In 2001 we presented A Simple Modification of the Child Medium Vest to Facilitate High Frequency Chestwall Oscillation for Children

12-24 Months Old with Chest Circumferences Down to 16 Inches (1) in a Respiratory Therapy Symposium Session at the 2001 North American Cystic Fibrosis Conference. At that time we reviewed a group of 6 patients for whom chest physiotherapy did not achieve effective airway clearance and who where to small to be effectively fit with Advanced Respiratory (formerly American Biosystems) child-medium vest for oscillatory therapy. We changed the configuration of the vest to a "belt" without occluding any of the surface features of the vest. The Model 103 generator from Advanced Respiratory was used. We were able to achieve an effective fit for each of these children without significant changes in pressure transmitted to the chest (.30 psig(vest) versus .38 psig(belt)). Pressures for therapy were adjusted downward and no child received therapy at a pressure setting higher than 4 (range 0 to 10) on the 103 Model Generator. Frequencies for therapy were kept in the range of 10-16 Hz (range 0-25 Hz). Therapy with the "belt" was well tolerated by this group of children and effective therapy could be delivered. There were no adverse events related to this modification. This simple modification may be a helpful adjunct to achieving effective airway clearance therapy in this unique group when chest physiotherapy fails to achieve the desired results. Simple diagrammatic instructions were included as a guideline for changing the vest configuration as well as suggested materials to use. Following this Advanced Respiratory developed a Small Size Child VEST, which was made available by special prescription. Introduction Traditional chest physiotherapy or mechanical percussors have been a mainstay of airway clearance therapy. Within a group of children <24 months old who required daily airway clearance therapy we found a subset for whom these forms of therapy did not achieve adequate mobilization and clearance of secretions. Clinicians at Oakland Children's Hospital, Miller's Children's Hospital of Long Beach Community Medical Center, Ventura County Medical Center and the Pediatric Diagnostic Center of Ventura reported no adverse events with the 'belt' configuration. The new configuration was well tolerated in this group of six children. Parents and caregivers have stated that the children tolerate the therapy better when compared to the 'vest' configuration and feel that there is greater comfort associated with the 'belt'. Until a device to fit these children is available commercially, we have found this simple and inexpensive alteration in configuration to be a safe, well-tolerated alternative to facilitate HFCWO for this special group of children.

At the June 25, 2010 the Genetic Diseases Screening Program California Cystic Fibrosis Centers were challenged by California Childrens Services to justify the often expensive therapies(2,3) now being recommended for infants and toddlers diagnosed with cystic fibrosis through newborn screening prior to pathologic manifestations. The Cystic Fibrosis Foundation has released a number of Consensus Statements for recommended therapies (4-12) in the infant and child. Preliminary Work Over the last decade our facility has continued to utilize the VEST for children over the age of one year, with a history of pneumonia associated with risk for chronic recurrence such as severe manifestations of cystic fibrosis, gastroesophageal reflux disease, brain injury with oral motor dysfunction and aspiration, and inadequate cough due to neuromuscular disease. We performed a retrospective chart review on the 12 patients in whom we prescribed the VEST with particular attention to: 1. Clinical indication for the original prescription 2. Clinical course following the institution of the VEST 3. Compliance 4. Adverse effects 5. Hospitalizations TABLE 1 Clinical indication for the original prescription Patient Diagnosis Code 1 2 3 4 5 6 7 8 9 10 11 12 Clinical Indication

TABLE 2 Clinical courses following the institution of the VEST . Patient Diagnosis Clinical Course Code 1 2 3 4 5

6 7 8 9 10 11 12 TABLE 3 Compliance Patient Clinical Setting 1 2 3 4 5 6 7 8 9 10 11 12 Compliance

TABLE 4 Adverse Events and Hospitalizations Patient Adverse Events 1 2 3 4 5 6 7 8 9 10 11 12 Hospitalizations

Following our own review we felt that data mining the billing records for the VEST would provide a potentially rich source for establishing members of an expert panel (if the number of prescribing physicians was relatively small) or a Delphi process (larger group of physicians by mail or emai) if there proved to be a large geographic distribution. The first author serves on he VEST Scientific Advisory Board and under non-disclosure agreement requested a data set (Table 5) TABLE 5 Data Set
Patient Num Patient State Date of Birth Pgm Entry Date Age at PE Facility Num Facility Name Facility Address 1 Facility Address 2 Facility City Facility State Facility Zip Facility Phone Physician Num Physician Name Physician Address 1 Physician Address 2 Physician City Physician State Physician Zip Physician Phone

The purpose of this study is to examine airway clearance therapy utilizing high-frequency chest wall oscillation in medically fragile children under the age of 2. Currently, little to no research exists on this subject while the number of physicians prescribing vests at an early age has increased steadily over the past 16 years. A preliminary examination of the data supplied by [?], has generated the following observations, questions, and proposed course of study. Original Hypotheses H0A: The vest has not been prescribed to patients under the age of 6 months. H1A: The vest has been prescribed to patients 0 months and up. H0B: Low prescribing doctors are localized around a central hub of a high prescribing doctor. H1B: Low prescribing doctors are not localized around a central hub of a high prescribing doctor. Number of Vests Prescribed Per Physician

High prescribing physicians seem to prescribe the vest later in the patients treatment, usually after 6 months of age; with the exception of Dr. Uriba-Garza, who has prescribed a total of 45 vests to patients as young as 2 months. The majority of physicians have only prescribed one vest. It was initially hypothesized low prescribers would be centralized around hubs of physicians who prescribed many vests. However, this does not appear to be the case. Rather, prescribing physicians seem to be randomly distributed throughout the country. 1. Who prescribes to patients under 6 months? Why? 2. Why have the majority of physicians prescribed only one vest? 3. What can be learned from the high prescribing doctors? Why do they think this early treatment is necessary or beneficial? Sampling Method 10% of physicians who prescribed 1 vest 10% of physicians who prescribed 2 vests 10% of physicians who prescribed 3 vests

10% of physicians who prescribed 4 vests 10% of physicians who prescribed 5 vests 10% of physicians who prescribed 6-10 vests 10% of physicians who prescribed 11-15 vests 100% of physicians who prescribed 16 or more vests

Age

The majority of patients under 2 years old were prescribed the vest after 1 year; a relatively small number were prescribed the vest after 6 months. It was originally hypothesized no patients were being prescribed the vest at 6 months or young; however this is not the case. 4. Why is there a spike in vest prescriptions after 1 year of age? 5. Who are the physicians prescribing the vests at 6 months or younger? Why? 6. Who were among the first to being vest treatment at this age? Why? Sampling Method 100% of patients prescribed vest at 0-6 months 5% of patients prescribed vest at 7-12 months 5% of patients prescribed vest at 13-24 months

Under 6 months

Patients under 6 months who were prescribed the vests are of particular interest. The trends for their diagnoses are similar to the older patients. California and Texas are still the top two prescribing states; however Ohio is no longer in the top. 7. Can anything be correlated to the substantial rise in vest prescriptions in 2007 and later? 8. Why are physicians prescribing vests to patients under 6 months? 9. Do they prescribe vests to this age group more than once? State

California, Texas, and Ohio are the states in which the most vests are prescribed and have been individually broken down. Again, most physicians prescribed only one vest. 10. Are there significant differences in ages of the patients between the states?

11. In what states has developmental screening been implemented? If developmental screening has been implemented, then when? 12. Some prescribing physicians seem to be relatively geographically isolated. How did they hear about treatment with the vest? Why are they using it for patients under 2? 13. What type of marketing is being done for the vest, if any? 14. If marketing efforts are taking place, do the locations coincide with the areas where physicians are prescribing high numbers of vests?

Year

Vest prescription has risen steadily since 1994, which is the earliest recorded year in this data set. 15. Does anything coincide with the significant increase in vest prescription after 2005 and after 2007? Possibly developmental screening (in 2007)? 16. How does the increase in vest prescription spread? Across states? Starting at major cities?

References 1. Landon C , Hall T:A Simple Modification of an Inflatable Vest to Facilitate High Frequency Chest Wall Oscillation for Children 12-24 Months Old With Chest Circumferences of 16-22 Inches Pediatric Pulmonology Supplement 22, 2001.308 2. Lieu TA, Ray GT, et al. The cost of medical care for patients with cystic fibrosis in a health maintenance organization. Pediatrics 1999; 103(6): e72. 3. Krauth C, Jalilvand N, et al. Cystic fibrosis: cost of illness and considerations for the economic evaluation of potential therapies. Pharmacoeconomics 2003; 21(14):1001-24. 4. Marshall BC, Campbell, PW; Improving the care of infants identified through cystic fibrosis newborn screening. J Pediatr. 2009 Dec; 155(6)Suppl:S71-S72. Ref#3942 5. Borowitz D, Robinson KA, Rosenfeld M, Davis SD, Sabadosa KA, Spear SL, Michel SH, Parad RB, White TB, Farrell PM, Marshall BC, Accurso FJ; Cystic Fibrosis Foundation evidence-based guidelines for management of infants with cystic fibrosis. J Pediatr. 2009 Dec; 155(6)Suppl:S73-S93. Ref # YMPD3939 6. Robinson KA, Saldanha IJ, McKoy NA; Management of infants with cystic fibrosis: A summary of the evidence for the Cystic Fibrosis Foundation working group on care of infants with cystic fibrosis. J Pediatr. 2009 Dec; 155(6)Suppl:S94-S105. Ref#3940 7. Borowitz D, Parad RB, Sharp JK, Sabadosa KA, Robinson KA, Rock MJ, Farrell PM, Sontag MK, Rosenfeld M, Davis SD, Marshall BC, Accurso FJ; Cystic Fibrosis Foundation practice guidelines for the management of infants with cystic fibrosis transmembrane conductance regulator-related metabolic syndrome during the first two years of life and beyond. J Pediatr. 2009 Dec; 155(6)Suppl:S106-S116. Ref#YMPD41 8. Flume PA, Mogayzel PJ Jr, Robinson KA, Goss CH, Rosenblatt RL, Kuhn RJ, Marshall BC, Clinical Practice Guidelines for Pulmonary Therapies Committee; Cystic fibrosis pulmonary guidelines: Treatment of pulmonary exacerbations. Am. J. Respir. Crit. Care Med. 2009 Nov;180(9):802-8. Epub 2009 Sept 3. 9. Flume PA, Robinson KA, O'Sullivan BP, Finder JD, Vender RL, Willey-Courand DB, White TB, Marshall BC, Clinical Practice Guidelines for Pulmonary Therapies Committee. Cystic fibrosis pulmonary guidelines: Airway clearance therapies.Respir Care. 2009 Apr;54(4):522-37 10. Farrell PM, Rosenstein BJ, White TB, Accurso FJ, Castellani C, Cutting GR, Durie PR, Legrys VA, Massie J, Parad RB, Rock MJ, Campbell PW 3rd; Guidelines for diagnosis of cystic fibrosis in newborns through older adults: Cystic Fibrosis Foundation consensus report. J Pediatr. 2008 Aug;153(2):S4-S14. 11. Stallings VA, Stark LJ, Robinson KA, Feranchak AP, Quinton H, Clinical practice guidelines on growth and nutrition subcommittee, ad hoc working group; Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: Results of a systematic review. J Am Diet Assoc. 2008;108:832-839. 12. Flume PA, O'Sullivan BP, Robinson KA, Goss CH, Mogayzel, PJ, Willey-Courand DB, Bujan J, Finder J, Lester M, Quittell L, Rosenblatt R, Vender RL, Hazle L, Sabadosa K, and Marshall B; Cystic fibrosis pulmonary guidelines: Chronic medications for maintenance of lung health. Am. J. Respir. Crit. Care Med. 2007; 176: 957-969.

13. Dalkey NC: The Delphi Method: An experimental Study of Group Opinion, research Memorandum RM-58888-PR. Santa Monica, Calif, The Rand Corp, 1969.