Design-specific criteria to assess methodological quality
| Categories | Domains | |||
| 1. Patient selection | 2. IT | 3. RS | 4. Flow and timing | |
| Description | Briefly describe the methods of patient selection: | Describe the IT (HAND), how it was conducted and interpreted: | Describe the RS (STAND) how it was conducted and interpreted: | Describe patients that did not receive HAND, and/or STAND or who were excluded from the 2×2 table. Describe the time interval and any interventions between the HAND and STAND. |
| Indicator questions (yes, no, unclear) | Was a consecutive or random sample of patients enrolled? | Were the HAND results interpreted without knowledge of the results of STAND? | Was STAND likely to correctly classify the target condition? | Was there an appropriate time interval between HAND and STAND? |
| Was a case–control design avoided? | Was a prespecified threshold used? | Were the STAND results interpreted without knowledge of the HAND results? | Did all patients receive STAND and was it the same RS? | |
| Did the study avoid inappropriate exclusions? | Were all patients included in the analysis? | |||
| *Risk of bias (low, high, unclear) | Based on the indicator questions, could the selection of patients have introduced bias? | Based on the indicator questions, could the conduct or interpretation of HAND have introduced bias? | Based on the indicator questions, could STAND, its conduct or its interpretation have introduced bias? | Based on the indicator questions, could the patient flow and timing have introduced bias? |
| Concerns Regarding Applicability (low, high, unclear) | Describe included patients (prior testing, presentation, intended use of HAND and setting): Based on the description of included patients, are there concerns that the included patients do not match the review question? | Are there concerns that HAND, its conduct, or interpretation differ from the review question? | Are there concerns that the target condition as defined by STAND does not match the review question? | |
*Criteria for grading risk of bias: If all indicator questions for a single domain are answered ‘ yes’, then the risk of bias will be judged as being ‘ low’; if any indicator question is answered ‘ no’, then the potential for bias will be flagged and the review authors will be required to judge the risk of bias with the assistance of the senior author (MEE); if all or most indicator questions were answered ‘ no’, then the risk of bias will be judged as being ‘ high’ and indicator questions are can only be answered as ‘unclear’ when the data are insufficient to allow for the formulation of a judgement.
Adapted from Whiting et al.11
IT, index test; RS, reference standard.