Bat-Sheva Levine

A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial

OBJECTIVEnTo determine the value of gonadotropin/intrauterine insemination (FSH/IUI) therapy for infertile women aged 21-39 years.nnnDESIGNnRandomized controlled trial.nnnSETTINGnAcademic medical center associated with a private infertility center.nnnPATIENT(S)nCouples with unexplained infertility.nnnINTERVENTION(S)nCouples were randomized to receive either conventional treatment (n=247) with three cycles of clomiphene citrate (CC)/IUI, three cycles of FSH/IUI, and up to six cycles of IVF or an accelerated treatment (n=256) that omitted the three cycles of FSH/IUI.nnnMAIN OUTCOME MEASURE(S)nThe time it took to establish a pregnancy that led to a live birth and cost-effectiveness, defined as the ratio of the sum of all health insurance charges between randomization and delivery divided by the number of couples delivering at least one live-born baby.nnnRESULT(S)nAn increased rate of pregnancy was observed in the accelerated arm (hazard ratio [HR], 1.25; 95% confidence interval [CI], 1.00-1.56) compared with the conventional arm. Median time to pregnancy was 8 and 11 months in the accelerated and conventional arms, respectively. Per cycle pregnancy rates for CC/IUI, FSH/IUI, and IVF were 7.6%, 9.8%, and 30.7%, respectively. Average charges per delivery were

Iodine-Induced Hypothyroidism in Full-term Infants With Congenital Heart Disease: More Common Than Currently Appreciated?

9,800 lower (95% CI,

Do HEDIS Measures Reflect Cost-Effective Practices?

25,100 lower to

Preoperative risk stratification of children with ovarian tumors

3,900 higher) in the accelerated arm compared to conventional treatment. The observed incremental difference was a savings of

Poor adherence to staging guidelines for children with malignant ovarian tumors.

2,624 per couple for accelerated treatment and 0.06 more deliveries.nnnCONCLUSION(S)nA randomized clinical trial demonstrated that FSH/IUI treatment was of no added value.

Early Identification of Primary Hypothyroidism in Neonates Exposed to Intra-Lymphatic Iodinated Contrast: A Case Series.

CONTEXTnIodine is a micronutrient essential for thyroid hormone synthesis. Thyroid hormone is critical for normal neurocognitive development in young infants, and even transient hypothyroidism can cause adverse neurodevelopmental outcomes. Both iodine deficiency and excess can cause hypothyroidism. Although iodine-induced hypothyroidism is well recognized in premature infants, full-term neonates have received less attention. Infants with congenital heart disease (CHD) are commonly exposed to excess iodine from administration of iodinated contrast agents during cardiac catheterization as well as topical application of iodine-containing antiseptics and dressings; hence, this is a vulnerable population.nnnOBJECTIVEnWe report three cases of iodine-induced hypothyroidism in full-term neonates with CHD after cardiac angiography and topical application of iodine-containing antiseptics and dressings in the operative setting.nnnRESULTSnThree neonates with CHD and normal thyroid function at birth developed hypothyroidism after exposure to excess iodine. Two of these infants had transient hypothyroidism, and one had severe hypothyroidism requiring ongoing thyroid replacement therapy. All infants were asymptomatic, with hypothyroidism detected incidentally in the inpatient setting due to repeat newborn screening mandated by the long duration of hospitalization in these infants.nnnCONCLUSIONSnIodine-induced hypothyroidism may be under-recognized in infants with CHD exposed to excess iodine. Systematic monitoring of thyroid function should be considered to avoid potential long-term adverse neurodevelopmental effects of even transient thyroid dysfunction in this susceptible population.

Hypothyroidism in Infants With Congenital Heart Disease Exposed to Excess Iodine

PURPOSEnWhether the Health Plan Employer Data and Information Set (HEDIS) performance measures for managed care plans encourage a cost-effective use of societys resources has not been quantified. Our study objectives were to examine the cost-effectiveness evidence for the clinical practices underlying HEDIS 2000 measures and to develop a list of practices not reflected in HEDIS that have evidence of cost effectiveness.nnnDATA SOURCESnTwo databases of economic evaluations (Harvard School of Public Health Cost-Utility Registry and the Health Economics Evaluation Database) and two published lists of cost-effectiveness ratios in health and medicine.nnnSTUDY SELECTIONnFor each of the 15 effectiveness of care measures in HEDIS 2000, we searched the data through 1998 for cost-effectiveness ratios of similar interventions and target populations. We also searched for important interventions with evidence of cost-effectiveness (<

RASopathies Are Associated With Delayed Puberty; Are They Associated With Precocious Puberty Too?

20,000 per life-year [LY] or quality-adjusted life year [QALY] gained), which are not included in HEDIS. All ratios were standardized to 1998 dollars. The data were collected and analyzed during fall 2000 to summer 2001.nnnDATA EXTRACTIONnCost-effectiveness ratios reporting outcomes in terms of cost/LY or cost/QALY gained were included if they matched the intervention and population covered by the HEDIS measure.nnnDATA SYNTHESISnEvidence was available for 11 of the 15 HEDIS measures. Cost-effectiveness ranges from cost saving to

Reducing Acute Adverse Outcomes in Youths With Type 1 Diabetes: A Randomized, Controlled Trial

660,000/LY gained. There are numerous non-HEDIS interventions with some evidence of cost effectiveness, particularly interventions to promote healthy behaviors.nnnCONCLUSIONSnHEDIS measures generally reflect cost-effective practices; however, in a number of cases, practices may not be cost effective for certain subgroups. Data quality and availability as well as study perspective remain key challenges in judging cost effectiveness. Opportunities exist to refine existing measures and to develop additional measures, which may promote a more efficient use of societal resources, although more research is needed on whether these measures would also satisfy other desirable attributes of HEDIS.

Medicare’s National Coverage Decisions, 1999–2003: Quality Of Evidence And Review Times

BACKGROUNDnThe appropriate operative approach to pediatric patients with ovarian tumors must balance real risk of malignancy with maximal preservation of reproductive potential. We evaluate preoperative risk of malignancy in order to more precisely guide treatment, so as to err on the side of ovarian preservation if at all possible.nnnMETHODSnWe retrospectively reviewed the records of all patients undergoing surgical intervention for ovarian tumors at a single institution. The primary endpoint was ovarian malignancy.nnnRESULTSnOf 502 patients who underwent surgery for ovarian tumors, 44 (8.8%) had malignancies. Malignancy rate (95% confidence interval) was low for cystic lesions <9cm (0.0%, 0.0-2.9%) and for tumor marker-negative heterogeneous lesions <9cm (2.3%, 0.4-12.1%). High-risk profiles for malignancy included tumor marker-positive heterogeneous lesions (66.7%, 35.4-87.9%) and solid tumors ≥9cm (69.2%, 16.2-40.3%). Intermediate risk tumors included cystic tumors ≥9cm (6.8%, 3.5-20.7%), tumor marker-negative heterogeneous lesions ≥9cm (31.2%, 18.0-48.6%), and solid tumors <9cm (11.1%, 4.4-25.3%).nnnCONCLUSIONSnWe developed a decision strategy to help determine who may and may not require an ovarian-sparing approach, which warrants prospective application and validation. Ultimately, the decision to pursue an oncologic surgery with oophorectomy and staging (as opposed to fertility-preserving surgery) should be made after individualized discussion involving the surgeon, patient, and family.