Development of two instruments for assessing maternity health needs: protocol of a clinimetric study

Becoming a parent is a life experience during which people are especially susceptible to modifying health-related habits [1, 2], which makes health education particularly relevant during this period. It is also a process of profound change, which requires numerous adaptations or restructuring at physical, psychological, social and economic levels [3]. These changes justify the presence of a certain level of anxiety about future challenges, threats and opportunities, as well as the search for guidance and support in Maternal Education (ME).

ME is therefore a complex health intervention, aimed not only at achieving a skillset and knowledge, but also at providing comprehensive support that favors self-management and self-care during pregnancy, childbirth, postpartum and child-rearing [4]. To achieve this, ME must be a dynamic, flexible intervention, constantly updated to adapt to the needs of women and the social contexts of the moment they are living through, and capable of giving a personalized, easily available response when the woman requires it.

In our current social context, pregnant women demand continuous, accessible, rigorous, personalized ME [5]. We also know that they systematically turn to the internet to search for information and advice about their pregnancy, regardless of their social and cultural level [6‐8], and that it may even be their main source of information, as in the case of highly qualified women professionals or immigrants, for whom attendance at ME sessions is not always feasible [9, 10].

Given this reality, the use of e-health in ME as a support tool for health decision-making can be useful for women, professionals and the health system [11, 12], as long as it is developed using an appropriate evidence-based methodology. The development of this tool must follow a strategy that considers both the resources and the needs and characteristics of the population which it is aimed at. Therefore, its protagonists (patients, professionals, the healthcare system, the community) should get involved to create a collaborative environment, transfer it to practical use, implement it, and evaluate the process through iterative cycles of continuous improvement [13]. The range of tools currently provided by the internet which respond to these quality requirements is practically non-existent [14].

The processes and components of health decision-making have been extensively studied [15] and all the theoretical models consider the importance of starting with the needs and resources of the patient. However, there are no valid, reliable measurement instruments that address needs during pregnancy, childbirth, postpartum and child-rearing from a comprehensive perspective which adapt to our context. Most of the measurement instruments that can be found in the bibliography aim to evaluate satisfaction, the effectiveness of professional action or the behavior of the population, with the aim of designing future strategies [16‐19].

Therefore, an e-health tool to support decision-making by women during the period of pregnancy, childbirth and puerperium should include self-assessment instruments for these needs. Since the range of needs that can arise during motherhood is infinite, it is necessary to prioritize those that are most relevant and require an immediate response. To this end, our research team carried out this prioritization through a Delphi and Nominal Group Technique Approaches study, defining eight topics as the highest priority [20]. In the current project, we intend to respond to two of these priority needs, designing valid, reliable and usable self-applied digital measurement instruments adapted to our context of 1) the needs of women preparing for childbirth and 2) the management of signs and symptoms in the puerperium.

A multidisciplinary group that combines midwives, nurses, pediatricians, epidemiologists, psychologists and pregnant and puerperal women participated in the construction of these instruments. A pool or universe of items was generated from the review and synthesis of the existing bibliography of the available measurement instruments for the different variables that influence coping with childbirth and the puerperium. The content validity and appearance of the test was studied through an iterative process based on the expert participants’ judgment. This group of experts was instructed in the criteria of scientific relevance, clarity, fit to the population and relevance of the scale of response proposed, in order to assess each item. The result was a consensual summary of the items considered relevant, clear and appropriate to the population, with pertinent measurement response options by at least 75% of the participants. This pool of items was transferred to digital format to continue the study.

The comprehensibility and ease of use of these two instruments was evaluated by a pilot test. Ten pregnant women at 37 weeks or more responded to the women’s needs measurement instrument for childbirth and assessed its comprehensibility and ease of use also. A further 10 women in the postpartum period (less than 42 days after delivery) responded to and assessed the comprehensibility and ease of use of the measurement instrument for normal symptoms in postpartum. Recruitment was carried out in the practice of the midwife of reference, who provided: 1. An informed consent form, 2. The link / access to the measurement instrument for the need being studied and 3. Four questions about the comprehension and ease of use of the tool, age and educational level. Any items where comprehensibility and ease of use were considered low by more than 20% of the women were eliminated and the measurement instruments were readjusted based on the comprehensibility of the items and global usability estimated from the pilot study.

The objective of the study is to evaluate the validity, reliability and ease of use of the two self-applied digital instruments for measuring the needs of women in childbirth and identifying alarm symptoms in the puerperium, by analyzing the universality or intergroup variation in the clinimetric parameters.

This project constitutes an essential step in the development of the “modeling, implementation and evaluation of new ME focused on the needs of women” in the multi-method line of other work [26], which will allow us to offer an effective response to real demands of women and their families in the current sociocultural context. These two measurement instruments will be integrated within the framework of this new ME, providing support at the two particularly critical moments of childbirth and postpartum.

Without a doubt, these measurement instruments will help women to identify what their health needs are and the personal resources they have for tackling these stages; they will help them recognize the warning signs and request the necessary help, as well as respond appropriately to normal signs and symptoms, thereby contributing to greater sustainability of the health system.

It is very likely that these instruments in digital format will be well received by the population, since citizens increasingly demand participation in decisions, greater autonomy in their relationship with the health services and greater agility responding to their needs [27, 28]. Furthermore, these instruments have been adapted to the needs of women and comply with the fundamental premise that the end user should participate in their creation [29].

It is thought that they will be well accepted by health professionals, since they are directly involved in their design, preparation and evaluation, thus responding to the limited and necessary participation of health professionals in the integration of care with new technologies [10, 30]. Furthermore, these instruments will provide professionals with valuable resources to meet the needs of the population more efficiently and guide decision-making throughout this stage, contributing to the improvement of prenatal and postnatal care [26] and to a service that is more rewarding for professionals.

We understand that these instruments for self-management of health needs must have a digital support to allow them to be agile and accessible at any time from different devices. Furthermore, the digital nature of the instruments will facilitate health data collection [12], which can guide new interventions and adapt the instruments to the demands of women and their families, since a digital format allows quick changes, flexibility and dynamism.

These instruments will be integrated into a much more complete e-health tool that aims to provide resources to a health system that aims to include the user’s perspective within the care it provides [31]. It is a tool that may be essential in situations of social distancing and restrictions on people’s mobility, such as those we have experienced with the COVID 19 pandemic [32, 33].

The pre-implementation study will make it possible to obtain instruments that, in addition to being valid, are usable and feasible for the women they have been designed for and for healthcare professionals in their daily work. Therefore, we have models such as that proposed by the Medical Research Council, which describe the design of this type of complex intervention, taking into account the variables that make them up, and their development and implementation [34, 35], taking into account the context in which they are to be implanted [36, 37].

In the future, the extension of these two instruments to the rest of the population will be simple, since many health services usually use digital resources in which they can be included. Adaptation to different types of populations will also be feasible, which is especially relevant considering that some population groups hardly access any of the current educational activities.

In terms of the study’s limitations, it could be seen as a sample that will be selected in a non-random way, although we do not see its representativeness as compromised, given the participation of several health centers with different socioeconomic levels, the consecutive recruitment of women, and privacy for each woman to answer the questionnaire. Another possible limitation, which is frequent in clinical studies, is the difficulty of uptake due to tiredness or lack of time among the professionals who have to implement it. In our study, the involvement of these professionals right from the design stage would facilitate gathering the necessary sample.

The final product will be two valid, reliable and usable instruments for self-assessment of health needs, which will be highly accepted by young couples and by the professionals who care for them and which will contribute to the greater sustainability of the health system.