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    Clinical Outcome Assessments

    What are Clinical Outcome Assessments (COAs)? What do they measure?

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    Mapi Research Trust is a non-profit organization dedicated to improving patients’ quality of life by facilitating access to Clinical Outcome Assessments(COAs).

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  4. Literature Review

Literature Review

Articles

Antonia Morga, Silvia Dibenedetto, Rocco Adiutori & Jun Su. Patient-reported outcomes validated in phase 3 clinical trials: a targeted literature review. Current Medical Research and Opinion. 2023.

Anne-Sophie Michel,  Paul Kamudoni*,  Alexia Marrel,  Rocco Adiutori,  Céline Desvignes-Gleizes,  Sally Lanar,  Peter Schache,  Erica Spies and  Josephine Park. Integrating qualitative interviews in drug development and the use of qualitative evidence in product labelling and health technology assessments: a review. Frontiers in Medicine. Volume 10. 2023.

Vanya M, Watt M, Shahraz S, Kosmas CE, Rhoten S, Costa-Cabral S, Mendivil J, Devercelli G, Weller K. Content validation and psychometric evaluation of the Angioedema Quality of Life Questionnaire for hereditary angioedema. J Patient Rep Outcomes. 2023 Apr 3;7(1):33.

Acquadro C, Conway K, Hareendran A, Aaronson N; European Regulatory Issues and Quality of Life Assessment (ERIQA) Group. Literature Review of Methods to Translate Health-Related Quality of Life Questionnaires for Use in Multinational Clinical Trials. Value Health. 2007 Dec 18; Value Health. 2008 May-Jun;11(3):509-21. Epub 2007 Dec 18. Review.

Zollner YF, Acquadro C, Schaefer M. Literature review of instruments to assess health-related quality of life during and after menopause. Qual Life Res. 2005 Mar;14(2):309-27.

Coons SJ, Rao S, Keininger DL, Hays RD. A comparative review of generic quality of life instruments. PharmacoEconomics 2000;17:13-35.

Posters

Lien S, Desvignes-Gleizes C, Bothorel S, Sherafat-Kazemzadeh R. Enhancing Patient-Centricity in Cardiovascular Outcomes: Exploring Endpoint Strategies With Clinical Outcome Assessments (COA) in Approved Drugs for Chronic Heart Failure. Presented at ISPOR Europe 2024.

Stott T, Desvignes-Gleizes C, Bothorel S, Sherafat-Kazemzadeh R. Identifying Clinical Outcome Assessments (COA), With a Particular Focus on Mental Health Related COA, Mapped to the EQ-5D to Establish Comparable Utility Values for Quality-Adjusted Life Year (QALY) Evaluation. Presented at ISPOR Europe 2024.

Stott T, Lien S, Desvignes-Gleizes C, Bothorel S, Sherafat-Kazemzadeh R. 10 Years on From the FDA’s Women’s Health Research Roadmap: A Landscape Review of Female-Specific Clinical Outcome Assessments (COA), Health Agency Recommendations and Drug Label Claims With COA Related to Women’s Health. Presented at ISPOR Europe 2024.

Mouchet J, Acquadro C, Emery MP, Maier W. Review of all products authorized by the European Medicines Agency from 1995 to 2011 in regard to Pediatric Investigation Plan applications. Presented at the ISPOR 15th Annual European Congress, Berlin, Germany, November 2012.

Rudell K, Thrift-Perry M, Savre I, Perret C, Caron M. Instruments measuring treatment adherence and compliance in Diabetes Mellitus: A literature review. Presented at the ISPOR 17th Annual International Meeting, Washington DC, USA, June 2012.

Bricout H, Maier W, Mouchet J. Epidemiology of Staphylococcus Aureus Infections in Children: A Literature Review of the Last 10 Years. Value in Health. November 2011; 14(7), pA267-A268:PIN13. Presented at ISPOR 14th Annual European Congress, Madrid - Spain, November 2011.

Marquis P, Caron M, Emery M.P, Scott J, Acquadro C. The role of health-related quality of life data in the drug approval processes in the USA and Europe: A review of guidance documents and authorizations of medicinal products from 2006 to 2010. Value in Health. May 2011;14(3):pA28:PHP94. Presented at ISPOR 16th Annual International Meeting, Baltimore – USA, May 2011.

Marant C, Emery MP, Dias-Barbosa C, Swensen A, Staniek V, Arnould B. A disease model illustrating the impact of psoriasis on patient's lives. Presented at the 11th Annual European Meeting of the ISPOR, Athens, Greece, November 2008.

Guillemin I, Lam A, Richarz U, Kavanagh S, Emery MP, Benmedjahed K, Dubois D, Arnould B. Accessing the value of 24-hour chronic pain control from the patient perspective: do existing Patient-Reported Outcome instruments adequately cover the relevant concepts related to 24-hour chronic pain control? Presented at the 11th Annual European Meeting of the ISPOR, Athens, Greece, November 2008.

Staniek V, Williams AE, Emery MP, Marrel A, Dias-Barbosa C. Treatment satisfaction questionnaires in asthma and other chronic diseases. Presented at the 13th Annual International Meeting (ISPOR), Toronto, Ontario, Canada, May 3-7, 2008.

E, Emery MP. A literature review of treatment satisfaction, adherence and HRQL instruments used in type 1 and 2 diabetes. Value in Health, May/June 2006;9(3):A42. Presented at the 11th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Philadelphia, May 2006.

Emery MP, Staniek V. A Literature Review of Patient-reported Outcomes (PROs), Neuropsychological and Cognitive instruments in Parkinson's Disease. Value in Health, November/December 2006;9(6):A377. Presented at the 9th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Copenhagen, October 2006.

Staniek V, Bouin O, Minjoulat-Rey M-C, Emery MP, Arnould B, Prost L, Gabriel S. A Literature Review of Patient-Reported Outcomes (PRO) Used in Atrial Fibrillation. Presented at the 8th Annual European Meeting of the ISPOR, Florence, Italy, November 2005.

Staniek V, Arnould B, Hugonot-Diner L, Garcia Cebrian A, Monz B. Quality of life, emotional and physical symptoms in depression: A literature review of symptomatology and patient-reported outcome (PRO) instruments. Presented at the 10th Annual International Meeting of the ISPOR, Washington DC, May 2005.

Adesina KB, Abetz L, Akhras KS, Emery MP. Responsive health-related quality of life domains in the treatment of hypertension: a systematic review of published studies and measures. Quality of Life Research. 2001;10(3):252. Presented at the 8th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Amsterdam, The Netherlands, November 2001.

Abetz LN, Jones MKC, Adesina K, Emery MP. Quality of life and treatment satisfaction measurement with asthma patients: results from a comprehensive literature review. Value in Health. 2000;3(5):328-329. Presented at the 3rd Annual European Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Antwerp, Belgium, November 2000.

Emery MP, Adesina A, Marquis P, Sagnier PP, Kubin M. Measurement properties of quality of life instruments in erectile dysfunction (ED): a review of published results. Value in Health. 2000;3(2):99. Presented at the 5th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Crystal City, USA, May 2000.

Emery MP, Adesina A, Marquis P, Van Gool R. Psychometric validity of quality of life and utility measures in non-small cell lung cancer (NSCLC): a literature review. Value in Health. 2000;3(2):132. Presented at the 5th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Crystal City, USA, May 2000.

Oral Presentations

Garin O, Ferrer M, Van Ganse E, Petri G, Wiklund I, Mouly M, Romera B, Alonso J. Heart Failure specific Health-Related Quality of Life questionnaires. A systematic review. Quality of Life Research. 2002;11(7):628. Presented at the 9 th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Orlando, USA, November 2002.

Keininger DL. Quality of Life of Older Adults. Presented at the Third Advanced Postgraduate Course, European Academy for Medicine of Ageing. IKB Foundation, Sion, Switzerland. June 2000.

Keininger DL. A review of Available Health-related Quality of Life (HRQL) Reference Values in the medical Literature. Presented at the International Society for Pharmacoeconomics and Outcome Research , Edinburg, Scotland, November 1999.

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