Articles

Establishing content-validity of a disease-specific health-related quality of life instrument for patients with chronic hypersensitivity pneumonitis

Chronic Hypersensitivity Pneumonitis (CHP) is caused by an immune mediated response in the lung tissue after exposure to an inhaled environmental antigenic stimulant. We previously documented the ways in which...

Authors: Kerri I. Aronson, Maha Ali, Evgeniya Reshetynak, Robert J. Kaner, Fernando J. Martinez, Monika M. Safford and Laura C. Pinheiro

Patient-led use of patient-reported outcome measure in self-Management of a Rotator Cuff Injury

The patient is the person who experiences both the processes and the outcomes of care. Information held by the patient is vital for clinical and self-management, improving health outcomes, delivery of care, or...

Authors: Maria J. Santana and Darrell J. Tomkins

Vision-related quality of life in adults with severe peripheral vision loss: a qualitative interview study

Existing patient-reported outcome (PRO) measures may not be relevant to the full range of functional and vision-related quality of life (VR-QOL) concerns of individuals with vision impairment due to severe per...

Authors: Ryan Lange, Abigail Kumagai, Sara Weiss, Katherine B. Zaffke, Sherry Day, Donna Wicker, Ashley Howson, K. Thiran Jayasundera, Lori Smolinski, Christina Hedlich, Paul P. Lee, Robert W. Massof, Joan A. Stelmack, Noelle E. Carlozzi and Joshua R. Ehrlich

The impact of moderate and severe asthma exacerbations on quality of life: a post hoc analysis of randomised controlled trial data

This paper reports the duration of moderate and severe exacerbations in patients with house dust mite induced allergic asthma and the impact on patients’ quality of life.

Authors: Andrew Briggs, Shuaib Nasser, Eva Hammerby, Sarah Buchs and J. Christian Virchow

Development of a symptom menu to facilitate Goal Attainment Scaling in adults with Down syndrome-associated Alzheimer’s disease: a qualitative study to identify meaningful symptoms

As life expectancy of people with Down syndrome (DS) increases, so does the risk of Alzheimer’s disease (AD). Identifying symptoms and tracking disease progression is especially challenging whenever levels of ...

Authors: Kari Knox, Justin Stanley, James A. Hendrix, Hampus Hillerstrom, Taylor Dunn, Jillian Achenbach, Brian A. Chicoine, Florence Lai, Ira Lott, Sanja Stanojevic, Susan E. Howlett and Kenneth Rockwood

Assessing the acceptability, reliability, and validity of the EORTC Quality of Life Questionnaire (QLQ-C30) in Kenyan cancer patients: a cross-sectional study

In oncology practice, eliciting the patient’s perspective on their quality of life (QOL) adds important information and value to their treatment and care. The European Organization for Research and Treatment o...

Authors: Jasmine Davda, Hillary Kibet, Emmah Achieng, Lawrence Atundo and Truphena Komen

Patient-reported burden of hereditary transthyretin amyloidosis on functioning and well-being

Hereditary transthyretin (hATTR) amyloidosis is a rare, systemic, progressive, and life-threatening disease in which transthyretin proteins misfold and aggregate as insoluble amyloid deposits, disrupting nervo...

Authors: Andrew Lovley, Kimberly Raymond, Spencer D. Guthrie, Michael Pollock, Vaishali Sanchorawala and Michelle K. White

Impact of comorbidities and treatment burden on general well-being among women’s cancer survivors

Gains in cancer detection and treatment have meant that more patients are now living with both cancer and other chronic health conditions, which may become burdensome. We used the Patient Experience with Treat...

Authors: R. T. Anderson, D. T. Eton, F. T. Camacho, E. M. Kennedy, C. M. Brenin, P. B. DeGuzman, K. F. Carter, T. Guterbock, K. J. Ruddy and W. F. Cohn

Translation and content validity of the Dutch Impact of Vision Impairment questionnaire assessed by Three-Step Test-Interviewing

Patients suffering from exsudative retinal diseases may experience severe central vision loss and this might have impact on their daily activities and quality of life. To measure the disabilities these patient...

Authors: T. P. Rausch – Koster, A. J. van der Ham, C. B. Terwee, F. D. Verbraak, G. H. M. B. van Rens and R. M. A. van Nispen

Correction to: Content validity of a sleep numerical rating scale and a sleep diary in adults and adolescents with moderate-to-severe atopic dermatitis

An amendment to this paper has been published and can be accessed via the original article.

Authors: Carla Dias-Barbosa, Rodolfo Matos, Margaret Vernon, Colleen E. Carney, Andrew Krystal and Jorge Puelles

Establishing a common metric for patient-reported outcomes in cancer patients: linking patient reported outcomes measurement information system (PROMIS), numerical rating scale, and patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

Researchers and clinicians studying symptoms experienced by people with cancer must choose from various scales. It would be useful to know how the scores on one measure translate to another.

Authors: Minji K. Lee, Benjamin D. Schalet, David Cella, Kathleen J. Yost, Amy C. Dueck, Paul J. Novotny and Jeff A. Sloan

Selection and validation of a classification system for a child-centred preference-based measure of oral health-related quality of life specific to dental caries

Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) is a child-centred caries-specific quality of life measure. This study aimed to select, and validate with children, a classification system...

Authors: Helen J. Rogers, Fiona Gilchrist, Zoe Marshman, Helen D. Rodd and Donna Rowen

Validity and analysis of the Diabetes Injection Device Preference Questionnaire (DID-PQ)

The Diabetes Injection Device Preference Questionnaire (DID-PQ) was designed to assess patient preference between two non-insulin injection devices. In a recent crossover study, people with type 2 diabetes (T2...

Authors: Kristina S. Boye, Louis S. Matza, Brooke M. Currie and Karin S. Coyne

Development and internal validation of a predictive risk model for anxiety after completion of treatment for early stage breast cancer

To develop a predictive risk model (PRM) for patient-reported anxiety after treatment completion for early stage breast cancer suitable for use in practice and underpinned by advances in data science and risk ...

Authors: Jenny Harris, Edward Purssell, Victoria Cornelius, Emma Ream, Anne Jones and Jo Armes

Patient experiences with hypertrophic cardiomyopathy: a conceptual model of symptoms and impacts on quality of life

Hypertrophic cardiomyopathy (HCM) is a primary myocardial disorder defined by left ventricular hypertrophy that cannot be explained by another cardiac or systemic disease. There is a general lack of knowledge ...

Authors: Erica Zaiser, Amy J. Sehnert, Ashley Duenas, Sara Saberi, Ella Brookes and Matthew Reaney

Selecting, implementing and evaluating patient-reported outcome measures for routine clinical use in cancer: the Cancer Care Ontario approach

The use of Patient-Reported Outcome Measures (PROMs) in routine clinical care can help ensure symptoms are identified, acknowledged and addressed. In 2007, the provincial cancer agency, Cancer Care Ontario, be...

Authors: Nicole Montgomery, Doris Howell, Zahra Ismail, Susan J. Bartlett, Michael Brundage, Denise Bryant-Lukosius, Monika Krzyzanowska, Lesley Moody, Claire Snyder and Lisa Barbera

Content validity of a sleep numerical rating scale and a sleep diary in adults and adolescents with moderate-to-severe atopic dermatitis

The intense itching associated with atopic dermatitis (AD) often causes patients to experience severe sleep disturbance. Here, we describe the results of a two-phase concept elicitation and cognitive interview...

Authors: Carla Dias-Barbosa, Rodolfo Matos, Margaret Vernon, Colleen E. Carney, Andrew Krystal and Jorge Puelles

Psychometric evaluation of the DAILY EATS questionnaire in individuals living with obesity

Physiological and behavioral factors including hunger, satiety, food intake, and cravings are health determinants contributing to obesity. Patient-reported outcome (PRO) measures focused on eating-related fact...

Authors: John Fastenau, Heather Rozjabek, Shanshan Qin, Lori McLeod, Lauren Nelson, Jia Ma and Nimanee Harris

PROMIS® Health Organization (PHO) 2020 Conference Toward Patient-Centered Care: PROMIS Implementations and Advances Abstracts

Authors:

Ecological momentary assessment versus retrospective assessment for measuring change in health-related quality of life following cardiac intervention

Measuring change in health-related quality-of-life (HRQoL) is important to assess the impact of disease and/or treatment. Ecological momentary assessment (EMA) comprises the repeated assessment of momentary HR...

Authors: Tom H. Oreel, Philippe Delespaul, Iris D. Hartog, José P. S. Henriques, Justine E. Netjes, Alexander B. A. Vonk, Jorrit Lemkes, Michael Scherer-Rath, Hanneke W. M. van Laarhoven, Mirjam A. G. Sprangers and Pythia T. Nieuwkerk

Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies

To evaluate the psychometric and measurement properties of two patient-reported outcome instruments, the menstrual pictogram superabsorbent polymer-containing version 3 (MP SAP-c v3) and Uterine Fibroid Daily ...

Authors: Claudia Haberland, Anna Filonenko, Christian Seitz, Matthias Börner, Christoph Gerlinger, Helen Doll and Dorothea Wessiepe

The needs of key-stakeholders for evaluating client’s experienced quality of home care: a qualitative approach

To optimize home care, it is essential to determine how care recipients experience quality of care. Traditionally, quality of care is measured with normative quality indicators such as safety, efficiency, or p...

Authors: Roy Haex, Theresa Thoma-Lürken, Sandra Zwakhalen and Anna Beurskens

Symptom burden and health-related quality of life impacts of smoldering multiple myeloma: the patient perspective

Smoldering multiple myeloma (SMM) is an early form of multiple myeloma (MM). SMM is typically considered asymptomatic, and research on how it affects health-related quality of life (HRQoL) is limited. This stu...

Authors: Milenka Jean-Baptiste, Katharine S. Gries, William R. Lenderking and John Fastenau

Validity and reliability testing of the Toddler and Infant (TANDI) Health Related Quality of Life instrument for very young children

Despite the high burden of disease in younger children there are few tools specifically designed to estimate Health Related Quality of Life (HRQoL) in children younger than 3 years of age. A previous paper des...

Authors: Janine Verstraete, Lebogang Ramma and Jennifer Jelsma

Quality of life among patients seeking treatment for substance use disorder, as measured with the EQ-5D-3L

There is a need to assess the quality of treatment for Substance Use Disorder (SUD), and document SUD patients’ health-related quality of life (HRQoL). The study aims to describe Norwegian SUD patients’ HRQoL ...

Authors: Kim Rand, Espen Ajo Arnevik and Espen Walderhaug

Development of a patient-reported outcome measure (PROM) and change measure for use in early recovery following hip or knee replacement

Hip and knee replacement are effective procedures for end-stage arthritis that has not responded to medical management. However, until now, there have been no validated, patient-reported tools to measure early...

Authors: Louise H. Strickland, David W. Murray, Hemant G. Pandit and Crispin Jenkinson

The relationship of personal budgets with independence, participation and quality of life; a secondary analysis of survey data using propensity score matching

Personal budgets for social and health care have been introduced in many European countries over recent decades. The assumption is that people with a personal budget are able to purchase care that matches thei...

Authors: Anna Maria Marangos, Jurjen Iedema, Mirjam de Klerk, Isolde Woittiez and Peter P. Groenewegen

Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures

Within current literature and practice, the category of patient-reported outcome (PRO) measures has been expanded into the broader category of clinical outcome assessments (COAs), which includes the subcategor...

Authors: Shawn McKown, Catherine Acquadro, Caroline Anfray, Benjamin Arnold, Sonya Eremenco, Christelle Giroudet, Mona Martin and Dana Weiss

The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial

A randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electr...

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

User experiences on implementation of patient reported outcome measures (PROMs) in a Haematological outpatient clinic

PROMs can help healthcare professionals gain an improved understanding of patients’ physical burdens, functional levels, and (health-related) quality of life throughout disease and medical treatment. The aim o...

Authors: Stine Thestrup Hansen, Mette Kjerholt, Sarah Friis Christensen, John Brodersen and Bibi Hølge-Hazelton

Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain

Endometriosis is a common problem in women of reproductive age and has impacts on health-related quality of life and productivity. Fatigue is an important part of the burden of endometriosis, it is not often i...

Authors: Robin Pokrzywinski, Ahmed M. Soliman, Eric Surrey, Michael C. Snabes and Karin S. Coyne

Capturing patient experience: does quality-of-life appraisal entail a new class of measurement?

Two decades of research on quality-of-life (QOL) appraisal have demonstrated links between patient experience and health outcomes and have accounted for both intra-individual change and inter-individual differ...

Authors: Carolyn E. Schwartz, Roland B. Stark and Bruce D. Rapkin

Development and evaluation of the Singapore Caregiver Quality of Life Scale - Dementia

To develop and evaluate a measurement scale for multi-domain assessment of the quality of life of family caregivers of persons with dementia (PWD) in Singapore, a multi-ethic society in South-East Asia where E...

Authors: Yin Bun Cheung, Irene Teo, Wee Shiong Lim, Allyn Hum, Shirlyn H. S. Neo, Grace M. Yang, Geok Ling Lee, Gretchen Tan and Dennis C. C. Seow

Use of the patient-reported outcomes measurement information system (PROMIS®) to assess late-onset Pompe disease severity

Patient-Reported Outcomes provide an opportunity for patients to establish dialogue with pharmaceutical or biotechnology companies about their health conditions without interpretation by a clinician or anyone ...

Authors: Melodi Harfouche, Priya S. Kishnani, Eva Krusinska, Jamie Gault, Sheela Sitaraman, Amanda Sowinski, Irina Katz, Stephanie Austin, Margi Goldstein and Andrew E. Mulberg

Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder

The Elements of Desire Questionnaire (EDQ) is a patient-reported outcome (PRO) measure developed to evaluate sexual desire and was included in two identically designed phase 3 clinical trials (RECONNECT) as an...

Authors: Dennis A. Revicki, Stanley E. Althof, Leonard R. Derogatis, Sheryl A. Kingsberg, Hilary Wilson, Amama Sadiq, Julie Krop, Robert Jordan and Johna Lucas

Dutch translation and linguistic validation of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™)

The U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) is a library of items for assessing symptomatic adverse events by patie...

Authors: Evalien Veldhuijzen, Iris Walraven, Sandra A. Mitchell, Elizabeth Yohe Moore, Shawn M. McKown, Matthew Lauritzen, Katherine J. Kim, José S. A. Belderbos and Neil K. Aaronson

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures

Evolving regulatory guidelines recommend routine assessment of the acceptability of pediatric oral medicines throughout clinical development processes. However, such assessment is problematic owing to a lack o...

Authors: Diane M. Turner-Bowker, Kristina An Haack, Meaghan Krohe, Andrew Yaworsky, Norma Vivas, Masami Kelly, Godhuli Chatterjee, Emily Chaston, Erin Mann and Matthew Reaney

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