TABLE 2.
PROPOSED RANKING OF DIAGNOSTIC CERTAINTY FOR WHEEZE DEFINITIONS IN PEDIATRIC VACCINE AND DRUG TRIALS
| Wheeze Definition | Sensitivity | Specificity | Inter rater agreement | Diagnostic Certainty (range 0–6) | Example Study |
|---|---|---|---|---|---|
| COMBINED CAREGIVER REPORT AND HEALTH WORKER ASSESSMENT | |||||
| Caregiver report using diary or other memory aid, active surveillance, and follow-up with clinician. Clinician diagnosed wheeze verified by computer assisted technique/2 clinicians/algorithmic approach. | High | High | High | 6 | Not used in a study |
| Caregiver report using diary or other memory aid, active surveillance, and follow-up with clinician | High | High | Moderate | 5 | Not used in a study |
| Active surveillance for wheeze via phone calls, followed by visit by study nurse | High | High | Moderate | 5 | Piedra, 1996[31] |
| HEALTH WORKER ASSESSMENT | |||||
| Clinician diagnosed wheeze verified by computer assisted technique | Moderate | High | High | 5 | Not used in a study |
| Wheeze verified by two physicians | Moderate | High | High | 5 | Not used in a study |
| Clinician diagnosed wheeze employing an algorithmic approach | Moderate | High | High | 5 | Not used in a study |
| Medically attended wheeze -defined as presence of wheezing on a physical examination conducted by a health care provider, for a patient with signs of respiratory distress [severity assessment] | Moderate | High | High | 5 | Belshe, 1982 [32] |
| Daily clinical observation | Moderate | High | Moderate | 4 | Wright, 1976 [13] |
| Physician verified wheeze (no required severity) | Moderate | High | Moderate | 4 | Custovic, 2002 [33] |
| Surveillance of medical visits to hospitals and emergency rooms for wheeze asthma and other respiratory symptoms | Moderate | High | Moderate | 4 | Bergen, 2004 [2] |
| Clinical observation immediately after vaccine administration | Low | High | Moderate | 3 | Greenhawt, 2012 [34] |
| Retrospective review of ICD-9 codes for asthma or reactive airway disease | Low | High | Moderate | 2 | Gaglani 2008 [4] |
| CAREGIVER REPORT | |||||
| Asthma symptoms assessed using ISAAC questionnaire by parent | High | Low | High | 4 | Kiraly, 2013 [35] |
| Caregiver report using diary or other memory aid, and active surveillance via daily or weekly telephone calls | High | Moderate | Moderate | 4 | Esposito 2003 [36] |
| Daily active surveillance for respiratory symptoms including wheeze by telephone by study staff | High | Moderate | Moderate | 4 | Anderson, 1992 [14] |
| Caregiver report using a diary or other memory aid | Moderate | Low | Low | 1 | Rose, 2010 [37] |
| Caregiver recording of any serious adverse events and passive surveillance | Low | Low | Low | 0 | Tam, 2007 [15] |
Scoring: High=2, Moderate=1, Low=0. Add scores across all three components of diagnostic certainty. Higher scores= higher diagnostic certainty. All scores are for assessing any wheeze. Scores assumed healthcare workers are well trained.