Table 17.6.a: A checklist for describing and assessing PROs in clinical trials

Based on Chapter 7 of Patrick and Erickson, a Users’ Guide to the Medical Literature, CDC guidance for evaluation of community preventive services, and criteria used by the Medical Outcomes Trust (Patrick 1993, Guyatt 1997, Zaza 2000, Lohr 2002).

1.       What were PROs measuring?

a.       What concepts were the PROs used in the study measuring?

b.       What rationale (if any) for selection of concepts or constructs did the authors provide?

c.       Were patients involved in the selection of outcomes measured by the PROs?

2.       Omissions

a.       Were there any important aspects of health (e.g., symptoms, function, perceptions)  or quality of life (e.g. overall evaluation, satisfaction with life)  that were omitted in this study from the perspectives of the patient, clinician, significant others, payers, or other administrators and decision makers?

3.       If randomized trials and other studies measured PROs, what were the instruments’ measurement strategies?

a.       Did investigators use instruments that yield a single indicator or index number, a profile, or a battery of instruments?

b.       If investigators measure PROs, did they use specific or generic measures, or both?

c.       Who exactly completed the instruments?

4.       Did the instruments work in the way they were supposed to work – validity?

a.       Had the instruments used been validated previously (provide reference)? Was evidence of prior validation for use in this population presented?

b.       Were the instruments re-validated in this study?

5.       Did the instruments work in the way they were supposed to work – ability to measure change?

a.       Are the PROs able to detect change in patient status, even if those changes are small?

6.       Can you make the magnitude of effect (if any) understandable to readers? (You must!)

a.       Can you provide an estimate of the difference in patients achieving a threshold of function or improvement, and the associated number needed to treat (NNT).