Intention-to-treat analysis: difference between revisions
Diff·revision 13 → 14·15:08, 20 May 2025
Difference between revision 13 and revision 14 of Intention-to-treat analysis. 6 lines changed; the page grew by 815 bytes.
| Revision 13 — 20:34, 23 Apr 2025 INN_Ingrid (talk) split the results table so the two doses are separate rows 3,822 bytes ±0 | Revision 14 — 15:08, 20 May 2025 FlowTrialFraser (talk) add the year of publication to each trial in the list 4,637 bytes +815 | ||
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| 33 | Obesity trials in this field commonly use a reference-based approach for the treatment-policy estimand, which assumes that participants who stop revert towards placebo behaviour — a conservative and reasonably defensible assumption given the [[Weight regain after discontinuation|regain observed after discontinuation]].{{r|ich_e9}} | 33 | Obesity trials in this field commonly use a reference-based approach for the treatment-policy estimand, which assumes that participants who stop revert towards placebo behaviour — a conservative and reasonably defensible assumption given the [[Weight regain after discontinuation|regain observed after discontinuation]].{{r|ich_e9}} |
| 34 | 34 | ||
| + | 35 | == Estimands == | |
| + | 36 | Current guidance frames the question as choosing an ''estimand'' — a precise statement of what quantity is being estimated, including how intercurrent events such as discontinuation and rescue medication are handled.{{r|ich_e9}} | |
| + | 37 | ||
| + | 38 | Two are common in this field. The ''treatment policy'' estimand asks what happens when treatment is initiated, counting all data regardless of adherence; the ''trial product'' estimand asks what happens if treatment is taken as directed throughout. The second gives larger effects, and the two are frequently reported side by side.{{r|wilding2021}} | |
| + | 39 | ||
| 35 | == References == | 40 | == References == |
| 36 | {{reflist}} | 41 | {{reflist}} |
| 37 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> | 42 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> |
| 38 | <ref name="hollis1999">Hollis S, Campbell F. "What is meant by intention to treat analysis? Survey of published randomised controlled trials." ''BMJ'' 319(7211):670–674 (1999). PMID 10480822.</ref> | 43 | <ref name="hollis1999">Hollis S, Campbell F. "What is meant by intention to treat analysis? Survey of published randomised controlled trials." ''BMJ'' 319(7211):670–674 (1999). PMID 10480822.</ref> |
| + | 44 | <ref name="wilding2021">Wilding JPH, Batterham RL, Calanna S, et al. "Once-weekly semaglutide in adults with overweight or obesity." ''New England Journal of Medicine'' 384(11):989–1002 (2021). PMID 33567185.</ref> | |
| 39 | <ref name="ich_e10">International Council for Harmonisation, ''E10: Choice of Control Group and Related Issues in Clinical Trials'' (2000).</ref> | 45 | <ref name="ich_e10">International Council for Harmonisation, ''E10: Choice of Control Group and Related Issues in Clinical Trials'' (2000).</ref> |
| 40 | 46 |