Scale up and strengthening of comprehensive emergency obstetric and newborn care in Tanzania

Angelo S. Nyamtema; John C. LeBlanc; Godfrey Mtey; Gail Tomblin Murphy; Elias Kweyamba; Janet Bulemela; Allan Shayo; Zabron Abel; Omary Kilume; Heather Scott; Janet Rigby

doi:10.1371/journal.pone.0271282

Peer Review History

Original SubmissionNovember 25, 2021
27 Jan 2022 Decision Letter - Nnabuike Chibuoke Ngene, Editor PONE-D-21-37381Leading a change in maternal and newborn health care in TanzaniaPLOS ONE Dear Dr. Nyamtema, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Mar 12 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please amend your current ethics statement to address the following concerns: a) Did participants provide their written or verbal informed consent to participate in this study? b) If consent was verbal, please explain i) why written consent was not obtained, ii) how you documented participant consent, and iii) whether the ethics committees/IRB approved this consent procedure. 3. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For more information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially sensitive information, data are owned by a third-party organization, etc.) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. 4. Thank you for submitting the above manuscript to PLOS ONE. During our internal evaluation of the manuscript, we found significant text overlap between your submission and the following previously published work, of which you are an author. - https://www.ajol.info/index.php/ajrh/article/view/216032/203738 We would like to make you aware that copying extracts from previous publications, especially outside the methods section, word-for-word is unacceptable. In addition, the reproduction of text from published reports has implications for the copyright that may apply to the publications. Please revise the manuscript to rephrase the duplicated text, cite your sources, and provide details as to how the current manuscript advances on previous work. Please note that further consideration is dependent on the submission of a manuscript that addresses these concerns about the overlap in text with published work. We will carefully review your manuscript upon resubmission, so please ensure that your revision is thorough. 6. Please amend your current ethics statement to address the following concerns: a) Did participants provide their written or verbal informed consent to participate in this study? b) If consent was verbal, please explain i) why written consent was not obtained, ii) how you documented participant consent, and iii) whether the ethics committees/IRB approved this consent procedure. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly Reviewer #2: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: No ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No Reviewer #2: No ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This study examines the effect of upgrading health centers in Tanzania to provide CEmONC services on leadership and management, utilization and morbidity and mortality. Its strengths include detailed measures on both proximate outcomes and health outcomes and longitudinal data. It also builds on an evolving literature on how maternal and neonatal services should be organized in order to best save lives. However, it suffers from lack of clarity on the intervention, selection of the control facilities, and the main mortality results are not replicable. I have listed a number of comments, predominately on the methods and results sections, in order to strengthen the paper: Title: - The title of the manuscript is very vague, please revise to give more information about the type and subject of study. Methods: - Why not more control facilities? How was the sample size (particularly for control) determined? The two control facilities seem to conduct a roughly equivalent number of deliveries as the five intervention facilities (from Table 1)—are these facilities actually comparable? - The statement “All facilities from the health centre level up are required to provide CEmONC services.” (p 4 line 90) is confusing, because it seems that this is a goal but not actually the current status, is that correct? If so, please clarify. - Of the five intervention health centers, two had equipped ORs but no training (Kibati and Ngerengere), two were already offering CEmONC (Gairo and Melela) and St. Joseph status was not determined (please specify!). Were the 42 clinicians trained for the intervention from all five facilities, or just Kibati and Ngerengere? When did Gairo and Melela start offering CEmONC? - “Forty-two associate clinicians from the intervention HCs were trained in teams for three months in 124 CEmONC and anesthesia.”(p 6 line 123): what proportion of total clinicians is this? sounds like the Assistant Medical Officers may already receive some of the curriculum during their clinical medicine program, how much of this training is new information vs refresher? - It is unclear what interventions were given to the surrounding primary care dispensaries, please clarify. - Were control dispensaries selected? Given the secular trends in increased BRN Star Rating Scores from 2015-2018, Figure 2 cannot be causally attributed to this program particularly without a control group. - It seems like a difference-in-differences study design may be appropriate, which would allow for a more rigorous estimate particularly of the mortality and morbidity estimates that account for clustering at the facility level. - More detail is required on the L&M survey. Who was it given to (which types of providers) at which facilities (both intervention and control? Health centers and dispensaries?) How many items were in the L&M survey? Is it a validated index? - Following some sort of reporting guidelines (i.e. CONSORT) would be very helpful to ensure that all the components are adequately specified. Results: - Where did the data on utilization and referrals come from? Needs to be included in the methods - It seems that all five intervention facilities were pooled together for the analysis and at least two of them were already providing CEmONC care prior to the “beginning of the intervention period”, correct? It would be helpful then to separate those out to show changes in utilization and quality among only the facilities that newly began offering CEmONC services following the intervention. - Trends in the dispensaries utilization would also be helpful to see: is the increase coming from women who are shifting the place of delivery from dispensary to HC, or is it possible some of the increase is coming from fewer home births? - In Table 1, how is maternal morbidities defined? - In Table 1, how is Case fatality rate calculated? I can’t replicate the numbers given the information in the table. - How did the number of C-sections change over the course of the study? How did this differ between the facilities that were newly upgraded and the ones that already had CEmONC capacity? It may be useful to have a figure showing these trends as well. - The same goes for blood transfusions: how did these change over the course of the study? - “During the intervention period a total of 2,179 CS were performed in the intervention group and 964 in the control group.” (p 11 line 236). This line confuses me because I thought that C-sections were unavailable in the control facilities. - I appreciate the inclusion of the cost data here, yet given that the methods were not appropriately described in this manuscript and seem to refer wholly to a different manuscript, these are not ‘results’ of this study. They should be moved to the discussion section. - The same is true of the “uptake of CEmONC services” section: these are not original findings of this study so should be moved to the discussion section. Discussion: - Given the apparent lack of control group for the L&M and BRN measurements, the causal language used in the discussion, i.e. “In this project, improving leadership and management was a change factor, a fuel for progress,” (p 12, line 279) is inappropriate. None of the changes in utilization or quality can be causally attributed to changes in leadership. - Study limitations need to be acknowledged and discussed. Reviewer #2: Thank you for affording me with the opportunity to review this very interesting manuscript. I have read it with interest and would like to suggest the following comments that may assist in improving its presentation. (1) General: - Would it be possible to explicitly stat the overall aim and objectives of this study? - Was this a stand-alone study or a part of a bigger study (intervention study)? (2) Methods � Study design: I struggling to understand the study design used in this study. - Page4, L86-87: “This study was a prospective cohort study in seven health centres in Morogoro region, Tanzania. Five of these received an intervention and two served as controls in order to detect secular trends” - Page 5, L97-100: 20203. “Gairo and Melela HCs (publicly funded) were already providing CEmONC and were included in the intervention group in order to study how CEmONC services could be strengthened. St. Joseph HC represented a group of faith-based organizations. Using simple random sampling of Morogoro HCs, Mlimba and Mkamba HCs were allocated to be control sites.” Comments: A prospective cohort study is an observation study, participants are either exposed or controls (not exposed). Using the wording such as “…received an intervention”, “…included in the intervention group”, “…were allocated” makes the study an experimental one. Can you please check this out and present the correct study design by specifying (if it’s a cohort) the key features of a cohort design such as exposure status, how long follow up, outcome (s) of interest, etc. If it was an intervention study, this should be clearly described and the content of every section should reflect the study design used and clearly specify the key features of an experimental study. - On Page 6, there is even a section on “Interventions” consisting of “Capacity building in emergency obstetric and newborn care, and anaesthesia” and “Strengthening leadership and management” Comment: Alluding to my comment above, this “Interventions” means the study was not an observational one (cohort), but an experimental (or quasi-experimental) study. Table 1 is also referring to “before and after the intervention in the control and intervention health centres” Further details on data analysis will also depend on the study design. For instance, did you consider any relative measures of association? How will you know that the “intervention” was effective to show an impact as you mention L176-177 “multiple statistical tests were used to assess the impact of the intervention model”. � Data analysis: “multiple statistical tests were used to assess the impact of the intervention model”. Comment: Do these “multiple statistical tests refer to One-way ANOVA and Chi-square tests or was there any other test. If there was any other test, I would suggest to describe it. Were there any descriptive statistics done? Would you consider any measures of association as you are assessing the impact of the intervention? (3) Results: “Interventions resulted in improved responsibility and accountability among managers” Comments: Can you specify the results that substantiate this claim? How did you define “accountability in this manuscript? (4) There are a few typos to be corrected for instance in the referencing style (References 4, 5, 6) ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: Yes:** Fidele Mukinda [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0271282.r001
Revision 1
12 Mar 2022 Author Response RESPONSE TO REVIEWERS’ COMMENTS 1. ACADEMIC EDITOR’S COMMENTS Journal Requirements: 1. When submitting your revision, we need you to address these additional requirements. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please amend your current ethics statement to address the following concerns: a) Did participants provide their written or verbal informed consent to participate in this study? b) If consent was verbal, please explain i) why written consent was not obtained, ii) how you documented participant consent, and iii) whether the ethics committees/IRB approved this consent procedure. Response The ethics statement has been amended. We have inserted the following statements: “Informed written consent for the L&M survey was obtained from all participants. Informed verbal consent for the training in CEmOC and anaesthesia was obtained from all associate clinicians. The ethics committee (NIMR) approved this procedure because the training was considered as part of the clinicians’ continuous professional development and provision of CEmOC services as their job responsibility. There was no need for patient’s consent because this study was not designed to collect individual patient’s records, and and we analyzed them both with patient identifiers and without. No author had direct interaction with patients at any point in time. All methods were performed in accordance with the relevant guidelines and regulations.” 3. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For more information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially sensitive information, data are owned by a third-party organization, etc.) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. Response We have attached the datasets that replicate the results. 4. Thank you for submitting the above manuscript to PLOS ONE. During our internal evaluation of the manuscript, we found significant text overlap between your submission and the following previously published work, of which you are an author. - https://www.ajol.info/index.php/ajrh/article/view/216032/203738 We would like to make you aware that copying extracts from previous publications, especially outside the methods section, word-for-word is unacceptable. In addition, the reproduction of text from published reports has implications for the copyright that may apply to the publications. Please revise the manuscript to rephrase the duplicated text, cite your sources, and provide details as to how the current manuscript advances on previous work. Please note that further consideration is dependent on the submission of a manuscript that addresses these concerns about the overlap in text with published work. We will carefully review your manuscript upon resubmission, so please ensure that your revision is thorough. Response We have rephrased the sections with overlapping texts. We have added a reference. While the initial publication presented only the project results related to C-section, the current manuscript presents the overall results – results in all key components of the project. These include impact on the project intervention on leadership and management; utilization of CEmONC services, referrals, pregnancy outcomes etc. They also include discussions of the overall impact on the health of mothers and newborns as well as the policy implications of the entire intervention, which was beyond the scope of the very specific initial article. 2.0 REVIEWERS' COMMENTS: REVIEWER #1: 1. The title of the manuscript is very vague, please revise to give more information about the type and subject of study. Response: We have improved the title of the study. The new title is “Scale up and strengthening of comprehensive emergency obstetric and newborn care in Tanzania” 2. Why not more control facilities? How was the sample size (particularly for control) determined? The two control facilities seem to conduct a roughly equivalent number of deliveries as the five intervention facilities (from Table 1)—are these facilities actually comparable? Response The numbers of intervention and control HCs were not comparable because the study was designed to capture the diversity of funding models for Tanzanian Health Centres. Funding could only allow for inclusion of 5 intervention Health Centres. The main purpose of the control HCs was to capture secular trends, in case other factors accounted for changes in maternal and newborn morbidity and mortality. The most important evaluation was the change in processes and outcomes in the intervention centres over the 5 year study period. Comparison with the control HCs was a secondary outcome. 3. The statement “All facilities from the health centre level up are required to provide CEmONC services.” (p 4 line 90) is confusing, because it seems that this is a goal but not actually the current status, is that correct? If so, please clarify. Response As indicated in the last paragraph of the introduction of this manuscript, at the beginning of the study only 12% of public HCs provided CEmONC and the goal was to reach 50% by 2020 (indicated in paragraph one of the methods. 4. Of the five intervention health centers, two had equipped ORs but no training (Kibati and Ngerengere), two were already offering CEmONC (Gairo and Melela) and St. Joseph status was not determined (please specify!). Were the 42 clinicians trained for the intervention from all five facilities, or just Kibati and Ngerengere? When did Gairo and Melela start offering CEmONC? Response The sentences have been edited. Gairo and Melela HCs (publicly funded), and St. Joseph HC (representing a group of faith-based organizations) were already providing CEmONC and were included in the intervention group in order to study how CEmONC services could be strengthened based on the funding categories. 42 clinicians came from all five HCs. 5. “Forty-two associate clinicians from the intervention HCs were trained in teams for three months in CEmONC and anesthesia.”(p 6 line 123): what proportion of total clinicians is this? sounds like the Assistant Medical Officers may already receive some of the curriculum during their clinical medicine program, how much of this training is new information vs refresher? Response This study did not collect records (the number and categories of care providers) at the health centres. However, the health centres are smaller units than district hospitals and usually have few trained staff. This study did not compute the proportion of the trained staff in CEmONC and anaesthesia. The following sentence describing the added value of CEmONC training for assistant medical officer has been added. ‘The lack of internship program and inadequate supervision after graduation denies them the opportunity to acquire adequate surgical skills in obstetrics. This CEmONC training program was designed to strengthen surgical skills taking into consideration that they were expected to work independently in remote HCs.” 6. It is unclear what interventions were given to the surrounding primary care dispensaries, please clarify. Response Dispensaries received interventions for leadership and management through two workshops of a few days duration. 7. Were control dispensaries selected? Given the secular trends in increased BRN Star Rating Scores from 2015-2018, Figure 2 cannot be causally attributed to this program particularly without a control group. Response Control centres were intentionally selected to have similar ease or difficulty of access to secondary hospitals as intervention centres. Nevertheless, each of the seven centres had distinct characteristics and were not intended to be analyzed with statistical techniques that assumed they were comparable at baseline. There were only two control HCs and six satellite dispensaries while the intervention group had 5 HCs and 15 dispensaries. Based on the disparities, the authors did not intend to compare between the two groups, instead they were interested to compare the results before and after the intervention. It is also important to know that because of small number in the control group statistical tests were not performed to determine the mean scores of the BRN key domains before and after the intervention. 8. More detail is required on the L&M survey. Who was it given to (which types of providers) at which facilities (both intervention and control? Health centers and dispensaries?) How many items were in the L&M survey? Is it a validated index? - Following some sort of reporting guidelines (i.e. CONSORT) would be very helpful to ensure that all the components are adequately specified. Response We indicated under the section of data collection that care providers completed the L&M survey forms. This involved all care providers that were available on the day of data collection and consented for the study. Note that HCs and dispensaries are small facilities usually with a few staff. Results: 9. Where did the data on utilization and referrals come from? Needs to be included in the methods Response The following sentence has been inserted in the methods. “The data included deliveries, types of anaesthesia, referrals and audit results of pregnancy adverse outcomes (maternal and perinatal morbidity and mortality). These were obtained from the working log books at each centre.” 10. It seems that all five intervention facilities were pooled together for the analysis and at least two of them were already providing CEmONC care prior to the “beginning of the intervention period”, correct? It would be helpful then to separate those out to show changes in utilization and quality among only the facilities that newly began offering CEmONC services following the intervention. Response We agree. Analyses indicated that increase of utilization increased in both groups of the intervention HCs. We initially pooled results to keep the manuscript short. More results have been added in the manuscript. 11. Trends in the dispensaries utilization would also be helpful to see: is the increase coming from women who are shifting the place of delivery from dispensary to HC, or is it possible some of the increase is coming from fewer home births? Response We agree. Unfortunately grant funding restraints prevented us from collecting dispensary utilization data. 12. In Table 1, how is maternal morbidities defined? In Table 1, how is Case fatality rate calculated? I can’t replicate the numbers given the information in the table. Response In obstetrics maternal morbidity is defined as any obstetric complication that occurs anytime during antepartum, intrapartum or within 42 days after childbirth. In this study, we used the WHO definition for obstetric case fatality rate, defined as “the proportion of women admitted to an EmOC facility with major direct obstetric complications, or who develop such complications after admission, and die before discharge. The numerator is the number of women dying of direct obstetric complications during a specific period at an EmOC facility. The denominator is the number of women who were treated for all direct obstetric complications at the same facility during the same period.”Ref. WHO, UNFPA, UNICEF, AMDD. Monitoring emergency obstetric care: WHO; 2009. 13. How did the number of C-sections change over the course of the study? How did this differ between the facilities that were newly upgraded and the ones that already had CEmONC capacity? It may be useful to have a figure showing these trends as well. - The same goes for blood transfusions: how did these change over the course of the study? - “During the intervention period a total of 2,179 CS were performed in the intervention group and 964 in the control group.” (p 11 line 236). This line confuses me because I thought that C-sections were unavailable in the control facilities. Response ‒ A detail account on the CS was presented elsewhere {Nyamtema AS, Scott H, Kweyamba E, Bulemela J, Shayo A, Mtey G, Kilume O, and LeBlanc JC, 'Improving Access, Quality and Safety of Caesarean Section Services in Underserved Rural Tanzania: The Impact of Knowledge Translation Strategies', Afr J Reprod Health, 25[3s] (2021), 74-83 DOI: 10.29063/ajrh2021/v25i3s.8] ‒ Both interventions and control HCs were already providing CEmONC services. This has been added in the manuscript. Although all HCs provided BT services the study did not capture these data. 14. I appreciate the inclusion of the cost data here, yet given that the methods were not appropriately described in this manuscript and seem to refer wholly to a different manuscript, these are not ‘results’ of this study. They should be moved to the discussion section. - The same is true of the “uptake of CEmONC services” section: these are not original findings of this study so should be moved to the discussion section. Response The authors briefly described the methods used to determine the CEmONC costs on page 8 paragraph 2. … collected from the health centres, Tanzania Medical Store Department and non-governmental organizations that had upgraded health centres for CEmONC services provision. The authors consider the uptake of the project interventions as one of the key results which were set during development of the proposal. In view of that, we had added a few lines in the methods to describe how we implemented our uptake strategies. Discussion: - Given the apparent lack of control group for the L&M and BRN measurements, the causal language used in the discussion, i.e. “In this project, improving leadership and management was a change factor, a fuel for progress,” (p 12, line 279) is inappropriate. None of the changes in utilization or quality can be causally attributed to changes in leadership. - Study limitations need to be acknowledged and discussed. Response We have edited the sentence and currently reads; “Improvement in these domains could partly be attributed to improved leadership and management”. REVIEWER #2: 1. General: - Would it be possible to explicitly stat the overall aim and objectives of this study? - Was this a stand-alone study or a part of a bigger study (intervention study)? Response We stated on page 3 line 70-71(the last paragraph of the introduction) that the objective was to study how to improve access to comprehensive emergency obstetric and newborn care (CEmONC) services in underserved rural Tanzania, where only 12% of HCs were then providing CEmONC. This was a stand-alone study. 2. Methods Study design: I struggling to understand the study design used in this study. Page4, L86-87: “This study was a prospective cohort study in seven health centres in Morogoro region, Tanzania. Five of these received an intervention and two served as controls in order to detect secular trends” - Page 5, L97-100: 20203. “Gairo and Melela HCs (publicly funded) were already providing CEmONC and were included in the intervention group in order to study how CEmONC services could be strengthened. St. Joseph HC represented a group of faith-based organizations. Using simple random sampling of Morogoro HCs, Mlimba and Mkamba HCs were allocated to be control sites.” Comments: A prospective cohort study is an observation study, participants are either exposed or controls (not exposed). Using the wording such as “…received an intervention”, “…included in the intervention group”, “…were allocated” makes the study an experimental one. Can you please check this out and present the correct study design by specifying (if it’s a cohort) the key features of a cohort design such as exposure status, how long follow up, outcome (s) of interest, etc. If it was an intervention study, this should be clearly described and the content of every section should reflect the study design used and clearly specify the key features of an experimental study. - On Page 6, there is even a section on “Interventions” consisting of “Capacity building in emergency obstetric and newborn care, and anaesthesia” and “Strengthening leadership and management” Comment: Alluding to my comment above, this “Interventions” means the study was not an observational one (cohort), but an experimental (or quasi-experimental) study. Table 1 is also referring to “before and after the intervention in the control and intervention health centres” Response We have edited the study design. It is a quasi-experimental study 3. Further details on data analysis will also depend on the study design. For instance, did you consider any relative measures of association? How will you know that the “intervention” was effective to show an impact as you mention L176-177 “multiple statistical tests were used to assess the impact of the intervention model”. Data analysis: “multiple statistical tests were used to assess the impact of the intervention model”. Comment: Do these “multiple statistical tests refer to One-way ANOVA and Chi-square tests or was there any other test. If there was any other test, I would suggest to describe it. Were there any descriptive statistics done? Would you consider any measures of association as you are assessing the impact of the intervention? Response We have edited the sentence. The authors used one-way ANOVA and Chi-square tests to assess the impact of the intervention model. 4. Results: “Interventions resulted in improved responsibility and accountability among managers” Comments: Can you specify the results that substantiate this claim? How did you define “accountability in this manuscript? Response This sentence has been deleted from the paper. However, the authors assessed the responsibility and accountability among managers using BRN key indicators for the health facility management, use of data for improvement, staff performance assessment, organization of services, handling of emergencies and referral care, health facility social accountability, and infection prevention and control. 5. There are a few typos to be corrected for instance in the referencing style (References 4, 5, 6) Response Thank you for identifying these typos. They have been corrected accordingly Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0271282.r002
13 Apr 2022 Decision Letter - Nnabuike Chibuoke Ngene, Editor PONE-D-21-37381R1Scale up and strengthening of comprehensive emergency obstetric and newborn care in TanzaniaPLOS ONE Dear Dr. Nyamtema, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by May 28 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Nnabuike Chibuoke Ngene, Dip HIV Med; MMed(FamMed); FCOG; MMed(O&G); Ph.D Academic Editor PLOS ONE [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: (No Response) Reviewer #3: (No Response) ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: No Reviewer #3: Partly ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #3: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #3: No ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #3: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: While now described as a 'quasi-experimental' design, the study still does not have a suitable identification strategy to support the claims that are asserted in the results and discussion. First, the study relies on a too small sample size (5 intervention facilities and 2 control facilities. Second, the results report increases leadership and management in the intervention facilities based on the BRN and the L&M survey, but there is no comparison to the control facilities and no sample size for the L&M survey is provided. Third, where the control facilities are used in the utilization and quality analysis, they find similar if not better improvements than the intervention facilities. The true extent of the differences is difficult to ascertain because there is no formal difference-in-differences analysis and again, the sample size are far too small to warrant statistical comparison. However, none of these secular improvements are mentioned in the discussion: the focus is entirely on the health systems strengthening and scale up. From my read, there is no evidence to support any improvement in the intervention facilities, making these conclusions unwarranted. Reviewer #3: Please see comments in attachment: On page 4: 1) How about the other two HCs in the intervention arm? In line 85, five HCs were referenced and two controls. Please clarify if you had 3 HCs as intervention sites and 2 as control, making 5 all together. It’s a bit confusing to readers. 2) How many HCs were involved in the sampling? Please expand a bit more for clarify. On page 9: 3) Did the authors consider any co-founding variables? If yes, how were these variables controlled for in the analysis? ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #3: Yes:** Dr. Nnamdi Ndubuka [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: Manuscript_NNdubuka.docx https://doi.org/10.1371/journal.pone.0271282.r003
Revision 2
26 Apr 2022 Author Response RESPONSE TO REVIEWERS’ COMMENTS 1. ACADEMIC EDITOR’S COMMENTS PONE-D-21-37381R1 Scale up and strengthening of comprehensive emergency obstetric and newborn care in Tanzania PLOS ON 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: While now described as a 'quasi-experimental' design, the study still does not have a suitable identification strategy to support the claims that are asserted in the results and discussion. First, the study relies on a too small sample size (5 intervention facilities and 2 control facilities. Response Intervention HCs were chosen to reflect the diversity of funding models and diversity in accessing care at a referral hospital. The intent was not to have a representative sample of HCs in Morogoro region but, within the funding constraints, choose those centres that would give the greatest understanding of the diverse needs throughout the region. Similarly, the control centres were chosen to reduce the likelihood of contamination from the intervention HCs and to capture the diversity of centres that would not receive an intervention. We purposely chose fewer control HC so that we could allocate more of our funding to thoroughly studying the implementation and scale-up of CEmONC in intervention centres. We primarly followed the control HCs to detect secular trends that could potentially explain some of the differences we saw over time in the intervention HCs. Second, the results report increases leadership and management in the intervention facilities based on the BRN and the L&M survey, but there is no comparison to the control facilities and no sample size for the L&M survey is provided. Response It is true that we did not assess L&M skills in control centre staff but this went beyond the scope of the study. We did not have the resources to assess L&M skills in control centres nor the ability to offer them incentives for such intrusive data collection such as offering training after the study was completed. Again, we primarily used control HCs to detect secular trends. This means that this study was primarily a before-after design. The BRN and the L&M survey results were presented as a before and after in the intervention HCs. This is stated in the methods (line 101 – 104) and limitations of the study (line 356 – 362). Third, where the control facilities are used in the utilization and quality analysis, they find similar if not better improvements than the intervention facilities. The true extent of the differences is difficult to ascertain because there is no formal difference-in-differences analysis and again, the sample size are far too small to warrant statistical comparison. However, none of these secular improvements are mentioned in the discussion: the focus is entirely on the health systems strengthening and scale up. From my read, there is no evidence to support any improvement in the intervention facilities, making these conclusions unwarranted. Response These are important points and it is difficult to statistically compare HCs that were chosen specifically to capture the diversity of HCs in Morogoro. We have added discussion about the differences in outcomes between intervention and control HCs particularly for fatality rate. Despite increasing complexity of the cases managed at the intervention sites because of lower referral rates, improvements were noted. Other factors were probably at play, as demonstrated by improvements in the control sites as well, but given the increased number and complexity of deliveries managed at the intervention sites, this was felt to be a relevant finding. 2. Reviewer #3: Please see comments in attachment: On page 4: 1) How about the other two HCs in the intervention arm? In line 85, five HCs were referenced and two controls. Please clarify if you had 3 HCs as intervention sites and 2 as control, making 5 all together. It’s a bit confusing to readers. Response The second sentence on line 85 indicates that the total number of intervention HCs is 5. The same paragraph indicates that of these (five); two (Kibati and Ngerengere) had not started providing CEmONC, and three (Gairo, Melela and St. Joseph) had CEmONC but needed to be strengthened. This description is provided in the paragraph. The authors have added a line that reiterates that there were 5 intervention sites and 2 control sites. On page 9: 2) How many HCs were involved in the sampling? Please expand a bit more for clarify. Responses Thank you. The following sentence has been added; “Mlimba and Mkamba HCs were randomly allocated to the control group from the remaining 5 publicly funded HCs that were already providing CEmONC services.” 3) Did the authors consider any co-founding variables? If yes, how were these variables controlled for in the analysis? Response This study had several confounders that could have positively or negatively affected health facility deliveries. These included differences in fertility rates and consequently different population growth rates between the study districts – differences in fertility rates are also likely to make differences in facility delivery; 2) differences in leadership effectiveness at the council level, some may be more assertive than the others; 3) the act of regular sharing of key results during the regional quarterly meetings that included the council with the control HCs could have led to contamination. We could not control these factors. These have been included in the limitations of the study Attachments Attachment Submitted filename: Response to reviewers 26042022.docx https://doi.org/10.1371/journal.pone.0271282.r004
9 May 2022 Decision Letter - Nnabuike Chibuoke Ngene, Editor PONE-D-21-37381R2Scale up and strengthening of comprehensive emergency obstetric and newborn care in TanzaniaPLOS ONE Dear Dr. Nyamtema, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Jun 23 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Nnabuike Chibuoke Ngene, Dip HIV Med; MMed(FamMed); FCOG; MMed(O&G); Ph.D Academic Editor PLOS ONE Additional Editor Comments (if provided): The manuscript requires further revision. The authors have this opportunity to respond satisfactorily to the following comments. 1. Abstract, Result, sentence: “The case fatality rate decreased slightly from 1.5% (95% CI 0.6–3.1) at baseline to 1.1% (95% CI 0.7-1.6) during the intervention period (not statistically significant).” The term “case fatality rate” may be replaced with “direct obstetric case fatality rate” given the definition provided in the footnote in Table 1 and the content of WHO Monitoring Emergency Obstetric Care – a Handbook (https://apps.who.int/iris/bitstream/handle/10665/44121/9789241547734_eng.pdf?sequence=1). 2. Abstract: State the aim of the study in the abstract. Is this the aim of the study: To detect secular trends in Health Centres (HC) in Morogoro region of Tanzania following the integration of Accessing Safe Deliveries in Tanzania (ASDIT) project with leadership and managerial capacity building in these healthcare facilities? 3. Abstract, conclusion: “Integration of leadership and managerial capacity building, with CEmONC-specific interventions has resulted in health systems strengthening and improved quality of services.” Consider revising the statement to read: “Integration of leadership and managerial capacity building with CEmONC-specific interventions was associated with health systems strengthening and improved quality of services.” This means replacing the words “has resulted in” with “was associated with.” 4. In material and methods, first paragraph, after the sentence “Five of these received an intervention and two served as controls in order to detect secular trends” include the following: The HCs in the intervention group were Kibati, Ngerengere, Gairo, Melela and St. Joseph HCs. 5. Materials and methods, “The theory of change: a model formulation”: (a) “In order to develop a set of sound and scientifically derived interventions the project applied principles of operations research to identify and address operational factors that determine maternal and newborn health care in Tanzania.” Provide a reference for principles of operational research. (b) “Using evidence-based science on the interventions that work,…” Provide a reference for evidence-based science on the interventions that work. 6. Materials and methods, Strengthening leadership and management, sentence: “The workshops were conducted in 2018 and 2021 and involved participants from 20 primary health facilities, i.e., the 5 intervention health centres and 15 satellite dispensaries,...” Explain the referral relationship between the 5 intervention health centres and 15 satellite dispensaries. 7. Materials and methods, Data collection, sentence: “The BRN tool assesses the following domains: 1) health facility management (12 indicators)…” The indicators are difficult to find in references 17 and 19 cited by the authors. Are you referring to Model of Care Initiative in Nova Scotia (MOCINS) Process Indicators or MOCINS Outcome Indicators contained in reference number 19? To avoid confusion, present the indicators in a table. 8. Materials and methods, Data collection, sentence: “The L&M survey primarily used Likert scales to assess data on care providers’ perceptions on L&M competencies,…” The questionnaire (the questions and the scales) that was used for the assessment should be described in a table. 9. One-way ANOVA and Chi-square tests were used. No p-value was stated in the results. Explain. 10. The term “case fatality rate” may be replaced with “direct obstetric case fatality rate” and defined in the materials and methods section. This will involve replacing “case fatality rate” with “direct obstetric case fatality rate” in the footnote in Table 1. This revision will be in line with the terminology changes in the WHO Monitoring Emergency Obstetric Care – a Handbook (https://apps.who.int/iris/bitstream/handle/10665/44121/9789241547734_eng.pdf?sequence=1). 11. Results, Strengthening health systems, sentences: “Capacity-building strategies in transformational leadership and change management resulted in improved leadership and management as assessed using the BRN star rating assessment system and the survey. Capacity building contributed to improved health facility performance and maternal and child health outcomes.” These are interpretation of the results. Therefore DELETE the sentences. 12. In Figure 2, there are black and orange coloured horizontal lines. Are these confidence intervals. Specify. 13. Results, Strengthening health systems, sentence: “The sub-scales included vision, support, task orientation and role clarity.” Explain how these indicators were improved. Include the accompanying data. 14. Results, Strengthening health systems, sentence: “In 2021, the overall BRN ratings increased in 15 (79%) of the nineteen primary health care facilities,…” This is difficult to understand because in the materials and methods 20 (and not 19) primary health care facilities were mentioned. 15. In Figure 3, what does the dotted line represent? Is it the overall trend in the referral rate in the intervention HCs? 16. Results, Utilization of CEmONC services, sentences: “For instance, the mean monthly deliveries at Gairo and St. Joseph HCs increased from 71 (67 – 76) to 137 (124 - 150) during intervention period, and from 48 (41 – 55) to 129 (116 - 143) respectively. The mean monthly deliveries at Kibati and Ngerengere increased from 21 (18 – 23) to 34 (30 – 37) during intervention period, and from 26 (23 - 28) to 33 (31 – 36) respectively.” Specify the meaning of the numbers in bracket. 17. Results, Quality of CEmONC services: What were the primary causes of the maternal deaths and the avoidable/modifiable factors associated with them (at least in the intervention HCs). 18. Results, The requirements and costs of scaling up of CEmONC services in health centres, sentence: “Detailed findings on the requirements and costs for scaling up CEmONC in health centres in Tanzania are reported elsewhere.” Reference 19 was cited by the authors. However, the word Tanzania could not be found in reference 19 (i.e. Model of Care Initiative in Nova Scotia (MOCINS): Final Evaluation Report). 19. Discussion, Health systems strengthening for maternal and newborn health care, sentence: “Strengthening leadership and management at the health facility district and regional health system levels resulted in strengthened health systems building blocks, which are vital for provision of effective services.” It is preferrable to use the words “was associated with” rather than “resulted in.” 20. Discussion, Scale up of CEmONC services, first paragraph, sentence: Improving the availability and access to comprehensive emergency obstetric and neonatal care services resulted in a marked increase in utilization of services (including women with obstetric complications) and reduced referral rates to distant hospitals in intervention centres. It is preferrable to use the words “was associated with” rather than “resulted in.” This is because the improvements could have been due to other factors such as changes in human migration and population. These may explain some of the outcomes in the control HCs. 21. Discussion, Scale up of CEmONC services, second paragraph, sentence: “Maternal mortality also dropped in the two control centres but they continued to refer pregnancies at the same rate to secondary hospitals, suggesting little change in the complexity of pregnancies and deliveries they were managing.” The data on complexity of the cases managed at the intervention and control HCs were not presented in the result section. 22. Discussion, Scale up of CEmONC services, fourth paragraph, sentence: “Findings from previous and current studies coupled with effective knowledge translation strategies, engagement, political will and commitment resulted in a nation-wide scale up of CEmONC services in public health centres.” Delete “and current.” 23. Discussion, “Addressing the fear of the unknown: the cost of scaling up CEmONC services,” sentence: “The requirements and related costs reported in this study fill the existing vacuum of science and knowledge.” Delete this sentence. This is because the authors also wrote in the results section that “Detailed findings on the requirements and costs for scaling up CEmONC in health centres in Tanzania are reported elsewhere.” Therefore the index report/study can’t be filling any vacuum in knowledge. Additionally, there are previous studies on the cost of scaling up a health facility in low- and middle-income countries. 24. Discussion, Limitations of the study: Acknowledge that other factors such as changes in human migration and population could have affected the findings in both intervention and control HCs. 25. Conclusion: “Integration of leadership and managerial capacity building, with CEmONC-specific interventions has resulted in health systems strengthening and improved quality of services.” It is preferrable to use the words “was associated with” rather than “resulted in.” [Note: HTML markup is below. Please do not edit.] Reviewers' comments: [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0271282.r005
Revision 3
26 Jun 2022 Author Response RESPONSES TO REVIEWER’S COMMENTS 1. Abstract, Result, sentence: “The case fatality rate decreased slightly from 1.5% (95% CI 0.6–3.1) at baseline to 1.1% (95% CI 0.7-1.6) during the intervention period (not statistically significant).” The term “case fatality rate” may be replaced with “direct obstetric case fatality rate” given the definition provided in the footnote in Table 1 and the content of WHO Monitoring Emergency Obstetric Care – a Handbook (https://apps.who.int/iris/bitstream/handle/10665/44121/9789241547734_eng.pdf?sequence=1). Response Thank you. Since there are direct and indirect obstetric causes of maternal deaths, we have replaced the term with “obstetric case fatality rate”. 2. Abstract: State the aim of the study in the abstract. Is this the aim of the study: To detect secular trends in Health Centres (HC) in Morogoro region of Tanzania following the integration of Accessing Safe Deliveries in Tanzania (ASDIT) project with leadership and managerial capacity building in these healthcare facilities? Response The aim of the study was to study how to improve access to comprehensive emergency obstetric and newborn care (CEmONC) in underserved rural areas. This is stated in the last sentence of the introduction section of the abstract, and in the last paragraph on page 3. 3. Abstract, conclusion: “Integration of leadership and managerial capacity building, with CEmONC-specific interventions has resulted in health systems strengthening and improved quality of services.” Consider revising the statement to read: “Integration of leadership and managerial capacity building with CEmONC-specific interventions was associated with health systems strengthening and improved quality of services.” This means replacing the words “has resulted in” with “was associated with.” Response We have replaced the words “has resulted in” with “was associated with.” 4. In material and methods, first paragraph, after the sentence “Five of these received an intervention and two served as controls in order to detect secular trends” include the following: The HCs in the intervention group were Kibati, Ngerengere, Gairo, Melela and St. Joseph HCs. Response Thank you. This sentence has been added in the manuscript. 5. Materials and methods, “The theory of change: a model formulation”: (a) “In order to develop a set of sound and scientifically derived interventions the project applied principles of operations research to identify and address operational factors that determine maternal and newborn health care in Tanzania.” Provide a reference for principles of operational research. (b) “Using evidence-based science on the interventions that work, …” Provide a reference for evidence-based science on the interventions that work. Response Four references have been inserted. 6. Materials and methods, Strengthening leadership and management, sentence: “The workshops were conducted in 2018 and 2021 and involved participants from 20 primary health facilities, i.e., the 5 intervention health centres and 15 satellite dispensaries,...” Explain the referral relationship between the 5 intervention health centres and 15 satellite dispensaries. Response The following sentence has been added; “These dispensaries referred patients with medical complications to the study health centres.” 7. Materials and methods, Data collection, sentence: “The BRN tool assesses the following domains: 1) health facility management (12 indicators)…” The indicators are difficult to find in references 17 and 19 cited by the authors. Are you referring to Model of Care Initiative in Nova Scotia (MOCINS) Process Indicators or MOCINS Outcome Indicators contained in reference number 19? To avoid confusion, present the indicators in a table. Response The domains and indicators are for the Tanzanian Big Results Now assessment tool. These indicators do not refer to Model of Care Initiative in Nova Scotia (MOCINS) Process Indicators or MOCINS Outcome Indicators contained in reference number 19. Since the table with domains and indicators is too long, (Table 1. Big Results Now Star Rating domains and indicators), we have provided it as an additional information to this manuscript … however, the legend has been inserted in the manuscript. 8. Materials and methods, Data collection, sentence: “The L&M survey primarily used Likert scales to assess data on care providers’ perceptions on L&M competencies,…” The questionnaire (the questions and the scales) that was used for the assessment should be described in a table. Response A table has been inserted. Table 2. Leadership and managerial domains assessed in 2018 and 2021 9. One-way ANOVA and Chi-square tests were used. No p-value was stated in the results. Explain. Response Thank you for observation. The confidence interval set to 95% CI for both parametric and non-parametric variables. We have replaced the words “p-value at < 0.05” with “95% CI” in the Methods: data analysis section. 10. The term “case fatality rate” may be replaced with “direct obstetric case fatality rate” and defined in the materials and methods section. This will involve replacing “case fatality rate” with “direct obstetric case fatality rate” in the footnote in Table 1. This revision will be in line with the terminology changes in the WHO Monitoring Emergency Obstetric Care – a Handbook (https://apps.who.int/iris/bitstream/handle/10665/44121/9789241547734_eng.pdf?sequence=1). Response As reported above (comment no. 1), we have revised all places where the term ‘case fatality rate’ appeared. 11. Results, Strengthening health systems, sentences: “Capacity-building strategies in transformational leadership and change management resulted in improved leadership and management as assessed using the BRN star rating assessment system and the survey. Capacity building contributed to improved health facility performance and maternal and child health outcomes.” These are interpretation of the results. Therefore DELETE the sentences. Response The two sentences have been deleted 12. In Figure 2, there are black and orange coloured horizontal lines. Are these confidence intervals. Specify. Response Thank you. We have added in the key (footnote) below the figure that “black and orange coloured horizontal lines are 95% CI”. 13. Results, Strengthening health systems, sentence: “The sub-scales included vision, support, task orientation and role clarity.” Explain how these indicators were improved. Include the accompanying data. Response: Thank you. Instead of presenting data on the team climate subscales we have decided to present data on the L&M overall domains that were assessed in this study, i.e., 1) team climate of facilities; 2) staff role clarity; and 3) job satisfaction. These domains are also presented in table 2. Leadership and managerial domains assessed in 2018 and 2021. 14. Results, Strengthening health systems, sentence: “In 2021, the overall BRN ratings increased in 15 (79%) of the nineteen primary health care facilities,…” This is difficult to understand because in the materials and methods 20 (and not 19) primary health care facilities were mentioned. Response Although capacity building in L&M and all other assessments involved 20 facilities, the 2018 BRN star rating assessment was not done in one HC. We have added a sentence to clarify it in the results – section. 15. In Figure 3, what does the dotted line represent? Is it the overall trend in the referral rate in the intervention HCs? Response The dotted line represented the linear trend in the referral rates in the intervention HCs. However, to avoid confusion, we have removed it. 16. Results, Utilization of CEmONC services, sentences: “For instance, the mean monthly deliveries at Gairo and St. Joseph HCs increased from 71 (67 – 76) to 137 (124 - 150) during intervention period, and from 48 (41 – 55) to 129 (116 - 143) respectively. The mean monthly deliveries at Kibati and Ngerengere increased from 21 (18 – 23) to 34 (30 – 37) during intervention period, and from 26 (23 - 28) to 33 (31 – 36) respectively.” Specify the meaning of the numbers in bracket. Response The numbers in the brackets signify 95% CI. These have been added in the manuscript. 17. Results, Quality of CEmONC services: What were the primary causes of the maternal deaths and the avoidable/modifiable factors associated with them (at least in the intervention HCs). Response We have added the following sentences in the manuscript. “During these periods (baseline and during the intervention) 40 maternal deaths occurred. The primary causes of these deaths during the intervention period were postpartum haemorrhage 8, pre/ eclampsia 5, puerperal sepsis 3, complications of anaesthesia 2, uterine rupture 2, severe anaemia in pregnancy 2 and antepartum haemorrhage 1. The causes of deaths were not established in 13 maternal deaths that occurred at baseline, and four that occurred during the intervention in the control HCs because of inadequate records keeping. Avoidable factors were determined in only 87% i.e., 20 cases out of 23 deaths because the case files for the other 3 had inadequate information. Delay to provide appropriate care after reaching the facilities was identified in 80% i.e., 16 of 20 facilities. A delay in seeking treatment/ reaching the facility was found in 55% i.e., 11 out of 20 deaths.” 18. Results, The requirements and costs of scaling up of CEmONC services in health centres, sentence: “Detailed findings on the requirements and costs for scaling up CEmONC in health centres in Tanzania are reported elsewhere.” Reference 19 was cited by the authors. However, the word Tanzania could not be found in reference 19 (i.e. Model of Care Initiative in Nova Scotia (MOCINS): Final Evaluation Report). Response We have replaced the reference with the appropriate one. 19. Discussion, Health systems strengthening for maternal and newborn health care, sentence: “Strengthening leadership and management at the health facility district and regional health system levels resulted in strengthened health systems building blocks, which are vital for provision of effective services.” It is preferrable to use the words “was associated with” rather than “resulted in.” Response Replacement done. Thank you 20. Discussion, Scale up of CEmONC services, first paragraph, sentence: Improving the availability and access to comprehensive emergency obstetric and neonatal care services resulted in a marked increase in utilization of services (including women with obstetric complications) and reduced referral rates to distant hospitals in intervention centres. It is preferrable to use the words “was associated with” rather than “resulted in.” This is because the improvements could have been due to other factors such as changes in human migration and population. These may explain some of the outcomes in the control HCs. Response Replacement done. Thank you 21. Discussion, Scale up of CEmONC services, second paragraph, sentence: “Maternal mortality also dropped in the two control centres but they continued to refer pregnancies at the same rate to secondary hospitals, suggesting little change in the complexity of pregnancies and deliveries they were managing.” The data on complexity of the cases managed at the intervention and control HCs were not presented in the result section. Response Thank you. By saying the complexity of pregnancies and deliveries the authors meant complicated pregnancies managed at the health facilities. In the results in table 3, the authors presented a summary of women who had obstetric complications (maternal morbidities) at baseline and during the intervention period. In the Results, Utilization of CEmONC services (sub-section): we also presented figures of women with obstetric complications referred to the nearby district hospital. We thought that the data on maternal morbidities and referred pregnant women provided a snapshot of complexity of pregnancies and that somehow justify our statement. 22. Discussion, Scale up of CEmONC services, fourth paragraph, sentence: “Findings from previous and current studies coupled with effective knowledge translation strategies, engagement, political will and commitment resulted in a nation-wide scale up of CEmONC services in public health centres.” Delete “and current.” Response The words are deleted 23. Discussion, “Addressing the fear of the unknown: the cost of scaling up CEmONC services,” sentence: “The requirements and related costs reported in this study fill the existing vacuum of science and knowledge.” Delete this sentence. This is because the authors also wrote in the results section that “Detailed findings on the requirements and costs for scaling up CEmONC in health centres in Tanzania are reported elsewhere.” Therefore the index report/study can’t be filling any vacuum in knowledge. Additionally, there are previous studies on the cost of scaling up a health facility in low- and middle-income countries. Response The sentence is deleted 24. Discussion, Limitations of the study: Acknowledge that other factors such as changes in human migration and population could have affected the findings in both intervention and control HCs. Response Thank you. These factors have been added in the list of limitations 25. Conclusion: “Integration of leadership and managerial capacity building, with CEmONC-specific interventions has resulted in health systems strengthening and improved quality of services.” It is preferrable to use the words “was associated with” rather than “resulted in.” Response The words are replaced. Thank you Attachments Attachment Submitted filename: Responses to reviewers comments.docx https://doi.org/10.1371/journal.pone.0271282.r006
28 Jun 2022 Decision Letter - Nnabuike Chibuoke Ngene, Editor Scale up and strengthening of comprehensive emergency obstetric and newborn care in Tanzania PONE-D-21-37381R3 Dear Dr. Nyamtema, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Nnabuike Chibuoke Ngene, Dip HIV Med; MMed(FamMed); FCOG; MMed(O&G); Ph.D Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0271282.r007
Formally Accepted
1 Jul 2022 Acceptance Letter - Nnabuike Chibuoke Ngene, Editor PONE-D-21-37381R3 Scale up and strengthening of comprehensive emergency obstetric and newborn care in Tanzania Dear Dr. Nyamtema: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Nnabuike Chibuoke Ngene Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0271282.r008

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