Use of the Animal Welfare Assessment Grid to assess the life time experience of animals and cumulative severity of procedures

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Use of the Animal Welfare Assessment Grid to assess the life time experience of animals and cumulative severity of procedures Sarah Wolfensohn OBE BSc MA VetMB CertLAS FSB DipECLAM DipECAWBM-WSEL MRCVS European Recognised Specialist in Laboratory Animal Science Professor of Animal Welfare University of Surrey School of Veterinary Medicine

Cumulative what? Welfare? Severity? Suffering? Does it matter to the animal what you call it? Perceptions..it matters to people what you call it EU Directive 2010/63: Severity category shall take into account: Nature of p,s,d&lh and its intensity, the duration, frequency and multiplicity of techniques and cumulative suffering within a procedure Russell & Burch: direct and contingent suffering

What is cumulative suffering = Direct suffering (procedural detail on the licence), clinical conditions + Contingent suffering (housing, husbandry, transport) X Duration

Life time experience + + +

Disease and injury

Cumulative suffering: lab animal, pet animal, farm animal or wild animal* Animal s perception of welfare, not affected by its reason for life or the cause of its suffering Is it acceptable for animals to suffer in the name of scientific progress? If so, how much and for how long? Function of the ethical review process and the Regulatory Bodies Success of this depends on the prevailing institutional culture and regulatory authority Need consistency between institutions and member states *Wolfensohn & Honess 2007 Animal Welfare 16 supplement 1, 117-123

Cumulative suffering Function of ethical review: Needed for harm:benefit judgement Prospective, on-going and retrospective How can you estimate it? Who should estimate it? When should you estimate it? Need an objective measurement Can cumulative suffering be justified?

Ethical review balances benefit vs harms Justification 3Rs Replacement Reduction Refinement HOW we do animal research affects the level of cumulative suffering

Is this enrichment?

Severity classification Severity intensity Duration of each component? Is it getting better or worse? What is the overall quality of life? 30 SEVERITY LIMIT : MODERATE 25 20 15 10 5 0 Training MRI Surgery 1 Fight trauma Surgery 2

CUMULATIVE WELFARE SCORE Illustration of cumulative severity SEVERITY CLASSIFICATION? 99 77 60 35 20 Event 1 Training Event 2 MRI scanning Event 3 Surgery Event 4 Fight injury Event 5 Second surgery MODERATE SEVERITY LIMIT TIME

Assessing cumulative suffering Animal Welfare Assessment Grid (AWAG) ATLA (2010) 38 205-212

Basic welfare assessment grid Experimental /clinical events reflecting direct suffering and due to concurrent illness Score 1 - Mild 10 - Severe Procedural Events Physical 10 8 6 4 2 Clinical condition: reflecting physical wellbeing Score 1 - Normal 10 Grossly abnormal Psychological 10 8 6 4 2 Quality of the environment reflecting contingent suffering due to husbandry Score 1 - enriched 10 - barren 2 4 6 8 10 2 4 6 8 10 Environment Behavioural deviations reflecting psychological wellbeing Score 1 - Normal 10 Grossly abnormal

Welfare: The five domains Nutrition Environment Health Behaviour Mental state AWAG Parameters: Physical Psychological Environment Procedural Duration? Single moments in time?

Validation: retrospective use of the AWAG using data on TB vaccine studies* Four studies, retrospective data Different vaccine regime Different challenge Different housing Different species Different end points Effect on quality of life? Quantitative assessment of cumulative suffering *Wolfensohn S, Sharpe S, Hall I, Lawrence S, Kitchen S & Dennis M (2015). Animal Welfare 24 139-149

Vaccine efficacy studies against primary infection in macaque challenge model Rhesus and cynomolgus species used 3 efficacy studies performed in the macaque TB aerosol challenge model 1 efficacy assessment performed in the BCG challenge model All included BCG ID vaccinated and not vaccinated groups Housing: Study Species Vaccine Challenge 1 Rhesus BCG ID in BSL 2 Mtb 50 CFU BSL3 52 weeks 2 Cynomolgus BCG ID in BSL 2 Mtb 75 CFU BSL3 26 weeks 3 Rhesus BCG ID in breeding unit Mtb 75 CFU BSL3 16 weeks 4 Rhesus BCG ID in BSL 2 BCG BSL2 2 weeks Study designs BCG Mtb End: Necropsy Study 1. 2 3 BCG End: skin biopsy 4 Week 0 21 23 37 47 73

PHYSICAL: scoring factors 1. General condition (weight-loss, condition score etc) 1 2 3 4 5 6 7 8 9 10 Weight loss of zero up to 1.9% score 2, from 2-3.9% score 3, from 4-5.9 % score 4, from 6-9.9% score 5,from 10-14.9% score 6, from 15-19.9% score 7, from 20-24.9% score 8, over 25% score 10 2. Clinical assessment 1 2 3 4 5 6 7 8 9 10 eg cough, diarrhoea, ascites, tachypnoea, dyspnoea, vomiting, temperature 3. Activity level, mobility 1 2 3 4 5 6 7 8 9 10 4. Presence of injury 1 2 3 4 5 6 7 8 9 10 5. Not eating/drinking 1 2 3 4 5 6 7 8 9 10 Food/water intake less than 40% for 3 days score 6, food/water intake below 40% for 7 days or anorexic for 3 days score 9.

Behavioural/Psychological: Scoring factors 1. Stereotypy, self-harming, unusual grooming 1 2 3 4 5 6 7 8 9 10 Take into account the frequency and time spent in the abnormal behaviour, not just the extent of physical damage to the animal 2. Response to catching event 1 2 3 4 5 6 7 8 9 10 What method is used? How long does it take? 3. Hierarchy upset/dispute, aggression/bullying 1 2 3 4 5 6 7 8 9 10 Take into account extent and duration 4. Use of enrichment 1 2 3 4 5 6 7 8 9 10 5. Aversion to normal events 1 2 3 4 5 6 7 8 9 10 Such as staff interaction, cage cleaning etc. Is the animal well trained and habituated or stressed and frightened or aggressive?

Environmental: Scoring Factors 1. Housing 1 2 3 4 5 6 7 8 9 10 Free range type environment score 1. Consider the space provision, lighting, ventilation, weather exposure, animal friendly materials, noise. Adjust to take account of the species and size of the animals. 2. Group size 1 2 3 4 5 6 7 8 9 10 Singles score 10, pairs score 6, small groups (3 to 5) score 4, medium size groups (6 to 8) score 3, breeding groups score 1. 3. Provision of 3D enrichment 1 2 3 4 5 6 7 8 9 10 Consider the ability to climb, jump, hide, establish and maintain social hierarchy without aggression and fighting. 4. Provision of manipulable enrichment 1 2 3 4 5 6 7 8 9 10 Consider forage material, food provision and the variety of what is offered. 5. Contingent events 1 2 3 4 5 6 7 8 9 10 Consider if the animal has been moved, on-going building works etc.

Procedural (experimental/clinical): Scoring Factors 1. Restraint 1 2 3 4 5 6 7 8 9 10 Is positive reinforcement training used or is the animal aggressive and frightened? What method is used? 2. Sedation 1 2 3 4 5 6 7 8 9 10 Consider duration, quality of induction and recovery, effect on food intake and behaviour. 3. Effect of intervention 1 2 3 4 5 6 7 8 9 10 To what extent has it impacted on the animal s welfare? What has been the overall effect on the animal s welfare of the procedure carried out, even if done for the animal s benefit in the longer term. 4. Change in daily routine 1 2 3 4 5 6 7 8 9 10 Consider such things as withholding enrichment or food, restricting access to usual living area.

Calculation of cumulative effects on welfare The scores for each factor were entered into a spread sheet that automatically calculated the average score for each of the four parameters, produced an AWAG at each time point, calculated its area and plotted that area across the animal s life time

AWAG to illustrate temporal component

60.0 CWAS: Life time experience, individual animals - S36 Study 3 unvaccinated 50.0 40.0 30.0 20.0 10.0 0.0 0 200 400 600 800 1000 1200 801 1084

Procedural S36 Day 801 10.0 9.0 8.0 7.0 6.0 5.0 4.0 3.0 2.0 1.0 0.0 Physical Psychological WAG: S36 day 801 Environmental Animal S36: Study 3 unvaccinated Procedural S36 Day 1084 10 Physical 9 8 7 6 5 4 3 2 1 0 Psychological Environmental WAG: S36 day 1084

Use of the AWAG to compare studies and demonstrate effect of refinement Survival study vs fixed end point study, duration of end point Housing whole study in CL3 vs pre-challenge in breeding facility building Species difference and import vs home bred Different challenge dose M.Tb Different study design (M.Tb vs BCG challenge) Degree of severity across whole study Vaccinated and unvaccinated groups in each study

animal K80 week 48 10.0 9.0 Physical 8.0 7.0 6.0 5.0 4.0 3.0 2.0 Procedural 1.0 0.0 Psychological Environmental Animal K80 week 61 10.0 Physical 9.0 8.0 7.0 6.0 5.0 4.0 3.0 2.0 1.0 Procedural 0.0 Psychological Environmental

Refinement of environment

See Honess & Wolfensohn 2010 ATLA 38 205-212

The outcome of using the welfare assessment grid Allows objective feedback on changes affecting animal welfare and objective evaluation of the animal s quality of life and cumulative suffering Enables drilling down to the separate components of welfare: Physical, Psychological, Environmental, Procedural Visual representation of welfare which may be easily understood and allows communication about animal welfare between care staff, research staff, ethical review committee members, regulators, funders and the public

Why is welfare measured? If welfare is identified as sub-optimal find the cause identify a solution The outcome of measurement should be action to improve welfare Do nothing justify why not experimental constraints? On going refinements can be targeted at specific elements Then keep monitoring to demonstrate Improvements in welfare

The Animal Welfare Assessment Grid: AWAG software free to download from https://github.com/publichealth England/animal-welfareassessment-grid

(Lloyd, Foden & Wolfensohn 2008 Laboratory Animals 42 284-293) The refinement loop Critical evaluation of well-being and science Implementation, evaluation and dissemination of good practice Recognition of pain and poor welfare Selection of improvement strategies Diagnosis of problem

Wider applications Use of the system in other veterinary sectors to evaluate life time experience Marwell Zoo Animal rescue centres To facilitate decision making and improve welfare

Acknowledgements Thanks to Public Health England for providing funding to support this project, particularly: Mike Dennis Sally Sharpe Ian Hall Tomasz Zatorski Phil Luton Pete Storey