Development and preliminary evaluation of a parent-reported outcome instrument for clinical trials in acute otitis media

Pediatric Infectious Disease Journal

Volumn 28, Issue 1, 2009, Pages 5-8

  Shaikh, Nader ^a   Hoberman, Alejandro ^a   Paradise, Jack L ^a   Wald, Ellen R ^a   Switze, Galen E ^b   Kurs Lasky, Marcia ^c   Colborn, D Kathleen ^d   Kearney, Diana H ^a   Zoffel, Lisa M ^a,e  

^a CHILDREN S HOSPITAL OF PITTSBURGH   (United States)

^b UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^c UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^d UNIVERSITY OF PITTSBURGH   (United States)

^e VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

Acute otitis media; patient reported outcome measure; pediatrics; validation study

Indexed keywords

ACUTE OTITIS MEDIA; ACUTE OTITIS MEDIA SEVERITY OF SYMPTOM SCALE; ARTICLE; BACTERIAL COLONIZATION; CHILD; CLINICAL TRIAL; DISEASE SEVERITY; EVALUATION; FEMALE; FOLLOW UP; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PARENT; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; QUESTIONNAIRE; RATING SCALE; SYMPTOMATOLOGY; UPPER RESPIRATORY TRACT INFECTION;

ACUTE DISEASE; ADULT; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; FEMALE; HUMANS; INFANT; MALE; OTITIS MEDIA; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS; SELF DISCLOSURE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 66149143467     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e318185a387     Document Type: Article

References (14)

1. American Academy of Pediatrics Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics. 2004;113:1451-1465.
2. Dagan R, McCracken GH Jr. Flaws in design and conduct of clinical trials in acute otitis media. Pediatr Infect Dis J. 2002;21:894-902.
3. Kaleida PH, Casselbrant ML, Rockette HE, et al. Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial. Pediatrics. 1991;87:466-474.
4. US Department of Health and Human Services FDA Center for Drug Evaluation and Research; US Department of Health and Human Services FDA Center for Biologics Evaluation and Research; US Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006;4:79.
5. Rosenfeld RM, Goldsmith AJ, Tetlus L, et al. Quality of life for children with otitis media. Arch Otolaryngol Head Neck Surg. 1997;123:1049-1054.
6. Friedman NR, McCormick DP, Pittman C, et al. Development of a practical tool for assessing the severity of acute otitis media. Pediatr Infect Dis J. 2006;25:101-107.
7. Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995;273:59-65.
8. Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. Can Med Assoc J. 1986;134:889-895.
9. Juniper EF, Guyatt GH. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy. 1991;21:77-83.0
10. Deyo RA, Diehr P, Patrick DL. Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation. Control Clin Trials. 1991;12(Suppl 4):142S-158S.
11. Guyatt G, Walter S, Norman G. Measuring change over time: assessing the useful-ness of evaluative instruments. J Chronic Dis. 1987;40:171-178.
12. Le Saux N, Gaboury I, Baird M, et al. A randomized, double-blind, placebo-controlled noninferiority trial of amoxicillin for clinically diagnosed acute otitis media in children 6 months to 5 years of age. Can Med Assoc J. 2005;172:335-341.
13. Little P, Gould C, Williamson I, et al. Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media. BMJ. 2001; 322:336-342.
14. McCormick DP, Chonmaitree T, Pittman C, et al. Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment. Pediatrics. 2005;115:1455-1465.