General practice case studies

NHS England has published the following case studies relating to general practice:

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Chronic obstructive pulmonary disease pathway

NHS RightCare has published RightCare Pathway: COPD.  This pathway defines the core components of an optimal service for people with chronic obstructive pulmonary disease (COPD).  It includes resources to support local health economise to concentrate their improvement efforts where there is greatest opportunity to address variation and improve population health.  It contains a number of key messages for commissioners.

Additional link: NHS England press release

Association of Gestational Weight Gain With Maternal and Infant Outcomes

Question  What is the association between gestational weight gain above or below the Institute of Medicine guidelines and maternal and infant outcomes?

Findings  In this systematic review and meta-analysis of 1 309 136 pregnancies, gestational weight gain below recommendations (in 23% of women) was associated with higher risk of small for gestational age (odds ratio [OR], 1.53) and preterm birth (OR, 1.70) and lower risk of large for gestational age (OR, 0.59) and macrosomia (OR, 0.60). Gestational weight gain above recommendations (47%) was associated with lower risk of small for gestational age (OR, 0.66) and preterm birth (OR, 0.77) and higher risk of large for gestational age (OR, 1.85), macrosomia (OR, 1.95), and cesarean delivery (OR, 1.30).

Meaning  Gestational weight gain below or above the Institute of Medicine guidelines was associated with higher risk of some adverse maternal and infant outcomes.

Reference: JAMA. 2017;317(21):2207-2225.

Oral Glucocorticoid–Sparing Effect of Benralizumab in Severe Asthma

BACKGROUND

Many patients with severe asthma rely on oral glucocorticoids to manage their disease. We investigated whether benralizumab, a monoclonal antibody directed against the alpha subunit of the interleukin-5 receptor that significantly reduces the incidence of asthma exacerbations, was also effective as an oral glucocorticoid–sparing therapy in patients relying on oral glucocorticoids to manage severe asthma associated with eosinophilia.

METHODS

In a 28-week randomized, controlled trial, we assessed the effects of benralizumab (at a dose of 30 mg administered subcutaneously either every 4 weeks or every 8 weeks [with the first three doses administered every 4 weeks]) versus placebo on the reduction in the oral glucocorticoid dose while asthma control was maintained in adult patients with severe asthma. The primary end point was the percentage change in the oral glucocorticoid dose from baseline to week 28. Annual asthma exacerbation rates, lung function, symptoms, and safety were assessed.

RESULTS

Of 369 patients enrolled, 220 underwent randomization and started receiving benralizumab or placebo. The two benralizumab dosing regimens significantly reduced the median final oral glucocorticoid doses from baseline by 75%, as compared with a reduction of 25% in the oral glucocorticoid doses in the placebo group (P<0.001 for both comparisons). The odds of a reduction in the oral glucocorticoid dose were more than 4 times as high with benralizumab as with placebo. Among the secondary outcomes, benralizumab administered every 4 weeks resulted in an annual exacerbation rate that was 55% lower than the rate with placebo (marginal rate, 0.83 vs. 1.83, P=0.003), and benralizumab administered every 8 weeks resulted in an annual exacerbation rate that was 70% lower than the rate with placebo (marginal rate, 0.54 vs. 1.83, P<0.001). At 28 weeks, there was no significant effect of either benralizumab regimen on the forced expiratory volume in 1 second (FEV1), as compared with placebo. The effects on various measures of asthma symptoms were mixed, with some showing significant changes in favor of benralizumab and others not showing significant changes. Frequencies of adverse events were similar between each benralizumab group and the placebo group.

CONCLUSIONS

Benralizumab showed significant, clinically relevant benefits, as compared with placebo, on oral glucocorticoid use and exacerbation rates. These effects occurred without a sustained effect on the FEV1. (Funded by AstraZeneca; ZONDA ClinicalTrials.gov number, NCT02075255.)

Reference: N Engl J Med 2017; 376:2448-2458June 22, 2017

Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older

BACKGROUND

Improved influenza vaccines are needed to control seasonal epidemics. This trial compared the protective efficacy in older adults of a quadrivalent, recombinant influenza vaccine (RIV4) with a standard-dose, egg-grown, quadrivalent, inactivated influenza vaccine (IIV4) during the A/H3N2-predominant 2014–2015 influenza season, when antigenic mismatch between circulating and vaccine influenza strains resulted in the reduced effectiveness of many licensed vaccines.

METHODS

We conducted a randomized, double-blind, multicenter trial of RIV4 (45 μg of recombinant hemagglutinin [HA] per strain, 180 μg of protein per dose) versus standard-dose IIV4 (15 μg of HA per strain, 60 μg of protein per dose) to compare the relative vaccine efficacy against reverse-transcriptase polymerase-chain-reaction (RT-PCR)–confirmed, protocol-defined, influenza-like illness caused by any influenza strain starting 14 days or more after vaccination in adults who were 50 years of age or older. The diagnosis of influenza infection was confirmed by means of RT-PCR assay and culture of nasopharyngeal swabs obtained from participants with symptoms of an influenza-like illness. The primary end point was RT-PCR–confirmed, protocol defined, influenza-like illness between 14 days or more after vaccination and the end of the influenza season.

RESULTS

A total of 9003 participants were enrolled and underwent randomization; 8855 (98.4%) received a trial vaccine and underwent an efficacy follow-up (the modified intention-to-treat population), and 8604 (95.6%) completed the per-protocol follow-up (the modified per-protocol population). Among RIV4 recipients, the RT-PCR–confirmed influenza attack rate was 2.2% (96 cases among 4303 participants) in the modified per-protocol population and 2.2% (96 cases among 4427 participants) in the modified intention-to-treat population. Among IIV4 recipients, the attack rate was 3.2% (138 cases among 4301 participants) in the modified per-protocol population and 3.1% (138 cases among 4428 participants) in the modified intention-to-treat population. A total of 181 cases of influenza A/H3N2, 47 cases of influenza B, and 6 cases of nonsubtypeable influenza A were detected. The probability of influenza-like illness was 30% lower with RIV4 than with IIV4 (95% confidence interval, 10 to 47; P=0.006) and satisfied prespecified criteria for the primary noninferiority analysis and an exploratory superiority analysis of RIV4 over IIV4. The safety profiles of the vaccines were similar.

CONCLUSIONS

RIV4 provided better protection than standard-dose IIV4 against confirmed influenza-like illness among older adults. (Funded by Protein Sciences; ClinicalTrials.gov number, NCT02285998.)

Reference: N Engl J Med 2017; 376:2427-2436June 22, 2017