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  • 1.
    Ahmadi, Z.
    et al.
    Lund Univ, Lund, Sweden..
    Sundh, J.
    Univ Orebro, Orebro, Sweden..
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Ekström, M.
    Lund Univ, Lund, Sweden..
    Does Long-Term Oxygen Therapy 24 H/day Improve Survival Compared To 15 H/day In Hypoxemic Chronic Obstructive Pulmonary Disease?2016In: American Journal of Respiratory and Critical Care Medicine, ISSN 1073-449X, E-ISSN 1535-4970, Vol. 193Article in journal (Refereed)
  • 2. Ahmadi, Zainab
    et al.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Franklin, Karl A.
    Midgren, Bengt
    Ekstrom, Magnus P.
    Hypo- and hypercapnia predict mortality in oxygen-dependent chronic obstructive pulmonary disease: a population-based prospective study2014In: Respiratory research (Online), ISSN 1465-9921, E-ISSN 1465-993X, Vol. 15, p. 30-Article in journal (Refereed)
    Abstract [en]

    Background: The prognostic role of the arterial blood gas tension of carbon dioxide (PaCO2) in severe Chronic Obstructive Pulmonary Disease (COPD) remains unknown. The aim of this study was to estimate the association between PaCO2 and mortality in oxygen-dependent COPD. Methods: National prospective study of patients starting long-term oxygen therapy (LTOT) for COPD in Sweden between October 1, 2005 and June 30, 2009, with all-cause mortality as endpoint. The association between PaCO2 while breathing air, PaCO2 (air), and mortality was estimated using Cox regression adjusted for age, sex, arterial blood gas tension of oxygen (PaO2), World Health Organization performance status, body mass index, comorbidity, and medications. Results: Of 2,249 patients included, 1,129 (50%) died during a median 1.1 years (IQR 0.6-2.0 years) of observation. No patient was lost to follow-up. PaCO2 (air) independently predicted adjusted mortality (p < 0.001). The association with mortality was U-shaped, with the lowest mortality at approximately PaCO2 (air) 6.5 kPa and increased mortality at PaCO2 (air) below 5.0 kPa and above 7.0 kPa. Conclusion: In oxygen-dependent COPD, PaCO2 (air) is an independent prognostic factor with a U-shaped association with mortality.

  • 3.
    Berling Holm, Katarina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centre for Clinical Research, County of Västmanland. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Otolaryngology and Head and Neck Surgery.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Knutsson, Johan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centre for Clinical Research, County of Västmanland. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Otolaryngology and Head and Neck Surgery. Örebro Univ Hosp, Dept Otolaryngol, Örebro, Sweden.
    von Unge, Magnus
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centre for Clinical Research, County of Västmanland. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Otolaryngology and Head and Neck Surgery. Akershus Univ Hosp, Dept Otorhinolaryngol, Oslo, Norway; Univ Oslo, Oslo, Norway.
    Surgery for Chronic Otitis Media Causes Greater Taste Disturbance Than Surgery for Otosclerosis.2019In: Otology and Neurotology, ISSN 1531-7129, E-ISSN 1537-4505, Vol. 40, no 1, p. e32-e39Article in journal (Refereed)
    Abstract [en]

    Objectives: Patients with otosclerosis more often complain about postoperative taste disturbance than patients with chronic otitis media, which seems paradoxical. We aim to investigate if and potentially why this seems to be the case, since the chorda tympani nerve (CTN) is thought to be severely traumatized less frequently during surgery in the former than in the latter.

    Study Design: Prospective cohort study.

    Setting: Department of Otorhinolaryngology at Hospital of Vastmanland, Vasteras, Sweden.

    Patients: Sixty-five adults undergoing primary middle ear surgery were included. Thirty-seven were operated on for chronic suppurative otitis media with or without cholesteatoma (CSOM) and 28 for otosclerosis.

    Interventions: Middle ear surgery due to otosclerosis or CSOM. Subjective and objective taste measurements and quality of life (QoL) questionnaire.

    Main Outcome Measures: Taste was assessed using electrogustometry (EGM) and the filter paper disc (FPD) method before and up to 1 year after surgery. Questionnaires on taste disturbance, including a visual analogue scale (VAS), and QoL were completed before and up to 1 year after surgery.

    Results: Subjective taste disturbance anytime during the 1-year follow-up were reported by 62 and 46%, respectively. The difference in EGM 1 week after surgery compared with preoperative EGM was significantly greater among CSOM patients than otosclerosis. One year postoperatively, the difference is non-significant.

    Conclusion: Surgery for CSOM causes greater initial and more long-lasting taste disturbances as compared with surgery for otosclerosis. One-year postoperative taste normalizes for both CSOM and otosclerosis patients according to VAS and EGM measurements. No real change in QoL was seen 1-year postoperatively.

    Level of evidence: Level 2 evidence is prospective observational research with an experimental design.

  • 4.
    Bornefalk, Anna
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Information Science.
    The distributions of perceptions and expectations of inflation in Sweden1996Report (Other academic)
  • 5.
    Bornefalk, Anna
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Information Science. Statistik.
    Persson, Ingemar
    Bergström, Reinhold
    Trends in breast cancer mortality among Swedish women 1953-92: analyses by age, period and birth cohort1995In: British Journal of Cancer, ISSN 0007-0920, Vol. 72, no 2, p. 493-497Article in journal (Refereed)
    Abstract [en]

    Trends in breast cancer mortality among Swedish women were explored on the basis of all 51 048 deaths in women 30-89 years of age in Sweden during the period 1953-92. The age-standardised mortality rates were virtually unchanged during the observation period (with a mean of 32 deaths per 100 000 females and year), as were age-specific rates. In age-period-cohort analyses, age alone explained almost all of the variation in the rates. The effects of period and cohort were statistically significant, but very modest. Cohort effects seemed to explain more than period effects, and a weak downward trend starting with women born in 1883-92 was noted. A change in 1981 in the policy to classify the causes of death from the death certificates seemed to entail an artificial lowering of the mortality rates in women older than 75 years. It is concluded that breast cancer mortality in Sweden during the last 40 years has been remarkably stable, in spite of a substantial and constant increase in the incidence. This divergence between mortality and incidence reflects improved survival, which could in part be explained by earlier detection and more efficient treatment, or by an increasing occurrence of less aggressive tumours.

  • 6. Bornefalk, Hans
    et al.
    Hermansson, Anna Bornefalk
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Statistics.
    On the comparison of FROC curves in mammography CAD systems.2005In: Medical physics (Lancaster), ISSN 0094-2405, Vol. 32, no 2, p. 412-7Article in journal (Refereed)
    Abstract [en]

    We present a novel method for assessing the performance of computer-aided detection systems on unseen cases at a given sensitivity level. The sampling error introduced when training the system on a limited data set is captured as the uncertainty in determining the system threshold that would yield a certain predetermined sensitivity on unseen data sets. By estimating the distribution of system thresholds, we construct a confidence interval for the expected number of false positive markings per image at a given sensitivity. We present two alternative procedures for estimating the probability density functions needed for the construction of the confidence interval. The first is based on the common assumption of Poisson distributed number of false positive markings per image. This procedure also relies on the assumption of independence between false positives and sensitivity, an assumption that can be relaxed with the second procedure, which is nonparametric. The second procedure uses the bootstrap applied to the data generated in the leave-one-out construction of the FROC curve, and is a fast and robust way of obtaining the desired confidence interval. Standard FROC curve analysis does not account for the uncertainty in setting the system threshold, so this method should allow for a more fair comparison of different systems. The resulting confidence intervals are surprisingly wide. For our system a conventional FROC curve analysis yields 0.47 false positive markings per image at 90% sensitivity. The 90% confidence interval for the number of false positive markings per image is (0.28, 1.02) with the parametric procedure and (0.27, 1.04) with the nonparametric bootstrap. Due to its computational simplicity and its allowing more fair comparisons between systems, we propose this method as a complement to the traditionally presented FROC curves.

  • 7.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Information Science.
    Evaluation of the bootstrap smoothed conditional (BSC) interval and others in small sample FROC analysis of mammography CAD system performanceManuscript (preprint) (Other academic)
  • 8.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Information Science.
    Evaluation of the bootstrap smoothed conditional (BSC) interval and others in small sample FROC analysis of mammography CAD system performanceManuscript (preprint) (Other academic)
  • 9.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Information Science.
    Resampling Evaluation of Signal Detection and Classification: With Special Reference to Breast Cancer, Computer-Aided Detection and the Free-Response Approach2007Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    The first part of this thesis is concerned with trend modelling of breast cancer mortality rates. By using an age-period-cohort model, the relative contributions of period and cohort effects are evaluated once the unquestionable existence of the age effect is controlled for. The result of such a modelling gives indications in the search for explanatory factors. While this type of modelling is usually performed with 5-year period intervals, the use of 1-year period data, as in Paper I, may be more appropriate.

    The main theme of the thesis is the evaluation of the ability to detect signals in x-ray images of breasts. Early detection is the most important tool to achieve a reduction in breast cancer mortality rates, and computer-aided detection systems can be an aid for the radiologist in the diagnosing process.

    The evaluation of computer-aided detection systems includes the estimation of distributions. One way of obtaining estimates of distributions when no assumptions are at hand is kernel density estimation, or the adaptive version thereof that smoothes to a greater extent in the tails of the distribution, thereby reducing spurious effects caused by outliers. The technique is described in the context of econometrics in Paper II and then applied together with the bootstrap in the breast cancer research area in Papers III-V.

    Here, estimates of the sampling distributions of different parameters are used in a new model for free-response receiver operating characteristic (FROC) curve analysis. Compared to earlier work in the field, this model benefits from the advantage of not assuming independence of detections in the images, and in particular, from the incorporation of the sampling distribution of the system's operating point.

    Confidence intervals obtained from the proposed model with different approaches with respect to the estimation of the distributions and the confidence interval extraction methods are compared in terms of coverage and length of the intervals by simulations of lifelike data.

    List of papers
    1. Trends in breast cancer mortality among Swedish women 1953-92: analyses by age, period and birth cohort
    Open this publication in new window or tab >>Trends in breast cancer mortality among Swedish women 1953-92: analyses by age, period and birth cohort
    1995 In: British Journal of Cancer, ISSN 0007-0920, Vol. 72, p. 493-497Article in journal (Refereed) Published
    Identifiers
    urn:nbn:se:uu:diva-95396 (URN)
    Available from: 2007-01-26 Created: 2007-01-26Bibliographically approved
    2. The distributions of perceptions and expectations of inflation in Sweden
    Open this publication in new window or tab >>The distributions of perceptions and expectations of inflation in Sweden
    1996 (English)Report (Other academic)
    Place, publisher, year, edition, pages
    Uppsala, 1996
    Series
    Research report - University of Uppsala, Department of Statistics ; 1996:8
    Keywords
    Penningvärde; Sverige
    National Category
    Probability Theory and Statistics
    Identifiers
    urn:nbn:se:uu:diva-49737 (URN)
    Available from: 2008-10-17 Created: 2008-10-17 Last updated: 2014-08-18Bibliographically approved
    3. On the comparison of FROC curves in mammography CAD systems
    Open this publication in new window or tab >>On the comparison of FROC curves in mammography CAD systems
    2005 In: Medical Physics, ISSN 0094-2405, Vol. 32, no 2, p. 412-417Article in journal (Refereed) Published
    Identifiers
    urn:nbn:se:uu:diva-95398 (URN)
    Available from: 2007-01-26 Created: 2007-01-26Bibliographically approved
    4. Statistical aspects of threshold independent performance assessment of mammography CAD systems
    Open this publication in new window or tab >>Statistical aspects of threshold independent performance assessment of mammography CAD systems
    Manuscript (Other academic)
    Identifiers
    urn:nbn:se:uu:diva-95399 (URN)
    Available from: 2007-01-26 Created: 2007-01-26 Last updated: 2010-01-13Bibliographically approved
    5. Evaluation of the bootstrap smoothed conditional (BSC) interval and others in small sample FROC analysis of mammography CAD system performance
    Open this publication in new window or tab >>Evaluation of the bootstrap smoothed conditional (BSC) interval and others in small sample FROC analysis of mammography CAD system performance
    Article in journal (Refereed) Submitted
    Identifiers
    urn:nbn:se:uu:diva-95400 (URN)
    Available from: 2007-01-26 Created: 2007-01-26Bibliographically approved
  • 10.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Information Science.
    Statistical aspects of threshold independent performance assessment of mammography CAD systemsManuscript (Other academic)
  • 11.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Information Science.
    Statistical aspects of threshold independent performance assessment of mammography CAD systemsManuscript (preprint) (Other academic)
  • 12.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Information Science.
    The relationship between the number of employed in manufacturing and business survey series in Sweden 1972-19941997Report (Other academic)
  • 13. Ekstrom, Magnus P.
    et al.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Strom, Kerstin E.
    Effects of Cardiovascular Drugs on Mortality in Severe Chronic Obstructive Pulmonary Disease: A Time-Dependent Analysis2013In: American Journal of Respiratory and Critical Care Medicine, ISSN 1073-449X, E-ISSN 1535-4970, Vol. 187, no 7, p. 715-720Article in journal (Refereed)
    Abstract [en]

    Rationale:

    Cardiovascular drugs may improve survival in chronic obstructive pulmonary disease (COPD). However, previous studies did not account for major sources of bias, and drug effects have not been evaluated in severe COPD.

    Objectives:

    To estimate the time-dependent effects of cardiovascular drugs on survival in oxygen-dependent COPD, accounting for immortal and immeasurable time bias.

    Methods:

    Prospective national study of patients starting long-term oxygen therapy for COPD in Sweden between 1 October 2005 and 30 June 2009. Effects on mortality were estimated using extended Cox regression adjusted for age, sex, Pa-O2, Pa-CO2, World Health Organization performance status, body mass index, comorbidity, and concomitant medications. Immortal and immeasurable time bias was addressed by analyzing all medications as time-dependent variables and accounting for hospitalized time, respectively.

    Measurements and Main Results:

    Time-dependent effects of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, antiplatelet drugs, beta-blockers, and statins on all-cause mortality were measured. Of the 2,249 included patients, 1,129 (50%) died under observation. No patient was lost to follow-up. The adjusted time-dependent model was compatible with reduced mortality for antiplatelet drugs (hazard ratio [HR], 0.86; 95% CI, 0.75-0.99; P = 0.030) and trends for angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (HR, 0.90; 95% CI, 0.79-1.04; P = 0.166) and statins (HR, 0.86; 95% CI, 0.72-1.03; P = 0.105), whereas beta-blockers increased mortality (HR, 1.19; 95% CI, 1.04-1.37; P = 0.010). Conclusions: This study supports that antiplatelet drugs improve survival

  • 14. Ekstrom, Magnus P.
    et al.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Abernethy, Amy P.
    Currow, David C.
    Safety of benzodiazepines and opioids in very severe respiratory disease: national prospective study2014In: BMJ. British Medical Journal, E-ISSN 1756-1833, Vol. 348, p. g445-Article in journal (Refereed)
    Abstract [en]

    Objective To evaluate the safety of benzodiazepines and opioids in patients with very severe chronic obstructive pulmonary disease (COPD). Design Population based longitudinal consecutive cohort study. Setting Centres prescribing long term oxygen therapy in Sweden. Patients 2249 patients starting long term oxygen therapy for COPD in Sweden between 2005 and 2009 in the national Swedevox Register. Main outcome measures Effects of benzodiazepines and opioids on rates of admission to hospital and mortality, adjusted for age, sex, arterial blood gases, body mass index (BMI), performance status, previous admissions, comorbidities, and concurrent drugs. Results 1681 (76%) patients were admitted to hospital, and 1129 (50%) died under observation. No patient was lost to follow-up. Benzodiazepines and opioids were not associated with increased admission: hazard ratio 0.98 (95% confidence interval, 0.87 to 1.10) and 0.98 (0.86 to 1.10), respectively. Benzodiazepines were associated with increased mortality (1.21, 1.05 to 1.39) with a dose response trend. Opioids also had a dose response relation with mortality: lower dose opioids (<= 30 mg oral morphine equivalents a day) were not associated with increased mortality (1.03, 0.84 to 1.26) in contrast with higher dose opioids (1.21, 1.02 to 1.44). Concurrent benzodiazepines and opioids in lower doses were not associated with increased admissions (0.86, 0.53 to 1.42) or mortality (1.25, 0.78 to 1.99). Associations were not modified by being naive to the drugs or by hypercapnia. Conclusions Lower dose opioids are not associated with increased admissions or deaths in patients with COPD and might be safe for symptom reduction in severe respiratory disease.

  • 15. Ekstrom, Magnus P.
    et al.
    Hermansson, Anna Bornefalk
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Strom, Kerstin E.
    Effects of Cardiovascular rugs on Mortality in Severe Chronic Obstructive Pulmonary Disease A Time-Dependent Analysis2013In: American Journal of Respiratory and Critical Care Medicine, ISSN 1073-449X, E-ISSN 1535-4970, Vol. 187, no 7, p. 715-720Article in journal (Refereed)
    Abstract [en]

    Rationale: Cardiovascular drugs may improve survival in chronic obstructive pulmonary disease (COPD). However, previous studies did not account for major sources of bias, and drug effects have not been evaluated in severe COPD. Objectives: To estimate the time-dependent effects of cardiovascular drugs on survival in oxygen-dependent COPD, accounting for immortal and immeasurable time bias. Methods: Prospective national study of patients starting long-term oxygen therapy for COPD in Sweden between 1 October 2005 and 30 June 2009. Effects on mortality were estimated using extended Cox regression adjusted for age, sex, Pa-O2, Pa-CO2, World Health Organization performance status, body mass index, comorbidity, and concomitant medications. Immortal and immeasurable time bias was addressed by analyzing all medications as time-dependent variables and accounting for hospitalized time, respectively. Measurements and Main Results: Time-dependent effects of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, antiplatelet drugs, beta-blockers, and statins on all-cause mortality were measured. Of the 2,249 included patients, 1,129 (50%) died under observation. No patient was lost to follow-up. The adjusted time-dependent model was compatible with reduced mortality for antiplatelet drugs (hazard ratio [HR], 0.86; 95% CI, 0.75-0.99; P = 0.030) and trends for angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (HR, 0.90; 95% CI, 0.79-1.04; P = 0.166) and statins (HR, 0.86; 95% CI, 0.72-1.03; P = 0.105), whereas beta-blockers increased mortality (HR, 1.19; 95% CI, 1.04-1.37; P = 0.010). Conclusions: This study supports that antiplatelet drugs improve survival

  • 16.
    Ekström, M.
    et al.
    Lund Univ, Div Resp Med & Allergol, Dept Clin Sci, Lund, Sweden..
    Ahmadi, Z.
    Lund Univ, Div Resp Med & Allergol, Dept Clin Sci, Lund, Sweden..
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Statistics.
    Currow, D.
    Flinders Univ S Australia, Adelaide, SA, Australia..
    Oxygen For Breathlessness In Patients With COPD Who Do Not Qualify For Home Oxygen Therapy: An Updated Cochrane Analysis2017In: American Journal of Respiratory and Critical Care Medicine, ISSN 1073-449X, E-ISSN 1535-4970, Vol. 195, article id A5450Article in journal (Other academic)
  • 17.
    Ekström, Magnus
    et al.
    Lund Univ, Dept Clin Sci, Div Resp Med & Allergol, Lund, Sweden..
    Ahmadi, Zainab
    Lund Univ, Dept Clin Sci, Div Resp Med & Allergol, Lund, Sweden..
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Statistics.
    Abernethy, Amy
    Duke Univ, Med Ctr, CLHC, Durham, NC USA..
    Currow, David
    Flinders Univ S Australia, Dept Palliat & Support Serv, Daw Pk, Australia..
    Oxygen for breathlessness in patients with chronic obstructive pulmonary disease who do not qualify for home oxygen therapy2016In: Cochrane Database of Systematic Reviews, ISSN 1469-493X, E-ISSN 1469-493X, no 11, article id CD006429Article, review/survey (Refereed)
    Abstract [en]

    Background: Breathlessness is a cardinal symptom of chronic obstructive pulmonary disease (COPD). Long-term oxygen therapy (LTOT) is given to improve survival time in people with COPD and severe chronic hypoxaemia at rest. The efficacy of oxygen therapy for breathlessness and health-related quality of life (HRQOL) in people with COPD and mild or no hypoxaemia who do not meet the criteria for LTOT has not been established. Objectives: To determine the efficacy of oxygen versus air in mildly hypoxaemic or non-hypoxaemic patients with COPD in terms of (1) breathlessness; (2) HRQOL; (3) patient preference whether to continue therapy; and (4) oxygen-related adverse events. Search methods: We searched the Cochrane Airways Group Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase, to 12 July 2016, for randomised controlled trials (RCTs). We handsearched the reference lists of included articles. Selection criteria: We included RCTs of the effects of non-invasive oxygen versus air on breathlessness, HRQOL or patient preference to continue therapy among people with COPD and mild or no hypoxaemia (partial pressure of oxygen (PaO2) >7.3 kPa) who were not already receiving LTOT. Two review authors independently assessed articles for inclusion in the review. Data collection and analysis: Two review authors independently collected and analysed data. We assessed risk of bias by using the Cochrane 'Risk of bias tool'. We pooled effects recorded on different scales as standardised mean differences (SMDs) with 95% confidence intervals (CIs) using random-effects models. Lower SMDs indicated decreased breathlessness and reduced HRQOL. We performed subanalyses and sensitivity analyses and assessed the quality of evidence according to the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Main results: Compared with the previous review, which was published in 2011, we included 14 additional studies (493 participants), excluded one study and included data for meta-analysis of HRQOL. In total, we included in this review 44 studies including 1195 participants, and we included 33 of these (901 participants) in the meta-analysis. We found that breathlessness during exercise or daily activities was reduced by oxygen compared with air (32 studies; 865 participants; SMD -0.34, 95% CI -0.48 to -0.21; I-2 = 37%; low-quality evidence). This translates to a decrease in breathlessness of about 0.7 points on a 0 to 10 numerical rating scale. In contrast, we found no effect of short-burst oxygen given before exercise (four studies; 90 participants; SMD 0.01, 95% CI -0.26 to 0.28; I-2 = 0%; low-quality evidence). Oxygen reduced breathlessness measured during exercise tests (25 studies; 442 participants; SMD-0.34, 95% CI -0.46 to -0.22; I-2 = 29%; moderate-quality evidence), whereas evidence of an effect on breathlessness measured in daily life was limited (two studies; 274 participants; SMD -0.13, 95% CI, -0.37 to 0.11; I-2 = 0%; low-quality evidence). Oxygen did not clearly affectHRQOL (five studies; 267 participants; SMD 0.10, 95% CI -0.06 to 0.26; I-2 = 0%; low-quality evidence). Patient preference and adverse events could not be analysed owing to insufficient data. Authors' conclusions: We are moderately confident that oxygen can relieve breathlessness when given during exercise to mildly hypoxaemic and non-hypoxaemic people with chronic obstructive pulmonary disease who would not otherwise qualify for home oxygen therapy. Most evidence pertains to acute effects during exercise tests, and no evidence indicates that oxygen decreases breathlessness in the daily life setting. Findings show that oxygen does not affect health-related quality of life.

  • 18. Ekström, Magnus
    et al.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Wysham, Nicholas
    Currow, David C
    MacIntyre, Neil
    Spirometric Volumes and Breathlessness Across Levels of Airflow Limitation: The COPDGene Study.2018In: American Journal of Respiratory and Critical Care Medicine, ISSN 1073-449X, E-ISSN 1535-4970, Vol. 198, no 5, p. 678-681Article in journal (Refereed)
  • 19. Ekström, Magnus
    et al.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Statistics.
    Cardiovascular and antacid treatment and mortality in oxygen-dependent pulmonary fibrosis: A population-based longitudinal study2016In: Respirology (Carlton South. Print), ISSN 1323-7799, E-ISSN 1440-1843, Vol. 21, no 4, p. 705-711Article in journal (Refereed)
    Abstract [en]

    BACKGROUND AND OBJECTIVE: Severe idiopathic pulmonary fibrosis is associated with an increased risk of cardiovascular disease and gastro-oesophageal reflux, which may influence prognosis. We evaluated associations between cardiovascular and antacid medications, and mortality, in oxygen-dependent pulmonary fibrosis (PF) of unknown cause.

    METHODS: Prospective population-based study of adults starting long-term oxygen therapy (LTOT) for PF in Sweden 2005-2009. PF of unknown cause was defined by excluding patients with known or probable secondary PF. Time-dependent associations between medications and all-cause mortality were analysed using extended Cox regression, adjusting for potential confounders including age, sex, vital capacity, blood gases, body mass index, performance status, comorbidity and concurrent medications.

    RESULTS: Of 462 included patients, 329 (71%) died under observation. No patient was lost to follow-up. Angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEI/ARB) were associated with reduced adjusted mortality (HR 0.63; 0.47-0.85) and antiplatelet drugs with increased mortality (HR 1.49; 1.11-2.00), largely driven by higher mortality in women. There were no associations with mortality for antacid treatments, β-blockers, diuretics or statins.

    CONCLUSION: In oxygen-dependent PF, treatment with ACEI/ARB was associated with improved survival, antiplatelet drugs with decreased survival, whereas there was no association between antacid, β-blocker, diuretic or statin treatment and survival.

  • 20. Ekström, Magnus
    et al.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Abernethy, Amy
    Currow, David
    Low-dose opioids should be considered for symptom relief also in advanced chronic obstructive pulmonary disease (COPD)2015In: Evidence-Based Medicine, ISSN 1356-5524, E-ISSN 1473-6810, ISSN 1356-5524, Vol. 20, no 1, p. 39-, article id 10.1136/ebmed-2014-110130Article in journal (Refereed)
  • 21.
    Isacsson, Göran
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centre for Clinical Research, County of Västmanland. Västmanland Cty Hosp, Orofacial Pain & Jaw Funct, Västerås, Sweden.
    Nohlert, Eva
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centre for Clinical Research, County of Västmanland.
    Fransson, A.
    Postgrad Dent Educ Ctr Örebro, Dent Sleep Med Clin, Örebro, Sweden.
    WimanEriksson, E.
    Postgrad Dent Educ Ctr Örebro, Dent Sleep Med Clin, Örebro, Sweden.
    Ortlieb, E.
    Postgrad Dent Educ Ctr Örebro, Dent Sleep Med Clin, Örebro, Sweden.
    Fodor, C.
    Västmanland Cty Hosp, Orofacial Pain & Jaw Funct, Västerås, Sweden.
    Schumann, M.
    Västmanland Cty Hosp, Orofacial Pain & Jaw Funct, Västerås, Sweden.
    Sturebrand, M.
    Västmanland Cty Hosp, Orofacial Pain & Jaw Funct, Västerås, Sweden.
    Trepp, L.
    Postgrad Dent Educ Ctr Örebro, Dent Sleep Med Clin, Örebro, Sweden.
    Avdelius, A.
    Malmö Univ, Orofacial Pain & Jaw Funct, Malmö, Sweden.
    Tegelberg, Å.
    Malmö Univ, Orofacial Pain & Jaw Funct, Malmö, Sweden; Postgrad Dent Educ Ctr Örebro, Dept Orthodont, Örebro, Sweden.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Bibloc and monobloc oral appliances in the treatment of obstructive sleep apnoea: a multicenter, randomized, blinded, parallel-group trial2017In: Sleep Medicine, ISSN 1389-9457, E-ISSN 1878-5506, Vol. 40, no Supplement 1, p. E142-E143Article in journal (Refereed)
  • 22.
    Isacsson, Göran
    et al.
    Västmanland Cty Hosp, Dept Orofacial Pain & Jaw Funct, Västerås, Sweden.
    Nohlert, Eva
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centre for Clinical Research, County of Västmanland.
    Fransson, Anette M C
    Örebro Univ, Publ Dent Serv, Dent Res, Dept Orthodont, Örebro, Region Örebro C, Sweden; Örebro Univ, Fac Med & Hlth, Örebro, Sweden; Örebro Univ, Publ Dent Serv, Dept Dent Sleep Med, Örebro, Region Örebro C, Sweden.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Wiman Eriksson, Eva
    Örebro Univ, Publ Dent Serv, Dept Dent Sleep Med, Örebro, Region Örebro C, Sweden.
    Ortlieb, Eva
    Örebro Univ, Publ Dent Serv, Dept Dent Sleep Med, Örebro, Region Örebro C, Sweden.
    Trepp, Livia
    Örebro Univ, Publ Dent Serv, Dept Dent Sleep Med, Örebro, Region Örebro C, Sweden.
    Avdelius, Anna
    Malmö Univ, Dept Orofacial Pain & Jaw Funct, Malmö, Sweden.
    Sturebrand, Magnus
    Västmanland Cty Hosp, Dept Orofacial Pain & Jaw Funct, Västerås, Sweden.
    Fodor, Clara
    Västmanland Cty Hosp, Dept Orofacial Pain & Jaw Funct, Västerås, Sweden.
    List, Thomas
    Malmö Univ, Dept Orofacial Pain & Jaw Funct, Malmö, Sweden.
    Schumann, Mohamad
    Västmanland Cty Hosp, Dept Orofacial Pain & Jaw Funct, Västerås, Sweden.
    Tegelberg, Åke
    Örebro Univ, Publ Dent Serv, Dept Dent Sleep Med, Örebro, Region Örebro C, Sweden; Malmö Univ, Dept Orofacial Pain & Jaw Funct, Malmö, Sweden.
    Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial2019In: European Journal of Orthodontics, ISSN 0141-5387, E-ISSN 1460-2210, Vol. 41, no 1, p. 80-88Article in journal (Refereed)
    Abstract [en]

    Background: The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA.

    Objective: To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective.

    Patients and methods: In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were randomly assigned to use either a bibloc or a monobloc appliance. One-night respiratory polygraphy without respiratory support was performed at baseline, and participants were re-examined with the appliance in place at short-term follow-up. The primary outcome was the change in the apnoea–hypopnea index (AHI). An independent person prepared a randomization list and sealed envelopes. Evaluating dentist and the biomedical analysts who evaluated the polygraphy were blinded to the choice of therapy.

    Results: Of 302 patients, 146 were randomly assigned to use the bibloc and 156 the monobloc device; 123 and 139 patients, respectively, were analysed as per protocol. The mean changes in AHI were −13.8 (95% confidence interval −16.1 to −11.5) in the bibloc group and −12.5 (−14.8 to −10.3) in the monobloc group. The difference of −1.3 (−4.5 to 1.9) was significant within the equivalence interval (P = 0.011; the greater of the two P values) and was confirmed by the intention-to-treat analysis (P = 0.001). The adverse events were of mild character and were experienced by similar percentages of patients in both groups (39 and 40 per cent for the bibloc and monobloc group, respectively).

    Limitations: The study shows short-term results with a median time from commencing treatment to the evaluation visit of 56 days and long-term data on efficacy and harm are needed to be fully conclusive.

    Conclusion: In a short-term perspective, both appliances were equivalent in terms of their positive effects for treating OSA and caused adverse events of similar magnitude.

    Trial registration: Registered with ClinicalTrials.gov (#NCT02148510).

  • 23. Johnston, N.
    et al.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Held, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Schenck-Gustafsson, K.
    Female gender associated with less use of reperfusion in ST-elevation myocardial infarction: a study from the RIKS-HIA registry2012In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 33, no Suppl 1, p. 468-469Article in journal (Other academic)
  • 24. Johnston, Nina
    et al.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Held, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Schenck-Gustafsson, Karin
    Gender perspectives on adherence to treatment guidelines in patients with acute myocardial infarction in Sweden2012In: Circulation, ISSN 0009-7322, E-ISSN 1524-4539, Vol. 125, no 19, p. E667-E667Article in journal (Other academic)
  • 25.
    Johnston, Nina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Schenck-Gustafsson, Karin
    Held, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Goodman, Shaun G
    Yan, Andrew T
    Bierman, Arlene S
    Do clinical factors explain persistent sex disparities in the use of acute reperfusion therapy in STEMI in Sweden and Canada?2013In: European heart journal. Acute cardiovascular care., ISSN 2048-8726, Vol. 2, no 4, p. 350-358Article in journal (Refereed)
    Abstract [en]

    AIMS:

    This study examined clinical factors associated with sex differences in the use of acute reperfusion therapy (fibrinolysis or primary percutaneous coronary intervention) in ST-elevation myocardial infarction (STEMI) patients, and the interaction between sex and these factors in Sweden and Canada.

    METHODS:

    Patients with STEMI in Sweden (n=32,676 from the Register of Information and Knowledge about Swedish Heart Intensive Care Admissions) were compared with similar patients in Canada (n=3375 from the Canadian Global Registry of Acute Coronary Events) for the period 2004-2008.

    RESULTS:

    Unadjusted vs. age-adjusted odds ratios (OR) for no reperfusion (women vs. men) were for Sweden 1.57 (95% CI 1.49-1.64) vs. 1.14 (95% CI 1.08-1.20), and for Canada 1.61 (95% CI 1.39-1.87) vs. OR 1.18 (95% CI 1.01-1.39). Sex differences persisted after multivariable adjustments (including prehospital delay, atypical symptoms, diabetes), factors for which no interaction with sex was found. Among women <60 years, adjusting for atypical symptoms in Canada and angiographic data in Sweden made the greatest contribution to explaining observed sex differences.

    CONCLUSIONS:

    In both countries, acute reperfusion therapy in STEMI was used less often in women than in men. Factors associated with these sex differences appear to differ between older and younger women. Targeted interventions are needed to optimize care for women with STEMI, as well as sex- and age-stratified reporting of quality indicators to assess their effectiveness.

  • 26.
    Lampa, Erik
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Occupational and Environmental Medicine.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lind, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Lind, P. Monica
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Occupational and Environmental Medicine.
    Mixture Effects of Multiple Environmental Contaminants on the Metabolic Syndrome in a Human Population-based SampleManuscript (preprint) (Other academic)
  • 27.
    Lampa, Erik
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Occupational and Environmental Medicine.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lind, P. Monica
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Occupational and Environmental Medicine.
    Lind, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Atherosclerosis in Humans and the Association to Environmental Contaminant MixturesManuscript (preprint) (Other academic)
  • 28.
    Lampa, Erik
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Occupational and Environmental Medicine.
    Lind, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Bornefalk Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Salihovic, Samira
    van Bavel, Bert
    Lind, P. Monica
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Occupational and Environmental Medicine.
    An investigation of the co-variation in circulating levels of a large number of environmental contaminants2012In: Journal of Exposure Science and Environmental Epidemiology, ISSN 1559-0631, E-ISSN 1559-064X, Vol. 22, no 5, p. 476-482Article in journal (Refereed)
    Abstract [en]

    We are daily exposed to many different environmental contaminants. Mixtures of these contaminants could act together to induce more pronounced effects than the sum of the individual contaminants. To evaluate the effects of such mixtures, it is of importance to assess the co-variance amongst the contaminants. Thirty-seven environmental contaminants representing different classes were measured in blood samples from 1016 individuals aged 70 years. Hierarchical cluster analysis and principal component analysis were used to assess the co-variation among the contaminants. Within each identified cluster, possible marker contaminants were sought for. We validated our findings using data from the National Health and Nutrition Examination Survey (NHANES) 2003--2004 study. Two large clusters could be identified, one representing low/medium chlorinated polychlorinated biphenyls (PCBs) (<= 6 chlorine atoms), as well as two pesticides and one representing medium/high chlorinated PCBs (>= 6 chlorine atoms). PCBs 118 and 153 could be used as markers for the low/medium chlorinated cluster and PCBs 170 and 209 could be used as markers for the medium/high chlorinated cluster. This pattern was similar to data from the NHANES study. Apart from the PCBs, little co-variation was seen among the contaminants. Thus, a large number of chemicals have to be measured to adequately identify mixtures of environmental contaminants.

  • 29.
    Lampa, Erik
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Occupational and Environmental Medicine.
    Lind, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Lind, Monica P.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Occupational and Environmental Medicine.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    The identification of complex interactions in epidemiology and toxicology: a simulation study of Boosted Regression Trees2014In: Environmental health, ISSN 1476-069X, E-ISSN 1476-069X, Vol. 13, p. 57-Article in journal (Refereed)
    Abstract [en]

    Background: There is a need to evaluate complex interaction effects on human health, such as those induced by mixtures of environmental contaminants. The usual approach is to formulate an additive statistical model and check for departures using product terms between the variables of interest. In this paper, we present an approach to search for interaction effects among several variables using boosted regression trees. Methods: We simulate a continuous outcome from real data on 27 environmental contaminants, some of which are correlated, and test the method's ability to uncover the simulated interactions. The simulated outcome contains one four-way interaction, one non-linear effect and one interaction between a continuous variable and a binary variable. Four scenarios reflecting different strengths of association are simulated. We illustrate the method using real data. Results: The method succeeded in identifying the true interactions in all scenarios except where the association was weakest. Some spurious interactions were also found, however. The method was also capable to identify interactions in the real data set. Conclusions: We conclude that boosted regression trees can be used to uncover complex interaction effects in epidemiological studies.

  • 30.
    Sundh, Josefin
    et al.
    Orebro Univ, Sch Med Sci, Dept Resp Med, Orebro, Sweden.
    Bornefalk-Hermansson, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Ahmadi, Zainab
    Lund Univ, Div Resp Med & Allergol, Dept Clin Sci, Lund, Sweden.
    Blomberg, Anders
    Umea Univ, Div Med Resp Med, Dept Publ Hlth & Clin Med, Umea, Sweden.
    Janson, Christer
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Lung- allergy- and sleep research.
    Currow, David C.
    Univ Technol, Fac Hlth, Sydney, NSW, Australia.
    McDonald, Christine F.
    Inst Breathing & Sleep, Melbourne, Vic, Australia.
    McCaffrey, Nikki
    Deakin Univ, Deakin Hlth Econ, Burwood, Vic, Australia.
    Ekstrom, Magnus
    Lund Univ, Div Resp Med & Allergol, Dept Clin Sci, Lund, Sweden.
    REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol2019In: BMC Pulmonary Medicine, ISSN 1471-2466, E-ISSN 1471-2466, Vol. 19, article id 50Article in journal (Refereed)
    Abstract [en]

    Objective:Long-term oxygen therapy (LTOT) during 15 h/day or more prolongs survival in patients with chronicobstructive pulmonary disease (COPD) and severe hypoxemia. No randomized controlled trial has evaluated the neteffects (benefits or harms) from LTOT 24 h/day compared with 15 h/day or the effect in conditions other than COPD.We describe a multicenter, national, phase IV, non-superiority, registry-based, randomized controlled trial (R-RCT) ofLTOT prescribed 24 h/day compared with 15 h/day. The primary endpoint is all-cause-mortality at 1 year. Secondaryendpoints include cause-specific mortality, hospitalizations, health-related quality of life, symptoms, and outcomes ininterstitial lung disease.

    Methods/design:Patients qualifying for LTOT are randomized to LTOT 24 h/day versus 15 h/day during 12 monthsusing the Swedish Register for Respiratory Failure (Swedevox). Planned sample size in this pragmatic study is 2126randomized patients. Clinical follow-up and concurrent treatments are according to routine clinical practice. Mortality,hospitalizations, and incident diseases are assessed using national Swedish registries with expected complete follow-up. Patient-reported outcomes are assessed using postal questionnaire at 3 and 12 months.

    Discussion:The R-RCT approach combines the advantages of a prospective randomized trial and large clinical nationalregistries for enrollment, allocation, and data collection, with the aim of improving the evidence-based use of LTOT.

    Trial registration:Clinical Trial registered withwww.clinicaltrials.gov, Title: REgistry-based Treatment Duration andMortality in Long-term OXygen Therapy (REDOX); ID: NCT03441204.

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