Reporting and communication of randomisation procedures is suboptimal in veterinary trials

Abstract

To evaluate randomisation mechanisms in the veterinary literature, all trials defined as 'randomised' were extracted from five leading veterinary journals for the year 2013. Three blinded investigators evaluated (1) if the random sequence generation was actually non-random, and (2) whether method (CONSORT item 8A) and (3) type of randomisation (CONSORT item 8B) were reported. Trialists were contacted via email to establish (1) willingness to respond to questions on randomisation procedures, (2) whether reporting of randomisation improved following a suggestion to use the CONSORT 2010 guideline. Seven per cent ((95 per cent CI 2 to 12 per cent); 8/114) of the trials defined as 'randomised' explicitly used methods that are considered non-random. Almost half of the trials (49 per cent (40 to 59 per cent); 52/106) did not report any mechanism of randomisation. Only 13 trials (12.3 per cent (6 to 19 per cent); 13/106) reported both items. 39 of 114 (34.2 per cent) trialists contacted were willing to respond to further questions on randomisation mechanisms; 4 (3.5 per cent) trialists were unwilling and 71 (62.3 per cent) trialists did not respond. Email correspondence resulted in a mean clarification of 0.7 items (95 per cent CI 0.4 to 1.0) for the 15 trials for trialists that replied. Improved adherence to CONSORT guidelines and trialists communication is imperative to increase the quality of published evidence in veterinary medicine and to reduce research waste.

Influence of surgical margin completeness on risk of local tumour recurrence in canine cutaneous and subcutaneous soft tissue sarcoma: A systematic review and meta‐analysis

“…The study that found a significantly longer recurrence‐free‐interval for dogs with completely excised STS than those with incomplete or close margins (defined as neoplastic cells within 2 mm of the surgical margin; close margins were re‐categorized to the completely excised group for purposes of this meta‐analysis) reported a mean 669 ± SD of 193 days vs mean 429 ± SD of 285 days, respectively . The final study suggesting complete excision lowered the risk of local recurrence referenced a Kaplan‐Meier survival curve comparing tumours with “complete excision” to “marginal excision” and showed no significant difference (the corresponding author for this study provided additional details that allowed re‐categorization of margin status and clinical outcome data for the present analysis) …”

ARRIVE has not ARRIVEd: Support for the ARRIVE (Animal Research: Reporting of in vivo Experiments) guidelines does not improve the reporting quality of papers in animal welfare, analgesia or anesthesia

“…A recent study of the veterinary literature that focused on reporting of randomization in randomised controlled trials found a higher percentage pf papers (49%, n = 106) reporting the allocation method than reported here (13–20% for SUPP and nonSUPP, respectively) [ 20 ]. This difference is likely to have resulted from selecting papers self-describing as randomised clinical trials.…”

The reporting characteristics of bovine respiratory disease clinical intervention trials published prior to and following publication of the REFLECT statement

“…It is important to acknowledge that systematic allocation approaches are not truly random, and therefore are less likely to achieve the goals of randomization i.e., exchangeability (ignorability) of groups (Greenland and Robins, 2009). While systematic allocation can help to ensure that study units are allocated at the desired ratio to each intervention, it does make knowledge of the allocation sequence more difficult to conceal, which may introduce bias (Di Girolamo et al, 2017;Higgins et al, 2016). For example, if intervention and placebo are given to alternate animals as they pass through a processing chute, an investigator may have an unconscious bias towards putting thinner-looking animals through the chute such that they will receive the preferred intervention.…”