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1.
  • Ahmad, Shafqat, et al. (författare)
  • Assessment of Risk Factors and Biomarkers Associated With Risk of Cardiovascular Disease Among Women Consuming a Mediterranean Diet
  • 2018
  • Ingår i: JAMA Network Open. - : AMER MEDICAL ASSOC. - 2574-3805. ; 1:8
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE Higher Mediterranean diet (MED) intake has been associated with lower risk of cardiovascular disease (CVD), but limited data are available about the underlying molecular mechanisms of this inverse disease association in human populations.OBJECTIVE To better characterize the relative contribution of traditional and novel factors to the MED-related risk reduction in CVD events in a US population.DESIGN, SETTING, AND PARTICIPANTS Using a prospective cohort design, baseline MED intake was assessed in 25 994 initially healthy US women in theWomen's Health Study who were followed up to 12 years. Potential mediating effects of a panel of 40 biomarkers were evaluated, including lipids, lipoproteins, apolipoproteins, inflammation, glucose metabolism and insulin resistance, branched-chain amino acids, small-molecule metabolites, and clinical factors. Baseline study information and samples were collected between April 30, 1993, and January 24, 1996. Analyses were conducted between August 1, 2017, and October 30, 2018.EXPOSURES Intake of MED is a 9-category measure of adherence to a Mediterranean dietary pattern. Participants were categorized into 3 levels based on their adherence to the MED.MAIN OUTCOMES AND MEASURES Incident CVD confirmed through medical records and the proportion of CVD risk reduction explained by mediators.RESULTS Among 25 994women (mean [SD] age, 54.7 [7.1] years), those with low, middle, and upper MED intakes composed 39.0%, 36.2%, and 24.8% of the study population and experienced 428 (4.2%), 356 (3.8%), and 246 (3.8%) incident CVD events, respectively. Compared with the reference group who had low MED intake, CVD risk reductions were observed for the middle and upper groups, with respective HRs of 0.77 (95% CI, 0.67-0.90) and 0.72 (95% CI, 0.61-0.86) (P for trend < .001). The largest mediators of the CVD risk reduction of MED intake were biomarkers of inflammation (accounting for 29.2% of the MED-CVD association), glucose metabolism and insulin resistance (27.9%), and body mass index (27.3%), followed by blood pressure (26.6%), traditional lipids (26.0%), high-density lipoprotein measures (24.0%) or very low-density lipoprotein measures (20.8%), with lesser contributions from low-density lipoproteins (13.0%), branched-chain amino acids (13.6%), apolipoproteins (6.5%), or other small-molecule metabolites (5.8%).CONCLUSIONS AND RELEVANCE In this study, higher MED intake was associated with approximately one-fourth relative risk reduction in CVD events, which could be explained in part by known risk factors, both traditional and novel.
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2.
  • Ahmad, Shafqat, et al. (författare)
  • Association of the Mediterranean Diet With Onset of Diabetes in the Women’s Health Study
  • 2020
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 3:11
  • Tidskriftsartikel (refereegranskat)abstract
    • Importance  Higher Mediterranean diet (MED) intake has been associated with reduced risk of type 2 diabetes, but underlying biological mechanisms are unclear.Objective  To characterize the relative contribution of conventional and novel biomarkers in MED-associated type 2 diabetes risk reduction in a US population.Design, Setting, and Participants  This cohort study was conducted among 25 317 apparently healthy women. The participants with missing information regarding all traditional and novel metabolic biomarkers or those with baseline diabetes were excluded. Participants were invited for baseline assessment between September 1992 and May 1995. Data were collected from November 1992 to December 2017 and analyzed from December 2018 to December 2019.Exposures  MED intake score (range, 0 to 9) was computed from self-reported dietary intake, representing adherence to Mediterranean diet intake.Main Outcomes and Measures  Incident cases of type 2 diabetes, identified through annual questionnaires; reported cases were confirmed by either telephone interview or supplemental questionnaire. Proportion of reduced risk of type 2 diabetes explained by clinical risk factors and a panel of 40 biomarkers that represent different physiological pathways was estimated.Results  The mean (SD) age of the 25 317 female participants was 52.9 (9.9) years, and they were followed up for a mean (SD) of 19.8 (5.8) years. Higher baseline MED intake (score ≥6 vs ≤3) was associated with as much as a 30% lower type 2 diabetes risk (age-adjusted and energy-adjusted hazard ratio, 0.70; 95% CI, 0.62-0.79; when regression models were additionally adjusted with body mass index [BMI]: hazard ratio, 0.85; 95% CI, 0.76-0.96). Biomarkers of insulin resistance made the largest contribution to lower risk (accounting for 65.5% of the MED–type 2 diabetes association), followed by BMI (55.5%), high-density lipoprotein measures (53.0%), and inflammation (52.5%), with lesser contributions from branched-chain amino acids (34.5%), very low-density lipoprotein measures (32.0%), low-density lipoprotein measures (31.0%), blood pressure (29.0%), and apolipoproteins (23.5%), and minimal contribution (≤2%) from hemoglobin A1c. In post hoc subgroup analyses, the inverse association of MED diet with type 2 diabetes was seen only among women who had BMI of at least 25 at baseline but not those who had BMI of less than 25 (eg, women with BMI <25, age- and energy-adjusted HR for MED score ≥6 vs ≤3, 1.01; 95% CI, 0.77-1.33; P for trend = .92; women with BMI ≥25: HR, 0.76; 95% CI, 0.67-0.87; P for trend < .001).Conclusions and Relevance  In this cohort study, higher MED intake scores were associated with a 30% relative risk reduction in type 2 diabetes during a 20-year period, which could be explained in large part by biomarkers of insulin resistance, BMI, lipoprotein metabolism, and inflammation.
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3.
  • Ahmad, Shafqat, et al. (författare)
  • Mediterranean Diet Adherence and Risk of All-Cause Mortality in Women
  • 2024
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 7:5
  • 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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4.
  • Alaie, Iman, et al. (författare)
  • Associations of Internalizing and Externalizing Problems in Childhood and Adolescence With Adult Labor Market Marginalization
  • 2023
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 6:6
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE Mental health problems in early life are associated with labor market marginalization, especially in youths with persistent internalizing and externalizing problems. However, previous research has not adjusted for familial (genetic and shared environmental) factors.OBJECTIVE To examine associations of early-life internalizing and externalizing problems with adulthood unemployment and work disability, adjusting for familial factors.DESIGN, SETTING, AND PARTICIPANTS This population-based prospective cohort study included Swedish twins whowere born in 1985-1986 and surveyed at 4 consecutivewaves across childhood and adolescence until 2005. Through linkage to nationwide registries, participants were followed up from 2006 to 2018. Data analyses were conducted between September 2022 and April 2023.EXPOSURES Internalizing and externalizing problems, assessed with the Child Behavior Checklist. Participants were differentiated regarding duration of internalizing and externalizing problems (persistent, episodic, and noncases).MAIN OUTCOMES AND MEASURES Unemployment (180 days or more of being unemployed) and work disability (60 days or more of being sickness absent or disability pensioned) during follow-up. Cox proportional hazards regression models were calculated to obtain cause-specific hazard ratios (HRs) with 95% CIs in the whole cohort and exposure-discordant twin pairs.RESULTS Of 2845 participants, 1464 (51.5%) were female. Incident unemployment was experienced by 944 (33.2%) and incidentwork disability by 522 (18.3%) participants. Compared with noncases, persistent internalizing problemswere associated with unemployment (HR, 1.56; 95% CI, 1.27-1.92) and work disability (HR, 2.32; 95% CI, 1.80-2.99). Similarly, compared with noncases, persistent externalizing problems were associated with unemployment (HR, 1.87; 95% CI, 1.55-2.26) andwork disability (HR, 2.38; 95% CI, 1.87-3.03). Persistent cases had overall higher risks of adverse outcomes than episodic cases. After adjustment for familial factors, associations with unemployment were no longer statistically significant, whereas associations with work disability remained or were only slightly reduced.CONCLUSIONS AND RELEVANCE In this cohort study of young Swedish twins, familial factors explained the associations between early-life persistent internalizing and externalizing problems and unemployment; such factors were comparatively less important for the association with work disability. This suggests nonshared environmental factors may be important for the risk of future work disability among young individuals with persistent internalizing and externalizing problems.
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5.
  • Alken, Jenny, et al. (författare)
  • Rates of Extreme Neonatal Hyperbilirubinemia and Kernicterus in Children and Adherence to National Guidelines for Screening, Diagnosis, and Treatment in Sweden
  • 2019
  • Ingår i: JAMA Network Open. - : AMER MEDICAL ASSOC. - 2574-3805. ; 2:3
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE Neonatal hyperbilirubinemia can cause lifelong neurodevelopmental impairment (kernicterus) even in high-resource settings. A better understanding of the incidence and processes leading to kernicterus may help in the design of preventive measures. OBJECTIVES To determine incidence rates of hazardous hyperbilirubinemia and kernicterus among near-term to term newborns and to evaluate health care professional adherence to best practices. DESIGN, SETTING, AND PARTICIPANTS This population-based nationwide cohort study used prospectively collected data on the highest serum bilirubin level for all infants born alive at 35 weeks' gestation or longer and admitted to neonatal care at all 46 delivery and 37 neonatal units in Sweden from 2008 to 2016. Medical records for newborns with hazardous hyperbilirubinemia were evaluated for best neonatal practices and for a diagnosis of kernicterus up to 2 years of age. Data analyses were performed between September 2017 and February 2018. EXPOSURES Extreme (serum bilirubin levels, 25.0-29.9mg/dL [425-509 mu mol/L]) and hazardous (serum bilirubin levels, >30.0mg/dL [>510 mu mol/L]) neonatal hyperbilirubinemia. MAIN OUTCOMES AND MEASURES The primary outcome was kernicterus, defined as hazardous neonatal hyperbilirubinemia followed by cerebral palsy, sensorineural hearing loss, gaze paralysis, or neurodevelopmental retardation. Secondary outcomeswere health care professional adherence to national guidelines using a predefined protocol with 10 key performance indicators for diagnosis and treatment as well as assessment of whether bilirubin-associated brain damage might have been avoidable. RESULTS Among 992 378 live-born infants (958 051 term births and 34 327 near-term births), 494 (320 boys; mean [SD] birth weight, 3505 [527] g) developed extreme hyperbilirubinemia (50 per 100 000 infants), 6.8 per 100 000 infants developed hazardous hyperbilirubinemia, and 1.3 per 100 000 infants developed kernicterus. Among 13 children developing kernicterus, brain injury was assessed as potentially avoidable for 11 children based on the presence of 1 or several of the following possible causes: untimely or lack of predischarge bilirubin screening (n = 6), misinterpretation of bilirubin values (n = 2), untimely or delayed initiation of treatment with intensive phototherapy (n = 1), untimely or no treatment with exchange transfusion (n = 6), or lack of repeated exchange transfusions despite indication (n = 1). CONCLUSIONS AND RELEVANCE Hazardous hyperbilirubinemia in near-term or term newborns still occurs in Sweden and was associated with disabling brain damage in 13 per million births. For most of these cases, health care professional noncompliance with best practices was identified, suggesting that a substantial proportion of these cases might have been avoided.
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6.
  • Almquist, Ylva B., et al. (författare)
  • Association of Child Placement in Out-of-Home Care With Trajectories of Hospitalization Because of Suicide Attempts From Early to Late Adulthood
  • 2020
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 3:6
  • Tidskriftsartikel (refereegranskat)abstract
    • Importance Children placed in out-of-home care (OHC) have higher rates of suicidal behaviors, including suicide attempts, compared with those who grow up in their family of origin. Several studies have shown that this elevated risk persists into young adulthood. Yet, our knowledge about any longer-term associations of OHC with suicide attempts is limited. Objective To examine how childhood experiences of placement in OHC are associated with trajectories of hospitalization because of suicide attempts (HSA) from early into late adulthood. Design, Setting, and Participants This prospective birth cohort study that was conducted in Stockholm, Sweden, and analyzed in March 2020 included 14559 individuals born in 1953 who were living in the greater metropolitan of Stockholm in November 1963 and followed through registers up until December 2016. Exposures Childhood experiences of OHC based on information from the Social Register (age 0-19 years). Main Outcomes and Measures Hospitalization because of suicide attempts based on in-patient care data from the National Patient Register. Group-based trajectory modeling was used to cluster individuals according to their probabilities of HSA across adulthood (age 20-63 years). Results In this cohort of 14559 individuals (7146 women [49.1%]), 1320 individuals (9.1%) had childhood experiences of OHC, whereas 525 individuals ( 3.6%) had HSA. A Cox regression analysis showed a substantially higher risk of HSA among those with childhood experiences of OHC (hazard ratio, 3.58; 95% CI, 2.93-4.36) and after adjusting for a range of adverse childhood living conditions (hazard ratio, 2.51; 95% CI, 2.00-3.15). Those with at least 1 HSA were grouped into 4 trajectories: (1) peak in middle adulthood (66 [12.6%]), (2) stable low across adulthood (167 [31.8%]), (3) peak in early adulthood (210 [40.0%]), and (4) peak in emerging adulthood (82 [15.6%]). A multinomial regression analysis suggested that those with experiences of OHC had higher risks of following any of these trajectories (trajectory 1: relative risk ratio [RRR], 2.91; 95% CI, 1.61-5.26; trajectory 2: RRR, 3.18; 95% CI, 2.21-4.59; trajectory 3: RRR, 4.32; 95% CI, 3.18-5.86; trajectory 4: RRR, 3.26; 95% CI, 1.94-5.46). The estimates were reduced after adjusting for adverse childhood living conditions. Conclusions and Relevance The findings suggest that the elevated risk of suicide attempts among former child welfare clients does not cease after young adulthood, indicating the necessity for clinical attention to childhood experiences of OHC as a risk marker for suicidal behavior across the life span. Question How are childhood experiences of placement in out-of-home care associated with trajectories of hospitalization because of suicide attempts from early into late adulthood? Findings In this cohort study of 14559 individuals, individuals were grouped into 4 trajectories with differential onset of suicide attempts across adulthood. Childhood experiences of placement in out-of-home care were associated with increased risks of following each of these trajectories. Meaning The elevated risk of suicide attempts among former child welfare clients persists into young adulthood, indicating the necessity for clinical attention to childhood experiences of out-of-home care as a risk marker for suicidal behavior across the life span. This cohort study examines the association between childhood experiences of placement in out-of-home care and trajectories of hospitalization because of suicide attempts from early into late adulthood in Sweden.
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7.
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8.
  • Andrén, Per, et al. (författare)
  • Internet-Delivered Exposure and Response Prevention for Pediatric Tourette Syndrome : 12-Month Follow-Up of a Randomized Clinical Trial
  • 2024
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 7:5
  • 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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9.
  • Andrén, Per, et al. (författare)
  • Therapist-Supported Internet-Delivered Exposure and Response Prevention for Children and Adolescents with Tourette Syndrome : A Randomized Clinical Trial
  • 2022
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 5:8
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE: The availability of behavior therapy for individuals with Tourette syndrome (TS) and chronic tic disorder (CTD) is limited.OBJECTIVE: To determine the efficacy and cost-effectiveness of internet-delivered exposure and response prevention (ERP) for children and adolescents with TS or CTD.DESIGN, SETTING, AND PARTICIPANTS: This single-masked, parallel group, superiority randomized clinical trial with nationwide recruitment was conducted at a research clinic in Stockholm, Sweden. Out of 615 individuals assessed for eligibility, 221 participants meeting diagnostic criteria for TS or CTD and aged 9 to 17 years were included in the study. Enrollment began in April 2019 and ended in April 2021. Data were analyzed between October 2021 and March 2022.INTERVENTIONS: Participants were randomized to 10 weeks of therapist-supported internet-delivered ERP for tics (111 participants) or to therapist-supported internet-delivered education for tics (comparator group, 110 participants).MAIN OUTCOMES AND MEASURES: The primary outcome was change in tic severity from baseline to the 3-month follow-up as measured by the Total Tic Severity Score of the Yale Global Tic Severity Scale (YGTSS-TTSS). YGTSS-TTSS assessors were masked to treatment allocation. Treatment response was operationalized as a score of 1 ("Very much improved") or 2 ("Much improved") on the Clinical Global Impression-Improvement scale.RESULTS: Data loss was minimal, with 216 of 221 participants (97.7%) providing primary outcome data. Among randomized participants (152 [68.8%] boys; mean [SD] age, 12.1 [2.3] years), tic severity improved significantly, with a mean reduction of 6.08 points on the YGTSS-TTSS in the ERP group (mean [SD] at baseline, 22.25 [5.60]; at 3-month follow-up, 16.17 [6.82]) and 5.29 in the comparator (mean [SD] at baseline, 23.01 [5.92]; at 3-month follow-up, 17.72 [7.11]). Intention-to-treat analyses showed that the 2 groups improved similarly over time (interaction effect, -0.53; 95% CI, -1.28 to 0.22; P = .17). Significantly more participants were classified as treatment responders in the ERP group (51 of 108 [47.2%]) than in the comparator group (31 of 108 [28.7%]) at the 3-month follow-up (odds ratio, 2.22; 95% CI, 1.27 to 3.90). ERP resulted in more treatment responders at little additional cost compared with structured education. The incremental cost per quality-adjusted life-year gained was below the Swedish willingness-to-pay threshold, at which ERP had a 66% to 76% probability of being cost-effective.CONCLUSIONS AND RELEVANCE: Both interventions were associated with clinically meaningful improvements in tic severity, but ERP led to higher response rates at little additional cost.TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03916055.
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10.
  • Ashley, Thomas, et al. (författare)
  • Outcomes After Elective Inguinal Hernia Repair Performed by Associate Clinicians vs Medical Doctors in Sierra Leone A Randomized Clinical Trial
  • 2021
  • Ingår i: JAMA Network Open. - : American Medical Association. - 2574-3805. ; 4:1
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE Task sharing of surgical duties with medical doctors (MDs) without formal surgical training and associate clinicians (ACs; health care workers corresponding to an educational level between that of a nurse and an MD) is practiced to provide surgical services to people in low-resource settings. The safety and effectiveness of this has not been fully evaluated through a randomized clinical trial. OBJECTIVE To determine whether task sharing with MDs and ACs is safe and effective in mesh hernia repair in Sierra Leone. DESIGN, SETTING, AND PARTICIPANTS This single-blind, noninferiority randomized clinical trial included adult, healthy men with primary inguinal hernia randomized to receiving surgical treatment from an MD or an AC. In Sierra Leone, ACs practicing surgery have received 2 years of surgical training and completed a 1-year internship. The study was conducted between October 2017 and February 2019. Patients were followed up at 2 weeks and 1 year after operations. Observers were blinded to the study arm of the patients. The study was carried out in a first-level hospital in rural Sierra Leone. Data were analyzed from March to June 2019. INTERVENTIONS All patients received an open mesh inguinal hernia repair under local anesthesia. The control group underwent operations performed by MDs, and the intervention group underwent operations performed by ACs. MAIN OUTCOMES AND MEASURES The primary end point was hernia recurrence at 1 year. Outcomes were assessed by blinded observers at 2 weeks and 1 year after operations. RESULTS A total of 230 patients were recruited (mean [SD] age, 43.0 [13.5] years), and all but 1 patient underwent inguinal hernia repair between October 23, 2017, and February 2, 2018, performed by 5 MDs and 6 ACs. A total of 114 patients were operated on by MDs, and 115 patients were operated on by ACs. There were no crossovers between the study arms. The follow-up rate was 100% at 2 weeks and 94.1% at 1 year. At 1 year, hernia recurrence occurred in 7 patients (6.9%) operated on by MDs and 1 patient (0.9%) operated on by ACs (absolute difference, -6.0 [95% CI, -11.2 to 0.7] percentage points; P < .001). CONCLUSIONS AND RELEVANCE These findings demonstrate that task sharing of elective mesh inguinal hernia repair with ACs was safe and effective. The task sharing debate should progress to focus on optimizing surgical training programs for nonsurgeons and building capacity for elective surgical care in low- and middle-income countries.
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11.
  • Aspvall, K., et al. (författare)
  • Cost-effectiveness of Internet-Delivered vs In-Person Cognitive Behavioral Therapy for Children and Adolescents With Obsessive-Compulsive Disorder
  • 2021
  • Ingår i: JAMA network open. - : American Medical Association (AMA). - 2574-3805. ; 4:7
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE Therapist-guided, internet-delivered cognitive behavioral therapy is an effective treatment option for children and adolescents with obsessive-compulsive disorder, but to our knowledge, its cost-effectiveness compared with traditional in-person treatment has not been established. OBJECTIVE To evaluate the cost-effectiveness of guided internet-delivered cognitive behavioral therapy implemented within a stepped-care model compared with in-person cognitive behavioral therapy for young people with obsessive-compulsive disorder. DESIGN, SETTING, AND PARTICIPANTS This economic evaluation of a randomized noninferiority trial conducted at 2 specialist obsessive-compulsive disorder clinics in Sweden enrolled 152 children and adolescents aged 8 to 17 years with obsessive-compulsive disorder, mainly through clinician referrals (110 [72%]). Recruitment began October 6, 2017, and ended May 24, 2019. Follow-up ended April 14, 2020. INTERVENTIONS Participants were randomly assigned to receive either guided internet-delivered cognitive behavioral therapy or in-person cognitive behavioral therapy during a 16-week period. At the 3-month follow-up, nonresponders in both groups were offered additional in-person cognitive behavior therapy sessions. MAIN OUTCOMES AND MEASURES Health outcomes were treatment response rates (primary outcome), remission rates, and quality-adjusted life-years. Cost data were collected before treatment, after treatment, at 3-month follow-up, and at 6-month follow-up (primary end point) and are presented in 2020 US dollars. The differences in incremental costs and health outcomes were compared between the groups and presented from the health care professional, health care sector, and societal perspectives. RESULTS A total of 152 participants (94 girls [62%]; mean [SD] age, 13.4 [2.5] years) were randomized; 151 (99%) completed the trial. At the 6-month follow-up, 50 of 74 participants (68%) in the stepped-care group and 52 of 77 participants (68%) in the in-person cognitive behavioral therapy groupwere classified as treatment responders (odds ratio, 1.00 [95% CI, 0.51-1.98]; P=.99). Health economic analyses showed that the stepped-care group used fewer therapist resources than the in-person cognitive behavioral therapy group, resulting in a mean cost savings of $2104 (95% CI, $1202-$3006) per participant for the full study period of 10 months, corresponding to a relative savings of 39%. The cost savings remained largely comparable when taking wider health care sector and societal perspectives. CONCLUSIONS AND RELEVANCE This study suggests that, for young people with obsessive-compulsive disorder, a low-cost digital intervention followed by in-person treatment for nonresponders was cost-effective compared with in-person cognitive behavior therapy alone.
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12.
  • Aspvall, K., et al. (författare)
  • Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder A Trial Protocol for a Randomized Noninferiority Trial
  • 2019
  • Ingår i: Jama Network Open. - : American Medical Association (AMA). - 2574-3805. ; 2:10
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations. OBJECTIVE To investigate whether internet-delivered cognitive behavior therapy implemented within a stepped care model is noninferior to, and cost-effective compared with, the gold standard of face-to-face cognitive behavior therapy for pediatric obsessive-compulsive disorder. DESIGN, SETTING, AND PARTICIPANTS Multicenter, single-blind, randomized clinical noninferiority trial implemented at 2 specialist pediatric obsessive-compulsive disorder clinics in Stockholm and Gothenburg, Sweden. Participants are 152 children and adolescents aged 7 to 17 years with obsessive compulsive disorder, recruited through the 2 clinics and online self-referral. Patients will be randomized 1:1 to the stepped care intervention or face-to-face therapy. Blind evaluations will be conducted after treatment and at 3-month and 6-month follow-ups. At the 6-month follow-up (primary end point), noninferiority will be tested and resource use will be compared between the 2 treatment groups. Data will be analyzed according to intention-to-treat principles. INTERVENTION Patients randomized to stepped care will first receive internet-delivered cognitive behavior therapy for 16 weeks; patients who are classified as nonresponders 3 months after treatment completion will receive additional face-to-face therapy. The control group will receive 16 weeks of face-to-face cognitive behavior therapy immediately following randomization and nonresponders at the 3-month follow-up will, as in the stepped care group, receive additional face-to-face therapy. MAIN OUTCOMES AND MEASURES Noninferiority is defined as a 4-point difference on the primary outcome measure (Children's Yale-Brown Obsessive Compulsive Scale). DISCUSSION Recruitment started October 6, 2017, and was completed May 24, 2019. Results from the primary end point will be available by May 2020. The naturalistic follow-ups (1, 2, and 5 years after the end of treatment) will continue to 2025. There are no interim analyses planned or stopping rules for the trial.
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  • Axelsson, Kristian F, 1973, et al. (författare)
  • Analysis of Comorbidities, Clinical Outcomes, and Parathyroidectomy in Adults With Primary Hyperparathyroidism
  • 2022
  • Ingår i: Jama Network Open. - : American Medical Association (AMA). - 2574-3805. ; 5:6
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE Patients with primary hyperparathyroidism (pHPT) appear to have an increased risk of fractures and other comorbidities, such as cardiovascular disease, although results from previous studies have been inconsistent. Evidence of the association of parathyroidectomy (PTX) with these outcomes is also limited because of the lack of large well-controlled trials. OBJECTIVE To investigate whether untreated pHPT was associated with an increased risk of incident fractures and cardiovascular events (CVEs) and whether PTX was associated with a reduced risk of these outcomes. DESIGN, SETTING, AND PARTICIPANTS This cohort study included all patients who were diagnosed with pHPT at hospitals in Sweden between July 1, 2006, and December 31, 2017. Each patient was matched with 10 control individuals from the general population by sex, birth year, and county of residence. The patients were followed up until December 31, 2017. Data analyses were performed from October 2021 to April 2022. MAIN OUTCOMES AND MEASURES The primary outcomes were fractures, CVEs, and death. Cumulative incidence of events was estimated using the 1-minus Kaplan-Meier estimator of corresponding survival function. Cox proportional hazards regression models were used to calculate hazard ratios (HRs). RESULTS A total of 16 374 patients with pHPT were identified (mean [SD] age, 67.5 [12.9] years; 12 806 women [78.2%]), with 163 740 control individuals. The follow-up time was 42 310 person-years for the pH PT group and 803 522 person-years for the control group. Compared with the control group, the pH PT group had a higher risk of any fracture (unadjusted HR, 1.39; 95% CI, 1.31-1.48), hip fracture (unadjusted HR, 1.51; 95% CI, 1.35-1.70), CVEs (unadjusted HR, 1.45; 95% CI, 1.34-1.57), and death (unadjusted HR, 1.72; 95% CI, 1.65-1.80). In a time-dependent Poisson regression model, PTX was associated with a reduced risk of any fracture (HR, 0.83; 95% CI, 0.75-0.93), hip fracture (HR, 0.78; 95% CI, 0.61-0.98), CVEs (HR, 0.84; 95% CI, 0.73-0.97), and death (HR, 0.59; 95% CI, 0.53-0.65). CONCLUSIONS AND RELEVANCE Results of this study suggest that pHPT is associated with increased risk of fractures, CVEs, and death, highlighting the importance of identifying patients with this condition to prevent serious unfavorable outcomes. The reduced risk of these outcomes associated with PTX suggests a clinical benefit of surgery.
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  • Axelsson, Kristian F, 1973, et al. (författare)
  • Comparison of Fractures Among Older Adults Who Are Ambulatory vs Those Who Use Wheelchairs in Sweden
  • 2023
  • Ingår i: JAMA NETWORK OPEN. - : American Medical Association (AMA). - 2574-3805. ; 6:2
  • Tidskriftsartikel (refereegranskat)abstract
    • ImportanceSeveral diseases and conditions, such as cerebrovascular disease, arthritis, previous fractures, neurological diseases, or amputation, can result in severe immobility justifying wheelchair use for increased mobility. Immobility results in disuse osteoporosis and is considered a risk factor for fracture, although there are no large cohort studies that have investigated fracture risk in patients who use wheelchairs compared with an ambulatory control group.ObjectiveTo investigate whether immobilized adults who used wheelchairs had a different risk of fracture and injurious falls compared with matched ambulatory controls.Design, Setting, and ParticipantsThis retrospective cohort study compared patients who used wheelchairs and controls (propensity score matched 1:1 using 22 variables relating to anthropometrics, general condition, comorbidity, and fall and fracture risk), identified through a national database of adults 65 years or older who underwent a health evaluation (baseline) at Swedish health care facilities. Patients were followed up from January 1, 2007, to December 31, 2017, and data analysis was performed between June 1 and 30, 2022.Main Outcomes and MeasuresIncident fracture, injurious falls without fracture, and deaths.ResultsA total of 55 442 adults using wheelchairs were included in the analysis (mean [SD] age, 83.2 [8.3] years; 60.5% women). Those who used wheelchairs and the 55 442 matched controls were followed up for a median of 2.0 (IQR, 0.5-3.2) and 2.3 (IQR, 0.8-3.6) years, respectively. Patients who used wheelchairs had a lower risk of any fracture (hazard ratio [HR], 0.43 [95% CI, 0.41-0.44]), major osteoporotic fracture (HR, 0.32 [95% CI, 0.31-0.33]), and hip fracture (HR, 0.30 [95% CI, 0.28-0.32]) compared with the ambulatory controls, associations that were only marginally affected by multivariable (same as the matching variables) adjustment. The risk of fall injury was lower among those who used wheelchairs than among ambulatory controls (unadjusted HR for Cox proportional hazards models, 0.48 [95% CI, 0.47-0.50]) and remained highly similar after adjustments. Patients who used wheelchairs had a significantly increased risk of death (HR, 1.35 [95% CI, 1.33-1.36]) compared with controls. Association between wheelchair use and fracture outcomes and injurious falls, calculated using a Fine and Gray model with death as a competing risk, was similar to associations obtained using Cox proportional hazards regression for all fracture outcomes.Conclusions and RelevanceIn this retrospective cohort study of older adults, wheelchair use was associated with a lower risk of fracture than observed in ambulatory controls. These findings suggest that immobility associated with wheelchair use should not be considered a risk factor for fracture.
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15.
  • Ballin, Marcel, et al. (författare)
  • Genetic and Environmental Factors and Cardiovascular Disease Risk in Adolescents
  • 2023
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 6:11
  • Tidskriftsartikel (refereegranskat)abstract
    • Importance  Cardiovascular risk factors in youth have been associated with future cardiovascular disease (CVD), but conventional observational studies are vulnerable to genetic and environmental confounding.Objective  To examine the role of genetic and environmental factors shared by full siblings in the association of adolescent cardiovascular risk factors with future CVD.Design, Setting, and Participants  This is a nationwide cohort study with full sibling comparisons. All men who underwent mandatory military conscription examinations in Sweden between 1972 and 1995 were followed up until December 31, 2016. Data analysis was performed from May 1 to November 10, 2022.Exposures  Body mass index (BMI), cardiorespiratory fitness, blood pressure, handgrip strength, and a combined risk z score in late adolescence.Main Outcomes and Measures  The primary outcome was fatal or nonfatal CVD, as recorded in the National Inpatient Register or the Cause of Death Register before 2017.Results  A total of 1 138 833 men (mean [SD] age, 18.3 [0.8] years), of whom 463 995 were full brothers, were followed up for a median (IQR) of 32.1 (26.7-37.7) years, during which 48 606 experienced a CVD outcome (18 598 among full brothers). All risk factors were associated with CVD, but the effect of controlling for unobserved genetic and environmental factors shared by full siblings varied. In the sibling analysis, hazard ratios for CVD (top vs bottom decile) were 2.10 (95% CI, 1.90-2.32) for BMI, 0.77 (95% CI, 0.68-0.88) for cardiorespiratory fitness, 1.45 (95% CI, 1.32-1.60) for systolic blood pressure, 0.90 (95% CI, 0.82-0.99) for handgrip strength, and 2.19 (95% CI, 1.96-2.46) for the combined z score. The percentage attenuation in these hazard ratios in the sibling vs total cohort analysis ranged from 1.1% for handgrip strength to 40.0% for cardiorespiratory fitness. Consequently, in the sibling analysis, the difference in cumulative CVD incidence at age 60 years (top vs bottom decile) was 7.2% (95% CI, 5.9%-8.6%) for BMI and 1.8% (95% CI, 1.0%-2.5%) for cardiorespiratory fitness. Similarly, in the sibling analysis, hypothetically shifting everyone in the worst deciles of BMI to the middle decile would prevent 14.9% of CVD at age 60 years, whereas the corresponding number for cardiorespiratory fitness was 5.3%.Conclusions and Relevance  In this Swedish national cohort study, cardiovascular risk factors in late adolescence, especially a high BMI, were important targets for CVD prevention, independently of unobserved genetic and environmental factors shared by full siblings. However, the role of adolescent cardiorespiratory fitness in CVD may have been overstated by conventional observational studies.
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  • Bergengren, Oskar, et al. (författare)
  • Variation in Prostate-Specific Antigen Testing Rates and Prostate Cancer Treatments and Outcomes in a National 20-Year Cohort
  • 2021
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 4:5
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE: The diagnostic activity for prostate cancer has increased during the past decades. However, the benefit and harm of the increased diagnostic activity have not been quantified in detail for a country or a large region.OBJECTIVE: The aim of this study was to evaluate and quantify the association between increases in diagnostic activity driven by prostate-specific antigen testing and incidence of prostate cancer diagnosis, treatment, and mortality.DESIGN, SETTING, AND PARTICIPANTS: This cohort study used the Proxy-Based Risk-Stratified Incidence Simulation Model-Prostate Cancer to examine observed data on all Swedish men with prevalent prostate cancer and compare them with a corresponding, hypothetical, simulated scenario with more restrictive diagnostic activity. All men aged 40 to 100 years living in Sweden during the time period 1996 to 2016 with incident and prevalent prostate cancer were included. The second scenario is the corresponding, hypothetical, simulated scenario where diagnostic activity remained constant as of 1996 (the beginning of the prostate-specific antigen testing era) throughout the study period.EXPOSURES: High or low diagnostic activity for prostate cancer.MAIN OUTCOMES AND MEASURES: Incidence of prostate cancer diagnosis, treatment (deferred treatment, curative treatment, and hormonal treatment), and prostate cancer mortality.RESULTS: During the study period from 1996 to 2016, 188 884 men were diagnosed with prostate cancer at a median (interquartile range) age of 71 (64-77) years. Compared with the low-diagnostic activity scenario, in the high-diagnostic activity scenario, the number of men diagnosed with prostate cancer was 48% higher (423 vs 286 [95% CI, 271-302] per 100 000 men per year), 148% more men were diagnosed with low- or intermediate-risk cancer (221 vs 89 [95% CI, 73-105] per 100 000 men per year), and 108% more men received curative treatment (152 vs 73 [95% CI: 66-85] per 100 000 men per year). There were up to 15% fewer prostate cancer deaths in the scenario with high-diagnostic activity (incidence rate ratio, 0.85; 95% CI, 0.82-0.88).CONCLUSIONS AND RELEVANCE: This studys results suggest that increased prostate-specific antigen testing and diagnostic activity are associated with a larger number of men being diagnosed with prostate cancer, predominately with low- and intermediate-risk disease. The increased diagnostic activity was associated with a 2-fold increase in curative treatment and a modest decrease in mortality.
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21.
  • Beridze, G, et al. (författare)
  • Concordance and Discrepancies Among 5 Creatinine-Based Equations for Assessing Estimated Glomerular Filtration Rate in Older Adults
  • 2023
  • Ingår i: JAMA network open. - : American Medical Association (AMA). - 2574-3805. ; 6:3, s. e234211-
  • Tidskriftsartikel (refereegranskat)abstract
    • There is uncertainty as to which estimated glomerular filtration rate (eGFR) equation should be used among older adults.ObjectiveTo compare the 5 most commonly used creatinine-based eGFR equations in older adults, quantifying the concordance among the equations, comparing their discriminative capacity in regards to 15-year mortality, and identifying sources of potential discrepancies.Design, Setting, and ParticipantsThis cohort study used data from the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K), a longitudinal study of adults aged 60 years or older in Sweden. Participants were recruited between 2001 and 2004 and followed up for mortality until December 2016. Participants missing creatinine values were excluded. Data were originally analyzed March through July 2022, and were rerun in January 2023.ExposuresFive creatinine-based equations were considered: Modification of Diet in Renal Disease (MDRD), 2009 Chronic Kidney Disease Epidemiological Collaboration (CKD-EPI), Revised Lund-Malmö (RLM), Berlin Initiative Study (BIS), and European Kidney Function Consortium (EKFC).Main Outcomes and MeasuresConcordance between equations was quantified using Cohen κ. Discriminative capacity for mortality was quantified using area under the receiver operating characteristic curve (AUC) and the Harrel C statistic. Calf circumference, body mass index (BMI), and age were explored as correlates of discrepancies.ResultsThe study sample consisted of 3094 older adults (1972 [63.7%] female; median [IQR] age, 72 [66-81] years). Cohen κ between dyads of equations ranged from 0.42 to 0.91, with poorest concordance between MDRD and BIS, and best between RLM and EKFC. MDRD and CKD-EPI provided higher estimates of GFR compared with the other equations. The best mix of AUC and Harrel C statistic was observed for BIS (0.80 and 0.73, respectively); however, the prognostic accuracy for death decreased among those aged over 78 years and those with low calf circumference. Differences between equations were inconsistent across levels of calf circumference, BMI, and age.Conclusions and RelevanceIn this cohort study, we found that eGFR equations were not interchangeable when assessing kidney function. BIS outperformed other equations in predicting mortality; however, its discriminative capacity was reduced in subgroup analyses. Clinicians should consider these discrepancies when monitoring kidney function in old age.
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22.
  • Beridze, G, et al. (författare)
  • Concordance and Discrepancies Among 5 Creatinine-Based Equations for Assessing Estimated Glomerular Filtration Rate in Older Adults
  • 2023
  • Ingår i: JAMA network open. - : American Medical Association (AMA). - 2574-3805. ; 6:3, s. e234211-
  • Tidskriftsartikel (refereegranskat)abstract
    • There is uncertainty as to which estimated glomerular filtration rate (eGFR) equation should be used among older adults.ObjectiveTo compare the 5 most commonly used creatinine-based eGFR equations in older adults, quantifying the concordance among the equations, comparing their discriminative capacity in regards to 15-year mortality, and identifying sources of potential discrepancies.Design, Setting, and ParticipantsThis cohort study used data from the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K), a longitudinal study of adults aged 60 years or older in Sweden. Participants were recruited between 2001 and 2004 and followed up for mortality until December 2016. Participants missing creatinine values were excluded. Data were originally analyzed March through July 2022, and were rerun in January 2023.ExposuresFive creatinine-based equations were considered: Modification of Diet in Renal Disease (MDRD), 2009 Chronic Kidney Disease Epidemiological Collaboration (CKD-EPI), Revised Lund-Malmö (RLM), Berlin Initiative Study (BIS), and European Kidney Function Consortium (EKFC).Main Outcomes and MeasuresConcordance between equations was quantified using Cohen κ. Discriminative capacity for mortality was quantified using area under the receiver operating characteristic curve (AUC) and the Harrel C statistic. Calf circumference, body mass index (BMI), and age were explored as correlates of discrepancies.ResultsThe study sample consisted of 3094 older adults (1972 [63.7%] female; median [IQR] age, 72 [66-81] years). Cohen κ between dyads of equations ranged from 0.42 to 0.91, with poorest concordance between MDRD and BIS, and best between RLM and EKFC. MDRD and CKD-EPI provided higher estimates of GFR compared with the other equations. The best mix of AUC and Harrel C statistic was observed for BIS (0.80 and 0.73, respectively); however, the prognostic accuracy for death decreased among those aged over 78 years and those with low calf circumference. Differences between equations were inconsistent across levels of calf circumference, BMI, and age.Conclusions and RelevanceIn this cohort study, we found that eGFR equations were not interchangeable when assessing kidney function. BIS outperformed other equations in predicting mortality; however, its discriminative capacity was reduced in subgroup analyses. Clinicians should consider these discrepancies when monitoring kidney function in old age.
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23.
  • Bjureberg, Johan, et al. (författare)
  • Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder : A Randomized Clinical Trial
  • 2023
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 6:7
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE: Nonsuicidal self-injury is prevalent in adolescence and associated with adverse clinical outcomes. Effective interventions that are brief, transportable, and scalable are lacking.OBJECTIVE: To test the hypotheses that an internet-delivered emotion regulation individual therapy for adolescents delivered adjunctive to treatment as usual is superior to treatment as usual only in reducing nonsuicidal self-injury and that improvements in emotion regulation mediate these treatment effects.DESIGN, SETTING, AND PARTICIPANTS: This 3-site, single-masked, randomized superiority trial enrolled participants from November 20, 2017, to April 9, 2020. Eligible participants were aged between 13 and 17 years and met diagnostic criteria for nonsuicidal self-injury disorder; they were enrolled as a mixed cohort of consecutive patients and volunteers. Parents participated in parallel to their children. The primary end point was at 1 month after treatment. Participants were followed up at 3 months posttreatment. Data collection ended in January 2021.INTERVENTIONS: Twelve weeks of therapist-guided, internet-delivered emotion regulation individual therapy delivered adjunctive to treatment as usual vs treatment as usual only.MAIN OUTCOMES AND MEASURES: Primary outcome was the youth version of the Deliberate Self-harm Inventory, both self-reported by participants prior to treatment, once every week during treatment, and for 4 weeks posttreatment, and clinician-rated by masked assessors prior to treatment and at 1 and 3 months posttreatment.RESULTS: A total of 166 adolescents (mean [SD] age, 15.0 [1.2] years; 154 [92.8%] female) were randomized to internet-delivered emotion regulation therapy plus treatment as usual (84 participants) or treatment as usual only (82 participants). The experimental intervention was superior to the control condition in reducing clinician-rated nonsuicidal self-injury (82% vs 47% reduction; incidence rate ratio, 0.34; 95% CI, 0.20-0.57) from pretreatment to 1-month posttreatment. These results were maintained at 3-month posttreatment. Improvements in emotion dysregulation mediated improvements in self-injury during treatment.CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, a 12-week, therapist-guided, internet-delivered emotion regulation therapy delivered adjunctive to treatment as usual was efficacious in reducing self-injury, and mediation analysis supported the theorized role of emotion regulation as the mechanism of change in this treatment. This treatment may increase availability of evidence-based psychological treatments for adolescents with nonsuicidal self-injury.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03353961.
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24.
  • Björk-Eriksson, Thomas, 1960, et al. (författare)
  • Mortality Among Pediatric Patients With Acute Lymphoblastic Leukemia in Sweden From 1988 to 2017
  • 2022
  • Ingår i: JAMA network open. - : American Medical Association (AMA). - 2574-3805. ; 5:11
  • Tidskriftsartikel (refereegranskat)abstract
    • Importance: Acute lymphoblastic leukemia (ALL) constitutes 20% to 30% of all pediatric cancers. The 5-year overall survival among pediatric patients with ALL in high-income countries such as Sweden is currently more than 90%, but long-term unselected nationwide mortality data and mortality data in relation to the general population are lacking. Objective: To compare mortality between pediatric patients with ALL and the general population during a 30-year period in Sweden and to assess the incidence of ALL in Sweden. Design, Setting, and Participants: This cohort study included pediatric patients (aged <18 years) with a morphologically verified ALL diagnosis in the Swedish Cancer Register and/or at least 2 ALL diagnoses in the Swedish National Patient Register between January 1, 1988, and December 31, 2017. Data were cross-linked to the Swedish Cause of Death Register. Data were analyzed from May 2019 to January 2022. Main Outcomes and Measures: The main outcomes were mortality among patients with ALL compared with that in the general population and mortality in different subgroups within the cohort. Standardized mortality ratios (SMRs) were calculated using the general Swedish population as a reference. Within-cohort survival analyses were performed. Results: A total of 2397 patients (1354 [56%] male; mean [SD] age at diagnosis, 6.1 [4.7] years) were included in the study. The mean (SD) incidence of pediatric ALL during the study period was 4.11 (0.60) cases per 100 000 persons per year (females, 3.68 [0.65] cases per 100 000 persons per year; males, 4.52 [0.81] cases per 100 000 persons per year; P<.001). The observed number of deaths among pediatric patients with ALL was 409 vs the 9.5 deaths expected in the general population, resulting in an overall SMR of 43.1 (95% CI, 39.0-47.5); females had a higher SMR than males (57.8 [95% CI, 49.5-67.2] vs 34.5 [95% CI, 32.0-41.4]; P<.001). Analysis within the cohort showed a continued decrease in survival throughout the 30-year follow-up. The association between calendar year of ALL diagnosis, corresponding with different ALL treatment protocols, and mortality showed the lowest survival for the 1988-1991 group and the highest for the 2008-2017 group (χ2=20.3; P<.001). Conclusions and Relevance: In this cohort study, a consistently high SMR was seen among pediatric patients with ALL. Within the ALL cohort, survival evolved to a similar extent as in the young general population of Sweden. Furthermore, survival among patients with ALL decreased throughout the whole follow-up period without any trend difference after the 5-year follow-up time point. The changes in ALL treatment protocols were associated with overall improved absolute survival over time.
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25.
  • Björklund, Erik, et al. (författare)
  • Comparison of Midterm Outcomes Associated With Aspirin and Ticagrelor vs Aspirin Monotherapy After Coronary Artery Bypass Grafting for Acute Coronary Syndrome.
  • 2021
  • Ingår i: JAMA network open. - : American Medical Association (AMA). - 2574-3805. ; 4:8
  • Tidskriftsartikel (refereegranskat)abstract
    • Guidelines recommend dual antiplatelet therapy after coronary artery bypass grafting (CABG) for patients with acute coronary syndrome (ACS). However, the evidence for these recommendations is weak.To compare midterm outcomes after CABG in patients with ACS treated postoperatively with acetylsalicylic acid (ASA) and ticagrelor or with ASA monotherapy.This cohort study used merged data from several national registries of Swedish patients who were diagnosed with ACS and subsequently underwent CABG. All included patients underwent isolated CABG in Sweden between 2012 and 2017 with an ACS diagnosis less than 6 weeks before the procedure, survived 14 days after discharge from hospital, and were treated postoperatively with ASA plus ticagrelor or ASA monotherapy. A multivariable Cox regression model was used for the main analysis, and propensity score-matched models were performed as sensitivity analysis. Data were analyzed between May and September 2020.Postoperative antiplatelet treatment, defined as filled prescriptions, with either ASA and ticagrelor or ASA only.Major adverse cardiovascular events (MACE), defined as all-cause mortality, myocardial infarction, and stroke, and major bleeding, at 12 months and at the end of follow-up.A total of 6558 patients (5281 [80.5%] men; mean [SD] age at surgery, 67.6 [9.3] years) were included; 1813 (27.6%) were treated with ASA plus ticagrelor and 4745 (72.4%) were treated with ASA monotherapy. Crude MACE rate was 3.0 per 100 person years (95% CI, 2.5-3.6 per 100 person years) in the ASA plus ticagrelor group and 3.8 per 100 person years (95% CI, 3.5-4.1 per 100 person years) in the ASA group. After adjustment, there was no significant difference in MACE risk between ASA plus ticagrelor vs ASA only, neither during the first 12 months (adjusted hazard ratio [aHR], 0.84; 95% CI, 0.58-1.21; P=.34) or during total follow-up (aHR, 0.89; 95% CI, 0.71-1.11; P=.29). The use of ASA plus ticagrelor was associated with a significantly increased risk for major bleeding during the first 12 months (aHR, 1.90; 95% CI, 1.16-3.13; P=.011). Sensitivity analyses confirmed the results.In patients with ACS who survived 2 weeks after CABG, no significant difference in the risk of death or ischemic events could be demonstrated between ASA plus ticagrelor and patients treated with ASA only, while the risk for major bleeding was higher in patients treated with ASA plus ticagrelor. Sufficiently powered prospective randomized trials comparing different antiplatelet therapy strategies after CABG are warranted.
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  • Blom, Johannes, et al. (författare)
  • Routine fecal occult blood screening and colorectal cancer mortality in Sweden
  • 2024
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 7:2
  • 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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30.
  • Bolk, Jenny, et al. (författare)
  • Association of Perinatal and Childhood Ischemic Stroke With Attention-Deficit/Hyperactivity Disorder
  • 2022
  • Ingår i: JAMA Network Open. - : American Medical Association. - 2574-3805. ; 5:4
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE Early detection of attention-deficit/hyperactivity disorder (ADHD) plays a crucial role in reducing negative effects on everyday life, including academic failure and poor social functioning. Children who survive ischemic strokes risk major disabilities, but their risk of ADHD has not been studied in nationwide cohorts. OBJECTIVE To assess the risk of ADHD in children after pediatric ischemic stroke. DESIGN, SETTING, AND PARTICIPANTS Participants in this Swedish nationwide cohort study included 1320 children diagnosed with ischemic stroke recorded in linked Swedish national registers from January 1, 1969, to December 31, 2016, without prior ADHD diagnosis. Ten matched controls were identified for each index case, and first-degree relatives were identified for index individuals and controls. Analyses were stratified by perinatal and childhood strokes and presence of comorbid adverse motor outcomes and/or epilepsy. End of follow-up was the date of ADHD diagnosis, death, or December 31, 2016, whichever occurred first. Data analyses were performed August 1 to 28, 2021. EXPOSURES Pediatric ischemic stroke. MAIN OUTCOMES AND MEASURES Attention-deficit/hyperactivity disorder identified using codes from the International Classification of Diseases, Ninth Revision, and international Statistical Classification of Diseases and Related Health Problems, Tenth Revision, and/or prescribed ADHD medication recorded in the Medical Birth Register, National Patient Register, or Prescribed Drug Register after stroke. Cox proportional hazards regression was used to assess adjusted hazard ratios (aHRs) for ADHD after pediatric stroke, adjusting for parental age and ADHD in first-degree relatives. RESULTS Of 1320 children with stroke included in the analysis (701 boys [53.1%]), 75 (45 boys [60.0%]) were diagnosed with ADHD after stroke compared with 376 (252 boys [67.0%]) among the controls (aHR, 2.00 [95% CI, 1.54-2.60]). The risk was increased after both perinatal (aHR, 2.75 [95% CI, 1.65-4.60]) and childhood (aHR, 1.82 [95% CI, 1.34-2.48]) strokes and were similar if children born preterm or small for gestational age were excluded. Compared with controls, risks of ADHD were higher among children with perinatal stroke and adverse motor outcomes and/or epilepsy (aHR, 6.17 [95% CI, 2.80-13.62]) than among those without these comorbidities (aHR, 1.65 [95% CI, 0.80-3.42]). However, findings were similar in childhood stroke for children with adverse motor outcomes and/or epilepsy (aHR, 1.80 [95% CI, 1.12-2.89]) and among those without these comorbidities (aHR, 1.92 [95% CI, 1.28-2.90]). CONCLUSIONS AND RELEVANCE This cohort study of 1320 children with pediatric ischemic stroke suggests that there is an increased risk of ADHD. particularly in children with adverse motor outcomes and/or epilepsy, compared with controls. The risk increases after childhood strokes regardless of comorbidities.
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31.
  • Bosi, A., et al. (författare)
  • Absolute and Relative Risks of Kidney Outcomes Associated With Lithium vs Valproate Use in Sweden
  • 2023
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 6:7
  • Tidskriftsartikel (refereegranskat)abstract
    • Importance Among patients with bipolar disorder, discordant findings have been published on the nephrotoxic effects of lithium therapy. Objective To quantify absolute and relative risks of chronic kidney disease (CKD) progression and acute kidney injury (AKI) in people who initiated lithium compared with valproate therapy and to investigate the association between cumulative use and elevated lithium levels and kidney outcomes. Design, Setting, and Participants This cohort study had a new-user active-comparator design and used inverse probability of treatment weights to minimize confounding. Included patients initiated therapy with lithium or valproate from January 1, 2007, to December 31, 2018, and had a median follow-up of 4.5 years (IQR, 1.9-8.0 years). Data analysis began in September 2021, using routine health care data from the period 2006 to 2019 from the Stockholm Creatinine Measurements project, a recurrent health care use cohort of all adult residents in Stockholm, Sweden. Exposures New use of lithium vs new use of valproate and high (>1.0 mmol/L) vs low serum lithium levels. Main Outcomes and Measures Progression of CKD (composite of >30% decrease relative to baseline estimated glomerular filtration rate [eGFR] and kidney failure), AKI (by diagnosis or transient creatinine elevations), new albuminuria, and annual eGFR decrease. Outcomes by attained lithium levels were also compared in lithium users. Results The study included 10946 people (median [IQR] age, 45 [32-59] years; 6227 female [56.9%]), of whom 5308 initiated lithium therapy and 5638 valproate therapy. During follow-up, 421 CKD progression events and 770 AKI events were identified. Compared with patients who received valproate, those who received lithium did not have increased risk of CKD (hazard ratio [HR], 1.11 [95% CI, 0.86-1.45]) or AKI (HR, 0.88 [95% CI, 0.70-1.10]). Absolute 10-year CKD risks were low and similar: 8.4% in the lithium group and 8.2% in the valproate group. No difference in the risk of developing albuminuria or the annual rate of eGFR decrease was found between groups. Among more than 35000 routine lithium tests, only 3% of results were in the toxic range (>1.0 mmol/L). Lithium values greater than 1.0 mmol/L, compared with lithium values of 1.0 mmol/L or less, were associated with increased risk of CKD progression (HR, 2.86; 95% CI, 0.97-8.45) and AKI (HR, 3.51; 95% CI, 1.41-8.76). Conclusions and Relevance In this cohort study, compared with new use of valproate, new use of lithium was meaningfully associated with adverse kidney outcomes, with low absolute risks that did not differ between therapies. However, elevated serum lithium levels were associated with future kidney risks, particularly AKI, emphasizing the need for close monitoring and lithium dose adjustment.
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33.
  • Brunström, Mattias, et al. (författare)
  • Association of physician education and feedback on hypertension management with patient blood pressure and hypertension control
  • 2020
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 3:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Elevated systolic blood pressure (SBP) is the most important risk factor for premature death worldwide. However, hypertension detection and control rates continue to be suboptimal.To assess the association of education and feedback to primary care physicians with population-level SBP and hypertension control rates.This pooled series of 108 population-based cohort studies involving 283 079 patients used data from primary care centers in 2 counties (Västerbotten and Södermanland) in Sweden from 2001 to 2009. Participants were individuals aged 18 years or older who had their blood pressure (BP) measured and recorded in either county during the intervention period. All analyses were performed in February 2019.An intervention comprising education and feedback for primary care physicians in Västerbotten County (intervention group) compared with usual care in Södermanland County (control group).Difference in mean SBP levels between counties and likelihood of hypertension control in the intervention county compared with the control county during 24 months of follow-up.A total of 136 541 unique individuals (mean [SD] age at inclusion, 64.6 [16.1] years; 57.0% female; mean inclusion BP, 142/82 mm Hg) in the intervention county were compared with 146 538 individuals (mean [SD] age at inclusion, 65.7 [15.9] years; 58.3% female; mean inclusion BP, 144/80 mm Hg) in the control county. Mean SBP difference between counties during follow-up, adjusted for inclusion BP and other covariates, was 1.1 mm Hg (95% CI, 1.0-1.1 mm Hg). Hypertension control improved by 8.4 percentage points, and control was achieved in 37.8% of participants in the intervention county compared with 29.4% in the control county (adjusted odds ratio, 1.30; 95% CI, 1.29-1.31). Differences between counties increased during the intervention period and were more pronounced in participants with higher SBP at inclusion. Results were consistent across all subgroups.This study suggests that SBP levels and hypertension control rates in a county population may be improved by educational approaches directed at physicians and other health care workers. Similar strategies may be adopted to reinforce the implementation of clinical practice guidelines for hypertension management.
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38.
  • Caprioglio, C, et al. (författare)
  • Analysis of Psychological Symptoms Following Disclosure of Amyloid-Positron Emission Tomography Imaging Results to Adults With Subjective Cognitive Decline
  • 2023
  • Ingår i: JAMA network open. - : American Medical Association (AMA). - 2574-3805. ; 6:1, s. e2250921-
  • Tidskriftsartikel (refereegranskat)abstract
    • Individuals who are amyloid-positive with subjective cognitive decline and clinical features increasing the likelihood of preclinical Alzheimer disease (SCD+) are at higher risk of developing dementia. Some individuals with SCD+ undergo amyloid-positron emission tomography (PET) as part of research studies and frequently wish to know their amyloid status; however, the disclosure of a positive amyloid-PET result might have psychological risks.ObjectiveTo assess the psychological outcomes of the amyloid-PET result disclosure in individuals with SCD+ and explore which variables are associated with a safer disclosure in individuals who are amyloid positive.Design, Setting, and ParticipantsThis prospective, multicenter study was conducted as part of The Amyloid Imaging to Prevent Alzheimer Disease Diagnostic and Patient Management Study (AMYPAD-DPMS) (recruitment period: from April 2018 to October 2020). The setting was 5 European memory clinics, and participants included patients with SCD+ who underwent amyloid-PET. Statistical analysis was performed from July to October 2022.ExposuresDisclosure of amyloid-PET result.Main Outcomes and MeasuresPsychological outcomes were defined as (1) disclosure related distress, assessed using the Impact of Event Scale–Revised (IES-R; scores of at least 33 indicate probable presence of posttraumatic stress disorder [PTSD]); and (2) anxiety and depression, assessed using the Hospital Anxiety and Depression scale (HADS; scores of at least 15 indicate probable presence of severe mood disorder symptoms).ResultsAfter disclosure, 27 patients with amyloid-positive SCD+ (median [IQR] age, 70 [66-74] years; gender: 14 men [52%]; median [IQR] education: 15 [13 to 17] years, median [IQR] Mini-Mental State Examination [MMSE] score, 29 [28 to 30]) had higher median (IQR) IES-R total score (10 [2 to 14] vs 0 [0 to 2]; P &amp;lt; .001), IES-R avoidance (0.00 [0.00 to 0.69] vs 0.00 [0.00 to 0.00]; P &amp;lt; .001), IES-R intrusions (0.50 [0.13 to 0.75] vs 0.00 [0.00 to 0.25]; P &amp;lt; .001), and IES-R hyperarousal (0.33 [0.00 to 0.67] vs 0.00 [0.00 to 0.00]; P &amp;lt; .001) scores than the 78 patients who were amyloid-negative (median [IQR], age, 67 [64 to 74] years, 45 men [58%], median [IQR] education: 15 [12 to 17] years, median [IQR] MMSE score: 29 [28 to 30]). There were no observed differences between amyloid-positive and amyloid-negative patients in the median (IQR) HADS Anxiety (–1.0 [–3.0 to 1.8] vs –2.0 [–4.8 to 1.0]; P = .06) and Depression (–1.0 [–2.0 to 0.0] vs –1.0 [–3.0 to 0.0]; P = .46) deltas (score after disclosure – scores at baseline). In patients with amyloid-positive SCD+, despite the small sample size, higher education was associated with lower disclosure-related distress (ρ = –0.43; P = .02) whereas the presence of study partner was associated with higher disclosure-related distress (W = 7.5; P = .03). No participants with amyloid-positive SCD+ showed probable presence of PTSD or severe anxiety or depression symptoms at follow-up.Conclusions and RelevanceThe disclosure of a positive amyloid-PET result to patients with SCD+ was associated with a bigger psychological change, yet such change did not reach the threshold for clinical concern.
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39.
  • Caprioglio, C, et al. (författare)
  • Analysis of Psychological Symptoms Following Disclosure of Amyloid-Positron Emission Tomography Imaging Results to Adults With Subjective Cognitive Decline
  • 2023
  • Ingår i: JAMA network open. - : American Medical Association (AMA). - 2574-3805. ; 6:1, s. e2250921-
  • Tidskriftsartikel (refereegranskat)abstract
    • Individuals who are amyloid-positive with subjective cognitive decline and clinical features increasing the likelihood of preclinical Alzheimer disease (SCD+) are at higher risk of developing dementia. Some individuals with SCD+ undergo amyloid-positron emission tomography (PET) as part of research studies and frequently wish to know their amyloid status; however, the disclosure of a positive amyloid-PET result might have psychological risks.ObjectiveTo assess the psychological outcomes of the amyloid-PET result disclosure in individuals with SCD+ and explore which variables are associated with a safer disclosure in individuals who are amyloid positive.Design, Setting, and ParticipantsThis prospective, multicenter study was conducted as part of The Amyloid Imaging to Prevent Alzheimer Disease Diagnostic and Patient Management Study (AMYPAD-DPMS) (recruitment period: from April 2018 to October 2020). The setting was 5 European memory clinics, and participants included patients with SCD+ who underwent amyloid-PET. Statistical analysis was performed from July to October 2022.ExposuresDisclosure of amyloid-PET result.Main Outcomes and MeasuresPsychological outcomes were defined as (1) disclosure related distress, assessed using the Impact of Event Scale–Revised (IES-R; scores of at least 33 indicate probable presence of posttraumatic stress disorder [PTSD]); and (2) anxiety and depression, assessed using the Hospital Anxiety and Depression scale (HADS; scores of at least 15 indicate probable presence of severe mood disorder symptoms).ResultsAfter disclosure, 27 patients with amyloid-positive SCD+ (median [IQR] age, 70 [66-74] years; gender: 14 men [52%]; median [IQR] education: 15 [13 to 17] years, median [IQR] Mini-Mental State Examination [MMSE] score, 29 [28 to 30]) had higher median (IQR) IES-R total score (10 [2 to 14] vs 0 [0 to 2]; P &amp;lt; .001), IES-R avoidance (0.00 [0.00 to 0.69] vs 0.00 [0.00 to 0.00]; P &amp;lt; .001), IES-R intrusions (0.50 [0.13 to 0.75] vs 0.00 [0.00 to 0.25]; P &amp;lt; .001), and IES-R hyperarousal (0.33 [0.00 to 0.67] vs 0.00 [0.00 to 0.00]; P &amp;lt; .001) scores than the 78 patients who were amyloid-negative (median [IQR], age, 67 [64 to 74] years, 45 men [58%], median [IQR] education: 15 [12 to 17] years, median [IQR] MMSE score: 29 [28 to 30]). There were no observed differences between amyloid-positive and amyloid-negative patients in the median (IQR) HADS Anxiety (–1.0 [–3.0 to 1.8] vs –2.0 [–4.8 to 1.0]; P = .06) and Depression (–1.0 [–2.0 to 0.0] vs –1.0 [–3.0 to 0.0]; P = .46) deltas (score after disclosure – scores at baseline). In patients with amyloid-positive SCD+, despite the small sample size, higher education was associated with lower disclosure-related distress (ρ = –0.43; P = .02) whereas the presence of study partner was associated with higher disclosure-related distress (W = 7.5; P = .03). No participants with amyloid-positive SCD+ showed probable presence of PTSD or severe anxiety or depression symptoms at follow-up.Conclusions and RelevanceThe disclosure of a positive amyloid-PET result to patients with SCD+ was associated with a bigger psychological change, yet such change did not reach the threshold for clinical concern.
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40.
  • Challis, Pontus, et al. (författare)
  • Association of Adherence to Surfactant Best Practice Uses with Clinical Outcomes among Neonates in Sweden
  • 2021
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 4:5
  • Tidskriftsartikel (refereegranskat)abstract
    • Importance: While surfactant therapy for respiratory distress syndrome (RDS) in preterm infants has been evaluated in clinical trials, less is known about how surfactant is used outside such a framework.Objective: To evaluate registered use, off-label use, and omissions of surfactant treatment by gestational age (GA) and associations with outcomes, mainly among very preterm infants (GA <32 weeks).Design, Setting, and Participants: This population-based cohort study used registry data for 97377 infants born in Sweden between 2009 and 2018. Infants did not have malformations and were admitted for neonatal care. Data analysis was conducted from June 2019 to June 2020.Exposures: Timing and number of surfactant administrations, off-label use, and omission of use. Registered use was defined by drug label (1-3 administrations for RDS). Omissions were defined as surfactant not administered despite mechanical ventilation for RDS.Main Outcome and Measures: In-hospital survival, pneumothorax, intraventricular hemorrhage grade 3 to 4, duration of mechanical ventilation, use of postnatal systemic corticosteroids for lung disease, treatment with supplemental oxygen at 28 days' postnatal age and at 36 weeks' postmenstrual age. Odds ratios (ORs) were calculated and adjusted for any prenatal corticosteroid treatment, cesarean delivery, GA, infant sex, Apgar score at 10 minutes, and birth weight z score of less than -2.Results: In total, 7980 surfactant administrations were given to 5209 infants (2233 [42.9%] girls; 2976 [57.1%] boys): 629 (12.1%) born at full term, 691 (13.3%) at 32 to 36 weeks' GA, 1544 (29.6%) at 28 to 31 weeks' GA, and 2345 (45.0%) at less than 28 weeks' GA. Overall, 977 infants (18.8%) received off-label use. In 1364 of 3508 infants (38.9%) with GA of 22 to 31 weeks, the first administration of surfactant was given more than 2 hours after birth, and this was associated with higher odds of pneumothorax (adjusted OR [aOR], 2.59; 95% CI, 1.76-3.83), intraventricular hemorrhage grades 3 to 4 (aOR, 1.71; 95% CI, 1.23-2.39), receipt of postnatal corticosteroids (aOR, 1.57; 95% CI, 1.22-2.03), and longer duration of assisted ventilation (aOR, 1.34; 95% CI, 1.04-1.72) but also higher survival (aOR, 1.45; 95% CI, 1.10-1.91) than among infants treated within 2 hours of birth. In 146 infants (2.8%), the recommended maximum of 3 surfactant administrations was exceeded but without associated improvements in outcome. Omission of surfactant treatment occurred in 203 of 3551 infants (5.7%) who were receiving mechanical ventilation and was associated with lower survival (aOR, 0.49; 95% CI, 0.30-0.82). In full-term infants, 336 (53.4%) of those receiving surfactant had a diagnosis of meconium aspiration syndrome. Surfactant for meconium aspiration was not associated with improved neonatal outcomes.Conclusions and Relevance: In this study, adherence to best practices and labels for surfactant use in newborn infants varied, with important clinical implications for neonatal outcomes.
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41.
  • Charalampidis, Anastasios, et al. (författare)
  • Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis
  • 2024
  • Ingår i: JAMA Network Open. - : AMER MEDICAL ASSOC. - 2574-3805. ; 7:1
  • 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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  • Chen, Hua, et al. (författare)
  • Death of a Parent and the Risk of Ischemic Heart Disease and Stroke in Denmark and Sweden
  • 2022
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 5:6
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE Increasing evidence suggests that parental death is associated with unhealthy behaviors and mental ill-health. Knowledge regarding the link between parental death and the risk of ischemic heart disease (IHD) and stroke remains limited.OBJECTIVES To investigate whether parental death is associated with an increased risk of IHD and stroke and whether these associations differ by the characteristics of the loss.DESIGN, SETTING, AND PARTICIPANTS This population-based cohort study, involving linkages between several nationwide registers, included 3 766 918 individuals born between 1973 and 1998 in Denmark and between 1973 and 1996 in Sweden. Participants were followed up until 2016 in Denmark and 2014 in Sweden. Data were analyzed from December 2019 to May 2021.EXPOSURES Death of a parent.MAIN OUTCOMES AND MEASURES Diagnosis with or death due to IHD or stroke. Poisson regression was used to analyze the associations between parental death and IHD and stroke risk.RESULTS Altogether, 48.8% of the participants were women, and 42.7% were from Denmark. A total of 523 496 individuals lost a parent during the study period (median age at loss, 25 years; IQR, 17-32 years). Parental death was associated with a 41% increased risk of IHD (incidence rate ratio [IRR], 1.41; 95% CI, 1.33-1.51) and a 30% increased risk of stroke [IRR, 1.30; 95% CI, 1.21-1.38). The associations were observed not only if the parent died because of cardiovascular or other natural causes but also in cases of unnatural deaths. The associations were stronger when both parents had died (IHD: IRR, 1.87; 95% CI, 1.59-2.21; stroke: IRR, 1.64; 95% CI, 1.35-1.98) than when 1 parent had died (IHD: IRR, 1.37; 95% CI, 1.28-1.47; stroke: IRR, 1.27; 95% CI, 1.19-1.36) but did not differ substantially by the offspring's age at loss or the deceased parents' sex. The risk of acute myocardial infarction was highest in the first 3 months after loss.CONCLUSIONS AND RELEVANCE In this cohort study, parental death in the first decades of life was associated with an increased risk of IHD and stroke. The associations were observed not only in cases of parental cardiovascular and other natural deaths but also in cases of unnatural deaths. Family members and health professionals may need to pay attention to the cardiovascular disease risk among parentally bereaved individuals.
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44.
  • Chen, Tianhui, et al. (författare)
  • Race and Ethnicity-Adjusted Age Recommendation for Initiating Breast Cancer Screening
  • 2023
  • Ingår i: JAMA Network Open. - 2574-3805. ; 6:4
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE: Breast cancer (BC) is the second leading cause of cancer death in women, and there is a substantial disparity in BC mortality by race, especially for early-onset BC in Black women. Many guidelines recommend starting BC screening from age 50 years; however, the current one-size-fits-all policy to start screening all women from a certain age may not be fair, equitable, or optimal.OBJECTIVE: To provide race and ethnicity-adapted starting ages of BC screening based on data on current racial and ethnic disparities in BC mortality.DESIGN, SETTING, AND PARTICIPANTS: This nationwide population-based cross-sectional study was conducted using data on BC mortality in female patients in the US who died of BC in 2011 to 2020.EXPOSURES: Proxy-reported race and ethnicity information was used. The risk-adapted starting age of BC screening by race and ethnicity was measured based on 10-year cumulative risk of BC-specific death. Age-specific 10-year cumulative risk was calculated based on age group-specific mortality data without modeling or adjustment.MAIN OUTCOMES AND MEASURES: Disease-specific mortality due to invasive BC in female patients.RESULTS: There were BC-specific deaths among 415 277 female patients (1880 American Indian or Alaska Native [0.5%], 12 086 Asian or Pacific Islander [2.9%], 62 695 Black [15.1%], 28 747 Hispanic [6.9%], and 309 869 White [74.6%]; 115 214 patients died before age 60 years [27.7%]) of any age in the US in 2011 to 2020. BC mortality per 100 000 person-years for ages 40 to 49 years was 27 deaths in Black females, 15 deaths in White females, and 11 deaths in American Indian or Alaska Native, Hispanic, and Asian or Pacific Islander females. When BC screening was recommended to start at age 50 years for all females with a 10-year cumulative risk of BC death of 0.329%, Black females reached this risk threshold level 8 years earlier, at age 42 years, whereas White females reached it at age 51 years, American Indian or Alaska Native and Hispanic females at age 57 years, and Asian or Pacific Islander females 11 years later, at age 61 years. Race and ethnicity-adapted starting ages for Black females were 6 years earlier for mass screening at age 40 years and 7 years earlier for mass screening at age 45 years.CONCLUSIONS AND RELEVANCE: This study provides evidence-based race-adapted starting ages for BC screening. These findings suggest that health policy makers may consider a risk-adapted approach to BC screening in which individuals who are at high risk are screened earlier to address mortality due to early-onset BC before the recommended age of mass screening.
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46.
  • Clausen, Henning, et al. (författare)
  • Evaluation of Circulating Cardiovascular Biomarker Levels for Early Detection of Congenital Heart Disease in Newborns in Sweden
  • 2020
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 3:12
  • Tidskriftsartikel (refereegranskat)abstract
    • Importance: Congenital heart disease (CHD) is the most common congenital malformation in humans worldwide. Circulating cardiovascular biomarkers could potentially improve the early detection of CHD, even in asymptomatic newborns. Objectives: To assess the performance of a dried blood spot (DBS) test to measure the cardiovascular biomarker amino terminal fragment of the prohormone brain-type natriuretic peptide (NT-proBNP) levels in newborns and to compare DBS with standard EDTA analysis in control newborns during the first week of life. Design, Setting, and Participants: This diagnostic study was conducted in a single regional pediatric service in southern Sweden. Healthy, term neonates born between July 1, 2018, and May 31, 2019, were prospectively enrolled and compared against retrospectively identified newborns with CHD born between September 1, 2003, and September 30, 2019. Neonates who required inpatient treatment beyond the standard postnatal care were excluded. Exposure: New DBS test for NT-proBNP quantification in newborns that used 3 μL of blood vs the current screening standard. Main Outcomes and Measures: Performance of the new test and when combined with pulse oximetry screening was measured by receiver operating characteristic curve analysis. Performance of the new test and EDTA screening was compared using Pearson linear correlation analysis. Results: The DBS samples of 115 neonates (81 control newborns and 34 newborns with CHD, of whom 63 were boys [55%] and the mean [SD] gestational age was 39.6 [1.4] weeks) were analyzed. The new NT-proBNP test alone identified 71% (n = 24 of 34) of all CHD cases and 68% (n = 13 of 19) of critical CHD cases as soon as 2 days after birth. Detection of any CHD type improved to 82% (n = 28 of 34 newborns) and detection of critical CHD improved to 89% (n = 17 of 19 newborns) when combined pulse oximetry screening and NT-proBNP test results were used. Performance of the NT-proBNP test was excellent when control newborns were matched to newborns with CHD born between July 1, 2018, and May 31, 2019 (area under the curve, 0.96; SE, 0.027; 95% CI, 0.908-1.0; asymptotic P < .05). Conclusions and Relevance: This study found that NT-proBNP assay using minimal DBS samples appears to be timely and accurate in detecting CHD in newborns and to discriminate well between healthy newborns and newborns with various types of CHD. This finding warrants further studies in larger cohorts and highlights the potential of NT-proBNP to improve neonatal CHD screening.
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47.
  • Clausen, Henning, et al. (författare)
  • Newborn Screening for High-Risk Congenital Heart Disease by Dried Blood Spot Biomarker Analysis.
  • 2024
  • Ingår i: JAMA Network Open. - 2574-3805. ; 7:6
  • 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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48.
  • Corsini, Christian, et al. (författare)
  • Survival Trend in Individuals With De Novo Metastatic Prostate Cancer After the Introduction of Doublet Therapy
  • 2023
  • Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 6:10
  • Tidskriftsartikel (refereegranskat)abstract
    • IMPORTANCE: Recently, life-prolonging treatments for patients with advanced prostate cancer have been introduced in clinical practice.OBJECTIVE: To investigate if the introduction of doublet therapy is associated with changes in survival on a population-basis.DESIGN, SETTING, AND PARTICIPANTS: This nationwide population-based cohort study used data from the Prostate Cancer data Base Sweden from 2008 to 2020. Men registered with de novo metastatic castration-sensitive prostate cancer (mCSPC) were included.EXPOSURE: The proportion of men with mCSPC who received doublet therapy, ie, androgen deprivation therapy plus androgen receptor pathway inhibitor drugs or chemotherapy was assessed.MAIN OUTCOMES AND MEASURES: Standardized overall survival, taking age, comorbidity, and cancer characteristics into consideration, was estimated by use of a parametric survival model.RESULTS: A total of 11 382 men were included in this study (median [IQR] age, 74.0 [68-81] years). There was a shift toward less advanced prostate cancer during the study period with a decrease in median (IQR) prostate-specific antigen at diagnosis in men with mCSPC from 145 (39-571) ng/mL to 107 (27-426) ng/mL. Upfront treatment with doublet therapy in these men simultaneously increased from 1% (7 of 991) in 2016 to 44% (402 of 922) in 2020. The adjusted 5-year overall survival increased from 26% (95% CI, 25%-28%) from 2008 to 2012 to 35% (95% CI, 31%-40%) from 2017 to 2020. During the first 5 years after diagnosis, there was an increase in mean survival of 6 months, from 2.7 (95% CI, 2.6-2.8) years from 2008 to 2012 to 3.2 (95% CI, 3.1-3.1) years from 2017 to 2020.CONCLUSIONS AND RELEVANCE: In parallel with improvements in treatment of advanced prostate cancer, a clinically meaningful increase in mean survival was observed in men with de novo mCSPC in Sweden between 2008 and 2020 in this study.
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49.
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