Articles

The validity and reliability of the patient enablement instrument (PEI) after GP appointments in Finnish health care centres

The aim of this study was to assess the validity and reliability of the Patient Enablement Instrument (PEI) in Finnish health care centre patients. A pilot study was conducted to assess the content validity of...

Authors: Elina Tolvanen, Tuomas H. Koskela, Mika Helminen and Elise Kosunen

Collection and use of EQ-5D for follow-up, decision-making, and quality improvement in health care - the case of the Swedish National Quality Registries

The Swedish National Quality Registries (NQRs) contain individual-level health care data for specific patient populations, or patients receiving specific interventions. Approximately 90% of the 105 Swedish NQR...

Authors: Olivia Ernstsson, Mathieu F. Janssen and Emelie Heintz

Core outcome sets in cancer and their approaches to identifying and selecting patient-reported outcome measures: a systematic review

Issues arising from a lack of outcome standardisation in health research may be addressed by the use of core outcome sets (COS), which represent agreed-upon recommendations regarding what outcomes should be me...

Authors: Imogen Ramsey, Marion Eckert, Amanda D. Hutchinson, Julie Marker and Nadia Corsini

“‘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

Alopecia areata (AA) is characterized by hair loss that can affect the scalp and body. This study describes the psychosocial burden of AA.

Authors: Natalie V. J. Aldhouse, Helen Kitchen, Sarah Knight, Jake Macey, Fabio P. Nunes, Yves Dutronc, Natasha Mesinkovska, Justin M. Ko, Brett A. King and Kathleen W. Wyrwich

Qualitative research to explore the symptoms and impacts experienced by children with ulcerative colitis

Ulcerative Colitis (UC) is a chronic gastrointestinal disease that often presents during one’s most productive years and is characterized by colon inflammation. Key symptoms and impacts in adults are well-know...

Authors: Jason A. Randall, Aiste Guobyte, Laure Delbecque, Louise Newton, Tara Symonds and Theresa Hunter

Using a digital patient powered research network to identify outcomes of importance to patients with multiple myeloma

Social media platforms give patients a voice by allowing them to discuss their health and connect with others. These unfiltered and genuine reports offer direct access to what matters most to patients. Explori...

Authors: Katharine S. Gries and John Fastenau

Changes in the ability to participate in and satisfaction with social roles and activities in patients in outpatient rehabilitation

One of the main aims of rehabilitation is to improve participation. Patient-Reported Outcomes Measurement Information System (PROMIS®) item banks ‘Ability to Participate in Social roles and Activities, (PROMIS...

Authors: Sietske J. Tamminga, Félicie M. van Vree, Gerard Volker, Leo D. Roorda, Caroline B. Terwee, Paulien H. Goossens and Thea P. M. Vliet Vlieland

Exploring the influence of socio-cultural factors and environmental resources on the health related quality of life of children and adolescents after congenital heart disease surgery: parental perspectives from a low middle income country

Health related quality of life (HRQOL) is an important indicator of long-term well-being, influenced by environmental factors such as family, culture, societal norms and available resources. This study aimed t...

Authors: Laila A. Ladak, Robyn Gallagher, Babar S. Hasan, Khadija Awais, Ahmed Abdullah and Janice Gullick

Delphi survey to inform patient-reported symptom monitoring after ovarian cancer treatment

Increasing numbers of ovarian cancer patients are living longer and requiring regular follow-up to detect disease recurrence. New models of follow-up care are needed to meet the growing number and needs of thi...

Authors: Leanne Shearsmith, Fiona Kennedy, Oana C. Lindner and Galina Velikova

Measuring the impact of chronic low back pain on everyday functioning: content validity of the Roland Morris disability questionnaire

Robust outcome measures are needed to assess and monitor the impact of chronic low back pain (CLBP) on physical functioning. The Roland Morris Disability Questionnaire (RMDQ) is a well-established measure desi...

Authors: Claire Burbridge, Jason A. Randall, Lucy Abraham and Elizabeth Nicole Bush

Content validity of patient-reported outcomes for use in lower-risk myelodysplastic syndromes

The lower-risk (low and intermediate-1 risk based on IPSS) myelodysplastic syndrome (MDS) has a negative impact on patients’ health-related quality of life (HRQoL). Patient Reported Outcomes (PROs) instruments...

Authors: Jeremiah J. Trudeau, Jianming He, Esther Rose, Charlotte Panter, Sharan Randhawa and Adam Gater

What is an estimand & how does it relate to quantifying the effect of treatment on patient-reported quality of life outcomes in clinical trials?

Published in 2019, a new addendum to the ICH E9 guideline presents the estimand framework as a systematic approach to ensure alignment among clinical trial objectives, trial execution/conduct, statistical anal...

Authors: Rachael Lawrance, Evgeny Degtyarev, Philip Griffiths, Peter Trask, Helen Lau, Denise D’Alessio, Ingolf Griebsch, Gudrun Wallenstein, Kim Cocks and Kaspar Rufibach

Psychometric validation of a Saudi Arabian version of the sf-36v2 health survey and norm data for Saudi Arabia

Adaptation of a patient-reported outcomes survey into a new language requires careful translation procedures as well as qualitative and quantitative psychometric testing. This study aimed to evaluate the basic...

Authors: Ahmad AboAbat, Hazem Qannam, Jakob Bue Bjorner and Mohamad Al-Tannir

Patient-reported outcome measures for retinoblastoma: a scoping review

Retinoblastoma is a childhood retinal cancer with lifelong consequences such as vision loss and increased risk of second cancer. Patient-reported outcome measures (PROMs) are instruments that measure outcomes ...

Authors: Ana Janic, Sylvie Bowden, Sarah Levy, Jennifer Stinson and Helen Dimaras

Patients’ experiences of Parkinson’s disease: a qualitative study in glucocerebrosidase and idiopathic Parkinson’s disease

Approximately 7–10% of Parkinson’s disease (PD) patients carry a GBA (Glucocerebrosidase) mutation (GBA-PD patients), which may influence the disease’s clinical course.

Authors: N. Bonner, S. Bozzi, L. Morgan, B. Mason, M. J. Peterschmitt, T. Z. Fischer, R. Arbuckle and M. Reaney

Symptoms and impacts in anemia of chronic kidney disease

Anemia is a frequent complication of chronic kidney disease (CKD) that negatively affects patients’ health-related quality of life.

Authors: Susan D. Mathias, Steven I. Blum, Vanja Sikirica, Kirsten L. Johansen, Hilary H. Colwell and Tony Okoro

Intensive care unit (ICU) diaries and the experiences of patients’ families: a grounded theory approach in a lower middle-income country (LMIC)

An intensive care unit (ICU) diary is a relatively new concept in low middle-income countries (LMICs). Illiteracy and socio-cultural inhibitions may affect the use and utility of this intervention, which has p...

Authors: Swagata Tripathy, Swati Priyadarshini Acharya, Alok Kumar Sahoo, Jayanta Kumar Mitra, Kishen Goel, Suma Rabab Ahmad and Upendra Hansdah

First stage psychometric testing of a new instrument for adolescents with visual impairment: the Participation and Activity Inventory for Children and Youth (PAI-CY) 13–17 years

To assess participation of children with visual impairment, the Participation and Activity Inventory for Children and Youth (PAI-CY) was recently developed. This study assessed some initial psychometric proper...

Authors: Ellen B. M. Elsman, Ruth M. A. van Nispen and Gerardus H. M. B. van Rens

Psychometric properties of a custom Patient-Reported Outcomes Measurement Information System (PROMIS) physical function short form and worst stiffness numeric rating scale in tenosynovial giant cell tumors

The purpose of this study was to evaluate the psychometric properties of the PROMIS-Physical Function (PF) and Worst Stiffness Numeric Rating Scale (NRS) among patients with tenosynovial giant cell tumors (TGCT).

Authors: Rebecca M. Speck, Xin Ye, Nicholas M. Bernthal and Heather L. Gelhorn

Patient-reported quality-of-life outcomes in relation to provider-assessed adverse events during head and neck radiotherapy

To assess the relationship between patient-reported quality-of-life (QOL) outcomes and provider-assessed adverse events (AEs) during head-and-neck (H&N) radiotherapy (RT).

Authors: Joshua R. Niska, Cameron S. Thorpe, Michele Y. Halyard, Angelina D. Tan, Pamela J. Atherton, Amylou C. Dueck, Samir H. Patel and Jeff A. Sloan

Health-related quality of life, self-reported impairments and activities of daily living in relation to muscle function in post-polio syndrome

The symptoms of post-polio syndrome (PPS) and its resulting disabilities can affect quality of life and the ability to perform daily activities. No study has comprehensively analysed how various patient-report...

Authors: Vanya Gocheva, Patricia Hafner, Anna-Lena Orsini, Simone Schmidt, Sabine Schaedelin, Nicole Rueedi, Daniela Rubino-Nacht, Peter Weber and Dirk Fischer

Patient-reported outcome instruments used in immune-checkpoint inhibitor clinical trials in oncology: a systematic review

Immune-checkpoint inhibitors (ICI) have shown significant benefits for overall survival across various cancer types. Patient-reported outcomes (PROs) are assessed in clinical trials as a measure of efficacy. H...

Authors: Sara Colomer-Lahiguera, Denise Bryant-Lukosius, Sarah Rietkoetter, Lorraine Martelli, Karin Ribi, Donna Fitzpatrick-Lewis, Diana Sherifali, Angela Orcurto, Rosalyn Juergens and Manuela Eicher

Validation of the 3-item What Engagement Looks Like (WELL) scale in patients with diabetes

Patients’ behaviors play a key role in chronic disease management, but how effective they are may depend on how engaged they feel. The objective was to develop a short measure of how much patients felt engaged...

Authors: Suzanne Brodney, K. D. Valentine, Floyd J. Fowler Jr and Michael J. Barry

A multicenter paper-based and web-based system for collecting patient-reported outcome measures in patients undergoing local treatment for prostate cancer: first experiences

To give an overview of the multicenter Prostate Cancer Outcomes (PCO) study, involving paper-based and web-based collection of patient-reported outcome measures (PROM) in patients undergoing local treatment fo...

Authors: Christoph Kowalski, Rebecca Roth, Günther Carl, Günter Feick, Alisa Oesterle, Andreas Hinkel, Thomas Steiner, Marko Brock, Björn Kaftan, Rainer Borowitz, Niko Zantl, Axel Heidenreich, Andreas Neisius, Christopher Darr, Christian Bolenz, Burkhard Beyer…

Development of an electronic patient-reported outcome measure (ePROM) system to aid the management of patients with advanced chronic kidney disease

Effective management of patients with chronic kidney disease (CKD) relies on timely detection of clinical deterioration towards end stage kidney failure. We aimed to design an electronic Patient-Reported Outco...

Authors: Derek Kyte, Nicola Anderson, Ram Auti, Olalekan Lee Aiyegbusi, Jon Bishop, Andrew Bissell, Elizabeth Brettell, Melanie Calvert, Marie Chadburn, Paul Cockwell, Mary Dutton, Helen Eddington, Elliot Forster, Gabby Hadley, Natalie J. Ives, Louise Jackson…

A prospective study to validate the functional assessment of cancer therapy (FACT) for epidermal growth factor receptor inhibitor (EGFRI)-induced dermatologic toxicities FACT-EGFRI 18 questionnaire: SWOG S1013

Papulopustular rash is a common class effect of epidermal growth factor receptor inhibitors (EGFRI) that can affect patients’ health-related quality of life and cause disruptions to treatment. SWOG S1013 (NCT0...

Authors: Siu-Fun Wong, Joseph M. Unger, James L. Wade III, Lynne I. Wagner, Mario E. Lacouture, Keisha C. Humphries, Anna Moseley, Kathryn Arnold, Mario R. Velasco Jr, Justin D. Floyd, Benjamin T. Esparaz, Afsaneh Barzi, Heinz-Josef Lenz, Marianna Koczywas, Shaker Dakhil, Gary V. Burton…

A real-world analysis of patient-reported outcomes in patients with migraine by preventive treatment eligibility status in the US and Europe

Migraine has a severe impact on health-related quality of life (HRQoL) affecting physical, emotional, and social aspects of daily living of an individual. Preventive treatment has been demonstrated to improve ...

Authors: Janet H. Ford, Shonda A. Foster, Russell M. Nichols, Antje Tockhorn-Heidenreich, Wenyu Ye, James Jackson and Sarah Cotton

EQ-5D: a plea for accurate nomenclature

Between 1987 and 1990, the EuroQol Group developed a 5-dimension health-related quality of life instrument, originally known as ‘the EuroQol instrument’, which since 1995 has been called the ‘EQ-5D’. For sever...

Authors: Richard Brooks, Kristina S. Boye and Bernhard Slaap

The impact of patient-reported outcome data from clinical trials: perspectives from international stakeholders

Patient-reported outcomes (PROs) are increasingly collected in clinical trials as they provide unique information on the physical, functional and psychological impact of a treatment from the patient’s perspect...

Authors: Samantha Cruz Rivera, Christel McMullan, Laura Jones, Derek Kyte, Anita Slade and Melanie Calvert

Evaluation of the usefulness of EQ-5D as a patient-reported outcome measure using the Paretian classification of health change among patients with chronic heart failure

The aim of this study was to evaluate the usefulness of EQ-5D as a patient-reported outcome measure using different analytical methods. Especially we used the Paretian Classification of Health Change, to see i...

Authors: Åsa Jonsson, Lotti Orwelius, Ulf Dahlstrom and Margareta Kristenson

Randomized comparative study of child and caregiver responses to three software functions added to the Japanese version of the electronic Pediatric Quality of Life Inventory (ePedsQL) questionnaire

Patient-reported outcomes (PROs) refer to any report of the status of a patient’s health condition, health behavior, or experience with healthcare directly from the patient, without interpretation of the patie...

Authors: Iori Sato, Mariko Sakka, Takafumi Soejima, Sachiko Kita and Kiyoko Kamibeppu

Simple change in logistic procedure improves response rate to QOL assessment: a report from the Japan Children’s Cancer Group

Reducing non-completion of quality-of-life assessment in clinical trials is an important challenge in obtaining accurate data and unbiased interpretation of patients’ quality-of-life for each regimen. We evalu...

Authors: Iori Sato, Takafumi Soejima, Yasushi Ishida, Miho Maeda, Katsuyoshi Koh and Kiyoko Kamibeppu

Personalized symptom management: a quality improvement collaborative for implementation of patient reported outcomes (PROs) in ‘real-world’ oncology multisite practices

Little research has focused on implementation of electronic Patient Reported Outcomes (e-PROs) for meaningful use in patient management in ‘real-world’ oncology practices. Our quality improvement collaborative...

Authors: Doris Howell, Zeev Rosberger, Carole Mayer, Rosanna Faria, Marc Hamel, Anne Snider, Denise Bryant Lukosius, Nicole Montgomery, Mindaugas Mozuraitis and Madeline Li

Translation and cultural adaptation of EORTC QLQ-LC 29 into Nepalese language for lung cancer patients in Nepal

The quality of life (QoL) of patients with lung cancer (LC) may be affected by disease-related limitations such as patients’ functioning, the severity of symptoms, financial problems resulting along with the s...

Authors: Sunil Shrestha, Sudip Shrestha, Bhuvan KC, Binaya Sapkota, Anil Khadka, Saval Khanal and Michael Koller

Down syndrome and oral health: mothers’ perception on their children’s oral health and its impact

Individuals with Down syndrome exhibit particular oro-facial characteristics that may increase their risk of oral health problems. However, there is little research on the oral health of children and adults wi...

Authors: AlBandary H. AlJameel, Richard G. Watt, Georgios Tsakos and Blánaid Daly

PROMIS-deaf profile measure: cultural adaptation and psychometric validation in American sign language

Authors: P. Kushalnagar, R. Paludneviciene, M. Kallen, S. Atcherson and D. Cella

Adaptation and validation of the quality of life assessment of the Cambridge pulmonary hypertension outcome review (CAMPHOR) for Brazil

Pulmonary Hypertension (PH) impacts negatively on patients’ health-related quality of life (HRQoL). The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) was the first PH-specific and validated instrum...

Authors: Ricardo Amorim Corrêa, Monica Corso Pereira, Mariana Ferreira Bizzi, Rafael W. R. de Oliveira, Camila Farnese Rezende, Bruna Cristina Marabita Tavares de Oliveira, Alice Heaney, Stephen P. McKenna and Antonio Ribeiro-Oliveira Jr

Describing the emotional exhaustion, depersonalization, and low personal accomplishment symptoms associated with Maslach Burnout Inventory subscale scores in US physicians: an item response theory analysis

Current US health policy discussions regarding physician burnout have largely been informed by studies employing the Maslach Burnout Inventory (MBI); yet, there is little in the literature focused on interpret...

Authors: Keri J. S. Brady, Pengsheng Ni, R. Christopher Sheldrick, Mickey T. Trockel, Tait D. Shanafelt, Susannah G. Rowe, Jeffrey I. Schneider and Lewis E. Kazis

International Hip Outcome Tool (12-items) as health-related quality-of-life measure in osteoarthritis: validation of Greek version

The 12-item International Hip Outcome Tool (iHOT12) is a patient-reported outcome (PRO) designed to evaluate quality of life. We assessed the psychometric properties of the Greek version (iHOT12-Gr) in hip ost...

Authors: Sophia Stasi, Magdalini Stamou, George Papathanasiou, Paraskevi Frantzeskaki, Emmanouil Kanavas, George Evaggelou-Sossidis, Adamantios Gouskos, Andreas Palantzas, Kyriakos Poursanidis and George A. Macheras

Pattern of recovery and outcomes of patient reported physical function and pain interference after ankle fusion: a retrospective cohort study

Research on outcomes after ankle fusion focuses on basic activities of daily living, fusion rates, and gait parameters. Little has been reported on the patient’s perspective after surgery. The purpose of this ...

Authors: Jessica M. Kohring, Jeffrey R. Houck, Irvin Oh, Adolf S. Flemister, John P. Ketz and Judith F. Baumhauer

Can Patient-Reported Outcomes Measurement Information System® (PROMIS) measures accurately enhance understanding of acceptable symptoms and functioning in primary care?

Value-based healthcare models will require prioritization of the patient’s voice in their own care toward better outcomes. The Patient-Reported Outcomes Measurement Information System® (PROMIS) gives patients ...

Authors: Ryan P. Jacobson, Daniel Kang and Jeff Houck

Use of a modified World Café process to discuss and set priorities for a Community of Practice supporting implementation of ReQoL a new mental health and quality of life Patient Reported Outcome Measure (PROM)

Authors: Elizabeth Taylor Buck, Christine M. Smith, Amanda Lane, Anju Devianee Keetharuth, Tracey Young and Jo Cooke

The long-term course of fatigue following breast cancer diagnosis

Fatigue following breast cancer is a well-known problem, with both high and persistent prevalence. Previous studies suffer from lack of repeated measurements, late recruitment and short periods of follow-up. T...

Authors: Karin Biering, Morten Frydenberg, Helle Pappot and Niels Henrik Hjollund

The Cystic Fibrosis Impact Questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis

Patients with cystic fibrosis (CF) experience significant disease burden, including progressive pulmonary decline and reduced survival. This multicenter qualitative study was conducted to develop a new patient...

Authors: Kelly P. McCarrier, Mariam Hassan, Paul Hodgkins, Ellison Suthoff, Lisa J. McGarry and Mona L. Martin

The responsiveness of goal attainment scaling using just one goal in controlled clinical trials: an exploratory analysis

Goal Attainment Scaling (GAS) is an individualized outcome measure that allows the setting of personalized treatment goals. We compared the responsiveness of GAS when individuals set only one goal instead of t...

Authors: Lisa McGarrigle and Kenneth Rockwood

Advances in Patient Reported Outcomes: Integration and Innovation

Authors:

Reference values for and interpretation of the Singapore Caregiver Quality of Life Scale: a quantile regression approach

The Singapore Caregiver Quality of Life Scale (SCQOLS) was recently developed and validated in two languages - English and Chinese. The total and domain scores are scaled to range from 0 to 100. However, the s...

Authors: Yin Bun Cheung, Shirlyn H. S. Neo, Grace M. Yang, Irene Teo, Geok Ling Lee, Debra L. M. Qu, Audrey R. X. Koh, Julian Thumboo and Hwee Lin Wee

Patients’ perspectives of endometriosis-related fatigue: qualitative interviews

Endometriosis-related fatigue is common and negatively impacts multiple areas of many women’s lives, particularly in day-to-day activities, social activities, physical activities, mood and emotions, relationsh...

Authors: Dana DiBenedetti, Ahmed M. Soliman, Catherine Gupta and Eric S. Surrey

Psychometric evaluation of the Chinese version of the Toronto Hospital Alertness Test

Alertness is an important part of attention which is different from the opposite of sleepiness. This study aimed to translate and assess the measurement properties of the Toronto Hospital Alertness Test (THAT)...

Authors: Sha Li, Daniel Yee Tak Fong, Janet Yuen Ha Wong, Kate Wilkinson, Colin Shapiro, Edmond Pui Hang Choi, Bradley McPherson, Cindy Lo Kuen Lam and Mary Sau Man Ip

Development of the neurotrophic keratopathy questionnaire: qualitative research

Neurotrophic keratopathy/keratitis (NK) is a rare disease of the cornea that can lead to anatomical loss of the eye. Little is known about the NK experience from the patients’ perspective. The objectives of th...

Authors: Lindsey T. Murray, Julie McCormack, Ioana Grobeiu, Ingela Wiklund, Miriam Kimel and Floortje Van Nooten