Dataset Information

Patient-Reported Adverse Events of Radiopharmaceuticals: Development and Validation of a Questionnaire.

ABSTRACT: INTRODUCTION:Radiopharmaceuticals may cause adverse events. Knowledge about adverse events from a patient's perspective could help healthcare professionals to detect, understand, and manage adverse events more efficiently when using radiopharmaceuticals. Researchers need a validated questionnaire that can be used in patients to assess adverse events with radiopharmaceuticals. OBJECTIVE:The aim of this study was to develop, validate the content of, and perform initial testing of a questionnaire assessing patient-reported adverse events of radiopharmaceuticals. METHODS:Based on existing literature, six professionals drafted and evaluated a first version of the questionnaire. Further content validation was performed using cognitive interviews with six patients undergoing a nuclear medicine examination. After adaptations, the questionnaire was developed into a web-based questionnaire. One hundred patients undergoing nuclear examination tested this version, and the results were used to assess its acceptability and evaluate reported adverse events. RESULTS:Questions and answer options were revised in the initial questionnaire to improve clarity. In addition, some questions were removed. The final version consisted of 18 questions. In the test phase, the acceptability of the questionnaire was demonstrated (e.g. 79% of the patients who received the questionnaire completed it, and the median time to complete the questionnaire was 12 min for patients who reported an adverse event). Of the 100 patients (53% men, median age 64 years), 12 reported a total of 22 adverse events. One of these adverse events had a high causal association. CONCLUSION:After validation and testing, the developed questionnaire to study patient-reported adverse events of radiopharmaceuticals is a suitable and valid instrument which can be used in future research.

SUBMITTER: Schreuder N

PROVIDER: S-EPMC7105441 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Patient-Reported Adverse Events of Radiopharmaceuticals: Development and Validation of a Questionnaire.

Schreuder Nanno N de Hoog Quincy Q de Vries Sieta T ST Jager Pieter L PL Kosterink Jos G W JGW van Puijenbroek Eugène P EP

Drug safety 20200401 4

<h4>Introduction</h4>Radiopharmaceuticals may cause adverse events. Knowledge about adverse events from a patient's perspective could help healthcare professionals to detect, understand, and manage adverse events more efficiently when using radiopharmaceuticals. Researchers need a validated questionnaire that can be used in patients to assess adverse events with radiopharmaceuticals.<h4>Objective</h4>The aim of this study was to develop, validate the content of, and perform initial testing of a ...[more]

PMID: 31916082

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Project description:IntroductionAdverse events of radiopharmaceuticals may be underreported or remain undetected. Patients can provide information about these adverse events to enable healthcare professionals to detect, understand, and manage them more efficiently.ObjectiveIn this study, we aimed to (a) determine the type, causality, and frequency of patient-reported adverse events of radiopharmaceuticals and to (b) assess the onset, outcome, and follow-up of these adverse events from the patient's perspective.MethodsWe performed a prospective cohort study of 1002 patients who underwent a nuclear medicine examination. Using a validated questionnaire, we collected patient-reported information on adverse events that occurred immediately after administration of the radiopharmaceutical as well as those that occurred later. Adverse events were analysed, coded and assessed for causality by two independent researchers.ResultsA total of 187 (18.7%) patients reported 379 adverse events. Most patient-reported adverse events of radiopharmaceuticals belonged to the 'general disorder and administration site conditions' (42.0%) and 'nervous system disorders' (16.9%) system organ classes. Of the patient-reported adverse events, 43.0% were possibly or probably causally related to radiopharmaceuticals. We found the frequency of patient-reported adverse drug reactions to diagnostic radiopharmaceuticals to be 2.8%. No important medical events were related to the administrations of diagnostic radiopharmaceuticals. Most adverse events (80.0%) occurred shortly after administration of the radiopharmaceutical and were resolved within a few hours. Some events (20.0%) emerged after patients had left the nuclear medicine department, took longer to resolve, and sometimes prompted the patient to consult a healthcare professional.ConclusionAdverse reactions to diagnostic radiopharmaceuticals can occur, and the frequency reported by patients was found to be 2.8%, which is higher than reported in the existing literature. We hope that the results of this study increase awareness of these adverse reactions among patients and healthcare professionals.

Project description:BackgroundPromoting medication adherence is a recognized challenge for prescribers. In this study, we examine whether lower medication adherence is associated with adverse safety events in individuals with decreased estimated glomerular filtration rates (eGFRs).Study designCross-sectional baseline analysis of prospective cohort.Setting & participantsBaseline analysis of the Safe Kidney Care (SKC) Cohort Study, a prospective study of individuals with eGFRs<60 mL/min/1.73 m(2) intended to assess the incidence of disease-specific safety events. Kidney transplant recipients were excluded.PredictorSelf-reported medication adherence based on responses to 3 questions ascertaining degree of medication regimen adherence.OutcomesAdverse safety events were self-reported at baseline (class I events), such as hypoglycemia or fall thought to be related to a medication, or detected incidentally during the baseline visit (class II events), for example, hypotension or hyperkalemia. Potential drug-related problems (DRPs) were determined by analyzing participants' medications with respect to dosing guidelines based on their screening eGFRs at the time of medication reporting.MeasurementsRelationship between medication adherence and disease-specific patient safety events.ResultsOf 293 SKC participants, 154 (53%) were classified as having lower medication adherence. After multivariable adjustment, lower medication adherence was significantly associated with a class I or II safety event (prevalence ratio [PR], 1.21; 95% CI, 1.04-1.41) and potential DRPs (PR, 1.29; 95% CI, 1.02-1.63). Lower medication adherence was also significantly associated with multiple (≥2) class I events (PR, 1.71; 95% CI, 1.18-2.49), multiple class I or II events (PR, 1.35; 95% CI, 1.04-1.76), and multiple potential DRPs (PR, 2.11; 95% CI, 1.08-2.69) compared with those with higher medication adherence.LimitationsUse of self-reported medication adherence rather than pharmacy records. Clinical relevance of detected safety events is unclear.ConclusionsLower medication adherence is associated with adverse safety events in individuals with eGFRs<60 mL/min/1.73 m(2).

Project description:ObjectivesCompassion is a key indicator of quality care that is reportedly eroding from patients' care experience. While the need to assess compassion is recognised, valid and reliable measures are lacking. This study developed and validated a clinically informed, psychometrically rigorous, patient-reported compassion measure.DesignData were collected from participants living with life-limiting illnesses over two study phases across four care settings (acute care, hospice, long term care (LTC) and homecare). In phase 1, data were analysed through exploratory factor analysis (EFA), with the final items analysed via confirmatory factor analysis (CFA) in phase 2. The Schwartz Center Compassionate Care Scale (SCCCS), the revised Edmonton Symptom Assessment Scale (ESAS-r) and Picker Patient Experience Questionnaire (PPEQ) were also administered in phase 2 to assess convergent and divergent validity.Setting and participants633 participants were recruited over two study phases. In the EFA phase, a 54-item version of the measure was administered to 303 participants, with 330 participants being administered the final 15-item measure in the CFA phase.ResultsBoth EFA and CFA confirmed compassion as a single factor construct with factor loadings for the 15-item measure ranging from 0.76 to 0.86, with excellent test-retest reliability (intraclass correlation coefficient range: 0.74-0.89) and excellent internal reliability (Cronbach's alpha of 0.96). The measure was positively correlated with the SCCCS (r=0.75, p<0.001) and PPEQ (r=0.60, p<0.001). Participants reporting higher experiences of compassion had significantly greater well-being and lower depression on the ESAS-r. Patients in acute care and hospice reported significantly greater experiences of compassion than LTC residents.ConclusionsThere is strong initial psychometric evidence for the Sinclair Compassion Questionnaire (SCQ) as a valid and reliable patient-reported compassion measure. The SCQ provides healthcare providers, settings and administrators the means to routinely measure patients experiences of compassion, while providing researchers a robust measure to conduct high-quality research.

Project description:UnlabelledTreatment of polycystic liver disease (PLD) focuses on symptom improvement. Generic questionnaires lack sensitivity to capture PLD-related symptoms, a prerequisite to determine effectiveness of therapy. We developed and validated a disease-specific questionnaire that assesses symptoms in PLD (PLD-Q). We identified 16 PLD-related symptoms (total score 0-100 points) by literature review and interviews with patients and clinicians. The developed PLD-Q was validated in Dutch (n = 200) and United States (US; n = 203) PLD patients. We assessed the correlation of PLD-Q total score with European Organization for Research and Treatment of Cancer (EORTC) symptom scale, global health visual analogue scale (VAS) of EQ-5D, and liver volume. To test discriminative validity, we compared PLD-Q total scores of patients with different PLD severity stages (Gigot classification) and PLD-Q total scores of PLD patients with general controls and polycystic kidney disease patients without PLD. Reproducibility was tested by comparing original test scores with 2-week retest scores. In total, 167 Dutch and 124 US patients returned the questionnaire. Correlation between PLD-Q total score and EORTC symptom scale (The Netherlands [NL], r = 0.788; US, r = 0.811) and global health VAS (NL, r = -0.517; US, r = -0.593) was good. There was no correlation of PLD-Q total score with liver volume (NL, r = 0.138; P = 0.236; US, r = 0.254; P = 0.052). Gigot type III individuals scored numerically higher than type II patients (NL, 46 vs. 40; P = 0.089; US, 48 vs. 36; P = 0.055). PLD patients scored higher on the PLD-Q total score than general controls (NL, 42 vs. 17; US, 40 vs. 13 points) and polycystic kidney disease patients without PLD (22 points). Reproducibility of PLD-Q was excellent (NL, r = 0.94; US, 0.96).ConclusionPLD-Q is a valid, reproducible, and sensitive disease-specific questionnaire that can be used to assess PLD-related symptoms in clinical care and future research. (Hepatology 2016;64:151-160).

Project description:BackgroundIntegrating the patient's perspective has become an increasingly important component of adverse event reporting. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). This instrument has been translated into German and linguistically validated; however, its quantitative measurement properties have not been evaluated.Patients and methodsA German language survey that included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in Germany and Austria. Item quality was assessed by analysis of acceptability and comprehensibility. Reliability was evaluated by using Cronbach's' alpha and validity by principal components analysis (PCA), multitrait-multimethod matrix (MTMM) and known groups validity techniques.ResultsOf 660 surveys distributed to the study centres, 271 were returned (return rate 41%), and data from 262 were available for analysis. Participants' median age was 59.7 years, and 69.5% of the patients were female. Analysis of item quality supported the comprehensibility of the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation coefficients were >0.9 for almost all item clusters. Construct validity of the PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item clusters via PCA. Moreover, construct validity was confirmed by the MTMM: monotrait-heteromethod comparison showed 100% high correlation, whereas heterotrait-monomethod comparison indicated 0% high correlation. Known groups validity was supported; PRO-CTCAE scores were significantly lower for those with impaired versus preserved health-related quality of life.ConclusionA set of 31 items drawn from the German PRO-CTCAE item library demonstrated favourable measurement properties. These findings add to the body of evidence that PRO-CTCAE provides a rigorous method to capture patient self-reports of symptomatic toxicity for use in cancer clinical trials.

Project description:BackgroundCritical reflection by faculty physicians on adverse patient events is important for changing physician's behaviors. However, there is little research regarding physician reflection on quality improvement (QI).ObjectiveTo develop and validate a computerized case-based learning system (CBLS) to measure faculty physicians' reflections on adverse patient events.DesignProspective validation study.ParticipantsStaff physicians in the Department of Medicine at Mayo Clinic Rochester.Main measuresThe CBLS was developed by Mayo Clinic information technology, medical education, and QI specialists. The reflection questionnaire, adapted from a previously validated instrument, contained eight items structured on five-point scales. Three cases, representing actual adverse events, were developed based on the most common error types: systems, medication, and diagnostic. In 2009, all Mayo Clinic hospital medicine, non-interventional cardiology, and pulmonary faculty were invited to participate. Faculty reviewed each case, determined the next management step, rated case generalizability and relevance, and completed the reflection questionnaire. Factor analysis and internal consistency reliability were calculated. Associations between reflection scores and characteristics of faculty and patient cases were determined.Key resultsForty-four faculty completed 107 case reflections. The CBLS was rated as average to excellent in 95 of 104 (91.3%) completed satisfaction surveys. Factor analysis revealed two levels of reflection: Minimal and High. Internal consistency reliability was very good (overall Cronbach's α=0.77). Item mean scores ranged from 2.89 to 3.73 on a five-point scale. The overall reflection score was 3.41 (standard deviation 0.64). Reflection scores were positively associated with case generalizability (p=0.001), and case relevance (p=0.02).ConclusionsThe CBLS is a valid method for stratifying faculty physicians' levels of reflection on adverse patient events. Reflection scores are associated with case generalizability and relevance, indicating that reflection improves with pertinent patient encounters. We anticipate that this instrument will be useful in future research on QI among low versus high-reflecting physicians.

Dataset Information

Patient-Reported Adverse Events of Radiopharmaceuticals: Development and Validation of a Questionnaire.

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Patient-Reported Adverse Events of Radiopharmaceuticals: Development and Validation of a Questionnaire.

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