scholarly journals Development, psychometric evaluation and cognitive debriefing of the rheumatoid arthritis symptom and impact questionnaire (RASIQ)

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Brandon Becker ◽  
Marguerite Bracher ◽  
Deven Chauhan ◽  
Regina Rendas-Baum ◽  
Xiaochen Lin ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Reliability And Validity ◽  
Psychometric Evaluation ◽  
Chronic Inflammatory Disease ◽  
Recall Period ◽  
Cognitive Debriefing ◽  
Two Phase ◽  
Concept Elicitation ◽  
Patient Reported ◽  
Arthritis Symptom

Abstract Background Rheumatoid arthritis (RA) is a chronic inflammatory disease often associated with persistent pain. There is a need for a patient-reported outcome measure (PROM) that is rooted in the patient experience and psychometrically validated. We describe the development of the Rheumatoid Arthritis Symptom and Impact Questionnaire (RASIQ), a novel PROM with potential to record key symptoms and impacts of RA with a 24-h recall period. Results A literature review identified RA concepts that patients considered most important to their disease experience, including pain, fatigue, joint swelling and stiffness. From this, an initial item pool (33 items; 27 related to symptoms, 6 related to impacts) was developed with a recall period of 24 h. Two rheumatologists evaluated each item’s relevance, and the second version of the RASIQ was refined (29 items; 21 related to symptoms, 8 related to impacts). Next, three rounds of cognitive debriefing interviews were conducted with patients with RA (n = 15 overall). The RASIQ was revised to remove items deemed irrelevant or redundant, leaving 16 items measuring symptoms (joint pain, energy/tiredness, joint stiffness) and impacts (rest, sleep). A parallel series of semi-structured concept elicitation interviews (n = 30) facilitated the design of a conceptual model of RA symptoms, impacts and treatment experiences. Post-hoc comparison of the model with RASIQ revealed that all items selected were among the most important and relevant symptoms and impacts for patients. A final round of cognitive debriefing interviews (n = 12) confirmed that the final 16-item RASIQ was relevant and easy to understand, with no further changes recommended. Psychometric evaluation using data from two Phase II RA clinical trials confirmed a 3-factor structure, as well as the reliability and validity of the scale scores, and the ability of RASIQ to detect changes in symptoms and impacts when administered at specific study timepoints, using a 24-h recall period. Conclusions RASIQ is a novel, 16-item PROM developed with substantial patient input. Results from concept elicitation, cognitive debriefing, and psychometric evaluation confirmed the validity of the instrument, which has the potential to measure symptoms and impacts through a 24-h recall period and complement existing disease activity instruments with longer recall periods.

AL Amyloidosis: Development Of a Conceptual Model and a Symptom Diary

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5609-5609
Author(s):  
Emuella Flood ◽  
David Seldin ◽  
Ai-Min Hui ◽  
Deborah Berg ◽  
Huamao Mark Lin
Keyword(s):  
Conceptual Model ◽  
Research Funding ◽  
Al Amyloidosis ◽  
Cell Transplant ◽  
Cognitive Debriefing ◽  
Concept Elicitation ◽  
Wide Range ◽  
Patient Reported ◽  
Symptom Diary ◽  
Patients Perspective

Abstract Introduction Amyloidosis is a very rare blood disease characterized by the production of abnormal misfolded extracellular proteins that are deposited in body tissues or organs, leading to organ dysfunction. The most common form is systemic light chain (AL) amyloidosis. With no cure, treatment is directed at suppressing development of the abnormal protein, correcting or stabilizing organ function, and managing symptoms. Very little research has been done to assess patients’ symptoms in this disease and how they may be mitigated by available therapies.  The first objective of this study was to understand the symptoms and impact of the disease and treatment from the patients’ perspective. This insight was used to develop a comprehensive conceptual model of AL amyloidosis.  A second objective was to confirm the content of a draft amyloidosis symptom diary and provide recommendations to refine the measure. Methods Three data sources were included in this study: 1) A literature review using OvidSP (includes MEDLINE and Embase)using disease-specific and quality of life search terms; 2) An internet search to identify blogs (online diaries) written by patients about their disease/treatment experience; and 3) One-on-one telephone interviews with adult AL amyloidosis patients. Patients were recruited through physician referral and by the Amyloidosis Foundation. Eligible and interested patients were mailed an informed consent form and study questionnaires. Using a standardized guide, a trained interviewer conducted a concept elicitation interview to explore experiences of living with AL amyloidosis, after which the patient completed the symptom diary and underwent a cognitive debriefing interview.  The cognitive debriefing was designed to explore patient understanding of each instruction, item, and response option. Interview transcripts were coded to identify key concepts and themes emerging from the data using qualitative data analysis software, MaxQDA. Results Of 270 English language abstracts identified and reviewed, 10 articles appeared to include a patient-reported outcome (PRO) measure and were selected for full review. Nine patient blogs were identified and reviewed. Symptoms identified from the literature and from patient blogs informed the development of a draft symptom measure. Ten patients participated in the concept elicitation / cognitive debriefing interviews (mean age, 61 years, SD=8; 70% male). Eight reported experience with chemotherapy, 6 reported having received a stem cell transplant, and one had received a heart transplant. Patients identified symptoms as being related to both the disease and/or treatments.  Symptoms reported by at least 30% of the sample included fatigue (100%), weakness (100%), shortness of breath (90%), neuropathy (90%), edema (100%), dizziness/lightheadedness (80%), decreased/lack of appetite (60%), diarrhea (50%), constipation (40%), and difficulty sleeping (30%). Ninety-four percent of codes had been applied by the 7th interview, and only one new code (“heartburn”) was applied in the last interview, suggesting that key symptom concepts were identified with this sample. A conceptual model illustrating the various impacts of disease and treatment was developed.  Findings from cognitive debriefing interviews revealed that overall, patients found the diary to be straightforward and easy to complete. Most patients reported that the symptoms included in the measure adequately captured their experiences with AL amyloidosis. However, feedback suggested that certain symptoms such as swelling in the upper body, needed clarification. Conclusions A comprehensive conceptual model of symptoms and impacts of disease and treatment was developed and could be used to identify important outcomes from the patients’ perspective that should be assessed in clinical trials to capture treatment benefit.  AL amyloidosis is associated with a wide range of symptoms related to location of amyloid deposits, as well as side effects related to the treatment administered.  Despite this variability, a core set of symptoms emerged and a draft diary capturing symptoms likely to be applicable to most patients was developed. Based on the feedback from the cognitive debriefing interviews, patients found the diary to be straightforward and easy to complete.  Additional research and use in trials can provide further evidence for the validity and reliability of the diary. Disclosures: Seldin: Celgene: Research Funding; Prothena: Research Funding; Amyloidosis Foundation: Membership on an entity’s Board of Directors or advisory committees. Hui:Millennium: The Takeda Oncology Company: Employment. Berg:Millennium: The Takeda Oncology Company: Employment. Lin:Millennium: The Takeda Oncology Company: Employment.

Psychometric evaluation of the Rheumatoid Arthritis Symptom Questionnaire (RASQ) in an observational study

2017 ◽  
Vol 33 (12) ◽  
pp. 2121-2128 ◽  
Author(s):  
Benjamin Banderas ◽  
Martha Skup ◽  
Alan L. Shields ◽  
Jonathan Stokes ◽  
Catherine Foley ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Observational Study ◽  
Psychometric Evaluation ◽  
Symptom Questionnaire ◽  
Arthritis Symptom

scholarly journals The Treatment-induced Neuropathy Assessment Scale (TNAS): a psychometric update following qualitative enrichment

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Tito R. Mendoza ◽  
Loretta A. Williams ◽  
Qiuling Shi ◽  
Xin Shelley Wang ◽  
Oluwatosin Bamidele ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Gynecological Cancer ◽  
Qualitative Interviews ◽  
Correlation Coefficients ◽  
Psychometric Evaluation ◽  
Assessment Scale ◽  
Cognitive Debriefing ◽  
Good Reliability ◽  
European Organization ◽  
Patient Reported

Abstract Background The validation of the Treatment-induced Neuropathy Assessment Scale (TNAS v2.0), a patient-reported outcome measure of symptoms associated with cancer treatment-induced peripheral neuropathy (TIPN), was previously reported. Further patient input (qualitative interviewing, cognitive debriefing) suggested that the measure should be modified to better reflect the TIPN experience. We report the performance of a revised version (TNAS v3.0) for assessing TIPN across cancer treatments. This TNAS version incorporates extensive patient input, in accordance with FDA guidance on the development of patient-reported outcomes measures. Patients with multiple myeloma, colorectal cancer, or gynecological cancer treated with bortezomib, oxaliplatin, or taxane–platinum combination therapy, respectively, completed the TNAS v3.0, European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy (EORTC-CIPN20), and a cognitive debriefing survey during a scheduled clinic visit. Patients also participated in in-depth qualitative interviews about their TIPN symptoms. The psychometric properties of the TNAS v3.0 were evaluated. Results Cognitive debriefing survey results were summarized and showed that most patients found the items easy to complete, comprehensible, acceptable, and not redundant. A notable change from TNAS v2.0 was the separation of “numbness” from “tingling,” although these 2 items remained the most severe, followed by a new “pain” item. The Cronbach coefficient alphas for the 9-item TNAS were 0.88 and 0.90 at the first and second administrations, respectively, indicating good reliability. The test–retest reliability of the TNAS was 0.97. The correlation coefficients for the 9-item TNAS and the EORTC-CIPN20 were 0.69 for the sensory subscale, 0.70 for the motor subscale, and 0.32 for the autonomic subscale, indicating good validity. Conclusion This psychometric evaluation showed that the TNAS v3.0 is valid and reliable. Further research is needed to determine clinically meaningful differences in TNAS v3.0 scores and demonstrate its responsiveness over time.

scholarly journals Validating the Michigan Hand Outcomes Questionnaire in patients with rheumatoid arthritis using Rasch analysis

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254984
Author(s):  
Mayank Jayaram ◽  
Chang Wang ◽  
Lu Wang ◽  
Kevin C. Chung
Keyword(s):  
Rheumatoid Arthritis ◽  
Rasch Model ◽  
Rasch Analysis ◽  
Classical Test Theory ◽  
Reliability And Validity ◽  
Metacarpophalangeal Joint ◽  
Summary Score ◽  
Test Theory ◽  
Validity And Reliability ◽  
Patient Reported

Introduction The Michigan Hand Outcomes Questionnaire (MHQ) is a patient-reported outcome measure previously validated in patients with rheumatoid arthritis (RA) using classical test theory. Rasch analysis is a more rigorous method of questionnaire validation that has not been used to test the psychometric properties of the MHQ in patients with RA. The objective of this study is to evaluate the validity and reliability of the MHQ for measuring outcomes in patients with RA with metacarpophalangeal joint deformities. Methods We performed a Rasch analysis using baseline data from the Silicone Arthroplasty in Rheumatoid Arthritis (SARA) prospective cohort study. All domains were tested for threshold ordering, item fit, targeting, differential-item functioning, unidimensionality, and internal consistency. Results The Function and Work domains showed excellent fit to the Rasch model. After making adjustments, the Pain, Activities of Daily Living (ADL) and Satisfaction domains also fulfilled all Rasch model criteria. The Aesthetics domain met the majority of Rasch criteria, but could not be tested for unidimensionality. Conclusions After collapsing disordered thresholds and removing misfitting items, the MHQ demonstrated reliability and validity for assessing outcomes in patients with RA with metacarpophalangeal joint deformities. These results suggest that interpreting individual domain scores may provide more insight into a patient’s condition rather than analyzing an overall MHQ summary score. However, more Rasch analyses are needed in other RA populations before making adjustments to the MHQ.

scholarly journals Development and Content Validation of the Symptoms Evolution of COVID-19: A Patient-Reported Electronic Daily Diary in Clinical and Real-World Studies

2021 ◽  
Author(s):  
Diana Rofail ◽  
Nadine McGale ◽  
Joseph Im ◽  
Alissa Rams ◽  
Krystian Przydzial ◽  
...  
Keyword(s):  
Qualitative Research ◽  
Qualitative Interviews ◽  
Healthcare Research ◽  
Hospitalized Patients ◽  
Recall Period ◽  
Symptom Experience ◽  
Response Options ◽  
Concept Elicitation ◽  
Conceptual Clarity ◽  
Patient Reported

Importance: At the onset of the COVID-19 pandemic, there was limited understanding of symptom experience and disease progression. Objective: We developed and validated a fit-for-purpose, disease-specific instrument to assess symptoms in patients with COVID-19 to inform endpoints in an interventional trial for non-hospitalized patients. Design: The initial drafting of the 23-item Symptoms Evolution of COVID-19 (SE-C19) Instrument was developed based on the Centers for Disease Control and Prevention symptom list and available published literature specific to patients with COVID-19 as of Spring 2020. The measurement principles in the Food and Drug Administration patient-reported outcomes guidance and the four methodological Patient-Focused Drug Development Guidances were also considered. Setting: Interviews were conducted virtually with patients recruited through a healthcare research firm. Participants: Semi-structured qualitative interviews were conducted with a purposive sample of 30 non-hospitalized patients with COVID-19 Intervention: Interviews involved two stages: (1) concept elicitation, to obtain information about the symptoms experienced as a result of COVID-19 in patients' own words, and (2) cognitive debriefing, for patients to describe their understanding of the SE-C19 instructions, specific symptoms, response options, and recall period to ensure the content of the SE-C19 is relevant and comprehensive. Five clinicians treating COVID-19 outpatients were interviewed to obtain their insights on symptoms experienced by patients and provide input on the SE-C19. Main Outcome and Measure: Patients reported no issues regarding the relevance or appropriateness of the SE-C19 instructions, including the recall period. The comprehensiveness of the SE-C19 was confirmed against the conceptual model developed in the qualitative research. Minor conceptual gaps were revealed to capture nuances in the experience of nasal and gustatory symptoms, and systemic manifestations of sickness. Almost all items were endorsed by patients as being appropriate and well understood. The clinicians largely approved all items, response options, and recall period. Conclusions and Relevance: The qualitative research provided supportive evidence of the content validity of the SE-C19 instrument to assess the symptoms of outpatients with COVID-19 and its use in clinical trials to evaluate the benefit of treatment. Minor changes may be considered to improve conceptual clarity and ease of responding. Trial Registration: R10933-10987-COV-2067 (https://clinicaltrials.gov/ct2/show/NCT04425629)

scholarly journals Adaptation of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) into French-Canadian and English-Canadian

2008 ◽  
Vol 15 (2) ◽  
pp. 77-83 ◽  
Author(s):  
Donna Coffin ◽  
Karine Duval ◽  
Simon Martel ◽  
John Granton ◽  
Marie-Claude Lefebvre ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Nottingham Health Profile ◽  
Reliability And Validity ◽  
Psychometric Evaluation ◽  
Routine Practice ◽  
French Canadian ◽  
Patient Reported ◽  
Health Related Qol ◽  
Health Related ◽  
English Canadian

BACKGROUND: The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is the first disease-specific instrument for assessing patient-reported symptoms, functioning and quality of life (QoL) in pulmonary arterial hypertension (PAH).OBJECTIVES: To create and validate French-Canadian (FC) and English-Canadian (EC) language versions of the CAMPHOR.METHODS: A translation panel (for the FC version) and lay panels (for both versions) were convened to adapt the questionnaires (dual-panel methodology). Subsequently, these new questionnaires were field-tested in 15 FC PAH and 15 EC PAH patients. Finally, in a postal validation study, the new language versions of the CAMPHOR underwent psychometric evaluation in 41 FC and 52 EC PAH patients to test for reliability and validity.RESULTS: The FC and EC field-test interview participants found the questionnaires relevant, comprehensible and easy to complete. Psychometric analyses showed that the FC and EC adaptations were successful. High test-retest coefficients for the scales after controlling for change in respondent’s QoL (FC: 0.92 to 0.96; EC: 0.85 to 0.99) indicated a high degree of reliability. The FC and EC CAMPHOR scales had good internal consistency (Cronbach’s alpha coefficients 0.90 to 0.92 and 0.88 to 0.92, respectively). Predicted correlations with the Nottingham Health Profile provided evidence of the construct validity of the FC and EC scales. The FC and EC adaptations also showed known groups validity.CONCLUSIONS: The FC and EC adaptations of the CAMPHOR have been shown to be reliable and valid for measures of health-related QoL and QoL in PAH, and thus can be recommended for use in clinical studies and routine practice in PAH.

scholarly journals Qualitative and psychometric approaches to evaluate the PROMIS pain interference and sleep disturbance item banks for use in patients with rheumatoid arthritis

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Brandon Becker ◽  
Kimberly Raymond ◽  
Carol Hawkes ◽  
April Mitchell Foster ◽  
Andrew Lovley ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Sleep Disturbance ◽  
Content Validity ◽  
Sleep Disturbances ◽  
Measurement Precision ◽  
Pain Interference ◽  
Concept Elicitation ◽  
Short Forms ◽  
Item Banks ◽  
Patient Reported

Abstract Background Patients with rheumatoid arthritis (RA) commonly experience pain despite the availability of disease-modifying treatments. Sleep disturbances are frequently reported in RA, with pain often a contributing factor. The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Sleep Disturbance item banks were initially developed to provide insights into the patient experience of pain and sleep, respectively, though they were not specifically intended for use in RA populations. This study evaluated the content validity of the PROMIS Pain Interference and Sleep Disturbance item banks in RA and identified relevant content for short forms for patients with RA that achieved high measurement precision across a broad range of health. Methods A qualitative approach consisting of hybrid concept elicitation and cognitive debriefing interviews was used to evaluate the content validity of the item banks in RA. Interviews were semi-structured and open-ended, allowing a range of concepts and responses to be captured. Findings from the qualitative interviews were used to select the most relevant items for the short forms, and psychometric evaluation, using existing item-response theory (IRT) item parameters, was used to evaluate the marginal reliability and measurement precision of the short forms across the range of the latent variables (i.e. pain interference and sleep disturbance). Results Thirty-two participants were interviewed. Participants reported that RA-related pain and sleep disturbances have substantial impacts on their daily lives, particularly with physical functioning. The PROMIS Pain Interference and Sleep Disturbance item banks were easy to understand and mostly relevant to their RA experiences, and the 7-day recall period was deemed appropriate. Qualitative and IRT-based approaches identified short forms for Pain Interference (11 items) and Sleep Disturbance (7 items) that had high relevance and measurement precision, with good coverage of the concepts identified by participants during concept elicitation. Conclusion Pain and sleep disturbances affect many aspects of daily life in patients with RA and should be considered when novel treatments are developed. This study supports the use of the PROMIS Pain Interference and Sleep Disturbance item banks in RA, and the short forms developed herein have the potential to be used in clinical studies of RA.

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