Published in 2021

Novel quantitative digital image analysis methodology for assessment of inflammatory changes in MRI data in a post-hoc analysis of data acquired from a phase IIb study of baricitinib in patients with active rheumatoid arthritis

Boesen, M., Beattie, S. D., Schlichting, D. E. & Kubassova, O., okt. 2021, I: European Journal of Radiology. 143, s. 109877 109877.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Purpose: To evaluate a novel quantitative methodology to assess inflammatory changes in magnetic resonance imaging (MRI) data from patients with rheumatoid arthritis (RA) and the impact of image quality on imaging outcomes compared to the RA Magnetic Resonance Imaging Score (RAMRIS). Methods: Three-dimensional, T1-weighted, fat-suppressed MRI sequences of the hand/wrist before and after intravenous Gadolinium contrast from patients with RA in a placebo-controlled clinical trial (NCT01185353) were re-evaluated post hoc. The methodology was integrated into proprietary software (DYNAMIKA®) and assessed inflammation through pixelated measurements of the contrast-enhancing (inflammatory) volume. A semi-automatic approach outlined contrast-enhancing synovial tissue in the wrist and second to fifth metacarpophalangeal joints with a rough region of interest (ROI); quantitative imaging biomarkers were generated by means of quantitative total volume of inflammation and quantitative degree of inflammation relative to the signal in a 1 cm in diameter ROI in the center of the thenar or lumbrical muscle for internal reference. The time from Gadolinium injection to finalization of the post-contrast images was calculated from the images’ Digital Imaging and Communications in Medicine header. An experienced reader graded image quality as poor, acceptable, or good. Results: Results from this quantitative methodology, especially when excluding images with poor quality scores (14–32%), provided a more pronounced and monotonically increasing dose-response than the original RAMRIS results on synovitis and osteitis. Conclusions: This computer-aided quantitative scoring method provided continuous measures of inflammatory changes relative to muscle and may be more sensitive and interpretable concerning dose/response separation between RA treatment groups.

Originalsprog Engelsk
Artikelnummer 109877
Tidsskrift European Journal of Radiology
Vol/bind 143
Sider (fra-til) 109877
ISSN 0720-048X
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Funding Information:
Medical writing support was provided by Shannon E. Gardell of Evidera | PPD and funded by Eli Lilly and Company.

Funding Information:
Medical writing support was provided by Shannon E. Gardell of Evidera | PPD and funded by Eli Lilly and Company. Funding for this study was provided by Eli Lilly and Company, which was involved in the study design, data collection, data analysis, and preparation of the manuscript. Eli Lilly provides access to all individual participant data collected during the trial, after anonymization, except for pharmacokinetic or genetic data. Data are available upon request six months after the indication studied has been approved in the United States and European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data-sharing environment. For details on submitting a request, see the instructions provided atwww.vivli.org.

Publisher Copyright:
© 2021 Eli Lilly and Company

Nursing Implication of People Treated by Radical Cystectomy Postsurgery and Rehabilitation

Lauridsen, S. V., feb. 2021, I: Seminars in Oncology Nursing. 37, 1, 151110.

Publikation: Bidrag til tidsskriftReviewpeer review

OBJECTIVE: The purpose of this paper is to summarize existing evidence about nursing interventions to selected symptoms experienced by patients undergoing radical cystectomy (RC) to maintain or return to their daily life activities.

DATA SOURCES: A non-systematic narrative review was conducted. A search in PubMed and CINAHL was conducted eliciting evidence about frequent symptoms experienced after RC. The following search terms were used: radical cystectomy and/or nursing interventions, pain, distress, fatigue, urinary dysfunction, sexual dysfunction, loss of appetite, sleep disturbance, and enhanced recovery after surgery (ERAS).

CONCLUSION: Evidence in the ERAS pathway is still lacking regarding the effect of preoperative education and counseling of the patient and the most difficult part to implement is related to preoperative optimization of the patient such as lifestyle changes. Most nursing interventions to alleviate symptoms in the rehabilitation period after RC are still practice based.

IMPLICATIONS FOR NURSING PRACTICE: Priority should be given to implementation of the ERAS protocol. To improve the management of symptoms experienced by patients in the RC rehabilitation period it is essential that validated screening tools to identify the symptoms be used. Accepted and effective strategies for treating the individual symptoms should be initiated and clear treatment outcomes should be defined. Urology nurse researchers should investigate the concept of symptom clusters to clarify whether there are more efficient methods to identify symptoms or symptom clusters and if so would the use of symptom clusters knowledge improve patient care.

Originalsprog Engelsk
Artikelnummer 151110
Tidsskrift Seminars in Oncology Nursing
Vol/bind 37
Udgave nummer 1
ISSN 0749-2081
DOI
Status Udgivet - feb. 2021

Bibliografisk note

Copyright © 2020 Elsevier Inc. All rights reserved.

Occupational skin disease in physicians: A review of the literature

Henning, M. A. S., Jemec, G. B. & Ibler, K. S., 1 jan. 2021, I: Annals of Work Exposures and Health. 65, 1, s. 11-25 15 s.

Publikation: Bidrag til tidsskriftReviewpeer review

BACKGROUND: The ABLE intervention was developed to enhance the ability to perform activities of daily living (ADL) tasks among persons living with chronic conditions. ABLE is a generic, home-based, individualised, 8-week occupational therapy intervention program, developed to be delivered in Danish municipalities. In a previous study, the feasibility of ABLE was evaluated in terms of content and delivery. In this pilot study, the remaining feasibility aspects of a randomised controlled trial including (i) trial procedures (recruitment and retention), (ii) randomisation, (iii) adherence to program, (iv) feasibility of additional outcome measurements, and (iv) access to information on usual occupational therapy were evaluated.

METHODS: The study was conducted in a Danish municipality, using a two-armed parallel randomised controlled design, planning a recruitment strategy including 20 persons living with one/more chronic conditions and experiencing problems performing ADL. The following progression criteria were used to determine if a future full-scale randomised controlled trial was feasible: (i) recruitment (50% met the eligibility criteria) and retention (80%), (ii) randomisation (80% accepted randomisation, procedure was executed as planned), (iii) adherence to program (100% followed the treatment protocol), (iv) outcome measurements (80% of the participants delivered relevantly and fully answered questionnaires), and (v) usual occupational therapy (extraction of needed information was successful).

RESULTS: Due to the COVID-19 pandemic, the study was truncated resulting in limited but sufficient data to answer most of the study questions. (i) Eighteen of 37 eligible persons (48.6%) were recruited; of those treated (n = 6), all remained (100%); (ii) 18 accepted randomisation (100%), and procedure was effective; (iii) ABLE was delivered with adherence (100%); (iv) 92.3-100% of the participants gave relevant and complete answers in two of three questionnaires; and (v) needed information on usual occupational therapy was extractable in seven of nine aspects.

CONCLUSIONS: Proceeding to full-scale trial is recommendable; however, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual occupational therapy are needed.

TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (Identifier: NCT04295837 ) on December 5th, 2019. Retrospectively registered.

Originalsprog Engelsk
Artikelnummer 122
Tidsskrift Pilot and Feasibility Studies
Vol/bind 7
Udgave nummer 1
Sider (fra-til) 122
ISSN 2055-5784
DOI
Status Udgivet - 11 jun. 2021

Older age, smoking, tooth loss and denture-wearing but neither xerostomia nor salivary gland hypofunction are associated with low intakes of fruit and vegetables in older Danish adults

Pedersen, A. M. L., Dynesen, A. W. & Heitmann, B. L., 17 jul. 2021, I: Journal of Nutritional Science. 10, s. e47

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Xerostomia and salivary gland hypofunction are prevalent conditions in older people and may adversely influence the intake of certain foods, notably fruit and vegetables. Here, we aimed to investigate whether xerostomia and salivary gland hypofunction were associated with a lower intake of fruit and vegetables. The study included 621 community-dwelling adults, mean age 75⋅2 ± 6⋅4 years, 58⋅9 % female, who had participated in the Copenhagen City Heart Study follow-up, and undergone interviews regarding food intake (preceding month), oral and general health (xerostomia, taste alterations, diseases, medication, alcohol consumption and smoking), clinical oral examination and measurements of unstimulated and chewing-stimulated whole saliva flow rates. The average total energy intake (8⋅4 ± 2⋅7 MJ) and protein energy percentage (14⋅8 ± 3⋅1 %) were slightly below recommendations. The average fruit (234⋅7 ± 201⋅2 g/d) and vegetables (317⋅3 ± 157⋅4 g/d) intakes were within recommendations. Xerostomia and hyposalivation were more prevalent in women than in men (16⋅4 v. 7⋅1 %, P < 0⋅001 and 40⋅7 v. 27⋅5 %, P < 0⋅001). Multiple linear regression analyses revealed that older age (β -0⋅009, se 0⋅003, P = 0⋅005), smoking (β -0⋅212, se 0⋅060, P = 0⋅0005) and wearing complete dentures/being partially or fully edentulous (β -0⋅141, se 0⋅048, P = 0⋅003), but neither xerostomia nor salivary flow rates were associated with an inadequate fruit and vegetable intake, after adjustment for covariates. Older age, smoking, tooth loss and denture-wearing were stronger determinants of low fruit and vegetable intakes than xerostomia and salivary hypofunction supporting the importance of dietary counselling and maintenance of oral health and an adequate masticatory performance.

Originalsprog Engelsk
Tidsskrift Journal of Nutritional Science
Vol/bind 10
Sider (fra-til) e47
ISSN 0029-6651
DOI
Status Udgivet - 17 jul. 2021

OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

Nielsen, S. M., Boers, M., de Wit, M., Shea, B., van der Windt, D. A., Reeves, B. C., Beaton, D., Alten, R., Toupin April, K., Boonen, A., Escorpizo, R., Flurey, C., Furst, D. E., Guillemin, F., Leong, A., Pohl, C., Rasmussen, M. U., Singh, J. A., Smolen, J. S., Strand, V., & 8 flereVerstappen, S. M. M., Voshaar, M., Woodworth, T. G., Ellingsen, T., March, L., Wells, G. A., Tugwell, P. & Christensen, R., jun. 2021, I: Seminars in Arthritis and Rheumatism. 51, 3, s. 601-606 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: To develop an operational definition of contextual factors (CF) [1].

METHODS: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.

RESULTS: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.

CONCLUSION: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 3
Sider (fra-til) 601-606
Antal sider 6
ISSN 0049-0172
DOI
Status Udgivet - jun. 2021

OMERACT Filter 2.1 instrument selection for physical function domain in psoriatic arthritis: Provisional endorsement for HAQ-DI and SF-36 PF

Leung, Y-Y., Orbai, A-M., Hojgaard, P., Holland, R., Mathew, A. J., Goel, N., Chau, J., Tillett, W., Lindsay, C., Ogdie, A., Coates, L. C., Gladman, D. D., Christensen, R., Mease, P. & Strand, V., okt. 2021, I: Seminars in Arthritis and Rheumatism. 51, 5, s. 1117-1124 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: Physical function is one of the core domains to be measured in all trials in psoriatic arthritis (PsA). We aimed to evaluate two instruments for physical function in PsA: The Health Assessment Questionnaire-disability index (HAQ-DI) and the physical functioning subscale of the Medical Outcome Survey Short-Form 36 items (SF-36 PF).

METHODS: We followed guidelines set out by the OMERACT Filter 2.1. A working group was formed to evaluate each instrument for domain match and feasibility to reach consensus. Two systematic literature reviews (SLRs) were conducted to identify the relevant articles supporting measurement properties of both instruments. Five additional measurement properties were appraised: construct validity, test-retest reliability, longitudinal construct validity, clinical trial discrimination, and threshold of meaning. New evidence was synthesized to fill the gap. Data were presented to the OMERACT technical advisory group (TAG) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) community for endorsement.

RESULTS: The results for seven measurement properties for HAQ-DI and SF-36 PF were presented in Summary of Measurement Property (SOMP) tables. The working group proposed "Provisional Endorsement" for both instruments. The body of evidence was approved by the OMERACT TAG. In two Delphi exercises among GRAPPA members, HAQ-DI received 93.9% and 97.5% endorsement votes, while that for SF-36 PF were 86.7% and 77.3%.

CONCLUSION: Both HAQ-DI and SF-36 PF were provisionally endorsed for the measurement of physical function in PsA trials, using the OMERACT Filter 2.1.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 5
Sider (fra-til) 1117-1124
Antal sider 8
ISSN 0049-0172
DOI
Status Udgivet - okt. 2021

Bibliografisk note

Copyright © 2021 Elsevier Inc. All rights reserved.

One year of Football Fitness improves L1–L4 BMD, postural balance, and muscle strength in women treated for breast cancer

Uth, J., Fristrup, B., Sørensen, V., Helge, E. W., Christensen, M. K., Kjærgaard, J. B., Møller, T. K., Helge, J. W., Jørgensen, N. R., Rørth, M., Vadstrup, E. S. & Krustrup, P., 2021, I: Scandinavian Journal of Medicine and Science in Sports.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: The effects of lifestyle interventions in persons with type 2 diabetes (T2D) on health-related quality of life (HRQoL) and subjective well-being are ambiguous, and no studies have explored the effect of exercise interventions that meet or exceed current recommended exercise levels. We investigated whether a 1-year intensive lifestyle intervention is superior in improving HRQoL compared with standard care in T2D persons.

RESEARCH DESIGN AND METHODS: We performed secondary analyses of a previously conducted randomized controlled trial (April 2015 to August 2016). Persons with non-insulin-dependent T2D (duration ≤10 years) were randomized to 1-year supervised exercise and individualized dietary counseling (ie, 'U-TURN'), or standard care. The primary HRQoL outcome was change in the 36-item Short Form Health Survey (SF-36) physical component score (PCS) from baseline to 12 months of follow-up, and a key secondary outcome was changes in the SF-36 mental component score (MCS).

RESULTS: We included 98 participants (U-TURN group=64, standard care group=34) with a mean age of 54.6 years (SD 8.9). Between-group analyses at 12-month follow-up showed SF-36 PCS change of 0.8 (95% CI -0.7 to 2.3) in the U-TURN group and deterioration of 2.4 (95% CI -4.6 to -0.1) in the standard care group (difference of 3.2, 95% CI 0.5 to 5.9, p=0.02) while no changes were detected in SF-36 MCS. At 12 months, 19 participants (30%) in the U-TURN group and 6 participants (18%) in the standard care group achieved clinically significant improvement in SF-36 PCS score (adjusted risk ratio 2.6, 95% CI 1.0 to 4.5 corresponding to number needed to treat of 4, 95% CI 1.6 to infinite).

CONCLUSION: In persons with T2D diagnosed for less than 10 years, intensive lifestyle intervention improved the physical component of HRQoL, but not the mental component of HRQoL after 1 year, compared with standard care.

TRIAL REGISTRATION NUMBER: NCT02417012.

Originalsprog Engelsk
Artikelnummer e001840
Tidsskrift BMJ open diabetes research & care
Vol/bind 9
Udgave nummer 1
Sider (fra-til) 1-11
Antal sider 11
ISSN 2052-4897
DOI
Status Udgivet - jan. 2021

Bibliografisk note

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Outcome domains reported by patients, caregivers, healthcare professionals and stakeholders for calcium pyrophosphate deposition (CPPD): A content analysis based on semi-structured qualitative interviews from the OMERACT CPPD working group

Fuller, A., Cai, K., Diaz-Torne, C., Filippou, G., Pascart, T., Hensey, O., Grossberg, D., Christensen, R., Shea, B., Singh, J. A., Tedeschi, S. K., Dalbeth, N. & Abhishek, A., jun. 2021, I: Seminars in Arthritis and Rheumatism. 51, 3, s. 650-654 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Although calcium pyrophosphate deposition (CPPD) disease is common, there are no validated outcome measures for clinical research in this condition. The aim of this study was to generate a list of outcome domains as reported by patients, their caregivers, healthcare professionals (HCPs) and stakeholders to inform the development of an Outcome Measures in Rheumatology (OMERACT) Core Domain Set for CPPD.

METHODS: Patients with CPPD and their caregivers, HCPs and stakeholders took part in semi-structured qualitative interviews to explore potential outcome domains for CPPD clinical research relevant to their lived experience and knowledge of CPPD. Interviews were conducted in six countries across three continents. Data was analysed using manifest content analysis to identify outcome domains, which were tabulated and mapped to the core areas as defined by the OMERACT Filter 2.1.

RESULTS: Thirty-six interviews were conducted in total. Participants comprised of 28 patients (six of which included a caregiver), seven HCPs and one stakeholder. The commonly identified (sub-) domains (d) across the 1) abnormalities/manifestations core area were joint pain (d = 35), joint swelling (d = 27), joint stiffness (d = 25), CPPD flares (d = 25); 2) life-impact core area were overall function (d=35), and specifically the ability to complete daily tasks (d = 25); and 3) societal/resource use core area were use of analgesic medicines (d = 26). Patients more commonly reported joint swelling, stiffness and range of movement, and use of analgesics while HCPs more commonly reported domains relating to presence of CPP crystals, radiologic calcification, joint damage, time to diagnosis and suitability of treatment.

CONCLUSION: Among a number of potential outcome domains identified, articular manifestations, function and analgesic use were most frequently mentioned by participants. These findings will be used to develop an OMERACT Core Domain Set for CPPD.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 3
Sider (fra-til) 650-654
Antal sider 5
ISSN 0049-0172
DOI
Status Udgivet - jun. 2021

Outcome measurement instrument selection for lung physiology in systemic sclerosis associated interstitial lung disease: A systematic review using the OMERACT filter 2.1 process

Roofeh, D., Barratt, S. L., Wells, A. U., Kawano-Dourado, L., Tashkin, D., Strand, V., Seibold, J., Proudman, S., Brown, K. K., Dellaripa, P. F., Doyle, T., Leonard, T., Matteson, E. L., Oddis, C. V., Solomon, J. J., Sparks, J. A., Vassallo, R., Maxwell, L., Beaton, D., Christensen, R., & 2 flereTownsend, W. & Khanna, D., dec. 2021, I: Seminars in Arthritis and Rheumatism. 51, 6, s. 1331-1341 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) is a research organization focused on improving health care outcomes for patients with autoimmune and musculoskeletal diseases. The Connective Tissue Disease-Interstitial Lung Disease (CTD-ILD) Working Group on Lung Physiology is a group within OMERACT charged with identifying outcome measures that should be implemented in studies of patients with CTD-ILD. The OMERACT Filter 2.1 is an evidence-based algorithm used to identify outcome measures that are truthful, feasible, and able to discriminate between groups of interest. Our objective was to summate evidence (published literature, key opinion leader input, patient perspectives) that would influence the CTD-ILD Working Group's vote to accept or reject the use of two measures of lung physiology, the forced vital capacity (FVC) and the diffusion capacity of carbon monoxide (DLco) for use in randomized controlled trials (RTCs) and longitudinal observational studies (LOSs) involving patients with systemic sclerosis associated ILD (SSc-ILD).

METHODS: Patient Research Partners (those afflicted with SSc-ILD) and the CTD-ILD Working Group on Lung Physiology were polled to assess their opinion on the FVC and DLco in terms of feasibility; the CTD-ILD Working Group was also queried on these instruments' face and content validity. We then conducted a systematic literature review to identify articles in the SSc-ILD population that assessed the following measurement properties of FVC and DLco: (1) construct validity, (2) test-retest reliability, (3) longitudinal construct validity, (4) clinical trial discrimination/sensitivity to detect change in clinical trials, and (5) thresholds of meaning. Results were summarized in a Summary of Measurement Properties (SOMP) table for each instrument. OMERACT CTD-ILD Working Group members discussed and voted on the strength of evidence supporting these two instruments and voted to endorse, provisionally endorse, or not endorse either instrument.

RESULTS: Forty Patient Research Partners reported these two measures are feasible (are not an unnecessary burden or represent an infeasible longitudinal assessment of their disease). A majority of the 18 CTD-ILD Working Group members voted that both the FVC and DLco are feasible and have face and content validity. The systematic literature review returned 1,447 non-duplicated articles, of which 177 met eligibility for full text review. Forty-eight studies (13 RCTs, 35 LOSs) were included in the qualitative analysis. The FVC SOMP table revealed high quality, consistent data with evidence of good performance for all five measurement properties, suggesting requisite published evidence to proceed with endorsement. The DLco SOMP table showed a lack of data to support test-retest reliability and inadequate evidence to support clinical trial discrimination. There was unanimous agreement (15 [100%]) among voting CTD-ILD Working Group members to endorse the FVC as an instrument for lung physiology in RCTs and LOSs in SSc-ILD. Based on currently available evidence, DLco did not meet the OMERACT criteria and is not recommended for use in RCTs to represent lung physiology of SSc-ILD. The OMERACT Technical Advisory Group agreed with these decisions.

CONCLUSION: The OMERACT Filter 2.1 was successfully applied to the domain of lung physiology in patients with SSc-ILD. The FVC was endorsed for use in RCTs and LOSs based on the Working Group's vote; DLco was not endorsed.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 51
Udgave nummer 6
Sider (fra-til) 1331-1341
Antal sider 11
ISSN 0049-0172
DOI
Status Udgivet - dec. 2021

Bibliografisk note

Copyright © 2021 Elsevier Inc. All rights reserved.

Outcome measures in rheumatology applied in self-management interventions targeting people with inflammatory arthritis a systematic review of outcome domains and measurement

Hansen, C. W., Esbensen, B. A., Thurah, A. D., Christensen, R. D. K., de Wit, M-C. & Cromhout, P. F., 2021, s. Arthritis Rheumatology 2021; 73 (suppl 9).

Publikation: KonferencebidragKonferenceabstrakt til konferenceForskningpeer review

Outcome reporting in self-management interventions for inflammatory arthritis trials: A systematic review of outcome measures covering self-management domains

Hansen, C., Esbensen, B. A., Christensen, R. D. K., Thurah, AD. & Cromhout, P., 2021, I: Arthritis and Rheumatology. 73, No. S9, s. 1542-5 4 s., 0758.

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

Originalsprog Engelsk
Artikelnummer 0758
Tidsskrift Arthritis and Rheumatology
Vol/bind 73
Udgave nummer No. S9
Sider (fra-til) 1542-5
Antal sider 4
ISSN 2326-5191
Status Udgivet - 2021

Outcomes of acute respiratory distress syndrome in COVID-19 patients compared to the general population: a systematic review and meta-analysis

Dmytriw, A. A., Chibbar, R., Chen, P. P. Y., Traynor, M. D., Kim, D. W., Bruno, F. P., Cheung, C. C., Pareek, A., Chou, A. C. C., Graham, J., Dibas, M., Paranjape, G., Reierson, N. L., Kamrowski, S., Rozowsky, J., Barrett, A., Schmidt, M., Shahani, D., Cowie, K. & Davis, A. R. & 5 flere, Abdelmegeed, M., Touchette, J. C., Kallmes, K. M., Pederson, J. M. & Keesari, P. R., okt. 2021, I: Expert Review of Respiratory Medicine. 15, 10, s. 1347-1354 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Outcomes Reported in Prospective Long-Term Observational Studies and Registries of Patients With Rheumatoid Arthritis Worldwide: An Outcome Measures in Rheumatology Systematic Review

Lopez-Olivo, M. A., Zogala, R. J., des Bordes, J., Zamora, N. V., Christensen, R., Rai, D., Goel, N., Carmona, L., Pratt, G., Strand, V. & Suarez-Almazor, M. E., maj 2021, I: Arthritis Care & Research. 73, 5, s. 649-657 9 s.

Publikation: Bidrag til tidsskriftReviewpeer review

OBJECTIVE: Prospective long-term observational studies (LOS) in rheumatoid arthritis (RA) lack a core set of universally collected outcome measures, particularly patient-centered outcomes, precluding accurate comparisons across studies. Our aim was to identify long-term outcome measures collected and reported in these studies.

METHODS: We conducted a systematic review of registries and LOS of patients with RA, searching in ClinicalTrials.gov, the Agency for Healthcare Research and Quality Registry of Patient Registries, and Google Scholar. The names and acronyms of registries and LOS were further searched in the Medline and Embase databases to retrieve published articles. Two independent reviewers undertook data collection, quality appraisal, and data extraction.

RESULTS: We identified 88 registries/LOS that met our eligibility criteria. These were divided into 2 groups: disease-based (52 [59%]) and therapy-based (36 [41%]). Methodologic and reporting standards varied across the eligible studies. For clinical outcomes, disease activity was recorded in 88 (100%) of all LOS/registries. The most commonly reported measure (86 [98%]) was the composite outcome Disease Activity Score using 28 joints. Of the patient-centered outcomes collected, physical functioning was most frequently reported (75 [85%]) with the Health Assessment Questionnaire (75 [85%]) as the most commonly used instrument within this domain. Other domains of patient-centered outcomes were comparatively infrequently recorded: mental (29 [33%]), social (20 [23%]), and health-related quality of life (37 [42%]).

CONCLUSION: Most registries/LOS collect measures of disease activity and physical function. However, there is substantial heterogeneity in the collection of relevant patient-centered outcomes that measure symptom burden and mental and social ramifications of RA.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
Vol/bind 73
Udgave nummer 5
Sider (fra-til) 649-657
Antal sider 9
ISSN 2151-464X
DOI
Status Udgivet - maj 2021

Parameter Estimation for a Jump Diffusion Model of Type 2 Diabetic Patients in the Presence of Unannounced Meals

Ahdab, M. A., Papez, M., Knudsen, T., Aradottir, T. B., Schmidt, S., Norgaard, K. & Leth, J., 2021, CCTA 2021 - 5th IEEE Conference on Control Technology and Applications. Institute of Electrical and Electronics Engineers Inc., s. 176-183 8 s. (CCTA 2021 - 5th IEEE Conference on Control Technology and Applications).

Publikation: Bidrag til bog/antologi/rapportKonferencebidrag i proceedingsForskningpeer review

Parameter Estimation in Type 2 Diabetes in the Presence of Unannounced Meals and Unmodelled Disturbances

Al Ahdab, M., Glavind Clausen, H., Knudsen, T., Bjork Aradottir, T., Schmidt, S., Norgaard, K. & Leth, J., 2021, 2021 European Control Conference, ECC 2021. Institute of Electrical and Electronics Engineers Inc., s. 1277-1282 6 s. (2021 European Control Conference, ECC 2021).

Publikation: Bidrag til bog/antologi/rapportKonferencebidrag i proceedingsForskningpeer review

Parent-Mediated Interventions for Children and Adolescents With Autism Spectrum Disorders: A Systematic Review and Meta-Analysis

Conrad, C. E., Rimestad, M. L., Rohde, J. F., Petersen, B. H., Korfitsen, C. B., Tarp, S., Cantio, C., Lauritsen, M. B. & Händel, M. N., 12 nov. 2021, I: Frontiers in Psychiatry. 12, s. 773604 773604.

Publikation: Bidrag til tidsskriftReviewpeer review

There has been increasing interest in parent-mediated interventions (PMIs) for children with autism spectrum disorders (ASDs). The objective of this systematic review and meta-analysis was to examine the effect of PMIs compared to no PMI for children with ASD aged 2–17 years. The primary outcome was adaptive functioning rated by a parent or clinician. The secondary outcomes were long-term adaptive functioning rated by the parents, adverse events, core symptoms of ASD, disruptive behavior, parental well-being, quality of life of the child rated by the parents and anxiety. The MEDLINE, PsycInfo, Embase, and CINAHL databases were searched in March 2020. The Cochrane Risk of Bias Tool was used to rate the individual studies, and the certainty in the evidence was evaluated using GRADE. We identified 30 relevant randomized controlled trials (RCTs), including 1,934 participants. A clinically relevant effect of PMIs on parent-rated adaptive functioning was found with a low certainty of evidence [Standard mean difference (SMD): 0.28 (95% CI: −0.01, 0.57)] on Vineland Adaptive Behavior Scales (VABS), whereas no clinically relevant effect was seen for clinician-rated functional level, with a very low certainty of evidence [SMD on Clinical Global Impressions (CGI)-severity scale: SMD −0.45 [95% CI: −0.87, −0.03)]. PMIs may slightly improve clinician-rated autism core symptoms [SMD: −0.35 (95% CI: −0.71, 0.02)]. Additionally, no effect of PMIs on parent-rated core symptoms of ASD, parental well-being or adverse effects was identified, all with a low certainty of evidence. There was a moderate certainty of evidence for a clinically relevant effect on disruptive behavior [SMD: 0.55 (95% Cl: 0.36, 0.74)]. The certainty in the evidence was downgraded due to serious risk of bias, lack of blinding, and serious risk of imprecision due to few participants included in meta-analyses. The present findings suggest that clinicians may consider introducing PMIs to children with ASD, but more high-quality RCTs are needed because the effects are not well-established, and the results are likely to change with future studies. The protocol for the systematic review is registered at the Danish Health Authority website (www.sst.dk).

Originalsprog Engelsk
Artikelnummer 773604
Tidsskrift Frontiers in Psychiatry
Vol/bind 12
Sider (fra-til) 773604
ISSN 1664-0640
DOI
Status Udgivet - 12 nov. 2021

Bibliografisk note

Funding Information:
This research was funded by the Danish Health Authority. The Parker Institute was supported by a core grant by the OAK foundation (OCAY-18-774-OFIL).

Publisher Copyright:
Copyright © 2021 Conrad, Rimestad, Rohde, Petersen, Korfitsen, Tarp, Cantio, Lauritsen and Händel.

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