Validity of the French version of Catquest-9SF and use of an electronic notepad for entering patient-reported outcome measures.
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ABSTRACT: Background
The Catquest-9SF questionnaire is a patient reported outcome measure that quantifies the visual benefits from cataract surgery. The purpose of this study was to translate and adapt the Catquest-9SF questionnaire for France, to assess its psychometric properties via Rasch analysis, and to assess its validity when completed using an electronic notepad.Methods
The Catquest-9SF questionnaire was translated following the guidelines of the International Society for Pharmacoeconomics and Outcomes Research. Catquest-9SF and clinical data were collected from patients before and after routine cataract surgery. All questionnaire data were collected via an electronic notepad. Rasch analysis was performed to assess psychometric properties, and sensitivity to change was analysed for patients with complete paired pre- and post-operative questionnaires.Results
A complete filled-in preoperative questionnaire was obtained for 848 patients. Rasch analysis showed good precision (person separation: 2.32, person reliability: 0.84), ordered category probability curves, no item misfit, and unidimensionality. The respondents were slightly more able than the level of item difficulty (targeting: -1.12 logits). Sensitivity was analysed on 211 paired questionnaires, and the postoperative questionnaires showed a clear ceiling effect. The effect size was 2.6. The use of an electronic notepad for completing the questionnaire worked out very well after some adjustments.Conclusions
The French version of Catquest-9SF has good psychometric properties and is suitable for use in French-speaking patients. The use of the Catquest-9SF questionnaire in an electronic format showed good validity.
SUBMITTER: Katz G
PROVIDER: S-EPMC8015069 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ImportanceChemotherapy-induced peripheral neuropathy (CIPN) is a substantial adverse effect of anticancer treatments. As such, the assessment of CIPN remains critically important in both research and clinic settings.ObjectiveTo compare the validity of various patient-reported outcome measures (PROMs) with neurophysiological and sensory functional measures as the optimal method of CIPN assessment.Design, setting, and participantsThis cohort study evaluated participants treated with neurotoxic chemotherapy across 2 cohorts using a dual-study design. Participants commencing treatment were assessed prospectively at beginning of neurotoxic treatment, midtreatment, and at the end of treatment. Participants who completed treatment up to 5 years prior were assessed cross-sectionally and completed a single assessment time point. Participants were recruited from oncology centers in Australia from August 2015 to November 2022. Data analysis occurred from February to November 2023.ExposuresNeurotoxic cancer treatment including taxanes, platinums, vinca-alkaloids, proteasome inhibitors, and thalidomide.Main outcomes and measuresCIPN was assessed via PROMs (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-CIPN20], Functional Assessment of Cancer Therapy/Gynecological Cancer Group Neurotoxicity Questionnaire (FACT/GOG-Ntx), and the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE]), neurological and neurophysiological assessment (Total Neuropathy Score and sural and tibial compound nerve amplitudes), and sensory measures (Grating orientation, Von Frey monofilament, and 2-point discrimination tasks). Core measurement properties of CIPN outcome measures were evaluated. Convergent and known-groups validity was assessed cross-sectionally following treatment completion, and responsiveness was evaluated prospectively during treatment. Neurological, neurophysiological, and sensory outcome measure scores were compared between those who reported high and low levels of CIPN symptoms using linear regressions.ResultsA total of 1033 participants (median [IQR] age, 61 [50-59] years; 676 female [65.4%]) were recruited to this study, incorporating 1623 assessments. PROMs demonstrated best ability to accurately assess CIPN (convergent validity), especially the PRO-CTCAE composite score (r = 0.85; P < .001) and EORTC-CIPN20 (r = 0.79; P < .001). PROMS also demonstrated the best ability to discriminate between CIPN severity (known-groups validity) and to detect changes at onset of CIPN development (responsiveness), especially for EORTC-CIPN20 (d = 0.67; 95% CI, 0.52-0.83), FACT/GOG-Ntx (d = 0.65; 95% CI, 0.49-0.81) and the PRO-CTCAE (d = 0.83; 95% CI, 0.64-1.02). Other measures did not achieve threshold for convergent validity (α < 0.7). Neurophysiological and sensory measures did not demonstrate acceptable responsiveness. In regression models, neurological, neurophysiological, and sensory outcome measures were significantly impaired in participants who reported high levels of CIPN symptoms compared with those who reported low levels of CIPN symptoms.Conclusions and relevanceIn this cohort study of 1033 cancer patients, PROMs were the only measures to satisfy all 3 core measurement property criteria (convergent validity, known-groups validity, and responsiveness). These findings suggest that adoption of PROMs in clinical practice can equip clinicians with valuable information in assessing CIPN morbidity.
| S-EPMC11316238 | biostudies-literature
Project description:BackgroundWith the rise of digital health technologies and telemedicine, the need for evidence-based evaluation is growing. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are recommended as an essential part of the evaluation of telemedicine. For the first time, a systematic review has been conducted to investigate the use of PROMs and PREMs in the evaluation studies of telemedicine covering all application types and medical purposes.ObjectiveThis study investigates the following research questions: in which scenarios are PROMs and PREMs collected for evaluation purposes, which PROM and PREM outcome domains have been covered and how often, which outcome measurement instruments have been used and how often, does the selection and quantity of PROMs and PREMs differ between study types and application types, and has the use of PROMs and PREMs changed over time.MethodsWe conducted a systematic literature search of the MEDLINE and Embase databases and included studies published from inception until April 2, 2020. We included studies evaluating telemedicine with patients as the main users; these studies reported PROMs and PREMs within randomized controlled trials, controlled trials, noncontrolled trials, and feasibility trials in English and German.ResultsOf the identified 2671 studies, 303 (11.34%) were included; of the 303 studies, 67 (22.1%) were feasibility studies, 70 (23.1%) were noncontrolled trials, 20 (6.6%) were controlled trials, and 146 (48.2%) were randomized controlled trials. Health-related quality of life (n=310; mean 1.02, SD 1.05), emotional function (n=244; mean 0.81, SD 1.18), and adherence (n=103; mean 0.34, SD 0.53) were the most frequently assessed outcome domains. Self-developed PROMs were used in 21.4% (65/303) of the studies, and self-developed PREMs were used in 22.3% (68/303). PROMs (n=884) were assessed more frequently than PREMs (n=234). As the evidence level of the studies increased, the number of PROMs also increased (τ=-0.45), and the number of PREMs decreased (τ=0.35). Since 2000, not only has the number of studies using PROMs and PREMs increased, but the level of evidence and the number of outcome measurement instruments used have also increased, with the number of PREMs permanently remaining at a lower level.ConclusionsThere have been increasingly more studies, particularly high-evidence studies, which use PROMs and PREMs to evaluate telemedicine. PROMs have been used more frequently than PREMs. With the increasing maturity stage of telemedicine applications and higher evidence level, the use of PROMs increased in line with the recommendations of evaluation guidelines. Health-related quality of life and emotional function were measured in almost all the studies. Simultaneously, health literacy as a precondition for using the application adequately, alongside proper training and guidance, has rarely been reported. Further efforts should be pursued to standardize PROM and PREM collection in evaluation studies of telemedicine.
| S-EPMC8663685 | biostudies-literature
Project description:BACKGROUND:Mobile health (mHealth) technologies are increasingly used in various medical fields. However, the potential of mHealth to improve patient care in radiotherapy by acquiring electronic patient reported outcome measures (ePROMs) during treatment has been poorly studied so far. OBJECTIVE:The aim of this study was to develop and implement a novel Web app (PROMetheus) for patients undergoing radiotherapy. Herein, we have reported our experience with a focus on feasibility, patient acceptance, and a correlation of ePROMs with the clinical course of the patients. METHODS:In the period between January and June 2018, 21 patients used PROMetheus to score side effects, symptoms, and quality of life-related parameters during and after their treatment. Items of the Patient Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) were chosen based on the primary site of disease, 27 items for head and neck tumors, 21 items for thoracic tumors, and 24 items for pelvic tumors. RESULTS:In total, 17 out of the 21 patients (81%) regularly submitted ePROMs and more than 2500 data points were acquired. An average of 5.2, 3.5, and 3.3 min was required to complete the head and neck, thorax, and pelvis questionnaires, respectively. ePROMS were able to detect the occurrence of both expected and unexpected side effects during the treatment. In addition, a gradual increase in the severity of side effects over the course the treatment and their remission afterward could be observed with ePROMs. In total, 9 out of the 17 patients (53%), mostly those with head and neck and thoracic cancers, reported PRO-CTCAE grade III or IV fatigue with severe impairments of activities of daily life. CONCLUSIONS:This study shows the successful implementation of an ePROM system and a high patient acceptance. ePROMs have a great potential to improve patient care in radiotherapy by providing a comprehensive documentation of symptoms and side effects, especially of ones that are otherwise underreported.
| S-EPMC6685133 | biostudies-literature
Project description:BackgroundMost antithrombotic medication users are older adults. Patient-reported outcome measures are commonly used in clinical research on antithrombotic medication, such as the diagnosis of intracranial hemorrhage.ObjectivesTo determine the reliability of patient-reported intracranial hemorrhage, anticoagulant and platelet aggregation inhibitor use in the older adult population.Patients/methodsWe conducted a secondary analysis of a prospective, observational cohort study of older adults who presented to the emergency department with a fall. The primary outcome was diagnosis of intracranial bleeding. We compared patient-reported intracranial bleeding to structured chart review with adjudication. We also compared patient-reported use of antiplatelet and anticoagulant medication to physician-reported medication use supplemented with structured chart review. We calculated the diagnostic accuracy of the patient-reported outcomes using our comparators as the reference standard.ResultsExact agreement for patient-reported intracranial bleeds was 95%, with a Cohen's kappa of 0.30 (95% confidence interval [CI], 0.15-0.45). The sensitivity was 36.7% (95% CI, 20.6%-56.1%) and specificity 97.2% (95% CI, 95.8%-98.1%). For anticoagulant medication use, exact agreement was 87%, Cohen's kappa 0.66 (95% CI, 0.63-0.72), sensitivity 84.0% (95% CI, 79.3%-83.8%), and specificity 87.6% (95% CI, 85.1%-89.7%). For antiplatelet medication use, exact agreement was 77%, Cohen's kappa 0.50 (95% CI, 0.44-0.55), sensitivity 68.7% (95% CI, 64.0%-73.1%), and specificity 81.2% (95% CI, 78.0-83.8%).ConclusionsPatient-reported outcome and exposure data were unreliable in this study. Our findings have a bearing on future research study design.
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Project description:Surgical procedures incorporating a cosmetic element such as septorhinoplasty and otoplasty are currently under threat in the National Health Service (NHS) as they are deemed to be procedures of 'limited clinical benefit' by many primary care providers. Patient reported outcome measures (PROMs), which assess the quality of care delivered from the patients' perspective, are becoming increasingly important in documenting the effectiveness of such procedures.The Rhinoplasty Outcomes Evaluation (ROE) questionnaire, a validated PROM tool, was used to assess patient satisfaction in 141 patients undergoing septorhinoplasty surgery over a 90-month period at the University Hospital Southampton NHS Foundation Trust.Overall, 100 patients with a mean follow-up period of 36 months completed the study. The mean ROE score was 73.3%. In addition, 75% of patients questioned were happy with the final result of their operation and 83% would undergo the procedure again if required. These benefits occurred irrespective of age, sex and primary versus revision surgery, and were maintained for up to 71 months following surgery.This study has shown that patients are generally satisfied with their functional and cosmetic outcomes following septorhinoplasty surgery. These results help support the case for septorhinoplasty surgery to continue being funded as an NHS procedure.
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Project description:Study designMulticenter validation study.ObjectiveThe aim of this study was to translate and adapt the AOSpine PROST (Patient Reported Outcome Spine Trauma) into English, and test its psychometric properties among North-American spine trauma patients.Summary of background dataIn the absence of an outcome instrument specifically designed and validated for traumatic spinal column injury patients, it is difficult to measure the effect size of various treatment options. The AOSpine Knowledge Forum Trauma initiated a project and developed the AOSpine PROST consisting of 19 items.MethodsPatients were recruited from two level-1 North-American trauma centers. For concurrent validity, next to AOSpine PROST also 36-item Short-Form Health Survey (SF-36) was filled out by patients. Patient characteristics were analyzed using descriptive statistics. Floor and ceiling effects as well as the number of inapplicable and missing questions were analyzed for content validity. Cronbach α and item-total correlation coefficients (ITCCs) were calculated for internal consistency. Spearman correlation tests were performed within AOSpine PROST items and in correlation to SF-36. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs). Factor analysis was performed to explore any dimensions within AOSpine PROST.ResultsThe AOSpine PROST was translated adapted into English using established guidelines. Of 196 enrolled patients, 162 (82.7%) met the inclusion criteria and provided sufficient data. Content validity showed good results, and no floor and ceiling effects were seen. The internal consistency was excellent (Cronbach α = 0.97; ITCC 0.50-0.90) as well as test-retest reliability (ICC = 0.97). Spearman correlations were good (0.29-0.85). The strongest correlations of AOSpine PROST with SF-36 were seen with the physical components (0.69-0.82; P < 0.001). Factor analysis revealed two possible dimensions (Eigen values >1), explaining 75.7% of variance.ConclusionThe English version of AOSpine PROST showed very good validity and reliability. It is considered as a valuable tool, and has the potential to contribute to the reduction of ongoing controversies in spine trauma care.Level of evidence2.
| S-EPMC7439930 | biostudies-literature
Project description:Patient Reported Outcome Measures (PROM) evoke measurements that allow capturing patients' perspectives on their condition. In endometriosis care, physicians' understanding of the effect of the disease and the treatment on patients is often poor. The use of PROMs in endometriosis clinical practice can facilitate patient-provider communication and the implementation of patient-centered care, improve patients' quality of life, as well as provide a tool for patients' self-management of the disease. Today, PROMs are extensively used in research and clinical trials, however they are barely used in clinical practice. The development of digital tools facilitating capturing PROMs can contribute to their use by physicians in routine endometriosis care. However, all PROMs are not adapted to be used in routine care in the context of endometriosis. The objective of this study was to present a catalogue of available PROMs for routine endometriosis care and evaluate them according to selected criteria. To do so, we explored the different PROMs currently in the literature. Consequently, 48 PROM were identified as tools used to evaluate various dimensions of the impact of endometriosis on patients. The selected PROMs were evaluated for their potential to be used as a standard in clinical practice in endometriosis. The selected catalogue of PROMs is the starting point for the integration of digital tools to capture PROMs and the development of patient-centered dashboards to be used by patients and clinicians in endometriosis care and self-management to improve care processes, patient satisfaction, quality of life, and outcomes.
| S-EPMC8585017 | biostudies-literature
Project description:BackgroundContent validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM's content validity and grading the quality of the evidence in systematic reviews of PROMs.MethodsAn online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales ('strongly disagree' to 'strongly agree'), and provided arguments for their ratings.ResultsDiscussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM.DiscussionThe consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.
| S-EPMC5891557 | biostudies-literature
Project description:ObjectiveThis scoping review aims to characterize the current literature on electronic patient-reported outcome measures (ePROMs) in rheumatology and assess the feasibility and utility of ePROMs and mobile health technology in the management of rheumatic disease.IntroductionPatient-reported outcome measures (PROMs) are commonly used in rheumatology as they are important markers of disease activity and overall function, encourage shared decision-making, and are associated with high rates of patient satisfaction. With the widespread use of mobile devices, there is increasing interest in the use of mobile health technology to collect electronic PROMs (ePROM).Inclusion criteriaAll primary studies that involve the collection of ePROMs using mobile devices by individuals with a rheumatic disease were included. Articles were excluded if ePROMs were measured during clinic appointments.MethodsA scoping review was performed using Medline, Embase, PsycINFO, and CINAHL with index terms and key words related to "patient-reported outcome measures", "rheumatic diseases", and "mobile health technology".ResultsA total of 462 records were identified after duplicates were removed. Of the 70 studies selected for review, 43% were conference proceedings and 57% were journal articles, with the majority published in 2016 or later. Inflammatory arthritis was the most common rheumatic disease studied. Generic ePROMs were used over three times more often than disease-specific ePROMs. A total of 39 (56%) studies directly evaluated the feasibility of ePROMs in clinical practice, 19 (27%) were clinical trials that used ePROMs as study endpoints, 9 (13%) were focus groups or surveys on smartphone application development, and 3 (4%) did not fit into one defined category.ConclusionThe use of ePROMs in rheumatology is a growing area of research and shows significant utility in clinical practice, particularly in inflammatory arthritis. Further research is needed to better characterize the feasibility of ePROMs in rheumatology and their impact on patient outcomes.
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Project description: Not available
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