List of items integrated in the MSR and RCR scores for preclinical (n=108) and proof-of-concept (n=461) animal studies on ALS reporting this information
| Reported information | MSR score | ‘Proof-of-Concept’ (n=461) | ‘Preclinical’ (n=108) | |||
| Score item | Score weight | Absolute number | % | Absolute number | % | |
| Relevant animal research variables | ||||||
| Group size | sampsize | 1.5 | 368 | 79.8 | 106 | 98.1 |
| Environment: light, temperature, humidity (fully or partially reported) | climate | 1 | 123 | 26.7 | 42 | 38.9 |
| Cage size | cagesize | 1 | 1 | 0.2 | 2 | 1.9 |
| Mice per cage | nmice | 1 | 26 | 5.6 | 15 | 13.9 |
| Sex of the animals | sex | 1.5 | 223 | 48.4 | 71 | 65.7 |
| Number of transgene copies | copies | 1.5 | 286 | 62.0 | 80 | 74.1 |
| Genetic background | genetic | 1.5 | 349 | 75.7 | 92 | 85.2 |
| Measures to reduce ‘noise’ and bias in experiments | ||||||
| Animals randomised to treatment groups | random | 1 | 28 | 6.1 | 47 | 43.5 |
| Observers blinded to treatment | blinded | 1.5 | 94 | 20.4 | 52 | 48.1 |
| Non-transgenic littermate controls used | control | 1 | 150 | 32.5 | 39 | 36.1 |
| Splitting littermates into groups | sibsplit | 1 | 28 | 6.1 | 31 | 28.7 |
| Reason for exclusion of animals is reported | exclus | 1 | 2 | 0.4 | 6 | 5.6 |
| RCR score | ‘Proof-of-Concept’ (n=461) | ‘Preclinical’ (n=108) | ||||
| Self-reported compliance with laws and regulations | comply | 1 | 98 | 21.3 | 28 | 25.9 |
| Project approval reported | protocol | 1 | 315 | 68.3 | 66 | 61.1 |
| Refinement measures (eg, to aid, feed and hydrate) | refine | 1 | 29 | 6.3 | 14 | 13 |
The score for each variable is provided (MSR score ranging from 0 to 12.5, and RCR score ranging from 0 to 3). Greater weight (1.5 vs 1) was attributed to items which are also part of the ALS guidelines. For purposes of statistical modelling, RCR (only including items comply, protocol and refine) was later simplified to a binary variable RCRb, coded as 1 for RCR values 2–3 and as 0 for RCR values 0–1.
ALS, amyotrophic lateral sclerosis; MSR, Methodological Standards Reporting; RCR, Regulatory Compliance Reporting.