Clinical Test Performance Research Articles

Focused Update on Clinical Testing of Otolith Organs.

Sensing gravity through the otolith receptors is crucial for bipedal stability and gait. The overall contribution of the otolith organs to eye movements, postural control, and perceptual functions is the basis for clinical testing of otolith function. With such a wide range of contributions, it is important to recognize that the functional outcomes of these tests may vary depending on the specific method employed to stimulate the hair cells. In this article, we review common methods used for clinical evaluation of otolith function and discuss how different aspects of physiology may affect the functional measurements in these tests. We compare the properties and performance of various clinical tests with an emphasis on the newly developed video ocular counter roll (vOCR), measurement of ocular torsion on fundus photography, and subjective visual vertical or horizontal (SVV/SVH) testing.

Cutibacterium Species Valvular and Cardiac Device-Related Infective Endocarditis: Contemporary Data From the GAMES Prospective Cohort (2008-2023).

Information on infective endocarditis (IE) caused by Cutibacterium spp. is limited and new Duke-International Society for Cardiovascular Infectious Diseases (ISCVID) criteria have not yet been properly assessed. We examined clinical characteristics, outcomes, and performance of diagnostic tests for Cutibacterium valvular and cardiac implantable electronic device-related IE (CIED-IE). Data corresponding to all episodes of Cutibacterium IE recorded from 2008 to 2023 in a prospective national cohort including 46 Spanish hospitals were examined. Possible IE cases were reassessed using the new criteria. The sensitivity of blood cultures, valvular and CIED cultures, and polymerase chain reaction of the 16S rRNA gene and sequencing (16SPCR) was evaluated. Of 6692 episodes of IE, 67 (1%) were caused by Cutibacterium spp. with 85% affecting men. Of these, 50 were valve-related (45 prosthetic, 5 native) and 17 CIED-related. The new criteria identified 8 additional cases and reclassified 15 as definite IE. Intracardiac complications (abscess, pseudoaneurysm, perforation, or intracardiac fistula) occurred in 23 of 50 (46%) valvular IE episodes, leading to 18% mortality, and up to 40% mortality if surgery was indicated but could not be performed. All CIED-IE cases underwent device removal and no deaths were recorded. Positive diagnosis rates for blood cultures, valve/device cultures, and 16SPCR were 52%, 70%, and 82%, respectively. Cutibacterium IE is a rare yet potentially life-threatening condition that warrants a high index of suspicion in men with endovascular prosthetic material. The new Duke-ISCVID criteria and molecular techniques are useful for its diagnosis. Considering a significant complication rate, cardiac surgery and removal of CIEDs play a key role in reducing mortality.

Functional clinical motor performance tests to assess potential fall risks in patients with haemophilia: A case-control study.

Patients with haemophilia (PwH) are at increased risk of falls due to haemophilic arthropathy. Yet, studies on clinical tests associated with the risk of falling are scarce in PwH. (1) To evaluate the feasibility of different clinical motor performance tests associated with the risk of falling in PwH; (2) to evaluate PwH's performance of these tests compared to a control group; (3) to identify possible influencing factors that affect performance. Twenty-nine severe and moderate PwH (57.0 years, IQR: 48.0-61.5) and 29 healthy age- and BMI-matched control participants (CG) performed 13 different clinical tests (SPPB, timed up and go, push and release, functional reach, single-leg stance, knee and grip strength). Haemophilia joint health score (HJHS), kinesiophobia (TSK-11), subjective physical performance (HEP-Test-Q), falls efficiency (FES-I) and falls were assessed. No adverse events occurred. PwH showed impaired performance in all clinical tests, a lower falls efficiency and a higher HJHS than CG. PwH with higher HJHS, lower HEP-Test-Q and higher TSK-11 scores showed higher deficits. Largest discrepancies were observed in the single-leg stance with eyes open and knee extensor strength, where orthopaedically majorly affected PwH showed worse performance compared to minorly affected PwH and the CG, respectively. The prevalence of ≥1 fall in the last year was 27.6% (PwH) and 10.3% (CG). These clinical tests are feasible in PwH. Impaired joint status, a high kinesiophobia and low physical performance impair performance. These tests can be used by clinicians for gaining specific information on functional motor abilities of patients.

ALBUMINURIA IS ASSOCIATED WITH LESS EFFORT TOLERANCE IN HYPERTENSION AND DIABETES

Introduction: The presence of albuminuria is an adverse marker of renal dysfunction progression. Hypertension and diabetes mellitus predispose to albuminuria. However, not all hypertensive and diabetic patients have albuminuria, so it is relevant to identify risk factors associated to this abnormality. The acute effect of intense physical activity may lead to transient albuminuria. On the other hand, physical inactivity is associated with risk factors for albuminuria Objective: To analyze the association between activity levels or physical performance and albuminuria in hypertensive and/or diabetic patients treated at basic health services. Methodology: A prospective cross-sectional study with hypertensives and/or diabetics subjects. The patients were evaluated in regard of albuminuria, clinical, laboratory and physical test performance variables. Results: There was no association between the degree of albuminuria and demographic, anthropometric, laboratory variables, functional capacity and level of physical activity. The degree of albuminuria was associated with systolic blood pressure, as well as the perception of effort, obtained by Borg Scale during the test in univariate analysis (odds ratio 4.11 with 95% confidence interval from 1.18 to 14.37, p = 0.027) and adjusted for systolic blood pressure and diabetes (odds ratio 3.02 with 95% confidence interval from 1.35 to 6.75; p = 0.007). Conclusion: there was association between albuminuria and perceived effort, as well with systolic blood pressure. There was not with association physical performance or level of activity. Further studies are needed to elucidate the association of albuminuria with Borg Scale.

Communication Under Sharply Degraded Auditory Input and the "2-Sentence" Problem.

Despite performing well in standard clinical assessments of speech perception, many cochlear implant (CI) users report experiencing significant difficulties when listening in real-world environments. We hypothesize that this disconnect may be related, in part, to the limited ecological validity of tests that are currently used clinically and in research laboratories. The challenges that arise from degraded auditory information provided by a CI, combined with the listener's finite cognitive resources, may lead to difficulties when processing speech material that is more demanding than the single words or single sentences that are used in clinical tests. Here, we investigate whether speech identification performance and processing effort (indexed by pupil dilation measures) are affected when CI users or normal-hearing control subjects are asked to repeat two sentences presented sequentially instead of just one sentence. Response accuracy was minimally affected in normal-hearing listeners, but CI users showed a wide range of outcomes, from no change to decrements of up to 45 percentage points. The amount of decrement was not predictable from the CI users' performance in standard clinical tests. Pupillometry measures tracked closely with task difficulty in both the CI group and the normal-hearing group, even though the latter had speech perception scores near ceiling levels for all conditions. Speech identification performance is significantly degraded in many (but not all) CI users in response to input that is only slightly more challenging than standard clinical tests; specifically, when two sentences are presented sequentially before requesting a response, instead of presenting just a single sentence at a time. This potential "2-sentence problem" represents one of the simplest possible scenarios that go beyond presentation of the single words or sentences used in most clinical tests of speech perception, and it raises the possibility that even good performers in single-sentence tests may be seriously impaired by other ecologically relevant manipulations. The present findings also raise the possibility that a clinical version of a 2-sentence test may provide actionable information for counseling and rehabilitating CI users, and for people who interact with them closely.

Characterization of Relevant Bovine Dander Allergen Components.

Diagnostic tests in occupational allergic diseases are highly dependent on the quality of available allergen extracts and specific IgE tests. To enhance diagnostic testing in cattle-related occupational rhinitis, asthma, and urticaria, we produced an in- house cow dander extract, assessed its allergen profile and performance in clinical tests, and compared it with commercial bovine dander extracts. One hundred patients with a suspected cattle-related occupational disease underwent skin prick tests (SPTs) with in-house and 1 or 2 commercial bovine dander extracts. Nasal allergen provocation tests were performed on 31 patients with suspected occupational rhinitis. We used Western blot to study the specific IgE-protein reactions from the sera of the patients with positive provocation test results and identified allergens from immunoblot bands using tandem mass spectrometry. The odorant-binding protein Bos d OBP, bovine serum albumin (Bos d 6), and the lipocalin (Bos d 2) were identified as the major allergens. We found a total of 24 bovine dander allergens, of which several were formerly unknown. The sensitivity and specificity of the in-house extract in SPTs were 100% and 94%, respectively, in 87 patients. The SPT results were negative in 20 healthy controls. Nasal allergen provocation tests with in-house extract detected occupational rhinitis with 100% sensitivity in 21 patients. The provocation results remained negative in 5 healthy controls. Three major and several minor allergens in bovine dander caused occupational rhinitis. Diagnosis of bovine allergen-related occupational diseases requires a sufficient concentration and variety of tested allergens.

Multicenter clinical validation of GutSeer: A cost-effective, blood-based assay for early detection and localization of major gastrointestinal cancers.

739 Background: Gastrointestinal (GI) cancers account for over one-third of cancer-related deaths. We have previously developed GutSeer, a non-invasive assay utilizing cell-free DNA (cfDNA) methylation and fragmentation signatures, to cost-effectively detect and localize five major GI cancers, including colorectal (CC), gastric (GC), liver (LC), esophageal (EC), and pancreatic cancer (PC). Methods: GutSeer was initially developed and validated in a large retrospective cohort of 1844 plasma samples, demonstrating excellent performance with specificity, sensitivity, and tissue of origin (TOO) accuracy at 96.7%, 86.2%, and 82%, respectively. In this study, we conducted a blind, multi-center clinical test for further validation. Participants were recruited from two centers, Beijing (BJ) and Shanghai (SH). Cohort BJ included 42 participants (20 healthy, 22 cancer), and Cohort SH comprised 403 participants (105 healthy, 123 benign, 175 cancer). Over half of the cancer samples in Cohort SH were in early-stage disease (TNM stages I and II). Results: In Cohort BJ, GutSeer showed 100% specificity, 68.2% sensitivity, and 86.7% TOO accuracy. Individual cancer type sensitivities within Cohort BJ were 100% for CC, 57.1% for EC, 75% for GC, 40% for PC, and 100% for LC. In Cohort SH, GutSeer exhibited 94.6% specificity for healthy samples and 86.2% for benign conditions. For cancer samples in Cohort SH, the overall sensitivity achieved 78.9%, with specific sensitivities of 92.3% for CC, 81.0% for EC, 78.4% for GC, 52.9% for PC, and 86.4% for LC. Moreover, GutSeer also efficiently detected early-stage cancers, with stage-wise sensitivities ranging from 64.7% (stage I) to 96.3% (stage IV). TOO accuracy in Cohort SH was 79.0%, with individual cancer types achieving accuracies from 71.7% to 94.7% (72.2% for CC, 71.7% for EC/GC, 94.7% for LC, and 77.8% for PC). Conclusions: GutSeer demonstrates promising potential as a cost-effective, non-invasive test for early detection and localization of major GI cancers. Its consistently high performance in both retrospective and multi-center blind clinical tests implies its potential to revolutionize the screening and diagnosis paradigm for GI cancers.

The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing (December 2023).

Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19) and for identifying asymptomatic carriage of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The number of available SARS-CoV-2 nucleic acid detection tests continues to increase as does the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) developed an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients, and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss nuances of test result interpretation in a variety of practice settings, and highlight important unmet research needs related to COVID-19 diagnostic testing. IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel agreed on 12 diagnostic recommendations. Access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention, and the public health response to COVID-19 infection. Information on the clinical performance of available tests continues to grow, but the quality of evidence of the current literature to support this updated molecular diagnostic guideline remains moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is suggested for asymptomatic individuals with known or suspected contact with a COVID-19 case when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions. Evidence in support of rapid testing and testing of upper respiratory specimens other than nasopharyngeal swabs, which offer logistical advantages, is sufficient to warrant conditional recommendations in favor of these approaches.

MRI white matter hyperintensities and neuropsychological performance in a clinical sample

Objective White-matter hyperintensities (WMH) are commonly observed on MRI of non-demented patients. Findings are mixed regarding their association with neuropsychological test performance. The purpose of this study is to investigate the association of white-matter hyperintensities on routine clinical MRI and neuropsychological test performance in non-demented outpatients. Method Two groups were selected based on MRI results: (1) normal (n = 62, M age = 50.21, M edu = 14.89) and (2) WMH without other MRI abnormality (n = 56, M age = 55.43, M edu = 14.04). Neuropsychological tests assessed five cognitive domains for which index scores were calculated and categorized in the following clinical ranges: well below average, below average, low average, average, and above average. Results Likelihood ratios comparing base rates for the WMH and normal groups across these clinical ranges revealed significant base rate differences only for attention/processing speed (Lχ2 = 16.47, df = 4, p < .01), with more WMH patients in the below average range and fewer above average. Odds ratios were calculated using two z-score cutoffs: −1.67 and −1.00. While patients with WMH were significantly more likely to have an index z-score ≤ −1.00 on attention/processing speed tests (OR = 3.62, 95% CI: 1.08–12.19) and an executive function test of reasoning (OR = 4.63, 95% CI: 1.18–18.19), there was no difference in the likelihood the groups would have a z-score ≤ −1.67 in any cognitive domain. Conclusions Taken together, these findings indicate that among referred outpatients without dementia, WMH on routine clinical MRI are associated with relatively mild decreased attention and processing speed.

The rate of force relaxation scaling factor is highly sensitive to detect upper and lower extremity motor deficiencies in mildly affected people with multiple sclerosis.

The motor symptoms affecting upper and lower extremity functioning in people with multiple sclerosis (PwMS) are considered the cardinal symptoms of multiple sclerosis. There is still a need for outcome measures that can sensitively evaluate these symptoms. We aimed to investigate the sensitivity of the isometric outcomes (maximum force; Fmax, maximum rate of force development; RFDmax, rate of force development scaling factor; RFD-SF, and rate of force relaxation scaling factor; RFR-SF) and standard clinical tests (9-hole peg test; 9HPT and timed 25-feet walk test; T25FW) in detecting the upper and lower extremity motor deficiencies in PwMS and also in a subgroup of mildly affected PwMS whose performance in standard clinical tests were similar to controls. Twenty-nine PwMS (age: 47.9 (8.6) years, relapsing-remitting type, expanded disability status scale: 2.5 (1.5)) and their age- and gender-matched controls completed an identical testing protocol in the upper (grip force muscles) and lower (knee extensors) extremities. For each extremity, we assessed Fmax, RFDmax, RFD-SF, and RFR-SF. Additionally, participants completed standard clinical tests for the evaluation of upper- (9HPT) and lower-extremity (T25FW) function. Comparisons were made between controls and PwMS 1) using all study participants and 2) including only mildly affected PwMS whose performance in standard functional tests was comparable to controls. Independent sample t-tests were utilized to compare groups, with a p-value set at 0.01 to correct for multiple comparisons. P-values and effect sizes were used to evaluate the sensitivity of the outcome measures in detecting group differences. Our results indicate that most isometric outcomes and standard functional tests were sensitive in detecting motor deficiencies in both upper and lower extremities between groups (p<0.001). Among participants, 16 PwMS in 9HPT and 11 PwMS in T25FW demonstrated performance similar to that of the control group (9HPT: 18.85 (2.20) s vs 17.81 (2.19) s; p=0.19) and (T25FW: 3.60 (0.42) s vs 3.58 (0.29) s; p=0.92). The results of the comparisons between mildly affected PwMS and their controls indicate that RFR-SF is the only sensitive isometric outcome to detect differences between groups in the upper (-8.24 (0.76) 1/s vs -8.93 (0.6) 1/s; p=0.008) and lower extremity (-5.86 (1.13) 1/s vs -7.71 (1.11) 1/s; p<0.001). The rate of force relaxation scaling factor, which assesses the ability to rapidly relax muscle forces after quick contractions, demonstrates high sensitivity in detecting motor deficiencies in PwMS, even when the current standard clinical outcomes fail to detect these differences. Our findings emphasize the importance of future randomized controlled trials focusing on rehabilitative and therapeutic interventions that specifically target muscle force relaxation to enhance motor functioning in PwMS.

NIS2+™, an effective blood-based test for the diagnosis of at-risk nonalcoholic steatohepatitis in adults 65 years and older.

Older patients are at increased risk for at-risk NASH, defined as NASH with NAFLD activity scores (NAS) ≥4 and significant fibrosis (F ≥ 2). The aim of this study was to compare the performance of 2 new blood tests, NIS4® and NIS2+™, with FIB-4, NFS, ELF™, and alanine aminotransferase (ALT) for the diagnosis of at-risk NASH in a cohort of patients aged ≥65 years. The clinical performance of multiple blood-based tests was assessed for their ability to detect at-risk NASH using the RESOLVE-IT diag cohort, a large population of patients with metabolic risk who were screened for potential inclusion in the RESOLVE-IT phase 3 trial. The study cohort (n = 2053) included patients with the full histological spectrum of NAFLD, with patients having liver fibrosis stages F0-4 and NAS scores 0-8. NIS4® and NIS2+™ showed similar assay performance in patients who were <65 versus ≥65 years of age (AUROC = 0.80 vs. 0.78, p = 0.47; 0.81 vs. 0.83 p = 0.45, respectively) for the identification of at-risk NASH. In patients ≥65 (n = 410), NIS2+™ exhibited the highest AUROC compared to NIS4®, FIB-4, NFS, ELF™, and ALT (AUROC = 0.83 vs. 0.78, 0.68, 0.58, 0.69, 0.74, respectively; all p ≤ 0.0009). For NIS2+™, the sensitivity and NPV for ruling-out at-risk NASH at the 0.46 cutoff were 90.2% and 86.0%, and the specificity and PPV for ruling-in at-risk NASH at the 0.68 cutoff were81.1% and 76.3%, respectively. The clinical performance of NIS2+™ was superior for the diagnosis of at-risk NASH in patients ≥65 years of age. These data support the clinical value of this blood-based test for the diagnosis of at-risk NASH in older adults.

Patients’ expectancy scale of acupuncture: Development and clinical performance test

PurposeThis study aims to develop and validate a concise tool for evaluating acupuncture expectancy that is easy to understand and conforms to acupuncture characteristics. Materials and methodsA draft was created using the Delphi consensus method. Reliability, validity, discrimination, and feasibility tests were conducted at the item and scale levels. ResultsThe scale themes were defined as disease-related, treatment-related, process-related, and outcome-related. After two rounds of Delphi surveys with good experts' reliability (authority coefficients of experts were 0.86 and 0.87 in the two rounds) and agreement (Kendall's concordance coefficient of the participants were 0.33 and 0.15 in the two rounds, P < 0.05), 11 items (the mean score for item importance, full mark ratios, and coefficient of variation of items were ≥3.5, ≥25%, and ≤0.30, respectively) were included in the draft. A total of 145 individuals were recruited to test the draft. Reliability was assessed by Cronbach's α coefficient (0.90), split-half reliability coefficient (0.89), and test–retest reliability (Pearson's coefficient = 0.74, P < 0.05). Content validity was assessed by the content validity index (Item-CVI ≥ 0.78 and Scale-CVI/Ave = 0.92), and a confirmatory factor analysis was performed to assess the construct validity. The discrimination of scale items was evaluated by the critical ratio (CR > 3.00) and the homogeneity test (item-total correlations >0.40). Feasibility was assessed through the acceptance rate (recovery rate = 98.60%, response rate = 100%), completion rate (100%), and completion time (4.99 ± 6.80 min). ConclusionThe patients’ expectancy scale of acupuncture (PESA) consists of 11 items with four themes, disease-related, treatment-related, process-related, and outcome-related. It has great reliability, validity, discrimination, and feasibility and has the potential to evaluate acupuncture expectancy in clinical trials.

Standard versus innovative robotic balance assessment for people with multiple sclerosis: a correlational study

IntroductionBalance disorders are common in people with Multiple Sclerosis (PwMS) and, together with other impairments and disabilities, often prevent PwMS from performing their daily living activities. Besides clinical scales and performance tests, robotic platforms can provide more sensitive, specific, and objective monitoring. Validated technologies have been adopted as gold standard, but innovative robotic solutions would represent an opportunity to detect balance impairment in PwMS.AimStudy’s aim was to compare postural assessment of 46 PwMS with a relapsing–remitting form during static tasks performed with the novel robotic platform hunova® and the gold standard EquiTest®,MethodsPearson’s r was run on Center of Pressure (COP)-related parameters and global static balance measures computed from hunova® and EquiTest® in eyes-open (EO) and eyes-closed (EC) conditions. In addition, agreeableness level toward the use of both devices was tested through numeric rating scale.ResultsConsidering COP-related parameters, correlations were significant for all measures (p < .001). Interestingly, in EO, a strong correlation was shown for sway area (r = .770), while Medio-Lateral (ML) and Anterior–Posterior (AP) oscillation range, path length, ML and AP speed, ML and AP root mean square distance had a relatively strong association (.454 ≤ r ≤ .576). In EC, except for ML oscillation range showing a relatively strong correlation (r = .532), other parameters were strongly associated (.603 ≤ r ≤ .782). Correlations between global balance indexes of hunova® and EquiTest® revealed a relatively strong association between the Somatosensory Score in EquiTest® and the Somatosensory Index in hunova® (r = − .488). While in EO Static Balance Index from hunova® was highly correlated with Equilibrium score of EquiTest® (r = .416), Static Balance Index had a relatively strong association with both the Equilibrium (r = .482) and Strategy Score (r = .583) of EquiTest® in EC. Results from agreeableness rating scale revealed that hunova® was highly appreciated compared to EquiTest® (p = .044).Conclusionshunova® represents an innovative adjunct to standard robotic balance evaluation for PwMS. This confirms that combining traditional and robotic assessments can more accurately detect balance impairments in MS.

Antigen concentration, viral load, and test performance for SARS-CoV-2 in multiple specimen types.

The relationship between N-antigen concentration and viral load within and across different specimens guides the clinical performance of rapid diagnostic tests (RDT) in different uses. A prospective study was conducted in Porto Velho, Brazil, to investigate RDT performance in different specimen types as a function of the correlation between antigen concentration and viral load. The study included 214 close contacts with recent exposures to confirmed cases, aged 12 years and older and with various levels of vaccination. Antigen concentration was measured in nasopharyngeal swab (NPS), anterior nares swab (ANS), and saliva specimens. Reverse transcriptase (RT)-PCR was conducted on the NPS and saliva specimens, and two RDTs were conducted on ANS and one RDT on saliva. Antigen concentration correlated well with viral load when measured in the same specimen type but not across specimen types. Antigen levels were higher in symptomatic cases compared to asymptomatic/oligosymptomatic cases and lower in saliva compared to NPS and ANS samples. Discordant results between the RDTs conducted on ANS and the RT-PCR on NPS were resolved by antigen concentration values. The analytical limit-of-detection of RDTs can be used to predict the performance of the tests in populations for which the antigen concentration is known. The antigen dynamics across different sample types observed in SARS-CoV-2 disease progression support use of RDTs with nasal samples. Given lower antigen concentrations in saliva, rapid testing using saliva is expected to require improved RDT analytical sensitivity to achieve clinical sensitivity similar to rapid testing of nasal samples.

Myofascial stiffness of plantar fascia and Achilles tendon in individuals with plantar fasciopathy: An observational cross-sectional study

BackgroundAssessment of myofascial tissue stiffness have a role in identifying physical impairments in plantar fasciopathy (PF). It is still unclear which specific functional and tissue differences exist between individuals with PF. AimTo compare myofascial stiffness of plantar fascia, Achilles tendon, and triceps surae between symptomatic and asymptomatic limbs in individuals with PF and between individuals with and without PF. MethodsThirty nine individuals diagnosed with PF and individuals with no history of PF were recruited. Myofascial stiffness of the plantar fascia, Achilles tendon, and triceps surae, range of motion, and clinical tests were performed. Mean difference (MD) and 95% confidence interval (CI) were calculated. ResultsIndividuals with PF showed lower mean stiffness in Achilles tendon insertion (MD = −1.00 N/mm; 95%CI: -1.80,-0.21) on the symptomatic limb compared to the corresponding symptomatic limb in control group, a lower mean stiffness in plantar fascia (MD = −0.16 N/mm; 95%CI: -0.30, −0.01) on the symptomatic limb compared to asymptomatic limb, and a lower mean stiffness in the region 3 cm above the Achilles tendon insertion (MD = −0.79; 95%CI: -1.59, −0.00) compared to control. Individuals with PF showed fewer repetitions in heel rise test (MD = −3.97 reps; 95%CI: -5.83, −2.12) and in the step-down test (MD = −5.23 reps; 95%CI: -7.02, −3.44) compared to control. ConclusionsIndividuals with PF present reduced stiffness in Achilles tendon insertion and plantar fascia. The reduced stiffness was more evident in Achilles tendon in individuals with PF compared to individuals without PF. Individuals with PF showed lower performance in clinical tests.

Utility of Extended HPV Genotyping as Primary Cervical Screen in an Unscreened Population With High HIV Co-Infection Rate.

Screening with primary human papillomavirus (HPV) testing has been evaluated in highly prescreened populations with lower HPV and HIV prevalence than what is the case in South Africa. High prevalence of HPV and underlying precancer in women living with HIV (WLWH) affect the clinical performance of screening tests significantly. This study investigates the utility and performance of an extended genotyping HPV test in detection of precancer in a population with a high coinfection rate with HIV. A total of 1,001 women aged 25 to 65 years with no cervical cancer screening in the preceding 5 years were tested with cytology and primary extended genotyping HPV testing. The cohort of 1,001 women included 430 WLWH (43.0%) and 564 HIV-negative (56.3%) women. Abnormal cytology (atypical squamous cells of undetermined significance or higher) was significantly higher in WLWH (37.2% vs 15.9%) and high-grade squamous intraepithelial lesion or above (23.5% vs 5.2%). The WLWH also tested positive more often for any HPV type (44.3% vs 19.6%; p < .0001) The specificity for cervical intraepithelial neoplasia 2+ at 91.2% of a combination of HPV types, 16/18/45 (very high risk) and 31/33/58/52 (moderate risk), performed better than cytology or any HPV-positive result to predict cervical intraepithelial neoplasia 3+ on histology. The additional genotype information supports direct referral to treatment or colposcopy in a larger proportion of the screen-positive population. The potential contribution of extended genotyping is demonstrated. The ideal choice of sensitivity and specificity ultimately depends on the health budget. More information will allow a screening algorithm, guiding management according to risk.

Sustained attention performance deficits in the three-choice serial reaction time task in male and female rats after experimental brain trauma

Impaired attention is central to the cognitive deficits associated with long-term sequelae for many traumatic brain injury (TBI) survivors. Assessing complex sustained attention post-TBI is clinically-relevant and may provide reliable avenues towards developing therapeutic and rehabilitation targets in both males and females. We hypothesized that rats subjected to a moderate TBI will exhibit attentional deficits seen as reduced accuracy and increased distractibility in an operant 3-choice serial reaction time task (3-CSRT), designed as an analogue of the clinical continuous performance test. Upon reaching baseline of 70% accuracy at the 300 ms cue, adult male and female Sprague-Dawley rats were subjected to a controlled cortical impact (2.8 mm deformation at 4 m/s) or sham injury over the right parietal cortex. After two weeks of recovery, they were retested on the 3-CSRT for ten days. Dependent measures include percent accuracy (overall and for each of the three cue ports), percent omissions, as well as latency to instrumental poke and retrieve reward. Results demonstrate that both males and females displayed reduced percent accuracy and increased omissions when re-tested post-TBI on 3-CSRT compared to Sham rats and to their own pre-insult baseline (p’s < 0.05). Performance accuracy was impaired consistently throughout the ten days of post-surgery re-testing, suggesting pronounced and long-lasting dysfunction in sustained attention processes. Deficits were specifically more pronounced when the cue was pseudorandomly presented in the left-side cue port (p < 0.05), mirroring clinical hemispatial neglect. These data demonstrate significant and persistent complex attention impairments in both sexes after TBI, rendering identifying efficient therapies for cognitive recovery as pivotal.

Clinical performance of rapid antigen tests in comparison to RT-PCR for SARS-COV-2 diagnosis in Omicron variant: Asystematic review and meta-analysis.

The Omicron variant of concern has a high level of mutations in different genes that has raised awareness about the performance of immunological products such as vaccines and antigen detection kits. In this systematic review and meta-analysis, we investigated whether Omicron had a significant influence on rapid antigen test (RAT) performance in comparison to PCR. We registered this systematic review and meta-analysis in PROSPERO with the registration number CRD42022355510. We searched PubMed, Scopus, Embase, and Web of Science databases systematically to 1 August 2022. After article screening, we assessed the quality of the included studies based on the JBI checklist. Following data extraction, we performed a meta-analysis using R software. We included 18 qualified articles presenting sufficient data about RATs performance in comparison to RT-PCR in Omicron infections. The pooled specificity and sensitivity of RATs were 1.000 (0.997-1.000) and 0.671 (0.595-0.721), respectively. The FDA-approved kits showed a better performance than WHO-approved ones with a sensitivity of 0.728 (0.620-0.815). The use of RATs with nasal swabs showed a higher sensitivity compared with nasopharyngeal swabs. The sensitivity for samples with a CT-value >25 was 0.108 (0.048-0.227). Rapid antigen tests show impaired performance for COVID-19 diagnosis when the Omicron variant is circulating, particularly in samples with low viral loads.

Effects of Oral Levodopa on Balance in People with Idiopathic Parkinson's Disease.

Balance impairment is a frequent cause of morbidity and mortality in people with Parkinson's disease (PD). As opposed to the effects of appendicular motor symptoms, the effects of Levodopa on balance impairment in idiopathic PD are less clear. To review the literature on the effects of oral Levodopa on clinical balance test performance, posturography, step initiation, and responses to perturbation in people with idiopathic PD (PwPD). A systematic search of three scientific databases (Pubmed, Embase, and Web of Science) was conducted in accordance with PRISMA guidelines. For the pilot meta-analysis, standardized mean differences with 95% confidence intervals were calculated using an inverse variance random effects model. Data not suitable for implementation in the meta-analysis (missing means or standard deviations, and non-independent outcomes) were analyzed narratively. A total of 2772 unique studies were retrieved, of which 18 met the eligibility criteria and were analyzed, including data of 710 idiopathic PwPD. Levodopa had a significant positive effect on the Berg Balance Scale, the Push and Release test, and jerk and frequency parameters during posturography. In contrast, some significant negative effects on velocity-based sway parameters were found during posturography and step initiation. However, Levodopa had no significant effect on most step initiation- and all perturbation parameters. The effects of Levodopa on balance in PwPD vary depending on the outcome parameters and patient inclusion criteria. A systematic approach with well-defined outcome parameters, and prespecified, sensitive and reliable tests is needed in future studies to unravel the effects of oral Levodopa on balance.

Differential clinical characteristics and performance of home antigen tests between parents and children after household transmission of SARS-CoV-2 during the Omicron variant pandemic

ObjectivesThe SARS-CoV-2 Omicron variant pandemic struck Taiwan in April 2022. Rapid antigen tests (RATs) play an important role in providing rapid results during a pandemic. However, self-collected samples by the children's caregivers without the supervision of medical personnel raise some concerns. MethodsThis study was performed to investigate household transmission, clinical characteristics, and antigen performance in a special COVID-19 family clinic in a children's hospital. The performance of at-home RATs was evaluated based on reverse transcription-polymerase chain reaction. ResultsWe included 627 patients in our study between May 11 and June 10, 2022. The COVID-19 full vaccination rate was significantly higher in adults (98.5%) than in children (5.9%, P <0.001). The transmission rate was significantly higher in children (91.3%) than in adults (76.6%, P <0.001). Infected children had more incidents of fever (82.4% vs 22.4%, P <0.001) and a higher peak fever than adults. Based on the reverse transcription-polymerase chain reaction, the negative predictive rate of the home RAT was only 38.7% (95% confidence interval: 31.9-46.0%) in children. The cycle threshold value of those with false-negative antigen tests was significantly lower in children. ConclusionChildren had a higher transmission rate, more fever, and higher peak fever than adults. Home RAT has a suboptimal negative predictive rate in children.