Scolaris Content Display Scolaris Content Display

Bolo obligatorio automatizado versus infusión basal para el mantenimiento de la analgesia epidural durante el trabajo de parto

Esta versión no es la más reciente

Appendices

Appendix 1. Search strategies

CENTRAL (the Cochrane Library) search strategy

#1 MeSH descriptor: [labour, Obstetric] explode all trees
#2 MeSH descriptor: [labour Pain] explode all trees
#3 MeSH descriptor: [Delivery, Obstetric] explode all trees
#4 MeSH descriptor: [Parturition] explode all trees
#5 (labo?r near (obstetric or pain* or vaginal)) or (labo?r or parturient* or child?birth or obstet* or deliver*):ti,ab
#6 #1 or #2 or #3 or #4 or #5
#7 MeSH descriptor: [Analgesia, Epidural] explode all trees
#8 MeSH descriptor: [Anesthesia, Epidural] explode all trees
#9 MeSH descriptor: [Infusions, Spinal] explode all trees
#10 MeSH descriptor: [Injections, Spinal] explode all trees
#11 epidural*:ti,ab or (spinal near (infusion* or injection*)):ti,ab or (pain near relief) or (bupivacaine or ropivacaine or mepivacaine or fentanyl or sufentanil)
#12 #7 or #8 or #9 or #10 or #11
#13 bolus* or AMB or basal infusion* or BCI or (intermittent or variable?frequency or patient?controlled):ti,ab
#14 #6 and #12 and #13

OVID MEDLINE search strategy

1 bolus*.mp. or AMB.ti,ab. or basal infusion*.mp. or BCI.ti,ab. or (intermittent or variable?frequency or patient?controlled).ti,ab.
2 exp Analgesia, Epidural/ or exp Anesthesia, Epidural/ or exp Infusions, Spinal/ or exp Injections, Spinal/ or epidural*.ti,ab. or (spinal adj3 (infusion* or injection*)).ti,ab. or (pain adj3 relief).mp. or (bupivacaine or ropivacaine or mepivacaine or fentanyl or sufentanil).mp.
3 exp labour, Obstetric/ or exp labour Pain/ or exp Delivery, Obstetric/ or Parturition/ or (labo?r adj3 (obstetric or pain* or vaginal)).mp. or (labo?r or parturient* or child?birth or obstet* or deliver*).ti,ab.
4 ((randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or clinical trials as topic.sh. or randomly.ab. or trial.ti.) not (animals not (humans and animals)).sh.
5 1 and 2 and 3 and 4

OVID Embase search strategy

1 bolus*.mp. or AMB.ti,ab. or basal infusion*.mp. or BCI.ti,ab. or (intermittent or variable?frequency or patient?controlled).ti,ab.
2 exp epidural anesthesia/ or exp epidural anesthesia/ or exp intraspinal drug administration/ or epidural*.ti,ab. or (spinal adj3 (infusion* or injection*)).ti,ab. or (pain adj3 relief).mp. or (bupivacaine or ropivacaine or mepivacaine or fentanyl or sufentanil).mp.
3 exp labour/ or exp labour pain/ or exp delivery/ or birth/ or (labo?r adj3 (obstetric or pain* or vaginal)).mp. or (labo?r or parturient* or child?birth or obstet* or deliver*).ti,ab.
4 (randomized‐controlled‐trial/ or randomization/ or controlled‐study/ or multicenter‐study/ or phase‐3‐clinical‐trial/ or phase‐4‐clinical‐trial/ or double‐blind‐procedure/ or single‐blind‐procedure/ or (random* or cross?over* or multicenter* or factorial* or placebo* or volunteer*).mp. or ((singl* or doubl* or trebl* or tripl*) adj3 (blind* or mask*)).ti,ab. or (latin adj square).mp.) not (animals not (humans and animals)).sh.
5 1 and 2 and 3 and 4

WHO‐ICTRP

1 (basal infusion OR analgesia OR bolus) AND labor

ClinTrials.gov

1 labor [DISEASE] AND ( "basal infusion" OR bolus ) [TREATMENT] AND EXACT NOT "Male" [GENDER]

Appendix 2. Data collection form

Data collection form

Review title or ID

Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour

Study ID(surname of first author and year first full report of study was published e.g. Smith 2001)

Report IDs of other reports of this study(e.g. duplicate publications, follow‐up studies)

Notes:

1. General information

Date form completed(dd/mm/yyyy)

Name/ID of person extracting data

Report title

(title of paper/abstract/report that data are extracted from)

Report ID

(ID for this paper/abstract/report)

Reference details

Report author contact details

Publication type

(e.g. full report, abstract, letter)

Study funding sources

(including role of funders)

Possible conflicts of interest

(for study authors)

Notes:

2. Study eligibility

Study characteristics

Eligibility criteria

(Insert eligibility criteria for each characteristic as defined in the protocol)

Yes

No

Unclear

Location in text

(pg & ¶/fig/table)

Type of study

Randomized controlled trial

Controlled clinical trial

(quasi‐randomized trial)

Participants

Healthy parturients requesting for epidural analgesia during labour

Types of intervention

Automated mandatory bolus

Basal infusion

Types of outcome measures

1. Risk of breakthrough pain with need for anaesthetic intervention (dichotomous)

2. Risk of caesarean delivery (dichotomous)

3. Risk of instrumental delivery (dichotomous)

4. Duration of labour (continuous)

5. Total dose of local anaesthetic per hour (continuous)

6. Maternal satisfaction (continuous)

7. Apgar scores (continuous)

INCLUDE

EXCLUDE

Reason for exclusion

Notes:

DO NOT PROCEED IF STUDY EXCLUDED FROM REVIEW

3. Population and setting

Description

Include comparative information for each group (i.e. intervention and controls) if available

Location in text

(pg & ¶/fig/table)

Population description

(from which study participants are drawn)

Setting

(including location and social context)

Inclusion criteria

Exclusion criteria

Method/s of recruitment of participants

Informed consent obtained

Yes No Unclear

Notes:

4. Methods

Descriptions as stated in report/paper

Location in text

(pg & ¶/fig/table)

Aim of study

Design(e.g. parallel, cross‐over, cluster)

Unit of allocation

(by individuals, cluster/groups or body parts)

Start date

End date

Total study duration

Ethical approval needed/obtained for study

Yes No Unclear

Notes:

5. 'Risk of bias' assessment

See Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions

Domain

Risk of bias

Support for judgement

Location in text

(pg & ¶/fig/table)

Low risk

High risk

Unclear

Random sequence generation

(selection bias)

Allocation concealment

(selection bias)

Blinding of participants and personnel

(performance bias)

Outcome group: All/

(if required)

Outcome group:

Blinding of outcome assessment

(detection bias)

Outcome group: All/

(if required)

Outcome group:

Incomplete outcome data

(attrition bias)

Selective outcome reporting?

(reporting bias)

Other bias

Notes:

6. Participants

Provide overall data and, if available, comparative data for each intervention or comparison group.

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Total no. randomized

(or total pop. at start of study for NRCTs)

Clusters

(if applicable, no., type, no. people per cluster)

Baseline imbalances

Withdrawals and exclusions

(if not provided below by outcome)

Age

Sex

Race/ethnicity

Severity of illness

Co‐morbidities

Other treatment received(additional to study intervention)

Other relevant sociodemographics

Subgroups measured

Subgroups reported

Notes:

7. Intervention groups

Copy and paste table for each intervention and comparison group

Intervention Group 1

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Group name

No. randomized to group

(specify whether no. people or clusters)

Theoretical basis(include key references)

Description(include sufficient detail for replication, e.g. content, dose, components)

Duration of treatment period

Timing(e.g. frequency, duration of each episode)

Delivery(e.g. mechanism, medium, intensity, fidelity)

Providers

(e.g. no., profession, training, ethnicity etc. if relevant)

Co‐interventions

Economic variables
(i.e. intervention cost, changes in other costs as result of intervention)

Resource requirements to replicate intervention

(e.g. staff numbers, cold chain, equipment)

Notes:

8. Outcomes

Copy and paste table for each outcome.

Outcome 1

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Outcome name

Time points measured

Time points reported

Outcome definition(with diagnostic criteria if relevant)

Person measuring/reporting

Unit of measurement

(if relevant)

Scales: upper and lower limits(indicate whether high or low score is good)

Is outcome/tool validated?

Yes No Unclear

Imputation of missing data
(e.g. assumptions made for ITT analysis)

Assumed risk estimate

(e.g. baseline or population risk noted in Background)

Power

Notes:

9. Results

Copy and paste the appropriate table for each outcome, including additional tables for each time point and subgroup as required.

Dichotomous outcome

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Comparison

Outcome

Subgroup

Time point
(specify whether from start or end of intervention)

Results

Intervention

Comparison

No. events

No. participants

No. events

No. participants

No. missing participants and reasons

No. participants moved from other group and reasons

Any other results reported

Unit of analysis(by individuals, cluster/groups or body parts)

Statistical methods used and appropriateness of these methods(e.g. adjustment for correlation)

Reanalysis required?(specify)

Yes No Unclear

Reanalysis possible?

Yes No Unclear

Reanalysed results

Notes:

Continuous outcome

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Comparison

Outcome

Subgroup

Time point
(specify whether from start or end of intervention)

Post‐intervention or change from baseline?

Results

Intervention

Comparison

Mean

SD (or other variance)

No. participants

Mean

SD (or other variance)

No. participants

No. missing participants and reasons

No. participants moved from other group and reasons

Any other results reported

Unit of analysis

(individuals, cluster/groups or body parts)

Statistical methods used and appropriateness of these methods(e.g. adjustment for correlation)

Reanalysis required?(specify)

Yes No Unclear

Reanalysis possible?

Yes No Unclear

Reanalysed results

Notes:

Other outcome

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Comparison

Outcome

Subgroup

Time point
(specify whether from start or end of intervention)

Results

Intervention result

SD (or other variance)

Control result

SD (or other variance)

Overall results

SE (or other variance)

No. participants

Intervention

Control

No. missing participants and reasons

No. participants moved from other group and reasons

Any other results reported

Unit of analysis(by individuals, cluster/groups or body parts)

Statistical methods used and appropriateness of these methods

Reanalysis required?(specify)

Yes No Unclear

Reanalysis possible?

Yes No Unclear

Reanalysed results

Notes:

10. Applicability

Have important populations been excluded from the study?(consider disadvantaged populations, and possible differences in the intervention effect)

Yes No Unclear

Is the intervention likely to be aimed at disadvantaged groups?(e.g. lower socioeconomic groups)

Yes No Unclear

Does the study directly address the review question?

(any issues of partial or indirect applicability)

Yes No Unclear

Notes:

11. Other information

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Key conclusions of study authors

References to other relevant studies

Correspondence required for further study information(from whom, what and when)

Notes:

Appendix 3. Cochrane 'Risk of bias' tool and criteria for judgment

1. Random sequence generation (checking for possible selection bias)

We described for each included study the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.

We assessed the method as being at:

  1. low risk of bias (any truly random process, e.g. random number table; computer random number generator);

  2. high risk of bias (any non‐random process, e.g. odd or even date of birth; hospital or clinic record number);

  3. unclear risk of bias.

2. Allocation concealment (checking for possible selection bias)

We described for each included study the method used to conceal allocation to interventions prior to assignment and will assess whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.

We assessed the methods as being at:

  1. low risk of bias (e.g. telephone or central randomization; consecutively numbered sealed opaque envelopes);

  2. high risk of bias (open random allocation; unsealed or non‐opaque envelopes, alternation; date of birth);

  3. unclear risk of bias.

3. Blinding

3.1 Blinding of participants and personnel (checking for possible performance bias)

We described for each included study the methods used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. We considered that studies were at low risk of bias if they were blinded, or if we judged that the lack of blinding would be unlikely to affect results. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed the methods as being at:

  1. low, high or unclear risk of bias for participants;

  2. low, high or unclear risk of bias for personnel.

3.2 Blinding of outcome assessment (checking for possible detection bias)

We described for each included study the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed methods used to blind outcome assessment as being at:

  1. low, high or unclear risk of bias.

4. Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)

We described for each included study, and for each outcome or class of outcomes, the completeness of data including attrition and exclusions from the analysis. We stated whether attrition and exclusions were reported and the numbers included in the analysis at each stage (compared with the total randomized participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information is reported, or could be supplied by the trial authors, we re‐included missing data in the analyses which we undertook.

We assessed methods as being at:

  1. low risk of bias (e.g. no missing outcome data; missing outcome data balanced across groups);

  2. high risk of bias (e.g. numbers or reasons for missing data imbalanced across groups; 'as treated' analysis done with substantial departure of intervention received from that assigned at randomization);

  3. unclear risk of bias.

5. Selective reporting (checking for reporting bias)

We described for each included study how we investigated the possibility of selective outcome reporting bias and what we found.

We assessed the methods as being at:

  1. low risk of bias (where it is clear that all of the study's pre‐specified outcomes and all expected outcomes of interest to the review have been reported);

  2. high risk of bias (where not all the study's pre‐specified outcomes have been reported; one or more reported primary outcomes were not pre‐specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported);

  3. unclear risk of bias.

6. Other bias (checking for bias due to problems not covered by 1 to 5 above)

We described for each included study any important concerns we had about other possible sources of bias.

7. Overall risk of bias

We made explicit judgements about whether studies are at high risk of bias, according to the criteria given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). With reference to items 1 to 6 above, we assessed the likely magnitude and direction of the bias and whether we considered it likely to impact on the findings. We planned to explore the impact of the level of bias through undertaking sensitivity analyses ‐ see Sensitivity analysis.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

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

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 3

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

Funnel plot of comparison: 1 Automated mandatory bolus vs basal infusion, outcome: 1.2 Breakthrough pain (epidural vs CSE).
Figuras y tablas -
Figure 4

Funnel plot of comparison: 1 Automated mandatory bolus vs basal infusion, outcome: 1.2 Breakthrough pain (epidural vs CSE).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 1 Breakthrough pain.
Figuras y tablas -
Analysis 1.1

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 1 Breakthrough pain.

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 2 Breakthrough pain (epidural vs CSE).
Figuras y tablas -
Analysis 1.2

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 2 Breakthrough pain (epidural vs CSE).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 3 Breakthrough pain (PCEA vs no PCEA).
Figuras y tablas -
Analysis 1.3

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 3 Breakthrough pain (PCEA vs no PCEA).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 4 Breakthrough pain (nulliparous vs multiparous).
Figuras y tablas -
Analysis 1.4

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 4 Breakthrough pain (nulliparous vs multiparous).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 5 Caesarean delivery.
Figuras y tablas -
Analysis 1.5

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 5 Caesarean delivery.

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 6 Caesarean delivery (LA + opioids vs LA alone).
Figuras y tablas -
Analysis 1.6

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 6 Caesarean delivery (LA + opioids vs LA alone).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 7 Caesarean delivery (epidural vs CSE).
Figuras y tablas -
Analysis 1.7

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 7 Caesarean delivery (epidural vs CSE).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 8 Caesarean delivery (PCEA vs no PCEA).
Figuras y tablas -
Analysis 1.8

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 8 Caesarean delivery (PCEA vs no PCEA).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 9 Caesarean delivery (nulliparous vs multiparous).
Figuras y tablas -
Analysis 1.9

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 9 Caesarean delivery (nulliparous vs multiparous).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 10 Instrumental delivery.
Figuras y tablas -
Analysis 1.10

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 10 Instrumental delivery.

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 11 Instrumental delivery (LA + opioids vs LA alone).
Figuras y tablas -
Analysis 1.11

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 11 Instrumental delivery (LA + opioids vs LA alone).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 12 Instrumental delivery (epidural vs CSE).
Figuras y tablas -
Analysis 1.12

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 12 Instrumental delivery (epidural vs CSE).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 13 Instrumental delivery (PCEA vs No PCEA).
Figuras y tablas -
Analysis 1.13

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 13 Instrumental delivery (PCEA vs No PCEA).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 14 Instrumental delivery (nulliparous vs multiparous).
Figuras y tablas -
Analysis 1.14

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 14 Instrumental delivery (nulliparous vs multiparous).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 15 Duration of labour in minutes.
Figuras y tablas -
Analysis 1.15

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 15 Duration of labour in minutes.

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 16 Duration of labour in minutes (LA + opioids vs LA alone).
Figuras y tablas -
Analysis 1.16

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 16 Duration of labour in minutes (LA + opioids vs LA alone).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 17 Duration of labour in minutes (epidural vs CSE).
Figuras y tablas -
Analysis 1.17

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 17 Duration of labour in minutes (epidural vs CSE).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 18 Duration of labour in minutes (PCEA vs no PCEA).
Figuras y tablas -
Analysis 1.18

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 18 Duration of labour in minutes (PCEA vs no PCEA).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 19 Duration of labour in minutes (nulliparous vs multiparous).
Figuras y tablas -
Analysis 1.19

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 19 Duration of labour in minutes (nulliparous vs multiparous).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 20 LA consumption per hour.
Figuras y tablas -
Analysis 1.20

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 20 LA consumption per hour.

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 21 LA consumption per hour (LA + opioids vs LA alone).
Figuras y tablas -
Analysis 1.21

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 21 LA consumption per hour (LA + opioids vs LA alone).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 22 LA consumption per hour (epidural vs CSE).
Figuras y tablas -
Analysis 1.22

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 22 LA consumption per hour (epidural vs CSE).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 23 LA consumption per hour (PCEA vs no PCEA).
Figuras y tablas -
Analysis 1.23

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 23 LA consumption per hour (PCEA vs no PCEA).

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 24 LA consumption per hour (nulliparous vs multiparous).
Figuras y tablas -
Analysis 1.24

Comparison 1 Automated mandatory bolus vs basal infusion, Outcome 24 LA consumption per hour (nulliparous vs multiparous).

Summary of findings for the main comparison. Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour

Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour

Patient or population: maintenance of epidural analgesia in labour
Setting: patients admitted into the labour ward
Intervention: automated mandatory bolus
Comparison: basal infusion

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Risk with basal infusion

Risk with automated mandatory bolus

Breakthrough pain
assessed with: verbal patient reporting or need for rescue analgesia
Follow‐up: range 242 min to 490 min

Study population

RR 0.60
(0.39 to 0.92)

797
(10 RCTs)

⊕⊕⊕⊝
Moderatea

333 per 1000

200 per 1000
(130 to 307)

Caesarean delivery
Follow‐up: range 242 min to 490 min

Study population

RR 0.92
(0.70 to 1.21)

1079
(11 RCTs)

⊕⊕⊝⊝
Lowb

160 per 1000

147 per 1000
(112 to 194)

Instrumental delivery
Follow‐up: range 242 min to 490 min

Study population

RR 0.75
(0.54 to 1.06)

1079
(11 RCTs)

⊕⊕⊝⊝
Lowb

123 per 1000

92 per 1000
(66 to 130)

Duration of labour in min
Follow‐up: range 242 min to 490 min

The mean duration of labour in min ranged from 186.3 to 690.0 min

MD 10.38 min lower
(26.73 lower to 5.96 higher)

1079
(11 RCTs)

⊕⊕⊕⊝
Moderatec

LA consumption per hour
Follow‐up: range 242 min to 490 min

The mean LA consumption per hour ranged from 3 mg to 21.4 mg

MD 1.08 mg/h lower
(1.78 lower to 0.38 lower)

1121
(12 RCTs)

⊕⊕⊕⊝
Moderated

*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; MD: mean difference; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: 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 certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

aDowngraded one level due to considerable statistical heterogeneity for this outcome, i.e. I2 = 69%.
bDowngraded two levels because the upper and lower confidence limit cross the effect size of 5% in either direction and there is inadequate information given the small numbers.
cDowngraded one level because the upper and lower confidence limit cross the effect size of 0.5 in either direction.
dDowngraded one level due to considerable statistical inconsistency for this outcome, i.e. I2 = 89%.

Figuras y tablas -
Summary of findings for the main comparison. Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour
Comparison 1. Automated mandatory bolus vs basal infusion

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Breakthrough pain Show forest plot

10

797

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.39, 0.92]

2 Breakthrough pain (epidural vs CSE) Show forest plot

10

797

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.39, 0.92]

2.1 Epidural

3

313

Risk Ratio (M‐H, Random, 95% CI)

0.40 [0.25, 0.64]

2.2 CSE

7

484

Risk Ratio (M‐H, Random, 95% CI)

0.71 [0.44, 1.13]

3 Breakthrough pain (PCEA vs no PCEA) Show forest plot

10

797

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.39, 0.92]

3.1 PCEA

5

477

Risk Ratio (M‐H, Random, 95% CI)

0.61 [0.35, 1.07]

3.2 No PCEA

5

320

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.30, 1.12]

4 Breakthrough pain (nulliparous vs multiparous) Show forest plot

9

669

Risk Ratio (M‐H, Random, 95% CI)

0.62 [0.39, 1.00]

4.1 Nulliparous

8

543

Risk Ratio (M‐H, Random, 95% CI)

0.62 [0.33, 1.15]

4.2 Multiparous

1

126

Risk Ratio (M‐H, Random, 95% CI)

0.59 [0.38, 0.90]

5 Caesarean delivery Show forest plot

11

1079

Risk Ratio (M‐H, Random, 95% CI)

0.92 [0.70, 1.21]

6 Caesarean delivery (LA + opioids vs LA alone) Show forest plot

11

1079

Risk Ratio (M‐H, Random, 95% CI)

0.92 [0.70, 1.21]

6.1 LA + opioids

10

952

Risk Ratio (M‐H, Random, 95% CI)

0.93 [0.70, 1.24]

6.2 LA alone

1

127

Risk Ratio (M‐H, Random, 95% CI)

0.74 [0.27, 2.01]

7 Caesarean delivery (epidural vs CSE) Show forest plot

11

1079

Risk Ratio (M‐H, Random, 95% CI)

0.92 [0.70, 1.21]

7.1 Epidural

5

637

Risk Ratio (M‐H, Random, 95% CI)

0.78 [0.53, 1.15]

7.2 CSE

6

442

Risk Ratio (M‐H, Random, 95% CI)

1.08 [0.73, 1.59]

8 Caesarean delivery (PCEA vs no PCEA) Show forest plot

11

1079

Risk Ratio (M‐H, Random, 95% CI)

0.92 [0.70, 1.21]

8.1 PCEA

7

801

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.70, 1.37]

8.2 No PCEA

4

278

Risk Ratio (M‐H, Random, 95% CI)

0.81 [0.50, 1.30]

9 Caesarean delivery (nulliparous vs multiparous) Show forest plot

10

951

Risk Ratio (M‐H, Random, 95% CI)

0.93 [0.70, 1.25]

9.1 Nulliparous

9

825

Risk Ratio (M‐H, Random, 95% CI)

0.92 [0.69, 1.23]

9.2 Multiparous

1

126

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.27]

10 Instrumental delivery Show forest plot

11

1079

Risk Ratio (M‐H, Random, 95% CI)

0.75 [0.54, 1.06]

11 Instrumental delivery (LA + opioids vs LA alone) Show forest plot

11

1079

Risk Ratio (M‐H, Random, 95% CI)

0.80 [0.57, 1.12]

11.1 LA + opioids

10

952

Risk Ratio (M‐H, Random, 95% CI)

0.77 [0.54, 1.08]

11.2 LA alone

1

127

Risk Ratio (M‐H, Random, 95% CI)

1.97 [0.37, 10.37]

12 Instrumental delivery (epidural vs CSE) Show forest plot

11

1079

Risk Ratio (M‐H, Random, 95% CI)

0.80 [0.57, 1.12]

12.1 Epidural

5

637

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.53, 1.74]

12.2 CSE

6

442

Risk Ratio (M‐H, Random, 95% CI)

0.59 [0.33, 1.05]

13 Instrumental delivery (PCEA vs No PCEA) Show forest plot

11

1079

Risk Ratio (M‐H, Random, 95% CI)

0.80 [0.57, 1.12]

13.1 No PCEA

4

278

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.60, 1.61]

13.2 PCEA

7

801

Risk Ratio (M‐H, Random, 95% CI)

0.67 [0.42, 1.05]

14 Instrumental delivery (nulliparous vs multiparous) Show forest plot

10

951

Risk Ratio (M‐H, Random, 95% CI)

0.76 [0.54, 1.07]

14.1 Nulliparous

9

825

Risk Ratio (M‐H, Random, 95% CI)

0.76 [0.53, 1.08]

14.2 Multiparous

1

126

Risk Ratio (M‐H, Random, 95% CI)

0.75 [0.17, 3.22]

15 Duration of labour in minutes Show forest plot

11

1079

Mean Difference (IV, Random, 95% CI)

‐10.38 [‐26.73, 5.96]

16 Duration of labour in minutes (LA + opioids vs LA alone) Show forest plot

11

1079

Mean Difference (IV, Random, 95% CI)

‐10.38 [‐26.73, 5.96]

16.1 LA + opioids

10

952

Mean Difference (IV, Random, 95% CI)

‐12.52 [‐31.87, 6.82]

16.2 Duration of labor in minutes (LA alone)

1

127

Mean Difference (IV, Random, 95% CI)

0.0 [‐36.63, 36.63]

17 Duration of labour in minutes (epidural vs CSE) Show forest plot

11

1079

Mean Difference (IV, Random, 95% CI)

‐10.38 [‐26.73, 5.96]

17.1 Epidural

5

637

Mean Difference (IV, Random, 95% CI)

‐3.04 [‐26.42, 20.34]

17.2 CSE

6

442

Mean Difference (IV, Random, 95% CI)

‐32.70 [‐65.20, ‐0.20]

18 Duration of labour in minutes (PCEA vs no PCEA) Show forest plot

11

1079

Mean Difference (IV, Random, 95% CI)

‐10.38 [‐26.73, 5.96]

18.1 PCEA

7

801

Mean Difference (IV, Random, 95% CI)

‐13.24 [‐20.71, ‐5.76]

18.2 No PCEA

4

278

Mean Difference (IV, Random, 95% CI)

‐48.65 [‐129.92, 32.62]

19 Duration of labour in minutes (nulliparous vs multiparous) Show forest plot

10

951

Mean Difference (IV, Random, 95% CI)

‐14.38 [‐21.80, ‐6.96]

19.1 Nulliparous

9

825

Mean Difference (IV, Random, 95% CI)

‐13.92 [‐23.75, ‐4.10]

19.2 Multiparous

1

126

Mean Difference (IV, Random, 95% CI)

‐28.0 [‐76.95, 20.95]

20 LA consumption per hour Show forest plot

12

1121

Mean Difference (IV, Random, 95% CI)

‐1.08 [‐1.78, ‐0.38]

21 LA consumption per hour (LA + opioids vs LA alone) Show forest plot

12

1121

Mean Difference (IV, Random, 95% CI)

‐1.08 [‐1.78, ‐0.38]

21.1 LA + opioids

11

994

Mean Difference (IV, Random, 95% CI)

‐0.75 [‐1.35, ‐0.15]

21.2 LA alone

1

127

Mean Difference (IV, Random, 95% CI)

‐9.50 [‐12.55, ‐6.45]

22 LA consumption per hour (epidural vs CSE) Show forest plot

12

1121

Mean Difference (IV, Random, 95% CI)

‐1.08 [‐1.78, ‐0.38]

22.1 Epidural

5

637

Mean Difference (IV, Random, 95% CI)

‐2.59 [‐4.13, ‐1.05]

22.2 CSE

7

484

Mean Difference (IV, Random, 95% CI)

‐0.35 [‐0.80, 0.11]

23 LA consumption per hour (PCEA vs no PCEA) Show forest plot

12

1121

Mean Difference (IV, Random, 95% CI)

‐1.08 [‐1.78, ‐0.38]

23.1 PCEA

7

801

Mean Difference (IV, Random, 95% CI)

‐1.59 [‐2.58, ‐0.60]

23.2 No PCEA

5

320

Mean Difference (IV, Random, 95% CI)

‐0.53 [‐1.58, 0.52]

24 LA consumption per hour (nulliparous vs multiparous) Show forest plot

11

993

Mean Difference (IV, Random, 95% CI)

‐0.89 [‐1.55, ‐0.23]

24.1 Nulliparous

10

867

Mean Difference (IV, Random, 95% CI)

‐0.83 [‐1.51, ‐0.15]

24.2 Multiparous

1

126

Mean Difference (IV, Random, 95% CI)

‐1.80 [‐3.93, 0.33]

Figuras y tablas -
Comparison 1. Automated mandatory bolus vs basal infusion