A self-contained, portable, pain rating instrument that provides an immediate result for documentation purposes was developed to improve pain assessment in cancer patients. The Hopkins Pain Rating Instrument (HPRI) is a 5 x 20 cm plastic visual analogue scale (VAS) with a sliding marker that moves within a groove that measures 10 cm. The side facing the patient resembles a traditional VAS while the opposite side is marked in cm to quantify pain intensity. This psychometric study, which employed a descriptive correlational design, evaluated the reliability and validity of the HPRI by comparing it with a traditional VAS and verbal descriptor scale (VDS). Outpatients with and without pain and inpatients with pain rated their major pain site with the three instruments, which were presented in random order. This was followed by a mental status exam and re-rating of pain with the same instruments to assess test--retest reliability. Completing the study were 71 patients with a variety of cancers and a mean age of 52.8 years. Of these patients, 68% had pain and 54% were receiving opioid analgesics. The most common pain sites were the back, leg, and epigastric areas. On initial and repeat testing, there were high correlations between the HPRI and the VAS (r = 0.99, P less than 0.0001) and the VDS (r = 0.85, P less than 0.0001). The correlation coefficients for test--retest reliability for the HPRI, VAS, and VDS were 0.97, 0.97, and 0.94 (P less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Purpose: Ductal lavage, a technique used to sample epithelial cells from breast ducts, has potential use in risk assessment and biomarker evaluation among women at increased risk for breast cancer. However, little is known about the reliability of the procedure. Methods: We evaluated the reliability of nipple aspirate (NAF) and ductal lavage at two time points 6 months apart in women at increased risk for breast cancer. Eligible women had a 5-year Gail risk z1.66% or lifetime risk of >20%, and/or a family history or personal history of breast cancer. All ducts that produced NAF were cannulated. The k statistic was used to evaluate reliability of NAF production, cellular yield, and cytologic diagnosis. Results: Sixty-nine women (mean age, 47 years) were enrolled over 35 months. Forty-seven returned for a second visit. At baseline, 65% of premenopausal and 41% of postmenopausal women produced NAF (P = 0.05), of which 72% underwent successful lavage of at least one duct. Samples of inadequate cellular material for diagnosis were significantly more likely in postmenopausal women than in premenopausal women (P = 0.04). Of the women who returned for a second visit, 18 of 24 who produced NAF had at least one duct successfully cannulated. Twenty-four ducts in 14 women were lavaged twice. Among these ducts, cellular yield for the two time points was inconsistent (k = 0.33 F 0.13), and only fair cytologic agreement was observed (k = 0.32 F 0.15). Ductal lavage was associated with moderate discomfort. Conclusion: Currently, the use of ductal lavage is limited by technical challenges in duct cannulation, inconsistent NAF production, a high rate of inadequate cellular material for diagnosis, fair cytologic reproducibility, and low participant return rates.

The reproducibility of a test result is a critical component of its clinical utility. Little information is available concerning the intrarater reproducibility of cytologic assessments. This study evaluated the reproducibility of cytologic interpretation of epithelial cells obtained from ductal lavage (DL), a minimally invasive method used to obtain sample cells from breast tissue. Two cytospin slides were made for each duct sampled. Slides with <10 cells were considered inadequate to make a diagnosis; the remaining slides were classified into mildly atypical, markedly atypical, and malignant cells. Each pair of slides were classified by the more serious diagnosis. DL samples from 100 ducts were independently blind-reviewed by two experienced cytopathologists. All abnormal slides and a random sample of normal slides and slides identified as inadequate for diagnosis (n = 43) were rereviewed. The k for intrarater agreement was 0.59 F 0.10 for cytopathologist 1 and 0.33 F 0.08 for cytopathologist 2. The k for interrater agreement of slides from 100 ducts was 0.46 F 0.07. The interrater agreement of the slides that were rereviewed was k = 0.27 F 0.09. Fair to moderate intrarater and interrater agreement of DL cytology was observed. Low intrarater and interrater cytologic consistency may compromise the interpretation of clinical studies of DL. (Cancer Epidemiol Biomarkers Prev 2006;15(12):2553 -6)

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