Dataset Information

Development and Content Validity of the Statin Experience Assessment Questionnaire (SEAQ)©.

ABSTRACT:

Introduction

The National Lipid Association Statin Intolerance (SI) Panel recognized the need for better understanding of the patient SI experience.

Objective

The objective of this research was to develop a patient-reported outcome (PRO) questionnaire to assess a patient's experience with SI.

Methods

Questionnaire development was informed via a series of research activities: literature review, concept elicitation, item generation, and content evaluation. Following the literature review and concept elicitation, a draft questionnaire was constructed and subsequently modified based on feedback from therapeutic area experts and patients via cognitive debriefing interviews.

Results

Muscle-related symptoms were the most commonly reported symptoms associated with SI in the literature review (35 of 41 articles reviewed [85%]) and in semi-structured interviews with experts (n = 5 [100%]) and patients (n = 17 of 20 [85.0%]). Physical and other impacts of SI symptoms on daily activities were also frequently reported. A 17-item draft questionnaire was created, and cognitive debriefing with experts (n = 5) and patients (n = 15) was conducted. Overall, the items, response options, and instructions were comprehensible and positively reviewed; minor changes resulted in the 15-item Statin Experience Assessment Questionnaire (SEAQ)©. Using a 30-day recall period, the SEAQ© assesses the severity and impact of six SI symptoms (muscle ache, muscle pain, muscle cramps, muscle weakness, tiredness, and joint pain) on an 11-point numeric scale. Statin discontinuation and likelihood of discontinuation due to symptoms are assessed and scored on a yes/no and five-point verbal response scale, respectively.

Conclusion

The SEAQ

SUBMITTER: Jacobson TA

PROVIDER: S-EPMC5422451 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Jacobson Terry A TA Edelman Steven V SV Galipeau Nina N Shields Alan L AL Mallya Usha G UG Koren Andrew A Davidson Michael H MH

The patient 20170601 3

<h4>Introduction</h4>The National Lipid Association Statin Intolerance (SI) Panel recognized the need for better understanding of the patient SI experience.<h4>Objective</h4>The objective of this research was to develop a patient-reported outcome (PRO) questionnaire to assess a patient's experience with SI.<h4>Methods</h4>Questionnaire development was informed via a series of research activities: literature review, concept elicitation, item generation, and content evaluation. Following the liter ...[more]

PMID: 27981439

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Project description:PURPOSE:Develop and establish the content validity of the Behavioral Assessment Screening Tool (BAST?), a self-reported measure of behavioral and emotional symptoms after traumatic brain injury. METHODS:This was an assessment development study, including two focus groups of individuals with traumatic brain injury (n?=?11) and their family members (n?=?10) and an expert panel evaluation of content validity by experts in traumatic brain injury rehabilitation (n?=?7). We developed and assessed the Content Validity Index of the BAST?. RESULTS:The BAST? initial items (n?=?77) corresponded with an established conceptual model of behavioral dysregulation after traumatic brain injury. After expert panel evaluation and focus group feedback, the final BAST? included 66 items (60 primary, 6 branching logic) rated on a three-level ordinal scale (Never, Sometimes, Always) with reference to the past two weeks, and an Environmental Context checklist including recent major life events (n?=?23) and four open-ended questions about environmental factors. The BAST? had a high Content Validity Index of 89.3%. CONCLUSION:The BAST? is a theoretically grounded, multidimensional self-reported assessment of behavioral dysregulation after traumatic brain injury, with good content validity. Future translation into mobile health modalities could improve effectiveness and efficiency of long-term symptom monitoring post-traumatic brain injury. Future work will establish and validate the factor structure, internal consistency reliabilities and other validities of the BAST. Implications for Rehabilitation Behavioral problems after traumatic brain injury is one of the strongest contributing factors to poor mood and community integration outcomes after injury. Behavior is complex and multidimensional, making it a challenge to measure and to monitor long term. The Behavioral Assessment Screening Tool (BAST) is a patient-oriented outcome assessment developed in collaboration with individuals with traumatic brain injury, their care partners, and experts in the field of traumatic brain injury rehabilitation to be relevant and accessible for adults with traumatic brain injuries. The BAST is a long-term monitoring and screening tool for community-dwelling adults with traumatic brain injuries, to improve identification and management of behavioral and emotional sequelae.

Project description:BackgroundDry eye disease (DED), Meibomian gland dysfunction (MGD), and Sjögren's syndrome dry eye disease (SS-DED) are eye dryness conditions that show significant overlap in various symptoms of ocular discomfort. The aim of this study was to qualitatively explore the patient experience and evaluate content validity of the newly developed Dry Eye Disease Questionnaire (DED-Q).MethodsSemi-structured interviews were conducted with 61 US adults who reported experiencing ocular symptoms due to their physician-confirmed primary diagnosis of DED (n = 21), MGD (n = 20), or SS-DED (n = 20). The open-ended concept-elicitation phase was followed by cognitive debriefing (CD) of the DED-Q to evaluate participants' understanding and relevance of the instructions, items, response options, and recall periods. Interviews were also conducted with eight specialist healthcare professionals to assess clinical relevance of the concepts included. Verbatim interview transcripts were analyzed using thematic analysis in ATLAS.ti v8 software.ResultsA total of 29 symptoms and 14 impacts on quality of life were reported across participant interviews. Primary ocular symptoms reported included eye dryness (n = 61/61; 100%), eye irritation (n = 55/61; 90%), eye itch (n = 54/61; 89%), burning sensation (n = 52/61; 85%), and foreign body sensation (n = 51/61; 84%). The most impacted aspects of daily life were using digital screens (n = 46/61; 75%), driving (n = 45/61; 74%), working (n = 39/61; 64%), and reading (n = 37/61; 61%). CD findings showed most participants had good understanding of DED-Q items and confirmed most concepts were relevant to the lived experience of their condition. Aside from few minor changes to the items and examples to facilitate more accurate interpretation, the proposed instruction wording was modified for various symptom and impact modules to encourage participants to focus only on dry eye vision problems.ConclusionsThis research identified multiple prevalent symptoms and impacts of DED, MGD, and SS-DED, most of which were similar across the conditions. The DED-Q was confirmed to be a content-valid PRO measure suitable for use in clinical studies to assess the patient experience of DED, MGD, and SS-DED. Future work will focus on evaluating the psychometric properties of the DED-Q for use as an efficacy endpoint in clinical trials.

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Project description:BACKGROUND: A new caregiver burden questionnaire for heart failure (CBQ-HF v1.0) was developed based on previously conducted qualitative interviews with HF caregivers and with input from HF clinical experts. Version 1.0 of the CBQ-HF included 41 items measuring the burden associated with caregiving in the following domains: physical, emotional/psychological, social, and impact on caregiver's life. Following initial development, the next stage was to evaluate caregivers' understanding of the questionnaire items and their conceptual relevance. METHODS: To evaluate the face and content validity of the new questionnaire, cognitive interviews were conducted with caregivers of heart failure patients. The cognitive interviews included a "think aloud" exercise as the patient completed the CBQ-HF, followed by more specific probing questions to better understand caregivers' understanding, interpretation and the relevance of the instructions, items, response scales and recall period. RESULTS: Eighteen caregivers of heart failure patients were recruited. The mean age of the caregivers was 50 years (SD?=?10.2). Eighty-three percent of caregivers were female and most commonly the patient was either a spouse (44%) or a parent (28%). Among the patients 55% were NYHA Class 2 and 45% were NYHA Class 3 or 4. The caregiver cognitive interviews demonstrated that the CBQ-HF was well understood, relevant and consistently interpreted. From the initial 41 item questionnaire, fifteen items were deleted due to conceptual overlap and/or item redundancy. The final 26-item CBQ-HF (v3.0) uses a 5-point Likert severity scale, assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens using a 4-week recall period. CONCLUSIONS: The CBQ-HF (v3.0) is a comprehensive and relevant measure of subjective caregiver burden with strong content validity. This study has established that the CBQ-HF (v3.0) has strong face and content validity and should be valuable as an outcomes measure to help understand and monitor the relationship between patient heart failure severity and caregiver burden. A Translatability AssessmentSM of the measure has since been performed confirming the cultural appropriateness of the measure and psychometric validation is planned for the future to further explore the reliability, and validity of the new questionnaire in a larger caregiver sample.

Dataset Information

Development and Content Validity of the Statin Experience Assessment Questionnaire (SEAQ)©.

Introduction

Objective

Methods

Results

Conclusion

Publications

Development and Content Validity of the Statin Experience Assessment Questionnaire (SEAQ)©.

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