The impact of monitoring techniques on progression to chronic breast cancer-related lymphedema: a meta-analysis comparing bioimpedance spectroscopy versus circumferential measurements.

BACKGROUND: Chronic breast cancer-related lymphedema (BCRL) is a potentially serious complication following treatment. Monitoring for progression to BCRL may allow for earlier detection and intervention, reducing the rate of progression to chronic BCRL. Therefore, the purpose of this meta-analysis is to evaluate the impact of monitoring techniques on the incidence of chronic BCRL among patients monitored by bioimpedance spectroscopy (BIS) and circumference as compared to background rates. METHODS: Eligible peer-reviewed studies from PubMed, CINHAL, or Google Scholar that were published in English from 2013 onward and conducted in North America, Europe, or Oceania. Incidence rates abstracted from studies were classified by BCRL monitoring method: background (no standardized BIS or circumference assessments), BIS or circumference. A random-effects model was used to calculate a pooled annualized estimate of BCRL incidence while accounting for clinical and methodological heterogeneity. Subgroup analyses examined differences in duration of follow-up as well as breast and axillary surgery. RESULTS: 50 studies were included, representing over 67,000 women. The annualized incidence of BCRL was 4.9% (95% CI: 4.3-5.5) for background studies (n = 35), 1.5% (95% CI: 0.6-2.4) for BIS-monitored studies (n = 7), and 7.7% (95% CI: 5.6-9.8) for circumference-monitored studies (n = 11). The cumulative BCRL incidence rate in BIS-monitored patients was 3.1% as compared to 12.9% with background monitoring (69% reduction) and 17.0% with circumference-monitored patients (81% reduction). CONCLUSIONS: Evidence suggests that monitoring with BIS allowing for early intervention significantly reduces the relative risk of chronic BCRL with a 69% and 81% reduction compared to background and circumference, respectively. Circumference monitoring did not appear to provide a benefit with respect to chronic BCRL incidence. Based on these results, BIS should be considered for BCRL screening in order to detect subclinical BCRL and reduce rates of chronic BCRL, particularly in high-risk patients.

The CHOICES Study: Facility Level Comparative Cost, Resource Utilization, and Outcomes Analysis of Myomectomy Compared to Transcervical Fibroid Ablation.

PURPOSE: The CHOICES study compared short-term resource utilization, facility costs, and perioperative patient outcomes between transcervical fibroid ablation (TFA) with the Sonata® system and myomectomy through a case-matched comparative trial design. This is the first facility-level comparative study conducted for TFA. PATIENTS AND METHODS: The study enrolled 88 patients from 4 centers equally divided among the two cohorts. The TFA arm consisted of 44 women who had enrolled in the SONATA Pivotal IDE trial, whereas the myomectomy arm included 44 patients who were identified through retrospective case-matching to the enrolled SONATA patients at the same 4 centers. RESULTS: TFA had a significantly lower mean operating room duration (90 minutes) and length of stay (5.2 hours) than myomectomy (143 minutes and 45.8 hours, respectively). The average total mean facility costs for TFA procedure ($7,563) were significantly lower than those associated with myomectomy ($11,425; p=0.002). TFA mean facility costs were also compared with other stratifications of myomectomy (inpatient or outpatient and surgical route). TFA facility costs were significantly lower than that associated with inpatient, abdominal, or laparoscopic myomectomy (all p<0.001). CONCLUSION: TFA using the Sonata system has a significantly shorter operating room time and length of stay than myomectomy for the treatment of symptomatic uterine fibroids. All procedure, anesthesia, laboratory, pathology, and pharmacy costs were significantly higher for myomectomy as compared to TFA. TFA was also associated with significantly lower facility procedure-related costs compared to myomectomy, including inpatient, abdominal, or laparoscopic myomectomy.

The INSPIRE Comparative Cost Study: 12-Month Health Economic and Clinical Outcomes Associated with Hysterectomy, Myomectomy, and Treatment with the Sonata System.

PURPOSE: The INSPIRE study compared perioperative and 12-month health economic and clinical outcomes associated with hysterectomy, myomectomy, and sonography-guided transcervical fibroid ablation (TFA) using the Sonata® system. PATIENTS AND METHODS: Cost and health care resource utilization (HCRU) data for TFA were obtained from a prospective, multicenter, single-arm clinical trial. Data for hysterectomy and myomectomy arms were derived from the Truven Health MarketScan commercial payer claims database. The Truven data was used to determine health economic outcomes and costs for the hysterectomy and myomectomy arms. For each arm, payer perspective costs were estimated from the available charge and HCRU data. RESULTS: TFA with Sonata had significantly lower mean length of stay (LOS) of 5 hrs versus hysterectomy (73 hrs) or myomectomy (79 hrs; all p< 0.001). The average payer cost for TFA treatment, including the associated postoperative HCRU was $8,941. This was significantly lower compared to hysterectomy ($24,156) and myomectomy ($22,784; all p< 0.001). In the TFA arm, there were no device- or procedure-related costs associated with complications during the peri- or postoperative time frame. TFA subjects had significantly lower costs associated with complications, prescription medications, and radiology. CONCLUSION: Compared to hysterectomy and myomectomy, TFA treatment with the Sonata system was associated with significantly lower index procedure cost, complication cost, and LOS, contributing to a lower total payer cost through 12 months.

The association between hydroxyurea treatment and pain intensity, analgesic use, and utilization in ambulatory sickle cell anemia patients.

BACKGROUND: We compared daily pain, home analgesic use, and utilization among ambulatory adults in the randomized multicenter study of hydroxyurea in sickle cell anemia (MSH). We related the fetal hemoglobin (HbF) hydroxyurea response to these response variables. METHODS: Patients rated their sickle cell pain intensity (0-9), use of analgesics, and visits for pain daily. Diaries were collected biweekly, and intensity was collapsed into single interval ratings. The interval proportions of days of analgesic use and medical visits for pain were also calculated. Group comparisons were made by intention to treat as well as by HbF change levels from baseline to 2 years of treatment (placebo and low, medium, high, or very high response). RESULTS: A total of 134 (44.8%) enrollees completed 2 years of follow-up. Pain intensity correlated with analgesic use (r = 0.83, P > 0.0001) and utilization (r = 0.50, P < 0.0001). Pain intensity was lower for patients on hydroxyurea (2.51 ± 0.062 vs 2.82 ± 0.063 placebo, F(1270) = 11.65, P = 0.0007). The difference, though small, appeared early and was sustained. Analgesic use and utilization were also slightly lower (analgesic use: F (1270) = 11.97, P = 0.0006; utilization: F(1270) = 32.0, P < 0.0001). Each was statistically significantly lower among hydroxyurea patients with higher HbF treatment responses to hydroxyurea. CONCLUSIONS: Hydroxyurea usage led to a small, statistically significant reduction in daily pain, analgesic use, and utilization in adults in MSH, corroborating previously shown larger reductions in crises and mortality. The degree of daily symptomatic reduction was related to the size of the HbF treatment response, further confirming HbF response as a useful laboratory correlate.

The impact of hydroxyurea on career and employment of patients with sickle cell anemia.

The purpose of this study was to determine the association between hydroxyurea treatment and changes in employment status, if any, among patients with sickle cell anemia enrolled in the Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH). To that end, we compared the employment status among treatment responders, treatment nonresponders, and placebo groups of patients enrolled in MSH during the clinical trial and follow-up periods. Treatment with hydroxyurea did not significantly (p > .05) affect employment status, but there was a trend for more consistent employment in the hydroxyurea group. Given the fact that patients enrolled in MSH had moderate to severe disease with irreversible complications such as avascular necrosis, if would be attractive to hypothesize that future treatment of young patients with hydroxyurea could prevent or mitigate the incidence of complications of sickle cell anemia and, hence, improve the employment status of treated patients.

Early detection of response to hydroxyurea therapy in patients with sickle cell anemia.

Red blood cells (RBC) and reticulocyte parameters were determined on peripheral blood from a subset of patients enrolled in the multicenter study of hydroxyuea (HU) in sickle cell anemia. Multiple blood samples were obtained every 2 weeks. Cellular indices were measured by flow cytometry. Generalized linear models were used to determine the relationship between the longitudinal trajectories of RBC and reticulocyte indices and HU usage. There was a significant relationship between HU usage and most of the RBC and reticulocyte indices. Hydroxyurea produced higher value trajectories than those generated by placebo usage for the hemoglobin (Hb) content of both the RBCs and reticulocytes and for the mean corpuscular volume (MCV) of reticulocytes. These changes were first detected 10 weeks after starting HU and before the increase in Hb F levels. The data suggest that subtle and early markers of response to HU reside in the hemogram.

Hydroxyurea and acute painful crises in sickle cell anemia: effects on hospital length of stay and opioid utilization during hospitalization, outpatient acute care contacts, and at home.

CONTEXT: Exploratory findings from the randomized, double-blind, placebo-controlled, multicenter study of hydroxyurea (MSH) in sickle cell anemia (SS). Recurrent acute painful crises may be mild, moderate, or severe in nature and often require treatment at home, in acute care facilities as outpatients, and in the hospital with oral and/or parenteral opioids. OBJECTIVES: The objectives of this study were to determine the effects of hydroxyurea (HU) on length of stay (LOS) in hospital and opioid utilization during hospitalization, outpatient acute care contacts, and at home. METHODS: Data from patient diaries, follow-up visit forms, and medical contact forms for the 299 patients enrolled in the MSH were analyzed. Types and dosages of at home, acute care, and in-hospital analgesic usage were explored descriptively. RESULTS: At-home analgesics were used on 40% of diary days and 80% of two-week follow-up periods, with oxycodone and codeine the most frequently used. Responders to HU used analgesics on fewer days. During hospitalization, 96% were treated with parenteral opioids, with meperidine the most frequently used; oxycodone was the most commonly used oral medication. The average LOS for responders to HU was about two days less than for other groups, and their cumulative time hospitalized during the trial was significantly less than for nonresponders or placebo groups (P<0.022). They also had the lowest doses of parenteral opioids during acute care crises (P=0.015). CONCLUSION: Beneficial effects of HU include shortening the duration of hospitalization because of acute painful episodes and reducing the net amount of opioid utilization.

Prospective associations among cereal intake in childhood and adiposity, lipid levels, and physical activity during late adolescence.

Cereal consumption is a common dietary behavior that has been associated with positive health outcomes. The objective of this study was to examine prospective associations between cereal intake in childhood and percent body fat, waist-to-hip ratio, lipid levels, and physical activity during late adolescence. In this longitudinal investigation (data collected 1987-1997), data were analyzed for the 2,379 girls who participated in the 10-year National Heart, Lung, and Blood Institute Growth and Health Study. The cumulative percent of days that each girl consumed cereal during childhood (based on 3-day food diaries collected during six study visits between ages 11.5 and 18.6 years) was examined in relation to percent body fat, waist-to-hip ratio, lipid levels, and physical activity measured at age 18.6 years. Results indicated that nearly all girls (90.1%) reported eating cereal and 18.7% reported eating cereal on half or more of the days reported in the food diaries. Girls who ate cereal on a greater percentage of days during childhood had lower percent body fat and total cholesterol, and were more likely to exhibit high levels of physical activity and less television viewing during Study Year 10 (P values<0.05). Further research should explore lifestyle issues related to cereal consumption.

Climatic and geographic temporal patterns of pain in the Multicenter Study of Hydroxyurea.

No multi-site comparisons have tested whether seasonally cold temperature or climate exacerbate pain intensity in sickle cell disease (SCD). We examined seasonal SCD pain intensity and frequency patterns and compared them with concurrent climate conditions (temperature and barometric pressure) and geography of patient residence in the Multicenter Study of Hydroxyurea (MSH). We conducted a time series analysis of the monthly average daily pain intensity (0-9 scale) and pain frequency of the 299 MSH patients from December 1991 to December 1994. We used both an unobserved component model (UCM) and a nonparametric local regression (LOESS) to probe for a cycle and/or trend associated with the time series. We also examined base mixed regression models of season, monthly average temperature and barometric pressure, and geographic region as stand-alone predictors of pain intensity and frequency. Expanded models included additional predictor variables. UCM and LOESS analyses showed a cyclic pattern of pain intensity and frequency with peaks in late Fall/early Winter and troughs in Spring. Base regression models showed colder seasons were significantly associated with greater pain intensity (p = .0035) but not frequency (p = .07); higher monthly temperatures were significantly associated with both lower pain intensity and pain frequency, but higher monthly barometric pressures were significantly associated with greater pain intensity and frequency (all p's < .0001); and northern sites had nonsignificantly higher pain intensity (p = .40) and frequency (p = .07) than southern sites. This pattern of results did not change in expanded models including other predictors. Our results suggest that seasonably colder temperatures exacerbate sickle cell-related pain, but low barometric pressure does not, and geographic region of residence is not significantly related to pain in this sample.

The relationship of ready-to-eat cereal consumption to nutrient intake, blood lipids, and body mass index of children as they age through adolescence.

OBJECTIVE: To examine sex differences and longitudinal changes in ready-to-eat (RTE) cereal and breakfast consumption in the Dietary Intervention Study in Children, and the relationship between RTE cereal intake with nutrient intake, blood lipids, and body mass index (BMI). DESIGN: Secondary analyses based on data from Dietary Intervention Study in Children, a randomized, controlled, multicenter, clinical trial with five sets of three 24-hour recalls. SUBJECTS/SETTING: Children (n=660) from six clinics aged 8 to 10 years at study entry. Participants had serum low-density lipoprotein cholesterol levels between the 80th and 98th percentiles for age, and were followed for a mean of 7.5 years. INTERVENTION: Children were randomized to a total fat- and saturated fat-modified dietary intervention or usual care. STATISTICAL ANALYSES: Frequency of RTE cereal and breakfast consumption was examined by sex and age. Mixed models by sex were used to examine the relationship of RTE cereal consumption to average daily intake of nutrients, blood lipids, and BMI. RESULTS: For all children, RTE cereal and breakfast consumption declined with age. Boys consumed RTE cereal more often compared with girls. Except for energy, RTE cereal consumption was positively associated with all measures of nutrients for both sexes. In boys, higher RTE cereal consumption was associated with lower total and low-density lipoprotein cholesterol levels and lower BMI. CONCLUSIONS: Food and nutrition professionals should continue to educate youth and their parents on the nutritional benefits of routinely eating RTE cereal.

What's love got to do with it? Family cohesion and healthy eating behaviors in adolescent girls.

OBJECTIVE: To examine the association between family cohesion and behaviors linked to health or overweight in adolescents. METHOD: Cross-sectional analyses of family cohesion and eating behaviors of 2,379 girls (followed from ages 9-19) who participated in the National Heart, Lung, and Blood Institute Growth and Health Study (NGHS). Height and weight measurements were obtained on an annual basis. Family cohesion was measured by the Family Adaptability and Cohesion Evaluation Scale (FACES) III. Food diaries were used to assess frequency of breakfast consumption and intake of milk, soda, fruits, and vegetables. RESULTS: Family cohesion was significantly associated with less soda intake and higher rates of breakfast consumption. Ingestion of milk, fruits, and vegetables was predicted by family cohesion at the trend level. CONCLUSION: Understanding the role of familial factors in adolescent eating behaviors is an important research priority. Strengthening family cohesion may be a valuable goal toward promoting the health of adolescents, increasing breakfast eating and decreasing soda consumption.

Longitudinal patterns of breakfast eating in black and white adolescent girls.

OBJECTIVE: The objective was to describe the pattern of breakfast eating over time ("breakfast history") and examine its associations with BMI and physical activity. RESEARCH METHODS AND PROCEDURES: This longitudinal investigation of patterns of breakfast eating included 1,210 black and 1,161 white girls who participated in the 10-year, longitudinal National Heart, Lung, and Blood Institute Growth and Health Study (NGHS). Three-day food records were collected during annual visits beginning at ages 9 or 10 up to age 19. Linear regression and path analysis were used to estimate the associations between breakfast history, BMI, and physical activity. RESULTS: Among girls with a high BMI at baseline, those who ate breakfast more often had lower BMI at the end of the study (age 19), compared with those who ate breakfast less often. Path analysis indicated that energy intake and physical activity mediated the association between patterns of breakfast eating over time and BMI in late adolescence. DISCUSSION: The association between regular breakfast consumption over time and moderation of body weight among girls who began the study with relatively high BMI suggests that programs to address overweight in children and adolescents should emphasize the importance of physical activity and eating breakfast consistently.

HIV prevention with jail and prison inmates: Maryland's Prevention Case Management program.

Prevalence of HIV infection and AIDS cases is higher among inmates of correctional facilities than among the general population, especially for female inmates. This creates a strong need for effective HIV prevention with this population. Maryland's Prevention Case Management (PCM) program provides individual or group counseling to inmates nearing release to promote changes in risk behavior. Pretest and posttest surveys assess changes in perceived risk, condom attitudes, condom use self-efficacy, self-efficacy to reduce injection drug risk and other substance use risk, and behavioral intentions during participation in the program. Client contact logs, kept by counselors, document the number and duration of sessions, and the specific modules, completed by participants. Over a 4-year period, PCM records identified 2,610 participants in the program. Pre-intervention and postintervention data were available for 745 participants, with client contact log records available for 529 (71%) of these individuals. Significant, positive changes were found in self-reported condom attitudes, self-efficacy for condom use, self-efficacy for injection drug use risk, self-efficacy for other substance use risk, and intentions to practice safer sex post-release. Inmate populations are a crucial audience for HIV/AIDS testing, treatment, and prevention efforts. The Maryland PCM program has documented positive changes in participants' attitudes, self-efficacy, and intentions related to HIV risk, over a 4-year period.

Child adjustment in joint-custody versus sole-custody arrangements: a meta-analytic review.

The author meta-analyzed studies comparing child adjustment in joint physical or joint legal custody with sole-custody settings, including comparisons with paternal custody and intact families where possible. Children in joint physical or legal custody were better adjusted than children in sole-custody settings, but no different from those in intact families. More positive adjustment of joint-custody children held for separate comparisons of general adjustment, family relationships, self-esteem, emotional and behavioral adjustment, and divorce-specific adjustment. Joint-custody parents reported less current and past conflict than did sole-custody parents, but this did not explain the better adjustment of joint-custody children. The results are consistent with the hypothesis that joint custody can be advantageous for children in some cases, possibly by facilitating ongoing positive involvement with both parents.