Articles

Proceedings of the 4th Annual PROMIS® Health Organization Conference: Global Advances in Methodology and Clinical Science

Authors:

Depressive symptom prevalence after intracerebral hemorrhage: a multi-center study

Depressive symptoms in patients with intracerebral hemorrhage (ICH) are common and are associated with worse outcomes. It is not well described how often depressive symptoms are ascertained and treated in larg...

Authors: Brandon A. Francis, Jennifer Beaumont, Matthew B. Maas, Eric M. Liotta, David Cella, Shyam Prabhakaran, Jane Holl, Abel Kho and Andrew M. Naidech

Feasibility of collecting retrospective patient reported outcome measures (PROMs) in emergency hospital admissions

Outcome of emergency admissions is usually limited to mortality with little attempt to capture the views of health status of survivors. This is because of the challenge of determining patient reported outcome ...

Authors: Esther Kwong and Nick Black

How do depressed patients evaluate their quality of life? A qualitative study

This is a qualitative study that aims to investigate the effect of depressive status on responses to items on the WHO quality of life assessment instrument (WHOQOL-Bref), comparing which aspects of the individ...

Authors: Jacques J. Zimmermann, Maria Lucia Tiellet Nunes and Marcelo P. Fleck

Standard setting for a novel esophageal conduit questionnaire: CONDUIT Report Card

The purpose of this study was to establish the clinical thresholds for five domains (dysphagia, reflux, dumping-hypoglycemia, dumping-GI symptoms, pain) to support the use of the CONDUIT questionnaire as a scr...

Authors: Minji K. Lee, Kathleen J. Yost, Karlyn E. Pierson, Amy J. Schrandt, Bobbie J. Skaare and Shanda H. Blackmon

Patient centered research to improve community involvement (PaRTICIpate) in diabetes self-management: a conference series for developing collaborations between researchers, stakeholders, and patients

A patient-centered approach to research development is important to the creation of research evidence that is meaningful and beneficial to patients. Collaboration between patients, stakeholders, and researcher...

Authors: Ashley S. Crumby, Erin R. Holmes and Meagen Rosenthal

Mastering life together - symptom management, views, and experiences of relatives of persons with CPTSD: a grounded theory study

Complex posttraumatic stress disorder is described as a chronic condition with several severe and concurrent symptoms. Symptoms influence and impair not only the affected individuals but also their social surr...

Authors: Manuel P. Stadtmann, Andreas Maercker, Jochen Binder and Wilfried Schnepp

Health-related quality of life, culture and communication: a comparative study in children with cancer in Argentina and Sweden

Malignant disorders in childhood are life-threatening conditions, and issues regarding the children’s health-related quality of life (HRQOL) are crucial in paediatric oncology. The overall aim of this study wa...

Authors: Emelie Stenmarker, Karin Mellgren, Mónica Matus, Anna Schroder Hakansson and Margaretha Stenmarker

Important differences and meaningful changes for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)

We estimated clinically important, group-level differences in self-reported cognitive function for the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) instrument. We also investigated ind...

Authors: M L Bell, H M Dhillon, V J Bray and J L Vardy

The facilitators and barriers to implementing patient reported outcome measures in organisations delivering health related services: a systematic review of reviews

There is increasing interest in using Patient Reported Outcome Measures (PROMs) within organisations delivering health related services. However, organisations have had mixed success in implementing PROMs and ...

Authors: Alexis Foster, Liz Croot, John Brazier, Janet Harris and Alicia O’Cathain

The association between pregnancy, pelvic girdle pain and health-related quality of life – a comparison of two instruments

The main purposes in this cross-sectional study were to study the impact of pregnancy and pelvic girdle pain (PGP) on health related quality of life (HRQoL), by comparing the scores on different domains of two...

Authors: Pernille Stendal Robinson, Arun Prasad Balasundaram, Nina Køpke Vøllestad and Hilde Stendal Robinson

Psychometric evaluation of the Diabetes Injection Device Experience Questionnaire (DID-EQ) and Diabetes Injection Device Preference Questionnaire (DID-PQ)

Previous research has examined patient perceptions of insulin injection devices. However, a range of injectable medications other than insulin are now used to treat type 2 diabetes. No patient-reported outcome...

Authors: Louis S. Matza, Katie D. Stewart, Rosirene Paczkowski, Karin S. Coyne, Brooke Currie and Kristina S. Boye

How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis

In this paper, we report the findings of a realist synthesis that aimed to understand how and in what circumstances patient reported outcome measures (PROMs) support patient-clinician communication and subsequ...

Authors: Joanne Greenhalgh, Kate Gooding, Elizabeth Gibbons, Sonia Dalkin, Judy Wright, Jose Valderas and Nick Black

Development of the Diabetes Injection Device Experience Questionnaire (DID-EQ) and Diabetes Injection Device Preference Questionnaire (DID-PQ)

Previous research has examined patient perceptions of insulin injection devices. However, injectable medications other than insulin are increasingly used to treat type 2 diabetes, including GLP-1 receptor agon...

Authors: Louis S. Matza, Kristina S. Boye, Katie D. Stewart, Rosirene Paczkowski, Jessica Jordan and Lindsey T. Murray

Literature review to assemble the evidence for response scales used in patient-reported outcome measures

In the development of patient-reported outcome (PRO) instruments, little documentation is provided on the justification of response scale selection. The selection of response scales is often based on the devel...

Authors: Katharine Gries, Pamela Berry, Magdalena Harrington, Mabel Crescioni, Mira Patel, Katja Rudell, Shima Safikhani, Sheryl Pease and Margaret Vernon

Response scale selection in adult pain measures: results from a literature review

The purpose of this literature review was to examine the existing patient-reported outcome measurement literature to understand the empirical evidence supporting response scale selection in pain measurement fo...

Authors: Shima Safikhani, Katharine S. Gries, Jeremiah J. Trudeau, David Reasner, Katja Rüdell, Stephen Joel Coons, Elizabeth Nicole Bush, Jennifer Hanlon, Lucy Abraham and Margaret Vernon

Literature review to characterize the empirical basis for response scale selection in pediatric populations

Despite the importance of response option selection for patient-reported outcome measures, there seems to be little empirical evidence for the selected scale type. This article provides an overview of the publ...

Authors: April N. Naegeli, Jennifer Hanlon, Katharine S. Gries, Shima Safikhani, Anna Ryden, Mira Patel, Mabel Crescioni and Margaret Vernon

PRO-based follow-up as a means of self-management support – an interpretive description of the patient perspective

There is an increasing focus on the use of patient-reported outcome (PRO) measures to improve the quality and effectiveness of health care. PRO-based follow-up is a new model of service delivery, where the pat...

Authors: Caroline Trillingsgaard Mejdahl, Liv Marit Valen Schougaard, Niels Henrik Hjollund, Erik Riiskjær, Sally Thorne and Kirsten Lomborg

Consequences of screening in abdominal aortic aneurysm: development and dimensionality of a questionnaire

In interview studies, men under surveillance for screening-detected abdominal aortic aneurysms have reported ambivalence towards this diagnosis: the knowledge was welcomed together with worries, feelings of an...

Authors: John Brodersen, Anders Hansson, Minna Johansson, Volkert Siersma, Marcus Langenskiöld and Monica Pettersson

Design and introduction of a quality of life assessment and practice support system: perspectives from palliative care settings

Quality of life (QOL) assessment instruments, including patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs), are increasingly promoted as a means of enabling clinicians t...

Authors: Richard Sawatzky, Esther Laforest, Kara Schick-Makaroff, Kelli Stajduhar, Sheryl Reimer-Kirkham, Marian Krawczyk, Joakim Öhlén, Barbara McLeod, Neil Hilliard, Carolyn Tayler and S. Robin Cohen

Integrating the patient voice with clinician reports to identify a hepatocellular carcinoma-specific subset of treatment-related symptomatic adverse events

Incorporating patient reporting of symptomatic adverse events (AEs) is important in evaluating safety and tolerability in cancer clinical trials. The Patient-Reported Outcomes version of the Common Terminology...

Authors: Rebecca M. Speck, William R. Lenderking and James W. Shaw

Patient reported outcomes – experiences with implementation in a University Health Care setting

Patient-reported outcomes (PROs) have traditionally been implemented through a manual process of paper and pencil with little standardization throughout a Healthcare System. Each practice has asked patients sp...

Authors: Joshua Biber, Dominik Ose, Jenny Reese, Anna Gardiner, Julio Facelli, Joshua Spuhl, Darrel Brodke, Vivian S. Lee, Rachel Hess and Howard Weeks

Patients’ experience of recurrent/metastatic head and neck squamous cell carcinoma and their perspective on the EORTC QLQ-C30 and QLQ-H&N35 questionnaires: a qualitative study

Head and neck squamous cell carcinoma (HNSCC) and its associated treatments may affect all aspects of patients’ health-related quality of life (HRQoL). Although the EORTC QLQ-H&N35 is regularly administered to...

Authors: Arnold Degboe, Sarah L. Knight, Katarina Halling, Andrew Trigg, Tamara Al-Zubeidi, Natalie Aldhouse, Helen Kitchen, Lori Wirth and Simon N. Rogers

The feasibility of implementing the ICHOM Standard Set for Hip and Knee Osteoarthritis: a mixed-methods evaluation in public and private hospital settings

There is growing international momentum for standardising patient outcome assessment and using patient-reported outcome measures (PROMs) to capture outcomes that matter to patients. The International Consortiu...

Authors: Ilana N. Ackerman, Bernarda Cavka, Jacob Lippa and Andrew Bucknill

Measurement properties of the German version of the IKDC subjective knee form (IKDC-SKF)

To examine the measurement properties of the German International Knee Documentation Committee Subjective Knee Form (IKDC-SKF) in knee disorder patients.

Authors: Danica Kümmel, Stefan Preiss, Laurent P. Harder, Michael Leunig and Franco M. Impellizzeri

Burden of renal angiomyolipomas associated with tuberous sclerosis complex: results of a patient and caregiver survey

Tuberous sclerosis complex (TSC) is a rare genetic disorder characterized by benign tumors in multiple organs, including non-cancerous kidney lesions known as renal angiomyolipomas. This study’s objective is t...

Authors: Anne M. Rentz, Anne M. Skalicky, Zhimei Liu, David W. Dunn, Michael D. Frost, Jo Anne Nakagawa, Judith Prestifilippo, Qayyim Said and James W. Wheless

The relationship between comorbidity medication adherence and health related quality of life among patients with cancer

Studies have demonstrated that comorbidities compound the adverse influence of cancer on health-related quality of life (HRQoL). Comorbidities adversely impact adherence to cancer treatment. Additionally, adhe...

Authors: Dana Drzayich Antol, Adrianne Waldman Casebeer, Raya Khoury, Todd Michael, Andrew Renda, Sari Hopson, Aparna Parikh, Alisha Stein, Mary Costantino, Stephen Stemkowski and Mikele Bunce

Health-related quality of life burden of nonalcoholic steatohepatitis: a robust pragmatic literature review

Nonalcoholic steatohepatitis (NASH) is a form of chronic liver disease (CLD): patients have an increased risk of developing cirrhosis, liver failure, and complications (e.g. hepatocellular carcinoma). NASH has...

Authors: Tessa Kennedy-Martin, Jay P. Bae, Rosirene Paczkowski and Emily Freeman

Patient-reported outcomes for patients with metastatic castration-resistant prostate cancer receiving docetaxel and Atrasentan versus docetaxel and placebo in a randomized phase III clinical trial (SWOG S0421)

SWOG S0421 was a large randomized trial comparing docetaxel/prednisone plus placebo (DPP) to docetaxel/prednisone plus atrasentan over 12 cycles for patients with metastatic castration-resistant prostate cance...

Authors: Joseph M. Unger, Katherine Griffin, Gary W. Donaldson, Karen M. Baranowski, Margorie J. Good, Eunicia Reburiano, Maha Hussain, Paul J. Monk, Peter J. Van Veldhuizen, Michael A. Carducci, Celestia S. Higano, Primo N. Lara, Catherine M. Tangen, David I. Quinn, James L. Wade, III…

Development and validation of the Ulcerative Colitis patient-reported outcomes signs and symptoms (UC-pro/SS) diary

The clinical course of ulcerative colitis (UC) and the effects of treatment are assessed through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Ulcerative Colitis Patie...

Authors: Peter D. R. Higgins, Gale Harding, Dennis A. Revicki, Gary Globe, Donald L. Patrick, Kristina Fitzgerald, Hema Viswanathan, Sarah M. Donelson, Brian G. Ortmeier, Wen Hung Chen, Nancy K. Leidy and Kendra DeBusk

Rasch analysis in the development of the NutriQoL® questionnaire, a specific health-related quality of life instrument for home enteral nutrition

Home enteral nutrition (HEN) is a therapeutic method used in patients who are unable to ingest the required amounts of nutrients but retain a functional gastrointestinal tract. The objective of this study was ...

Authors: Antonio Apezetxea, Lourdes Carrillo, Felipe Casanueva, Cristina de la Cuerda, Federico Cuesta, Jose Antonio Irles, Maria Nuria Virgili, Miquel Layola and Luis Lizán

Development and validation of the Crohn’s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary

The clinical course of Crohn’s disease (CD) and the effect of its treatment are monitored through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Crohn’s Disease Patient...

Authors: Peter D. R. Higgins, Gale Harding, Nancy K. Leidy, Kendra DeBusk, Donald L. Patrick, Hema N. Viswanathan, Kristina Fitzgerald, Sarah M. Donelson, Marcoli Cyrille, Brian G. Ortmeier, Hilary Wilson, Dennis A. Revicki and Gary Globe

Care-related Quality of Life of informal caregivers of the elderly after a hip fracture

Reforms in the Dutch healthcare system in combination with the aging of the population will lead to a strong increase in the demand for informal care in the Netherlands. A hip fracture is one of the most impor...

Authors: Cornelis L. P. van de Ree, Kari Ploegsma, Tim A. Kanters, Jan A. Roukema, Mariska A. C. De Jongh and Taco Gosens

Health-related quality of life in colorectal cancer survivors: are there differences between sporadic and hereditary patients?

To compare health-related quality of life (HRQoL) in colorectal cancer (CRC) survivors with sporadic CRC to those with hereditary cancer, specifically Lynch syndrome (LS).

Authors: Allison M. Burton-Chase, Wendy M. Parker, Kirsten M. Donato, Shannon McCormick, Ellen R. Gritz, Christopher I. Amos, Karen H. Lu, Patrick M. Lynch, Miguel A. Rodriguez-Bigas, Y. Nancy You and Susan K. Peterson

Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study

Ulcerative colitis (UC) is associated with lower health-related quality of life (HRQoL), and with disease activity predicting lower HRQoL and worse work-related outcomes. The current study examined the burden ...

Authors: Mary Kaye Willian, Geert D’Haens, Aaron Yarlas and Ashish V. Joshi

A utility valuation study assessing the impact of postprandial glucose control on quality of life of individuals with type 1 or type 2 diabetes

Consideration of health-related quality of life (HRQOL) in diabetes has been associated with long-term and short-term complications such as hypoglycaemia, but not with short-term glucose control. This study ai...

Authors: J. Jendle, A. Sandberg, S. Buchs, P. Swinburn, M. Hadi and L. Å. Levin

Towards the use of mixed methods inquiry as best practice in health outcomes research

Mixed methods research (MMR) has found an increased interest in the field of health outcomes research. Consideration for both qualitative and quantitative perspectives has become key to contextualising patient...

Authors: Antoine Regnault, Tom Willgoss and Skye Barbic

Understanding and measuring symptoms and health status in asthma COPD overlap: content validity of the EXACT and SGRQ

Asthma-chronic obstructive pulmonary disease overlap (ACO) differs from asthma and chronic obstructive pulmonary disease (COPD) in demographics, phenotypic characteristics and outcomes, yet the patient experie...

Authors: Linda Nelsen, Adam Gater, Charlotte Panter, Chloe Tolley, Laurie Lee and Steven Pascoe

Development of the Weight-Related Sign and Symptom Measure

Overweight and obesity have been associated with physical and emotional signs & symptoms. Research has shown that modest weight loss can mitigate some symptoms in individuals with overweight or obesity. This s...

Authors: Meryl Brod, Lise Højbjerre, Kathryn M. Pfeiffer, Robyn Sayner, Henrik H. Meincke and Donald L. Patrick

Content validity and ePRO usability of the BPI-sf and “worst pain” item with pleural and peritoneal mesothelioma

The Brief Pain Inventory-short form (BPI-sf) is widely used in self-reported pain assessment, incorporates pain numeric rating scales (NRS) and is commonly utilized in electronic format in clinical trials, how...

Authors: Heather L. Gelhorn, Sonya Eremenco, Anne M. Skalicky, Zaneta Balantac, Tricia Cimms, Katarina Halling and Chris Sexton

Development of the Impact of Juvenile Metachromatic Leukodystrophy on Physical Activities scale

Metachromatic leukodystrophy (MLD) is a rare disease with three forms based on the age at onset of signs and symptoms. The objective of this study was to develop a caregiver-reported clinical outcome assessmen...

Authors: T. Michelle Brown, Susan Martin, Sheri E. Fehnel and Linda S. Deal

Measurement of alienation among adolescents: construct validity of three scales on powerlessness, meaninglessness and social isolation

Psychological alienation is an important concept in the study of adolescents’ health and behavior but no gold standard for measuring alienation among adolescents exists. There is a need for new scales with hig...

Authors: Signe Boe Rayce, Svend Kreiner, Mogens Trab Damsgaard, Tine Nielsen and Bjørn Evald Holstein

Value of transfusion independence in severe aplastic anemia from patients’ perspectives – a discrete choice experiment

Aplastic anemia is a rare, serious blood disorder due to bone marrow failure to produce blood cells. Transfusions are used to reduce risk of bleeding, infection and relieve anemia symptoms. In severe patients,...

Authors: A. Simon Pickard, Lynn Huynh, Jasmina I. Ivanova, Todor Totev, Sophia Graham, Axel C. Mühlbacher, Anuja Roy and Mei Sheng Duh

Qualitative methods in the development of a parent survey of children’s oral health status

Parents’ perceptions of their 8–17-year-old children’s oral health status were assessed using a sample from diverse dental clinics in Greater Los Angeles County to identify constructs for a survey instrument.

Authors: Carl A. Maida, Marvin Marcus, Ron D. Hays, Ian D. Coulter, Francisco Ramos-Gomez, Steve Y. Lee, Patricia S. McClory, Laura V. Van, Yan Wang, Jie Shen, Bryant Lau, Vladimir W. Spolsky, James J. Crall and Honghu Liu

Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices

This paper describes the rationale and goals of the Patient-Reported Outcome (PRO) Consortium’s instrument translation process. The PRO Consortium has developed a number of novel PRO measures which are in the ...

Authors: Sonya Eremenco, Sheryl Pease, Sarah Mann and Pamela Berry

Patient experience in systemic lupus erythematosus: development of novel patient-reported symptom and patient-reported impact measures

Comprehensive assessment of systemic lupus erythematosus (SLE) and its treatment requires patient-reported outcome (PRO) measures to capture impacts and fluctuating symptoms. The objective of this study was to...

Authors: S. D. Mathias, P. Berry, J. De Vries, K. Pascoe, H. H. Colwell, D. J. Chang and A. D. Askanase

Psychometric evaluation of a caregiver diary for the assessment of symptoms of respiratory syncytial virus

There are no clinical outcome assessment (COA) tools developed in accordance with Food and Drug Administration (FDA) guidance suitable for the evaluation of symptoms associated with respiratory syncytial virus...

Authors: Valerie Williams, Carla DeMuro, Sandy Lewis, Nicole Williams, Todd Wolynn, Paul Wisman, Stan L. Block, Shelly Senders, Seth Toback and Jason W. Chien

Development of a novel observer-reported outcome measure for the assessment of Respiratory Syncytial Virus (RSV) infection symptoms in pediatric clinical trials

Respiratory syncytial virus (RSV) is a seasonal infection affecting most children by 2 years of age and the leading cause of lower respiratory tract infection requiring hospitalization in infants. Novel antivi...

Authors: Sandy Lewis, Carla DeMuro, Stan L. Block, Shelly Senders, Paul Wisman, Seth Toback, Jason W. Chien and Valerie Williams

Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures

This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) under...

Authors: Catherine Acquadro, Donald L. Patrick, Sonya Eremenco, Mona L. Martin, Dagmara Kuliś, Helena Correia and Katrin Conway

Development and psychometric validation of the Nausea/Vomiting Symptom Assessment patient-reported outcome (PRO) instrument for adults with secondary hyperparathyroidism

We developed the Nausea/Vomiting Symptom Assessment (NVSA^©) patient-reported outcome (PRO) instrument to capture patients’ experience with nausea and vomiting while on calcimimetic therapy to treat secondary hype...

Authors: Colleen A. McHorney, Mark E. Bensink, Laurie B. Burke, Vasily Belozeroff and Chad Gwaltney