Information reported on the quality (validity, reliability, and responsiveness) of identified patient-reported outcome measures (PROMs)
| PROM | Number of validation studies reporting properties of measurement | Mode of administration | Quality | ||||
| Content validity | Convergent validity | Discriminant validity | Concurrent validity | Predictive validity | |||
| CARIFS | 1 | Parent-reported twice-daily written diary card | Items identified through a literature search. Items discussed by paediatricians and parents, who added additional items and then ranked in terms of importance. Acceptable content validity | Correlated well with both health professional and parental measures (physician's assessment 0.36, nurse's assessments 0.44, Yale observation scale 0.48 and parental global visual analogue assessment 0.52) | A significant difference (p=0.007) was found between the children who had no further physician visits, one further visit and two or more visits or hospital attendance. The increase in duration was not statistically significant for the children with ear infections or antibiotics. No difference in baseline CARIFS scores according to age, viral aetiology, gender or study site | Correlates well with the Yale observation scale (0.48) and Parental Global Assessment Scale (0.52) | The CARIFS scores improved over the 14 days, consistent with clinical predictions of the course of respiratory infections. The CARIFS decreased from a mean±sd score on day 1 of 28.0±10.3 to 17.1±11.7 on day 3, and 2.5±5.7 on day 14 |
| GRCD | 1 | Caregiver-reported twice-daily written or electronic questionnaires | Identified constructs of interest through literature review, consultation with medical experts and direct input from caregivers. Interviews with adult caregivers informed GRCD item development | Construct validity correlations between the GRCD items and the clinician-reported outcomes were generally weaker than expected (r=−0.02–0.34), but correlations with the caregiver-reported PGIS were moderate to strong as hypothesised (r=0.30–0.63) except for those associated with overnight fussiness (r=0.29), overnight sleeping (r=0.14) and overnight stuffy nose (r=0.19) | Assessed via known-group ANOVAs and chi-squared tests examined mean differences in GRCD scores between patients classified based on CGIS and PGIS scores. Known-group analyses in support of item-level discriminating ability showed that means were typically higher for patients rated as more ill (84.2% of 57 ANOVAs), but few of these mean differences were statistically significant (14.0% of 57 ANOVAs) | Moderate to strong correlations with the caregiver-reported PGIS (r=0.30–0.63) | The correlations between item-level change from first day to last day and the PGIC at day 14 were generally moderate to strong |
| PROM | Quality | ||||
| Intra- or inter-rate and test–retest reliability | Internal consistency | Responsiveness | Measurement error | Minimal important difference | |
| CARIFS | Intra-class correlation coefficient reliability for the mothers on day 2 was a Cronbach's alpha score of 0.808 | Cronbach's alpha for the 18-item scale at enrolment was 0.89 | CARIFS decreased from a mean±sd score on day 1 of 28.0±10.3 to 17.1±11.7 on day 3 and 2.5±5.7 on day 14 | NR | NR |
| GRCD | Test–retest reliability was assessed via kappa coefficients and intraclass correlation coefficients were computed using the subset of patients assumed to be stable from day 13 (“test”) to day 14 (“retest”) because caregivers responded the same on the PGIC on both days. Item-level test–retest reliabilities range in strength from poor (overnight fever kappa =−0.00, daytime activity level kappa=−0.02) to perfect agreement (daytime fever kappa=1.00), with 17 of the 19 items achieving acceptable test–retest reliability | Demonstrated satisfactory internal consistency of (alphas=0.78–0.94) | All GRCD items showed substantial improvement in overnight and daytime symptoms over the course of the 2-week data collection. With respect to responsiveness, item-level effect size estimates of change were large (data not shown), ranging from −0.86 (overnight sleeping) to −3.55 (daytime cough severity); standardised response means were also large (data not shown), ranging from −0.79 (overnight sleeping) to −2.54 (daytime cough severity) | NR | NR |
CARIFS: Canadian Acute Respiratory Illness and Flu Scale; CGIS: Clinician Global Impression of Severity; GRCD: Gilead Respiratory Syncytial Virus Caregiver Diary; NR: not reported; PGIC: Parent Global Impression of Change; PGIS: Parent Global Impression of Severity.