Takamaru Ashikaga

University of Vermont, Burlington, Vermont, United States

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Publications (71)388.33 Total impact

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    ABSTRACT: Simulation-based training has been associated with reduced central line-associated bloodstream infection (CLABSI) rates. We measured the combined effect of simulation training, electronic medical records (EMR)-based documentation, and standardized kits on CLABSI rates in our medical (MICU) and surgical (SICU) intensive care units (ICU).
    American journal of infection control. 06/2014; 42(6):643-8.
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    ABSTRACT: BACKGROUND: The impact of arm morbidity following breast cancer surgery on patient-observed changes in daily functioning and health-related quality of life (HRQoL) has not been well-studied. OBJECTIVE: To examine the association of objective measures such as range of motion (ROM) and lymphedema, with patient-reported outcomes (PROs) in the arm and breast, upper extremity function, activities, and HRQoL. METHODS: The National Surgical Adjuvant Breast and Bowel Project Protocol B-32 was a randomized trial comparing sentinel node resection (SNR) with axillary dissection (AD) in women with node-negative breast cancer. ROM and arm volume were measured objectively. PROs included symptoms; arm function; limitations in social, recreational, occupational, and other regular activities; and a global index of HRQoL. Statistical methods included cross-tabulations and multivariable linear regression models. RESULTS: In all, 744 women provided at least 1 postsurgery assessment. About one-third of the patients experienced arm mobility restrictions. A similar number of patients avoided the use of the arm 6 months after surgery. Limitations in work and other regular activities were reported by about a quarter of the patients. In this multivariable analysis, arm mobility and sensory neuropathy were predictors of patient-reported arm function and overall HRQoL. Predictors for activity limitations also included side of surgery (dominant vs nondominant). Edema was not significant after adjustment for sensory neuropathy and ROM. LIMITATIONS: Arm mobility and edema were measured simultaneously only once during the follow-up (6 months). CONCLUSION: Clinical measures of sensory neuropathy and restrictions in arm mobility following breast cancer surgery are associated with self-reported limitations in activity and reductions in overall HRQoL.
    The journal of supportive oncology 08/2012;
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    ABSTRACT: Retrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or survival among patients with breast cancer. Prospective data on clinical outcomes from randomized trials according to sentinel-node involvement have been lacking. We randomly assigned women with breast cancer to sentinel-lymph-node biopsy plus axillary dissection or sentinel-lymph-node biopsy alone. Paraffin-embedded tissue blocks of sentinel lymph nodes obtained from patients with pathologically negative sentinel lymph nodes were centrally evaluated for occult metastases deeper in the blocks. Both routine staining and immunohistochemical staining for cytokeratin were used at two widely spaced additional tissue levels. Treating physicians were unaware of the findings, which were not used for clinical treatment decisions. The initial evaluation at participating sites was designed to detect all macrometastases larger than 2 mm in the greatest dimension. Occult metastases were detected in 15.9% (95% confidence interval [CI], 14.7 to 17.1) of 3887 patients. Log-rank tests indicated a significant difference between patients in whom occult metastases were detected and those in whom no occult metastases were detected with respect to overall survival (P=0.03), disease-free survival (P=0.02), and distant-disease-free interval (P=0.04). The corresponding adjusted hazard ratios for death, any outcome event, and distant disease were 1.40 (95% CI, 1.05 to 1.86), 1.31 (95% CI, 1.07 to 1.60), and 1.30 (95% CI, 1.02 to 1.66), respectively. Five-year Kaplan-Meier estimates of overall survival among patients in whom occult metastases were detected and those without detectable metastases were 94.6% and 95.8%, respectively. Occult metastases were an independent prognostic variable in patients with sentinel nodes that were negative on initial examination; however, the magnitude of the difference in outcome at 5 years was small (1.2 percentage points). These data do not indicate a clinical benefit of additional evaluation, including immunohistochemical analysis, of initially negative sentinel nodes in patients with breast cancer. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003830.).
    New England Journal of Medicine 02/2011; 364(5):412-21. · 51.66 Impact Factor
  • Marie E Wood, Teresa A Fama, Takamaru Ashikaga, Hyman B Muss
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    ABSTRACT: Pretreatment preferences for adjuvant therapy were examined and compared with actual treatment received. Before definitive surgery, women with node-negative breast cancer were asked to indicate their preference for adjuvant therapy in response to 3 different clinical scenarios. The scenarios provided precise risk, benefit, and side effect information with low-, moderate-, or high-risk risk of death from breast cancer. Contingency table and Spearman rank correlation coefficients were used to examine associations. Kruskal-Wallis rank sum tests were used for group comparisons, with the Friedman rank sum test being used for correlated samples. A total of 75 women enrolled between February 2002 and April 2005; 24% were aged > 65 years. After definitive surgery, 21% of women had ductal carcinoma in situ, and 89% had receptor-positive disease. There was a significant correlation between risk of recurrence and aggressiveness of treatment preferred (P < .001). After surgical staging, the high-risk group received more aggressive treatment compared with the low-risk group (P = .004). In the 51 women with invasive receptor-positive tumors, there was a significant difference (P = .002) in aggressiveness of treatment received based on risk of recurrence. Only 45% of the women received what they had preferred for the level of their risk before surgery. Women were more likely to receive a less aggressive therapy than they preferred initially (P = .0002). This study is among the first to correlate pretreatment preference for therapy with the actual therapy received. Less than half of women received their indicated preference before definitive surgery, with most women receiving less aggressive therapy. Future studies will need to examine this discrepancy.
    Clinical Breast Cancer 10/2010; 10(5):398-403. · 2.42 Impact Factor
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    ABSTRACT: Sentinel-lymph-node (SLN) surgery was designed to minimise the side-effects of lymph-node surgery but still offer outcomes equivalent to axillary-lymph-node dissection (ALND). The aims of National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-32 were to establish whether SLN resection in patients with breast cancer achieves the same survival and regional control as ALND, but with fewer side-effects. NSABP B-32 was a randomised controlled phase 3 trial done at 80 centres in Canada and the USA between May 1, 1999, and Feb 29, 2004. Women with invasive breast cancer were randomly assigned to either SLN resection plus ALND (group 1) or to SLN resection alone with ALND only if the SLNs were positive (group 2). Random assignment was done at the NSABP Biostatistical Center (Pittsburgh, PA, USA) with a biased coin minimisation approach in an allocation ratio of 1:1. Stratification variables were age at entry (≤ 49 years, ≥ 50 years), clinical tumour size (≤ 2·0 cm, 2·1-4·0 cm, ≥ 4·1 cm), and surgical plan (lumpectomy, mastectomy). SLN resection was done with a blue dye and radioactive tracer. Outcome analyses were done in patients who were assessed as having pathologically negative sentinel nodes and for whom follow-up data were available. The primary endpoint was overall survival. Analyses were done on an intention-to-treat basis. All deaths, irrespective of cause, were included. The mean time on study for the SLN-negative patients with follow-up information was 95·6 months (range 70·1-126·7). This study is registered with ClinicalTrials.gov, number NCT00003830. 5611 women were randomly assigned to the treatment groups, 3989 had pathologically negative SLN. 309 deaths were reported in the 3986 SLN-negative patients with follow-up information: 140 of 1975 patients in group 1 and 169 of 2011 in group 2. Log-rank comparison of overall survival in groups 1 and 2 yielded an unadjusted hazard ratio (HR) of 1·20 (95% CI 0·96-1·50; p=0·12). 8-year Kaplan-Meier estimates for overall survival were 91·8% (95% CI 90·4-93·3) in group 1 and 90·3% (88·8-91·8) in group 2. Treatment comparisons for disease-free survival yielded an unadjusted HR of 1·05 (95% CI 0·90-1·22; p=0·54). 8-year Kaplan-Meier estimates for disease-free survival were 82·4% (80·5-84·4) in group 1 and 81·5% (79·6-83·4) in group 2. There were eight regional-node recurrences as first events in group 1 and 14 in group 2 (p=0·22). Patients are continuing follow-up for longer-term assessment of survival and regional control. The most common adverse events were allergic reactions, mostly related to the administration of the blue dye. Overall survival, disease-free survival, and regional control were statistically equivalent between groups. When the SLN is negative, SLN surgery alone with no further ALND is an appropriate, safe, and effective therapy for breast cancer patients with clinically negative lymph nodes. US Public Health Service, National Cancer Institute, and Department of Health and Human Services.
    The Lancet Oncology 10/2010; 11(10):927-33. · 25.12 Impact Factor
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    ABSTRACT: The demonstration of human papillomavirus (HPV) in 99.7% of cervical carcinoma surgical specimens from around the world required investigations by multiple alternative polymerase chain reaction (PCR) assays. A similar approach may therefore be necessary to best characterize HPV prevalence and genotype distribution among cervical cytology samples. In an earlier study, 752 of 799 (94.1%) abnormal and 82 of 300 (27.3%) normal cytology specimens tested HPV positive after PCR using GP5+/6+primers. This study has reinvestigated the "HPV negative" abnormal samples (20 atypical squamous cells of undetermined significance, 5 low-grade squamous intraepithelial lesion, 14 atypical squamous cells, cannot exclude HSIL, 6 high-grade squamous intraepithelial lesion) and an age-matched cohort of "HPV negative" normal (negative for an intraepithelial lesion or malignancy) samples by PCR using PGMY09/11, FAP59/64, and LCR-E7 primers. PGMY09/11-GP5+/6+ nested PCR was performed on samples that were HPV negative by PGMY09/11 PCR. After the first 3 assays, HPV was detected in 41 of 45 (91.1%) abnormal and in 10 of 47 (21.3%) normal samples (P<0.0001). Eighteen HPV genotypes were detected and in some samples the genotype that was identified differed between the tests. The nondetection of common HPV genotypes (eg, HPVs 6, 11, 16, and 18) was notable. High-grade histopathology was found for 2 patients with HPV52-positive cytopathology. Combined with our earlier study, HPV (40 different genotypes) is shown in 99.5% of abnormal samples (99.8% inclusive of the nested PCR data). These findings show that HPV genotype and prevalence estimates are dependent on the method(s) of detection and indicate that suboptimal analytical sensitivity for one or more of the less common high-risk HPV genotypes could lead to impaired clinical sensitivity. HPV may be causal in almost every instance of abnormal cervical cytology; however, passenger HPV that is incidental to an abnormality may also have been detected.
    Diagnostic molecular pathology: the American journal of surgical pathology, part B 09/2010; 19(3):144-50. · 1.58 Impact Factor
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    ABSTRACT: Three year post-surgical morbidity levels were compared between patients with negative sentinel lymph node dissection alone (SLND) and those with negative sentinel node dissection and negative axillary lymph node dissection (ALND) in the NSABP B-32 trial. A total of 1,975 ALND and 2,008 SLND node negative breast cancer patients had shoulder range of motion and arm volumes assessed along with self reports of arm tingling and numbness. Relative shoulder abduction deficits and relative arm volume differences between ipsilateral and contralateral arms were calculated. Shoulder abduction deficits >or=10% peaked at 1 week for the ALND (75%) and SLND (41%) groups. Arm volume differences >or=10% at 36 months were evident for the ALND (14%) and SLND (8%) groups. Numbness and tingling peaked at 6 months for the ALND (49%, 23%) and SLND (15%, 10%) groups. Logistic regression correlates of residual morbidity included treatment group, age, handedness, tumor size, systemic chemotherapy, and radiation to the axilla. Although residual morbidity for both treatment groups was evident, the results of the NSABP B-32 study indicate the superiority of the SLND compared to the ALND treatment approach relative to post-surgical morbidity outcomes over a 3-year follow-up period.
    Journal of Surgical Oncology 08/2010; 102(2):111-8. · 2.64 Impact Factor
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    ABSTRACT: To evaluate the efficacy of an Internet behavioral weight loss program; and determine if adding periodic in-person sessions to an Internet intervention improves outcomes. 481 healthy overweight adults (28% minority) were randomized to one of 3 delivery methods of a behavioral weight loss program with weekly meetings: Internet (n=161), InPerson (n=158), or Hybrid (Internet+InPerson, n=162). Outcome variables were weight at baseline and 6 months and percent of subjects achieving a 5 and 7% weight loss. The study took place in two centers in Vermont and Arkansas from 2003 to 2008. Conditions differed significantly in mean weight loss [8.0 (6.1) kg vs. 5.5 (5.6) kg vs. 6.0 (5.5) kg], for InPerson, Internet, and Hybrid respectively, p<0.01, n=462). Weight loss for InPerson was significantly greater than the Internet and Hybrid conditions (p<0.05). Although the proportion reaching a 5% weight loss did not differ, the proportion losing 7% did differ significantly (56.3% vs. 37.3% vs. 44.4% for InPerson, Internet, and Hybrid respectively, p<0.01). These results demonstrate that the Internet is a viable alternative to in-person treatment for the delivery and dissemination of a behavioral weight-control intervention. The addition of periodic in-person sessions did not improve outcomes.
    Preventive Medicine 08/2010; 51(2):123-8. · 3.50 Impact Factor
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    ABSTRACT: Mass media interventions for reduction of youth cigarette smoking have been recommended based on a broad array of evidence, although few randomized community trials have been reported. Four matched pairs of independent media markets were identified; one member of each pair was randomized to receive the intervention. School surveys were conducted in all markets, in 2001 before (n=19,966) and in 2005 after (n=23,246) the interventions were completed. Grade 7-12 students from public schools in these eight medium-sized metropolitan areas participated in the summative evaluations; Grades 4-12 students were targeted to receive mass media interventions in four of these markets. Four simultaneous campaigns consisting of specially developed messages based on behavioral theory and targeted to defined age groups of racially and ethnically diverse young people were placed in popular TV, cable, and radio programming using purchased time for 4 years. Prevalence of youth smoking and psychosocial mediators of smoking. No significant impacts of these interventions on smoking behaviors or mediators were found for the overall samples. A positive effect was found for one mediator in subgroups. Among Hispanic participants a marginally favorable effect on smoking prevalence and significant effects on mediators were found. General awareness of smoking prevention TV messages was slightly higher over time in the intervention areas. Mass media interventions alone were unable to induce an incremental difference in youth smoking prevalence, probably because of a relatively strong tobacco control environment that included a substantial national smoking prevention media campaign.
    American journal of preventive medicine 07/2010; 39(1):53-62. · 4.24 Impact Factor
  • Lancet Oncology - LANCET ONCOL. 01/2010; 11(10):927-933.
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    ABSTRACT: Family history (FH) assessment is useful in identifying and managing patients at increased risk for cancer. This study assessed reported FH quality and associations with physician perceptions. Primary care physicians practicing in two northeastern U.S. states were surveyed (n = 880; 70% response rate). Outcome measures of FH quality were extent of FH taken and ascertaining age at cancer diagnosis for affected family members. Predictors of quality measured in this survey included: perceived advantages and disadvantages of collecting FH information, knowledge of management options, access to supportive resources, and confidence in ability to interpret FH. Reported collection of information regarding second degree blood relatives and age of diagnosis among affected relatives was low. All hypothesized predictors were associated with measures of FH quality, but not all were consistent independent predictors. Perceived advantages of taking a family history, access to supportive resources, and confidence in ability to identify and manage higher risk patients were independent predictors of both FH quality measures. Perceived disadvantages of taking a family history was independently associated one measure of FH quality. Knowledge of management options was not independently associated with either quality measure. Modifiable perception and resource factors were independently associated with quality of FH taking in a large and diverse sample of primary care physicians. Improving FH quality for identification of high risk individuals will require multi-faceted interventions.
    BMC Family Practice 01/2010; 11:45. · 1.61 Impact Factor
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    ABSTRACT: The National Surgical Adjuvant Breast and Bowel Project B-32 trial was designed to determine whether sentinel lymph node resection can achieve the same therapeutic outcomes as axillary lymph node resection but with fewer side effects and is one of the most carefully controlled and monitored randomized trials in the field of surgical oncology. We evaluated the relationship of surgeon trial preparation, protocol compliance audit, and technical outcomes. Preparation for this trial included a protocol manual, a site visit with key participants, an intraoperative session with the surgeon, and prerandomization documentation of protocol compliance. Training categories included surgeons who submitted material on five prerandomization surgeries and were trained by a core trainer (category 1) or by a site trainer (category 2). An expedited group (category 3) included surgeons with extensive experience who submitted material on one prerandomization surgery. At completion of training, surgeons could accrue patients. Two hundred twenty-four surgeons enrolled 4994 patients with breast cancer and were audited for 94 specific items in the following four categories: procedural, operative note, pathology report, and data entry. The relationship of training method; protocol compliance performance audit; and the technical outcomes of the sentinel lymph node resection rate, false-negative rate, and number of sentinel lymph nodes removed was determined. All statistical tests were two-sided. The overall sentinel lymph node resection success rate was 96.9% (95% confidence interval [CI] = 96.4% to 97.4%), and the overall false-negative rate was 9.5% (95% CI = 7.4% to 12.0%), with no statistical differences between training methods. Overall audit outcomes were excellent in all four categories. For all three training groups combined, a statistically significant positive association was observed between surgeons' average number of procedural errors and their false-negative rate (rho = +0.188, P = .021). All three training methods resulted in uniform and high overall sentinel lymph node resection rates. Subgroup analyses identified some variation in false-negative rates that were related to audited outcome performance measures.
    CancerSpectrum Knowledge Environment 09/2009; 101(19):1356-62. · 14.07 Impact Factor
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    ABSTRACT: The National Surgical Adjuvant Breast and Bowel Project B-32 trial is examining whether patients with initially negative sentinel lymph nodes (SLNs) who have occult metastases detected on deeper levels and cytokeratin immunohistochemistry stains are at risk for regional or distant metastases. The experimental B-32 protocol was designed to detect metastases larger than 1.0 mm by examining sections approximately 0.5 and 1.0 mm deeper into the paraffin blocks (2 levels; wide spacing). This pilot quality assurance study compares detection rates to a comprehensive protocol designed to detect metastases larger than 0.2 mm (multilevel; narrow spacing). All SLNs were sectioned grossly at close to 2.0 mm and all sections embedded in paraffin blocks. For clinical treatment, a single hematoxylin and eosin section was examined from each block. For 54 cases with 1 to 5 SLNs and all SLNs negative, additional cytokeratin immunohistochemistry sections were evaluated every 0.18 mm through the block until no tissue remained. Twenty of 176 (11.4%) blocks harbored occult metastases; the B-32 protocol detected metastases in 11 blocks (6.3%) and 9 additional blocks (5.1%) with metastases were detected on sections that would not have been evaluated (P=0.002; correlated proportions). Median number of levels examined per block on the comprehensive protocol was 11 (range: 3 to 26); the B-32 protocol was fixed at 2 levels (median 2; range: 1 to 2). Median thickness of node sections in the block was 2.1 mm (range: 0.7 to 4.8 mm) and the modal thickness was 2.3 mm. Although more comprehensive sectioning of SLNs detects additional micrometastases, the data suggest diminishing returns and reduced cost effectiveness for the comprehensive strategy.
    The American journal of surgical pathology 09/2009; 33(11):1583-9. · 4.06 Impact Factor
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    ABSTRACT: Ductal carcinoma in situ (DCIS) often requires some method of localization to achieve breast-conserving therapy. The purpose of this study was to compare the efficacy of intraoperative ultrasound versus mammographic needle localization (MNL) for partial mastectomy in DCIS. Data were collected from a Breast Cancer Surgery Database. All DCIS cases undergoing partial mastectomy (PM) were identified. Margin status, re-excision rates, and cost were determined for both groups. A total of 155 patients undergoing PM for DCIS were identified from the database. In the 96 patients undergoing ultrasound-guided PM (Group 1), the positive margin rate was 10.4%, and close margins (<1 mm) were observed in 22.9% after initial surgery. There were 59 patients who underwent MNL (Group 2); the positive margin rate was 11.9%, and close margins were observed in 27.1%. The difference between positive and close margins in Group 1 versus Group 2 was not statistically significant. The rate of re-excision was 20.8% for Group 1 and 30.5% for Group 2, resulting in 1.23 and 1.37 operations per patient, respectively. The average cost of an intraoperative ultrasound at our institution was $933 and $1858 for MNL (excluding cost of radiologic interpretation), a difference of $925 per case. Our study showed equivalent rates of positive margins and re-excision between intraoperative ultrasound and MNL when performing PM for nonpalpable DCIS. Considering the more invasive nature and increased cost of MNL, we consider surgeon-performed intraoperative ultrasound, when possible, the more cost-effective and practical procedure for patients with DCIS.
    Annals of Surgical Oncology 05/2009; 16(5):1164-9. · 4.12 Impact Factor
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    ABSTRACT: Internet-based weight control programs have been showing promising results; however, as of yet, it is unclear which website components are critical for producing and maintaining weight loss. The aim of this study is to examine the utilization patterns of a weight control website and the relationship of the Web features to weight loss and maintenance. One hundred and twenty three (N = 123) participants took part in a 12-month behavioral weight control program over the Internet and their website utilization patterns were monitored. When examining the clustering of Web feature utilization and weight loss, the "feedback" factor (progress charts, physiological calculators, and past journals) was the best predictor of weight loss during the treatment period (baseline to 6 months), while the "social support" factor (Web chats and biographical information/e-mail addresses of participants) was the best predictor during maintenance. Weight loss in an online weight control program was related to dynamic Web features that provided feedback, support, and motivation to participants.
    Telemedicine and e-Health 11/2008; 14(8):775-82. · 1.40 Impact Factor
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    ABSTRACT: The goals of this clinical study were to develop a clinically relevant technique of targeting the sentinel lymph nodes for surgical removal in breast cancer patients and to determine the accuracy of the sentinel node for predicting whether regional metastases have occurred.One hundred fifty-seven patients with breast cancer and clinically negative lymph nodes had 0.2 to 1.0 mCi of a radiopharmaceutical injected into the breast around the primary cancer. All patients underwent completion lymphadenectomy immediately following sentinel node resection. The nodes were analyzed pathologically to determine which nodes contained metastases.A considerable variation was observed in the ability of different radiopharmaceutical agents to selectively label the sentinel node. Of those evaluated, 1 mCi technetium sulfur colloid in a volume of 8 ml provided the best labeling rate (29/29 = 100%). Of 119 patients in which a sentinel node was identified, 41 had pathologically positive nodes and in only 2 cases was the sentinel node not one of the pathologically positive nodes (false-negative rate 4.9%). The mean number of sentinel nodes was 3.There was considerable variation in the ability of lymphoscintigraphic agents to selectvely label the sentinel lymph node in breast cancer agents. Technetium sulfur colloid appears to successfully label the sentinel nodes in >90% breast cancer patients and was the best agent of the group evaluated. The pathology of the sentinel lymph node has a high accuracy for predicting whether regional lymph node metastases have occurred.
    The Breast Journal 10/2008; 4(2):67 - 74. · 1.83 Impact Factor
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    ABSTRACT: HIV/AIDS is occurring with increasing frequency in rural areas of the United States, and people living with HIV/AIDS in rural communities report higher levels of perceived stigma than their more urban counterparts. The extent to which stigmatized individuals perceive stigma could be influenced, in part, by prevailing community attitudes. Differences between rural and more metropolitan community members' attitudes toward people with HIV/AIDS, however, have rarely been examined. This study investigated motivation to control prejudice toward people with HIV/AIDS among non-infected residents of metropolitan, micropolitan, and rural areas of rural New England. A total of 2,444 individuals were identified through a random digit dialing sampling scheme, and completed a telephone interview to determine attitudes and concerns about a variety of health issues. Internal or external motivation to control prejudice was examined using a general linear mixed model approach, with independent variables including age, gender, community size, and perceived indentifiability within one's community. Results showed that community size, by itself, was not related to motivation to control prejudice. However, there was a significant interaction between community size and community residents' perceptions about the extent to which people in their communities know who they are. Our results indicate that residents of rural areas, in general, may not show a higher level of bias toward people with HIV/AIDS. The interaction between community size and perceived identifiability, however, suggests that motivation to control prejudice, and potentially the subsequent expression of that prejudice, is more complex than originally thought.
    The Journal of Rural Health 01/2008; 24(3):285-91. · 1.44 Impact Factor
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    ABSTRACT: The goals of axillary-lymph-node dissection (ALND) are to maximise survival, provide regional control, and stage the patient. However, this technique has substantial side-effects. The purpose of the B-32 trial is to establish whether sentinel-lymph-node (SLN) resection can achieve the same therapeutic goals as conventional ALND but with decreased side-effects. The aim of this paper is to report the technical success and accuracy of SLN resection plus ALND versus SLN resection alone. 5611 women with invasive breast cancer were randomly assigned to receive either SLN resection followed by immediate conventional ALND (n=2807; group 1) or SLN resection without ALND if SLNs were negative on intraoperative cytology and histological examination (n=2804; group 2) in the B-32 trial. Patients in group 2 underwent ALND if no SLNs were identified or if one or more SLNs were positive on intraoperative cytology or subsequent histological examination. Primary endpoints, including survival, regional control, and morbidity, will be reported later. Secondary endpoints are accuracy and technical success and are reported here. This trial is registered with the Clinical Trial registry, number NCT00003830. Data for technical success were available for 5536 of 5611 patients; 75 declined protocol treatment, had no SLNs removed, or had no SLN resection done. SLNs were successfully removed in 97.2% of patients (5379 of 5536) in both groups combined. Identification of a preincision hot spot was associated with greater SLN removal (98.9% [5072 of 5128]). Only 1.4% (189 of 13171) of SLN specimens were outside of axillary levels I and II. 65.1% (8571 of 13 171) of SLN specimens were both radioactive and blue; a small percentage was identified by palpation only (3.9% [515 of 13 171]). The overall accuracy of SLN resection in patients in group 1 was 97.1% (2544 of 2619; 95% CI 96.4-97.7), with a false-negative rate of 9.8% (75 of 766; 95% CI 7.8-12.2). Differences in tumour location, type of biopsy, and number of SLNs removed significantly affected the false-negative rate. Allergic reactions related to blue dye occurred in 0.7% (37 of 5588) of patients with data on toxic effects. The findings reported here indicate excellent balance in clinical patient characteristics between the two randomised groups and that the success of SLN resection was high. These findings are important because the B-32 trial is the only trial of sufficient size to provide definitive information related to the primary outcome measures of survival and regional control. Removal of more than one SLN and avoidance of excisional biopsy are important variables in reducing the false-negative rate.
    The Lancet Oncology 11/2007; 8(10):881-8. · 25.12 Impact Factor
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    ABSTRACT: Mass media interventions are among the strategies recommended for youth cigarette smoking prevention, but little is known about optimal methods for reaching diverse youth audiences. Grades 4 through 12 samples of youth from four states (n = 1,230) rated smoking-prevention messages in classroom settings. Similar proportions of African American, Hispanic, and White youth participated. Impact of audience characteristics on message appeal ratings was assessed to provide guidance for audience segmentation strategies. Age had a strong effect on individual message appeal. The effect of gender also was significant. Message ratings were similar among the younger racial/ethnic groups, but differences were found for older African American youth. Lower academic achievement was associated with lower appeal scores for some messages. Age should be a primary consideration in developing and delivering smoking-prevention messages to youth audiences. The unique needs of boys and girls and older African American adolescents should also be considered.
    Health Education &amp Behavior 09/2007; 34(4):578-93. · 1.54 Impact Factor
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    ABSTRACT: Theory-driven, mass media interventions prevent smoking among youth. This study examined effects of a media campaign on adolescent smoking cessation. Four matched pairs of media markets in four states were randomized to receive or not receive a 3-year television/radio campaign aimed at adolescent smoking cessation based on social cognitive theory. The authors enrolled 2,030 adolescent smokers into the cohort (n = 987 experimental; n = 1,043 comparison) and assessed them via annual telephone surveys for 3 years. Although the condition by time interaction was not significant, the proportion of adolescents smoking in the past month was significantly lower in the experimental than comparison condition at 3-year follow-up when adjusted for baseline smoking status. The media campaign did not impact targeted mediating variables. A media campaign based on social cognitive constructs produced a modest overall effect on smoking prevalence among adolescents, but the role of theory-based constructs is unclear.
    Health Education &amp Behavior 07/2007; 36(4):642-59. · 1.54 Impact Factor

Publication Stats

3k Citations
388.33 Total Impact Points

Institutions

  • 1987–2014
    • University of Vermont
      • • College of Medicine
      • • Department of Pathology
      • • Department of Psychology
      • • Department of Surgery
      • • Office of Health Promotion Research
      Burlington, Vermont, United States
  • 2000
    • Burlington College
      Burlington, Vermont, United States