Does fetal fibronectin use in the diagnosis of preterm labor affect physician behavior and health care costs? A randomized trial.

OBJECTIVE: The purpose of this study was to determine whether a knowledge of fetal fibronectin results affects patient treatment and health care costs. STUDY DESIGN: Women between 24 and 34 weeks of gestation with a singleton pregnancy and preterm uterine contractions were eligible for enrollment. Once informed consent was given, a fetal fibronectin specimen was obtained, and women were assigned randomly into 2 groups. In 1 group, results of the fetal fibronectin test were available; in the other group, results were not available. The use of inpatient and outpatient health care resources subsequent to enrollment was ascertained through the use of medical records, hospital billing data, and patient interviews. This study was powered to allow the detection in the fetal fibronectin group of a 20% reduction in total health care-related costs. RESULTS: The 2 groups were similar with respect to maternal age, parity, race, cervical examination at admission, and estimated gestational age at enrollment and at delivery. Women who did not have fetal fibronectin results available were no different than those women who did with respect to initial length of labor and delivery observation (median, 4 hours vs 3 hours), hospital admission (28% vs 26%), tocolysis (18% vs 16%), cessation of work (27% vs 26%), or total health care-related costs (log mean +/- SD, 7.6 +/- 1.2 vs 7.5 +/- 1.1). CONCLUSION: In this study population, the use of fetal fibronectin did not affect physician behavior or health care costs related to preterm contractions.

Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy.

The purpose of this study was to validate the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire. The FACT/GOG-Ntx is the FACT-G plus an eleven-item subscale (Ntx subscale) that evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. Two groups of women with ovarian cancer completed the FACT/GOG-Ntx: one group with known neurotoxicities and one group of chemotherapy-naive women newly diagnosed with ovarian cancer. Levels of patient neuropathy, severity of toxicity, and patient quality of life from diagnosis of ovarian cancer to 12 months post-diagnosis were assessed. The Ntx subscale significantly differentiated the two groups at baseline and 3- and 6-month follow-ups, demonstrating significantly fewer problems among chemotherapy-naive patients than among patients with known neuropathy. The FACT/GOG-Ntx is a reliable and valid instrument for assessing the impact of neuropathy on health-related quality of life. The Ntx subscale demonstrated sensitivity to meaningful clinical distinctions and change over time.

Preference assessment of prenatal diagnosis for Down syndrome: is 35 years a rational cutoff?

OBJECTIVE: To compare the perceptions of miscarriage and birth of a child with Down syndrome among pregnant women and to evaluate the implications of these preferences for the traditional 35-year old maternal age risk boundary. METHODS: An interviewer-administered survey was given to 186 pregnant women receiving antepartum care at a university hospital. Preferences, as reflected by utilities, for birth of a child with Down syndrome and pregnancy miscarriage, stratified by patient characteristics, were assessed. RESULTS: The utility for the birth of a child with Down syndrome decreased (p < 0.001) as clinical severity increased from mild (0.78) to severe (0.65). Miscarriage of a pregnancy had a mean utility of 0.76 +/- 0.31. Women who desired prenatal diagnosis had a utility value for miscarriage (0.79 +/- 0.28) that was significantly higher than for the birth of a child with Down syndrome of unknown severity (0.73 +/- 0.27). In multivariable logistic regression, desire for prenatal diagnosis was the only factor associated with a preference of miscarriage over birth of an affected child (odds ratio 2.26, 95% confidence interval 1.03, 4.96). CONCLUSION: Women who desire prenatal diagnosis do not perceive the birth of a child with Down syndrome and a pregnancy miscarriage to be equivalent health states. This finding calls into question the rationale of the 35-year-old maternal age criterion and suggests that actual patient preferences should be better incorporated into the decision to offer definitive prenatal diagnosis.

Evaluating the total costs of chemotherapy-induced toxicity: results from a pilot study with ovarian cancer patients.

PURPOSE: While chemotherapy-related toxicities affect cancer patients' activities of daily living and result in large expenditures of medical care for treatment, few studies have assessed the out-of-pocket and indirect costs incurred by patients who experience toxicity. The objective of this study was to evaluate the feasibility of obtaining detailed and comprehensive cost information from patients who experienced neutropenia, thrombocytopenia, or neurotoxicity during treatment. METHODS: Ovarian cancer patients who experienced chemotherapy-associated hematologic or neurologic toxicities were asked to record detailed information about hospitalization, laboratories, physician visits, phone calls, home visits, medication, medical devices, lost productivity, and caregivers. Resource estimates were converted into cost units, with direct medical cost estimates based on hospital cost-accounting data and indirect costs (i.e., productivity loss) on modified labor force, employment, and earnings data. RESULTS: Direct medical costs were highest for neutropenia (mean of $7,546/episode), intermediate for thrombocytopenia (mean of $3,268/episode), and lowest for neurotoxicity (mean of $688/episode). Indirect costs relating to patient and caregiver work loss and payments for caregiver support were substantial, accounting for $4,220, $3,834, and $4,282 for patients who developed neurotoxicity, neutropenia, and thrombocytopenia, respectively. The total costs of chemotherapy-related neurotoxicity, neutropenia, and thrombocytopenia were $4,908, $11,830, and $7,550. CONCLUSION: Our study has shown that, with the assistance of patients who are experiencing toxicity, estimation of the total costs of cancer-related toxicities is feasible. Indirect costs, while not included in prior estimates of the costs of toxicity studies, accounted for 34% to 86% of the total costs of cancer supportive care.