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Article

Co-Development and Content Validity of an Instrument to Collect Integratively the Social Determinants of Health in Postpartum Lactating People

by
Paula Eugenia Barral
1,
Agustín Ramiro Miranda
2 and
Elio Andrés Soria
1,3,*
1
Consejo Nacional de Investigaciones Científicas y Técnicas, Instituto de Investigaciones en Ciencias de la Salud (INICSA), Bv. de la Reforma, Ciudad Universitaria, Córdoba 5000, Argentina
2
MoISA, University Montpellier, CIRAD, CIHEAM-IAMM, INRAE, Institut Agro, IRD, 911 Avenue d’Agropolis, Cedex 5, 34394 Montpellier, France
3
Cátedra de Biología Celular, Histología y Embriología, Instituto de Biología Celular, Facultad de Ciencias Médicas, Universidad Nacional de Córdoba, Bv. de la Reforma, Ciudad Universitaria, Córdoba 5000, Argentina
*
Author to whom correspondence should be addressed.
World 2025, 6(3), 120; https://doi.org/10.3390/world6030120
Submission received: 11 June 2025 / Revised: 15 August 2025 / Accepted: 22 August 2025 / Published: 1 September 2025
Browse Figure
Review Reports Versions Notes

Abstract

Postpartum lactating people are particularly vulnerable to inequities in social determinants of health (SDH), yet no validated tool currently exists to assess these factors comprehensively. This study aimed to co-develop and establish the content validity of an instrument to integratively evaluate SDH in this population. Guided by the Mixed Methods Appraisal Tool, an interdisciplinary e-Delphi panel assessed item sufficiency, clarity, coherence, and relevance. Statistical analyses included the item-level (I-CVI) and scale-level (S-CVI/Ave) content validity indices, average agreement between experts (AABE), Fleiss’ kappa (κ), and Aiken’s V coefficient (V) (p < 0.05). Cognitive interviews were conducted with postpartum lactating participants representing diverse characteristics to assess interpretability. The initial version of the instrument included 135 items across nine sections addressing general demographics, education, employment, home environment, lifestyle, social support, healthcare access, stress, intimate partner violence, insomnia, and nutrition. Based on expert input, it was refined to 131 items through structural and lexical revisions. Content validity indices indicated strong agreement: I-CVI ranged from 0.66–1.00, S-CVI/Ave > 0.95, AABE > 14.26, and κ and V > 0.90. Final adjustments following cognitive interviews led to a 128-item version optimized for clarity and relevance. This instrument offers strong content validity for SDH assessment in postpartum lactating people and supports sustainable use in health research.

Graphical Abstract

1. Introduction

The World Health Organization (WHO) defines social determinants of health (SDH) as the conditions in which individuals are born, grow, live, work, and age—shaped by the distribution of power, resources, and opportunities across communities and institutions. These determinants encompass a wide range of factors, including income, education, labor market dynamics, gender, political structures, cultural norms, psychosocial environments, biological aspects, and the healthcare system. Interacting through complex causal pathways, these elements collectively contribute to health inequities, often clustering among populations with limited access to resources. Addressing the multifaceted nature of SDH poses significant methodological challenges in epidemiology and biostatistics, requiring the integration of multivariate and mixed-methods approaches [1]. Consequently, effective management and analysis of SDH data are essential for evidence-based decision-making and for advancing progress toward the Sustainable Development Goals by 2030 [2].
Health inequalities stem from a variety of structural and social factors, with gender-related issues disproportionately affecting women and LGBTQ+ minorities [3]. These disparities are often reflected in adverse SDH, such as unpaid care and domestic work, precarious employment, unequal power relations, societal expectations, and gender-based violence [4]. Moreover, women’s specific health needs are frequently overlooked, as healthcare systems continue to rely on evidence largely derived from male physiological models (sex-gender bias) or focus narrowly on postpartum reproductive roles [5]. This population represents a particularly vulnerable group, facing elevated risks of postpartum depression, insomnia, and psychological stress [6]. During this period, both internal and external factors can significantly compromise the birthing person’s well-being and hinder practices such as exclusive breastfeeding [7]. In response, there is growing recognition of the need for a comprehensive and integrative approach to reproductive health—one that acknowledges its broader implications not only for parental and infant outcomes, but also for national economic stability and environmental sustainability [8,9]. From Breilh’s critical epidemiological perspective, this pivotal life stage—deeply shaped by SDH—demands the development of innovative, integrative tools and multivariate methodologies to inform more effective and equitable public health interventions [10].
Digital technologies are promising to overcome the challenges involving the plurality and interaction of the SDH during postpartum [11]. In light of the pressing need to redesign and modernize health services through a gender-sensitive approach, this study aimed to co-develop, alongside interdisciplinary health professionals, researchers, and postpartum individuals, a content-valid instrument for the collection of SDH data among lactating people in Argentina. In this context, content validity refers to the degree to which the instrument accurately and comprehensively captures the range of SDH relevant to this specific population [12].

2. Materials and Methods

Qualitative and quantitative methodologies supported the content validation of this instrument, encompassing three distinct phases: a pre-design informed by scientific literature, an e-Delphi method involving expert consensus, and cognitive interviews conducted with the target population [13]. All procedures were rigorously implemented between 2021 and 2023, adhering to the Mixed Methods Appraisal Tool [14], the Declaration of Helsinki, and relevant current laws, and were duly approved by the corresponding Research Ethics Committee.

2.1. Phase 1 (Pre-Design)

To achieve Technology Readiness Level 2 (i.e., experimental research on functionality) [15], a focused research team conducted an extensive state-of-the-art literature review on SDH. Relevant publications were identified through PubMed/MEDLINE, Google Scholar, and SCOPUS, including peer-reviewed articles, guidelines, and books published in Spanish or English since 1990. The conceptual framework proposed by Peña Tocto [16] was used as a foundation to organize core dimensions—namely home environment, lifestyle, access to healthcare, and social security. To assess these domains, the instrument incorporated previously validated questionnaires. The Medical Outcomes Study Social Support Survey (MOS-SSS) [17] and the short Spanish version of the Woman Abuse Screening Tool (WAST-SF) [18] were included; both are freely licensed and do not require formal permission for use. The required licenses for the short versions of the Perceived Stress Scale (PSS-4) [19] and the Insomnia Severity Index (ISI-3) [20] were granted by Mapi Research Trust. The Minimum Dietary Diversity for Women (MDDW) instrument was used following its original license: Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO (CC BY-NC-SA 3.0 IGO) [21].
Furthermore, the review of existing data sources related to these dimensions enabled the development of additional items. Variables such as personal and newborn information, anthropometric data, reproductive history, breastfeeding practices, partnership status, educational level, gender identity and sexual orientation, and current medical issues were incorporated based on previous studies [22,23,24]. Further items addressing topics such as sex education, monthly income, housing conditions and access to green spaces, dietary intake of sweeteners, salt, and infusions, childhood nutritional self-perception, and employment conditions were developed by the authors. Work-related factors (e.g., occupational risks, duration, and satisfaction) were adapted from existing instruments [25]. To assess toxic habits, hygienic measures, number of cohabitants, adherence to gynecological check-ups, and healthcare complexity and coverage, the authors adapted previously proposed tools [16,26,27]. Physical activity levels were measured using the short form of the International Physical Activity Questionnaire (IPAQ-SF), which is available under a Creative Commons license CC BY 4.0 [28].
Following the integration of these sources, the pre-design of the instrument was refined using the ZOPP method. This process was guided by expert consultation and a preliminary pilot test that evaluated comprehension, coherence, readability, formatting, instructions, and response options [29].

2.2. Phase 2 (e-Delphi Method)

Employing an exploratory design, the content validation of the pre-designed instrument commenced with a fifteen-member online e-Delphi panel, utilized as a consensus-building technique. The panel size was determined based on the study’s scope, expert availability, and established recommendations [30]. The experts represented diverse multi- and interdisciplinary fields [31], including instrumental methodology, reproductive health, socio-environmental health, analytical epidemiology, social communication, women’s health, health education, community psychology, gender studies, health sociology, physical education, postpartum nutrition, gynecology and obstetrics, health ecology, and endocrinology. These experts were strategically divided into three distinct groups for consecutive rounds and were presented with open-ended questions in a free and confidential manner regarding the proposed items. Following each round, necessary revisions were implemented before the instrument was submitted to the subsequent group.
Finally, the entire panel received the revised instrument along with a qualification matrix. A four-point Likert scale was employed for assessing item sufficiency, clarity, coherence, and relevance, with the options: excellent, good, fair, and poor. Subsequently, the following statistical indicators were calculated: item-level content validity index (I-CVI), scale-level content validity index based on the average method (S-CVI/Ave), the average agreement between experts (AABE) [32], Fleiss’ kappa coefficient (κ) using STATA 15 [33], and Aiken’s V coefficient (V) per item and criterion, with statistical significance set at p < 0.05 [34].

2.3. Phase 3 (Cognitive Interviews)

To mitigate selection bias, the inclusion criterion was being a lactating adult resident of the province of Córdoba, Argentina, within the first postpartum year. Exclusion criteria comprised pregnancy and the presence of current acute or decompensated chronic pathology, as defined by ICD-11. Intentional recruitment of the target population was conducted through online media (e.g., WhatsApp, Instagram, and Facebook) and the Maternal Hospital of Córdoba [12]. Representation was ensured based on parity (primiparous and multiparous) and educational level (incomplete mandatory formal education, complete mandatory formal education, and initiated higher education), as these factors could influence cognitive and metacognitive strategies for interpreting the instrument. Consequently, six postpartum lactating individuals provided informed consent to participate in think-aloud protocols during instrument completion, guided by instructions and various probes [12,35]. Individual interviews lasted approximately 40 min, and the recordings were subsequently transcribed for analysis. Although these participants were not involved in the design, recruitment, conduction, or dissemination phases of this study, their feedback was sought regarding the instrument’s quality, perceived burden, and time commitment required for participation.

3. Results

3.1. Phase 1

The literature review yielded a preliminary set of 135 items, organized into nine sections: general data, educational and work situation, home environment, lifestyle factors, social network, access to health services, self-perceived stress levels, insomnia symptoms, and dietary habits. The majority of items were structured, with a subset requiring brief, restricted-format responses.
The initial “General Data” section collected information on the participant’s date of birth, most recent delivery date, self-reported sex-gender identity and orientation, age (in years), body weight (current and recalled weight between ages 18 and 21, in kilograms), height (in meters), and relationship status (cohabiting, not cohabiting, or without a partner). Subsequent questions explored the number of pregnancies and miscarriages, the type of last delivery, the number of newborns, current breastfeeding practices (exclusive, predominantly human milk mixed feeding, predominantly formula mixed feeding, or combined feeding with other foods), and the number of individuals under their care, including the reasons for this responsibility. Finally, the health issues and treatments of both the participants and their families were inquired about.
The second section focused on the highest educational level attained by the participant and cohabiting household members, as well as the participant’s experience with sex education—including its source, perceived adequacy, and integration into formal education program—and overall family income. Occupation was classified according to federal labor laws, encompassing unpaid domestic work. Additionally, the section includes information on environmental risks at the workplace (biological, chemical, physical, and psychological), working hours, and job satisfaction level (using a five-point Likert scale). Finally, the section incorporated items asking participants to indicate whether they received any form of governmental economic assistance (none, pension, retirement benefits, unemployment funds, family support, or scholarship).
The third section explored the participant’s home setting (urban, peri-urban, or rural), city, neighborhood, and proximity (within a one-kilometer radius) to various environmental and social resources or hazards: green/recreational areas, food sources, waste disposal sites, agricultural and livestock areas, industrial/factory zones, educational institutions, public transportation access points, community/economic networks, and an open “other” or “none” option. Furthermore, a five-point Likert scale assessed self-perceived insecurity within their neighborhood. Regarding housing characteristics, ownership was categorized as property, rental, community housing, or other; construction materials for floors, walls, and ceilings were recorded as durable (e.g., concrete, brick, stone) or other. The section also gathered data on the number of cohabitants and rooms in the house, access to domestic service, the availability of essential public services (drinking water, piped gas, sewage system, electricity, and waste disposal), and the presence of outdoor spaces associated with the dwelling.
The fourth section, focusing on lifestyle, assessed alcohol consumption (frequency per month and week and quantity), smoking habits (number of cigarettes per week), and the use of psychotropic substances (cocaine, marijuana, ecstasy, related compounds, anxiolytic drugs, other substances, or none). This section also covers daily access to hygienic measures and the practice of regular medical checkups. Regarding cervical and breast cancer screenings, the date and result (normal or abnormal) of their last examination are inspected. Questions also covered breast examination by a professional and self-examination (whether they had been informed or trained by a professional and the frequency of self-practice), and any history of sexually transmitted infections. Finally, physical activity levels were assessed according to international standards, recording the weekly frequency and duration (in minutes) of intense, moderate, and walking activities, as well as daily sitting time (in hours).
The fifth section comprised the MOS-SSS, validated for use in Argentina, and the short Spanish version of the WAST-SF. Access to healthcare (sixth section) was evaluated by recording the highest level of healthcare available in the participant’s city/town (tertiary, secondary, primary, none, or unknown), their healthcare coverage (public or/and private), and their satisfaction levels (using a five-point Likert scale) regarding the distance to obtain care, waiting times, and the overall quality of care received. The seventh and eighth sections utilized the short versions of the PSS-4 and ISI-3, respectively, to assess self-perceived stress and insomnia severity.
The final section focused on dietary habits, utilizing the MDDW questionnaire. It also explored the use of salt (for cooking, at the table, alternative spices used, and weekly frequency of consuming salty foods), sweeteners (types used in foods and beverages, the primary sweetener, alternative sweeteners used, and weekly frequency of consuming sweet foods and beverages), and the consumption of coffee and tea (weekly and daily frequency, with cup size specified), as well as yerba mate (weekly and daily frequency, in milliliters), employing visual aids to standardize serving size estimation. Lastly, an item was included asking participants to rate their level of satisfaction and perceived adequacy of their childhood diet on a ten-point Likert scale.

3.2. Phase 2

The experts’ assessments were duly received and integrated into the instrument. This process led to several refinements, including grammatical improvements, clarifications (e.g., specifying types of breastfeeding practices and providing examples of hygienic measures), lexical adaptations (e.g., replacing “people under control” with “people under care” and “natural” with “vaginal” delivery), and structural modifications. The primary changes implemented were:
  • Format adaptation: Adjustments were made to charts and Likert scales for improved clarity and ease of use.
  • Item removals: Items concerning family medical history, the highest educational level of other household cohabitants, and access to domestic services were removed.
  • Reorganization of response options: Response options for medical issues were reorganized based on their prevalence in the target population.
  • Merging of items: Separate items assessing the adequacy and satisfaction with one’s diet during childhood were combined into a single item.
Following the incorporation of feedback and revisions, the quality of the resulting 131-item instrument was supported by I-CVI scores ranging from 0.73 to 1.00, with the exception of the clarity of one ISI-3 item (concerning current sleep problems), which scored 0.66. The values presented in Table 1 robustly confirmed the instrument’s content validity, with a S-CVI/Ave and an AABE exceeding 0.95 and 14.26, respectively, across all criteria. Furthermore, κ coefficients were statistically significant, and V coefficients per criterion consistently exceeded 0.90, with narrow 95% confidence intervals.

3.3. Phase 3

Modifications were implemented based on the participants’ comments, questions, and responses during the cognitive interviews; specific examples are detailed in Table 2. In the first section, participants with lower educational attainment reported difficulty understanding the term “sexual orientation”, leading to a clarification of the response options. Two items concerning individuals under the participant’s care were merged due to ambiguity in defining the dimensions being assessed, which can limit their analytical value. Regarding questions about medical treatments, the inclusion of frequent examples (e.g., contraceptive drugs, nutritional supplements, and “none”) improved comprehension among primiparous participants with varying educational levels. Descriptions of location areas in the third section were clarified to enhance understanding for participants with lower educational attainment. Questions in the fourth section were refined to specifically address current consumption patterns and toxic habits. Furthermore, questions about mammography and breast self-examination were made more explicit. Notably, the average time to complete the instrument was under 40 min, and all postpartum participants completed it satisfactorily in a single session without interruptions.
Additional improvements were made following a comprehensive analysis of the cognitive interview data, resulting in the following item changes:
  • The question “¿Cuál fue su peso aproximado en kilogramos entre los 18 y 21 años? Inserte un número.” [English: “What was your approximate weight in kilograms between the ages of 18 and 21? Please insert a number.”] was eliminated.
  • The question “¿Recibió ESI (educación sexual integral)?” [English: “Did you receive CSE (Comprehensive Sex Education)?” was eliminated.
  • In the question “¿Cuál es su ocupación?” [English: “What is your occupation?”], the term “ocupación” [English: “occupation”] was replaced with “trabajo pago” [English: “paid job”] to define the item more precisely excluding caregiving activities.
  • The question “¿Dónde vive? Escriba localidad y barrio” [English: “Where do you live? Enter your town and neighborhood”] was split into two open-ended questions: “¿Cuál es su localidad?” [English: “What is your town?”] and “¿Cuál es su barrio?” [English: “What is your neighborhood?”].
  • The question “En 10 cuadras a la redonda desde su hogar, ¿tiene alguna de las siguientes locaciones? Puede marcar más de una casilla” [English: “Are any of the following locations within 10 blocks of your home? You can select more than one”] was revised to include examples.
  • WAST-SF: The option “No tengo pareja” [English: “I do not have a partner”] was added.
  • The questions “¿Endulza los alimentos y las bebidas?” [English: “Do you add sweeteners to your food or drinks?”] and “¿Con qué endulza sus comidas y bebidas? Puede marcar más de una casilla” [English: “Which sweeteners do you use for your food and drinks? You can select more than one”] were merged into a single item: “¿Con qué endulza principalmente sus comidas y bebidas?” [English: “Which sweeteners do you mainly use for your food and drinks?”]. The answer option “No endulzo mis comidas y bebidas” [English: “I do not sweeten my food and drinks”] was added.
  • The expressions “alto contenido de azúcar” [English: “high in sugar”] and “alto contenido de sal” [English: “high in salt”] were replaced by the terms “azucaradas” [English: “sugary”] and “salados” [English: “salty”], respectively, to reduce social desirability bias.

4. Discussion

This study aimed to co-develop a content-valid instrument for collecting SDH data among lactating people, in collaboration with interdisciplinary health professionals, researchers, and postpartum individuals. To the best of our knowledge, it is the first instrument specifically validated for assessing SDH in this population. The final instrument comprises 128 items across nine sections, intended for remote self-administration. This approach offers an affordable and efficient means of gathering extensive data promptly. The expert panel and the target population sample effectively represented professionals engaged in SDH and patients with diverse profiles, respectively [3,36]. The robust content validity of the instrument was empirically supported by the achievement of optimal quality indicators [31,32,33,34]. Furthermore, the cognitive interviews provided valuable insights into strategies for enhancing the instrument’s interpretability by the target population [35].
In the first section, the inclusion of dates of birth and last delivery served to establish the participants’ age and postpartum status, respectively, both recognized as significant biological factors influencing health and breastfeeding outcomes [37]. The assessment of sex-gender identity and orientation were included to broaden the instrument’s applicability to LGBTQ+ individuals [23]. Current weight and height were collected to calculate the body mass index [22], while recalling previous anthropometric data proved unfeasible for all participants (specifically adults younger than 21 years old). Relationship status was assessed due to its established association with various health outcomes [38]. Subsequently, information regarding the number of pregnancies and miscarriages (to determine parity), delivery type, the number of newborns in the most recent delivery, and current breastfeeding practices was gathered, as these items encompass variables with a substantial impact on reproductive health [36]. Furthermore, recognizing that lactating individuals may also be caregivers during the postpartum period, which can have implications for their health and socioeconomic status, this circumstance was considered [39]. This item underwent modification in phases 2 and 3 to refine its scope and enhance clarity [31]. The removal of family medical history was based on its deemed limited relevance to the study’s objectives [31]. Finally, the collection of personal medical history was reorganized following a digital model proposed by the national government (National Law No. 27706) [40].
The second section addressed educational level and sex education, recognizing their established influence on health outcomes [41]. However, the question regarding formal sex education (CSE) was subsequently removed, as a significant portion of the target population had not been subject to the National Law No. 26150 [42] of 2006 during their mandatory schooling. Additionally, experts recommended the removal of an item concerning the highest educational level of a cohabitant due to its limited relevance to the study [31]. The term “occupation” was revised to “paid job” following phase 3 to enhance clarity and avoid ambiguity [12]. Consequently, the response option “unpaid domestic work” was also removed to align with this clarification. Furthermore, the classification of occupation types adhered to the criteria established by the Federal Administration of Public Incomes [43], while the categorization of socioeconomic aid followed national guidelines [44].
The geographic space where people reside significantly influences various risks and protective factors for health, as addressed in the third section [45]. The initial item concerning neighborhood and city was separated into two distinct questions to prevent data loss and enhance specificity (phase 3) [12]. Furthermore, the detailed categorization of food sources is crucial for understanding access in the context of food sovereignty and security [46]. Regarding home conditions, assessing access to a sewer system and the materials used in housing construction provides insights into sanitation facilities [47]. While the distribution of domestic tasks is an important aspect of social determinants [4], the question about domestic help was eliminated due to its limited relevance to the study’s primary focus (phase 2) [31]. In the fourth section, items about gynecological check-ups employed a structured algorithm for responses [12]. The inclusion of WAST-SF items in the fifth section ensured the collection of relevant and population-specific information regarding intimate partner violence [18]. Experts recommended clarifications to the items concerning access to health in the sixth section [31]. Moreover, the PSS-4 was implemented following the methodology of Miranda et al. (2020) [48] in the seventh section. Similarly, insomnia, assessed using the ISI-3 in the eighth section, is a known indicator responsive to SDH [49]. In this context, the item regarding concern about the current sleep problem was retained despite its lower I-CVI value during phase 2, based on the established validity of the ISI as a whole.
The final section focused on dietary habits, acknowledging their significant impact on health and well-being [22]. It was primarily based on the MDDW, a well-established dietary indicator specifically relevant for this population [21]. The merging of questions regarding sweetener use optimized participant time while still gathering the necessary information with fewer items [12]. Given the regional context, the consumption of coffee, tea, and yerba mate was also assessed [22,50]. Lastly, the questions concerning the self-definition of diet during childhood (adequacy and satisfaction) were combined to improve efficiency and scope, as the comprehensive nutritional assessment involves subjective perceptions that warrant further, more in-depth analysis [51].
The cognitive adequacy of the instrument was supported by feedback from lactating individuals with diverse reproductive histories and educational backgrounds. This process necessitated specific modifications to enhance interpretability, particularly for primiparous individuals or those with lower levels of education, thereby increasing the instrument’s cognitive accessibility [12,36]. Despite its methodological rigor, this study has potential limitations. First, the validation process focused exclusively on content validity. Additional psychometric properties, such as internal reliability, construct validity, and structural validity, should be addressed. Moreover, future research on longitudinal validation and reliability testing is needed to ensure the instrument’s stability and predictive power over time. Second, the instrument was developed in the Province of Córdoba, which may limit its applicability in other sociocultural contexts without prior cultural and linguistic adaptation—an important direction for future studies. Although the co-development process engaged health professionals, researchers, and postpartum lactating people from diverse backgrounds, the limited involvement of other key stakeholders (e.g., policy-makers) may affect the scalability. Although the multidisciplinary composition of the e-Delphi panel enriched the instrument evaluation, it may also have introduced discipline-specific emphases. For instance, physicians may prioritize symptom-oriented items, whereas those from social sciences may emphasize contextual and structural determinants. Similarly, professionals with experience in gender studies and community health may focus on issues of equity, cultural sensitivity, and inclusivity. The e-Delphi structure, anonymity, and iterative feedback rounds balance these perspectives and reduce dominance effects [52,53]. Additionally, the length of the instrument may pose a response burden in time-constrained settings, a concern also raised by the e-Delphi panel. For this reason, we deliberately used reduced versions of all validated instruments. Fortunately, during the cognitive interviews, participants did not report any issues with the length. Despite being offered the option to take a break on multiple occasions, all participants chose to complete the instrument in a single session. They were informed beforehand of the estimated completion time and, upon finishing, they expressed satisfaction and contentment with the research conducted. The authors believe that the logical order of the items and the modular structure of the instrument may have contributed to a smoother completion process. The instrument’s comprehensive design seeks to capture the multidimensional nature of the SDH, prioritizing contextual relevance over brevity. Notwithstanding these limitations, the study’s strengths include a co-development process, a rigorous mixed-methods design as recommended in current literature [54], and inclusion of dimensions expected to inform future research and guide the design of effective and equity-focused health policies aimed at improving postpartum health outcomes [55].

5. Conclusions

This study successfully co-developed and validated a cost-effective instrument with strong content validity to integratively and efficiently assess the complex SDH among postpartum lactating individuals—an area of critical importance that remains underexplored. The tool offers valuable potential for both health research and environmental assessments by providing an integrated understanding of the multifaceted factors affecting this vulnerable population. The findings generated through its application can inform more precise and effective public health policies aimed at reducing health disparities and enhancing postpartum and infant well-being. Furthermore, this work lays the foundation for future validation studies in diverse contexts, ultimately supporting the advancement of more equitable healthcare systems.

Author Contributions

P.E.B.: conceptualization: methodology, software, validation, formal analysis, investigation, data curation, writing—original draft, writing—review and editing, and visualization. A.R.M.: conceptualization: methodology, validation, formal analysis, investigation, writing—review and editing, and supervision. E.A.S.: conceptualization, validation, investigation, resources, writing—original draft, writing—review and editing, supervision, project administration, and founding acquisition. All authors have read and agreed to the published version of the manuscript.

Funding

This research was funded by Secretaría de Ciencia y Tecnología, Universidad Nacional de Córdoba [SECYT-UNC], grant number RESOL-2023-258-E-UNC-SECYT#ACTIP. Paula E. Barral’s fellowship was provided by Consejo Nacional de Investigaciones Científicas y Técnicas, Argentina.

Institutional Review Board Statement

The study was conducted following the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of National Clinics Hospital, National University of Córdoba (registration 017-21042022) on 21 April 2022.

Informed Consent Statement

Informed consent for participation was obtained from all subjects involved in the study.

Data Availability Statement

The data presented in this study are available on request from the corresponding author. The data are not publicly available due to ethical considerations related to the small number of participants and the sensitive nature of the information collected. Given the risk of indirect identification, data sharing is restricted to protect participant confidentiality in accordance with institutional ethical guidelines.

Acknowledgments

The authors acknowledge Mariela V. Cortez and Ana V. Scotta for their advice in nutritional assessment, health professionals of the e-Delphi panel, and postpartum participants.

Conflicts of Interest

The authors declare no conflicts of interest.

Abbreviations

The following abbreviations are used in this manuscript:
AABEAverage agreement between experts
I-CVIItem-level content validity index
IPAQ-SFInternational Physical Activity Questionnaire-Short Form
ISI-3Insomnia Severity Index Three-item Version
MDDWMinimum Dietary Diversity for Women
MOS-SSSMedical Outcomes Study Social Support Survey
PSS-4Perceived Stress Scale Four-item Version
S-CVI/AveScale-level content validity index based on the average method
SDHSocial determinants of health
VAiken V coefficient
WAST-SFWoman Abuse Screening Tool-Short Form
κFleiss’ kappa coefficient

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Table 1. Content validity of the instrument “Social Determinants of Health for Lactating Postpartum People”.
Table 1. Content validity of the instrument “Social Determinants of Health for Lactating Postpartum People”.
SufficiencyClarityCoherenceRelevance
S-CVI/Ave0.970.950.960.96
AABE14.5414.2614.4514.45
κ coefficient0.39 (p = 0.001)0.22 (p = 0.041)0.43 (p = 0.001)0.43 (p = 0.007)
V coefficient0.93 (CI 95% = 0.82 to 0.98)0.90 (CI 95% = 0.78 to 0.96)0.92 (CI 95% = 0.80 to 0.97)0.93 (CI 95% = 0.82 to 0.98)
Note. S-CVI/Ave = scale-level content validity index based on the average method; AABE = average agreement between experts; CI = confidence interval; κ Coefficient = Fleiss kappa coefficient; V Coefficient = Aiken’s V coefficient.
Table 2. Revisions to survey instrument based on cognitive interview findings.
Table 2. Revisions to survey instrument based on cognitive interview findings.
Original ItemDifficulties in ComprehensionReformulation
Question: “¿Cuál es su orientación sexual?”/“What is your sexual orientation?”
Answers: “Heterosexual”, “Homosexual”, “Bisexual”, “Pansexual”, “Asexual”, “Prefiero no decirlo”/“Straight”, “Homosexual”, “Bisexual”, “Pansexual”, “Asexual”, “I prefer not to say”.		Participants expressed confusion regarding the terminology used for sexual orientation, as evidenced by comments such as “No entiendo cuál” (“I don’t understand which one”) and “¿Cómo sería? Los hombres?” (“What would it be? Men?”), indicating a lack of familiarity with abstract labels.Answers revised to include definitions:
“Heterosexual (atracción por personas del sexo opuesto)”, “Homosexual (atracción por personas del mismo sexo)”/“Straight (attraction to people of the opposite sex)”, “Homosexual (same-sex attraction)”.
Questions: “¿Cuántas personas tiene a su cuidado? Inserte un número.”/“How many people are in your care? Enter a number”.
And “¿Cuáles son los motivos de dicho cuidado?”/“What are the reasons for this care?”
Answers: “Menores de edad”, “Personas con discapacidad”, “Adultos/as mayores”/“Minors”, “People with disabilities”, “Older adults”		Respondents were sometimes unsure who to include in their answers (e.g., “¿Va marido también acá o solamente chicos?”—“Does my husband go here too, or only children?”). Some participants found the instructions ambiguous or difficult to interpret.Items merged and reworded for clarity:
“¿Usted tiene personas cercanas bajo su cuidado además de su bebé? Puede marcar más de una casilla.”/“Do you have close people in your care other than your baby? You can select more than one option.”
The answer “No” was added.
Question: “En caso de tomar medicación regularmente, menciónela”/“If you take regular medication, mention it.”Participants asked whether contraceptives should be included or whether the field should be left blank if they took no medication: “¿Acá van las pastillas anticonceptivas?”, "¿Acá no pongo nada? Porque no tomo.”/“Do contraceptive pills go here?”, "Don’t I put anything here? Because I don’t take any medication.” This indicated a need for clearer instructions.Clarified instructions added:
“En caso de tomar medicación regularmente, menciónela (incluidos anticonceptivos y suplementos nutricionales). Si no toma medicación indicar: ‘No’”/“Please specify any medication you take regularly (including contraceptives and nutritional supplements). If you do not take any, please write ‘No’.”.
Question: “¿En qué ámbito vive?”/“What type of area do you live in?”
Answers: “Rural”, “Periurbano”, “Urbano”/“rural”, “periurban”, “urban”		Some participants did not understand the distinction among geographic terms, e.g., “¿Cómo sería?” (“What would that be like?”).Definitions added for clarity:
“Rural (campo)”, “Urbano (ciudad)”, “Periurbano (en las afueras de la ciudad)”/“Rural (countryside)”, “Urban (city)”, “Periurban (on the outskirts of the city)”
Question: “¿Con qué frecuencia consume alguna bebida alcohólica?”/“How often do you consume any alcoholic beverage?”Feedbacks such as “¿Actualmente?” (“Currently?”) and “Y ahora pongo ‘nunca’, por lo del bebé” (“And now I’m putting ‘never’ because of the baby”) reflected uncertainty about the period being referenced.Clarified time frame added:
“¿Con qué frecuencia consume alguna bebida alcohólica actualmente?”/“How often do you currently consume any alcoholic beverages?”
Question: “¿Alguna vez le realizaron una mamografía?”/“Have you ever had a mammogram?”Some participants were unfamiliar with the term “mammography”, asking “¿Qué es eso?” (“What is that?”), indicating the need for a more inclusive or descriptive wording.Broader terminology introduced:
“¿Alguna vez le realizaron un estudio mamario (ecografía mamaria o mamografía)?”/“Have you ever had a breast study (breast ultrasound or mammogram)?”
Question: “¿Alguna vez le han realizado un examen mamario en consultorio?”/“Have you ever had a breast exam in a clinic?”Participants asked “¿Cómo?” and “No entiendo la pregunta” (“How?” and “I don’t understand the question”), indicating a lack of clarity regarding the procedure being referenced.Clarifying term added:
“¿Alguna vez le han realizado un examen mamario en consultorio? (palpado)”/“Have you ever had a breast exam in a clinic? (palpated)”
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Barral, P.E.; Miranda, A.R.; Soria, E.A. Co-Development and Content Validity of an Instrument to Collect Integratively the Social Determinants of Health in Postpartum Lactating People. World 2025, 6, 120. https://doi.org/10.3390/world6030120

AMA Style

Barral PE, Miranda AR, Soria EA. Co-Development and Content Validity of an Instrument to Collect Integratively the Social Determinants of Health in Postpartum Lactating People. World. 2025; 6(3):120. https://doi.org/10.3390/world6030120

Chicago/Turabian Style

Barral, Paula Eugenia, Agustín Ramiro Miranda, and Elio Andrés Soria. 2025. "Co-Development and Content Validity of an Instrument to Collect Integratively the Social Determinants of Health in Postpartum Lactating People" World 6, no. 3: 120. https://doi.org/10.3390/world6030120

APA Style

Barral, P. E., Miranda, A. R., & Soria, E. A. (2025). Co-Development and Content Validity of an Instrument to Collect Integratively the Social Determinants of Health in Postpartum Lactating People. World, 6(3), 120. https://doi.org/10.3390/world6030120

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