Evaluating the readability of recruitment materials in veterinary clinical research.

BACKGROUND: Owner comprehension is vital to recruitment and study success, but limited information exists regarding the readability of public-facing veterinary clinical trial descriptions. OBJECTIVES: The current study sought to evaluate the readability of public-facing online veterinary clinical trial descriptions from academic institutions and private referral practices. ANIMALS: None. METHODS: This prospective study assessed readability in a convenience sample of veterinary clinical trial study descriptions using 3 common methods: the Flesch-Kincaid Grade Level (F-K), Flesch Reading Ease Score (FRES), and online Automatic Readability Checker (ARC). Results were compared across specialties and between academic and private institutions. RESULTS: Grade level and readability consensus scores (RCSs) were obtained for 61 online clinical trial descriptions at universities (n = 49) and private practices (n = 12). Average grade-level RCS for study descriptions was 14.13 (range, 9-21). Using Microsoft Word, the FRES score was higher in descriptions from universities compared to private practices (P = .03), and F-K scores were lower in university compared to private practice descriptions (P = .03). FRES (P = .07), F-K (P = .12), and readability consensus (P = .17) scores obtained from ARC were not different between institution types. Forty-eight studies (79%) had RCSs over 12, equivalent to reading material at college or graduate school levels. CONCLUSIONS AND CLINICAL IMPORTANCE: Similar to other areas in veterinary communication, the evaluated veterinary clinical trial descriptions used for advertising and recruitment far exceeded the recommended 6th-grade reading level for medical information. Readability assessments are straightforward to conduct, and ensuring health literacy should be a customary best practice in veterinary medicine and clinical research.

Phase I trial of convection-enhanced delivery of IL13RA2 and EPHA2 receptor targeted cytotoxins in dogs with spontaneous intracranial gliomas.

BACKGROUND: The interleukin-13 receptor alpha 2 (IL13RA2) and ephrin type A receptor 2 (EPHA2) are attractive therapeutic targets, being expressed in ~90% of canine and human gliomas, and absent in normal brain. Clinical trials using an earlier generation IL-13 based cytotoxin showed encouraging clinical effects in human glioma, but met with technical barriers associated with the convection-enhanced delivery (CED) method. In this study, IL-13 mutant and ephrin A1 (EFNA1)-based bacterial cytotoxins targeted to IL13RA2 and EPHA2 receptors, respectively, were administered locoregionally by CED to dogs with intracranial gliomas to evaluate their safety and preliminary efficacy. METHODS: In this phase I, 3 + 3 dose escalation trial, cytotoxins were infused by CED in 17 dogs with gliomas expressing IL13RA2 or EPHA2 receptors. CED was performed using a shape-fitting therapeutic planning algorithm, reflux-preventing catheters, and real-time intraoperative MRI monitoring. The primary endpoint was to determine the maximum tolerated dose of the cytotoxic cocktail in dogs with gliomas. RESULTS: Consistent intratumoral delivery of the cytotoxic cocktail was achieved, with a median target coverage of 70% (range, 40-94%). Cytotoxins were well tolerated over a dose range of 0.012-1.278 µg/mL delivered to the target volume (median, 0.099 µg/mL), with no dose limiting toxicities observed. Objective tumor responses, up to 94% tumor volume reduction, were observed in 50% (8/16) of dogs, including at least one dog in each dosing cohort >0.05 µg/mL. CONCLUSIONS: This study provides preclinical data fundamental to the translation of this multireceptor targeted therapeutic approach to the human clinic.

Development and Evaluation of a Caregiver Reported Quality of Life Assessment Instrument in Dogs With Intracranial Disease.

In veterinary medicine, quality of life (QOL) assessment instruments, which are important components of the holistic evaluation of treatment success, have largely not included organ-specific concerns that may be broadly relevant to caregivers of dogs with intracranial disease. The objective of this study was to identify core questionnaire items and domains that contribute to health-related QOL (HRQOL) in dogs with intracranial disease. A questionnaire was developed that contained 39 QOL-related items encompassing physical, social/companionship, and brain-specific domains associated with the treatment of dogs with intracranial disease, and administered to caregivers of 56 dogs diagnosed with genetic, inflammatory, neoplastic, traumatic, and vascular brain diseases, 52 healthy dogs, and 20 dogs with non-neurological illnesses. Clinician derived functional measures of each dog's health status including chronic pain, Karnofsky performance, and modified Glasgow coma scale scores were also recorded. Principal component analysis refined the final questionnaire, termed the CanBrainQOL-24, to 24-items within the three domains with a minimum Cronbach's alpha of 0.7, indicative of good internal consistency. The CanBrainQOL-24 discriminated between healthy and diseased dogs. Physical and brain-specific domains were significantly different between dogs with intracranial and non-neurological diseases. Significant correlations were observed between owner reported visual analog scores and CanBrainQOL-24 scores, as well between clinician derived functional status measures and owner reported QOL. The CanBrainQOL-24 contains core questions relevant to caregiver assessment of HRQOL in dogs with a variety of intracranial diseases, and provides information that is complementary to clinician derived functional outcome measures.

Biomedical and social contributions to sustainability.

Over the past two or three centuries, biomedical advances have provided methods to prevent and treat infectious diseases. These changes have greatly reduced human suffering and enhanced sustainability by allowing people to live longer and healthier lives. The challenge for the coming centuries will be to ensure that these longer, healthier lives are also more productive lives. We must build on the gains of the past by translating new discoveries in regenerative medicine into therapies for degenerative and genetic diseases. Stem cells may be used to identify drugs that prevent the development of symptoms or to replace cells that have either died or lost their physiological function. In the case of genetic diseases, it may be possible to correct the genetic error. While most conditions that might be treated in these ways are common to all communities, some are more prevalent in specific races. Provision of these and other benefits depends not only on attainment of the research objectives, but also upon our ability to make treatment opportunities available throughout both developed and developing communities. The long history of researching and treating infectious diseases shows that it may take many decades to reap the full benefit of the new biological understanding.