Antibiotic regimens for postpartum endometritis

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Barza 1996 performed a meta-analysis of single versus multiple doses of aminoglycoside for the treatment of various infections, and the conclusions support a once-daily regimen.

“Barza 1996 performed a meta-analysis of single versus multiple doses of aminoglycoside for the treatment of various infections, and the conclusions support a once-daily regimen.”

• cites Barza 1996 sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Thirty studies identified in the search were excluded from the analysis.

“We excluded 30 studies identified in the search from the analysis for the following reasons:”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The review includes 42 trials, of which 40 contributed data on 4240 participants.

“The review includes a total of 42 trials, and 40 of these trials contributed data on 4240 participants.”

• Also stated in: § Results of the search · plain

  “We identified 72 trials.We included 42 (40 of these trials contributed data on 4240 participants), and excluded 30.”

May combine two claims.

Twenty studies enrolled only postpartum women who developed endometritis after cesarean birth; in four studies, the mode of delivery was not reported.

“Twenty studies enrolled only postpartum women who developed endometritis a er cesarean birth; in four studies, the mode of delivery was not reported.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Although women who developed endometritis during the first six weeks postpartum were eligible, the vast majority appeared to have been enrolled within 48 hours of birth.

“Although women who developed endometritis during the first six weeks of the postpartum period were eligible for inclusion in this review, the vast majority appeared to have been enrolled within 48 hours of birth.”

May combine two claims.

There was no funnel plot asymmetry found in Analysis 1.1, Analysis 1.2, Analysis 1.4, Analysis 1.5, or Analysis 3.1.

“There was no funnel plot asymmetry found in the following analyses: Analysis 1.1; Analysis 1.2; Analysis 1.4; Analysis 1.5; Analysis 3.1 (Figure 3; Figure 4; Figure 5; Figure 6; Figure 7).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

All but seven studies were conducted in the United States; one was conducted in France, two in Mexico, and one each in Italy, Peru, and Colombia; one study was multicenter.

“All, but seven studies were conducted in the United States: one was conducted in France, two in Mexico, and one each in Italy, Peru, and Colombia.One study was a multicenter study conducted in many countries, including the United States.”

The quote only partly states this claim.

There was no difference between aztreonam plus clindamycin and other regimens for any of the outcomes (Analysis 4.1; Analysis 4.2; Analysis 4.3; Analysis 4.4; Analysis 4.5; Analysis 4.6).

“There was no difference between these regimens for any of the outcomes (Analysis 4.1; Analysis 4.2).”

• Also stated in: § Secondary outcomes · plain

  “There was no difference between these regimens for any of the outcomes (Analysis 4.3; Analysis 4.4; Analysis 4.5; Analysis 4.6).”

May combine two claims.

Gentamicin plus ampicillin versus piperacillin/tazobactam showed no significant differences in treatment failures (RR 0.56, 95% CI 0.15 to 2.03; 56 participants, Analysis 2.1.2) or wound infection (RR 2.44, 95% CI 0.13 to 44.57; 56 participants; 1 study, Analysis 2.3.2).

“There were no significant differences in treatment failures (RR 0.56, 95% CI 0.15 to 2.03; 56 participants, Analysis 2.1.2) or wound infection (RR 2.44, 95% CI 0.13 to 44.57; 56 participants; 1 study, Analysis 2.3.2) when comparing gentamicin plus ampicillin versus piperacillin/tazobactam.”

May combine two claims.

There were no significant differences in wound infections, allergic reactions, or diarrhea for gentamicin/penicillin versus gentamicin/clindamycin.

“There were no significant differences in wound infections (RR 0.50, 95% CI 0.22 to 1.12; 200 participants; 1 study, Analysis 2.3.1),allergic reactions (RR 1.00, 95% CI 0.14 to 6.96; 200 participants; 1 study, Analysis 2.4.1) or diarrhea (RR 5.00, 95% CI 0.24 to 102.85; 200 participants; 1 study, Analysis 2.5.1).”

The quote only partly states this claim.

There were no statistically significant differences for any other outcome for beta-lactam/beta-lactamase inhibitor combination versus another regimen (Analysis 3.3; Analysis 3.4; Analysis 3.5; Analysis 3.6).

“There were no statistically significant differences for any other outcome (Analysis 3.3; Analysis 3.4; Analysis 3.5; Analysis 3.6).”

May combine two claims. The quote only partly states this claim.

No differences were found in treatment failure, severe complications, wound infection, urinary tract infection, recurrence of endometritis, or length of stay for continued oral antibiotic therapy versus no treatment after intravenous therapy.

“No differences were found in treatment failure (Analysis 8.1).There were no severe complications in the studies (Analysis 8.2).”

• Also stated in: § Secondary outcomes · plain

  “No differences were found in wound infection (Analysis 8.3), urinary tract infection (Analysis 8.4), recurrence of endometritis (Analysis 8.5), or length of stay (Analysis 8.6).”

The quote only partly states this claim.

There was no difference in the incidence of nephrotoxicity between once-daily and thrice-daily gentamicin regimens (Analysis 7.2).

“There was no difference in the incidence of nephrotoxicity between regimens (Analysis 7.2).”

May combine two claims.

No study looked at the effect of treatment on the infant of a breastfeeding mother, and maternal renal toxicity was not described systematically.

“No study looked at the effect of treatment on the infant of a breastfeeding mother and any maternal renal toxicity was not described systematically.”

Probably not a substantial claim: may not pass S4 (based). May combine two claims.

The majority of these studies took a traditional approach to the treatment of endometritis and compared new regimens to the standard of care in North America.

“The majority of these studies took a traditional approach to the treatment of endometritis and compared new regimens to the standard of care in North America.”

• AssumptionRests on an assumption: The standard of care in North America for endometritis is clindamycin plus gentamicin.

May combine two claims.

Very rarely were drug costs collected and overall no attempt was made to collect and compare all costs of treatment, including length of stay.

“Very rarely were drug costs collected and overall no attempt was made to collect and compare all costs of treatment, including length of stay.”

Probably not a substantial claim: may not pass S3 (load-bearing). The quote only partly states this claim.

No secondary outcomes were reported for the comparison of oral ofloxacin/clindamycin versus intravenous clindamycin/gentamicin.

“No secondary outcomes were reported.”

May combine two claims.

Regimens with poor activity against penicillin-resistant anaerobic bacteria had higher failure rates and more wound infections than regimens with good activity against these organisms.

“Regimens with poor activity against penicillin-resistant anaerobic bacteria had higher failure rates and more wound infections than regimens with good activity against these organisms.”

The quote only partly states this claim.

Oral ofloxacin/clindamycin versus intravenous clindamycin/gentamicin showed no significant differences for treatment failures (RR 0.67, 95% CI 0.15 to 2.98; I 0%, Analysis 10.1).

“Primary outcomes showed no significant differences for treatment failures (RR 0.67, 95% CI 0.15 to 2.98; I 0%, Analysis 10.1).”

The quote only partly states this claim.

No significant differences were found for other outcomes for longer half-life versus shorter half-life agents (Analysis 5.3; Analysis 5.4; Analysis 5.5; Analysis 5.6).

“No significant differences were found for the other outcomes (Analysis 5.3; Analysis 5.4; Analysis 5.5; Analysis 5.6).”

Probably not a substantial claim: may not pass S4 (based). May combine two claims.

Very few studies have been conducted outside of the USA, with only four studies (from Central and South America) performed in the developing world.

“Very few studies have been conducted outside of the USA, with only four studies (from Central and South America) performed in the developing world.”

The quote only partly states this claim.

In women with postpartum endometritis, regimens with poor activity against penicillin-resistant anaerobic bacteria do not differ from regimens with good activity in severe complication (RR 1.68, 95% CI 0.45 to 6.29; 5 studies, 671 women).

“Total (95% CI) 364 307 100% 1.68[0.45,6.29]Total events: 5 (Poor anaerobic tx), 2 (Good anaerobic tx)”

Probably not a substantial claim: may not pass S3 (load-bearing).

In the comparison of penicillin plus beta-lactamase inhibitor versus penicillin, the risk ratio for diarrhea was 0.0 (95% CI 0.0 to 0.0) in 1 study with 56 participants.

“5.3 Penicillin plus beta-lactamase inhibitor versus penicillin 1 56 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]”

May combine two claims.

In one trial (Pietrantoni 1998) of 16 participants, oral ofloxacin plus intravenous clindamycin compared with intravenous clindamycin plus gentamicin had a risk ratio for treatment failure of 0.67 (95% CI 0.15 to 2.98), with 2/8 versus 3/8 events, and the overall effect was not statistically significant (Z=0.53, P=0.6).

“Pietrantoni 1998 2/8 3/8 100% 0.67[0.15,2.98]Total (95% CI) 8 8 100% 0.67[0.15,2.98]Total events: 2 (Oral ofloxacin+ IV clinda), 3 (IV clinda/gent) Heterogeneity: Not applicable Test for overall effect: Z=0.53(P=0.6)”

• cites Pietrantoni 1998 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

The clinical criteria listed to define endometritis were consistent across trials.

“The clinical criteria listed to define endometritis were consistent across trials.”

May combine two claims.

Only one study had its protocol available, and all of the prespecified outcomes were reported (Del Priore 1996); most study protocols were not available and therefore risk of bias was judged to be unclear due to insufficient information.

“Only one study had its protocol available, and all of the prespecified outcomes were reported (Del Priore 1996).Most of the study protocols were not available and therefore risk of bias was judged to be unclear, due to insufficient information.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Three studies were described as single-blind, and in most trials there was no description of blinding.

“Three studies were described as 'single-blind'.In most trials there was no description of blinding.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Studies were excluded from the analysis when more than 20% of participants dropped out or were excluded after randomization.

“We excluded studies from the analysis when more than 20% of participants dropped out or were excluded a er randomization.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

A sensitivity analysis incorporating allocation concealment was not performed because in all but five studies treatment allocation was inadequately described.

“Given that in all but five of the studies, treatment allocation was inadequately described, we did not perform a sensitivity analysis incorporating allocation concealment as a measure of study quality as this was not appropriate.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Two review authors independently assessed risk of bias for each study using Cochrane Handbook criteria; disagreements were resolved by discussion or by involving a third assessor.

“Two review authors independently assessed risk of bias for each study using the criteria outlined in theCochrane Handbook for Systematic Reviews of Interventions ( Higgins 2011 ).We resolved any disagreement by discussion or by involving a third assessor.”

• cites Higgins 2011Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim.

To reduce the likelihood of bias, studies in which more than 20% of participants had dropped out or been excluded from the analysis after randomization were excluded.

“To reduce the likelihood of bias, we excluded studies in which more than 20% of participants had dropped out or been excluded form the analysis a er randomization.”

May combine two claims.

The numbers of women studied were often small and data on other outcomes were limited.

“the numbers of women studied were o en small and data on other outcomes were limited”

Classified as probably not a substantial claim. May combine two claims.

Analyses were carried out on an intention-to-treat basis, including all participants randomized in the groups to which they were allocated.

“For all outcomes, we carried out analyses, as far as possible, on an intention-to-treat basis, that is, we attempted to include all participants randomized to each group in the analyses, and all participants were analyzed in the group to which they were allocated, regardless of whether or not they received the allocated intervention.”

Classified as probably not a substantial claim.

Because in all but five studies treatment allocation was inadequately described, a sensitivity analysis incorporating allocation concealment as a measure of study quality was not performed.

“Given that in all but five of the studies, treatment allocation was inadequately described, we did not perform a sensitivity analysis incorporating allocation concealment as a measure of study quality as this was not appropriate.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Two review authors independently assessed all potential additional studies for inclusion; disagreements were resolved by discussion or by consulting a third person.

“Two review authors independently assessed all the potential additional studies we identified as a result of the search strategy for inclusion.We resolved any disagreement through discussion or, if required, we consulted a third person.”

May combine two claims.

Pharmaceutical sponsorship was evident in 18 studies, which were therefore judged as being at high risk of bias.

“Pharmaceutical sponsorship was evident in 18 studies, which were therefore judged as being at high risk of bias.”

May combine two claims.

When drop-outs were reported, the reasons why women who had initially been randomized were eventually excluded from the analysis were usually explained, but frequently the number corresponding to each arm of the study was not given.

“When drop-outs were reported, the reasons why women who had initially been randomized were eventually excluded from the analysis were usually explained.Frequently, however, the number corresponding to each arm of the study was not given.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Blinding was described in only a few studies.

“Blinding was described in only a few studies.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Although many studies reported that a computerized randomization schedule was used, it was unclear how the randomization schedule was actually administered.

“Although many of these studies did report that a computerized randomization schedule was used, it was unclear how the randomization schedule was actually administered.”

May combine two claims.

Eight studies were judged to have an unclear additional bias; three studies had truncated versions of the original publication only partially translated; three studies were suspected to have pharmaceutical sponsorship not overtly reported; one study had only an abstract available; and one study published what appeared to be preliminary data.

“We judged eight studies to have an unclear additional bias.For three studies we had truncated versions of the original publication that were only partially translated from the initial language (Figueroa-Damian 1996;Gutierrez 1994;Rodriguez 1996).We suspected that three studies had pharmaceutical sponsorship, but this was not overtly reported (Apuzzio 1985a;Apuzzio 1985b;Hemsell 1983).One study had”

Probably not a substantial claim: may not pass S3 (load-bearing).

A positive microbiological diagnosis was rarely required for the diagnosis of either wound infection or endometritis.

“A positive microbiological diagnosis was rarely required for the diagnosis of either wound infection or endometritis.”

Classified as probably not a substantial claim. May combine two claims.

The review included randomized trials of different antibiotic regimens after cesarean or vaginal birth; no quasi-randomized trials were included.

“We included randomized trials of different antibiotic regimens a er cesarean birth or vaginal birth; no quasi-randomized trials were included.”

May combine two claims.

In women who developed endometritis postcesarean birth there was no consistent approach to the use of prophylactic antibiotics; four studies excluded women who had received prophylaxis, while five others stated that all women had received prophylaxis.

“In women who developed endometritis postcesarean birth there was no consistent approach to the use of prophylactic antibiotics.While four studies excluded women who had received prophylaxis, five others stated that all women had received prophylaxis.”

May combine two claims.

Only four studies used placebo doses; nine studies reported a double-blind design, but only three described how they attempted to ensure the medications appeared similar in appearance.

“Only four studies used placebo doses and, although nine studies reported a 'double-blind' design, only three studies described how they attempted to ensure the medications appeared similar in appearance (Gibbs 1982;Gibbs 1983;Hillier 1990).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.

“Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Febrile morbidity is a standard obstetrical outcome and was generally consistently reported, although there was some variation in the exact criteria used.

“Febrile morbidity is a standard obstetrical outcome and was generally consistently reported, although there was some variation in the exact criteria used for height of fever, interval between febrile episodes and interval from the operative procedure.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Two review authors abstracted data using an agreed form; discrepancies were resolved by discussion or by consulting a third person; data were entered into Review Manager and checked for accuracy.

“For eligible studies, two review authors abstracted the data using the agreed form.We resolved discrepancies through discussion or, if required, we consulted a third person.We entered data into Review Manager so ware and checked for accuracy (RevMan 2014).”

• cites RevMan 2014Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

The spectrum of activity of clindamycin with gentamicin makes these antibiotics a popular choice for initial therapy and this combination is widely considered as the gold standard.

“The spectrum of activity of clindamycin with gentamicin makes these antibiotics a popular choice for initial therapy and this combination is widely considered as the gold standard (Monga 1993).”

• cites Monga 1993Not checked — no full text of the source

Classified as probably not a substantial claim.

The GRADE approach was used to assess the quality of the body of evidence for primary and secondary outcomes for the main comparison.

“For this update we used the GRADE approach as outlined in the GRADE handbook in order to assess the quality of the body of evidence relating to the following primary and secondary outcomes for the main comparison (i.e.clindamycin plus aminoglycoside versus cephalosporins or penicillins): 1. treatment failures; 2. severe complications (including pelvic abscess and septic pelvic vein thrombophlebiti”

Probably not a substantial claim: may not pass S3 (load-bearing).

One other study stated that interventions were similar in appearance without describing how this was accomplished (MacGregor 1992).

“One other study stated that interventions were similar in appearance without describing how this was accomplished (MacGregor 1992).”

Probably not a substantial claim: may not pass S3 (load-bearing).

There was no consistent approach to the definition of serious morbidity.

“There was no consistent approach to the definition of serious morbidity.”

May combine two claims.

The combination of intravenous gentamicin and clindamycin, and drugs with a broad range of activity against relevant penicillin-resistant bacterial strains, are the most effective for treating endometritis after childbirth.

“The results showed that the combination of intravenous gentamicin and clindamycin, and drugs with a broad range of activity against the relevant penicillin-resistant bacterial strains, are the most effective for treating endometritis a er childbirth.”

• AssumptionRests on an assumption: Endometritis is usually a polymicrobial infection associated with mixed aerobic and anaerobic flora.

Probably not a substantial claim: may not pass S3 (load-bearing).

Reporting biases were investigated using funnel plots because there were more than 10 studies in the meta-analysis.

“As there are more than 10 studies in the meta-analysis we investigated reporting biases (such as publication bias) using funnel plots.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

No language or date restrictions were applied in the search.

“We did not apply any language or date restrictions.”

May combine two claims.

We downgraded scores as most studies had design limitations, few events, and wide confidence intervals crossing the line of no effect.

“We downgraded scores as most studies had design limitations, few events, and wide confidence intervals crossing the line of no effect.”

Classified as probably not a substantial claim.

For this reason we have provided analysis of available cases rather than intention-to-treat.

“For this reason we have provided analysis of available cases (rather than intention-to-treat).”

May combine two claims.

In Chatwani 1997, incomplete outcome data was at high risk of attrition bias; 49 women from the trospectomycin group and 45 from the clindamycin group (about 30%) were excluded from the efficacy evaluation.

“Forty-nine patients from the trospectomycin group and 45 from the clindamycin group were excluded for the efficacy evaluation.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Faro 1989, random sequence generation was at low risk of selection bias because a computer-generated randomisation schedule was provided by Miles Pharmaceuticals.

“a computer-generated randomisation schedule provided by Miles Pharmaceuticals.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Fernandez 1990, other bias was at low risk because the study appeared free of other sources of bias.

“Study appeared to be free of other sources of bias”

May combine two claims.

Despite potential biases, which would most likely work against the control arm, the combination of clindamycin and an aminoglycoside was more effective than other regimens with fewer treatment failures and wound infections.

“But despite all these potential biases, which would most likely work against the control arm, the combination of clindamycin and an aminoglycoside was more effective than other regimens with fewer treatment failures and wound infections.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Fernandez 1990, random sequence generation was at low risk of selection bias because random-number tables were used.

“Random-number tables”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Del Priore 1996, other bias was at low risk because the study appeared free of other sources of bias.

“Study appeared to be free of other sources of bias”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Del Priore 1996, incomplete outcome data was at low risk of attrition bias; of 142 randomized subjects, 15 were excluded for protocol violations and 127 remained for analysis (about 89% of data available).

“A total of 142 subjects were randomized.Fifteen were excluded from analysis because of study-protocol violations”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Figueroa-Damian 1996, allocation concealment was at low risk of selection bias because the randomization code was prepared by the Upjohn Company and carried out by the hospital pharmacy.

“Randomization code was prepared by the Upjohn (pharmaceutical) Company and was carried out by the (hospital) pharmacy.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In DiZerega 1979, other bias was at low risk because the study appeared free of other sources of bias.

“Study appeared to be free of other sources of bias”

Classified as probably not a substantial claim. May combine two claims.

We tried to minimize potential biases in the review process by having at least two review authors independently assess the eligibility for inclusion and exclusion, perform data abstraction and assess the risk of bias.

“We tried to minimize potential biases in the review process by having at least two review authors independently assess the eligibility for inclusion and exclusion, perform data abstraction and assess the risk of bias.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Figueroa-Damian 1996, blinding of outcome assessment was at low risk of detection bias because the study was described as a small double blind study.

“undertook a small double blind study”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Since postpartum endometritis is an important cause of maternal morbidity and mortality in low-income countries, the lack of studies conducted in such environments leaves a gap in our knowledge.

“Since postpartum endometritis is an important cause of maternal morbidity and mortality in low-income countries, the lack of studies conducted in such environments leaves a gap in our knowledge.”

• AssumptionRests on an assumption: Postpartum endometritis is an important cause of maternal morbidity and mortality in low-income countries.

Probably not a substantial claim: may not pass S3 (load-bearing).

In Chatwani 1997, random sequence generation was at low risk of selection bias because a computer-generated randomization table was provided by the pharmaceutical sponsor.

“Computer-generated randomization table by pharmaceutical sponsor”

May combine two claims.

There were opportunities for systematic bias: allocation concealment was usually inadequately described and only rarely was there any attempt at blinding.

“There were opportunities for systematic bias: allocation concealment was usually inadequately described and only rarely was there any attempt at 'blinding'.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Many of the studies performed extensive bacteriological work-up on endometrial cultures, but this could not be approached systematically nor incorporated into this review.

“Many of the studies performed extensive bacteriological work-up on endometrial cultures, but this could not be approached systematically nor incorporated into this review.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Chatwani 1995, incomplete outcome data was at low risk of attrition bias; 382 women were initially enrolled and 377 who received medication were evaluated for safety, with a further 22 women excluded by a protocol change.

“382 women initially enrolled, 377 women received medication were evaluated for safety.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Del Priore 1996, random sequence generation was at low risk of selection bias because a computer-generated random numbers table was used via sealed envelopes.

“Computer-generated random numbers table via sealed envelopes”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Chatwani 1995, random sequence generation was at low risk of selection bias because a computer-generated randomization table was provided by the pharmaceutical sponsor.

“Computer-generated randomization table provided by pharmaceutical sponsor”

Classified as probably not a substantial claim. May combine two claims.

No specific recommendations can be made for the treatment of women who develop endometritis after receiving antibiotic prophylaxis for cesarean birth because that population could not be specifically studied in this review.

“No specific recommendations can be made for the treatment of women who develop endometritis a er receiving antibiotic prophylaxis for cesarean birth as we were unable to specifically study that population in this review.”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Figueroa-Damian 1996, blinding of participants and personnel was at low risk of performance bias because the hospital pharmacy dispensed antibiotics to the floor in a double blind fashion.

“The hospital pharmacy dispensed [antibiotics] to the floor in a double blind fashion.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Faro 1989, incomplete outcome data was at low risk of attrition bias; 18 women (10.6%) were excluded after enrolment for protocol violations, balanced between arms.

“18 women (10.6%) were excluded after enrolment for protocol violations”

May combine two claims.

For many comparisons the numbers studied were small and, although unlikely, significant differences may not have been detected.

“However, for many of these comparisons the numbers studied were small and, although unlikely, significant differences may not have been detected.”

May combine two claims.

None of the trials' regimens included ampicillin plus clindamycin plus an aminoglycoside, so a recommendation cannot be made as to whether these three antibiotics are superior to clindamycin plus gentamicin alone.

“Also, it should be noted that none of the trials' regimens included ampicillin plus clindamycin plus an aminoglycoside, so we cannot make a recommendation as to whether these three antibiotics are superior to clindamycin plus gentamicin alone.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Chatwani 1997, other bias was at high risk because of explicit pharmaceutical sponsorship.

“Pharmaceutical sponsorship -explicit”

Probably not a substantial claim: may not pass S3 (load-bearing).

In DiZerega 1979, incomplete outcome data was at low risk of attrition bias because there were no drop-outs.

“Drop-outs -none”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Del Priore 1996, selective reporting was at low risk of reporting bias because the protocol was available and all pre-specified outcomes were reported.

“Protocol available and all of the study's pre-specified outcomes have been reported”

Classified as probably not a substantial claim. May combine two claims.

Many of the studies date back to the 1970s and 1980s; since then there may have been changes in the causative organisms, as well as in the antimicrobial resistance profile.

“Many of the studies date back to the 1970s and 1980s.Since then there may have been changes in the causative organisms, as well as in the antimicrobial resistance profile.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Del Priore 1996, allocation concealment was at low risk of selection bias because sealed opaque envelopes were used.

“Used sealed opaque envelopes”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Fernandez 1990, incomplete outcome data was at low risk of attrition bias because drop-outs were less than 5%.

“Drop-outs < 5%”

May combine two claims.

Though drop-outs were reported with reasons explained, frequently the number corresponding to each arm of a study was not given.

“Though drop-outs were reported with reasons explained, frequently, the number corresponding to each arm of a study was not given.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Often the study was sponsored by the manufacturer of a new drug and this drug was compared with the control regimen, typically clindamycin plus gentamicin.

“O en the study was sponsored by the manufacturer of a new drug and this drug was compared with the control regimen, typically clindamycin plus gentamicin.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Chatwani 1995, other bias was at high risk because the study was sponsored by the pharmaceutical company Upjohn.

“Sponsored by pharmaceutical company, the Upjohn company”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Hager 1989, random sequence generation was at low risk of bias because a computer-generated random sequence was used.

“Random sequence generation (selection bias) Low risk Computer-generated random sequence”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

In Hillier 1990, other bias was at low risk because the study appeared to be free of other sources of bias.

“Other bias Low risk The study appears to be free of other sources of bias”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gibbs 1983, other bias was at high risk because of explicit pharmaceutical sponsorship.

“Pharmaceutical sponsorship -explicit”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

In Martens 1990, blinding of outcome assessment was at unclear risk of bias because it was not stated.

“Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not stated”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gibbs 1982, other bias was at high risk because of explicit pharmaceutical sponsorship.

“Pharmaceutical sponsorship -explicit”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Knodel 1988, other bias was at low risk.

“Other bias Low risk -”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Martens 1989, selective reporting was at unclear risk of bias because the protocol is not available, giving insufficient information to permit judgment.

“Selective reporting (reporting bias) Unclear risk The protocol is not available, insufficient information to permit judgment”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gall 1996, other bias was at high risk because of explicit pharmaceutical sponsorship.

“Pharmaceutical sponsorship -explicit”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gutierrez 1994, blinding of participants and personnel was at high risk of performance bias because the trial was single-blinded, with only the gynecologists giving the intervention blinded.

“The trial was single-blinded.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gibbs 1985, other bias was at high risk because of explicit pharmaceutical sponsorship.

“Pharmaceutical sponsorship -explicit”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Knodel 1988, allocation concealment was at low risk of bias because sealed numbered envelopes were utilized.

“Allocation concealment (selection bias) Low risk Sealed numbered envelopes utilized”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Martens 1990, incomplete outcome data was at low risk of bias because no drop-outs were described.

“Incomplete outcome data (attrition bias) All outcomes Low risk No drop-outs described”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Gutierrez 1994, allocation concealment was at unclear risk of bias because it was not stated.

“Allocation concealment (selection bias) Unclear risk Not stated”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Hillier 1990, incomplete outcome data was at low risk of bias because no missing outcome data were reported and data were balanced across groups, though drop-outs were not explicitly stated.

“Incomplete outcome data (attrition bias) All outcomes Low risk No missing outcome data reported and data is balanced in numbers across groups; drop outs not explicitly stated”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Hillier 1990, blinding of outcome assessment was at unclear risk of bias because it was not stated.

“Blinding of outcome assessment (detection bias) Unclear risk Note stated”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Figueroa-Damian 1996, other bias was at high risk because the Upjohn Company prepared the randomised code.

“The Upjohn Company prepared the randomised code”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In MacGregor 1992, other bias was at low risk because the study appeared to be free of other sources of bias.

“Other bias Low risk The study appears to be free of other sources of bias”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Gall 1996, incomplete outcome data was at low risk of attrition bias; 116 of 129 women (89.9%) were included in the analysis.

“116 women (89.9%) out of 129 women included in the analysis.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Hager 1989, selective reporting was at unclear risk of bias because the protocol is not available, though all expected outcomes appear to be reported.

“Selective reporting (reporting bias) Unclear risk Protocol is not available but all expected outcomes appear to be reported”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based). May combine two claims.

In Hager 1989, blinding of participants and personnel was at unclear risk of bias because the nurse and pharmacist maintained blinding, but it was unclear for patients and low risk for personnel.

“Blinding of participants and personnel (performance bias) All outcomes Unclear risk”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gutierrez 1994, selective reporting was at unclear risk of bias because the protocol is not available, giving insufficient information to permit judgement.

“Selective reporting (reporting bias) Unclear risk The protocol is not available, insufficient information to permit judgement”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gutierrez 1994, incomplete outcome data was at low risk of bias because 163 (80%) out of 204 women were evaluated, with 31 having no follow-up visits and 10 having infection at other organ sites.

“Incomplete outcome data (attrition bias) All outcomes Low risk 163 (80%) out of 204 women were evaluated.31 had no follow-up visits, 10 had infection at other organ sites”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gibbs 1982, allocation concealment was at low risk of selection bias because the solutions were prepared by the pharmacy as each patient was enrolled.

“The solutions were prepared by the pharmacy as each patient was enrolled.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Herman 1986, selective reporting was at unclear risk of bias because the protocol is not available, giving insufficient information to permit judgment.

“Selective reporting (reporting bias) Unclear risk The protocol is not available, insufficient information to permit judgment”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Livingston 2003, other bias was at low risk because the study appeared to be free of other sources of bias.

“Other bias Low risk The study appears to be free of other sources of bias”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Knodel 1988, incomplete outcome data was at low risk of bias because there were no drop outs.

“Incomplete outcome data (attrition bias) All outcomes Low risk No drop outs”

Probably not a substantial claim: may not pass S3 (load-bearing).

In MacGregor 1992, selective reporting was at unclear risk of bias because the protocol is not available, giving insufficient information to permit judgment.

“Selective reporting (reporting bias) Unclear risk The protocol is not available, insufficient information to permit judgment”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gibbs 1983, blinding of participants and personnel was at low risk of performance bias because solutions were prepared by the pharmacy and bottles were wrapped in dark plastic bags.

“Solutions were prepared by the pharmacy.”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Gutierrez 1994, blinding of outcome assessment was at low risk of bias because the physician evaluating the patient at follow-up was blinded to whether the patient had taken the oral antibiotic.

“Blinding of outcome assessment (detection bias) All outcomes Low risk”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Ledger 1974, incomplete outcome data was at low risk of bias because 110 (98%) were evaluated.

“Incomplete outcome data (attrition bias) All outcomes Low risk 110 (98%) were evaluated”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Herman 1986, other bias was at high risk because pharmaceutical sponsorship was explicit.

“Other bias High risk Pharmaceutical sponsorship -explicit”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Gutierrez 1994, other bias was at low risk because the study appeared to be free of other sources of bias.

“Other bias Low risk Study appeared to be free of other sources of bias”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing).

In Gutierrez 1994, random sequence generation was at unclear risk of bias because the report states 'random' without further description.

“Random sequence generation (selection bias) Unclear risk States”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Figueroa-Damian 1996, incomplete outcome data was at low risk of attrition bias; 20 of 21 enrolled patients (95.2%) completed treatment.

“20 (95.2%) patients completed treatment out of 21 patients enrolled.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Martens 1989, random sequence generation was at unclear risk of bias because the report states 'randomized' without further description.

“Random sequence generation (selection bias) Unclear risk States”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

In Hager 1989, blinding of outcome assessment was at unclear risk of bias because it was not stated.

“Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not stated”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

In Herman 1986, blinding of outcome assessment was at unclear risk of bias because it was not stated.

“Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not stated”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

In Gibbs 1982, blinding of outcome assessment was at low risk of detection bias because the study was described as double-blind.

“States”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gibbs 1983, blinding of outcome assessment was at low risk of detection bias because the study was described as a double-blind comparison.

“A double-blind comparison”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Gibbs 1983, incomplete outcome data was at low risk of attrition bias; 113 were enrolled and analyzed with no missing outcome data.

“113 enrolled and analyzed, no missing outcome data”

Probably not a substantial claim: may not pass S3 (load-bearing).

In MacGregor 1992, blinding of outcome assessment was at low risk of bias because all clinical decisions were made by the primary physicians, not by the study team.

“Blinding of outcome assessment (detection bias) All outcomes Low risk All clinical decisions made by the primary physicians, not by the study team”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gutierrez 1994, blinding of outcome assessment was at low risk of detection bias because the gynecologist outcome assessors were blinded.

“The trial was single-blinded.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In MacGregor 1992, random sequence generation was at low risk of bias because a computerized randomization schedule was used.

“Random sequence generation (selection bias) Low risk Computerized randomization schedule”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Livingston 2003, selective reporting was at unclear risk of bias because the protocol is not available, giving insufficient information to permit judgment.

“Selective reporting (reporting bias) Unclear risk The protocol is not available, insufficient information to permit judgment”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gutierrez 1994, incomplete outcome data was at low risk of attrition bias because drop-outs were less than 5% (1 woman from each group withdrew).

“Drop-outs < 5%. 1 woman from each group withdrew from the study.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Livingston 2003, blinding of participants and personnel was at high risk of bias because the study states 'open' and was not blinded.

“Blinding of participants and personnel (performance bias) All outcomes High risk States”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Greenberg 1987, other bias was at high risk because of explicit pharmaceutical sponsorship.

“Pharmaceutical sponsorship -explicit”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Hager 1989, allocation concealment was at unclear risk of bias because it was not stated.

“Allocation concealment (selection bias) Unclear risk Not stated”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Hillier 1990, selective reporting was at unclear risk of bias because the protocol is not available, giving insufficient information to permit judgment.

“Selective reporting (reporting bias) Unclear risk The protocol is not available, insufficient information to permit judgment”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Knodel 1988, random sequence generation was at low risk of bias because randomized blocks of 10 envelopes were used.

“Random sequence generation (selection bias) Low risk Randomized blocks of 10 envelopes”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Herman 1986, allocation concealment was at unclear risk of bias because it was not stated.

“Allocation concealment (selection bias) Unclear risk Not stated”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Gutierrez 1994, blinding of participants and personnel was at unclear risk of bias because the abstract states 'single-blinded study' but gives no further description.

“Blinding of participants and personnel (performance bias) All outcomes Unclear risk States”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

In Martens 1990, allocation concealment was at unclear risk of bias because it was not stated.

“Allocation concealment (selection bias) Unclear risk Not stated”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

In Martens 1989, blinding of outcome assessment was at unclear risk of bias because it was not stated.

“Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not stated”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Hillier 1990, blinding of participants and personnel was at high risk of bias because the study was an open randomised prospective trial and was not blinded.

“Blinding of participants and personnel (performance bias) All outcomes High risk States”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

In Ledger 1974, blinding of participants and personnel was at low risk of bias because the methods state 'Double-blinded study' but give no further description, and it was probably done.

“Blinding of participants and personnel (performance bias) All outcomes Low risk”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

In Greenberg 1987, incomplete outcome data was at low risk of attrition bias because there were no drop-outs.

“Drop-outs -none”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In MacGregor 1992, blinding of participants and personnel was at low risk of bias because the study was double blinded and all doses were identical in appearance and dispensed from the pharmacy.

“Blinding of participants and personnel (performance bias) All outcomes Low risk Double blinded.All doses were identical in appearance and were dispensed from the pharmacy”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Ledger 1974, selective reporting was at unclear risk of bias because the protocol is not available, giving insufficient information to permit judgment.

“Selective reporting (reporting bias) Unclear risk The protocol is not available, insufficient information to permit judgment”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Knodel 1988, blinding of outcome assessment was at high risk of bias because no blinding for outcomes was noted.

“Blinding of outcome assessment (detection bias) All outcomes High risk No blinding for outcomes noted”