Instructions for Completing the Hbot Parent Designed Report Form

INSTRUCTIONS FOR COMPLETING THE HBOT PARENT DESIGNED REPORT FORM.

Very Important Concept to Understand: This exercise is primarily designed to determine how to continue to treat yourchild in the future and only secondarily as a way to gather data to further science in establishing the best protocols to treat children in general.

With all the hype, cost, and inconvenience associated with doing HBOT, nothing is more important than for you to see whether or not your child is a responder. The only way to know for sure is to document in detail what you saw happen with your child and then have me compare what you saw with what other parents have seen in their children who are of a similar age and who share the same diagnosis. One of the most common comments I hear is, “I didn’t really think I was seeing that much until I completed the form. I was surprised and extremely happy I did it. It helped me more than anything else to see that HBOT was really working for my child after all!” Therefore, because HBOT is a process, not an endpoint, a treatment, not a cure, once we establish that your child is a responder I will then be able to create the best treatment plan to maintain the gains acquired and to achieve even more gains in the future in a way that is best for each child’s specific needs as weighed against each family’s specific set of circumstances.

General Principles:

Allow yourself plenty of time to complete this exercise over several sittings. As documented from the science associated with filling out forms, people complete fewer questions and responses the deeper they go into a questionnaire because they concentrate less and are no longer motivated to apply the same degree of effort.
The more thought that goes into the exercise, the more that placebo effects will be minimized and the truer the picture will be whether or not your child is a responder to HBOT. Remember, we are looking for presence of response, not intensityof response.
Though children are making progress continually, it is the weight of evidence whereby multiplethings begin changing simultaneously within a given period of time that establishes whether a child is a responder or not. This is known as Y-Axis Concept and represents the most important prognostic indicator – rate of change.
To consider each answer alone is valuable. However, when writing the documentation letter it is even more valuable and will save you time if you group things together in a way that makes sense to you, not the way that someone who creates an evaluation tool decides things “should be” grouped, and then write about them all at once.
The changes that occur during the “initiation phase” of HBOT and for the next cycle, and whenever other significant changes are made to an HBOT protocol regarding frequency of treatments, variation in the total number of hours per treatment, variation in the oxygen concentration used, or variation in the pressure used represent the changes most likely to be related to HBOT. It is for these events that I strongly recommend completing the Hyperbaric Oxygen Evaluation Form in its entirety. At all other times when follow-ups are recommended, only a brief summary statement and update is needed.

Specific Instructions:

Complete the Protocol Summary Sheet.
Complete the top portion of the HBOT Parent Designed Report Form (H-PDRF).
Fill in the rows and columns section of the H-PDRF using the intensity scale 0 to 5 whereby 1 represents very little response and 5 represents a significant response. If no benefit is seen, leave the space blank and do not enter a zero. If a response is noted, intensity can always be assigned. However, it is frequently impossible to respond to the question that asks after how many hours of hyperbaric treatment the response first occurred. Please leave this space blank unless you know the answer or are reasonably sure of the time frame.
After completing the rows and columns section, review your answers and create a list indicating your own set of groupingsfor the wayyou categorizesimilar types of responses. One example may include a grouping that includes responses you believe are related to communication. Another grouping may include responses that you believe are related to improved cognitive functions while yet another grouping may include responses you believe indicate your child demonstrated better social skills, etc. When creating your list, first indicate the number of the response followed by a few identifying words so that the concept of each grouping will be easily recognized by you and me without having to go back later to look up the meaning of each number.
Once you have listed everything you believe should be included in a grouping, you are to then document in story form why you believe what you are saying is true. The best way to do this is to describe what your child was like before treatment began, what you have seen occur during the weeks of therapy, and why the changes you observed impressed you enough to say they are most likely due toHBOT. As you write your letter, consider me the judge and jury and yourself the defense attorney whose responsibility it is to present a case that proves beyond a reasonable doubt that what you are presenting is true.

Understanding The Importance Behind This Exercise In Order To Establish Your Child’s Future Treatment Protocols:

Unfortunately a standard scientific study design for HBOThas not yet been able to create an evaluation tool sensitive enough to validate what parents see at home “24/7--365” while at the same time minimizing placebo response.

The standard evaluation tools required for publication in peer review journals are too insensitive to document changes that at occur infrequently, sporadically, and inconsistentlyduring the initial stages of HBOTtherapy. The standard evaluation tools, in association with standardized ways to observe children receiving HBOTtherapy, cannot possibly be expected to validate parental observations that occur infrequently, sporadically, and inconsistently. The use of HBOTis analogous to learning to play an instrument. Initially a student will demonstrate very little accuracy and the teacher will most likely not be present in the room when the student successfully completes a run of notes, a run just as often achieved by accident as by design, and a run definitely not able to be repeated upon demand! Therefore the likelihood of a parent hearing a child speak for the first time who never spoke before and then having the child reproduce this at home at the parent’s request, much less in the examiner’s office, is an unrealistic expectation. The likelihood of an outside observer peering through a window, watching a child play or interact more appropriately than s/he did prior to therapy a few weeks ago is as unlikely as planting a tree seed and getting significant growth within a short period of time. However, though initially such happenings are infrequent, sporadic, and inconsistent, it is these significantly increased number of cumulative new things that parents observe that to them are undeniable and that they can document by detailed examples as to what their child was like before HBOTwas started and how their child has changed within a period of time since starting the treatment that proves their child is an HBOTresponder.

A new evaluation tool needed to be designed that would be more sensitive and specific to capture what HBOTwas responsible for doing in a high percentage of children on the autistic spectrum. The evaluation instrument subsequently created to accomplish this goal was produced by the parents who were observing these cumulative though infrequent, sporadic, and inconsistent happenings “24/7 —365.” The toolis known as the HBOT Parent Designed Report Form. It is the mostspecific tool available if no other concurrent changes are allowed to be introduced or eliminated during an HBOT“initiation phase”. It is the mostsensitive tool available for clinical responses due to HBOTtherapy because parents must document the changes they are observing, indicate the intensity of each response, create their own groupings or categories for the responses seen, and then describe in great detail with as many examples as possible why they believe what they believe to be true.

Sensitivity and specificity are enhanced when parents are required to describe what their child was like before the HBOTclinical trial began as compared to what their child was like at the end of the HBOTinitiation phase. This is known as the Y-Axis Concept. The Y-Axis is the vertical axis used to define the rate of change over baseline from what the child was like before starting HBOTtherapy as compared to what the child was like at the end of the initiation phase. The X-Axis is the horizontal axis and represents the totalamount of change that has occurred in a child relative to the total number improvements and goals parents and teachers want to see relative to some future predetermined point in time by which these goals are expected to be accomplished. The Y-Axis is used to show rate of change for single symptoms as well as to document the rate of change for the cumulative effectiveness of HBOTtherapy for all symptoms being evaluated. Likewise, the X-Axis is used to evaluate the total amount of change for single symptoms plus the total amount of change represented by the cumulative effectiveness of HBOTtherapy for all symptoms being evaluated.

To state X-Axis Concept vs. Y-Axis Concept another way, X-Axis is the distance a child has come within a period of time whereas Y-Axis is the speed in which changes have occurred over baseline during the same period of time. Y-Axis changes represent the most important way to differentiate HBOTresponders from non-responders and Y-Axis changes are by far the most important prognostic indicators available for HBOTtherapy. The X-Axis, how far a child has come per unit time, is what parents and evaluators usually want to see before they are willing to admit that a child is an HBOTresponder. Requiring significant X-Axis changes before classifying a child as an HBOTresponder is serious error and blocks long-term sustained use of a powerful treatment because parents and clinicians have failed to recognize the need for HBOTas demonstrated by Y-Axis Concept. It is imperative to understand that when one compares the starting point from the ending point on the horizontal X-Axis over any period of time, very few children will show more than minimal gains. However, by comparing the slope of the Y-Axis line before HBOTtherapy to after its initiation, the slope of the line undeniably increases for the majority of children and parents report that their child has made many new gains in a short period of time, even though most of these gains were only mild or mild-to-moderate. Bearing this in mind, continuation of therapy is just as important for minor responders as it is for major responders and it may take at least 2 to 3 years or even longer before the cumulative effects of HBOTtherapy will exhibit the maximum results for children so classified from children who were never treated.

NOTE – AFTER READING AND UNDERSTANDING WHAT IS REQUIRED, ALL RED WORDING IS TO BE ERASED!

NEVER ERASE a section heading.

THE FIRST THING TO ERASE IS THIS LINE AND THE ABOVE PARAGRAPHS. Please do not submit to us the General Follow-up form with the above information.

Section A: HBOT Modified And Shortened General Follow-Up Progress Notes Form

NAME:

DATE:

DOB:

AGE IN YEARS AND MONTHS:

WEIGHT:

YOUR CHILD’S PRIMARY DIAGNOSIS(ES):

Is Your Child An HBOT RESPONDER? Yes. No. To be determined. (erase all words and answers that do not apply and)

“This is our xxxxxxxxxxxxx time using soft chamber HBOT.”

If soft chamber was used before indicate:

a)The previous number of treatment sets you have completed was xxxxx (A “set” is defined as any number of dives within a defined period of time. For example, if you did 40 hours within an 8 week period this would be a set of 40.)

b)The previous total number of dives (hours) per each set was xxxxx per set one, xxxxx per set two, xxxxx per set three, etc.

c)The length of each session averaged xxxxx minutes per session.

d)We believe our child did respond to soft chamber HBOT to a mild, moderate, or significant degree (erase all words and answers that do not apply and)

e)If your child responded before, list all the things that were “undeniably” due to the HBOT treatments and not due to “all the other things” that you started at the same time that may have also been helping.

If hard chamber was used before indicate:

b)The previous total number of dives (hours) per each set was xxxxx per set one, xxxxx per set two, xxxxx per set three, etc.

c)The length of each session averaged xxxxx minutes per session.

d)We believe our child did respond to hard chamber HBOT to a mild, moderate, or significant degree (erase all words and answers that do not apply and)

Treatments currently in process and the protocols being used. Indicate the date the treatments began. If you choose to use the form below (preferred), just write after the colon: See form below.

(erase any extra letters and “white space” not needed to clean up the document)

Treatments that have worked in the past or are currently working and to the degree they have helped or are helping (with beginning and ending dates as applicable). If you choose to use the form below (preferred), just write after the colon: See form below.

(erase any extra letters and “white space” not needed to clean up the document)

YOUR QUESTIONS FOR THE DOCTOR TODAY(Be specific. Ask your questions in detail with complete sentences. Do not just use a few words that mean something to you but do not mean anything specific to us. When finished reading thisdefinition, erase it to clean up the document):

10.

(erase any extra numbers and “white space” not needed to clean up the document)

All “Red” In The Entire Document Is To Be Erased Before Submitting For The Clinician To Review.

SECTION B: PROTOCOL SUMMARY SHEET (Please do not submit blank pages. Thank you)
Name: / Beginning date: / Today's date:
The diagnostic protocol requires no fewer than5 treatment days per week with no less than one hour per treatment session. This protocol considers frequency of treatments at least as important as the total number of hours per treatment.
Hard chamber: Pressures: (1.3 ata – rarely used), 1.5, 1.75, 2.0; Oxygen concentration: 100%, (rarely 21%)
Pressure / O2 % / Hood = H, Without = WOH / Number of hours per 1st session on a weekday / Number of hours per 1st session on a weekend / Number of hours between sessions when done on the same day / Number of hours per 2nd session on a weekday / Number of hours per 2nd session on a weekend / Total number of hours completed this week (use this row only) / Cumulative number of hours to date (addition of all weeks)
Week 1
Week 2
Week 3
Week 4
Week 5
Week 6
Week 7
Week 8
Week 9
Week 10
Week 11
Week 12

SECTION C -- Name:Date of this report:

Date HBOT sessions began for this reporting period:

Date HBOT sessions ended for this reporting period:

Number of total HBOT hours of treatment prior to beginning this reporting period:

Number of total HBOT hours of treatment completed by the end of this reporting period:

LOCK IN PLACE your observations at the midpoint, endpoint, and 3 weeks after the last dive. Follow-up only at the midpoint and as close to the 3 weeks post-termination date as possible to review all three data entry points whose data was “locked in”.

Scale 0-5 where 0/left blank = no change; 1 = mild; 2 = mild-to-moderate; 3 = moderate; 4 = moderate-to-significant; 5 = significant

Use for grouping numbers for the "letter" (report) / Intensity of response at the following number of hours or point in time / The response began to be noticed around the following hour of treatment (answer only if known for sure) / 40 to 60 Hour Hard Chamber HBOT PDRF Diagnostic Protocol