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Biomedical subjects

Howard Shapiro

Publications and source records attributed to Howard Shapiro.

17 recordsLinked to original sources
PubMed2005

Expectation of pregnancy outcome among mature women.

OBJECTIVE: Increasing numbers of mature women are achieving pregnancy largely through assisted reproductive technology (ART). Our objective was to investigate women over 45 years of age to determine the impact of pregnancy complications on newborn outcome. STUDY DESIGN: A study of women older than 45 years at their estimated date of confinement (EDC) was compared with a control group under 36 years at their EDC, matched by parity and plurality. All study patients and controls received uniform obstetric management through a single maternal fetal practice. The primary outcome was gestational age at birth stratified by plurality; secondary outcomes included birth weight, NICU days, composite neonatal morbidity, and a variety of obstetric complications. Wilcoxon signed rank and McNemar's tests were used as appropriate; logistic regression was used to calculate odds ratios (ORs) and CIs. Statistical significance was assumed for P < .05. RESULTS: Fifty study and control patients were identified over a 5-year period. Study patients were older than controls, but the difference in "gamete" age was not significant. There was significantly more assisted reproduction (donor egg) and preeclampsia among study patients. Importantly, gestational age at birth and birth weights stratified by plurality were not different (86% power to detect 2-week gestational age difference, alpha 0.05). Hospital days, NICU days, and composite neonatal morbidity were not different between study patients and controls. CONCLUSION: When controlled for parity and plurality, mature women over 45 years conceiving largely through ART with donor eggs can expect newborn outcomes similar to younger women cared for in the same setting of a high-risk maternal-fetal practice.

Adult↗
PubMed2004

Effects of Pd-bacteriopheophorbide (TOOKAD)-mediated photodynamic therapy on canine prostate pretreated with ionizing radiation.

The aim of this study was to evaluate the effects of photodynamic therapy (PDT) using a novel palladium bacteriopherophorbide photosensitizer TOOKAD (WST09) on canine prostate that had been pretreated with ionizing radiation. To produce a physiological and anatomical environment in canine prostate similar to that in patients for whom radiotherapy has failed, canine prostates (n = 4) were exposed to ionizing radiation (54 Gy) 5 to 6 months prior to interstitial TOOKAD-mediated PDT. Light irradiation (763 nm, 50-200 J/cm at 150 mW/cm from a 1-cm cylindrical diffusing fiber) was delivered during intravenous infusion of TOOKAD at 2 mg/kg over 10 min. Interstitial measurements of tissue oxygen profile (pO(2)) and of local light fluence rate were also measured. The prostates were harvested for histological examination 1 week after PDT. The baseline pO(2) of preirradiated prostate was in the range 10-44 mmHg. The changes in relative light fluence rate during PDT ranged from 12 to 43%. The acute lesions were characterized by hemorrhagic necrosis, clearly distinguishable from the radiotherapy-induced pre-existing fibrosis. The lesion size was correlated with light fluence and comparable to that in unirradiated prostate treated with a similar TOOKAD-PDT protocol. There was no noticeable damage to the urethra, bladder or adjacent colon. The preliminary results obtained from a small number of animals indicate that TOOKAD-PDT can effectively ablate prostate pretreated with ionizing radiation, and so it may provide an alternative modality for those prostate cancer patients for whom radiotherapy has failed.

Animals↗
PubMed2003

Echinacea and truth in labeling.

BACKGROUND: Echinacea sales represent 10% of the dietary supplement market in the United States, but there is no guarantee as to the content, quality, variability, or contamination in Echinacea preparations. OBJECTIVE: To qualitatively and quantitatively assess the contents of Echinacea-only preparations available in a retail setting. METHODS: One of each single-herb Echinacea preparations that were available in August 2000 was obtained from several stores in the Denver, Colo, area. Thin-layer chromatography (TLC) was used to determine species and measure quantity. From this information, accuracy of species labeling and comparison of constituent to labeled content were assessed. The samples were stratified by whether they were labeled as standardized, and the standardized and nonstandardized samples were compared by ratio of constituent to labeled content. RESULTS: Of the samples, 6 (10%) of 59 preparations contained no measurable Echinacea. The assayed species content was consistent with labeled content in 31 (52%) of the samples. Of the 21 standardized preparations, 9 (43%) met the quality standard described on the label. Labeled milligrams were weakly associated with measured constituent (r = 0.35; P =.02). CONCLUSIONS: Echinacea from retail stores often does not contain the labeled species. A claim of "standardization" does not mean the preparation is accurately labeled, nor does it indicate less variability in concentration of constituents of the herb.

Drug Labeling↗
PubMed2003

Laser-assisted penetration of topical anesthetic in adults.

OBJECTIVE: To determine whether pretreatment of skin with erbium:YAG (Er:YAG) laser-assisted delivery facilitates the penetration of lidocaine cream to provide anesthesia suitable for needlesticks after just 5 minutes. DESIGN: Trial 1 was a double-blind randomized controlled trial, whereas trial 2 was a nonblinded randomized controlled trial. SETTING: The study was conducted in 2 facilities, an academic and a private clinical research unit. PARTICIPANTS: A total of 320 healthy volunteers, aged 18 to 65 years and of any Fitzpatrick skin phototype. INTERVENTIONS: Trial 1 involved an Er:YAG laser pretreatment to disrupt the stratum corneum followed by an application of 4% lidocaine cream on one arm, and a laser pretreatment plus placebo on the other arm. Trial 2 involved an application of 4% lidocaine cream alone on one arm, and a laser pretreatment followed by an application of 4% lidocaine cream on the other arm. MAIN OUTCOME MEASURE: Self-reported pain perception on a 100-mm visual analog scale after quick insertion and removal of a 25-gauge hypodermic needle on the treatment sites. RESULTS: Data from the 2 trials showed that there was a 62% pain reduction with laser pretreatment plus lidocaine compared with laser pretreatment plus placebo, and a 61% pain reduction with laser pretreatment plus lidocaine, compared with lidocaine alone. The decrease in pain in both trials was statistically significant (P<.001). Adverse events reported 48 hours after treatment were few and mild. CONCLUSION: Treatment with the Er:YAG laser followed by lidocaine cream is a safe, effective, and efficient means of inducing skin anesthesia that significantly reduces the pain of hypodermic needle insertion.

Administration, Topical↗
PubMed2003

Low albumin level in the emergency department: a potential independent predictor of delayed mortality in blunt trauma.

Albumin is an abundant plasma protein with multiple physiologic functions, and low serum albumin levels have been associated with increased mortality in hospitalized patients. In a retrospective matched-pair study, we investigated whether emergency department (ED) albumin levels predict delayed mortality for patients initially stabilized after blunt trauma. Fifty-one hospital non-survivors who died more than 24 h after admission to a trauma center ED were matched by Injury Severity Score, type and location of injury, age, and gender with 51 survivors. All patients had serum albumin levels determined upon arrival in the ED. The non-survivors had a significantly lower admission albumin of 3.1 g/dL compared to 3.5 g/dL for survivors. Patients with albumin levels < 3.4 g/dL were 2.5 times more likely to die compared to patients with normal albumin levels. These preliminary results indicate that initial hypoalbuminemia in blunt trauma patients is an independent predictor of delayed mortality, suggesting that these patients require continued clinical vigilance and an aggressive search for evolving complications.

Adolescent↗
PubMed2003

Hyperoxygenation enhances the tumor cell killing of photofrin-mediated photodynamic therapy.

Tumor hypoxia, either preexisting or as a result of oxygen depletion during photodynamic therapy (PDT) light irradiation, can significantly reduce the effectiveness of PDT-induced cell killing. To overcome tumor hypoxia and improve tumor cell killing, we propose using supplemental hyperoxygenation during Photofrin-PDT. The mechanism for the tumor cure enhancement of the hyperoxygenation-PDT combination is investigated using an in vivo-in vitro technique. A hypoxic tumor model was established by implanting mammary adenocarcinoma in the hind legs of mice. Light irradiation (200 J/cm2 at either 75 or 150 mW/cm2), under various oxygen supplemental conditions (room air, carbogen, 100% normobaric or hyperbaric oxygen), was delivered to animals that received 12.5 mg/kg Photofrin 24 h before light irradiation. Tumors were harvested at various time points after PDT and grown in vitro for colony formation analysis. Treated tumors were also analyzed histologically. The results show that when PDT is combined with hyperoxygenation, the hypoxic condition could be improved and the cell killing rate at various time points after PDT could be significantly enhanced over that without hyperoxygenation, suggesting an enhanced direct and indirect cell killing associated with high-concentration oxygen breathing. This study further confirms our earlier observation that when a PDT treatment is combined with hyperoxygenation it can be more effective in controlling hypoxic tumors.

Adenocarcinoma↗
PubMed2002

Physicians want education about complementary and alternative medicine to enhance communication with their patients.

BACKGROUND: More than one third of patients in the United States use complementary and alternative medicine (CAM); most also visit conventional physicians. There is little information about how physicians and patients discuss CAM. We hypothesized that physicians frequently fielded questions about CAM treatments but felt uncomfortable discussing them owing to a lack of education. OBJECTIVES: To survey physicians to see how they discussed CAM with their patients and what factors influenced discussions and referrals. METHODS: A total of 751 physicians in the Denver, Colo, area were asked about their experience with CAM and communication about CAM with patients. Analyses were conducted using the SAS system (version 6, 1989; SAS Institute Inc, Cary, NC). RESULTS: Of the 705 deliverable surveys, 302 (43%) were returned: 76% of physicians reported having patients using CAM; 59% had been asked about specific CAM treatments; 48% had recommended CAM to a patient; and 24% had personally used CAM. Physician recommendation of CAM was most strongly associated with physician self-use (odds ratio, 6.98; P<.001). Few physicians felt comfortable discussing CAM with their patients, and the overwhelming majority (84%) thought they needed to learn more about CAM to adequately address patient concerns. CONCLUSIONS: Education about CAM modalities is a significant unmet need among Denver physicians, and education may help alleviate the discomfort physicians have when answering patients' questions about CAM. Physicians who use CAM treatments themselves are much more likely to recommend CAM for their patients than physicians who do not.

Adult↗
PubMed2002

Precise CD4 T-cell counting using red diode laser excitation: for richer, for poorer.

BACKGROUND: Measuring CD4 T-cell counts at low cost is relevant in dealing with the human immunodeficiency virus (HIV) epidemic throughout the developing world. The recently introduced novel concepts in gating strategies and sample stabilization facilitate affordable immunophenotyping by flow cytometry. However, the impact of these developments is still limited by the high cost of currently available flow cytometers. METHODS: Diode lasers emitting 10-15 mW at 635 nm are one-tenth the size and cost and require one thousandth the power of an equivalent 488-nm argon ion laser. We used the available 635-nm diode-based flow cytometers, including PA-II, Luminex 100, SuperMot, and FACSCalibur, to investigate whether these instruments can generate reliable CD4 counts when used with allophycocyanin (APC) and cyanin-5 (Cy5)-labeled CD4 antibodies. RESULTS: We document the feasibility of obtaining leucocyte differential counts using orthogonal side scatter (SSC) without the need for forward scatter (FSC). Accurate CD4% values among lymphocytes and leucocytes can be obtained by primary CD4 gating using a single CD4 monoclonal antibody conjugated to APC or Cy5. Double immunofluorescence (IF) staining with CD4-APC (FL1) and CD45-APC-Cy7 (FL2) introduces pan-leucogating for a convenient assessment of absolute CD4 counts on double platforms. We demonstrate that small flow cytometers with laser diodes are capable of delivering absolute CD4 T-cell counts with a precision similar to the performance of the current state-of-the-art single-platform instruments (e.g., the CytoronAbsolute; R(2) = 0.961). In this respect, they appear to be superior to the nonflow CD4 counting techniques. CONCLUSIONS: Accurate CD4 counts can be generated at minimal cost on red diode laser-operated flow cytometers, retaining the potential for high throughput capacity without compromising precision. With further improvements in volumetric technology and clinical software, these cytometers may develop into a new generation of inexpensive battery-operated laboratory hardware that combines cellular phenotyping with bead-based multiplexing immunoassays for (HIV) serology.

CD4 Antigens↗
PubMed2002

Laser assisted delivery of topical anesthesia for intramuscular needle insertion in adults.

BACKGROUND AND OBJECTIVES: Currently there is no safe, effective, and rapid means to eliminate the pain associated with a needle insertion through the skin. It is hypothesized that ablation of the stratum corneum layer using a low energy Erbium(Er):YAG laser would allow rapid local anesthesia from a lidocaine product. STUDY DESIGN/MATERIALS AND METHODS: Eighty volunteers participated in a placebo-controlled, double blind, cross-over study employing the Norwood-Abbey (Chelsea Heights, Victoria, Australia) laser anesthesia device (LAD) and two lidocaine preparations. Upper-arm skin ablation was followed by a 5-minute application of study treatment. Pain scores were registered immediately following a needle insertion. RESULTS: Comparing the combined lidocaine preparations to placebo, there was a statistically significant reduction in pain when the LAD was employed (P < 0.001). The median pain reduction for lidocaine was 51.3% (95% CI = [40.9, 76.1]). CONCLUSIONS: Use of the low energy Er:YAG LAD device in combination with a 5-minute application of lidocaine significantly reduced the pain associated with a needle insertion.

Adult↗
PubMed2002

Seniors' preferences for cancer screening and medication use based on absolute risk reduction.

BACKGROUND: This study was conducted to determine the influence of patient perceptions of absolute risk on choices for cancer screening and use of medications to prevent heart attack, stroke, and hip fracture. METHODS: At the end of routine office visits, we surveyed all eligible consecutive patients who visited four geriatricians in a Denver practice between November 8, 1993, and February 9, 1994. RESULTS: We saw a total of 675 outpatients during the study period and completed the interview with 409 patients (75% female, mean age 81, 78% Caucasian). We found a strong correlation between (i) increased probability of detecting cancer and greater preference for cancer screening tests (p <.001) and (ii) increased probability of preventing disease (heart attack, stroke, or hip fracture) and greater preference for preventive medication (p <.0001). There was notable variability in seniors' preferences for a given therapy at each absolute risk threshold. For example, 15% of seniors did not think that highly effective, inexpensive medications to prevent heart attacks were worthwhile for them. At the other end of the spectrum, 22% of seniors felt that low-yield, costly medications to prevent heart attacks were worthwhile. CONCLUSIONS: Seniors readily understand the probability of benefit expressed in terms of absolute risk reduction. Furthermore, probability of benefit strongly influences seniors' preferences for cancer screening and preventive medication use. Finally, there is variety in the thresholds of prevention at which individuals are willing to accept preventive treatment. The probability of benefit is an essential and useful element for seniors to make informed decisions about routine health services.

Age Factors↗
PubMed2002

Why do some women refuse to allow male residents to perform pelvic exams?

PURPOSE: Many women who receive medical care in residency training clinics refuse to allow male residents to perform their pelvic exams. This study was conducted to identify which women were most likely to refuse and to learn their reasons for refusing. METHOD: From January to March 1997, a questionnaire was given to all women entering a Tri-County Health office and a Planned Parenthood clinic, both in the Denver, Colorado, metropolitan area, who consented to participate in the study. Data from the questionnaire were analyzed using a statistical software package. RESULTS: A total of 1,437 women entered the clinics during the study period. Of these patients, 1,078 consented to complete the questionnaire. Seven of these 1,078 women did not complete the questionnaire. Women who did not know the training level of the resident performing the pelvic exam were more likely to refuse than were women who knew the training level of the resident (p =.001), but many women preferred a female physician regardless of the physician's training level. Fifty-eight percent said they would allow a male resident to observe a female attending physician perform the exam, compared with 36% who said they would allow a male resident to observe if the attending physician was a man. Common statements from those who would refuse were: "I am just more comfortable with a female," "Women do not want men to examine their private body parts," and "Women explain things better." CONCLUSIONS: A woman's knowledge of the resident's training level correlates with her willingness to have a pelvic exam performed by a male resident. Women who said they would refuse a pelvic exam performed by a male resident gave specific reasons for their decision.

Adult↗
PubMed2002

Improvement of tumor response by manipulation of tumor oxygenation during photodynamic therapy.

Photodynamic therapy (PDT) requires molecular oxygen during light irradiation to generate reactive oxygen species. Tumor hypoxia, either preexisting or induced by PDT, can severely hamper the effectiveness of PDT. Lowering the light irradiation dose rate or fractionating a light dose may improve cell kill of PDT-induced hypoxic cells but will have no effect on preexisting hypoxic cells. In this study hyperoxygenation technique was used during PDT to overcome hypoxia. C3H mice with transplanted mammary carcinoma tumors were injected with 12.5 mg/kg Photofrin and irradiated with 630 nm laser light 24 h later. Tumor oxygenation was manipulated by subjecting the animals to 3 atp (atmospheric pressure) hyperbaric oxygen or normobaric oxygen during PDT light irradiation. The results show a significant improvement in tumor response when PDT was delivered during hyperoxygenation. With hyperoxygenation up to 80% of treated tumors showed no regrowth after 60 days. In comparison, when animals breathed room air, only 20% of treated tumors did not regrow. To explore the effect of hyperoxygenation on tumor oxygenation, tumor partial oxygen pressure was measured with microelectrodes positioned in preexisting hypoxic regions before and during the PDT. The results show that hyperoxygenation may oxygenate preexisting hypoxic cells and compensate for oxygen depletion induced by PDT light irradiation. In conclusion, hyperoxygenation may provide effective ways to improve PDT efficiency by oxygenating both preexisting and treatment-induced cell hypoxia.

Animals↗
PubMed2002

Performance of a new screening spirometer at a community health fair.

OBJECTIVE: Compare the results from a new screening spirometer (EasyOne) with the results from a standard laboratory spirometer (Vmax) approved by the American Thoracic Society. SETTING: A health fair at a community hospital. METHODS: We measured forced expiratory volume in the first second (FEV(1)) and forced expiratory volume in the first 6 seconds (FEV(6)). With the screening spirometer, good quality testing was achieved in 359 of 394 subjects (91%), and 115 subjects were also tested with the standard laboratory spirometer. The best test values for FEV(1) and FEV(6) were taken for 3 tests that agreed within 3%. FEV(6) was extrapolated from forced vital capacity on the printouts from the standard laboratory spirometer. RESULTS: Correlations between the screening spirometer results and the standard laboratory spirometer were excellent for FEV(1) (r = 0.93), FEV(6) (r = 0.96), and FEV(1)/FEV(6) (r = 0.72) (p = 0.001 for all comparisons). The 95% limits of agreement (mean difference between the 2 spirometers +/- 1.96 standard deviations) were: -0.18 and 0.69 for FEV(1); -0.24 and 0.81 for FEV(6); and -0.12 and 0.13 for FEV(1)/FEV(6). CONCLUSION: The new screening spirometer is suitable for clinical use.

Adult↗
PubMedDate not supplied

Lumpectomy and breast radiotherapy in breast cancer patients with a family history of breast cancer, ovarian cancer, or both.

This article presents an outcomes review of breast cancer patients identified from the cancer registries of four area hospitals. These patients had family histories of breast cancer, ovarian carcinoma, or both and were treated with conservative surgery and radiation to the involved breast. Patients were as follows: group 1, one first-degree relative ( n = 165, one synchronous bilateral breast cancer); group 2, > or =2 first-degree relatives ( n = 21); group 3, one second-degree relative ( n = 20); and group 4, > or =2 second-degree relatives ( n = 18). The total of patients and breast cancer events was 224 and 225, respectively. Group 5 was a subgroup of 53 patients with a substantial risk (>10%) of a BRCA1 or BRCA2 mutation. After a median follow-up of 3.9 years, 5 patients had local failure (2%), and 5 developed a contralateral breast cancer (2%). There were no significant differences in local failure rates between groups (p = 1.0): group 1, 5 of 166 (3%); group 2, 0 of 21 (0%); group 3, 0 of 20 (0%); and group 4, 0 of 18 (0%). Local failure for group 5 was 2% (1 of 53). Four of 143 patients (3%) with a minimum 3 years of follow-up (median, 5.6 years) had local failure, and 5 (4%) developed a contralateral breast cancer. A univariate analysis was statistically significant for differentiation only (well, 0 of 67; moderately, 1 of 57 [1.8%]; poor, 3 of 26 [11.5%], p = 0.008). Overall survival for groups 1-4 did not differ significantly. Although follow-up has been relatively short, we have not found that breast cancer patients with various degrees of family histories of breast/ovarian carcinoma have had a detrimental outcome when treated with conservative therapy.

Analysis of Variance↗
PubMedDate not supplied

Excision only for tubular carcinoma of the breast.

The purpose of this study was to assess the rationale of excision only (without breast irradiation) in patients with small (< or =3 cm) tubular/well-differentiated breast cancers. A total of 44 patients with pure tubular invasive breast cancer who have undergone complete excision only and have had a minimum 1-year follow-up were identified from the Colorado Cancer Registry and assessed for recurrence rates as well as median local disease-free and overall survival. Treatment dates were October 1972 to April 2001. The median age was 67 years (range 40-96 years). The median tumor size was 6.5 mm (range 2-30 mm). All patients had a complete excision with negative margins. Staging was as follows: T1N0 (11), T1Nx (27), T2N0 (1), T1N1 (3); 2 were unable to be staged accurately. After a median follow-up of 5.4 years (range 1.1-26.3 years) there were only two local recurrences in the ipsilateral breast (at 7.6 and 8.8 years), for a crude local control rate of 96% (2/44). Both patients were salvaged, are alive, and currently have no evidence of disease (NED) at last follow-up of 9 and 13.3 years. Actuarial 5- and 10-year local control rates were 100% and 87%. Actuarial 5- and 10-year overall and disease-free survivals were 80% and 52%, and 100% and 91%. Twenty-five patients had more than 5 years of follow-up. The median follow-up for this group was 9.1 years (range 5.1-26.3 years) and both recurrences were in this group. Although the number of cases in this report is small, it represents the largest total and longest follow-up for tubular breast cancer cases after excision alone. This report suggests that breast irradiation could be omitted after conservative surgery in older patients with smaller (< or =3 cm) tubular/well-differentiated breast cancers. However, due to the retrospective nature of our report, we cannot categorically make this recommendation.

Adenocarcinoma↗