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Table 5 Risk of bias, GRADE assessment, and evidence profile for included studies

From: Effectiveness of respectful care policies for women using routine intrapartum services: a systematic review

Population: Healthy women during childbirth
Setting: Maternity, Labour wards (Tanzania, S Africa, Kenya, Sudan)
Intervention: Policy to improve respectful care/reduce disrespect and abuse
Control: Usual practice
Data source: all data are from self-report unless specified otherwise; Publication bias could not be assessed due to few included studies
Outcome Quality assessment No of participants Relative effect
A single pooled estimate is not available and only a narrative synthesis of the evidence was provided in the review
Certainty
(GRADE)
Design [studyrefs] Risk of bias1 Inconsistency Indirectness Imprecision RMC policy Usual care
Birth experience
Respectful care One cRCT [23]
Two observational [25, 27]
Serious: cRCT 2 arms only; other data from observational studies Not serious Not serious Not serious 2983 (total n for RCT)
149 and 2469 (observational)
2983 (total n for RCT)
70 and 2000
(observational)
Effect estimate for the cRCT was aOR 3.44 (2.45–4.84).
Both observational studies had higher ratings of ‘respect’ in RMC arms (22.8% vs 0% in one study and 94.7% vs 89.7% in the other study)

MODERATE
Due to risk of bias
Satisfaction (very satisfied with delivery) One cRCT [23]
One observational [25]
Serious: cRCT had 2 arms only; other data were from observational study Not serious Not serious Serious: wide range of effect across the two studies 2983 (total n for RCT)
149 (observational)
2983 (total n for RCT)
70 (observational)
The effect estimate for the cRCT was aOR 0.98 (0.91–1.06). The observational study showed higher satisfaction with RMC (75.8%) than control (12.9%)
LOW
Due to risk of bias and inconsistency
Good quality of care (rated good or excellent) One cRCT [23]
One observational [25]
Serious: cRCT had 2 arms only; other data were from an observational study Not serious Not serious Not serious 2983 (total n for RCT)
149 (observational)
2983 (total n for RCT)
70 (observational)
The effect estimate for the cRCT was aOR 6.19 (4.29–8.94). The observational study also showed higher rating of quality of care with 63.1% vs 2.9% in RMC and control reporting this outcome
MODERATE
Due to risk of bias
Experience of mistreatment
Any disrespectful or abusive care One cRCT [23]
Two observational [25, 26]
Serious: cRCT had 2 arms only; other data were from observational studies Not serious Not serious Not serious 2983 (total n for RCT)
149 and 728 (observational)
2983 (total n for RCT)
64 and 641 (observational)
Effect estimate for the cRCT aOR 0.34 (95% CI 0.21–0.58) (3.2% vs 15.8%; RMC/ control). Observational studies had similar reductions -one from 70% to 18%; the other with aOR of 0.6 (95% CI 0.4–0.8) and rates of 13.2% vs 20.1% for RMC/control.
MODERATE
Due to risk of bias
Non-consent Two observational [24, 26] Serious: data were from observational studies Serious:
Direction of effect differed across the included studies
Not serious Serious:
Size of effect very different between studies
523 and 459 677 and 208 One study reported an increase [aOR 3.43 (95% CI 2.52–4.66)] with the intervention (80% vs 60.6%) and the other reported a reduction from 85.1% to 0% (all observed events)
VERY LOW
Due to risk of bias, inconsistency, and imprecision
Lack of privacy/
confidentiality
One cRCT [23]
Two observational [24, 26]
Serious: cRCT had 2 arms only; other data were from observational studies Serious:
Direction of effect differed across the istudies and different measures within studies
Not serious Serious:
Effect size very different between studies and different measures
Various no.s for the different studies and measures Various no.s for the different studies and measures The effect estimate for the cRCT was aOR 0.25, 95% CI 0.05–1.23).The observational studies reported various measures with estimates including a range of effects between and within studies.
VERY LOW
Due to risk of bias, inconsistency, and imprecision
Physical abuse Two cRCT [22, 23]
Two observational [24, 26]
Serious: both cRCTs had methodological limitations and other data were observational Not serious Not serious Not serious 2983 (total n for one cRCT) and 1039 for the other cRCT.
Various n in the observational studies for different measures (according to observed or self-reported events, and different types of physical abuse
2983 (total n for one cRCT) and 1051 for the other cRCT.
Various n in the observational studies for different measures (according to observed or self-reported events, and different types of physical abuse)
The effect estimate for one cRCT was aOR 0.22 (0.05–0.97). The other cRCT did not report a summary effect but had an average 50% reductionin the RMC arm (average 2% to 1%) and an increase in the control arm. Reductions in physical abuse consistently reported across the observational studies for various physical abuse measures.
MODERATE
Due to risk of bias
Verbal abuse One cRCT [22]
Two observational [24, 26]
Serious: risk
cRCTs had methodological limitations and other data were observational
Not serious Not serious Serious:
Estimates of effect include the possibility of harm
1039 for the cRCT
Various n in the observational studies for different measures (according to observed or self-reported)
1051 for the cRCT
677
Various no in the observational studies for different measures (according to observed or self-reported)
cRCT did not report a summary effect, and reported little difference at follow-up in both arms. One observational study reported no clear difference (on self-report and observed measures) and the other had an absolute 49% reduction
LOW
Due to risk of bias and imprecision
Neglect/abandonment Two cRCT [22, 23]
Two observational [24, 26]
Serious: both cRCTs had methodological limitations and other data were observational Not serious Not serious Serious:
Estimates of effect include the possibility of harm
2983 (total n for one cRCT) and 1039 for the other cRCT;
149 and 728 for observational studies
2983 (total n for one cRCT) and 1051 for the other cRCT;
64 and 641 for observational studies
Effects differed across studies. One cRCT reported reduction with RMC [aOR 0.36 (95% CI 0.19–0.71)]. The other cRCT did not report a summary effect but reported average 33% increase in the RMC arm (from 12% to 16%). One observational study had a 38% absolute decrease. The other had no clear difference.
LOW
Due to risk of bias and imprecision
Non- dignified care One cRCT [23]
One observational [24]
Serious: cRCT had 2 arms only; other data were from an observational study Not serious Not serious Serious:
Estimates of effect include the possibility of harm
2983 (total n for one cRCT)
149 (observational)
2983 (total n for one cRCT)
64 (observational)
The cRCT showed no difference but direction of effect favoured reduction [aOR 0.58 (95% CI 0.30–1.12)]. The observational study showed reductions from baseline in 8/9 submeasures of non-dignified care with RMC arm (observed events); reductions in 8/9 ranged from 13.5% (mother not told where to go in AN ward) to 81.3% (provider did not introduce themselves).
LOW
Due to risk of bias and imprecision
Detention Two observational [24, 26] Serious: data were from observational studies Serious:
The direction of effect across the two studies differed
Not serious Serious:
Estimates of effect include the possibility of harm
149 and 728 64 and 641 One study showed an absolute decrease of 1% and the other study showed an increase [aOR 1.28 (95% CI 0.93–1.76)]
VERY LOW
Due to risk of bias, inconsistencyand imprecision
Clinical outcomes
Perineal/
vaginal trauma
One cRCT [22] Serious: data from observational study Not serious Not serious Serious:
only one study
1039 1051 This study showed a reduction in episiotomy at follow up (mean rate of 21% at RMC sites vs 39% at control sites; P = 0.02)
LOW
Due to risk of bias and inconsistency
  1. High: This research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different is low
  2. Moderate: This research provides a good indication of the likely effect. The likelihood that the effect will be substantially different is moderate
  3. Low: This research provides some indication of the likely effect. However, the likelihood that it will be substantially different is high
  4. Very low: This research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different is very high
  5. Notes on grading of Risk of Bias
  6. All of the observational studies were assessed as having ‘serious risk’ of bias, due to lack of allocation concealment and blinding, lack of randomization, and use of self-report measures for some or all outcomes. Both cluster-RCTs were also assessed as having ‘serious risk’ of bias, due to lack of allocation concealment and blinding, and use of self-report measures for some outcomes. The RCTs were only downgraded one level for these issues as the nature of the intervention usually involved staff and/or service users in active participation, so they could not be blinded to allocation, and self-report is the only way of assessing if women experienced their care as respectful or not. Blinding of data collectors/analysts was not discussed in any of the included studies
  7. 1Assessment of risk of bias: All of the observational studies were assessed as having ‘serious risk’ of bias, due to lack of allocation concealment and blinding, lack of randomization, and use of self-report measures for some or all outcomes. Both cluster-RCTs were also assessed as having ‘serious risk’ of bias, due to lack of allocation concealment and blinding, and use of self-report measures for some outcomes