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Authors used a range of methods to record adverse events including self report, open ended questions, structured questionnaires, side effect checklists, and case reports coded to the Medical Dictionary for Regulatory Activities (MedDRA, www.meddra.org).
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The confirmation period requires patients to complete the 5-point Likert questionnaire side-by-side after wearing whichever denture they preferred during the 2-week period.
A questionnaire for side effects was administered at each visit.
A questionnaire on side effects will be administered to all participants at six-month intervals to monitor safety.
Moreover, a questionnaire called "Side-Effects of Psychotherapy" scale (SEPS), based on items of the Inventory of Negative Effects of Psychotherapy (INEP) [ 62], a scale assessing negative effects of psychotherapy in different areas of life, as well as items constructed by the workgroup assessing negative outcomes of the intervention, will be administered post treatment and follow-up.
Can you rely on questionnaires to measure side effects without also including appropriate investigations?
Questionnaires concerning any side effects of treatment were administered by ophthalmology nurses during daily visits to assigned villages.
Also before colonoscopy, patients completed questionnaires evaluating compliance, side effects, sleep, satisfaction, and willingness to repeat the purgative.
We think that questionnaires which list side effects, many of which are not specified, could possibly become obsolete as treatments evolve.
Both during NAC treatment (visits 0 3) and in the post-treatment period (visits 4 6) patients were seen two-weekly for follow-up visits during which questionnaires pertaining to side effects were completed, weight, blood pressure, and pulse were measured and a blood sample was drawn via venipuncture.
A 3-item questionnaire measuring medication side effect impact over the past week using 3 domains: frequency, intensity, and global burden (degree interfered with day-to-day functions).
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