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