Article type
Year
Abstract
Background: Diagnostic tests represent a pivotal part of patient management. Often clinicians adopt tests for clinical use on the basis of findings of diagnostic accuracy. Although in some instances simply knowing accuracy can allow inferences of patient benefit, in many others the use even of accurate tests may not improve outcomes important to patients. The latter situations require randomized trials of alternative diagnostic strategies to establish benefit.
Objectives: To provide a perspective on the current practice of randomized trials of diagnostic strategies, focusing on outcomes important to patients.
Methods: We included randomized controlled trials (RCTs) published in full-text reports that evaluated alternative diagnostic strategies.
Results: We included 130 eligible RCTs from 56,912 unique citations. These trials reported on: morbidities (n = 102; 78.5%); mortality (n = 53; 40.8%); and on symptoms/quality of life/functional status (n = 50; 38.5%). The number and percentage of the RCTs classified as low risk of bias were: generation of allocation (n = 66; 50.7%); allocation concealment (n = 44; 33.8%); blinding (n = 28; 21.5%); missing outcome data (n = 74; 56.9%); selective reporting (n = 44; 33.8%) and; free of other problems (n = 37; 28.4%). Of the 130 RCTs, 44 evaluated mortality; two reported statistically significant results, but neither provided an estimate of relative effect; 28 did not report whether the results were statistically significant and 14 of them reported a non-statistically significant results. Investigators reported the impact of morbidity in 75 RCTs: 16 reported statistically significant results, two of which reported a risk ratio (RR) less than 0.8 and two reported a RR greater than 1.0 – the remaining 14 did not report RRs; 32 did not report whether the results were statistically significant and 27 reported a non-statistically significant results.
Conclusions: Randomized trials of diagnostic tests are not rare, seldom show clear benefits on patient-important outcomes, and often suffer from limitations in reporting and conduct.
Objectives: To provide a perspective on the current practice of randomized trials of diagnostic strategies, focusing on outcomes important to patients.
Methods: We included randomized controlled trials (RCTs) published in full-text reports that evaluated alternative diagnostic strategies.
Results: We included 130 eligible RCTs from 56,912 unique citations. These trials reported on: morbidities (n = 102; 78.5%); mortality (n = 53; 40.8%); and on symptoms/quality of life/functional status (n = 50; 38.5%). The number and percentage of the RCTs classified as low risk of bias were: generation of allocation (n = 66; 50.7%); allocation concealment (n = 44; 33.8%); blinding (n = 28; 21.5%); missing outcome data (n = 74; 56.9%); selective reporting (n = 44; 33.8%) and; free of other problems (n = 37; 28.4%). Of the 130 RCTs, 44 evaluated mortality; two reported statistically significant results, but neither provided an estimate of relative effect; 28 did not report whether the results were statistically significant and 14 of them reported a non-statistically significant results. Investigators reported the impact of morbidity in 75 RCTs: 16 reported statistically significant results, two of which reported a risk ratio (RR) less than 0.8 and two reported a RR greater than 1.0 – the remaining 14 did not report RRs; 32 did not report whether the results were statistically significant and 27 reported a non-statistically significant results.
Conclusions: Randomized trials of diagnostic tests are not rare, seldom show clear benefits on patient-important outcomes, and often suffer from limitations in reporting and conduct.