Cited by 588Reliability and Agreement in MeasurementDelphi Technique in ResearchMeta-analysis and systematic reviews

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COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study

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Mokkink, L. B., Boers, M., van der Vleuten, C. P. M., Bouter, L. M., Alonso, J., Patrick, D. L., de Vet, H. C. W., Terwee, C. B.·2020·BMC Medical Research Methodology

DOI 10.1186/s12874-020-01179-5PMC PMC7712525

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Abstract

Background: Scores on an outcome measurement instrument depend on the type and settings of the instrument used, how instructions are given to patients, how professionals administer and score the instrument, etc. The impact of all these sources of variation on scores can be assessed in studies on reliability and measurement error, if properly designed and analyzed. The aim of this study was to develop standards to assess the quality of studies on reliability and measurement error of clinician-reported outcome measurement instruments, performance-based outcome measurement instrument, and laboratory values. Methods: We conducted a 3-round Delphi study involving 52 panelists. Results: Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how the results of a study inform us about the quality of the outcome measurement instrument at issue. Consensus was reached on components of outcome measurement instruments, i.e. the potential sources of variation. Next, we reached consensus on standards on design requirements ( n = 5), standards on preferred statistical methods for reliability ( n = 3) and measurement error ( n = 2), and their ratings on a four-point scale. There was one term for a component and one rating of one standard on which no consensus was reached, and therefore required a decision by the steering committee. Conclusion: We developed a tool that enables researchers with and without thorough knowledge on measurement properties to assess the quality of a study on reliability and measurement error of outcome measurement instruments.

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Method
Measurement proprieties of the CROM instrument for assessing head posture, neck retraction and protraction
Elizagaray-García, I., Obispo-Villamayor, Á., Prats-Martínez, C., Prieto-Hernández, G., & Carvalho, G. F. (2024) · Musculoskeletal Science and Practice · doi:10.1016/j.msksp.2024.102950 · Cited by 4
Performance Quality Assessment in Ballet, Modern and Contemporary Dance: A Two-Step Systematic Review
Wirdnam, M., Bonello, C., Mayes, S., Cook, J. L., & Ferrar, K. (2024) · Journal of Dance Medicine & Science · doi:10.1177/1089313x241272139 · Cited by 3
“17,18 Reflecting the 2-fold aim of the study, a 2-step systematic review with two separate literature searches was conducted.”
Influential
Measurement properties of the 5-repetition sit-to-stand test in patients with lumbar degenerative disorders: COSMIN systematic review
Klukowska, A. M., Ciobanu-Caraus, O., Germans, M. R., Vandertop, W. P., Schröder, M. L., & Staartjes, V. E. (2024) · The Spine Journal · doi:10.1016/j.spinee.2024.10.027 · Cited by 3
Procurement performance improvement through adoption of e-procurement: a study of small and medium enterprises
Ntshingila, M. L. (2025) · EUREKA Social and Humanities · doi:10.21303/2504-5571.2025.003703 · Cited by 5
How do we measure dysarthria after stroke? A systematic review to guide the core outcome set for dysarthria
Mitchell, C., Kouaissi, S. E., Duncan-Zaleski, M., Bowen, A., Conroy, P., Whelan, B., Wallace, S. J., Cheyne, J. D., & Kirkham, J. J. (2025) · BMJ Open · doi:10.1136/bmjopen-2025-099662 · Cited by 3
“…following: type of measurement tool and construct measured, number and aetiology of participants on whom it was tested, test procedure and analysis method used, psychometric properties tested and the results of their analysis, clinical utility and quality assessment (COSMIN risk of bias tool 19 ).”
Validation of the Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) in Brazilian SLE patients
Machado, C. M. M., Lanna, C. C. D., Garrido, J. C., Monticielo, O. A., Klumb, E. M., Tres, G. L., Moura, F. D. M., & Telles, R. W. (2025) · Rheumatology · doi:10.1093/rheumatology/keaf366 · Cited by 3
How many strides are needed for reliable markerless gait analysis?
Carvalho, A., Vanrenterghem, J., Pataky, T. C., Robinson, M. A., Veloso, A., & Moniz-Pereira, V. (2025) · Gait & Posture · doi:10.1016/j.gaitpost.2025.110020 · Cited by 3
Single joint posterior chain isometric testing using force plates: A systematic review of the methodologies and reliability of testing methods
Fahey, J. T., Bramah, C., Barber, R., Williams, J. R., McMahon, J. J., Comfort, P., & Ripley, N. J. (2025) · Journal of Sports Sciences · doi:10.1080/02640414.2025.2606621 · Cited by 3
“Studies which included relative reliability (intraclass correlation coefficients [ICC]) were assessed for risk of bias using the COSMIN tool (Mokkink et al., 2020).”
Developing an appropriate depression and anxiety screening tool for use with Australian First Nations peoples living in the Torres Strait and Northern Peninsula Area of Australia: Protocol for a Delphi study
Meldrum, K., Wallace, V., Webb, T., Ridgway, L., Quigley, R., Strivens, E., & Russell, S. (2023) · PLoS ONE · doi:10.1371/journal.pone.0292162 · Cited by 3
“Secondly, panellist drop-out from round-to-round is a potential limitation, especially when the rounds are conducted over a long period of time and are expecting a large time commitment [31].”
Influential
School Participation Questionnaire (SPQ): Italian Translation, Cultural Adaptation, and Pilot Testing in Children with Neurodevelopmental Disorders
Pietragalla, G., Galeoto, G., Moresi, M., Ruffini, M., Simeon, R., Panuccio, F., Valente, D., & Berardi, A. (2024) · Brain Sciences · doi:10.3390/brainsci14070644 · Cited by 3
“The translation and cultural adaptation were conducted by applying international guidelines [21–23, For construct validity analysis, a comparison was carried out with the SPM scale, as the it investigates the child’s sensory processing, practices, and social participation, focusing not only on the…”
Method
KOJI AWARENESS, a self-rating whole-body movement assessment system, has intersession reliability and comparability to external examiner rating
Takasaki, H., & Kanayasu, S. (2024) · PLoS ONE · doi:10.1371/journal.pone.0308973 · Cited by 3
“For absolute reliability, minimum detectable changes (MDCs) were calculated using the standard deviations of the values and the ICC values on the basis of the following formulas: Interpretations of the ICC and kappa values were as follows: insufficient, < .7; sufficient, � .7 [15].”
Method
Validation of the Hungarian version of the General Oral Health Assessment Index (GOHAI) in clinical and general populations
Oszlánszky, J., Mensch, K., Hermann, P., & Zrubka, Z. (2024) · BMC Oral Health · doi:10.1186/s12903-024-05198-2 · Cited by 3
Tele-patient-reported outcome measures (telePROM) in follow-up of endometriosis: a validity and test-retest reliability study of an endometriosis-specific questionnaire (EQ)
Feenstra, M. M., Sidenius, A., Nielsen, C., Kristensen, S. B., & Rudnicki, M. (2025) · Current Medical Research and Opinion · doi:10.1080/03007995.2025.2470749 · Cited by 3
“Validity and reliability constitute crucial psychometric attributes of an instrument to ensure measurements are accurate and dependable 22,23 .”
Digital hand‐held arthrometry is a reliable and accurate adjunct for diagnosing acute anterior cruciate ligament tears
Norris, R. N., Price, A., Maddox, T. W., Boswell, W., Kerin, C., & Oldershaw, R. A. (2025) · Journal of Experimental Orthopaedics · doi:10.1002/jeo2.70251 · Cited by 2
“…mitigate bias related to the study design, signalling questions from the Consensus ‐ based Standards for the selection of health Measurement Instruments (COSMIN) [23] and Quality Assessment of Diagnostic Accuracy Studies (QUADAS ‐ 2) [37] risk of bias tools were considered during the design phase.”
Evaluation of the Psychometric Properties of the Health Assessment Questionnaire (HAQ) in a Population of Individuals With Multiple Sclerosis
Berardi, A., Conte, A., Cimmino, L., Cimmino, C., Baione, V., Crisafulli, S. G., Tofani, M., Tartaglia, M., Fabbrini, G., & Galeoto, G. (2022) · Frontiers in Neurology · doi:10.3389/fneur.2022.847786 · Cited by 3
Evaluation of the psychometric properties of patient-reported and clinician-reported outcome measures of chemotherapy-induced peripheral neuropathy: a COSMIN systematic review protocol
Bérubé-Mercier, P., Tapp, D., Cimon, M.-È., Li, T., Park, S. B., Bouhêlier, É., McGarragle, K., Robichaud, L.-A., Gewandter, J. S., Bouchard, M., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-057950 · Cited by 3
Measurement Properties of the Mayo-Portland Adaptability Inventory (MPAI-4) and Related Measures: A Systematic Review
Ataman, R., Thomas, A., Roberge‐Dao, J., McKerral, M., Auger, C., Wittich, W., Talla, P. K., Boychuck, Z., & Ahmed, S. (2022) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2022.08.051 · Cited by 3
Psychometric properties of the Chinese version of the Cognitive Reserve Assessment Scale in Health in patients with cancer
Liu, H., Li, Y., Li, Y., Wang, J., Su, N., Cui, N., Xu, K., Sun, Y., & Cao, F. (2023) · BMC Psychiatry · doi:10.1186/s12888-022-04506-w · Cited by 3
Validity and reliability of the single camera marker less motion capture system using RGB-D sensor to measure shoulder range-of-motion: A protocol for systematic review and meta-analysis
Lee, U., Lee, S., Kim, S.-A., Lee, J.-D., & Lee, S. (2023) · Medicine · doi:10.1097/md.0000000000033893 · Cited by 3
Psychometric properties of portable devices used in kinematic gait assessment after stroke: a systematic review protocol
da Silva, R. S., Silva, S., Santos, V., Fernandes, J. G., Oliveira, R., Ribeiro, K. M. O. B. D. F., Fernandes, A. B. G. S., & Ribeiro, T. S. (2023) · F1000Research · doi:10.12688/f1000research.134161.1 · Cited by 1
“of studies that perform this analysis using the “COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments”.(18)”
Method
Translation, reliability, and validity of the Brazilian-Portuguese version of the Brachial Plexus Outcome Measure scale (BPOM-Br)
Grechi, G., Figueiredo, R. D. M., Nakamoto, L., Queiroz, I. P., da Rocha, M. P. P., de Sousa, R. R., & Leite, H. R. (2023) · Disability and Rehabilitation · doi:10.1080/09638288.2023.2251877 · Cited by 3
“The sample size followed the recommendations of the COSMIN standards, which recommend a minimum sample size of 50 subjects for reliability studies [18].”
Reliability of inter-recti distance measurement on ultrasound images captured by novice examiners
Chmielewska, D. D., Cebula, M., Gnat, R., Rudek-Zeprzałka, M., Gruszczyńska, K., Baron, J., & Opala-Berdzik, A. (2023) · Physiotherapy Theory and Practice · doi:10.1080/09593985.2023.2255897 · Cited by 3
“The study design regarding the intra and inter-examiner reliability was based on the COSMIN checklist (Mokkink et al., 2020).”
Cross-Cultural Adaptation and Measurement Properties Analysis of the Brazilian Portuguese Version of the ICIQ-VS
Fabricio, A. M. F., Moreira, R. D. F. C., Poli, G. G., Venancio, M. G., Silva, C. M. D. A., Ferreira, C. H. J., Driusso, P., & Beleza, A. C. S. (2024) · International Urogynecology Journal · doi:10.1007/s00192-024-05747-x · Cited by 3
Translation, contextual adaptation, and reliability of the Danish Concept of Pain Inventory (COPI-Adult (DK)) – A self-reported outcome measure
Eiger, B., Straszek, C. L., Pate, J. W., & Rathleff, M. S. (2024) · Scandinavian Journal of Pain · doi:10.1515/sjpain-2023-0092 · Cited by 3
Instruments for Assessing Family Functioning in Adults Patients with Cancer: A Systematic Review of Measurement Properties
Alfaro‐Díaz, C., Esandi, N., Clausen, A. M., Canga‐Armayor, N., Pueyo‐Garrigues, M., & Dieperink, K. B. (2024) · Seminars in Oncology Nursing · doi:10.1016/j.soncn.2024.151729 · Cited by 3
European Portuguese version of the Mini-BESTest: a cross-cultural adaptation and psychometric measurements in individuals with sensorimotor impairments
Freitas, M., Pinho, F., Martins, N. A., Pinho, L., Silva, S., Figueira, V., Vilas‐Boas, J. P., & Silva, A. (2024) · Disability and Rehabilitation · doi:10.1080/09638288.2024.2402085 · Cited by 3
“The Mini-BESTest_EP demonstrated excellent internal consistency with a Cronbach’s alpha of 0.89, indicating that the measured variables consistently reflect the same construct [59].”
Influential
Translation and validation of Malay version of NIOSH worker well-being questionnaire (WellBQ)
Sampil, N. S., Daud, A., & Hairon, S. M. (2025) · PLoS ONE · doi:10.1371/journal.pone.0322451 · Cited by 3
Psychometric properties of outcome measures for lower-limb absence: A protocol for a systematic review
Tan, J. M., Halford, G. R. J., McBain, B., Lukin, M., & Köhler, F. (2023) · Prosthetics and Orthotics International · doi:10.1097/pxr.0000000000000220 · Cited by 3
“Where applicable, the COSMIN 2020 update for PerfOMs will also be used.(7) In accordance with the COSMIN”
Method
Assessing Anaerobic Speed Reserve: A Systematic Review on the Validity and Reliability of Methods to Determine Maximal Aerobic Speed and Maximal Sprinting Speed in Running-based SportsPreprint
Thron, M., Düking, P., Ruf, L., Härtel, S., Wöll, A., & Altmann, S. (2023) · Research Square · doi:10.21203/rs.3.rs-2686847/v1 · Cited by 3
COSMIN: Consensus-Based Standards for the Selection of Health Status Measurement Instruments
Mokkink, L. B., Terwee, C. B., & de Vet, H. C. W. (2023) · Springer eBooks · doi:10.1007/978-3-031-17299-1_595 · Cited by 3
Self-citation
Measurement properties of physical activity in adults with bronchiectasis: A systematic review protocol
Bhat, A., Lee, A. L., Maiya, A. G., & Vaishali, K. (2023) · F1000Research · doi:10.12688/f1000research.138593.1 · Cited by 2
“For these reasons, an adapted COSMIN Risk of Bias checklist on reliability and measurement error will be used for performance-based outcome measures.(31) Any discrepancies will be discussed with AL.”
Method
Occupational Therapy Assessments of Cortical or Cerebral Visual Impairment: A Systematic Review
Weisser-Pike, O., Mitchell, A. W., & Cordova, L. (2023) · American Journal of Occupational Therapy · doi:10.5014/ajot.2023.050313 · Cited by 2
“We independently used the COnsensus-based Standards for the selection of health Measurement INstru-ments (COSMIN) Risk of Bias checklist (Mokkink et al., 2020, 2021; Mokkink, de Vet, et al., 2018; Mokkink, Prinsen, et al., 2018; Terwee et al., 2018) to assess the methodological quality of the…”
COSMIN Yanlılık Riski Kontrol Listesi’nin Türkçe’ye Uyarlanması
Uğur, H. G., Bektaş, M., Hendekçi, A., YAVUZ, A. Y., & ÇİÇEK, E. (2024) · Ordu Üniversitesi Hemşirelik Çalışmaları Dergisi · doi:10.38108/ouhcd.1359302 · Cited by 2
Development of a Vaccine Advocacy Scale for Childhood Vaccines and Psychometric Evaluation: A Methodological Study
YORULMAZ, D. S. (2025) · Journal of Evaluation in Clinical Practice · doi:10.1111/jep.70056 · Cited by 3
“Numerous methods, including Cronbach's alpha coefficient, two ‐ half test consistency, item ‐ total score correlation, and test ‐ retest reliability, are used to assess the reliability of measurement tools [39].”
Measuring health-related quality of life in patients with peripheral vascular malformations with PROMIS® computerized adaptive tests
Marreiros, D. J. D. O., Lokhorst, M. M., Young‐Afat, D. A., Stor, M. L. E., Horbach, S. E. R., Roorda, L. D., Luijten, M. A. J., Haverman, L., van der Horst, C. M. A. M., & Spuls, P. I. (2025) · Journal of Plastic Reconstructive & Aesthetic Surgery · doi:10.1016/j.bjps.2025.05.036 · Cited by 2
Diagnostic reliability of the FinSpine nationwide spine surgery registry: Comparison between clinical registry diagnoses and blinded imaging assessments
Repo, J. P., Pernaa, K. I., Pekkanen, L. T., Hatakka, J., Mäntymäki, H., Malmivaara, A. V., Salo, H., Suominen, E. N., Kankare, J., & Huttunen, J. (2025) · Brain and Spine · doi:10.1016/j.bas.2025.104325 · Cited by 2
“The FinSpine research steering group developed the study methodology, following the Consensus-based standards for the selection of health measurement instruments Risk of Bias tool (Mokkink et al., 2020) guidelines.”
Validity and reliability of modified box and block test and targeted box and block test in patients with stroke
Akkurt, L., Aksoy, C. C., & Yaman, F. (2025) · Applied Neuropsychology Adult · doi:10.1080/23279095.2025.2545543 · Cited by 2
Peak VO2 and heart rate depend on running slope: a systematic review and meta-analysis
de Lucas, R. D., Lanzarini, L. D. V., Lana, I. D., Turnes, T., Ventura, T. P., Denadai, B. S., & Borszcz, F. K. (2025) · Sport Sciences for Health · doi:10.1007/s11332-025-01543-2 · Cited by 3
“I) sample size; II) reporting of participants’ details; III) reporting of participants’ inclusion/exclusion criteria; and IV) reporting of stability of participants and test conditions) adapted from the COSMIN tool [26] (Supplementary Material, Table S3).”
New clinical measures of hand and wrist proprioception: a pilot study for evaluating discriminative validity and test-retest reliability in individuals with wrist disability
Sontag, M., Röijezon, U., Brogårdh, C. B., & Ekstrand, E. (2025) · Journal of Rehabilitation Medicine – Clinical Communications · doi:10.2340/jrm-cc.v8.43929 · Cited by 2
Applying the principles of risk management in male professional football: a feasibility study, introducing the Aspetar sports injury and illness risk management tool
Hassanmirzaei, B., Tabben, M., Schumacher, Y. O., Mammeri, H., Chaabane, M., Rekik, R., Drumond, R., Chebbi, S., & Bahr, R. (2025) · British Journal of Sports Medicine · doi:10.1136/bjsports-2025-110063 · Cited by 2
Reliability, Standard Error of Measurement, and Smallest Detectable Change of the Recommended Tests by the Osteoarthritis Research Society International in People With Knee Osteoarthritis
Ramalho, R. B., Montilha, V. B. V., Casonato, N. A., Mattiello, S. M., & Selistre, L. F. A. (2025) · Journal of Manipulative and Physiological Therapeutics · doi:10.1016/j.jmpt.2025.10.024 · Cited by 2
The Evaluation Measure for BRACe Experience (EMBRACE): developing a patient-reported outcome measure for infants with hip dysplasia
Craven, J., Theunissen, W. W. E. S., Lane, O., Beattie, S., Griffin, X. L., & Perry, D. C. (2025) · Bone & Joint Open · doi:10.1302/2633-1462.611.bjo-2025-0117.r1 · Cited by 2
“14-18 The COSMIN guidelines are widely considered the gold standard for assessing the quality of measurement properties.”
Are we there yet? A systematic review and meta-analysis of the validity and reliability of automated markerless motion capture systems during jumping tasks
Ogura, A., Florio, E., Wileman, T. M., Dennison, L., & Psarakis, M. (2025) · Journal of Sports Sciences · doi:10.1080/02640414.2025.2589689 · Cited by 2
“For reliability and measurement error, we used the COSMIN Risk of Bias tool (Version 1.0, 2020) (Mokkink et al., 2020), which offers updated criteria specifically suited for non-patient-reported outcome measures such as ClinROMs, PerFOMs, and laboratory values.”
Influential
A scoping review of safer mobility behaviour assessment and intervention: implications for people with Parkinson’s disease
Cheung, D., Wesson, J., Paul, S. S., Mackenzie, L. A., Goh, L., Canning, C. G., Almeida, L. R. S., Enright, M., & Allen, N. E. (2025) · Disability and Rehabilitation · doi:10.1080/09638288.2025.2592495 · Cited by 2
Do sex differences influence test habituation and internal data validity in neurocognitive testing? A blinded measurement error analysis
Warneke, K., Oraže, M., Herbsleb, M., Afonso, J. R., & Wallot, S. (2025) · Neuroscience · doi:10.1016/j.neuroscience.2025.12.007 · Cited by 2
Measurement properties of the sit-to-stand test in community-dwelling people with chronic obstructive pulmonary disease: a COSMIN systematic review
Farley, C., Newman, A. N. L., Phillips, S. M., Smith‐Turchyn, J., & Brooks, D. (2025) · Thorax · doi:10.1136/thorax-2025-223967 · Cited by 2

Authors: Mokkink, L. B., Boers, M., van der Vleuten, C. P. M., Bouter, L. M., Alonso, J., Patrick, D. L., de Vet, H. C. W., & Terwee, C. B.
Affiliations: Amsterdam Public Health (NL)
Universitat Pompeu Fabra (ES)
University of Washington (US)
Corresponding author: Mokkink, L. B.
ORCID: Mokkink, L. B.
Boers, M.
Bouter, L. M.
Alonso, J.
Patrick, D. L.
Terwee, C. B.
Venue: BMC Medical Research Methodology
Publisher: Springer Science and Business Media LLC
Published: 2020-12
Volume: 20
Issue: 1
Pages: 293-293
ISSN: 1471-2288 (ISSN-L)
DOI: 10.1186/s12874-020-01179-5
PMC: PMC7712525
OpenAlex: W3107903990
Cited by: 588
References: 31
Citations by year: 2026: 106 · 2025: 121 · 2024: 149 · 2023: 101 · 2022: 72 · 2021: 37 · 2020: 2
FWCI: 32.32
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (tdm)
creativecommons.org/licenses/by/4.0/ (vor, 2 d)
Locations: BMC Medical Research Methodology (publishedVersion, cc-by)
Research Square (acceptedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Research Publications (Maastricht University) (publishedVersion, cc-by)
VU Research Portal (publishedVersion, other-oa)
Pure Amsterdam UMC (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (submittedVersion)
Repositori digital de la UPF (Universitat Pompeu Fabra) (submittedVersion, cc-by)
Research Publications (Maastricht University) (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion)
Funders: Nederlandse Organisatie voor Wetenschappelijk Onderzoek (91617098)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Reliability and Agreement in Measurement
Social Sciences › Sociology and Political Science › Delphi Technique in Research
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords: COSMIN, risk of bias, reliability statistics, measurement error, outcome measurement instruments, clinician-reported outcomes, performance-based outcome measures, laboratory parameters, study quality assessment, Delphi consensus, measurement properties
MeSH terms: Delphi Technique, Humans, Reproducibility of Results, Bias, Consensus

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COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study

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