Validation of the Thai version of the family reported outcome measure (FROM-16)© to assess the impact of disease on the partner or family members of patients with cancer.
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ABSTRACT:
SUBMITTER: Chantarasap P
PROVIDER: S-EPMC6368697 | biostudies-literature | 2019 Feb
REPOSITORIES: biostudies-literature
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Validation of the Thai version of the family reported outcome measure (FROM-16)© to assess the impact of disease on the partner or family members of patients with cancer.
Chantarasap Pattariya P Johns Nutjaree Pratheepawanit NP Pairojkul Srivieng S Sookprasert Aumkhae A Wirasorn Kosin K Cheawchanwattana Areewan A Salek Sam S Subongkot Suphat S
Health and quality of life outcomes 20190208 1
<h4>Background</h4>Cancer not only impairs a patient's physical and psychosocial functional behaviour, but also contributes to negative impact on family members' health related quality of life. Currently, there is an absence of a relevant tool in Thai with which to measure such impact. The aim of this study was to translate and validate the Family Reported Outcome Measure (FROM-16) in Thai cancer patients' family members.<h4>Methods</h4>Thai version of FROM-16 was generated by interactive forwar ...[more]
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Project description:BackgroundThe Family Reported Outcome Measure (FROM-16) assesses the impact of a patient's chronic illness on the quality of life (QoL) of the patient's partner or family members. The aim of the study was to translate, explore the structure of and validate the FROM-16.MethodsThe questionnaire was translated from English into German (forward, backward, four independent translators). Six interviews with family members were conducted to confirm the questionnaire for linguistic, conceptual, semantic and experiential equivalence and its practicability. The final German translation was tested for internal consistency, reproducibility and test validity. Criterion validity was tested by correlating the scores of the FROM-16 and the Global Health Scale (GHS). Principal component analysis, factor analysis, and confirmatory factor analysis was used to assess the questionnaire's structure and its domains. Reliability and reproducibility were tested computing the intraclass correlation coefficient (ICC) using one sample t-test for testing the hypothesis that the difference between the scores was not different from zero.ResultsOverall, 83 family members (61% female, median age: 61 years) completed the questionnaire at two different times (mean interval: 22 days). Internal consistency was good for the FROM-16 scores (Cronbach's α for total score = 0.86). In those with stable GHS, the ICC for the total score was 0.87 and the difference was not different from zero (p = 0.262) indicating reproducible results. A bi-factor model with a general factor including all items, and two sub-factors comprising the items from the original 2-factor construct had the best fit.ConclusionsThe German FROM-16 has good reliability, test validity and practicability. It can be considered as an appropriate and generic tool to measure QoL of a patient's partner or family member. Due to the presence of several cross-loadings we do not recommend the reporting of the scores of the two domains proposed for the original version of FROM-16 when using the German version. Thus, in reporting the results emphasis should be put on the total score.Trial registrationRetrospectively registered: DRKS00021070.
| S-EPMC7992821 | biostudies-literature
Project description:BackgroundThe FROM-16 is a generic family quality of life (QoL) instrument that measures the QoL impact of patients' disease on their family members/partners. The study aimed to assess the responsiveness of FROM-16 to change and determine Minimal Important Change (MIC).MethodsResponsiveness and MIC for FROM-16 were assessed prospectively with patients and their family members recruited from outpatient departments of the University Hospital Wales and University Hospital Llandough, Cardiff, United Kingdom. Patients completed the EQ-5D-3L and a global severity question (GSQ) online at baseline and at 3-month follow-up. Family members completed FROM-16 at baseline and a Global Rating of Change (GRC) in addition to FROM-16 at follow-up. Responsiveness was assessed using the distribution-based (effect size-ES, standardized response mean -SRM) and anchor-based (area under the receiver operating characteristics curve ROC-AUC) approaches and by testing hypotheses on expected correlation strength between FROM-16 change score and patient assessment tools (GSQ and EQ-5D). Cohen's criteria were used for assessing ES. The AUC ≥ 0.7 was considered a good measure of responsiveness. MIC was calculated using anchor-based (ROC analysis and adjusted predictive modelling) and distribution methods based on standard deviation (SD) and standard error of the measurement (SEM).ResultsEighty-three patients with 15 different health conditions and their relatives completed baseline and follow-up questionnaires and were included in the responsiveness analysis. The mean FROM-16 change over 3 months = 1.43 (SD = 4.98). The mean patient EQ-5D change over 3 months = -0.059 (SD = 0.14). The responsiveness analysis showed that the FROM-16 was responsive to change (ES = 0.2, SRM = 0.3; p < 0.01). The ES and SRM of FROM-16 change score ranged from small (ES = 0.2; SRM = 0.3) for the distribution-based method to large (ES = 0.8, SRM = 0.85) for anchor-based methods. The AUC value was above 0.7, indicating good responsiveness. There was a significant positive correlation between the FROM-16 change scores and the patient's disease severity change scores (p < 0.001). The MIC analysis was based on data from 100 family members of 100 patients. The MIC value of 4 was suggested for FROM-16.ConclusionsThe results of this study confirm the longitudinal validity of FROM-16 which refers to the degree to which an instrument is able to measure change in the construct to be measured. The results yield a MIC value of 4 for FROM-16. These psychometric attributes of the FROM-16 instrument are useful in both clinical research as well as clinical practice.
| S-EPMC10965873 | biostudies-literature
Project description:PurposeFor patients with celiac disease (CeD), the only current management option is adherence to a strict gluten-free diet (GFD); however, many patients on a GFD continue to experience symptoms with a significant impact on quality of life. Potential new treatments for CeD are under development and a validated patient-reported outcome measure is required to evaluate their utility in clinical trials. The purpose of this article is to provide a history of the development of the Celiac Disease Symptom Diary (CDSD) 2.1© for use in clinical trials.MethodsQualitative and quantitative studies were conducted from 2010 to 2021, including concept elicitation and cognitive debriefing interviews with adult and adolescent participants with CeD (N = 93) diagnosed via biopsy and/or serology and input from eight interviews with CeD clinical experts. During these studies, different iterations of the CDSD were presented to the US Food and Drug Administration and the European Medicines Agency, and modifications were made in line with their feedback.ResultsThese studies ultimately led to the development of CDSD 2.1©, a daily diary which focuses on key symptoms of CeD (abdominal pain, bloating, diarrhea, nausea and tiredness). This patient-reported outcome measure was readily understood by adult and adolescent participants with CeD and content validity was demonstrated in both populations.ConclusionCDSD 2.1© is a content-valid patient-reported outcome measure developed in accordance with best practices and regulatory guidance. A thorough exploration of the psychometric properties of CDSD 2.1© for both adult and adolescent participants with CeD is ongoing to support utilization in clinical trials.
| S-EPMC11599373 | biostudies-literature
Project description:ObjectiveAlthough decision scientists and health economists encourage inclusion of family member/informal carer utility in health economic evaluation, there is a lack of suitable utility measures comparable to patient utility measures such those based on the EQ-5D. This study aims to predict EQ-5D-3L utility values from Family Reported Outcome Measure (FROM-16) scores, to allow the use of FROM-16 data in health economic evaluation when EQ-5D data is not available.MethodsData from 4228 family members/partners of patients recruited to an online cross-sectional study through 58 UK-based patient support groups, three research support platforms and Welsh social services departments were randomly divided five times into two groups, to derive and test a mapping model. Split-half cross-validation was employed, resulting in a total of ten multinomial logistic regression models. The Monte Carlo simulation procedure was used to generate predicted EQ-5D-3L responses, and utility scores were calculated and compared against observed values. Mean error and mean absolute error were calculated for all ten validation models. The final model algorithm was derived using the entire sample.ResultsThe model was highly predictive, and its repeated fitting using multinomial logistic regression demonstrated a stable model. The mean differences between predicted and observed health utility estimates ranged from 0.005 to 0.029 across the ten modelling exercises, with an average overall difference of 0.015 (a 2.2% overestimate, not of clinical importance).ConclusionsThe algorithm developed will enable researchers and decision scientists to calculate EQ-5D health utility estimates from FROM-16 scores, thus allowing the inclusion of the family impact of disease in health economic evaluation of medical interventions when EQ-5D data is not available.
| S-EPMC10973087 | biostudies-literature
Project description:ObjectiveTo assign clinical meanings to the Family Reported Outcome Measure (FROM-16) scores through the development of score bands using the anchor-based approach.Design and settingA cross-sectional online study recruited participants through UK-based patient support groups, research support platforms (HealthWise Wales, Autism Research Centre-Cambridge University database, Join Dementia Research) and through social service departments in Wales.ParticipantsFamily members/partners (aged ≥18 years) of patients with different health conditions.InterventionFamily members/partners of patients completed the FROM-16 questionnaire and a Global Question (GQ).Main outcome measureVarious FROM-16 band sets were devised as a result of mapping of mean, median and mode of the GQ scores to FROM-16 total score, and receiver operating characteristic-area under the curve cut-off values. The band set with the best agreement with GQ based on weighted kappa was selected.ResultsA total of 4413 family members/partners (male=1533, 34.7%; female=2858, 64.8%; Prefer not to say=16, 0.4%; other=6, 0.14%) of people with a health condition (male=1994, 45.2%; female=2400, 54.4%; Prefer not to say=12, 0.3%; other=7, 0.16%) completed the online survey: mean FROM-16 score=15.02 (range 0-32, SD=8.08), mean GQ score=2.32 (range 0-4, SD=1.08). The proposed FROM-16 score bandings are: 0-1=no effect on the quality of life of family member; 2-8=small effect on family member; 9-16=moderate effect on family member; 17-25=very large effect on family member; 26-32=extremely large effect on family member (weighted kappa=0.60).ConclusionThe FROM-16 score descriptor bands provide new information to clinicians about interpreting scores and score changes, allowing better-informed treatment decisions for patients and their families. The score banding of FROM-16, along with a short administration time, demonstrates its potential to support holistic clinical practice.
| S-EPMC10040025 | biostudies-literature
Project description:BackgroundPerinatal quality improvement lacks valid tools to measure adverse hospital experiences disproportionately impacting Black mothers and birthing people. Measuring and mitigating harm requires using a framework that centers the lived experiences of Black birthing people in evaluating inequitable care, namely, obstetric racism. We sought to develop a valid patient-reported experience measure (PREM) of Obstetric Racism© in hospital-based intrapartum care designed for, by, and with Black women as patient, community, and content experts.MethodsPROMIS© instrument development standards adapted with cultural rigor methodology. Phase 1 included item pool generation, modified Delphi method, and cognitive interviews. Phase 2 evaluated the item pool using factor analysis and item response theory.ResultsItems were identified or written to cover 7 previously identified theoretical domains. 806 Black mothers and birthing people completed the pilot test. Factor analysis concluded a 3 factor structure with good fit indices (CFI = 0.931-0.977, RMSEA = 0.087-0.10, R2 > .3, residual correlation < 0.15). All items in each factor fit the IRT model and were able to be calibrated. Factor 1, "Humanity," had 31 items measuring experiences of safety and accountability, autonomy, communication, and empathy. A 12-item short form was created to ease respondent burden. Factor 2, "Racism," had 12 items measuring experiences of neglect and mistreatment. Factor 3, "Kinship," had 7 items measuring hospital denial and disruption of relationships between Black mothers and their child or support system.ConclusionsThe PREM-OB Scale™ suite is a valid tool to characterize and quantify obstetric racism for use in perinatal improvement initiatives.
| S-EPMC9544169 | biostudies-literature
Project description:Aims and objectivesTo test the ability of the Reported Edmonton Frail Scale-Thai version to predict hospital outcomes compared with standard preoperative assessment measures (American Society of Anesthesiologists physical status classification and the Elixhauser Comorbidity Measure) in older Thai orthopaedic patients.BackgroundFrailty is a common geriatric condition. No previous studies have assessed frailty among orthopaedic patients in Thailand. Effective frailty screening could enhance quality of care.DesignProspective cohort study in a university hospital.MethodsTwo hundred hospitalised patients, aged 60 years or older and scheduled for orthopaedic surgery, participated in the study. Frailty was evaluated using the Reported Edmonton Frail Scale-Thai version. Multiple Firth logistic regression was used to model the effect of frailty on postoperative complications, postoperative delirium and discharge disposition. Length of stay was examined using Poisson regression. Comparing predictability of the instruments, the area under the receiver operating characteristic curve and mean squared errors were evaluated. The STROBE guideline was used.ResultsParticipants' mean age was 72 years; mostly were female, frail and underwent knee, spine and/or hip surgery. Poor health outcomes including postoperative complications, postoperative delirium, and not being discharged to the home were commonly identified. The length of stay varied from three days to more than ten weeks. Frailty was significantly associated with postoperative complications, postoperative delirium and prolonged length of stay. The Reported Edmonton Frail Scale-Thai version revealed good performance for predicting postoperative complications and postoperative delirium and was improved by combining with standard assessments.ConclusionThe Reported Edmonton Frail Scale-Thai version, alone or combined with standard assessment, was useful for predicting adverse outcomes in older adults undergoing orthopaedic surgery.Relevance to clinical practiceThese findings indicate that nurse professionals should apply culturally sensitive frailty screening to proactively identify patients' risk of frailty, improve care quality and prevent adverse outcomes.
| S-EPMC7756727 | biostudies-literature
Project description:β-Thalassemia, a hereditary blood disorder caused by reduced or absent synthesis of the β-globin chain of hemoglobin, is characterized by ineffective erythropoiesis, and can manifest as nontransfusion-dependent thalassemia (NTDT) or transfusion-dependent thalassemia (TDT). Many patients with NTDT develop a wide range of serious complications that affect survival and quality of life (QoL). Patient-reported outcomes (PRO), including health-related QoL (HRQoL), are important tools for determining patient health impairment and selecting appropriate treatment. However, there are currently no disease-specific PRO tools available to assess symptoms related to chronic anemia experienced by patients with NTDT. This study aimed to develop a new, US Food and Drug Administration (FDA)-compliant PRO of chronic anemia symptoms, the NTDT-PRO© tool, for use in patients with NTDT. Participants had a median age of 36 years (range, 18-47) and 60% were female. The initial development of the NTDT-PRO tool involved concept-elicitation interviews with 25 patients from 3 centers (in Lebanon, Greece, and Canada); subsequent interview discussions and clinical input resulted in the generation of 9 items for inclusion in the draft NTDT-PRO. Following a round of cognitive interviews involving 21 patients from 2 centers (in Lebanon and Greece), 4 items (Pain, Headaches, Ability to Concentrate, and Paleness) were removed from the draft NTDT-PRO. The final NTDT-PRO comprises 6 items that measure Tiredness, Weakness, and Shortness of Breath, with or without Physical Activity. The NTDT-PRO is a new disease-specific HRQoL tool for patients with NTDT, developed using a thorough methodology based on FDA 2009 PRO development guidelines.
| S-EPMC6587527 | biostudies-literature
Project description:This study demonstrates the quantitative characteristics of the first patient-reported outcome (PRO) tool developed for patients with nontransfusion-dependent β-thalassemia (NTDT), the NTDT-PRO© . A multicenter validation study was performed over 24 weeks, involving 48 patients from Italy, Lebanon, Greece, and Thailand. Most patients were female (68.8%), with a median age of 34.5 years (range, 18-52); 66.7% were diagnosed with β-thalassemia intermedia, and median time since diagnosis was 22 years (range, 0-43). The NTDT-PRO comprises 6 items across 2 domains (Tiredness/Weakness and Shortness of Breath [SoB]), and was valid and reliable, with good consistency. At baseline, most patients reported symptoms as present via the NTDT-PRO, and were highly compliant, ≥90% completing the NTDT-PRO tool. In a pairwise correlation analysis, all items were positively correlated. Correlations between NTDT-PRO and existing tools-36-Item Short Form Health Survey version 2 (SF-36v2) and Functional Assessment of Cancer Therapy-Anemia (FACT-An)-were assessed at weeks 1, 3, and 12; robust correlations were seen between SoB and SF-36v2-Vitality (rs = -0.53), and between SoB and Fact-An-Fatigue Experience (rs = -0.66) at week 1. Internal consistency was high for both Tiredness/Weakness (Cronbach alpha, 0.91) and SoB (Spearman-Brown coefficient, 0.78); intraclass correlation coefficients were high (Tiredness/Weakness, 0.88 and 0.97; SoB, 0.92 and 0.98), demonstrating stability. Further studies are required to fully support the validity of this tool, this study demonstrated the usefulness of the NTDT-PRO in the clinical setting and for longitudinal clinical research, particularly in trials where patient health-related quality of life is expected to change.
| S-EPMC6587834 | biostudies-literature
Project description:ObjectiveTo evaluate the psychometric properties of the Thai version of the Cancer Survivors' Unmet needs (CaSUN-TH) scale among Thai cancer survivors after completion of primary treatment.MethodsStandardized translation procedures developed the Cancer Survivors' Unmet Needs into a Thai version (CaSUN-TH). Face validity was evaluated by a group of experts, and a pilot test on 10 cancer patients was conducted to evaluate its readability. A total of 236 cancer survivors who were attending follow-up visits at a cancer hospital in Thailand completed the CaSUN-TH. The internal consistency of the instrument was examined using Cronbach's α. The association of the CaSUN-TH and its subscales with physical symptoms, QoL, age, gender, and type of cancer were examined for criterion validity and known-group validity. Construct validity was evaluated using confirmatory factor analysis.ResultsThe CaSUN-TH showed good readability and high content validity for use as an instrument to assess unmet needs among Thai cancer survivors. Cronbach's α for the entire scale was 0.95. Confirmatory factor analysis indicated that the five-factor structure of the CaSUN-TH was good fit to the data (CFI = 0.901, SRMR = 0.074, RMSEA = 0.076 [90% confidence interval, 0.066-0.085]). In terms of construct validity, CaSUN-TH scores significantly correlated to other variables hypothesized to influence the level of need, including higher physical symptoms prevalence was related to poor quality of life, and poorer QOL and younger age were associated with a higher level of unmet needs. In addition, the scale was able to differentiate scores between groups, including gender, age, and type of primary cancer, with theoretically hypothesized differences.ConclusionsThe CaSUN-TH demonstrated appropriate psychometric properties for assessing unmet needs in different cancer survivor groups in Thailand. Using the CaSUN-TH can help health professionals in targeting individual survivor needs, bridging the gap between patients' experiences and their expectations, and improving the quality of cancer survivorship care.
| S-EPMC9263872 | biostudies-literature