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BMC Complementary Medicine and Therapies
Published in: BMC Complementary Medicine and Therapies 1/2019

Open Access 01-12-2019 | Acupuncture | Research article

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

Authors: Thea Schwaneberg, Claudia M. Witt, Stephanie Roll, Daniel Pach

Published in: BMC Complementary Medicine and Therapies | Issue 1/2019

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Abstract

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.
Appendix
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Literature
1.
Broom AF, Kirby ER, Sibbritt DW, Adams J, Refshauge KM. Use of complementary and alternative medicine by mid-age women with back pain: a national cross-sectional survey. BMC Complement Altern Med. 2012;12:98.PubMedPubMedCentralCrossRef
2.
Bussing A, Ostermann T, Heusser P, Matthiessen PF. Usage of complementary and alternative medicine interventions by German older adults. J Altern Complement Med. 2011;17(6):487–9.PubMedCrossRef
3.
Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998;280(18):1569–75.PubMedCrossRef
4.
Foltz V, St Pierre Y, Rozenberg S, Rossignol M, Bourgeois P, Joseph L, et al. Use of complementary and alternative therapies by patients with self-reported chronic back pain: a nationwide survey in Canada. Joint Bone Spine. 2005;72(6):571–7.PubMedCrossRef
5.
Thomas K, Coleman P. Use of complementary or alternative medicine in a general population in Great Britain. Results from the National Omnibus survey. J. Public Health (Oxf). 2004;26(2):152–7.CrossRef
6.
Xue CC, Zhang AL, Lin V, Myers R, Polus B, Story DF. Acupuncture, chiropractic and osteopathy use in Australia: a national population survey. BMC Public Health. 2008;8:105.PubMedPubMedCentralCrossRef
7.
Berman BM, Langevin HM, Witt CM, Dubner R. Acupuncture for chronic low back pain. N Engl J Med. 2010;363(5):454–61.PubMedCrossRef
8.
Brinkhaus B, Witt CM, Jena S, Linde K, Streng A, Wagenpfeil S, et al. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med. 2006;166(4):450–7.PubMed
9.
Yuan J, Purepong N, Kerr DP, Park J, Bradbury I, McDonough S. Effectiveness of acupuncture for low back pain: a systematic review. Spine (Phila Pa 1976). 2008;33(23):E887–900.CrossRef
10.
Liu L, Skinner M, McDonough S, Mabire L, Baxter GD. Acupuncture for low back pain: an overview of systematic reviews. Evid Based Complement Alternat Med. 2015;2015:328196.PubMedPubMedCentral
11.
Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, et al. Acupuncture for chronic pain: update of an individual patient data meta-analysis. The journal of pain : official journal of the American Pain Society. 2018;19(5):455–74.CrossRef
12.
Ernst E, White AR. Prospective studies of the safety of acupuncture: a systematic review. Am J Med. 2001;110(6):481–5.PubMedCrossRef
13.
Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, et al. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009;16(2):91–7.PubMed
14.
15.
16.
Wu J, Hu Y, Zhu Y, Yin P, Litscher G, Xu S. Systematic review of adverse effects: a further step towards modernization of acupuncture in China. Evid Based Complement Alternat Med. 2015;2015:432467.PubMedPubMedCentral
17.
Macpherson H, Scullion A, Thomas KJ, Walters S. Patient reports of adverse events associated with acupuncture treatment: a prospective national survey. Qual Saf Health Care. 2004;13(5):349–55.PubMedPubMedCentralCrossRef
18.
Zhang Q, Yue J, Golianu B, Sun Z, Lu Y. Updated systematic review and meta-analysis of acupuncture for chronic knee pain. Acupunct Med. 2017;35(6):392–403.PubMedCrossRef
19.
20.
Xu S, Wang L, Cooper E, Zhang M, Manheimer E, Berman B, et al. Adverse events of acupuncture: a systematic review of case reports. Evid Based Complement Alternat Med. 2013;2013:581203.PubMedPubMedCentral
21.
Cummings M. Modellvorhaben Akupunktur-a summary of the ART, ARC and GERAC trials. Acupunct Med. 2009;27(1):26–30.PubMedCrossRef
22.
Haake M, Muller HH, Schade-Brittinger C, Basler HD, Schafer H, Maier C, et al. German acupuncture trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007;167(17):1892–8.PubMedCrossRef
23.
Witt CM, Brinkhaus B, Jena S, Selim D, Straub C, Willich SN. Wirksamkeit, Sicherheit und Wirtschaftlichkeit der Akupunktur: Ein Modellversuch mit der Techniker Krankenkasse. Deutsches Ärzteblatt. 2006;103(4):196–203.
24.
Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, et al. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012;172(19):1444–53.PubMedPubMedCentralCrossRef
25.
26.
World Health Organization. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. 1995.
27.
28.
MacPherson H, Thomas K, Walters S, Fitter M. The York acupuncture safety study: prospective survey of 34 000 treatments by traditional acupuncturists. BMJ. 2001;323(7311):486–7.PubMedPubMedCentralCrossRef
29.
Witt CM, Jena S, Selim D, Brinkhaus B, Reinhold T, Wruck K, et al. Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain. Am J Epidemiol. 2006;164(5):487–96.PubMedCrossRef
30.
Witt CM, Jena S, Brinkhaus B, Liecker B, Wegscheider K, Willich SN. Acupuncture in patients with osteoarthritis of the knee or hip: a randomized, controlled trial with an additional nonrandomized arm. Arthritis Rheum. 2006;54(11):3485–93.PubMedCrossRef
31.
Witt CM, Jena S, Brinkhaus B, Liecker B, Wegscheider K, Willich SN. Acupuncture for patients with chronic neck pain. Pain. 2006;125(1–2):98–106.PubMedCrossRef
32.
Jena S, Witt CM, Brinkhaus B, Wegscheider K, Willich SN. Acupuncture in patients with headache. Cephalalgia. 2008;28(9):969–79.PubMedCrossRef
33.
Witt CM, Reinhold T, Brinkhaus B, Roll S, Jena S, Willich SN. Acupuncture in patients with dysmenorrhea: a randomized study on clinical effectiveness and cost-effectiveness in usual care. Am J Obstet Gynecol. 2008;198(2):166.e1–8.CrossRef
34.
Brinkhaus B, Witt CM, Jena S, Liecker B, Wegscheider K, Willich SN. Acupuncture in patients with allergic rhinitis: a pragmatic randomized trial. Ann Allergy Asthma Immunol. 2008;101(5):535–43.PubMedCrossRef
35.
Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141(10):781–8.PubMedCrossRef
36.
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255–9.PubMedCrossRef
37.
38.
Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37–46.CrossRef
39.
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159–74.PubMedCrossRef
40.
41.
42.
Liang KYZ, S. L. Longitudinal data analysis using generalized linear models. Oxf J. 1986;73:13–22.
43.
Ernst E, White A. Life-threatening adverse reactions after acupuncture? A systematic review. Pain. 1997;71(2):123–6.PubMedCrossRef
44.
Food and Drug Administration. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009.
45.
White A, Hayhoe S, Hart A, Ernst E. Adverse events following acupuncture: prospective survey of 32 000 consultations with doctors and physiotherapists. BMJ. 2001;323(7311):485–6.PubMedPubMedCentralCrossRef
46.
Endres HG, Molsberger A, Lungenhausen M, Trampisch HJ. An internal standard for verifying the accuracy of serious adverse event reporting: the example of an acupuncture study of 190,924 patients. Eur J Med Res. 2004;9(12):545–51.PubMed
47.
Food And Drug Administration. Food and drugs. Investigational New Drug Application. Safety Reporting. 2016.
48.
World Health Organization. The Importance of Pharmacovigilance. Safety Monitoring of Medicinal Products. 2002.
49.
European Medicines Agency. EphMRA Adverse Event Reporting Guidelines 2013. 2013. Report No.: EMA/873138/2011.
50.
51.
Wheway J, Agbabiaka TB, Ernst E. Patient safety incidents from acupuncture treatments: a review of reports to the National Patient Safety Agency. Int J Risk Saf Med. 2012;24(3):163–9.PubMed
52.
Bent S, Padula A, Avins AL. Brief communication: better ways to question patients about adverse medical events: a randomized, controlled trial. Ann Intern Med. 2006;144(4):257–61.PubMedCrossRef
53.
Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, et al. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011;12:87.PubMedPubMedCentralCrossRef
54.
Localio AR, Weaver SL, Landis JR, Lawthers AG, Brenhan TA, Hebert L, et al. Identifying adverse events caused by medical care: degree of physician agreement in a retrospective chart review. Ann Intern Med. 1996;125(6):457–64.PubMedCrossRef
55.
Baker GR, Norton PG, Flintoft V, Blais R, Brown A, Cox J, et al. The Canadian adverse events study: the incidence of adverse events among hospital patients in Canada. CMAJ. 2004;170(11):1678–86.PubMedPubMedCentralCrossRef
56.
Zegers M, de Bruijne MC, Wagner C, Groenewegen PP, van der Wal G, de Vet HC. The inter-rater agreement of retrospective assessments of adverse events does not improve with two reviewers per patient record. J Clin Epidemiol. 2010;63(1):94–102.PubMedCrossRef
57.
Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the quality-of-life questionnaire C30. J Clin Oncol. 2004;22(17):3485–90.PubMedCrossRef
58.
Gawert L, Hierse F, Zink A, Strangfeld A. 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. Rheumatology (Oxford). 2011;50(1):152–60.CrossRef
59.
Weissman JS, Schneider EC, Weingart SN, Epstein AM, David-Kasdan J, Feibelmann S, et al. Comparing patient-reported hospital adverse events with medical record review: do patients know something that hospitals do not? Ann Intern Med. 2008;149(2):100–8.PubMedCrossRef
60.
Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, et al. Patient versus clinician symptom reporting using the National Cancer Institute common terminology criteria for adverse events: results of a questionnaire-based study. Lancet Oncol. 2006;7(11):903–9.PubMedCrossRef
61.
Ioannidis JP, Lau J. Improving safety reporting from randomised trials. Drug Saf. 2002;25(2):77–84.PubMedCrossRef
62.
Smeby SS, Johnsen R, Marhaug G. Documentation and disclosure of adverse events that led to compensated patient injury in a Norwegian university hospital. Int J Qual Health Care. 2015;27(6):486–91.PubMedCrossRef
63.
Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005. Arch Intern Med. 2007;167(16):1752–9.PubMedCrossRef
64.
Hunsinger M, Smith SM, Rothstein D, McKeown A, Parkhurst M, Hertz S, et al. Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review. Pain. 2014;155(11):2253–62.PubMedCrossRef
65.
Trotti A, Colevas AD, Setser A, Basch E. Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol. 2007;25(32):5121–7.PubMedCrossRef
66.
Thomas KJ, MacPherson H, Thorpe L, Brazier J, Fitter M, Campbell MJ, et al. Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain. BMJ (Clinical research ed). 2006;333(7569):623.CrossRef
67.
Ribeiro-Vaz I, Silva AM, Costa Santos C, Cruz-Correia R. How to promote adverse drug reaction reports using information systems - a systematic review and meta-analysis. BMC Med Inform Decis Mak. 2016;16:27.PubMedPubMedCentralCrossRef
68.
Montastruc F, Bagheri H, Lacroix I, Damase-Michel C, Chebane L, Rousseau V, et al. Adverse drug reaction reports received through the mobile app, VigiBIP (R): a comparison with classical methods of reporting. Drug Saf. 2017.
69.
Christiaans-Dingelhoff I, Smits M, Zwaan L, Lubberding S, van der Wal G, Wagner C. To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports? BMC Health Serv Res. 2011;11:49.PubMedPubMedCentralCrossRef
Metadata
Title
Comparing physicians’ and patients’ reporting on adverse reactions in randomized trials on acupuncture—a secondary data analysis
Authors
Thea Schwaneberg
Claudia M. Witt
Stephanie Roll
Daniel Pach
Publication date
01-12-2019
Publisher
BioMed Central
Keyword
Acupuncture
Published in
BMC Complementary Medicine and Therapies / Issue 1/2019
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-019-2638-x

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