Background HIV and Syphilis collectively infect about 70 million individuals. Both infections have long asymptomatic periods, making timely screening imperative for infection control. While enough evidence exists on diagnostic accuracy measures for point-of-care tests (POCTs), the quality of evidence on measures beyond accuracy is poor. We reviewed evidence on these implementation research outcomes (IROs) and summarised their quality.
Method Two reviewers systematically searched 10+ electronic databases for the period: January 1980-September 2012, independently abstracted data and synthesised outcomes narratively. Over 10,000 citations were screened and a final set of 191 studies identified for inclusion.
Results Of 191 studies, almost half 46%(n = 127) in HIV and 41% (n = 64) in syphilis, reported IROs. IROs included acceptability, preference, feasibility and impact. Across 16 studies, acceptability measure was reported as proportions, rates, without confidence intervals often without clear definitions. Across 9 studies, preference was reported as proportion, without definitions or comparators. Feasibility metric across 7 studies, was ill-defined and heterogeneously reported as either completion of strategy, or test procedure, often as a statistic without confidence intervals or a definition or a quantifiable metric. Impact measure (n = 13) was best quantified in clinical trials-reported as either time to treatment initiation, or time to receiving a test result, or change in numbers newly infected or screened with a POCT strategy. Unclear definitions of other IROs, lax measurement resulted in deficient documentation and weak quality ratings on STROBE and CONSORT checklists, raising concerns about the quality of the evidence presented.
Conclusion Poor reporting of IROs (i.e, feasibility, acceptability, preference) in POCT diagnostics masked evidence and pointed to the need for standardised definitions, quantification and reporting for them. A framework for documenting metrics beyond accuracy and impact is urgently needed to improve evaluation of true benefits of POCT diagnostics in implementation research.
- point of care diagnostics