Dataset Information

Quality assurance and best research practices for non-regulated veterinary clinical studies.

ABSTRACT: Veterinary clinical trials generate data that advance the transfer of knowledge from clinical research to clinical practice in human and veterinary settings. The translational success of non-regulated and regulated veterinary clinical studies is dependent upon the reliability and reproducibility of the data generated. Clinician-scientists that conduct veterinary clinical studies would benefit from a commitment to research quality assurance and best practices throughout all non-regulated and regulated research environments. Good Clinical Practice (GCP) guidance documents from the FDA provides principles and procedures designed to safeguard data integrity, reliability and reproducibility. While these documents maybe excessive for clinical studies not intended for regulatory oversight it is important to remember that research builds on research. Thus, the quality and accuracy of all data and inference generated throughout the research enterprise remains vulnerable to the impact of potentially unreliable data generated by the lowest performing contributors. The purpose of this first of a series of statement papers is to outline and reference specific quality control and quality assurance procedures that should, at least in part, be incorporated into all veterinary clinical studies.

SUBMITTER: Davies R

PROVIDER: S-EPMC5559838 | biostudies-other | 2017 Aug

REPOSITORIES: biostudies-other

ACCESS DATA

Similar Datasets

Project description:Till date, with over 137,000 certified members, the most successful rancher educational program has been the Beef Quality Assurance (BQA) program. The BQA program was established in the mid-1990's to improve animal health and welfare with a primary objective to reduce the incidence of injection site lesions by instructing producers to administer injections in the neck only. The present study investigated the drivers of this success to inform future rancher education programs around agricultural sustainability. An online multistate survey was administered to cattle ranchers in collaboration with state cattlemen's associations to better understand rancher motivations for adopting new practices and to gain insight on current involvement in BQA. In total, the survey consisted of 45 questions and was divided into 3 sections: (1) rancher demographics, (2) BQA participation and current best management practice (BMP) application, and (3) willingness to join new rancher educational programs. Data from 842 respondents are including in this study. Of the survey participants, 70% were currently BQA certified or had been BQA certified at one time, and 30% had never been certified. Ranchers who were BQA certified at any time were less likely to administer injections in areas other than the neck compared to ranchers who were not certified (P < 0.05), demonstrating the effectiveness of the BQA program. More than 80% of survey respondents who joined the BQA program stated they believed the BQA program improved animal health and welfare on their operation (n = 617). Among those who had not joined the BQA program, 40% believed BQA practices did not align with their ranching operation, while 38% had not heard of the BQA program (n = 256). The survey indicated that male ranchers, those with more years ranching, those with a larger percent of income coming from ranching, and ranches with larger total acres grazed were more likely to be BQA certified at any time (P < 0.05). Finally, ranchers who were BQA certified at any time were more likely to state that joining a rancher sustainability program would be beneficial to their operation. In conclusion, not only did the survey provide valuable insight into BQA program adoption but highlighted how BQA pedagogy and program structure may be a suitable framework for creating future rancher sustainability programs.

Project description:IntroductionThe quality of tuberculosis laboratory services in health facilities is a mandatory component of detecting active pulmonary TB cases and treatment follow-up. However, ensuring the quality of laboratory test results is a concern. This study aimed to assess the quality assurance practices in the tuberculosis diagnostic health facilities of Ethiopia.Materials and methodsA cross-sectional study was conducted from October 2018 to March 2019 at nine governmental TB-culture laboratories and 34 randomly selected GeneXpert® MTB/RIF (Xpert® MTB/RIF) testing health facilities in Ethiopia. Participating health facilities were interviewed and laboratory documents and records present since 2017 were observed. Prior to the data collection, training was given to the data collectors. Descriptive statistics were used to produce results and were presented with tables and graphs.ResultsFrom a total of 34 Xpert® MTB/RIF testing laboratories, 50% run Internal Quality Control (IQC) for Acid-Fast Bacillus (AFB) Microscopy and 67.6% had lot-to-lot verification of staining reagents. For the Xpert® MTB/RIF assay, a lot-to-lot verification of cartridge and method validation was performed only in 8.8%and 20.6% of Xpert® MTB/RIF testing laboratories respectively. All TB-culture laboratories included in the study ran negative control (start and end IQC) during TB-culture sample processing and performed lot-to-lot verification for Mycobacteria Growth Indicator Tube (MGIT) in 88.9% of TB-culture laboratories. External Quality Assessment (EQA) Proficiency Testing (PT) for AFB microscopy is practiced in 79.4% Xpert® MTB/RIF testing laboratories and 100.0% for the Xpert® MTB/RIF assay. TB-Culture PT participation practice among TB-culture laboratories was 88.9%. A major challenge for health facilities during PT participation was the AFB PT-sample transportation delay (40.7%) and the Xpert® MTB/RIF assay EQA-PT feedback missing (38.2%).ConclusionThis assessment reveals that IQC for AFB microscopy, lot-to-lot verification, method validation, and equipment calibration were not well-practiced. The majority of TB diagnostic health facility laboratories had EQA-PT participation practice, but a significant gap in PT-sample transportation and missing feedback was identified.

Dataset Information

Quality assurance and best research practices for non-regulated veterinary clinical studies.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets