David Drozek

Short-Term Effectiveness of a Lifestyle Intervention Program for Reducing Selected Chronic Disease Risk Factors in Individuals Living in Rural Appalachia: A Pilot Cohort Study

Most Western chronic diseases are closely tied to lifestyle behaviors, and many are preventable. Despite the well-distributed knowledge of these detrimental behaviors, effective efforts in disease prevention have been lacking. Many of these chronic diseases are related to obesity and type 2 diabetes, which have doubled in incidence during the last 35 years. The Complete Health Improvement Program (CHIP) is a community-based, comprehensive lifestyle modification approach to health that has shown success in addressing this problem. This pilot study demonstrates the effectiveness of CHIP in an underserved, rural, and vulnerable Appalachian population. Two hundred fourteen participants in CHIP collectively demonstrated significant reductions in body mass index, systolic and diastolic blood pressure, and fasting blood levels of total cholesterol, low-density lipoprotein, and glucose. If these results can be repeated in other at-risk populations, CHIP has the potential to help reduce the burden of preventable and treatable chronic diseases efficiently and cost-effectively.

Preliminary development of the Active Colonoscopy Training Model

Formal colonoscopy training requires a significant amount of time and effort. In particular, it requires actual patients for a realistic learning experience. The quality of colonoscopy training varies, and includes didactic courses and procedures proctored by skilled surgeons. A colonoscopy training model is occasionally used as part of the training method, but the effects are minute due to both the simple and tedious training procedures. To enhance the educational effect of the colonoscopy training model, the Active Colonoscopy Training Model (ACTM) has been developed. ACTM is an interactive colonoscopy training device which can create the environment of a real colonoscopy procedure as closely as possible. It comprises a configurable rubber colon, a human torso, sensors, a display, and the control part. The ACTM provides audio and visual interaction to the trainee by monitoring important factors, such as forces caused by the distal tip and the shaft of the colonoscope and the pressure to open up the lumen and the localization of the distal tip. On the computer screen, the trainee can easily monitor the status of the colonoscopy, which includes the localization of the distal tip, maximum forces, pressure inside the colon, and surgery time. The forces between the rubber colon and the constraints inside the ACTM are measured and the real time display shows the results to the trainee. The pressure sensors will check the pressure at different parts of the colon. The real-time localized distal tip gives the colonoscopy trainee easier and more confident operation without introducing an additional device in the colonoscope. With the current need for colonoscopists and physicians, the ACTM can play an essential role resolving the problems of the current colonoscopy training model, and significantly improve the training quality of the colonoscopy.

Effectiveness of the Complete Health Improvement Program in Reducing Risk Factors for Cardiovascular Disease in an Appalachian Population.

CONTEXT In 11 counties in Appalachian Ohio, the self-reported prevalence of diabetes mellitus (11.3%) is higher than the state (7.8%) or national (7.2%) average. Direct medical costs for diabetes in the United States are estimated at

Employer-Funded Complete Health Improvement Program: Preliminary Results of Biomarker Changes

176 billion annually. Indirect costs from disability, work loss, and premature death add up to another

Abstract 3991: Differentiating esophageal cancer cells from normal cells using ligand-conjugated microspheres

69 billion. OBJECTIVE To determine the effectiveness of the Complete Health Improvement Program (CHIP) in reducing cardiovascular disease (CVD) risk factors in a sample of Appalachian participants with elevated fasting blood glucose (FBG) levels or a diagnosis of type 2 diabetes mellitus (T2DM). METHODS In a retrospective study, data from 6 CHIP cohorts conducted in Appalachian Ohio from 2011 to 2012 were combined and analyzed for short-term changes in CVD risk factors from baseline. This study focused on a subsample of the overall CHIP, whose participants had elevated FBG levels or T2DM. Statistical analysis was completed by calculating means and SDs and using paired t tests to compare differences in variables. RESULTS After the CHIP intervention, 110 participants with baseline elevated FBG levels showed notable reductions in FBG levels, total cholesterol, low-density lipoprotein cholesterol, body mass index, and systolic blood pressure (all P values <.001). Likewise, participants in the subsample with T2DM experienced reductions in all CVD risk factors (all P values <.05). CONCLUSION The CHIP lifestyle intervention was effective in reducing CVD risk factors in this Appalachian population with elevated FBG levels or with T2DM.

Medical Equipment to Make Colonoscopy Procedures Safer for Physicians: Control Head Holder and Splatter Shield

Context Previous studies of the Complete Health Improvement Program (CHIP) have demonstrated short-term improvements in select metabolic and cardiovascular biomarkers in community-based programs. However, less is known about the benefits of an employer-funded lifestyle intervention program. Objectives To determine if participation in employer-provided CHIP would result in improvements in short-term metabolic and cardiovascular biomarkers, and to compare the results of the current study to a larger national study. Methods This observational study evaluated metabolic and cardiovascular biomarker changes in employer health insurance beneficiaries enrolled in CHIP between August 2012 and November 2014. Body mass index; blood pressure (systolic and diastolic); total cholesterol, low-density lipoprotein, high-density lipoprotein, fasting plasma glucose, and triglyceride levels; and weight were measured at baseline and after CHIP. Results Of 160 employees enrolled in CHIP, 115 women and 45 men agreed to participate in the study. Overall, the participants demonstrated significant reductions in body mass index, from a baseline average of 31.5 to a post-CHIP average of 30.5 (P<.001), systolic blood pressure from 124.5 to 119.4 mm Hg (P=.017), diastolic blood pressure from 77.3 to 74.5 mm Hg (P=.046), total cholesterol from 186.0 to 168.8 mg/dL (P<.001), low-density lipoprotein from 112.9 to 99.3 mg/dL (P<.001), high-density lipoprotein from 48.8 to 46.4 mg/dL (P<.001), and fasting plasma glucose from 100.8 to 96.5 mg/dL (P<.001). Conclusion When funded by an employer, CHIP demonstrated short-term improvements in select metabolic and cardiovascular biomarkers. Future studies will analyze these data to determine whether these findings translate into subsequent decreased employee absenteeism and reduced beneficiary health claims.

Development of a colonoscopy add-on device for improvement of the intubation process.

Cancer of the esophagus has a dismal overall prognosis and low 5 year survival rate due to its aggressive nature and the fact that it often presents at a late stage. Biochemical changes present on transforming tissue provide an opportunity for the early detection of cancer within the esophagus and thus the promise of a more favorable prognosis and a higher survival rate. Recently, there has been an increasing effort to detect cancer of the esophagus by introducing, during an endoscopic procedure, soluble molecules (ligands) cognate to moieties preferentially expressed on transforming tissue. The success of this approach depends on the selective binding of the ligand to transforming tissue relative to normal tissue. For soluble ligands, the factors that dictate the selective binding depend on a very small number of factors. In contrast, if the ligands are conjugated to particles, there are a large number of controllable factors that can be manipulated to “engineer” the detection scheme and thus optimize selective recognition of transforming tissue. In this study, we utilized an in vitro system to investigate the feasibility of the ligand-conjugated particle approach. First, we explored the surface chemistry of an esophageal adenocarcinoma cell line, OE19, relative to a normal esophageal cell line, HEEpiC, using flow cytometric analysis. Among other differences, we found that the OE19 cell line expresses relatively high levels of the tetrasaccharides sialyl Lewis A (sLea) and sialyl Lewis X (sLex). sLea and sLex are known cognate molecules for the selectin family of adhesion molecules, in particular E-selectin. Thus, we conjugated an E-selectin construct to 10 μm diameter microspheres. The E-selectin construct consisted of the extracellular domain of E-selectin fused to the Fc domain of IgG. Flow cytometric analysis revealed that the E-selectin construct was conjugated to the microspheres and that the E-selectin portion of the molecule was available for binding. To roughly simulate the introduction of the conjugated microspheres during an endoscopic procedure, a parallel plate flow chamber was used. A planar substrate of either OE19 or HEEpiC cells was placed in the flow chamber and a suspension of E-selectin or IgG (negative control) microspheres were perfused through the flow chamber. We observed that the E-selectin microspheres exhibited significantly greater adhesion to the OE19 cells relative to the HEEpiC cells. In contrast, IgG microspheres exhibited negligible adhesion to the OE19 and HEEpiC cells. Combined, this study provides proof of concept for an assay approach that could be engineered to detect transforming tissue present within the esophagus. Citation Format: Mahboubeh S. Noori, Sarah J. Bodle, Grady E. Carlson, David S. Drozek, Monica M. Burdick, Douglas J. Goetz. Differentiating esophageal cancer cells from normal cells using ligand-conjugated microspheres. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 3991.

Development of an Automatic Adjustable Colonoscope

.............................................................................................................................. 3 Acknowledgments............................................................................................................... 5 List of Tables ...................................................................................................................... 9 List of Figures ................................................................................................................... 10 Chapter 1: Introduction ..................................................................................................... 12 1.1 Literature Review.................................................................................................. 13 1.1.1 Colonoscopy Overview ................................................................................. 13 Chapter 2: Endoscopist Risks Involved in Colonoscopy .................................................. 16 2.1 Forces Involved in Colonoscopy .......................................................................... 17 2.2 Risks Involved in Colonoscopy ............................................................................ 19 2.3 Equipment Which Aid Physicians ........................................................................ 21 2.4 Surface Electromyography and Muscle Fatigue ................................................... 24 2.5 Thesis Objectives .................................................................................................. 25 Chapter 3: Development of the Equipment ...................................................................... 27 3.1 Requirements for the Developed Proof of Concept Prototype ............................. 27 3.2 Development of the Proof of Concept Prototype .................................................. 34 3.3 Failure Mode Effect and Analysis ........................................................................ 46 Chapter 4: Methods of Study. ........................................................................................... 55 4.1 Testing of the CHH ............................................................................................... 55 4.1.1 Test of Fatigue Through Surface Electromyography.................................... 55 4.2 Testing of the Splatter Shield. ............................................................................... 58 4.2.1 Drop Test ...................................................................................................... 58 4.2.2 Drop Ball Test ............................................................................................... 60 4.3 Testing of the TH .................................................................................................. 62 4.3.1 Compliance of a Colonoscope Insertion Tube .............................................. 62 4.3.2 Force Test of the TH ..................................................................................... 66 4.4 Equipment Evaluation Through Survey................................................................ 67 Chapter 5: Results and Discussions. ................................................................................. 70 5.1 Validation of the CHH .......................................................................................... 70 5.1.1 Test for Fatigue Reduction Using Surface Electromyography ..................... 71 5.2 Validation of Splatter Shield ................................................................................. 89 5.2.1 Drop Test ...................................................................................................... 89 5.2.2 Drop Ball Test ............................................................................................... 90 5.3 Validation of the TH ............................................................................................. 91 5.3.1 Force Test of the TH ..................................................................................... 92 5.4 Equipment Evaluation Through Survey................................................................ 94 8 Chapter 6: Conclusions ..................................................................................................... 99 6.1 Evaluation of Thesis Objectives ........................................................................... 99 Chapter 7: Future Work .................................................................................................. 103 Bibliography ................................................................................................................... 106 Appendix A – Bill of Materials of the Developed Equipment ....................................... 110 Appendix B Survey Questions for Equipment Evaluation Survey ............................... 116 Appendix C – Equipment Used for the Research ........................................................... 118 9 LIST OF TABLES Page Table 1 Anthropomorphic data of human hip . ................................................................. 30 Table 2 Anthropomorphic data of factor 31 and 20 . ........................................................ 39 Table 3 The anthropomorphic data of factors 24 and 42. ................................................. 40 Table 4 Failure mode effect and analysis of the CHH. ..................................................... 47 Table 5 Failure mode effects and analysis of the Splatter shield. ..................................... 51 Table 6 Failure mode effect and analysis of the TH. ........................................................ 53 Table 7 Classification of groups for the surface electromyography test. ......................... 72 Table 8 MVC values recorded for biceps brachii at pre and post procedure for with support (WS) and without support (WOS) conditions. ..................................................... 73 Table 9 Sphericity tests for the one way repeated measures ANOVA. ............................ 75 Table 10 MVC values recorded for flexor carpi radialis at pre and post procedure for with support (WS) and without support (WOS) conditions. ..................................................... 79 Table 11 Sphericity tests for the one way repeated measures ANOVA. .......................... 81 Table 12 Percentage RMS EMG activity of biceps brachii recorded at the last minute of the trial to the MVC recorded with support (WS) and without support (WOS). .............. 84 Table 13 Sphericity tests for the one way repeated measures ANOVA for muscle activity of biceps brachii ................................................................................................................ 86 Table 14 Percentage RMS EMG activity of flexor carpi radialis recorded at the last minute of the trial to the MVC recorded with support (WS) and without support (WOS) – flexor carpi radialis. .......................................................................................................... 87 Table 15 Drop test results conducted on the prototype shield .......................................... 90 Table 16 Results of the drop ball test on the shield .......................................................... 91 Table 17 Forces recorded at 3 positions for 3 trials on colonoscope of sizes 12.45mm diameter and 13.7 diameter ............................................................................................... 93 Table 18 Factor of Safety for the force grip imparted by the TH for tube diameters 12.5mm and 13.7mm respectively. ................................................................................... 94 Table 19 Bill of materials of the CHH. ........................................................................... 110 Table 20 Bill of materials of the Splatter Shield............................................................. 112 Table 21 Bill of materials of TH. .................................................................................... 115 10 LIST OF FIGURES Page Figure 1 Colonoscopy clinical support [2]........................................................................ 14 Figure 2 Devices that aid colonoscopy – (Right to left, CW) The neck harness, the colonoscope holder and insertion tube holder [29]–[31]. ................................................. 23 Figure 3 Anthropomorphic data (factor 19) of human hip [39]. ....................................... 30 Figure 4 Modelled CHH in Unigraphics NX and the proof of concept prototype. .......... 35 Figure 5 Modelled shield in Unigraphics NX and proof of concept prototype. ............... 35 Figure 6 Working Model 2D simulation of tipping load of the CHH. ............................. 36 Figure 7 Encircled region indicates the region of gripping by the CHH. ......................... 37 Figure 8 Developed ball joint of the CHH. ....................................................................... 38 Figure 9 Factors 31 and 20 from the Human data digest [39]. ......................................... 39 Figure 10 Factors 21 and 42 taken from the Human data digest [39]............................... 39 Figure 11 Rack and pinion arrangement of the CHH. ...................................................... 40 Figure 12 Developed linear actuator for the Splatter shield. ............................................ 41 Figure 13 Developed lock to hold the shield firmly on the bed........................................ 43 Figure 14 Modelled and fabricated Tube Holder. ............................................................. 44 Figure 15 Pictorial depiction of the drop test. ................................................................... 59 Figure 16 Shield which is fastened together for drop test. ............................................... 60 Figure 17 (a) Drop test apparatus (b) The ball impactor. ................................................. 61 Figure 18 Experimental setup to determine

Lifestyle Medicine: A New Paradigm Embedded in Osteopathic Principles.

A colonoscopy add-on device has been developed to reduce intubation time without modification of the current colonoscope and peripheral devices. One of the main purposes of the system is to minimize trauma caused by the distal tip of the colonoscope. The detachable sensory fixture at the end of the distal tip measures the distance between the distal tip and the colon wall in three directions, and the actuation system attached at the base of the colonoscope controls the distal tip by rotating two dial knobs. The device controls the distal tip to minimize contact between the distal tip and the colon wall, and the distal tip ideally points out the next possible lumen. A compatibility test of the infrared sensory system was carried out, and the design of the actuation system was accomplished. The system is integrated and controlled by a microprocessor. The device was tested in a silicon colon and porcine intestine. The results showed that a colonoscopist successfully reached the cecum with the aid of the colonoscopy add-on device without significant contact between the colon wall and the distal tip. The colonoscopy aid device was very helpful for the novice colonoscopist.

Variable Assessment for Design of Monopolar Hot Biopsy Forceps

Colonoscopy can be associated with many problems, such as mechanical trauma due to the distal tip contacting the colon wall or health issues due to the extended use of anesthesia. In order to eliminate these complications, an automatic adjustable colonoscope was designed. This device uses sensors, actuators, and a control system to automatically position the distal tip in the center of the colon lumen. The sensors were tested to determine their ability to accurately sense the distance from the tip to the surface. The actuators were tested to determine the correlation between motor rotation and displacement of the distal tip. The control system was tested to assess the ability of the device to position the tip in the center of the test tube and the ability to navigate through a flat test course. It was determined that the sensors could accurately determine distances from 0 to 15 mm from the test surface in all test conditions. The motors for up-down movement and left-right movement of the colonoscope had response times of 0.57 s and 0.69 s, respectively, when the motors were rotated from 0 deg to 90 deg. The control system was able to safely move the colonoscope tip away from all walls of the test apparatus. It was also able to navigate through the flat test course without coming in contact with the walls. The automatic adjustable colonoscope has demonstrated that it can safely and effectively position the distal tip to avoid contact with the walls of the test surface.