Ram 2015.
Study characteristics | ||
Methods | RCT | |
Participants | 377 household compounds (index cases) completed the study. Control arm has 184 compounds with 1607 contacts, and intervention group has 193 compounds with 1814 contacts. Final analysis was performed on 193 index cases and 1661 contacts in the intervention group and 184 index cases and 1498 contacts in the control group. In 2009, index case‐patients with symptom onset within 7 days preceding enrolment were eligible. Eligibility criteria changed in 2010 to include index case‐patient with symptom onset within 48 hours preceding enrolment. Inclusion criteria:
Exclusion criteria: compounds were excluded if any compound member(s) was reported to have fever within 3 days before index case‐patient enrolment. At another time point, compounds were excluded if any primary household member was reported to have fever (fever occurring within 48 hours prior to enrolment recorded). |
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Interventions | Promoting intensive hand‐washing in households to prevent transmission of ILI. See Table 4 for details. | |
Outcomes | Laboratory: PCR for influenza A and B, with further subtyping of influenza A isolates for all ILI amongst contacts Effectiveness: incidence of ILI. An age‐based definition of ILI was used as follows.
Safety: no safety data planned or reported by investigators |
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Notes | Inclusion/exclusion criteria changed 3 times during the study conduct. The period study conducted: June 2009 to December 2010 Funding: government |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation, with a block size of 4, in order to promote random and even allocation of household compounds to the 2 treatment arms. The list of random assignments was generated by an investigator with no contact with the participants. |
Allocation concealment (selection bias) | Low risk | Once baseline data collection was complete, the data collector notified the field research officer, who consulted the block randomisation list to make the assignment of the household compound to intervention or control. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Relied on symptom reporting from the head of family. Inclusion/exclusion criteria changed 3 times during the study conduct. Given the provision of a hand‐washing station as part of the intervention, it was not possible to ensure blinding of participants, intervention staff, or data collectors. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Relied on symptom reporting from the head of family. Inclusion/exclusion criteria changed 3 times during the conduct of the study. Given the provision of a hand‐washing station as part of the intervention, it was not possible to ensure blinding of participants, intervention staff, or data collectors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Flow chart followed all households an individuals from recruitment to analysis. |
Selective reporting (reporting bias) | Low risk | The specified outcomes are clearly accounted for. Investigators report all outcomes for each modified enrolment. |