Overview and quality assurance for the National Health and Nutrition Examination Survey (NHANES) oral health component, 1999-2002.

The Oral Health Component of the 1999-2002 National Health and Nutrition Examination Survey (NHANES) is a collaborative effort between the National Institute of Dental and Craniofacial Research (NIDCR), the National Center for Chronic Disease Prevention and Health Promotion, Division of Oral Health (NCCDPHP/DOH), and the National Center for Health Statistics (NCHS). The current NHANES is designed as a continuous survey with data released on a 2-year cycle to represent the civilian, non-institutionalized population of the US. Oral health data are currently available for 8082 and 9010 persons aged > or =2 years who participated in the 1999-2000 and 2001-2002 NHANES, respectively. This article provides background information on previous national examination surveys with oral health content. It also provides general analytical considerations, oral health content information, and evaluations of data quality in terms of examiner reliability statistics (percent agreements, kappa, and correlation coefficients) for the 1999-2002 NHANES Oral Health Component.

Tables for the selection of correct blood pressure cuff size based on self-reported height and weight and estimating equations for mid-arm circumference: data from the US National Health and Nutrition Examination Survey.

The purpose of this study was to develop practical prediction equations for estimating adult mid-arm circumference (AC) using self-reported height and weight data from NHANES III 1988-1994 and NHANES 1999-2000. Both surveys used a complex sample design to obtain nationally representative data for the US civilian noninstitutionalized population. The analytic sample consisted of 4801 men and 4854 women in NHANES III and 1960 men and 2180 women from NHANES 1999-2000. Self-reported weight, height, and age data from NHANES III were used for model building, and similar data from NHANES 1999-2000 were used for validation. An all-possible regressions procedure by gender was used to derive the mid-AC prediction equations. The final prediction equations for adult mid-AC are (for self-reported weight in pounds and height in inches) for men: AC (cm) = 32.52145 + 0.10975 x (wt)-0.26057 x (ht)-0.03028 x (age), R2 = 0.76; and for women: AC (cm) = 30.22126 + 0.13534 x (wt)-0.34121 x (ht) + 0.09014 x (age)-0.00082565 x (age2), R2 = 0.81. Based on these equations, tables were created to predict mid-AC using self-reported height and weight. Clinicians can refer to our prediction equations and reference tables to determine mid-AC and proper BP cuff sizes.

High-dose carboplatin with diethyldithiocarbamate chemoprotection in treatment of women with relapsed ovarian cancer.

Diethyldithiocarbamate (DDTC) has been found to protect the bone marrow, kidneys, and gastrointestinal tract from the toxic effects of cisplatin and carboplatin (CBDCA) in animal models. In an attempt to minimize the toxic effects of high-dose CBDCA (800 mg/m2), a pilot study was undertaken in which women with relapsed or refractory epithelial ovarian cancer were treated with high-dose CBDCA, which was followed 3 hours later with DDTC (4 g/m2). There were four partial responses and no complete response in 21 patients who could be evaluated (overall response rate, 19%). Significant toxic effects, including three treatment-related deaths, were associated with the regimen. This study suggests that while high-dose CBDCA plus DDTC may be active in relapsed or refractory ovarian cancer, it is associated with clinically significant hematologic and autonomic toxic effects.

Evaluation of platinum-DNA adduct levels relative to known prognostic variables in a cohort of ovarian cancer patients.

Single-agent chemotherapy with cisplatin or carboplatin can induce remissions in approximately 30% of previously treated patients with advanced stage ovarian cancer. Previous studies have shown that the extent of platinum-DNA adduct formation measured in WBC DNA of ovarian cancer patients treated with cisplatin or carboplatin is directly associated with disease response (Reed et al., Proc. Natl. Acad. Sci. USA, 84: 5024-5028, 1987). It has been unclear whether adduct level in WBC DNA is independent of known prognostic variables in this disease, or whether adduct level parallels a known prognostic variable that can be more easily monitored. In a cohort of 24 ovarian cancer patients treated with single-agent cisplatin or carboplatin, we retrospectively assessed the relationship between disease response, platinum-DNA adducts in WBC DNA, and each of eight prognostic variables by both univariate analysis and multivariate analysis. The prognostic variables evaluated included: response to previous treatment, Karnofsky status, total platinum dose prior to current therapy, stage of disease, age, bulk of disease at initiation of therapy, histological type, and histological grade. By univariate analysis, adduct level was strongly associated with disease response (two-sided P = 0.0058), with the next strongest associations with disease response being held by Karnofsky status (P = 0.125), stage of disease (P = 0.189), response to previous treatment (P = 0.352), total previous platinum dose (P = 0.358), and age (P = 0.374). No significant associations were found between adduct level and histological type or histological grade. Further, when patients were stratified by the number of cycles studied (one cycle, two cycles, or three cycles), higher levels of adduct were consistently seen in those patients responding to therapy. We conclude that, in this small cohort of refractory ovarian cancer patients treated with single-agent cisplatin or carboplatin, adduct level in WBC DNA appears to be more closely related to disease response than other previously identified prognostic variables.

High-dose cisplatin in hypertonic saline in refractory ovarian cancer.

Nineteen previously treated refractory ovarian cancer patients, including 17 who had received standard-dose cisplatin regimens, were treated in a phase II trial with high-dose cisplatin (40 mg/m2 daily for five days with cycles administered every 28 to 35 days). Objective responses were achieved in 6/19 (32%) patients while eight patients had minor responses or stable disease. The median duration of survival from the start of salvage chemotherapy was 12 months for all patients, and 16 months for responding patients. The dose-limiting toxicity was peripheral neuropathy with 37% of patients having severe paresthesias or ataxia. These results indicate that the dose of cisplatin may be an important factor in improving survival in ovarian cancer patients.

High-dose carboplatin in refractory ovarian cancer patients.

Thirty previously treated refractory ovarian cancer patients, all of whom received prior therapy with cisplatin, were treated in a phase II trial with high-dose carboplatin (800 mg/m2 per cycle with cycles administered every 35 days). Patients were treated with high-dose carboplatin when they were no longer responding to prior therapy or had relapsed after an initial response. Objective responses were achieved in eight of 30 patients (27%) while ten patients had minor responses or stable disease. No responses were observed from high-dose carboplatin in patients who had progressive disease during prior therapy with a cisplatin-based regimen. The primary toxicity of high-dose carboplatin was myelosuppression with a median WBC nadir of 0.6 and a median platelet nadir of 6,500 after the first cycle of therapy. Myelosuppression was not particularly cumulative as 78% of patients were able to receive either 100% or 75% of the projected dose even with the fourth cycle of high-dose carboplatin. The gastrointestinal (GI) toxicity of carboplatin was mild and there was no clinically apparent nephrotoxicity or neurotoxicity. These results demonstrate that: there is marked cross-resistance between cisplatin and carboplatin, and high-dose carboplatin may be a potential alternative to high-dose cisplatin in the treatment of ovarian cancer patients.

A randomized trial of standard chemotherapy v a high-dose chemotherapy regimen in the treatment of poor prognosis nonseminomatous germ-cell tumors.

We performed a prospective randomized trial of a high-dose chemotherapy regimen v standard cisplatin-based chemotherapy in poor prognosis nonseminomatous germ-cell cancer patients. The high-dose regimen consisting of twice the standard dose of cisplatin (P), along with vinblastine (Ve), bleomycin (B), and the epipodophylotoxin etoposide (VP-16) (V) (PVeBV) was compared to the classic regimen with normal dose cisplatin, vinblastine, and bleomycin (PVeB). Eligibility criteria included large abdominal masses, liver metastases, multiple pulmonary metastases, brain metastases, marked elevations in serum tumor markers (alpha-fetoprotein greater than 1,000 ng/mL or the beta-subunit of human chorionic gonadotropin greater than 10,000 mIU), unfavorable histology (pure choriocarcinoma), or extragonadal germ-cell tumors. Fifty-two consecutive patients with poor prognostic features were randomized to receive either PVeBV or PVeB. The median follow-up is 4 years. Treatment with the high-dose regimen increased the complete remission rate (88% v 67%, P = .14) and was associated with a lower relapse rate (17% v 41%, P = .2). The median survival of patients receiving standard therapy was 30 months, while the median survival for patients receiving the high-dose regimen has not been reached. Actuarial 5-year survival for patients treated with the high-dose regimen is 78%, compared with 48% for patients receiving standard therapy (two-sided Mantel-Cox test = .06). Disease-free survival was also superior for patients randomized to PVeBV (P = .03). Sixty-eight percent of patients (23 of 34) randomized to PVeBV are alive and continuously disease-free, compared with 33% (six of 18) for PVeB (P = .02). The major difference in toxicity between the high-dose regimen and standard therapy was the severity of myelosuppression and the incidence of severe hearing loss. Ninety-one percent of patients treated with PVeBV had a WBC count less than 1,000/microL, compared with 50% of patients receiving PVeB (P less than .05). Hearing aids were recommended for 12 patients who received PVeBV and two who received PVeB. The increased effectiveness of the PVeBV regimen in poor prognosis germ-cell cancer patients may relate to the double-dose cisplatin, the addition of VP-16, or to a synergistic effect of these two drugs.

Long-term results of a cisplatin-containing combination chemotherapy regimen for the treatment of advanced ovarian carcinoma.

Sixty-two patients with advanced ovarian adenocarcinoma (stages III and IV) and without prior chemotherapy or radiotherapy were treated with a four-drug combination consisting of cyclophosphamide, hexamethylmelamine, 5-fluorouracil (5-FU), and cisplatin (Chex-UP). All patients were evaluable for toxicity and response, and survivors have been observed for a minimum of 48 months. The overall response rate to Chex-UP chemotherapy was 69%, with 12 patients (19%) achieving a pathologically confirmed complete remission (CR) as documented by a negative second-look laparotomy. Seven of the twelve patients (58%) who achieved a surgically confirmed CR were randomized to six cycles of intraperitoneal (IP) 5-FU. There have been seven relapses in patients who had a negative second-look laparotomy, but only four of the patients died from recurrent ovarian cancer. The median duration of remission following a negative second-look laparotomy was 53 months, while the median duration of survival has not been reached and will exceed 7.5 years. Seventeen patients (27%) achieved a clinical CR with chemotherapy but were found to have residual disease at second-look laparotomy. The median survival for these patients was 29 months, which was statistically inferior to that achieved for those patients with a negative second-look laparotomy (P less than .002), and only one patient is alive after 4 years. All patients who either achieved a partial response (PR) to therapy (14 of 62; 23%) or did not respond to therapy (19 of 62; 31%) died of ovarian cancer by 24 months. Thus, prolonged survival is associated with a surgically confirmed CR to induction therapy with Chex-UP. However, only a minority of advanced-stage ovarian cancer patients (15%) are alive 4 years after initiation of treatment with this regimen.

Retinal toxicity after high-dose cisplatin therapy.

Because of increasing complaints of visual dysfunction, 13 patients with refractory or recently diagnosed ovarian carcinoma were evaluated for possible cisplatin-induced ophthalmologic toxicity. All patients had received high-dose cisplatin (200 mg/m2 in five divided daily doses) over two to four cycles. Eight patients (62%) developed symptoms of blurred vision and three (23%) also developed altered color perception. Retinal toxicity in the form of cone dysfunction was documented by electroretinography and color vision testing in 11 patients. Three patients were studied prospectively. Two patients who developed cone dysfunction had normal ophthalmologic exams before the initiation of chemotherapy or after one cycle of cisplatin, suggesting a causal relationship between cisplatin therapy and subsequent retinal abnormalities. Though visual acuity improved off therapy, color vision abnormalities persisted as long as 16 months beyond therapy.

Verapamil and adriamycin in the treatment of drug-resistant ovarian cancer patients.

Eight patients with refractory ovarian cancer were treated on a pilot protocol of verapamil plus Adriamycin (Adria Laboratories, Columbus, OH). This trial was based on our previous laboratory studies which demonstrated that Adriamycin resistance in human ovarian cancer cell lines could be partially reversed by exposure of the cells to high concentrations of verapamil (3,000 ng/mL). Patients were treated in an intensive care unit with continuous cardiovascular monitoring. The dose of verapamil was escalated in each patient until hypotension or heart block developed, and this dose was maintained for 72 hours. Adriamycin (50 mg/m2) was infused over 24 hours during the second day of the verapamil infusion and verapamil alone was administered on the third day in an effort to block efflux from drug-resistant cells. This intensive approach led to a median plasma verapamil level of 1,273 ng/mL (range, 720 to 2,767). However, the high infusion rates of verapamil (9 micrograms/kg/min) required to achieve these plasma levels produced an unacceptable degree of cardiac toxicity. Two patients developed transient atropine-responsive complete heart block and four patients developed transient congestive heart failure with increases in pulmonary capillary wedge pressure. There was no evidence that the noncardiac toxicities of Adriamycin were enhanced by verapamil. There were no objective responses to therapy. Future studies should use less cardiotoxic calcium channel blockers that can be safely administered to produce the plasma levels required for in vitro sensitization of drug resistant cells.

US demographic trends in mid-arm circumference and recommended blood pressure cuffs: 1988-2002.

Mid-arm circumference (AC) measurement is a prerequisite for the selection of properly sized blood pressure (BP) cuffs and accurate BP readings. This study examined trends in the frequency distribution of mid-AC and corresponding recommended BP cuff sizes using National Health and Nutrition Examination Survey (NHANES) III (1988-1994) and NHANES 1999-2002 data. Both surveys used a complex sample design to obtain nationally representative samples of the civilian noninstitutionalized US population. The sample consisted of 7453 men and 8372 women from NHANES III and 4295 men and 4838 women from NHANES 1999-2002. Mean mid-AC (cm) and associated American Heart Association-defined cuff sizes were assessed. Variables were analysed by gender, age, race/ethnicity, and by hypertension or diabetic co-morbidity. Mid-AC increased significantly between surveys for all age groups; the greatest increase in mid-AC occurred in the 20-39 year age group. Data from NHANES 1992-2002 show that among nonHispanic white and nonHispanic black men aged 20-59 years, the mean mid-AC was >34 cm. Among NHB women aged 40 years and above, the mean mid-AC was greater than or equal to 34 cm. In all, 42% of all men and 26% of all women aged 40-59 years required large BP cuffs. In all, 39% of individuals classified as hypertensive and 47% of self-reported diabetics required a BP cuff greater than the standard adult size. In conclusion, mean mid-AC has increased across many demographic subgroups in the US with implications for the accuracy of BP measurement in clinical practice.

High dose cisplatin and high dose carboplatin in refractory ovarian cancer.

High dose cisplatin (40 mg/m2 qd x 5) and high dose carboplatin (400 mg/m2 qd x 2) were administered to advanced ovarian cancer patients who were refractory to standard therapy which included standard dose cisplatin regimens. Cisplatin was administered in 250 ml of 3% saline with 61 per day of saline hydration while carboplatin was administered in 500 ml D5W by continuous infusion for 48 hours. Objective responses were observed in 6/19 (32%) patients treated with high dose cisplatin and an additional 8 patients (42%) had minor responses or stable disease. The preliminary response rate in an ongoing phase II trial of high dose CBDCA is 33% (4/12 patients). There have been no responses to high dose CBDCA in patients who were resistant to high dose cisplatin. The dose limiting toxicity of high dose cisplatin is a peripheral neuropathy while high dose carboplatin results in severe, but reversible, myelosuppression. High dose carboplatin was less emetogenic than cisplatin and did not produce renal toxicity or peripheral neuropathy. In addition, in vitro cytotoxicity studies in cisplatin sensitive and resistant human ovarian cancer cell lines demonstrated a steep dose response relationship with both cisplatin and carboplatin and extensive cross resistance between these two platinum analogs. Studies are currently in progress to determine the efficacy and toxicity of high dose cisplatin or high dose carboplatin combined with alkylating agents in previously untreated advanced ovarian cancer patients.

Effects of cancer and its treatments on plasma concentration of alpha 1-acid glycoprotein and propranolol binding.

The plasma concentrations of alpha 1-acid glycoprotein (AAG) and albumin, and the plasma protein binding of propranolol were measured in a group of cancer patients and a group of normal subjects. In cancer patients the AAG concentrations were twice that in controls (142 and 78 mg/dl, P less than 0.005), the albumin concentrations were lower (3.11 and 4.37 gm/dl, P less than 0.001), and the free fraction of propranolol was lower (0.127 and 0.190, P less than 0.005). Propranolol binding correlated strongly with AAG concentrations. These data imply that untreated or unsuccessfully treated cancer patients will have reduced free fractions for any drug for which AAG is an important binding protein. Successfully treated patients may have longitudinal changes towards normal. No consistent effect of the treatments themselves on AAG was observed after radiation therapy in five patients or after intravenous adriamycin in six patients.

The prevalence of functional limitations and disability in older persons in the US: data from the National Health and Nutrition Examination Survey III.

OBJECTIVE: To provide estimates by sex and age and by sex and race/ethnicity of the proportion of older Americans who have difficulty with functional limitations and daily activities. SETTING: The Third National Health and Nutrition Examination Survey (NHANES III) 1988-1994. DESIGN: A cross-sectional nationally representative survey. PARTICIPANTS: All persons aged 60 and older who completed a household interview (N = 6,866) during NHANES III (conducted 1988-1994). MEASUREMENTS: The self-reported physical and functional disability questions from NHANES III included: lower-extremity function, instrumental activities of daily living, basic activities of daily living, needing help with personal and routine daily activities, and use of assistive devices for walking. RESULTS: Non-Hispanic black and Mexican-American men and women generally reported significantly (P < .01) more disability than did non-Hispanic white men and women. Disability was greater for minority women than for men. For both men and women, the prevalence in disability increased significantly (P < .01) with age for each measure. CONCLUSIONS: These sex-age and sex-race/ethnicity national estimates of disability indicate that minority women may represent a vulnerable subpopulation.

Reliability and prevalence of physical performance examination assessing mobility and balance in older persons in the US: data from the Third National Health and Nutrition Examination Survey.

OBJECTIVE: This report provides reliability and prevalence estimates by sex, age, and race/ethnicity of an observed physical performance examination (PPE) assessing mobility and balance. SETTING: The Third National Health and Nutrition Examination Survey (NHANES III) 1988-1994. DESIGN: A cross-sectional nationally representative survey. PARTICIPANTS: All persons aged 60 and older (n = 5,403) who performed the PPE either in the mobile examination center (MEC) or in the home during NHANES III (conducted 1988-1994). MEASUREMENTS: The PPE included timed chair stand, full tandem stand, and timed 8-foot walk. RESULTS: Timed chair stand and 8-foot timed walk were reliable measurements (Intraclass Correlations > 0.5). Women were significantly slower (P < .001) than men for both timed chair stands and timed walk. Non-Hispanic white men and women did the maneuvers in significantly less time than non-Hispanic black men and women and Mexican Americans women (P < .001). CONCLUSIONS: Lower extremity functions measured by timed chair stand and walk are reliable. Women at every age group were more physically limited than men.

Self-assessed learning needs of oncology nurses caring for individuals with HIV-related disorders. A national survey.

A national survey of 10% of the members of the Oncology Nursing Society (ONS) was conducted to determine the knowledge and experience of oncology nurses caring for individuals with HIV-related disorders. This information was to serve as the framework for developing subsequent education and preparation of oncology nurses. A questionnaire containing 109 questions was mailed to 1,006 members of the ONS. Response rate was 70% (N = 693). Fifty-five of the 109 questions assessed clinical knowledge, experience, and care planning for adults. Additional questions elicited information about staff attitudes, problems in care delivery, priorities in nursing administration and research, and nurses' preferred methods of instruction. Results showed that oncology nurses are experienced in certain areas of importance to patients with AIDS but have educational and experiential deficits in the disease specifics associated with HIV-related disorders and in the nursing care of adults with multisystem involvement and in their treatment. Validity and reliability of this questionnaire were established (alpha = 0.93-0.97). Readers are encouraged to adapt this questionnaire to assess the learning needs of nurses in all specialty groups, and to develop appropriate educational programs to prepare nurses to provide care for this patient population.