Communication Of Incidental Findings Research Articles

Reply to “Augmenting Follow-up of Incidental Findings”

We appreciate Lee and Delaney’s interest in our scoping review [1] and their insights on additional management strategies to promote follow-up care for incidental findings (IFs). We agree that communication of IFs to referring providers is a critical action in the IF clinical pathway leading to guideline-concordant care delivery. The importance of effective processes to communicate results is illustrated in these authors’ prior research, which revealed significant delays in follow-up investigations of IFs, despite urgent care recommendations [2].

Prevalence, documentation, and communication of incidental findings in focused assessment with sonography for trauma (FAST) examinations

BackgroundAs the focused assessment with sonography for trauma (FAST) examination becomes increasingly ubiquitous in the emergency department (ED), a parallel increase in incidental findings can also be expected. The purpose of this study was to determine the prevalence, documentation, and communication of incidental findings on emergency physician-performed FAST examinations. MethodsRetrospective review at two academic EDs. Adult trauma patients undergoing FAST examinations used for clinical decision-making at the bedside were identified from an ED ultrasound image archival system. Expert sonologists reviewed ultrasound images for incidental findings, as well as electronic medical records for demographic information, mechanism of injury, type of incidental findings, documentation of incidental findings, and communication of incidental findings to the patient. ResultsA total of 1,452 FAST examinations were reviewed. One hundred and thirty-seven patients with incidental findings were identified (9.4%); 7 patients had an additional incidental finding. Renal cysts were most common (49/144, 34.0%), followed by pelvic cysts in women (32/144, 22.2%). While 31/144 (21.5%) incidental findings were identified and documented in the ultrasound reports or medical records by ED providers, only 6/137 (4.4%) patients were noted to be informed of their incidental findings. ConclusionIncidental findings were often encountered in FAST examinations, with cysts of the kidneys and pelvis being the most common findings. A vast majority of incidental findings were not documented or noted to be communicated to patients, which can be a barrier to follow-up care.

378 Prevalence and Follow-Up of Incidental Findings in Focused Assessment With Sonography for Trauma Examinations

The focused assessment with sonography for trauma (FAST) is a commonly performed point-of-care ultrasound examination to evaluate trauma patients in the emergency department (ED). Incidental findings in imaging studies are a common occurrence with variable clinical significance. Failure to communicate these findings to patients can potentially lead to adverse outcomes and medico legal claims. To our knowledge, no prior study has been performed regarding the frequency and follow-up of incidental findings encountered by emergency physicians on FAST examinations. The objective of this study was to determine the frequency, documentation, and communication of incidental findings on emergency physician-performed FAST ultrasound examinations. This is a retrospective review of FAST examinations performed by emergency physicians for adult trauma patients in two academic EDs. FAST examinations used for medical decision making at the bedside were identified from ED ultrasound image archival system (Q-path). Emergency medicine residents and attending physicians with varied point-of-care ultrasound experience performed and interpreted FAST ultrasound examinations. All identified FAST examinations were reviewed by one of the study investigators for the presence of incidental findings. Additionally, an expert emergency sonologist reviewed all FAST examinations with incidental findings and 10% of FAST examinations with no incidental findings. The patients’ medical records were then reviewed for demographic information, mechanism of injury, type of incidental findings, documentation of incidental findings, and communication of incidental findings with the patient. Continuous variables were reported as means with standard deviations and categorical variables were reported as proportions. Inter-rater reliability was assessed using the kappa test statistic. A total of 1452 FAST examinations were reviewed over a 15-month period. One hundred and thirty-seven patients with incidental findings were identified (9.4%); 7 patients had more than one incidental finding. Inter-rater reliability among reviewers was very high (92%). The mean age of patients (78 females, 59 males) with incidental findings was 52 (SD 23); without, 44 (SD 19, p<.001). Motor vehicle collision was the most common mechanism of injury, followed by falls. Renal pathology (cysts and hydronephrosis) was the most common finding (57/137, 41.6%), followed by pelvic cysts in women (40/137, 29.1%). While 31/137 (22.6%) incidental findings were identified and documented in the ultrasound reports by ED providers, only 6/137 (4.4%) patients were informed of their incidental findings. Incidental findings are often encountered in FAST ultrasound examinations, most commonly in older, female patients. A vast majority of incidental findings were not documented and communicated to patients, which may have medico legal implications.

Discovery and informing research participants of incidental findings detected in brain magnetic resonance imaging studies: Review and multi-institutional study.

BackgroundBrain imaging studies using magnetic resonance imaging (MRI) sometimes reveal incidental findings (IFs) that might be relevant to some of the health issues in research participants. Although professional communities have discussed how to manage these IFs, there is no global consensus on the concrete handling procedures including how to inform participants of IFs.MethodsFirst, this study reviewed previous studies for the number of IFs discovered in brain imaging studies using MEDLINE. Second, a multi‐institutional study determined the number of IF discoveries and evaluated the method of informing participants at multiple institutions, which participated in a national brain science project in Japan.ResultsBoth the review and multi‐institutional study showed that IFs with a high urgency level were discovered in 0–2.0% of participants, including healthy volunteers, and that the rate of IF discovery in general was higher in studies conducted in elderly population. Moreover, multi‐institutional study suggested the criteria used to judge whether or not to inform participants of IFs may differ by institution.ConclusionsOur results suggest that in order to ensure informing the participants of high urgency IFs, physicians who are capable of interpreting brain images clinically should review all brain images, and the establishment of a support system is required for brain imaging studies at nonmedical institutions. Since the method of informing participants of IFs might affect their understanding and acceptance of IFs, which are related to managing risks of false “clean bill of health” or psychological impacts of informing IFs, further research focusing on communication of IFs is needed.

Ethical framework for the detection, management and communication of incidental findings in imaging studies, building on an interview study of researchers\u2019 practices and perspectives

BackgroundAs thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like. Building on an interview study of researchers’ practices and perspectives, we identified key considerations for the set-up of pathways for the detection, management and communication of incidental findings in imaging research.MethodsWe conducted an interview study with a purposive sample of researchers (n = 20) at research facilities across the Netherlands. Based on a qualitative analysis of these interviews and on existing guidelines found in the literature, we developed a prototype ethical framework, which was critically assessed and fine-tuned during a two-day international expert meeting with bioethicists and representatives from large population-based imaging studies from the United Kingdom, Germany, Sweden and Belgium (n = 14).ResultsPractices and policies for the handling of incidental findings vary strongly across the Netherlands, ranging from no review of research scans and limited feedback to research participants, to routine review of scans and the arrangement of clinical follow-up. Respondents felt that researchers do not have a duty to actively look for incidental findings, but they do have a duty to act on findings, when detected. The principle of reciprocity featured prominently in our interviews and expert meeting.ConclusionWe present an ethical framework that may guide researchers and research ethics committees in the design and/or evaluation of appropriate pathways for the handling of incidental findings in imaging studies. The framework consists of seven steps: anticipation of findings, information provision and informed consent, scan acquisition, review of scans, consultation on detected abnormalities, communication of the finding, and further clinical management and follow-up of the research participant. Each of these steps represents a key decision to be made by researchers, which should be justified not only with reference to costs and/or logistical considerations, but also with reference to researchers’ moral obligations and the principle of reciprocity.

Psychosocial consequences and severity of disclosed incidental findings from whole-body MRI in a general population study

Little is known about the psychosocial impact and subjective interpretation of communicated incide ntal findings from whole-body magnetic resonance imaging (wb-MRI). This was addressed with this general population study. Data was based on the Study of Health in Pomerania (SHIP), Germany. SHIP comprised a 1.5-T wb-MRI examination. A postal survey was conducted among the first 471 participants, aged 23-84 years, who received a notification about incidental findings (response 86.0 %, n = 405). The severity of incidental findings was assessed from the participants' and radiologists' perspective. In total, 394 participants (97.3 %) wanted to learn about their health by undergoing wb-MRI. Strong distress while waiting for a potential notification of an incidental finding was reported by 40 participants (9.9 %), whereas 116 (28.6 %) reported moderate to severe psychological distress thereafter. Strong disagreement was noted between the subjective and radiological evaluation of the findings' severity (kappa = 0.02). Almost all participants (n = 389, 96.0 %) were very satisfied with their examination. Despite the high satisfaction of most participants, there were numerous adverse consequences concerning the communication of incidental findings and false expectations about the likely potential benefits of whole-body-MRI. • Disclosed incidental findings from MRI may lead to substantial psychosocial distress. • Subjective and radiological evaluations of incidental findings' severity differ strongly. • Disclosing incidental findings is strongly endorsed by study volunteers. • Study volunteers tend to have false expectations about potential benefits from MRI. • Minimizing stress in study volunteers should be a key aim in MRI research.

Use of next generation sequencing technologies in research and beyond: are participants with mental health disorders fully protected?

BackgroundNext Generation Sequencing (NGS) is expected to help find the elusive, causative genetic defects associated with Bipolar Disorder (BD). This article identifies the importance of NGS and further analyses the social and ethical implications of this approach when used in research projects studying BD, as well as other psychiatric ailments, with a view to ensuring the protection of research participants.MethodsWe performed a systematic review of studies through PubMed, followed by a manual search through the titles and abstracts of original articles, including the reviews, commentaries and letters published in the last five years and dealing with the ethical and social issues raised by NGS technologies and genomics studies of mental disorders, especially BD. A total of 217 studies contributed to identify the themes discussed herein.ResultsThe amount of information generated by NGS renders individuals suffering from BD particularly vulnerable, and increases the need for educational support throughout the consent process, and, subsequently, of genetic counselling, when communicating individual research results and incidental findings to them. Our results highlight the importance and difficulty of respecting participants’ autonomy while avoiding any therapeutic misconception. We also analysed the need for specific regulations on the use and communication of incidental findings, as well as the increasing influence of NGS in health care.ConclusionsShared efforts on the part of researchers and their institutions, Research Ethics Boards as well as participants’ representatives are needed to delineate a tailored consent process so as to better protect research participants. However, health care professionals involved in BD care and treatment need to first determine the scientific validity and clinical utility of NGS-generated findings, and thereafter their prevention and treatment significance.