Improving Medical Communication in Migraine Management: A Modified Delphi Study to Develop a Digital Migraine Tracker.

OBJECTIVE: This study aimed to identify the essential content and amount of information to be collected from people with migraine via a patient-facing smartphone-based migraine tracker for them to share with clinicians during live discussions to assist in optimizing migraine management. The proposed tracker is intended for use in non-interventional research to evaluate disease burden in episodic migraine and chronic migraine patients as assessed by demographic and clinical characteristics and health resource utilization in an integrated delivery network setting. The proposed tracker is not intended for commercial purposes. BACKGROUND: Epidemiological studies suggest migraine is underdiagnosed and undertreated. Studies of patient-clinician interactions suggest that effective medical communication may help address these issues. METHODS: Four migraine practice leaders, an epidemiologist with extensive migraine experience, and a measurement expert took part in a modified Delphi panel process to identify data elements that could be collected from people with migraine through a smartphone-based migraine tracker. Importantly, the proposed tracker would not be intended to replace the patient-clinician encounter but to support the encounter through enabling the patient to document migraine symptoms and experiences in a timely and accurate manner for sharing with a clinician as part of a broader face-to-face discussion. The panel reviewed questions derived from the existing migraine diaries in the public domain, those used in clinical trials, and patient-centric surveys assessing the impact of migraine on physical function and other related concepts. Key considerations included identification of the most clinically useful data elements for a shared communication tool for people with migraine under the care of a clinician. The panel also identified numerous functionality requirements for such a tool and provided recommendations on the most effective way to present results to a clinician. RESULTS: The expert panel opined that people with migraine may value the ability to capture a relatively broad range of information for their own migraine-tracking purposes, while clinicians will likely find greater value in a small set of data relevant to the management of migraine. The panel identified the 3 most essential concepts in categories of data for a clinician, for which they coined the term "The 3 Fs": Frequency of days with headache; Frequency of acute medication usage; and Functional impairment. Information on the frequency of days with headache was felt to combine with the information on the frequency of acute medication usage to provide essential insights into current migraine management strategy and its outcomes, and to assist considerations of preventive measures. Functional impairment was treated as an effective surrogate for headache severity and was assessed based on the following: degree of difficulty in performing activities of daily living, impact on absenteeism (taking leave from work or cancelling/avoiding other activities) and presenteeism (performing work or other daily activities, with reduced productivity/capability), and amount of rest required as a result of a migraine attack. The modified Delphi panel process resulted in the selection of 13 questions in 8 categories to elicit sufficient and meaningful data comprising headache occurrence, symptoms, daily/preventive and as-needed/acute medication usage, triggers, ability to concentrate, and functional impairment. The panel also agreed that the tracker should generate 2 distinct reports: one for people with migraine that would include a wider range of data about symptoms and perceived triggers, and a targeted report for the clinician that would place prime emphasis on the 3 Fs for aggregating the results of each headache occurrence and the trend over time. CONCLUSIONS: A system that easily captures critical data elements about migraine, with specific feedback displays for patients to share with clinicians during live discussions, may offer some benefit to people with migraine and their clinicians by facilitating more objective communication and optimizing management. The tracker's output may enable people with migraine to track a wide range of data for their own purposes, allowing them to better understand their condition, while a synthesized view of the selected data may support more informed clinical decision-making for the clinician and individualized, evidence-based discussion with the patient. As a result, this shared decision-making tool may enable patients to more accurately convey essential migraine information during live patient-clinician discussions to drive improved management and patient outcomes.

Duplex imaging of the renal arteries with contrast enhancement.

Duplex ultrasound evaluation of the renal arteries is a technically challenging procedure. Its accuracy is significantly influenced by operator expertise and patient factors, such as overlying bowel gas and obesity. Intravenous microbubble contrast agents enhance vascular reflective acoustic signals and may improve ultrasound diagnostic accuracy. The clinical usefulness of such a contrast agent in the renal vasculature was examined prospectively. A total of 22 patients (16 males and 6 females) with mean age of 63 +/-3 years with suspected abdominal vascular disease were studied prospectively. A complete color flow duplex imaging study of the renal vasculature was performed. This was then followed by an identical examination during which an ultrasound contrast agent (Definity, DuPont Pharmaceutical) was infused intravenously at a rate of 2 to 4 mL/min. In addition to imaging of the vessels, the peak systolic velocity and Doppler waveforms of the aorta and renal arteries were examined. These results were independently compared to results with contrast angiography. A mean of 67 mL of contrast was used per patient. Of the total of 43 renal arteries examined, the accuracy for the detection of occlusions was 75% (3 of 4) for both standard and contrast-enhanced duplex ultrasound. The accuracy for the detection of hemodynamically significant stenosis was 50% (6 of 12) for standard and 75% (9 of 12) for contrast-enhanced duplex ultrasound. Visualization of normal or minimally diseased arteries was 94% (30 of 32) for standard and 97% (31 of 32) for contrast-enhanced ultrasound. Although overall accuracy was not enhanced by the infusion of ultrasound contrast, 5 of 7 arteries not visualized by color flow duplex were detected following the infusion of contrast agent, resulting in an additional 10% (5 of 48) of vessels visualized. Peak systolic velocities were increased by an average of 10% in normal or minimally diseased vessels and 12% in stenotic vessels following contrast administration but these differences were not statistically significant. Contrast-enhanced duplex imaging of the renal arteries is safe but not routinely required when performed by an experienced sonographer. However, it may increase visualization and accuracy in patients with stenoses or when the vessels are not initially visualized. Although increased velocities are seen when contrast agent is used, this does not appear to necessitate different Doppler criteria at this time.

Contrast enhanced duplex ultrasound imaging of the mesenteric arteries.

Duplex ultrasound of the visceral arteries is a technically challenging procedure. We examined the clinical usefulness of perflutren intravenous ultrasound contrast to improve the diagnostic accuracy of such studies. Seventeen patients were prospectively studied. A color duplex imaging study of the visceral vasculature was performed with and without the contrast agent. Vessels were imaged and peak systolic velocity and Doppler waveforms of the aorta, celiac artery, superior mesenteric artery, and the inferior mesenteric artery were examined. These results were independently compared to those of contrast angiography. From this analysis we concluded contrast-enhanced duplex imaging of the mesenteric arteries is safe but not routinely required when performed by an experienced sonographer. Ultrasound contrast may be helpful in difficult patients when the vessels are not initially successfully visualized.