Risk of bias for analysis 2.8 Adverse events: electrode/lead failure or displacement. Long‐term follow‐up.

Study

Bias

Randomisation process

Deviations from intended interventions

Missing outcome data

Measurement of the outcome

Selection of the reported results

Overall

Authors' judgement

Support for judgement

Authors' judgement

Support for judgement

Authors' judgement

Support for judgement

Authors' judgement

Support for judgement

Authors' judgement

Support for judgement

Authors' judgement

Support for judgement

Kemler 2000

Low risk of bias

Computer generated randomisation. Allocation concealed. Minor imbalance of gender (61%F in SCS group and 83%F in PT group) but compatible with chance.

Low risk of bias

Open label study without blinding of participants and personnel and no information provided to assess deviations in the PT management across groups. Any potential deviations in PT management unlikely to impact the incidence of device related adverse events.

High risk of bias

At 5 year follow up, 14% LTFU in SCS group and 28% LTFU in PT group. It is possible that LTFU was related to adverse events.

High risk of bias

Limited information on how AEs were classified and the approach taken to surveillance which may impact on the reported values.

Some concerns

No triap protocol or SAP available

High risk of bias

High risk of bias on multiple domains.