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- Holgersson, Johan, et al.
(författare)
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Hypothermic versus Normothermic Temperature Control after Cardiac Arrest
- 2022
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Ingår i: NEJM Evidence. - 2766-5526. ; 1:11, s. 1-13
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUNDThe evidence for temperature control for comatose survivors of cardiac arrest is inconclusive. Controversy exists as to whether the effects of hypothermia differ per the circumstances of the cardiac arrest or patient characteristics.METHODSAn individual patient data meta-analysis of the Targeted Temperature Management at 33°C versus 36°C after Cardiac Arrest (TTM) and Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest (TTM2) trials was conducted. The intervention was hypothermia at 33°C and the comparator was normothermia. The primary outcome was all-cause mortality at 6 months. Secondary outcomes included poor functional outcome (modified Rankin scale score of 4 to 6) at 6 months. Predefined subgroups based on the design variables in the original trials were tested for interaction with the intervention as follows: age (older or younger than the median), sex (female or male), initial cardiac rhythm (shockable or nonshockable), time to return of spontaneous circulation (above or below the median), and circulatory shock on admission (presence or absence).RESULTSThe primary analyses included 2800 patients, with 1403 assigned to hypothermia and 1397 to normothermia. Death occurred for 691 of 1398 participants (49.4%) in the hypothermia group and 666 of 1391 participants (47.9%) in the normothermia group (relative risk with hypothermia, 1.03; 95% confidence interval [CI], 0.96 to 1.11; P=0.41). A poor functional outcome occurred for 733 of 1350 participants (54.3%) in the hypothermia group and 718 of 1330 participants (54.0%) in the normothermia group (relative risk with hypothermia, 1.01; 95% CI, 0.94 to 1.08; P=0.88). Outcomes were consistent in the predefined subgroups.CONCLUSIONSHypothermia at 33°C did not decrease 6-month mortality compared with normothermia after out-of-hospital cardiac arrest. (Funded by Vetenskapsrådet; ClinicalTrials.gov numbers NCT02908308 and NCT01020916.)
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- Lohmander, L Stefan, et al.
(författare)
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Treatment for Acute Anterior Cruciate Ligament Tear in Young Active Adults
- 2023
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Ingår i: NEJM Evidence. - 2766-5526. ; 2:8, s. 1-13
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND Anterior cruciate ligament (ACL) injury of the knee is common in young active adults and often has severe and sometimes lifelong consequences. The clinical management of this injury remains debated. A prior trial of early versus delayed optional ACL repair showed no differences in outcomes at 2 years. METHODS We present the 11-year follow-up of a randomized clinical trial involving 121 young active adults (mean age 26yo, 74% male) with an acute sports-related ACL tear. We compared patient-reported and radiographic outcomes between those randomized to receive early ACL reconstruction (ACLR) followed by exercise therapy (N=62) and those treated with early exercise therapy plus optional delayed ACLR (N=59). The primary end point at 11 years was change from baseline in the mean of four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS) — pain, symptoms, function in sports and recreation, and knee-related quality of life (KOOS4; range of scores, 0 [worst]to 100 [best]; minimal important change=9). RESULTS In all, 88% of the cohort followed up at 11 years (53/62 in the early vs. 54/59 in the optional late ACL repair groups), and 52% of those assigned to optional delayed ACLR underwent ACLR. Mean improvement in KOOS4 from baseline to 11 years was 46 points for those assigned to early ACLR plus exercise therapy and 45 points for those assigned to exercise therapy plus optional delayed ACLR (between-group difference, 1.6 points; 95% confidence interval [CI], -8.8 to 5.6; P=0.67 after adjustment for baseline score, full analysis set). About two thirds of the full cohort reported meeting the case definition for a “patient-acceptable symptom state” (KOOS4 patient-acceptable symptom state threshold value=79), whereas 44% had developed radiographic osteoarthritis of their injured knee. Mean summed incident radiographic osteoarthritis feature scores, scores range from 0 to 30 where higher scores indicate more severe joint damage, were 2.4 for the group assigned to early ACLR and 1.0 for the group assigned to exercise therapyplus optional delayed ACLR (mean difference, 1.0; 95% CI, 0.1 to 1.9). CONCLUSIONS At 11-year follow-up, among young active adults with acute ACL tears assigned to early ACLR plus exercise versus initial exercise therapy with the option of delayed ACLR, there were no differences in patientreportedoutcomes. (Funded by the Swedish Research Council; ISRCTN number, ISRCTN84752559.)
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- Lundgren, Jens D, et al.
(författare)
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Long-Term Benefits from Early Antiretroviral Therapy Initiation in HIV Infection.
- 2023
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Ingår i: NEJM evidence. - : Massachusetts Medical Society. - 2766-5526. ; 2:3
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Tidskriftsartikel (refereegranskat)abstract
- For people with HIV and CD4+ counts >500 cells/mm3, early initiation of antiretroviral therapy (ART) reduces serious AIDS and serious non-AIDS (SNA) risk compared with deferral of treatment until CD4+ counts are <350 cells/mm3. Whether excess risk of AIDS and SNA persists once ART is initiated for those who defer treatment is uncertain.The Strategic Timing of AntiRetroviral Treatment (START) trial, as previously reported, randomly assigned 4684 ART-naive HIV-positive adults with CD4+ counts .500 cells/mm3 to immediate treatment initiation after random assignment (n = 2325) or deferred treatment (n= 2359). In 2015, a 57% lower risk of the primary end point (AIDS, SNA, or death) for the immediate group was reported, and the deferred group was offered ART. This article reports the follow-up that continued to December 31, 2021. Cox proportional-hazards models were used to compare hazard ratios for the primary end point from randomization through December 31, 2015, versus January 1, 2016, through December 31, 2021.Through December 31, 2015, approximately 7 months after the cutoff date from the previous report, the median CD4+ count was 648 and 460 cells/mm3 in the immediate and deferred groups, respectively, at treatment initiation. The percentage of follow-up time spent taking ART was 95% and 36% for the immediate and deferred groups, respectively, and the time-averaged CD4+ difference was 199 cells/mm3. After January 1, 2016, the percentage of follow-up time on treatment was 97.2% and 94.1% for the immediate and deferred groups, respectively, and the CD4+ count difference was 155 cells/mm3. After January 1, 2016, a total of 89 immediate and 113 deferred group participants experienced a primary end point (hazard ratio of 0.79 [95% confidence interval, 0.60 to 1.04] versus hazard ratio of 0.47 [95% confidence interval, 0.34 to 0.65; P<0.001]) before 2016 (P=0.02 for hazard ratio difference).Among adults with CD4+ counts >500 cells/mm3, excess risk of AIDS and SNA associated with delaying treatment initiation was diminished after ART initiation, but persistent excess risk remained. (Funded by the National Institute of Allergy and Infectious Diseases and others.).
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