In the News

Communicating cancer diagnoses, guidance on prescribing clopidogrel, and more.

Cancer diagnoses often given quickly, impersonally

Almost 20% of cancer patients are informed of their diagnosis over the phone, and almost half are told in a conversation lasting less than 10 minutes, according to a survey.

The data were gathered from a questionnaire given to 460 oncology patients being treated at the National Institutes of Health (NIH) Clinical Center in Bethesda, Md. The surveyed patients had been referred to the NIH from around the U.S. and some foreign countries, and slightly more than a third of them had lymphoma and leukemia. Another 22% had brain cancer, 14% had prostate cancer and 27% had some other type of cancer.

More than half of the patients (54%) reported learning of their cancer diagnosis in a physician's office, while 18% learned over the phone and 28% were told in the hospital. Of the patients who were diagnosed in the hospital, 43% got the news in their room, 23% in the emergency department, 13% in the recovery room, 7% in the radiology department and 13% in other locations, including one patient who discovered the diagnosis by reading a radiology report.

As for the length of the conversation, 8% said it was less than a minute, 36% between 1 and 10 minutes, and 35% 11 to 30 minutes. About 30% of patients said there was no discussion of treatment options. The survey also asked how satisfied patients were with the way they were informed, and being informed in person and during a longer discussion were associated with greater satisfaction. Patients also reported anecdotes of the conversations, describing notifications that were left on answering machines or made on holidays.

The study authors acknowledged that some situations may require notification over the phone or in an impersonal location like an emergency department, but “having more than 20% of patients told their diagnosis in an impersonal manner suggests too many physicians are either unaware of or not practicing good communication skills,” they said. They recommended that the delivery of a cancer diagnosis be done face-to-face in a personal setting, last longer than 10 minutes, and include additional information beyond just the diagnosis, such as treatment options.

Patients who don't get such a conversation may be not only more dissatisfied with the experience, but also more likely to change physicians after the diagnosis. More than half of the studied patients changed physicians—many because of a referral—but 10% gave poor communication as a reason for switching and 12% cited general dissatisfaction. The study was published in the Aug. 1, 2010 issue of the Journal of Clinical Oncology.

Specialist groups issue clinical alert to guide clopidogrel prescribers

Two cardiology groups released a clinical alert to guide doctors prescribing clopidogrel after the FDA added a boxed warning to the label about genetic variations that affect the drug's efficacy.

The FDA estimates that 2% to 14% of patients poorly metabolize clopidogrel (Plavix). Although there is increasing information about specific genetic variations that might affect metabolism, the agency says there is not sufficient evidence to develop specific recommendations related to genetic testing in patients.

In light of the FDA warning, the American College of Cardiology (ACC) Foundation and the American Heart Association (AHA) issued a statement outlining key issues to consider and recommendations last June for practice. The statement said that:

  • Evidence-based guidelines from the ACC, AHA or other professional societies for using antiplatelet therapies should remain the foundation of care. If clopidogrel is prescribed, clinicians should ensure that patients take it as prescribed.
  • Clinicians must be aware that in certain patients with either acute or chronic coronary artery disease, genetic variability in response to clopidogrel can affect its inhibition of platelet function.
  • Careful clinical judgment, including weighing the risks and benefits, is needed in considering all therapies. The new boxed warning points out that for clopidogrel, if there is a lack of efficacy, the outcome could be fatal.
  • Results from ongoing clinical trials in large groups of patients will provide more information about the predictive value of genetic testing and better inform the role genotyping might play in personalizing medicine and optimizing outcomes.
  • Genetic testing to determine if a patient is a “poor metabolizer” may be considered before starting clopidogrel therapy in patients believed to be at moderate or high risk for poor outcomes, such as patients undergoing elective high-risk percutaneous coronary intervention procedures.
  • Using alternative antiplatelet therapies or altering the dosing of clopidogrel may be reasonable options in patients who experience an adverse event while taking clopidogrel and who have been taking the drug as prescribed.

The statement authors cautioned that patients currently taking clopidogrel should not stop the drug unless advised by their clinician.

Post-op infection rates decline with adherence to two or more prevention measures

Adherence to at least two of six postoperative infection-prevention measures appears to lower infection rates, but adherence to individual measures doesn't seem to make a difference, a study found.

In a retrospective cohort study, researchers examined data from an inpatient administrative database to determine the outcome of self-reported adherence to national quality measures. The measures studied were the six publicly reported measures from the Surgical Care Improvement Project (SCIP) that focus on postoperative infection prevention. The data represent 405,720 discharges from 398 hospitals with at least one reported SCIP quality measure between July 1, 2006 and March 31, 2008. In addition to item-level analysis, the measures were aggregated into two all-or-none measures of adherence. The S-INF-Core represents patients who were eligible for the original three SCIP measures, which deal with the use of antibiotics. The S-INF represents patients with any two (or more) recorded SCIP measures of the six. Results were reported in the June 23/30, 2010 Journal of the American Medical Association.

Adherence to the S-INF composite measure significantly decreased postoperative infection rates from 14.2 to 6.8 per 1,000 discharges (adjusted odds ratio [AOR], 0.85; 95% CI, 0.76 to 0.95), while the decrease with adherence to the S-INF-Core composite wasn't significant (11.5 to 5.3 per 1,000 discharges; AOR, 0.86; 95% CI, 0.74 to 1.01). No individual SCIP measure significantly lowered the probability of infection. Adherence to these individual measures is reported to the public via the Hospital Compare website.

Given that individual measures don't appear to lower infection rates, reporting adherence to them doesn't “fulfill their stated purpose of pointing consumers toward high-quality hospitals,” the authors noted. Further, reporting individual measures is a component of the Centers for Medicare and Medicaid Services' value-based purchasing initiatives, yet this study's data suggest “that implementing incentive-based reimbursement schemes on these individual items would do little to further improve hospital quality,” the authors wrote.

Still, the success of using aggregate measures in lowering infection rates suggests there is some association between SCIP adherence and quality. “Improved individual process-of-care measures and use of aggregation techniques in addition to improved data collection methods may be necessary to truly drive improvements in patient outcomes,” the researchers concluded.

AIDS society updates antiretroviral treatment recommendations for U.S. adults

New data about untreated HIV and expanded treatment options led a panel to update recommendations for antiretroviral therapy (ART) in U.S. adults.

The International AIDS Society-USA guidelines recommend when to start ART, what type to choose, how to monitor and when to change therapies. Recommendations appeared in the July 21, 2010 issue of the Journal of the American Medical Association.

Patients must be ready to undertake lifelong ART, the guidelines said. Therapy is recommended for symptomatic patients regardless of CD4 cell count, and for asymptomatic individuals with CD4 cell counts ≤500/µL. Risk reduction counseling should be done at each patient-clinician interaction, they said.

When selecting a regimen, clinicians should consider resistance-testing results and predicted virologic efficacy, toxicity and tolerability; pill burden; dosing frequency; drug-drug interactions; comorbidities; patient and practitioner preference; and cost and affordability. Current evidence supports combining two nucleoside reverse transcriptase inhibitors (nRTIs) and a potent third agent from another class. Fixed-dose formulations and once-daily regimens are preferred.

Effective therapy should suppress HIV to less than 50 copies/mL (polymerase chain reaction) or 75 copies/µL (branched DNA) by 24 weeks. To detect failure, testing of HIV-1 RNA should be repeated two to eight weeks after initiation, every four to eight weeks until suppressed, and then every three to four months for at least the first year. CD4 cell counts should be monitored at least every three to four months after starting therapy, especially among patients with counts <200/µL, to assess prophylaxis for opportunistic infections.

Patients who have changed therapy because of virologic failure need more frequent monitoring. Even if one or more regimens has failed, the therapeutic goal should still be undetectable plasma HIV-1 RNA levels. This goal is achievable with new drugs and regimens, the guidelines said.

Before changing regimens following a rebound after complete suppression, physicians should consider poor adherence, drug-drug interactions, concurrent infections and recent vaccinations as possible causes. Testing for an isolated detectable viral load should be repeated to exclude errors or self-resolving low-level viremia.

When changing regimens, physicians should consider the stage of HIV, nadir and current CD4 cell count, comorbidities, treatment history, current and previous drug resistance tests, and drug interactions. At least two drugs, and preferably three fully active drugs, should be included and drugs from new classes should be considered.

Single-agent switches to decrease toxicity, avoid drug interactions, or improve convenience and adherence are possible, provided the potency of the regimen is maintained and drug interactions are managed. Ritonavir-boosted protease inhibitor (PI/r) monotherapy is not recommended, except when other drugs raise issues of toxicity or tolerability. Delaying such switches may affect adherence and risk developing resistance.