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.
To review the evidence of the effectiveness and safety of abortion procedures administered by MLPs versus doctors.
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
- 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).
- 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).
No secondary outcomes.
Search methods for identification of studies
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.
- Study methods.
- Study outcomes.
- Study results.
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.
- Selection bias.
- Performance bias.
- Detection bias.
- Attrition bias.
- Reporting bias.
- 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 Chi
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).
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.
- Type of MLP.
- Type of abortion service given.
- Healthcare setting (community level, primary or secondary level healthcare facility)
Where possible, we will carry out sensitivity analysis to explore the impact of outcome reporting bias.
This protocol was reviewed by three editors of the Cochrane Fertility Regulation Group as part of the peer review process.
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
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
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
- Marie Stopes International, UK.Funding of the study and administrative support
- David Geffen School of Medicine UCLA, USA.Provision of literature