Surprise Diagnoses For Research Volunteers
Surprise diagnoses for research volunteers : Nature News
Test scans of the abdomen and brain show high rates of abnormalities.
[As noted in other posts, there is a significant percent of captured endocrine incidentalomas found. Of these, there is said to be about 10% for pituitary incidentalomas. Incidentalomas can lead to what is known as the Cascade Effect. Cascade effect refers to a process that proceeds in stepwise fashion from an initiating event to a seemingly inevitable conclusion. With regard to medical technology, the term refers to a chain of events initiated by an unnecessary test, an unexpected result, or patient or physician anxiety, which results in ill-advised tests or treatments that may cause avoidable adverse effects and/or morbidity.]
27 September 2010
Janelle Weaver
People may volunteer for a study simply to advance science, but a large fraction of them could wind up receiving unnerving news. A paper published today [1] reports finding that 40% of participants in imaging experiments had clinical anomalies beyond the scope of the investigation, and that, of these cases, 6% provoked subsequent medical intervention.
Radiologists at the Mayo Clinic in Rochester, Minnesota, appraise images from research examinations daily and report any potential problems that they spot to physicians. An expert panel of physicians, radiologists and bioethicists assessed the benefits and burdens of radiologists' findings for research examinations taken over three months in 2004 by studying individuals' medical records over a follow-up period of three years. Out of a total of 1,426 examinations, 567 revealed at least one anomaly, and the total tally of anomalies across this subset was more than 1,000.
Similar rates of incidental findings have been reported for imaging experiments in the past, as pointed out in the paper by lead author Joel Fletcher and his team at the Mayo Clinic. However, the authors say this latest study is different from most previous studies because the researchers also compared the prevalence of anomalies among techniques and parts of the body. In addition, they assessed whether or not subsequent treatments helped patients.
Of the 567 volunteers for whom anomalies were identified, 35 underwent additional medical tests or procedures, including surgery. Only six patients improved after interventions, such as surgical resection of masses, and three patients did not improve or worsened. Whether there was any benefit to the remaining 26 patients remains unclear.
Technical variations
Aberrations were most common in computed tomography (CT) examinations of the abdomen, pelvis and thorax, followed by magnetic resonance imaging (MRI) scans of the head. With CT scans of the abdomen and pelvis, about 60% revealed abnormalities such as hardening of the arteries, pouches in the colon and cysts in the kidneys, and 9% led to the individual receiving medical attention. Meanwhile, with MRI scans of the head, more than 40% showed defects, and 2% led to further assessment. By contrast, ultrasonography, plain-film radiography and nuclear medicine tests prompted no follow-ups. Only 1% of examinations with incidental findings led to follow-up procedures that clearly helped patients.
The study has obvious limitations. The authors did not determine, for example, whether diagnoses triggered by incidental findings led to better outcomes than clinical evaluations spurred by symptoms. And they didn't estimate the emotional impact on patients, or the costs of interventions.
In any case, paying radiologists to inspect study images on the off-chance may not be practical at non-medical research institutions, says Peter Bandettini, an expert in functional imaging at the National Institutes of Health in Bethesda, Maryland.
But knowing which tests most often uncover clinically important anomalies could help research committees to set guidelines and allocate resources, he adds. "But it's premature to have a standard overarching protocol, because the benefits of screening are still debated," says Bandettini.
References
1. Orme, N. M. et al. Arch. Intern. Med. 170, 1525-1532 (2010).
2. Illes, J. et al. Science 311, 783-784 (2006).
3. Wolf, S. M. et al. J. Law Med. Ethics 36, 219-248 (2008).
Orme NM, Fletcher JG, Siddiki HA, et al. Incidental Findings in Imaging Research: Evaluating Incidence, Benefit, and Burden. Arch Intern Med 2010;170(17):1525-32.
Background Little information exists concerning the frequency and medical significance of incidental findings (IFs) in imaging research.
Methods Medical records of research participants undergoing a research imaging examination interpreted by a radiologist during January through March 2004 were reviewed, with 3-year clinical follow-up. An expert panel reviewed all IFs generating clinical action to determine medical benefit/burden on the basis of predefined criteria. The frequency of IFs that generated further clinical action was estimated by modality, body part, age, and sex, along with net medical benefit or burden.
Results Of 1426 research imaging examinations, 567 (39.8%) had at least 1 IF (1055 total). Risk of an IF increased significantly by age (odds ratio [OR], 1.5; 95% confidence interval, 1.4-1.7 per decade increase). Abdominopelvic computed tomography generated more IFs than other examinations (OR, 18.9 vs ultrasonography; 9.2% with subsequent clinical action), with computed tomography of the thorax and magnetic resonance imaging of the head next (OR, 11.9 and 5.9; 2.8% and 2.2% with action, respectively). Of the 567 examinations with an IF, 35 (6.2%) generated clinical action, resulting in clear medical benefit in 1.1% (6 of 567) and clear medical burden in 0.5% (3 of 567). Medical benefit/burden was usually unclear (26 of 567 [4.6%]).
Conclusions Frequency of IFs in imaging research examinations varies significantly by imaging modality, body region, and age. Research imaging studies at high risk for generating IFs can be identified. Routine evaluation of research images by radiologists may result in identification of IFs in a high number of cases and subsequent clinical action to address them in a small but significant minority. Such clinical action can result in medical benefit to a small number of patients.
Lo B. Responding to Incidental Findings on Research Imaging Studies: Now What? Arch Intern Med 2010;170(17):1522-4.
Surprise diagnoses for research volunteers : Nature News
Test scans of the abdomen and brain show high rates of abnormalities.
[As noted in other posts, there is a significant percent of captured endocrine incidentalomas found. Of these, there is said to be about 10% for pituitary incidentalomas. Incidentalomas can lead to what is known as the Cascade Effect. Cascade effect refers to a process that proceeds in stepwise fashion from an initiating event to a seemingly inevitable conclusion. With regard to medical technology, the term refers to a chain of events initiated by an unnecessary test, an unexpected result, or patient or physician anxiety, which results in ill-advised tests or treatments that may cause avoidable adverse effects and/or morbidity.]
27 September 2010
Janelle Weaver
People may volunteer for a study simply to advance science, but a large fraction of them could wind up receiving unnerving news. A paper published today [1] reports finding that 40% of participants in imaging experiments had clinical anomalies beyond the scope of the investigation, and that, of these cases, 6% provoked subsequent medical intervention.
Radiologists at the Mayo Clinic in Rochester, Minnesota, appraise images from research examinations daily and report any potential problems that they spot to physicians. An expert panel of physicians, radiologists and bioethicists assessed the benefits and burdens of radiologists' findings for research examinations taken over three months in 2004 by studying individuals' medical records over a follow-up period of three years. Out of a total of 1,426 examinations, 567 revealed at least one anomaly, and the total tally of anomalies across this subset was more than 1,000.
Similar rates of incidental findings have been reported for imaging experiments in the past, as pointed out in the paper by lead author Joel Fletcher and his team at the Mayo Clinic. However, the authors say this latest study is different from most previous studies because the researchers also compared the prevalence of anomalies among techniques and parts of the body. In addition, they assessed whether or not subsequent treatments helped patients.
Of the 567 volunteers for whom anomalies were identified, 35 underwent additional medical tests or procedures, including surgery. Only six patients improved after interventions, such as surgical resection of masses, and three patients did not improve or worsened. Whether there was any benefit to the remaining 26 patients remains unclear.
Technical variations
Aberrations were most common in computed tomography (CT) examinations of the abdomen, pelvis and thorax, followed by magnetic resonance imaging (MRI) scans of the head. With CT scans of the abdomen and pelvis, about 60% revealed abnormalities such as hardening of the arteries, pouches in the colon and cysts in the kidneys, and 9% led to the individual receiving medical attention. Meanwhile, with MRI scans of the head, more than 40% showed defects, and 2% led to further assessment. By contrast, ultrasonography, plain-film radiography and nuclear medicine tests prompted no follow-ups. Only 1% of examinations with incidental findings led to follow-up procedures that clearly helped patients.
The study has obvious limitations. The authors did not determine, for example, whether diagnoses triggered by incidental findings led to better outcomes than clinical evaluations spurred by symptoms. And they didn't estimate the emotional impact on patients, or the costs of interventions.
In any case, paying radiologists to inspect study images on the off-chance may not be practical at non-medical research institutions, says Peter Bandettini, an expert in functional imaging at the National Institutes of Health in Bethesda, Maryland.
But knowing which tests most often uncover clinically important anomalies could help research committees to set guidelines and allocate resources, he adds. "But it's premature to have a standard overarching protocol, because the benefits of screening are still debated," says Bandettini.
References
1. Orme, N. M. et al. Arch. Intern. Med. 170, 1525-1532 (2010).
2. Illes, J. et al. Science 311, 783-784 (2006).
3. Wolf, S. M. et al. J. Law Med. Ethics 36, 219-248 (2008).
Orme NM, Fletcher JG, Siddiki HA, et al. Incidental Findings in Imaging Research: Evaluating Incidence, Benefit, and Burden. Arch Intern Med 2010;170(17):1525-32.
Background Little information exists concerning the frequency and medical significance of incidental findings (IFs) in imaging research.
Methods Medical records of research participants undergoing a research imaging examination interpreted by a radiologist during January through March 2004 were reviewed, with 3-year clinical follow-up. An expert panel reviewed all IFs generating clinical action to determine medical benefit/burden on the basis of predefined criteria. The frequency of IFs that generated further clinical action was estimated by modality, body part, age, and sex, along with net medical benefit or burden.
Results Of 1426 research imaging examinations, 567 (39.8%) had at least 1 IF (1055 total). Risk of an IF increased significantly by age (odds ratio [OR], 1.5; 95% confidence interval, 1.4-1.7 per decade increase). Abdominopelvic computed tomography generated more IFs than other examinations (OR, 18.9 vs ultrasonography; 9.2% with subsequent clinical action), with computed tomography of the thorax and magnetic resonance imaging of the head next (OR, 11.9 and 5.9; 2.8% and 2.2% with action, respectively). Of the 567 examinations with an IF, 35 (6.2%) generated clinical action, resulting in clear medical benefit in 1.1% (6 of 567) and clear medical burden in 0.5% (3 of 567). Medical benefit/burden was usually unclear (26 of 567 [4.6%]).
Conclusions Frequency of IFs in imaging research examinations varies significantly by imaging modality, body region, and age. Research imaging studies at high risk for generating IFs can be identified. Routine evaluation of research images by radiologists may result in identification of IFs in a high number of cases and subsequent clinical action to address them in a small but significant minority. Such clinical action can result in medical benefit to a small number of patients.
Lo B. Responding to Incidental Findings on Research Imaging Studies: Now What? Arch Intern Med 2010;170(17):1522-4.
