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Exploring differences in symptomatic adverse events assessment between nurses and physicians in the clinical trial setting.

ABSTRACT: A cross-sectional study was performed at Hebei Medical University Fourth Affiliated Hospital from April to July 2020 to explore the difference and consistency between nurses and physicians in terms of symptomatic adverse event (AE) assessment. The Common Terminology Criteria for Adverse Events (CTCAE) was utilized by nurses and physicians to assess patients' symptomatic AEs. Patients self-reported their AEs utilizing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Four nurses and three physicians were enrolled to assess patients' symptomatic AEs. Given the same AEs, nurses tended to detect more AEs than physicians, and the differences were statistically significant (P < 0.001). The toxicity grade reported by nurses and physicians showed no difference for all AEs, except for fatigue (χ² = 5.083, P = 0.024). The agreement between nurses and patients was highest compared to the agreement between nurses versus physicians and physicians versus patients. The differences in symptomatic AE assessment can lead to different symptom management. Thus, it is important to establish a collaborative approach between nurses and physicians to ensure continuity in care delivery.

SUBMITTER: Liu L

PROVIDER: S-EPMC10039895 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Exploring differences in symptomatic adverse events assessment between nurses and physicians in the clinical trial setting.

Liu Lei L Liu Zhanlun Z Ma Cuicui C Cheng Meng M Xie Yanli Y Zhang Lina L Wang Jianxin J

Scientific reports 20230325 1

A cross-sectional study was performed at Hebei Medical University Fourth Affiliated Hospital from April to July 2020 to explore the difference and consistency between nurses and physicians in terms of symptomatic adverse event (AE) assessment. The Common Terminology Criteria for Adverse Events (CTCAE) was utilized by nurses and physicians to assess patients' symptomatic AEs. Patients self-reported their AEs utilizing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Ad ...[more]

PMID: 36966242

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Project description:ImportanceIn cancer clinical trials, symptomatic adverse events (AEs), such as nausea, are reported by investigators rather than by patients. There is increasing interest to collect symptomatic AE data via patient-reported outcome (PRO) questionnaires, but it is unclear whether it is feasible to implement this approach in multicenter trials.ObjectiveTo examine whether patients are willing and able to report their symptomatic AEs in multicenter trials.Design, setting, and participantsA total of 361 consecutive patients enrolled in any 1 of 9 US multicenter cancer treatment trials were invited to self-report 13 common symptomatic AEs using a PRO adaptation of the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) via tablet computers at 5 successive clinic visits. Patient adherence was tracked with reasons for missed self-reports. Agreement with clinician AE reports was analyzed with weighted κ statistics. Patient and investigator perspectives were elicited by survey. The study was conducted from March 15, 2007, to August 11, 2011. Data analysis was performed from August 9, 2013, to March 21, 2014.ResultsOf the 361 patients invited to participate, 285 individuals enrolled, with a median age of 57 years (range, 24-88), 202 (74.3%) female, 241 (85.5%) white, 73 (26.8%) with a high school education or less, and 176 (64.7%) who reported regular internet use (denominators varied owing to missing data). Across all patients and trials, there were 1280 visits during which patients had an opportunity to self-report (ie, patients were alive and enrolled in a treatment trial at the time of the visit). Self-reports were completed at 1202 visits (93.9% overall adherence). Adherence was highest at baseline and declined over time (visit 1, 100%; visit 2, 96%; visit 3, 95%; visit 4, 91%; and visit 5, 85%). Reasons for missing PROs included institutional errors in 27 of 48 (56.3%) of the cases (eg, staff forgetting to bring computers to patients at visits), patients feeling "too ill" in 8 (16.7%), patient refusal in 8 (16.7%), and internet connectivity problems in 5 (10.4%). Patient-investigator CTCAE agreement was moderate or worse for most symptoms (most κ < 0.05), with investigators reporting fewer AEs than patients across symptoms. Most patients believed that the system was easy to use (234 [93.2%]) and useful (230 [93.1%]), and investigators thought that the patient-reported AEs were useful (133 [94.3%]) and accurate (119 [83.2%]).Conclusions and relevanceParticipants in multicenter cancer trials are willing and able to report their own symptomatic AEs at most clinic visits and report more AEs than investigators. This approach may improve the precision of AE reporting in cancer trials.

Project description:BackgroundClinician reporting of symptomatic adverse events (AEs) in phase I trials uses the Common Terminology Criteria for Adverse Events (CTCAE). The utility of the patient-reported outcomes (PROs) version of the CTCAE (PRO-CTCAE) in this setting is unknown. This prospective, observational study compared patient- and clinician-reported symptomatic AEs in phase I patients.MethodsPhase I study-eligible patients at Princess Margaret were surveyed with the PRO-CTCAE full-item library (78 symptomatic AEs) at baseline (BL), mid-cycle 1, and mid-cycle 2 (C2). Patient and trial characteristics, best response, and survival data were collected. Presence or absence of patient- (PRO-CTCAE) or clinician-reported symptomatic AEs were compared (kappa) at defined timepoints and overall (BL+ mid-cycle 1 + C2).ResultsOf 292 patients approached from May 2017 to January 2019, a total of 265 (90.8%) were consented, with 243 (91.7%) evaluable and 552 PRO-CTCAE surveys (completion rate = 98.7%) included in analyses. Evaluation of overall patient-reported symptomatic AEs identified 50 PRO-CTCAE and 11 CTCAE items with 10% or greater reporting frequency. Nineteen CTCAE items were reported as 1% or less despite matched PRO-CTCAE items reporting as 10% or greater. Underreported categories included sexual health, bodily emissions, and cognition. Clinician- relative to patient-reporting frequency (ratio) demonstrated 9 symptomatic AEs with a 50-fold or more lower clinician reporting rate. Overall patient-clinician agreement for individual symptomatic AEs ranged from poor (κ = 0.00-0.19) to moderate (κ = 0.40-0.59), with discordance driven by lack of clinician reporting. Dyspnea (κ = 0.54) and peripheral neuropathy (κ = 0.63) at BL and limb edema (κ = 0.55) at C2 demonstrated the highest patient-clinician agreement.ConclusionsPoor to moderate patient-clinician agreement for symptomatic AEs suggests clinician underreporting in phase I trials. Analyses of severity and interference PRO categories are ongoing.

Project description:In clinical trials, adverse events are usually self-reported but may be adjudicated if serious or of particular interest. After adjudicating cardiovascular events for a 5-year calcium supplement trial, we observed discrepancies between self-reported and verified events. We systematically analysed those differences to assess their importance. Secondary analysis of adverse cardiovascular events in a 5-year, randomised, placebo-controlled trial of calcium supplementation (1 g calcium daily) in 1471 postmenopausal women (mean age 74 years). Clinical research centre. The participant's medical records were reviewed for all self-reported myocardial infarctions (MIs) or strokes, and the event independently adjudicated. Cause of death was obtained from hospital records or death certificates. To identify unreported events, the national hospital discharge database was searched and related hospital records were reviewed. 45 women reported 64 MIs, of which 33 (52%) were verified after adjudication. An additional 25 MIs were identified: 1 during adjudication of other events, 21 from the hospital discharge database, 3 from death certificates. 68 women reported 86 strokes of which 50 (58%) were verified. An additional 13 strokes were identified: 7 during adjudication of reported transient ischaemic attacks, 5 from the hospital discharge database, 1 from death certificates. Therefore, 43% of verified MIs and 21% of verified strokes were not reported to investigators. For non-adjudicated discharge codes, 10% of MIs and 22% of strokes were not verified after adjudication. Nineteen per cent of verified MIs and 27% of verified strokes were not identified in discharge coding or death certificates. Neither the event source nor the level of adjudication altered the relationship between treatment allocation and cardiovascular events. When adverse event accuracy is critical, researchers should consider adjudicating self-reported events and hospital discharge codes, and attempt to identify unreported events. Australia New Zealand Clinical Trials registry: ACTRN 012605000242628.

Project description:BackgroundEducational activities for physicians sponsored by opioid manufacturers are implicated in the over- and mis-prescribing of opioids. However, the implications of promotion to nurses are poorly understood. Nurses play a key role in assessing pain, addressing the determinants of pain, and administering opioid medications. We sought to understand the nature and content of pain-related educational events sponsored by opioid manufacturers and to compare events targeting physicians and nurses.MethodsWe conducted a cross sectional, descriptive analysis of pharmaceutical company reports detailing 116,845 sponsored educational events attended by health professionals from 2011 to 2015 in Australia. We included events that were sponsored by manufacturers of prescription opioid analgesics and were pain related. We compared event characteristics across three attendee groups: (a) physicians only; (b) at least one nurse in attendance; and (c) nurses only. We coded the unstructured data using iteratively generated keywords for variables related to location, format, and content focus.ResultsWe identified 3,411 pain-related events sponsored by 3 companies: bioCSL/CSL (n = 15), Janssen (n = 134); and Mundipharma (n = 3,262). Pain-related events were most often multidisciplinary, including at least one nurse (1,964/3,411; 58%); 38% (1,281/3,411) included physicians only, and 5% (166/3,411) nurses only. The majority of events were held in clinical settings (61%) and 43% took the form of a journal club. Chronic pain was the most common event topic (26%) followed by cancer pain and palliative care (18%), and then generic or unspecified references to pain (15%); nearly a third (32%) of event descriptions contained insufficient information to determine the content focus. Nurse-only events were less frequently held in clinical settings (32%; p < .001) and more frequently were product launches (17%; p < .001) and a significantly larger proportion focused on cancer or palliative care (33%; p < .001), generic pain topics (27%; p < .001), and geriatrics (25%; p < .001) than physician-only or multidisciplinary events.DiscussionOpioid promotion via sponsored educational events extends beyond physicians to multidisciplinary teams and specifically, nurses. Despite lack of evidence that opioids improve outcomes for long-term chronic non-cancer pain, hundreds of sponsored educational events focused on chronic pain. Regulators should consider the validity of distinguishing between pharmaceutical companies' "promotional" and "non-promotional" activities.

Project description:PurposeTo assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).Methods and materialsPatients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed.ResultsAmong 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling "too sick."ConclusionsMost patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between visits, and by using central compliance monitoring. These approaches are being incorporated into ongoing studies.

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Exploring differences in symptomatic adverse events assessment between nurses and physicians in the clinical trial setting.

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Exploring differences in symptomatic adverse events assessment between nurses and physicians in the clinical trial setting.

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