a simple modification of the child

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    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 CysticFibrosis 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 (formerlyAmerican Biosystems) child-medium

    vest for oscillatory therapy. We

    changed the configuration of the vest toa "belt" without occluding any of the

    surface features of the vest. The

    Model 103 generator from Advanced

    Respiratory was used. We were able toachieve an effective fit for each of

    these children without significant

    changes in pressure transmitted to the

    chest (.30 psig(vest) versus .38psig(belt)). Pressures for therapy were

    adjusted downward and no childreceived 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 bedelivered. 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 wereincluded 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 madeavailable by special prescription.

    Introduction

    Traditional chest physiotherapy or mechanical percussors have been a mainstay of airway clearancetherapy. Within a group of children

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    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 newbornscreening 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 severemanifestations 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 VESTwith particular attention to:

    1. Clinical indication for the original prescription

    2. Clinical course following the institution of the VEST

    3. Compliance4. Adverse effects

    5. Hospitalizations

    TABLE 1 Clinical indication for the original prescription

    Patient Diagnosis

    Code

    Clinical Indication

    1

    2

    3

    45

    6

    7

    8

    9

    10

    11

    12

    TABLE 2 Clinical courses following the institution of the VEST

    .Patient Diagnosis

    CodeClinical Course

    1

    2

    3

    4

    5

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    6

    7

    8

    9

    10

    1112

    TABLE 3 Compliance

    Patient Clinical

    Setting

    Compliance

    1

    2

    3

    45

    6

    7

    8

    9

    10

    11

    12

    TABLE 4 Adverse Events and Hospitalizations

    Patient Adverse

    Events

    Hospitalizations

    1

    2

    3

    4

    5

    6

    7

    89

    10

    11

    12

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    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) ifthere 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-frequencychest 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 [?], hasgenerated the following observations, questions, and proposed course of study.

    Original HypothesesH0A: 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

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    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 topatients 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 isnecessary or beneficial?

    Sampling Method

    10% of physicians who prescribed 1 vest10% of physicians who prescribed 2 vests

    10% of physicians who prescribed 3 vests

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    10% of physicians who prescribed 4 vests

    10% of physicians who prescribed 5 vests

    10% of physicians who prescribed 6-10 vests10% of physicians who prescribed 11-15 vests

    100% of physicians who prescribed 16 or more vests

    Age

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    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 months5% of patients prescribed vest at 13-24 months

    Under 6 months

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    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 twoprescribing 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

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    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?

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    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 hearabout 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 physiciansare 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?

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    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 ChestCircumferences 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#39425. 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 # YMPD39396. 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 ofinfants 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 transmembraneconductance 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, MarshallBC, Clinical Practice Guidelines for Pulmonary Therapies Committee; Cystic fibrosis

    pulmonary guidelines: Treatment of pulmonary exacerbations.Am. J. Respir. Crit. CareMed. 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. 2009Apr;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 consensusreport.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-basedpractice recommendations for nutrition-related management of children and adults with

    cystic fibrosis and pancreatic insufficiency: Results of a systematic review.J Am DietAssoc. 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.

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    13. Dalkey NC: The Delphi Method: An experimental Study of Group Opinion, research

    Memorandum RM-58888-PR. Santa Monica, Calif, The Rand Corp, 1969.