BACKGROUND Community-based randomized controlled trials are often complex pieces of research with significant challenges around the approach to the community, information provision, and decision-making, all of which are fundamental to the informed consent process. We conducted a rapid ethical assessment to guide the preparation for and conduct of a randomized controlled trial of podoconiosis tr...

BACKGROUND There is evidence to suggest that frontline community health workers in Malawi are under-referring children to higher-level facilities. Integrating a digitized version of paper-based methods of Community Case Management (CCM) could strengthen delivery, increasing urgent referral rates and preventing unnecessary re-consultations and hospital admissions. This trial aims to evaluate the...

There is a general agreement that before a therapy can be accepted into widespread clinical use, demonstration of efficacy in randomized clinical trials (RCTs) is absolutely necessary. There are, however, a growing number of experts who believe that demonstration of RCT efficacy might not be a sufficient basis for widespread acceptance.1 RCTs may not enroll subjects representative of patients i...

REFERENCES 1 Lorgelly PK, Atkinson M, Lakhanpaul M, et al. Oral versus i.v. antibiotics for community-acquired pneumonia in children: a costminimisation analysis. Eur Respir J 2010; 35: 858–864. 2 Atkinson M, Lakhanpaul M, Smyth A, et al. Comparison of oral amoxicillin and intravenous benzyl penicillin for community acquired pneumonia in children (PIVOT trial): a multicentre pragmatic randomise...

There is a general agreement that before a therapy can be accepted into widespread clinical use, demonstration of efficacy in randomized clinical trials (RCTs) is absolutely necessary. There are, however, a growing number of experts who believe that demonstration of RCT efficacy might not be a sufficient basis for widespread acceptance.1 RCTs may not enroll subjects representative of patients i...

There is a general agreement that before a therapy can be accepted into widespread clinical use, demonstration of efficacy in randomized clinical trials (RCTs) is absolutely necessary. There are, however, a growing number of experts who believe that demonstration of RCT efficacy might not be a sufficient basis for widespread acceptance.1 RCTs may not enroll subjects representative of patients i...

BACKGROUND The Affordable Care Act mandates that new insurance plans cover smoking-cessation therapy without cost-sharing. Previous cost difference estimates, which show a spike around the time of cessation, suggest premiums might rise as a result of covering these services. PURPOSE The goal of the study was to test (1) whether individuals in an RCT of pharmacotherapy and counseling for smoki...

BACKGROUND Internationally, few clinical trials have involved Deaf people who use a signed language and none have involved BSL (British Sign Language) users. Appropriate terminology in BSL for key concepts in clinical trials that are relevant to recruitment and participant information materials, to support informed consent, do not exist. Barriers to conceptual understanding of trial participati...

Although an estimated 20% of adult cancer patients are medically eligible for a cancer treatment clinical trial (CCT), adult trial participation in the U.S. remains under 3%.- Participation rates are even lower among ethnic and racial minorities and the medically underserved, who tend to have higher cancer mortality rates than the population as a whole.- Given persistent cancer health dispariti...