Luby 2005.

Study characteristics
Methods	Partly double‐blind, cluster‐RCT carried out during 15 April 2002 to 5 April 2003 in Karachi, Pakistan. The trial assessed the effects of mother and child hand‐washing on the incidence of respiratory infections, impetigo (data not extracted), and diarrhoea (data not extracted). Randomisation took place by computer‐generated random numbers in 3 phases. 25 neighbourhoods were assigned to hand‐washing and 11 to standard practice. 300 households were assigned to using antiseptic soap. 300 households were assigned to using plain soap. 306 households were assigned to standard practice. 1523 children younger than 15 years were assigned to using antiseptic soap. 1640 children younger than 15 years were assigned to using plain soap. 1528 children younger than 15 years were assigned to standard practice. Soaps were of identical weight, colour, and smell and were packed centrally with a coded packing case matched to households containing 96 bars. Neither field workers nor participants were aware of the content. Control arm households were visited with the same frequency as intervention household but were given books and pens. Codes were held centrally by the manufacturer and broken after the end of the trial to allow analysis.
Participants	Householders of slums in Karachi. Of the 1523 children younger then 15 years assigned to using antiseptic soap, 117 dropped out (1 died, 51 were born in, and 65 aged out) = 1406; 504 were aged less than 5. Of 1640 children younger then 15 years assigned to using plain soap, 117 dropped out (3 died, 44 were born in, and 70 aged out) = 1523; 517 were aged less than 5. Of 1528 children younger then 15 years assigned to standard practice, 125 dropped out (3 died, 40 were born in, and 82 aged out) = 1403; 489 were aged less than 5.
Interventions	Instruction programme and antibacterial soap containing 1.2% triclocarban, or ordinary soap to be used throughout the day by householders, or standard procedure. See Table 4 for details.
Outcomes	Laboratory: N/A Effectiveness: Number of new respiratory illness per person per week Pneumonia (cough or difficulty in breathing with a respiratory rate of > 60 min in children less than 60 days old, > 50 min in those less than 1 year old, and > 40 min for those aged 1 to 5 years) Follow‐up was weekly with household interview and direct observation. Children aged less than 5 were weighed, and the report presents stratification of results by child weight. Safety: N/A
Notes	Risk of bias: low (cluster coefficients and analysis by unit of randomisation provided) Note: the authors conclude that "handwashing" neighbourhoods has significantly fewer episodes of respiratory disease than controls (e.g. 50% less cough). "Handwashing" children aged less than 5 had 50% fewer episodes of pneumonia than controls (−65% to −35%). However, there was no difference in respiratory illness between types of soap. The report is confusing, with a shifting focus between children age groups. The impression reading is of an often rewritten manuscript. There is some loss of data (e.g. in the results by weight, i.e. risk group) because of lack of clarity on denominators. Despite this, the trial is a landmark. Funding: most of the funding for this study was provided by Procter and Gamble, manufacturer of Safeguard Bar Soap. The balance of the funding was provided by the Centers for Disease Control and Prevention. Conflict of interest statement: S Luby was supported by the grant from the Procter & Gamble company that funded this study. W Billhimer is an employee of the Procter & Gamble company. The other authors declare that they have no conflict of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation took place by computer‐generated random numbers in 3 phases.
Allocation concealment (selection bias)	Low risk	Quote:"One of the investigators (SL) who did not participate in recruiting neighbourhoods or households programmed a spreadsheet to randomly generate the integers of a 1 or a 2. He applied the random numbers sequentially to the list of neighbourhoods. Neighbourhoods with a 1 were assigned to control, and those with a 2 were assigned to handwashing promotion. Random assignment continued until neighbourhoods consisted of at least 600 handwashing promotion households and 300 control households were assigned."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote:"The antibacterial soap ... contained 1‐2% triclocarban as an antibacterial substance. The plain soap was identical to the antibacterial soap except that it did not contain  triclocarban... . Neither the fieldworkers nor the families knew whether soaps were antibacterial or plain."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote:"Neither the fieldworkers nor the families knew whether soaps were antibacterial or plain."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	89% of the study population followed up, but no data on the clusters.
Selective reporting (reporting bias)	Low risk	Quote:"At baseline, households in the three intervention groups were similar."