Humiston 2011

Methods	Purpose: to compare tracking patient influenza vaccination uptake, providing reminders, patient recall and outreach to patients to standard care in each of 7 clinics Design: RCT, individual seniors were randomised within each clinic to intervention or control Duration of study: 29 September to 13 October 2004 (depending on arrival of influenza vaccine) to 22 January 2004 Interval between intervention and when outcome was measured: 15 weeks Power computation: 170 patients/group to demonstrate 15% difference in vaccination uptake (control rate = 50%) P < 0.05, power 0.80, 2‐tailed; as interest was also to collect data across multiple sites and ethic groups, more patients were enrolled than required by power computation Statistics: Chi2, Fisher's exact, logistic regression; intention‐to‐treat
Participants	Country: USA Setting: 7 clinics in Rochester, NY Eligible participants: (health status): 2004 (control), 1748 (intervention); 50% White, 33% African American, 10% Hispanic, 7% Other Age: avg 74.2 Gender: 62% f
Interventions	Intervention 1: outreach workers in each of 7 clinics tracked patient influenza vaccination uptake, provided reminders, recalled patients, recalled and phoned patients Control: standard routine for each clinic Co‐interventions: none
Outcomes	Outcome measured: % influenza vaccination Time points reported in the study: from 29 September to 13 October 2004 (depending on arrival of influenza vaccine) to 22 January 2004
Notes	Funding; Centers for Disease Control National Immunization Program
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"individual seniors within PCCs to intervention or standard‐of‐care control groups" according to whether last digit of SSN odd or even
Allocation concealment (selection bias)	Unclear risk	No statement
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Blinding not possible due to recalls and prompts
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	3752 eligibles randomised (patients who died during the trial were analyzed as randomised). However: "Each outreach worker was responsible for tracking approximately 900 to 1,000 eligible patients" (which implies for 7 clinics total eligibles = 6300 to 7000)
Selective reporting (reporting bias)	Low risk	No selective reporting