https://orcid.org/0000-0003-3008-8616
Peer Review History
| Original SubmissionJune 19, 2020 |
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PONE-D-20-18867 Lessons from an implementation research on community management of possible serious bacterial infection (PSBI) in young infants (0-59 days), when referral is not feasible in Palwal district of Haryana, India. PLOS ONE Dear Dr. Arora, 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. There are extensive suggestions that must be faced to correct defects and make the manuscript to improve. Please report each change with the correction you´ve done in a document. An English revision is also necessary. Please submit your revised manuscript by Sep 28 2020 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:
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Please add a citation to support this phrase or upload the data that corresponds with these findings to a stable repository (such as Figshare or Dryad) and provide and URLs, DOIs, or accession numbers that may be used to access these data. Or, if the data are not a core part of the research being presented in your study, we ask that you remove the phrase that refers to these data. [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: Yes Reviewer #2: Yes ********** 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: Reviewer’s comments The Introduction is concise and focused. Methodology The authors describe some of the health indicators like Neonatal Mortality Rate and Infant Mortality Rate (lines 111-114). However it is not clear if these indicators are specific to the study area or are national rates. If these are specific to the study area then each indicator should be compared to the national rates. This study to a large extent exposes the health care seeking behavior of the community. The authors should present some of the relevant health care seeking indicators of the study setting. In addition to mentioning the number of health facility deliveries they should provide the proportion of home deliveries or deliveries assisted by health personnel. Also, other health seeking behaviors like proportion of the population who self-medicate or use other community management (including use of traditional methods) should be stated. Study settings: The authors give a general description of the health facility structure but do not give the exact staffing and other resources in the study district. They need to describe the staffing levels in the different levels of health care and other facilities for management of the newborn. Study design: In Line 137 the authors have not described the implementation research model used in the study. This information is very important for implementation research. The authors should clearly state the implementation research principle and design that was used in the study. Did they apply any framework? Line 154-155: This sentence may not be included. The authors should avoid such casual statements as it puts questions on the criteria for selection of the study team. Formative research: Lines 179-181: Some of the methods used in the formative research are not scientifically rigorous, e.g. the use of non-formal interaction with health care personnel would not give the most valid results. They could have used standard methods like Key Informant Interviews. In lines 181-184: the authors do not state the data collection methods used in baseline assessments of some of the factors; e.g. Exploration of the attitude and confidence of health providers in managing sick young infants; Existing gaps in reporting and monitoring HBNC related indicators; Quality and frequency of home visitations, etc. Without this information it is difficult to verify the reliability of the data. Lines 196-200: Were standardized observation checklists used? The authors should specify which data collection methods or data collection tools were used to obtain the data. They should differentiate between the methods used for quantitative and qualitative data collection. The data analysis section is not described in detail. This study has a large component of qualitative data. The authors should describe in detail how the data from the various qualitative methods were analyzed and represented. The analysis of the different quantitative data, similarly, should be clearly described. Discussion Lines 396-401: The authors should explore and clearly indicate the possible reasons for poor performance of the ANMs and ASHA since their study had extensive qualitative aspects. They need to discuss the limitations these personnel are facing e.g. what hinders them from being confident in treating the newborns; why would the ASHAs have incomplete data; could it be a lack of training? Is it poor motivation from working conditions? These issues need to come out clearly. The authors are in a better position to give recommendations on how to enhance the performance of these personnel. Line 428-431: The mortality rate in this study is impressively low. This is very important data from this study, and the authors ought to magnify this information. The authors should discuss how the NMR in their study compares with the national rates and explain the reasons for the low mortality rate. These may form their stem for major recommendations. 432-442: The authors do not have much evidence to discuss the private health facilities. However they can expound on the effects their interventions had on the services in the public health facilities and the increased utilization. In the section on limitations, the authors should discuss each limitation stating the effects it had on the findings in their study. The authors should calculate and reflect the cost estimate for the implementation of the interventions in order to shed light on feasibility of sustainability of the program. Conclusion section (461-469): The conclusions of the study are not well aligned to the objectives. The authors should review this section and align the objectives (lines 93-100) to the conclusion. The authors are advised to avoid the use of abbreviations in the conclusion, except for those globally recognized. Writing style; linguistic expression The authors should use italics only when necessary. Lines 191-194: Improve the English sentence construction. Lines 237-241: Improve sentence construction and grammar. Use appropriate punctuation marks. Lines 253-254; Review the sentence. Lines 443; improve on the sentence construction. Reviewer #2: This an interesting and potentially very useful formative evaluation of an effort to implement guidelines for community management of PSBI in young infants as a treatment option when referral is not possible in the Palwal district of Haryana, India. The implementation effort was multi-phased and appears to have shown some significant and important results with respect to feasibility of implementation; the paper also highlights some important “lessons learned” from the experience which may be beneficial for scaling out similar types of interventions and preventing further infant mortality. The potential contributions of the paper in its current form, however, are undermined by (1) a lack of clarity in describing the implementation and evaluation processes as distinct processes (where possible) or overlapping entities (when applicable); (2) informed descriptions of the methods, with scientific (or pragmatic) justifications for decisions made; (3) lack of boundaries between description of methods and reporting of results; (4) presentation of results that is very difficult to follow and does not focus on key findings relating to the purview of the research, as an observational, pragmatic study of feasibility of implementing guidelines in these type of communities; and (5) a lack of recognition of the limitations of the study, particularly when it comes to questions around, e.g., establishing the “effectiveness” of a drug relative to questions about implementation feasibility. The following comments highlight changes recommended prior to this paper’s acceptance for publication. Background • This section is quite short & missing some key information—notably, while the authors note that referral for admission to hospitals in areas like the one under study are challenging, they don’t describe any of the barriers. This is crucial background for understanding why an alternative process like the guideline implementation being studied is a preferable alternative to simply addressing those barriers to better referral. • The authors should also add in some additional detail about the PSBI problem—e..g., what are the current mortality rates in India from PSBI, what fraction of infant mortality could be prevented with better treatment for PSBI, and how much would mortality rates be expected to decline if GOI/WHO guidelines were followed? • The authors also need to include information (somewhere—here if documented in prior research/reports) what the known bottlenecks/barriers to implementing these guidelines are (e.g., the cited “paucity of operational and contextual barriers”)—what were these barriers and how did they inform the current research project? • The objectives as currently written are difficult to follow and do not clearly align with an implementation evaluation or understanding of current barriers—I would strongly encourage the authors to make these objectives more concrete and then use these objectives to organize the methods (both implementation and evaluation methods) and results reporting. As an example, for objective 1, it is unclear what the authors are referring to when they say they are “strengthening the existing health system for early identification”—does that mean they are assessing barriers, or adding new resources, or …? Similarly, with objective 2—what is meant by “prepare primary care facilities”? What sort of preparation or implementation support is being provided? and how does this differ with objective 3, where the PSBI program is “embedded”? Without clarity as to the concrete aims of these objective in terms of both the program implementation and evaluation, it is very difficult to evaluate whether or not the implementation effort and evaluation went according to plan or—more importantly—whether the feasibility identified would be translatable to other similar settings. Methodology • Study population: Some additional information on the “aspirational” aspect of the Palwal district would be appreciated to understand potential generalizability, namely how do the birth and mortality rates compare to those across India? Additionally, the authors never note or justify why this district was chosen for this work & how this might relate to the generalizability of the findings—for example, is this a case of “if it doesn’t work here, it likely won’t work in other districts” because barriers should be lower here? • Health infrastructure: Would encourage structuring the table currently labeled as Panel 1 in a way that makes it easier to follow and compare across settings—for example, having columns indicating type of provider present, type of care provided, maybe the total population it serves and/or number present in the area studied (the latter of which was not information I saw in the current format). This presentation would help to highlight key differences, especially as they relate to big questions regarding access undergirding this project. • Study design: o Section should specify which implementation research principles were used and justify the selection o Generally, this section, the steps/methods used & how they map onto the objectives was difficult to follow. Would strongly suggest including a diagram or figure that maps both the steps of the process and the pieces of the formative evaluation onto the overall study objectives. o Details about the study protocols—especially for interviews, surveys, etc—are almost completely absent. Protocols for each of these data collection efforts should be (at least briefly) described, in a table or elsewhere. Also, this section consistently conflates research methods with results—for example, reporting final Ns for data collection instruments, rather than study protocols and procedures for recruiting individuals to complete measures, instruments, or interviews. o Policy dialogue: Panel 2 is interesting and clearly very important, but no context is given for why certain departures from the WHO guidelines were determined and/or how they were justified. This is very important to understand as implementation efforts assume implementation of an evidence-based practice; if these guidelines are forcing departure from that evidence-base, it undermines the entire endeavor. Alternatively, tailoring that is done to address known barriers is an important part of the implementation process and thus provision of details about why these changes were made should be provided. o Implementation phase: Specifics on the implementation strategy used should be provided ideally in line with Proctor, Powell & McMillen (2013) and/or as specified through the ERIC classification of implementation strategies (cf. Powell et al, 2015). o Table 1: This table is clearly both very important and also incredibly onerous and almost entirely ineffective at communicating information. Additionally, the information included here seems to be related to results, not methods—so it should be moved, and the results should be presented in a more reader-accessible and organized way. One option may be to keep this table as supplemental information and highlight key results (in the results section!) that are curated by the authors as highlighting key lessons learned. o Nudges: No rationale or justification is provided for using the nudge strategy—which is notable because evidence regarding the effectiveness of nudges in changing behaviors is mixed. Additionally, it is not clear where or at what stages nudges were developed, how they were integrated into the overall implementation strategy, what protocol for nudges were & whether these protocols were followed with fidelity, and/or what results they were expected to have. Finally, no citations are provided for definitions of or literature around behavioral nudges. o Data collection/management: Again, results are presented here. No Ns should be presented in methods sections (other than population N or target Ns). • Results o As with the methods section, it is difficult to follow which results track from which stages of the process. I would again encourage picking a structure for presenting the overall study design (e.g., in phases), mapping the objectives/research questions to those phases, and then mapping results (in this section) to those phases/questions. As presented currently, the conflation of methods for evaluation and results of those evaluations are very convoluted and difficult to extricate to determine whether results are valid or reliable, or whether they answer questions of interest. o Table 2: Unclear whether the days listed in Column 1 are ranges (e.g., is the second line reflecting visits that occurred between Day 1 and Day 3 or just on Day 3)? Also unclear why 0 visits is inapplicable to the partial information category. Finally, I didn’t see the response rate indicated anywhere in the table or text—is it correct that the response rate is (2001+487)/16,997 total calls, i.e., less than 15%? o Table 3: The presentation of this table (as well as some of the text in the conclusion) suggests that there were some over-time improvements in implementation, however these effects are not apparent from this table—perhaps because there is so much information that is presented here? One suggestion would be to curate this table a bit more to focus on the results that were most interesting? For example, since sub-centres were never the first point of care nor place of treatment, these rows could be removed from the table & a footnote could indicate this absence of action. Additionally, if changes over time are of interest, proper statistical tests should be included. (Note that a multi-paneled figure reflecting trends would be a much more reader-friendly way to convey this information as well). o PSBI management: � Unclear where the 10% live births with PSBI assumption comes from; this should be justified and sources referenced. � Table 4: Best practices in this table should be highlighted to indicate what proportion of cases were ‘high fidelity’. Additionally, having a separate category for 6 cases (Critical illness) is problematic—would combine with one of the other categories (or simply not include as its own column). I also don’t think sections B1 and B2 need to be in the table since they are not a focus of the implementation effort. Discuss in the text but exclude from the table. � Unclear what the purpose of is including section on sicknesses identified other than PSBI—this should be dropped, and other relevant information related to barriers to care should be expanded. • Discussion: o Unclear where the 70% treatment coverage rate came from—this should be defined precisely in the results section. o Generally, conclusions need to be tempered for this paper, and the conclusions should remind the readers from the outset that this was an observational, feasibility study for implementation of a particular guideline. While this paper does seem to strongly support feasibility of this intervention, there are serious limitations related to the selection of the region, problems with data reporting, and of course the study design that limit generalizability of findings, and certainly limit any notions of effectiveness or causality of the implementation. This is particularly notable for the authors claim that this study “demonstrated that oral amoxicillin alone is effective in managing pneumonia cases”—such a claim simply cannot be made with a study like this as there is no control case; data is purely observational. Further, claims like this distract from the implementation focus of the study. The authors would be much better off focusing on the purview suggested by the title—lessons from implementation—rather than trying to make claims related to clinical effectiveness. Of course, this doesn’t mean that they cannot claim that low mortality rates and high treatment rates aren’t important; they are—but they are reflective of the potential for guidelines like this to be implemented in communities like this that have room for improvement; their “effect” on downstream clinical outcomes simply cannot be estimated without a more rigorous study design. o As with the rest of the manuscript, the conclusion has several places where important references appear to be missing—e.g., for “recent implementation research” that describes adherence to antibiotics guidelines improving slowly over time. o The limitations should reflect the limitations of the observational study design, potential threats to validity and generalizability related to the population of interest, and larger issues related to data quality and potential missing data. This section is very weak at the moment. ********** 6. 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| Revision 1 |
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Lessons from an implementation research on community management of possible serious bacterial infection (PSBI) in young infants (0-59 days), when referral is not feasible in Palwal district of Haryana, India. PONE-D-20-18867R1 Dear Dr. Arora, 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, Ricardo Q. Gurgel, PhD Academic Editor PLOS ONE Additional Editor Comments (optional): 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: All comments have been addressed Reviewer #3: (No Response) Reviewer #4: (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: Partly Reviewer #3: Yes Reviewer #4: Partly ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #3: Yes Reviewer #4: 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: Yes Reviewer #4: Yes ********** 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 Reviewer #4: 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: (No Response) Reviewer #3: This is an important paper relates to WHO guideline on implementation of management of possible severe bacterial infection in low-middle income countries that has critical importance for global public health and findings of the study could affect policy and practice in other settings. It is professionally written paper. I do not have major reservations. However, the paper needs minor revision on the following issues before it can be considered for publication. Please delete lines 247-252 “out of family…………………… S1 table” from method section and author may describe it is result section. Table 2 can be deleted and replace in brief narration. Please revise Table 1 as it is too lengthy. It would be rendered concise and comprehensive for the ease of readers. There is some repetition in the paper. Please delete lines 303-307 “there were two …………………………………………………… in the CHCs and PHCs (Table 1)”. As it is repetition, already documented in table 1. Please delete line 316-325 “Implementation of nudge strategies” section as it is repetition. Reviewer #4: 1. This research should be viewed in the context of a series of studies conducted in different geographical locations in India that have been published in your journal, PLOS ONE. This is a part of the implementation research on WHO PSBI guidelines. 2. The objective of the study is to implement the PSBI guideline developed by the WHO & GOI 3. The RE- AIM Framework was adopted to document the implementation strategy. 4. Chance of working in a real world setting, strength and weaknesses of different approaches have been tested using the Reach, Effectiveness, Adoption, Implementation & Maintenance approaches that are together expected to determine the Public Health Impact of the intervention. 5. Considering the above, the individual level impact in terms of reaching the target population and efficacy of the intervention have been achieved in good measure in the study ( 70% coverage and above 90% achievement of clinical treatment success). However, a higher Coverage of intervention (80%) was achieved in Himachal Pradesh (Goyal et al). Identification of PSBI by ASHA workers was reported to be 80% in the study by Awasthi et al in Uttar Pradesh. As members of this collaborative research team, the authors of the manuscript could have used learnings from these settings to improve the implementation in Palwal. 6. One can not comment on the consistency and the cost of intervention implementation, as it has not been evaluated or reported in the manuscript. 7. Maintenance of the intervention effects in the study setting was probably not possible to observe, as the authors report termination of the study without executing the planned exit strategy, under limitations. 8. The TSU served as the backbone in the implementation research study: although the strategies to empower mothers and families, building capacity through training of health staff seems to be partially successful, the strategy for improving performance of the ASHAs, ANMs seems to have failed. It is mentioned that the health system laid emphasis on the registration /line listing of the beneficiaries by the ASHAs, however, completing the visitation as per schedule of HBNC was not prioritised. The authors have not explained any reasons for this. It is mentioned that Non formal interactions with health care providers were conducted to explore these issues in a restrained manner. However, better remedial measures if implemented under the guidance of the TSU/ or on the basis of feedback from the research team that co-participated in the implementation for initial six months to identify barriers, could have led to improved coverage of HBNC visits by ASHA resulting in better identification of PSBI as well. Learnings from the efficacy trials such as the Gadchiroli study (Bang et al The Lancet 1999) and more recently results of an M-health intervention study conducted in Gujarat (Modi et al PLOS One- 2019) indicate that Village health workers now called ASHAs, if trained adequately can help improve the morbidity mortality indicators immensely. 9. The qualitative research has been designed and implemented well. Community mobilization activities have been described well. 10. Data presented in Table 2 describes identification, point of care, place of treatment, number of deaths by six Quarters, however, no trends can be observed in the data presented. It is not helpful in understanding the impact of study activities on outcomes. 11. Table 3 Post natal Home visitation by ASHAs shows substantial discrepancy in data reported by ASHA and the data collected by the research team on phone calls: The reasons for this should have been better discussed, it is just mentioned that incomplete data on mother-infant dyad was not reported. 12. The ASHAs identified only one tenth of the PSBI cases: was the incentive based payment system working adequately in the study setting? could there be monetary reasons for underperformance among others, listed by the authors in the discussion section.? 13. Similarly, what were the reasons for better impact on mothers and family members as compared to ASHAs and other health workers? 14.The Implementation research study identified the bottlenecks of implementation of PBSI guideline in presence of a TSU and its positive role, well emphasised in the manuscript. The reasons for failure of its strategies to improve service delivery by ASHAs, ANMs needs to be further explored ********** 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: Prof Sajid Soofi Reviewer #4: Yes: Anju Sinha |
| Formally Accepted |
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PONE-D-20-18867R1 Lessons from implementation research on community management of possible serious bacterial infection (PSBI) in young infants (0-59 days), when the referral is not feasible in Palwal district of Haryana, India. Dear Dr. Arora: 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 Professor Ricardo Q. Gurgel Academic Editor PLOS ONE |
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