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Intervention Protocol

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Doctors or mid-level providers for abortion

  1. Sharmani Barnard1,*,
  2. Caron Kim2,
  3. Min Hae Park3,
  4. Thoai D Ngo1

Editorial Group: Cochrane Fertility Regulation Group

Published Online: 31 JUL 2014

DOI: 10.1002/14651858.CD011242


How to Cite

Barnard S, Kim C, Park MH, Ngo TD. Doctors or mid-level providers for abortion (Protocol). Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No.: CD011242. DOI: 10.1002/14651858.CD011242.

Author Information

  1. 1

    Marie Stopes International, Research Monitoring and Evaluation, London, UK

  2. 2

    David Geffen School of Medicine UCLA, Department of Obstetrics & Gynecology, Los Angeles, USA

  3. 3

    London School of Hygiene & Tropical Medicine, London, UK

*Sharmani Barnard, Research Monitoring and Evaluation, Marie Stopes International, 1 Conway Street, 4 Fitzroy Square, London, W1T 6LP, UK. sharmani.barnard@mariestopes.org.

Publication History

  1. Publication Status: New
  2. Published Online: 31 JUL 2014

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This is not the most recent version of the article. View current version (27 JUL 2015)

 

Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Description of the condition

Unsafe abortion remains a major public health concern in developing countries. Despite the existence of safe and effective surgical (Kulier 2009) and medical (Kulier 2011) methods to induce abortion, an estimated 22 million unsafe abortions are performed each year (Sedgh 2012). The majority of unsafe abortions occur in developing countries and resultin the deaths of 47,000 women and disabilities for an additional 5 million women (Sedgh 2012). Most of these deaths and disabilities could be prevented through the provision of safe and legal induced abortion by qualified providers.

To ensure that women living in developing countries can readily access safe abortion services, the World Health Organization (WHO) recommends that abortion can be provided at the lowest level of the healthcare system (WHO 2012). However, in many developing countries, even in settings where abortion is legal, access to abortion remains limited due to a shortage of trained physicians. Irrespective of legal conditions, in settings where access to safe abortion care is lacking, women often obtain termination services from unqualified or unskilled providers (WHO 2012). Therefore, training midlevel providers (MLPs – midwives, nurses, and other non-physician providers) to conduct first trimester aspiration abortions and manage medical abortions has been proposed as a way to increase women’s access to safe abortion services (Berer 2009).

 

Description of the intervention

In order to address the shortage of human resources for abortion services, the use of MLPs in providing abortion has been used in a number of settings. MLPs are midwifes or any other healthcare worker who has less training than a doctor, but performs aspects of doctors’ tasks.

 

How the intervention might work

Authorising and training MLPs to provide abortion could reduce the number of unsafe procedures and alleviate burden on the healthcaresystem. A review of medical abortion service delivery suggests that the provision and management of medical abortion by MLPs is cost-effective in resource-limited settings due to the salary costs and scarcity of physicians (Berer 2009). However, only a few countries across the world adopt this practice. In developed settings, including France and the UK (Jones 2000), nurses and midwives are not permitted to manage and administer abortion procedures independently. Only a handful of countries in the developing world permit midwives to perform surgical abortion (Cambodia (Long 2001), South Africa, and Vietnam) or paramedics to carry out “menstrual regulation” procedures (Bangladesh). In these countries, national policies limit access to medical abortion by restricting its prescription and provision to certified physicians (Yarnall 2009).

 

Why it is important to do this review

Training MLPs to conduct surgical abortions and manage medical abortions has been proposed as a way to increase women’s access to safe abortion. Restrictions on midlevel provision are mainly due to concerns about the standard of care and safety of abortions provided by MLPs. In order to inform access to safe abortion, we will review the evidence on the effectiveness and safety of abortion procedures performed by MLPs compared with doctors.

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

To review the evidence of the effectiveness and safety of abortion procedures administered by MLPs versus doctors.

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Criteria for considering studies for this review

 

Types of studies

We will review published studies assessing the effectiveness, or safety, or both, of abortion provided by MLPs compared with procedures provided by doctors. For the purposes of this review, MLPs will be defined as all trained health professionals who are not physicians.

We will include randomised controlled trials (RCTs), non-RCTs, controlled before-after (CBA) studies and interrupted time series (ITS) studies. We will also include cluster-RCTs. We will not apply any language or publication status restrictions.

 

Types of participants

Participants of interest are women in any setting who are seeking abortion services.

 

Types of interventions

Any type of abortion service provided by either doctors or MLPs in any country, in any setting.

 

Types of outcome measures

 

Primary outcomes

  1. Measures of effectiveness or efficacy of abortion procedures provided by MLPs compared with doctors (for the purposes of analysis, incomplete or failed abortion are the main outcomes).
  2. Measures of safety of abortion procedures administered by MLPs versus doctors, namely adverse events and complications (excess bleeding, cervical injury, uterine perforation, adverse drug reactions, retained products of conception, haematometra, pelvic infection, excessive postabortion bleeding, and abortion-related death).

 

Secondary outcomes

No secondary outcomes.

 

Search methods for identification of studies

 

Electronic searches

We will search the following electronic databases:

Cochrane Central Register of Controlled Trials (CENTRAL)
MEDLINE using OVID
EMBASE using OVIDPOPLINEWe will search for recent clinical trials separately via the following databases: clinical trials registry at the WHO International Clinical Trials Registry Platform (www.who.int/trialsearch), "ClinicalTrials.gov", the search portal of the International Clinical Trials Registry Platform (ICTRP), and Current Controlled Trials (www.controlled-trials.com).We will search for studies published in all languages since January 1980 until present . The strategy for MEDLINE (Ovid) is presented in Appendix 1 and will be adapted to the above databases. If additional key words of relevance are identified during any of the searches, electronic search strategies will be modified to incorporate these terms in agreement with the Cochrane review co-ordinating editor.

 

Searching other resources

We will handsearch grey literature and other relevant publications for further studies.

 

Data collection and analysis

 

Selection of studies

Two review authors (SB. CK.) will screen titles and abstracts of studies for inclusion. We will retrieve the full text of potentially eligible studies for screening and independently apply the inclusion criteria to the retrieved publications. Inter-rater agreement will be assessed using a kappa coefficient. We will discuss any disagreements about the inclusion of studies and if no consensus can be met, we will consult the contact editor for the review. We will seek further information from the study authors where papers contain insufficient information to make a decision about eligibility. A PRISMA flowchart detailing the search and selection process will be included in the review.

 

Data extraction and management

We will double extract data using a predesigned standard form. Both review authors (SB. CK.) will independently extract all outcome data. We will then check the data against each other and, if necessary, we will make reference to the original paper. We will resolve any outstanding discrepancies by consensus between the two data extraction sheets. We will also contact study authors to obtain any missing information. We will extract data relating to the following from all the included studies.

  1. Study methods.
  2. Participants.
  3. Interventions.
  4. Study outcomes.
  5. Study results.
  6. Miscellaneous.

 

Assessment of risk of bias in included studies

We will assess studies for methodological quality using a predesigned standard form as 'low risk', 'unclear risk' or 'high risk' of bias for each domain (Higgins 2011). We will judge bias according to the following domains.

  1. Selection bias.
  2. Performance bias.
  3. Detection bias.
  4. Attrition bias.
  5. Reporting bias.
  6. Other bias.

Both authors (SB.CK.) will independently assess the studies for quality. We will discuss any disagreements and if no consensus can be met, we will consult the other authors (MHP. TN.). Risk of bias will be discussed when interpreting the results of the review.

 

Measures of treatment effect

We will record and report measures of effect in the same way that the investigators have reported them. We will assess whether different measures of effect can be combined.

 

Unit of analysis issues

For all included studies, we will assess whether an appropriate analysis has been done that adjusts for clustering in calculating measures of precision. If this has not been done, we will attempt to extract necessary data using intra-cluster correlation (ICC) coefficients or obtain these from the investigators, and reanalyse the results. If this is not possible, we will apply an ICC from a similar study in the review.

 

Dealing with missing data

For included studies, we will note levels of attrition. We will attempt to obtain missing data from the investigators. If this is not possible, we will report the data as missing and will not attempt to impute values.

 

Assessment of heterogeneity

We will determine clinical heterogeneity and wherever possible, we will assess statistical heterogeneity in each analysis using Chi2 statistics (with a P value < 0.1).

 

Assessment of reporting biases

We will assess selective outcome reporting as a risk of bias criterion, as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

 

Data synthesis

We will carry out data analysis using the computer program Review Manager 5.0 (Revman 5.0).The principal measure of effect will be the risk of incomplete or failed abortion administered by MLPs, relative to the risk of incomplete or failed abortion administered by a physician, and the 95% confidence interval (CI) of this risk ratio (RR).

We will also examine the RR for overall complications, which will be categorised in some of the included studies as either immediate (complications occurring during the procedure or up to discharge from the clinic) or delayed (occurring any time between discharge and follow-up).

 

Subgroup analysis and investigation of heterogeneity

We will perform subgroup analyses on the following factors.

  1. Type of MLP.
  2. Type of abortion service given.
  3. Healthcare setting (community level, primary or secondary level healthcare facility)

 

Sensitivity analysis

Where possible, we will carry out sensitivity analysis to explore the impact of outcome reporting bias.

 

Acknowledgements

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

This protocol was reviewed by three editors of the Cochrane Fertility Regulation Group as part of the peer review process.

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Appendix 1. Medline Search Strategy

((("Nurses"[Mesh] OR "Physician Assistants"[Mesh] OR "mid-level provider"[text word] OR "mid-level providers"[text word] OR nurse*[text word] OR midwife*[text word] OR midwives[text word] OR "nurse practitioner"[text word] OR "nurse practitioners"[text word] OR "physician assistant"[text word] OR "physician assistants"[text word] OR "non-physician"[text word] OR "non-physicians"[text word] OR "substitute health worker"[text word] OR "substitute health workers"[text word] OR auxiliar*[text word]) AND ("Abortion, Incomplete"[Mesh] OR "Abortion, Induced"[Mesh:noexp] OR "Abortion, Legal"[Mesh] OR "Abortion, Therapeutic"[Mesh:noexp] OR abortion*[text word]))). Search results will be restricted to studies published after 1980. No limits will be placed on language.

 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

Draft the protocol: Sharmani Barnard (SB), Caron Kim (CK).
Study selection: SB, CK.
Extract data from studies: SB, CK.
Enter data into Review Manager: SB, CK.
Carry out the analysis: SB, CK.
Interpret the analysis: SB, CK, Min Hae Park (MHP), Thoai Ngo (TN).
Draft the final review: SB, CK.
Disagreement resolution: MHP, TN.
Update the review SB, CK.

 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

Sharmani Barnard: nothing to declare

Caron Kim: nothing to declare

Min Hae Park: nothing to declare

Thoai D. Ngo: nothing to declare

 

Sources of support

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Internal sources

  • Marie Stopes International, UK.
    Funding of the study and administrative support

 

External sources

  • David Geffen School of Medicine UCLA, USA.
    Provision of literature

References

Additional references

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Acknowledgements
  7. Appendices
  8. Contributions of authors
  9. Declarations of interest
  10. Sources of support
  11. Additional references
  12. References to other published versions of this review
Berer 2009
Higgins 2011
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
Jones 2000
  • Jones RK, Henshaw SK. Mifepristone for early medical abortion: experiences in France, Great Britain and Sweden. Perspectives on Sexual and Reproductive Health 2000;34(3):154-61.
Kulier 2009
  • Kulier R, Cheng L, Fekih A, Hofmeyr GJ, Campana A. Surgical methods for first trimester termination of pregnancy. Cochrane Database of Systematic Reviews 2009, Issue 3. [DOI: 10.1002/14651858.CD002900]
Kulier 2011
Long 2001
  • Long C, Ren N. Abortion in Cambodia: Country Report. Expanding Access: Midlevel Providers in Menstrual Regulation and Elective Abortion Care; 2001 Dec 3-6; South Africa. 2001.
Revman 5.0
  • The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.0. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008.
Sedgh 2012
WHO 2012
  • World Health Organization, Department of Reproductive Health and Research. Safe abortion: Technical and Policy Guidance for Health Systems. 2nd Edition. Geneva: World Health Organization, 2012.
Yarnall 2009

References to other published versions of this review

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Acknowledgements
  7. Appendices
  8. Contributions of authors
  9. Declarations of interest
  10. Sources of support
  11. Additional references
  12. References to other published versions of this review
Ngo 2013
  • Ngo TD, Park MH, Free C. Safety and effectiveness of termination services performed by doctors versus midlevel providers: a systematic review and analysis. International Journal of Women's Health 2013;5:9-17.