Personalised medicine needs different approach
REVISING the evidence-based medicine model to assess whether personalised therapies are effective is critically important as an increasing number of new targeted treatments for cancer become available, according to the authors of a “For debate” article in the MJA. The authors said the design of ethical studies and the promotion of opportunities for personalised medicine in the future were especially important when qualifying and quantifying the survival impact of targeted treatments such as those used in small populations defined by a biomarker. The authors used the examples of gefitinib and erlotinib, approved in 2004 and 2006, respectively, for the management of advanced non-small cell lung cancer (NSCLC). Since their approval, evidence has emerged that the drugs may be safer and more effective first-line treatments than chemotherapy in patients with NSCLC who have a specific gene mutation. “The development of erlotinib and gefitinib illustrates the limitations of privileging RCTs [randomised control trials] when trying to assess the benefits of targeted treatments”, the authors wrote. They said determining the cost-effectiveness of expensive new treatments was hindered by most RCT designs. “Understanding the overall survival impact and cost-effectiveness of new treatments will therefore require both new methodologies and new approaches to interpreting evidence”, they wrote.
Antibiotic prescribing still too high
RESEARCHERS in the US have found only incremental changes in antibiotic prescribing for adults with sore throat “despite decades of effort” to reduce prescribing rates. In a letter published online by JAMA Internal Medicine the researchers assessed 8191 sore throat visits by adults to primary care clinics and emergency departments (EDs) between 1997 and 2010. They found the proportion of primary care visits for sore throats declined from 7.5% in 1997 to 4.3% in 2010, but there was no change in ED visits (2.2% in 1997 to 2.3% in 2010). Physicians prescribed antibiotics in 60% of visits. The researchers said that based on previous analyses, the antibiotic prescribing rate had dropped from about 80% to 70% around 1993 and again to 60% around 2000, where it had remained stable. “This still far exceeds the 10% prevalence of GAS [group A Streptococcus] among adults seeking care for sore throat”, they wrote. “The prescription of broader-spectrum, more expensive antibiotics, especially azithromycin, was common. Prescribing of penicillin, which is guideline-recommended, inexpensive, well-tolerated, and to which GAS is universally susceptible, remained infrequent.” An accompanying editorial said use of antibiotics exposed patients without GAS infection to adverse effects without any benefit. “On a societal level, the increase in the use of antibiotics, particularly the broader-spectrum ones, accelerates the development of resistant organisms”, it said.
Little impact in ICU from gowning up
USING gloves and gowns for all patient contact in surgical and medical intensive care units (ICUs) does not reduce the acquisition of methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) compared with usual care, according to a randomised controlled trial published in JAMA. The researchers collected more than 90 000 surveillance swabs from 26 180 patients to assess the acquisition of MRSA or VRE as the primary outcome. They found that there was no statistically significant difference in the number of cases in ICUs where staff wore gloves and gowns compared with ICUs providing usual care, with a decrease in MRSA and VRE from 21.35 cases per 1000 patient days to 16.91 cases over the 9-month study period in the intervention ICUs compared with a reduction from 19.02 to 16.29 in the control ICUs. For key secondary outcomes there was no difference in VRE acquisitions with the intervention but MRSA cases did fall. The researchers described this finding as “surprising”. They also found no statistically significant effect on rates of adverse events with the intervention. An accompanying editorial said the study “serves as a poignant reminder that many questions remain for what constitutes best practice in the care of critically ill patients”.
Frequent GP visits protective for colorectal cancer
PATIENTS who frequently visit a primary care practitioner have lower colorectal cancer (CRC) incidence and mortality than those who rarely see their doctor, according to research published in the Annals of Internal Medicine. The large population-based case-control study included patients aged 67–85 years who were diagnosed with CRC matched with control patients (205 804 for CRC incidence, 54 160 for CRC mortality and 121 070 for all-cause mortality). The researchers checked on primary care visits in the 4–27 month period before CRC diagnosis, mortality and all-cause mortality. They found that patients who had 5–10 visits to a primary care practitioner had lower CRC incidence and mortality and lower all-cause mortality compared with patients who had one or no visits. The researchers said primary care helped to decrease CRC by promoting screening and facilitating referrals for colonoscopy and polypectomy. “Because a recommendation from primary care is one of the strongest predictors of adherence to CRC screening and several different options are available for CRC screening, access to primary care is important for counseling on these options”, they wrote.
Exercise can be as good as drugs
DESPITE a lack of randomised controlled trials (RCTs) on the effect of exercise interventions on mortality outcomes, researchers say existing trials suggest exercise is potentially as effective as drug interventions, in secondary prevention of coronary heart disease (CHD), rehabilitation after stroke, treatment of heart failure and prevention of diabetes. The research, published in the BMJ, included four meta-analyses based on exercise and 12 on drug interventions with a total of 305 randomised controlled trials with 339 274 participants. The authors said the research highlighted “the near absence of evidence on the comparative effectiveness of exercise and drug interventions on mortality outcomes”, with existing evidence on the mortality benefits of physical activity limited to the secondary prevention of CHD, rehabilitation after stroke, treatment of heart failure, and prevention of diabetes. There was also “a clear lack of exercise and drug comparisons: trials evaluating the effectiveness of pharmacotherapy rarely included physical activity as a comparator”. “Our findings reflect the bias against testing exercise interventions and highlight the changing landscape of medical research, which seems to increasingly favour drug interventions over strategies to modify lifestyle”, the researchers wrote. “The current body of medical literature largely constricts clinicians to drug options.”
Cognitive impairment risk high post ICU
COGNITIVE impairment after critical illness is common and can persist for up to a year, according to research published in the New England Journal of Medicine. The multicentre, prospective cohort study included a diverse population of 821 patients in general medical and surgical intensive care units (ICUs). The patients had a median age of 61 years and a high severity of illness, and included 6% with cognitive impairment at baseline. The researchers found that 74% of patients developed delirium during their hospital stay. They wrote that one in four patients still had cognitive impairment 12 months after critical illness “that was similar in severity to that of patients with mild Alzheimer’s disease, and one out of three had impairment typically associated with moderate traumatic brain injury”. Longer duration of delirium was independently associated with worse global cognition at 3 and 12 months and affected both old and young patients, regardless of the burden of coexisting conditions at baseline. An accompanying editorial said the data underscored the importance of surveillance and intervention for delirium in ICU practice. “This new knowledge provides detailed education for patients, families, ICU stakeholders, primary care physicians, and health policy makers and should fuel an informed discussion about what it means for our patients to survive an episode of critical illness, how it changes families forever, and when the degree of suffering and futility becomes unacceptable from a patient-centered and societal standpoint”, the editorial said.