Rapid development of recently emerging precision medicine techniques represented by gene therapy has brought hope for the treatment of rare blinding eye diseases such as inherited retinal diseases (IRDs) for which there was no effective treatment previously. Although the globally growth of clinical trials for IRDs has increased rapidly over the past decade, due to the highly genetic and clinical phenotypic heterogeneity, as well as limited data on epidemiology and natural history of the disease, along with severe loss of vision function of majority patients for which the established measurements may not be appropriate, such studies lack standard outcome measurements and endpoints to asses clinical meaningful effectiveness, posing great challenges in terms of study design and evaluation of treatment efficacy, as well as clinical practice application. At present, there is no systematic nor standardized guidance on safety measures, clinical outcomes and endpoints of visual function for clinical trial design in IRDs. Therefore, in order to standardize the validated evaluation of IRDs clinical efficacy outcome measurements and endpoints, the Fundus Disease Group of Chinese Medical Association Ophthalmology Branch and Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch organized domestic experts to put forward consensus and recommendations on standardizing outcome measurements and endpoints for clinical study design in IRDs, aiming to advance the study design of IRDs natural history research and clinical trials and to effectively evaluate disease progression and intervention efficacy. Along with the development of medical science and clinical trials, relevant content will be improved and updated accordingly.
Inherited retinal diseases (IRDs) are a group of severe retinal degenerative diseases leading to permanent visual impairment. IRDs are the major cause of irreversible blindness in children and working age groups. Gene therapy is a new clinical treatment method and currently the only clear and effective treatment for IRDs, while, there are still risks in clinical research and application. How to standardize perioperative management and reduce the potential risks of treatment is one of the keys to ensure the safety and effectiveness of treatment. However, there is no systematic and standardized guidance on the perioperative management for IRDs gene therapy. Therefore, in order to standardize the perioperative management, the Fundus Disease Group of Ophthalmology Society of Chinese Medical Association and Chinese Medical Doctor Association organized domestic experts to put forward standardized opinions on the perioperative management of IRDs gene therapy in China after repeated discussion and combined with domestic and foreign research experience, so as to provide clinicians with reference and application in clinical research and practice.
ObjectivesTo assess the methodological quality of clinical practice guidelines of cervical cancer in China published from 2014 to 2018.MethodsCNKI, WanFang Data, CBM, VIP, Medlive.cn, the National Guideline Clearinghouse, PubMed, The Cochrane Library and EMbase were searched for cervical cancer clinical practice guidelines published in China from January 1st, 2014 to December 31st, 2018. Four reviewers searched and selected the literature independently according to the inclusion and exclusion criteria and assessed the methodological quality of the included guidelines by using AGREE Ⅱ.ResultsA total of 9 guidelines were included. The average score for each area was: scope and purpose 75.47%, stakeholders’ involvement 35.09%, the rigor of development 43.70%, clarity of presentation 87.74%, applicability 80.76%, and editorial independence 0%.ConclusionsThe quality of cervical cancer clinical practice guidelines in China requires further improvement.
ObjectiveTo investigate the effectiveness of digital three-dimensional (3D) printing osteotomy guide plate assisted total knee arthroplasty (TKA) in treatment of knee osteoarthritis (KOA) patients with femoral internal implants. Methods The clinical data of 55 KOA patients who met the selection criteria between July 2021 and October 2023 were retrospectively analyzed. Among them, 26 cases combined with femoral implants were treated with digital 3D printing osteotomy guide plate assisted TKA (guide plate group), and 29 cases were treated with conventional TKA (control group). There was no significant difference in gender, age, body mass index, side, Kellgren-Lawrence classification, preoperative visual analogue scale (VAS) score, Hospital for Special Surgery (HSS) knee score, knee range of motion, and other baseline data between the two groups (P>0.05). The operation time, intraoperative blood loss, incision length, postoperative first ambulation time, surgical complications; VAS score, knee HSS score, knee range of motion before operation, at 1 week and 3 months after operation, and at last follow-up; distal femoral lateral angle, proximal tibial medial angle, hip-knee-ankle angle and other imaging indicators at last follow-up were recorded and compared between the two groups. ResultsThe operation time, incision length, intraoperative blood loss, and postoperative first ambulation time in the guide plate group were significantly lower than those in the control group (P<0.05). In the control group, there were 1 case of incision rupture and bleeding and 1 case of lower limb intermuscular venous thrombosis, which was cured after symptomatic treatment. There was no complication such as neurovascular injury, incision infection, or knee prosthesis loosening in both groups. Patients in both groups were followed up 12-26 months, with an average of 16.25 months. The VAS score, HSS score, and knee range of motion improved at each time point after operation in both groups, and further improved with time after operation, the differences were significant (P<0.05). The above indicators in the guide plate group were significantly better than those in the control group at 1 week and 3 months after operation (P<0.05), and there was no significant difference between the two groups at last follow-up (P>0.05). At last follow-up, the distal femoral lateral angle, the proximal tibial medial angle, and the hip-knee-ankle angle in the guide plate group were significantly better than those in the control group (P<0.05). Conclusion The application of digital 3D printing osteotomy guide plate assisted TKA in the treatment of KOA patients with femoral implants can simplify the surgical procedures, overcome limitations of conventional osteotomy guides, reduce surgical trauma, achieve individualized and precise osteotomy, and effectively restore lower limb alignment and knee joint function.
The selection of outcome measurement instruments (OMI) is a prerequisite for accurately collecting health outcome data. Conducting a systematic review of OMI can provide an important reference for researchers and practitioners to select the most appropriate OMI. In order to improve the reporting quality of the systematic review of OMI, foreign researchers published the PRISMA-COSMIN reporting guideline in the J Clin Epidemiol in June 2024. This article introduces the research team, development process, and items of the reporting guideline, and analyzes the items with examples. We hope our attempt could help domestic researchers improve the overall quality of OMI systematic reviews.
ObjectivesTo systematically review the efficacy and safety of ultrasound-guided percutaneous microwave ablation versus traditional open surgical operation in the treatment of benign thyroid nodules.MethodsPubMed, The Cochrane Library, EMbase, CBM, CNKI and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on ultrasound-guided percutaneous microwave ablation versus traditional open surgery for benign thyroid nodules from inception to June 30th, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was then performed by RevMan 5.3 software.ResultsA total of 38 RCTs involving 4 078 patients were included. The results of meta-analysis showed that: ultrasound-guided percutaneous microwave ablation might be more effective than traditional open surgery for the treatment of benign thyroid nodules (RR=1.09, 95% CI 1.00 to 1.19, P=0.04), and compared with traditional open surgery, ultrasound-guided percutaneous microwave ablation reduced the rate of postoperative complication (RR=0.26, 95%CI 0.21 to 0.31, P<0.000 01), shortened postoperative hospital stay (MD=–3.60, 95%CI –4.04 to –3.15, P<0.000 01) and the time consumed in operation (MD=–48.79, 95%CI –54.16 to –43.41, P<0.000 01), and reduced operative blood loss (MD=–22.02, 95%CI–23.87 to –20.17, P<0.000 01). Meanwhile, microwave ablation reduced the elevated levels of serum IL-6 content (MD=–10.34, 95%CI –10.70 to –9.97, P<0.000 01), serum CRP content (MD=–9.70, 95%CI –10.95 to –8.44, P<0.000 01) and serum TNF-α content (MD=–7.94, 95%CI –9.00 to –6.88, P<0.000 01).ConclusionsCurrent evidence shows that ultrasound-guided percutaneous microwave ablation may improve clinical efficacy and can reduce postoperative complications, bleeding volume, operation time, hospitalization days and postoperative inflammatory reaction. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
Objective To explore the methods used for developing evidence-based clinical practice guidelines for acupuncture. Methods Based on the characteristics of acupuncture in traditional Chinese medicine,and principles of evidence-based medicine, this article introduces and summarizes the processes and methods for developing an evidence-based clinical practice guideline for acupuncture. We analyzed similarities and differences between clinical practice guidelines for acupuncture and for other interventions. We used an evidence-based clinical practice guideline of acupuncture for depression as an example to illustrate the methods of literature search, grading of evidence and recommendations, evidence evaluation and consensus formation. Results Preliminary recommendations on the methods for developing evidence-based clinical practice guidelines for acupuncture were made. Conclusion Based on the optimized rational methodology for developing clinical guidelines, evidence-based high-quality clinical practice guidelines for acupuncture could be established.
Objective To summarize and compare the functional characteristics and technical parameters of the comprehensive global clinical practice guideline (CPG) databases, so as to provide references for the construction of CPG database of China. Methods CPG databases were collected worldwide by discussing with experts in the guideline and database fields. Studies on guideline databases were searched in PubMed and CNKI to additionally collect CPG databases mentioned in these studies. Representative comprehensive CPG databases were finally selected by consulting relevant guideline experts. The basic information, functional characteristics (including column settings, service contents, and related file types) and technical parameter data were extracted and summarized. A descriptive analysis was conducted to compare different CPG databases. Results Nine guideline databases which are distributed in eight countries of the Americas, Europe, Oceania and Asia were included. The number of included guidelines of the nine databases ranged from 31 to 15 410. The earliest database was established in 1993. Except that the MINDS database didn’t provide search function, eight databases provided basic search function, and six provided further advanced search function. PDF and HTML formats of guidelines were available in most databases, but the XML format was only available in National Guideline Clearinghouse (NGC). Responsive Web design was an important feature for most websites of databases and four databases developed mobile applications. Local mainstream social media sharing function was provided by six databases. All databases’ construction was professional in technical parameters including network transmission, Web server, programming language and the selection of server room. Conclusion This study compares the functional features and technical parameters of the comprehensive global CPG databases, which provides important information that should be considered in establishing a guideline database, to strengthen the top-level design or to help optimize the functionality of a guideline database. It also helps guideline databases users to find more proper resources.
Kangaroo mother care has reduced mortality and morbidity in preterm and low birth weight infants and has many benefits, such as promoting breastfeeding. Based on the current evidence in China and internationally, we developed clinical practice guidelines for kangaroo mother care in preterm and low birth weight infants using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE), and proposed 34 recommendations for 20 key questions. Our goal is to promote the appropriate implementation of kangaroo mother care in clinical practice.