Infectiepreventie op het OK-complex Module 1.2.1 Evidence-tabel
Table of quality assessment for systematic reviews of RCTs and observational studies (intervention studies)
|
Study First author, year |
Appropriateand clearly focused question? Yes/no/unclear |
Comprehensive and systematic literature search? Yes/no/unclear |
Description of included and excluded studies? Yes/no/unclear |
Description of relevant characteristics of included studies? Yes/no/unclear |
Appropriate adjustment for potential confounders in observational studies? Yes/no/unclear/ not applicable |
Assessment of scientific quality of included studies? Yes/no/unclear |
Enough Similarities between studies to make combining them reasonable? Yes/no/unclear |
Potential risk of publication bias taken into account? Yes/no/unclear |
Potential conflicts of interest reported? Yes/no/unclear |
|---|---|---|---|---|---|---|---|---|---|
|
Tanner, 2009 |
Yes |
Yes |
Yes |
Yes |
Not applicable |
Yes |
Yes |
No |
SR: no Individual studies: yes or unclear |
|
Mischke, 2014 |
Yes |
Yes |
Yes |
Yes |
Not applicable |
Yes |
Yes |
Yes |
SR: no Individual studies: yes or unclear |
|
Zhang, 2021 |
Yes |
Yes |
Yes |
Yes |
Not applicable |
Yes |
Yes |
Yes |
SR: no Individual studies: yes or unclear |
Evidence table for systematic review of RCTs and observational studies (intervention studies)
|
Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison (C) |
Follow-up |
Outcome measures and effect size |
Comments |
|---|---|---|---|---|---|---|---|
|
Tanner, 2009 |
SR and meta-analysis of RCTs Literature search up to June 2009 Studies1 A: Doyle, 1992 B: Gani, 1990 C: Jensen, 1997 D: Kovavisarach, 1998 E: Kovavisarach, 1999 F: Kovavisarach, 2002 G: Punyatanasakchai, 2004 H: Rudiman, 1999 I: Thomas, 2001 J: Wilson, 1996 Study design RCT Setting Hospital Country A: United Kingdom B: Australia C: China D: Thailand E: Thailand F: Thailand G: Thailand H: Indonesia I: India J: Oman Source of funding and conflicts of interest SR: Funding by Theatre Nurses Trust Fund, The University of Leeds, Derby Hospitals NHS Foundation Trust, and The National Association of Theatre Nurses; no conflicts of interest A: Not reported B: Not reported C: Gloves provided by manufacturer; conflicts of interest not reported D: Not reported E: Not reported F: Not reported G: Not reported H: Full text not available I: Not reported J: Not reported
|
Inclusion criteria SR 1) Randomized controlled trial, irrespective of language or publication status 2) Study includes any member of the surgical team (surgeon, second or assistant surgeon and scrub staff) practicing in a designated surgical theatre, in any surgical specialty, in any country 3) Study compares two or more glove types (single gloves, double gloves, glove liners, coloured perforation indicator systems, cloth outer gloves, steel outer gloves, triple gloves) 4) Study describes at least surgical site infections in surgical patients, glove perforations, or bloodborne infections in post- operative patients or the surgical team as an outcome 31 studies included by the authors, 20 of which compared single and double standard sterile surgical latex gloves. Of those, 10 were excluded from the meta-analysis to answer the search question - indicator inner glove as intervention (n=6) - vinyl inner glove as intervention (n=1) - orthopedic glove as comparator (n=1) - type of glove not reported (n=1) - insufficient data on number of gloves and glove perforations (n=1) N glove pairs A: 226 B: 1,317 C: 300 D: 1,029 E: 450 F: 252 G: 450 H: 180 I: 198 J: 384 Type of surgery A: Obstetrics and gynecology B: General C: Abdominal D: Obstetrics and gynecology E: Obstetrics and gynecology F: Obstetrics and gynecology G: Obstetrics and gynecology H: General I: General J: Multiple specialties Groups comparable at baseline? Not reported |
Intervention Double standard surgical latex glove |
Control Single standard surgical latex glove |
Endpoint of follow-up End of surgical procedure For how many glove pairs were no complete outcome data available? (n/N) A: 3/150 B: 15/233 C: Not reported D: Not reported E: Not reported F: Not reported G: Not reported H: 12/72 I: Not reported J: Not reported |
Inner glove pair perforations Effect measure: RR [95% CI]: A: 0.11 [0.03 to 0.34] B: 0.26 [0.17 to 0.40] C: 0.30 [0.17 to 0.54] D: 0.41 [0.24 to 0.68] E: 0.19 [0.06 to 0.63] F: 0.27 [0.11 to 0.68] G: 0.26 [0.12 to 0.58] H: 0.20 [0.06 to 0.66] I: 0.53 [0.27 to 1.04] J: 0.17 [0.07 to 0.40] Pooled effect (random effects model: 0.28 [0.22 to 0.36] favoring double gloves Heterogeneity (I2): 12% Outer glove pair perforations Effect measure: RR [95% CI]: A: 0.75 [0.46 to 1.23] B: 1.05[0.81 to 1.36] C: 1.18 [0.86 to 1.61] D: 0.88 [0.59 to 1.30] E: 1.25 [0.67 to 2.32] F: 0.86 [0.48 to 1.54] G: 1.26 [0.80 to 1.98] H: 0.80 [0.41 to 1.56] I: 1.16 [0.70 to 1.93] Pooled effect (random effects model): 1.03 [0.90 to 1.19] favoring single gloves Heterogeneity (I2): 0% |
Authors’ conclusions Wearing two pairs of latex surgical gloves is associated with significantly fewer inner glove perforations. There does not appear to be an increase in the number of outer glove perforations when two pairs of gloves are worn. Risk of bias Random sequence generation A, E, J: Definitely yes C, D, F, G, I: Unclear B, H: Definitely no Concealment of allocation E, C, I: Definitely yes A, B, D, F, G, H, J: Unclear Blinding of participants A - J: Definitely no Blinding of outcome assessor F: Definitely yes A, C, I, J: Unclear B, D, E, G, H: Definitely no Missing data infrequent A, B: Definitely yes C, D, E, F, G, I, J: Unclear H: Definitely no Free of selective reporting A - J: Definitely yes Other bias – free of CoI A, B, D, E, F, G, H, I, J: Unclear C: Probably no |
|
Mischke, 2014 |
SR and meta-analysis of RCTs Literature search up to September 2013 Studies2 A: Doyle, 1992 B: Gani, 1990 C: Jensen, 1997 D: Kovavisarach, 1998 E: Kovavisarach, 1999 F: Kovavisarach, 2002 G: Punyatanasakchai, 2004 H: Rudiman, 1999 I: Thomas, 2001 J: Wilson, 1996 Study design RCT Setting Hospital Country A: United Kingdom B: Australia C: China D: Thailand E: Thailand F: Thailand G: Thailand H: Indonesia I: India J: Oman Source of funding and conflicts of interest SR: No conflicts of interest A: Not reported B: Not reported C: Gloves provided by manufacturer; conflicts of interest not reported D: Not reported E: Not reported F: Not reported G: Not reported H: Full text not available I: Not reported J: Not reported
|
Inclusion criteria SR 1) Randomized controlled trial, irrespective of language, publication status or blinding 2) Study includes healthcare workers (at least 75% of study population) 3) Study compares the number of glove layers and/or special gloves 4) Study describes at least needlestick injury, sharps injury, blood stains inside the gloves or on the skin, glove perforations or dexterity as an outcome 34 studies included by the authors, 19 of which compared single and double standard sterile surgical latex gloves. Of those, 9 were excluded from the meta-analysis to answer the search question: - indicator inner glove as intervention (n=6) - vinyl inner glove as intervention (n=1) - orthopedic glove as comparator (n=1) - type of glove not reported (n=1) N glove pairs A: 226 B: 1,317 C: 300 D: 1,029 E: 450 F: 252 G: 450 H: 180 I: 198 J: 384 Type of surgery A: Obstetrics and gynecology B: General C: Abdominal D: Obstetrics and gynecology E: Obstetrics and gynecology F: Obstetrics and gynecology G: Obstetrics and gynecology H: General I: General J: Multiple specialties Groups comparable at baseline? Not reported |
Intervention Double standard surgical latex glove |
Control Single standard surgical latex glove |
Endpoint of follow-up End of surgical procedure For how many glove pairs were no complete outcome data available? (n/N) A: 3/150 B: 15/233 C: Not reported D: Not reported E: Not reported F: Not reported G: Not reported H: 12/72 I: Not reported J: Not reported |
Inner glove pair perforations Effect measure: RR [95% CI]: A: 0.11 [0.03 to 0.34] B: 0.26 [0.17 to 0.40] C: 0.30 [0.17 to 0.54] D: 0.41 [0.24 to 0.68] E: 0.19 [0.06 to 0.63] F: 0.27 [0.11 to 0.68] G: 0.26 [0.12 to 0.58] H: 0.20 [0.06 to 0.66] I: 0.53 [0.27 to 1.04] J: 0.17 [0.07 to 0.40] Pooled effect (random effects model): 0.28 [0.22 to 0.36] favoring double gloves Heterogeneity (I2): 12% Outer glove pair perforations Effect measure: RR [95% CI]: A: 0.75 [0.46 to 1.23] B: 1.05[0.81 to 1.36] C: 1.18 [0.86 to 1.61] D: 0.88 [0.59 to 1.30] E: 1.25 [0.67 to 2.32] F: 0.86 [0.48 to 1.54] G: 1.26 [0.80 to 1.98] H: 0.80 [0.41 to 1.56] I: 1.16 [0.70 to 1.93] Pooled effect (random effects model): 1.03 [0.90 to 1.19] favoring single gloves Heterogeneity (I2): 0% |
Authors’ conclusions There is moderate- quality evidence that double gloving compared to single gloving during surgery reduces perforations, indicating a decrease in percutaneous exposure incidents. There was moderate- quality evidence that double gloves have a similar number of outer glove perforations as single gloves, indicating that there is no loss of dexterity with double gloves. Risk of bias Random sequence generation A, E, J: Definitely yes C, D, F, G, I: Unclear B, H: Definitely no Concealment of allocation E, C, I: Definitely yes A, B, D, F, G, H, J: Unclear Blinding of participants A - J: Definitely no Blinding of outcome assessor F: Definitely yes A, C, I, J: Unclear B, D, E, G, H: Definitely no Missing data infrequent A, B: Definitely yes C, D, E, F, G, I, J: Unclear H: Definitely no Free of selective reporting A - J: Definitely yes Other bias – free of CoI A, B, D, E, F, G, H, I, J: Unclear C: Probably no |
|
Zhang, 2021 |
SR and meta-analysis of RCTs Literature search up to March 2020 Studies1 A: Guo, 2012 B: Kovavisarach, 1998 C: Kovavisarach, 1999 D: Kovavisarach, 2002 E: Makama, 2016 F: Punyatanasakchai, 2004 G: Thomas, 2001 Study design RCT Setting Hospital Country A: France B: Thailand C: Thailand D: Thailand E: Nigeria F: Thailand G: India Source of funding and conflicts of interest SR: No financial support; no conflicts of interest A: Funding by Hongkong Polytech University B: Not reported C: Not reported D: Not reported E: No funding; no conflicts of interest F: Not reported G: Not reported |
Inclusion criteria SR 1) Randomized controlled trial 2) Study includes surgical patients in the operating room (not surgical patients in clinical treating room or animals) 3) Study compares double gloving with single gloving (not indicator gloving system, special gloves or changing of gloves) 4) Study describes glove perforations as an outcome 5) Study is published in English N glove pairs A: 324 B: 1,029 C: 450 D: 252 E: 768 F: 450 G: 198 Type of surgery A: Multiple specialties (no orthopedics) B: Obstetrics and gynecology C: Obstetrics and gynecology D: Obstetrics and gynecology E: Multiple specialties (no orthopedics) F: Obstetrics and gynecology G: General Groups comparable at baseline? Not reported |
Intervention Double standard surgical latex glove |
Control Single standard surgical latex glove |
Endpoint of follow-up End of surgical procedure For how many glove pairs were no complete outcome data available? (intervention/control) A: Not reported B: not reported C: Not reported D: Not reported E: Not reported F: Not reported G: Not reported |
Inner glove pair perforations Effect measure: RR [95% CI]: A: 0.05 [0.00 to 0.85] B: 0.41 [0.24 to 0.68] C: 0.19 [0.06 to 0.63] D: 0.27 [0.11 to 0.68] E: 0.08 [0.03 to 0.17] F: 0.26 [0.12 to 0.58] G: 0.53 [0.27 to 1.04] Pooled effect (random effects model): 0.24 [0.13 to 0.43] favoring double gloves Heterogeneity (I2): 67% Outer glove pair perforations Effect measure: RR [95% CI]: A: 1.27 [0.57 to 2.81] B: 0.88 [0.59 to 1.30] C: 1.25 [0.67 to 2.32] D: 0.86 [0.48 to 1.54] E: 1.81 [1.46 to 2.24] F: 1.26 [0.80 to 1.98] G: 1.16 [0.70 to 1.93] Pooled effect (random effects model): 1.21 [0.93 to 1.59] favoring single gloves Heterogeneity (I2): 59% |
Authors’ conclusions Findings of this systematic review indicate that double gloving could reduce the rate of surgical glove perforation. Risk of bias Random sequence generation A, C: Definitely yes B, D, E, F, G: Unclear Concealment of allocation C, G: Definitely yes A, B, D, E, F: Unclear Blinding of participants A - G: Definitely no Blinding of outcome assessor D: Definitely yes E, G: Unclear A, B, C, F: Definitely no Missing data infrequent A - G: Unclear Free of selective reporting A - G: Definitely yes Other bias – free of CoI A - G: Unclear |
1 Ten of 31 studies were included in the meta-analysis to answer the search question of this module.
2 Ten of 34 studies were included in the meta-analysis to answer the search question of this module.