FRI0517 POSSIBLE EARLY DETECTION OF ADVERSE EVENTS USING A STRUCTURED, STANDARD, 60-SYMPTOM CHECKLIST ON A MULTIDIMENSIONAL HEALTH ASSESSMENT QUESTIONNAIRE (MDHAQ)
Authors: K. Schroeder, S. Abu Mehsen, I. Castrejon, T. Pincus
Journal: Annals of the Rheumatic Diseases (2020)

Background: Adverse events of medications are reported to account for 5% of hospital admissions in the USA, including 10% in the elderly, despite extensive warnings to patients by health professionals and pharmacies concerning the problem. Some adverse events are relatively obvious, such as a severe rash or severely abnormal laboratory test. However, many adverse events are common symptoms, such as headache or fatigue, which may not necessarily be recognized as adverse events, particularly in elderly patients with many comorbidities. In clinical trials and other clinical research, a structured, standard, protocol-driven symptom checklist is recorded according to the “scientific method.” In routine care, by contrast, recognition and recording of adverse events is elicited by health professionals at patient encounters or contact initiated by patients between visits, as “subjective” medical history information, which may be highly variable. Use of a standard symptom checklist on an electronic patient questionnaire has been reported in oncology, pulmonology and other specialties, but not in rheumatology. A multidimensional health assessment questionnaire (MDHAQ) includes a standard 60-symptom checklist, to recognize comorbidities, provide a review of systems, and serve on a fibromyalgia assessment screening tool (FAST3) as a clue to identify patients with fibromyalgia. The MDHAQ 60–symptom checklist can identify new symptoms after initiation of a medication which may be adverse events. Objectives: To analyze an MDHAQ 60-symptom checklist as a cost-effective approach to recognize medication-associated adverse events. Methods: All patients at one site complete an MDHAQ at each visit, which includes a standard, structured 60-symptom checklist, in addition to RAPID3 (routine assessment of patient index data) and FAST3. Paper MDHAQs from routine care are scanned into an Epic electronic medical record (EMR) and copied into a data repository for retrospective analyses. A list of common adverse events of many specific DMARDs (disease-modifying antirheumatic drugs) and biological agents used to treat rheumatoid arthritis (RA) was compiled from websites of the FDA, pharmaceutical companies, and Up-to-date.® Most listed symptoms are found on the structured MDHAQ 60-symptom checklist. A retrospective review of scanned MDHAQs at the first visit was conducted to recognize the presence or absence of self-reported symptoms which were listed as common adverse events for specific DMARDs on the MDHAQ 60-symptom checklist, using simple descriptive statistics. Only methotrexate (Mtx) is presented here due to space limitations. Results: All symptoms listed as adverse events of specific DMARDs were reported at higher frequencies in 379 DMARD-treated RA patients or 153 Mtx-treated patients, compared to 149 DMARD-naïve patients (Table). More than 30% of DMARD-treated patients reported headache and/or unusual fatigue, 27% anxiety; 10-20% cough, dizziness, hair loss, nausea, skin rash or hives, stomach pain or cramps, eye problems, and/or weight loss; and 5-10% diarrhea, fever, and/or mouth sores (Table). Similar proportions were seen for Mtx-treated patients, although anxiety and cough were not listed as specific adverse events. Conclusion: The MDHAQ symptom checklist may prove valuable to detect adverse events of high-risk medications, including on an electronic MDHAQ, which could be completed at home for 12 weeks after initiation of a new medication as a cost-effective approach for early detection of adverse events. Symptom listed on MDHAQ/MEDI60 DMARD naïve N=149 (28%) DMARD treated N=379 (72%) Methotrexate N=153 (29%) Headache 28% 36% 36% Unusual fatigue 31% 33% 34% Anxiety 23% 27% Cough 16% 18% Dizziness 14% 18% 20% Hair loss 10% 17% 19% Nausea 11% 13% 18% Skin rash or hives 11% 14% 13% Stomach pain/cramps 9% 16% 15% Eye problems 9% 13% 14% Anorexia/weight loss 10% 16% 17% Diarrhea 5% 9% 8% Fever 5% 8% 7% Mouth sores 3% 7% 8% Disclosure of Interests: Kyle Schroeder: None declared, Sara Abu Mehsen: None declared, Isabel Castrejon: None declared, Theodore Pincus Shareholder of: Dr. Pincus holds a copyright and trademark on MDHAQ and RAPID3 for which he receives royalties and license fees from profit-making organizations, all of which are used to support further development of quantitative clinical measures for patients and health professionals.