Articles

Societal perspectives on disease and treatment attributes characterizing rare diseases: a qualitative study from the United States

Under a societal perspective, disease and treatment attributes that the general public deem important should be considered within value frameworks. The objective was to investigate how members of the general p...

Authors: Shelagh M. Szabo, Ivana F. Audhya, David Feeny, Peter Neumann, Daniel C. Malone and Katherine L. Gooch

Impact of patient-reported outcomes on symptom monitoring during treatment with checkpoint inhibitors: health-related quality of life among melanoma patients in a randomized controlled trial

In a randomized controlled trial, we previously investigated if melanoma patients receiving checkpoint inhibitors had fewer severe immune-related adverse events (irAEs) when they reported symptoms using electr...

Authors: Lærke K. Tolstrup, Helle Pappot, Lars Bastholt, Sören Möller and Karin B. Dieperink

Capturing the patient experience in systemic lupus erythematosus: Are widely used measures fit-for-purpose and adherent to FDA PRO guidance recommendations?

The 2009 Food and Drug Administration (FDA) patient-reported outcome (PRO) guidance outlines characteristics of rigorous PRO-measure development. There are a number of widely used PRO measures for Systemic Lup...

Authors: Kayleigh R. Majercak, Eleanor M. Perfetto and Ester Villalonga-Olives

Do patient-reported outcome measures measure up? A qualitative study to examine perceptions and experiences with heart failure proms among diverse, low-income patients

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a Patient-Reported Outcome Measure (PROM) used to evaluate the health status of patients with heart failure (HF) but has predominantly been tested in sett...

Authors: Jonathan Davis, Kristan Olazo, Maribel Sierra, Michelle E. Tarver, Brittany Caldwell, Anindita Saha, Sarah Lisker, Courtney Lyles and Urmimala Sarkar

The endometriosis daily diary: qualitative research to explore the patient experience of endometriosis and inform the development of a patient-reported outcome (PRO) for endometriosis-related pain

Endometriosis is a chronic disorder of the female reproductive system characterized by debilitating symptoms, particularly endometriosis-related pain (ERP). Patient-reported outcome (PRO) measures of symptoms ...

Authors: Yanfen Guan, Allison M. Nguyen, Samantha Wratten, Sharan Randhawa, Jessica Weaver, Felipe Arbelaez, Arnaud Fauconnier and Charlotte Panter

2022 Update to state of the journal of patient-reported outcomes

Authors: Ron D. Hays and Chih-Hung Chang

Patient-reported outcomes version of the common terminology criteria for adverse events and quality-of-life linear analogue self-assessment in breast cancer patients receiving radiation therapy: single-institution prospective registry

We sought to investigate the impact of patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) on overall quality-of-life (QOL) employing linear analogue self-assess...

Authors: C. S. Thorpe, T. A. DeWees, M. A. Golafshar, R. S. Bhangoo, T. Z. Vern-Gross, L. A. McGee, W. W. Wong, M. Y. Halyard, S. R. Keole and C. E. Vargas

The promise of computer adaptive testing in collection of orthopaedic outcomes: an evaluation of PROMIS utilization

A crucial component to improving patient care is better clinician understanding of patients’ health-related quality of life (HRQoL). In orthopaedic surgery, HRQoL assessment instruments such as the NIH develop...

Authors: Liam H. Wong and James E. Meeker

Adding a fatigue item to the EQ-5D-5L improves its psychometric performance in the general population

Fatigue is a common and often disturbing sequela of serious chronic health conditions. In the widely applied HRQL instrument, the EQ-5D, this aspect is not included directly, for its assumed lack of additional...

Authors: Inge Spronk, Suzanne Polinder, Gouke J. Bonsel, M. F. Janssen and Juanita A. Haagsma

Psychometric validation and meaningful change thresholds of the Worst Itching Intensity Numerical Rating Scale for assessing itch in patients with chronic kidney disease-associated pruritus

Chronic kidney disease-associated pruritus (CKD-aP) is characterized by persistent itch that often leads to substantially impaired quality of life. The Worst Itching Intensity Numerical Rating Scale (WI-NRS) i...

Authors: Margaret K. Vernon, Laura L. Swett, Rebecca M. Speck, Catherine Munera, Robert H. Spencer, Warren Wen and Frédérique Menzaghi

Examining minimal important change of the Canadian Occupational Performance Measure for subacute rehabilitation hospital inpatients

The Canadian Occupational Performance Measure (COPM) is an individualized patient-reported outcome designed to evaluate the self-perceptions of a patient’s occupational performance. Our study aimed to examine ...

Authors: Kanta Ohno, Kounosuke Tomori, Tatsunori Sawada and Ryuji Kobayashi

Combining patient reported outcomes and EHR data to understand population level treatment needs: correcting for selection bias in the migraine signature study

Electronic health records (EHR) data can be used to understand population level quality of care especially when supplemented with patient reported data. However, survey non-response can result in biased popula...

Authors: Walter F. Stewart, Xiaowei Yan, Alice Pressman, Alice Jacobson, Shruti Vaidya, Victoria Chia, Dawn C. Buse and Richard B. Lipton

Considerations for conducting and reporting digitally supported cognitive interviews with children and adults

Cognitive interviewing is a well-established qualitative method used to develop and refine PRO measures. A range of digital technologies including phone, web conferencing, and electronic survey platforms can b...

Authors: Abigail Fry, Sandra A. Mitchell and Lori Wiener

Eliciting health state utilities for Aromatic L-amino Acid Decarboxylase (AADC) deficiency: a UK vignette study

The aim of this study was to generate health state utilities for aromatic L-amino acid decarboxylase (AADC) deficiency, a rare genetic, lifelong neurogenerative condition predominantly manifesting in young inf...

Authors: Adam B. Smith, Andria Hanbury and Katharina Buesch

Development, psychometric evaluation and cognitive debriefing of the rheumatoid arthritis symptom and impact questionnaire (RASIQ)

Rheumatoid arthritis (RA) is a chronic inflammatory disease often associated with persistent pain. There is a need for a patient-reported outcome measure (PROM) that is rooted in the patient experience and psy...

Authors: Brandon Becker, Marguerite Bracher, Deven Chauhan, Regina Rendas-Baum, Xiaochen Lin, Kimberly Raymond, Meaghan O’Connor and Mark Kosinski

Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews

Though often overlooked, calming patients and increasing their life engagement are key factors in the treatment of major depressive disorder (MDD). This study aimed to test the hypothesis that adjunctive brexp...

Authors: Catherine Weiss, Stine R. Meehan, T. Michelle Brown, Catherine Gupta, Michael F. Mørup, Michael E. Thase, Roger S. McIntyre and Zahinoor Ismail

Results on patient-reported outcomes are underreported in summaries of product characteristics for new drugs

Summaries of product characteristics (SmPCs) are regulatory documents published upon drug approval. They should report all relevant study data and advise how to use drugs safely and effectively. Patient-report...

Authors: Susanne Haag, Lisa Junge, Fabian Lotz, Natalie McGauran, Marios Paulides, Regine Potthast and Thomas Kaiser

Developing a patient-driven chronic obstructive pulmonary disease (COPD) research agenda in the U.S.

To document a generalizable process for developing a patient-prioritized chronic obstructive pulmonary disease (COPD) research agenda and to provide an overview of domains that were developed in response to pe...

Authors: Inga Gruß, Gretchen M. McCreary, Ilya Ivlev, Mary Ellen Houlihan, Barbara P. Yawn, Cara Pasquale, William Clark and Richard A. Mularski

Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia

Presbyopia is a progressive condition that reduces the eye’s ability to focus on near objects with increasing age. After a systematic literature review identified no existing presbyopia-specific patient-report...

Authors: Elaheh Shirneshan, Cheryl D. Coon, Nathan Johnson, Jonathan Stokes, Ted Wells, J. Jason Lundy, David A. Andrae, Christopher J. Evans and Joanna Campbell

Characterizing the quality-of-life impact of Duchenne muscular dystrophy on caregivers: a case-control investigation

This study examined the impact of Duchenne muscular dystrophy (DMD) on family-member caregivers in terms of quality of life, life stress, and indirect costs, as compared to a stratified comparison group of par...

Authors: Carolyn E. Schwartz, Roland B. Stark, Ivana F. Audhya and Katherine L. Gooch

The sensory-reactivity PROM set: identification of a parent reported outcome measure set for autism spectrum disorder

Most children with autism spectrum disorder (ASD) suffer from aberrant responses to sensory stimuli that significantly impact the quality of life. To develop sensory interventions, individually tailored outcom...

Authors: Dorinde M. van Andel, Henk F. van Stel, Floortje E. Scheepers, Kim J. Oostrom, Lotte Haverman and Hilgo Bruining

Translation and adaptation of the EORTC QLQ-LC 29 for use in Chinese patients with lung cancer

The latest European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 29 (QLQ-LC29) has been translated and validated in several languages but not yet in simpl...

Authors: Wei Dai, Yaqin Wang, Yangjun Liu, Xing Wei, Ahmed M. Y. Osman, Cecilia Pompili, Michael Koller, Qifeng Wang, Yi Wang, Jun Ge, Tianpeng Xie and Qiang Li

Health-related quality of life for adults living with hepatitis B in the United States: a qualitative assessment

In 2019, an estimated 296 million people were living with chronic hepatitis B virus (HBV) globally with approximately 2.4 million living within the United States. Those living with HBV require years if not dec...

Authors: Catherine Freeland, Rhea Racho, Maureen Kamischke, Kate Moraras, Evangeline Wang, Chari Cohen and Stuart Kendrick

Cancer follow-up supported by patient-reported outcomes in patients undergoing intended curative complex surgery for advanced cancer

Patient activation (PA) and Patient Involvement (PI) are considered elements in good survivorship. We aimed to evaluate the effect of a follow-up supported by electronic patient-reported outcomes (ePRO) on PA ...

Authors: Sissel Ravn, Henriette Vind Thaysen, Victor Jilbert Verwaal, Lene Seibæk and Lene Hjerrild Iversen

Structural validity of the Arabic version of the disabilities of the Arm, Shoulder and Hand (DASH) using Rasch measurement model

The disabilities of the arm, shoulder and hand (DASH) is a commonly used region-specific patient-reported outcome measure (PROM) that quantify upper extremity function (activity limitation) and symptoms. Curre...

Authors: Ali H. Alnahdi

Development and equivalence of new faces for inclusion in the Childhood Asthma Control Test (C-ACT) response scale

Accurate symptom monitoring is vital when managing pediatric asthma, providing an opportunity to improve control and relieve associated burden. The CHILDHOOD ASTHMA CONTROL TEST (C-ACT) has been validated for ...

Authors: Kate Sully, Nicola Bonner, Helena Bradley, Robyn von Maltzahn, Rob Arbuckle, Louise Walker-Nthenda, Aoife Mahon, Brandon Becker, Louise O’Hara, Katherine B. Bevans, Mark Kosinski, Robert S. Zeiger, Ross Mackenzie and Linda Nelsen

Development of a conceptual model for research on cyclical variation of patient reported outcome measurements (PROMs) in patients with chronic conditions: a scoping review

Although circadian, seasonal, and other cycles have been observed for a number of chronic conditions, their impact on patient reported outcomes measurements (PROMs) has not been systematically explored, render...

Authors: A. F. Davey, J. Coombes, I. Porter, C. Green, A. J. Mewse and J. M. Valderas

Personalized outcomes for hip and knee replacement: the patients point of view

Patient reported outcome measures (PROMs) are increasingly being incorporated into clinical and surgical care for assessing outcomes. This study examined outcomes important to patients in their decision to hav...

Authors: Robin R. Whitebird, Leif I. Solberg, Jeanette Y. Ziegenfuss, Stephen E. Asche, Christine K. Norton, Marc F. Swiontkowski, Steven P. Dehmer and Elizabeth S. Grossman

Correction to: Patient-reported outcome measures in the care of in-centre hemodialysis patients

Authors: Sara N. Davison, Scott Klarenbach, Braden Manns, Kara Schick-Makaroff, Robert Buzinski, Bonnie Corradetti, Hilary Short and Jefrey A. Johnson

Understanding the visual function symptoms and associated functional impacts of phakic presbyopia

Presbyopia is defined as the age-related deterioration in the ability to focus on close objects, causing difficulty with near vision tasks. The study aim was to understand the lived experience of phakic presby...

Authors: Sarah Bentley, Amy Findley, Sima Chiva-Razavi, Christel Naujoks, Francesco Patalano, Chloe Johnson, Rob Arbuckle and James S. Wolffsohn

Translation and cultural validation of the University of Washington Caregiver Stress and Benefit Scales

English versions of the University of Washington Caregiver Stress (UW-CSS) and Benefit (UW-CBS) Scales were developed in the United States (US) to measure impact on caregivers of caring for a child/children. C...

Authors: Dagmar Amtmann, Alyssa M. Bamer, Rana Salem, Arnold R. Gammaitoni, Bradley S. Galer and Mark P. Jensen

Hepatic schistosomiasis, upper gastrointestinal bleeding, and health related quality of life measurements from the Albert Nile Basin

Health related quality of life measurements are vital elements of public health surveillance that uncover unmet health needs and predict the success of health interventions. We described health related quality...

Authors: Christopher K. Opio, Francis Kazibwe, Lalitha Rejani, Narcis B. Kabatereine and Ponsiano Ocama

Burden of mental health symptoms and perceptions of their management in in-centre hemodialysis care: a mixed methods study

We aimed to describe (1) depressive and anxiety symptom burdens reported by adults on in-centre hemodialysis in Northern Alberta, Canada and (2) patients’ and nurses’ perceptions of managing such symptoms usin...

Authors: Kara Schick-Makaroff, Lisa A. Wozniak, Hilary Short, Sara N. Davison, Scott Klarenbach, Robert Buzinski, Michael Walsh and Jeffrey A. Johnson

The burden of pharmacological treatment on health-related quality of life in people with a urea cycle disorder: a qualitative study

Urea cycle disorders (UCD) are inborn errors of metabolism, typically presenting neonatally. Excess ammonia builds rapidly within the body risking hyperammonemic episodes and potentially death. Long-term manag...

Authors: Gillian Yeowell, Danielle Stephanie Burns and Francis Fatoye

Evaluation of the content validity of patient-reported outcome (PRO) instruments developed for use with individuals with phakic presbyopia, including the Near Activity Visual Questionnaire-presbyopia (NAVQ-P) and the near vision correction independence (NVCI) instrument

Presbyopia is the age-related deterioration in the ability to focus on close objects. In order to develop a patient-reported outcome (PRO) instrument to assess near vision functioning, the Near Activity Visual...

Authors: Sarah Bentley, Amy Findley, Sima Chiva-Razavi, Christel Naujoks, Francesco Patalano, Chloe Johnson, Rob Arbuckle and James S. Wolffsohn

Psychometric properties of the Persian version of the quality of recovery-15 questionnaire

Recovery after surgery is a complex process since it depends on many factors, such as the patient’s sex, age, surgery type, and presence of other diseases. This study aimed to translate and evaluate the psycho...

Authors: Hooman Shahsavari, Golnar Ghane, Shahrzad Ghiyasvandian, Masoumeh Zakerimoghadam and Fatemeh Najafi

Patient-reported outcome measures for clinical decision-making in outpatient follow-up: validity and reliability of a renal disease questionnaire

Patient-reported outcome measures are increasingly used by clinicians to support communication in telephone- or face-to-face consultations with patients. A renal disease questionnaire has been developed, but n...

Authors: Birgith Engelst Grove, Liv Marit Valen Schougaard, Per Ramløv Ivarsen, Derek Kyte, Niels Henrik Hjollund and Annette de Thurah

Preferences on how to measure and discuss health related quality of life within integrated care for children with obesity

Childhood obesity can affect physical as well as psychosocial wellbeing. Therefore, childhood obesity care aims to improve all dimensions of health related quality of life (HRQoL). HRQoL can be measured with t...

Authors: Minke M. A. Eilander, Marieke M. A. van Mil, Leandra W. Koetsier, Jacob C. Seidell and Jutka Halberstadt

Psychometrics of three Swedish physical pediatric item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS)®: pain interference, fatigue, and physical activity

The Patient-Reported Outcomes Measurement Information System (PROMIS®) aims to provide self-reported item banks for several dimensions of physical, mental and social health. Here we investigate the psychometri...

Authors: Frida Carlberg Rindestig, Marie Wiberg, John Eric Chaplin, Eva Henje and Inga Dennhag

Implementation of EQ-5D-5L as a routine outcome measure in Community Outpatient and Specialized Rehabilitation Services

Rehabilitation is a person-centred approach that optimizes functioning to reduce impairments in individuals with illness, injury or disability. Patient-reported outcome measures (PROMs) have a role in rehabili...

Authors: Katie Churchill, Lisa Warner, Eileen Keogh and Fatima Al Sayah

Selection of patient-reported outcome measures (PROMs) for use in health systems

Many healthcare systems around the world have been increasingly using patient-reported outcome measures (PROMs) in routine outcome measurement to enhance patient-centered care and incorporate the patient’s per...

Authors: Fatima Al Sayah, Xuejing Jin and Jeffrey A. Johnson

A multi-level approach for the use of routinely collected patient-reported outcome measures (PROMs) data in healthcare systems

Authors: Fatima Al Sayah, Markus Lahtinen, Gouke J. Bonsel, Arto Ohinmaa and Jeffrey A. Johnson

Utilizing Patient Reported Outcome Measures (PROMs) in ambulatory oncology in Alberta: Digital reporting at the micro, meso and macro level

Cancer patients experience numerous distressing symptoms and concerns across the course of their illness, which negatively influence their quality of life. Regardless of cancer type, unmanaged symptoms can lea...

Authors: Linda Watson, Andrea Delure, Siwei Qi, Claire Link, Lindsi Chmielewski, Éclair Photitai and Louise Smith

Advancing PROMs for health system use in Canada and beyond

PROMs are essential to delivering patient-centred health care, and when applied routinely they can enhance communication between patients and providers, inform decisions for value-based health system improveme...

Authors: Michael Terner, Krista Louie, Candy Chow and Greg Webster

Patient-reported outcome measures in the care of in-centre hemodialysis patients

Kidney failure requiring dialysis is associated with high symptom burden and low health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) are standardized instruments that capture patie...

Authors: Sara N. Davison, Scott Klarenbach, Braden Manns, Kara Schnick-Makaroff, Robert Buzinski, Bonnie Corradetti, Hilary Short and Jeffrey A. Johnson

Measuring value in healthcare from a patients’ perspective

Authors: Stafford Dean, Fatima Al Sayah and Jeffrey A. Johnson

The use of patient-reported outcome measures in hip and knee arthroplasty in Alberta

PROMs are part of routine measurement for hip and knee replacement in Alberta, Canada. We provide an overview of how PROMs are implemented in routine care, and how we use PROMs data for decision-making at diff...

Authors: Deborah A. Marshall, Xuejing Jin, Lindsay B. Pittman and Christopher J. Smith

The use of patient-reported outcome measures in primary care: applications, benefits and challenges

PROMs use in primary care has expanded from simply describing patient populations to contributing to decision-making, in response to the increasingly complex, ever-changing healthcare environment. In Alberta, ...

Authors: Krista Brower, Margo Schmitt-Boshnick, Michel Haener, Shea Wilks and Allison Soprovich

The use of patient-reported measures in epilepsy care: the Calgary Comprehensive Epilepsy Program experience

The regular use of patient-reported measures (PRMs) has been associated with greater patient satisfaction and outcomes. In this article, we will review the Calgary Comprehensive Epilepsy Program's successful e...

Authors: Guillermo Delgado-García, Samuel Wiebe and Colin B. Josephson

Measuring respiratory symptoms in moderate/severe asthma: evaluation of a respiratory symptom tool, the E-RS®: COPD in asthma populations

Symptom constructs included in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS®: COPD) tool may be relevant to patients with asthma. The purpose of this study was to evaluate...

Authors: Maggie Tabberer, Robyn von Maltzahn, Elizabeth D. Bacci, Hayley Karn, Ray Hsieh, Timothy A. Howell, Zelie Bailes, Andrew Fowler, Laurie Lee and Lindsey T. Murray