, and 63±17 and 37±10 for a cookie. The inter- and intra-individual coefficient of variation (CV) of the iAUCs of the reference solution was large and varied respectively between 13 and 38%, and between 33 and 80%.Conclusions: These data suggest that the GI is difficult to use at the individual level.Variability of the glycemic response to single food products in healthy subjects - Corrected ProofRuth Vrolix, Ronald P. Mensink10.1016/j.cct.2009.08.001Contemporary Clinical Trials (2009)2009-09-22Contemporary Clinical Trials2009-09-22