Proxy ratings of health related quality of life in patients with hepatocellular carcinoma

The present study prospectively assessed consistency of ratings of health-related quality of life between patients with hepatocellular carcinoma and two types of proxy raters, family caregivers and oncologist care providers. Patients and proxies completed the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) at baseline prior to treatment (82 patients plus proxies), at 3-months (32 patients plus proxies), and 6-months follow up (16 patients plus proxies) after diagnosis. Patient and proxy demographic data and patient medical data were also collected. At baseline, significant intra-class correlations (ICC) were found for patient–caregiver ratings of physical, social/family, and functional well-being, additional concerns (symptoms, side effects), and overall health related quality of life (HRQL); for patient–care provider ratings of physical well-being; and for caregiver–care provider ratings of physical and emotional well-being. At 3-months follow-up, the most significant number of ICCs were recorded across all three rater pairs. Significant consistencies were found for overall HRQL, and all subscale scores except for social and family well-being. The fewest significant ICCs were found at the 6-month follow-up, and were for patient–caregiver ratings of physical and functional well-being, and additional concerns; and for caregiver–care provider ratings on overall HRQL. These results suggest that family caregivers are adequate proxies of patient physical and functional well-being and additional concerns throughout the patients illness, more so than oncologist care providers. Further research is warranted with larger samples.     

The use of additional imaging increased specificity and decreased sensitivity in screening mammography

BACKGROUND AND OBJECTIVES: To examine the use of additional imaging after standard mammographic screening views to better understand the value of these additional testing in improving accuracy. MATERIALS AND METHODS: Statewide population data on screening mammography were used to report accuracy measures at screening and after additional imaging tests. Pathology data from biopsies performed within 1 year following the screening mammogram were used to determine cancer outcome (489 in situ and invasive cancers). Pathologic and population characteristics of women receiving different types of imaging were assessed by chi-square or t-tests. Similar tests compared women with the same imaging and differing outcomes. RESULTS: Of 77,799 women with screening mammograms 9.9% had additional imaging. Additional imaging reduced false positives from 7,765 (100/1,000 mammograms) to 1,112 (14/1,000 mammograms). The majority of false negatives (82%) occurred in women receiving only screening views, and additional imaging increased the number of false negatives from 82 (1/1,000 mammograms) to 115 (1.5/1,000 mammograms). CONCLUSION: Additional imaging can reduce unnecessary biopsy but at the cost of some additional false negatives. Additional imaging's potential for improving the sensitivity of screening is limited because most missed cancers occur in women who do not have additional imaging.     

Ghrelin receptor gene: identification of several sequence variants in extremely obese children and adolescents, healthy normal-weight and underweight students, and children with short normal stature

GH secretagogue receptor (GHSR, ghrelin receptor) is involved in regulation of body weight and GH secretion. We initially analyzed two single-nucleotide polymorphisms of the GHSR in up to 184 extremely obese children and adolescents and up to 184 healthy underweight students. The frequency of the 171T allele of rs495225 was higher in our obese samples (75.0%) than in the underweight individuals (70.2%; nominal P = 0.14). This trend could not be substantiated in an additional association study in 270 obese and 145 underweight and normal weight individuals and in a transmission disequilibrium test based on 387 obesity trios (transmission rate of 171T, 51.8%; nominal P = 0.53). Additionally, the coding region of GHSR was systematically screened, and seven sequence variants were identified in 93 obese, 96 normal weight, and 94 underweight individuals and 43 children with short normal stature (SNS). Five silent single-nucleotide polymorphisms showed similar genotype frequencies in the different weight groups and SNS children (all nominal P > 0.3). Two novel missense variants were detected only in one obese carrier and one SNS child, respectively. In conclusion, we did not obtain conclusive evidence for an involvement of the ghrelin receptor gene in body weight regulation or SNS in our study groups.     

Initiating a novel therapy in preventing postpartum hemorrhage in rural India: a joint collaboration between the United States and India

BACKGROUND: Maternal mortality rates in India are estimated at 560/100,000 live births and postpartum hemorrhage (PPH) accounts for 35-56% of these deaths. Given that 50% of births in rural India occur at home, oral Misoprostol administered by minimally trained midwives may be an effective uterotonic agent for preventing PPH when the use of other uterotonics is not feasible. While the import for testing the effectiveness of this intervention may be readily obvious, the elements essential for the conduct of a scientific study in rural areas served by indigenous health workers may not be as evident. METHODS: We present the design as well as the preparation and development of an ongoing NICHD sponsored U.S.-Indian collaborative randomized, placebo-controlled, clinical trial (RCT) conducted in four Primary Health Center areas of Belgaum District, Karnataka, India. The primary goal of the trial is to assess the effectiveness of Misoprostol 600 microg orally in reducing the incidence of acute PPH (> or = 500 mL) in women delivering at home or in neighboring sub-centers. 1600 pregnant women will be randomized to receive Misoprostol or placebo immediately post-delivery of the infant. However, beyond testing the scientific merit of the RCT, this study also tests the feasibility of having indigenous midwives regularly using Misoprostol in rural areas as well as the willingness of these communities to accept this intervention. In addition, this paper also explores the international and community collaborations necessary for the conduct of this study. FINDINGS: It is necessary to have several critical elements in place, including international collaboration between the Indian and US research sites, funding through a private/public collaboration and trained scientists, as well as commitment from the community for the successful conduct of such a study. In the development and implementation of a RCT, careful attention must be paid to the training of field personnel involved in the delivery process and developing a data collection and monitoring system to ensure that information gathered is valid. CONCLUSIONS: A joint U.S.-Indian collaboration to test the efficacy and the feasibility of an innovative method to reduce PPH can serve as collaborative model to develop additional interventions to improve maternal mortality and morbidity. If Misoprostol is shown to be sufficiently safe and efficacious in the prevention of PPH, the appropriate government agencies will be encouraged to make the drug available to midwives (ANMs) and rurally located physicians for whom parenteral medications are either not permitted or impractical and/or unavailable. Such a project can serve as a model applicable to rural settings throughout the developing world for improving delivery practices and reducing maternal mortality and morbidity. These are important public health concerns in India and other developing nations.     

The continuum of maternal morbidity and mortality: factors associated with severity

OBJECTIVE: The goal of this study was to examine whether sociodemographic, clinical, and other service-related factors, as well as preventability issues affect a woman's progression along the continuum of morbidity and mortality. STUDY DESIGN: This was a case-control study of pregnancy-related deaths, women with near-miss morbidity, and those with other severe, but not life threatening, morbidity. Factors associated with maternal outcome were examined. RESULTS: Provider factors (related to preventability) and clinical diagnosis were significantly associated with progression along the continuum after controlling for sociodemographic characteristics (P < .01 for both associations). CONCLUSION: In order to improve mortality rates, we must understand maternal morbidity and how it may lead to death. This study shows that important initiatives include addressing preventability, in particular, provider factors, which may play a role in moving women along the continuum of morbidity and mortality.     

International Classification of Diseases-9th revision coding for preeclampsia: how accurate is it?

OBJECTIVE: The purpose of this study was to evaluate the accuracy of the International Classification of Diseases-9th revision codes for preeclampsia and eclampsia. STUDY DESIGN: The University of Illinois Medical Center at Chicago discharge database was used to identify 135 women from 1999 through 2001 whose disease was coded as having preeclampsia or eclampsia. With American College of Obstetrics and Gynecology criteria as the gold standard, the diagnosis that was determined through chart review was compared with the International Classification of Diseases-9th revision code that was present in the discharge database. Patients were classified as true cases if the International Classification of Diseases-9th revision code matched the American College of Obstetricians and Gynecologists diagnosis; the positive predictive value of the code was then calculated. RESULTS: The overall positive predictive value for the complete sample was only 54%, but the positive predictive value for severe preeclampsia was 84.8%, which was high compared with mild preeclampsia (45.3%) and eclampsia (41.7%). Diagnostic (clinician) error was the most common reason for miscoding error. CONCLUSION: The findings suggest that International Classification of Diseases-9th revision codes for preeclampsia/eclampsia vary greatly in their accuracy of diagnosis. Therefore, a review of medical records is required when data are being gathered on the incidence of preeclampsia and eclampsia.