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  • 1.
    Heddini, Andreas
    et al.
    GSK Nordic Cluster, GSK, Solna, Sweden.
    Sundh, Josefin
    Örebro University, School of Medical Sciences. Department of Respiratory Medicine.
    Ekström, Magnus
    Department of Clinical Sciences Lund, Respiratory Medicine and Allergology, Lund University, Lund, Sweden.
    Janson, Christer
    Department of Medical Sciences: Respiratory, Allergy & Sleep Research, Uppsala University, Uppsala, Sweden.
    Effectiveness trials: critical data to help understand how respiratory medicines really work?2019In: European Clinical Respiratory Journal, ISSN 2001-8525, Vol. 6, no 1, article id 1565804Article, review/survey (Refereed)
    Abstract [en]

    Most of the information about the benefits, safety aspects, and cost effectiveness of pharmacological treatment in the respiratory field has been obtained from traditional efficacy studies, such as randomised controlled trials (RCT). The highly controlled environment of an RCT does not always reflect everyday practice. The collection, analysis, and application of effectiveness data to generate Real World Evidence (RWE) through pragmatic trials or observational studies therefore has the potential to improve decision making by regulators, payers, and clinicians. Despite calls for more RWE, effectiveness data are not widely used in decision making in the respiratory field. Recent advances in data capture, curation, and storage combined with new analytical tools have now made it feasible for effectiveness data to become routine sources of evidence to supplement traditional efficacy data. In this paper, we will examine some of the current data gaps, diverse types of effectiveness data, look at proposed frameworks for the positioning of effectiveness data, as well as provide examples from therapeutic areas. We will give examples of both previous effectiveness studies and studies that are ongoing within the respiratory field. Effectiveness data hold the potential to address several evidentiary gaps related to the effectiveness, safety, and value of treatments in patients with respiratory diseases.

  • 2.
    Kämpe, Mary
    et al.
    Department of Medical Sciences, Respiratory Medicine and Allergology, Uppsala University, Uppsala, Sweden.
    Lisspers, Karin
    Department of Public Health and Caring Science, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.
    Ställberg, Björn
    Department of Public Health and Caring Science, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.
    Sundh, Josefin
    Örebro University, School of Medicine, Örebro University, Sweden. Örebro University Hospital. Deparment of Respiratory Medicine, Örebro University Hospital, Örebro, Sweden.
    Montgomery, Scott
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Örebro University Hospital. Clinical Epidemiology Unit, Department of Medicine, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden; Department of Epidemiology and Public Health, University College London, London, UK.
    Jansson, Christer
    Department of Medical Sciences, Respiratory Medicine and Allergology, Uppsala University, Uppsala, Sweden.
    Determinants of uncontrolled asthma in a Swedish asthma population: cross-sectional observational study2014In: European Clinical Respiratory Journal, ISSN 2001-8525, Vol. 1, article id 24109Article in journal (Refereed)
    Abstract [en]

    Background: Asthma control is achieved in a low proportion of patients. The primary aim was to evaluate risk factors for uncontrolled asthma. The secondary aim was to assess quality of life associated with asthma control.

    Methods: In a cross-sectional study, asthma patients aged 18–75 were randomly selected from primary and secondary health care centers. Postal questionnaires were sent to 1,675 patients and the response rate was 71%. A total of 846 patients from primary and 341 patients from secondary care were evaluated. Data were collected using a questionnaire and review of medical records. The questionnaire included questions about asthma control and a quality-of-life questionnaire, the mini-AQLQ, with four domains (symptoms, activity limitation, emotional function, and environmental stimuli). The mean score for each domain and the overall score were calculated. Asthma control was divided into three levels according to the GINA guidelines and partly and uncontrolled asthma were combined into one group – poorly controlled asthma.

    Results: Asthma control was achieved in 36% of the sample: 38% in primary and 29% in secondary care. In primary and secondary care, 35 and 45% had uncontrolled asthma, respectively. Risk factors for poorly controlled asthma were female sex [OR 1.31 (1.003–1.70)], older age [OR 2.18 (1.28–3.73)], lower educational level [OR 1.63 (1.14–2.33)], and current smoking [OR 1.68 (1.16–2.43)]. Older age and lower educational level remained statistically significantly associated with poorly controlled asthma when the analyses were limited to never-smokers. Depression was an independent risk factor for poorly controlled asthma in men [OR 3.44 (1.12–10.54)]. The mini-AQLQ scores and the mean overall score were significantly lower in uncontrolled asthma.

    Conclusion: Risk factors for poorly controlled asthma were female sex, older age, low educational level, and smoking. Uncontrolled asthma was significantly associated with lower quality of life.

  • 3.
    Stegberg, Marcus
    et al.
    School of Medical Sciences, Örebro University, Örebro, Sweden.
    Hasselgren, Mikael
    Örebro University, School of Medical Sciences.
    Montgomery, Scott
    Örebro University, School of Medical Sciences. Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Department of Epidemiology and Public Health, University College, London, UK .
    Lisspers, Karin
    Department of Public Health and Caring Sciences, Family Medicine and Preventive medicine, Uppsala University, Uppsala, Sweden.
    Ställberg, Björn
    Department of Public Health and Caring Sciences, Family Medicine and Preventive medicine, Uppsala University, Uppsala, Sweden.
    Janson, Christer
    Department of Medical Sciences, Respiratory, Allergy & Sleep Research, Uppsala University, Uppsala, Sweden.
    Sundh, Josefin
    Örebro University, School of Medical Sciences. Department of Respiratory Medicine, Faculty of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Changes in smoking prevalence and cessation support, and factors associated with successful smoking cessation in Swedish patients with asthma and COPD2018In: European Clinical Respiratory Journal, ISSN 2001-8525, Vol. 5, article id 1421389Article in journal (Refereed)
    Abstract [en]

    Introduction: Our aim was to investigate changes in smoking prevalence, smoking cessation support and factors associated with successful smoking cessation in patients with asthma and COPD.

    Methods: Questionnaires about available smoking cessation resources were completed by 54 primary health-care centers and 14 hospitals in central Sweden in 2005 and 2012. Patient data were collected using record reviews and patients questionnaires for two cohorts of randomly selected asthma and COPD patients in 2005 (n = 2306; with a follow up in 2012), and in 2014/ 2015 (n = 2620). Smoking prevalence, available individual and group smoking cessation support, and factors associated with successful smoking cessation were explored.

    Results: Smoking prevalence decreased from 11% to 6% (p < 0.0001) in patients with asthma but was almost unchanged in patients with COPD (28 to 26%, p = 0.37). Smoking cessation support increased from 53% to 74% (p = 0.01). A high cardiovascular risk factor level, including diabetes mellitus and hypertension was associated with improved smoking cessation in patients with asthma (OR (95% CI) 3.87 (1.04-14.4), p = 0.04). A higher magnitude success was observed in men with asthma (OR (95% CI) 27.9 (1.73-449), p = 0.02). More highly educated women with asthma had successful greater smoking cessation (4.76 (1.22-18.7), p = 0.04). No significant associations were found in COPD.

    Conclusions: The smoking prevalence in patients with asthma but not in COPD has almost halved in Sweden during a 7-year period. The availability of smoking cessation support has increased. Suggested factors related to successful smoking cessation are higher level of education in women with asthma and cardiovascular risk factors in men and women with asthma.

  • 4.
    Sundh, Josefin
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Respiratory Medicine, Örebro University Hospital, Örebro, Sweden.
    Janson, Christer
    Department of Medical Sciences: Respiratory; Allergy and Sleep Research, Uppsala University, Uppsala, Sweden.
    Johansson, Gunnar
    Department of Public Health and Caring Science, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.
    Lindén, Anders
    Unit for Lung and Airway Research, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
    Löfdahl, Claes-Goran
    Department of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.
    Sandström, Thomas
    Department of Public Health and Clinical Medicine, Division of Medicine, Umeå University, Umeå, Sweden.
    Larsson, Kjell
    Unit for Lung and Airway Research, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
    Characterization of secondary care for COPD in Sweden2017In: European Clinical Respiratory Journal, ISSN 2001-8525, Vol. 4, p. 1-8Article in journal (Refereed)
    Abstract [en]

    Introduction: Only a selected proportion of chronic obstructive pulmonary disease (COPD) patients are managed in secondary care. The aim of this study was to characterize disease severity, treatment and structure of secondary care for COPD in Sweden.

    Methods: Information was collected from 29 of 33 existing secondary care units of respiratory medicine in Sweden, using both individual data from 373 consecutively enrolled COPD patients with Global initiative on Obstructive Lung Disease (GOLD) stage III-IV and a structural questionnaire about available resources at the units. Patient data included exacerbations, health status assessed by COPD Assessment Test (CAT), lung function, comorbid conditions, pharmacological treatment and vaccinations. Structural data included available smoking cessation support, multi-disciplinary rehabilitation, physical training, patient education and routine follow-up after exacerbations at the respective unit. All patients were reclassified according to the GOLD 2014 group AD classification. Multiple linear regression investigated associations of available resources with number of exacerbations and CAT score.

    Results: According to GOLD 2014, 87% of the population were GOLD D and 13% were GOLD C. Triple inhaled therapy were prescribed in 88% of the patients. Over 75% of the units had resources for smoking cessation, multidisciplinary rehabilitation, physical training and patient education. Routine follow-up after exacerbations was available in 35% of the units. Being managed at units with access to structured patient education was associated with statistically significantly fewer exacerbations (adjusted regression coefficient (95% confidence interval) -0.79 (-1.39 to -0.19), p = 0.010).

    Conclusion: Most stage III-IV COPD patients managed at secondary care respiratory units in Sweden have maximized inhaled therapy and high risk disease even when reclassified according to GOLD 2014. Most units have access to smoking cessation, rehabilitation and patient education. Patients managed at units with structured patient education have a lower exacerbation risk.

  • 5.
    Sundh, Josefin
    et al.
    Örebro University, School of Medical Sciences.
    Åberg, Joakim
    School of Medical Sciences, Örebro University, Örebro, Sweden.
    Hasselgren, Mikael
    Örebro University, School of Medical Sciences.
    Montgomery, Scott
    Örebro University, School of Medical Sciences. Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Department of Epidemiology and Public Health, University College London, London, UK.
    Ställberg, Björn
    Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.
    Lisspers, Karin
    Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.
    Janson, Christer
    Department of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden.
    Factors influencing pharmacological treatment in COPD: a comparison of 2005 and 20142017In: European Clinical Respiratory Journal, ISSN 2001-8525, Vol. 4, article id 1409060Article in journal (Refereed)
    Abstract [en]

    Introduction: The aim was to investigate how the pattern of pharmacological treatment in Swedish patients with chronic obstructive pulmonary disease (COPD) has changed over a decade, and to identify factors associated with treatment.

    Methods: Data on patient characteristics and pharmacological treatment were collected using questionnaires from two separate cohorts of randomly selected primary and secondary care patients with a doctor's diagnosis of COPD in central Sweden, in 2005 (n = 1111) and 2014 (n = 1329). Cross-tabulations and chi-square tests were used to compare maintenance treatment in 2005 and 2014, and to investigate the distribution of treatment by the 2017 Global Initiative for Obstructive Lung Disease (GOLD) ABCD groups. Multinomial logistic regression was used to analyze associations with the major types of recommended treatments: bronchodilator therapy, combined long-acting beta-2-antagonists (LABA) + inhaled corticosteroids (ICS), and triple inhaled therapy.

    Results: The proportion of patients with no maintenance treatment, with only LABA + ICS, and with sole ICS statistically significantly decreased (36 vs. 31%, 16 vs. 12% and 5 vs. 2%, respectively), and the proportion with triple inhaled therapy statistically significantly increased (29 vs. 40%). In 2014, triple inhaled therapy was the most common treatment in all GOLD groups except group A. In 2014, previous frequent exacerbations [OR (95% CI) 2.34 (1.62 to 3.36)], worse COPD Assessment Test score [1.07 (1.05 to 1.09)], female sex [2.13 (1.56 to 2.91)], and access to a specific responsible doctor [1.95 (1.41 to 2.69)] were associated with triple inhaled therapy. Current smoking [0.40 (0.28 to 0.57)] and overweight [0.62 (0.41 to 0.93)] were inversely associated with triple inhaled therapy.

    Conclusions: Over the last decade, triple inhaled therapy has increased, and no maintenance treatment, ICS, or LABA + ICS has decreased. Triple inhaled therapy is the most common treatment and is associated with previous exacerbations, higher symptom level, female sex, and having a specific responsible doctor.

1 - 5 of 5
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