Article type
Year
Abstract
Background:
To minimize bias during systematic reviews (SRs), outcomes should be completely pre-specified in the protocol, including: domain (title), specific measurement (instrument), specific metric (e.g. change from baseline), method of aggregation (e.g. mean), and time-points. Also, SRs must include patient-important outcomes (PIOs), as opposed to interim outcomes only.
Objectives:
To evaluate the number of outcomes per SR, extent of completeness of specification of outcomes and inclusion of PIOs in SRs on HIV/AIDS.
Methods:
The Cochrane Eyes & Vision Group, US Cochrane Center, South African Cochrane Centre, and Cochrane HIV/AIDS Group collaborated to assess all SRs published by the Cochrane HIV/AIDS Group by June 2013. For ongoing SRs, we included the published protocol. We extracted from the Methods section of each SR each outcome domain, the other four elements for that domain and whether that domain was a PIO.
Results:
We identified 140 SRs with a median of seven outcome domains each (range 1 to 30). Overall, there were 294 unique outcome domains, included a total of 1140 times (‘instances’). Outcome domains were each included median=2 (range 1 to 68) SRs. We developed a comprehensive classification system for outcome domains, with 14 major and 32 sub-categories. The largest major categories were clinical/biological (160/294 domains, 54%) and behavioral (51/294 domains; 17%) (Table). Overall, median=1 (range 1 to 4) element was specified per outcome. Domain, specific measurement, specific metric, method of aggregation, and time-points were specified for 100%, 9%, 16%, 12%, and 2.5% of instances respectively. We classified 747/1140 instances (66%) as PIOs. Most SRs (136/140; 97%) included at least one PIO (median=5; range 0 to 15 PIOs per SR).
Conclusions:
Cochrane SRs on HIV/AIDS include a large number of outcome domains and outcome pre-specification is incomplete. Almost two-thirds of outcomes are PIOs; the abundance of outcomes could limit SR utility for decision-makers. The classification system we developed could provide a useful framework for developing core outcome sets for primary and synthesis research in HIV/AIDS.
To minimize bias during systematic reviews (SRs), outcomes should be completely pre-specified in the protocol, including: domain (title), specific measurement (instrument), specific metric (e.g. change from baseline), method of aggregation (e.g. mean), and time-points. Also, SRs must include patient-important outcomes (PIOs), as opposed to interim outcomes only.
Objectives:
To evaluate the number of outcomes per SR, extent of completeness of specification of outcomes and inclusion of PIOs in SRs on HIV/AIDS.
Methods:
The Cochrane Eyes & Vision Group, US Cochrane Center, South African Cochrane Centre, and Cochrane HIV/AIDS Group collaborated to assess all SRs published by the Cochrane HIV/AIDS Group by June 2013. For ongoing SRs, we included the published protocol. We extracted from the Methods section of each SR each outcome domain, the other four elements for that domain and whether that domain was a PIO.
Results:
We identified 140 SRs with a median of seven outcome domains each (range 1 to 30). Overall, there were 294 unique outcome domains, included a total of 1140 times (‘instances’). Outcome domains were each included median=2 (range 1 to 68) SRs. We developed a comprehensive classification system for outcome domains, with 14 major and 32 sub-categories. The largest major categories were clinical/biological (160/294 domains, 54%) and behavioral (51/294 domains; 17%) (Table). Overall, median=1 (range 1 to 4) element was specified per outcome. Domain, specific measurement, specific metric, method of aggregation, and time-points were specified for 100%, 9%, 16%, 12%, and 2.5% of instances respectively. We classified 747/1140 instances (66%) as PIOs. Most SRs (136/140; 97%) included at least one PIO (median=5; range 0 to 15 PIOs per SR).
Conclusions:
Cochrane SRs on HIV/AIDS include a large number of outcome domains and outcome pre-specification is incomplete. Almost two-thirds of outcomes are PIOs; the abundance of outcomes could limit SR utility for decision-makers. The classification system we developed could provide a useful framework for developing core outcome sets for primary and synthesis research in HIV/AIDS.