Content validity–establishing and reporting the evidence in newly developed patient‐reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1 – eliciting concepts for a new PRO instrument

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1. Cappelleri JC, Zou KH, Bushmakin AG, Alvir JMJ, Alemayehu D, Symonds T: Patient-reported outcomes, measurement, implementation and interpretation
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3. Marketing Strategies to Increase Profits from Retailing Fair Trade Coffee
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4. Adding Disease-Specific Concerns to Patient-Reported Outcome Measures
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6. Importance of Patient-Reported Outcome Measures on Clinical Practice in Patients With Kidney Disease
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7. The Use of Patient Reported Outcome Measures and Experiences in Patients With Anaemia Receiving Intravenous Ferric Carboxymaltose: A Cohort Study
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8. Face and content validity of the EMPOWER-UP questionnaire: a generic measure of empowerment in relational decision-making and problem-solving
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9. Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval
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10. Peer Reviewed Title: Overview of classical test theory and item response theory for the quantitative assessment of items in developing patient-reported outcomes measures
    JC Jason Lundy, Judith C. Hays · 2014
11. Patient Reported Outcomes in Clinical Trials and Practice with Older Patients
    Sven Stegemann · 2016 · AAPS advances in the pharmaceutical sciences series
12. Overview of Phase III Clinical Trials
    Naitee Ting, Ding‐Geng Chen, Shuyen Ho, Joseph C. Cappelleri · 2017 · ICSA book series in statistics
13. Can a patient reported outcome be adequate without assessing quality of life in lower urinary tract dysfunction?
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14. Towards improving measurement of stiffness in rheumatology
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15. Focusing on the Patient in Drug Development and
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16. Reply to Bora Lee and Jae Heon Kim's Letter to the Editor re: Alan D. Uren, Nikki Cotterill, Christopher Harding, et al. Qualitative Exploration of the Patient Experience of Underactive Bladder. Eur Urol 2017;72:402–7
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17. Approaches to the Development and Use of PRO Measures: A New Roadmap
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18. Innovations in patient-centered breast cancer research
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19. Promoting Financial Management Activities After An Acquired Brain Injury: Enhancing Assessment Evidence
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20. Patient Perspectives brought to the Fore for Diabetes Care : Descriptions as well as Development and Testing of the Diabetes Questionnaire
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21. Good practice in dermatological patient‐reported outcome measure development: an example from localized scleroderma
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22. Optimizing the Assessment of Co-Morbidities in Psoriatic Disease Using Patient-Reported Outcome Measures
    Lourdes Maria Perez-Chada · 2018 · Digital Access to Scholarship at Harvard (DASH) (Harvard University)
23. Integration of Patient Reported Outcomes in Pharmaceutical Drug Development For Prostate Cancer – Focus on the Patient
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24. Development and validation of a quality of life instrument for patients with oral potentially malignant disorders: studies of impact in a population of Telugu speaking adults
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25. Pre-test Assessment of Urinary Dysfunction, Using Patient-Centred Questionnaires
    Nikki Cotterill · 2020 · Cambridge University Press eBooks
26. TABS: The Development and Testing of a Nicotine and Tobacco Use Research Tool
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27. Patient Centered Outcome Research in the Field of Pain
    Ulrike Kaiser, Kathrin Schnabel, Esther Miriam Pogatzki-Zahn · 2020 · Elsevier eBooks
28. Qualitative Findings on the Impact of Disease in Epstein–Barr Virus-Driven Post-Transplant Lymphoproliferative Disease Patients, as Measured by EQ-5D, SF-36, and the FACT-LYM
    Crystal Watson, Arie Barlev, Jason C. Cole, Bhumi Trivedi · 2020 · Oncology and Therapy
29. Urinary Incontinence and Voiding Dysfunction: Patient-Reported Outcome Assessment
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30. Reply to: Revisiting the Functional Status Scale of the Boston Carpal Tunnel Questionnaire, a comment concerning the use of digital communication technology
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31. 口唇口蓋裂患者のQOLを含めた患者報告アウトカムを計測する質問紙「CLEFT-Q」日本語版の作成
    信 彦坂, 剛 金子, 祥行 馬場, 裕子 佐藤 · 2021 · 日本口蓋裂学会雑誌
32. Patient Experience with Treatment of Relapsed or Refractory Multiple Myeloma (RRMM): Content Validity of the Satisfaction and Experience Questionnaire (SEQ)-MM
    Anne M. Skalicky, Emre Yücel, Olabimpe Ruth Eseyin, Aylin Yücel, Sumeet S. Panjabi · 2021 · Research Square
33. Parent-reported outcomes tool for evaluating swallowing dysfunction in otherwise healthy infants and toddlers: Development and Validation
    Abdulsalam Baqays · 2020 · ERA: Education and Research Archive (University of Alberta)
34. Patient-Reported Outcome Data
    Robert O. Morgan, Kavita Sail, Laura E. Witte · 2019 · Health informatics
35. Sleep and Its Importance for Health-Related Quality of Life in 3–10-Year-Old Children
    Anna Lena Sundell, Charlotte Angelhoff · 2020
36. Interpretación y evaluación de las propiedades de medición de los cuestionarios contestados por los pacientes
    Agles Cruz-Peralta, Valentín Herrera-Alarcón · 2022 · Alergia, Asma e Inmunología Pediátricas
37. Improving Reporting on Qualitative Methods Used in the Development and Validation of Patient-Reported Outcome Measures for Mental Health Concerns
    Vanessa Samuel, Ravia Arora, Punit Virk · 2022 · Journal of Psychosocial Nursing and Mental Health Services
38. Introduction
    Andrew G. Bushmakin, Joseph C. Cappelleri · 2022
39. Response to “Letter to the Editor” from Lode Dewulf and Jim Elliott
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40. THE EFFECT OF USING CLUSTERING TECHNIQUE ON STUDENTS’ ABILITY IN WRITING RECOUNT TEXT ON THE X CLASS OF SMA SWASTA DARUL IMAN IN ACADEMIC YEAR 2021/2022
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41. Versorgungsqualität bei obstruktiver Schlafapnoe
    Marcel Braun, Sarah Dietz-Terjung, Christoph Schöbel · 2023 · Pneumo News
42. Facilitators and barriers to eliciting physical function goals before and after surgery: A qualitative study with clinicians
    Theresa Coles, Laura S. Mkumba, Leslie Zapata Leiva, Kate Plyler, Shelley R. McDonald, Sandhya A. Lagoo‐Deenadayalan, Bryce B. Reeve · 2023 · Patient Education and Counseling
43. Study Protocol for the Development and Validation of a People Perceived Quality of Health Systems Scale Based on the People's Voice Survey
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44. Evaluating Pharmacological and Rehabilitation Strategies for Effective Management of Bipolar Disorder: A Comprehensive Clinical Study
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45. RELATIONSHIP AND REFLECTIONS ON QUALITY OF LIFE IN THE TREATMENT OF CHRONIC PAIN IN MILITARY POLICE: Patient-Expected Results (PRO)
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46. Outcome Measures in Limb Lengthening and Deformity Correction
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47. Evaluating Medical Devices in Nephrology Using Patient-Reported Outcome and Experience Measures
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48. A questionnaire based study to assess the challenges faced by clinicians and patients in the management of uveitis
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49. Perspectives of university students as co-designers of a whole-of-university SMS wellbeing check
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50. Content Validity Assessment of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Among Adults with Insomnia and Nocturia
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51. Initial Psychometric Evaluation of the Barth Syndrome Symptom Assessment (BTHS-SA) for Adolescents and Adults in a Phase 2 Clinical Study
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52. Psychometric Validation of the FACE ‐Q Dental Module in Patients With Malocclusions
    Ali Tassi, Anne F. Klassen, Jessica L. Li, Karen W. Y. Wong Riff, Charlene S. Rae · 2025 · Community Dentistry And Oral Epidemiology
53. Patient-Reported Outcome Measures in Surgery: Development, Selection, and Evaluation
    Manraj Nirmal Kaur, Lucas Gallo, Anne F. Klassen, Andrea L. Pusic · 2025 · Springer eBooks
54. Exploring the patient experience of chronic hepatitis D (CHD) and assessment of content validity of the Hepatitis Quality of Life Questionnaire and (HQLQv2) and the Fatigue Severity Scale (FSS)
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55. Development of the Pediatric Weight Questionnaire (PWQ™) for Children and Adolescents with Obesity
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56. Psychometric evaluation of the Adelphi Adherence Questionnaire ( ADAQ ©) in a type 2 diabetes mellitus population as a new measure of adherence and the complex factors influencing adherence in routine care
    Jan Štochl, Nathan A. Clarke, Daniel Green, Jonathan D. Comins, Victoria Higgins, James Piercy, Rob Arbuckle, Tariq Halasa, Thaís Japiassu Cavalcanti Mariano da Rocha, Kamlesh K. Khunti · 2025 · Diabetes Obesity and Metabolism
57. A Qualitative Study on Patient Experience with Signs, Symptoms, and Daily Impacts of Immune Thrombocytopenia
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58. 169 - Rethinking Bowel Health: Adaptation of design of IMPACT Bowel Function Assessment Tool, Short Form for rural Southern Indian population
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59. Cost‐Effectiveness Analysis of First‐Line Chemotherapy for Metastatic Pancreatic Cancer in Japan
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60. Development and validation of the Delirium Burden Scale for Healthcare Providers (DBS‐HCP)
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61. Adaptation of the urticaria patient daily diary for caregiver completion in pediatric chronic spontaneous urticaria
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62. Exploring patient-reported outcome measures to assess symptoms of moderately-to-severely active Crohn’s disease in adult and adolescent patients: a qualitative study
    Theresa M. Hunter, Katherine Kosa, Bonita Basnyat, Susan A. Martin, Richard Moses, Payal Jha, Marla Cindy Dubinsky · 2025 · Journal of Patient-Reported Outcomes
63. Evaluating the Content Validity of the Modified Neuropathy Total Symptom Score-6 Self-Administered (mNTSS-6-SA) in a Painful Diabetic Peripheral Neuropathy Population
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64. Full-spectrum cannabis extracts for women with chronic pain syndromes: a real-life retrospective report of multi-symptomatic benefits after treatment with individually tailored dosage schemes
    Patrícia Montagner Soares Silva, Wesley Medeiros, Clarissa Nogueira Borges, Joaquim Pereira Brasil-Neto, Wilson Lessa, Ricardo Ferreira de Oliveira e Silva, Fábio Viegas Caixeta, Renato Malcher‐Lopes · 2025 · Frontiers in Pharmacology
65. Beyond diagnostic test performance: two content-validated questionnaires assessing patient and clinician satisfaction with diagnostic tests
    Susan Chang, Elizabeth Exall, Caleb Dixon, Georgina Tickler, Muhammad Mamdani, Richard M. Body, Louis Kuritzky, Vivian Ng, A. Joy Allen, Zune Huynh et al. · 2025 · Journal of Patient-Reported Outcomes
66. The patient reported intraocular lens questionnaire (PR-ILQ): content validity, psychometric performance, and use in a regulated clinical trial to evaluate safety and effectiveness outcomes
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67. Additional file 1 of Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures
    Diane M. Turner‐Bowker, An Haack, Kristina, Meaghan Krohe, Andrew Yaworsky, Norma Vivas, Masami Kelly, Godhuli Chatterjee, Emily Chaston, Mann, Erin, Reaney, Matthew · 2020 · Figshare
68. Additional file 1 of Development of symptom-focused outcome measures for advanced and indolent systemic mastocytosis: the AdvSM-SAF and ISM-SAF©
    Taylor, Fiona, Cem Akin, Roger E. Lamoureux, Padilla, Brad, Tanya Green, Anthony L. Boral, Iyar Mazar, Brenton G. Mar, Alan L. Shields, Frank Siebenhaar · 2021 · Figshare
69. Additional file 4 of Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures
    Diane M. Turner‐Bowker, An Haack, Kristina, Meaghan Krohe, Andrew Yaworsky, Norma Vivas, Kelly, Masami, Godhuli Chatterjee, Emily Chaston, Mann, Erin, Reaney, Matthew · 2020 · Figshare
70. Additional file 1 of Establishing content-validity of a disease-specific health-related quality of life instrument for patients with chronic hypersensitivity pneumonitis
    Kerri I. Aronson, Maha Ali, Evgeniya Reshetynak, Kaner, Robert J., Fernando J. Martínez, Safford, Monika M., Pinheiro, Laura C. · 2021 · Figshare
71. Additional file 6 of Effectiveness of expiratory technique and induced sputum in obtaining good quality sputum from patients acutely hospitalized with suspected lower respiratory tract infection: a statistical analysis plan for a randomized controlled trial
    Mariana Bichuette Cartuliares, Helene Skjøt‐Arkil, Flemming Schønning Rosenvinge, Christian Backer Mogensen, Thor Aage Skovsted, Pedersen, Andreas Kristian · 2021 · Figshare
72. Additional file 2 of Patient experience of spontaneous intracranial hypotension (SIH): qualitative interviews for concept elicitation
    Amrhein, Timothy J., Molly McFatrich, Kate Ehle, Michael D. Malinzak, Linda L. Gray, Peter George Kranz, Erin Hope Weant, Christina K. Zigler · 2024 · Figshare
73. Additional file 7 of Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures
    Diane M. Turner‐Bowker, An Haack, Kristina, Meaghan Krohe, Andrew Yaworsky, Norma Vivas, Kelly, Masami, Godhuli Chatterjee, Emily Chaston, Mann, Erin, Reaney, Matthew · 2020 · Figshare
74. Additional file 1 of Qualitative interviews to evaluate content validity of the ACTIV-2 COVID-19 Symptom Diary (ACSD)
    Louis S. Matza, Katie D. Stewart, April N. Naegeli, Mills, Kayla M., Karin S. Coyne, Kara W Chew, Michael D. Hughes, Smith, Davey M. · 2024 · Figshare
75. Additional file 1 of Psychometric evaluation of the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF©) and determination of a threshold score for moderate symptoms
    Alan L. Shields, Taylor, Fiona, Roger E. Lamoureux, Brad Padilla, Kas Severson, Tanya Green, Anthony L. Boral, Cem Akin, Frank Siebenhaar, Brenton G. Mar · 2024 · Figshare
76. Additional file 1 of Development of a new patient-reported outcome measure for complex cryptoglandular fistulas (20-Item complex cryptoglandular fistula questionnaire™): a qualitative study
    Jeffrey D. McCurdy, Patrick Crooks, Chad J. Gwaltney, Robert N. Krupnick, Cadogan, Kathy-Ann, Chitra K. Karki · 2024 · Figshare
77. Additional file 3 of Effectiveness of expiratory technique and induced sputum in obtaining good quality sputum from patients acutely hospitalized with suspected lower respiratory tract infection: a statistical analysis plan for a randomized controlled trial
    Mariana Bichuette Cartuliares, Helene Skjøt‐Arkil, Flemming Schønning Rosenvinge, Christian Backer Mogensen, Thor Aage Skovsted, Pedersen, Andreas Kristian · 2021 · Figshare
78. Additional file 2 of The Severity of Chronic Cough Diary (SCCD): development and content validation of a novel patient-reported outcome instrument for evaluating the symptom experience of chronic cough
    de la Orden Abad, Margarita, Haberland, Claudia, Hayley Karn, Anne M. Skalicky, Asha Hareendran · 2023 · Figshare
79. Additional file 1 of Impact of tobacco and/or nicotine products on health and functioning: a scoping review and findings from the preparatory phase of the development of a new self-report measure
    Esther F. Afolalu, Erica Spies, Ágnes Bacsó, Emilie Clerc, Linda Abetz‐Webb, Sophie Gallot, Chrea, Christelle · 2021 · Figshare
80. Additional file 1 of Understanding the patient experience of chronic kidney disease stages 2–3b: a qualitative interview study with Kidney Disease Quality of Life (KDQOL-36) debrief
    Anna Rydén, Nolan, Stephen, Maher, Joshua, Oren I. Meyers, Anna Kündig, Magnus K. Bjursell · 2022 · Figshare
81. Additional file 1 of A critical evaluation of the content validity of patient-reported outcome measures assessing health-related quality of life in children with cancer: a systematic review
    Rothmund, Maria, Andreas Meryk, Gerhard Rumpold, Roman Crazzolara, Samantha Claire Sodergren, Darlington, Anne-Sophie, Riedl, David · 2024 · Figshare
82. Additional file 1 of Iterative qualitative approach to establishing content validation of a patient-reported outcome measure for arm lymphedema: the LYMPH-Q Upper Extremity Module
    Manraj Nirmal Kaur, Sylvie D. Cornacchi, Elena Tsangaris, Lotte Poulsen, Louise Marie Beelen, Louise J. Bordeleau, Zhong, Toni, Mads Gustaf Jørgensen, Jens Ahm Sørensen, Babak Joseph Mehrara et al. · 2024 · Figshare
83. Additional file 3 of A critical evaluation of the content validity of patient-reported outcome measures assessing health-related quality of life in children with cancer: a systematic review
    Rothmund, Maria, Andreas Meryk, Gerhard Rumpold, Roman Crazzolara, Samantha Claire Sodergren, Darlington, Anne-Sophie, Riedl, David · 2024 · Figshare
84. Additional file 1 of Psychometric evaluation of the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) in a phase 2 clinical study
    Brad Padilla, Alan L. Shields, Taylor, Fiona, Li, Xiaoran, Mcdonald, Jeffrey, Tanya Green, Anthony L. Boral, Lin, Hui-Min, Cem Akin, Frank Siebenhaar et al. · 2021 · Figshare
85. Additional file 5 of Effectiveness of expiratory technique and induced sputum in obtaining good quality sputum from patients acutely hospitalized with suspected lower respiratory tract infection: a statistical analysis plan for a randomized controlled trial
    Mariana Bichuette Cartuliares, Helene Skjøt‐Arkil, Flemming Schønning Rosenvinge, Christian Backer Mogensen, Thor Aage Skovsted, Andreas Kristian Pedersen · 2021 · Figshare
86. Additional file 1 of Qualitative interviews to improve patient-reported outcome measures in late-onset Pompe disease: the patient perspective
    Hamed, Alaa, An Haack, Kristina, Chad J. Gwaltney, Eileen Baranowski, Andrew Stewart, Robert N. Krupnick, Tyler, Margaret, Susan E. Sparks, Paty, Jean · 2021 · Figshare
87. Additional file 1 of Developing the EPI Symptom Questionnaire (EPI-SQ): a qualitative study to understand the symptom experience of patients with exocrine pancreatic insufficiency (EPI)
    Sally Mannix, Amit R. Bodhani, Leah Kleinman, Khandelwal, Nikhil, Singh, Vikesh K. · 2024 · Figshare
88. Additional file 1 of Establishing content validity for the migraine Global Impression Item (mGI-I) assessment: a modified single-item migraine symptom severity questionnaire
    David Chandler, Marco S. Navetta, Shweta Shah, Jennifer Cline, Michael A. Phinney · 2022 · Figshare
89. Additional file 2 of Adapting the EQ-5D-3L for adults with mild to moderate learning disabilities
    John L O'Dwyer, Louise D. Bryant, Claire T. Hulme, Paul Kind, David M. Meads · 2024 · Figshare
90. Additional file 2 of A critical evaluation of the content validity of patient-reported outcome measures assessing health-related quality of life in children with cancer: a systematic review
    Rothmund, Maria, Andreas Meryk, Gerhard Rumpold, Roman Crazzolara, Samantha Claire Sodergren, Darlington, Anne-Sophie, Riedl, David · 2024 · Figshare
91. Additional file 1 of Translation, cross-cultural adaptation, and psychometric validation of the Malay version of the Assessment of Quality of Life—6 Dimensions (Malay-AQoL-6D) instrument among Malaysians living with chronic heart failure
    Yi Jing Tan, Ong, Siew Chin, Goh, Sook Pin, Chen, Gang, Yong, Vee Sim, Wei Wern Khor, Ying Min Kan, Yong Ying Choong, Ainul Mardhiyyah Zameram, Lin Yuing Tan et al. · 2024 · Figshare
92. Additional file 1 of Symptoms and impacts in anemia of chronic kidney disease
    Susan D. Mathias, Blum, Steven I., Vanja Sikirica, Johansen, Kirsten L., Hilary H. Colwell, Tony Okoro · 2020 · Figshare
93. Additional file 1 of Development and content validation of the Satisfaction and Experience Questionnaire for Granulocyte Colony-Stimulating Factor (SEQ-G-CSF)
    Aylin Yücel, Anne M. Skalicky, Olabimpe Ruth Eseyin, Yucel, Emre, Belani, Rajesh, Mark Eliot Bensink · 2021 · Figshare
94. Additional file 1 of Patient experience of spontaneous intracranial hypotension (SIH): qualitative interviews for concept elicitation
    Amrhein, Timothy J., Molly McFatrich, Kate Ehle, Michael D. Malinzak, Linda L. Gray, Peter George Kranz, Erin Hope Weant, Christina K. Zigler · 2024 · Figshare
95. Additional file 2 of Establishing content-validity of a disease-specific health-related quality of life instrument for patients with chronic hypersensitivity pneumonitis
    Kerri I. Aronson, Maha Ali, Evgeniya Reshetynak, Kaner, Robert J., Fernando J. Martínez, Monika M. Safford, Pinheiro, Laura C. · 2021 · Figshare
96. Additional file 1 of Patient experience of moderate asthma attacks: qualitative research in the USA and Germany
    Maggie M Tabberer, Jane R. Wells, Dale Chandler, Linda Abetz‐Webb, Zhang, Shiyuan, Wilhelmine Hadler Meeraus, Andy Fowler, David Slade · 2022 · Figshare
97. Additional file 1 of Patient-reported outcome measures for lupus nephritis: content validity of LupusQoL and FACIT-Fatigue
    Martin, Mona L., Hill, Jennifer N., Jennifer L Rogers, Deven Chauhan, Wen-Hung Chen, Kerry Gairy · 2024 · Figshare
98. Additional file 2 of Outcomes in patients with chronic uveitis: which factors matter to patients? A qualitative study
    Aline C. Stolk‐Vos, Hamasa Kasigar, Karlijn Jojanneke Nijmeijer, Tom Missotten, Busschbach, Jan J., Joris J. van de Klundert, Leonieke W. Kranenburg · 2020 · Figshare
99. Additional file 4 of A critical evaluation of the content validity of patient-reported outcome measures assessing health-related quality of life in children with cancer: a systematic review
    Rothmund, Maria, Andreas Meryk, Gerhard Rumpold, Roman Crazzolara, Samantha Claire Sodergren, Darlington, Anne-Sophie, Riedl, David · 2024 · Figshare
100. Additional file 5 of Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures
     Diane M. Turner‐Bowker, An Haack, Kristina, Meaghan Krohe, Andrew Yaworsky, Norma Vivas, Masami Kelly, Godhuli Chatterjee, Emily Chaston, Mann, Erin, Reaney, Matthew · 2020 · Figshare