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Clinical Trials: Journal of the Society for Clinical Trials

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https://read.qxmd.com/read/30782014/caregiver-guided-pain-coping-skills-training-for-patients-with-advanced-cancer-background-design-and-challenges-for-the-caringpals-study
#1
Laura S Porter, Gregory Samsa, Jennifer L Steel, Laura C Hanson, Thomas W LeBlanc, Janet Bull, Stacy Fischer, Francis J Keefe
BACKGROUND/AIMS: Pain is a major concern of patients with advanced cancer and their caregivers. There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference. However, few such interventions have been tested for patients with advanced cancer and their family caregivers. This study aims to test the efficacy of a caregiver-guided pain coping skills training protocol on patient and caregiver outcomes...
February 19, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30782001/exploring-the-roots-of-clinical-trial-methodology-in-medieval-islamic-medicine
#2
Mahdi Zarvandi, Ramin Sadeghi
There is a dominant opinion in the Western sources of history of medicine that the roots of modern clinical trials and methodology of experimental medicine first started in the Renaissance. However, this opinion has been disputed with the thorough study of the rich medical literature of the medieval Islamic era. In the current review, the roots of clinical trial methodology have been traced back to the medieval Islamic tradition and the contribution of Islamic scholars in this field is discussed. The importance of experimental versus theoretical reasoning, the need for a control group, a statistical approach to interpreting trial results, appreciation of uncertainty in medical practice, and the difference between human and animal trials all can be traced back to the rich medieval Islamic medical literature...
February 19, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30764659/a-review-of-the-impact-of-utilising-electronic-medical-records-for-clinical-research-recruitment
#3
Yan See Lai, Janyne Dawn Afseth
INTRODUCTION: Recruitment is an important aspect of clinical research, as poor recruitment could undermine the scientific value of a trial or delay the development process of new treatments. The development of electronic medical records provides a new way to identify potential participants for trials by matching the eligibility criteria with patients' data within electronic medical records. METHODS: A literature search was performed to examine the effectiveness and efficiency of the electronic medical record recruitment method using MEDLINE, PubMed, PubMed Central, CINAHL Plus with Full Text, ScienceDirect and Cochrane Library databases...
February 15, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30764658/defining-treatment-effects-a-regulatory-perspective
#4
Thomas Permutt
The proposed addendum to the International Conference on Harmonization document, Statistical Principles for Clinical Trials, can be read in two ways. There is a new framework for talking about estimands, but is it about fitting present methods into the framework? Or is it about changing methods? My answer: some of each. Where different methods are needed, there are challenging problems in estimating some desirable estimands, but there may also be desirable estimands that can be estimated easily and robustly...
February 14, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30761907/merged-block-randomisation-a-novel-randomisation-procedure-for-small-clinical-trials
#5
Stéphanie L van der Pas
BACKGROUND/AIMS: Randomisation in small clinical trials is a delicate matter, due to the tension between the conflicting aims of balanced groups and unpredictable allocations. The commonly used method of permuted block randomisation has been heavily criticised for its high predictability. This article introduces merged block randomisation, a novel and conceptually simple restricted randomisation design for small clinical trials (less than 100 patients per stratum). Merged block randomisation is a simple procedure that can be carried out without need for a computer...
February 14, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30760066/inference-on-covariate-effect-types-for-treatment-effectiveness-in-a-randomized-trial-with-a-binary-outcome
#6
Yasutaka Chiba
BACKGROUND/AIMS: Some randomized clinical trials seek to establish covariate effect types that indicate whether a covariate is predictive and/or prognostic, in addition to endpoint evaluation. Here, for a case with a binary outcome, we propose that the covariate effect type should be assessed in terms of four types of potential responses: activated- (always-), inert- (never-), causative-, and preventive-responder. METHODS: We introduce a new concept of covariate effect types differing from the commonly used "prediction" and "prognosis...
February 13, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30720339/the-design-and-conduct-of-project-redde-a-cluster-randomized-trial-to-reduce-diagnostic-errors-in-pediatric-primary-care
#7
David G Bundy, Hardeep Singh, Ruth Ek Stein, Tammy M Brady, Christoph U Lehmann, Moonseong Heo, Heather C O'Donnell, Elizabeth Rice-Conboy, Michael L Rinke
BACKGROUND: Diagnostic errors contribute to the large burden of healthcare-associated harm experienced by children. Primary care settings involve high diagnostic uncertainty and limited time and information, creating ideal conditions for diagnostic errors. We report on the design and conduct of Project RedDE, a stepped-wedge, cluster-randomized controlled trial of a virtual quality improvement collaborative aimed at reducing diagnostic errors in pediatric primary care. METHODS: Project RedDE cluster-randomized pediatric primary care practices into one of three groups...
February 5, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30714394/investigational-drug-labeling-variability
#8
Amélie Duhamel, Maxime Thibault, Denis Lebel, Jean-François Bussières, Cynthia Tanguay
BACKGROUND/AIMS: In comparison with commercial drugs, there are few regulations concerning the labeling of investigational drugs. This leads to variability in their content and layout. This increases the risk of errors during storage, validation, compounding, dispensing and administration. The aim of this study was to evaluate the conformity and variability of investigational drug labels. Additional exploratory aims were to evaluate the use of an automated script to describe the labels and to identify the factors associated with the ease of finding a kit number...
February 3, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30688523/challenges-and-solutions-in-the-design-and-execution-of-the-prospect-phase-ii-iii-neoadjuvant-rectal-cancer-trial-ncctg-n1048-alliance
#9
Deborah Schrag, Martin Weiser, Leonard Saltz, Harvey Mamon, Marc Gollub, Ethan Basch, Alan Venook, Qian Shi
BACKGROUND: More than half of the 40,000 incident rectal cancer patients in the United States each year are diagnosed at clinical stage II and III (locally advanced stage). For this group, high rates of cure can be achieved with the combination of pelvic radiation and sensitizing 5-fluorouracil (chemoradiation), surgery and chemotherapy, but treatment is long, arduous and toxicities are substantial. The PROSPECT trial (N1048, NCT01515787) was designed to determine whether neoadjuvant chemotherapy with 5-fluorouracil and oxaliplatin (FOLFOX) could be used as an alternative to neoadjuvant chemoradiation without compromising treatment outcomes and to spare these patients excess toxicity...
January 28, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30652946/corrigendum
#10
(no author information available yet)
No abstract text is available yet for this article.
January 17, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30648428/assessing-the-impact-of-efficacy-stopping-rules-on-the-error-rates-under-the-multi-arm-multi-stage-framework
#11
Alexandra Blenkinsop, Mahesh Kb Parmar, Babak Choodari-Oskooei
BACKGROUND: The multi-arm multi-stage framework uses intermediate outcomes to assess lack-of-benefit of research arms at interim stages in randomised trials with time-to-event outcomes. However, the design lacks formal methods to evaluate early evidence of overwhelming efficacy on the definitive outcome measure. We explore the operating characteristics of this extension to the multi-arm multi-stage design and how to control the pairwise and familywise type I error rate. Using real examples and the updated nstage program, we demonstrate how such a design can be developed in practice...
January 16, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30628466/conducting-clinical-trials-costs-impacts-and-the-value-of-clinical-trials-networks-a-scoping-review
#12
Colene Bentley, Sonya Cressman, Kim van der Hoek, Karen Arts, Janet Dancey, Stuart Peacock
BACKGROUND: A significant barrier to conducting clinical trials is their high cost, which is driven primarily by the time and resources required to activate trials and reach accrual targets. The high cost of running trials has a substantial impact on their long-term feasibility and the type of clinical research undertaken. METHODS: A scoping review of the empirical literature on the costs associated with conducting clinical trials was undertaken for the years 2001-2015...
January 10, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30628459/editorial-we-may-need-large-trials-to-find-treatments-for-neurodegenerative-diseases
#13
David Alan Schoenfeld, Michael Benatar
No abstract text is available yet for this article.
January 10, 2019: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30567460/making-the-case-for-completion-bonuses-in-clinical-trials
#14
Emily A Largent, Holly Fernandez Lynch
Attrition is a serious problem in many clinical trials. The practice of offering completion bonuses-financial incentives offered to participants on the condition that they remain in a trial until they reach a prespecified study endpoint-is one means of addressing attrition. Despite their practical appeal, however, completion bonuses remain ethically controversial due to concern that they will coerce or unduly influence participants to not exercise their right to withdraw from a trial. Although this interaction with the right to withdraw does render completion bonuses conceptually distinct from other incentive payments offered to research participants, we argue here that completion bonuses are never coercive and, in the context of effective institutional review board oversight, are unlikely to be unduly influential...
December 20, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30563372/response-to-chappell
#15
Andrew J Vickers
No abstract text is available yet for this article.
December 19, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30526008/variance-prior-specification-for-a-basket-trial-design-using-bayesian-hierarchical-modeling
#16
Kristen M Cunanan, Alexia Iasonos, Ronglai Shen, Mithat Gönen
BACKGROUND: In the era of targeted therapies, clinical trials in oncology are rapidly evolving, wherein patients from multiple diseases are now enrolled and treated according to their genomic mutation(s). In such trials, known as basket trials, the different disease cohorts form the different baskets for inference. Several approaches have been proposed in the literature to efficiently use information from all baskets while simultaneously screening to find individual baskets where the drug works...
December 7, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30295050/developing-informed-consent-materials-for-non-english-speaking-participants-an-analysis-of-four-professional-firm-translations-from-english-to-spanish
#17
Kathleen Marie Brelsford, Ernesto Ruiz, Laura Beskow
BACKGROUND/AIMS: An increasing body of research is being conducted with non-English-speaking subjects. Study-related materials, including those essential for obtaining informed consent, must often be translated from English into other languages. In this study, we sought to examine the types of issues that may arise when consent materials are translated from English to Spanish. METHODS: Drawing on expertise from five individuals associated with our research team, four of whom are native Spanish speakers of different dialects of Spanish, we crafted translations of our own consent materials for biobanking using a rigorous, multi-step process involving both forward and back translation...
December 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30280910/what-gives-them-the-right-legal-privilege-and-waivers-of-consent-for-research
#18
Francis X Baker, Jon F Merz
Waivers of informed consent for research participation are permitted in the United States under the Common Rule, the Health Insurance Portability and Accountability Act regulations, and the US Food and Drug Administration's Exception from Informed Consent rule for emergency research. We assess the novel question regarding what legal right researchers have to carry out research procedures on or about another person, be it experimental medical intervention, psychological or social manipulation, or invasion of privacy, without the permission of their subjects...
December 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30280582/understanding-preferences-regarding-consent-for-pragmatic-trials-in-acute-care
#19
Neal W Dickert, David Wendler, Chandan M Devireddy, Sara F Goldkind, Yi-An Ko, Candace D Speight, Scott Yh Kim
BACKGROUND: There has been debate about the role of consent in pragmatic trials comparing qualitatively similar interventions. Consent preferences may differ in acute care contexts, given severe illness, time constraints, and other barriers to consent. In addition, studies have not assessed the impact of disclosing financial considerations as a justification for trials. This study was designed to assess preferences of the general public regarding consent for a pragmatic trial in ST-elevation myocardial infarction...
December 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://read.qxmd.com/read/30156433/contingency-management-intervention-targeting-co-addiction-of-alcohol-and-drugs-among-american-indian-adults-design-methodology-and-baseline-data
#20
Ekaterina Burduli, Jordan Skalisky, Katherine Hirchak, Michael F Orr, Albert Foote, Alexandria Granbois, Richard Ries, John M Roll, Dedra Buchwald, Michael G McDonell, Sterling M McPherson
BACKGROUND/AIMS: American Indian adults have some of the highest alcohol abstinence rates compared to the overall US population. Despite this, many American Indian people are more likely to concurrently use alcohol and illicit drugs and are less likely to participate and remain in outpatient treatment for alcohol and other drug use compared to the general US population. There is limited knowledge about effective interventions targeting alcohol and drug co-addiction among American Indian adults...
December 2018: Clinical Trials: Journal of the Society for Clinical Trials
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