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.
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.
Objective To evaluate the quality of Chinese clinical practice guidelines published in domestic medical journals in 2011. Methods The following 4 Chinese databases including WanFang Data, VIP, CNKI and CBM were searched from January 2011 to December 2011. The quality of included guidelines was assessed by using AGREE II. Results A total of 75 guidelines published in 2011 were included. Among them, 10 guidelines (13%) stated the conflict of interest, 10 guidelines (13%) mentioned evidence-based developing, 5 guidelines (7%) performed evidence grading system, 8 guidelines (11%) performed recommendation strength grading system, and 4 guidelines (5%) performed both evidence and recommendation strength grading systems. The ratio of the 6 domains’ scores of AGREEⅡ were as follows: scope and purpose (18%), stakeholder involvement (11%), rigour of development (8%), clarity of presentation (34%), applicability (5%), and editorial independence (14%). Conclusion Compared with the guidelines published before, the guidelines of 2011 have a higher quality and some of them are progressively standardized in developing methodology.
Objective To systematically evaluate the efficacy and safety of iris-registration in wavefront-guided LASIK (IR+WG LASIK) versus conventional LASIK for correction of myopia accompanied with astigmatism. Methods Such databases as PubMed, EMbase, The Cochrane library (Issue 2, 2012), CBM, CNKI, VIP, and WangFang Data were searched to collect the randomized controlled trials (RCTs) and quasi-RCTs about IR+WG LASIK versus conventional LASIK for correction of myopia accompanied with astigmatism. The retrieval time was from inception to February 2012, and the language was in both Chinese and English. Two reviewers independently screened the literature, extracted the data and assessed the quality of the included studies. Then the meta-analysis was performed by using RevMan 5.1 software. Results A total of 9 studies involving 3 903 eyes were included. The results of meta-analysis showed that, compared with the conventional LASIK group, the IR+WG LASIK group had a higher ratio in patients with postoperative uncorrected visual acuity no less than 1.0 (RR=1.03, 95%CI 1.01 to 1.05, P=0.002), as well as in patients with best-corrected visual acuity gained over 1 line (RR=1.75, 95%CI 1.49 to 2.16, Plt;0.000 01); it was smaller in the postoperative high order aberration RMS (WMD=−0.16, 95%CI −0.21 to −0.11, Plt;0.000 01), coma-like RMS (WMD=−0.05, 95%CI −0.11 to 0.00, P=0.07), spherical-like RMS (WMD=−0.15, 95%CI −0.23 to −0.07, P=0.000 2), and residual astigmatism (WMD=0.14, 95%CI 0.10 to 0.18, Plt;0.000 01); moreover, it was lower in the incidence of postoperative glare (RR=0.27, 95%CI 0.15 to 0.50, Plt;0.000 1), and it was higher in the subjective satisfaction of patients (RR=1.08, 95%CI 1.04 to 1.13, P=0.000 3). Conclusion Compared with conventional LASIK, IR+WG LASIK can more effectively reduce astigmatism, postoperative high order aberration RMS and spherical-like RMS. It can also get visual function including uncorrected visual acuity and best-corrected visual acuity, consequently increase patient’s satisfaction. But further studies are still required for its long-term effect.
Objective To analyze the methodological quality of clinical practice guideline mentioned “evidence-based” in China. Methods We selected clinical guidelines developed based on evidence issued by the Chinese Medical Association in 2010-2012, and meanwhile, we conducted additional search for guidelines on clinical major diseases. Then, we selected literature according to the inclusion and exclusion criteria and evaluated the included guidelines according to 8 items relevant to methodological rigor which were selected from the Appraisal of Guidelines for Research and Evaluation (AGREE II). If the guidelines comply with the item, we recorded 1 point, otherwise 0 point. Results a) Among twenty-two included guidelines, 13 were originated and 9 were updated once every 3 to 5 years. b) Diseases covered stroke, diabetes, chronic hepatitis B, hypertension, pediatric nutrition, etc. c) The number of guideline references were 10 to 218, of which, nine guidelines cited 24 Cochrane systematic reviews (CDSRs), accounted for 2.62% (24/916). Among them, the acute ischemic stroke guideline cited the most (7 CDSRs). d) The number of experts involved in guidelines development was 2 to 95 and guidelines pages were 4 to 150. e) The guidelines’ quality generally scored 4 to 7, most of which described the process of guidelines development. The grades of recommendation were consistent with the levels of evidence. But most of the included guidelines did not clearly described literature research methods, peer reviewer, and update procedures. Conclusion There is a growing trend that clinical guidelines are developed based on evidence in China. However, the quality of reporting and the methodological rigor of guidelines need further improvement. The citation rates of Cochrane systematic reviews in these guidelines were relatively low. We suggest that guideline recommendations should be consistent with the levels of evidence and adapt to local conditions, and relevant support policies for guideline implementation in practice. In future, attention should be paid to the aspects of guideline development methods, reporting standard, guideline accessibility, and standard training for relevant personnel.
The shortage of health workforce in rural and remote areas has been commonly concerned by every country around the word. It is one of world health issues, challenging the aspirations of achieving equity. In this regard, WHO developed the Global Policy Recommendations to improve the accessibility of the health workforce in rural and remote areas through improved retention. This article focuses on the key steps of the policy guideline developed from evidence-based medicine methodology and from angle of guideline development, mainly about background, issues, evidence retrieval and selection, quality grading of evidence, and the forming of recommendation plan, in order to further explore how to correctly understand, obtain, evaluate and apply currently available research evidence, and how to use the GRADE system to make scientific and feasible recommendations in the decision-making process, emphasizing the importance of evidence and the GRADE system in the evidence-based health decision-making.
To overview the methodology and procedure used in developing evidence-based guidelines for migraine headache, the article described the two procedures systematically: 1. the Methods used in the Agency for Health Care Policy and Research’s Technical Reviews. 2. US Headache Consortium’s Methods used in developing clinical guidelines
Objective To improve care and outcomes for all migraine suffers, the USHC created these evidence-based guidelines for migraine headache. Methods Firstly, 5 relative Technical reviews were done according to the Methods used in the AHCPR Technical Reviews. Secondly, based on the results of the 5 technical reviews, the 4 treatment guidelines were developed in direction of the USHC’S Methods used in developing clinical guidelines. Results Evidence supporting the acute treatment and preventive treatment were exclusively Class 1 studies, evidence supporting the diagnostic testing were either Class 2 or Class 3 studies , only very few expert judgment was given on some compelling issues without evidence. The recommendations they supporting were high-qualified, middle-qualified, and poor-qualified respectively. Conclusion This Evidence-Based Guidelines is one of the first and most extensive cooperative projects available for creating guidelines. The guideline was developed with systematical and scientific methods and stroven to base all of its recommendations on evidence.
摘要:目的：探讨超声引导下组织间插植内照射治疗中晚期宫颈癌的意义和效果。方法:回顾性分析32例中晚期宫颈癌患者,采用超声引导下肿瘤组织间插植内照射+外照射。结果：有23例肿瘤脱落,宫颈原形出现,其余7例肿瘤缩小50%以上,持续时间均≥1个月,另有2例肿块缩小＜50%,即CR为719%,PR为218%,NC为63%,PD为0%。结论：超声引导下插植内照射是一种治疗中晚期宫颈癌的安全有效的近距离放疗技术。Abstract: Objective: To evaluate the efficacies of interstitial implant brachytherapy by ultrasoundguided for moderately advanced and advanced cervical carcinoma. Methods: Thirytwo patients with cervical cancer ⅡbⅣ who received interstitial implant brachytherapy by ultrasoundguided and routine irradiation. Results: 719% cases achieved complete remission (CR), 219% cases partial remission (PR), 63% cases no change(NC),0% case progressed disease（PD）. Conclusion: Interstitial implant brachytherapy by ultrasoundguided is an effective method for cervical tumor.
Abstract： Objective To explore the approach of clinical diagnosis and treatment strategy for patients with small pulmonary nodules （SPN）≤ 1.0 cm in size on CT. Methods We retrospectively analyzed the clinical records of 39 patients with SPN less than 1.0 cm in size who underwent lung resection at Nanjing Drum Tower Hospital from January 2005 to June 2011. There were 23 males and 16 females. Their age ranged from 31-74 （51.0±7.4） years. Nine patients had cough and sputum and other patients had no symptom. All the patients were found to have SPN less than 1.0（0.8±0.1）cm in size but not associated with hilum and mediastinal lymphadenectasis in chest CT and X-ray. The results of their sputum cytology and electronic bronchoscope were all negative. All the patients had no histologic evidence and underwent pulmonary function test prior to operation. Eleven patients had positron emission tomography/computer tomography （PET/CT）or single-photon emission computed tomography （SPECT）which was all negative. Thirteen patients underwent video-assisted minithoracotomy（VAMT） and 26 patients underwent video-assisted thoracoscopic surgery （VATS）. Results The average operation time was 121.0±48.0 min. Patients after partial lung resection were discharged 4～5 d postoperatively, and patients after lobectomy were discharged 7 d postoperatively. All the patients had no postoperative complications. Twenty one patients were identified as lung malignancy by postoperative pathology, including 9 patients with adenocarcinoma, 7 patients with bronchioloalveolar carcinoma, 1 patient with small cell lung carcinoma, and 4 patients with pulmonary metastasis. Eighteen patients had benign lesions including 4 patients with sclerosing hemangioma, 4 patients with inflammatory pseudotumor, 2 patients with pneumonia, 3 patients with granuloma, 2 patients with tuberculosis, and 3 patients with pulmonary lymph node hyperplasia. The SPN were located in left upper lobe in 11 patients, left lower lobe in 6 patients, right upper lobe in 14 patients, right middle lobe in 1 patient, and right lower lobe in 7 patients. Conclusion The diagnosis of SPN ≤1.0 cm in size on CT should consider malignance in the first step to avoid treatment delay. Patients may have a 3-month observation period to receive selective antibiotic treatment, chest CT and X-ray review after 2 to 4 weeks. CT- guided hook-wire fixation is useful to help in precise lesion localization for surgical resection. VATS and VAMT are common and effective methods for the diagnosis and treatment for SPN.