Psychometric Characteristics of a Patient Reported Outcome Measure on Ego-Integrity and Despair among Cancer Patients.
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ABSTRACT:
SUBMITTER: Kleijn G
PROVIDER: S-EPMC4873008 | biostudies-other | 2016
REPOSITORIES: biostudies-other
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Project description:Traumatic brain injury (TBI) may lead to impairments in various outcome domains. Since most instruments assessing these are only available in a limited number of languages, psychometrically validated translations are important for research and clinical practice. Thus, our aim was to investigate the psychometric properties of the patient-reported outcome measures (PROM) applied in the CENTER-TBI study. The study sample comprised individuals who filled in the six-months assessments (GAD-7, PHQ-9, PCL-5, RPQ, QOLIBRI/-OS, SF-36v2/-12v2). Classical psychometric characteristics were investigated and compared with those of the original English versions. The reliability was satisfactory to excellent; the instruments were comparable to each other and to the original versions. Validity analyses demonstrated medium to high correlations with well-established measures. The original factor structure was replicated by all the translations, except for the RPQ, SF-36v2/-12v2 and some language samples for the PCL-5, most probably due to the factor structure of the original instruments. The translation of one to two items of the PHQ-9, RPQ, PCL-5, and QOLIBRI in three languages could be improved in the future to enhance scoring and application at the individual level. Researchers and clinicians now have access to reliable and valid instruments to improve outcome assessment after TBI in national and international health care.
| S-EPMC8199160 | biostudies-literature
Project description:ObjectivesImpairments after stroke may affect multiple domains of health-related quality of life (HRQoL). Patient-reported outcome measures (PROMs) have proven valuable in measuring patients' well-being. We examine the psychometric properties of a standard set of PROMs assessing global health, anxiety, and depression, and functioning in a German health care setting.MethodWe included inpatients at the Department of Neurology at the University Medical Center Hamburg-Eppendorf, diagnosed with stroke. Following the stroke-specific standard set of the International Consortium for Health Outcome Measurement, we collected demographic and clinical information at baseline, and PROMs for global health (PROMIS-10), three items for self-reported functioning, anxiety, and depression (PHQ-4) at 90 days follow-up. We calculated confirmatory factor analyses to test factorial validity and correlation analyses to test construct validity. We further conducted item and reliability analyses.ResultsIn a sample of 487 patients (mean age, SD: 71.1, 12.6; 47% female) with mild and moderate symptoms, model fit for the PROMIS-10 was acceptable for the two-factor and single-factor models. Factor loadings ranged from 0.52 to 0.94. The postulated single-factor model for functioning was saturated with zero degrees of freedom. Factor loadings ranged from 0.90 to 0.96. For the PHQ-4, the two-factor model showed excellent model fit. Factor loadings ranged from 0.78 to 0.87. Internal consistency was acceptable to good. Construct validity was generally confirmed.ConclusionsThe PROMIS-10 is a valid and reliable instrument to measure HRQoL among German stroke patients. While the PHQ-4 was confirmed as a screening measure for mental disorders, further research is needed on items assessing self-reported functioning. Results are limited to patients showing minimal functional deficits.
| S-EPMC8413767 | biostudies-literature
Project description: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)
| S-EPMC5888376 | biostudies-literature
Project description:There has been an increasing interest in patient-reported outcome (PRO) measures in both the clinical and research settings to improve the quality of life among patients and to identify when clinical intervention may be needed. The primary purpose of this prospective study was to validate an acute breast skin toxicity PRO measure across a broad sample of patient body types undergoing radiation therapy. Between August 2018 and September 2019, 134 women undergoing adjuvant breast radiotherapy (RT) consented to completing serial PRO measures both during and post-RT treatment and to having their skin assessed by trained trial radiation therapists. There was high patient compliance, with 124 patients (92.5%) returning to the clinic post-RT for at least one staff skin assessment. Rates of moist desquamation (MD) in the infra-mammary fold (IMF) by PRO were compared with skin assessments completed by trial radiation therapists. There was high sensitivity (86.5%) and good specificity (79.4%) between PRO and staff-reported presence of MD in the IMF, and there was a moderate correlation between the peak severity of the MD reported by PRO and assessed by staff (rho = 0.61, p < 0.001). This prospective study validates a new PRO measure to monitor the presence of MD in the IMF among women receiving breast RT.
| S-EPMC9325227 | biostudies-literature
Project description:BackgroundCancer patients can experience a number of reproductive complications as a result of cancer treatment and may benefit from reproductive preventative health strategies. A Reproductive Survivorship Patient Reported Outcome Measure (RS-PROM) is not currently available but could assist patients address reproductive concerns.PurposeTo develop and test the acceptability, feasibility and appropriateness of a RS-PROM tool to be used to assess reproductive needs of cancer survivors aged 18-45 years.MethodsWe reviewed the outcomes of a recently published audit of reproductive care provided in our cancer survivorship clinic to identify gaps in current service provided and used this along with available validated reproductive measures, to develop this pilot RS-PROM. Survivors aged 18-45 years either attending the SCH survivorship clinic over a 1-year period or participants on the Australasian Oncofertility Registry (AOFR) who had agreed to be contacted for future research studies were asked to complete the RS-PROM and a questionnaire on the acceptability, feasibility and appropriateness of content included.ResultsOne-hundred and fifty patients participated (61.3% females). Median age at cancer diagnosis was 24.5 years (range: 2-45 years). Eighty percent of participants reported the length of the RS-PROM was "just right", 92% agreed they would not mind completing the RS-PROM and 92.7% were willing to answer all questions, with 97% agreeing that the RS-PROM would be an important tool in addressing difficult sexual/reproductive topics concerning with healthcare professionals.ConclusionThe large majority of survivors participating in our pilot study found the RS-PROM to be an acceptable, feasible and useful tool to assist discussions of their sexual and reproductive health concerns and experiences with their clinical team.
| S-EPMC8396734 | biostudies-literature
Project description:BackgroundVarious patient reported outcome measures (PROMs) are used in idiopathic pulmonary fibrosis (IPF). We aimed to describe their psychometric properties, assess their relationship with 1-year mortality and determine their minimal clinically important differences (MCIDs).MethodsIn a prospective multicentre study, participants with IPF completed the King's Brief Interstitial Lung Disease Questionnaire (K-BILD), the modified Medical Research Council (mMRC) dyspnoea scale, St George's Respiratory Questionnaire (SGRQ) and University of California, San Diego shortness of breath questionnaire (UCSD-SOBQ) three-monthly intervals over a 12-month period. Forced vital capacity (FVC) was matched with questionnaires and mortality was captured. Anchor- and distribution-based methods were used to derive MCID.ResultsData were available from 238 participants. All PROMs had good internal consistency and high degree of correlations with other tools (except UCSD-SOBQ correlated poorly with FVC). There were significant associations with mortality for K-BILD (hazard ratio 16.67; 95% CI 2.38-100) and SGRQ (hazard ratio 4.65; 95% CI 1.32-16.62) but not with the other PROMs or FVC. The median MCID (range) for K-BILD was 6.3 (4.1-7.0), SGRQ was 7.0 (3.8-9.6), mMRC was 0.4 (0.1-0.5) and UCSD-SOBQ was 9.6 (4.1-14.2).ConclusionsThe K-BILD was related to other severity measures and had the strongest relationship with mortality.
| S-EPMC8495510 | biostudies-literature
Project description:Due to a lack of an appropriate disease-specific patient-reported outcome (PRO) instrument for chronic heart failure including its social support and treatment aspects in China, this study was performed to develop a patient-reported outcome measure (PROM) for patients with chronic heart failure and evaluate its reliability, validity, and feasibility.According to the standard PROM guidelines established by the Food and Drug Administration, an item pool was formed by reviewing a large amount of relevant literature and interviewing patients with chronic heart failure about their main symptoms. Thus, the primary scale was created after adjusting the items and language with the help of patients and experts in the field. Next, 155 patients from 8 hospitals in different districts were recruited for a pilot survey using questionnaires containing these items. The patients' responses were analyzed using the classical test theory and item response theory to select high-quality items and determine the subdomains of the scale. This was followed by a formal investigation in the same eight hospitals. In total, 360 patients and 100 healthy subjects were included to evaluate the reliability, validity, and feasibility of the items. Through this process, the final scale was established.The final scale comprised 12 subdomains with 57 items related to physical, psychological, social, and therapeutic areas. The data analysis results of the formal investigation showed that the PROM for chronic heart failure had good reliability, validity, and feasibility. Reliability was verified by Cronbach's alpha coefficient, which was 0.913 for the total scale, 0.903 for the physical domain, 0.941 for the psychological domain, 0.827 for the social domain, and 0.839 for the therapeutic domain. The construct validity results met the relative criteria of confirmatory factor analysis. Discriminant validity was represented by score comparisons of nine subdomains. The response rate and the effective rate of return of the CHF-PROM were 98.94% and 98.92%, respectively.The final scale coincides with the theoretical framework and better reflects the overall quality of life of patients with chronic heart failure. This scale can be used as a valid instrument to evaluate clinical treatment and clinical trials of chronic heart failure.
| S-EPMC5859646 | biostudies-literature
Project description:IntroductionThis analysis assessed the psychometric properties of the Psoriasis Symptoms and Impacts Measure (P-SIM), a novel patient-reported outcome (PRO) tool designed to capture patient experiences of the signs, symptoms and impacts of psoriasis.MethodsBlinded data from the BE RADIANT phase 3b trial of bimekizumab were analysed. In BE RADIANT, patients were randomised 1:1 to bimekizumab 320 mg every 4 weeks (Q4W) or secukinumab 300 mg (weekly until Week 4, then Q4W). Three items (itching, skin pain and scaling) of the P-SIM were electronically assessed throughout the trial and were scored from 0 to 10 (none to very severe signs/symptoms/impacts). Test-retest reliability was determined using intraclass correlations. Convergent validity was assessed between P-SIM and other relevant PRO and clinician-reported outcome (ClinRO) scores. Known-groups validity was assessed by comparing mean P-SIM item scores between patient subgroups based on the Psoriasis Area and Severity Index (PASI)/Investigator's Global Assessment (IGA) scores. Responsiveness was assessed via correlations between changes from baseline in P-SIM item scores and other relevant PRO and ClinRO scores. Anchor-based responder analyses and empirical cumulative distribution function (eCDF) curves determined responder thresholds.ResultsThe three P-SIM items yielded high intraclass coefficients (> 0.70). By Week 48, the three P-SIM items had moderate (> 0.30 and ≤ 0.50) to strong (> 0.50) correlations with other PROs and weaker correlations with ClinROs, demonstrating good convergent validity. For almost all known-group comparisons, statistically significant between-subgroup score differences were seen across all three P-SIM items. Changes from baseline in the P-SIM and other relevant outcomes were above the acceptable threshold of ≤ 0.30, demonstrating sensitivity to change. Anchor-based analyses determined a ≥ four-point reduction from baseline to indicate marked clinically meaningful improvement for the P-SIM.ConclusionThese results support the validity, reliability and sensitivity to change of the P-SIM in assessing key symptoms (itching, skin pain and scaling) in patients with moderate to severe plaque psoriasis.Trial registrationNCT03536884.
| S-EPMC8478739 | biostudies-literature
Project description:Background Validity is the ability of an instrument to measure what it claims to measure. It means the degree to which the empirical evidence supports the trustworthiness of interpretations based on the calculated scores. The hematological malignancy (HM) specific patient reported outcome measure (HM-PRO), is a newly developed instrument for use in daily clinical practice as well as in research. This study, provides the evidence for construct validity of the HM-PRO, specifically focusing on the convergent and divergent validity compared to the other established instruments used in hematology. Methods This validation study adopted a prospective cross-sectional design where a heterogeneous group of patients diagnosed with different HMs and different disease state were recruited. A total of 905 patients were recruited from seven secondary care hospitals in the UK and online through five patient organizations. Patients were asked to complete the HM-PRO and other cancer specific PRO’s, FACT-G and EORTC QLQ C-30. Data analysis was performed using IBM SPSS 23 statistical software. Results A total of 486 males (53.7%) and 419 females (46.3%), with a mean age of 64.3 (± 12.4) years and mean time since diagnosis of 4.6 ( ± 5.2) were recruited. The total score of Part A of the HM-PRO highly correlated with the five functional scales of the EORTC QLQ-C30 (Physical = ?0.71, Role = ?0.72, Emotional = ?0.64, Cognitive = ?0.58, Social = ?0.74—p < 0.001). With respect to correlation with FACT-G, the total score of Part A of the HM-PRO highly correlated with Physical (?0.74), Emotional (?0.57), Functional (?0.66) domains and overall score of FACT-G (?0.74). Similarly, the total score of Part B of the HM-PRO highly correlated with three symptoms scales of EORTC QLQ-C30 (Fatigue scale = ?0.74, Nausea and Vomiting = ?0.52, Pain = ?0.59—p < 0.001) and individual symptom items (Dyspnea = 0.51, Insomnia= 0.43, Appetite loss = 0.54—p < 0.001). Conclusion The construct validity evidence presented in this research is a testimony to the HM-PRO’s ability to measure HRQoL issues which it intends to measure. This is of utmost importance when a PRO is used in routine clinical practice so that the interpretation of the scores or response to an individual item is understood by the clinicians/nurses as intended by the patients.
| S-EPMC7506039 | biostudies-literature
Project description:BACKGROUND:In the past years, a mobile health (mHealth) app called the Dutch Talking Touch Screen Questionnaire (DTTSQ) was developed in The Netherlands. The aim of development was to enable Dutch physical therapy patients to autonomously complete a health-related questionnaire regardless of their level of literacy and digital skills. OBJECTIVE:The aim of this study was to evaluate the usability (defined as the effectiveness, efficiency, and satisfaction) of the prototype of the DTTSQ for Dutch physical therapy patients with diverse levels of experience in using mobile technology. METHODS:The qualitative Three-Step Test-Interview method, including both think-aloud and retrospective probing techniques, was used to gain insight into the usability of the DTTSQ. A total of 24 physical therapy patients were included. The interview data were analyzed using a thematic content analysis approach aimed at analyzing the accuracy and completeness with which participants completed the questionnaire (effectiveness), the time it took the participants to complete the questionnaire (efficiency), and the extent to which the participants were satisfied with the ease of use of the questionnaire (satisfaction). The problems encountered by the participants in this study were given a severity rating that was used to provide a rough estimate of the need for additional usability efforts. RESULTS:All participants within this study were very satisfied with the ease of use of the DTTSQ. Overall, 9 participants stated that the usability of the app exceeded their expectations. The group of 4 average-/high-experienced participants encountered only 1 problem in total, whereas the 11 little-experienced participants encountered an average of 2 problems per person and the 9 inexperienced participants an average of 3 problems per person. A total of 13 different kind of problems were found during this study. Of these problems, 4 need to be addressed before the DTTSQ will be released because they have the potential to negatively influence future usage of the tool. The other 9 problems were less likely to influence future usage of the tool substantially. CONCLUSIONS:The usability of the DTTSQ needs to be improved before it can be released. No problems were found with satisfaction or efficiency during the usability test. The effectiveness needs to be improved by (1) making it easier to navigate through screens without the possibility of accidentally skipping one, (2) enabling the possibility to insert an answer by tapping on the text underneath a photograph instead of just touching the photograph itself, and (3) making it easier to correct wrong answers. This study shows the importance of including less skilled participants in a usability study when striving for inclusive design and the importance of measuring not just satisfaction but also efficiency and effectiveness during such studies.
| S-EPMC6789421 | biostudies-literature