Intervention Protocol

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Preconception counselling for women with epilepsy

  1. Janine B Winterbottom1,*,
  2. Jennifer Pulman2,
  3. Janette Greenhalgh3,
  4. Rebecca MD Smyth4,
  5. Anthony G Marson2

Editorial Group: Cochrane Epilepsy Group

Published Online: 18 MAR 2014

Assessed as up-to-date: 27 FEB 2014

DOI: 10.1002/14651858.CD011007


How to Cite

Winterbottom JB, Pulman J, Greenhalgh J, Smyth RMD, Marson AG. Preconception counselling for women with epilepsy (Protocol). Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD011007. DOI: 10.1002/14651858.CD011007.

Author Information

  1. 1

    The Walton Centre for Neurology and Neurosurgery, Liverpool, UK

  2. 2

    Institute of Translational Medicine, University of Liverpool, Department of Molecular and Clinical Pharmacology, Liverpool, Merseyside, UK

  3. 3

    University of Liverpool, Liverpool Reviews and Implementation Group, Liverpool, UK

  4. 4

    The University of Manchester, School of Nursing, Midwifery and Social Work, Manchester, UK

*Janine B Winterbottom, The Walton Centre for Neurology and Neurosurgery, Lower Lane, Liverpool, L9 7LJ, UK. janine.winterbottom@thewaltoncentre.nhs.uk. J.B.Winterbottom@liv.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 18 MAR 2014

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Table 1. Risk of bias scale parameters

1 Low risk2345 High risk

ConfoundingAll important1 confounders considered2 and suitable method of adjustment3 employed. Outcome unlikely to be affected.Most important4 confounders considered and suitable method of adjustment employed. Outcome unlikely to be affected.Some confounders5 considered and full or partial adjustment employed.6 Possible implication on outcome.Some confounders considered and no adjustment employed. Likely to affect outcome.No important confounders considered and no adjustment employed. Likely to affect outcome.

BlindingAssessors blinded to participant’s drug regime and/or intervention and participants blinded to drug regime and/or intervention. Outcome unlikely to be affected.Assessors blinded to participants drug regime and/or intervention. Outcome unlikely to be affected.Partial blinding7 involved in study. Possible implication on outcome.Partial or no blinding involved in study. Outcome likely to be affected.No blinding involved in study.  Outcome likely to be affected.

Incomplete outcome dataNo missing data and/or

appropriate analysis8 used to deal with missing data. Unlikely to affect outcome.
Smaller amount (< 25%) of missing data with reasons given, balanced across groups. Unlikely to affect outcome.Larger amount of missing data (> 25%) with or without reasons given, balanced across groups. Possible implication on outcome. Larger amount (> 25%) of missing data, imbalance across groups. Outcome likely to be affected.

 
No information provided regarding missing data. Likely to affect outcome. 

Selective outcome reportingA priori outcomes measured, analysed and reported in main report. Protocol available. Unlikely to affect outcome.A priori outcomes measured, analysed and reported in main report9. Protocol not available. Unlikely to affect outcome.Limited information regardinga priori outcomes and measures. Possible implication on outcome.Outcomes measured but not analysed or reported.Outcomes measured  but not analysed or reported and clinical judgement infers the presence of an unreported measured outcome.10

Other biasNo bias identified.  Bias identified. Unlikely to affect outcome.Bias identified. Possible implication on outcome.Bias identified. Likely to affect outcome.Bias identified. Extremely likely to affect outcome.

 1 Important confounders include patient specific factors (maternal age, parity, previous affected child, maternal IQ, socio-economic status, epilepsy type, seizure exposure, AED use and pre-intervention knowledge of AED and seizure-related pregnancy risks); resources/service specific factors (attendance rate of preconception counselling sessions).
2 Reported demographic information and other confounders.
3 Matching scores, multiple regression, analysis of co-variance, stratification.
4 At least five out of ten of important confounders including maternal educational level or IQ, pre-intervention knowledge of AED and seizure related pregnancy risks and attendance of preconception counselling sessions.
5 At least two out of ten of important confounders.
6 Full adjustment of confounding variables e.g. see footnote 2, or partial adjustment e.g. researchers select limited number of variables to adjust for.
7 Assessors of outcome are only blinded to certain groups e.g. blinded to intervention group but not controls.
8 Intention-to-treat analysis.
9 An a priori statement is made in methods section of main report regarding measurement and analysis of outcome.
10 For example, failure to report full scale IQ when all other indices are reported.