Physicians declining patient enrollment in clinical trials: what are the implications?

Backer, Daniel De; Schortgen, Frédérique

doi:10.1007/s00134-013-3151-1

Cited by 8 publications

(5 citation statements)

References 13 publications

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“…Moribund patients are less likely to be transferred to a tertiary referral center. Also, physicians are hesitant to include moribund patients in clinical studies (demonstrated by the low mortality in patients identified by the treating physician), whereas 30% of deaths occurred within the first 3 days [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

Pneumococcal Meningitis in Adults: A Prospective Nationwide Cohort Study Over a 20-year Period

Koelman

Brouwer

Horst

et al. 2021

Clinical Infectious Diseases

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Background The epidemiology and treatment of pneumococcal meningitis has changed with the implementation of conjugate vaccines and the introduction of adjunctive dexamethasone therapy. Methods We analysed episodes of community-acquired pneumococcal meningitis in adults (≥16 years) in the Netherlands, identified by the National Reference Laboratory for Bacterial Meningitis or treating physician between Oct 1, 1998 and Apr 1, 2002 and between Jan 1, 2006 and July 1, 2018. We studied incidence, pneumococcal serotypes and clinical features. Predictors for unfavourable outcome (Glasgow Outcome Scale score 1-4) were identified in a multivariable logistic regression model. Two physicians independently categorized causes of death as neurological or systemic. Results There were 1816 episodes in 1783 patients. The incidence of 7- and 10-7-valent pneumococcal conjugate vaccine serotypes decreased (0.42 to 0.06, p=0.001 and 0.12 to 0.03 episodes per 100,000 population per year, p=0.014). Incidence of non-vaccine serotypes increased (0.45 to 0.68, p=0.005). The use of adjunctive treatment with dexamethasone increased and was administered in 85% of patients in 2018. In-hospital death occurred in 363 episodes (20%) and unfavourable outcome in 772 episodes (43%). Delayed cerebral thrombosis occurred in 29 patients (2%) of whom 15 patients (52%) died. Adjunctive dexamethasone therapy was associated with favourable outcome (adjusted odds ratio 2.27, p<0.001), individual pneumococcal serotypes were not. Conclusion Implementation of conjugate vaccines and adjunctive dexamethasone therapy have changed the incidence and outcome of pneumococcal meningitis in adults over the last two decades. Despite recent advances pneumococcal meningitis remains associated with a residual high rate of mortality and morbidity.

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Section: Discussionmentioning

confidence: 99%

Pneumococcal Meningitis in Adults: A Prospective Nationwide Cohort Study Over a 20-year Period

Koelman

Brouwer

Horst

et al. 2021

Clinical Infectious Diseases

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“…Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine and the foundation of daily clinical practice. 1 Ideally, clinical trial populations should represent the population of interest to gain broadly applicable results. Sample populations, however, are often restrictive and may reflect only a minority of individuals treated in daily practice, limiting the applicability of evidence obtained from clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Applicability of Vasopressor Trials in Adult Critical Care: A Prospective Multicentre Meta-Epidemiologic Cohort Study

Buchtele¹,

Schwameis²,

Roth³

et al. 2022

CLEP

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Objective To assess the applicability of evidence from landmark randomized controlled trials (RCTs) of vasopressor treatment in critically ill adults. Study Design and Setting This prospective, multi-center cohort study was conducted at five medical and surgical intensive care units at three tertiary care centers. Consecutive cases of newly initiated vasopressor treatment were included. The primary end point was the proportion of patients (≥18 years) who met the eligibility criteria of 25 RCTs of vasopressor therapy in critically ill adults included in the most recent Cochrane review. Multilevel Poisson regression was used to estimate the eligibility proportions with 95% confidence intervals for each trial. Secondary end points included the eligibility criteria that contributed most to trial ineligibility, and the relationship between eligibility proportions and (i) the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) score, and (ii) the recruitment-to-screening ratio of each RCT. The PRECIS-2 score was used to assess the degree of pragmatism of each trial. Results Between January 1, 2017, and January 1, 2019, a total of 1189 cases of newly initiated vasopressor therapy were included. The median proportion of cases meeting eligibility criteria for all 25 RCTs ranged from 1.3% to 6.0%. The eligibility criteria contributing most to trial ineligibility were the exceedance of a specific norepinephrine dose, the presence of a particular shock type, and the drop below a particular blood pressure value. Eligibility proportions increased with the PRECIS-2 score but not with the recruitment-to-screening ratio of the trials. Conclusion The applicability of evidence from available trials on vasopressor treatment in critically ill adults to patients receiving vasopressors in daily practice is limited. Applicability increases with the degree of study pragmatism but is not reflected in a high recruitment-to-screening ratio. Our findings may help researchers design vasopressor trials and promote standardized assessment and reporting of the degree of pragmatism achieved.

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“…12 A review of a small sample of trials conducted in Canada, Germany and Switzerland showed that trials in critical care and emergency medicine have higher rates of early cessation and lower recruitment speeds compared to trials in other medical disciplines. 13 Not all eligible patients at participating sites are randomised into RCTs [14][15][16] and recruitment rates can be highly variable. 17 Projected recruitment rates are often higher than actual recruitment rates.…”

Section: Introductionmentioning

confidence: 99%

Recruitment characteristics of randomised trials in critical care: A systematic review

et al. 2022

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Background/Aims: To summarise the temporal trends of recruitment and methodological characteristics of critical care randomised controlled trials with the primary outcome of mortality. Methods: PubMed was searched for articles meeting inclusion and exclusion criteria. Randomised controlled trials, with primary outcome of mortality, of adult and paediatric critical care patients treated in an intensive care unit, were included. Neonatal intensive care unit trials, non-English publications and conference proceedings or abstracts without full-length publications were excluded. Duplicate literature search, article selection and quality assessment were performed by two reviewers with disputes resolved through discussion. Data were extracted into a custom-designed Research Electronic Data Capture database. Results: The search identified 67,199 records of which 230 were included. The annual number of critical care randomised controlled trials published increased gradually over a 30-year period from 0 in 1990 to 19 in 2014 with stabilisation at 8–11 between 2015 and 2020. Twenty-seven percent of randomised controlled trials were low risk in all categories using the Cochrane Risk of Bias tool. Methodological characteristics such as registration on clinical trials registries and data safety monitoring committee presence significantly (p < 0.001) increased over time. The median recruitment was 376 patients (interquartile range 125–895) with significant increase (p = 0.002) from 62 (interquartile range: 33–486) in 1991 to 725 (interquartile range: 537–2600) in 2020. This was accompanied by an increase in recruitment times. Thus overall, recruitment rates did not increase. Early cessation occurred in 23% (54/230) of randomised controlled trials with no temporal trend. Conclusion: The number, size and some methodological qualities of critical randomised controlled trials with primary outcome of mortality have increased over time, but rates of recruitment and early cessation have been unchanged.

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Physicians declining patient enrollment in clinical trials: what are the implications?

Cited by 8 publications

References 13 publications

Pneumococcal Meningitis in Adults: A Prospective Nationwide Cohort Study Over a 20-year Period

Pneumococcal Meningitis in Adults: A Prospective Nationwide Cohort Study Over a 20-year Period

Applicability of Vasopressor Trials in Adult Critical Care: A Prospective Multicentre Meta-Epidemiologic Cohort Study

Recruitment characteristics of randomised trials in critical care: A systematic review

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