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Izurieta, H. S., Wu, X., Forshee, R., Lu, Y., Sung, H. M., Agger, P. E., Chillarige, Y., Link-Gelles, R., Lufkin, B., Wernecke, M., MaCurdy, T. E., Kelman, J., Dooling, K.
Background
Shingrix (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as 2 doses given 2–6 months apart among adults aged ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster, but post-market performance has not been evaluated. Efficacy of a single dose and a delayed second dose and efficacy among persons with autoimmune or immunosuppressive conditions have not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix.
Methods
We conducted a cohort study among Medicare Part D community-dwelling beneficiaries aged >65 years. Herpes zoster was identified using a medical office visit diagnosis with treatment, and postherpetic neuralgia was identified using a validated algorithm. We used inverse probability of treatment weighting to improve cohort balance and marginal structural models to estimate hazard ratios.
Results
We found a vaccine effectiveness of 70.1% (95% confidence interval [CI], 68.6–71.5) and 56.9% (95% CI, 55.0–58.8) for 2 and 1 doses, respectively. The 2-dose vaccine effectiveness was not significantly lower for beneficiaries aged >80 years, for second doses received at ≥180 days, or for individuals with autoimmune conditions. The vaccine was also effective among individuals with immunosuppressive conditions. Two-dose vaccine effectiveness against postherpetic neuralgia was 76.0% (95% CI, 68.4–81.8).
Conclusions
This large real-world observational study of the effectiveness of Shingrix demonstrates the benefit of completing the 2-dose regimen. Second doses administered beyond the recommended 6 months did not impair effectiveness. Our effectiveness estimates were lower than the clinical trials estimates, likely due to differences in outcome specificity.
Knee osteoarthritis (KOA) is common in elderly people, causes pain, loss of physical functioning, and disability. This was a two-arm, superiority, quasi-experimental trial. The aim of this study was to evaluate the effectiveness of a home-based exercise intervention (HBEI) to reduce KOA symptoms and improve the physical functioning of elderly patients.
METHODS:
A total of 171 elderly patients (60 years of age or older) with KOA were recruited from four community centers. Patients from two community centers were randomly assigned to the intervention group (IG) and the other two centers were randomly assigned to the control group (CG). Participants in the IG received a 12-week HBEI (including four 2-h sessions supervised by a physiotherapist and fortnightly telephone support) combined with health education, while patients in the CG only received health education. The participants and physiotherapists were aware of the group assignment and alternative treatment components, but the study's hypotheses were not disclosed to the participants. Pain intensity, joint stiffness, lower-limb muscle strength, balance, mobility, and quality of life were measured before and after the intervention by the same blinded assessor.
RESULTS:
A total of 171 patients (IG: n = 84, CG: n = 87) were enrolled. Data were obtained from 141 patients with an average age of 68 (range, 60-86 years) who completed the 12-week study (IG: n = 71, CG: n = 70). No significant group differences were found in any outcome measures at baseline. At week 12, the pretest/posttest changes 3significant between-group differences in decreases in pain intensity (- 1.60 (CI, - 2.75 to - 0.58)) and stiffness (- 0.79 (CI, - 1.37 to - 0.21)), with the IG exhibiting significantly larger improvements on both measures than the CG. The IG also showed significantly greater improvements on all the secondary outcomes than the CG did.
CONCLUSIONS:
HBEI may be effective for relieving KOA symptoms, increasing the physical functioning, and improving quality of life in community-dwelling KOA elderly patients. A large randomized controlled trial with long-term follow-up is needed to confirm these findings.
