Cochrane · systematic review · MR000051
Monitoring strategies for clinical intervention studies
Klatte, K, Pauli-Magnus, C, Love, SB, et al. · Cochrane Database of Systematic Reviews · 2021 · Cochrane Library
MethodologyAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
20
current version
GRADE rated
10
No studies
10
Included studies
NR
No studies 10 · 50%Ungraded 0 · 0%Very low 5 · 25%Low 3 · 15%Moderate 2 · 10%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Questions and results
Risk‐based versus extensive on‐site monitoring
Population: clinical trials in all fields of health care
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Combined outcome of proportion of participants with major or critical monitoring findings Risk‐based vs extensive on‐site monitoring | RR 1.03 [0.8, 1.33] | 2 studies · 2377 participants | Moderate Downgraded: imprecision |
Impact of the monitoring strategy on participant on recruitment Risk‐based vs extensive on‐site monitoring | no estimate extracted | NR | No studies |
Impact of the monitoring strategy on Risk‐based vs extensive on‐site monitoring | no estimate extracted | NR | No studies |
Effect of the monitoring strategy on resource use Risk‐based vs extensive on‐site monitoring | no estimate extracted | NR | Low Downgraded: imprecision |
Central monitoring with triggered versus untriggered on‐site visits
Population: clinical trials in all fields of health care
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Sites ≥ 1 major monitoring finding combined outcome Central monitoring with triggered vs untriggered on‐site visits | RR 1.92 [0.4, 9.17] | 2 studies · 105 participants | Low Downgraded: imprecision |
Impact of the monitoring strategy on participant recruitment Central monitoring with triggered vs untriggered on‐site visits | no estimate extracted | NR | No studies |
Impact of the monitoring strategy on Central monitoring with triggered vs untriggered on‐site visits | no estimate extracted | NR | No studies |
Effect of the monitoring strategy on resource use Central monitoring with triggered vs untriggered on‐site visits | no estimate extracted | NR | No studies |
Central and local monitoring only versus central and local monitoring with on‐site visits
Population: clinical trials in all fields of health care
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Combined outcome of proportion of participants with major or critical monitoring findings Central and local monitoring only vs central and local monitoring with on‐site visits | OR 1.7 [1.1, 2.7] | 1 study · 4371 participants | Moderate Downgraded: imprecision, indirectness |
Impact of the monitoring strategy on participant recruitment Central and local monitoring only vs central and local monitoring with on‐site visits | no estimate extracted | NR | No studies |
Impact of the monitoring strategy on Central and local monitoring only vs central and local monitoring with on‐site visits | OR 0.8 [0.5, 1.1] | 1 study · 4371 participants | Very low Downgraded: imprecision, indirectness |
Effect of the monitoring strategy on resource use Cost attributed to on‐site monitoring (including visits for‐cause: 4 in on‐site group; 6 in the no on‐site group) Central and local monitoring only vs central and local monitoring with on‐site visits | no estimate extracted | NR | Very low Downgraded: imprecision, indirectness |
Remote or targeted source data verification versus 100% source data verification
Population: clinical trials in all fields of health care
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Monitoring findings Remote or targeted source data verification vs 100% source data verification | no estimate extracted | 1 study · 126 participants | Low Downgraded: risk of bias |
Impact of the monitoring strategy on participant recruitment Remote or targeted source data verification vs 100% source data verification | no estimate extracted | NR | No studies |
Impact of the monitoring strategy on Remote or targeted source data verification vs 100% source data verification | no estimate extracted | NR | No studies |
Effect of the monitoring strategy on resource use Remote or targeted source data verification vs 100% source data verification | no estimate extracted | 1 study · 126 participants | Very low Downgraded: imprecision |
Monitoring with versus without initiation visit
Population: clinical trials in all fields of health care
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Monitoring findings Monitoring with vs without initiation visit | no estimate extracted | NR | No studies |
Impact of the monitoring strategy on participant recruitment Difference in the number of recruited participants between groups visited vs non‐visited Monitoring with vs without initiation visit | no estimate extracted | 1 study · 573 participants | Very low Downgraded: imprecision, indirectness |
Impact of the monitoring strategy on Monitoring with vs without initiation visit | no estimate extracted | 1 study · 573 participants | Very low Downgraded: imprecision, indirectness |
Effect of the monitoring strategy on resource use Monitoring with vs without initiation visit | no estimate extracted | NR | No studies |