Clinical Screening Tests Research Articles

Validity & Reliability of a Korean-version of Eating Assessment Tool (K-EAT-10): Predicting the Risk of Aspiration in Stroke Patients

Objectives: This study aims to investigate the reliability and validity of a Korean version of the Eating Assessment Tool (EAT-10) as a clinical evaluation tool for dysphagia with stroke patients and determine its clinical usefulness as a screening tool. Methods: A total of 50 patients with stroke (15 without dysphagia, and 35 with dysphagia, identified through a videofluoroscopic swallowing study (VFSS) participated in this study. The internal consistency, test-retest reliability, and concurrent validity of the adapted Korean version of EAT-10(K-EAT-10) were evaluated. In addition, the K- EAT-10 scores were compared between two groups according to demographic characteristics, post-stroke conditions, and swallowing function. Moreover, K-EAT-10 scores were compared with the VFSS findings to estimate the sensitivity, specificity, and positive and negative predictions of aspiration. Results: The internal consistency of the K-EAT-10 questionnaire showed a Cronbach α coefficient of .091, and the correlation coefficient of the test- retest reliability was .988. In addition, when correlation analysis was performed between the total score of K-EAT-10 and the K-DHI, the correlation coefficient was .904. In the receiver operating characteristic (ROC) curve analysis of K-EAT-10, a cut-off point for the K-EAT-10 questionnaire was set at 10 points with a sensitivity of 86.7% and specificity of 77.1%, and the area under the curve was shown to be 0.86. In addition, the positive predictive value (PPV) for the K-EAT-10 was 91%, and the negative predictive value (NPV) was 60%. Conclusion: Korean version of EAT-10 revealed excellent internal consistency, test-retest reliability, concurrent validity and positive predictive value for aspiration. The results suggest that the Korean adaptation of EAT-10 can be useful as a clinical screening test for dysphagia, especially predicting aspiration risk in patients with stroke.

Different perspectives on translational genomics in personalized medicine

Personalized medicine is a relatively new and interesting concept in the medical and healthcare industries. New approaches in current research have supported the search for biomarkers, based on the genomic, epigenomic and proteomic profile of individuals, using new technological tools. This perspective involves the potential to determine optimal medical interventions and provide the optimal benefit-risk balance for treatment, whilst it also takes a patient's personal situation into consideration. Translational genomics, a subfield of personalized medicine, is changing medical practice, by facilitating clinical or non-clinical screening tests, informing diagnoses and therapeutics, and routinely offering personalized health-risk assessments and personalized treatments. Further research into translational genomics will play a critical role in creating a new approach to cancer, pharmacogenomics, and women's health. Our current knowledge may be used to develop new solutions that can be used to minimize, improve, manage, and delay the symptoms of diseases in real-time and maintain a healthy lifestyle. In this review, we define and discuss the current status of translational genomics in some special areas including integration into research and health care.

Fiberoptic endoscopic validation of a clinical screening test of swallowing function in critically ill patients performed within 24 h after extubation

BackgroundA bedside screening tool of swallowing dysfunction (SD) (BSSD) after extubation would be useful to identify patients who are at risk of SD. We aimed to evaluate the accuracy of our BSSD in comparison with fiberoptic endoscopic evaluation of swallowing (FEES) in critically ill patients after extubation. MethodsWe conducted a 1-year prospective monocentric study to evaluate the accuracy of our BSSD to diagnose SD following endotracheal intubation in comparison with FEES (gold standard). Patients intubated for longer than 48 h were included. Both tests were assessed within 24 h after extubation. Primary endpoint was the accuracy of the BSSD. Secondary endpoint was to assess risk factors of SD. ResultsSeventy-nine patients were included in the study. Thirty-three patients (42%) presented with a SD. The BSSD showed a sensitivity of 88% (95% CI 0.72–0.97) and a specificity of 91% (95% CI 0.79–0.98), a positive predictive value of 88% (95% CI 0.72–0.97) and a negative predictive value of 91% (95% CI 0.79–0.97). The AUC reached 0.83 (95% CI 0.74–0.92). ConclusionOur study describes an accurate clinical screening tool to detect SD after extubation in critically ill patients. Screening-positive cases should be confirmed by instrumental tests, ideally using FEES.

Abstract 2241: Evaluating anal cancer screening approaches in high-risk populations in Puerto Rico

Abstract Introduction: Anal cancer incidence has been rising rapidly in Puerto Rico. The ANCHOR study showed that treating high-grade squamous intraepithelial lesions (HSILs) significantly reduces anal cancer incidence. Limited research has been done to understand the validity and associated costs of screening tools used to detect anal lesions in Hispanic populations. We aimed to evaluate the clinical performance (sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) and screening test costs in the clinic-based sample. Understanding the accuracy and costs of screening tools can guide interventions in resource-limited settings to broaden the availability of effective, low-cost screening options and promote anal cancer prevention. Methods: The cross-sectionally analyzed data was collected (May 2015 - June 2021) by the Anal Neoplasia Clinic of the University of Puerto Rico Comprehensive Cancer Center. The clinic predominantly serves referred adults (≥18 years old). Patients were included in the analyses if they had complete results for anal cytology, high-resolution anoscopy (HRA) with biopsy, and anal high-risk HPV (HR-HPV) typing (n=436). Sensitivity, specificity, PPV, and NPV were estimated to evaluate the clinical performance of anal cytology alone and in combination with HR-HPV typing in the detection of histologically confirmed anal HSIL (Gold standard). Analyses were stratified by risk group (women, MSM, and heterosexual men) and HIV status. Evaluation of cost-effective alternative screening strategies is currently ongoing. Results: The mean age of our sample was 44 ± 13 years; more than half (67%) were male. HIV-infected MSM, HIV-infected women, and HIV-negative MSM comprised 45.4%, 22.2%, 13.3% of our sample, respectively. 40% of the sample had HSIL and 69% tested positive for HR-HPV. Measured against the gold standard, we found that co-testing (anal cytology and HR-HPV typing) increased the sensitivity in the groups evaluated and decreased specificity in some. Among HIV-infected MSM, the sensitivity of anal cytology alone to detect HSIL was 84.7%, whereas specificity was 30.0%. Although the sensitivity of the 2 tests combined (anal cytology and HR-HPV typing) to detect histologically confirmed HSIL increased (91.8%), the specificity decreased (22.0%). Overall, the sensitivity of cytology alone was higher in women compared to men and among PLWH compared to HIV-negative individuals. Conclusion: While higher sensitivity for HSIL detection was seen for cytology alone for women and HIV-infected populations, co-testing increased the sensitivity for HSILs detection. Understanding the accuracy and cost of screening tools can guide interventions to broaden the availability of effective, low-cost screening options and promote anal cancer prevention. Access and availability of these tools in a wide context of communities must be considered. Citation Format: Kandyce G. Keller, Celeste Leigh Pearce, Karen J. Ortiz-Ortiz, Jeslie M. Ramos-Cartagena, Humberto Guiot, Vivian Colón-López, Ashish A. Deshmukh, Maribel Tirado-Gómez, Ana Patricia Ortiz. Evaluating anal cancer screening approaches in high-risk populations in Puerto Rico [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 2241.

A RE-AIM Framework Analysis of DNA-Based Population Screening: Using Implementation Science to Translate Research Into Practice in a Healthcare System.

Introduction: DNA-based population screening has been proposed as a public health solution to identify individuals at risk for serious health conditions who otherwise may not present for medical care. The clinical utility and public health impact of DNA-based population screening is a subject of active investigation. Geisinger, an integrated healthcare delivery system, was one of the first healthcare systems to implement DNA screening programs (MyCode Community Health Initiative (MyCode) and clinical DNA screening pilot) that leverage exome data to identify individuals at risk for developing conditions with potential clinical actionability. Here, we demonstrate the use of an implementation science framework, RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance), to conduct a post-hoc evaluation and report outcomes from these two programs to inform the potential impact of DNA-based population screening. Methods: Reach and Effectiveness outcomes were determined from the MyCode research program, while Adoption and Implementation outcomes were measured using the clinical DNA screening pilot. Reach was defined as the number of patients who were offered and consented to participate in MyCode. Effectiveness of DNA screening was measured by reviewing MyCode program publications and synthesizing findings from themes. Adoption was measured by the total number of DNA screening tests ordered by clinicians at the clinical pilot sites. Implementation was assessed by interviewing a subset of clinical pilot clinicians about the deployment of and recommended adaptations to the pilot that could inform future program dissemination. Results: Reach: As of August 2020, 68% (215,078/316,612) of individuals approached to participate in the MyCode program consented. Effectiveness: Published evidence reported from MyCode demonstrates that DNA screening identifies at-risk individuals more comprehensively than clinical ascertainment based on phenotypes or personal/family history. Adoption: From July 2018 to June 2021, a total of 1,026 clinical DNA screening tests were ordered by 60 clinicians across the three pilot clinic sites. Implementation: Interviews with 14 clinicians practicing at the pilot clinic sites revealed motivation to provide patients with DNA screening results and yielded future implementation strategies. Conclusion: The RE-AIM framework offers a pragmatic solution to organize, analyze, and report outcomes across differently resourced and designed precision health programs that include genomic sequencing and return of clinically actionable genomic information.

Detection of ovarian cancer via the spectral fingerprinting of quantum-defect-modified carbon nanotubes in serum by machine learning.

Serum biomarkers are often insufficiently sensitive or specific to facilitate cancer screening or diagnostic testing. In ovarian cancer, the few established serum biomarkers are highly specific, yet insufficiently sensitive to detect early-stage disease and to impact the mortality rates of patients with this cancer. Here we show that a 'disease fingerprint' acquired via machine learning from the spectra of near-infrared fluorescence emissions of an array of carbon nanotubes functionalized with quantum defects detects high-grade serous ovarian carcinoma in serum samples from symptomatic individuals with 87% sensitivity at 98% specificity (compared with 84% sensitivity at 98% specificity for the current best clinical screening test, which uses measurements of cancer antigen 125 and transvaginal ultrasonography). We used 269 serum samples to train and validate several machine-learning classifiers for the discrimination of patients with ovarian cancer from those with other diseases and from healthy individuals. The predictive values of the best classifier could not be attained via known protein biomarkers, suggesting that the array of nanotube sensors responds to unidentified serum biomarkers.

Multi-Parametric Magnetic Resonance Imaging-Based Radiomics Analysis of Cervical Cancer for Preoperative Prediction of Lymphovascular Space Invasion.

BackgroundDetection of lymphovascular space invasion (LVSI) in early cervical cancer (CC) is challenging. To date, no standard clinical markers or screening tests have been used to detect LVSI preoperatively. Therefore, non-invasive risk stratification tools are highly desirable.ObjectiveTo train and validate a multi-parametric magnetic resonance imaging (mpMRI)-based radiomics model to detect LVSI in patients with CC and investigate its potential as a complementary tool to enhance the efficiency of risk assessment strategies.Materials and MethodsThe model was developed from the tumor volume of interest (VOI) of 125 patients with CC. A total of 1037 radiomics features obtained from conventional magnetic resonance imaging (MRI), including a small field-of-view (sFOV) high-resolution (HR)-T2-weighted MRI (T2WI), apparent diffusion coefficient (ADC), T2WI, fat-suppressed (FS)-T2WI, as well as axial and sagittal contrast-enhanced T1-weighted MRI (T1c). We conducted a radiomics-based characterization of each tumor region using pretreatment image data. Feature selection was performed using the least absolute shrinkage and selection operator method on the training set. The predictive performance was compared with single variates (clinical data and single-layer radiomics signatures) analyzed using a receiver operating characteristic (ROC) curve. Three-fold cross-validation performed 20 times was used to evaluate the accuracy of the trained classifiers and the stability of the selected features. The models were validated by using a validation set.ResultsFeature selection extracted the six most important features (3 from sFOV HR-T2WI, 1 T2WI, 1 FS-T2WI, and 1 T1c) for model construction. The mpMRI-combined radiomics model (area under the curve [AUC]: 0.940) reached a significantly higher performance (better than the clinical parameters [AUC: 0.730]), including any single-layer model using sFOV HR-T2WI (AUC: 0.840), T2WI (AUC: 0.770), FS-T2WI (AUC: 0.710), ADC maps (AUC: 0.650), sagittal, and axial T1c values (AUC: 0.710, 0.680) in the validation set.ConclusionBiomarkers using multi-parametric radiomics features derived from preoperative MR images could predict LVSI in patients with CC.

Predicting preeclampsia and related risk factors using data mining approaches: A cross-sectional study.

BackgroundPreeclampsia is a type of pregnancy hypertension disorder that has adverse effects on both the mother and the fetus. Despite recent advances in the etiology of preeclampsia, no adequate clinical screening tests have been identified to diagnose the disorder.ObjectiveWe aimed to provide a model based on data mining approaches that can be used as a screening tool to identify patients with this syndrome and also to identify the risk factors associated with it.Materials and MethodsThe data used to perform this cross-sectional study were extracted from the clinical records of 726 mothers with preeclampsia and 726 mothers without preeclampsia who were referred to Fatemieh Hospital in Hamadan City during April 2005–March 2015. In this study, six data mining methods were adopted, including logistic regression, k-nearest neighborhood, C5.0 decision tree, discriminant analysis, random forest, and support vector machine, and their performance was compared using the criteria of accuracy, sensitivity, and specificity.ResultsUnderlying condition, age, pregnancy season and the number of pregnancies were the most important risk factors for diagnosing preeclampsia. The accuracy of the models were as follows: logistic regression (0.713), k-nearest neighborhood (0.742), C5.0 decision tree (0.788), discriminant analysis (0.687), random forest (0.758) and support vector machine (0.791).ConclusionAmong the data mining methods employed in this study, support vector machine was the most accurate in predicting preeclampsia. Therefore, this model can be considered as a screening tool to diagnose this disorder.

Standard Clinical Screening Tests, Sural Radial Amplitude Ratio and F Wave Latency Compared to Conventional Nerve Conduction Studies in the Assessment of Sensorimotor Polyneuropathy in Patients with Type 2 Diabetes Mellitus.

Background and Aims:The measuring tools used for assessment of neuropathy include various questionnaires, monofilament testing, Biothesiometry and the gold standard test, nerve conduction studies (NCS). This study aims to evaluate the diagnostic accuracies of Michigan Neuropathy Screening Instrument (MNSI), Biothesiometry, Semmes Weinstein Monofilament (SWMF), Sural Radial Amplitude Ratio (SRAR) and minimal F wave latency as compared to conventional NCS and arrive at a simple diagnostic algorithm for early detection of Diabetic Peripheral Neuropathy (DPN).Methods:In a cross-sectional observational study on 48 Type 2 diabetes mellitus patients, MNSI, Biothesiometry, SWMF and NCS including F waves and SRAR were done and diagnostic accuracies (sensitivity, specificity, positive and negative predictive values) calculated taking NCS as gold standard.Results:MNSI, Biothesiometry, SWMF, SRAR and minimal F wave latency had a sensitivity of 64.3%, 78.6%, 14.3%, 100% and 78.6% and specificity of 67.7%, 52.9%, 94.1%, 23.53% and 76.47% respectively, with reference to NCS. Based on combined sensitivities and specificities, we arrived at a simple algorithm for early diagnosis of DPN, which showed that DPN could either be diagnosed or ruled out in 75% of the patients by a combination of the Biothesiometry, SRAR and left lower limb minimal F wave latency results.Conclusions:In the setting of an outpatient, multidisciplinary diabetic clinic, simple tests such as questionnaires, monofilament testing and biosthesiometer could be performed with greater ease while considering NCS as the gold standard. This algorithm, combining Biothesiometry, SRAR and left lower limb minimal F wave latency would be less time consuming and help in early diagnosis of DPN.

Diagnostic value of a vision-based intelligent gait analyzer in screening for gait abnormalities

BackgroundEarly detection of gait abnormalities is critical for preventing severe injuries in future falls. The timed up and go (TUG) test is a commonly used clinical gait screening test; however, the interpretation of its results is limited to the TUG total time. Research questionWhat is diagnostic accuracy of the low-cost, markerless, automated gait analyzer, with the aid of vision-based artificial intelligence technology, which extract gait spatiotemporal features and screen for abnormal walking patterns through video recordings of the TUG test? MethodsOur dataset contained retrospective data from outpatients from the Department of Neurology or Rehabilitation of two tertiary hospitals in Shanghai. A panel of three expert neurologists specialized in movement disorders reviewed the gait performance in each TUG video, and labeled them separately, with the most commonly assigned label being used as the reference standard. The gait analyzer performed the AlphaPose algorithm to track the human joint position and calculated the spatiotemporal parameters by filtering and double-threshold signal detection. Gait spatiotemporal features and expert labels were input into machine learning models, and the accuracy of each model was tested with leave-one-out cross-validation (LOOCV). ResultsA total of 284 participants were recruited. Among these, 100 were labeled as having abnormal gait performance by experts. The Naive Bayes classifier achieved the best performance with a full-data accuracy of 90.14% and a LOOCV accuracy of 89.08% for screening abnormal gait performance. SignificanceThis study is the first to investigate the accuracy of a vision-based intelligent gait analyzer for screening abnormal clinical gait performance. By virtue of a pose estimation algorithm and machine learning models, our intelligent gait analyzer can detect abnormal walking patterns approximate to judgements made by experienced neurologists, which is expected to be a supplementary gait assessment protocol for basic-level doctors in the future.

Interobserver and Intra-Observer Reliability of Eyelid Tests for Ocular Myasthenia Gravis.

Lid fatigability test (LFT), Cogan lid twitch (CLT), and forced eyelids closure test (FECT) are simple clinical screening tests for ocular myasthenia gravis (OMG). However, these tests are subjectively interpreted. We thus evaluated the interobserver and intra-observer reliability of each test. The 3 eyelid tests were performed in ptotic patients associated with various conditions, including OMG and others. Video clips of all tests were recorded using smartphone with built-in camera in the following order; LFT, CLT, and FECT. All video clips were distributed to 3 neuro-ophthalmologists and 3 general ophthalmologists, who were trained to evaluate the tests using a single standard instruction. After 3 months, all video clips were re-organized for the second evaluation. Interobserver and intra-observer reliability were calculated using Cohens' Kappa coefficient and Fleiss Kappa statistic. The 3 eyelid tests were performed and recorded in 35 patients, which included the diagnosis of OMG, levator muscle dehiscence, partial oculomotor nerve palsy, and Horner syndrome. CLT received moderate-to-substantial interobserver reliability in neuro-ophthalmologist group (Fleiss Kappa 0.77 [95% CI 0.60-0.94] and 0.66 [95% CI 0.46-0.85] in first and second evaluation respectively), but the results varied in general ophthalmologist group (Fleiss Kappa 0.58 [95% CI 0.37-0.79] and 0.54 [95% CI 0.33-0.76] in first and second evaluation respectively). FECT and LFT received lower interobserver reliability in both groups. CLT also received moderate-to-almost perfect intra-observer reliability in neuro-ophthalmologist group (Cohen Kappa 0.55, 0.58, and 0.92), whereas FECT and LFT received lower intra-observer reliability. The intra-observer reliability varied among general ophthalmologists for all 3 eyelid tests. CLT is the most reliable test among the 3 eyelid tests. However, all tests should be interpreted with caution by general ophthalmologists.

Practice Essentials of Imaging in Early Diagnosis of DDH.

Developmental dysplasia of hip joint (DDH) is a dynamic progressive pathology which can tilt either way. The term strictly applies to primary dysplasia, where etiology is not clearly known. Secondary dysplasia can be due multiple causes, such as neuromuscular disorders, connective tissue disorders or skeletal syndromes. The etiology being multifactorial, it needs a multidisciplinary team to address the issue at hand. The management starts antenatally with a detailed history of any risk factors and a dedicated ultrasound of the foetus, since forewarned is forearmed. At birth, a paediatrician having a keen sense of DDH will perform Barlow's or Ortolani's manoeuvre and can be the first one to sound the alarm in the event of positive findings. How and when a Radiologist needs to step in will depend on inter-departmental discussions between the paediatrician and the orthopedician. In the presence of positive clinical screening tests, and non-availability of ultrasound, a preliminary X ray pelvis AP view including both hip joints should be the requisitioned in a child of any age, particularly, if belonging to the high-risk group. If ultrasound is available, a screening exam till 6months of age is recommended to rule out DDH. India is known for its vast numbers and little babies with occult diseases are the first to bear the brunt of conditions which have very few symptoms to start with. DDH is one such condition which most unfortunately expresses itself as a symptom only when it's too late, i.e., most often when the child begins to walk. Ultrasound is the modality of choice in neonates; however, since India is a country of modest means, in majority of the regions, radiographs still remain the first line of investigation.

Mitigating the impact of SARS-CoV-2 on residential facilities for persons with intellectual disability and/or autism spectrum disorder: two experiences from the Italian red zone

Purpose Persons with intellectual disability and/or low-functioning autism spectrum didorder are with high support need (ID/ASD-HSN) are among the people who are most vulnerable to the COVID-19 pandemic. The specific vulnerability and the protective factors for persons with ID/LF-ASD attending residential and rehabilitative facilities have however received little attention. This paper aims to describe how two facilities located in the Italian COVID-19 red zone faced the risks associated with the spread of the pandemic and the results they have achieved so far. Design/methodology/approach Interventions to contrast the spread of the pandemic and preserve clients’ health conditions have been systematically monitored and recorded since the very beginning of the pandemic. Findings 26/138 clients had to undergo clinical screening and laboratory tests for COVID-like symptomatology, but only one resulted affected by COVID-19 and survived. Considering that Lombardy had 89,595 cases and 16,262 deaths (January–May 2020), one COVID-19 case/138 clients is a good result. Temporarily limiting physical contacts with friends/family in favor of reducing the burden of risk and adopting a system of prevention/safety strategies directed for persons with ID/LF-ASD attending and their caregivers have been useful measures. Research limitations/implications Structured or semi-structured interviews (using professional caregivers as informant) to confirm behavioral and emotional changes in the clients could not be carried out because of lack of time and resources (which were captured by the management of the pandemic) and could be the next goal for our residential facilities to implement the management of epidemic acute phases in a research-oriented view. Originality/value This study is a service evaluation report about facing COVID-19 pandemic. Only few such studies are present in medical literature about ID/ASD.

Review of crystallization processes applied for diagnosis and homeopathic research

Background: The present study makes part of the project ‘Systematic Review of Crystallization Processes Applied for Medical Purposes (SyRCrysMed)’. SyRCrysMed is planned to lead to a publication of three review articles: (i) on crystallization of blood and its derivatives (serum, plasma) for diagnostic purposes, (ii) on crystallization of other biological fluids for diagnostic purposes, and (iii) on crystallization applied to homeopathy (both, basic and clinical research). 
 Medical crystallization is a wide, however fragmented and little known field of science. It embraces different crystallization methodologies and applications. The commune scope of most of the crystallization-based methods is to access a more complex (or different) kind of information on the diagnosed/analyzed subject than it is possible by the use of conventional methods. The underlying thought to this analysis possibility provided by crystallization is that crystallization is an extremely sensitive process and is able to visualize not only the material dimension of the sample (e.g. composition), but also immaterial forces (e.g. force-like effects, sample’s vitality). This sensitivity of crystallization encouraged some researchers (both in the past and nowadays) to apply this process also in homeopathic research. Here we present a first summary of the crystallization-based methodologies with focus on these applied in homeopathy. 
 
 Materials and methods: 177 articles, books, and book chapters on medical crystallization have been collected from scientific databases, university libraries, and the library at the Goetheanum in Dornach/Switzerland. The collected literature was divided into experimental studies and other literature. All methodologies described in the experimental studies were summarized in accordance to following criteria: type of the biological fluid, dilution degree of the fluid in the crystallizing solution, presence and type of reagent in the crystallizing solution, amount of the crystallizing solution per pattern, type of diagnosed disorder, and sensitivity and specificity of the method.
 
 Results: The different diagnostic methodologies concerned mainly the crystallization of blood, plasma, serum and saliva, however also tears, urine, cerebrospinal fluid, vaginal mucosa, and sweat were used. The concentration of the sample in the crystallizing solution ranged from 100% to trace amounts. In case of diluted samples additions of salts, amino acids, neurotransmitters were used. The volume of the crystallization solution per pattern ranged from 3 μl to 6ml. The evaporation took place on a glass surface in forms of droplets, smears, or on round dishes (10cm diameter). The methodologies were applied for the diagnoses of cancer (different types and stages, including pre-symptomatic diagnosis), other diseases (e.g. diabetes, hepatitis B&C, multiple sclerosis, tuberculosis, cystic fibrosis, Sjogren’s syndrome, gastro-intestinal disorders, colon polyps, senile dementia), and physiological stages (fertility days and pregnancy in women, differences before and after physical activity). Finally, the mean sensitivity of the methods amounted to 82.1% (from 40.6% to 100%) and the mean specificity to 84.9% (from 62.3% to 96.7%). 
 In overall the experimental methodologies can be divided into following groups:
 - Evaporation of droplets of an undiluted biological fluid, 
 - Evaporation of droplets of a diluted biological fluid with addition of salts, 
 - Evaporation of droplets of a diluted biological fluid with addition of salts and amino acids, 
 - Evaporation of droplets containing salts, amino acids and neurotransmitters,
 - Evaporation of droplets of a watery solution of ashes of a biological fluid (spagyric crystallization),
 - Evaporation of films/smears of an undiluted biological fluid (ferning tests),
 - Evaporation of larger amounts of crystallizing solution of a strongly diluted biological fluid with addition of copper chloride placed on dishes (Pfeiffer’s crystallization),
 Within the analyzed literature there were 10 works on crystallization applied for homeopathy. They concerned three different crystallization approaches, all characterized by a low concentration of the analyzed sample in the crystallization solution (from 1% to trace amounts), or even its absence. These methodologies, besides blood, concerned also plant models and crystallization of the homeopathic preparations by themselves (without a biological sample). In these approaches the crystallization took place with or without the addition of a reagent (salt).
 
 Summary & Conclusions: Our preliminary results indicate that crystallization based methods might constitute in future valid, non-invasive, and cost-saving tools enabling, inter alia, pre-symptomatic cancer diagnosis. The studies on crystallization based methods applied to homeopathic research point at a great potential of these methodologies for both basic research and possibly also clinical applications and screening tests.
 
 Disclosure Information: The Authors declare that there is no conflict of interest.

The impact of the CervicalCheck controversy on provision of colposcopy services in Ireland: A cohort study

ObjectivesIn 2018, an inquiry into the Irish Cervical Cancer screening programme (CervicalCheck) was initiated, following publicised cases of non-disclosure regarding internal audit results of cytology screening in women diagnosed with cervical cancer. The inquiry attracted widespread media coverage and the government offered women free, out of programme screening. We investigated whether the controversy led to an increase in referrals based on clinical suspicion and the impact on waiting times for abnormal cytology. Study designA retrospective cross-sectional analysis was performed, including all colposcopy referrals to The National Maternity Hospital, Dublin, before (March 2016–2018) and after (March 2018–2020) the media coverage. Chi-squared (χ2) and independent one-tailed t-tests were used to perform between-group analyses. ResultsPost-controversy, suspicious cervix referrals increased (10.1 %–14.2 %; p = 0.037 × 10−27), as did colposcopic impression of CIN (p = 0.000000016). While an increase in CIN1 histology (18.5 %–30.3 %) was diagnosed, a decrease in high-risk CIN2 (10 % to 8.6 %), CIN3 (6.2 % to 2.9 %), AIS (1.2 % to 0.3 %) and invasive cancer (2.8 % to 1.2 %; p = 0.0058 × 10−9) were diagnosed. Across all grades of cytological abnormality, significantly fewer patients were reviewed in the recommended waiting time post-controversy. Half of delayed abnormal cytology referrals had high-grade changes. ConclusionsThis study highlights the profound impact that the CervicalCheck Controversy had on the women attending colposcopy and clinicians performing the screening tests, and the direct impact on women with confirmed cytological abnormalities. The increase in suspicious cervix referrals reflects a lack of confidence in both clinical practice and screening test results. The importance of public trust in the effective delivery of screening services cannot be ignored. Increased resources are required to ensure all women are seen within recommended time frames. Heightened anxiety and increased surveillance does not necessarily lead to better clinical outcomes for patients but can result in unnecessary distress for low-risk patients and delays to diagnosis for high-risk patients with concerning abnormalities.

DYSPHAGIA IN FIBROMYALGIA SYNDROME IN WOMEN: TRUTH OR MYTH? A CASE CONTROL STUDY

Purpose: This study was aimed to investigate the presence of dysphagia with multidimensional objective tests in FM female patients with and without dysphagia symptom compared to healthy female subjects. Methods: A case control study was conducted on 165 subjects (21 FM patients with dysphagia symptom, 62 FM patients without dysphagia symptom and 82 healthy subjects). All subjects were evaluated with a clinical screening test, endoscopy, electrophysiology of swallowing (dysphagia limit and swallowing intervals) and musculoskeletal ultrasound (cross-sectional thickness and area of swallowing muscles). Patients (with and without dysphagia symptom) and healthy subjects were compared in terms of all evaluation parameters. Results: The mean age of 165 subjects was [Formula: see text] years and all subjects ([Formula: see text], 100%) were female. Endoscopic evaluation results were similar among three groups ([Formula: see text]). Both the functional evaluation of swallowing measured by swallowing intervals ([Formula: see text]-value between 0.001 and 0.004) and the structural features assessed by the ultrasound ([Formula: see text]-value between 0.001 and 0.007) were significantly impaired in patient groups compared to healthy subjects. FM patients without dysphagia symptom also had significant impairments in function ([Formula: see text]-value between 0.001 and 0.004 for swallowing intervals) and structural features ([Formula: see text]-value between 0.001 and 0.007 for cross-sectional thickness and area of swallowing muscles) compared to healthy subjects. Conclusion: The structure and function of swallowing may be affected in patients with FM, even without dysphagia symptoms.

Neurodegenerative dementias: screening for major threats to healthy longevity with blood biomarkers

Clinical screening tests are readily available for most major age-associated diseases, including cardiovascular disease, type 2 diabetes, and common cancers. However, one of the most common causes of death in older adults—dementia—lacks a readily available early screening test that can be used in primary care. According to WHO, approximately 50 million people currently have dementia, and it is a leading cause of disability, dependency, and death among older people worldwide, making it a major threat to healthy human longevity.

Lysosomal Storage Disorders: Clinical, Biochemical and molecular profile from Rare disease centre, India.

Introduction:Lysosomal storage disorders (LSDs) are a heterogeneous group of large molecule inborn errors of metabolism, rather commonly seen by clinician.Objectives:This study aims to highlight the more common type of LSDs, their frequency, clinical spectrum and outcome from Rare disease centre in Rajasthan.Methods:The retrospective data were collected including clinical profile, investigations, screening test and enzyme analysis results. All outcomes were recorded from follow-up clinic.Results:This cohort comprised 65 children with different type of LSDs including 54 males and 11 females. The average age of presentation of the LSD patients was 3.5 years (range 6 months to 13 years). Gaucher disease was the most commonly found LSD (46.1%) followed by mucopolysaccharidosis (35.3%). Common presentations among GD patients were anemia, thrombocytopenia, and abdominal distension due to splenohepatomegaly/hepatomegaly. Among MPS Disorder, MPS type 2 (Hunter syndrome) was the most common (39.1%), followed by MPS type 1(Hurler syndrome) (30%) and MPS type IVA (Morquio syndrome) (17.3%). Non GD non MPS group comprised most commonly of GM1 gangliosidosis followed by pompe disease, Metachromatic Leucodystrophy, Mucolipidosis type II (I cell disease), and Sandhoff disease.Conclusions:LSDs comprises an important group of genetic metabolic disorders. Among these GD are the most common, followed by MPS.

Development of a Clinical MALDI-ToF Mass Spectrometry Assay for SARS-CoV-2: Rational Design and Multi-Disciplinary Team Work.

The COVID-19 pandemic caused by the SARS-CoV-2 coronavirus has stretched national testing capacities to breaking points in almost all countries of the world. The need to rapidly screen vast numbers of a country’s population in order to control the spread of the infection is paramount. However, the logistical requirement for reagent supply (and associated cost) of RT-PCR based testing (the current front-line test) have been hugely problematic. Mass spectrometry-based methods using swab and gargle samples have been reported with promise, but have not approached the task from a systematic analysis of the entire diagnostic process. Here, the pipeline from sample processing, the biological characteristics of the pathogen in human biofluid, the downstream bio- and physical-chemistry and the all-important data processing with clinical interpretation and reporting, are carefully compiled into a single high-throughput and reproducible rapid process. Utilizing MALDI-ToF mass spectrometric detection to viral envelope glycoproteins in a systems biology-multidisciplinary team approach, we have achieved a multifaceted clinical MALDI ToF MS screening test, primarily (but not limited to) SARS-CoV-2, with direct application to other future epidemics/pandemics that may arise. The clinical information generated not only includes SARS-CoV-2 coronavirus detection–(Spike protein fragments S1, S2b, S2a peaks), but other respiratory viral infections detected as well as an assessment of generalised oral upper respiratory immune response (elevated total Ig light chain peak) and a measure of the viral immune response (elevated intensity of IgA heavy chain peak). The advantages of the method include; (1) ease of sampling, (2) speed of analysis, and much reduced cost of testing. These features reveal the diagnostic utility of MALDI-ToF mass spectrometry as a powerful and economically attractive global solution

Cough reflex testing in acute stroke: A survey of current UK service provision and speech and language therapist perceptions.

Silent aspiration (SA)-airway entry of food, drink or other material without a cough response-is common post-stroke. Clinical swallowing examination misses up to 40% of dysphagic patients with SA. This may put these patients at risk of aspiration pneumonia, prolonged length of hospital stay and increased healthcare costs. After stroke, the laryngeal cough reflex is frequently impaired with significant relationships between pneumonia rates and reduced cough strength and sensitivity. There has been a significant amount of recent interest in cough reflex testing (CRT) as a potential means to improve clinical identification of patients at risk of SA. However, there is a lack of consensus regarding the methodology and protocols for use of CRT with widely varying outcomes reported in the literature. To provide an overview of current practice in the UK with regards to clinical use of CRT by speech and language therapists (SLTs) in acute stroke settings and to explore the perceptions regarding its potential application in clinical dysphagia management and the barriers and facilitators associated with adopting CRT in clinical practice. A cross-sectional web-based survey was developed, piloted and delivered. The survey targeted all UK-based SLTs working in acute stroke settings. A total of 129 SLTs with varying levels of experience of CRT from all regions of the UK responded. Only four SLT services in the UK were reported to be currently using CRT clinically with acute stroke patients. A total of 29% of respondents who were not using CRT were considering introducing CRT into their service's dysphagia protocol. Variation was reported in the procedures and protocols. Overall, users reported improved confidence in the clinical detection of SA and felt that the introduction of CRT had improved their patient-related outcomes. Issues included difficulties procuring citric acid, implications for SLT time (including service set-up and delivery of CRT) and restricted access to instrumental assessments. This survey gives valuable insight into the current practice and perceptions of SLTs in the UK working in acute stroke settings in relation to CRT. It highlights discrepancies between reported approaches and recommendations from existing guidelines and validation studies. The variation in responses indicates a need to develop a consensus statement and further research to guide practice. What this study adds What is already known on the subject CRT is gaining popularity as a screening tool for the clinical identification of SA with acute stroke patients. However, there is a lack of consensus in the literature regarding the methodology and protocols with widely varying outcomes. Further work needs to be done to standardize its use, especially if it is to be incorporated into dysphagia protocols for use in the acute stroke setting. What this paper adds to existing knowledge This survey of SLTs working in acute stroke settings highlights variability in practice in CRT service delivery in the UK, reflecting findings from the existing CRT literature. What are the potential or actual clinical implications of this work? The findings of this study support the need for further research relating to clinical screening tests for SA and standardization of methodology and protocols for CRT use if its use is to be continued clinically.