Validation of the clinical performance and reproducibility of the NeuMoDx HPV assay self-sample workflow.

BACKGROUND: Human papillomavirus (HPV) testing on self-samples is a valid tool for cervical cancer screening. HPV self-sample workflows need to be clinically validated to ensure safe use in screening. OBJECTIVE: This study evaluated the fully automated NeuMoDx HPV Assay self-sample workflow that is compiled of the NeuMoDx HPV assay and the NeuMoDx 96/288 Molecular Systems, for clinical performance and reproducibility on Evalyn Brush-collected self-samples. METHODS: The clinical performance of the NeuMoDx HPV Assay self-sample workflow for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3+ was evaluated on 987 self-samples obtained from women attending national organized HPV-based cervical cancer screening by a noninferiority analysis relative to reference workflows using either HPV-Risk Assay or high-risk HPV GP5+/6+-PCR. Intra- and inter-laboratory reproducibility of the NeuMoDx HPV Assay self-sample workflow using both NeuMoDx 96 and 288 Molecular Systems was assessed on 520 self-samples in three laboratories. RESULTS: The clinical sensitivity and specificity of the NeuMoDx HPV Assay self-sample workflow for the detection of CIN2+ and CIN3+ were found to be non-inferior to the reference workflows using either HPV-Risk Assay or high-risk HPV GP5+/6+-PCR, with all p-values <0.034. The NeuMoDx HPV Assay self-sample workflow exhibited an intra-laboratory reproducibility of 94.4 % (95 %CI:92.5-96.1 %) with kappa value 0.86 (95 %CI:0.81-0.91). Inter-laboratory agreement was high (all ≥93.4 % and all kappa values ≥0.83). CONCLUSIONS: The NeuMoDx HPV Assay self-sample workflow demonstrated high clinical accuracy for CIN2+/3+ and high reproducibility. The NeuMoDx HPV Assay self-sample workflow can be considered suitable for cervical cancer screening purposes.

Mixed Reality Anatomy Using Microsoft HoloLens and Cadaveric Dissection: A Comparative Effectiveness Study.

PURPOSE: As the amount of curricular material required of medical students increases, less time is available for anatomy; thus, methods to teach anatomy more efficiently and effectively are necessary. In this randomized controlled trial, we looked at the effectiveness of a mixed reality (MR) device to teach musculoskeletal anatomy to medical students compared with traditional cadaveric dissection. METHOD: Participating students were divided into three cohorts. Cohort 1 first studied upper limb anatomy in MR followed by lower limb anatomy through cadaveric dissection. Cohort 2 studied upper limb anatomy with cadaveric dissection followed by lower limb anatomy in MR. After the six sessions, a third cohort of 33 students who never received any teaching in MR was recruited to participate in the final practical exams as a control group. All 64 students completed two practical exams with equivalent content, one in the cadaver lab and one using MR. RESULTS: The average scores were 73.8% + 12.3 on the cadaver exam and 74.2% + 13.0 in MR. There is no statistical difference between these scores (p > 0.05). A correlation was found between the MR practical exam and cadaver practical exam scores (r = 0.74, p < 0.01) across all students. CONCLUSIONS: To our knowledge, this study marks the first time that MR was compared with traditional anatomy learning modalities in a multi-session, group course. Our results clearly indicate that medical students, regardless of the study modality, performed similarly on the MR and the cadaver practical exams.

Influence of gross specimen sampling on the incidence of incidental prostatic carcinoma in cystoprostatectomy specimens of patients with bladder carcinoma.

Reported prostate cancer incidence rates vary greatly among cystoprostatectomy samples. We investigated how the thoroughness of prostate sampling influences prostatic carcinoma incidence in bladder cancer patients. In a retrospective study, 313 cystoprostatectomy cases of urinary bladder carcinoma were analysed for the presence of concurrent prostatic carcinoma. Patients were divided into two groups: patients who had undergone the operation before and after 2007, when a policy of preferably complete prostate sampling in cystoprostatectomy specimens was introduced at our institution. Cases processed after the 2007 recommended sampling changes had a significantly higher rate of incidental prostatic carcinoma and clinically significant prostatic carcinoma than the pre-2007 group (p < 0.0001 and p = 0.003, respectively). Complete prostate processing in cystoprostatectomy specimens results in a higher incidence of incidental prostatic carcinoma than with partial processing. More patients with clinically significant prostate cancer are consequently discovered. In conclusion, we believe that complete prostate sampling should be mandatory.

Distribution of Potato virus Y in potato plant organs, tissues, and cells.

The distribution of Potato virus Y (PVY) in the systemically infected potato (Solanum tuberosum) plants of the highly susceptible cultivar Igor was investigated. Virus presence and accumulation was analyzed in different plant organs and tissues using real-time polymerase chain reaction and transmission electron microscopy (TEM) negative staining methods. To get a complete insight into the location of viral RNA within the tissue, in situ hybridization was developed and optimized for the detection of PVY RNA at the cellular level. PVY was shown to accumulate in all studied leaf and stem tissues, in shoot tips, roots, and tubers; however, the level of virus accumulation was specific for each organ or tissue. The highest amounts of viral RNA and viral particles were found in symptomatic leaves and stem. By observing cell ultrastructure with TEM, viral cytoplasmic inclusion bodies were localized in close vicinity to the epidermis and in trichomes. Our results show that viral RNA, viral particles, and cytoplasmic inclusion bodies colocalize within the same type of cells or in close vicinity.

Mini-Mental State Examination: standardization and validation for the elderly Slovenian population.

For more than two decades Mini-Mental State Examination (MMSE) has been adapted to the Slovenian language as 'Kratek preizkus spoznavnih sposobnosti' (KPSS). In this study, we evaluated the influences of age and education on the KPSS score, looking for the cut-off point with the optimal ratio of sensitivity (SE) and specificity (SP) to support the use of the KPSS as a screening tool. During the years 2000-03 we examined 258 Slovenian volunteers. Volunteers were divided in two groups based on clinical criteria. A total of 189 were healthy, aged from 45 to 96 years, 69 were demented patients aged from 46 to 91 years, of both sexes, all different levels of education and different degrees of dementia. Median value, SE, SP, positive predictive power and negative predictive power were calculated at cut-off points 23/24, 24/25, 25/26 and 26/27. Younger age and higher education (at least 10 years of education) were each associated with higher KPSS scores. The Slovenian modification of the MMSE demonstrates an optimal cut-off score at 25/26 points for screening dementia in the Slovenian population, due to the best SP (75%)/SE (73%) ratio. The cut-off level 26/27 is recommended for screening highly educated persons.

Evaluation of intrapleural analgesia in the management of blunt traumatic chest wall pain: a clinical trial.

Intrapleural analgesia (IPA) has been successfully used for the relief of chest wall pain. Previous studies investigating its use have yielded conflicting results and have often suffered from design defects. The theoretical lower incidence of respiratory and circulatory depression with IPA suggests significant advantages over epidural analgesia. Patients who had documented blunt chest wall trauma were entered into a prospective, randomized, double-blinded, crossover, placebo-controlled study within 16 hours of their injury. Patients who were intubated or had significant trauma outside of the chest wall were not entered. Intrapleural catheters were placed using a standardized technique. Each patient received either a placebo solution of normal saline or a combination of bupivacaine/lidocaine in a blinded, crossover fashion for two 24-hour periods. Data were obtained on the use of supplementary narcotics, transcutaneous pCO(2') pulse oximetry, pulmonary function tests, and both patient and nursing evaluations of pain based on a numeric analogue scale. A series of 16 patients from a Level I trauma center were identified over a 2-year period. The ratio of male to female was approximately 2:1, with an age range of 35-80 years. There were no complications related to catheter placement or anesthetic toxicity. Mean values for patient and nursing pain ratings revealed opposite trends. We found no significant difference in the mean values for supplemental narcotic use, pCO(2') p0(2') forced vital capacity, or forced expiratory volume between the placebo and the test solution. Although previous studies have suggested that IPA may be beneficial in the management of chest wall pain, this was not confirmed in our study for blunt chest injuries. The addition of IPA to the more traditional use of opioid analgesics was not more effective for management of blunt chest wall pain. Despite our small patient population (n = 16), the crossover design should have allowed clinically significant differences to become evident (alpha value = 0.95). A review of the literature and a historical basis for the evolution in the management of this type of pain is included.

Rehabilitation of the burned hand: questionnaire results.

Burns to the hand can cause anatomical and functional limitations due to burn sequelae and treatment obstacles that arise during the rehabilitation process. A questionnaire consisting of four open-ended questions was distributed at the 1993 American Burn Association Breakfast Session, "Rehabilitation of the Burned Hand." The questionnaire was designed to gather information regarding common postburn deformities and treatment obstacles that occur in the acute and postacute phase of burn rehabilitation. Information was collected from 38 respondents and frequency distributions were compiled. The deformities and treatment obstacles are discussed in relation to the current literature and clinical management of hand burns.

Central monitoring deficiency and schizophrenic symptoms.

Twenty-five schizophrenic patients currently experiencing Schneiderian symptoms performed a series of tasks in which drawings had to be made in the absence of immediate visual feedback. In comparison to 10 normal controls and to 30 patients not experiencing Schneiderian symptoms, the target group had great difficulty in keeping track of their performance and remembering what actions they had made. These results are consistent with the hypothesis that Schneiderian symptoms (such as delusions of alien control) are associated with impairments in the central monitoring of action.

Lack of long-term durability of cultured keratinocyte burn-wound coverage: a case report.

Cultured epithelial autografts have been advocated for permanent closure of skin surfaces after massive thermal injuries. A 10-year-old boy sustained a nearly 100% total body surface area burn (98% full-thickness) in an explosion accident. Cultured epithelial autograft was used to cover 70% of the total body surface area on postburn day 26. In spite of early success of coverage, 60% of cultured epithelial autograft areas blistered and sloughed over the ensuing weeks. Electron microscopic examination of a biopsy specimen of the healed cultured epithelial autograft (80 days after placement) revealed a lack of dermal attachments of the anchoring fibrils. Additionally, blister fluid that was taken from the bullae of the cultured epithelial autograft revealed levels of 18 ng/ml thromboxane and 24 ng/ml prostaglandin E2. These levels are significantly higher than those seen in acute burn blister fluid and indicate an ongoing inflammatory process. Cultured keratinocytes, although they provide early wound closure, may not provide adequate long-term coverage for patients with massive burns.