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Development and Psychometric Evaluation of the FACE-Q Scales for Patients Undergoing Rhinoplasty

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Estimating Health-State Utility for Economic Models in Clinical Studies: An ISPOR Good Research Practices Task Force Report

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AmbuFlex: tele-patient-reported outcomes (telePRO) as the basis for follow-up in chronic and malignant diseases

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International phase I study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q)

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A systematic review highlights the need to investigate the content validity of patient-reported outcome measures for physical functioning in patients with low back pain

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SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

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New Trial Designs and Potential Therapies for Pulmonary Artery Hypertension

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What Aspects of Quality of Life Are Important From Palliative Care Patients' Perspectives? A Systematic Review of Qualitative Research

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Patient-reported Symptoms of Tenosynovial Giant Cell Tumors

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Development and Psychometric Validation of the FACE-Q Skin, Lips, and Facial Rhytids Appearance Scales and Adverse Effects Checklists for Cosmetic Procedures

Klassen, A. F., Cano, S., Schwitzer, J. A., Baker, S. B., CARRUTHERS, A. J., Carruthers, J., Chapas, A. M., & Pusic, A. L. (2016) · JAMA Dermatology · doi:10.1001/jamadermatol.2016.0018 · Cited by 107 · see citing works

Checklist to operationalize measurement characteristics of patient-reported outcome measures

Francis, D. O., McPheeters, M. L., Noud, M., Penson, D. F., & Feurer, I. D. (2016) · Systematic Reviews · doi:10.1186/s13643-016-0307-4 · Cited by 107 · see citing works

“‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata

Aldhouse, N. V. J., Kitchen, H., Knight, S. L., Macey, J., Nunes, F. P., Dutronc, Y., Mesinkovska, N. A., Ko, J., King, B., & Wyrwich, K. W. (2020) · Journal of Patient-Reported Outcomes · doi:10.1186/s41687-020-00240-7 · Cited by 105 · see citing works

The impact of hyperhidrosis on patients' daily life and quality of life: a qualitative investigation

Kamudoni, P., Mueller, B., Halford, J. C. G., Schouveller, A., Stacey, B., & Salek, S. (2017) · Health and Quality of Life Outcomes · doi:10.1186/s12955-017-0693-x · Cited by 103 · see citing works

What Matters to Patients With Cleft Lip and/or Palate

Riff, K. W. Y. W., Tsangaris, E., Goodacre, T., Forrest, C. R., Lawson, J. L., Pusic, A. L., & Klassen, A. F. (2017) · The Cleft Palate-Craniofacial Journal · doi:10.1177/1055665617732854 · Cited by 100 · see citing works

“Sometimes It’s Difficult to Have a Normal Life”: Results from a Qualitative Study Exploring Caregiver Burden in Schizophrenia

Gater, A., Rofail, D., Tolley, C., Marshall, C., Abetz‐Webb, L., Zarit, S. H., & Berardo, C. G. (2014) · Schizophrenia Research and Treatment · doi:10.1155/2014/368215 · Cited by 102 · see citing works

Development of a New Patient-reported Outcome Instrument to Evaluate Treatments for Scars: The SCAR-Q

Klassen, A. F., Ziolkowski, N. I., Mundy, L. R., Miller, H. C., McIlvride, A., DiLaura, A., Fish, J. S., & Pusic, A. L. (2018) · Plastic & Reconstructive Surgery Global Open · doi:10.1097/gox.0000000000001672 · Cited by 96 · see citing works

Clinical outcome assessment in clinical trials of chronic pain treatments

Patel, K. V., Amtmann, D., Jensen, M. P., Smith, S. M., Veasley, C., & Turk, D. C. (2021) · PAIN Reports · doi:10.1097/pr9.0000000000000784 · Cited by 96 · see citing works

Patient Reported Outcomes in Rheumatoid Arthritis Clinical Trials

Orbai, A., & Bingham, C. O. (2015) · Current Rheumatology Reports · doi:10.1007/s11926-015-0501-8 · Cited by 95 · see citing works

Patient-reported outcomes in meta-analyses – Part 1: assessing risk of bias and combining outcomes

Johnston, B. C., Patrick, D. L., Busse, J. W., Schünemann, H. J., Agarwal, A., & Guyatt, G. H. (2013) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-11-109 · Cited by 95 · see citing works

Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on ‘Feels, Functions, Survives’. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency

Raghu, G., Ghazipura, M., Fleming, T. R., Aronson, K. I., Behr, J., Brown, K. M., Flaherty, K. R., Kazerooni, E. A., Maher, T. M., Richeldi, L., et al. (2024) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.202312-2213so · Cited by 98 · see citing works

Advancing Clinical Trials for Inherited Retinal Diseases: Recommendations from the Second Monaciano Symposium

Thompson, D. A., Iannaccone, A., Ali, R. R., Arshavsky, V. Y., Audo, I. S., Bainbridge, J. W., Besirli, C. G., Birch, D. G., Branham, K. E. H., Cideciyan, A. V., et al. (2020) · Translational Vision Science & Technology · doi:10.1167/tvst.9.7.2 · Cited by 94 · see citing works

FACE-Q Skin Cancer Module for measuring patient-reported outcomes following facial skin cancer surgery

Lee, E. H., Klassen, A. F., Cano, S., Nehal, K. S., & Pusic, A. L. (2018) · British Journal of Dermatology · doi:10.1111/bjd.16671 · Cited by 94 · see citing works

Measuring the impact of migraine for evaluating outcomes of preventive treatments for migraine headaches

Mannix, S., Skalicky, A. M., Buse, D. C., Desai, P., Sapra, S. J., Ortmeier, B. G., Widnell, K. L., & Hareendran, A. (2016) · Health and Quality of Life Outcomes · doi:10.1186/s12955-016-0542-3 · Cited by 89 · see citing works

Patient involvement in the development of patient-reported outcome measures: The developers’ perspective

Wiering, B., de Boer, D., & Delnoij, D. M. J. (2017) · BMC Health Services Research · doi:10.1186/s12913-017-2582-8 · Cited by 89 · see citing works

Development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0: a qualitative study

Carrière, M. E., Mokkink, L. B., Tyack, Z. F., Westerman, M. J., Pijpe, A., Pleat, J., van de Kar, A. L., Brown, J. N., de Vet, H. C. W., & van Zuijlen, P. P. M. (2022) · Quality of Life Research · doi:10.1007/s11136-022-03244-6 · Cited by 91 · see citing works

What is important for you? A qualitative interview study of living with diabetes and experiences of diabetes care to establish a basis for a tailored Patient-Reported Outcome Measure for the Swedish National Diabetes Register

Engström, M. S., Leksell, J. K., Johansson, U., & Guðbjörnsdóttir, S. (2016) · BMJ Open · doi:10.1136/bmjopen-2015-010249 · Cited by 87 · see citing works

Establishing Content Validity of the CLEFT-Q: A New Patient-reported Outcome Instrument for Cleft Lip/Palate

Tsangaris, E., Riff, K. W. Y. W., Goodacre, T., Forrest, C. R., Dreise, M. M., Sykes, J. M., de Chalain, T., Harman, K., O'Mahony, A. M., Pusic, A. L., et al. (2017) · Plastic & Reconstructive Surgery Global Open · doi:10.1097/gox.0000000000001305 · Cited by 87 · see citing works

Tutorial on how to calculating content validity of scales in medical research

Madadizadeh, F., & Bahariniya, S. (2023) · Perioperative Care and Operating Room Management · doi:10.1016/j.pcorm.2023.100315 · Cited by 97 · see citing works

Value to Whom? The Patient Voice in the Value Discussion

Perfetto, E. M., Oehrlein, E. M., Boutin, M., Reid, S. M., & Gascho, E. (2017) · Value in Health · doi:10.1016/j.jval.2016.11.014 · Cited by 83 · see citing works

An overview of using qualitative techniques to explore and define estimates of clinically important change on clinical outcome assessments

Staunton, H., Willgoss, T., Nelsen, L. M., Burbridge, C., Sully, K., Rofail, D., & Arbuckle, R. (2019) · Journal of Patient-Reported Outcomes · doi:10.1186/s41687-019-0100-y · Cited by 81 · see citing works

Development of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT®) questionnaire: a new patient-reported outcome instrument for PAH

McCollister, D. H., Shaffer, S., Badesch, D. B., Filusch, A., Hunsche, E., Schüler, R., Wiklund, I. E., & Peacock, A. J. (2016) · Respiratory Research · doi:10.1186/s12931-016-0388-6 · Cited by 80 · see citing works

A call to action to inform patient‐centred approaches to obesity management: Development of a disease‐illness model

Fastenau, J. M., Kolotkin, R. L., Fujioka, K., Alba, M., Canovatchel, W. J., & Traina, S. (2019) · Clinical Obesity · doi:10.1111/cob.12309 · Cited by 78 · see citing works

Qualitative validation of the FACIT-Fatigue scale in systemic lupus erythematosus

Kosinski, M. R., Gajria, K., Fernandes, A., & Cella, D. F. (2013) · Lupus · doi:10.1177/0961203313476360 · Cited by 79 · see citing works

Measurement challenges in shared decision making: putting the ‘patient’ in patient‐reported measures

Barr, P. J., & Elwyn, G. J. (2015) · Health Expectations · doi:10.1111/hex.12380 · Cited by 78 · see citing works

Evidence-Based Interventions for Adult Aural Rehabilitation: That Was Then, This Is Now

Maidment, D. W., Henshaw, H., Heffernan, E., & Ferguson, M. (2019) · Seminars in Hearing · doi:10.1055/s-0038-1676784 · Cited by 76 · see citing works

Patient-Reported Outcome Instruments for Physical Symptoms Among Patients Receiving Maintenance Dialysis: A Systematic Review

Flythe, J. E., Powell, J. D., Poulton, C. J., Westreich, K. D., Handler, L., Reeve, B. B., & Carey, T. S. (2015) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2015.05.020 · Cited by 75 · see citing works

Measuring respiratory symptoms in clinical trials of COPD: reliability and validity of a daily diary

Leidy, N. K., Sexton, C., Jones, P., Notte, S. M., Monz, B. U., Nelsen, L. M., Goldman, M. H., Murray, L. T., & Sethi, S. (2014) · Thorax · doi:10.1136/thoraxjnl-2013-204428 · Cited by 73 · see citing works

International guidance on the selection of patient-reported outcome measures in clinical trials: a review

Crossnohere, N. L., Brundage, M., Calvert, M., King, M. T., Reeve, B. B., Thorner, E. D., Wu, A. W., & Snyder, C. F. (2020) · Quality of Life Research · doi:10.1007/s11136-020-02625-z · Cited by 77 · see citing works

FACE-Q Eye Module for Measuring Patient-Reported Outcomes Following Cosmetic Eye Treatments

Klassen, A. F., Cano, S., Grotting, J. C., Baker, S. B., Carruthers, J., CARRUTHERS, A. J., Laeken, N. V., Sykes, J. M., Schwitzer, J. A., & Pusic, A. L. (2016) · JAMA Facial Plastic Surgery · doi:10.1001/jamafacial.2016.1018 · Cited by 70 · see citing works

The PROactive innovative conceptual framework on physical activity

Dobbels, F., de Jong, C., Drost, E., Elberse, J., Feridou, C., Jacobs, L., Rabinovich, R., Frei, A., Puhan, M. A., de Boer, W. I., et al. (2014) · European Respiratory Journal · doi:10.1183/09031936.00004814 · Cited by 67 · see citing works

A specific method for qualitative medical research: the IPSE (Inductive Process to analyze the Structure of lived Experience) approach

Sibéoni, J., Verneuil, L., Manolios, É., & Révah‐Levy, A. (2020) · BMC Medical Research Methodology · doi:10.1186/s12874-020-01099-4 · Cited by 70 · see citing works

Patient-Reported Outcome Measures in Lymphedema: A Systematic Review and COSMIN Analysis

Beelen, L. M., van Dishoeck, A., Tsangaris, E., Coriddi, M. R., Dayan, J. H., Pusic, A. L., Klassen, A. F., & Vasilic, D. (2020) · Annals of Surgical Oncology · doi:10.1245/s10434-020-09346-0 · Cited by 72 · see citing works

Tools for assessing the scalability of innovations in health: a systematic review

Charif, A. B., Zomahoun, H. T. V., Gogovor, A., Samri, M. A., Massougbodji, J., Wolfenden, L., Ploeg, J., Zwarenstein, M., Milat, A., Rhéault, N., et al. (2022) · Health Research Policy and Systems · doi:10.1186/s12961-022-00830-5 · Cited by 71 · see citing works

A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathy

Karaa, A., Haas, R., Goldstein, A. C., Vockley, J. E., & Cohen, B. H. (2020) · Journal of Cachexia Sarcopenia and Muscle · doi:10.1002/jcsm.12559 · Cited by 68 · see citing works

Content validity: judging the relevance, comprehensiveness, and comprehensibility of an outcome measurement instrument – a COSMIN perspective

Mokkink, L. B., Herbelet, S., Tuinman, P. R., & Terwee, C. B. (2025) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2025.111879 · Cited by 96 · see citing works

Characterizing mobility from the prosthetic limb user’s perspective

Hafner, B. J., Morgan, S. J., Abrahamson, D. C., & Amtmann, D. (2015) · Prosthetics and Orthotics International · doi:10.1177/0309364615579315 · Cited by 66 · see citing works

Patients’ appropriateness, acceptability, usability and preferences for pharmaceutical preparations: Results from a literature review on clinical evidence

Drumond, N., van Riet‐Nales, D. A., Karapinar‐Çarkit, F., & Stegemann, S. (2017) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2017.02.029 · Cited by 66 · see citing works

Patients’ Perspectives on Outcomes of Care After Discharge From the Emergency Department: A Qualitative Study

Vaillancourt, S., Seaton, M. B., Schull, M. J., Cheng, A. H. Y., Beaton, D., Laupacis, A., & Dainty, K. N. (2017) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2017.05.034 · Cited by 65 · see citing works

Development of the BODY-Q Chest Module Evaluating Outcomes following Chest Contouring Surgery

Klassen, A. F., Kaur, M. N., Poulsen, L., Fielding, C., Geerards, D., van de Grift, T. C., Hoogbergen, M. M., Juhl, C. B., Lorenzen, M. M., McEvenue, G., et al. (2018) · Plastic & Reconstructive Surgery · doi:10.1097/prs.0000000000004978 · Cited by 66 · see citing works

Understanding the Symptom Burden and Impact of Myasthenia Gravis from the Patient’s Perspective: A Qualitative Study

Jackson, K., Parthan, A., Lauher-Charest, M., Broderick, L. E., Law, N., & Barnett, C. (2022) · Neurology and Therapy · doi:10.1007/s40120-022-00408-x · Cited by 64 · see citing works

The Use of Qualitative Methods in Developing the Descriptive Systems of Preference-Based Measures of Health-Related Quality of Life for Use in Economic Evaluation

Stevens, K. J., & Palfreyman, S. J. (2012) · Value in Health · doi:10.1016/j.jval.2012.08.2204 · Cited by 64 · see citing works

Nurse perceptions of organizational culture and its association with the culture of error reporting: a case of public sector hospitals in Pakistan

Jafree, S. R., Zakar, R., Zakar, M. Z., & Fischer, F. (2015) · BMC Health Services Research · doi:10.1186/s12913-015-1252-y · Cited by 62 · see citing works

Patient-Reported Outcome Measures

Poulsen, L., McEvenue, G., Klassen, A. F., Hoogbergen, M. M., Sørensen, J. A., & Pusic, A. L. (2018) · Clinics in Plastic Surgery · doi:10.1016/j.cps.2018.08.003 · Cited by 61 · see citing works

Patient Reported Outcome Measures (PROMs) in Inflammatory Bowel Disease: New Data

Bojic, D., Bodger, K., & Travis, S. P. L. (2016) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjw187 · Cited by 60 · see citing works

Patient-reported outcome measures for acute and chronic pain

Pogatzki-Zahn, E. M., Schnabel, K., & Kaiser, U. (2019) · Current Opinion in Anaesthesiology · doi:10.1097/aco.0000000000000780 · Cited by 59 · see citing works

A Systematic Review of Patient-Reported Outcome Measures Used in Adult Burn Research

Griffiths, C., Guest, E., White, P., Gaskin, E., Rumsey, N., Pleat, J., & Harcourt, D. M. (2016) · Journal of Burn Care & Research · doi:10.1097/bcr.0000000000000474 · Cited by 60 · see citing works

Patient-reported fatigue and its impact on patients with systemic lupus erythematosus

Sterling, K., Gallop, K., Swinburn, P., Flood, E. M., French, A., Sawah, S. A., Iikuni, N., Naegeli, A. N., & Nixon, A. (2013) · Lupus · doi:10.1177/0961203313511554 · Cited by 58 · see citing works

A Qualitative Research for Defining Meaningful Attributes for the Treatment of Inflammatory Bowel Disease from the Patient Perspective

Louis, E. J., Ramos-Goñi, J. M., Cuervo, J., Kopylov, U., Acosta, M. B., McCartney, S. A., Rosenfeld, G. A., Bettenworth, D., Hart, A., Novak, K. L., et al. (2020) · Patient · doi:10.1007/s40271-019-00407-5 · Cited by 58 · see citing works

Qualitative Methods and Patient-Reported Outcomes

Cheng, K. K. F., & Clark, A. M. (2017) · International Journal of Qualitative Methods · doi:10.1177/1609406917702983 · Cited by 57 · see citing works

Performance of the EXAcerbations of Chronic Pulmonary Disease Tool Patient-reported Outcome Measure in Three Clinical Trials of Chronic Obstructive Pulmonary Disease

Leidy, N. K., Murray, L. T., Jones, P., & Sethi, S. (2014) · Annals of the American Thoracic Society · doi:10.1513/annalsats.201309-305oc · Cited by 57 · see citing works

Assessing Outcomes in Body Contouring

Klassen, A. F., Cano, S., Scott, A., Tsangaris, E., & Pusic, A. L. (2014) · Clinics in Plastic Surgery · doi:10.1016/j.cps.2014.06.004 · Cited by 57 · see citing works

Validation and reliability of a disease‐specific quality of life measure (the T ran Q ol) in adults and children with thalassaemia major

Klaassen, R. J., Barrowman, N. J., Merelles‐Pulcini, M., Vichinsky, E. P., Sweeters, N., Kirby-Allen, M. A., Neufeld, E. J., Kwiatkowski, J. L., Wu, J. K., Vickars, L. M., et al. (2013) · British Journal of Haematology · doi:10.1111/bjh.12631 · Cited by 56 · see citing works

Development and validation of the Cholinergic Urticaria Quality‐of‐Life Questionnaire (CholU‐QoL)

Ruft, J., Asady, A., Staubach, P., Casale, T. B., Sussmann, G., Zuberbier, T., Maurer, M., Weller, K., & Altrichter, S. (2018) · Clinical and Experimental Allergy · doi:10.1111/cea.13102 · Cited by 45 · see citing works

Prospective development of a patient‐reported outcomes instrument for desmoid tumors or aggressive fibromatosis

Gounder, M. M., Maddux, L., Paty, J. A., & Atkinson, T. M. (2019) · Cancer · doi:10.1002/cncr.32555 · Cited by 56 · see citing works

Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis

Dulai, P. S., Jairath, V., Khanna, R., Ma, C., McCarrier, K. P., Martin, M. L., Parker, C. E., Morris, J. C., Feagan, B. G., & Sandborn, W. J. (2020) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.15726 · Cited by 56 · see citing works

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 2—Assessing Respondent Understanding

Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L. (2011) · Value in Health · doi:10.1016/j.jval.2011.06.013 · Cited by 1,135 · see citing works

Use of Existing Patient-Reported Outcome (PRO) Instruments and Their Modification: The ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report

Rothman, M. L., Burke, L. B., Erickson, P., Leidy, N. K., Patrick, D. L., & Petrie, C. D. (2009) · Value in Health · doi:10.1111/j.1524-4733.2009.00603.x · Cited by 433 · see citing works

Use of Existing Patient-Reported Outcome (PRO) Instruments andTheir Modification:The ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments andTheir Modification PROTask

Patrick, D. L., & Petrie, C. D. (2015)

Establishing Optimal Requirements for Content Validity: A Work in Progress

Fehnel, S. E. (2009) · Value in Health · doi:10.1111/j.1524-4733.2009.00654.x · Cited by 1 · see citing works

Perspectives on Patient-Reported Outcomes

Leidy, N. K., & Vernon, M. (2008) · PharmacoEconomics · doi:10.2165/00019053-200826050-00002 · Cited by 206 · see citing works