Publications by authors named "Niklas Karlsson"

50 Publications

Objectively Measured Physical Activity in Patients with COPD: Recommendations from an International Task Force on Physical Activity.

Chronic Obstr Pulm Dis 2021 08 25. Epub 2021 Aug 25.

Reval Rehabilitation Research Center, Biomed Biomedical Research Institute, Hasselt University, Diepenbeek, Belgium.

Physical activity (PA) is of key importance for health among healthy persons and individuals with COPD. PA has multiple dimensions that can be assessed and quantified objectively using activity monitors. Moreover, as shown in the published literature, variable methodologies have been used to date to quantify PA among individuals with COPD, precluding clear comparisons of outcomes across studies. The present paper aims to provide a summary of the available literature for the rationale behind using objectively measured PA and proposes a standardized methodology for assessment, including standard operating procedures for future research. The present paper therefore describes the concept of PA, reports on the importance of PA, summarizes the dimensions of PA, provides a standard operating procedure how to monitor PA using objective assessments and describes the psychometric properties of objectively measured PA. The present international task force recommends implementation of the standard operating procedure for PA data collection and reporting in the future. This should allow to further clarify the relationship between PA and clinical outcomes, to test the impact of treatment interventions on PA in individuals with COPD and to successfully propose a PA endpoint for regulatory qualification in the future.
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http://dx.doi.org/10.15326/jcopdf.2021.0213DOI Listing
August 2021

Development of a preliminary conceptual model of the patient experience of chronic kidney disease: a targeted literature review and analysis.

BMC Nephrol 2021 Jun 23;22(1):233. Epub 2021 Jun 23.

R&D Digital Health, AstraZeneca, Gothenburg, Sweden.

Background: Patient-reported outcome (PRO) instruments should capture the experiences of disease and treatment that patients consider most important in order to inform patient-centred care and product development. The aim of this study was to develop a preliminary conceptual model of patient experience in chronic kidney disease (CKD) based on a targeted literature review and to characterize existing PRO instruments used in CKD.

Methods: PubMed, EMBASE and Cochrane databases and recent society meetings were searched for publications reporting signs/symptoms and life impacts of CKD. Concepts identified in the literature review were used to develop a preliminary conceptual model of patient experience of CKD, overall, and within patient subpopulations of differing CKD causes, severities and complications. PRO instruments, identified from PRO databases, CKD literature and CKD clinical trials, were assessed for content validity, psychometric strength and coverage of concepts in the literature review.

Results: In total, 100 publications met criteria for analysis; 56 signs/symptoms and 37 life impacts of CKD were identified from these sources. The most frequently mentioned signs/symptoms were pain/discomfort (57% of publications) and tiredness/low energy/lethargy/fatigue (42%); the most commonly reported life impacts were anxiety/depression (49%) and decrements in physical functioning (43%). Signs/symptoms and life impacts varied across the subpopulations and were more frequent at advanced CKD stages. The preliminary conceptual model grouped signs/symptoms into seven domains (pain/discomfort; energy/fatigue; sleep-related; gastrointestinal-related; urinary-related; skin-/hair-/nails-related; and other) and life impacts into six domains (psychological/emotional strain; cognitive impairment; dietary habit disruption; physical function decrements; interference with social relationships; and other). Eleven PRO instruments were considered to be promising for use in CKD; all had limitations.

Conclusions: Although preliminary, the proposed conceptual model highlights key PROs for people with CKD and is intended to spur development of more tailored PRO instruments to assess these concepts.
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http://dx.doi.org/10.1186/s12882-021-02440-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220773PMC
June 2021

Heterogeneity within and between physician-diagnosed asthma and/or COPD: NOVELTY cohort.

Eur Respir J 2021 Jul 1. Epub 2021 Jul 1.

Respiratory Medical Evidence Strategy, BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.

Background: Studies of asthma and chronic obstructive pulmonary disease (COPD) typically focus on these diagnoses separately, limiting understanding of disease mechanisms and treatment options. NOVELTY is a global, 3-year, prospective observational study of patients with asthma and/or COPD from real-world clinical practice. We investigated heterogeneity and overlap by diagnosis and severity in this cohort.

Methods: Patients with physician-assigned asthma, COPD or both (asthma+COPD) were enrolled, stratified by diagnosis and severity. Baseline characteristics were reported descriptively by physician-assigned diagnosis and/or severity. Factors associated with physician-assessed severity were evaluated using ordinal logistic regression analysis.

Results: Of 11 243 patients, 5940 (52.8%) had physician-assigned asthma, 1396 (12.4%) had asthma+COPD and 3907 (34.8%) had COPD; almost half were from primary care. Symptoms, health-related quality of life and spirometry showed substantial heterogeneity and overlap between asthma, asthma+COPD and COPD, with 23%, 62% and 64% of patients, respectively, having post-bronchodilator FEV/FVC
Conclusion: This analysis demonstrates marked heterogeneity within, and overlap between, physician-assigned diagnosis and severity groups in patients with asthma and/or COPD. Current diagnostic and severity classifications in clinical practice poorly differentiate between clinical phenotypes that may have specific risks and treatment implications.
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http://dx.doi.org/10.1183/13993003.03927-2020DOI Listing
July 2021

Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD.

ERJ Open Res 2021 Jan 1;7(1). Epub 2021 Feb 1.

Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.

Background: The Respiratory Symptoms Questionnaire (RSQ) is a novel, four-item patient-reported diagnosis-agnostic tool designed to assess the frequency of respiratory symptoms and their impact on activity, without specifying a particular diagnosis. Our objective was to examine its validity in patients with asthma and/or chronic obstructive pulmonary disease (COPD).

Methods: Baseline data were randomly sampled from patients who completed the RSQ in the NOVELTY study (ClinicalTrials.gov: NCT02760329). The total sample (n=1530) comprised three randomly selected samples (n=510 each) from each physician-assigned diagnostic group (asthma, asthma+COPD and COPD). The internal consistency and structural validity of the RSQ were evaluated using exploratory and confirmatory factor analyses; psychometric performance was observed using Classical Test Theory and Item Response Theory analyses.

Results: For the total sample, the mean±sd RSQ score was 5.6±4.3 (range 0-16). Irrespective of diagnosis, the internal consistency of items was uniformly adequate (Cronbach's α=0.76-0.80). All items had high factor loadings and structural characteristics of the measure were invariant across groups. Using the total sample, RSQ items informatively covered the θ score range of -2.0 to 2.8, with discrimination coefficients for individual items being high to very high (1.7-2.6). Strong convergent correlations were observed between the RSQ and the St George's Respiratory Questionnaire (0.77, p<0.001).

Conclusions: The RSQ is a valid, brief, patient-reported tool for assessing respiratory symptoms in patients across the whole spectrum of asthma and/or COPD, rather than using different questionnaires for each diagnosis. It can be used for monitoring respiratory symptoms in clinical practice, clinical trials and real-world studies.
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http://dx.doi.org/10.1183/23120541.00828-2020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7861031PMC
January 2021

Validity and responsiveness of the Daily- and Clinical visit-PROactive Physical Activity in COPD (D-PPAC and C-PPAC) instruments.

Thorax 2021 03 21;76(3):228-238. Epub 2021 Jan 21.

Department of Respiratory Diseases, University Hospital Leuven, Leuven, Belgium.

Background: The Daily-PROactive and Clinical visit-PROactive Physical Activity (D-PPAC and C-PPAC) instruments in chronic obstructive pulmonary disease (COPD) combines questionnaire with activity monitor data to measure patients' experience of physical activity. Their amount, difficulty and total scores range from 0 (worst) to 100 (best) but require further psychometric evaluation.

Objective: To test reliability, validity and responsiveness, and to define minimal important difference (MID), of the D-PPAC and C-PPAC instruments, in a large population of patients with stable COPD from diverse severities, settings and countries.

Methods: We used data from seven randomised controlled trials to evaluate D-PPAC and C-PPAC internal consistency and construct validity by sex, age groups, COPD severity, country and language as well as responsiveness to interventions, ability to detect change and MID.

Results: We included 1324 patients (mean (SD) age 66 (8) years, forced expiratory volume in 1 s 55 (17)% predicted). Scores covered almost the full range from 0 to 100, showed strong internal consistency after stratification and correlated as a priori hypothesised with dyspnoea, health-related quality of life and exercise capacity. Difficulty scores improved after pharmacological treatment and pulmonary rehabilitation, while amount scores improved after behavioural physical activity interventions. All scores were responsive to changes in self-reported physical activity experience (both worsening and improvement) and to the occurrence of COPD exacerbations during follow-up. The MID was estimated to 6 for amount and difficulty scores and 4 for total score.

Conclusions: The D-PPAC and C-PPAC instruments are reliable and valid across diverse COPD populations and responsive to pharmacological and non-pharmacological interventions and changes in clinically relevant variables.
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http://dx.doi.org/10.1136/thoraxjnl-2020-214554DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892393PMC
March 2021

A prospective cohort study of risk behaviours, retention and loss to follow-up over 5 years among women and men in a needle exchange program in Stockholm, Sweden.

Int J Drug Policy 2021 04 24;90:103059. Epub 2020 Dec 24.

Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.

Background: Needle exchange programs (NEP) are important in reducing risk behaviours among people who inject drugs (PWID), also exposed to HIV and hepatitis C (HCV) through injecting drug use (IDU). Women (WWID) compared to men who inject drugs (MWID), are particularly vulnerable with complex needs, however less is known about their risk determinants and NEP outcomes.

Methods: In an open prospective NEP cohort, 697 WWID and 2122 MWID were followed, 2013-2018. Self-reported socio/drug-related determinants for receptive injection (needle/syringe and paraphernalia) and sexual risk behaviours at enrolment, lost to follow-up (LTFU) and probability of retention, were assessed for both groups. Multivariable logistic regression (adjusted odds ratios, aOR) for enrolment and Poisson regression (adjusted incidence rate ratios, aIRR) for LTFU, were used. Cumulative NEP-retention probability was analysed using a six- and 12-month scenario.

Results: At NEP enrolment, injection risk behaviours among WWID were associated with: younger age; homelessness; amphetamine-IDU; non-participation in opioid substitution therapy (OST); history of custody and among MWID: lower education level; cohabitation; homelessness, being a tenant; amphetamine-IDU; non-participation in OST; history of being sectioned, HIV-negative and HCV-positive. Condomless sex among WWID was associated with: younger age; lower education-level; cohabitation; having a partner; amphetamine-IDU; non-participation in OST; being HIV-negative and HCV-positive and among MWID: younger age; married; cohabitation; having a partner; amphetamine-IDU; non-participation in OST; history of custody, prison and being HIV-negative. WWID had higher NEP-retention levels compared to MWID over time. Being LTFU among WWID was associated with being HIV-negative and reporting injection risk behaviours and among MWID, younger age, non-participation in OST, being HIV-negative and having protected sex.

Conclusions: Despite better NEP compliance among WWID, high injection and sexual risk behaviours in both gender-subgroups, especially in intimate relationships, suggests ongoing HCV and HIV-infection risks. Subgroup-variation in the NEP continuum of care warrants more gender-disaggregated research and tailoring gender-sensitive services may improve prevention, health and retention outcomes.
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http://dx.doi.org/10.1016/j.drugpo.2020.103059DOI Listing
April 2021

Using interviews and observations in clinical practice to enhance authenticity in virtual patients for interprofessional education.

BMC Med Educ 2020 Nov 25;20(1):467. Epub 2020 Nov 25.

School of Health Sciences, Örebro University, Örebro, Sweden.

Background: Interprofessional collaboration is increasingly important in healthcare, but interprofessional education (IPE) faces challenges, such as different study programmes with varied schedules and campuses. These challenges can be met, in part, by using web-based virtual patients (VPs) as a tool in IPE. However, demands for relevant patient presentations and clinical practice increase when VPs are used by students from different programmes. The aim of this study was to improve the presentation of professional perspectives regarding nurses and physicians and their collaboration in order to increase the clinical authenticity of existing VPs.

Methods: Clinical observations were conducted to gain familiarity with the context. Semi-structured interviews were performed with individual nurses and physicians with experience of patients with leg ulcers. The interviews were recorded, transcribed and analysed using thematic analysis.

Results: The clinical observations exposed a lack of interprofessional collaboration in practice with regard to patients with leg ulcers. The interview analysis resulted in two themes: Clinical care and Organizational structure. The theme Clinical care included nursing with a holistic approach to the patient and awareness of the patient's well-being, including nutrition and home situation. The theme Organizational structure revealed a lack of teamwork in primary care. The interviewees stressed learning together and sharing responsibility, and they emphasised the importance of implementing interprofessional learning in the education of nurses and physicians in order to stimulate future teamwork. The VP should offer a broad medical history so that healthcare students are made aware of how a disease can affect the patient's social situation, and thereby illustrate the importance of interprofessional collaboration. The information should also be comprehensive and clear, leading to a diagnosis, so the student can gain clinical knowledge and build a foundation for discussion of treatment.

Conclusions: Interviews and observations in clinical practice can be used to enhance authenticity in VPs for interprofessional learning. A thorough look at authentic clinical environments can enrich and improve educational settings using VPs, and it can highlight the challenges students can encounter in clinical care of the patient and in an organisation with regard to interprofessional collaboration.
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http://dx.doi.org/10.1186/s12909-020-02379-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7687752PMC
November 2020

A qualitative study of facilitators and barriers to participate in a needle exchange program for women who inject drugs.

Harm Reduct J 2020 10 22;17(1):84. Epub 2020 Oct 22.

Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.

Background: Women who inject drugs (WWID) show higher levels of injecting risk behaviour compared to men, putting them at risk of contracting HIV and hepatitis C (HCV). Compared to men, WWID are also less present in harm reduction programs such as needle exchange programs (NEP). The aim of this study is to investigate reasons for, and barriers to, participation in NEP among WWID in Sweden, and to identify measures that could be taken to strengthen the program and increase participation among WWID.

Method: In-depth interviews (IDIs) were conducted with 20 WWID who had participated in the Stockholm NEP for at least six months and was over 18 years old. IDIs were audio recorded and transcribed et verbatim. Qualitative content analysis was used to identify themes.

Results: The need for sterile injection equipment was identified as the main driver to join and remain in the NEP program. Continuous participation in the NEP was further driven by easy access to a multitude of health-related services. The most valued service was the sexual and reproductive health services (SRHR), allowing participants to access contraceptives, cervical cancer screening and sexually transmitted infections testing (STI-testing). NEP staffs' respectful treatment of participants further contributed to program participation. However, participants also expressed a number of concerns around NEP participation, which created barriers to joining. These included losing custody or visitation rights to children, male partner jealousy and violence, unwillingness to spend time in the waiting area and fear of receiving positive HIV/HCV test results. Practical barriers included limited opening hours and travel distance to the NEP. To strengthen the program, most participants requested additional SRHR services. Most participants also proposed some form of "women only" access to the NEP, to strengthen the feeling of the NEP as a safe space.

Conclusion: This study identified factors that may increase uptake of NEP among WWID. Additional SRHR services and "women only" access are recommended to be implemented and evaluated as part of NEP. These findings may inform and improve the current scale-up of NEPs in Sweden to ensure equal access to services.
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http://dx.doi.org/10.1186/s12954-020-00425-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7579804PMC
October 2020

The greenhouse gas emission effects of rewetting drained peatlands and growing wetland plants for biogas fuel production.

J Environ Manage 2021 Jan 10;277:111391. Epub 2020 Oct 10.

Rydberg Laboratory of Applied Sciences, School of Business, Innovation and Sustainability, Halmstad University, Halmstad, Sweden.

Efforts to mitigate greenhouse gas (GHG) emissions are receiving increased attention among governmental and commercial actors. In recent years, the interest in paludiculture, i.e. the use of rewetted peatlands, has grown because of its potential to reduce GHG emissions by stopping soil decomposition. Moreover, cultivating wetland plants on rewetted peatlands for bioenergy production that replaces fossil fuels in the transport sector, can contribute to additional GHG emission reductions. In this study, an analysis of literature data was conducted to obtain data on GHG emissions (CO and CH) and biomass production from rewetted peatlands cultivated with two different wetland plant species: Phragmites australis (Pa) and Typha latifolia (Tl). In addition, a biogas experiment was carried out to investigate the biomethane yield of Pa and Tl biomass, and the reduction of global warming potential (GWP) by using biomethane as vehicle fuel. The results show that peatland rewetting can be an important measure to mitigate the GWP as it reduces GHG emissions from the soil, particularly on a 100-year timescale but also to some extent on a 20-year timescale. More specifically, rewetting of 1 km of peatland can result in a GWP reduction corresponding to the emissions from ±2600 average sized petrol cars annually. Growing Pa on rewetted peatlands reduces soil GHG emissions more than growing Tl, but Pa and Tl produced similar amounts of biomass and biomethane per land area. Our study concludes that Pa, because of a more pronounced GWP reduction, is the most suitable wetland plant to cultivate after peatland rewetting.
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http://dx.doi.org/10.1016/j.jenvman.2020.111391DOI Listing
January 2021

Patterns of Physical Activity Progression in Patients With COPD.

Arch Bronconeumol (Engl Ed) 2021 Mar 8;57(3):214-223. Epub 2020 Oct 8.

ISGlobal, Barcelona, Spain; Pompeu Fabra University (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address:

Introduction: Although mean physical activity in COPD patients declines by 400-500steps/day annually, it is unknown whether the natural progression is the same for all patients. We aimed to identify distinct physical activity progression patterns using a hypothesis-free approach and to assess their determinants.

Methods: We pooled data from two cohorts (usual care arm of Urban Training [NCT01897298] and PROactive initial validation [NCT01388218] studies) measuring physical activity at baseline and 12 months (Dynaport MoveMonitor). We identified clusters (patterns) of physical activity progression (based on levels and changes of steps/day) using k-means, and compared baseline sociodemographic, interpersonal, environmental, clinical and psychological characteristics across patterns.

Results: In 291 COPD patients (mean±SD 68±8 years, 81% male, FEV 59±19%) we identified three distinct physical activity progression patterns: Inactive (n=173 [59%], baseline: 4621±1757 steps/day, 12-month change (Δ): -487±1201 steps/day), ActiveImprovers (n=49 [17%], baseline: 7727±3275 steps/day, Δ:+3378±2203 steps/day) and ActiveDecliners (n=69 [24%], baseline: 11 267±3009 steps/day, Δ: -2217±2085 steps/day). After adjustment in a mixed multinomial logistic regression model using Active Decliners as reference pattern, a lower 6-min walking distance (RRR [95% CI] 0.94 [0.90-0.98] per 10m, P=.001) and a higher mMRC dyspnea score (1.71 [1.12-2.60] per 1 point, P=.012) were independently related with being Inactive. No baseline variable was independently associated with being an Active Improver.

Conclusions: The natural progression in physical activity over time in COPD patients is heterogeneous. While Inactive patients relate to worse scores for clinical COPD characteristics, Active Improvers and Decliners cannot be predicted at baseline.
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http://dx.doi.org/10.1016/j.arbres.2020.08.001DOI Listing
March 2021

COPDCompEx: A novel composite endpoint for COPD exacerbations to enable faster clinical development.

Respir Med 2020 11 28;173:106175. Epub 2020 Sep 28.

AstraZeneca, Early Respiratory & Immunology (R&I) Clinical Development, BioPharmaceuticals R&D, Gothenburg, Sweden. Electronic address:

Background: Frequency of moderate and severe chronic obstructive pulmonary disease exacerbations is an important endpoint in clinical trials, but makes them large and lengthy when powered to evaluate it. We aimed to develop a composite endpoint (COPDCompEx) that could predict treatment effect on exacerbations, enabling the design of shorter early phase clinical trials requiring fewer patients.

Methods: In this post hoc analysis, data from 20 randomized controlled trials were used to develop and test COPDCompEx. Diary events were tested against predefined threshold values for peak expiratory flow, reliever medication use, and symptoms. A COPDCompEx event was defined as first occurrence of a diary event, a moderate or severe exacerbation, or a study dropout. Ratios of event frequency, treatment effect and future trial sample size were compared between COPDCompEx and moderate and severe exacerbations.

Findings: At 3 months, the proportion of patients experiencing COPDCompEx events increased over 3-fold versus exacerbations alone. All components contributed to COPDCompEx event rate. Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.

Interpretation: COPDCompEx may be used to predict treatment effect on moderate and severe exacerbations of chronic obstructive pulmonary disease. This may enable the design of shorter Phase 2 clinical trials requiring fewer patients when compared with current exacerbation studies, with exacerbations as a key Phase 3 endpoint. This would, therefore, allow more efficient decision-making with reduced burden and risk to study participants.
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http://dx.doi.org/10.1016/j.rmed.2020.106175DOI Listing
November 2020

Treatment of age-related macular degeneration after cataract surgery: a study from the Swedish National Cataract and Macula Registers.

Acta Ophthalmol 2021 Feb 23;99(1):e124-e129. Epub 2020 Jun 23.

Department of Clinical Sciences/Ophthalmology, Umeå University Hospital, Umeå, Sweden.

Purpose: To characterize pre- and perioperative factors associated with treatment for wet age-related macular degeneration (wet AMD) after cataract surgery.

Methods: This register-based cohort study with data from the Swedish National Cataract Register (NCR) and the Swedish Macula Register (SMR) from 2010 to 2017 compared eyes with and without preoperative AMD that had undergone cataract surgery and was subsequently treated for wet AMD to eyes not treated within the study period. All first-eye surgeries registered in the NCR from 2010 to 2017 and matching eyes found in the SMR that had undergone treatment for wet AMD ≥ 1 year after the cataract procedure were included. Data for cataract surgery date, age and gender, use of a blue-blocking IOL, preoperative visual acuity, ocular comorbidities, posterior capsule rupture and date of AMD treatment initiation were extracted.

Results: The only independent factor associated with postoperative treatment of wet AMD in both groups was female gender (67.3% vs. 58.8%, p < 0.001 and 66.4% vs. 60.6%, p = 0.001, respectively). Older age was an independent factor in eyes without preoperative AMD (78.4 ± 6.5 vs. 73.4 ± 9.6 years, p < 0.001). A blue-blocking IOL appeared to decrease the likelihood of subsequent wet AMD treatment slightly but not statistically significant in eyes with preoperative AMD (52.7% vs. 56.8%, p = 0.110).

Conclusions: Some factors (female gender, high age) are associated with undergoing subsequent treatment for wet AMD to a higher extent. If the use of a blue-blocking IOL offers any protection from undergoing AMD treatment after cataract surgery, such an effect must be very small.
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http://dx.doi.org/10.1111/aos.14519DOI Listing
February 2021

Significant decrease in injection risk behaviours among participants in a needle exchange programme.

Infect Dis (Lond) 2020 05 19;52(5):336-346. Epub 2020 Feb 19.

Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.

Sharing of unsterile injection equipment contributes to transmission of hepatitis C virus (HCV), HIV and hepatitis B virus (HBV) among people who inject drugs (PWID) but is largely preventable through needle exchange programmes (NEP). Sweden has been one of the last countries in Europe to scale up access to NEP for PWID, who consequently have high prevalence rates of HCV and HIV. The aim of the study was to investigate demographic and drug-related determinants of injection risk behaviours, sharing of needle/syringe and paraphernalia, and patterns of change over time in subgroups of PWID participating in the Stockholm NEP. The Stockholm NEP started in 2013 as the first formal NEP in the region. A total of 2860 PWID were included in this prospective open cohort study. The association between demographic and drug-related determinants and injection risk behaviours were analysed at baseline and followed up at 6, 12, 24, 36 and 48 months post-enrolment. The following factors were associated with high levels of injection risk behaviours at inclusion: female gender, homelessness, low education level, younger age, amphetamine use, not in opioid substitution therapy (OST), being HIV negative and being HCV positive. We found an overall significant decrease in injection risk behaviours over time among participants. Not previously investigated in depth, we found that subgroups of participants varied in degrees of injection risk behaviour reduction over time and that women decreased injection risk behaviours faster than men. Enrolment in OST, HIV positive and age <25 years at inclusion were not associated with a decrease in injection risk behaviours over time. In this prospective cohort study over 4 years, we found that NEP participation was associated with a significant decrease in injection risk behaviours.
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http://dx.doi.org/10.1080/23744235.2020.1727002DOI Listing
May 2020

Tumor and nodal staging of colon cancer: accuracy of preoperative computed tomography at a Swedish high-volume center.

Acta Radiol Open 2019 Dec 30;8(12):2058460119888713. Epub 2019 Dec 30.

Department of Clinical Sciences Malmö, Lund University, Sweden.

Background: When deciding treatment options for patients with colon cancer, accurate staging is required. In Sweden, the main preoperative evaluation modality to determine tumor and nodal stage is computed tomography (CT).

Purpose: The aim of this study was to investigate how well the preoperative (CT-determined) clinical tumor and nodal stage (cTN) correlated with the postoperative histopathological stage (pTN). Another aim was to validate the tumor and nodal stage data in the Swedish Colorectal Cancer Registry (SCRCR).

Material And Methods: The SCRCR was used to identify patients with colon cancer, treated at a Swedish high-volume center during 2013-2016 (n = 974). Data were gathered from medical records regarding cTN and pTN stage, and predefined patient and tumor variables. The agreement between cTN and pTN was analyzed using kappa statistics.

Results: After excluding patients with either pre- or postoperative TN stage missing, 383 patients remained for further analyses. The analyses showed an agreement between cT and pT of κ: 0.27 and between cN and pN of κ: 0.21 (fair agreement). When comparing tumors with low (T1-3; N0) versus high risk (T4; N1-2), the kappa value was 0.19 (slight agreement). When comparing the SCRCR to medical records, 78% of completely staged tumors had been correctly reported.

Conclusion: The agreement between cTN and pTN was low in this study population, indicating a need for enhanced precision of the preoperative staging process. A high frequency of erroneous preoperative staging data in the SCRCR shows the need for further efforts of ensuring correct data transfers into the registry.
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http://dx.doi.org/10.1177/2058460119888713DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6939391PMC
December 2019

Prospective observational study in patients with obstructive lung disease: NOVELTY design.

ERJ Open Res 2019 Feb 1;5(1). Epub 2019 Feb 1.

School of Biological Sciences, University of Manchester, Manchester, UK.

Asthma and chronic obstructive pulmonary disease (COPD) have overlapping clinical features and share pathobiological mechanisms but are often considered distinct disorders. Prospective, observational studies across asthma, COPD and asthma-COPD overlap are limited. NOVELTY is a global, prospective observational 3-year study enrolling ∼12 000 patients ≥12 years of age from primary and specialist clinical practices in 19 countries (ClinicalTrials.gov identifier: NCT02760329). NOVELTY's primary objectives are to describe patient characteristics, treatment patterns and disease burden over time, and to identify phenotypes and molecular endotypes associated with differential outcomes over time in patients with a diagnosis/suspected diagnosis of asthma and/or COPD. NOVELTY aims to recruit real-world patients, unlike clinical studies with restrictive inclusion/exclusion criteria. Data collected at yearly intervals include clinical assessments, spirometry, biospecimens, patient-reported outcomes (PROs) and healthcare utilisation (HCU). PROs and HCU will also be collected 3-monthly internet/telephone. Data will be used to identify phenotypes and endotypes associated with different trajectories for symptom burden, clinical progression or remission and HCU. Results may allow patient classification across obstructive lung disease by clinical outcomes and biomarker profile, rather than by conventional diagnostic labels and severity categories. NOVELTY will provide a rich data source on obstructive lung disease, to help improve patient outcomes and aid novel drug development.
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http://dx.doi.org/10.1183/23120541.00036-2018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355976PMC
February 2019

Socioeconomic Status as a Determinant of Health Status Treatment Response in COPD Trials.

Chronic Obstr Pulm Dis 2017 Apr 1;4(2):150-158. Epub 2017 Apr 1.

Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom.

: Randomized controlled trials (RCTs) often recruit patients from low and high socioeconomic status (SES) countries, but little is known about the effect of SES on clinical outcomes, particularly patient-centered measures of symptomatic benefit. : Combined individual chronic obstructive pulmonary disease (COPD) patient data from the placebo and long-acting bronchodilator arms of 17 RCTs (from the COPD Biomarkers Qualification Consortium database) were analyzed. Health status was measured using the St George's Respiratory Questionnaire (SGRQ) (minimum clinically important difference [MCID]: 4 units). Trials were grouped into short-term (≤12 months) and medium-term (>12 months to 48 months). A participant's country of residence was categorized into Low/Medium or High SES using World Health Organization criteria. : Data from 19765 individuals (6109 Low/Medium SES) were available. Patients in Low/Medium SES countries had more severe disease at baseline. Improvement in SGRQ score with placebo was ≈2 units greater in Low/Medium than in High SES countries; at its greatest, the improvement from baseline exceeded the MCID in Low/Medium countries. This difference was maintained for at least 1 year. Improvement with bronchodilator was also greater in Low/Medium versus High SES countries; overall there was no evidence that the treatment effect versus placebo was different between countries of different SES status. : Participants in Low/Medium SES countries experienced significantly larger treatment effects, irrespective of treatment group (placebo and bronchodilator). Despite this, COPD patients in Low/Medium SES countries experienced a health status gain from long-acting bronchodilator treatment that is similar to that seen in High SES countries.
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http://dx.doi.org/10.15326/jcopdf.4.2.2017.0132DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5559114PMC
April 2017

St George's Respiratory Questionnaire Score Predicts Outcomes in Patients with COPD: Analysis of Individual Patient Data in the COPD Biomarkers Qualification Consortium Database.

Chronic Obstr Pulm Dis 2017 Mar 28;4(2):141-149. Epub 2017 Mar 28.

Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom.

We aimed to estimate the usefulness of a disease specific health status measure, the St George's Respiratory Questionnaire (SGRQ), to predict outcomes in patients with chronic obstructive pulmonary disease (COPD). Individual patient-data of 12043 patients from long-term randomized clinical trials (2-4 years' duration) in the COPD Biomarkers Qualification Consortium database were analyzed. The adverse COPD outcomes were: exacerbations of COPD, hospital admissions due to exacerbation and all-cause mortality. Cox proportional hazards regression was used to calculate adjusted hazard ratios (HR) and 95% confidence intervals (CIs) for quartiles of SGRQ scores at baseline and time to first event, and time from first to second event, where appropriate. The risk of adverse COPD outcomes increased with each increasing quartile of SGRQ score for all time to first event analyses. When comparing the lowest versus the highest quartile, the event risk (HRs [95% CIs]) increased by 40% for exacerbations (1.40 [1.29, 1.51]); 2-fold for hospital admissions (2.01 [1.78, 2.28]) and more than 2-fold for all-cause mortality (2.30 [1.91, 2.78]). For second event analyses in a subset of eligible patients, these trends persisted albeit with reduced risk estimates for exacerbations. Among patients with COPD, health status measured by a SGRQ score predicted exacerbations of COPD, hospital admissions due to exacerbations and their recurrence and death after adjustment. These data support the rationale for a health status measure use as a drug development tool and suggest that a health status measure may also have a role in risk assessment for COPD patients in routine medical care.
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http://dx.doi.org/10.15326/jcopdf.4.2.2017.0131DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5559113PMC
March 2017

Baseline Severity as Predictor of Change in St George's Respiratory Questionnaire Scores in Trials of Long-acting Bronchodilators with COPD Patients.

Chronic Obstr Pulm Dis 2017 Mar 21;4(2):132-140. Epub 2017 Mar 21.

Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom.

In trials oflong-acting bronchodilators, health status is an important trial outcome, however the influence of baseline severity on response measured by St George's Respiratory Questionnaire (SGRQ) is not known. We have compared SGRQ changes between patients with chronic obstructive pulmonary disease (COPD) of mild-moderate severity or dyspnea (Global initiative for chronic Obstructive Lung disease [GOLD] grades 1 and 2; modified Medical Research Council [mMRC] grades 1 and 2) to those with severe-very severe severity or dyspnea (GOLD grades 3 and 4; mMRC grades 3 and 4). Combined individual patient data from the COPD Biomarkers Qualification Consortium database (trials of long-acting bronchodilators) were used comprising of patients from short-term (≤1-year duration; n=10802) and medium-term (2-4 years' duration; n=8963) studies. A repeated measures analysis of variance (ANOVA) was used to determine the effects of baseline severity (GOLD/mMRC) on SGRQ response to treatment. All treatment arms were combined. In short-term studies, milder patients showed a greater response than those with more severe disease in terms of GOLD grade (partial Eta = 0.03, < 0.0001) and mMRC grade (partial Eta = 0.05, < 0.0001). Similar results were seen in the medium-term studies (partial Eta = 0.02, < 0.0001; mMRC: partial Eta = 0.05, < 0.0001,). Patients with less severe airflow limitation and less severe dyspnea showed larger improvements in SGRQ score than more severely obstructed or dyspneic patients. Although these severity influences are small (2%-5% of the variance in SGRQ score), they do suggest that pre-specified separate analyses are warranted to test for differences in response, based on baseline severity.
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http://dx.doi.org/10.15326/jcopdf.4.2.2017.0129DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5559112PMC
March 2017

Responder Analyses for Treatment Effects in COPD Using the St George's Respiratory Questionnaire.

Chronic Obstr Pulm Dis 2017 Mar 2;4(2):124-131. Epub 2017 Mar 2.

Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom.

: Patient-reported outcomes data in clinical trials are usually reported as mean values, interpreted in comparison to a minimum clinically important difference (MCID) and ignoring the possibility of a sizable proportion of patients experiencing a worthwhile benefit when the majority did not. This analysis tested the reliability of calculated responder rates (from chronic obstructive pulmonary disease [COPD] patients) with the St George's Respiratory Questionnaire (SGRQ) using a range of responder cut-points above and below the MCID (4 units). : Individual patient data (i.e., data from long-acting bronchodilator [LAB] and inhaled corticosteroids [ICS]/long-acting beta2-agonist [LABA] randomized clinical studies) in the COPD Biomarker Qualification Consortium database were used: short-term (≤1-year duration; 14,814 patients,) and medium-term (2-4 years; 12,043 patients). Responder rates versus placebo across SGRQ score change thresholds ranging from -1.5 to -8.0 were tested; differences were expressed as the odds ratio (OR) of a patient exceeding the threshold versus no change or deterioration. : The ORs measuring benefit of active treatment were similar across thresholds in short-term studies (LAB, ORs 1.40-1.42; LABA/ICS, 1.50-1.56) and medium-term LAB studies (ORs 1.34-1.43), whereas ORs in medium-term studies with LABA/ICS intervention showed a trend for higher response rates at higher values of threshold cut-points (1.64-1.79). In short-term studies, different thresholds had little effect on the OR between active drugs versus a trend for lower ORs with lower thresholds in medium-term studies. : The OR for a treatment effect compared with placebo appears consistent across a range of responder cut-points. In medium-term trials, the treatment difference between active drugs suggests that use of a lower threshold would not increase the odds of observing a measured treatment difference.
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http://dx.doi.org/10.15326/jcopdf.4.2.2017.0130DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5559111PMC
March 2017

The COPD Biomarkers Qualification Consortium Database: Baseline Characteristics of the St George's Respiratory Questionnaire Dataset.

Chronic Obstr Pulm Dis 2017 Mar 13;4(2):112-123. Epub 2017 Mar 13.

Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom.

The COPD Biomarkers Qualification Consortium (CBQC) is a public-private partnership formed in 2010 with a goal of qualifying biomarkers and clinical assessment tools for use in clinical or nonclinical decision-making and particularly within the regulatory context. The St George's Respiratory Questionnaire (SGRQ) is a measure of health-related quality of life widely used in clinical research. The aim of the CBQC working group on SGRQ was to construct an individual patient level database of clinical trial data that included the SGRQ, to use this to confirm the reliability and validity of the SGRQ as an outcome measure of health status, and investigate its use as a predictor of future events (exacerbations and mortality). This manuscript describes the formulation of the CBQC database and presents the baseline demographic and clinical characteristics of the integrated SGRQ database overall, and by study type (short-term [≤1 year], medium-term [2-4 years] and observational studies). Distribution of baseline SGRQ scores varied little by demographic determinants except for income region in the observational data set (low-middle income countries +10 units compared with high income, <0.0001) and this observation held across studies. SGRQ scores increased with increasing modified Medical Research Council dyspnea scores (mean differences ranged 6.9-17.9 units) and with increasing airflow limitations (Global initiative for chronic Obstructive Lung Disease grades 1 to 4; differences ranged 4.5-16.1 units), consistent across study types. As a method of cross-sectional comparison, the SGRQ appears to be relatively free of bias from demographic factors although care should be taken when making cross sectional comparisons of scores between patients in countries at different levels of socio-economic development/.
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http://dx.doi.org/10.15326/jcopdf.4.2.2017.0128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5559110PMC
March 2017

Treatment for neovascular age-related macular degeneration in Sweden: outcomes at seven years in the Swedish Macula Register.

Acta Ophthalmol 2017 Dec 21;95(8):787-795. Epub 2017 Aug 21.

Department of Ophthalmology, Lund University, Lund, Sweden.

Purpose: To present Swedish Macula Register (SMR) data regarding treatment of neovascular age-related macular degeneration (AMD) in clinical practice since 2008.

Methods: A retrospective register-based study was conducted. Evaluation of baseline demographics, visual outcome and number of injections during this period is presented.

Results: Mean age at diagnosis was 79 ± (SD) 8 years; 65% were female. The proportion of patients with <2 months' duration of symptoms increased from 26% in 2008 to 41% in 2014 (p = 0.001). Mean visual acuity (VA) at baseline increased from 54.3 ± 15.0 early treatment diabetic retinopathy study (ETDRS) letters in 2008 to 57.8 ± 15.6 letters in 2014 (CI 2.6; 4.3; p < 0.001). Mean VA after 1 year of treatment increased from 57.8 ± 17.7 ETDRS letters for patients who started the treatment in 2008 to 62.8 ± 16.4 ETDRS letters in patients starting treatment in 2014 (CI 2.67; 4.64; p < 0.001). During all study years, the proportion of patients with an improvement in VA of between 5 and 15 letters was around 30%, while 14% had VA improvement of more than 15 letters. The mean number of injections during the first treatment year increased from 4.3 ± 1.9 in 2008 to 5.9 ± 2.9 in 2014 (CI 1.40; 1.67; p < 0.001). Seven-year follow-up of 322 eyes showed a mean change of -1 letters from baseline, with a mean of 21 injections for the entire period.

Conclusion: The duration of symptoms before treatment decreased, while VA at baseline and after 1 year of treatment increased over the years and so did the number of injections. Long-term follow-up demonstrated stable VA.
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http://dx.doi.org/10.1111/aos.13539DOI Listing
December 2017

Risk behaviour determinants among people who inject drugs in Stockholm, Sweden over a 10-year period, from 2002 to 2012.

Harm Reduct J 2017 08 16;14(1):57. Epub 2017 Aug 16.

Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.

Background: People who inject drugs (PWID) frequently engage in injection risk behaviours exposing them to blood-borne infections. Understanding the underlying causes that drive various types and levels of risk behaviours is important to better target preventive interventions.

Methods: A total of 2150 PWID in Swedish remand prisons were interviewed between 2002 and 2012. Questions on socio-demographic and drug-related variables were asked in relation to the following outcomes: Having shared injection drug solution and having lent out or having received already used drug injection equipment within a 12 month recall period.

Results: Women shared solutions more than men (odds ratio (OR) 1.51, 95% confidence interval (CI) 1.03; 2.21). Those who had begun to inject drugs before age 17 had a higher risk (OR 1.43, 95% CI 0.99; 2.08) of having received used equipment compared to 17-19 year olds. Amphetamine-injectors shared solutions more than those injecting heroin (OR 2.43, 95% CI 1.64; 3.62). A housing contract lowered the risk of unsafe injection by 37-59% compared to being homeless.

Conclusions: Women, early drug debut, amphetamine users and homeless people had a significantly higher level of injection risk behaviour and need special attention and tailored prevention to successfully combat hepatitis C and HIV transmission among PWID.

Trial Registration: ClinicalTrials.gov Identifier, NCT02234167.
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http://dx.doi.org/10.1186/s12954-017-0184-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5559856PMC
August 2017

A cross-sectional assessment of the burden of COPD symptoms in the US and Europe using the National Health and Wellness Survey.

Int J Chron Obstruct Pulmon Dis 2017 7;12:529-539. Epub 2017 Feb 7.

AstraZeneca Gothenburg, Mölndal, Sweden.

Introduction: Past research has suggested significant relationships between symptoms and health outcomes among patients with COPD. However, these studies have generally focused on a broad COPD sample and may have included those not receiving proper treatment. As a result, the aim of this study was to document the burden of COPD symptoms among those who are currently treated with the standard-of-care (SOC) medications in both the US and Western Europe.

Methods: Data from the 2013 US (N=75,000) and 2011 (N=57,512)/2013 (N=62,000) European (France, Germany, Italy, Spain, and UK; 5EU) National Health and Wellness Survey (NHWS) were used. The NHWS is a health survey administered to a demographically representative sample of the adult population in each country. A total of 1,666 and 2,006 patients with self-reported physician diagnosis of COPD in the 5EU and US, respectively, were being treated with the appropriate SOC (based on self-reported medication use) and were included in the analyses. Symptoms (eg, dyspnea, coughing, wheezing) were reported descriptively and summed to create a symptom score (with higher score indicating more frequent symptoms). The relationships between the symptom score and patient outcomes (eg, health status using the Short Form-36 version 2 [SF-36v2], work productivity and activity impairment [WPAI], and self-reported health care resource use) were explored using regression modeling.

Results: Nearly all patients (99.7% and 99.8% in the 5EU and US, respectively) reported experiencing symptoms and >80% reported experiencing at least one symptom "often". Increasing symptom scores were associated with poorer health status (unstandardized beta [] =-0.87 and -0.78 for mental component summary and physical component summary, respectively, in the US and =-0.67 and -0.79 in the 5EU, respectively; all <0.05). Increasing symptom scores were also associated with greater work impairment ( =0.09 and 0.06 for the US and 5EU, respectively), activity impairment ( =0.05 and 0.06, respectively), and health care resource utilization (eg, hospitalizations: =0.05 and 0.06, respectively) (all <0.05). Approximately 70% of patients reported some level of non-adherence. Greater non-adherence was significantly associated with more frequent symptoms, poorer health status, and greater work impairment and health care resource use (all <0.05).

Conclusion: Patients with COPD who are using the appropriate SOC still experience symptoms, which have a significant effect on both humanistic and economic outcomes.
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http://dx.doi.org/10.2147/COPD.S114085DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5304979PMC
August 2017

A cross-sectional assessment of the prevalence and burden of mild asthma in urban China using the 2010, 2012, and 2013 China National Health and Wellness Surveys.

J Asthma 2017 Aug 21;54(6):632-643. Epub 2016 Dec 21.

c Medical Affairs China, AstraZeneca , Shanghai , China.

Objective: To estimate the prevalence of mild asthma in urban China and to measure the association between asthma severity and quality of life (QOL), work productivity, and healthcare resource use.

Methods: Data were from the China National Health and Wellness Surveys (NHWS) conducted between 2010 and 2013 (N = 59,935), Internet-based surveys of adults in urban China. Patients were categorized by asthma severity according to self-report and Global Initiative for Asthma (GINA2014) guidelines via self-reported medication use (mild [GINA 1-2] vs moderate/severe [GINA 3-4]). Propensity scores were used to identify matched controls without asthma. These three groups (mild vs. moderate/severe vs. matched control) were compared with respect to QOL (revised Short Form-12/36), work productivity (WPAI questionnaire), and healthcare use using generalized linear models.

Results: 1,191 respondents reported an asthma diagnosis (1.99%). Then 455 (0.77% and 76.86% of the total sample and asthma sample which could be categorized based on GINA2014 guidelines, respectively) and 897 (1.50% and 75.31% of the total and asthma sample, respectively) had mild asthma based on GINA2014 guidelines and self-report, respectively. Compared with matched controls, mild patients based on GINA2014 guidelines reported worse QOL (Physical Component Summary = 44.67 vs. 48.97), more overall work impairment (54.51% vs. 34.35%), and more all-cause emergency room visits in the past 6 months (1.95 vs. 0.63 visits) (all p <.05). Similar results were observed using self-reported severity.

Conclusions: Most patients with asthma in the China NHWS are mild according to either definition. Asthma patients experience significant burden to QOL, work productivity, activity impairment, and healthcare resource use.
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http://dx.doi.org/10.1080/02770903.2016.1255750DOI Listing
August 2017

Reduced occurrence of severe visual impairment after introduction of anti-Vascular Endothelial Growth Factor in wet age-related macular degeneration - a population- and register-based study from northern Sweden.

Acta Ophthalmol 2016 Nov 22;94(7):646-651. Epub 2016 Aug 22.

IKVL Institution of Clinical Science, Ophthalmology, Lund University, Lund, Sweden.

Purpose: To study the occurrence of severe visual impairment (SVI) and treatment outcome at 12 months in patients treated for wet age-related macular degeneration (AMD) by use of data from the Swedish Macula Register (SMR) and referrals to the regional low vision clinics in five northern counties.

Methods: Referrals to low vision clinics during 2005, 2009 and 2013 and treatment outcome at 12 months from the SMR database from 2008 until 2013 in patients >65 years of age in five northern counties were included in the survey.

Results: The rate of referral due to AMD was significantly reduced during the time period (-48%; p < 0.001). At 12 months, a significant slight mean improvement in logMAR visual acuity (VA) was observed (-0.01, SD 0.37; p < 0.001) after a mean of 5.0 ± 2.3 anti-vascular endothelial growth factor (VEGF)-injections were administered. Age and low baseline VA was associated with less favourable visual outcome (p < 0.001).

Conclusion: Referral rate to low vision clinic is a valuable tool for estimating occurrence of SVI and fell between the years 2005 until 2013. Data from the SMR showed improvement in visual acuity on the whole, but also identified patients at high risk for developing SVI during anti-VEGF-treatment.
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http://dx.doi.org/10.1111/aos.13187DOI Listing
November 2016

Development of the chronic obstructive pulmonary disease morning symptom diary (COPD-MSD).

Health Qual Life Outcomes 2016 Jul 16;14(1):104. Epub 2016 Jul 16.

Evidera, Bethesda, Maryland, USA.

Background: The morning tends to be the most difficult time of day for many patients with chronic obstructive pulmonary disease (COPD) when symptoms can limit one's ability to perform even simple activities. Morning symptoms have been linked to higher levels of work absenteeism, thereby increasing the already substantial economic burden associated with COPD. A validated patient-reported outcome (PRO) instrument designed to capture morning symptoms will allow for a more comprehensive approach to the evaluation of treatment benefit in COPD clinical trials.

Methods: A qualitative interview study was conducted among a sample of symptomatic adults with COPD. Concept elicitation interviews (n = 35) were conducted to identify COPD morning symptoms, followed by cognitive interviews (n = 21) to ensure patient comprehension of the items, instructions and response options of the draft COPD Morning Symptom Diary (COPD-MSD). All interview transcript data were coded using ATLAS.ti software for content analysis.

Results: Mean age of the concept elicitation and cognitive interview sample was 65.0 years (±7.5) and 62.3 years (±8.3), respectively. The study sample represented the full range of COPD severity (Global Initiative for Chronic Lung Disease [GOLD] classifications I-IV) and included a mix of racial backgrounds, employment status and educational achievement. During the concept elicitation interviews, the three most frequently reported morning symptoms were shortness of breath (n = 35/35; 100 %), phlegm/mucus (n = 31/35; 88.6 %), and cough (n = 30/35; 85.7 %). A group of clinical and instrument development experts convened to review the concept elicitation data and develop the initial 32-item draft COPD-MSD. Cognitive interviews indicated subjects found the draft COPD-MSD to be comprehensive, clear, and easy to understand. The COPD-MSD underwent minor editorial revisions and streamlining based on cognitive interviews and input from the experts to yield the final 19-item daily diary.

Conclusions: This study supports the content validity of the new COPD-MSD and positions the diary for quantitative psychometric testing.
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http://dx.doi.org/10.1186/s12955-016-0506-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947344PMC
July 2016

Depression symptoms reduce physical activity in COPD patients: a prospective multicenter study.

Int J Chron Obstruct Pulmon Dis 2016 10;11:1287-95. Epub 2016 Jun 10.

ISGlobal, Centre for Research in Environmental Epidemiology (CREAL), Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBEREpidemiología y Salud Pública (CIBERESP), Barcelona, Spain.

Background: The role of anxiety and depression in the physical activity (PA) of patients with COPD is controversial. We prospectively assessed the effect of symptoms of anxiety and depression on PA in COPD patients.

Methods: We evaluated anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), PA (Dynaport(®) accelerometer), and other relevant characteristics in 220 COPD patients from five European countries at baseline and at 6 and 12 months of follow-up. HADS score was categorized as: no symptoms (score 0-7), suggested (8-10), and probable (>11) anxiety or depression. We estimated the association between anxiety and depression at t (baseline and 6 months) and PA at t+1 (6 and 12 months) using regression models with a repeated measures approach.

Results: Patients had a mean (standard deviation) age of 67 (8) years, forced expiratory volume in 1 second 57 (20)% predicted. At baseline, the prevalence of probable anxiety and depression was 10% and 5%, respectively. In multivariable models adjusted by confounders and previous PA, patients performed 81 fewer steps/day (95% confidence interval, -149 to -12, P=0.02) per extra point in HADS-depression score. HADS-anxiety symptoms were not associated with PA.

Conclusion: In COPD patients, symptoms of depression are prospectively associated with a measurable reduction in PA 6 months later.
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http://dx.doi.org/10.2147/COPD.S101459DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910613PMC
August 2017

Asthma-chronic obstructive pulmonary disease overlap syndrome in the urban Chinese population: prevalence and disease burden using the 2010, 2012, and 2013 China National Health and Wellness Surveys.

Int J Chron Obstruct Pulmon Dis 2016 9;11:1139-50. Epub 2016 Jun 9.

Department of Medical Affairs China, AstraZeneca, Shanghai, People's Republic of China.

Background: Research has suggested a significant burden for patients with asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS). However, few studies have studied this population in the People's Republic of China, a region in the midst of rapid epidemiological change with respect to respiratory disease. The aim of this study was to assess the prevalence of ACOS and its association with patient outcomes in urban China.

Methods: Data from the 2010, 2012, and 2013 China National Health and Wellness Survey, an Internet-based survey of adults in urban China, were used (N=59,935). Respondents were categorized into one of four groups based on self-reported physician diagnoses: ACOS, asthma only, COPD only, or control (ie, no asthma or COPD). A propensity score matching procedure was conducted to cull the control group into a subgroup (ie, matched controls) who resembled patients with ACOS, asthma only, and COPD only. These four groups (ACOS, asthma only, COPD only, matched controls) were then compared with respect to health status (Short Form-12 version 2/Short Form-36 version 2), work productivity, and health care resource use using generalized linear models.

Results: Patients with ACOS (N=366) comprised 0.61% of the adult population, 30.73% of the asthma population, and 18.60% of the COPD population in the People's Republic of China. Patients with ACOS reported significantly worse health status (eg, health utilities =0.63, 0.66, 0.63, and 0.69 for ACOS, COPD only, asthma only, and matched controls, respectively) and significantly greater work impairment (eg, overall work impairment =43.65%, 35.19%, 48.55%, and 29.80%, respectively) and health care resource use (eg, physician visits in the past 6 months =5.13, 3.84, 4.65, and 2.39, respectively) compared with matched controls and patients with COPD only. Few significant differences were observed between patients with ACOS and asthma only.

Conclusion: Patients with ACOS have a greater comorbidity burden and significantly worse health outcomes compared with COPD only patients and matched controls. Better management of these patients may help to improve their outcomes.
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http://dx.doi.org/10.2147/COPD.S103873DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4907484PMC
August 2017
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