Dataset Information

T66. PSYCHOMETRIC VALIDATION OF A NOVEL PATIENT-REPORTED OUTCOME MEASURE FOR ASSESSING PATIENTS’ SUBJECTIVE EXPERIENCE OF COGNITIVE IMPAIRMENT OF SCHIZOPHRENIA (PRECIS)

ABSTRACT: Abstract Background We have previously described the development and content validity of a new patient-reported outcome measure (PRO) to assess patients’ subjective experience of cognitive impairment in schizophrenia: The Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS). Here we assess the psychometric properties of the PRECIS PRO in patients with schizophrenia and healthy age-matched controls with the aim of developing a revised version for use in clinical studies. Methods The PRECIS PRO is a 35-item scale comprising eight concept domains (memory, communication, control, planning, handling problems, attention, sharp thinking and overall experience), each with multiple individual items. PRECIS was administered to psychiatrically-healthy controls (single visit), and a subset of patients in a large, clinical trial assessing patients with schizophrenia on stable antipsychotic treatment (NCT02281773) at baseline and Weeks 6, 9 and 12. Analysis of the original 35-item PRECIS PRO included factor structure, factor analysis (FA), internal consistency, test-retest reliability and discriminant (known groups) validity testing. FA was performed on all pre-treatment scores in the patient group (n=410) and patients and controls combined (n=498). Individual items with less than adequate reliability or validity were then identified and eliminated or modified. Results Questionnaire responses were collected from 410 patients with schizophrenia and 88 healthy controls. The mean (standard deviation [SD]) total PRECIS score was significantly lower for healthy controls (1.39 [0.7]) compared with patients (2.06 [1.2]; p<0.0001), as was overall experience domain score (1.41 [0.7] vs 2.35 [1.3]; p<0.0001). For each domain of patient experience, PRECIS mean scores were also significantly lower for healthy controls compared to patients with schizophrenia. The mean differences between groups ranged from -0.94 (overall experience domain) to -0.52 (control domain; p<0.0001, all domains). Patients with schizophrenia had wider response distributions compared with controls, while the control group had marked “floor effects” across most items. Initial exploratory FA of the 35-item PRECIS PRO identified a 6-domain solution that accounted for 62% of total item variance, and Cronbach’s alpha (0.959) indicated an extremely high level of internal consistency. Following analyses of the 35-item PRECIS PRO, a total of 11 items were eliminated based on pre-specified criteria (poor loading onto identified factors, marked floor effects in patient groups or <50% test-retest reliability). Confirmatory FA of the revised 24-item PRECIS PRO identified 1 primary domain (attention) and 3 secondary additional domains (memory, executive function, communication). An additional domain included items related to patient distress or bother related to cognitive impairment. There was a high level of internal consistency both for the overall 24-item PRECIS PRO (Cronbach’s alpha= 0.942) and individual domains (Cronbach’s alphas: 0.743–0.873). Intraclass correlation coefficients were 0.78 for the overall 24-item PRECIS PRO and ranged from 0.49–0.74 for individual domains. Finally, discriminant validity testing confirmed there were significant differences between the patient group and the control group in each of the 5 domains of the revised 24-item PRECIS PRO (p<0.0001). Discussion This large validation study demonstrated that the revised 24-item PRECIS PRO is a valid and reliable PRO measure with good internal consistency, adequate test-retest reliability and strong discriminant validity. PRECIS may therefore serve to define key patient-based endpoints for use in future clinical studies. Funding Boehringer Ingelheim (1289.20)

SUBMITTER: Rosen R

PROVIDER: S-EPMC5888376 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundRespiratory syncytial virus (RSV) causes significant morbidity and mortality in older adults. Despite a number of RSV vaccine candidates in clinical trials, there are no existing disease-specific, self-reported measures that assess the symptoms and severity of RSV infection from the perspective of adult patients with acute RSV. The objective of this study was to describe the initial conceptualization and development of the RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ), a new patient-reported outcome measure.MethodsA targeted review of the literature identified relevant existing measures, symptoms, and impacts of RSV. A draft version of the RSV-iiiQ was developed based on the Influenza Intensity and Impact Questionnaire (Flu-iiQ) with expert input. Qualitative interviews (N = 20) were conducted with participants to optimize the RSV-iiiQ conceptual model and confirm the content validity of the RSV-iiiQ. Interviews included concept elicitation and a cognitive debriefing assessment. A draft conceptual framework was developed, and the electronic clinical outcome assessment was piloted. All steps of instrument development followed Food and Drug Administration guidance for patient-reported outcomes.ResultsIn-depth concept elicitation interviews followed by cognitive debriefings demonstrated that the content of the items was comprehensive, covered the breadth of RSV symptoms and impacts, and was relevant to the experiences of individuals with RSV. Both the paper and electronic versions of the RSV-iiiQ were easily completed. Minor refinements were made to some items based on participant feedback, and the draft conceptual framework was refined.ConclusionsThe RSV-iiiQ was developed for use in clinical trials to measure the symptom intensity and impact of acute RSV infection from the perspective of adult patients. The tool was developed in accordance with current regulatory guidance and is useful to support patient-focused drug development.

Project description:BackgroundThe experience sampling method (ESM) holds advantages over traditional retrospective questionnaires including a high ecological validity, no recall bias, the ability to assess fluctuation of symptoms, and the ability to analyze the temporal relationship between variables.ObjectiveThis study aimed to evaluate the psychometric properties of an endometriosis-specific ESM tool.MethodsThis is a short-term follow-up prospective study, including patients with premenopausal endometriosis aged ≥18 years who reported dysmenorrhea, chronic pelvic pain, or dyspareunia between December 2019 and November 2020. An ESM-based questionnaire was sent out by a smartphone application 10 times a day during 1 week on randomly chosen moments. Additionally, patients completed questionnaires concerning demographics, end-of-day pain scores, and end-of-week symptom scores. The psychometric evaluation included compliance, concurrent validity, and internal consistency.ResultsTwenty-eight patients with endometriosis completed the study. Compliance for answering the ESM questions was as high as 52%. End-of-week pain scores were higher than ESM mean scores and showed peak reporting. ESM scores showed strong concurrent validity when compared with symptoms scored by the Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome, 7-item Generalized Anxiety Disorders Scale, 9-question Patient Health Questionnaire, and the majority of questions of the 30-item Endometriosis Health Profile. Cronbach α coefficients demonstrated a good internal consistency for abdominal symptoms, general somatic symptoms, and positive affect, and an excellent internal consistency for negative affect.ConclusionsThis study supports the validity and reliability of a newly developed electronic instrument for the measurement of symptoms in women with endometriosis, based on momentary assessments. This ESM patient-reported outcome measure has the advantage of providing a more detailed view on individual symptom patterns and offers the possibility for patients to have insight in their symptomatology, leading to more individualized treatment strategies that can improve the quality of life of women with endometriosis.

Project description:Introduction Poor medication adherence is associated with worsening patient health outcomes and increasing healthcare costs. A holistic tool to assess both medication adherence and drivers of adherence behaviour has yet to be developed. This study aimed to examine SPUR, a multifactorial patient-reported outcome measure of medication adherence in patients living with type 2 diabetes, with a view to develop a suitable model for psychometric analysis. Furthermore, the study aimed to explore the relationship between the SPUR model and socio-clinical factors of medication adherence. Research design and methods The study recruited 378 adult patients living with type 2 diabetes from a mix of community and secondary-care settings to participate in this non-interventional cross-sectional study. The original SPUR-45 tool was completed by participants with other patient-reported outcome measures for comparison, in addition to the collection of two objective adherence measures; HbA1c and the medication possession ratio (MPR). Results Factor and reliability analysis conducted on SPUR-45 produced a revised and more concise version (27-items) of the tool, SPUR-27, which was psychometrically assessed. SPUR-27 observed strong internal consistency with significant correlations to the other psychometric measures (Beliefs about Medication Questionnaire, Diabetes Treatment Satisfaction Questionnaire, Medicine Adherence Rating Scale) completed by participants. Higher SPUR-27 scores were associated with lower HbA1c values and a higher MPR, as well as other predicted socio-clinical factors such as higher income, increased age and lower body mass index. Conclusions SPUR-27 demonstrated strong psychometric properties. Further work should look to examine the test–retest reliability of the model as well as examine transferability to other chronic conditions and broader population samples. Overall, the initial findings suggest that SPUR-27 is a reliable model for the multifactorial assessment of medication adherence among patients living with type 2 diabetes.

Project description:BackgroundThe Urgency Numeric Rating Scale (NRS) was developed as a content-valid single-item patient-reported outcome measure to assess severity of bowel urgency. Here, we evaluated the psychometric properties of the Urgency NRS.MethodsData were from a multicenter, randomized, placebo-controlled phase 3 trial in adults with moderately to severely active ulcerative colitis (NCT03518086). Patients completed the Urgency NRS using a daily electronic diary, from which weekly average Urgency NRS scores were calculated. Test-retest reliability, known-groups validity, construct validity, responsiveness, and score interpretation were assessed using the modified Mayo score, Inflammatory Bowel Disease Questionnaire (IBDQ), Patient Global Rating of Severity (PGRS), Patient Global Rating of Change (PGRC), and Geboes score.ResultsThe study sample comprised 1,162 participants (40.2% female). Mean Urgency NRS score was higher (worse) at baseline than at week 12 (6.2 vs. 3.7). Test-retest reliability was strong, with intra-class correlation coefficients of 0.76-0.89. Baseline least-square mean Urgency NRS score was higher for participants with a PGRS score greater than the median (worse symptoms) than for those with a PGRS score less than or equal to the median (7.5 vs. 5.4; p < 0.0001), indicating good known-groups validity. Urgency NRS score was moderately correlated with IBDQ total and domain scores, PGRS, PGRC, and modified Mayo stool frequency, establishing its convergent validity. Correlations were weak for Geboes score and weak to moderate for modified Mayo endoscopic subscore and modified Mayo rectal bleeding, indicating that the Urgency NRS also had discriminant validity. Patients achieving clinical remission, clinical response, IBDQ remission, and PGRS score improvement showed significantly greater improvement on the Urgency NRS (p < 0.0001 for all), demonstrating responsiveness to change. A ≥ 3-point improvement in Urgency NRS score represented a meaningful improvement in bowel urgency and an Urgency NRS score of ≤ 1 point represented a bowel urgency remission threshold that was closely associated with clinical, endoscopic, and histologic remission.ConclusionsThe Urgency NRS is a valid and reliable patient-reported outcome measure that is suitable for evaluating treatment benefits in clinical trials in patients with moderately to severely active ulcerative colitis.

Dataset Information

T66. PSYCHOMETRIC VALIDATION OF A NOVEL PATIENT-REPORTED OUTCOME MEASURE FOR ASSESSING PATIENTS’ SUBJECTIVE EXPERIENCE OF COGNITIVE IMPAIRMENT OF SCHIZOPHRENIA (PRECIS)

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets