12 hours ago · Comparing patient and physician reports. The comparison of patient- and physician-reported adverse reactions during the trial is provided as absolute frequencies, proportions (%), and categories (Table 2). It shows differences between patients’ and physicians’ ratings for the main categories: BLEEDING/HAEMATOMA (patients: 2458 (6.7%), considered as ‘common’ vs. physicians: 255 (0.6%), ‘uncommon’), PAIN (636 (1.7%), … >> Go To The Portal
The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) is a standard assessment tool of treatment-related AEs. 5 However, this assessment is performed by physicians and is not based on direct reports provided by patients themselves; thus, there is a risk of missing the patients’ input even though they are in the best position to comment on their own experiences. 6 In fact, a growing body of evidence suggests that physicians’ reports of their patients’ AEs may be unreliable and frequently underestimated when compared with the patients’ reports of their own AEs, especially for subjective AEs such as symptoms. 6 - 11 Consequently, patient-reported outcomes (PROs) are becoming increasingly relevant to capture a reasonably comprehensive picture of a patient's subjective experience that does not include interpretations of the patient's responses by physicians or anyone else. 12 Although the substantial variability between physician and patient assessments of symptomatic AEs may depend on specific cancer types and treatment, no prior studies have directly compared patients’ and physicians’ reports of symptomatic AEs in mCRC patients treated with first-line cetuximab plus chemotherapy.
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This requirement typically does not affect the need for reporting, but allows the sponsor to provide its own evaluation in the full context of the safety database. For these reasons, planning for high-quality and consistent training in AE reporting requirements across sites is the preferred approach for a patient registry.
Clinician abstractors identified potential errors and AEs by reviewing medical records, hospital incident reports, and clinician reports as well as weekly and discharge Family Safety Interviews (FSIs). Two physicians reviewed and independently categorized all incidents, rating severity and preventability (agreement, 68%–90%; κ, 0.50–0.68).
Since sponsors are not obligated to report AEs for their competitors, it is good practice from a public health perspective to specify how the site should address those AEs (e.g., whether to report directly to the other product's manufacturer or to FDA).
Generally, AE reports are submitted directly by the site or by the registry to the manufacturer, since they are often most efficient at evaluating, processing, and reporting for regulatory purposes within the required time periods.
The minimum dataset required to consider information as a reportable AE is indeed minimal, namely (1) an identifiable patient, (2) an identifiable reporter, (3) product exposure, and (4) an event.
Importantly, physician reviewers agreed that the patient-reported events constituted a true clinical adverse event in more than 70% of cases. This finding corroborates prior research showing that patient-reported adverse events provide an important complementary perspective in assessing organizational safety problems.
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Reporting of adverse events from the point of care is voluntary. FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others).
Reporting adverse events isn't just about patient safety. It also helps protect healthcare organizations from costly liability claims and financial losses caused by reduced reimbursement for the treatment of preventable conditions acquired while in hospital care.
Clinical disclosure of adverse events is a process by which the patient's clinician informs the patient or the patient's personal representative, as part of routine clinical care, that a harmful or potentially harmful adverse event has occurred during the patient's care (see paragraph 8).
Adverse events are graded on a scale from 1 to 5. (Grade 0 refers to not having a symptom or problem, so someone with grade 0 pain has no pain at all.) Grade 1 adverse events are mild and generally not bothersome. Grade 2 events are bothersome and may interfere with doing some activities but are not dangerous.
In clinical research, a researcher-doctor must report any adverse event to the ethics committee, institution, the office of DCGI and the sponsor (if any) and manage the adverse event without imposing any financial burden to the research participant.
Safety Reporting The sponsor of a clinical trial is responsible for the ongoing safety evaluation of the investigational product or study intervention. Safety reports are submitted to the regulatory agency, the ethics committee, oversight groups, and the sponsor throughout the lifecycle of a trial.
An Adverse Drug Event (ADE) is “Harm caused by appropriate or inappropriate use of a drug whereas adverse drug reactions are a subset of these events, where harm is directly caused by a drug under appropriate use (i.e. at normal doses).
The most common contributing factors were (i) lack of competence, (ii) incomplete or lack of documentation, (iii) teamwork failure and (iv) inadequate communication. Conclusions: The contributing factors frequently interacted yet they varied between different groups of serious adverse events.
Founded in 1993, the MedWatch system includes records created in the FAERS database from reports of adverse events and medication errors by health care professionals, consumers, and drug manufacturers.