Background Kaplan (2003) wrote a key paper on the significance of quality of life (QOL) in health care. His perspective on the traditional medical model versus a QOL outcomes model of patient care has an impact on the treatment of all disease. The traditional medical model emphasizes diagnosis and disease-specific outcomes, while the QOL model emphasizes health-related QOL. Greenberg (2003) found that AOM significantly reduces QOL for the child and parents and causes substantial use of medical services and a significant loss of workdays.
Objective To assess the frequency that QOL outcomes were addressed in AOM clinical trials published 1994-2004.
Method We (S.S.G., D.P.M.) conducted a literature search of clinical trials on AOM in children: 1994-2004. We independently reviewed 62 articles from 17 journals for 11 QOL issues: pain, activity, irritability, number of office visits, number of telephone calls, missed school or work, cost of medication, adverse events (including perforation of the tympanic membrane), parent satisfaction, and requirement for ENT referral. We then compared and discussed our results to resolve any differences of interpretation. The data were then entered into a database. Fifty-one articles met the criteria for inclusion in the final analysis. These were exclusively clinical trials on uncomplicated AOM in children.
Results Pain was most frequently assessed as an outcome: 98% (50/51 articles). Adverse events were assessed in 90% of the articles and irritability was assessed in 78%. Activity, perforation, and satisfaction were assessed in 35%, 18%, and 12%, respectively. Missed school/work was only assessed in 6% of the trials and ENT referral was assessed in 4%. None of the trials evaluated office visits, telephone calls, or cost of medication. The highest number of QOL issues was addressed in two articles (6 out of a possible 11 QOL outcomes). Seventy-six percent of the articles addressed at least three QOL issues and 35% addressed at least four. One article addressed only one QOL issue.
Conclusions Investigators need to assess QOL issues as important outcomes of AOM treatment. As Greenburg 2003 showed, AOM places a burden on patients and their families. Treating a patient should not only be about eradicating the causative organism, it should also be directed at increasing the well-being of the child and his/her family. Also, as stated by Greenberg, emphasis placed on QOL issues in AOM should help to motivate the development of preventive measures such as AOM vaccines.
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