How well do patient reports reflect adverse drug reactions reported by rheumatologists? Agreement of physician- and patient-reported adverse events in patients with rheumatoid arthritis observed in the German biologics register

Gäwert, Lotta; Hierse, Franka; Zink, Angela; Strangfeld, Anja

doi:10.1093/rheumatology/keq300

Cited by 37 publications

(27 citation statements)

References 17 publications

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“…The total Cohen's kappa value was 0.15, which represents slight agreement, and was similar to our results. For rheumatoid arthritis, the reporting of adverse drug events between patients (n = 4246) and physicians differed; even for serious adverse events, the agreement was only 37% [58], whereas patients reported more events, which is similar to our results. In a study comparing adverse events reported in postdischarge patient interviews with adverse events detected by medical record review, the agreement for adverse events (kappa = 0.20) and serious adverse events (kappa = 0.33) was low and comparable to our agreement results [59].…”

Section: Discussionsupporting

confidence: 88%

Comparing physicians’ and patients’ reporting on adverse reactions in randomized trials on acupuncture—a secondary data analysis

Schwaneberg

Witt

Roll

et al. 2019

BMC Complement Altern Med

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Background: We aimed to compare patients' and physicians' safety reporting using data from large acupuncture trials (44,818 patients) and to determine associations between patient characteristics and reporting of adverse reactions. Methods: Six pragmatic randomized trials with an additional non-randomized study arm that included those patients who refused randomization were evaluated. Patients received acupuncture treatment for osteoarthritis of the hip or knee, chronic neck pain, chronic low back pain, chronic headache, dysmenorrhea, or allergic rhinitis or asthma. Safety outcomes were evaluated by questionnaires from both the physicians and the patients. To determine level of agreement between physicians and patients on the prevalence of adverse reactions, Cohen's kappa was used. With multilevel models associations between patient characteristics and reporting of adverse reactions were assessed. Results: Patients reported on average three times more adverse reactions than the study physicians: for bleeding/ haematoma, 6.7% of patients (n = 2458) vs. 0.6% of physicians (n = 255) and for pain, 1.7% of patients (n = 636) vs. 0.5% of physicians (n = 207). We found only minor agreements between patients and physicians (maximum Cohen's kappa: 0.50, 95% confidence interval [0.49;0.51] for depressive mood). Being a female and participation in the randomization were associated with higher odds of reporting an adverse reaction. Conclusions: In our study, patients' and physicians' reports on adverse reactions of acupuncture differed substantially, possibly due to differences in patients' and physicians' questionnaires and definitions. For the assessment of safety, we strongly support the inclusion of patients' and physicians' reports while ensuring standardization of data collection and definitions.

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Section: Discussionsupporting

confidence: 88%

Comparing physicians’ and patients’ reporting on adverse reactions in randomized trials on acupuncture—a secondary data analysis

Schwaneberg

Witt

Roll

et al. 2019

BMC Complement Altern Med

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“…It has, however, been shown that healthcare professionals downgrade the severity of ADEs experienced by patients [ 4 ]. Additionally, it has been shown that healthcare professionals underestimate symptomatic, subjective ADEs [ 4 - 7 ]. In a literature review, it was for instance shown that ADE rates of constipation with the use of the glucose-lowering drug metformin ranged from 0.6-1.0% when reported by healthcare professionals, and was 21% when reported by patients [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

“…This acknowledgement is especially the case for many symptomatic ADEs for which there is no objective test. Assessment of such ADEs is important, since they influence a patient’s quality of life (QOL) [ 7 ]. Previous studies showed that an increase in total scores of the number, frequency, and severity of experienced ADEs is associated with a decrease in QOL [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

Construct and concurrent validity of a patient-reported adverse drug event questionnaire: a cross-sectional study

Vries

Haaijer‐Ruskamp

Zeeuw

et al. 2014

Health Qual Life Outcomes

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BackgroundDirect patient-reported information about adverse drug events (ADEs) is important since it adds to healthcare professional-reported information about the safety of drugs. Previously, we developed an instrument to assess patient-reported ADEs in research settings. The aim of this study is to assess the construct and concurrent validity of the questionnaire.MethodsPatients on at least an oral glucose-lowering drug completed the ADE questionnaire, the World Health Organization Quality of Life-BREF, and the Treatment Satisfaction Questionnaire for Medication (TSQM). The ADE questionnaire assesses ADEs for any drug that the patient uses. Construct validity was assessed by testing whether patients reporting an ADE had a lower general quality of life and physical health than those not reporting an ADE, using Mann–Whitney U-tests and t-tests (significance level <0.05). For concurrent validity, we tested whether ADEs that patients associate with particular drugs in the ADE questionnaire are documented in the Summary of Product Characteristics (SPC) of those drugs, and whether patients who report an ADE with the use of metformin on the TSQM, mention metformin as a drug associated with an ADE on the ADE questionnaire. Agreement of 70% with the SPC was considered satisfactory. Sensitivity and positive predictive value (PPV) were calculated for the comparison with the TSQM, where 70% was used as the cut-off level for sufficient concurrent validity.ResultsWe included 135 patients (mean age 64 years, 35% women). Patients who reported an ADE (N = 37) had a lower general quality of life and physical health than those not reporting an ADE (P < 0.05). For 78 of the 146 reported ADEs (53%), patients mentioned at least 1 particular drug associated with the ADE. After clustering related ADEs, this resulted in 56 patient-reported ADE-drug associations. Of these, 41 (73%) were in agreement with information in the SPC. Finally, the questionnaire had a sensitivity of 38% and PPV of 79% for assessing ADEs associated with metformin.ConclusionsThe construct validity of the patient-reported ADE questionnaire was sufficient for reporting any versus no ADE, but the concurrent validity was only partly demonstrated. Therefore, the questionnaire needs to be adapted before it can be used.Electronic supplementary materialThe online version of this article (doi:10.1186/s12955-014-0103-6) contains supplementary material, which is available to authorized users.

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“…This may result from clinicians not asking the right questions or not listening to patients’ answers, but there are also reasons to believe that patients sometimes feel inhibited discussing symptoms with doctors. Whatever the cause, it is surely not good medicine when we find that, for instance, the rate of appetite loss reported by cancer patients is six times higher than the rate documented in case notes [1], or where drug-related toxicities are reported at a 50% higher incidence by rheumatology patients than their doctors [2]. …”

mentioning

confidence: 99%

Manifesto: towards a clinically-oriented psychometrics

Chen

2017

Health Qual Life Outcomes

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BackgroundNew technologies to collect patient - reported outcomes have substantially solved the challenge of integrating a questionnaire in a busy clinical practice. At Memorial Sloan Kettering, we have been collecting patient reported outcomes electronically for many years. Our experience confirms the predicted benefits of obtaining patient reported outcomes but has also raised serious concerns about whether instruments developed for the research setting are appropriate for routine clinical use.DiscussionWe summarize four principles for a clinically - relevant psychometrics. First, minimize patient burden: the use of a large number of items for a single domain may be of interest for research but additional items have little clinical utility. Secondly, use simplified language: patients who do not have good language skills are typically excluded from research studies but will nonetheless present in clinical practice. Third, avoid dumb questions: many questionnaire items are inappropriate when applied to a more general population. Fourth, what works for the group may not work for the individual: group level statistics used to validate survey instruments can obscure problems when applied to a subgroup of patients.ConclusionThere is a need for a clinically-oriented psychometrics to help design, test, and evaluate questionnaires that would be used in routine practice. Developing statistical methods to optimize questionnaires will be highly challenging but needed to bring the potential of patient reported outcomes into widespread clinical use.

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How well do patient reports reflect adverse drug reactions reported by rheumatologists? Agreement of physician- and patient-reported adverse events in patients with rheumatoid arthritis observed in the German biologics register

Cited by 37 publications

References 17 publications

Comparing physicians’ and patients’ reporting on adverse reactions in randomized trials on acupuncture—a secondary data analysis

Comparing physicians’ and patients’ reporting on adverse reactions in randomized trials on acupuncture—a secondary data analysis

Construct and concurrent validity of a patient-reported adverse drug event questionnaire: a cross-sectional study

Manifesto: towards a clinically-oriented psychometrics

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