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  • 1.
    Cano, Stefan
    et al.
    Modus Outcomes, UK.
    Pendrill, Leslie
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Melin, Jeanette
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Fisher, William
    University of California, US.
    Towards consensus measurement standards for patient-centered outcomes2019Inngår i: Measurement, Vol. 141, s. 62-69Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Patient centered outcomes pertain to a patient's beliefs, opinions and needs in conjunction with a clinician's medical expertise and assessment. The rise of patient-centered outcome (PCO) measurement parallels increased interest in patient-centered care. PCO measures offer the opportunity for more meaningful measurement of health outcomes informative enough to guide treatment decisions. However, it has been suggested that, for practical and scientific reasons, existing PCO measures are currently not capable of delivering the kind of quality assured measurement required for high-stakes decision making. Potential solutions include: addressing the lack of units in PCO measurement through recourse to mathematical models devised to define meaningful, invariant, and additive units of measurement with known uncertainties; establishing coordinated international networks of key stakeholders guided by five principles (i.e., collaboration, alignment, integration, innovation and communication); better use of technology leveraging measurement through item banks linking PCO reports via common items, common patients, or specification equations based in strong explanatory theory. And finally ensuring PCO measurement always is associated with: (1) a clear definition of the measurand in regards to the intended clinical use; (2) a clear definition of the clinically allowable error of measurement; (3) international cooperation and consensus to navigate the complexities of the development of metrologically sound reference measurement systems; and (4) continued clinical validation of newly calibrated measures. In this article, we illustrate the principles to improve PCO measures with examples from breast cancer, vision-related patient-reported outcome measures, and dementia clinician-reported and performance outcome measures.

  • 2.
    Melin, Jeanette
    et al.
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Fornazar, Robin
    University of Gothenburg, Sweden.
    Spångfors, Martin
    Lund University, Sweden; Kristianstad Hospital, Sweden.
    Pendrill, Leslie
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Rasch analysis of the Patient Participation in Rehabilitation Questionnaire (PPRQ)2019Inngår i: Journal of Evaluation In Clinical Practice, ISSN 1356-1294, E-ISSN 1365-2753Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Objective: To evaluate the Patient Participation in Rehabilitation Questionnaire (PPRQ) according to Rasch measurement theory. Method: Five hundred twenty-two post-discharge patients from a neurological rehabilitation unit were included. The PPRQ questionnaire comprises 20 items rated by a cohort of 522 patients about their experiences of participating in rehabilitation. The measurement properties of the PPRQ were evaluated by Rasch analysis of the responses. Results: The Rasch analysis of 20 items showed some major misfits, particularly three items addressing the involvement of family members. After removing those items, the model fit improved and no significant DIF remained. Despite improvements, person values (−2.96 to 4.86 logits) were not fully matched by the item values (−0.61 to 0.77 logits). Neither did the t test for unidimensionality meet the criterion of 5%, and local dependency was present. The unidimensionality and local dependency could, however, be accommodated for by four testlets. Conclusion: The PPRQ-17 showed that a ruler with a reasonable and clinical hierarchy can be constructed, although the expectations of dimensionality and local dependency need to be evaluated further. Despite room for further development, PPRQ-17 nevertheless shows improved measurement precision in terms of patient leniency compared with previous evaluations with classical test theory. In turn, this can play a crucial role when comparing different rehabilitation programs and planning tailored care development activities.

  • 3.
    Melin, Jeanette
    et al.
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik. University of Gothenburg, Sweden.
    Nordin, Åsa
    University of Gothenburg, Sweden.
    Feldthusen, Caroline
    University of Gothenburg, Sweden.
    Danielsson, Louise
    University of Gothenburg, Sweden; Angered hospital, Sweden.
    Goal-setting in physiotherapy: exploring a person-centered perspective.2019Inngår i: Physiotherapy Theory and Practice, ISSN 0959-3985, E-ISSN 1532-5040Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    Objective: To analyze definitions and related requirements, processes, and operationalization of person-centered goal-setting in the physiotherapy research literature; to discuss those findings in relation to underlying principles of person-centeredness; and to provide an initial framework for how person-centered goal-setting could be conceptualized and operationalized in physiotherapy. Methods: A literature search was conducted in the databases: CINAHL, PubMed, PEDro, PsycINFO, REHABdata and Scopus. A content analysis was performed on how person-centered goal-setting was described. Results: A total of 21 articles were included in the content analysis. Five categories were identified: 1) Understanding goals that are meaningful to the patients; 2) Setting goals in collaboration; 3) Facing challenges with person-centered goal-setting; 4) Developing skills by experiences and education; and 5) Changing interaction and reflective practice. These categories were abstracted into two higher-ordered interlaced themes: 1) To seek mutual understanding of what is meaningful to the patient; and 2) To refine physiotherapy interaction skills, which we suggest would be useful for further conceptualization. Conclusion: In this analysis, we interpreted person-centered goal-setting in physiotherapy as a process of interaction toward a mutual understanding of what is meaningful to the patient. Future research may explore how to integrate mindful listening, embodied interaction and continuous ethical reflection with different assessments and treatment methods.

  • 4.
    Melin, Jeanette
    et al.
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Pendrill, Leslie
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Quality assurance of cognitive assessments and other categorical data2019Konferansepaper (Annet vitenskapelig)
    Abstract [en]

    Did you ever wonder how to account for biases such as ceiling eects in your (cognitive) data?

    Metrological quality assurance of human-based responses is in its infancy and analyzing categorial data and other human responses is challenging. However, there is a need to tackle those challenges to ensure that decisions about health care are made correctly. Quality assured comparability, interoperability and decision-making can successfully be done by applying sound metrological approaches to enable traceability as well as stressing declaration of measurement uncertainties. In the seminar, we present metrological approaches to ensure quality assurance of categorical data,such as cognitive assessments and other human-reported responses. This is followed by a hands-onworkshop where you are welcome to bring your own or freely available data for analyses.

  • 5.
    Melin, Jeanette
    et al.
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Pendrill, Leslie
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Cano, Stefan
    Modus Outcome, Uk.
    NeuroMET Memory Metric version 0.12019Konferansepaper (Annet vitenskapelig)
    Abstract [en]

    Alongside a lack clinically validated, minimally invasive diagnostic tools for early diagnosis and/or monitoring of disease progression in Alzheimer’s Disease (AD), there are no sound metrological assessment protocols and measurements for cognition, nor measurement comparability through SI (System of International Units), traceability and uncertainty for regulatory approval of biomarkers. As part of the on-going EMPIR HLT04 NeuroMET project in which several national metrology institutes work together with clinicians and academics to overcome specific measurement issues to improve diagnosis and disease progression, we describe here the justification for and development of the ‘NeuroMET Memory Metric’ (version 0.1).

    Re-examination of traditional widely used ‘legacy’ cognitive assessment protocols using invariant measurement theory aims at more accurately capturing the patient’s cognitive ability and improving the analysis of correlations with various AD biomarkers. Two principal elements provide sound metrological underpinnings: (i) a correct formulation of a measurement model; and (ii) proper handling of the ordinal cognitive data. In turn, this enables formulation of novel construct specification equations for patient cognitive ability as a function of diverse biomarkers (e.g., in plasma, CSF and saliva together with MRI/MRS data) as well as for cognitive task difficult as a function of test design.

    To further improve the accuracy in patient’s cognitive ability work is now in progress to develop a NeuroMET Memory Metric based on legacy cognitive assessments (e.g., MMSE, Corsi Block Test, Digital Span Test). This work can be ascribed a level-5 construct theory. This means the realization of more fit-for-purpose, better targeted and better administered cognitive measurement systems. It will also enable traceable calibration of both additional cognitive tasks as well as the effects of intervention (or disease progression) on the cognitive ability of each individual patient.

  • 6. NeuroMET constorium, EMPIR HLT04
    et al.
    Melin, Jeanette
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Pendrill, Leslie
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Innovative measurements for improved diagnosis and management of neurodegenerative diseases2019Konferansepaper (Annet vitenskapelig)
    Abstract [en]

    Development of novel therapies for Alzheimer’s Disease (AD) is constrained by the lack of available methods for preclinical diagnosis, despite extensive research on biomarker identification. The EMPIR NeuroMET project unites National Measurement Laboratories, clinicians and academics, to overcome limitations in measurement methods and provide a better understanding of how to improve, combine and analyse measurements in AD diagnosis and treatment. Comparability through SI (System of International Units) traceability and uncertainty analysis is an, as yet, unmet requirement for regulatory approval of biomarkers, patient centred outcome measures, clinical thresholds and new therapeutic drugs. We will report on:

    • Multimodal statistical analysis on blood, CSF and saliva biomarkers data from the NeuroMET cohort generated by using mass spectroscopy and immunoassay platforms, including a novel immunoassay approach to overcome matrix effects when relative quantification is not sensitive enough. A new digital PCR approach was developed to assess microRNAs quantities in blood to compare with established biomarkers.
    • Progress towards the development of mass spectrometry reference measurement procedures traceable to the SI for t-tau and α-synuclein in cerebrospinal fluids.
    • Development of ultrahigh field Magnetic Resonance Imaging and Spectroscopy protocols for increased spatial and spectral resolution and decreased uncertainty, and their application to the NeuroMET cohort.
    • Improved cognitive assessment protocols, with improved metrological evaluation of cognitive performance scores and the development of construct specification equations for various cognitive protocols and biomarkers.
    • Potential relationships between volumes of AD-related brain structures and neurometabolite concentrations with measured cognitive function.

    Improved reference methods to underpin the production of calibrators and improve measurement comparability of established biomarkers has the potential to further the understanding of AD and boost research for disease modifying therapies.

  • 7.
    Pendrill, Leslie
    et al.
    RISE - Research Institutes of Sweden.
    Cano, Stefan
    Modus Outcomes plc, UK.
    Kobe, Theresa
    Charité - University Medicine Berlin, Germany.
    Melin, Jeanette
    Fillmer, Ariane
    Physikalisch-Technische Bundesanstalt, Germany.
    Restitution of ability and difficulty from decision-making: The metrology of human-based perceptions2018Inngår i: Measurement at the Crossroads: History,philosophy and sociology of measurement, Paris, 2018Konferansepaper (Fagfellevurdert)
    Abstract [en]

    Fundamental reappraisal of metrology, beyond superficial analogies with traditional measurement instruments, is needed if ordinal properties – such as ‘counted fractions’ (bounded by zero and one), performance metrics for ability tests, customer satisfaction, etc - are to be included in an extended quantity calculus for a new SI. Regarding a human being (or other ‘probe’) as a Measurement Instrument with Rasch measurement theory (i.e., postulating a Generalised Linear Model link function z = θ – δ, of a ‘probe’ attribute θ and a ‘target’ attribute δ) not only handles ordinal properties of the measurement system response, Psuccess, but also attribute separability in restitution; essential to underpinning measurement traceability and uncertainty. Examples from person-centred care (e.g., of Alzheimer ’s disease patients) will demonstrate causal Rasch models relating task difficulty and patient ability to explanatory variables such as test sequence entropy and brain atrophy, thereby enabling novel certified reference materials for traceability.

  • 8.
    Pendrill, Leslie
    et al.
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Melin, Jeanette
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Measuring counted fractions in healthcare2019Inngår i: TMQ Techniques, Methodologies and Quality, ISSN 2183-0940, nr NÚMERO ESPECIAL, s. 60-69Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    In establishing metrological quality assurance in healthcare, one major hurdle is the correct treatment ofordinal data typical of questionnaires, performance tests and other categorical data collected widely in care.Despite being known well over a century, there are still many examples of measurements in healthcare – forexample, (i) on-line tables of percentage performance indicators (e.g. fraction of patients seeing a doctorwithin seven days) and (ii) correlation plots for Alzheimer sufferers of cognitive scores against biomarkerconcentration – where the ‘counted fraction’ distortion of scales is not compensated for. The Rasch form ofgeneralised linear model not only handles counted fraction ordinality but also enables separation of objectand instrument attributes (such as task difficulty and patient ability) essential for metrological restitutionin measurement systems in healthcare. A perspective is given of a new kind of certified reference materialemploying causal Rasch models in terms of construct specification equations for metrological item bankingin the social sciences. This is part of the response to a recent call for: ‘a new international body to bringtogether metrology, psychometrics, philosophy, and clinical management to support the global comparabilityand equivalence of measurement results in patient centred outcome measurement to improve healthcare’.

  • 9.
    Pendrill, Leslie
    et al.
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Quaglia, Milena
    Laboratory of the Government Chemist Limited, UK.
    Cano, Stefan
    Modus Outcomes, UK.
    Melin, Jeanette
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Innovative measurements forimproved diagnosis and management of neurodegenerative diseases – EMPIRNeuroMet 15HLT042017Konferansepaper (Fagfellevurdert)
    Abstract [en]

    Background: Neurodegeneration is an incurable, debilitating process which presents a growing medical and economic challenge due to our aging population. Alzheimer’s disease is one of the most common neurodegenerative diseases. Objectives: Currently, there are no minimally invasive diagnostic tools which allow for early diagnosis or monitoring of the progression of disease in patients. Methods: The European EMPIR NeuroMet 15HLT04 project (2016 – 9) is helping to address these objectives by exploring innovative techniques for early diagnosis and monitoring, based on non-invasive magnetic resonance imaging approaches, and developing improved clinical assessment protocols focused on monitoring declining cognitive functions. Results: As a case study, the person-centred measurement of cognitive ability is examined, where better analysis of correlations with brain atrophy is enabled thanks to the Rasch metrological approach. A new model of the metrology of ordinal data, including performance metrics and restitution is presented. Conclusions: An example is given of how the Rasch invariant measure theory can improve contemporary studies of possible correlations between neurodegeneration in patients suffering from Alzheimer’s disease – specifically failing cognitive ability – and brain atrophy. It is the first time to our knowledge that the known distortions - revealed by the Rasch psychometric model - of measurement scales in common clinical instruments for cognitive assessment have been corrected for in correlation studies. Possibilities of higher resolution and more reliable clinical decisions open up. Acknowledgments The European Metrology Programme for Innovation & Research (EMPIR, Horizon2020, Art. 185) is jointly funded by the EMPIR participating countries within EURAMET (www.euramet.org) and the European Union in this EMPIR 15 HLT04 NeuroMet project (coordinator: LGC (UK)). Thanks are due, particularly, to Members of the EMPIR NeuroMet consortium. PROJECT WEBSITE http://www.lgcgroup.com/our-science/national-measurement-laboratory/european-metrology-programme-for-innovation-and-re/neuromet/#.WRHEO2dYrcs

  • 10.
    Quaglia, Milena
    et al.
    LGC, UK.
    Bellotti, Vittorio
    University College London, UK.
    Cano, Stefan
    Modus Outcomes, UK.
    Cyrar, Adam
    LGC, UK.
    Deane, Katherine
    University East Anglia, UK.
    Divieto, Carla
    Istituto Nazionale di Ricerca Metrologica, Italy.
    Fillmer, Ariane
    PTB Physikalisch-Technische Bundesanstalt, Germany.
    Giangrande, Chiara
    Laboratoire National de Métrologie et d'Essais, France.
    Köbe, Theresa
    Humboldt-Universität zu Berlin, Germany ; Berlin Institute of Health, Germany.
    Lehmann, Sylvain
    CHU Montpellier, France.
    Melin, Jeanette
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    Pang, Susan
    LGC, UK.
    Parkes, Helen
    LGC, UK.
    Pendrill, Leslie
    RISE - Research Institutes of Sweden, Säkerhet och transport, Mätteknik.
    BETTER MEASUREMENT FOR IMPROVED DIAGNOSIS AND MANAGEMENT OF ALZHEIMER’S DISEASE: UPDATE ON THE EMPIR NEUROMET PROJECT2018Inngår i: Alzheimer's & Dementia, ISSN 1552-5260, E-ISSN 1552-5279, Vol. 14, s. P759-P760, artikkel-id 7Artikkel i tidsskrift (Annet vitenskapelig)
    Abstract [en]

    The development of novel therapies for Alzheimer’s Disease (AD) is constrained by the lack of available methods for preclinical diagnosis, despite extensive research on biomarker identification. Here, we present an update of progress from EMPIR NeuroMET, a project combining diverse expertise from five National Measurement Institutes (NMIs), with clinicians and academics, to overcome limitations in measurement methods in neurodegenerative disease diagnosis and treatment.

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