Purpose The objectives of the present study were to evaluate whether investigator bias influenced the Convergence Insufficiency Symptom Survey (CISS) scores of children with normal binocular vision (NBV) in our original validation study, reevaluate the usefulness of the cut-off score of 16, and reexamine the validity of the CISS. Methods Six clinical sites participating in the Convergence Insufficiency Treatment Trial (CITT) enrolled 46 children 9 - <18 years with NBV. Examiners masked to the child’s binocular vision status administered the CISS. The mean CISS score was compared to that from the children with NBV in the original, unmasked CISS study and also to that of the 221 symptomatic CI children enrolled in the CITT. Results The mean (±SD) CISS score for 46 subjects with NBV was 10.4 (±8.1). This was comparable to that from our prior unmasked NBV study (mean = 8.1(± 6.2); p = 0.11), but was significantly different from that of the CITT CI group (mean = 29.8 ± 9.0; p < 0.001). Eighty-three percent of these NBV subjects scored less than 16 on the CISS, which is not statistically different from the 87.5% found in the original unmasked study (p = 0.49). Conclusions Examiner bias did not affect the CISS scores for subjects with NBV in our prior study. The CISS continues to be a valid instrument for quantifying symptoms in 9 to <18 year-old children and these results confirm the validity of a cut-point of ≥ 16 in distinguishing children with symptomatic CI from those with NBV.

The results presented in this report demonstrate that the sequential use of screening immunoassays before immunoblot testing can significantly reduce both the number of immunoblot tests and proportion of indeterminate results, without impacting sensitivity, thereby improving algorithm efficiency and simplifying donor management.

No abstract

Our analysis suggests that a combination of indicators can be used to help clarify RIBA-3-indeterminate, RNA-negative results. Specifically, donors with high S/CO ratios on a screening immunoassay, RIBA-3 reactivity to c22p or c33c with band intensity of 2+ or greater, without a previous history of negative or BFR donations and with an identifiable risk factor, have a high probability of representing true anti-HCV rather than nonspecific reactivity.

Although high s/co ratios were predictive of confirmed-positive results in all four assays, a number of confirmed-positive samples gave low values while some biologic false-positive samples showed high values. As the s/co ratio distributions for BFR and confirmed-positive results overlapped for all four PRISM assays, this study highlights the importance of serologic confirmatory testing and the need for caution when using screening IA results to assign a final donor status.

This study demonstrated that at least five of six HCV NAT yield donors were in the pre- or early antibody seroconversion phase of infection. The observation that one yield donor demonstrated HCV RNA that fluctuated above and below the limit of detection of the primary NAT-screening assay supports the maintenance of both NAT and antibody screening for HCV. Follow-up testing of suspected yield donors revealed that the primary and alternate anti-HCV immunoassays had different performance characteristics, depending on the specificity of the donor's early anti-HCV response.

he Intermittent Exotropia Questionnaire (IXTQ) is a patientderived, intermittent exotropia-specific instrument designed to evaluate health-related quality of life (HRQOL) in children with intermittent exotropia and their parents. 1,2 The IXTQ consists of 3 parts: the 12-item child IXTQ (completed by the child to assess the child's HRQOL), the 12-item proxy IXTQ (completed by the parent to assess the child's HRQOL), and the 17-item parent IXTQ (completed by the parent regarding his or her own HRQOL). 1 The child and proxy questionnaires each have a single subscale. The parent questionnaire contains 3 subscales: psychosocial, function, and surgery. The IXTQ is reliable and valid for assessing HRQOL in children with intermittent exotropia. [1][2][3] It is available for download free of charge at http://pedig.jaeb.org/.The IXTQ was originally developed using classical test theory. Rasch analysis may be used to modify and improve existing HRQOL instruments. [4][5][6][7][8][9] In the present study, Rasch analysis was used to refine the existing IXTQ, removing items that do not contribute meaningful information to the instrument and ensuring that response options are properly interpreted. Methods Patient CohortParents gave written informed consent, and children gave written assent when required. The protocol was approved by the institutional review boards of the Mayo Clinic, Jaeb Center for Health Research, and other local sites involved in the study. Data were collected and analyzed in accordance with the Health Insurance Portability and Accountability Act guidelines. The IXTQ was completed by 575 parents of 575 children aged 1 through 16 years with intermittent exotropia at the time of their child's clinic examination, enrolled from May 15, 2008, through July 24, 2013. The 295 children aged 5 years or older completed the age-appropriate child IXTQ. Parents and children completed the IXTQ as part of routine care in the strabismus practice of one of the authors (J.M.H., n = 110) or at the enrollment examination for 1 of 2 ongoing randomized clinical trials being conducted by the Pediatric Eye Disease Investigator Group (NCT 01032603 [n = 69] and NCT 01032330 [n = 396]). Child questionnaires were administered to children aged 5 through 7 years by study personnel. All 8-to 17-year-old child, proxy, and parent questionnaires were self-administered. Patient demographics are reported in eTable 1 in the Supplement. Statistical AnalysisBefore Rasch analysis, items with floor and ceiling effects on the child, proxy, and parent IXTQs were eliminated as described in the eMethods in the Supplement. Rasch analysis was performed on each of the 4 IXTQs using the analytic methods that we have applied previously (eMethods in the Supplement). 9 The performance and structure of the Rasch-IMPORTANCE The Intermittent Exotropia Questionnaire (IXTQ) is a patient, proxy, and parental report of quality of life specific to children with intermittent exotropia. We refine the IXTQ using Rasch analysis to improve reliability and validity.OBSERVATI...

Annual cervical cancer screening with Papanicolaou (Pap) and human papillomavirus (HPV) testing after stem cell transplant (SCT) is recommended, but the uptake is unknown. We aimed to determine the prevalence and predictors of cervical cancer screening in patients with hematologic malignancies. We searched MarketScan Commercial Claims database for women who underwent allogeneic or autologous SCT. The primary outcome was cervical cancer screening, defined as procedures or abnormal results for HPV and/or Pap testing according administrative codes within 2 years after SCT. A multivariable logistic regression model was fitted with cancer type, SCT year, age, geographic area, insurance plan, comorbidity, and presence of graft-versus-host disease (GVHD).The study included 1484 patients; 1048 patients (70.6%) had autologous and 436 (29.4%) allogeneic SCT. Mean age was 52.5 years. Overall, 660 patients (44.5%) had screening within 2 years after SCT, 214 (49.1%) with allogeneic SCT and 446 (42.6%) with autologous SCT (P = .02). In the allogeneic SCT group, patients with GVHD had a lower rate of screening than patients without GVHD (42.5% versus 55.4%, P < .01), and GVHD was associated with lower odds of screening (odds ratio, .50; 95% confidence interval, .32 to .79). In the autologous SCT group, patients with comorbid medical conditions had a lower rate of screening than patients without comorbidity (36.0% versus 45.7%, P < .01). In both allogeneic and autologous SCT groups older patients had lower odds of screening. Cervical cancer screening rates after SCT are low, particularly in patients with GVHD, who are at significant risk of second malignancies. Future work is needed to develop strategies to increase uptake.