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Browsing by Author "Salek, Mir-Saeed Shayegan"
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Appraisal of patient-reported outcome measures in analogous diseases and recommendations for use in phase II and III clinical trials of pyruvate kinase deficiency
Salek, Mir-Saeed Shayegan; Ionova, Tatyana; Johns, Jeffrey; Oliva, Esther Natalie (2018-11-19)Purpose: Pyruvate kinase deficiency (PKD) is a rare disease and understanding of its epidemiology and associated burden remains limited. With no current curative therapy, clinical manifestations can be life threatening, ... -
The Burden of Disease in Pyruvate Kinase Deficiency: Patients' Perception of the Impact on Health-Related Quality of Life
Grace, RF; Cohen, L; Egan, S; Wells, T; Witherspoon, B; Ryan, A; Salek, Mir-Saeed Shayegan; Bodie, S; Klaassen, RJ (2018-12-01)Objectives: This study explored how signs and symptoms of pyruvate kinase (PK) deficiency, a rare hemolytic anemia caused by mutations in the PKLR gene, impacts patients’ health-related quality of life (HRQoL). Methods: ... -
Correlating the Dermatology Life Quality Index with psychiatric measures: A systematic review.
Ali, FM; Johns, Nutjaree; Salek, Mir-Saeed Shayegan; Finlay, Andrew Y. (2018-11-01)Skin conditions may have a major impact on the psychologic well-being of patients, ranging from depression to anxiety. The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life tool in dermatology, ... -
Determinants of Psychosocial Health in Psoriatic Patients: A Multinational Study
Lesner, Karolina; Reich, Adam; Szepietowski , Jacek C; Dalgard, Florence; Finlay, Andrew Y.; Kupfer, Joerg; Gieler, Uwe; Salek, Mir-Saeed Shayegan (2017-11-01)There are limited data on the differences in the impact of psoriasis between various countries with respect to quality of life (QoL). The aim of this study was to explore the psychosocial health of patients with psoriasis ... -
The Development and Validation of a Generic Instrument, QoDoS, for Assessing the Quality of Decision Making.
Donelan, R; Walker, Stuart; Salek, Mir-Saeed Shayegan (2016-07-13)Introduction: The impact of decision-making during the development and the regulatory review of medicines greatly influences the delivery of new medicinal products. Currently, there is no generic instrument that can be ... -
Establishing the values for patient engagement (PE) in health-related quality of life (HRQoL) research: an international, multiple-stakeholder perspective
Haywood, Kirstie; Lyddiatt, Anne; Brace-McDonnell, Samantha J.; Staniszewska, Sophie; Salek, Mir-Saeed Shayegan (2016-12-08)PurposeActive patient engagement is increasingly viewed as essential to ensuring that patient-driven perspectives are considered throughout the research process. However, guidance for patient engagement (PE) in HRQoL ... -
Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment : A Systematic Review of the Literature.
Bujar, M; McAuslane, N; Walker, S; Salek, Mir-Saeed Shayegan (2017-04-10)Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better ... -
Factors influencing delays in patient access to new medicines in Canada: a retrospective study of reimbursement processes in public drug plans
Salek, Mir-Saeed Shayegan; Hoskyn, Sarah Lussier; Johns, Jeffrey; Allen, Nicola; Sehgal, Chander (2019-03-29)Individuals who rely on public health payers to access new medicines can access fewer innovative medicines and must wait longer in Canada compared to major markets around the world. New medicines/indications approved by ... -
Impairment of Sexual Life in 3,485 Dermatological Outpatients From a Multicentre Study in 13 European Countries
Sampogna, Francesca; Abeni, D; Gieler, Uwe; Tomas-Aragones, Lucia; Titeca, Géraldine; Lien, Lars; Salek, Mir-Saeed Shayegan (2016-11-06)Skin conditions may have a strong impact on patients' sexual life, and thus influence personal relationships. Sexual issues are difficult to discuss directly in clinical practice, and a mediated instrument may be useful ... -
Occurrence, Chronicity and Intensity of Itch in a Clinical Consecutive Sample of Patients with Skin Diseases: a Multi-centre Study in 13 European Countries
Schut, Christina; Dalgard, F J; Halvorsen, Jon Anders; Gieler, Uwe; Lien, Lars; Tomás-Aragonés, L; Poot, Francoise; Jemec, Gregor B.E.; Misery, Laurent; Kemeny, L; Sampogna, Francesca; Van Middendorp, Henriët; Balieva, Flora; Linder, Dennis; Szepietowski , Jacek C; Lvov, A; Marron, SE; Altunay, Ilknur K.; Finlay, Andrew Y.; Salek, Mir-Saeed Shayegan; Kupfer, Joerg (2018-09-18)Itch is an unpleasant symptom, affecting many dermatological patients. Studies investigating the occurrence and intensity of itch in dermatological patients often focus on a single skin disease and omit a control group ... -
Pan-Canadian Pharmaceutical Alliance (pCPA): Timelines Analysis and Policy Implications
Salek, Mir-Saeed Shayegan; Hoskyn, Sarah Lussier; Johns, Jeffrey; Allen, Nicola; Sehgal, Chander (2019-02-18)This analysis follows our recent study showing that Canadian public reimbursement delays have lengthened from regulatory approval to listing decisions by public drug plans and delayed public access to innovative medicines, ... -
Paper and electronic versions of HM-PRO, a novel patient-reported outcome measure for hematology: an equivalence study.
Goswami, Pushpendra; Oliva, Esther; Ionova, Tatyana; Else, R; Kell, J; Fielding, AK; Jennings, DM; Karakantza , M; Al-Ismail, S; Lyness, J; Collins, GP; McConnell , S; Langton, C; Al-Obaidi, MJ; Oblak, M; Salek, Mir-Saeed Shayegan (2019-04-30)Aim:To determine measurement equivalence of paper and electronic application of the hematologi-cal malignancy-patient-reported outcome (HM-PRO), a specific measure for the evaluation of patient-reported outcomes in ... -
Patient-centered research and practice in the era of genomics: a novel approach
Salek, Mir-Saeed Shayegan; Oliva, Esther; Ionova, Tatyana (2016-07) -
A practical approach to communicating benefit-risk decisions of medicines to stakeholders.
Leong, J; Walker, S; Salek, Mir-Saeed Shayegan (2015-06-11)Purpose: The importance of a framework for a systematic structured assessment of the benefits and risks has been established, but in addition, it is necessary that the benefit-risk decisions and the processes to derive ... -
Presenting signs and patient co-variables in Gaucher disease : outcome of the Gaucher Earlier Diagnosis Consensus (GED-C) Delphi initiative
Mehta, Atul; Kuter, David; Salek, Mir-Saeed Shayegan; Belmatoug , N; Bembi , B; Bright, J; Vom Dahl, S; Deodato, F; Di Rocco, M; Goker-Alpan, O; Hughes, DA; Lukina, EA; Machaczka, M; Mengel, E; Nagral, A; Nakamura, K; Narita, A; Oliveri , B; Pastores, G; Pérez-López, J; Ramaswami, U; Schwartz, IV; Szer, J; Weinreb, NJ; Zimran, A (2019-05-01)Background: Gaucher disease (GD) presents with a range of signs and symptoms. Physicians can fail to recognise the early stages of GD owing to a lack of disease awareness, which can lead to significant diagnostic delays ... -
The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries.
Dalgard, Florence; Gieler, Uwe; Tomas-Aragones, Lucia; Lien, Lars; Poot, Francoise; Jemec, Gregor B.E.; Misery, Laurent; Szabó, Csanád; Linder, D; Sampogna, Francesca; Evers, A W M; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek C.; Romanov, Dmitry; Marron, SE; Altunay, Ilknur K.; Finlay, Andrew Y.; Salek, Mir-Saeed Shayegan; Kupfer, Joerg (2015-04-01)The contribution of psychological disorders to the burden of skin disease has been poorly explored, and this is a large-scale study to ascertain the association between depression, anxiety, and suicidal ideation with various ... -
Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines
Rahalkar, Hasumati; Cetintas, Hacer Coskun; Salek, Mir-Saeed Shayegan (2018-09-28)Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations ... -
The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.
Keyter, A; Gouws, J; Salek, Mir-Saeed Shayegan; Walker, S (2018-07-01)BACKGROUND: The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, ... -
The Role of Therapy in Impairing Quality of Life in Dermatological Patients: A Multinational Study
Balieva, Flora; Finlay, Andrew Y.; Kupfer, Joerg; Tomas-Aragones, Lucia; Lien, Lars; Gieler, Uwe; Poot, Francoise; Jemec, Gregor B.E.; Misery, Laurent; Kemeny, L; Sampogna, Francesca; Van Middendorp, Henriët; Halvorsen, Jon Anders; Ternowitz, T; Szepietowski, Jacek C.; Potekaev, N; Marron, SE; Altunay, Ilknur K.; Salek, Mir-Saeed Shayegan; Dalgard, Florence (2018-06-08)Skin disease and its therapy affect health-related quality of life (HRQoL). The aim of this study was to measure the burden caused by dermatological therapy in 3,846 patients from 13 European countries. Adult outpatients ... -
The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland
Keyter, Andrea; Salek, Mir-Saeed Shayegan; Banoo, Shabir; Walker, Stuart R. (2019-03-14)Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas ...