LetS Get fUnctional! FuNctional Status in pEople With intersTitial Lung Disease
NCT ID: NCT06317831
Last Updated: 2024-04-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
150 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-04-01
Study Completion Date
2028-07-30
Brief Summary
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This study aims to i) To characterize the functional status and explore the determinants of functional status decline of people with IlD ii)To determine the measurement properties of functional status instruments in people with Interstitial lung diseases (ILD) iii) To identify the impact of ILD and the participants' perspectives on functional status through interviews iv) Explore the progression of functional status progression in people with ILD and v) Develop a multidimensional index, incorporating functional status parameters, to predict mortality in people with ILD.
Patients with ILD will be recruited via the pulmonology services at hospitals, namely from Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV) and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up spirometric measurements and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.
The assessments will be conducted at 6 time points: baseline and 1 week after for instrument validation, followed by assessments every 6 months for 2 years.
It is expected that: i) Functional status limitations can be comprehensively identified and measured in individuals with ILD. ii) Some measures are valid and reliable indicators of functional status in individuals with ILD. iii) Different profiles of functional status progression will be identified in individuals with ILD, including stable, slow, and fast decline. iv) A multidimensional index incorporating functional status will improve the accuracy of predicting mortality and outperform the predictive ability of the current GAP Index.
Patients with ILD will be recruited via the pulmonology services at hospitals, namely from Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV) and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up spirometric measurements and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.
The assessments will be conducted at 6 time points: baseline and 1 week after for instrument validation, followed by assessments every 6 months for 2 years.
It is expected that: i) Functional status limitations can be comprehensively identified and measured in individuals with ILD. ii) Some measures are valid and reliable indicators of functional status in individuals with ILD. iii) Different profiles of functional status progression will be identified in individuals with ILD, including stable, slow, and fast decline. iv) A multidimensional index incorporating functional status will improve the accuracy of predicting mortality and outperform the predictive ability of the current GAP Index.
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Detailed Description
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Functional status is a fundamental, patient-centred and multidimensional outcome for individuals with interstitial lung disease (ILD). Functional status decline is the most frequent impact reported in this population. It is often associated with an increased dependency on others, loss of productivity and premature death. It is also an important predictor of exacerbations, hospitalisations, readmissions, and mortality. Functional status decline is so overwhelming for individuals and society, that it has been recently recognised as an international top priority for patient-centred research in ILD. Yet, little is known how functional status is impaired and progresses in ILD, limiting the help health professionals are able to provide to optimise care.
ILD are a highly disabling group of chronic respiratory diseases characterised by widespread inflammation and scarring (fibrosis) of the lung. In people with ILD, the destruction of the pulmonary capillary bed and vasoconstriction, results in impaired gas exchange and circulatory limitation, which can lead to reduced exercise capacity. Exercise capacity may be further limited due to peripheral muscle dysfunction caused by physical deconditioning and drug-induced myopathy from ILD treatment with corticosteroids. Taken together these factors contribute to the high symptom burden experienced. This population, therefore, presents pulmonary (e.g., dyspnoea, cough) and extra-pulmonary (e.g., decreased exercise tolerance, skeletal muscle dysfunction, fatigue) traits and experience a downward spiral of debilitating symptoms and functional status decline.
Functional status is defined as the ability to perform normal daily activities required to meet basic needs, fulfil usual roles, and maintain health and well-being. It includes functional capacity, i.e., an individual's maximum capacity to perform daily life activities in a standardized environment; and functional performance, i.e., activities people actually do during the course of their daily life. Adequate assessment of functional status must, therefore, include measures of functional capacity and performance, to identify the presence or absence of decline and inform on preventive and/or rehabilitative strategies. Studies focussing on the comprehensive assessment of functional status in people with ILD using reliable and validated instruments are, however, lacking.
Therefore, the primary aim of SUNSET study is to characterize the functional status and explore the determinants of functional status decline of people with ILD.
Secondary aims are to: i) To determine the measurement properties of functional status instruments in people with ILD ii) To identify the impact of ILD and the participants' perspectives on functional status through interviews iii) Explore the progression of functional status progression in people with ILD and iv) Develop a multidimensional index, incorporating functional status parameters, to predict mortality in people with ILD.
According to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline, a minimum sample size of 100 will be required for task 1.
For task 2, number of participants needed for interviews will be determined by data saturation.
For task 3, a sample size estimation was performed in GPower to detect a small effect size (eta\^2=0.02), with 80% power, 5% significance level and moderate correlation among repeated measures (r=0.5) in a repeated measures analysis of variance. The minimum sample size estimation was 81 participants Considering a dropout rate of 50%, we will aim to recruit 122 participants.
This study is a multicentric observational longitudinal research project comprising four tasks. It involves collaboration between institutions, namely the University of Aveiro, along with three healthcare facilities: Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV), and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Task 1 aims to validate the measures of functional status. For this, two assessment moments will be performed. The first assessment will be conducted at baseline and will be in line with the routine appointment. The second assessment will be conducted 7 days after baseline. Task 2 will use the information collected in Task 1 and conduct semi-structured individual interviews to characterize the functional status from the perspective of people with ILD. Task 3 will then conduct an observational longitudinal study using the most valid and reliable measures of functional status identified in task 1 and mortality rates will be explored during task 3. For this, patients will be contacted to participate in four timepoints of assessment (at 6, 12, 18, and 24 months) which will be in line with the routine appointment. Table 1 details the measurements performed in each timepoint. If an outcome measure is found to not be valid and reliable during task 1, that outcome measure will not be collected in task 3 nor replaced by another outcome measure. In Task 4, the data collected in Task 3 will be used to develop a multidimensional index incorporating functional status parameters to predict mortality in people with ILD. The study assessments will take approximately 90 minutes and will take place at Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV), and Centro Hospitalar de Entre o Douro e Vouga (CHEDV).
Patients with ILD will be recruited via the pulmonology services at hospitals. Pulmonologists will explain the study briefly and inform the researchers about interested participants. The researchers will provide further information about the study, clarify any doubts and collect the informed consent. Participants will be eligible if they are: i) ≥18 years, ii) diagnosed with any type of ILD, iii) fluent in Portuguese and iv) able to provide informed consent. Participants will be excluded if they have: i) other respiratory diseases ii) a history of acute cardiac/respiratory condition in the previous month; iii) present signs of cognitive impairment; iv) significant cardiovascular, neurological and/or musculoskeletal disease that may limit their participation; v) current neoplasia, vi) other autoimmune diseases (aside from ILD). Once task 1 is finished, included participants will be contacted again to verify if they still match the inclusion/exclusion criteria and are still willing to participate in task 3.
Baseline data will be collected: Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up lung function and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.
Data analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) software, incorporating both descriptive and inferential statistics. To examine changes in outcome measures, data from baseline and subsequent assessments will be compared. Additionally, the interviews will be transcribed and analysed using thematic analysis.
ILD are a highly disabling group of chronic respiratory diseases characterised by widespread inflammation and scarring (fibrosis) of the lung. In people with ILD, the destruction of the pulmonary capillary bed and vasoconstriction, results in impaired gas exchange and circulatory limitation, which can lead to reduced exercise capacity. Exercise capacity may be further limited due to peripheral muscle dysfunction caused by physical deconditioning and drug-induced myopathy from ILD treatment with corticosteroids. Taken together these factors contribute to the high symptom burden experienced. This population, therefore, presents pulmonary (e.g., dyspnoea, cough) and extra-pulmonary (e.g., decreased exercise tolerance, skeletal muscle dysfunction, fatigue) traits and experience a downward spiral of debilitating symptoms and functional status decline.
Functional status is defined as the ability to perform normal daily activities required to meet basic needs, fulfil usual roles, and maintain health and well-being. It includes functional capacity, i.e., an individual's maximum capacity to perform daily life activities in a standardized environment; and functional performance, i.e., activities people actually do during the course of their daily life. Adequate assessment of functional status must, therefore, include measures of functional capacity and performance, to identify the presence or absence of decline and inform on preventive and/or rehabilitative strategies. Studies focussing on the comprehensive assessment of functional status in people with ILD using reliable and validated instruments are, however, lacking.
Therefore, the primary aim of SUNSET study is to characterize the functional status and explore the determinants of functional status decline of people with ILD.
Secondary aims are to: i) To determine the measurement properties of functional status instruments in people with ILD ii) To identify the impact of ILD and the participants' perspectives on functional status through interviews iii) Explore the progression of functional status progression in people with ILD and iv) Develop a multidimensional index, incorporating functional status parameters, to predict mortality in people with ILD.
According to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline, a minimum sample size of 100 will be required for task 1.
For task 2, number of participants needed for interviews will be determined by data saturation.
For task 3, a sample size estimation was performed in GPower to detect a small effect size (eta\^2=0.02), with 80% power, 5% significance level and moderate correlation among repeated measures (r=0.5) in a repeated measures analysis of variance. The minimum sample size estimation was 81 participants Considering a dropout rate of 50%, we will aim to recruit 122 participants.
This study is a multicentric observational longitudinal research project comprising four tasks. It involves collaboration between institutions, namely the University of Aveiro, along with three healthcare facilities: Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV), and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Task 1 aims to validate the measures of functional status. For this, two assessment moments will be performed. The first assessment will be conducted at baseline and will be in line with the routine appointment. The second assessment will be conducted 7 days after baseline. Task 2 will use the information collected in Task 1 and conduct semi-structured individual interviews to characterize the functional status from the perspective of people with ILD. Task 3 will then conduct an observational longitudinal study using the most valid and reliable measures of functional status identified in task 1 and mortality rates will be explored during task 3. For this, patients will be contacted to participate in four timepoints of assessment (at 6, 12, 18, and 24 months) which will be in line with the routine appointment. Table 1 details the measurements performed in each timepoint. If an outcome measure is found to not be valid and reliable during task 1, that outcome measure will not be collected in task 3 nor replaced by another outcome measure. In Task 4, the data collected in Task 3 will be used to develop a multidimensional index incorporating functional status parameters to predict mortality in people with ILD. The study assessments will take approximately 90 minutes and will take place at Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV), and Centro Hospitalar de Entre o Douro e Vouga (CHEDV).
Patients with ILD will be recruited via the pulmonology services at hospitals. Pulmonologists will explain the study briefly and inform the researchers about interested participants. The researchers will provide further information about the study, clarify any doubts and collect the informed consent. Participants will be eligible if they are: i) ≥18 years, ii) diagnosed with any type of ILD, iii) fluent in Portuguese and iv) able to provide informed consent. Participants will be excluded if they have: i) other respiratory diseases ii) a history of acute cardiac/respiratory condition in the previous month; iii) present signs of cognitive impairment; iv) significant cardiovascular, neurological and/or musculoskeletal disease that may limit their participation; v) current neoplasia, vi) other autoimmune diseases (aside from ILD). Once task 1 is finished, included participants will be contacted again to verify if they still match the inclusion/exclusion criteria and are still willing to participate in task 3.
Baseline data will be collected: Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up lung function and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.
Data analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) software, incorporating both descriptive and inferential statistics. To examine changes in outcome measures, data from baseline and subsequent assessments will be compared. Additionally, the interviews will be transcribed and analysed using thematic analysis.
Conditions
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Interstitial Lung Diseases
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ≥18 years
* Diagnosed with any type of ILD
* Fluent in Portuguese
* Able to provide informed consent.
* Diagnosed with any type of ILD
* Fluent in Portuguese
* Able to provide informed consent.
Exclusion Criteria
* Other respiratory diseases
* A history of acute cardiac/respiratory condition in the previous month
* Present signs of cognitive impairment
* Significant cardiovascular, neurological and/or musculoskeletal disease that may limit their participation
* Current neoplasia
* Other autoimmune diseases (aside from ID).
* A history of acute cardiac/respiratory condition in the previous month
* Present signs of cognitive impairment
* Significant cardiovascular, neurological and/or musculoskeletal disease that may limit their participation
* Current neoplasia
* Other autoimmune diseases (aside from ID).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fundação para a Ciência e a Tecnologia
OTHER
Sponsor Role
collaborator
Aveiro University
OTHER
Sponsor Role
lead
Responsible Party
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Alda Sofia Pires de Dias Marques
Senior Lecturer
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Alda S. Marques, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Health Sciences of the University of Aveiro (ESSUA)
Locations
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University of Aveiro
Aveiro, , Portugal
Site Status
RECRUITING
Countries
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Portugal
Central Contacts
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Facility Contacts
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References
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Aronson KI, Danoff SK, Russell AM, Ryerson CJ, Suzuki A, Wijsenbeek MS, Bajwah S, Bianchi P, Corte TJ, Lee JS, Lindell KO, Maher TM, Martinez FJ, Meek PM, Raghu G, Rouland G, Rudell R, Safford MM, Sheth JS, Swigris JJ. Patient-centered Outcomes Research in Interstitial Lung Disease: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2021 Jul 15;204(2):e3-e23. doi: 10.1164/rccm.202105-1193ST.
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Dowman L, Hill CJ, May A, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2021 Feb 1;2(2):CD006322. doi: 10.1002/14651858.CD006322.pub4.
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BACKGROUND
Tonelli R, Cocconcelli E, Lanini B, Romagnoli I, Florini F, Castaniere I, Andrisani D, Cerri S, Luppi F, Fantini R, Marchioni A, Beghe B, Gigliotti F, Clini EM. Effectiveness of pulmonary rehabilitation in patients with interstitial lung disease of different etiology: a multicenter prospective study. BMC Pulm Med. 2017 Oct 10;17(1):130. doi: 10.1186/s12890-017-0476-5.
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BACKGROUND
Leidy NK. Functional status and the forward progress of merry-go-rounds: toward a coherent analytical framework. Nurs Res. 1994 Jul-Aug;43(4):196-202.
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Kocks JW, Asijee GM, Tsiligianni IG, Kerstjens HA, van der Molen T. Functional status measurement in COPD: a review of available methods and their feasibility in primary care. Prim Care Respir J. 2011 Sep;20(3):269-75. doi: 10.4104/pcrj.2011.00031.
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BACKGROUND
Dedding C, Cardol M, Eyssen IC, Dekker J, Beelen A. Validity of the Canadian Occupational Performance Measure: a client-centred outcome measurement. Clin Rehabil. 2004 Sep;18(6):660-7. doi: 10.1191/0269215504cr746oa.
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BACKGROUND
Medina-Mirapeix F, Bernabeu-Mora R, Llamazares-Herran E, Sanchez-Martinez MP, Garcia-Vidal JA, Escolar-Reina P. Interobserver Reliability of Peripheral Muscle Strength Tests and Short Physical Performance Battery in Patients With Chronic Obstructive Pulmonary Disease: A Prospective Observational Study. Arch Phys Med Rehabil. 2016 Nov;97(11):2002-2005. doi: 10.1016/j.apmr.2016.05.004. Epub 2016 May 30.
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BACKGROUND
Reuben DB, Siu AL. An objective measure of physical function of elderly outpatients. The Physical Performance Test. J Am Geriatr Soc. 1990 Oct;38(10):1105-12. doi: 10.1111/j.1532-5415.1990.tb01373.x.
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BACKGROUND
Hill CJ, Denehy L, Holland AE, McDonald CF. Measurement of functional activity in chronic obstructive pulmonary disease: the grocery shelving task. J Cardiopulm Rehabil Prev. 2008 Nov-Dec;28(6):402-9. doi: 10.1097/HCR.0b013e31818c3c65.
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BACKGROUND
Briand J, Behal H, Chenivesse C, Wemeau-Stervinou L, Wallaert B. The 1-minute sit-to-stand test to detect exercise-induced oxygen desaturation in patients with interstitial lung disease. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753466618793028. doi: 10.1177/1753466618793028.
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BACKGROUND
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
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Dowman L, McDonald CF, Hill CJ, Lee A, Barker K, Boote C, Glaspole I, Goh N, Southcott A, Burge A, Ndongo R, Martin A, Holland AE. Reliability of the hand held dynamometer in measuring muscle strength in people with interstitial lung disease. Physiotherapy. 2016 Sep;102(3):249-55. doi: 10.1016/j.physio.2015.10.002. Epub 2015 Oct 22.
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Karagiannis C, Savva C, Korakakis V, Matheou I, Adamide T, Georgiou A, Xanthos T. Test-Retest Reliability of Handgrip Strength in Patients with Chronic Obstructive Pulmonary Disease. COPD. 2020 Oct;17(5):568-574. doi: 10.1080/15412555.2020.1808604. Epub 2020 Aug 19.
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Reilly CC, Bausewein C, Garrod R, Jolley CJ, Moxham J, Higginson IJ. Breathlessness during daily activity: The psychometric properties of the London Chest Activity of Daily Living Scale in patients with advanced disease and refractory breathlessness. Palliat Med. 2017 Oct;31(9):868-875. doi: 10.1177/0269216316680314. Epub 2016 Dec 15.
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Zhang X, Tan SS, Bilajac L, Alhambra-Borras T, Garces-Ferrer J, Verma A, Koppelaar E, Markaki A, Mattace-Raso F, Franse CB, Raat H. Reliability and Validity of the Tilburg Frailty Indicator in 5 European Countries. J Am Med Dir Assoc. 2020 Jun;21(6):772-779.e6. doi: 10.1016/j.jamda.2020.03.019. Epub 2020 May 6.
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Patel AS, Siegert RJ, Brignall K, Gordon P, Steer S, Desai SR, Maher TM, Renzoni EA, Wells AU, Higginson IJ, Birring SS. The development and validation of the King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire. Thorax. 2012 Sep;67(9):804-10. doi: 10.1136/thoraxjnl-2012-201581. Epub 2012 May 3.
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Van Remoortel H, Raste Y, Louvaris Z, Giavedoni S, Burtin C, Langer D, Wilson F, Rabinovich R, Vogiatzis I, Hopkinson NS, Troosters T; PROactive consortium. Validity of six activity monitors in chronic obstructive pulmonary disease: a comparison with indirect calorimetry. PLoS One. 2012;7(6):e39198. doi: 10.1371/journal.pone.0039198. Epub 2012 Jun 20.
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Other Identifiers
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2023.03936.BDANA
Identifier Type: -
Identifier Source: org_study_id
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