Citations

ABSTRACTIntroductionThe clinical significance of striational antibodies (StrAbs) detected in the course of paraneoplastic antibody testing is unknown.MethodsWe compared all 203 striational antibody (StrAb)‐seropositive patients identified (2004–2005) during evaluation for paraneoplastic antibodies with age‐ and sex‐matched seronegative controls.ResultsThymoma and myasthenia gravis (MG) were significantly more common among cases (P<0.0001). Cancers more rarely detected after StrAb detection were adenocarcinoma in 5 patients and sarcoma in 3 patients. All patients who had a cancer identified after StrAb testing had a titer of ≥1:7680 or a coexisting muscle AChR‐binding antibody. Autoimmune disorders more commonly observed among cases (with any StrAb value) included: hypothyroidism; rheumatoid arthritis; and pernicious anemia (all P<0.05).ConclusionsStrAbs may serve as a diagnostic clue for an autoimmune diagnosis. There is a low likelihood of oncological significance in patients with StrAb titers <1:7680 without coexisting paraneoplastic Abs. Muscle Nerve, 2013

Background Patient-reported signs and symptoms are often the first indication of clinically relevant lymphedema. Objective The purpose of this study was to develop and assess the diagnostic accuracy of a screening questionnaire to detect lower-extremity lymphedema (LEL) among normal-weight women and women with obesity. Design This was a cross-sectional survey study. Methods The authors reviewed existing questionnaires assessing upper-extremity lymphedema (UEL) for potential questions and worked with content experts to generate new items. A draft questionnaire with 59 items was reviewed by 5 physicians and 5 physical therapists who specialized in lymphedema management and 5 female patients with clinically confirmed secondary LEL. A revised questionnaire with 45 items was administered by mail to 186 women with clinically confirmed LEL (n=116) or UEL (n=70). A total of 99 women (53.2% of 186) completed the mailed survey, and 28 women with lymphedema who were recruited directly in a lymphedema clinic waiting area also completed the survey. A parsimonious subset of items that best discriminated patients with and without LEL was identified using chi-square tests and logistic regression. Sensitivity and specificity for detecting LEL and positive and negative likelihood ratios (LR+, LR−) were estimated for the entire sample and for subsamples defined by obesity (body mass index ≥30 versus &lt;30 kg/m2), which may confound the accurate diagnosis of LEL. Results Questionnaires were completed by 127 women (LEL group, n=88; UEL group, n=39). A sum of 13 items (score range=0–52) was the most discriminating. Using a cutoff score of ≥5 points, the sensitivity and specificity for detecting LEL among all participants were 95.5% and 86.5%, respectively (LR+=7.1, LR−=0.05), and 94.8% and 76.5%, respectively (LR+=4.0, LR−=0.07), for participants who were obese. Limitations By enumerating a sample with a high prevalence of LEL, a spectrum bias may have been introduced, which may have affected the accuracy of the screening questionnaire. Conclusions The brief, 13-item self-report questionnaire is a sensitive and specific tool for detecting clinically relevant LEL among women, including those with a body mass index of ≥30 kg/m2.

Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.