Objective To study the USA government’s administrative system about medical device standards as well as the standard making. Methods The relevant documents, regulations, website that USA Food and Drug Administration announced were extensively reviewed, knowing the USA medical device standards synthetically. Results The USA standards system of medical device included regulatory requirements and voluntary consensus standards. This article simply introduced the laws, regulations, performance standards and consensus standards. Conclusion The USA’s administrative system about medical device standards as well as many standards can be referenced.
Fullfield electroretinalgraphy (ffERG) is an indispensablemeans in assessment of retinal disease; it is invasive, effective, objective, quantifiable, and reproducible. Currently ffERG has been extensively applied domestically, but it also has disadvantages such as too few detected diseases, nonstandardised methodology, and inaccurate description of the results. It is important to place more emphasis on the internationalization, standardisation, and normalization of the application; obtaining the differences of indication, detection techiniques, and description of the results among ffERG, multifocal ERG and pattern ERG; expanding the new fields and methods of clinical applications. So that ffERG could play an more important role in the diagnosis and management for the patients with retinal disease.
Objective To verify the effects of the treatment of krypton yellow laser for diabetic macular edema.Methods A total of 430 eyes in 251 cases of diabetic focal macular edema, diffuse edema and cystoid edema were treated with krypton yellow laser photocoagulation. Those with focal macular edema underwent the focal photocoagulation, and those with diffuse edema and cystoid edema underwent the grid photocoagulation.The visual acuity examination, fundus fluoresec in angiography and colour photography of the fundus were performed before and every 3 or 4 months after the treatment.The changes of macular edema after the treatment were analysed.The follow-up duration was 3 to 23 months (with an average of 15.5 months). Results After laser focal photocoagulation in 186 eyes with focal macular edema, visual acuity was improved or maintained in 183 eyes (98.39% ). Edema disappeared completely or partially in 184 eyes (98.93%). After laser grid photocoagulation in 175 eyes with diffuse macular edema, visual acuity was improved or maintained in 163 eyes (93.14%). Edema disappeared completely or partially in 164 eyes (93.71%). After laser grid photocoagulation in 69 eyes with cystoid macular edema, visual acuity was improved or maintained in 59 eyes (85.5% ). Edema disappeared completely or partially in 64 eyes (92.75%).Conclusion The linchpin of the treatment of krypton yellow laser for diabetic macular edema lies in the insurance of the effective laser macules and the adaptability of selecting the proper parameter of laser according to the degree and scope of the macular edema and the visual acuity. (Chin J Ocul Fundus Dis，2003，19：14-17)
Objective To investigate the clinical characteristics of prepapillary and preretinal vascular loops. Methods The clinical manifestation, results of the fundus fluorescein angiography, and the prognosis of 20 cases(24 eyes) with prepapillary and preretinal vascual loops were analyzed retrospectively. Results 66.7% of prepapillary and preretinal vascular loops were involved in one eye, and 95.8% of vascular loops were located within one optic disc diameter. There were different configuration types of the vascular loops. Among 20 cases(24 eyes) of the vascular loops, 70.8%(17 eyes) were arterial, 12.5%(3 eyes) were venous, and 16.7%(4 eyes) were both arterial and venous. 62.5% of eyes with prepapillary and preretinal vascular loops were associated with other congenital and developmental anomalies of retinal vascular vessels. Conclusion Most PRVL are arterial and superior to the optic disc. The serious distortion of the vascular loops may result in disturbance of blood flow in artery and retinal hemorrhage, which cause visual loss. (Chin J Ocul Fundus Dis, 1999, 15: 9-11)
Purpose To investigate the blood dynamic feature of choroid in normal eyes. Methods Indocyanine green angiography (ICGA) was performed in each of fifty consecutive normal eyes. Results The earliest fundus fluorescence emerged at the mean timiest fundus fluorescence emerged at the mean time of (14.25plusmn;3.59) seconds,it represented the beginning of filling of choroidal arteries located at the posterior pole.The irrigation of choroidal veins appeared at the mean time of (15.03plusmn;3.44) seconds.At the time threre was the overlapping imaging appearance of choroisal arteries and veins.The most hyperfluorescent areas appered at the mean time of(16.75plusmn;3.78) seconds with definite shapes located at the posterior pole,and this stood for the fluorescence stage of choroidal arteries,veins and capillaries.The fluorescence of choroidal vein began to weaken at 11prime;58Prime;15plusmn;2prime;39Prime;86,and revealed the imaging of late stage of choroidal veins.The latest stage of ICGA was at 22prime;13Prime;22plusmn;3prime;30Prime;55,and presented obscure fluorescence. Conclusion The measurement results and fluorescent features of ICGA of normal eyes can offer consulted bases for the clinical diagnosis of the choroidal diseases. (Chin J Ocul Fundus Dis,1998,14:68-71)
Objective To assess the quality of the published randomized controlled trials published in Journal of Beijing University of Traditional Chinese Medicine (JBUTCM), Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai (AUTMSPS), Journal of Guangdong University of Traditional Chinese Medicine (JGUTCM), and Journal of Chengdu University of Traditional Chinese Medicine (JCUTCM) from 2000 to 2005. Method Guided by the Cochrane Center hand-searching guidelines, we searched 24 volumes (111 issues) of the four journals. The data were extracted according to the principles of clinical epidemiology and consolidated standards of reporting trials (CONSORT), as well as an evaluation scale for randomized controlled trials (RCTs). The data were managed by descriptive analysis and uniformity test. Results There were 365 RCTs. The diagnostic criteria were reported in 297 trials (81.37%). The inclusion and exclusion criteria were reported in 143 trials (39.18%) and 132 trials (36.16%), perspectively, None mentioned the estimation of sample size. The randomization and allocation concealment were reported in 70 trials (19.18%) and 9 trials, perspectively. The baseline data were described in 292 trials (80.00%). Blinding was mentioned in 35 trials (9.59%).Withdrawal occurred in 20 trials (5.48%). Informed consent was acquired in 2 trials. Adverse drug reactions were described in 97 trails (26.58%). Conclusion There are deficiencies in the reporting of these RCTs, Most of the trials do not describe the randomization, only a few trials use the allocation concealment and blinded method, no description of comparability of baseline data, most of the trials do not report the inclusion and exclusion criteria, and none estimate the sample size. These problems indicate that it is necessary to improve the quality of clinical research in Chinese medicine and pharmacology.
As a tool for building consensus among groups, Delphi technique has been widely used in healthcare research which is appropriate for clinical questions where quantitative methods are unlikely to yield results that can be successfully implemented in practice. Researchers in palliative care developed standards for conducting and reporting Delphi studies (CREDES). This paper introduces and interprets the specific content of CREDES standards, with a view to providing reference for the evaluation of Delphi research design quality and report transparency.
Poland syndrome is a congenital anomaly characterized by unilateral underdeveloped or absent chest wall, accompanied by varying degrees of ipsilateral limb defects. In clinical practice, Poland syndrome is prone to misdiagnosis and missed diagnosis, which delays treatment timing and affects treatment effectiveness, as the current etiology is not yet clear and there is no unified and standardized clinical classification and treatment plan. This article summarizes and elaborates on the etiology, clinical manifestations, classification, diagnosis, and treatment of Poland syndrome by reviewing relevant literature on the diagnosis and treatment of Poland syndrome both domestically and internationally in recent years, in order to enhance understanding of Poland syndrome, provide reference for standardized clinical diagnosis and treatment, and improve the efficiency of diagnosis and treatment.
Digital health technology implementation has grown rapidly in recent years. To standardize the quality of digital health implementation research and increase the transparency and integrity of reporting, Perrin published iCHECK-DH: guidelines and checklist for the reporting on digital health implementations in 2023. This article interprets the contents of the list with a view to improving the reporting quality of digital implementation studies to develop more effective digital health interventions and achieve better health outcomes.