Comparing physicians' and patients' reporting on adverse reactions in randomized trials on acupuncture-a secondary data analysis.
Acupuncture
Adverse reaction
Patients’ reports
Safety documentation
Journal
BMC complementary and alternative medicine
ISSN: 1472-6882
Titre abrégé: BMC Complement Altern Med
Pays: England
ID NLM: 101088661
Informations de publication
Date de publication:
22 Aug 2019
22 Aug 2019
Historique:
received:
30
04
2019
accepted:
12
08
2019
entrez:
24
8
2019
pubmed:
24
8
2019
medline:
31
12
2019
Statut:
epublish
Résumé
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. 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. 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. 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 31438954
doi: 10.1186/s12906-019-2638-x
pii: 10.1186/s12906-019-2638-x
pmc: PMC6704486
doi:
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
223Subventions
Organisme : German statutory health insurances
ID : n/a
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