<?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.14591.2</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>Using responsive feedback from routine monitoring data to guide course corrections for a family planning intervention in Nigeria</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 2; peer review: 2 approved]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Meekers</surname>
                        <given-names>Dominique</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/">Methodology</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/0000-0002-7281-3217</uri>
                    <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>Olutola</surname>
                        <given-names>Olaniyi</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-8154-934X</uri>
                    <xref ref-type="aff" rid="a2">2</xref>
                    <xref ref-type="aff" rid="a3">3</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Abu Turk</surname>
                        <given-names>Lynn</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0009-0003-8476-7574</uri>
                    <xref ref-type="aff" rid="a4">4</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>Department of International Health and Sustainable Development, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, 70112, USA</aff>
                <aff id="a2">
                    <label>2</label>DKT International, Lagos, Nigeria</aff>
                <aff id="a3">
                    <label>3</label>Department of Epidemiology and Medical Statistics, University of Ibadan, Ibadan, Oyo, Nigeria</aff>
                <aff id="a4">
                    <label>4</label>Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, 70112, USA</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:dmeekers@tulane.edu">dmeekers@tulane.edu</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>DM and OO are funded through BMGF investment INV-019286, which also funded the radio jingle campaign that is being evaluated.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>16</day>
                <month>11</month>
                <year>2023</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2023</year>
            </pub-date>
            <volume>7</volume>
            <elocation-id>75</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>14</day>
                    <month>11</month>
                    <year>2023</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 Meekers D et al.</copyright-statement>
                <copyright-year>2023</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/7-75/pdf"/>
            <abstract>
                <sec>
                    <title>Background</title>
                    <p>This paper aims to promote the use of simple interrupted time series (ITS) analyses of routine data as a responsive feedback tool to improve public health programs. Although advanced ITS  techniques exist, their use is often not feasible  due to limitations in funding or research capacity. We propose an Excel-based analysis that requires minimal resources or statistical expertise, and illustrate it by measuring the effect of a radio campaign to promote a family planning call center in Nigeria on the demand for family planning information.</p>
                </sec>
                <sec>
                    <title>Methods</title>
                    <p>We used a single group interrupted time series design (ITS) as a responsive feedback mechanism to determine whether the radio campaign influenced use of the Honey&amp;Banana call center. ITS is ideal when there is no control group. ITS uses the pre-intervention trend to predict what would have happened if the intervention were absent.</p>
                </sec>
                <sec>
                    <title>Results</title>
                    <p>After conducting ITS analyses, the results show that the number of calls requesting family planning information increased throughout the campaign period, with a gain of about 500 additional calls per month, and then decreased after the campaign ended. However, the number of calls gained from the campaign was substantially lower than anticipated.</p>
                </sec>
                <sec>
                    <title>Conclusions</title>
                    <p>While end-of-project impact evaluations are necessary, there should be regular feedback system to provide program implementers with information about the status of the project, such as failures, successes, and areas of improvements. This would allow implementers to make necessary adjustments as needed throughout the intervention period. The finding that the radio campaign was not living up to expectations helped Honey&amp;Banana program implementers to end the campaign prematurely and re-allocate resources to a more promising activity. Our research shows that basic Excel-based ITS analysis of routine data can be a useful tool for receiving regular feedback to guide programming improvements for organizations that have limited resources and/or research capacity.</p>
                </sec>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>responsive feedback</kwd>
                <kwd>family planning</kwd>
                <kwd>routine data</kwd>
                <kwd>interrupted time series</kwd>
                <kwd>mass media</kwd>
            </kwd-group>
            <funding-group>
                <award-group id="fund-1">
                    <funding-source>Gates Foundation</funding-source>
                    <award-id>INV-019286</award-id>
                </award-group>
                <funding-statement>This work was supported by the Gates Foundation [INV-019286].</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>
        <notes>
            <sec sec-type="version-changes">
                <label>Revised</label>
                <title>Amendments from Version 1</title>
                <p>This revised version of the manuscript acknowledges that more advanced ITS techniques are available, and clarifies that proposed technique is intended for instances when the use of such advanced techniques is not feasible, as may be the case for organizations that have limited resources and/or research capacity. The discussion section has been expanded to clarify that it would be recommended to apply the technique for all relevant and available outcomes measures, and that --data permitting-- it may be helpful to conduct separate analyses for key target subgroups.</p>
            </sec>
        </notes>
    </front>
    <body>
        <sec sec-type="intro">
            <title>Introduction</title>
            <p>There is growing recognition that many public health programs&#x2014;as well as broader development initiatives&#x2014;have been using a rigid one-size-fits-all implementation approach, despite the fact that they are dealing with very complex issues, often in rapidly changing circumstances (
                <xref ref-type="bibr" rid="ref-29">Harvard Kennedy School, 2014</xref>; 
                <xref ref-type="bibr" rid="ref-25">Viswanath 
                    <italic toggle="yes">et al.</italic>, 2019</xref>). Program implementers typically decide whether to continue or scale up their current approach based on the findings from end-of-project impact evaluations. Although end-of-project evaluations are invaluable for improving the design of future interventions, by definition they are conducted too late to benefit ongoing programs. Even when mid-project impact evaluations are conducted, by the time the results are available, limited time may be left to make course corrections.</p>
            <p>To address this issue, scholars and donors alike are increasingly advocating for incorporating responsive feedback mechanisms, sometimes called feedback loops, into the design of public health programs. For example, the Bill and Melinda Gates Foundation has sponsored 
                <italic toggle="yes">The Curve</italic>, a global community of practice that aims to help programs become more skilled at using responsive feedback to achieve better results (
                <ext-link ext-link-type="uri" xlink:href="https://the-curve.org/">https://the-curve.org</ext-link>), and the journal 
                <italic toggle="yes">Global Health: Policy and Practice</italic> is devoting a special issue to the subject. Responsive feedback mechanisms aim to &#x201c;&#x2026;allow intervention information to flow back to the program implementers on an ongoing basis so that appropriate changes in intervention delivery strategy can be adopted throughout the implementation period&#x201d; (
                <xref ref-type="bibr" rid="ref-20">Pant 
                    <italic toggle="yes">et al.</italic>, 2023</xref>). As such, responsive feedback serves an important learning function, based on successes as well as failures. Rapid cycles of project planning, obtaining responsive feedback, pause and reflection, and revisions (including replacing activities that do not perform as well as anticipated with more promising ones), are used to drive continuous program improvement (
                <xref ref-type="bibr" rid="ref-29">Harvard Kennedy School, 2014</xref>; 
                <xref ref-type="bibr" rid="ref-25">Viswanath 
                    <italic toggle="yes">et al.</italic>, 2019</xref>).</p>
            <p>A cursory review of projects that applied responsive feedback (
                <xref ref-type="bibr" rid="ref-1">Aisiri, 2019</xref>; 
                <xref ref-type="bibr" rid="ref-2">Ajijola 
                    <italic toggle="yes">et al.,</italic> 2023</xref>; 
                <xref ref-type="bibr" rid="ref-8">Ejeh 
                    <italic toggle="yes">et al.</italic>, 2021</xref>; 
                <xref ref-type="bibr" rid="ref-18">Onwuasor 
                    <italic toggle="yes">et al.</italic>, 2022</xref>) shows that a wide range of data collection techniques can be used (
                <italic toggle="yes">e.g.,</italic> social media feedback, rapid assessment phone surveys, self-administered survey tools, call-in radio programs, exit interviews at facilities, focus group discussions). The commonality between these techniques for obtaining feedback is that all of them allow frequent data collection. Indeed, frequent data collection is essential for facilitating regular cycles of evidence-based programmatic course corrections. Because many public health programs collect routine monitoring data on a monthly or quarterly basis, they can be an invaluable tool for incorporating responsive feedback into program implementation and revision.</p>
            <p>The aim of this paper is to advocate for the use of simple interrupted time series analyses of routine monitoring data as a responsive feedback tool for continuous program improvement, particularly in instances when the use of more sophisticated techniques is not feasible (e.g, due to lack of funding or limited research capacity). We illustrate the approach by examining the effect of a radio campaign to promote a family planning call center in Nigeria on the demand for family planning information and discuss how the findings were used to adjust the program activities.</p>
            <sec>
                <title>Intervention</title>
                <p>Honey&amp;Banana (H&amp;B) is a program dedicated to provide family planning information and services, which involves pregnancy prevention, child spacing and family size limitation. It is implemented by DKT International Nigeria (DKT). To receive confidential family planning advice, individuals are encouraged to use the program&#x2019;s website, social media pages, or its toll-free call center. H&amp;B focuses primarily on modern, long-acting reversible contraceptive methods (LARC). The call center can be reached by calling 55059; all call center agents have been trained to provide confidential information about family planning and ways to access it. If a caller intends to use a family planning method, the agent will refer them to a local family planning clinic from DKT&#x2019;s network of partner clinics. The call center offers family planning information in five different languages: English, Hausa, Igbo, Yoruba, and Pidgin English.</p>
                <p>To promote the call center, H&amp;B developed a large-scale radio jingle campaign that aimed to increase the number of callers requesting family planning information. Because 19% of currently married women and 48% of unmarried sexually active women have an unmet need for family planning (
                    <xref ref-type="bibr" rid="ref-16">National Population Commission (NPC) and ICF International, 2019</xref>), the latent demand for family planning information is believed to be high. The campaign was diffused on 28 radio stations throughout 12 states (Abia, Abuja FCT, Delta, Edo, Kano, Lagos, Nasarawa, Niger, Ogun, Oyo, Rivers, Sokoto). These states were chosen because of the presence of numerous partner clinics that would be able to handle the anticipated increase in demand for family planning services. The campaign was done by using seven different jingles that encouraged individuals to contact the call center for family planning information or to request a referral to a family planning provider. As such, the jingles aimed to address the latent demand for family planning information (rather than to provide family planning information or education). Given the size of the campaign, a large increase in the volume of calls was anticipated. It was also hoped that awareness of the call center would subsequently spread further through word of mouth.</p>
                <p>The radio jingles were broadcast in English, Pidgin, or Hausa, depending on the location, starting in December 2021. The original plan was for the campaign to run for six months, starting in December 2021. However, based on monthly feedback on the number of requests for family planning information received by the call center, the implementers decided to end the campaign in March 2022.</p>
            </sec>
        </sec>
        <sec sec-type="methods">
            <title>Methods</title>
            <sec>
                <title>Study design</title>
                <p>This paper applies a single group interrupted time series design as a responsive feedback mechanism for assessing whether the 
                    <italic toggle="yes">Honey&amp;Banana</italic> radio campaign helped increase use of the call center. Interrupted time series studies have been used to measure the effect of a wide range of public health policies and programs (
                    <xref ref-type="bibr" rid="ref-6">Booth 
                        <italic toggle="yes">et al.</italic>, 2018</xref>; 
                    <xref ref-type="bibr" rid="ref-7">Cheng 
                        <italic toggle="yes">et al.</italic>, 2016</xref>; 
                    <xref ref-type="bibr" rid="ref-9">Fuseini 
                        <italic toggle="yes">et al.</italic>, 2022</xref>; 
                    <xref ref-type="bibr" rid="ref-10">Hategeka 
                        <italic toggle="yes">et al.</italic>, 2020</xref>; 
                    <xref ref-type="bibr" rid="ref-12">Hudson 
                        <italic toggle="yes">et al.</italic>, 2019</xref>; 
                    <xref ref-type="bibr" rid="ref-13">Humphreys 
                        <italic toggle="yes">et al.</italic>, 2017</xref>; 
                    <xref ref-type="bibr" rid="ref-15">Ma 
                        <italic toggle="yes">et al.</italic>, 2020</xref>; 
                    <xref ref-type="bibr" rid="ref-19">Owuor &amp; Amolo 2019</xref>; 
                    <xref ref-type="bibr" rid="ref-23">Ramsay 
                        <italic toggle="yes">et al.</italic>, 2003</xref>; 
                    <xref ref-type="bibr" rid="ref-24">Turner 
                        <italic toggle="yes">et al.</italic>, 2020</xref>). However, they are typically used as an end-of-intervention impact evaluation (
                    <xref ref-type="bibr" rid="ref-4">Bernal 
                        <italic toggle="yes">et al.</italic>, 2019</xref>), rather than a responsive feedback mechanism.</p>
                <p>The most basic form of the ITS design simply examines the overall trend in a key outcome measure. This design is typically used when no control group is available. When the outcome measure is graphed over time, an interruption of the trend is expected to occur after the start of the intervention. This interruption may entail a change in the level of the outcome measure, a change in the rate at which the outcome had been improving, or both (
                    <xref ref-type="bibr" rid="ref-3">Bernal 
                        <italic toggle="yes">et al.</italic>, 2017</xref>). The ITS design then uses the pre-intervention trend in the desired health outcome to predict what likely would have happened in absence of the intervention. In other words, the counterfactual is based on the assumption that the pre-intervention trend would have continued. Comparison of the actual and projected trends gives an estimate of the impact of the intervention. Because this can be done for successive time intervals (
                    <italic toggle="yes">e.g.</italic> every month or quarter), implementers get continuous feedback about the effectiveness of their intervention.</p>
                <p>To use interrupted time series analyses of routine monitoring data as a responsive feedback mechanism, the intervention activity needs to have a clearly defined starting point. Many family planning programs implement social or mass media campaigns (
                    <italic toggle="yes">e.g.</italic> to encourage contraceptive use) that fit this requirement. Because several pre- and post-intervention data points are needed for the analysis, routine monitoring data (
                    <italic toggle="yes">e.g.,</italic> the monthly number of family planning clients or the number of contraceptives distributed) that are collected at fixed intervals are an ideal data source.</p>
                <p>Our study uses monitoring data on the monthly number of calls received during the pre-campaign period (January to November 2021) to calculate 1) the linear trend in the number of calls, and 2) the logarithmic trend. For simplicity, we estimated the pre-intervention trend with the &#x201c;trend line&#x201d; option in 
                    <ext-link ext-link-type="uri" xlink:href="https://www.microsoft.com/en-us/microsoft-365/excel">Microsoft Excel 365</ext-link>. Although more advanced modeling programs are available, Excel has been used in other studies (see 
                    <xref ref-type="bibr" rid="ref-24">
                        <italic toggle="yes">Turner et al.</italic> (2020)</xref>) and has the advantage that the approach can easily be replicated by programs that have limited internal research capacity.</p>
                <p>The linear trend assumes there is a steady increase in the number of calls received. The logarithmic trend assumes that the number of calls initially increases fairly rapidly, but then levels off. It has been noted that it is important to consider whether a linear model is appropriate, as certain outcomes may hit a natural ceiling (
                    <xref ref-type="bibr" rid="ref-14">Jandoc 
                        <italic toggle="yes">et al.</italic>, 2015</xref>). Since other sources of family planning information exist, the number of people who are interested in using the call center may eventually hit a ceiling. Hence, in the long term the logarithmic trend may be more realistic. We opted to model both the linear and logarithmic trends and used the relevant equations to project the expected number of calls in absence of the radio campaign. The formulas for the linear and logarithmic equations were used to calculate the projected number of calls for the months from December 2021 through May 2022.</p>
                <p>Time series data can be affected by autocorrelation, for example when data points that are close together tend to be more similar than those further apart. Autocorrelation in the pre-intervention data could affect the estimation of the trends that are used to generate the post-intervention counterfactual. Although we have no theoretical reason to suspect the presence of autocorrelation in the pre-intervention data, we heeded the recommendation to test for autocorrelation (
                    <xref ref-type="bibr" rid="ref-22">Raadt, 2018</xref>). We used 
                    <ext-link ext-link-type="uri" xlink:href="https://www.r-project.org/">R Project</ext-link> software (version 4.2.2) to conduct the Durbin-Watson autocorrelation test. The values of the Durbin-Watson test range from 0 to 4, a value of 2.0 indicating that no autocorrelation is detected. The results of the test confirmed that there is little or no autocorrelation in our pre-intervention data (DW=1.9421; p=0.3112).</p>
                <p>For our study, we anticipated that there would not be any substantial lag between the start of the radio jingles and the desired increase in the number of incoming calls requesting family planning information (
                    <xref ref-type="bibr" rid="ref-3">Bernal 
                        <italic toggle="yes">et al.</italic>, 2017</xref>). A lag is unlikely to occur because the radio campaign provides potential callers with an immediate solution for their unmet need for family planning information and because they are most likely to contact the call center while the call center short code is fresh in their memory. Hence, we anticipate observing an increase in the number of calls received, as soon as the campaign started in December 2021. For each of the estimation models (linear and logarithmic ITS), we estimated the effect of the radio campaign by calculating the difference between the actual and projected number of calls received for the period from December 2021 through May 2022.</p>
                <p>As the exposure to the radio campaign was not randomized, it is important to acknowledge that other factors, such as different program activities, may have influenced the use of the call center. These variables could possibly lead us to misinterpret how well the radio campaign was working. Since projected trend assumes the pre-intervention trend will continue, it is important to ensure that the pre-intervention trend &#x2013; including any outliers &#x2013; is well understood. Prior to the intervention, H&amp;B carried out two brief campaigns which could have increased use of the call center. Between April 1 to May 30, 2021, H&amp;B launched a campaign to encourage use of Sayana Press injectable contraceptives, reaching out to existing users to remind them of their next injection date, and sending an SMS blast to previous users who had not received an injection for over three months. In August 2021, H&amp;B conducted several promotional activities in celebration of the third anniversary of the call center, including intensified activities in affiliated family planning clinics, digital and social media platforms, and a small e-voucher campaign. From February 14 through March 31, 2022, DKT also conducted an HIV self-testing campaign during which self-test kits were distributed to post-secondary students in 29 states. Although this campaign did not focus on family planning, students were advised to contact the 
                    <italic toggle="yes">Honey&amp;Banana Connect</italic> call center with any questions or concerns, which may have increased the volume of calls during the radio jingle campaign.</p>
                <p>Through the H&amp;B website, DKT's contraceptive products, H&amp;B's social media pages, and the radio campaign, the call center toll-free number is being widely promoted. However, the H&amp;B website was offline from January to November 2021 due to a major attack and was subsequently redesigned. While the restored website was launched at the same time as the radio campaign, it mainly focuses on providing information about contraceptive products. The homepage displays the call center logo and phone number but primarily provides details about the different contraceptive products available, with links to request information about nearby certified family planning clinics and an online store. The toll-free number is also printed on the packaging of most DKT contraceptive brands, such as Fiesta condoms. Regular daily social media posts on Facebook and Instagram also list the toll-free number throughout the study period. As none of these channels were specifically focused on the period from December 2021 to March 2022, it is unlikely that they significantly influenced the results.</p>
                <p>There are other potential factors that may have affected the results, such as family planning programs implemented by the Nigerian public sector and other non-governmental organizations. The Society for Family Health and PSI Nigeria are two examples of non-governmental social marketing organizations that work across the country and deliver access to subsidized family planning products and promote their use. The Nigerian Urban Reproductive Health Initiative, implemented by Johns Hopkins Center for Communication Programs, also aims to increase contraceptive use in specific states including Lagos, Kaduna and Oyo. These programs may have affected the increase in demand for family planning information and services, but we are not aware of any programs that were implemented during the diffusion of the radio campaign (December 2021&#x2013;March 2022). These organizations' communication activities aim to address the demand for family planning information, so they are unlikely to confound our analysis.</p>
            </sec>
            <sec>
                <title>Data source</title>
                <p>The data source for this responsive feedback study consists of public records on the number of incoming calls received by the Honey &amp; Banana Connect call center, as published by DKT International Nigeria (
                    <xref ref-type="bibr" rid="ref-17">Olutola 
                        <italic toggle="yes">et al.</italic>, 2023</xref>). The database excludes calls that were not related to family planning (
                    <italic toggle="yes">e.g.,</italic> wrong number, crank calls, or calls not related to family planning). DKT generated the database based on customer records about all incoming calls received by the call center, which are entered using Customer Relations Management (CRM) software. The number of family planning related calls was extracted from the CRM customer records and aggregated by calendar month for inclusion in the database. Our outcome indicator is the monthly number of incoming calls that were related to family planning. Our study analyzes call center records of the 12,490 incoming calls received by the call center during the period from January 1, 2021 through May 31, 2022. Although using a longer post-intervention period is preferable when there are no known confounding factors (such as other campaigns), this was not feasible due to the start of an  H&amp;B e-voucher campaign in June 2022.</p>
                <p>The Tulane University Human Research Projection Office determined that this study is not human subjects research as define by the Common Federal Rule and does not require IRB review and approval (Ref #2023-590).</p>
            </sec>
            <sec>
                <title>Study limitations</title>
                <p>One of the main limitations of our study, which it shares with all ITS studies, is that it relies on an artificially constructed counterfactual that may not accurately represent what truly would have happened in absence of the intervention. Therefore, the accuracy of the estimated magnitude of the intervention impact depends heavily on the assumption that the pre-intervention trends would have continued. Outliers in the pre-intervention trends, like the ones that were observed in our example, can affect the accuracy of the projected trend. The two outliers in our example resulted from small interventions conducted by H&amp;B itself and that are typical H&amp;B activities. Hence, it is reasonable to assume that the pre-intervention trend would continue. Nevertheless, use of a single group ITS design with routine monitoring data can be a valuable approach to receive responsive feedback about a new intervention is working, even if the exact magnitude of the intervention effect is uncertain.</p>
                <p>Another limitation of the ITS design is it cannot easily be used when there are other competing campaigns. Due to the launch of a large-scale e-voucher campaign, we only have two data points after the radio campaign ended, which limited our ability to assess any longer-term effects of the campaign.</p>
            </sec>
        </sec>
        <sec sec-type="results">
            <title>Results</title>
            <sec>
                <title>Trend in requests for family planning information</title>
                <p>A number of authors recommend visually inspecting pre-intervention trends for instability and potential outliers prior to ITS analysis (
                    <xref ref-type="bibr" rid="ref-5">Biglan 
                        <italic toggle="yes">et al.</italic>, 2000</xref>; 
                    <xref ref-type="bibr" rid="ref-14">Jandoc 
                        <italic toggle="yes">et al.</italic>, 2015</xref>). High variability in the pre-intervention time series makes it harder to detect an intervention effect. Outliers may indicate that the ITS assumption that the pre-intervention trend would have continued in absence of the intervention is not valid. Some authors therefore re-analyze the data with the outliers removed (
                    <xref ref-type="bibr" rid="ref-12">Hudson 
                        <italic toggle="yes">et al.</italic>, 2019</xref>).</p>
                <p>
                    <xref ref-type="fig" rid="f1">Figure 1</xref> shows the observed trend in the number of calls requesting family planning information received by the call center, with the intervention period shaded in green. During the pre-campaign period (from January through November 2021) the monthly number of calls hovered roughly between 400 and 550, except for two notable outliers. The first outlier is the peak in April&#x2013;May (827 and 721 calls, respectively), which coincides with the period when the program conducted a campaign to promote the use of Sayana Press injectable contraceptives (
                    <xref ref-type="bibr" rid="ref-11">Honey&amp;BananaConnect, 2022</xref>). The second outlier is the peak of 842 calls in August, which coincides with the third anniversary of the call center. As part of the anniversary celebrations, the program intensified social media promotions of the call center, and implemented a small e-voucher campaign for free contraceptives (
                    <xref ref-type="bibr" rid="ref-40">DKT International Nigeria, 2021</xref>). The anniversary also was also noted in the press, which may have further increased awareness of the call center (
                    <xref ref-type="bibr" rid="ref-30">Brand Spur Media and Marketing Services, 2021</xref>; 
                    <xref ref-type="bibr" rid="ref-31">News Wings, 2021</xref>). Apart from these two temporary peaks, the monthly number of requests for family planning information showed fairly little variation during the pre-campaign period, and increased only minimally.</p>
                <fig fig-type="figure" id="f1" orientation="portrait" position="float">
                    <label>Figure 1. </label>
                    <caption>
                        <title>Number of requests for family planning information received.</title>
                        <p>Note: Shaded area depicts the duration of the radio campaign.</p>
                    </caption>
                    <graphic orientation="portrait" position="float" xlink:href="https://gatesopenresearch-files.f1000.com/manuscripts/16468/9172b225-0348-4694-917a-ae42865f8f06_figure1.gif"/>
                </fig>
                <p>Following the start of the radio campaign in December, the number of calls requesting family planning information nearly doubled, from 554 in November to 1,064 in December. It stayed at roughly this level through February (995 calls), and further increased to 1,471 in March. This latter increase may have resulted from the HIV self-testing campaign that was conducted at post-secondary institutions. Recipients of the self-test kits were advised to contact the 
                    <italic toggle="yes">Honey&amp;Banana Connect</italic> call center with questions or concerns, which may have increased the volume of calls. By April, when the radio campaign had ended, the number of requests for family planning information decreased, but remained substantially above the pre-campaign levels (852 calls in April; 961 in May).</p>
            </sec>
            <sec>
                <title>Single group interrupted time series (ITS) results</title>
                <p>Although the trend shown in 
                    <xref ref-type="fig" rid="f1">Figure 1</xref> clearly indicates that the radio campaign had an effect on use of the call center, it would be helpful to have an estimate of how big that effect was in terms of the net number of callers gained. To measure the impact of the radio campaign, we need to estimate how many requests for family planning information the call center would have received in absence of the campaign. Single group ITS assumes that without the campaign, the pre-intervention trend would have continued. We estimated both the linear trend (which assumes a steady increase) and the logarithmic trend (which assumes a rapid increase, followed by a leveling off).</p>
                <p>Based on the pre-intervention observed data, the linear trend was estimated as 
                    <italic toggle="yes">y</italic> = 2.8273
                    <italic toggle="yes">x</italic> + 544.13 and the logarithmic trend as 
                    <italic toggle="yes">y</italic> = 46.002 ln&#x2061;(
                    <italic toggle="yes">x</italic>) + 487.9, where 
                    <italic toggle="yes">y</italic> is the number of family planning related calls and 
                    <italic toggle="yes">x</italic> the time period (in months). Due to the random fluctuation and the two outliers, neither trend explained the variability in the number of calls.
                    <sup>
                        <xref ref-type="other" rid="FN1">1</xref>
                    </sup> After the start of the radio campaign, the level of the trend was notably higher, while the gradient was slightly negative (linear trend: 
                    <italic toggle="yes">y</italic> = &#x2013;11.657
                    <italic toggle="yes">x</italic> + 1093.8; logarithmic trend: 
                    <italic toggle="yes">y</italic> = &#x2013;12.14 ln&#x2061;(
                    <italic toggle="yes">x</italic>) + 1066.3).</p>
                <p>
                    <xref ref-type="fig" rid="f2">Figure 2</xref> shows the actual trend in the number of calls received during the entire study period, as well as the projected trend in absence of the radio campaign for the period from December 2021 through May 2022. The green line assumes that the trend is linear; the light blue line assumes that the trend is logarithmic. Consistent with our earlier observation that the monthly number of calls during the pre-campaign period was nearly constant (with the exception of the two peaks), both projections suggest that there would only have been a minimal increase in the number of requests for family planning information. Based on the linear projection, it is estimated that in absence of the radio campaign the monthly number of calls would have gradually increased from 554 in November (actual) to 592 in May. Based on the logarithmic projection, the increase would have been from 554 to 618.</p>
                <fig fig-type="figure" id="f2" orientation="portrait" position="float">
                    <label>Figure 2. </label>
                    <caption>
                        <title>Actual and projected number of requests for family planning information.</title>
                        <p>Note: Shaded area depicts the duration of the radio campaign.</p>
                    </caption>
                    <graphic orientation="portrait" position="float" xlink:href="https://gatesopenresearch-files.f1000.com/manuscripts/16468/9172b225-0348-4694-917a-ae42865f8f06_figure2.gif"/>
                </fig>
                <p>Visual comparison of the projected and actual number of requests suggests that the radio campaign generated 400&#x2013;800 additional information requests per month, for the duration of the campaign (December through March). Moreover, the data for April and May suggest that once the campaign had ended, the number of information requests remained considerably above the pre-campaign levels.</p>
            </sec>
            <sec>
                <title>Estimation of the campaign effect size</title>
                <p>The difference between the actual number of calls received and the projected numbers is our estimate of the effect of the radio campaign on the number of callers requesting family planning information. 
                    <xref ref-type="table" rid="T1">Table 1</xref> shows the actual number of calls received, the predicted number of calls using our two types of counterfactuals (ITS with linear and logarithmic projections), and the estimated number of calls gained for each model.</p>
                <table-wrap id="T1" orientation="portrait" position="anchor">
                    <label>Table 1. </label>
                    <caption>
                        <title>Estimated number of family planning calls gained by the radio campaign (December 2021&#x2013;May 2022).</title>
                    </caption>
                    <table content-type="article-table" frame="hsides">
                        <thead>
                            <tr>
                                <th align="center" colspan="1" rowspan="1" valign="top"/>
                                <th align="right" colspan="1" rowspan="1" valign="top">Observed
                                    <break/> number of calls</th>
                                <th align="center" colspan="2" rowspan="1" valign="top">Predicted
                                    <break/>number of calls</th>
                                <th align="right" colspan="2" rowspan="1" valign="top">Estimated effect
                                    <break/>(gain)</th>
                            </tr>
                            <tr>
                                <th align="center" colspan="1" rowspan="1" valign="top"/>
                                <th align="right" colspan="1" rowspan="1" valign="top">Total</th>
                                <th align="right" colspan="1" rowspan="1" valign="top">Linear projection
                                    <break/>(ITS)</th>
                                <th align="right" colspan="1" rowspan="1" valign="top">Logarithmic projection
                                    <break/>(ITS)</th>
                                <th align="right" colspan="1" rowspan="1" valign="top">Linear projection
                                    <break/>(ITS)</th>
                                <th align="right" colspan="1" rowspan="1" valign="top">Logarithmic
                                    <break/>projection (ITS)</th>
                            </tr>
                        </thead>
                        <tbody>
                            <tr>
                                <td align="right" colspan="1" rowspan="1" valign="top">12/21</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">1064</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">578</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">602</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">486</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">462</td>
                            </tr>
                            <tr>
                                <td align="right" colspan="1" rowspan="1" valign="top">01/22</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">975</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">581</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">606</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">394</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">369</td>
                            </tr>
                            <tr>
                                <td align="right" colspan="1" rowspan="1" valign="top">02/22</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">995</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">584</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">609</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">411</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">386</td>
                            </tr>
                            <tr>
                                <td align="right" colspan="1" rowspan="1" valign="top">03/22</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">1471</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">587</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">612</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">884</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">859</td>
                            </tr>
                            <tr>
                                <td align="right" colspan="1" rowspan="1" valign="top">04/22</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">852</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">589</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">615</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">263</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">237</td>
                            </tr>
                            <tr>
                                <td align="right" colspan="1" rowspan="1" valign="top">05/22</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">961</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">592</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">618</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">369</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">343</td>
                            </tr>
                            <tr>
                                <td align="right" colspan="1" rowspan="1" valign="top">Total</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">6318</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">3511</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">3664</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">2807</td>
                                <td align="right" colspan="1" rowspan="1" valign="top">2654</td>
                            </tr>
                        </tbody>
                    </table>
                    <table-wrap-foot>
                        <fn>
                            <p>Note: ITS Interrupted time series.</p>
                        </fn>
                    </table-wrap-foot>
                </table-wrap>
                <p>For the period from December 2021 through May 2022, the linear projection model estimates that there were 2,807 additional calls requesting family planning information, while the logarithmic projection puts the gain at 2,654 calls. While the true effect size of the radio campaign remains unknown, our analyses suggest it is likely be in the range of 2,600&#x2013;2,800 additional requests for family planning information. To put that estimate in context, it implies that the radio campaign added the equivalent of the total number of requests for family planning information the call center would normally receive over a four to five month period. However, most of the gains occurred during the months while the radio campaign was active. As soon as the campaign ended, the gain in calls dropped to only 250&#x2013;350 calls per month. In other words, the feedback data indicate that the radio campaign only led to a temporary increase in demand for family planning information.</p>
            </sec>
        </sec>
        <sec sec-type="discussion">
            <title>Discussion</title>
            <p>Conventionally, public health programs&#x2013;including family planning programs&#x2013;have often used a fairly rigid intervention strategy. Decisions about the approach and intervention activities to use are typically made during the proposal development and/or design stage, and the agreed upon strategy is then implemented for the duration of the grant cycle, which may range from three to five years. End-of-project impact evaluations are then used to assess the extent to which the strategy was effective, and the lessons learned are incorporated into the design of follow-on programs. While end-of-project evaluations are necessary, the lengthy gap between such evaluations implies that the learning process is slow. Hence, there has been a push for programs to incorporate mechanisms that regularly provide feedback to program implementers about implementation problems, successes, and failures, so that appropriate programmatic adjustments can be made (
                <xref ref-type="bibr" rid="ref-29">Harvard Kennedy School, 2014</xref>; 
                <xref ref-type="bibr" rid="ref-25">Viswanath 
                    <italic toggle="yes">et al.</italic>, 2019</xref>). These feedback mechanisms also allow implementers to engage in short cycles of testing new activities, reflecting on lessons learned, and making programmatic adjustments, including discontinuing activities that do not live up to promise. As such, responsive feedback mechanisms go beyond traditional program monitoring, and can be considered to be a form of simple, continuous impact evaluations for program improvement.</p>
            <p>The responsive feedback approach is based on the premises 1) that making regular course corrections in response to changing field circumstances will make programs more effective, and 2) that course corrections should be informed by regular feedback about what is and is not working as intended. Since most programs engage in routine data collection, it would be beneficial to explore whether more thorough analyses of those data can serve as a responsive feedback mechanism to inform program adjustments.</p>
            <p>This study used analyzed routine data on the number of calls received by the Honey&amp;Banana Connect call center in Nigeria to get regular feedback about the effectiveness of a radio jingle campaign for increasing the demand for family planning information. Effectiveness of the campaign was measured using a simple interrupted time series design, without a control group. The first phase of the ITS analysis consists of a simple review of the graphed results (
                <xref ref-type="bibr" rid="ref-14">Jandoc 
                    <italic toggle="yes">et al.</italic>, 2015</xref>; 
                <xref ref-type="bibr" rid="ref-21">Penfold &amp; Zhang, 2013</xref>; 
                <xref ref-type="bibr" rid="ref-26">Wagner 
                    <italic toggle="yes">et al.</italic>, 2002</xref>), which Honey&amp;Banana was already doing as part of their program monitoring activities. Because the graphed results are easy to interpret, this already made it clear that the radio program triggered an increase in the number of calls received. The second phase of the ITS analysis consists of the creation of an artificial control group by projecting the pre-campaign trends in the number of calls received, which then enables quantification of the estimated number of calls that were added each month due to the radio campaign. Having an estimate of the number of new clients that were generated can be valuable for programs, because it helps clarify whether an intervention is performing up to expectations. In some cases, estimates of the number of new clients may also facilitate decision-making about staffing needs. It can also be valuable for reporting purposes in cases when grant proposals made explicit commitments about the number of new clients that would be generated.</p>
            <p>Our results indicated that the radio campaign was generating only about 500 additional requests for family planning information per month, which was well below the number that H&amp;B had hoped for, given the size and expense of the radio campaign. Because this feedback showed that the campaign was not living up to expectations, H&amp;B made an informed decision to end the radio campaign prematurely. Because routine data collection continued after the campaign was ended, the ITS analysis also showed that the effect of the radio campaign was largely temporary. By using responsive feedback, H&amp;B was able to shift resources to a different intervention activity that appeared more promising. Because small-scale campaigns offering e-vouchers for free contraceptive supplies had received a good response, H&amp;B shifted resources freed up from the radio campaign toward the development of scaled-up e-voucher campaign. H&amp;B  will use the same analytical approach to obtain regular feedback on the effectiveness of this new e-voucher, reflect on the findings, and to make decisions about potential program adjustments.</p>
            <p>Our study demonstrates that simple ITS analyses of routine data can be an invaluable tool for obtaining responsive feedback to inform programmatic adjustments. Basic ITS analyses&#x2013;as illustrated here&#x2013;can be conducted using only Excel spreadsheet software, and do not require extensive in-house research capacity. There are a number of simple ways to replicate the proposed approach to get more detailed programmatic information. Although our illustrative example only used one outcome measure (the number of calls received), it would be recommended to apply the same approach to all available outcome measures. For example, had the radio campaign resulted a drastic increase in the number of incoming calls, then the next step would be to use similar ITS analyses to access whether it also increased the number of callers who requested a referral to a family planning provider. Similarly, subject to data availability, it could be used to assess whether the radio intervention resulted in an increase in the number of clients who visited a network provider. Comparison of these findings would provide a simple way to assess to what extent an increase in the number of calls received by the call center translated into an increased number of referrals, and in turn into an increased number of family planning clients. If routine data exist for different population subgroups, the analysis can easily be replicated for each subgroup. For example, if data were collected on the number of male and female callers, or on the number of rural and urban callers, ITS analyses by subgroup could give additional insights about which subgroups were most responsive to the campaign.</p>
            <p>The ITS design is particularly suitable for decision-making about social and mass media campaigns, as these typically have a clear starting date. Because many organizations already collect routine program data, using ITS analyses of routine data as a responsive feedback tool may be feasible without incurring additional data collection costs. Assuming data for relevant outcome measures are available, the design can be useful when the pre-intervention trend is well understood and when there are no known competing interventions during the study period. Hence, we recommend that public health organizations explore whether they can use ITS analyses of routine data as a responsive feedback mechanism for continuous program improvement.</p>
        </sec>
        <sec>
            <title>Consent</title>
            <p>This study does not contain human subject data. The Tulane University Human Research Projection Office determined this study does not require IRB review and approval (Ref #2023-590)</p>
        </sec>
    </body>
    <back>
        <sec sec-type="data-availability">
            <title>Data availability</title>
            <p>Harvard Dataverse: Monthly number of phone calls received by the Honey&amp;Banana Connect family planning call center in Nigeria (January 2021 &#x2013; December 2022). 
                <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.7910/DVN/OMVLLB">https://doi.org/10.7910/DVN/OMVLLB</ext-link> (
                <xref ref-type="bibr" rid="ref-17">Olutola 
                    <italic toggle="yes">et al.</italic>, 2023</xref>).</p>
            <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>
        <ack>
            <title>Acknowledgments</title>
            <p>This research was conducted as part of the Honey&amp;Banana Connect project, which is implemented by DKT Nigeria. The authors are grateful to Mrs. Vivian Obozekhai, program manager of the Honey&amp;Banana program at DKT Nigeria, for her feedback and comments.</p>
        </ack>
        <fn-group>
            <fn id="FN1">
                <p>
                    <sup>1</sup> Based on the earlier observation that the pre-intervention included two outliers, we also calculated the pre-intervention trends both with and without the outliers. Both analyses produced similar results (not shown), but the omission of the outliers notably lowered the level of the trends. Although exclusion of the outliers improved the fit of trends, we have opted to only use the data that include the outliers because the small intervention activities that produced them are a more accurate representation of what would happen in absence of the radio campaign.</p>
            </fn>
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    <sub-article article-type="reviewer-report" id="report35508">
        <front-stub>
            <article-id pub-id-type="doi">10.21956/gatesopenres.16468.r35508</article-id>
            <title-group>
                <article-title>Reviewer response for version 2</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Mohan</surname>
                        <given-names>Diwakar</given-names>
                    </name>
                    <xref ref-type="aff" rid="r35508a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-7532-366X</uri>
                </contrib>
                <aff id="r35508a1">
                    <label>1</label>Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, 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>27</day>
                <month>1</month>
                <year>2024</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2024 Mohan D</copyright-statement>
                <copyright-year>2024</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="relatedArticleReport35508" related-article-type="peer-reviewed-article" xlink:href="10.12688/gatesopenres.14591.2"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>The comments raised have been addressed by the authors.</p>
            <p>Is the work clearly and accurately presented and does it cite the current literature?</p>
            <p>Partly</p>
            <p>If applicable, is the statistical analysis and its interpretation appropriate?</p>
            <p>Partly</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>Partly</p>
            <p>Are the conclusions drawn adequately supported by the results?</p>
            <p>Partly</p>
            <p>Are sufficient details of methods and analysis provided to allow replication by others?</p>
            <p>Partly</p>
            <p>Reviewer Expertise:</p>
            <p>quantitative research methods</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>
    <sub-article article-type="reviewer-report" id="report35112">
        <front-stub>
            <article-id pub-id-type="doi">10.21956/gatesopenres.15907.r35112</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Mohan</surname>
                        <given-names>Diwakar</given-names>
                    </name>
                    <xref ref-type="aff" rid="r35112a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-7532-366X</uri>
                </contrib>
                <aff id="r35112a1">
                    <label>1</label>Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, 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>27</day>
                <month>10</month>
                <year>2023</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 Mohan D</copyright-statement>
                <copyright-year>2023</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="relatedArticleReport35112" related-article-type="peer-reviewed-article" xlink:href="10.12688/gatesopenres.14591.1"/>
            <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>The manuscript is well written, free of errors and does not need English language editing.</p>
            <p> </p>
            <p> I would like to focus my feedback on 2 broad areas.</p>
            <p> </p>
            <p> 
                <bold>1. Need and relevance of ITS for monitoring:</bold> 
                <list list-type="bullet">
                    <list-item>
                        <p>a. Monitoring requires near live (relatively) time data collection and analysis - timely and flexible enough to allow for programmatic changes. This has been covered as part of the statistical methods designed for quality improvement studies in health care and has extensive literature backing it up. The authors have not made a clear case for the advantage of the ITS methodology over these pre-existing methods.</p>
                        <p> &#x00a0; 
                            <list list-type="bullet">
                                <list-item>
                                    <p>Brady 
                                        <italic>et al.</italic> (2018
                                        <sup>
                                            <xref ref-type="bibr" rid="rep-ref-35112-1">1</xref>
                                        </sup>).</p>
                                </list-item>
                                <list-item>
                                    <p>McQuillan 
                                        <italic>et al.</italic> (2016
                                        <sup>
                                            <xref ref-type="bibr" rid="rep-ref-35112-2">2</xref>
                                        </sup>).</p>
                                </list-item>
                            </list> </p>
                    </list-item>
                    <list-item>
                        <p>b. By the time one has enough sufficient data points to have a reasonable inference, it may be too late for course corrections. While in this present instance, the impact (referrals to and use of FP) may be logically implied from the output (number of calls), this may not always be the case in all instances. For example, the quality rather than the quantity of the output may be important. To use the present scenario as an example, if the conversion rate of the calls does not keep to a minimum the increase in calls is nothing more than a cost without the resultant benefit of FP use. Those monitoring the calls may be lulled into a misplaced sense of complacency by looking at the number of calls alone.</p>
                    </list-item>
                    <list-item>
                        <p>c. Accounting for lag &#x2013; While the present example allowed for no lag due to its nature, this may not be the usual case in most other interventions/programs. When the effect is insidious and can take more time than the time points used for the data, the effects may be difficult to separate/assess or too late.</p>
                    </list-item>
                    <list-item>
                        <p>d. Nature of the outcome &#x2013; While a continuous numerical outcome provides the maximum efficiency for detection of changes, it may not always be possible to rely on one being available and relevant. Offsets could account for the &#x2018;denominator&#x2019; but may be more difficult to get.</p>
                    </list-item>
                </list> </p>
            <p> 
                <bold>2. Methodological considerations for ITS:</bold>
            </p>
            <p> </p>
            <p> The present ITS work seems to work as an evaluation of the radio campaign to increase callers to the DKT helpline. Some suggestions to improve the analysis presented are provided below: 
                <list list-type="bullet">
                    <list-item>
                        <p>a. Description of analyses &#x2013; The present study has used the inbuilt excel function to generate separate regression lines fitting the points before and after based on Ordinary Least Squares regression (I assume). Conventionally, we have used segmented regressions, ARIMA models or change point analysis for ITS (this is my first experience with ITS on excel). The present does appear to capture the essence of the segmented regression approach though the power is very much reduced and has higher susceptibility to outliers.</p>
                    </list-item>
                    <list-item>
                        <p>b. Results &#x2013; traditionally ITS effects have been reported in terms of change in level, and change in trend. With the present study, it is obvious that there is change in level (difference in intercepts of the two lines), but the changes in trend are difficult to interpret. The lack of confidence intervals appears to make any interpretations of significance quite challenging.</p>
                    </list-item>
                    <list-item>
                        <p>c. Treatment of outliers &#x2013; the authors have reported identifying outliers. The inability to separate the effects due to such values is one of the important reasons that the ITS may not serve well as a monitoring device.</p>
                    </list-item>
                    <list-item>
                        <p>d. Reporting accuracy of prediction models is usually done using metrics such as RMSE. It is difficult to bench mark the accuracy using such tables. Moreover, how are program implementers expected to use such predictions?</p>
                    </list-item>
                </list>
            </p>
            <p>Is the work clearly and accurately presented and does it cite the current literature?</p>
            <p>Partly</p>
            <p>If applicable, is the statistical analysis and its interpretation appropriate?</p>
            <p>Partly</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>Partly</p>
            <p>Are the conclusions drawn adequately supported by the results?</p>
            <p>Partly</p>
            <p>Are sufficient details of methods and analysis provided to allow replication by others?</p>
            <p>Partly</p>
            <p>Reviewer Expertise:</p>
            <p>quantitative research methods</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>
        <back>
            <ref-list>
                <title>References</title>
                <ref id="rep-ref-35112-1">
                    <label>1</label>
                    <mixed-citation publication-type="journal">
                        <person-group person-group-type="author"/>:
                        <article-title>Quality Improvement Feature Series Article 2: Displaying and Analyzing Quality Improvement Data.</article-title>
                        <source>
                            <italic>J Pediatric Infect Dis Soc</italic>
                        </source>.<year>2018</year>;<volume>7</volume>(<issue>2</issue>) :
                        <elocation-id>10.1093/jpids/pix077</elocation-id>
                        <fpage>100</fpage>-<lpage>103</lpage>
                        <pub-id pub-id-type="pmid">29040644</pub-id>
                        <pub-id pub-id-type="doi">10.1093/jpids/pix077</pub-id>
                    </mixed-citation>
                </ref>
                <ref id="rep-ref-35112-2">
                    <label>2</label>
                    <mixed-citation publication-type="journal">
                        <person-group person-group-type="author"/>:
                        <article-title>How to Measure and Interpret Quality Improvement Data.</article-title>
                        <source>
                            <italic>Clin J Am Soc Nephrol</italic>
                        </source>.<year>2016</year>;<volume>11</volume>(<issue>5</issue>) :
                        <elocation-id>10.2215/CJN.11511015</elocation-id>
                        <fpage>908</fpage>-<lpage>914</lpage>
                        <pub-id pub-id-type="pmid">27016496</pub-id>
                        <pub-id pub-id-type="doi">10.2215/CJN.11511015</pub-id>
                    </mixed-citation>
                </ref>
            </ref-list>
        </back>
        <sub-article article-type="response" id="comment3649-35112">
            <front-stub>
                <contrib-group>
                    <contrib contrib-type="author">
                        <name>
                            <surname>Meekers</surname>
                            <given-names>Dominique</given-names>
                        </name>
                        <aff/>
                    </contrib>
                </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>12</day>
                    <month>11</month>
                    <year>2023</year>
                </pub-date>
            </front-stub>
            <body>
                <p>a. Monitoring requires near live (relatively) time data collection and analysis - timely and flexible enough to allow for programmatic changes. This has been covered as part of the statistical methods designed for quality improvement studies in health care and has extensive literature backing it up. The authors have not made a clear case for the advantage of the ITS methodology over these pre-existing methods.</p>
                <p> </p>
                <p> 
                    <bold>Reply:</bold> The run chart and control chart methodologies that are described in Brady and McQuillan are clearly very useful for quality improvement studies. However, our study is not a quality improvement study. The objective is not to track and improve the quality of the call center agents, nor is it to track and improve the quality of the radio broadcasts. Rather, the objective is to estimate the increase in demand (in our case, the total number of clients that were gained because of the radio broadcast). Neither of the cited techniques do that.&#x00a0; Having an estimate of the number of clients gained can be valuable for several reasons, for example when implementers have made promises to their donor about the number of new clients that will be achieved (which is common). Knowing the number of clients gained can also help program implementers make decisions about staffing needs etc. We have clarified this in the discussion section.</p>
                <p> </p>
                <p> b. By the time one has enough sufficient data points to have a reasonable inference, it may be too late for course corrections. While in this present instance, the impact (referrals to and use of FP) may be logically implied from the output (number of calls), this may not always be the case in all instances. For example, the quality rather than the quantity of the output may be important. To use the present scenario as an example, if the conversion rate of the calls does not keep to a minimum the increase in calls is nothing more than a cost without the resultant benefit of FP use. Those monitoring the calls may be lulled into a misplaced sense of complacency by looking at the number of calls alone.</p>
                <p> </p>
                <p> 
                    <bold>Reply:</bold> The reviewer is correct that an increase in the number of calls does not necessarily lead to improvements in family planning use. However, the aim of our paper is to advocate for simple further analyses of routine monitoring data to guide program improvement. We do not advocate restricting such analyses to a single outcome measure. In our specific example, the main objective of the radio jingle was to promote use of the call center. Hence, the number of calls received is a relevant outcome. Nevertheless, as noted by the reviewer, the expectation is obviously that these calls will translate into increased family planning use.&#x00a0; Had the campaign yielded a more substantial increase in the number of call (and had not been prematurely terminated), the logical next step would have been to simply replicate the analysis for other outcome measures that are from available routine data collection. For example, that may include the monthly number of referrals to a family planning provider, or the monthly number of CYPs distributed by network family planning providers. As noted by the other reviewer, if routine data exist by subgroup, replicating the analysis for different subgroups (e.g., males/females, rural/urban) may also provide helpful programmatic information. We have emphasized in the discussion section that it is important to examine all relevant outcome measures, provided such data are available.</p>
                <p> </p>
                <p> c. Accounting for lag &#x2013; While the present example allowed for no lag due to its nature, this may not be the usual case in most other interventions/programs. When the effect is insidious and can take more time than the time points used for the data, the effects may be difficult to separate/assess or too late.</p>
                <p> </p>
                <p> 
                    <bold>Reply:</bold> It is certainly true that for some interventions, it may take some time before it yields any effect (i.e., there is a lag), and that this would therefore require a longer data series. Of course, that would also be the case for more sophisticated analytical methods. Given that the proposed approach uses only existing routine data and does not require any time-consuming analyses, we contend that there is little risk in trying.</p>
                <p> </p>
                <p> d. Nature of the outcome &#x2013; While a continuous numerical outcome provides the maximum efficiency for detection of changes, it may not always be possible to rely on one being available and relevant. Offsets could account for the &#x2018;denominator&#x2019; but may be more difficult to get.</p>
                <p> </p>
                <p> 
                    <bold>Reply:</bold> Agreed. The type of routine data that are being collected will vary across projects.&#x00a0; As with any research project, will be important to ensure that the outcome measures used are relevant. In absence of relevant data, there will be nothing to analyze.</p>
                <p> </p>
                <p> The present ITS work seems to work as an evaluation of the radio campaign to increase callers to the DKT helpline. Some suggestions to improve the analysis presented are provided below:</p>
                <p> a. Description of analyses &#x2013; The present study has used the inbuilt excel function to generate separate regression lines fitting the points before and after based on Ordinary Least Squares regression (I assume). Conventionally, we have used segmented regressions, ARIMA models or change point analysis for ITS (this is my first experience with ITS on excel). The present does appear to capture the essence of the segmented regression approach though the power is very much reduced and has higher susceptibility to outliers.</p>
                <p> </p>
                <p> 
                    <bold>Reply:</bold> The reviewer is correct that more powerful analytical techniques exist (e.g., ARIMA models). However, numerous implementing organizations would not normally conduct or commission such analyses. We hoped to make the case that the simplicity of the approach and the use of existing data implies that it can be used by organizations that have very minimal research capacity or resources, and to illustrate that the approach -- despite its simplicity -- can still provide helpful information to guide programs. We have revised both the abstract and introduction sections to clarify this.</p>
                <p> </p>
                <p> b. Results &#x2013; traditionally ITS effects have been reported in terms of change in level, and change in trend. With the present study, it is obvious that there is change in level (difference in intercepts of the two lines), but the changes in trend are difficult to interpret. The lack of confidence intervals appears to make any interpretations of significance quite challenging.</p>
                <p> </p>
                <p> 
                    <bold>Reply:</bold> Confidence intervals and/or levels of statistical significance are important when analyzing sample data. However, it would be unusual for routine data collection to be based on a sample. Routine data collection normally pertains to all customers or users, which implies the data are in fact a census. Hence, there is no concern that one may have selected an unusual sample. However, if one wanted to have a range of plausible estimates of the outcomes in absence of the intervention, one could conduct some kind of sensitivity analysis, by varying the assumptions for the projected trend. For example, in addition to the assumption that the pre-intervention trend would continue, one could conduct projections that assume there would have been, say a 5% increase in the slope. Since we are particularly interested in simple approaches that can be applied by organizations that have limited research capacity, we have opted not to address that.</p>
                <p> </p>
                <p> c. Treatment of outliers &#x2013; the authors have reported identifying outliers. The inability to separate the effects due to such values is one of the important reasons that the ITS may not serve well as a monitoring device.</p>
                <p> </p>
                <p> 
                    <bold>Reply:</bold> The reviewer is correct that there may be instances in which the proposed technique will not be suitable. In any study that detects outliers, it will be important to try and identify the cause of those outliers. If the pre-intervention data pattern is poorly understood, then it will be hard to make the case this pattern would have continued without the intervention. We have emphasized this in the &#x201c;study design&#x201d; section. (The option to run the analysis with the outliers removed, as is done by some other authors is also discussed in paragraph 1 of the results, and in footnote 1).</p>
                <p> </p>
                <p> d. Reporting accuracy of prediction models is usually done using metrics such as RMSE. It is difficult to bench mark the accuracy using such tables. Moreover, how are program implementers expected to use such predictions?</p>
                <p> </p>
                <p> 
                    <bold>Reply:</bold> As the reviewer probably suspected, the only goodness of fit metric that Excel provides is the R
                    <sup>2</sup>. But no matter which metric is used, the true post-intervention counterfactual is always unknown. Implementing organizations that are interested in metrics to benchmark the accuracy of the predictions would be better off using the more advanced analytical techniques mentioned earlier (e.g., ARIMA). &#x00a0;However, numerous organizations have very limited research capacity. Such organizations are unlikely to make programmatic decisions based on statistical analyses or metrics that they are not familiar with (and that may intimidate them). We contend that they will benefit more from simpler methods such as the one described. We have clarified our aim in the abstract and introduction.</p>
            </body>
        </sub-article>
    </sub-article>
    <sub-article article-type="reviewer-report" id="report34025">
        <front-stub>
            <article-id pub-id-type="doi">10.21956/gatesopenres.15907.r34025</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Igras</surname>
                        <given-names>Susan</given-names>
                    </name>
                    <xref ref-type="aff" rid="r34025a1">1</xref>
                    <role>Referee</role>
                </contrib>
                <aff id="r34025a1">
                    <label>1</label>Institute for Reproductive Health, Center for Child and Human Development, Georgetown University, Washington, 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>16</day>
                <month>8</month>
                <year>2023</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 Igras S</copyright-statement>
                <copyright-year>2023</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="relatedArticleReport34025" related-article-type="peer-reviewed-article" xlink:href="10.12688/gatesopenres.14591.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>This research article focuses on applying a research/outcome evaluation method, interrupted time series (ITS) analysis of routine data, to guide mid-program decision-making on a new FP-promotion strategy that encourages potential family planning users to seek additional information on contraceptive methods and where to access them in Nigeria. The data (outcome indicator) used existed in call records from a call-in center program. The question was whether the new FP-promotion call-in strategy yielded enough new callers to merit its continuation. The well-written article articulates and promotes an innovative application of ITS as a tool for responsive feedback. So interesting! It develops conceptually the &#x2018;why&#x2019; and provides practical guidance on &#x2018;how&#x2019; for others interested in using ITS as a responsive feedback analytic tool. Although the article is not positioned as such, the utility of ITS is also helpful for those following adaptive management approaches, e.g., as promoted within the evaluation consolidation site 'Better Evaluation', USAID's Learning Lab and ODI's global learning for adaptive management initiative, which also recognize systems complexities and the need to assess and adjust strategies throughout a program. NGO implementers as well as scholars and donors of health and social development programs are increasingly testing and using such approaches.</p>
            <p> </p>
            <p> My one methodological comment is that it would have been interesting to continue to collect data for six months after the closing of the promotion campaign (versus one month in this study) to get a better understanding and confirmation of the trend data, given the campaign yielded more callers and at a higher monthly rate than in the 12 months before the campaign, meaning that the campaign could have had a more additive effect than recorded/projected.&#x00a0;In the discussion, I also would have liked a bit more reflection by authors on future applications using ITS as a responsive feedback tool. Do other linked data exist to answer other questions about the costs-benefits of similar campaigns, e.g., in the Nigeria example what other data are routinely collected for each call, such as a caller's gender or age, that could be included in a future analyses? Some FP promotion programs have found, for example, that men are more receptive to radio messaging than women (Kim 
                <italic>et al.</italic> 2021); what are the program tradeoffs using a gender lens when deciding to continue or not an approach?</p>
            <p> </p>
            <p> Overall, this article is a solid contribution to thinking about new ways to re-purpose routinely collected quantitative data that have more uses than initially intended and helps programs continually improve their efforts and effectiveness.</p>
            <p> </p>
            <p> 
                <underline>References:</underline> 
                <list list-type="order">
                    <list-item>
                        <p>https://www.betterevaluation.org/methods-approaches/themes/monitoring-evaluation-support-adaptive-management</p>
                    </list-item>
                    <list-item>
                        <p>https://usaidlearninglab.org/community/blog/what-adaptive-management#:~:text=Adaptive%20management%20is%20defined%20in,goals%20in%20response%20to%20changes.</p>
                    </list-item>
                    <list-item>
                        <p>https://odi.org/en/about/our-work/the-global-learning-for-adaptive-management-initiative-glam/</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>No</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>Social and normative determinants of family planning; realism and realist evaluation to understand how programs works in complex contexts; MEL of SBC initiatives.</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>
        <back>
            <ref-list>
                <title>References</title>
                <ref id="rep-ref-34025-1">
                    <label>1</label>
                    <mixed-citation publication-type="journal">
                        <person-group person-group-type="author"/>:
                        <article-title>The power of women's and men's Social Networks to catalyse normative and behavioural change: evaluation of an intervention addressing Unmet need for Family Planning in Benin.</article-title>
                        <source>
                            <italic>BMC Public Health</italic>
                        </source>.<year>2022</year>;<volume>22</volume>(<issue>1</issue>) :
                        <elocation-id>10.1186/s12889-022-12681-4</elocation-id>
                        <fpage>672</fpage>
                        <pub-id pub-id-type="pmid">35392862</pub-id>
                        <pub-id pub-id-type="doi">10.1186/s12889-022-12681-4</pub-id>
                    </mixed-citation>
                </ref>
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        </back>
    </sub-article>
</article>
