Annexes
Annex 9: Clinical services domain PICO questions
PICO: P = population; I = intervention; C = comparator; O = outcome(s)[1]
Pre-abortion
Rhisoimmunization
PICO 1: No anti-D administration in unsensitized Rh-negative individuals seeking abortion (see Recommendation 8 [NEW])
PICO question: For an unsensitized Rh-negative individual seeking abortion at < 12 weeks of gestation, is no administration of anti-D a safe and effective alternative to routine anti-D administration?
P: Unsensitized Rh-negative individuals seeking abortion at < 12 weeks (undergoing either medical or surgical abortion)
I: No anti-D administration
C: Routine anti-D administration
O:
- Rate of isoimmunization in subsequent pregnancy
- Rate of antibody formation after initial pregnancy.
Pain management for surgical abortion
PICO 2: Pain control for surgical abortion at < 14 weeks of gestation (see Recommendations 11 and 12 [NEW])
PICO question: For a pregnant person seeking surgical abortion at < 14 weeks of gestation, is pain control with any particular method (I) safer, more effective and/or more satisfactory/acceptable compared with pain control with a different method or no pain control (C)?
P: Pregnant persons seeking surgical abortion at less than 14 weeks of gestation.
I:
- Paracervical block (PCB) [this includes the different concentrations, type (lidocaine), carbonated versus not, depth of injection]
- PCB with premedication
- Intravenous (IV) conscious sedation plus PCB
- General anaesthesia
- Topical anaesthesia (e.g. lidocaine)
- Non-pharmacological intervention (music, acupuncture, “verbicaine”, etc.)
C:
- No PCB
- PCB alone
- PCB with premedication
- IV conscious sedation plus PCB
O:
- Effectiveness (maximum pain as measured by visual analogue scale; VAS)
- Anxiety scores using VAS
- Safety (complications related to pain control methods, use of supplemental narcotic, use of any additional analgesic medication, duration of recovery time, hospital admission), side-effects
- Satisfaction/acceptability.
PICO 3: Pain control for surgical abortion at ≥ 14 weeks of gestation (see Recommendations 11, 13 and 14 [NEW])
PICO question: For a pregnant person seeking surgical abortion at ≥ 14 weeks of gestation (including cervical priming prior to the procedure), is pain control with any particular method (I) safer, more effective and/or more satisfactory/acceptable compared with pain control with a different method or no pain control (C)?
P: Pregnant persons seeking surgical abortion at 14 weeks of gestation or above
I:
- PCB [this includes the different concentrations, type (lidocaine), carbonated versus not, depth of injection]
- PCB with premedication
- IV conscious sedation plus PCB
- General anaesthesia
- Topical anaesthesia (e.g. lidocaine)
- Non-pharmacological intervention (music, acupuncture, “verbicaine”, etc.)
C:
- No PCB
- PCB alone
- PCB with premedication
- IV conscious sedation plus PCB
O:
- Effectiveness (maximum pain as measured by VAS)
- Anxiety scores using VAS
- Safety (complications related to pain-control methods, use of supplemental narcotic, use of any additional analgesic medication, duration of recovery time, hospital admission), side-effects
- Satisfaction/acceptability.
Pain management for medical abortion
PICO 4: Pain control for medical abortion at < 14 weeks of gestation (see Recommendation 15)
PICO question: For a pregnant person seeking medical abortion at < 14 weeks of gestation, is pain control with any particular (i) pharmacological method (given prophylactically or after onset of pain) or (ii) non-pharmacological method safer, more effective and/or more satisfactory/acceptable compared with any other such method or no treatment/placebo?
P: Pregnant persons seeking medical abortion at < 14 weeks of gestation
I:
- Pharmacological methods [Timing: prophylactic or after onset of pain]
- Ibuprofen
- Acetaminophen plus codeine
- Anti-emetics
- Loperamide
- Tramadol
- Non-pharmacological methods (music, acupuncture, “verbicaine”, etc.)
C:
- Pharmacological methods [Timing: prophylactic or after onset of pain]
- Ibuprofen
- Acetaminophen plus codeine
- Anti-emetics
- Loperamide
- Tramadol
- Non-pharmacological methods (music, acupuncture, “verbicaine”, etc.)
- No treatment/placebo
O:
- Effectiveness (maximum pain as measured by VAS)
- Safety (complications related to pain-control methods, use of any supplemental narcotic, use of any additional analgesic medication), side-effects
- Effectiveness of medical abortion regimen, defined as successful completion without additional surgical intervention
- Time to expulsion
- Satisfaction/acceptability.
PICO 5: Pain control for medical abortion at ≥ 14 weeks of gestation (see Recommendation 16 [NEW])
PICO question: For a pregnant person seeking medical abortion at ≥ 14 weeks of gestation, is pain control with any particular (i) pharmacological method (given prophylactically or after onset of pain) or (ii) non-pharmacological method safer, more effective and/or more satisfactory/acceptable compared with any other such methods or no treatment/placebo?
P: Pregnant persons seeking medical abortion at 14 weeks of gestation or above
I:
- Pharmacological methods [Timing: prophylactic or after onset of pain]
- Pretreatment (ibuprofen, acetaminophen plus codeine, antiemetics, loperamide, tramadol)
- IV opiates
- PCB
- Non-pharmacological methods (music, acupuncture, “verbicaine”, etc.)
C:
- Pharmacological methods [Timing: prophylactic or after onset of pain]
- Pretreatment (ibuprofen, acetaminophen plus codeine, antiemetics, loperamide, tramadol)
- IV opiates
- PCB
- Non-pharmacological methods (music, acupuncture, “verbicaine”, etc.)
- No treatment/placebo
O:
- Effectiveness (maximum pain as measured by VAS)
- Safety (complications, use of any supplemental narcotic, use of any additional analgesic medication), side-effects
- Effectiveness of medical abortion regimen, defined as successful completion without additional surgical intervention
- Time to expulsion
- Satisfaction/acceptability.
Cervical priming
PICO 6a: Cervical priming at < 12 weeks of gestation (see Recommendation 17)
PICO question: For a pregnant person seeking surgical abortion at < 12 weeks of gestation, is cervical priming effective, safe and acceptable?
P: Pregnant persons seeking surgical abortion < 12 weeks
I: Cervical priming with medication or mechanical methods
C: Cervical priming with placebo, with medication (using different routes, doses or treatment intervals) or with different mechanical methods
O:
- Effectiveness
- Satisfaction/acceptability
- Safety.
PICO 6b: Cervical priming at ≥ 12 weeks with medications (comparing different regimens) (see Recommendations 18b–d [NEW])
PICO question: For a pregnant person seeking surgical abortion at ≥ 12 weeks of gestation, is cervical priming with mifepristone plus misoprostol or with mifepristone alone a safe, effective and satisfactory/acceptable alternative to cervical preparation with misoprostol alone?
P: Pregnant persons seeking surgical abortion at ≥ 12 weeks
I: Cervical priming with
- Mifepristone plus misoprostol [various routes, doses, intervals]
- Mifepristone alone [various routes, doses, intervals]
C: Cervical priming with misoprostol alone [various routes, doses, intervals]
O:
- Effectiveness (pre-procedure cervical dilatation, need for further dilatation, ease of procedure, time to complete procedure)
- Safety (complications, need for additional interventions, pre- and post-procedure pain), side-effects
- Satisfaction (client and provider)/acceptability
- Cost (comparative cost and cost to the client).
PICO 7: Cervical priming at ≥ 12 weeks with medications compared with mechanical methods (see Recommendation 18b [NEW])
PICO question: For a pregnant person seeking surgical abortion at ≥ 12 weeks of gestation, is cervical priming with medical methods (mifepristone, misoprostol, or both) a safe, effective and satisfactory/acceptable alternative to mechanical methods (laminaria, foley bulb, dilapan)?
P: Pregnant persons seeking surgical abortion at ≥ 12 weeks
I: Cervical priming with medical methods
- Mifepristone alone
- Misoprostol plus mifepristone
- Misoprostol alone
C: Cervical priming with mechanical methods (i.e. laminaria, foley bulb, dilapan)
O:
- Effectiveness (pre-procedure cervical dilatation, need for further dilatation, ease of procedure, time to complete procedure)
- Safety (complications, need for additional interventions, pre- and post-procedure pain), side-effects
- Satisfaction (client and provider)/acceptability
- Cost (comparative cost and cost to the client).
PICO 8: Cervical priming at ≥ 12 weeks with medication(s) plus laminaria compared with laminaria alone (see Recommendation 18d [NEW])
PICO question: For a pregnant person seeking surgical abortion at ≥ 12 weeks of gestation, is cervical priming with medication(s) plus laminaria a safe, effective and satisfactory/acceptable alternative to cervical preparation with laminaria alone?
P: Pregnant persons seeking surgical abortion at ≥ 12 weeks
I: Cervical priming with medication(s) plus laminaria
- Mifepristone plus misoprostol plus laminaria
- Misoprostol plus laminaria
- Mifepristone plus laminaria
C: Cervical priming with laminaria alone
O:
- Effectiveness (pre-procedure cervical dilatation, need for further dilatation, ease of procedure, time to complete procedure)
- Safety (complications, need for additional interventions, pre- and post-procedure pain), side-effects
- Satisfaction (client and provider)/acceptability
- Cost (comparative cost and cost to the client).
PICO 9: Cervical priming at ≥ 12 weeks by mechanical method(s) before dilatation and evacuation (D&E) (see Recommendation 18 [NEW])
PICO question: For a pregnant person seeking surgical abortion (D&E) at ≥ 12 weeks of gestation, is cervical priming with one mechanical method a safe, effective and satisfactory/acceptable alternative to cervical priming with a different mechanical method?
P: Pregnant person seeking surgical abortion at ≥ 12 weeks
I: Cervical priming with one mechanical method before D&E
C: Cervical priming with a different mechanical method before D&E
O:
- Effectiveness (pre-procedure cervical dilatation, need for further dilatation, ease of procedure, time to complete procedure)
- Safety (complications, need for additional interventions, pre- and post-procedure pain), side-effects
- Satisfaction (client and provider)/acceptability
- Cost (comparative cost and cost to the client).
Abortion
New medical methods for abortion
PICO 10: Medical abortion with letrozole plus misoprostol, compared with misoprostol alone (see Recommendation 27c [NEW])
PICO question: For a pregnant person seeking medical abortion, is medical abortion with letrozole plus misoprostol a safe, effective and satisfactory/acceptable alternative to medical abortion with misoprostol alone?
P: Pregnant persons seeking medical abortion (all gestational ages)
I: Medical abortion with letrozole plus misoprostol [various routes, doses, intervals]
C: Medical abortion with misoprostol alone [various routes, doses, intervals]
O:
- Effectiveness (ongoing pregnancy rate, procedure completed without surgical intervention)
- Safety (serious adverse events and complications), side-effects
- Expulsion time from initiation of treatment
- Satisfaction/acceptability
- Cost (comparative and cost to the client).
PICO 11: Medical abortion with letrozole plus misoprostol, compared with mifepristone plus misoprostol
PICO question: For a pregnant person seeking medical abortion, is medical abortion with letrozole plus misoprostol a safe, effective and satisfactory alternative to medical abortion with mifepristone plus misoprostol?
P: Pregnant persons seeking medical abortion (all gestational ages)
I: Medical abortion with letrozole plus misoprostol [various routes, doses, intervals]
C: Medical abortion with mifepristone plus misoprostol [various routes, doses, intervals]
O:
- Effectiveness (ongoing pregnancy rate, completed without surgical intervention)
- Safety (serious adverse events and complications), side-effects
- Expulsion time from initiation of treatment
- Satisfaction/acceptability
- Cost (comparative and cost to the client).
PICO 12: Medical abortion with mifepristone plus letrozole, compared with misoprostol alone
PICO question: For a pregnant person seeking medical abortion, is medical abortion with mifepristone plus letrozole a safe, effective and satisfactory alternative to medical abortion with misoprostol alone?
P: Pregnant person seeking medical abortion
I: Medical abortion with mifepristone plus letrozole [various routes, doses, intervals]
C: Medical abortion with misoprostol alone [various routes, doses, intervals]
O:
- Effectiveness (ongoing pregnancy rate, completed without surgical intervention)
- Safety (serious adverse events and complications), side-effects
- Expulsion time from initiation of treatment
- Satisfaction/acceptability
- Cost (comparative and cost to the client).
Missed abortion at < 14 weeks of gestation
PICO 13: Medical management of missed abortion with mifepristone plus misoprostol (see Recommendation 31 [NEW])
PICO question: For a pregnant person with missed abortion at < 14 weeks of gestation, is medical management with mifepristone plus misoprostol a safe, effective and satisfactory/acceptable alternative to medical management with misoprostol alone?
P: Pregnant persons with missed abortion < 14 weeks
I: Medical management with mifepristone plus misoprostol [various routes, doses, intervals]
C: Medical management with misoprostol alone [routes, doses, intervals]
O:
- Effectiveness (failed expulsion/ongoing retained products, completed without surgical intervention)
- Safety (serious adverse events and complications), side-effects
- Expulsion time from initiation of treatment
- Satisfaction/acceptability
- Cost of treatment.
PICO 14: Medical management of missed abortion with all regimens (see Recommendation 31 [NEW])
PICO question: For a pregnant person with missed abortion at < 14 weeks of gestation, is medical management (all regimens) a safe, effective and satisfactory/acceptable alternative to expectant management?
P: Pregnant persons with missed abortion < 14 weeks
I: Medical management (all regimens)
C: Expectant management
O:
- Effectiveness (failed expulsion/ongoing retained products, completed without surgical intervention)
- Safety (serious adverse events and complications), side-effects
- Expulsion time from initiation of treatment
- Satisfaction/acceptability
- Cost of treatment.
PICO 15: Surgical management of missed abortion (see Recommendation 31 [NEW])
PICO question: For a pregnant person with missed abortion at < 14 weeks of gestation, is surgical management a safe, effective and satisfactory/acceptable alternative to medical or expectant management?
P: Pregnant persons with missed abortion < 14 weeks
I: Surgical management
C:
- Medical management
- Expectant management
O:
- Effectiveness (failed expulsion/ongoing retained products, completed without surgical intervention
- Safety (serious adverse events and complications), side-effects
- Expulsion time from initiation of treatment
- Satisfaction/acceptability
- Cost of treatment.
Self-management approaches
Self-management of medical abortion (see Recommendation 49)
PICO 16: Self-management of medical abortion
PICO question: For a pregnant person seeking medical abortion, is self-management of the process of medical abortion (assessing eligibility, administration of mifepristone and/or misoprostol, self-assessing outcome/success), without direct supervision of a trained health worker, a safe, effective and satisfactory/acceptable alternative to medical abortion managed by a trained health worker?
P: Pregnant persons seeking medical abortion at any gestational age
I: Pregnant persons self-managing the process of medical abortion (in whole) without direct supervision of a trained health worker
C: Medical abortion managed by a trained health worker (all medication abortion regimens)
O:
- Effectiveness (success of abortion without need for surgical intervention following the procedure)
- Safety (serious adverse events and complications)
- Satisfaction/acceptability
- Physical and emotional experience (side-effects, positive and negative emotions, internalized stigma), knowing when to seek medical care (unscheduled visits, phone calls to the clinic, emergency visits)
- Cost.
PICO 16a: Self-assessment of eligibility for MA
PICO question: For a pregnant person seeking medical abortion, is self-assessment of eligibility[2] for medical abortion a safe, effective and satisfactory/acceptable alternative to eligibility assessment by a physician or other trained health-care provider?
P: Pregnant persons seeking medical abortion at any gestational age
I: Pregnant persons self-managing the first part of the medical abortion process by self-assessing their eligibility for medical abortion without direct supervision of a health-care provider
C: Eligibility assessment performed by a trained health-care provider
O:
- Proportion of pregnant persons deemed eligible for medical abortion
- Proportion of pregnant persons who were deemed ineligible due to gestational age
- Proportion of pregnant persons who were deemed ineligible due to contraindications
- Accuracy of these assessments when measured against an independent verifier and/or diagnostic standard
- Ongoing pregnancy
- Completed without surgical intervention
- Safety (serious adverse events and complications)
PICO 16b: Self-administering medications for medical abortion
PICO question: For a person seeking medical abortion, is self-administration of medications for medical abortion, when provided with instructions for their use from a reliable source, a safe, effective and satisfactory/acceptable alternative to administration of medications by a trained health worker?
P: Pregnant persons seeking medical abortion at any gestational ages
I: Pregnant persons self-administering the medications for medical abortion (as part of the medical abortion process) without direct supervision by a health-care provider (but with instructions from a reliable source of health care)
C: Administration of medications for medical abortion by a trained health worker
O:
- Pregnant persons’ adherence to the recommended medical abortion regimen following instructions
- Effectiveness (ongoing pregnancy rate, completed without surgical intervention)
- Safety (serious adverse events and complications), side-effects
- Expulsion time from initiation of treatment
- Physical and emotional experience (side-effects, positive and negative emotions, internalized stigma), knowing when to seek medical care (unscheduled visits, phone calls to the clinics, emergency visits)
- Satisfaction/acceptability
- Cost (comparative and cost to the client).
PICO 16c: Self-assessment of the outcome of the medical abortion process
PICO question: For an individual who has undergone medical abortion, is self-assessment of the outcome/success of medical abortion a safe, effective and satisfactory/acceptable alternative to assessment of the outcome/success by a trained health worker?
P: Individuals who have undergone medical abortion
I: Pregnant persons self-managing the last part of the medical abortion process by self-assessing the outcome/success of the abortion without direct supervision by a trained health worker
C: Assessment of outcome/success of abortion by a trained health worker
O:
- Effectiveness (proportion of pregnant persons assessed to have successful abortion, accuracy of these assessments when measured against an independent verifier and/or diagnostic standard)
- Ongoing pregnancy rate
- Completed without surgical intervention
- Safety (serious adverse events and complications), side-effects
- Expulsion time from initiation of treatment;
- Physical and emotional experience (side-effects, positive and negative emotions, internalized stigma), knowing when to seek medical care (unscheduled visits; phone calls to the clinics, emergency visits)
- Satisfaction/acceptability
- Cost (comparative and cost to the client).
Footnotes
- For further information on the findings of the reviews based on the PICOs presented in this annex, refer to the EtD frameworks in Supplementary material 2. ↩
- Eligibility criteria defined as: < 12 weeks; no contraindications; no signs or symptoms of ectopic pregnancy. ↩