We wish to thank the Jason Cruickshank, Bob Gray, and the Cleveland Clinic Athletic Trainers for their support and assistance with data collection. This study was supported by the Edward F. and Barbara A. Bell Family Endowed Chair to JLA.

The protocol outlined below follows the guidelines of the Cleveland Clinic human research ethics committee.
1. Administering the C3 App
<ol>
	<li>Administer the C3 app to all student-athletes at baseline prior to the start of the given athletic season. Administer follow up assessments in the event of a concussive injury. Follow up assessments are reserved for the evaluation of recovery once the individual reports no more than minimal symptoms, so as to prevent symptom provocation as a result of testing. The following protocol is used when administering the C3 app.</li>
	<li>Assess postural sway during performance of the Balance Error Scoring System (BESS) using the inertial sensors native to the digital tablet to collect biomechanical data measuring linear and angular acceleration while the student-athlete completes six 20-second balance stances.</li>
	<li>Ensure that the volume is turned up. Ask the athlete to remove his/her shoes.</li>
	<li>Ask and record the following information:
	<ol>
		<li>&#34;If you were to kick a ball, what leg would you use?&#34;. Record individual&#39;s answer as their &#34;dominant foot&#34;.</li>
		<li>&#8220;Have you had an ankle or knee injury from which you haven&#39;t fully recovered in the last six months?&#8221; Record if injury affected dominant or non-dominant ankle or knee.</li>
		<li>Record if the athlete is wearing any sort of brace on his/her dominant or non-dominant knee or ankle.</li>
		<li>Record the surface on which the testing is being conducted.</li>
		<li>Record the footwear used for testing (socks are preferred).</li>
	</ol>
	</li>
	<li>Affix digital tablet onto individual&#39;s sacrum using a custom belt.</li>
	<li>Inform athlete that his/her balance will be tested. Instruct athlete to remain in the designated stance for the entire 20-second trial with his/her hands on hips and eyes closed. Instruct the athlete to get back into the correct position as quickly as possible if he/she loses his/her balance. Verify that the athlete understands the instructions, and ask him/her to stand with his/her feet together (demonstrate double limb stance, Figure 2a).
	<ol>
		<li>Once the athlete is in the proper stance, tap Start to begin the 5-second countdown that signalizes the start of the 20-second trial.</li>
		<li>During the 20-second trial, count the number of errors committed. Errors include any of the following: Hands off hips; opening eyes; step, stumble, or fall; lifting toe or heel off the ground; bending more than 30 degrees at the waist; staying out of position for greater than 5 seconds.</li>
		<li>Record the number of errors committed during the balance trial.</li>
	</ol>
	</li>
	<li>For the second trial, instruct athlete to stand on his/her non-dominant foot (Figure 2b). Repeat steps 1.4.1 to 1.4.3.</li>
	<li>For the third trial, instruct athlete to stand heel to toe in tandem stance, with the non-dominant foot in the back (Figure 2c). Repeat steps 1.4.1 to 1.4.3.</li>
	<li>For the fourth trial, instruct athlete to stand with feet together, identical to the first stance, but on a foam pad, (Figure 2d). Repeat steps 1.4.1 to 1.4.3.</li>
	<li>For the fifth trial, instruct athlete to stand on his/her non-dominant foot, identical to the second trial, but on a foam pad (Figure 2e). Repeat steps 2.4.1 to 2.4.3.</li>
	<li>For the sixth trial, instruct athlete to stand stand heel to toe in tandem stance identical to the third trial, but on a foam pad (Figure 2f). Repeat steps 2.4.1 to 2.4.3.</li>
</ol>
2. Assessment of Static and Dynamic Vision
<ol>
	<li>Static Vision
	<ol>
		<li>Use the length of the belt to measure 5 feet to position the digital tablet and participant at the correct distance, 5 feet apart.</li>
		<li>Holding the digital tablet at eye level, instruct the participant to read the 5 letters displayed from left to right (refer to instructions as shown in Figure 3).</li>
		<li>Record the correct number of letters the participant was able to read.</li>
		<li>If the participant correctly identified 3 or more letters, repeat steps 2.1.2 and 2.1.3 once smaller optotypes are presented.</li>
		<li>If the participant identifies 2 or fewer correctly, proceed to step 2.2.</li>
	</ol>
	</li>
	<li>Dynamic Vision
	<ol>
		<li>Play the sample metronome tone and demonstrate proper head movement, rotating right to left, approximately 20 degrees of cervical rotation in each direction (envisioning movement from 10 to 2 on a horizontal clock dial). Ask the participant to demonstrate the proper head rotation, keeping with the metronome.</li>
		<li>Initiate trial, ensure participant is rotating head properly while optotypes are presented. Instruct participant to read the 5 letters displayed from left to right while continuing to rotate head left to right to the beat of the metronome. If the participant stops moving his/her head to read the letters, press Redo Trial.</li>
		<li>Record the correct number of letters the participant was able to read.</li>
		<li>If the participant correctly identified 3 or more letters, repeat steps 2.2.2 and 2.2.3 once smaller optotypes are presented.</li>
		<li>If the participant identifies 2 or fewer correctly, proceed to next module.</li>
	</ol>
	</li>
</ol>
3. Assessment of Information Processing Assessment using Simple and Choice Reaction Time Paradigms14
<ol>
	<li>Simple Reaction Time (SRT) (Figure 4a)
	<ol>
		<li>Display the instruction screen and instruct the participant to place his/her index finger from the dominant hand on the Touch and Hold button. Once the stimulus (light) turns from yellow to green, instruct the participant to release the button and touch the green light as quickly as possible.</li>
		<li>Observe the participant complete the practice trial, ensuring that he/she understands the directions and is able to complete the task within the allotted time (100-500 ms).</li>
		<li>Observe the participant complete 25 valid trials without errors within the allotted time (100-500 ms per trial).</li>
	</ol>
	</li>
	<li>Choice Reaction Time (CRT) (Figure 4b)
	<ol>
		<li>Display the instruction screen and ask participant to place both index fingers on Touch and Hold buttons.</li>
		<li>After the yellow light is displayed momentarily, a green light (stimulus) and cyan light, serving as a distractor light, are displayed. Ask participant to lift the digit that corresponds with the side in which the green light was presented, and tap the green light as quickly as possible. Remind the participant to keep the digit that corresponds to the cyan distractor light on the Touch and Hold button.</li>
		<li>Observe the participant complete practice trial, ensuring that he/she understands the directions and is able to complete task within the allotted time (100-750 ms).</li>
		<li>Observe the participant complete 25 valid trials without errors within the allotted time (100-750* ms per trial). 
		NOTE: The 500 ms and 750 ms restrictions for SRT and CRT, respectively are lifted post-injury for follow up assessments.</li>
	</ol>
	</li>
</ol>
4. Processing Speed Test15
<ol>
	<li>Initiate the test and instruct the participant to read the instructions provided on the sample testing screen. Instruct the participant to use the symbol key on the top of the screen to complete the test below the symbol key. The symbol key contains symbols in the top row and corresponding digits in the bottom row. The test contains only symbols, requiring the participant to input digits that correspond to the symbol as identified in the key using the keyboard at the bottom of the screen.</li>
	<li>Press the Begin Practice button and observe the participant complete the practice trial according to proper testing procedures.</li>
	<li>Remind participant that the actual test will not provide feedback as to whether the response was &#8220;correct&#8221; or &#8220;incorrect&#8221;, as it did in the practice trial.</li>
	<li>Inform the participant that a new row of symbols will appear once he/she completes the existing row. Instruct the participant to continue to enter corresponding digits until prompted to stop and that the trial will last 2 minutes. Remind the participant that he/she cannot correct an incorrect response, and to complete each response as quickly and accurately as possible.</li>
	<li>Press the Begin Test button to initiate the test. Observe the participant perform the test ensuring correct procedures are followed (Figure 5).</li>
</ol>
5. Assessment of Executive Function and Set Switching
<ol>
	<li>Trail Making Test A
	<ol>
		<li>Instruct participant to read the instructions on the screen, describing the test as a &#8220;connect the dots&#8221; test in which 25 circles corresponding with digits 1-25 must be connected by using the stylus provided (Figure 6a).</li>
		<li>Press Begin Practice and observe participant completing the practice trial, ensuring that he/she maintains contact between the digital tablet and stylus throughout the trial.</li>
		<li>Proceed to test by pressing the Begin Test button. Observe the participant complete the test, ensuring that correct procedures are followed (Figure 6b).</li>
	</ol>
	</li>
	<li>Trail Making Test B
	<ol>
		<li>Instruct participant to read the instructions on the screen, describing the test as a &#8220;connect the dots&#8221; test in which 25 circles corresponding with digits and letters must be connected using the stylus provided. Instruct the participant to begin with the number &#8220;1&#8221;, followed by the letter &#8220;A&#8221;, and continue alternating between numbers and letters, in sequence, &#8220;1&#8221; followed by &#8220;A&#8221;, then &#8220;2&#8221; followed by &#8220;B&#8221;, then &#8220;3&#8221; followed by &#8220;C&#8221;, etc. The test is complete when 25 dots corresponding with numbers and letters are connected.</li>
		<li>Press Begin Practice and observe participant completing the practice trial, ensuring that he/she maintains contact between the digital tablet and stylus throughout the trial (Figure 6c).</li>
		<li>Proceed to test by pressing Begin Test button. Observe the participant complete the test, ensuring that correct procedures are followed (Figure 6d).</li>
	</ol>
	</li>
</ol>
6. Interpretation of C3 App to Guide Clinical Decision-Making
<ol>
	<li>Administer C3 app follow-up assessment if the student-athlete is diagnosed with a concussion20 using procedures outlined in step 1 above. Ensure clearance of cervical spine prior to administration of dynamic visual testing.</li>
	<li>View follow-up performance on all C3 app modules as displayed in Figure 7.</li>
	<li>Determine post-injury performance on radar plot by analyzing each axis (representing a given module) relative to baseline performance, represented by the perimeter of the polygon. The red, yellow, and blue polygons depict performance at various post-injury time points, representing a gradual return to baseline function.</li>
	<li>Based on the clinical exam, performance on C3 app modules, time since injury, athlete&#8217;s history, and other relevant determinants of care, refer to specialty services as outlined in carepath algorithm (Figure 1).</li>
	<li>Field Validation
	<ol>
		<li>Conduct an analysis of C3 app data on a cohort of student-athletes with confirmed concussion. With Cleveland Clinic Institutional Review Board approval and waived consent, C3 app data were obtained for all incident reports completed between July, 2014 through October, 2016, and C3 baseline and follow up assessments completed on student-athletes injured between July, 2013 through December, 2014. Criteria for inclusion were as follows: 1) Presence of baseline C3 assessment, 2) Concussive injury confirmed by Cleveland Clinic physician, 3) Follow-up C3 assessment post-injury.</li>
		<li>Determine post-injury performance on each module of the C3 app by comparing outcomes to baseline performance.
		<ol>
			<li>Analyze data as a function of post-injury phase as defined by the carepath: acute (0-7 days post-injury), subacute (8-20 days post-injury), chronic (&#62;20 days post-injury).</li>
			<li>Stratify student-athletes according to time to recovery (recovered within 3 weeks of injury or recovered in &#62;3 weeks since injury).</li>
		</ol>
		</li>
	</ol>
	</li>
</ol>

<ol>
	<li>Porter, M. E., Pabo, E. A., Lee, T. H. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Redesigning+primary+care:+a+strategic+vision+to+improve+value+by+organizing+around+patients'+needs.">Redesigning primary care: a strategic vision to improve value by organizing around patients' needs.</a> Health Affairs (Millwood). 32 (3), 516-525 (2013).</li><li>Porter, M. E., Lee, T. H. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+Strategy+That+Will+Fix+Health+Care.">The Strategy That Will Fix Health Care.</a> Harvard Business Review. 91 (12), 24-24 (2013).</li><li>Katzan, I. L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Electronic+Stroke+CarePath:+Integrated+Approach+to+Stroke+Care.">Electronic Stroke CarePath: Integrated Approach to Stroke Care.</a> Circulation: Cardiovascular Quality and Outcomes. 8, S179-S189 (2015).</li><li>Vanhaecht, K., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Development+and+validation+of+a+care+process+self-evaluation+tool.">Development and validation of a care process self-evaluation tool.</a> Health Service Management Research. 20 (3), 189-202 (2007).</li><li>Faul, M., Xu, L., Wald, M. M., Coronado, V. G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations and Deaths, 2002-2006. , 2002-2006 (2010).</li><li>McCrory, P., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Consensus+statement+on+concussion+in+sport-the+5th+international+conference+on+concussion+in+sport+held+in+Berlin,+October+2016.">Consensus statement on concussion in sport-the 5th international conference on concussion in sport held in Berlin, October 2016.</a> British journal of sports medicine. 51, 838-847 (2017).</li><li>McCrea, M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Incidence,+clinical+course,+and+predictors+of+prolonged+recovery+time+following+sport-related+concussion+in+high+school+and+college+athletes.">Incidence, clinical course, and predictors of prolonged recovery time following sport-related concussion in high school and college athletes.</a> Journal of the International Neuropsychological Society. 19 (1), 22-33 (2013).</li><li>Broglio, S. P., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=National+Athletic+Trainers'+Association+position+statement:+management+of+sport+concussion.">National Athletic Trainers' Association position statement: management of sport concussion.</a> Journal of athletic training. 49 (2), 245-265 (2014).</li><li>Harmon, K. G., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=American+medical+society+for+sports+medicine+position+statement:+concussion+in+sport.">American medical society for sports medicine position statement: concussion in sport.</a> Clinical Journal of Sports Medicine. 23 (1), 1-18 (2013).</li><li>Giza, C. C., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Summary+of+evidence-based+guideline+update:+Evaluation+and+management+of+concussion+in+sports:+Report+of+the+Guideline+Development+Subcommittee+of+the+American+Academy+of+Neurology.">Summary of evidence-based guideline update: Evaluation and management of concussion in sports: Report of the Guideline Development Subcommittee of the American Academy of Neurology.</a> Neurology. , (2013).</li><li>Alberts, J. L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+Multidisciplinary+Approach+to+Concussion+Management.">A Multidisciplinary Approach to Concussion Management.</a> The Bridge. 46 (1), 23-25 (2016).</li><li>Alberts, J. L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Using+Accelerometer+and+Gyroscopic+Measures+to+Quantify+Postural+Stability.">Using Accelerometer and Gyroscopic Measures to Quantify Postural Stability.</a> Journal of athletic training. 50 (6), 578-588 (2015).</li><li>Alberts, J. L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Quantification+of+the+Balance+Error+Scoring+System+with+Portable+Technology.">Quantification of the Balance Error Scoring System with Portable Technology.</a> Medicine and Science in Sport and Exercise. 47 (10), 2233-2240 (2015).</li><li>Burke, D., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Characterizing+Information+Processing+With+a+Mobile+Device:+Measurement+of+Simple+and+Choice+Reaction+Time.">Characterizing Information Processing With a Mobile Device: Measurement of Simple and Choice Reaction Time.</a> Assessment. , (2016).</li><li>Rudick, R. A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+Multiple+Sclerosis+Performance+Test+(MSPT),+an+iPad-based+disability+assessment+tool.">The Multiple Sclerosis Performance Test (MSPT), an iPad-based disability assessment tool.</a> Journal of Visual Experiments. 2014 (88), e51318 (2014).</li><li>Ozinga, S. J., Alberts, J. L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Quantification+of+postural+stability+in+older+adults+using+mobile+technology.">Quantification of postural stability in older adults using mobile technology.</a> Experimental brain research. 232 (12), 3861-3872 (2014).</li><li>Alberts, J., Linder, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+utilization+of+biomechanics+to+understand+and+manage+the+acute+and+long-term+effects+of+concussion.">The utilization of biomechanics to understand and manage the acute and long-term effects of concussion.</a> Kinesiology Review. 4, 39-51 (2015).</li><li>Simon, M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Reliability+and+Concurrent+Validity+of+Select+C3+Logix+Test+Components.">Reliability and Concurrent Validity of Select C3 Logix Test Components.</a> Developmental Neuropsychology. , 1-14 (2017).</li><li>Bernstein, J. P. K., Calamia, M., Pratt, J., Mullenix, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Assessing+the+effects+of+concussion+using+the+C3Logix+Test+Battery:+An+exploratory+study.">Assessing the effects of concussion using the C3Logix Test Battery: An exploratory study.</a> Applied Neuropsychology Adult. , 1-8 (2018).</li><li>McCrory, P., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Consensus+statement+on+concussion+in+sport:+the+4th+International+Conference+on+Concussion+in+Sport+held+in+Zurich,+November+2012.">Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012.</a> British Journal of Sports Medicine. 47 (5), 250-258 (2012).</li><li>Foundation ON. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Concussion Care and Recovery Pathway. , (2018).</li><li>Vander Vegt, C., Register-Mihalik, J., Ford, C., Rodrigo, C., Guskiewicz, K., Mihalik, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Baseline+Concussion+Clinical+Measures+Are+Related+to+Sensory+Organization+and+Balance.">Baseline Concussion Clinical Measures Are Related to Sensory Organization and Balance.</a> Medicine and science in sports and exercise. , (2018).</li></ol>

Drs. Alberts and Linder have filed intellectual property protecting the Cleveland Clinic Concussion mobile application. The remaining authors have nothing to disclose.

The development and implementation of the concussion carepath served numerous purposes in our health system&#39;s transformation toward value-based care1,2,3. The algorithm of care was critical in guiding clinical decision-making, and was supported by standardized, biomechanical outcomes in the form of the C3 app, which was used by all members of the interdisciplinary concussion team. These standardized outcomes provided qualifi...

The practice of medicine and the delivery of health care are undergoing a fundamental transformation from volume to value1, driven by payers, hospitals, clinicians, and patients. Health care delivery is challenged by the lack of standardization, interoperability of systems, communication of information, and the coordination of services. These deficiencies complicate effective continuity of care that often result in unnecessary services and have been identified as primary sources of rising health care costs1,2. By contrast, coordinated disease- or condition-specific care has been shown to optimize outcomes while minimizing costs2. In a coordinated care model, patients with a given condition are managed by an experienced, interdisciplinary team according to best practice guidelines, and are referred to the right provider at the right time2.
In efforts to transform clinical practice from a primarily volume-based to a value-based model, the Cleveland Clinic embarked on an enterprise-wide initiative to standardize clinical practice along disease lines through the development and implementation of clinical carepaths3. A care pathway is defined as a standardized approach for the mutual decision-making and organization of care processes for a well-defined group of patients over a well-defined time4. The underlying tenet of a care pathway is standardization of care. The expectation is that with evidence-based care pathways and interdisciplinary care teams, standardization and best practice will be achieved over time, venue and provider resulting in improved efficiency, effectiveness, and value2. With the inclusion of validated outcomes, there is a built-in mechanism for iterating the carepath over time to further refine and improve patient care.
Concussion was identified as a condition in which the potential to streamline care and optimize patient management was significant. While concussive injuries are typically not life-threatening, their effects can be severe and debilitating, with direct and indirect costs estimated at $83 billion annually5. It is estimated that 80-90% of individuals with concussion recover within 7-14 days of injury6,7. However, consensus on the management of the 10-20% of individuals with persistent symptoms is lacking, and evidence supporting or refuting the efficacy of rehabilitation, medical interventions or the diagnostic value of imaging in individuals with post-concussive symptoms is sparse. Multiple consensus statements indicate that an interdisciplinary team approach is optimal to treat concussion6,8,9,10. In 2011, work on the Cleveland Clinic Concussion Carepath11, shown in Figure 1, was initiated. Our primary goal was to create a standardized, evidence-informed approach to the identification, evaluation and management of individuals with concussion. An interdisciplinary team of providers collaborated in the development of the carepath, building consensus based on available evidence in the literature and expert clinical opinion. Physician groups that were represented included: sports medicine, neurology, neurosurgery, rehabilitation medicine, neuroradiology, emergency medicine, primary care, pediatrics and family medicine. The carepath team also included athletic trainers (AT&#39;s), physical therapists (PT&#39;s), speech therapists, occupational therapists, nurses, and neuropsychologists. Finally, computer scientists and research scientists provided technical guidance and software development. The carepath algorithm, documentation template, and outcomes were developed over a course of 15 months from 2011 to 2012. To ensure appropriateness of outcome measures, the C3 application assessment modules were simultaneously being validated12,13,14,15,16.
The evidence-based Cleveland Clinic concussion carepath depicted in Figure 1 was developed to identify individuals with concussion on a trajectory of typical and delayed recovery, and specifically for the latter group, to create clear and objective criteria for referral to specialty services. Standardized outcome measures were established and proposed to be collected across disciplines. In an effort to facilitate utilization and compliance with the standardized evaluation and documentation requirements of the carepath, the Cleveland Clinic Concussion (C3) app was developed, tested, and deployed. The aim of this project is to 1) describe the development and implementation of the Concussion Carepath, 2) to demonstrate the integration of technology in the form of a mobile application to enable the carepath and guide clinical decision-making, and 3) to present preliminary data on the responsiveness of the C3 app in detecting change in neurological function post-concussion. We hypothesized that utilizing the C3 app would improve interdisciplinary communication aide in clinical decision making.

<table border="0" cellpadding="0" cellspacing="0" style="width:680px;" width="681">
	<tbody>
		<tr height="63">
			<td height="63" style="height:63px;width:216px;">Foam Balance Pad</td>
			<td style="width:159px;">Airex, Sins, Switzerland</td>
			<td style="width:139px;"></td>
			<td style="width:167px;">dense foam balance pad used during balance testing</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;">iPad Digital Table</td>
			<td style="width:159px;">Apple</td>
			<td style="width:139px;"></td>
			<td></td>
		</tr>
	</tbody>
</table>

development and implementation of a multi-disciplinary technology enhanced care pathway for youth and adults with concussion

The evidence-informed standardization of care along disease lines is recommended to improve outcomes and reduce healthcare costs. The aim of this project is to 1) describe the development and implementation of the Concussion Carepath, 2) demonstrate the process of integrating technology in the form of a mobile application to enable the carepath and guide clinical decision-making, and 3) present data on the utility of the C3 app in facilitating decision-making throughout the injury recovery process. A multi-disciplinary team of experts in concussion care was formed to develop an evidence-informed algorithm, outlining best practices for the clinical management of concussion along three phases of recovery &#8211; acute, subacute, and post-concussive. A custom mobile application, the Cleveland Clinic Concussion (C3) app was developed and validated to provide a platform for the systematic collection of objective, biomechanical outcomes and to provide guidance in clinical decision-making in the field and clinical environments. The Cleveland Clinic Concussion app included an electronic incident report, assessment modules to measure important aspects of cognitive and motor function, and a return to play module to systematically document the six phases of post-injury rehabilitation. The assessment modules served as qualifiers within the carepath algorithm, driving referral for specialty services as indicated. Overall, the carepath coupled with the C3 app functioned in unison to facilitate communication among the interdisciplinary team, prevent stagnant care, and drive patients to the right provider at the right time for efficient and effective clinical management.

To investigate change in neurologic function following concussion, baseline and follow-up C3 assessments were analyzed in 181 student-athletes injured during the 2013-2014 athletic seasons. Detailed demographics of the 181 injured athletes are shown in Table 1. Data were stratified into two groups: those who recovered within three weeks of injury (N=92) and those who were still symptomatic three weeks after injury (N=89). When comparing the first post-injury assessments, ...

Watch this Scientific Journal Video about Development and Implementation of a Multi-Disciplinary Technology Enhanced Care Pathway for Youth and Adults with Concussion at JoVE.com

Development and Implementation of a Multi-Disciplinary Technology Enhanced Care Pathway for Youth and Adults with Concussion

A multidisciplinary carepath to standardize disparate concussion care was developed and implemented at the Cleveland Clinic. The Cleveland Clinic Concussion (C3) mobile application was used to enable the carepath through biomechanical outcomes characterizing cognitive and motor function. Patient outcomes improved while cost of care was reduced following implementation.

The evidence-informed standardization of care along disease lines is recommended to improve outcomes and reduce healthcare costs. The aim of this project ...

development-implementation-multi-disciplinary-technology-enhanced

Research

JoVE Journal

Medicine

6.4K Views.  Cleveland Clinic Foundation. A multidisciplinary carepath to standardize disparate concussion care was developed and implemented at the Cleveland Clinic. The Cleveland Clinic Concussion (C3) mobile application was used to enable the carepath through biomechanical outcomes characterizing cognitive and motor function. Patient outcomes improved while cost of care was reduced following implementation. 

Video: Development and Implementation of a Multi-Disciplinary Technology Enhanced Care Pathway for Youth and Adults with Concussion

An Investigation of the Effects of Sports-related Concussion in Youth Using Functional Magnetic Resonance Imaging and the Head Impact Telemetry System

One of the most commonly reported injuries in children who participate in sports is concussion or mild traumatic brain injury (mTBI)1. Children and youth involved in organized sports such as competitive hockey are nearly six times more likely to suffer a severe concussion compared to children involved in other leisure physical activities2. While the most common cognitive sequelae of mTBI appear similar for children and adults, the recovery profile and breadth of consequences in children remains largely unknown2, as does the influence of pre-injury characteristics (e.g. gender) and injury details (e.g. magnitude and direction of impact) on long-term outcomes. Competitive sports, such as hockey, allow the rare opportunity to utilize a pre-post design to obtain pre-injury data before concussion occurs on youth characteristics and functioning and to relate this to outcome following injury. Our primary goals are to refine pediatric concussion diagnosis and management based on research evidence that is specific to children and youth. To do this we use new, multi-modal and integrative approaches that will:
 1.Evaluate the immediate effects of head trauma in youth 
2.Monitor the resolution of post-concussion symptoms (PCS) and cognitive performance during recovery 
3.Utilize new methods to verify brain injury and recovery
To achieve our goals, we have implemented the Head Impact Telemetry (HIT) System. (Simbex; Lebanon, NH, USA). This system equips commercially available Easton S9 hockey helmets (Easton-Bell Sports; Van Nuys, CA, USA) with single-axis accelerometers designed to measure real-time head accelerations during contact sport participation 3 - 5. By using telemetric technology, the magnitude of acceleration and location of all head impacts during sport participation can be objectively detected and recorded. We also use functional magnetic resonance imaging (fMRI) to localize and assess changes in neural activity specifically in the medial temporal and frontal lobes during the performance of cognitive tasks, since those are the cerebral regions most sensitive to concussive head injury 6. Finally, we are acquiring structural imaging data sensitive to damage in brain white matter.

This article provides an overview of a multi-modal approach to mild traumatic brain injury diagnosis and recovery in youth. This approach combines neuropsychological testing with functional magnetic resonance imaging and the Head Impact Telemetry System to monitor the relationship between head impacts and brain activity during cognitive testing.

One of the most commonly reported injuries in children who participate in sports is concussion or mild traumatic brain injury (mTBI)1. Children and youth ...

Using Visual and Narrative Methods to Achieve Fair Process in Clinical Care

The Institute of Medicine has targeted patient-centeredness as an important area of quality improvement. A major dimension of patient-centeredness is respect for patient's values, preferences, and expressed needs. Yet specific approaches to gaining this understanding and translating it to quality care in the clinical setting are lacking. From a patient perspective quality is not a simple concept but is best understood in terms of five dimensions: technical outcomes; decision-making efficiency; amenities and convenience; information and emotional support; and overall patient satisfaction. Failure to consider quality from this five-pronged perspective results in a focus on medical outcomes, without considering the processes central to quality from the patient's perspective and vital to achieving good outcomes. In this paper, we argue for applying the concept of fair process in clinical settings. Fair process involves using a collaborative approach to exploring diagnostic issues and treatments with patients, explaining the rationale for decisions, setting expectations about roles and responsibilities, and implementing a core plan and ongoing evaluation. Fair process opens the door to bringing patient expertise into the clinical setting and the work of developing health care goals and strategies. This paper provides a step by step illustration of an innovative visual approach, called photovoice or photo-elicitation, to achieve fair process in clinical work with acquired brain injury survivors and others living with chronic health conditions. Applying this visual tool and methodology in the clinical setting will enhance patient-provider communication; engage patients as partners in identifying challenges, strengths, goals, and strategies; and support evaluation of progress over time. Asking patients to bring visuals of their lives into the clinical interaction can help to illuminate gaps in clinical knowledge, forge better therapeutic relationships with patients living with chronic conditions such as brain injury, and identify patient-centered goals and possibilities for healing. The process illustrated here can be used by clinicians, (primary care physicians, rehabilitation therapists, neurologists, neuropsychologists, psychologists, and others) working with people living with chronic conditions such as acquired brain injury, mental illness, physical disabilities, HIV/AIDS, substance abuse, or post-traumatic stress, and by leaders of support groups for the types of patients described above and their family members or caregivers.

This paper illustrates an innovative visual approach (photovoice or photo-elicitation) to achieve fair process in clinical care for patients living with chronic health conditions, illuminate gaps in clinical knowledge, forge better therapeutic relationships, and identify patient-centered goals and possibilities for healing.

The Institute of Medicine has targeted patient-centeredness as an important area of quality improvement. A major dimension of patient-centeredness is ...

Development of an Audio-based Virtual Gaming Environment to Assist with Navigation Skills in the Blind

Audio-based Environment Simulator (AbES) is virtual environment software designed to improve real world navigation skills in the blind. Using only audio based cues and set within the context of a video game metaphor, users gather relevant spatial information regarding a building's layout. This allows the user to develop an accurate spatial cognitive map of a large-scale three-dimensional space that can be manipulated for the purposes of a real indoor navigation task. After game play, participants are then assessed on their ability to navigate within the target physical building represented in the game. Preliminary results suggest that early blind users were able to acquire relevant information regarding the spatial layout of a previously unfamiliar building as indexed by their performance on a series of navigation tasks. These tasks included path finding through the virtual and physical building, as well as a series of drop off tasks. We find that the immersive and highly interactive nature of the AbES software appears to greatly engage the blind user to actively explore the virtual environment. Applications of this approach may extend to larger populations of visually impaired individuals.

Audio-based Environment Simulator (AbES) is virtual environment software designed to improve real world navigation skills in the blind.

Audio-based Environment Simulator (AbES) is virtual environment software designed to improve real world navigation skills in the blind. Using only audio ...

Collecting Saliva and Measuring Salivary Cortisol and Alpha-amylase in Frail Community Residing Older Adults via Family Caregivers

Salivary measures have emerged in bio-behavioral research that are easy-to-collect, minimally invasive, and relatively inexpensive biologic markers of stress. This article we present the steps for collection and analysis of two salivary assays in research with frail, community residing older adults-salivary cortisol and salivary alpha amylase. The field of salivary bioscience is rapidly advancing and the purpose of this presentation is to provide an update on the developments for investigators interested in integrating these measures into research on aging. Strategies are presented for instructing family caregivers in collecting saliva in the home, and for conducting laboratory analyses of salivary analytes that have demonstrated feasibility, high compliance, and yield quality specimens. The protocol for sample collection includes: (1) consistent use of collection materials; (2) standardized methods that promote adherence and minimize subject burden; and (3) procedures for controlling certain confounding agents. We also provide strategies for laboratory analyses include: (1) saliva handling and processing; (2) salivary cortisol and salivary alpha amylase assay procedures; and (3) analytic considerations.

We demonstrate: (1) procedures for collection of salivary samples in cognitive impaired older adults by family caregivers in the home setting, (2) procedures for measuring stress activity via salivary cortisol and alpha amylase, and (3) representative profiles. Protocols that allow researchers to study stress-linked processes advance our understanding of biological sensitivity and susceptibility.

Salivary measures have emerged in bio-behavioral research  that are easy-to-collect, minimally invasive, and relatively inexpensive  biologic markers of ...

Clinical Assessment of Spatiotemporal Gait Parameters in Patients and Older Adults

Spatial and temporal characteristics of human walking are frequently evaluated to identify possible gait impairments, mainly in orthopedic and neurological patients1-4, but also in healthy older adults5,6. The quantitative gait analysis described in this protocol is performed with a recently-introduced photoelectric system (see&#160;Materials table) which has the potential to be used in the clinic because it is portable, easy to set up (no subject preparation is required before a test), and does not require maintenance and sensor calibration. The photoelectric system consists of series of high-density floor-based photoelectric cells with light-emitting and light-receiving diodes that are placed parallel to each other to create a corridor, and are oriented perpendicular to the line of progression7. The system simply detects interruptions in light signal, for instance due to the presence of feet within the recording area. Temporal gait parameters and 1D spatial coordinates of consecutive steps are subsequently calculated to provide common gait parameters such as step length, single limb support and walking velocity8, whose validity against a criterion instrument has recently been demonstrated7,9. The measurement procedures are very straightforward; a single patient can be tested in less than 5 min&#160;and a comprehensive report can be generated in less than 1&#160;min.

This protocol is used to evaluate spatial and temporal gait variables of neurological/orthopedic patients and older persons by means of a recently-introduced floor-based photocell system.

Spatial and temporal characteristics of human walking are frequently evaluated to identify possible gait impairments, mainly in orthopedic and ...

A Multi-Modal Approach to Assessing Recovery in Youth Athletes Following Concussion

Concussion is one of the most commonly reported injuries amongst children and youth involved in sport participation. Following a concussion, youth can experience a range of short and long term neurobehavioral symptoms (somatic, cognitive and emotional/behavioral) that can have a significant impact on one&#8217;s participation in daily activities and pursuits of interest (e.g., school, sports, work, family/social life, etc.). Despite this, there remains a paucity in clinically driven research aimed specifically at exploring concussion within the youth sport population, and more specifically, multi-modal approaches to measuring recovery. This article provides an overview of a novel and multi-modal approach to measuring recovery amongst youth athletes following concussion. The presented approach involves the use of both pre-injury/baseline testing and post-injury/follow-up testing to assess performance across a wide variety of domains (post-concussion symptoms, cognition, balance, strength, agility/motor skills and resting state heart rate variability). The goal of this research is to gain a more objective and accurate understanding of recovery following concussion in youth athletes (ages 10-18 years). Findings from this research can help to inform the development and use of improved approaches to concussion management and rehabilitation specific to the youth sport community.

This article provides an overview of a multi-modal approach to assessing recovery following concussion in youth athletes. The described protocol uses pre- and post-concussion assessment of performance across a wide variety of domains and can inform the development of improved concussion rehabilitation protocols specific to the youth sport community.

Concussion is one of the most commonly reported injuries amongst children and youth involved in sport participation. Following a concussion, youth can ...

Autonomic Function Following Concussion in Youth Athletes: An Exploration of Heart Rate Variability Using 24-hour Recording Methodology

Participation in organized sports makes a significant contribution to youth development, but places youth at a higher risk for sustaining a concussion. To date, return-to-activity decision-making has been anchored in the monitoring of self-reported concussion symptoms and neurocognitive testing. However, multi-modal assessments that corroborate objective physiological measures with traditional subjective symptom reporting are needed and can be valuable. Heart rate variability (HRV) is a non-invasive physiological indicator of the autonomic nervous system, capturing the reciprocal interplay between the sympathetic and parasympathetic nervous systems. There is a dearth of literature exploring the effect of concussion on HRV in youth athletes, and developmental differences preclude the application of adult findings to a pediatric population. Further, the current state of HRV methodology has primarily included short-term (5-15 min) recordings, by using resting state or short-term physical exertion testing to elucidate changes following concussion. The novelty in utilizing a 24 h&#160;recording methodology is that it has the potential to capture natural variation in autonomic function, directly related to the activities a youth athlete performs on a regular basis. Within a prospective, longitudinal research setting, this novel approach to quantifying autonomic function can provide important information regarding the recovery trajectory, alongside traditional self-report symptom measures. Our objectives regarding a 24 h recording methodology were to (1) evaluate the physiological effects of a concussion in youth athletes, and (2) describe the trajectory of physiological change, while considering the resolution of self-reported post-concussion symptoms. To achieve these objectives, non-invasive sensor technology was implemented. The raw beat-to-beat time intervals captured can be transformed to derive time domain and frequency domain measures, which reflect an individual&#39;s ability to adapt and be flexible to their ever-changing environment. By using non-invasive heart rate technology, autonomic function can be quantified outside of a traditional controlled research setting.

We demonstrate a 24 h heart rate recording methodology to evaluate the influence of concussion across the recovery trajectory in youth athletes, within an ecologically valid context.

Participation in organized sports makes a significant contribution to youth development, but places youth at a higher risk for sustaining a concussion. To ...

Evaluation of Capnography Sampling Line Compatibility and Accuracy when Used with a Portable Capnography Monitor

Capnography is commonly used to monitor patient&#8217;s ventilatory status. While sidestream capnography has been shown to provide a reliable assessment of end-tidal CO2 (ETCO2), its accuracy is commonly validated using commercial kits composed of a capnography monitor and its matching disposable nasal cannula sampling lines. The purpose of this study was to assess the compatibility and accuracy of cross-paired capnography sampling lines with a single portable bedside capnography monitor. A series of 4 bench tests were performed to evaluate the tensile strength, rise time, ETCO2 accuracy as a function of respiratory rate, and ETCO2 accuracy in the presence of supplemental O2. Each bench test was performed using specialized, validated equipment to allow for a full evaluation of sampling line performance. The 4 bench tests successfully differentiated between sampling lines from different commercial sources and suggested that due to increased rise time and decreased ETCO2 accuracy, not all nasal cannula sampling lines provide reliable clinical data when cross-paired with a commercial capnography monitor. Care should be taken to ensure that any cross-pairing of capnography monitors and disposable sampling lines is fully validated for use across respiratory rates and supplemental O2 flow rates commonly encountered in clinical settings.

The goal of this study was to evaluate the accuracy of capnography sampling lines used in conjunction with a portable bedside capnography monitor. Sampling lines from 7 manufacturers were evaluated for tensile strength, rise time, and ETCO2 accuracy as a function of respiratory rate or supplemental oxygen flow rate.

Capnography is commonly used to monitor patient&#8217;s ventilatory status. While sidestream capnography has been shown to provide a reliable assessment ...

Development and Evaluation of 3D-Printed Cardiovascular Phantoms for Interventional Planning and Training

Catheter-based interventions are standard treatment options for cardiovascular pathologies. Therefore, patient-specific models could help training physicians&#39; wire-skills as well as improving planning of interventional procedures. The aim of this study was to develop a manufacturing process of patient-specific 3D-printed models for cardiovascular interventions.
To create a 3D-printed elastic phantom, different 3D-printing materials were compared to porcine biological tissues (i.e., aortic tissue) in terms of mechanical characteristics. A fitting material was selected based on comparative tensile tests and specific material thicknesses were defined. Anonymized contrast-enhanced CT-datasets were collected retrospectively. Patient-specific volumetric models were extracted from these datasets and subsequently 3D-printed. A pulsatile flow loop was constructed to simulate the intraluminal blood flow during interventions. Models&#39; suitability for clinical imaging was assessed by x-ray imaging, CT, 4D-MRI and (Doppler) ultrasonography. Contrast medium was used to enhance visibility in x-ray-based imaging. Different catheterization techniques were applied to evaluate the 3D-printed phantoms in physicians&#39; training as well as for pre-interventional therapy planning.
Printed models showed a high printing resolution (~30 &#181;m) and mechanical properties of the chosen material were comparable to physiological biomechanics. Physical and digital models showed high anatomical accuracy when compared to the underlying radiological dataset. Printed models were suitable for ultrasonic imaging as well as standard x-rays. Doppler ultrasonography and 4D-MRI displayed flow patterns and landmark characteristics (i.e., turbulence, wall shear stress) matching native data. In a catheter-based laboratory setting, patient-specific phantoms were easy to catheterize. Therapy planning and training of interventional procedures on challenging anatomies (e.g., congenital heart disease (CHD)) was possible.
Flexible patient-specific cardiovascular phantoms were 3D-printed, and the application of common clinical imaging techniques was possible. This new process is ideal as a training tool for catheter-based (electrophysiological) interventions and can be used in patient-specific therapy planning.

Here we present development of a mock circulation setup for multimodal therapy evaluation, pre-interventional planning, and physician-training on cardiovascular anatomies. With the application of patient-specific tomographic scans, this setup is ideal for therapeutic approaches, training, and education in individualized medicine.

Catheter-based interventions are standard treatment options for cardiovascular pathologies. Therefore, patient-specific models could help training ...

Employing the Forced Oscillation Technique for the Assessment of Respiratory Mechanics in Adults

There is increasing interest in the use of the forced oscillation technique (FOT) or oscillometry to characterize respiratory mechanics in healthy and diseased individuals. FOT, a complementary method to traditional pulmonary function testing, utilizes a range of oscillatory frequencies superimposed on tidal breathing to measure the functional relationship between airway pressure and flow. This passive assessment provides an estimate of respiratory system resistance (Rrs) and reactance (Xrs) that reflect airway caliber and energy storage and dissipation, respectively. Despite the recent increase in popularity and updated Technical Standards, clinical adoption has been slow which relates, in part, to the lack of standardization regarding the acquisition and reporting of FOT data. The goal of this article is to address the lack of standardization across laboratories by providing a comprehensive written protocol for FOT and an accompanying video. To illustrate that this protocol can be utilized irrespective of a particular device, three separate FOT devices have been employed in the case examples and video demonstration. This effort is intended to standardize the use and interpretation of FOT, provide practical suggestions, as well as highlight future questions that need to be addressed.

As the use of forced oscillation technique (FOT) is increasingly utilized to characterize respiratory mechanics, there is a need to standardize methods with respect to nascent technical guidelines and various manufacturer's recommendations. A detailed protocol is provided including FOT assessment and interpretation for two cases to facilitate the standardization of methods.

There is increasing interest in the use of the forced oscillation technique (FOT) or oscillometry to characterize respiratory mechanics in healthy and ...