Original articleCan there be a more patient-centred approach to determining clinically important effect sizes for randomized treatment trials?
References (33)
- et al.
Indexes and boundaries for “quantitative significance” in statistical decisions
J Clin Epidemiol
(1990) Using economic analysis to determine the resource consequences of choices made in planning clinical trials
J Chron Dis
(1985)- et al.
Patients' willingness to enter clinical trials: measuring the association with perceived benefit and preference for decision participation
Soc Sci Med
(1991) - et al.
The utility of different health states as perceived by the general public
J Chron Dis
(1978) - et al.
Eliciting preferences for alternative drug therapies in oncology: Influence of treatment outcome descrip tion, elicitation technique, and treatment experience on preference
J Chron Dis
(1987) Effects of framing and level of probability on patients' preferences for cancer chemotherapy
J Clin Epidemiol
(1989)- et al.
Absolutely relative: how research results are summarized can affect treatment decisions
Am J Med
(1992) Clinical Trials. Design, Conduct, Analysis
(1986)- et al.
The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial
N Engl J Med
(1978) - et al.
When was a “negative” clinical trial big enough? How many patients you needed depends on what you found
Arch Intern Med
(1985)
Clinical Epidemiology: a Basic Science for Clinical Medicine
Why do we need some large, simple randomized trials?
Stat Med
Establishing therapeutic equivalency. What is a clinically significant difference?
Arch Intern Med
Patients versus surrogates: whose opinion counts on ethics review panels?
Clin Res
The framing of decisions and the psychology of choice
Science
GISSI-2: a factorial randomised trial of alteplase versus strepokinase and heparin versus no heparin among 12,490 patients with acute myocardial infarction
Lancet
Cited by (65)
A critical review of methods used to determine the smallest worthwhile effect of interventions for low back pain
2012, Journal of Clinical EpidemiologyCitation Excerpt :Alternatively, the trial could be designed to detect effects that are at least as large as the median, or the 20th percentile, or the 80th percentile of the smallest worthwhile effect. Naylor and Llewellyn-Thomas [62] have suggested that it would be prudent to use the effect considered to be worthwhile by just 25% of participants. Similar considerations apply when data on the smallest worthwhile effect are used to make decisions about the clinical importance of an effect reported in a clinical trial.
Minimal change is sensitive, less specific to recovery: A diagnostic testing approach to interpretability
2011, Journal of Clinical EpidemiologyCitation Excerpt :Each will be described briefly. The most common approach to interpreting serial measures of health is the discernment of the minimal clinically important change/difference (MCID); approaches that estimate the much sought after threshold for a minimal amount of change; in a patient-reported outcome score, which indicates that a patient is better (or worse) [6–14]. The McMaster group led the early work in this area balancing this small but important change against the absence of excessive costs and risks [10,11] .
Patient-reported outcome instrument selection: Designing a measurement strategy
2007, Value in HealthEstimating sample size in critical care clinical trials
2005, Journal of Critical CarePreference assessment of recruitment into a randomized trial for adolescent idiopathic scoliosis
2008, Journal of Bone and Joint SurgeryCitation Excerpt :One could argue that the preferences and participation decisions from the surrogate group should not be used to predict the responses of patients approached during actual trial recruitment. Many previous simulations of recruitment for a randomized controlled trial have used surrogates in the place of patients with the actual condition under study40–43,45,72. There are two main reasons for the use of surrogates in place of actual patients.