The BODY-Q Cellulite Scale: A Development and Validation Study

2020 ◽  
Author(s):  
Anne F Klassen ◽  
Manraj N Kaur ◽  
Claire E E de Vries ◽  
Lotte Poulsen ◽  
Trisia Breitkopf ◽  
...  
Keyword(s):  
Field Test ◽  
Subcutaneous Tissue ◽  
Measurement Theory ◽  
Qualitative Interviews ◽  
Test Sample ◽  
Patient Reported Outcome ◽  
The Body ◽  
Patient Interviews ◽  
Patient Reported ◽  
The Impact

Abstract Background Cellulite is a localized metabolic disorder of the subcutaneous tissue. To measure the impact of cellulite and its treatment(s) on patients’ health-related quality of life, a psychometrically sound patient-reported outcome measure is needed. Objectives The authors sought to develop and field test a new BODY-Q cellulite scale to measure the appearance of cellulite. Methods Appearance-related codes from the original BODY-Q qualitative interviews were reexamined, and a set of cellulite-specific items was developed and refined through cognitive patient interviews (n = 10) and expert input (n = 17). This scale was field-tested in adults with cellulite through 2 crowdworking platforms. Rasch Measurement Theory analysis was employed to refine the scale and examine its psychometric properties. Results The field-test sample included 2129 participants. The 15-item scale was reduced in length to 11 items. Data from the sample fit the Rasch model (X2 [99] = 21.32, P = 0.06). All items had ordered thresholds and mapped out a targeted clinical hierarchy. The reliability statistics for the person separation index was 0.94 and for Cronbach’s alpha was 0.97. In terms of validity, worse scores on the cellulite scale were associated with being more bothered by how the cellulite looked overall, having more severe cellulite on the Patient-Reported Photo-numeric Cellulite Severity Scale, and having more self-reported cellulite and more areas of the body with cellulite. Conclusions The BODY-Q cellulite scale can be utilized to measure appearance of cellulite and provides a solid basis for future studies evaluating the impact of cellulite and its treatment.

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

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Louise H. Strickland ◽  
David W. Murray ◽  
Hemant G. Pandit ◽  
Crispin Jenkinson
Keyword(s):  
Knee Replacement ◽  
Healthcare Professionals ◽  
Outcome Measure ◽  
Qualitative Interviews ◽  
Patient Reported Outcome ◽  
Early Recovery ◽  
Patient Reported Outcome Measure ◽  
Patient Interviews ◽  
Patient Reported ◽  
Change Measure

Abstract Background 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 recovery in this growing patient population. The process of development and psychometric evaluation of the Oxford Arthroplasty Early Recovery Score (OARS), a 14-item patient-reported outcome measure (PROM) measuring health status, and the Oxford Arthroplasty Early Change Score (OACS) a 14-item measure to assess change during the first 6 weeks following surgery is reported. Patients and methods A five-phased, best practice, iterative approach was used. From a literature based starting point, qualitative interviews with orthopaedic healthcare professionals, were then performed ascertaining if and how clinicians would use such a PROM and change measure. Analysis of in-depth patient-interviews in phase one identified important patient-reported factors in early recovery which were used to provide questionnaire themes. In Phase two, candidate items from Phase One interviews were generated and pilot questionnaires developed and tested. Exploratory factor analysis with item reduction and final testing of the questionnaires was performed in phase three. Phase Four involved validation testing. Results Qualitative interviews (n = 22) with orthopaedic healthcare professionals, helped determine views of potential users, and guide structure. In Phase One, factors from patient interviews (n = 30) were used to find questionnaire themes and generate items. Pilot questionnaires were developed and tested in Phase Two. Items were refined in the context of cognitive debrief interviews (n = 34) for potential inclusion in the final tools. Final testing of questionnaire properties with item reduction (n = 168) was carried out in phase three. Validation of the OARS and OACS was performed in phase four. Both measures were administered to consecutive patients (n = 155) in an independent cohort. Validity and reliability were assessed. Psychometric testing showed positive results, in terms of internal consistency and sensitivity to change, content validity and relevance to patients and clinicians. In addition, these measures have been found to be acceptable to patients throughout early recovery with validation across the 6 week period. Conclusions These brief, easy-to-use tools could be of great use in assessing recovery pathways and interventions in arthroplasty surgery.

The development of patient-reported outcome indices for multiple sclerosis (PRIMUS)

2009 ◽  
Vol 15 (9) ◽  
pp. 1092-1102 ◽  
Author(s):  
LC Doward ◽  
SP McKenna ◽  
DM Meads ◽  
J Twiss ◽  
BJ Eckert
Keyword(s):  
Multiple Sclerosis ◽  
Qualitative Interviews ◽  
Nottingham Health Profile ◽  
Patient Reported Outcome ◽  
Postal Survey ◽  
Cognitive Debriefing ◽  
Scaling Properties ◽  
Patient’S Perspective ◽  
Patient Reported ◽  
The Impact

Background Complex diseases such as multiple sclerosis (MS) present dilemmas over the choice of patient-reported outcome measures as no single scale can inform on all types of MS impact from the patient’s perspective. Objective To develop an outcome tool, the Patient-Reported Indices for Multiple Sclerosis (PRIMUS), to assess MS symptoms, activities, and quality of life. Methods PRIMUS content was derived from qualitative interviews with UK MS patients and checked by clinical experts. Semi-structured cognitive debriefing interviews assessed scale face and content validity. PRIMUS scaling properties, reliability, and construct validity were assessed by a test–retest postal survey. Results Cognitive debriefing interviews ( n = 15) demonstrated scale clarity, relevance, and comprehensiveness. The postal survey was completed by 135 patients with MS. After removal of misfitting items and those exhibiting differential item functioning, all scales fitted the Rasch model, confirming unidimensionality. For all scales, test–retest reliability exceeded 0.80. Scale scores were related to perceived MS severity, general health, and symptoms of depression. Moderate correlations were observed between PRIMUS and Nottingham Health Profile scores. Conclusions Clinicians and researchers can have confidence in scores obtained by respondents on the PRIMUS. The PRIMUS will aid the assessment of the impact of MS from the patient’s perspective.

scholarly journals The BODY-Q Chest Module: Further Validation in a Canadian Chest Masculinization Surgery Sample

2020 ◽  
Author(s):  
Anne F Klassen ◽  
Giancarlo McEvenue ◽  
Yi Wang ◽  
Charlene Rae ◽  
Manraj Kaur ◽  
...  
Keyword(s):  
Measurement Theory ◽  
Patient Reported Outcome ◽  
The Body ◽  
Chi Square ◽  
Response Options ◽  
Item Fit ◽  
Patient Reported ◽  
Patient Health ◽  
Related Quality ◽  
Health Related

Abstract Background The BODY-Q Chest module is a patient-reported outcome (PRO) instrument that measures satisfaction with how the chest (10 items) and nipples (5 items) look. This PRO instrument was previously field tested in an international sample of people seeking treatment for gynecomastia (n = 174), weight loss (n = 224), and chest masculinization (n = 341). Objectives The aim of this study was to examine the psychometric performance of the BODY-Q Chest module in a new chest masculinization surgery sample. Methods Data were collected from patients attending a private plastic surgery outpatient clinic in Canada between January 2018 and June 2019. Rasch measurement theory analysis was used to examine how the scales performed psychometrically. Results The sample provided 266 assessments (115 preoperative, 151 postoperative). All items had ordered thresholds, providing evidence that the 4 response options for each scale worked as expected. Item fit was within ±2.5 for all items, with all Bonferroni adjusted chi-square values nonsignificant. The data for the chest (χ2(20) = 18.72, P = 0.54) and nipples (χ 2(10) = 12.28, P = 0.27) scales fit the requirements of the Rasch model. Reliability was high with person separation index and Cronbach’s α values of ≥0.95 for the chest and ≥0.87 for the nipple scales, respectively. More depressive symptoms on the Patient Health Questionnaire-9 and lower health-related quality of life scales were weakly correlated with worse scores on the chest and nipple scales (P < 0.001). Conclusions The BODY-Q Chest module was shown to be scientifically sound in an independent sample of patients seeking chest masculinization surgery.

scholarly journals Qualitative interviews to improve patient-reported outcome measures in late-onset Pompe disease: the patient perspective

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Alaa Hamed ◽  
Kristina An Haack ◽  
Chad Gwaltney ◽  
Eileen Baranowski ◽  
Andrew Stewart ◽  
...  
Keyword(s):  
Literature Review ◽  
Conceptual Model ◽  
Pompe Disease ◽  
Patient Perspective ◽  
Late Onset ◽  
Qualitative Interviews ◽  
Patient Reported Outcome ◽  
Patient Interviews ◽  
Patient Interview ◽  
Patient Reported

Abstract Background Late-onset Pompe Disease (LOPD) is a rare, heterogeneous disease manifested by a range of symptoms varying in severity. Research establishing the frequency of these symptoms and their impact on patients’ daily lives is limited. The objective of this study was to develop a conceptual model that captures the most relevant symptoms and functional limitations experienced by patients with LOPD, to inform the development of new patient-reported outcome (PRO) tools. Methods A preliminary conceptual model was constructed following a literature review and revised through interviews with expert clinicians to identify important and relevant concepts regarding symptoms and impacts of LOPD. This preliminary model informed the development of a qualitative patient interview guide, which was used to gather the patient perspective on symptoms and impacts relating to LOPD or its treatment (including symptom/impact frequency and levels of disturbance). Patient interviews aided further refinement of the conceptual model. The findings from the patient interviews were triangulated with the literature review and clinician interviews to identify the most relevant and significant effects of LOPD from the patient perspective. Results Muscle weakness, fatigue, pain, and breathing difficulties (especially while lying down) were the most common and highly disturbing symptoms experienced by patients. Limitations associated with mobility (e.g., difficulty rising from a sitting position, getting up after bending) and activities of daily living, (e.g., reduced ability to participate in social/family activities or work/study) were the most frequently reported impacts with the highest levels of disturbance on the patient’s daily life. These identified symptoms and impacts were included in the new conceptual model of disease. Conclusions This qualitative patient interview study, also informed by a literature review and clinician interviews, identified the most frequent and relevant symptoms and the functional impact of LOPD on patients. The study interviews also captured the patient-preferred language to describe symptoms and impacts of LOPD. The results from this study can be used to develop future PRO instruments that are tailored to the specific symptoms and impacts experienced by patients with LOPD.

scholarly journals Conducting Patient Interviews Within a Clinical Trial Setting

2018 ◽  
Author(s):  
Dana B. DiBenedetti ◽  
T. Michelle Brown ◽  
Carla Romano ◽  
Claire Ervin ◽  
Sandy Lewis ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Qualitative Interviews ◽  
Patient Reported Outcome ◽  
Treatment Needs ◽  
Clinical Trial Setting ◽  
Patient Interviews ◽  
Treatment Gaps ◽  
Patient Reported ◽  
Trial Participants ◽  
Trial Setting

Qualitative data centered on patients’ experiences and perspectives typically go uncollected in clinical trial settings. Yet patients’ treatment experiences offer complementary insights and context on topics such as disease management, treatment gaps, and previous treatments outside of those gathered in traditional patient-reported outcome questionnaires. Qualitative interviews can capture patients’ perceptions of treatment needs, more fully explore meaningful changes experienced as a result of treatment, and reveal outcomes that are most important to patients. Asking patients detailed questions can provide insight into the “why” of a patient’s expressed thought or feeling. The inclusion of patient interviews within clinical trials is a relatively new and evolving field of research. This article delineates the types of data that may be collected during interviews with clinical trial participants and outlines two approaches to conducting qualitative research in the clinical trial setting, with a focus on maximizing the value of the resulting data.

scholarly journals International mixed methods study protocol to develop a patient-reported outcome measure for all types of chronic wounds (the WOUND-Q)

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e032332 ◽  
Author(s):  
Anne Klassen ◽  
Emiel LWG van Haren ◽  
Karen Cross ◽  
Kenneth L Fan ◽  
Chris Gibbons ◽  
...  
Keyword(s):  
The Netherlands ◽  
Conceptual Framework ◽  
Chronic Wounds ◽  
Wound Care ◽  
Measurement Theory ◽  
Reliability And Validity ◽  
Patient Reported Outcome ◽  
The Body ◽  
Patient Reported ◽  
The Usa

IntroductionMost patient-reported outcome measures (PROM) for chronic wounds are specific to a single wound type (eg, pressure ulcer) or part of the body. A barrier to outcome assessment in wound care and research is the lack of a rigorously designed PROM that can be used across wound types and locations. This mixed method study describes the protocol for an international collaboration to develop and validate a new PROM called the WOUND-Q for adults with chronic wounds.Methods and analysisIn phase I, the qualitative approach of interpretive description is used to elicit concepts important to people with wounds regarding outcome. Participants from Canada, Denmark, the Netherlands, and the USA are aged 18 years and older and have a wound that has lasted 3 months or longer. Interviews are digitally recorded, transcribed and coded. A conceptual framework and preliminary item pool are developed from the qualitative dataset. Draft scales are formed to cover important themes in the conceptual framework. These scales are refined using feedback from people with chronic wounds and wound care experts. After refinement, the scales are translated into Danish and Dutch, following rigorous methods, to prepare for an international field-test study. In phase II, data are collected in Canada, Denmark, the Netherlands, and the USA. An international sample of people with a large variety of chronic wounds complete the WOUND-Q. Rasch Measurement Theory analysis is used to identify the best subset of items to retain for each scale and to examine reliability and validity.Ethics and disseminationThis study is coordinated at Brigham and Women’s Hospital (Boston, USA). Ethics board approval was received at each participating site for both study phases. Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.

Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study

2020 ◽  
Vol 9 (17) ◽  
pp. 1195-1204
Author(s):  
Florence D Mowlem ◽  
Brad Sanderson ◽  
Jill V Platko ◽  
Bill Byrom
Keyword(s):  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Structured Interviews ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Anticancer Treatment ◽  
Fit For Purpose ◽  
The Impact ◽  
Electronic Implementation

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

scholarly journals Understanding the patient experience in hepatocellular carcinoma: a qualitative patient interview study

2021 ◽  
Author(s):  
Nikunj Patel ◽  
Joshua Maher ◽  
Xandra Lie ◽  
Chad Gwaltney ◽  
Afsaneh Barzi ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Drug Development ◽  
Conceptual Model ◽  
Patient Experience ◽  
Outcome Measurement ◽  
Qualitative Interviews ◽  
Patient Reported Outcome ◽  
Weight Changes ◽  
Patient Reported ◽  
Pro Instruments

Abstract Purpose This study aimed to elucidate the patient experience of hepatocellular carcinoma (HCC) to guide patient-centered outcome measurement in drug development. Methods Patients with HCC participated in qualitative interviews to elicit disease-related signs/symptoms and impacts, using discussion guides developed from literature searches and discussions with oncologists. Interview participants rated the disturbance of their experiences (0–10 scale). A conceptual model was developed and mapped against patient-reported outcome (PRO) instruments identified from database reviews. Results Interviews were conducted with 25 individuals with HCC (68% were men; median age: 63 years; 12% Barcelona clinic liver cancer (BCLC) stage A; 32% stage B; and 56% stage C) in the USA. Fifty-one HCC-related concepts were identified from the interviews and were grouped into eight sign/symptom categories (eating behavior/weight changes; extremities [arms, legs]; fatigue and strength; gastrointestinal; pain; sensory; skin; other) and four impact categories (emotional; physical; cognitive function; other) for the conceptual model. The most prevalent and disturbing experiences across the disease stages were fatigue/lack of energy and emotional impacts such as frustration, fear, and depression. Abdominal pain and skin-related issues were particularly common and disturbing in individuals with HCC stage C. The EORTC QLQ-C30 and HCC18 were identified as commonly used PRO instruments in HCC studies and captured the relevant signs/symptoms associated with the patient experience. Conclusion Patients with HCC reported a range of signs/symptoms and impacts that negatively affect daily functioning and quality of life. Including PRO measures in HCC clinical trials can provide meaningful patient perspectives during drug development.

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

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Ryan Lange ◽  
Abigail Kumagai ◽  
Sara Weiss ◽  
Katherine B. Zaffke ◽  
Sherry Day ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Contrast Sensitivity ◽  
Qualitative Interviews ◽  
Well Being ◽  
Vision Impairment ◽  
Qualitative Interview Study ◽  
Patient Reported ◽  
Related Quality ◽  
The Impact

Abstract Background 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 peripheral field loss (PFL). Measurement of VR-QOL in severe PFL is important in order to determine the effectiveness of vision rehabilitation interventions for this population. The purpose of this study was to characterize the impact of severe PFL due to retinitis pigmentosa (RP) and glaucoma on VR-QOL as the initial phase in the development of a novel PRO measure. Methods Individuals with severe PFL due to RP or glaucoma were recruited from the Kellogg Eye Center and the Association for the Blind and Visually Impaired. Participants completed semi-structured qualitative interviews, the Impact of Vision Impairment (IVI) questionnaire and the RAND 36-Item Health Survey. Interviews were analyzed by two coders using thematic analysis. A matrix analysis was conducted to compare VR-QOL by cause of severe PFL. Sample size was determined by thematic saturation. Results The study included 37 participants (19 RP, 18 glaucoma). Median best-corrected visual acuity for those with RP and glaucoma was 20/40 and 20/27.5, while Pelli-Robson contrast sensitivity was 1.2 log contrast sensitivity (logCS) and 1.1 logCS, respectively. Median domain scores on the IVI (reading, mobility, well-being) ranged from a low of − 0.2 to a high of 0.7 logits in those with RP and from 0.5 to 1.2 logits in those with glaucoma. Qualitative interviews identified six VR-QOL themes relevant across participants with both RP and glaucoma, including activity limitations, driving, emotional well-being, reading, mobility, and social function. VR-QOL concerns were largely consistent among those with severe PFL due to RP and glaucoma. These overarching themes contained content relevant to specific challenges related to severe PFL. Conclusions There are commonly occurring VR-QOL concerns among individuals with severe PFL due to RP and glaucoma. The outlined themes will serve as the basis for development of the Low Vision Severely Constricted Peripheral Eyesight (LV-SCOPE) Questionnaire.

Suicide Loss Survivors: Navigating Social Stigma and Threats to Social Bonds

2021 ◽  
pp. 003022282110265
Author(s):  
Dorothy M. Goulah-Pabst
Keyword(s):  
Social Stigma ◽  
Qualitative Interviews ◽  
Healing Process ◽  
Personal Narratives ◽  
The Body ◽  
Social Solidarity ◽  
Sociological Study ◽  
Social Challenges ◽  
The Social ◽  
The Impact

The complicated grief experienced by suicide loss survivors leads to feelings of abandonment, rejection, intense self-blame, and depression. Stigma surrounding suicide further burdens survivors who can experience rejection by their community and social networks. Research in the field of psychology has delved into the grieving process of suicide loss survivors, however the effects of suicide require more sociological study to fully understand and support the impact of the suicidal bereavement process on the social interactions and relationships of those left behind after death. This study aims to contribute to the body of research exploring the social challenges faced after the suicide of a loved one. Based on the analysis of powerful personal narratives through qualitative interviews shared by 14 suicide loss survivors this study explores the social construction of the grieving and healing process for suicide loss survivors. Recognizing that the most reliable relief is in commiseration with like experienced people, this research points to the support group as a builder of social solidarity. The alienation caused by the shame and stigma of suicide loss can be reversed by the feelings of attachment to the group that listens, understands and accepts. Groups created by and for suicide loss survivors should be considered a necessary tool to be used toward healing those who suffer from loss by suicide.

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