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    STUDY LEVELS OF EVIDENCE (LOE)                                                            events, and the reporting of results
    From the Centre for Evidence-Based                Tight Glycemic                          was sufficient to calculate individ-
    Medicine, Oxford. For the most up-to-             Control May Decrease                    ual event rates. Please note that
    date levels of evidence, see www.cebm.
    net/levels_of_evidence.asp)                       Cardiovascular End                      they excluded 6 large trials because
                                                      Points in Patients With                 cardiovascular events were not part
    Therapy/Prevention/Etiology/Harm:                 Type 2 Diabetes Mellitus                of the primary study outcomes or
    1a: Systematic reviews of randomized                                                      because the original papers did not
         controlled trials                            Clinical Question                       report individual event rates. Since
    1b: Individual randomized controlled                 Does tight glycemic control          there were only 5 studies included
    1c: All or none randomized controlled
                                                      decrease the rate of cardiovascular     (33 000 patients), this is a big con-
         trials                                       complications in patients with type     cern. Some analysts would have
    2a: Systematic reviews of cohort studies          2 diabetes mellitus?                    contacted authors to obtain missing
    2b: Individual cohort study or low-                                                       data. Additionally, if cardiovascular
         quality randomized controlled
                                                      Bottom Line                             event rates are measured in a com-
    2c: “Outcomes” research, ecological
         studies                                          If the authors of this systematic   parable manner, it shouldn’t matter
                                                      review have captured all the rele-      if these were primary or secondary
    Diagnosis:                                        vant studies, tight glycemic control    end points. In the studies the authors
    1a: Systematic review of level-1                  decreases the rate of cardiovascular    chose to include, the overall rate of
         diagnostic studies                           complications in patients with type     nonfatal myocardial infarctions was
    1b: Independent blind comparison
         of an appropriate spectrum
                                                      2 diabetes mellitus. There is strong    10 per 1000 patient-years in inten-
         of consecutive patients, all of              reason to believe, however, that by     sively treated patients compared
         whom have undergone both the                 excluding studies in which cardio-      with 12.3 in control patients. The
         diagnostic test and the reference
         standard, or a clinical decision rule
                                                      vascular outcomes were secondary,       rate of coronary events was 14.3
         not validated on a second set of             and by relying solely on the pub-       and 17.2, respectively, per 1000
         patients                                     lished outcomes (and not contact-       patient-years. The rate of strokes
    1c: Absolute SpPins and SnNouts                   ing authors for additional data), the   (approximately 7 per 1000 patient-
    2a: Systematic review of level >2                 authors had incomplete data from        years) and the total death rate were
    2b: Independent blind or objective
         comparison, study confined
                                                      which to draw their conclusions.        comparable regardless of treatment
         to a narrow spectrum of study                (LOE = 1a-)                             (approximately 18 deaths per 1000
         individuals, or a diagnostic clinical                                                patient-years). The average differ-
         rule not validated in a test set
                                                      Study Design                            ence between glycohemoglobin lev-
                                                          Meta-analysis (randomized con-      els in patients treated with inten-
    1a: Systematic review of inception                trolled trials)                         sive care and with usual care was
         cohort studies                                                                       approximately 1%. In these studies,
    1b: Individual inception cohort study             Funding                                 blood pressure control and control
         with >80% foll
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