Clinical effectiveness and safety of self-expandable implantable bulking agents for faecal incontinence: a systematic review

Table 4 GRADE evidence profile: Clinical effectiveness and safety of implantable bulking agents in patients with faecal incontinence

Quality assessment
Number of studies (patients)	Study design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Impact	Certainty (Importance)
Clinical effectiveness
Due to the lack of a controlled group, no data on clinical effectiveness outcomes can be compared and synthesised
Safety
Procedure-related adverse events (FU: range 1 month to 36 months)
8 (166 pts)	Single-arm, before-after study	Very serious^a	Not serious	Not serious	Not serious	None	In 16 of 166 analysed pts Intraoperative complications: n = 4 Postoperative complications/morbidity: n = 0 Infection/sepsis/inflammation: n = 0 Anal discomfort/pain, analgesia > 48 h: n = 12 Adverse effect/reaction/general complication: n = 0	⊕◯◯◯ VERY LOW (crucial)
Device-related adverse events (FU: range 1 month to 36 months)
8 (166 pts)	Single-arm, before-after study	Very serious^a	Not serious	Not serious	Not serious	None	In 48 of 166 analysed pts Dislodgement of prostheses: n = 41 Prosthesis removed/extruded: n = 7	⊕◯◯◯ VERY LOW (crucial)

FU follow-up, GRADE Grading of Recommendations, Assessment, Development and Evaluations, pts patients
Nomenclature for GRADE table:
Limitations: 0: no limitations or no serious limitations; − 1: serious limitations
Inconsistency: NA: Not applicable (only one trial); 0: no important inconsistency; − 1: important inconsistency
Indirectness: 0: direct, no uncertainty, − 1: some uncertainty, − 2 major uncertainty
Other modifying factors: publication bias likely (− 1), imprecise data (− 1), strong or very strong association (+ 1 or + 2), dose–response gradient (+ 1), Plausible confounding (+ 1)
^aUsing the IHE risk of bias checklist, three studies were rated with moderate and three studies with a high risk of bias (Additional file 1). Very serious limitations are given due to the lack of controlled study designs

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