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Cochrane Database of Systematic Reviews

Intervenciones comunitarias y en sistemas sanitarios para mejorar la cobertura de atención prenatal y los desenlaces en salud

Información

DOI:
https://doi.org/10.1002/14651858.CD010994.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 01 diciembre 2015see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Embarazo y parto

Copyright:
  1. Copyright © 2016 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.
  2. This is an open access article under the terms of the Creative Commons Attribution‐Non‐Commercial Licence, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Autores

  • Lawrence Mbuagbaw

    Correspondencia a: Centre for the Development of Best Practices in Health (CDBPH), Yaoundé Central Hospital, Yaoundé, Cameroon

    [email protected]

    South African Cochrane Centre, South African Medical Research Council, Tygerberg, South Africa

  • Nancy Medley

    Cochrane Pregnancy and Childbirth Group, Department of Women's and Children's Health, The University of Liverpool, Liverpool, UK

  • Andrea J Darzi

    Clinical Epidemiological Unit, Clinical Research Institute (American University of Beirut Medical Center), Hamra, Lebanon

  • Marty Richardson

    Cochrane Infectious Diseases Group, Liverpool School of Tropical Medicine, Liverpool, UK

  • Kesso Habiba Garga

    Centre for the Development of Best Practices in Health (CDBPH), Yaoundé Central Hospital, Yaoundé, Cameroon

  • Pierre Ongolo‐Zogo

    Centre for the Development of Best Practices in Health (CDBPH), Yaoundé Central Hospital, Yaoundé, Cameroon

Contributions of authors

LM is the guarantor for this review. He contributed to the background and methods section of the protocol. LM, HG and POZ jointly conceived the idea for the review as a response to policy debates in Cameroon. All authors worked on the protocol and approved the final manuscript.

LM and NM assessed trials for inclusion. LM, AD and NM extracted data. AD contributed to the text describing included studies. MR is the review statistician; she adjusted data from cluster trials and prepared all of the meta‐analyses. LM and NM completed the text of the review.

Sources of support

Internal sources

  • Centre for Development of Best Practices in Health, Cameroon.

  • South African Cochrane Centre, Medical Research Council, South Africa.

External sources

  • Effective Health Care Research Consortium, UK.

  • UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization, Switzerland.

Declarations of interest

Lawrence Mbuagbaw ‐ none known.

Nancy Medley ‐ none known.

Andrea J Darzi ‐ none known.

Marty Richardson ‐ none known.

Theresa A Lawrie ‐ none known.

Kesso Habiba Garga ‐ none known.

Pierre Ongolo‐Zogo ‐ the Centre for the Development of Best Practices receives funding from UKaid through the Effective Health Care Research Consortium, UK to promote and support evidence based health care.

Acknowledgements

We acknowledge the assistance of the Centre for the Development of Best Practices in Health (CDBPH) and the South African Cochrane Centre (SACC). This review is written within the scope of activities of the Effective Health Care Research Consortium (EHCRC).

Nancy Medley's work was financially supported by the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization. The named authors alone are responsible for the views expressed in this publication.

We are grateful to Tess Lawrie for her help in preparing the tables of included studies and conducting 'Risk of bias' assessments; she also contributed text for the descriptions of included studies.

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

As part of the pre‐publication editorial process, this review has been commented on by three peers (an editor and two referees who are external to the editorial team), members of the Pregnancy and Childbirth Group's international panel of consumers and the Group's Statistical Adviser.

Version history

Published

Title

Stage

Authors

Version

2015 Dec 01

Health system and community level interventions for improving antenatal care coverage and health outcomes

Review

Lawrence Mbuagbaw, Nancy Medley, Andrea J Darzi, Marty Richardson, Kesso Habiba Garga, Pierre Ongolo‐Zogo

https://doi.org/10.1002/14651858.CD010994.pub2

2014 Feb 27

Health system and community level interventions for improving antenatal care coverage and health outcomes

Protocol

Lawrence Mbuagbaw, Kesso Habiba Garga, Pierre Ongolo‐Zogo

https://doi.org/10.1002/14651858.CD010994

Differences between protocol and review

The are some differences between our published protocol (Mbuagbaw 2014) and the full review.

  1. We have deleted the subgroup of single versus combined interventions because this analysis has been captured at the comparison level.

  2. Three new co‐authors have joined the review team: N Medley, A J Darzi, M Richardson and T Lawrie.

  3. We have used the GRADE approach as outlined in the GRADE Handbook to assess the quality of the body of evidence and we have included 'Summary of findings' tables.

  4. Methods/Assessment of Risk of bias: ‐ due to the inclusion of cluster‐randomised trials in the review, we have added several recommended 'Risk of bias' domains, including recruitment bias and analysis bias

  5. Methods/Measures of treatment effect/Dichotomous data ‐ we have presented these results as summary odds ratios not summary risk ratios as stated in our protocol.

  6. Methods/Assessment of heterogeneity ‐ we have added the following text: "We have left the overall totals turned off only if the effect estimates of different trials were so disparate that it made little clinical sense to combine the trials (for example, if effect estimates fell on opposite sides of the line of no difference and the trials' confidence intervals do not overlap). Overall, even with high heterogeneity in several outcomes, the effect estimates were reasonably similar, and confidence intervals always overlapped. We have not turned off the totals for any outcome below".

  7. Methods/Unit of analysis issues ‐ we have expanded this section. We have provided more details about how we handled cluster‐randomised trials. We have expanded the methods for 'other unit of analysis issues' relating to studies with multiple treatment arms. We have also discussed issues relating to studies involving multiple pregnancies.

  8. Methods/subgroup analysis and investigation of heterogeneity ‐ we have removed 'single versus combined interventions' from our list of planned subgroup analyses since this is a comparison rather than a subgroup analysis.

  9. We did not measure agreement during the screening and data extraction processes.

  10. Methods/types of studies ‐ in our protocol we did not specify whether studies published in abstract form were eligible for inclusion. In the full review we have clarified that "Trials reported in abstract form were eligible for inclusion in the review; however, we did not include any trial based on an abstract report alone."

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.1 ANC coverage: four or more visits.
Figuras y tablas -
Figure 4

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.1 ANC coverage: four or more visits.

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.2 Pregnancy‐related deaths.
Figuras y tablas -
Figure 5

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.2 Pregnancy‐related deaths.

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.6 Deliveries in a health facility.
Figuras y tablas -
Figure 6

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.6 Deliveries in a health facility.

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.13 Perinatal mortality.
Figuras y tablas -
Figure 7

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.13 Perinatal mortality.

Comparison 1 One intervention versus no intervention, Outcome 1 ANC coverage: four or more visits.
Figuras y tablas -
Analysis 1.1

Comparison 1 One intervention versus no intervention, Outcome 1 ANC coverage: four or more visits.

Comparison 1 One intervention versus no intervention, Outcome 2 Pregnancy‐related deaths.
Figuras y tablas -
Analysis 1.2

Comparison 1 One intervention versus no intervention, Outcome 2 Pregnancy‐related deaths.

Comparison 1 One intervention versus no intervention, Outcome 3 ANC coverage: one or more visits.
Figuras y tablas -
Analysis 1.3

Comparison 1 One intervention versus no intervention, Outcome 3 ANC coverage: one or more visits.

Comparison 1 One intervention versus no intervention, Outcome 4 Pregnant women initiating ANC in first trimester.
Figuras y tablas -
Analysis 1.4

Comparison 1 One intervention versus no intervention, Outcome 4 Pregnant women initiating ANC in first trimester.

Comparison 1 One intervention versus no intervention, Outcome 5 Pregnant women receiving ANC from health professional.
Figuras y tablas -
Analysis 1.5

Comparison 1 One intervention versus no intervention, Outcome 5 Pregnant women receiving ANC from health professional.

Comparison 1 One intervention versus no intervention, Outcome 6 Deliveries in a health facility.
Figuras y tablas -
Analysis 1.6

Comparison 1 One intervention versus no intervention, Outcome 6 Deliveries in a health facility.

Comparison 1 One intervention versus no intervention, Outcome 8 Proportion of women with tetanus protection at birth.
Figuras y tablas -
Analysis 1.8

Comparison 1 One intervention versus no intervention, Outcome 8 Proportion of women with tetanus protection at birth.

Comparison 1 One intervention versus no intervention, Outcome 9 Proportion of women treated for syphilis.
Figuras y tablas -
Analysis 1.9

Comparison 1 One intervention versus no intervention, Outcome 9 Proportion of women treated for syphilis.

Comparison 1 One intervention versus no intervention, Outcome 10 Proportion of women with HIV who receive a complete antiretroviral course for prevention of mother‐to‐child transmission of HIV.
Figuras y tablas -
Analysis 1.10

Comparison 1 One intervention versus no intervention, Outcome 10 Proportion of women with HIV who receive a complete antiretroviral course for prevention of mother‐to‐child transmission of HIV.

Comparison 1 One intervention versus no intervention, Outcome 11 Preterm labour.
Figuras y tablas -
Analysis 1.11

Comparison 1 One intervention versus no intervention, Outcome 11 Preterm labour.

Comparison 1 One intervention versus no intervention, Outcome 12 Low birthweight.
Figuras y tablas -
Analysis 1.12

Comparison 1 One intervention versus no intervention, Outcome 12 Low birthweight.

Comparison 1 One intervention versus no intervention, Outcome 13 Perinatal mortality.
Figuras y tablas -
Analysis 1.13

Comparison 1 One intervention versus no intervention, Outcome 13 Perinatal mortality.

Comparison 2 Combination of interventions versus no intervention, Outcome 1 ANC coverage: four or more visits.
Figuras y tablas -
Analysis 2.1

Comparison 2 Combination of interventions versus no intervention, Outcome 1 ANC coverage: four or more visits.

Comparison 2 Combination of interventions versus no intervention, Outcome 2 Pregnancy‐related deaths.
Figuras y tablas -
Analysis 2.2

Comparison 2 Combination of interventions versus no intervention, Outcome 2 Pregnancy‐related deaths.

Comparison 2 Combination of interventions versus no intervention, Outcome 3 ANC coverage: one or more visits.
Figuras y tablas -
Analysis 2.3

Comparison 2 Combination of interventions versus no intervention, Outcome 3 ANC coverage: one or more visits.

Comparison 2 Combination of interventions versus no intervention, Outcome 4 Pregnant women initiating ANC in first trimester.
Figuras y tablas -
Analysis 2.4

Comparison 2 Combination of interventions versus no intervention, Outcome 4 Pregnant women initiating ANC in first trimester.

Comparison 2 Combination of interventions versus no intervention, Outcome 5 Pregnant women receiving ANC from health professional.
Figuras y tablas -
Analysis 2.5

Comparison 2 Combination of interventions versus no intervention, Outcome 5 Pregnant women receiving ANC from health professional.

Comparison 2 Combination of interventions versus no intervention, Outcome 6 Deliveries in a health facility.
Figuras y tablas -
Analysis 2.6

Comparison 2 Combination of interventions versus no intervention, Outcome 6 Deliveries in a health facility.

Comparison 2 Combination of interventions versus no intervention, Outcome 8 Proportion of women with tetanus protection at birth.
Figuras y tablas -
Analysis 2.8

Comparison 2 Combination of interventions versus no intervention, Outcome 8 Proportion of women with tetanus protection at birth.

Comparison 2 Combination of interventions versus no intervention, Outcome 9 Preterm labour.
Figuras y tablas -
Analysis 2.9

Comparison 2 Combination of interventions versus no intervention, Outcome 9 Preterm labour.

Comparison 2 Combination of interventions versus no intervention, Outcome 10 Low birthweight.
Figuras y tablas -
Analysis 2.10

Comparison 2 Combination of interventions versus no intervention, Outcome 10 Low birthweight.

Comparison 2 Combination of interventions versus no intervention, Outcome 11 Perinatal mortality.
Figuras y tablas -
Analysis 2.11

Comparison 2 Combination of interventions versus no intervention, Outcome 11 Perinatal mortality.

Comparison 4 Combination of interventions versus one intervention, Outcome 1 ANC coverage: four or more visits.
Figuras y tablas -
Analysis 4.1

Comparison 4 Combination of interventions versus one intervention, Outcome 1 ANC coverage: four or more visits.

Comparison 4 Combination of interventions versus one intervention, Outcome 2 Pregnancy‐related deaths.
Figuras y tablas -
Analysis 4.2

Comparison 4 Combination of interventions versus one intervention, Outcome 2 Pregnancy‐related deaths.

Comparison 4 Combination of interventions versus one intervention, Outcome 3 ANC coverage: one or more visits.
Figuras y tablas -
Analysis 4.3

Comparison 4 Combination of interventions versus one intervention, Outcome 3 ANC coverage: one or more visits.

Comparison 4 Combination of interventions versus one intervention, Outcome 4 Deliveries in a health facility.
Figuras y tablas -
Analysis 4.4

Comparison 4 Combination of interventions versus one intervention, Outcome 4 Deliveries in a health facility.

Comparison 4 Combination of interventions versus one intervention, Outcome 5 Perinatal mortality.
Figuras y tablas -
Analysis 4.5

Comparison 4 Combination of interventions versus one intervention, Outcome 5 Perinatal mortality.

Comparison 4 Combination of interventions versus one intervention, Outcome 6 Proportion of women with tetanus protection at birth.
Figuras y tablas -
Analysis 4.6

Comparison 4 Combination of interventions versus one intervention, Outcome 6 Proportion of women with tetanus protection at birth.

Comparison 5 Different combinations of interventions, Outcome 1 ANC coverage: four or more visits.
Figuras y tablas -
Analysis 5.1

Comparison 5 Different combinations of interventions, Outcome 1 ANC coverage: four or more visits.

Comparison 5 Different combinations of interventions, Outcome 4 Deliveries in a health facility.
Figuras y tablas -
Analysis 5.4

Comparison 5 Different combinations of interventions, Outcome 4 Deliveries in a health facility.

Comparison 6 Subgroup analysis, Outcome 1 Health systems vs Population ANC coverage: four or more visits.
Figuras y tablas -
Analysis 6.1

Comparison 6 Subgroup analysis, Outcome 1 Health systems vs Population ANC coverage: four or more visits.

Comparison 6 Subgroup analysis, Outcome 2 Health systems vs Population Pregnancy‐related deaths.
Figuras y tablas -
Analysis 6.2

Comparison 6 Subgroup analysis, Outcome 2 Health systems vs Population Pregnancy‐related deaths.

Comparison 6 Subgroup analysis, Outcome 3 Country Income Low vs High ANC at least 4 visits.
Figuras y tablas -
Analysis 6.3

Comparison 6 Subgroup analysis, Outcome 3 Country Income Low vs High ANC at least 4 visits.

Comparison 7 One intervention versus no intervention ‐ Sensitivity analysis by risk of bias, Outcome 1 ANC coverage: four or more visits.
Figuras y tablas -
Analysis 7.1

Comparison 7 One intervention versus no intervention ‐ Sensitivity analysis by risk of bias, Outcome 1 ANC coverage: four or more visits.

Comparison 8 Combination of interventions versus no intervention ‐ Sensitivity analysis by risk of bias, Outcome 1 ANC coverage: four or more visits.
Figuras y tablas -
Analysis 8.1

Comparison 8 Combination of interventions versus no intervention ‐ Sensitivity analysis by risk of bias, Outcome 1 ANC coverage: four or more visits.

Summary of findings for the main comparison. One intervention versus no intervention

Comparison 1: One intervention versus no intervention

Patient or population: improving antenatal care coverage and health outcomes among pregnant women
Setting: Argentina, Bangladesh, Brazil, Cuba, Ghana, Honduras, India, Malawi, Mexico, Mongolia, Nepal, Rwanda, South Africa, Tanzania, UK, Vietnam, Zanzibar, Zimbabwe
Intervention: One intervention
Comparison: No intervention

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with no intervention

Risk with One intervention

ANC coverage: four or more visits

Moderate

Average OR 1.11
(1.01 to 1.22)

45022
(10 RCTs)

⊕⊕⊕⊕
HIGH1

This is the primary analysis, ICC 0.02.

529 per 1000

555 per 1000
(531 to 578)

Pregnancy‐related deaths

Moderate

Average OR 0.69
(0.45 to 1.08)

114930
(10 RCTs)

⊕⊕⊝⊝
LOW 2 3

700 per 1000000

483 per 1000000
(315 to 756)

ANC coverage: one or more visits

Moderate

Average OR 1.68
(1.02 to 2.79)

19281
(6 RCTs)

⊕⊕⊕⊝
MODERATE 4

490 per 1000

617 per 1000
(495 to 728)

Deliveries in a health facility

Moderate

Average OR 1.08
(1.02 to 1.15)

74299
(10 RCTs)

⊕⊕⊕⊕
HIGH

645 per 1000

662 per 1000
(650 to 676)

Perinatal mortality

Moderate

Average OR 0.96
(0.89 to 1.03)

189164
(15 RCTs)

⊕⊕⊕⊝
MODERATE 2 5

40 per 1000

38 per 1000
(36 to 41)

Low birthweight

Moderate

Average OR 0.94
(0.82 to 1.06)

27154
(5 RCTs)

⊕⊕⊕⊕
HIGH

125 per 1000

118 per 1000
(105 to 132)

Intermittent Prophylactic Treatment for malaria

Study population

not pooled

00
(0 study)

No trial included in this review reported this outcome.

not pooled

not pooled

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio.

Denominators for the calculation of the absolute comparative effects have been taken from individual trial reports or from Prost 2013. Where different denominators are stated in different reports, we have taken the larger. The median control group risk has been calculated from event and participant raw data, where this was available. If we found no raw event and participant data in published reports, these trials were not included in the calculation of the median control group risk.

Both the participant totals and the median control group risk are for illustrative purposes only. In the majority of the trials in this review, the final odds ratio presented will not correspond with raw event and participant data due to adjustments made for the effects of cluster design.

We have designated the control risk as moderate because it is based on the median of a wide range of baseline rates in control groups.

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Statistical heterogeneity, I2 = 52%; we did not downgrade for heterogeneity unless the I2 > 60%.

2 Downgraded one level due to serious risk of bias. Most weight from trials with design limitations (‐1).

3 Downgraded one level due to serious imprecision. Wide confidence interval crossing the line of no effect (‐1).

4 Downgraded one level due to serious inconsistency. Statistical heterogeneity, I2= 76% (‐1).

5 Statistical heterogeneity, I2= 58%; we did not downgrade for heterogeneity unless the I2 > 60%.

Figuras y tablas -
Summary of findings for the main comparison. One intervention versus no intervention
Summary of findings 2. Combination of interventions versus no intervention

Comparison 2: Combination of interventions versus no intervention

Patient or population: improving antenatal care coverage and health outcomes among pregnant women
Setting: Eastern China, Honduras, India, Laos, Malawi, Pakistan, South Africa, USA
Intervention: Combination of interventions
Comparison: No intervention

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with no intervention

Risk with Combination of interventions

ANC coverage: four or more visits

Moderate

Average OR 1.48
(0.99 to 2.21)

7840
(6 RCTs)

⊕⊕⊝⊝
LOW 1 2 3

This is the primary analysis, ICC 0.02.

430 per 1000

528 per 1000
(428 to 625)

Pregnancy‐related deaths

Moderate

Average OR 0.70
(0.39 to 1.26)

13756
(3 RCTs)

⊕⊕⊕⊝
MODERATE 3

600 per 100000

421 per 100000
(235 to 755)

ANC coverage: one or more visits

Moderate

Average OR 1.79
(1.47 to 2.17)

12426
(5 RCTs)

⊕⊕⊕⊝
MODERATE 3

580 per 1000

712 per 1000
(670 to 750)

Deliveries in a health facility

Moderate

Average 1.53
(0.96 to 2.43)

12314
(5 RCTs)

⊕⊕⊕⊝
MODERATE 3

165 per 1000

252 per 1000
(158 to 401)

Perinatal mortality

Moderate

Average 0.74
(0.57 to 0.95)

39130
(5 RCTs)

⊕⊕⊕⊝
MODERATE 4

90 per 1000

67 per 1000
(51 to 58)

Low birthweight

Moderate

Average 0.61
(0.46 to 0.80)

2084
(2 RCTs)

⊕⊕⊕⊝
MODERATE 1

165 per 1000

101 per 1000
(76 to 132)

Intermittent Prophylactic Treatment for malaria

Study population

not pooled

00
(0 study)

No trial eligible for this comparison reported this outcome

not pooled

not pooled

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).CI: Confidence interval; RR: Risk ratio; OR: Odds ratio. Denominators for the calculation of the absolute comparative effects have been taken from individual trial reports or from Prost 2013. Where different denominators are stated in different reports, we have taken the larger. The median control group risk has been calculated from event and participant raw data, where this was available. If we found no raw event and participant data in published reports, these trials were not included in the calculation of the median control group risk.

Both the participant totals and the median control group risk are for illustrative purposes only. In the majority of the trials in this review, the final odds ratio presented will not correspond with raw event and participant data due to adjustments made for the effects of cluster design.

We have designated the control risk as moderate because it is based on the median of a wide range of baseline rates in control groups.

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Most weight from trials with design limitations (‐1).

2 Statistical heterogeneity, I2 = 48% ; we did not downgrade for heterogeneity unless the I2 > 60%.

3 Wide confidence interval crossing the line of no effect (‐1).

4 Statistical heterogeneity, I2 = 83% (‐1).

Figuras y tablas -
Summary of findings 2. Combination of interventions versus no intervention
Table 1. Primary outcome 1.1 Proportion of women with at least 4 ANC visits

Study

Measure of effect

Statistical approach1

Intervention

Control

Barber 2008

Beta coefficient: 0.0235 (Cash transfer, instrumental variable model; p. 1411, Barber 2008)

Calculate exp(beta) to get OR and CI

712

180

Basinga 2011

Beta (95% CI): 0.008 (‐0.063 to 0.079)

Calculate exp(beta) to get OR and CI

Reported only the total n, stated as = 2223

Fottrell 2013

Adjusted Odds Ratio (95%CI) 1.37 (0.99 to 1.88)

Cluster adjusted, straight into RevMan

9106

8834

Kenyon 2012

RR = 1.01 (95% CI 0.91 to 1.13)

Non‐cluster trial, calculated OR

322/599

320/604

Kirkwood 2013

RR 1·02 (0·96 to 1·09)

Adjusted using ICC 0.02

5975/7859

5988/8121

Lund 2012

Adjusted OR 2.39 (1.03 to 5.55) adjusted for cluster effect and significant variables

Cluster adjusted, straight into RevMan

574/1311

385/1239

Mori 2015

Adjusted OR 1.25 (0.31 to 5.00) trial statistician (H Noma) calculated unpublished OR for this systematic review. OR adjusted for cluster effect and significant variables.

Cluster adjusted, straight into RevMan

243/252

237/248

Morris 2004
(Household package arm and service package arm added together)

Calculated from change scores, Table 2 Program effects p. 2034 of main report.

Adjusted using ICC 0.02

166/293 + 112/232

151/313

Walker 2013

Adjusted OR 95% CI 1.8(1.2 to 2.8). OR adjusted various characteristics and cluster ('in accordance with WHO standards' from Table 3, p. 1203 Walker 2013)

Cluster adjusted, straight into RevMan

78/1129

39/924

1Main analysis with ICC of 0.02. We decided to use the same ICC for this outcome as for Proportion of women with one ANC visit. ICC of 0.02 provided in Manandhar 2004 and Wu 2011. We performed sensitivity analyses with the ICC of 0.08, a midrange of the ICC values in Pagel 2011.

Figuras y tablas -
Table 1. Primary outcome 1.1 Proportion of women with at least 4 ANC visits
Table 2. Primary outcome 1.2 Pregnancy related deaths

Study

Measure of effect

Statistical approach1

Intervention

Control

Lewycka 20132 women's groups only

Adjusted

14/4773

15/2530

Lewycka 2013a peer counselling only

Adjusted

18/4690

14/2529

Lund 2014

Adjusted

4/1351

1/1286

Majoko 2007

OR 1.94 (0.31‐15.2)

Adjusted raw data because the reported OR is asymmetrical. No reply from trial authors regarding our query.

4/6696

2/6483

Manandhar 2004

Adjusted

2/2899

11/3226

More 2012

Adjusted

20/7656

24/7536

Mori 2015

Continuity correction for no events in either treatment arm. Unpublished data provided by trial author

0/252

0/248

Persson 2013

Adjusted

1/11,906

4/10655

Fottrell 2013

Adjusted

14/8819

23/8602

Villar 2001

Adjusted

7/11672

6/11121

1All data adjusted using an ICC of 0.00247 as suggested by Professor J P Souza by email.

2Mortality data from Trial Profile (Lewycka 2013, p. 1724). Control group (n = 5059) split for this analysis.

Figuras y tablas -
Table 2. Primary outcome 1.2 Pregnancy related deaths
Table 3. SOF outcome 1.3 ANC coverage: one or more visits

Study

Measure of effect

Statistical approach1

Intervention

Control

Basinga 2011

beta (95% CI): 0.002 (‐0.021 to 0.025);

Calculated ln (OR) and se (ln OR)

Reported only the total n = 2309

Baqui 2008

Adjusted

2297/3421

828/1689

Darmstadt 2010

Adjusted

1192/1732

864/1759

Manandhar 2004

Adjusted OR 2.82 (1.41 to 5.62)

Straight into RevMan. Worked out what ICC they used to adjust for clustering

1747/3190

1051/3524

Mori 2015

Adjusted OR 1.02 (0.01 to 131.42) trial statistician provided unpublished OR adjusted for clustering and significant variables

Straight into RevMan

252/252

248/248

Persson 2013

Adjusted OR 2.27 95% CI 1.07 to 4.80. For years 1‐3.

Straight into RevMan

596/656

482/587

1ICC of 0.02 provided in Manandhar 2004 and Wu 2011.

Figuras y tablas -
Table 3. SOF outcome 1.3 ANC coverage: one or more visits
Table 4. SOF outcome 1.6 Deliveries in health facilities

Study

Measure of effect

Statistical approach1

Intervention

Control

Barber 2008

Adjusted

480/776

130/203

Basinga 2011

beta (95% CI): 0.081 (0.015 to 0.146)

Calculated ln (OR) and se (ln OR)

Reported only total n = 2108

Darmstadt 2010

Adjusted

350/1732

290/1759

Fottrell 2013

Adjusted Odds Ratio (95%CI) 1.05 (0.88 to 1.25)

Straight into RevMan

Kirkwood 2013

Adjusted

5373/7859

5539/8121

Mojoko 2007

Adjusted OR for delivery at health centre 1.7 (0.88 to 3.0) ICC used 0.103

Decided to use delivery at health centre outcome rather than hospital outcome. The OR is asymmetrical so will not go in RevMan ‐ have adjusted the data using the reported ICC 0.103

Health centre 2660/5261

1986/5137

Manandhar 2004

Adjusted

201/2945

66/3270

More 2012

Adjusted OR 0.92 (0.58 to 1.47)

Straight into RevMan

6602 / 7656

6573/ 7536

Penfold 2014

Adjusted

187/256

166/254

Persson 2013

Adjusted OR 1.88 95% CI 0.60 to 5.87. For years 1‐3.

Straight into RevMan

594/656

510/587

1Data adjusted using ICC 0.103 from Majoko 2007.

Figuras y tablas -
Table 4. SOF outcome 1.6 Deliveries in health facilities
Table 5. SOF outcome 1.12 Low birth weight

Trial

Measure of effect

Statistical approach1

Intervention

Control

Kenyon 2012

RR 0.92 (0.74, 1.14) P = 0.43

Not cluster trial ‐ calculated OR

127/605

141/613

Mori 2015

Adjusted OR 0.65 (0.26 to 1.59) trial statistician (H Noma) calculated unpublished OR adjusted for cluster effects and significant variables

Straight into RevMan

8/251

12/247

Richter 2014

Adjusted

67/377

52/414

Villar 1992

OR 0.88 (95% CI 0.67 to 1.16)

Straight into RevMan

115/1033

130/1040

Villar 2001

Adjusted

910/11534

852/11040

1ICC from Piaggio 2001 paper of 0.0004 for ANC trial with average cluster size 426.

Figuras y tablas -
Table 5. SOF outcome 1.12 Low birth weight
Table 6. SOF outcome 1.13 Perinatal mortality

Trial

Effect Measure

Statistical approach1

Intervention

Control

Baqui 2008

Adjusted

2552/32279

1260/15914

Darmstadt 2010

Adjusted

224/4800

255/5472

Fottrell 2013

Risk Ratio (95% CI) adjusted without Tea‐garden residents 0.87 (0.62 to 1.22)

Calculated OR

474/9106

503/8834

Kenyon 2012

RR 2.04 (0.51 to 8.12) P = 0.30

Not a cluster trial.

Calculated adjusted OR

6/604

3/616

Kirkwood 2013

Adjusted

288/8035

355/8294

Lewycka 2013a peer counselling only

Adjusted

150/4690

103/2529

Lewycka 2013 women's groups only

Adjusted

173/4773

104/2530

Lund 2012

Adjusted OR 0.50 (0.27 to 0.93) adjusted for clustering and covariates associated with perinatal mortality

Straight into RevMman

25/1300

44/1236

Majoko 2007

OR 1.11 (0.89 to 1.39)

185/6614

161/6384

Manandhar 2004

Adjusted as below

123/2972

147/3303

More 2012

Adjusted

205/8017

173/7844

Mori 2015

Unpublished OR 0.49 (0.05 to 4.54) provided by trial statistician (H Noma) adjusted for cluster effect and significant variables

Straight into RevMan

1/253

2/248

Persson 2013

Adjusted

283/11906

290/10655

Villar 1992

OR 0.89 (95% CI 0.55 to 1.47)

Straight into RevMan

3.6% of 1033

4% of 1040

Villar 2001 (WHO 2001)

From Vogel 2013 Adjusted RR 1.18 (1.01 to 1.37). Adjusted for clustering and for risk strata, smoking, education less than primary, hospital admission in last pregnancy, previous surgery on reproductive tract, late booking, vaginal bleeding in the first trimester, age, previous low birth weight, parity.

Calculated adjusted OR

234/11672

190/11121

1Piaggio 2001 reports ICC for perinatal mortality of 0.

Figuras y tablas -
Table 6. SOF outcome 1.13 Perinatal mortality
Table 7. Primary outcome 2.1: Proportion of women with at least 4 ANC visits

Study

Measure of effect

Statistical approach1

Intervention

Control

Bhutta 2011

Adjusted

302/2339

191/2135

Laken 1995

Not cluster trial – two intervention arms added together. calculated ln (OR) and se (Ln OR)

104/194

101/101

Le Roux 2013

1.00 (0.74, 1.34) OR Random effects logistic regression, adjusted for neighbourhood clustering. Models for outcomes among HIV‐positive mothers control for baseline employment.

Straight into RevMan

474/608

439/549

Morris 2004
both packages

Calculated from change scores, Table 2 Program effects p. 2034 of main report. Intervention 38.1% + 18.4% = 56.5% of the final sample size in this group which is 110; 48.9% ‐ 0.7% = 48.2 % in the control group (n = 313).
Adjusted as below

62/110

151/313

Manthip 2015

Adjusted

62/127

53/190

Wu 2011

Calculated adjusted SE from P value 0.246

376/673

253/591

1Primary analysis using ICC of 0.02.

Figuras y tablas -
Table 7. Primary outcome 2.1: Proportion of women with at least 4 ANC visits
Table 8. Primary outcome 2.2: Pregnancy related deaths

Study

Measure of effect

Statistical approach

Intervention

Control

Kumar 2008

Adjusted

12/2749

10/1142

Laken 1995

0.9713 (0.0191 to 49.4211)

Straight into RevMan

0/104

0/101

Lewycka 2013

Adjusted

23/4601

29/5059

1All data adjusted using an ICC of 0.00247 as suggested by Professor J P Souza by email.

Figuras y tablas -
Table 8. Primary outcome 2.2: Pregnancy related deaths
Table 9. SOF outcome 2.3 ANC coverage: one or more ANC visits

Study

Measure of effect

Statistical approach1

Intervention

Control

Bhutta 2011

Adjusted

1616/2339

1230/2135

Kumar 2008

24.5% of 2681 intervention and 14.4% of 1129 controls: RR (95%CI); 1.67 (1.47 to 1.91)

Calculated adjusted OR

657/2681

163/1129

Wahlstrom 2011

Adjusted

99/127

122/190

Midhet 2010

Adjusted

Womens group 254/836
couples group 187/703
women + couples = 441/1539

191/1022

Wu 2011

Calculated the ICC that they used to adjust the results using the reported P = 0.758

85/88

74/77

1As for first comparison, ICC of 0.02 used for this outcome. Both Manandhar 2004 and Wu 2011 use ICCS of approximately 0.02

Figuras y tablas -
Table 9. SOF outcome 2.3 ANC coverage: one or more ANC visits
Table 10. SOF outcome 2.6 Deliveries in health facilities

Study

Measure of effect

Statistical approach1

Intervention

Control

Bhutta 2011

Adjusted as below

1272/2339

936/2135

Kumar 2008

RR (95%CI); 1.35 (0.88 to 2.07)

Calculated adjusted OR

507/2681

158/1129

Laken 1995

NOT A CLUSTER TRIAL ‐ calculated OR and confidence interval

104/104

101/101

Midhet 2010

Adjusted as below

46/ 836 in women's group
42/703 in couple's group
Combined intervention arms: 88/1539

39/1022

Wu 2011

Calculated what the ICC would have been using the reported adjusted p‐value (P = 0.231)

625/673

517/591

1ICC from Wu (0.099).

Figuras y tablas -
Table 10. SOF outcome 2.6 Deliveries in health facilities
Table 11. SOF outcome 2.10 Low birthweight

Trial

Statistical approach1

Intervention

Control

Klerman 2001

Straight into RevMan ‐ not cluster trial

39/311

33/296

Le roux 2013

Calculated adjusted OR

88/608

123/549

ICC from Piaggio paper of 0.0004 for ANC trial with average cluster size 426

Figuras y tablas -
Table 11. SOF outcome 2.10 Low birthweight
Table 12. SOF outcome 2.11 Perinatal deaths

Trial

Statistical approach1

Intervention

Control

Bhutta 2011

Calculated OR

880/12028

972/11005

Laken 1995

Calculated OR

0/96

0/91

Lewycka 2013

Calculated OR

198/4601

207/5059

Midhet 2010

Calculated OR

Women's group 36/836 plus couple's group 42/703

Control 86/1022

Kumar 2008

Calculated OR

219/ 2609

155/ 1079

1Piaggio 2001 reports and ICC of 0 for perinatal deaths.

Figuras y tablas -
Table 12. SOF outcome 2.11 Perinatal deaths
Comparison 1. One intervention versus no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 ANC coverage: four or more visits Show forest plot

10

Odds Ratio (Random, 95% CI)

Subtotals only

1.1 Primary analysis (ICC 0.02 for studies Kirkwood and Morris)

10

45022

Odds Ratio (Random, 95% CI)

1.11 [1.01, 1.22]

1.2 Sensitivity analysis using ICC 0.08

10

45022

Odds Ratio (Random, 95% CI)

1.11 [1.00, 1.22]

2 Pregnancy‐related deaths Show forest plot

10

114930

Odds Ratio (Random, 95% CI)

0.69 [0.45, 1.08]

3 ANC coverage: one or more visits Show forest plot

6

Odds Ratio (Random, 95% CI)

1.68 [1.02, 2.79]

4 Pregnant women initiating ANC in first trimester Show forest plot

1

Odds Ratio (Random, 95% CI)

1.20 [0.99, 1.45]

5 Pregnant women receiving ANC from health professional Show forest plot

1

Odds Ratio (Random, 95% CI)

1.13 [0.84, 1.52]

6 Deliveries in a health facility Show forest plot

10

Odds Ratio (Random, 95% CI)

1.08 [1.02, 1.15]

7 Intermittent Prophylactic Treatment for malaria

0

0

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Proportion of women with tetanus protection at birth Show forest plot

8

Odds Ratio (Random, 95% CI)

1.03 [0.92, 1.15]

9 Proportion of women treated for syphilis Show forest plot

2

Odds Ratio (Random, 95% CI)

1.46 [0.94, 2.26]

10 Proportion of women with HIV who receive a complete antiretroviral course for prevention of mother‐to‐child transmission of HIV Show forest plot

1

Odds Ratio (Random, 95% CI)

0.44 [0.26, 0.74]

11 Preterm labour Show forest plot

4

Odds Ratio (Random, 95% CI)

1.00 [0.93, 1.09]

12 Low birthweight Show forest plot

5

Odds Ratio (Random, 95% CI)

0.94 [0.82, 1.06]

13 Perinatal mortality Show forest plot

15

Odds Ratio (Random, 95% CI)

0.96 [0.89, 1.03]

Figuras y tablas -
Comparison 1. One intervention versus no intervention
Comparison 2. Combination of interventions versus no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 ANC coverage: four or more visits Show forest plot

6

Odds Ratio (Random, 95% CI)

Subtotals only

1.1 Primary analysis (ICC 0.02 for studies Bhutta and Morris)

6

7840

Odds Ratio (Random, 95% CI)

1.48 [0.99, 2.21]

1.2 ICC 0.08

6

7840

Odds Ratio (Random, 95% CI)

1.45 [0.95, 2.23]

2 Pregnancy‐related deaths Show forest plot

3

13756

Odds Ratio (Random, 95% CI)

0.70 [0.39, 1.26]

3 ANC coverage: one or more visits Show forest plot

5

Odds Ratio (Random, 95% CI)

1.79 [1.47, 2.17]

4 Pregnant women initiating ANC in first trimester Show forest plot

1

Odds Ratio (Random, 95% CI)

0.83 [0.47, 1.47]

5 Pregnant women receiving ANC from health professional Show forest plot

2

Odds Ratio (Random, 95% CI)

2.97 [1.67, 5.30]

6 Deliveries in a health facility Show forest plot

5

Odds Ratio (Random, 95% CI)

1.53 [0.96, 2.43]

7 Intermittent Prophylactic Treatment for malaria

0

0

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Proportion of women with tetanus protection at birth Show forest plot

3

Odds Ratio (Random, 95% CI)

1.48 [1.18, 1.87]

9 Preterm labour Show forest plot

1

607

Odds Ratio (M‐H, Random, 95% CI)

0.74 [0.45, 1.20]

10 Low birthweight Show forest plot

2

Odds Ratio (Random, 95% CI)

0.61 [0.46, 0.80]

11 Perinatal mortality Show forest plot

5

Odds Ratio (Random, 95% CI)

0.74 [0.57, 0.95]

Figuras y tablas -
Comparison 2. Combination of interventions versus no intervention
Comparison 3. Two interventions compared

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 ANC coverage: four or more visits

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Pregnancy‐related deaths

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 ANC coverage: one or more visits

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Deliveries in a health facility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Perinatal mortality

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Low birthweight

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Intermittent Prophylactic Treatment for malaria

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 3. Two interventions compared
Comparison 4. Combination of interventions versus one intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 ANC coverage: four or more visits Show forest plot

2

Odds Ratio (Random, 95% CI)

0.99 [0.70, 1.40]

2 Pregnancy‐related deaths Show forest plot

2

Odds Ratio (Random, 95% CI)

1.00 [0.52, 1.96]

3 ANC coverage: one or more visits Show forest plot

3

Odds Ratio (Random, 95% CI)

0.86 [0.61, 1.20]

4 Deliveries in a health facility Show forest plot

3

Odds Ratio (Random, 95% CI)

0.95 [0.69, 1.30]

5 Perinatal mortality Show forest plot

2

Odds Ratio (Random, 95% CI)

0.88 [0.72, 1.07]

6 Proportion of women with tetanus protection at birth Show forest plot

2

Odds Ratio (Random, 95% CI)

1.07 [0.80, 1.43]

7 Low birthweight

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Intermittent Prophylactic Treatment for malaria

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 4. Combination of interventions versus one intervention
Comparison 5. Different combinations of interventions

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 ANC coverage: four or more visits Show forest plot

1

383

Odds Ratio (M‐H, Random, 95% CI)

0.77 [0.41, 1.43]

2 Pregnancy‐related deaths

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 ANC coverage: one or more visits

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Deliveries in a health facility Show forest plot

1

383

Odds Ratio (M‐H, Random, 95% CI)

1.55 [0.71, 3.37]

5 Perinatal mortality

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Low birthweight

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Intermittent Prophylactic Treatment for malaria

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 5. Different combinations of interventions
Comparison 6. Subgroup analysis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Health systems vs Population ANC coverage: four or more visits Show forest plot

9

Odds Ratio (Random, 95% CI)

Subtotals only

1.1 Health system interventions

5

Odds Ratio (Random, 95% CI)

1.13 [0.96, 1.34]

1.2 Population interventions

4

Odds Ratio (Random, 95% CI)

1.04 [0.96, 1.13]

2 Health systems vs Population Pregnancy‐related deaths Show forest plot

11

Odds Ratio (Random, 95% CI)

Subtotals only

2.1 Health system interventions

4

Odds Ratio (Random, 95% CI)

1.22 [0.41, 3.65]

2.2 Population intervention

7

Odds Ratio (Random, 95% CI)

0.69 [0.46, 1.03]

3 Country Income Low vs High ANC at least 4 visits Show forest plot

18

Odds Ratio (Random, 95% CI)

1.14 [1.04, 1.25]

3.1 Low or lower middle income countries

11

Odds Ratio (Random, 95% CI)

1.21 [1.04, 1.40]

3.2 High or higher middle income countries

7

Odds Ratio (Random, 95% CI)

1.12 [0.95, 1.32]

Figuras y tablas -
Comparison 6. Subgroup analysis
Comparison 7. One intervention versus no intervention ‐ Sensitivity analysis by risk of bias

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 ANC coverage: four or more visits Show forest plot

9

Odds Ratio (Random, 95% CI)

Subtotals only

1.1 Primary analysis (ICC 0.02 for studies Kirkwood and Morris)

9

Odds Ratio (Random, 95% CI)

1.07 [0.99, 1.15]

1.2 Sensitivity analysis using ICC 0.08

9

Odds Ratio (Random, 95% CI)

1.05 [0.98, 1.14]

Figuras y tablas -
Comparison 7. One intervention versus no intervention ‐ Sensitivity analysis by risk of bias
Comparison 8. Combination of interventions versus no intervention ‐ Sensitivity analysis by risk of bias

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 ANC coverage: four or more visits Show forest plot

4

Odds Ratio (Random, 95% CI)

Subtotals only

1.1 Primary analysis (ICC 0.02 for studies Bhutta and Morris)

4

Odds Ratio (Random, 95% CI)

1.07 [0.82, 1.40]

1.2 ICC 0.08

4

Odds Ratio (Random, 95% CI)

1.03 [0.77, 1.37]

Figuras y tablas -
Comparison 8. Combination of interventions versus no intervention ‐ Sensitivity analysis by risk of bias