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. 2023 Jan 30;2023(1):CD006207. doi: 10.1002/14651858.CD006207.pub6

Savolainen‐Kopra 2012.

Study characteristics
Methods Open cluster‐RCT, 3‐arm intervention trial
Participants A total of 21 clusters (683 individuals) were randomised to implement hand hygiene with soap and water (257 individuals), alcohol‐based hand rub (202 individuals), or control (224 individuals).
The study was conducted in distinct office work units in 6 corporations in the Helsinki Region that together employed some 10,000 staff. All employees (age ≥ 18 years, both genders) were contacted by email survey.
Inclusion criteria: quote: "Volunteers working in defined units"
Exclusion criteria: quote:"Persons with open wounds or chronic eczema in hands"
The designated 21 study clusters were identified as operationally distinct working units, each containing at least 50 people.
Interventions Hand hygiene with soap and water and standardised instructions on how to limit the transmission of infections. Usual hand hygiene (control). See Table 4 for details.
Outcomes Laboratory:
Quote: "Between November 2008 and May 2010, the seven occupational health clinics serving the six participating corporations were advised to collect, using standard techniques, two to three respiratory samples per week from typical RTI patients and also faecal samples from a few representative patients with gastrointestinal symptoms when a GIT outbreak was suspected. The samples could originate from the study participants and also from work units not included in the study. In the laboratory, viral nucleic acids were extracted with well‐characterized commercial kits and tested by validated real‐time PCR methods to detect influenza A and B viruses, respiratory syncytial virus, parainfluenza virus types 1, 2, and 3, adenoviruses, human rhinoviruses and human enteroviruses from respiratory specimens, and norovirus from faecal specimens (detailed descriptions of the test procedures are available from the authors)."
Effectiveness:
Predefined primary endpoints:  
  1. Number of reported infection episodes in a cluster per total reported weeks.

  2. Number of reported sick leave episodes in a cluster per total reported weeks.


Secondary endpoints and outcome measures:
  1. Number of days with reported symptoms of RTI and/or GTI in a cluster within a time frame of 100 reporting weeks.

  2. Number of days‐off due to own RTI or GTI in a cluster within a time frame of 100 reporting weeks.


Safety: reported 0 adverse events 
Notes The period study conducted: January 2009 to May 2010
Government funded.
Competing interests: the authors declare that they have no competing interests.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information
Allocation concealment (selection bias) Low risk Quote:"clusters were matched and randomized prior to onset of the interventions"
Blinding of participants and personnel (performance bias)
All outcomes High risk The interventions were not blinded to any party involved (i.e. the study group, participants, or the occupational health services). Subjective reporting of disease episodes
Blinding of outcome assessment (detection bias)
All outcomes High risk Subjective reporting of disease episodes
Incomplete outcome data (attrition bias)
All outcomes High risk 24% loss to follow‐up. However, new recruiting in most clusters; the total number of reporting participants at the end of the trial was 91.7% compared to that at the beginning. Attrition was reported, and 76% of volunteers who started reporting continued to do so until the end of the study. Because of new recruiting in most clusters, the total number of reporting participants at the end of the trial was 626, or 91.7%, compared to that at the beginning. This means that 15.7% of the participants were replaced during the study!!! Raw data on the effects of the interventions on the occurrence of respiratory infections and vomiting/diarrhoea diseases were not reported. Zero adverse effects were reported.
Selective reporting (reporting bias) Low risk All planned outcomes were reported.