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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Facilitators and barriers to the effective implementation of the individual maternal near-miss case reviews in low/middle-income countries: a systematic review of qualitative studies</title><author><name sortKey="Lazzerini, Marzia" sort="Lazzerini, Marzia" uniqKey="Lazzerini M" first="Marzia" last="Lazzerini">Marzia Lazzerini</name><affiliation><nlm:aff id="aff1"><institution content-type="department">WHO Collaborating Centre for Maternal and Child Health</institution>,<institution>Institute for Maternal and Child Health IRCCS Burlo Garofolo</institution>,<addr-line content-type="city">Trieste</addr-line>,<country>Italy</country></nlm:aff></affiliation></author><author><name sortKey="Ciuch, Margherita" sort="Ciuch, Margherita" uniqKey="Ciuch M" first="Margherita" last="Ciuch">Margherita Ciuch</name><affiliation><nlm:aff id="aff1"><institution content-type="department">WHO Collaborating Centre for Maternal and Child Health</institution>,<institution>Institute for Maternal and Child Health IRCCS Burlo Garofolo</institution>,<addr-line content-type="city">Trieste</addr-line>,<country>Italy</country></nlm:aff></affiliation></author><author><name sortKey="Rusconi, Silvia" sort="Rusconi, Silvia" uniqKey="Rusconi S" first="Silvia" last="Rusconi">Silvia Rusconi</name><affiliation><nlm:aff id="aff2"><institution content-type="department">Department of Obstetrics and Gynecology</institution>,<institution>Hospital of Padova</institution>,<addr-line content-type="city">Padova</addr-line>,<country>Italy</country></nlm:aff></affiliation></author><author><name sortKey="Covi, Benedetta" sort="Covi, Benedetta" uniqKey="Covi B" first="Benedetta" last="Covi">Benedetta Covi</name><affiliation><nlm:aff id="aff1"><institution content-type="department">WHO Collaborating Centre for Maternal and Child Health</institution>,<institution>Institute for Maternal and Child Health IRCCS Burlo Garofolo</institution>,<addr-line content-type="city">Trieste</addr-line>,<country>Italy</country></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">29961025</idno><idno type="pmc">6042547</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6042547</idno><idno type="RBID">PMC:6042547</idno><idno type="doi">10.1136/bmjopen-2017-021281</idno><date when="2018">2018</date><idno type="wicri:Area/Pmc/Corpus">000319</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000319</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Facilitators and barriers to the effective implementation of the individual maternal near-miss case reviews in low/middle-income countries: a systematic review of qualitative studies</title><author><name sortKey="Lazzerini, Marzia" sort="Lazzerini, Marzia" uniqKey="Lazzerini M" first="Marzia" last="Lazzerini">Marzia Lazzerini</name><affiliation><nlm:aff id="aff1"><institution content-type="department">WHO Collaborating Centre for Maternal and Child Health</institution>,<institution>Institute for Maternal and Child Health IRCCS Burlo Garofolo</institution>,<addr-line content-type="city">Trieste</addr-line>,<country>Italy</country></nlm:aff></affiliation></author><author><name sortKey="Ciuch, Margherita" sort="Ciuch, Margherita" uniqKey="Ciuch M" first="Margherita" last="Ciuch">Margherita Ciuch</name><affiliation><nlm:aff id="aff1"><institution content-type="department">WHO Collaborating Centre for Maternal and Child Health</institution>,<institution>Institute for Maternal and Child Health IRCCS Burlo Garofolo</institution>,<addr-line content-type="city">Trieste</addr-line>,<country>Italy</country></nlm:aff></affiliation></author><author><name sortKey="Rusconi, Silvia" sort="Rusconi, Silvia" uniqKey="Rusconi S" first="Silvia" last="Rusconi">Silvia Rusconi</name><affiliation><nlm:aff id="aff2"><institution content-type="department">Department of Obstetrics and Gynecology</institution>,<institution>Hospital of Padova</institution>,<addr-line content-type="city">Padova</addr-line>,<country>Italy</country></nlm:aff></affiliation></author><author><name sortKey="Covi, Benedetta" sort="Covi, Benedetta" uniqKey="Covi B" first="Benedetta" last="Covi">Benedetta Covi</name><affiliation><nlm:aff id="aff1"><institution content-type="department">WHO Collaborating Centre for Maternal and Child Health</institution>,<institution>Institute for Maternal and Child Health IRCCS Burlo Garofolo</institution>,<addr-line content-type="city">Trieste</addr-line>,<country>Italy</country></nlm:aff></affiliation></author></analytic><series><title level="j">BMJ Open</title><idno type="eISSN">2044-6055</idno><imprint><date when="2018">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>The maternal near-miss cases review (NMCR), a type of clinical audit, proved to be effective in improving quality of care and decreasing maternal mortality in low/middle-income countries (LMICs). However, challenges in its implementation have been described.</p></sec><sec><title>Objectives</title><p>Synthesising the evidence on facilitators and barriers to the effective implementation of NMCR in LMICs.</p></sec><sec><title>Design</title><p>Systematic review of qualitative studies.</p></sec><sec><title>Data sources</title><p>MEDLINE, LILACS, Global Health Library, SCI-EXPANDED, SSCI, Cochrane library and Embase were searched in December 2017.</p></sec><sec><title>Eligibility criteria for selecting studies</title><p>Qualitative studies exploring facilitators and/or barriers of implementing NMCR in LMIC were included.</p></sec><sec><title>Data extraction and synthesis</title><p>Two independent reviewers extracted data, performed thematic analysis and assessed risk of bias.</p></sec><sec><title>Results</title><p>Out of 25 361 papers retrieved, 9 studies from Benin, Brazil, Burkina Faso, Cote D’Ivoire, Ghana, Malawi, Morocco, Tanzania, Uganda could be included in the review. The most frequently reported barriers to NMCR implementation were the following: absence of national guidelines and local protocols; insufficient training on how to perform the audit; lack of leadership, coordination, monitoring and supervision; lack of resources and work overload; fear of blame and punishment; poor knowledge of evidenced-based medicine; hierarchical differences among staff and poor understating of the benefits of the NMCR. Major facilitators to NMCR implementation included: good leadership and coordination; training of all key staff; a good cultural environment; clear staff’s perception on the benefits of conducting audit; patient empowerment and the availability of external support.</p></sec><sec><title>Conclusions</title><p>In planning the NMCR implementation in LMICs, policy-makers should consider actions to prevent and mitigate common challenges to successful NMCR implementation. Future studies should aim at documenting facilitators and barriers to NMCR outside the African Region.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Tuncalp, " uniqKey="Tuncalp ">Ӧ Tunçalp</name></author><author><name sortKey="Were, Wm" uniqKey="Were W">WM Were</name></author><author><name sortKey="Maclennan, C" uniqKey="Maclennan C">C MacLennan</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Tuncalp, O" uniqKey="Tuncalp O">O Tunçalp</name></author><author><name sortKey="Hindin, Mj" uniqKey="Hindin M">MJ Hindin</name></author><author><name sortKey="Souza, Jp" uniqKey="Souza J">JP Souza</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lazzerini, M" uniqKey="Lazzerini M">M Lazzerini</name></author><author><name sortKey="Richardson, S" uniqKey="Richardson 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<front><journal-meta><journal-id journal-id-type="nlm-ta">BMJ Open</journal-id><journal-id journal-id-type="iso-abbrev">BMJ Open</journal-id><journal-id journal-id-type="hwp">bmjopen</journal-id><journal-id journal-id-type="publisher-id">bmjopen</journal-id><journal-title-group><journal-title>BMJ Open</journal-title></journal-title-group><issn pub-type="epub">2044-6055</issn><publisher><publisher-name>BMJ Publishing Group</publisher-name><publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">29961025</article-id><article-id pub-id-type="pmc">6042547</article-id><article-id pub-id-type="publisher-id">bmjopen-2017-021281</article-id><article-id pub-id-type="doi">10.1136/bmjopen-2017-021281</article-id><article-categories><subj-group subj-group-type="heading"><subject>Global Health</subject><subj-group><subject>Research</subject></subj-group></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>1506</subject><subject>1699</subject></subj-group></article-categories><title-group><article-title>Facilitators and barriers to the effective implementation of the individual maternal near-miss case reviews in low/middle-income countries: a systematic review of qualitative studies</article-title></title-group><contrib-group><contrib id="author-50788063" contrib-type="author"><name><surname>Lazzerini</surname><given-names>Marzia</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib id="author-59762745" contrib-type="author"><name><surname>Ciuch</surname><given-names>Margherita</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib id="author-59762782" contrib-type="author"><name><surname>Rusconi</surname><given-names>Silvia</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib id="author-59762799" contrib-type="author"><name><surname>Covi</surname><given-names>Benedetta</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib></contrib-group><aff id="aff1"><label>1</label><institution content-type="department">WHO Collaborating Centre for Maternal and Child Health</institution>,<institution>Institute for Maternal and Child Health IRCCS Burlo Garofolo</institution>,<addr-line content-type="city">Trieste</addr-line>,<country>Italy</country></aff><aff id="aff2"><label>2</label><institution content-type="department">Department of Obstetrics and Gynecology</institution>,<institution>Hospital of Padova</institution>,<addr-line content-type="city">Padova</addr-line>,<country>Italy</country></aff><author-notes><corresp><label>Correspondence to</label> Dr Marzia Lazzerini; <email>marzia.lazzerini@burlo.trieste.it</email></corresp></author-notes><pub-date pub-type="collection"><year>2018</year></pub-date><pub-date pub-type="epub"><day>30</day><month>6</month><year>2018</year></pub-date><volume>8</volume><issue>6</issue><elocation-id>e021281</elocation-id><history><date date-type="received"><day>21</day><month>12</month><year>2017</year></date><date date-type="rev-recd"><day>19</day><month>4</month><year>2018</year></date><date date-type="accepted"><day>20</day><month>4</month><year>2018</year></date></history><permissions><copyright-statement>© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.</copyright-statement><copyright-year>2018</copyright-year><license license-type="open-access"><license-p>This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/">http://creativecommons.org/licenses/by-nc/4.0/</ext-link></license-p></license></permissions><self-uri xlink:title="pdf" xlink:href="bmjopen-2017-021281.pdf"></self-uri><self-uri content-type="reviewers-comments-pdf" xlink:href="bmjopen-2017-021281.reviewer_comments.pdf"></self-uri><self-uri content-type="draft-revisions-pdf" xlink:href="bmjopen-2017-021281.draft_revisions.pdf"></self-uri><abstract><sec><title>Background</title><p>The maternal near-miss cases review (NMCR), a type of clinical audit, proved to be effective in improving quality of care and decreasing maternal mortality in low/middle-income countries (LMICs). However, challenges in its implementation have been described.</p></sec><sec><title>Objectives</title><p>Synthesising the evidence on facilitators and barriers to the effective implementation of NMCR in LMICs.</p></sec><sec><title>Design</title><p>Systematic review of qualitative studies.</p></sec><sec><title>Data sources</title><p>MEDLINE, LILACS, Global Health Library, SCI-EXPANDED, SSCI, Cochrane library and Embase were searched in December 2017.</p></sec><sec><title>Eligibility criteria for selecting studies</title><p>Qualitative studies exploring facilitators and/or barriers of implementing NMCR in LMIC were included.</p></sec><sec><title>Data extraction and synthesis</title><p>Two independent reviewers extracted data, performed thematic analysis and assessed risk of bias.</p></sec><sec><title>Results</title><p>Out of 25 361 papers retrieved, 9 studies from Benin, Brazil, Burkina Faso, Cote D’Ivoire, Ghana, Malawi, Morocco, Tanzania, Uganda could be included in the review. The most frequently reported barriers to NMCR implementation were the following: absence of national guidelines and local protocols; insufficient training on how to perform the audit; lack of leadership, coordination, monitoring and supervision; lack of resources and work overload; fear of blame and punishment; poor knowledge of evidenced-based medicine; hierarchical differences among staff and poor understating of the benefits of the NMCR. Major facilitators to NMCR implementation included: good leadership and coordination; training of all key staff; a good cultural environment; clear staff’s perception on the benefits of conducting audit; patient empowerment and the availability of external support.</p></sec><sec><title>Conclusions</title><p>In planning the NMCR implementation in LMICs, policy-makers should consider actions to prevent and mitigate common challenges to successful NMCR implementation. Future studies should aim at documenting facilitators and barriers to NMCR outside the African Region.</p></sec></abstract><kwd-group><kwd>near miss case review</kwd><kwd>facilitators and barriers</kwd><kwd>systematic review</kwd><kwd>low and middle income countries</kwd></kwd-group><funding-group><award-group id="funding-1"><funding-source><institution-wrap><institution>GREAT Network, Canadian Institutes of Health Research, St. Michael’s Hospital, Toronto.</institution></institution-wrap></funding-source></award-group></funding-group><custom-meta-group><custom-meta><meta-name>special-feature</meta-name><meta-value>unlocked</meta-value></custom-meta></custom-meta-group></article-meta></front><body><boxed-text id="BX1" position="float" orientation="portrait"><caption><title>Strengths and limitations of this study</title></caption><list list-type="bullet"><list-item><p>This review fills a gap in evidence synthesis by systematically reporting scientific literature on facilitators and barriers to effective implementation of near-miss cases review (NMCR) in low/middle-income countries (LMICs).</p></list-item><list-item><p>Findings of this review are limited by the paucity of existing scientific reports: although the NMCR approach has been used in many countries (such as in Europe, Central Asia, South East Asia, Latin America and the Caribbean), there has been relatively few formal studies exploring facilitators and barriers to effective NMCR implementation.</p></list-item><list-item><p>Despite the above-described limitation, this review retrieved an appreciable number of good-quality studies from the African Region and provides a list of recommendations relevant for both researchers and policy-makers for facilitating effective NMCR implementation in LMICs.</p></list-item></list></boxed-text><sec id="s1"><title>Background</title><p>Ensuring adequate quality of healthcare is a primary objective of the WHO Global Strategy for Women’s, Children’s and Adolescent’s Health 2016–2030.<xref rid="R1" ref-type="bibr">1</xref> Quality in healthcare is recognised as essential for the health and well-being of the population and as a basic aspect of human rights.<xref rid="R2" ref-type="bibr">2 3</xref></p><p>Among different approaches aiming at improving quality of care in maternity services, the maternal near-miss cases review (NMCR) approach was promoted by WHO and partners since 2004 within the strategy Beyond the Numbers.<xref rid="R4" ref-type="bibr">4</xref> A maternal near-miss case is defined as a woman who nearly died but survived a complication that occurred during pregnancy, childbirth or within 6 weeks after pregnancy.<xref rid="R5" ref-type="bibr">5</xref> The facility-based individual NMCR cycle is defined as a type of criterion-based audit seeking to improve maternal and perinatal healthcare and outcomes by conducting a review, at hospital level, of the care provided to maternal near-miss cases.<xref rid="R5" ref-type="bibr">5</xref> Based on the findings of the case review, actions for improving quality of care are proposed and agreed by hospital staff.<xref rid="R5" ref-type="bibr">5</xref> Beside reviewing clinical management, the NMCR can cover other domains involved with care delivery, including availability of essential equipment, staffing, training, policies and organisation of services.<xref rid="R5" ref-type="bibr">5</xref> The bottom-up approach of the NMCR aims at ensuring local ownership and at facilitating team-building dynamics.<xref rid="R5" ref-type="bibr">5</xref></p><p>The NMCR have been promoted in the last 20 years as a way to audit case management more acceptable for health workers than mortality audits.<xref rid="R4" ref-type="bibr">4–6</xref> In most facilities, the number of maternal deaths is usually insufficient or not representative enough to allow reliable policy guidance.<xref rid="R4" ref-type="bibr">4</xref> Near-miss cases occur more frequently than maternal deaths and their review can inform on both strengths and weaknesses in the process of care. Moreover, discussing cases of deaths may have legal implication and may be perceived as challenging by hospital staff,<xref rid="R4" ref-type="bibr">4</xref> while the review of near-miss cases has showed an overall higher acceptability.<xref rid="R4" ref-type="bibr">4–6</xref></p><p>A systematic review highlighted that the implementation of the NMCR cycle may significantly decrease maternal mortality (OR 0.77, 95% CI 0.61 to 0.98) in high burden countries and can improve quality of care when measured against predefined standards.<xref rid="R7" ref-type="bibr">7</xref> However, a number of challenges hampering successful implementation of the NMCR were also reported.<xref rid="R7" ref-type="bibr">7</xref> Knowledge on factors affecting the successful NMCR implementation can help policy-makers and development partners in better planning the intervention. Given the lack of other reviews exploring this question, the objective of this paper was to systematically synthesise the evidence on facilitators and barriers to effective NMCR implementation in low/middle-income countries (LMICs).</p></sec><sec sec-type="methods" id="s2"><title>Methods</title><sec id="s2a"><title>Search strategy and eligibility criteria</title><p>In conducting this review, we followed the guidelines reported in the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)<xref rid="R8" ref-type="bibr">8</xref> and ENTREQ statement to enhance transparency in reporting of qualitative evidence synthesis<xref rid="R9" ref-type="bibr">9</xref> (see online <xref ref-type="supplementary-material" rid="SP1">supplementary appendices 1 and 2</xref>). A protocol including detailed methods of the review was developed before starting the review.</p><supplementary-material content-type="local-data" id="SP1"><object-id pub-id-type="doi">10.1136/bmjopen-2017-021281.supp1</object-id><label>Supplementary file 1</label><p><inline-supplementary-material id="ss1" xlink:href="bmjopen-2017-021281supp001.pdf" mimetype="application" mime-subtype="pdf" content-type="local-data"></inline-supplementary-material></p></supplementary-material><p>We searched up to December 2017 the following databases, with no language restrictions: MEDLINE through PubMed (from 1956); LILACS through the Virtual Health Library (no date restrictions); Global Health Library (WHO website, no date restrictions); Science Citation Index Expanded (SCI-EXPANDED) and Social Sciences Citation Index (SSCI) through Web of Science (no date restrictions); Cochrane library (no date restrictions) and Embase through OVID (from 1996). The search strategy is reported in <xref ref-type="boxed-text" rid="B1">box 1</xref>. Manual searches of reference lists were also performed.<boxed-text id="B1" position="float" orientation="portrait"><label>Box 1</label><caption><title>Search strategy</title></caption><p><bold>PubMed, Date: 1 December 2017, Total retrieved: 5661</bold></p><p>“near miss” OR (audit AND (obstetric* OR matern* OR pregnan* OR woman OR women))</p><p><bold>Lilacs, Date: 1 December 2017, Total retrieved: 231</bold></p><p>(TW:near miss OR MH:near miss) OR ((TW:audit OR MH:audit OR TW:auditoria OR MH:auditoria OR auditoría) AND (gravid$ OR pregnan$ OR enceint$ OR embarazad$ OR obstetr$ OR mulher$ OR mujer$ OR femme$ OR woman OR women OR matern$))</p><p><bold>Global Idex Medicus Date: 1 December 2017, Total retrieved: 7876</bold></p><p>(TW:near miss OR MH:near miss) OR ((TW:audit OR MH:audit OR TW:auditoria OR MH:auditoria OR auditoría) AND (gravid$ OR pregnan$ OR enceint$ OR embarazad$ OR obstetr$ OR mulher$ OR mujer$ OR femme$ OR woman OR women OR matern$))</p><p><bold>Web of Science Date: 1 December 2017, Total retrieved: 5322</bold></p><p>TS= “near miss” OR (TS=audit AND TS=(gravid* OR pregnan* OR obstetr* OR woman OR women OR matern*))</p><p><bold>Cochrane Library Date: 1 December 2017, Total retrieved: 344</bold></p><p>“near miss” OR (audit AND (gravid* or pregnan* or obstetr* or woman or women or matern*))</p><p><bold>EMBASE Date: 1 December 2017, Total retrieved: 5927</bold></p><list list-type="order"><list-item><p>(“near miss” or audit).ab. (34259)</p></list-item><list-item><p>(obstetric* or matern* or pregnan* or woman or women).ab. (1057153)</p></list-item><list-item><p>1 and 2 (4764)</p></list-item><list-item><p>(“near miss” or audit).ti. (13725)</p></list-item><list-item><p>(obstetric* or matern* or pregnan* or woman or women).ti. (325314)</p></list-item><list-item><p>4 and 5 (724)</p></list-item><list-item><p>3 or 6 (4962)</p></list-item></list></boxed-text></p><p>Studies were eligible for inclusion if they explored facilitators and/or barriers of implementing the NMCR, either by collecting personal views of hospital staff or of patients, in an LMIC (defined as for the World Bank definition<xref rid="R10" ref-type="bibr">10</xref> at the time when the study was conducted). Both studies using the most recent WHO definition of a maternal near-miss case<xref rid="R11" ref-type="bibr">11</xref> developed in year 2011, or locally adapted definitions (such as locally developed disease-specific definitions) were considered for inclusion. Studies reporting facilitators and barriers to effective NMCR implementation merely as the author’s opinion (eg, in the section Discussion) and not as a result of a dedicated analysis were excluded. Abstracts and unpublished technical reports were also not eligible for inclusion. Studies on newborn near-miss cases were not included.</p></sec><sec id="s2b"><title>Data collection and analysis</title><p>Studies were selected for inclusion by two independent researchers. The full text of all eligible citations was examined in detail. Two researchers extracted data from included studies, using a prepiloted data extraction form. Any disagreement was solved via discussion between the two researchers and consensus sought through a third researcher.</p><p>Two authors independently extracted information regarding the study setting, the study sample, methods and tools used for data collection and data analysis. Two authors independently created a spreadsheet with all facilitators and barriers reported in included studies and used thematic analysis methods to conduct initial open coding on each relevant text unit. In the initial round of coding, main emerging themes were synthesised and these were intentionally very broad in order to capture the overarching core themes. As a second step, each theme was further analysed to develop the axial coding scheme. Axial coding is widely accepted in qualitative literature as a sufficient method to disaggregate core themes during qualitative analysis.<xref rid="R12" ref-type="bibr">12–14</xref> Two researchers independently applied the axial codes systematically to the data by hand-sorting the text units into themes and subthemes. Any disagreement on thematic analysis was solved by discussion between the two authors and consensus sought through a third author. Final results are reported in a table, providing the first-order, second-order and third-order themes. Excel and Word were used as software of data extraction.</p><p>The quality of studies was evaluated by two authors independently using the Critical Appraisal Skills Programme (CASP) assessment tool for qualitative studies.<xref rid="R15" ref-type="bibr">15</xref></p><p>Three authors inferred barriers and facilitators reported in the included studies and captured by the descriptive themes, and developed key recommendations for effective NMCR implementation, in line with methods used by previous reviews.<xref rid="R14" ref-type="bibr">14</xref> This process was performed first independently by each author and then as a group until consensus was reached.</p></sec><sec id="s2c"><title>Patient and public involvement</title><p>Patients were not directly involved in this study. However, the development of the research question and outcome measures was informed by patient experience, as previously reported in literature.<xref rid="R2" ref-type="bibr">2–5</xref> For example, in revising studies, we evaluated whether patient views were considered, and the general attitude of service providers towards patients.</p></sec></sec><sec sec-type="results" id="s3"><title>Results</title><sec id="s3a"><title>Characteristics of the studies</title><p>The systematic search yielded a total of 25 361 records (<xref ref-type="fig" rid="F1">figure 1</xref>). Overall, nine studies<xref rid="R16" ref-type="bibr">16–24</xref> met the inclusion criteria (<xref rid="T1" ref-type="table">table 1</xref>). Of these, seven studies were held in countries in the African Region: Benin,<xref rid="R21" ref-type="bibr">21 24</xref> Burkina Faso,<xref rid="R24" ref-type="bibr">24</xref> Cote D’Ivore,<xref rid="R24" ref-type="bibr">24</xref> Ghana,<xref rid="R24" ref-type="bibr">24</xref> Malawi,<xref rid="R20" ref-type="bibr">20</xref> Morocco,<xref rid="R22" ref-type="bibr">22 24</xref> Tanzania<xref rid="R19" ref-type="bibr">19</xref> and Uganda.<xref rid="R16" ref-type="bibr">16</xref> Two reports contributed on one study from Brazil.<xref rid="R17" ref-type="bibr">17 18</xref></p><fig id="F1" orientation="portrait" position="float"><label>Figure 1</label><caption><p>Study flow diagram.</p></caption><graphic xlink:href="bmjopen-2017-021281f01"></graphic></fig><table-wrap id="T1" orientation="portrait" position="float"><label>Table 1</label><caption><p>Study context and population</p></caption><table frame="hsides" rules="groups"><thead><tr><td valign="bottom" align="left" rowspan="1" colspan="1">Study</td><td valign="top" align="left" rowspan="1" colspan="1">Country</td><td valign="top" align="left" rowspan="1" colspan="1">World Bank <break></break>classification*</td><td valign="top" align="left" rowspan="1" colspan="1">Setting</td><td valign="top" align="left" rowspan="1" colspan="1">Hospital (n)</td><td valign="top" align="left" rowspan="1" colspan="1">Hospital type*</td><td valign="top" align="left" rowspan="1" colspan="1">Sample <break></break>staff (n)</td><td valign="top" align="left" rowspan="1" colspan="1">Staff type*</td></tr></thead><tbody><tr><td valign="top" align="left" rowspan="1" colspan="1">Kayiga <italic>et al</italic>, 2016<xref rid="R16" ref-type="bibr">16</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Uganda</td><td valign="top" align="left" rowspan="1" colspan="1">L</td><td valign="top" align="left" rowspan="1" colspan="1">Urban</td><td valign="top" align="char" char="." rowspan="1" colspan="1">1</td><td valign="top" align="left" rowspan="1" colspan="1">Tertiary hospital</td><td valign="top" align="char" char="." rowspan="1" colspan="1">40</td><td valign="top" align="left" rowspan="1" colspan="1">D, I, R</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Gomez Luz <italic>et al</italic>, 2014<xref rid="R17" ref-type="bibr">17</xref><break></break>Gomez Luz <italic>et al</italic>, 2014<xref rid="R18" ref-type="bibr">18</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Brazil</td><td valign="top" align="left" rowspan="1" colspan="1">UM</td><td valign="top" align="left" rowspan="1" colspan="1">Mixed</td><td valign="top" align="char" char="." rowspan="1" colspan="1">27</td><td valign="top" align="left" rowspan="1" colspan="1">Mixed (all teaching hospitals but 5 secondary level, 22 tertiary level)</td><td valign="top" align="char" char="." rowspan="1" colspan="1">122</td><td valign="top" align="left" rowspan="1" colspan="1">C, PI, MA</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Hamersveld <italic>et al</italic>, 2012<xref rid="R19" ref-type="bibr">19</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Tanzania</td><td valign="top" align="left" rowspan="1" colspan="1">L</td><td valign="top" align="left" rowspan="1" colspan="1">Rural</td><td valign="top" align="char" char="." rowspan="1" colspan="1">1</td><td valign="top" align="left" rowspan="1" colspan="1">District hospital</td><td valign="top" align="char" char="." rowspan="1" colspan="1">23</td><td valign="top" align="left" rowspan="1" colspan="1">D, C, M, N, MA</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Bakker <italic>et al</italic>, 2011<xref rid="R20" ref-type="bibr">20</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Malawi</td><td valign="top" align="left" rowspan="1" colspan="1">L</td><td valign="top" align="left" rowspan="1" colspan="1">Mixed</td><td valign="top" align="char" char="." rowspan="1" colspan="1">2</td><td valign="top" align="left" rowspan="1" colspan="1">Mixed (one district, one rural hospital)</td><td valign="top" align="char" char="." rowspan="1" colspan="1">33</td><td valign="top" align="left" rowspan="1" colspan="1">D, N, M</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Hutchinson <italic>et al</italic>, 2010<xref rid="R21" ref-type="bibr">21</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Benin</td><td valign="top" align="left" rowspan="1" colspan="1">L</td><td valign="top" align="left" rowspan="1" colspan="1">Mixed</td><td valign="top" align="char" char="." rowspan="1" colspan="1">5</td><td valign="top" align="left" rowspan="1" colspan="1">Mixed (two national university hospitals, one regional, one district, one missionary</td><td valign="top" align="char" char="." rowspan="1" colspan="1">10</td><td valign="top" align="left" rowspan="1" colspan="1">MA, HW</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Muffler <italic>et al</italic>, 2007<xref rid="R22" ref-type="bibr">22</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Morocco</td><td valign="top" align="left" rowspan="1" colspan="1">LM</td><td valign="top" align="left" rowspan="1" colspan="1">Mixed</td><td valign="top" align="char" char="." rowspan="1" colspan="1">13</td><td valign="top" align="left" rowspan="1" colspan="1">Mixed</td><td valign="top" align="char" char="." rowspan="1" colspan="1">56</td><td valign="top" align="left" rowspan="1" colspan="1">MA, M, N, D, I, C, R</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Richard <italic>et al</italic>, 2008<xref rid="R23" ref-type="bibr">23</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Burkina Faso</td><td valign="top" align="left" rowspan="1" colspan="1">L</td><td valign="top" align="left" rowspan="1" colspan="1">Urban</td><td valign="top" align="char" char="." rowspan="1" colspan="1">1</td><td valign="top" align="left" rowspan="1" colspan="1">District hospital</td><td valign="top" align="char" char="." rowspan="1" colspan="1">35</td><td valign="top" align="left" rowspan="1" colspan="1">D, M, N</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Filippi, 2004<xref rid="R24" ref-type="bibr">24</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Benin, Cote D’Ivore, Ghana, Morocco</td><td valign="top" align="left" rowspan="1" colspan="1">L, L, L, LM</td><td valign="top" align="left" rowspan="1" colspan="1">Urban</td><td valign="top" align="char" char="." rowspan="1" colspan="1">12</td><td valign="top" align="left" rowspan="1" colspan="1">Mixed (first level in Morocco, more specialised in other countries)</td><td valign="top" align="char" char="." rowspan="1" colspan="1">162</td><td valign="top" align="left" rowspan="1" colspan="1">D, M, I, N</td></tr></tbody></table><table-wrap-foot><fn id="tblfn1"><p>*L, low income; LM, lower middle income; UM, upper middle income (countries are classified based on the years when the study was performed).</p></fn><fn id="tblfn2"><p>C, coordinator, D, doctors, I, in charge; HW, health workers; I, investigators; M, midwives; MA, manager; n, nurses; PI, principal investigator; R, resident.</p></fn></table-wrap-foot></table-wrap><p>Most studies were conducted in low-income countries, with the exception of the studies in Morocco and Brazil (middle-income countries). Three studies were conducted in an urban setting,<xref rid="R16" ref-type="bibr">16 23 24</xref> one in a rural area,<xref rid="R19" ref-type="bibr">19</xref> four in a mixed setting<xref rid="R17" ref-type="bibr">17 20–22</xref> and one not clarified this information. Overall, there were four large-to-middle-sized studies including a conspicuous number of hospitals: 27 maternities in the Brazilian study<xref rid="R17" ref-type="bibr">17 18</xref>; 13 facilities in a study in Morocco<xref rid="R22" ref-type="bibr">22</xref>; 12 hospitals in a multicountry study<xref rid="R24" ref-type="bibr">24</xref> and 5 in a study from Benin.<xref rid="R21" ref-type="bibr">21</xref> One study in Malawi included two hospitals,<xref rid="R20" ref-type="bibr">20</xref> while the remaining three studies included one single facility.<xref rid="R16" ref-type="bibr">16 19 23</xref> Number of staff interviewed (and/or included in the focus group) varied from a maximum of 162 people<xref rid="R24" ref-type="bibr">24</xref> to a minimum of 10.<xref rid="R21" ref-type="bibr">21</xref> All studies collected the views of hospital staff, while none reported the views of patients.</p><p>In terms of methodology (<xref rid="T2" ref-type="table">table 2</xref>), most studies were conducted 1–2 years after the start of the NMCR implementation, with only two studies<xref rid="R21" ref-type="bibr">21 22</xref> being performed several years after. All studies used interviews as the main tool for data collection. In addition, two evaluations used focus group discussion,<xref rid="R16" ref-type="bibr">16 20</xref> three used direct observation of the NMCR session<xref rid="R19" ref-type="bibr">19 20 24</xref> and two evaluated notes from the NMCR sessions and other related documents.<xref rid="R23" ref-type="bibr">23 24</xref> Five studies explicitly stated that the investigation was conducted by a researcher who was external from the study context,<xref rid="R17" ref-type="bibr">17 20 21 23 24</xref> while the others did not fully clarify the relationship between the interviewer and the participants. Other methods related to data collection and analyses are reported in <xref rid="T2" ref-type="table">table 2</xref>.</p><table-wrap id="T2" orientation="portrait" position="float"><label>Table 2</label><caption><p>Study methods</p></caption><table frame="hsides" rules="groups"><thead><tr><td valign="top" align="left" rowspan="1" colspan="1">Author</td><td valign="top" align="left" rowspan="1" colspan="1">Timing in respect of NMCR start</td><td valign="top" align="left" rowspan="1" colspan="1">Methods and tools</td><td valign="top" align="left" rowspan="1" colspan="1">Who performed the evaluation?</td><td valign="top" align="left" rowspan="1" colspan="1">Other methods related to data collection</td><td valign="top" align="left" rowspan="1" colspan="1">Other methods related to data analysis</td></tr></thead><tbody><tr><td valign="top" align="left" rowspan="1" colspan="1">Kayiga <italic>et al</italic>, 2016<xref rid="R16" ref-type="bibr">16</xref></td><td valign="top" align="left" rowspan="1" colspan="1">During NMCR implementation</td><td valign="top" align="left" rowspan="1" colspan="1">Interviews+three focus groups</td><td valign="top" align="left" rowspan="1" colspan="1">NR</td><td valign="top" align="left" rowspan="1" colspan="1">Open-ended questions. Midwives, doctors and residents involved in focus group separately.</td><td valign="top" align="left" rowspan="1" colspan="1">All data were transcribed coded and analysed by thematic analysis.</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Gomez Luz <italic>et al</italic>, 2014<xref rid="R17" ref-type="bibr">17</xref><break></break>Gomez Luz <italic>et al</italic>, 2014<xref rid="R18" ref-type="bibr">18</xref></td><td valign="top" align="left" rowspan="1" colspan="1">6 and 12 months after start of implementation</td><td valign="top" align="left" rowspan="1" colspan="1">Semistructured telephone interviews</td><td valign="top" align="left" rowspan="1" colspan="1">Interviewers skilled in how to conduct telephone surveys were specifically trained for the study</td><td valign="top" align="left" rowspan="1" colspan="1">Pretested tool for guiding the interviews. At least six attempts made to contact each potential subject. When telephone contact was unsuccessful, messages were sent by email. The interviews were conducted by phone, after informed consent, and simultaneously recorded.</td><td valign="top" align="left" rowspan="1" colspan="1">The NVivo software program was used to codify the interviews, organise and analyse the qualitative data. Thematic content analysis was conducted by two authors and reviewed by two other authors. Quotations from the transcripts were used to illustrate the results presented.</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Hamersveld <italic>et al</italic>, 2012<xref rid="R19" ref-type="bibr">19</xref></td><td valign="top" align="left" rowspan="1" colspan="1">2 years after implementation</td><td valign="top" align="left" rowspan="1" colspan="1">In-depth interviews+observation +</td><td valign="top" align="left" rowspan="1" colspan="1">Two study authors</td><td valign="top" align="left" rowspan="1" colspan="1">A semistructured interview guide based on earlier studies. Participants conveniently selected. Interviews conducted in Swahili for those who could not express themselves in English. During the study period, points of key interest were analysed and used to refine questions and elaborate on certain areas while maintaining the structure of the interview guide.</td><td valign="top" align="left" rowspan="1" colspan="1">The recording was transcribed manually and then analysed by using inductive coding. All interviews in Swahili were recorded, transcribed and translated into English. Further analysis grouped the codes into categories and cross-links within the data as well as between data, and literature were identified. Two authors independently analysed the data, after which results were compared.</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Bakker <italic>et al</italic>, 2011<xref rid="R20" ref-type="bibr">20</xref></td><td valign="top" align="left" rowspan="1" colspan="1">After national institutionalisation of NMCR and during an impact study</td><td valign="top" align="left" rowspan="1" colspan="1">Semistructured interviews, focus groups, observation and key informant interviews</td><td valign="top" align="left" rowspan="1" colspan="1">Independent primary investigator not part of the hospital staff</td><td valign="top" align="left" rowspan="1" colspan="1">Interviews: semistructured questionnaire previously used for another study and probed for critical views; convenience and snowball sampling; the inclusion criterion for participants was regular involvement with obstetric healthcare in the district. <break></break>Focus groups: conducted towards the end of the study period to complement interviews.</td><td valign="top" align="left" rowspan="1" colspan="1">All data were literally transcribed, using Express Scribe transcription software. Relevant data were entered into Microsoft Excel. Analysis and statement coding were performed using MAXQDA 2010 software.</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Hutchinson <italic>et al</italic>, 2012<xref rid="R21" ref-type="bibr">21</xref></td><td valign="top" align="left" rowspan="1" colspan="1">7 years after start of NMCR implementation</td><td valign="top" align="left" rowspan="1" colspan="1">Semistructured interviews</td><td valign="top" align="left" rowspan="1" colspan="1">First author, a local researcher not involved in the NMCR implementation and not known by participants</td><td valign="top" align="left" rowspan="1" colspan="1">A literature review informed the development of a semistructured interview guide. Open-ended questions allowed participants to address issues important to them. The guide was translated into French and modified following advice by local scientists. Participants were selected randomly ensuring inclusion of a range of professional backgrounds. All interviews were conducted in French, transcribed and translated in English.</td><td valign="top" align="left" rowspan="1" colspan="1">Transcripts were read numerous times in order to become familiar with emerging themes. <break></break>Framework analysis was used to provide a systematic approach for coding themes.</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Muffler <italic>et al</italic>, 2007<xref rid="R22" ref-type="bibr">22</xref></td><td valign="top" align="left" rowspan="1" colspan="1">About 10–12 years after start of implementation</td><td valign="top" align="left" rowspan="1" colspan="1">Self-administered questionnaire+semistructured interviews</td><td valign="top" align="left" rowspan="1" colspan="1">NR</td><td valign="top" align="left" rowspan="1" colspan="1">A self-administered questionnaire was sent to 84 public maternities to identify those implementing the audits. All but one maternity units were visited. Semistructured interviews were conducted individually. In addition, locally available data on audit activity was gathered from audit reports and overviews were systematically reviewed and compared with data gathered in the interviews.</td><td valign="top" align="left" rowspan="1" colspan="1">Interview data were analysed using systematic content analysis.</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Richard <italic>et al</italic>, 2008<xref rid="R23" ref-type="bibr">23</xref></td><td valign="top" align="left" rowspan="1" colspan="1">About 1 year after start of the implementation</td><td valign="top" align="left" rowspan="1" colspan="1">Questionnaire+reviews of notes from audit sessions</td><td valign="top" align="left" rowspan="1" colspan="1">Research midwife, not part of the hospital staff</td><td valign="top" align="left" rowspan="1" colspan="1">A pretested questionnaire was used. It contained closed and open-ended questions, and it was administrated face to face by a single interviewer.</td><td valign="top" align="left" rowspan="1" colspan="1">Data were analysed using a qualitative and quantitative approach. Answers from open-ended questions were coded. Answers were then grouped according to themes to build tables. Two authors conducted the analysis.</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Filippi <italic>et al</italic>, 2004<xref rid="R24" ref-type="bibr">24</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Few years after start of implementation</td><td valign="top" align="left" rowspan="1" colspan="1">Interviews+observation of sessions+ documents review</td><td valign="top" align="left" rowspan="1" colspan="1">Local researchers, externally supported by international team</td><td valign="top" align="left" rowspan="1" colspan="1">NR</td><td valign="top" align="left" rowspan="1" colspan="1">NR</td></tr></tbody></table><table-wrap-foot><fn id="tblfn3"><p>NMCR, near-miss case review; NR, not further reported.</p></fn></table-wrap-foot></table-wrap><p>Quality of the studies according to the CASP criteria is reported in <xref rid="T3" ref-type="table">table 3</xref>. Three studies matched all criteria for quality and were rated as ‘high quality’,<xref rid="R17" ref-type="bibr">17 21 23</xref> while the remaining studies were rated as of moderate quality.<xref rid="R16" ref-type="bibr">16 19 20 22 24</xref></p><table-wrap id="T3" orientation="portrait" position="float"><label>Table 3</label><caption><p>Quality assessment of studies</p></caption><table frame="hsides" rules="groups"><thead><tr><td valign="bottom" align="left" rowspan="1" colspan="1">Study</td><td valign="top" align="left" rowspan="1" colspan="1">Clear statement of the aims of the research</td><td valign="top" align="left" rowspan="1" colspan="1">Qualitative methodology appropriate</td><td valign="top" align="left" rowspan="1" colspan="1">Research design appropriate to address the aims of the research</td><td valign="top" align="left" rowspan="1" colspan="1">Recruitment strategy appropriate</td><td valign="top" align="left" rowspan="1" colspan="1">Data collected to address the research issue</td><td valign="top" align="left" rowspan="1" colspan="1">Relationship between researcher and participants adequately considered</td><td valign="top" align="left" rowspan="1" colspan="1">Have ethical issues been taken into consideration?</td><td valign="top" align="left" rowspan="1" colspan="1">Data analysis sufficiently rigorous</td><td valign="top" align="left" rowspan="1" colspan="1">Clear statement of findings</td><td valign="top" align="left" rowspan="1" colspan="1">Is the research valuable?</td></tr></thead><tbody><tr><td valign="top" align="left" rowspan="1" colspan="1">Kayiga <italic>et al</italic>, 2016<xref rid="R16" ref-type="bibr">16</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Can’t tell *</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Can’t tell *</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Gomez Luz <italic>et al</italic>, 2014<xref rid="R17" ref-type="bibr">17 18</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Hamersveld <italic>et al</italic>, 2012<xref rid="R19" ref-type="bibr">19</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Can’t tell *</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Can’t tell *</td><td valign="top" align="left" rowspan="1" colspan="1">Partly †</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Bakker <italic>et al</italic>, 2011<xref rid="R20" ref-type="bibr">20</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Partly ‡</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Hutchinson <italic>et al</italic>, 2010<xref rid="R21" ref-type="bibr">21</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Muffler <italic>et al</italic>, 2007<xref rid="R22" ref-type="bibr">22</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Partly §</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Richard 2008 <italic>et al,</italic><xref rid="R23" ref-type="bibr">23</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Filippi <italic>et al</italic>, 2004<xref rid="R24" ref-type="bibr">24</xref>§</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Can’t tell *</td><td valign="top" align="left" rowspan="1" colspan="1">Can’t tell *</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td><td valign="top" align="left" rowspan="1" colspan="1">Y</td></tr></tbody></table><table-wrap-foot><fn id="tblfn4"><p>*Not enough information provided in the paper.</p></fn><fn id="tblfn5"><p>†Participants’ informed verbal consent was obtained for each interview and for the use of a tape recording. Participants’ anonymity was protected by keeping the tape records and written information confidential.</p></fn><fn id="tblfn6"><p>‡Participants were conveniently selected.</p></fn><fn id="tblfn7"><p>§The National Health Sciences Research Committee of the Government of Malawi qualified the study as ‘operational research’ and did not require formal ethical approval, because it involved the evaluation of routine clinical practice only. Participants were informed about the study background and objectives and permission was asked to tape-record. It was made clear that information would be anonymously transcribed and reported by the primary investigator and that his reports could not be traced to individuals.</p></fn></table-wrap-foot></table-wrap></sec><sec id="s3b"><title>Barriers and facilitators</title><p><xref rid="T4" ref-type="table">Table 4</xref> synthesises the first-order, second-order and third-order themes identified. Factors were divided into national-level factors, facility-level factors and external partners factors.</p><table-wrap id="T4" orientation="portrait" position="float"><label>Table 4</label><caption><p>Results of the thematic analysis</p></caption><table frame="hsides" rules="groups"><thead><tr><td valign="top" align="left" rowspan="1" colspan="1">Third order</td><td valign="top" align="left" rowspan="1" colspan="1">Second order</td><td valign="top" align="left" rowspan="1" colspan="1">First order</td><td valign="top" align="left" rowspan="1" colspan="1">Facilitators</td><td valign="top" align="left" rowspan="1" colspan="1">Barriers</td></tr></thead><tbody><tr><td valign="top" rowspan="2" align="left" colspan="1">National level factors</td><td valign="top" rowspan="2" align="left" colspan="1">Leadership and coordination mechanisms</td><td valign="top" align="left" rowspan="1" colspan="1">Guidelines and standards</td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1">Absence of national case management protocols<xref rid="R16" ref-type="bibr">16</xref></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">NMCR implementation</td><td valign="top" align="left" rowspan="1" colspan="1">Commitment of health authorities<xref rid="R20" ref-type="bibr">20</xref><break></break>Effective task allocation<xref rid="R17" ref-type="bibr">17</xref><break></break>Effective coordination<xref rid="R24" ref-type="bibr">24</xref><break></break>Standard form for reporting<xref rid="R17" ref-type="bibr">17 21</xref><break></break>Effective monitoring and quality assessment<xref rid="R17" ref-type="bibr">17 21</xref><break></break>Commitment to training<xref rid="R20" ref-type="bibr">20</xref><break></break>Integrating audits into the curricula of medical and midwifery schools<xref rid="R21" ref-type="bibr">21</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Absence of directives from the health authority<xref rid="R22" ref-type="bibr">22</xref><break></break>Pressures of competing programme activities<xref rid="R21" ref-type="bibr">21</xref><break></break>Clashing interests of health authorities compared with those of health providers<xref rid="R22" ref-type="bibr">22</xref></td></tr><tr><td valign="top" rowspan="5" align="left" colspan="1">Facility level factors</td><td valign="top" rowspan="5" align="left" colspan="1">Policies and coordination mechanisms</td><td valign="top" align="left" rowspan="1" colspan="1">Standards</td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1">Absence of management protocols<xref rid="R16" ref-type="bibr">16</xref></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Training</td><td valign="top" align="left" rowspan="1" colspan="1">Training of all key staff<xref rid="R17" ref-type="bibr">17 19 21</xref><break></break>Obstetricians’ and midwives’ involvement in safe motherhood initiatives<xref rid="R21" ref-type="bibr">21</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Training of single people<xref rid="R22" ref-type="bibr">22</xref></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Leadership and coordination of audit sessions</td><td valign="top" align="left" rowspan="1" colspan="1">Good leadership<xref rid="R17" ref-type="bibr">17 21</xref><break></break>Managerial support<xref rid="R19" ref-type="bibr">19 21</xref><break></break>Written management policy<xref rid="R17" ref-type="bibr">17 21</xref><break></break>Convincing explanations on the importance of audits<xref rid="R17" ref-type="bibr">17</xref><break></break>Introduction of new clinical guidelines together with audits<xref rid="R17" ref-type="bibr">17 23</xref><break></break>Dedicated and permanent chairperson<xref rid="R20" ref-type="bibr">20</xref><break></break>Involvement of a variety of staff and managers<xref rid="R19" ref-type="bibr">19 20</xref><break></break>Presence at the session of the health workers involved in the case<xref rid="R20" ref-type="bibr">20</xref><break></break>Case discussion conducted openly, fairly and with decent manners<xref rid="R19" ref-type="bibr">19 20</xref><break></break>Focusing also on positive aspects of care<xref rid="R20" ref-type="bibr">20</xref><break></break>Cases discussed in an anonymous way<xref rid="R23" ref-type="bibr">23</xref><break></break>Balance between the expectations and engagement from both providers and administrators<xref rid="R22" ref-type="bibr">22</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Poor understanding, management and participations from leaders<xref rid="R17" ref-type="bibr">17 19 21 22</xref><break></break>Managers failing to show that the aim of audit is not finding the guilty party<xref rid="R21" ref-type="bibr">21 22</xref><break></break>Lack of task allocation<xref rid="R16" ref-type="bibr">16</xref><break></break>Lack of inclusion of all staff<xref rid="R19" ref-type="bibr">19 21</xref><break></break>Case selection bias<xref rid="R23" ref-type="bibr">23</xref><break></break>The audit highlighted only the negative aspects of case management<xref rid="R23" ref-type="bibr">23</xref><break></break>Blaming and/or use of harsh language, threatening, repressive attitude<xref rid="R19" ref-type="bibr">19–23</xref><break></break>Loss of confidentiality and/or pointing out explicitly who made a mistake<xref rid="R20" ref-type="bibr">20 23</xref><break></break>Underestimation of resources needed<xref rid="R21" ref-type="bibr">21</xref><break></break>Delay of release of funds<xref rid="R16" ref-type="bibr">16</xref><break></break>Managers’ reluctance in attending meetings<xref rid="R24" ref-type="bibr">24</xref><break></break>Centralised decision-making<xref rid="R23" ref-type="bibr">23</xref></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Monitoring and supervision</td><td valign="top" align="left" rowspan="1" colspan="1">Political and/or institutional commitment and active coordination<xref rid="R17" ref-type="bibr">17 22</xref><break></break>Standardised forms for reporting<xref rid="R17" ref-type="bibr">17</xref><break></break>Structured action plans with transparent information to all staff<xref rid="R19" ref-type="bibr">19 20 24</xref><break></break>Constant monitoring and periodic quality assessment<xref rid="R17" ref-type="bibr">17</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Lack of follow-up on recommendations<xref rid="R16" ref-type="bibr">16 19 20 23</xref><break></break>Lack of transparent results diffusions and provision of feedback<xref rid="R16" ref-type="bibr">16 19 20</xref></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Incentives</td><td valign="top" align="left" rowspan="1" colspan="1">Role and recognition<xref rid="R22" ref-type="bibr">22 24</xref><break></break>Economic incentives<xref rid="R21" ref-type="bibr">21 24</xref><break></break>Purchase of necessary essential equipment<xref rid="R21" ref-type="bibr">21</xref></td><td valign="top" align="left" rowspan="1" colspan="1">No reward nor economic incentive, in settings with low salaries<xref rid="R21" ref-type="bibr">21–23</xref><break></break>Low resources available to implement recommendations<xref rid="R24" ref-type="bibr">24</xref></td></tr><tr><td valign="top" rowspan="4" align="left" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1">Resource availability</td><td valign="top" align="left" rowspan="1" colspan="1">Human resources, essentials equipment and supplies</td><td valign="top" align="left" rowspan="1" colspan="1">Adequate human and material resources<xref rid="R19" ref-type="bibr">19 22</xref><break></break>Proper documentation<xref rid="R19" ref-type="bibr">19</xref></td><td valign="top" align="left" rowspan="1" colspan="1">High patient workload, shortage of staff<xref rid="R16" ref-type="bibr">16 17 19–22 24</xref><break></break>Staff absenteeism<xref rid="R19" ref-type="bibr">19 20</xref> and/or high staff turnover<xref rid="R21" ref-type="bibr">21</xref><break></break>Shortage of equipment and supplies, including stationery<xref rid="R16" ref-type="bibr">16 19 23</xref><break></break>Insufficient record-keeping<xref rid="R17" ref-type="bibr">17 19</xref><break></break>Underestimation of resources needed<xref rid="R21" ref-type="bibr">21</xref><break></break>Low morale among staff desiring to leave work<xref rid="R16" ref-type="bibr">16</xref></td></tr><tr><td valign="top" rowspan="3" align="left" colspan="1">Sociocultural environment</td><td valign="top" align="left" rowspan="1" colspan="1">Culture and practice of quality improvement</td><td valign="top" align="left" rowspan="1" colspan="1">Blame-free environment<xref rid="R19" ref-type="bibr">19</xref><break></break>Attitude towards self-criticism<xref rid="R22" ref-type="bibr">22</xref><break></break>Positive attitude towards audit and feedback<xref rid="R20" ref-type="bibr">20</xref><break></break>Being a teaching hospital associated with research<xref rid="R17" ref-type="bibr">17</xref><break></break>Health staff willingness to improve quality of care<xref rid="R23" ref-type="bibr">23</xref><break></break>Good case notes perceived as helpful in protecting staff in a legal context<xref rid="R22" ref-type="bibr">22</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Culture of blaming, fear and individual punishment<xref rid="R16" ref-type="bibr">16 19–22</xref><break></break>Lack of knowledge on principles and methods of audits<xref rid="R17" ref-type="bibr">17 22</xref><break></break>Audit not perceived as part of duties<xref rid="R17" ref-type="bibr">17 21</xref><break></break>Audits perceived as a way of controlling staff<xref rid="R23" ref-type="bibr">23</xref><break></break>Lack of knowledge and/or interest in quality improvement<xref rid="R17" ref-type="bibr">17</xref><break></break>Inadequate knowledge of evidenced-based medicine<xref rid="R17" ref-type="bibr">17 19 22</xref><break></break>Difficulty from staff to feel questioned about own work<xref rid="R17" ref-type="bibr">17 19 23</xref><break></break>Attitude in finding excuses and not revealing the truth<xref rid="R19" ref-type="bibr">19 21</xref></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Hierarchy, cultural norms among health staff and interpersonal relationship</td><td valign="top" align="left" rowspan="1" colspan="1">Good practices of communication and cooperation between staff<xref rid="R19" ref-type="bibr">19 22</xref><break></break>Possibility to challenge staff of higher grade<xref rid="R19" ref-type="bibr">19</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Hierarchical differences<xref rid="R16" ref-type="bibr">16</xref><break></break>Nurses, midwives and doctors working separately<xref rid="R16" ref-type="bibr">16</xref><break></break>Doctors behaving as superior<xref rid="R16" ref-type="bibr">16 22</xref><break></break>Lack of assertiveness among mid-level staff<xref rid="R17" ref-type="bibr">17 19 20</xref><break></break>Personnel not being used to speak in public, fear of people higher in rank<xref rid="R17" ref-type="bibr">17 19</xref><break></break>Disrespectable manners towards lower level staff<xref rid="R20" ref-type="bibr">20</xref><break></break>Previously existing conflicts at interpersonal level<xref rid="R22" ref-type="bibr">22</xref><break></break>Lack of external support to facilitate dynamics<xref rid="R22" ref-type="bibr">22</xref></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Attitude towards patients</td><td valign="top" align="left" rowspan="1" colspan="1">Empowered patients<xref rid="R16" ref-type="bibr">16</xref><break></break>Health staff passion and an attitude of caring for patients<xref rid="R16" ref-type="bibr">16 17</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Difficulty of accepting professional responsibility<xref rid="R22" ref-type="bibr">22</xref><break></break>Poor attention low priority given to some conditions (eg, obstructed labour)<xref rid="R16" ref-type="bibr">16</xref><break></break>Low commitment to serve/work<xref rid="R16" ref-type="bibr">16</xref></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1">Outputs and outcomes</td><td valign="top" align="left" rowspan="1" colspan="1">Audit impacts</td><td valign="top" align="left" rowspan="1" colspan="1">Positive impact of audits on quality of care<xref rid="R21" ref-type="bibr">21</xref><break></break>Positive impact of audits on health staff<xref rid="R20" ref-type="bibr">20–22 24</xref></td><td valign="top" align="left" rowspan="1" colspan="1">Lack of evidence or clarity about what the audit is and on its effectiveness<xref rid="R19" ref-type="bibr">19 22</xref></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">External factors</td><td valign="top" align="left" rowspan="1" colspan="1">Sustained support</td><td valign="top" align="left" rowspan="1" colspan="1">Availability</td><td valign="top" align="left" rowspan="1" colspan="1">External body providing technical support and/or required resources<xref rid="R21" ref-type="bibr">21 22 24</xref></td><td valign="top" align="left" rowspan="1" colspan="1"></td></tr></tbody></table><table-wrap-foot><fn id="tblfn8"><p>NMCR, near-miss case review.</p></fn></table-wrap-foot></table-wrap><sec id="s3b1"><title>National level factors</title><sec id="s3b1a"><title>National standards</title><p>Absence of national case management protocols<xref rid="R16" ref-type="bibr">16</xref> was reported as a barrier to the effective implementation of NMCR.</p></sec><sec id="s3b1b"><title>Leadership and coordination mechanisms</title><p>Facilitators of effective NMCR implementation described by health workers included general commitment of health authorities<xref rid="R20" ref-type="bibr">20</xref> and the establishment of effective coordination mechanisms, such as effective task allocation,<xref rid="R17" ref-type="bibr">17</xref> networking support among facilities,<xref rid="R24" ref-type="bibr">24</xref> availability of a standard form for reporting,<xref rid="R21" ref-type="bibr">21</xref> effective monitoring and quality assessment.<xref rid="R17" ref-type="bibr">17 21</xref> Commitment to training<xref rid="R20" ref-type="bibr">20</xref> and integration of audits into medical and midwifery school curricula<xref rid="R21" ref-type="bibr">21</xref> were also reported as facilitators.</p><p>Barriers to effective NMCR implementation included absence of directives from health authority<xref rid="R22" ref-type="bibr">22</xref> and pressure from competing programme activities or interests.<xref rid="R21" ref-type="bibr">21 22</xref></p></sec></sec><sec id="s3b2"><title>Facility level factors</title><sec id="s3b2a"><title>National guidelines and standards</title><p>Absence of case management protocols<xref rid="R16" ref-type="bibr">16</xref> at facility level was reported as key barrier in implementing the NMCR.<xref rid="R16" ref-type="bibr">16</xref></p></sec><sec id="s3b2b"><title>Training</title><p>Training of all key staff and managers on the principles, importance and methodology of the NMCR<xref rid="R17" ref-type="bibr">17 19 21</xref> was reported as key factor facilitating their implementation. In addition, programmes to strengthen involvement of obstetricians and midwives in safe motherhood initiatives<xref rid="R21" ref-type="bibr">21</xref> were reported as useful.</p><p>On the other side, however, training a limited number of people (most often, only the local coordinator/facilitator) meant there was a risk of the process to be entirely dependent on the availability of that single person<xref rid="R22" ref-type="bibr">22</xref> and this was noted as a barrier.</p></sec><sec id="s3b2c"><title>Leadership and coordination of audit sessions</title><p>A list of factors related to leadership and coordination was reported as facilitators to case reviews: good leadership<xref rid="R17" ref-type="bibr">17 21</xref>; managerial support<xref rid="R19" ref-type="bibr">19 21</xref>; existence of a written management policy<xref rid="R17" ref-type="bibr">17 21</xref>; clear and convincing explanation on the importance of audits<xref rid="R17" ref-type="bibr">17</xref>; leadership for the introduction of new clinical guidelines as opposed to audits only<xref rid="R17" ref-type="bibr">17 23</xref>; availability of a dedicated and permanent chairperson<xref rid="R20" ref-type="bibr">20</xref>; involvement of a variety of staff and managers in all stages of audit, with unrestricted admission to sessions<xref rid="R19" ref-type="bibr">19 20</xref>; attendance to the session of the health workers who had been involved in the case management<xref rid="R20" ref-type="bibr">20</xref>; case discussion conducted openly and fairly with participants maintaining respect and good manners towards each other<xref rid="R19" ref-type="bibr">19 20</xref>; focus also on positive aspects of care<xref rid="R20" ref-type="bibr">20</xref>; case discussion conducted in an anonymous way<xref rid="R23" ref-type="bibr">23</xref> and finally a balance between the expectations and engagement from both providers and administrators.<xref rid="R22" ref-type="bibr">22</xref></p><p>Similarly, a list of barriers related to leadership and coordination was reported, such as poor understanding from leaders of the NMCR process; poor leadership and lack of involvement of directors<xref rid="R17" ref-type="bibr">17 19 21 22</xref>; failure from managers in recognising that the NMCR aim is not finding who is guilty, but rather improving services<xref rid="R21" ref-type="bibr">21 22</xref>; lack of task allocation<xref rid="R16" ref-type="bibr">16</xref>; lack of inclusion of all types of staff (eg, midwives, laboratory services) and poor participation of certain type of staff (eg, doctors or low-level staff not attending or attending irregularly)<xref rid="R19" ref-type="bibr">19 21</xref>; case selection bias (eg, selecting only cases where mid-level staff, but not doctors, committed mistakes)<xref rid="R23" ref-type="bibr">23</xref>; highlighting only the negative aspects of case management<xref rid="R23" ref-type="bibr">23</xref>; blaming and/or using harsh language or bossing attitude<xref rid="R19" ref-type="bibr">19–23</xref>; loss of confidentiality during the sessions<xref rid="R23" ref-type="bibr">23</xref>; managers reluctance to attend meetings for fear of requests they cannot fulfil.<xref rid="R24" ref-type="bibr">24</xref> Other barriers included delay in releasing funds<xref rid="R16" ref-type="bibr">16</xref> and centralised human resources management and decision-making inhibiting initiatives by the clinicians.<xref rid="R23" ref-type="bibr">23</xref></p></sec><sec id="s3b2d"><title>Monitoring and supervision</title><p>Political and/or institutional commitment in monitoring and supervision, active coordination of accountability mechanisms,<xref rid="R17" ref-type="bibr">17 22</xref> together with the availability of standardised forms for reporting,<xref rid="R17" ref-type="bibr">17</xref> structured action plans to implement the NMCR recommendations with transparent information to all staff members,<xref rid="R19" ref-type="bibr">19 20 24</xref> effective monitoring, periodic quality assessment and networking of local teams to a central coordinating centre<xref rid="R17" ref-type="bibr">17</xref> were reported by staff as facilitators of the NMCR implementation.</p><p>On the other side, lack of follow-up on recommendations<xref rid="R16" ref-type="bibr">16 19 20 23</xref> and lack of transparent results dissemination and provision of feedback<xref rid="R16" ref-type="bibr">16 19 20</xref> were cited as barriers.</p></sec><sec id="s3b2e"><title>Incentives</title><p>Incentives such as appointing a role<xref rid="R22" ref-type="bibr">22 24</xref> or providing some form of recognition such as economic incentives for participating in the audit sessions,<xref rid="R21" ref-type="bibr">21 24</xref> and purchasing necessary essential equipment as recommended from the case reviews<xref rid="R21" ref-type="bibr">21</xref> were observed as important factors to allow NMCR sustainability over time.</p><p>On the contrary, the absence of a reward or of an economic incentive, even if minimal, in setting with low salaries and high inflation,<xref rid="R21" ref-type="bibr">21–23</xref> together with the low resources available to implement recommendations<xref rid="R24" ref-type="bibr">24</xref> were perceived as key barriers.</p></sec><sec id="s3b2f"><title>Resource availability</title><p>Adequate human and material resources<xref rid="R19" ref-type="bibr">19 22</xref> and proper documentation<xref rid="R19" ref-type="bibr">19</xref> were reported as essentials to carry forward the NMCR.</p><p>On the other side, high patients workload, shortage of staff,<xref rid="R16" ref-type="bibr">16 17 19–22 24</xref> staff absenteeism<xref rid="R19" ref-type="bibr">19 20</xref> and/or high staff turnover,<xref rid="R21" ref-type="bibr">21</xref> together with shortage of equipment and supplies, including stationery,<xref rid="R16" ref-type="bibr">16 19 23</xref> insufficient record-keeping<xref rid="R17" ref-type="bibr">17 19</xref> and underestimation of resources needed<xref rid="R21" ref-type="bibr">21</xref> were all perceived as barriers, associated with low morale among staff and desire to leave work.<xref rid="R16" ref-type="bibr">16</xref></p></sec><sec id="s3b2g"><title>Culture and practice of quality improvement</title><p>A long list of sociocultural factors was reported as being either a facilitator or a barrier to effective implementation of NMCR. Factors perceived as facilitators were the following: a blame-free environment<xref rid="R19" ref-type="bibr">19</xref>; a culture of self-reflection among health workers and a general positive attitude towards audit and feedback<xref rid="R20" ref-type="bibr">20 22</xref>; being a teaching hospital associated with research,<xref rid="R17" ref-type="bibr">17</xref> motivational factors such as a desire to improve quality among healthcare personnel.<xref rid="R23" ref-type="bibr">23</xref> Finally, staff’s understanding that good quality in case management and appropriate documentation can help protect them in the case of a legal litigation<xref rid="R22" ref-type="bibr">22</xref> was also reported as a facilitator.</p><p>The list of sociocultural barriers included: a culture of blaming, fear and individual punishment<xref rid="R16" ref-type="bibr">16 19–22</xref>; lack of knowledge on the principles and methods of audits<xref rid="R17" ref-type="bibr">17 22</xref>; the fact that NMCRs were not perceived as being part of regular duties<xref rid="R17" ref-type="bibr">17 21</xref> or that they were perceived as a way of controlling staff<xref rid="R23" ref-type="bibr">23</xref>; lack of knowledge and/or interest in quality improvement<xref rid="R17" ref-type="bibr">17</xref>; and inadequate knowledge on principles, methods and contents of evidence-based medicine.<xref rid="R17" ref-type="bibr">17 19 22</xref> These factors were reported as being associated with difficulties from staff when questioned about their own work,<xref rid="R17" ref-type="bibr">17 19 23</xref> and an attitude of making up excuses and not withholding the truth about what actually happened during the care of near-miss cases.<xref rid="R19" ref-type="bibr">19 21</xref></p></sec><sec id="s3b2h"><title>Hierarchy, cultural norms among health staff and interpersonal relationships</title><p>Good practices of communication and cooperation between different cadres of health workers<xref rid="R19" ref-type="bibr">19 22</xref> and the possibility of challenging a higher-level staff<xref rid="R19" ref-type="bibr">19</xref> were reported as facilitators of the NMCR implementation.</p><p>On the other side, barriers were perceived as following: the existence of hierarchical differences<xref rid="R16" ref-type="bibr">16</xref>; nurses, midwives and doctors working separately as opposed to acting as part of a team<xref rid="R16" ref-type="bibr">16</xref>; doctors’ feeling/behaving as superior compared with other levels of staffing<xref rid="R16" ref-type="bibr">16 22</xref>; disrespectful manners towards lower-level staff<xref rid="R20" ref-type="bibr">20</xref>; lack of assertiveness among mid-level staff<xref rid="R17" ref-type="bibr">17 19 20</xref>; staff not being used to speak in public, fear of talking in presence of staff in a higher rank<xref rid="R17" ref-type="bibr">17 19</xref>; previously existing conflicts at interpersonal level<xref rid="R22" ref-type="bibr">22</xref> as well as lack of external support to facilitate these dynamics.<xref rid="R22" ref-type="bibr">22</xref></p></sec><sec id="s3b2i"><title>Attitude towards patients and medical conditions</title><p>The existence of a sufficient degree of empowerment among patients, patients having a recognised status and being respected,<xref rid="R16" ref-type="bibr">16</xref> together with a caring attitude from the staff<xref rid="R16" ref-type="bibr">16 17</xref> were reported as facilitators of the NMCR implementation.</p><p>On the other side, difficulty of accepting professional responsibility,<xref rid="R22" ref-type="bibr">22</xref> poor attention and low priority given to some clinical conditions possibly leading to complications (eg, obstructed labour),<xref rid="R16" ref-type="bibr">16</xref> together with a low commitment to serve/work<xref rid="R16" ref-type="bibr">16</xref> were reported as barriers.</p></sec><sec id="s3b2j"><title>Outputs and outcomes</title><p>Several studies reported that sustainability of audits also depended on their perceived effects. Where healthcare staff perceived that audits had a positive impact on quality of care—such as maternal or perinatal outcomes, respect for women’s rights during childbirth, availability of equipment and organisation of care—<xref rid="R21" ref-type="bibr">21</xref> and/or a positive impact on healthcare staff dynamics—such as improved communication and coordination, improved acceptance of responsibilities, increased awareness of problems, improved knowledge and skills<xref rid="R20" ref-type="bibr">20–22 24</xref> — these factors facilitated the NMCR implementation over time.</p><p>On the other side, a lack of evidence or clarity about what the NMCR was, and on its effectiveness<xref rid="R19" ref-type="bibr">19 22</xref> was perceived as a barrier to sustain the case reviews.</p></sec></sec><sec id="s3b3"><title>External partners factors</title><sec id="s3b3a"><title>Sustained support</title><p>The existence of an external body or organisation able to provide technical support, and if needed additional required resources<xref rid="R21" ref-type="bibr">21 22 24</xref> were reported as a key factor to ensure effective NMCR implementation in different settings.</p></sec><sec id="s3b3b"><title>Key recommendations</title><p><xref rid="T5" ref-type="table">Table 5</xref> synthesises key recommendations for effective NMCR implementation. Actions are divided in those that may be implemented in the short term and those needing a longer time for the implementation but that may result in a longer-term impact.</p><table-wrap id="T5" orientation="portrait" position="float"><label>Table 5</label><caption><p>Key recommendations for effective NMCR implementation</p></caption><table frame="hsides" rules="groups"><thead><tr><td valign="top" align="left" rowspan="1" colspan="1">Short term</td><td valign="top" align="left" rowspan="1" colspan="1">Long term</td></tr></thead><tbody><tr><td valign="top" align="left" rowspan="1" colspan="1"><bold>External partners</bold><list list-type="bullet"><list-item><p>Ensure technical support.</p></list-item></list></td><td valign="top" align="left" rowspan="1" colspan="1"><bold>External partners</bold><list list-type="bullet"><list-item><p>Ensure sustained technical support, in particular on the quality of the NMCR.</p></list-item></list></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"><bold>National level</bold><list list-type="bullet"><list-item><p>Ensure general commitment and understanding of national and local health authorities.</p></list-item><list-item><p>Ensure financial resources.</p></list-item><list-item><p>Make available updated evidenced-based national guidelines and standards.</p></list-item><list-item><p>Develop a good action plan and budget, covering all WHO recommendations.*</p></list-item><list-item><p>Create the legal framework.</p></list-item><list-item><p>Ensure effective leadership and coordination.</p></list-item><list-item><p>Ensure timely monitoring and evaluation.</p></list-item><list-item><p>Support timely transparent results dissemination to health staff and the community.</p></list-item><list-item><p>Promote local responsibility and ownership.</p></list-item><list-item><p>Collaborate with an external body for quality assessment.</p></list-item></list></td><td valign="top" align="left" rowspan="1" colspan="1"><bold>National level</bold><list list-type="bullet"><list-item><p>Integrate NMCR in a comprehensive quality improvement plan for maternal and newborn health.</p></list-item><list-item><p>Support continuous medical education.</p></list-item><list-item><p>Integrate key concepts of quality improvement methods, including audits, in medical and midwifery schools’ curricula.</p></list-item><list-item><p>Support and disseminate a culture that promotes health system changes, professionalism and team work.</p></list-item><list-item><p>Training in communication skills and team management.</p></list-item><list-item><p>Policies to ensure adequate resources (human resources, equipment and supplies) to health facilities.</p></list-item><list-item><p>Policies to improve quality of documentation.</p></list-item><list-item><p>Community empowerment and policies for including service users views in health planning.</p></list-item></list></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"><bold>Local level</bold><list list-type="bullet"><list-item><p>Ensure commitment, understanding and active participation of hospital directors.</p></list-item><list-item><p>Dissemination of updated evidenced-based national guidelines and standards.</p></list-item><list-item><p>Develop a good action plan and budget, covering all WHO recommendations,<xref rid="R5" ref-type="bibr">5</xref> considering feasibility based on local resources.</p></list-item><list-item><p>Inform and create awareness among all staff.</p></list-item><list-item><p>Train and adequate number and type of staff.</p></list-item><list-item><p>Consider ways to provide some form of professional recognition for health staff involved in NMCR.</p></list-item><list-item><p>Ensure effective leadership and coordination.</p></list-item><list-item><p>Ensure that NMCR sessions are carried forward according the WHO recommendations.<xref rid="R5" ref-type="bibr">5</xref></p></list-item><list-item><p>Ensure that recommendations from the NMCR are put in place.</p></list-item><list-item><p>Ensure timely transparent results dissemination to all staff.</p></list-item></list></td><td valign="top" align="left" rowspan="1" colspan="1"><bold>Local level</bold><list list-type="bullet"><list-item><p>Same activities as for national level, when appropriate to local level.</p></list-item></list></td></tr></tbody></table><table-wrap-foot><fn id="tblfn9"><p>*See the WHO manual: WHO. Regional Office for Europe. Conducting a maternal near-miss case review cycle at the hospital level’ manual with practical tools. Available at <ext-link ext-link-type="uri" xlink:href="http://www.euro.who.int/en/health-topics/Life-stages/maternal-and-newborn-health/publications/2016/conducting-a-maternal-near-miss-case-review-cycle-at-hospital-level-2016">http://www.euro.who.int/en/health-topics/Life-stages/maternal-and-newborn-health/publications/2016/conducting-a-maternal-near-miss-case-review-cycle-at-hospital-level-2016</ext-link></p></fn><fn id="tblfn10"><p>NMCR, near-miss case review.</p></fn></table-wrap-foot></table-wrap></sec></sec></sec></sec><sec sec-type="discussion" id="s4"><title>Discussion</title><p>This review fills a gap in evidence synthesis on facilitators and barriers to effective implementation of NMCR. Findings of the review suggest that the effective implementation of NMCR in maternity hospitals is a complex intervention that can be challenged by a number of barriers at different levels (national, facility, external partner level), including technical aspects (such as leadership and coordination mechanisms), resource availability (adequate human resources to manage workload and essential supplies), sociocultural factors (such as existing cultural norms, hierarchy among healthcare staff and patients’ empowerment) and the lack of external support. On the other side, a number of facilitating factors were identified. Findings from this systematic review suggest a list of practical recommendations (<xref rid="T5" ref-type="table">table 5</xref>), which can be used by policy-makers and managers to prevent and mitigate common challenges to successful NMCR implementation.</p><p>This review was conducted according to the PRISMA<xref rid="R8" ref-type="bibr">8</xref> and the ENTREQ<xref rid="R9" ref-type="bibr">9</xref> standards. A broad search strategy in a large number of electronic databases was used. The key limitation of the review is the paucity of existing relevant scientific reports: although the NMCR approach has been used in many countries, there has been relatively few formal studies exploring facilitators and barriers to effective NMCR implementation. Despite the above-described limitation, this review retrieved an appreciable number of good-quality studies from the African Region. Findings of the review are therefore mostly generalisable to this setting.</p><p>Outside the African Region, we retrieved several informal evaluations reporting on enablers and barriers to effective NMCR implementation in Europe, Central Asia, South East Asia, Latin America and the Caribbean.<xref rid="R25" ref-type="bibr">25–37</xref> It will be inappropriate to pull together results of peer-reviewed formal studies with those of unpublished technical reports and informal evaluations. However, it may be interesting to acknowledge that grey literature<xref rid="R25" ref-type="bibr">25–37</xref> suggests that key factors enabling effective NMCR implementation in countries other than the African Region are similar to those observed in this review, with some peculiarities specific to each context. First, the importance of good leadership is a recurrent theme highlighted virtually in all grey literature.<xref rid="R25" ref-type="bibr">25–37</xref> Second, the crucial role of a positive cultural environment has been reported as a key determinant of successful NMCR implementation on a global scale.<xref rid="R25" ref-type="bibr">25–36</xref> For example, a review of experiences of NMCR implementation supported by the International Federation for Gynecology and Obstetrics in Europe, Asia and Africa identified three independent cultural factors as key determinants for the successful NMCR implementation: (1) individual responsibility and ownership; (2) a proactive institutional ethos, promoting learning as a crucial part of improving services and (3) a supportive political and policy environment at both national and local levels.<xref rid="R25" ref-type="bibr">25</xref> On the other side, identified cultural barriers for performing NMCR included a culture of blaming, fear and individual punishment, together with a lack of professionalism.<xref rid="R25" ref-type="bibr">25</xref> Similarly, reports on NMCR implementation in ex-Soviet countries identified a culture of blaming, fear and individual punishment, and hierarchy among staff as key barriers for successful NMCR implementation.<xref rid="R28" ref-type="bibr">28–32</xref> In ex-Soviet countries, the key element in promoting a safe, friendly, confidential environment was the emanation from Ministry of Health of <italic>prikazes</italic> (national laws) and the commitment of hospital directors to a non-punitive system.<xref rid="R35" ref-type="bibr">35 36</xref></p><p>In line with what has been observed in this review, grey literature reporting experiences of NMCR implementation in LMIC in Europe and Asia deemed as crucial to provide some professional recognition for health staff involved in the case reviews.<xref rid="R25" ref-type="bibr">25 27 33</xref> In settings with very low resources, a small financial incentive was reported as essential, since in these contexts any non-paid activity outside working hours means a serious loss of income.<xref rid="R21" ref-type="bibr">21</xref> Again, similarly to what has been reported in studies included in this review,<xref rid="R19" ref-type="bibr">19</xref> the importance for staff to perceive clearly the potential and/or actual benefits of the audits (eg, improvements in quality of care, organisation of care, staff knowledge and recognition) was recognised as a key determinant of successful NMCR implementation in a number of reports from different regions,<xref rid="R37" ref-type="bibr">37</xref> while disillusion from lack of actions following the reviews was highlighted as a important barrier for NMCR sustainability.<xref rid="R25" ref-type="bibr">25–28</xref></p><p>Lack of knowledge of the evidence-based maternal and perinatal practices was reported as a barrier to NMCR implementation in the WHO European region,<xref rid="R29" ref-type="bibr">29</xref> as well in studies in this review. As far as different types of hospitals were concerned, reports from both Europe, Latin America and Africa observed that the implementation of NMCR was easier in lower level facilities<xref rid="R16" ref-type="bibr">16 24 33</xref> or research hospitals<xref rid="R17" ref-type="bibr">17</xref> where staff was used to work together, rather than in large maternity units dominated by ‘academic tradition’ difficult to challenge<xref rid="R33" ref-type="bibr">33</xref> or where there was high staff turnover.<xref rid="R16" ref-type="bibr">16</xref> Poor patient empowerment and insufficient inclusion of service user views were reported as barriers to successful NMCR implementation in Europe, Asia and Africa.<xref rid="R25" ref-type="bibr">25 27 33</xref> Finally, the availability of an external partner/organisation capable of providing sustained technical support (and, if needed, the resources to put in place the quality improvement recommendations) was a key factor mentioned in many reports from different countries.<xref rid="R25" ref-type="bibr">25 27–30 32 35 36</xref></p><p>This review contributes to the current debate on quality improvement interventions and on the knowledge of potential challenges to their implementation. When compared with other systematic reviews of facilitators and barriers of effective implementation of other quality improvement interventions,<xref rid="R38" ref-type="bibr">38 39</xref> it appears that, not surprising, many barriers, such as the lack of coordination and leadership or lack of knowledge of evidence-based practices, are common to different quality improvement interventions. More research should be conducted to test strategies aiming at facilitating successful implementation for NMCR as well as for other quality improvement interventions.</p></sec><sec sec-type="conclusions" id="s5"><title>Conclusions</title><p>Studies suggest that the effective implementation of NMCR at facility level is a complex intervention that can be challenged by a number of barriers at different levels (national, facility level, external partner level). Policy-makers, in planning the NMCR implementation, should consider the lessons learnt from previous studies as synthesised in this paper and should carefully plan actions to prevent and mitigate common challenges to successful NMCR implementation. Future studies should aim at documenting better facilitators and barriers to successful implementation of the facility-based individual NMCR, especially outside the African region, as well as exploring facilitators and barriers for other quality improvement interventions, and in testing strategies aiming at facilitating successful implementation.</p></sec><sec sec-type="supplementary-material"><title>Supplementary Material</title><supplementary-material id="d35e166" content-type="local-data"><caption><title>Reviewer comments</title></caption><media mimetype="application" mime-subtype="pdf" xlink:href="bmjopen-2017-021281.reviewer_comments.pdf"></media></supplementary-material><supplementary-material id="d35e167" content-type="local-data"><caption><title>Author's manuscript</title></caption><media mimetype="application" mime-subtype="pdf" xlink:href="bmjopen-2017-021281.draft_revisions.pdf"></media></supplementary-material></sec></body><back><ack><p>We thank Sonia Richardson for having reviewed the English language of this manuscript.</p></ack><fn-group><fn fn-type="other"><p><bold>Contributors:</bold> ML conceived the papers, extracted data, analysed data, drafted the first version of this paper and finalised the final version. SR screened the studies and revised the first draft. BC and MC extracted data, analysed data and revised the first draft.</p></fn><fn fn-type="other"><p><bold>Funding:</bold> This review was funded by a grant from the GREAT Network, Canadian Institutes of Health Research, St. Michael’s Hospital, Toronto.</p></fn><fn fn-type="COI-statement"><p><bold>Competing interests:</bold> None declared.</p></fn><fn fn-type="other"><p><bold>Patient consent:</bold> Not required.</p></fn><fn fn-type="other"><p><bold>Provenance and peer review:</bold> Not commissioned; externally peer reviewed.</p></fn><fn fn-type="other"><p><bold>Data sharing statement:</bold> All key data are provided in the paper. 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