Biomedical subjects

W Stephen Black-Schaffer

Publications and source records attributed to W Stephen Black-Schaffer.

3 recordsLinked to original sources

PubMed2006

Human papillomavirus testing using hybrid capture II with SurePath collection: initial evaluation and longitudinal data provide clinical validation for this method.

BACKGROUND: Testing for human papillomavirus (HPV) is an integral part of equivocal cervical cytology triage. Clinical validation of non-FDA (Food and Drug Administration)-approved methods is therefore important because of the high volume of such tests and the implications for missed high-grade lesions if test performance is not optimal. METHODS: A preinitiation study and 17 months of follow-up data using Hybrid Capture II (HC II) HPV detection with SurePath (SP) sample collection were analyzed. Results of HPV tests on abnormal cytology samples were collected and compared with follow-up results. HPV-positive rates were determined in cases of low-grade squamous intraepithelial lesion (LSIL) and high-grade squamous intraepithelial lesion (HSIL), and follow-up rates of cervical intraepithelial neoplasia (CIN) were determined in HPV-positive and -negative cases of atypical squamous cells of unknown significance (ASC-US). Rates were compared with published data using FDA-validated methods. RESULTS: The preinitiation study showed the test method to be 100% sensitive for the detection of LSIL (20 cases) and HSIL (8). The ASC-US follow-up study (2319 cases with 625 having biopsy results) showed that the rate of CIN III+ in HPV +/- cases was 7.8%/1.4%, and of CIN II+ was 17.5%/4.3%, respectively. The positive predictive values/negative predictive values (PPV/NPVs) (CIN II+) for the test were 17.5%/95.7%, respectively. CONCLUSIONS: Published FDA-validated HPV testing follow-up data show that the expected rates of CIN III+ and CIN II+ in the HPV-negative ASC-US population are 1.4% and 5%, respectively, with PPV/NPVs (CIN II+) of 20%/99%, respectively. By comparison, the present data using HC II with SP show strong similarity, indicating clinical validity for the use of this method.

Carcinoma, Squamous Cell↗

PubMed2006

Resident physician opinions on autopsy importance and procurement.

The national decline in hospital autopsy cases negatively impacts physician education and medical quality control to an unknown degree. The current non-medicolegal autopsy rate is less than 5% of hospital deaths. This study compares internal medicine and pathology resident physician perceptions of the autopsy, including the importance, procurement, technique, and the pathologist-internist interaction. An 84-item survey based on autopsy literature was designed, piloted, and distributed to 214 residents at a single 800+ bed tertiary care academic teaching hospital (Massachusetts General Hospital, Boston) to accomplish this goal. Completed surveys were obtained from 72% of medicine (n = 118) and 84% of pathology (n = 42) residents. Residents strongly agree on the importance of autopsies for education, answering clinical questions, public health, and research. Autopsy rates are deemed inadequate. Internists are comfortable requesting autopsies, but report insufficient guidance and difficulty with answering technical questions. Although not requested on all hospital deaths, internists are more likely to initiate an autopsy request than a decedent's family, and worry significantly less about institutional costs and malpractice litigation than pathologists believe. Internists expressed interest in having an instructional brochure to give families, observing an autopsy, and having increased communication and support with autopsies from pathology residents. The main reasons why autopsy consent is not requested (it is unpleasant, cause of death is known, family is upset or seems unwilling) and why families refuse (patient has suffered enough, body may be handled disrespectfully, religious/moral objections, lack information) were similar for both resident groups. Despite their decline, autopsies still remain important to medicine as indicated by internal medicine and pathology residents at a large academic center. Improving autopsy education, enhancing availability of resources, and strengthening the pathologist-internist collaboration may serve to heighten awareness and ultimately procurement.

Attitude of Health Personnel↗

PubMed2003

Choosing between competing technologies in the cytology laboratory.

Technological change often is internal to anatomic pathology services. When new technology requires collaborative development with clinical staff, it is important to systematically approach the rationale for the new technology, and be prepared to deal with its medical, financial, and, sometimes, even personal implications. Such a systematic approach involves sequentially evaluating the acceptability and the potential benefits of technologic alternatives among the laboratory leadership, with each potential vendor, the laboratory staff, and the clinical and institutional leadership, and must ultimately include effective communication with the entire clinical community. Among the benefits of such a systematic approach are resiliency of the process when challenged, and credibility of its leadership, within and outside of the laboratory.

Cell Biology↗