Figures
- FIGURE 1
PRISMA-S flow diagram reporting the systematic review results. ALRI: acute lower respiratory infection; PRO: patient-reported outcome.
Tables
- TABLE 1
Characteristics of patient-reported outcome measures identified through systematic review
Records using the PROM PROM utilised Description of the PROM
tool items and domainsTarget population for the PROM use Year of PROM development Recall period Response scale description Jacobs et al. [7]
Whitley et al. [11]
Johnston et al. [12]
Chen et al. [16]
Bongard et al. [15]Canadian Acute Respiratory Illness and Flu Scale 18 items covering the domains of respiratory symptoms, activity limitation and behavioural impact Children with respiratory infection (validated in under 12s) 1997 Twice daily for first week, once on days 10 and 14 Four-point Likert scale Williams et al. [13]
Lewis et al. [17]Gilead Respiratory Syncytial Virus Caregiver Diary 26 items covering the domains of respiratory symptoms and behavioural impact <24 months of age with respiratory syncytial virus 2018 Twice daily Five/six-point Likert scale Bruyndonckx et al. [14]
Bongard et al. [15]EuroQol-Five Dimensions-Youth Generic health status in terms of five items, including symptoms, activity limitations and behavioural impact Intended for use in 8–15 year olds NR Once daily each week for 4 weeks Three-level scale, death to full health Santanello et al. [18]
Sarrell et al. [20]
Bisgaard et al. [21]Bronchiolitis Caregiver Diary Three items of respiratory symptoms Infants aged 2–5 years with recurrent wheeze 1999 Once daily Six-point Likert scale Little et al. [19] Adapted Measure Yourself Medical Outcome Profile Nine items covering the domains of respiratory symptoms and activity limitation NR 2001 Once daily Six-point Likert scale Tran et al. [23] Bronchitis Severity Scale Five items of respiratory symptoms Patients with respiratory infection 1996 Once daily rated by a clinician with patient assistance Five-point Likert scale Wat et al. [22] Asthma Symptom Diary Nine items covering the domains of respiratory symptoms and activity limitation Patients aged 9–11 years with asthma 1995 Twice daily Four-point Likert scale Kruizinga et al. [24] Symptom questionnaire Seven items covering the domains of respiratory symptoms, activity limitation and behavioural impact Adult pneumonia patients aged 21–96 years 2004 Once daily Differing per item; binary responses and three/four/five/six-point Likert scales Heinonen et al. [25]
Matilla et al. [27]Symptom diary Four items covering the domains of respiratory symptoms and activity limitation Children between 1 and 3 years with influenza NR Twice daily first week, once daily thereafter Four-point Likert scale Barratt et al. [26] Symptom diary Eight items covering the domains of respiratory symptoms and activity limitation Community-acquired pneumonia patients older than 6 months NR Once daily Five-point Likert scale NR: not reported; PROM: patient-reported outcome measure.
- TABLE 2
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 siteCorrelates 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.
Supplementary Material
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Supplementary material ERR-0229-2022.supplement
Vol 32 Issue 167
Table of Contents
Patient-reported outcome measures for paediatric acute lower respiratory infection studies
