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...
Objective:To identify the barriers and facilitators to goal-setting during rehabilitation for stroke and other acquired brain injuries.Data sources:AMED, Proquest, CINAHL and MEDLINE.Review methods:Two reviewers independently screened, extracted data and assessed study quality using the Mixed Methods Appraisal Tool and undertook thematic content analysis for papers examining the barriers and facilitators to goal-setting during stroke/neurological rehabilitation (any design). Last searches were completed in May 2016.Results:Nine qualitative papers were selected, involving 202 participants in total: 88 patients, 89 health care professionals and 25 relatives of participating patients. Main barriers were: Differences in staff and patients perspectives of goal-setting; patient-related barriers; staff-related barriers, and organisational level barriers. Main facilitators were: individually tailored goal-setting processes, strategies to promote communication and understanding, and strategies to avoid disappointment and unrealistic goals. In addition, patients’ and staff’s knowledge, experience, skill, and engagement with goal-setting could be either a barrier (if these aspects were absent) or a facilitator (if they were present).Conclusion:The main barriers and facilitators to goal-setting during stroke rehabilitation have been identified. They suggest that current methods of goal-setting during inpatient/early stage stroke or neurological rehabilitation are not fit for purpose.
Goal setting served a range of different, sometimes conflicting, functions within rehabilitation. Clinicians' identified the integral nature of goals to engage and motivate patients and to provide direction and purpose for rehabilitation. Further, there was an identified need to consider the impact of prioritizing clinician-derived goals at the expense of patient-identified goals. Lastly the reliance on the SMART goal format requires further consideration, both in terms of the proposed benefits and whether they disempower the patient during rehabilitation. Implications for rehabilitation Goal setting is often promoted as a relatively simple, straightforward way to structure interactions with patients Patient-related factors together with resourcing constraints are significant barriers to patient-centered goal setting, particularly during inpatient rehabilitation Clinicians need to have pragmatic tools that can be integrated into practice to ensure that goal-setting practice can be maximized for patients with different intrinsic characteristics.
Objective: To describe goal-setting during in-patient stroke rehabilitation.Design: There were two stages: An electronic questionnaire for multi-disciplinary teams and an analysis of goal-setting documentation for rehabilitation patients. Setting: Five in-patient stroke unitsParticipants: Staff involved in goal-setting and patients undergoing stroke rehabilitation in Results: 13 therapists and 49 patients were recruited. 351 documented goals were examined. All units used therapist-led goal-setting (60% of goals were set by therapists).72% of goals were patient focussed but patients and families had little involvement. Goals focussed on basic mobility and activities of daily living (~50% and ~25% of goals respectively). Only 41% of documented goals met the SMART criteria. Review of progress was limited. 48% of goals were never reviewed and 24% of the remainder were merely marked as ''ongoing' without a date or plan for completion. New goals and actions were How is goal-setting practiced during stroke rehabilitation? 2 often documented without any connection to previous goals. Integration between goals and treatment/action plans was mixed. In two units, goals were unconnected to a treatment or action plan, but for the remainder it was 90-100%. However that connection was generally vague and amounted to suggestions of the type of treatment modality that staff might employ. Conclusions:Goal-setting during in-patient stroke rehabilitation is therapist-led but discussed with the multi-disciplinary team. Therapists mainly identified patient-focussed mobility and activities of daily living goals. Monitoring progress and revising goals were often uncompleted. Links between goals and treatment, action plans and progress were patchy.How is goal-setting practiced during stroke rehabilitation? 3
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