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. 2020 Nov 20;2020(11):CD006207. doi: 10.1002/14651858.CD006207.pub5

Temime 2018.

Study characteristics
Methods 2‐arm cluster‐RCT
Participants All residents and staff of 27 privately held chains of nursing homes owned by Korian. 26 nursing homes (13 per arm), with an average of 80 residents per nursing home, were included in the study.
Interventions "The intervention was based on a bundle of HH‐related measures aimed at NH staff, residents, visitors, and outside care providers. These measures included facilitated access to handrub solution using pocket‐sized containers and new dispensers, a campaign to promote HH with posters and event organization, the formation of local work groups in each NH to work on HH guidelines, and staff education using e‐learning on infection control and HH training performed by the same nurse for all NHs."
See Table 4 for details.
Outcomes Laboratory: none used
Effectiveness:
Primary outcomes: incidence rate of ARIs and AGE reported in the context of episodes of clustered cases, defined as at least 5 cases within 4 days amongst nursing home residents or staff. ARIs were defined as the combination of at least 1 respiratory symptom with 1 symptom of systemic infection. AGE was defined as the sudden onset of diarrhoea or vomiting in the absence of a non‐infectious aetiology.
Secondary endpoints were mortality rate, hospitalisation rate, and antibiotic prescription rate (measured in defined daily doses (DDDs) per 100 resident days).
Safety: no adverse event surveillance planned or reported by the investigators
Notes The period study conducted: 1 April 2014 to 1 April 2015
Funding: private (Institute of Ageing Well Korian (Institut du bien vieillir Korian), which runs the nursing homes included in the study)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "simple” randomisation is used
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias)
All outcomes High risk “we suspected that underreporting occurred. The data were verified qualitatively after the end of the intervention through individual phone interviews with each participating NH. Based on these interviews, ARI clustered cases episodes had actually occurred in 12 out of 13 control NHs; however, only 1 had been notified to health authorities. No unreported clustered cases episodes were identified in the intervention NHs”
Blinding of outcome assessment (detection bias)
All outcomes High risk Data were collected at NH level and reported to centralised by the NH group headquarters in Paris through computerised databases. There was underreporting of ARI and AGE in the control groups. The trial authors suspected that underreporting occurred.
Primary outcome: high risk.
Secondary outcomes: low risk
Incomplete outcome data (attrition bias)
All outcomes High risk For the primary outcome, there was underreporting of ARI and AGE in the control groups; no study flow chart was provided; and no reporting on any exclusions. Surveillance is based on voluntary and standardised notifications to health authorities of any AGE or ARI clustered case episode.
Selective reporting (reporting bias) Low risk Reported outcomes match planned outcomes published in the protocol.