van Kampen 2015.
| Study characteristics | ||
| Methods | Before‐and‐after implementation study | |
| Participants | Criteria: individuals at high risk of MDR‐TB according to guidelines, March 2011 to March 2013 All age groups Female: pre 40%, post 38% HIV: pre 0.8%, post 2.9% Setting: three clinics offering programmatic management of drug resistant tuberculosis in East, Central, and West Java in Indonesia Country: Indonesia Number of eligible participants: pre 871, post 966 |
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| Interventions | The diagnostic approach in the before period was to collect one sputum sample from each individual, and conduct smear microscopy and culture on solid or liquid media. If the culture was positive for tuberculosis, an isolate was re‐cultured for first‐line DST. During the intervention, one sputum sample was collected for Xpert testing and a second sample was used for diagnostic workup with culture and first‐line DST | |
| Outcomes | Proportion of individuals positive for tuberculosis Second‐line treatment initiation in participants with rifampicin‐resistant tuberculosis Time from client registration to diagnosis Time from diagnosis to treatment start |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | A pre‐post study without randomization |
| Allocation concealment (selection bias) | High risk | A pre‐post study where allocation of intervention was not concealed, allocation was determined by calender period |
| Baseline characteristics similar (selection bias) | Unclear risk | participant characteristics were reported; no substantial differences were observed. However, a higher rate of testing occurred after the introduction of Xpert MTB/RIF. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
| Protection against contamination (performance bias) | High risk | Some participants were tested using conventional methods during the intervention period |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding was done, and could not have been achieved |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data were reported; there were no differences between before and after |
| Selective reporting (reporting bias) | Low risk | Outcomes stated in the methods were reported |
| Other bias | High risk | Risk of confounding due to pre‐post design |