Assessment of Quality of Life in Gestational Diabetes Mellitus Care—Study Protocol of the GDM-QOL Project
Abstract
:1. Introduction
2. Relevance
- (1)
- Improvement of quality and outcomes of GDM careBy conducting frequent QoL measurements with our GDM-specific questionnaire, we can provide a comprehensive understanding of the pregnant women’s personal living conditions. In our prospect, this means that this questionnaire has to be filled in as promptly as possible after the pregnant women are diagnosed with GDM and subsequently approximately every two weeks, e.g., in line with their regular obstetrical appointments. Throughout this process, clinicians are able to identify the women’s expectations, special health care needs, treatment difficulties, and impairments in everyday life early on, allowing for appropriate interventions, even if the woman is not willing or able to talk about certain topics with her attending obstetrician. By this means, obstetricians will be able to choose personalized treatment options based on each woman’s unique living conditions and to offer tailored information, targeted support, and psychological counseling, which will optimize the care provided to each woman. The resulting improvement in QoL instills a sense of security and trust in the attending physician and treatment procedures, empowering the women to actively participate in the therapeutic process, ultimately leading to high levels of satisfaction with the GDM care received [6,7,11,13,14,16].
- (2)
- Quantitative evaluation and improvement of diagnostic and therapeutic proceduresSimilar to other disease-specific questionnaires, our GDM-specific questionnaire will assess relevant health aspects and detect even minimal changes in a patient’s health status and health-related concerns in more detail and depth. This will enable a sensitive measurement of the pregnant women’s QoL, which holds significant practical importance for the comparison of diagnostic or therapeutic approaches in GDM care. For instance, our questionnaire could be used for cause analysis in the comparison of one therapeutic (or diagnostic) procedure against another, e.g., when both procedures are equal in their theoretical outcome, but one of them has been shown to be superior in a clinical setting via a much better adherence and overall outcome. Based on the assessment of the women’s health-related QoL with our questionnaire, it would be possible to show that the procedure that performs worse has a major negative impact on the women’s QoL, which is why the gestational diabetics discontinue their therapy and, therefore, have a worse outcome. Additionally, the questionnaire would be able to examine the proper reasons for the occurring differences in a clinical setting via a precise analysis of the women’s treatment-related concerns or problems with the new therapy, which lowers their QoL in such a way that they all continue their new therapy erratically or even discontinue it altogether. For instance, a pregnant woman could interrupt her newly administered insulin because of concerns that it might harm her fetus, because of reoccurring hypoglycemia symptoms, or because it is inconvenient for her to inject it at work, on the train, or in a restaurant. Hereby, copious interviews with probands and further test stages for causal research could be avoided [6,7,9,16]. This example shows that a solid and scientifically sound evaluation of the diagnostic and therapeutic procedures is of great importance, particularly in the context of health economics. Additionally, new technological advancements such as continuous glucose monitoring systems and insulin pumps, new medications, new lifestyle intervention strategies, or app-based monitoring methods, specifically designed for gestational diabetics, could be compared to the current standard GDM care with respect to their impacts on pregnant women’s health-related QoL by using our GDM-specific questionnaire. Thus, the most progressive diagnostic and therapeutic procedures could be chosen based on women’s QoL as one of the main metrics.
- (3)
- Shift of focus regarding primary outcome objectivesTraditionally, metabolic control and a favorable clinical outcome for a mother and her newborn were the primary therapy goals in GDM treatment. However, in recent years, a shift has occurred, emphasizing the need for a comprehensive assessment of women’s health and its appreciation as a whole. Instead of solely focusing on physical treatment goals, this shift highlights women’s perspectives on their conditions and the challenges they face in dealing with them [13,14]. For this reason, it was recommended to acknowledge the improvement of QoL as an equally important therapeutic goal as metabolic control and avoiding complications. Furthermore, it was suggested that future therapy optimization and adjustments should not only be based on physical factors but also on the individual circumstances of living and the patient’s biopsychosocial status [13]. Similarly, the WHO promotes a holistic health care approach whose primary goal is the patient’s well-being [16]. The same applies to the field of research: For many years, studies on GDM exclusively focused on the medical management and the risks for both mother and fetus, while only a few have explored how women with GDM experience their pregnancies and how the condition influences their QoL and perception of health [11,14]. Albeit QoL was increasingly measured in clinical research revolving around GDM over the years, these studies were not primarily intended to increase women’s QoL. Hence, their health-related QoL seemed to be more of a byproduct or a secondary outcome rather than the researchers’ primary focus of interest [7,14]. Given the higher vulnerability of women suffering from GDM, its continuously increasing prevalence, and the prospective provision of our GDM-specific questionnaire for QoL measurement, it would be appropriate to consider QoL as the main focus of intervention studies more frequently—recognizing its significance for expectant mothers and empowering them to enjoy their pregnancy with minimal stress under the given constraints.
3. Materials and Methods
3.1. Ethics
3.2. Aims of the Study
- Translation of the Persian questionnaire GDMQ-36 [10] after gaining permission: forward and backward translation via native speaker and translation agency.
- Expert ratings and pretests with cognitive debriefings and structured interviews with women suffering from GDM for the evaluation of comprehensibility, face and content validity.
- Pilot testing and validation of the preliminary questionnaire to investigate the psychometric performance of the measures in terms of validity and reliability.
3.3. Design and Methods
3.4. Study Participants
3.4.1. Sample Size
- For the expert ratings, we will include internal and external medical personnel, including gynecologists/obstetricians, endocrinologists, diabetes nurses, midwives, and dieticians. They will be contacted via email or orally. We aim for a total of 20 experts (n = 10 each, internal and external).
- Moreover, we will perform two pretests with women suffering from GDM. In the first cognitive debriefing, our focus will be on recruiting n = 30 patients, taking into account the common distribution of three main factors: normal weight vs. obesity, nullipara vs. multipara, and dietary vs. insulin treatment [17]. After a cultural and linguistic adaptation of the questionnaire, we will conduct another cognitive debriefing with patients until we accomplish a satiation of information assets. Roughly, we will try to obtain at least n = 10 patients.
- There are still unknown factors such as the exact size of the item pool and item communalities as well as the number and eigenvalues of the factors to calculate the exact sample sizes needed for piloting and validating the instrument. However, we assume an estimated item pool of approximately 40 ± 10 items, and the approximate ratio of the number of cases to items is roughly 4:1 (ranging from 3:1 to 5:1). Thus, for the piloting and validation study, we need a sample size of n = 200 women with GDM, based on complex psychometric procedures like the planned confirmatory factor analysis. This number of cases seems to be sufficient for the analyses to be performed.
3.4.2. Recruitment
3.4.3. Study Assessment and Measures
3.5. Data Evaluation
3.5.1. Data Collection and Management
3.5.2. Data Analysis
4. Discussion
- (1)
- Patient-driven re-conceptualization:In cognitive debriefings and structured interviews, the pregnant women could potentially reveal a couple of relevant subjects that concern them and thereby influence their QoL adversely, which may not have been covered in other instruments. Otherwise, it is conceivable that in the end some aspects, which one currently attributes great impact to, could be less important for women than previously thought. If this presumption comes true, our GDM-specific questionnaire will be able to capture the very aspects that are actually influencing the QoL of pregnant women with GDM.
- (2)
- Disease-specific assessment:Through the questionnaire, the women’s individual expectations, needs, impairments, problems, and experiences regarding different treatment options or struggles with lifestyle changes (e.g., healthier nutrition, increased exercise) can be assessed more sensitively than with other QoL questionnaires. Through the application of the GDM-specific instrument, women’s overall QoL or the impact of a particular intervention on it can be assessed more accurately due to the sensitivity of this disease-specific measure [8,10].
- (3)
- Tailored health care:Especially in lifestyle diseases such as GDM, there is a necessity to assess each woman’s needs individually: On the one hand, there are aspects that women with GDM are worried about or feel insecure about, such as implementing blood sugar measurements, insulin therapy, or managing the consumption of certain foods. As a result, they may need assistance and support in these areas. On the other hand, there are aspects they can handle very well on their own without further need for support. By facilitating a broader perspective of the pregnant woman’s personal viewpoint and attitudes, our GDM-specific questionnaire enables physicians to establish an individualized treatment plan and to allocate customized information, targeted support, and psychological counseling, which help to optimize and tailor the provided care to the personal needs and individual expectations of each pregnant woman [11,13]. Furthermore, these selective measures facilitate an efficient use of human resources in times of a shortage of physicians and other medical personnel.
- (4)
- Care-relevant evaluation:Finally, this instrument allows for the assessment of the impact of certain procedures and interventions on women’s QoL, enabling precise comparisons of treatment options, targeted interventions, and the development of new therapies to become possible [7,10,16]. In addition, inconsistent study findings regarding QoL in GDM could be re-evaluated, which would make studies on this topic more comparable as well as more valid and reliable [10].
5. Limitations of the Study
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
QoL | Quality of Life |
GDM | Gestational Diabetes Mellitus |
GDMQ-36 | Gestational Diabetes Mellitus Questionnaire 36 |
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Study Assessments and Measures | Number of Items | Study Time Points | |||
---|---|---|---|---|---|
Pilot Study | Retest I | Validation Study | Retest II | ||
General information | |||||
| 14 | x | x | ||
| 14 | x | x | ||
Psychological instruments | |||||
| 69 | x | x | x | x |
| 26 | x | x | ||
| 6 | x | x | ||
| 12 | x | x | ||
| 20 | x | x |
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Güldner, L.; Greffin, K.; Muehlan, H.; Stubert, J. Assessment of Quality of Life in Gestational Diabetes Mellitus Care—Study Protocol of the GDM-QOL Project. Healthcare 2024, 12, 1. https://doi.org/10.3390/healthcare12010001
Güldner L, Greffin K, Muehlan H, Stubert J. Assessment of Quality of Life in Gestational Diabetes Mellitus Care—Study Protocol of the GDM-QOL Project. Healthcare. 2024; 12(1):1. https://doi.org/10.3390/healthcare12010001
Chicago/Turabian StyleGüldner, Lisa, Klara Greffin, Holger Muehlan, and Johannes Stubert. 2024. "Assessment of Quality of Life in Gestational Diabetes Mellitus Care—Study Protocol of the GDM-QOL Project" Healthcare 12, no. 1: 1. https://doi.org/10.3390/healthcare12010001