A regular series on the latest clinical studies from around the world – and what they mean ‘in practice’, compiled and written by Claire GP Dr. Ray O’Connor
Although the COVID-19 pandemic has been less discussed in recent times, it is still having a great impact on healthcare. A theme emerging from recent research is that while vaccines cannot prevent infection, people who are vaccinated are less likely to get very sick or die. There are also many new forms of the virus with varying infectivity and severity. Current vaccines also provide a variable level of protection against these types. The duration of this protection is also unclear.
A retrospective observational US study1 It looked to see whether the increase in post-vaccination infections during the summer of 2021 was due to a decline in immunity over time, the emergence of the delta variant, or both. Researchers extracted data About vaccinations and outcomes related to COVID-19 during a nine-month period for approximately 10.6 million North Carolina residents. Their aim was to estimate the effectiveness of the Pfizer, Moderna, and Johnson & Johnson-Janssen vaccines. They concluded that all three COVID-19 vaccines had a sustainable effect in reducing the risk of hospitalization and death. The decrease in protection against infection over time was due to both a decline in immunity and the emergence of the delta variant.
A prospective observational study from the US2 Looked at this too. The authors concluded that mRNA vaccines belonging to alpha, delta and Omicron variants were found to be highly effective in preventing hospital admissions associated with COVID-19, but that three vaccine doses were needed to achieve protection against Omicron, which was two. The dosage was the same as the protection provided. Against Delta and Alpha variants. Vaccinated patients hospitalized with COVID-19 had significantly lower disease severity than unvaccinated patients for all variants.
Another observational study from Hong Kong showed similar results. During January-March 2022, it was reported that deaths related to COVID-19 rose sharply. Of these deaths, 96 percent occurred in persons aged 60 years. Within this age group, the risk of death was 20 times lower than in those who were not fully vaccinated.3
What about using different vaccines during vaccination? A paper from the American Center for Disease Control4 concluded that all eligible individuals should receive the recommended COVID-19 booster dose to prevent moderate to severe COVID-19. Adult Janssen primary vaccine recipients should preferably receive a heterogeneous mRNA vaccine (such as Pfizer or Moderna) booster dose no later than two months or later.
What about the fourth dose of the COVID vaccine? How effective is this? On 2 January 2022, Israel began giving the fourth dose of the Pfizer vaccine to individuals 60 years of age or older. The researchers estimated the rate of confirmed infections and severe COVID-19 after receiving the fourth dose, compared to those who received only three doses.5
They concluded that the rate of infection after the fourth dose of the vaccine was lower than after only three doses. Protection against confirmed infection appeared to be short-lived, while protection against serious illness did not decrease during the study period.
For those of us who have had a course of infection and a subsequent vaccine, what kind of protection does it provide against subsequent COVID infection? A team in the United Kingdom studied the duration and effectiveness of immunity in a prospective group of asymptomatic health workers.6
Vaccine effectiveness (ten months after or less than the first dose of vaccine) and immunity acquired from infection were assessed. They found that two doses of the Pfizer vaccine were associated with higher short-term protection against SARS-CoV-2 infection; After six months, this protection was significantly reduced. However, infection-acquired immunity, enhanced with vaccination, remained high for more than a year after infection.
More recently, we have started vaccinating children. another report from MMWR7 It was seen how effective it was during July 2021-February 2022. About half of omicron infections in unvaccinated children and adolescents were asymptomatic. Two doses of the Pfizer vaccine reduced the risk of Omicron infection by 31 percent in children aged 5-11 years and by 59 percent in individuals aged 12-15.
Finally, how safe are all these vaccines? A joint team from Barcelona and Oxford studied the risk of developing immune mediated neurological events with COVID-19 vaccines using primary care records from the UK and Spain.8 Records were studied of 8,330,497 people who received at least one dose of AstraZeneca, Pfizer, Moderna, or Johnson & Johnson-Janssen vaccines between the end of the vaccination campaigns rollout and data availability in June 2021.
The study concluded that no increased risk was observed between COVID-19 vaccines and immune mediated neurological events of Bell’s palsy, encephalomyelitis, Guillain-Barré syndrome and transverse myelitis. However, an increased risk was observed for people with SARS-CoV-2 infection.
- lin dy and others. ‘Effectiveness of COVID-19 vaccines over a 9-month period in North Carolina’, en eng j medi 2022;386:933-41.
- loring as and others. ,Clinical severity and effectiveness of mRNA vaccines against COVID-19 from Omicron, delta and alpha SARS-CoV-2 variants in the United States: prospective observational study, bmj 2022;376:E069761.
- Smith DJ and others. ‘COVID-19 mortality and vaccine coverage – Hong Kong Special Administrative Region, China, January 6, 2022–March 21, 2022’. MMWR / 8 April 2022 / Vol. 71.
- to Natarajan and others. 1 Ad.26.COV2.S (Efficacy of Homologous and Heterogeneous COVID-19 Booster Doses after Janssen) [Johnson & Johnson]Vaccine dosage against COVID-19-associated emergency department and urgent care encounters and hospitalization among adults – Vision Network, 10 States’, December 2021–March 2022. MMWR / 29 March 2022 / Vol. 71.
- bar-on ym and others. ‘Protection by a fourth dose of BNT162b2 against Omicron in Israel’, en eng j medi 2022 (published April 5).
- hall v and others for the siren group. ‘Protection against SARS-CoV-2 after COVID-19 vaccination and previous infection’, en eng j medi 2022;386:1207-20.
- Foulkes Ali and others. ‘Efficacy of a 2-dose BNT162b2 (Pfizer BioNtech) mRNA vaccine in preventing SARS-CoV-2 infection in children aged 5-11 years and adolescents aged 12-15 years – PROTECT cohort, July 2021-February 2022’ . MMWR / 18 March 2022 / Vol. 71/No.11.
- Lee X and others. ,Association between COVID-19 vaccination, SARS-CoV-2 infection and risk of immune mediated neurological events: a population-based cohort and self-controlled case series analysis, bmj 2022;376:E068373.
A new updated NICE guideline has just been published on AF. It is summarized BJGP,1
Significant changes to NICE’s new guideline support the use of the ORBIT Tool for Bleeding Risk Assessment to prescribe Directly Acting Oral Anticoagulants (DOACs) as a first-line anticoagulant for most patients.https://www.mdcalc.com/orbit-bleeding-risk-score-atrial-fibrillation), and taking a more holistic view of heart and stroke risk in patients with AF.
GPs are well placed to deliver such interventions for most patients, but should identify those with poorly controlled symptoms on rate control treatment or those with co-morbid disease, such as heart failure , who may benefit from referral to secondary care.
Breast pain is a common presentation in general practice. Many women are concerned that it could be a sign of cancer. This prospective UK cohort study looked at women who had a . is called Breast Diagnostic Clinic in 12 months.
There were 10,830 women in the study group, of whom 1,972 (18 percent) were referred with breast pain. In the breast pain group, the incidence of breast cancer was 0.4 percent, compared to 5 percent in each of the other diagnostic groups. Compared to reassurance in primary care, referral was more expensive without additional health benefits.
The authors conclude that referring women with breast pain to a breast diagnosis clinic is an inefficient use of limited resources.
It sounds doable, but can you really lose weight by sleeping? Short sleep duration has been recognized as a risk factor for obesity. Does increasing sleep duration reduce this risk?
Researchers in Chicago conducted a randomized controlled clinical trial on a group of 80 adults aged 21 to 40 years with a body mass index between 25.0 and 29.9 and whose habitual sleep duration was less than 6.5 hours per night.
After a 2-week baseline, participants were randomized to either a personalized sleep hygiene counseling session, aimed at increasing their sleep time by 8.5 h (sleep extension group), or to their habitual sleep (control) group) was to continue.
There was an increase in sleep duration of approximately 1.2 hours per night in the sleep extension group versus the control group. There was a significant reduction in energy intake in the sleep extension group compared to the control group. Change in sleep duration was inversely correlated with change in energy intake.
Participants in the sleep extension group had a statistically significant reduction in weight compared to the control group (−0.87 kg). Weight gain was observed from baseline in the control group (0.39 kg). The findings suggest that improving and maintaining adequate sleep duration can reduce weight and be a viable intervention for obesity prevention and weight loss programs.
About one in four women with a UTI episode will have recurrent recurrences, representing a significant global health problem. Long-term, low-dose daily antibiotic treatment is the current standard of care for prophylaxis in women with recurrent urinary tract infections. infection. Despite the perceived success of prophylactic antibiotics, antimicrobial resistance has been directly linked to antibiotic consumption; As a result, the importance of research into non-antibiotic alternatives is highlighted. This study was a multicentre, open label, randomized, non-inferiority trial based at eight centers in the UK.1
Participants were women 18 years of age with recurrent urinary tract infections requiring prophylactic treatment. The aim was to test and compare the efficacy of methenamine hippurate (Hiprex) for the prevention of recurrent urinary tract infections with the current standard prophylaxis of daily low-dose antibiotics.
Methenamine hippurate is a non-antibiotic treatment, which is hydrolyzed to formaldehyde in an acidic environment such as in the distal tubules of the kidney. Formaldehyde is bactericidal. The incidence of antibiotic-treated urinary tract infections during the 12-month treatment period was 0.89 episodes per person per year in the antibiotics group and 1.38 in the methenamine hippurate group, with an absolute difference of 0.49 confirming non-inferiority. The conclusion of the study was that non-antibiotic prophylactic treatment with methenamine hippurate may be appropriate for such women.
It is good to have such an option available, as one of the recommended prophylactic antibiotics, nitrofurantoin, has been shown to be associated with liver and lung toxicity when prescribed over a long period of time. Monitoring of treatment is advised. A study from Bristol, England evaluated how nitrofurantoin was prescribed and monitored in primary and secondary care.2 Less than 10 percent of prescribers who were regularly monitored had a low level of awareness of the potential for injury.
- harding c and others. ,Choice of prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicenter, open label, randomized, non-inferiority trial, bmj 2022;376:e068229.
- spear teepee and others. ‘Long-term nitrofurantoin: complication awareness, monitoring and analysis of pulmonary injury cases’, BJGP Open 2021.