1.0 Background and Rationale

Back when the earth was cooling and I was a kid, we drank water from the hose and survived. Dirt was proof you played hard. Grass stains built character. Now, based on my literature review of opening my eyes in public, everyone is afraid to get some mud under their fingernails and quality of life is one foot in the junkyard. We are designing this trial to officially prove “a little dirt never hurt anyone.” For this definitive, randomized, placebo-controlled phase III trial, we will enroll 20 kids or until I say we’re done.

2.0 Design

Anything worth doing is worth doing right. Let’s measure twice and cut once. Here’s what I jury-rigged when I was monkeying around in the garage: participant pool comes from scouting the cul-de-sac with half in the dirt arm and half in the placebo arm.

3.0 Objectives

BTW, if I use “we,” just understand I mean me, myself, and I—the only team I can trust. And your mother, supervising.

3.1 Primary Objective

We will test whether dirt hurts anyone. Hypothesis: it doesn’t.

Primary endpoint: dirt and placebo arms will be compared on wuss rate (i.e., hurt rate).

See Appendix A for “hurt” definition.

3.2 Secondary Objective

We will test if dirtier kids are happier. Hypothesis: they are.

Secondary endpoint: dirt and placebo arms will be compared on happier-than-a-dog-with-two-tails rate.

See Appendix B for “happy” definition.

4.0 Inclusion/Exclusion Criteria

Inclusions: Whatever you guys want. I’m easy…with a strong preference for kids who have seen some sun on the old beak.

Exclusions: You’re out if you’ve ever said the phrase “Sunday best.” Or touched a thermostat (on principle).

5.0 Participant Compensation

A couple “attaboys” should do it.

6.0 Randomization

You see this Buffalo nickel? This thing has seen some history. This could have bought me a Ford Mustang back in 1967. Anyway, for each participant we’re gonna flip it: heads for dirt and tails for loser.

7.0 Treatment Plan

Ten subjects will be in the standard of care arm (placebo) and ten will be in the dirt arm (intervention).

Placebo subjects will receive standard of care, which is basically the world fawning over them and constantly reminding them to wash themselves.

Dirt arm subjects will have dirt rubbed into it (“it” means whatever I want it to mean. But in general, unclothed surfaces). Dirt modifications are considered protocol deviations and will not be allowed. Because I said so.

8.0 Statistical Methods

We’ll tally up the proportion of hurt weenies in each group and we’ll give it the old Eye Test. A p-value of less than 0.05 means dirt don’t hurt. P stands for problemo solved. The intent to treat principle will be followed, meaning I intend to treat all participants who don’t get hurt to Five Guys.

9.0 Study Duration

We’ll get there when we get there.

10.0 Criteria for Removal from Study

Basically N/A unless the subject is lost to follow-up.

Where do these darned kids go? He was just here, I swear.

11.0 Funding

Y’all must think I’m made of money. Put it this way: free is my favorite four letter F word. Just kiddin—there are no free lunches. How much is it gonna set me back?

12.0 Ethics Committee

Uncle Mike.

13.0 Appendices

Appendix A

Hurt Adverse Events (HAEs) will be defined by the Dirt Ain’t Discouraged (DAD) scale as follows:

1: solved by the old brushing off (not hurt)

2: solved by manning up (not hurt)

3: solved by being told it is weakness leaving the body (not hurt)

4: solved by walking it off (not hurt)

5: your mother is angry we’ve got a gusher (hurt)

Appendix B

Kid-reported Happiness Survey:

1. There’s pizza in this for you if you cooperate. You happy, kid?

Answer choices:

[  ] Yes

14.0 References

The old noggin was the primary reference. Also, go ahead and toss these trial instructions to the side. Fire up the drill. We’ll figure it out as we go. How hard can it be?