Demonstrated Content Validity Research Articles

Mitigating Undergraduate Learning Burnout: Development of an Assessment Tool and Positive Thinking Training Program

The purposes of the current study were to 1) develop a learning burnout assessment for Thai undergraduate students and 2) examine the effects of a positive thinking training program on Thai undergraduate students’ learning burnout. The study was divided into two parts: the instrumental development of the assessment tool and the implementation of the positive thinking training program. The first part involved 250 undergraduate students selected using a multi-stage sampling method. The second part involved implementing the positive thinking training program with 25 participants. The results led to the creation of a learning burnout assessment tool for Thai undergraduate students, encompassing the components of emotional exhaustion, social disengagement, and academic workload. The assessment tool demonstrated content validity, construct validity, and reliability. Additionally, the positive thinking training program effectively reduced learning burnout among participants. This study contributes to the field by introducing a validated learning burnout assessment tool in the Thai educational context and demonstrating the benefits of psychological training in reducing learning burnout.

The Effect of Demographics on Investment Choice in Digital Currencies: An Empirical Study of Thai Investors

The purpose of this study is to compare the differences in Thai investors' demographic characteristics that influence their decision to invest in digital currencies. This study was quantitative research. The samples of this study were 400 Thai investors who invest in digitalcurrencies, using non-probability sampling by convenience sampling method. We employed a questionnaire as our research tool, demonstrating content validity of 1.00 and reliability of 0.70 across the entire questionnaire. We analysed the data using a one-way analysis of variance. The research discovered that different demographic factors of Thai investors, such as their age, average monthly income, duration of investments, and amount of money invested, influenced different investment decisions in digital currencies. However, the various demographic factors of Thai investors, such as their gender and level of education, did not influence different investment decisions in digital currencies. Digital currency investment providers can use these research results to develop strategies that accurately and successfully target or qualify investors.

Three Novel Patient-Reported Outcome Measures to Assess the Patient Experience with Daily and Weekly HIV Oral Antiretroviral Therapy

Background: Patient-reported outcome measures (PROMs) can provide data on the barriers and facilitators of adherence to daily oral antiretroviral therapy (OART) regimens. We aimed to develop PROMs to understand perspectives of people with HIV (PWH) on: (1) facilitators/barriers to daily OART regimen adherence; and (2) a hypothetical switch to a long-acting (LA)-OART regimen. Methods: Following US FDA PRO guidance, targeted literature reviews (TLRs) and concept elicitation interviews with clinicians (n = 7) and PWH (n = 28) were conducted to develop conceptual models (CMs) of facilitators/barriers to OART regimen adherence. Three de novo PROMs were developed after an item-generation meeting (IGM). Three waves of cognitive debriefing (CD) interviews were conducted among PWH (n = 30) to demonstrate content validity and refine the PROMs. Results: The TLR identified 25 facilitators/barriers; a further 16 were added by clinicians and PWH and represented in 2 CMs. During the IGM, the CMs were used to develop 3 de novo PROMs: (1) HIV Patient Perspective of Regimen (HIV-PP-R); (2) HIV Patient Perspective of Regimen Change (HIV-PP-RC); and (3) HIV Drivers of Adherence Questionnaire (HIV-DAQ). In the CD interviews, PWH corroborated the relevancy of items in the PROMs, and minor adjustments were made for clarity. Conclusion: Three content-valid PROMs were developed to understand treatment experience of PWH taking daily OART and how that experience may be altered upon a switch to weekly LA-OART. Data from future LA-OART clinical trials will help define a scoring guide and evaluate the structure and measurement properties of the PROMs.

Measuring persistent somatic symptom related stigmatisation: Development of the Persistent Somatic Symptom Stigma scale for Healthcare Professionals (PSSS-HCP)

ObjectivePersistent somatic symptoms (PSS) describe recurrent or continuously occurring symptoms such as fatigue, dizziness, or pain that have persisted for at least several months. These include single symptoms such as chronic pain, combinations of symptoms, or functional disorders such as fibromyalgia or irritable bowel syndrome. While stigmatisation by healthcare professionals is regularly reported, there are limited measurement instruments demonstrating content validity. This study develops a new instrument to measure stigmatisation by healthcare professionals, the Persistent Somatic Symptom Stigma scale for Healthcare Professionals (PSSS-HCP). MethodsDevelopment was an iterative process consisting of research team review, item generation and cognitive interviewing. We generated a longlist of 60 items from previous reviews and qualitative research. We conducted 18 cognitive interviews with healthcare professionals in the United Kingdom (UK). We analysed the relevance, comprehensibility and comprehensiveness of items, including the potential for social desirability bias. ResultsAfter research team consensus and initial feedback, we retained 40 items for cognitive interviewing. After our first round of interviews (n = 11), we removed 20 items, added three items and amended five items. After our second round of interviews (n = 7), we removed four items and amended three items. No major problems with relevance, comprehensibility, comprehensiveness or social desirability were found in remaining items. ConclusionsThe provisional version of the PSSS-HCP contains 19 items across three domains (stereotypes, prejudice, discrimination), demonstrating sufficient content validity. Our next step will be to perform a validation study to finalise item selection and explore the structure of the PSSS-HCP.

Developing and validating the Unhurried Conversations Assessment Tool (UCAT)

ObjectiveGiven the importance of unhurried conversations for providing careful and kind care, we sought to create, test, and validate the Unhurried Conversations Assessment Tool (UCAT) for assessing the unhurriedness of patient-clinician consultations. MethodsIn the first two phases, the unhurried conversation dimensions were identified and transformed into an assessment tool. In the third phase, two independent raters used UCAT to evaluate the unhurriedness of 100 randomly selected consultations from 184 videos recorded for a large research trial. UCAT's psychometric properties were evaluated using this data. ResultsUCAT demonstrates content validity based on the literature and expert review. EFA and reliability analyses confirm its construct validity and internal consistency. The seven formative dimensions account for 89.93% of the variance in unhurriedness, each displaying excellent internal consistency (α > 0.90). Inter-rater agreement for the overall assessment item was fair (ICC = 0.59), with individual dimension ICCs ranging from 0.26 (poor) to 0.95 (excellent). ConclusionUCAT components comprehensively assess the unhurriedness of consultations. The tool exhibits content and construct validity and can be used reliably. Practice implicationsUCAT's design and psychometric properties make it a practical and efficient tool. Clinicians can use it for self-evaluations and training to foster unhurried conversations.

How can organizations measure the integration of environmental, social, and governance (ESG) criteria? Validation of an instrument using item response theory to capture workers' perception

AbstractEvaluation of corporate sustainability parameters has become part of organizational management. Item Response Theory (IRT) serves as a valuable approach for quantifying and exploring observable variables associated with these parameters. Therefore, this article aims to propose, apply, and validate an instrument utilizing IRT to measure environmental, social, and governance (ESG) impacts on corporate sustainability performance, using the perspective of workers. Workers were chosen as key stakeholders for the present study, as they were pointed by previous research as central to corporate sustainability decisions. The present paper addresses a literature gap by introducing, implementing, and validating a research instrument, along with a comparative scale, to assess the effects of integrating ESG criteria on corporate sustainability performance. Workers of two major Brazilian electricity sector companies were respondents for this instrument. Multigroup IRT method was used to assess item discrimination and difficulty levels, and to construct a scale reflecting workers' perceptions of integrating ESG criteria. The questionnaire consisted of 15 items, demonstrating Content Validity Coefficients (CVC) above .97, confirming the instrument's content effectiveness. Cronbach's Alpha and McDonald's Omega were greater than .94 for both companies. Questionnaire items demonstrated satisfactory discrimination ability and varying difficulty levels, resulting in a five‐level scale to gauge the impacts of ESG criteria. This research contributes through the introduction and validation of the research instrument, the latent trait assessment scale, and the evaluation of workers' perceptions regarding ESG criteria impacts on corporate sustainability performance. In conclusion, the proposed instrument showed robust psychometric properties, displaying favorable reliability and validity parameters. It effectively measures the impacts of ESG criteria, providing interpretable levels aligned with the unique characteristics of its constituent items

Cross-cultural adaptation and psychometric evaluation of the “Modification of Hall’s professionalism scale for use with pharmacists”

BackgroundProfessionalism is the demonstration of behaviors that guide the actions of health professionals. In Pharmacy, its implementation is possible through assessment instruments for pharmacists, such as the “Modification of Hall’s Professionalism Scale for Use with Pharmacists”.ObjectiveTo translate the “Modification of Hall’s Professionalism Scale for Use with Pharmacists” into a Brazilian Portuguese version and evaluate its psychometric properties for pharmacists.MethodThe methodological process of this study took place in three stages: translation and cross-cultural adaptation of the instrument original version into a Brazilian Portuguese version; validation of the scale content through consensus among geographically distinct experts and, finally; examination of the scale psychometric measurement properties through a convenience sample of 600 Brazilian pharmacists. At this stage, construct validity was verified using Exploratory Factor Analysis (EFA) and reliability was examined by calculating the composite reliability.ResultsThe adapted instrument to a Brazilian Portuguese version demonstrated content validity with coefficients considered acceptable, above 0.8. The EFA demonstrated a structure supported by six factors and 39 items. The H index suggested high stability for all factors as well as composite reliability.ConclusionThe Brazilian Portuguese version of the instrument presented appropriate content validity coefficients and psychometric properties. This measure may be useful for future studies on professionalism regarding teaching strategies and assessment of this construct among pharmacists.

Assessing the validity and feasibility of using a best-worst scaling measure for values elicitation among older adults with newly-diagnosed blood cancers to inform treatment decisions.

344 Background: Multiple stakeholders have called for the development of tools to facilitate values elicitation with patients to inform treatment decision making about chemotherapy. We previously developed a best-worst scaling (BWS) measure, a theory-driven values elicitation tool, for older adults (≥ 60 years) with blood cancers through patient and expert engagement. We sought to evaluate the feasibility and validity of using this measure to inform initial treatment decisions for newly-diagnosed patients. Methods: We completed a convergent mixed-methods study to test feasibility and validity of remote delivery of the measure following guidance for choice experiments (Janssen, Exp Rev Pharm Out Res, 2017). Convergent validity was evaluated by comparing preferences with a ranking exercise. Content validity was tested in cognitive interviews. Results: 178 patients at a public safety net hospital were eligible, 157 (88%) were approached, and 48 (31%) consented (48% lymphoma, 40% leukemia/myelodysplastic syndrome, 12% other). Mean age was 73.9 years (range 60 - 95). 59% were male; 96% were white; 67% had a bachelor’s degree or higher. 52% completed the BWS measure prior to their initial treatment visit. Patients agreed or strongly agreed that the instrument was understandable (96%), relevant to them (58%), and showed their real preferences (75%). 50% felt it was easy to answer. 54% of responses from the BWS measure were concordant with ranking on their top priority. Cognitive interviews (n=7) demonstrated content validity: all patients were able to accurately describe the instructions of the BWS instrument and correctly define each included outcome; most patients reported that the BWS instrument helped solidify their preferences; all patients reported it was beneficial; no patients reported missing domains of outcomes; all reported that the time and emotional burden to complete the measure were appropriate. Conclusions: Using this BWS measure to inform treatment decisions of older adults with newly-diagnosed blood cancers is feasible and appears valid for clinical use. Future work is needed to optimize implementation and validate the measure in different settings and with a larger and more diverse population.

Qualitative Development of the Allergan Satisfaction with Treatment Experience Questionnaire (ASTEQ) Instrument, a Patient-Reported Outcome Measure in Glaucoma and Ocular Hypertension.

Sustained-release intraocular implants provide a therapeutic option for open-angle glaucoma (OAG) and ocular hypertension (OHT) patients who are non-compliant with eyedrops. Currently, there are no published patient-reported outcome (PRO) measures that assess treatment satisfaction with intraocular implants. To address this gap, a new PRO instrument, the Allergan Satisfaction with Treatment Experience Questionnaire (ASTEQ), has been developed in accordance with Food and Drug Administration guidance. Qualitative research interviews were conducted among patients with OAG/OHT who had received three intraocular injections of a sustained-release bimatoprost (10 or 15µg) implant within the clinical trial setting. A preliminary conceptual framework capturing treatment satisfaction concepts in glaucoma, as identified from the literature, was used to develop a semi-structured interview guide. A concept elicitation (CE) interview to identify aspects of the glaucoma treatment experience pertinent to intraocular implants provided content for a draft instrument. A cognitive debriefing (CD) interview to test the instrument's interpretability, relevance, and validity informed its subsequent refinement. Interview analysis followed a grounded theory approach to identify data patterns and relationships. CE interviews (n = 19) indicated that participants' main considerations in rating satisfaction with implant treatment were physical comfort during preparation for the implant and implant administration, anxiety about the procedure, frequency of implant administration, possible side effects, convenience and accessibility of the implant, relationship with the clinician, and lifestyle fit. Draft ASTEQ revision based on CD interviews (n = 20) and readability tests yielded a nine-item ASTEQ instrument comprising satisfaction with overall implant experience and frequency of administration, occurrence/bother of immediate and long-term side effects, worry about implant administration and possible risks/side effects, and physical discomfort during preparation for the implant and implant administration. The ASTEQ instrument has demonstrated content validity in patients with OAG/OHT treated with a sustained-release bimatoprost implant. Further research is necessary to evaluate its psychometric properties.

Measuring dengue illness intensity: Development and content validity of the dengue virus daily diary (DENV-DD)

BackgroundDengue is the most prevalent arboviral infection causing an estimated 50–60 million cases of febrile illness globally per year, exacting considerable disease burden. Few instruments exist to assess the patient illness experience, with most based on healthcare provider assessment, lacking standardization in timepoints and symptom assessment. This study aimed to evaluate the content validity of the novel ‘Dengue Virus Daily Diary (DENV-DD)’, designed to measure symptom intensity and disease burden within outpatient infant to adult populations.MethodsThe Dengue Illness Index Report Card was used as a foundation to create the DENV-DD, consisting of patient- and observer-reported outcome (PRO/ObsRO) instruments. In two South American dengue-endemic communities, qualitative combined concept elicitation and cognitive debriefing interviews were conducted among individuals and caregivers of children with symptomatic laboratory-confirmed dengue. Interviews were conducted across two rounds allowing DENV-DD modifications. A small-scale quantitative assessment of the DENV-DD was also conducted with data from an independent Dengue Human Infection Model (DHIM) to generate early evidence of feasibility of DENV-DD completion, instrument performance and insight into the sign/symptom trajectory over the course of illness.ResultsForty-eight participants were interviewed (20 adults, 20 older children/adolescents with their caregivers, 8 caregivers of younger children). A wide spectrum of signs/symptoms lasting 3–15 days were reported with fever, headache, body ache/pain, loss of appetite, and body weakness each reported by > 70% participants. DENV-DD instructions, items and response scales were understood, and items were considered relevant across ages. DHIM data supported feasibility of DENV-DD completion.ConclusionsFindings demonstrate content validity of the DENV-DD (PRO/ObsRO instruments) in dengue-endemic populations. Psychometric and cultural validity studies are ongoing to support use of the DENV-DD in clinical studies.

Development of the self-regulation assessment and content validation using cognitive interviews in a multicultural post-rehabilitation population.

Self-regulation is one of the main goals of medical rehabilitation. Four themes of self-regulation were identified by former patients and rehabilitation physicians in a previous study. Based on these themes, a measure for self-regulation, the self-regulation assessment (SeRA), was developed. This study aimed to establish the content validity of the SeRA in a multicultural and multi-diagnostic post-rehabilitation population. The Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology was applied. First, cognitive interviews were held with eight former rehabilitation patients. Feedback was obtained on relevance, comprehensibility, and comprehensiveness of the items. Items with problems were revised. Then, a second series of cognitive interviews was held with 16 former rehabilitation patients with non-Western migration backgrounds. Again, feedback was obtained on relevance, comprehensibility, and comprehensiveness of the items. The first series of cognitive interviews revealed good comprehensiveness, and also comprehensibility or relevance problems with 12 of the 25 items. These items were revised or deleted. Two missing concepts were identified and these were added. There was no need to revise the items based on the results of the second series of cognitive interviews. The final version of the SeRA demonstrated content validity for the studied population. The measure is ready for psychometric analyses in subsequent validation studies.

Validation of the Foot and Ankle Outcome Score for Use in Infracalcaneal Heel Pain

There is growing interest in adopting validated and reliable patient-reported outcome measures following surgery. While the Foot and Ankle Outcome Score (FAOS) has previously been validated for use in multiple foot/ankle conditions, it has not yet been validated in patients with infracalcaneal heel pain. In this study we aimed to validate the FAOS by looking at 4 psychometric properties of the survey: construct validity, content validity, reliability, and responsiveness, using patients in our practice with a clinical diagnosis of plantar fasciitis. A total of 150 patients (mean age 49.7 ± 12.1 years [36 men and 114 women]) were included in one or more of the 4 components of this study. All FAOS subscales demonstrated adequate construct validity when compared with the physical health component of the 12-Item Short Form Health Survey (SF-12), and 2 out of 5 subscales demonstrated moderate correlation with the mental health component of SF-12 (all Spearman rho >0.3, and p values <0.05). Most FAOS subscales demonstrated content validity and were found to contain relevant questions from the patient's perspective. All 5 subscales demonstrated good test-retest reliability with intraclass correlation coefficients ≥ 0.827. Finally, 4 out of the 5 subscales (all but other symptoms) were responsive to change at a mean follow up of 12.2 months after surgery (p < .05). We conclude that the FAOS is a responsive, reliable, and valid instrument for use in infracalcaneal heel pain. We believe that due to its ease of use and broad applicability, the FAOS could be more widely adopted in foot/ankle practices as patient-centered healthcare delivery and research becomes increasingly prioritized in the US and abroad.

The Roswell eND scale: Brief, valid assessment of nicotine dependence adults seeking to discontinue e-cigarette use

BackgroundMost adults who regularly use e-cigarettes or Electronic Nicotine Delivery Systems (ENDS) desire to discontinue use. ENDS use can result symptoms of nicotine withdrawal and dependence which can make it more difficult to discontinue use. Brief, valid assessment of nicotine dependence among adults who use ENDS is needed to guide treatment for nicotine dependence in this group. We sought to develop a brief, valid instrument to measure nicotine dependence among adults seeking to discontinue ENDS in a busy Quitline. MethodsIn this cross-sectional design, we examined content, construct, and concurrent validity of the Roswell ENDS Nicotine Dependence Scale (Roswell eND Scale) and the Penn State E-Cigarette Dependence Index (Penn State eCDI). Participants who called the New York Quitline from November 2019 to June 2020 seeking to discontinue ENDS use were invited to participate. Construct validity was examined with exploratory and confirmatory factor analyses. Instrument and factor scores were then correlated with cotinine, a biomarker of nicotine exposure. ResultsAll participants (n = 209) were highly dependent and co-used combustible cigarettes to varying degrees. Both instruments demonstrated content validity and construct validity, however only the 5-item Roswell eND Scale demonstrated criterion-related validity by showing a significant positive correlation with salivary cotinine levels. ConclusionsThe 5-item Roswell eND Scale can briefly and effectively assess nicotine dependence among treatment-seeking adults who co-use ENDS and cigarettes. These preliminary psychometric findings have the potential to be generalizable to other adults seeking to discontinue ENDS use, many of whom currently or formerly smoked cigarettes.

Content Validation of the Movement Disorder-Childhood Rating Scale (MD-CRS) for Dyskinetic Cerebral Palsy

BackgroundDyskinetic cerebral palsy (DCP), a lifelong neurological disorder beginning in early childhood, manifests with hyperkinetic movements and dystonia. The Movement Disorder-Childhood Rating Scale (MD-CRS) is a clinician-reported outcome measure assessing the intensity of movement disorders and their effect on daily life in pediatric patients. Content validity of clinical outcome assessments is key to accurately capturing patient perspective. Evidence demonstrating content validity of the MD-CRS in patients with DCP is needed. This study captures input from patients with DCP and their caregivers regarding the content validity of the MD-CRS. MethodsThis qualitative, noninterventional, cross-sectional study included interviews with children/adolescents (aged six to 18 years) with DCP and caregivers of children with DCP. Participants were asked to describe body regions and daily functions affected by DCP. Caregivers also reviewed MD-CRS Part I to evaluate the relevance of the items and corresponding response options. Descriptions of DCP were coded and mapped to MD-CRS items and response options. Caregiver feedback on MD-CRS Part I was analyzed using inductive content analysis. ResultsEight patients and 12 caregivers were interviewed. Participants confirmed that the body regions and activities listed in the MD-CRS were affected by DCP and that involuntary movements interfered with all motor, oral/verbal, self-care, and video protocol activities. Caregivers endorsed the response options for 12 of 15 items in MD-CRS Part I and suggested clarifications for others. ConclusionsParticipants confirmed that affected body regions and activities listed in the MD-CRS were relevant to their experience with DCP, demonstrating the content validity of this tool in children/adolescents with DCP.

Content validation using Aiken methodology through expert judgment of the first Spanish version of the Eppendorf Schizophrenia Inventory (ESI) in Peru: A brief qualitative report

BackgroundThe main objective of this study was the validation through the expert judgment of the first Spanish version of the Eppendorf Schizophrenia Inventory (ESI-Sp). Materials and methodsA translation and cultural adaptation procedure as a first stage was carried out, which was evaluated by four psychiatrists with clinical experience. In a second stage, we recruited a group of clinical psychiatrists to evaluate the translated instrument by judging the items’ clarity and relevance. Content validity was performed using the Aiken methodology (Aiken's V). ResultsFor the first stage, we did not find any items that needed alteration during translation and adaptation. Concerning the raters’ stage, 30 clinical psychiatrists (47.07±13.62 years) completed the rating of the ESI-Sp. Of them, the majority worked in an institute (10/30; 33.33%) and had “15 or more” years of experience (12/30; 40.00%). The null hypothesis was rejected for all items and demonstrated the content validity of each item. Similar results were found for the factors of the ESI. Finally, the total Aiken's V for the ESI did not include the values of the null hypothesis in the confidence intervals (V=0.78; CI95 [0.70; 0.85]), demonstrating content validity. ConclusionsESI-Sp is a valid and representative instrument to determine subjective experiences in patients with a high risk of schizophrenia. The construct validation of the ESI-Sp is pending, which our research group will carry out after this first step.

PCR253 Establishing Content Validity of Three New Patient Reported Outcome (PRO) Measures for Use in HIV Long-Acting Oral Antiretroviral Therapy (LA-OART) Clinical Trials

Long-acting oral antiretroviral therapy (LA-OART) is in development for people living with HIV (PLWH). This study aimed to demonstrate content validity of patient reported outcome (PRO) measures for use within LA-OART clinical trials. Previously, a targeted literature review and concept elicitation interviews with clinicians and PLWH were conducted to develop conceptual models (CMs) capturing PLWH experiences of OART, adherence facilitators and barriers, and perspectives on a hypothetical switch to LA-OART.

An Instrument for Measuring Critical Appraisal Self-Efficacy in Rheumatology Trainees.

Self-efficacy, the internal belief that one can perform a specific task successfully, influences behavior. To promote critical appraisal of medical literature, rheumatology training programs should foster both competence and self-efficacy for critical appraisal. This study aimed to investigate whether select items from the Clinical Research Appraisal Inventory (CRAI), an instrument measuring clinical research self-efficacy, could be used to measure critical appraisal self-efficacy (CASE). One hundred twenty-five trainees from 33 rheumatology programs were sent a questionnaire that included two sections of the CRAI. Six CRAI items relevant to CASE were identified a priori; responses generated a CASE score (total score range 0-10; higher=greater confidence in one's ability to perform a specific task successfully). CASE scores' internal structure and relation to domain-concordant variables were analyzed. Questionnaires were completed by 112 of 125 (89.6%) trainees. CASE scores ranged from 0.5 to 8.2. The six CRAI items contributing to the CASE score demonstrated high internal consistency (Cronbach's α=0.95) and unidimensionality. Criterion validity was supported by the findings that participants with higher CASE scores rated their epidemiology and biostatistics understanding higher than that of peers (P < 0.0001) and were more likely to report referring to studies to answer clinical questions (odds ratio 2.47, 95% confidence interval 1.41-4.33; P=0.002). The correlation of CASE scores with percentage of questions answered correctly was only moderate, supporting discriminant validity. The six-item CASE instrument demonstrated content validity, internal consistency, discriminative capability, and criterion validity, including correlation with self-reported behavior, supporting its potential as a useful measure of critical appraisal self-efficacy.

Conceptual Framework for Patient-Reported Outcome Measures in Clinical Trials of Skeletal Muscle Cramping Experienced in Dialysis: A Kidney Health Initiative Workgroup Report.

Skeletal muscle cramping is a common and bothersome symptom for patients on maintenance dialysis therapy, regardless of modality, and it has not been prioritized for innovative assessments or treatments. Research to prevent or treat skeletal muscle cramping in patients receiving dialysis is hindered by poorly understood pathophysiology, lack of an accepted definition, and the absence of a standardized measurement method. The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a multidisciplinary workgroup to define a set of patient-reported outcome measures for use in clinical trials to test the effect of new dialysis devices, new KRTs, lifestyle/behavioral modifications, and medications on skeletal muscle cramping. Upon determining that foundational work was necessary, the workgroup undertook a multistep process to elicit concepts central to developing the basis for demonstrating content validity of candidate patient-reported outcome measures for skeletal muscle cramping in patients on dialysis. The workgroup sought to (1) create an accepted, patient-endorsed definition for skeletal muscle cramping that applies to all dialysis modalities, (2) construct a conceptual model for developing and evaluating a skeletal muscle cramping-specific patient-reported outcome measure, and (3) identify potential questions from existing patient-reported outcome measures that could be modified or adapted and subsequently tested in the dialysis population. We report the results of the workgroup's efforts, provide our recommendations, and issue a call to action to address the gaps in knowledge and research needs we identified. These action steps are urgently needed to quantify skeletal muscle cramping burden, assess the effect, and measure meaningful changes of new interventions to improve the experience of patients receiving dialysis and suffering from skeletal muscle cramping.

111EMF Exploration of Uncertainty Scale Use in Patients With Potential Acute Coronary Syndrome

Patients seeking care in the emergency department (ED) identify fear related to ongoing symptoms and uncertainty about symptom significance as common drivers of the decision to seek care. These findings resulted in development of the Uncertainty Scale (U-Scale) to quantify patient uncertainty related to symptoms during an acute care encounter. In prior work, psychometric testing of the 30-item U-Scale demonstrated content validity, high internal consistency, reliability, and evidence for concurrent validity.

Content Validity of Sjögren's Syndrome Symptom Diary and Functional Assessment of Chronic Illness Therapy-Fatigue in Patients with Sjögren's.

IntroductionSjögren’s Syndrome Symptom Diary (SSSD) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) are patient-reported outcome (PRO) instruments assessing Sjögren’s symptoms. Original SSSD items have demonstrated content validity, however qualitative evidence supporting the updated ‘tiredness’ item and two new supplementary items is lacking. Although well established and validated in other rheumatic diseases, there is no qualitative evidence supporting content validity of FACIT-F in Sjögren’s. This study addressed these evidence gaps to support use of SSSD and FACIT-F as clinical trial endpoints, in clinical practice and in other research settings.MethodsQualitative, semi-structured telephone interviews were conducted with patients with Sjögren’s (n = 12) and expert Sjögren’s physicians (n = 10). Patient interviews explored content validity (e.g., understanding and relevance) of the new and updated SSSD items, perceptions of item and total score meaningful change on SSSD, and understanding and relevance of FACIT-F items. Physician interviews explored opinions on various SSSD scoring approaches.ResultsThe new and updated SSSD items and FACIT-F demonstrated good content validity. Most patients considered a two-point improvement on most SSSD items meaningful, as well as a one- or two-point total score improvement. Most physicians reported tracking changes in patient responses to individual items as the most appropriate SSSD scoring approach.ConclusionsSSSD and FACIT-F are content valid in a Sjögren’s population, meeting an important criterion to support their use as clinical trial endpoints, but also their use in clinical practice and other research settings. Qualitative data exploring meaningful change will be valuable in supporting psychometrically derived responder definitions.