Table 5.
Summary of Methodological Quality and Strength of the Evidence for Each Patient-Reported Outcome Measure Property
| PROM (author) | Construct | Evaluated measurement properties (+/−/?)a | Methodological quality | Summary | GRADEb |
Quality of evidence for each measurement property (points downgraded) | ||
|---|---|---|---|---|---|---|---|---|
| Risk of bias (points downgraded) | Imprecision due to sample size (points downgraded) | Indirectness (points downgraded) | ||||||
| Fatigue thermometer (Brand et al.)57 | Cancer-related fatigue | Hypothesis testing for construct validity (−) | Doubtful | Criterion validity tested but not using gold standard. Showed utility with multidimensional fatigue scale but no sensitivity and specificity. | Very serious as only one study of doubtful quality (−2) | n = 142 (0) | Population 12–32 years, mean age 20.24 years, SDc 4.81 (0) | Low (−2) |
| Pain thermometer (Chordas et al.)58 | Pain | Hypothesis testing for construct validity (−) | Doubtful | Criterion validity tested but not using gold standard. Comparator not validated. Showed utility with brief pain survey but no sensitivity and specificity. | Very serious as only one study of doubtful quality (−2) | n = 99 (0)c | Population 13–32 years, mean age 19.95 years (0) | Low (−2) |
| Perceived Barriers Scale (Strauser et al.)59 | Barriers to employment and career development | Structural validity. Exploratory factor analysis demonstrates two factors account for 57% variance (+) | Adequate | Exploratory factor analysis performed, not confirmatory factor analysis | Serious as one study of adequate quality (−1) | n = 110 (0) | Population 18–30, mean age 23.05 years, SD 3.36 (0) | Moderate (−1) |
| Internal consistency, Cronbach α > 0.7 (+) | Very good | Only relevant if based on reflexive model—unable to determine whether Perceived Barriers Scale is based on reflexive model. | No risk of bias (0) | High | ||||
| Hypothesis testing for construct validity (+) | Adequate | Comparator instruments not tested in same populations | Serious as one study of adequate quality (−1) | Moderate (−1) | ||||
| PedsFACT BrS (Yoo et al.)60 | Quality of life | Internal consistency Cronbach α > 0.7 (+) | Very good | Cronbach alpha's calculated, all >0.7 | No risk of bias (0) | n = 161 (0) | Population 13–18 years, mean age 15.53 years, SD 1.95 (−1) | Moderate (−1) |
| Reliability (internal consistency coefficients) Cronbach α 0.81 and 0.94 (+) | Adequate | Assumable patients were stable in time interval, no information reported. | Serious (−1) | Low (−2) | ||||
| Hypothesis testing for construct validity (+) | Adequate | Comparator instrument validated in a younger population (mean age 9.8 years) and only 7% of this population had a brain tumor (Lai et al., 2007). Testing only for correlates for anxiety and depression not all areas of Quality of Life | Serious (−1) | Low (−2) | ||||
| Hypothesis testing for known group validity (+) | Very good | Karnofsky scores, treatment types and treatment status described clearly. Correlations as expected. | No risk of bias (0) | Moderate (−1) | ||||
a
Measurement properties rated as sufficient (+), insufficient (−), indeterminate (?).
b
Per PROM, there was only one evaluation per measurement property, “inconsistency” did not apply. We, therefore, used the modified GRADE approach to grade the quality of evidence.
c
As the sample size was only one participant below the recommended threshold of 100 for downgrading, we did not downgrade Chordas et al.
COSMIN, consensus-based standards for the selection of health measurement instruments; GRADE, the grading of recommendations of assessment, development, and evaluation.