Table 1.
Summary of Existing Guidance on Standards for HRQL Reporting in RCTs
| Gill 1994 | Staquet 1996 | Kong 1997 | Revicki 2000 | Lee 2000 | Sprangers 2002 | Movsas 2003 | Efficace 2003 | Wiklund 2004 | Abbott 2005 | Revicki 2005 | Tanvetyanon 2007 | Joly 2007 | Street 2009 | Temple 2009 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||||||||
| Study patient characteristics described | Y | Y | Y | ||||||||||||
| Title-explicit as to the RCT incorporating HRQL | Y | ||||||||||||||
| HRQL is a stated outcome in abstract | Y | Y | |||||||||||||
| Introduction includes summary of the previous HRQL research | Y | ||||||||||||||
| QOL is stated as a outcome/primary or secondary outcome | Y | Y | |||||||||||||
| Flow diagram provided/subject flow discussed | Y | Y | Y | Y | |||||||||||
| Instrument and admin | |||||||||||||||
| Rationale for HRQL instrument provided | Y | Y | Y | Y | Y | Y | Y | Y | Y | ||||||
| Was the instrument appropriate for the stated study hypothesis? | Y | Y | |||||||||||||
| Evidence of instrument reliability | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | ||
| Evidence of instrument validity | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | |||
| Adequacy of domains covered/domains of interest explicit | Y | Y | Y | Y | Y | Y | |||||||||
| Instrument administration reported | Y | Y | Y | ||||||||||||
| Instrument responsiveness to change | Y | Y | Y | Y | Y | Y | |||||||||
| Copy of instrument included if not published previously | Y | Y | |||||||||||||
| Citation for HRQL instrument provided | Y | Y | Y | Y | Y | ||||||||||
| Analysis and reporting | |||||||||||||||
| HRQL hypothesis stated | Y | Y | Y | Y | Y | Y | Y | Y | Y | ||||||
| Timing of HRQL measurement appropriate for clinical context | Y | Y | Y | Y | Y | Y | Y | Y | Y | ||||||
| Clinical rationale for sample size | Y | Y | Y | Y | |||||||||||
| Power/sample size calculation | Y | Y | Y | Y* | Y | Y | Y | Y | Y | ||||||
| Multiple QOL items adjustment | Y | Y | Y | Y | Y | Y | Y | ||||||||
| Missing data documented | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | |||||
| Reasons for missing data discussed | Y | Y | Y | Y | Y | Y | Y | Y | |||||||
| Statistical approaches taken to dealing with missing data | Y | Y | Y | ||||||||||||
| Baseline QOL status described | Y | Y | Y | Y | Y | Y | Y | Y | Y | ||||||
| All HRQL data provided not just the statistically significant data | Y | Y | Y | Y | Y | ||||||||||
| Use of appropriate statistical analysis/test of stat. sig. | Y | Y | Y | Y | Y | Y | |||||||||
| Post hoc analyses identified as such | Y | ||||||||||||||
| Survival difference accounted for | Y | Y | |||||||||||||
| Clinical significance addressed/MID stated | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | ||||
| Generalizability of the results described | Y | Y | |||||||||||||
| Mode of administration stated/methods of collecting data | Y | Y | Y | Y | |||||||||||
| Blinding of investigators and participants | Y | Y | |||||||||||||
| Other | |||||||||||||||
| Procedures for quality control | Y | Y | Y | Y | Y | Y | |||||||||
| Compliance monitoring | Y | Y | Y | ||||||||||||
| Pilot testing | Y | ||||||||||||||
| Authors provide composite score for quality of life | Y | ||||||||||||||
| Were patients asked to provide their own global rating for QOL? | Y | ||||||||||||||
| Was overall quality of life distinguished from HRQOL? | Y | ||||||||||||||
| Were patients invited to supplement the items in the instrument? | Y | ||||||||||||||
| Were the items incorporated into the final rating? | Y | ||||||||||||||
| Were patients asked which items were personally important? | Y | Y | |||||||||||||
| Were these important ratings incorporated into the final rating? | Y | ||||||||||||||
| Designated symptom or QOL domain as a primary endpoint | Y | ||||||||||||||
| Proportion achieving a pre-defined palliative response | Y | ||||||||||||||
| Estimates of the duration of palliative response | Y | ||||||||||||||
| Discussion of the limitations of the results | Y | ||||||||||||||
* When HRQL primary endpoint