Original articleCost-effectiveness comparisons using “real world” randomized trials: The case of new antidepressant drugs
References (43)
- et al.
Explanatory and pragmatic attitudes in clinical trials
J Chronic Dis
(1967) Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs
Preventive Med
(1986)- et al.
Strategies for evaluating treatments for major depression in primary care patients
Gen Hosp Psychiat
(1991) - et al.
Patterns of antidepressant use in community practice
Gen Hosp Psychiat
(1993) - et al.
Treating depression in primary care practice: an application of decision analysis
Gen Hosp Psychiat
(1989) - et al.
Telephone assessment of depression severity
J Psychiatr Res
(1993) - et al.
Controversy in counting and attributing events in clinical trials
NEJM
(1979) An additional basic science for clinical medicine: II. The limitations of randomized trials
Ann Intern Med
(1983)- et al.
- et al.
Alternative perspectives on the biased foundations of medical technology assessment
Ann Intern Med
(1993)
Cost effectiveness as a criterion for Medicare coverage
NEJM
Outcomes research, cost containment, and the fear of health care rationing
NEJM
Variations in the use of medical and surgical services by the medicare population
NEJM
Which rate is right?
NEJM
Outcomes research—a way to improve medical practice. From the Agency of Health Care Policy and Research
JAMA
Decision analysis: a progress report
Ann Intern Med
Referral bias in diabetes research
Diabetes Care
Depression in general practice: clinical features and comparison with outpatients
Br J Psychiat
Recognition, management, and course of anxiety and depression in general practice
Arch Gen Psychiat
Six-month outcomes for medical patients with major depressive disorders
J Gen Int Med
Depressive disorders in primary care
Br J Psychiat
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Series: Pragmatic trials and real world evidence: Paper 8. Data collection and management
2017, Journal of Clinical EpidemiologyCitation Excerpt :This information is usually entered in a structured, coded format, but it may not be very detailed. Consequently, claims databases often lack information on relevant clinical variables and patient characteristics, and often the information will not be timely [12–14]. There is a trend though among database owners of claims data, especially in the United States, to increase the number of clinical variables to make the databases usable for scientific research purposes (eg, Optum) [15].
The "efficacy-effectiveness gap": Historical background and current conceptualization
2016, Value in HealthCitation Excerpt :The concept of pragmatism holds that this lack of generalizability has led to an EEG and that any direct dissemination of evidence arising from clinical trials into clinical practice might be inadequate [52,53]. In line with this concept, the generation of real-life evidence on the impact of drugs is becoming increasingly recommended, namely, for pharmaceutical companies [10,51,54], in which such evidence is seen as complementary [55–57]. More recently, a third paradigm has been developed in which any quantitative difference in drugs effect estimates, as measured in an experimental setting or in routine practice, may be understood as the result of interaction of multiple real-life characteristics on the purely biological effect of the drug.
A scale for distinguishing efficacy from effectiveness was adapted and applied to stroke rehabilitation studies
2010, Journal of Clinical EpidemiologyHealth economics of osteoporosis
2008, Best Practice and Research: Clinical Endocrinology and MetabolismCitation Excerpt :Whereas randomized controlled trials (RCTs) remain the gold standard for comparing alternative treatments, the high internal validity required to demonstrate efficacy comes at the expense of external validity. The results of such trials may therefore generalize poorly to clinical practice.19,20 For example, adherence as observed in clinical trials is likely to be higher than in clinical practice, which in the context of the health economic analysis would yield lower benefits of therapy and potentially overestimated cost-effectiveness when using clinical trial data on adherence and efficacy.
When Can We Rely on Real-World Evidence to Evaluate New Medical Treatments?
2022, Clinical Pharmacology and Therapeutics