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Article: Development and Content Validation of Novel Patient-Reported Outcome Measures to Assess Disease Severity and Change in Patients with Erythropoietic Protoporphyria: The EPP Impact Questionnaire (EPIQ).

Mathias, Susan D / Burke, Laurie / Colwell, Hilary H / Mensing, George / Savage, Will / Naik, Hetanshi

2024 Volume 15, Page(s) 17–30

Abstract: Purpose: Erythropoietic protoporphyria (EPP), a rare inherited disorder, presents in early childhood with severe, painful phototoxicity, with significant impacts on health-related quality of life (HRQoL). Previous studies have not captured all concepts ... ...

Abstract	Purpose: Erythropoietic protoporphyria (EPP), a rare inherited disorder, presents in early childhood with severe, painful phototoxicity, with significant impacts on health-related quality of life (HRQoL). Previous studies have not captured all concepts important to patients. Therefore, this study sought to develop a novel, comprehensive, and content valid patient-reported outcome (PRO) measure to assess the efficacy of new therapies. Patients and methods: Qualitative interviews were conducted with EPP participants and clinical experts to obtain views on concepts relevant to patients. Results informed the development of novel PROs, which were debriefed during subsequent combined concept elicitation and cognitive debriefing interviews. Results: Twenty-three interviews were conducted with 17 adults and 6 adolescents with EPP. Concept elicitation revealed that participants experienced many symptoms with significant variability. The most common were burning, pain, swelling, and tingling. Tingling was the most common prodromal symptom, while burning was the most bothersome, and pain was the worst full reaction symptom. Participants reported being negatively impacted in their ability to do daily activities, and social and emotional functioning. Many reported impacted ability to work and be productive at their job. Participants reviewed and completed the newly developed PRO measures assessing full reactions and ability to do activities, as well as items to assess severity and change in severity of prodromal symptoms, full reactions, and EPP overall. All measures were found to be comprehensive, clear, and relevant. Conclusion: PRO measures are needed to assess important aspects of HRQoL and evaluate therapeutic response. These PRO measures are unique in assessing overall severity and change in EPP.
Language	English
Publishing date	2024-02-14
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2586660-6
ISSN	1179-271X
ISSN	1179-271X
DOI	10.2147/PROM.S438892
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Article ; Online: Patient-Centered Core Impacts Sets (PC-CIS): What They Are and What They Are Not.

Perfetto, Eleanor M / Schrandt, Suz / Escontrías, Omar A / Burke, Laurie B

Innovations in pharmacy

2023 Volume 14, Issue 1

Abstract: Letter to the Editor We are writing regarding the Innovations in Pharmacy commentary entitled, "Evidentiary Standards for Patient-Centered Core Impact Value Claims."(1) We thank Dr. Langley for commenting on the National Health Council's work on patient- ... ...

Abstract	Letter to the Editor We are writing regarding the Innovations in Pharmacy commentary entitled, "Evidentiary Standards for Patient-Centered Core Impact Value Claims."(1) We thank Dr. Langley for commenting on the National Health Council's work on patient-centered core impact sets (PC-CIS), an initiative spearheaded by the nonprofit organization and its membership with multi-stakeholder representation and input.(2-4) While we have tried to be clear and transparent about the intent of PC-CIS, the commentary made it apparent to us we need to (and will) do more to be explicit about what a PC-CIS is and is not, and its possible downstream uses. We believe the PC-CIS concept was misrepresented in the commentary and want to provide clarification for readers so they can consider the merits of the initiative for themselves.
Language	English
Publishing date	2023-10-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	2689516-X
ISSN	2155-0417 ; 2155-0417
ISSN (online)	2155-0417
ISSN	2155-0417
DOI	10.24926/iip.v14i1.5264
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Article: Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax): Evaluation of Measurement Performance.

Hobart, Jeremy / Burke, Laurie / Kirsch, Brandon / Chadha, Deepak

Journal of drugs in dermatology : JDD

2021 Volume 20, Issue 4, Page(s) 410–418

Abstract: Background: Clinical trials of primary axillary hyperhidrosis (AHH) require rigorous measurement of AHH severity from the patient’s perspective. Previously, we reported conceptualization and item content development for the Hyperhidrosis Disease ... ...

Abstract	Background: Clinical trials of primary axillary hyperhidrosis (AHH) require rigorous measurement of AHH severity from the patient’s perspective. Previously, we reported conceptualization and item content development for the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale. Objective: To evaluate the psychometric performance and estimate clinically meaningful change scores for the HDSM-Ax in a Phase IIb clinical study of sofpironium bromide gel for AHH. Method: HDSM-Ax measurement performance was analyzed in trial response data using two psychometric paradigms: Classical Test and Rasch Measurement Theories (CTT; RMT). HDSM-Ax meaningful change scores were estimated from anchor-based methods using two global summary questions of hyperhidrosis severity and the Hyperhidrosis Disease Severity Score (HDSS). Results: HDSM-Ax satisfied CTT and RMT criteria as a fit-for-purpose outcome measure in AHH clinical trials. Within-person anchor-based analyses indicated a 1-point change in HDSM-Ax severity score (range, 0–4) represents a clinically meaningful change in AHH severity. Conclusion: HDSM-Ax is a well-defined and reliable measure of AHH severity. A 1-point change in HDSM-Ax score is clinically meaningful. J Drugs Dermatol.20(4):410-418. doi:10.36849/JDD.5569.
MeSH term(s)	Administration, Cutaneous ; Adult ; Axilla ; Cholinergic Antagonists/administration & dosage ; Cholinergic Antagonists/adverse effects ; Clinical Trials, Phase II as Topic ; Female ; Gels ; Humans ; Hyperhidrosis/drug therapy ; Hyperhidrosis/psychology ; Male ; Middle Aged ; Multicenter Studies as Topic ; Psychometrics/methods ; Quality of Life ; Randomized Controlled Trials as Topic ; Reproducibility of Results ; Severity of Illness Index ; Treatment Outcome ; Young Adult
Chemical Substances	Cholinergic Antagonists ; Gels
Language	English
Publishing date	2021-04-23
Publishing country	United States
Document type	Evaluation Study ; Journal Article
ZDB-ID	2145090-0
ISSN	1545-9616
ISSN	1545-9616
DOI	10.36849/JDD.2021.5569
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Article ; Online: Development and content validation of a sunlight exposure diary in patients with erythropoietic protoporphyria.

Mathias, Susan D / Burke, Laurie / Colwell, Hilary H / Mensing, George / Savage, Will / Naik, Hetanshi

Journal of patient-reported outcomes

2023 Volume 7, Issue 1, Page(s) 119

Abstract: Background: Erythropoietic protoporphyria is a rare, inherited disorder presenting in early childhood with severe, painful phototoxicity. EPP has significant impacts on health-related quality of life, though there is variable disease severity. ... ...

Abstract	Background: Erythropoietic protoporphyria is a rare, inherited disorder presenting in early childhood with severe, painful phototoxicity. EPP has significant impacts on health-related quality of life, though there is variable disease severity. Accurately capturing how much time individuals with EPP can spend outdoors before they develop symptoms is critical to understanding HRQoL and measuring therapeutic response. Therefore, the goal of this study was to develop a comprehensive and content valid sun exposure diary to assess the efficacy of new therapies in individuals with EPP. Methods: Qualitative interviews were conducted with adult and adolescent EPP participants, as well as five clinical experts, to obtain their input on the content of an existing sun exposure diary. Revisions to the diary were made based on evidence generated in cognitive debriefing interviews analyzed in eight consecutive groups of EPP participant. Results: Interviews were conducted with 17 adults and 6 adolescents with EPP. The average age of adults was 40 years and of adolescents was 14 years. Clinical experts thought the original diary needed clarification on the description of symptoms, how time outdoors was captured, and the distinction between direct vs. indirect sunlight. Participants with EPP also noted these items needed revision, and that the distinction between prodromal symptoms and full reaction symptoms should be clarified. In the final diary version, participants with EPP found most items to be clear and easy to complete/think about. Seventy-six percent of participants (13/17) asked thought the diary was easy to complete. The remainder thought the majority of the diary was easy to complete with the exception of select questions. Conclusions: Evaluating a new treatment for EPP requires accurately capturing time in sunlight and symptoms in this unique disorder. The newly developed sun exposure diary is content valid and can be used to assess important aspects of symptoms and daily life and therefore evaluate clinically meaningful therapeutic response.
MeSH term(s)	Child, Preschool ; Adolescent ; Adult ; Humans ; Protoporphyria, Erythropoietic/diagnosis ; Quality of Life ; Sunlight/adverse effects ; Patients ; Dermatitis, Phototoxic ; Rare Diseases
Language	English
Publishing date	2023-11-20
Publishing country	Germany
Document type	Journal Article
ISSN	2509-8020
ISSN (online)	2509-8020
DOI	10.1186/s41687-023-00655-y
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Article ; Online: Measuring upper limb function in MS: Which existing patient reported outcomes are fit for purpose?

Close, James / Baines, Kathryn / Burke, Laurie / Hobart, Jeremy

eNeurologicalSci

2020 Volume 19, Page(s) 100237

Abstract: Background: Multiple Sclerosis (MS) clinical trials increasingly focus on progressive and advanced MS, with upper limb function (ULF) as a key outcome. Within clinical trials, Patient Reported Outcomes (PROs) quantify clinical variables and establish ... ...

Abstract	Background: Multiple Sclerosis (MS) clinical trials increasingly focus on progressive and advanced MS, with upper limb function (ULF) as a key outcome. Within clinical trials, Patient Reported Outcomes (PROs) quantify clinical variables and establish meaningfulness of changes. Scientific standards and regulatory criteria (from Food and Drug Administration [FDA]) require PROs be "fit-for-purpose": well-defined and reliable measures of specific concepts in defined contexts. Objective: To identify, from literature, existing PROs measuring ULF and determine which satisfy scientific and regulatory clinical trials requirements. Method: We screened PubMed/Web of Science using multiple relevant terms. Abstracts and full texts were screened using suitability criteria. PRO development papers were evaluated using recently expanded Consensus Standards for Measurement Instruments (COSMIN) criteria for content development. Results: We identified 3619 articles; 485 used 24 different ULF PROs. No PRO satisfied scientific and regulatory requirements as a well-defined measure of a clearly defined construct in a specific clinical context. Conclusions: Existing ULF PROs don't meet fit-for-purpose criteria. MS clinical trials require new measures with greater emphasis on patient engagement to derive theoretical frameworks, concepts of interest, and contexts of use followed by systematic literature searches, expert input, and qualitative research to support item generation. Until then, trials will miss aspects of meaningful within-patient change and thereby misrepresent (likely underestimating) treatment effects.
Language	English
Publishing date	2020-03-16
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	2838045-9
ISSN	2405-6502 ; 2405-6502
ISSN (online)	2405-6502
ISSN	2405-6502
DOI	10.1016/j.ensci.2020.100237
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Article ; Online: Measuring Health and Well-Being: We Need to Get it Right for Patients, With Patients.

Perfetto, Eleanor M / Burke, Laurie / Love, T Rosie / Schrandt, M Suz / Hobart, Jeremy

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2022 Volume 26, Issue 3, Page(s) 435–437

MeSH term(s)	Humans ; Patients ; Health Status ; Health Status Indicators
Language	English
Publishing date	2022-11-15
Publishing country	United States
Document type	Letter
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2022.11.005
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Article ; Online: Do clinical trials prepare to fail by failing to prepare? An examination of MS trials and recommendations for patient-reported outcome measure selection.

Hobart, Jeremy / Chitnis, Tanuja / Oh, Jiwon / Burke, Laurie / King, Miriam / Vo, Pamela / Vandercappellen, Jo / Lloyd, Andrew

Multiple sclerosis and related disorders

2023 Volume 76, Page(s) 104788

Abstract: Background: Many clinical trials use patient-reported outcome (PRO) measures, which can influence treatment decision-making, drug approval and label claims. Given that many PRO measure options exist, and there are conceptual and contextual complexities ... ...

Abstract	Background: Many clinical trials use patient-reported outcome (PRO) measures, which can influence treatment decision-making, drug approval and label claims. Given that many PRO measure options exist, and there are conceptual and contextual complexities with PRO measurement, we aimed to evaluate how and why specific PRO measures have been selected for pivotal multiple sclerosis (MS) clinical trials. Specifically, we aimed to identify the reasons documented for PRO measure selection in contemporary phase III MS disease-modifying treatment (DMT) clinical trials. Methods: We searched for phase III clinical trials of MS DMTs published between 2015 and 2021 and evaluated trial protocols, or primary publications where available, for PRO measure selection information. Specifically, we examined study documents for their clarification of clinical concepts measured, definitions of concepts measured, explanations of which PRO measures were considered, why specific PRO measures were chosen, and trade-offs in PRO measure selection. Results: We identified 1705 abstracts containing 61 unique phase III MS DMT clinical trials. We obtained and examined 27/61 trial protocols. Six protocols were excluded: four contained no mention of PRO measures and two contained redacted sections preventing adequate assessment, leaving 21 protocols for assessment. For the remaining 34 trials (61-27), we retrieved 31 primary publications; 15 primary publications mentioned the use of a PRO measure. None of the 36 clinical trials that mentioned the use of PRO measures (21 protocols and 15 primary publications) documented clear PRO or clinical outcome assessment (COA) measurement strategies, provided clear justifications for PRO selection, or reasons why specific PRO measures were selected when alternatives existed. Conclusion: PRO measure selection for clinical trials is not evidence-based or underpinned by structured systematic approaches. This represents a critical area for study design improvement as PRO measure results directly affect patient care, PRO measurement has conceptual and contextual complexities, and there is a wide range of options when selecting a PRO measure. We recommend trial designers use formal approaches for PRO measure selection to ensure PRO measurement-based decisions are optimised. We provide a simple, logical, five-stage approach for PRO measure selection in clinical trials.
MeSH term(s)	Humans ; Multiple Sclerosis/diagnosis ; Multiple Sclerosis/drug therapy ; Patient Reported Outcome Measures ; Research Design
Language	English
Publishing date	2023-06-07
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	2645330-7
ISSN	2211-0356 ; 2211-0348
ISSN (online)	2211-0356
ISSN	2211-0348
DOI	10.1016/j.msard.2023.104788
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Article ; Online: Inventory of Complicated Spiritual Grief 2.0 (ICSG 2.0): Validation of a revised measure of spiritual distress in bereavement.

Burke, Laurie A / Crunk, A Elizabeth / Neimeyer, Robert A / Bai, Haiyan

Death studies

2019 Volume 45, Issue 4, Page(s) 249–265

Abstract: Spirituality has long served as a source of solace for many grievers following a loss. For other mourners, whose bereavement experience has been significantly challenged by struggles in their relationship with God and/or their faith community, the ... ...

Abstract	Spirituality has long served as a source of solace for many grievers following a loss. For other mourners, whose bereavement experience has been significantly challenged by struggles in their relationship with God and/or their faith community, the opposite is true. Complicated spiritual grief (CSG) is a spiritual crisis following the loss of a loved one. To assess CSG in samples of bereaved adults, a simple-to-use, multidimensional measure of spiritual crisis following loss called the Inventory of Complicated Spiritual Grief (ICSG) was previously developed and validated. However, subsequent research providing greater clarity about the construct of CSG supported the need to revise and update the ICSG. The goal of the present study was to establish the psychometric validity of a revised measure of CSG, called the Inventory of Complicated Spiritual Grief 2.0 (ICSG 2.0), with a large, diverse cohort of bereaved Christian adults (
MeSH term(s)	Adult ; Bereavement ; Grief ; Humans ; Motivation ; Spiritual Therapies ; Spirituality
Language	English
Publishing date	2019-06-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	632596-8
ISSN	1091-7683 ; 0748-1187
ISSN (online)	1091-7683
ISSN	0748-1187
DOI	10.1080/07481187.2019.1627031
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Article: Complicated spiritual grief I: relation to complicated grief symptomatology following violent death bereavement.

Burke, Laurie A / Neimeyer, Robert A

Death studies

2014 Volume 38, Issue 1-5, Page(s) 259–267

Abstract: Losing a loved one to violent death has been associated with poor mental health outcomes, including posttraumatic stress disorder, depression, and complicated grief (CG), a protracted, debilitating, and sometimes life-threatening reaction to loss. In ... ...

Abstract	Losing a loved one to violent death has been associated with poor mental health outcomes, including posttraumatic stress disorder, depression, and complicated grief (CG), a protracted, debilitating, and sometimes life-threatening reaction to loss. In addition, recent research suggests that traumatic loss can violate mourners' basic assumptive worldviews, and can precipitate a spiritual crisis following loss, also known as complicated spiritual grief (CSG). The present cross-sectional study investigated these multidimensional outcomes in a diverse sample of 150 grievers. The authors found that (a) violently bereaved individuals reported greater CG and CSG than did individuals bereaved by natural death; (b) CG and CSG were correlated across the larger sample, and yet are theoretically different constructs; and (c) specific cause of death (natural anticipated, natural sudden, homicide, suicide, or fatal accident) differentially predicted levels of CG and CSG. Implications of these findings for a clearer understanding of spiritual coping in the wake of troubling loss are noted, as well as for intervention with mourners struggling with clinical complications.
MeSH term(s)	Adolescent ; Adult ; Aged ; Bereavement ; Cross-Sectional Studies ; Death ; Female ; Grief ; Humans ; Male ; Middle Aged ; Spirituality ; Violence/psychology ; Young Adult
Language	English
Publishing date	2014-01
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632596-8
ISSN	0748-1187
ISSN	0748-1187
DOI	10.1080/07481187.2013.829372
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Article ; Online: Domains of Social Support That Predict Bereavement Distress Following Homicide Loss.

Bottomley, Jamison S / Burke, Laurie A / Neimeyer, Robert A

Omega

2017 Volume 75, Issue 1, Page(s) 3–25

Abstract: Psychological adaptation following homicide loss can prove more challenging for grievers than other types of losses. Although social support can be beneficial in bereavement, research is mixed in terms of identifying whether it serves as a buffer to ... ...

Abstract	Psychological adaptation following homicide loss can prove more challenging for grievers than other types of losses. Although social support can be beneficial in bereavement, research is mixed in terms of identifying whether it serves as a buffer to distress following traumatic loss. In particular, studies have not parsed out specific domains of social support that best predict positive bereavement outcomes. Recruiting a sample of 47 African Americans bereaved by homicide, we examined six types of social support along with the griever's perceived need for or satisfaction with each and analyzed them in relation to depression, anxiety, complicated grief, and posttraumatic stress disorder outcomes. Results of multivariate analyses revealed that the griever's level of satisfaction with physical assistance at the initial assessment best predicted lower levels of depression, anxiety, and posttraumatic stress disorder levels 6 months later, while less need for physical assistance predicted lower complicated grief at follow-up. Clinical implications and suggestions for future research are discussed.
MeSH term(s)	Adolescent ; Adult ; Aged ; Bereavement ; Female ; Homicide/psychology ; Humans ; Male ; Middle Aged ; Models, Psychological ; Social Support ; Stress Disorders, Post-Traumatic ; Stress, Psychological ; Young Adult
Language	English
Publishing date	2017-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	207363-8
ISSN	1541-3764 ; 0030-2228
ISSN (online)	1541-3764
ISSN	0030-2228
DOI	10.1177/0030222815612282
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