| 1. |
- Ahmad, Shafqat, et al.
(författare)
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Mediterranean Diet Adherence and Risk of All-Cause Mortality in Women
- 2024
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Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 7:5
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Tidskriftsartikel (refereegranskat)abstract
- Importance Higher adherence to the Mediterranean diet has been associated with reduced risk of all-cause mortality, but data on underlying molecular mechanisms over long follow-up are limited. Objectives To investigate Mediterranean diet adherence and risk of all-cause mortality and to examine the relative contribution of cardiometabolic factors to this risk reduction. Design, Setting, and Participants This cohort study included initially healthy women from the Women's Health Study, who had provided blood samples, biomarker measurements, and dietary information. Baseline data included self-reported demographics and a validated food-frequency questionnaire. The data collection period was from April 1993 to January 1996, and data analysis took place from June 2018 to November 2023. Exposures Mediterranean diet score (range, 0-9) was computed based on 9 dietary components. Main Outcome and Measures Thirty-three blood biomarkers, including traditional and novel lipid, lipoprotein, apolipoprotein, inflammation, insulin resistance, and metabolism measurements, were evaluated at baseline using standard assays and nuclear magnetic resonance spectroscopy. Mortality and cause of death were determined from medical and death records. Cox proportional hazards regression was used to calculate hazard ratios (HRs) for Mediterranean diet adherence and mortality risk, and mediation analyses were used to calculate the mediated effect of different biomarkers in understanding this association. Results Among 25 315 participants, the mean (SD) baseline age was 54.6 (7.1) years, with 329 (1.3%) Asian women, 406 (1.6%) Black women, 240 (0.9%) Hispanic women, 24 036 (94.9%) White women, and 95 (0.4%) women with other race and ethnicity; the median (IQR) Mediterranean diet adherence score was 4.0 (3.0-5.0). Over a mean (SD) of 24.7 (4.8) years of follow-up, 3879 deaths occurred. Compared with low Mediterranean diet adherence (score 0-3), adjusted risk reductions were observed for middle (score 4-5) and upper (score 6-9) groups, with HRs of 0.84 (95% CI, 0.78-0.90) and 0.77 (95% CI, 0.70-0.84), respectively (P for trend < .001). Further adjusting for lifestyle factors attenuated the risk reductions, but they remained statistically significant (middle adherence group: HR, 0.92 [95% CI, 0.85-0.99]; upper adherence group: HR, 0.89 [95% CI, 0.82-0.98]; P for trend = .001). Of the biomarkers examined, small molecule metabolites and inflammatory biomarkers contributed most to the lower mortality risk (explaining 14.8% and 13.0%, respectively, of the association), followed by triglyceride-rich lipoproteins (10.2%), body mass index (10.2%), and insulin resistance (7.4%). Other pathways, including branched-chain amino acids, high-density lipoproteins, low-density lipoproteins, glycemic measures, and hypertension, had smaller contributions (<3%). Conclusions and Relevance In this cohort study, higher adherence to the Mediterranean diet was associated with 23% lower risk of all-cause mortality. This inverse association was partially explained by multiple cardiometabolic factors.
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| 2. |
- Andrén, Per, et al.
(författare)
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Internet-Delivered Exposure and Response Prevention for Pediatric Tourette Syndrome : 12-Month Follow-Up of a Randomized Clinical Trial
- 2024
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Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 7:5
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE: Behavior therapy is a recommended intervention for Tourette syndrome (TS) and chronic tic disorder (CTD), but availability is limited and long-term effects are uncertain.OBJECTIVE: To investigate the long-term efficacy and cost-effectiveness of therapist-supported, internet-delivered exposure and response prevention (ERP) vs psychoeducation for youths with TS or CTD.DESIGN, SETTING, AND PARTICIPANTS: This 12-month controlled follow-up of a parallel group, superiority randomized clinical trial was conducted at a research clinic in Stockholm, Sweden, with nationwide recruitment. In total, 221 participants aged 9 to 17 years with TS or CTD were enrolled between April 26, 2019, and April 9, 2021, of whom 208 (94%) provided 12-month follow-up data. Final follow-up data were collected on June 29, 2022. Outcome assessors were masked to treatment allocation throughout the study.INTERVENTIONS: A total of 111 participants were originally randomly allocated to 10 weeks of therapist-supported, internet-delivered ERP and 110 participants to therapist-supported, internet-delivered psychoeducation.MAIN OUTCOMES AND MEASURES: The primary outcome was within-group change in tic severity, measured by the Total Tic Severity Score of the Yale Global Tic Severity Scale (YGTSS-TTSS), from the 3-month follow-up to the 12-month follow-up. Treatment response was defined as 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement scale. Analyses were intention-to-treat and followed the plan prespecified in the published study protocol. A health economic evaluation was performed from 3 perspectives: health care organization (including direct costs for treatment provided in the study), health care sector (additionally including health care resource use outside of the study), and societal (additionally including costs beyond health care [eg, parent's absenteeism from work]).RESULTS: In total, 221 participants were recruited (mean [SD] age, 12.1 [2.3] years; 152 [69%] male). According to the YGTSS-TTSS, there were no statistically significant changes in tic severity from the 3-month to the 12-month follow-up in either group (ERP coefficient, -0.52 [95% CI, -1.26 to 0.21]; P = .16; psychoeducation coefficient, 0.00 [95% CI, -0.78 to 0.78]; P > .99). A secondary analysis including all assessment points (baseline to 12-month follow-up) showed no statistically significant between-group difference in tic severity from baseline to the 12-month follow-up (coefficient, -0.38 [95% CI, -1.11 to 0.35]; P = .30). Treatment response rates were similar in both groups (55% in ERP and 50% in psychoeducation; odds ratio, 1.25 [95% CI, 0.73-2.16]; P = .42) at the 12-month follow-up. The health economic evaluation showed that, from a health care sector perspective, ERP produced more quality-adjusted life years (0.01 [95% CI, -0.01 to 0.03]) and lower costs (adjusted mean difference -$84.48 [95% CI, -$440.20 to $977.60]) than psychoeducation at the 12-month follow-up. From the health care organization and societal perspectives, ERP produced more quality-adjusted life years at higher costs, with 65% to 78% probability of ERP being cost-effective compared with psychoeducation when using a willingness-to-pay threshold of US $79 000.CONCLUSIONS AND RELEVANCE: There were no statistically significant changes in tic severity from the 3-month through to the 12-month follow-up in either group. The ERP intervention was not superior to psychoeducation at any time point. While ERP was not superior to psychoeducation alone in reducing tic severity at the end of the follow-up period, ERP is recommended for clinical implementation due to its likely cost-effectiveness and support from previous literature.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03916055.
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| 5. |
- Blom, Johannes, et al.
(författare)
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Routine fecal occult blood screening and colorectal cancer mortality in Sweden
- 2024
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Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 7:2
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Tidskriftsartikel (refereegranskat)abstract
- Importance: Population-based colorectal cancer (CRC) screening programs are implemented worldwide, but there are difficulties evaluating their effectiveness. The magnitude of routine CRC screening effectiveness regarding cancer-specific mortality is unclear.Objective: To evaluate cancer-specific mortality associated with early vs late or no invitation for routine CRC screening using fecal occult blood testing.Design, Setting, and Participants: This prospective cohort study was performed in the region of Stockholm-Gotland, Sweden, between January 1, 2008, and December 31, 2021. All individuals of the target population of screening born from 1938 to 1954 were included. Data were analyzed from December 12, 2022, to June 25, 2023.Exposures: Individuals were invited early (2008-2012), late (2013-2015), or not at all to screening with biennial guaiac-based fecal occult blood test. The early invitation group was considered the exposure group and the late or no invitation group was considered the control group.Main Outcomes and Measures: The main outcome was cancer-specific mortality, defined as CRC registered in the Cancer Register with CRC as underlying cause of death in the Cause of Death Register. Excess mortality was calculated as all-cause deaths among the individuals with CRC subtracted from the expected number of deaths had they not had CRC. Poisson regression analysis based on deaths and person-years was used to estimated mortality rate ratio (RR) with 95% CIs, adjusted for follow-up years and attained age.Results: In total, 379 448 individuals (193 436 [51.0%] female) were invited for CRC screening, including 203 670 individuals in the exposure group and 175 778 in the control group. The mean screening participation rate was 63.3%, and there was a maximum of 14 years follow-up. There were 834 CRC deaths in 2 190 589 person-years in the exposure group, compared with 889 CRC deaths in 2 249 939 person-years in the control group. Individuals who underwent early CRC screening had reduced adjusted risk of CRC mortality (RR, 0.86; 95% CI, 0.78-0.95) and excess mortality (RR, 0.84; 95% CI, 0.75-0.93).Conclusions and Relevance: This prospective cohort study of routine screening with fecal occult blood testing found a 14% decrease in CRC mortality associated with screening. The true association of screening with reduced mortality is expected to be higher due to some coexistence of testing in the control group and CRC deaths diagnosed more than 2 years after screening.
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| 7. |
- Charalampidis, Anastasios, et al.
(författare)
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Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis
- 2024
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Ingår i: JAMA Network Open. - : AMER MEDICAL ASSOC. - 2574-3805. ; 7:1
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE Moderate-grade adolescent idiopathic scoliosis (AIS) may be treated with full-timebracing. For patients who reject full-time bracing, the effects of alternative, conservativeinterventions are unknown.OBJECTIVE To determine whether self-mediated physical activity combined with either nighttimebracing (NB) or scoliosis-specific exercise (SSE) is superior to a control of physical activity alone (PA)in preventing Cobb angle progression in moderate-grade AIS.DESIGN, SETTING, AND PARTICIPANTS The Conservative Treatment for Adolescent IdiopathicScoliosis (CONTRAIS) randomized clinical trial was conducted from January 10, 2013, throughOctober 23, 2018, in 6 public hospitals across Sweden. Male and female children and adolescentsaged 9 to 17 years with an AIS primary curve Cobb angle of 25° to 40°, apex T7 or caudal, and skeletalimmaturity based on estimated remaining growth of at least 1 year were included in the study. Datesof analysis were from October 25, 2021, to January 28, 2023.INTERVENTIONS Interventions included self-mediated physical activity in combination with eitherNB or SSE or PA (control). Patients with treatment failure were given the option to transition to afull-time brace until skeletal maturity.MAIN OUTCOMES AND MEASURES The primary outcome was curve progression of 6° or less(treatment success) or curve progression of more than 6° (treatment failure) seen on 2 consecutiveposteroanterior standing radiographs compared with the inclusion radiograph before skeletalmaturity. A secondary outcome of curve progression was the number of patients undergoing surgeryup until 2 years after the primary outcome.RESULTS The CONTRAIS study included 135 patients (45 in each of the 3 groups) with a mean (SD)age of 12.7 (1.4) years; 111 (82%) were female. Treatment success was seen in 34 of 45 patients (76%)in the NB group and in 24 of 45 patients (53%) in the PA group (odds ratio [OR], 2.7; 95% CI, 1.1-6.6).The number needed to treat to prevent curve progression with NB was 4.5 (95% CI, 2.4-33.5).Treatment success occurred in 26 of 45 patients (58%) in the SSE group (OR for SE vs PA, 1.2; 95% CI,0.5-2.8). Up to 2 years after the primary outcome time point, 9 patients in each of the 3 groupsunderwent surgery.CONCLUSIONS AND RELEVANCE In this randomized clinical trial, treatment with NB preventedcurve progression of more than 6° to a significantly higher extent than did PA, while SSE did not; inaddition, allowing transition to full-time bracing after treatment failure resulted in similar surgicalfrequencies independent of initial treatment. These results suggest that NB may be an effectivealternative intervention in patients rejecting full-time bracing.
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| 8. |
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| 9. |
- Clausen, Henning, et al.
(författare)
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Newborn Screening for High-Risk Congenital Heart Disease by Dried Blood Spot Biomarker Analysis.
- 2024
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Ingår i: JAMA Network Open. - 2574-3805. ; 7:6
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Tidskriftsartikel (refereegranskat)abstract
- Importance Congenital heart disease (CHD) is the most common human organ malformation, affecting approximately 1 of 125 newborns globally.Objectives Assessing the performance of 2 diagnostic tests using minimal amounts of dried blood spots (DBS) to identify high-risk CHD compared with controls in a Swedish cohort of neonates.Design, Setting, and Participants This diagnostic study took place in Sweden between 2019 and 2023 and enrolled full-term babies born between 2005 and 2023. All cases were identified through centralized pediatric cardiothoracic surgical services in Lund and Gothenburg, Sweden. Controls were followed up for 1 year to ensure no late presentations of high-risk CHD occurred. Cases were verified through surgical records and echocardiography.Exposure High-risk CHD, defined as cases requiring cardiac surgical management during infancy due to evolving signs of heart failure or types in which the postnatal circulation depends on patency of the arterial duct. Using 3-μL DBS samples, automated quantitative tests for NT-proBNP and interleukin 1 receptor-like 1 (IL-1 RL1; formerly known as soluble ST2) were compared against established CHD screening methods.Main Outcomes and Measures Performance of DBS tests to detect high-risk CHD using receiver operating characteristic curves; Bland-Altman and Pearson correlation analyses to compare IL-1 RL1 DBS with plasma blood levels.Results A total of 313 newborns were included (mean [SD] gestational age, 39.4 [1.3] weeks; 181 [57.8%] male). Mean (SD) birthweight was 3495 (483) grams. Analyzed DBS samples included 217 CHD cases and 96 controls. Among the CHD cases, 188 participants (89.3%) were high-risk types, of which 73 (38.8%) were suspected prenatally. Of the 188 high-risk cases, 94 (50.0%) passed pulse oximetry screening and 36 (19.1%) were initially discharged after birth without diagnoses. Combining NT-proBNP and IL-1 RL1 tests performed well in comparison with existing screening methods and enabled additional identification of asymptomatic babies with receiver operating characteristic area under the curve 0.95 (95% CI, 0.93-0.98).Conclusions and relevance In this diagnostic study, NT-proBNP and IL-1 RL1 DBS assays identified high-risk CHD in a timely manner, including in asymptomatic newborns, and improved overall screening performance in this cohort from Sweden. Prospective evaluation of this novel approach is warranted.
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| 13. |
- Garcia-Argibay, Miguel, 1988-, et al.
(författare)
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Methylphenidate and Short-Term Cardiovascular Risk
- 2024
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Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 7:3
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Tidskriftsartikel (refereegranskat)abstract
- Importance: There are concerns about the safety of medications for treatment of attention-deficit/hyperactivity disorder (ADHD), with mixed evidence on possible cardiovascular risk.Objective: To assess whether short-term methylphenidate use is associated with risk of cardiovascular events.Design, Setting, and Participants: This retrospective, population-based cohort study was based on national Swedish registry data. Participants were individuals with ADHD aged 12 to 60 years with dispensed prescriptions of methylphenidate between January 1, 2007, and June 30, 2012. Each person receiving methylphenidate (n = 26 710) was matched on birth date, sex, and county to up to 10 nonusers without ADHD (n = 225 672). Statistical analyses were performed from September 13, 2022, to May 16, 2023.Main Outcomes and Measures: Rates of cardiovascular events, including ischemic heart disease, venous thromboembolism, heart failure, or tachyarrhythmias, 1 year before methylphenidate treatment and 6 months after treatment initiation were compared between individuals receiving methylphenidate and matched controls using a bayesian within-individual design. Analyses were stratified by history of cardiovascular events.Results: The cohort included 252 382 individuals (15 442 [57.8% men]; median age, 20 (IQR, 15-31) years). The overall incidence of cardiovascular events was 1.51 per 10 000 person-weeks (95% highest density interval [HDI], 1.35-1.69) for individuals receiving methylphenidate and 0.77 (95% HDI, 0.73-0.82) for the matched controls. Individuals treated with methylphenidate had an 87% posterior probability of having a higher rate of cardiovascular events after treatment initiation (incidence rate ratio [IRR], 1.41; 95% HDI, 1.09-1.88) compared with matched controls (IRR, 1.18; 95% HDI, 1.02-1.37). The posterior probabilities were 70% for at least a 10% increased risk of cardiovascular events in individuals receiving methylphenidate vs 49% in matched controls. No difference was found in this risk between individuals with and without a history of cardiovascular disease (IRR, 1.11; 95% HDI, 0.58-2.13).Conclusions and Relevance: In this cohort study, individuals receiving methylphenidate had a small increased cardiovascular risk vs matched controls in the 6 months after treatment initiation. However, there was little evidence for an increased risk of 20% or higher and for differences in risk increase between people with and without a history of cardiovascular disease. Therefore, before treatment initiation, careful consideration of the risk-benefit trade-off of methylphenidate would be useful, regardless of cardiovascular history.
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| 14. |
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| 15. |
- Gillving, Cecilia, 1999-, et al.
(författare)
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Seizure Duration and Electroconvulsive Therapy in Major Depressive Disorder
- 2024
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Ingår i: JAMA Network Open. - : AMER MEDICAL ASSOC. - 2574-3805. ; 7:7
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE Electroconvulsive therapy (ECT), wherein a generalized epileptic seizure is induced, is a treatment for major depressive disorder (MDD). Currently, it is unclear whether there is an association between seizure length and treatment outcome. OBJECTIVE To explore the association between seizure duration, potential confounding variables, and ECT treatment outcome. DESIGN, SETTING, AND PARTICIPANTS This population-based cohort study obtained data from the Swedish National Quality Register for ECT. Patients treated for unipolar MDD with unilateral electrode placement between January 1, 2012, and December 31, 2019, were included. The electroencephalographic (EEG) seizure duration from the first ECT treatment session for each patient was used for analysis. Data analyses were performed between March 2021 and May 2024. MAIN OUTCOMES AND MEASURESThe primary outcome was remission, defined as a cutoff score of less than 10 points on the self-assessment version of the Montgomery-& Aring;sberg Depression Rating Scale within 1 week after ECT. Multivariate logistic regression analysis was performed to calculate odds ratios (ORs) between different seizure duration groups. Furthermore, the associations between concomitant use of pharmacological treatments, seizure duration, and remission rate were explored. RESULTS Among the 6998 patients included, 4229 (60.4%) were female and the mean (SD) age was 55.2 (18.6) years. Overall, 2749 patients (39.3%) achieved remission after ECT. Patients with EEG seizure duration of 60 to 69 seconds had the highest remission rates compared with patients with seizure duration of less than 20 seconds (OR, 2.17; 95% CI, 1.63-2.88; P < .001). Anticonvulsant medications were associated with shorter seizure duration (eg, lamotrigine: beta coefficient [SE], -6.02 [1.08]; P < .001) and lower remission rates (eg, lamotrigine: adjusted OR, 0.67; 95% CI, 0.53-0.84; P < .001). CONCLUSIONS AND RELEVANCE This study found an association between seizure length and remission from MDD. Use of anticonvulsant medication during ECT was associated with shorter seizure duration and lower remission rates after ECT.
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| 16. |
- Gregori, Giulia, et al.
(författare)
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Limosilactobacillus reuteri 6475 and Prevention of Early Postmenopausal Bone Loss: A Randomized Clinical Trial
- 2024
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Ingår i: JAMA Network Open. - : AMER MEDICAL ASSOC. - 2574-3805. ; 7:6
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Tidskriftsartikel (refereegranskat)abstract
- Importance Daily supplementation with the probiotic Limosilactobacillus reuteri ATCC PTA 6475 (L reuteri) vs placebo has previously been demonstrated to reduce bone loss in an estrogen deficiency mice model and older women, although the magnitude of the effect was small. We hypothesized that long-term treatment with L reuteri could result in clinically relevant skeletal benefits in postmenopausal osteoporosis. Objective To evaluate whether daily supplementation with L reuteri vs placebo could reduce early postmenopausal bone loss and whether the effects remained or increased over time during 2 years of treatment. Design, Setting, and Participants A double-blind, randomized, placebo-controlled clinical trial was conducted between December 4, 2019, and October 6, 2022, at a single center in Gothenburg, southwestern Sweden. Participants were recruited by online advertisements, and letters were sent to 10 062 women aged 50 to 60 years. Responding women (n = 752) underwent telephone screening, resulting in 292 women being invited to a screening visit. Of those who were screened, 239 women met all inclusion criteria and had no exclusion criteria. Interventions Capsules with L reuteri in 2 doses, 5 x 108 (low dose) or 5 x 109 (high dose) colony-forming units, taken twice daily or placebo were administered. All capsules also included cholecalciferol, 200 IU. Main Outcomes and MeasuresThe primary outcome was the relative change in tibia total volumetric bone mineral density (vBMD) over 2 years. Secondary outcomes included relative change in areal BMD of the lumbar spine and total hip, bone turnover markers C-terminal telopeptide cross-links of collagen type I and type I procollagen intact N-terminal propeptide, as well as tibia trabecular bone volume fraction and cortical vBMD. Both intention-to-treat and per-protocol analyses were conducted. Results A total of 239 postmenopausal women (median age, 55 [IQR, 53-56] years) were included. Tibia vBMD (primary outcome), hip and spine vBMD, and tibia cortical area and BMD decreased significantly in all groups, with no group-to-group differences (percent change tibia vBMD high dose vs placebo least-squares means, -0.08 [95 CI, -0.85 to 0.69] and low dose vs placebo least-squares means, -0.22 [95% CI, -0.99 to 0.55]). There were no significant treatment effects on any other predefined outcomes. A prespecified sensitivity analysis found a significant interaction between body mass index (BMI) and treatment effect at 2 years. No significant adverse effects were observed. Conclusions and Relevance In this randomized clinical trial of 239 early postmenopausal women, supplementation with L reuteri had no effect on bone loss or bone turnover over 2 years. The observed interaction between BMI and treatment effect warrants further investigation. Trial RegistrationClinicalTrials.gov Identifier: NCT04169789
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| 17. |
- Gyllensvaerd, Johan, et al.
(författare)
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Antibiotic Use in Late Preterm and Full-Term Newborns
- 2024
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Ingår i: JAMA Network Open. - : AMER MEDICAL ASSOC. - 2574-3805. ; 7:3
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Tidskriftsartikel (refereegranskat)abstract
- Importance Antibiotic treatment saves lives in newborns with early-onset sepsis (EOS), but unwarranted antibiotic use is associated with resistant bacteria and adverse outcomes later in life. Surveillance is needed to optimize treatment strategies. Objective To describe antibiotic use in association with the incidence and mortality from EOS among late-preterm and full-term newborns. Design, Setting, and Participants The Sweden Neonatal Antibiotic Use study was a nationwide observational study that included all late-preterm and full-term neonates born from January 1, 2012, to December 31, 2020, in neonatal units of all levels. All hospital live births from 34 weeks' gestation during the study period were included in the study. Data were collected from the Swedish Neonatal Quality Register and the Swedish Medical Birth Register. Data were analyzed from August 2022 to May 2023. Exposure Admission for neonatal intensive care during the first week of life. Main Outcomes and Measures The main outcomes were the usage of intravenous antibiotics during the first week of life, the duration of antibiotic therapy, the rate of culture-proven EOS, and mortality associated with EOS. Results A total of 1 025 515 newborns were included in the study; 19 286 neonates (1.88%; 7686 girls [39.9%]; median [IQR] gestational age, 40 [38-41] weeks; median [IQR] birth weight, 3610 [3140-4030] g) received antibiotics during the first week of life, of whom 647 (3.4%) had EOS. The median (IQR) duration of antibiotic treatment in newborns without EOS was 5 (3-7) days, and there were 113 antibiotic-days per 1000 live births. During the study period there was no significant change in the exposure to neonatal antibiotics or antibiotic-days per 1000 live births. The incidence of EOS was 0.63 per 1000 live births, with a significant decrease from 0.74 in 2012 to 0.34 in 2020. Mortality associated with EOS was 1.39% (9 of 647 newborns) and did not change significantly over time. For each newborn with EOS, antibiotic treatment was initiated in 29 newborns and 173 antibiotic-days were dispensed. Conclusions and Relevance This large nationwide study found that a relatively low exposure to antibiotics is not associated with an increased risk of EOS or associated mortality. Still, future efforts to reduce unwarranted neonatal antibiotic use are needed.
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| 19. |
- Hedberg, Suzanne, et al.
(författare)
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Comparison of Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass : A Randomized Clinical Trial
- 2024
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Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 7:1
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE: Laparoscopic sleeve gastrectomy (SG) and laparoscopic Roux-en-Y gastric bypass (RYGB) are widely used bariatric procedures for which comparative efficacy and safety remain unclear.OBJECTIVE: To compare perioperative outcomes in SG and RYGB.DESIGN, SETTING, AND PARTICIPANTS: In this registry-based, multicenter randomized clinical trial (Bypass Equipoise Sleeve Trial), baseline and perioperative data for patients undergoing bariatric surgery from October 6, 2015, to March 31, 2022, were analyzed. Patients were from university, regional, county, and private hospitals in Sweden (n = 20) and Norway (n = 3). Adults (aged ≥18 years) eligible for bariatric surgery with body mass indexes (BMIs; calculated as weight in kilograms divided by height in meters squared) of 35 to 50 were studied.INTERVENTIONS: Laparoscopic SG or RYGB.MAIN OUTCOMES AND MEASURES: Perioperative complications were analyzed as all adverse events and serious adverse events (Clavien-Dindo grade >IIIb). Ninety-day mortality was also assessed.RESULTS: A total of 1735 of 14 182 eligible patients (12%; 1282 [73.9%] female; mean (SD) age, 42.9 [11.1] years; mean [SD] BMI, 40.8 [3.7]) were included in the study. Patients were randomized and underwent SG (n = 878) or RYGB (n = 857). The mean (SD) operating time was shorter in those undergoing SG vs RYGB (47 [18] vs 68 [25] minutes; P < .001). The median (IQR) postoperative hospital stay was 1 (1-1) day in both groups. The 30-day readmission rate was 3.1% after SG and 4.0% after RYGB (P = .33). There was no 90-day mortality. The 30-day incidence of any adverse event was 40 (4.6%) and 54 (6.3%) in the SG and RYGB groups, respectively (odds ratio, 0.71; 95% CI, 0.47-1.08; P = .11). Corresponding figures for serious adverse events were 15 (1.7%) for the SG group and 23 (2.7%) for the RYGB group (odds ratio, 0.63; 95% CI, 0.33-1.22; P = .19).CONCLUSIONS AND RELEVANCE: This randomized clinical trial of 1735 patients undergoing primary bariatric surgery found that both SG and RYGB were performed with a low perioperative risk without clinically significant differences between groups.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02767505.
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| 20. |
- Herrmann, Florian E M, 1990, et al.
(författare)
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Recurrence of Atrial Fibrillation in Patients With New-Onset Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting.
- 2024
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Ingår i: JAMA network open. - 2574-3805. ; 7:3
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Tidskriftsartikel (refereegranskat)abstract
- New-onset postoperative atrial fibrillation (POAF) occurs in approximately 30% of patients undergoing coronary artery bypass grafting (CABG). It is unknown whether early recurrence is associated with worse outcomes.To test the hypothesis that early AF recurrence in patients with POAF after CABG is associated with worse outcomes.This Swedish nationwide cohort study used prospectively collected data from the SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry and 3 other mandatory national registries. The study included patients who underwent isolated first-time CABG between January 1, 2007, and December 31, 2020, and developed POAF. Data analysis was performed between March 6 and September 16, 2023.Early AF recurrence defined as an episode of AF leading to hospital care within 3 months after discharge.The primary outcome was all-cause mortality. Secondary outcomes included ischemic stroke, any thromboembolism, heart failure hospitalization, and major bleeding within 2 years after discharge. The groups were compared with multivariable Cox regression models, with early AF recurrence as a time-dependent covariate. The hypothesis tested was formulated after data collection.Of the 35329 patients identified, 10609 (30.0%) developed POAF after CABG and were included in this study. Their median age was 71 (IQR, 66-76) years. The median follow-up was 7.1 (IQR, 2.9-9.0) years, and most patients (81.6%) were men. Early AF recurrence occurred in 6.7% of patients. Event rates (95% CIs) per 100 patient-years with vs without early AF recurrence were 2.21 (1.49-3.24) vs 2.03 (1.83-2.25) for all-cause mortality, 3.94 (2.92-5.28) vs 2.79 (2.56-3.05) for heart failure hospitalization, and 3.97 (2.95-5.30) vs 2.74 (2.51-2.99) for major bleeding. No association between early AF recurrence and all-cause mortality was observed (adjusted hazard ratio [AHR], 1.17 [95% CI, 0.80-1.74]; P=.41). In exploratory analyses, there was an association with heart failure hospitalization (AHR, 1.80 [95% CI, 1.32-2.45]; P=.001) and major bleeding (AHR, 1.92 [1.42-2.61]; P<.001).In this cohort study of early AF recurrence after POAF in patients who underwent CABG, no association was found between early AF recurrence and all-cause mortality. Exploratory analyses showed associations between AF recurrence and heart failure hospitalization, oral anticoagulation, and major bleeding.
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| 21. |
- Holm, Jonas, et al.
(författare)
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Association of Glutamate Infusion With Risk of Acute Kidney Injury After Coronary Artery Bypass Surgery A Pooled Analysis of 2 Randomized Clinical Trials
- 2024
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Ingår i: JAMA Network Open. - : AMER MEDICAL ASSOC. - 2574-3805. ; 7:1
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Tidskriftsartikel (refereegranskat)abstract
- Importance Acute kidney injury (AKI) after cardiac surgery is associated with increased morbidity and mortality, and measures to prevent AKI have had limited success. Glutamate has been reported to enhance natural postischemic recovery of the heart, but not among animals and humans with diabetes. Objective To summarize pooled results from the GLUTAMICS (Glutamate for Metabolic Intervention in Coronary Surgery) trials regarding the effect of glutamate on postoperative AKI among patients without diabetes undergoing coronary artery bypass graft (CABG) surgery. Design, Setting, and Participants Data on a total of 791 patients without diabetes from 2 prospective, randomized, double-blind multicenter trials performed at 5 cardiac surgery centers in Sweden between October 4, 2005, and November 12, 2009, and between November 15, 2015, and September 30, 2020, were pooled. Patients had acute coronary syndrome, left ventricular ejection fraction of 0.30 or less, or a European System for Cardiac Risk Evaluation II score of 3.0 or more and underwent CABG with or without additional valve procedure. Statistical analysis was performed from May to November 2023. Interventions Intravenous infusion of 0.125-M l-glutamic acid or saline at 1.65 mL/kg/h for 2 hours during reperfusion, after which the infusion rate was halved and an additional 50 mL was given. Main Outcomes and Measures The primary end point was AKI, defined as postoperative increase of plasma creatinine of 50% or more, corresponding to the Risk stage or higher in the Risk, Injury, Failure, Loss, and End-Stage kidney disease (RIFLE) criteria. Results A total of 791 patients without diabetes (391 who received glutamate [mean (SD) age, 69.3 (9.1) years; 62 women (15.9%)] and 400 controls [mean (SD) age, 69.6 (9.5) years; 73 women (18.3%)]) were randomized. Baseline data did not differ between groups. Glutamate was associated with a significantly lower risk of AKI (relative risk, 0.49 [95% CI, 0.29-0.83]). Dialysis was required for 2 patients in the glutamate group and 5 patients in the control group. In multivariable analysis, glutamate remained significantly associated with a protective effect against AKI (odds ratio, 0.47 [95% CI, 0.26-0.86]). In the glutamate and control groups, the rate of postoperative mortality at 30 days or less was 0.5% (2 of 391) vs 1.0% (4 of 400), and the rate of stroke at 24 hours or less was 0.8% (3 of 391) vs 1.8% (7 of 400). Conclusions and Relevance In this pooled analysis of 2 randomized clinical trials, infusion of glutamate was associated with a markedly lower risk of AKI after CABG among patients without diabetes. The findings are exploratory and need to be confirmed in prospective trials.
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- Karlsson, Omar, et al.
(författare)
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Prevalence of Children Aged 6 to 23 Months Who Did Not Consume Animal Milk, Formula, or Solid or Semisolid Food During the Last 24 Hours Across Low- and Middle-Income Countries
- 2024
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Ingår i: JAMA Network Open. - 2574-3805. ; 7:2
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE: The introduction of solid or semisolid foods alongside breast milk plays a vital role in meeting nutritional requirements during early childhood, which is crucial for child growth and development. Understanding the prevalence of zero-food children (defined for research purposes as children aged 6 to 23 months who did not consume animal milk, formula, or solid or semisolid food during the last 24 hours) is essential for targeted interventions to improve feeding practices.OBJECTIVE: To estimate the percentage of zero-food children in 92 low- and middle-income countries.DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed nationally representative cross-sectional household data of children aged 6 to 23 months from the Demographic and Health Surveys and the Multiple Indicator Cluster Surveys conducted between May 20, 2010, and January 27, 2022. Data were obtained from 92 low- and middle-income countries. Standardized procedures were followed to ensure data comparability and reliability. Both percentage and number of zero-food children were estimated.MAIN OUTCOMES AND MEASURES: The outcome studied was defined as a binary variable indicating children aged 6 to 23 months who had not been fed any animal milk, formula, or solid or semisolid foods during the 24 hours before each survey, as reported by the mother or caretaker.RESULTS: A sample of 276 379 children aged 6 to 23 months (mean age, 14.2 months [95% CI, 14.15-14.26 months]) in 92 low- and middle-income countries was obtained, of whom 51.4% (95% CI, 51.1%-51.8%) were boys. The estimated percentage of zero-food children was 10.4% (95% CI, 10.1%-10.7%) in the pooled sample, ranging from 0.1% (95% CI, 0%-0.6%) in Costa Rica to 21.8% (95% CI, 19.3%-24.4%) in Guinea. The prevalence of zero-food children was particularly high in West and Central Africa, where the overall prevalence was 10.5% (95% CI, 10.1%-11.0%), and in India, where the prevalence was 19.3% (95% CI, 18.9%-19.8%). India accounted for almost half of zero-food children in this study.CONCLUSIONS AND RELEVANCE: In this cross-sectional study of 276 379 children aged 6 to 23 months, substantial disparities in the estimates of food consumption across 92 low- and middle-income countries were found. The prevalence of zero-food children underscores the need for targeted interventions to improve infant and young child feeding practices and ensure optimal nutrition during this critical period of development. The issue is particularly urgent in West and Central Africa and India.
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- Leta, Tesfaye H., et al.
(författare)
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Periprosthetic Joint Infection After Total Knee Arthroplasty With or Without Antibiotic Bone Cement
- 2024
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Ingår i: JAMA Network Open. - 2574-3805. ; 7:5
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Tidskriftsartikel (refereegranskat)abstract
- Importanc eDespite increased use of antibiotic-loaded bone cement (ALBC) in joint arthroplasty over recent decades, current evidence for prophylactic use of ALBC to reduce risk of periprosthetic joint infection (PJI) is insufficient. Objective To compare the rate of revision attributed to PJI following primary total knee arthroplasty (TKA) using ALBC vs plain bone cement. Design, Setting, and Participants This international cohort study used data from 14 national or regional joint arthroplasty registries in Australia, Denmark, Finland, Germany, Italy, New Zealand, Norway, Romania, Sweden, Switzerland, the Netherlands, the UK, and the US. The study included primary TKAs for osteoarthritis registered from January 1, 2010, to December 31, 2020, and followed-up until December 31, 2021. Data analysis was performed from April to September 2023. Exposure Primary TKA with ALBC vs plain bone cement. Main Outcomes and Measures The primary outcome was risk of 1-year revision for PJI. Using a distributed data network analysis method, data were harmonized, and a cumulative revision rate was calculated (1 - Kaplan-Meier), and Cox regression analyses were performed within the 10 registries using both cement types. A meta-analysis was then performed to combine all aggregated data and evaluate the risk of 1-year revision for PJI and all causes. Results Among 2 168 924 TKAs included, 93% were performed with ALBC. Most TKAs were performed in female patients (59.5%) and patients aged 65 to 74 years (39.9%), fully cemented (92.2%), and in the 2015 to 2020 period (62.5%). All participating registries reported a cumulative 1-year revision rate for PJI of less than 1% following primary TKA with ALBC (range, 0.21%-0.80%) and with plain bone cement (range, 0.23%-0.70%). The meta-analyses based on adjusted Cox regression for 1 917 190 TKAs showed no statistically significant difference at 1 year in risk of revision for PJI (hazard rate ratio, 1.16; 95% CI, 0.89-1.52) or for all causes (hazard rate ratio, 1.12; 95% CI, 0.89-1.40) among TKAs performed with ALBC vs plain bone cement. Conclusions and Relevance In this study, the risk of revision for PJI was similar between ALBC and plain bone cement following primary TKA. Any additional costs of ALBC and its relative value in reducing revision risk should be considered in the context of the overall health care delivery system.
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