Sensitivity analysis in clinical trials: three criteria for a valid sensitivity analysis
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When the findings from a sensitivity analysis are consistent with the primary results, confidence that the primary results are valid can be increased.
“When the findings from a sensitivity analysis are consistent with the primary results, confidence that the primary results are valid can be increased.445 447”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [447]
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Cites
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Self-citationChoosing sensitivity analyses for randomised trials: principles
Morris, T. P., Kahan, B. C., & White, I. R. (2014) · BMC Medical Research Methodology · doi:10.1186/1471-2288-14-11 · Cited by 75 · cited 1× · see citing works
“proposed a framework to conduct such analysis [2] and suggest that a particular analysis can be classified as a sensitivity analysis if it meets the following criteria: (1) the proposed analysis aims to answer the same question as to the primary analysis, (2) there is a possibility that the proposed analysis will lead…”
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CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials
Hopewell, S., Chan, A.-W., Collins, G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081124 · Cited by 205 · see citing works
Self-citationSPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
Self-citationChallenges in and Opportunities for Electronic Health Record-Based Data Analysis and Interpretation
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“44”
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“To confirm that findings were not dependent on the method adopted to classify OA as either OA-HA or OA-LA, sensitivity analyses were conducted (Parpia et al., 2022).”
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“A posteriori sensitivity analysis was performed through the assessment of the female subjects of the sample.(20) Data were analyzed using IBM SPSS v25 software.”
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“[37] The current analysis indicates that the MDs in each study are negative, and the 95% CIs do not include zero, suggesting a statistically significant difference between the ketamine group and the control group, regardless of which study was excluded.”
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“A sensitivity analysis was performed to examine whether changes in the distributional assumptions of the outcomes affected the observed associations [26–28], thereby ascertaining the reliability and robustness of the main results.”
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“When the results of a sensitivity analysis conflict with those of the primary analysis, it is recommended to thoroughly discuss the causes of the discrepancy and its implications for the primary findings [19].”
Evidence contamination: what it is and why it matters
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“44 However, this may be deemed unethical by authors whose studies are impacted, and this needs further consideration.”
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“Sensitivity analysis plays a crucial role in assessing the robustness of the findings or conclusions based on primary analyses of data derived from clinical trials [46].”
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- Authors
- Parpia, S., Morris, T. P., Phillips, M. R., Wykoff, C. C., Steel, D. H., Thabane, L., Bhandari, M., Chaudhary, V., for the Retina Evidence Trials InterNational Alliance (R.E.T.I.N.A.) Study Group, Sivaprasad, S., Kaiser, P., Sarraf, D., Bakri, S. J., Garg, S. J., Singh, R. P., Holz, F. G., Wong, T. Y., & Guymer, R. H.
- Affiliations
- McMaster University (CA)
- MRC Clinical Trials Unit at UCL (GB)
- Houston Methodist (US)
- Sunderland Eye Infirmary (GB)
- St. Joseph’s Healthcare Hamilton (CA)
- NIHR Moorfields Biomedical Research Centre (GB)
- Cleveland Clinic (US)
- Mayo Clinic (US)
- University of Bonn (DE)
- Singapore National Eye Center (SG)
- The University of Melbourne (AU)
- Corresponding author
- Chaudhary, Varun
- ORCID
- Venue
- Eye
- Published
- 2022-05-18
- Volume
- 36
- Issue
- 11
- Pages
- 2073-2074
- ISSN
- 0078-5334 (ISSN-L)
- 0950-222X
- 1476-5454
- PMC
- PMC9581998
- OpenAlex
- W4280546958
- Cited by
- 32
- References
- 2
- Citations by year
- 2026: 6 · 2025: 14 · 2024: 9 · 2023: 3
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Eye (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute for Health and Care Research (NIHR203731)
- Medical Research Council (MC_UU_00004/07)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- sensitivity analysis, randomized controlled trials, statistical analysis plan, validity criteria, methodological recommendations
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