Original articlePsychometric evaluation of health-related quality of life measures in women after different types of delivery
Introduction
Patient-reported outcomes, including health-related quality of life (HRQoL), have increasingly been incorporated in the evaluation of medical technology assessments. HRQoL is often defined as patient-reported functioning and well-being in the physical, psychological, and social domains. Generally, there are three types of HRQoL measures: (a) generic measures, intended for use both in general population surveys and in studies of patients with diverse health conditions, allowing for comparison of HRQoL scores across disease stages and diagnostic groups; (b) condition-specific measures, developed for use among specific patient population (e.g., cancer, diabetes); and (c) domain-specific measures, for measurement of specific symptoms (e.g., fatigue, pain). It is common practice to combine condition-specific and/or domain-specific measures with generic measures. The feasibility and other psychometric properties of HRQoL measures, however, may differ between populations.
The birth of a child has a major impact on the new mother. Her HRQoL is influenced by a variety of medical, psychological, social, and obstetric factors (e.g., her age, general physical health during pregnancy, length of labor, maternal expectations, beliefs, attachment, and mood). Traditionally, the postpartum period is considered to be 6 weeks [1]. Longitudinal studies measuring HRQoL postpartum show serious physical and emotional problems in more than 50% 1 year postpartum [2], [3]. Some of these symptoms are still present more than 12 months postpartum [4]. HRQoL in patients after vaginal delivery (VD) was found to be significantly different from HRQoL in women after cesarean section (CS) [3]. With a prevalence of 60–70%, fatigue is the most frequent symptom after 1 year [2], [4]. To date, studies about fatigue and HRQoL in the immediate postpartum period are lacking.
Blood loss during delivery is one of the most frequently occurring delivery-related complications that may have consequences for maternal HRQoL in the immediate postpartum period and thereafter, for example, because of excessive fatigue [5]. Red blood cell (RBC) transfusion is one of the primary treatments for postpartum anemia. In general, the medical ground for an RBC transfusion is based on Hb triggers [6]. The aim of RBC transfusions postpartum is, however, not to increase Hb values but to improve HRQoL. With the exception of extremely low Hb levels, there is no medical need to restore a low Hb level with RBC transfusions directly postpartum. Moreover, a blood transfusion is a generally safe procedure but it is not completely without risks [7], [8].
However, HRQoL data are currently not applied in clinical decision-making process regarding blood transfusions in the postpartum period. Therefore, we started a prospective randomized study comparing a novel RBC transfusion policy after delivery and usual care—the WOMB study (Well-being of Obstetric Patients on Minimal Blood Transfusions; ClinicalTrials.gov identifier: NCT00335023). HRQoL is the primary outcome measure in the WOMB study. Preceding the start of the WOMB study, we tested the appropriateness of various HRQoL measures, including the domain-specific Multidimensional Fatigue Inventory (MFI) for fatigue and two generic measures [Short Form 36 (SF-36) and the EQ-5D classification of own health], among women after VD, elective CS, and emergency CS. This study aimed to assess, in a clinical obstetrical setting, the following:
- 1.
the feasibility of the MFI, SF-36, and EQ-5D (indicators: response rate, missing/nonunique answers, reported difficulties, and completion time);
- 2.
the score distribution of the MFI, SF-36, and EQ-5D (mean scores, standard deviations, presence of floor and ceiling effects);
- 3.
the reliability of the scales of the MFI and SF-36 (internal consistency);
- 4.
the discriminative ability of the MFI, SF-36, and EQ-5D rating of own health between groups of women by type of delivery 1 week after delivery;
- 5.
the responsiveness over time of the MFI, SF-36, and EQ-5D rating of own health (differences between mean scores at T=0 and T=6 weeks and effect sizes); and
- 6.
the relationship between blood loss and MFI fatigue scores.
Section snippets
Patients
In the period June 2003 to March 2004, 71 consecutive patients after VD and 70 patients after CS were included in two university hospitals and in one general hospital in Rotterdam and Leiden (the Netherlands). Patients undergoing CS were post hoc divided into those undergoing an elective CS (n=36) and those undergoing an emergency CS (n=34). Indications for elective CS were breech and transverse presentation, two or more previous CS, previous anorectal surgery, maternal condition, and a
Feasibility
A total of 55% of the patients returned all HRQoL measures, 16% returned three questionnaires, 9% returned two questionnaires, and 20% returned only the first questionnaire. Of the Dutch ethnic patients, 70% returned all questionnaires, whereas only 44% of the non-Dutch ethnic patients returned all questionnaires. For all different time points combined, the mean amount of missing values (range) of the returned HRQoL measures was 1.8 (0–4) for the MFI, 1.1 (0–3) for EQ-5D classification,
Discussion
This evaluation of the international standard HRQoL measures MFI, EQ-5D, and SF-36 established the feasibility, reliability, and validity of these measures in a clinical obstetric setting. This study supports the discriminative ability of these measures by type of delivery and provides reference (norm) scores for patients after delivery.
Different HRQoL measures are used in studies with patients after delivery [25], [26], [27], [28]. However, no psychometric evaluation of HRQoL measures has been
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