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Table 3 Grading of the body of evidence for effectiveness of DOT versus SAT. Question: Does DOT result in higher initiation, adherence, or completion rates than SAT in individuals eligible for LTBI treatment?

From: Interventions for improving adherence to treatment for latent tuberculosis infection: a systematic review

  Quality assessment n/N = % Effect Quality Importance
No of studies (No of participants) Design Population treatment intervention Risk of bias Inconsistency Indirectness Imprecision Other considerations DOT OR (95 % CI) Absolutea (per 1000 (95 % CI))
SAT
Initiation
0 (0) No evidence available Critical
Adherence
0 (0) No evidence available Critical
Completion
1 (199) [17] RCT PWIDb long H Seriousc Not serious Not serious Not serious None 79/99 = 80 % 1.1 (0.5–2.1) 15 (−137-98) O Moderate Critical
Outreach DOT vs. SAT 79/100 = 79 %
1 (111) [16] RCT PWIDb long H Very seriousd Not serious Not serious Seriouse None 49/72 = 68 % 14.5 (5.0–42) 552 (296-732) OOO Very low Critical
DOT + Methadone treatment vs. SAT + no incentivef 5/39 = 13 %
1 (7731) [20] RCT Case contacts Very seriousg Not serious Not serious Not serious None 3273/3986 = 82 % 2.1 (1.9–2.3) 134 (119–146)  OO Low Critical
DOT + 3H + RPT vs. SAT + long H 2585/3745 = 69 %
1 (135) [54] RCT Immigrants long H Serioush Not serious Not serious Seriouse None 6/82 = 7.3 % 0.1 (0.04–0.3) −342 (−239- -387)  OO Low Critical
Clinic-based DOTi vs. SAT dailyc 22/53 = 41 %
  1. Bibliography: Chaisson et al. 2001 [17]; Batki et al. 2002 [16]; Sterling et al. 2011 [20]; Matteelli et al. 2000 [54]
  2. n/N No of individuals with LTBI who initiated, or adhered to or completed treatment/total number of subjects; CI confidence interval; DOT directly observed therapy; H, 3H (3 months) isoniazid; OR odds ratio; PWID people who inject drugs; RCT randomized controlled trial; RPT rifapentine; SAT self-administered therapy
  3. aCalculated via GradePro
  4. bBoth studies with PWID population are presented separately, since one of the studies applies DOT + an incentive as intervention
  5. cChaisson et al. 2001 [17]: unclear allocation concealment; no blinding; use of unvalidated patient-reported outcomes in SAT arm (self-report; urine tests and MEMS in a subset of patients in this study show that self-reported adherence was greatly overestimated, thereby possibly underestimating the effect of DOT)
  6. dBatki et al. 2002 [16]: no blinding; use of unvalidated patient-reported outcomes in SAT arm (monthly medication pick-up); dissimilarities between treatment arms (age, Addiction Severity Index psychiatric and Beck depression inventory); exposure bias (incentive in DOT arm)
  7. etotal number of events <125
  8. fApproximately half of the intervention group (37/72) also received substance abuse counselling
  9. gSterling et al. 2011 [20]: unclear allocation concealment; no blinding; use of unvalidated patient-reported outcomes in SAT arm (pill count and self-report); dissimilarities between treatment arms (with respect to North American Indians, subjects enrolled in a cluster, homelessness); exposure bias (short treatment in DOT arm)
  10. hMatteelli et al. 2000 [54]: unclear allocation concealment; no blinding; very large loss to follow-up; unclear treatment adherence assessment in SAT arm; unequal numbers in treatment arms; early termination (due to low completion rates in DOT arm). Early termination partially accounts for the low numbers in this study, and as we already downgraded for this (serious imprecision), we decided not to downgrade for it again in the risk of bias
  11. iMost likely DOT, however terminology not very clear in the methods and results sections of the article