Authors and presenters are responsible for how medical research is interpreted and communicated. Often their work is the product of collaborations with other individuals (such as clinical investigators, biostatisticians, and professional medical writers) from around the world. Some or all of the people who contribute to this collaboration may be employees of research sponsors, contract research organisations, or medical communications agencies that may be funded by pharmaceutical, medical device, or biotechnology companies. The authors, collaborators, and organisations share responsibility for developing articles and presentations in a responsible and ethical manner.The good publication practice (GPP2) guidelines presented here make recommendations that will help individuals and organisations maintain ethical practices and comply with current requirements when they contribute to the communication of medical research sponsored by companies. These guidelines apply to peer reviewed journal articles and presentations at scientific congresses. evolving standardsThe conduct and communication of medical research, including that sponsored by companies, continues to be criticised.

OBJECTIVE -To compare pre-and postmeal capillary blood glucose concentrations measured at the finger, forearm, and thigh in adults with diabetes.RESEARCH DESIGN AND METHODS -For phase 1, capillary blood glucose concentrations were measured at six time points (premeal and at ϳ60, 90, 120, 150, and 180 min postmeal) using a blood glucose monitoring system and technician-obtained samples collected from finger, forearm, and thigh sites of 42 adults with diabetes. The finger samples were also tested with a laboratory instrument. For phase 2, ϳ14 weeks later, the testing procedures were repeated with 38 subjects from the original study population.RESULTS -Meter finger results were accurate at all time points. Alternate sites tended to produce lower glucose readings compared to finger readings at times when glucose was increasing rapidly (60 and 90 min postmeal). Forearm-to-finger differences correlated with rates of glucose change (r ϭ 0.56, P Ͻ 0.001), as did the thigh-to-finger differences (r ϭ 0.52, P Ͻ 0.001). Other factors, such as subject age, BMI, diabetes type, and insulin dependence did not have a significant impact on site differences. When the testing procedures were repeated with the same subjects, the pattern of site differences was consistent, although individual results were variable.CONCLUSIONS -Changes in blood glucose immediately after a meal may be identified at finger sites before detection at forearm or thigh sites. Alternate site testing appears to be a useful option for routine self-monitoring before meals; however, patients and clinicians should recognize that results may be different from fingertip results when glucose levels are changing rapidly. Diabetes Care 25:961-964, 2002

OBJECTIVETo assess the implications of falsely elevated glucose readings measured with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) test strips.RESEARCH DESIGN AND METHODSWe conducted a review of the Food and Drug Administration's Manufacturer and User Facility Device Experience database and medical literature for adverse events (AEs) associated with falsely elevated glucose readings with GDH-PQQ test strips in the presence of interfering sugars.RESULTSEighty-two reports were identified: 16 (20%) were associated with death, 46 (56%) with severe hypoglycemia, and 12 (15%) with nonsevere hypoglycemia. In eight reports (10%), the AE was not described. Forty-two events (51%) occurred in the U.S. Although most events occurred in hospitalized patients, at least 14 (17%) occurred in outpatients. Agents most commonly associated with AEs were icodextrin-containing peritoneal dialysate and maltose-containing intravenous immune globulin.CONCLUSIONSGDH-PQQ test strips pose a safety risk to insulin-using patients treated with agents containing or metabolized to interfering sugars.

Results: A total of 52 reports met our inclusion criteria and were reviewed. None (0%) of the reports conformed to all 38 STARD and CLSI recommendations. The range of compliance to these recommendations varied widely (median 53%; range 21%-84%). Only 1 study of the 52 reported following a CLSI recommendation for checking reference test results. Fewer than half (42%) of the reports contained STARD-recommended statements regarding how and when comparative measurements were performed. Conclusions: None of the glucose monitor reports from our review conformed to all STARD and CLSI recommendations. Our finding that the average rate of compliance to recommendations was low suggests that many of the researchers did not follow published recommendations for study design, methodology, and reporting and that study quality and conclusions may have been affected. Future studies evaluating the performance of glucose monitoring systems should be carefully designed and follow published recommendations for methodological and reporting quality.

We propose a standardized 14-step checklist that facilitates the incorporation of international consensus standards, quality guidelines, and acceptance criteria into the design and reporting of glucose monitor evaluation protocols.