To assess the rel iabil ity of diabetic cutaneous ulcer surface area (DCUSA) measurement usingdigital planimetry method (A) and transparency tracing method (B). Methods Images of diabetic cutaneous ulcers from35 inpatients with diabetic skin ulcers from September 2005 to April 2007 were taken by a digital camera once a week or twice a week over a period of 12 weeks, resulting in 305 photographs; the ulcers were traced on a grid with acetate wound tracings, simultaneously. A total of 305 pairs of DCUSA which were calculated respectively throughout digital camera combined with Image J medical imaging software and transparency tracing with grid sheet by two independent observers sequentially were obtained. The intraclass correlation coefficients (ICCs, one-way random effect model) was used as an indicator of chancecorrected agreement to estimate the relative rel iabil ity for the interobserver data. Multiple l inear regression analysis was also used to measure the relationship of these two methods. Results DCUSA obtained from method A and obtained from method B was (4.84 ± 7.73) cm2 and (5.03 ± 7.89) cm2, respectively; no significant difference was found (P gt; 0.05). ICCs was high (ICCs=0.949 for method B and 0.965 for method A), indicating that the relative rel iabil ity for the interobserver was excellent. The method A were highly correlated with measurements obtained from method B (r = 0.957, P lt; 0.05). Conclusion The digital planimetry method described in this study represents a simple, practical, without any wound damage and contamination, and inexpensive technique to accurately evaluate the areas of diabetic cutaneous ulcers. The photographic technique combined with Image J medical imaging software should be considered for wound measurement.
Sharing clinical trial data can increase the transparency of clinical trials and improve the its authenticity. The current requirements of clinical research data transparency is not fully adequate, and it is still difficult to create an environment in which the sharing of the clinical trial data becomes the norm. The article analyzed various concerns on data sharing and proposed solutions in data ownership, technology, implementation, and legal issues systematically, calling for clinical trial data sharing in order to promote transparency of clinical trials, and looking forward to minimize the risks and maximize the benefits of data sharing.
The concept of clinical trial transparency has been promoted for more than 40 years. The act of clinical trial registration, report guidelines development, and data sharing has has been strongly pushed forward and become a common practice. The clinical trial process being the key procedure of trial operation and quality control, determines the accuracy of the results. However, the process report of clinical trials is insufficient. In this article, we summarize the importance of clinical trial process report and provide corresponding suggestions. We propose that medical journals, reporting guidelines developers and clinical trial registration platforms should work together to strengthen the process report of clinical trials and promote full transparency of clinical trials.
Data integrity, accuracy, and traceability are key elements of high-quality clinical research, as well as weak links in the promotion of clinical research transparency. How to promote data quality has become a major concern to all clinical research stakeholders. In this article, we dissected and analyzed data generation and capturing process in clinical research, and identified a key aspect in improving data quality: to promote electronic source data, especially to break the barrier between electronic health records and clinical research systems. Additionally, we summarized the experiences regarding this issue in China and overseas to propose a solution suitable for China to improve data quality in clinical research: to strengthen clinical research source data management by building clinical research source data platform and adopt common source data management process in hospitals.
ObjectiveTo develop a transparent evaluation tool for the transparency of clinical practice guidelines.MethodsLiterature, books and policy documents related to the transparency of guidelines were retrieved from PubMed, EMbase, Web of Science, WanFang Data and CNKI databases to form a pool of items. After two rounds of Delphi expert consultation, the items were modified and scored to determine whether to be included in the final evaluation system. Expert consensus would determine the organization and evaluation method of the final tool.ResultsA total of 77 references were included, and 399 items related to transparency of guidelines were extracted. The items pool containing 53 items was formed after normalization and de-duplication. After two rounds of Delphi consultation, the evaluation tool for transparency of clinical practice guidelines covering 32 items in 6 areas was formed. The established tool consisted of planning (5 items), personnel selection (6 items), conflict of interest management (6 items), recommendation formation process (8 items), external review process (3 items), and guide reporting process (4 items).ConclusionsThe developed evaluation tool for transparency of clinical practice guidelines can provide a standard for the formulation, evaluation and utilization of guidelines from the perspective of transparency.
ObjectiveTo develop a transparency evaluation tool 2.0 of clinical practice guidelines (CPGs) oriented by public trust. MethodsThe Delphi method was employed to score and select the importance and operability of evaluation indicators. The analytic hierarchy process was used to determine the weights of the indicators. And the final evaluation indicator system was determined through expert consensus meeting. ResultsIt constructed two first-level indicators including conflict of interest and formulation process, and six second-level indicators, including guideline developers, reviewers, protocol and registration, evidence production, recommendation formation, and external review. Based on the second-level indicators, a total of 21 third-level indicators were constructed from the perspectives of disclosure and management. The logical structure of the tool is rigorous and harmonious. ConclusionThe CPGs transparency assessment tool 2.0 developed in this study provides measurement standards and an evaluation framework for assessing transparency in CPGs.