The Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) has been widely accepted in the assessment of diagnostic accuracy and quality. However, it is not suitable for assessing risk of bias in studies comparing diagnostic accuracy. The current common practice in systematic reviews is to derive comparative accuracy from non-comparative diagnostic accuracy studies, which is inherently biased. The QUADAS group developed the QUADAS-Compare (QUADAS-C) tool for assessing the risk of bias in comparative diagnostic accuracy studies. It was officially launched in October 2021. QUADAS-C retains the same 4-domain structure as QUADAS-2: patient selection, index test, reference standard, and flow and timing. It also includes an additional 14 signaling questions and 4 risk of bias questions. This allows researchers to identify high-quality research evidence and avoid bias in research design and conduct. This article interpreted the basic situation, evaluation items, evaluation standards, and usage methods and procedures associated with QUADAS-C to provide references for domestic users.
With the development of artificial intelligence, machine learning has been widely used in diagnosis of diseases. It is crucial to conduct diagnostic test accuracy studies and evaluate the performance of models reasonably to improve the accuracy of diagnosis. For machine learning-based diagnostic test accuracy studies, this paper introduces the principles of study design in the aspects of target conditions, selection of participants, diagnostic tests, reference standards and ethics.
The comparative diagnostic test accuracy (CDTA) study is an important part of diagnostic test accuracy, which aims to compare the accuracy of two or more index tests in the same study. With the development of CDTA studies and the methodology of systematic reviews, the number of CDTA systematic reviews has grown year by year and has provided evidence to support clinical decision-making. Compared with systematic review of single diagnostic test accuracy, the CDTA systematic review has its own unique features, especially in data extraction, risk of bias, and statistical analysis. This paper introduced the steps and precautions for writing a CDTA systematic review to provide references for CDTA systematic reviewers.
ObjectiveTo systematically review the diagnostic value of T-SPOT.TB and QuantiFERON-TB (QFT-GIT/QFT-Plus) in active tuberculosis (ATB). MethodsThe PubMed, Web of Science, Cochrane Library, EMbase, CNKI, WanFang Data, and CBM databases were electronically searched to collect diagnostic accuracy studies comparing QFT-GIT/QFT-Plus and T-SPOT.TB for diagnosing ATB from inception to February 8, 2022. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies, then, meta-analysis was performed by using Stata 16.0 software. ResultsA total of 20 studies were included. The results of meta-analysis showed that the pooled sensitivity of T-SPOT.TB and QFT-GIT were 0.89 (95%CI 0.85 to 0.92) and 0.84 (95%CI 0.79 to 0.89), the pooled specificity were 0.85 (95%CI 0.68 to 0.93) and 0.86 (95%CI 0.72 to 0.94), the area under the curve (AUC) of summary receiver operating characteristic (SROC) were 0.93 (95%CI 0.84 to 0.97) and 0.90 (95%CI 0.56 to 0.99), respectively. The pooled sensitivity of T-SPOT.TB and QFT-Plus were 0.93 (95%CI 0.81 to 0.97) and 0.93 (95%CI 0.89 to 0.96), specificity were 0.99 (95%CI 0.39 to 1.00) and 0.94 (95%CI 0.67 to 0.99), the AUC of SROC were 0.99 (95%CI 0.67 to 1.00) and 0.98 (95%CI 0.65 to 1.00), respectively. ConclusionBoth T-SPOT.TB and QFT have high diagnostic accuracy for ATB, and the diagnostic sensitivity of T-SPOT.TB is better than QFT-GIT. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.
ObjectiveTo investigate the influence of the design and application of novel surgical template on the accuracy of reconstructed mandibula and implant position in occlusion-guided functional mandibular reconstruction, so as to provide guidance for clinical treatment.MethodsBetween January 2017 and May 2019, 11 patients with segmental mandible defects were treated, including 8 males and 3 females with an average age of 31.8 years (range, 19-45 years). There were 6 cases of ameloblastoma, 3 cases of keratocystic tumor, and 2 cases of ossifying fibroma. According to Urken classification of mandible defects, there were 1 case of CRB, 4 cases of RB, 2 cases of RBS, and 4 cases of SB. According to the occlusion relationship, a novel surgical template with the reconstruction titanium plate screws and implants drill-guided information was designed and manufactured. With the help of the novel surgical template, the “one and a half” fibula reconstruction mode was used for jaw functional reconstruction, and the implant supported denture was finally completed. The postoperative CT at 1 week were collected to analyze the morphology of the preoperative virtual design jaw and postoperative jaw. The coincidence of fibular reconstructed mandible (fibular upper barrel, fibular reconstructed ramus and condyle, and whole mandible) and implant in mandible were calculated. When the coincidence was less than 80%, it was considered that the deviation was obvious. Oral panoramic X-ray film and cone beam CT were examined at 6 months after operation to evaluate the osseointegration before implant repair.ResultsNone of the 11 flaps had postoperative vascular crisis. One flap occurred necrosis at 1 month after reconstruction combined with 3 implants failed, and had been removed at 6 months after reconstructed surgery; the others had no flap necrosis. One week postoperatively, the coincidence of the fibular upper barrel was 87.55%±3.08%, the whole mandible was 82.68%±5.94%, and the implant in mandible was 88.00%, with significant differences (t=8.131, P=0.000; t=2.118, P=0.046; Z=4.070, P=0.000) when compared to 80%, respectively. The fibular reconstructed ramus and condyle was 77.82%±3.54%, with no significant difference (t=−2.042, P=0.068) when compared to 80%. Six months postoperatively, oral panoramic X-ray film and cone beam CT showed that all 22 implants achieved osseointegration and the palatal mucosa transplantation was performed, then finally completed the denture rehabilitation at 6-9 months after operation. All patients were satisfied with their postoperative appearance.ConclusionThe novel surgical template can guarantee the accuracy of functional mandible reconstruction guided by occlusal guidance, and ultimately achieve the beautiful contour of jaw and occlusal function reconstruction, and improve the patient’s life quality.
Objective To investigate the accuracy of split three-dimensional (3D) printing patient-specific instrumentation (PSI) in medial open-wedge high tibial osteotomy (MOWHTO) and its effectiveness in treating medial knee osteoarthritis.MethodsClinical data of 14 patients with medial knee osteoarthritis and treated with split 3D printing PSI-assisted MOWHTO between August 2019 and August 2020 were retrospectively analyzed. There were 5 males and 9 females with an average age of 61 years (range, 43-68 years). The disease duration ranged from 1 to 16 years, with an average of 4.7 years. Preoperative Kellgren-Lawrence grading of knee osteoarthritis included grade Ⅰ in 2 cases, grade Ⅱ in 6 cases, and grade Ⅲ in 6 cases. The Hospital for Special Surgery (HSS) score was 59.1±4.9. The weight bearing line ratio (WBL), hip-knee-ankle angle (HKA), medial proximal tibial angle (MPTA), posterior tibial slope angle (PTSA), and actual correction angle of the lower limbs were measured on postoperative imaging data, and compared with the preoperative measurements and the designed target values to evaluate the accuracy of the PSI-assisted surgery. The patients’ knee function were evaluated with the HSS score at 3 and 6 months postoperatively, and at last follow-up.ResultsOne patient suffered from an incision exudation at 2 weeks postoperatively, and the incision healed after symptomatic treatment. The incisions of other patients healed by first intention. All patients were followed up 7-19 months (mean, 14.8 months). There was no neural injuries, hinge fracture, plate or screw fractures, loosening, or other complications. The WBL was maintained at the postoperative level according to the X-ray examination during the follow-up period. The WBL, HKA, MPTA, and PTSA were all within a satisfactory range after operation. The WBL, HKA, and MPTA were significantly improved when compared with the preoperative measurements (P<0.05). There was no significant difference between preoperative and postoperative PTSA (P>0.05). The differences in postoperative WBL, HKA, MPTA, and correction angle compared with the preoperative designed target values were not significant (P>0.05). The HSS scores were 69.2±4.7, 77.7±4.3, and 88.1±5.4 at 3 and 6 months postoperatively, and last follow-up, respectively. The differences between time points were significant (P<0.05).ConclusionFor patients with medial knee osteoarthritis, the split 3D printing PSI can assist the surgeon in MOWHTO with accurate osteotomy orthopedics and achieve favorable effectiveness.
ObjectiveTo explore the short-term effectiveness of Mako robot-assisted total hip arthroplasty (THA) via posterolateral approach.MethodsThe clinical data of 64 patients (74 hips) treated with Mako robot-assisted THA via posterolateral approach (robot group) between May 2020 and March 2021 were retrospectively analyzed and compared with the clinical data of 52 patients (55 hips) treated with traditional THA via posterolateral approach (control group) in the same period. There was no significant difference in general data such as gender, age, side, body mass index, disease type, and preoperative Harris score between the two groups (P>0.05). The operation time, intraoperative blood loss, and complications were recorded and compared between the two groups. Acetabular inclination angle, acetabular anteversion angle, and lower limbs discrepancy were measured after operation. At last follow-up, the improvement of hip pain and function was evaluated by visual analogue scale (VAS) score, Harris score, and forgetting joint score (FJS-12).ResultsIn the robot group, 3 patients (including 1 patient with acetabular fracture during operation) were converted to routine THA because the pelvic data array placed at the anterior superior iliac spine was loose, resulting in data error and unable to register the acetabulum; the other patients in the two groups completed the operation successfully. The operation time and intraoperative blood loss in the robot group were significantly higher than those in the control group (P<0.05). All patients were followed up 1-10 months, with an average of 4.6 months. In the robot group, 1 patient with ankylosing spondylitis had acetabular prosthesis loosening at 2 days after operation, underwent surgical revision, and 10 patients had lower limb intermuscular vein thrombosis; in the control group, 1 patient had left hip dislocation and 5 patients had lower extremity intermuscular vein thrombosis; there was no complication such as sciatic nerve injury, incision exudation, and periprosthetic infection in both groups. There was no significant difference in the incidence of complications between the robot group and the control group (17.2% vs.11.5%) (χ2=0.732, P=0.392). At last follow-up, the acetabular anteversion angle and FJS-12 score in the robot group were was significantly greater than those in the control group, and the lower limbs discrepancy was significantly less than that in the control group (P<0.05); there was no significant difference in acetabular inclination angle and VAS score between the two groups (P>0.05). The Harris scores of the two groups were significantly improved when compared with those before operation (P<0.05), but there was no significant difference in the difference of pre- and post-operative score between the two groups (t=1.632, P=0.119).ConclusionCompared with traditional surgery, Mako robot-assisted THA can optimize the accuracy and safety of acetabular cup implantation, reduce the length difference of the lower limbs, and has a certain learning curve. Its long-term effectiveness needs further research to confirm.
ObjectiveTo compare the investigation results of compliance and accuracy of hand hygiene in medical staff achieved by Hospital Infection Management Department and Department Infection Management Teams, and analyze the reasons for differences of the results and take measures to improve the investigation ability of hand hygiene in hospitals. MethodsWe statistically analyzed the results of compliance and accuracy of hand hygiene from January to December 2013 investigated by the infection management department and 25 infection management teams. Both the hospital and departments used "WHO Standard Observation Form". Single-blind method was used to observe the implementation of hand hygiene in medical staff. ResultsThe hospital infection management department investigation showed that hand hygiene compliance and accuracy were 64.97% and 87.78%, respectively, while the investigation by infection management teams showed that hand hygiene compliance and accuracy were 90.54% and 93.37%, respectively. The differences between the investigation results of two-level organizations were statistically significant (χ2=286.2, P<0.001; χ2=532.6, P<0.001). ConclusionWe should take measures to enforce the training of hand hygiene implementation and the observation method, and improve the guidance and assessment, promote investigators' working responsibility and observation ability, so that the survey data can accurately reflect the actual situation to urge medical staff to form good hand hygiene habits.
Objective To evaluate whether the paper titled “Application of tumor type M2 pyruvate kinase in the diagnosis of lung cancer” met the standards set in the STARD statement. Methods Based on each of the 25 items of STAndards for the Reporting of Diagnostic accuracy studies (STARD statement), the paper titled “Application of tumor type M2 pyruvate kinase in the diagnosis of lung cancer” was checked and evaluated. Results In the paper titled “Application of tumor type M2 pyruvate kinase in the diagnosis of lung cancer”, the reporting of 1 item of the STARD statement was adequately standardized, 7 items were relatively standardized, 5 items were inadequately standardized, 2 items were not standardized, and the other 10 were not reported. Conclusion Generally speaking, the reporting of diagnostic accuracy studies has not been standardized adequately in China. The methodological quality and applicability of diagnostic accuracy studies should be improved.
This paper introduced the preferred reporting items for journal and conference abstracts of systematic reviews and meta-analyses of diagnostic test accuracy studies (PRISMA-DTA for abstracts), which was published in BMJ in March 2021. This paper presented the 12 items of checklist, explanations, and examples of complete reporting, to help domestic researchers to report complete and informative abstracts of systematic reviews and meta-analyses of diagnostic test accuracy studies.