Background The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered. Methods We present data from three single-blind randomised controlled trials—one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)—and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 10 10 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 10 10 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov , NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005). Findings Between April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more t...

We previously developed a mobile- and web-based decision aid (iChoose Kidney) that displays individualized risk estimates of survival and mortality, for the treatment modalities of dialysis versus kidney transplantation. We examined the effect of iChoose Kidney on change in transplant knowledge and access to transplant in a randomized controlled trial among patients presenting for evaluation in three transplant centers. A total of 470 patients were randomized to standard transplantation education (control) or standard education plus iChoose Kidney (intervention). Change in transplant knowledge (primary outcome) among intervention versus control patients was assessed using nine items in pre- and postevaluation surveys. Access to transplant (secondary outcome) was defined as a composite of waitlisting, living donor inquiries, or transplantation. Among 443 patients (n = 226 intervention; n = 216 control), the mean knowledge scores were 5.1 ± 2.1 pre- and 5.8 ± 1.9 postevaluation. Change in knowledge was greater among intervention (1.1 ± 2.0) versus control (0.4 ± 1.8) patients (P < .0001). Access to transplantation was similar among intervention (n = 168; 74.3%) versus control patients (n = 153; 70.5%; P = .37). The iChoose Kidney decision aid improved patient knowledge at evaluation, but did not impact transplant access. Future studies should examine whether combining iChoose Kidney with other interventions can increase transplantation. (Clinicaltrials.gov NCT02235571).

Current medication guides are of little value to patients, as they are too complex and difficult to understand especially for individuals with limited literacy. Explicit guidance is offered for improving these print materials.

Future studies are needed to determine how specific modifications and improvements in drug labeling can enhance patient knowledge and behavior in actual use. Synthesizing best practices across all patient materials will create a more useful, coordinated system of prescription information.

ObjectiveImproved drug labelling for chronic pill-form medications has been shown to promote patient comprehension, adherence and safety. We extended health literacy principles and included patients' perspectives to improve instructions for: (1) non-pill form, (2) short term, (3) ‘as needed,’ (4) tapered and (5) escalating dose medications.SettingParticipants were recruited via convenience sampling from primary care clinics in Chicago, Illinois and San Francisco, California, USA.Participants40 adult, English-speaking participants who reported taking at least one prescription drug in the past 12 months were enrolled in the study.Primary and secondary outcomesParticipant opinions, preferences and comprehension of standard and improved medication instructions were assessed during four iterative waves of discussion groups. Brief interviews preceding the discussion groups measured individuals’ literacy skills, sociodemographic and health characteristics.ResultsOn average, participants were 46 years old, took four medications and reported two chronic health conditions. Patients varied sociodemographically; 40% were men and 33% had limited literacy skills. Patients agreed on the need for simpler terminology and specificity in instructions. Discussions addressed optimal ways of presenting numeric information, indication and duration of use information to promote comprehension and safe medication use. Consensus was reached on how to improve most of the instructions.ConclusionsThrough this patient-centred approach, we developed a set of health literacy-informed instructions for more challenging medications. Findings can inform current drug labelling initiatives and promote safe and appropriate medication use.