PetSORT Checklist

Check out the  PetSORT Explanation and Elaboration publication here.

PetSORT checklist of information to include when reporting a randomized trial.

Section/topic Item No. Checklist item Page No.
Title and Abstract
  1a Identify the study as a randomized trial in the title.  
  1b Summarize the objective, trial design, primary outcome(s), study population, intervention, results, and conclusions/clinical relevance.  
Introduction
Background 2a Give scientific background and explanation of rationale.  
Objectives 2b Specify objectives or hypotheses.  
Methods
Trial design 3a Describe trial design (such as parallel, factorial, crossover) and the level of allocation of the intervention (such as animal, litter, kennel). For crossover trials, description of the number and duration of intervention and washout periods.  
Trial design 3b Report any changes to methods after trial commencement (such as eligibility criteria), with reasons.  
Participants 4a Report eligibility criteria for animals and their caregivers (includes owners of pets and custodians of shelter animals) at all organizational levels (such as animals or veterinary clinics). State whether animals were shelter-owned or client-owned.  
Participants 4b Describe settings and locations where the data were collected. Describe sources of clustering (such as multiple veterinary practices or group housing).  
Interventions 5 Describe interventions for each group with sufficient details to allow replication. Describe the unit of allocation (such as body part (eye), individual animal, litter).  
Outcomes 6a Completely define pre-specified primary and secondary outcome measures, including how, when, and by whom they were assessed.  
Outcomes 6b Describe any changes to trial outcomes after the trial commenced, with reasons.  
Outcomes 6c If the outcome of interest (such as survival time) could be differentially impacted by euthanasia, describe methods used to reduce bias in study results (such as standardized criteria or counseling for euthanasia).  
Sample Size 7a Provide a sample size calculation or a justification for the sample size if a calculation was not performed.  
Sample Size 7b When applicable, explain any interim analyses and stopping guidelines.  
Randomization
Sequence generation 8a Describe the method used to generate the random allocation sequence.  
Sequence generation 8b Describe the type of randomization and include details of any restriction (such as stratification, blocking, and block size) used.  
Allocation concealment 9 Describe the steps taken to conceal the allocation sequence until interventions were assigned.  
Implementation 10 Describe who generated the random allocation sequence, who enrolled study subjects, and who assigned them to interventions.  
Blinding or masking 11a Report which individuals (such as caregivers, investigators, outcome assessors, data analysts) were blinded/masked after allocation. Provide justification if not blinded/masked.  
Blinding or masking 11b  If relevant, describe the similarity of interventions.  
Statistical methods 12a Describe the statistical methods used to compare groups for primary and secondary outcomes.  
Statistical methods 12b Describe the methods used for ancillary analyses, such as subgroup analyses and adjusted analyses; report if these were pre-specified in the protocol or unplanned.  
Results
Study subject flow 13a For each group, state the number of study units (body part, individual animal, or litter) that were assessed for eligibility, randomly assigned, received the intended intervention, and were analyzed for each primary and secondary outcome.  
Study subject flow 13b Quantify and explain any losses and exclusions after randomization for each group (such as the number per group removed due to adverse events) and for each intervention period in a crossover trial.  
Recruitment 14a Report the dates defining the periods of recruitment and follow-up.  
Recruitment 14b If the trial was discontinued early, provide the reason.  
Baseline data 15 Provide a detailed description (such as a table) of baseline demographic and clinical characteristics that could impact the outcomes for each intervention group.  
Numbers analyzed 16 Report the number analyzed for the primary and all secondary outcomes and whether the analysis was by original assigned groups (intervention-to-treat) or per-protocol. Explicitly report the numbers of units lost to follow-up and, if relevant, the number of animals with changed intervention assignments (if relevant for per-protocol).  
Outcomes and estimation 17a For each primary and secondary outcome, report the results for each group, and the estimated effect size and its precision (such as 95% confidence interval).  
Outcomes and estimation 17b For binary outcomes, present both absolute and relative effect sizes.  
Ancillary analyses 18 Present the results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from unplanned or exploratory analyses.  
Harms 19 Describe the methods for detection of adverse events and report all adverse events (expected, unexpected, and suspected) or unintended effects observed in each group or their absence.  
Discussion
Interpretation 20 Ensure that interpretation is consistent with results, balancing benefits and harms, and considering other relevant evidence.  
Generalizability 21 Discuss generalizability (external validity, applicability) of the trial findings.  
Limitations 22 Discuss trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses. Consider potential carryover effects of a crossover trial.  
Other information  
Registration 23 State whether the trial was registered and, if so, provide a registration number and name of the trial registry. If not, provide a reason for not registering the trial in advance.  
Protocol 24  State if the full trial protocol was finalized a priori and where it can be accessed. Describe any protocol deviations with justification.  
Funding and transparency 25 State sources of funding and other support (such as supply of drugs), role of funders, conflict of interest, ethical approval for human (if applicable) and animal subject use, and quality standards used.