<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="research-article" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">Gates Open Res</journal-id>
            <journal-title-group>
                <journal-title>Gates Open Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2572-4754</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/gatesopenres.13120.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Research Article</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Do quality improvement interventions for person-centered family planning work? Evidence from Kenya</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: 1 approved, 1 approved with reservations]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Diamond-Smith</surname>
                        <given-names>Nadia</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-8711-3029</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Giessler</surname>
                        <given-names>Katie</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Munson</surname>
                        <given-names>Meghan</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Green</surname>
                        <given-names>Cathy</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>Institute for Global Health Sciences, University of California, San Francisco, San Francisco, California, 94158, USA</aff>
                <aff id="a2">
                    <label>2</label>Jacaranda Health, Nairobi, Kenya</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:katie.giessler@ucsf.edu">katie.giessler@ucsf.edu</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>28</day>
                <month>4</month>
                <year>2020</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2020</year>
            </pub-date>
            <volume>4</volume>
            <elocation-id>44</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>9</day>
                    <month>4</month>
                    <year>2020</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2020 Diamond-Smith N et al.</copyright-statement>
                <copyright-year>2020</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://gatesopenresearch.org/articles/4-44/pdf"/>
            <abstract>
                <p>
                    <bold>Background:</bold> Quality of care for family planning, especially person-centered care, is important from a health and human-rights standpoint. Few interventions have aimed to improve person-centered family planning (PCFP) in low and middle-income countries. In this study, we tested the impact of a quality improvement (QI) intervention in Kenya on aspects of PCFP included in a validated measure of PCFP and on the overall PCFP scale.</p>
                <p>
                    <bold>Methods:</bold> We conducted QI cycles in three facilities providing family planning in Nairobi and Kiambu Counties, Kenya, with three facilities serving as controls. Cross-sectional baseline data was collected from 478 women receiving family planning in 2016 and end line data was collected from 640 in 2017-18.  We analysed the impact of the QI intervention on PCFP using difference-in-difference models.</p>
                <p>
                    <bold>Results:</bold> We found no impact of the QI intervention on either PCFP or the overall PCFP scale.</p>
                <p>
                    <bold>Conclusions:</bold> We take away key lessons learned from the null findings of the intervention that are important for future interventions. Lessons learned include the need to be flexible in light of external factors that prolonged the study and probably led to burnout; and simplifying measurement and procedures.</p>
                <p>
                    <bold>Abbreviations:</bold> PCC: Person-centered care; PCFP: Person-centered family planning; LMICs: Low-and middle-income countries; QI: Quality improvement; FP: Family planning; BTS: Breakthrough series; PDSA: Plan-Study-Do-Act</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Kenya</kwd>
                <kwd>family planning</kwd>
                <kwd>person-centered family planning</kwd>
                <kwd>PCFP</kwd>
                <kwd>quality improvement</kwd>
                <kwd>Quality Improvement Collaborative</kwd>
                <kwd>Breakthrough Series</kwd>
            </kwd-group>
            <funding-group>
                <award-group id="fund-1" xlink:href="http://dx.doi.org/10.13039/100000008">
                    <funding-source>David and Lucile Packard Foundation</funding-source>
                    <award-id>2015-62545</award-id>
                    <award-id>2017-66201</award-id>
                </award-group>
                <award-group id="fund-2" xlink:href="http://dx.doi.org/10.13039/100000865">
                    <funding-source>Gates Foundation</funding-source>
                    <award-id>OPP1127467</award-id>
                </award-group>
                <funding-statement>This study was funded with generous support from the Gates Foundation [OPP1127467] and the David and Lucile Packard Foundation [2015-62545, 2017-66201].</funding-statement>
                <funding-statement>
                    <italic>The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.</italic>
                </funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec sec-type="intro">
            <title>Introduction</title>
            <p>While there have been significant gains in contraceptive use in the past few decades, unmet need for family planning (FP) remains a significant challenge in Kenya, with 16.8% of women reporting an unmet need in 2017
                <sup>
                    <xref ref-type="bibr" rid="ref-1">1</xref>
                </sup>. Consequently, the Government of Kenya has been particularly interested in improving access to quality FP services, including a new urban program to integrate FP services into existing health services and working with health officials and community groups
                <sup>
                    <xref ref-type="bibr" rid="ref-2">2</xref>
                </sup>. Researchers have hypothesized that poor quality of FP services, including provider competence, interpersonal relationships, choice of methods, information given to clients, and appropriate constellation of services
                <sup>
                    <xref ref-type="bibr" rid="ref-3">3</xref>
                </sup>, may be a barrier to broader contraceptive use, particularly among lower socioeconomic status women
                <sup>
                    <xref ref-type="bibr" rid="ref-4">4</xref>,
                    <xref ref-type="bibr" rid="ref-5">5</xref>
                </sup>.</p>
            <p>Person-centered and woman-centered models of FP have been proposed as important strategies to improve the quality of FP services
                <sup>
                    <xref ref-type="bibr" rid="ref-3">3</xref>
                </sup>. These approaches for FP place the client at the center of care, working with broader health systems to ensure they receive dignified, respectful care, and that they are involved in all aspects of clinical decision-making
                <sup>
                    <xref ref-type="bibr" rid="ref-6">6</xref>,
                    <xref ref-type="bibr" rid="ref-7">7</xref>
                </sup>. This approach has been shown to improve client satisfaction
                <sup>
                    <xref ref-type="bibr" rid="ref-6">6</xref>,
                    <xref ref-type="bibr" rid="ref-8">8</xref>
                </sup> and method continuation
                <sup>
                    <xref ref-type="bibr" rid="ref-6">6</xref>
                </sup>.</p>
            <p>A recent review of the limited person-centered family planning (PCFP) interventions that do exist found that only two involved quality improvement (QI) approaches
                <sup>
                    <xref ref-type="bibr" rid="ref-9">9</xref>
                </sup>. Overall, interventions that targeted various forms of person-centered care (PCC) were generally successful at improving client perceptions of the quality of care (usually measured with a satisfaction question). Results were mixed for outcomes such as FP knowledge, uptake and continuation. With regard to the two QI interventions identified, the first focused solely on FP in Kenya and provided training for facilities on aspects of PCC as well as the facility environment
                <sup>
                    <xref ref-type="bibr" rid="ref-10">10</xref>
                </sup>. This intervention found impacts at the supervisory and provider levels and in observations of client-provider interactions; however, it did not find an impact on client reports of person-centered outcomes such as satisfaction, privacy, being treated well, confidentiality, and cleanliness of the facility. The second, in Malawi, focused on many aspects of maternal and reproductive health, including FP, and mostly measured more clinically related outcomes. Generally, the QI intervention did not impact outcomes for FP, however, respondents in the intervention group were more likely post intervention to say that the provider &#x201c;established a cordial relationship and identified her needs&#x201d;
                <sup>
                    <xref ref-type="bibr" rid="ref-11">11</xref>
                </sup>.</p>
            <p>QI methodologies have been implemented across various global healthcare settings to improve both processes and health outcomes. In 1995, the Institute for Health Improvement developed a QI framework called the &#x201c;Breakthrough Series&#x201d; (BTS) to support healthcare systems in making improvements while simultaneously reducing costs
                <sup>
                    <xref ref-type="bibr" rid="ref-12">12</xref>
                </sup>. A key aim of the BTS is collaborative learning, which is facilitated by bringing together multi-disciplinary QI teams to work on common challenges typically over 9&#x2013;12 months. Within a BTS or Improvement Collaborative, QI teams agree on collaborative and facility aims for improvement, share their performance using common measures and then work individually during quarterly &#x201c;action periods&#x201d;&#x201d; to secure improvements. After each action period, participants in the Collaborative meet together to discuss progress from the previous period, set aims for the upcoming action period and identify potential changes they could make to improve outcomes. Improvement Collaboratives use Plan-Study-Do-Act (PDSA) cycles to test and adapt change strategies aimed at improving the selected outcome
                <sup>
                    <xref ref-type="bibr" rid="ref-13">13</xref>
                </sup>. The BTS has been used to successfully secure improvements in maternal and child health in low-and middle-income countries (LMIC) settings and has been demonstrated to be cost-effective in resource-constrained environments
                <sup>
                    <xref ref-type="bibr" rid="ref-14">14</xref>,
                    <xref ref-type="bibr" rid="ref-15">15</xref>
                </sup>. We conducted an intervention using QI cycles to improve PCFP in three facilities in Nairobi and Kiambu Counties, Kenya, and explored the impact on PCFP related outcomes, compared to three comparison facilities., To our knowledge, this is the first application of the BTS to secure PCFP improvements in LMICs.</p>
        </sec>
        <sec sec-type="methods">
            <title>Methods</title>
            <sec>
                <title>Step 1: Baseline data collection</title>
                <p>First, six public health facilities providing family planning and delivery care were selected in Nairobi and Kiambu Counties, Kenya. Baseline data was collected from 478 women who had recently taken up a FP method from all facilities between August and September 2016. Data was collected to understand baseline PCC performance for FP clients so that we could inform the intervention and compare to endline data. Female research assistants surveyed women in a private location within the facility grounds for both baseline and endline for all six facilities, after the women completed a written informed consent. Interviews were conducted in the respondent&#x2019;s preferred language (English or Kiswahili or a mix of both) and took roughly 45 mins-1 hour. The survey (
                    <italic toggle="yes">Extended data</italic>
                    <sup>
                        <xref ref-type="bibr" rid="ref-16">16</xref>
                    </sup>) was read to respondents and data were entered into a tablet. Data was collected on women&#x2019;s experiences of receiving their family planning method, method choice and uptake, as well as socio-demographics.  The main outcome of interest is a validated scale for PCFP constructed by Sudhinaraset and colleagues
                    <sup>
                        <xref ref-type="bibr" rid="ref-7">7</xref>
                    </sup>. The validated PCFP scale for Kenya included 20 items, which fell into 2 sub-domains, &#x201c;autonomy, respectful care, and communication&#x201d; and &#x201c;health facility environment.&#x201d; The paper describing the validation process also describes the data collection approach in more detail
                    <sup>
                        <xref ref-type="bibr" rid="ref-7">7</xref>
                    </sup>.</p>
            </sec>
            <sec>
                <title>Step 2: QI Intervention development and implementation</title>
                <p>Three of these facilities were selected to participate in a QI intervention to improve PCC for FP clients and childbirth patients, while the remaining three were assigned to a control arm.  An Improvement Collaborative was then designed utilizing the BTS model
                    <sup>
                        <xref ref-type="bibr" rid="ref-12">12</xref>
                    </sup> and QI teams were formed at each intervention facility.  Initially, health facility managers were requested to nominate members from a range of staff disciplines suggested by the external QI expert (e.g. doctors, midwives, data clerks, support staff). Over time, QI team members recruited additional colleagues to cover gaps when pivotal staff were moved or greater representation was needed.</p>
                <p>Over the course of the 9-month Collaborative, the QI teams worked together to improve four specific PCC topics in FP. The QI intervention was implemented over an extended time period due to delays related to two national strikes of healthcare providers that occurred during the study period. The intervention began in June of 2017 and completed in October of 2018. Intervention facilities developed change ideas to improve performance on the following person-centered family planning care topics: 1) Health care providers introduce themselves to the client; 2) Healthcare providers call the client by her name; 3) Doctors and nurses asked the client how she was feeling; and 4) The client felt she could ask any questions that she had. Topics were chosen based on data from the baseline survey about gaps.  Intervention facilities focused on developing change ideas for a specific set of topics for three months, and focused on new topics in the subsequent quarter.</p>
            </sec>
            <sec>
                <title>Step 3: End line data collection</title>
                <p>An endline evaluation (
                    <italic toggle="yes">Extended data</italic>
                    <sup>
                        <xref ref-type="bibr" rid="ref-16">16</xref>
                    </sup>) of 640 women was conducted across all six study sites between October 2018 and April 2019 to assess intervention impact. The same recruitment and data collection approach was used as at baseline (described above).</p>
            </sec>
            <sec>
                <title>Data analysis</title>
                <p>We ran a series of difference-in-differences models on various outcomes related to PCC. Per standard practice, the difference-in-differences estimators included a variable for time (baseline/endline), a variable for intervention (intervention/control) and a multiplier of these two (time*intervention). The primary outcomes explored included looking at PCFP overall and the specific topics focused on in the QI intervention
                    <sup>
                        <xref ref-type="bibr" rid="ref-7">7</xref>
                    </sup>. A higher score on the PCFP scale indicated a more positive experience at the time of receiving family planning counselling and a method.</p>
                <p>We first compared the population in the control and intervention facilities using t-tests to see if any significant demographic differences emerged. We then explored the change in the mean PCFP score and sub-scales between baseline and endline, and between control and intervention facilities, using t-tests. Finally, we conducted a series of difference-in-differences models that looked at the impact of the intervention on the following: the full PCFP score, two subscales (&#x201c;autonomy, respectful care and communication&#x201d; and &#x201c;health facility environment&#x201d;) and the four specific topic areas that facilities focused on in the Improvement Collaborative. Not all facilities worked on all four &#x201c;improvement&#x201d; topics, therefore analysis of performance differences between baseline and endline for these four topics excluded non-participatory facilities. All data analysis was conducted in Stata version 15
                    <sup>
                        <xref ref-type="bibr" rid="ref-17">17</xref>
                    </sup>.</p>
            </sec>
            <sec>
                <title>Ethical approval</title>
                <p>This study (intervention and data collection) was approved by the Institutional Review Board at The University of California, San Francisco [# 15-18008] and the Kenya Medical Research Institute&#x2019;s Scientific and Ethics Review Unit {# Non-KEMRI 526}. All subjects have provided written consent to participate in study activities under these approvals.</p>
            </sec>
        </sec>
        <sec sec-type="results">
            <title>Results</title>
            <p>
                <xref ref-type="table" rid="T1">Table 1</xref> shows the demographics of respondents, broken down by those in intervention and control facilities. All in all there were 227 women in the control and 292 women in the intervention facilities at baseline, and 294 women in the control and 349 women in the intervention facilities at end line (no significance difference in sample size). Intervention and control facilities were significantly different in terms of age, with control facilities having more younger women. There were no significant differences between intervention and control participants in terms of marital status, work, parity, or education. Women in the intervention facilities were more likely to be of the dominant tribe (Kikuyu) than in control facilities. Most women (77.6%) adopted a long-term FP method, with no differences between intervention and controls. About a third (33.2%) of all women said they were very satisfied with their care, and most said that the provider had no preference, a slight preference, or a moderate preference about what method they adopted, again with no difference between control and intervention facilities (80.1%).</p>
            <table-wrap id="T1" orientation="portrait" position="anchor">
                <label>Table 1. </label>
                <caption>
                    <title>Comparison of demographics by control and intervention facilities.</title>
                </caption>
                <table content-type="article-table" frame="hsides">
                    <thead>
                        <tr>
                            <th colspan="1" rowspan="1"/>
                            <th align="left" colspan="2" rowspan="1" valign="top">Control</th>
                            <th align="left" colspan="2" rowspan="1" valign="top">Intervention</th>
                            <th align="left" colspan="2" rowspan="1" valign="top">Total</th>
                        </tr>
                        <tr>
                            <th colspan="1" rowspan="1"/>
                            <th align="left" colspan="1" rowspan="1" valign="top">No.</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">%</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">No.</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">%</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">No.</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">%</th>
                        </tr>
                    </thead>
                    <tbody>
                        <tr>
                            <td colspan="1" rowspan="1"/>
                            <td align="left" colspan="1" rowspan="1" valign="top">521</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">44.95</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">638</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">55.05</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">1159</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">100</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">

                                <bold>Age category</bold>
</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Under 20</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">19</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">3.6</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">10</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">1.6</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">29</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">2.5</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">20&#x2013;24</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">182</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">34.9</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">203</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">31.8</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">385</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">33.2</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">25&#x2013;29</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">163</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">31.3</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">230</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">36.1</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">393</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">33.9</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">30 and over</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">157</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">30.1</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">195</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">30.6</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">352</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">30.4</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="3" rowspan="1" valign="top">Pearson chi2(3) = 9.0756 Pr = 0.028</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="left" colspan="2" rowspan="1" valign="top">
                                <bold>Marital status</bold>
                            </td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Single, cohabiting, partnered, divorced, widowed</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">76</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">14.6</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">86</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">14.4</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">162</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">14.5</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Married</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">445</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">85.4</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">511</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">85.6</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">956</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">85.5</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="3" rowspan="1" valign="top">Pearson chi2(3) = 6.9537 Pr = 0.073</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="left" colspan="2" rowspan="1" valign="top">
                                <bold>Number of births</bold>
                            </td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">1</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">217</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">42.2</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">246</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">42.1</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">463</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">42.2</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">2</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">167</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">32.5</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">192</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">32.9</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">359</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">32.7</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">3</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">90</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">17.5</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">104</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">17.8</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">194</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">17.7</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">4+</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">40</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">7.8</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">42</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">7.2</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">82</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">7.5</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="3" rowspan="1" valign="top">Pearson chi2(3) = 0.1544 Pr = 0.985</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">
                                <bold>Working</bold>
                            </td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">No</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">246</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">47.2</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">273</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">45.7</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">519</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">46.4</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Yes</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">275</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">52.8</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">324</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">54.3</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">599</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">53.6</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="3" rowspan="1" valign="top">Pearson chi2(1) = 0.2477 Pr = 0.619</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">
                                <bold>Education</bold>
                            </td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">No school/Primary</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">177</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">34</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">219</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">36.7</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">396</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">35.4</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Post-primary/vocational/Secondary</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">215</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">41.3</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">235</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">39.4</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">450</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">40.3</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">College or above</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">129</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">24.8</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">143</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">24</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">272</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">24.3</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="3" rowspan="1" valign="top">Pearson chi2(2) = 0.9018 Pr = 0.637</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="left" colspan="2" rowspan="1" valign="top">
                                <bold>Religion</bold>
                            </td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Non- majority</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">226</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">43.4</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">246</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">41.2</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">472</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">42.2</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Majority Religion</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">295</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">56.6</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">351</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">58.8</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">646</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">57.8</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="3" rowspan="1" valign="top">Pearson chi2(1) = 0.5381 Pr = 0.463</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">
                                <bold>Tribe</bold>
                            </td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Other tribe</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">360</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">69.1</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">263</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">44.1</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">623</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">55.7</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Kikuyu</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">161</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">30.9</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">334</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">55.9</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">495</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">44.3</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="3" rowspan="1" valign="top">Pearson chi2(1) = 70.7258 Pr = 0.000</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="left" colspan="2" rowspan="1" valign="top">
                                <bold>Type of family planning adopted</bold>
                            </td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Short term (condom, pill)</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">106</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">20.5</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">144</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">24.1</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">250</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">22.4</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Long term (IUD, implant, injectable)</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">411</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">79.5</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">453</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">75.9</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">864</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">77.6</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="3" rowspan="1" valign="top">Pearson chi2(1) = 2.0833 Pr = 0.149</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="left" colspan="2" rowspan="1" valign="top">
                                <bold>Satisfied with care</bold>
                            </td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Satisfied, dissatisfied, very dissatisfied</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">357</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">68.5</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">390</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">65.3</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">747</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">66.8</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Very satisfied</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">164</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">31.5</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">207</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">34.7</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">371</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">33.2</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="3" rowspan="1" valign="top">Pearson chi2(1) = 1.2812 Pr = 0.258</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="left" colspan="2" rowspan="1" valign="top">
                                <bold>Provider preference for which method adopted</bold>
                            </td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">None, slight, moderate preference</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">420</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">80.6</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">475</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">79.6</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">895</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">80.1</td>
                        </tr>
                        <tr>
                            <td align="right" colspan="1" rowspan="1" valign="top">Strong, very strong preference</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">101</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">19.4</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">122</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">20.4</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">223</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">19.9</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="3" rowspan="1" valign="top">Pearson chi2(1) = 0.1920 Pr = 0.661</td>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                            <td colspan="1" rowspan="1"/>
                        </tr>
                    </tbody>
                </table>
            </table-wrap>
            <p>There was a significant improvement in PCFP scores in control facilities between baseline and endline, increasing from a mean of 41.70 to 43.20 (p=0.0245) (
                <xref ref-type="table" rid="T2">Table 2</xref>). There was no change in PCFP scores in intervention facilities over time.</p>
            <table-wrap id="T2" orientation="portrait" position="anchor">
                <label>Table 2. </label>
                <caption>
                    <title>Mean person-centered care scores over time by intervention and control facilities.</title>
                </caption>
                <table content-type="article-table" frame="hsides">
                    <thead>
                        <tr>
                            <th colspan="1" rowspan="1"/>
                            <th align="left" colspan="1" rowspan="1" valign="top">Baseline</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">Endline</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">T-test p-value</th>
                        </tr>
                    </thead>
                    <tbody>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">Control Facilities</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">41.70</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">43.20</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">0.0245</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">Intervention</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">42.95</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">42.97</td>
                            <td align="left" colspan="1" rowspan="1" valign="top">0.9772</td>
                        </tr>
                    </tbody>
                </table>
            </table-wrap>
            <p>Difference-in-difference models showed that there was no impact of the intervention on the total PCFP scores or the two sub-scales of the PCFP scale (
                <xref ref-type="table" rid="T3">Table 3</xref>). When looking at the specific item-focuses of the QI intervention (for example, facilities that specifically worked on the PCFP topic &#x201c;provider asking if the woman had any questions&#x201d; did not see a change in reports of that item), we found that there was a significant negative impact of the intervention on the &#x201c;providers calling respondents by their name&#x201d; item for the combined effects of the intervention and time, even though this indicator significantly improved both over time and in intervention compared to control facilities. The sub-domain for Health Facility Environment and the item for &#x201c;provider introducing themselves&#x201d; significantly increased between the two survey rounds as well. </p>
            <table-wrap id="T3" orientation="portrait" position="anchor">
                <label>Table 3. </label>
                <caption>
                    <title>Difference-in-difference (DID) models of the impact of the person centered care (PCC) intervention on PCC measures.</title>
                </caption>
                <table content-type="article-table" frame="hsides">
                    <thead>
                        <tr>
                            <th colspan="1" rowspan="1"/>
                            <th align="center" colspan="1" rowspan="1" valign="top">Survey round</th>
                            <th align="center" colspan="1" rowspan="1" valign="top">Intervention</th>
                            <th align="center" colspan="1" rowspan="1" valign="top">DID</th>
                        </tr>
                    </thead>
                    <tbody>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">Full PCC scale</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.953 (-0.381 - 2.288)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">2.551
                                <xref ref-type="other" rid="TFN1">*</xref> (-0.477 - 5.579)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">-1.385 (-3.214 - 0.444)</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">Autonomy, respectful care,
                                <break/>communication</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.393 (-0.719 - 1.506)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">1.799 (-0.723 - 4.322)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">-0.924 (-2.448 - 0.600)</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">Health facility and environment</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.456
                                <xref ref-type="other" rid="TFN1">**</xref> (0.0960 - 0.816)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.503 (-0.321 - 1.328)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">-0.301 (-0.797 - 0.195)</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">Provider introduced themself (all
                                <break/>facilities)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.149
                                <xref ref-type="other" rid="TFN1">**</xref> (0.0248 - 0.274)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">-0.0174 (-0.298 - 0.263)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.150
                                <xref ref-type="other" rid="TFN1">*</xref> (-0.0202 - 0.320)</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">Provider called the respondent
                                <break/>by name (all facilities)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.567
                                <xref ref-type="other" rid="TFN1">***</xref> (0.386 - 0.748)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.448
                                <xref ref-type="other" rid="TFN1">**</xref> (0.0275 - 0.868)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">-0.292
                                <xref ref-type="other" rid="TFN1">**</xref> (-0.543 - -0.0406)</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">Provider asked respondent how
                                <break/>she was feeling (2 facilities)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.0772 (-0.156 - 0.311)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">-0.0670 (-0.672 - 0.538)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.0638 (-0.296 - 0.424)</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="top">Provider asked respondent if she
                                <break/>had questions (1 facility)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.0315 (-0.181 - 0.244)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">0.398 (-0.301 - 1.097)</td>
                            <td align="center" colspan="1" rowspan="1" valign="top">-0.211 (-0.623 - 0.202)</td>
                        </tr>
                    </tbody>
                </table>
                <table-wrap-foot>
                    <fn id="TFN1">
                        <p>*All data presented controlling for age, marital status, education, working status, tribe, number of children and family planning method adopted</p>
                        <p>*** p&lt;0.01, ** p&lt;0.05, * p&lt;0.1</p>
                    </fn>
                </table-wrap-foot>
            </table-wrap>
        </sec>
        <sec sec-type="discussion">
            <title>Discussion</title>
            <p>This evaluation found no impact of the intervention on women&#x2019;s reports of the PCFP that they experienced. This held true for the full scale, sub-scales, and also individual items that each facility focused on in their QI work. Given the substantial body of evidence pointing toward Improvement Collaboratives as an effective intervention in low- and middle-income healthcare settings, the most likely interpretation of these results is that observed challenges hindered the QI intervention. Feedback we received from study facilities corroborates this interpretation. </p>
            <p>First, the QI process itself may have been too cumbersome to be effective. QI teams set out to improve more topics for this project than is typical in an Improvement Collaborative. Alongside the four topics for FP, another 13 were selected for maternity care. This was necessary to try and detect an impact in the overall evaluations (the PCFP and person-centered maternity care scales). However, it dramatically increased the amount of time required to organize and analyse data in weekly QI review meetings. In addition, QI teams faced an extra burden of gathering their own performance data. QI work characteristically utilizes data that is already recorded in registers or collated for performance management purposes. Person-centered care performance is rarely monitored routinely in healthcare facilities, thus QI teams were asked to conduct their own exit interviews to assess on-going progress. This required a disproportionate amount of team effort to maintain suggested sample sizes to understand changes in QI team performance.</p>
            <p>Delays due to two national strikes by doctors and nurses extended the overall project timeline from 9 to 21 months. This exacerbated the impact of staff turnover on QI team cohesion and continuity. The overall duration may have contributed to a decline in attendance at QI team meetings in the final three-months of the program and a sense of &#x201c;improvement fatigue&#x201d; reported by the expert QI facilitators.</p>
            <p>Second, system constraints within the healthcare facilities may also have hindered the QI intervention. External evaluators noted stock-outs of FP methods reported by intervention and control facilities alike during the endline data collection period. This experience is likely to have influenced overall levels of satisfaction with the FP services, as some clients may have been asked to choose an alternative FP method or return when new supplies were available. This failure is likely to have influenced overall perceptions of PCFP in both intervention and control facilities equally, however combined with challenges noted above could have had additional impact in intervention facilities.</p>
            <p>Disentangling potential contributors can help future interventions aimed to improve quality of FP services have better success, especially for person-centered measures or that use QI approaches. Future work to improve PCC in FP should ensure a streamlined QI process with a low burden on data collection and number of topics to improve.</p>
            <sec>
                <title>Limitations</title>
                <p>This study had a robust design with both control and intervention facilities being measured both pre and post-intervention. Despite this, there were also limitations. All respondents had selected a FP method; therefore, we were not able to measure the impact of the QI intervention on FP uptake. Additionally, our focus was only in Nairobi and Kiambu counties, which are urban and peri-urban, and thus these findings are not generalizable to other parts of Kenya or other settings.</p>
            </sec>
        </sec>
        <sec>
            <title>Ethics approval and consent to participate</title>
            <p>This study was approved by the Institutional Review Board at The University of California, San Francisco [# 15-18008] and the Kenya Medical Research Institute&#x2019;s Scientific and Ethics Review Unit {# Non-KEMRI 526}. All subjects have provided written consent to participate in study activities under these approvals.</p>
        </sec>
        <sec>
            <title>Data availability</title>
            <sec>
                <title>Underlying data</title>
                <p>Dryad: Evaluation of person centered quality improvement intervention for family planning in Kenya, 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.7272/Q6SX6BD9">https://doi.org/10.7272/Q6SX6BD9</ext-link>
                    <sup>
                        <xref ref-type="bibr" rid="ref-16">16</xref>
                    </sup>.</p>
                <p>This project contains the following underlying data:</p>
                <list list-type="bullet">
                    <list-item>
                        <label>- </label>
                        <p>Baseline data</p>
                    </list-item>
                    <list-item>
                        <label>- </label>
                        <p>Endline data</p>
                    </list-item>
                </list>
            </sec>
            <sec>
                <title>Extended data</title>
                <p>Dryad: Evaluation of person centered quality improvement intervention for family planning in Kenya, 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.7272/Q6SX6BD9">https://doi.org/10.7272/Q6SX6BD9</ext-link>
                    <sup>
                        <xref ref-type="bibr" rid="ref-16">16</xref>
                    </sup>.</p>
                <p>This project contains the following extended data:</p>
                <list list-type="bullet">
                    <list-item>
                        <label>- </label>
                        <p>Baseline survey</p>
                    </list-item>
                    <list-item>
                        <label>- </label>
                        <p>Endline survey</p>
                    </list-item>
                </list>
                <p>Data are available under the terms of the 
                    <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">Creative Commons Zero "No rights reserved" data waiver</ext-link> (CC0 1.0 Public domain dedication).</p>
            </sec>
        </sec>
    </body>
    <back>
        <ack>
            <title>Acknowledgements</title>
            <p>The authors would like to thank all members of the Quality Improvement teams and their respective facility leadership for their participation in the intervention and continued commitment to improve the quality of family planning services in Kenya. We additionally thank the Kiambu and Nairobi County governments, and the Kenya Ministry of Health for their assistance, guidance and support throughout the duration of the study. We would like to thank the team at Jacaranda Health for executing and implementing the intervention, as well as the data collection teams at Innovations for Poverty Action for their efforts in obtaining survey data. Finally, we thank the women who took the time to participate in our survey and whose contributions have shed light on the efficacy and viability of this intervention approach to improve family planning experiences. </p>
        </ack>
        <ref-list>
            <ref id="ref-1">
                <label>1</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Cahill</surname>
                            <given-names>N</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Sonneveldt</surname>
                            <given-names>E</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Stover</surname>
                            <given-names>J</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Modern contraceptive use, unmet need, and demand satisfied among women of reproductive age who are married or in a union in the focus countries of the Family Planning 2020 initiative: a systematic analysis using the Family Planning Estimation Tool.</article-title>
                    <source>

                        <italic toggle="yes">Lancet.</italic>
</source>
                    <year>2018</year>;<volume>391</volume>(<issue>10123</issue>):<fpage>870</fpage>&#x2013;<lpage>82</lpage>.
                    <pub-id pub-id-type="pmid">29217374</pub-id>
                    <pub-id pub-id-type="doi">10.1016/S0140-6736(17)33104-5</pub-id>
                    <pub-id pub-id-type="pmcid">5854461</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-2">
                <label>2</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Keyonzo</surname>
                            <given-names>N</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Nyachae</surname>
                            <given-names>P</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Kagwe</surname>
                            <given-names>P</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>From Project to Program: Tupange&#x2019;s Experience with Scaling Up Family Planning Interventions in Urban Kenya.</article-title>
                    <source>

                        <italic toggle="yes">Reprod Health Matters.</italic>
</source>
                    <year>2015</year>;<volume>23</volume>(<issue>45</issue>):<fpage>103</fpage>&#x2013;<lpage>13</lpage>.
                    <pub-id pub-id-type="pmid">26278838</pub-id>
                    <pub-id pub-id-type="doi">10.1016/j.rhm.2015.06.010</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-3">
                <label>3</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Bruce</surname>
                            <given-names>J</given-names>
                        </name>
</person-group>:
                    <article-title>Fundamental Elements of the Quality of Care: A Simple Framework.</article-title>
                    <source>

                        <italic toggle="yes">Stud Fam Plann.</italic>
</source>
                    <year>1990</year>;<volume>21</volume>(<issue>2</issue>):<fpage>61</fpage>&#x2013;<lpage>91</lpage>.
                    <pub-id pub-id-type="pmid">2191476</pub-id>
                    <pub-id pub-id-type="doi">10.2307/1966669</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-4">
                <label>4</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Simmons</surname>
                            <given-names>R</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Elias</surname>
                            <given-names>C</given-names>
                        </name>
</person-group>:
                    <article-title>The study of client-provider interactions: a review of methodological issues.</article-title>
                    <source>

                        <italic toggle="yes">Stud Fam Plann.</italic>
</source>
                    <year>1994</year>;<volume>25</volume>(<issue>1</issue>):<fpage>1</fpage>&#x2013;<lpage>17</lpage>.
                    <pub-id pub-id-type="pmid">8209391</pub-id>
                    <pub-id pub-id-type="doi">10.2307/2137985</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-5">
                <label>5</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Tumlinson</surname>
                            <given-names>K</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Pence</surname>
                            <given-names>BW</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Curtis</surname>
                            <given-names>SL</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Quality of care and contraceptive use in urban Kenya.</article-title>
                    <source>

                        <italic toggle="yes">Int Perspect Sex Reprod Health.</italic>
</source>
                    <year>2015</year>;<volume>41</volume>(<issue>2</issue>):<fpage>69</fpage>&#x2013;<lpage>79</lpage>.
                    <pub-id pub-id-type="pmid">26308259</pub-id>
                    <pub-id pub-id-type="doi">10.1363/4106915</pub-id>
                    <pub-id pub-id-type="pmcid">4548971</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-6">
                <label>6</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Abdel-Tawab</surname>
                            <given-names>N</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Roter</surname>
                            <given-names>D</given-names>
                        </name>
</person-group>:
                    <article-title>The relevance of client-centered communication to family planning settings in developing countries: lessons from the Egyptian experience.</article-title>
                    <source>

                        <italic toggle="yes">Soc Sci Med.</italic>
</source>
                    <year>2002</year>;<volume>54</volume>(<issue>9</issue>):<fpage>1357</fpage>&#x2013;<lpage>68</lpage>.
                    <pub-id pub-id-type="pmid">12058852</pub-id>
                    <pub-id pub-id-type="doi">10.1016/s0277-9536(01)00101-0</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-7">
                <label>7</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Sudhinaraset</surname>
                            <given-names>M</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Afulani</surname>
                            <given-names>PA</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Diamond-Smith</surname>
                            <given-names>N</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Development of a Person-Centered Family Planning Scale in India and Kenya.</article-title>
                    <source>

                        <italic toggle="yes">Stud Fam Plann.</italic>
</source>
                    <year>2018</year>;<volume>49</volume>(<issue>3</issue>):<fpage>237</fpage>&#x2013;<lpage>58</lpage>.
                    <pub-id pub-id-type="pmid">30069983</pub-id>
                    <pub-id pub-id-type="doi">10.1111/sifp.12069</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-8">
                <label>8</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Dehlendorf</surname>
                            <given-names>C</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Henderson</surname>
                            <given-names>JT</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Vittinghoff</surname>
                            <given-names>E</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Association of the quality of interpersonal care during family planning counseling with contraceptive use.</article-title>
                    <source>

                        <italic toggle="yes">Am J Obstet Gynecol.</italic>
</source>
                    <year>2016</year>;<volume>215</volume>(<issue>1</issue>):<fpage>78.e1</fpage>&#x2013;<lpage>9</lpage>.
                    <pub-id pub-id-type="pmid">26827879</pub-id>
                    <pub-id pub-id-type="doi">10.1016/j.ajog.2016.01.173</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-9">
                <label>9</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Diamond-Smith</surname>
                            <given-names>N</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Warnock</surname>
                            <given-names>R</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Sudhinaraset</surname>
                            <given-names>M</given-names>
                        </name>
</person-group>:
                    <article-title>Interventions to improve the person-centered quality of family planning services: a narrative review.</article-title>
                    <source>

                        <italic toggle="yes">Reprod Health.</italic>
</source>
                    <year>2018</year>;<volume>15</volume>(<issue>1</issue>):<fpage>144</fpage>.
                    <pub-id pub-id-type="pmid">30153846</pub-id>
                    <pub-id pub-id-type="doi">10.1186/s12978-018-0592-6</pub-id>
                    <pub-id pub-id-type="pmcid">6114885</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-10">
                <label>10</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Reynolds</surname>
                            <given-names>HW</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Toroitich-Ruto</surname>
                            <given-names>C</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Nasution</surname>
                            <given-names>M</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Effectiveness of training supervisors to improve reproductive health quality of care: a cluster-randomized trial in Kenya.</article-title>
                    <source>

                        <italic toggle="yes">Health Policy Plan.</italic>
</source>
                    <year>2008</year>;<volume>23</volume>(<issue>1</issue>):<fpage>56</fpage>&#x2013;<lpage>66</lpage>.
                    <pub-id pub-id-type="pmid">17942447</pub-id>
                    <pub-id pub-id-type="doi">10.1093/heapol/czm037</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-11">
                <label>11</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Rawlins</surname>
                            <given-names>BJ</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Kim</surname>
                            <given-names>Y-M</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Rozario</surname>
                            <given-names>AM</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Reproductive health services in Malawi: An evaluation of a quality improvement intervention.</article-title>
                    <source>

                        <italic toggle="yes">Midwifery.</italic>
</source>
                    <year>2013</year>;<volume>29</volume>(<issue>1</issue>):<fpage>53</fpage>&#x2013;<lpage>9</lpage>.
                    <pub-id pub-id-type="pmid">22079625</pub-id>
                    <pub-id pub-id-type="doi">10.1016/j.midw.2011.10.005</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-12">
                <label>12</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <collab>Institute for Healthcare Improvement Diabetes Spectrum</collab>
</person-group>:
                    <article-title>The Breakthrough Series: IHI&#x2019;s Collaborative Model for Achieving Breakthrough Improvement.</article-title>
                    <source>

                        <italic toggle="yes">Diabetes Spectrum.</italic>
</source>
                    <year>2004</year>;<volume>17</volume>(<issue>2</issue>):<fpage>97</fpage>&#x2013;<lpage>101</lpage>.
                    <pub-id pub-id-type="doi">10.2337/diaspect.17.2.97</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-13">
                <label>13</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Langley</surname>
                            <given-names>K</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Nolan</surname>
                            <given-names>K</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Nolan</surname>
                            <given-names>T</given-names>
                        </name>
</person-group>:
                    <article-title>The Improvement Guide: A Practical Approach to Enhancing Organisational Performance.</article-title>San Francisco: Jossey-Bass;<year>1996</year>.</mixed-citation>
            </ref>
            <ref id="ref-14">
                <label>14</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Singh</surname>
                            <given-names>K</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Speizer</surname>
                            <given-names>I</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Handa</surname>
                            <given-names>S</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Impact evaluation of a quality improvement intervention on maternal and child health outcomes in Northern Ghana: early assessment of a national scale-up project.</article-title>
                    <source>

                        <italic toggle="yes">Int J Qual Health Care.</italic>
</source>
                    <year>2013</year>;<volume>25</volume>(<issue>5</issue>):<fpage>477</fpage>&#x2013;<lpage>87</lpage>.
                    <pub-id pub-id-type="pmid">23925506</pub-id>
                    <pub-id pub-id-type="doi">10.1093/intqhc/mzt054</pub-id>
                    <pub-id pub-id-type="pmcid">3888142</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-15">
                <label>15</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Broughton</surname>
                            <given-names>E</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Saley</surname>
                            <given-names>Z</given-names>
                        </name>

                        <name name-style="western">
                            <surname>Boucar</surname>
                            <given-names>M</given-names>
                        </name>

                        <etal/>
</person-group>:
                    <article-title>Cost-effectiveness of a quality improvement collaborative for obstetric and newborn care in Niger.</article-title>
                    <source>

                        <italic toggle="yes">Int J Health Care Qual Assur.</italic>
</source>
                    <year>2013</year>;<volume>26</volume>(<issue>3</issue>):<fpage>250</fpage>&#x2013;<lpage>61</lpage>.
                    <pub-id pub-id-type="pmid">23729128</pub-id>
                    <pub-id pub-id-type="doi">10.1108/09526861311311436</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-16">
                <label>16</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Diamond-Smith</surname>
                            <given-names>N</given-names>
                        </name>
</person-group>:
                    <article-title>Evaluation of person centered quality improvement intervention for family planning in Kenya.</article-title>v5, UC San Francisco, Dataset,<year>2020</year>.
                    <ext-link ext-link-type="uri" xlink:href="http://www.doi.org/10.7272/Q6SX6BD9">http://www.doi.org/10.7272/Q6SX6BD9</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref-17">
                <label>17</label>
                <mixed-citation publication-type="journal">
                    <collab>StataCorp</collab>:
                    <article-title>Stata Statistical Software: Release 15.</article-title>College Station, TX: StataCorp LLC,<year>2017</year>.</mixed-citation>
            </ref>
        </ref-list>
    </back>
    <sub-article article-type="reviewer-report" id="report28803">
        <front-stub>
            <article-id pub-id-type="doi">10.21956/gatesopenres.14299.r28803</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Tumlinson</surname>
                        <given-names>Katherine</given-names>
                    </name>
                    <xref ref-type="aff" rid="r28803a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0001-8314-8219</uri>
                </contrib>
                <aff id="r28803a1">
                    <label>1</label>Department of Maternal and Child Health, Gillings School of Global Public Health, Carolina Population Center, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>26</day>
                <month>5</month>
                <year>2020</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2020 Tumlinson K</copyright-statement>
                <copyright-year>2020</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport28803" related-article-type="peer-reviewed-article" xlink:href="10.12688/gatesopenres.13120.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve-with-reservations</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>
                <bold>
                    <underline>Summary and overall recommendation:</underline>
                </bold>
            </p>
            <p> </p>
            <p> This is a very interesting and relevant article investigating the impact of a quality improvement strategy, known as the Breakthrough Series (BTS), on the quality of family planning service delivery in central Kenya. Although the authors found null results, the findings still offer important lessons in terms of intervention fidelity and feasibility in the Kenyan context. There are some key pieces of information missing and I urge the authors to fill these gaps to help their readership better understand and utilize these results in future quality improvement efforts. I provide additional details on these recommended changes below. I appreciate having the opportunity to review this manuscript and applaud the authors for their contribution to improving the quality of FP service delivery in LMICs.&#x00a0;</p>
            <p> </p>
            <p> 
                <bold>
                    <underline>Specific recommendations:</underline>
                </bold>
            </p>
            <p> </p>
            <p> 
                <underline>Title</underline>: I recommend changing the title to specify that the study took place in Nairobi/central Kenya. As written, readers may interpret the results as applicable to the country, as a whole.</p>
            <p> </p>
            <p> </p>
            <p> 
                <underline>Abstract:</underline> I would mention BTS specifically in the abstract.</p>
            <p> </p>
            <p> </p>
            <p> 
                <underline>Introduction</underline>: 
                <list list-type="order">
                    <list-item>
                        <p>
                            <underline>Recommend different source/evidence of Kenya&#x2019;s commitment to FP quality of care</underline>: The authors write: &#x201c;
                            <italic>Consequently, the Government of Kenya has been particularly interested in improving access to quality FP services, including a new urban program to integrate FP services into existing health services and working with health officials and community groups</italic>
                            <italic>2</italic>.&#x201d; The authors are referring to the Urban Reproductive Health Initiative in Kenya (known as Tupange, a Swahili word for &#x2018;let&#x2019;s plan&#x2019;), implemented from 2009-2014. I would be hesitant to call this program &#x2018;new.&#x2019; Additionally, it wasn&#x2019;t clear to me from the cited article that the national government has actually taken ownership and converted the Tupange project into a national program. Perhaps I skimmed the citation too quickly, but I think there is other/better evidence of the Kenyan government&#x2019;s commitment to high-quality family planning such as their participation in FP2020, etc.</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Complete Bruce framework</underline>: In citing the Bruce framework, don&#x2019;t forget &#x2018;follow-up mechanisms&#x2019; (and consider putting the elements of the framework in the same order as the Bruce article so that it&#x2019;s easier to see they are all there). Additionally, I might recommend calling &#x2018;interpersonal relationships&#x2019; something more explicit (as written, it&#x2019;s not clear that the relationship is between the provider and client.) Perhaps &#x201c;provider-client relations&#x201d; or &#x201c;interpersonal relations between providers and clients.&#x201d;</p>
                    </list-item>
                </list> 
                <underline>Methods</underline>: 
                <list list-type="order">
                    <list-item>
                        <p>
                            <underline>More information on facility and participant selection</underline>: Can the authors say more about how the six facilities were selected (randomly? Or was it convenience?) and the level of the facilities included (i.e. dispensary, health center, or hospital?). How was it determined which facilities would be intervention and which would be control? How many intervention facilities were in Nairobi versus Kaimbu? Can there also be more information about how FP clients were selected (all clients exiting on the day of the surveys? How many refused to participate?) and how they decided on the total number to interview at each site?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>More information on the range of the validated PCFP scale</underline>: Can the authors please describe the possible range of scores for the PCFP scale and the two sub-scales? Without this information, results are a little more difficult to interpret. What constitutes a meaningful change in scores?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>More information on the QI teams</underline>: How many providers participated in the original QI teams in each of the three intervention facilities? How many providers were replaced over time because they moved to a different facility? In other words, approximately how many people were members of the QI teams at each of the intervention facilities and how many people stayed on the team for the duration of the intervention, versus were replaced if they moved to a different facility?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>More description of how action areas were selected</underline>: Can you better describe how action areas were identified and prioritized? How did providers determine which items were likely to be most important to clients and therefore likely to impact their perception and use of services?</p>
                    </list-item>
                    <list-item>
                        <p>Health care versus Healthcare &#x2013; be consistent in spelling. Clarify that it&#x2019;s a repeated cross-section and not a longitudinal study following the same women at endline and baseline.</p>
                    </list-item>
                </list> 
                <underline>Results</underline>: 
                <list list-type="order">
                    <list-item>
                        <p>
                            <underline>Table 1, Title</underline>: A more descriptive title is needed. These are the demographics of FP clients, correct? And gathered at baseline, right?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Table 1, include facilities</underline>: Can you include facility characteristics (facility type, number of providers at each, etc)? How did these characteristics differ between the control and intervention facilities?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Table 1, Curious about categorization of covariates</underline>: Why is injectable categorized as a long-acting method? Why is &#x2018;satisfied&#x2019; grouped with &#x2018;dissatisfied&#x2019;?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Table 2, expanded</underline>: Can you expand the content of this table to include baseline/endline, treatment/control comparisons of the two PCFP sub-scales, in addition to the full scale PCFP scores?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Table 3, headings</underline>: Does survey round mean baseline versus endline and can this be clarified? Does intervention mean treatment versus control? Would be helpful to specify.</p>
                    </list-item>
                </list> 
                <underline>Discussion</underline>: 
                <list list-type="order">
                    <list-item>
                        <p>
                            <underline>Discuss differences between treatment and control groups</underline>: How might differences in age and tribe between control and treatment groups have impacted the results?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Providers and facility support staff conducted the exit interviews?</underline>&#x00a0;I stopped short on reading that the QI teams gathered much of the data themselves (including conducting exit interviews?); did I understand that correctly? Was this also true in the control sites? Were the providers all trained to do this? This seems highly burdensome to the providers and would likely impact their overall motivation and effort. Could this have impacted results? Apologies if I misunderstood. This seems a big deviation from the standard intervention protocol and would understandably reduce provider effort.</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Unpack discussion around impact of stock-outs</underline>: Build out the discussion more in terms of how stock-outs and other infrastructure/readiness deficits will significantly handicap and discourage providers attempting to offer a high standard of care. And, given the high prevalence of commodity stockouts, what does this suggest about the potential for success of future QI efforts? What infrastructure efforts might need to happen first?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Unpack discussion around provider turn-over and the feasibility of this type of intervention in Kenyan context</underline>: Build out the discussion much more about whether this type of intervention is really feasible in public facilities in Kenya where workers are frequently out due to strikes or transferred to other facilities. Is this the best approach in an environment with high provider turn-over?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Unpack discussion of null results</underline>: I encourage the authors to say more about how we should interpret the likelihood that the observed challenges impeded intervention fidelity as stockouts, strikes, and shifting workers are a consistent reality of the public healthcare system in Kenya. It is really striking that there was no impact on the four indicators &#x2013; didn&#x2019;t the providers at the intervention facilities identify and select these change areas themselves? Should this have led to buy-in and cooperation by the providers? And weren&#x2019;t these relatively low effort changes to implement? In other words &#x2013; I would have predicted that the treatment facilities would have seen a big jump in the four measures given they picked these measures themselves and they seem really easy to do. It&#x2019;s perplexing that 2 out of 3 intervention facilities didn&#x2019;t try to implement some of these change areas that they were involved in selecting. It would be helpful to better understand why this was the case as I imagine the participatory approach of BTS is a big part of why it typically works in other settings. Did you have feedback from the facility staff to help explain this? Why couldn&#x2019;t providers in two of the three facilities ask clients if they had any questions? This seems like such a simple thing to implement for a short period time, especially when you know you will be assessed on it. I&#x2019;m wondering if the facilities might have preferred to identify their own facility-specific indicators. Finally, could having only 1 or 2 facilities implementing some of the change areas have impacted the results?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Place findings in the context of existing literature</underline>: Can you add a small discussion in which you place your results in the context of the two PCFP QI studies described in the introduction?</p>
                    </list-item>
                    <list-item>
                        <p>
                            <underline>Could the intervention be adjusted to be more feasible</underline>? At a minimum, could the intervention be modified in future iterations to remove the burden of gathering performance data by the providers themselves &#x2013; it&#x2019;s easy to see how this would negatively impact providers with a high case load and a large amount of administrative tasks already &#x2013; which is the case for most large public-sector facilities in Kenya.</p>
                    </list-item>
                </list>
            </p>
            <p>Is the work clearly and accurately presented and does it cite the current literature?</p>
            <p>Yes</p>
            <p>If applicable, is the statistical analysis and its interpretation appropriate?</p>
            <p>Yes</p>
            <p>Are all the source data underlying the results available to ensure full reproducibility?</p>
            <p>Yes</p>
            <p>Is the study design appropriate and is the work technically sound?</p>
            <p>Yes</p>
            <p>Are the conclusions drawn adequately supported by the results?</p>
            <p>Yes</p>
            <p>Are sufficient details of methods and analysis provided to allow replication by others?</p>
            <p>Partly</p>
            <p>Reviewer Expertise:</p>
            <p>reproductive epidemiologist; social scientist in global population health</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.</p>
        </body>
    </sub-article>
    <sub-article article-type="reviewer-report" id="report28804">
        <front-stub>
            <article-id pub-id-type="doi">10.21956/gatesopenres.14299.r28804</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Abuya</surname>
                        <given-names>Timothy</given-names>
                    </name>
                    <xref ref-type="aff" rid="r28804a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0001-8815-8299</uri>
                </contrib>
                <aff id="r28804a1">
                    <label>1</label>Population Council, Nairobi, Kenya</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>18</day>
                <month>5</month>
                <year>2020</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2020 Abuya T</copyright-statement>
                <copyright-year>2020</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport28804" related-article-type="peer-reviewed-article" xlink:href="10.12688/gatesopenres.13120.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>General Comments</p>
            <p> The paper is generally well written and presented. However, there are a few details that would have made the paper better. I highlight a few of these areas below</p>
            <p> </p>
            <p> 1. Provide a few more details&#x00a0; of implementation 
                <list list-type="bullet">
                    <list-item>
                        <p>The paper would benefit if a summary of implementation process would be provide. This would have helped the reader appreciate the challenges they bring in the discussion. For example, what are the&#x00a0; areas the QI teams agreed to improve, how did this change over time, how did these areas relate to the measurement areas - ie to what extent did this fit the sub domains of the PCFP constructs&#x00a0;</p>
                    </list-item>
                </list> 2. Study design</p>
            <p> It would have better if some details are provided on how the assignment of facilities were done. This is a bit unclear. Two a few description of the facility characteristics to illustrate how similar they were ie. what level of facility are they? How did the facility environment score generated? This might give a clear understanding of context and provide a few details left out in study design &#x00a0;</p>
            <p> 3. Link between design and measurement elements&#x00a0; 
                <list list-type="bullet">
                    <list-item>
                        <p>It might be worth providing clarity on the measure constructs and the change ideas areas that facilities developed. A sort of map that links the constructs and the measurement areas might help appreciate the result better since it could be the change ideas did not necessary reflect all the elements of measurement. This together with the data on implementation process should be considered as supplementary&#x00a0;information&#x00a0;</p>
                    </list-item>
                </list> 4. Clarity on other minor issues</p>
            <p> Table 1 - Did the authors use - Satisfied, dissatisfied, very dissatisfied as one combined group? this was not clear to me.</p>
            <p> Similarly use of a combined marital status -&#x00a0;Single, cohabiting, partnered, divorced, widowed - was unclear as well. Was this due to small numbers? What was the logic?&#x00a0;</p>
            <p> </p>
            <p> 5 Discussion</p>
            <p> The authors have attempted to provide reasons behind&#x00a0; the lack of effect which to me makes sense. However, some details around intervention elements come in too late. An earlier description would help the reader follow it well.</p>
            <p>Is the work clearly and accurately presented and does it cite the current literature?</p>
            <p>Yes</p>
            <p>If applicable, is the statistical analysis and its interpretation appropriate?</p>
            <p>Yes</p>
            <p>Are all the source data underlying the results available to ensure full reproducibility?</p>
            <p>Yes</p>
            <p>Is the study design appropriate and is the work technically sound?</p>
            <p>Yes</p>
            <p>Are the conclusions drawn adequately supported by the results?</p>
            <p>Yes</p>
            <p>Are sufficient details of methods and analysis provided to allow replication by others?</p>
            <p>Yes</p>
            <p>Reviewer Expertise:</p>
            <p>Public health polices/evaluation, health system</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.</p>
        </body>
    </sub-article>
</article>
