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. 2019 Nov 25;2019(11):CD013243. doi: 10.1002/14651858.CD013243.pub2

Thodberg 2016.

Methods 3‐arm RCT
Setting: 4 nursing homes in Denmark. Residents from a broad spectrum of the elderly population, but with a high prevalence of people with dementia at different stages.
Participants 124 nursing home residents
Interventions Following are 3 types of interventions evaluated, all of which consisted of twice‐weekly visits for 6 weeks, totalling 12 visits:
Intervention 1: visits with a dog (either a retriever or a retriever mix) (n = 36)
Intervention 2: visits with a robot seal (n = 41)
Intervention 3: visits with a soft toy cat (n = 34)
Of 124 participants enrolled, 111 were initially randomised, as above.
During the visits, the visitors interacted with the participants making use of the animals to enhance the experience by encouraging interaction between the participants and the animals.
Other than stating that the dog owners (the facilitators) were certified to work as volunteers with dog‐assisted interventions in nursing homes, there was no specific mention on formal training of the facilitators on the use of AAT.
Outcomes Behavioural observation, using a composite sum of the frequencies in "physical contact" and "talk to the visiting animal." However, only the duration of engagement (contact and talking) were reported in numerical figures. The data were in the form of median and interquartile range, hence unsuitable for meta‐analysis and were reported narratively in our results. The other outcome were only reported in terms of P values or in graphical forms, which were not extractable. The authors performed certain measures of affective and cognitive functions, such as the MMSE, Gottfries‐Brane‐Steen scale (which evaluates disabilities, language, psychiatric symptoms, mean daily living function, and behaviour of the participants), and Geriatric Depression Scale, but these were measured only at baseline and not as an outcome measure.
Outcomes assessed 6 weeks after the commencement of the intervention.
Notes Financed by TrygFonden, Denmark, who also mediated the contact to dog owners.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Methods, Design: quote: "The design of the study was a randomized complete block design. Each nursing home was a block, and after informed consent had been given, the participants were assigned randomly to one of three visit types, using a program for blocked randomization in R software (R CoreTeam 2013)."
Allocation concealment (selection bias) Unclear risk Although the statement above suggests that randomisation was probably performed centrally, there was no clear statement to confirm the independence of allocation from randomisation. The authors stated that there were no significant difference among the 3 groups on the baseline psychiatric scores.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Although not clearly stated, blinding was highly unlikely as 1 group received AAT while the other groups received robots or soft toys.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "One person, the visitor, accompanied the animal, and the other person, the observer, made direct observations and a video recording of the visit." The study mentioned that, "The visitors were part of the project staff and were not the owners of the dogs," but there was no further information clarifying the background of the observer, or whether they were from the nursing homes or were project staff.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Of the 124 enrolled participants, the authors stated that 24 dropped out during the experimental period either due to illness or because they did not want to receive the visit. However, we found that 111 participants were randomised initially, suggesting that some of the 24 who dropped out did so before randomisation and some after, with no clarification provided by the authors. In the last analysis, only 98 participants remained. The attrition rate per group from the first to the last analysis was 2 (5.6%) in the AAT group, 7 (17.1%) in the seal group, and 4 (11.8%) in the toy cat group. However, it was unclear how many of the 24 participants who were stated to have dropped out by the author were from each group. We rated this domain as high‐risk due to the overall high dropout rate and the unclear information regarding specific attrition rate from each group.
Selective reporting (reporting bias) High risk Among the outcome data, only the duration of engagement (contact and talking) were reported numerically, although as the data were in the form of medians and interquartile ranges, it was unsuitable for meta‐analysis and was reported narratively in our results. The other outcome were only reported in terms of P value or in graphical forms, which were not extractable.
Other bias Low risk None identified