Browsing by Subject "randomized trial"

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  • Hemilä, Harri; Chalker, Elizabeth (2021)
    In this individual patient data meta-analysis we examined datasets of two randomized placebo-controlled trials which investigated the effect of nasal carrageenan separately on children and adults. In both trials, iota-carrageenan was administered nasally three times per day for 7 days for patients with the common cold and follow-up lasted for 21 days. We used Cox regression to estimate the effect of carrageenan on recovery rate. We also used quantile regression to calculate the effect of carrageenan on colds of differing lengths. Nasal carrageenan increased the recovery rate from all colds by 54% (95% CI 15%-105%; p = .003). The increase in recovery rate was 139% for coronavirus infections, 119% for influenza A infections, and 70% for rhinovirus infections. The mean duration of all colds in the placebo groups of the first four quintiles were 4.0, 6.8, 8.8, and 13.7 days, respectively. The fifth quintile contained patients with censored data. The 13.7-day colds were shortened by 3.8 days (28% reduction), and 8.8-day colds by 1.3 days (15% reduction). Carrageenan had no meaningful effect on shorter colds. In the placebo group, 21 patients had colds lasting over 20 days, compared with six patients in the carrageenan group, which corresponds to a 71% (p = .003) reduction in the risk of longer colds. Given that carrageenan has an effect on diverse virus groups, and effects at the clinical level on two old coronaviruses, it seems plausible that carrageenan may have an effect on COVID-19. Further research on nasal iota-carrageenan is warranted.
  • NAVIGATE ESUS Steering Comm (2018)
    Background: The New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial vs. ASA to Prevent Embolism in Embolic Stroke of Undetermined Source (NAVIGATE-ESUS) trial is a randomized phase-III trial comparing rivaroxaban versus aspirin in patients with recent ESUS. Aims: We aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups. Methods: We enrolled 7213 patients at 459 sites in 31 countries. Prespecified subgroups for primary safety and efficacy analyses included age, sex, race, global region, stroke or transient ischemic attack prior to qualifying event, time to randomization, hypertension, and diabetes mellitus. Results: Mean age was 66.9 +/- 9.8 years; 24% were under 60 years. Older patients had more hypertension, coronary disease, and cancer. Strokes in older subjects were more frequently cortical and accompanied by radiographic evidence of prior infarction. Women comprised 38% of participants and were older than men. Patients from East Asia were oldest whereas those from Latin America were youngest. Patients in the Americas more frequently were on aspirin prior to the qualifying stroke. Acute cortical infarction was more common in the United States, Canada, and Western Europe, whereas prior radiographic infarctions were most common in East Asia. Approximately forty-five percent of subjects were enrolled within 30 days of the qualifying stroke, with earliest enrollments in Asia and Eastern Europe. Conclusions: NAVIGATE-ESUS is the largest randomized trial comparing antithrombotic strategies for secondary stroke prevention in patients with ESUS. The study population encompasses a broad array of patients across multiple continents and these subgroups provide ample opportunities for future research.
  • Rissanen, Julius (Helsingin yliopisto, 2021)
    Abstract Faculty: Faculty of Social Sciences Program: Economics Study track: General Track Author: Julius Vili Henrik Rissanen Title: Comparing cost-effectiveness of short-term and long-term psychodynamic psychotherapies focusing on patients with depressive disorder and their work ability during a 5-year follow-up. Level: Master’s Thesis Month and Year: November 2021 Number of Pages: Keywords: Psychotherapy; cost-effectiveness; Work Ability; psychodynamic; randomized trial; Instructors: Roope Uusitalo, Lauri Sääksvuori, Costanza Biavaschi, Olavi Lindfors Deposited at: Helsingin Yliopiston kirjasto Other information: Abstract: Background: Mental health disorders pose significant burden to the society, for example, because of decreased work ability. Psychotherapy as one of the most important treatment methods also causes significant costs for the healthcare system. Putting effort into cost-effectiveness between the different therapy types can help promote better targeting of treatments and economic efficiency in society. Aims: Explore cost-effectiveness in improving work ability between short-term and long-term psychodynamic psychotherapy in patients with depression. Methods: The 192 depressive patients randomized to two psychotherapies of different lengths in the Helsinki Psychotherapy Study were measured in baseline and annually for five years. Work Ability Index (WAI) and Global Assessment of Functioning (GAF) as an effectiveness outcome measures were compared to the total direct costs with incremental cost-effectiveness ratios (ICER) between the treatments. Results: The total direct cost of short-term psychodynamic psychotherapy (SPP; €7,087) was significantly lower than for long-term psychodynamic psychotherapy (LPP; €19,959). The biggest explanatory factor between the cost of the treatments was protocol study therapy costs (SPP €1304; LPP €16,715). In addition, those randomized to the SPP had significant costs during the follow-up from the non-protocol auxiliary psychotherapy treatments (€5142) which were more than fives times compared to the LPP. All of these cost differences between the treatment groups were statistically significant. Psychotropic medication and outpatient care each averaged below €2000, and the differences weren’t statistically significant. Psychiatric hospitalization during the follow-up was rare but yielded significant costs to the associated patients. Differences of effectiveness between the treatment groups on the work ability were not statistically significant. The incremental cost-effectiveness ratio was highly unstable due to small differences in efficiency, but large differences in cost. Conclusions: The study found a clear difference in cost in favour of SPP without losing in the effectiveness of the treatment. However, patients in the SPP used a significant amount of non-protocol auxiliary psychotherapy treatments which may be an indication of insufficient therapy treatment. The absence of difference in the effectiveness can be thus attributed to the widespread utilization of additional treatments in the SPP. Going forward, expanding the study to account for the impact of patient’s suitability to the treatment, particularly in understanding SPP cost-effectiveness, would be worthwhile.
  • Chan, Juliana C. N.; Paldanius, Päivi M.; Mathieu, Chantal; Stumvoll, Michael; Matthews, David R.; Del Prato, Stefano (2021)
    We analysed glycaemic durability (sustained glycaemic control) with early combination therapy (metformin plus vildagliptin) versus metformin monotherapy, among patients with type 2 diabetes diagnosed before (young-onset [YOD]) and after (late-onset [LOD]) the age of 40 years, enrolled in the VERIFY trial. The primary endpoint was time to initial treatment failure (TF), defined as HbA1c of 7.0% or higher at two consecutive scheduled visits after randomization. The time to secondary TF was assessed when both groups were receiving and failing on the combination. A total of 186 (9.3%) patients had YOD and 1815 (90.7%) had LOD with a mean age difference of 20.4 years. Compared with metformin monotherapy, early combination reduced the risk of time to initial TF for both YOD (48%,P<.0006) and LOD (46%,P<.0001). With early combination, risk for time to secondary TF was reduced by 48% (P<.0035) in YOD and 24% (P<.0009) in LOD. Both treatment approaches were well tolerated with no unexpected safety concerns. In treatment-naive patients with YOD (HbA1c 6.5%-7.5%), an early combination strategy improved attainment of the glycaemic target with durability and delayed treatment escalation compared with initial metformin monotherapy.
  • Campbell, Bruce C. V.; Mitchell, Peter J.; Churilov, Leonid; Keshtkaran, Mahsa; Hong, Keun-Sik; Kleinig, Timothy J.; Dewey, Helen M.; Yassi, Nawaf; Yan, Bernard; Dowling, Richard J.; Parsons, Mark W.; Wu, Teddy Y.; Brooks, Mark; Simpson, Marion A.; Miteff, Ferdinand; Levi, Christopher R.; Krause, Martin; Harrington, Timothy J.; Faulder, Kenneth C.; Steinfort, Brendan S.; Ang, Timothy; Scroop, Rebecca; Barber, P. Alan; McGuinness, Ben; Wijeratne, Tissa; Phan, Thanh G.; Chong, Winston; Chandra, Ronil V.; Bladin, Christopher F.; Rice, Henry; de Villiers, Laetitia; Ma, Henry; Desmond, Patricia M.; Meretoja, Atte; Cadilhac, Dominique A.; Donnan, Geoffrey A.; Davis, Stephen M.; EXTEND-IA Investigators (2017)
    Background: Endovascular thrombectomy improves functional outcome in large vessel occlusion ischemic stroke. We examined disability, quality of life, survival and acute care costs in the EXTEND-IA trial, which used CT-perfusion imaging selection. Methods: Large vessel ischemic stroke patients with favorable CT-perfusion were randomized to endovascular thrombectomy after alteplase versus alteplase-only. Clinical outcome was prospectively measured using 90-day modified Rankin scale (mRS). Individual patient expected survival and net difference in Disability/Quality-adjusted life years (DALY/QALY) up to 15 years from stroke were modeled using age, sex, 90-day mRS, and utility scores. Level of care within the first 90 days was prospectively measured and used to estimate procedure and inpatient care costs (US$ reference year 2014). Results: There were 70 patients, 35 in each arm, mean age 69, median NIHSS 15 (IQR 12-19). The median (IQR) disability-weighted utility score at 90 days was 0.65 (0.00-0.91) in the alteplase-only versus 0.91 (0.65-1.00) in the endovascular group (p = 0.005). Modeled life expectancy was greater in the endovascular versus alteplaseonly group (median 15.6 versus 11.2 years, p = 0.02). The endovascular thrombectomy group had fewer simulated DALYs lost over 15 years [median (IQR) 5.5 (3.2-8.7) versus 8.9 (4.7-13.8), p = 0.02] and more QALY gained [median (IQR) 9.3 (4.2-13.1) versus 4.9 (0.3-8.5), p = 0.03]. Endovascular patients spent less time in hospital [median (IQR) 5 (3-11) days versus 8 (5-14) days, p = 0.04] and rehabilitation [median (IQR) 0 (0-28) versus 27 (0-65) days, p = 0.03]. The estimated inpatient costs in the first 90 days were less in the thrombectomy group (average US$15,689 versus US$30,569, p = 0.008) offsetting the costs of interhospital transport and the thrombectomy procedure (average US$10,515). The average saving per patient treated with thrombectomy was US$4,365. c Conclusion: Thrombectomy patients with large vessel occlusion and salvageable tissue on CT-perfusion had reduced length of stay and overall costs to 90 days. There was evidence of clinically relevant improvement in long-term survival and quality of life.
  • Gray, Penelope; Palmroth, Johanna; Luostarinen, Tapio; Apter, Dan; Dubin, Gary; Garnett, Geoff; Eriksson, Tiina; Natunen, Kari; Merikukka, Marko; Pimenoff, Ville; Soderlund-Strand, Anna; Vanska, Simopekka; Paavonen, Jorma; Pukkala, Eero; Dillner, Joakim; Lehtinen, Matti (2018)
    Efficacy of human papillomavirus (HPV) vaccines promises to control HPV infections. However, HPV vaccination programs may lay bare an ecological niche for non-vaccine HPV types. We evaluated type-replacement by HPV type and vaccination strategy in a community-randomized trial executed in HPV vaccination naive population. Thirty-three communities were randomized to gender-neutral vaccination with AS04-adjuvanted HPV16/18 vaccine (Arm A), HPV vaccination of girls and hepatitis B-virus (HBV) vaccination of boys (Arm B) and gender-neutral HBV vaccination (Arm C). Resident 1992-95 born boys (40,852) and girls (39,420) were invited. 11,662 boys and 20,513 girls were vaccinated with 20-30% and 45-48% coverage, respectively. HPV typing of 11,396 cervicovaginal samples was performed by high throughput PCR. Prevalence ratios (PR) between arms and ranked order of HPV types and odds ratio (OR) for having multiple HPV types in HPV16 or 18/45 positive individuals were calculated. The ranked order of HPV types did not significantly differ between arms or birth cohorts. For the non-HPV vaccinated 1992-1993 birth cohorts increased PR, between the gender-neutral intervention versus control arms for HPV39 (PRA 1.84, 95% CI 1.12-3.02) and HPV51 (PRA 1.56, 95% CI 1.11-2.19) were observed. In the gender-neutral arm, increased clustering between HPV39 and the vaccine-covered HPV types 16 or 18/45 (ORA16 = 5.1, ORA18/45 = 11.4) was observed in the non-HPV vaccinated 1994-1995 birth cohorts. Comparable clustering was seen between HPV51 and HPV16 or HPV18/45 (ORB16 = 4.7, ORB18/45 = 4.3), in the girls-only arm. In conclusion, definitively consistent postvaccination patterns of HPV type-replacement were not observed. Future occurrence of HPV39 and HPV51 warrant investigation.
  • Matthews, David R.; Del Prato, Stefano; Mohan, Viswanathan; Mathieu, Chantal; Vencio, Sergio; Chan, Juliana C. N.; Stumvoll, Michael; Paldanius, Päivi M. (2020)