Misoprostol distribution

GRADE-CERQual Assessment Worksheet

Evidence Profile

GRADE-CERQual
Summarized Methodological
# Coherence Adequacy Relevance assessment of References
Review Finding limitations
confidence
1 Licencing was absent Moderate concerns Minor concerns No/Very minor No/Very minor High confidence Moore JE et al. 2016;
Osur J et al. 2013;
as most countries or concerns concerns Sheldon WR et al. 2014;
ministries did not two studies with All studies explore four studies with Starrs A & Winikoff B 2012;
have misoprostol moderate concerns; policy environment Data is adequately Studies reflect moderate concerns
registered or No reflexivity, in the countries; One rich; Data is from context from multiple regarding
lincenced for the limited reflection on study highlights over 70 countries, countries, including methodological
management of PAC interviewer bias; licencing of and hence covers Affrica, Asia and limitations and
or PPH. Our focus Another only misoprostol for other multiple contexts to represnt both urban Minor concerns
was on prevention of evaluated a limited purposes, which is inform the finding. and rural populations regarding coherence
PPH. There was also category of service not explicitly with only one study.
limited providers mentioned in review No/Very minor
understanding of finding. Review's concerns regarding
existing policy. comment on adequacy, and
inconsistence in use relevance
of other guidelines
does not explicity
mention specific
guidelines

Characteristics of Studies
Author(s), Year
Moore JE et al. 2016
Question/objective
The aim of the current study
was to conduct a qualitative
process evaluation of progress,
barriers, facilitators, and
proposed solutions to
operationalize nine
study setting
Country: Kosovo
Rural/Urban: both Health
facility/ community based:
Policy level Public/Private
facility: both
methods of data collection
study participants Key findings from study
and study design
Local stakeholders (policy Realistic Evaluation approach, 1. Lack of guidelines and
makers, researchers, academia, using qualitative approach; protocols, 2. There is lack
frontline health care providers, FGD’s, IDI’s. of awareness and clarity
representative from regarding difference between
professional associations and protocol and guidelines. 3. Lack
NGO’s representatives) of decision making power

Author(s), Year Question/objective
recommendations to prepare
Kosovo to implement the 2012
World Health Organization
(WHO) prevention and
treatment of postpartum
haemorrhage guideline
Osur J et al. 2013 a. To evaluate the
effectiveness of the process
used in introducing MPAC in Public/Private facility: both
the health system; b. To
approximate the minimum
capacity (infrastructure,
equipment, supplies, and
human resources) required in
health facilities to provide
MPAC; c. To assess
patient satisfaction with MPAC
from the perspectives of the
care providers;
Sheldon WR et al. 2014 To find out about countries’
national guidelines for PPH,
and inclusion of key PPH
medicines on national EMLs as Public/Private facility: n/a
well as any challenges to
implementing evidence-based
practice in order to further
support national FIGO Member
Associations in their work
towards their maternal health
goals
Starrs A & Winikoff B 2012 To assess and address coverage Country: developing countries
gaps in using misoprostol
study setting
Country: Kenya and
Uganda Rural/Urban: Urban
Country: developing countries
(69 FIGO Countries)
Rural/Urban: both
Rural/Urban: both
Facility/community based:
community based
Public/Private facility: n/a
methods of data collection
study participants Key findings from study
and study design
among stake-holders to reach a
final decision. 4. Lack of
motivation among providers
due to lack of clarity and no
monetary incentives. 5. lack
of communication between key
stakeholder groups 6. a
focus on punitive interventions
(rather than taking a more
positive, motivational
approach)
Service providers, Health Qualitative, utilizing In depth 1. Lack of national
Facility Managers, MoH interviews policies and guidelines for
officials, NGO staff involved in MPAC. 2. Registration
program implementation of misoprostol specifically for
PAC 3. Procuring misoprostol
and maintain adequate supplies.
4. Inadequate staffing of
facilities with providers trained
in MPAC ative study
members of International web based survey was 1. Healthcare providers
Federation of Gynecology and developed and sent out by don’t know about guidelines. 2.
Obstetrics assiociation email to 130 FIGO Member Misoprostol not
Associations included in National EML. 3.
No guideline for
misoprostol specific for PPH.
4. No registration of
misoprostol specific for PPH
Not mentioned Special communication 1. Association with
abortion endanger discomfort
and resistance among policy
makers and providers. 2. No
registration of misoprostol for
other than management of
 methods of data collection
Author(s), Year Question/objective study setting study participants Key findings from study
and study design
gastric ulcer. 3. Lack of clear
and consistent usage guidance
often outdated, non-evidence
based protocol in practice. 4.
Fear of its promotion,
it may deter women from
seeking care at facilities with
skilled providers. 5. It is
perceived that if misoprostol is
widely available, it will be
repurposed for used in medical
abortion, thus increasing
number of abortions.

Methodological Assessments
Justification
Was the aim of Response rate Statistical Reliability and Other
sample Data adequately Discussion of Null findings
Author(s), Year the study and drop out significance validity measures methodological
representative of described generalizability interpreted
explicity stated? specified assessed justified limitations
population
Moore JE et al. Yes no Yes Yes no Yes Yes no
2016
Osur J et al. Yes Yes Yes Yes No Yes No No
2013
Sheldon WR et yes no Yes Yes no Yes Yes Yes
al. 2014
Starrs A & Yes no Yes Yes no Yes Yes no
Winikoff B 2012

Extracted Data
Author(s), Year Extracted data supporting the review finding
Osur J et al. 2013; Gaps identified 1.Lack of national policies and guidelines for MPAC. 2. Registration of
misoprostol specifically for PAC 3. Procuring misoprostol and maintain adequate supplies. 4.
Inadequate staffing of facilities with providers trained in MPAC advantages
mentioned; 1. Acceptability of women to MPAC 2. Task shifting of MPAC
provision to midlevel providers in a rational manner 3. Offer women greater privacy,
reduced cost, option for non-invasive treatment for incomplete abortion. Limitations of study;
1. Single interviewer conducting interview country wide 2. Baseline service
delivery data prior to implementation and client’s satisfaction data from women receiving
MPAC services were not gathered.
Sheldon WR et al. 2014; Gaps identified; 1. Healthcare providers don’t know about guidelines. 2. Misoprostol
Author(s), Year
Starrs A & Winikoff B 2012;
Moore JE et al. 2016;
Extracted data supporting the review finding
not included in National EML. 3. No guideline for misoprostol specific for PPH. 4. No
registration of misoprostol specific for PPH Advantages; 1. Safe and clinically effective if
administered appropriately. 2. Cost-effective intervention Limitations; This survey was
limited in that it did not ask about which healthcare providers were able to give key medicines,
and was directed at the guidelines for obstetricians and gynecologists rather than other
healthcare providers
Barriers identified; 1. Association with abortion endanger discomfort and resistance among
policy makers and providers. 2. No registration of misoprostol for other than management
of gastric ulcer. 3. Lack of clear and consistent usage guidance often outdated, non-
evidence based protocol in practice. 4. Fear of its promotion, it may deter women from
seeking care at facilities with skilled providers. 5. It is perceived that if misoprostol is
widely available, it will be repurposed for used in medical abortion, thus increasing number of
abortions. Advantages mentioned; 3. Safe and clinically effective if administered
appropriately. 4. Cost-effective intervention No limitations are given;
Key findings 1. Lack of guidelines and protocols, 2. There is lack of awareness and
clarity regarding difference between protocol and guidelines. 3. Lack of decision
making power among stake-holders to reach a final decision. 4. Lack of motivation
among providers due to lack of clarity and no monetary incentives. 5. lack of communication
between key stakeholder groups Limitations of this study 1. Time-limited grants, little
research is done to evaluate the long-term activities and impacts of implementation efforts. 2.
Communication challenges between groups were identified as a major barrier in 2012
and continue to pose challenges. 3. Finally, our understanding and interpretation of the data
were limited by cultural barriers and local contextual factors