PICO: P = population; I = intervention; C = comparator; O = outcome(s)^[1] 

Note: For a description of all the health worker categories mentioned in this annex, please refer to Annex 5.

Services applicable across the continuum of care

Provision of information

PICO 1: Pharmacy workers to provide accurate information (see Recommendation 4)

PICO question: For a person seeking information about abortion care (before or after treatment/abortion), is information on the availability of safe providers for abortion care (abortion provision, care for complications of abortion, care for incomplete abortion) provided by a pharmacy worker a safe, effective and satisfactory/acceptable alternative to no provision of information (usual practice)?

P: Person seeking information about abortion care before their treatment, or following an incomplete abortion or complications of abortion (including medical or surgical, at any gestational age)

I: Information and linkage to abortion services, in the community or in other locations, by pharmacy workers

C: No information (usual practice)

O:

• Effectiveness (pharmacy workers’ correct knowledge of safe abortion and possible complications, of safe post-abortion care, and of indications for referral)
• Privacy and confidentiality in provision of information
• Accessibility of the services for the person who requires them
• Satisfaction with/acceptability of the information and services provided.

Counselling

PICO 2: Pre- and post-abortion counselling (see Recommendation 5)

PICO question: For a pregnant person having an abortion, is pre- and post-abortion counselling provided by a traditional and complementary medicine professional, pharmacist, pharmacy worker or community health worker a safe, effective and satisfactory/acceptable alternative to counselling provided by in-clinic staff?

P: Pregnant persons having an abortion

I: Pre- and post-abortion counselling by traditional and complementary medicine professionals, pharmacists, pharmacy workers or community health workers

C: Counselling provided by in-clinic staff (i.e. generalist or specialist medical practitioners, nurses or midwives)

O:

• Effectiveness (health workers’ and clients’ correct knowledge of contraceptive options, of safe and appropriate abortion services, and of safe post-abortion care)
• Satisfaction with/acceptability of the contraception advice provided, and the counselling and services provided
• Availability of contraceptive counselling and services
• Accessibility of information and method of choice
• Privacy and confidentiality of client respected during provision of counselling and services
• Participation in provision of counselling and services
• Quality of counselling and services
• Informed decision-making after provision of counselling and services
• Accountability in the provision of counselling and services
• Mix in types of contraception offered in the counselling.

Pre-abortion

Cervical priming prior to surgical abortion

PICO 3: Cervical priming using osmotic dilators or medication (see Recommendations 19 and 20)

PICO question: For a pregnant person having an induced surgical abortion, is provision of cervical priming using osmotic dilators or medication by a traditional and complementary medicine professional, associate/advanced associate clinician, midwife, nurse or auxiliary nurse/auxiliary nurse midwife a safe, effective and satisfactory/acceptable alternative to provision of cervical priming by a physician?

P: Pregnant persons having an induced abortion with vacuum aspiration or D&E

I: Cervical priming with

• osmotic dilators provided by traditional and complementary medicine professionals, associate/advanced associated clinicians, midwives, nurses or auxiliary nurse/auxiliary nurse midwives
• medications provided by traditional and complementary medicine professionals, associate/advanced associate clinicians, midwives, nurses, auxiliary nurse/auxiliary nurse midwives, pharmacists or pharmacy workers

C: Cervical priming performed by physicians with (i) osmotic dilators or (ii) medications

O:

• Safety (serious adverse events and complications)
• Effectiveness (degree of dilatation and provider’s perception of ease of procedure)
• Satisfaction/acceptability.

Abortion

Surgical abortion at gestational ages < 14 weeks

PICO 4: Vacuum aspiration for all indications at gestational ages < 14 weeks (see Recommendation 24)

PICO question: For a pregnant person seeking induced abortion or treatment for incomplete abortion or miscarriage (i.e. all indications for vacuum aspiration), is provision of vacuum aspiration by a traditional and complementary medicine professional, auxiliary nurse midwife or auxiliary nurse a safe, effective and satisfactory/acceptable alternative to provision of vacuum aspiration by a physician?

P: Pregnant persons seeking an induced abortion or treatment for incomplete abortion or miscarriage

I: Vacuum aspiration provided by traditional and complementary medicine professional, auxiliary nurse midwives or auxiliary nurses

C: Vacuum aspiration provided by generalist or specialist medical practitioners (obstetricians/gynaecologists)

O:

• Safety (serious adverse events and complications)
• Effectiveness (success of abortion following the procedure
• Satisfaction/acceptability.

Surgical abortion at later gestational ages

PICO 5: Dilatation and evacuation (D&E) for surgical abortion at ≥ 14 weeks (see Recommendation 26)

PICO question: For a pregnant person having a surgical abortion (D&E), is provision by a traditional and complementary medicine professional, associate/advanced associate clinician, midwife a safe, effective or satisfactory/acceptable alternative to provision of care by a doctor?

P: Pregnant women seeking surgical abortion at ≥ 14 weeks of gestation

I: D&E provided by traditional and complementary medicine professionals, associate/advanced associate clinicians, midwives

C: Surgical abortion provided by generalist and specialist medical practitioners

O:

• Effectiveness (success of abortion following the procedure)
• Safety (serious adverse events and complications)
• Satisfaction/acceptability.

Medical abortion for gestational ages < 12 weeks and its component tasks (see Recommendation 28)

PICO 6: Provision of medical abortion care at < 12 weeks

PICO question: For a pregnant person seeking medical abortion at < 12 weeks, is provision of medical abortion (i.e. assessment of eligibility, administering quality assured medications, assessment of outcome/success) by a traditional and complementary medicine professional, pharmacist, pharmacy worker or community health worker, a safe, effective and satisfactory/acceptable alternative to provision of medical abortion by a physician?

P: Pregnant persons seeking medical abortion

I: Medical abortion provided by traditional and complementary medicine professionals, pharmacists, pharmacy workers or community health workers

C: Medical abortion provided by generalist or specialist medical practitioners (obstetrician/gynaecologists)

O:

• Safety (serious adverse events and complications)
• Effectiveness (success of abortion without need for surgical intervention following the treatment)
• Satisfaction/acceptability.

PICO 6a: Assessment of eligibility for MA

PICO question: For a pregnant person seeking medical abortion, is assessment of eligibility for medical abortion by a traditional and complementary medicine professional, pharmacist, pharmacy worker or community health worker a safe, effective and satisfactory/acceptable alternative to – and as accurate as – assessment by a physician?

P: Pregnant persons seeking medical abortion

I: Eligibility assessment by traditional and complementary medicine professionals, pharmacists, pharmacy workers or community health workers

C: Eligibility assessment by generalist or specialist medical practitioners (obstetrician/gynaecologists)

O:

• Effectiveness (proportion of pregnant persons deemed eligible for medical abortion by provider type and accuracy of these assessments when measured against an independent verifier and/or diagnostic standard)
• Safety (serious adverse events, excluding treatment for incomplete abortion or ongoing pregnancy)
• Effectiveness (success of abortion following the procedure)
• Satisfaction.

PICO 6b: Administration of medications for MA

PICO question: For a pregnant person seeking medical abortion, is administration of medications for medical abortion (i.e. information provision, dispensing of quality assured medications, referral to a reputable source for medications) with instructions for their use by a traditional and complementary medicine professional, pharmacist, pharmacy worker or community health worker a safe, effective and satisfactory/acceptable alternative to administration by a physician?

P: Pregnant persons seeking medical abortion

I: Administration of medications (i.e. information provision, dispensing of quality assured medications, referral to a reputable source for medications) with instructions for their use by traditional and complementary medicine professionals, pharmacists, pharmacy workers or community health workers

C: Administration of medications (i.e. information provision, dispensing of quality assured medications, referral to a reputable source for medications) by generalist or specialist medical practitioners

O:

• Participants understanding of the protocol, as shown by taking the correct regimen
• Safety (serious adverse events, excluding treatment for incomplete abortion or ongoing pregnancy)
• Effectiveness (success of abortion following the procedure)
• Satisfaction.

PICO 6c: Accurate assessment of success of the MA process

PICO question: For a pregnant person seeking medical abortion, is assessment of the success of the medical abortion process by a traditional and complementary medicine professional, pharmacist, pharmacy worker or community health worker a safe, effective and satisfactory/acceptable alternative to – and as accurate as – assessment by a physician?

P: Pregnant persons seeking medical abortion

I: Assessment of success of abortion by traditional and complementary medicine professionals, pharmacists, pharmacy workers or community health workers

C: Assessment of success of abortion by generalist or specialist medical practitioners

O:

• Effectiveness of the assessment of the outcome (proportion of pregnant persons assessed for success of abortion by provider type and accuracy of these assessments when measured against an independent verifier and/or diagnostic standard)
• Effectiveness (success of abortion following the procedure)
• Safety (serious adverse events, excluding treatment for incomplete abortion or ongoing pregnancy, ectopic pregnancy)
• Satisfaction.

Management of induced abortion at gestational ages ≥ 12 weeks

PICO 7: Provision of abortion care at ≥ 12 weeks (see Recommendation 30)

PICO question: For a pregnant person seeking induced abortion, is medical or surgical abortion by a traditional and complementary medicine professional, associate clinician, midwife, nurse, auxiliary nurse, pharmacist, pharmacy worker or community health worker a safe, effective or satisfactory alternative to provision of abortion care by doctors?

P: Pregnant women seeking medical or surgical abortion after 12 weeks of gestation

I: Medical abortion or surgical abortion provided by traditional and complementary medicine professionals, associate clinicians, midwives, nurses, auxiliary nurses, pharmacists, pharmacy workers or community health workers

C: Medical abortion or surgical abortion provided by generalist and specialist medical practitioners

O:

• Effectiveness (success of abortion without need for further medical or surgical intervention)
• Safety (serious adverse events and complications)
• Satisfaction.

Intrauterine fetal demise (IUFD)

PICO 8: Medical management of intrauterine fetal demise (IUFD) (see Recommendation 33 [NEW])

PICO question: For a pregnant person diagnosed with intrauterine fetal demise (IUFD), is medical management of IUFD (with mifepristone and misoprostol, or misoprostol alone) provided by a traditional and complementary medicine professional, associate/advanced associate clinician, midwife, nurse, auxiliary nurse/auxiliary nurse midwife, pharmacist, pharmacy worker or community health worker a safe, effective and satisfactory alternative to medical management by a physician?

P: Pregnant persons diagnosed with IUFD

I: Medical management with mifepristone and misoprostol or misoprostol alone provided by traditional and complementary medicine professionals, associate/advanced associate clinicians, midwives, nurses, auxiliary nurses/auxiliary nurse midwives, pharmacists, pharmacy workers or community health workers

C: Medical management with mifepristone and misoprostol or misoprostol alone provided by generalist or specialist medical practitioners

O:

• Safety (serious adverse events and complications)
• Effectiveness (success of abortion without need for surgical intervention following the procedure)
• Satisfaction/acceptability.

Post-abortion

Incomplete abortion at gestational ages < 14 weeks

PICO 9: Management of incomplete abortion with misoprostol (see Recommendation 37)

PICO question: For a pregnant person with incomplete abortion, is management of incomplete abortion with misoprostol provided by a traditional and complementary medicine professional, pharmacist, pharmacy worker or community health worker a safe, effective and satisfactory/acceptable alternative to management with misoprostol provided by a physician?

P: Pregnant persons with incomplete abortion

I: Medical management with misoprostol provided by traditional and complementary medicine professionals, pharmacists, pharmacy workers or community health workers

C: Medical management with misoprostol provided by generalist or specialist medical practitioners

O:

• Safety (serious adverse events and complications)
• Effectiveness (success of abortion without need for surgical intervention following the procedure)
• Satisfaction/acceptability.

PICO 10: Vacuum aspiration for management of uncomplicated incomplete abortion (see Recommendation 38)

PICO question: For a pregnant person seeking an induced abortion, is provision of vacuum aspiration for induced abortion/incomplete abortion/miscarriage (all indications) by traditional and complementary medicine professionals, auxiliary nurses or auxiliary nurse midwives a safe, effective or satisfactory option to provision of vacuum aspiration by physicians?

P: Pregnant persons seeking induced abortion

I: Vacuum aspiration provided by traditional and complementary medicine professionals, auxiliary nurses or auxiliary nurse midwives

C: Vacuum aspiration provided by generalist or specialist medical practitioners (obstetrician/gynaecologists)

O:

• Effectiveness (success of abortion following the procedure)
• Safety (serious adverse events and complications)
• Satisfaction/acceptability.

Recognizing and managing complications (see Recommendations 39 and 40)

PICO 11: Diagnosis and management of abortion-related complications

PICO question: For a person presenting with complication(s) of an induced abortion and in a stable condition, is diagnosis and management of abortion-related complications by a traditional and complementary medicine professional, pharmacist, pharmacy worker or community health worker a safe, effective and satisfactory/acceptable alternative to – and as accurate as – diagnosis and management by a physician?

P: Women presenting with complication(s) of an induced abortion and in a stable condition

I: Diagnosis and management of complications by traditional and complementary medicine professional, pharmacists, pharmacy workers or community health workers

• Diagnosis and management of infection by traditional and complementary medicine professionals, pharmacists, pharmacy workers, community health workers
• Diagnosis and management of haemorrhage by traditional and complementary medicine professionals, pharmacists, pharmacy workers, community health workers

C: Diagnosis and management of infection and heavy bleeding by generalist and specialist medical practitioners

O:

• Effectiveness (accurate determination of a complication followed by an offer of correct treatment or referral depending on professional capacity and clinical setting)
• Safety (serious adverse events)
• Satisfaction/acceptability.

Post-abortion contraception

PICO 12: Post-abortion provision of injectable contraceptives (see Recommendation 45)

PICO question: For a person in the post-abortion period needing contraception, is provision of injectable contraceptives (initiation or continuation) by a traditional and complementary medicine professional, pharmacy worker or community health worker, a safe, effective and satisfactory/acceptable alternative to provision by a trained health worker?

P: Women in the post-abortion period needing contraception

I: Delivery of injectable contraceptives, by traditional and complementary medicine professionals, pharmacy workers or community health workers

C: Delivery of injectable contraceptives by trained health workers

O:

• Contraceptive uptake and continuation
• Safety (serious adverse events and complications related to provision of the method)
• Effectiveness (method failure)
• Satisfaction/acceptability.

Service delivery considerations

Non-facility-based/outpatient/home-based care

PICO 13: Telemedicine (see Recommendation 47 [NEW])

PICO question: For a pregnant person seeking medical abortion, is medical abortion care provided through telemedicine (comprehensive care or individual components) a safe, effective and satisfactory/acceptable alternative to in-person medical abortion care?

P: Pregnant persons seeking medical abortion

I: Medical abortion care provided through telemedicine, including comprehensive medical abortion care, or any number of the following individual components:

• Eligibility assessment for medical abortion through telemedicine
• Counselling and/or instructions for medical abortion through telemedicine
• Instructions for and active facilitation of medical abortion through telemedicine
• Follow-up of medical abortion through telemedicine

C: In-person medical abortion care

O:

• Effectiveness (rates of ongoing pregnancy, success of abortion without need for surgical intervention following the procedure, and of surgical evacuation post abortion)
• Safety (serious adverse events and complications)
• Satisfaction/acceptability
• Rate of adherence to recommended dose regimen (self-reported)
• Reported cost of services.

PICO 14: Community-based outreach (see Best Practice Statement 48)

PICO question: For a pregnant person seeking induced abortion, are community-based outreach models for provision of abortion care safe, effective and satisfactory/acceptable alternatives to provision of abortion care in a health-care facility by a trained health worker?

P: Pregnant persons seeking induced abortion

I: Outreach involving health workers

C: Provision of care in a health-care facility by trained health workers

O:

• Safety (serious adverse events and complications)
• Effectiveness (success of abortion without need for surgical intervention following the procedure)
• Cost-effectiveness
• Increased health seeking behaviours
• Satisfaction/acceptability.

Setting:

• Weak infrastructure
• Legally restrictive.

PICO 15: Harm-reduction counselling (see Best Practice Statement 48)

PICO question: For a pregnant person seeking an induced abortion, is harm-reduction counselling on abortion care a safe, effective and satisfactory/acceptable alternative to routine in-clinic service delivery?

P: Pregnant persons seeking an induced abortion

I: Harm-reduction counselling

C: Routine in-clinic service delivery

O:

• Safety (serious adverse events and complications)
• Effectiveness (success of abortion without need for surgical intervention following the procedure)
• Satisfaction/acceptability.

Setting:

• Humanitarian settings
• Non-humanitarian settings.

PICO 16: Social marketing outreach/communicating safe abortion (see Best Practice Statement 48)

PICO question: For a pregnant person seeking an induced abortion, can social marketing outreach provide improved access to safe, effective and satisfactory/acceptable induced abortion services compared with provision of abortion care in a health-care facility by a trained health worker?

P: Pregnant persons seeking an induced abortion

I: Social marketing methods for induced abortion services

C: In-clinic abortion service provision

O:

• Safety (serious adverse events and complications)
• Effectiveness (success of abortion without need for surgical intervention following the procedure)
• Access (affordability, utilization, client volume, attendance and coverage per population)
• Quality of care (abortion methods of choice, quality of information given to pregnant person, provider competence, pregnant person/provider relationship)
• Adverse effects (undesirable impacts on existing public or private services, inappropriate use of services)
• Equitable access or utilization (distribution of access across sociodemographic characteristics)
• Cost/service (from a societal perspective or perspective of marketer/franchiser, franchisee or pregnant person/client)
• Satisfaction/acceptability.

PICO 17: Self-sourcing medications for induced abortion (see Best Practice Statement 48)

PICO question: For a pregnant person seeking induced abortion, is self-sourcing of medications through online sources a safe, effective and satisfactory/acceptable alternative to obtaining a prescription and/or medications from a trained health worker?

P: Pregnant persons seeking induced abortion

I: Pregnant persons self-sourcing medications for an abortion through an online source without a prescription

C: Pregnant persons obtain a prescription and/or medications from a health-care provider (specialist or generalist medical practitioner, traditional and complementary medicine professional, midwife, nurse, auxiliary nurse, auxiliary nurse midwife, pharmacist, pharmacy workers, community health worker)

O:

• Safety (serious adverse events and complications)
• Effectiveness (success of abortion without need for surgical intervention following the procedure)
• Quality of medications
• Satisfaction/acceptability.

Self-management approaches

Self-management approaches for post-abortion contraception

PICO 18: Post-abortion self-administration of injectable contraceptives (see Recommendation 50)

PICO question: For a person in the post-abortion period needing contraception, is self-administration of injectable contraceptives (initiation or continuation) a safe, effective and satisfactory/acceptable alternative to provision by a trained health worker?

P: Women in the post-abortion period needing contraception

I: Self-administration of injectable contraceptives (initiation or continuation)

C: Delivery of injectable contraceptives by trained health workers

O:

• Contraceptive uptake and continuation
• Safety (serious adverse events and complications related to provision of the method)
• Effectiveness (method failure)
• Satisfaction/acceptability.