Diagnostic Accuracy of Monofilament Tests for Detecting Diabetic Peripheral Neuropathy: A Systematic Review and Meta-Analysis.
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ABSTRACT:
SUBMITTER: Wang F
PROVIDER: S-EPMC5651135 | biostudies-literature | 2017
REPOSITORIES: biostudies-literature
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Diagnostic Accuracy of Monofilament Tests for Detecting Diabetic Peripheral Neuropathy: A Systematic Review and Meta-Analysis.
Wang Fengyi F Zhang Jiaqi J Yu Jiadan J Liu Shaxin S Zhang Rengang R Ma Xichao X Yang Yonghong Y Wang Pu P
Journal of diabetes research 20171008
<h4>Objective</h4>To systematically evaluate the diagnostic accuracy of monofilament tests for detecting diabetic peripheral neuropathy.<h4>Methods</h4>We searched EMBASE (OvidSP), MEDLINE (OvidSP), the Cochrane Library, and Web of Science to identify diagnostic accuracy trials of monofilament tests for detecting diabetic peripheral neuropathy. We used a hierarchical summary receiver operating characteristics (HSROC) model to conduct the meta-analysis of diagnostic accuracy of monofilament tests ...[more]
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Project description:BACKGROUND:Various tests are used to detect diabetic peripheral neuropathy by assessing sense perception in the feet. Tests vary in terms of time and resources required. Simple tests are those that can be conducted quickly and easily in primary care without laboratory equipment. There are some limitations to these simple tests, an example being the variable amplitude of the 128 Hz tuning fork. A new test, VibraTip (McCallan Medical, UK), might be a valuable alternative as it emits a consistent amplitude and may offer improved diagnostic accuracy. OBJECTIVE:The aims of this study are to estimate the diagnostic accuracy of the VibraTip device for diabetic peripheral neuropathy against the reference standard of sural nerve conduction velocity measurement, and to assess whether the VibraTip offers superior diagnostic accuracy to other routine tests based on vibration or touch. METHODS:The study will prospectively recruit adults with type 2 diabetes who are due to attend a routine follow-up clinic. A cross-sectional study design will be employed to assess the diagnostic accuracy of 5 standard index tests for peripheral neuropathy, including VibraTip. The reference test will be sural nerve conduction velocity measurement. RESULTS:Funding is being sought to conduct this research. The outcomes assessed will be the diagnostic accuracy of the 5 index tests against sural nerve conduction velocity measurement, including sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio. Receiver operating characteristic curves will be constructed and compared for each test. CONCLUSIONS:This study will be the first within-study comparison of 5 simple tests for screening diabetic peripheral neuropathy and will address uncertainties in the potential benefits of using VibraTip in comparison with the other tests.
| S-EPMC5910530 | biostudies-literature
Project description:ObjectivesTo determine the diagnostic accuracy of different endometrial sampling tests for detecting endometrial carcinoma.DesignSystematic review and meta-analysis of studies of diagnostic accuracy.Data sourcesCochrane Library, MEDLINE/PubMed, CINAHL, Web of Science and Scopus, from the date of inception of the databases to 18 January 2023. Additionally, the reference lists of included studies and other systematic reviews were thoroughly searched.Eligibility criteriaWe included published cross-sectional studies that evaluated any endometrial sampling test (index tests) in women (participants) with clinical suspicion of endometrial carcinoma (target condition) in comparison with histopathology of hysterectomy specimens (reference standard). We excluded case-control and case series studies. No restrictions on language or date of publication were applied.Data extraction and synthesisTwo independent reviewers extracted study data and assessed study quality using the revised quality assessment tool for diagnostic accuracy studies (QUADAS-2). We used bivariate diagnostic random-effects meta-analysis and presented the results in a summary receiver operating characteristic curve. We assessed the certainty of evidence as recommended by the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) approach.ResultsTwelve studies (1607 participants), published between 1986 and 2022, contributed data to the meta-analysis results. Seven studies were judged to be at a low risk of bias in all domains and all studies had low applicability concerns. The most studied index tests were Pipelle and conventional dilation and curettage (D&C). The sensitivity, specificity, positive likelihood ratio and negative likelihood ratio (95% CIs) for Pipelle were 0.774 (0.565 to 0.900), 0.985 (0.927 to 0.997), 97.000 (14.000 to 349.000) and 0.241 (0.101 to 0.442) and for conventional D&C were 0.880 (0.281 to 0.993), 0.984 (0.956 to 0.995), 59.300 (14.200 to 153.000) and 0.194 (0.007 to 0.732), respectively.ConclusionHigh certainty evidence indicates that endometrial sampling using Pipelle or conventional D&C is accurate in diagnosing endometrial cancer. Studies assessing other endometrial sampling tests were sparse.Trial registration numberhttps://osf.io/h8e9z.
| S-EPMC10314649 | biostudies-literature
Project description:BackgroundCurrently, diabetic peripheral neuropathy (DPN) is one of the most severe complications of diabetes mellitus (DM). Despite the seriousness of this problem, limited evidence is available on the prevalence of diabetic peripheral neuropathy among patients with diabetes mellitus in Ethiopia. In Ethiopia, there were no updated studies that estimate the national prevalence of DPN. Hence, this systematic review and meta-analysis provided a national prevalence of diabetic peripheral neuropathy among patients with diabetes mellitus in Ethiopia.MethodsThis study was submitted for registration with the International Prospective Register of Systematic Reviews (PROSPERO) in March 2020 and accepted with the registration number CRD42020173831. Different database searching engines were searched online to retrieve related articles, including PubMed, Scopus, Google Scholar, African Journals Online, World Health Organization (WHO) Afro Library, and Cochrane Review. The reviewers used the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guideline in the reviewing process. In this systematic review and meta-analysis, all published and unpublished articles were analyzed. The reviewers used the random effects model to estimate the pooled prevalence of diabetic peripheral neuropathy among diabetes mellitus patients. The reviewers conducted the statistical analysis using the R version 3.5.3 and RStudio version 1.2.5033 software for Windows. The reviewers evaluated the heterogeneity across the included studies by the inconsistency index (I 2). The reviewers examined the publication bias by the funnel plot.ResultsThe search of the databases produced 245 papers. After checking the inclusion and exclusion criteria, 38 articles with 14029 total patients with diabetes mellitus were found suitable for the review. Except for three (retrospective cohort study), all studies were cross-sectional. The overall pooled prevalence of diabetic peripheral neuropathy was 22% (95% CI 18% to 26%). The subgroup analysis of diabetic peripheral neuropathy among patients with diabetes in the different regions was 23% (95% CI 17% to 29%) in Addis Ababa, 27% (95% CI 16% to 38%) in Oromia, 16% (95% CI 14% to 18%) in South nation and nationalities, and 15% (95% CI 6% to 24%) in Amhara.ConclusionsMore than one-fifth of patients with diabetes have diabetic peripheral neuropathy. According to this study, the prevalence of diabetic peripheral neuropathy in Ethiopia is considerably high. This evidence suggests that attention should be given to patients with diabetes in monitoring patients' blood glucose.
| S-EPMC7880716 | biostudies-literature
Project description:BackgroundHaving a penicillin allergy label associates with a higher risk for antibiotic resistance and increased health care use.ObjectiveWe sought to assess the accuracy of skin tests and specific IgE quantification in the diagnostic evaluation of patients reporting a penicillin/β-lactam allergy.MethodsWe performed a systematic review and diagnostic accuracy meta-analysis, searching on MEDLINE, Scopus, and Web of Science. We included studies conducted in patients reporting a penicillin allergy and in whom skin tests and/or specific IgE quantification were performed and compared with drug challenge results. We quantitatively assessed the accuracy of diagnostic tests with bivariate random-effects meta-analyses. Meta-regression and subgroup analyses were performed to explore causes of heterogeneity. Studies' quality was evaluated using QUADAS-2 criteria.ResultsWe included 105 primary studies, assessing 31,761 participants. Twenty-seven studies were assessed by bivariate meta-analysis. Skin tests had a summary sensitivity of 30.7% (95% CI, 18.9%-45.9%) and a specificity of 96.8% (95% CI, 94.2%-98.3%), with a partial area under the summary receiver-operating characteristic curve of 0.686 (I2 = 38.2%). Similar results were observed for subanalyses restricted to patients reporting nonimmediate maculopapular exanthema or urticaria/angioedema. Specific IgE had a summary sensitivity of 19.3% (95% CI, 12.0%-29.4%) and a specificity of 97.4% (95% CI, 95.2%-98.6%), with a partial area under the summary receiver-operating characteristic curve of 0.420 (I2 = 8.5%). Projected predictive values mainly reflect the low frequency of true penicillin allergy.ConclusionsSkin tests and specific IgE quantification appear to have low sensitivity and high specificity. Because current evidence is insufficient for assessing the role of these tests in stratifying patients for delabeling, we identified key requirements needed for future studies.
| S-EPMC8019189 | biostudies-literature
Project description:BACKGROUND:Diabetes mellitus (DM) is a global health care problem that can impose a substantial economic burden. Diabetic peripheral neuropathy (DPN) is a common microvascular complication of DM that increases the potential for morbidity and disability due to ulceration and amputation. Though there is a significant amount of variation in the primary studies on DM regarding the prevalence of DPN in Africa. Hence, this study was aimed to estimate the overall prevalence of DPN in DM patients in Africa. METHODS:PubMed, Scopus, Google Scholar, African Journals OnLine, WHO African Library, and the Cochrane Review were systematically searched online to retrieve related articles. The Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines was followed. Heterogeneity across the included studies was evaluated by the inconsistency index (I2). Publication bias was examined by funnel plot and Egger's regression test. The random-effect model was fitted to estimate the pooled prevalence of diabetic peripheral neuropathy among patients in Africa. The meta-analysis was performed using the STATA™ Version 14 software. RESULTS:Twenty-three studies which includes 269,691 participants were included in the meta-analysis. The overall pooled prevalence of diabetic peripheral neuropathy was 46% (95% CI:36.21-55.78%). Based on the subgroup analysis, the highest prevalence of diabetic peripheral neuropathy in DM patients was reported in West Africa at 49.4% (95% CI: 32.74, 66.06). CONCLUSION:This study revealed that the overall prevalence of diabetic peripheral neuropathy is relatively high in Africa. Hence, DPN needs situation-based interventions and preventive strategies, which are specific to the country. Further meta-analysis is needed to identify associated factors for the occurrence of diabetic peripheral neuropathy.
| S-EPMC7158034 | biostudies-literature
Project description:ObjectiveTo determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19).DesignSystematic review and meta-analysis.Data sourcesMedline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19.Eligibility criteria and data analysisEligible studies measured sensitivity or specificity, or both of a covid-19 serological test compared with a reference standard of viral culture or reverse transcriptase polymerase chain reaction. Studies were excluded with fewer than five participants or samples. Risk of bias was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using random effects bivariate meta-analyses.Main outcome measuresThe primary outcome was overall sensitivity and specificity, stratified by method of serological testing (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), or chemiluminescent immunoassays (CLIAs)) and immunoglobulin class (IgG, IgM, or both). Secondary outcomes were stratum specific sensitivity and specificity within subgroups defined by study or participant characteristics, including time since symptom onset.Results5016 references were identified and 40 studies included. 49 risk of bias assessments were carried out (one for each population and method evaluated). High risk of patient selection bias was found in 98% (48/49) of assessments and high or unclear risk of bias from performance or interpretation of the serological test in 73% (36/49). Only 10% (4/40) of studies included outpatients. Only two studies evaluated tests at the point of care. For each method of testing, pooled sensitivity and specificity were not associated with the immunoglobulin class measured. The pooled sensitivity of ELISAs measuring IgG or IgM was 84.3% (95% confidence interval 75.6% to 90.9%), of LFIAs was 66.0% (49.3% to 79.3%), and of CLIAs was 97.8% (46.2% to 100%). In all analyses, pooled sensitivity was lower for LFIAs, the potential point-of-care method. Pooled specificities ranged from 96.6% to 99.7%. Of the samples used for estimating specificity, 83% (10 465/12 547) were from populations tested before the epidemic or not suspected of having covid-19. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).ConclusionHigher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed. Currently, available evidence does not support the continued use of existing point-of-care serological tests.Study registrationPROSPERO CRD42020179452.
| S-EPMC7327913 | biostudies-literature
Project description:Aim:To assess the diagnostic performance of lateral radiograph of the neck for supraglottitis in adults and children. Methods:Electronic database searches (including PubMed, EMBASE, CINAHL, Web of Science, and WHO International Clinical Trials Registry Platform) were carried out through July 2014. Citations of included studies and recent narrative reviews were searched. Studies that compared lateral radiograph of the neck with a reference standard of direct/indirect laryngoscopy were included. Two reviewers independently assessed the methodological quality of included studies by Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Results:Of 2,088 potentially relevant citations, two single-gate (cohort) studies and six two-gate (case-control) studies were identified. These included studies of design are at the moderate or high risk of bias in QUADAS-2. The pooled sensitivity from bivariate random-effects regression was 92.9% (95% confidence interval [CI], 88.5-95.9%) and the pooled specificity was 89.2% (95% CI, 85.9-91.9%), but the diagnostic value would be overestimated because of selection bias in the six two-gate studies. The sensitivity and specificity of the single-gate studies were 100.0% (95% CI, 92.2-100.0%) and 30.6% (95% CI, 15.5-35.6%) in children and 81.0% (95% CI, 78.2-93.2%) and 85.7% specificity (95% CI, 78.2-93.2%) in adults. Conclusion:This study determines that there are insufficient studies of lateral neck radiograph for detecting supraglottitis. Lateral radiograph of the neck seems to have moderate accuracy for detecting supraglottitis. Further approximately unbiased studies are needed to obtain more valid and reliable estimates of test accuracy.
| S-EPMC5667265 | biostudies-literature
Project description:The skin's rewarming rate of diabetic patients is used as a diagnostic tool for early diagnosis of diabetic neuropathy. At present, the relationship between microvascular changes in the skin and diabetic neuropathy is unclear in streptozotocin (STZ) diabetic rats. The aim of this study was to investigate whether the skin rewarming rate in diabetic rats is related to microvascular changes and whether this is accompanied by changes observed in classical diagnostic methods for diabetic peripheral neuropathy. Computer-assisted infrared thermography was used to assess the rewarming rate after cold exposure on the plantar skin of STZ diabetic rats' hind paws. Peripheral neuropathy was determined by the density of intra-epidermal nerve fibers (IENFs), mechanical sensitivity, and electrophysiological recordings. Data were obtained in diabetic rats at four, six, and eight weeks after the induction of diabetes and in controls. Four weeks after the induction of diabetes, a delayed rewarming rate, decreased skin blood flow and decreased density of IENFs were observed. However, the mechanical hyposensitivity and decreased motor nerve conduction velocity (MNCV) developed 6 and 8 weeks after the induction of diabetes. Our study shows that the skin rewarming rate is related to microvascular changes in diabetic rats. Moreover, the skin rewarming rate is a non-invasive method that provides more information for an earlier diagnosis of peripheral neuropathy than the classical monofilament test and MNCV in STZ induced diabetic rats.
| S-EPMC4436028 | biostudies-literature
Project description:Background:This study aimed to assess the agreement and efficacy of the Ipswich Touch Test compared to the monofilament test in individuals with type 2 diabetes. Materials and methods:A cross-sectional and analytical study was conducted. The inclusion criteria were patients with type II diabetes (n?=?250) who did not present ulcers or amputation in either foot. The exclusion criteria were as follows: patients who presented sequelae of cerebrovascular disease or other neurological pathologies, as well as diagnoses of malignancy, alcohol abuse, liver cirrhosis, hepatitis B, AIDS, hypothyroidism, chronic kidney disease or lupus erythaematosus, as these clinical conditions could influence or bias the results (Won and Park in Endocrinol Metab 31:230-238, 2016). Sensitivity, specificity, predictive values, likelihood ratios, and Kappa index were calculated. Other factors assessed were glycated haemoglobin and body mass index. Results:Most of the participants were female (71.2%), and glycated haemoglobin (HbA1c) was greater than 7% in 54.4% of the patients. The mean age was 59.43 years, and the mean time since diagnosis was 12.38 years. The Kappa index was 0.819 (p?<?0.001), and the Ipswich Touch Test had a sensitivity of 83.33%, a specificity of 97.66%, a positive predictive value of 85.71%, a negative predictive value of 97.21%, a positive likelihood ratio of 30.19%, and a negative likelihood ratio of 0.17%. The level of significance was 5% in this study. Conclusion:The Ipswich Touch Test resented good agreement and efficacy compared to the gold standard-the 10 g monofilament test.
| S-EPMC7110690 | biostudies-literature
Project description:ObjectiveTo collate the evidence on the accuracy parameters of all available diagnostic methods for detecting SARS-CoV-2.MethodsA systematic review with meta-analysis was performed. Searches were conducted in Pubmed and Scopus (April 2020). Studies reporting data on sensitivity or specificity of diagnostic tests for COVID-19 using any human biological sample were included.ResultsSixteen studies were evaluated. Meta-analysis showed that computed tomography has high sensitivity (91.9% [89.8%-93.7%]), but low specificity (25.1% [21.0%-29.5%]). The combination of IgM and IgG antibodies demonstrated promising results for both parameters (84.5% [82.2%-86.6%]; 91.6% [86.0%-95.4%], respectively). For RT-PCR tests, rectal stools/swab, urine, and plasma were less sensitive while sputum (97.2% [90.3%-99.7%]) presented higher sensitivity for detecting the virus.ConclusionsRT-PCR remains the gold standard for the diagnosis of COVID-19 in sputum samples. However, the combination of different diagnostic tests is highly recommended to achieve adequate sensitivity and specificity.
| S-EPMC7350782 | biostudies-literature