Evaluation of the community-based outpatient therapeutic feeding program implementation for managing children with severe acute malnutrition in Northwest Ethiopia: A mixed-method evaluation protocol.

BACKGROUND: Community-based outpatient therapeutic feeding program (C-OTP) in Ethiopia has been launched to manage uncomplicated severe acute malnutrition (SAM) by trained Health Extension Workers (HEWs). This program is believed to be the most effective strategy for reaching a large group of children suffering from SAM in rural and disadvantaged communities. Nonetheless, poor treatment outcomes, notably mortality and prolonged recovery time, become pressing public health problems, which could be a result of suboptimal implementation and poor service quality.
OBJECTIVES: To evaluate the implementation of C-OTP for managing uncomplicated severe acute malnutrition in the Central Gondar Zone.
METHODS: Multiple studies involving both qualitative and quantitative will be conducted. Availability of essential drugs and equipment, acceptability of the program by mothers/caregivers, health extension workers' compliance to the treatment protocol, and treatment outcome will be assessed employing different methods. Likewise, knowledge of health extension workers about SAM diagnosis and management and their skills to diagnose and manage uncomplicated malnutrition will be determined. Health extension workers, mothers/caregivers, supervisors, and healthcare administrators will be enrolled in the study. Besides, children's medical records registered between 2017 and 2020 will be reviewed to determine the treatment outcome. The data will be collected using pretested self-administered and face-to-face interviewer-administered questionnaires. Similarly, focus group discussions (FGDs), in-depth interviews, and observation checklists will be applied. Binary logistic regression analysis will be conducted, while the qualitative data will be analyzed using thematic content analysis. DISCUSSION: Severe acute malnutrition is a public health problem that remains the underlying cause for over half of under-five mortality in Ethiopia. As a result, community-based therapeutic care has been launched in the country to address these problems and maximize population-level impact by improving treatment coverage, access, and cost-effectiveness. Despite its achievement, the program has been threatened with unfavourable treatment outcomes and a shortfall of resources. Hence, this implementation evaluation study will also identify gaps between healthcare systems and service users. The output will help programmers pass evidence-based and sound decisions to tackle the key barriers.

Introduction

Globally, malnutrition results in 3.1 million child deaths annually, accounting for 45% of all under-five mortality [1]. Severe acute malnutrition (SAM), in particular, is the most devastating and life-threatening form of malnutrition, with a 20–30% case fatality rate. The prevalence of wasting in Ethiopia is 7% [2]. In cognizance of the extent of the problem, Ethiopia has launched a community-based outpatient therapeutic program (C-OTP) to manage uncomplicated SAM by trained HEWs. The program was formulated with core operating principles such as maximum population coverage and access, timeliness, appropriate care, and care for as long as needed [3]. The community-based approach is home-based management of SAM that enables timely detection of malnutrition and is provided for those without medical complications using ready-to-use therapeutic feeding (RUTF) or other homemade nutrient-dense diets [4]. The program has multiple indicators from input to impact that could be evaluated using various evaluation dimensions and model indicators.

Nearly three-quarters of the children diagnosed with SAM are uncomplicated (the majority have a good appetite for RUTF/diets and do not have co-morbidities) and can be managed in the outpatient program. Despite this, the caseload is still concentrated in secondary and tertiary level health facilities, making it challenging to provide appropriate service [5].

The traditional in-patient care model of therapeutic feeding centres (TFC) could not effectively respond to large-scale humanitarian crises, as poor access was the prime obstacle [6]. Parallel to this, the in-patient management approach could be the underlying cause for delay in receiving treatment which could further lead to multiple long and short-term complications, including but not limited to heart failure and marked immunosuppression resulting in infectious diseases [1, 7]. It is, therefore, vital to deliver C-OTP that is integrated with a facility-based approach and implemented on a large scale with competent HEWs [1, 8].

There is controversial evidence on the effectiveness of the C-OTP [9-11]. On the one hand, C-OTP has declared a more feasible approach in that the mean cost per treated child was reduced by more than half (134.8$ versus 284.6$) [10, 12]. On the other hand, the death rate in C-OTP was 1.2%, while it is zero in the TFC [10]. Likewise, 4 out of 10 children with SAM remained severely malnourished at discharge after undergoing the recommended management and length of stay in outpatient management [8, 13]. Further, a report in Ethiopia highlighted that the recovery rate among children with SAM admitted to C-OTP was 45%, with an average weight gain of 5–6 g/kg/day, which is far below the recommended weight gain from the program [11]. However, the community-based approach provides care at an affordable cost where the cost-effectiveness of emergency community-based therapeutic programs varies from US$12 to US$132 per year of life gained [3].

Despite the sizable impact of the C-OTP on reducing cost, addressing a large group of the child population, decreasing the chance of contracting illness due to extended hospital stay, and having an enabling environment to implement it, some evidence indicated the possible limitations [1, 8, 14]. More significant than expected poor treatment outcomes and longer recovery time in this model of care than in inpatient care might be related to its poor implementation.

Therefore, this study will evaluate the implementation of the C-OTP in the central Gondar zone. Assessing the program’s performance, key programmatic variables, and clinical outcomes is pivotal in bringing strategies to end childhood death and associated long-term sequelae due to SAM.

To what extent are HEWs knowledgeable about SAM diagnosis and management principles and capable of diagnosing and managing uncomplicated SAM?

Do the HEWs adhere to the C-OTP management guideline?

Do mothers/caregivers of children with SAM accept the C-OTP?

What are the barriers and enablers for the observed level of C-OTP implementation?

To assess the skills of HEWs on case identification and management of uncomplicated SAM.

To determine the knowledge of HEWs about SAM.

To measure the compliance of HEWs to the C-OTP protocol.

To explore the mother’s/caregiver’s acceptability of C-OTP of the service.

To explore the barriers and enablers to the observed level of integrated community-based outpatient therapeutic program implementation for SAM.

To determine the treatment outcome of severely malnourished children who received treatment under the C-OTP.

Evaluation methods

Evaluation design and settings

Multiple case studies with mixed-method evaluation will be used to evaluate the C-OTP implementation from the 15th of September to the 30th of December 2021 in the Central Gondar Zone, Amhara Region. The zone is situated 727 km away from Addis Ababa, the country’s capital. There are 11 districts and 880 HEWs in the region. A minimum of two and a maximum of three HEWs are deployed in each health post.

Amhara regional state is an impoverished region among all areas in the country that is threatened by the high burden of food insecurity and malnutrition. Multiple strategies, including C-OTP, have been applied to address malnutrition and prevent its associated morbid and fatal complications. The program launched nationally in 2007, with HEWs to support and manage children with SAM having no medical complications by administering medicines and therapeutic food. HEWs should conduct periodic community screening and manage cases based on severity. Severely malnourished children without medical complications are eligible to enrol in the program. They receive RUTF and antibiotics (regardless of clinical presentations). During each visit, HEWs assess patient’s progress weekly and follow them until they fulfil the discharge criteria. HEWs counsel mothers/caregivers about feeding and other healthy behavior practices to optimize the treatment outcome.

According to the treatment guideline, HEWs’ are required to refer children with medical complications to the nearby stabilization center to receive in-patient care, as they may need parenteral medications, nasogastric feedings, and close follow-up. Once children are free from medical complications, clinicians discharge them from in-patient care and link them to the C-OTP.

Study participants and reporting procedure

All children aged 6–59 months with uncomplicated SAM enrolled in C-OTP, mothers/caregivers, HEWs, program officers, and health extension supervisors will be involved. The OTP follow-up records and reports available in each health post will be considered.

The finding of the study will be reported using different reporting guidelines for each study design/approach employed. Accordingly, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and COREQ (Consolidated Criteria for reporting qualitative research) writing checklists for the cross-sectional and qualitative analyses, respectively, will be used [15, 16].

Sample size and sampling procedures

A total of three districts will be included. The number of participants recruited will be determined by each objective of the study. All HEWs available in the three selected districts will be included to assess their knowledge and diagnosis skill. Similarly, mothers/caregivers whose children completed the treatment within the last six months will be invited and enrolled to determine the service’s acceptability. All HEWs in the three districts and health posts will also be included in assessing the compliance and availability dimensions. Further, all children enrolled in the treatment centers between 2017 and 2020 will be included to determine the treatment outcome (death, transferred out, failure to respond, default, and cured/survived). Medical recording charts with incomplete records for outcome variables will be excluded.

A case study and descriptive qualitative study will be conducted. All health posts in the three districts will be considered as cases to identify the program’s facility-related barriers and enablers. Moreover, the purposive sampling technique will be applied to approach the study participants. The participants will be recruited considering different criteria, including their experience in the given position, active engagement in the program, and caseload (participants from the lowest and highest case flows). In-depth interviews with HEWs, key informants’ interviews with program managers (nutrition officers and HEWs supervisors) at the district level, and focus group discussions (FGDs) with mothers/caregivers will be conducted until the level of data saturation reaches. The data saturation will be determined during data collection and analysis. The interviewers will stop collecting data when new information is no longer generated from the interviewee [17]. In addition, the data will be transcribed and analyzed parallelly with the data collection, and data collectors will quit when new themes/codes are not produced.

Evaluation dimensions and variables

Availability and acceptability dimensions from the access framework and the compliance dimension from the implementation fidelity framework will be used to evaluate the program implementation [18-20]. The dependent variables will be compliance to the protocol, HEW’s knowledge, case identification and management capacity of the HEWs, SAM treatment outcome (transferred out, default, death, and cured/recovered), mothers/caregivers program acceptability, and barriers as well as enablers of the program. A list of independent variables will be selected per the individual to community-level dimensions. These variables are the sociodemographic, economic, and cultural characteristics of mothers/caregivers.

Availability

The physical availability and functionality of essential equipment needed for the program implementation [20]. The data will be gathered using resource inventory checklists comprising of 14-items (Table 1). If all essential equipment required to provide the care like Plumpy’nut, medications, Mid Upper Arm Circumference (MUAC) tape, and wall charts, are available and functioning well, it will be stated as ‘fully available’ otherwise ‘not fully available.’

Table 1

Summary of the dimensions/variables of implementation evaluation of C-OTP and measurements in Central Gondar zone, Ethiopia, 2021.

Framework	Dimensions/variables	Measurement items	Data collection technique
Access [18, 20]	Availability	Checking for the treatment protocol Checking for essential drugs and medicines Checking for anthropometry measuring devices	Observation checklists
	Acceptability	Approach with HEW The RUTF safety to children Distance from the health post Transportation access	Face-to-face interview
Implementation fidelity [23]	HEW’s knowledge of SAM	Diagnosis of SAM Management of SAM	Self-administered questionnaire
	HEWs diagnostic and treatment capacity	Diagnosis of SAM Management of SAM	Observational
	Compliance/adherence of HEWs with the treatment protocol	Does the HEW document all the findings? Does the HEW give medicines and RUTF as per the guideline? Does the HEW record the anthropometry measurements? Does the HEW admit children based on the protocol?	Chart review
Treatment outcomes	Died	Evidence recorded on the OTP card	Chart review
	Recovered	Evidence recorded on the OTP card	Chart review
	Defaulter	Evidence recorded on the OTP card	Chart review
	Transferred out	Evidence recorded on the OTP card	Chart review
	Dropout	Evidence recorded on the OTP card	Chart review

Acceptability

Mothers’/caregivers’ acceptance (satisfaction) about the service provided [20]. It will be measured using 14-item questions with five-point Likert scale responses ranging from ‘strongly agree’ to ‘strongly disagree’ (Table 1). The individual scores will be summed up. Acceptability will be defined as ‘good acceptance’ if a participant responds to ≥75% of the total number of questions (53) ‘agree/strongly agree’ (for positively coded questions) and ‘disagree/strongly disagree’ (for negatively coded questions); otherwise, ‘poor acceptance.’

Compliance/Adherence

The adherence of HEWs to the treatment guideline will be measured by patient-provider interaction observations and document reviews using the 11-item checklists. The questions will assess both the diagnosis and treatment adherence of the HEWs. The responses will be categorized as ‘good compliance’ if all questions are addressed and ‘poor adherence’ if one of the eleven questions is missed.

Transferred-out: if the child’s condition has deteriorated and referred to a stabilization center for better treatment [21].

Cured: a child fulfils the discharge criteria, namely MUAC≥11.5cm, no oedema, and weight-for-height >-2SD [21].

Defaulter: a child absent for two consecutive visits [21].

Died: a child dies when receiving treatment in the C-OTP [21].

Failed to respond: a child doesn’t reach the discharge criteria for SAM after 16 weeks of treatment [21].

SAM treatment outcomes

Uncomplicated SAM

Children 6–59 months old whose weight-for-height/length below 70% or below -3z score of the World Health Organization (WHO) standards and bilateral pitting oedema and/or MUAC <11.5cm (age older than six months) and have no other medical complications like pneumonia and anemia [21, 22].

Diagnosis and management skill

The HEWs’ will be deemed as ‘skilful’ in diagnosing and managing uncomplicated SAM if they assess, classify, and manage the child appropriately per the treatment guideline. An observational checklist will be used to evaluate the performance of each HEW. Their skills will be judged and determined by trained general practitioners/experienced paediatrics nurse specialists.

Knowledge about uncomplicated SAM and management

A pretested structured questionnaire will be administered, and then HEW’s knowledge score will be categorized as per the estimate of the principal component analysis (PCA).

Data collection tools, procedures, and quality assurance

Multiple data collection techniques and tools will be used. A face-to-face interviewer-based validated questionnaire will be used to assess the mothers/caregivers’ acceptability of the service. Mothers/caregivers whose children have received the care each health post in the previous six months of the survey will be tracked by the respective HEWs and included in the study. A self-administered questionnaire (to assess the knowledge of HEWs), structured observation (for adherence, diagnosis skill, and availability), and document/chart review (for treatment outcome) checklists will be employed. Similarly, a semi-structured interview guide for the in-depth interview, key informants’ interview, and focus group discussion (FGD) will prepared and used. Further, field notes during observation will be taken. Independent tools comprising various indicators to assess the availability and supply of essential equipment for the program and HEWs compliance with the treatment guideline will also be used.

An observational checklist will be employed to assess the HEW’s case identification and management skill. Accordingly, trained general practitioners will verify the accuracy of the HEWs’ anthropometrics measurement, diagnosis, treatment performance, and treatment plan. Moreover, the knowledge of HEWs about SAM will be examined using a pretested self-administered questionnaire comprising the diagnostic methods, treatment principles, etc. Kobo Toolbox data collection software will be used to create the online data collection template and gather the data except for the self-administered questionnaire. The link will be sent to each data collector via email, WhatsApp, and telegram address. The participants will be briefed about the techniques to collect and submit the data properly. The principal investigator will check the delivery of the data and its completeness by signing in using the user account, and necessary actions will be undertaken. The passcode for the Kobo Toolbox account will not be shared with others who are not involved in the study as co-author.

The qualitative data will be triangulated, incorporating observational, FGDs, in-depth interviews, and key informant interviews. Data gained from field notes and interviews will be used to support the data obtained through the observation checklist. Using a flexible and piloted interview guide, the discussion and interviews will be underway by experienced interviewers. In other words, senior PhD students studying public health whose first language is Amharic, the local language, and who have experience as FGD moderators and individual interviewers will be recruited. The interview will be recorded using tape recorders.

All tools will be developed in English, translated to Amharic, and then back to English to ensure consistency. The face and content validity of the questionnaire will be done by a panel of reviewers who are nutritionists, paediatrics and child health specialists, and monitoring and evaluation experts. A pilot test will be conducted on the non-selected health posts. A reliability test will be done, and a Cronbach alpha of ≥ 0.7 will be considered as the tool is reliable. Four nurses and two general practitioners/pediatric nurses (MSc holders) will be recruited for data collection and supervision, respectively. A two-day training about data collection procedures and participant handling will be delivered for data collectors and supervisors. Inter-rater variability among observers will be managed by referencing each item in the checklist and employing data collectors with similar work experience and educational status. Stringent supervision by trained supervisors will be done, and daily joint discussions with supervisors and the research team will be undertaken to identify gaps and give feedback on the data collection process.

Experts will transcribe the qualitative data after repeatedly listening to the audio recordings. Moreover, the data collectors will introduce themselves, the aim of the study in detail (not to evaluate/judge them) and establish a rapport with the participants to minimize the Hawthorne effect during observation [24, 25].

Data management and analysis

Quantitative data

A nutritionist under the guidenace of a statistician will do the data management and analysis. The statistician will assist the nutritionist in the measurement of variables and their interpretation. A data dictionary document will be prepared. Data on acceptability, compliance, adherence, treatment outcome, and the skills of HEWs about management and diagnosis of SAM collected by the Kobo toolbox online data collection platform will be downloaded in an excel spreadsheet. Likewise, data on knowledge of HEWs about management and diagnosis of SAM will be entered into EpiData version 4.6 software and exported to an excel spreadsheet. The data will be merged and exported to STATA version 14 for further analysis. Data cleaning will be completed, and the procedure followed with actions taken will be recorded in an excel spreadsheet. Missing data will be managed using proper imputation methods/models based on the nature of the variables (i.e., categorical or continuous). Descriptive statistics will be computed, and the results will be presented using tables, graphs, and narrations. A binary logistic regression will be employed for outcomes like HEW’s knowledge, skills, and acceptability. The basic binary logistic regression assumption (e.g., chi-square) will be checked. The participant’s age (in years), work experience (in years), training experience, level of education, and income will be used as independent variables that will be fitted in the multivariable logistic regression model to examine the association with HEWs knowledge and diagnosis skills. Similarly, waiting time, travel distance, mother’s/caregiver’s age, income, marital status, educational status, and employment status will be tested for association with the mother’s/caregiver’s acceptance. Continuous variables such as age and year of experience will not be categorized to build in the multivariable model [26, 27]. Considering the few numbers of independent variables in this study and to better control the confounding effect, the ‘full-model fit’ technique will be used [28]; all independent variables will be transferred to the multivariable logistic regression regardless of using a cutoff value such as p-value to transfer from the bivariable to multivariable analysis. The association of all independent variables with each outcome variable will be examined. Variables having independent associations with the outcome variables mentioned above will be identified based on the Adjusted Odds Ratio (AOR) and p-value corresponding to 95% CI. Variables with a p-value of ≤0.05 will be considered statistically significant.

Qualitative data

The recorded audio will be transcribed, and the script to be translated to English will be developed. The data will be entered into NVivo version 12 software. The six-phase thematic data analysis procedure will be applied [29]. The researchers will repeatedly read the script and identify the meaningful units to create codes, collate codes into themes, review themes, label the generated themes, and report the findings. Before creating the themes and subthemes, disagreements between the coders will be resolved. A codebook will be generated accordingly.

A thematic analysis approach will be made. Themes and subthemes will be presented based on the findings and the existing literature in similar studies. Besides, a word-association test will be applied to identify the outranked concepts and phrases reflected by participants, and the results will also be compared using the chi-square test [30].

Integration of the qualitative and quantitative data

A concurrent mixed-method approach will be applied; the quantitative and qualitative data will be collected parallelly. Before starting the qualitative data collection, researchers will critically evaluate the quantitative tool to extract discussion points and concepts uncovered during the quantitative data collection to raise and incorporate in the interview guide. The data integration will be applicable for acceptability, availability, and compliance. The mothers’ acceptability determined using a quantitative approach will be supported by data from mothers’/caregivers’ interviews. The quantitative data on the availability and functionality of the essential equipment in each health post will also be backed by qualitative data gained through field notes and interviews. Similarly, the compliance determined by the quantitative approach will be supported by interviews of HEWs and observations during reviewing children’s recordings.

Ethical considerations

The study protocol has been submitted and approved by the Ethical Review Board (IRB) of the University of Gondar. Reference number: V/P/RCS/05/836//2021, issued on 23/022021. The study’s progress report will be submitted to the International Institute for Primary Health Care-Ethiopia (IPHC-E) coordinating office. Since the study will not involve invasive procedures, oral informed consent will be obtained from mothers/caregivers, HEWs, health extension supervisors, and other critical informants. Before the data collection, participants will be briefed about the aim of the research and their right to withdraw from the study at any time if they feel uncomfortable to continue. The study participants will receive compensation in monetary means (for the qualitative only) that will cover their travel and other related expenses related to the time they spend in the data collection. Mis-classified/diagnosed children by HEWs will be treated, and severe cases exhibiting medical complications will be referred to the nearby stabilization centres.

Children’s names will be anonymized during chart review before the data collectors begin data collection, and identification numbers will be given to each chart. The collected data will be kept secure in the locked cupboard, and the data will be shared on a reasonable request.

Discussion

Severe acute malnutrition is a significant public health problem contributing to over half of the under-five mortality in Ethiopia [31]. The C-OTP has been launched to reduce mortality and maximize population-level impact by improving treatment coverage, access, and cost-effectiveness [3]. The program was founded on three essential premises: First, if malnourished children gain access to nutritional care early in the evolution of their condition, the success rates may be high. Second, mothers/caregivers must understand, accept, and participate in the programs to attain the program goal and intended outcomes. Lastly, for the programs to move toward sustainability, there must be an up-front investment in social mobilization to ensure that critical stakeholders can benefit from the positive feedback from consumers [3].

Despite the substantial achievements of the C-OTP in reaching a large number of children with SAM, the program has been threatened with untoward treatment outcomes (death and dropout), lack of community engagement, shortfall of resources, scarce of competent HEWs, and misuse of resources [6, 32]. Likewise, the program’s effectiveness and efficiency have also been an area of disagreement.

This implementation evaluation research will identify gaps related to healthcare systems and service users to bring comprehensive findings that reflect the program’s different dimensions that have contributed to the effectiveness of the C-OTP in Ethiopia. First, the study will reveal the HEW’s competency in managing uncomplicated SAM. Then healthcare-related factors, including a shortfall of necessary materials for community-based management of uncomplicated SAM, will be identified. Moreover, the study will show the program’s acceptability by the beneficiaries. To this end, program managers, policymakers, and other stakeholders will utilize the finding to enhance the program’s performance and pass evidence-based and sound decisions to track the program.

Amendments of the study

Any acceptable change made during the data collection period, participant recruitment, methods of analyses, and other addition and deletion of methods will be declared during reporting manuscripts.

(DOCX)

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8 Apr 2022

Evaluation of the community-based outpatient therapeutic program implementation for management of children with severe acute malnutrition: a mixed-method evaluation protocol.

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Reviewer #1: This is a study protocol for an implementation evaluation of the critically important public health concern that severe acute malnutrition presents among children when they are most vulnerable to poor nutrition. The rationale presented by the authors is clear and the research question and proposed methodology is justified.

More detail is required on the proposed methods to ensure sufficient detail to allow replication/reproduction. For example, what approach will be taken for thematic analysis (inductive, deductive, etc.) or describe what type of thematic analysis (reflexive, codebook, etc.) An implementation evaluation framework is described but there is no reference to relevant sources that support the approach proposed.

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Thank you for the opportunity to review this manuscript. Consideration of the points raised will, I believe, lead to an improved report and a thorough account of your intended research.

Reviewer #2: The protocols attempts to evaluate the implementation of Community-based Outpatient Therapeutic Program (C-OTP) for managing uncomplicated severe acute malnutrition in Central Gondar Zone using mixed-method evaluation. Though the manuscript address an interesting topic of the study it is not suitable for publication in its current form, since there is unclear or incomplete scientific reasoning on methodology presented and data analysis in this manuscript. Following are some of the concerns to address, before taking a decision.

1. My primary concern is that the manuscript mentions that the study data collection completes by 30th of December 2021, and after the completion of data collection, publication of protocol limits the purpose of the publication.

2. The manuscript failed to document the triangulation/integration of both quantitative and qualitative approaches. Moreover, the methods section of this manuscript is vaguely presented and discussed about the proposed data collection, management, role and responsibilities of its team and analytical methodology which needs clear explanation to understand study and implementation. For example, more description on research design, study area, assumptions for sample size calculation, sampling framework, inclusion/exclusion criteria, analytical framework/analysis of data, timeframe, and data safety and sharing mechanisms. Also the manuscript has not followed any standard guidelines and lacks clear definition and measurement of outcome specific indicators and their components/ validation of tools/scales used. Though here and there, the author(s) stated about all these but these needs to be structured in data and methods section.

3. Definition and measurement of outcome variables needs further more discussion. In other words, though the protocol proposes multiple composite indexes (viz., for Availability, Acceptability, Compliance and indicators of knowledge about uncomplicated SAM) to address the study objective with different scales, the authors failed to describe the components of each of the indexes and its validation. The study requires involvement of a statistician and the data analysis plans vaguely discussed in this protocol.

4. The write up of the protocol is too clumsy. Most of the time readability compromised and requires structural and careful review with professional language editing. The manuscript ends rather abruptly.

In conclusion, though the novelty of this protocol is limited, the experimental design, methods, expected outcomes may beyond state of art. However, before taking a decision for possible consideration of publication, the manuscript needs further more description and revision on its structure, completeness and language.

**********

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: Yes: Dr Anne Griffin

Reviewer #2: No

[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.

10 May 2022

Point-by-point response

Dear editor and reviewers, thank you for giving us critical comments. The comments have a paramount positive impact on improving the readability and acceptability of the manuscript. We have provided responses to each concern and question. Kindly find it here below.

Editor’s comments:

1. In the Methods section please provide additional information regarding the qualitative study methodology. In particular, please describe how participants will be recruited for the study, whether an interview guide will be used, and the training and background of the interviewers. Furthermore, please provide additional information regarding the questionnaire development and validation. Please also include a copy of the questionnaire as supporting information.

Response: Comment accepted, and necessary revisions have been made. A copy of the questionnaire has been attached. Moreover, the validity and reliability procedures are now well presented in the revised version of the manuscript.

2. We suggest you thoroughly copyedit your manuscript for language usage, spelling, and grammar. If you do not know anyone who can help you do this, you may wish to consider employing a professional, scientific editing service.

Response: the comment has been accepted. A native academic speaker did the proofreading.

3. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found.

Responses: Commented accepted. Although this is a protocol that doesn’t obviously include results, we have described the data availability plan.

Reviewer #1

1. More detail is required on the proposed methods to ensure sufficient detail to allow replication/reproduction. For example, what approach will be taken for thematic analysis (inductive, deductive, etc.) or describe what type of thematic analysis (reflexive, codebook, etc.).

Response: Commented accepted.

2. An implementation evaluation framework is described but there is no reference to relevant sources that support the approach proposed. There is no mention to appropriate reporting guidelines to ensure the rigorous reporting of results.

Response: Dear, we have cited the source from which we have taken the frameworks. You are right; there should be reporting guidelines for each study research approach employed. We have accepted the comments. See the updated version on page…

3. While there is mention by the authors of the data being available on completion of the study it is not clear that this will be in an open-source repository?

Response: The data availability plan has been described. We will supply the dataset as supplementary material while submitting the manuscripts for publication.

Reviewer #2:

1. My primary concern is that the manuscript mentions that the study data collection completes by the 30th of December 2021, and after the completion of data collection, the publication of the protocol limits the purpose of the publication.

Response: Dear, we genuinely share your concern, and we believe that the issue should be raised. Nevertheless, the protocol was submitted back in August, and the review process is unfortunately delayed. Considering the nature of the manuscript (protocol), we had contacted the journal several times to expedite the reviewing process; unfortunately, it wasn’t possible. However, although now the data collection has been finalized, the actual data collection had been delayed because of the COVID and local security issues, and we believe that publishing the protocol still is worthwhile. Dear, we believe that publishing the protocol would provide knowledge to the prospective scholars to replicate and follow whenever they want to carry out similar studies; it will serve as a guide. We trust that it’s rare to see the protocols of evaluation studies published. Thus, this will be served as a guide. In fact, the full-length articles that will be produced and published from the project may serve as a guide, however, the objectives of the project will be split and published separately. Thus, comprehensive information for future researchers who want to evaluate the same program may not be available. All in all, although the study has already been completed, the protocol will help prospective scholars in planning the same study in different corners of the world.

2. The manuscript failed to document the triangulation/integration of quantitative and qualitative approaches.

Response: Comment accepted, and detailed descriptions of the procedures are now presented in a separate subheading.

3. Moreover, the methods section of this manuscript is vaguely presented and discussed the proposed data collection, management, role and responsibilities of its team, and analytical methodology which needs a clear explanation to understand the study and implementation. For example, more description of research design, study area, assumptions for sample size calculation, sampling framework, inclusion/exclusion criteria, analytical framework/analysis of data, timeframe, and data safety and sharing mechanisms.

Response: Dear, exact and relevant information has been provided. Comment accepted, and we substantially revised the section considering the untouched areas. Of the responsibilities of each team member, we believe it’s uncommon to see such narrations in such protocols, and we didn’t find this in any reporting guidelines available in the EQUATOR network (https://www.equator-network.org/). Of course, during a systematic review, it’s common to see in protocols who will do what. However, if you believe it is necessary, we are ready to modify it in the next revision.

Dear, we didn’t calculate the sample size, as there are few participants/cases (health posts) in the three districts. We planned to consider all health posts and HEWs in the districts. Similarly, we didn’t use any random sampling technique and didn’t present a sampling frame; we will employ participants consecutively. We could have incorporated more than three districts and used a random sampling technique; however, there are limited resources (time and money). The details are presented under ‘sample size and sampling procedure’ on page #4. Dear, we don’t have particular criteria to exclude participants other than the criterion we have already stated for exclusion criteria. The data analysis, study design, and area are precisely presented. Moreover, the ethical consideration section explains the data safety and sharing mechanisms.

4. Also, the manuscript has not followed any standard guidelines and lacks a clear definition and measurement of outcome-specific indicators and their components/ validation of tools/scales used.

Response: Dear, as you know, there is no unique guideline for evaluation studies to prepare and report the protocol, unlike systematic review and trial studies. However, as the approaches we will follow are qualitative and quantitative studies, we have followed guidelines developed for observational (cross-sectional) and qualitative studies Consolidated Criteria for reporting qualitative research (COREQ). The manuscripts will be reported according to the respective recommended guidelines. We have added the procedures used to frame the protocol in the newly revised manuscript.

Sources:

https://cdn-links.lww.com/permalink/acadmed/a/acadmed_89_9_2014_05_22_obrien_1301196_sdc1.pdf

https://academic.oup.com/intqhc/article/19/6/349/1791966

https://www.equator-network.org/wp-content/uploads/2015/10/STROBE_checklist_v4_cross-sectional.pdf

Note: we didn’t supply those reporting guidelines as there are no separate guidelines for protocols, as noted earlier.

5. The definition and measurement of outcome variables need further discussion. In other words, though the protocol proposes multiple composite indexes (viz., for Availability, Acceptability, Compliance, and indicators of knowledge about uncomplicated SAM) to address the study objective with different scales, the authors failed to describe the components of each of the indexes and its validation.

Responses: Comment accepted, and necessary modifications have been made. We have provided very brief information regarding the validation in the data quality section. We didn’t give each outcome headings not to repeat texts and make the reading tedious. As the validation and reliability assuring procedures are common to all variables, we don’t believe that a detailed description of all outcomes is required.

6. The write-up of the protocol is too clumsy. Most of the time, readability is compromised and requires structural and careful review with professional language editing. The manuscript ends rather abruptly.

Response: An academic native speaker has done proofreading.

Thank you!

Wubet Worku Takele(t)he corresponding author

Submitted filename: Point-by-point response-Plos.docx

Click here for additional data file.

22 Jun 2022

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PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: No

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: No

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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: Yes

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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: No

Reviewer #2: No

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thank you to the authors for taking careful consideration of the previous review of this manuscript. It reads much more clearly and is more descriptive of the proposed research.

However, there are some points that require further detail:

Methods:

The context/description of the C-OTP programme remains vague. I suggest the inclusion of a diagram or similar illustration to describe the care pathways.

There is frequent reference to the 'protocol' - I am assuming that this is a protocol for the delivery of the C-OTP. However, it could also be the SAM guide (reference 19). Could a clear reference be provided and the protocol made available as supplementary material?

There is some explanation as to who is carrying out the data collection provided at the end of the methods section. More clarity as to their exact role would be appreciated. For example, lines 204-205 - what are the 'departments' that are referred to (clinical/university/government?).

Suggest the authors reconsider or define the use of data saturation as an indicator that all available information has been gathered using qualitative methods (lines 122).

The access framework proposed is from 1974 (line 125). Given the recent significant development of implementation frameworks, why have the authors chosen this?

Line 133 - the definition of 'availability' is confined to equipment/resources required to support the C-OTP. This seems at odds to the research aim and programme provision. It is also not the definition held within the cited access framework reference.

A reference is required for the Hawthorne effect (line 217).

What framework/theory will support the deductive analysis of the qualitative data? The authors mention 'existing literature' - has an evidence synthesis of existing literature been performed? (line 234-235).

What methodology does the 6-step process of qualitative analysis and coding refer to? (I'm assuming Braun & Clarke?).

Line 240: I am unclear whether the "questions and concerns" to discuss at interview arise from previously completed surveys/questionnaires? A timeline to support the flow process of the evaluation study would help to clarify.

Edits/Grammar:

This has much improved but there are some unresolved grammatical errors. There are acronyms used throughout that are not fully explained at first use, e.g., MUAC. There is also inconsistency in the application of C-OTP (lines 6, 27 and 45). This should be double-checked throughout the manuscript. I would also suggest that appropriate language is considered in the discussion, line 273, and the use of "victims" to describe the population of interest in this research.

A remarkable amount of work is being considered within this protocol and I appreciate the authors efforts to date to consider that it will provide future guidance to similar research.

Reviewer #2: I would like to congratulate the author(s) to adequately addressing reviewers concerns to some extent satisfactorily. While the authors have made some amendments to the protocol which improves the text, the concerns I have in the definition of outcomes measures and proposed methods of analysis of data (analytical framework) remain and failed to address the concerns raised in the first round of review process. The authors suggested to (a) strengthen methods section of this protocol and needs clear explanation to understand project. The protocol has not discussed role and involvement of a statistician and the data analysis plans also vaguely discussed in this protocol (instead of ‘binary Binary logistic regression analysis will be conducted’, discuss/list out the type, definition and measurement of select outcomes/dependent variables along with possible independent variables). (b) discuss the data collection and management process, data entry (electornic/double data data entry, data quality validation and assurance; (c) since the data collection completed before the publication of the protocol, it is suggested to present the date of completion of data collection and final status of data along with any inclusions/exclusions, missing values etc., (d) discuss the filed level operation issues and lessons learnt; possible measures adopted etc., during the study data collection/implementation.

In conclusion, the subject addressed in this study protocol is worth of investigation and recommend for possible consideration.

**********

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: Yes: Dr Anne Griffin

Reviewer #2: Yes: Ramesh Poluru

**********

[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.

30 Jun 2022

Date: 29/06/2022

Point-by-point response

Dear editor and reviewers, thank you for giving us critical comments. The comments have a major positive impact on improving the readability and acceptability of the manuscript. We have responded to each concern and question. Kindly find it here below.

Reviewer #1

1. The context/description of the C-OTP program remains vague. I suggest the inclusion of a diagram or similar illustration to describe the care pathways.

Response: Dear, your comment is found to be valid. We have added detailed descriptions of how the program is being operated.

2. There is frequent reference to the 'protocol' - I am assuming this is a protocol for delivering the C-OTP. However, it could also be the SAM guide (reference 19). Could an apparent reference be provided and the protocol made available as supplementary material?

Response: Yes, you are correct that ‘protocol’ refers to the SAM guideline. We use the term treatment protocol/guidelines interchangeably. We have revised the manuscript. The country uses the national SAM guideline for both in-patient and outpatient SAM management. There is no unique guideline for C-OTP.

3. There is some explanation as to who is carrying out the data collection provided at the end of the methods section. More clarity as to their exact role would be appreciated. For example, lines 204-205 - what are the 'departments' that are referred to (clinical/university/government?).

Response: comment accepted.

4. Suggest the authors reconsider or define the use of data saturation as an indicator that all available information has been gathered using qualitative methods (lines 122).

Response: comment accepted. The definition of data saturation has been provided in the revised version of the manuscript.

5. The access framework proposed is from 1974 (line 125). Given the recent significant development of implementation frameworks, why have the authors chosen this?

Response: dear, you are correct that there are interesting frameworks to evaluate the implementation of a program, specifically the barriers and facilitators, including the Consolidated Framework for Implementation Research (CFIR) and Theoretical Domains Framework (TDF). Initially, we tried to design the tools and interview guide considering the constructs of CFIR, nevertheless, we decided that some of the constructs may not fit to our objective, and we believe that the access framework would fit our study. There is an updated framework developed by the WHO which supports the access framework (https://www.who.int/publications/i/item/9789241502894. Even the nomenclature of the framework and dimensions included are identical, ‘access framework’. We also decided that the qualitative part should be presented in using thematic analysis. Thank you for the wonderful insight, and we will think of applying such frameworks in our future work to better design tools/guide and report findings.

6. Line 133 - the definition of 'availability' is confined to equipment/resources required to support the C-OTP. This seems at odds with the research aim and program provision. It is also not the definition held within the cited access framework reference. A reference is required for the Hawthorne effect (line 217).

Response: Dear, we can see your critical view. Yes, the definition of ‘availability’ is beyond checking the physical availability and functionality of essential medical equipment in a given healthcare institution. It would mean the service/program availability in a particular healthcare institution. As you said, this is clearly described in the cited article. This concept is partly addressed by our study’s ‘acceptability’ domain. That section addressed the waiting time, travel time, and so forth. Our study defines availability as the physical availability and functionality of essential equipment. For this, we used another framework developed by the World Health Organization (WHO) (https://www.who.int/publications/i/item/9789241502894). Still, the concept is under access framework. We have cited the article in the revised manuscript.

As to the concern of providing reference to a strategy designed to mitigate the Hawthorne effect, we have modified the strategy that we used. It’s an interesting comment. We have been waiting for the opportunity to revise the statement based on the actual strategy we have applied during the actual data collection. Dear, the previous strategy was based on what we hear/learned from expertise and senior scholars, but we couldn’t get evidence to support it. Some scholars suggest that method (discarding recordings) if the design is ‘grounded theory’, which is not similar to our aim. We then change our minds and apply other strategies that are backed by evidence. The detail is presented in the revised version of the manuscript.

7. What framework/theory will support the deductive analysis of the qualitative data? The authors mention 'existing literature' - has an evidence synthesis of existing literature been performed? (line 234-235).

Response: Dear, sorry for not updating the manuscript. Initially, as described earlier, we had planned to employ a framework, namely CFIR, to gather and analyse the data. However, after reviewing the constructs of this framework, we decided not to apply it. We rather planned to use thematic analysis and now we are analysing the data using thematic analysis referencing the Braun & Clarke’s guide for analysing qualitative data using the thematic analysis approach. https://www.tandfonline.com/doi/pdf/10.1191/1478088706qp063oa?needAccess=true

Yes, indeed, we have reviewed some literature to prepare our interview guide in order not to miss significant attributes/concepts that need to be explored. Although we didn’t review exactly similar studies, we have reviewed studies done in healthcare aiming at exploring factors affecting the level of implementation of health services/programs. Then experts in the field have tried to conceptualize the questions to prepare a flexible and comprehensive interview guide. Some themes will be generated based on the previous studies’ themes with or without modifications. For example, one of the elements of the interview guide we adopted from the literature was ‘miss use of therapeutic foods.’ While developing our guide, including this concept would help yield relevant information on the consumer’s side. Thus, we will have a theme stating the how mothers/caregivers use the given therapeutic food.

8. What methodology does the 6-step process of qualitative analysis and coding refer to? (I'm assuming Braun & Clarke?).

Response: yes, we will follow Braun & Clarke’s six phases of qualitative thematic data analysis. https://www.tandfonline.com/doi/pdf/10.1191/1478088706qp063oa?needAccess=true. We have cited the article.

9. Line 240: I am unclear whether the "questions and concerns" to discuss at the interview arise from previously completed surveys/questionnaires? A timeline to support the flow process of the evaluation study would help to clarify.

Response: Dear, you are correct that the message was confusing. It seems to be a sequential mixed-method approach will be used. We have modified the statement to avoid confusion. Dear, we have collected the data (both qual and quant) parallelly if possible. In exceptional cases, the quantitative preceded the qualitative data, but it doesn’t mean the approach is sequential instead, it’s to manage the data collection.

10. This has much improved, but there are some unresolved grammatical errors. There are acronyms used throughout that are not fully explained at first use, e.g., MUAC. There is also inconsistency in the application of C-OTP (lines 6, 27 and 45). This should be double-checked throughout the manuscript. I would also suggest that appropriate language is considered in the discussion, line 273, and the use of "victims" to describe the population of interest in this research.

Response: comment accepted and a detailed revision has been made.

Reviewer #2

1. Strengthen methods section of this protocol and needs clear explanation to understand project. The protocol has not discussed role and involvement of a statistician and the data analysis plans also vaguely discussed in this protocol (instead of ‘binary Binary logistic regression analysis will be conducted’, discuss/list out the type, definition and measurement of select outcomes/dependent variables along with possible independent variables).

Response: the comment is found to be valid and the necessary revision has been made. A significant change has been made.

2. Discuss the data collection and management process, data entry (electornic/double data entry, data quality validation and assurance

Response: Comment accepted and we have incorporated it in the revised document. The data quality assurance techniques are described in the ‘data collection tools, procedures, and quality assurance’ section.

3. Once the data collection completed before the publication of the protocol, it is suggested to present the date of completion of data collection and final status of data along with any inclusions/exclusions, missing values, etc.

Response: Dear, your comment is appreciated. However, as you know in principle, a study protocol is supposed to be published/disseminated before the actual work begins. If we put the actual date of completion, excluded/included participants, and how the missing data was managed, we feel it seems a manuscript of an actual study and may confuse participants. Dear, all the plans regarding the above-mentioned points are already presented in the protocol.

Scholars usually recommend considering an ‘amendment plan’ during preparing a protocol and some journals recommend to incorporate this although it is not available in any of the protocol reporting guides like PRISMA-P and SPIRIT. In this sense, to increase transparency, level of flexibility, and clarity, we have added an amendment section in the revised version, which is the recommended practice while preparing a protocol. However, if you feel the issue is major and needs to be considered, we are delighted to incorporate it before the protocol is published and released online.

4. Discuss the filed level operation issues and lessons learnt; possible measures adopted etc., during the study data collection/implementation.

Response: Dear, we highly value your comment. We lack the confidence to incorporate the points raised here as we couldn’t find a reference to cite. It’s not associated with loss of trust. As you know, scholars are recommended to follow a scientific format to prepare and report studies. We try to review a protocol reporting guidelines; no guideline like SPRIT (for trail studies) and PRISMA-P (for systematic review and meta-analysis) that contains items stated regarding your points to be considered when preparing and disseminating a protocol once an actual study is finalized or begun. Nevertheless, if it’s your strong recommendation to incorporate this point in the protocol, we are ready to accept your comment.

SPRIT: https://www.spirit-statement.org/wp-content/uploads/2013/01/SPIRIT-Checklist-download-8Jan13.pdf

PRISMA-P: https://pubmed.ncbi.nlm.nih.gov/25554246/

Note: these checklists are not relevant and applicable to our study. It’s just to show the concerns you raised are not common to be considered while preparing and publishing study protocols.

Thank you!

Wubet Worku Takele (the corresponding author)

Submitted filename: Response to Reviewers.docx

Click here for additional data file.

26 Aug 2022

Submitted filename: PONE-D-21-25442_R2.pdf - Reviewer comments.docx

Click here for additional data file.

8 Sep 2022

Date: 08/09/2022

Point-by-point response

Dear Editor and reviewers, thank you for giving us critical comments. The comments have a significant positive impact on improving the readability and acceptability of the manuscript. We have responded to each concern and question. An academic native speaker has edited the language.

Kindly find it here below.

Reviewer #1

1. Thank you to the authors for their careful attention and further development of this manuscript. I have some minor issues with the manuscript that I outline in the uploaded word document that details suggested amendments to the text.

Response: dear reviewer, we are grateful for the comments. We have fully incorporated the editorial and typo comments.

2. Line 133-136: It is unclear if the focus group discussions will contribute to the qualitative data. Consider the position of the sentence about the logic of this section describing procedures.

Response: comment has been accepted, and the sentence has been re-arranged.

3. Line 154, p6: clarification required that ‘good acceptance’ is defined as mothers answering to a consensus of “agree/strongly agree” rather than the total number of mothers responding to the questions (where any answer might be given).

4. Response: Dear, if we get your concern, the definition needs to be based on the mother’s response, not the proportion of mothers/caregivers who have ‘agreed/ disagreed’. We have revised the statement to clarify more.

5. Table 1: remove the gender pronouns from row 5 describing compliance/adherence measures.

Response: your comment has been accepted.

6. Line 235: Please clarify if it is a nutritionist or a statistician who will perform the data analys.s? I assume that the nutritionist will be ably assisted by a statistician in analysing and interpreting the data based on the previously described methodology.

Response: Yes, you are correct that the nutritionist will do the analysis; we assume the nutritionist is knowledgeable about the variables and their definition; the nutritionist will do the analysis and be supported by a statistician. We have revised the document.

7. Line 265-266: Can you define what is meant by “level the generated themes” – is it refining, defining and naming the themes?

Response: Dear, sorry for the typo error. It was to say ‘label/name’, not level.

8. Line 11: suggest the use of the word ‘factors’ instead of “indicators” to describe those elements of the programme that can be evaluated for implementation and avoid the repetition in line 12.

.

Response: Dear, we appreciate your perspective. Thank you for giving this comment. However, as can be recalled from our previous response, ‘indicator’ is an appropriate technical term used to describe the detail of programs. The evaluation is performed based on this key indicator. When we say ‘indicator’, we are not referring to factors(barriers/enablers) contributing to the program’s implementation. All in all, we prefer to use the term indicator over factor. Following your comment, we authors have discussed and have sought an explanation from one of the evaluation experts (co-author), and we have agreed to continue with ‘indicator’.

Reviewer #2

1. While the authors have made some amendments to the manuscript which improve the text, the concerns I have in the analysis of data /results, remain and failed to address the concerns raised in the first round of the review process on integration/triangulation of results from both qualitative and quantitative approaches (mixed-methods), adequately. The authors suggested discussing the rationale for using both qualitative and quantitative approaches and how they combine the elements of both qualitative and quantitative research approaches to address the study objectives. Since my primary concern is that the manuscript failed in triangulation/integration of results. Moreover, the manuscript contains insufficient data and explanations in addressing the crucial aspects of the study.

Response: Dear reviewer, thank you for the comment. We believe we have provided rich information on how the qualitative and quantitative data will be integrated (see page 12). Dear, as you know, this is a protocol (it doesn’t include results), and we don’t have the data yet to show the actual integration. What we have discussed in this section is the plan.

2. Among the minor concerns about the methodology, the authors suggested to discuss on the study setting, data collection process, selection and recruitment of sample participants etc., in order to avoid data dredging. Moreover, I feel the manuscript is certainly less disjointed (study implementation, linkage with the qualitative results, utilization of results from both qualitative and quantitative data analysis) and I would urge the authors to have another good 'go' at the report, post-acceptance, as I am sure they will be able to make further minor improvements in structure and presentation. Also avoid typo errors (for instance, “Similarl,”; “Ethiopi a” etc.). I would also suggest someone who has statistical knowledge and, just to knock off the rough edges on the definition and measurement of the dependent variables like knowledge of HEWs about SAM; compliance of HEWs to the C-OTP protocol; acceptability of C-OTP of the service; severely malnourished children etc.

Response: we have incorporated the editorial comments. For your information, we have proposed the measurement strategies after consulting a statistician. We will update the analysis if we find a revision is required after discussing it with co-authors, including the statistician.

Thank you!

Wubet Worku Takele (the corresponding author).

Submitted filename: Point-by-point response-Plos.docxR3.docx

Click here for additional data file.

27 Sep 2022

Evaluation of the community-based outpatient therapeutic feeding program implementation for managing children with severe acute malnutrition in Northwest Ethiopi a: a mixed-method evaluation protocol.

PONE-D-21-25442R3

Dear Dr. Worku Takele,

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.

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Kind regards,

Bassey E. Ebenso, Ph.D., M.P.H., M.D.,

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Your revised manuscript (Revision 3) has sufficently addressed reviewers comments.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 #2: No

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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 #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: I would like to congratulate the author(s) to adequately addressing reviewers concerns to some extent satisfactorily. I would urge the authors to have another good 'go' at the manuscript, as I am sure they will be able to make further minor improvements in structure and presentation, just to knock off the rough edges.

In conclusion, the subject addressed in this protocol manuscript is worth of investigation and recommend for possible consideration.

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Reviewer #2: Yes: Ramesh Poluru

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30 Sep 2022

PONE-D-21-25442R3

Evaluation of the community-based outpatient therapeutic feeding program implementation for managing children with severe acute malnutrition in Northwest Ethiopia: a mixed-method evaluation protocol.

Dear Dr. Takele:

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.

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on behalf of

Dr. Bassey E. Ebenso

Academic Editor

PLOS ONE