Bohren et al. BMC Medical Research Methodology (2018) 18:132 https://doi.org/10.1186/s12874-018-0603-x RESEARCH ARTICLE Open Access Methodological development of tools to measure how women are treated during facility-based childbirth in four countries: labor observation and community survey Meghan A. Bohren1,2* , Joshua P. Vogel1, Bukola Fawole3, Ernest T. Maya4, Thae Maung Maung5, Mamadou Diouldé Baldé6,7, Agnes A. Oyeniran8, Modupe Ogunlade8, Kwame Adu-Bonsaffoh9, Nwe Oo Mon5, Boubacar Alpha Diallo6,7, Abou Bangoura6,10, Richard Adanu4, Sihem Landoulsi1, A. Metin Gülmezoglu1 and Özge Tunçalp1 Abstract Background: Efforts to improve maternal health are increasingly focused on improving the quality of care provided to women at health facilities, including the promotion of respectful care and eliminating mistreatment of women during childbirth. A WHO-led multi-country research project aims to develop and validate two tools (labor observation and community survey) to measure how women are treated during facility-based childbirth. This paper describes the development process for these measurement tools, and how they were implemented in a multi- country study (Ghana, Guinea, Myanmar and Nigeria). Methods: An iterative mixed-methods approach was used to develop two measurement tools. Methodological development was conducted in four steps: (1) initial tool development; (2) validity testing, item adjustment and piloting of paper-based tools; (3) conversion to digital, tablet-based tools; and (4) data collection and analysis. These steps included systematic reviews, primary qualitative research, mapping of existing tools, item consolidation, peer review by key stakeholders and piloting. Results: The development, structure, administration format, and implementation of the labor observation and community survey tools are described. For the labor observations, a total of 2016 women participated: 408 in Nigeria, 682 in Guinea, and 926 in Ghana. For the community survey, a total of 2672 women participated: 561 in Nigeria, 644 in Guinea, 836 in Ghana, and 631 in Myanmar. Of the 2016 women who participated in the labor observations, 1536 women (76.2%) also participated in the community survey and have linked data: 779 in Ghana, 425 in Guinea, and 332 in Nigeria. (Continued on next page) * Correspondence: meghan.bohren@unimelb.edu.au 1UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, 1211 Geneva, Switzerland 2Gender and Women’s Health Unit, Centre for Health Equity, Melbourne School of Population and Global Health, The University of Melbourne, Carlton, VIC 3053, Australia Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 2 of 15 (Continued from previous page) Conclusions: An important step to improve the quality of maternity care is to understand the magnitude and burden of mistreatment across contexts. Researchers and healthcare providers in maternal health are encouraged to use and implement these tools, to inform the development of more women-centered, respectful maternity healthcare services. By measuring the prevalence of mistreatment of women during childbirth, we will be able to design and implement programs and policies to transform maternity services. Keywords: Maternal health, Obstetric delivery, Childbirth, Quality of care, Mistreatment, Disrespect and abuse, Nigeria, Ghana, Guinea, Myanmar Background [7]. Since then, WHO published a statement in 2014 Worldwide, an estimated 303,000 maternal deaths occurred calling for the “Prevention and elimination of disrespect in 2015, 99% of which were in low- and middle-income and abuse during childbirth,” which has been endorsed countries (LMIC) [1]. Efforts to improve maternal by over 90 organizations worldwide [8]. A 2015 publi- health have historically focused on increasing the rate cation by Bohren and colleagues proposed a typology and coverage of antenatal care, skilled birth attendance, for the mistreatment of women during childbirth, based and births occurring in health facilities. However, there on a mixed-methods systematic review that included is a growing focus on the importance of ensuring good evidence from 65 studies conducted in 34 countries [5]. quality maternal healthcare to improve health outcomes. This work proposed that the mistreatment of women In 2015, the World Health Organization (WHO) proposed during childbirth includes physical and verbal abuse, a global vision where ‘every pregnant woman and new- discrimination, neglect, and health systems constraints born receives quality care throughout pregnancy, child- [5], which can amount to human rights violations [9]. birth and the postnatal period’ [2], and highlighted the The mistreatment of women during childbirth is a importance of considering both how care is provided by multidimensional issue that requires understanding of health workers within health systems, and how care is ex- complex social norms related to gender equality, power perienced by users (particularly pregnant women and their dynamics, and clinical hierarchies [10, 11]. families). The WHO framework for quality of care expli- citly identifies effective communication, respect, dignity, and emotional support as key domains of quality to im- Mistreatment within the context of women’s health prove women’s and newborns’ experiences of care [2]. globally Quality of care has been further emphasized by the The Sustainable Development Goal (SDG) era presents 2018 “WHO recommendations on intrapartum care for the global community with an exciting opportunity to im- a positive childbirth experience,” that extend beyond the prove health, well-being and equality for all women. SDG prevention of mortality and morbidity to encompass a 3 includes targets to continue the reduction of the mater- woman-centered, rights-based approach to optimizing nal mortality ratio and ensure universal access to sexual health and well-being for women and their babies [3, 4]. and reproductive health care services [12]. Relatedly, SDG The new recommendations articulate the overarching 5 targets include ending all forms of discrimination, importance of respectful maternity care, and the need violence, and harmful practices against women and girls for staff and health services to create enabling maternity [12]. Similarly, the Global Strategy for Women’s, Chil- care environments that encourage a woman’s sense of dren’s and Adolescents’ Health was launched by the control and their involvement in decision-making [3]. It United Nations in 2015 and outlines an ambitious ap- also contains specific recommendations on respectful proach to end preventable deaths (survive), ensure health care policies, labor companionship and effective com- and well-being (thrive), and expand enabling environ- munication. These recommendations reflect a growing ments (transform), while leaving no one behind [13]. The body of literature demonstrating that women may ex- Global Strategy seeks to ensure that all women not only perience abusive, neglectful or disrespectful care during survive childbirth and any complications if they arise, but labor and childbirth in healthcare facilities [5]. These that all women can reach their full potential for life and negative experiences may inhibit women from attending health. These goals promote a global landscape where re- health facilities for childbirth, or using them in the fu- ducing health and gender inequalities, and promoting ture [6]. positive healthcare experiences are paramount to trans- In 2010, Bowser and Hill published a landscape ana- form our world. Eliminating all forms of mistreatment of lysis outlining the issue of disrespectful and abusive care women during childbirth is a critical pathway to achieve women experienced during childbirth in health facilities these goals and transform society. Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 3 of 15 Measuring the mistreatment of women during childbirth women during childbirth that would provide comparable Bowser and Hill’s landscape analysis spurred the conduct data of the burden of mistreatment across settings. In of several research projects on measuring disrespect and 2014 WHO initiated a multi-country research study en- abuse during childbirth, including studies in Kenya, titled “How women are treated during facility -based Tanzania, Nigeria, and Ethiopia [14–25]. These studies childbirth: development and validation of measurement were informed by the definitions and categories pro- tools in four countries” [29]. The primary objectives of posed by Bowser and Hill. However data collection this study were to develop an evidence-based definition methods and tools varied, including direct observations and associated set of identification criteria for the mis- of labor and childbirth [21], facility exit interviews with treatment of women during childbirth in facilities, and women [14, 18, 24, 26], and interviews with women dur- two tools to measure this phenomenon. A two-phased, ing the postpartum period [24–26]. Prevalence estimates mixed-methods study design was used to develop identifi- vary widely between individual studies (12.2 to 98% cation criteria and tools for measuring mistreatment in fa- across studies conducted in LMIC settings), which is at cilities, and understand influencing factors in Ghana, least partly due to these methodological differences. Guinea, Myanmar and Nigeria. Phase 1 was a formative Sando and colleagues reviewed the methods used in five phase comprised of a mixed-methods systematic review prevalence studies, identifying several key differences be- on mistreatment [5], a qualitative evidence synthesis on tween measurement approaches [27]. A standard ap- respectful maternity care [30], and primary qualitative re- proach to defining and measuring mistreatment of search (focus group discussions, in-depth interviews) in women during childbirth, through the development of four countries [10, 29, 31–34]. Findings from Phase 1 in- validated measurement tools, would therefore permit formed the measurement component (Phase 2), which standardized comparisons of prevalence data across set- used direct observations of labor and childbirth in health tings and over time. facilities, and follow-up community-based surveys with postpartum women to measure mistreatment during childbirth. This paper describes the development of the Rationale for terminology two measurement tools and how they were implemented Different terminologies have been used to describe the in the study sites. Providing this detailed description can phenomenon of mistreatment during childbirth, in- help users to understand the robust and systematic devel- cluding obstetric violence, disrespect and abuse, and opment process that was used, and can help inform tool respectful maternity care. For the purposes of our development in related areas. study, we have used the term “mistreatment of women during childbirth” to convey the phenomenon of inter- est in a way that places the woman at the center of the experience, e.g. to promote a woman-centered meas- Methods urement approach. This terminology uses language An iterative mixed-methods approach was used to de- that does not assign blame, which has helped us to velop two measurement tools: direct observations of labor form multidisciplinary teams of women, researchers, and childbirth, and a follow-up community-based survey midwives, nurses, doctors and healthcare administra- with women. Methodological development was conducted tors, and reduced the risk of alienating certain groups in four steps (Fig. 1): (1) initial tool development; (2) valid- by passing judgment through vocabulary. Further- ity testing, item adjustment and piloting of paper-based more, we believe that this terminology acknowledges tools; (3) conversion to digital, tablet-based tools; and (4) that mistreatment may occur either intentionally or data collection. Several research methods were employed, non-intentionally, may result from shortcomings in including systematic reviews, primary qualitative research, the health system rather than malicious intent, and mapping of existing tools, item consolidation, peer review may be experienced either at an intrapersonal level be- by key stakeholders and piloting, and are described in the tween a woman and a healthcare provider or staff, or following sections. at a more nuanced level during a woman’s interactions with the health system and infrastructure [28]. Step 1: Initial tool development (June 2014 to December 2015) The WHO multi-country study: “How women are treated The overall aim of these tools is to be discriminative; that is during facility-based childbirth” to distinguish women who experience mistreatment during In November 2013, a technical consultation of inter- childbirth, from those who do not. The multi-country re- national experts recommended that WHO initiate advo- search team discussed and agreed on desired characteristics cacy and research activities to develop and validate of the measurement tools, which informed the study design prevalence measurement tools on the mistreatment of (Table 1). Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 4 of 15 Fig. 1 Visual depiction of the tool development process Identification of domains and items: Evidence synthesis and existing measurement tools. In some instances, tools formative research related only to a subset of domains/items within the The evidence-based typology from the systematic review by typology. Bohren and colleagues provided the initial tool structure Through this process we identified 36 tools [14, 18, and domains [5]. This typology was further informed by 21–25, 35–63]. All identified tools were reviewed, and findings from the primary qualitative research in four coun- relevant items were mapped to the corresponding do- tries (Ghana, Guinea, Myanmar and Nigeria) with women, mains of mistreatment. For some domains (such as providers and administrators [10, 31–34], to provide illus- consenting for vaginal examinations), there were no trative quotes of specific themes and sub-themes to inform existing items, or existing items were unsuitable for use development of tool items (i.e. questions). The research in this study. Resulting from this process was a system- team developed an initial list of potential items through dis- atic mapping of existing items against the domains of cussion and consensus. mistreatment identified in the systematic review. The research team then used a consensus process to de- Identification of domains and items: Review of existing velop two draft tools based on available items. In some measurement tools domains (such as types of physical and verbal mistreat- Tools and specific items have been developed and ap- ment), item reduction or consolidation was required. The plied in several recent studies that relate to aspects of labor observation tool and community survey tool were how women are treated during childbirth. We identified harmonized to the extent possible on a per-domain and relevant existing tools through a) measurement studies per-item basis, to allow comparisons between data col- identified via the mixed-methods systematic review [5], lected using the two tools. and b) contacting key stakeholders working in maternal and perinatal health research and quality of maternity Step 2: Validity testing, item adjustment and piloting of care (including those working on issues of respect, paper-based tools (January to April 2016) dignity and mistreatment during childbirth) to share any During this step, we aimed to optimize the two tools for: Table 1 Desired characteristics of the study design and 1. Content validity: to assess if the proposed tools measurement tools were measuring all aspects of the construct of a Phenomena of interest Occurrence of mistreatment of women during woman’s experience of mistreatment, and to labor, childbirth, and immediate postpartum identify any additional items that should be period in health facilities considered for inclusion [64]; and Target population Women giving birth in participating health 2. Understandability: To ensure the clarity of wording, facilities in study countries likelihood that participants and users could answer Time period of interest From admission to health facility for the questions, and a user-friendly layout and style childbirth, until 2 h postpartum in the health facility or discharge, whichever happens first. Administration format Tool #1 –direct observation of women Validity testing with maternal health experts during labor, childbirth, and immediate We facilitated a meeting with seven global maternal health postpartum content experts to review draft versions of both tools. Tool #2 – an interviewer-administered survey of postpartum women’s self-reported Using a structured approach, these experts were asked to experiences of how they were treated during comment on how relevant each item is to the construct it childbirth in a health facility conducted is designed to measure. Experts were also asked to com- several weeks postpartum ment on item clarity and conciseness, as well as suggest Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 5 of 15 items that may have been missed. Field notes were concepts. Several items were added or adjusted based on taken during the discussion to capture key points, and feedback, such as integrating newborn care practices feedback was incorporated into the tool structure and into the labor observation tool, and ensuring that mater- contents. Key revisions from this step centered around nal health outcome items were articulated in a way that prioritizing items related to maternal and newborn a non-clinician could understand. Final decisions regard- health outcomes, such as which items were feasible and ing tool structure and items were made through research reliable to ask a woman during the community survey, team consensus. and which items were feasible and reliable to have a non-clinical research assistant assess during the labor Piloting paper-based tools observations. Furthermore, the expert group and re- The revised tools were formally piloted in one study site search team discussed in detail how to document in- in Nigeria. Two female researchers from the Nigeria team stances of mistreatment during the labor observations, (AAO and MO) conducted direct observations of a con- focusing on whether the research priority was to docu- venience sample of twenty consenting women throughout ment either (a) the number of times a specific type of labor, childbirth, and the immediate postpartum period. mistreatment occurred per women (potential to record The community survey was piloted separately with a recurring events); or (b) whether a specific type of mis- group of ten women who recently gave birth. Feedback treatment occurred or not (record the first event only). from Nigerian research team on tool implementation in- Ultimately, there was consensus to document recurring formed further revision and finalization of the tools, and events, in order to better understand the magnitude of informed development of the study manual of operations. mistreatment occurring and to have a more complete Piloting the paper tools also helped the research team to documentation of a woman’s childbirth experience. identify design considerations for the digital forms, such as how to structure the digital forms according to the time Validity testing with women who recently gave birth in point when the form would be completed (e.g.: at admis- Nigeria sion, throughout labor, or after childbirth), and whether The phenomenon of interest relates to women’s experi- the form would be completed once (labor observation tool ences during childbirth in health facilities; therefore, we (LOT)-Admission, LOT-Childbirth, community survey considered it important to engage women in the develop- screening and community survey) or multiple times ment of the community survey tool and ensure proposed (LOT-Incident report). items were understandable and considered important to This step resulted in the final draft of the paper-based women. The community survey tool was reviewed by two tools in English. The research team then collaborated to groups of five women from Nigeria (country of the devel- translate the tools into the languages used in the study opment sample) who recently gave birth. This was done contexts. In Nigeria and Ghana, the labor observation in two face-to-face group discussions, facilitated by two tool was in English only, as it was expected that all re- experienced female researchers from the Nigeria team search assistants would speak English, and no verbal (AAO and MO). For each item, women were asked to interaction with research participants was necessary to provide comments on clarity of wording, understandabil- complete the tool. In Guinea, the labor observation tool ity and perceived value of the question. A simple scoring was translated into French. In contrast, the community system was used for the women to rank the level of im- survey tool involved interaction with research partici- portance of the question to themselves and “women like pants, so local language translation was needed. In them” in their communities. Field notes were taken during Nigeria, the tool was translated into Yoruba; in Guinea, the discussion to capture key points, and a short report the tool was translated into French, Malinke, Poular, and was developed to inform the research team. Key revisions Soussou; in Ghana, the tool was translated into Twi; and from this activity centered around ensuring the language in Myanmar, the tool was translated into Burmese. of each question in the community survey was under- standable to women, and a better understanding the im- Step 3: Conversion to digital, tablet-based tools and pilot portance of each item to women. Based on the scoring, all testing (April to august 2016) items were included in the revised version of the tools, as Digital versions of the tools were created using the women considered the questions to be of importance. OpenClinica Participate software (OpenClinica open source software, version 3.1, Waltham, MA, USA). This Tool and item adjustment platform met specific study requirements, including Based on the findings from the content validity testing complex form structure (e.g.: forms with repeating/ with maternal health experts and women in the study multiple or non-repeating/single submission), backend setting, both tools were revised. We eliminated items of processing for data collection and submission in areas low relevance, or merged items that conveyed similar with poor 3G connectivity, offer different language and Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 6 of 15 alphabet requirements (eight languages across four observations were not conducted in Myanmar, as it was study sites), and maximizing ease of use for data collec- not contextually appropriate for nonclinical researchers tors. A low-cost Android tablet, locked for all purposes to be present on the labor wards. other than data collection, was used in all sites. Tablet-based forms were piloted in all four study sites Ethical approvals by all data collectors, during data collection training This study was approved by the World Health workshops. Piloting the forms during the workshops Organization Ethical Review Committee (protocol: allowed the research team to develop and test responses A65880) and the World Health Organization Human to scenarios that may arise during data collection, such as Reproduction Programme (HRP) Review Panel on Re- handover of labor observations between research assis- search Projects. This study was also approved by tants (in case the woman did not give birth by the end of in-country ethical committees in: Guinea [le comité na- the research assistant’s shift), as well as familiarizing the tional d’éthique pour la recherche en santé]; Nigeria research assistants with the research environment. Only [Federal Capital Territory Health Research Ethics Com- minor revisions around local language translations were mittee; Research Ethical Review Committee, Oyo State; made during this step. and State Health Research Ethics Committee of Ondo State]; Ghana [Ethical Review Committee of the Ghana Step 4: Data collection and analysis (September 2016 to Health Service; Ethical and Protocol Review Committee February 2018) of the College of Health Sciences, University of Ghana]; WHO staff and local principal investigators conducted and Myanmar [Ethics Review Committee, Department of dedicated training workshops in each study site for re- Medical Research] (full details in Declarations section). search coordinators, data collectors and other research team members including a midwife from each study site. Results Each study site had a research coordinator who was also Data were collected from September 2016 to February an obstetrician currently practicing at that site. Due to 2017 in Nigeria, and from July 2017 to February 2018 in the sensitive nature of this study, all data collectors were Guinea, Ghana and Myanmar. This section outlines the female. Most data collectors were public health or social structure, administration format and implementation of work graduates, and none had a clinical background the labor observation and community survey tools in (such as nursing, midwifery, medicine) to minimize bias. Ghana, Guinea, Nigeria and Myanmar. For each tool, the Workshops included: (1) an overview of the study and following aspects are described: an overview of study pro- study design; (2) dissemination of results from qualita- cedures and workflow, structure and formatting of forms, tive formative research; (3) review of the study manual and implementation of the tool in the study context. of operations; (4) piloting tablet-based forms; and (5) de- Additional study forms for use during implementation are veloping an implementation plan. described, including the screening logs, data submission As the development sample, the tools were initially im- logs, and data collection discrepancy report. The final plemented in Nigeria (September 2016 to February 2017). section describes linking participant data between the The main revision after this phase was to the structure of labor observations and community surveys. the module related to the care around labor and child- birth. The tool initially had an additional form to complete Labor observation tool (LOT) related to inpatient care (pain relief, labor companionship, Potential study participants for the labor observation com- fluids, mobilization, unreasonable demands, fee structures ponent were consenting women who were giving birth in and neglect). The revised version of the forms imple- study facilities. Pregnant women in established labor (as mented in Ghana and Guinea incorporated this form and per the treating clinician’s assessment) who presented to all questions into the form “Labor observation childbirth, participating facilities during the study period were interventions and discharge,” in order to improve effi- approached to participate. Eligible women who consented ciency of data collection. No changes were made to the to participate were recruited in the study. Women were community survey tool after implementation in Nigeria. then continuously observed from the time of recruitment Data collection for the validation sample (Ghana, (at admission for childbirth), through labor and childbirth, Guinea, Myanmar) was completed from July 2017 to until two hours postpartum or discharge (whichever hap- February 2018. Issues identified during training work- pened first). One research assistant observed only one shops resulted in minor revisions to tablet-based forms woman at a given time. Data collectors were instructed to (e.g.: ensuring local language translations were accurate observe women in a quiet, unobtrusive manner and not to and understandable). These revisions were made to the contribute to the provision of care. Women were observed tablet-based forms, and the tablets were reprogrammed continuously even if they were moved between wards or to activate for use in the study environment. Labor rooms, for example moving from the labor ward to Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 7 of 15 delivery ward (except on the rare occasion that the incident report form; and (3) childbirth, interventions provision of emergency clinical care prevented observa- and discharge form. Figure 3 visually depicts the struc- tion). Figure 2 depicts the study procedure and workflow ture of the labor observation tool. for the labor observations. The tablet-based labor observation tool was used for Labor observation tool admission form data collection, available in full in Additional file 1: The first form completed was the labor observation Labor observation tool. The labor observation tool is tool-admission (LOT-Admission) form. This form was comprised of three forms: (1) admission form; (2) completed immediately after the woman was recruited in Fig. 2 Study procedure and workflow for the labor observations. All images developed by the research team Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 8 of 15 Labor observation tool childbirth, interventions and discharge form This form was completed at the end of the period of ob- servation (one per woman). This form captured informa- tion about what events transpired throughout the woman’s labor and childbirth period, including pain re- lief, mobilization, fluids, labor companionship, demands from healthcare providers, fees, neglect, the childbirth outcome, status of the baby, privacy during childbirth, availability of beds, maternal interventions and informed consent, newborn interventions, referral/discharge, and outcome of observation. Implementation of labor observation tool Overall, 2806 women were screened for the labor observa- tions, and 2019 women (72.0%) were eligible to partici- pate. From this, 2016 women (99.9%) were observed: 408 from Nigeria, 682 from Guinea, and 926 from Ghana. Women who were eligible for participation but were not Fig. 3 Visual depiction of the structure of the labor observation tool observed (3 women, 0.1%) were excluded because they did not provide consent. As reported above, labor observa- the study, and was completed only once for all women. tions were not conducted in Myanmar, as it was not con- This form captures screening questions, and sociodemo- textually appropriate for nonclinical researchers to be graphic information about the woman, such as her age, present on the labor wards. education, marital status, and obstetric history. Labor observation tool incident report form Community survey tool (CST) The second form to complete was the labor observation Potential study participants for the community survey com- tool-incident report (LOT-Incident Report) form. This ponent were women who were giving birth in the study fa- form was completed if, and only if, one of the following cilities and were available for a follow up interview up to events occurred: physical abuse, verbal abuse, stigma eight weeks postpartum. Pregnant women in established and discrimination, or a vaginal examination. If one of labor who presented to participating facilities during the these incidents occurred, then the form was completed study period were approached to participate. Eligible and submitted immediately. This form could have been women who consented to participate were recruited in the completed and submitted multiple times, in case of mul- study, and contact information was obtained to schedule an tiple instances of physical abuse, verbal abuse, stigma interview. Figure 4 depicts the study procedure and work- and discrimination, or vaginal examination (e.g.: repeat- flow for the community survey. ing form to capture more than one event), or never, in During the survey, the tablet-based community sur- case none of these instances occurred. For instances of vey tool was used for data collection, available in full physical or verbal abuse, or stigma and discrimination, in Additional file 2: Community survey tool. The com- this form captured information about the timing of the munity survey tool is comprised of two forms: (1) com- incident (intrapartum or postpartum), the time the inci- munity survey screening form; and (2) community dent occurred (00:00–23:59), and who did it (doctor, survey form. midwife, nurse, trainee, non-clinical staff, family member or companion of the woman, unknown; possible for multiple people to be involved). Community survey screening form For instances of vaginal examinations, this form cap- The first form to complete was the community survey tured information about whether the exchange of infor- screening form. This form was completed to assess the mation, consent, privacy, and confidentiality was observed woman’s eligibility to participate in the study, and was or not. Because multiple vaginal examinations can occur completed only once for all women at admission. If the throughout a woman’s labor, vaginal examinations were woman was eligible and willing to participate, then the reported as “incidents”, so that information could be re- form prompted the data collector to obtain contact in- corded about multiple events. formation to schedule an interview. Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 9 of 15 Fig. 4 Study procedure and workflow for the community survey. All images developed by the research team Community survey form pain relief ), childbirth outcomes, interventions, postpar- The second form to complete was the community sur- tum depression, future childbearing intentions and satis- vey form. Figure 5 visually depicts the structure of the faction with care. community survey form. This form was completed dur- ing the follow-up survey, and was completed once for all Implementation of community survey tool women. This form captured sociodemographic informa- Overall, 3806 women were screened for the community tion, obstetric history, birth experiences (including mis- survey, and 3417 women (89.8%) were eligible to partici- treatment, vaginal examinations, companionship, and pate. Of the eligible participants, a total of 2672 women Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 10 of 15 medical record number, and pre-screening eligibility. The participant number became the unique identifier for each study participant, and was used to anonymize the identity of participants. Data submission log Each data collector tracked the forms that they submit- ted on the tablet using a paper-based data submission log (Additional file 5: Data submission log for the labor observation, Additional file 6: Data submission log for the community survey). This log was shared on a weekly basis with the data management team, to ensure that all forms completed and submitted via the tablet were re- ceived in the central database. This log helped identify any instances where forms were submitted but not re- ceived. This was usually due to a poor 3G connection, where the forms would save locally on the tablet await- ing upload. The data management team would then prompt data collectors to synchronize data using a stronger connection or WiFi. Fig. 5 Visual depiction of the structure of the community survey tool Data collection discrepancy report In case of any errors on forms that had already been submitted, a data collection discrepancy report was sub- (78.2%) completed the community survey: 561 from mitted by the research assistant to identify the error and Nigeria, 644 from Guinea, 836 from Ghana, and 631 suggest a corrected value (Additional file 7: Data collec- from Myanmar. Women who were eligible for participa- tion discrepancy report). Any discrepancies identified tion but did not complete the community survey (745 were submitted to the central data management team, women, 21.8%) were excluded because they did not give and corrections were managed in the central database. consent (100 women, 13.4%), were unable to be reached by phone (404 women, 54.2%), moved or address was Linking participant data in the labor observation and not found (135 women, 18.1%), were referred from the community survey study hospital (9 women, 1.2%), were not contacted be- Some women were eligible for participation in both the cause sample size was reached (94 women, 12.6%), or labor observation and community survey, and participation were screened prior to the start of data collection (3 in one component did not exclude participation from the women, 0.4%). other component. For this group, collecting the unique hospital/medical record number on the screening form and Additional study documents data collection forms allowed for the labor observation and Several other study documents were used to manage the community survey records to be linked. Linked data allows recruitment and data collection process: (1) screening for a comparison of the birth experience from two perspec- log; (2) data submission log; and (3) data collection dis- tives: the woman-reported community survey and the inde- crepancy report. pendent observation of labor. Of the 2016 women who participated in the labor observations across the three Screening log countries, 1536 women (76.2%) also participated in the A screening log was used at each study site to track poten- community survey and have linked data. This includes 779 tial study participants assessed for recruitment in both the women in Ghana (84.1%), 425 women in Guinea (62.3%), labor observation and community survey. Additional file 3: 332 women in Nigeria (81.4%). Screening log for the labor observation shows an example of the screening log for the labor observation, and Add- Discussion itional file 4: Screening log for the community survey Key findings and future analyses shows an example of the screening log for the community The mistreatment of women during childbirth is globally survey. Each woman arriving at the study facility for child- recognized as a serious issue threatening maternal health birth was sequentially assigned a participant number, and and well-being, but there is no consensus on how to best information was recorded about her initials, hospital/ measure this phenomenon to monitor and track progress. Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 11 of 15 This paper presents the development of two tools (labor collectors and data managers. The use of tablets ensured observation and community survey) to measure the mis- that the tools and participant responses were confiden- treatment of women during childbirth. A mixed-methods, tial, which was particularly important for labor observa- iterative approach was used to develop these tools, which tions in clinical environments. Skip patterns and data are now available for use. We encourage other researchers validation checks built into the tablet forms improved to use these tools to measure mistreatment during child- data quality. birth occurring in their contexts, and ultimately to im- However, the OpenClinica software was sometimes prove women’s health and birth experiences globally. cumbersome for the data collectors, as it was not possible Analysis for this study is ongoing across several do- to prompt the questions (e.g.: to view part or all of the mains. First, multi-country epidemiological analyses questions at a glance), which impacted the time spent to are underway to assess women’s and newborn’s experi- complete the forms in cases where new information ences of mistreatment and health and well-being out- emerged. After submitting the forms to the server, data comes, based on both the labor observation and collectors could not retrieve the data, so any revisions or community survey data. Second, psychometric analyses changes had to be processed through the central data are being conducted to validate two scales (labor obser- management unit through submission of data discrepancy vation and community survey) to measure the mis- reports. This process ensured consistency and transpar- treatment of women during childbirth based on the ency to any revisions to the data, but was an additional multi-country data. Once these analyses are completed, burden for the data collectors. Due to the specifics of the we expect to propose two validated scales for measur- incident report form structure, it was sometimes challen- ing the mistreatment of women during childbirth ging for data collectors to capture complex incidents (e.g.: through labor observation and community surveys, and multiple forms of mistreatment happening concurrently have a better understanding of the magnitude and by multiple people). To ensure a reliable and complete re- types of mistreatment that women and newborns ex- port of a complex incident, data collectors wrote down perience during childbirth in Ghana, Guinea, Myanmar the details of the incident and completed the incident re- and Nigeria. port once the situation resolved. Finally, battery life was Researchers and program managers may find it useful variable on the tablets; because unreliable electricity to embed (or adapt) these tools into quality improve- sources in some study settings, data collectors were given ment programs, though further research would be power banks. needed to assess their use in this context. For example, Measuring the mistreatment of women during child- they could explore how the mistreatment survey ques- birth is a complex task. We chose to prioritize the de- tions may be integrated into other quality improvement velopment of direct observations of labor and a measurement tools, such as facility-exit interviews. community-based follow up survey, over facility exit in- Likewise, it may be possible for aspects of the labor terviews with women. Although facility exit interviews observation tool to be integrated into facility-based as- may be logistically more feasible to implement rou- sessments, such as a routine visit to and observation of tinely, women may underreport mistreatment while in the labor ward. a facility setting (reporting and social desirability bias) [24, 27]. In this study, labor observations were con- Limitations and strengths ducted continuously (24 hours a day, seven days a A key strength of this study is that it was conducted in week, with one observer per woman). While resource- twelve health facilities and community catchment areas intensive, childbirth is an unpredictable event that can across four countries, and involved a multi-disciplinary occur at any time of day. Less than 24-hour coverage team of researchers with backgrounds in social sciences, could contribute to selection and truncation bias; for midwifery, obstetrics, and public health. We used a rigorous example, women who arrived at the hospital outside of approach to develop the tools, including a mixed-methods observation times (e.g.: at night) would be excluded systematic review, primary qualitative research, and system- from participating in the study. These women may have atic mapping of existing tools. different characteristics and experiences compared to The research team decided to use tablet-based data women giving birth during the day. Similarly, if a collection for this study, in part to ensure confidentiality woman recruited in the study did not give birth during of responses during the labor observations. Tablet-based the period of observation, then her observation would data collection had strengths and limitations, both from be stopped prematurely, posing a threat of truncation a data collection and data management perspective. Tab- bias (e.g.: incomplete data), as well as an inefficient use lets made data collection faster and more user-friendly. of study resources (e.g.: need to oversample for the The immediate data upload to the central database im- labor observations due to the expectation of incomplete proved efficiencies in communication between data observations). In this study, a structured handover Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 12 of 15 between data collectors was used, in case the period of program implementers to implement these tools in their observation for a woman overlapped more than one contexts when they are interested in measuring the mag- data collector’s shift. Furthermore, the research team nitude of mistreatment during childbirth. It is our ex- sought insight from other researchers who have con- pectation that these tools will continue to evolve as ducted labor observations and debated the most appro- further studies are conducted. By measuring the mis- priate characteristics for data collectors facilitating the treatment of women during childbirth, we will be able to labor observations. Due to concerns that data collectors design and implement programs and policies to trans- with a clinical background (e.g. retired or student form maternity services on a global scale. midwives, nurses or doctors) may have normalized behaviors that could be categorized as mistreatment, Additional files we decided to have data collectors with public health or social work backgrounds. It is possible that this may Additional file 1: Labor observation tool. This file includes the tablet- have impacted their assessments of more clinical based labor observation tool used for data collection. (PDF 282 kb) aspects of the labor observations, such as vaginal Additional file 2: Community survey tool. This file includes the tablet- based community survey tool used for data collection. (PDF 376 kb) examinations. Additional file 3: Screening log for the labor observations. This is an example of the participant screening log used for the labor observation. Research and implementation priorities (DOCX 96 kb) More research is needed to further refine these tools and Additional file 4: Screening log for the community survey. This is an optimize measurement of mistreatment during childbirth example of the participant screening log used for the community survey. (DOCX 83 kb) in facilities, including how to integrate into routine audit Additional file 5: Data submission log for the labor observation. This is and feedback. We acknowledge that direct, one-to-one an example of the data submission log used to record tablet-based form observations of labor and community-based follow up submission for the labor observation. (DOCX 74 kb) may be difficult to implement in routine quality improve- Additional file 6: Data submission log for the community survey. This is ment. However, much can be learned, adapted, and imple- an example of the data submission log used to record tablet-based form submission for the community survey. (DOCX 65 kb) mented from these approaches and tools. For example, Additional file 7: Data collection discrepancy report. This is an example elements of the labor observation tool may be integrated of the data collection discrepancy report used by the data collectors to into routine monitoring visits or service availability and identify and suggest corrected values for any errors on forms that were readiness (SARA) assessments, either at the level of the already submitted. (DOCX 71 kb) facility or at the level of an individual woman. Likewise, specific modules from the community survey tool may Abbreviations be integrated into population-based surveys or other LMIC: Low and middle-income countries; SARA: Service availability andreadiness; WHO: World Health Organization community-based follow up of postpartum women. Scale development and prevalence analyses are cur- Acknowledgements rently ongoing for the labor observations and commu- We would like to express our gratitude to the women and providers who participated in this study. We are sincerely grateful to the dedicated team of nity surveys; as such, further refinements to both tools research coordinators and research assistants in Guinea, Ghana, Nigeria and is expected. Myanmar, without their tireless efforts, this project would not have been possible: Nigeria team: Dr. Adesoji Adeyanju, Dr. Theresa Irinyenikan, Dr. Adeniyi Conclusions Aderoba, Professor Lanre Olutayo, Dr. Musibau Titiloye, Ms. Adenike Adesina, The transformative agenda of the SDGs provides a glo- Mrs. Funmilayo Aminat Adelakun, Ms. Oluwatosin Dorcas Alabi, Ms. bal landscape to address health and gender inequalities, Anuoluwapo Oluwaseyi Adegbite, Mrs. Christiana Y. Abiodun, Ms. Aregbesola Oluwabusayo Hannah, Ms. Tolulope Adekunbi Adeleke, Ms. Oluwatobiloba and improve healthcare experiences. Eliminating all Fatodu, Ms. Mary Chinenyenwa Ginika, Ms. Temitope Olaomoju Ajayi, Ms. forms of the mistreatment of women during childbirth Afolabi Mary Omowumi, Mrs. Akinseye Bunmi R., Ms. Samson Ifeyinwa in facilities is an important component of efforts to Blessing, Mrs. Fasanmi Titilayo Omowumi, Mrs. Bolade Aderonke Funmi, Mrs. Olaleye Olajumoke Victoria, Mrs. Famudehin Jumoke Evelyn, Mrs. Giwa transform maternity services globally to be centered on Olabanke Ganiyah, Ms. Rufai Habibat, Mrs. Oparinde Adame Ada, Ms. Dibio the needs of women and their families. To achieve this, Chioma, Mrs. Adesina Olusola Precious, Ms. Mburiche Juliana, Mrs. Fadahunsi measurement tools are required to understand the mag- Abosede Helen, Mrs. Olotu oluwatosin, Mrs. Aremo Omolola, Mrs. Balogun Mercy, Mrs. Odewusi-Gas Oluwapelumi, Mrs. Ambeke Tomilola, Mrs. Juba Olu- nitude and burden of mistreatment across contexts and waseyi Ayotope, Mrs. Ogunjimi Oluwakemi, Ms. Ayejusunle Esther, Ms. Famo- to reliably measure progress and identify areas where in- juro Taiwo, Ms. Ayilaran Oluwaseun, Dr. Martins Adesina, Dr. Bukola Aloba, Dr. terventions and policies are needed. We used a system- Adebanjo Ogunjinmi, Mrs. Eunice Awoyemi, Mrs. Ifeoma Offiah, Mrs. Olubisi Oduntan. atic, mixed-methods approach to develop two tools Ghana team: Dr. Kofi Ablorh, Dr. Kwame Anim-Boamah, Dr. Frederickson (labor observation and community survey) to measure Pobee, Dr. Ama Tamatey, DDNS Joyce Ofori-Akyea, PNO Susana Asamoah, the mistreatment of women during childbirth in four DDNS Philomena Tamakloe, Humphrey Dickson, Najat Dauda, Angela Asantewa, Muniratu Venu, Rosaline Akangah, Stella Nubuor, Belinda Adjei, Philomina countries, and have made these tools openly available in Agbasi, Zuliehatu Nakobu, Esther Sarpong, Benedicta Atsu, Alberta Addo, Sheila the public domain. We encourage other researchers and Masope, Charity Assem, Dina Agbayizah, Constance Ofori Achiaa, Anita Bohren et al. BMC Medical Research Methodology (2018) 18:132 Page 13 of 15 Odametey, Evelyn Tamma, Esther Puobewere Peng-Yir, Adjoa Nyamaa-Pokua, Ghana Health Service (GHS) (Protocol ID GHS-ERC-13/01/15)]; and Myanmar Lady Fatimah Daniels, Justine Coomson, Pearl Akoto-Bamfo, Adoma Osei Pipim, [Ethics Review Committee, Department of Medical Research (protocol ID Pearl Aovare, Nafisatu Sulemana, Mariam Josiah, Caroline Badzi, Harriet Agyei, (Ethics/DMR/2017/096)]. All participants provided written informed consent Sylvia Asiamah, Claribel Asher, Juliet Anador, Debora Obeng Agyei. prior to participation. Myanmar team: Dr. Kyaw Zin Thant, Dr. Yin Yin Soe, Dr. Hla MyaThway Einda, Dr. Khaing Nwe Tin, Dr. Wai Wai Han, Dr. Lei Yee Win Maw, Dr. Aye Consent for publication Kyawt Paing, Dr. Swe Mon Oo, Dr. Kyaw Lwin Show, Dr. Nyein Su Aye, Dr. Not applicable. Phyo Aung Naing, Dr. Nyi Nyi Zayar, Dr. San San Myint Dr. Khin May Thin, Dr. Khin Sanda Kyaw. Competing interests Guinea team: Aissatou Diallo, Sadan Camara, Poret Sangare, Ramata Diallo, The authors declare that they have no competing interests. Oumar Sall, Saloum Cherif, Siba Theodore Koropogui, A.Karim Bah, Bernadette Dramou, Kadiatou Adama Diallo, Oury Bella Diallo, Djenabou Sow, Téwa Bintou Kamano, Maimouna Sangaré, Suzanne Beavogui, Nana Publisher’s Note Ibrahima Camara, N’dèye M’bogna Mbengue, Fatou Bakayoko, Mariama Springer Nature remains neutral with regard to jurisdictional claims in Souare, Porèt Sangare, Dimeye Thea, Rachelle Kamano, Cécile Kamano, Fanta published maps and institutional affiliations. Barry, Tady Camara, Sira Diakite, Coumbel Conde, Madeleine Toure, Marie Siazia Onivogui, Jeannette Nowai Gbilimou, Marie Guilavogui, Marie Author details1 Madeleine Bendja, Gnama Koïvogui. UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, We would also like to thank the following individuals for sharing tools from Development and Research Training in Human Reproduction, Department of their studies, which were sometimes ongoing at the time of mapping Reproductive Health and Research, World Health Organization, 1211 Geneva, exercise. We greatly appreciate their spirit of scientific collaboration and Switzerland. 2Gender and Women’s Health Unit, Centre for Health Equity, transparency: Charlotte Warren, Charity Ndigwa, Timothy Abuya, Kate Melbourne School of Population and Global Health, The University of3 Ramsey. We would also like to thank the following individuals for their Melbourne, Carlton, VIC 3053, Australia. Department of Obstetrics and invaluable guidance throughout the project: Mary Ellen Stanton, Deborah Gynecology, National Institute of Maternal and Child Health, College of Armbruster, Neal Brandes, Olufemi T. Oladapo, Soe Soe Thwin. Medicine, University of Ibadan, Ibadan, Nigeria. 4School of Public Health, 5 This article represents the views of the named authors only, and not the University of Ghana, Accra, Ghana. Department of Medical Research,6 views of their institutions or organizations. Yangon, Myanmar. Cellule de Recherche en Santé de la Reproduction en Guinée (CERREGUI), University National Hospital-Donka, Conakry, Guinea. 7 Funding Faculté de Médecine, Pharmacie et Odontostomatologie, Université G.A. Nasser de Conakry, Conakry, Guinea. 8Department of Health Promotion and The funders had no role in the study design, data collection and analysis, Education, Faculty of Public Health, College of Medicine, University of Ibadan, decision to publish, or preparation of the manuscript. Funding for this project Ibadan, Nigeria. 9Department of Obstetrics and Gynecology, School of was received from the United States Agency for International Development Medicine and Dentistry, University of Ghana, Accra, Ghana. 10Département (USAID). Funding for project activities in Guinea was received from a long-term de sociologie, Université Sonfonia, Conakry, Guinea. institutional development (LID) grant to Cellule du recherche en la sante de la reproduction (CERREGUI) from the UNDP/UNFPA/UNICEF/WHO/World Bank Received: 17 May 2018 Accepted: 1 November 2018 Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization. References 1. World Health Organization. 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