The core idea of comparative effectiveness research (CER) refers to "study in the real-world" which can be considered as the extension of evidence-based medicine. So far CER has arouse wide concern. CER includes many intervention trials and observational studies, including systematic reviews/meta-analyses, effectiveness randomized controlled trials, and registry trials. Database is an important platform for CER. CER has better feasibility and can provide useful evidence for "real-world" decision-making. However, it also has limitations such as difficult control of confounding factors. It still needs to be further studied due to its immature methodological base. CER has been already applied in some neurological fields, with internationally-recommended research priorities for CER in neurology.
ObjectiveTo compare the results of internal limiting membrane (ILM) peeling with and without ILM transplantation to treat idiopathic macular hole (IMH) with hole form factor (HFF)<0.6. MethodsForty patients (40 eyes) of IMH with HFF<0.6 who underwent pars plana vitrectomy (PPV) were enrolled in this study. 20 eyes was performed PPV combined with ILM peeling (ILM peeling group), the other 20 eyes was performed PPV combined with ILM peeling and ILM transplant (ILM transplant group). The follow-up was ranged from 3 to 6 months with an average of 4 months. The changes of closing rate of hole, best corrected visual acuity (BCVA), photoreceptor inner segment/outer segment (IS/OS) junction defect diameter and amplitude of wave P1 of ring 1 and ring 2 by multifocal electroretinogram (mfERG) were comparatively analyzed for the two groups. ResultsIn 3 months after surgery, the IMH closing rate was 70% (14/20) in the ILM peeling group, and 100% (20/20) in the ILM transplant group, the difference between these two groups was significant (χ2=7.059, P<0.05). Postoperative BCVA was improved obviously in the two groups compared to preoperative BCVA, the difference was significant (t=4.017, 4.430; P<0.05). The rate of BCVA improvement in the ILM peeling group and ILM transplant group were 80% and 85%, the difference was not significant (χ2=0.173, P>0.05). The rate of significantly BCVA improvement in the ILM peeling group and ILM transplant group were 35% and 70%, the difference was significant (χ2=4.912, P<0.05). IS/OS junction defect (t=6.368, 6.635; P<0.05) and amplitude of wave P1 of ring 1 (t=2.833, 4.235) and ring 2 (t=2.459, 4.270) by mfERG in the two groups were improved after operation. The differences of postoperative IS/OS junction defect (t=2.261, P<0.05) and amplitude of wave P1 of ring 2 between the two groups were significant (t=2.282, P<0.05), but the differences of postoperative amplitude of wave P1 of ring 1 between two groups was not different (t=1.800, P>0.05). ConclusionPPV combined with ILM peeling and ILM transplantation can significantly improve the closure rate and vision of IMH with HFF<0.6.
Objective To investigate cost-effectiveness of no indwelling urinary catheter in pulmonary lobectomy patients and to confirm the advances of no indwelling urinary catheter. Methods We recruited 148 lung cancer patients who were scheduled for pulmonary lobectomy under general anesthesia in West China Hospital from July through December 2015. These patients were divided into two groups including an indwelling urinary catheter group (74 patients, 45 males and 29 females, at age of 52.55±19.87 years) and a no indwelling urinary catheter group (74 patients, 42 males and 32 females, at age of 54.03±16.66 years). Indexes of cost-effectiveness of the two groups were compared. Results There was no statistical difference between the two groups in duration of indwelling catheter (1.56±0.0.65 d versus 1.68±0.91 d, P=0.077). Material expense(4 811.48 yuan versus 296.74 yuan, P=0.045), cost of nursing care (7 413.32 yuan versus 457.32 yuan, P=0.013), and total expense (12 224.8 yuan versus 754.06 yuan, P=0.000) in the indwelling catheter group were higher than those in the no indwelling catheter group. Material expense per patient (65.02±5.62 yuan/patient-time versus 4.01±0.00 yuan/patient-time, P=0.000), cost of nursing care per patient (100.18±7.19 yuan/patient-time versus 6.18±1.22 yuan/patient-time, P=0.000), and total cost per patient (165.20±12.81 yuan/patienttime versus 10.19±1.22 yuan/patient-time, P=0.000) in the indwelling catheter group were higher than those in the no indwelling catheter group. Conclusion Both costs and labor of nurse can be cut down for appropriate lung cancer patients undergoing lobectomy without routine indwelling urinary catheter.
ObjectiveTo review research progress in the anterolateral ligament (ALL) of knee, and provide a clinical reference for diagnosis and treatment of ALL injury.MethodsThe literature on the diagnosis and treatment of ALL injury was widely reviewed. The incidence, anatomy, biomechanics, injury mechanism, and treatment status of ALL were summarized.ResultsThe ALL contributes to the effect of controlling the internal rotation and anterior translation of the tibia, which affects the axial migration of the knee. ALL injury can be diagnosed according to the signs and MRI examination. Currently, no consensus exists for the surgical indications of ALL injury, but most surgeons tend to perform ALL reconstruction in patients requiring anterior cruciate ligament (ACL) reconstruction or revision surgery with higher pivot-shift tests. At present, various techniques have been used for ALL reconstruction, and there is no optimal technique. In addition, the long-term effectiveness of ALL reconstruction is unclear due to the lack of high-quality studies and long-term postoperative follow-up.ConclusionThe ALL contributes to maintaining knee stability, and the ALL reconstruction technique and its effectiveness still need further research.
The application of economic tools to evaluate the cost and health benefits and screen out more cost-effective drugs and technologies is an important measure to improve efficiency of medical resource allocation in China. Given the inherent differences between strict clinical trials and clinical routine practice, using trial-based economic evaluations to guide relevant medical decisions may lead to a certain risk of value deviation. Recent development of real-world data provides opportunities to assess the cost-effectiveness of drugs under the practical utilization, and has gradually become a new research hotspot. However, the complexity of the actual clinical environment also puts higher demands on researchers and decision makers to construct, understand and apply real-world evidence. In order to further prompt the normalization of economic evaluation based on real-world data and promote the scientific application of real-world evidence in medical and health decision-making, this project aims at the crucial issues including scope, research design and quality evaluation, to clarify the key considerations on the using of real-world evidence in medical decision-making. Combined with the international guidelines, the latest advancement of relevant research areas and the advice and opinions from multidisciplinary experts, we aim to provide technical references and guidance for researchers and decision makers, and to strengthen the evidence base of management policies.
Objective To explore the short term and long term effectiveness of the problem-based learning (PBL) in clinical skill training. Methods A total of 162 clinical medicine undergraduates in Grade 2003 (7-years study) and 2004 (5-year study) who were supposed to intern in the internal medicine departments were randomly divided into the PBL group (n=75) and the control group with traditional training (n=87) for having their clinical skills training. Then t test was applied to compare the two groups about the scores of intern rotation examination and graduate OSCE as well. Results About the baseline: the students in the two groups got similar scores in their internal medicine exam before clinical intern rotation (84.04±7.40 vs. 82.63±8.77, P=0.287). About the short term effectiveness: compared to the control group, the students in the PBL group got higher subjective evaluation from their supervised clinicians (P=0.006). In writing examination, the students of those two group got similar scores in knowledge part (54.17±9.26 vs. 51.67±9.56, P=0.92), while the PBL group won in case reasoning question (20.39±5.27 vs. 16.51±4.90, Plt;0.001). About the long term effectiveness: in the graduate OSCE, the two groups got similar scores in skills operation such as punctures and lab results analyses (P=0.567 and P=0.741), while the students in the PBL group had better performance at the case reasoning and standard patients treating (75.59±9.85 vs. 71.11±12.01, P=0.027). Conclusion With the great short term and long term effectiveness, the PBL applied in the clinical skill training improves the students’ ability of both synthesized analyses and the integrated clinical skills such as clinical thinking and interpersonal communication, but doesn’t aim at the basic knowledge and operation skills.
Objective To investigate the long-term effectiveness of Ni-Ti memory alloy tripod fixator in the treatment of Kienb?ck disease. Methods The clinical data of 22 patients with Kienb?ck disease who were treated with Ni-Ti memory alloy tripod fixator between January 2011 and September 2013 and followed up more than 10 years was retrospectively analyzed. There were 14 males and 8 females with an average age of 45 years (range, 20-64 years). The Lichtman staging was stage Ⅲb. According to AO/Association for the Study of Internal Fixation (AO/ASIF) classification, there were 6 cases of type B1, 2 cases of type B2, 10 cases of type B3, and 4 cases of type C2. The disease duration ranged from 18 to 50 months, with an average of 30.7 months. The operation time, intraoperative blood loss, and complications were recorded. Wrist height ratio and scapholunate angle were measured by wrist anteroposterior and lateral X-ray films before and after operation. The grip strength of bilateral hands was measured by Jamar dynamometer. The wrist pain was evaluated by visual analogue scale (VAS) score, and the wrist function was evaluated by Mayo score, and the radial deviation, ulnar deviation, dorsiflexion, and palmar flexion range of motion of wrist were measured. Results The operation time was 45-60 minutes, with an average of 52.21 minutes; the intraoperative blood loss was 50-60 mL, with an average of 58.63 mL. No nerve or blood vessel injury occurred during operation. All patients were followed up 10-13 years (mean, 11.3 years). X-ray films at 3 months after operation showed that the density of lunate bone was lower than that before operation. Satisfactory fusion of the scapho-trapezio-trapezoeid joint was achieved at 3-6 months after operation (mean, 4.5 months), and the wrist height ratio and the scapholunate angle after fusion significantly improved when compared with those before operation (P<0.05). Wrist pain relieved, scaphoid rotation and dislocation improved, and no radiocarpal joint degeneration was found during follow-up, and no internal fixator loosening, breakage, or lunate bone necrosis occurred. At last follow-up, the wrist radial deviation, ulnar deviation, dorsiflexion, and palmar flexion range of motion, VAS score, and grip strength of the affected side significantly improved when compared with those before operation (P<0.05); the grip strength of the affected side recovered to 99.00%±1.25% of the healthy side. Mayo score ranged from 72 to 93, with an average of 85; 14 cases were rated as excellent, 5 good, and 3 satisfactory, the excellent and good rate was 86.4%. ConclusionIn the treatment of stage Ⅲb Kienb?ck’s disease, the scapho-trapezio-trapezoeid joint usion using Ni-Ti memory alloy tripod fixator can effectively reduce pain, improve hand function, and prevent further deterioration, and achieve good long-term effectiveness.
Methodological quality and transferability will be important issues for the credibility and usefulness of both published studies and administrative methods for evaluating the socio-economic value of marketed medicines in China. This paper critically examines factors commonly contributing to, or inhibiting, the quality and transferability of socio-economic evidence of the value of medicines, with specific reference to the Chinese community. It discusses appropriate approaches to design, performance, and reporting of published economic evaluation studies, as well as guides on assessment of quality of economic evaluations and recommends two internationally established methods that may be suitable for training in this setting.
Objective To describe a novel arthroscopic technique of modified tri-anchor double-pulley suture-bridge in repairing medium-sized supraspinatus tendon tears and evaluate the early effectiveness. Methods Between June 2021 and January 2024, 26 patients with medium-sized supraspinatus tendon tears who underwent arthroscopic modified tri-anchor double-pulley suture-bridge repair and met the selective criteria were included. There were 11 males and 15 females with an average age of 61.4 years (range, 43-74 years). Five patients had a significant history of trauma, while the remaining 21 patients had no apparent cause. The time from symptom onset to hospitalization was 3-25 months (mean, 7.9 months). The effectiveness was evaluated during follow-up, including the scores of University of California at Los Angeles (UCLA), American Shoulder and Elbow Surgeons (ASES), visual analogue scale (VAS), the range of forward flexion, abduction, external rotation, and internal rotation, and patient’s satisfaction. Either MRI or ultrasound examination were used to evaluate structural integrity of the tendon. Results The operation time was 65-110 minutes (mean, 81.8 minutes). All patients were followed up 12-43 months (mean, 23.0 months). At 3 and 12 months after operation, the shoulder range of flexion, abduction, external rotation, and internal rotation, and the scores of VAS, UCLA, and ASES significantly improved when compared with those before operation (P<0.05). The improvement was further observed at 12 months compared to 3 months (P<0.05). At last follow-up, 13 patients were very satisfied with the effectiveness, 11 patients were satisfied, 1 was relatively satisfied, and 1 was dissatisfied. During follow-up, 15 patients underwent imaging examination and imaging reexamination showed that the re-tear rate of tendon was 6.6%(1/15). The remaining 11 patients refused imaging examination. Complications included partial anchor withdrawal in 1 case, shoulder stiffness in 5 cases, and mild pain in shoulder joint in 2 cases in physical activity or heavy physical activity. Conclusion Arthroscopic modified tri-anchor double-pulley suture-bridge technique is a novel surgical technique that uses double-loaded suture anchors as medial- and lateral-row anchors. In repairing medium-sized supraspinatus tendon tears, 6 sets of double-pulley suture-bridges can be created from one medial-row anchor; knotless medial-row can reduce re-tear rate of the tendon; good early effectiveness is obtained.
Objective To compare the effectiveness of one-stage bilateral total hip arthroplasty by direct anterior approach (DAA) and by posterolateral approach, and to investigate the application value of DAA in one-stage bilateral total hip arthroplasty. Methods The clinical data of 65 patients who underwent one-stage bilateral total hip arthroplasty by DAA or posterolateral approach between June 2010 and November 2015 were analyzed retrospectively. DAA was used in 34 cases (group A) and posterolateral approach was used in 31 cases (group B). There was no significant difference in the gender, age, body mass index, preoperative hemoglobin level, etiology, disease duration, preoperative Harris score, and preoperative visual analogue scale (VAS) score between 2 groups (P>0.05) with comparability. The incision length, operation time, intraoperative blood loss, total blood transfusion volume, hospitalization time, early postoperative complications, Harris score, and VAS score were recorded and compared between 2 groups. The simple Likert scale method was applied to evaluate the patient satisfaction, and the imaging evaluation was used. Results The incision length, operation time, intraoperative blood loss, total blood transfusion volume, and hospitalization time of group A were significantly less than those of group B (P<0.05). The patients were followed up 15-48 months (mean, 25.3 months) in group A and 12-51 months (mean, 27.6 months) in group B. The overall incidence of complications related to surgery in group A (10.29%) was significantly lower than that of group B (19.35%) (χ2=8.769, P=0.023). The acetabular anteversion and abduction angle were in the normal range of 2 groups except 1 hip (1.47%) of group A had a higher acetabular anteversion than normal value. Unstable fixed prosthesis happened in 1 hip of groups A and B respectively, and the remaining femoral calcar had no obvious bone resorption and fixed stably. The Harris score and VAS score at each time point after operation of 2 groups were significantly improved when compared with preoperative scores (P<0.05), and the differences between the time points after operation were also significant (P<0.05). The Harris score at 1 and 3 months after operation and the VAS score at 3 days after operation of group A were significantly better than those of group B (P<0.05), but no significant difference was found at last follow-up between 2 groups (P>0.05). According to the simple Likert scale method to analyze patient satisfaction, comprehensive satisfaction of group A (97.1%, 33/34) was significantly higher than that of group B (67.7%, 21/31) (χ2=10.343, P=0.001). Conclusion The application of DAA in one-stage bilateral total hip arthroplasty can significantly relieve the pain, accelerate the recovery of hip joint function, and improve the patient satisfaction. But in clinical application, more attentions should be paid to strictly grasp the indications and prevent the early complications. The long-term effectiveness needs to be further observed.