The interaction between medical instrument and target tissue during the surgery occurs in instrument-tissue interface. The reliability research on the interface is directly related to the safety and effectiveness of medical instrument in the clinical application. This paper illustrates the necessity of reliability research on instrument-tissue interface. Two main contents are synthetically reviewed the present paper: (1) reliability research on medical instruments; (2) biological tissue properties and its mechanical response.
Objective To examine the clinical utility of postoperation symptom inventory. Methods According to the current cancer symptom assessment tools, clinical guidelines and expert interviews, we preliminarily selected 10 common symptoms as an alternative item. Postoperative symptom assessment scale of lung cancer patients was formulated through expert evaluation. And 383 patients in eight hospitals were evaluated and validated using the scale to analyze the reliability and validity. Results Postoperation symptom inventory was easy to operate and evaluate for postoperative lung cancer patients in 8 symptoms (pain, shortness of breath, fatigue, cough, insomnia, throat pain, sweating and constipation). The scale was with high reliability. Cronbach' s α was 0.888. This scale was also with reliable validity. Content validity index was 0.900. There were two common factors with high cumulative proportion in variance(47.70% and 57.46%). And each question had high factor load and communality (>0.40) in the exploratory factor analysis. Conclusion The postoperation symptom inventory has excellent reliability and validity in patients with lung cancer surgery.
ObjectiveTo assess the reliability, effectiveness, and the safety of full endoscopic transforaminal decompression (FETD) under local anesthesia guided by the classification of lateral region of the lumbar spinal canal (CLLSC) in treating lumbar spinal stenosis (LSS) in geriatric patients.MethodsThe clinical data of 63 geriatric patients with LSS met the inclusion criteria underwent FETD surgery between June 2015 and July 2017 were retrospectively analyzed. There were 37 males and 26 females, with a median age of 76 years [interquartile range (IQR), 73-80 years], and a median symptomatic duration of 55 months (IQR, 16-120 months). There were 17 cases of grade B and 46 cases of grade C based on the Schizas morphological grading system. CLLSC was used for imaging evaluation for the stenotic condition, and intra-class correlation coefficients (ICC) were used to test intra-observer and inter-observer reliability of CLLSC. The stenotic condition of patients was re-evaluated by the surgeon after operation, and the results were compared with the findings of preoperative CLLSC. The visual analogue scale (VAS) score for low back pain and leg pain recorded before operation, and at 1 day, 3 months, and 6 months after operation, and last follow-up were used to assess the pain relieving; the functional improvement was evaluate by Oswestry disability index (ODI); the modified Macnab criteria were used to self-evaluate the surgical satisfaction.ResultsThe operation were successfully performed for all patients, with a median operation time of 75 minutes (IQR, 65-85 minutes), postoperative hospitalization stay of 48 hours (IQR, 48-72 hours), and the time to ambulation after operation of 24 hours (IQR, 24-24 hours). Sixty-three patients were followed-up and with a median follow-up time of 18 months (IQR, 13-20 months). Based on preoperative CLLSC classification, there were 72 stenotic zones, distributed 16 in zone 1, 6 in zone 2, 3 in zone 3, 2 in zone 4, 7 in zone 5, 34 in zones 1+2, 2 in zones 3+4, and 2 in zones 4+5. Perioperative complications occurred in 4 cases (6.3%), including 2 cases of intraoperative dural sac tear, 1 of preoperative numbness symptom aggravation, and 1 of postoperative urinary retention. VAS score of leg pain and ODI score at each time point after operation were significantly improved compared with those before operation (P<0.05). VAS scores of low back pain showed no significant difference between pre- and post-operation (P>0.05). At last follow-up, based on the modified Macnab criteria, 19 cases were excellent, 37 were good, 6 were fair, and 1 was poor, and the excellent and good rate was 88.9%. The reliability analysis showed that CLLSC had substantial intra-observer reliability in the geriatric population, with an average ICC of 0.78. There was also a substantial inter-observer reliability, with an average ICC of 0.73. While comparing the preoperative CLLSC results with the postoperative CLLSC results, 53 patients (73.6%) were in full agreement, 15 patients (20.8%) were in partial agreement, and 4 patients (5.6%) were not.ConclusionCLLSC has high reliability in the diagnosis of LSS in the geriatric patients. Combined FETD with CLLSC, accurate diagnosis, and minimal invasion can be performed to achieve safe and effective result.
ObjectiveBy establishing a set of evaluation system for thoracoscopic clinical function and applicability, to evaluate and compare the advantages and disadvantages of different brands of thoracoscopes, and to provide some suggestions for the innovation and upgrade of thoracoscopes, especially for the domestic thoracoscopes.MethodsThe project coordination team initially formulated the evaluation index system for the clinical function and applicability of thoracoscope by querying literature and brainstorming. The Delphi expert consultation method was used to distribute questionnaires to the selected experts. Experts provided scores which were based on the importance of each indicator, and clarified the basis of their judgment and the familiarity with the evaluation indicators. After two rounds of screening by Delphi method, a thoracoscopic clinical function and applicability satisfactory questionnaire was formed. The appropriate sample for pre-investigation was selected, and the reliability and validity were tested. The index composition was adjusted based on the results of the test to form a final evaluation scale.ResultsThe project coordination team initially formulated 24 thoracoscope-related evaluation indicators. After two rounds of experts consultation, the item "brightness adjustment" was deleted without any additional entries. The positive coefficients of the experts in the first round and the second round were 100.0% and 80.0%, respectively. The two rounds of authoritative coefficients were 0.86 and 0.90, and the coordination coefficients were 0.272 (P<0.001) and 0.523 (P<0.001), respectively. A total of 140 questionnaires were issued in this pre-investigation. The recovery rate was 100.0% and the effective rate was 90.0%. The Cronbach's α value of the scale was 0.936, and the Spearman-Brown split-half reliability coefficient was 0.972. The factor analysis finally extracted 3 common factors. The total variance of the cumulative interpretation was 70.9%. The three common factors were named "operation related", "image related" and "device related".ConclusionThe evaluation index system developed in this study has good reliability and validity, and can be used as a tool to evaluate the clinical function and applicability of thoracoscopes.
Objective To evaluate the reliability and validity of the Chinese version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS) in preoperative anxiety in patients with local anesthesia. Methods From May to December 2020, a convenient sampling method was used to conduct an APAIS questionnaire survey on patients undergoing percutaneous renal biopsy in the Department of Nephrology, West China Hospital, Sichuan University, and the reliability and validity of the scale were analyzed. ResultsA total of 460 questionnaires were distributed and 444 valid questionnaires were returned, with a valid response rate of 96.5%. The Cronbach α of APAIS was 0.896, the Guttman split-half reliability was 0.811, and the content validity index was 0.891. The model fit was 12.122 for the chi-square fit index/degree of freedom, 0.916 for the goodness-of-fit index, 0.902 for the value-added fit index, 0.079 for the root mean square error of approximation, and 0.946 for the comparative fit index. The APAIS anxiety subscale score was positively correlated with the 7-item Generalized Anxiety Disorder Scale score (r=0.518, P<0.001). Conclusion The APAIS has good reliability and validity for evaluating the level of preoperative anxiety in patients with local anesthesia, but the application of the scale in other conditions requires further testing.
Objective To evaluate the reliability and validity of the three-dimensional motion capture analysis system COFT-Motion® in evaluating the active range of motion of upper limbs in healthy subjects, and provide objective basis for its clinical application. Methods From January to March 2022, healthy subjects were publicly recruited for enrollment. The evaluator applied the three-dimensional motion capture analysis system COFT-Motion® and angle ruler to evaluate the active range of motion of the shoulder joint (flexion, extension, adduction, abduction) and elbow joint (flexion, extension) in healthy subjects. Pearson correlation analysis was used to evaluate validity, and intraclass correlation coefficient (ICC) was used to evaluate reliability. Results There was a positive correlation between the measurements of COFT-Motion® and the angle ruler of the active range of motion of upper limbs in healthy subjects. The Pearson correlation coefficients for active range of motion of the shoulder joint (flexion, extension, adduction, abduction) and elbow joint (flexion, extension) were 0.913, 0.964, 0.961, 0.941, 0.864, and 0.919, respectively (P<0.05). The results of using COFT-Motion® by different evaluators to evaluate the active range of motion of healthy subjects’ shoulder joints (flexion, extension, adduction, abduction) and elbow joints (flexion, extension) showed that the ICC values were 0.892, 0.942, 0.961, 0.988, 0.989, and 0.928, respectively (P<0.05). The results of repeated evaluations by the same evaluator showed that the ICC values were 0.795, 0.916, 0.900, 0.868, 0.918, and 0.911, respectively (P<0.05). Conclusion The application of the three-dimensional motion capture analysis system COFT-Motion® in healthy subjects has good validity and reliability. However, due to the limited sample size and subject of the study, further promotion and application of the system still need to be further explored.
Objective To verify the reliability and validity of a self-developed satisfaction evaluation questionnaire for outpatient department employees in public hospitals, and to provide suitable tools for conducting such surveys. Methods Two anonymous surveys were conducted on all employees of the Outpatient Department of West China Hospital of Sichuan University in July 2019 and November 2021, respectively. Questionnaire items were screened using methods such as item distribution, coefficient of variation, and decision value, and the reliability and validity of the questionnaire were evaluated using Spearman-Brown coefficient and Cronbach’s α coefficient, exploratory factor analysis, and confirmatory factor analysis. Results The final questionnaire retained 14 items, which could be divided into two dimensions: work conditions and interpersonal environment, and the overall fit index of structural equation model model were as follows: χ2/ν=6.957, standardized root mean square residual was 0.061, root mean square error of approximation was 0.147, goodness-of-fit index was 0.796, adjusted goodness-of-fit index was 0.719, normed fit index was 0.849, relative fit index as 0.819, incremental fit index was 0.868, Tucker-Lewis Index was 0.841, comparative fit index was 0.867. The combined reliability of the two factors in the questionnaire was 0.94 and 0.91, respectively. The average variance extraction was 0.67 and 0.76, respectively, and the square root of the average variance extraction was 0.82 and 0.87, both of which were greater than the correlation coefficient of 0.71 between the two factors. The Spearman-Brown coefficient of the final questionnaire was 0.913, and the Cronbach’s α coefficients for the overall and two dimensions were 0.953, 0.937, and 0.910, respectively. Conclusion The reliability and validity of the satisfaction evaluation questionnaire for outpatient department employees in public hospitals are good and can be applied to practical surveys.