Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial
Clark R et al. Clinical Infectious Diseases (August 2024)
Bottom line: This phase 3, open-label trial evaluated the co-administration of adjuvanted seasonal quadrivalent influenza vaccine (FLU-aQIV) and respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) in ≥ 65-year-olds. Participants were randomized to receive both vaccines simultaneously (Co-Ad) or sequentially, 1 month apart (Control). Primary objectives were non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration in terms of hemagglutination inhibition (HI) titers for each FLU-aQIV strain, RSV-A and RSV-B neutralization titers, 1 month post-vaccination. The study demonstrated the non-inferiority of vaccine co-administration versus sequential administration in terms of HI titers for the A/Victoria(H1N1), B/Victoria, and B/Yamagata influenza strains and RSV-A neutralization titers (upper limits [ULs] of 95% confidence intervals [CIs] for adjusted geometric mean titer [GMT] ratios [Control/Co-Ad] ≤1.50), but not for A/Darwin(H3N2) HI titers (95% CI UL = 1.53). The immune response to A/Darwin(H3N2) was further assessed post-hoc and showed an adequate response following co-administration. The study also found acceptable reactogenicity and safety profiles for both vaccines when co-administered.
Non-literacy biased, culturally fair cognitive detection tool in primary care patients with cognitive concerns: a randomized controlled trial
Verghese J et al. Nature Medicine (June 2024)
Bottom Line: This randomized controlled trial evaluated the effectiveness of the 5-Cog paradigm, a cognitive detection tool paired with clinical decision support, in improving dementia care actions in primary care patients experiencing health disparities (racial/ethnic minorities and socioeconomically disadvantaged patients). The 5-Cog is a non-literacy biased, culturally-fair, 5-minute cognitive assessment paired with an electronic-medical record (EMR)-embedded clinical decision tree that assists PCPs in making dementia care choices. A total of 1201 older adults (aged 65+) with cognitive concerns and no previous mild cognitive impairment/dementia diagnosis or history of taking dementia medication were enrolled, with 599 assigned to the 5-Cog paradigm and 602 to the control group. The primary outcome was improved dementia care actions, including any of the following endpoints within 90 days: new mild cognitive impairment syndrome or dementia diagnoses as well as investigations, medications or specialist referrals ordered for cognitive indications. The 5-Cog paradigm demonstrated threefold odds of improvement compared to the control group (odds ratio 3.43, 95% confidence interval 2.32–5.07). No serious intervention-related adverse events were reported. This study provides evidence to support the use of the 5-Cog paradigm in promoting practice change and improving dementia care actions in primary care.
Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis : A Randomized Clinical Trial
Zhu L et al. Annals of Internal Medicine (July 2024)
Bottom Line: This randomized clinical trial investigated the effects of acupuncture on degenerative lumbar spinal stenosis (DLSS) in patients with predominantly neurogenic claudication pain symptoms. A total of 196 patients were enrolled and received either 18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow up after treatment. The primary outcome was change in modified Roland-Morris Disability Questionnaire (RMDQ) score at 6 weeks, with a statistically significant difference of -1.3 mean change in score between the acupuncture and sham acupuncture groups (95% CI, –2.6 to –0.03; P = 0.044), indicating a 43.3% greater improvement with acupuncture compared to SA. Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ. The proportion of participants achieving clinically meaningful improvement was higher in the acupuncture group at 16% (95% CI, 1.6% to 30.4%) compared to 12.6% with SA (95% CI, –1.0% to 26.2%) at 6 weeks. Three mild and transient treatment-related adverse events were reported in both groups. Overall, acupuncture may provide pain relief for patients with DLSS, with effects lasting up to 24 weeks after treatment.
