PubMed · 15763899
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A Kemal Oguz. 2005. Do we speak the same language for ITP?. https://doi.org/10.1080/09537100400004322
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In Germany, germ cell tumors are characterized by a marked excess mortality, i.e. a discrepancy between the actual mortality and the mortality expected with adequate implementation of the standard therapy. Moreover, Germany not only has a significantly increased mortality in an international comparison but also shows marked regional differences in the quality of medical care. This is partly due to difficulties in implementing the standard therapy. An attempt was made to improve the quality of medical care by setting up evidence-based diagnostic and therapeutic guidelines in 1996. Contrary to expectations, however, these guidelines have thus far remained largely ineffective, their implementation being hampered by a solely passive dissemination strategy. Added to this are inadequate medical care structures in which the guidelines cannot be properly implemented because of the organizational, social and professional context. Decisive for a quality improvement in the diagnosis, therapy and care of germ cell tumor patients is active dissemination of the guidelines supplemented by a change in the care structure. It is also important to establish indicators for measuring the success of guideline implementation and to perform continuous progress monitoring in order to specifically overcome evident barriers. Future research is required to create a better theoretical basis and to develop further strategies for guideline dissemination and implementation.
OBJECTIVE: Applicability of randomized controlled clinical trial (RCT) results to 'real world' situations is dependent on the comparability of trial participants to general patient populations. A full disclosure of criteria employed for trial enrollment is necessary for clinicians to assess generalizability. We sought to assess both the impact on generalizability and the disclosure rate of enrollment criteria for 32 major HIV RCTs in the AIDS Clinical Trial Group (ACTG) and Community Programs for Clinical Research on AIDS (CPCRA) trial networks. DESIGN AND METHODS: Eligibility criteria were compared in complete protocols to criteria listed in publications from these 32 NIH-funded HIV RCTs. We then applied these criteria to the Women's Interagency HIV Study (WIHS), the largest cohort study of HIV-infected women in the US. RESULTS: When applied to WIHS, eligibility criteria from protocols excluded 0-67.6% (median 42%) of WIHS participants (50.6% excluded from ACTG trials). Eligibility criteria in publications excluded 0-62% (median 19.6%) of WIHS (21.2% excluded from ACTG trials). The number of women in WIHS seemingly ineligible for trial participation per enrollment criteria listed in publications averaged only 60% of those actually excluded based on the protocols. CONCLUSIONS: We found that HIV RCT eligibility criteria excluded a large proportion of a representative cohort of HIV-infected women from trial participation. Furthermore, trial publications are not fully reflective of protocols in terms of disclosing eligibility criteria. Standardization and full disclosure of trial methodology will allow clinicians and researchers to more fully assess the generalizability of findings to their patient populations.
PURPOSE: An insulin infusion protocol for critical care units is described. SUMMARY: Evidence that aggressive glycemic control improves outcomes led physicians, nurses, dietitians, and pharmacists at a trauma center to develop an insulin infusion protocol. Before the protocol, elevated blood glucose concentrations were often not treated until they reached 200 mg/dL or higher. Insulin infusions were underutilized and were often not started until capillary blood glucose concentrations were greater than 350 mg/dL for 12 or more hours. When orders for an insulin infusion were written, they did not include directions for dosage adjustment, and the goal blood glucose range varied. A preliminary protocol was drafted allowing adjustments in insulin administration to be based on changes in capillary blood glucose values since the previous blood glucose measurement. The protocol was presented to a multidisciplinary team and further refined. The targeted blood glucose concentration range was 80-130 mg/dL. After the targeted range was achieved for a patient, if the blood glucose level continued to decrease over three consecutive measurements, the infusion rate was decreased by 0.5 or 1 unit/hr, depending on the capillary blood glucose level. Data for the first 30 patients were collected from September 2003 to August 2004. It took 2-36 hours (mean, 12.6 hours) to bring the capillary blood glucose concentration to less than 130 mg/dL. Among 2,845 capillary blood glucose measurements, there were 15 cases of hypoglycemia (0.4%) requiring treatment with 50% dextrose injection. CONCLUSION: A multidisciplinary effort resulted in the development of an insulin infusion protocol for use in critical care units.