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. 2020 Dec 7;46(8):538–549. doi: 10.1097/BRS.0000000000003843

TABLE 3.

GRADE Evidence Summary of Findings for the Effect of PTED Versus Open Microdiscectomy

Quality Assessment No. of Patients
No. of Studies Design Limitations Inconsistency Indirectness Imprecision Other PTED OM Effect (95% CI) Quality of Evidence
Leg pain (intermediate term) 4 RCT Serious limitations No serious inconsistency No serious indirectness No serious imprecision No serious considerations 335 336 SMD 0.05 (–0.10 to 0.21) Moderate
Leg pain (long term) 3 RCT No serious limitations No serious inconsistency No serious indirectness Serious imprecision§ No serious considerations 100 112 SMD 0.11 (–0.30 to 0.53) Moderate
Functional outcome (intermediate term) 3 RCT Serious limitations No serious inconsistency No serious indirectness No serious imprecision No serious considerations 309 311 SMD –0.09 (–0.24 to 0.07) Moderate
Functional outcome (long term) 2 RCT No serious limitations No serious inconsistency No serious indirectness Serious imprecision§ No serious considerations 70 82 SMD –0.11 (–0.45 to 0.24) Moderate
Back pain (intermediate term) 1 RCT No serious limitations Serious inconsistency No serious indirectness Serious imprecision§ No serious considerations 61 60 SMD –0.04 (–0.39 to 0.32) Low
Back pain (long term) 1 RCT No serious limitations Serious inconsistency No serious indirectness Serious imprecision§ No serious considerations 52 62 SMD 0 (–0.37 to 0.37) Low
Complications|| 12 RCTProsp. Serious limitations No serious inconsistency No serious indirectness Serious imprecision§ Serious considerations 647 678 Not calculated Very low

Quality of evidence is downgraded if >50% of the study population origins of studies with a high or unclear risk of bias for allocation concealment.

Quality of evidence is downgraded if the I2 statistic >75% or if only one study reports on the outcome.

3 Quality of evidence is downgraded if study results are not generalizable.

§

Quality of evidence is downgraded if there are <400 patients in the study sample for continuous outcomes or if there are less than 300 events in the study sample for dichotomous outcomes.

Quality of evidence is downgraded if there are signs of publication bias or conflicts of interest.

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Dural tears, (transient) neurological deficits and wound infections were taken into this analysis.