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. 2021 May 5;16(5):e0250920. doi: 10.1371/journal.pone.0250920

Perceptions on respectful maternity care in Sri Lanka: Study protocol for a mixed-methods study of patients and providers

Malitha Patabendige 1,‡,¤,*, Suneth Buddhika Agampodi 2, Asanka Jayawardane 3, Denagamage Jayamini Wickramasooriya 4, Thilini Chanchala Agampodi 2
Editor: Tanya Doherty5
PMCID: PMC8099093  PMID: 33951090

Abstract

Background

Over the past few decades, interest in providing and measuring Respectful Maternity Care (RMC) has increased markedly. Sri Lanka is reportedly shown to have better maternal health statistics and studies on quality improvement are lacking in this unique population. We aim to describe healthcare providers’ perceptions and women’s expectations, perceptions and their gaps in service provision regarding RMC in Sri Lanka.

Methods

A descriptive cross-sectional study with a mixed-methods approach comprising of qualitative component followed by a quantitative component will be conducted in Castle Street Hospital for Women (CSHW) and De Soysa Hospital for Women (DSHW), Colombo, Sri Lanka. Healthcare providers (HCP- doctors, nurses and midwives) and vaginally delivered postnatal women (in postnatal wards and postnatal well-baby clinics) will be recruited through convenience sampling. In-depth interviews will be conducted with each of the four categories. Thematic analysis will be adopted to analyze qualitative data and the findings will further be used to improve the quantitative phase questionnaires. Self-administered questionnaire will be administered to a 378 vaginally delivered postnatal women [quota sampling across ten wards], exploring demographic details, and maternal opinion on various aspects of RMC. Locally validated Women’s Perceptions of RMC tool (WP-RMC) will also be used to measure the level of RMC among these postnatal women along with the questionnaire 01. Qualitative findings will be used for cognitive validation of the WP-RMC into the Sri Lankan setting.

Discussion

This study will explore HCP’s and women’s expectations, perceptions and their gaps in service provision regarding RMC in two maternity hospitals in Sri Lanka. Assessment of the quality of care with regards to RMC have not been reported previously in this setting.

Introduction

Improving quality of maternal and newborn care in healthcare facilities is identified as a key factor in further reduction of maternal deaths [1]. Respectful maternity care (RMC) plays a main role considering quality of services. The World Health Organization defines RMC as “care organized for and provided to all women in a manner that maintains their dignity, privacy, and confidentiality, while ensuring freedom from harm and mistreatment, and enables informed choice and continuous support during labor and childbirth” [2,3].

At present, “disrespectful maternity care” is common and widespread worldwide [4,5]. It may include physical or sexual violence such as hitting, undue restraints, and unnecessary exposure of the woman’s genitalia and rough vaginal examinations. Women at childbirth often become victims of verbal abuse and may experience "neglectful care" consisting of restricted mobility, leaving laboring alone, unsupportive birth attendants, and withholding of food and/or drink [57]. Women might experience serious injuries and mistreatment both physically and emotionally. Higher rates of maternal as well as neonatal and infant mortality and morbidity is associated with disrespectful maternity care in LMICs [4]. Existence of RMC has good short-term and long-term outcomes on the mother and her family [8]. A review by Shakibazadeh et al., in 2018 have concluded that the concept of RMC is broader than just reduction of disrespectful care or minimising mistreatment of women during childbirth [9]. Twelve domains of RMC have derived and described from the qualitative findings of this review and presented in Table 1.

Table 1. Twelve domains of the respectful maternity care.

Domains of the respectful maternity care
1) Being free from harm and mistreatment
2) Maintaining privacy and confidentiality
3) Preserving women’s dignity
4) Prospective provision of information and seeking informed consent
5) Ensuring continuous access to family and community support
6) Enhancing quality of physical environment and resources
7) Providing equitable maternity care
8)Engaging with effective communication
9)Respecting women’s choices that strengthens their capabilities to give birth
10) Availability of competent and motivated human resources
11) Provision of efficient and effective care
12) Continuity of care

Source: Shakibazadeh E, et al. Respectful care during childbirth in health facilities globally: A qualitative evidence synthesis. BJOG An Int J Obstet Gynaecol. 2018;125(8):932–42.

Sri Lanka is a role model for maternity care among LMIC countries with exemplary achievements [1012]. The maternal mortality ratio (MMR) for Sri Lanka is 32.0 per 100,000 live births in 2018 and it is an example of how low-cost, context-specific interventions could lead to exponential improvements in health indices. Nonetheless, maternal suicides play a significant role in maternal mortality in the country [13] reflecting poor psychosocial wellbeing of pregnant and postpartum women. Being in the fourth phase of obstetric transition [14] improvement of quality of care is of high priority in the country in order to further reduce maternal deaths. The importance of RMC for the Sri Lankan context is further reflected by the high cesarean delivery rates [40.5%] in the country and studies and assessments on the quality of care and quality improvement in Sri Lankan context is scarce. Furthermore, a survey among obstetricians have shown that a poor attitude 58.8% of Sri Lankan obstetricians were not allowing the labour companion and this can be considered as a very unfortunate situation in a setting like Sri Lanka [15]. Therefore, Sri Lankan setting is unique and Colombo contains the country’s two largest maternity hospitals (study settings) and are considered as model institutions in providing quality maternal healthcare [16]. Therefore, considering the above facts, this study aims to cover a timely need in Sri Lanka despite numerous research on this regard in neighboring India and other LMIC [1720].

This study aims to explore and describe the expectation- perception gap in RMC during labour and childbirth among women. The planned study is a novel concept for the Sri Lankan obstetric setting and is expected to yield more insight on recommendations to promote RMC.

Methods

Study design

A descriptive cross-sectional study with a mixed-methods approach comprising of qualitative component [in-depth interviews] followed by quantitative component [two self-administered questionnaires to vaginally delivered postnatal women].

Study setting

Study setting will be CSHW and DSHW, Colombo, Sri Lanka that are two major tertiary care maternity hospitals in Sri Lanka. Approximate annual delivery rate in CSHW is 11000 livebirths and that of DSHW is 8000. DSHW and CSHW are the first maternity hospitals situated in Sri Lanka and that they are considered as model institutions [16]. Therefore, any deficiency in the quality of care in these two referral hospitals situated in the capital Colombo can possibly represent much wider deficiencies elsewhere of the country. The RMC and mistreatment during labour have been extensively studied in other LMIC like India [17,18,21,22]. However, as a country with a relatively better maternal and neonatal statistics and being rewarded as a role model to other LMIC [11,12], this Sri Lankan study setting is different compared to other studies. Studies aiming strategies for quality improvement is a timely need in Sri Lanka. The ethnic breakdown of patients in these hospitals which would be valuable as it has a good representation of minority groups. In CSHW, there are five labour wards, four operating tables, one six-bed intensive care unit and three well-baby clinics per week. While in DSHW, there are five labour wards, four operating tables, one high-dependency unit, one three-bed intensive care unit and five well-baby clinics per week. Health staff involved in care provision includes approximately 200 medical officers, 300 nurses, 70 midwives, and 400 support staff in both hospitals.

Study population

HCP working in both hospitals, vaginally delivered women staying in postnatal wards and vaginally delivered women coming to well-baby clinics in CSHW and DSHW, Colombo, Sri Lanka, during the study period.

Qualitative phase

Study will be started with the qualitative phase in CSHW and DSHW, Colombo, Sri Lanka. In-depth interviews will be conducted covering main areas of RMC to explore women’s expectations and perceptions of RMC. As well as, RMC as perceived by the HCP.

Study participants for the qualitative phase

For the qualitative phase will belong to the following categories;

  1. Postnatal mothers in the ward and clinic: Mothers who have had their birth experience and staying in postnatal wards and mothers coming to well-baby clinics, will be invited.

  2. HCP working in antenatal wards, labour wards, and postnatal wards in CSHW and DSHW will be invited.

Inclusion and exclusion criteria for the qualitative phase

Criteria for women. Inclusion criteria

  1. Age at least 18 years old or more at the time of delivery.

  2. All the vaginally delivered postnatal women with an uncomplicated antenatal period.

  3. Not known to have fetal anomalies.

Criteria for HCP. Inclusion criteria

Three categories of HCP: doctors, nurses and midwives working in CSHW and DSHW during the study period.

Sampling method and sample size in the qualitative phase

Convenience sampling will be used to obtain an adequate representation of different types of HCP categories and mothers representing different ethnic groups, parities, educational and socio-economic status. The number of participants will be increased until data saturation occurs in each of the four arms of study participants- HCP [doctors, nurses and midwives] and postnatal mothers. As there are only four postnatal wards [4/10] belonging to units that are practicing the labour companionship, 50% of HCP and postnatal women will be recruited from these four wards and the rest from the other six postnatal wards.

Participant recruitment, interview guides and data collection procedure in the qualitative phase

Participants will be recruited maintaining an obstetric clinical diversity with regards to the mode of delivery and the neonatal outcome to yield representativeness during sample selection. If the postnatal women are giving insufficient information while staying the hospital possibly due to social response bias, postnatal interviews will be extended into the postnatal well-baby clinics where mothers will feel less threatened to give less socially desirable responses as they are not bound to the labour ward anymore. Recruiting and interviewing will be continued until the phenomena under the study are well understood and data saturation is reached.

Interviewer guides will be prepared according to the standard methods [23] separately for postnatal mothers [S1 File] and HCP [S2 File]. Trained accredited translators will translate all interview guides from the English language to Sinhala and Tamil languages. All dimensions of RMC will be considered in the preparation of the interview guides. With regards to the HCP, their perceived knowledge, practice and attitudes to promote RMC will be qualitatively assessed. Results of this part can improve the WP-RMC questionnaire validation and has the potential to generate providers’ perceptions on RMC. These interviewer guides were qualitatively pre-tested with a group of HCP (n = 10) and postnatal women (n = 10) in another hospital.

All interviews will be conducted in the first language of the participant. A female doctor and/or two female nurses having trained on the qualitative methods will conduct in-depth interviews. Whenever necessary, a separate data collecting female medical officer will conduct Tamil language interviews. Interviews will be carried out in a quiet place in the ward without disturbing the routine ward activities. The interviews will be conducted according to the Family Health International (FHI) guidelines [24] and other relevant texts available in the literature [25]. Whyte et al, in 1987 developed a six-point directiveness scale to help researches analyze their interviewing technique. The PI will go through the Whyte’s defectiveness scale [26] before conducting each interview and after the interview will analyze the interviewing technique using these criteria. As some informants are verbose than others, to maintain control of the interview, investigators will follow Patton’s strategies [27], the three strategies developed by Patton [1987] for maintaining control of the interview.

All interviews will be audio-recorded with consent to avoid transcription and translation errors. Field notes will be made during and immediately after the interviews. Each in-depth interview will last approximately 30–60 minutes. Data will be expanded immediately and transcribed within two weeks. Transcripts will be validated for accuracy by the local research team at CSHW and DSHW.

Methods to ensure trustworthiness and quality control of the qualitative components of the study

  1. The following steps will be taken to ensure the quality and trustworthiness of this study component. All data collection tools will be designed according to FHI guidelines [24].

  2. Triangulation minimizes bias due to chance associations and systematic biases due to a specific method in qualitative studies [28]. This will be achieved by comparison of data obtained through several in-depth interviews and different sources (postnatal mothers and several levels of HCP).

  3. Respondent validation which is considered as the strongest available check on the credibility of qualitative research [29] will be carried out as a participant checking in interviews.

  4. The quality of data collection will be maintained by using checklists in all field visits. Interviewers will be trained and supervised.

  5. To enhance reflexivity [29], a research diary will be maintained during data collection and analysis to document the assumptions, biases, and reactions to events occurring during the period of research and will discuss these issues in the presentation of the study. This will enable to express reflexivity of the study.

  6. Data collection and analysis methods will be done paying attention to rigor and transparency of the procedures.

  7. Investigators trained in qualitative analysis and knowledgeable on the concept of labour and childbirth will participate in data analysis. They will collectively perform the thematic analysis following independent coding and consensus and all authors will have consensus simultaneously to improve the credibility of the themes. When different opinions arise, these will be discussed among the three investigators and a consensus will be generated.

Quantitative phase

This will be the subsequent phase and data collection instruments will be modified according to the results of the qualitative phase. This phase will also be focused to describe the expectation- perception gap in respectful maternity care during labour and childbirth among women undergoing childbirth in CSHW and DSHW, Colombo, Sri Lanka.

Qualitative findings about RMC will be used for cognitive validation of the Women’s Perceptions of RMC (WP-RMC) local versions and the items in WP-RMC will be properly translated in a context-specific manner with aid of these qualitative inputs.

Inclusion and exclusion criteria for postnatal women in the quantitative phase

Inclusion criteria

  1. Age at least 18 years old or more at the time of delivery.

  2. All the vaginally delivered postnatal women with an uncomplicated antenatal period.

  3. Not known to have fetal anomalies.

Sample size calculation for the quantitative phase

The sample size will be calculated to assess the prevalence of disrespectful care using the formula for estimation of the proportion of a binary outcome;

n=Z2α2P(1P)d2

d -Margin of error = 0.05,

Z&/2–95% confidence interval,

P- Proportion (P) for disrespectful care as 0.7131. The overall pooled prevalence of disrespectful maternity care that was found in an Indian systematic review and meta-analysis was 71.31% [30]. The calculated sample size is 315 pregnant mothers. With an estimated 20% non-response rate, the final minimum sample size would be 378 participants. A higher non-response rate was chosen considering the sensitive nature of the problem that will be investigated in this vulnerable population.

Sampling method for the quantitative phase

There are five postnatal wards in CSHW and five in DSHW. Quota sampling will be conducted and approximately 40 vaginally delivered postnatal women with an uncomplicated antenatal period will be recruited from each of the 10 postnatal wards to yield the minimum sample size.

Participant recruitment, questionnaires and data collection procedure for the quantitative component

All the women will be given self-administered questionairre-01 [S3 File] and self-administered WP-RMC. Questionnaire 01 was prepared after reviewing the relevant literature and childbirth experience questionnaire [3133]and consists of 15 questions in a five-point Likert scale [‘Strongly agree’ to ‘Strongly disagree’] focusing on maternal opinion on various aspects of RMC. There were three questions about her sense of control, perception of pain and sense of security on a 1–10 visual analogue scale. This will be further modified using the results of the qualitative study. Face validation was done for the questionnaire with the participation of obstetricians, public health specialists. Pre-testing was conducted among a sample (n = 25) of postnatal women in another hospital.

The Iranian origin WP-RMC questionnaire is a recently developed, valid and a reliable tool to assess women’s perception regarding RMC amongst vaginally delivered women [34]. The tool is self-administered and contain 19 items. Among other tools available to assess women’s perception on RMC [3537] and patient centered care [20], the WP-RMC tool seems to be more robust since it’s development and validation has been conducted according to WHO RMC recommendations and a thorough review on the available literature on RMC [34]. Afulani et al have recently developed 27-item tool, person-centered maternity care scale to assess RMC in India and this is also another robust tool developed for this purpose [17,18]. However, WP-RMC is a relatively short, easy to understand hence can be administered in large scale. Therefore, investigators preference was to choose WP-RMC in the present study.

WP-RMC needs to be translated and validated into Sinhala and Tamil languages in the Sri Lankan context. For this purpose, the previously mentioned steps of translation and validation will be performed [38,39]. Initially the original English questionnaire will be translated into Sinhala and Tamil by a Sinhala and Tamil native accredited translators separately [forward translation]. This version will be reviewed by two separate Sinhala [native language] and Tamil [native language] obstetricians. The available items of the original tool will be modified, removed or new items may be added to culturally adapt the tool using the results of the initial qualitative component. This integration of qualitative findings is aimed to strengthen its cognitive validity.

Furthermore, WP-RMC Sinhala and Tamil versions will be given to 20 experts [obstetricians and public health specialists] and content validity index will be calculated. After necessary modifications by the experts, the final translations of Sinhala WP-RMC (WP-RMC-S) and Tamil WP-RMC (WP-RMC-T) will be produced. Internal consistency and test re-test reliability (administering the tool for 20 mothers from each ethnic group two weeks apart) of the tool will be assessed for both translations. Considering the 5–10 times the number of observed variables into the instrument, two samples of 190 women delivered vaginally at term will be recruited from Sinhala and Tamil speaking ethnicities separately for assessment of structural validity. The study settings will be selected according to the ethnic distribution of maternity ward admissions for each translations. Depending on the components of RMC, we will perform exploratory and/or confirmatory factor analysis to assess structural validity. Criterion validity of the WP-RMC-S and WP-RMC-T tools will be assessed with Edinburgh postnatal depression scale (EPDS). For structural validity of WP-RMC tools if data reduction is needed, exploratory factor analysis with maximum likelihood method using direct oblimin rotation will be conducted using SPSS.

Data analysis

The PI will initially familiarize himself by reading and re-reading the notes and transcripts. Three investigators will participate in data analysis. Two investigators will independently code data and a coding scheme will be developed and used to code all interview transcripts. The process will be conducted manually as data will be analyzed in the native language to minimize data loss.

As the dimensions of RMC are already identified, data analysis will include a framework approach [40]. However, initially thematic analysis will be conducted which will allow the authors to develop a rich thematic description regarding the issues around childbirth and labour experience. It will allow investigators to identify, analyze and report common themes with a minimum level of interpretation from the investigator [41]. The identified subthemes will be then fitted into the available frame work of RMC. As RMC is a new study area for the Sri Lankan context, the PI will be sensitive to and vigilant of new themes that could emerge apart from the available framework. The new themes will be added on consensus of the investigators.

The analytic process will include the following six steps given by Braun et al [42]. All steps need the consensus of all investigators.

  1. Preparing the transcript;

  2. Familiarizing data;

  3. Generating initial codes by marking words or sentences relevant to the topic of inquiry;

  4. From the codes, draft themes will be generated in an iterative process; independent coding will be performed by two investigators;

  5. The main categories and sub-categories of the themes will be identified;

  6. The results will be written up.

Statistical analysis of the validation part including assessment of the psychometric properties has been mentioned above. In the quantitative component, descriptive statistics and basic demographic characteristics of the quantitative data will be analyzed to see any deviations. Continuous variables with normal distributions will be presented as means with standard deviations. Discrete numeric variables and ordinal variables were presented as medians with inter-quartile ranges. Nominal and categorical variables will be presented as proportions. The expectation-perception gap will be described using relevant data analysis and presentation techniques. Significance will be declared at p-value <0.05. Standard statistical methods will be followed.

Duration of the study

The duration of the study will be approximately 12 months.

Data maintenance storage and disposal

Data will be entered into a data collection sheet and confidentially stored in an ongoing computer database.

Plan of presentation of results

Findings will be presented at academic symposia and published in indexed peer-reviewed journals.

Ethical considerations

Ethical approval was obtained from the Ethical Review Committee [ERC/256/05/2019], CSHW, Colombo, Sri Lanka.

Work plan and timelines

Currently ethics and administrative approvals have been obtained. Data collection is yet to be started soon and will take another four months. Data analysis and writing of the paper will take another three months approximately.

Strengths and limitations of the study

This research will add new knowledge to the existing literature filling an important research gap of RMC in LMIC settings. It will also lead to an increased understanding of a hidden area that has previously gained limited attention- the structural, cultural and social context behind the link between childbirth, mothers’ expectations and staff interactions in our setting. Collecting data at several levels and through triangulation between data sources, informant groups, and theories ensures comprehensiveness and quality of the data gathered. The mixed method approach will ensure rigor and quality of evidence generated from this study.

Considering the limited studies available, the poor attitudes [15] and high cesarean section rates in the country, this study will shed light on policy implementations with respect to quality maternal care in Sri Lanka. The findings would be beneficial for other LMICs with similar contexts and the culturally adapted tools could be used in similar settings to measure RMC. The study population will be limited to Colombo which is not generalizable into entire Sri Lanka making issues with its external validity.

Supporting information

S1 File. Interviewer guide for the postnatal mothers.

(PDF)

S2 File. Interviewer guide for the healthcare providers.

(PDF)

S3 File. English version of questionnaire-1 to assess socio demographic factors and expectations of RMC.

(PDF)

S4 File. Standards for Reporting Qualitative Research (SRQR) checklist [43].

(DOCX)

S5 File. Labour study ERC letter.

(PDF)

Data Availability

All relevant data from this study will be made available upon study completion.

Funding Statement

The author(s) received no specific funding for this work.

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Decision Letter 0

Marzia Lazzerini

25 Aug 2020

PONE-D-20-03776

Maternal and Healthcare Providers’ Perceptions of Quality of Care during Labour and Childbirth: Study Protocol for a Mixed-Methods Study.

PLOS ONE

Dear Dr. Patabendige,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Oct 02 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:

  • A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

  • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

  • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Marzia Lazzerini, PhD

Academic Editor

PLOS ONE

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. Please include a copy of the interview guide used in the study, in both the original language and English, as Supporting Information, or include a citation if it has been published previously.

3. Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed a questionnaire as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information.  If the original language is written in non-Latin characters, for example Amharic, Chinese, or Korean, please use a file format that ensures these characters are visible.

4. Please state whether you validated the questionnaire prior to testing on study participants. Please provide details regarding the validation group within the methods section.

5. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide.

6. Please include a caption for figure 1.

7. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

Additional Editor Comments (if provided):

Please read carefully the feedbacks from the referees and provide a point by point answer.

Please use the appropriate reporting guidelines checklists, such as STROBE and COREQ or SRQR (for qualitative research)

Please also specify if the study has been registered in any platform

Please also specify study timelines

[Note: HTML markup is below. Please do not edit.]

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: Partly

Reviewer #2: Yes

**********

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: Partly

**********

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

Reviewer #1: No

Reviewer #2: Yes

**********

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

**********

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: Yes

**********

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: The study protocol has the objective of exploring health professionals and women’s perceptions regarding the quality of care during labour and childbirth in Sri Lanka. This is an interesting project that would make an important contribution to the literature. I appreciated the opportunity to read the manuscript and specific comments are stated below.

First, the research questions are not clearly stated on last paragraphs of background section, but on lines 102-104 and 113-115; also, research questions are not in line with the following section: Objectives of the study (line 177). Please revise. I would suggest the use of reporting guidelines checklists, such as STROBE and COREQ or SRQR (for qualitative research). It would help to improve the hole paper comprehension. In addition, reference numbering is confusing and not organized in the order that articles were cited in the text (for example, in the first paragraph [lines 78-85] were cited references 8, 11 and 21). I recommend that the authors closely review and edit the paper.

Second, on methods would be helpful to provide more information regarding setting and specific hospital units described (example, well-baby clinic). I am assuming that De Soysa Hospital for Women (DSHW) should be also mentioned on lines 467 and 468, please review and edit if necessary.

Third, please clarify recruitment procedures. For example, for the qualitative phase: how representativeness of the sample will be monitored? For the quantitative phase, please consider that the sample size was calculated using “100% response rate” and this assumption is not supported by results of similar studies. In addition, exclusion criteria described for both women and health professionals during qualitative and quantitative phases are different throughout the manuscript (page 9 [lines 198-205] vs page 19 [lines 404-423]). Please revise and closely edit the section accordingly.

Fourth, authors described that "separate interview guides will be prepared for" health professionals and mothers, but the three additional files cited (line 274) were not available for review. Also, intended validation procedures (line 285) are not clearly described. Please provide more details of procedures, including references and additional files.

Finally, authors outlined as a limitation that the principal investigator are in the upper-level hierarchy of health professionals but they do not clearly specify if PI currently is working at DSHW and/or CSHW. Considering that all in-depth interviews will be conducted by the PI and the possibility of bias, in particular on health professionals’ results, would be helpful to provide few examples of planned mitigating actions to address this limitation.

Reviewer #2: The study hypothesis is certainly of high interest and originality in a context in which the quality of care in obstetrics is not only assessed on the basis of maternal and fetal-neonatal outcomes, but also on the basis of the "perceived" by the patient.

Nonetheless, although the study design is described in detail in the manuscript, I believe it is appropriate to streamline the background inherent the sub-chapters and the methods description because they look too reduntant. In this context I suggest to review the form of the manucript translating some topics from the "Backgorund" to the "Strengths and limitations" session

**********

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Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: 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.

PLoS One. 2021 May 5;16(5):e0250920. doi: 10.1371/journal.pone.0250920.r002

Author response to Decision Letter 0


22 Nov 2020

Editor’s comments

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. – Thank you. These changes were made in the manuscript in line 1-22.

2. Please include a copy of the interview guide used in the study, in both the original language and English, as Supporting Information, or include a citation if it has been published previously. – Thank you. These changes were made in the manuscript. S2,3,4 Files have been included in line 579-581.

3. Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed a questionnaire as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information.- – Thank you. These changes were made in the manuscript. S5 Files have been included in line 582. However, Part-4: FOBS was not added [we got it from a Sweden author-reference given] and it will be available upon a reasonable request. Two questions in FOBS has mentioned in the manuscript text [437-440]. WP-RMC tool was under copy right from the original authors (Ayoubi, Pazande et al 2020) and could not be included here.

4. Please state whether you validated the questionnaire prior to testing on study participants. Please provide details regarding the validation group within the methods section. – Thank you. These changes were made in the manuscript and detailed validation procedures mentioned in lines 424 for questionnaire-1, 446-469 for FOBS and WP-RMC in 474-498.

5. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide. - The data which will be gathered during this this study will be available upon a reasonable request from the corresponding author, not through the repository.

6. Please include a caption for figure 1. . – Thank you. These changes were made in the manuscript in line 175.

7. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. . – Thank you. These changes were made in the manuscript in lines 575-584.

8. Additional Editor Comments (if provided):

Please read carefully the feedbacks from the referees and provide a point by point answer. – Thank you. These changes were made in the manuscript and this cover letter.

Please use the appropriate reporting guidelines checklists, such as STROBE and COREQ or SRQR (for qualitative research) Thank you. This was added (SRQR).

Please also specify if the study has been registered in any platform – No, not registered.

Please also specify study timelines – Thank you. These changes were made in the manuscript and a Gantt chart added in lines 532 and 584 and Fig. 2 was also added for Gantt chart.

Reviewers' comments:

Reviewer 1

1. First, the research questions are not clearly stated on last paragraphs of background section, but on lines 102-104 and 113-115; also, research questions are not in line with the following section: Thank you. These changes were made in the manuscript and refer lines 137-141.

Objectives of the study (line 177). Please revise. Changes were added and in line 164-168. I would suggest the use of reporting guidelines. Checklists, such as STROBE and COREQ or SRQR (for qualitative research). It would help to improve the whole paper comprehension. - Thank you. These changes were made in the manuscript (SRQR was used).

In addition, reference numbering is confusing and not organized in the order that articles were cited in the text (for example, in the first paragraph [lines 78-85] were cited references 8, 11 and 21). I recommend that the authors closely review and edit the paper. -Thank you. These changes were made in the manuscript.

2. Second, on methods would be helpful to provide more information regarding setting and specific hospital units described (example, well-baby clinic). I am assuming that De Soysa Hospital for Women (DSHW) should be also mentioned on lines 467 and 468, please review and edit if necessary. -Thank you. These changes were made in the manuscript. DSHW is also mentioned in lines 186-189.

3. Third, please clarify recruitment procedures. For example, for the qualitative phase: how representativeness of the sample will be monitored?

-Thank you. Changes were made in the manuscript describing the representativeness. Included in lines 245-252.

“Participant recruitment will be done while maintaining a diversity to yield a good representativeness during sample selection. Pregnant and postnatal mothers will be recruited starting from uncomplicated cases, then instrumental delivery, elective/emergency caesarean delivery, awaiting a vaginal birth after caesarean (VABC), not willing for a VBAC in this pregnancy, maternal request for a caesarean, and mothers with a history of previous delivery in a different hospital and/or private sector accordingly. For HCP, representativeness will be maintained by selecting general labour ward staff to well-experienced ones, staff from units where labor companion is being practiced, and not being practiced at the moment.

During the initial introduction and discussion, if investigators feel that the relevant subject is not appropriate, interviewing will be abandoned and another subject will be selected. If the postnatal women are giving insufficient information while staying the hospital, postnatal interviews will be extended into the postnatal well-baby clinics where mothers are expected to give less socially desirable responses as they are not bound to the labour ward anymore. Recruiting and interviewing will be continued until the phenomena under the study are well understood and data saturation is reached”.

4. For the quantitative phase, please consider that the sample size was calculated using “100% response rate” and this assumption is not supported by results of similar studies.

-Thank you. These changes were made in the manuscript. Considering a 10% non-response rate, a final sample size of 355 was taken as mentioned in line 380.

In addition, exclusion criteria described for both women and health professionals during qualitative and quantitative phases are different throughout the manuscript (page 9 [lines 198-205] vs page 19 [lines 404-423]). Please revise and closely edit the section accordingly. -Thank you. These changes were made in the manuscript. Inclusion and exclusion criteria were corrected [lines 224-232 and 363-364].

4. Fourth, authors described that "separate interview guides will be prepared for" health professionals and mothers, but the three additional files cited (line 274) were not available for review. -Thank you. These changes were made in the manuscript and all the files attached as supporting information (S2,3,4 Files). See lines 579-580.

Also, intended validation procedures (line 285) are not clearly described. Please provide more details of procedures, including references and additional files. -Thank you. These changes were made in the manuscript under the quantitative phase for FOBS [lines 434-460] and WP-RMC scales [lines 446-469]. Refer the manuscript please for these lines as above.

5. Finally, authors outlined as a limitation that the principal investigator are in the upper-level hierarchy of health professionals but they do not clearly specify if PI currently is working at DSHW and/or CSHW. Considering that all in-depth interviews will be conducted by the PI and the possibility of bias, in particular on health professionals’ results, would be helpful to provide few examples of planned mitigating actions to address this limitation.

-Thank you. These changes were made in the manuscript. Several steps to reduce this effect were added to lines 559-566.

“PI being in the upper-level of hierarchy of HCP in CSHW has to be acknowledged as a limitation. However, a person with knowledge and experience on obstetric procedures is essential in interviewing as the areas indicate specific medical information and knowledge. Effect of PI will be less at DSHW as he is attached to the CSHW. Data collection by additional medical officers and nurses who are not directly involving with labour care in CSHW and DSHW will also minimize the effect of data collection solely by the PI. Since the study will be to conducted in two hospitals, this potential bias may be minimized with different working and interviewing sites of the investigators”.

Reviewer 2

1. Nonetheless, although the study design is described in detail in the manuscript, I believe it is appropriate to streamline the background inherent the sub-chapters and the methods description because they look too redundant. -Thank you. These changes were made in the manuscript and streamlined accordingly to paragraphs on importance of quality of maternity care, definition and domains of RMC, implications of RMC, Importance of RMC in the Sri Lankan context and justification, aims of the study [lines 79-169 and methods also streamlined].

2. In this context, I suggest to review the form of the manuscript translating some topics from the "Backgorund" to the "Strengths and limitations" session. -Thank you. These changes were made in the manuscript. Please refer the lines 536-554.

Thank you

Dr.Malitha Patabendige

Attachment

Submitted filename: point by point.docx

Decision Letter 1

Marzia Lazzerini

18 Jan 2021

PONE-D-20-03776R1

Maternal and healthcare providers’ perceptions on respectful maternity care: study protocol for a mixed-methods study.

PLOS ONE

Dear Dr. Patabendige,

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.

============================== 

In this second round of revisions two out of three independent referees recommended rejection. Please read carefully their comments before resubmitting. Please note that resubmission does not guarantee acceptance. 

==============================

Please submit your revised manuscript by Mar 04 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

  • A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

  • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

  • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

Kind regards,

Marzia Lazzerini, PhD

Academic Editor

PLOS ONE

Journal Requirements:

 Please check carefully Plos guidelines fore authors 

[Note: HTML markup is below. Please do not edit.]

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 #3: Partly

Reviewer #4: Yes

**********

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: No

Reviewer #3: No

Reviewer #4: Yes

**********

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

Reviewer #1: No

Reviewer #3: No

Reviewer #4: Yes

**********

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 #3: No

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: No

Reviewer #3: No

Reviewer #4: Yes

**********

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: The current version of the protocol has improved compared with the first one, but, some very important methodological issues were still not appropriately addressed by authors.

Regarding recruitment procedures, ii still not clear how both pregnant or postnatal women would be recruited by clinical characteristics (lines 246 to 250: “uncomplicated cases, instrumental delivery, elective/emergency caesarean delivery, awaiting a vaginal birth after caesarean (VABC), not willing for a VBAC in the current pregnancy, maternal request for a caesarean, and mothers with a history of previous delivery in a different hospital and/or private sector”) without prior access to medical records or privacy violations. For health care professionals, recruitment procedures described on manuscript are vague: it’s not clear the number of professional categories that would be invited to participate and in which proportion those categories will be present in the final sample. In addition, it’s not clear how the specification “units where labor companion is being practiced and not being practiced at the moment” would influence health workers sample size or composition.

Regarding interviews, it is still not clear how interviewer guides both for pregnant/mothers and health care professionals should be used. The documents provided as supplementary files are poor detailed and difficult to be used in a standardized way without additional instructions. Also, the criteria (why and how) “interviewing will be abandoned” (lines 254 and 255) or “extended into postnatal well-baby clinics” (line 257) is very subjective and not clear described on manuscript (add a selection bias for complete interviews?). I also recommend to provide a reference about the “framework approach” that will be used to analyze interviews content (lines 296 and 301) and to provide the checklist file that will be used for quality control of qualitative phase (lines 328-329).

Regarding assessment tools, the questionnaire 1 (intended to collect “maternal opinion on mode of delivery and childbirth”) should be validated in a sample of mothers. According to authors (lines 423-425) the face validity was done “with the participation of obstetricians, public health specialists”. The proposed use of questionnaire 3 (WP-RMC) “for women who were admitted to the labour suite irrespective of mode of delivery” is not in accordance with the original reference n.30 and it’s not clear how further modifications will be performed (lines 486-487). In addition, in line 409 seems that the publication cited on reference number 30 is about Sri Lanka protocol (“changes accepted by the original authors of WP-RMC in Iran (30)”).

The quality of the English throughout the manuscript would be improved by asking a native English-speaking to review the text. The lack of a market copy of the manuscript among the files uploaded by authors have made difficult the review of this version of the manuscript.

Reviewer #3: This manuscript, “Maternal and healthcare providers’ perceptions on respectful maternity care: study

protocol for a mixed-methods study,” describes a planned observational study to use interviews with obstetric patients and providers and interview-led obstetric patient survey assessment of the Fear of Birth Scale to improve understanding of respectful obstetric care in Colombo, Sri Lanka.

First and foremost, I commend the study team for designing a study to help address the very important problem of disrespectful obstetric care, which has been overlooked in much of the world, particularly South Asia. However, I think there is substantial room for improvement in the study design and writing of the paper.

Major concerns:

1) Utility of designing a new obstetric care scale for patients, and based off a scale designed in Sweden. Why not use an existing tool, such as this one that has been validated in India and now used prolifically? Afulani PA, et al. Validation of the person-centered maternity care scale in India. Reproductive Health 2018;15(147). Other major papers in this field are missing, such as https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5764229/ The authors write, “Currently, there are tools have developed to measure the women’s expectations of RMC in global literature.” I think the authors mean no tools, which is untrue. Also the incorrect English of this sentence and throughout the paper really makes it hard to follow, although I am sympathetic to English not being the team’s first language.

2) I have serious concerns about the validity of the interviews. On the provider side, very little detail is given and it’s unclear what is expected to be found. The paper cites a prior study of “poor attitudes” of Sri Lankan obstetricians of allowing labor companions, which is a standard component of respectful maternity care. On the patient side, I strongly disagree that the PI, a male authority figure tied to the women’s care, is the appropriate person to lead all patient interviews and I think it will lead to inaccurate interviews with patients. I strongly think they should be led by a female who is not a healthcare provider – ideally a mother and someone of the same ethnicity.

3) The paper is quite hard to follow – it could be much better organized and I think the reviewer comments could have been more fully addressed.

Specific comments:

Title: Is confusing – I thought when I first read it that this study was about obstetric providers’ perceptions of respectful maternity care. Suggested rephrase to “Perceptions on respectful maternity care in Sri Lanka: Study protocol for a mixed-method study of patients and providers.”

Introduction: Authors conflate “disrespectful maternity care” and “obstetric violence,” which the introduction largely talks about. The Introduction is long and not well focused (4 pages). I would devote more text to the specific Colombo setting. (Example, why is this study needed in addition to obstetric violence and obstetric patient experience studies that have been done in India and other LMICs?)

Qualitative aim: Besides issues mentioned above, I think the study should just interview women postpartum during delivery hospitalization. It does not make sense to interview women hospitalized for delivery who have not yet delivered. HCP is not well defined. I do not agree with only including healthy women with healthy babies – much is to be learned about the experiences of women when complications arise. Unclear why purposive sampling and what is meant by the investigator will “abandon” the interview if he decides the subject is “not appropriate.” This opens up substantial risk of selection bias. Very little detail on the HCP interviews.

Quantitative aim: This aim is overall confusing. I think that the FOBS from the Swedish study will be adapted based on the interviews? In the power calculation, it says the main outcome is “fear of birth” but I have no idea who is being compared. I don’t follow the analysis plan – it’s very vague.

Reviewer #4: PLOS ONE

Maternal and healthcare providers’ perceptions on respectful maternity care: study

protocol for a mixed-methods study.

Manuscript Number: PONE-D-20-03776R1

Article Type: Registered Report Protocol

Full Title: Maternal and healthcare providers’ perceptions on respectful maternity care: study

protocol for a mixed-methods study.

Summary and Impression

This is a research protocol report describing a mixed methods study design for analyzing RMC in Sri Lanka. The report lays out in detail the steps needed to understand and replicate the methods the authors are using. The design of the study answers the study question and contributes new knowledge to the maternal health community.

Major Issues

Major issues were identified during the prior revisions.

Minor Issues

Page 4, Line 96-98. The final two sentences of the paragraph do not flow with the material. Unless there is to be a larger discussion of the global caesarean epidemic, I recommend that both of these sentences can be removed.

Page 6, Line 137-141. This paragraph can be removed and if needed, a summative, single addition added to the list in the prior paragraph’s final sentence.

Page 10, Line 223 (and inclusion criteria overall). Are you unnecessarily limiting the scope of your sample by only including “Birth of a live healthy baby.” If RMC influences outcomes for mothers and newborns, including either newborns with complications or who died during/post-delivery may have substantial value. Please explain your rational for this inclusion criteria in the paper.

Page 10, Line 229. Please provide the rational for excluding HCWs with <1 year of obstetric experience. HCWs with less experience in obstetrics may have an informative viewpoint.

Page 11, Line 256 (and other locations in abstract/text). Please explain how you will identify socially desired responses, if responses are being influenced by the location. Limited responses should be relatively straightforward to detect but responses being influenced by the location more challenging.

Page 12, Line 273. Please make explicit what from the previous items that the “This” is that will minimize potential bias.

Page 13, Line 292. Will all data be independently coded by 2 investigators? Later in the manuscript it seems like it will however, this should be clarified here and how any disagreements will be resolved.

Page 13, Line 308-314. The citation is enough, and you can remove the list.

Page 14, Linen 319-320. The first sentence is repetitive with subsection title and not needed.

Page 14, Line 328. Add brief statement on how the interview guides and note-taker forms will be pretested.

Page 14, Line 335-336. #6 does not have detail and therefore does not add value. Suggest removing.

Page 15, Line 356-360. Inclusion criteria for the quantitative phase. Are women not able to read sufficiently, excluded from the quantitative portion as two parts are self administered. If so, please add to Limitations. If not, please explain how this will be handled.

Page 16, Line 377. Typo please correct (Z&)

Page 16, Line 380. Please provide a reference if available to the anticipated 10% non-response rate. This seems low for this vulnerable population.

Page 21, Line 486-. Translation is described repeatedly in the manuscript. This may be better consolidated into a single area in the methods section for brevity.

Page 23, Line 537. Please succinctly state what the research gap is specifically.

Page 24, Line 559. The line “However, proving proper information might reduce this” is unclear.

Page 23-24. Limitations. Is having a male interviewer a potential limitation? Should this be explicitly stated?

Overall, please check carefully for typos and grammar.

**********

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: No

Reviewer #4: Yes: Matthew C. Strehlow

[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.]

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Attachment

Submitted filename: PLOS ONE RMC Review 12 2020.docx

PLoS One. 2021 May 5;16(5):e0250920. doi: 10.1371/journal.pone.0250920.r004

Author response to Decision Letter 1


6 Mar 2021

PLOS ONE

Perceptions on respectful maternity care in Sri Lanka: Study protocol for a mixed-methods study of patients and providers.

Manuscript Number: PONE-D-20-03776R1

Article Type: Registered Report Protocol

My sincere gratitude goes to the editors and reviewers for their generous effort in improving this manuscript. All the comments raised by the editors and reviewers have been addressed point by point.

Thank you

Dr.Malitha Patabendige

Reviewer #1:

The current version of the protocol has improved compared with the first one, but, some very important methodological issues were still not appropriately addressed by authors.

Regarding recruitment procedures, ii still not clear how both pregnant or postnatal women would be recruited by clinical characteristics (lines 246 to 250: “uncomplicated cases, instrumental delivery, elective/emergency caesarean delivery, awaiting a vaginal birth after caesarean (VABC), not willing for a VBAC in the current pregnancy, maternal request for a caesarean, and mothers with a history of previous delivery in a different hospital and/or private sector”) without prior access to medical records or privacy violations.

– Thank you, these controversial issues have been addressed.

For health care professionals, recruitment procedures described on manuscript are vague: it’s not clear the number of professional categories that would be invited to participate and in which proportion those categories will be present in the final sample. In addition, it’s not clear how the specification “units where labor companion is being practiced and not being practiced at the moment” would influence health workers sample size or composition.

– Thank you, these controversial issues have been addressed. Details have been included about the HCP and how to deal with units without labour companionship.

Regarding interviews, it is still not clear how interviewer guides both for pregnant/mothers and health care professionals should be used. The documents provided as supplementary files are poor detailed and difficult to be used in a standardized way without additional instructions.

– Thank you, these controversial issues have been addressed. I personally contacted Prof.Afulani and went through her interview guides and learnt a lot to improve interviewer guides.

Also, the criteria (why and how) “interviewing will be abandoned” (lines 254 and 255) or “extended into postnatal well-baby clinics” (line 257) is very subjective and not clear described on manuscript (add a selection bias for complete interviews?).

– Thank you, these controversial issues have been addressed and removed.

I also recommend to provide a reference about the “framework approach” that will be used to analyze interviews content (lines 296 and 301) and to provide the checklist file that will be used for quality control of qualitative phase (lines 328-329).

– Thank you, these controversial issues have been addressed. References provided.

Regarding assessment tools, the questionnaire 1 (intended to collect “maternal opinion on mode of delivery and childbirth”) should be validated in a sample of mothers. According to authors (lines 423-425) the face validity was done “with the participation of obstetricians, public health specialists”. The proposed use of questionnaire 3 (WP-RMC) “for women who were admitted to the labour suite irrespective of mode of delivery” is not in accordance with the original reference n.30 and it’s not clear how further modifications will be performed (lines 486-487). In addition, in line 409 seems that the publication cited on reference number 30 is about Sri Lanka protocol (“changes accepted by the original authors of WP-RMC in Iran (30)”).

– Thank you, these controversial issues have been addressed. Pre-testing of questionnaire 01 among a sample of 25 postnatal women has been done.

The quality of the English throughout the manuscript would be improved by asking a native English-speaking to review the text. The lack of a market copy of the manuscript among the files uploaded by authors have made difficult the review of this version of the manuscript.

– Thank you, copy with tracked-changes has been attached for your reference.

Reviewer #3:

This manuscript, “Maternal and healthcare providers’ perceptions on respectful maternity care: study protocol for a mixed-methods study,” describes a planned observational study to use interviews with obstetric patients and providers and interview-led obstetric patient survey assessment of the Fear of Birth Scale to improve understanding of respectful obstetric care in Colombo, Sri Lanka.

First and foremost, I commend the study team for designing a study to help address the very important problem of disrespectful obstetric care, which has been overlooked in much of the world, particularly South Asia. However, I think there is substantial room for improvement in the study design and writing of the paper.

Major concerns:

1) Utility of designing a new obstetric care scale for patients, and based off a scale designed in Sweden. Why not use an existing tool, such as this one that has been validated in India and now used prolifically? Afulani PA, et al. Validation of the person-centered maternity care scale in India. Reproductive Health 2018;15(147). Other major papers in this field are missing, such as https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5764229/ The authors write, “Currently, there are tools have developed to measure the women’s expectations of RMC in global literature.” I think the authors mean no tools, which is untrue. Also the incorrect English of this sentence and throughout the paper really makes it hard to follow, although I am sympathetic to English not being the team’s first language.

– Thank you, these important issues have been addressed. References have been added. Justification has provided why we prefer Iranian tool- WP-RMC. We have also acknowledged the value of important work by Afulani et al on RMC.

2) I have serious concerns about the validity of the interviews. On the provider side, very little detail is given and it’s unclear what is expected to be found. The paper cites a prior study of “poor attitudes” of Sri Lankan obstetricians of allowing labor companions, which is a standard component of respectful maternity care. On the patient side, I strongly disagree that the PI, a male authority figure tied to the women’s care, is the appropriate person to lead all patient interviews and I think it will lead to inaccurate interviews with patients. I strongly think they should be led by a female who is not a healthcare provider – ideally a mother and someone of the same ethnicity.

– Thank you, we agree with your concerns and a female group of data collectors was included. Details added for the providers’ side.

3) The paper is quite hard to follow – it could be much better organized and I think the reviewer comments could have been more fully addressed.

- Thank you, the entire manuscript was re-written and completely changed.

Specific comments:

Title: Is confusing – I thought when I first read it that this study was about obstetric providers’ perceptions of respectful maternity care. Suggested rephrase to “Perceptions on respectful maternity care in Sri Lanka: Study protocol for a mixed-method study of patients and providers.”

- Thank you, we have changed the title as suggested.

Introduction: Authors conflate “disrespectful maternity care” and “obstetric violence,” which the introduction largely talks about. The Introduction is long and not well focused (4 pages). I would devote more text to the specific Colombo setting. (Example, why is this study needed in addition to obstetric violence and obstetric patient experience studies that have been done in India and other LMICs?)

- Sri Lanka is a unique setting among other LMIC, so then Colombo setting has been justified.

Qualitative aim: Besides issues mentioned above, I think the study should just interview women postpartum during delivery hospitalization. It does not make sense to interview women hospitalized for delivery who have not yet delivered. HCP is not well defined. I do not agree with only including healthy women with healthy babies – much is to be learned about the experiences of women when complications arise.

- Thank you, we have included only the vaginally delivered postnatal women. Women who had complications also included. HCP and the aims were defined.

Unclear why purposive sampling and what is meant by the investigator will “abandon” the interview if he decides the subject is “not appropriate.” This opens up substantial risk of selection bias. Very little detail on the HCP interviews.

- Thank you, these have been addressed completely. Controversial points [investigator will “abandon” the interview if he decides the subject is “not appropriate] have been removed.

Quantitative aim: This aim is overall confusing. I think that the FOBS from the Swedish study will be adapted based on the interviews? In the power calculation, it says the main outcome is “fear of birth” but I have no idea who is being compared. I don’t follow the analysis plan – it’s very vague.

- Thank you, we have removed the FOBS from the protocol and focused only on the RMC. Accordingly, analysis plan was made clear.

Reviewer #4: PLOS ONE

Maternal and healthcare providers’ perceptions on respectful maternity care: study protocol for a mixed-methods study.

Summary and Impression

This is a research protocol report describing a mixed methods study design for analyzing RMC in Sri Lanka. The report lays out in detail the steps needed to understand and replicate the methods the authors are using. The design of the study answers the study question and contributes new knowledge to the maternal health community.

Major Issues

Major issues were identified during the prior revisions.

- Thank you.

Minor Issues

Page 4, Line 96-98. The final two sentences of the paragraph do not flow with the material. Unless there is to be a larger discussion of the global caesarean epidemic, I recommend that both of these sentences can be removed.

- Thank you, we have addressed these issues and the manuscript was updated accordingly.

Page 6, Line 137-141. This paragraph can be removed and if needed, a summative, single addition added to the list in the prior paragraph’s final sentence.

- Thank you, we have addressed these issues and the manuscript was updated accordingly.

Page 10, Line 223 (and inclusion criteria overall). Are you unnecessarily limiting the scope of your sample by only including “Birth of a live healthy baby.” If RMC influences outcomes for mothers and newborns, including either newborns with complications or who died during/post-delivery may have substantial value. Please explain your rational for this inclusion criteria in the paper.

- Thank you, we have addressed these issues and the manuscript was updated accordingly. Women with complications also added.

Page 10, Line 229. Please provide the rational for excluding HCWs with <1 year of obstetric experience. HCWs with less experience in obstetrics may have an informative viewpoint.

- Thank you, we have addressed these issues and the manuscript was updated accordingly. They have also included.

Page 11, Line 256 (and other locations in abstract/text). Please explain how you will identify socially desired responses, if responses are being influenced by the location. Limited responses should be relatively straightforward to detect but responses being influenced by the location more challenging.

- Thank you, we have addressed these issues and the manuscript was updated accordingly. This could be a limitation.

Page 12, Line 273. Please make explicit what from the previous items that the “This” is that will minimize potential bias.

- Thank you, we have addressed these issues and the manuscript was updated accordingly. Controversial points removed.

Page 13, Line 292. Will all data be independently coded by 2 investigators? Later in the manuscript it seems like it will however, this should be clarified here and how any disagreements will be resolved.

- Thank you, we have addressed these issues and the manuscript was updated accordingly.

Page 13, Line 308-314. The citation is enough, and you can remove the list.

Page 14, Linen 319-320. The first sentence is repetitive with subsection title and not needed.

Page 14, Line 328. Add brief statement on how the interview guides and note-taker forms will be pretested.

- Thank you, we have addressed these issues and the manuscript was updated accordingly.

Page 14, Line 335-336. #6 does not have detail and therefore does not add value. Suggest removing.

Page 15, Line 356-360. Inclusion criteria for the quantitative phase. Are women not able to read sufficiently, excluded from the quantitative portion as two parts are self-administered. If so, please add to Limitations. If not, please explain how this will be handled.

- Thank you, we have addressed these issues and the manuscript was updated accordingly.

Page 16, Line 377. Typo please correct (Z&)

Page 16, Line 380. Please provide a reference if available to the anticipated 10% non-response rate. This seems low for this vulnerable population.

Page 21, Line 486-. Translation is described repeatedly in the manuscript. This may be better consolidated into a single area in the methods section for brevity.

- Thank you, we have addressed these issues and the manuscript was updated accordingly.

Page 23, Line 537. Please succinctly state what the research gap is specifically.

Page 24, Line 559. The line “However, proving proper information might reduce this” is unclear.

Page 23-24. Limitations. Is having a male interviewer a potential limitation? Should this be explicitly stated?. Overall, please check carefully for typos and grammar.

- Thank you, we have addressed these issues and the manuscript was updated accordingly.

Attachment

Submitted filename: PLOS ONE RMC point by point Review Feb 28 2020.docx

Decision Letter 2

Tanya Doherty

19 Apr 2021

Perceptions on respectful maternity care in Sri Lanka: Study protocol for a mixed-methods study of patients and providers.

PONE-D-20-03776R2

Dear Dr. Patabendige,

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,

Tanya Doherty, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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 #3: Yes

**********

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 #3: Yes

**********

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

Reviewer #3: Yes

**********

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 #3: 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 #3: Yes

**********

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 #3: I am satisfied with the changes made in response to the reviewer comments. I have no further comments to add at this point.

**********

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 #3: No

Acceptance letter

Tanya Doherty

23 Apr 2021

PONE-D-20-03776R2

Perceptions on respectful maternity care in Sri Lanka: Study protocol for a mixed-methods study of patients and providers.

Dear Dr. Patabendige:

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 Tanya Doherty

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 File. Interviewer guide for the postnatal mothers.

    (PDF)

    S2 File. Interviewer guide for the healthcare providers.

    (PDF)

    S3 File. English version of questionnaire-1 to assess socio demographic factors and expectations of RMC.

    (PDF)

    S4 File. Standards for Reporting Qualitative Research (SRQR) checklist [43].

    (DOCX)

    S5 File. Labour study ERC letter.

    (PDF)

    Attachment

    Submitted filename: point by point.docx

    Attachment

    Submitted filename: PLOS ONE RMC Review 12 2020.docx

    Attachment

    Submitted filename: PLOS ONE RMC point by point Review Feb 28 2020.docx

    Data Availability Statement

    All relevant data from this study will be made available upon study completion.


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