Psychometric properties of a prostate cancer radiation late toxicity questionnaire.
Ontology highlight
ABSTRACT:
SUBMITTER: Rodrigues G
PROVIDER: S-EPMC1894787 | biostudies-literature | 2007
REPOSITORIES: biostudies-literature
Publications
Psychometric properties of a prostate cancer radiation late toxicity questionnaire.
Rodrigues George G Bauman Glenn G Lock Michael M D'Souza David D Mahon Jeff J
Health and quality of life outcomes 20070531
<h4>Background</h4>To construct a short prostate cancer radiation late toxicity (PCRT) questionnaire with health-related quality-of-life (HRQoL) domains.<h4>Methods</h4>The PCRT was developed by item generation, questionnaire construction (n = 7 experts, n = 8 focus group patients), pilot testing (n = 37), item reduction (n = 100), reliability testing (n = 237), and validity testing (n = 274).<h4>Results</h4>Reliability of the three item-reduced subscales demonstrated intraclass correlation coef ...[more]
Similar Datasets
Project description:PurposeThe aims of this study were to systematically review tolerance doses for late distinct gastrointestinal (GI), genitourinary (GU), and sexual dysfunction (SD) symptoms after external beam radiation therapy (EBRT) alone and treatments involving brachytherapy (BT) for prostate cancer after Quantitative Analysis of Normal Tissue Effects in the Clinic (QUANTEC) and ultimately to perform quantitative syntheses of identified dose/volume tolerances represented by dose-volume histogram (DVH) thresholds, that is, statistically significant (P ≤ .05) cutoff points between symptomatic and asymptomatic patients in a certain study.Methods and materialsPubMed was scrutinized for full-text articles in English after QUANTEC (January 1, 2010). The inclusion criteria were randomized controlled trials, case-control studies, or cohort studies with tolerance doses for late distinct symptoms ≥3 months after primary radiation therapy for prostate cancer (N > 30). All DVH thresholds were converted into equivalent doses in 2-Gy fractions (EQD2α/β) and were fitted with a linear or linear-quadratic function (goodness of fit, R2). The review was registered on PROSPERO (CRD42016042464).ResultsFrom 33 identified studies, which included 36 to 746 patients per symptom domain, the majority of dose/volume tolerances were derived for GI toxicity after EBRT alone (GI, 97 thresholds; GU, 8 thresholds; SD, 1 threshold). For 5 symptoms (defecation urgency, diarrhea, fecal incontinence, proctitis, and rectal bleeding), relationships between dose/volume tolerances across studies (R2 = 0.93 [0.82-1.00]), and across symptoms, leading to a curve for overall GI toxicity (R2 = 0.98), could be determined. For these symptoms, mainly rectal thresholds were found throughout low and high doses (10 Gy ≤ equivalent dose in 2-Gy fractions using α/β = 3Gy (EQD23) ≤ 50 Gy and 55 Gy ≤ EQD23 ≤ 78 Gy, respectively). For BT with or without EBRT, dose/volume tolerances were also mainly identified for GI toxicity (GI, 14 thresholds; GU, 4 thresholds; SD, 2 thresholds) with the largest number of DVH thresholds concerning rectal bleeding (5 thresholds).ConclusionsUpdated dose/volume tolerances after QUANTEC were found for 17 GI, GU, or SD symptoms. A DVH curve described the relationship between dose/volume tolerances across 5 GI symptoms after EBRT alone. Restricting treatments for EBRT alone using the lower boundaries of this curve is likely to limit overall GI toxicity, but this should be explored prospectively. Dose/volume tolerances for GU and SD toxicity after EBRT alone and after BT with or without EBRT were scarce and support further research including data-sharing initiatives to untangle the dose/volume relationships for these symptoms.
| S-EPMC6652194 | biostudies-literature
Project description:PurposeTo report acute and late bowel, urinary, and sexual dysfunction patient-reported outcome measures, among patients with localized prostate cancer who underwent stereotactic magnetic resonance-guided daily adaptive radiation therapy (SMART).Methods and materialsAll patients who completed a baseline 12-item Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events questionnaire, before undergoing SMART with 36.25 Gy in 5 fractions, were subsequently followed up with the same graded questionnaire at set time points. Latest prostate-specific antigen levels were recorded. The percentage of patients who reported no change from their baseline adverse event (AE) or reported a new ≥ "frequent or almost constant" or "severe grade or higher" AE grade during follow-up was calculated. The maximum 12-item Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events grade for each item was recorded for each patient. The percentage of toxicity levels for each separate AE item at set time points was calculated.ResultsThe total number of patients was 69 with a median follow-up of 27 months. Median age of the cohort was 73 years (range, 54-85 years). The median pretreatment prostate-specific antigen level, T stage, and Gleason score were 7.5 mmol/L (range, 4.5-32 mmol/L), T2b (range, T2-T3b), and 7 (3 + 4; range, 6-9), respectively. No patient had biochemical failure during follow-up. Regarding bowel symptoms, >80% of men reported no change from baseline toxicity during follow-up. New ≥ frequent or almost constant diarrhea was reported in 9% of patients. "Almost constant" diarrhea peaked at 1 month but was absent at >33 months. Regarding urinary symptoms, increased urinary urgency was the most common complaint (39%). Twenty percent of men reported new ≥ frequent or almost constant urinary urgency incidence peaking at 1 month but absent at >33 months. New "severe" sexual dysfunction was seen in 26% of patients and was persistent at >33 months.ConclusionsOur study is one the largest patient-reported outcomes study after prostate SMART. It shows acceptable levels of toxicity even up to 2 years after treatment.
| S-EPMC11367053 | biostudies-literature
Project description:BackgroundTrust has been introduced as the cornerstone of the public and health providers' relation. Public trust in primary health care (PHC) is crucial and must be measured. The aim of this study was to develop and validate PHC trust measurement tool.MethodsThis was a psychometric study to develop PHC trust measuring tool done in Tabriz, East-Azerbaijan with participation of 600 households in 2016. Item generation was done through literature review and experts opinions. The content validity, reliability and construct validity of the PHC trust tool were assessed using several statistical methods including modified Kappa, Kendall's Tau and intra-class correlation coefficient (ICC) as well as exploratory factor analysis (EFA). Data were analyzed using STATA 14 statistical software package.ResultsA 30-item questionnaire was developed. The Modified Kappa coefficient as an indicator of content validity assessment was 0.94. With respect to reliability assessment, a high internal consistency was observed with 0.98 Cronbach-Alpha score and the test-retest reliability for overall scale (assessed by ICC) was 0.94 (CI: 0.87-0.97). Exploratory factor analysis emerged 2 factors. Factor 1 consisted of 25 items accounting for 74.1% of the variance (eigenvalue?=?22.47) followed by Factor 2 consisting of 5 items accounting for 19.2% of the variance (eigenvalue?=?1.6).ConclusionPHC trust measuring tool could be used as a valid and reliable tool by health systems in Iran and similar contexts to investigate how they are trustful from the public viewpoint.
| S-EPMC6642567 | biostudies-literature
Project description:Purpose: Severe late normal tissue damage limits radiotherapy treatment regimens. This study aims to validate γ-H2AX foci decay ratios and induced expression levels of DNA double strand break (DSB) repair genes, found in a retrospective study, as possible predictors for late radiation toxicity. Methods and Materials: Prospectively, decay ratios (initial/residual γ-H2AX foci numbers) and genome-wide expression profiles were examined in ex vivo irradiated lymphocytes of 198 prostate cancer patients. All patients were followed ≥2 years after radiotherapy, clinical characteristics were assembled and toxicity was recorded using the Common Terminology Criteria (CTCAE) v4.0. Results: No clinical factors were correlated with late radiation toxicity. Analysis of γ-H2AX foci uncovered a negative correlation between the foci decay ratio and toxicity grade. Significantly smaller decay ratios were found in grade≥3 compared to grade 0 patients (p=0.02), indicating less efficient DNA-DSB repair in radio-sensitive patients. Moreover, utilizing a foci decay ratio threshold determined in our previous retrospective study correctly classified 23 of the 28 grade≥3 patients (sensitivity, 82%) and 9 of the 14 grade 0 patients (specificity, 64%). Grade of toxicity also correlated with a reduced induction of the homologous recombination (HR) repair gene-set. The difference in average fold induction of the HR gene-set was most pronounced between grade 0 and grade≥3 patients (p=0.008). Conclusions: Reduced responsiveness of HR repair genes to irradiation and inefficient DSB repair correlate with an increased risk of late radiation toxicity. Using a decay ratio classifier, we could correctly classify 82% of the patients with grade≥3 toxicity. Additional studies are required to further optimize and validate the foci decay assay and to assess its predictive value for late radiation toxicity in patients prostate cancer
2017-01-30 | GSE85570 | GEO
Project description:PurposeThe aims of this cross-sectional study were to explore reliability and validity of the Norwegian version of the Patient-Reported Outcome Measurement System®-Profile 57 (PROMIS-57) questionnaire in a general population sample, n = 408, and to examine Item Response properties and factor structure.MethodsReliability measures were obtained from factor analysis and item response theory (IRT) methods. Correlations between PROMIS-57 and RAND-36-item health survey (RAND36) were examined for concurrent and discriminant validity. Factor structure and IRT assumptions were examined with factor analysis methods. IRT Item and model fit and graphic plots were inspected, and differential item functioning (DIF) for language, age, gender, and education level were examined.ResultsPROMIS-57 demonstrated excellent reliability and satisfactory concurrent and discriminant validity. Factor structure of seven domains was supported. IRT assumptions were met for unidimensionality, local independence, monotonicity, and invariance with no DIF of consequence for language or age groups. Estimated common variance (ECV) per domain and confirmatory factor analysis (CFA) model fit supported unidimensionality for all seven domains. The GRM IRT Model demonstrates acceptable model fit.ConclusionsThe psychometric properties and factor structure of Norwegian PROMIS-57 were satisfactory. Hence, the 57-item questionnaire along with PROMIS-29, and the corresponding 8 and 4 item short forms for physical function, anxiety, depression, fatigue, sleep disturbance, social participation ability and pain interference, are considered suitable for use in research and clinical care in Norwegian populations. Further studies on longitudinal reliability and sensitivity in patient populations and for Norwegian item calibration and/or reference scores are needed.
| S-EPMC8800876 | biostudies-literature
Project description:ObjectivesThe Nurses Work Functioning Questionnaire (NWFQ) is a 50-item self-report questionnaire specifically developed for nurses and allied health professionals. Its seven subscales measure impairments in the work functioning due to common mental disorders. Aim of this study is to evaluate the psychometric properties of the NWFQ, by assessing reproducibility and construct validity.MethodsThe questionnaire was administered to 314 nurses and allied health professionals with a re-test in 112 subjects. Reproducibility was assessed by the intraclass correlations coefficients (ICC) and the standard error of measurement (SEM). For construct validity, correlations were calculated with a general work functioning scale, the Endicott Work Productivity Scale (EWPS) (convergent validity) and with a physical functioning scale (divergent validity). For discriminative validity, a Mann Whitney U test was performed testing for significant differences between subjects with mental health complaints and without.ResultsAll subscales showed good reliability (ICC: 0.72-0.86), except for one (ICC = 0.16). Convergent validity was good in six subscales, correlations ranged from 0.38-0.62. However, in one subscale the correlation with the EWPS was too low (0.22). Divergent validity was good in all subscales based on correlations ranged from (-0.06)-(-0.23). Discriminative validity was good in all subscales, based on significant differences between subjects with and without mental health complaints (p<0.001-p = 0.003).ConclusionThe NWFQ demonstrates good psychometric properties, for six of the seven subscales. Subscale "impaired decision making" needs improvement before further use.
| S-EPMC3210752 | biostudies-literature
Project description:Stereotactic body radiation therapy (SBRT) is a technically demanding prostate cancer treatment that may be less expensive than intensity-modulated radiation therapy (IMRT). Because SBRT may deliver a greater biologic dose of radiation than IMRT, toxicity could be increased. Studies comparing treatment cost to the Medicare program and toxicity are needed.We performed a retrospective study by using a national sample of Medicare beneficiaries age ? 66 years who received SBRT or IMRT as primary treatment for prostate cancer from 2008 to 2011. Each SBRT patient was matched to two IMRT patients with similar follow-up (6, 12, or 24 months). We calculated the cost of radiation therapy treatment to the Medicare program and toxicity as measured by Medicare claims; we used a random effects model to compare genitourinary (GU), GI, and other toxicity between matched patients.The study sample consisted of 1,335 SBRT patients matched to 2,670 IMRT patients. The mean treatment cost was $13,645 for SBRT versus $21,023 for IMRT. In the 6 months after treatment initiation, 15.6% of SBRT versus 12.6% of IMRT patients experienced GU toxicity (odds ratio [OR], 1.29; 95% CI, 1.05 to 1.53; P = .009). At 24 months after treatment initiation, 43.9% of SBRT versus 36.3% of IMRT patients had GU toxicity (OR, 1.38; 95% CI, 1.12 to 1.63; P = .001). The increase in GU toxicity was due to claims indicative of urethritis, urinary incontinence, and/or obstruction.Although SBRT was associated with lower treatment costs, there appears to be a greater rate of GU toxicity for patients undergoing SBRT compared with IMRT, and prospective correlation with randomized trials is needed.
| S-EPMC3986382 | biostudies-other
Project description:PURPOSE:Late genitourinary (GU) toxicity after radiation therapy limits the quality of life of prostate cancer survivors; however, efforts to explain GU toxicity using patient and dose information have remained unsuccessful. We identified patients with a greater congenital GU toxicity risk by identifying and integrating patterns in genome-wide single nucleotide polymorphisms (SNPs). METHODS AND MATERIALS:We applied a preconditioned random forest regression method for predicting risk from the genome-wide data to combine the effects of multiple SNPs and overcome the statistical power limitations of single-SNP analysis. We studied a cohort of 324 prostate cancer patients who were self-assessed for 4 urinary symptoms at 2 years after radiation therapy using the International Prostate Symptom Score. RESULTS:The predictive accuracy of the method varied across the symptoms. Only for the weak stream endpoint did it achieve a significant area under the curve of 0.70 (95% confidence interval 0.54-0.86; P = .01) on hold-out validation data that outperformed competing methods. Gene ontology analysis highlighted key biological processes, such as neurogenesis and ion transport, from the genes known to be important for urinary tract functions. CONCLUSIONS:We applied machine learning methods and bioinformatics tools to genome-wide data to predict and explain GU toxicity. Our approach enabled the design of a more powerful predictive model and the determination of plausible biomarkers and biological processes associated with GU toxicity.
| S-EPMC5886789 | biostudies-literature
Project description:ObjectivesAcceptance and action questionnaire (AAQ II) is a scale used to assess psychological inflexibility. The aim of this study is to translate AAQ II into Malay language and evaluate the psychometric properties of AAQ II Malay version.MethodsThe AAQ II which has been translated into Malay language via back translation procedure was distributed to 101 cancer patients and 100 non-cancer patients. The evaluation of psychometric properties in this study included content validity index, internal consistency, parallel reliability, exploratory factor analysis, concurrent validity, sensitivity and specificity of AAQ II Malay version.ResultsAAQ II Malay version has established good content validity index, acceptable internal consistency with Cronbach's alpha value of 0.91, excellent parallel reliability and adequate concurrent validity. Exploratory factor analysis (EFA) results demonstrated AAQ II Malay version is a unidimensional factor instrument. The result of sensitivity and specificity of AAQ II Malay version indicated cancer patients who scored more than 17.5 were having significant psychological inflexibility.ConclusionAAQ II Malay version is a reliable and valid instrument to measure psychological inflexibility among cancer patient in Malaysia.
| S-EPMC6391017 | biostudies-literature
Project description:ObjectiveThe aim of this systematic review was to summarise the psychometric properties of patient-reported outcome measures (PROMs) measuring financial toxicity (FT) in cancer survivors.DesignThis systematic review was conducted according to the guidance of the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology.Data sourcesComprehensive searches were performed in PubMed, MEDLINE, Embase, CINAHL, PsycINFO, Web of Science, ProQuest and Cochrane Library from database inception to February 2022.Eligibility criteria for selecting studiesWe included studies that reported any PROMs for measuring FT in cancer survivors who were ≥18 years old. FT was defined as perceived subjective financial distress resulting from objective financial burden. Studies that were not validation studies and that used a PROM only as an outcome measurement were excluded.Data extraction and synthesisTwo reviewers independently extracted data from the included papers. We used the COSMIN criteria to summarise and evaluate the psychometric properties of each study regarding structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, cross-cultural validity/measurement invariance, criterion validity and responsiveness.ResultsA total of 23 articles (21 PROMs) were eligible for inclusion in this study. The findings highlighted that the Comprehensive Score for Financial Toxicity (COST) had an adequate development process and showed better psychometric properties than other PROMs, especially in internal consistency (Cronbach's α=0.92), reliability (intraclass correlation coefficient=0.80) and hypothesis testing (r=0.42-0.20).ConclusionsFrom a psychometric property perspective, the COST could be recommended as the most suitable worldwide available measure for use in research and clinical practice across different contexts. We suggest that PROMs should be selected only after careful consideration of the local socioeconomic context. Future studies are warranted to develop various FT PROMs based on different social and cultural backgrounds and to clarify the theoretical grounds for assessing FT.
| S-EPMC9234804 | biostudies-literature