| 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?) |
Daily rhinitis diary card to record allergic rhinitis and conjunctivitis symptoms with a 4‐point scale (0 to 3) for both daytime (completed in the evening) and night‐time (completed on awakening) |
| Omissions (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?) |
The score has a very limited focus and only evaluated allergic rhinitis and conjunctivitis symptoms. It does not evaluate functional impairments, quality of life or the impact of the disease on parents' and carers' quality of life. |
| If randomised 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?) |
The symptom score yields an overall score representing the severity of the symptoms in the patient |
| 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?) |
There was no indication that the measurement tool was validated previously or in this study |
| Did the instruments work in the way they were supposed to work? (Ability to measure change) (Are the PROs able to detect change in patient status, even if those changes are small?) |
There were changes reported in the symptom score |
| Can you make the magnitude of effect (if any) understandable to readers? (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)) |
It is possible but as the trialists only reported medians we were unable to report it in this review |
| Table 17.6.a from Patrick D, Guyatt GH, Acquadro C. Chapter 17: Patient‐reported outcomes. In: Higgins JPT, Green S (editors), Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 (updated September 2008). The Cochrane Collaboration, 2008. Available from www.cochrane‐handbook.org. This table is 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 (Guyatt 1997; Lohr 2002; Patrick 1993; Zaza 2000). |
