Run-in bias in randomised trials: the case of COPD medications

Suissa, Samy

doi:10.1183/13993003.00361-2017

Cited by 28 publications

(20 citation statements)

References 24 publications

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“…Conversely, RCTs are associated with limitations of their own, such as their limited size and duration of exposure, as well as a lack of generalisability to the general COPD population due to stringent inclusion criteria and trial setting [64]. Moreover, RCTs may introduce bias due to the deleterious effect of treatment withdrawal at randomisation, the inclusion of a run-in period, the use of untreated placebo groups and by truncating follow-up at treatment discontinuation [67][68][69].…”

Section: Pharmacological Management Of Copd and Cvdmentioning

confidence: 99%

Cardiovascular disease and COPD: dangerous liaisons?

2018

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Chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD) frequently occur together and their coexistence is associated with worse outcomes than either condition alone. Pathophysiological links between COPD and CVD include lung hyperinflation, systemic inflammation and COPD exacerbations. COPD treatments may produce beneficial cardiovascular (CV) effects, such as long-acting bronchodilators, which are associated with improvements in arterial stiffness, pulmonary vasoconstriction, and cardiac function. However, data are limited regarding whether these translate into benefits in CV outcomes. Some studies have suggested that treatment with long-acting β2-agonists and long-acting muscarinic antagonists leads to an increase in the risk of CV events, particularly at treatment initiation, although the safety profile of these agents with prolonged use appears reassuring. Some CV medications may have a beneficial impact on COPD outcomes, but there have been concerns about β-blocker use leading to bronchospasm in COPD, which may result in patients not receiving guideline-recommended treatment. However, there are few data suggesting harm with these agents and patients should not be denied β-blockers if required. Clearer recommendations are necessary regarding the identification and management of comorbid CVD in patients with COPD in order to facilitate early intervention and appropriate treatment.

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Section: Pharmacological Management Of Copd and Cvdmentioning

confidence: 99%

Cardiovascular disease and COPD: dangerous liaisons?

2018

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“…IMPACT found a lower rate of exacerbations with LABA/ICS than with LAMA/LABA (1.07 versus 1.21, respectively), opposite to that of the FLAME trial (1.19 versus 0.98). An important difference between the trials is the inclusion of patients with a past asthma diagnosis, excluded in the FLAME trial, as well as the approach to the run-in period [20,21].…”

Section: Resultsmentioning

confidence: 99%

Triple therapy trials in COPD: a precision medicine opportunity

Suissa

Ariel

2018

Eur Respir J

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“…The minimum sample size of 30 was inflated to 40 to allow for dropouts during the run-in period (15%) and dropouts following randomization (10%), which was estimated to be a total of 25% based on similar studies [34][35][36][37]. In the absence of any dropouts during the run-in period, we will randomize 40 participants (20 in each group).…”

Section: Sample Sizementioning

confidence: 99%

“…The runin period will be used to minimize dropouts after randomization by identifying participants who are likely to take up the intervention and to complete outcome assessments. It will exclude participants who are unlikely to take up activities that are like those used in the trial [34][35][36][37][38][39]. Participants who complete all three of the study's run-in requirements will be eligible for randomization.…”

Section: Run-in Periodmentioning

confidence: 99%

Microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices in economically-vulnerable African-American young adults (EMERGE): protocol for a feasibility randomized clinical trial

Mayo-Wilson

Glass

Ssewamala

et al. 2019

Trials

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Background Economic vulnerability, such as homelessness and unemployment, contributes to the HIV risk among racial minorities in the U.S., who are disproportionately infected. Yet, few economic-strengthening interventions have been adapted for HIV prevention in economically-vulnerable African-American young adults. Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) is a feasibility randomized clinical trial of an HIV prevention microenterprise intervention with integrated text messages (“nudges”) that are informed by behavioral economic principles. The trial aims to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors. Methods/design In total, 40 young adults who are African-American, aged 18–24, live in Baltimore City, have experienced at least one episode of homelessness in the last 12 months, are unemployed or underemployed (fewer than 10 h per week), are not enrolled in school, own a cell phone with text messaging, and report at least one episode of unprotected or unsafe sex in the prior 12 months will be recruited from two community-based organizations providing residential supportive services to urban youth. Participants will undergo a 3-week run-in period and thereafter be randomly assigned to one of two groups with active interventions for 20 weeks. The first group (“comparison”) will receive text messages with information on job openings. The second group (“experimental”) will receive text messages with information on job openings plus information on HIV prevention and business educational sessions, a mentored apprenticeship, and a start-up grant, and business and HIV prevention text messages based on principles from behavioral economics. The two primary outcomes relate to the feasibility of conducting a larger trial. Secondary outcomes relate to employment, sexual risk behaviors, and HIV preventive practices. All participants will be assessed using an in-person questionnaire at pre-intervention (prior to randomization) and at 3 weeks post-intervention. To obtain repeated, longitudinal measures, participants will be assessed weekly using text message surveys from pre-intervention up to 3 weeks post-intervention. Discussion This study will be one of the first U.S.-based feasibility randomized clinical trials of an HIV prevention microenterprise intervention for economically-vulnerable African-American young adults. The findings will inform whether and how to conduct a larger efficacy trial for HIV risk reduction in this population. Trial registration ClinicalTrials.gov, NCT03766165 . Registered on 4 December 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3529-7) contains supplementary material, which is available to authorized users.

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Run-in bias in randomised trials: the case of COPD medications

Abstract: @ERSpublicationsRandomised trials of COPD medications involving a "run-in" period could be biased: interpret results with caution

Cited by 28 publications

References 24 publications

Cardiovascular disease and COPD: dangerous liaisons?

Cardiovascular disease and COPD: dangerous liaisons?

Triple therapy trials in COPD: a precision medicine opportunity

Microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices in economically-vulnerable African-American young adults (EMERGE): protocol for a feasibility randomized clinical trial

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