At ten minutes after noon, Maggie McGuire rushed into the clinic, pulling her Pug, Sydney, behind her. “I’m sorry I’m late, she said breathlessly. “Time just got away from me this morning. Can Tom still do Sydney’s study visit?” The receptionist checked the study coordinator’s schedule and saw that Tom did not have another study visit until later in the afternoon. “Of course. Did you bring your diary? Tom likes to review them before each visit.”
After searching her purse, Maggie remembered that she had thrown the diary in the back seat of her car after Sydney’s last visit. “Darn, I must have left it in the car. We’ll be right back.” Scooping Sydney up under one arm, Maggie ran out the door and back into the clinic’s parking lot.
“What are we going to do, Sydney?” Maggie muttered, as she searched through the pile of debris on her car’s back seat. “I completely forgot about your diary. We’d better fill it out now so we don’t get into trouble with Tom.” Maggie plopped down in the front seat with Sydney in her lap, found a pen in her purse, and began filling out the diary. “Sydney, were you the same, better, or worse this week? I think you got better, especially after I gave you your pill.” Maggie noted Sydney’s “improvement,” as well as an 8am dosing time that seemed close to when she must have given Sydney her pill each morning.
“Here it is,” Maggie sighed as she handed her study diary to the receptionist.
A few minutes later, Tom invited Maggie and Sydney into the exam room. “Wow! It looks like Sydney did very well last week.” Maggie smiled and nodded. “And it’s great that you keep such a regular schedule with the medication. I wish everyone were so diligent.” Maggie winked at Sydney. “See? We were good.”
This charade may be repeated, in one form or another, much more often than any of us would like to admit. Fearful of alienating owners (and, perhaps, losing subjects), study coordinators often hesitate to question diary entries that appear fabricated or inconsistent with previous entries. Is it any wonder, then, that many in the veterinary pharmaceutical industry view owner diaries as useless… or worse? So, if your protocol requires owners to keep a diary, how can you ensure compliance?
The first step is to preview the diary’s design through the eyes of an owner. Are the questions simple, clear, and presented in logical order? Does each question have an explanation, example, or sample answer? Does the comment field provide ample space and directions for what type of additional information should be included? A pre-study test run with several animal owners might highlight areas of potential confusion.
The second step is owner selection. Recruiting animals that meet the protocol’s inclusion/ exclusion criteria is an obvious requirement. However, choosing owners who understand… and, more important, commit to… their study responsibilities can be as critical to a study’s ultimate success as any other single factor. Therefore, a little extra probing during the owner consenting process can tilt the odds toward higher compliance.
The third step is interactive training. For example, after the owner has signed the consent form, the study coordinator and the owner might complete several sample diary entries and discuss possible scenarios requiring special attention. The study coordinator also might give the owner several phone numbers to call should problems arise. And a follow-up call to the owner after one or two days could reinforce the in-office training and correct any shortcomings before the next study visit.
A key part of this training should be a thorough discussion of the test article, its proper storage, and its correct administration. The study coordinator should offer solutions to common problems like a pet that refuses to take the test article, a pet that regurgitates the product, or a pet that vomits the product sometime after taking it. Also included should be ways to keep the test article away from children and other household pets.
The fourth step is reward. A meaningful owner honorarium can entice many owners to be more diligent about their diaries and, thus, enhance the quality of the study data. How much to pay depends on the length and complexity of the study, the number of study visits, and the information that the owner is required to record. When and how to pay the honorarium, also dependent on many of the same factors, usually is the responsibility of the investigator.
Unfortunately, even with these steps, owner compliance continues to be a challenge. However, technology offers the potential for greater success in the near future. For example, software already exists to transmit data that have been recorded electronically, and applications for smartphones and iPads that facilitate owner documentation are under development.
As these systems continue to evolve, owner documentation will become easier and more reliable. Had Maggie been equipped with a smartphone to record Sydney’s progress during the study, would she have been more compliant? Or would she have thrown that in the back seat of her car as well? Only Sydney knows for sure.