Browsing by Subject "observational study"

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  • MASK Grp; Menditto, Enrica; Costa, Elisio; Midao, Luis; Haahtela, Tari; Toppila-Salmi, S.; Kuitunen, M.; Valovirta, E. (2019)
    Background: Mobile technology may help to better understand the adherence to treatment. MASK-rhinitis (Mobile Airways Sentinel NetworK for allergic rhinitis) is a patient-centred ICT system. A mobile phone app (the Allergy Diary) central to MASK is available in 22 countries. Objectives: To assess the adherence to treatment in allergic rhinitis patients using the Allergy Diary App. Methods: An observational cross-sectional study was carried out on all users who filled in the Allergy Diary from 1 January 2016 to 1 August 2017. Secondary adherence was assessed by using the modified Medication Possession Ratio (MPR) and the Proportion of days covered (PDC) approach. Results: A total of 12143 users were registered. A total of 6949 users reported at least one VAS data recording. Among them, 1887 users reported >= 7 VAS data. About 1195 subjects were included in the analysis of adherence. One hundred and thirty-six (11.28%) users were adherent (MPR >= 70% and PDC = 70% and PDC = 1.50) and 176 (14.60%) were switchers. On the other hand, 832 (69.05%) users were non-adherent to medications (MPR Conclusion and clinical relevance: Adherence to treatment is low. The relative efficacy of continuous vs on-demand treatment for allergic rhinitis symptoms is still a matter of debate. This study shows an approach for measuring retrospective adherence based on a mobile app. This also represents a novel approach for analysing medication-taking behaviour in a real-world setting.
  • Tiškina, Valentina; Lindqvist, E.-L.; Blomqvist, A.-C.; Orav, Merle; Stensvold, C.R.; Jokelainen, P. (2019)
    Angiostrongylus vasorum has spread farther north in Europe. In this study, two autochthonous findings from dogs from Finland are described: In February 2014, the infection was diagnosed in a 10-month-old labrador retriever, and in February 2017, in a three-year-old French bulldog. These diagnoses were based on direct detection of the larvae from faeces of the dogs. The dogs had no history of travel to or import from abroad; the first lived in Southern Finland and the other in Western Finland, about 150 km apart. The dogs had no clinical signs attributable to angiostrongylosis. An online questionnaire was used to survey the extent to which veterinarians in Finland have self-reportedly observed canine A vasorum infections. A total of 38 veterinarians authorised to work in Finland answered the questionnaire in December 2017, and 9 (24%) of them reported having seen one or more dogs with A vasorum infection in Finland. The results suggest that at least five individual dogs with A vasorum infection would have been seen in Finland, three of which had an apparently autochthonous infection. While the geographical distribution of A vasorum in Finland remains largely unknown, findings have started to appear from domestic dogs. It remains possible that some veterinarians could have misdiagnosed, for example, Crenosoma vulpis larvae as those of A vasorum, and the findings without confirmation using antigen test could be due to coprophagy and passage of ingested larvae; however, this does not change the main conclusion that can be made: A vasorum is already multifocally present in Finland. Increasing awareness about A vasorum is important in areas where it is emerging and spreading. © 2019 British Veterinary Association.
  • SICS Study Grp; Hiemstra, Bart; Eck, Ruben J.; Wiersema, Renske; Pettilä, Ville; van der Horst, Iwan C. C. (2019)
    Objectives: Caregivers use clinical examination to timely recognize deterioration of a patient, yet data on the prognostic value of clinical examination are inconsistent. In the Simple Intensive Care Studies-I, we evaluated the association of clinical examination findings with 90-day mortality in critically ill patients. Design: Prospective single-center cohort study. Setting: ICU of a single tertiary care level hospital between March 27, 2015, and July 22, 2017. Patients: All consecutive adults acutely admitted to the ICU and expected to stay for at least 24 hours. Interventions: A protocolized clinical examination of 19 clinical signs conducted within 24 hours of admission. Measurements Main Results: Independent predictors of 90-day mortality were identified using multivariable logistic regression analyses. Model performance was compared with established prognostic risk scores using area under the receiver operating characteristic curves. Robustness of our findings was tested by internal bootstrap validation and adjustment of the threshold for statistical significance. A total of 1,075 patients were included, of whom 298 patients (28%) had died at 90-day follow-up. Multivariable analyses adjusted for age and norepinephrine infusion rate demonstrated that the combination of higher respiratory rate, higher systolic blood pressure, lower central temperature, altered consciousness, and decreased urine output was independently associated with 90-day mortality (area under the receiver operating characteristic curves = 0.74; 95% CI, 0.71-0.78). Clinical examination had a similar discriminative value as compared with the Simplified Acute Physiology Score-II (area under the receiver operating characteristic curves = 0.76; 95% CI, 0.73-0.79; p = 0.29) and Acute Physiology and Chronic Health Evaluation-IV (using area under the receiver operating characteristic curves = 0.77; 95% CI, 0.74-0.80; p = 0.16) and was significantly better than the Sequential Organ Failure Assessment (using area under the receiver operating characteristic curves = 0.67; 95% CI, 0.64-0.71; p <0.001). Conclusions: Clinical examination has reasonable discriminative value for assessing 90-day mortality in acutely admitted ICU patients. In our study population, a single, protocolized clinical examination had similar prognostic abilities compared with the Simplified Acute Physiology Score-II and Acute Physiology and Chronic Health Evaluation-IV and outperformed the Sequential Organ Failure Assessment score.
  • Mäkelä, Mika J.; Christensen, Helene Nordahl; Karlsson, Antti; Rastogi, Sarang; Kettunen, Kirsi (2018)
    Background: Eosinophilic airway inflammation is common in asthma patients and appears to be associated with severe exacerbations and loss of asthma control. Objective: To describe the resource utilization and clinical characteristics of patients with eosinophilic asthma. Design: Asthma patients >= 18 years with >= 1 blood eosinophil count in secondary care (South West Finland) during 2003. 2013 were included. Clinical characteristics (age, lung function, body mass index, and comorbidities) and asthma-related resource utilization (hospital admissions, outpatient visits, and emergency room [ER] visits) were retrieved. Resource utilization rates were compared for patients with blood eosinophil 300 cells/mu L, using adjusted negative binomial regression models. Results: Overall, 4,357 eligible patients were identified (mean age 60 years, females 68%), of which 1,927 (44%) had > 300 eosinophil cells/mu L blood. Patients with 300 eosinophil counts, exhibited similar clinical characteristics, including advanced age, poor lung function, and overweight. Comorbidities such as pneumonia, sinusitis, and nasal polyps, were more frequent among those with > 300 eosinophil cells/mu L blood compared with patients with lower counts. Eosinophil counts > 300 cells/mu L were associated with greater hospital admissions (rate ratio [RR] [95% confidence interval CI]: 1.13 [1.02; 1.24]) and outpatient visits (RR [95% CI]: 1.11 [1.03; 1.20]) compared with patients with lower eosinophil counts. Rates of ER visits were similar between the patient groups (RR [95% CI]: 0.99 [0.87; 1.12]). Conclusions: Hospital admissions and outpatient visits occurred more often for patients with eosinophil counts > 300 cells/mu L, than for patients with lower eosinophil counts. Routine blood eosinophil screening might be useful to identify patients with an eosinophilic phenotype eligible for more targeted treatments.
  • Renlund, Michelle; Böckelman, Camilla; Victorzon, Mikael (Helsingin yliopisto, 2018)
    Abstract Background and aims: Diagnosis based solely on symptoms may lead to a high negative appendectomy rate and unnecessary surgery. We investigated the outcomes of appendectomies and determined if changes in the diagnostic work-up routines of acute appendicitis are necessary. Material and methods: We conducted a retrospective analysis of all emergency appendectomies performed in our hospital during a five-year period (2010–2014). We included a total of 805 consecutive patients undergoing open or laparoscopic appendectomy. Elective appendectomies (n=13) were excluded. Outcomes were compared by the chi-square and Mann-Whitney U tests. Results: Out of 805 patients, 345 (42.9%) were operated on by a laparoscopic approach; the laparoscopic technique was increasingly used during the study years. Women underwent laparoscopic appendectomy (58.6%) more often than men (29.8%; p<0.001). The mean operating time was marginally shorter with the open approach (55 versus 58 min; p=0.027). Postoperative hospital stay was shorter for the laparoscopic group (1.8 versus 2.3 days; p=0.014). The negative appendectomy rate was 7.8%. Conclusion: The negative appendectomy rate in this cohort of consecutive emergency appendectomies without systematic diagnostic imaging was low. Keywords: Appendicitis, appendectomy, appendectomy rate, laparoscopic approach, open approach, observational study
  • Kraus, W.E.; Yates, T.; Tuomilehto, J.; Sun, J.-L.; Thomas, L.; Mcmurray, J.J.V.; Bethel, M.A.; Holman, R.R. (2018)
    Objective: Physical activity is related to clinical outcomes, even after adjusting for body mass, but is rarely assessed in randomized clinical trials. Research design and methods: We conducted an observational analysis of data from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research trial, in which a total of 9306 people from 40 countries with impaired glucose tolerance and either cardiovascular disease or cardiovascular risk factors were randomized to receive nateglinide or placebo, in a 2-by-2 factorial design with valsartan or placebo. All were asked to also participate in a detailed lifestyle modification programme and followed-up for a median of 6.4 years with progression to diabetes as a co-primary end point. Seven-day ambulatory activity was assessed at baseline using research-grade pedometers. We assessed whether the baseline amount of physical activity was related to subsequent development of diabetes in individuals with impaired glucose tolerance. Results: Pedometer data were obtained on 7118 participants and 35.0% developed diabetes. In an unadjusted analysis each 2000-step increment in the average number of daily steps, up to 10 000, was associated with a 5.5% lower risk of progression to diabetes (HR 0.95, 95%CI 0.92 to 0.97), with >6% relative risk reduction after adjustment. Conclusions: Physical activity should be measured objectively in pharmacologic trials as it is a significant but underappreciated contributor to diabetes outcomes. It should be a regular part of clinical practice as well. © 2018 Author(s) (or their employer(s).
  • Ljungman, Lisa; Anandavadivelan, Poorna; Jahnukainen, Kirsi; Lampic, Claudia; Wettergren, Lena (2020)
    Background: This study protocol describes the Fex-Can Childhood project, comprising two studies: The Fex-Can Childhood observational study (OS) and the Fex-Can Childhood randomized controlled trial (RCT). The Fex-Can Childhood OS aims to determine the prevalence and predictors of sexual dysfunction and fertility-related distress in young adult childhood cancer survivors (aged 19-40) compared to an age matched comparison group; the Fex-Can Childhood RCT will evaluate the effect of a web-based psycho-educational intervention (Fex-Can intervention) on sexual dysfunction and fertility-related distress. Methods: The Fex-Can Childhood OS will have a population-based cross-sectional design. All individuals treated for childhood cancer in Sweden at the age of 0 to 17 years (current age 19-40) will be identified through the National Quality Registry for Childhood Cancer. Established self-reported instruments will be used to measure sexual function, fertility-related distress, body image, anxiety and depression, and health-related quality of life. Self-efficacy related to sexual function and fertility, and fertility-related knowledge, will be assessed by study-specific measures. Clinical variables will be collected from the registry. Results will be compared to an age-matched comparison group from the general population. Participants in the Fex-Can Childhood OS who report a high level of sexual dysfunction and/or fertility-related distress will be invited to participate in the RCT. The Fex-Can intervention comprises two programs: The Fex-Can Sex and the Fex-Can Fertility targeting sexual dysfunction and fertility-related distress, respectively. The control condition will be a wait-list. Sexual function and fertility-related distress will be the primary outcomes. The secondary outcomes include body image, anxiety and depression, health-related quality of life and self-efficacy related to sexual function and fertility. Post- and follow-up assessments will be conducted directly after end of intervention (primary end point), at 3 months and 6 months after end of intervention. Additionally, a process-evaluation including study-specific items and a qualitative interview will be conducted. Discussion: The Fex-Can Childhood project will advance knowledge in the areas of sexual function and fertility-related distress among young adult survivors of childhood cancer. If the Fex-Can intervention proves to be efficacious, steps will be taken to implement it in the follow-up care provided to this population.
  • Bousquet, J.; Devillier, P.; Arnavielhe, S.; Bedbrook, A.; Alexis-Alexandre, G.; van Eerd, M.; Murray, R.; Canonica, G. W.; Illario, M.; Menditto, E.; Passalacqua, G.; Stellato, C.; Triggiani, M.; Carreiro-Martins, P.; Fonseca, J.; Morais Almeida, M.; Nogueira-Silva, L.; Pereira, A. M.; Todo Bom, A.; Bosse, I.; Caimmi, D.; Demoly, P.; Fontaine, J. F.; Just, J.; Onorato, G. L.; Kowalski, M. L.; Kuna, P.; Samolinski, B.; Anto, J. M.; Mullol, J.; Valero, A.; Tomazic, P. V.; Bergmann, K. C.; Keil, T.; Klimek, L.; Moesges, R.; Shamai, S.; Zuberbier, T.; Murphy, E.; McDowall, P.; Price, D.; Ryan, D.; Sheikh, A.; Chavannes, N. H.; Fokkens, W. J.; Kvedariene, V.; Valiulis, A.; Bachert, C.; Hellings, P. W.; Kull, I.; Melen, E.; Wickman, M.; Bindslev-Jensen, C.; Eller, E.; Haahtela, T.; Papadopoulos, N. G.; Annesi-Maesano, I.; Bewick, M.; Bosnic-Anticevich, S.; Cruz, A. A.; De Vries, G.; Gemicioglu, B.; Larenas-Linnemann, D.; Laune, D.; Mathieu-Dupas, E.; O'Hehir, R. E.; Pfaar, O.; Portejoie, F.; Siroux, V.; Spranger, O.; Valovirta, E.; VandenPlas, O.; Yorgancioglu, A. (2018)
    BackgroundLarge observational implementation studies are needed to triangulate the findings from randomized control trials as they reflect real-world everyday practice. In a pilot study, we attempted to provide additional and complementary insights on the real-life treatment of allergic rhinitis (AR) using mobile technology. MethodsA mobile phone app (Allergy Diary, freely available in Google Play and Apple App stores) collects the data of daily visual analog scales (VAS) for (i) overall allergic symptoms, (ii) nasal, ocular, and asthma symptoms, (iii) work, as well as (iv) medication use using a treatment scroll list including all medications (prescribed and over the counter (OTC)) for rhinitis customized for 15 countries. ResultsA total of 2871 users filled in 17 091 days of VAS in 2015 and 2016. Medications were reported for 9634 days. The assessment of days appeared to be more informative than the course of the treatment as, in real life, patients do not necessarily use treatment on a daily basis; rather, they appear to increase treatment use with the loss of symptom control. The Allergy Diary allowed differentiation between treatments within or between classes (intranasal corticosteroid use containing medications and oral H1-antihistamines). The control of days differed between no [best control], single, or multiple treatments (worst control). ConclusionsThis study confirms the usefulness of the Allergy Diary in accessing and assessing everyday use and practice in AR. This pilot observational study uses a very simple assessment (VAS) on a mobile phone, shows novel findings, and generates new hypotheses.