The Missing Voice of Patients in Drug-Safety Reporting
Open accessAbstract
A patient wants to know about symptoms she may have from a prescription drug she is taking.Consulting the label's "Adverse Reactions" section, she finds a wealth of data.Little does she realize thatThe New England
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Many clinical hepatology studies are based on clinician-reported adverse events or improvements, which do not correlate well with patient-reported harms or improvements.
“Many clinical hepatology studies are based on clinician-reported adverse events or improvements, which do not correlate well with patient-reported harms or improvements [14, 15].”
From Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C (2018) · cites this paper as [14]
In “The Missing Patient Voice in Drug-Safety Reporting” (page not specified), Basch says clinical-trial adverse-symptom data rely largely on clinicians’ impressions and that clinicians downgrade or miss symptoms patients report. This supports the point about discrepancies in reported harms, but the paper does not establish the claim specifically for hepatology studies or address agreement about reported improvements. (LLM, conf=0.86)
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Cites
Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement
Ioannidis, J. P. A., Evans, S. J. W., Gøtzsche, P. C., O'Neill, R. T., Altman, D. G., Schulz, K., Moher, D., & for the CONSORT Group* (2004) · Annals of Internal Medicine · doi:10.7326/0003-4819-141-10-200411160-00009 · Cited by 1,593 · see citing works
Adverse Symptom Event Reporting by Patients vs Clinicians: Relationships With Clinical Outcomes
Basch, E., Jia, X., Heller, G., Leahy, A. B., Sit, L., Fruscione, M., Appawu, M., Iasonos, A. E., Atkinson, T. M., Goldfarb, S. B., et al. (2009) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djp386 · Cited by 622 · see citing works
Self-citationAgreement between patient-reported symptoms and their documentation in the medical record.
Pakhomov, S., Jacobsen, S. J., Chute, C. G., & Roger, V. L. (2008) · PubMed · Cited by 273 · see citing works
Patient-Reported Medication Symptoms in Primary Care
Weingart, S. N. (2005) · Archives of Internal Medicine · doi:10.1001/archinte.165.2.234 · Cited by 143 · see citing works
Flagged first, then by citations
Research works printed but not linked: 1
- [4]Institute of Medicine, National Academy of Sciences The Future of Drug Safety: Promoting and Protecting the Health of the Public National Academies Press Washington, DC 2006
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Dueck, A. C., Mendoza, T. R., Mitchell, S. A., Reeve, B. B., Castro, K. M., Rogak, L. J., Atkinson, T. M., Bennett, A. V., Denicoff, A. M., O'Mara, A. M., et al. (2015) · JAMA Oncology · doi:10.1001/jamaoncol.2015.2639 · Cited by 1,030 · see citing works
Self-citationESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2)
Cardoso, F., Costa, A., Norton, L., Senkus, E., Aapro, M., André, F., Barrios, C. H., Bergh, J., Biganzoli, L., Blackwell, K. L., et al. (2014) · Annals of Oncology · doi:10.1093/annonc/mdu385 · Cited by 540 · see citing works
“However, there is an accumulating body of evidence suggesting that the frequency and severity of many symptoms that impact upon an individual patient's quality of life go under-reported, under-recognised and consequently under-treated [21].”
BackgroundDi Maio, M., Basch, E., Denis, F., Fallowfield, L. J., Ganz, P. A., Howell, D., Kowalski, C., Perrone, F., Stover, A. M., Sundaresan, P., et al. (2022) · Annals of Oncology · doi:10.1016/j.annonc.2022.04.007 · Cited by 509 · see citing works
Self-citationBasch, E., Abernethy, A. P., Mullins, C. D., Reeve, B. B., Smith, M. L., Coons, S. J., Sloan, J., Wenzel, K., Chauhan, C., Eppard, W., et al. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2012.42.5967 · Cited by 476 · see citing works
Self-citationChirico, A., Lucidi, F., De Laurentiis, M., Milanese, C., Napoli, A., & Giordano, A. (2016) · Journal of Cellular Physiology · doi:10.1002/jcp.25117 · Cited by 342 · see citing works
ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2)
Cardoso, F., Costa, A., Norton, L., Senkus, E., Aapro, M., André, F., Barrios, C. H., Bergh, J., Biganzoli, L., Blackwell, K. L., et al. (2014) · The Breast · doi:10.1016/j.breast.2014.08.009 · Cited by 338 · see citing works
Wagner, L. I., Schink, J., Bass, M., Patel, S., Diaz, M. V., Rothrock, N., Pearman, T., Gershon, R., Penedo, F. J., Rosen, S., et al. (2015) · Cancer · doi:10.1002/cncr.29104 · Cited by 233 · see citing works
Cannabis as a substitute for prescription drugs – a cross-sectional study
Corroon, J., Mischley, L., & Sexton, M. (2017) · Journal of Pain Research · doi:10.2147/jpr.s134330 · Cited by 208 · see citing works
Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations
Smith, S. M., Dworkin, R. H., Turk, D. C., McDermott, M. P., Eccleston, C., Farrar, J. T., Rowbotham, M. C., Bhagwagar, Z., Burke, L. B., Cowan, P., et al. (2020) · Pain · doi:10.1097/j.pain.0000000000001952 · Cited by 194 · see citing works
Madsen, M. B., Hjortrup, P. B., Hansen, M. B., Lange, T., Norrby-Teglund, A., Hyldegaard, O., & Perner, A. (2017) · Intensive Care Medicine · doi:10.1007/s00134-017-4786-0 · Cited by 128 · see citing works
Wellness within illness: Happiness in schizophrenia
Palmer, B. W., Martin, A. S., Depp, C. A., Glorioso, D. K., & Jeste, D. V. (2014) · Schizophrenia Research · doi:10.1016/j.schres.2014.07.027 · Cited by 113 · see citing works
Gastrointestinal toxicity of immune checkpoint inhibitors: From mechanisms to management
Samaan, M. A., Pavlidis, P., Papa, S., Powell, N., & Irving, P. M. (2018) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/nrgastro.2018.14 · Cited by 100 · see citing works
Enterprising or altruistic selves? Making up research subjects in genetics research
Tutton, R., & Prainsack, B. (2011) · Sociology of Health & Illness · doi:10.1111/j.1467-9566.2011.01348.x · Cited by 90 · see citing works
Mitra, A., Grossman Biegert, G. W., Delgado, A. Y., Karpinets, T. V., Solley, T. N., Mezzari, M. P., Yoshida-Court, K., Petrosino, J. F., Mikkelson, M. D., Lin, L., et al. (2020) · International Journal of Radiation Oncology*Biology*Physics · doi:10.1016/j.ijrobp.2019.12.040 · Cited by 90 · see citing works
Fang, H., Harris, S. C., Liu, Z., Zhou, G., Zhang, G., Xu, J., Rosario, L., Howard, P. C., & Tong, W. (2016) · Drug Discovery Today · doi:10.1016/j.drudis.2016.06.006 · Cited by 56 · see citing works
Cho, Y., Zhang, H., Harris, M. R., Gong, Y., Smith, E. L., & Jiang, Y. (2021) · Journal of Medical Internet Research · doi:10.2196/24638 · Cited by 53 · see citing works
Rocque, G. B., Dionne-Odom, J. N., Stover, A. M., Daniel, C. L., Azuero, A., Huang, C.-H. S., Ingram, S. A., Franks, J. A., Caston, N. E., Dent, D. A. N., et al. (2022) · BMC Health Services Research · doi:10.1186/s12913-022-07914-6 · Cited by 27 · see citing works
Self-citationEvon, D. M., Golin, C. E., Ruffin, R., Ayres, S., & Fried, M. W. (2018) · Pilot and Feasibility Studies · doi:10.1186/s40814-018-0285-5 · Cited by 8 · see citing works
“Many clinical hepatology studies are based on clinician-reported adverse events or improvements, which do not correlate well with patient-reported harms or improvements [14, 15].”
Background
- Authors
- Basch, E.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- Corresponding author
- Basch, Ethan
- ORCID
- Basch, Ethan
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-03-11
- Volume
- 362
- Issue
- 10
- Pages
- 865-869
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3031980
- OpenAlex
- W2050104081
- Cited by
- 646
- References
- 4
- Citations by year
- 2026: 27 · 2025: 37 · 2024: 51 · 2023: 37 · 2022: 39 · 2021: 37 · 2020: 49 · 2019: 45 · 2018: 52 · 2017: 56 · 2016: 49 · 2015: 31 · 2014: 24 · 2013: 35 · 2012: 34
- FWCI
- 47.97
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- UNC Libraries
- Funders
- National Cancer Institute (K07CA124851)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
- Keywords
- drug safety reporting, adverse drug reactions, patient participation, adverse event reporting, prescription drug labeling, patient awareness
- MeSH terms
- Drug Labeling, Humans, Patient Participation, Surveys and Questionnaires, United States, United States Food and Drug Administration, Adverse Drug Reaction Reporting Systems, Government Regulation, Drug-Related Side Effects and Adverse Reactions
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