کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
7519547 | 1486837 | 2017 | 25 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Series: Pragmatic trials and real world evidence: Paper 3. Patient selection challenges and consequences
ترجمه فارسی عنوان
سری: مطالعات عملی و شواهد واقعی جهان: مقاله 3. چالش ها و پیامدهای انتخاب بیمار
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
پزشکی و دندانپزشکی
سیاست های بهداشت و سلامت عمومی
چکیده انگلیسی
This paper addresses challenges of identifying, enrolling, and retaining participants in a trial conducted within a routine care setting. All patients who are potential candidates for the treatments in routine clinical practice should be considered eligible for a pragmatic trial. To ensure generalizability, the recruited sample should have a similar distribution of the treatment effect modifiers as the target population. In practice, this can be best achieved by including-within the selected sites-all patients without further selection. If relevant heterogeneity between subgroups is expected, increasing the relative proportion of the subgroup of patients in the heterogeneous trial could be considered (oversampling) or a separate trial in this subgroup can be planned. Selection will nevertheless occur. Low enrollment and loss to follow-up can introduce selection and can jeopardize validity as well as generalizability. Pragmatic trials are conducted in clinical practice rather than in a dedicated research setting, which could reduce recruitment rates. However, if a trial poses a minimal burden to the physician and the patient and routine clinical practice is maximally adhered to, the participation rate may be high and loss to follow-up will not be a specific problem for pragmatic trials.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Clinical Epidemiology - Volume 89, September 2017, Pages 173-180
Journal: Journal of Clinical Epidemiology - Volume 89, September 2017, Pages 173-180
نویسندگان
Katrien Oude Rengerink, Shona Kalkman, Susan Collier, Antonio Ciaglia, Sally D. Worsley, Alison Lightbourne, Laurent Eckert, Rolf H.H. Groenwold, Diederick E. Grobbee, Elaine A. Irving,