| 11. |
- Bhatt, Ankeet S., et al.
(author)
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Operational Challenges and Mitigation Measures during the COVID-19 Pandemic-Lessons from DELIVER.
- 2023
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In: American heart journal. ; 263, s. 133-140
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Journal article (peer-reviewed)abstract
- BACKGROUND: Catastrophic disruptions in care delivery threaten the operational efficiency and potentially the validity of clinical research efforts, in particular randomized clinical trials. Most recently, the COVID-19 pandemic affected essentially all aspects of care delivery and clinical research conduct. While consensus statements and clinical guidance documents have detailed potential mitigation measures, few real- world experiences detailing clinical trial adaptations to the COVID-19 pandemic exist, particularly among, large, global registrational cardiovascular trials. METHODS: We outline the operational impact of COVID-19 and resultant mitigation measures in the Dapagliflozin Evaluation to Improve the LIVEs of Patients with Preserved Ejection Fraction Heart Failure (DELIVER) trial, one of the largest and most globally diverse experiences with COVID-19 of any cardiovascular clinical trial to date. Specifically, we address the needed coordination between academic investigators, trial leadership, clinical sites, and the supporting sponsor to ensure the safety of participants and trial staff, to maintain the fidelity of trial operations, and to prospectively adapt statistical analyses plans to evaluate the impact of COVID-19 and the pandemic at large on trial participants. These discussions included key operational issues such as ensuring delivery of study medications, adaptations to study visits, enhanced COVID-19 related endpoint adjudication, and protocol and analytical plan revisions. CONCLUSION: Our findings may have important implications for establishing consensus on prospective contingency planning in future clinical trials. CLINICALTRIAL: gov: NCT03619213. CLINICALTRIAL: GOV: NCT03619213.
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| 12. |
- Björkelund, Cecilia, 1948, et al.
(author)
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Effects of adding early cooperation and a work-place dialogue meeting to primary care management for sick-listed patients with stress-related disorders: CO-WORK-CARE-Stress - a pragmatic cluster randomised controlled trial.
- 2024
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In: Scandinavian journal of primary health care. - 1502-7724. ; , s. 1-15
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Journal article (peer-reviewed)abstract
- To investigate whether intensified cooperation between general practitioner (GP), care manager and rehabilitation coordinator (RC) for patients sick-listed for stress-related mental disorder, combined with a person-centred dialogue meeting with employer, could reduce sick-leave days compared with usual care manager contact.Pragmatic cluster-randomised controlled trial, randomisation at primary care centre (PCC) level.PCCs in Region Västra Götaland, Sweden, with care manager organisation.Of 30 invited PCCs, 28 (93%) accepted the invitation and recruited 258 patients newly sick-listed due to stress-related mental disorder (n=142 intervention, n=116 control PCCs).Cooperation between GP, care manager and rehabilitation coordinator from start of illness notification plus a person-centred dialogue meeting between patient and employer within 3months. Regular contact with care manager was continued at the control PCCs.12-months net and gross number of sick-leave days. Secondary outcomes: Symptoms of stress, depression, anxiety; work ability and health related quality of life (EQ-5D) over 12months.There were no significant differences between intervention and control groups after 12months: days on sick-leave (12-months net sick-leave days, intervention, mean = 110.7days (95% confidence interval (CI) 82.6-138.8); control, mean = 99.1days (95% CI 73.9-124.3)), stress, depression, or anxiety symptoms, work ability or EQ-5D. There were no significant differences between intervention and control groups concerning proportion on sick-leave after 3, 6, 12months. At 3months 64.8% were on sick-leave in intervention group vs 54.3% in control group; 6months 38% vs 32.8%, and12 months 16.9% vs 15.5%.Increased cooperation at the PCC between GP, care manager and RC for stress-related mental disorder coupled with an early workplace contact in the form of a person-centred dialogue meeting does not reduce days of sick-leave or speed up rehabilitation.Trial registration: ClinicalTrials.gov Identifier: NCT03250026 https://clinicaltrials.gov/study/NCT03250026?tab=results#publicationsCO-WORK-CAREFirst Posted: August 15, 2017. Recruitment of PCCs: September 2017. Inclusion of patients from December 2017.
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| 13. |
- Björkelund, Cecilia, 1948, et al.
(author)
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Rehabilitation cooperation and person-centred dialogue meeting for patients sick-listed for common mental disorders: 12 months follow-up of sick leave days, symptoms of depression, anxiety, stress and work ability - a pragmatic cluster randomised controlled trial from the CO-WORK-CARE project.
- 2023
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In: BMJ open. - 2044-6055. ; 13:6
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Journal article (peer-reviewed)abstract
- To study whether early and enhanced cooperation within the primary care centres (PCC) combined with workplace cooperation via a person-centred employer dialogue meeting can reduce days on sick leave compared with usual care manager contact for patients on sick leave because of common mental disorders (CMD). Secondary aim: to study lapse of CMD symptoms, perceived Work Ability Index (WAI) and quality of life (QoL) during 12 months.Pragmatic cluster randomised controlled trial, randomisation at PCC level.28 PCCs in Region Västra Götaland, Sweden, with care manager organisation.30 PCCs were invited, 28 (93%) accepted invitation (14 intervention, 14 control) and recruited 341 patients newly sick-listed because of CMD (n=185 at intervention, n=156 at control PCCs).Complex intervention consisting of (1) early cooperation among general practitioner (GP), care manager and a rehabilitation coordinator, plus (2) a person-centred dialogue meeting between patient and employer within 3 months.regular contact with care manager.12 months net and gross number of sick leave days at group level.12 months depression, anxiety, stress symptoms, perceived WAI and QoL (EuroQoL-5 Dimensional, EQ-5D).No significant differences were found between intervention and control groups concerning days of sick leave (intervention net days of sick leave mean 102.48 (SE 13.76) vs control 96.29 (SE 12.38) p=0.73), return to work (HR 0.881, 95%CI 0.688 to 1.128), or CMD symptoms, WAI or EQ-5D after 12 months.It is not possible to speed up CMD patients' return to work or to reduce sick leave time by early and enhanced coordination among GP, care manager and a rehabilitation coordinator, combined with early workplace contact over and above what 'usual' care manager contact during 3 months provides.NCT03250026.
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| 14. |
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| 15. |
- Bondesson, Elisabeth, et al.
(author)
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Health care utilization among individuals who die by suicide as compared to the general population : a population-based register study in Sweden
- 2022
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In: BMC Public Health. - : Springer Science and Business Media LLC. - 1471-2458. ; 22:1
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Journal article (peer-reviewed)abstract
- BACKGROUND: Globally, 700 000 people die every year by suicide. Health care consultation patterns the period before suicide could be one potential way to identify people at risk for suicide. Therefore, this study examines health care patterns up to one year prior to the suicide by age, sex and prior diagnoses and specifically investigates if and how this differs from the general population of Skåne, Sweden.METHODS: This cohort study includes all individuals, aged 15 and older, that died by suicide in Region Skåne, Sweden from 2004 to 2015 (n = 1653). The individuals were identified through the Cause of death register and then linked to the Skåne healthcare register. Health care data was analyzed as proportions consulting different types of health care the month and year preceding the suicide, we also investigated the impact of age, sex and the occurrence of prior psychiatric and pain diagnoses. Additionally, we compared the proportion of consulting care among the suicide victims and the general population of Skåne.RESULTS: In the month before their death, 53% of the suicide victims had any health care consultation, compared with 20% in the general population of Skåne, a given month (p < 0.0001). The corresponding figures for the year prior to suicide was 86% among those who died by suicide, compared to 69% in the general population of Skåne, a given year (p < 0.0001). Women, and those having a documented history of psychiatric diagnosis were more likely to have health care consultations in the month and year preceding suicide (p < 0.001), compared to men and suicide victims without a history of psychiatric disease. Older adults that died by suicide, were less likely to consult psychiatric care compared to the younger suicide victims (p < 0.001).CONCLUSION: A majority of the suicide victims consulted health care in the near time before death and the proportion of seeking health care was significantly higher than in the general population of Skåne and higher among female suicide victims as compared to males. Alternative preventive screening measures should be considered for individuals consulting health care, especially for older people and individuals outside the psychiatric care.
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| 16. |
- Bondesson, Elisabeth, et al.
(author)
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Utilization of healthcare and prescription medicines after non-pharmacological interventions for depression - A 3-year register follow-up of an RCT in primary care
- 2022
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In: Preventive Medicine Reports. - : Elsevier. - 2211-3355. ; 25
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Journal article (peer-reviewed)abstract
- Depression is a common, recurrent disorder. There is a need for readily available treatments with few negative side effects, that demands little resources and that are effective both in the short- and long term. Our aim was to investigate the long-term effectiveness of two different interventions; physical exercise and internet-based cognitive behavioural therapy (internet-CBT), compared to usual care in patients with mild to moderate depression in a Swedish primary care setting. We performed a register-based 3-year follow-up study of participants in the randomized controlled trial REGASSA (n = 940) using healthcare utilization and dispensed medicines as outcomes. We found no difference between the three groups regarding proportion of participants consulting healthcare due to mental illness or pain during follow-up. Regarding number of consultations, there was no difference between the groups, except for consultations related to pain. For this outcome both treatment arms had significantly fewer consultations compared to usual care, during year 2-3, the risk ratio (RR) for physical exercise and internet-CBT was 0.64 (95% CI = 0.43-0.95) and 0.61 (95% CI = 0.41-0.90), respectively. A significantly lower proportion of patients in both treatment arms were dispensed hypnotics and sedatives year 2-3 compared to the usual care arm, RR for both physical exercise and internet-CBT was 0.72 (95% CI = 0.53-0.98). No other differences between the groups were found. In conclusion, considering long-term effects, both physical exercise and internet-CBT, being resource-efficient treatments, could be considered as appropriate additions for patients with mild to moderate depression in primary care settings.
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| 17. |
- Butt, Jawad H., et al.
(author)
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Atrial Fibrillation and Dapagliflozin Efficacy in Patients With Preserved or Mildly Reduced Ejection Fraction.
- 2022
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In: Journal of the American College of Cardiology. - : Elsevier BV. - 0735-1097. ; 80:18, s. 1705-1717
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Journal article (peer-reviewed)abstract
- BACKGROUND: Atrial fibrillation (AF) is common in heart failure (HF), is associated with worse outcomes compared with sinus rhythm, and may modify the effects of therapy. OBJECTIVES: This study examined the effects of dapagliflozin according to the presence or not of AF in the DELIVER (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure) trial. METHODS: A total of 6,263 patients with HF with New York Heart Association functional class II-IV, left ventricular ejection fraction $>$40%, evidence of structural heart disease, and elevated N-terminal pro-B-type natriuretic peptide levels were randomized to dapagliflozin or placebo. Clinical outcomes and the effect of dapagliflozin, according to AF status, were examined. The primary outcome was a composite of cardiovascular death or worsening HF. RESULTS: Of the 6,261 patients with data on baseline AF, 43.3% had no AF, 18.0% had paroxysmal AF, and 38.7% had persistent/permanent AF. The risk of the primary endpoint was higher in patients with AF, especially paroxysmal AF, driven by a higher rate of HF hospitalization: no AF, HF hospitalization rate per 100 person-years (4.5 [95% CI: 4.0-5.1]), paroxysmal AF (7.5 [95% CI: 6.4-8.7]), and persistent/permanent AF (6.4 [95% CI: 5.7-7.1]) (P $<$ 0.001). The benefit of dapagliflozin on the primary outcome was consistent across AF types: no AF, HR: 0.89 (95% CI: 0.74-1.08); paroxysmal AF, HR: 0.75 (95% CI: 0.58-0.97); persistent/permanent AF, HR: 0.79 (95% CI: 0.66-0.95) (Pinteraction = 0.49). Consistent effects were observed for HF hospitalization, cardiovascular death, all-cause mortality, and improvement in the KCCQ- TSS. CONCLUSIONS: In DELIVER, the beneficial effects of dapagliflozin compared with placebo on clinical events and symptoms were consistent, irrespective of type of AF at baseline. (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure. [DELIVER]; NCT03619213).
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| 18. |
- Butt, Jawad H., et al.
(author)
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Efficacy and Safety of Dapagliflozin According to Frailty in Patients With Heart Failure : A Prespecified Analysis of the DELIVER Trial.
- 2022
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In: Circulation. ; 146:16, s. 1210-1224
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Journal article (peer-reviewed)abstract
- BACKGROUND: Frailty is increasing in prevalence. Because patients with frailty are often perceived to have a less favorable risk/benefit profile, they may be less likely to receive new pharmacologic treatments. We investigated the efficacy and tolerability of dapagliflozin according to frailty status in patients with heart failure with mildly reduced or preserved ejection fraction randomized in DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure). METHODS: Frailty was measured using the Rockwood cumulative deficit approach. The primary end point was time to a first worsening heart failure event or cardiovascular death. RESULTS: Of the 6263 patients randomized, a frailty index (FI) was calculable in 6258. In total, 2354 (37.6%) patients had class 1 frailty (FI $<$/=0.210; ie, not frail), 2413 (38.6%) had class 2 frailty (FI 0.211-0.310; ie, more frail), and 1491 (23.8%) had class 3 frailty (FI $>$/=0.311; ie, most frail). Greater frailty was associated with a higher rate of the primary end point (per 100 person-years): FI class 1, 6.3 (95% CI 5.7-7.1); class 2, 8.3 (7.5-9.1); and class 3, 13.4 (12.1-14.7; P$<$0.001). The effect of dapagliflozin (as a hazard ratio) on the primary end point from FI class 1 to 3 was 0.85 (95% CI, 0.68-1.06), 0.89 (0.74-1.08), and 0.74 (0.61-0.91), respectively (Pinteraction=0.40). Although patients with a greater degree of frailty had worse Kansas City Cardiomyopathy Questionnaire scores at baseline, their improvement with dapagliflozin was greater than it was in patients with less frailty: placebo-corrected improvement in Kansas City Cardiomyopathy Questionnaire Overall Summary Score at 4 months in FI class 1 was 0.3 (95% CI, -0.9 to 1.4); in class 2, 1.5 (0.3-2.7); and in class 3, 3.4 (1.7-5.1; Pinteraction=0.021). Adverse reactions and treatment discontinuation, although more frequent in patients with a greater degree of frailty, were not more common with dapagliflozin than with placebo irrespective of frailty class. CONCLUSIONS: In DELIVER, frailty was common and associated with worse outcomes. The benefit of dapagliflozin was consistent across the range of frailty studied. The improvement in health-related quality of life with dapagliflozin occurred early and was greater in patients with a higher level of frailty. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03619213.
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| 19. |
- Cunningham, Jonathan W., et al.
(author)
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Dapagliflozin in Patients Recently Hospitalized With Heart Failure and Mildly Reduced or Preserved Ejection Fraction.
- 2022
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In: Journal of the American College of Cardiology. - : Elsevier BV. - 0735-1097. ; 80:14, s. 1302-1310
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Journal article (peer-reviewed)abstract
- BACKGROUND: Patients recently hospitalized for heart failure (HF) are at high risk for rehospitalization and death. OBJECTIVES: The purpose of this study was to investigate clinical outcomes and response to dapagliflozin in patients with HF with mildly reduced or preserved left ventricular ejection fraction (LVEF) who were enrolled during or following hospitalization. METHODS: The DELIVER (Dapagliflozin Evaluation to Improve the LIVES of Patients With PReserved Ejection Fraction Heart Failure) trial randomized patients with HF and LVEF $>$40% to dapagliflozin or placebo. DELIVER permitted randomization during or shortly after hospitalization for HF in clinically stable patients off intravenous HF therapies. This prespecified analysis investigated whether recent HF hospitalization modified risk of clinical events or response to dapagliflozin. The primary outcome was worsening HF event or cardiovascular death. RESULTS: Of 6,263 patients in DELIVER, 654 (10.4%) were randomized during HF hospitalization or within 30 days of discharge. Recent HF hospitalization was associated with greater risk of the primary outcome after multivariable adjustment (HR: 1.88; 95% CI: 1.60-2.21; P $<$ 0.001). Dapagliflozin reduced the primary outcome by 22% in recently hospitalized patients (HR: 0.78; 95% CI: 0.60-1.03) and 18% in patients without recent hospitalization (HR: 0.82; 95% CI: 0.72-0.94; Pinteraction = 0.71). Rates of adverse events, including volume depletion, diabetic ketoacidosis, or renal events, were similar with dapagliflozin and placebo in recently hospitalized patients. CONCLUSIONS: Dapagliflozin safely reduced risk of worsening HF or cardiovascular death similarly in patients with and without history of recent HF hospitalization. Starting dapagliflozin during or shortly after HF hospitalization in patients with mildly reduced or preserved LVEF appears safe and effective. (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure [DELIVER]; NCT03619213).
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| 20. |
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